Summary of your 'study carrel' ============================== This is a summary of your Distant Reader 'study carrel'. The Distant Reader harvested & cached your content into a collection/corpus. It then applied sets of natural language processing and text mining against the collection. The results of this process was reduced to a database file -- a 'study carrel'. The study carrel can then be queried, thus bringing light specific characteristics for your collection. These characteristics can help you summarize the collection as well as enumerate things you might want to investigate more closely. This report is a terse narrative report, and when processing is complete you will be linked to a more complete narrative report. Eric Lease Morgan Number of items in the collection; 'How big is my corpus?' ---------------------------------------------------------- 42 Average length of all items measured in words; "More or less, how big is each item?" ------------------------------------------------------------------------------------ 6448 Average readability score of all items (0 = difficult; 100 = easy) ------------------------------------------------------------------ 47 Top 50 statistically significant keywords; "What is my collection about?" ------------------------------------------------------------------------- 22 patient 12 study 8 trial 8 COVID-19 6 day 5 ICU 5 ARDS 4 Health 3 SARS 2 respiratory 2 peep 2 intervention 2 exacerbation 2 RCT 2 LMWH 2 IL-6 1 vestibular 1 ventilation 1 treatment 1 trauma 1 test 1 subject 1 stroke 1 stage 1 school 1 pwd 1 pro 1 plague 1 participant 1 outcome 1 nurse 1 nasal 1 muscle 1 line 1 les 1 ketamine 1 infant 1 indigenous 1 iloprost 1 il6 1 hypertension 1 home 1 health 1 gut 1 grade 1 flow 1 event 1 dna 1 des 1 cure Top 50 lemmatized nouns; "What is discussed?" --------------------------------------------- 2552 patient 2115 study 1427 trial 1045 day 925 treatment 867 datum 714 group 701 intervention 659 analysis 611 % 584 outcome 567 participant 563 protocol 523 time 475 care 444 event 372 effect 349 investigator 349 infection 349 consent 346 case 344 test 338 blood 337 disease 335 sample 329 risk 327 hospital 324 number 318 lung 305 health 304 level 303 information 289 use 289 dose 288 ventilation 285 control 264 year 264 result 252 site 251 visit 251 subject 249 x 249 rate 245 therapy 245 recruitment 242 criterion 241 drug 239 assessment 237 safety 229 randomization Top 50 proper nouns; "What are the names of persons or places?" -------------------------------------------------------------- 326 COVID-19 312 • 297 ICU 213 de 203 ARDS 168 Health 162 SARS 137 RCT 132 University 130 mg 122 Hospital 119 Investigator 113 et 112 la 107 X 104 SAE 102 CoV-2 100 AE 98 du 98 Committee 93 Clinical 89 Research 87 le 87 COPD 87 BSC 82 BALANCE 80 Alexion 79 sargramostim 78 ou 76 Data 75 ravulizumab 74 VTE 71 National 70 kg 69 IL-6 64 enoxaparin 64 Table 64 COVID 63 au 63 Trials 63 Protocol 63 Day 61 Medical 61 Fig 60 SAEs 60 GM 60 Ethics 59 sera 59 China 56 les Top 50 personal pronouns nouns; "To whom are things referred?" ------------------------------------------------------------- 483 we 377 it 211 they 54 them 52 i 28 you 28 he 26 she 14 us 8 themselves 8 itself 5 one 5 me 4 mg 4 him 3 himself 3 herself 2 her 2 aptt 1 peep 1 il-6-sartre Top 50 lemmatized verbs; "What do things do?" --------------------------------------------- 8928 be 1116 have 832 use 623 include 508 follow 369 receive 349 provide 346 base 343 report 266 perform 265 require 259 compare 255 control 246 do 245 treat 225 conduct 223 collect 222 reduce 220 take 217 assess 216 consider 213 associate 200 define 190 participate 187 accord 186 give 180 improve 175 show 174 relate 174 evaluate 165 obtain 158 randomize 157 record 155 increase 152 occur 146 make 146 administer 137 measure 132 develop 129 confirm 125 identify 124 recruit 122 approve 121 complete 117 allow 115 see 114 meet 113 write 112 present 109 enrol Top 50 lemmatized adjectives and adverbs; "How are things described?" --------------------------------------------------------------------- 831 not 709 clinical 696 - 449 respiratory 374 primary 362 other 353 acute 349 also 311 severe 290 medical 273 adverse 271 high 270 non 256 first 225 only 220 additional 215 low 208 more 207 well 205 prior 199 secondary 183 as 176 randomized 176 daily 175 such 165 patient 162 local 157 mechanical 153 positive 152 standard 152 available 150 up 148 informed 143 least 143 however 143 early 142 anti 139 final 137 specific 135 statistical 129 possible 127 inflammatory 126 randomised 125 pulmonary 124 potential 123 current 118 serious 118 covid-19 111 significant 110 appropriate Top 50 lemmatized superlative adjectives; "How are things described to the extreme?" ------------------------------------------------------------------------- 69 least 49 good 34 most 11 bad 9 late 8 high 7 low 6 large 5 close 5 Most 4 common 4 -ch 3 long 2 short 2 near 2 -promptly 2 -Les 1 sick 1 safe 1 great 1 early 1 cord-032926-mrnsaexq 1 cmH2O 1 -D Top 50 lemmatized superlative adverbs; "How do things do to the extreme?" ------------------------------------------------------------------------ 74 least 69 most 2 well 2 lowest 1 hard Top 50 Internet domains; "What Webbed places are alluded to in this corpus?" ---------------------------------------------------------------------------- 19 doi.org 3 www.anzctr.org.au 3 clinicaltrials.gov 2 www.nhc.gov.cn 2 www.irct.ir 2 www.equator-network.org 2 www.chictr.org.cn 2 www 1 www.who 1 www.rilintech.comt 1 www.project-redcap.org 1 www.preprints.org 1 www.medresman.org 1 www.medresman 1 www.ismpp.org 1 www.gnomixx.com 1 www.eortc.org 1 www.clinicaltrialsregister.eu 1 patienterstatningen.dk 1 fundingawards.nihr.ac.uk 1 edc.clinflash.net Top 50 URLs; "What is hyperlinked from this corpus?" ---------------------------------------------------- 19 http://doi.org/10 2 http://www.irct.ir/trial/46946 2 http://www.chictr.org.cn/showproj 2 http://www 1 http://www.who 1 http://www.rilintech.comt 1 http://www.project-redcap.org/ 1 http://www.preprints.org/manuscript/202004.0345/v1 1 http://www.nhc.gov.cn/yzygj/s7653p/2 1 http://www.nhc.gov.cn/ 1 http://www.medresman.org 1 http://www.medresman 1 http://www.ismpp.org/gpp3 1 http://www.gnomixx.com/ 1 http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standardprotocol-items-for-clinical-trials/ 1 http://www.equator-network.org/reporting-guidelines/ 1 http://www.eortc.org/request-for-data/ 1 http://www.clinicaltrialsregister.eu/ctr-search/search?query=ALXN1210-COV-305 1 