The adverse effects of mefloquine in deployed military personnel

2014 ◽  
Vol 100 (3) ◽  
pp. 232-237
Author(s):  
S Adshead
Keyword(s):  
Adverse Events ◽  
Military Personnel ◽  
Adverse Reactions ◽  
Primary Study ◽  
Study Objective ◽  
Stressful Environment ◽  
Clinically Significant ◽  
Primary Study Objective ◽  
Subsequent Patient

AbstractIntroductionMefloquine (Lariam®) is an effective anti-malarial prescribed to over 35 million travellers world-wide as chemoprophylaxis. However, it has been the subject of increased scrutiny and media attention due to its association with significant neuropsychiatric adverse events. Anecdotal evidence suggests that patient trust in the drug is waning.MethodsA prospective questionnaire-based cohort study of 150 deployed military personnel prescribed mefloquine as anti-malaria chemoprophylaxis. The primary study objective was to assess the rate of adverse reactions. In addition, an audit of mefloquine prescriptions and subsequent patient follow-up was conducted.ResultsAmong a cohort of 111 individuals taking mefloquine, 54% reported at least one adverse effect and 13% required a change in prescription to a second-line anti-malarial, due to significant side-effects. All females prescribed mefloquine reported at least one adverse reaction. There were two cases of clinically significant adverse reactions.ConclusionsThere was a higher rate of adverse events reported amongst deployed military personnel than has been reported among civilian patients. This may be partly due to the stressful environment in which deployed personnel operate.

scholarly journals Comparison of Short- versus Long-Course Antimicrobial Therapy of Uncomplicated Bacterial Pneumonia in Dogs: A Double-Blinded, Placebo-Controlled Pilot Study

Animals ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. 3096
Author(s):  
Aida I. Vientós-Plotts ◽  
Isabelle Masseau ◽  
Carol R. Reinero
Keyword(s):  
Pilot Study ◽  
Antimicrobial Therapy ◽  
Bacterial Pneumonia ◽  
Clinical Signs ◽  
Current Treatment ◽  
Controlled Study ◽  
Primary Study ◽  
Study Objective ◽  
Primary Study Objective ◽  
Double Blinded

Current treatment for canine bacterial pneumonia relies on protracted courses of antimicrobials (3–6 weeks or more) with recommendations to continue for 1–2 weeks past resolution of all clinical and thoracic radiographic abnormalities. However, in humans, bacterial pneumonia is often treated with 5–10-day courses of antimicrobials, and thoracic radiographs are not considered useful to guide therapeutic duration. The primary study objective was to determine whether a short course of antimicrobials would be sufficient to treat canine bacterial pneumonia. Eight dogs with uncomplicated bacterial pneumonia were enrolled in this randomized, double-blinded, placebo-controlled study comparing clinical and radiographic resolution with differing durations of antimicrobial therapy. Dogs received a course of antimicrobials lasting 10 (A10) or 21 (A21) days. Dogs randomized to the A10 group received placebo for 11 days following antimicrobial therapy. Patients were evaluated at presentation and 10, 30 and 60 days after the initiation of antimicrobials. At 10 days, 6/8 dogs had resolution of both clinical signs and inflammatory leukogram, and 5/8 dogs had improved global radiographic scores. After 60 days, clinical and hematologic resolution of pneumonia was noted in all dogs regardless of antimicrobial therapy duration; however, 3/8 dogs had persistent radiographic lesions. Thoracic radiographs do not appear to be a reliable marker to guide antimicrobial therapy in canine bacterial pneumonia as radiographic lesions may lag or persist despite clinical cure. This pilot study suggests a 10-day course of antimicrobials may be sufficient to treat uncomplicated canine bacterial pneumonia.

Evaluation of 3-day azithromycin or 5-day cefaclor in comparison with 10-day amoxicillin for treatment of tonsillitis in children

2019 ◽  
Vol 97 (10) ◽  
pp. 939-944
Author(s):  
Peng Li ◽  
Genqin Jiang ◽  
Xiaofei Shen
Keyword(s):  
Adverse Events ◽  
Adverse Reactions ◽  
Clinical Success ◽  
Statistical Significance ◽  
Occurrence Rate ◽  
Hemolytic Streptococcus ◽  
Efficacy Analysis ◽  
Bacteriological Eradication ◽  
Group A

