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Introduction: Therapy and immune mediated processes are associated with clonal evolution in multiple myeloma (MM). In this study, we performed whole-exome sequencing (WES) and single cell RNA sequencing (scRNA-seq) on plasma cells (PC) from bone marrow aspirates of the iliac crest (BM) and corresponding osteolytic lesions (OL) to investigate spatial heterogeneity in patients with newly diagnosed (NDMM) and relapsed/refractory MM (RRMM). Next generation flow (NGF) and T-cell receptor sequencing (TCRseq) were performed to investigate the immunogenomic landscape surrounding malignant PC. Methods: In a prospective trial, 18 patients (NDMM: n=10; RRMM: n=8) consented to an imaging-guided biopsy of an OL in addition to the regular BM sampling. At inclusion, 37 different locations were biopsied. Follow-up samples were obtained from 5 patients in remission after therapy. After CD138+ selection, PC were subjected to WES and scRNA-seq (Chromium, 10x genomics). TCRseq was performed using multiplex PCR (ImmunoSEQ, Adaptive biotechnologies) on the CD138- fraction. For scRNA-seq data analyses, Cell Ranger (v3.1.0) and the Seurat R toolkit (v3.1) were used. TCRseq data were analyzed with immunoSEQ ANALYZER (v3.0) and the immunarch R toolkit (v0.6.6.). NGF was performed to study subsets of T-, B-, NK- and dendritic cells (DC). Results: Median PC infiltration was higher in OL compared to random BM (50.0% vs 12.5%, p=0.041). WES revealed more mutations in RRMM compared to NDMM (median; range: 189;120-523 vs 71;23-136, p Conclusion: We report the first prospective clinical trial to investigate spatiotemporal immunogenomic heterogeneity in multiple myeloma as assessed by WES and scRNA-seq of PC and NGF and TCRseq of the non-PC compartment. We demonstrate spatial evolution and reduced TCR diversity especially in patients with RRMM and/or EMD. ScRNA-seq adds another layer of complexity compared to WES and helps identifying how PC create an immune suppressive BM niche. Disclosures Merz: Amgen, BMS, Celgene, Takeda: Honoraria. Block:GlaxoSmithKline LLC: Current Employment. McCarthy:Karyopharm: Consultancy, Honoraria; Magenta: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Advisory Board; Juno Therapeutics, a Bristol-Myers Squibb Company: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Advisory Board , Research Funding is to Roswell Park, Research Funding; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Advisory Board; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Advisory Board; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Advisory Board; Starton: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Advisory Board; Genentech: Consultancy, Honoraria. Hillengass:Adaptive, Amgen, BMS, Celgene, GSK, Janssen, Oncotracker, Takeda: Honoraria.

PURPOSE: Treatment-related adverse events associated with systemic anticancer therapy (SACT) can deter patients with sarcoma from completing treatment. With self-monitoring, patients may be better empowered to self-advocate for improved symptom management. We hypothesized that by incorporating journaling, a structured form of self-monitoring, care team communication, and symptom management would improve. We thus designed a prospective randomized trial exploring journaling as a therapeutic adjuvant for symptom management ( NCT03258892 ). METHODS: Participants with sarcoma initiating SACT were randomly assigned to receive either a symptom management journal at the start of SACT or after completing two cycles of SACT. Symptom journals were designed jointly by a cancer patient focus group and by education experts. Journals were reviewed with clinical staff at each visit. Participant responses were obtained through questionnaires. Patient call volume was obtained through the electronic health record. RESULTS: Of 64 participants consented for the trial, 53 were evaluable for analysis. Fifty-five percent of participants reported that the journal was at least moderately useful. These participants were more likely to report improved communication scores ( P = .027), symptom management ( P = .011), and quality of life (QOL) ( P = .019). Participants who received the journal early were less likely to report a decrease in QOL as compared with the late journal group ( P = .757 v P = .035). CONCLUSION: To our knowledge, this is the first prospective randomized trial evaluating the use of structured journaling as a low-cost means to improve treatment-related adverse event management and QOL in patients with sarcoma undergoing SACT. These promising results will need to be confirmed by additional studies.

