The Pharmacodynamic Impact of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, on Circulating Levels of Inflammatory Biomarkers in Patients with Psoriatic Arthritis: Substudy Results from a Phase III, Randomized, Placebo-Controlled Trial (PALACE 1) by Peter H. Schafer, Peng Chen, Lorraine Fang, Andrew Wang, Rajesh Chopra

“…Apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated effectiveness (versus placebo) for treatment of active psoriatic arthritis in the psoriatic arthritis long-term assessment of clinical efficacy (PALACE) phase III clinical trial program. …”
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Technologically-Treated Polyclonal Affinity-Purified Antibodies to the Tumor Necrosis Factor-α, Brain Specific S-100 Protein and Histamine in Treatment of Functional Dyspepsia: Results of the Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial by Yu. O. Shulpekova, I. V. Maev, V. B. Grinevich, I. B. Khlynov, Yu. G. Shvarts, V. T. Ivashkin

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Descemet Endothelial Thickness Comparison Trial 1 (DETECT 1): outcome masked, placebo-controlled trial comparing two types of corneal transplant surgeries and effect of rho kinase inhibitors on endothelial cell loss protocol by Thomas M Lietman, Jennifer Rose-Nussbaumer, Bennie H Jeng, Benjamin F Arnold, Winston Chamberlain, Charles C Lin, Jennifer Y Li, William Gensheimer, Jameson Clover, Nicole Varnado, Sarah Abdelrahman

“…The patients will be randomly assigned in a 2×2 factorial design to one of the following treatment groups: group 1—ultrathin Descemet stripping endothelial keratoplasty (UT-DSAEK) plus topical ripasudil 0.4%; group 2—UT-DSAEK plus topical placebo; group 3—Descemet membrane endothelial keratoplasty (DMEK) plus topical ripasudil 0.4% and group 4—DMEK plus topical placebo. …”
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Safety and Immunogenicity of the Tetravalent Recombinant COVID-19 Protein Vaccine SCTV01E in Children and Adolescents Aged 3 to 17 Years: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial by Fengcai Zhu, Ting Huang, Pengfei Jin, Linglin Zhang, Zhongqiang Jin, Wenli Zhang, Dongya Yuan, Zhong Wang, Yusong Deng, Jiaxin Li, Xiao Shen, Yongpan Fu, Jian Li, Xinjie Yang, Jing Li, Liangzhi Xie

“…Overall, 127 (59.3%) participants receiving SCTV01E and 9 (16.7%) receiving a placebo reported adverse events (AEs), most of which were Grade 1 or 2. …”
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A Randomized, Placebo-Controlled, Single-Center, Crossover Study to Evaluate the Effects of Pre-Meal Whey Protein Microgel on Post-Prandial Glucometabolic and Amino Acid Response in People with Type 2 Diabetes and Overweight or Obesity by Ian J Neeland, Luiz H de Gregório, Roberto Zagury, Bo Ahrén, Joel Neutel, Christian Darimont, John Corthesy, Yohan Grzywinski, Emilie Perrin, Maximilian von Eynatten, Odd Erik Johansen

“…After an overnight fast and a standardized breakfast, 10 g (125 mL) WPM (40 kcal) or placebo (125 mL water, 0 kcal) was consumed 15 min ahead of the mixed-nutrient meal. …”
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Comparison of the impact of intermittent fasting diet alone or in conjunction with probiotic supplementation versus calorie-restricted diet on inflammatory, oxidative stress, and antioxidant capacity biomarkers in women with polycystic ovary syndrome: A randomized placebo-controlled trial by Sepide Talebi, Sakineh Shab-Bidar, Gholamreza Askari, Hamed Mohammadi, Ashraf Moini, Kurosh Djafarian

“…Participants were randomly assigned to one of three groups: 14:10 eTRE with probiotic supplementation (n = 30), 14:10 eTRE with placebo supplementation (n = 30), or DCR with placebo supplementation (n = 30). …”
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Risk of diabetic ketoacidosis caused by sodium glucose cotransporter-2 inhibitors in patients with type 1 diabetes: a systematic review and network meta-analysis of randomized cont... by Ying Liu, Shiwen Yang, Aidou Jiang, Dan Zou, Zhaoyang Chen, Na Su, Na Su

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Phase II randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of MLC1501 in patients with stroke: the MLC1501 study Assessing Efficacy in post-STrOke Subjects with mOtor deficits (MAESTOSO) study protocol by Narayanaswamy Venketasubramanian, Deidre Anne De Silva, Christopher P L H Chen, Cyrus G Escabillas, John Harold Hiyadan, Johnny K Lokin, Romulo U Esagunde, Joel M Advincula, Christian Oliver C Co, Maria Epifania V Collantes, Annabelle Y Lao, Yeow-Hoay Koh, Carol Huilian Tham

