14,354 results match your criteria 6-month randomized


Effects of multi-domain lifestyle interventions on sarcopenia measures and blood biomarkers: secondary analysis of a randomized controlled trial of community-dwelling pre-frail and frail older adults.

Aging (Albany NY) 2021 Mar 19;13(7):9330-9347. Epub 2021 Mar 19.

Gerontology Research Programme, Department of Psychological Medicine, National University Health System, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.

Few studies have comprehensively described changes in blood biomarkers of the physiological responses underlying sarcopenia reduction associated with lifestyle interventions. In this study, we performed secondary analyses of data in a randomized controlled trial of multi-domain lifestyle interventions (6-month duration physical exercise, nutritional enrichment, cognitive training, combination and standard care control) among 246 community-dwelling pre-frail and frail elderly, aged ≥65 years, with and without sarcopenia. Appendicular lean mass (ALM), lower limb strength, gait speed, and blood levels of markers of muscle metabolism, inflammation, anti-oxidation, anabolic hormone regulation, insulin signaling, tissue oxygenation were measured at baseline, 3-month and 6-month post-intervention. Read More

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Effect of acupotomy in knee osteoarthritis patients: study protocol for a randomized controlled trial.

Trials 2021 Apr 20;22(1):295. Epub 2021 Apr 20.

The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.

Background: Symptomatic knee osteoarthritis (KOA) is common in China. Pharmacological therapy is not the first recommendation because of its safety issues. Nonpharmacological therapy, such as lifestyle adjustments, weight loss, muscle strengthening, and aerobic exercise programs, is strongly recommended for KOA. Read More

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Is Comprehensive Geriatric Assessment Admission Avoidance Hospital at Home an Alternative to Hospital Admission for Older Persons? : A Randomized Trial.

Ann Intern Med 2021 Apr 20. Epub 2021 Apr 20.

University of Leeds, Leeds, United Kingdom (J.Y.).

Background: Delivering hospital-level care with comprehensive geriatric assessment (CGA) in the home is one approach to deal with the increased demand for bed-based hospital care, but clinical effectiveness is uncertain.

Objective: To assess the clinical effectiveness of admission avoidance hospital at home (HAH) with CGA for older persons.

Design: Multisite randomized trial. Read More

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Duration of Antiplatelet Therapy Following Transcatheter Aortic Valve Replacement: Systematic Review and Network Meta-Analysis.

J Am Heart Assoc 2021 Apr 17:e019490. Epub 2021 Apr 17.

Division of Cardiovascular Medicine New York University School of Medicine New York NY.

Background Although current guidelines recommend dual antiplatelet therapy (DAPT) for 3 to 6 months following transcatheter aortic valve replacement (TAVR), there are no studies directly comparing outcomes of different durations of DAPT following TAVR. Methods and Results PubMed, EMBASE, and Cochrane Database were searched through November 2020 to identify clinical studies that investigated single antiplatelet therapy versus DAPT use following TAVR. Studies using oral anticoagulants and antiplatelet therapy concomitantly were excluded. Read More

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Evaluation of the effect of the lateralized inferior alveolar nerve isolation and bone grafting on the nerve function and implant stability. (Randomized Clinical Trial).

Clin Implant Dent Relat Res 2021 Apr 18. Epub 2021 Apr 18.

Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University, Cairo, Egypt.

Background: The inferior alveolar nerve lateralization (IANL), although allows for an implant full-length mandibular height engagement, coincides with depleting the buccal bone support and sensory deficits.

Purpose: This study aims to assess whether interposing a bone graft coupled with securing a collagen membrane separation between the inferior alveolar nerve (IAN) and the underlying dental implants would preserve the nerve function, enhance the implant stability, and minimize the radiographic marginal bone loss.

Material And Methods: Eighteen patients with 30 atrophic mandibular edentulous ridges were subjected to IANL after being randomly assigned to two treatment modalities which consisted of 15 patients each. Read More

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Percutaneous microwave ablation versus radiofrequency ablation of hepatocellular carcinoma: a meta-analysis of randomized controlled trials.

