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Khanna, dinesh

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https://www.readbyqxmd.com/read/29099620/reliability-and-minimal-clinically-important-differences-of-forced-vital-capacity-results-from-the-scleroderma-lung-studies-sls-i-and-sls-ii
#1
Suzanne Kafaja, Philip J Clements, Holly Wilhalme, Chi-Hong Tseng, Daniel E Furst, Grace Hyun Kim, Jonathan Goldin, Elizabeth R Volkmann, Michael D Roth, Donald P Tashkin, Dinesh Khanna
OBJECTIVES: To assess the reliability and the minimal clinically important differences (MCID) for FVC% predicted in the Scleroderma Lung Study I and II. METHODS: Using data from SLS I and II (N=300), we evaluated the test-retest reliability for FVC% predicted (FVC%; screening vs. baseline) using intra-class correlation (ICC). MCID estimates at 12 months were calculated in the pooled cohort (SLS-I and II) using 2 anchors: Transition Dyspnea Index (≥change of 1...
November 3, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/29077900/patient-acceptable-symptom-state-in-scleroderma-results-from-the-tocilizumab-compared-with-placebo-trial-in-active-diffuse-cutaneous-systemic-sclerosis
#2
Michael B Arnold, Dinesh Khanna, Christopher P Denton, Jacob M van Laar, Tracy M Frech, Marina E Anderson, Murray Baron, Lorinda Chung, Gerhard Fierlbeck, Santhanam Lakshminarayanan, Yannick Allanore, Gabriela Riemekasten, Virginia Steen, Ulf Müller-Ladner, Helen Spotswood, Laura Burke, Jeffrey Siegel, Angelika Jahreis, Daniel E Furst, Janet E Pope
Objectives: Patient acceptable symptom state (PASS) as an absolute state of well-being has shown promise as an outcome measure in many rheumatologic conditions. We aimed to assess whether PASS may be effective in active diffuse cutaneous SSc differentiating active from placebo. Methods: Data from the phase 2 Safety and Efficacy of Subcutaneous Tocilizumab in Adults with Systemic Sclerosis (faSScinate) trial were used, which compared tocilizumab (TCZ) vs placebo over 48 weeks followed by an open-label TCZ period to 96 weeks...
October 25, 2017: Rheumatology
https://www.readbyqxmd.com/read/29066464/safety-and-efficacy-of-subcutaneous-tocilizumab-in-systemic-sclerosis-results-from-the-open-label-period-of-a-phase-ii-randomised-controlled-trial-fasscinate
#3
Dinesh Khanna, Christopher P Denton, Celia Jf Lin, Jacob M van Laar, Tracy M Frech, Marina E Anderson, Murray Baron, Lorinda Chung, Gerhard Fierlbeck, Santhanam Lakshminarayanan, Yannick Allanore, Janet E Pope, Gabriela Riemekasten, Virginia Steen, Ulf Müller-Ladner, Helen Spotswood, Laura Burke, Jeffrey Siegel, Angelika Jahreis, Daniel E Furst
OBJECTIVES: Assess the efficacy and safety of tocilizumab in patients with systemic sclerosis (SSc) in a phase II study. METHODS: Patients with SSc were treated for 48 weeks in an open-label extension phase of the faSScinate study with weekly 162 mg subcutaneous tocilizumab. Exploratory end points included modified Rodnan Skin Score (mRSS) and per cent predicted forced vital capacity (%pFVC) through week 96. RESULTS: Overall, 24/44 (55%) placebo-tocilizumab and 27/43 (63%) continuous-tocilizumab patients completed week 96...
October 24, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/29061853/factors-associated-with-disease-progression-in-early-diagnosed-pulmonary-arterial-hypertension-associated-with-systemic-sclerosis-longitudinal-data-from-the-detect-cohort
#4
Carina Mihai, Milos Antic, Rucsandra Dobrota, Diana Bonderman, Harbajan Chadha-Boreham, John Gerry Coghlan, Christopher P Denton, Martin Doelberg, Ekkehard Grünig, Dinesh Khanna, Vallerie V McLaughlin, Ulf Müller-Ladner, Janet E Pope, Daniel M Rosenberg, James R Seibold, Madelon C Vonk, Oliver Distler
OBJECTIVE: Pulmonary arterial hypertension (PAH) is a severe complication of systemic sclerosis (SSc). In this longitudinal study, we aimed to identify factors associated with an unfavourable outcome in patients with SSc with early PAH (SSc-PAH) from the DETECT cohort. METHODS: Patients with SSc-PAH enrolled in DETECT were observed for up to 3 years. Associations between cross-sectional variables and disease progression (defined as the occurrence of any of the following events: WHO Functional Class worsening, combination therapy for PAH, hospitalisation or death) were analysed by univariable logistic regression...
