Therapy For People Research Articles

Closed-Loop Insulin Therapy for People With Type 2 Diabetes Treated With an Insulin Pump: A 12-Week Multicenter, Open-Label Randomized, Controlled, Crossover Trial.

Continuous glucose monitoring (CGM) combined with continuous subcutaneous insulin infusion (CSII) achieves better glycemic control than multi-injection therapy in people with type 2 diabetes. The effectiveness of closed-loop therapy needs to be further evaluated in this population. The study objective was to measure the impact of a hybrid closed-loop device (DBLG1) compared with CSII + CGM on glycemic control in people with type 2 diabetes previously treated with CSII. The randomized, controlled, crossover, two-period, open-label, and multicenter study was conducted from August 2022 to July 2023 in 17 individuals (9 to receive 6 weeks of CSII + CGM first and 8 to receive 6 weeks of closed-loop therapy first). The primary end point was the percentage time in range (TIR: 70-180 mg/dL). Secondary outcomes were other CGM-glucose metrics, physical activity, and sleep objectively measured using 1-week actimetry. Data were analyzed using a modified intention-to-treat approach. Mean age was 63 (SD 9) years and 35% were women. Mean HbA1c at inclusion was 7.9% (SD 0.9). TIR increased to 76.0% (interquartile range 69.0-84.0) during the closed-loop condition vs. 61.0% (interquartile range 55.0-70.0) during the CSII + CGM condition; mean difference was 15.0 percentage points (interquartile range 8.0-22.0; P < 0.001). Analyses of secondary end points showed a decrease in time above range, in glucose management indicator, in glucose variability, and an increase in daily insulin dose. Actimetric sleep analysis showed an improvement in sleep fragmentation during closed-loop treatment. Closed-loop therapy improved glycemic control more than did CSII + CGM in people with type 2 diabetes.

“Evaluation of ELITE InGenius® integrative system for detection, quantification and monitoring of HIV-1 RNA in Cerebrospinal Fluid.”

IntroductionHuman Immunodeficiency virus (HIV) is effectively suppressed in the blood by the Antiretroviral Therapy in people living with HIV, but in rare cases can be present in some tissues and body fluids. In recent years, integrated systems were validated for detecting HIV-1 in plasma or serum. but not in cerebrospinal fluid (CSF). We evaluated the performance of ELITE InGenius® in comparison with the cobas® in this area. MethodsTo test the diagnostic accuracy of the HIV-1 ELITe MGB® kit on CSF samples, we tested CSF samples previously characterised with the cobras® HIV1 test. Archived CSF samples were also spiked with serial dilutions of the 4th WHO International Standard for HIV-1 NAT and assays and tested to assess the repeatability and reproducibility of the ELITechGroup assay. ResultsThe HIV-1 ELITe MGB® Kit confirmed all the HIV-1 negative CSF samples from patients HIV positive in plasma and from non-HIV1 patients. All the CSF samples that were HIV-1 positive by the cobas®, were confirmed positive by the ELITe InGenius®. Concordance across the methods was also observed when processing the CSF dilutions spiked at medium-low titre, mimicking HIV-1 low-load infections. ConclusionsThe two systems were equivalent in the detection and quantification of HIV-1 RNA in CSF samples.

Long-term effectiveness, safety, and tolerability of doravirine in antiretroviral-experienced people with HIV in real life.

