Standard Clinical Protocol Research Articles

Treatment of equine osteoarthritis by association between a homeopathic complex and local phytotherapy – a ten-case series

Osteoarthritis is a degenerative inflammatory process and a common clinical condition in the equines, being the leading cause of performance loss and early retirement. This study proposes an innovative treatment for this affection when in a light or moderate degree, using the association between a commercial homeopathic complex Drenareuma WPTM (Curitiba, Brazil) composed of Bryonia alba 4cH, Mezereum 6cH, Ranunculus bulbosus 5cH, Rhus Toxicodendron 5cH, Ruta graveolens 5cH and excipients, administered in pills (one pill each day for 90 days) and a daily topic treatment of an ointment made from Cordia verbenacea extract and excipients - CuradermyTM (São Paulo, Brazil). Ten horses were selected, in sequence, from the UNIP veterinary polyclinics, São José dos Campos, Brazil, according to the inclusion and exclusion criteria, and the tutor expressed writing agreement. On days zero and 90, the animals were carefully examined following a standard clinical protocol and submitted to image diagnosis techniques of the affected carpus-phalanges articulation at orthogonal X-ray projections and ultrasound images of dorsal-palmar/latero-medial faces at longitudinal/transversal sections. The final observation was scored according to the Naranjo modified criteria. On day zero, there was an apparent volume increase of soft tissues with reduced articular space, bone lysis, subchondral bone sclerosis, and periarticular osteophytes. On day 90, all animals presented some clinical improvement, with no claudication, decreased subchondral bone sclerosis, bone lysis, periosteal reaction, and osteophytes, showing an apparent articular regeneration. There were no observable side effects. The Naranjo scores varied from 10 to 11, with a maximum of 13 points. The results indicate the effectiveness of the proposed protocol, which justifies a further randomized clinical trial to establish its putative efficacy. This study was approved by the UNIP ethics committee (CEUA nº 1847210823).

Impact of adalimumab on erectile dysfunction, sperm parameters and hormonal profile in male psoriasis patients: a six-month observational study.

Psoriasis, a chronic inflammatory skin disease, is associated with systemic complications that extend beyond cutaneous lesions, including cardiovascular risks and sexual dysfunction. Erectile dysfunction (ED) is notably more prevalent in male psoriasis patients, likely driven by both systemic inflammation and psychological stress. Adalimumab (ADA), a tumor necrosis factor-alpha (TNF-α) inhibitor, has been shown to effectively reduce psoriasis severity, but its effects on sexual and reproductive health remain underexplored. This study investigates the impact of ADA on erectile function, sperm parameters, and hormonal profiles in male psoriasis patients. This six-month prospective observational study included 33 biologic-naïve male patients aged 18-50 years with moderate-to-severe plaque psoriasis (Psoriasis Area and Severity Index [PASI] > 10). Patients received ADA according to standard clinical protocols. Erectile function was assessed using the International Index of Erectile Function (IIEF-5). Sperm parameters, including ejaculate volume, sperm concentration, total sperm count, motility, vitality, and morphology, were analyzed following World Health Organization (WHO) 2010 criteria. Hormonal profiles (testosterone, luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol, and prolactin) were measured via standardized assays. Statistical analyses were performed using paired t-tests or Wilcoxon signed-rank tests, with p-values < 0.05 considered significant. ADA significantly improved erectile function, as the mean IIEF-5 score increased from 21.3 ± 2.2 to 22.2 ± 1.9 (p = 0.03). The percentage of patients with ED decreased from 51.5% at baseline to 36.4% post-treatment (p < 0.001). Progressive sperm motility and vitality showed statistically significant improvement post-treatment (p = 0.02 and p = 0.04, respectively), while other sperm parameters remained unchanged. Total testosterone levels significantly increased from 3.4 ± 0.4 ng/ml to 3.5 ± 0.4 ng/ml (p = 0.02), while LH, FSH, estradiol, and prolactin levels showed no significant changes. The anti-inflammatory properties of adalimumab, through the inhibition of TNF-α, not only reduce psoriasis severity but also appear to exert positive effects on male sexual and reproductive health. Our study demonstrated significant improvements in erectile function, sperm motility, vitality, and testosterone levels in male psoriasis patients after adalimumab therapy. These findings suggest that beyond its role in controlling psoriatic skin lesions, adalimumab may help mitigate the systemic inflammatory burden that contributes to sexual dysfunction and impaired spermatogenesis. Future long-term studies are essential to further explore the sustained impact of TNF-α inhibition on male fertility and reproductive outcomes.