Abdom Radiol (NY) 2021 Apr 18. Epub 2021 Apr 18.

Department of Radiology, University of Chicago, Chicago, IL, USA.

Purpose: Percutaneous radiofrequency ablation (RFA) and microwave ablation (MWA) are well-validated interventions for hepatocellular carcinoma (HCC). The purpose of this study was to compare their safety and efficacy through a meta-analysis of randomized controlled trials (RCT).

Methods: MEDLINE, Pubmed, and the Cochrane Library were queried up to September 2020 using the terms "microwave", "radiofrequency", "hepatocellular", and "randomized". Read More

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Efficacy of vitamin D supplementation on adult patients with non-alcoholic fatty liver disease: a single-center experience.

Gastroenterol Hepatol Bed Bench 2021 ;14(1):44-52

Internal Medicine Department, Faculty of Medicine, Zagazig University, Egypt.

Aim: The aim of this study was to determine the efficacy of a 6-month intramuscular vitamin D supplementation in improving the liver parameters in adult patients with non-alcoholic fatty liver disease (NAFLD).

Background: The association between vitamin D level and NAFLD has not been determined.

Methods: A single-blinded non-randomized controlled trial was conducted in 80 NAFLD patients assigned to receive a monthly single intramuscular dose of 200,000 IU cholecalciferol/vitamin D3 (n= 40), or placebo (n= 40) for six months. Read More

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January 2021

A randomized clinical study to examine the oral hygiene efficacy of a novel herbal toothpaste with zinc over a 6 month period.

Int J Dent Hyg 2021 Apr 18. Epub 2021 Apr 18.

Department of Periodontics, JSS Dental College and Hospital, JSS Academy of Higher Education & Research (Deemed to be University), Mysuru, 570 015, India.

Objectives: This clinical investigation examined the effects of brushing with a test toothpaste containing natural ingredients i.e., Clove (Syzgium Aromaticum), Aloe Vera (Aloe Barbadensis), Amla (Emblica Officinalis), Neem (Azadirachta Indica), Tulsi (Ocimum Basillicum) and Honey (from Apis Mellifera) along with zinc salts and fluoride in comparison to a dentifrice formulated with fluoride alone on dental plaque and gingivitis over a 6-month period. Read More

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Implementation of a workplace physical activity intervention in child care: process evaluation results from the Care2BWell trial.

Transl Behav Med 2021 Apr 17. Epub 2021 Apr 17.

Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Care2BWell was designed to evaluate the efficacy of Healthy Lifestyles (HL), a worksite health promotion intervention to increase child care workers' physical activity. The purpose of this study was to use process evaluation to describe the implementation of HL and determine if different levels of implementation are associated with changes in workers' physical activity. Data were collected from 250 workers randomized to HL, a 6 month, multilevel intervention that included an educational workshop followed by three 8 week campaigns that included self-monitoring and feedback, raffle incentive, social support, and center director coaching. Read More

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Relationships Between Dietary Intake and Weight-Related Experiential Avoidance Following Behavioral Weight-Loss Treatment.

Int J Behav Med 2021 Apr 17. Epub 2021 Apr 17.

VA San Diego Healthcare System, San Diego, USA.

Background: Interventions targeting weight-related experiential avoidance (EA) and disinhibited eating (DE) may also improve diet quality. Participants with overweight/obesity and DE who recently completed a behavioral weight-loss program were randomized to receive acceptance and commitment therapy or continued behavioral weight-loss treatment. In this secondary analysis, we explored (1) change in diet quality from baseline to 6-month follow-up (FU) and (2) whether weight-related EA at baseline and (3) change in weight-related EA during treatment were related to change in diet quality from baseline to FU. Read More

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Therapy adjustments in people with type 1 diabetes with impaired hypoglycemia awareness on multiple daily injections using real-time continuous glucose monitoring: a mechanistic analysis of the HypoDE study.

