A5084091819- Pain Mechanisms and Treatments
- Anesthesia and Pain Management
- Opioid Use Disorder Treatment
- Pharmacovigilance and Adverse Drug Reactions
- Pain Management and Opioid Use
- Herpesvirus Infections and Treatments
- Pharmaceutical Economics and Policy
- Drug-Induced Adverse Reactions
- Neuropeptides and Animal Physiology
- Pharmaceutical studies and practices
- Peripheral Neuropathies and Disorders
- Intramuscular injections and effects
- Dental Anxiety and Anesthesia Techniques
- Thermoregulation and physiological responses
- Pharmaceutical Quality and Counterfeiting
- Regulation of Appetite and Obesity
- Anesthesia and Sedative Agents
- Musculoskeletal pain and rehabilitation
- Analytical Methods in Pharmaceuticals
- Neonatal Respiratory Health Research
- Heart Rate Variability and Autonomic Control
- Healthcare Technology and Patient Monitoring
- Pediatric Pain Management Techniques
- Artificial Intelligence in Healthcare and Education
- Pain Management and Treatment
GlaxoSmithKline (Belgium)
2015-2024
Duke University
2024
Grünenthal Group (Germany)
2006-2009
Heinrich Heine University Düsseldorf
2001-2008
Düsseldorf University Hospital
2008
Johnson & Johnson (United States)
2008
Beaumont Hospital, Royal Oak
2008
Jewish General Hospital
2008
American Society of Anesthesiologists
2004
Die Johanniter
2001
BackgroundVaccination against respiratory syncytial virus (RSV) during pregnancy may protect infants from RSV disease. Efficacy and safety data on a candidate prefusion F protein–based maternal vaccine (RSVPreF3-Mat) are needed.MethodsWe conducted phase 3 trial involving pregnant women 18 to 49 years of age assess the efficacy RSVPreF3-Mat. The were randomly assigned in 2:1 ratio receive RSVPreF3-Mat or placebo between 24 weeks 0 days 34 gestation. primary outcomes any severe medically...
Objective: To evaluate the relative efficacy and tolerability of tapentadol immediate release (IR) oxycodone IR for management moderate to severe pain following orthopedic surgery (bunionectomy).Methods: Randomized patients (N = 901) received oral 50 or 75 mg, HCl 10 placebo every 4–6 h over a 72-h period surgery. Acetaminophen (≤2 g) was allowed in first 12 after dose study drug. In primary analysis, (50 mg) evaluated superior non-inferior mg (using sum intensity difference [SPID] 48 h),...
A phase III, double-blind, randomized, controlled trial (NCT00866619) in sub-Saharan Africa showed RTS,S/AS01 vaccine efficacy against malaria. We now present in-depth safety results from this study. 8922 children (enrolled at 5–17 months) and 6537 infants 6–12 weeks) were 1:1:1-randomized to receive 4 doses of (R3R) or non-malaria control (C3C), 3 plus (R3C). Aggregate data reviewed by a multi-functional team. Severe malaria with Blantyre Coma Score ≤2 (cerebral [CM]) gender-specific...
Tapentadol is a new, centrally acting analgesic with two mechanisms of action, combining μ-opioid agonism and norepinephrine reuptake inhibition in single molecule. This study assessed tapentadol immediate release (IR) patients postsurgical orthopedic pain.This randomized, double-blind, phase II involved moderate-to-severe pain after bunionectomy surgery (first metatarsal osteotomy). Patients (N = 269) were randomly assigned to receive IR 50 or 100 mg, oxycodone HCl 10 placebo; the drug was...
The adjuvanted recombinant zoster vaccine (RZV) received its first marketing authorization in October 2017, for prevention of herpes individuals aged ≥50 years. We summarized safety information, following RZV administration, by GSK via spontaneous adverse event (AE) reports submitted healthcare providers, recipients and other reporters. Observed-to-expected (O/E) analyses were performed selected outcomes: death, Guillain–Barré syndrome Bell's palsy. Standard case definitions used to assess...
Abstract Pharmacovigilance (PV) systems in many countries sub-Saharan Africa (SSA) are not fully functional. The spontaneous adverse events (AE) reporting rate SSA is lower than any other region of the world, and healthcare professionals (HCPs) have limited awareness AE surveillance procedures. GSK PV enhancement pilot initiative, collaboration with PATH national stakeholders, aimed to strengthen passive safety through a training mentoring program HCPs facilities three countries: Malawi,...
Complex regional pain syndrome (CRPS) is a chronic disorder that typically follows trauma or surgery. Suspected CRPS reported after vaccination with human papillomavirus (HPV) vaccines led to temporary suspension of proactive recommendation HPV in Japan. We investigated the potential signal relation HPV-16/18-adjuvanted vaccine (Cervarix®) by database review cases independent expert confirmation; disproportionality analysis and analyses temporality; an observed versus expected using...
Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan Africa. In Malawi, a PV enhancement initiative was introduced address major barriers PV. The objective of this improve reporting adverse events (AEs) by strengthening passive surveillance via training mentoring local stakeholders healthcare providers (HCPs) at their own facilities (HCFs). An 18-month programme implemented collaboration with national stakeholders, partnership the Ministry...
To assess pregnancy outcomes after exposure to AS04-HPV-16/18 vaccine (Cervarix, GSK, Belgium) prior to, or during pregnancy, as reported a registry. A registry was established collect data in the United Kingdom and States. Exposure defined vaccination with within 60 days before estimated conception date delivery. Reporting voluntary. Between September 2007 November 2015, 306 reports were received of which 181 prospective, evaluable reports. From these reports, 154 (85.1%) pregnancies...
Sympathetic modulation of cutaneous vasomotor waves in humans is most effective at frequencies up to 0.1 Hz. In contrast, sympathetic mesenteric rats strongest the frequency band between 0.2 and 0.75 Therefore, we addressed question as whether these different response characteristics are due species- or organ-specific disparities. Eleven Sprague-Dawley were instrumented with catheters carotid artery jugular vein, together electrodes on centrally sectioned left lumbar trunk (LST) laser...
Background The neuropeptide nocistatin (NST) has been implicated in the modulation of nociceptive responses spinal cord. Depending on dose, both pronociceptive and antinociceptive effects have repeatedly reported. effect is most likely attributable to inhibition synaptic glycine gamma-aminobutyric acid release a subsequent reduction activation inhibitory receptors, but mechanisms its action hitherto remained elusive. It recently demonstrated that synaptically released contributes...
We tested whether nociceptin (NCE), the endogenous ligand of opioid receptor‐like 1 (ORL1) receptor, and nocistatin (NST), which reverses central NCE effects when applied intrathecally (i.t.), affect small‐diameter afferent fibre‐mediated vasodilatation in rat hairless skin. Female Wistar rats were vagotomized. Ongoing sympathetic vasoconstrictor activity was abolished by bilateral section lumbar trunk between ganglia L2 L3. Sensory axons selectively stimulated dorsal root L5 20 electrical...
For over 50 years, spontaneous reporting systems (SRSs) were the only option for identifying unexpected effects of products once marketed.1 Their high sensitivity makes SRSs especially well-suited rare drug- or vaccine-related outcomes. However, signals adverse events (AEs) that occur frequently in untreated populations (i.e., those with background rates) might be harder to detect effectively.2 In addition, are not appropriate incidence estimation, and rates established, widely publicized...