The incompetent bicuspid aortic valve (BAV) can be repaired using various techniques. This study presents a prospective comparison of external and subcommissural aortic annuloplasty.Fifty consecutive patients (38 males, age: 43.9 ± 15.8 years) with BAV insufficiency with or without aortic dilatation underwent valve repair in a single institution. They were prospectively allocated to one of two groups based on the aortic annulus stabilization technique: 25 patients were operated on using the subcommissural annuloplasty (SCA) and 25 using the external complete annuloplasty (EA). Transthoracic echocardiography was performed in all patients before the operation and 1 and 3 years after the operation. Moreover, mortality and morbidity at 7 years were evaluated.In prospective echocardiographic comparison, EA was associated with smaller diameter of the aortic annulus (24.1 ± 2.6 mm vs. 25.8±2.1 mm, p .05) and lower mean and peak transvalvular gradients (7 ± 4 mmHg vs. 13 ± 4 mmHg, p = .02 and 15.3 ± 9.7 mmHg vs. 20.7 ± 5.6 mmHg, p = .03, respectively). No patients died or required reoperation due to recurrent insufficiency at 6,81 (interquartile range-0,17) years after the operation. The Kaplan-Meier actuarial freedom from aortic regurgitation (AR) grade =2 or gradient20 mmHg at 35.1 ± 3.6 months years was 96% (24 out of 25) for patients who had external annuloplasty and amounted to 76% (19 out of 25) for those who had SCA, p = .05).External annuloplasty performed during repair of the BAV is associated with better hemodynamics at medium-term follow-up compared to SCA.

OBJECTIVE Previous research indicated that the International Committee of Medical Journal Editors guidelines of prospective trial registration with clearly identified primary and secondary outcome measures are only adhered to in 14.4% of studies published in the top five psychiatry journals between 1 January 2009 and 31 July 2013. This study examined if adherence has improved. METHODS The registration information, article information, primary outcome measures (POMs), participant numbers and funding source were extracted from studies published in the same five psychiatry journals between 1 January 2015 and 31 December 2019. Discrepancies between POMs in the articles and registry were tracked. RESULTS Of the 7268 publications, 268 studies required registration. Three (1.1%) were unregistered, 107 (39.9%) were retrospectively registered, and 158 (58.9%) were prospectively registered. Of the 158 prospectively registered studies, 16 (10.1%) had unclear POMs in the article or registration, 22 (13.9%) had discrepancies between registered and published POMs, and 33 (20.9%) had no POM discrepancies but had retrospectively updated POMs in the registry. Of the 22 studies with discrepancies, nine (40.9%) were determined to favour statistically significant results. Overall, 87 (32.5%) of the 268 studies were prospectively registered with no discrepancies between registered and published POMs and no changes to registered POMs or timeframes. CONCLUSION Although this rate of one third of published articles fully adhering to the guidelines is an improvement compared to previous research, further efforts still need to be made by both authors and journals to ensure full transparency in the reporting of studies in psychiatry.

Objectives To compare the effect of eldecalcitol and alfacalcidol on skeletal microstructure by high-resolution peripheral QCT (HR-pQCT). Methods This was a substudy of a randomized, double-blind, active comparator trial. Five female osteoporotic patients with 1-year 0.75 μg/day eldecalcitol and 5 with 1-year 1.0 μg/day alfacalcidol completed HR-pQCT scans before and after treatment were enrolled. Results Total vBMD [1.67 ± 1.06% (mean ± SD), P = 0.043 versus baseline] and trabecular vBMD (2.91 ± 1.72%, P = 0.043) at the radius increased in eldecalcitol group, while total, trabecular, and cortical vBMD tended to decrease in alfacalcidol group, with a significant reduction in cortical vBMD at the tibia (0.88 ± 0.62%, P = 0.043). Cortical area (1.82 ± 1.92%, P = 0.043) at the radius and thickness (0.87 ± 1.12%, P = 0.043) at the tibia increased in eldecalcitol group, while these parameters decreased with alfacalcidol at the tibia (1.77 ± 1.72%, P = 0.043 for cortical area; 1.40 ± 2.14%, P = 0.042 for cortical thickness). Trabecular thickness at the radius (1.97 ± 1.93%, P = 0.042) and number at the tibia (3.09 ± 3.04%, P = 0.043) increased by eldecalcitol but did not increase by alfacalcidol. Trabecular separation decreased by eldecalcitol (2.22 ± 2.43%, P = 0.043) but tended to increase by alfacalcidol at the tibia. Conclusions Eldecalcitol has the greater potential to improve cortical and trabecular microstructure at the peripheral bone than alfacalcidol which needs further more studies.

