Clinical Field Study Research Articles

Traditional Indigenous-Amazonian Therapy Involving Ceremonial Tobacco Drinking as Medicine: A Transdisciplinary Multi-Epistemic Observational Study.

Although the tobacco plant has been employed as a medicinal and sacred herb by Indigenous cultures across the Americas, its usage drastically changed after the 15th-century colonial arrival; its large-scale commodification and global marketing once brought to Europe lead to hedonic and addictive uses harmful to health. As a consequence, tobacco smoking is now one of the largest public health problems worldwide. However, in the Peruvian Amazon, a region of origin of tobacco species, Indigenous healers still know how to use the plant for therapeutic purposes. Due to a general disregard of Indigenous knowledge and stigma, these uses have however not so far been clinically investigated. We hence conducted for the first time a clinical field study assessing a sample of patients treated by a traditional healer specialized in tobacco in the Peruvian Amazon (observational design, pilot study, N = 27). The study was conducted within a transdisciplinary and multi-epistemic medical frame, in close partnership with an Amazonian healer. We used validated self-report scales to quantitatively assess mental health variables before and after the weeklong treatment, and mixed-methods to report experienced effects. Paired-samples t-tests comparing pre- and post-treatment scores revealed significant reductions in anxiety, depression, perceived stress, and general symptom indicators. Experienced effects included initial physical discomfort, followed by psychologically or existentially/spiritually significant insights. Our findings point to a sophisticated therapeutic approach based on Indigenous knowledge of tobacco applications, which should be further investigated. The study also contributes to the burgeoning scientific field on therapeutic uses of contentious psychoactive plants.

Measurement properties of the Portuguese version of the rheumatoid arthritis patient-reported experience measure (CQRA-PREM): a cross-sectional single center study

Aims: to test the measurement properties of the Portuguese version of the Commissioning for Quality in Rheumatoid Arthritis Patient-Reported Experience Measure (CQRA-PREM) for patients with rheumatoid arthritis (RA). Methods: This cross-sectional clinical field study recruited adult patients with RA during rheumatology appointments of a Portuguese rheumatology center. Patients completed the Portuguese version of CQRA-PREM, composed of 7 domains and 24 questions. Sociodemographic characteristics, symptoms/disease duration, current treatment, Pain-Visual Analog Scale (VAS), Patient Global Assessment (PGA)-VAS and Health Assessment Questionnaire (HAQ) were also collected from the patient. Disease Activity Score for 28 joints with C-reactive Protein (DAS28-CRP) was recorded by the rheumatologist. The assessment of CQRA-PREM measurement properties followed the Consensus-based Standards for the Selection of Health Status Measurement Instruments (COSMIN) recommendations. Results: A total of 61 patients with RA were included. The domains in which patients showed better experience were the “Needs and preferences”, followed by “Coordination and Communication”. The domain “Information, education and self-care” was an identified area of improvement for providing patient-centered care. Ceiling effects were found in four domains of the CQRA-PREM. Internal consistency of all domains was considered good (α>0.7). Homogeneity was considered good for each question in all domains analyzed (0.30≤rp≤0.70). The divergent validity of the PREM was good, revealing that the domains were not correlated (Pain-VAS, HAQ, DAS28-CRP) or only weakly (PGA-VAS) correlated with clinical outcomes. Conclusions: The CQRA-PREM showed acceptable measurement properties and is a useful tool for evaluating quality of healthcare provided in daily practice, as perceived by RA patients in Portugal.

Influence of two collection frequency intervals on sperm quality of standard and miniature bull Terriers during short breeding periods: A clinical field study.

