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1.
Article in English | MEDLINE | ID: mdl-38649529

ABSTRACT

INTRODUCTION: Research in various areas indicates that expert judgment can be highly inconsistent. However, expert judgment is indispensable in many contexts. In medical education, experts often function as examiners in rater-based assessments. Here, disagreement between examiners can have far-reaching consequences. The literature suggests that inconsistencies in ratings depend on the level of performance a to-be-evaluated candidate shows. This possibility has not been addressed deliberately and with appropriate statistical methods. By adopting the theoretical lens of ecological rationality, we evaluate if easily implementable strategies can enhance decision making in real-world assessment contexts. METHODS: We address two objectives. First, we investigate the dependence of rater-consistency on performance levels. We recorded videos of mock-exams and had examiners (N=10) evaluate four students' performances and compare inconsistencies in performance ratings between examiner-pairs using a bootstrapping procedure. Our second objective is to provide an approach that aids decision making by implementing simple heuristics. RESULTS: We found that discrepancies were largely a function of the level of performance the candidates showed. Lower performances were rated more inconsistently than excellent performances. Furthermore, our analyses indicated that the use of simple heuristics might improve decisions in examiner pairs. DISCUSSION: Inconsistencies in performance judgments continue to be a matter of concern, and we provide empirical evidence for them to be related to candidate performance. We discuss implications for research and the advantages of adopting the perspective of ecological rationality. We point to directions both for further research and for development of assessment practices.

2.
Microbiol Resour Announc ; 13(6): e0016524, 2024 Jun 11.
Article in English | MEDLINE | ID: mdl-38682771

ABSTRACT

Thirteen bacterial isolates of Tenacibaculum maritimum were sequenced and assembled. The strains were isolated from four disease outbreaks in farmed marine fish in Norway. Eight isolates were from Cyclopterus lumpus (lumpfish), and five were from Scophthalmus maximus (turbot). Overall, sequence similarity did not correlate with host species or geographic location.

3.
Euro Surveill ; 29(10)2024 Mar.
Article in English | MEDLINE | ID: mdl-38456219

ABSTRACT

Gonorrhoea cases increased steeply in women aged 20 to 24 years across 15 EU/EEA countries in July to December 2022 and January to June 2023 with, respectively, 73% and 89% more cases reported than expected, based on historical data from 2015 to 2019. Smaller increases among men due to heterosexual transmission were observed in nine EU/EEA countries. Interventions to raise awareness among young people about sexually transmitted infection risks are needed, emphasising the benefit of safe sexual practices and testing.


Subject(s)
Gonorrhea , Sexually Transmitted Diseases , Male , Humans , Female , Adolescent , Gonorrhea/epidemiology , Sexually Transmitted Diseases/epidemiology , Sexual Behavior , Heterosexuality
4.
Acta Psychiatr Scand ; 149(2): 147-167, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38072917

ABSTRACT

OBJECTIVE: Offspring of parents with schizophrenia spectrum disorders (SSD) have an increased risk of neurodevelopmental disturbances. However, the ability to provide very early interventions to support these children and their families requires profound knowledge regarding characteristic features of both the parents and their offspring. Information on this subject is currently sparse. The aim of the present study is to investigate clinical and sociodemographic variables in offspring in the age range of 0-3 years of mothers diagnosed with SSD. METHODS: The study is descriptive with a cross-sectional design and includes parent-child dyads consisting of mothers diagnosed with SSD (ICD-10: F20-29) and their offspring aged 0-3 years, who were referred for examination and intervention at the infant and toddler psychiatric units, at the Mental Health Services, Capital Region, Copenhagen University Hospitals in two locations (Bispebjerg and Glostrup). Clinical and sociodemographic data were extracted from the Copenhagen "Infant Psychiatric Database" and processed by descriptive analysis. RESULTS: Out of 95 parent-child dyads considered for the study population, 85 were included. 27.8% of the mothers had psychiatric comorbidities, and 18.9% of the fathers had a psychiatric diagnosis at the time of investigation. Of the children, 89.7% were born full term (≥37th week) and most of them had a birth weight of ≥2500 g (81.8%). Of the mothers, 50% had experienced pregnancy complications of varying severity. Birth complications were seen in 62.9% of the dyads. Psychopathology was identified in 50% of the children at age 0-3 years, and 62.2% of the parent-child dyads appeared to have an affected relationship. CONCLUSION: Results show widespread psychopathology in offspring aged 0-3 years of mothers with SSD. Moreover, several psychosocial stressors, clinical parental features, and relational disturbances are identified. These results contribute to a better understanding and identification of early risk markers of long-term psychopathology in this infant patient group, and hence serve as potential targets for early interventions.


