Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial
DiscussionThis trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient ’s opinion about their knee and associated problems when suffering from osteoarthritis. (Source: Trials)
Source: Trials - October 27, 2021 Category: Research Source Type: clinical trials

Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial
DiscussionOur trial is unique in its design in that it aims to introduce an operationalized structured clinical pathway aimed to reduce polypharmacy in a primary care setting while at the same time recording patient ’s goals and priorities for treatment.Trial registrationClinicalTrials.gov NCT02942927. First registered on October 24, 2016. (Source: Trials)
Source: Trials - October 26, 2021 Category: Research Source Type: clinical trials

Recovering arm function in chronic stroke patients using combined anodal HD-tDCS and virtual reality therapy (ReArm): a study protocol for a randomized controlled trial
The objective of the project will be to evaluate the impact of adding anodal high-definition (HD)-tDCS during an intensive 3-week UL VRT and conventional therapy program on paretic UL function in chronic stroke.MethodsThe ReArm project is a quadruple-blinded, randomized, sham-controlled, bi-centre, two-arm parallel, and interventional study design. Fifty-eight chronic (> 3 months) stroke patients will be recruited from the Montpellier and Nimes University Hospitals. Patients will follow a standard 3-week in-patient rehabilitation program, which includes 13 days of VRT (Armeo Spring, 1 × 30 min session/day) and con...
Source: Trials - October 26, 2021 Category: Research Source Type: clinical trials

Effect of alkalized urine on renal calculi in patients with gout: a protocol for a placebo-controlled, double-blinded randomized controlled trial
The prevalence of renal calculi in patients with gout is high. Alkalized urine has been recommended by the 2020 European Association of Urology (EAU) guidelines to promote calculus dissolution. However, random... (Source: Trials)
Source: Trials - October 26, 2021 Category: General Medicine Authors: Ertao Jia, Haiqiong Zhu, Hongling Geng, Yadong Wang, Li Zhong, Shangwen Liu, Feng Lin and Jianyong Zhang Tags: Study protocol Source Type: research

The impact of deep versus standard neuromuscular block on intraoperative safety during laparoscopic surgery: an international multicenter randomized controlled double-blind strategy trial — EURO-RELAX TRIAL
Muscle relaxants are routinely used during anesthesia to facilitate endotracheal intubation and to optimize surgical conditions. However, controversy remains about the required depth of neuromuscular block (NM... (Source: Trials)
Source: Trials - October 26, 2021 Category: General Medicine Authors: Maarten Honing, Gabby Reijnders-Boerboom, Salome Dell-Kuster, Monique van Velzen, Chris Martini, Franco Valenza, Paolo Proto, Oscar D íaz Cambronero, Suzanne Broens, Ivo Panhuizen, Margot Roozekrans, Thomas Fuchs-Buder, Martijn Boon, Albert Dahan and Mic Tags: Study protocol Source Type: research

Female Urgency, Trial of Urodynamics as Routine Evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms
Overactive bladder (OAB) syndrome is a symptom complex affecting 12 –14% of the UK adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary freq... (Source: Trials)
Source: Trials - October 26, 2021 Category: General Medicine Authors: M. Abdel-fattah, C. Chapple, K. Guerrero, S. Dixon, N. Cotterill, K. Ward, H. Hashim, A. Monga, K. Brown, M. J. Drake, A. Gammie, A. Mostafa, U. K. Bladder Health, S. Breeman, D. Cooper, G. MacLennan & hellip; Tags: Study protocol Source Type: research

Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial
Polypharmacy in older adults can be associated with negative outcomes including falls, impaired cognition, reduced quality of life, and general and functional decline. It is not clear to what extent these are ... (Source: Trials)
Source: Trials - October 26, 2021 Category: General Medicine Authors: Dee Mangin, Larkin Lamarche, Gina Agarwal, Hoan Linh Banh, Naomi Dore Brown, Alan Cassels, Kiska Colwill, Lisa Dolovich, Barbara Farrell, Scott Garrison, James Gillett, Lauren E. Griffith, Anne Holbrook, Jane Jurcic-Vrataric, James McCormack, Daria O ’R Tags: Study protocol Source Type: research

