Clinical evaluation of the effects of a single oral dose of gabapentin on fear-based aggressive behaviors in cats during veterinary examinations

2021 ◽  
pp. 1-7
Author(s):  
Marie Kruszka ◽  
Edith Graff ◽  
Tiphaine Medam ◽  
Sylvia Masson
Keyword(s):  
Adverse Effects ◽  
Oral Dose ◽  
Single Oral Dose ◽  
Untreated Control ◽  
Control Group ◽  
Aggressive Behaviors ◽  
Untreated Control Group ◽  
Control Groups ◽  
Complete Evaluation ◽  
Double Blind

Abstract OBJECTIVE To investigate the effects of a single oral dose of gabapentin on fear-based aggressive behaviors (FABs) in cats during veterinary examinations. ANIMALS 55 healthy pet cats (26 with and 29 without a history of FAB during veterinary visits [FAB and untreated control groups, respectively]). PROCEDURES A standardized 9-step clinical examination protocol (with patient compliance scored from 0 to 9 according to the highest completed step) was tested on untreated control group cats. The protocol was then used in a double-blind, randomized, placebo-controlled, crossover-design trial in which FAB-group cats received owner-administered gabapentin (100 or 200 mg/cat) or placebo capsules 2 hours before the first of 2 veterinary visits and received the alternate treatment before the second visit ≥ 1 day later. Ease of administration (scored from 1 [very difficult] to 4 [very easy]) and adverse effects were recorded. Compliance scores were compared between treatments for the FAB group and between FAB and untreated control groups. Changes in scores between treatments for the FAB group were used to investigate associations between selected variables and the outcome of interest. RESULTS FAB group compliance scores after gabapentin administration (median, 9; range, 0 to 9) were significantly higher than scores after placebo administration (median 0.5; range, 0 to 7) and did not differ from scores for the untreated control group. Owner scores indicated capsule administration was easy. Adverse effects (most commonly drowsiness, myorelaxation, and ataxia) resolved ≤ 10 hours after detection. CONCLUSIONS AND CLINICAL RELEVANCE Results suggested oral administration of gabapentin to cats 2 hours before a veterinary visit can reduce FAB during physical examination, enabling more complete evaluation.

Netupitant/palonosetron (NEPA) for prevention of delayed chemotherapy-induced nausea and vomiting (CINV) in multiple cycles of chemotherapy.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 211-211
Author(s):  
Lee Steven Schwartzberg ◽  
Richard J. Gralla ◽  
Kimia Kashef ◽  
Hope Rugo
Keyword(s):  
Oral Dose ◽  
Single Oral Dose ◽  
Complete Response ◽  
Control Group ◽  
Double Blind ◽  
Report Data ◽  
Multiple Cycles ◽  
To Receive ◽  
Delayed Phase ◽  
Significant Nausea

211 Background: Prevention of CINV in the delayed phase (24-120 h post-chemotherapy) and over multiple cycles of chemotherapy remains a challenge. NEPA, a fixed combination of the NK1 receptor antagonist (RA) netupitant (300 mg) and the 5-HT3 RA palonosetron (PALO; 0.5 mg), has demonstrated efficacy in multiple studies, in both acute and delayed phases, during the first cycle of moderately or highly emetogenic chemotherapy (MEC and HEC, respectively) regimens. Two clinical trials evaluated NEPA over multiple cycles of chemotherapy. We report data for the delayed phase for each cycle. Methods: Both studies were Phase 3, double-blind, active-controlled studies. In study 1 (MEC), patients were randomized 1:1 to receive a single oral dose of NEPA (n = 724) or PALO 0.5 mg (n = 725) on Day 1; following cycle 1, patients could participate in a multi-cycle extension phase. In study 2 (MEC or HEC), patients were randomized 3:1 to receive a single oral dose of NEPA on Day 1 (n = 309) or oral aprepitant (APR) 125 mg plus oral PALO 0.5 mg on Day 1, then APR 80 mg/d on days 2 and 3 of each cycle (n = 103). In both studies, all patients also received dexamethasone. Efficacy endpoints included complete response (CR; no emesis, no rescue medication) and no significant nausea. Results: In both studies, CR rates were consistently numerically higher with NEPA (Study 1 range: 77%-89%; Study 2 range: 83%-93%) than with PALO (Study 1; range: 69%-83%) or APR/PALO (Study 2; range: 78%-88%) in each cycle up to cycle 6 (Table). In both studies, rates of no significant nausea in the NEPA group were similar to or higher than in the control group. NEPA was well tolerated in both studies; treatment-related adverse events included constipation and headache. Conclusions: These studies demonstrate sustained efficacy of NEPA (administered as a single dose on Day 1) across multiple cycles of MEC or HEC for prevention of CINV in the delayed phase. Clinical trial information: 2009-016775-30; 2010-023297-39. [Table: see text]

Thorough QT Study to Evaluate the Effect of Zoliflodacin, a Novel Therapeutic for Gonorrhea, on Cardiac Repolarization in Healthy Adults