To evaluate the clinical efficacy of azithromycin, cefaclor, and amoxicillin in treatment of pediatric tonsillitis, a total of 256 children with Group A β-hemolytic streptococcus (GAS) tonsillitis were randomly divided into 3 groups. Only patients assessed with streptococcus-positive tonsillitis, considered to be compliant with treatment and complete clinical and microbiological evaluations at the end of therapy (day 14) and follow-up (day 30) were included in the efficacy analysis. Our study demonstrated that 96.4% of patients in the azithromycin group, 92.4% of patients in the cefaclor group, and 91.0% of patients in the amoxicillin group were recorded as clinical success at the end of therapy. Bacteriological eradication rates of the 3 groups at the end of therapy were 94.0%, 89.9%, and 88.5%, respectively. A pathogen recurrence rate was evaluated as 2.6%, 7.0%, and 5.9% at the follow-up. Treatment-stimulated adverse events occurred in 2.4% of patients in the azithromycin group, 11.3% in the cefaclor group, and 11.4% in the amoxicillin group. In summary, azithromycin showed an effective tendency for the treatment of pediatric tonsillitis with lower occurrence rate of adverse reactions, although there is no statistical significance for the clinical and bacteriological eradication efficacy between these 3 groups.

Basin-to-prospect-scale subsurface characterisation: new insights into the Exmouth Sub-basin, North West Shelf, Australia

2021 ◽  
Vol 61 (2) ◽  
pp. 640
Author(s):  
Abdul Kholiq ◽  
Claire Jacob ◽  
Bee Jik Lim ◽  
Oliver Schenk ◽  
Anubrati Mukherjee ◽  
...  
Keyword(s):  
Oil And Gas ◽  
Upper Jurassic ◽  
Hydrocarbon Exploration ◽  
Primary Study ◽  
Rift System ◽  
Study Objective ◽  
North West ◽  
Northern Carnarvon Basin ◽  
Primary Study Objective ◽  
Hydrocarbon Charge

The Exmouth Sub-basin represents part of the intracratonic rift system of the northern Carnarvon Basin, Australia. Hydrocarbon exploration has resulted in the discovery of a variety of oil and gas accumulations, mainly in Upper Triassic, Upper Jurassic and Lower Cretaceous intervals. Recent 3D petroleum systems modelling aided in understanding the interaction of the complex basin evolution and hydrocarbon charge history, shedding light on the variety and distribution of hydrocarbon types encountered, whilst also highlighting future remaining potential in both proven and untested plays. As a result of this modelling, the Exmouth Subsurface Characterisation Study was commissioned to further leverage >12000km2of recently acquired and processed seismic data and integrate data from specifically conditioned wells from across the Exmouth Sub-basin. The primary study objective was to better understand the distribution of lithologies across the basin, with focus upon the reservoir presence and properties over proven and potential deeper sections. Furthermore, given the variety of hydrocarbon types encountered, this study set out to understand the amplitude behaviour of these types within the different reservoirs. Collectively, these results have aided in identifying analogous hydrocarbon amplitude responses across the basin, derisking identified plays, prospects and existing discoveries and fields whilst also identifying new plays and leads.

scholarly journals Changes in snow cover occurrence and the atmospheric circulation impact in Poznań (Poland)

2021 ◽  
Author(s):  
Katarzyna Szyga-Pluta
Keyword(s):  
Snow Cover ◽  
Atmospheric Circulation ◽  
Thermal Conditions ◽  
Severity Index ◽  
Primary Study ◽  
Winter Period ◽  
Study Objective ◽  
Primary Study Objective ◽  
The Impact ◽  
Winter Severity

AbstractThe variability of occurrence of snow cover and the impact of atmospheric circulation on the snow cover occurrence in the period 1966/1967–2019/2020 in Poznań (Poland) have been examined. The implementation of the primary study objective covers the comprehensive analysis of the winter snow and thermal conditions using various indicators. This paper is based on daily data from the years 1966–2020 concerning the winter period. Winters in Poznań are highly variable and differentiated, considering the duration of particular seasons, number of days with snow cover, mean snow cover thickness, winter snowiness coefficient, or winter severity index. Negative trends concerning days with snow cover total snow cover depth winter snowiness coefficient and winter severity index in Poznań prove statistically significant. A higher probability of occurrence of snow cover was determined during cyclonic than anticyclonic circulation. The westerly and northerly types especially favoured the occurrence of days with snow cover. The increase of snow cover was associated with the northerly inflow mainly. Westerly types of circulation caused the decrease of snow cover predominantly.