The quality of canine sperm can be influenced by many factors, such as breed, body weight, age, ejaculatory frequency, nutrition, and environment. In the UK, it is common practice for standard Bull Terriers (SBT) and miniature Bull Terriers (MBT) to require male donors during a short breeding period. The aim of this study was to evaluate the effect of semen collection frequency on ejaculate volume and nine sperm parameters in SBT and MBT males, considering age and body condition score (BCS). Ejaculates from six adult SBTs and four MBTs were collected 5 times at two consecutive intervals (Time Series [TS]1, 24 h vs. TS2, 48 h), 1 week apart. Ejaculate volume, concentration, total output, viability (live sperm), subjective total motility, vigor, and total morphological defects, including head, midpiece, and tail defects of sperm, were evaluated. A multivariable mixed linear model for repeated measures was used to analyze the effects of semen collection frequency, age, breed, and BCS on ejaculate volume and sperm parameters. Semen collection frequency, age, and, to a lesser extent, breed, and BCS significantly affected sperm parameters. Semen collection frequency affected all sperm parameters (p < 0.05) but not ejaculate volume (p > 0.05). Total sperm output, sperm vigor, total motility, and tail defects decreased (p < 0.05) at the end of TS1. However, sperm parameters remained relatively constant (p > 0.05) in TS2 between semen collection sessions. Overall, poorer sperm parameters were observed in older dogs (aged 5-8 years) than in younger dogs (aged 4 years). MBT produced less (p < 0.001) ejaculate volume (3.2 ± 0.2 mL vs. 4.3 ± 0.2 mL: Least Squares Mean ± Standard Error of Mean), lower total sperm output (221.8 ± 19.2 × 106 vs. 348.6 ± 19.2 × 106) and lower total morphological defects (25.0 ± 1.1% vs. 31.3 ± 0.9%), and a higher percentage of live sperm (77.0 ± 1.4% vs. 71.7 ± 1.1%) than SBT. In addition, a BCS of 4 positively influenced (p < 0.05) viability, vigor, and total sperm motility. Despite differences in age, breed, and BCS, better sperm parameter values were observed in all semen collection sessions. However, intensive semen collection (TS1) appears to be less effective in maintaining good sperm quality. For breeding or artificial insemination purposes, a 48-h interval between collection sessions is recommended for both breeds. The results of this study could be used to further optimize assisted reproductive technologies in both breeds.

Assessing the daily natural history of asymptomatic Plasmodium infections in adults and older children in Katakwi, Uganda: a longitudinal cohort study

Low-density asymptomatic Plasmodium infections are prevalent in endemic areas, but little is known about their natural history. The trajectories of these infections and their propensity to fluctuate to undetectable densities can affect detection in clinical trials and field studies. We aimed to classify the natural history of these infections in a high transmission area over 29 days. In this longitudinal cohort study, we enrolled healthy, malaria-asymptomatic, afebrile, adults (age 18-59 years) and older children (age 8-17 years) in Katakwi District, Uganda, who were negative for Plasmodium infection on rapid diagnostic tests. Participants were instructed to self-collect one dried blood spot (DBS) per day for a maximum of 29 days. We excluded people if they were pregnant or taking antimalarials. During weekly clinic visits, staff collected a DBS and a 4 mL sample of venous blood. We analysed DBSs by Plasmodium 18S rRNA quantitative RT-PCR (qRT-PCR). We classified DBS by infection type as negative, P falciparum, non-P falciparum, or mixed. We plotted infection type over time for each participant and categorised trajectories as negative, new, cleared, chronic, or indeterminate infections. To estimate the effect of single timepoint sampling, we calculated the daily prevalence for each study day and estimated the number of infections that would have been detected in our population if sampling frequency was reduced. Between April 9 and May 20, 2021, 3577 DBSs were collected by 128 (40 male adults, 60 female adults, 12male children, and 16 female children) study participants. 2287 (64%) DBSs were categorised as negative, 751(21%) as positive for P falciparum, 507 (14%) as positive for non-P falciparum, and 32 (1%) as mixed infections. Daily Plasmodium prevalence in the population ranged from 45·3% (95% CI 36·6-54·1) at baseline to 30·3% (21·9-38·6) on day 24. 37 (95%) of 39 P falciparum and 35 (85%) of 41 non-P falciparum infections would have been detected with every other day sampling, whereas, with weekly sampling, 35 (90%) P falciparum infections and 31 (76%) non-P falciparum infections would have been detected. Parasite dynamics and species are highly variable among low-density asymptomatic Plasmodium infections. Sampling every other day or every 3 days detected a similar proportion of infections as daily sampling, whereas testing once per week or even less frequently could misclassify up to a third of the infections. Even using highly sensitive diagnostics, single timepoint testing might misclassify the true infection status of an individual. US National Institutes of Health and Bill and Melinda Gates Foundation.

Equine allogeneic tenogenic primed mesenchymal stem cells: A clinical field study in horses suffering from naturally occurring superficial digital flexor tendon and suspensory ligament injuries.

