scholarly journals Salivary and Nasal Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses (BBCovid): A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Florence Carrouel ◽  
Stéphane Viennot ◽  
Martine Valette ◽  
Jean-Marie Cohen ◽  
Claude Dussart ◽  
...  
Keyword(s):  
Viral Load ◽  
Randomised Controlled Trial ◽  
Real Time ◽  
Outcome Measures ◽  
Real Time Pcr ◽  
Controlled Trial ◽  
Full Protocol ◽  
Pcr Assays ◽  
Randomised Controlled ◽  
Hospital Center

Abstract Objectives - To describe the evolution of the SARS-CoV-2 salivary viral load of patients infected with Covid-19, performing 7 days of tri-daily mouthwashes with and without antivirals. - To compare the evolution of the SARS-CoV-2 nasal and salivary viral load according to the presence or absence of antivirals in the mouthwash. Trial design This is a multi-center, randomised controlled trial (RCT) with two parallel arms (1:1 ratio). Participants Inclusion criteria - Age: 18-85 years old - Clinical diagnosis of Covid-19 infection - Clinical signs have been present for less than 8 days - Virological confirmation - Understanding and acceptance of the trial - Written agreement to participate in the trial Exclusion criteria - Pregnancy, breastfeeding, inability to comply with protocol, lack of written agreement - Patients using mouthwash on a regular basis (more than once a week) - Patient at risk of infectious endocarditis - Patients unable to answer questions - Uncooperative patient The clinical trial is being conducted with the collaboration of three French hospital centers: Hospital Center Emile Roux (Le Puy en Velay, France), Clinic of the Protestant Infirmary (Lyon, France) and Intercommunal Hospital Center (Mont de Marsan, France). Intervention and comparator Eligible participants will be allocated to one of the two study groups. Intervention group: patients perform a tri-daily mouthwash with mouthwash containing antivirals (β-cyclodextrin and Citrox®) for a period of 7 days. Control group: patients perform a tri-daily mouthwash with a placebo mouthwash for a period of 7 days. Main outcomes Primary Outcome Measures: Change from Baseline amount of SARS-CoV-2 in salivary samples at 4 and 9 hours, 1, 2, 3, 4, 5 and 6 days. Real-time PCR assays are performed to assess salivary SARS-CoV 2 viral load. Secondary Outcome Measures: Change from Baseline amount of SARS-CoV-2 virus in nasal samples at 6 days. Real-time PCR assays are performed to assess nasal SARS-CoV-2 viral load. Randomisation Participants meeting all eligibility requirements are allocated to one of the two study arms (mouthwash with β-cyclodextrin and Citrox® or mouthwash without β-cyclodextrin and Citrox®) in a 1:1 ratio using simple randomisation with computer generated random numbers. Blinding (masking) Participants, doctors and nurses caring for participants, laboratory technicians and investigators assessing the outcomes will be blinded to group assignment. Numbers to be randomised (sample size) Both the intervention and control groups will be composed of 103 participants, so the study will include a total of 206 participants. Trial Status The current protocol version is 6, August 4th, 2020. Recruitment began on April 6, 2020 and is anticipated to be complete by April 5, 2021. As of October 2, 2020, forty-two participants have been included. Trial registration This trial was registered on 20 April 2020 at www.clinicaltrials.gov with the number NCT04352959. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.” The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).”

scholarly journals Randomised controlled trial of Compensatory Cognitive Training and a Computerised Cognitive Remediation programme

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Frances Dark ◽  
Ellie Newman ◽  
Victoria Gore-Jones ◽  
Veronica De Monte ◽  
Marta I. Garrido ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Cognitive Training ◽  
Controlled Trial ◽  
Schizophrenia Spectrum Disorders ◽  
Cognitive Interventions ◽  
Schizophrenia Spectrum ◽  
Spectrum Disorders ◽  
Randomised Controlled

