item: #1 of 42 id: cord-004168-rqd9b13s author: Daneman, Nick title: A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards date: 2020-01-15 words: 4773 flesch: 38 summary: On the one hand, merging non-ICU patients with ICU patients into a single trial could be viewed as mixing two heterogeneous populations together. For these calculations we estimated the 90day mortality for ward patients using outcome data from this ward pilot RCT, and we estimated the mortality for ICU patients from up-to-date data from the ongoing BALANCE main RCT. keywords: balance; hospital; icu; non; patients; pilot; rct; treatment; trial; ward cache: cord-004168-rqd9b13s.txt plain text: cord-004168-rqd9b13s.txt item: #2 of 42 id: cord-004339-7nwpic3d author: Rennie, Katherine J. title: Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction date: 2020-02-13 words: 8417 flesch: 39 summary: Keywords: Nasal septum, Nasal obstruction, Septoplasty, Turbinates, Mometasone furoate, Clinical trial, Cost-effectiveness, Process evaluation Background Septoplasty is surgery to straighten the nasal partition between the two nostrils (the septum). The estimation of a preference-based measure of health from the SF-36 The use of nasal spirometry as an objective measure of nasal septal deviation and the effectiveness of septal surgery Use of peak nasal inspiratory flowmetry and nasal decongestant to evaluate outcome of septoplasty with radiofrequency coblation of the inferior turbinate The accuracy and reproducibility of rhinospirometry in detecting flow asymmetry in a nasal cavity model The value of bilateral simultaneous nasal spirometry in the assessment of patients undergoing septoplasty SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials Nasal septal surgery: evaluation of symptomatic and general health outcomes Patterns of treatment effects in subsets of patients in clinical trials Reporting attrition in randomised controlled trials Practice based, longitudinal, qualitative interview study of computerised evidence based guidelines in primary care The NAtional randomised controlled Trial of Tonsillectomy IN Adults (NATTINA): a clinical and cost-effectiveness study: study protocol for a randomised control trial Distributed decision making: the anatomy of decisions-in-action Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials Capturing users' experiences of participating in cancer trials Evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit A feasibility study incorporating a pilot randomised controlled trial of oral feeding plus pre-treatment gastrostomy tube versus oral feeding plus as-needed nasogastric tube feeding in patients undergoing chemoradiation for head and neck cancer (TUBE trial): study protocol The constant comparative method of qualitative analysis The quality of qualitative research. keywords: analysis; data; health; management; medical; months; nairos; nasal; nose; outcome; participants; patients; recruitment; septoplasty; study; surgery; treatment; trial cache: cord-004339-7nwpic3d.txt plain text: cord-004339-7nwpic3d.txt item: #3 of 42 id: cord-004404-s6udpwxq author: Seifi, Najmeh title: Effects of synbiotic supplementation on energy and macronutrients homeostasis and muscle wasting of critical care patients: study protocol and a review of previous studies date: 2020-02-24 words: 4643 flesch: 37 summary: key: cord-004404-s6udpwxq authors: Seifi, Najmeh; Safarian, Mohammad; Nematy, Mohsen; Rezvani, Reza; Khadem-Rezaian, Majid; Sedaghat, Alireza title: Effects of synbiotic supplementation on energy and macronutrients homeostasis and muscle wasting of critical care patients: study protocol and a review of previous studies date: 2020-02-24 journal: Trials DOI: 10.1186/s13063-020-4136-3 sha: doc_id: 4404 cord_uid: s6udpwxq BACKGROUND: An extreme and persistent dysbiosis occurs among critically ill patients, regardless of the heterogeneity of disease. Gut microbiota in health and disease Current understanding of the human microbiome The role of the microbiome in human health and disease: an introduction for clinicians The impact of probiotics' administration on glycemic control, body composition, gut microbiome, mitochondria, and other hormonal signals in adolescents with prediabetesa randomized, controlled trial study protocol Gut microbiota: an integral moderator in health and disease Role of the microbiome, probiotics, and 'dysbiosis therapy' in critical illness The re-emerging role of the intestinal microflora in critical illness and inflammation: why the gut hypothesis of sepsis syndrome will not go away Muscle wasting: the gut microbiota as a new therapeutic target? Gut barrier dysfunction and microbial translocation in cancer cachexia: a new therapeutic target Malnutrition in critically ill patients in intensive care units Association between malnutrition and clinical outcomes in the intensive care unit: a systematic review Association between malnutrition and 28-day mortality and intensive care length-ofstay in the critically ill: a prospective cohort study Diagnostic criteria for malnutrition-an ESPEN consensus statement Gut microbiota, nutrient sensing and energy balance Gut microbiota and energy balance: role in obesity Use of standard enteral formula versus enteric formula with prebiotic content in nutrition therapy: a randomized controlled study among neuro-critical care patients Microbial cell preparation in enteral feeding in critically ill patients: a randomized, doubleblind, placebo-controlled clinical trial Effect of a multispecies probiotic on inflammatory markers in critically ill patients: a randomized, double-blind, placebocontrolled trial Probiotic and synbiotic therapy in critical illness: a systematic review and meta-analysis The immune system bridges the gut microbiota with systemic energy homeostasis: focus on TLRs, mucosal barrier, and SCFAs Muscle loss: the new malnutrition challenge in clinical practice Restoring specific lactobacilli levels decreases inflammation and muscle atrophy markers in an acute leukemia mouse model Non digestible oligosaccharides modulate the gut microbiota to control the development of leukemia and associated cachexia in mice