Mesenchymal stem cells are an innovative therapeutic for various equine orthopaedic diseases, including soft tissue injuries. To evaluate the safety and efficacy of tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells (tpMSCs) in horses with naturally occurring superficial digital flexor tendon (SDFT) and suspensory ligament (SL) injuries. Multicentre, blinded, randomised, placebo-controlled clinical trial. One hundred client-owned horses with SDFT and SL injuries were randomised to receive an intralesional tpMSC (66) or saline (34) injection. Clinical and ultrasonographic evaluation was performed before treatment and on Days 56 ± 3 and 112 ± 3 after treatment. Long-term data on re-injury was collected up to 2 years after treatment. Significantly more tpMSC-treated horses achieved improvement in fibre alignment score (FAS) (100% vs. 54.5%, p < 0.001) and echogenicity (97.0% vs. 57.6%, p < 0.001) on Day 112 ± 3, and their lesion size decreased significantly (-27.6 ± 25.91 vs. -4.6 ± 26.64 mm2, p < 0.001) compared to the placebo group. A FAS = 0 was achieved in 65% of tpMSC-treated horses, as compared to 9% of placebo-treated horses at Day 112 ± 3. The attending veterinarians reported no re-injury in 41 of 53 tpMSC and in 2 of 26 saline-treated horses available for long-term follow-up (p < 0.001). As this study consisted of client-owned horses, no samples for histology were collected. Long-term follow-up was only available for a subset of enrolled horses. The intralesional administration of tpMSCs was safe and improved the quality of healing and long-term outcomes in sports horses with naturally occurring SDFT and suspensory injuries.

Efficacy of hydrogen peroxide to reduce Gyrodactylus species infestation density on four fish species.

The ability to effectively treat parasitic infestations of fish is of high importance for fish culture facilities. However, tools or approved therapies for treating infestations on fish are limited. This paper summarizes results from four separate clinical field studies that evaluated the efficacy of hydrogen peroxide (H2 O2 ; 35% PEROX-AID) for reducing Gyrodactylus spp. infestation density. Three species of Gyrodactylus were studied (G. salmonis, hosts: Brook Trout Salvelinus fontinalis and Lake Trout S. namaycush; G. freemani, host: Yellow Perch Perca flavescens; G. hoffmani, host: Fathead Minnow Pimephales promelas) before and after the application of immersion H2 O2 therapy. Parasite density was significantly reduced for each parasite × host combination to which H2 O2 therapy was applied. Two clinical field studies in salmonids were found to demonstrate substantial effectiveness that enabled 35% PEROX-AID approval. Further assessments of Gyrodactylus spp. could expand the use of H2 O2 for controlling these parasites in aquaculture. Specifically, H2 O2 was effective at all levels tested (50 or 75 mg H2 O2 /L for 60 min for the Yellow Perch and Fathead Minnow clinical field studies; 100 or 150 mg H2 O2 /L for 30 min regardless of salt pre-treatment for the Brook Trout study; and 100 mg H2 O2 /L for 30 min or 50 mg H2 O2 /L for 60 min for the Lake Trout study).

Pregabalin Alleviates Anxiety and Fear in Cats during Transportation and Veterinary Visits-A Clinical Field Study.

Cats frequently suffer from anxiety related to travel and veterinary visits. One sequela is avoidance of veterinary visits and lack of adequate veterinary care. The objective of this study was to test clinical efficacy and safety of a novel formulation of a pregabalin 50 mg/mL oral solution for alleviation of anxiety and fear in cats during transport and veterinary visits. A total of 209 client-owned cats were given either a flavored pregabalin oral solution at the dosage of 5 mg/kg (n = 108) or an identical placebo (n = 101) approximately 90 min before placing them into the carrier and transporting them in a car for at least 20 min to a veterinary clinic. The treatment effect using a 5-point numerical rating scale was evaluated during transportation by the owner and during clinical examination by the veterinarian, both blinded to the treatment. In addition, to verify the owner assessment, an external expert blinded to the treatment and owner assessment evaluated the transportation video recordings using the same rating scale as the owner. Pregabalin 5 mg/kg statistically significantly decreased both travel- (p < 0.01) and veterinary-visit- (p < 0.01) related anxiety compared to the placebo. The external expert's evaluation was in agreement with the owners' assessment confirming the treatment effect during transportation (p < 0.01). Treatment was well tolerated with only a few cats showing transient slight incoordination and tiredness. The flavored oral solution formulation with a small dosing volume of 0.1 mL/kg was found by the owners to be user-friendly and was well-accepted by the cats. This study demonstrated that a single oral dosage of the novel pregabalin oral solution alleviates anxiety and fear related to transportation and veterinary visits in cats, thus providing practical aid for both owners and veterinarians to enable cat-friendly handling and improving the welfare of cats in situations they often perceive as very stressful.