Transdiagnostic Attentional Deficits Are Associated with Depressive and Externalizing Symptoms in Children and Adolescents with Neuropsychiatric Disorders.

Although inattention, impulsivity, and impairments to vigilance are most associated with attention-deficit/hyperactivity disorder (ADHD), transdiagnostic attentional deficits are prevalent across all psychiatric disorders. To further elucidate this relationship, the present study investigated parent-reported neuropsychiatric symptom correlates of attention deficits using the factor structure of the Conners' Continuous Performance Test (CPT-II), a neuropsychological test of attention. Two-hundred and eighteen children and adolescents (7-21years old) completed the CPT-II as part of standard clinical protocol during outpatient pediatric neuropsychology visits. The factor structure of the CPT-II was determined with a principal component analysis (PCA) using Promax rotation. Pearson correlation analyses and regression models examined the relationship between the generated factor structure, parent-reported clinical symptoms, and pre-determined clinical diagnoses. Results from the PCA suggested a three-factor model best supported the structure of the CPT-II, and were subsequently defined as inattention, impulsivity, and vigilance. Performance-based inattention was significantly correlated with parent-reported hyperactivity, aggression, conduct problems, and depression. Parent-reported depressive symptoms and conduct problems were the strongest correlates of performance-based inattention, not hyperactivity or aggression. Performance-based inattention was significantly associated with an ADHD diagnosis but not a depression or anxiety diagnosis. Findings suggest attentional deficits are not specific to any one disorder. To enhance the identification, classification, and treatment of neuropsychiatric disorders, both researchers and clinicians alike must diminish the importance of categorical approaches to child/adolescent psychopathology and continue to consider the dimensionality of transdiagnostic characteristics such as inattention.

Three-dimensional finite element analysis of occlusal stress on maxillary first molars with different marginal morphologies restored with occlusal veneers

BackgroundThere are differences in the research results regarding which edge design of occlusal veneers can achieve the best long-term success rate as a relatively new fixed prosthesis restoration method. Further research is needed. The three-dimensional finite element method was used to conduct stress analysis on occlusal veneers of maxillary first permanent molars with different thicknesses and margin preparation designs. The aim of this study was to provide mechanical research evidence and a reference for exploring standardized clinical protocols for the design of occlusal veneer restorations of maxillary first molars.MethodA 3Shape (Intraoral Scanner) was used to scan the maxillary first molar teeth in vitro, after which 3D printing was carried out. Three different edge designs were applied to identical teeth: straight-beveled finishing line(SFL), chamfer finishing line(CFL), and standard cuspal inclination(SCI). Preparation was carried out with a thickness of 0.5 mm. Using the surface deformation feature, the occlusal veneer was thickened to 0.5 mm and 1.0 mm, and periodontal ligaments were added. They were then placed into the upper and lower jaws and dental arches. Finite element analysis was performed after applying bite force dispersion to the loading area on the mandible following dynamic contact.Results(1) As the thickness increased, the maximum Von Mises stress in the occlusal veneers SFL and CFL also increased, while the SCI exhibited the opposite trend. (2). The trend of the maximum Von Mises stress in the adhesive layer decrease gradually with increasing thickness of the occlusal veneer. The stresses of the SFL and CFL is concentrated primarily at the edge position below the functional cusp, resulting in relatively low adhesive stress. However, in the SCI group, the maximum stress at the edge of the adhesive layer exceeds the maximum shear strength of commonly used adhesives.ConclusionsUnder the experimental conditions, the mechanical properties of the maximum Von Mises stress in the SFL, CFL, and SCI occlusal veneers meet clinical needs. Incorporating the minimally invasive concept of tooth preservation, a thickness of 1.0 mm are optimal for glass ceramic occlusal veneers on maxillary first molars.

Things seen and unseen: 2. Anaemia affects urban rich Nigerian adolescents more than other socio‑economic status groups.

