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Effects of a group-based compassion microintervention compared to cognitive reappraisal training on cardiovascular, self-reported, and behavioral stress reactivity among young adults: A cluster randomized controlled trial.

Heightened stress reactivity, particularly heightened blood pressure (BP) reactivity, during emerging adulthood predicts future adverse cardiovascular health. Coping skill interventions for young adults may buffer against stress reactivity. This study tested the stress-buffering effects of a group-based 40-min compassion skills microintervention compared to a time-matched cognitive behavior therapy (CBT) skills control group. The compassion intervention included psychoeducation about compassion and a guided practice focused on cultivating compassion for a close other and for the self. The CBT

Efficacy of pericapsular nerve group block (PENG) compared to local infiltration analgesia (LIA) after total hip arthroplasty: a systematic review and meta-analysis of randomized controlled trials.

PURPOSE: Pain management after total hip arthroplasty (THA) is crucial for patient recovery and satisfaction. Various analgesic techniques exist, including the pericapsular nerve group (PENG) block and local infiltration analgesia (LIA). This study aims to compare the efficacy of PENG and LIA in postoperative pain management following THA. METHODS: A random-effects meta-analysis of randomized controlled trials (RCTs) comparing PENG and LIA in primary THA was conducted. A systematic search of MEDLINE, Embase, Cochrane Library, and SCOPUS was performed up to October 24, 2024. Pain scores, opioi

A park-based group mobility program for older adults with difficulty walking outdoors: a qualitative process evaluation of the Getting Older Adults Outdoors (GO-OUT) randomized controlled trial.

BACKGROUND: The Getting Older Adults Outdoors (GO-OUT) randomized controlled trial showed that a workshop and 10-week park-based outdoor walk group (OWG) was superior to the workshop and 10 weekly reminders (WR) with increasing walking capacity, but not outdoor walking activity, health-promoting behavior, or successful aging, among older adults with difficulty walking outdoors. The objective of this planned process evaluation was to explore participants' perceptions of mechanisms of impact of and contextual factors influencing experiences with the interventions to help explain the observed int

Suppressive effect of myristic acid on postprandial blood glucose elevation in healthy adults with high blood glucose levels: A double-blinded, randomized, placebo-controlled, parallel-group study.

BACKGROUND AND AIMS: Long-term oral administration of myristic acid has been shown to ameliorate hyperglycemia in a mouse model of type 2 diabetes (Nagoya-Shibata-Yasuda mice). However, its effects on human hyperglycemia remains unclear. This study aimed to evaluate the effects of myristic acid on postprandial blood glucose levels in healthy adults with high blood glucose levels. METHODS: This randomized, double-blinded, placebo-controlled clinical trial assigned 100 healthy individuals with high postprandial blood glucose levels (maximum postprandial blood glucose concentration (Cmax) in the

Clinical effectiveness of the Circle of Security-Parenting group intervention for birthing parents in perinatal mental health services in England (COSI): a pragmatic, multicentre, assessor-masked, randomised controlled trial.

BACKGROUND: Perinatal mental health difficulties are common and, if untreated, are associated with long-term adverse child outcomes. Substantial evidence gaps exist in group-based and parent-infant interventions for perinatal mental health difficulties. Circle of Security-Parenting (COS-P) groups have shown preliminary efficacy, although previous studies were methodologically weak or not specific to relevant populations. This study aimed to evaluate whether the hybrid delivery of COS-P plus treatment-as-usual reduces psychopathology in birthing parents accessing National Health Service communi

Effect of mini-open rotator cuff repair combined with intraoperative cocktail therapy in the treatment of rotator cuff injury: a prospective comparative study between the cocktail therapy and the control group.

INTRODUCTION: To investigate the clinical effect of mini-open rotator cuff repair combined with intraoperative cocktail therapy in the treatment of rotator cuff injury. METHODS: A prospective comparative study of 78 patients with rotator cuff injury who underwent mini-open rotator cuff repair in our hospital from January 2020 to January 2022 and used block randomization to divide patients into 2 groups in this trial: The cocktail group received 150 mg ropivacaine, 40 mg of methylprednisolone succinate, 0.3 mg of epinephrine, and saline solution to a total of 100 mL, whereas the control group

Randomised, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of antibiotic faecal microbiota transplantation in patients with Parkinson's disease (FLORA-PD): a study protocol.

INTRODUCTION: The intestinal microbiota of people with Parkinson's disease (PwP) differs significantly from that of healthy individuals. Given that altered microbiota may play a role in the pathogenesis of Parkinson's disease, faecal microbiota transplantation (FMT) has been proposed as a potential therapeutic approach. However, the efficacy of FMT in improving motor symptoms in PwP has been inconclusive in some pilot randomised controlled trials (RCT). Previous RCTs on PwP employed simple FMT, but our modified approach-pretreatment with antibiotics before FMT (A-FMT)-has been shown to improve

Distribution of nailfold videocapillaroscopy parameters in systemic lupus erythematosus and their association with disease activity: an international blinded case-control analysis on behalf of the EULAR study group on microcirculation in rheumatic diseases.

