Single-center Pilot Study Research Articles

Clinical evaluation of combined autologous Platelet-Rich Plasma and Volume-Controlled Ozone Therapy in Facial Rejuvenation: A randomized controlled Pilot Study.

Platelet rich plasma and ozone therapy have been suggested in the clinical setting as promising and adjuvant therapies for managing the symptoms related to the facial aging. However, there is a lack of evidence about the effects of combining both therapies on rejuvenation. Thus, the aim of the present study was to evaluate and to compare the safety and efficacy of both therapies in facial aging. A single-center prospective pilot study was conducted. Female participants, aged 40 to 60 years, were randomized into 2 groups: participants received the platelet rich plasma treatment (PRP); participants received the therapy with platelet rich plasma associated with ozone therapy (PRPOT). Interventions were performed using the facial intradermal technique in 42 pre-established points, for 4 sessions with an interval of 15 days between them. After analyses performed using photographic records, assessment of frontal, periorbital, nasolabial and marionette wrinkles (Wrinkle Assessment Scale), self-esteem assessment (Brazilian Version of Rosenberg's Self-Esteem Scale) and assessment of patient satisfaction (FACE-Q) can be suggested that the platelet rich plasma protocol performed in the present study, as well as its association with volume-controlled ozone therapy, proved to be safe and potentially promising modalities in the treatment of facial aging.

A phase Ib study to assess the safety of the human papillomavirus DNA vaccine (AMV002) in combination with durvalumab for HPV-associated oropharyngeal squamous cell carcinoma.

Programmed cell death ligand 1 (PD-L1) inhibitors have limited efficacy as monotherapy in patients with recurrent/metastatic (R/M) Human Papilloma Virus (HPV) oropharyngeal squamous cell carcinoma (OPSCC). A phase I study of the therapeutic HPV-16 DNA vaccine AMV002 in curatively treated patients with OPSCC demonstrated a measurable immune response against HPV while being associated with high safety and tolerability. This prospective phase Ib single centre pilot study aims to test the safety and tolerability of combined PD-L1 inhibitor, Durvalumab, with AMV002 in 12 patients with recurrent OPSCC. Participants had evidence of R/M HPV-associated OPSCC. They received three intradermal administrations of AMV002 with Durvalumab followed by Durvalumab maintenance. Safety and tolerability data was the primary endpoint. The study was conducted with ethical approval (HREC/2018/QMS/47293) in Brisbane, Australia. The most common adverse event (AE) related to vaccine administration was erythema at the injection site. There were no grade 3 or 4 vaccine related AEs. There was one presumed immune-related grade 3 elevation in lipase secondary to Durvalumab with no intervention required. No patient ceased study due to treatment-related AEs. At week 16, objective response rate was 8% (N=1) and disease control rate was 17% (N=2). At a median follow up of 25.6 (20.0-26.6) months there was one long term complete response while all other participants developed progressive disease. Of the 11 evaluated patients, 9, (82%) had E6 and/or E7-specific T cell responses to the vaccine. The combination of AMV002 therapeutic HPV-16 vaccine and Durvalumab was found to be safe and well tolerated with no increased safety signals generated. T cell responses to vaccine were observed but further work will be required to improve efficacy.

Development of a Miniaturized Mechanoacoustic Sensor for Continuous, Objective Cough Detection, Characterization and Physiologic Monitoring in Children With Cystic Fibrosis.

Cough is an important symptom in children with acute and chronic respiratory disease. Daily cough is common in Cystic Fibrosis (CF) and increased cough is a symptom of pulmonary exacerbation. To date, cough assessment is primarily subjective in clinical practice and research. Attempts to develop objective, automatic cough counting tools have faced reliability issues in noisy environments and practical barriers limiting long-term use. This single-center pilot study evaluated usability, acceptability and performance of a mechanoacoustic sensor (MAS), previously used for cough classification in adults, in 36 children with CF over brief and multi-day periods in four cohorts. Children whose health was at baseline and who had symptoms of pulmonary exacerbation were included. We trained, validated, and deployed custom deep learning algorithms for accurate cough detection and classification from other vocalization or artifacts with an overall area under the receiver-operator characteristic curve (AUROC) of 0.96 and average precision (AP) of 0.93. Child and parent feedback led to a redesign of the MAS towards a smaller, more discreet device acceptable for daily use in children. Additional improvements optimized power efficiency and data management. The MAS's ability to objectively measure cough and other physiologic signals across clinic, hospital, and home settings is demonstrated, particularly aided by an AUROC of 0.97 and AP of 0.96 for motion artifact rejection. Examples of cough frequency and physiologic parameter correlations with participant-reported outcomes and clinical measurements for individual patients are presented. The MAS is a promising tool in objective longitudinal evaluation of cough in children with CF.

