The Impact of Chronic Pelvic Pain and Bowel Morbidity on Quality of Life in Cervical Cancer Patients Treated With Radio (Chemo) Therapy. A Systematic Literature Review by Natuhwera G, Ellis P

“…Data were extracted using a structured checklist designed to capture key elements about the methods and findings of the research.Results: There were 245 articles retrieved with 29 meeting the inclusion criteria. 11 studies were conducted in Europe, eight in Asia, one in North America, three in Africa, while six were multinational/multicontinental. 13 of the papers were longitudinal, 10 cross-sectional, three literature reviews, one open randomised controlled trial, and two retrospective studies of prospectively collected data. …”
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Cognitive behavioural therapy plus Kiesler Circle Training (CBT+) versus CBT only for patients with interpersonal problems: study protocol for a randomised controlled feasibility t... by Stephan Köhler, Philipp Sterzer, Eva-Lotta Brakemeier, Karen Ollrogge, Daniel Schulze, Eva Friedel, Nina Romanczuk-Seiferth, Anna-Lena Siegerist, Anne Guhn

“…This study aims to evaluate the efficacy and feasibility of a transdiagnostic group intervention, the Kiesler Circle Training (KCT), in improving interpersonal skills.Methods and analysis In a prospective randomised controlled trial (RCT), 156 outpatients with a primary diagnosis of either depression or anxiety disorder according to DSM-5, and significant interpersonal problems, will be investigated. …”
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Refreshing medical students’ intravenous-cannulation skills: a blinded observer three-arm randomised comparison of mental imagery, part-task trainer simulation and written instruct... by Robert Greif, Joana Berger-Estilita, Rafael Blülle, Daniel Stricker, Mathias Balmer, Christoph Berendonk

“…This study investigates the effectiveness of three educational strategies used to refresh the intravenous cannulation skills of first-year medical students: mental imagery, part-task trainer simulation and written instructions.Materials and methods In this single-centre randomised controlled trial, first-year medical students were assigned to one of three different refresher tutorials on intravenous cannulation. …”
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Experiences of Māori and Pacific women recruited into a pregnancy clinical trial in Aotearoa, New Zealand: a Kaupapa Māori qualitative study by Matire Harwood, Benjamin B Albert, Rachel Roskvist, Jamie-Lee Rahiri, Richard Enright, Tania Mullane, Vidit Vinod Satokar

“…In contrast, the major barriers described were time pressures and the distance to the research facility.Conclusions Sixteen Māori and Pacific women who participated in a double-blinded randomised controlled trial shared that successful recruitment of Māori and Pacific women into clinical trials can be promoted by research flexibility participants’ whānau/family responsibilities, effective and culturally safe communication, and research teams striving to build and maintain relationships with participants throughout the trial.Trial registeration number Australian New Zealand Clinical Trials Registry, ACTRN12617001078347p. …”
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Efficacy and safety of rivaroxaban in preventing venous thromboembolism in postoperative patients with gynecological malignancies: protocol for a randomised controlled open-label t... by Hong Zhou, Fei He, Ting Wei, Shuyi Wu, Jinhua Zhang, Huan Yi

“…The proposed randomised controlled trial (RCT) aims to compare the efficacy and safety of rivaroxaban and enoxaparin in preventing VTE in patients after surgery for gynaecological malignancies and to provide a reference for clinical medication prevention.Methods and analysis This is a single-centre, randomised, controlled, open-label and assessor-blind clinical trial. …”
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Randomised feasibility study of an intestinal adsorbent in acute diarrhoea in The Gambia by Elena Markaryan, Matthew Dodd, Stephen Allen, Carol Howell, Angela Allen, Paul Rahden, Abdoulie Fatty, Momodou Lamin Jobarteh, Abdoulwahab Sallah, Ebrahim Jaiteh, Doreen Umoh, Fanta Bass, Radovan Hnatič

“…One serious event (death) occurred in the control arm.Conclusions A randomised, controlled trial is feasible. Further clinical trials are warranted to confirm the efficacy of polymethylsiloxane polyhydrate in acute diarrhoea and inform management guidelines.Trial registration number PACTR202302683128875.…”
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The Effectiveness of Acupuncture on Myofascial Trigger Points Versus Traditional Chinese Medicine Acupoints for Treating Plantar Fasciitis With Low Back Pain: A Study Protocol for... by Huang Z, Liang X, Luo Y, Fang Z, Xu M, Xu Y, Cheng S, Li L

