Blinded Pilot Study Research Articles

MP37-01 PILOT TRIAL FOR PIVoT: PREVENTION OF RECURRENT URINARY TRACT INFECTION USING VAGINAL TESTOSTERONE

You have accessJournal of UrologyCME1 May 2022MP37-01 PILOT TRIAL FOR PIVoT: PREVENTION OF RECURRENT URINARY TRACT INFECTION USING VAGINAL TESTOSTERONE Mariela Martinez, Arshia Sandozi, Jeffrey Lee, Liliya Vafina, Cassandra Pond, Robert Adelson, Elie Kaplan-Marans, Katiana Vazquez-Rivera, Annette Lee, and Allison Polland Mariela MartinezMariela Martinez More articles by this author , Arshia SandoziArshia Sandozi More articles by this author , Jeffrey LeeJeffrey Lee More articles by this author , Liliya VafinaLiliya Vafina More articles by this author , Cassandra PondCassandra Pond More articles by this author , Robert AdelsonRobert Adelson More articles by this author , Elie Kaplan-MaransElie Kaplan-Marans More articles by this author , Katiana Vazquez-RiveraKatiana Vazquez-Rivera More articles by this author , Annette LeeAnnette Lee More articles by this author , and Allison PollandAllison Polland More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002591.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Recurrent urinary tract infections (rUTI) in postmenopausal women have been associated with changes in vaginal flora. Vaginal estrogen treats atrophy thereby restoring flora, which prevents UTIs. While estrogen is effective, some patients have contraindications or are unwilling to use it. Vaginal testosterone cream (VT) has been shown to improve atrophy, however, its effects on flora and rUTIs are unknown. The purpose of this study was to determine the effect of VT versus placebo on vaginal flora in postmenopausal women with rUTI. METHODS: This randomized, double- blind pilot study enrolled postmenopausal women with rUTIs. Patients were randomized to VT or placebo. Vaginal health index (VHI) and vaginal swab to assess flora via DNA sequencing were collected at baseline and at one month follow up. RESULTS: A total of 21 patients were enrolled. Average VHI at enrollment was 16.68±4. There was no difference between groups at baseline with regard to VHI. There was diversity of vaginal flora in both treatment arms at baseline (Figure 1). Among patients who completed follow up, almost half of those in the VT arm had an increase in relative abundance of lactobacilli, which was not seen in the placebo patients. As compared to the placebo arm, a greater number of patients in the VT arm had a decrease in relative abundance of uropathogens such as Bacteroides and Pseudomonas. The majority of patients in the VT arm had improvement in VHI, which was not seen with placebo at one month. Four patients developed UTIs during the study, two in each arm. CONCLUSIONS: Initial data demonstrates increased abundance of lactobacilli and improvement in VHI at one-month post treatment with VT. Although there was no difference in the number of patients who developed UTIs between groups, longer treatment follow up and increased patient enrollment will be valuable in determining if VT is effective for UTI prevention. Source of Funding: AUA Urology Care Foundation Residency Research Award © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e607 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mariela Martinez More articles by this author Arshia Sandozi More articles by this author Jeffrey Lee More articles by this author Liliya Vafina More articles by this author Cassandra Pond More articles by this author Robert Adelson More articles by this author Elie Kaplan-Marans More articles by this author Katiana Vazquez-Rivera More articles by this author Annette Lee More articles by this author Allison Polland More articles by this author Expand All Advertisement PDF DownloadLoading ...

Can the neutrophil count from hepatic fine‐needle aspirate cytology be used to diagnose hepatitis in dogs? A pilot study

The cytologic diagnosis of inflammation on canine hepatic aspirates can be confounded by neutrophilic infiltrates in the liver of dogs with nodular regeneration, by extramedullary hematopoiesis, and by marked blood contamination. We aimed to assess the association between neutrophil counts on hepatic cytology and the histopathologic diagnosis in dogs with hepatitis and non-inflammatory hepatopathy. We also sought to determine a cut-off value for the cytologic diagnosis of hepatitis. In a retrospective blinded pilot study, three observers independently reviewed hepatic aspirates that had corresponding histopathologic examinations performed within 2days. The number of neutrophils per 200 hepatocytes was determined and averaged among observers. Only neutrophils within or directly in contact with a cluster of ≥5 hepatocytes were counted, and only intact hepatocytes within an approximate monolayer were included. Data are presented as the median (range), and the Mann-Whitney U test is used to make comparisons between groups. Eighteen cases were included (13 hepatitis and five vacuolar hepatopathy). Aspirates with a histopathologic diagnosis of hepatitis had increased numbers of neutrophils compared with those of vacuolar hepatopathy (7.7 [0.3-18.3] vs 3.0 [1.0-5.3]; P=.038). Receiver operating characteristic curve analysis indicated that ≥6 neutrophils were 61.5% (CI 31.6%-86.1%) sensitive and 100% (CI 47.8%-100%) specific for identifying hepatitis. Liver aspirates from hepatitis cases have a higher number of neutrophils on cytology compared with those from vacuolar hepatopathy; however, larger studies, including those with dogs with other liver pathologies, are required. Identification of six or more neutrophils per 200 hepatocytes is highly suggestive of hepatitis.

