Compassionate Use of Bacteriophage Therapy for Foot Ulcer Treatment as an Effective Step for Moving Toward Clinical Trials.
Sign Up to like & getrecommendations! Published in 2018 at "Methods in molecular biology"
DOI: 10.1007/978-1-4939-7395-8_14
Abstract: We here present detailed descriptions of successful treatment of a series of diabetic toe ulcers using the Eliava BioPreparations' commercial preparation of the very well-studied anti-staphylococcal bacteriophage Sb-1. This chapter outlines what we feel is… read more here.
Keywords: compassionate use; treatment; bacteriophage; clinical trials ... See more keywords
Early experience with compassionate use of 2 hydroxypropyl-beta-cyclodextrin for Niemann–Pick type C disease: review of initial published cases
Sign Up to like & getrecommendations! Published in 2017 at "Neurological Sciences"
DOI: 10.1007/s10072-017-2833-9
Abstract: Niemann–Pick type C (NP-C) is a rare neurodegenerative disorder. Management is mainly supportive and symptomatic. The investigational use of 2-hydroxypropyl-β-cyclodextrin (HP-β-CD) showed a promising role in treating NP-C, although efficacy and safety have not been… read more here.
Keywords: use hydroxypropyl; use; compassionate use; pick type ... See more keywords
Reversal of SARS-CoV2-Induced Hypoxia by Nebulized Sodium Ibuprofenate in a Compassionate Use Program
Sign Up to like & getrecommendations! Published in 2021 at "Infectious Diseases and Therapy"
DOI: 10.1007/s40121-021-00527-2
Abstract: Sodium ibuprofenate in hypertonic saline (NaIHS) administered directly to the lungs by nebulization and inhalation has antibacterial and anti-inflammatory effects, with the potential to deliver these benefits to hypoxic patients. We describe a compassionate use… read more here.
Keywords: compassionate use; group; use program; baseline ... See more keywords
Insights from compassionate use of tocilizumab for COVID‐19 to inform appropriate design of randomised controlled trials
Sign Up to like & getrecommendations! Published in 2020 at "British Journal of Clinical Pharmacology"
DOI: 10.1111/bcp.14466
Abstract: A proportion of patients with progressive COVID-19 display a cytokine release syndrome (CRS)-like pattern of hyperinflammation and immune dysregulation in association with respiratory failure. CRS is a form of systemic inflammatory response syndrome characterised by… read more here.
Keywords: compassionate use; treatment; covid; tocilizumab ... See more keywords
Fair, just and compassionate: A pilot for making allocation decisions for patients requesting experimental drugs outside of clinical trials
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Medical Ethics"
DOI: 10.1136/medethics-2016-103917
Abstract: Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so… read more here.
Keywords: use; compassionate use; clinical trials; patients requesting ... See more keywords
M12 52 month follow up of patients with IPF receiving nintedanib via the compassionate use programme
Sign Up to like & getrecommendations! Published in 2019 at "Thorax"
DOI: 10.1136/thorax-2019-btsabstracts2019.420
Abstract: Introduction In 2015 nintedanib became available on a compassionate use programme (CUP) to patients with idiopathic pulmonary fibrosis (IPF), after the 2014 publication of the INPULSIS trial1 and before receiving National Institute for Health and… read more here.
Keywords: compassionate use; number; fvc; baseline ... See more keywords
Acute subjective effects in LSD- and MDMA-assisted psychotherapy
Sign Up to like & getrecommendations! Published in 2021 at "Journal of Psychopharmacology"
DOI: 10.1177/0269881120959604
Abstract: Background: Lysergic acid diethylamide (LSD) and 3,4-methylenedioxymethamphetamine (MDMA) were used in psychotherapy in the 1960s–1980s, and are currently being re-investigated as treatments for several psychiatric disorders. In Switzerland, limited medical use of these substances is… read more here.
Keywords: lsd mdma; acute subjective; compassionate use; assisted psychotherapy ... See more keywords
The economic impact of compassionate use of medicines
Sign Up to like & getrecommendations! Published in 2021 at "BMC Health Services Research"
DOI: 10.1186/s12913-021-07255-w
Abstract: Compassionate use programs (CUP) for medicines respond to the ethical imperative of providing access to medicines before marketing approval to patients not recruited in trials. The economic impact of clinical trials has previously been investigated.… read more here.
Keywords: soc; cup; compassionate use; economic impact ... See more keywords
The Compassionate Use Advisory Committee (CompAC) for development of pre-approval access to investigational drugs.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2017.35.15_suppl.e18001
Abstract: e18001Background: In May 2015, CompAC was formed at NYU to provide guidance fairly and transparently on allocating a limited supply of , Daratumumab, to patients outside of clinical trials. Janssen... read more here.
Keywords: advisory committee; compac; compassionate use; compac development ... See more keywords
Compassionate Use of Contezolid for the Treatment of Tuberculous Pleurisy in a Patient with a Leadless Pacemaker
Sign Up to like & getrecommendations! Published in 2022 at "Infection and Drug Resistance"
DOI: 10.2147/idr.s373082
Abstract: Abstract We report the case of an 87-year-old woman with tuberculous pleurisy. She developed adverse effects in the form of thrombocytopenia and gastrointestinal hemorrhage with isoniazid, and thrombocytopenia with linezolid. Her treatment was switched to… read more here.
Keywords: use contezolid; pleurisy; compassionate use; tuberculous pleurisy ... See more keywords
Ceritinib compassionate use for patients with crizotinib-refractory, anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer.
Sign Up to like & getrecommendations! Published in 2018 at "Future oncology"
DOI: 10.2217/fon-2017-0441
Abstract: AIM Ceritinib was evaluated within a compassionate use program of Italian patients. PATIENTS & METHODS 70 patients with anaplastic lymphoma kinase-positive crizotinib-refractory advanced non-small-cell lung cancer received ceritinib. RESULTS Overall response was 40.6%, median progression-free… read more here.
Keywords: lymphoma kinase; compassionate use; anaplastic lymphoma; ceritinib ... See more keywords