“…This trial aims to compare the effectiveness of acupuncture at trigger points versus Traditional Chinese Medicine (TCM) acupoints in the treatment of participants with plantar fasciitis and low back pain.Methods: The trial will be a single-centre, parallel two-group, randomised controlled trial with 62 participants allocated in a 1:1 ratio to either the trigger point group or the TCM acupoint group. …”
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Heavy slow resistance training, radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the Norwegian secondary care: a randomised controlled feasibili... by Jens Ivar Brox, Marianne Bakke Johnsen, Cecilie Roe, Aasne Fenne Hoksrud, Håkon Sveinall, Kaia B Engebretsen

“…Shock wave therapy and information and advice should be investigated further in a full-scale randomised controlled trial including sham shock wave therapy.Trial registration number NCT04803825.…”
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Sequential exploratory mixed-method research of an eHealth intervention on blood pressure, sleep quality and physical activity in obstructive sleep apnoea: rationale and methodolog... by Manuel Sánchez-de-la-Torre, Ferran Barbé, Oriol Martínez-Navarro, Francisco José Verdejo-Amengual, Fran Valenzuela-Pascual, Joan Blanco-Blanco, Rabie Adel El Arab, Esther Rubinat-Arnaldo, Maria Masbernat-Almenara, Francesc Rubí‑Carnacea, Blanca Manuel Martí

“…The quantitative phase will be a triple-blind randomised controlled trial. The experimental group (n=135) will receive an eHealth intervention using an electronic wrist device and a mobile application that will offer specific healthcare recommendations, physical activity indications and hygienic and dietary advice. …”
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Structured follow-up pathway to support people after transient ischaemic attack and minor stroke (SUPPORT TIA): protocol for a feasibility study and process evaluation by Grace M Turner, Melanie Calvert, Sue Jowett, Robbie Foy, Jonathan Mant, Sarah Tearne, Lou Atkins, Rachael Jones, Smitaa Patel, Phillip Collis

“…The study aims to assess the feasibility and acceptability of (1) the intervention and (2) the trial procedures for a future randomised controlled trial of this intervention.Methods and analysis This is a multicentre, randomised (1:1) feasibility study with a mixed-methods process evaluation. …”
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Procedural sedative effect of remimazolam in ICU patients on invasive mechanical ventilation: a randomised, prospective study by Youli Tian, Jintong Li, Minggen Jin, YiHua Piao, Jisheng Sheng, Zhixiong Mei, Qingsong Cui, Lilin Li

“…Methods In this single-centre randomised controlled trial, intubated patients were randomly assigned to the remimazolam group or the propofol group. …”
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Action Imagery and Observation in Neurorehabilitation for Parkinson’s Disease (ACTION-PD): Development of a User-Informed Home Training Intervention to Improve Functional Hand Move... by Judith Bek, Paul S. Holmes, Chesney E. Craig, Zoë C. Franklin, Matthew Sullivan, Jordan Webb, Trevor J. Crawford, Stefan Vogt, Emma Gowen, Ellen Poliakoff

“…Preliminary data on feasibility were obtained via a six-week pilot randomised controlled trial (ISRCTN 11184024) of 10 participants with mild to moderate PD (6 intervention; 4 treatment as usual). …”
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Cross-agency working when conducting a pragmatic RCT for older victims of crime: our experiences and lessons learned by Marc Serfaty, Jessica Satchell, Gloria K. Laycock, Chris R. Brewin, Marta Buszewicz, Gerard Leavey, Vari M. Drennan, Jonathan Cooke, Anthony Kessel

“…Our recent Victim Improvement Package (VIP) randomised controlled trial (RCT) involved cross-agency collaboration between our university, a police service and a mental health charity. …”
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Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedi... by Marie C. Hyslop, Diana E. Papaioannou, Robert Bolt, Matthew J. Wilson, Michael Bradburn, Janet Clarkson, Esther Herbert, Nicholas Ireland, Jennifer Kettle, Amanda Loban, Amy C. Norrington, Christopher Vernazza, Christopher Deery

“…Background: Poor recruitment is one key reason for premature closure of randomised controlled trials. The Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial was a multicentre randomised controlled trial of melatonin vs midazolam in the premedication of anxious children, before surgery. …”
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Symptom patterns in patients newly sick listed for common mental disorders and associations with work-related and socioeconomic factors: a cross-sectional study in Swedish primary... by Cecilia Björkelund, Dominique Hange, Eva-Lisa Petersson, Irene Svenningsson, Nashmil Ariai, Lilian Wiegner