The effect of standardized honey on mucosal healing of the nose and paranasal sinuses after polypectomy: A randomized controlled, double blind pilot study.

Objectives:Nasal polyposis (NP) is a chronic inflammatory disease. Honey has several anti-microbial, anti-oxidants, healing, and anti-inflammatory properties which may reduce the need for steroids in this situation. Therefore, the aim of this study is to show the effect of standardized honey on mucosal healing of the nose and paranasal sinuses after polypectomy.Design and method:In this double-blind, randomized, placebo-controlled clinical trial, 28 patients with nasal polyposis underwent functional endoscopic sinus surgery (FESS). Besides common post-op medications, normal saline (as placebo) and diluted processed honey were used separately in the two nostrils of each patient. Two endoscopic follow-ups using the Philppot-Javer (P-J) scoring system were performed to assess the healing and recurrence of polyps on either side. The secondary outcome measure was the patients’ satisfaction rate.Results:The patients’ mean age was 38.03±11.9 years. 15(57.7%) had a positive prick test and also 15(57.7%) had dense eosinophilic infiltration in their surgical specimens. In the first and second follow-up sessions, total P-J scores showed better results for honey in comparison to the normal saline side but that results were not significantly different (P=0.93, P=0.07); whereas it is fair to say that in the second follow-up, the ethmoid and maxillary sinuses demonstrated a greater difference compared to the other sites based on their averages but there were not significantly meaningful (P=0.05, P=0.06). The total score also showed better results for honey in comparison to the normal saline side, but statistically insignificant (P=0.07).Conclusion:Diluted honey seems to have certain positive effects in reducing post-operative edema and the recurrence of nasal polyps in at least the ethmoid and maxillary sinuses; although this positive effect did not result in significant changes. (www.actabiomedica.it)

Effectiveness of platelet rich fibrin versus demineralized bone xenograft in periodontally accelerated osteogenic orthodontics.

To compare the rate of extraction space closure between periodontally accelerated osteogenic orthodontics (PAOO) using platelet-rich fibrin (PRF) (Group 1) and PAOO using demineralized bone xenograft (DMBM) (Group 2) and to compare the level of wound healing between the PRF group vs the DMBM group after PAOO. A two-arm prospective single blind pilot study with a split-mouth design was used in which 14 patients requiring premolar extraction were divided into two groups: PRF and DMBM. En-masse space closure was carried out with using mini implants after the PAOO procedure. The amount of space closure was measured at five time points with 2-week intervals within 2 months. The gingival healing levels were assessed using early wound healing scores on the first postoperative day. The rate of extraction space closure was faster in the experimental quadrant at all time points (T1-T4) in the PRF group and at time points (T3, T4) in the DMBM group. Comparison between experimental quadrants showed a significant increase in the rate of space closure in the PRF group T1 to T3 (P < .05). The PRF group showed higher total early healing scores than the DMBM group. PRF, when used in the PAOO procedure, produces a faster rate of space closure with better early wound healing than DMBM.

Clinical Evaluation of Unani formulation in Gastritis- A Pilot Study

Background and objectives: Gastritis is a painful or inflammatory state of the stomach and the mucosa covering it. The most common cause of gastritis is helicobacter pylorus. It is caused by certain infection, or by the routine use of antiinflammatory painkiller. Unani Physician has identified various medicinal products in classical text indicated for the treatment of gastritis. Therefore, a clinical trial was conducted to evaluate the clinical efficacy and safety of Unani Formulation in gastritis on scientific parameters. Methods: The study was designed as single blind pilot study on 12 patients of gastritis. Unani Formulation (Amla-2 part, Asl-Us-Soos-2 part, and Badiyan-2part) was given in the form of powder at the dose of 6 g twice a day after meal for the period of 28 days. All the patients of were assessed weekly on subjective parameters (at 0, 7th, 14th , 21th, and 28th day) whereas objective parameters were assessed before and after the treatment. The outcome of intervention was analyzed using appropriate statistical methods. Results: The study effects on subjective parameters like pain in abdomen, epigastric burning, nausea &amp; vomiting and early satiety were found significantly reduced significantly. The objective parameter VAS and 5 PLS was found highly significant when compared before and after with p&lt;0.0001. The results were analyzed after using paired ‘t’ test. Interpretation &amp; Conclusion: The findings about the both parameters (subjective and objective) that the ‘Unani Formulation is effective gastritis and the cure was significant. Safety parameters (SGOT, SGPT, Blood Urea and Serum Creatinine) were remains unchanged. Therefore, it can be concluded that the Unani Formulation is safe and effective in management of gastritis.

