66,775 results match your criteria double-blind placebo-controlled

Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.

Lancet 2021 May 7. Epub 2021 May 7.

Research, Aurinia Pharmaceuticals, Victoria, BC, Canada. Electronic address:

Background: Voclosporin, a novel calcineurin inhibitor approved for the treatment of adults with lupus nephritis, improved complete renal response rates in patients with lupus nephritis in a phase 2 trial. This study aimed to evaluate the efficacy and safety of voclosporin for the treatment of lupus nephritis.

Methods: This multicentre, double-blind, randomised phase 3 trial was done in 142 hospitals and clinics across 27 countries. Read More

View Article and Full-Text PDF

Apatinib as second-line or later therapy in patients with advanced hepatocellular carcinoma (AHELP): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial.

Lancet Gastroenterol Hepatol 2021 May 7. Epub 2021 May 7.

Department of Intervention, Fujian Cancer Hospital, Fuzhou, China.

Background: Inhibition of vascular endothelial growth factor receptor (VEGFR) has shown antitumour activity in advanced hepatocellular carcinoma, but few studies of VEGFR inhibitors have been done in populations with a high prevalence of hepatitis B virus infection. The aim of this study was to evaluate the efficacy and safety of apatinib in patients with pretreated advanced hepatocellular carcinoma.

Methods: AHELP was a randomised, double-blind, placebo-controlled, phase 3 trial done at 31 hospitals in China, in patients (aged ≥18 years) with advanced hepatocellular carcinoma who had previously been refractory or intolerant to at least one line of systemic chemotherapy or targeted therapy. Read More

View Article and Full-Text PDF

Cocoa-flavanols enhance moderate-intensity pulmonary [Formula: see text] kinetics but not exercise tolerance in sedentary middle-aged adults.

Eur J Appl Physiol 2021 May 10. Epub 2021 May 10.

School of Sport and Exercise Science, Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, UK.

Introduction: Cocoa flavanols (CF) may exert health benefits through their potent vasodilatory effects, which are perpetuated by elevations in nitric oxide (NO) bioavailability. These vasodilatory effects may contribute to improved delivery of blood and oxygen (O) to exercising muscle.

Purpose: Therefore, the objective of this study was to examine how CF supplementation impacts pulmonary O uptake ([Formula: see text]) kinetics and exercise tolerance in sedentary middle-aged adults. Read More

View Article and Full-Text PDF

A Double-Blind, Controlled, Crossover Trial of Amlodipine on Iron Overload Status in Transfusion Dependent ꞵ-Thalassemia Patients.

Int J Clin Pract 2021 May 10:e14337. Epub 2021 May 10.

Student of Medical Surgical Nursing, Student Research Committee, Mashhad University of Medical Sciences, Mashhad, Iran.

Background And Aim: This study examined whether administration of amlodipine could improve myocardial iron loading status in patients with transfusion dependent β-thalassemia (TDT), through a placebo-controlled, crossover study.

Methods: Amlodipine (5 mg, daily) or placebo were prescribed to all patients (n = 19) for 6 months, and after a 2-week washout period, patients were crossed over to the other group. The efficacy of amlodipine on iron loading was assessed by measuring myocardial T2*-weighted magnetic resonance imaging (MRI T2*, millisecond [ms]) and serum ferritin (ng/mL). Read More

View Article and Full-Text PDF

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

View Article and Full-Text PDF

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

View Article and Full-Text PDF

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

View Article and Full-Text PDF

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

View Article and Full-Text PDF

Ripretinib in treatment of repeatedly relapsing rectal gastrointestinal stromal tumor: a case report.

Ann Palliat Med 2021 Apr;10(4):4994-4998

Department of Gastrointestinal Surgery, The First Affiliated Hospital, Chongqing Medical University, Chongqing, China.

Gastrointestinal stromal tumor (GIST) is the most common type of gastrointestinal mesenchymal tumor. Fewer than 2% of patients with metastatic GIST treated with imatinib experience a pathologic complete response. Furthermore, response to imatinib and subsequent-line tyrosine kinase inhibitor is limited by most patients developing drug resistance; median time to progression is 2 years for imatinib, and about half a year for sunitinib and regorafenib. Read More

View Article and Full-Text PDF

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

View Article and Full-Text PDF

Rapid amelioration of anorexia nervosa in a male adolescent during metreleptin treatment including recovery from hypogonadotropic hypogonadism.

Eur Child Adolesc Psychiatry 2021 May 9. Epub 2021 May 9.

Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.

With this case report we support our medical hypothesis that metreleptin treatment ameliorates starvation related emotional, cognitive and behavioral symptomatology of anorexia nervosa (AN) and show for the first time strong effects in a male patient with AN. A 15.9 year old adolescent with severe AN of eight-month duration was treated off-label with metreleptin. Read More

View Article and Full-Text PDF

HPV vaccination to prevent recurrence of Anal Intraepithelial Neoplasia in HIV+ MSM: a randomised, placebo-controlled multicentre trial.

AIDS 2021 May 5. Epub 2021 May 5.

Department of Dermatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands Department of Internal Medicine, Division of Infectious Diseases, Amsterdam Institute for Infection and Immunity (AII), Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands Department of Pathology, Cancer Center Amsterdam (CCA), Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands Department of Infectious Diseases, Public Health Service of Amsterdam (GGD Amsterdam), Amsterdam, The Netherlands Department of Dermatology, OLVG, Amsterdam, The Netherlands DC Klinieken Lairesse, Amsterdam, The Netherlands Department of Pathology, Cancer Center Amsterdam (CCA), Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands DDL Diagnostic Laboratory, Rijswijk, The Netherlands Center for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, the Netherlands Department of Epidemiology and Data Science, Amsterdam Public Health Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands STI Outpatient Clinic, Department of Infectious Diseases, Public Health Service of Amsterdam (GGD Amsterdam), Amsterdam, The Netherlands. Authors contributed equally.