Background: Anaemia is very prevalent globally and is thought to be linearly associated with wealth and to affect females and rural residents more than males and urban residents. Objectives: This study was designed to investigate this thought in a population of adolescents in Ebonyi State, Nigeria. Methods: Standard clinical protocols were used. A total of 362 adolescents (63.5% females) were studied. Anaemia was diagnosed on the basis of the World Health Organization (WHO) criteria. Results: Aggregate anaemia was found in 50.0% of the general population (43.9% males, 53.5% females) and was most prevalent in the urban upper socio‑economic status (SES) group (62.3%; 70.0% females, 52.2% males). Severe anaemia was present in 7.2% of the general population (9.1% males, 6.1% females). It was most prevalent amongst the 10-11 years age bracket (15.6%). Moderate and mild anaemia were found in 22.4% and 20.4% of the general population and in 13.0%, 11.4%, 8.3% and 6.0% of the urban upper, rural, urban low and middle SES groups, respectively. But in the rural area group, severe anaemia existed without wide sex variations. Moderate anaemia was most prevalent in the urban middle and upper SES groups (29.0% and 26.4%, respectively) with a clear female preponderance. Mild anaemia was the least prevalent (15.3%) in the urban middle SES group. Conclusions: The higher prevalence of severe anaemia in boys and the higher burden in the urban higher SES group warrant a rethink of the public health interventions used in Nigeria. Adolescent boys and urban upper SES groups should be targeted in nutrition interventions related to anaemia.

Intrasubject variability in potential early markers of sensorineural hearing damage.

The quest for noninvasive early markers for sensorineural hearing loss (SNHL) has yielded diverse measures of interest. However, comprehensive studies evaluating the test-retest reliability of multiple measures and stimuli within a single study are scarce, and a standardized clinical protocol for robust early markers of SNHL remains elusive. To address these gaps, this study explores the intra-subject variability of various potential electroencephalogram- (EEG-) biomarkers for cochlear synaptopathy (CS) and other SNHL-markers in the same individuals. Fifteen normal-hearing young adults underwent repeated measures of (extended high-frequency) pure-tone audiometry, speech-in-noise intelligibility, distortion-product otoacoustic emissions (DPOAEs), and auditory evoked potentials; comprising envelope following responses (EFR) and auditory brainstem responses (ABR). Results confirm high reliability in pure-tone audiometry, whereas the matrix sentence-test exhibited a significant learning effect. The reliability of DPOAEs varied across three evaluation methods, each employing distinct SNR-based criteria for DPOAE-datapoints. EFRs exhibited superior test-retest reliability compared to ABR-amplitudes. Our findings emphasize the need for careful interpretation of presumed noninvasive SNHL measures. While tonal-audiometry's robustness was corroborated, we observed a confounding learning effect in longitudinal speech audiometry. The variability in DPOAEs highlights the importance of consistent ear probe replacement and meticulous measurement techniques, indicating that DPOAE test-retest reliability is significantly compromised under less-than-ideal conditions. As potential EEG-biomarkers of CS, EFRs are preferred over ABR-amplitudes based on the current study results.

Spinal Cord Blood Perfusion Deficit is Associated with Clinical Impairment after Spinal Cord Injury.

Spinal cord injury (SCI) results in intramedullary microvasculature disruption and blood perfusion deficit at and remote from the injury site. However, the relationship between remote vascular impairment and functional recovery remains understudied. We characterized perfusion impairment invivo, rostral to the injury, using magnetic resonance imaging (MRI), and investigated its association with lesion extent and impairment following SCI. Twenty-one patients with chronic cervical SCI and 39 healthy controls (HC) underwent a high-resolution MRI protocol, including intravoxel incoherent motion (IVIM) and T2*-weighted MRI covering C1-C3 cervical levels, as well as T2-weighted MRI to determine lesion volumes. IVIM matrices (i.e., blood volume fraction, velocity, flow indices, and diffusion) and cord structural characteristics were calculated to assess perfusion changes and cervical cord atrophy, respectively. Patients with SCI additionally underwent a standard clinical examination protocol to assess functional impairment. Correlation analysis was used to investigate associations between IVIM parameters with lesion volume and sensorimotor dysfunction. Cervical cord white and gray matter were atrophied (27.60% and 21.10%, p < 0.0001, respectively) above the cervical cord injury, accompanied by a lower blood volume fraction (-22.05%, p < 0.001) and a higher blood velocity-related index (+38.72%, p < 0.0001) in patients with SCI compared with HC. Crucially, gray matter remote perfusion deficit correlated with larger lesion volumes and clinical impairment. This study shows clinically eloquent perfusion deficit rostral to a SCI, its magnitude driven by injury severity. These findings indicate trauma-induced widespread microvascular alterations beyond the injury site. Perfusion MRI matrices in the spinal cord hold promise as biomarkers for monitoring treatment effects and dynamic changes in microvasculature integrity following SCI.

