980,905 results match your criteria randomized control

Clinical predictors of poor 30-day headache outcomes after an emergency department visit for acute post-traumatic headache.

Am J Emerg Med 2021 Jun 9;49:158-162. Epub 2021 Jun 9.

Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, 111 East 210th Street, Bronx, NY 10467, USA. Electronic address:

Purpose: We investigated clinical risk factors that predict poor 30-day headache outcomes among patients evaluated in the emergency department (ED) for post-traumatic headache (PTH).

Methods: This was an analysis of data from a randomized, placebo-controlled study of IV metoclopramide + diphenhydramine for acute PTH. Patients were enrolled during an ED visit and received telephone follow-up with a structured questionnaire 30 days later. Read More

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Collision avoidance behaviours between older adult and young adult walkers.

Gait Posture 2021 Jun 9;88:210-215. Epub 2021 Jun 9.

Univ Rennes, Inria, CNRS, IRISA, M2S, France.

Background: Collision avoidance between two walkers requires a mutual adaptation based on visual information in order to be successful. Age-related changes to visuomotor processing, kinesthetic input, and intersegmental dynamics increases the risk of collision and falls in older adults. However, few studies examine behavioural strategies in older adults during collision avoidance tasks with another pedestrian. Read More

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Reductions in tobacco use in naltrexone, relative to buprenorphine-maintained individuals with opioid use disorder: Secondary analysis from the National Drug Abuse Treatment Clinical Trials Network.

J Subst Abuse Treat 2021 May 21;130:108489. Epub 2021 May 21.

Department of Psychiatry, NYU Grossman School of Medicine, One Park Avenue, New York, NY 10016, USA.

Background: Smoking prevalence in individuals with opioid use disorder (OUD) is over 80%. Research suggests that opioid use significantly increases smoking, which could account for the strikingly low smoking-cessation rates observed in both methadone- and buprenorphine-maintained patients, even with the use of first-line smoking-cessation interventions. If opioids present a barrier to smoking-cessation, then better smoking outcomes should be observed in OUD patients treated with extended-release naltrexone (XR-NTX, an opioid antagonist) compared to those receiving buprenorphine (BUP-NX, a partial opioid agonist). Read More

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Targeting women veteran's stress-induced drinking with cognitive reappraisal: Mechanisms and moderators of change.

J Subst Abuse Treat 2021 Apr 14;130:108408. Epub 2021 Apr 14.

VA Central Western Massachusetts, Division of Research and Education, 421 North Main Street, Leeds, MA 01053, United States of America; University of Massachusetts Medical School, Department of Psychiatry, 365 Plantation Street Biotech One, Worcester, MA 01605, United States of America.

Emotion dysregulation mediates the effects of stress on drinking among individuals with co-occurring emotional and alcohol use disorders (AUD). The current study examined the effects of cognitive reappraisal (CR), an adaptive emotion regulation strategy, on mechanisms that contribute to drinking (alcohol craving, inhibitory control) among 50 women veterans. In session one, participants were randomized to one of two 50-min "microinterventions", either to learn a CR coping strategy or receive non-therapeutic psychoeducation control. Read More

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Extended-release naltrexone for youth with opioid use disorder.

J Subst Abuse Treat 2021 Apr 15;130:108407. Epub 2021 Apr 15.

Friends Research Institute, 1040 Park Avenue, Suite, 103 Baltimore, MD, USA. Electronic address:

Background: Few published research studies have examined the effectiveness of extended-release naltrexone (XR-NTX) for the treatment of opioid use disorder (OUD) among adolescents and young adults.

Methods: This two-group randomized controlled trial recruited 288 youth, ages 15-21, with moderate/severe OUD from a residential addiction treatment program in Baltimore, Maryland. The study randomized the youth within the first week of treatment entry to receive either XR-NTX or treatment-as-usual (TAU; either buprenorphine maintenance treatment or treatment without OUD medication following medically managed withdrawal) prior to discharge, with continued treatment in the community for 6 months. Read More

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The immunomodulatory effects of topiramate on azoxymethane-induced colon carcinogenesis in rats: The role of the inflammatory cascade, vascular endothelial growth factor, AKT/mTOR/MAP kinase signaling and the apoptotic markers.

Int Immunopharmacol 2021 Jun 9;98:107830. Epub 2021 Jun 9.