Synbiotic approach restores intestinal homeostasis and prolongs survival in leukaemic mice with cachexia Beneficial bacteria inhibit cachexia ESPEN guideline on clinical nutrition in the intensive care unit Effectiveness of continuous enteral nutrition versus intermittent enteral nutrition in intensive care patients: a systematic review Intermittent versus continuous feeding in critically ill adults Treatment of opioid-induced gut dysfunction Bacterial translocation: overview of mechanisms and clinical impact Gastric acid reduction leads to an alteration in lower intestinal microflora Probiotics in the critical care unit: fad, fact, or fiction? keywords: care; critical; energy; gut; homeostasis; icu; microbiota; muscle; nutrition; patients; protein; study; wasting cache: cord-004404-s6udpwxq.txt plain text: cord-004404-s6udpwxq.txt item: #4 of 42 id: cord-004450-daxz9yhp author: Haeberle, Helene title: Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study date: 2020-03-04 words: 5858 flesch: 36 summary: X a X a X a X a X a X a X a Fluid balance X a X a X a X a X a X a X a Transfusion of red blood cells X X X X X X X b X X X Transfusion of thrombocytes X X X X X X X b X X X Anticoagulation Infection X X X X X X X b X X X Anti-infective therapy X X X X X X X b X X X When possible, however, the patient or his legal representative is to be informed both in writing and verbally by the investigator before any study-specific procedure is Iloprost or NaCl 0.9% (control) X X X X X Clinical assessment including outcome X X X X X X X X X Laboratory testing X X X X X X X X Adverse/serious adverse event monitoring X X X X X X X Plasma biomarkers X X X X X X Barthel Index X X X X SOFA score keywords: acute; ards; day; effect; iloprost; injury; lung; patients; pulmonary; study; treatment; trial; ventilation cache: cord-004450-daxz9yhp.txt plain text: cord-004450-daxz9yhp.txt item: #5 of 42 id: cord-004515-x22q1f21 author: Pottecher, Julien title: Protocol for TRAUMADORNASE: a prospective, randomized, multicentre, double-blinded, placebo-controlled clinical trial of aerosolized dornase alfa to reduce the incidence of moderate-to-severe hypoxaemia in ventilated trauma patients date: 2020-03-18 words: 6820 flesch: 38 summary: The primary trial objective is to demonstrate a reduction in the incidence of moderate-to-severe hypoxaemia in severe trauma patients during the first 7 days from 45% to 30% by providing aerosolized dornase alfa as compared to placebo. This treatment may facilitate ventilator weaning, reduce the burden of trauma-induced lung inflammation and facilitate recovery and rehabilitation in severe trauma patients. keywords: alfa; analysis; blood; data; day; days; dna; dornase; hypoxaemia; incidence; injury; lung; patients; study; trauma; trial; variables cache: cord-004515-x22q1f21.txt plain text: cord-004515-x22q1f21.txt item: #6 of 42 id: cord-004646-zhessjqh author: Bawazeer, Mohammed title: Adjunct low-dose ketamine infusion vs standard of care in mechanically ventilated critically ill patients at a Tertiary Saudi Hospital (ATTAINMENT Trial): study protocol for a randomized, prospective, pilot, feasibility trial date: 2020-03-20 words: 7844 flesch: 38 summary: A concern was raised about the under-dosing of ketamine compared to ICU ketamine studies. This trial is a prospective, randomized, active controlled, open-label, pilot, feasibility study of adult ICU patients (> 14 years old) on MV. keywords: analysis; care; data; delirium; dose; icu; infusion; ketamine; patients; protocol; randomization; sedation; study; trial cache: cord-004646-zhessjqh.txt plain text: cord-004646-zhessjqh.txt item: #7 of 42 id: cord-012934-c6pbr64i author: Hao, Weiming title: Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial date: 2020-07-22 words: 5456 flesch: 38 summary: To evaluate the recovery of vestibular function, we set the recovery rates of the whole battery of vestibular function tests (SOT/caloric test/vHIT/VEMPs) as the primary outcome, which is the proportion of patients whose abnormal results of vestibular function tests at baseline recover to normal at 4-/8-week follow-up: in this study, we define a 10-dB PTA criterion as clinically significant difference based on a previous RCT [9] . For comparisons of recovery in 4 and 8 weeks from baseline, the recovery rates of vestibular function tests will be calculated by chi-squared tests, and logistic regression adjusts for potential confounders like age, initial PTA, the number of involved vestibular organs, MRI-IAC results, and other characteristics, while the numerical variables like UW of the caloric test, PTA, and scores in DHI, VAS-V, and VAS-T will be calculated by mixed-model with repeated measures analyses of variance (ANOVA), with group and time as fixed effects and subject as a random effect, controlling for the potential confounders. keywords: caloric; dysfunction; function; hearing; issnhl; loss; patients; recovery; study; test; trial; vestibular cache: cord-012934-c6pbr64i.txt plain text: cord-012934-c6pbr64i.txt item: #8 of 42 id: cord-029112-u507i0t0 author: Smith, Keisha title: A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial date: 2020-07-13 words: 20949 flesch: 39 summary: While the Investigator is not obligated to actively seek this information in former study patients, he or she may learn of an SAE through spontaneous reporting. key: cord-029112-u507i0t0 authors: Smith, Keisha; Pace, Amy; Ortiz, Stephan; Kazani, Shamsah; Rottinghaus, Scott title: A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial date: 2020-07-13 journal: Trials DOI: 10.1186/s13063-020-04548-z sha: doc_id: 29112 cord_uid: u507i0t0 OBJECTIVES: keywords: acute; alexion; alxn1210; amendment; bsc; complement; cov-305; covid-19; data; day; global; infection; information; infusion; intervention; investigator; lung; medical; patients; period; pregnancy; protocol; ravulizumab; sae; safety; study; time; treatment cache: cord-029112-u507i0t0.txt plain text: cord-029112-u507i0t0.txt item: #9 of 42 id: cord-030531-4uucx9ss author: Randremanana, Rindra Vatosoa title: An open-label, randomized, non-inferiority trial of the efficacy and safety of ciprofloxacin