Real-life data on doravirine (DOR) in different drug combinations are limited. We evaluated the effectiveness of DOR plus two nucleos(t)ide reverse transcriptase inhibitors (NRTI), mainly abacavir/lamivudine, and dual therapies in people with HIV (PWH), mostly virologically suppressed. Ambispective observational study that enrolled adults PWH who initiated a DOR-based regimen from September 2020 to February 2022 at a referral center in Spain. Participants were grouped as follows: A, received DOR plus two NRTI; B, dual therapy (DT) with DOR plus dolutegravir (DTG) or darunavir/cobicistat (DRVc); C, DOR plus ≥two antiretroviral drugs. The primary endpoints were treatment effectiveness at week 48 by intention-to-treat (ITT) and per-protocol analysis (OT). A cohort of 187 participants, 91% virologically suppressed, were analyzed after a median follow-up of 112 weeks (80-136). Group A received DOR plus abacavir/lamivudine (ABV/3TC) (n = 109) or tenofovir/emtricitabine (TFV/3TC) (n = 45). At week 48, the effectiveness of DOR plus ABV/3TC by ITT was 90.8% (CI95, 88.0-93.6), better than with TFV/FTC [73.3% (66.7-79.9); P = 0.003]. Only one virologic failure was observed. Mild adverse effects were the cause of treatment discontinuation in 7.8%, followed by switching to a single-tablet regimen. In group B, the effectiveness by ITT was 92.9% (CI95, 88.0-97.8) at week 48. No adverse effects or virologic failure were registered in this group. DOR plus two NRTI or DT have long-term effectiveness and safety as a switching option for PWH, mostly virologically suppressed. The DOR plus ABV/3TC combination has shown even better effectiveness than TFV/FTC.IMPORTANCEDOR-based regimens have shown long-term effectiveness and safety in PWH, mostly virologically suppressed. The combination of DOR plus ABV/3TC has shown even better safety and effectiveness than TFV/FTC. DOR plus two NRTI offers cost benefits compared to other regimens.

Study protocol for the MIND-PD study: a randomized controlled trial to investigate clinical and biological effects of mindfulness-based cognitive therapy in people with Parkinson’s disease

BackgroundPeople with Parkinson’s disease (PD) are very sensitive to the effects of stress. The prevalence of stress-related neuropsychiatric symptoms is high, and acute stress worsens motor symptoms. Animal studies suggest that chronic stress may accelerate disease progression, but evidence for this in humans is lacking. Mindfulness-based interventions (MBIs) train participants to focus on the present moment, on purpose and without judgement. Previous studies suggest that MBIs may alleviate stress and reduce depression and anxiety in PD. We aim to demonstrate the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) as a non-pharmacologic treatment strategy for neuropsychiatric (and motor) symptoms in PD, and to identify the mechanisms underlying stress and stress reduction in PD.MethodsIn a prospective randomized controlled trial (RCT), we investigate whether 8 weeks of MBCT, as compared to care as usual, can reduce symptoms of anxiety and depression in people with PD. We aim to include 124 PD patients, who experience mild-moderate symptoms of anxiety and depression, are eligible for magnetic resonance imaging (MRI) and naïve to mindfulness, and who have a disease duration ≤ 10 years. Every participant is followed for 12 months. Clinical and biochemical assessments take place at baseline (T0), after 2 months (T1), and after 12 months (T2); MRI assessments take place at T0 and T2. Our primary outcome is the total score on the Hospital Anxiety and Depression Scale (HADS) at T1, while correcting for the HADS score at T0, age, and gender. Beyond testing the effects of MBCT on symptoms of anxiety and depression in PD, we explore whether MBCT: (1) has an effect on motor symptom severity, (2) influences cerebral and biochemical markers of stress, and (3) leads to a change in biomarkers of PD progression.DiscussionMIND-PD is one of the first RCTs with a 1-year follow-up to investigate the effects of MBCT on symptoms of anxiety and depression in PD, and to explore possible mechanisms underlying stress and stress reduction in PD. Insight into these mechanisms can pave the way to new treatment methods in the future.Trial registrationClinicalTrials.gov, NCT05779137. Registered on 12 January 2023.

Physical Therapy and Aminopyridine for Downbeat Nystagmus Syndrome: A Case Report.

