Study Trial design No. of patients Randomisation Outcomes assessed

Slides:

Advertisements

Similar presentations

FRISC II: Fragmin and fast Revascularization during InStability in Coronary artery disease - LONG-TERM HEPARIN - Purpose To assess efficacy of long-term.

Advertisements

The FREEDOM Study (Impact of Short Daily Hemodialysis on Restless Legs Symptoms and Sleep Disturbances) Source Jaber BL, Schiller B, Burkart JM, et al.

Clostridium difficile Prevention and Treatment Katrina Beining & Christina Gardner Introduction Clostridium difficile (C. diff) is a gram-positive, spore-forming.

Medical Management of Ulcerative Colitis Conrad Beckett Bradford Royal Infirmary M62 Course March 2006.

Tissue Plasminogen Activator for Acute Ischemic Stroke National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group.

The only end-points of therapy that matter are mucosal healing, normal blood work, and negative radiologic studies. Robert N. Baldassano, MD Colman Family.

Critical Appraisal Athar Yasin EOE - RTD Jan 2012.

How to Analyze Therapy in the Medical Literature (part 1) Akbar Soltani. MD.MSc Tehran University of Medical Sciences (TUMS) Shariati Hospital

Beckett N, Peters R, Tuomilehto J, et al. Immediate and late benefits of treating very elderly people with hypertension: results from active treatment.

Amoxicillin for Acute Rhinosinusitis A Randomized Controlled Trial Garbutt JM, Banister C, Spitznagel E, Piccirillo JF. JAMA 2012;307(7): Prof.

Occluded Artery Trial: 1° Hypothesis and Design 1° Hypothesis: Late PCI to open occluded IRA will ↓ death/reinfarction/class IV CHF by 25% compared to.

Table 1 | Fibre in diverticulosis and symptomatic diverticular disease

Journal of Microbiology, Immunology and Infection

Study Trial design No. of patients Randomisation Outcomes assessed

Study Trial design No. of patients Randomisation Outcomes assessed

LEADER trial: Primary Outcome

Proportion of patients that met the SRI-5 response criteria (A and C) and reasons for non-response (B and D) in trial 1 (A and B) and trial 2 (C and D).

Martha Carvour, MD, PhD March 2, 2017

HATSJOE Study Symptomatic treatment of pollen-related allergic rhinoconjunctivitis in children: a randomized controlled trial.

Table 1 | Fibre in diverticulosis and symptomatic diverticular disease

CANTOS: The Canakinumab Anti-Inflammatory Thrombosis Outcomes Study

FATS- Familial Atherosclerosis Treatment Study

Thadhani et al. Am J Nephrol 2017;45:40-48 (DOI: / )

Clinical Trial of Vadadustat in Patients with Anemia Secondary to Stage 3 or 4 Chronic Kidney Disease Martin et al. Am J Nephrol 2017;45: (DOI:

Volume 128, Issue 3, Pages (March 2005)

Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly or Moderately Emetogenic Chemotherapy: A Randomized,

Volume 147, Issue 4, Pages (October 2014)

CANOA Trial design: Patients undergoing percutaneous closure of an ASD with the Amplatzer Septal Occluder were randomized to aspirin 80 mg plus clopidogrel.

Consolidated Standards of Reporting Trials (CONSORT) diagram of patients enrolled in the study. #: Two pre-screen/screen failures were erroneously randomised,

Modified Rankin score 0-2

Evidenced Based Journal Club – 20th June 2007

Use of the Cumulative Proportion of Responders Analysis Graph to Present Pain Data Over a Range of Cut-Off Points: Making Clinical Trial Data More Understandable

Proportion of Patients Achieving a ≥30% Reduction in Pain Scores at Week 12 of Stable Dose Treatment

Bar charts comparing the results of ePROMs between patients who found the scores inadequately assessed their symptoms against all other patients leaving.

GI clinical research 2002–2003: the year in review

Volume 74, Issue 5, Pages (November 2018)

Gastrointestinal Effects of NSAIDs and Coxibs

Module 4 Finding the Evidence: Individual Trials

Préparation ESC Septembre

Current and emerging management options for Clostridium difficile infection: what is the role of fidaxomicin? O.A. Cornely Clinical Microbiology and.

LRC-CPPT and MRFIT Content Points:

Baseline scores and corresponding changes to week 96 of the RAPID-axSpA trial for all CZP-treated patients included in the imaging substudy for: (A) SPARCC.

Effect of Once- or Twice-Daily MMX Mesalamine (SPD476) for the Induction of Remission of Mild to Moderately Active Ulcerative Colitis Gary R. Lichtenstein,

The Research Question Background: Question:

Study design (A) and subject disposition (B).

Comparison of NNRTI vs NNRTI

Diagnostic Performance of Four-dimensional CT and Sestamibi SPECT/CT in Localizing Parathyroid Adenomas in Primary Hyperparathyroidism Combined four-dimensional.

Indications: Complicated DD after 6/52

Three outcome measures from the NINDS tPA trial

Figure 1. Changes of Clinical Symptoms Severity in patients on multi-strain probioticFlorasan-D or Placebo Ivashkin V. et al. The Effect of a Multi-strain.