BMJ Open Diabetes Res Care 2021 Apr;9(1)

Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.

Introduction: Studies have shown beneficial effects of real-time continuous glucose monitoring (rtCGM) usage on clinical outcomes. The objective of this analysis was to identify which therapy adjustments were made by people with type 1 diabetes with impaired hypoglycemia awareness during rtCGM usage enabling reductions in the number of low glucose events observed in the HypoDE (Hypoglycemia in Deutschland) study.

Research Design And Methods: In the multicenter randomized controlled trial in people with type 1 diabetes on multiple daily injections with impaired hypoglycemia awareness, participants recorded their diabetes therapy in 7-day logbooks at baseline and at 6-month follow-up. Read More

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Loving-Kindness Meditation vs Cognitive Processing Therapy for Posttraumatic Stress Disorder Among Veterans: A Randomized Clinical Trial.

JAMA Netw Open 2021 Apr 1;4(4):e216604. Epub 2021 Apr 1.

Center of Excellence in Substance Addiction Treatment and Education, VA Puget Sound Health Care System, Seattle, Washington.

Importance: Additional options are needed for treatment of posttraumatic stress disorder (PTSD) among veterans.

Objective: To determine whether group loving-kindness meditation is noninferior to group cognitive processing therapy for treatment of PTSD.

Design, Setting, And Participants: This randomized clinical noninferiority trial assessed PTSD and depression at baseline, posttreatment, and 3- and 6-month follow-up. Read More

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Feasibility and Preliminary Efficacy of a Community-Based Addiction Rehabilitation Electronic System in Substance Use Disorder: Pilot Randomized Controlled Trial.

JMIR Mhealth Uhealth 2021 Apr 16;9(4):e21087. Epub 2021 Apr 16.

Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Background: Drug use disorder has high potential for relapse and imposes an enormous burden on public health in China. Since the promulgation of the Anti-drug law in 2008, community-based rehabilitation has become the primary approach to treat drug addiction. However, multiple problems occurred in the implementation process, leading to a low detoxification rate in the community. Read More

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A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study).

Trials 2021 Apr 15;22(1):284. Epub 2021 Apr 15.

University Department of Psychiatry, Centre d'Excellence Thérapeutique- Institut de Psychiatrie, Centre Hospitalier du Rouvray, Sotteville-lès-Rouen, France.

Background: Although clozapine is the most effective antipsychotic drug for treatment-resistant schizophrenia, it leads to a poor or partial response in 40 to 70% of patients. Augmentation of clozapine with electroconvulsive therapy (ECT) is a highly effective and relatively safe treatment for these clozapine-resistant patients. However, parameters are not yet well specified, such as the optimal number of sessions, their frequency, and the relevance of maintenance ECT. Read More

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A Tale of Two Centrifugal Flow Ventricular Assist Devices as Bridge to Heart Transplant.

Ann Thorac Surg 2021 Apr 12. Epub 2021 Apr 12.

Department of Cardiovascular and Thoracic Surgery, University of Louisville School of Medicine, Louisville, KY. Electronic address:

Background: Use of continuous flow left ventricular assist devices (CFVAD) has previously increased over the years as bridge to transplant (BTT). The Heartware HVAD and HeartMate III (HM3) are currently approved centrifugal flow devices used for BTT. We sought to evaluate outcomes of the patients listed and transplanted after receiving these two devices. Read More

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A pilot study comparing daily teriparatide with monthly cycles of teriparatide and raloxifene.

Arch Osteoporos 2021 04 15;16(1):70. Epub 2021 Apr 15.

Osteoporosis Clinical Research Program, University of Wisconsin-Madison, 2870 University Ave, Suite 100, Madison, WI, 53705, USA.