Subject(s)
Child of Impaired Parents , Mental Disorders , Schizophrenia , Female , Infant , Pregnancy , Humans , Infant, Newborn , Child, Preschool , Schizophrenia/epidemiology , Cross-Sectional Studies , Mothers/psychology , Mental Disorders/epidemiology , Psychopathology , Parents/psychology , Child of Impaired Parents/psychology
5.
Front Microbiol ; 14: 1236290, 2023.
Article in English | MEDLINE | ID: mdl-37808299

ABSTRACT

The present study was undertaken to address the recent spate of pasteurellosis outbreaks among sea-farmed Atlantic salmon (Salmo salar) in Norway and Scotland, coinciding with sporadic disease episodes in lumpfish (Cyclopterus lumpus) used for delousing purposes in salmon farms. Genome assemblies from 86 bacterial isolates cultured from diseased salmon or lumpfish confirmed them all as bona fide members of the Pasteurellaceae family, with phylogenetic reconstruction dividing them into two distinct branches sharing <88% average nucleotide identity. These branches therefore constitute two separate species, namely Pasteurella skyensis and the as-yet invalidly named "Pasteurella atlantica". Both species further stratify into multiple discrete genomovars (gv.) and/or lineages, each being nearly or fully exclusive to a particular host, geographic region, and/or time period. Pasteurellosis in lumpfish is, irrespective of spatiotemporal origin, linked almost exclusively to the highly conserved "P. atlantica gv. cyclopteri" (Pac). In contrast, pasteurellosis in Norwegian sea-farmed salmon, dominated since the late-1980s by "P. atlantica gv. salmonicida" (Pas), first saw three specific lineages (Pas-1, -2, and -3) causing separate, geographically restricted, and short-lived outbreaks, before a fourth (Pas-4) emerged recently and became more widely disseminated. A similar situation involving P. skyensis (Ps) has apparently been unfolding in Scottish salmon farming since the mid-1990s, where two historic (Ps-1 and -2) and one contemporary (Ps-3) lineages have been recorded. While the epidemiology underlying all these outbreaks/epizootics remains unclear, repeated detection of 16S rRNA gene amplicons very closely related to P. skyensis and "P. atlantica" from at least five cetacean species worldwide raises the question as to whether marine mammals may play a part, possibly as reservoirs. In fact, the close relationship between the studied isolates and Phocoenobacter uteri associated with harbor porpoise (Phocoena phocoena), and their relatively distant relationship with other members of the genus Pasteurella, suggests that both P. skyensis and "P. atlantica" should be moved to the genus Phocoenobacter.

6.
Article in English | MEDLINE | ID: mdl-37493835

ABSTRACT

Co-occurring regulatory problems in infancy, RPs, including excessive crying, feeding-eating and sleeping, have been found associated with mental health problems in school ages. Still, an overview is needed on trajectories of co-occurring or combined RPs, and mental health problems in early childhood. The aim of this review is to systematically review the literature on longitudinal community-based studies of combined RPs measuring mental health outcomes in early childhood. Following the PRISMA guideline, we systematically reviewed the literature published 2000-2020, in which combined RPs are assessed in infancy, and mental health is examined using standardised measures at ages 1-7 years. The search was performed in four databases MEDLINE, EMBASE, PsycINFO and Scopus. A protocol is published on PROSPERO. Based on 1978 screened articles, 42 papers were screened for eligibility, of which six were included, comprising data on two or more RPs investigated among a total of 20,675 children. Assessment of risk of bias in the studies showed overall good quality in five of the six papers. The literature reviewed suggests that combined RPs in infancy are early markers of mental health problems during early childhood, and highlights that community studies exploring the longitudinal associations of combined RP and mental health problems in preschool and early school age are still scarce. Overall, the review points to the need of research into preventive intervention targeting early manifestations of childhood dysregulation, such as RPs.