Department of Pharmacology and Toxicology, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi Arabia.

Background: Colon cancer is a malignant condition that affects the lower gastrointestinal tract and has unfavorable prognosis. Its mechanisms range from enhanced production of reactive oxygen species, inflammatory changes in the colon microenvironment and affection of the apoptotic pathways. Due to the high incidence of resistance of colon cancer to the traditional chemotherapeutic agents, a need for finding safe/effective agents that can attenuate the malignant changes had emerged. Read More

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Illness stage and predominant polarity in bipolar disorder: Correlation with burden of illness and moderation of treatment outcome.

J Psychiatr Res 2021 Jun 2;140:205-213. Epub 2021 Jun 2.

Dauten Family Center for Bipolar Treatment Innovation, Department of Psychiatry, Massachusetts General Hospital, 50 Staniford Street, Suite 580, Boston, MA, 02114, United States; Harvard Medical School, 25 Shattuck Street, Boston, MA, 02115, United States. Electronic address:

Bipolar disorder often follows a set progression best described in stages where advanced stages are associated with poorer outcomes. Bipolar disorder is also often characterized by a predominance of episode polarity, where some individuals experience more depressive episodes (termed predominant depressive polarity) while others experience more hypo/manic episodes (termed predominant hypo/manic polarity). We examined the associations between staging and predominant polarity with measures of illness burden and treatment outcome utilizing data from a six-month comparative effectiveness trial of lithium and quetiapine in bipolar disorder (Bipolar CHOICE). Read More

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Randomized trial of high-dose pyridoxine in combination with standard hormonal therapy in West syndrome.

Seizure 2021 May 29;91:75-80. Epub 2021 May 29.

Pediatric Neurology Unit, Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

Objective: To determine whether high-dose, oral pyridoxine in combination with standard adrenocorticotropic hormone (ACTH) therapy has superior effectiveness than ACTH therapy alone in increasing cessation of epileptic spasms for children with West syndrome.

Methods: This study was an open-label, randomized controlled trial with masked endpoint assessments. Eligible children with West syndrome, age ranged 3-18 months, were randomized into the intervention (n = 43) and the standard arm (n = 37) of therapy. Read More

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The effect of Raphanus sativus L. seeds on regulation of intestinal motility in rats consuming a high-calorie diet.

Biomed Pharmacother 2021 Jun 9;140:111705. Epub 2021 Jun 9.

School of Basic Medical Science, Beijing University of Chinese Medicine, Beijing, PR China. Electronic address:

Purpose: The purpose of this study was to explore the effects of a short-term high-calorie diet and the regulation mechanism of Raphanus sativus L. seeds (RSL seeds) on the intestinal motility of young rats.

Methods: We fed 20 Specific Pathogen Free (SPF) 4-week-old male Sprague-Dawley (SD) rats special high-calorie diet for 3 days and then randomized them to a high-calorie diet group (HCG, 10 rats) and an RSL seeds treatment group (TG, 10 rats). Read More

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Application of a new serratus anterior plane block in modified radical mastectomy under ultrasound guidance: A prospective, randomized controlled trial.

J Clin Anesth 2021 Jun 9;74:110377. Epub 2021 Jun 9.

Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China. Electronic address:

Study Objectives: Post-operative pain is a significant concern following modified radical mastectomy in breast cancer patients. The serratus anterior plane block has recently been described as an effective technique for post-operative analgesia of modified radical mastectomy. The purpose of this study was to evaluate the analgesic efficacy and safety of a new serratus anterior plane (SAP) block for post-operative pain of mastectomy. Read More

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The predictive value of clinical, radiographic, echocardiographic variables and cardiac biomarkers for assessing risk of the onset of heart failure or cardiac death in dogs with preclinical myxomatous mitral valve disease enrolled in the DELAY study.

J Vet Cardiol 2021 May 16;36:77-88. Epub 2021 May 16.

Clinica Veterinaria Gran Sasso, Milan, Italy.

Objectives: To identify the predictive value on time to onset of heart failure (HF) or cardiac death of clinical, radiographic, and echocardiographic variables, as well as cardiac biomarkers N-terminal pro brain natriuretic peptide (NT-proBNP) and cardiac troponin I in dogs with preclinical myxomatous mitral valve disease (MMVD).