Intravitreal indocyanine green is toxic to the retinal cells

BackgroundIndocyanine green (ICG) is widely used to stain the epiretinal membranes and internal limiting membranes during the pars plana vitrectomy (PPV). This study aims to evaluate the effect of ICG on rat retinas and various retinal cell lines, including ARPE-19 cells, rMC-1 cells, BV2 cells, HRMECs and R28 cells. MethodsICG solutions were prepared and diluted with glucose solution (GS) according to the standard clinical protocols. The retinal cell lines, including ARPE-19 cells, rMC-1 cells, BV2 cells, HRMECs and R28 cells, were treated with the following solutions: normal glucose (NG, 5 mM), GS-1 (92.5 mM glucose), GS-2 (185.02 mM glucose), ICG-1 (92.5 mM glucose + 0.43 mM ICG), or ICG-2 (185.02 mM glucose + 0.86 mM ICG) for durations of 15 or 30 min. In vivo, the right eyes of the rats were intravitreally injected with ICG-1 or ICG-2 (2 μL), while the left eyes were intravitreally injected with GS-1 or GS-2, served as the osmotic controls, for 30 min or 60 min. The rats intravitreally injected with an equivalent volume of NG or 1x phosphate-buffered saline (1x PBS) were served as the normal control or vehicle control. The cell viability was measured with the Cell Counting Kit-8 (CCK-8), while the cell death in retinal cryosections was detected with the TUNEL assay. ResultsThe viabilities of the different retinal cell lines involved in this study were significantly reduced by both ICG-1 and ICG-2 treatments at both time points, with ICG-2 resulting in lower cell viability compared to the NG group and the osmotic control group. Additionally, GS-2 treatment also exhibited a decrease in retinal cell viabilities in vitro. To further confirm these results, intravitreal injection of ICG or GS induced more apoptotic cell death in rat retinas as evidenced by the TUNEL assay. ConclusionsThe exposure of ICG or its solvent leads to an augmented retinal cell death, which is directly proportional to the concentration and duration of exposure, both in vivo and in vitro. Caution should be exercised during vitrectomy procedures involving ICG administration during clinical practice. It is recommended to advocate for lower concentrations of ICG with reduced exposure time during ocular surgeries.

A Comparative Effectiveness Study of Speech and Surgical Outcomes: Study Overview.

To provide an overview of the Cleft Outcomes Research NETwork (CORNET) and the CORNET Speech and Surgery study. The study is (1) comparing speech outcomes and fistula rate between two common palate repair techniques, straight-line closure with intra-velar veloplasty (IVVP) and Furlow Double-Opposing Z-palatoplasty (Furlow Z-plasty); (2) summarizing practice variation in the utilization of early intervention speech-language (EI-SL) services; and (3) exploring the association between EI-SL services and speech outcomes. Prospective, longitudinal, observational, comparative effectiveness, multi-center. Twenty sites across the United States. One thousand two hundred forty-seven children with cleft palate with or without cleft lip (CP ± L). Children with submucous cleft palate or bilateral sensorineural severe to profound hearing loss were excluded from participation. Straight-line closure with IVVP or Furlow Z-plasty based on each surgeon's standard clinical protocol. The primary study outcome is perceptual ratings of hypernasality judged from speech samples collected at 3 years of age. Secondary outcomes are fistula rate, measures of speech production, and quality of life. The statistical analyses will include generalized estimating equations with propensity score weighting to address potential confounders. Recruitment was completed in February 2023; 80% of children have been retained to date. Five hundred sixty two children have completed their final 3-year speech assessment. Final study activities will end in early 2025. This study addresses long-standing questions related to the effectiveness of the two most common palatoplasty approaches and describes CORNET which provides an infrastructure that will streamline future studies in all areas of cleft care.

