Active Treatment Research Articles

SALIVARY SPECIFIC IgE TO D1 AND G6 IN PATIENTS WITH RHINITIS WITH OR WITHOUT S. AUREUS COLONIZATION

Globally, allergic rhinitis impacts roughly 25% of children and 40% of adults. Immunoglobulin E (IgE) plays a crucial part in allergic inflammation, with two sources: spontaneously produced IgE, and IgE stemming from reactions to environmental allergens. The damaging effects of S. aureus, as well as Staphylococcal enterotoxins (Ses), have been proven in numerous airway illnesses. As superantigens, Ses generate intense Th2 inflammation, with 70-80% of IgE being locally synthesized. Our study aimed to determine if any correlation existed between local and systemic specific IgE responses in rhinitis patients – both treated and untreated. Furthermore, we sought to pinpoint significant disparities in serum allergy-specific IgE levels between S. aureus positive and negative patients. Results: From 70 patients with a relevant rhinitis history spanning at least two years, we found that in our rhinitis cohort, 36 were sIgE-negative for d1 in blood samples but positive in saliva samples (χ2 = 19.76, α = 0.181), while 25 tested negative for g6 in blood samples but positive for g6 in saliva samples (χ2 = 6.89, α = 0.86). No significant difference emerged between serum allergy-specific IgE levels in S. aureus positive and negative rhinitis patients (χ2 = 0.38). Similar results were noted within the saliva samples. However, mucosal-specific IgE levels were lower among patients receiving active therapy (p < 0.001 for both d1 and g6). Conclusion: There is no correlation between mucosal-specific IgE levels and systemic-specific IgE levels or S. aureus carriers. We observed that salivary-specific IgE levels were lower in patients undergoing active treatment compared to untreated patients.

Clinical characteristics and influencing factors of hyperkyphosis in a Chinese Cohort with axial spondyloarthritis: a multicentre retrospective study

ObjectiveThis study aimed to investigate the clinical characteristics and influencing factors of axial spondyloarthritis (axSpA) hyperkyphosis in a Chinese cohort.MethodsA cross-sectional study was conducted on 607 patients with axSpA attending 12 hospitals across 11 centers from March 2022 to March 2024.Univariate and multivariate logistic regression analyses were used to explore the relevant influencing factors of hyperkyphosis. A nomogram model for impact factor visualisation and spearman correlation analysis was used to analyze the relationship between the influencing factors.ResultsMultivariable logistic regression revealed that male sex,disease duration,patient global assessment (PGA),erythrocyte sedimentation rate (ESR),the modified stoke spondylitis score（mSASSS）,pharmacological treatment, and ankylosing spondylitis disease activity score-c-reactive protein (ASDAS-CRP) significantly influenced hyperkyphosis(allP< 0.05).Based on the results of the multivariate regression analysis, we constructed a nomogram model for clinical evaluation with an AUC of 0.98 and an accuracy of 0.95.Spearman correlation analysis showed a positive correlation between the spondyloarthritis international society health index (ASAS-HI) and mSASSS (R=0.16,P<0.001), while pharmacological treatment was negatively correlated with disease activity and mSASSS (R=-0.24, -0.18,P<0.001).ConclusionControlling disease activity in the clinic is crucial. Active pharmacological treatment should be employed to delay radiological progression, enhance patients' ASAS-HI, psychological status, and physical functioning. Additionally, strict smoking cessation and weight control are recommended to reduce disability.

Cognitive behavioral therapy for complex regional pain syndrome

Complex regional pain syndrome (CRPS) is often associated with severe mental impairments. Initial pain-related fears in particular appear to be negative predictors for long-term therapy results. Procedures for cognitive behavioral therapy are an important component of treatment. The psychotherapy of CRPS consists of various elements that are implemented in the different phases of treatment. In the beginning the focus is on targeted psychoeducation. In the following activation phase body awareness exercises are accompanied by occupational and physiotherapeutic treatment in order to improve the perception of individual maximum loads. Behavioral analyses are used to uncover dysfunctional coping patterns, such as afear avoidance coping strategy. In this case the use of graded activity treatment approach is indicated, in which the activity level is gradually increased. In the transfer phase psychotherapy supports affected patients in (re)designing their professional and private environments.

