Prospective Observational Clinical Study Research Articles

Predicting deterioration in dengue using a low cost wearable for continuous clinical monitoring

Close vital signs monitoring is crucial for the clinical management of patients with dengue. We investigated performance of a non-invasive wearable utilising photoplethysmography (PPG), to provide real-time risk prediction in hospitalised individuals. We performed a prospective observational clinical study in Vietnam between January 2020 and October 2022: 153 patients were included in analyses, providing 1353 h of PPG data. Using a multi-modal transformer approach, 10-min PPG waveform segments and basic clinical data (age, sex, clinical features on admission) were used as features to continuously forecast clinical state 2 h ahead. Prediction of low-risk states (17,939/80,843; 22.1%), defined by NEWS2 and mSOFA < 6, was associated with an area under the precision-recall curve of 0.67 and an area under the receiver operator curve of 0.83. Implementation of such interventions could provide cost-effective triage and clinical care in dengue, offering opportunities for safe ambulatory patient management.

Evidence of renal tubular injury in canine patients after elective desexing.

To investigate the frequency of perioperative acute kidney injury (AKI) in American Society of Anesthesiologists (SA) Grade I canine patients undergoing elective desexing using urine microscopy techniques and assess if pre- and intraoperative factors affect risk of developing AKI. Prospective observational clinical study conducted between September 2020 and October 2020. University teaching hospital. Thirty-two female and four male dogs between 5 months and 5 years of age classified as ASA I undergoing elective desexing surgery. Urinalysis was performed preoperatively and 20-24 h postoperatively to identify markers of renal tubular injury (RTI), particularly the presence of granular and renal tubular epithelial cell (RTEC) casts on sediment analysis. Dogs underwent a full physical examination and a preoperative assessment including measurement of urine specific gravity (USG), packed cell volume (PCV), total plasma protein and serum creatinine (sCr) was conducted as a part of the desexing programme. Anaesthetic records were examined for any evidence of intraoperative hypotension, defined as a mean arterial pressure (MAP) of <60 mmHg for any duration of time. MAP was measured using an indirect oscillometric technique. For analysis, animals were subdivided into affected and nonaffected groups, with affected animals those that hadpostoperative increases in granular and RTEC casts. Categorical and comparative analyses were then performed between groups to identify associations of increased casts with pre-, intra- and postoperative variables. A frequency of RTI of 5.6% was identified. This was accompanied by a significant association between increases in casts with total duration (p = 0.027) and number (p = 0.016) of hypotensive episodes. RTI is an anaesthetic consideration in ASA I veterinary patients undergoing elective desexing surgery. The identification of an association between the total duration and number of hypotensive episodes and the frequency of RTI highlights the importance of early detection of hypotension along with prompt and effective intervention in veterinary patients.

Pregnancy-Associated Plasma Protein-A and Free β-Human Chorionic Gonadotrophin in Relation with Oxidative Stress in Obese Pregnant Women: A Clinical Cross-Sectional Study.

Background: The pathophysiological mechanism underlying pregnancy complications is not entirely known. Although it is currently impossible to predict the occurrence of redox imbalance, it is possible to identify women with a high or medium risk of developing this disease prior to a negative outcome by non-invasive diagnostic methods. The Aim: This study aimed to examine the possible role of the parameter of oxidative stress (OS) measured in early pregnancy in the screening/treatment of obesity and its complications during pregnancy. Methods: This research was designed as a prospective observational cross-sectional clinical study which included 40 non-obese and 31 obese pregnant women between 11 and 13 g.w. who were managed in the Department of Obstetrics, University Clinical Center Kragujevac in Serbia. We collected anthropometric and clinical indicators, maternal and pregnancy factors, and measured prooxidative parameters from blood samples. Results: We observed significantly increased levels of the superoxide anion radical, hydrogen peroxide and the index of lipid peroxidation in the Obese group in comparison with the Non-Obese group and significantly decreased bioavailability of nitrites in the Obese group in comparison with the Non-Obese group. Conclusions: The determination of systemic parameters of OS in early pregnancy could be a good methodological approach in the screening/treatment of obesity during pregnancy and this approach should be followed for the screening of endothelial dysfunction in pregnancy which needs further monitoring and/or treatment.