Individuals with downbeat nystagmus (DBN) syndrome present with DBN, dizziness, blurred vision, and unsteady gait. Pharmacological intervention with 4-aminopyridine (4-AP) may be effective in improving oculomotor function, but there is minimal evidence to date that it improves gait. This suggests the possible benefit of combining pharmacotherapy with physical therapy to maximize outcomes. This case report documents improvements in gait and balance after physical therapy and aminopyridine (AP) in an individual with DBN syndrome. The patient was a 70-year-old man with a 4-year history of worsening dizziness and imbalance, diagnosed with DBN syndrome. He demonstrated impaired oculomotor function, dizziness, and imbalance, which resulted in falls and limited community ambulation. The patient completed a customized, tapered course of physical therapy over 6months. Outcome measures included the 10-meter walk test, the Timed Up and Go (TUG), the Dynamic Gait Index (DGI), and the modified clinical test of sensory integration and balance. Improvements exceeding minimal detectable change were demonstrated on the TUG and the DGI. Gait speed on the 10-meter walk test did not change significantly, but the patient was able to use a cane to ambulate in the community and reported no further falls. Controlled studies are needed to explore the potential for AP to augment physical therapy in people with DBN syndrome. Physical therapists are encouraged to communicate with referring medical providers about the use of AP as pharmacotherapy along with physical therapy for individuals with DBN syndrome.

Are adjunct treatments effective in improving pain and function when added to exercise therapy in people with patellofemoral pain? A systematic review with meta-analysis and appraisal of the quality of interventions

ObjectiveTo compare the effectiveness of adjunct treatments combined with exercise to exercise alone in people with patellofemoral pain (PFP) and explore the quality of intervention descriptions in randomised controlled trials...

SAT-379 Immune checkpoint proteins are associated with persistently elevated liver stiffness after successful HCV therapy in people with HIV

SAT-379 Immune checkpoint proteins are associated with persistently elevated liver stiffness after successful HCV therapy in people with HIV

One-year effectiveness of long-term exercise therapy in people with axial spondyloarthritis and severe functional limitations

Abstract Objective To evaluate the effectiveness of long-term, personalized, supervised exercise therapy on functional ability compared with usual care in people with axial spondyloarthritis (axSpA) and severe functional limitations. Methods Participants were randomly 1:1 assigned to the intervention [maximal 64 sessions, with 14 additional optional sessions of supervised active exercise therapy (e.g. aerobic and muscle strengthening) with individualized goal-setting, education and self-management regarding physical activity] or usual care (care determined by clinician(s) and participants themselves). Primary endpoint was the change in the Patient-Specific Complaints activity ranked 1 [PSC1 (0–10)] at 52 weeks. Secondary endpoints were the PSC activities ranked 2 and 3, the Bath Ankylosing Spondylitis Functional Index, 6-min walk test, Patient Reported Outcome Measurement Information System-Physical Function-10 and the Short Form-36 Physical and Mental Component Summary Score (SF-36 PCS and MCS). Statistical comparisons comprised independent student t-tests and linear mixed models, based on intention-to-treat. Results 214 participants [49% female, age 52 (s.d. 12) years], were randomized to the intervention (n = 110) or usual care (n = 104) group. In the intervention group 93% started treatment, using on average 40.5 sessions (s.d. 15.1). At 52 weeks, the difference in change in PSC1 between groups favoured the intervention group [mean difference (95% CI); −1.8 (−2.4 to −1.2)]. Additionally, all secondary outcomes, except the SF-36 MSC, showed significantly greater improvements in the intervention group with effect sizes ranging from 0.4 to 0.7. Conclusion Long-term, supervised exercise therapy proved more effective than usual care in improving functional disability and physical quality of life in people with axSpA and severe functional limitations. Trial registration Netherlands Trial Register NL8238, included in the International Clinical Trial Registry Platform (ICTRP) (https://trialsearch.who.int/Trial2.aspx?TrialID=NL8238).

Engaging self-care for people with atrial fibrillation: a commentary on self-care behaviours in oral anticoagulant therapy in people with non-valvular atrial fibrillation.

Engaging self-care for people with atrial fibrillation: a commentary on self-care behaviours in oral anticoagulant therapy in people with non-valvular atrial fibrillation.