8.
J Endocr Soc ; 7(6): bvad054, 2023 May 05.
Article in English | MEDLINE | ID: mdl-37197408

ABSTRACT

Context: Effectiveness and safety data on GH replacement therapy (GHRT) in older adults with adult GH deficiency (AGHD) are limited. Objective: To compare GHRT safety and clinical outcomes in older (≥60 years and, for some outcomes, ≥75 years) and middle-aged (35-<60 years) patients with AGHD. Design/setting: Ten-year follow-up, real-world data from 2 large noninterventional studies-NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program-were analyzed. Patients: GH-naïve and non-naïve patients with AGHD. Intervention: Norditropin® (somatropin). Main outcome measures: Outcomes included GH exposure, IGF-I standard deviation scores (SDS), body mass index (BMI), glycated hemoglobin (HbA1c), serious and nonserious adverse reactions (SARs and NSARs, respectively), and serious adverse events (SAEs). Adverse reactions were events with possible/probable causal relationship to GHRT. Results: The effectiveness analysis set comprised 545 middle-aged and 214 older patients (19 aged ≥75 years) from NordiNet® IOS. The full analysis set comprised 1696 middle-aged and 652 older patients (59 aged ≥75 years) from both studies. Mean GH doses were higher in middle-aged vs older patients. For both age groups and sexes, mean IGF-I SDS increased following GHRT, while BMI and HbA1c changes were similar and small.Incidence rate ratios (IRRs) did not differ statistically between older and middle-aged patients for NSARs [IRR (mean, 95% confidence interval) 1.05 (.60; 1.83)] or SARs [.40 (.12; 1.32)]. SAEs were more frequent in older than middle-aged patients [IRR 1.84 (1.29; 2.62)]. Conclusion: Clinical outcomes of GHRT in AGHD were similar in middle-aged and older patients, with no significantly increased risk of GHRT-related adverse reactions in older patients.

9.
Heliyon ; 9(2): e13071, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36747535

ABSTRACT

This article proposes a more individualized approach to organizational and food safety culture development through the creation of culture change agents. The study used action research with individual therapeutic training of sensory and emotional skills as the action intervention to reveal underlying mechanisms of the culture and create long-term culture change. The study was conducted with a group of voluntary employees over a 3-year period at a department under Food Safety and Veterinary Issues in Danish Agriculture and Food Council. Data was collected using individual in-depth qualitative interviews with a novel questionnaire technique that facilitated participants to bring otherwise unconscious underlying assumptions to awareness. The study found that working intensely and therapeutically on an individual and group level, had a significant impact on the surrounding culture and social capital. Five underlying mechanisms were revealed linking individual culture change to changes in the social capital and culture of the department. Going through the five underlying mechanisms may enable individuals to get to the root causes of issues, facilitate more sharing and collaboration to learn from near-misses and failures, and take action despite facing uncomfortable situations, all important abilities to develop FSC. Based on the underlying mechanisms a 'Change Agent Model' was developed. The model illustrates the important underlying mechanisms that any individual or group can work through to become culture change agents and drivers for organizational culture and FSC development. This is the first of two articles.

10.
Front Vet Sci ; 10: 1112466, 2023.
Article in English | MEDLINE | ID: mdl-36846252

ABSTRACT

Piscine orthoreovirus genotype 3 (PRV-3) was first discovered in Denmark in 2017 in relation to disease outbreaks in rainbow trout (Oncorhynchus mykiss). While the virus appears to be widespread in farmed rainbow trout, disease outbreaks associated with detection of PRV-3 have only occurred in recirculating aquaculture systems, and has predominantly been observed during the winter months. To explore the possible effects of water temperature on PRV-3 infection in rainbow trout, an in vivo cohabitation trial was conducted at 5, 12, and 18°C. For each water temperature, a control tank containing mock-injected shedder fish and a tank with PRV-3 exposed fish were included. Samples were collected from all experimental groups every 2nd week post challenge (WPC) up until trial termination at 12 WPC. PRV-3 RNA load measured in heart tissue of cohabitants peaked at 6 WPC for animals maintained at 12 and 18°C, while it reached its peak at 12 WPC in fish maintained at 5°C. In addition to the time shift, significantly more virus was detected at the peak in fish maintained at 5°C compared to 12 and 18°C. In shedders, fish at 12 and 18°C cleared the infection considerably faster than the fish at 5°C: while shedders at 18 and 12°C had cleared most of the virus at 4 and 6 WPC, respectively, high virus load persisted in the shedders at 5°C until 12 WPC. Furthermore, a significant reduction in the hematocrit levels was observed in the cohabitants at 12°C in correlation with the peak in viremia at 6 WPC; no changes in hematocrit was observed at 18°C, while a non-significant reduction (due to large individual variation) trend was observed at cohabitants held at 5°C. Importantly, isg15 expression was positively correlated with PRV-3 virus load in all PRV-3 exposed groups. Immune gene expression analysis showed a distinct gene profile in PRV-3 exposed fish maintained at 5°C compared to 12 and 18°C. The immune markers mostly differentially expressed in the group at 5°C were important antiviral genes including rigi, ifit5 and rsad2 (viperin). In conclusion, these data show that low water temperature allow for significantly higher PRV-3 replication in rainbow trout, and a tendency for more severe heart pathology development in PRV-3 injected fish. Increased viral replication was mirrored by increased expression of important antiviral genes. Despite no mortality being observed in the experimental trial, the data comply with field observations of clinical disease outbreaks during winter and cold months.