COLODETECT 1: comparative evaluation of endocuff with computer-aided detection versus computer-aided detection alone versus standard colonoscopy for enhancing adenoma detection rates during screening colonoscopy—a pilot study

Background: Independent use of artificial intelligence with computer-aided detection (CADe) and Endocuff Vision (ECV) has demonstrated enhanced adenoma detection rates (ADRs). Objective: Our pilot study aimed to define the necessary participant number for future randomized controlled trials (RCTs) by comparing the ADR of combined CADe + ECV against CADe alone and standard colonoscopy. Design: This single-center pilot study retrospectively analyzed a prospectively maintained database, where patients underwent screening colonoscopies sequentially by standard method, CADe alone, and then CADe + ECV. Method: The allocation of the technique depended on the study period. Patients were randomly selected from the cohort to form three groups of 30 patients, with stratification based on factors influencing the ADR. The primary endpoint was the ADR. Results: From April to June 2021, 244 patients underwent screening colonoscopy. 198 were eligible, and after randomization, 90 patients were included across three groups (colonoscopy n = 30, CADe n = 30, CADe + ECV = 30). The ADR was higher in the CADe + ECV group compared to the CADe and colonoscopy groups: 60% versus 40%, and 30%, respectively ( p = 0.03). The number of polyps ⩽3 mm detected was greater in the CADe + ECV group ( n = 23) versus CADe ( n = 7) and colonoscopy ( n = 12) groups, respectively ( p = 0.03). CADe + ECV identified more polyps in the cecum/right colon ( n = 26) compared to CADe ( n = 18) and colonoscopy ( n = 12) groups ( p = 0.04), and in the left colon/sigmoid ( n = 14) compared to CADe ( n = 5) and colonoscopy ( n = 2) ( p = 0.02). Conclusion: These findings underscore the synergic potential of combining CADe with ECV to enhance ADR and enable us to perform sample size calculations for future RCTs. Registration: Clinical Trials number: NCT05080088. Registration 06/06/2021.

Is target-controlled infusion better than manual controlled infusion during TIVA for elective neurosurgery? Results of a single-centre pilot study.

Maintaining optimal systemic circulatory parameters is essential to ensure adequate cerebral perfusion (CPP) during neurosurgery, especially when autoregulation is impaired. To compare two types of total intravenous anaesthesia i.e. target controlled infusion (TCI) and manually controlled infusion (MCI) with propofol and remifentanil in terms of their control of cardiovascular parameters during neurosurgical resection of intracranial pathology. Patients with supratentorial intracranial pathology were selected for the study. Patients in ASA grades III and IV and those with diseases of the circulatory system were excluded. Patients were randomly divided into two equal groups according to the method of general anaesthesia used i.e. TCI or MCI. During the neurosurgery, the values of mean arterial pressure (MAP), heart rate (HR), bispectral index (BIS) and central venous pressure were monitored and recorded at the designated 14 relevant (i.e. critical from the anaesthetist's and neurosurgeon's points of view) measurement points. Fifty patients (25 TCI and 25 MCI) were enrolled in the study. The groups did not differ with respect to sex, age and BMI, operation time or volume of removed lesions. TCI-anaesthetised patients had better MAP stability at the respective time points. Due to the greater stability of MAP, which has a direct effect on CPP, TCI appears to be the method of choice in anaesthesia for intracranial surgery.

1H magnetic resonance spectroscopy in the differentiation between low- and high-grade cervical carcinoma: is it efficient?

