165,543 results match your criteria placebo intervention

A multiple-strain probiotic product provides a better enzymatic antioxidant response in individuals with constipation in a double-blind randomized controlled trial.

Nutrition 2021 Mar 4;89:111225. Epub 2021 Mar 4.

Department of Nutrition, Faculty of Health Sciences, Campus Universitário Darcy Ribeiro, Universidade de Brasília, Brasília, Distrito Federal, Brazil.

Objectives: Probiotics may have beneficial effects on intestinal dysbiosis. However, the effects of probiotics on redox and inflammatory responses in intestinal constipation remain unknown. The aim of this study was to investigate the effect of a multiple-strain probiotic on the redox and inflammatory responses in individuals with intestinal constipation. Read More

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Disease modifying therapies in relapsing-remitting multiple sclerosis: A systematic review and network meta-analysis.

Autoimmun Rev 2021 Apr 17:102826. Epub 2021 Apr 17.

Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China. Electronic address:

Objective: To compare the efficacy and compliance of up-to-date disease modifying therapies (DMTs) in patients with remitting-relapsing MS (RRMS).

Methods: We searched PubMed, EMBASE and Cochrane Library for eligible studies. Annualized relapse rate, discontinuation due to adverse events (AEs) were assessed as primary outcomes. Read More

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Long-term Tolerability and Efficacy of Golimumab in Active Non-Radiographic Axial Spondyloarthritis: Results From Open-Label Extension.

Rheumatology (Oxford) 2021 Apr 20. Epub 2021 Apr 20.

Department of Gastroenterology, Infectiology and Rheumatology, University Clinic Benjamin Franklin, Berlin, Germany.

Objectives: We report the open-label extension (OLE) of the GO-AHEAD study evaluating the long-term efficacy and safety of golimumab (GLM) in patients with non-radiographic axial spondyloarthritis (nr-axSpA).

Methods: Patients (both GLM- and placebo [PBO]-treated in the double-blind phase) received GLM 50 mg every 4 weeks during the OLE (36-week treatment; additional 8-week safety follow-up; GLM/GLM and PBO/GLM groups). All patients who entered and received ≥1 dose of study treatment in the OLE were included in the efficacy and safety analyses. Read More

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Efficacy and safety of IL-17 inhibitors for patients with psoriatic arthritis: a systematic review and meta-analysis.

Eur Rev Med Pharmacol Sci 2021 Apr;25(7):2958-2970

Dermatology Department, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, People's Republic of China.

Objective: The efficacy and safety of IL-17 inhibitors for patients with Psoriatic arthritis (PsA) is still a controversial issue.

Materials And Methods: We systematically searched MEDLINE, EMBASE and Cochrane for randomized controlled trials that compared IL-17 inhibitors with placebo or TNF inhibitor adalimumab in patients with PsA.

Results: Eleven studies with 5327 patients were included in the meta-analysis. Read More

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The impact of L-citrulline supplementation on glucose homeostasis, lipid profile, and some inflammatory factors in overweight and obese patients with type 2 diabetes: A double-blind randomized placebo-controlled trial.

Phytother Res 2021 Apr 20. Epub 2021 Apr 20.

Nutrition Research Center, Department of Biochemistry and Diet Therapy, School of Nutrition & Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.

This study investigated the impact of L-citrulline on glucose homeostasis, lipid profile, and inflammatory factors in overweight and obese patients with type 2 diabetes (T2D). In total, 54 participants with T2D were assigned to L-citrulline (3 g/day L-citrulline) or placebo groups and tested for 8 weeks. Serum levels of insulin, fasting glucose, hemoglobin A1c (HbA1c), lipid profile, tumor necrosis factor-α (TNF-α), high-sensitivity C-reactive protein (hs-CRP), and L-citrulline were measured pre- and post-intervention. Read More

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No interactive effect of lumbar epidural blockade and target-controlled infusion of propofol on mean arterial pressure, cardiac output and bispectral index: A randomised controlled and pharmacodynamic modelling study.

Eur J Anaesthesiol 2021 Apr 14. Epub 2021 Apr 14.

From the Department of Anaesthesiology, Leiden University Medical Centre (LUMC), Leiden, The Netherlands (ES, EO, AD, JV).

Background: It is generally accepted that a neuraxial blockade strengthens the sedative effects of propofol. Deafferentation caused by neuraxial blockade is thought to play a key role.

Objectives: The objective is to determine whether epidural blockade affects the bispectral index (BIS) of propofol and two other pharmacodynamic endpoints, mean arterial pressure (MAP) and cardiac output (CO). Read More

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Smartphone-controlled patch electro-acupuncture versus conventional pain relief during colonoscopy: a randomized controlled trial.