Animals: One hundred sixty-eight dogs with preclinical MMVD and left atrium to aortic root ratio ≥1.6 (LA:Ao) and normalized left ventricular end-diastolic diameter ≥1. Read More

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Effect of thiamine supplementation in critically ill patients: A systematic review and meta-analysis.

J Crit Care 2021 Jun 4;65:104-115. Epub 2021 Jun 4.

Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, VCU School of Medicine, Richmond, VA, USA. Electronic address:

Introduction: Several studies have previously shown the benefit of thiamine supplementation in critically ill patients. In order to fully appraise the available data, we performed a meta-analysis of 18 published studies.

Methods: A thorough systematic search was conducted. Read More

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Improving Vaccination for Young Children (IVY): A Stepped-Wedge Cluster Randomized Trial.

Acad Pediatr 2021 Jun 9. Epub 2021 Jun 9.

Vanderbilt University Medical Center, Department of Pediatrics, 1211 Medical Center Dr, Nashville, TN 37232, Nashville, Tennessee, United States. Electronic address:

Background: High childhood vaccination rates are critical for public health. We hypothesized that implementation of a vaccine education and quality improvement (QI) program, Improving Vaccinations for Young Children (IVY), would improve childhood vaccine rates.

Methods: Eight pediatric practices (3 academic-based, 5 community-based) were randomized to implement IVY within a stepped-wedge cluster randomized trial (SWCRT) in middle Tennessee. Read More

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J Stomatol Oral Maxillofac Surg 2021 Jun 9. Epub 2021 Jun 9.

Professor, Chief of the Service de Stomatologie et de Chirurgie Maxillo-faciale de la Pitié Salpétrière (France).

Objective: This pilot randomized crossover study evaluated the outcomes of two custom-made mandibular retention devices (MRDs), a computer-aided design (CAD)/computer-aided manufacturing (CAM) device (Narval CC™) and a non-CAD/CAM device (Narval™), on oropharyngeal airway volume in patients with obstructive sleep apnoea (OSA).

Methods: 12 OSA patients were recruited from an University Hospital for MRD therapy with either CAD/CAM or non-CAD/CAM first. A cone-beam computed tomography evaluation (CBCT) and polysomnography assessment was performed during baseline assessment and at the end of each study period. Read More

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Menstrual Phase Does Not Influence Ventilatory Responses to Group III/IV Afferent Signaling in Eumenorrheic Young Females.

Respir Physiol Neurobiol 2021 Jun 9:103712. Epub 2021 Jun 9.

Division of Physical Therapy, University of Minnesota, 420 Delaware St. SE, Minneapolis, MN, 55455, United States; Division of Rehabilitation Science, University of Minnesota, 420 Delaware St. SE, Minneapolis, MN, 55455, United States.

Estrogen can reduce sympathetic activity, but its effects on minute ventilation (V) with group III/IV afferent activation remain unclear. This study examined the influence of estrogen on V during lower-extremity exercise with group III/IV activation. Females completed two identical visits in follicular and ovulatory menstrual phases. Read More

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Rationale and protocol for a cluster randomized, cross-over trial of recruitment methods of rural children in primary care clinics: A feasibility study of a pediatric weight control trial in the IDeA States Pediatric Clinical Trials Network.

Contemp Clin Trials 2021 Jun 9:106476. Epub 2021 Jun 9.

Center for Children's Healthy Lifestyles & Nutrition, 610 E 22(nd) Street, Kansas City, MO 64109, United States.

A significant percentage of clinical trials fail due to poor recruitment. Despite this, few studies exist to evaluate clinical trial recruitment strategies using a randomized approach in any population, and none exist to test recruitment strategies for trials involving children or rural populations. For clinical trials focused on weight control, evaluating retention and dose are extremely important, as poor retention can lead to biased samples and existing research shows that dose (i. Read More

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Tai Chi for health and well-being: A bibliometric analysis of published clinical studies between 2010 and 2020.

Complement Ther Med 2021 Jun 9:102748. Epub 2021 Jun 9.

NICM Health Research Institute, Western Sydney University, Penrith, NSW 2751, Australia.

The objective of this bibliometric review was to identify the volume, breadth, and characteristics of clinical studies evaluating Tai Chi published between January 2010 and January 2020. Five English and four Chinese language databases were searched. Following independent screening, 1018 eligible publications representing 987 studies were identified, which was a three-fold increase from the previous decade. Read More

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TikTok browsing for anxiety relief in the preoperative period: a randomized clinical trial.

