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Clinical trials in ibd

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https://www.readbyqxmd.com/read/27881284/perceived-risks-contra-benefits-of-using-biosimilar-drugs-in-ulcerative-colitis-discrete-choice-experiment-among-gastroenterologists
#1
Petra Baji, László Gulácsi, Petra A Golovics, Barbara D Lovász, Márta Péntek, Valentin Brodszky, Fanni Rencz, Péter L Lakatos
BACKGROUND: In middle-income countries, access to biological therapy is limited in ulcerative colitis in terms of the number of patients and the length of therapy. Because of their cost advantages, biosimilars have the potential to improve access to therapy, but physicians have concerns toward their use because of the lack of evidence from randomized clinical trials. OBJECTIVES: To explore the preferences of gastroenterologists for biosimilar drugs in ulcerative colitis as well as to compare our results with results of previous studies on gastroenterologists' preferences toward biosimilars...
September 2016: Value in Health Regional Issues
https://www.readbyqxmd.com/read/27878827/review-article-mesenchymal-stromal-cell-therapy-for-inflammatory-bowel-diseases
#2
REVIEW
C Grégoire, C Lechanteur, A Briquet, É Baudoux, F Baron, E Louis, Y Beguin
BACKGROUND: Inflammatory bowel diseases (IBD) are chronic relapsing diseases in which pro-inflammatory immune cells and cytokines induce intestinal tissue damage and disability. Mesenchymal stromal cells (MSCs) exert powerful immunomodulatory effects and stimulate tissue repair. AIM: To review the current data on mesenchymal stromal cell therapy in IBD. METHOD: We searched PubMed and 'ClinicalTrials.gov' databases using the terms 'mesenchymal stromal cells', 'mesenchymal stem cell transplantation', 'inflammatory bowel diseases', 'Crohn disease' and 'colitis, ulcerative'...
November 22, 2016: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27859410/effects-of-vedolizumab-on-health-related-quality-of-life-in-patients-with-ulcerative-colitis-results-from-the-randomised-gemini-1-trial
#3
B G Feagan, H Patel, J-F Colombel, D T Rubin, A James, R Mody, K Lasch
BACKGROUND: Health-related quality of life (HRQL) is often diminished in patients with ulcerative colitis. AIM: To evaluate the effects of vedolizumab on HRQL in patients with ulcerative colitis. METHODS: Using maintenance phase data from the GEMINI 1 study, an analysis of covariance model was used to calculate mean differences between the vedolizumab and placebo groups in changes from baseline to week 52 for 3 HRQL instruments: The Inflammatory Bowel Disease Questionnaire (IBDQ), 36-Item Short Form Health Survey (SF-36), and EQ-5D...
November 17, 2016: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27859024/medical-cannabis-another-piece-in-the-mosaic-of-autoimmunity
#4
D Katz, I Katz, B S Porat-Katz, Y Shoenfeld
Legalization of cannabis' medicinal use is rapidly increasing worldwide, raising the need to evaluate medical implications of cannabis. Currently evidence supports cannabis and its active ingredients as an immune-modulating agents, affecting T-cells, B-cells, Monocytes and Microglia-cells, causing an overall reduction in pro-inflammatory cytokine expression and an increase in anti-inflammatory cytokines. Due to the supporting evidence of cannabinoids as an immune-modulating agent, research focusing on cannabinoids and autoimmunity has emerged...
November 10, 2016: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27845055/is-stem-cell-therapy-ready-for-prime-time-in-treatment-of-inflammatory-bowel-diseases
#5
Christopher J Hawkey, Daniel W Hommes
Autologous hematopoietic stem cell transplantation (HSCT) and mesenchymal stromal cell therapy (MSCT) have been proposed for patients with refractory Crohn's disease (CD) and fistulizing CD respectively. Will these highly advanced techniques be available only for select patients, at specialized centers, or is further clinical development justified, with the aim of offering widespread, more definitive therapeutic options for often very difficult to treat disease? Patients with CD who are eligible for HSCT have typically been failed by most approved therapies, have undergone multiple surgeries, and have coped with years of disease activity and poor quality of life...
