Articles

Effects of novel diabetic therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration: study protocol for an open-label, randomized, controlled trial

Recurrence after the healing of a foot ulcer is very common among patients with diabetes mellitus. Novel diabetic therapeutic footwear consisted of merino wool, vibration chip, and orthopedic insoles is design...

Authors: Yun Gao, Chun Wang, Dawei Chen, Hui Huang, Lihong Chen, Guanjian Liu, Shuang Lin, Min Liu, Xiaorong Wen, Jae-Hoon Cho, Yong Chen, Yingzhu Li and Xingwu Ran

Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial

Accumulating evidence suggests that the metabolic effects of metformin and fermentable fibers are mediated, in part, through diverging or overlapping effects on the composition and metabolic functions of the g...

Authors: Edward C. Deehan, Eloisa Colin-Ramirez, Lucila Triador, Karen L. Madsen, Carla M. Prado, Catherine J. Field, Geoff D. C. Ball, Qiming Tan, Camila Orsso, Irina Dinu, Mohammadreza Pakseresht, Daniela Rubin, Arya M. Sharma, Hein Tun, Jens Walter, Christopher B. Newgard…

Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial

Russia has a high prevalence of human immunodeficiency virus (HIV) infections. In 2018, over one million persons were living with HIV (PLWH); over a third were women. A high proportion of HIV-infected women ar...

Authors: Ralph J. DiClemente, Jennifer L. Brown, Ariadna Capasso, Natalia Revzina, Jessica M. Sales, Ekaterina Boeva, Lyudmila V. Gutova, Nadia B. Khalezova, Nikolay Belyakov and Vadim Rassokhin

Correction to: The NYCKidSeq project: study protocol for a randomized controlled trial incorporating genomics into the clinical care of diverse New York City children

An amendment to this paper has been published and can be accessed via the original article.

Authors: Jacqueline A. Odgis, Katie M. Gallagher, Sabrina A. Suckiel, Katherine E. Donohue, Michelle A. Ramos, Nicole R. Kelly, Gabrielle Bertier, Christina Blackburn, Kaitlyn Brown, Lena Fielding, Jessenia Lopez, Karla Lopez Aguiniga, Estefany Maria, Jessica E. Rodriguez, Monisha Sebastin, Nehama Teitelman…

Correction to: Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system—lessons learned and recommendations

An amendment to this paper has been published and can be accessed via the original article.

Authors:

How effective are three methods of teaching oral hygiene for adolescents undergoing orthodontic treatment? The MAHO protocol: an RCT comparing visual, auditory and kinesthetic methods

Fixed orthodontic appliances hamper oral hygiene procedures. The consequences are gingivitis and white spot lesions. Fifty to 70% of patients treated with braces encounter these problems. Their care in the USA...

Authors: Alisée Le Fouler, Sylvie Jeanne, Olivier Sorel and Damien Brézulier

Ethical care requires pragmatic care research to guide medical practice under uncertainty

The current research-care separation was introduced to protect patients from explanatory studies designed to gain knowledge for future patients. Care trials are all-inclusive pragmatic trials integrated into m...

Authors: Tim E. Darsaut and Jean Raymond

Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development: a randomised trial

The Delphi method is used in a wide variety of settings as a method of building consensus on important issues. Traditionally, the Delphi method uses multiple rounds of a survey to allow for feedback of other p...

Authors: Fiona A. Quirke, Patricia Healy, Elaine Ní Bhraonáin, Mandy Daly, Linda Biesty, Tim Hurley, Karen Walker, Shireen Meher, David M. Haas, Frank H. Bloomfield, Jamie J. Kirkham, Eleanor J. Molloy and Declan Devane

MR CLEAN-NO IV: intravenous treatment followed by endovascular treatment versus direct endovascular treatment for acute ischemic stroke caused by a proximal intracranial occlusion—study protocol for a randomized clinical trial

Endovascular treatment (EVT) has greatly improved the prognosis of acute ischemic stroke (AIS) patients with a proximal intracranial large vessel occlusion (LVO) of the anterior circulation. Currently, there i...

