Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer
ConclusionThis manuscript serves as the formal statistical analysis plan (version 1.0) for the SCOPE randomized controlled trial. The statistical analysis plan was completed on 6 April 2021.Trial registrationClinicalTrials.govNCT03436290. Registered on 16 February 2018 (Source: Trials)
Source: Trials - April 29, 2021 Category: Research Source Type: clinical trials

Nirsevimab MELODY Phase III Trial Met Primary Endpoint of Reducing RSV Lower Respiratory Tract Infections in Healthy Infants
26 April 2021 -- The MELODY Phase III trial for nirsevimab met its primary endpoint of a statistically significant reduction in the incidence of medically attended lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 26, 2021 Category: Pharmaceuticals Source Type: clinical trials

Statistical analysis plan for the COMPARE trial: a 3-arm randomised controlled trial comparing the effectiveness of Constraint-induced Aphasia Therapy Plus and Multi-modality Aphasia Therapy to usual care in chronic post-stroke aphasia (COMPARE)
DiscussionThis trial will provide relative effectiveness data for two common interventions for people with chronic post-stroke aphasia, and highlight possible differential effects based on aphasia severity. Together with the health economic analysis data, the results will enable more informed personalised prescription for aphasia therapy after stroke.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12615000618550. Registered on 15 June 2016 (Source: Trials)
Source: Trials - April 23, 2021 Category: Research Source Type: clinical trials

Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPO 2 CH): statistical analysis plan of a randomised controlled multicentre superiority trial
DiscussionThe results of the EPO2CH trial will determine if the EPO2CH bundle is effective to prevent SSI incidence for patients undergoing elective abdominal surgery. Details of the statistical analysis are described in this Statistical Analysis Plan (SAP).Trial registrationRegistration number: Dutch Trial Register TrialNL5572. Registered on March 3, 2016.SAP version: V1.0, January 8, 2020. This SAP has been written based on study protocol V10. (Source: Trials)
Source: Trials - April 21, 2021 Category: Research Source Type: clinical trials

The UPTAKE study: implications for the future of COVID-19 vaccination trial recruitment in UK and beyond
ConclusionsIn order to have a vaccination that is generalisable to the entire population, greater work needs to be done in engaging a diverse cohort of participants. Public health campaigns need to be targeted in improving trial recruitment rates for the elderly, BAME community and the less educated rural population. (Source: Trials)
Source: Trials - April 20, 2021 Category: Research Source Type: clinical trials

A randomised, double-blind, placebo-controlled, pilot trial of intravenous plasma purified alpha-1 antitrypsin for SARS-CoV-2-induced Acute Respiratory Distress Syndrome: a structured summary of a study protocol for a randomised, controlled trial
AbstractObjectivesThe primary objective is to demonstrate that, in patients with PCR-confirmed SARS-CoV-2 resulting in Acute Respiratory Distress Syndrome (ARDS), administration of 120mg/kg of body weight of intravenous Prolastin ®(plasma-purified alpha-1 antitrypsin) reduces circulating plasma levels of interleukin-6 (IL-6). Secondary objectives are to determine the effects of intravenous Prolastin® on important clinical outcomes including the incidence of adverse events (AEs) and serious adverse events (SAEs).Trial designPhase 2, randomised, double-blind, placebo-controlled, pilot trial.ParticipantsThe study will...
Source: Trials - April 19, 2021 Category: Research Source Type: clinical trials

Clinical, microbiological, and immunological effects of systemic probiotics in periodontal treatment: study protocol for a randomized controlled trial
AbstractBackgroundThe association of scaling and root planing (SRP) with systemic metronidazole (MTZ) plus amoxicillin (AMX) has shown to be an effective treatment protocol, particularly for periodontitis stages III and IV, generalized. More recently, probiotics have also been suggested as a promising adjunctive treatment for periodontal diseases due to their antimicrobial and anti-inflammatory properties. Therefore, the aim of this randomized clinical trial (RCT) is to evaluate the clinical, microbiological, and immunological effects of probiotics as adjuncts to SRP alone or with MTZ+AMX in the treatment of periodontitis....
Source: Trials - April 15, 2021 Category: Research Source Type: clinical trials