http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366838&isReview=true 1 http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=36683 1 http://www.anzctr.org.au/Trial/ 1 http://patienterstatningen.dk/ 1 http://fundingawards.nihr.ac.uk/search 1 http://edc.clinflash.net/shbio 1 http://clinicaltrials.gov/ct2/show/NCT04326920?term=sarpac&recrs=ab&draw=2&rank=1 1 http://clinicaltrials.gov/ct2/show/NCT03368092?term= 1 http://clinicaltrials.gov/ Top 50 email addresses; "Who are you gonna call?" ------------------------------------------------- 20 live@home.path 2 ovidstudie@usz.ch 1 slowinski@charite.de 1 moeininm@mums.ac.ir 1 jaglpc@126.com 1 hiruz.ctu@uzgent.be 1 ora@kfshrc.edu.sa Top 50 positive assertions; "What sentences are in the shape of noun-verb-noun?" ------------------------------------------------------------------------------- 24 case report form 11 patient is not 7 patients are not 6 patients do not 5 data are n 5 investigator is responsible 5 patient does not 5 patients showing more 5 study are available 4 days following awareness 4 outcome is time 4 patients are randomly 4 study is not 3 care does not 3 disease requiring initiation 3 intervention is not 3 investigators are not 3 outcome is readmission 3 patient is potentially 3 patient is still 3 patient is unable 3 patients requiring intensive 3 patients show lymphopenia 3 trial is currently 2 analysis is comparison 2 care is not 2 case report forms 2 covid-19 associated ards 2 data are available 2 data are mar 2 disease requiring mechanical 2 event does not 2 event is not 2 events are dyspnea 2 hospital based intervention 2 hospital based trial 2 infection is apparently 2 intervention is successful 2 number is mrc-05 2 numbers are negatively 2 outcome is resource 2 outcomes include length 2 participants are minimal 2 patient is eligible 2 patient is positive 2 patient reported outcome 2 patients are currently 2 patients are severely 2 patients have severe 2 patients have symptoms Top 50 negative assertions; "What sentences are in the shape of noun-verb-no|not-noun?" --------------------------------------------------------------------------------------- 2 patient is not able 2 patient is not eligible 2 patient is not verbally 2 patients are not susceptible 1 care is not standardised 1 data are not part 1 event is not consistent 1 intervention is not merely 1 intervention is not possible 1 intervention is not stigmatising 1 investigators are not financially 1 patient does not retrospectively 1 patient is no longer 1 patient is not yet 1 patients is not adequate 1 study are not publicly 1 study is no less 1 study is not hypothesis 1 time is not sufficient 1 trial is not able 1 trial showed no difference A rudimentary bibliography -------------------------- 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 keywords = patient; trial summary = 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 OBJECTIVES: In this study, we investigate the effect of hydroxychloroquine on the prevention of Novel Coronavirus Disease (COVID-19) in cancer patients being treated. Trial registration: This trial has been registered by the title of "Effect of Hydroxychloroquine on Novel Coronavirus Disease (COVID-19) prevention in cancer patients under treatment" in Iranian Registry of Clinical Trials (IRCT) with code "IRCT20200405046958N1", https://www.irct.ir/trial/46946. Trial registration: This trial has been registered by the title of "Effect of Hydroxychloroquine on Novel Coronavirus Disease (COVID-19) prevention in cancer patients under treatment" in Iranian Registry of Clinical Trials (IRCT) with code "IRCT20200405046958N1", https://www.irct.ir/trial/46946. Also, the help of Clinical Research Development Unit of Akbar Hospital (affiliated to Mashhad University of Medical Sciences, Mashhad, Iran) in designing the study and methodological issues is highly appreciated. The trial has been approved by the Ethical Committee of Mashhad University of Medical Sciences, Iran. doi = 10.1186/s13063-020-04485-x 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 keywords = MERS; day; trial summary = 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 ABSTRACT: The MIRACLE trial (MERS-CoV Infection tReated with A Combination of Lopinavir/ritonavir and intErferon-β1b) investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. Baseline characteristics will be presented for the two study groups (Additional file 1: Table S1 ) including age, sex, and body mass index, the presence of co-infections, nosocomial versus community-acquired MERS infection, Acute Physiology and Chronic Health Evaluation (APA-CHE) II scores, Sequential Organ Failure Assessment scores, and the Karnofsky Performance Status Scale score [3] . The MIRACLE trial investigates the efficacy of a combination therapy of lopinavir/ritonavir and recombinant Interferon-β1b provided with standard supportive care, compared to placebo provided with standard supportive care, in hospitalized patients with laboratory-confirmed MERS. doi = 10.1186/s13063-019-3846-x 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 keywords = COVID-19; LMWH; SARS; VTE; day; line; patient; study summary = OBJECTIVES: The OVID study will demonstrate whether prophylactic-dose enoxaparin improves survival and reduces hospitalizations in symptomatic ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation. The OVID study will show whether prophylactic-dose enoxaparin improves survival and reduces any hospitalizations in ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation. <30% of the expected number of patients six months after the enrolment of the first patient, also based on the course of SARS-CoV2 infections in Switzerland;  when the safety of the participants is doubtful or at risk, respectively, based on recommendations received from DSMB committee;  changes in accepted clinical practice that make the continuation of a clinical trial unwise, including the results of similar studies or the publication of international guidances. doi = 10.1186/s13063-020-04678-4 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 keywords = ICU; KFSH&RC; ketamine; patient summary = 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 The 2018 Pain, Agitation/sedation, Delirium, Immobility, and Sleep disruption guideline suggested low-dose ketamine infusion as an adjunct to opioid therapy to reduce opioid requirements in post-surgical patients in the intensive care unit (ICU). Therefore, we propose a prospective, randomized, active controlled, open-label, pilot, feasibility study to assess the effect and safety of Analgo-sedative ad-juncT keTAmine Infusion