Objective: Debridement, the removal of nonviable tissue, forms the foundation of wound care practice. Clinicians have a variety of debridement methods at their disposal: sharp, biologic, enzymatic, autolytic and mechanical. The choice of debridement technique depends on the patient care setting, ulcer type and the clinician's experience, training, comfort level and licensure. This prospective study evaluated a novel debridement instrument, EZ-Debride (MDM Ventures, US). Cutting flutes on the head of the tool permit uniform removal of dead tissue while lessening the risk of deeper injury. It may also minimise pain during the debridement procedure. Method: Subjects with hard-to-heal wounds, drawn from a single wound care centre, participated in this institutional review board-approved prospective clinical study. Pain was measured before, during and after debridement using a numerical scale. Assessment of bacterial burden using fluorescence imaging (MolecuLight, Canada) was performed before and after debridement. Results: Enrolment of 10 male and 12 female subjects, with a total of 28 wounds, was carried out over a two-month period by two investigators at a single institution. The average age of subjects was 64 years (range: 22–95 years). The average wound duration was 29 weeks (range: 6–142 weeks). Wound types included diabetic foot, venous leg and pressure ulcers, post-surgical and traumatic wounds. The average pain score at the time of enrolment was 3.9. Subjects reported an average increase in pain with debridement of 0.6 points (range: 0–8). Fluorescence imaging demonstrated a reduction in bacterial load in 69% of cases, with complete resolution in 19% of wounds. Haemostasis was achieved with direct pressure in all cases and the only adverse event was a wound infection that occurred four days after debridement. Conclusion: The results suggest that this novel debridement tool can safely remove nonviable tissue with minimal discomfort and reduce bacterial burden similar to results achieved by sharp debridement.

Background The coronavirus SARS-CoV-2 is highly contagious. Hydroxychloroquine (HCQ) has in vitro activity against SARS-CoV-2. The FDA authorized emergency use of HCQ against COVID-19. HCQ may have dose-related cardiotoxicity. This clinical trial received ethical approval on May 15, 2020, operationalized in June to evaluate a low prophylaxis dose of HCQ (200mg BID) in household contacts of COVID-19-positive patients without physical contact between investigators and participants. It represents the first report of the FDA approved 6-lead EKGs with a smartphone KardiaMobile® 6L application. Methods To reach a sample size of 170, household members were contacted by telephone, emailed consent forms with electronic signature capability, and randomized 2:1 to HCQ or observation for 10 days with follow-up of 14 days. Home saliva PCR tests recorded COVID status on days 1 and 14. Symptoms and 6-lead EKGs were obtained daily. Results Fifty-one participants were randomized with 42 evaluable at day 14. Remote monitoring of 407 EKGs revealed no QTc prolongation or other ECG changes in either group. At time of consent, no participants were symptomatic or COVID+. On days 1 and 14, COVID tests were positive in 4 and 2 in the HCQ group and 4 and 0 in the observation group. No tests converted to positive. There were no deaths or hospitalizations. Conclusions A clinical trial without personal contact, rapidly initiated and operationalized to exclude cardiac toxicity using daily remote 6-lead EKG monitoring, is feasible. Of 407 EKGs from 42 participants, there was no evidence of cardiac toxicity. Clinical trial registration Clinicaltrials.gov: NCT04652648 registration date: December 3, 2020

The primary objective was to evaluate the efficacy and safety of Er:YAG laser treatment for meibomian gland dysfunction (MGD) in a prospective study. A total of 128 eyes from 64 patients with MGD were enrolled to receive either three Er:YAG laser treatments with meibomian gland expression (MGX) or MGX-alone treatment sessions at 3-week intervals. The Standard Patient Evaluation of Eye Dryness (SPEED) validated questionnaire; fluorescein breakup time of the tear film (FBUT); corneal fluorescein staining (CFS); lid margin abnormalities; meibomian gland morphology (meiboscore); lower tear meniscus height (TMH); and assessment of 15 meibomian glands in the lower eyelids, including total meibomian gland secretion quality (TMGS), the number of glands secreting any liquid (GSAL), and the number of glands yielding optimal clear liquid secretion (GYCL), were assessed at day (D)0, D21, D42, and D63 for the Er:YAG-MGX group and D0 and D63 for the MGX group. At D63, significant decreases in SPEED scores and lid margin abnormalities as well as significant increases in FBUT, TMGS, and GSAL were observed in both groups (all p

Objective: a Researchers have a duty to make the results of their research available publicly. According to the FDA, clinical trial data must be made public less than 12 months after the end of the trial. The trialstracker website ( https://trialstracker.ebmdatalab.net/#/ ) ranks sponsors according to the proportion of unpublished clinical trials by extracting data from a prospective trial registry: clinicaltrials.gov. A low proportion of published trials could be explained by a failure to share results or the sponsor incorrectly filling out the clinicaltrials.gov database. The objective of this study was to assess for which of these reasons one academic sponsor was shown to have a high proportion of unpublished results. Methods: Bibliographic searches were performed and followed up with an email contact for the 104 HCL (Hospices Civils de Lyon, France) trials used by trialstracker to assess publication status. Results: Trialstracker considered that only 25 out of the 104 HCL trials had been published. By searching PubMed between February and April 2019, we rapidly identified publications for 27 further trials. A more advanced search and contact with the investigators allowed us to identify 24 more published trials. Overall, the proportion of trials published was 72.1% (n = 75) i.e. 3 times higher than the proportion provided by trialstracker. Even when restricted to the results found via a simple search, the proportion of publications was still higher with a two-fold increase. Conclusion: We found that trialstracker greatly underestimated the number of publications. All actors should therefore contribute to improving the visibility of clinical trial results by providing NCT numbers for all publications (investigator), and by updating clinicaltrials.gov (sponsor and investigator).