Improving outcomes for uncomplicated gastroschisis: clinical practice guidelines from the American Pediatric Surgical Association Outcomes and Evidence-based Practice Committee.

The authors sought better outcomes for uncomplicated gastroschisis through development of clinical practice guidelines. The authors and the American Pediatric Surgical Association Outcomes and Evidenced-based Practice Committee used an iterative process and chose two questions to develop clinical practice guidelines regarding (1) standardized nutrition protocols and (2) postnatal management strategies. An English language search of PubMed, MEDLINE, OVID, SCOPUS, and the Cochrane Library Database identified literature published between January 1, 1970, and December 31, 2019, with snowballing to 2022. The Appraisal of Guideline, Research and Evaluation reporting checklist was followed. Thirty-three studies were included with a Level of Evidence that ranged from 2 to 5 and recommendation Grades B-D. Nine evaluated standardized nutrition protocols and 24 examined postnatal management strategies. The adherence to gastroschisis-specific nutrition protocols promotes intestinal feeding and reduces TPN administration. The implementation of a standardized postnatal clinical management protocol is often significantly associated with shorter hospital stays, less mechanical ventilation use, and fewer infections. There is a lack of comparative studies to guide practice changes that improve uncomplicated gastroschisis outcomes. The implementation of gastroschisis-specific feeding and clinical care protocols is recommended. Feeding protocols often significantly reduce TPN administration, although the length of hospital stay may not consistently decrease.

Feasibility and safety of surfactant administration via laryngeal mask airway as first-line therapy for a select newborn population: results of a standardized clinical protocol.

(1) To demonstrate feasibility and safety of surfactant administration via laryngeal mask airway (LMA) as a first-line therapy. (2) To measure treatment success, defined as avoidance of intubation/invasive mechanical ventilation, and determine if specific clinical variables could predict success/failure. Observational cohort with eligible infants given surfactant using one type of LMA via standardized protocol. Data was captured prospectively followed by retrospective chart review. 120 infants ≥1250 g and 28.3-41.1 weeks gestation were included. First-line LMA surfactant therapy was successful in 70% of the infants and those infants weaned to room air significantly quicker than infants requiring subsequent intubation/mechanical ventilation (p = 0.002 by 72 h, p = 0.001 by 96 h). Clinical variables assessed could not predict treatment success/failure. Complications were infrequent and did not differ between groups. First-line LMA surfactant is feasible and safe for certain infants. Prediction of treatment success was not possible in our cohort.

A Clinical-Grade Partially Decellularized Matrix for Tracheal Replacement: Validation In Vitro and In Vivo in a Porcine Model.

The management of extensive tracheal resection followed by circumferential replacement remains a surgical challenge. Numerous techniques are proposed with mixed results. Partial decellularization of the trachea with the removal of the mucosal and submucosal cells is a promising method, reducing immunogenicity while preserving the biomechanical properties of the final matrix. Despite many research protocols and proofs of concept, no standardized clinical grade protocol is described. Furthermore, local and systemic biointegration mechanisms of decellularized trachea are not well known. Therefore, in a translational research perspective, this work set up a partial tracheal decellularization protocol in line with Cell and Tissue Products regulations. Extensive characterization of the final product is performed in vitro and in vivo. The results show that the Partially Decellularized Trachea (PDT) is cell-free in the mucosa and submucosa, while the cartilage structure is preserved, maintaining the biomechanical properties of the trachea. When implanted in the muscle in vivo for 28 days, no systemic inflammation is observed, and locally, the PDT shows an excellent biointegration and vascularization. No signs of graft rejection are observed. These encouraging results confirmed the efficacy of the clinical grade PDT production protocol, which is an important step for future clinical applications.

Radiological abnormalities of the cervicothoracic vertebrae in Warmblood horses with primary neck-related clinical signs versus controls.