iN Mechanically vENTilated ICU patients (the ATTAINMENT trial) compared to standard of care alone. Physician decline after randomization Ketamine will be discontinued Subject will be included in the data analysis a In cases of death (either within the first 48 h, until ICU or hospital discharge, or 28 days after randomization, whichever comes first), detailed documentation will be carried out in the medical record for the cause of death, group allocation, and relation to study protocol allocation and initiation of the trial intervention. doi = 10.1186/s13063-020-4216-4 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 keywords = ARDS; COVID-19; CSF; Leukine; day; patient summary = -Presence of acute hypoxic respiratory failure defined as (either or both)  saturation below 93% on minimal 2 l/min O2  PaO2/FiO2 below 350 -Admitted to specialized COVID-19 ward -Age 18-80 -Male or Female -Willing to provide informed consent Exclusion criteria -Patients with known history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony stimulating factor such as sargramostim, yeast-derived products, or any component of the product. Study Interventions Confirmed or highly suspect COVID-19 patients with acute hypoxic respiratory failure (saturation below 93% on minimal 2 l/min O2 or PaO2/FiO2 <350) will be randomized to receive sargramostim 125mcg twice daily for 5 days as a nebulized inhalation on top of standard of care (active group), or to receive standard of care treatment (control group). doi = 10.1186/s13063-020-04451-7 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 keywords = COVID-19; IL-6; SOC; il6; patient; study summary = The aim of the present study is to evaluate if an earlier therapeutic intervention with sarilumab plus SOC (including corticosteroids) may be more effective than current standard of care alone, in preventing progression to respiratory failure in COVID-19 infected patients with interstitial pneumonia. The aim of the present study is to evaluate if an earlier therapeutic intervention with sarilumab plus SOC may be more effective than current standard of care alone, which according to our local protocol includes weight adjusted corticosteroids doses, in preventing progression to respiratory failure in COVID-19 infected patients with interstitial pneumonia. Patients randomized to the control arm (CS + SOC group without sarilumab) progressing to severe respiratory failure fulfilling criteria for treatment with anti-IL6 inhibitors according to clinical practice guidelines, as defined by the presence of Brescia-COVID SARTRE STUDY EudraCT Number: 2020-002037-15 Version 2.0 (May 05th 2020) Scale 2-3 plus inflammatory markers, will be offered the option to be rescued with sarilumab at the same doses and be included in an open-label follow-up phase. doi = 10.1186/s13063-020-04633-3 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 keywords = Australia; Cancer; Health; care; nurse summary = 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) This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up. The objective of the study is to test the feasibility of a prospective, pragmatic randomised controlled trial (RCT) of the EMINENT intervention-a nurse-enabled, integrated, shared-care model involving cancer specialists and GPs for early breast cancer post-treatment follow-up. Training includes provision of study manual containing • Generic study information: standard operating procedures, study overview, reporting and documentation guidelines, communication flowchart, rationale for the study treatment, completion of survivorship care plan, self-management goal setting, and health coaching • Specialist Cancer Nurse-specific information: job description, intervention protocol, quality assurance, and monitoring An 8-h training program will be delivered by Experts in Cancer Survivorship and motivational interviewing. doi = 10.1186/s13063-020-04740-1 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 keywords = australian; indigenous; infant; respiratory summary = Our randomised, placebo-controlled trial of azithromycin in Indigenous infants hospitalised with bronchiolitis is designed to determine whether it can reduce short-term (and potentially long-term) morbidity from respiratory illness in Australian Indigenous infants who are at high risk of developing chronic respiratory illness. Indigenous infants (aged ≤ 24-months, expected number = 200) admitted to one of two regional hospitals (Darwin, Northern Territory and Townsville, Queensland) with a clinical diagnosis of bronchiolitis and fulfilling inclusion criteria are randomised (allocation concealed) to either azithromycin (30 mg/kg/dose) or placebo administered once weekly for three doses. Indigenous infants (aged ≤ 24-months, expected number = 200) admitted to one of two regional hospitals (Darwin, Northern Territory and Townsville, Queensland) with a clinical diagnosis of bronchiolitis and fulfilling inclusion criteria are randomised (allocation concealed) to either azithromycin (30 mg/kg/dose) or placebo administered once weekly for three doses. doi = 10.1186/1745-6215-12-94 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 keywords = bronchiectasis; child; exacerbation; respiratory; study summary = Our study tests the hypothesis that both oral azithromycin and amoxicillin-clavulanic acid are superior to placebo at improving resolution rates of respiratory exacerbations by day 14 in children with bronchiectasis unrelated to cystic fibrosis. Our multicentre, double-blind RCT is designed to determine if azithromycin and amoxicillin-clavulanic acid, compared with placebo, improve symptom resolution on day 14 in children with acute respiratory exacerbations. Early and effective management of bronchiectasis exacerbations in children may lead to reduced hospitalisations, better quality of life (QOL) and improved future adult lung function. Our study tests the primary hypothesis that both oral azithromycin and amoxicillin-clavulanic acid are superior to placebo in improving the resolution rate of respiratory exacerbations by day 14 in children with non-CF bronchiectasis. We are conducting a multicentre, parallel group, double-blind placebo RCT (with concealed allocation) to assess the impact of treatment with antibiotics (azithromycin or amoxicillinclavulanic acid) in children with an exacerbation of bronchiectasis. doi = 10.1186/1745-6215-13-156 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 keywords = BALANCE; ICU; RCT summary = The Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE) pilot randomized clinical