To evaluate the extent to which magnetic resonance spectroscopy (MRS) lipid metabolites are accurate in predicting high-grade cervical cancer. This prospective single-centre pilot study included 20 cases with pathologically proven cervical cancer. They underwent pelvic magnetic resonance imaging (MRI) with MRS. Two radiologists, blinded to the histopathological results, with 10 years of experience in gynaecological imaging, independently analysed the MRI images and MRS curves, and a third one resolved any disagreement. Using the histopathological results as a standard test, the receiver operating characteristics (ROC) curve was utilised to calculate the optimal lipid peak (1.3 ppm) cutoff for predicting high-grade cervical cancer. The difference in MRS metabolites between low- and high-grade cervical cancer groups was estimated using the Mann-Whitney test. The study included 11 high-grade and nine low-grade cervical cancer cases based on the histopathological evaluation. A lipid (1.3 ppm) peak of 29.9 was the optimal cutoff for predicting high-grade cervical cancer with 100% sensitivity, 77.8%, specificity, and 90% accuracy. Moreover, there was a significant difference between low- and high-grade cervical cancer cases concerning lipid peak at 0.9 ppm, lipid peak at 1.3 ppm, and the peak of choline with (p-value 0.025, 0.001, and 0.023), respectively. MRS might be considered a useful imaging technique for assessing the grade of cervical cancer and improving the planning of treatment. It shows a good diagnostic accuracy. Therefore, it can be adopted in clinical practice for better patient outcome.

Results of evaluation of neurometabolic and rehabilitation therapy for vincristine polyneuropathy in children with acute lymphoblastic leukemia

Introduction. Vincristine-induced peripheral neuropathies (VIPN) is a current problem in the management of pediatric acute lymphoblastic leukemia (ALL). There are no effective therapeutic strategies for VIPN. The aim of the study to present the results of evaluation of neurometabolic therapy in the acute period of VIPN in children with ALL and the method of virtual rehabilitation in the recovery period. Materials and methods. The single-center prospective comparative pilot study involved 69 children with VIPN who were treated in the acute period with the following drugs: group 1 - pyridoxine, group 2 - thioktovic acid, group 3 - inosine + nicotinamide + riboflavin + succinic acid. Clinical and electrophysiological parameters before and after drug treatment were analyzed. Among 10 children with motor deficits in the lower extremities in the recovery period of VIPN, rehabilitation with immersive virtual reality was performed, and the clinical parameters before and after the course were compared. Results. A positive effect of the studied drugs on the clinical condition of patients by the 30th day of therapy was revealed. In groups 1 and 3 the total score on the NIS-LL scale correlated with mild polyneuropathy - 4 [2÷8] and 2 [2÷6] points, respectively. Neurologic impairment in each of these groups persisted for 19 [14÷25] and 19 [13÷30] days, which was less in contrast to the duration of symptoms in group 2 (p1-2 = 0.021 and p2-3 = 0.046). In the VIPN recovery period before and after virtual rehabilitation: muscle strength in the lower limbs increased (p = 0.025); the severity of polyneuropathy decreased according to the NIS-LL scale (p = 0.003); balance improved according to the Berg scale (p = 0.017); and patients’ mobility increased according to the Functional Walking Category test (p = 0.025) and walking speed according to the time-recorded walking test (p = 0.008). Discussion. Improvement of clinical parameters with neurometabolic therapy and virtual rehabilitation in children with VIPN has been shown. Conclusion. Preliminary results of the effectiveness of pyridoxine and inosine + nicotinamide + riboflavin + succinic acid in the acute period of VIPN in children with ALL and the method of virtual rehabilitation in the recovery period were obtained.

Breath-Hold-Triggered BOLD fMRI in Drug-Resistant Nonlesional Focal Epilepsy-APilot Study.