OBJECTIVES: To evaluate whether patients with systemic lupus erythematosus (SLE) have different nailfold videocapillaroscopy (NVC) findings compared with healthy controls (HCs) and whether there is an association between NVC abnormalities and disease activity, clinical and/or laboratory features in SLE. METHODS: This is an observational, multicentre, international, matched case-control study. 381 subjects (203 patients with SLE and 178 HCs) were enrolled from 16 centres in 10 countries. Clinical and laboratory data were collected using ad hoc forms. 5861 NVC images were acquired, coded and up

Effectiveness of Kushal Maa, a group-based mhealth interactive education and social support intervention for maternal and neonatal health outcomes: study protocol for a multisite randomised controlled trial in India.

INTRODUCTION: Perinatal care continuity across the full continuum is essential for optimising maternal and infant health; however, a stark gap occurs post partum, with less than one half of Indian mothers receiving postpartum care due to significant logistical and sociocultural barriers, particularly for periurban and rural residents. To overcome these barriers and reduce women's postpartum isolation, our international team of maternal and infant health clinicians and researchers developed and pilot-tested a culturally-tailored mobile interactive education and support group intervention, Kusha

Обоснование 4-month, параллельные, выборочно контролируемые испытания для оценки осуществимости и эффективности дистанционного обучения испаноязычных/латиноязычных лиц с множественным склерозом (FERLA MS).

ИСТОРИЯ ВОПРОСА: Испаноязычные/латиноязычные лица с множественным склерозом (МС) сталкиваются с бóльшим бременем болезней и коморбидностью из-за ограниченного доступа к медицинскому обслуживанию, недостаточной представленности в научных исследованиях и социальных факторов, определяющих состояние здоровья (SDOH). Профессиональная подготовка могла бы способствовать достижению результатов в области здравоохранения, однако в существующих исследованиях, посвященных мерам вмешательства, не представлены испаноязычные/латиноязычные страны. МЕТОДЫ: Мы предлагаем провести технико-экономическое обоснован

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… The study will consist of an exercise intervention group that completes aerobic and resistance training exercises, and an active control group that completes flexibility training exercises. … We will record all monetary costs for the study; for both the intervention and control groups c. None; this will provide information on communication frequency, quality, and highlight communication problems d. …

Efficacy and safety of infliximab or adalimumab in severe mucocutaneous Behçet's syndrome refractory to traditional immunosuppressants: a 6-month, multicentre, randomised controlled, prospective, parallel group, single-blind trial.

INTRODUCTION: Evidence from randomised controlled trials on anti-tumour necrosis factor (TNF) agents in patients with Behçet's syndrome (BS) is low. METHOD: We conducted a phase 3, multicentre, prospective, randomised, active-controlled, parallel-group study to evaluate the efficacy and safety of either infliximab (IFX) or adalimumab (ADA) in patients with BS. Adults patients with BS presenting with active mucocutaneous manifestations, occurring while on therapy with either azathioprine or cyclosporine for at least 3 months prior to study entry, were eligible. Participants were randomly assig

A Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Phase 2 Study Evaluating the Efficacy and Safety of GN-037 Cream in Patients with Mild-to-Moderate Plaque Psoriasis.

INTRODUCTION: Topical therapies are used in almost all patients with psoriasis. A novel fixed topical combination cream (GN-037) with a lower concentration (0.0356%) of clobetasol 17-propionate (CP) was developed together with urea, salicylic acid, and retinoic acid to provide a better benefit-risk ratio. The present multicenter randomized double-blind vehicle-controlled parallel group phase 2 study aimed to investigate the efficacy and safety of GN-037 in patients with mild-to-moderate plaque psoriasis (MMPP). METHODS: Patients (n = 190) were randomized (2:2:1) to receive GN-037 or CP or veh

Feasibility and Preliminary Effects of a Social Media-Based Peer-Group Mobile Messaging Smoking Cessation Intervention Among Chinese Immigrants who Smoke: Pilot Randomized Controlled Trial.

BACKGROUND: Chinese immigrants experience significant disparities in tobacco use. Culturally adapted tobacco treatments targeting this population are sparse and the use is low. The low use of these treatment programs is attributed to their exclusive focus on individuals who are ready to quit and the wide range of barriers that Chinese immigrants face to access these programs. To support Chinese immigrant smokers at all levels of readiness to quit and address their access barriers, we developed the WeChat Quit Coach, a culturally and linguistically appropriate WeChat (Tencent Holdings Limited)-

The impact of telemonitoring on correct drug use, complications and quality of life among patients with multiple myeloma (ITUMM): A study protocol for an open-label, parallel-group, randomized controlled trial.