Tasipimidine, a novel orally administered alpha-2 adrenoceptor agonist, alleviates canine acute anxiety associated with owner departure—A pilot study

Separation anxiety in dogs is a problematic behavior characterized by anxiety that occurs exclusively in the owner's absence or virtual absence, resulting in owner complaints of destructiveness, excessive vocalization, and elimination in the home. The consequences of separation anxiety may include that the owners surrender their dog to a shelter, or even have the dog euthanized. Adrenergic alpha-2 agonists have been shown to be effective in alleviating acute canine fear-based behavior problems at subsedative doses. In this study, the objective was to assess the efficacy of tasipimidine, a novel orally administered adrenergic alpha-2 agonist, in alleviating acute anxiety associated with owner departure in dogs. Twelve clinically healthy privately-owned dogs with a history of separation anxiety were enrolled in a double-blind, placebo-controlled, crossover clinical field study consisting of three 4-day treatment periods in randomized order each followed by a 3-day washout. In each treatment period a different treatment was administered. The three treatments were: placebo, tasipidimine 10ug/kg and tasipidimine 30 ug/kg, all prepared as an oral solution using the same base. At each of the 4-day treatment period study treatment was administered once daily one hour before owner´s departure. Effects of treatment on signs of separation anxiety were assessed by the owner using video recordings. Owner departure related acute anxiety severity score, dog's alertness, usability of the product and adverse events were recorded. Overall, the results showed a statistically significant treatment effect favoring tasipimidine (P= 0.001). When the doses were separately compared to placebo, the dog owners rated the effect of the study treatment more often positively after administering tasipimidine 30 µg/kg compared to placebo (OR 5.40; 95% CI 1.15-25.2; P = 0.032). A statistically significant reduction with the 30 µg/kg dose was seen in destructive/rearranging behavior (P = 0.006) and vocalization (P = 0.036). Most of the dogs were scored to be fully responsive at all time points (66.7%) and able to stand up and walk normally (91.7%), and none of the dogs was scored to be unresponsive or unable to walk. No serious adverse events were reported. The majority of the owners found the product very easy (75.0%) or easy (15.7%) to use. This was a small, cross-over study with one target to select the clinically most suitable dose. Tasipimidine should be further studied in a larger parallel group study to further evaluate its effect as a treatment option for dogs suffering from separation anxiety.

Veterinarians should understand what it means to use conditionally approved drugs, with a focus on conditional approval of companion animal oncology drugs.

The purpose of this article is to provide veterinarians with an understanding of what it means to use a conditionally approved drug. This article summarizes information that has been used to satisfy the reasonable expectation of effectiveness (RXE) standard for conditionally approved companion animal oncology drugs and compares that standard to the substantial evidence of effectiveness (SEE) standard. For conditional approval, the drug company must establish a RXE but need not demonstrate SEE. For a full approval (ie, New Animal Drug Application), the drug company must demonstrate SEE. Information to support a RXE for conditional approval of companion animal oncology drugs has included open-label pilot studies, retrospective analysis of medical records, use of a related formulation, and clinical field studies not meeting their primary effectiveness variable. Oncology drugs are highlighted in this article as they have made up many of the conditionally approved drugs to date. Veterinarians should understand that a conditionally approved drug does not have the same assurance of effectiveness as a drug receiving full approval. However, whether conditionally or fully approved, the drug has been demonstrated to be safe for the intended use. This report did not undergo scientific peer review.

Adolescents' experiences of a theory-based behavioural intervention for improved oral hygiene: A qualitative interview study.

Adequate oral hygiene, that is self-performed infection control, is crucial to prevent periodontal disease. Epidemiological studies reveal poor oral hygiene conditions among Swedish adolescents and indicate a need for more effective prevention programs. The aim of the current study was to analyse adolescents' experiences of a person-centred, theory-based, oral health education program for improved oral hygiene. Data were obtained by interviewing 19 adolescents treated by dental hygienists in accord with the person-centred education program in a preceding clinical field study (ClinicalTrials.gov NCT02906098). Study participants were selected to reflect a variation of male and female adolescents, treated at clinics in areas with various socio-demographic profiles within Region Västra Götaland, Sweden. Interviews were audio-taped, transcribed verbatim and analysed with qualitative content analysis. A main theme was identified: 'Adolescents on a guided and challenging journey towards beneficial oral hygiene behavior'. The results elucidate the importance of a person-centred approach in therapy. The adolescents described insight on a personal level about the importance of improved oral hygiene as fundamental for behavioural change. Planning and monitoring of the behaviour, with guidance and support by the dental hygienist, was considered to facilitate change and encouraged further behavioural efforts. However, the adolescents expressed a need of reminders and support to keep up oral hygiene routines over time. The study brings knowledge on factors of importance in educational interventions to increase beneficial health behaviours among adolescents and emphasize areas for further improvements of such interventions.