Recovering arm function in chronic stroke patients using combined anodal HD-tDCS and virtual reality therapy (ReArm): a study protocol for a randomized controlled trial
After a stroke, 80% of the chronic patients have difficulties to use their paretic upper limb (UL) in activities of daily life (ADL) even after rehabilitation. Virtual reality therapy (VRT) and anodal transcra... (Source: Trials)
Source: Trials - October 26, 2021 Category: General Medicine Authors: Camille O. Muller, Makii Muthalib, Denis Mottet, St éphane Perrey, Gérard Dray, Marion Delorme, Claire Duflos, Jérôme Froger, Binbin Xu, Germain Faity, Simon Pla, Pierre Jean, Isabelle Laffont and Karima K. A. Bakhti Tags: Study protocol Source Type: research

The impact of deep versus standard neuromuscular block on intraoperative safety during laparoscopic surgery: an international multicenter randomized controlled double-blind strategy trial — EURO-RELAX TRIAL
DiscussionThis trial was designed to analyze the effect of deep neuromuscular block compared to standard neuromuscular block on intra- and postoperative adverse events in patients undergoing laparoscopic surgery.Trial registrationClinicalTrials.govNCT04124757(EURO-RELAX); registration URL:https://clinicaltrials.gov/ct2/show/NCT04124757, registered on  October 11th, 2019.  (Source: Trials)
Source: Trials - October 26, 2021 Category: Research Source Type: clinical trials

Female Urgency, Trial of Urodynamics as Routine Evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms
DiscussionThe FUTURE study will inform patients, clinicians and policy makers whether routine urodynamics improves treatment outcomes in women with refractory OAB and whether it is cost-effective.Trial registrationISRCTN63268739. Registered on 14 September 2017. (Source: Trials)
Source: Trials - October 26, 2021 Category: Research Source Type: clinical trials

Effect of alkalized urine on renal calculi in patients with gout: a protocol for a placebo-controlled, double-blinded randomized controlled trial
AbstractBackgroundThe prevalence of renal calculi in patients with gout is high. Alkalized urine has been recommended by the 2020 European Association of Urology (EAU) guidelines to promote calculus dissolution. However, randomized controlled trials are lacking.MethodsIn the protocol of this randomized, placebo-controlled, double-blinded trial, patients with gout combined with renal calculi are randomized (1:1) to the placebo and sodium bicarbonate groups. The intervention would be performed for 24 weeks, the 1 –12 weeks are double-blinded, and the 13–24 weeks are open-labeled. Sodium bicarbonate (1 g tid) will...
Source: Trials - October 26, 2021 Category: Research Source Type: clinical trials

Long-term improvement of psoriasis patients ’ adherence to topical drugs: testing a patient-supporting intervention delivered by healthcare professionals
DiscussionIf the intervention can reduce the severity of psoriasis in a significant manner and is economically favorable compared to standard treatment, there is potential for implementing the intervention in dermatology clinics.Trial registrationClinicaltrials.govNCT04220554. Registered on January 7, 2020. Study results, either positive, negative, or inconclusive, will be published onwww.clinicaltrials.gov.Trial registration no. with the Danish Regional Committee on Health Research Ethics, registration no. 72613. (Source: Trials)
Source: Trials - October 25, 2021 Category: Research Source Type: clinical trials

Negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI-2 trial): study protocol for a pragmatic, multicentre, cross surgical specialty, randomised controlled trial
DiscussionGiven the increasing use of NPWT, despite limited high-quality supporting evidence, the SWHSI-2 Trial will provide robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI.The SWHSI-2 Trial opened to recruitment in May 2019 and is currently recruiting across 20 participating centres.Trial registrationISRCTN 26277546. Prospectively registered on 25 March 2019 (Source: Trials)
Source: Trials - October 25, 2021 Category: Research Source Type: clinical trials