ANZ J Surg 2021 Apr 19. Epub 2021 Apr 19.

Colorectal Unit, Department of Surgery, Pusat Perubatan Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.

Background: Smartphone-controlled patch electro-acupuncture (SCEA) is a novel device which gives the same analgesic effect as with conventional acupuncture. There are no published articles in the English literature on the use of this device as a primary mode of pain relief during colonoscopy. Primary aims of this study were to investigate the efficacy of SCEA as a substitute for pain relief during colonoscopy. Read More

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Corticosteroids in COVID-19 and non-COVID-19 ARDS: a systematic review and meta-analysis.

Intensive Care Med 2021 Apr 19. Epub 2021 Apr 19.

Department of Medicine, McMaster University, Hamilton, ON, Canada.

Purpose: Corticosteroids are now recommended for patients with severe COVID-19 including those with COVID-related ARDS. This has generated renewed interest regarding whether corticosteroids should be used in non-COVID ARDS as well. The objective of this study was to summarize all RCTs examining the use of corticosteroids in ARDS. Read More

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Ibuprofen taken before exercise blunts the IL-6 response in older adults but does not alter bone alkaline phosphatase or c-telopeptide.

Eur J Appl Physiol 2021 Apr 19. Epub 2021 Apr 19.

Division of Geriatric Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Mail Stop B179, 12631 E. 17th Avenue, Room 8111, Aurora, CO, 80045, USA.

Introduction: Non-steroidal anti-inflammatory drugs (NSAIDs) taken before exercise have been shown to impair bone formation. NSAIDs also suppress inflammatory cytokines, such as interleukin-6 (IL-6), that can have pro-resorptive effects. It is unclear how taking NSAIDs timed around exercise influences inflammatory and bone biomarkers following an acute exercise bout in older adults. Read More

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Polymorphisms in SLC44A1 are associated with cognitive improvement in children diagnosed with fetal alcohol spectrum disorder: an exploratory study of oral choline supplementation.

Am J Clin Nutr 2021 Apr 19. Epub 2021 Apr 19.

Department of Psychiatry and Behavioral Sciences, University of Minnesota Twin Cities, Minneapolis, MN, USA.

Background: The essential nutrient choline provides one-carbon units for metabolite synthesis and epigenetic regulation in tissues including brain. Dietary choline intake is often inadequate, and higher intakes are associated with improved cognitive function.

Objective: Choline supplements confer cognitive improvement for those diagnosed with fetal alcohol spectrum disorder (FASD), a common set of neurodevelopmental impairments; however, the effect sizes have been modest. Read More

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The Effect of Acupressure on Fasting Blood Glucose and Glycosylated Hemoglobin Levels in Diabetic Patients: A Randomized Controlled Trial.

Int J Community Based Nurs Midwifery 2021 Apr;9(2):152-158

Department of Medical Surgical Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.

Background: Diabetes is the most common endocrine disorder. Non-pharmacological methods can be used for treatment of these patients. The present study aimed to investigate the effect of acupressure point on fasting blood glucose and glycosylated levels of diabetic patients. Read More

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A randomised, double-blind, placebo-controlled, pilot trial of intravenous plasma purified alpha-1 antitrypsin for SARS-CoV-2-induced Acute Respiratory Distress Syndrome: a structured summary of a study protocol for a randomised, controlled trial.

Trials 2021 Apr 19;22(1):288. Epub 2021 Apr 19.

Royal College of Surgeons in Ireland, Dublin, Ireland.

Objectives: The primary objective is to demonstrate that, in patients with PCR-confirmed SARS-CoV-2 resulting in Acute Respiratory Distress Syndrome (ARDS), administration of 120mg/kg of body weight of intravenous Prolastin®(plasma-purified alpha-1 antitrypsin) reduces circulating plasma levels of interleukin-6 (IL-6). Secondary objectives are to determine the effects of intravenous Prolastin® on important clinical outcomes including the incidence of adverse events (AEs) and serious adverse events (SAEs).

Trial Design: Phase 2, randomised, double-blind, placebo-controlled, pilot trial. Read More

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Physical characterisation and stability study of formulated Chromolaena odorata gel.

Curr Drug Deliv 2021 Apr 18. Epub 2021 Apr 18.

Department of Pharmaceutics, Faculty of Pharmacy, Universiti Teknologi MARA, Cawangan Selangor, 42300 Puncak Alam, Selangor. Malaysia.