11.
J Fish Dis ; 46(5): 535-543, 2023 May.
Article in English | MEDLINE | ID: mdl-36787245

ABSTRACT

A Multi-Locus Variable number of tandem repeat Analysis (MLVA) genotyping scheme was developed for the epidemiological study of Moritella viscosa, which causes 'winter ulcer' predominantly in sea-reared Atlantic salmon (Salmo salar L.). The assay involves multiplex PCR amplification of six Variable Number of Tandem Repeat (VNTR) loci, followed by capillary electrophoresis and data interpretation. A collection of 747 spatiotemporally diverse M. viscosa isolates from nine fish species was analysed, the majority from farmed Norwegian salmon. MLVA distributed 76% of the isolates across three major clonal complexes (CC1, CC2 and CC3), with the remaining forming minor clusters and singletons. While 90% of the salmon isolates belong to either CC1, CC2 or CC3, only 20% of the isolates recovered from other fish species do so, indicating a considerable degree of host specificity. We further highlight a series of 'clonal shifts' amongst Norwegian salmon isolates over the 35-year sampling period, with CC1 showing exclusive predominance prior to the emergence of CC2, which was later supplanted by CC3, before the recent re-emergence of CC1. Apparently, these shifts have rapidly swept the entire Norwegian coastline and conceivably, as suggested by typing of a small number of non-Norwegian isolates, the Northeast Atlantic region as a whole.


Subject(s)
Fish Diseases , Moritella , Salmo salar , Animals , Genotype , Agriculture
12.
Diabetes Obes Metab ; 25(4): 985-991, 2023 04.
Article in English | MEDLINE | ID: mdl-36514273

ABSTRACT

AIM: To assess the in-market use of Saxenda (liraglutide 3.0 mg) and Victoza (liraglutide 1.2 mg/1.8 mg) according to approved indications and posology. MATERIALS AND METHODS: This retrospective, non-interventional study was conducted at 41 sites from December 2016 to May 2019. Via medical record review, physicians at each site identified patients who had been prescribed Saxenda (Italy) or Victoza (Italy/Germany) within the 24 months following launch in each country. Pseudonymized data were abstracted on patient and site characteristics, indication for the prescription, posology and duration of usage. Adherence to the approved indications and posology, and to the Saxenda stopping rule, were assessed. No formal statistical analysis was performed. RESULTS: A total of 440 patients were prescreened and 225 (51.1%) were enrolled (Saxenda: N = 75, all in Italy; Victoza: N = 75 in Italy and N = 75 in Germany). In all, 96% (72/75) of Saxenda prescriptions, and 98.7% (148/150) of Victoza, were in accordance with the approved indications. Among the 40 patients treated with Saxenda for 16 weeks or longer, only two (5.0%) were confirmed as non-adherent to the stopping rule. Adherence could not be assessed in 23 (57.5%) patients because of missing body weight measurements. CONCLUSIONS: This retrospective, real-world post-authorization safety study provides reassurance that Saxenda and Victoza are primarily used according to the approved European label, thus their real-world utilization did not raise safety concerns.