This 6-month pilot study in osteoporotic postmenopausal women evaluated cyclic TPD/RLX compared to daily subcutaneous TPD with the concept of optimizing bone formation. Compared to daily subcutaneous TPD, cyclic therapy showed comparable increase in spine BMD and favorable effects on total proximal femur BMD and cortical thickness.

Purpose: There is no cure for osteoporosis; better medications or different approaches with current agents are needed. Read More

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Antipsychotic treatment and risk of discontinuation and hospitalization in first-episode schizophrenia: a nationwide population-based study.

Psychol Med 2021 Apr 15:1-8. Epub 2021 Apr 15.

Department of Psychiatry, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.

Background: Current evidence on antipsychotic treatment and risk of psychiatric hospitalization in first-episode schizophrenia (FES) is largely based on the findings from randomized clinical trials (RCTs). However, the generalization of the findings to real-world patients is limited due to inherent caveats of the RCT. We aimed to investigate the treatment discontinuation and risk of psychiatric hospitalization using a nationwide population database. Read More

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Changes in Body Composition and Cardiometabolic Health After Detraining in Older Men with Osteosarcopenia: 6-Month Follow-Up of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST) Study.

Clin Interv Aging 2021 6;16:571-582. Epub 2021 Apr 6.

Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, 91053, Germany.

Purpose: Temporary cessation of exercise but maintenance of habitual physical activity might be a frequent situation in older people's lives. Particularly the COVID-19 induced lockdown of exercise training facilities with individual outdoor activities still being allowed might be a blueprint for this potentially harmful scenario. Thus, the aim of the present study was to determine the effects of 6 months of detraining after 18 months of high-intensity resistance exercise (HIT-RT) on body composition and cardiometabolic outcomes in predominately obese older men with osteosarcopenia. Read More

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Ready-to-Use Micronized Human Acellular Dermal Matrix to Accelerate Wound Healing in Diabetic Foot Ulcers: A Prospective Randomized Pilot Study.

Adv Skin Wound Care 2021 May;34(5):1-6

At the Ajou University School of Medicine, Suwon, Republic of Korea, Hyung Min Hahn, MD, is Assistant Professor; Dong Hwan Lee, MD, is a Resident; Il Jae Lee, MD, PhD, is Associate Professor, Department of Plastic and Reconstructive Surgery. Acknowledgments: The authors thank Editage (www.editage.co.kr) for English language editing. This research was supported by a Korea Health Industry Development Institute grant to Ajou University Medical Center. The authors have disclosed no other financial relationships related to this article. Submitted May 28, 2020; accepted in revised form September 3, 2020.

Objective: To examine and report clinical outcomes of a ready-to-use micronized dermal matrix for diabetic foot ulcers (DFUs) and compare it to treatment with conventional negative-pressure wound therapy (NPWT) only.

Methods: The researchers randomly allocated 30 DFUs Wagner grade 2 or higher from 30 adult patients into two groups. The control group (n = 15) was treated with conventional NPWT, and the experimental group (n = 15) was treated with micronized dermal matrix and NPWT. Read More

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Mindfulness and acceptance-based behavioral treatment for bulimia-spectrum disorders: A pilot feasibility randomized trial.

Int J Eat Disord 2021 Apr 14. Epub 2021 Apr 14.

Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania, USA.

Objective: Although existing research supports the efficacy of mindfulness- and acceptance-based treatments (MABTs) for eating disorders (EDs), few studies have directly compared outcomes from MABTs to standard CBT.

Method: Participants (N = 44), treatment-seeking adults with bulimia-spectrum EDs, were screened for eligibility, consented, and randomized to receive 20 sessions of outpatient, individual CBT or MABT treatment. Treatment outcomes (binge eating and compensatory behavior episodes, global ED severity, depressive symptoms, quality of life, emotional awareness/clarity, distress tolerance, values-based decision-making, and emotion modulation) were measured at pre-treatment, post-treatment, and 6-month follow up. Read More

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Effect of peer support on improving self-management ability in peritoneal dialysis patients-a randomized controlled trial.

