168,594 results match your criteria randomized double-blind


High-Speed Characterization of Vocal Fold Vibrations in Normally Cycling and Postmenopausal Women: Randomized Double-Blind Analyses.

J Speech Lang Hear Res 2021 May 10:1-20. Epub 2021 May 10.

Department of Speech, Language, and Hearing Sciences, Auburn University, AL.

Purpose The aim of this study was to examine the influence of menstrual cycle phases (follicular, ovulatory, luteal, and ischemic) and hormone levels (estradiol, testosterone, progesterone, and neuropeptide Y) on vocal fold vibrations in reproductive and postmenopausal women. Method Glottal area waveforms were extracted from high-speed videoendoscopy during sustained phonation, inhalation phonation, and voice onset/offset in the reproductive ( = 15) and postmenopausal ( = 13) groups. Linear mixed-model analysis was conducted to evaluate hormone levels and high-speed videoendoscopy outcome variables between the reproductive and postmenopausal groups. Read More

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The novel vasopressin receptor (V1aR) antagonist SRX246 reduces anxiety in an experimental model in humans: a randomized proof-of-concept study.

Psychopharmacology (Berl) 2021 May 10. Epub 2021 May 10.

National Institute of Mental Health, Bethesda, MD, USA.

Rationale: Arginine vasopressin (AVP) is a neuropeptide that modulates both physiological and emotional responses to threat. Until recently, drugs that target vasopressin receptors (V1a) in the human central nervous system were unavailable. The development of a novel V1a receptor antagonist, SRX246, permits the experimental validation of vasopressin's role in the regulation of anxiety and fear in humans. Read More

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Lidocaine before esophageal manometry and ambulatory pH monitoring: A randomized controlled trial.

Neurogastroenterol Motil 2021 May 10:e14167. Epub 2021 May 10.

Centre hospitalier de l'Université de Montréal (CHUM), Montréal, Québec, Canada.

Background: Lidocaine is commonly applied to improve the tolerance of esophageal manometry (EM) and ambulatory pH monitoring (PM). We recently published data suggesting a benefit to this practice and we aimed to confirm these findings in a randomized trial.

Methods: We conducted a double-blind, randomized trial of lidocaine nasal spray versus placebo (saline) before EM and PM. Read More

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The effect of Cornus mas extract consumption on bone biomarkers and inflammation in postmenopausal women: A randomized clinical trial.

Phytother Res 2021 May 10. Epub 2021 May 10.

Radiation Biology Research Center, Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.

The drastic decrease in estrogen levels in menopausal women can elevate bone resorption and osteoporosis. Cornus mas extract (C. mas extract) is a potential candidate for treating menopausal-related bone complications because of its phytoestrogen and anti-inflammatory contents. Read More

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Efficacy and Safety of Orally Administered Acotiamide Extended-Release Tablets Among Functional Dyspepsia-Postprandial Distress Syndrome Patients: A Randomized, Double-Blind, Multicenter Study.

Cureus 2021 Apr 8;13(4):e14361. Epub 2021 Apr 8.

Clinical Development and Medical Affairs, Hetero Labs Limited, Hyderabad, IND.

Background: Acotiamide, is the world's first-in-class, prokinetic drug and world's first approved treatment for postprandial distress syndrome (PDS) symptoms of functional dyspepsia (FD). An extended-release (ER) formulation of this drug product, developed first-time in the world has been evaluated in phase 3, a comparative trial to explore the efficacy and safety in patients with FD-PDS.

Methods: In this study, 219 patients with FD-PDS aged 18-65 years were randomized (1:1) to receive either acotiamide ER 300 mg once daily or acotiamide 100 mg three times daily for four weeks. Read More

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Reflux, Intraocular Pressure Variation and Pain Following Intravitreal Ranibizumab Injections Using 30-Gauge or 32-Gauge Needles for Patients With Retinal Pathologies: A Randomized Clinical Trial.

Cureus 2021 Apr 6;13(4):e14320. Epub 2021 Apr 6.

Ophthalmology, Queens University, Kingston, CAN.

Purpose: To compare reflux, intraocular pressure (IOP) variation and pain following intravitreal (IV) injections using 30-gauge and 32-gauge needles in patients with retinal pathologies in Saudi Arabia.