October 23, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28992174/interstitial-lung-disease-points-to-consider-for-clinical-trials-in-systemic-sclerosis
#5
REVIEW
Dinesh Khanna, James Seibold, Jonathan Goldin, Donald P Tashkin, Daniel E Furst, Athol Wells
Interstitial lung disease causes major morbidity and mortality in patients with systemic sclerosis (SSc-ILD). Large randomized clinical trials in SSc-ILD have provided important information regarding the feasibility, reliability and validity of outcome measures. Forced vital capacity percentage predicted should be considered as a primary outcome measure, with inclusion of appropriate radiological and patient-reported measures. We provide practical recommendations for trial design in SSc-ILD.
September 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28992173/assessment-of-skin-involvement-in-systemic-sclerosis
#6
REVIEW
Gábor Kumánovics, Márta Péntek, Sangmee Bae, Daniela Opris, Dinesh Khanna, Daniel E Furst, László Czirják
Skin involvement in SSc is an important marker of disease activity, severity and prognosis, making the assessment of skin a key issue in SSc clinical research. We reviewed the published data assessing skin involvement in clinical trials and summarized the major conclusions important in SSc clinical research. A systematic literature review identified randomized controlled trials using skin outcomes in SSc. Analysis examined the validity of the different skin measures based on literature findings. Twenty-two randomized controlled trials were found...
September 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28992172/points-to-consider-in-renal-involvement-in-systemic-sclerosis
#7
REVIEW
Felice Galluccio, Ulf Müller-Ladner, Daniel E Furst, Dinesh Khanna, Marco Matucci-Cerinic
This article discusses points to consider when undertaking a clinical trial to test therapy for renal involvement in SSc, not including scleroderma renal crisis. Double-blind, randomized controlled trials vs placebo or standard background therapy should be strongly considered. Inclusion criteria should consider a pre-specified range of renal functions or stratification of renal function. Gender and age limitations are probably not necessary. Concomitant medications including vasodilators, immunosuppressants and endothelin receptor antagonists and confounding illnesses such as diabetes, kidney stones, hypertension and heart failure need to be considered...
September 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28992171/points-to-consider-for-skin-ulcers-in-systemic-sclerosis
#8
REVIEW
Felice Galluccio, Yannick Allanore, Lázló Czirjak, Daniel E Furst, Dinesh Khanna, Marco Matucci-Cerinic
This article discusses points to consider when undertaking a clinical trial to test therapy for skin ulcers in SSc. A validated definition of skin ulcers should be used if available. Defining a uniform SSc patient population, including consideration of disease duration, history of digital ulcers and capillaroscopic patterns, is important. Excluding confounding factors such as infection, calcinosis and trauma should be strongly considered, or at least accounted for, in defining patients. Outcome measures such as time to healing, prevention of new ulcers, function, pain and objective measures such as US, laser Doppler and thermography can be considered as outcome measures, although their validation has not yet been achieved and efforts may be needed to validate them before use...
September 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28992170/points-to-consider-raynaud-s-phenomenon-in-systemic-sclerosis
#9
REVIEW
Maurizio Cutolo, Vanessa Smith, Daniel E Furst, Dinesh Khanna, Ariane L Herrick
RP is an exaggerated vasospastic response to cold or emotion. Randomized, double-blind, placebo-controlled trials with either parallel group or cross-over trials should be mainly considered. Cross-over design, which is good for early phase trials of immediate or very short-term outcomes, is important in a condition as heterogeneous as RP: a wash-out period between treatment arms should always be included to minimize the possibility of a period (carry-over) effect. Duration of RP trials is usually constrained by the need to complete these over a single season, usually winter when the weather is colder...