trial (RCT) determined that it was feasible to enroll and randomize intensive care unit (ICU) patients with bloodstream infection to 7 versus 14 days of treatment, and served as the vanguard for the ongoing BALANCE main RCT. METHODS: We conducted an open pilot RCT among a subset of six sites participating in the ongoing BALANCE RCT, randomizing patients with positive non-Staphylococcus aureus blood cultures on non-ICU wards to 7 versus 14 days of antibiotic treatment. Conclusion: It is feasible to enroll non-ICU patients in a trial of 7 versus 14 days of antibiotics for bloodstream infection, and expanding the BALANCE RCT hospital-wide has the potential to improve the timeliness and generalizability of trial results. Conclusion: It is feasible to enroll non-ICU patients in a trial of 7 versus 14 days of antibiotics for bloodstream infection, and expanding the BALANCE RCT hospital-wide has the potential to improve the timeliness and generalizability of trial results. doi = 10.1186/s13063-019-4033-9 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 keywords = COVID-19; SARS; des; les summary = 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. L''objectif de cet essai randomisé contrôlé, bicentrique, est d''évaluer 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. 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. doi = 10.1186/s13063-020-04585-8 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 keywords = aspirin; covid-19; patient; study summary = 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 Patients with a critical illness (WHO clinical improvement ordinal score > 5), documented significant liver disease/dysfunction (aspartate transaminase [AST] / alanine aminotransferase [ALT] > 240), myopathy and rhabdomyolysis (creatine phosphokinase [CPK] > 5x normal), allergy or intolerance to statins or aspirin, prior statin or aspirin use within 30 days, history of active gastrointestinal bleeding in past three months, coagulopathy, thrombocytopenia (platelet count < 100000/ dl), pregnancy, active breastfeeding, or inability to take oral or nasogastric medications will be excluded. INTERVENTION AND COMPARATOR: In this study, the benefit and safety of atorvastatin (statin) and/or aspirin as adjuvant therapy will be compared with the control group receiving usual care for management of COVID-19. doi = 10.1186/s13063-020-04840-y 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 keywords = COVID-19; Hospital; SARS; study summary = OBJECTIVES: The aim of this study is to assess the efficacy of the use of pre-exposure prophylaxis (PrEP) with hydroxychloroquine against placebo in healthcare workers with high risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in reducing their risk of coronavirus disease 2019 (COVID-19) disease during an epidemic period. As secondary endpoints, we will obtain: i) the SARS-CoV-2 seroconversion in the PrEP group compared to placebo during the 6 months of follow-up in healthcare workers with negative serology at day 0; ii) the occurrence of any adverse event related with hydroxychloroquine treatment; iii) the incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers in the non-PrEP group, among the total of healthcare workers included in the non-PrEP group during the study period; iv) the risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19; v) a repository of serum samples obtained from healthcare workers confirmed COVID-19 cases for future research on blood markers to predict SARS-CoV-2 infection. doi = 10.1186/s13063-020-04621-7 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 keywords = ARDS; ICU; iloprost; patient summary = Several preclinical studies have revealed a beneficial effect of iloprost on the control of pulmonary inflammation, and in a small number of patients with ARDS, iloprost treatment resulted in improved oxygenation. For safety reasons, after treatment of 100 patients (day 28 after last dose investigational medicinal product [IMP] Patient 100) within the study, an interim analysis for an increased risk for pulmonary hemorrhage ≥ grade III according to Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) Version 5.0 in the treatment (iloprost) arm will be performed and the results discussed with the Data and Safety Monitoring Board (DSMB). 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 X X X X X X X X Health-related questionnaire X VES X performed. doi = 10.1186/s13063-020-4163-0 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 keywords = ISSNHL; patient; test; vestibular summary = title: Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial The primary outcomes will be vestibular function outcomes assessed by sensory organization test, caloric test, video head impulse test, cervical vestibular evoked myogenic potential, and ocular vestibular evoked myogenic potential; the secondary outcomes include self-reported vestibular dysfunction symptoms; dizziness-related handicap, visual analogue scale for vertigo and tinnitus; and pure tone audiometry. 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] . doi = 10.1186/s13063-020-04579-6 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 keywords = Health; Norway; home; intervention; pwd; trial summary = In the COSMOS trial, a randomized implementation hybrid trial carried out in Norwegian nursing homes during 2014-2015, our group successfully developed, implemented and effect evaluated a multicomponent intervention addressing COmmunication, Systematic assessment and treatment of pain, Medication review, Organization of activities and Safety [22] . In practice in the LIVE@Home.Path: the coordinator will encourage and facilitate that both the PWD and the caregiver participate in local educational programs arranged by the municipality or the specialist health services several times yearly. PWDs are eligible for inclusion if they: are aged ≥ 65 years; are home-dwelling; have a minimum 1 h/week regular face-to-face contact with the caregiver; are diagnosed with dementia according to standardized protocol [60] ; have Mini-Mental State Examination (MMSE) score of 15-25; have a Functional Assessment Staging Test (FAST) score of 4-7; and provide written informed consent. A randomized controlled trial of a community-based dementia care coordination intervention: effects of MIND at Home on caregiver outcomes doi = 10.1186/s13063-020-04414-y 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 keywords = Acacia; arabic summary = 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 OBJECTIVES: To investigate the potential efficacy of Acacia Senegal extract