Innovative digital solution supporting sun protection and vitamin D synthesis by using satellite-based monitoring of solar radiation.

Public health campaigns advise minimising UV radiation (UVR)exposure to prevent skin cancer and precancer,e.g. actinic keratosis (AK). A 3-day clinical field study, in Brazil, was performed to evaluate the mobile app Sun4Health® by siHealth Ltd. The app performs real-time monitoring of both erythemal and vitamin D-effective solar radiation doses using satellite data, enabling personalised recommendations on optimal sun exposure time and sunscreen use. When coupled to a wearable device, the app also provides body-site specific recommendations ("3D" version). 59 healthy volunteers were randomised into 3 groups, each given a different app providing: (1) ultraviolet indexonly (control app), (2) personalised recommendations and sun overexposure alerts (Sun4Health® app), (3) as (2) but connected via Bluetooth to a wearable device to monitor sun exposure in 3D (Sun4Health®-3D app). Participants were offered sunscreens (SPF 30 and 50) to use at their discretion. Erythema, quantified by reflectance spectroscopy, was assessed daily in the mornings and evenings on six body sites. Serum vitamin D (25(OH)D3) was measured before and after the study. Mean increase of erythema (Mexameter® units ± SD) of all exposed body sites combined over 3days showed 55.76 ± 47.47 for group 1, 40.27 ± 37.91 for group 2 and 37.12 ± 30.69 for group 3 (p < 0.05 for all groups). Mean increase of serum 25(OH)D3 (nmol/l ± SD) showed 1.32 ± 36.49 for group 1, 6.38 ± 21.19 for group 2 and 18.68 ± 35.45 for group 3 (p > 0.05 for all groups). The results show that the Sun4Health® app is safe to use and can modify behaviour to reduce skin erythema (sunburn) yet not decreasing vitamin D status.

A person-centred, theory-based, behavioural intervention programme for improved oral hygiene in adolescents: A randomized clinical field study.

AimTo test the effectiveness of a person‐centred and theory‐based educational intervention to increase adolescents′ adherence to adequate oral hygiene behaviour, that is, self‐performed periodontal infection control.Materials and MethodsData were derived from a prospective, multi‐centred, two‐arm, quasi‐randomized field study in which treatment was performed by dental hygienists (DHs) within the Public Dental Service, Västra Götaland, Sweden. Adolescents with poor oral hygiene conditions were invited to participate. The test intervention was based on cognitive behavioural theory and principles, and the DHs used a collaborative communicative approach, inspired by motivational interviewing. The control intervention consisted of conventional information/instruction. Clinical assessments and oral hygiene behaviours were evaluated at 6 months.ResultsThree‐hundred and twelve adolescents were enrolled, of whom 274 followed the treatment to 6‐month follow‐up. There were significant improvements in gingival bleeding and plaque scores for both treatment groups at 6 months, with significantly greater improvements in the test group. Adolescents in the test group brushed their teeth and used interdental cleaning aids more frequently compared to participants in the control group at 6 months.ConclusionA person‐centred and theory‐based oral health education programme is more effective than conventional oral health education in improving adolescents' oral hygiene behaviour and periodontal infection control. ClinicalTrials.gov (NCT02906098).

Efficacy of a topical formulation containing esafoxolaner, eprinomectin and praziquantel (NexGard Combo®) against natural infestations with the cat louse, Felicola subrostratus under field conditions.

Felicola subrostratus is the only species of louse affecting domestic cats. Although it is considered a rare ectoparasite of pet cats, it occurs mainly in stray or shelter animals and is sometimes associated with intense pruritus and secondary bacterial infections. The aim of the present study was to evaluate the efficacy of a single dose of the topical formulation of esafoxolaner, eprinomectin and praziquantel (NexGard Combo®, Boehringer Ingelheim) in cats for the treatment of naturally acquired chewing lice infestation in a multi-site, positive-control, blinded clinical field study. Thirty-one domestic cats presenting natural F. subrostratus infestation were included in the study. The animals had not been treated with any ectoparasiticide within the previous 60 days. After inclusion, each cat was randomly assigned to one of the two groups: group 1, 14 cats treated with NexGard Combo® or group 2, 17 cats treated with Frontline Combo®. A clinical evaluation was performed at days 0 (inclusion), 14 and 30 and consisted in scoring the skin lesions and symptoms and scoring the presence of lice. On day 30, all cats from both groups scored 0 for the presence of live lice and no dead lice were found, demonstrating 100% efficacy. The clinical scores significantly improved from day 0 to day 30 in both groups. During the 30 days of surveillance, no reinfestations due to the hatching of eggs were observed and none of the cats had any adverse reactions. Esafoxolaner demonstrated high efficacy for the treatment of F. subrostratus infestation.