Effectiveness of a combination therapy using non-ablative fractional laser and intralesional triamcinolone injection for thyroidectomy scar treatment: a prospective, randomized, blinded pilot study.

The occurrence of thyroid cancer has increased dramatically, and postoperative scars are placed at easily visible locations. Many patients show stronger desire for scar prevention. So far, numerous approaches have been discussed for the treatment of scars; this study is conducted to verify whether the early application of combined therapy contributes to minimal scar formation. Between March 2019 and December 2019, total of 64 patients with thyroidectomy scars of a size greater than 4.5cm located on the anterior neck were enrolled in this prospective pilot study. Subjective and objective evaluation were carried out using the Patient and Observer Scar Assessment Scale (POSAS) at one, two, and six months after operation. Results were compared between a treatment group and a non-treatment group. In PSAS score, the mean values of pain, itching sensation, pliability, thickness, and relief were significantly higher in the laser and steroid treatment group (p=0.009, p=0.000, p=0.013, p=0.002, and p=0.007). The value of color of the scars showed no significant differences (p=0.504). In OSAS score, parameter of thickness, relief, and surface area score was significantly higher score in the combination group (p=0.029, 0.035, and 0.020), while vascularity, pigmentation, and pliability were not significantly different between two groups (p=0.548, p=0.983, and p=0.128). This study demonstrates that early combination therapy contributes to scar improvement to a meaningful extent based on POSAS. We believe that the combined therapy has a synergy effect on scar management, which improves the patients' quality of life in relation to their postoperative scars.

A microfluidic sperm-sorting device reduces the proportion of sperm with double-stranded DNA fragmentation.

Sperm DNA fragmentation can be produced in one (ssSDF) or both (dsSDF) DNA strands, linked to difficulties in naturally achieving a pregnancy and recurrent miscarriages, respectively. The techniques more frequently used to select sperm require centrifugation, which may induce sperm DNA fragmentation (SDF). The objective of this study was to assess whether the microfluidic-based device FertileChip® (now ZyMot®ICSI) can diminish the proportion of sperm with dsSDF. First, in a blinded split pilot study, the semen of nine patients diagnosed with ≥60% dsSDF, was divided into three aliquots: not processed, processed with FertileChip®, and processed with swim up. The three aliquots were all analyzed using neutral COMET for the detection of dsSDF, resulting in a reduction of 46% (P < 0.001) with FertileChip® (dsSDF: 34.9%) compared with the ejaculate and the swim up (dsSDF: 65%). Thereafter, the FertileChip® was introduced into clinical practice and a cohort of 163 consecutive ICSI cycles of patients diagnosed with ≥60% dsSDF was analyzed. Fertilization rate was 75.41%. Pregnancy rates after the first embryo transfer were 53.2% (biochemical), 37.8% (clinical), 34% (ongoing) and the live birth rate was 28.8%. Cumulative pregnancy rates after one (65.4% of patients), two (27.6% of patients) or three (6.4% of patients) transfers were 66% (biochemical), 56.4% (clinical), 53.4% (ongoing) and the live birth rate was 42%. The selection of spermatozoa using Fertile Chip® significantly diminishes the percentage of dsSDF, compared with either the fresh ejaculate or after swim up. Its applicability in ICSI cycles of patients with high dsSDF resulted in good laboratory and clinical outcomes.

Orthopaedic Surgeon Physiological Indicators of Strain as Measured by a Wearable Fitness Device.

