scholarly journals Efficacy of ultra‐micronized palmitoylethanolamide in canine atopic dermatitis: an open‐label multi‐centre study

2015 ◽  
Vol 26 (6) ◽  
pp. 432 ◽  
Author(s):  
Chiara Noli ◽  
M. Federica della Valle ◽  
Alda Miolo ◽  
Cristina Medori ◽  
Carlo Schievano ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Open Label ◽  
Multi Centre Study ◽  
Canine Atopic Dermatitis ◽  
Centre Study

scholarly journals P015: A phase IV protocol for a real world study on the use of low dose methoxyflurane (PENTHROX™) for the treatment of moderate to severe trauma pain in the Canadian emergency department (ADVANCE-ED)

CJEM ◽  
2019 ◽  
Vol 21 (S1) ◽  
pp. S68
Author(s):  
S. Campbell ◽  
L. Belle Blagrove ◽  
P. Piraino ◽  
S. Dhani
Keyword(s):  
Acute Pain ◽  
Real World ◽  
Emergency Departments ◽  
Rescue Medication ◽  
Low Dose ◽  
Adult Patients ◽  
Open Label ◽  
Multi Centre Study ◽  
Centre Study ◽  
Phase Iv

Introduction: Pain is a significant driver of demand in emergency care and 65% of adult patients with trauma also report moderate to severe pain. Inhaled low dose methoxyflurane (MEOF) a rapid-acting patient administered inhalational analgesic was recently approved in Canada for the short-term relief of moderate to severe acute pain associated with trauma or interventional medical procedures in conscious adult patients. This study will generate real-world evidence to complement the global clinical development program through evaluation of the effectiveness of MEOF in Canadian emergency departments. Methods: This is a phase IV, prospective open label, multi-centre study. Approximately 100 adult (≥18 yrs) patients with moderate to severe acute pain (NRS0-10≥4) associated with single system trauma will be enrolled at 5-10 EDs across Canada. Patients will receive a single treatment of up to 2 x 3 mL MEOF (2nd 3 mL to be provided only upon request), self-administered by the patient under medical supervision. Rescue medication will be permitted at any time, if required. Results: Planned Assessments and Outcome Measures: Pain will be assessed using the NRS0-10 at 4 time points: screening/triage, 5 minutes and 20 minutes post-start of administration (STA) of MEOF, and when ready for discharge. Secondary assessments will include the speed of action of analgesia (from STA of MEOF); patient and physician satisfaction with treatment (as assessed through Global Medical Performance (GMP) at 20 minutes post-STA and when ready for discharge); patient and physician fulfilment of pain relief expectations (assessed when ready for discharge); use of rescue medication and treatment-emergent adverse events. Exploratory outcomes will include the time to disposition, time to readiness for discharge and responder analysis. The primary outcome measure will be the change in pain intensity over 20 minutes from the start of administration of MEOF as measured on the NRS0-10. Conclusion: We report on the methodology of a phase IV, prospective open label, multi-centre study, evaluating the use of MEOF for the management of acute traumatic pain in Canadian Emergency Departments.

Phase II open-label, multi-centre study of bemcentinib (BGB324), a first-in-class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 3078-3078
Author(s):  
James Lorens ◽  
Carlos Eduardo Arce-Lara ◽  
Edurne Arriola ◽  
Paal Brunsvig ◽  
Enric Carcereny Costa ◽  
...  
Keyword(s):  
Phase Ii ◽  
Advanced Nsclc ◽  
Open Label ◽  
Multi Centre Study ◽  
Centre Study

Tick-borne encephalitis (TBE) vaccine to medically immunosuppressed patients with rheumatoid arthritis: A prospective, open-label, multi-centre study

Vaccine ◽  
2016 ◽  
Vol 34 (5) ◽  
pp. 650-655 ◽  
Author(s):  
Katarina Brodin Hertzell ◽  
Karlis Pauksens ◽  
Lars Rombo ◽  
Ann Knight ◽  
Sirkka Vene ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Open Label ◽  
Multi Centre Study ◽  
Centre Study ◽  
Tick Borne Encephalitis ◽  
Immunosuppressed Patients

scholarly journals Hepatitis A vaccine for immunosuppressed patients with rheumatoid arthritis: A prospective, open-label, multi-centre study

2014 ◽  
Vol 12 (2) ◽  
pp. 134-142 ◽  
Author(s):  
Helena H. Askling ◽  
Lars Rombo ◽  
Ronald van Vollenhoven ◽  
Ingemar Hallén ◽  
Åke Thörner ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Hepatitis A ◽  
Open Label ◽  
Multi Centre Study ◽  
Centre Study ◽  
Immunosuppressed Patients
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