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.

Effect of Saccharomyces boulardii in dogs with chronic enteropathies: double-blinded, placebo-controlled study

2017 ◽  
Vol 182 (9) ◽  
pp. 258-258 ◽  
Author(s):  
Simona D’Angelo ◽  
Federico Fracassi ◽  
Francesca Bresciani ◽  
Roberta Galuppi ◽  
Alessia Diana ◽  
...  
Keyword(s):  
Body Condition Score ◽  
Activity Index ◽  
Clinical Signs ◽  
Saccharomyces Boulardii ◽  
Controlled Study ◽  
Clinical Activity ◽  
Short Term ◽  
Chronic Enteropathies ◽  
Healthy Dogs ◽  
Double Blinded

Saccharomyces boulardii is used to treat acute and chronic enteropathies in humans, but to date, no studies have evaluated the use of this yeast in dogs. The current study, a prospective non-randomised, double-blinded, placebo-controlled study, evaluated the effects of S boulardii in healthy dogs and dogs with chronic enteropathies (CE). Four healthy dogs and 20 dogs with CE were included. In healthy dogs, S boulardii was administered for 10 days. Possible short-term adverse effects were recorded, and quantitative stool cultures for yeasts were performed. In dogs with CE, S boulardii or a placebo was administered in addition to standard treatment protocols. Canine Chronic Enteropathy Clinical Activity Index, abdominal ultrasonography, gastroenteroscopy and histology were performed at the time of diagnosis and after 60 days of treatment. In healthy dogs, S boulardii reached a steady state in five days and was completely eliminated on day 4 after administration. No short-term side effects were seen. Clinical activity index, stool frequency, stool consistency and body condition score improved significantly in dogs with CE receiving S boulardii versus the placebo. In conclusion, S boulardii can be safely used in dogs with CE and seems to achieve better control of clinical signs than standard therapy alone.

A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (mBC) (HER2CLIMB).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS1107-TPS1107 ◽  
Author(s):  
Carey K. Anders ◽  
Rashmi Krishna Murthy ◽  
Erika Paige Hamilton ◽  
Virginia F. Borges ◽  
David A. Cameron ◽  
...  
Keyword(s):  
Single Agent ◽  
Locally Advanced ◽  
Data Monitoring Committee ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Controlled Study ◽  
Primary Study ◽  
Synergistic Activity ◽  
Study Objective ◽  
Metastatic Breast Carcinoma

TPS1107 Background: Tucatinib (ONT-380) is a highly selective small molecule inhibitor of HER2 kinase with nanomolar potency. Unlike dual HER2/EGFR agents, it does not inhibit EGFR at clinically relevant concentrations, decreasing the potential for EGFR-related toxicities (severe skin rash and diarrhea). In preclinical studies, tucatinib demonstrated synergistic activity with Tz, and was active in HER2+ models of brain metastases (mets). In a Phase 1b study, tucatinib was combined with C and Tz in pts with HER2+ MBC previously treated with trastuzumab emtansine (T-DM1) and Tz. Objective responses were seen, including in pts with brain mets. The combination was well tolerated, with low rates of Gr 3 diarrhea at the recommended dose (300 mg PO BID, equivalent to the single agent MTD). Based on these data, tucatinib is now being evaluated in a study in combination with C and Tz (HER2CLIMB). Methods: The primary study objective is to assess the effect of tucatinib vs. placebo given with C + Tz on progression-free survival (PFS) based on independent central review. Additional objectives include PFS in patients with brain mets, overall survival, ORR, duration of response, clinical benefit rate, and safety. The study population includes adult patients with progressive HER2+ locally advanced or MBC who have had prior treatment with a taxane, Tz, pertuzumab and T-DM1. Patients with brain mets, including untreated or progressive brain mets, may be enrolled. 480 patients will be enrolled in North America, Europe, Israel, and Australia. Patients are receiving C (1000 mg/mg2 PO BID for 14 days of a 21-day cycle) and Tz (6 mg/kg IV once every 21 days), and are being randomized in a 2:1 ratio to tucatinib 300 mg PO BID or placebo. Patients with isolated CNS progression may continue on study treatment after undergoing local CNS therapy. An independent Data Monitoring Committee is monitoring patient safety. Clinical trial information: NCT02614794.

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 Double‐blinded, randomized, and controlled study on the effects of canagliflozin after bariatric surgery: A pilot study

2020 ◽  
Vol 6 (3) ◽  
pp. 255-263
Author(s):  
Sangeeta R. Kashyap ◽  
Karim Kheniser ◽  
Ali Aminian ◽  
Philip Schauer ◽  
Carel Le Roux ◽  
...  
Keyword(s):  
Bariatric Surgery ◽  
Pilot Study ◽  
Controlled Study ◽  
Double Blinded

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

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.

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.

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.

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