Study protocol for a randomised controlled trial to evaluate the effectiveness of a serious game targeting interpersonal emotion regulation in early adolescents
DiscussionThis RCT will test whether playing a serious game about iER strategies results in an improvement of iER skills and whether the game is feasible and acceptable for early adolescents with the ultimate aim to implement the game in schools and help early adolescents achieve positive peer relationships.Trial registrationClinicalTrials.govNCT04808102, Registered on 19 March 2021 (Source: Trials)
Source: Trials - October 25, 2021 Category: Research Source Type: clinical trials

Study protocol: multimodal physiotherapy as an add-on treatment to botulinum neurotoxin type A therapy for patients with cervical dystonia: DysPT-multi —a prospective, multicentre, single-blind, randomized, controlled study
This study is a multicentre, randomized, single-blind, controlled trial to demonstrate the effectiveness of a multimodal PT program compared to a nonspecific cupping therapy, additionally to the BoNT-A therapy. Two hundred participants will be assigned into the multimodal PT plus BoNT intervention arm or the BoNT plus cupping arm using randomization. Primary endpoint is the total Score of Toronto Western Spasmodic Rating Scale (TWSTRS). Secondary endpoints are the mobility of the cervical spine (range of motion, ROM), the TWSTRS subscales, and the quality of life (measured by questionnaires: CDQ-24 and SF-36). Patients wil...
Source: Trials - October 25, 2021 Category: Research Source Type: clinical trials

Optimizing blood pressure control by an Information Communication Technology-supported case management (PIA study): study protocol for a cluster-randomized controlled trial of a delegation model for general practices
AbstractBackgroundLongitudinal hypertension control prevents heart attacks, strokes, and other cardiovascular diseases. However, 49% of patients in German family medicine practices do not reach blood pressure (BP) targets (
Source: Trials - October 25, 2021 Category: Research Source Type: clinical trials

A brief intervention for PTSD versus treatment as usual: Study protocol for a non-inferiority randomized controlled trial
DiscussionShould BWRT prove to be non-inferior to treatment as usual, this brief intervention may be an important contribution to future psychological treatment for PTSD, by making trauma treatment more accessible and battling current barriers to care.Trial registration191548, 24.05.2021.ClinicalTrials.gov PRS: Release Confirmation (Source: Trials)
Source: Trials - October 25, 2021 Category: Research Source Type: clinical trials

A brief intervention for PTSD versus treatment as usual: Study protocol for a non-inferiority randomized controlled trial
Although existing treatment methods are effective in alleviating PTSD symptoms, several barriers to care exist, such as waiting times, avoidant tendencies, shame and stigma, potentially leading to fewer people... (Source: Trials)
Source: Trials - October 25, 2021 Category: General Medicine Authors: Halvor Stavland, Camilla Refvik, Jarle Eid, Rafiq Lockhat and Åsa Hammar Tags: Study protocol Source Type: research

Optimizing blood pressure control by an Information Communication Technology-supported case management (PIA study): study protocol for a cluster-randomized controlled trial of a delegation model for general practices
Longitudinal hypertension control prevents heart attacks, strokes, and other cardiovascular diseases. However, 49% of patients in German family medicine practices do not reach blood pressure (BP) targets ( (Source: Trials)
Source: Trials - October 25, 2021 Category: General Medicine Authors: Arian Karimzadeh, Frauke Leupold, Anika Thielmann, Nicola Amarell, Kerstin Klidis, Verena Schroeder, Christine Kersting, Claudia Ose, Karl-Heinz Joeckel and Birgitta Weltermann Tags: Study protocol Source Type: research

Negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI-2 trial): study protocol for a pragmatic, multicentre, cross surgical specialty, randomised controlled trial
The majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to he... (Source: Trials)
Source: Trials - October 25, 2021 Category: General Medicine Authors: Ian Chetter, Catherine Arundel, Belen Corbacho Martin, Catherine Hewitt, Caroline Fairhurst, Kalpita Joshi, Andrew Mott, Sara Rodgers, Pedro Saramago Goncalves, David Torgerson, Jacqueline Wilkinson, Jane Blazeby, Rhiannon Macefield, Stephen Dixon, Eileen Tags: Study protocol Source Type: research