November 11, 2016: Gastroenterology
https://www.readbyqxmd.com/read/27834121/demineralized-freeze-dried-bone-allograft-with-amniotic-membrane-in-the-treatment-of-periodontal-intrabony-defects-12-month-randomized-controlled-clinical-trial
#6
Deepthi D Sali, Joann Pauline George
AIM: The goal of randomized controlled clinical study was to compare the clinical and radiological outcomes of the combination of Open flap debridement, Amniotic membrane and Demineralized Freeze Dried bone Allograft with Open flap debridement and Demineralized Freeze Dried bone Allograft alone in the management of periodontal intrabony defects. METHOD: 10 patients with bilaterally similar intrabony defects were selected. Each of the intrabony defects were randomly allocated for control and test groups...
November 11, 2016: Journal of Periodontology
https://www.readbyqxmd.com/read/27802156/recent-advances-in-clinical-practice-a-systematic-review-of-isolated-colonic-crohn-s-disease-the-third-ibd
#7
REVIEW
Sreedhar Subramanian, Anders Ekbom, Jonathan M Rhodes
The genetics of isolated colonic Crohn's disease place it approximately midway between Crohn's disease with small intestinal involvement and UC, making a case for considering it as a separate condition. We have therefore systematically reviewed its epidemiology, pathophysiology and treatment. Key findings include a higher incidence in females (65%) and older average age at presentation than Crohn's disease at other sites, a mucosa-associated microbiota between that found in ileal Crohn's disease and UC, no response to mesalazine, but possibly better response to antitumour necrosis factor than Crohn's disease at other sites...
October 6, 2016: Gut
https://www.readbyqxmd.com/read/27797917/patient-reported-outcome-measures-proms-in-inflammatory-bowel-disease-new-data
#8
Daniela Bojic, Keith Bodger, Simon Travis
Patient reported outcome measures PROMs are standardized, validated questionnaires intended for completion by patients in order to measure their perceptions of their own health condition or its treatment without interpretation of the patient's response by a clinician or anyone else. Mayo Clinic Score (MCS) or Crohn's Disease Activity Index (CDAI), most frequently used as endpoints in conventional clinical trials, are composite instruments that are not fully objective nor capture the impact of disease from the patient's perspective...
October 21, 2016: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/27785085/treatment-challenges-in-the-management-of-moderate-to-severe-plaque-psoriasis-role-of-secukinumab
#9
REVIEW
Mona Malakouti, Sharon E Jacob, Nancy J Anderson
Psoriasis is a chronic inflammatory skin disease that has a negative impact on psychosocial well-being and cardiometabolic health. Treatment options for moderate-to-severe psoriasis have expanded with the development of interleukin-17 (IL-17) inhibitors, the first of which is now available - secukinumab. Secukinumab is a fully human monoclonal immunoglobulin G1 κ antibody that selectively inhibits the ligand IL-17A. In head-to-head studies, it is more effective than etanercept and ustekinumab, particularly in achieving Psoriasis Area and Severity Index (PASI) 90/100 and achieving PASI 50/75 as early as week 4...
2016: Clinical, Cosmetic and Investigational Dermatology
https://www.readbyqxmd.com/read/27783851/regenerative-potential-of-leucocyte-and-platelet-rich-fibrin-l-prf-part-a-intrabony-defects-furcation-defects-and-periodontal-plastic-surgery-a-systematic-review-and-meta-analysis
#10
REVIEW
Ana B Castro, Nastaran Meschi, Andy Temmerman, Nelson Pinto, Paul Lambrechts, Wim Teughels, Marc Quirynen
AIM: To analyse the regenerative potential of Leucocyte- and Platelet Rich Fibrin (L-PRF) during periodontal surgery. MATERIALS AND METHODS: An electronic and hand search were conducted in three databases. Only randomised clinical trials were selected and no follow-up limitation was applied. Pocket depth (PD), clinical attachment level (CAL), bone fill, keratinized tissue width (KTW), recession reduction, and root coverage (%) were considered as outcome. When possible, meta-analysis was performed...