Abstract Background Compensation and adaptation therapies have been developed to improve community functioning via improving neurocognitive abilities in people with schizophrenia. Various modes of delivering compensation and adaptation therapies have been found to be effective. The aim of this trial is to compare two different cognitive interventions, Compensatory Cognitive Training (CCT) and Computerised Interactive Remediation of Cognition–Training for Schizophrenia (CIRCuiTS). The trial also aims to identify if mismatch negativity (MMN) can predict an individual’s response to the compensation and adaptation programmes. Methods This study will use a randomised, controlled trial of two cognitive interventions to compare the impact of these programmes on measures of neurocognition and function. One hundred clinically stable patients aged between 18 and 65 years with a diagnosis of a schizophrenia spectrum disorder will be recruited. Participants will be randomised to either the CCT or the CIRCuiTS therapy groups. The outcome measures are neurocognition (BACS), subjective sense of cognitive impairment (SSTICS), social functioning (SFS), and MMN (measured by EEG) in people with schizophrenia spectrum disorders. Discussion This trial will determine whether different approaches to addressing the cognitive deficits found in schizophrenia spectrum disorders are of comparable benefit using the outcome measures chosen. This has implications for services where cost and lack of computer technology limit the implementation and dissemination of interventions to address cognitive impairment in routine practice. The trial will contribute to the emerging evidence of MMN as a predictor of response to cognitive interventions. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000161224. Registered on 2 February 2018. Protocol version: 4.0, 18 June 2018.

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Postcard intervention for repeat self-harm: randomised controlled trial

2010 ◽  
Vol 197 (1) ◽  
pp. 55-60 ◽  
Author(s):  
Annette L. Beautrais ◽  
Sheree J. Gibb ◽  
Alan Faulkner ◽  
David M. Fergusson ◽  
Roger T. Mulder
Keyword(s):  
Emergency Department ◽  
New Zealand ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Suicidal Behaviour ◽  
Controlled Trial ◽  
Elevated Risk ◽  
Emergency Department Presentation ◽  
Self Harm ◽  
Randomised Controlled

BackgroundSelf-harm and suicidal behaviour are common reasons for emergency department presentation. Those who present with self-harm have an elevated risk of further suicidal behaviour and death.AimsTo examine whether a postcard intervention reduces self-harm re-presentations in individuals presenting to the emergency department.MethodRandomised controlled trial conducted in Christchurch, New Zealand. The intervention consisted of six postcards mailed during the 12 months following an index emergency department attendance for self-harm. Outcome measures were the proportion of participants re-presenting with self-harm and the number of re-presentations for self-harm in the 12 months following the initial presentation.ResultsAfter adjustment for prior self-harm, there were no significant differences between the control and intervention groups in the proportion of participants re-presenting with self-harm or in the total number of re-presentations for self-harm.ConclusionsThe postcard intervention did not reduce further self-harm. Together with previous results this finding suggests that the postcard intervention may be effective only for selected subgroups.

scholarly journals Comparison of efficacy and safety between electroacupuncture at ‘four sacral points’ and conventional electroacupuncture for the treatment of urinary incontinence after stroke: study protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e021783 ◽  
Author(s):  
Shan Chen ◽  
Siyou Wang ◽  
Lihua Xuan ◽  
Hanti Lu ◽  
Zhikai Hu ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Randomised Controlled Trial ◽  
Medical Care ◽  
Outcome Measures ◽  
Pudendal Nerve ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Routine Medical Care ◽  
Randomised Controlled

IntroductionElectroacupuncture at ‘four sacral points’, also known as electrical pudendal nerve stimulation therapy, combines the advantages of pudendal nerve neuromodulation and the technique of deep insertion of long acupuncture needles. It has been used to treat stress urinary incontinence, female urgency-frequency syndrome, idiopathic urgency urinary incontinence and neurological bladders in previous studies. Here, we describe the protocol for a randomised controlled trial for evaluation of the efficacy and safety of electroacupuncture at ‘four sacral points’ for the management of urinary incontinence after stroke.Methods and analysisThis is an open-label randomised controlled trial with blinded assessments and analyses. A total of 140 eligible patients will be randomly allocated to two groups. The treatment group (n=70) will receive electroacupuncture at ‘four sacral points’ along with routine medical care, while the control group will receive conventional electroacupuncture along with routine medical care. Twenty treatment sessions will occur over a period of 4 weeks. The primary outcome measures will be the self-recorded findings in an incontinent episode diary at baseline and at 4 weeks after baseline. The secondary outcome measures will be the International Consultation on Incontinence Questionnaire Urinary Incontinence—Short Form (ICIQ-UI SF) score and the Barthel Activities of Daily Living Index (Barthel ADL Index) score at baseline and at 4 and 28 weeks after baseline.Ethics and disseminationThis protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059–01). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.Trial registration numberChiCTR-IOR-17012847; Pre-result.