Study protocol: multimodal physiotherapy as an add-on treatment to botulinum neurotoxin type A therapy for patients with cervical dystonia: DysPT-multi —a prospective, multicentre, single-blind, randomized, controlled study
Botulinum neurotoxin (BoNT) is currently the best therapeutic option in the treatment for cervical dystonia (CD). Additional treatments like physiotherapy (PT) may even improve the results of the BoNT injectio... (Source: Trials)
Source: Trials - October 25, 2021 Category: General Medicine Authors: Christian Werner, Dana Loudovici-Krug, Steffen Derlien, Florian Rakers, Ulrich C. Smolenski, Thomas Lehmann, Norman Best and Albrecht G ünther Tags: Study protocol Source Type: research

Study protocol for a randomised controlled trial to evaluate the effectiveness of a serious game targeting interpersonal emotion regulation in early adolescents
Adaptive interpersonal emotion regulation (iER) is a vital tool for positive relations. During early adolescence, peer relations become increasingly important, making this age group a relevant target group for... (Source: Trials)
Source: Trials - October 25, 2021 Category: General Medicine Authors: Gloria Mittmann, Sonja Zehetmayer and Beate Schrank Tags: Study protocol Source Type: research

Clinical trial recruiters ’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK
ConclusionsOur survey corroborates other evidence about the existence of suboptimal trial eligibility criteria. Problems with clarity were the most often reported, but the number of comments on feasibility and suitability suggest some recruiters feel eligibility criteria and associated assessments can hinder recruitment to trials. Our proposal for more recruiter involvement in protocol development has strong support and some potential benefits, but questions remain about how best to implement this. We invite other trialists to consider our other suggestions for how to assure quality in trial eligibility criteria. (Source: Trials)
Source: Trials - October 24, 2021 Category: Research Source Type: clinical trials

The clinical and cost-effectiveness of a self-management intervention for patients with persistent depressive disorder and their partners/caregivers: study protocol of a multicenter pragmatic randomized controlled trial
After regular treatment, patients with persistent depressive disorder (PDD) may remain in specialized psychiatric outpatient care without achieving remission. Lacking other options, these patients often receiv... (Source: Trials)
Source: Trials - October 23, 2021 Category: General Medicine Authors: Ericka C. Solis, Ingrid V. E. Carlier, Nic J. A. van der Wee and Albert M. van Hemert Tags: Study protocol Source Type: research

Statistical analysis plan for the Early Youth Engagement in first episode psychosis (EYE-2) study: a pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement
Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12  months with costs to their ment... (Source: Trials)
Source: Trials - October 23, 2021 Category: General Medicine Authors: Christopher Iain Jones, Stephen Bremner, Richard Hooper, Jenny Gu, Gergely Bartl and Kathryn Greenwood Tags: Update Source Type: research

The INITIATE trial protocol: a randomized controlled trial testing the effectiveness of a “quit card” intervention on long-term abstinence among tobacco smokers presenting to the emergency department
Smoking cessation interventions implemented in emergency department (ED) settings have resulted in limited success, owing to factors such as lack of time, motivation, and incentives. A dynamic yet simple and e... (Source: Trials)
Source: Trials - October 23, 2021 Category: General Medicine Authors: Kerri A. Mullen, Aditi Garg, Frederick Gagnon, George Wells, Atul Kapur, Steven Hawken, Andrew L. Pipe, Kathryn Walker, Venkatesh Thiruganasambandamoorthy, Marta Klepaczek and Robert D. Reid Tags: Study protocol Source Type: research

Adapting the design of a Web-based decision support clinical trial during the COVID-19 pandemic
The public health crises that emerged in the COVID-19 pandemic significantly impacted the provision of medical care and placed sudden restrictions on ongoing clinical research. Patient-facing clinical research... (Source: Trials)
Source: Trials - October 23, 2021 Category: General Medicine Authors: Jessica Meline, Jason M. Prigge, Debbie Dye, Julie Rieder, Onur Asan, Sumedha Chhatre, Liana Fraenkel, Jeffrey D. Kravetz, Keri L. Rodriguez, Jeff Whittle, Dana Kaminstein and Marilyn M. Schapira Tags: Commentary Source Type: research