October 26, 2016: Journal of Clinical Periodontology
https://www.readbyqxmd.com/read/27780712/lessons-learned-from-trials-targeting-cytokine-pathways-in-patients-with-inflammatory-bowel-diseases
#11
Clara Abraham, Parambir S Dulai, Séverine Vermeire, William J Sandborn
Insights into the pathogenesis of inflammatory bowel diseases (IBD) have provided important information for the development of therapeutics. Levels of interleukin 23 (IL23) and T-helper (Th) 17 cell pathway molecules are elevated in inflamed intestinal tissues of patients with IBD. Loss of function variants of the interleukin 23 receptor gene (IL23R) protect against IBD, and in animals, blocking IL23 reduces severity of colitis. These findings indicated that the IL23 and Th17 cell pathways might be promising targets for treatment of IBD...
October 22, 2016: Gastroenterology
https://www.readbyqxmd.com/read/27749233/clinical-course-and-outcomes-of-childhood-onset-granulomatosis-with-polyangiitis
#12
Karen E James, Rui Xiao, Peter A Merkel, Pamela F Weiss
OBJECTIVES: To characterise the clinical course and outcomes of a cohort of children with granulomatosis with polyangiitis (GPA). METHODS: Retrospective cohort study of children diagnosed with GPA in a tertiary care facility from 2000-2014. All subjects met the American College of Rheumatology 1990 criteria for GPA or the 2008 European League against Rheumatism/Paediatric Rheumatology International Trials Organisation/Paediatric Rheumatology European Society criteria for GPA...
October 6, 2016: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/27732736/withdrawn-transcutaneous-electrical-stimulation-tes-for-treatment-of-constipation-in-children
#13
REVIEW
Ruey Terng Ng, Way Seah Lee, Hak Lee Ang, Kai Ming Teo, Yee Ian Yik, Nai Ming Lai
BACKGROUND: Childhood constipation is a common problem with substantial health, economic and emotional burdens. Existing therapeutic options, mainly pharmacological, are not consistently effective, and some are associated with adverse effects after prolonged use. Transcutaneous electrical stimulation (TES), a non-pharmacological approach, is postulated to facilitate bowel movement by modulating the nerves of the large bowel via the application of electrical current transmitted through the abdominal wall...
October 12, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27725645/histological-disease-activity-as-a-predictor-of-clinical-relapse-among-patients-with-ulcerative-colitis-systematic-review-and-meta-analysis
#14
Sunhee Park, Tsion Abdi, Mark Gentry, Loren Laine
OBJECTIVES: Endoscopic remission in ulcerative colitis (UC) is associated with improved clinical outcomes. We assessed whether histological remission predicts clinical outcomes, estimated the magnitude of effect, and determined whether histological remission provides additional prognostic utility beyond clinical or endoscopic remission. METHODS: Bibliographic databases were searched for studies in inflammatory bowel disease providing baseline histological status and relation to an outcome of clinical relapse or exacerbation...
October 11, 2016: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/27724045/p2x7-receptor-antagonists-a-patent-review-2010-2015
#15
Jin-Hee Park, Yong-Chul Kim
The P2X7 receptor (P2X7R) is a unique subtype among the family of seven purinergic P2X receptors, which are ATP-gated non-selective cation channels. P2X7R has been reported to have pathological roles in various diseases, including autoimmune diseases such as arthritis and inflammatory bowel disease, neurodegenerative diseases, chronic pain, mood disorders and cancers. Therefore, many pharmaceutical companies have endeavored to develop a clinical candidate targeting P2X7R. Areas covered: This review provides a summary of various patents on chemicals and biologics and their clinical use published between 2010 and 2015...
October 10, 2016: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/27723903/motivation-of-patients-with-inflammatory-bowel-disease-to-participate-in-a-clinical-trial
#16
U Gehrmann, U Berger, N Teich, T Bruns, A Stallmach, M Weber
Background: Clinical trials are designed to investigate innovative diagnostic and therapeutic strategies for patients. However, factors that influence patients with inflammatory bowel disease (IBD) and willingness to participate in a clinical trial are unknown. Methods: We developed a questionnaire and asked IBD patients about their willingness to hypothetically participate in a clinical trial and their current health-related quality of life by using the IBDQ. Results: Of 201 distributed questionnaires, 166 were returned and included in the analysis...