Clinical Trial: Study to Investigate the Efficacy and Safety of the Alpha-2-Delta Ligand PD-217,014 in Patients With Irritable Bowel Syndrome.

Despite the emergence of drugs to treat irritable bowel syndrome (IBS), improving abdominal pain can still be challenging. α2δ ligands, such as gabapentin and pregabalin, are sometimes used off-label to tackle this problem. However, evidence for efficacy is limited, and no large-scale studies have been published. To study the efficacy of the α2δ ligand PD-217,014 in IBS. This multi-centre, double-blind, randomised, placebo-controlled, parallel group study randomised participants with Rome II-defined IBS to 150 or 300 mg b.d. of PD-217,014 or placebo b.d. for 4 weeks. The primary efficacy endpoint was responder, defined as having adequate relief of abdominal pain/discomfort for ≥ 50% of the active treatment period. Key secondary endpoints were change from baseline in abdominal pain, bloating, stool frequency/consistency, and global assessment of IBS symptoms. We randomised 330 participants [aged 19-73 years; 209 (65%) female] satisfying Rome II criteria, 322 (98%) were treated, and of whom 271 (84%) completed the study. In this study, 321 satisfied Rome IV criteria. Neither dose of PD-217,014 improved the percentage of participants reporting adequate relief of abdominal pain/discomfort compared with placebo, either using the Rome II-defined total cohort or Rome II and IV IBS bowel habit sub-types. There were similar observations for secondary endpoints, and no association between abdominal pain or anxiety levels at baseline with participant improvement. PD-217,014 was generally well tolerated. This first large, dose-ranging trial examining the efficacy of PD-217,014 showed no significant efficacy in participants with IBS or bowel habit sub-types, irrespective of their pain and anxiety levels.

Feasibility and preliminary efficacy of a physical activity intervention in adults with lymphoma undergoing treatment

BackgroundTo determine the feasibility, acceptability, and preliminary efficacy of a 6-month tailored non-linear progressive physical activity intervention (PAI) for lymphoma patients undergoing chemotherapy.MethodsPatients newly diagnosed with lymphoma (non-Hodgkin (NHL) or Hodgkin (HL)) were randomized into the PAI or healthy living intervention (HLI) control (2:1). Feasibility was assessed by examining accrual, adherence, and retention rates. Participants completed assessments of exercise capacity (VO2 peak and 6-min walk distance (6MWD)), objective and self-reported levels of physical activity, MRI-derived cardiovascular functioning (Left Ventricular Ejection Fraction [LVEF], stroke volume, and cardiac output), and self-reported health-related and disease-specific quality of life and self-efficacy for exercise at baseline, 3, and 6 months.ResultsOne hundred and forty-five individuals were screened with 23 of 84 eligible patients agreeing to participate (27%). Three participants withdrew before baseline testing. Out of the 20 participants randomized to the PAI (n = 13) and HLI groups (n = 7), 18 completed the intervention resulting in an overall retention rate of 78%. The adherence rates to the PAI and HLI were 85% and 87%, respectively. One non-serious adverse event was registered. VO2 peak ranged from 15.5–28.0 ml/kg/min at baseline and participants in both groups improved by 6 months. Physical activity levels and cardiovascular function were reduced prior to treatment but did not deteriorate further.ConclusionsImplementing a tailored PAI in adults with lymphoma during active treatment is feasible, was well received by participants and shows preliminary efficacy for limiting a decline in function during treatment. Potential Implications for Cancer Survivors: Physical activity may be beneficial for improving exercise capacity and health-related quality of life in patients undergoing chemotherapy.Trial registration#NCT01719562 ClinicalTrials.gov. Registered July 2, 2019—retrospectively registered.

