13 results match your criteria: "Nordic Bioscience Clinical Development[Affiliation]"

Introduction: Christmas parties, a longstanding Danish tradition, became festive occasions in the 1960s. This study examines if healthcare professionals, especially doctors and nurses, have larger bladder capacities than the general population, as they often delay restroom breaks.

Methods: At the North Zealand University Hospital Department of Anesthesiology's 2023 Christmas party, participants delayed urination until a strong urge occurred.

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Article Synopsis
  • The study aimed to evaluate the safety, pharmacokinetics (how the drug moves through the body), and pharmacodynamics (the effects of the drug) of M6495, a new medication, in healthy volunteers and osteoarthritis patients.
  • Two randomized, placebo-controlled studies were conducted: one with healthy men and another with osteoarthritis patients, assessing various doses and administration methods of M6495 over a period of 106 days.
  • Results showed that M6495 was well tolerated with minimal adverse effects and significantly reduced biomarkers associated with osteoarthritis, indicating its potential as a disease-modifying treatment.
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Purpose: To investigate acute changes in biochemical markers of bone and cartilage turnover in response to moderate intensity exercise with and without joint impact in healthy human subjects.

Methods: A randomized, cross-over, exploratory, clinical study was conducted. Twenty healthy subjects with no history of joint trauma completed 30 min interventions of standardized moderate intensity cycling and running as well as a resting intervention 1 week apart.

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There is a need for antidiabetic agents successfully targeting insulin sensitivity and treating obesity control at the same time. The aim of this first-in-human study was (a) to evaluate safety and tolerability, (b) to evaluate pharmacokinetics and (c) to assess indications of receptor engagement of single ascending doses of KBP-042, a dual amylin and calcitonin receptor agonist (DACRA) that has shown promising preclinical data, with superior activity in terms of typical amylin-induced responses including reduction of food intake, weight loss and gluco-regulatory capacities. A randomised double-blind placebo-controlled single ascending dose study was performed with six dose levels of KBP-042 (5, 7.

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Co-bedding of Preterm Newborn Pigs Reduces Necrotizing Enterocolitis Incidence Independent of Vital Functions and Cortisol Levels.

Front Pediatr

April 2021

Comparative Pediatrics and Nutrition, Department of Veterinary and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

Preterm infants are born with immature organs, leading to morbidities such as necrotizing enterocolitis (NEC), a gut inflammatory disease associated with adverse feeding responses but also hemodynamic and respiratory instability. Skin-to-skin contact including "kangaroo care" may improve infant survival and health improved vital functions (e.g.

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Objective: To investigate acute changes in biochemical markers of cartilage turnover in response to moderate intensity exercise with and without joint impact in humans with knee osteoarthritis.

Design: We conducted a randomized, cross-over, exploratory clinical study. Twenty subjects with knee osteoarthritis (OA) were randomized, of which twenty completed 30 min of cycling and 15 completed 30 min of running on days 1 week apart.

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Purpose: Osteoarthritis Research Society International (OARSI) Expert Consensus Guidelines recommend topical non-steroidal anti-inflammatory drugs as first-line medications for osteoarthritis (OA) knee pain, but several voluminous daily applications are required to achieve efficacy. There is a need to develop new and improved topical analgesics with a faster onset, longer duration of action, and the requirement to apply less gel. This trial investigated the safety and efficacy of a new 3.

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Objectives: Clinical trials of new disease-modifying treatments for osteoarthritis should demonstrate a positive effect on a functional outcome or reduction in joint failure in order to be considered successful. Total joint replacement (TJR) surgery may be considered as joint failure, but great variation in the incidence of TJR complicates its use as a study endpoint. Factors predicting elevated risk of TJR could potentially be used to enrich such outcome-trials.

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Objective: To propose a standardized model for exercise-induced cartilage turnover and investigate residual levels and dynamics of biomarker serum ARGS (sARGS) in primary osteoarthritis (OA) patients and a supportive group of young healthy subjects.

Method: The trial is a randomized, cross-over, exploratory study with interventions of exercise and inactivity. 20 subjects with knee OA, as well as 20 young healthy subjects (mean age 25.

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Background: Excessive cartilage degradation is a known characteristic of osteoarthritis (OA). Biochemical markers, such as uCTX-II, have been shown to be associated with disease severity, yet the tissue origin of CTX-II has been disputed. This analysis investigates the association between OA knee joints at different radiographic stages and pain categories with levels of uCTX-II and biomarkers of bone resorption and formation.

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Article Synopsis
  • This randomized phase III study evaluated the effectiveness and safety of oral calcitonin (SMC021) in preventing fractures in postmenopausal women with osteoporosis, involving 4,665 participants over 36 months.
  • Despite SMC021 showing a modest increase in lumbar spine bone mineral density compared to placebo, it did not significantly prevent new vertebral, hip, or non-vertebral fractures.
  • Most adverse events were mild, with gastrointestinal issues being common and slightly higher dropout rates in the SMC021 group, leading to the conclusion that further development of the drug is not recommended due to inadequate efficacy.
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Purpose: Monitoring is a costly requirement when conducting clinical trials. New regulatory guidance encourages the industry to consider alternative monitoring methods to the traditional 100 % source data verification (SDV) approach. The purpose of this literature review is to provide an overview of publications on different monitoring methods and their impact on subject safety data, data integrity, and monitoring cost.

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Despite massive investments in the development of novel treatments for heterogeneous diseases such as COPD, the resources spent have only benefited a fraction of the population treated. Personalized health care to guide selection of a suitable patient population already in the clinical development of new compounds could offer a solution. This review discusses past successes and failures in drug development and biomarker research in COPD, describes research in COPD phenotypes and the required characteristics of a suitable biomarker for identifying patients at higher risk of progression, and examines the role of extracellular matrix proteins found to be upregulated in COPD.

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