versus streptomycin + ciprofloxacin in the treatment of bubonic plague (IMASOY): study protocol for a randomized control trial date: 2020-08-17 words: 8052 flesch: 45 summary: The routine samples taken from trial patients will be labelled with a collection label which will not contain a patient trial identifier. The majority of plague patients are treated at the CSB level. keywords: bubonic; ciprofloxacin; clinical; daily; data; days; patients; plague; pneumonic; protocol; streptomycin; study; treatment; trial cache: cord-030531-4uucx9ss.txt plain text: cord-030531-4uucx9ss.txt item: #10 of 42 id: cord-031315-p7jb4gf2 author: Kong, Qing title: Efficacy and safety of Jia Wei Bushen Yiqi formulas as an adjunct therapy to systemic glucocorticoids on acute exacerbation of COPD: study protocol for a randomized, double-blinded, multi-center, placebo-controlled clinical trial date: 2020-09-03 words: 8386 flesch: 48 summary: Trial participants, care providers including attending physician and nurse, outcome assessors including PI and sub-PI, and data analysts will be blinded after the assignment of interventions. Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} Any modification to the protocol which may impact the conduct of the study and the potential benefit of the patients will be reported to ethic committee. keywords: chinese; clinical; copd; data; day; days; disease; exacerbation; group; participants; patients; prednisone; pulmonary; study; tcm; treatment; trial cache: cord-031315-p7jb4gf2.txt plain text: cord-031315-p7jb4gf2.txt item: #11 of 42 id: cord-032926-mrnsaexq author: Waitz, Markus title: Application of two different nasal CPAP levels for the treatment of respiratory distress syndrome in preterm infants—“The OPTTIMMAL-Trial”—Optimizing PEEP To The IMMAture Lungs: study protocol of a randomized controlled trial date: 2020-10-01 words: 6996 flesch: 41 summary: To The IMMAture Lungs: study protocol of a randomized controlled trial date: 2020-10-01 journal: Trials DOI: 10.1186/s13063-020-04660-0 sha: doc_id: 32926 cord_uid: mrnsaexq BACKGROUND: Local principal investigators and team members are required to participate in a pre-study meeting where details of study protocol, data collection, the application, and adjustments of PEEP will be discussed. keywords: cmh; cpap; data; infants; nasal; peep; pressure; preterm; protocol; study; treatment; ventilation cache: cord-032926-mrnsaexq.txt plain text: cord-032926-mrnsaexq.txt item: #12 of 42 id: cord-033331-giku34r9 author: Manrique-Saide, Pablo title: The TIRS trial: protocol for a cluster randomized controlled trial assessing the efficacy of preventive targeted indoor residual spraying to reduce Aedes-borne viral illnesses in Merida, Mexico date: 2020-10-08 words: 9926 flesch: 43 summary: Poorly designed evaluations, a historical lack of focus on quantifying intervention impact using epidemiological endpoints, and limited funding for large-scale randomized controlled trials with epidemiological endpoints have all contributed to the lack of rigorous, evidence-based, assessments of ABV vector control interventions [10, 15] . The analysis will adopt recently developed methods for cluster randomized vector control trials keywords: abv; aegypti; children; clusters; control; data; dengue; health; indoor; infection; insecticide; laboratory; spraying; study; surveillance; time; tirs; transmission; trial; vector; year; yucatan cache: cord-033331-giku34r9.txt plain text: cord-033331-giku34r9.txt item: #13 of 42 id: cord-033772-uzgya4k9 author: Strömmer, Sofia title: Engaging adolescents in changing behaviour (EACH-B): a study protocol for a cluster randomised controlled trial to improve dietary quality and physical activity date: 2020-10-15 words: 9094 flesch: 44 summary: Comparable effect sizes have been considered in other health interventions as meaningful in terms of change in health behaviours, and our level of 0.25 SDs falls in the mid-range of effect sizes reported in a meta-synthesis of meta-analyses of behaviour change interventions in the general population [57] . Of the schools recruited, 25 will therefore be intervention schools where two classes of Year 8 students will complete the LifeLab module, be offered support from teachers trained in skills to support health behaviour change and receive the digital intervention. keywords: activity; adolescents; behaviour; change; data; diet; health; intervention; lifelab; outcomes; quality; research; schools; southampton; students; support; trial cache: cord-033772-uzgya4k9.txt plain text: cord-033772-uzgya4k9.txt item: #14 of 42 id: cord-034257-kl2ccmz5 author: de Jonge, Jeroen C. title: PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke—statistical analysis plan of a randomised, open, phase III, clinical trial with blinded outcome assessment date: 2020-10-26 words: 3734 flesch: 47 summary: Rationale and design of a randomised, open, phase III, clinical trial with blinded outcome assessment Contemporary outcome measures in acute stroke research Improving the efficiency of stroke trials Statistical analysis of the primary outcome in acute stroke trials Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations None. Medical complications after stroke Characteristic adverse events and their incidence among patients participating in acute ischemic stroke trials Development and internal validation of a prediction rule for post-stroke infection and poststroke pneumonia in acute stroke patients Post-stroke infection: a systematic review and meta-analysis Therapeutic hypothermia in acute ischemic stroke Impact of fever on outcome in patients with stroke and neurologic injury: a comprehensive meta-analysis Effect of hyperthermia on prognosis after acute ischemic stroke Dysphagia after stroke: incidence, diagnosis, and pulmonary complications Temporal profile of body temperature in acute ischemic stroke: relation to infarct size and outcome Poststroke dysphagia: a review and design considerations for future trials Route of feeding as a proxy for dysphagia after stroke and the effect of transdermal glyceryl trinitrate: data from the efficacy of nitric oxide in stroke randomised