Use of Modified Activated Carbon in Groundwater Remediation for Human Consumption

This study aimed to produce activated carbon from desilicated rice husks using various carbonization and activation methods, including a tube furnace, muffle furnace, and artisanal pyrolysis. The resulting activated carbons were characterized for their adsorptive capacity through the determination of iodine number and methylene blue adsorption; these are key indicators of specific surface area and adsorbent quality. Advanced characterization techniques were employed, such as scanning electron microscopy (SEM), which revealed a highly porous and irregular surface structure, and energy dispersive X-ray spectroscopy (EDS), confirming the effective removal of impurities and optimization of the elemental composition. Atomic force microscopy (AFM) demonstrated favorable surface roughness for adsorption processes. Among the samples, CaDH162-CADH53 exhibited the highest performance, with an iodine number of 1094.8 mg/g and a yield of 93.5%, signifying a high adsorption capacity. The activation treatments with phosphoric acid and calcium carbonate significantly improved the porous structure, further enhancing the material’s adsorptive properties. In conclusion, the activated carbons produced in this study demonstrated optimal physicochemical properties for water purification and contaminant treatment applications. These findings highlight the potential of using agricultural waste, such as rice husk, as a sustainable and scalable alternative for industrial-scale activated carbon production.

Randomized clinical trial of a digital integrative medicine intervention among patients undergoing active cancer treatment

Exercise and mindfulness-based interventions have growing evidence for managing fatigue and comorbid symptoms; however, packaging them in a cohesive digital way for patients undergoing cancer treatment has not been evaluated. We conducted a randomized controlled trial to assess the impact of a 12 week digital integrative medicine program, Integrative Medicine at Home (IM@Home), versus enhanced usual care on fatigue severity (primary outcome), comorbid symptoms and acute healthcare utilization (secondary outcomes), in 200 patients with solid tumors experiencing fatigue during treatment. Fatigue severity decreased more in IM@Home than in the control (1.99 vs. 1.51 points; p = 0.04). IM@Home participants also had reduced symptom distress (p = 0.003), anxiety (p = 0.03), and depression (p = 0.02). Acute healthcare utilization was lower with IM@Home, with fewer emergency department visits (rate ratio 0.49; p = 0.04), hospitalizations (4% vs. 12.9%; p = 0.03), and shorter hospital stays (4.25 vs. 10 days; p < 0.001). These promising findings should be confirmed in phase III clinical trials. “Study registered at clinicaltrials.gov (NCT05053230) on 09-20-2021”.

For adults undergoing active cancer treatment, how does cardiovascular training compare with resistance training for reducing fatigue and improving quality of life?

For adults undergoing active cancer treatment, how does cardiovascular training compare with resistance training for reducing fatigue and improving quality of life?

Placebo nonresponders: An experimental investigation on their unreliability over time.

In order to disentangle the effects of drugs from placebo responses, several approaches have been used, such as a placebo run-in phase in which only placebo nonresponders, or poor responders, are considered for further randomization to either placebo or active treatment. This study is aimed at investigating the variability of placebo nonresponders obtained through the classical placebo run-in paradigm (group RUN) and through mismatch conditioning (group MIS), as done in our previous study. To do this, we simulated a real clinical trial in the laboratory, in which the placebo responders of both groups were discarded and the remaining nonresponders of both groups RUN and MIS were randomized to either continuing on placebo (groups RUN-P and MIS-P, respectively) or receiving topical 0.5% lidocaine (groups RUN-L and MIS-L, respectively) applied to the skin. By measuring pain thresholds, we found that the placebo nonresponders selected on the first day of the experiment showed different responses on the following day in both group RUN and MIS. This led to no significant differences between placebo and lidocaine in both groups. Although this is an experimental laboratory situation far from the clinical trial setting, these findings show that placebo nonresponders are not necessarily constant over time, both when a placebo run-in protocol is used and when nonresponders are created in the laboratory. This questions the reliability of selecting placebo nonresponders as a methodological approach in clinical research. Therefore, we suggest reconsidering the validity and usefulness of placebo run-in protocols. PERSPECTIVE: Placebo nonresponders are sometime selected for further randomization to either placebo or active treatment. In this experimental study, which is a laboratory simulation of a clinical trial, we found that placebo nonresponders vary from day to day, thus questioning their validity as a methodological approach in clinical research.