Individuals with drug-resistant epilepsy may benefit from epilepsy surgery. In nonlesional cases, where no epileptogenic lesion can be detected on structural magnetic resonance imaging, multimodal neuroimaging studies are required. Breath-hold-triggered BOLD fMRI (bh-fMRI) was developed to measure cerebrovascular reactivity in stroke or angiopathy and highlights regional network dysfunction by visualizing focal impaired flow increase after vasodilatory stimulus. This regional dysfunction may correlate with the epileptogenic zone. In this prospective single-center single-blind pilot study, we aimed to establish the feasibility and safety of bh-fMRI in individuals with drug-resistant non-lesional focal epilepsy undergoing presurgical evaluation. In this prospective study, 10consecutive individuals undergoing presurgical evaluation for drug-resistant focal epilepsy were recruited after case review at amultidisciplinary patient management conference. Electroclinical findings and results of other neuroimaging were used to establish the epileptogenic zone hypothesis. To calculate significant differences in cerebrovascular reactivity in comparison to the normal population, bh-fMRIs of 16healthy volunteers were analyzed. The relative flow change of each volume of interest (VOI) of the atlas was then calculated compared to the flow change of the whole brain resulting in an atlas of normal cerebral reactivity. Consequently, the mean flow change of every VOI of each patient was tested against the healthy volunteers group. Areas with significant impairment of cerebrovascular reactivity had decreased flow change and were compared to the epileptogenic zone localization hypothesis in asingle-blind design. Acquisition of bh-fMRI was feasible in 9/10cases, with one patient excluded due to noncompliance with breathing maneuvers. No adverse events were observed, and breath-hold for intermittent hypercapnia was well tolerated. On blinded review, we observed full or partial concordance of the local network dysfunction seen on bh-fMRI with the electroclinical hypothesis in 6/9cases, including cases with extratemporal lobe epilepsy and those with nonlocalizing 18F-fluorodeoxyglucose positron emission tomography (FDG-PET). This represents the first report of bh-fMRI in individuals with epilepsy undergoing presurgical evaluation. We found bh-fMRI to be feasible and safe, with apromising agreement to electroclinical findings. Thus, bh-fMRI may represent apotential modality in the presurgical evaluation of epilepsy. Further studies are needed to establish clinical utility.

A Feasibility Study Evaluating Von Willebrand Factor in Patients with Gastrointestinal Angiodysplasia

Background: Abnormalities of von Willebrand Factor (VWF), such as those found in von Willebrand Disease (VWD) are associated with the development of abnormal blood vessels known as angiodysplasia. Angiodysplasia occurs primarily in the gastrointestinal (GI) tract, particularly the small bowel. Among patients with VWD, angiodysplasia is significantly overrepresented as a cause of GI bleeding and occurs in all VWD subtypes although it is reported more frequently in those with loss of the high molecular weight multimer of VWF. Recent studies have demonstrated more than a third of patients with VWD and GI bleeding have angiodysplasia when systematically assessed with Video Capsule Endoscopy (VCE) to examine the small bowel. Given the relationship between angiodysplasia and VWD our objective was to assess the feasibility of evaluating patients with GI angiodysplasia for abnormalities of VWF. Methods: We undertook a prospective single center pilot study to assess patients over the age of 18 with GI angiodysplasia for underlying abnormalities of VWF. Patients were identified based on angiodysplasia being present on a VCE study. Patients who consented to enrollment completed a self-administered bleeding assessment tool (BAT) as well as baseline demographic data. VWF testing included VWF antigen (VWF:Ag), VWF functional assay (VWF:GPIbM), Factor VIII coagulant activity (FVIII:C), and VWF pro-peptide (VWFpp) levels. Results: After reviewing 190 consecutive VCE studies performed at our institution between April 2021 and April 2023, we identified 50 patients who had capsule endoscopies demonstrating angiodysplasia of the GI tract. Thirteen of these patients consented to enrollment in the study. The bleeding histories of included patients are detailed in Table 1 along with their baseline clinical, laboratory, and demographic data. Two patients endorsed lifelong bleeding symptoms and three reported a significant family history of bleeding - all in a female relative. ISTH-BAT scores ranged from 0 to 18 with a median score of 2. Since our population is older than other studies that report on bleeding scores, we considered an abnormal bleeding score to be >6 as recent evidence indicates normal BAT scores increase over time. Five patients (38.6%) in our study had an ISTH-BAT abnormal bleeding score. VWF levels were assessed (Table 1) and one patient aged 88 years old with a significant family and lifelong history of bleeding received a new diagnosis of Type 2A VWD. Severe iron deficiency anemia requiring ongoing IV iron was diagnosed in two patients. Conclusion: In our feasibility study, we demonstrated a feasible protocol for recruitment of patients with GI angiodysplasia for clinical and laboratory testing of VWF. A significant proportion of our patients (38.6%) had abnormal bleeding scores and one patient had an underlying Type 2A VWD diagnosis.