Early alterations of thalami- and hippocampi-cortical functional connectivity as biomarkers of seizures after traumatic brain injury

The Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBioS4Rx, project 3) is a prospective multicenter clinical observational study to identify early biomarkers of epileptogenesis after moderate-to-severe traumatic brain injury (TBI). We used a seed-based approach applied to acute (i.e., ≤14 days) fMRI imaging data, directly testing the hypothesis that the presence of seizures up to two years following brain trauma is associated with functional changes within hippocampi and thalami-cortical networks. Additionally, we hypothesized that the network connectivity involving thalami and hippocampi circuits underlying early and late-onset seizures would differ. Approximately 30% of the initial dataset was deemed unusable due to MRI issues. Approximately 50% of the enrolled sample was lost to a 2-year follow-up. After preprocessing the fMRI data, approximately 40% of the follow-up sample had to be excluded from the analysis due to excessive in-scanner movements, as assessed by state-of-the-art quality control protocols. Only 37 patients provided data that was suitable for the seed-based analysis. Despite these challenges, the remaining, high-quality data returned noteworthy findings. We identified specific hippocampi and thalami biomarkers associated with both early and late seizures following TBI (p < .05, FWE-corrected at the cluster level). The predictive capability for the development of late seizures after TBI, when adding fMRI data to demographic and clinical data, provided 88% accuracy — an additional 8% improvement compared to using demographic and clinical data alone. Our findings highlight the potential of fMRI for uncovering, in hippocampal and thalamic cortical networks, biomarkers of early and late seizures following TBI. However, they also highlight the important challenges that need to be overcome in order for fMRI to become an effective biomarker and prognostic tool in the intensive care context.

A New Suppression Index Calculation Using the Visually Enhanced Vestibulo-Ocular Reflex and Vestibulo-Ocular Reflex Suppression Paradigms in the Video Head Impulse Test.

This prospective observational clinical study includes 83 healthy subjects who underwent the head impulse and suppression tests (HIMP and SHIMP, respectively), qVVOR, and qVORS tests, all of the vHIT. The sinusoidal tests (qVVOR and qVORS) were conducted at an intended frequency of 0.75 Hz. The gains of these tests were calculated using a system specifically designed for this purpose. A formula for the SI was established using a ratio of the gains from these tests. Two SI values are presented: unilateral, distinct for each direction of head movement, and bilateral, representing the suppression of both sides simultaneously. Mean gains for the qVVORs were 0.981 ± 0.070 and 0.978 ± 0.077 for the rightwards and leftwards qVVORs, respectively. The gains for the suppressed tests were 0.334 ± 0.112 and 0.353 ± 0.110 for the rightwards and leftwards qVORSs, respectively. A difference of 0.05 Hz was observed between the expected (0.75 Hz) and the obtained frequency of head movement, which is statistically significant (p < 0.001). The SI was 0.342 ± 0.118 for the right side (right SI) and 0.363 ± 0.117 for the left side (left SI). The bilateral SI had a mean value of 0.295 ± 0.104. No significant differences in the SI were noted according to the subject's age. The SI for women was lower than in the case of males. The VVOR/VORS quantification algorithm allows for the reliable calculation of the numerical gain of qVVOR and qVORS with mathematical soundness and consistency of results. Our data support the use of a single or specific measure for direction of head movement; although significant differences exist, these differences are not clinically relevant.

Incidence of residual biologic debris and contamination of reused bipolar vessel sealing devices after ethylene oxide sterilization following splenectomy.