scholarly journals Gaboxadol in Fragile X Syndrome: A 12-Week Randomized, Double-Blind, Parallel-Group, Phase 2a Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Dejan B. Budimirovic ◽  
Kelli C. Dominick ◽  
Lidia V. Gabis ◽  
Maxwell Adams ◽  
Mathews Adera ◽  
...  
Keyword(s):  
Adverse Events ◽  
Fragile X Syndrome ◽  
Fragile X ◽  
Autism Spectrum ◽  
Tonic Inhibition ◽  
Controlled Study ◽  
Primary Study ◽  
Double Blind ◽  
Study Objective ◽  
Parallel Group

Background: Fragile X syndrome (FXS), the most common single-gene cause of intellectual disability and autism spectrum disorder (ASD), is caused by a >200-trinucleotide repeat expansion in the 5’ untranslated region of the fragile X mental retardation 1 (FMR1) gene. Individuals with FXS can present with a range of neurobehavioral impairments including, but not limited to: cognitive, language, and adaptive deficits; ASD; anxiety; social withdrawal and avoidance; and aggression. Decreased expression of the γ-aminobutyric acid type A (GABAA) receptor δ subunit and deficient GABAergic tonic inhibition could be associated with symptoms of FXS. Gaboxadol (OV101) is a δ-subunit–selective, extrasynaptic GABAA receptor agonist that enhances GABAergic tonic inhibition, providing the rationale for assessment of OV101 as a potential targeted treatment of FXS. No drug is approved in the United States for the treatment of FXS.Methods: This 12-weeks, randomized (1:1:1), double-blind, parallel-group, phase 2a study was designed to assess the safety, tolerability, efficacy, and optimal daily dose of OV101 5 mg [once (QD), twice (BID), or three-times daily (TID)] when administered for 12 weeks to adolescent and adult men with FXS. Safety was the primary study objective, with key assessments including treatment-emergent adverse events (TEAEs), treatment-related adverse events leading to study discontinuation, and serious adverse events (SAEs). The secondary study objective was to evaluate the effect of OV101 on a variety of problem behaviors.Results: A total of 23 participants with FXS (13 adolescents, 10 adults) with moderate-to-severe neurobehavioral phenotypes (Full Scale Intelligence Quotient, 41.5 ± 3.29; ASD, 82.6%) were randomized to OV101 5 mg QD (n = 8), 5 mg BID (n = 8), or 5 mg TID (n = 7) for 12 weeks. OV101 was well tolerated across all 3 treatment regimens. The most common TEAEs were upper respiratory tract infection (n = 4), headache (n = 3), diarrhea (n = 2), and irritability (n = 2). No SAEs were reported. Improvements from baseline to end-of-treatment were observed on several efficacy endpoints, and 60% of participants were identified as treatment responders based on Clinical Global Impressions-Improvement.Conclusions: Overall, OV101 was safe and well tolerated. Efficacy results demonstrate an initial signal for OV101 in individuals with FXS. These results need to be confirmed in a larger, randomized, placebo-controlled study with optimal outcomes and in the most appropriate age group.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03697161

scholarly journals Observation of the effect on immediate mandibular implant-supported overdenture of micro implant system of Italy

2020 ◽  
Vol 36 (6) ◽  
Author(s):  
Yin Xuemeng ◽  
Dai Shasha
Keyword(s):  
Adverse Events ◽  
Adverse Reactions ◽  
Clinical Effect ◽  
Alveolar Bone ◽  
Control Group ◽  
Observation Group ◽  
Curative Effect ◽  
Low Incidence ◽  
Implant System

The study was design to investigate the clinical effect of Micro implant system in Italy on immediate mandibular implant-supported overdenture. A total of 192 patients with mandibular edentulous treated in our hospital were randomly divided into 2 groups in which the control group consisted of 96 patients treated with immediate mandibular implant-supported overdenture by Xive implant system, while the observation group included 96 cases treated with the overdenture by Italy Micro implant system. Patients were followed up for 1 year and then the states of implant-borne overdentures, marginal bone resorption around alveolar bone, the compatibility of implant restorations with adjacent teeth, adverse events and satisfaction degree were compared between the groups. According to the results of 1-year follow-up, the resorption around alveolar bone of the observation group was significantly higher than that of the control group (p<0.05). In the observation group the differences in labial gingival margin position, gingival color and texture were significantly better (p<0.05) as compared to control group. The incidence of adverse events was notably lower (p<0.05). The Italy Micro implant system has significant curative effect on mandibular implant-supported overdentures with good compatibility of the implant restorations with adjacent teeth and low incidence rate of adverse reactions, so it is worthy of clinical application and spreading.