Patient and public involvement in randomised clinical trials: a mixed-methods study of a clinical trials unit to identify good practice, barriers and facilitators
While patient and public involvement (PPI) in clinical trials is beneficial and mandated by some funders, formal guidance on how to implement PPI is limited and challenges have been reported. We aimed to inves... (Source: Trials)
Source: Trials - October 23, 2021 Category: General Medicine Authors: Lucy Ellen Selman, Clare Clement, Margaret Douglas, Keith Douglas, Jodi Taylor, Chris Metcalfe, J. Athene Lane and Jeremy Horwood Tags: Research Source Type: research

Patient and public involvement in randomised clinical trials: a mixed-methods study of a clinical trials unit to identify good practice, barriers and facilitators
ConclusionsWhile highly valuable, PPI in trials is currently variable. PPI representatives are recruited informally, may not be provided with any training and are paid inconsistently across trials. Study findings can help optimise PPI in trials and ensure researchers and public contributors are adequately supported. (Source: Trials)
Source: Trials - October 23, 2021 Category: Research Source Type: clinical trials

The clinical and cost-effectiveness of a self-management intervention for patients with persistent depressive disorder and their partners/caregivers: study protocol of a multicenter pragmatic randomized controlled trial
This study investigates the “Patient and Partner Education Program for All Chronic Illnesses” (PPEP4All) as a brief self-management protocol that could lead to lower costs, higher quality of life, and less disease burden in PDD patients and their partners/caregivers.MethodsPresented is the rationale and methods of a multicenter pragmatic randomized controlled trial to evaluate the clinical efficacy and cost-effectiveness of PPEP4All for patients with PDD and their partners/caregivers. In accordance with current recommendations, a mixed methods research approach is used with both quantitative and qualitative dat...
Source: Trials - October 23, 2021 Category: Research Source Type: clinical trials

Statistical analysis plan for the Early Youth Engagement in first episode psychosis (EYE-2) study: a pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement
This study will evaluate the effectiveness of a team-based motivational engagement intervention, the Early Youth Engagement (EYE-2) intervention.Methods and designThe EYE-2 trial is a cluster randomised controlled trial comparing the EYE-2 intervention plus standardised EIP service to standardised EIP service alone, with randomisation at the clinical team (cluster) level. The study aimed to enrol 950 young people (aged  14–35 years) with first episode psychosis in 10 teams per arm.ResultsThe primary outcome is time to disengagement: days from the date of allocation to care coordinator to date of the last ...
Source: Trials - October 23, 2021 Category: Research Source Type: clinical trials

Adapting the design of a Web-based decision support clinical trial during the COVID-19 pandemic
ConclusionOur experience highlights strategies successfully employed to adapt an intervention and behavioral research study protocol during the COVID-19 pandemic. This experience will inform clinical research moving forward both during and subsequent to the constraints placed on research and clinical care during the COVID-19 pandemic. (Source: Trials)
Source: Trials - October 23, 2021 Category: Research Source Type: clinical trials

The INITIATE trial protocol: a randomized controlled trial testing the effectiveness of a “quit card” intervention on long-term abstinence among tobacco smokers presenting to the emergency department
This study proposes a multi-center randomized controlled trial (RCT) to compare the effectiveness of an easy to deliver proactive, multi-component tobacco treatment intervention to usual care in the ED setting.MethodsThis will be a prospective four-site, single-blind, blinded-endpoint (PROBE) RCT. Participants will be recruited directly in the ED and will be approached strictly in order of arrival time. Those randomized to the Quit Card Intervention (QCI) group will receive a “quit kit” which will include: a “Quit Card” worth $300 that can be used at any Canadian pharmacy to purchase any form of nic...
Source: Trials - October 23, 2021 Category: Research Source Type: clinical trials