Ann Palliat Med 2021 Mar;10(3):3028-3038

Nursing Department of Wuxi People's Hospital, Wuxi, China.

Background: Peritoneal dialysis (PD) is an ideal method for the treatment of chronic kidney disease. Its survival rate and quality of life depend on the quality of dialysis. The quality of dialysis depends on the compliance of patients with drugs and dialysis treatment, the choice of diet, the detection of complications and the monitoring and management of the disease. Read More

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A weight-loss Mediterranean diet/lifestyle intervention ameliorates inflammation and oxidative stress in patients with obstructive sleep apnea: results of the "MIMOSA" randomized clinical trial.

Eur J Nutr 2021 Apr 10. Epub 2021 Apr 10.

Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University, 70 Eleftheriou Venizelou Str., 17671, Athens, Greece.

Purpose: Inflammation and oxidative stress are implicated in obstructive sleep apnea (OSA) pathophysiology. We aimed at exploring whether the combination of a weight-loss Mediterranean diet/lifestyle intervention with OSA standard care, i.e. Read More

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Effect of Aerobic or Resistance Exercise, or Both, on Intermuscular and Visceral Fat and Physical and Metabolic Function in Older Adults with Obesity While Dieting.

J Gerontol A Biol Sci Med Sci 2021 Apr 11. Epub 2021 Apr 11.

Division of Endocrinology, Diabetes, and Metabolism, Baylor College of Medicine, Houston, Texas.

Background: Obesity exacerbates age-related effects on body composition, physical and metabolic function. Which exercise mode is most effective in mitigating these deleterious changes in dieting obese older adults is unknown.

Methods: In a randomized controlled trial, we performed a head-to-head comparison of aerobic (AEX), resistance (REX), or combination (COMB) exercise during matched weight loss in 160 obese older adults. Read More

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A review of flash glucose monitoring in type 2 diabetes.

Diabetol Metab Syndr 2021 Apr 9;13(1):42. Epub 2021 Apr 9.

Abbott Diabetes Care, Sao Paulo, Brazil.

Background: Continuous glucose monitoring systems are increasingly being adopted as an alternative to self-monitoring of blood glucose (SMBG) by persons with diabetes mellitus receiving insulin therapy.

Main Body: The FreeStyle Libre flash glucose monitoring system (Abbott Diabetes Care, Witney, United Kingdom) consists of a factory-calibrated sensor worn on the back of the arm which measures glucose levels in the interstitial fluid every minute and stores the reading automatically every 15 min. Swiping the reader device over the sensor retrieves stored data and displays current interstitial glucose levels, a glucose trend arrow, and a graph of glucose readings over the preceding 8 h. Read More

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Do Relaxation Exercises Decrease Pain After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial.

Clin Orthop Relat Res 2021 May;479(5):870-884

D. G. Weekes, R. E. Campbell, E. D. Wicks, C. J. Hadley, Z. S. Chaudhry, A. H. Carter, M. D. Pepe, B. S. Tucker, K. B. Freedman, F. P. Tjoumakaris, The Rothman Orthopaedic Institute, Thomas Jefferson University, Philadelphia, PA, USA.

Background: Pain after rotator cuff repair is commonly managed with opioid medications; however, these medications are associated with serious adverse effects. Relaxation exercises represent a potential nonpharmacologic method of pain management that can be easily implemented without substantial adverse effects; however, the effects of relaxation exercises have not been studied in a practical, reproducible protocol after arthroscopic rotator cuff repair.

Questions/purposes: (1) Does performing relaxation exercises after arthroscopic rotator cuff repair (ARCR) decrease pain compared with standard pain management medication? (2) Does performing relaxation exercises after ARCR decrease opioid consumption? (3) What proportion of patients who used the relaxation techniques believed they decreased their pain level, and what proportion continued using these techniques at 2 weeks? (4) Does performing relaxation exercises after ARCR affect shoulder function?