Complement Ther Med 2021 Jun 9:102749. Epub 2021 Jun 9.

Department of Anesthesiology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. Electronic address:

Objective: The purpose of this study was to determine the effect of browsing TikTok for 20 minutes on patients' preoperative anxiety.

Method: A randomized controlled trial was conducted at the Department of Anesthesiology of The First Affiliated Hospital, Zhejiang University School of Medicine from January 2021 to March 2021. The 80 patients were randomly divided into two groups. Read More

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The Impact of Gender on Researchers' Assessment: A Randomized Controlled Trial.

J Clin Epidemiol 2021 Jun 9. Epub 2021 Jun 9.

Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital - General Campus, 501 Smyth Rd, Ottawa, Canada. Electronic address:

Objectives: This randomized controlled trial aimed to test whether women or men would be preferred with identical curriculum vitae (CV); and the impact of the career stage in the evaluators' choice.

Study Design And Setting: A simulated post-doctoral process was carried forward to be assessed for judgment. Level 1 and 2 Brazilian fellow researchers in the field of Dentistry were invited to act as external reviewers in a post-doctoral process and were randomly assigned to receive a CV from a woman or a man. Read More

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Arteriovenous Access Type and Risk of Mortality, Hospitalization, and Sepsis Among Elderly Hemodialysis Patients: A Target Trial Emulation Approach.

Am J Kidney Dis 2021 Jun 9. Epub 2021 Jun 9.

Department of Population Health Sciences, University of Wisconsin School of Medicine and Public Health; Madison, Wisconsin; Department of Medicine, University of Wisconsin School of Medicine and Public Health; Madison, Wisconsin. Electronic address:

Rationale & Objective: Evidence is mixed regarding the optimal choice of the first permanent vascular access for elderly patients on hemodialysis (HD). Lacking data from randomized controlled trials (RCT), we used a target trial emulation approach to compare arteriovenous fistula (AVF) versus arteriovenous graft (AVG) placement among elderly patients on HD.

Study Design: Retrospective cohort study. Read More

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Delgocitinib ointment in pediatric patients with atopic dermatitis: a phase 3, randomized, double-blind, vehicle-controlled study and a subsequent open-label, long-term study.

J Am Acad Dermatol 2021 Jun 9. Epub 2021 Jun 9.

Pharmaceutical Division, Japan Tobacco Inc., Tokyo, Japan.

Background: Delgocitinib 0.5% ointment, a topical JAK inhibitor, has been approved for adult patients with atopic dermatitis (AD) in Japan.

Objective: To evaluate the efficacy and safety of delgocitinib ointment in pediatric patients with AD. Read More

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Ultrasound-guided erector spinae plane block for open inguinal hernia repair: a randomized controlled trial.

Braz J Anesthesiol 2021 Jun 9. Epub 2021 Jun 9.

SIANEST/Hospital Florianópolis, Unidade de Anestesiologia, Florianópolis, SC, Brazil; Universidade do Sul de Santa Catarina (UNISUL), Florianópolis, SC, Brazil; TSA, Sociedade Brasileira de Anestesiologia, Brazil.

Introduction And Objectives: Inguinal hernia repair is associated with significant postoperative pain. We assessed the analgesia efficacy of unilateral Erector Spinae Plane block (ESP) performed under ultrasound guidance in patients submitted to open unilateral inguinal hernia repair, comparing ESP to spinal anesthesia administered with or without opioid.

Method: Forty-five patients with ages ranging from 27 to 83 years were randomly allocated into three groups: control group receiving spinal anesthesia (n = 14), ESP group receiving ESP block combined with spinal anesthesia (n = 16), and spinal morphine group receiving spinal anesthesia with morphine 1 mcg. Read More

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Effect of vitamin D supplementation on lung function in children with asthma and low vitamin D levels.

J Allergy Clin Immunol 2021 Jun 9. Epub 2021 Jun 9.

Division of Pulmonary Medicine, Department of Pediatrics, UPMC Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address:

Background: Observational studies have yielded inconsistent findings for the relation between vitamin D level and total IgE or allergic sensitization.

Objective: To determine whether vitamin D supplementation reduces levels of total IgE and IgE to each of two common indoor allergens in children with asthma and low vitamin D levels.