Symptoms of stress, depression, and burnout are prevalent in medicine, adversely affecting physician performance. We investigated real-time measurements of physiological strain in orthopaedic resident and faculty surgeon volunteers and identified potential daily stressors. We performed a prospective blinded cohort pilot study in our academic orthopaedic department. Physicians used a wearable fitness device for 12 weeks to objectively measure heart rate variability (HRV), a documented parameter of overall well-being. Baseline burnout levels were assessed using the Maslach Burnout Inventory questionnaire. Daily surveys inquiring on work responsibilities (clinic, operating room [OR], or "other") were correlated with physiological parameters of strain. Descriptive statistics and linear mixed effects modeling were used to evaluate bivariate relationships. Of the 21 participating surgeons, 9 faculty and 12 residents, there was a response rate of 95.2% for the initial burnout survey. Daily surveys were completed for 63.8% (54.9 ± 22.3 days) of the total collection window, and surgeons wore the device for 83.2% of the study (71.6 ± 25.0 days). Residents trended toward lower personal accomplishment and greater psychological detachment on the Maslach Burnout Inventory, with 5 surgeons including 1 faculty surgeon (11.1%) and 4 resident surgeons (33.3%) found to have negatively trending HRV throughout the study period demonstrating higher physiological strain. Time in the OR led to increased next-day HRV (y-intercept = 47.39; B = 4.90; 95% confidence interval, 2.14-7.66; P < 0.001), indicative of lower physiological strain. An increase in device-reported sleep from a surgeon's baseline resulted in a significant increase in next-day HRV (y-intercept = 50.46; B = 0.64; 95% confidence interval, 0.11-1.17; P = 0.02). Orthopaedic residents, more than faculty, had physiologic findings suggestive of burnout. Time in the OR and increased sleep improved physiological strain parameters. Real-time biometric measurements can identify those at risk of burnout and in need of well-being interventions. Level III.

Adherence to oral antibiotic therapy in patients with bone and joint infection: A pilot study

ObjectivesThe management of bone and joint infections (BJI) is complex and requires prolonged antimicrobial therapy. Few data exist on adherence to anti-infectious treatment other than HIV, and none on BJI, even though compliance is considered as a major determinant of clinical outcome. This work aimed at evaluating adherence to oral antimicrobial treatment in patients with BJI. Patients and methodsThis is a prospective observational blinded pilot study evaluating adherence by a 6-item questionnaire at 6 weeks (W6) and 3 months (M3) post-surgery. The primary endpoint was the proportion of patients with high, moderate and poor adherence at W6. Secondary endpoints included change in adherence between W6 and M3, and the exploration of potential variables influencing adherence. ResultsAnalysis was performed on 65 questionnaires obtained from 43 patients including 35 with device-associated BJI. At W6, 11 out of 34 patients were highly adherent to oral antibiotic therapy, 22 moderately adherent and 1 poorly adherent. There was no significant change in adherence to antibiotic therapy between W6 and M3. The only variable significantly associated with the level of adherence at W6 and M3 was the number of daily doses of antibiotic (P=0.04 and 0.02 at W6 and M3, respectively). ConclusionsThis study provided a snapshot of patients’ adherence in BJI. Adherence to antibiotic therapy appeared to be stable up to 3 months and a higher number of daily doses of antibiotic was associated with poorer adherence. These observations need to be confirmed in future large-scale studies using electronic pill monitoring systems.

Multicomponent exercise training in cardiovascular complexity in prefrail older adults: a randomized blinded clinical pilot study.

The aim of this study was to investigate the effects of multicomponent training on baroreflex sensitivity (BRS) and heart rate (HR) complexity of prefrail older adults. Twenty-one prefrail community-dwelling older adults were randomized and divided into multicomponent training intervention group (MulTI) and control group (CG). MulTI performed multicomponent exercise training over 16 weeks and CG was oriented to follow their own daily activities. The RR interval (RRi) and blood pressure (BP) series were recorded for 15 min in supine and 15 min in orthostatic positions, and calculation of BRS (phase, coherence, and gain) and HR complexity (sample entropy) were performed. A linear mixed model was applied for group, assessments, and their interaction effects in supine position. The same test was used to assess the active postural maneuver and it was applied separately to each group considering assessments (baseline and post-intervention) and positions (supine and orthostatic). The significance level established was 5%. Cardiovascular control was impaired in prefrail older adults in supine position. Significant interactions were not observed between groups or assessments in terms of cardiovascular parameters. A 16-week multicomponent exercise training did not improve HR complexity or BRS in supine rest or in active postural maneuver in prefrail older adults.