Gamithromycin in sheep: Pharmacokinetics and clinical evaluation against ovine footrot

In the context of a development program to obtain the market authorization of injectable gamithromycin 15% w/v solution (Zactran®, Boehringer Ingelheim) for use in sheep against footrot, the pharmacokinetic profile of gamithromycin was established and the safety and efficacy of the treatment were confirmed in a multicenter field study in Europe.The basic pharmacokinetic parameters established in healthy young Merino sheep administered gamithromycin at 6 mg/kg body weight based on the analysis of plasma samples which were collected in intervals up to 12 days after subcutaneous injection were: area under the curve until last quantifiable concentration, 8.88 ± 2.33 μg*h/mL; maximum plasma concentration, 448 ± 180 ng/mL; terminal half-life, 42.5 ± 5.25 h.The safety and clinical efficacy against footrot of gamithromycin 15% w/v solution were evaluated in comparison to tilmicosin 30% w/v solution (Micotil®, Elanco) treatment in 364 sheep of various breeds, sex and age from commercial farms in the United Kingdom (2 sites), Germany (3 sites) and France (1 site). Animals were enrolled based on lesions characteristic of footrot and lameness associated with the presence of footrot-related bacterial pathogens and were randomly allocated and treated in a 1:1 ratio with a single subcutaneous dose of gamithromycin or tilmicosin at label dosage (6 or 10 mg/kg body weight, respectively). Lameness and footrot lesions were evaluated at five and 21 days after treatment; the injection site in all animals was examined the day after treatment and followed up daily in the animals with injection site reaction until complete injection site reaction resolution.Samples of 310 and 120 animals tested positive for Dichelobacter nodosus and Fusobacterium necrophorum, respectively, at inclusion, and data of 359 animals were included into the combined analyses (5 animals excluded for unintentional overdosing [1], lack of follow-up [1], concurrent antibiotic medication for non-footrot conditions [3]). Lameness scores at 21 days after treatment demonstrated a significantly (p = 0.0396) better success for the gamithromycin treatment compared to the tilmicosin treatment (97.8% vs. 93.3%). Post-dosing footrot lesion scores followed similar trends of rapid and marked decrease (improvement) for both treatments with similar (p = 0.127) treatment success for the gamithromycin and tilmicosin treatments (97.8% and 96.0%, respectively). Both treatments were safe; injection site reactions noted in 19 gamithromycin- and 25 tilmicosin-treated animals resolved within five days or six days of treatment, respectively.Gamithromycin 15% w/v solution administered once to sheep by subcutaneous injection at 6 mg/kg body weight demonstrated a pharmacokinetic profile similar to that reported previously in sheep and cattle and was confirmed to be a safe and efficacious treatment for naturally occurring ovine footrot in a multicenter clinical field study conducted in Europe.

Dexmedetomidine oromucosal gel reduces fear and anxiety in dogs during veterinary visits: A randomised, double-blind, placebo-controlled clinical pilot study.

Many dogs are anxious and/or fearful in veterinary clinics and exhibit avoidant and/or defensive behaviour. The purpose of pharmacological interventions is to reduce anxiety and to enable patient-friendly, low stress physical examination and procedures. This was a randomised, double-blind, placebo-controlled, parallel-group, multicentre, clinical-field study. The eligible dogs (n=76) were randomly assigned to receive dexmedetomidine 0.1mg/g oromucosal gel at a dose of 125μg/m2 (n=27) or 250μg/m2 (n=24), or an equivalent volume of placebo gel (n=23). The investigator's ability to perform the intended procedure (physical examination and 1 short minor veterinary or husbandry procedure) was excellent for 40.7% of the dogs that received dexmedetomidine 125 μg/m2 and 33.3% of those that received dexmedetomidine 250 μg/m2 compared to only 4.3% of the placebo dogs. The overall treatment effect was statistically significant (p=0.03). In addition, the investigators subjective stress level assessments revealed that dexmedetomidine treated dogs showed significantly more commonly relaxed body posture (p<0.01) and more relaxed behaviour when entering the examination room (p=0.02). There were very few adverse events, and treated animals were not sedated. This study indicated a beneficial treatment effect of dexmedetomidine gel in alleviation of canine fear and anxiety during minor veterinary or husbandry procedures in the clinic environment in dogs previously reported to suffer from fear and anxiety during veterinary visits. Both dexmedetomidine gel doses studied were effective, and no clinical safety concerns were noticed for either dose.