Methods: A double-blind randomized clinical trial was conducted in 2018. Participants were randomized to receive IV injections of Ranibizumab using 30-gauge (Gr) or 32-gauge (Gr) needles. Read More

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Efficacy and Safety of (Xueshuantong) in Patients With Acute Ischemic Stroke (EXPECT) Trial: Rationale and Design.

Front Pharmacol 2021 22;12:648921. Epub 2021 Apr 22.

Institute for Brain Disorders, Beijing University of Chinese Medicine, Beijing, China.

Although revascularization treatment is recommended as the first-line therapy for patients with non-minor acute ischemic stroke (AIS), it only benefits a minority of patients. Previous studies have reported the positive effects of (PNS) (Xueshuantong lyophilized powder) on AIS, however, there have been no rigorous trials. This study aims to assess the efficacy and safety of PNS therapy for patients with AIS. Read More

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Safety and Tolerability of GRF6019 Infusions in Severe Alzheimer's Disease: A Phase II Double-Blind Placebo-Controlled Trial.

J Alzheimers Dis 2021 May 3. Epub 2021 May 3.

Alkahest Inc., San Carlos, CA, USA.

Background: The plasma fraction GRF6019 shows multiple benefits on brain aging in mice, including enhanced cognition, neurogenesis, and synaptic density, as well as reduced neuroinflammation.

Objective: To evaluate the safety, tolerability, and preliminary efficacy of GRF6019 in patients with severe Alzheimer's disease (AD).

Methods: A phase II, double-blind, placebo-controlled study in patients with severe AD (Mini-Mental State Examination score 0-10). Read More

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Effect of KBP-5074 on Blood Pressure in Advanced Chronic Kidney Disease: Results of the BLOCK-CKD Study.

Hypertension 2021 May 10:HYPERTENSIONAHA12117073. Epub 2021 May 10.

Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.).

In patients with resistant or poorly controlled hypertension and advanced chronic kidney disease, mineralocorticoid receptor antagonists are recommended; however, hyperkalemia limits their use. BLOCK-CKD was a phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study that evaluated the safety, efficacy, and pharmacokinetics of KBP-5074, a nonsteroidal mineralocorticoid receptor antagonist, for uncontrolled hypertension in patients with stage 3b/4 chronic kidney disease. The study tested the hypothesis that addition of KBP-5074 to standard treatment lowers blood pressure without increased risk of hyperkalemia. Read More

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Letter comments on: "A comparison of the efficacy of autologous fibrin glue/platelet-poor plasma versus suction drainage in preventing hematoma and seroma in rhytidectomy: A randomized, double-blind, controlled study".

J Plast Reconstr Aesthet Surg 2021 Apr 22. Epub 2021 Apr 22.

16th Department, Plastic Surgery Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing 100144, PR China. Electronic address:

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Efficacy and safety of a single intra-articular injection of 6 ml Hylan G-F 20 compared to placebo in Chinese patients with symptomatic knee osteoarthritis : C-SOUND study, a 26-week multicenter double-blind randomized placebo-controlled trial in China.

BMC Musculoskelet Disord 2021 May 8;22(1):428. Epub 2021 May 8.

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, No.639 Zizaoju Road, Huangpu District, Shanghai, China.

Background: Single 6 ml Hylan G-F 20 injection, is indicated for knee osteoarthritis patients who have failed to respond to non-pharmacologic therapy and/or simple analgesics. To obtain more thorough understanding of the clinical efficacy and safety, a randomized clinical trial was conducted comparing intra-articular (IA) administration of single 6 ml Hylan G-F 20 injection versus placebo in knee OA patients of Chinese ethnicity.

Methods: This was a randomized, multi-center, double-blind, placebo-controlled clinical trial conducted in 21 centers across China. Read More

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Eltrombopag for Post-Transplantation Thrombocytopenia: Results of Phase II Randomized, Double-Blind, Placebo-Controlled Trial.

Transplant Cell Ther 2021 May 6;27(5):430.e1-430.e7. Epub 2021 Feb 6.

Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address:

Prolonged thrombocytopenia occurs in up to 37% of patients after hematopoietic stem cell transplantation (HSCT) and is associated with adverse prognosis and increased risk of bleeding. Eltrombopag, a thrombopoietin receptor agonist, can increase platelet counts in thrombocytopenic patients. We conducted a phase II study, adaptively randomizing patients at ≥35 days post-HSCT to receive placebo or eltrombopag at a platelet count ≤20,000/µL for 7 days or platelet transfusion-dependent and a neutrophil count ≥1500/µL. Read More

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The effect of omega3 fatty acid supplementation on PPARγ and UCP2 expressions, resting energy expenditure, and appetite in athletes.

BMC Sports Sci Med Rehabil 2021 May 8;13(1):48. Epub 2021 May 8.

Department of Community Nutrition, Faculty of Nutrition, Tabriz University of Medical Sciences, Tabriz, Iran.

Background: Omega3 fatty acids as a ligand of energy-related genes, have a role in metabolism, and energy expenditure. These effects are due to changes in the expression of peroxisome proliferator-activated receptor-gamma (PPARγ) and uncoupling protein2 (UCP2). This study evaluated the effect of omega3 supplements on PPARγ mRNA expression and UCP2 mRNA expression and protein levels, as regulators of energy metabolism, resting energy expenditure (REE), and appetite in athletes. Read More

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Maternal obesity and baseline vitamin D insufficiency alter the response to vitamin D supplementation: a double-blind, randomized trial in pregnant women.

Am J Clin Nutr 2021 May 8. Epub 2021 May 8.

Nutrition Innovation Centre for Food and Health (NICHE), School of Biomedical Sciences, Ulster University, Coleraine, Northern Ireland.

Background: The achievement of target 25-hydroxyvitamin D [25(OH)D] concentrations in pregnancy may be altered by maternal obesity.

Objective: The authors examined the effects of maternal supplementation of 10 μg compared with 20 μg vitamin D3/d on maternal and umbilical cord 25(OH)D. The secondary aim was to investigate the influence of maternal BMI (in kg/m2) on the response of the primary outcomes. Read More

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Intravenous tranexamic acid reduce postoperative drainage and pain after open elbow arthrolysis: A randomized controlled trial.

J Shoulder Elbow Surg 2021 May 5. Epub 2021 May 5.

Department of Orthopedics, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, P. R. China. Electronic address:

Background: Open elbow arthrolysis (OEA), which has become an established treatment for post-traumatic elbow stiffness (PTES), requires complete release of contracture tissue and wide excision of ectopic bone, which results in extensive bleeding. The aim of the present study is to evaluate the efficacy of intravenous tranexamic acid (TXA) on postoperative drainage, calculated blood loss and early clinical outcomes in patients undergoing OEA.

Methods: A double-blind, randomized, placebo-controlled trial including 96 patients undergoing OEA was undertaken. Read More

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Ozone therapy versus surgery for lumbar disc herniation: a randomized double-blind controlled trial.

Complement Ther Med 2021 May 5:102724. Epub 2021 May 5.

Research Network on Health Services in Chronic Diseases (REDISSEC), Madrid, Spain; Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain; Evaluation Unit of the Canary Islands Health Service (SESCS), Tenerife, Spain.

Objectives: Surgery is the treatment of choice for symptomatic disc herniation after conservative management. Several studies have suggested the potential utility of intradiscal ozone infiltration in this pathology. The aim of this trial was to compare intradiscal ozone infiltration vs. Read More

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Efficacy of a low-dose candidate malaria vaccine, R21 in adjuvant Matrix-M, with seasonal administration to children in Burkina Faso: a randomised controlled trial.

Lancet 2021 May 5. Epub 2021 May 5.

Novavax, Gaithersburg, MD, USA.

Background: Stalled progress in controlling Plasmodium falciparum malaria highlights the need for an effective and deployable vaccine. RTS,S/AS01, the most effective malaria vaccine candidate to date, demonstrated 56% efficacy over 12 months in African children. We therefore assessed a new candidate vaccine for safety and efficacy. Read More

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The formulation and efficacy of topical in treating Melasma: a randomized double-blind, placebo-controlled trial.