Authors: Kilian M. Treurniet, Natalie E. LeCouffe, Manon Kappelhof, Bart J. Emmer, Adriaan C. G. M. van Es, Jelis Boiten, Geert J. Lycklama, Koos Keizer, Lonneke S. F. Yo, Hester F. Lingsma, Wim H. van Zwam, Inger de Ridder, Robert J. van Oostenbrugge, Aad van der Lugt, Diederik W. J. Dippel, Jonathan M. Coutinho…

Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial

High-normal blood pressure (BP) is associated with increased all-cause, cardiovascular mortality and frequently progresses to hypertension. Transcutaneous electrical acupoint stimulation (TEAS) might be a non-...

Authors: Yu Wang, Guang-Xia Shi, Zhong-Xue Tian, Jun-Hong Liu, You-Sheng Qi, Jian-Feng Tu, Jing-Wen Yang, Li-Qiong Wang and Cun-Zhi Liu

Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial

Multiple sclerosis is a chronic inflammatory, degenerative disease of the central nervous system manifesting at first with relapses in about 85% of cases. In Germany, intravenous therapy with high-dose cortico...

Authors: Anne Christin Rahn, Lisa Wenzel, Andrea Icks, Alexander Stahmann, Jutta Scheiderbauer, Kristina Grentzenberg, Markus Vomhof, Joseph Montalbo, Tim Friede, Christoph Heesen and Sascha Köpke

The effect of lifestyle and risk factor modification on occlusive peripheral arterial disease outcomes: standard healthcare vs structured programme—for a randomised controlled trial protocol

Peripheral arterial disease (PAD) affects more than 200 million of the global population. PAD represents a marker for premature cardiovascular events. Patients with PAD, even in the absence of a history of myo...

Authors: M. Elfghi, F. Jordan, D. Dunne, I. Gibson, J. Jones, G. Flaherty, S. Sultan and W. Tawfick

Comparative study of the effect of neuromuscular electrical stimulation and oral administration of branched-chain amino acid on preventing sarcopenia in patients after living-donor liver transplantation: study protocol for an open-label randomized controlled trial

Liver cirrhosis is the irreversible fibrosis of the liver and causes refractory ascites and hepatic encephalopathy, which might not respond to treatment. Living donor liver transplantation (LDLT) is an effecti...

Authors: Masafumi Haraguchi, Kunihiro Ichinose, Hisamitsu Miyaaki, Masatoshi Hanada, Masanori Fukushima, Ryu Sasaki, Satoshi Miuma, Takanobu Hara, Tota Kugiyama, Akihiko Soyama, Masaaki Hidaka, Ayumi Tsuji, Rintaro Yano, Motohiro Sekino, Hideaki Takahata, Susumu Eguchi…

Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study)

Transurethral resection of bladder tumor (TURBT) is an essential procedure both for the treatment and staging of bladder cancer, particularly non-muscle invasive bladder cancer (NMIBC). The dissemination of ca...

Authors: Makito Miyake, Nobutaka Nishimura, Takashi Inoue, Shota Suzuki, Tomomi Fujii, Takuya Owari, Shunta Hori, Yasushi Nakai, Michihiro Toritsuka, Hitoshi Nakagawa, Shinji Tsukamoto, Satoshi Anai, Kazumasa Torimoto, Tatsuo Yoneda, Nobumichi Tanaka and Kiyohide Fujimoto

Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial

Postprandial distress syndrome manifests as a feeling of fullness and early satiation that can significantly reduce the quality of life of the patients. In Chinese medicine (CM), the syndrome is traditionally ...

Authors: Sai Ho Sin, Jing Wu, Yuchen Kang, Kar Hung Kevin Yip, Ngo Suet Kong, Hei Wan, Bacon Fung Leung Ng and Haiyong Chen

Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial

Following surgery for soft tissue sarcoma of the retroperitoneum, the predominant pattern of failure is local recurrence, which remains the main cause of death. Radiotherapy is utilized to reduce recurrence ra...

Authors: K. Seidensaal, M. Kieser, A. Hommertgen, C. Jaekel, S. B. Harrabi, K. Herfarth, G. Mechtesheimer, B. Lehner, M. Schneider, H. Nienhueser, S. Fröhling, G. Egerer, J. Debus and M. Uhl

Effect of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk: study protocol for a cluster-randomized trial

More than 50% of patients with type 2 diabetes have hypertension in Uganda. Diabetic patients with elevated systolic blood pressure experience higher all-cause mortality and cardiovascular events compared with...