P046 Lenticlair™-ON: An extension trial examining long-term safety and efficacy outcomes associated with an inhaled F/HN-pseudotyped lentiviral vector for CF gene therapy in people with cystic fibrosis

P046 Lenticlair™-ON: An extension trial examining long-term safety and efficacy outcomes associated with an inhaled F/HN-pseudotyped lentiviral vector for CF gene therapy in people with cystic fibrosis

P059 Associations between olfactory dysfunction, eating-related quality of life, chronic rhinosinusitis, and highly effective modulator therapy in people with cystic fibrosis

P059 Associations between olfactory dysfunction, eating-related quality of life, chronic rhinosinusitis, and highly effective modulator therapy in people with cystic fibrosis

P045 Lenticlair™ 1: A phase 1/2 trial evaluating the safety, tolerability and efficacy of an inhaled F/HN-pseudotyped lentiviral vector for CF gene therapy in people with CF ineligible for CFTR modulators

P045 Lenticlair™ 1: A phase 1/2 trial evaluating the safety, tolerability and efficacy of an inhaled F/HN-pseudotyped lentiviral vector for CF gene therapy in people with CF ineligible for CFTR modulators

EPS4.08 Perception of symptom changes, treatment burden and quality of life are associated with discontinuation of supportive therapy in people with CF treated with elexacaftor/tezacaftor/ivacaftor

EPS4.08 Perception of symptom changes, treatment burden and quality of life are associated with discontinuation of supportive therapy in people with CF treated with elexacaftor/tezacaftor/ivacaftor

Timing-dependent synergies between motor cortex and posterior spinal stimulation in humans.

Volitional movement requires descending input from the motor cortex and sensory feedback through the spinal cord. We previously developed a paired brain and spinal electrical stimulation approach in rats that relies on convergence of the descending motor and spinal sensory stimuli in the cervical cord. This approach strengthened sensorimotor circuits and improved volitional movement through associative plasticity. In humans, it is not known whether posterior epidural spinal cord stimulation targeted at the sensorimotor interface or anterior epidural spinal cord stimulation targeted within the motor system is effective at facilitating brain evoked responses. In 59 individuals undergoing elective cervical spine decompression surgery, the motor cortex was stimulated with scalp electrodes and the spinal cord was stimulated with epidural electrodes, with muscle responses being recorded in arm and leg muscles. Spinal electrodes were placed either posteriorly or anteriorly, and the interval between cortex and spinal cord stimulation was varied. Pairing stimulation between the motor cortex and spinal sensory (posterior) but not spinal motor (anterior) stimulation produced motor evoked potentials that were over five times larger than brain stimulation alone. This strong augmentation occurred only when descending motor and spinal afferent stimuli were timed to converge in the spinal cord. Paired stimulation also increased the selectivity of muscle responses relative to unpaired brain or spinal cord stimulation. Finally, clinical signs suggest that facilitation was observed in both injured and uninjured segments of the spinal cord. The large effect size of this paired stimulation makes it a promising candidate for therapeutic neuromodulation. KEY POINTS: Pairs of stimuli designed to alter nervous system function typically target the motor system, or one targets the sensory system and the other targets the motor system for convergence in cortex. In humans undergoing clinically indicated surgery, we tested paired brain and spinal cord stimulation that we developed in rats aiming to target sensorimotor convergence in the cervical cord. Arm and hand muscle responses to paired sensorimotor stimulation were more than five times larger than brain or spinal cord stimulation alone when applied to the posterior but not anterior spinal cord. Arm and hand muscle responses to paired stimulation were more selective for targeted muscles than the brain- or spinal-only conditions, especially at latencies that produced the strongest effects of paired stimulation. Measures of clinical evidence of compression were only weakly related to the paired stimulation effect, suggesting that it could be applied as therapy in people affected by disorders of the central nervous system.

Relationship between Contingent Negative Variation and afterimage duration in migraine patients.