Radiological observations at the cervicothoracic junction in horses with or without related clinical signs have not been comprehensively described. The aim was to evaluate the seventh cervical (C7) to second thoracic (T2) vertebrae in horses with neck-related clinical signs (neck pain and/or stiffness, neck-related forelimb lameness, or general proprioceptive [spinal] ataxia) and control horses. This prospective analytical cross-sectional study included 127 control horses and 96 cases, examined using standardized clinical and radiological protocols. Univariable logistic regression was used to calculate odds ratios (OR) and 95% confidence intervals (CI) to identify factors associated with radiological abnormalities. Severe modeling of the articular processes at C7-T1 was more likely in cases compared with controls, OR, 4.25; CI, 1.04-17.36; P=.04. Cases were more likely to have spondylolisthesis at C7-T1 than controls, OR, 3.61; CI, 1.75-7.44; P<.001. There was a lack of uniformity of disc space width at C6-C7, despite normal alignment of the vertebrae, in five (5.2%) cases and no control horses. Discospondylosis was seen in 9 (9.4%) horses at C7-T1 and 10 of 64 (15.6%) at T1-T2. The sagittal ratio for T1 was smaller for horses with neck-related forelimb lameness (P<.0002), neck pain/ stiffness (P=.04), or neurological cases (P<.001) than controls. The prevalence of radiological abnormalities at C7-T1 and T1-T2 highlights the importance of careful evaluation of the cervicothoracic junction in horses with neck-related signs.

A comprehensive survey of the clinical trial Landscape on digital therapeutics

BackgroundDigital therapeutics (DTx) is an emerging and groundbreaking medical intervention that utilizes health software to treat or alleviate various diseases, disorders, conditions, or injuries. Although the potential of digital therapy is enormous, it is still in its nascent stage and faces multiple challenges and obstacles. The purpose of this study is to provide an overview of all DTx-related clinical trials in ClinicalTrials.gov and to promote the advancement of DTx. MethodsTwo reviewers and one expert evaluated data from all DTx clinical trials on ClinicalTrials.gov as of August 8, 2023. Trials utilizing digital therapeutics independently or in combination with traditional approaches were included. Incomplete trials and those lacking an evidence-based foundation were excluded. Basic information about product launches and primary outcome measures was extracted and analyzed. ResultsA total of 280 eligible trials were categorized into treating a disease (141, 50.4 %), managing a disease (120, 42.9 %), and improving a health function (19, 6.8 %). The focus was primarily on mental and behavioral disorders, neurological disorders, and endocrine, nutritional, and metabolic disorders. The number of trials has been increasing annually, yet trial design and conduct remain inconsistent. Randomized controlled trials (RCTs) accounted for 67.5 % of completed trials, and 36 trials (12.9 %) involved products already approved for marketing. ConclusionsThe growth in clinical studies on DTx underscores their potential in healthcare. However, challenges persist in standardization, regulation, and clinical efficacy. There is a need for a harmonized global classification of digital therapeutics and standardized clinical trial protocols to ensure efficacy and improve healthcare services.

Brain Diffusion Changes in Perinatal Asphyxia Cases.

Prolonged perinatal asphyxia (PA) may cause hypoxic-ischemic damage to the brain. The aim of this study was to investigate the brain diffusion changes of patients with PA and examine the relationship with brain damage. This retrospective study included 55 patients diagnosed with PA, separated into mild and severe PA groups. For the evaluation of brain damage in all the study neonates, brain and diffusion MRI scans were performed using a 3T device. The scans were taken between 5 and 10 days postnatal, after completion of hypothermia treatment, in accordance with the standard clinical protocol of our institution. Apparent diffusion coefficient (ADC) values of the lentiform nucleus, thalamus, frontal white matter, and posterior limbs of the internal capsule were measured. Minitab package programs and SPSS version 20.0 software were used for statistical analysis and graphic drawing. Spearman's rank correlation analysis was used. The bilateral lentiform nucleus, thalamus, frontal white matter, and posterior limbs of the internal capsule ADC values were significantly higher in the severe PA group than in the mild PA group. In neonates with severe perinatal asphyxia, brain damage can be evaluated on diffusion-weighted imaging (DWI) of the cerebral deep white matter and basal ganglia. DWI, imaging with conventional brain MRI comes to the fore in clinical importance in PA patients.