Patient Acceptability of the First Integrative Pediatric Oncology Unit in Spain—The Pediatric Cancer Center Barcelona Experience: A Retrospective Study

Background/Objectives: Pediatric cancer patients and their families are increasingly combining conventional treatment with complementary therapies. These therapies are not covered by most public healthcare systems, and Spain is not an exception. To address this need, the Pediatric Cancer Center Barcelona, at the Hospital Sant Joan de Déu (Spain), established the first integrative pediatric oncology unit in 2019. The objective of this study is to describe the feasibility of implementing a pediatric integrative oncology unit, in terms of the acceptance of the interventions, as well as to present initial data on the care activities; Methods: This is a retrospective single-center study, conducted in the Pediatric Cancer Center Barcelona, at the Hospital Sant Joan de Déu. Data from patients during a two-year period were collected by reviewing medical records in a pseudonymous manner; Results: From 1 September 2019 to 30 September 2021, the unit was visited by 433 patients. The median age of patients was 9 years [range 0–34 years], with 266 boys (61.4%) and 167 girls (38.6%). Of these patients, 90.1% were in active treatment, 7.6% were survivors, and 2.3% were at the end of life. Acupuncture was recommended to 227 patients, with a 94.7% acceptance rate. Aromatherapy was recommended to 114 patients, with a 100% acceptance. The reflexology team visited 129 patients, delivering a total of 414 sessions, with a 96.1% acceptance.; Conclusions: The findings of our study support the feasibility of implementing an Integrative Pediatric Oncology Unit within a patient-centered care model in a comprehensive pediatric cancer center. The high acceptance rates of various complementary therapies highlight their potential role in enhancing supportive care for pediatric oncology patients.

Effects of continuous positive airway pressure treatment on arterial stiffness and inflammatory factors in patients with coronary heart disease complicated with obstructive sleep apnea

BackgroundContinuous Positive Airway Pressure (CPAP) treatment brings more benefits than risks to most coronary heart disease (CHD) patients with obstructive sleep apnea (OSA). However, the pathophysiological mechanism by which CPAP treatment improves the prognosis of patients with CHD and OSA remains unclear. The purpose of this study was to clarify whether CPAP can improve arterial stiffness and inflammatory factor levels in CHD patients with OSA, and to further improve prognosis.Method59 patients with coronary heart disease complicated by moderate to severe sleep apnea were divided into a CPAP treatment group (CPAP + coronary heart disease standard treatment) and a control group (only coronary heart disease standard treatment). Peripheral blood test reports were collected and pulse wave velocity (PWV) measurements were performed for each patient at the beginning, 3 months, and 6 months of treatment.ResultsAfter 6 months of treatment, the CPAP group showed more significant improvement in the levels of inflammatory factors such as white blood cell (WBC), neutrophil (N), C-reactive protein (CRP), interleukin-6 (IL-6), procalcitonin (PCT), and PWV than the control group.ConclusionAfter active treatment with CPAP, arterial stiffness and inflammatory cytokine levels in patients with coronary heart disease and OSA improved. This association should be given more attention in clinical practice, and sleep apnea should be actively treated.

Complement proteins in axial spondyloarthritis: associations with disease activity and TNFi treatment response in a multicenter randomised controlled trial

Complement proteins in axial spondyloarthritis: associations with disease activity and TNFi treatment response in a multicenter randomised controlled trial

Knowing is Half the Battle: The Factors Leading to Efficient Recruitment of Representative Samples in Schizophrenia Research.