controlled trial An early rise in body temperature is related to unfavorable outcome after stroke: data from the PAIS study Antibiotic therapy for preventing infections in patients with acute stroke The Paracetamol (Acetaminophen) keywords: analysis; data; days; mrs; outcome; patients; stroke; treatment; trial cache: cord-034257-kl2ccmz5.txt plain text: cord-034257-kl2ccmz5.txt item: #15 of 42 id: cord-253129-v5lck9l7 author: Kim, Kyeong Tae title: Model-based PEEP titration versus standard practice in mechanical ventilation: a randomised controlled trial date: 2020-02-01 words: 8906 flesch: 51 summary: The clinical data are collected by research nurses in the ICU and mechanical ventilation data and oxygenation (bedside monitor) data will be collected by researchers from the UC. Positive end-expiratory pressure (PEEP) at minimum respiratory elastance during mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS) may improve patient care and outcome. keywords: clinical; cure; data; elastance; lung; patients; peep; pressure; rct; recruitment; study; trial; ventilation cache: cord-253129-v5lck9l7.txt plain text: cord-253129-v5lck9l7.txt item: #16 of 42 id: cord-255101-l5ssz750 author: Daval, Mary title: Efficacy of local budesonide therapy in the management of persistent hyposmia in COVID-19 patients without signs of severity: A structured summary of a study protocol for a randomised controlled trial date: 2020-07-20 words: 8952 flesch: 48 summary: Tout EIG doit être notifié au promoteur :  à partir de la date de signature du consentement,  jusqu'à la fin de participation à la recherche, mais également sans limitation de temps, lorsque l'EIG est susceptible d'être dû au médicament. Objectif principal: Evaluer l'efficacité du budésonide en traitement local intranasal (lavage de nez), en complément de la rééducation olfactive, dans la prise en charge de la perte d'odorat de patients COVID-19 sans signes de gravité et présentant une persistance de l'hyposmie 30 jours après le début des symptômes. keywords: budésonide; cas; cette; covid-19; d'un; dans; des; données; début; est; jours; l'étude; les; nez; non; olfactive; par; pas; patients; pour; promoteur; que; qui; recherche; sans; sera; seront; signes; sur; symptômes; traitement; une cache: cord-255101-l5ssz750.txt plain text: cord-255101-l5ssz750.txt item: #17 of 42 id: cord-263628-ac9gld5l author: Sivapalan, Pradeesh title: Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan date: 2020-10-20 words: 3492 flesch: 46 summary: Data is analyzed using intention-to-treat (ITT) principles, and main analyses will also be subject to modified ITT analysis and per protocol analysis. Data will be analyzed using intention-to-treat (ITT) principles and main analyses will also be subject to modified ITT analysis (started but not completed the study) and per protocol analysis (completed all interventions). keywords: analysis; data; days; oxygen; patients; study; test; treatment; trial cache: cord-263628-ac9gld5l.txt plain text: cord-263628-ac9gld5l.txt item: #18 of 42 id: cord-282474-74273qgk author: Roehrig, Stefan title: Flow controlled ventilation in Acute Respiratory Distress Syndrome associated with COVID-19: A structured summary of a study protocol for a randomised controlled trial date: 2020-09-11 words: 2881 flesch: 51 summary: key: cord-282474-74273qgk authors: Roehrig, Stefan; Ait Hssain, Ali; Shallik, Nabil Al Hamid; Elsaid, Ingi Mohamed A.; Mustafa, Salma Faisal; Smain, Osama A. M.; Molokhia, Ashraf Abdulla; Lance, Marcus D. title: Flow controlled ventilation in Acute Respiratory Distress Syndrome associated with COVID-19: A structured summary of a study protocol for a randomised controlled trial date: 2020-09-11 journal: Trials DOI: 10.1186/s13063-020-04708-1 sha: doc_id: 282474 cord_uid: 74273qgk OBJECTIVES: This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients (pressure control ventilation) in patients suffering from ARDS associated with COVID-19. keywords: ards; data; flow; patients; pressure; study; ventilation cache: cord-282474-74273qgk.txt plain text: cord-282474-74273qgk.txt item: #19 of 42 id: cord-286237-x6dr6rsh author: Maes, Bastiaan title: Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial date: 2020-06-03 words: 11261 flesch: 42 summary: Ethical and legal aspects The study will be conducted cfr the latest version of the ICH E6 (R2) GCP guidelines, creating a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical studies that provides assurance that the data and reported results are accurate and that the rights, integrity and confidentiality of study subjects are protected. Monitoring services will consist of the following (non-exhaustive list): -review of informed consents and the followed process -check on recruitment status -checking for protocol deviations/violations -checking GCP compatibility -check on safety reporting compliance -IMP handling and storage -review of study data … This study can be inspected at any time by regulatory agencies during or after completion of the study. keywords: anakinra; blood; care; covid-19; cytokine; data; days; hospital; il-1; il-6; improvement; injection; investigator; patients; siltuximab; study; subject; time; tocilizumab; treatment; trial; use cache: cord-286237-x6dr6rsh.txt plain text: cord-286237-x6dr6rsh.txt item: #20 of 42 id: cord-288344-8dar2p3j author: Yang, Xiaoyu title: The rescue intervention strategy for asthma patients under severe air pollution: a protocol for a single-centre prospective randomized controlled trial date: 2020-11-04 words: 4683 flesch: 49 summary: Studies have shown that air pollution is a high-risk factor for asthma exacerbations. The primary outcome is the frequency of asthma exacerbations per year. keywords: air; asthma; data; exacerbations; group; intervention; participants; pollution; study cache: cord-288344-8dar2p3j.txt plain text: cord-288344-8dar2p3j.txt item: #21 of 42 id: cord-292544-m7jyydf1 author: Grau-Pujol, Berta title: Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial date: 2020-07-29 words: 4577 flesch: 44 summary: Study participant flowchart The occurrence of an AE or SAE may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by