ROLE OF UDUMBARADI TAILA YONIPICHU IN THE MANAGEMENT OF KAPHAJA YONIYVAPAD - A PILOT STUDY

Background: Vaginal discharge, commonly known as leucorrhea, is a physiological condition which happens in female reproductive system. More than 75% women experience leucorrhea during their lifetime and 45% of them has recurrence. Objectives: To assess the efficacy of Udumbaradi Taila Yoni Pichu in management of Kaphaja Yoni Vyapad. Design: This is a single blind pilot study. 20 female patients with the complaints of Kaphaja Yonivyapad (nonspecific leucorrhoea) from the Dept. of Prasooti tantra and Stree Roga OPD of Rajiv Gandhi educational society’s Ayurvedic Medical College, Ron were included for the study. Patients were administered Udumbaradi Taila Yonipichu for 7 days and were assessed before and after the treatment and followed up on the 14th day. Results: This pilot study showed statistically significant changes with Udumbaradi Taila Yonipichu in reducing the complaints of Kaphaja Yoni Vyapad such as Katishoola (p&lt;0.001), Kandu (p&lt;0.001), consistency of the Srava (p&lt;0.001) and Srava Pramana (quantity of the discharge) (p&lt;0.001). Conclusions: Udumbaradi Taila Yonipichu showed effectiveness in the management of Kaphaja yoni Vyapad with the reduction of Katishoola, Kandu, consistency of the Srava and Srava pramana after the treatment.

Effect of transcutaneous cervical vagus nerve stimulation on the pituitary adenylate cyclase-activating polypeptide (PACAP) response to stress: A randomized, sham controlled, double blind pilot study

Pituitary adenylate cyclase-activating peptide (PACAP) is a neuropeptide that plays a key role in the neurobiology of the stress response, and prior studies suggest that its function is dysregulated in post-traumatic stress disorder (PTSD). Transcutaneous cervical vagus nerve stimulation (tcVNS) acts through PACAP and other neurobiological systems to modulate stress responses and/or symptoms of PTSD. In this pilot study, we examined the effects of tcVNS on PACAP in a three day chronic stress laboratory paradigm involving serial traumatic and mental stress exposures in healthy individuals with a history of exposure to psychological trauma (n ​= ​18) and patients with PTSD (n ​= ​12). MethodsA total of 30 subjects with a history of exposure to psychological trauma experience were recruited (12 with PTSD diagnosis) for a three-day randomized double-blinded study of tcVNS or sham stimulation. Subjects underwent a protocol that included both personalized trauma recall and non-personalized mental stressors (public speaking, mental arithmetic) paired to tcVNS or sham stimulation over three days. Blood was collected at baseline and multiple time points after exposure to stressors. Linear mixed-effects models were used to assess changes in PACAP over time (in response to stressors) and its relation to active tcVNS or sham stimulation. ResultsPACAP blood levels increased over the course of three days for both active tcVNS and sham groups. This increase was statistically-significant in the sham group at the end of the second (Cohen’s drm ​= ​0.35, p ​= ​0.04), and third days (drm ​= ​0.41, p ​= ​0.04), but not in the active tcVNS group (drm ​= ​0.21, drm ​= ​0.18, and p ​> ​0.20). ConclusionThese pilot findings suggest tcVNS may attenuate this neurobiological stress-response. Larger studies are needed to investigate gender and interaction effects.

Diagnostic accuracy of a novel third generation esophageal capsule as a non‐invasive detection method for Barrett's esophagus: A pilot study

Previous two generations of esophageal capsule did not show adequate detection rates for Barrett's esophagus (BE). We assessed the diagnostic accuracy of a novel third generation capsule with an improved frame rate of 35 frames per second for the detection of BE in a pilot study. This was a blinded prospective pilot study conducted at a tertiary medical center. Patients with known BE (at least C0M>1) who presented for endoscopic surveillance (May to October 2017) were included. All patients underwent novel esophageal capsule (PillCam™ UGI; Medtronic) ingestion using the simplified ingestion protocol followed by standard high-definition upper endoscopy (esophagogastroduodenoscopy [EGD]). Capsule endoscopy findings were interpreted by examiners blinded to endoscopy results and compared with endoscopic findings (gold standard). Following completion of both tests, a subjective questionnaire was provided to all patients regarding their experience. Twenty patients (95%males, mean age 66.3 [±7.9] years) with BE undergoing surveillance EGD were eligible. The mean BE length was 3.5 (±2.7) cm. Novel esophageal capsule detected BE in 75% patients when images were compared with endoscopy. Novel capsule detected BE in 82% patients when the BE length was ≥2cm. The mean esophageal transit time was 0.59s. On a subjective questionnaire, all 20 patients reported novel capsule as being more convenient compared with EGD. In this pilot, single-center study, novel esophageal capsule was shown to be not ready for population screening of BE. Studies integrating artificial intelligence into improved quality novel esophageal capsule should be performed for BE screening.