Aim: Formulating topical products for skin delivery has always been a challenge for pharmaceutical scientists to fulfil good formulation criteria. Despite the challenges, gel-based drug delivery offers some advantages such that it is non-invasive, painless, avoidance of the first-pass metabolism and has satisfactory patient compliance.

Objectives: In this study, Chromolaena odorata gel and quercetin gel (bioactive flavonoid compound) were successfully formulated and compared with placebo and conventional wound aid gel. Read More

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Safety and efficacy of ubrogepant in participants with major cardiovascular risk factors in two single-attack phase 3 randomized trials: ACHIEVE I and II.

Cephalalgia 2021 Apr 19:3331024211000311. Epub 2021 Apr 19.

AbbVie, Madison, NJ, USA.

Objective: To examine the safety and efficacy of ubrogepant for acute treatment of migraine across cardiovascular (CV) disease risk categories.

Methods: ACHIEVE I and II were multicenter, double-blind, single-attack, phase 3 trials in adults with migraine, with or without aura. Participants were randomized 1:1:1 to placebo or ubrogepant (50 or 100 mg in ACHIEVE I; 25 or 50 mg in ACHIEVE II), to treat one migraine attack of moderate or severe headache pain intensity. Read More

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Effect of SGLT2 Inhibitors on Stroke and Atrial Fibrillation in Diabetic Kidney Disease: Results From the CREDENCE Trial and Meta-Analysis.

Stroke 2021 Apr 20:STROKEAHA120031623. Epub 2021 Apr 20.

Westmead Applied Research Centre, University of Sydney, Sydney, Australia (R.I.L.).

Background And Purpose: Chronic kidney disease with reduced estimated glomerular filtration rate or elevated albuminuria increases risk for ischemic and hemorrhagic stroke. This study assessed the effects of sodium glucose cotransporter 2 inhibitors (SGLT2i) on stroke and atrial fibrillation/flutter (AF/AFL) from CREDENCE (Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation) and a meta-analysis of large cardiovascular outcome trials (CVOTs) of SGLT2i in type 2 diabetes mellitus.

Methods: CREDENCE randomized 4401 participants with type 2 diabetes mellitus and chronic kidney disease to canagliflozin or placebo. Read More

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Astegolimab (anti-ST2) efficacy and safety in adults with severe asthma: a randomized clinical trial.

J Allergy Clin Immunol 2021 Apr 16. Epub 2021 Apr 16.

Department of Respiratory Sciences, University of Leicester, Leicestershire, United Kingdom. Electronic address:

Background: The interleukin (IL)-33/ST2 pathway is linked with asthma susceptibility. Inhaled allergens, pollutants, and respiratory viruses, which trigger asthma exacerbations, induce release of IL-33, an epithelial-derived "alarmin." Astegolimab, a human IgG2 monoclonal antibody, selectively inhibits the IL-33 receptor, ST2. Read More

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What Are the Effects of Methylprednisolone Injection Into the Masseter and Gluteal Muscle on Pain, Rdema and Trismus After Impacted Lower Third Molar Surgery? A Randomized Clinical Trial.

J Oral Maxillofac Surg 2021 Mar 13. Epub 2021 Mar 13.

Dentistry Student, Mashhad University of Medical Science, Mashhad, Iran. Electronic address:

Purpose: Methylprednisolone is widely administered after impacted third molar surgery. This study compared the effect of methylprednisolone injection into the masseter and gluteal muscle on pain, edema, and trismus after impacted lower third molar surgery.

Methods: This was a single-blind placebo-controlled randomized clinical trial. Read More

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Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial.

Lancet Respir Med 2021 Apr 16. Epub 2021 Apr 16.

Department of ENT, Guy's Hospital, London, UK; St Thomas' Hospital, King's College London, London, UK.

Background: Chronic rhinosinusitis with nasal polyps affects approximately 2-4% of the general population, and long-term use of systemic corticosteroids is associated with adverse effects. The aim of this study was to assess the efficacy and safety of mepolizumab in adults with recurrent, refractory severe bilateral chronic rhinosinusitis with nasal polyps.

Methods: SYNAPSE was a randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done at 93 centres, mainly hospitals, in 11 countries. Read More

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The clinical applications of five-alpha reductase inhibitors.

Kevin R Loughlin

Can J Urol 2021 Apr;28(2):10584-10588

Harvard Medical School, Vascular Biology Laboratory, Boston Children's Hospital, Boston, Massachusetts, USA.