September 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28992169/points-to-consider-when-doing-a-trial-primarily-involving-the-heart
#10
REVIEW
Yannick Allanore, Oliver Distler, Ulrich A Walker, Dinesh Khanna, Daniel E Furst, Christophe Meune
Cardiac involvement contributes to the severity of SSc and should carefully be investigated and managed in SSc patients. Although it is commonly sub-clinical, once symptomatic it has a poor prognosis. Several complementary tools (circulating biomarkers, electrocardiography, echocardiography, scintigraphy or MRI) allow the assessment of all the various cardiac structures (endocardium, myocardium and pericardium) and heart function. Treatment remains empirical but cardiac trials in SSc can add data to the treatment of this complication...
September 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28992168/pulmonary-hypertension-related-to-systemic-sclerosis-points-to-consider-for-clinical-trials
#11
REVIEW
Marc Humbert, Manjit Singh, Daniel E Furst, Dinesh Khanna, James R Seibold
There are proven successful approaches to clinical trial design in pulmonary arterial hypertension (PAH), which in turn have led to the licensing of a number of effective therapies. SSc has been included in trials of World Health Organization Group 1 PAH but has been under-represented. Responses in outcomes as diverse as exercise capacity, quality of life, durability of drug effect and survival have been reduced in comparison with those seen in idiopathic PAH. The PAH community has achieved international and interdisciplinary consensus guidelines for future studies...
September 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28992167/muscle-involvement-in-systemic-sclerosis-points-to-consider-in-clinical-trials
#12
REVIEW
Ulrich A Walker, Philip J Clements, Yannick Allanore, Oliver Distler, Chester V Oddis, Dinesh Khanna, Daniel E Furst
SSc is clinically and pathogenetically heterogeneous. Consensus standards for trial design and outcome measures are needed. International experts experienced in SSc clinical trial design and a researcher experienced in systematic literature review screened the PubMed and Cochrane Central Register of Controlled Trials in order to develop points to consider when planning a clinical trial for muscle involvement in SSc. The experts conclude that SSc-associated muscle involvement is heterogeneous and lacks a universally accepted gold-standard for measuring therapeutic response...
September 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28992166/points-to-consider-for-clinical-trials-of-the-gastrointestinal-tract-in-systemic-sclerosis
#13
REVIEW
Daniel E Furst, Yolanda Braun-Moscovic, Dinesh Khanna
The pathogenesis of gastrointestinal tract involvement in SSc is not fully understood. However, gastrointestinal signs and symptoms are very common. Trials to test therapies, with rare exceptions, should be double-blind, randomized trials with either active therapy or placebo as comparators. Trial duration will vary dependent on the anticipated therapy and should usually be 6-24 weeks long, although some motility trials may need to be 52 weeks. As in any well-controlled trial, inclusion and exclusion criteria should encourage relatively uniform patients with sufficiently active disease to discern response, importantly considering disease duration...
September 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28992165/points-to-consider-for-designing-trials-in-systemic-sclerosis-patients-with-arthritic-involvement
#14
REVIEW
Philip Clements, Yannick Allanore, Daniel E Furst, Dinesh Khanna
Although musculoskeletal involvement is quite common in SSc (arthritic in particular), there have been few trials and even fewer controlled trials of therapeutic agents in arthritis in SSc. In addition, there have been only three outcome measures that have been validated for use in trials of SSc arthritis: the HAQ Disability Index, the Cochin Hand Function Scale and the Hand Mobility in SSc scale. The purpose of this article is to present evidence-based points to consider for the design of trials in SSc patients with musculoskeletal involvement (joints in particular)...
September 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28992164/functional-disability-and-other-health-related-quality-of-life-domains-points-to-consider-for-clinical-trials-in-systemic-sclerosis
#15
REVIEW
Dinesh Khanna, Ron D Hays, Daniel E Furst
Patients with SSc have the highest mortality among the rheumatic diseases. In addition, SSc is associated with disfigurement, hand contractures, fatigue, poor sleep, severe RP with numbness and tingling of the fingers can lead to decrements in quality of life. This Points to Consider article provides practical considerations for design of trials for functional disability and other health-related quality-of-life issues.