The aim of the present study was to quantify the amount of biologic debris present within disposable bipolar vessel sealing devices after each use for canine splenectomies and determine the aerobic bacterial load of the debris following instrument resterilization with ethylene oxide. Prospective observational clinical study. Client-owned dogs (n = 40) presenting to a single specialty hospital for open, routine, or emergency splenectomies. A total of 16 bipolar vessel sealing devices were randomly assigned to undergo one, two, three, or four splenectomies, manual hand cleanings, and ethylene oxide sterilizations before being dismantled. After final use and sterilization, each handset was agitated in phosphate-buffered saline before disassembly, which was submitted for aerobic culture. Following aseptic disassembly, all biological residue was photo-documented, collected, quantified using a subjective scoring system, and submitted for culture. Biologic debris was present within the inner mechanics of all devices, specifically under the blade used for vessel transection. A linear increase in debris was not appreciated amongst devices used once versus devices used multiple times. None of the devices nor any of the biologic debris cultured positive following sterilization with ethylene oxide. The presence of biologic debris was documented after the initial use of disposable bipolar vessel sealing devices, but no devices or debris yielded positive culture results following ethylene oxide sterilization after splenectomies. Increased risk of iatrogenic surgical site contamination from reused vessel sealing devices is unlikely when they have been cleaned and sterilized with ethylene oxide after up to four splenectomy surgeries.

A Modified McCall Culdoplasty in Pelvic Organ Prolapse Surgery: Anatomical and Functional Outcomes.

The aim of this study was to evaluate anatomical and functional outcomes of a modified McCall culdoplasty compared with the traditional technique for pelvic organ prolapse. This prospective clinical observational study was conducted in a secondary referral urogynecological center between October 2021 and October 2022. A modified McCall culdoplasty was performed in 85 patients (group A). It was characterized by dissection of uterosacral ligaments up to the ischial spines, their shortening and attachment to the vaginal apex and both the rectovaginal and the vesicovaginal fascia. Outcomes were compared with those of a group of 86 patients (group B) who underwent the traditional culdoplasty between September 2020 and September 2021. Primary outcome was prolapse recurrence. Secondary endpoints included subjective outcomes, vaginal length, quality of life, and urinary and anal incontinence. Statistical analysis was conducted using Fisher's exact, Mann-Whitney U, and Student's t tests. At 12months, prolapse recurrence occurred in 2.5% (CI 0.7-8.8%) of patients in group A and in 6.7% (CI 2.9-14.7%) in group B. Postoperative vaginal length was 8.3 ± 0.78cm in group A and 6.4 ± 1.1cm in group B (p < 0.001). The Patient Global Impression of Improvement questionnaire revealed that 76 patients (96.2%) in group A versus 64 (85%) in group B were very satisfied (p < 0.03). Both groups showed an improvement in urinary symptoms and quality of life. The modified McCall culdoplasty showed successful anatomical and functional outcomes, with a tendency towards lower recurrence rates than the traditional McCall procedure. Further long-term studies are needed to confirm our data.

Postoperative risk of bleeding after removal of third molars in healthy patients - a prospective observational clinical study

Removal of third molars in healthy patients is considered a procedure with a low risk of bleeding. However, exactly how low the incidence of postoperative bleeding is remains unclear due to the heterogeneity of available studies. To determine the exact postoperative risk of bleeding after the removal of third molars in healthy patients, a prospective observational multicentre study was conducted. A total of 1,035 patients with complete follow-up was included. Of these, 329 patients reported subsequent bleeding, but did not consult their attending physician. A total of 15 patients visited the hospital, 8 of whom required minimally invasive (re)treatment. No hospitalizations were necessary. There was a large difference between the incidence of postoperative bleeding reported by patients and postoperative bleeding requiring clinical examination and/or treatment. To reduce this difference in future, patients should be given detailed information about what degree of postoperative bleeding is considered normal after removal of a third molar.

Effects of Capnoperitoneum on Liver Functions: A Comparison Between Biliary and Non-Biliary Laparoscopic Surgeries.