Evaluating the potential of respiratory-sinus-arrhythmia biofeedback for reducing physiological stress in adolescents with autism: study protocol for a randomized controlled trial
DiscussionFirst, more conclusive evidence will be provided for the presence of lower cardiac vagal modulation in adolescents with ASD as well as the association between these lower values and physiological and behavioral indices. Second, the supervised intervention in adolescents with ASD is hypothesized to upregulate this cardiac vagal modulation and positively change behavioral and physiological parameters. Third, evidence regarding the feasibility and acceptability of a non-supervised intervention may open novel avenues for home-based interventions in this population.Trial registrationClinicalTrials.govNCT04628715. Regi...
Source: Trials - October 21, 2021 Category: Research Source Type: clinical trials

A lived experience co-designed study protocol for a randomised control trial: the Attempted Suicide Short Intervention Program (ASSIP) or Brief Cognitive Behavioural Therapy as additional interventions after a suicide attempt compared to a standard Suicide Prevention Pathway (SPP)
Despite being preventable, suicide is a leading cause of death and a major global public health problem. For every death by suicide, many more suicide attempts are undertaken, and this presents as a critical r... (Source: Trials)
Source: Trials - October 21, 2021 Category: General Medicine Authors: Nicolas J. C. Stapelberg, Candice Bowman, Sabine Woerwag-Mehta, Sarah Walker, Angela Davies, Ian Hughes, Konrad Michel, Anthony R. Pisani, Heidy Van Engelen, Mia Delos, Tamara Hageman, Kim Fullerton-Smith, Ravikumar Krishnaiah, Sarah McDowell, Alison Came Tags: Study protocol Source Type: research

The 4MOTHERS trial of the impact of a mobile money-based intervention on maternal and neonatal health outcomes in Madagascar: study protocol of a cluster-randomized hybrid effectiveness-implementation trial
Mobile money —a service enabling users to receive, store, and send electronic money using mobile phones—has been widely adopted across low- and middle-income economies to pay for a variety of services, includin... (Source: Trials)
Source: Trials - October 21, 2021 Category: General Medicine Authors: Etienne Lacroze, Till B ärnighausen, Jan Walter De Neve, Sebastian Vollmer, Rolland Marie Ratsimbazafy, Peter Martin Ferdinand Emmrich, Nadine Muller, Elsa Rajemison, Zavaniarivo Rampanjato, Diana Ratsiambakaina, Samuel Knauss and Julius Valentin Emmrich Tags: Study protocol Source Type: research

Innovative clinical trial design and delivery: a phase 3 COVID-19 post-exposure prophylaxis study in skilled nursing and assisted living facilities (BLAZE-2)
The efficient community spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in the current pandemic of coronavirus disease-2019 (COVID-19), which in severe and critical cases re... (Source: Trials)
Source: Trials - October 21, 2021 Category: General Medicine Authors: Jack Knorr, Jay L. Tuttle, Janelle A. Sabo, Dawn H. East, Karen L. Price and Lei Shen Tags: Letter Source Type: research

Effect of hydrogen gas inhalation on patient QOL after hepatectomy: protocol for a randomized controlled trial
Molecular hydrogen had been considered inactive in vivo but is an antioxidant that selectively reduces highly toxic reactive oxygen species (ROS). Animal studies have reported that hydrogen gas inhalation help... (Source: Trials)
Source: Trials - October 21, 2021 Category: General Medicine Authors: Masaki Kaibori and Hisashi Kosaka Tags: Study protocol Source Type: research

Salvage hypofractionated accelerated versus standard radiotherapy for the treatment of biochemical recurrence after radical prostatectomy (SHARE): the protocol of a prospective, randomized, open-label, superiority, multi-institutional trial
While several phase III trials have investigated the role of hypofractionated radiotherapy in the definitive treatment of localized prostate cancer, prospective data reporting the outcomes of hypofractionated ... (Source: Trials)
Source: Trials - October 21, 2021 Category: General Medicine Authors: Geumju Park, Yeon Joo Kim, Hanjong Ahn, Won Park, Ji sung Lee and Young Seok Kim Tags: Study protocol Source Type: research