J Complement Integr Med 2021 May 10. Epub 2021 May 10.

Pharmaceutical Sciences Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.

Objectives: An acquired melanin-related hyperpigmentation that occurs in sun exposure areas is Melasma which presents as gray-brown ridges and macules with prominent margins on the skin. The aim of this assay was to assess the formulation and efficacy of topical among Melasma patients.

Methods: This study was a 30 days double-blind, randomized clinical trial in Melasma with a placebo group. Read More

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A Randomized Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Study of the Novel Myostatin Inhibitor Apitegromab (SRK-015): A Potential Treatment for Spinal Muscular Atrophy.

Adv Ther 2021 May 8. Epub 2021 May 8.

Medpace Clinical Pharmacology, Cincinnati, OH, USA.

Introduction: Apitegromab (SRK-015) is an anti-promyostatin monoclonal antibody under development to improve motor function in patients with spinal muscular atrophy, a rare neuromuscular disease. This phase 1 double-blind, placebo-controlled study assessed safety, pharmacokinetic parameters, pharmacodynamics (serum latent myostatin), and immunogenicity of single and multiple ascending doses of apitegromab in healthy adult subjects.

Methods: Subjects were administered single intravenous ascending doses of apitegromab of 1, 3, 10, 20, 30 mg/kg or placebo, and multiple intravenous ascending doses of apitegromab of 10, 20, 30 mg/kg or placebo. Read More

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Safety, immunogenicity, and efficacy of NDV-3A against Staphylococcus aureus colonization: A phase 2 vaccine trial among US Army Infantry trainees.

Vaccine 2021 May 4. Epub 2021 May 4.

NovaDigm Therapeutics, Inc., Grand Forks, ND, United States.

Background: Military trainees are at increased risk for Staphylococcus aureus colonization and infection. Disease prevention strategies are needed, but a S. aureus vaccine does not currently exist. Read More

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Time-of-day effects of consumption of fish oil-enriched sausages on serum lipid parameters and fatty acid composition in normolipidemic adults: A randomized, double-blind, placebo-controlled, and parallel-group pilot study.

Nutrition 2021 Mar 24;90:111247. Epub 2021 Mar 24.

Healthy Food Science Research Group, Cellular and Molecular Biotechnology Research Institute, National Institute of Advanced Industrial Science and Technology, Tsukuba, Ibaraki, Japan; Department of Applied Biological Science, Graduate School of Science and Technology, Tokyo University of Science, Noda, Chiba, Japan; Department of Computational Biology and Medical Sciences, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa, Chiba, Japan; School of Integrative and Global Majors, University of Tsukuba, Tsukuba, Ibaraki, Japan. Electronic address:

Objectives: The body clock controls diurnal rhythms of nutrient digestion, absorption, and metabolism. Fish oil (FO) contains abundant ω-3 polyunsaturated fatty acids (PUFA), including docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), that are thought to lower triglyceride (TG) levels. This randomized, placebo-controlled, double-blind, parallel-group trial aimed to confirm the effects of the time of FO intake on TG in healthy Japanese adults. Read More

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The efficacy and acceptability of hybrid electroconvulsive therapy compared with standard electroconvulsive therapy for schizophrenia patients: A parallel-group, double-blind, randomized, controlled trial.

Brain Stimul 2021 May 4;14(3):737-739. Epub 2021 May 4.

Brain Function and Psychosomatic Medicine Institute, Second People's Hospital of Huizhou, Huizhou, Guangdong, China; Department of Psychiatry, Shenzhen Kangning Hospital, and Shenzhen Mental Health Center, Shenzhen, Guangdong, China. Electronic address:

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Hydroxychloroquine reduces interleukin-6 levels after myocardial infarction: The randomized, double-blind, placebo-controlled OXI pilot trial.

Int J Cardiol 2021 May 4. Epub 2021 May 4.

Heart and Lung Center, Helsinki University Hospital, Helsinki University, Helsinki, Finland. Electronic address:

Objectives: To determine the anti-inflammatory effect and safety of hydroxychloroquine after acute myocardial infarction.