Subject(s)
Diabetes Mellitus, Type 2 , Liraglutide , Humans , Liraglutide/therapeutic use , Hypoglycemic Agents/therapeutic use , Retrospective Studies , Europe , Italy , Diabetes Mellitus, Type 2/drug therapy
13.
J Geriatr Oncol ; 14(1): 101382, 2023 01.
Article in English | MEDLINE | ID: mdl-36328878

ABSTRACT

INTRODUCTION: Older and frail patients with cancer are at high risk of physical and functional decline during chemotherapy. Exercise interventions can often counteract chemotherapy related toxicity and may help patients to improve or retain physical function and quality of life. Studies evaluating feasibility and the effect of exercise in older patients are lacking. The aim of this study was to investigate the feasibility and effect of an exercise intervention in older frail patients during chemotherapy for colorectal cancer (CRC). MATERIALS AND METHODS: This is a secondary analysis from the GERICO study investigating the effect of geriatric interventions in frail patients ≥70 years receiving chemotherapy for CRC. All patients in the present analysis were patients randomized to geriatric interventions and who were found physically frail (low handgrip strength or slow 10 m gait speed) and therefore offered referral to the exercise program for twelve weeks. We evaluated reasons for dropping out and feasibility of an individually tailored exercise program twice a week for twelve weeks. Each 60 min session comprised warm-up followed by progressive resistance training and cool-down followed by an oral protein supplement. Baseline characteristics and the effect of exercise for patients with high and low adherence (attendance of <50% of exercise sessions) were compared. RESULTS: Of 71 patients in the intervention group, 47 (66%) were found physically frail and were offered referral to the exercise program. Seven patients were referred to municipal physiotherapy before study start. In the remaining population (N = 40) 19 had exercise adherence >50% and 21 had no or low exercise adherence. Baseline characteristics were similar between patients with high and low/no adherence, except for sex (68% and 33% were men in high and low/ no adherence group, respectively). Patients with >50% attendance had significant improvements in physical tests after twelve weeks of exercise. DISCUSSION: Low adherence to the exercise program was seen due to lack of energy and/or treatment related adverse events. Patients with high adherence benefitted from exercise during chemotherapy but did not differ from patients with low adherence at baseline. Consequently, exercise should be offered to all older frail patients receiving chemotherapy for CRC.


Subject(s)
Colorectal Neoplasms , Frail Elderly , Male , Aged , Humans , Female , Quality of Life , Hand Strength , Feasibility Studies , Exercise Therapy
15.
Endocr Connect ; 12(1)2023 Jan 01.
Article in English | MEDLINE | ID: mdl-36347049

ABSTRACT

Adult growth hormone deficiency (AGHD) is associated with an increased risk of cardiovascular (CV) disease. Long-term growth hormone (GH) treatment could improve CV outcomes. The objective of this study was to evaluate CV disease risk in patients with AGHD who received GH replacement therapy for up to 10 years as part of NordiNet® IOS (NCT00960128) and the ANSWER Program (NCT01009905). The studies were observational, non-interventional and multicentre, monitoring long-term effectiveness and safety of GH treatment. NordiNet® IOS involved 23 countries (469 sites) across Europe and the Middle East. The ANSWER Program was conducted in the USA (207 sites). This analysis included patients aged 18-75 years who were GH naïve at study entry, who had ≤10 years of GH treatment data and who could be assessed for CV risk for at least 1 follow-up year. The main outcome measure was risk of CV disease by age 75 years, as calculated with the Multinational Cardiovascular Risk Consortium model (Brunner score) using non-high-density lipoprotein cholesterol adjusted for age, sex and CV risk factors. The results of this analysis showed that CV risk decreased gradually over the 10-year period for GH-treated patients. The risk was lower for patients treated for 2 and 7 years vs age- and sex-matched control groups (not yet started treatment) (14.51% vs 16.15%; P = 0.0105 and 13.53% vs 16.81%; P = 0.0001, respectively). This suggests that GH treatment in people with AGHD may reduce the risk of CV disease by age 75 years compared with matched controls.