Drug development in schizophrenia is limited by thedifferential scaling of the active treatment and placebo arms of a study, such that, as the number of sites increases, the magnitude of placebo response disproportionately increases. The objective of this article was to identify factors conducive to efficient recruitment as a step towards trial designs allowing recruitment of more participants per site, leading to reduced variability, and potentially a smaller placebo effect. Using the information of 554 individuals, we calculated the percentage of individuals who were screened, consented, and retained in our research, along with rationale for nonconsent. Independent t tests and Chi-squared tests were performed to compare participant characteristics. Out of the 273 individuals who were fully screened, 84 did not progress to the consented stage owing to various reasons, leading to a total of 189 individuals who were screened and consented and a total of 365 individuals who were either incompletely screened or not consented into a study. Individuals with an externally validated medical history showed the highest yield in being consented and retained in research as new participants. In particular, chart reviews from clinics were highly efficient (25.8%) in facilitating new participants' enrollment, even when theseindividuals were not actively/prospectively seeking research. The most common reason for nonconsent was difficulty in telephone or email contact. Consenting and nonconsenting participants were similar in demographics, and recruitment sources only differed in their reported substance use. Referrals and chart reviews from known clinics were the most efficient method in retaining new participants, highlighting the importance of external validation and communication between research and clinical staff within a system. Consenting participants showed no significant differences from the database as a whole, demonstrating that the study samples were representative. Future studies should aim to confirm the present findings at other academic and commercial research centers.

Secondary prevention of dental hyperesthesia in young individuals undergoing active orthodontic treatment

Secondary prevention of dental hyperesthesia in young individuals undergoing active orthodontic treatment

Monotropein attenuates renal cell carcinoma cell progression and M2 macrophage polarization by weakening NF-κB.

The study aimed to investigate the effect and mechanism of monotropein on renal cell carcinoma (RCC). After monotropein and NF-κB receptor activator (RANKL) treatment, cell proliferation, invasion, and apoptosis were evaluated using CCK-8, Transwell, and flow cytometry. Primary macrophages co-cultured with monotropein-treated RCC cells were analyzed to evaluate macrophage polarization using qRT-PCR, western blot, and ELISA assays by detecting the expression of M2 markers (CD206, CD168) and cytokines (IL-10, TGF-β). Additionally, the therapeutic efficacy of monotropein was examined using an RCC mouse xenograft model. Monotropein could inhibit the proliferation, invasion, and M2 macrophage polarization and accelerate the apoptosis of RCC cells. Mechanistically, monotropein suppressed NF-κB pathway activation in RCC cells and reduced the expression of NF-κB downstream targets, including Bcl-2, c-Myc, and MMP9. RANKL could eliminate the effect of monotropein on RCC progression. In primary macrophages co-cultured with monotropein-treated RCC cells, monotropein downregulated M2 polarization markers and cytokines, further supporting its role in modulating the tumor microenvironment. In mouse models, monotropein reduced RCC tumor growth, induced apoptosis, and blocked NF-κB pathway. Monotropein prevents RCC malignant progression and reduces M2 macrophage polarization by suppressing the NF-κB pathway, suggesting that monotropein may serve as a potential therapeutic agent for RCC by targeting both tumor cells and the tumor microenvironment.

Comparison of the effectiveness of 2 shockwave therapy protocols for the treatment of vascular erectile dysfunction: a randomized, multicenter, open-label, noninferiority, phase 4 clinical trial.