Background: Laparoscopic procedures done using capnoperitoneum causes altered enzyme activity, which is subclinical most of time hence goes undiagnosed, leading to life threatening complications in patients with compromised hepatic function. Studies on altered hepatic enzyme activity has been done on patients undergoing laparoscopic cholecystectomy and seldom on laparoscopic non biliary surgeries, which we encounter daily. Hence aim of study was to compare effects of capnoperitoneum on liver functions in biliary and non-biliary surgeries.Methods: This prospective clinical observational study was conducted after obtaining institutional ethical clearance. Study was done on 60 patients undergoing surgeries. They were divided into two groups biliary and non-biliary based on undergoing surgeries. Patients blood sample was collected preoperatively and 24 hours postoperative for accessing liver enzymes. Statistical analysis done using SPSS version 23. Shapiro- wilk, paired ‘t’and chi- square tests were used to analyse the data. P &lt; 0.05 considered statistically significant.Results: The comparative parameters liver enzymes done pre and post operatively in biliary group total bilirubin, direct bilirubin, alkaline phosphatase, total protein, albumin and in non-biliary group aspartate transaminase, alkaline phosphatase, total protein, albumin were statistically significant.Conclusion: Post operative elevation in liver enzymes was found in both biliary and non biliary surgeries but enzymes specific to liver injury was found in biliary group.

Effect of scapular posterior tilting exercise on scapular muscle activities in men and women with a rounded shoulder posture

Round-shoulder posture (RSP) is a common postural condition, characterized by protraction, downward rotation, anterior tilting and internal rotation of the scapula. RSP can lead to shoulder dysfunction. Different methods have been proposed for rehabilitating and correcting the altered posture in RSP including stretching, strengthening exercises, and shoulder brace or taping. However, the findings are controversial and studies are ongoing to develop more effective method. The present study is aimed at investigating the effects of scapular posterior tilting (SPT) exercise in different support positions on scapular muscle activities in men and women with RSP. In a prospective observational clinical study, we assessed demographic, basic clinical parameters and study variables of the subjects with RSP (n = 20) (men/women = 9/11) attending Daegu University in Gyeongsan, South Korea. To do so, we compared electromyographic (EMG) activities of lower trapezius and serratus anterior muscles between men and women with RSP during SPT exercise on four different support surfaces to determine any difference in the EMG activities. The results revealed that women showed significant differences in EMG activities in the lower and left upper trapezius and serratus anterior muscles, while men showed significant differences in EMG activity only in the lower trapezius muscle during SPT exercise on four different surfaces (P < 0.05). The post-hoc analysis revealed significantly greater EMG activity values in the lower trapezius and serratus anterior muscles during SPT exercise on the upper body unstable surface and whole-body unstable surface (p < 0.05). Independent t-tests after the Bonferroni correction showed no significant differences in muscle activities between men and women on the four different surfaces (p > 0.0125).

Current Diagnostic and Therapeutic Approaches in May-Thurner Syndrome in Children, Adolescents, and Young Adults: A Survey among Thrombosis Experts of the German Society of Thrombosis and Haemostasis.

May-Thurner syndrome (MTS) is a pelvic venous disorder involving compression of the left common iliac vein by the right common iliac artery, which results in predisposition for deep vein thrombosis. Although MTS is increasingly recognized in young patients, specific guidelines on diagnosis and management for children, adolescents, and young adults do not exist so far. The aim of this study was to assess current diagnostic and therapeutic practice in Germany, Austria, and Switzerland in children and young adults with thrombosis and MTS.We designed an online survey with 11 questions, which we sent via a mailing list to all members of the German, Austrian, and Swiss Society of Thrombosis and Haemostasis Research. Between July and October 2022, 33 specialists answered the questionnaire. Most participating specialists worked at pediatric hospitals (61%). Numbers of annually treated thromboses ranged from <5 (26%) to >30 (13%). Most specialists used venous ultrasound to diagnose deep vein thrombosis, 53% magnetic resonance imaging. Only 25% of specialists systematically screened for MTS in deep vein thrombosis. MTS was managed with anticoagulation (65%), iliac vein stent placement (32%), or balloon angioplasty (13%). In total, 31% of specialists reported to use more than one therapeutic method. Diagnostic and therapeutic approaches for MTS differed between specialists. Lack of standardization resulted in individualized and highly diverse management. Prospective observational clinical studies investigating the outcome of different management strategies including long-term follow-up on outcome and incidence of postthrombotic syndrome will help in defining patient groups who benefit most from revascularizing interventional strategies and developing standardized guidelines.