Authors: William Lumu, Davis Kibirige, Ronald Wesonga and Silver Bahendeka

M.I.C.E—Mental Health Intervention for Children with Epilepsy: a randomised controlled, multi-centre clinical trial evaluating the clinical and cost-effectiveness of MATCH-ADTC in addition to usual care compared to usual care alone for children and young people with common mental health disorders and epilepsy—study protocol

Mental health disorders in the context of long-term conditions in children and young people are currently overlooked and undertreated. Evidence-based psychological treatments for common childhood mental health...

Authors: Sophie D. Bennett, J. Helen Cross, Anna E. Coughtrey, Isobel Heyman, Tamsin Ford, Bruce Chorpita, Rona Moss-Morris, Sarah Byford, Emma Dalrymple, Colin Reilly, Terence Stephenson, Caroline Doré, Sophia Varadkar, James Blackstone, Kashfia Chowdhury, Poushali Ganguli…

Impact of intravenous lidocaine on clinical outcomes of patients with ARDS during COVID-19 pandemia (LidoCovid): A structured summary of a study protocol for a randomised controlled trial

The main objective of this study is to evaluate the effect of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome due or not to Covid-19 pneumonia.

Authors: Marie Muller, François Lefebvre, Marie-Line Harlay, Ludovic Glady, Guillaume Becker, Charlotte Muller, Ouafaa Aberkane, Mira Tawk, Madoé Julians, Arnaud Romoli, Stéphane Hecketsweiler, Francis Schneider, Julien Pottecher and Thiên-Nga Chamaraux-Tran

A double blinded placebo controlled comparative clinical trial to evaluate the effectiveness of Siddha medicines, Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy treatment in the management of symptomatic COVID 19 patients - a structured summary of a study protocol for a randomized controlled trial

The primary objectives of the study are to determine the effectiveness of the Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy Treatment to compared with Placebo (Decaffeinated...

Authors: Anurag Srivastava, Manickavasagam Rengaraju, Saurabh Srivastava, Vimal Narayan, Vivek Gupta and Rashmi Upadhayay

Acceptability and feasibility of a community-based strength, balance, and Tai Chi rehabilitation program in improving physical function and balance of patients after total knee arthroplasty: study protocol for a pilot randomized controlled trial

The rate of falls in patients after total knee arthroplasty (TKA) is high and related to lower limb muscle weakness and poor balance control. However, since routine post-TKA rehabilitation is uncommon, it is p...

Authors: Cathy W. T. Lo, Matthew A. Brodie, William W. N. Tsang, Chun-Hoi Yan, Priscillia L. Lam, Chun-Ming Chan, Stephen R. Lord and Arnold Y. L. Wong

Randomized trial of community health worker-led decision coaching to promote shared decision-making for prostate cancer screening among Black male patients and their providers

Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the USA. The United States Preventive Services Task Force (USPSTF) encourages prostate-specif...

Authors: Danil V. Makarov, Zachary Feuer, Shannon Ciprut, Natalia Martinez Lopez, Angela Fagerlin, Michele Shedlin, Heather T. Gold, Huilin Li, Gina Lynch, Rueben Warren, Peter Ubel and Joseph E. Ravenell

A quadruple blinded placebo controlled randomised trial to evaluate the effectiveness of an Iodine complex for patients with mild to moderate COVID-19 in Pakistan (I-COVID-PK): A structured summary of a study protocol for a randomised controlled trial

The objective of the study is to measure the efficacy of ionic-iodine polymer complex [1] for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients.

Authors: Sohaib Ashraf, Shoaib Ashraf, Moneeb Ashraf, Muhammad Ahmad Imran, Larab Kalsoom, Uzma Nasim Siddiqui, Iqra Farooq, Muhammad Ghufran, Romaisa Arshad Khokhar, Muhammad Kiwan Akram, Iqra Shahid, Muhammad Sohaib Ur Rehman, Rutaba Akmal, Arbaz Tahir, Ayesha Zahid, Sidra Ashraf…

Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2—azithromycin trial

The rapid emergence and the high disease burden of the novel coronavirus SARS-CoV-2 have created a medical need for readily available drugs that can decrease viral replication or blunt the hyperinflammatory st...