INTRODUCTION Five-alpha reductase (5-AR) deficiency was first identified by Imperato-McGinley and Walsh as the cause of pseudohermaphroditism in two separate studies. The discoveries led to the development of finasteride (inhibitor of type 2 isoenzyme of 5-AR) and dutasteride (inhibitor of type 1 and type 2 isoenzymes of 5-AR. Both drugs have been proven effective for the treatment of benign prostatic hyperplasia and improve voiding symptoms, reduce the risk of urinary retention and the need for prostate surgery. Read More

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Progestogens for preventing miscarriage: a network meta-analysis.

Cochrane Database Syst Rev 2021 Apr 19;4:CD013792. Epub 2021 Apr 19.

Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health Research, University of Birmingham, Birmingham, UK.

Background: Miscarriage, defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, is common with approximately 25% of women experiencing a miscarriage in their lifetime, and 15% to 20% of pregnancies ending in a miscarriage. Progesterone has an important role in maintaining a pregnancy, and supplementation with different progestogens in early pregnancy has been attempted to rescue a pregnancy in women with early pregnancy bleeding (threatened miscarriage), and to prevent miscarriages in asymptomatic women who have a history of three or more previous miscarriages (recurrent miscarriage).

Objectives: To estimate the relative effectiveness and safety profiles for the different progestogen treatments for threatened and recurrent miscarriage, and provide rankings of the available treatments according to their effectiveness, safety, and side-effect profile. Read More

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Impact of Letermovir Use for Cytomegalovirus Prophylaxis on Re-Hospitalization Following Allogeneic Hematopoietic Stem Cell Transplantation: An Analysis of a Phase III Randomized Clinical Trial.

Pharmacoecon Open 2021 Apr 19. Epub 2021 Apr 19.

Division of Infectious Diseases, City of Hope National Medical Center, 1500 East Duarte Road, Duarte, CA, 91010, USA.

Background: Allogeneic hematopoietic stem cell transplantation (HSCT) is associated with substantial healthcare resource use, particularly when recipients develop cytomegalovirus (CMV) infection. Letermovir reduced post-HSCT CMV infection risk compared with placebo in a previous phase III trial. This analysis evaluated letermovir's impact on re-hospitalization post-transplant. Read More

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Growth hormone directly favors hepatic ketogenesis in persons with prediabetes or type 2 diabetes mellitus treated with empagliflozin.

Endocrine 2021 Apr 19. Epub 2021 Apr 19.

Post-graduation Program of Health Sciences, Londrina State University, Londrina, Brazil.

Purpose: Sodium-glucose cotransporter 2 inhibitors increase glucagon secretion by pancreatic alpha cells and the susceptibility to ketoacidosis. On the other hand, growth hormone (GH) stimulates peripheral lipolysis and provides free fatty acids (FFA) for ketogenesis; however, it remains unresolved whether GH directly impacts hepatic ketogenesis. We aimed to investigate the role of physiologic GH levels in promoting ketogenesis in prediabetic or type 2 diabetic patients under empagliflozin treatment. Read More

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Long-term safety and efficacy of sarilumab over 5 years in patients with rheumatoid arthritis refractory to TNF inhibitors.

Rheumatology (Oxford) 2021 Apr 19. Epub 2021 Apr 19.

Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Berlin, Germany.

Objective: To evaluate long-term safety and efficacy of sarilumab over 5 years in patients with RA refractory to TNF inhibitors (TNFi).

Methods: Patients in the 24-week randomized controlled trial (RCT) TARGET (NCT01709578) whoreceived double-blind placebo or sarilumab 150 or 200 mg every 2 weeks (q2w), plus conventionalsynthetic DMARDs (csDMARDs), were eligible to receive open-label sarilumab 200 mg q2w pluscsDMARDs in the open-label extension (OLE), EXTEND (NCT01146652). OLE dose reduction to 150 mg q2w was permitted per investigators' judgement or protocol-mandated safety concerns. Read More

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A Randomized, Single-Blind, Crossover Study Evaluating the Impact of OnabotulinumtoxinA Treatment on Mood and Appearance During the COVID-19 Pandemic.

Aesthet Surg J 2021 Apr 19. Epub 2021 Apr 19.

Department of Otolaryngology, Head, and Neck Surgery, Division of Facial Plastic and Reconstructive Surgery, University of Illinois at Chicago, Chicago, IL.

Background: The emergence of Coronavirus disease of 2019 (COVID-19), quickly became one of the most severe disease outbreaks in modern history. This caused many aesthetic practices around the country to close temporarily and led to a unique time period to evaluate the impact neurotoxin has in the setting of an ongoing pandemic.