Abnormalities in electrocortical parameters and persistence of afterimage after visual stimulation are known to occur in migraine patients. The results of studies on Contingent Negative Variation (CNV) and afterimage persistence in migraine patients suggest a link between these two phenomena and a connection to the pathomechanism of migraine. To date, no studies have investigated both afterimage duration and CNV parameters in the same subjects. The aim of this study was to investigate the relationship between the early component of CNV (iCNV) and the duration of the afterimage in migraine patients. Sixty seven migraine patients from the headache center of the University of Rostock Medical Center were examined for iCNV amplitude, iCNV habituation and afterimage duration. The subjects also completed questionnaires developed for this study and the MIDAS (Migraine Disability Assessment) questionnaire. Associations were found between iCNV amplitude and afterimage duration and between habituation capacity and afterimage duration. A deficit in habituation capacity correlated with a significantly prolonged afterimage duration. Increased iCNV amplitude and prolonged afterimage duration were also significantly correlated. Conclusions about the pathophysiology of migraine can be drawn from the results of this study. The results support the hypothesis of cortical hyperexcitability as a consequence of a low pre-activation level, which may be a possible contributory cause of migraine. Furthermore, they allow assessment of whether the afterimage examination, which is easier and quicker to perform than the CNV examination, can be used as a diagnostic tool or as a parameter to monitor the course of therapy in people with migraine.

Cardiovascular health and cancer risk associated with plant based diets: An umbrella review.

Cardiovascular diseases (CVDs) and cancer are the two main leading causes of death and disability worldwide. Suboptimal diet, poor in vegetables, fruits, legumes and whole grain, and rich in processed and red meat, refined grains, and added sugars, is a primary modifiable risk factor. Based on health, economic and ethical concerns, plant-based diets have progressively widespread worldwide. This umbrella review aims at assessing the impact of animal-free and animal-products-free diets (A/APFDs) on the risk factors associated with the development of cardiometabolic diseases, cancer and their related mortalities. PubMed and Scopus were searched for reviews, systematic reviews, and meta-analyses published from 1st January 2000 to 31st June 2023, written in English and involving human subjects of all ages. Primary studies and reviews/meta-analyses based on interventional trials which used A/APFDs as a therapy for people with metabolic diseases were excluded. The umbrella review approach was applied for data extraction and analysis. The revised AMSTAR-R 11-item tool was applied to assess the quality of reviews/meta-analyses. Overall, vegetarian and vegan diets are significantly associated with better lipid profile, glycemic control, body weight/BMI, inflammation, and lower risk of ischemic heart disease and cancer. Vegetarian diet is also associated with lower mortality from CVDs. On the other hand, no difference in the risk of developing gestational diabetes and hypertension were reported in pregnant women following vegetarian diets. Study quality was average. A key limitation is represented by the high heterogeneity of the study population in terms of sample size, demography, geographical origin, dietary patterns, and other lifestyle confounders. Plant-based diets appear beneficial in reducing cardiometabolic risk factors, as well as CVDs, cancer risk and mortality. However, caution should be paid before broadly suggesting the adoption of A/AFPDs since the strength-of-evidence of study results is significantly limited by the large study heterogeneity alongside the potential risks associated with potentially restrictive regimens.

Intervention of computer-assisted cognitive training combined with occupational therapy in people with mild cognitive impairment: a randomized controlled trial.

Investigate the impact of combined computerized cognitive training and occupational therapy on individuals with mild cognitive impairment (MCI). We randomly assigned 118 MCI patients into two groups: a combined intervention group (n = 37) and a control group (n = 81), the latter receiving standard nursing care. The intervention group additionally underwent 12 weeks of computerized cognitive training and occupational therapy. Blind assessors evaluated cognitive performance, anxiety, depression, and daily living activities before the intervention, post-intervention, and at a 3-month follow-up. Repeated-measures analysis of variance showed that the sMoCA scores, HAMA scores, and ADL scores of the experimental group at T2 (post-intervention) and T3 (3-month follow-up) were higher than those of the control group, and the difference was statistically significant (p < 0.001, p < 0.001, p = 0.026). Computerized cognitive training combined with occupational therapy can improve patients' cognitive status, enhance their compliance with continuing care, and maintain their anxiety and self-care ability at a stable level. https://www.chictr.org.cn/index.html, identifier ChiCTR2200065014.