“…Background MLC1501, consisting of four herbs, that is, Radix Astragali, Radix Angelicae sinensis, Rhizoma Chuanxiong, Radix Polygalae, has the same pharmacological properties as its precursors MLC601 and MLC901 which contain extracts of nine herbs and showed neuroprotective, anti-inflammatory and neurorestorative properties in non-clinical models, as well as clinical benefits in improving functional and neurological recovery after brain injuries.Aims To determine the efficacy of MLC1501 on motor recovery as measured by Fugl-Meyer motor Assessment (FMA) total score at 24 weeks in patients with ischaemic stroke (IS).Design A total of 300 patients aged >18 years, diagnosed with IS in the prior 2–10 days, with National Institute of Health Stroke Scale (NIHSS) total score of 8–18 and a combined score of ≥3 on NIHSS motor items 5A, 5B, 6A and/or 6B, will be randomised in a 1:1:1 ratio to receive oral placebo, MLC1501 low dose or MLC1501 high dose for 6 months. …”
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Efficacy and safety of glycyrrhizic acid and essential phospholipids (Phosphogliv) combination for alcoholic liver disease: results of the double-blind randomized placebo-controlled multicenter post-registration (phase IV) clinical trial «Jaguar» (PHG-M2/P03-12) by I. G. Bakulin, N. A. Bokhan, P. O. Bogomolov, N. I. Geyvandova, M. V. Matsiyevich, M. A. Vinnikova, V. G. Morozov, O. M. Khromtsova, G. S. Soldatova, O. Yu. Shiryayev, R. D. Ilyuk, K. V. Rybakova, A. G. Katkovskaya, S. V. Teplykh, A. A. Bagretsova, M. V. Krasnova, Ye. V. Alekseyeva, A. V. Anipchenko, Ye. V. Baskakov

“…Patients of the control group (group B) received placebo in the same regimen. The dynamics of serum alanine transaminase (ALT), aspartate transaminase (AST), liver scores by noninvasive FibroMax test was applied to assess the treatment efficacy and safety, along with change in quality of life of patients. …”
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Motor Neuron Disease Systematic Multi-Arm Adaptive Randomised Trial (MND-SMART): a multi-arm, multi-stage, adaptive, platform, phase III randomised, double-blind, placebo-controlled trial of repurposed drugs in motor neuron disease by Jeremy Chataway, Suvankar Pal, Charis Wong, Elizabeth Elliott, Jenna M Gregory, Siddharthan Chandran, Judith Newton, Shuna Colville, Maria Stavrou, Christopher J Weir, Nigel Stallard, Malcolm R Macleod, Michelle Steven, Richard Anthony Parker, Arpan R Mehta, Robert J Swingler, Mahesh K B Parmar, Rachel S Dakin, Jill Williamson

“…The first two drugs selected for evaluation in MND-SMART are trazodone and memantine.Methods and analysis Initially, up to 531 participants (177/arm) will be randomised 1:1:1 to oral liquid trazodone, memantine and placebo. The coprimary outcome measures are the Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) and survival. …”
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Efficacy of yeast beta-glucan 1,3/1,6 supplementation on respiratory infection, fatigue, immune markers and gut health among moderate stress adults in Klang Valley of Malaysia: protocol for a randomised, double-blinded, placebo-controlled, parallel-group study by Suzana Shahar, Kalavathy Ramasamy, Norhayati Ibrahim, Nur Nadia Mohamad Habibullah, Munirah Ismail, Mohd Zul Amin Kamaruddin, Shirley Gee Hoon Tang, Mohd Faisal Abdul Hamid

“…These participants will be randomised into three groups, receiving YBG 1,3/1,6 at either 120 mg, 204 mg or a placebo. The outcomes measures include respiratory infection symptoms, fatigue, mood state and quality of life assessed using Wisconsin Upper Respiratory Symptoms Scale, Multidimensional Fatigue Inventory, Profile of Mood State and Short Form 36 Health Survey Questionnaire, respectively. …”
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Efficacy and safety of glycyrrhizic acid combined to essential phospholipids (Phosphogliv) at non-alcoholic fatty liver disease: results of multicenter double blind randomized placebo-controlled post-registration clinical study (IV phase) «Gepard» (PHG-M2/P02-12) by V. T. Ivashkin, I. G. Bakulin, P. O. Bogomolov, M. V. Matsiyevich, N. I. Geyvandova, P. V. Koroy, S. V. Nedogoda, O. A. Sablin, L. G. Lenskaya, Ye. V. Beloborodova, A. A. Bagretsova, R. A. Abdulkhakov, M. F. Osipenko, I. V. Osipova, D. A. Pocheptsov, Ye. V. Chumachek, O. M. Khromtsova, Ye. V. Kuzmicheva

