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  • Intervention
  • This Funding Opportunity Announcement (FOA) issued by the National Heart, Lung, and Blood Institute, National Institutes of Health, solicits grant applications from institutions/organizations to conduct proof-of- concept Phase II clinical trials that test a novel intervention for a lung disease or a cardiopulmonary disorder from sleep that has the potential to significantly change clinical management. (nih.gov)
  • Although definitive Phase III trials will not be supported, the proposed studies must provide proof of concept for a novel intervention that has high potential for modifying current treatments and could be disease modifying. (nih.gov)
  • karnofsky
  • We created a computer software system to collect 13 patient-reported symptomatic adverse events and patient-reported Karnofsky performance status, semi-automated RECIST measurements, and laboratory data, and we made this information available to investigators in real time at the point of care during a phase II lung cancer trial. (mskcc.org)
  • study is being con
  • The Phase 2 T-Rex study is being conducted with support from Sanford Research, a Sanford Health subsidiary, a grant from the National Institute of Health and a grant from the California Institute for Regenerative Medicine. (bioportfolio.com)
  • endpoints
  • The key endpoints for the trial are the standard medical and regulatory endpoints for a T1D trial and include preservation of C-peptide (an accepted measure for pancreatic beta cell function), insulin use, severe hypoglycemic episodes and glucose and hemoglobin A1c levels. (bioportfolio.com)
  • therapies
  • Thermal ablative therapies used in clinical practice to date include Radiofrequency Ablation (RFA), Microwave Ablation (MWA) and Cryoablation This article will focus on the advantages and limitations of thermal ablative therapy and investigates the potential of a relatively new treatment modality, Electrochemotherapy (ECT), as a novel treatment for lung cancer. (mendeley.com)
  • A recent clinical trial has demonstrated a high response rate to stilboestrol given after a median of four previous oestrogen depriving endocrine therapies. (openrepository.com)
  • survival
  • Two trials of anastrozole compared with tamoxifen and one trial of letrozole compared with tamoxifen indicate that the new triazole aromatase inhibitors have a significant advantage over the anti-oestrogen with respect to time to progression and survival. (openrepository.com)
  • facilitates
  • This approach facilitates reporting of information closer to the time of events, and improves efficiency, and the ability to make earlier clinical decisions. (mskcc.org)
  • subjects
  • Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin┬« patch containing 250 ╬╝g peanut protein for a total active treatment period of 30 months (130 weeks). (clinicaltrials.gov)
  • consecutive
  • or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) must have negative pregnancy test. (clinicaltrials.gov)
  • intravenous
  • Historically physicians administer the two active drugs comprising INT230-6 by intravenous (IV) infusion to achieve a systemic blood level at the limit of tolerability. (clinicaltrials.gov)
  • data
  • Existing data management systems can be harnessed to enable real-time collection and review of clinical information during trials. (mskcc.org)
  • These data were published in Clinical Immunology and supportive two-year follow-up data from this study were published in the Journal of Translational Medicine ," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius Biosciences. (bioportfolio.com)
  • outcome
  • A phase 2 study of CLBS12 as a treatment for critical limb ischemia recently was initiated in Japan, a successful outcome of which will qualify the program for consideration of early conditional approval based on discussions with the Japanese regulatory authorities as provided for under Japan's progressive regenerative medicine regulations. (bioportfolio.com)
  • RECIST
  • Semi-automated RECIST measurements were available to clinicians online within a median of 2 days from the time of imaging. (mskcc.org)
  • therapy
  • The Company is investigating its lead product candidate, CLBS03, an ex vivo expanded polyclonal T regulatory cell therapy for the treatment of recent-onset type 1 diabetes, in an ongoing Phase 2 trial. (bioportfolio.com)
  • years
  • A similar trial of exemestane given after 2-3 years of tamoxifen compared with 5 years of tamoxifen is recruiting well as is a study comparing letrozole (or placebo) for 5 years after 5 years of adjuvant tamoxifen. (openrepository.com)
  • Without successful treatment, children remain immunodeficient and usually die by age 2 years. (clinicaltrials.gov)
  • Approximately 200 HIV-uninfected young men who have sex with men (YMSM) at high risk of acquiring HIV infection, ages 18-22 years, inclusive, will be recruited across all participating Adolescent Medicine Trials Units (AMTU). (clinicaltrials.gov)
  • research
  • In addition, each application must include at least one basic research ancillary study tightly related to the clinical question. (nih.gov)
  • This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such Adolescent Trials Network (ATN) research activities. (clinicaltrials.gov)