AYURVEDIC MANAGEMENT OF GARBHINI CHARDI (Emesis Gravidarum) WITH CHATURJATA CHOORNA (CHATURJATA POWDER) - A PILOT STUDY

Background: During pregnancy many demands are made by growing fetus, to meet these requirements maternal system has to undergo certain changes. Garbhinichardi (Emesis Gravidarum) is one among them and this has been termed as Gruhita Garbha Lakshanas (Immediate signs of conception) in Ayurvedic clas-sics. Approximately 80 % of pregnant women experience excessive salivation, nausea and vomiting during pregnancy, commonly known as “morning sickness”, which is seen frequently throughout the day. Design: This is single blind pilot study. 30 patients with complaints of Garbhinichardi (Emesis Gravidarum) in first trimester were included in this study. Patients were given Chaturjatachurna (Chatutjata powder)for a peri-od of 2 weeks in dose of 3gms thrice a day after meal with Anupana (Adjuvant) as Madhu (honey) of 5ml mixed with Tandulodaka (Raw rice water) Results: This pilot study showed statistically significant changes with Chaturjatachurna in reducing the complaints of pregnant women such as nausea (p&lt;0.001), vomiting (p&lt;0.001) and Aruchi (Anorexia) (p&lt;0.001) in their first trimester of pregnancy. Conclusion: Chaturjata-churna was effective in the management of Garbhini Chardi (Emesis Gravidarum) and other symptoms in the first trimester of pregnancy.

Abstract 6478: Circulating stromal cells in resectable pancreatic cancer is associated with high pathological stage and poor clinical outcomes

Abstract Background: Pancreatic cancer (PC) is a difficult malignancy to diagnosis and properly stage, with extremely poor outcomes even for patients (pts) with resectable disease. Cancer Associated Macrophage-Like cells (CAMLs) are a recently described circulating stromal cell common to the blood of cancer pts, whose presence and size (≥50µm) is a prognostic indicator of poor progression free survival (PFS) and overall survival (OS). However, the clinical value of CAMLs in PC has not been evaluated. We recruited treatment naïve PC pts referred for surgical resection before therapy induction to study CAML association to PFS/OS. We investigate whether a simple blood test can better identify pts with metastatic disease and act as a predictor for PFS and OS. Methods: 68 whole peripheral blood samples were drawn from untreated newly diagnosed PC pts referred for surgical resection prior to induction of therapy. Pts were recruited for a 2 year single blind prospective pilot study testing &amp;gt;5 CAMLs, CAML size (≥50µm), CA19-9, &amp; CEA to clinical stage (CS), pathological stage (PS), and resectability. Pts were referred based on CS with resectable (R) (n=23), borderline resectable (BR) (n=27), or locally advanced (LA)/metastatic (M) (n=16); Stage I (n=50), Stage II (n=12), Stage III (n=0), Stage IV (n=3), and unknown stage (n=2). Blood samples (7.5mL) were taken prior to any neoadjuvant therapy. Blood was filtered by CellSieveTM filtration and CAMLs quantified. Analysis of CAMLs, protein markers, and resectability were used to evaluate PFS and OS significance by log-rank testing. Results: CAMLs were found in 92% (n=61/66) of pt samples and averaged 7.5 CAMLs/7.5 mL blood. In pts that received surgery, 22 pts were upstaged with PS; stage I (n=20), Stage II (n=16), Stage III (n=5), Stage IV (n=18), &amp; 7 pts withdrawing prior to surgery. All early stage pts with ≥12 CAMLs (n=6) were upstaged to metastatic disease after surgical resection. CEA and CA19-9 serum were not significant for PFS (CEA HR 0.9, p=0.639 and CA19-9 HR 0.6, p=0.288). Further, R vs BR was not significant for PFS (HR 0.4 p=0.10) nor was BR vs LA (PFS HR=0.2 p=0.075), though in both comparisons resectability did trend non-significantly toward better PFS. &amp;gt;5 CAMLs was not a significant indicator of PFS or OS (PFS HR 0.6 p=0.175 and OS HR 1.0 p=0.902). However, ≥50µm CAMLs was a highly significant indicator of both PFS and OS (PFS HR 4.0 CI95% 2.0-7.8, p&amp;gt;0.001 and OS HR 2.3 CI95% 1.1-4.7, p=0.035). Conclusions: In PC, accurate staging/resectability is difficult, with 60% of pts being upstaged post-surgery and ~80% recurring in 2 years. There is a need for a better method to stratify surgical candidates that won't benefit from surgical resection. These data suggest that high CAML numbers at diagnosis identifies pts with metastatic disease which are less likely to benefit from surgical resection, and enlarged CAML size correlates to poorer PFS and OS. Citation Format: Kirby P. Gardner, Daniel L. Adams, Mohammed Aldakkak, Cha-Mei Tang, Susan Tsai. Circulating stromal cells in resectable pancreatic cancer is associated with high pathological stage and poor clinical outcomes [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 6478.