Effects of golf training on cognition in older adults: a randomised controlled trial

2018 ◽  
Vol 72 (10) ◽  
pp. 944-950 ◽  
Author(s):  
Hiroyuki Shimada ◽  
Sangyoon Lee ◽  
Masahiro Akishita ◽  
Koichi Kozaki ◽  
Katsuya Iijima ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Training Group ◽  
Community Dwelling ◽  
Secondary Outcome ◽  
Control Group ◽  
Logical Memory ◽  
Randomised Controlled

BackgroundAlthough research indicates that a physically active lifestyle has the potential to prevent cognitive decline and dementia, the optimal type of physical activity/exercise remains unclear. The present study aimed to determine the cognitive benefits of a golf-training programme in community-dwelling older adults.MethodsWe conducted a randomised controlled trial between August 2016 and June 2017 at a general golf course. Participants included 106 Japanese adults aged 65 and older. Participants were randomly assigned to either a 24-week (90–120 min sessions/week) golf-training group or a health education control group. Postintervention changes in Mini-mental State Examination (MMSE) and National Centre for Geriatrics and Gerontology-Functional Assessment Tool scores were regarded as primary outcome measures. Secondary outcome measures included changes in physical performance and Geriatric Depression Scale (GDS) scores.ResultsA total of 100 participants (golf training, n=53; control, n=47) completed the assessments after the 24-week intervention period. The adherence to the golf programme was 96.2% (51/53 participants). Analysis using linear mixed models revealed that the golf training group exhibited significantly greater improvements in immediate logical memory (p=0.033), delayed logical memory (p=0.009) and composite logical memory (p=0.013) scores than the control group. However, no significant changes in MMSE, word memory, Trail Making Test or Symbol Digital Substitution Test scores were observed. In addition, no significant changes in grip strength, walking speed or GDS were observed.ConclusionsGolf-based exercise interventions may improve logical memory in older adults, but no significant changes in other cognitive tests. Further follow-up investigations are required to determine whether the observed effects are associated with delayed onset of mild cognitive impairment or Alzheimer’s disease in older adults.Trial registration numberUMIN-CTR UMIN000024797; Pre-results.

scholarly journals A feasibility randomised controlled trial of short-term fasting prior to CAPOX chemotherapy for stage 2/3 colorectal cancer: SWiFT protocol

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Ellie Shingler ◽  
Claire Perks ◽  
Georgia Herbert ◽  
Andy Ness ◽  
Charlotte Atkinson
Keyword(s):  
Colorectal Cancer ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Trial Registration ◽  
Secondary Outcome ◽  
Dietary Advice ◽  
Short Term ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Capecitabine and oxaliplatin (CAPOX) chemotherapy is a standard treatment for stage 2/3 colorectal cancer. Treatment is associated with dose-limiting toxicities such as neutropenia, vomiting, diarrhoea, and stomatitis. Short-term fasting prior to chemotherapy may help protect normal cells from the toxic effects of chemotherapy by allowing them to conserve energy for maintenance and repair. However, there is a lack of evidence to support the efficacy of short-term fasting in protecting against chemotherapy-related toxicities in humans, and it is not known whether people due to undergo chemotherapy will be willing and able to follow a short-term fast. Preliminary data confirming this is feasible are required before adequately powered trials can be designed and conducted. Methods The short-term, water only, fasting trial (SWiFT) is a two-armed feasibility randomised controlled trial, aiming to recruit 30 people scheduled to begin routine treatment with CAPOX chemotherapy for stage 2/3 colorectal cancer. Participants will be randomly allocated, in a 1:1 ratio, to either a 36-h fast or standard dietary advice prior to chemotherapy administration for the first 3 cycles of chemotherapy. The primary outcome measures will assess the feasibility of the trial and include: adherence to intervention, recruitment, retention, and data completion rates as well as the acceptability of the intervention which will be qualitatively assessed. The secondary outcome measures aim to provide further information on possible outcomes of interest for a definitive trial and include side effects of chemotherapy, quality of life, markers of cellular metabolism and inflammation, appetite, and sarcopenia. Discussion It is not known whether it is possible to recruit to a trial of short-term fasting in this population, or whether participants would be able to adhere to the intervention. Therefore, we aim to test the feasibility of a pre-chemotherapy, 36-h, water-only fast in people receiving CAPOX chemotherapy for stage 2/3 colorectal cancer. Trial registration This trial has been registered with the ISRCTN Registry. Trial registration no: ISRCTN17994717. Date of registration: 23 October 2018. URL: http://www.isrctn.com/ISRCTN17994717