Non-compressive sleeves versus compression stockings after total knee arthroplasty: A prospective pilot study

BackgroundCompression stockings are routinely prescribed after total knee arthroplasty (TKA). Non-compressive sleeves embedded with semiconductor elements (Incrediwear) are designed to enhance blood flow. The objective of this investigation is to compare compression stockings and Incrediwear on post-TKA measures. MethodsIn this single-center prospective clinical pilot study, patients undergoing TKA were assigned to either the compression stocking (control) or Incrediwear (experimental) group. Subjects were evaluated preoperatively and postoperative at 3 weeks for pain, knee effusion, knee range of motion (ROM), thigh and calf circumferences. ResultsIncrediwear subjects had slightly higher preoperative effusion than controls (mean effusion 1.38 vs. 1.16, p = .28); however, by week 3, Incrediwear subjects had lower levels of effusion than controls (1.12 vs. 1.56, p = .015). At week 3, when compared to pre-op, Incrediwear subjects experienced a 19% decrease in effusion while controls experienced a 35% increase in effusion (p = .003). Preoperatively, there were no differences observed between Incrediwear subjects and controls flexion ROM (mean ROM 117 vs. 116, p = .67); however, by week 3, Incrediwear subjects had greater flexion ROM than controls (113 vs. 108, p = .02). Incrediwear subjects experienced only a 3% decrease in flexion ROM while controls experienced a 7% decrease in ROM (p = .07). Incrediwear subjects reported higher preoperative pain than controls (mean pain 4.2 vs. 3.2, p = .051); however, by week 3, there was no difference observed between these groups (2.9 vs. 3.0, p = .440). DiscussionNon-compressive sleeves embedded with semiconductor elements (Incrediwear) appeared to reduce effusion and improve knee flexion better than traditional compression stockings 3 weeks after total knee arthroplasty.

New concept of orthosis treatment for knee osteoarthritis: Clinical and radiological outcomes.

Given the increasing numbers of young patients with knee osteoarthritis there is a need for treatments that can postpone a joint prosthesis (total knee replacement). As an alternative to the effective yet invasive knee joint distraction procedure, a knee orthosis was developed aiming to unload the affected knee and improving synovial fluid flow. The aim of this study was to examine the effectiveness of using a load-reducing orthosis for two months on functioning, pain, and disease progression (e.g. amount of damaged cartilage) in patients with symptomatic osteoarthritis of the knee for at least one year. This is an interventional single-center pilot study. Ten patients with symptomatic osteoarthritis of one knee (5males/5 females; median age 57; age range 42-59) used a custom-made orthosis for 60 days during daily life activities that involved knee loading (e.g. standing, walking, but not during stair climbing). Cycling was not allowed. Clinical outcomes were assessed up to 24 months after intervention at 6 timepoints using patient reported-outcome measures Western Ontario and McMaster Universities Osteoarthritis (WOMAC) range 0-100; Visual Analogue Scale (VAS), range 0-100 for pain. Minimum joint space width (mJSW) was assessed using knee images digital analysis (KIDA) and articular cartilage volume with magnetic resonance imaging (MRI) using custom software at baseline and at 12 and 24 months follow-up. Clinically beneficial effects were found for functioning (WOMAC improvement compared to baseline ranged between 18 points at 3 months follow-up and 31 points at 12 months follow-up, with only the 24-months follow-up (improvement of 27 points) not reaching statistical significance (p< 0.05)) and for pain (VAS improvement compared to baseline at follow-up time points ranged between 41-56 points; all p< 0.05). No improvements in mJSW- or MRI-derived parameters were found. This study demonstrates that use of a custom-made knee-unloading orthosis for 60 days can result in improved functional ability and decrease in pain in relatively young patients with knee osteoarthritis. No effect on disease progression could be evidenced.

Combined positron emission tomography and contrast enhanced CT (PET/CeCT) is a feasible single investigation in the staging of oesophagogastric cancers: single-centre pilot study experience during the COVID-19 pandemic.

Staging of oesophagogastric (OG) cancers usually involves endoscopy (OGD), and separate visits for contrast enhanced computed tomography (CeCT) and positron emission tomography (PET/CT). At the height of the COVID-19 pandemic, some of our patients underwent single-visit combined staging with PET/CeCT. We compare this novel pathway with standard separate imaging in time to completion of staging, to start of treatment, and cost. We identified all patients discussed at our OG multidisciplinary team (MDT) meeting in 2020. Clinical records revealed dates of investigations and treatments. Data were tabulated in Excel, with statistical analysis in SPSS. All patients followed the same MDT process and image reviewing criteria. Costs were compared using prices supplied by finance departments. A total of 211 new patients were discussed at our MDT in 2020. Of these, 48 patients had combined PET/CeCT staging, and 68 had separate scans. Median time (interquartile range) in days from OGD to final imaging was 9 (6-23) for the combined group versus 21 (16-28) for the separate group (p≤0.001). Median time (days) from OGD to treatment start was 37 (29-52) for combined versus 55 (40-71) for separate (p≤0.001). No combined scans were of insufficient diagnostic quality for the MDT. PET/CeCT had a potential cost saving of £113 per patient. PET/CeCT allows accurate radiological staging of OG cancers with a single scan. Patients completed staging and started treatment faster, with a potential saving of £10,509 in one year. PET/CeCT has become standard staging at our trust, and we aim to incorporate radiotherapy planning images too.