“…Objective The aim was to determine symptom patterns of depression, anxiety and stress-related mental disorders in newly sick listed due to common mental disorders in Swedish primary care patients and to examine associations with sick leave diagnosis, also in relation to socioeconomic, work-related and demographic factors.Design Cross-sectional study.Setting Primary care in western Sweden.Participants From a randomised controlled trial, patients aged 18–67, seeking primary care and on sick leave due to depression, anxiety and/or mental stress, in total 341 individuals, during 2018–2020.Primary outcome measures Patterns of depressive, anxiety and stress symptoms measured via self-assessment questionnaires (Montgomery Asberg Depression Rating Scale-Self (MADRS-S), General Anxiety Disorder Scale-7 (GAD-7), Karolinska Exhaustion Disorder Scale (KEDS)), sick leave diagnosis, perception of Work Ability Index and job strain via the job strain model.Results A combination of high levels of depressive and stress-related symptoms was more frequent than single symptom clusters among persons with common mental disorders (CMD) on sick leave: 7% of the patients had scores above cut-off for one of the instruments MADRS-S, GAD-7 and KEDS, 12% above cut-off for two and 80% had above cut-off for all three instruments. …”
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Enhancing resilience: the impact of a near-peer mentoring program on medical students by Lea Pölczman, Lea Pölczman, Dorottya Árva, Dorottya Árva, Zsuzsa Győrffy, Márk Jámbor, András Végh, András Végh, Gergő Kristóf, György Purebl, Edmond Girasek

“…This study measured the effectiveness of a near-peer mentoring program in terms of resilience.MethodsA non-randomised controlled trial was conducted at Semmelweis University involving 133 medical students. …”
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Assessing the use of geospatial data for immunization program implementation and associated effects on coverage and equity in the Democratic Republic of Congo by Dosithée Ngo-Bebe, Patricia Mechael, Fulbert Nappa Kwilu, Théophane Kekemb Bukele, Félicité Langwana, Genèse Lolimo Lobukulu, Marcelo Ilunga Kalonji, Bahindwa Kalalizi, Kevin Tschirhart, Christophe Lungayo Luhata, Carine Gachen

“…Trial registration The study was registered and given BMC Central International Standard. Randomised Controlled Trial Number ISRCTN65876428 on March 11, 2021.…”
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Evaluation of two electronic-rehabilitation programmes for persistent knee pain: protocol for a randomised feasibility trial by Philip G Conaghan, Kim L Bennell, Mark Conner, Rana S Hinman, Sarah R Kingsbury, Elizabeth M A Hensor, Gretl A McHugh, Christine Comer, Dawn Groves-Williams, Rachel K Nelligan

“…If considered feasible and acceptable, a definitive randomised controlled trial can be conducted to investigate the clinical effectiveness and cost-effectiveness of one or both interventions with a view to implementation in routine care.Ethics and dissemination The trial was approved by the West of Scotland Research Ethics Committee 5 (Reference: 20/WS/0006). …”
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Efficacy, efficiency and safety of a cardiac telerehabilitation programme using wearable sensors in patients with coronary heart disease: the TELEWEAR-CR study protocol by Andrew Xanthopoulos, Eleni Kapreli, Garyfallia Pepera, Konstantinos I Gourgoulianis, Varsamo Antoniou, Gregory Giamouzis, Constantinos Davos, Ladislav Batalik, Vasileios Stavrou, John Skoularigis

“…This study will investigate the efficacy, efficiency, safety and cost-effectiveness of a telerehabilitation programme based on objective exercise telemonitoring and evaluation of cardiorespiratory fitness.Methods and analysis A supervised, parallel-group, single-blind randomised controlled trial will be conducted. A total of 124 patients with coronary disease will be randomised in a 1:1 ratio into two groups: intervention telerehabilitation group (TELE-CR) (n=62) and control centre-based cardiac rehabilitation group (CB-CR) (n=62). …”
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Protocol of a randomised controlled phase II clinical trial investigating PREoperative endoscopic injection of BOTulinum toxin into the sphincter of Oddi to reduce postoperative pa... by Phillip Knebel, Thilo Hackert, Markus W Büchler, Thomas Bruckner, Peter Sauer, Markus K Diener, Christine Tjaden, Ulla Klaiber, Pascal Probst, Eike Martin, Steffen Luntz

“…The aim of this project (PREBOTPilot) is to generate the first randomised controlled trial data on the safety, feasibility and efficacy of preoperative endoscopic BTX injection into the sphincter of Oddi to prevent clinically relevant POPF following DP.Methods and analysis PREBOTPilot is an investigator-initiated, single-centre, randomised, controlled, open-label, phase II clinical trial with two parallel study groups and an exploratory study design. 60 patients scheduled for DP will be randomised to intervention and control group. …”
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