“…The basic group patients received Phosphogliv 5 mg/day as intravenous bolus injection for 2 weeks, followed by oral intake of 2 capsules t.i.d. for 10 weeks (the total treatment duration was 12 weeks), control group patients received placebo in the same mode. Serum levels of inflammatory marker adiponectin, NAFLD fibrosis score, treatment effect on quality of life and safety of patients were monitored. …”
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Safety, Tolerability, and Immunogenicity of the Invaplex_AR-Detox <i>Shigella</i> Vaccine Co-Administered with the dmLT Adjuvant in Dutch and Zambian Adults: Study Protocol for a Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase Ia/b Clinical Trial by Geert V. T. Roozen, Nsofwa Sukwa, Masuzyo Chirwa, Jessica A. White, Marcus Estrada, Nicole Maier, Kevin R. Turbyfill, Renee M. Laird, Akamol E. Suvarnapunya, Aicha Sayeh, Flavia D’Alessio, Candice Marion, Laura Pattacini, Marie-Astrid Hoogerwerf, Rajagopal Murugan, Manuela Terrinoni, Jan R. Holmgren, Sodiomon B. Sirima, Sophie Houard, Michelo Simuyandi, Meta Roestenberg

“…Methods: In a multi-center, randomized, double-blind, and placebo-controlled dose-escalation phase Ia/b trial, the safety, tolerability, and immunogenicity of three intramuscular vaccinations administered 4 weeks apart with 2.5 µg or 10 µg of Invaplex_AR-Detox vaccine, alone or in combination with 0.1 µg of the dmLT adjuvant, will first be assessed in a total of 50 healthy Dutch adults (phase Ia) and subsequently in 35 healthy Zambian adults (phase Ib) aged 18–50 years. …”
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Course of Hyperkalemia in Patients on Hemodialysis by Bruce Spinowitz, Steven Fishbane, Masafumi Fukagawa, Martin Ford, Nicolas Guzman, Anjay Rastogi

“…These post hoc analyses of the placebo arm of the phase 3b DIALIZE study (NCT03303521) explored the course of hyperkalemia in hemodialysis patients receiving placebo. …”
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Cardio-renal effect of dapagliflozin and dapagliflozin- saxagliptin combination on CD34 + ve hematopoietic stem cells (HSCs) and podocyte specific markers in type 2 diabetes (T2DM)... by Seshagiri Rao Nandula, Arad Jain, Sabyasachi Sen

“…Methods This is a pilot study evaluating low dose Dapagliflozin 10 mg or low dose Dapa + low dose Saxagliptin combination. 15 subjects were enrolled in 16 weeks, double-blind, three-arm, randomized placebo matched trial, with 10mg Dapa + Saxa placebo (n = 4), 10 mg Dapa + 5 mg Saxa (n = 5) Combo, And Dapa placebo + Saxa placebo (n = 6), Placebo groups. …”
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Cancelled: Effect of Cyber-Ostracism on the Mental Condition of Instagram Users by Cleoputri Yusainy, Intan Liana Putri, Lita Rakhmi Fadliilah, Gracia Maria Veronica, Ircham Darmawan, Wahyu Wicaksono

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The Effects of Morus alba and Acacia catechu on Quality of Life and Overall Function in Adults with Osteoarthritis of the Knee by Douglas S. Kalman, Susan J. Hewlings

“…In a randomized, double-blinded, placebo-controlled, parallel design, 135 subjects received UP1306, a standardized, proprietary extract of Morus alba and Acacia catechu, glucosamine chondroitin, or placebo for 12 weeks. …”
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Metformin increases mammographic breast density: a randomized controlled trial by Sadaf Alipour, Ladan Hosseini, Zohreh Forootan, Hadith Rastad, Leila Bayani, Mahboubeh Abedi, Bita Eslami

“…Methods A double-blind, placebo-controlled study was performed. A total of 151 premenopausal women received 500 mg metformin tablets twice a day for 6 months, or a placebo, were included. …”
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The efficacy and safety of fluvoxamine in patients with COVID-19: A systematic review and meta-analysis from randomized controlled trials. by Qiufeng Zhou, Guozheng Zhao, Yu Pan, Ying Zhang, Yuehua Ni

“…<h4>Results</h4>We pooled 4,711 participants from six RCTs (2,382 in the fluvoxamine group and 2,329 in the placebo group). Compared to the placebo group, the fluvoxamine group had a significantly lower rate of clinical deterioration (RR, 0.73; P = 0.004; 95% CI, 0.59 to 0.90; I2 = 0%) and hospitalization (RR, 0.76; P = 0.04; 95% CI, 0.59 to 0.99; I2 = 0%). …”
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Long Term Safety of Infliximab by Thomas F Schaible

“…Infliximab is a chimeric anti-tumour necrosis factor-alpha monoclonal antibody that has been studied for the treatment of Crohn’s disease and rheumatoid arthritis. In several placebo controlled, randomized clinical trials and open trials, 771 patients have been given infliximab (a further 192 received placebo). …”
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