September 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28983738/establishing-clinical-severity-for-promis-%C3%A2-measures-in-adult-patients-with-rheumatic-diseases
#16
Vivek Nagaraja, Constance Mara, Puja P Khanna, Rajaie Namas, Amber Young, David A Fox, Timothy Laing, William J McCune, Carol Dodge, Debra Rizzo, Maha Almackenzie, Dinesh Khanna
PURPOSE: Different patient-reported outcome (PRO) measures are used for rheumatic diseases (RD). The aims of this study are-(1) Identify PROMIS(®) domains most relevant to care of patients with RD, (2) Collect T-Score metrics in patients with RD, and (3) Identify clinically meaningful cut-points for these domains. METHODS: A convenience sample of RD patients was recruited consecutively during clinic visits, and asked to complete computer-adaptive tests on thirteen Patient-Reported Outcomes Measurement Information System (PROMIS(®)) instruments...
October 5, 2017: Quality of Life Research
https://www.readbyqxmd.com/read/28968684/scleroderma-keratinocytes-promote-fibroblast-activation-independent-of-transforming-growth-factor-beta
#17
Sara S McCoy, Tamra J Reed, Celine C Berthier, Pei-Suen Tsou, Jianhua Liu, Johann E Gudjonsson, Dinesh Khanna, J Michelle Kahlenberg
Objectives: SSc is a devastating disease that results in fibrosis of the skin and other organs. Fibroblasts are a key driver of the fibrotic process through deposition of extracellular matrix. The mechanisms by which fibroblasts are induced to become pro-fibrotic remain unclear. Thus, we examined the ability of SSc keratinocytes to promote fibroblast activation and the source of this effect. Methods: Keratinocytes were isolated from skin biopsies of 9 lcSSc, 10 dcSSc and 13 control patients...
November 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28625944/intractable-ictal-vomiting-a-new-form-of-reflex-epilepsy
#18
Sachin Sureshbabu, Dinesh Nayak, Vikash Aggarwal, Sudhir Peter, Laxmi Khanna, Gaurav Mittal
In this description of the clinical course of a young female with persistent and protracted vomiting along with occasional loss of consciousness and subtle motor manifestations, the differential diagnosis is debated. The epileptic origin of her symptoms was substantiated by the presence of interictal epileptiform discharges and dramatic response to valproate monotherapy. Possible lobar localizations are discussed with the support of existing literature on this rare ictal manifestation [Published with video sequence on www...
June 19, 2017: Epileptic Disorders: International Epilepsy Journal with Videotape
https://www.readbyqxmd.com/read/28597604/lesinurad-a-selective-uric-acid-reabsorption-inhibitor-in-combination-with-febuxostat-in-patients-with-tophaceous-gout-findings-of-a-phase-iii-clinical-trial
#19
RANDOMIZED CONTROLLED TRIAL
Nicola Dalbeth, Graeme Jones, Robert Terkeltaub, Dinesh Khanna, Jeff Kopicko, Nihar Bhakta, Scott Adler, Maple Fung, Chris Storgard, Scott Baumgartner, Fernando Perez-Ruiz
OBJECTIVE: To investigate the efficacy and safety of lesinurad in combination with febuxostat in a 12-month phase III trial in patients with tophaceous gout. METHODS: Patients with serum urate (UA) ≥8.0 mg/dl (≥6.0 mg/dl with urate-lowering therapy) and ≥1 measurable target tophus were given febuxostat 80 mg/day for 3 weeks before randomization to receive lesinurad (200 or 400 mg daily) or placebo in addition to the febuxostat. The primary end point was the proportion of patients achieving a serum UA level of <5...
September 2017: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/28569193/health-care-utilization-in-patients-with-gout-a-prospective-multicenter-cohort-study
#20
Jasvinder A Singh, Aseem Bharat, Dinesh Khanna, Cleopatra Aquino-Beaton, Jay E Persselin, Erin Duffy, David Elashoff, Puja P Khanna
BACKGROUND: All published studies of health care utilization in gout have been cross-sectional to date, and most used a patient-reported diagnosis of gout. Our objective was to assess health care utilization and its predictors in patients with physician-confirmed gout in a prospective cohort study. METHODS: In a multi-center prospective cohort study of U.S. veterans with rheumatologist-confirmed gout (N = 186; two centers), we assessed patient self-reported overall and gout-specific health care utilization with the Gout Assessment Questionnaire (GAQ) every 3-months for a 9-month period...
May 31, 2017: BMC Musculoskeletal Disorders
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