This Month in Gastroenterology

Forest plots of randomised controlled trials and propensity score matched studies examining outcomes between patients taking proton pump inhibitor (PPIs)

Independent baseline predictors of non-remission at 24 months of follow-up in the SWEFOT trial population. Independent baseline predictors of non-remission.

Figure 2. Patient stratification by the reported duration of symptoms and disease severity at the time of assessment Patient stratification by the reported.

Difference in the risk of MACEs in patients treated with anti–IL17 agents compared with the placebo in RCTs. IL,interleukin; MACEs, major adverse cardiovascular.

Change in APOC3 level in response to treatment with APOC3 antisense oligonucleotide ISIS Phase 2, randomised, double-blind, placebo-controlled study.

Scoring of Coronary Artery Disease Characteristics on Coronary CT Angiograms by Using Machine Learning For prediction of all-cause mortality on the basis.

Difference in the risk of MACEs in patients treated with anti-IL23 agents compared with the placebo in RCTs. IL, interleukin; MACEs, major adverse cardiovascular.

Illustration of a trial design to help evaluate the clinical accuracy of a test of ischaemia. Illustration of a trial design to help evaluate the clinical.

Difference in the risk of MACEs in patients treated with anti-TNF agents compared with the placebo in RCTs. MACEs, major adverse cardiovascular events;

Number of patients treated at clinics that followed up fewer than 10 patients (2013–2016) or 20 patients (2012) and proportion of patients followed up.

FIM total score by study visit (ITT population).

Medical Scientific Experts

Days without gluten challenge

Increased frequency and number of KLL-specific clonotypes in tumors is associated with improved MCC-specific survival. Increased frequency and number of.

The percentage of patients with baseline BSA ≥ 3% in the ITT population who achieved (a) PASI 75, (c) PASI 90, and (e) PASI 100 during the 24-week double-blind.

Study design. Study design. Patients who completed the 8-week induction study and achieved clinical response-100 (decrease in Crohn's disease activity.

Flow of recruitment: the screening and enrolment process for a 6-week randomised double-blind placebo-controlled feasibility trial in people with multiple.

ACR20 (A), ACR50 (B) and MDA (C) response rates at 24 weeks in patients treated with PBO, IXEQ4W or IXEQ2W alone or when added to background cDMARDs or.

(A) Short Health Scale (SHS) dimension scores (left) and Psychological General Well-Being Index (PGWBI) global scores (right) for the open-label phase.

Presentation transcript:

Table 3 | Fully published placebo-controlled trials in using mesalazine in diverticular disease Study Trial design No. of patients Randomisation Outcomes assessed Length of follow-up Results Kruis et al. Double-blind, randomised, Placebo controlled 117 Mesalazine granules 3 g/day vs. Placebo in SUDD Pain control in SUDD 4 Mesalazine had higher percentage of pain control (62.5% vs. 50.81%, P = 0.374 on ITT and P = 0.05 on PP) Tursi 210 Mesalazine Eudragit L 2.4 g/day vs. Mesalazine 2.4 g/day + Lactobacillus casei 750 mg/day vs. Lactobacillus casei 750 mg/day vs. placebo Reducing gastrointestinal Symptoms in SUDD Preventing diverticulitis occurrence 12 Mesalazine, alone or in combination, had high remission rate (93.33% and 85.45% vs. 54%, P = 0.0001)*. Mesalazine, alone or in combination, had lower diverticulitis occurrence (0% and 1.81% vs. 12%, P = 0.003)* Stollman Mesalazine Eudragit L 2.4 g/day vs. Mesalazine 2.4 g/day + Bifidobacterium infantis 35624 vs. placebo following acute diverticulitis Reducing gastrointestinal symptoms Preventing diverticulitis recurrence Mesalazine, alone or in combination, had higher symptoms’ improvement rate (59.3% and 54.8% vs. 27.3%, P = 0.0346)*. Mesalazine, alone or in combination, had no higher remission rate in preventing diverticulitis recurrence (28.1%, 37% vs. 31% placebo, P = n.s.)* Parente 92 Mesalazine Eudragit L 2.4 g/day for 10 days/month vs. placebo following acute diverticulitis Improvement quality of life 24 Mesalazine had higher but no significant remission rate in preventing diverticulitis recurrence (13% vs. 28%, P = 0.1011)*. Mesalazine had higher quality of life score (P = 0.022)* Raskin 1182 (590 in PREVENT1 and 592 in PREVENT 2) Mesalazine MMX 1.6 g/day vs. 2.4 g/day vs. 4.8 g/day vs. placebo following acute diverticulitis Preventing diverticulitis Mesalazine did not reduce the rate of diverticulitis recurrence both in PREVENT 1 (53–63% vs. 65%, P = n.s.)* and in PREVENT 2 (59–69% vs. 68%, P = n.s.)* ITT, intention-to-treat analysis; PP, per-protocol analysis; SUDD, Symptomatic Uncomplicated Diverticular Disease. *All results reported are on ITT analysis.