Field study to investigate the effectiveness and safety of a novel orally administered combination drug product containing milbemycin oxime and lotilaner (Credelio\xae Plus) for the prevention of heartworm disease (Dirofilaria immitis) in client-owned dogs in the USA

BackgroundDirofilaria immitis, a globally distributed filarial parasite of dogs, is known to cause serious or fatal cardiopulmonary disease. Client-owned dogs were enrolled in a clinical field study in the USA to evaluate the clinical effectiveness and field safety of an orally administered combination investigational product (IP) containing milbemycin oxime and lotilaner (Credelio® Plus) as compared to a control product (CP) for the prevention of heartworm disease when administered monthly for 11 consecutive months.MethodsIn this 11-month field study, 319 dogs ≥ 8 weeks old confirmed to be heartworm-negative were enrolled from eight geographically distinct US veterinary clinics, including sites in the southern USA and Mississippi River Valley. The dogs were treated with either the IP combination product at 0.75–1.53 mg/kg milbemycin oxime and 20–41.5 mg/kg lotilaner (n = 159) or the CP (Sentinel® Flavor Tabs®; milbemycin oxime/lufenuron) at the label-recommended dose rate (n = 158.) On day 330, effectiveness was evaluated in each dog using antigen and microfilarial (modified Knott’s) testing to assess the establishment of any patent adult heartworm infections.ResultsAll dogs treated with the IP combination product and the CP tested negative (100% prevention) for heartworm infection on day 330. The IP combination product tablets containing milbemycin oxime and lotilaner were well tolerated based on the safety assessments in all treated dogs.ConclusionsThis multi-site clinical study using client-owned dogs demonstrated that monthly use of flavored, chewable tablets containing a combination of milbemycin oxime and lotilaner administered orally under end use conditions is safe for dogs. None of the enrolled dogs developed heartworm infections. Eleven consecutive monthly treatments of the IP provided 100% prevention of heartworm disease caused by D. immitis.Graphical

The effectiveness of various antibacterial drugs in the treatment of swine respiratory diseases

The polyethiological nature of pig respiratory diseases involves the use of antibacterial drugs of the widest possible spectrum of action. The success of the whole range of therapeutic measures will largely depend on the choice of antibacterial drugs. This article presents the results of a clinical (field) study evaluating the effectiveness of azithromycin, florfenicol and amoxicillin in respiratory diseases of pigs under conditions of contamination with associates of highly resistant pathogens (Mycoplasma spp., Hemolytic coagulase-positive Staph.aureus, non-hemolytic Lac-coli fermenting E. hemolytic Enterococcus faecalis, Klebsiella pneumoniae, Klebsiella oxytoca, Morganella morganii, Pseudomonas aeruginosa, Proteus mirabillis, Enterobacter aerogenes, Enterobacter cloacae). The study included 90 crossbred piglets 100-110 days old with pronounced clinical signs of respiratory diseases. In the course of the work, the dynamics of changes in the state of piglets was assessed: the rate of disappearance of clinical signs, the average daily weight gain, the presence of associates of highly resistant microorganisms after a course of treatment, the mortality rate and the number of adverse events and side reactions. The results of the study revealed the formation of multidrug resistance in a number of pathogens. Preparations based on florfenicol and azithromycin showed higher therapeutic efficacy in the treatment of respiratory diseases of piglets under conditions of contamination of associates of highly resistant pathogens.

Use of Detomidine Oromucosal Gel for Alleviation of Acute Anxiety and Fear in Horses: A Pilot Study.

The aim of this randomized, double-blind, placebo-controlled, parallel group clinical field study was to evaluate the effect of detomidine oromucosal gel in alleviating anxiety and fear in horses. Sixteen horses with a history of acute anxiety and fear associated with firework-related noise entered the study. On New Year's Eve, eight horses were treated with 30 μg/kg detomidine gel and eight horses with placebo gel. When fireworks were present, 75% (6/8) of the detomidine-treated horses were scored by their owners as having a good or excellent treatment effect on anxiety and fear, while 50% (3/6) of horses receiving placebo were scored to have a good effect. Horses' behavior was video-recorded and assessed with a focal animal continuous method by a treatment-blind expert observer. Results showed that when fireworks were present, walking behavior decreased significantly (p < 0.05) after treatment with detomidine and that horses of the placebo group, overall, showed more restlessness, vocalization, and signs of colic (Wilcoxon matched-pairs test on the first PC, p = 0.007). This study indicates that detomidine oromucosal gel can be used to alleviate acute noise-related anxiety and fear in horses, but larger treatment groups are needed to confirm the results.