Gum Arabic (GA) supplementation as immunomodulatory and anti-inflammatory dietary intervention among newly diagnosed COVID 19 Sudanese patients. Age 8-90 years Both genders Exclusion criteria: Intubated patients on parenteral treatment Allergy to Gum Arabic The study will be conducted in COVID Isolation Centres and Soba University Hospital Khartoum State Sudan. Mortality rate: The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo (Four weeks from the start of randomization]). Gum Arabic has anti-inflammatory effect which has been investigated in various diseases and conditions. Gum Arabic anti-inflammatory effect has been investigated in clinical trials (10, 12) . Gum Arabic Fibers Decreased Inflammatory Markers and Disease Severity Score among Rheumatoid Arthritis Patients, Phase II Trial doi = 10.1186/s13063-020-04707-2 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 keywords = patient; trial summary = 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 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. RANDOMISATION: After inclusion, the patients will be randomized using a closed envelope method into the conventional treatment group, which uses the standard strategy and the experimental group which receives anticoagulation treatment with bivalirudin using an allocation ratio of 1:1. TRIAL REGISTRATION: The protocol is registered before starting subject recruitment under the title: "Anticoagulation in patients suffering from COVID-19 disease. To prove the positive effect of anticoagulation with bivalirudin intravenously on gas-exchange in patients with COVID-19 and respiratory failure on invasive mechanical ventilation. Inclusion criteria: all adult patients admitted to the ICU who are COVID positive tested and in need for mechanical ventilation are eligible for inclusion. doi = 10.1186/s13063-020-04689-1 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 keywords = ARDS; RCT; cure; patient; peep summary = BACKGROUND: 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. The Clinical utilisation of respiratory elastance (CURE) trial is a two-arm, randomised controlled trial (RCT) investigating the performance of PEEP selected at an objective, model-based minimal respiratory system elastance in patients with ARDS. Secondary outcomes include length of time of MV, ventilator-free days (VFD) up to 28 days, ICU and hospital length of stay, AUC of oxygen saturation (SpO(2))/FiO(2) during MV, number of desaturation events (SpO(2) < 88%), changes in respiratory mechanics and chest x-ray index scores, rescue therapies (prone positioning, nitric oxide use, extracorporeal membrane oxygenation) and hospital and 90-day mortality. Following the study, a phase-2 randomised controlled trial (RCT) was designed to assess mechanical ventilation at minimal elastance PEEP in patients with ARDS versus standard practice of care in a single-centre hospital. doi = 10.1186/s13063-019-4035-7 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 keywords = COPD; China; TCM; day; exacerbation; trial summary = 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 The present study aims to evaluate the efficacy and safety of Jia Wei Bushen Yiqi (JWBY) formulas in patients who suffer from COPD exacerbations and to investigate whether the short-term (5-days) systemic glucocorticoid therapy is non-inferior to the long-term (9-day) regime. On one hand, a dose of 40 mg prednisone (a common oral systemic glucocorticoid) daily for 5 days has been recommended by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Science Committee Report based on the REDUCE randomized clinical trial since 2015 [24] . We conducted a randomized and placebo-controlled trial enrolling stable COPD patients in 2014, which illustrated that TCM formulas called Bushen Yiqi (BY) formulas can improve the lung function, reduce the frequency of acute exacerbation of COPD, and modulate the HPA axis [35] . doi = 10.1186/s13063-020-04669-5 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 keywords = Anakinra; COVID-19; IL-1; IL-6; patient; study; subject summary = -mechanical ventilation > 24 h at randomization -clinical frailty scale above 3 -active bacterial or fungal infection -unlikely to survive beyond 48h -neutrophil count below 1500 cells/microliter -platelets below 50.000/microliter -Patients enrolled in another investigational drug study -patients on high dose systemic steroids (> 8 mg methylprednisolone or equivalent for more than 1 month) for COVID-19 unrelated disorder -patients on immunosuppressant or immunomodulatory drugs -patients on current anti-IL1 or anti-IL6 treatment -signs of active tuberculosis -serum transaminase levels >5 times upper limit of normal, unless there are clear signs of cytokine release syndrome defined by LDH >300 IU/L and ferritin >700 ng/ml -history of (non-iatrogenic) bowel perforation or diverticulitis -Pregnant or breastfeeding females (all female subjects deemed of childbearing potential by the investigator must have negative pregnancy test at screening) 5.2.1. doi = 10.1186/s13063-020-04453-5 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 keywords = Aedes; DENV; Health; TIRS; Yucatan; abv summary = METHODS/DESIGN: We are pursuing a two-arm, parallel, unblinded, cluster randomized controlled trial to quantify the overall efficacy of TIRS in reducing the burden of laboratory-confirmed ABV clinical disease (primary endpoint). Fitting such entomological information to an agent-based model of Yucatan State, Mexico, showed that high levels of TIRS coverage (75% of houses treated once per year) applied preemptively before the typical dengue season (before July) could reduce DENV infections by 89.7% in year 1 and 78.2% cumulatively over the first 5 years of an annual program [32] . Additionally, our project will access the online ABV database managed by Mexico''s National Center of Preventive Programs and Diseases Control (CENAPRECE) [51] to identify all reported symptomatic cases (including all ages, not only children) residing within study clusters in real time, and to map routine vector control actions performed by SSY. doi = 10.1186/s13063-020-04780-7 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 keywords = IMV; LMWH; event summary = 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 This dose is commonly used in Italy when a bridging strategy is required for the management of surgery or invasive procedures in patients taking anti-vitamin K oral anticoagulants The treatment with Enoxaparin will be initiated soon after randomization (maximum allowed starting time 12h after