Adherence to participant flow diagrams in trials on postoperative pain management after total hip and knee arthroplasty: a methodological review
ConclusionsAdherence to participant flow diagrams for RCTs has increased significantly over time. Still, there is room for improvement of adequate reporting of flow diagrams, to increase transparency of trials details. (Source: Trials)
Source: Trials - April 14, 2021 Category: Research Source Type: clinical trials

Kiniksa Announces Positive Results for Mavrilimumab Phase 2 Trial in Non-Mechanically Ventilated Severe COVID-19 Patients
Primary endpoint achieved: the proportion of patients alive and free of mechanical ventilation at Day 29 was 12.3 percentage points higher with mavrilimumab versus placebo (p=0.1224 met predefined statistical threshold of p
Source: Drugs.com - Clinical Trials - April 12, 2021 Category: Pharmaceuticals Source Type: clinical trials

Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesThe primary objective of MATIS is to determine the efficacy of ruxolitinib (RUX) or fostamatinib (FOS) compared to standard of care (SOC) with respect to reducing the proportion of hospitalised patients progressing from mild or moderate to severe COVID-19 pneumonia.Secondary objectives, at 14 and 28 days, are to:Determine the efficacy of RUX or FOS to reduce mortalityDetermine the efficacy of RUX or FOS to reduce the need for invasive ventilation or ECMODetermine the efficacy of RUX or FOS to reduce the need for non-invasive ventilationDetermine the efficacy of RUX or FOS to reduce the proportion of parti...
Source: Trials - April 12, 2021 Category: Research Source Type: clinical trials

Adding a smartphone app to global postural re-education to improve neck pain, posture, quality of life, and endurance in people with nonspecific neck pain: a randomized controlled trial
ConclusionWhen a workplace assessment and management could not be as part of any intervention, adding a smartphone app to GPR for NP may be an appropriate tool to administer a home and work exercise program resulting in elevating pain and disability, as well as improving FHP and endurance.Trial registrationCurrent Controlled Trials using the UMIN-RCT websiteUMIN000039720. Retrospectively registered on January 9, 2020. (Source: Trials)
Source: Trials - April 12, 2021 Category: Research Source Type: clinical trials

Supporting Parents & amp; Kids Through Lockdown Experiences (SPARKLE) : A digital parenting support app implemented in an ongoing general population cohort study during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesThe COVID-19 related lockdowns and distancing measures have presented families with unprecedented challenges. A UK-wide cohort study tracking changes in families ’ mental health since early lockdown (Co-SPACE) found a significant rise in primary school-aged children’s behaviour problems and associated family-related stress. Three-quarters of parents in Co-SPACE also reported wanting extra support. In SPARKLE, we will examine whether providing Co-SPACE fa milies with a smartphone application delivering information and parenting support,Parent Positive, can reverse the negative effects of the pa...
Source: Trials - April 10, 2021 Category: Research Source Type: clinical trials

Primary Care implementation of Germ Defence, a digital behaviour change intervention to improve household infection control during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesTo examine the effectiveness of randomising dissemination of the Germ Defence behaviour change website via GP practices across England UK.Trial designA two-arm (1:1 ratio) cluster randomised controlled trial implementing Germ Defence via GP practices compared with usual care.ParticipantsSetting: All Primary care GP practices in England. Participants: All patients aged 16 years and over who were granted access by participating GP practices.Intervention and comparatorIntervention: We will ask staff at GP practices randomised to the intervention arm to share the weblink to Germ Defence with all adult patient...
Source: Trials - April 9, 2021 Category: Research Source Type: clinical trials

Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial
AbstractObjectivesThe primary objective is to determine the effect of a daily dose of ivermectin administered in three consecutive days to non-severe COVID-19 patients with no more than 96 hours of symptoms, on the detection of SARS-CoV-2 RNA by PCR from nasopharyngeal swabs at day seven post-treatment initiation.The secondary objectives are:To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab on days 4, 7, 14 and 21 post-treatment initiationTo assess the efficacy of ivermectin on the improvement of symptomsTo assess the proportion of seroconversions at day 21To assess the saf...
Source: Trials - April 9, 2021 Category: Research Source Type: clinical trials

Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0 –2-month-old low birth weight infants in India—the “ProSPoNS” Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial
DiscussionThis adequately powered and well-designed trial would conclusively answer the question whether probiotics can prevent neonatal sepsis in the high-risk group of low birth weight infants as indicated by a pilot study in 1340 LBW infants, evidence from systematic reviews of hospital-based studies, and a primary study on healthy newborns in Orissa. Results of the study would be generalizable to India and other low –middle-income countries.Trial registrationClinical Trial Registry of India (CTRI)CTRI/2019/05/019197. Registered on 16 May 2019 (Source: Trials)
Source: Trials - April 1, 2021 Category: Research Source Type: clinical trials

Design and implementation of botulinum toxin on cricopharyngeal dysfunction guided by a combination of catheter balloon, ultrasound, and electromyography (BECURE) in patients with stroke: study protocol for a randomized, double-blinded, placebo-controlled trial
This study will clarify whether BTX injection into the cricopharyngeal muscle can be effective and safe for patients with stroke and CPD.Trial registrationChinese Clinical Trial Register (ChiCTR1900025562). Registered on September 1, 2019. (Source: Trials)
Source: Trials - March 31, 2021 Category: Research Source Type: clinical trials

CytoDyn ’s Leronlimab Decreased Mortality at 14 Days by 82% With Statistically Significant P-Value of 0.0233 Amongst Critically Ill COVID-19 Patients
VANCOUVER, Washington, March 30, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ( " CytoDyn " or the " Company " ), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - March 30, 2021 Category: Pharmaceuticals Source Type: clinical trials

Peritoneal flap for lymphocele prophylaxis following robotic-assisted laparoscopic radical prostatectomy with pelvic lymph node dissection: study protocol and trial update for the randomized controlled PELYCAN study
DiscussionThe PELYCAN study is designed to assess whether the application of a peritoneal flap during RARP reduces the rate of symptomatic lymphoceles, as compared with the standard operation technique. In case of superiority of the intervention, this peritoneal flap may be suggested as a new standard of care.Trial registrationGerman Clinical Trials RegisterDRKS00016794. Registered on 14 May 2019. (Source: Trials)
Source: Trials - March 29, 2021 Category: Research Source Type: clinical trials

Per-protocol analysis of the ZINC trial for HIV disease among alcohol users
ConclusionsOverall, high adherence to zinc was associated with a lower VACS score, but confidence intervals were wide and crossed 0. Further studies with a larger sample size are needed to quantify the benefits of zinc supplementation in this population.Trial registrationClinicalTrials.govNCT01934803. Registered on August 30, 2013 (Source: Trials)
Source: Trials - March 23, 2021 Category: Research Source Type: clinical trials

Role of the active cycle of breathing technique combined with phonophoresis for the treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a preliminary randomized controlled trial
This study introduces a combination of active cycle of breathing techniques and phonophoresis to explore the impact of these interventions on patients hospitalized with COPD. If this combined intervention is shown to be effective, it may prove to be a better treatment for patients with COPD.Trial registrationThe trial was registered prospectively on the Chinese Clinical Trial Registry on 24 December 2019.ClinicalTrials.govChiCTR1900028506. Registered on December 2019. (Source: Trials)
Source: Trials - March 23, 2021 Category: Research Source Type: clinical trials