the study monitor. keywords: cov-2; covid-19; group; healthcare; hydroxychloroquine; prep; sars; study; workers cache: cord-292544-m7jyydf1.txt plain text: cord-292544-m7jyydf1.txt item: #22 of 42 id: cord-293440-qoo2t1wt author: Wilkinson, Tom title: ACCORD: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients: A structured summary of a study protocol for a randomised controlled trial date: 2020-07-31 words: 1866 flesch: 45 summary: Stage 1: To evaluate the safety and efficacy of candidate agents as add-on therapies to standard of care (SoC) in patients hospitalised with COVID-19 in a screening stage. Stage 2: To confirm the efficacy of candidate agents selected on the basis of evidence from Stage 1 in patients hospitalised with COVID-19 in an expansion stage. keywords: candidate; covid-19; protocol; stage; trial cache: cord-293440-qoo2t1wt.txt plain text: cord-293440-qoo2t1wt.txt item: #23 of 42 id: cord-300465-19euup51 author: Paniagua-Avila, Alejandra title: Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial date: 2020-06-09 words: 4900 flesch: 35 summary: Normas de Atencion Salud Integral para primero y segundo nivel Evaluation of a pilot hypertension management programme for Guatemalan adults Measurement of blood pressure in humans: a scientific statement from the Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda Effect of a community health worker-led multicomponent intervention on blood pressure control in low-income patients in Argentina: a randomized clinical trial Comprehensive approach for hypertension control in low-income populations: rationale and study design for the hypertension control program in argentina RE-AIM Planning and evaluation framework: adapting to new science and practice with a 20-year review Using the Practical, Robust Implementation and Sustainability Model (PRISM) to qualitatively assess multilevel contextual factors to help plan, implement, evaluate, and disseminate health services programs Evaluating the public health impact of health promotion interventions: the RE-AIM framework Cost-effectiveness analysis alongside clinical trials II-An ISPOR Good Research Practices Task Force report Intervention costs will include fixed costs such as education of health providers and salary of auxiliary nurses, and variable costs such as electronic BP monitors. keywords: care; control; health; hypertension; implementation; intervention; nurses; participants; patients; program; study cache: cord-300465-19euup51.txt plain text: cord-300465-19euup51.txt item: #24 of 42 id: cord-302448-2r4rtixg author: Kharma, Nadir title: Anticoagulation in critically ill patients on mechanical ventilation suffering from COVID-19 disease, The ANTI-CO trial: A structured summary of a study protocol for a randomised controlled trial date: 2020-09-07 words: 1837 flesch: 47 summary: key: cord-302448-2r4rtixg authors: Kharma, Nadir; Roehrig, Stefan; Shible, Ahmed Atef; Elshafei, Moustafa Sayed; Osman, Dema; Elsaid, Ingi Mohamed; Mustafa, Salma Faisal; Aldabi, Asjad; Smain, Osamah A.M.; Lance, Marcus D. title: Anticoagulation in critically ill patients on mechanical ventilation suffering from COVID-19 disease, The ANTI-CO trial: A structured summary of a study protocol for a randomised controlled trial date: 2020-09-07 journal: Trials DOI: 10.1186/s13063-020-04689-1 sha: doc_id: 302448 cord_uid: 2r4rtixg OBJECTIVES: To assess the effect of anticoagulation with bivalirudin administered intravenously on gas-exchange in patients with COVID-19 and respiratory failure using invasive mechanical ventilation. The protocol is registered before starting subject recruitment under the title: “Anticoagulation in patients suffering from COVID-19 disease. keywords: bivalirudin; data; group; patients; protocol; treatment cache: cord-302448-2r4rtixg.txt plain text: cord-302448-2r4rtixg.txt item: #25 of 42 id: cord-303322-d69o3z8d author: Chang, Anne B title: Randomized placebo-controlled trial on azithromycin to reduce the morbidity of bronchiolitis in Indigenous Australian infants: rationale and protocol date: 2011-04-14 words: 5437 flesch: 33 summary: Indeed, Indigenous infants are more likely to receive antibiotics for an episode of pneumonia diagnosed during an admission for bronchiolitis than non-Indigenous infants nursed in the same paediatric unit [6] . Bronchiolitis in Indigenous infants is more severe than bronchiolitis in non-Indigenous infants [6] . keywords: azithromycin; bronchiolitis; children; data; hospital; illness; infants; months; placebo; pneumoniae; study; term cache: cord-303322-d69o3z8d.txt plain text: cord-303322-d69o3z8d.txt item: #26 of 42 id: cord-310169-yn7pu9i8 author: Marietta, Marco title: Randomised controlled trial comparing efficacy and safety of high versus low Low-Molecular Weight Heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol date: 2020-06-26 words: 2955 flesch: 50 summary: [TE]. 4. a. Continuous Positive Airway Pressure (Cpap) or Non-Invasive Ventilation (NIV) or b. IMV in patients who at randomisation were receiving standard oxygen therapy. 5. IMV in patients who at randomisation were receiving non-invasive mechanical ventilation. keywords: bleeding; group; patients; randomisation; study; time cache: cord-310169-yn7pu9i8.txt plain text: cord-310169-yn7pu9i8.txt item: #27 of 42 id: cord-311697-2w9qody4 author: Liu, Xi title: Efficacy of chloroquine versus lopinavir/ritonavir in mild/general COVID-19 infection: a prospective, open-label, multicenter, randomized controlled clinical study date: 2020-07-08 words: 3938 flesch: 45 summary: The safety analysis group will include participants who received study drugs at least once and have post-dose safety evaluation data. This is a prospective, open-label, randomized controlled, multicenter clinical study. keywords: chloroquine; covid-19; days; follow; group; ritonavir; study; time; treatment; trial cache: cord-311697-2w9qody4.txt plain text: cord-311697-2w9qody4.txt item: #28 of 42 id: cord-315149-71bmj5il author: Caballero Bermejo, Antonio F. title: Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial date: 2020-09-16 words: 11238 flesch: 40 summary: Also, it will stick to