randomization). Assuming an alpha of 5% (two tailed) and a percentage of patients who experience clinical worsening in the control group being between 25% and 30%, the study will have 80% power to detect at least 50% relative reduction in the risk of death between low and high doses of heparin. Lack or withdrawal of informed consent Intervention and comparator: Control Group (Low-Dose LMWH): patients in this group will be administered Enoxaparin (Inhixa®) at standard prophylactic dose (i.e., 4000 UI subcutaneously once day). doi = 10.1186/s13063-020-04475-z 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 keywords = Health; hypertension; study summary = This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03504124. Specifically, these strategies include team-based care, health coaching sessions, home-based blood pressure (BP) monitoring, clinical decision support, BP audit and feedback, and training of healthcare providers. This study is an implementation-effectiveness, hybrid, type 2, cluster randomized control trial that will evaluate a multilevel and multicomponent hypertension control program within the Guatemalan primary care system [17] . The multicomponent program includes a protocol-based hypertension treatment and five implementation strategies: team-based collaborative care, health provider education, health coaching sessions, home blood pressure monitoring, and blood pressure audit and feedback. The overarching aim of this study is to evaluate the clinical effectiveness and implementation outcomes of a hypertension control multicomponent program within the first and second levels of care in Guatemala, compared to usual care. doi = 10.1186/s13063-020-04345-8 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 keywords = ARDS; ICU; dna; patient; study; trauma summary = 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 Dornase alfa is a US Food and Drug Administration-approved recombinant DNase, which cleaves extracellular DNA and may therefore break up the backbone of NETs and DAMPs. Aerosolized dornase alfa was shown to reduce trauma-induced lung injury in experimental models and to improve arterial oxygenation in ventilated patients. 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. The primary objective of the TRAUMADORNASE study is to demonstrate a reduction in the incidence of moderateto-severe hypoxaemia from 45% to 30% in severe trauma patients during the first 7 ICU days by providing aerosolized dornase alfa once during the first 2 ICU days as compared to equivalent provision of placebo (NaCl 0.9%). doi = 10.1186/s13063-020-4141-6 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 keywords = Madagascar; ciprofloxacin; patient; plague; trial summary = All drugs in use for treating plague are registered based on experimental data and anecdotal evidence, and no regimen currently recommended is supported by a randomized clinical trial. The primary endpoint of the trial is to assess the proportion of patients with bubonic plague who have a therapeutic response to treatment (defined as alive, resolution of fever, 25% reduction in the size of measurable buboes, has not received an alternative treatment and no clinical decision to continue antibiotics) as assessed on day 11. The secondary objective is to collect data on the effectiveness of ciprofloxacin in the treatment of pneumonic plague, although the trial is not able to formally assess the non-inferiority of ciprofloxacin monotherapy compared to streptomycin and ciprofloxacin combination therapy in pneumonic plague, Considering the operational and practical complexities of a plague RCT, the study also has additional exploratory objectives to optimize investments: to evaluate the level and kinetics of anti-Y. doi = 10.1186/s13063-020-04642-2 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 keywords = NAIROS; nasal; outcome; participant; patient; trial summary = Secondly, consent to have the discussion about the NAIROS trial with the investigator audio-recorded and their details passed onto • Any prior septal surgery • Systemic inflammatory disease or the use of any current oral steroid treatment within the past 2 weeks • Granulomatosis with polyangiitis • Nasendoscopic evidence of unrelated associated pathology, e.g. adenoid pad, septal perforation, chronic rhinosinusitis indicated by the presence of polyposis or pus • Any history of intranasal recreational drug use within the past 6 months • Breast-feeding, pregnancy or intended pregnancy for the duration of involvement in the trial • Bleeding diathesis • Therapeutic anticoagulation (warfarin/novel oral anti-coagulant (NOAC) therapy) • Clinically significant contraindication to general anaesthesia • Patients known to be immuno-compromised • Those in whom an external bony deformity substantially contributes to the nasal obstruction a member of the qualitative team for a telephone interview. doi = 10.1186/s13063-020-4081-1 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 keywords = ARDS; patient; ventilation summary = 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 OBJECTIVES: This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (ARDS) associated with COVID-19.We define ARDS according to the "Berlin" definition integrating the oxygenation index (P/F ratio), the level of Positive End Expiratory Pressure (PEEP), radiological and clinical findings. TRIAL REGISTRATION: The protocol was registered before starting subject recruitment under the title: "Flow controlled ventilation in ARDS associated with COVID-19" in ClinicalTrials.org with the registration number: NCT04399317. Although the severely ill patients will need intubation and invasive ventilation according to ARDS treatment strategies including low tidal volumes and low end-expiratory pressures, not all patients recover their pulmonary function [3, 4] . doi = 10.1186/s13063-020-04708-1 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 keywords = ICU; gut; muscle; patient summary = METHODS: This is a prospective, single-center, double-blind, parallel randomized controlled trial with the aim to evaluate the effects of synbiotic supplementation on energy and macronutrient homeostasis and muscle wasting in critically ill patients. DISCUSSION: Gut microbiota modulation through synbiotics is proposed to improve clinical prognosis and reduce infectious complications, ventilator dependency, and length of ICU stay by improving energy and macronutrient homeostasis and reducing muscle protein catabolism. Previous studies suggest that modulating gut microbiota by novel therapeutics, such as