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A Study To Compare The Efficacy And Safety Of 2 Dosing Regimens Of IV Infusions Of AZD9773 (CytoFab™) With Placebo In Adult Patients With Severe Sepsis And/or Septic Shock PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest A Study To Compare The Efficacy And Safety Of 2 Dosing Regimens Of IV Infusions Of AZD9773 (CytoFab™) With Placebo In Adult Patients With Severe Sepsis And/or Septic Shock articles that have been published worldwide.
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In this first study of generic dolutegravir (DTG)-containing regimens in a low-resource setting we assessed safety, tolerability and efficacy within a prospective cohort of 564 patients with at least 6 months of clinical follow-up. We provide support for a large-scale transition to DTG as part of first-line regimens.
The past several decades have seen significant policy efforts to improve the quality of care in nursing homes, but the patient safety movement has largely ignored this setting. In this study we compared nursing homes' performance on several composite quality measures from Nursing Home Compare, the most prominent recent example of a national policy aimed at improving the quality of nursing home care, to their performance on measures of patient safety in nursing homes such as pressure sores, infections, falls...
The intravenous (IV) formulation of fosfomycin has been re-introduced lately in clinical practice mainly to overcome treatment failures against multi drug-resistant (MDR), bacterial strains. However, appropriate dosing schedules of the IV formulation of the drug have not yet been established. Areas covered: The mechanism of action and resistance development, commercial IV formulations, pharmacokinetic/pharmacodynamics (PK/PD) properties, IV dosing regimens commonly used for the treatment of MDR infections a...
Topical immune-response modifiers are established for actinic keratosis (AK) treatment, and efforts are underway to further improve their efficacy and safety. We investigated the optimal dosing regimens of the TLR7/8 agonist resiquimod in terms of efficacy, safety, and tolerability. In a multi-centre, partly placebo-controlled (double-blind), clinical trial, we randomized 217 patients with AK-lesions to 0.03% resiquimod gel once daily application 3 times weekly for 4 weeks or 7 times within 2 weeks or 5 tim...
To determine the efficacy and safety of current maintenance therapies consisting of different regimens of long-acting β2-agonists (LABA) with inhaled corticosteroids (ICS) in patients with asthma.
To evaluate the efficacy and safety of 2 dosing regimens of ranibizumab 0.5 mg versus verteporfin photodynamic therapy in Asian patients with visual impairment due to myopic choroidal neovascularization.
The clinical utility of genotype-guided warfarin dosing remains controversial. The objective of this trial was to evaluate the efficacy and safety of genotype-guided warfarin dosing in East Asians.
S-1-based regimens have been shown to be as effective as other fluoropyrimidine-based regimens with a better safety profile in patients with advanced esophagogastric adenocarcinoma. However, real-world data on S-1 in European patients with advanced esophagogastric adenocarcinoma are lacking. The Safety Compliance Observatory on Oral fluoroPyrimidines (SCOOP) study evaluated safety and relative dose intensities for patients treated with S-1-based regimens for advanced esophagogastric adenocarcinoma as part o...
No dosing regimen has been established for the initial treatment of pediatric status epilepticus with intravenous midazolam. We therefore evaluated the efficacy, safety, and pharmacokinetics of bolus and continuous midazolam infusion.
The experience with the use of monoclonal antibodies and Fc-fusion proteins (mAb/Fc) in the pediatric population is limited. The objective of this study is to review those factors impacting the clinical efficacy and product safety of mAb/Fc products in pediatric patients during drug development. We reviewed the list of biologic products in the US Food and Drug Administration's Purple Book as of March 2018 with a focus on mAb/Fc products that are indicated for use in both adults and pediatric patients. Of 68...
One of the reasons for the failure of infliximab (IFX) is immediate hypersensitivity reactions (IHR). We aimed to report the efficacy and safety of a tolerance induction protocol in inflammatory bowel diseases (IBD) patients who had previously experienced IHR during IFX infusions.
In 2010, WHO recommended the use of new short-course treatment regimens in kala-azar elimination efforts for the Indian subcontinent. Although phase 3 studies have shown excellent results, there remains a lack of evidence on a wider treatment population and the safety and effectiveness of these regimens under field conditions.
