Intranasal Pharmacokinetics of Morphine ARER, a Novel Abuse-Deterrent Formulation: Results from a Randomized, Double-Blind, Four-Way Crossover Study in Nondependent, Opioid-Experienced Subjects by Lynn R. Webster, Carmela Pantaleon, Matthew Iverson, Michael D. Smith, Eric R. Kinzler, Stefan Aigner

“…This randomized, double-blind, double-dummy, placebo-controlled, four-way crossover study assessed the PK of morphine and its active metabolite, M6G, from crushed intranasal Morphine ARER and intact oral Morphine ARER compared with crushed intranasal ER morphine following administration to nondependent, recreational opioid users. …”
Get full text

Efficacy of Curcumin on Treating Cancer Anorexia-Cachexia Syndrome in Locally or Advanced Head and Neck Cancer: A Double-Blind, Placebo-Controlled Randomised Phase IIa Trial (CurChexia) by Tawasapon Thambamroong, Kasan Seetalarom, Siriwimon Saichaemchan, Yanisa Pumsutas, Naiyarat Prasongsook

“…This constitutes a randomised, double-blind, placebo-controlled phase IIa study. Twenty patients with CAS in locally advanced or advanced head and neck cancer adequately nourished via a feeding tube were enrolled and randomised in a 1 : 1 ratio to receive oral curcumin (at a dose of 4000 mg daily) (n = 10) or placebo (n = 10) for 8 weeks. …”
Get full text

Comparison of Histological, Clinical, and Radiographic Outcomes of Postextraction Ridge Preservation by Allogenic Bone Grafting With and Without Injectable Platelet-Rich Fibrin: A Double-Blinded Randomized Controlled Clinical Trial by Mohammad Reza Talebi Ardakani, Zeinab Rezaei Esfahrood, Fatemeh Mashhadiabbas, Masoud Hatami

Get full text

Efficacy and safety of a generic remifentanil formulation versus fentanyl and Ultiva during general anaesthesia: A phase III, prospective, multi-centric, observer-blind, randomised controlled trial by Indrani Hemantkumar, Ashok Kumar Swain, Manjaree Mishra, Swati Singh, Challakere Lakshminarain Gurudatt, Janampet Bekkam Giridhar

“…An independent anaesthetist blinded to treatment allocation assessed efficacy and safety parameters. …”
Get full text

Embryo selection through non-invasive preimplantation genetic testing with cell-free DNA in spent culture media: a protocol for a multicentre, double-blind, randomised controlled trial by Jie Qiao, Yan Wang, Rong Li, Ping Liu, Liang Hu, Lin Zeng, Guimin Hao, Jin Huang, Bing Yao, Junzhao Zhao, Juanzi Shi, Liyi Cai, Xiu-Xia Wang, Yanwen Xu, Yuanqing Yao, Yichun Guan, Weiping Qian, Sijia Lu

Get full text

Intranasal Insulin Diminishes Postoperative Delirium and Elevated Osteocalcin and Brain Derived Neurotrophic Factor in Older Patients Undergoing Joint Replacement: A Randomized, Double-Blind, Placebo-Controlled Trial by Yang M, Zhou L, Long G, Liu X, Ouyang W, Xie C, He X

“…However, its impact on postoperative delirium and insulin sensitivity biomarkers remains unknown.Aim: This randomized, double-blind, placebo-controlled trial was to evaluate whether intranasal insulin reduces the incidence and severity of postoperative delirium (POD) in older patients undergoing joint replacement, and its effect on insulin sensitivity-related biomarkers.Methods: 212 older patients (≥ 65 years) were randomly assigned to receive either 40 IU of intranasal insulin (n=106) or a placebo (n=106) for 8 days. …”
Get full text

Immunogenicity and safety of a live attenuated varicella vaccine in children aged 1 to 12 years: A double-blind, randomized, parallel-controlled phase III clinical trial in China by Shiyuan Wang, Yang Zhang, Guifan Li, Jinhui Shi, Xianyun Chang, Hao Zhang, Fengcai Zhu, Jingxin Li, Kai Chu, Jinfang Sun

“…In this phase III, single-center, randomized, double-blind, active-controlled trial,1,200 healthy participants randomly assigned in a 1:1 ratio to receive one dose of either the test vaccine or the active control vaccine. …”
Get full text