ВОЗМОЖНОСТИ ТЕРАПИИ КАШЛЯ У ДЕТЕЙ

Acute respiratory infections (ARI) are the main reason for morbidity in childhood. In ca. 90% of cases, they are accompanied by cough. The purpose of this research was to study the effectiveness and safety of the STODAL® drug in the treatment of cough in children. Materials and methods used: a multicenter prospective observational non-randomized clinical study was conducted involving 1000 outpatients with ARI aged 2 to 7 y/o and whose cough duration did not exceed 3 days from the onset of the disease. All of them were prescribed and treated with the complex homeopathic anticough drug on the day of their visit to pediatric practitioner in the outpatient hospital facilities. The patients were divided into two age groups as follows: G1 (n=500) of children aged 2 to 4 y/o and G2 (n=500) of children aged 4 years and 1 day old to 7 y/o. Results: on the 7th day of the therapy, a statistically significant decrease in the severity of daytime cough was noted: in G1 the severity of cough decreased by 1.51 points (from 2.16 to 0.65 points, p&lt;0.001) and by 1.56 points (from 2.24 to 0.68 points, p&lt;0.001) in G2. There was no difference in the reduction in daytime cough severity between the groups (p=0.158). The severity of night cough in G1 decreased by 1.16 points (from 1.64 to 0.48 points, p&lt;0.001) and by 1.25 points (from 1.71 to 0.46 points, p&lt;0.001) in G2. There were no differences in the dynamics of the severity of night cough between the groups as well (p=0.135). The proportion of patients whose cough resolved completely or became clinically insignificant on the 7th day of treatment was 98%, these patients were therefore considered recovered. Cough treatment was rated positively by 95.1% of parents/caretakers. Adverse events (AEs) were reported in 5 patients (0.5% of all cases) and there were no serious AEs among them. Conclusion: the effectiveness and safety of the STODAL® drug in the treatment of cough in ARI in children aged 2 to 7 y/o allows recommending a homeopathic drug with complex anti-inflammatory, antitussive and antimicrobial action for its inclusion in the treatment regimens starting from the first days of the disease.

Impact of chemotherapy-induced peripheral neuropathy permanence on patients' preference to discontinue chemotherapy.

12046 Background: Chemotherapy-induced peripheral neuropathy (CIPN) diminishes patients’ functional ability and quality of life; approximately 40% of patients experience CIPN symptoms 3 years after treatment. Due to the absence of effective CIPN treatments, ASCO guidelines recommend discontinuing chemotherapy in patients experiencing intolerable CIPN symptoms. Little is known about patient’s preference to continue or discontinue chemotherapy when experiencing CIPN, and whether the potential permanence of CIPN symptoms affects this decision. The objective of this prospective observational study was to determine the effect of CIPN symptom permanence on patients’ preference to discontinue chemotherapy. Methods: Patients receiving taxane and/or platinum chemotherapy for breast or colorectal cancer were enrolled in a prospective observational clinical study. Patients reported their CIPN severity using the EORTC CIPN20 patient-reported outcome questionnaire at the start of each treatment cycle. At the same time, patients were asked if they would prefer to continue or discontinue chemotherapy treatment under the hypothetical scenario that their current CIPN symptoms would be temporary or permanent. A generalized linear mixed effects model was used to determine the effect of CIPN severity, permanence, and other clinical variables on a patient’s decision to discontinue (vs. continue) chemotherapy treatment. Results: A total of 66 patients completed data collection at least one time, of whom 55 (83%) had breast cancer, 12 (18%) had metastatic disease, and 52 (79%) received a taxane. The odds a patient would prefer to discontinue chemotherapy treatment if their CIPN symptoms would be permanent (vs. temporary) were nearly 30 times greater (odds ratio (OR)=30.15, 95% confidence interval (CI): 15.73-57.79, p&lt;0.001, Table). There was a statistical trend toward preferring to discontinue chemotherapy treatment as CIPN symptom severity increased (OR=1.09, 95% CI: 1.00-1.19, p=0.063). Conclusions: The potential for CIPN symptoms to be permanent has a huge effect on whether patients want to continue or discontinue chemotherapy treatment. Additional data is needed on the incidence and predictors of permanent CIPN. More importantly, shared decision-making tools that convey the risk of permanent CIPN, and the potential risk of discontinuing chemotherapy treatment, are needed to facilitate patient-centered treatment decisions so that each patient with cancer achieves their personal treatment goals. [Table: see text]

