Safety of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute Moderate-to-Severe Pain: Pooled Analysis of Three Phase 3 Randomized Trials.

Introduction: Multi-modal analgesia is desirable for the management of acute pain since it can provide effective pain relief at lower doses, thereby aiding tolerability. Co-crystal of tramadol-celecoxib (CTC) provides effective analgesia in models of acute pain. Co-crystallization can alter the pharmacokinetics of individual components, potentially improving tolerability.

Efficacy of Co-Crystal of Tramadol-Celecoxib (CTC) in Patients with Acute Moderate-to-Severe Pain: A Pooled Analysis of Data from Two Phase 3 Randomized Clinical Trials.

Background And Objectives: New acute pain medications are needed that provide effective analgesia while minimizing side effects and opioid exposure. Clinical trials of co-crystal of tramadol-celecoxib (CTC) have demonstrated an improved benefit/risk profile versus tramadol or celecoxib alone. We pooled data from two phase 3 clinical trials to evaluate the efficacy of CTC 200 mg twice daily (BID) in acute moderate-to-severe pain.

Co-designing adult weight management services: a qualitative study exploring barriers, facilitators, and considerations for future commissioning.

Background: Weight management services have not always benefitted everyone equally. People who live in more deprived areas, racially minoritised communities, those with complex additional needs (e.g.

Co-crystal of tramadol-celecoxib (CTC) for acute moderate-to-severe pain.

Objective: This narrative review aims to provide a clinical perspective on the potential role of co-crystal of tramadol-celecoxib (CTC) in the management of acute moderate-to-severe pain by synthesizing the available preclinical and clinical data, with emphasis on phase 3 trials.

Methods: A non-systematic literature review was performed using a targeted PubMed search for articles published between January 1, 2000, and May 2, 2023; all publication types were permitted, and selected articles were limited to those published in English. Search results were manually reviewed to identify references based on their preclinical and clinical relevance to CTC and management of acute moderate-to-severe pain.

Co-crystal of Tramadol-Celecoxib Versus Tramadol or Placebo for Acute Moderate-to-Severe Pain After Oral Surgery: Randomized, Double-Blind, Phase 3 Trial (STARDOM1).

Introduction: Co-crystal of tramadol-celecoxib (CTC) is the first analgesic co-crystal for acute pain. This completed phase 3 multicenter, double-blind trial assessed the efficacy and safety/tolerability of CTC in comparison with that of tramadol in the setting of moderate-to-severe pain up to 72 h after elective third molar extraction requiring bone removal.

Methods: Adults (n = 726) were assigned randomly to five groups (2:2:2:2:1): orally administered twice-daily CTC 100 mg (44 mg rac-tramadol hydrochloride/56 mg celecoxib; n = 164), 150 mg (66/84 mg; n = 160) or 200 mg (88/112 mg; n = 160); tramadol 100 mg four times daily (n = 159); or placebo four times daily (n = 83).

The accumulation and growth of Pseudomonas aeruginosa on surfaces is modulated by surface mechanics via cyclic-di-GMP signaling.

Attachment of bacteria onto a surface, consequent signaling, and accumulation and growth of the surface-bound bacterial population are key initial steps in the formation of pathogenic biofilms. While recent reports have hinted that surface mechanics may affect the accumulation of bacteria on that surface, the processes that underlie bacterial perception of surface mechanics and modulation of accumulation in response to surface mechanics remain largely unknown. We use thin and thick hydrogels coated on glass to create composite materials with different mechanics (higher elasticity for thin composites; lower elasticity for thick composites) but with the same surface adhesivity and chemistry.

Protocol to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC UK): a multicentre cluster randomised controlled trial.

Unlabelled: Background One in seven UK children have obesity when starting school, with higher prevalence associated with deprivation. Most pre-school children do not meet UK recommendations for physical activity and nutrition. Formal childcare settings provide opportunities to deliver interventions to improve nutritional quality and physical activity to the majority of 3-4-year-olds.

Bacterial mechanosensing of surface stiffness promotes signaling and growth leading to biofilm formation by .

The attachment of bacteria onto a surface, consequent signaling, and the accumulation and growth of the surface-bound bacterial population are key initial steps in the formation of pathogenic biofilms. While recent reports have hinted that the stiffness of a surface may affect the accumulation of bacteria on that surface, the processes that underlie bacterial perception of and response to surface stiffness are unknown. Furthermore, whether, and how, the surface stiffness impacts biofilm development, after initial accumulation, is not known.

A qualitative study of parental strategies to enable pre-school children's outdoor and nature experiences during COVID-19 restrictions.

Outdoor and nature experiences including play have been shown to be beneficial for children's physical, cognitive, social and emotional development. Parents/carers play an important role in encouraging or impeding their child's access to the outdoor environment and participation in outdoor play. The COVID-19 pandemic and associated restrictions on free movement and social interactions placed an unprecedented pressure on families to manage the drastic change in their daily routines.

Efficacy and safety of co-crystal of tramadol-celecoxib (CTC) in acute moderate-to-severe pain after abdominal hysterectomy: A randomized, double-blind, phase 3 trial (STARDOM2).

Background: STARDOM2 is a randomized, double-blind, phase 3 trial evaluating the efficacy and safety of co-crystal of tramadol-celecoxib (CTC)-a first-in-class analgesic co-crystal comprising racemic tramadol hydrochloride and celecoxib in a supramolecular network that modifies their pharmacokinetic properties-for the management of acute postoperative pain (NCT03062644; EudraCT:2016-000593-38).