Overall survival (OS) in contemporary randomized clinical trials (RCT) in advanced breast cancer (ABC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 1002-1002
Author(s):  
A. Katz ◽  
E. D. Saad ◽  
M. E. Buyse
Keyword(s):  
Randomized Clinical Trials ◽  
Statistical Significance ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Primary Study ◽  
Medical Subject Headings ◽  
Study Objective ◽  
Phase Iii Trials ◽  
Primary Study Objective ◽  
The One

1002 Background: OS has been considered an elusive endpoint, while progression-free survival (PFS), time to tumor progression (TTP), and time to treatment failure (TTF) have been used frequently and often interchangeably as primary endpoints (PE) in ABC (Saad, Ann Oncol 2009). Methods: We searched PubMed using the medical subject headings “breast neoplasms” and “drug therapy,” limiting the search to phase III trials on systemic antineoplastic therapies published between 1/2000 and 12/2007 in 8 leading medical journals (Ann Oncol, BCRT, BJC, Cancer, EJC, JCO, Lancet Oncol, and NEJM). PE was the one stated explicitly, used for N calculation, or listed first. Significant PE (SigPE) was considered as P <0.05 for superiority trials (N=47), or proven non-inferiority/equivalence otherwise. Results: We retrieved 58 RTCs, with a median sample size of 329 evaluable patients. The table shows the breakdown of these trials by size and PE, and the number of trials that reached statistical significance on their PE and on OS. Overall, a statistically significant gain in OS was reported in 11 of 58 RCTs (19%). In 30 RCTs with gain in PE, 26 favored the experimental arm. Conclusions: While publication and journal selection biases may not be excluded, our review suggests that gain in OS, although seldom a primary study objective, is not infrequent in contemporary RCTs in ABC. However, the majority of RCTs are underpowered for OS, which remains a secondary or exploratory endpoint in most cases. [Table: see text] No significant financial relationships to disclose.

A phase I trial of a local delivery of siRNA against k-ras in combination with chemotherapy for locally advanced pancreatic adenocarcinoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 4037-4037 ◽  
Author(s):  
Talia Golan ◽  
Ayala Hubert ◽  
Amotz Shemi ◽  
Amiel Segal ◽  
Alan Dancour ◽  
...  
Keyword(s):  
Adverse Events ◽  
Phase I ◽  
Pancreatic Adenocarcinoma ◽  
Phase Ii ◽  
Locally Advanced ◽  
Primary Study ◽  
Open Label ◽  
Serious Adverse Events ◽  
Line Setting

4037 Background:K-Ras mutation G12D is most prevalent in pancreatic adenocarcinoma (PDAC). siRNA against the K-RasG12D(siG12D) mutant had showed significant preclinical anti-tumor effects. siG12D LODER - miniature biodegradable polymeric matrix that encompasses anti-K-RasG12D siRNA drug, is placed with Endoscopic US biopsy and designed to continuously release the drug regionally over a period of 4 months. Methods: Open label phase I study of patients with locally advanced non-operable PDAC in the first-line setting. Patients were assigned to receive siG12D LODERs in dose escalation cohorts: 0.025mg, 0.75mg and 3.0mg. Gemcitabine 1000 mg/m2IV was given weekly, following siG12D LODER insertion. The RP2D (recommended phase II dose) was further examined in 3.0 mg dose cohort in combination with modified Folfirinox (Oxaliplatin 85mg/m2, Irinotecan 150mg/m2, Fluorouracil infusion 2,400mg/m2 46 hours, every 2 weeks). Follow up period was 8 weeks and survival follow up until death. Primary study objectives were to determine the dose-limiting toxicities (DLT) and maximum tolerated doses (MTD). Results:15 patients have been enrolled. 2 patients were omitted from study due to metastatic disease detected on day 1 post siG12D LODER implant imaging . Median age = 70 (range 52-85); male:female 8:7. Among 13 treated patients, the most frequent adverse events observed in the study were typically grade 1- 2 in severity; 4 patients experienced serious adverse events (SAE), one procedure related. No DLTs were observed. MTD was not reached. CT performed 8-10 weeks following the procedure showed stable disease in all patients. Reduction in tumor marker CA 19-9 was observed in 64% (7/11) of patients. The median survival of 13 patients was 16 months ( 8/13 patients still alive at analysis). Conclusions: The combination of siG12D LODER and chemotherapy is well tolerated. The combination has demonstrated promising efficacy in locally advanced PDAC with durable responses. Phamocodynamic endpoints are currently being examined in an expansion cohort in operable patients. A phase II randomized trial is planned in order to investigate efficacy of siG12D LODER in locally advanced non-operable PDAC. Clinical trial information: NCT01188785.