2021 ◽  
Author(s):  
Lori M. Newman ◽  
Martin Kankam ◽  
Aya Nakamura ◽  
Tom Conrad ◽  
John Mueller ◽  
...  
Keyword(s):  
Oral Dose ◽  
Single Oral Dose ◽  
Cardiac Repolarization ◽  
Cardiac Safety ◽  
Double Blind ◽  
Thorough Qt Study ◽  
Regulatory Guidelines ◽  
Clinically Significant ◽  
The One ◽  
Global Threat

Zoliflodacin is a novel spiropyrimidinetrione antibiotic being developed as single oral dose treatment to address the growing global threat of Neisseria gonorrhoeae . To evaluate the cardiac safety of zoliflodacin, a thorough QT/QTc (TQT) study was performed in healthy subjects. In this randomized, double-blind, placebo-controlled, 4-period crossover study, 72 subjects in a fasted state received a single dose of zoliflodacin 2 g (therapeutic), zoliflodacin 4 g (supratherapeutic), placebo, and moxifloxacin 400 mg as a positive comparator. Cardiac repolarization was measured by duration of the corrected QT interval by Fridericia’s formula (QTcF). At each time point up to 24 hours after zoliflodacin administration, the upper limit of the one-sided 95% confidence interval (CI) for the placebo-corrected change from the pre-dose baseline in QTcF (ΔΔQTcF) was less than 10 ms, indicating an absence of a clinically meaningful increase in QT prolongation. The lower limit of the one-sided multiplicity-adjusted 95% CI of ΔΔQTcF for moxifloxacin was longer than 5 ms at four time points from 1-4 hours after dosing, demonstrating adequate sensitivity of the QTc measurement. There were no clinically significant effects on heart rate, PR and QRS intervals, ECG morphology, or laboratory values. Treatment-emergent adverse events (AEs) were mild or moderate in severity and transient. This was a negative TQT study according to regulatory guidelines (E14) and confirms that a single oral dose of zoliflodacin is safe and well-tolerated. These findings suggest zoliflodacin is not proarrhythmic and contribute to the favorable assessment of cardiac safety for a single oral dose of zoliflodacin.

scholarly journals Effect of symbiotic supplementation on fecal calprotectin levels and lactic acid bacteria, Bifidobacteria, Escherichia coli and Salmonella DNA in patients with cervical cancer

2018 ◽  
Author(s):  
Genaro Gabriel Ortiz ◽  
Luis Humberto De Loera Rodríguez ◽  
Paloma Rivero Moragrega ◽  
Irma Ernestina Velázquez Brizuela ◽  
Juan Francisco Santoscoy Gutiérrez ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Adverse Effects ◽  
Pathogenic Bacteria ◽  
The United States ◽  
Fecal Calprotectin ◽  
Control Group ◽  
Double Blind ◽  
Faecal Calprotectin ◽  
Bacterial Dna ◽  
Polymerase Chain

Background: Patients with cervical cancer (CC) receiving chemotherapy and radiotherapy have several gastrointestinal adverse effects. Objective: To evaluate the effect of dietary symbiotic supplementation on fecal calprotectin, bacterial DNA levels, and gastrointestinal adverse effects in patients with CC. Methods: Clinical, controlled, randomized, double-blind trial. Patients consumed symbiotics or placebo three times a day for 7 weeks. Fecal calprotectin was assessed by Elisa method. DNA from probiotic and pathogenic bacteria were determined by quantitative real-time polymerase chain reaction. Diarrheal evacuations were evaluated with the Bristol scale and nausea and vomiting were measured using the scale of the National Institute of Cancerology of the United States. Results: Fecal calprotectin concentration was lower in the symbiotic group compared to the control group (p <0.001). The concentrations and total proportions of the probiotic and pathogenic bacteria were similar in both groups. Nausea cases significantly diminished in both groups (p <0.001) at the end of the trial. Furthermore, the symbiotic group had a statistically significant decrease in the frequency and intensity of vomiting when compared to the control group (p <0.001). Conclusions: The symbiotic treatment decreases significantly the fecal calprotectin levels and the frequency and intensity of vomiting in patients with CC. KEYWORDS: faecal calprotectin, cervical cancer, symbiotic, qPCR.

scholarly journals Intervensi Berbasis Mindfulness untuk Menurunkan Stres pada Orang Tua

2019 ◽  
Vol 3 (1) ◽  
pp. 23
Author(s):  
Rahmantika Kurnia Romadhani ◽  
M. Noor Rochman Hadjam
Keyword(s):  
Experimental Design ◽  
Untreated Control ◽  
Statistical Test ◽  
Control Group ◽  
Untreated Control Group ◽  
Mindfulness Intervention ◽  
Quasi Experimental