prebiotics, probiotics, or synbiotics, can have an effect on gastrointestinal tolerance and complications of enteral nutrition, which eventually lead to the regulation of energy intake. Considering the extreme dysbiosis in critically ill patients and related energy and macronutrients homeostasis disturbance and muscle wasting, prompted us to evaluate the effect of synbiotic supplementation on the elimination of this condition. The primary objective is to evaluate the effects of synbiotic supplementation on energy and macronutrient homeostasis and muscle wasting in patients under critical care. doi = 10.1186/s13063-020-4136-3 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 keywords = COVID; analysis; patient summary = The ProPac-COVID trial evaluates whether combination therapy with macrolide azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy, and pre-emptive treatment of supra-infections can shorten hospitalization duration and reduce the risk of non-invasive ventilation, treatment in the intensive care unit, and death in patients with acute hospital admission and a positive test for 2019-nCoV and symptoms of COVID-19 disease. The objective of this randomized, placebo-controlled, double-blinded multi-center trial is to investigate whether 15-day treatment with azithromycin and hydroxychloroquine added to standard of care can shorten hospitalization and reduce the risk of non-invasive ventilation, admittance to ICU, and death. The interim analysis will focus on reporting the following: selected baseline data (those readily available from the baseline data list below), primary outcome (in an O'' Brien-Fleming Plot), and all-cause mortality at 30 days (chi-square or Fisher''s exact test, whichever appropriate). doi = 10.1186/s13063-020-04795-0 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 keywords = Azithromycin; COVID-19; patient; study; treatment; trial summary = OBJECTIVES: The aim of this randomised GCP-controlled trial is to clarify whether combination therapy with the antibiotic azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy and pre-emptive treatment of supra-infections can shorten hospitalisation duration for patients with COVID-19 (measured as "days alive and out of hospital" as the primary outcome), reduce the risk of noninvasive ventilation, treatment in the intensive care unit and death. Fertile women* must not be pregnant, i.e. negative pregnancy test must be available at inclusion • Informed consent signed by the patient *Defined as after menarche and until postmenopausal (no menstruation for 12 months) Exclusion criteria: • At the time of recruitment, the patient uses >5 LO2/min (equivalent to 40% FiO2 if measured) • Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinoline derivatives • Neurogenic hearing loss • Psoriasis • Retinopathy • Maculopathy • Visual field changes • Breastfeeding • Severe liver diseases other than amoebiasis (INR> 1.5 spontaneously) • Severe gastrointestinal, neurological and hematological disorders (investigator-assessed) • eGFR <45 ml/min/1.73 m2 • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms). doi = 10.1186/s13063-020-04409-9 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 keywords = ALXN1210-COV-305; Alexion; Amendment; BSC; Investigator; SAE; day; patient; study summary = Study ALXN1210-COV-305 is a multicenter Phase 3, open-label, randomized, controlled study designed to evaluate the safety and efficacy of intravenous (IV) ravulizumab + best supportive care (BSC), compared with BSC alone in patients with a confirmed diagnosis of SARS-CoV-2 infection, and a clinical presentation consistent with COVID-19 severe pneumonia, acute lung injury, or ARDS. doi = 10.1186/s13063-020-04548-z 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 keywords = patient; study summary = 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 TRIAL DESIGN: Phase IIb, multicenter, prospective, open-label, randomized, 1:1 parallel group pilot study comparing the additional use of "CytoSorb" to standard of care without "CytoSorb". Intervention and comparator: Within 24 hours after meeting the inclusion criteria patients will be randomized to receive either standard of care or standard of care and additional "CytoSorb" therapy via a shaldon catheter for 3-7 days. Keywords: COVID-19, Randomized controlled trial, protocol, cytokine storm, vasoplegic shock, extracorporeal cytokine elimination Authors'' contributions TS, PE and HS designed the trial, wrote the study protocol, obtained ethical approval and applied for BMBF funding. TK did the biostatistic design of the trial and wrote the statistical section of the study protocol, ethical approval and BMBF application. Furthermore, the study protocol, the statistical analysis plan, the patient information and the patient consent form will be made available to all interested persons. doi = 10.1186/s13063-020-04501-0 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 keywords = Southampton; health; intervention; school summary = The EACH-B intervention consists of three linked elements: professional development for teachers including training in communication skills to support health behaviour change; the LifeLab educational module comprising in-school teaching of nine science lessons linked to the English National Curriculum and a practical day visit to the LifeLab facility; and a personalised digital intervention that involves social support and game features that promote eating better and being more active. i) Professional development for teachers including training in communication skills to support health behaviour change, known as ''Healthy Conversation Skills'' (HCS), explained in detail below ii) LifeLab educational module comprising in-school teaching of nine science lessons linked to the English National Curriculum and a hands-on practical day visit to LifeLab, held part way through the module iii) A personalised digital intervention (the ''app'') with social support and game features doi = 10.1186/s13063-020-04761-w 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 keywords = ERCP; HFNC; flow; patient summary = 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 METHODS/DESIGN: This is a prospective, randomised, multicentre trial comparing the efficacy of oxygen supplementation through HFNC versus low-flow nasal cannula during ERCP, in a cohort of patients at risk of adverse respiratory events. The secondary outcomes include parameters centred on oxygenation, requirement of airway manoeuvres, successful completion of procedure, perioperative complications, patient satisfaction and