16.
BMJ Open ; 12(12): e064934, 2022 12 01.
Article in English | MEDLINE | ID: mdl-36456026

ABSTRACT

OBJECTIVES: We estimate the prevalence of sexually transmitted infection (STI) among patients after sexual assault, assess the possible value of azithromycin prophylaxis, and identify risk factors for assault-related STI and for not presenting at follow-up. DESIGN: Prospective observational cohort study. SETTING: Sexual assault centre in Oslo, Norway. PARTICIPANTS: 645 patients, 602 (93.3%) women and 43 (6.7%) men, attending the centre from May 2017 to July 2019. OUTCOME MEASURES: Microbiological testing at the primary examination and at follow-up consultations after 2, 5 and 12 weeks. Estimated relative risk for assault-related STI and for not presenting at follow-up. RESULTS: At primary examination, the prevalence of genital chlamydia was 8.4%, Mycoplasma genitalium 6.4% and gonorrhoea 0.6%. In addition, the prevalence of bacterial STI diagnosed at follow-up and possibly from the assault was 3.0% in total: 2.5% for M. genitalium, 1.4% for genital chlamydia and 0.2% for gonorrhoea. This prevalence did not change when azithromycin was no longer recommended from January 2018. There were no new cases of hepatitis B, hepatitis C, HIV or syphilis. We found no specific risk factors for assault-related STI. Patients with previous contact with child welfare service less often presented to follow-up (relative risk (RR) 2.0 (95% CI 1.1 to 3.5)), as did patients with a history of sex work (RR 3.6 (1.2 to 11.0)) or substance abuse (RR 1.7 (1.1 to 2.7)). CONCLUSIONS: Most bacterial STIs were diagnosed at the primary examination, hence not influenced by prophylaxis. There was no increase in bacterial STI diagnosed at follow-up when azithromycin prophylaxis was not routinely recommended, supporting a strategy of starting treatment only when infection is diagnosed or when the patient is considered at high risk. Sex work, substance abuse and previous contact with child welfare services were associated with not presenting to follow-up. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03132389).


Subject(s)
Gonorrhea , Sex Offenses , Sexually Transmitted Diseases , Child , Male , Humans , Female , Cohort Studies , Azithromycin/therapeutic use , Prospective Studies , Sexually Transmitted Diseases/epidemiology , Norway/epidemiology
17.
Transbound Emerg Dis ; 69(5): e3305-e3315, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35674219

ABSTRACT

Tenacibaculum piscium, a gram-negative bacterium isolated from the skin ulcers of sea-farmed fish, has only been described in Norway. In the present study, we examined 16 Chilean Tenacibaculum isolates recovered from different organs in moribund and dead Atlantic salmon (Salmo salar), Rainbow trout (Oncorhynchus mykiss) and Coho salmon (Oncorhynchus kisutch) cultured at different fish farms between 2014 and 2018. The present study applied biochemical, phenotypic, fatty acid and whole-genome sequence-based analyses to confirm the taxonomic status of the Chilean isolates. The obtained results are the first to confirm the presence of T. piscium in Chile and in Coho salmon, thus extending the recognized geographical and species distribution of this bacterium. Subsequent bath-challenge assays in Atlantic salmon utilizing three T. piscium isolates obtained from different hosts resulted in low cumulative mortality (i.e. 0-35%), even after exposure to an unnaturally high concentration of bacterial cells (i.e. > 107 cells/ml). However, scale loss and frayed fins were observed in dead fish. In silico whole-genome analysis detected various genes associated with iron acquisition, encoding of the type IX secretion system and cargo proteins, resistance to tetracycline and fluoroquinolones and stress responses. These data represent an important milestone towards a better understanding on the genomic repertoire of T. piscium.


Subject(s)
Fish Diseases , Oncorhynchus kisutch , Oncorhynchus mykiss , Tenacibaculum , Animals , Chile/epidemiology , Fatty Acids , Fish Diseases/epidemiology , Fish Diseases/microbiology , Fluoroquinolones , Genomics , Iron , Tenacibaculum/genetics , Tetracyclines , Virulence/genetics
18.
Adv Ther ; 39(8): 3735-3748, 2022 08.
Article in English | MEDLINE | ID: mdl-35752730

ABSTRACT

INTRODUCTION: Insulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec (a basal insulin) and insulin aspart (a prandial insulin). The aim of this study was to investigate clinical outcomes in people with type 2 diabetes (T2D) after initiating IDegAsp treatment in a real-world setting. METHODS: This 26-week, open-label, non-interventional study was conducted in Australia, India, Malaysia, Philippines, Saudi Arabia, and South Africa. Data were obtained from 1102 adults with T2D initiating or switching to IDegAsp from antidiabetic treatments (including oral antidiabetic drugs, basal insulin, basal-bolus insulin, premix insulin, and glucagon-like peptide 1 receptor agonist) per local clinical practice. RESULTS: Compared with baseline, there was significant improvement in HbA1c at end of study (EOS, first visit within weeks 26-36; estimated change - 1.4% [95% CI - 1.51; - 1.29]; P < 0.0001 [primary outcome]). From baseline to EOS, there were significant reductions in fasting plasma glucose (- 2.7 mmol/L [95% CI - 2.98; - 2.46]; P < 0.0001), body weight (- 1.0 kg [95% CI - 1.51; - 0.52]; P < 0.0001), and basal insulin dose in insulin-experienced participants (- 2.3 units [95% CI - 3.51; - 1.01]; P < 0.001). The incidence rates of non-severe (overall and nocturnal) and severe hypoglycaemia decreased significantly (P < 0.001) between the period before baseline and before EOS. CONCLUSION: In adults with T2D, initiating or switching to IDegAsp from previous antidiabetic treatment was associated with improved glycaemic control, lower basal insulin dose (in insulin-experienced participants), and lower rates of hypoglycaemia. TRIAL REGISTRATION: Clinical trial registration NCT04042441.