LONG-TERM CLINICAL RESULTS OF HALLUX VARUS CORRECTION BY A REVERSED ABDUCTOR HALLUCIS TRANSFER

BackgroundIatrogenic hallux varus is a rare complication after hallux valgus surgery. Operative treatment comprises a wide variety of techniques, of which the reversed transfer of the abductor hallucis tendon is the most recent described technique.MethodsThis paper will present the long-term clinical results of the reversed transfer of the abductor hallucis longus. Therefore, we performed a prospective clinical observational study on 16 female patients. Our hypothesis is that the tendon transfer will persist in a good alignment and patient satisfaction on long term. There is a 100% follow-up rate with a range from 10 to 101 months. Patients were subjected to a clinical examination, three questionnaires and their general satisfaction.ResultsOut of 16 patients, at time of follow-up, we found a positive correlation between the subjective outcome score and alignment (r = 0.59), and between the general satisfaction and alignment (r = 0.77). Based on the general satisfaction we achieved a success satisfaction rate of 69% (11 patients). The other 31% (5 patients) patient group was only satisfied with major reservations or not satisfied at all. The two most invalidating complications were a coronal or sagittal malalignment or the combination of both.ConclusionOur results suggest that the reverse abductor hallucis tendon transfer is a good technique to treat a supple iatrogenic hallux varus with an observed success satisfaction rate of 69% at a mean follow-up time of 48 (range 10–101) months. However, patients should be informed that on the long-term loss of correction is possible.

Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance and feasibility of the Genital InFlammation Test (GIFT)

IntroductionA prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test—called the Genital InFlammation Test (GIFT)—for detecting genital inflammation associated with sexually...

'Monkeypox 2.0': Case series on a reconditioned virus causing sexually transmissible disease in urban population.

MPOX (Monkeypox) viral infection, a zoonotic disease previously confined to the African sub-continent, has caught attention worldwide recently due to its resurgence in a new 'avatar' among urban communities. Dermatologists in the U. A. E. started to see patients with fever and a self-limiting pustular necrotic rash that was negative for all other infectious investigations. We performed a prospective observational multicenter clinical study of the demographics, skin manifestations, and outcomes of patients presenting with necrotic pustular lesions and/or fever. 35 cases of PCR confirmed MPOX cases, mostly in the expatriate population, were followed up and found to have high-risk heterosexual contact on an average of 1week prior to disease onset. We found that they have characteristic annular pustular lesions with necrotic center or "Smoke ring pustules' in all cases. Lesion tenderness and predilection for the lower abdomen, pubic area, and genitalia were observed. Most cases were systemically stable, with fever lasting for an average of 4days and elevated CRP levels. Genital lesions were prone to secondary bacterial infections. The disease was severe, with larger annular plaques in one of our patients found to be living with HIV. The overall prognosis in healthy individuals is good, with lesions healing within an average of 2weeks without scarring. 'New world MPOX' should be unclassified from zoonosis to a sexually transmitted infection (STI) capable of transmission in an urban population. Our findings can help in early clinical suspicion and differentiation from other STI's for primary and secondary health care physicians.