Navigating the landscape of food allergies: Insights and perspectives from the AMCP Market Insights Program.

AMCP convened a panel of clinical and managed care experts to identify insights regarding the prevalence, clinical manifestations, and management approaches for immunoglobulin E-mediated food allergies. This article aims to summarize expert perspectives on health care system challenges and areas of agreement concerning the management of food allergies, and to advance payers' understanding of their role in supporting health care for patients with food allergies. Food allergy management requires dietary modification and is associated with significant patient and caregiver burdens. Emerging therapies provide hope for those living with food allergies but will likely lead to a rise in health plan pharmacy expenses. In considering the value of new treatments, it is important to consider the total cost of care and the value of preventing anaphylaxis and enhancing the patient's quality of life. Several challenges remain in identifying the appropriate patient population for treatment with newer agents and in optimizing treatment outcomes. Addressing health disparities will require standardized clinical protocols, better access to specialized allergy care, and management of comorbid conditions.

Tiny messengers, big results: A review of exosome-mediated treatments and considerations in dermatology

Exosomes are small extracellular vesicles that play an important role in intercellular communication by transporting proteins, lipids, and nucleic acids between cells. They have emerged as relevant research areas due to their involvement in regulating various physiological and pathological processes. This review explores the potential applications of exosome-based therapies in dermatology and examines the safety aspects of these treatments. Past research has demonstrated that exosomes may effectively treat conditions such as alopecia and accelerate wound healing by stimulating hair follicle growth and enhancing tissue regeneration. Studies have shown that exosomes can promote the proliferation of dermal papilla cells and hair follicle growth in cases of alopecia. They also accelerate wound healing by modulating processes involved in inflammation, cell migration, and tissue remodeling. However, more research is needed to fully characterize the long-term safety profile of exosomes and establish standardized clinical protocols. Both human-derived and plant-derived exosomes appear to have favorable safety profiles based on current evidence, though plant sources may offer advantages in terms of production and biocompatibility. Continued exploration of exosomes&amp;rsquo; mechanisms and potential risks will optimize these innovations and offer safe, effective exosome treatments to patients. While further research is warranted, current findings provide valuable insights into the applications of exosome therapy for dermatological conditions and its emerging role in precision medicine.

P-595 Increased clinical pregnancy rates using a clinical decision support tool - a retrospective cohort study

Abstract Study question Does using a clinical decision support tool, Opt-IVF, to guide hormone dosing during superovulation yield increased clinical pregnancy rates in routine clinical practice? Summary answer Higher clinical pregnancy rates were obtained using Opt-IVF to guide stimulatory hormone dosing during superovulation. What is known already ART success rates and cost depend heavily on the superovulation stage of the cycle. Two prospective single-center trials and one prospective multi-center trial had shown that using Opt-IVF to guide dosing resulted in increased numbers of high-quality embryos, used lower hormone doses, and required less ultrasound testing. This is a retrospective cohort study of the use of Opt-IVF in clinical practice over 12 months compared with the control cohort from the previous 12 months. Study design, size, duration Design: The study examined patients undergoing an IVF cycle using Opt-IVF in a single center for 12 months. Opt-IVF was used in all patients who presented to one of the investigators at Akanksha Hospital during the study period. As a comparison group, we examined patients from the previous 12 months when Opt-IVF was not used, and standard clinical protocols were followed to guide dosing. Duration: The study was conducted over 24 months Participants/materials, setting, methods 204 women aged 25-45 years underwent superovulation using hormone doses suggested by Opt-IVF (intervention). Of the participants, 19% were poor responders, 74% were below 35 years of age, 19% were 35-39 years of age, and 7% were above 39 years of age. The control group included 207 women, of whom 10% were poor responders. 72% were below 35 years of age, 26% were 35-39 years, and 2% were above 39 years of age. Main results and the role of chance The participants in the intervention group required significantly lower cumulative gonadotropin dosage compared to the control group during their controlled ovarian stimulation cycles (p &amp;lt; 0.0001). The average number of total embryos was 20% higher (p &amp;lt; 0.001), and the average number of good-quality embryos was 50% higher (p &amp;lt; 0.0001) in the Opt-IVF group than in the control group. Only 4.9% of cycles were canceled in the intervention group, compared to 12.9% canceled in the control group. Overall, Clinical pregnancy rates (including canceled cycles) increased from 35 % in the control group to 43% in the intervention group. The clinical pregnancy rate for poor responder patients was 39% in the Opt-IVF group but was only 16% in controls (p &amp;lt; 0.0001). Similarly, the clinical pregnancy rates were 34% in patients ages 35-39 years and 33% in patients above 39 years of age, much higher than the corresponding clinical pregnancy rates in controls (27% and 0%, respectively). Higher clinical pregnancy rates were also noted in the intervention group for normal responders and for younger patients. Limitations, reasons for caution This is a single-center retrospective cohort study. Wider implications of the findings Using Opt-IVF to guide dosing resulted in increased numbers of high-quality embryos and higher clinical pregnancy rates, particularly among older patients and poor responders. The proportions of these patients can be expected to grow in the future, so improving results in such patients is essential. Trial registration number not applicable