Assessing analgesia equivalence and appetite following alfaxalone- or ketamine-based injectable anesthesia for feline castration as an example of enhanced recovery after surgery

2017 ◽  
Vol 20 (2) ◽  
pp. 73-82 ◽  
Author(s):  
Tatum Armstrong ◽  
Marika C Wagner ◽  
Jagjit Cheema ◽  
Daniel SJ Pang
Keyword(s):  
Enhanced Recovery ◽  
Statistical Significance ◽  
Pain Scale ◽  
Primary Study ◽  
Rescue Analgesia ◽  
Study Objective ◽  
Scale Scores ◽  
The Difference ◽  
Primary Study Objective ◽  
Species Specific

Objectives The primary study objective was to assess two injectable anesthetic protocols, given to facilitate castration surgery in cats, for equivalence in terms of postoperative analgesia. A secondary objective was to evaluate postoperative eating behavior. Methods Male cats presented to a local clinic were randomly assigned to receive either intramuscular ketamine (5 mg/kg, n = 26; KetHD) or alfaxalone (2 mg/kg, n = 24; AlfHD) in combination with dexmedetomidine (25 μg/kg) and hydromorphone (0.05 mg/kg). All cats received meloxicam (0.3 mg/kg SC) and intratesticular lidocaine (2 mg/kg). Species-specific pain and sedation scales were applied at baseline, 1, 2 and 4 h postoperatively. Time taken to achieve sternal recumbency and begin eating were also recorded postoperatively. Results Pain scale scores were low and showed equivalence between the treatment groups at all time points (1 h, P = 0.38, 95% confidence interval [CI] of the difference between group scores 0–0; 2 h, P = 0.71, 95% CI 0–0; 4 h, P = 0.97, 95% CI 0–0). Four cats crossed the threshold for rescue analgesia (KetHD, n = 1; AlfHD, n = 3). At 1 h, more cats in the KetHD (65%) group than in the AlfHD (42%) group were sedated, but statistical significance was not detected ( P = 0.15, 95% CI −1 to 0). Most AlfHD cats (88%) began eating by 1 h vs 65% of KetHD cats ( P = 0.039). Time to recover sternal recumbency did not differ between groups ( P = 0.86, 95% CI −14.1 to 11.8). Conclusions and relevance These results show that AlfHD and KetHD provide equivalent analgesia as part of a multimodal injectable anesthetic protocol. Alfaxalone is associated with an earlier return to eating.

“I Do Want to Stop, At Least I Think I Do”: An International Comparison of Recovery From Nonsuicidal Self-Injury Among Young People

2016 ◽  
Vol 33 (4) ◽  
pp. 416-441 ◽  
Author(s):  
Lauren Kelada ◽  
Penelope Hasking ◽  
Glenn Melvin ◽  
Janis Whitlock ◽  
Imke Baetens
Keyword(s):  
Young People ◽  
The United States ◽  
National Sample ◽  
Primary Study ◽  
Study Objective ◽  
Self Injury ◽  
Three Samples ◽  
Primary Study Objective ◽  
Cross National ◽  
Nonsuicidal Self Injury

Phenomenological and cultural understandings of recovery from the perspective of individuals who engage in nonsuicidal self-injury (NSSI) are rare. The primary study objective was to understand similarities across three samples in (a) how young people define recovery from NSSI and (b) what they consider helpful approaches taken by parents and professionals to assist their recovery. Using a cross-national sample of young people ( n = 98) from Australia ( n = 48), Belgium ( n = 25) and the United States ( n = 25), we assessed their perspectives on NSSI. Consistent across all samples, young people defined recovery as no longer having the urge to self-injure when distressed, often displayed ambivalence about recovery, and reported it was helpful when parents and professionals were calm and understanding. Acceptance of recovery as a process involving relapses may need to be emphasized in NSSI treatment, to ease the pressure young people often place on themselves to stop the behavior outright.

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