Methods: Patients with moderate-to-severe pain following abdominal hysterectomy were randomized 2:2:2:2:2:1 to oral CTC 100 mg (rac-tramadol hydrochloride 44 mg/celecoxib 56 mg) twice daily (BID); CTC 150 mg (66/84 mg) BID; CTC 200 mg (88/112 mg) BID; immediate-release tramadol 100 mg four times daily (QID); celecoxib 100 mg BID; or placebo, for 5 days. The primary endpoint was the sum of pain intensity differences over 0-4 h (SPID ).

Parents' perceptions of children's emotional well-being during spring 2020 COVID-19 restrictions: A qualitative study with parents of young children in England.

Background: During COVID-19 restrictions in England in spring 2020, early years settings for young children were closed to all but a small percentage of families, social contact was limited and play areas in parks were closed. Concerns were raised about the impact of these restrictions on young children's emotional well-being. The aim of this study was to explore parents' perceptions of young children's emotional well-being during these COVID-19 restrictions.

Individual-, family- and school-based interventions to prevent multiple risk behaviours relating to alcohol, tobacco and drug use in young people aged 8-25 years: a systematic review and meta-analysis.

Background: Engagement in multiple substance use risk behaviours such as tobacco smoking, alcohol and drug use during adolescence can result in adverse health and social outcomes. The impact of interventions that address multiple substance use risk behaviours, and the differential impact of universal versus targeted approaches, is unclear given findings from systematic reviews have been mixed. Our objective was to assess effects of interventions targeting multiple substance use behaviours in adolescents.

Links between obesity, weight stigma and learning in adolescence: a qualitative study.

Background: Educational attainment is a key social determinant of health. Health and education are linked by multiple pathways, many of which are not well understood. One such pathway is the association between being above a healthy weight and lower academic achievement.

Impact of COVID-19 restrictions on preschool children's eating, activity and sleep behaviours: a qualitative study.

Objectives: In spring 2020, the first COVID-19 national lockdown placed unprecedented restrictions on the behaviour and movements of the UK population. Citizens were ordered to 'stay at home', only allowed to leave their houses to buy essential supplies, attend medical appointments or exercise once a day. We explored how lockdown and its subsequent easing changed young children's everyday activities, eating and sleep habits to gain insight into the impact for health and well-being.

Central sensitisation in chronic fatigue syndrome and fibromyalgia; a case control study.

Introduction: Chronic fatigue syndrome (CFS) and fibromyalgia (FM) are both complex conditions that are challenging to treat. This may be related to an incomplete understanding of their pathophysiology, itself obfuscated by their heterogeneity. The symptomatic overlap between them and their common comorbidity suggests a shared vulnerability, which might be explained by central sensitisation.

Reducing COVID-19 risk in schools: a qualitative examination of secondary school staff and family views and concerns in the South West of England.

Objective: To investigate student, parent/carer and secondary school staff attitudes towards school COVID-19 mitigation measures.

Methods: Recruitment used school communication, community organisations and snowball sampling in South West England. Audio recorded online or phone individual/group semi-structured interviews were conducted in July-Septtember 2020 and lasted 30-60 min.

Orthognathic returns to theatre.

The objectives of this retrospective study were to determine the unexpected return-to-theatre rate for orthognathic surgery at James Cook University Hospital and describe the reasons for return. A total of 357 consecutive orthognathic cases under two consultants over a 13-year period were included. Patients who had an unexpected return to theatre were identified and their notes analysed for data including preoperative dentofacial discrepancy, surgical movement, and reason for return.

Subcutaneous tanezumab for osteoarthritis: Is the early improvement in pain and function meaningful and sustained?

Background: To evaluate if early improvements in pain and function with subcutaneous tanezumab are meaningful and sustained over 24 weeks.

Methods: Patients with moderate-to-severe osteoarthritis (hip or knee) in Europe and Japan were randomized to placebo, tanezumab 2.5 mg or tanezumab 5 mg (baseline, Week 8 and Week 16).

Feasibility of Videophone-Assisted Neuropsychological Testing For Intensive Care Unit Survivors.

Background: Most hospitals lack neuropsychologists, and this lack has hampered the conduct of large-scale, multicenter clinical trials to evaluate the effect of interventions on long-term cognition in patients in intensive care units (ICUs).

Objective: To evaluate the feasibility of videophone-assisted neuropsychological testing administered by using an inexpensive high-definition web camera and a laptop.

Methods: This prospective, single-center observational study, conducted at a tertiary care academic hospital, included ICU survivors aged 18 years or older.

CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa.

Background: South Africa is home to the world's largest antiretroviral therapy program but sustaining engagement along the HIV care continuum has proven challenging in the country and throughout the wider region. Population mobility is common in South Africa, but there are important research gaps in describing this mobility and its impact on engagement in HIV care. Postpartum women and their infants in South Africa are known to be at high risk of dropping out of HIV care after delivery and are frequently mobile.

Comparison of the piezoelectric cutter with a conventional cutting technique in orthognathic surgery.

The use of a piezoelectric cutter has been reported to improve outcomes in orthognathic surgery, particularly with regards to neurosensory disturbance of the inferior alveolar nerve. The aims of this retrospective longitudinal cohort study were to compare outcomes regarding neurosensory disturbance, and operating time. During two 15-month periods a single surgeon treated 24 consecutive patients with a conventional cutting technique and a further 24 consecutive patients with a piezoelectric cutter.

A randomized pilot study to investigate the effect of opioids on immunomarkers using gene expression profiling during surgery.

Endogenous opioid peptides and exogenous opioids modulate immune function, and animal and human studies have shown that some have a depressant immunomodulatory effect. This is potentially of high clinical significance, eg, in cancer patients and surgery. The primary objective of this pilot study was to evaluate the effect of morphine and oxycodone on immune pathways associated with immunosuppression in gynecological laparotomy patients.