The purpose of this research is to reduce parents’ stress by increasing their mindfulness ability using Mindfulness intervention. Participants in this study consisted of 15 mothers with stress from mild to severe. The design use in this study is quasi experimental design with untreated control group with pretest and postest. The program consists of 8 session intervention. The instruments used in this research are DASS Scale and KIMS scale. Quantitaive analysis was conducted through  statistical test using Mann-Whitney and also qualitative analysist. The result of this study showed that intervention with mindfulness was effective to reduce stress in parents (U=0,000; p<0,001).

scholarly journals Pelatihan “Great Mom Great Children” pada Ibu Muda Jalanan dalam Meningkatkan Ketrampilan Stimulasi Perkembangan Anak

2021 ◽  
Vol 6 (2) ◽  
pp. 1126-1134
Author(s):  
Dessy Pranungsari ◽  
Nissa Tarnoto ◽  
Fatwa Tentama
Keyword(s):  
Untreated Control ◽  
Control Group ◽  
Untreated Control Group ◽  
Control Group Design ◽  
Group Design

Anak jalanan perempuan yang memiliki anak di usia muda kurang memiliki pengetahuan dan ketrampilan dalam menstimulasi perkembangan anak. Tujuan dari penelitian ini adalah meningkatkan ketrampilan stimulasi perkembangan pada ibu-ibu muda jalanan dengan memberikan perlakuan berupa pelatihan “Great Mom Great Children”. Subjek dalam penelitian ini adalah ibu merupakan anak jalanan yang tinggal di Yogyakarta, ibu muda yang berusia kurang dari 18 tahun saat memiliki anak, ibu yang memiliki anak atas kehamilan yang tidak dikehendaki, ibu memiliki anak berusia 0-5 tahun (anak usia dini), dan ibu mengasuh anaknya sendiri secara langsung. Desain eksperimen yang digunakan adalah untreated control group design with dependent pretest and posttest samples. Alat pengumpulan data menggunakan Kuisioner Pra Skrinning Perkembangan (KPSP). Hasil Uji Wilcoxon untuk menguji perbedaan tingkat ketrampilan stimulasi ibu-ibu muda jalanan antara sebelum (pretest) dan sesudah diberi perlakuan (posttest) menunjukkan adanya perbedaan yang signifikan anatara skor pretest dan postest. Hasil Uji Mann Whitney U-test diperoleh hasil rata-rata tingkat ketrampilan stimulasi kelompok eksperimen lebih tinggi daripada kelompok kontrol. Hal ini menunjukkan bahwa metode pelatihan “Great Mom Great Children” efektif dalam meningkatkan ketrampilan stimulasi perkembangan anak pada ibu-ibu muda jalanan.

PLACEBO VS NONTREATMENT

PEDIATRICS ◽  
1996 ◽  
Vol 98 (6) ◽  
pp. 1178-1178
Author(s):  
Student
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Placebo Effect ◽  
Untreated Control ◽  
Control Group ◽  
Untreated Control Group ◽  
Nonspecific Effects

We often and wrongly equate the response seen in the placebo arm of a clinical trial with the placebo effect. In order to obtain the true placebo effect, other nonspecific effects can be identified by including an untreated control group in clinical trials.

scholarly journals Trichostrongylus and Haemonchus anthelmintic resistance in naturally infected sheep from southern Brazil

2014 ◽  
Vol 86 (2) ◽  
pp. 777-784 ◽  
Author(s):  
VANDERLEI KLAUCK ◽  
RAFAEL PAZINATO ◽  
LEANDRO S. LOPES ◽  
DIEGO C. CUCCO ◽  
HORACIO L. DE LIMA ◽  
...  
Keyword(s):  
Treatment Effect ◽  
Treatment Efficacy ◽  
Untreated Control ◽  
Anthelmintic Resistance ◽  
Small Ruminants ◽  
Infected Sheep ◽  
Control Group ◽  
Southern Brazil ◽  
Untreated Control Group ◽  
Larval Culture

The anthelmintic resistance in small ruminants is a common problem and concern worldwide. The aim of this study was to verify anthelmintic treatment efficacy in naturally infected sheep. This study was conducted on nine herds that used the same anthelmintic management for over a year. In each farm, the animals were divided into two groups: untreated control group (n = 5) and treated (n = 10) according to the number of eggs per gram of feces (EPG). The treatment effect was checked based on EPG results and larval culture performed before treatment and 10 days after treatment. Significant differences were not observed (P> 0.05) on EPG results between untreated and treated groups. The coproculture showed that the animals were infected primarily byHaemonchus spp., Trichostrongylus spp.,Teladorsagia spp., Cooperia spp. andOesophagostomum spp. In all farms, anthelmintic resistance by genera Haemonchus and Trichostrongylus was found, but this resistance varied greatly between farms.Haemonchus spp. showed resistance to closantel, levamisole, and albendazole. Trichostrongylus spp. was shown to be resistant to closantel, levamisole, and albendazole. The drugs tested showed to be efficient against the genera Teladorsagia,Cooperia, and Oesophagostomum. Based on these results, we conclude that the anthelmintic resistance to the tested drugs is a problem present in the farms evaluated.

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