Radiosynovectomy (RS) with 90Y-hydroxyapatite (90Y-HyA) aims to control knee hemarthrosis in hemophiliac patients to prevent secondary arthropathy. However, knee RS using 153Sm-hydroxyapatite (153Sm-HyA) is considered less suitable due to the lower average soft tissue range and energy of 153Sm for large joints, such as the knees. The objective of this investigation was to assess the efficacy and safety of knee RS with 153Sm-HyA, compared to 90Y-HyA. Forty patients were prospectively assigned to undergo knee RS with 153Sm-HyA (n = 19) or with 90Y-HyA (n = 21). The frequency of hemarthrosis episodes before and after treatment were compared. After six months of knee RS, 153Sm-HyA and 90Y-HyA promoted a similar reduction of hemarthrosis episodes (50% and 66.7%, respectively). However, after 12 months of knee RS, the reduction of hemarthrosis episodes was significantly (p = 0.037) higher using 153Sm-HyA (87.5%) compared to 90Y-HyA (50.0%). This discrepancy was more pronounced (p = 0.002) for 153Sm-HyA compared to 90Y-HyA in adults/adolescents. Knee radiosynovectomy with 153Sm-HyA is safe, reduces hemarthrosis episodes after 12 months of treatments, especially in adults/adolescents and even with grades III/IV arthropathy, similar to 90Y-HyA. 90Y-HyA seems to promote better hemarthrosis control in small children.

Introduction: Programming directional leads poses new challenges as the optimal strategy is yet to be established. We designed a randomized control study to establish an evidence-based programming algorithm for patients with Parkinson’s disease undergoing subthalamic nucleus deep brain stimulation with directional leads. Methods: Fourteen consecutive patients were randomized to programming with either early or delayed (i.e., starting with a “ring mode”) steered stimulation. Motor scores, number of programming visits, calls to the clinic, battery consumption, and stimulation adjustments required were recorded and compared between groups, using the Wilcoxon signed-ranks test, after 3 months of open-label programming. Results: Thirteen patients (25 electrodes) were included, of which 23 were steerable. Nine out of 14 electrodes allocated to delayed steered stimulation were changed to steered mode due to side effects during the course of the study. No patients (11 electrodes) initially allocated to early steered stimulation were converted to ring mode. The 2 study arms did not differ in any of the considered measures at 3 months. Conclusion: Programming with early or delayed steered stimulation is equally effective in the short term. However, delayed steering is less time consuming and is not always needed.

PURPOSE: This prospective trial’s objective was to determine feasibility and outcomes of an exercise-based intervention for rural overweight/obese female cancer survivors. MATERIALS AND METHODS: Survivors of endometrial, breast, or ovarian cancer enrolled in a 6-month program of increased aerobic activity (30 minutes daily walking) and strength-training exercises using exercise bands (THERABAND; Akron, OH) with personalized telephone motivational coaching. Baseline demographics, anthropomorphic measurements, quality of life (QOL), fitness, and readiness to adopt exercise changes were assessed; daily steps, band use, and follow-up measurements were assessed at 3 and 6 months. Study completion was modeled using logistic regression. RESULTS: The mean age of the 99 women was 59.9 years, the mean body mass index (BMI) was 35.9 kg/m2, 88.9% were white, and 41.4% reported current exercise. Fifty-five women (55.6%) completed the 6-month program, and 36 (36.4%) completed exercise interventions. Using logistic regression to model study completion, only baseline QOL scores (physical component summary) and mental component summary) remained significant predictors. The mean weight change was a gain (0.88 kg). Higher MCS baseline scores and prior regular exercise predicted continued exercise and increased step counts, whereas higher BMI and baseline sleep predicted decreased QOL. Top walking barriers were feeling unwell and weather; barriers to strength exercises were band dislike and pain. CONCLUSION: The most significant predictor of trial completion and improved exercise outcomes was a higher baseline mental QOL. Motivation, belief in the importance of exercise, and prescribed/monitored exercise regimens were not sufficient; supportive and cognitive behavioral therapy interventions for survivors are needed to sustain uptake.