Effect of hydrogen gas inhalation on patient QOL after hepatectomy: protocol for a randomized controlled trial
This study is a randomized, controlled, double-blind superiority trial, which will be conducted as a “specified clinical trial” in accordance with the Clinical Trials Act in Japan. Trial registration was prospectively completed before the first participant was enrolled.The subjects will be patients who will undergo hepatectomy and will be allocated randomly into group A with hydrogen gas inhalation or group B with air inhalation after hepatectomy. The study will examine if hydrogen gas inhalation improves QOL of post-hepatectomy patients. The primary endpoint is patient QOL (score of a 40-item quality of recove...
Source: Trials - October 21, 2021 Category: Research Source Type: clinical trials

Motor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS) after traumatic knee injury: study protocol for an adaptive randomized controlled trial
DiscussionStrengths of this trial include that it is a randomized and pragmatic trial examining commonly under-studied aspects of rehabilitation following a knee injury. The model uses the patient as a reference, creating simultaneous psychological and physical training exercises with easily adopted principles for clinical practice. Limitations include that blinding is limited due to study design, and shifting the clinical paradigm to a more holistic model is a challenge. If successful, the MOTIFS model has implications for a clinically useful, individualized, and patient-relevant method of improving rehabilitation outcome...
Source: Trials - October 21, 2021 Category: Research Source Type: clinical trials

A trial platform to assess approved SARS-CoV-2 vaccines in immunocompromised patients: first sub-protocol for a pilot trial comparing the mRNA vaccines Comirnaty ® and COVID-19 mRNA Vaccine Moderna®
This study will provide crucial information about the efficacy and safety of the mRNA SARS-CoV-2 vaccines in HIV patients and organ transplant recipients. Furthermore, this project has the potential to pave the way for further platform trials in Switzerland.Trial registrationClinicalTrials.govNCT04805125. Registered on March 18, 2021 (Source: Trials)
Source: Trials - October 21, 2021 Category: Research Source Type: clinical trials

The 4MOTHERS trial of the impact of a mobile money-based intervention on maternal and neonatal health outcomes in Madagascar: study protocol of a cluster-randomized hybrid effectiveness-implementation trial
DiscussionA cluster-randomized, hybrid effectiveness-implementation design allows for a robust approach to determine whether the MMHW is a feasible and beneficial intervention in a resource-restricted public healthcare environment. We expect the results of our study to guide future initiatives and health policy decisions related to maternal and neonatal health and universal healthcare coverage through technology in Madagascar and other countries in sub-Saharan Africa.Trial registrationThis trial was registered on March 12, 2021: Deutsches Register Klinischer Studien (German Clinical Trials Register), identifier:DRKS0001492...
Source: Trials - October 21, 2021 Category: Research Source Type: clinical trials

Innovative clinical trial design and delivery: a phase 3 COVID-19 post-exposure prophylaxis study in skilled nursing and assisted living facilities (BLAZE-2)
AbstractThe efficient community spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in the current pandemic of coronavirus disease-2019 (COVID-19), which in severe and critical cases results in progressive pulmonary infection, complicated by respiratory failure, with a high prevalence of acute respiratory distress syndrome. Of all age groups, older adults have the greatest risk of severe COVID-19 and the associated complications. Globally, there are many reports of the rapid spread of COVID-19 among residents of skilled nursing facilities, with high associated rates of morbidity and mortalit...
Source: Trials - October 21, 2021 Category: Research Source Type: clinical trials

Salvage hypofractionated accelerated versus standard radiotherapy for the treatment of biochemical recurrence after radical prostatectomy (SHARE): the protocol of a prospective, randomized, open-label, superiority, multi-institutional trial
This study is designed to demonstrate whether hypofractionated radiotherapy is beneficial in terms of biochemical control and toxicity compared with standard salvage radiotherapy. If hypofractionated radiotherapy is shown to be superior to conventionally fractionated radiotherapy, it will mean that improved biochemical control can be achieved, accompanied by greater patient convenience and more efficient use of medical resources.Trial registrationClinicalTrials.gov NCT03920033. Registered on 18 April 2019 (Source: Trials)
Source: Trials - October 21, 2021 Category: Research Source Type: clinical trials