Prophylactic Antibiotic Regimens In Tumor Surgery (PARITY): a multi-center randomized controlled study comparing alternative antibiotic regimens in patients undergoing tumor resections with endoprosthetic replacements —a statistical analysis plan
This article describes the statistical analysis plan for the PARITY trial.Methods/designThe PARITY trial is an ongoing multi-center, blinded parallel two-arm randomized controlled trial (RCT) of 600 participants who have been diagnosed with a primary bone tumor, a soft tissue sarcoma that has invaded the bone or oligometastatic bone disease of the femur or tibia that requires surgical resection and endoprosthetic reconstruction. This article describes the overall analysis principles, including how participants will be included in each analysis, the presentation of results, adjustments for covariates, the primary and second...
Source: Trials - March 22, 2021 Category: Research Source Type: clinical trials

Recruitment patterns in a large international randomized controlled trial of perioperative care in cancer patients
ConclusionsAs a collaborative group, the PARITY investigators increased the pace of recruitment throughout the trial, likely by increasing the number of active sites. The longer time to start-up at international sites may be due to the complex governing regulations of pharmaceutical trials. Nevertheless, international sites should be considered essential as they recruited significantly more patients per month once active. The absence of research support personnel may lead to delays in the time to start-up. The results of the current study will provide guidance for choosing which sites to recruit for participation in future...
Source: Trials - March 20, 2021 Category: Research Source Type: clinical trials

Energy and protein intake in medical and geriatric inpatients with MEDPass versus conventional administration of oral nutritional supplements: study protocol for the randomized controlled MEDPass Trial
DiscussionTo our knowledge, this is the first randomized controlled trial assessing total energy and protein intake for the entire hospitalization period in patients receiving MEDPass versus conventional ONS administration. Thus, the MEDPass Trial will fill a gap and answer this relevant clinical question.Trial registrationClinicalTrials.govNCT03761680. Registered on 3 December 2018. Kofam.chSNCTP000003191. Registered on 15 October 2018 (Source: Trials)
Source: Trials - March 16, 2021 Category: Research Source Type: clinical trials

COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesThe main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization.Trial designHospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority.ParticipantsIncluded partic...
Source: Trials - March 16, 2021 Category: Research Source Type: clinical trials

Statistical consideration when adding new arms to ongoing clinical trials: the potentials and the caveats
ConclusionPlatform trials provide great opportunities for improving the efficiency of evaluating interventions. Although several statistical issues are present, there are a range of methods available that allow robust and efficient design and analysis of these trials. (Source: Trials)
Source: Trials - March 10, 2021 Category: Research Source Type: clinical trials

Pancreatitis - Microbiome As Predictor of Severity
Condition:   Acute Pancreatitis Intervention:   Diagnostic Test: Rectal and buccal swabs Sponsors:   University Medical Center Goettingen;   Department of Medicine II, University Hospital Rostock;   Medical Department II, Division of Gastroenterology, University Hospital of Leipzig;   Department of Medicine II, University Hospital, LMU Munich;   Department of Medicine I, University Hospi tal of Halle;   Department of Medicine A, University Medicine Greifswald;   Department of Medicine II, University Hospital rechts der Isar, Technical...
Source: ClinicalTrials.gov - March 2, 2021 Category: Research Source Type: clinical trials

UKCTOCS update: applying insights of delayed effects in cancer screening trials to the long-term follow-up mortality analysis
ConclusionsThe decision to alter the follow-up analysis for the primary outcome on the basis of new evidence and using new statistical methodology for long-term follow-up is novel and has implications beyond UKCTOCS. There is an urgent need for consensus building on how best to design, test, estimate and report mortality outcomes from long-term randomised cancer screening trials.Trial registrationISRCTN22488978. Registered on 6 April 2000. (Source: Trials)
Source: Trials - March 1, 2021 Category: Research Source Type: clinical trials

Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial
AbstractObjectivesThe primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days.Trial designREMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pr...
Source: Trials - March 1, 2021 Category: Research Source Type: clinical trials