October 2016: Zeitschrift Für Gastroenterologie
https://www.readbyqxmd.com/read/27716258/rifaximin-is-an-effective-alternative-to-metronidazole-for-the-treatment-of-chronic-enteropathy-in-dogs-a-randomised-trial
#17
Alessandro Menozzi, Manuel Dall'Aglio, Fausto Quintavalla, Luca Dallavalle, Valentina Meucci, Simone Bertini
BACKGROUND: A clinical trial was conducted in order to assess the efficacy of rifaximin, a broad-spectrum antibiotic with negligible gastrointestinal absorption, in comparison with metronidazole, a commonly employed antimicrobial drug, in dogs with chronic enteropathy. Twenty-four pet dogs were randomly enrolled into two different groups: MET group (10 dogs) and RIF group (14 dogs). Dogs of MET group received metronidazole 15 mg/kg q12h for 21 days by oral route, whereas dogs of RIF group, were given rifaximin 25 mg/kg q12h for 21 days by oral route...
October 6, 2016: BMC Veterinary Research
https://www.readbyqxmd.com/read/27714831/vedolizumab-provides-clinical-benefit-over-1-year-in-patients-with-active-inflammatory-bowel-disease-a-prospective-multicenter-observational-study
#18
A Stallmach, C Langbein, R Atreya, T Bruns, A Dignass, K Ende, J Hampe, F Hartmann, M F Neurath, J Maul, J C Preiss, R Schmelz, B Siegmund, H Schulze, N Teich, U von Arnim, D C Baumgart, C Schmidt
BACKGROUND: Vedolizumab, a monoclonal antibody targeting the α4β7-integrin, is effective in inducing and maintaining clinical remission in Crohn's disease and ulcerative colitis according to randomised clinical trials. AIM: To determine the long-term effectiveness of vedolizumab in a real-world clinical setting. METHODS: This observational registry assessed the clinical outcome in patients treated with vedolizumab for clinically active Crohn's disease (n = 67) or ulcerative colitis (n = 60)...
December 2016: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27712462/mandibular-degree-ii-furcation-defects-treatment-with-platelet-rich-fibrin-and-1-alendronate-gel-combination-a-randomized-controlled-clinical-trial
#19
Dr Dharmendra Kanoriya, Dr A R Pradeep, Dr Vibhuti Garg, Dr Sandeep Singhal
BACKGROUND: Different materials have been instigated for renewal of lost supporting periodontal structures and tested for furcation defects treatment. Platelet-rich fibrin (PRF) is a pool of growth promoting factors and cytokines which promotes bone regeneration and maturation of soft tissue. Alendronate (ALN), an influential member of bisphosphonate group is known to enhance osteoblastogenesis and inhibits osteoclastic bone resorption, thus promoting tissue regeneration. This randomized trial was done to assess the effectiveness of PRF and 1% ALN gel combination in mandibular degree II furcation defects treatment in comparison to PRF and access therapy alone...
October 7, 2016: Journal of Periodontology
https://www.readbyqxmd.com/read/27708508/fast-track-drug-approval-in-inflammatory-bowel-diseases
#20
Konstantinos H Katsanos, Efstratios Koutroumpakis, Eftychia Giagkou, Zikos Malakos, Eleni Almpani, Alexandros Skamnelos, Dimitrios K Christodoulou
Fast-track drug designation of safe regimens represents an emerging method of development and approval of new medications targeting debilitating diseases including inflammatory bowel diseases (IBD). The goal of accelerated drug approval pathways is to shorten the time between application and approval of therapies that treat diseases with significant morbidity and mortality. Recently, fast-track drug approval approaches were supported by data deriving from central reading of images, a method of clinical data interpretation that has significantly benefited patients with gastrointestinal disorders...
October 2016: Annals of Gastroenterology: Quarterly Publication of the Hellenic Society of Gastroenterology
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