Project description:We present the biopsy sub-study results from the first randomized, placebo-controlled clinical trial in patients with alopecia areata (AA) with ≥50% scalp hair loss and ≤7 years since the last AA episode. In this sub-study, we evaluated the molecular responses to PF-06651600, an oral inhibitor of JAK3 and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family, and PF-06700841, an oral TYK2/JAK1 inhibitor, versus placebo in nonlesional and lesional scalp biopsies of biopsy samples from patients with AA.
Project description:The goal of this study is to define the molecular signatures of SLE patients at baseline in BMS IM101042 trial. IM101042 (NCT00119678) is a phase IIb, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of abatacept vs placebo on a background of oral glucocorticosteroids in the treatment of subjects with systemic lupus erythematosus and the prevention of subsequent lupus flares, sponsored by Bristol-Myers Squibb.
Project description:The CLARITY trial (NCT00213135) was designed as a double-blind, placebo-controlled study to allow the best comparison of absolute efficacy and safety of oral cladribine in RRMS subjects. 1326 patients with relapsing MS were randomized (1:1:1) to receive cladribine tablets 3.5 mg/kg or 5.25 mg/kg bodyweight or placebo. Gene expression data in whole blood samples at 96 weeks were prepared according to standard Affymetrix protocols Gene expression data in whole blood samples at 96 weeks were available from patients randomized to placebo (n=57), cladribine tablets 3.5 mg/kg (n=62), and cladribine tablets 5.25 mg/kg (n=70).
Project description:A randomized, double-blind, placebo-controlled trial of netazepide (YF476) in patients with BE without dysplasia was performed. Gene expression before and after treatment with netazepide and with a placebo was measured with RNASeq
2021-12-22 | GSE155665 | GEO
Project description:Synbiotic supplementation in patients with systemic lupus erythematosus: a randomized, double-blind, placebo-controlled trial
Project description:Vitamin D deficiency is a risk factor for developing multiple sclerosis (MS). Both in vitro and animal studies suggest an immunomodulatory effect of vitamin D. The PrevANZ trial, a phase IIb randomized placebo-controlled trial of oral vitamin D3 supplementation in people with a first demyelinating event (FDE), was conducted to determine if supplementation can prevent recurrent disease activity in this cohort at high risk of developing definite MS. As a sub-study of this trial, we used whole blood transcriptomic analyses to investigate the effect of vitamin D3 supplementation on peripheral immune cells in people with an FDE, and to gain insight into potential mechanisms by which vitamin D3 may regulate MS risk and disease activity. The PrevANZ trial randomized participants to 1000 IU, 5000 IU or 10,000 IU daily of oral vitamin D3 or placebo. Peripheral blood was collected at baseline and 12 weeks in PAXgene Blood RNA tubes. Transcriptomic datasets were generated by RNA sequencing.
Project description:The objective of the overall study was to determine the effects of oral vitamin D supplementation on alveolar macrophages from human subjects. In this substudy, subjects treated with vitamin D (intervention group) in paired analysis had small, but significant effects on immune-related differential gene expression pre versus post supplementation. In this study, we obtained alveolar macrophages by bronchoalveolar lavage of subjects before and after a 3 month vitamin D trial. RNA for the array was obtained shortly after bronchoscopy. Randomized Controlled Trial: This is a substudy of paired samples of subjects treated with vitamin D. Each sample was studied once. 22 individuals were studied.
Project description:To evaluate whether clarithromycin improves 28-day mortality among patients with sepsis, respiratory and multiple-organ dysfunction syndrome. The INntravenous CLArithromycin in Sepsis and multiple organ dysfunction Syndrome trial was a phase 3, randomized, double blind, placebo-controlled clinical study, conducted in 11 intensive care units and 2 Internal Medicine wards in 2 countries. Patients with sepsis, respiratory failure and total sequential organ failure assessment score of ≥7 were enrolled between December 2017 and September 2019. Follow-up lasted 90 days. Patients were randomized to receive 1 gr of intravenous clarithromycin or placebo once daily for 4 consecutive days.
Project description:IL-1 has been implicated in various fibrotic diseases. This randomized, Placebo-Controlled trial we examine the effect of il1-b inhibition on skin expression. We used microarrays to explore gene expression changes in the Rilonacept clinical trial