Shockwave therapy is an optional adjuvant treatment for vascular erectile dysfunction (ED). There is variability in treatment protocols and challenges with patients adherence to the weekly protocol, which is the most commonly used. This study aimed to evaluate the noninferiority of a monthly shockwave therapy protocol compared to the weekly protocol for treating vascular ED. A randomized, open-label, control active, multicenter clinical trial was conducted. A total of 184 men diagnosed with vascular ED, without comorbid conditions associated with secondary dysfunction or active treatment for ED, were included across 5 clinics in Mexico and Colombia. Patients were randomized to receive either 6 sessions of weekly or monthly shockwave therapy, applying the same parameters for both groups. The primary outcome was the change in the International Index of Erectile Function-Erectile Function Domain (IIEF-EF) Questionnaire score at 24weeks after treatment, assessed using a noninferiority approach. Secondary outcomes included clinical improvement, erection hardness, and self-esteem (SEAR Questionnaire) at posttreatment, 12weeks, and 24weeks of follow-up. At 24-week posttreatment, the average change in IIEF-EF was 1.93 (± 6.55; 95% CI 0.49-3.38) in the weekly group and 4.30 (± 6.78; 95% CI 2.69-5.9) in the monthly group, demonstrating noninferiority of the monthly protocol (difference -2.36; 95% CI -4.4 to -0.2; noninferiority P< .0001). At the end of treatment, clinical improvement was achieved by 55.2% of participants in the monthly protocol and 30.9% in the weekly (P= .042). No significant differences were found in other outcomes. A 6-session monthly shockwave therapy regimen could improve erectile function in men with ED. This is the largest clinical trial to date evaluating shockwave therapy regimens for ED. The principal limitations were the absence of objective vascular assessment of the changes produced by shockwaves, and the absence of a placebo control group. A monthly protocol of 6 shockwave therapy sessions is noninferior to a weekly protocol up to 6 months after therapy, in men with vascular ED.

Structure-Stability Relationships in Pt-Alloy Nanoparticles Using Identical-Location Four-Dimensional Scanning Transmission Electron Microscopy and Unsupervised Machine Learning.

Nanoparticulate electrocatalysts for the oxygen reduction reaction are structurally diverse materials. Scanning transmission electron microscopy (STEM) has long been the go-to tool to obtain high-quality information about their nanoscale structure. More recently, its four-dimensional modality has emerged as a tool for a comprehensive crystal structure analysis using large data sets of diffraction patterns. In this study, we track the alternations of the crystal structure of individual carbon-supported PtCu3 nanoparticles before and after fuel cell-relevant activation treatment, consisting of a mild acid-washing protocol and potential cycling, essential for forming an active catalyst. To take full advantage of the rich, identical location 4D-STEM capabilities, unsupervised algorithms were used for the complex data analysis, starting with k-means clustering followed by non-negative matrix factorization, to find commonly occurring signals within specific nanoparticle data. The study revealed domains with (partially) ordered alloy structures, twin boundaries, and local amorphization. After activation, specific nanoparticle surface sites exhibited a loss of crystallinity which can be correlated to the simultaneous local scarcity of the ordered alloy phase, confirming the enhanced stability of the ordered alloy during potential cycling activation conditions. With the capabilities of our in-house developed identical-location 4D-STEM approach to track changes in individual nanoparticles, combined with advanced data analysis, we determine how activation treatment affects the electrocatalysts' local crystal structure. Such an approach provides considerably richer insights and is much more sensitive to minor changes than traditional STEM imaging. This workflow requires little manual input, has a reasonable computational complexity, and is transferrable to other functional nanomaterials.

A mobile intervention to reduce anxiety among university students, faculty, and staff: Mixed methods study on users' experiences.

