Drug development company RegeneRx Biopharmaceuticals Inc (OTCQB: RGRX) said on Monday that its licensee has enrolled its first patient with epidermolysis bullosa (EB) under its single-blinded
, phase 2 clinical trial of the novel topically-administered drug candidate RGN-137.
A newly published article in Lancet Gastroenterology & Hepatology entitled "Optimal dilation time for combined small endoscopic sphincterotomy and balloon dilation for common bile duct stones: a multicentre, single-blinded
, randomised controlled trial" assessed the optimal duration of dilation for combined EST and EPBD for the removal of common bile duct stones (7).
Data source: A randomized, single-blinded
, split-face study of 20 patients.
They carried out a single-blinded
randomised clinical trial between November 2004 and June 2006, looking at the treatment of all episodes of uncomplicated malaria in children in an urban community in Kampala, Uganda.
Study design Randomized controlled trial (single-blinded
Research: The single-blinded
, placebo-controlled study was conducted amongst 131 subjects with high-normal blood pressure or mild hypertension to investigate the efficacy of hydrolyzed casein containing two dairy peptides, isoleucine-proline-proline (IPP) and valine-proline-proline (VPP) in reducing blood pressure.
The patients in this single-blinded
, prospective study all used the Clarion CII cochlear implant.
Sellas Life Sciences announced final results from the efficacy and safety data analysis of the prospective, randomized, single-blinded
, controlled Phase 2b independent investigator-sponsored clinical trial of the combination of trastuzumab +/- nelipepimut-S targeting HER2 low-expressing breast cancer patient cohorts, including triple-negative breast cancer, or TNBC, patients, which were presented at the 2019 ASCO-SITC symposium.
This first cohort of the Pathway Study was designed to assess the safety, and preliminary signs of efficacy, of cell administration into the cervical cord and select the dose level for the 40-patient second cohort, a randomized, controlled and single-blinded
arm of the trial, which is already underway.
The objective of the single-blinded
, first in human study is to evaluate the safety, reactogenicity and immunogenicity of the vaccine at two doses, with or without adjuvant, in 40 healthy naive volunteers.
CONCLUSIONS: In this randomized, single-blinded
study, EECP improved exercise tolerance, quality of life, and NYHA functional classification without an accompanying increase in peak VO2.
The combination study builds on previous clinical studies of both AE37 and Keytruda, AE37, a cancer vaccine, was the subject of a 300 patient prospective, randomized and single-blinded
Phase II study in patients with breast cancer.