Objective : The ideal controlled ovarian stimulation protocol for patients with poor ovarian response (POR) is not clear yet, and is the subject of many studies. Aromatase inhibitors have been introduced as a new treatment modality in controlled ovarian stimulation as they were found to elevate follicular sensitivity to gonadotropins(Gn). The aim of this study was to evaluate whether it is possible to reduce the required Gn dose by adding letrozole to the treatment without compromising success. Material and Methods: Patients who underwent in vitro fertilization treatment between 2014 and 2015 in our department and who were classified as poor responder patients according to Bologna criteria were recruited and randomized. In the first group, 33 patients were treated with 150 IU Gn in combination with letrozole 5 mg /day for the first five days of the stimulation. In the second group, 27 patients were treated with 300 IU Gn. Results: Amoung the groups there were no statistically significant difference in duration of ovulation stimulation, duration of antagonist use, number of retrieved oocytes, number of transferred embryos, implantation, cycle cancelation, chemical, clinical and ongoing pregnancy rates (all p>0.05). Gn use was significantly higher in 300 IU Gn alone group compared to 150 IU Gn in combination with letrozole group (1354 ± 468 IU versus 2555 ± 725 IU, p

Objective: To compare the outcomes of ureteroscopic lithotripsy with pneumatic lithotripter versus Holium:Yttrium-Aluminum-Garnet (Ho:YAG) laser in the management of upper ureteric stones. Materials and methods: Patients who underwent ureteroscopic lithotripsy with pneumatic lithotripter or Ho:YAG laser for upper ureteric stones were reviewed. Patients with urinary tract infection, ,loss of follow-up, concurrent middle or lower third ureteral stones or acute renall failure were excluded. Patient age, stone size and burden (based on KUB or computerized tomography), stone upward migration, double J stent insertion rate, stone free rate and secondary intervention rate for residual stones were compared in both groups. Results: There were 70 patients with upper ureteric stones (35 in pneumatic group and 35 in laser group) meeting the study criteria. Patients’ age, gender, stone size and burden were similar in both groups. The Ho:YAG laser lithotripsy group had better stone free rate, less double J stent insertion rate and less upward migration and secondary intervention rate, sepsis as compared with pneumatic lithotripsy (94.2% vs. 60%; 85% vs. 100%; 5.7% vs 40%; 5.7% vs 34.2%; 2.8 vs 2.8 respectively, all p < 0.05). In patients with stones sizes 8-10 mm, Ho:YAG laser lithotripsy had significantly lower upward migration rate, lower double J stent insertion rate, higher stone free rate and less secondary intervention rate. Conclusions: Ho:YAG laser lithotripsy is better and much effective than pneumatic lithotripsy in the management of upper ureteric stones in terms of, stone free rate and secondary intervention rate for stones of sizes about 8 to 10 mm.Although the access of upper ureter is difficult but our small calibre (4.5 fr) ureteoscope and gentle manuevre have made the procedures safe and successful. Bangladesh Journal of Urology, Vol. 23, No. 2, July 2020 p.188-192

Purpose We investigated in a single-center prospective trial (NCT03376386) the use of serial fluorine-18 fluorodeoxyglucose positron emission tomography (FDG-PET)/computed tomography (CT) to determine the boost dose and to guide boost segmentation in head and neck cancer. Methods and Materials Patients were eligible when treated with curative radiation therapy with or without systemic treatment for T2-4 squamous cell carcinoma of the hypopharynx, larynx, or oropharynx (20 patients in total). FDG-PET/CT scans were made at baseline and for redelineation and replanning at the end of weeks 2 and 4 of radiation therapy. The metabolically active part of the primary tumor received a 4 Gy boost on top of the 70 Gy baseline dose per partial metabolic response. The study would be considered feasible when ≥80% of adaptations were successful and no Common Terminology Criteria for Adverse Events grade ≥4 acute toxicity occurred. Results One patient received 70 Gy after complete metabolic response in week 2, and 12 patients received 78 Gy because of partial metabolic response at weeks 2 and 4. Seven patients received 74 Gy, either because of complete metabolic response at week 4 (n = 3) or a missed FDG-PET/CT (n = 4). The patients missed their FDG-PET/CT scans because they did not fast (n = 2) or at patients’ request (n = 2). In addition to the 4 missed FDG-PET/CT scans, 2 adaptive plans could not be finished successfully owing to logistical problems. In total, 85% of adaptations were completed correctly. No patient experienced grade ≥4 toxicity, and 40% had grade 3 dysphagia (tube feeding) during treatment. This decreased at 12 weeks posttreatment to 20%. Conclusions This prospective trial demonstrates the feasibility of serial FDG-PET/CT scans for dose escalation and patient selection.