Methods: During the study period, 563 patients were eligible for inclusion; however, only 146 were enrolled, randomized, and postoperatively followed (relaxation group: 74, control group: 72); 68% (384 of 563) of patients were not contacted due to patient and research staff availability. Read More

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Usability and Acceptability of a Mobile App for the Self-Management of Alcohol Misuse Among Veterans (Step Away): Pilot Cohort Study.

JMIR Mhealth Uhealth 2021 Apr 8;9(4):e25927. Epub 2021 Apr 8.

Center of Excellence in Substance Addiction Treatment and Education (CESATE), Veterans Affairs Puget Sound Health Care System, Seattle, WA, United States.

Background: Alcohol misuse is common among Operation Enduring Freedom and Operation Iraqi Freedom veterans, yet barriers limit treatment participation. Mobile apps hold promise as means to deliver alcohol interventions to veterans who prefer to remain anonymous, have little time for conventional treatments, or live too far away to attend treatment in person.

Objective: This pilot study evaluated the usability and acceptability of Step Away, a mobile app designed to reduce alcohol-related risks, and explored pre-post changes on alcohol use, psychological distress, and quality of life. Read More

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Frailty implications for exercise participation and outcomes in patients with heart failure.

J Am Geriatr Soc 2021 Apr 7. Epub 2021 Apr 7.

Physiotherapy Department, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.

Background/objectives: Frailty is common in people with heart failure (HF) and associated with poorer outcomes. The aim of this study was to describe the characteristics, exercise participation, and outcomes of frail and not-frail participants enrolled in a randomized trial of exercise training (ET) within a cardiac rehabilitation (CR) program.

Design: Secondary analysis of EJECTION-HF randomized trial (ACTRN12608000263392). Read More

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MEVITEM - A Phase I/II of vismodegib + temozolomide vs temozolomide in patients with recurrent/refractory medulloblastoma with Sonic Hedgehog pathway activation.

Neuro Oncol 2021 Apr 7. Epub 2021 Apr 7.

Clinical Research Platform (DRCI) of Centre Léon Bérard, Lyon, France.

Background: Vismodegib specifically inhibits Sonic Hedgehog (SHH). We report results of a Phase I/II evaluating vismodegib + temozolomide in immunohistochemically defined SHH recurrent/refractory adult medulloblastoma.

Methods: Temozolomide naïve patients were randomized 2:1 to receive vismodegib + temozolomide (Arm A) or temozolomide (Arm B). Read More

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Results of a Randomized Trial of Screening, Brief Intervention, and Referral to Treatment (SBIRT) to Reduce Alcohol Misuse Among Active-Duty Military Personnel.

J Stud Alcohol Drugs 2021 Mar;82(2):269-278

Naval Health Research Center, San Diego, California.

Objective: Rates of heavy alcohol use among active-duty military personnel in the United States are high and negatively affect individuals within the service branches. This study tested the effectiveness of a military-focused screening, brief intervention, and referral to treatment (SBIRT) intervention for reducing risky alcohol use among active-duty patients.

Method: We used a randomized, parallel, two-group design to test the effectiveness of the SBIRT intervention in a convenience sample of service members recruited from the emergency department of a military hospital. Read More

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Loss of benefits after cessation of exercise interventions in nursing home residents: randomized controlled trial follow-up.

Geriatr Nurs 2021 Apr 3;42(3):621-627. Epub 2021 Apr 3.

Department of Physiology, Faculty of Medicine and Nursing, University of the Basque Country (UPV/EHU), Barrio Sarriena s/n, E-48940 Leioa (Bizkaia), Spain.

Exercise interventions improve physical fitness, cognitive and affective function, and quality of life among nursing home residents. However, little is known regarding the consequences of cessation of activity, or detraining. We analyzed physical fitness, physical activity level, cognitive function, quality of life, and loneliness during a 6-month observational follow-up after a 6-month randomized controlled trial in which nursing home residents performed either routine activities (control group) or group-based exercise (intervention group). Read More

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