Expression of Soluble Form of Aurora A as a Predictive Factor for Neoadjuvant Therapy in Breast Cancer Patients: A Single-Center Pilot Study.

To search for new predictive breast cancer biomarkers. We analyzed the serum concentrations of biomarkers involved in carcinogenesis, which can also be targeted by therapy. In a single-center prospective study, the serum levels of Aurora A, thymidine kinase 1, and human epidermal growth factor receptor type 3 (HER3) were determined in 119 women with BC before neoadjuvant treatment using ELISA kits. The following clinical data were analyzed: age; TNM; the expression of ER, PGR, HER2, and Ki67; histological grade (G); and the response to neoadjuvant treatment (NAT) in the residual tumor burden classification (RCB). A complete pathological response (pCR) was achieved after NAT in 41 patients (34%). The highest proportion of the patients with a confirmed pCR was found for triple negative breast cancer (TNBC) (62.5%); non-luminal HER2-positive (52.6%) cancer subtypes (p = 0.0003); and in the G3 group (50%; p = 0.0078). The patients with higher levels of Aurora A were more likely to achieve pCR (p = 0.039). In the multivariate analysis, the serum Aurora A levels ≥ 4.75 ng/mL correlated with a higher rate of pCR (OR: 3.5; 95% CI: 1.2-10.1; p = 0.023). We showed that in a biologically heterogeneous group of BC patients, the pretreatment serum Aurora A levels were of significant value in predicting the response to NAT.

Digital follow-up program for patients undergoing atrial fibrillation ablation: a pilot single-center study

Abstract Introduction Atrial fibrillation (AF) carries significant burden in health expenditure worldwide. Digital health technology may improve healthcare delivery, but its applicability in clinical practice and related outcomes remain a gap in evidence. Aim To report the implementation of a digital follow-up program (FUP) for patients submitted to AF ablation in an European center. Methods A digital FUP was implemented at a high-volume ablation center in 2020. The program featured a web platform for professionals, to record Clinician Reported Outcome Measurements (CROMs), during remote medical visits, and access Patient Reported Outcomes Measurements (PROMs). The program also included a mobile app for patients to report symptoms, vital signs, anthropometric and electrocardiographic data. Patients were invited to complete questionnaires at prespecified timepoints: Atrial Fibrillation Effect on qualiTy-of-life [AFEQT]; the Epworth and STOP-BANG for obstructive sleep apnea; nutritional questionnaire. Completeness rate was defined by the ratio of queries completed/queries sent at each timepoint. The mHealth App Usability Questionnaire (MAUQ) questionnaire was sent to patients and doctors; patients also received a Patient Reported Experience Measure (PREMs) 15 days after the ablation, from which a Net Promotor Score (NPS, -100 to 100) was calculated to express user’s satisfaction. This retrospective analysis includes data collected from December 2020 to September 2022. Results From the 305 ablations performed in this period, 253 patients were enrolled in the digital FUP: age 60±11 years, 67% male, 78% paroxysmal AF, body mass index 27.4±4.2 kg/m2. During a mean follow-up time of 11.9±5.8 months, 1120 CROMs were registered; 1449 PROMs were collected, including 5865 metrics reported by 90 different patients. App usage, measured by unique logins/month, was recorded in 54% of patients, of whom 13% submitted symptom checks weekly. 160 PREMs were registered; NPS scores for ablation and the app were 85.5 and 31.5, respectively [image]. Questionnaire overall completeness rate was: 54.5% for AFEQT; 14.4% for Epworth; 20.8% for STOP-BANG, that identified 55% of patients at high risk for sleep apnea. Nutritional assessment was completed by 18.7%; obese/pre-obese status was found in 21% and 48%, respectively; 18 patients were enrolled in a nutritional program. All doctors "agreed"/"strongly agreed" to overall satisfaction with the app. Conclusions The digital FUP was feasible and aided comorbidities assessment. Strategies to improve patient’s engagement and digital literacy are warranted. Further studies are needed to evaluate the platform’s impact on clinical outcomes.