Effect of patient-controlled intravenous analgesia combined with flurbiprofen axetil and dezocine on postoperative analgesia for lobectomy (EPIC-FAD): a trial protocol
DiscussionTrial did not begin to recruit. Participant recruitment start date is planned to be June 1, 2020. Approximate recruitment end date is May 31, 2021. If successful, the trial may shed light on the use of certain analgesic combinations in post-lobectomy pain control.Trial registrationChinese Clinical Trial RegistryChiCTR1800018563. Registered on September 25, 2018. (Source: Trials)
Source: Trials - March 1, 2021 Category: Research Source Type: clinical trials

“Include me if you can”—reasons for low enrollment of pediatric patients in a psychopharmacological trial
ConclusionsThe findings from this study add valuable information to the existing knowledge on reasons for low clinical trial recruitment rates in pediatric psychiatric populations. Low enrollment and high exclusion rates raise the question of whether such selective study populations are representative of clinical patient cohorts. Consequently, the generalizability of the results of such trials may be limited. The present findings will be useful in the development of improved recruitment strategies and may guide future research in establishing the measurement of representativeness to ensure enhanced external validity in psy...
Source: Trials - March 1, 2021 Category: Research Source Type: clinical trials

MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy (MEDIASTrial): a statistical analysis plan
DiscussionThe MEDIASTrial will determine if confirmatory mediastinoscopy can be omitted after tumour negative systematic endosonography in invasive mediastinal staging of patients with resectable NSCLC.Trial registrationNetherlands Trial RegisterNL6344/NTR6528. Registered on 2017 July 06 (Source: Trials)
Source: Trials - February 27, 2021 Category: Research Source Type: clinical trials

Tezepelumab is the First Biologic to Consistently and Significantly Reduce Exacerbations in Broad Population of Severe Asthma Patients
26 February 2021 -- Positive full results from the pivotal NAVIGATOR Phase III trial showed AstraZeneca and Amgen’s tezepelumab demonstrated a statistically significant and clinically meaningful1 reduction in the annualised asthma exacerbation... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - February 26, 2021 Category: Pharmaceuticals Source Type: clinical trials

Phase III Study of OT-101 in Treating Myopia
Condition:   Myopia, Progressive Interventions:   Drug: OT-101 Ophthalmic Solution;   Drug: Vehicle Sponsors:   Ocumension (Hong Kong) Limited;   ORA, Inc.;   Statistics & Data Corporation Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 25, 2021 Category: Research Source Type: clinical trials

Study of OT-101 in Treating Myopia
Condition:   Myopia, Progressive Interventions:   Drug: OT-101 Ophthalmic Solution;   Drug: Vehicle Sponsors:   Ocumension (Hong Kong) Limited;   ORA, Inc.;   Statistics & Data Corporation Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - February 25, 2021 Category: Research Source Type: clinical trials

Traditional Chinese medicine auricular point acupressure for the relief of pain, fatigue, and gastrointestinal adverse reactions after the injection of novel coronavirus-19 vaccines: a structured summary of a study protocol for a multicentre, three-arm, single-blind, prospective randomized controlled trial
AbstractObjectivesTo investigate if traditional Chinese medicine (TCM) auricular point acupressure (APA) can alleviate and (or) reduce the pain (including injection site pain, headache, other muscle and joint pain), fatigue, and gastrointestinal adverse reactions (including nausea, vomiting, diarrhea), after the injection of novel coronavirus-19 vaccines (NCVs).Trial designThe study is designed as a multicentre, parallel-group, three-arm, single-blind, prospective, randomized (1:1:1 ratio) study.ParticipantsMore than 360 participants will be recruited from healthy people who vaccinate NCVs in 5 community healthcare centres...
Source: Trials - February 25, 2021 Category: Research Source Type: clinical trials

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
DiscussionThe data generated from this trial will inform change in the policy of shifting task of screening of hypertension and atherosclerotic cardiovascular disease from doctors to nurses.Trial registrationPan African Trials Registry PACTR202001916873358. Registered on 6 October 2019 (Source: Trials)
Source: Trials - February 11, 2021 Category: Research Source Type: clinical trials