Search results for "Adverse effect"
showing 10 items of 1065 documents
Gynecological adverse effects of natalizumab administration: Case report and review of the literature.
2018
Abstract Background Natalizumab is administered for the treatment of relapsing-remitting multiple sclerosis (RR-MS) with high disease activity.Natalizumab therapy has been associated with adverse effects, such as progressive multifocal leukoencephalopathy, liver damage, nasopharyngitis, urinary tract infection, urticaria, cephalgia, dizziness, fatigue, nausea, fever, rigidity, anxiety and gastroenteritis. Objective To describe a case of a woman with RR-MS who developed recurrent vaginitis on natalizumab administration. Methods Case report and review of the literature. Results The case of a 26-year-old Caucasian woman with RR-MS, who presented with recurrent vaginitis since the initiation of…
High cotinine levels are persistent during the first days of life in newborn second hand smokers.
2013
a b s t r a c t Background: Despite the adverse effects of maternal smoking during pregnancy on the newborn's health are well-known, in the pediatric population, a high prevalence exists that is very much affected by second hand smoke (SHS). This study aims to investigate the impact of maternal smoking habits during preg- nancy on cotinine levels in newborns during the first days of life. The high association between cotinine concentration in maternal and umbilical cord blood (UCB) has been previously reported, but the levels of blood cotinine that remain in infants born to smokers is unknown. Methods: Cotinine concentration was measured in UCB, in maternal and newborn peripheral blood. Dat…
Analysis of Safety and Tolerability Data Obtained from Over 1,500 Patients Receiving Topiramate for Migraine Prevention in Controlled Trials
2008
Objective. Topiramate is an effective and generally well-tolerated migraine preventive therapy, as shown in three large, randomized, double-blind, placebo-controlled registration trials. Based upon efficacy/tolerability, topiramate 100 mg/day (50 mg BID) is the recommended target dose for most patients with migraine. To further assess the safety and tolerability of topiramate for migraine prevention, we analyzed safety data from 1,580 patients who participated in the three pivotal registration trials or an earlier pilot, randomized, double-blind, placebo-controlled trial. Methods. The safety population consisted of all patients who took ≥1 dose of study medication during the double-blind …
A first-in-human study of PDC31 (prostaglandin F2 receptor inhibitor) in primary dysmenorrhea
2014
What is the safe and pharmacodynamically active dose range for PDC31 (prostaglandin F2α receptor inhibitor) in patients with primary dysmenorrhea (PD)?The 1 mg/kg/h dose of PDC31 appears to be safe and potentially effective in reducing intrauterine pressure (IUP) and pain associated with excessive uterine contractility when given as a 3-h infusion in patients with PD.PDC31 has previously been shown to reduce the duration and strength of PGF2α-induced contractions in human uterine myometrial strip models and to delay delivery in animal models of preterm labor.This was a prospective, multi-center, dose-escalating first-in-human Phase I study conducted from March 2011 to June 2012. A total of …
High-dose recombinant LH add-back strategy using high-dose GnRH antagonist is an innovative protocol compared with standard GnRH antagonist.
2011
High daily doses of gonadotrophin-releasing hormone (GnRH) antagonists during the follicular phase of ovarian stimulation were associated with low implantation rates. To test if this occurred because of profound pituitary suppression, the pituitary response was suppressed with a high-dose GnRH antagonist and recombinant LH (rLH) was added back to correct the implantation rate. An open-label, randomized, controlled, prospective clinical study in 60 patients undergoing IVF was performed. GnRH antagonist was initiated on day 6 of stimulation (2 mg/day) together with 375 IU rLH, and maintained until the day of HCG administration. Controls received 0.25 mg/day GnRH antagonist. Fluctuating LH con…
Neonatal outcome following long-distance air travel for fetoscopic laser coagulation treatment of twin-to-twin transfusion syndrome
2011
Abstract Objective To investigate the impact of undertaking long-distance air travel to a specialized medical center while pregnant in order to undergo fetoscopic laser coagulation (FLC) for twin-to-twin transfusion syndrome (TTTS). Methods A retrospective cohort study was conducted of women with TTTS who travelled by air (n = 16) or land (n = 61) to the Centre of Perinatal Diagnosis and Microinvasive Fetal Surgery, Mainz, Germany, between January 1, 2006, and December 31, 2010. All women underwent FLC on arrival at the study center. Neonatal outcome, postoperative neonatal survival rates, and rates of adverse effects were recorded. Results The postoperative survival rate for a single twin …
Effects of anemia correction with epoetin beta in patients receiving radiochemotherapy for advanced cervical cancer
2007
Patients with cervical cancer frequently suffer from anemia. This two-stage, adaptive-design study investigated the effect of anemia correction with epoetin beta on treatment outcomes. Patients with stage IIB–IVA cervical cancer received radiochemotherapy (RCT) and were randomized to epoetin 150 IU/kg three times weekly (n = 34) or standard care (control; n = 40) for up to 12 weeks. Primary end point for stage 1 aimed to establish a correlation between anemia correction and treatment failure (no complete response or relapsing within 6 months after RCT initiation) as a proof of concept before moving into stage 2. Secondary end points included progression/relapse-free survival, overall surviv…
How to assess the risks associated with the usage of a medical device based on predictive modeling: the case of an anemia control model certified as …
2021
Background The successful application of Machine Learning (ML) to many clinical problems can lead to its implementation as medical devices (MD), being important to assess the associated risks. Methods An anemia control model (ACM), certified as MD may face adverse events as the result of wrong predictions that are translated into suggestions of doses of erythropoietic stimulating agents to dialysis patients. Risks are assessed as the combination of severity and probability of a given hazard. While severities are typically assessed by clinicians, probabilities are tightly related to the performance of the predictive model. Results A post-marketing dataset formed by all adult patients registe…
Influence of aquatic training on the motor performance of patients with haemophilic arthropathy
2009
Thirteen patients with haemophilia A took part in this study voluntarily. They underwent an aquatic training programme over a 9-week period (27 sessions; three sessions per week; 1 h per session). Their motor performance was assessed by the following cardio-respiratory and mechanical variables before and after the training programme: oxygen uptake (VO(2), mL min(-1)), relative oxygen uptake (rel VO(2), mL min(-1).kg(-1)), carbon dioxide (CO(2), mL min(-1)), respiratory quotient (R), heart rate (bpm) and the distance covered in 12 min (the Cooper test, m). Nine patients successfully completed the intervention and measurement protocols without bleeding or other adverse events. After the propo…
A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II)
2020
Precis In this European study (STAR-II), MINIject, a novel, ab-interno, supraciliary MIGS device, effectively lowered intraocular pressure (IOP) and the need for IOP-lowering medications in patients with primary open-angle glaucoma. Purpose To evaluate the safety and performance of a minimally invasive supraciliary glaucoma drainage device (MINIject DO627, iSTAR Medical SA, Wavre, Belgium) for surgical treatment of primary open angle glaucoma in patients refractory to topical hypotensive medications. Methods In a prospective, interventional, single-arm, multi-center, European study (STAR-II), MINIject was successfully implanted in a standalone procedure in 29 of 31 patients in 8 sites in 3 …