Transcranial direct current stimulation and attention skills in burnout patients: a randomized blinded sham-controlled pilot study.

Background: Burnout is characterized by deficiencies in attention and several components of the working memory. It has been shown that cognitive behavioral therapy can have a positive effect on burnout and depressive symptoms, however, the lingering effects of impaired attention and executive functions are the most frustrating. We hypothesized that anodal transcranial direct current stimulation (atDCS) over the left dorsolateral prefrontal cortex (DLPFC) can improve the executive control of attention and possibly several other components of working memory in patients with burnout. Methods: This was a randomized double-blind sham-controlled pilot study with two groups. Patients with burnout received three weeks of daily sessions (15 sessions in total) of atDCS or sham stimulation in addition to three weekly sessions of standard behavioral therapy. The primary outcome measure was attention and the central executive of the working memory. Secondary, the effect of atDCS was measured on other components of working memory, on burnout and depression scores, and on quality of life (QoL). Results: We enrolled and randomly assigned 16 patients to a sham or real stimulation group, 15 (7 sham, 8 real) were included in the analysis. atDCS had a significant impact on attention. Post-hoc comparisons also revealed a trend towards more improvement after real tDCS for inhibition and shifting, updating and control, and encoding. Both groups improved on burnout and depression scores. Conclusion: These data provide preliminary evidence for the value of atDCS over the left DLPFC in rehabilitating attention deficits, and possibly also central executive and encoding deficits, in burnout. However, the current study has some limitations, including the sample size and heterogeneous patient population. More elaborate studies are needed to elucidate the specific impact of atDCS over the left DLPFC on burnout. Trial registration: ISRCTN.com ( ISRCTN94275121) 17/11/19.

The safety and feasibility of a Halliwick style of aquatic physiotherapy for falls and balance dysfunction in people with Parkinson's Disease: A single blind pilot trial.

BackgroundThere is growing evidence that aquatic physiotherapy may be effective for people with Parkinson’s Disease (PD) but most studies have investigated land based type exercises in the aquatic environment. Few studies have examined customised aquatic therapies such as the Halliwick concept which focuses on trunk rotation and core stabilisation.ObjectiveThe primary aim was to determine the feasibility of a Halliwick style aquatic physiotherapy intervention for people with PD. The secondary aim was to compare the Halliwick intervention with traditional aquatic and land based physiotherapy in terms of disease severity, balance and fear of falling.MethodsHalliwick style aquatic, traditional aquatic and land based physiotherapy were trialled in a single blind pilot study. All interventions ran for 60 minutes per week over 12 weeks. Feasibility outcomes were safety, adherence and attrition. Secondary outcomes included the Unified Parkinson’s Disease Rating Scale motor subsection (UPDRS-III), Berg Balance Scale (BBS), Mini BESTest and modified Falls Efficacy Scale (mFES).Results30 participants with moderate PD were recruited. Participant mean age was 72 years (SD 8.4; range 51–86) with moderate disease severity (median Hoehn & Yahr score 3; IQR 1).No falls occurred during intervention sessions, however ten participants reported falls during the study period. No other adverse consequences were reported. All groups had adherence over 85%. No within group significant differences were found in UPDRS-III, BBS or mFES scores post-intervention for all groups, but the Halliwick aquatic group improved significantly in the Mini BESTest post-intervention (p = 0.011, 95% CI -7.36,-1.31, t (10) = -2.98).ConclusionsDespite people with PD being a vulnerable population, aquatic physiotherapy, including the Halliwick style is a safe treatment option. Promising results for balance in the Halliwick aquatic group were observed, but further studies with larger sample sizes is required to increase confidence in the results.