Method: In this multicenter, double-blind, placebo-controlled OXI trial, 125 myocardial infarction patients were randomized at a median of 43 h after hospitalization to receive hydroxychloroquine 300 mg (n = 64) or placebo (n = 61) once daily for 6 months and, followed for an average of 32 months. Laboratory values were measured at baseline, 1, 6, and 12 months. Read More

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Comparison of the Efficacy of Different Concentrations of Diclofenac Sodium Phonophoresis (1.16% vs 2.32%) in Patients with Knee Osteoarthritis: a Randomized Double-Blind Controlled Trial.

Acta Chir Orthop Traumatol Cech 2021 ;88(2):117-123

Istanbul Medipol University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Istanbul, Turkey.

PURPOSE OF THE STUDY The objective of the present study is to compare the efficacy of two different concentrations of diclofenac sodium phonophoresis (DSPH) (1.16% vs 2.32%) in patients with knee osteoarthritis (OA). Read More

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Efficacy and safety of ceftobiprole in patients aged 65 years or older: a  analysis of three Phase III studies.

Future Microbiol 2021 May 7. Epub 2021 May 7.

Basilea Pharmaceutica International Ltd., Basel, Switzerland.

To evaluate the efficacy and safety of ceftobiprole in patients aged ≥65 years. We conducted a analysis of three randomized, double-blind, Phase III studies in patients with acute bacterial skin and skin structure infections, community-acquired pneumonia and hospital-acquired pneumonia. Findings for patients aged ≥65 years (n = 633) were consistent with those for the overall study populations, although a trend toward improved outcomes was reported in some subgroups, for example, patients aged ≥75 years with community-acquired pneumonia were more likely to achieve an early clinical response with ceftobiprole than comparator (treatment difference 16. Read More

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GLPG1205, a GPR84 Modulator: Safety, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects.

Clin Pharmacol Drug Dev 2021 May 7. Epub 2021 May 7.

Galapagos, Mechelen, Belgium.

GLPG1205 is a modulator of GPR84, a G-protein-coupled receptor reported to be associated with several diseases. Safety, tolerability, pharmacokinetics, and pharmacodynamics of GLPG1205 in healthy subjects were evaluated in 2 randomized, double-blind, placebo-controlled, single-site, phase 1 studies. In study 1, 16 (aged 21-48 years) and 24 (24-50 years) healthy men received single doses of GLPG1205 10 to 800 mg, and GLPG1205 50, 100, or 200 mg once daily for 14 days, respectively, or placebo. Read More

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Design and rationale of the EMPA-VISION trial: investigating the metabolic effects of empagliflozin in patients with heart failure.

ESC Heart Fail 2021 May 6. Epub 2021 May 6.

Oxford Centre for Clinical Magnetic Resonance Research (OCMR), Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK.

Aims: Despite substantial improvements over the last three decades, heart failure (HF) remains associated with a poor prognosis. The sodium-glucose co-transporter-2 inhibitor empagliflozin demonstrated significant reductions of HF hospitalization in patients with HF independent of the presence or absence of type 2 diabetes mellitus in the EMPEROR-Reduced trial and cardiovascular mortality in the EMPA-REG OUTCOME trial. To further elucidate the mechanisms behind these positive outcomes, this study aims to determine the effects of empagliflozin treatment on cardiac energy metabolism and physiology using magnetic resonance spectroscopy (MRS) and cardiovascular magnetic resonance (CMR). Read More

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Saffron improves life and sleep quality, glycemic status, lipid profile and liver function in diabetic patients: A double-blind, placebo-controlled, randomized clinical trial.

Int J Clin Pract 2021 May 7:e14334. Epub 2021 May 7.

Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

Background: Type 2 diabetes (T2D) is a metabolic disorder that is related to hyperglycemia, hyperlipidemia, and liver dysfunction and has detrimental effects on a patient's mental health. Hence, the current study investigated the effects of saffron supplementation on dietary intake, anthropometric measures, mood, sleep quality, and metabolic biomarkers in overweight/obese patients with T2D.

Methods: In a double-blind, randomized controlled trial, 70 overweight/obese patients with T2D were randomly allocated to two groups and received 100 mg/day saffron or placebo for eight weeks. Read More

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