Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy – the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial

[1]  Meilan K. Han,et al.  Lung Microbiota Contribute to Pulmonary Inflammation and Disease Progression in Pulmonary Fibrosis , 2019, American journal of respiratory and critical care medicine.

[2]  J. Smith,et al.  Randomised, double-blind, placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis , 2019, Thorax.

[3]  M. Pletcher,et al.  Exploring Meaningful Patient Engagement in ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness) , 2018, Medical care.

[4]  J. Ioannidis,et al.  Assessment of Pragmatism in Recently Published Randomized Clinical Trials , 2018, JAMA internal medicine.

[5]  Takeshi Johkoh,et al.  Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline , 2018, American journal of respiratory and critical care medicine.

[6]  D. Lederer,et al.  Idiopathic Pulmonary Fibrosis. , 2018, The New England journal of medicine.

[7]  J. Ioannidis,et al.  Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic? , 2018, BMC Medicine.

[8]  D. Thickett,et al.  The Efficacy and Mechanism Evaluation of Treating Idiopathic Pulmonary fibrosis with the Addition of Co-trimoxazole (EME-TIPAC): study protocol for a randomised controlled trial , 2018, Trials.

[9]  Kenneth A Getz,et al.  New Benchmarks Characterizing Growth in Protocol Design Complexity , 2018, Therapeutic innovation & regulatory science.

[10]  D. Lynch,et al.  Usual Interstitial Pneumonia Can Be Detected in Transbronchial Biopsies Using Machine Learning , 2017, Annals of the American Thoracic Society.

[11]  H. Collard,et al.  Pirfenidone Reduces Respiratory‐related Hospitalizations in Idiopathic Pulmonary Fibrosis , 2017, American journal of respiratory and critical care medicine.

[12]  Yaning Wang,et al.  Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis , 2017, Annals of the American Thoracic Society.

[13]  H. Collard,et al.  Design of the PF-ILD trial: a double-blind, randomised, placebo-controlled phase III trial of nintedanib in patients with progressive fibrosing interstitial lung disease , 2017, BMJ Open Respiratory Research.

[14]  Yves A. Lussier,et al.  Microbes Are Associated with Host Innate Immune Response in Idiopathic Pulmonary Fibrosis , 2017, American journal of respiratory and critical care medicine.

[15]  Athol U. Wells,et al.  Host‐Microbial Interactions in Idiopathic Pulmonary Fibrosis , 2017, American journal of respiratory and critical care medicine.

[16]  P L Molyneaux,et al.  Integrierte Analyse von Patienten-Genen und respiratorischem Mikrobiom , 2017, Pneumologie.

[17]  Keiichi Yamamoto,et al.  A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM , 2017, J. Biomed. Informatics.

[18]  K. Getz,et al.  Trial watch: Trends in clinical trial design complexity , 2017, Nature Reviews Drug Discovery.

[19]  M. Moffatt,et al.  Changes in the respiratory microbiome during acute exacerbations of idiopathic pulmonary fibrosis , 2017, Respiratory Research.

[20]  S. Nathan,et al.  Effect of pirfenidone on mortality: pooled analyses and meta-analyses of clinical trials in idiopathic pulmonary fibrosis. , 2017, The Lancet. Respiratory medicine.

[21]  E. Antman,et al.  The Changing Landscape of Randomized Clinical Trials in Cardiovascular Disease. , 2016, Journal of the American College of Cardiology.

[22]  F. Martinez,et al.  The Microbiome and the Respiratory Tract. , 2016, Annual review of physiology.

[23]  Russell L. Rothman,et al.  The ADAPTABLE Trial and PCORnet: Shining Light on a New Research Paradigm , 2015, Annals of Internal Medicine.

[24]  D. Lynch,et al.  The Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet): diagnostic and adjudication processes. , 2015, Chest.

[25]  Shandra L. Protzko,et al.  An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. , 2015, American journal of respiratory and critical care medicine.

[26]  W. Seeger,et al.  Streptococcus pneumoniae triggers progression of pulmonary fibrosis through pneumolysin , 2015, Thorax.

[27]  P. Donnan,et al.  The PRECIS-2 tool: designing trials that are fit for purpose , 2015, BMJ : British Medical Journal.

[28]  H. Collard,et al.  Association of hospital admission and forced vital capacity endpoints with survival in patients with idiopathic pulmonary fibrosis: analysis of a pooled cohort from three clinical trials. , 2015, The Lancet. Respiratory medicine.

[29]  B. Chowdhury,et al.  Forced vital capacity in idiopathic pulmonary fibrosis--FDA review of pirfenidone and nintedanib. , 2015, The New England journal of medicine.

[30]  A. Azuma,et al.  A Phase 3 Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis , 2015 .

[31]  S. Nathan,et al.  Outcomes after hospitalization in idiopathic pulmonary fibrosis: a cohort study. , 2015, Chest.

[32]  W. Lijfering,et al.  Link between co-trimoxazole and sudden death in patients receiving inhibitors of renin-angiotensin system could be due to confounding , 2014, BMJ : British Medical Journal.

[33]  H. Collard,et al.  Study design implications of death and hospitalization as end points in idiopathic pulmonary fibrosis. , 2014, Chest.