the recommendations given by the consensus documents of the scientific journals3,4 to improve reliability and value of medical research literature by promoting transparent and accurate reporting of clinical research studies. The Principal Investigator may decide to conduct final analysis of study data at any time, even while some subjects may remain in long-term follow-up. keywords: clinical; consent; covid-19; data; dose; failure; following; il6; intervention; investigator; patients; protocol; sarilumab; soc; sponsor; study; treatment; trial cache: cord-315149-71bmj5il.txt plain text: cord-315149-71bmj5il.txt item: #29 of 42 id: cord-315175-51wuz9i1 author: Kaddam, Lamis title: Potential Role of Acacia Senegal (Gum Arabic) as Immunomodulatory Agent among newly diagnosed COVID 19 Patients: A structured summary of a protocol for a randomised, controlled, clinical trial date: 2020-09-05 words: 2446 flesch: 43 summary: Gum Arabic anti-inflammatory effect has been investigated in clinical trials (10, 12) . Gum Arabic has anti-inflammatory effect which has been investigated in various diseases and conditions. keywords: acacia; arabic; covid-19; disease; effect; gum; patients cache: cord-315175-51wuz9i1.txt plain text: cord-315175-51wuz9i1.txt item: #30 of 42 id: cord-316666-qif1k62t author: Ghati, Nirmal title: Atorvastatin and Aspirin as Adjuvant Therapy in Patients with SARS-CoV-2 Infection: A structured summary of a study protocol for a randomised controlled trial date: 2020-10-30 words: 4405 flesch: 39 summary: Patients with early discharge (due to clinical improvement and patient's preference for home isolation) will be followed up by alternate day telephonic contact till 10 th day of drug regimen. The safety of these drugs in COVID-19 patients will also be evaluated. keywords: aspirin; atorvastatin; covid-19; days; disease; group; infection; patients; statins; study; therapy; trial cache: cord-316666-qif1k62t.txt plain text: cord-316666-qif1k62t.txt item: #31 of 42 id: cord-322534-eikz07zz author: Allahyari, Abolghasem title: Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: a structured summary of a study protocol for a randomised controlled trial date: 2020-06-26 words: 1251 flesch: 49 summary: Patients with acute lymphoid and myeloid leukemias in the first line treated with curative intent, patients with high-grade non-Hodgkin's lymphoma treated with leukemia protocols and patients with non-metastatic breast and colon cancer in the first line of treatment will enter the study. key: cord-322534-eikz07zz authors: Allahyari, Abolghasem; Rahimi, Hossein; Khadem-Rezaiyan, Majid; Mozaheb, Zahra; Seddigh-Shamsi, Mohsen; Bary, Alireza; Kamandi, Mostafa; Azimi, Sajad Ataei; HasanAbadi, Saeed Eslami; Noferesti, Alireza; Shariatmaghani, Somayeh Sadat; Rafatpanah, Houshang; Khatami, Shohreh; Imani, Afshin Jabbar; Mortazi, Hassan; Nodeh, Mohammad Moeini title: Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: a structured summary of a study protocol for a randomised controlled trial date: 2020-06-26 journal: Trials DOI: 10.1186/s13063-020-04485-x sha: doc_id: 322534 cord_uid: eikz07zz OBJECTIVES: keywords: covid-19; patients; protocol; trial cache: cord-322534-eikz07zz.txt plain text: cord-322534-eikz07zz.txt item: #32 of 42 id: cord-324786-8k81jetq author: Chang, Anne B title: Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial date: 2012-08-31 words: 5675 flesch: 38 summary: key: cord-324786-8k81jetq authors: Chang, Anne B; Grimwood, Keith; Robertson, Colin F; Wilson, Andrew C; van Asperen, Peter P; O’Grady, Kerry-Ann F; Sloots, Theo P; Torzillo, Paul J; Bailey, Emily J; McCallum, Gabrielle B; Masters, Ian B; Byrnes, Catherine A; Chatfield, Mark D; Buntain, Helen M; Mackay, Ian M; Morris, Peter S title: Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial date: 2012-08-31 journal: Trials DOI: 10.1186/1745-6215-13-156 sha: doc_id: 324786 cord_uid: 8k81jetq BACKGROUND: Despite bronchiectasis being increasingly recognised as an important cause of chronic respiratory morbidity in both indigenous and non-indigenous settings globally, high quality evidence to inform management is scarce. Indeed, no published RCTs addressing the treatment of bronchiectasis exacerbations in children exist. keywords: acid; antibiotic; azithromycin; bronchiectasis; children; clavulanic; cough; data; day; exacerbations; lung; non; placebo; study cache: cord-324786-8k81jetq.txt plain text: cord-324786-8k81jetq.txt item: #33 of 42 id: cord-330573-rr2r8245 author: Stockmann, Helena title: CytoResc – “CytoSorb” Rescue for critically ill patients undergoing the COVID-19 Cytokine Storm: A structured summary of a study protocol for a randomized controlled trial date: 2020-06-26 words: 1703 flesch: 48 summary: Approximately 8 - 10 % of COVID-19 patients present with a serious clinical course and need for hospitalization, 8% of hospitalized patients need ICU-treatment. However, in a number of patients a severe hyperinflammatory response with excessively elevated proinflammatory cytokines causes vasoplegic shock resistant to vasopressor therapy. keywords: cytosorb; patients; protocol; study; trial cache: cord-330573-rr2r8245.txt plain text: cord-330573-rr2r8245.txt item: #34 of 42 id: cord-331487-jh34klbg author: Sivapalan, Pradeesh title: Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial date: 2020-06-10 words: 6407 flesch: 42 summary: The length of hospitalisation is observed to be relatively long, 10-15 days (3) , which in itself is a problem as hospitals can quickly reach the maximum capacity for hospitalisation and the proportion of patients who become critically ill have, based on the observations reported so far, had a mortality rate of> 60% (4), and overall mortality for admitted patients in China with COVID-19 infection is apparently unusually high for viral respiratory tract infections with an estimate of 25% (2). Annual monitoring after 5 years of treatment is recommended, however in risk patients initially annual control, see also Chloroquine derivatives (inflammatory rheumatic diseases), side effects. keywords: azithromycin; consent; covid-19; data; days; group; hydroxychloroquine; information; intervention; medication; patients; project; study; treatment; trial