Exploring vascular contributions to cognitive impairment and dementia (ENIGMA): protocol for a prospective observational study

BackgroundPost-stroke cognitive impairment (PSCI) is common. However, the underlying pathophysiology remains largely unknown. Understanding the role of microvascular changes and finding markers that can predict PSCI, could be a first step towards better screening and management of PSCI. Capillary dysfunction is a pathological feature of cerebral small vessel disease and may play a role in the mechanisms underlying PSCI. Extracellular vesicles (EVs) are secreted from cells and may act as disease biomarkers. We aim to investigate the role of capillary dysfunction in PSCI and the associations between EV characteristics and cognitive function one year after acute ischemic stroke (AIS) and transient ischemic attack (TIA).MethodsThe ENIGMA study is a single-centre prospective clinical observational study conducted at Aarhus University Hospital, Denmark. Consecutive patients with AIS and TIA are included and followed for one year with follow-up visits at three and 12 months. An MRI is performed at 24 h and 12 months follow-up. EV characteristics will be characterised from blood samples drawn at 24 h and three months follow-up. Cognitive function is assessed three and 12 months after AIS and TIA using the Repeatable Battery for the Assessment of Neuropsychological Status.DiscussionUsing novel imaging and molecular biological techniques the ENIGMA study will provide new knowledge about the vascular contributions to cognitive decline and dementia.Trial registrationThe study is retrospectively registered as an ongoing observational study at ClinicalTrials.gov with the identifier NCT06257823.

A Novel Therapeutic Approach of 980 nm Photobiomodulation Delivered with Flattop Beam Profile in Management of Recurrent Aphthous Stomatitis in Paediatrics and Adolescents-A Case Series with 3-Month Follow-Up.

Background/Objectives: Recurrent aphthous stomatitis (RAS) is one of the most common oral mucosal lesions and a very debilitating lesion, especially in paediatric and adolescent patients. The current pharmacotherapy offers a pain relief but not without side effects, and therefore photobiomodulation (PBM) can be an alternative therapy. To the authors' best knowledge, no published study has explored the efficacy of λ 980 nm laser PBM in the management of all RAS subtypes in paediatric and adolescent patients, and therefore, this prospective observational clinical study was conducted to bridge this gap by evaluating λ 980 nm laser PBM efficacy in symptomatic RAS management in paediatric and adolescent patients. The objectives were to evaluate (1) pain intensity alleviation; (2) wound healing rate; (3) wound size closure; (4) a complete resolution; (5) evidence of recurrence; and (6) patients' treatment satisfaction. Methods: The study's variables were assessed at the following timepoints: T0: pre-treatment; T1: immediately after first PBM session; T2: 5 hours (h) post first PBM session (via telephone call); T3: immediately after second PBM session (three days post first PBM session); T4: three-day follow-up (after complete PBM treatments); T5: two-week follow-up; and T6: three-month follow-up. The following PBM dosimetry and treatment protocols were employed: λ 980 nm; 300 mW; 60 s; 18 J; CW; flattop beam profile of 1 cm2 spot size; 18 J/cm2; and twice-a-week irradiation (72 h interval). Results: At T1, significant immediate pain intensity relief was reported. 33.33% recorded "4" and 66.67% reported "5" on the quantitative numeric pain intensity scale (NPIS), and this continued to improve significantly (83.33%) at T2. All the subjects reported "0" on the NPIS at T3, T4, T5 and T6. There was a significant reduction in the lesion surface area (>50% complete healing) at T3 compared to T0. Complete healing (100%) with no evidence of scarring and lesion recurrence observed at T4, T5 and T6. Very good patients' satisfaction was reported at all timepoints. Conclusions: This is the first report demonstrating λ980 nm efficacy in all RAS subtype management in paediatric and adolescent patients with a 3-month follow-up, whereby its PBM dosimetry and treatment protocols were effective from scientific and practical standpoints, and hence multicentre RCTs with large data are warranted to validate its reproducibility and to enrich the knowledge of PBM application in all RAS subtypes.

Neutrophil-to-Lymphocyte Ratio and Blood Eosinophil Levels As Inflammatory Indicators in Smoker and Non-smoker Young Adult Patients With Chronic Obstructive Pulmonary Disease at a Tertiary Care Hospital.