Methods: Total IgE, IgE to Dermatophagoides pteronyssinus (Der p), and IgE to Blattella germanica (Bla g) were measured at the randomization and exit visits for 174 participants in the Vitamin D Kids Asthma study (VDKA), a multicenter, double-blind, randomized placebo-controlled trial of vitamin D supplementation (4,000 IU/day) to prevent severe exacerbations in children with persistent asthma and vitamin D levels <30 ng/ml. Read More

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Peripherally active dextromethorphan derivatives lower blood glucose levels by targeting pancreatic islets.

Cell Chem Biol 2021 Jun 2. Epub 2021 Jun 2.

Institute for Vascular and Islet Cell Biology, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at Heinrich Heine University, 40225 Düsseldorf, Germany; Institute of Metabolic Physiology, Heinrich Heine University, 40225 Düsseldorf, Germany; Center of Competence for Innovative Diabetes Therapy (KomIT), German Diabetes Center (DDZ), 40225 Düsseldorf, Germany; German Center for Diabetes Research (DZD e.V.), Helmholtz Zentrum München, 85764 Neuherberg, Germany. Electronic address:

Dextromethorphan (DXM) acts as cough suppressant via its central action. Cell-protective effects of this drug have been reported in peripheral tissues, making DXM potentially useful for treatment of several common human diseases, such as type 2 diabetes mellitus (T2DM). Pancreatic islets are among the peripheral tissues that positively respond to DXM, and anti-diabetic effects of DXM were observed in two placebo-controlled, randomized clinical trials in humans with T2DM. Read More

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First-in-Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Pirepemat, a Cortical Enhancer, in Healthy Volunteers.

Clin Pharmacol Drug Dev 2021 Jun 12. Epub 2021 Jun 12.

Integrative Research Laboratories Sweden AB, Gothenburg, Sweden.

Pirepemat (IRL752) is a cortical enhancer being developed for the prevention of falls in patients with Parkinson disease. This first-in-human, randomized, double-blind, placebo-controlled phase 1 study evaluated safety, tolerability, and pharmacokinetics (PK) of pirepemat administered as oral single ascending doses (10, 35, 75, 175, 350 mg) and multiple ascending doses (100 and 250 mg 3 times daily) for 7 days to healthy male volunteers. Twenty and 24 subjects were randomly assigned in the single ascending dose and multiple ascending doses parts of the study, respectively. Read More

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Single-Dose Pharmacokinetics and Tolerability of the Oral Epidermal Growth Factor Receptor Inhibitor Mobocertinib (TAK-788) in Healthy Volunteers: Low-Fat Meal Effect and Relative Bioavailability of 2 Capsule Products.

Clin Pharmacol Drug Dev 2021 Jun 12. Epub 2021 Jun 12.

Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

Mobocertinib (TAK-788) is a tyrosine kinase inhibitor under investigation for treatment of non-small cell lung cancer with activating EGFR exon 20 insertions. This study examined the safety; tolerability; pharmacokinetics (PK), including food effects; and bioavailability of mobocertinib in healthy volunteers. In part 1, fasted volunteers were randomized to placebo or mobocertinib in single-ascending-dose cohorts (20-160 mg). Read More

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Efficacy of bone-substitute materials use in immediate dental implant placement: A systematic review and meta-analysis.

Clin Implant Dent Relat Res 2021 Jun 12. Epub 2021 Jun 12.

Cochrane Netherlands and Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.

Objective: To assess the efficacy of using a bone substitute material (BSM) in the fixture-socket gap in patients undergoing tooth extraction and immediate implant placement.

Materials And Methods: MEDLINE, EMBASE, and CENTRAL databases were searched for randomized controlled trials (RCTs). RCTs were screened for eligibility, and data were extracted by two authors independently. Read More

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Defining the rate of, and factors influencing, radiographic progression of osteoarthritis of the canine hip joint.

Vet Rec 2021 Jun 12:e516. Epub 2021 Jun 12.

Translational Research in Pain (TRiP), Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina, USA.

Background: This study aimed to define the rate of progression of radiographic osteoarthritis (OA) of the canine hip joint and to describe factors affecting this progression.

Methods: Dogs that underwent unilateral total hip replacement (THR) were reviewed for the evaluation of radiographic appearance of the non-operated hip joint over time. Standard extended ventrodorsal hip radiographs were taken preoperatively and postoperatively. Read More

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