Enhancing the diagnostic yield of esophageal manometry using distension-contraction plots of peristalsis and artificial intelligence.

Our prior study reveals that the distension-contraction profiles using high-resolution manometry impedance recordings can distinguish patients with dysphagia symptom but normal esophageal function testing ("functional dysphagia") from control subjects. The aim of this study was to determine the diagnostic value of the recording protocol used in our prior studies (10-mL swallows with subjects in the Trendelenburg position) against the standard clinical protocol (5-mL swallows with subjects in the supine position). We used advanced machine learning techniques and robust metrics for classification purposes. Studies were performed on 30 healthy subjects and 30 patients with functional dysphagia. A custom-built software was used to extract the relevant distension-contraction features of esophageal peristalsis. Ensemble methods, i.e., gradient boost, support vector machines (SVMs), and logit boost, were used as the primary machine learning algorithms. Although the individual contraction features were marginally different between the two groups, the distension features of peristalsis were significantly different. The receiver operating characteristic (ROC) curve values for the standard recording protocol and the distension features ranged from 0.74 to 0.82; they were significantly better for the protocol used in our prior studies, ranging from 0.81 to 0.91. The ROC curve values using three machine learning algorithms were far superior for the distension than the contraction features of esophageal peristalsis, revealing a value of 0.95 for the SVM algorithm. Current patient classification for esophageal motility disorders, based on the contraction phase of peristalsis, ignores a large number of patients who have an abnormality in the distension phase of peristalsis. Distension-contraction plots should be the standard for assessing esophageal peristalsis in clinical practice.NEW & NOTEWORTHY Our findings underscore the superiority of distension features over contraction metrics in diagnosing esophageal dysfunctions. By leveraging state-of-the-art machine learning techniques, our study highlights the diagnostic potential of distension-contraction plots of peristalsis. Implementation of these plots could significantly enhance the accuracy of identifying patients with esophageal motor disorders, advocating for their adoption as the standard in clinical practice.

Interoceptive awareness in a clinical setting: the need to bring interoceptive perspectives into clinical evaluation.

Interoceptive awareness (IA) is crucial to understanding mental health. The Multidimensional Assessment of Interoceptive Awareness (MAIA) scale, available in approximately 30 languages, has gained global recognition for its research applicability. This review highlights the critical importance of integrating IA evaluation in clinical settings, advocating for the MAIA scale's potential as a screening tool. Through an examination of academic databases, including Scopus, PubMed, Google Scholar, and J-STOR, our analysis spans seven mental health domains: eating disorders (ED), depression, stress, anxiety, autism spectrum disorder (ASD), chronic pain, and suicide ideation (SI). Thirty-eight studies showed links between several dimensions of IA with different disorders. That is, ED was related to Body Trust and Self-Regulation; anxiety to Body Listening, Emotional Awareness, and Self-Regulation; depression to Noticing and Emotional Awareness; ASD to Trusting, Emotional Awareness, and Noticing; chronic pain to Not-Worrying and Self-Regulation; and SI with Trusting. These insights hold profound implications for both clinical practice and mental health research. Integrating IA assessments into standard clinical protocols has the potential to improve our understanding of pathology, enrich patient care, and enhance therapeutic strategies.