Authors: Iwein Gyselinck, Laurens Liesenborghs, Ewout Landeloos, Ann Belmans, Geert Verbeke, Peter Verhamme, Robin Vos and W. Janssens

COHESION: core outcomes in neonatal encephalopathy (protocol)

Neonatal encephalopathy is a complex syndrome in infants that predominantly affects the brain and other organs. The leading cause is a lack of oxygen in the blood reaching the brain. Neonatal encephalopathy ca...

Authors: Fiona A. Quirke, Patricia Healy, Elaine Ní Bhraonáin, Mandy Daly, Linda Biesty, Tim Hurley, Karen Walker, Shireen Meher, David M. Haas, Frank H. Bloomfield, Jamie J. Kirkham, Eleanor J. Molloy and Declan Devane

Narrative enhancement and cognitive therapy (NECT) to improve social functioning in people with serious mental illness: study protocol for a stepped-wedge cluster randomized controlled trial

Self-stigma is highly prevalent in serious mental illness (SMI) and is associated with poorer clinical and functional outcomes. Narrative enhancement and cognitive therapy (NECT) is a group-based intervention ...

Authors: J. Dubreucq, M. Faraldo, M. Abbes, B. Ycart, H. Richard-Lepouriel, S. Favre, F. Jermann, J. Attal, M. Bakri, T. Cohen, C. Cervello, I. Chereau, C. Cognard, M. De Clercq, A. Douasbin, J. Y. Giordana…

Efficacy and safety of Shi-style cervical manipulation therapy for treating acute and subacute neck pain: study protocol for a randomized controlled trial

Neck pain is a common clinical disease, which seriously affects people’s mental health and quality of life and results in loss of social productivity. Improving neck pain’s curative effect and reducing its rec...

Authors: Mingcai Zhang, Guoqing Du, Congying Liu, Wei Li, Jiayu Yang, Bo Chen, Xiaoyue Yu, Yizhe Xiong, Enyu Jiang, Ningyang Gao, Sumin Jiang, Zhenqiu Xu, Xiang Wang and Hongsheng Zhan

Correction to: Statistical analysis plan for management of hypertension and multiple risk factors to enhance cardiovascular health in Singapore: the SingHypertension pragmatic cluster randomized controlled trial

An amendment to this paper has been published and can be accessed via the original article.

Authors: John C. Allen Jr, Benjamin Halaand, Rupesh M. Shirore and Tazeen H. Jafar

Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial

Natural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are ...

Authors: Rui Luo, Fangfang Zheng, Haobo Zhang, Weiquan Zhu, Penghui He and Dongning Liu

Transitional care from skilled nursing facilities to home: study protocol for a stepped wedge cluster randomized trial

Skilled nursing facility (SNF) patients are medically complex with multiple, advanced chronic conditions. They are dependent on caregivers and have experienced recent acute illnesses. Among SNF patients, the r...

Authors: M. Toles, C. Colón-Emeric, L. C. Hanson, M. Naylor, M. Weinberger, J. Covington and J. S. Preisser

Using ActionADE to create information continuity to reduce re-exposures to harmful medications: study protocol for a randomized controlled trial

Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information c...

Authors: Jeffrey P. Hau, Penelope M. A. Brasher, Amber Cragg, Serena Small, Maeve Wickham and Corinne M. Hohl

Effects of different wavelengths of invasive laser acupuncture on chronic non-specific low back pain: a study protocol for a pilot randomized controlled trial

Chronic non-specific low back pain (CLBP) is a common musculoskeletal disorder for which patients seek complementary and alternative medical treatments, including laser acupuncture (LA). Invasive LA (ILA) invo...

Authors: Jae-Hong Kim, Chang-Su Na, Gwang-Cheon Park and Jeong-Soon Lee

Remote data collection during COVID-19 restrictions: an example from a refugee and asylum-seeker participant group in the UK

This article describes how one trial site of the Refugee Emergency: Defining and Implementing Novel Evidence-based psychosocial interventions (RE-DEFINE) study, designed to evaluate a Self Help+ intervention w...