Large Multisite Clinical Field Study Characterizing Contamination Levels in Patient Used Endoscopes After Manual Cleaning

Background: Multiple outbreaks multidrug-resistant organisms (MDROs) have been associated with flexible endoscopes resulting in unacceptable patient mortality and morbidity. Evidence highlights the importance of effective cleaning to achieve effective high-level disinfection (HLD). This study presents an analysis of &gt;700,000 measurements of adenosine-triphosphate (ATP) contamination levels found in flexible endoscopes after manual cleaning. Method: This 2018–2019 study consists of 702,768 measurements of ATP levels found in the suction/biopsy channel of instruments used on patients after manual cleaning: gastroscopes (267,533 measurements from 223 sites), duodenoscopes (123,697 measurements from 161 sites), colonoscopes (252,249 measurements from 229 sites), and bronchoscopes (59,289 measurements from 107 sites). Sites were located across the United States and employed protocols that included routine cleaning verification performed by the reprocessing technicians using a handheld luminometer and the associated ATP water test (3M Clean-Trace). Results: Figure 1 shows a boxplot analysis of the ATP levels by endoscope type. Upper gastrointestinal (GI) endoscopes (gastroscopes and duodenoscopes) show a significantly (P &lt; .005) greater level of ATP contamination after manual cleaning. The pairwise mean differences are all significant (P &lt; .005) except for colonoscopes when compared to bronchoscopes (P = .203). Also shown on Fig. 1 is a literature supported adequate cleanliness value of 200 RLUs [=2.3log(RLUs)] (MJ Alfa et al.; Am J Infec Control 2013;41:245–253 and ANSI/AAMI ST91; 2015). A 95% confidence interval analysis performed against this literature value (Table 1) showed that a high number of gastroscopes (12%) and duodenoscopes (10%) are not adequately clean. Figure 2 shows a box-plot analysis of the data set by endoscope type and by site. There is significant (P &lt; .005) site-to-site variability for all endoscope types as demonstrated by variation in mean values, box size, and many outliers. Conclusions: This study highlights the importance of using a quantitative cleaning verification method to better understand process capability and to provide more robust quality assurance for manual cleaning. Significant differences were detected in the level of cleanliness between upper GI scopes and lower GI scopes and bronchoscopes. When compared to a literature-supported level for adequate cleanliness, upper GI scopes exhibited failure rates in excess of 10%. Furthermore, significant site-to-site variability occurred, and many outliers fell well beyond the normal process envelope, representing significant cleaning lapses. Root causes to these concerning findings could range from inadequate execution of the cleaning protocol, to device design, to age and existing damage that could prevent achieving adequate cleaning and possibly impair the effectiveness of HLD.Funding: NoneDisclosures: Marco Bommarito, 3M (salary)

Clinical, Epidemiological and Experimental Approaches to Assess Adverse Health Outcomes of Indoor Biomass Smoke Exposure: Conclusions from An Indo-Swedish Workshop in Mysuru, January 2020

This report summarizes the outcome of a workshop held in Mysuru, India in January 2020 addressing the adverse health effects of exposure to biomass smoke (BMS). The aim of the workshop was to identify uncertainties and gaps in knowledge and possible methods to address them in the Mysuru study on Determinants of Health in Rural Adults (MUDHRA) cohort. Specific aims were to discuss the possibility to improve and introduce new screening methods for exposure and effect, logistic limitations and other potential obstacles, and plausible strategies to overcome these in future studies. Field visits were included in the workshop prior to discussing these issues. The workshop concluded that multi-disciplinary approaches to perform: (a) indoor and personalized exposure assessment; (b) clinical and epidemiological field studies among children, adolescents, and adults; (c) controlled exposure experiments using physiologically relevant in vitro and in vivo models to understand molecular patho-mechanisms are warranted to dissect BMS-induced adverse health effects. It was perceived that assessment of dietary exposure (like phytochemical index) may serve as an important indicator for understanding potential protective mechanisms. Well trained field teams and close collaboration with the participating hospital were identified as the key requirements to successfully carry out the study objectives.