Initial treatment with a single capsule containing half-dose quadruple therapy vs standard-dose dual therapy in hypertensive patients (QUADUAL): a randomized, blinded, crossover trial by Xiexiong Zhao, Tao Liu, Qiong Yang, Guoping Yang, Xingli Li, Xiaohong Tang, Jingle Li, Zhongshu Liang, Anying Li, Lixiong Zeng, Juan Wen, Xiaoyan Wang, Liping Peng, Wenjuan Wang, Jingjing Cai, Ye Chen, Miao Huang, Ruixuan Li, Ru Fu, Lin Zhao, Xiaogang Li, Weihong Jiang

“…Participants and researchers were blinded. The main outcomes were the reduction of blood pressure and safety outcomes. …”
Get full text

Double-blind, randomised, placebo-controlled trial to evaluate the effectiveness of late gestation oral melatonin supplementation in reducing induction of labour rates in nulliparous women: the MyTIME study protocol by Miranda Davies-Tuck, Emily Callander, Mary Sharp, Scott W White, Dorota A Doherty, Jane Warland, Zoe Bradfield, Lesley Kuliukas, Monique Rose, Amber Pettitt, Kylie Ekin, JA Keelan

“…Melatonin potentiates the action of oxytocin and may promote the spontaneous onset of labour; therefore, we will test the hypothesis that exogenous melatonin supplementation in late pregnancy will reduce the rate of labour induction by 30% or more.Methods and analyses This is a double-blind, randomised, placebo-controlled trial in nulliparous pregnant women to reduce IOL rates. …”
Get full text

Ultrasound-guided deep versus superficial continuous serratus anterior plane block for pain management in patients with multiple rib fractures: A prospective randomized double-blind clinical trial by Mohamed F. Mostafa, Mohamed Abdel-Moniem Bakr, Mohamed Ismail Seddik, Mohammed Mamdouh Mohammed Mahmoud, Gamal M.A. Ibrahim, Ahmed Talaat Ahmed

Get full text

Effect of transcranial direct current stimulation on postoperative sleep disturbance in older patients undergoing lower limb major arthroplasty: a prospective, double-blind, pilot, randomised controlled trial by Chunyan Li, Jie Yang, He Liu, Wen Tan, Song Zhang, Hongxing Zhang, Yuan Han, Mingshu Tao, Rongguang Liu, Jiaxing Fang, Dexian Chen, Qi Wei, Xingyu Xiong, Wenxin Zhao, Junli Cao

“…Background Postoperative sleep disturbance (PSD) is a common and serious postoperative complication and is associated with poor postoperative outcomes.Aims This study aimed to investigate the effect of transcranial direct current stimulation (tDCS) on PSD in older patients undergoing lower limb major arthroplasty.Methods In this prospective, double-blind, pilot, randomised, sham-controlled trial, patients 65 years and over undergoing lower limb major arthroplasty were randomly assigned to receive active tDCS (a-tDCS) or sham tDCS (s-tDCS). …”
Get full text

A Double-Blind, Randomized, Controlled Trial of Topical Polysporin Triple Compound Versus Topical Mupirocin for the Eradication of Colonization with Methicillin-Resistant Staphylococcus aureus in a Complex Continuing Care Population by S O’Grady, Z Hirji, B Pejcic-Karapetrovic, S Fung, H Dedier, J Takata-Shewchuk, K Zhang, J Conly

Get full text

Increased Macular Pigment Optical Density and Visual Acuity following Consumption of a Buttermilk Drink Containing Lutein-Enriched Egg Yolks: A Randomized, Double-Blind, Placebo-Controlled Trial by Sanne M. van der Made, Elton R. Kelly, Aize Kijlstra, Jogchum Plat, Tos T. J. M. Berendschot

“…One hundred and one subjects were recruited to participate in this randomized, double-blind, placebo-controlled parallel intervention trial. …”
Get full text

Active versus sham transcranial direct current stimulation (tDCS) as an adjunct to varenicline treatment for smoking cessation: Study protocol for a double-blind single dummy randomized controlled trial. by Laurie Zawertailo, Helena Zhang, Noreen Rahmani, Tarek K Rajji, Peter Selby