Aim To evaluate the effect of the Valsalva maneuver on ease of the endometrial sampling procedure in cases where the cervix cannot be passed spontaneously. Methods A randomized prospective trial was conducted in 84 patients whose cervix could not pass spontaneously with pipelle, and they were randomized for the Valsalva maneuver or tenaculum groups. In 43 of a total of 84 patients, we requested Valsalva maneuver throughout the process to pass the cervical canal, and in 41 patients, we performed tenaculum to pass the cervix. Results Valsalva and tenaculum groups did not differ in success rates (P = 0.314). There was no difference between the two groups in the history of the disease, past surgery and education (P > 0.05). Conclusion In endometrial sampling procedure with pipelle, when the cervix cannot be passed spontaneously, the transition with the Valsalva maneuver should be tried before using the tenaculum. Thus, a more painful procedure can be avoided and patient satisfaction may increase.

Aims The study was undertaken to compare the efficacy of Woodcast splints and plaster-of-Paris casts in maintaining correction following sequential manipulation of idiopathic clubfeet. Methods In this randomized prospective trial, 23 idiopathic clubfeet were immobilized with plaster-of-Paris casts and 23 clubfeet were immobilized with a splint made of Woodcast that encircled only two-thirds the circumference of the limb. The number of casts or splints needed to obtain full correction, the frequency of cast or splint-related complications, and the time taken for application and removal of the casts and splints were compared. Results The mean number of casts required to obtain full correction of the deformity (Pirani Score 0) was 4.35 (95% confidence interval (CI) 3.74 to 4.95) when plaster-of-Paris was used and 4.87 (95% CI 4.33 to 5.41) when the Woodcast splint was used (p = 0.190). The time required for application and removal of the Woodcast splint were significantly less than that required for application and removal of plaster-of-Paris casts (p < 0.001). Woodcast splint-related complications were not more frequent than plaster-of-Paris cast related complications. Conclusion Though Woodcast splints covering two-thirds of the circumference of the lower limbs of infants were effective in maintaining the correction of clubfoot deformity during serial manipulation and casting treatment, the superiority of Woodcasts over plaster-of-Paris could not be established. Cite this article: Bone Joint J 2020;102-B(10):1399–1404.

Objectives Preoperative grading of pancreatic neuroendocrine tumors (PanNET) is challenging. The aim of this study was to prospectively evaluate the use of a 25-gauge needle with a core trap for diagnosis and grading of PanNET. Methods This multicenter prospective trial was registered with the University Hospital Medical Information Network (UMIN000021409). Consecutive patients with suspected PanNET between June 2016 and November 2017 were enrolled. All patients underwent endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) using a 25-gauge needle with a core trap. Samples obtained after the first needle pass were used for central pathological review. EUS-FNB was evaluated in terms of (i) technical success rate, (ii) adequacy for histological evaluation, (iii) complication rate during the procedure, and (iv) concordance between PanNET grading on EUS-FNB and that after analysis of the resected tumor. Results Fifty-two patients were enrolled. Of the 36/52 patients who underwent surgical resection, 31 were finally diagnosed with PanNET and were eligible for analysis. The technical success rate of EUS-FNB was 100%. The rate of adequacy for histological evaluation was 90.3%. There were no complications related to EUS-FNB. The concordance rate between PanNET grading on EUS-FNB and that after analysis of the resected tumor was 82.6% (95% confidence interval = 61.22–95.05, P = 0.579). Conclusions EUS-FNB using a 25-gauge needle with a core trap is feasible, providing histological samples are of sufficient quality for diagnosis and grading of PanNET.

Objective. The role of the GLCCI1 gene polymorphism (rs37973) analysis in children with bronchial asthma (BA). Methods. The study involved 60 children 3-17 years old with allergic (n=37) and mixed forms of BA (n=23). The genetic study included performing genotyping of the studied locus of the GLCCI1 gene (rs37973) by PCR-RFLP (polymerase chain reaction – restriction fragment length polymorphism). Results. Analysis of the frequency of genotypes and alleles occurrence established the predominance of heterozygotes (AG) and allele G in the study group. There were statistically significantly higher indices of VC, FVC, FEV1 and MEF75 (according to spirometry data) with a heterozygous genotype (AG) in comparison with a homozygous GG (p

We conducted a multicenter, randomized, double-blind, placebo-controlled prospective trial examining a supplement containing ferulic acid and Angelica archangelica extract (Feru-guard ®) for mild cognitive impairment (MCI). In the intention-to-treat population, Mini-Mental State Examination (MMSE) scores were significantly better at 24 weeks (p = 0.041) in the active group. In the per protocol population, MMSE was significantly better in the active group at 24 weeks (p = 0.008), and mixed effect models for repeated measures (MMRM) showed significant difference (p = 0.016). ADAS-Jcog was significantly better at 24 (p = 0.035) and 48 weeks (p = 0.015) in the active group, and MMRM was significant (p = 0.031). Thus, Feru-guard ® may be useful for MCI.

Objective: To compare two commercially available ureteral access sheaths in their ability to access the renal collecting system and assess ureteral wall trauma using a prospective, randomized trial...