Objective: Anal cancer precursor lesions high-grade anal intraepithelial neoplasia (HGAIN) are highly prevalent among HIV+ men-who-have-sex-with-men (MSM). Treatment of HGAIN is frustrated by high recurrence rates. We investigated the efficacy of the quadrivalent human papillomavirus (qHPV) vaccine as post-treatment adjuvant in preventing HGAIN recurrence in HIV+MSM. Read More

View Article and Full-Text PDF

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

View Article and Full-Text PDF

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

View Article and Full-Text PDF

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

View Article and Full-Text PDF

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

View Article and Full-Text PDF

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

View Article and Full-Text PDF

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

View Article and Full-Text PDF

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

View Article and Full-Text PDF

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

View Article and Full-Text PDF

Evaluation of Pexion (imepitoin) for treatment of storm anxiety in dogs: A randomised, double-blind, placebo-controlled trial.

Vet Rec 2021 May 21;188(9):e18. Epub 2021 Jan 21.

Department of Clinical Sciences, North Carolina State University College of Veterinary Medicine, Raleigh, North Carolina, USA.

Background: While often grouped with other noise aversions, fearful behaviour during storms is considered more complex than noise aversion alone. The objective here was to assess the effect of imepitoin for the treatment of storm anxiety in dogs.

Methods: In this double-blind, placebo-controlled randomised study, eligible dogs completed a baseline then were randomised to receive either imepitoin (n = 30; 30 mg/kg BID) or placebo (n = 15) for 28 days. Read More

View Article and Full-Text PDF

The effect of peri-operative dexmedetomidine on the incidence of postoperative delirium in cardiac and non-cardiac surgical patients: a randomised, double-blind placebo-controlled trial.

Anaesthesia 2021 May 7. Epub 2021 May 7.

Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany.

Delirium occurs commonly following major non-cardiac and cardiac surgery and is associated with: postoperative mortality; postoperative neurocognitive dysfunction; increased length of hospital stay; and major postoperative complications and morbidity. The aim of this study was to investigate the effect of peri-operative administration of dexmedetomidine on the incidence of postoperative delirium in non-cardiac and cardiac surgical patients. In this randomised, double-blind placebo-controlled trial we included 63 patients aged ≥ 60 years undergoing major open abdominal surgery or coronary artery bypass graft surgery with cardiopulmonary bypass. Read More

View Article and Full-Text PDF

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

View Article and Full-Text PDF

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

View Article and Full-Text PDF

Novel application of a discrete time-to-event model for randomized oral immunotherapy clinical trials with repeat food challenges.

Stat Med 2021 May 6. Epub 2021 May 6.

Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Palo Alto, California, USA.

The evaluation of double-blind, placebo-controlled food challenges (DBPCFC) generally focuses on a participant passing a challenge at a predetermined dose, and does not consider the dose of reaction for those who fail or are censored due to study discontinuation. Further, a number of food allergy trials have incorporated multiple DBPCFCs throughout the duration of the study in order to evaluate changes in reaction over time including sustained unresponsiveness from treatment. Outcomes arising from these trials are commonly modeled using Chi-squared or Fisher's exact tests at each time point. Read More

View Article and Full-Text PDF

Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study.

Ther Adv Musculoskelet Dis 2021 20;13:1759720X211006964. Epub 2021 Apr 20.

Department of Rheumatology and Immunity, Center of Clinical Immunology, Peking University People's Hospital, Xicheng District, Beijing, P.R. China.

Introduction: To assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX).

Methods: This was a 52-week, randomized, double-blind, placebo controlled, phase III study in patients with RA who had an inadequate response to MTX. Patients ( = 290) receiving stable background MTX were randomly assigned (1:1) to receive placebo or baricitinib 4 mg once daily with a primary endpoint at week 12. Read More

View Article and Full-Text PDF

Fluvoxamine: A Review of Its Mechanism of Action and Its Role in COVID-19.

Front Pharmacol 2021 20;12:652688. Epub 2021 Apr 20.

GlobalCures, Inc., Newton, MA, United States.

Fluvoxamine is a well-tolerated, widely available, inexpensive selective serotonin reuptake inhibitor that has been shown in a small, double-blind, placebo-controlled, randomized study to prevent clinical deterioration of patients with mild coronavirus disease 2019 (COVID-19). Fluvoxamine is also an agonist for the sigma-1 receptor, through which it controls inflammation. We review here a body of literature that shows important mechanisms of action of fluvoxamine and other SSRIs that could play a role in COVID-19 treatment. Read More

View Article and Full-Text PDF

Continuing versus withdrawing ixekizumab treatment in patients with axial spondyloarthritis who achieved remission: efficacy and safety results from a placebo-controlled, randomised withdrawal study (COAST-Y).

Ann Rheum Dis 2021 May 6. Epub 2021 May 6.

Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.

Objectives: The objective of COAST-Y was to evaluate the effect of continuing versus withdrawing ixekizumab (IXE) in patients with axial spondyloarthritis (axSpA) who had achieved remission.

Methods: COAST-Y is an ongoing, phase III, long-term extension study that included a double-blind, placebo (PBO)-controlled, randomised withdrawal-retreatment period (RWRP). Patients who completed the originating 52-week COAST-V, COAST-W or COAST-X studies entered a 24-week lead-in period and continued either 80 mg IXE every 2 (Q2W) or 4 weeks (Q4W). Read More

View Article and Full-Text PDF