cost analysis of the consumables. The aim of the OTHER (Oxygen Therapy in High risk ERCP) trial is to assess the efficacy and safety of oxygen supplementation achieved through HFNC compared with low-flow nasal cannula during ERCP in a cohort of patients at risk of adverse respiratory events. Our study is the first multicentre randomised controlled trial comparing low-flow versus high-flow nasal oxygen therapy for improving oxygenation in high-risk patients for ERCP. doi = 10.1186/s13063-020-04378-z 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 keywords = CPAP; peep; study summary = BACKGROUND: Nasal continuous positive airway pressure (CPAP) applies positive end-expiratory pressure (PEEP) and has been shown to reduce the need for intubation and invasive mechanical ventilation in very low birth weight infants with respiratory distress syndrome. Results of a secondary analysis from a cohort study in 34 international centers that participated in a nasal intermittent positive pressure ventilation trial indicate a large variation of PEEP levels used in clinical practice during neonatal resuscitation and the first 28 days of life (i.e., 3-9 cmH 2 O) [10] . The primary hypothesis of this study is that the use of a higher PEEP range in preterm infants born at 26 + 0-29 + 6 weeks gestational age (GA) receiving prophylactic nasal CPAP support after birth reduces the incidence of intubation and/or meeting predefined CPAP failure criteria within the first 120 h of life when compared to the application of a lower PEEP range. doi = 10.1186/s13063-020-04660-0 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 keywords = COVID-19; stage summary = 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 TRIAL DESIGN: ACCORD is a seamless, Phase 2, adaptive, randomised controlled platform study, designed to rapidly test candidate agents in the treatment of COVID-19. If Stage 1 provides evidence of efficacy and acceptable safety the candidate will enter Stage 2 where a total of approximately 126 patients will be recruited into each study arm sub-protocol. PARTICIPANTS: The study will include hospitalised adult patients (≥18 years) with confirmed SARS-CoV-2 infection, the virus that causes COVID-19, that clinically meet Grades 3 (hospitalised – mild disease, no oxygen therapy), Grades 4 (hospitalised, oxygen by mask or nasal prongs) and 5 (hospitalised, non-invasive ventilation or high flow oxygen) of the WHO Working Group on the Clinical Characteristics of COVID-19 9-point category ordinal scale. doi = 10.1186/s13063-020-04584-9 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 keywords = CTCAE; EORTC; pro summary = 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 Patients aged 18 or above Any cancer diagnosis (no more than 20% per diagnostic group) Current treatment with chemotherapy or immunotherapy Inpatient or day clinic setting Scoring 3 or above on an initial screening question ("On a scale from 0 to 10, to what degree did you experience physical or emotional symptoms/ problems during the last week?") No psychiatric or mental problems (i.e., no such diagnosis in the medical records) Written informed consent Participating providers are requested to be either a medical, surgical, or radiation oncologist by training or a specially trained nurse authorized to perform CTCAE assessments in clinical trials, both with at least 1-year experience in oncology. doi = 10.1186/s13063-020-04745-w 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 keywords = AQI; Beijing; asthma summary = title: The rescue intervention strategy for asthma patients under severe air pollution: a protocol for a single-centre prospective randomized controlled trial Therefore, we hypothesize that the rescue intervention strategy of budesonide/formoterol plus original treatments under severe pollution may reduce the risk of asthma exacerbations caused by air pollution before patients have symptoms. When the air quality index (AQI) reported by the air pollution monitoring station for the study is no less than 200, participants in the RIS group will receive budesonide/formoterol (160 μg/4.5 μg/dose, 1 dose/time, b.i.d.) plus original treatments until the end of severe pollution (AQI < 200). This singlecentre, prospective, randomized and standard treatment parallel control clinical trial aimed to determine whether the rescue intervention strategy will reduce the risk of air pollution-related asthma exacerbations. This is a single-centre, prospective, randomized and standard treatment parallel control study aimed at decreasing the risk of asthma exacerbations under severe air pollution with a novel rescue intervention strategy. doi = 10.1186/s13063-020-04830-0 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 keywords = blood; cell; grade summary = 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) The experimental group will receive an intravenous injection of dental pulp stem cells suspension (3.0x10(7) human DPSCs in 30ml saline solution) on day 1, 4 and 7; The control group will receive an equal amount of saline (placebo) on the same days. The experimental group will receive an intravenous injection of dental pulp stem cells suspension (3.0x10 7 human DPSCs in 30ml saline solution) on day 1, 4 and 7; Full study protocol.Authors'' contributions QY, ZW and SLW conceived the research idea; QY, HW, XX, YH and GZ designed the study protocol and developed the research plan; CZ and QY obtained the ethics approval; QY and ZL coordinated the tasks among different investigators; CZ, ZZ, ZL and QY YZ and KH recruited the participants and collected data. doi = 10.1186/s13063-020-04380-5 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 keywords = day; patient; stroke summary = 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 AIMS AND DESIGN: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke (PRECIOUS) is an international, multi-centre, 3 × 2 factorial, randomised, controlled, open-label clinical trial with blinded outcome assessment, which will assess whether prevention of aspiration, infections, or fever with metoclopramide, ceftriaxone, paracetamol, respectively, or any combination of these in the first 4 days after stroke onset improves functional outcome at 90 days in elderly patients with acute stroke. The primary objective is to assess whether prevention of aspiration, infections, or fever with metoclopramide, ceftriaxone, paracetamol, or any combination of these in the first 4 days after stroke onset improves functional outcome at 90 days in older patients with acute stroke. doi = 10.1186/s13063-020-04717-0