Background Inflammatory markers are elevated in chronic obstructive pulmonary disease (COPD) and can be quantified to detect severity, prognosis, mortality risk, and response to treatment. However, the estimation costs are high. The blood neutrophil-to-lymphocyte ratio (NLR) and eosinophil levels are emerging as biomarkers in COPD, yet there is a paucity of data. Aim and objectives This study was designed to elucidate the roles of the NLRand eosinophil levels in smokers and non-smokers with stable COPD male subjects, correlating them with lung functions. Materials and methods A prospective observational clinical study was conducted from January to June 2023, after receiving approval from the Institutional Ethics Committee, on 73 COPD patients aged 30-60 years who gave voluntary informed consent. Complete blood counts and spirometry were performed. Patients with a forced expiratory volume in one second(FEV1) % predicted <70% and an FEV1/forced vital capacity (FVC) % <70% based on the pulmonary function test (MIR Spirolab) were included. They were further divided into mild (n=10), moderate (n=27), severe (n=26), and very severe (n=10) categories as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines. Subjects were also categorized into smoker (n=45) and non-smoker (n=28) groups. The complete blood count was analyzed using an automated analyzer (Beckman Coulter). Analysis was also carried out with an NLR of more or less than three. A P-value of less than 0.05 was considered significant. Results Smokers constituted 61.65% (n=45) of the subjects, and non-smokers 38.35% (n=28). Among smokers, 17.78% had very severe airflow obstruction. In all COPD subjects (n=73), lymphocytes, eosinophils, and lung functions were lower in the group where the NLR was greater than three. NLR in smokers (3.52±1.43) was higher than in non-smokers (3.39±0.94). In non-smokers (n=28), blood eosinophils and lymphocytes were elevated. In smokers (n=45), blood neutrophils, monocytes, and basophils were increased. Smokers showed a non-significant increase in RBC, mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH). Neutrophils, monocytes, eosinophils, and NLR increased with disease severity. NLR negatively correlated with FEV1 (r=-0.350, p=0.034) and positively with pack-years (r=0.546, p<0.001) in smokers. NLR negatively correlated with eosinophils, FVC, FEV1/FVC, and FEV1 % predicted. In all COPD subjects (n=73), NLR negatively correlated with blood eosinophils (r=-0.184, p=0.12), BMI, and lung functions. Conclusion NLR is elevated in COPD subjects and can serve as a marker of inflammation and a predictor of the risk and severity of airflow limitation. NLR correlates both positively and negatively with pack-years and lung functions, respectively.

Serum vitamin D is substantially reduced and predicts flares in diabetic retinopathy patients.

Research has suggested that vitamin D deficiency is associated with diabetic retinopathy (DR). Our study aimed to determine whether vitamin D deficiency is the cause of diabetic retinopathy or if diabetic retinopathy reduces vitamin D levels. Participants with type-2 diabetes were recruited for this prospective observational clinical study and were divided into a diabetic group without retinopathy and a diabetic group with retinopathy, with additional healthy volunteers serving as a control group. The differences in clinical characteristics among the three groups were also compared. Patients without retinopathy were then followed for 1 year to monitor the incidence of diabetic retinopathy. After follow-up, participants were divided into subgroups based on whether diabetic retinopathy occurred. The baseline data of the subgroups were compared, and the independent risk factors were analyzed. Vitamin D levels were generally low. Participants with diabetic retinopathy had significantly lower vitamin D levels than did those without retinopathy (P < 0.01). A comparison of the two subgroups revealed lower baseline vitamin D concentrations in the new-DR subgroup than in the non-DR subgroup (P < 0.01). Vitamin D deficiency and elevated HbA1c levels were found to be independent risk factors for diabetic retinopathy (OR = 0.935, 95% CI: 0.867-0.981, P = 0.006; OR = 2.208, 95% CI: 1.764-2.764, P < 0.01). The limit of vitamin D intake according to the receiver-operating characteristic (ROC) curve was 26.01 ng/mL, and the area under the ROC curve was 0.603 (95% CI: 0.559-0.706, P = 0.002). Vitamin D levels were significantly lower in patients diagnosed with diabetic retinopathy. More importantly, vitamin D deficiency may accelerate the onset of diabetic retinopathy.