32P Efficacy of olanzapine in the prophylaxis of delayed chemotherapy-induced nausea and vomiting in breast cancer patients receiving dose-dense AC with a steroid-sparing regimen: A single-center pilot study

32P Efficacy of olanzapine in the prophylaxis of delayed chemotherapy-induced nausea and vomiting in breast cancer patients receiving dose-dense AC with a steroid-sparing regimen: A single-center pilot study

Utility of Ocular β-D-Glucan Testing in Patients with Fungal Endophthalmitis.

To assess the diagnostic utility of (1→3)-β-D-glucan (BDG) in ocular fluid of patients with fungal endophthalmitis. This prospective pilot single-center study evaluated aqueous and vitreous humor BDG levels of suspected fungal endophthalmitis, bacterial endophthalmitis, and noninfectious controls with the standard Fungitell assay and the Fungitell STAT assay. BDG levels were compared using generalized linear models followed by post-hoc pairwise comparisons. Seven fungal endophthalmitis, six bacterial endophthalmitis, and 17 non-infectious ocular samples were evaluated. Mean aqueous BDG concentrations were 204, 11.0, and 9.6 pg/ml for fungal endophthalmitis, bacterial endophthalmitis and non-infectious controls, respectively (p=0.01, fungal vs. bacterial; p=0.0005, fungal vs. non-infectious controls). Mean vitreous BDG concentrations were 165, 30.3, and 5.4 pg/ml, respectively (p=0.001 for fungal vs. bacterial; p<0.0001 for fungal vs. non-infectious controls). Mean vitreous BDG index (Fungitell STAT) values were 1.7, 0.4, and 0.3, respectively (p=0.001, fungal vs. bacterial; p=0.0004, fungal vs. non-infectious controls). The Pearson correlation between BDG levels and BDG index was high (correlation coefficient=0.99, p<0.001). Significantly elevated ocular BDG levels were found in fungal endophthalmitis compared to bacterial endophthalmitis and non-infectious controls. Our study suggests a potential utility for BDG testing in the diagnosis of fungal endophthalmitis, and a larger study is warranted.

Effectiveness of Lactoferrin in the Treatment of Anemia in Chronic Kidney Disease: A Single-Center Pilot Study.

Anemia occurs in majority of patients with chronic kidney disease despite adequate dialysis and iron replete status. This study was done to evaluate the effects of lactoferrin with or without iron supplementation for the treatment of anemia in patients with chronic kidney disease (CKD). In this prospective, observational, single-center, single-arm pilot study, adult patients aged >18 years, having stage 5 CKD (estimated glomerular filtration rate [eGFR] <15 ml/min/1.73 m2), and who had anemia (hemoglobin [Hb] <10 g/dl; transferrin saturation [Tsat] >20%) were included. Patients were treated with 100 mg of oral lactoferrin twice a day for one month with or without iron supplementation. Patients had been on stable erythropoietin doses for ≥1 month prior to inclusion in the study. We report on the improvement in Hb levels and effect on inflammatory markers from baseline at four weeks. A total of 46 CKD patients having anemia were included. Patients had a mean age of 39.3 years, and a majority were men (69.6%). Improvement in the mean (SD) Hb level (g/dl) was observed from baseline (8.18 [1.19]) to Week 2 (8.54 [1.57]), which attained significance at Week 4 (8.96 [1.93]; P < 0.001; mean difference: -0.76; 95% confidence interval [CI]: -1.291 to - 0.2383). The improvement in Hb was higher in women than in men (P = 0.48) and in patients receiving lactoferrin with iron supplementation than in those receiving lactoferrin alone (P = 0.14). There was a non-significant decrease in the erythrocyte sedimentation rate (P = 0.14) and a non-significant increase in C-reactive protein (P = 0.54) level. Oral lactoferrin therapy was effective in improving hemoglobin levels in patients with advanced CKD and anemia. The effects of lactoferrin therapy on inflammatory markers remain uncertain.