[34]  T. Gomes,et al.  Co-trimoxazole and sudden death in patients receiving inhibitors of renin-angiotensin system: population based study , 2014, BMJ : British Medical Journal.

[35]  Elissa Murphy,et al.  The role of bacteria in the pathogenesis and progression of idiopathic pulmonary fibrosis. , 2014, American journal of respiratory and critical care medicine.

[36]  Meilan K. Han,et al.  Lung microbiome and disease progression in idiopathic pulmonary fibrosis: an analysis of the COMET study. , 2014, The Lancet. Respiratory medicine.

[37]  R. Sussman,et al.  A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. , 2014, The New England journal of medicine.

[38]  H. Collard,et al.  Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. , 2014, The New England journal of medicine.

[39]  Joyce S Lee,et al.  Predicting survival across chronic interstitial lung disease: the ILD-GAP model. , 2014, Chest.

[40]  R. Califf.  Large simple trials: really, it can't be that simple! , 2014, European heart journal.

[41]  J. McMurray,et al.  Large streamlined trials in cardiovascular disease. , 2014, European heart journal.

[42]  Yoshiya Tanaka,et al.  Prophylaxis for Pneumocystis pneumonia in patients with rheumatoid arthritis treated with biologics, based on risk factors found in a retrospective study , 2014, Arthritis Research & Therapy.

[43]  P. Donnan,et al.  Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose , 2013, Trials.

[44]  H. Collard,et al.  Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in phase 3 clinical trials. , 2012, American journal of respiratory and critical care medicine.

[45]  E. Chilvers,et al.  Treating idiopathic pulmonary fibrosis with the addition of co-trimoxazole: a randomised controlled trial , 2012, Thorax.

[46]  R. D. du Bois,et al.  Idiopathic pulmonary fibrosis: lung function is a clinically meaningful endpoint for phase III trials. , 2012, American journal of respiratory and critical care medicine.

[47]  Moisés Selman,et al.  Idiopathic pulmonary fibrosis , 2011, The Lancet.

[48]  D. Juurlink,et al.  Considerations when prescribing trimethoprim–sulfamethoxazole , 2011, Canadian Medical Association Journal.

[49]  S. Swarnakar,et al.  An alternative therapy for idiopathic pulmonary fibrosis by doxycycline through matrix metalloproteinase inhibition , 2011, Lung India : official organ of Indian Chest Society.

[50]  P. V. van Riel,et al.  The effects of doxycycline on reducing symptoms in knee osteoarthritis: results from a triple-blinded randomised controlled trial , 2011, Annals of the rheumatic diseases.

[51]  G. Raghu,et al.  Ascertainment of individual risk of mortality for patients with idiopathic pulmonary fibrosis. , 2010, American journal of respiratory and critical care medicine.

[52]  P. Bhattacharyya,et al.  The role of long-term doxycycline in patients of idiopathic pulmonaryfibrosis: The results of an open prospective trial , 2009, Lung India : official organ of Indian Chest Society.

[53]  Ian Harvey,et al.  A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. , 2009, Journal of clinical epidemiology.

[54]  T. Peters,et al.  Valuing the ICECAP capability index for older people. , 2008, Social science & medicine.

[55]  T. Peters,et al.  An assessment of the construct validity of the descriptive system for the ICECAP capability measure for older people , 2008, Quality of Life Research.

[56]  V. Varney,et al.  A double blind randomised placebo controlled pilot study of oral co-trimoxazole in advanced fibrotic lung disease. , 2008 .

[57]  J. Leyden,et al.  Safety of doxycycline and minocycline: a systematic review. , 2005, Clinical therapeutics.

[58]  L. Sharma,et al.  Effects of doxycycline on progression of osteoarthritis: results of a randomized, placebo-controlled, double-blind trial. , 2005, Arthritis and rheumatism.

[59]  Sally J. Singh,et al.  Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ) , 2003, Thorax.

[60]  Hilde van der Togt,et al.  Publisher's Note , 2003, J. Netw. Comput. Appl..

[61]  B. Baxter,et al.  Prolonged administration of doxycycline in patients with small asymptomatic abdominal aortic aneurysms: report of a prospective (Phase II) multicenter study. , 2002, Journal of vascular surgery.

[62]  Kenneth F Schulz,et al.  Blinding in randomised trials: hiding who got what , 2002, The Lancet.

[63]  M. Perazella.  Trimethoprim-Induced Hyperkalaemia , 2000, Drug safety.

[64]  M. L. de la Mata,et al.  Randomized trial of weekly sulfadoxine/pyrimethamine vs. daily low-dose trimethoprim-sulfamethoxazole for the prophylaxis of Pneumocystis carinii pneumonia after liver transplantation. , 1999, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[65]  J. Karon,et al.  Efficacy of trimethoprim-sulphamethoxazole prophylaxis to decrease morbidity and mortality in HIV-1-infected patients with tuberculosis in Abidjan, Côte d'Ivoire: a randomised controlled trial , 1999, The Lancet.

[66]  N. Larocca,et al.  The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. , 1989, Archives of neurology.

[67]  M. Fischl,et al.  Safety and Efficacy of Sulfamethoxazole and Trimethoprim Chemoprophylaxis for Pneumocystis carinii Pneumonia in AIDS , 1988 .