clinical trials

Managing Unusual Sensory Experiences in People with First-Episode Psychosis (MUSE FEP): a study protocol for a single-blind parallel-group randomised controlled feasibility trial
Robert Dudley, Guy Dodgson, Stephanie Common, Lucy O’Grady, Florence Watson, Christopher Gibbs, Bronia Arnott, Charles Fernyhough, Ben Alderson-Day, Emmanuel Ogundimu, Ehsan Kharatikoopaei, Victoria Patton, Charlotte Aynsworth

BMJ Open May 2022, 12 (5) e061827; DOI: 10.1136/bmjopen-2022-061827
Treatment of unresectable locally advanced pancreatic cancer with percutaneous irreversible electroporation (IRE) following initial systemic chemotherapy (LAP-PIE) trial: study protocol for a feasibility randomised controlled trial
Zainab L Rai, Veronica Ranieri, Daniel H Palmer, Peter Littler, Pauleh Ghaneh, Kurinchi Gurusamy, Derek Manas, Elena Pizzo, Eftychia Eirini Psarelli, Roopinder Gilmore, Praveen Peddu, David C Bartlett, Nicola de Liguori Carino, Brian R Davidson

BMJ Open May 2022, 12 (5) e050166; DOI: 10.1136/bmjopen-2021-050166
Personalised immunotherapy in sepsis: a scoping review protocol
Marleen A Slim, Niels van Mourik, Joanna C Dionne, Simon J W Oczkowski, M G Netea, Peter Pickkers, Evangelos J Giamarellos-Bourboulis, Marcella C A Müller, Tom van der Poll, W Joost Wiersinga, Alexander P J Vlaar, Lonneke A van Vught

BMJ Open May 2022, 12 (5) e060411; DOI: 10.1136/bmjopen-2021-060411
Effects of maternal docosahexaenoic acid supplementation on brain development and neurodevelopmental outcomes of breastfed preterm neonates: protocol for a follow-up at preschool age of a randomised clinical trial (MOBYDIckPS)
Mireille Guillot, Carole-Anne Robitaille, Laurence Turner, Etienne Pronovost, Georges Caouette, Célia Matte-Gagné, François Olivier, Julie Bartholomew, Édith Massé, Alyssa Morin, Ibrahim Mohamed, Isabelle Marc

BMJ Open May 2022, 12 (5) e057482; DOI: 10.1136/bmjopen-2021-057482
Effects of temporarily suspending low-dose methotrexate treatment for 2 weeks after SARS-CoV-2 vaccine booster on vaccine response in immunosuppressed adults with inflammatory conditions: protocol for a multicentre randomised controlled trial and nested mechanistic substudy (Vaccine Response On/Off Methotrexate (VROOM) study)
Abhishek Abhishek, RJ Boyton, Áine McKnight, Laura Coates, James Bluett, Vicki S Barber, Lucy Cureton, Anne Francis, Duncan Appelbe, Lucy Eldridge, Patrick Julier, Nicholas Peckham, Ana M Valdes, Ines Rombach, Daniel M Altmann, Jonathan Nguyen-Van-Tam, Hywel C Williams, Jonathan Alistair Cook

BMJ Open May 2022, 12 (5) e062599; DOI: 10.1136/bmjopen-2022-062599
Randomised double-blind phase 3 clinical study testing impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy: study protocol
Aino Siltari, Jarno Riikonen, Juha Koskimäki, Tomi Pakarainen, Otto Ettala, Peter Boström, Heikki Seikkula, Andres Kotsar, Teuvo Tammela, Mika Helminen, Paavo V Raittinen, Terho Lehtimäki, Mikkel Fode, Peter Østergren, Michael Borre, Antti Rannikko, Timo Marttila, Arto Salonen, Hanna Ronkainen, Sven Löffeler, Teemu J Murtola

BMJ Open Apr 2022, 12 (4) e050264; DOI: 10.1136/bmjopen-2021-050264
Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery
Salma Shickh, Daena Hirjikaka, Marc Clausen, Rita Kodida, Chloe Mighton, Emma Reble, Jordan Sam, Seema Panchal, Melyssa Aronson, Tracy Graham, Susan Randall Armel, Emily Glogowski, Christine Elser, Andrea Eisen, June C Carroll, Cheryl Shuman, Emily Seto, Nancy N Baxter, Adena Scheer, Serena Shastri-Estrada, Geoff Feldman, Kevin E Thorpe, Kasmintan A Schrader, Jordan Lerner-Ellis, Raymond H Kim, Hanna Faghfoury, Yvonne Bombard

BMJ Open Apr 2022, 12 (4) e060899; DOI: 10.1136/bmjopen-2022-060899
Using routine healthcare data to evaluate the impact of the Medicines at Transitions Intervention (MaTI) on clinical outcomes of patients hospitalised with heart failure: protocol for the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) cluster randomised controlled trial with embedded process evaluation, health economics evaluation and internal pilot
Lauren A Moreau, Ivana Holloway, Beth Fylan, Suzanne Hartley, Bonnie Cundill, Alison Fergusson, Sarah Alderson, David Phillip Alldred, Chris Bojke, Liz Breen, Hanif Ismail, Peter Gardner, Ellen Mason, Catherine Powell, Jonathan Silcock, Andrew Taylor, Amanda Farrin, Chris Gale

BMJ Open Apr 2022, 12 (4) e054274; DOI: 10.1136/bmjopen-2021-054274
A Phase II trial of Higher RadiOtherapy Dose In The Eradication of early rectal cancer (APHRODITE): protocol for a multicentre, open-label randomised controlled trial
Eleanor M Hudson, Samantha Noutch, Sarah Brown, Ravi Adapala, Simon P Bach, Carole Burnett, Alwyn Burrage, Alexandra Gilbert, Maria Hawkins, Debra Howard, Monica Jefford, Rohit Kochhar, Mark Saunders, Jenny Seligmann, Alexandra Smith, Mark Teo, Edward JD Webb, Amanda Webster, Nicholas West, David Sebag-Montefiore, Simon Gollins, Ane L Appelt

BMJ Open Apr 2022, 12 (4) e049119; DOI: 10.1136/bmjopen-2021-049119
Supervised physical activity in patients with symptomatic peripheral arterial disease: protocol for a randomized clinical trial (ARTPERfit Study)
Maria Teresa Alzamora, Rosa Forés, Noemi Serra, Esau Martinez, Guillem Pera, Gemma Seda, Joan Lopez Palencia, Manuel Gomis, Antonio Heras Tébar, Marta Valverde, Manuel Vicente Garnacho, Pere Torán

BMJ Open Apr 2022, 12 (4) e054352; DOI: 10.1136/bmjopen-2021-054352

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