Objectives: To examine whether the administration of onabotulinumtoxinA (BOTOX Cosmetic, Allergan plc, Coolock, Ireland), in regular users, synergistically amplifies the elevation in mood/happiness, self-satisfaction with appearance and overall satisfaction, in the context of the ongoing pandemic. Read More

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Does supplementation with leucine-enriched protein alone and in combination with fish-oil-derived n-3 PUFA affect muscle mass, strength, physical performance, and muscle protein synthesis in well-nourished older adults? A randomized, double-blind, placebo-controlled trial.

Am J Clin Nutr 2021 Apr 19. Epub 2021 Apr 19.

School of Public Health, Physiotherapy and Sport Science, University College Dublin, Dublin, Ireland.

Background: Leucine-enriched protein (LEU-PRO) and long-chain (LC) n-3 (ω-3) PUFAs have each been proposed to improve muscle mass and function in older adults, whereas their combination may be more effective than either alone.

Objective: The impact of LEU-PRO supplementation alone and combined with LC n-3 PUFAs on appendicular lean mass, strength, physical performance and myofibrillar protein synthesis (MyoPS) was investigated in older adults at risk of sarcopenia.

Methods: This 24-wk, 3-arm parallel, randomized, double-blind, placebo-controlled trial was conducted in 107 men and women aged ≥65 y with low muscle mass and/or strength. Read More

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Efficacy of a probiotic supplement in patients with atopic dermatitis: a randomized, double-blind, placebo-controlled clinical trial.

Eur J Dermatol 2021 Apr 16. Epub 2021 Apr 16.

Complife Italia Srl, Via Guido Rossa 1, 20024 Garbagnate Milanese(Mi), Italy.

Background: Atopic dermatitis (AD) is a multifactorial long-standing inflammatory skin disease with a high incidence worldwide in both adults and children. According to the recognized correlation between skin and intestine-the so-called "gut-skin axis"-gut unbalances can affect skin by inducing systemic inflammation and triggering dermatological diseases such as AD.

Objectives: To evaluate the efficacy of a food supplement containing selected strains of probiotics in ameliorating AD symptoms and skin conditions in adult volunteers. Read More

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Non-specific effect of omega-3 fatty acid supplementation on autistic spectrum disorder: systematic review and meta-analysis.

Nutr Neurosci 2021 Apr 19:1-13. Epub 2021 Apr 19.

Institute of Collective Health, Federal University of Bahia, Salvador, Bahia.

Methods: We searched seven databases and found 13 eligible controlled trials that use omega-3 supplementation in children and adolescents with ASD. We collected details on study design, intervention time, supplement dosage, and the autism assessment scale. Meta-analyses and subgroup analysis were conducted according to the autism symptoms. Read More

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Variations in athletic performance with occlusal splint in track and field athletes: a randomized clinical trial.

J Sports Med Phys Fitness 2021 Apr 19. Epub 2021 Apr 19.

Department of Surgical Sciences, CIR Dental School, University of Turin, Turin, Italy.

Background: Several studies have been proposed with the aim to demonstrate correlations between the dento-mandibular apparatus and the skeletal muscle system of the human body even in regions distant from the oral cavity. However, a definite conclusion cannot be drawn. The aim of this paper is to demonstrate a possible correlation between dental occlusion and sport performances in track and field athletes. Read More

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The role of aripiprazole in improvement of penile erection in schizophrenia patients with erectile dysfunction.

Med Glas (Zenica) 2021 Aug 1;18(2). Epub 2021 Aug 1.

Department of Physiology, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.

Aim To provide evidence regarding the effectiveness of aripiprazole in improving penile erection with a therapeutic strategy of add-on or switching therapy in patients with schizophrenia. Methods. PubMed, Cochrane, Clinical Key, ProQuest, EBSCOhost, and ScienceDirect were searched for any design study that evaluated aripiprazole only or versus control (placebo or other antipsychotic) for erectile dysfunction in patients with schizophrenia. Read More

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A randomized, placebo-controlled trial of zinc supplementation during pregnancy for the prevention of stunting: analysis of maternal serum zinc, cord blood osteocalcin and neonatal birth length.

Med Glas (Zenica) 2021 Aug 1;18(2). Epub 2021 Aug 1.

Department of Paediatrics, School of Medicine, Universitas Padjadjaran, Bandung, Indonesia.

Aim To investigate the influence of zinc supplementation on pregnant women for the prevention of stunting through an analysis of maternal serum zinc, cord blood osteocalcin and neonatal birth length. Methods This study was conducted with pre-test/post-test control groups and double-blind randomization. Patients were pregnant mothers in second or third trimester and with their newborns who met the inclusion criteria. Read More

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