INTRODUCTION: Multiple myeloma (MM) is the second most common hematologic malignancy. MM is associated with significant morbidity due to its end-organ destruction and is a disease of the older population. Although survival rates for MM have improved over the last decade, due to an increase in treatment options, the disease remains incurable. Expensive (oral) agents are widely used in MM patients; however, tools for supporting patients in complex treatment regimens are scarce. To investigate if a tool will support MM patients and healthcare professionals, the MM e-coach was developed and tested

Efficacy and safety of an early oral switch in low-risk Staphylococcus aureus bloodstream infection (SABATO): an international, open-label, parallel-group, randomised, controlled, non-inferiority trial.

BACKGROUND: Staphylococcus aureus bloodstream infection is treated with at least 14 days of intravenous antimicrobials. We assessed the efficacy and safety of an early switch to oral therapy in patients at low risk for complications related to S aureus bloodstream infection. METHODS: In this international, open-label, randomised, controlled, non-inferiority trial done in 31 tertiary care hospitals in Germany, France, the Netherlands, and Spain, adult patients with low-risk S aureus bloodstream infection were randomly assigned after 5-7 days of intravenous antimicrobial therapy to oral antimic

Antipsychotic dose reduction and discontinuation versus maintenance treatment in people with schizophrenia and other recurrent psychotic disorders in England (the RADAR trial): an open, parallel-group, randomised controlled trial.

BACKGROUND: Maintenance antipsychotic medication is recommended for people with schizophrenia or recurrent psychosis, but the adverse effects are burdensome, and evidence on long-term outcomes is sparse. We aimed to assess the benefits and harms of a gradual process of antipsychotic reduction compared with maintenance treatment. Our hypothesis was that antipsychotic reduction would improve social functioning with a short-term increase in relapse. METHODS: RADAR was an open, parallel-group, randomised trial done in 19 National Health Service Trusts in England. Participants were aged 18 years a

The effect of Lu AG09222 on PACAP38- and VIP-induced vasodilation, heart rate increase, and headache in healthy subjects: an interventional, randomized, double-blind, parallel-group, placebo-controlled study.

BACKGROUND: Pituitary adenylate cyclase-activating polypeptide (PACAP), structurally related to vasoactive intestinal peptide (VIP), is one of the important mediators in the pathogenesis of migraine and is known to dilate cranial arteries and induce headache and migraine. Our objective was to determine whether Lu AG09222-an investigational humanized monoclonal antibody directed against PACAP ligand-would inhibit the PACAP-signaling cascade by abolishing its vasodilatory and headache-inducing abilities. METHODS: In a randomized, double-blind, parallel-group, single-dose, placebo-controlled stu

A park-based group mobility program for older adults with difficulty walking outdoors: a quantitative process evaluation of the Getting Older Adults Outdoors (GO-OUT) randomized controlled trial.

BACKGROUND: Process evaluations of randomized controlled trials (RCTs) of community exercise programs are important to help explain the results of a trial and provide evidence of the feasibility for community implementation. The objectives of this process evaluation for a multi-centre RCT of outdoor walking interventions for older adults with difficulty walking outdoors, were to determine: 1) implementation fidelity (the extent to which elements of the intervention were delivered as specified in the original protocol) and 2) participant engagement (the receipt of intervention components by the

Comparative efficacy of Micropore™ surgical dressing, Tegaderm™ and Lockit plus® for lumbar epidural catheter fixation in children: a prospective parallel group randomized controlled trial.

BACKGROUND: Proper fixation of an epidural catheter is necessary for desired drug effect and to prevent catheter displacement. Different techniques have been used for epidural catheter fixation. The aim of the study was to compare the relative efficacy of Micropore™ surgical dressing, Tegaderm™, and Lockit plus® in preventing lumbar epidural catheter migration in children. METHODS: We studied 167 patients aged 5-16 years, for up to 48 h. After the elective abdominal or lower limb surgery. Patients were randomly assigned to one of three groups: (1) Micropore™ surgical dressing (group M), (2) T

Analgesic efficacy of Pericapsular Nerve Group (PENG) block compared with Fascia Iliaca Block (FIB) in the elderly patient with fracture of the proximal femur in the emergency room. A randomised controlled trial.

INTRODUCTION AND OBJECTIVES: Data on the efficacy of PENG (Pericapsular Nerve Group) block in hip trauma pain are scarce. We hypothesized that PENG block was more effective than infra-inguinal ultrasound-guided FIB (Fascia Iliaca block) for pain control in patients aged 65 years or older presenting in the emergency room (ER) with traumatic proximal femoral fracture. MATERIALS AND METHODS: We conducted an exploratory, double-blind, randomized controlled trial. One anaesthesiologist performed the block and another assessed outcomes. Patients were randomly allocated to the PENG group (20 ml ropi