Subject(s)
Diabetes Mellitus, Type 2 , Hypoglycemia , Adult , Blood Glucose , Diabetes Mellitus, Type 2/drug therapy , Drug Combinations , Glycated Hemoglobin/analysis , Humans , Hypoglycemia/chemically induced , Hypoglycemia/drug therapy , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Insulin Aspart/therapeutic use , Insulin, Long-Acting , Prospective Studies
19.
BMC Cancer ; 22(1): 246, 2022 Mar 05.
Article in English | MEDLINE | ID: mdl-35247994

ABSTRACT

BACKGROUND: The increasing role of exercise training in cancer care is built on evidence that exercise can reduce side effects of treatment, improve physical functioning and quality of life. We and others have shown in mouse tumor models, that exercise leads to an adrenalin-mediated increased influx of T and NK cells into the tumor, altering the tumor microenvironment (TME) and leading to reduced tumor growth. These data suggest that exercise could improve immune responses against cancer cells by increase immune cell infiltration to the tumor and potentially having an impact on disease progression. Additionally, there are data to suggest that infiltration of T and NK cells into the TME is correlates with response to immune checkpoint inhibitors in patients. We have therefore initiated the clinical trial HI AIM, to investigate if high intensity exercise can mobilize and increase infiltration of immune cells in the TME in patients with lung cancer. METHODS: HI AIM (NCT04263467) is a randomized controlled trial (70 patients, 1:1) for patients with non-small cell lung cancer. Patients in the treatment arm, receive an exercise-intervention consisting of supervised and group-based exercise training, comprising primarily intermediate to high intensity interval training three times per week over 6 weeks. All patients will also receive standard oncological treatments; checkpoint inhibitors, checkpoint inhibitors combined with chemotherapy or oncological surveillance. Blood samples and biopsies (ultrasound guided), harvested before, during and after the 6-week training program, will form basis for immunological measurements of an array of immune cells and markers. Primary outcome is circulating NK cells. Secondary outcome is other circulating immune cells, infiltration of immune cells in tumor, inflammatory markers, aerobic capacity measured by VO2 max test, physical activity levels and quality of life measured by questionnaires, and clinical outcomes. DISCUSSION: To our knowledge, HI AIM is the first project to combine supervised and monitored exercise in patients with lung cancer, with rigorous analyses of immune and cancer cell markers over the course of the trial. Data from the trial can potentially support exercise as a tool to mobilize cells of the immune system, which in turn could potentiate the effect of immunotherapy. TRIAL REGISTRATION: The study was prospectively registered at ClinicalTrials.gov on February 10th 2020, ID: NCT04263467. https://clinicaltrials.gov/ct2/show/NCT04263467.


Subject(s)
Carcinoma, Non-Small-Cell Lung/therapy , Exercise/immunology , High-Intensity Interval Training/methods , Lung Neoplasms/therapy , Lymphocytes/immunology , Adult , Biomarkers, Tumor/blood , Carcinoma, Non-Small-Cell Lung/immunology , Female , Humans , Killer Cells, Natural/immunology , Lung Neoplasms/immunology , Male , Prospective Studies , Randomized Controlled Trials as Topic , T-Lymphocytes/immunology , Treatment Outcome , Tumor Microenvironment/immunology
20.
Microbiol Resour Announc ; 11(4): e0124921, 2022 Apr 21.
Article in English | MEDLINE | ID: mdl-35289652

ABSTRACT

Draft genome sequences of 23 Tenacibaculum sp. strains that were isolated from Cyclopterus lumpus (lumpfish) were investigated to elucidate possible routes of transmission between Salmo salar (Atlantic salmon) and lumpfish.

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