THU078 The Definition And Epidemiology Of Giant Pituitary GH-Secreting Adenomas Based On Clinical, Imaging, And Hormonal Parameters: A Pilot Study

Abstract Disclosure: L.M. Del Corso: None. M.C. Silva: None. S.Z. Fidalski: None. C.L. Boguszewski: None. Acromegaly is a chronic disease, caused by a GH-secreting pituitary adenoma in most cases. At diagnosis, around 75% of patients have a macroadenoma, which constitute a heterogeneous group with variable biological behavior, therapeutic response, and prognosis. Giant adenomas (GA) have been defined as those which are more than 40 mm at their largest in diameter, but this is an arbitrary definition lacking comparative studies to investigate tumor size at diagnosis with clinical presentation, response to treatment and the evolution of acromegaly patients. Thus, the aim of our study was to compare the aforementioned variables according to the tumor size at diagnosis and review the diagnostic criteria for giant GH-secreting adenomas. In this observational, retrospective, single-centre pilot study, we have retrieved data from 161 medical records and evaluated age, sex, duration of symptoms, GH levels, presence of type 2 diabetes mellitus (T2DM), hypertension and hypopituitarism, imaging characteristics, and the need for adjuvant therapy with somatostatin receptor ligands (SRL) or other drugs. Study population was classified into four groups according to tumor size at diagnosis: (I) &amp;lt;10 mm (microadenomas; n=14); (II) 10-29 mm (n=84); (III) 30-39 mm (n=10); (IV) 40 mm or more (n=9). The final study group consisted of 117 individuals (49% men; mean age 43 ± 13 yrs). Hypopituitarism was significantly more frequent in groups III and IV compared to groups I and II (p=0.004), with no difference between groups III and IV (p=0,3). There was a higher proportion of invasive adenomas when the lesions ≥ 30 mm were compared to groups I and II (p=0.008), but with no difference between groups III and IV (p=0.62). Sixty percent of patients in group III (n=6) and 44% of patients in group IV (n=4) needed other drug therapy than SRL (cabergoline and/or pegvisomant), a higher proportion compared to those of groups I (n=1; 7%) and II (n=25; 30%) (p=0.04), again without difference between groups III and IV (p=0,7). Regarding the initial levels of GH, a significant difference was observed between groups I and IV (p=0.04), but this difference was not observed in the other groups. There were no statistical differences in relation to sex, duration of symptoms, need for SRL therapy, prevalence of hypertension and T2DM between study groups. Our study raises the hypothesis that giant adenomas should be defined as tumors larger than 30 mm, as the clinical behavior of tumors above this cutoff point seems to be similar in comparison with tumors larger than 40 mm but different from those of smaller sizes. Presentation: Thursday, June 15, 2023

202 Feasibility of Transesophageal Echocardiography in Out-of-Hospital Cardiac Arrest: A Single Center Pilot Study

202 Feasibility of Transesophageal Echocardiography in Out-of-Hospital Cardiac Arrest: A Single Center Pilot Study

Cardiac thrombus dissolution in acute ischemic stroke: A substudy of Mind the Heart

BackgroundCardiac thrombi are an important cause of ischemic stroke but are infrequently detected on cardiac imaging. We hypothesized that this might be explained by early dissolution of these cardiac thrombi after stroke occurrence. MethodsWe performed a single-center observational pilot study between November 2019 and November 2020, embedded in the larger “Mind-the-Heart” study. We included patients with AIS and a cardiac thrombus in the left atrium or ventricle (filling defect <100 Hounsfield Units) diagnosed on cardiac CT that was acquired during the initial stroke imaging protocol. We repeated cardiac CT within one week to determine if the thrombus had dissolved. ResultsFive patients (four men, median age 52 years, three with atrial fibrillation and one with anticoagulation therapy at baseline) were included. Median time from symptom onset to first cardiac CT was 383 (range 42–852) minutes and median time from first to second cardiac CT was three days (range 1–7). Two patients received intravenous thrombolysis (IVT). In total, six thrombi were seen on initial CT imaging (one in the left ventricle, four in the left atrial appendage, one in the left atrium). The left atrium thrombus and one left atrial appendage thrombus had dissolved on follow-up cardiac CT, one of which was in a patient with IVT treatment. ConclusionThis pilot study illustrates that cardiac thrombi can dissolve within days of stroke occurrence both with and without IVT treatment.