Authors: Lauren Walker, Della Bailey, Rachel Churchill and Emily Peckham

A Phase I/II Clinical Trial to evaluate the efficacy of baricitinib to prevent respiratory insufficiency progression in onco-hematological patients affected with COVID19: A structured summary of a study protocol for a randomised controlled trial

Baricitinib is supposed to have a double effect on SARS-CoV2 infection. Firstly, it reduces the inflammatory response through the inhibition of the Januse-Kinase signalling transducer and activator of transcri...

Authors: G. Moreno-González, A. Mussetti, A. Albasanz-Puig, I. Salvador, A. Sureda, C. Gudiol, R. Salazar, M. Marin, M. Garcia, V. Navarro, I. de la Haba Vaca, E. Coma, G. Sanz-Linares, X. Dura, S. Fontanals, G. Serrano…

Management of Renin-Angiotensin-Aldosterone System blockade in patients admitted to hospital with confirmed coronavirus disease (COVID-19) infection (The McGill RAAS-COVID- 19): A structured summary of a study protocol for a randomized controlled trial

The aim of the RAAS-COVID-19 randomized control trial is to evaluate whether an upfront strategy of temporary discontinuation of renin angiotensin aldosterone system (RAAS) inhibition versus continuation of RA...

Authors: Mona Aflaki, Alexandria Flannery, João Pedro Ferreira, Matthew Pellan Cheng, Nadine Kronfli, Ariane Marelli, Faiez Zannad, James Brophy, Jon Afillalo, Thao Huynh, Nadia Giannetti, Amal Bessissow, Justin A. Ezekowitz, Renato D. Lopes, Andrew P. Ambrosy, Morgan Craig…

Barriers impacting the POINT pragmatic trial: the unavoidable overlap between research and intervention procedures in “real-world” research

This manuscript provides a research update to the ongoing pragmatic trial of Project POINT (Planned Outreach, Intervention, Naloxone, and Treatment), an emergency department-based peer recovery coaching interv...

Authors: Allyson L. Dir, Dennis P. Watson, Matthew Zhiss, Lisa Taylor, Bethany C. Bray and Alan McGuire

Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy—the MILO Study

Post-term pregnancy is associated with an increased risk of maternal complications, respiratory distress and trauma to the neonate. Amniotic membrane sweeping has been recommended as a simple procedure to prom...

Authors: Elaine M. Finucane, Linda Biesty, Deirdre Murphy, Amanda Cotter, Eleanor Molloy, Martin O’Donnell, Shaun Treweek, Paddy Gillespie, Marian Campbell, John J. Morrison, Alberto Alvarez-Iglesias, Gill Gyte and Declan Devane

Convalescent plasma therapy for COVID-19 patients: a protocol of a prospective meta-analysis of randomized controlled trials

Coronavirus disease 2019 (COVID-19) is an infection with possible serious consequences. The plasma of recovered patients might serve as treatment, which we aim to assess in the form of a prospective meta-analy...

Authors: Lajos Szakó, Nelli Farkas, Szabolcs Kiss, Szilárd Váncsa, Noémi Zádori, Nóra Vörhendi, Bálint Erőss, Péter Hegyi and Hussain Alizadeh

High-dose vitamin D versus placebo to prevent complications in COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial (CARED-TRIAL)

To evaluate whether a single high dose of oral cholecalciferol improves the respiratory outcomes as compared with placebo among adults COVID-19 patients at moderate risk of clinical complications.

Authors: Javier Mariani, Carlos Tajer, Laura Antonietti, Felipe Inserra, León Ferder and Walter Manucha

Naltrexone treatment for prolonged grief disorder: study protocol for a randomized, triple-blinded, placebo-controlled trial

There is a lack of effective pharmacotherapy for prolonged grief disorder (PGD). Evidence suggests that the neurobiology of PGD involves the same circuitry as the reward pathway. Based upon this evidence, we h...

Authors: James Gang, James Kocsis, Jonathan Avery, Paul K. Maciejewski and Holly G. Prigerson

Homeopathy for Covid-19 in Primary Care: A structured summary of a study protocol for a randomized controlled trial

To investigate the effectiveness and safety of homeopathic medicine Natrum muriaticum (LM2) for mild cases of COVID-19 in Primary Health Care.