cache: cord-331487-jh34klbg.txt plain text: cord-331487-jh34klbg.txt item: #35 of 42 id: cord-334667-0cah15lg author: Arabi, Yaseen M. title: Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial date: 2020-01-03 words: 3838 flesch: 45 summary: To overcome these challenges, we designed the MIRACLE trial as a recursive two-stage adaptive trial, which is a relatively new method for group sequential trials The trial is designed as a recursive, two-stage, group sequential randomized trial. keywords: analysis; days; group; patients; stage; study; table; trial cache: cord-334667-0cah15lg.txt plain text: cord-334667-0cah15lg.txt item: #36 of 42 id: cord-334956-pi8ifpcy author: Chan, Raymond Javan title: Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in breast cancer post-treatment follow-up: a study protocol for a phase II randomised controlled trial (the EMINENT trial) date: 2020-10-15 words: 5659 flesch: 36 summary: The program includes the National Cancer Nursing Education (EdCAN) learning module on survivorship, related literature, didactic presentations, and roleplay covering: basic concepts of quality cancer survivorship care, components of a high-quality treatment summary and survivorship care plan; provision of self-management support (including collaborative goal setting; motivational interviewing); and MBS item numbers that facilitate the proposed Model of Care. Canberra: Department of Health and Ageing and Flinders University Models of survivorship care provision in adult patients with haematological cancer: an integrative literature review Nurses attitudes and practices towards provision of survivorship care for people with a haematological cancer on completion of treatment Oncology practitioners' perspectives and practice patterns of post-treatment cancer survivorship care in the Asia-Pacific region: results from the STEP study Mapping unmet supportive care needs, quality-of-life perceptions and current symptoms in cancer survivors across the Asia-Pacific region: results from the International STEP Study Provision of survivorship care for patients with haematological malignancy at completion of treatment: a cancer nursing practice survey study Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium Ensuring treatment fidelity in a multi-site behavioral intervention study: implementing NIH Behavior Change Consortium recommendations in the SMART trial Reliability and validity of the Functional Assessment of Cancer Therapy-Breast qualityof-life instrument A systematic review of quality of life instruments in long-term breast cancer survivors Considerations in determining sample size for pilot studies Sample size of 12 per group rule of thumb for pilot study The Picker Patient Experience Questionnaire: development and validation using data from in-patient surveys in five countries Properties of the Picker Patient Experience questionnaire in a randomized controlled trial of long versus short form survey instruments Evaluation of short dietary questions from the 1995 National Nutrition Survey. keywords: breast; cancer; care; data; follow; health; intervention; model; participants; patient; specialist; study; treatment; trial cache: cord-334956-pi8ifpcy.txt plain text: cord-334956-pi8ifpcy.txt item: #37 of 42 id: cord-336000-v88bq4bx author: Barco, Stefano title: Enoxaparin for primary thromboprophylaxis in ambulatory patients with coronavirus disease-2019 (the OVID study): a structured summary of a study protocol for a randomized controlled trial date: 2020-09-09 words: 20408 flesch: 38 summary: OVID may increase the level of safety compared to standard of care for study patients because frequent telephone visits are planned (Day 3, 7, 14, 30, 90) . Source data must be available at the site to document the existence of the study participants and substantiate the integrity of study data collected. keywords: acute; analysis; anti; bleeding; center; covid-19; covid-19 patients; data; days; dose; enoxaparin; events; hospitalization; information; investigator; medical; outcome; patients; risk; study; study center; test; thromboprophylaxis; treatment; trial; use; vte cache: cord-336000-v88bq4bx.txt plain text: cord-336000-v88bq4bx.txt item: #38 of 42 id: cord-336058-xz26rbav author: Wintner, Lisa M. title: Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial date: 2020-10-13 words: 3743 flesch: 39 summary: PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. The primary trial endpoint is the inter-rater reliability of CTCAE provider ratings for 17 AEs in cancer patients with mixed diagnoses. keywords: cancer; ctcae; data; group; patient; pro; providers; ratings; trial cache: cord-336058-xz26rbav.txt plain text: cord-336058-xz26rbav.txt item: #39 of 42 id: cord-336368-sudi4mdx author: Thiruvenkatarajan, Venkatesan title: High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases (OTHER): study protocol of a randomised multicentric trial date: 2020-05-29 words: 4230 flesch: 41 summary: A prospective assessment of sedation-related adverse events and patient and endoscopist satisfaction in ERCP with anesthesiologist-administered sedation Obesity as a risk factor for sedation-related complications during propofol-mediated sedation for advanced endoscopic procedures A screening instrument for sleep apnea predicts airway maneuvers in patients undergoing advanced endoscopic procedures High-flow nasal interface improves oxygenation in patients undergoing bronchoscopy A nasal high-flow system prevents hypoxia in dental patients under intravenous sedation Clinical evidence on high flow oxygen therapy and active humidification in adults High-flow nasal cannula oxygen therapy in adults High-flow nasal oxygen availability for sedation decreases the use of general anesthesia during endoscopic retrograde cholangiopancreatography and endoscopic ultrasound Optimizing oxygenation and intubation conditions during awake fibre-optic intubation using a high-flow nasal oxygen-delivery system Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations Not applicable. ERCP procedures are unique in terms of their presentation. keywords: ercp; flow; groups; hfnc; nasal; oxygen; patients; procedure; sedation; trial cache: cord-336368-sudi4mdx.txt plain text: cord-336368-sudi4mdx.txt item: #40 of 42 id: cord-344491-93ggxzxu author: Husebo, Bettina Sandgathe title: LIVE@Home.Path—innovating the clinical pathway for home-dwelling people with dementia and their caregivers: study protocol for a mixed-method, stepped-wedge, randomized controlled trial date: 2020-06-09 words: 8729 flesch: 35 summary: Role of caregiver training and risk factors Cost effectiveness of a training program for dementia carers Caregiver burden among dementia patient caregivers: a review of the literature Evidence of what works to support and sustain care at home for people with dementia: a literature review with a systematic approach A randomized controlled trial of a community-based dementia care coordination intervention: effects of MIND at Home on caregiver outcomes A multidimensional home-based care coordination intervention for elders with memory disorders: the Maximizing Independence at Home (MIND) pilot randomized trial Comprehensive home-based care coordination for vulnerable elders with dementia: Maximizing Independence at Home-Plus-Study protocol MIND at Home-Streamlined: study protocol for a randomized trial of home-based care coordination for persons with dementia and their caregivers All interventions are complex, but some are more complex than others: using iCAT_SR to assess complexity Theoretical foundations guiding culture change: the work of the Partnerships in Dementia Care Alliance Assessing the complexity of interventions within systematic reviews: development, content and use of a new tool (iCAT_SR) Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework COSMOS-improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial The effect of a multicomponent intervention on quality of life in residents of nursing homes: a randomized controlled trial (COSMOS) Deprescribing antihypertensive treatment in nursing home patients and the effect on blood pressure Implementing a novel strategy for interprofessional medication review using collegial mentoring and systematic clinical evaluation in nursing homes (COSMOS) Description of an advance care planning intervention in nursing homes: outcomes of the process evaluation Advance care planning in nursing homes-improving the communication among patient, family, and staff: results from a cluster randomized controlled trial (COSMOS) Results of the latter study are highly anticipated due to the potential for effective system-level approaches to dementia care keywords: care; caregivers; coordinators; data; dementia; dyads; health; home; implementation; intervention; month; period; process; pwds; research; study; trial cache: cord-344491-93ggxzxu.txt plain text: cord-344491-93ggxzxu.txt item: #41 of 42 id: cord-349329-f0pbd968 author: Bosteels, Cedric title: Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial date: 2020-06-05 words: 12419 flesch: 40 summary: The study will be conducted cfr the latest version of the ICH E6 (R2) GCP guidelines, creating a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical studies that provides assurance that the data and reported results are accurate and that the rights, integrity and confidentiality of study subjects are protected. Monitoring services will consist of the following (non-exhaustive list): -review of informed consents and the followed process -check on recruitment status -checking for protocol deviations/violations -checking GCP compatibility -check on safety reporting compliance -IMP handling and storage -review of study data … This study can be inspected at any time by regulatory agencies during or after completion of the study. keywords: acute; ards; blood; covid-19; csf; data; day; days; failure; group; intervention; leukine; lung; patients; period; sargramostim; study; subject; treatment cache: cord-349329-f0pbd968.txt plain text: cord-349329-f0pbd968.txt item: #42 of 42 id: cord-350224-dt3li3bk author: Ye, Qingsong title: Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II) date: 2020-06-12 words: 2455 flesch: 41 summary: 2.3 Blood routine: white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils, lymphocytes, monocytes, eosinophils Acidic granulocyte count, basophil count, red blood cell, hemoglobin, hematocrit, average volume of red blood cells, average red blood cell Hb content, average red blood cell Hb concentration, RDW standard deviation, RDW coefficient of variation, platelet count, platelet specific platelet average Volume, platelet distribution width,% of large platelets; 2.4 Liver and kidney function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase, prealbumin, total protein, albumin, globulin, white / globule ratio , Total bilirubin, direct bilirubin, cholinesterase, urea, creatinine, total carbon dioxide, uric acid glucose, potassium, sodium, chlorine, calcium, corrected calcium, magnesium, phosphorus, calcium and phosphorus product, anion gap, penetration Pressure, total cholesterol, triacylglycerol, high density lipoprotein cholesterol, Low density lipoprotein cholesterol, lipoprotein a, creatine kinase, lactate dehydrogenase, estimated glomerular filtration rate. 2.3 Blood routine: white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils, lymphocytes, monocytes, eosinophils Acidic granulocyte count, basophil count, red blood cell, hemoglobin, hematocrit, average volume of red blood cells, average red blood cell Hb content, average red blood cell Hb concentration, RDW standard deviation, RDW coefficient of variation, platelet count, platelet specific platelet average Volume, platelet distribution width,% of large platelets; 2.4 Liver and kidney function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-glutamyl transferase, prealbumin, total protein, albumin, globulin, white / globule ratio , Total bilirubin, direct bilirubin, cholinesterase, urea, creatinine, total carbon dioxide, uric acid glucose, potassium, sodium, chlorine, (Continued on next page) keywords: blood; blood cells; cells; days; patients; period; study cache: cord-350224-dt3li3bk.txt plain text: cord-350224-dt3li3bk.txt