Highlights • Prostate cancer T3a disease is a very heterogeneous entity. • Patients presenting major factors of T3a disease are at higher risk of biochemical failure and metastases., MRI-detected T3a prostate cancer is a heterogeneous disease. This post-hoc analysis of a prospective trial found that patients with T3a disease presenting obliteration of the recto-prostatic angle, contact-asymmetry of neuro-vascular bundle and periprostatic fat invasion, may be at higher risk of biochemical failure and metastases.

Historically, the presence of cardiac implantable electronic devices (CIEDs), including pacemakers and implantable cardioverter defibrillators (ICDs), was widely considered an absolute contraindication to magnetic resonance imaging (MRI). The recent development of CIEDs with MR Conditional labeling, as well as encouraging results from retrospective studies and a prospective trial on the safety of MRI performed in patients with CIEDs without MR Conditional labeling, have led to a reevaluation of this practice. The purpose of this report is to provide a concise summary of recent developments, including practical guidelines that an institution could adopt for radiologists who choose to image patients with CIEDs that do not have MR Conditional labeling. This report was written on behalf of and approved by the International Society for Magnetic Resonance in Medicine (ISMRM) Safety Committee. LEVEL OF EVIDENCE: 3. TECHNICAL EFFICACY STAGE: 1.

ObjectiveThis trial compared the efficacy and safety of transarterial chemoembolisation (TACE) plus sorafenib with TACE alone using a newly established TACE-specific endpoint and pre-treatment of sorafenib before initial TACE.DesignPatients with unresectable hepatocellular carcinoma (HCC) were randomised to TACE plus sorafenib (n=80) or TACE alone (n=76). Patients in the combination group received sorafenib 400 mg once daily for 2–3 weeks before TACE, followed by 800 mg once daily during on-demand conventional TACE sessions until time to untreatable (unTACEable) progression (TTUP), defined as untreatable tumour progression, transient deterioration to Child-Pugh C or appearance of vascular invasion/extrahepatic spread. Co-primary endpoints were progression-free survival (PFS), which is not a conventional one but defined as TTUP, or time to any cause of death plus overall survival (OS). Multiplicity was adjusted by gatekeeping hierarchical testing.ResultsMedian PFS was significantly longer in the TACE plus sorafenib than in the TACE alone group (25.2 vs 13.5 months; p=0.006). OS was not analysed because only 73.6% of OS events were reached. Median TTUP (26.7 vs 20.6 months; p=0.02) was also significantly longer in the TACE plus sorafenib group. OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively. There were no unexpected toxicities.ConclusionTACE plus sorafenib significantly improved PFS over TACE alone in patients with unresectable HCC. Adverse events were consistent with those of previous TACE combination trials.Trial registration numberNCT01217034.

Background Shared decision making (SDM) preceding lung cancer screening is important for populations that are underrepresented in lung cancer screening trials. Current evidence-based guidelines; however, do not address personal risk and outcomes in underrepresented populations. This study compared two SDM decision aids (Option Grids and Shouldiscreen.com) for SDM efficacy, decision regret and knowledge. Methods We conducted a prospective trial of lung cancer screening patients (N = 237) randomized to SDM with Option Grids or Shouldiscreen.com. To evaluate the SDM process after lung cancer screening, patients answered two questionnaires: CollaboRATE and Decision Regret. Patients also completed a questionnaire to test their knowledge of lung cancer screening. Results Patients were predominantly African American (61.6%), though multiple races, varying education levels and equal genders were represented. Patients in both Option Grids and Shouldiscreen.com groups reported favorable SDM experiences (P = 0.60) and equivalent knowledge about lung cancer screening (P = 0.43). Patients using Shouldiscreen.com had less knowledge regarding the potential complications of subsequent testing (P = 0.02). Shouldiscreen.com patients had increased regret regarding their decision to pursue screening (P = 0.02). Conclusions Option Grids and Shouldiscreen.com both facilitated a meaningful SDM process. However, Option Grids patients experienced decreased decision regret and enhanced knowledge of the potential complications of screening.