Semaglutide therapy in people with type 2 diabetes and obesity: efficacy on glycated hemoglobin and weight loss

Semaglutide therapy in people with type 2 diabetes and obesity: efficacy on glycated hemoglobin and weight loss

Renal safety of tenofovir alafenamide-based antiretroviral therapy in people with HIV: A mini-review.

Antiretroviral therapy (ART) has significantly enhanced the outlook for people with HIV(PWH), yet certain ART medications can adversely affect the renal function of these patients. Of particular concern is the nephrotoxicity associated with tenofovir disoproxil fumarate (TDF). Compared to TDF, tenofovir alafenamide (TAF), another prodrug of tenofovir (TFV), results in lower TFV plasma levels, thereby alleviating the TFV-associated mitochondrial toxicity on proximal renal tubular cells. Currently, numerous clinical trials and real-world studies have demonstrated the favorable renal safety profile of ART regimens incorporating TAF for PWH. This paper seeks to consolidate the available evidence regarding the renal safety of TAF-based regimens in PWH, encompassing both the general PWH and those with renal impairment or predisposing factors, in order to offer recommendations and insights for TAF clinical application.

P064 It’s a long time to wait: exploring the support needs of people with rheumatoid arthritis starting methotrexate

Abstract Background/Aims Methotrexate (MTX) is recommended as initial Disease Modifying Anti-Rheumatic Drug (DMARD) therapy for people with Rheumatoid Arthritis (RA) but often takes several months to become effective. Little is known about the support needs of people with RA whilst MTX takes effect. Methods 76 adults with RA referred for MTX counselling attending two rheumatology units in the West Midlands were invited to take part in qualitative semi-structured interviews (either by phone or video). Research partners with RA helped to develop interview topic guides. Interviews were digitally recorded, transcribed and analysed using reflexive thematic analysis. Results 19 participants, (11 male, 8 Female, White British, age 45-75 years, disease duration (6 weeks - 35 years) took part in telephone (n = 17) and video (n = 2) interviews (duration 34-82 minutes). Three themes were identified; Concerns regarding time to effect, Learning to cope with the impact of RA, A need for support to self-manage RA. Concerns regarding time to effect: most people expressed concerns about coping with active symptoms of RA whilst waiting for MTX to take effect. Few recalled receiving information about nonpharmacological symptom management. Many experienced initial benefit following intramuscular bridging steroids, often wearing off as MTX commenced, and did not recall plans for further steroids. Conflicting advice about the use of analgesia and non-steroidal anti-inflammatory drugs (NSAIDs) to manage pain and joint stiffness sometimes created confusion. A few recollected advice to stop taking analgesia or NSAIDs when starting MTX. Several reported difficulties accessing help with symptom control and obtaining analgesia and NSAIDs in primary care. Learning to cope with the impact of RA: Participants reported limitations to physical function, restricting their independence with daily living activities with an impact on social, relational and work roles. Most, however, reported finding ways to manage these limitations. Several described negative impacts on mental health. A need for support to self-manage RA: Most identified unmet needs regarding self-management whilst waiting for MTX to take effect. Few recalled receiving education or support regarding self-management for RA. Some received leaflets regarding managing flares of RA that were seen to provide practical advice and reassurance. Several reported not reading leaflets and coping with flares without education or support. Positive support was sometimes received from relatives and others with RA, whereas few used the internet to find additional help. Rheumatology advice lines were often perceived as a useful source of support, but some people were reticent to seek help and others had concerns about delayed responses. Conclusion Many people with RA report unmet needs to support self-management whilst waiting for MTX to take effect. Appropriate signposting and referral to support provided by RA patient associations may offer useful solutions for some. Disclosure S.J. Logan: None. S. Hider: None. J. Green: None. S. Ryan: None.