Transcranial direct current stimulation and attention skills in burnout patients: a randomized blinded sham-controlled pilot study

Background: Burnout is characterized by deficiencies in attention and several components of the working memory. It has been shown that cognitive behavioral therapy can have a positive effect on burnout and depressive symptoms, however, the lingering effects of impaired attention and executive functions are the most frustrating. We hypothesized that anodal transcranial direct current stimulation (atDCS) over the left dorsolateral prefrontal cortex (DLPFC) can improve the executive control of attention and possibly several other components of working memory in patients with burnout. Methods: This was a randomized double-blind sham-controlled pilot study with two groups. Patients with burnout received three weeks of daily sessions (15 sessions in total) of atDCS or sham stimulation in addition to three weekly sessions of standard behavioral therapy. The primary outcome measure was attention and the central executive of the working memory. Secondary, the effect of atDCS was measured on other components of working memory, on burnout and depression scores, and on quality of life (QoL). Results: We enrolled and randomly assigned 16 patients to a sham or real stimulation group, 15 (7 sham, 8 real) were included in the analysis. atDCS had a significant impact on attention. Post-hoc comparisons also revealed a trend towards more improvement after real tDCS for inhibition and shifting, updating and control, and encoding. Both groups improved on burnout and depression scores. Conclusion: These data provide preliminary evidence for the value of atDCS over the left DLPFC in rehabilitating attention deficits, and possibly also central executive and encoding deficits, in burnout. However, the current study has some limitations, including the sample size and heterogeneous patient population. More elaborate studies are needed to elucidate the specific impact of atDCS over the left DLPFC on burnout. Trial registration: ISRCTN.com ( ISRCTN94275121) 17/11/19

Treatment interventions for Severe and Enduring Eating Disorders: Systematic review

Approximately 20% of people with Anorexia Nervosa (AN) and 10% with Bulimia Nervosa (BN) will eventually develop a long-standing illness. Although there is no set definition for Severe and Enduring eating Disorder (SE-ED), the common criteria relate to a long duration of the disorder and a number of unsuccessful treatment attempts. Research evidence for treatment of SE-ED remains limited, thus the objective of this systematic review was to describe different treatment interventions and their effects on SE-ED-related outcomes. A systematic search for quantitative treatment studies of adult participants with SE-ED was conducted in June 2019 (PROSPERO, CRD42018115802) with no restriction on eating disorder type. Altogether, 2,938 studies were included for title and abstract screening. After systematic searches and article screening, 23 studies (3 randomized controlled trials, 3 open-label studies, 8 naturalistic follow-up studies, 8 case series and case studies, and 1 partially blinded pilot study) were included in the analysis and data extraction. Methodological quality of the included studies was generally low. Inpatient treatment programs (n = 5) were effective in short-term symptom reduction, but long-term results were inconsistent. Outpatient and day-hospital treatment programs (n = 5) seemed promising for symptom reduction. Drug interventions (n = 5) showed some benefits, especially as adjuvant therapies. Brain stimulation (n = 6) led to improvements in depressive symptoms. Other treatments (n = 2) produced mixed results. This is the first systematic review to examine all of the different treatment interventions that have been studied in SE-ED. The results will inform future interventions in research and clinical practice.

The Effect of Surgical Video on Resident Performance of Carpal Tunnel Release: A Cadaveric Simulation-Based, Prospective, Randomized, Blinded Pilot Study.

Surgical videos are increasingly common, although their role in residency curricula remains unclear. The aim of this study was to evaluate the impact of an educational surgical video on resident performance of an open carpal tunnel release through an Objective Structured Assessment of Technical Skills and serial questionnaires. Twenty-two residents representing six postgraduate years were randomized to receive text-based materials with or without a surgical video before performing a carpal tunnel release on human cadavers. Procedures were video recorded, anonymized, and independently evaluated by three hand surgeons using the Objective Structured Assessment of Technical Skills global rating scale, a procedure-specific technical rating scale, a record of operative errors, and pass/fail designation. Residents completed questionnaires before and after the procedure to track confidence in their technical skills. Residents in their first and second postgraduate years (n = 10) who watched the surgical video committed fewer operative errors (median, 4 versus 1.3; p = 0.043) and were more confident in their abilities following the procedure (median, 75 versus 32; p = 0.043) than those receiving text resources alone. There were no significant differences in Objective Structured Assessment of Technical Skills performance or questionnaire responses among more senior residents (n = 12). The technical rating scale was internally consistent (Cronbach α = 0.95; 95 percent CI, 0.91 to 0.98), reliable (intraclass correlation coefficient, 0.73; 95 percent CI, 0.40 to 0.88), and correlated with surgical experience (Spearman ρ = 0.57; p = 0.006). Watching an educational surgical video to prepare for a cadaveric procedure significantly reduced operative errors and improved confidence among junior trainees performing a carpal tunnel release.