“…<h4>Methods</h4>This is a double-blind, sham-controlled randomized clinical trial where fifty healthy smokers will be recruited in Toronto, Canada. …”
Get full text

Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial) by Claus Thorn Ekstrøm, Patrick MacDonald Fisher, Gitte Moos Knudsen, Dea Siggaard Stenbæk, Anders Fink-Jensen, Mathias Ebbesen Jensen, Tobias Søgaard Juul

“…However, the efficacy of a single psilocybin administration and its potential neurobiological underpinnings still remain unknown.Methods and analysis To establish efficacy, we will investigate the effects of psilocybin-assisted therapy versus placebo in a randomised, double-blinded, placebo-controlled 12-week clinical trial. …”
Get full text

A Prospective, Crossover, Randomized, Double-Blind Clinical Study Comparing the Effectiveness and Ocular Comfort of 0.1% Hyaluronic Acid and 0.3% Hyaluronic Acid in Patients With Dry Eye Disease by Kim SJ, Yoo WS, Kwon LH, Kim RB, Yoon HJ, Yoon KC

“…Korea) to treat dry eye disease (DED).Methods: This study was designed as a prospective, crossover, randomized, and double-blind study. Patients aged > 19 years with DED level 2 or higher, corneal staining score > 1, and tear break-up time (TBUT) < 10s were included. …”
Get full text

A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer by Zhiwei Chen, Jianhua Chen, Dingzhi Huang, Wei Zhang, Lin Wu, Tienan Yi, Qiming Wang, Liang Han, Liping Tan, Yinyin Li, Zhihong Zhang, Na Li, Jie li, Tongmei Zhang, Ying Hu, Hongmei Sun, Youhua Wu, Zhiyong He, Runxiang Yang, Peng Cheng, Xingya Li, Jianhua Shi, Guohua Yu, Daiyuan Ma, Benjamin Xiaoyi Li, Xiangrong Dai, Michael Wong, Yujie Li, Xiaohui Yu, Shun Lu, for the Socazolimab Study Group

“…Abstract This is a randomized, double-blind, placebo-controlled phase 3 clinical trial (ClinicalTrials.gov, NCT04878016) conducted in 54 hospitals in China. …”
Get full text

Effect of Dexmedetomidine Added to Lidocaine Cartridge on the Level of Patient Sedation, Cooperation, and Patient and Surgeon Satisfaction during Mandibular Third-Molar Extraction Surgery: A Randomized Double-Blind Controlled Trial by Milad Etemadi Sh, Nasser Kaviani, Kimia Salimian, Golnaz Tajmiri

“…A total number of 26 healthy volunteers with symmetrical bilateral impacted mandibular third-molar teeth indicated for surgical removal were included in this double-blind randomized controlled trial. A single experienced surgeon performed two surgical extraction procedures within at least four-week time intervals using anesthetic cartridges containing “DEX + LIDO” or “LIDO alone” used randomly on each side for each patient. …”
Get full text

Polymerized-Type I Collagen Downregulates Inflammation and Improves Clinical Outcomes in Patients with Symptomatic Knee Osteoarthritis Following Arthroscopic Lavage: A Randomized, Double-Blind, and Placebo-Controlled Clinical Trial by Janette Furuzawa-Carballeda, Guadalupe Lima, Luis Llorente, Carlos Nuñez-Álvarez, Blanca H. Ruiz-Ordaz, Santiago Echevarría-Zuno, Virgilio Hernández-Cuevas

Get full text

Systematic bias between blinded independent central review and local assessment: literature review and analyses of 76 phase III randomised controlled trials in 45 688 patients with advanced solid tumour by Jianrong Zhang, Yu Huang, Hengrui Liang, Wenhua Liang, Jianxing He, Yiyin Zhang, Jiaxi He, Jieyu Wu, Long Jiang, Shiyan Tang, Qihua He, Lindsey Tristine Hamblin, Zhiheng Xu, Yaoqi Chen, Difei Chen, Xinyu Wang, Kexin Deng, Shuhan Jiang, Jiaqing Zhou, Jiaxuan Xu, Xuanzuo Chen

“…Objective Unbiased assessment of tumour response is crucial in randomised controlled trials (RCTs). Blinded independent central review is usually used as a supplemental or monitor to local assessment but is costly. …”
Get full text