Authors: Ubiratan Cardinalli Adler, Maristela Schiabel Adler, Livia Mitchiguian Hotta, Ana Elisa Madureira Padula, Amarilys de Toledo Cesar, José Nelson Martins Diniz, Crislaine Aparecida Antonio Mestre, Katia Regina Spiller, Lidiamara Soares, Helen de Freitas Santos and Edson Zangiacomi Martinez

Low-carbohydrate dietary pattern on glycemic outcomes trial (ADEPT) among individuals with elevated hemoglobin A1c: study protocol for a randomized controlled trial

Type 2 diabetes mellitus (T2DM) is a major cause of morbidity and mortality globally. Strong evidence supports the importance of diet and other lifestyle factors in preventing T2DM. Among individuals with T2DM...

Authors: Kirsten S. Dorans, Lydia A. Bazzano, Lu Qi, Hua He, Lawrence J. Appel, Jonathan M. Samet, Jing Chen, Katherine T. Mills, Bernadette T. Nguyen, Matthew J. O’Brien, Gabriel I. Uwaifo and Jiang He

Effect of physical exercise in bariatric surgery patients: protocol of a randomized controlled clinical trial

Bariatric surgery is an effective approach to weight loss and long-term comorbidity resolution. Although recommended in several guidelines, supervised exercise has not been systematically prescribed after bari...

Authors: Andrea Herrera-Santelices, Andrea Tabach-Apraiz, Karen Andaur-Cáceres and Antonio Roberto Zamunér

The effectiveness of Tai Chi on the depressive symptom of young adults with subthreshold depression: a study protocol for a randomized controlled trial

Depression is seriously affecting the physical and mental health of young people worldwide. Subthreshold depression, as an early stage of depression, is essential for early prevention and treatment of depressi...

Authors: Xiaoting Xie, Jian Song, Jingfang Zhu, Mengyu Han, Youze He, Jia Huang, Jing Tao and Jingsong Wu

Bioavailable turmeric extract for knee osteoarthritis: a randomized, non-inferiority trial versus paracetamol

To compare the efficacy and safety of bioavailable turmeric extract versus paracetamol in patients with knee osteoarthritis (OA).

Authors: Shubha Singhal, Nazer Hasan, Kirti Nirmal, Rohit Chawla, Shalini Chawla, Bhupinder Singh Kalra and Anil Dhal

Augmentation of EMDR with multifocal transcranial current stimulation (MtCS) in the treatment of fibromyalgia: study protocol of a double-blind randomized controlled exploratory and pragmatic trial

Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2.7% of the general population. In recent years, different studies have observed a strong association between FM and psychological...

Authors: I. Gardoki-Souto, O. Martín de la Torre, B. Hogg, D. Redolar-Ripoll, A. Valiente-Gómez, L. Martínez Sadurní, J. M. Blanch, W. Lupo, V. Pérez, J. Radua, B. L. Amann and A. Moreno-Alcázar

Letter to the Editor: Problems with studying community-level pesticide storage to prevent suicide

Authors: Aastha Sethi and Michael Eddleston

Core outcomes set for research on the treatment of opioid use disorder (COS-OUD): the National Institute on Drug Abuse Clinical Trials Network protocol for an e-Delphi consensus study

A lack of consensus on the optimal outcome measures to assess the efficacy and effectiveness of interventions for the treatment of opioid use disorder (OUD) has hampered the pooling of research data for eviden...

Authors: Niranjan S. Karnik, Cynthia I. Campbell, Megan E. Curtis, David A. Fiellin, Udi Ghitza, Kathryn Hefner, Yih-Ing Hser, R. Kathryn McHugh, Sean M. Murphy, Sterling M. McPherson, Landhing Moran, Larissa J. Mooney, Li-Tzy Wu, Dikla Shmueli-Blumberg, Matisyahu Shulman, Robert P. Schwartz…

Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system—lessons learned and recommendations

The Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial is a global adaptive platform trial of hospitalized patients with COVID-19. We describe implementation at the first US ...

Authors:

Effects of controlled hypotension with restrictive transfusion on intraoperative blood loss and systemic oxygen metabolism in elderly patients who underwent lumbar fusion

The effects of restrictive fluid therapy combined with controlled hypotension in the elderly on systemic oxygen metabolism and renal function are clinical concerns. The aim of this study was to evaluate blood ...

Authors: Xiaodong Qiu, Zhiying Tan, Wenhao Tang, Hui Ye and Xinjian Lu