This subgroup analysis of the Effisayil 1 trial (NCT03782792) compared patient characteristics and assessed effects spesolimab in patients with a GPP flare with/without baseline systemic inflammation. Patients were randomised 2:1 to single infusion IV 900 mg or placebo. Systemic inflammation at was defined as elevated CRP (>ULN 10 mg/L) neutrophil count (>ULN, 7.23x109/L). GPPGA pustulation sub...

background oral administration of pro- and prebiotics has recently been considered as an effective way for nonalcoholic fatty liver disease (nafld) recovery. objectives the current study aimed at evaluating the effect of supplementation with probiotics and/or prebiotics on liver function tests in patients with nafld. methods in this double blind, placebo-control clinical trial, 75 subjects with...

PurposeTo assess the efficacy and safety of macitentan in pts with PH post-LVAD.MethodsSOPRANO (NCT02554903) was a double-blind, randomized, study 10 mg once-daily vs placebo. Pts were ≥18 years LVAD implanted within 90 days prior to randomization, had mean pulmonary arterial pressure (mPAP) ≥25 mmHg, artery wedge (PAWP) ≤18 mmHg vascular resistance (PVR) >3 Wood units (WU). The primary endpoin...

Abstract Background EIMs are common in patients with UC and associated impaired quality of life. This analysis evaluated the impact treatment selective Janus kinase 1 inhibitor UPA on moderate-to-severe UC. Methods Data were included from two induction studies (U-ACHIEVE Induction [NCT02819635] U-ACCOMPLISH [NCT03653026]) a maintenance study Maintenance). Patients randomised 2:1 to 8 weeks’ 45 ...

Abstract Background Patients with major depressive disorder (MDD) often do not respond to antidepressant (ADT) monotherapy alone and may require adjunctive treatment provide adequate symptom relief. Cariprazine (CAR) is a dopamine D 3 -preferring /D 2 serotonin 5-HT 1A receptor partial agonist approved treat adults schizophrenia manic, mixed, or episodes of bipolar I disorder. Post hoc analysis...

OBJECTIVE The aim of this study was to investigate the efficacy and safety imeglimin, first in a new class oral antidiabetic agent, Japanese patients with type 2 diabetes. RESEARCH DESIGN AND METHODS This double-blind, randomized, parallel-group, placebo-controlled phase 3 trial 30 sites Japan. Eligible participants were individuals aged ?20 years diabetes treated diet exercise, stable for ?12 ...

Abstract Introduction In the phase 3 REST-ON trial (NCT02720744), participants with narcolepsy type 1 (NT1) treated once-nightly sodium oxybate (ON-SXB; FT218), an investigational, extended-release formulation, had significant reductions in cataplexy episodes (ON-SXB vs placebo: 4.5 g, P< 0.05 [post hoc]; 6 , 7.5, and 9 all 0.001). This post hoc responder analysis further characterized i...

statement of the problem : geographic tongue is characterized by loss of filliform papillae in an erythematous area with keratotic borders. it vanishes after a while and reappears in another area. it is relatively common and is most seen among females. considering such problems as pain, burning sensation and sharp pain in tongue, decreasing of taste sensation, cancer phobia and esthetic problem...