A lived experience co-designed study protocol for a randomised control trial: the Attempted Suicide Short Intervention Program (ASSIP) or Brief Cognitive Behavioural Therapy as additional interventions after a suicide attempt compared to a standard Suicide Prevention Pathway (SPP)
DiscussionThis project will move both ASSIP and Brief CBT from efficacy to effectiveness research, with clear aims of assessing the addition of two structured psychological interventions to treatment as usual, providing a cost-benefit analysis of the interventions, thus delivering outcomes providing a clear pathway for rapid translation of successful interventions.Trials registrationClinicalTrials.govNCT04072666. Registered on 28 August 2019 (Source: Trials)
Source: Trials - October 21, 2021 Category: Research Source Type: clinical trials

Efficacy and safety of dual intravenous artesunate plus quinine compared to intravenous artesunate for cerebral malaria in a triple blinded parallel multisite randomized controlled trial in Nigerian children: DUAL PAQ TRIAL Protocol
Evidence exists as to the criticality of the first 24  h in the management of cerebral malaria. The morbidity and the mortality rate (35%) with the current intravenous monotherapy for the initial treatment of c... (Source: Trials)
Source: Trials - October 20, 2021 Category: General Medicine Authors: Michael Abel Alao, Adebola Emmanuel Orimadegun, Olayinka Rasheed Ibrahim, Abayomi O. Oyenuga, Adanze Onyenonachi Asinobi, Daniel Adedosu Gbadero, Ifeoma Joy Okoye and Emmanuel Okechukwu Nna Tags: Study protocol Source Type: research

Efficacy of expressive helping in adult hematologic cancer patients undergoing stem cell transplant: protocol for the Writing for Insight, Strength, and Ease (WISE) study ’s two-arm randomized controlled trial
During, shortly after, and sometimes for years after hematopoietic stem cell transplant, a large proportion of hematological cancer patients undergoing transplant report significant physical and psychological ... (Source: Trials)
Source: Trials - October 20, 2021 Category: General Medicine Authors: Lauren Whitmore, Taylor Schulte, Katrin Bovbjerg, Madison Hartstein, Jane Austin, George Luta, Lily McFarland, Scott D. Rowley, Themba Nyirenda, Marquita Lewis-Thames, Annette L. Stanton, Heiddis Valdimarsdottir, Kristi Graves and Christine Rini Tags: Study protocol Source Type: research

Efficacy of expressive helping in adult hematologic cancer patients undergoing stem cell transplant: protocol for the Writing for Insight, Strength, and Ease (WISE) study ’s two-arm randomized controlled trial
DiscussionThe steady and continuing increase in use of stem cell transplantation has created growing need for efficacious, accessible interventions to reduce the short- and long-term negative physical and psychosocial effects of this challenging but potentially life-saving treatment. Expressive helping is a psychological intervention that was designed to fill this gap. It has been shown to be efficacious in long-term transplant survivors but could have even greater impact if it is capable of reducing symptoms during and soon after transplant. The WISE study will evaluate these benefits in a rigorous randomized controlled t...
Source: Trials - October 20, 2021 Category: Research Source Type: clinical trials

Efficacy and safety of dual intravenous artesunate plus quinine compared to intravenous artesunate for cerebral malaria in a triple blinded parallel multisite randomized controlled trial in Nigerian children: DUAL PAQ TRIAL Protocol
This study outlines a protocol to conduct a triple blinded parallel randomized controlled trial on cerebral malaria using dual intravenous medications compared to the current standard of monotherapy.MethodsThis is a parallel multi-site randomized controlled superiority triple blinded trial consisting of intravenous artesunate plus quinine and a control arm of intravenous artesunate only. Eligible and assenting children aged 6  months to 17 years will be recruited from 4 tertiary hospitals by random selection from the list of tertiary hospitals in Nigeria. Participants will be randomized and assigned in parall...
Source: Trials - October 20, 2021 Category: Research Source Type: clinical trials