Anxiety is highly prevalent among college communities, with significant numbers of students, faculty, and staff experiencing severe anxiety symptoms. Digital mental health interventions (DMHIs), including Cognitive Bias Modification for Interpretation (CBM-I), offer promising solutions to enhance access to mental health care, yet there is a critical need to evaluate user experience and acceptability of DMHIs. CBM-I training targets cognitive biases in threat perception, aiming to increase cognitive flexibility by reducing rigid negative thought patterns and encouraging more benign interpretations of ambiguous situations. This study used questionnaire and interview data to gather feedback from users of a mobile application called "Hoos Think Calmly" (HTC), which offers brief CBM-I training doses in response to stressors commonly experienced by students, faculty, and staff at a large public university. Mixed methods were used for triangulation to enhance the validity of the findings. Qualitative data was collected through semi-structured interviews from a subset of participants (n = 22) and analyzed thematically using an inductive framework, revealing five main themes: Effectiveness of the Training Program; Feedback on Training Sessions; Barriers to Using the App; Use Patterns; and Suggestions for Improvement. Additionally, biweekly user experience questionnaires sent to all participants in the active treatment condition (n = 134) during the parent trial showed the most commonly endorsed response (by 43.30% of participants) was that the program was somewhat helpful in reducing or managing their anxiety or stress. There was overall agreement between the quantitative and qualitative findings, indicating that graduate students found it the most effective and relatable, with results being moderately positive but somewhat more mixed for undergraduate students and staff, and least positive for faculty. Findings point to clear avenues to enhance the relatability and acceptability of DMHIs across diverse demographics through increased customization and personalization, which may help guide development of future DMHIs.

Redosing with Intralymphatic GAD-Alum in the Treatment of Type 1 Diabetes: The DIAGNODE-B Pilot Trial.

Immunotherapies aimed at preserving residual beta cell function in type 1 diabetes have been successful, although the effect has been limited, or raised safety concerns. Transient effects often observed may necessitate redosing to prolong the effect, although this is not always feasible or safe. Treatment with intralymphatic GAD-alum has been shown to be tolerable and safe in persons with type 1 diabetes and has shown significant efficacy to preserve C-peptide with associated clinical benefit in individuals with the human leukocyte antigen DR3DQ2 haplotype. To further explore the feasibility and advantages of redosing with intralymphatic GAD-alum, six participants who had previously received active treatment with intralymphatic GAD-alum and carried HLA DR3-DQ2 received one additional intralymphatic dose of 4 μg GAD-alum in the pilot trial DIAGNODE-B. The participants also received 2000 U/day vitamin D (Calciferol) supplementation for two months, starting one month prior to the GAD-alum injection. During the 12-month follow-up, residual beta cell function was estimated with Mixed-Meal Tolerance Tests, and clinical and immune responses were observed. C-peptide decreased minimally, and most patients showed stable HbA1c and IDAA1c. The mean % TIR increased while the mean daily insulin dose decreased at month 12 compared to the baseline. Redosing with GAD-alum seems to be safe and tolerable, and may prolong the disease modification elicited by the original GAD-alum treatment.

How Do Maternal Gestational Diabetes and Other Concomitant Maternal Factors Determine the Perinatal Outcomes of Pregnancy?-A Retrospective Analysis.

Gestational diabetes mellitus (GDM) is associated with an increased risk of both neonatal and maternal morbidity. The aim of this retrospective study was to evaluate the frequency of perinatal complications due to GDM in the Department of Neonatology at the Medical University of Wroclaw, Poland, considering the treatment of GDM-diet and physical activity versus insulin therapy. The influence of maternal comorbidities and the COVID-19 pandemic on pregnancy outcomes was assessed. A retrospective analysis of medical records was conducted. Statistics were calculated using a range of methods, with p < 0.05 considered significant. A sample of n = 625 mothers with n = 646 newborns were included in this study. The newborns of insulin-treated mothers had cardiovascular defects more often (p < 0.05). A higher prevalence of vaginal infections was found in the diet-treated mothers (p < 0.05), while insulin-treated mothers had a higher prevalence of pregnancy-induced hypertension, pregnancy-induced hypothyroidism and obesity (p < 0.05). The mode of delivery, maternal age and maternal pregnancy-induced hypertension, obesity and cholestasis were found to influence neonatal outcomes (p < 0.05). The maternal management of GDM is not the main determinant of pregnancy outcomes, which might be affected by other maternal comorbidities. Effective initiatives are needed to control GDM, support breastfeeding and prevent adverse pregnancy outcomes.