Amikacin has been used for over 40 years in multidrug resistant tuberculosis (MDR-TB), but there is still debate on the right dose. The aim of this review was to search relevant pharmacokinetic (PK) and pharmacodynamic (PD) literature for the optimal dose and dosing frequency of amikacin in MDR-TB regimens trying to optimize efficacy while minimizing toxicity.
Efficacy and safety of a triple active sore throat lozenge in the treatment of patients with acute pharyngitis: Results of a multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial (DoriPha).
The aim of this multi-centre, randomised, double-blind, placebo-controlled trial was to compare the efficacy and safety of the fixed combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine (study drug marketed as Dorithricin ) in repeat dosing for 3 days to match placebo lozenges in the treatment of acute pharyngitis in adults.
Clinical trials of dupilumab have shown efficacy in treating moderate-to-severe atopic dermatitis (AD) in adult patients. While a phase 2 trial of dupilumab has shown efficacy and safety in children, the medication awaits Food and Drug Administration (FDA) approval, and off-label use is limited by dosing currently available to adults. We present this case series to describe the efficacy and safety profile of off-label dupilumab use in six pediatric patients treated by one provider in a private practice.
Once-daily lenvatinib 24 mg is the approved dose for radioiodine-refractory differentiated thyroid cancer. In a phase 3 trial with lenvatinib, the starting dose of 24 mg was associated with a relatively high incidence of adverse events that required dose reductions. We used an exposure-response model to investigate the risk-benefit of different dosing regimens for lenvatinib.
A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle-Controlled Clinical Study to Compare the Safety and Efficacy of a Halobetasol Propionate 0.01% lotion and Halobetasol Propionate 0.05% cream in the Treatment of Plaque Psoriasis.
Halobetasol propionate (HP) 0.05% is a highly effective short-term treatment for plaque psoriasis.
Two-drug regimens are increasingly used in clinical practice as switch strategies. We compared the efficacy and safety of two dolutegravir-based dual therapies (DT): dolutegravir plus lamivudine (3TC group) versus DTG plus rilpivirine (RPV group).
The optimal pharmacodynamic parameter for prediction of efficacy of vancomycin is the area under the concentration-time curve (AUC), and current published data indicate that dosing based on vancomycin trough concentrations is an inaccurate substitute. In this study, our objective was to compare the achievement of therapeutic target attainment after switching from a trough-based to an AUC-based dosing strategy as a part of our institution's vancomycin-per-pharmacy protocol.
A fixed-dose combination (FDC) of D-norpseudoephedrine, tri-iodothyronine, atropine, aloin, and diazepam is used in Mexico for the short-term treatment of obesity; however, its efficacy and safety have been scarcely studied. The aim of this study was to analyze the efficacy and safety of this FDC in Mexican adult overweight and obese patients by a prospective, uncontrolled, multicenter, phase IV open-label study.
Danvatirsen is a Generation 2.5 antisense oligonucleotide under clinical development. Population PK modelling was conducted using data from 3 available danvatirsen Phase I/II studies in oncology patients to investigate the impact of flat dosing on exposure compared to ideal body weight-based dosing. A total of 126 patients who received danvatirsen doses ranging from 1 to 4 mg/kg as monotherapy or in combination with durvalumab, most at 3 mg/kg (n = 70), was used in the danvatirsen population PK analysis...
The aim of the study was to assess safety and efficacy of apical support when using the soft-tissue metal fasteners of EndoFast Reliant™ SCP during laparoscopic sacrocolpopexy (LSCP).
Efficacy and safety profiles of alemtuzumab for relapsing-remitting multiple sclerosis (RRMS) mainly come from Western countries and have not been reported in Asian populations. The aim of this study was to report the efficacy and safety of alemtuzumab for RRMS patients in a Korean population.
To evaluate the efficacy and safety of oral weekly vinorelbine 60 mg/m for metastatic breast cancer (MBC) in patients previously treated with anthracyclines or taxanes in routine clinical practice.
Chronic hepatitis C virus (HCV) genotype (GT) 3 infection with advanced liver disease has emerged as a challenging to treat by direct-acting antivirals (DAAs), but the efficacy of DAAs in Chinese HCV-GT3 patients is rarely reported. This study aimed to analyze the efficacy of sofosbuvir (SOF)-based regimens in Chinese patients with HCV-GT3 and compensated liver disease.