scholarly journals Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Anne Marie Rosendahl Madsen ◽  
Frederik Schaltz-Buchholzer ◽  
Thomas Benfield ◽  
Morten Bjerregaard-Andersen ◽  
Lars Skov Dalgaard ◽  
...  
Keyword(s):  
Health Care ◽  
Randomised Controlled Trial ◽  
Health Care Workers ◽  
Cumulative Incidence ◽  
Controlled Trial ◽  
Bcg Vaccine ◽  
Care Workers ◽  
Full Protocol ◽  
Randomised Controlled ◽  
Study Participants

Abstract Objectives: The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and mortality have been reported. We aim to test whether BCG vaccination may reduce susceptibility to and/or the severity of COVID-19 and other infectious diseases in health care workers (HCW) and thus prevent work absenteeism. The primary objective is to reduce absenteeism due to illness among HCW during the COVID-19 pandemic. The secondary objectives are to reduce the number of HCW that are infected with SARS-CoV-2, and to reduce the number of hospital admissions among HCW during the COVID-19 pandemic. Hypothesis: BCG vaccination of HCW will reduce absenteeism by 20% over a period of 6 months. Trial design: Placebo-controlled, single-blinded, randomised controlled trial, recruiting study participants at several geographic locations. The BCG vaccine is used in this study on a different indication than the one it has been approved for by the Danish Medicines Agency, therefore this is classified as a phase III study. Participants: The trial will recruit 1,500 HCW at Danish hospitals. To be eligible for participation, a subject must meet the following criteria: Adult (≥18 years); Hospital personnel working at a participating hospital for more than 22 hours per week. A potential subject who meets any of the following criteria will be excluded from participation in this study: Known allergy to components of the BCG vaccine or serious adverse events to prior BCG administration Known prior active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species Previous confirmed COVID-19 Fever (>38 C) within the past 24 hours Suspicion of active viral or bacterial infection Pregnancy Breastfeeding Vaccination with other live attenuated vaccine within the last 4 weeks Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1) b) subjects with solid organ transplantation c) subjects with bone marrow transplantation d) subjects under chemotherapy e) subjects with primary immunodeficiency f) subjects under treatment with any anti-cytokine therapy within the last year g) subjects under treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months h) Active solid or non-solid malignancy or lymphoma within the prior two years Direct involvement in the design or the execution of the BCG-DENMARK-COVID trial Intervention and comparator: Participants will be randomised to BCG vaccine (BCG-Denmark, AJ Vaccines, Copenhagen, Denmark) or placebo (saline). An adult dose of 0.1 ml of resuspended BCG vaccine (intervention) or 0.1 ml of sterile 0.9% NaCl solution (control) is administered intradermally in the upper deltoid area of the right arm. All participants will receive one injection at inclusion, and no further treatment of study participants will take place. Main outcomes: Main study endpoint: Days of unplanned absenteeism due to illness within 180 days of randomisation. Secondary study endpoints: The cumulative incidence of documented COVID-19 and the cumulative incidence of hospital admission for any reason within 180 days of randomisation. Randomisation: Randomisation will be done centrally using the REDCap tool with stratification by hospital, sex and age groups (+/- 45 years of age) in random blocks of 4 and 6. The allocation ratio is 1:1. Blinding (masking): Participants will be blinded to treatment. The participant will be asked to leave the room while the allocated treatment is prepared. Once ready for injection, vaccine and placebo will look similar, and the participant will not be able to tell the difference. The physicians administering the treatment are not blinded. Numbers to be randomised (sample size): Sample size: N=1,500. The 1,500 participants will be randomised 1:1 to BCG or placebo with 750 participants in each group. Trial Status: Current protocol version 5.1, from July 6, 2020. Recruitment of study participants started on May 18, 2020 and we anticipate having finished recruiting by the end of December 2020. Trial registration: The trial was registered with EudraCT on April 16, 2020, EudraCT number: 2020-001888-90, and with ClinicalTrials.gov on May 1, 2020, registration number NCT04373291. Full protocol: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. Keywords: COVID-19, Randomised controlled trial, Protocol, BCG vaccine, NSEs/Non-specific effects of vaccines, Heterologous effects of vaccines, Health care workers, Pandemic, Immune training.

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