There are many treatments for neck laxity and fullness, both invasive and noninvasive. The purpose of this study was to evaluate the effectiveness of combined infrared, radiofrequency, mechanical massage, and suction therapy in performing contour changes in the submental and lateral neck regions. This was a single-center, prospective cohort study in which 30 patients were treated with a session of combined infrared, radiofrequency, mechanical massage, and suction therapy once a week for 4 weeks. Follow-up was performed at posttreatment months 1, 3, and 6. Both subjects and investigators completed submental fat grading scales and lateral neck and jowl linear analog scales. Exclusion criteria included history of soft tissue augmentation, cosmetic injections, ablative or nonablative skin resurfacing, or surgical procedures in the lower facial region, as well as weight gain or loss exceeding 10 pounds during the study period. There was a significant difference between mean ± SD neck and jowl investigator scores at day 0 and month 6, which were 5.6 ± 0.9 and 4.4 ± 1.0, respectively ( P < .05). Mean investigator submental fat score at day 0 was 1.9 ± 0.7 vs 1.5 ± 0.6 ( P = .04) at month 6. Differences between mean patient neck and jowl and submental fat scores were also statistically significant between day 0 and month 6. At day 0, the mean patient neck and jowl score was 4.7 ± 0.8 vs 3.2 ± 1.1 at month 6 ( P < .05), and at day 0, the mean patient submental fat score was 2.2 ± 0.5 vs 1.8 ± 0.6 at month 6 ( P < .05). Combined infrared, radiofrequency, mechanical massage, and suction therapy provides an effective, noninvasive treatment modality for improving contour of the lateral neck and submentum.

Aim of the study Since over 80% of sudden cardiac arrests occur in the home, cardiopulmonary resuscitation (CPR) training for family members of high-risk cardiac patients represents a promising intervention. The use of mobile application-based (mApp) CPR training may facilitate this approach, but evidence regarding its efficacy is lacking. Methods We conducted a multicenter, pragmatic, cluster-randomized trial assessing CPR training for family members of cardiac patients. The interventions were mApp (video, no manikin) and VSI (video + manikin). CPR skills were evaluated 6-months post-training. We hypothesized that chest compression (CC) rate from training with an mApp would be no worse than 5 compressions per minute (CPM) lower compared to VSI. Results From 01/2016 to 01/2018, we enrolled 1325 eligible participants (mean age 51.6 years, 68.2% female and 59.4% white). CPR skills were evaluated 6-months post-training in 541 participants (275 VSI, 266 mApp). Mean rate was 84.6 CPM (95% CI: 80.4, 88.6) in VSI, compared to 82.7 CPM (95% CI: 76.2, 89.1) in the mApp, and mean depth was 42.1 mm (95% CI: 40.3, 43.8) in VSI, compared to 38.9 mm (95% CI: 36.2, 41.6) in the mApp. After adjustment, the mean difference in CC rate was −2.3 CPM (95% CI −9.4, 4.8, p = 0.25, non-inferiority) and CC depth was −3.2 mm (95% CI −5.9, 0.1, p = 0.056). Conclusion In this large prospective trial of CPR skill retention for family members of cardiac patients, mApp training was associated with lower CC quality. Future work is required to understand additional approaches to improve CPR skill retention. Clinical Trial Registration URL: ClinicalTrials.gov, Identifier: NCT02548793 .

Background Prior trials provide strong evidence supporting minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. Objective To assess the safety and effectiveness of SIJF using a 3D-printed TTI. Methods Fifty-one subjects with carefully diagnosed SIJ dysfunction underwent SIJF with 3D TTI. Subjects completed pain, disability and quality of life questionnaires at baseline and 3, 6 and 12 months postoperatively. Functional tests were performed in the clinic at each visit. Pelvic CT scans were independently evaluated for radiolucency, bridging bone and other endpoints. Results Ninety percent had 12-month follow-up. Dysfunction due to pain (Oswestry Disability Index [ODI]) decreased from 52.8 at baseline to 27.9 at 12 months (p

To assess the outcome of a novel method of preventing facial pressure ulcers in spinal surgery and a review of literature. A prospective trial using a novel method of facial protection using paraffin tulle gras dressing to cover bony prominences during spinal surgical procedures was performed. Patients were reviewed at 24 hours and 6 weeks. A telephone survey was also conducted post discharge. Over an 8-month period, 12 patients (7F:5M, age 9-72 years) underwent spine surgery for tumour stabilisation (n = 7), deformity correction (n = 4), and degenerative presentation (n = 1) with mean operative time of 472 minutes (range 150-785 minutes) in prone position. All patients were managed by the same team using an agreed protocol. No pressure ulcers were noted in our study. One patient sustained minimal erythema, which resolved after 24 hours. All patients were satisfied with the care received. Facial pressure ulcers though much reduced are still common in spinal surgery. The common factors are the long duration of surgery, shear, friction, moisture, and intrinsic factors. Our strategy of an appropriate facial support and constant vigilance helped eliminate the incidence of iatrogenic facial ulcers in spinal surgery.

Background: This study compared the intensity of blood-aqueous barrier breakdown in diabetic patients after phacoemulsification with heparin surface-modified and non-modified intraocular lens (IOL) implantation. Material and methods: In this prospective trial, 68 diabetic patients were enrolled and divided into two groups: 33 patients with heparin surface-modified IOL implants (group 1) and 35 patients with standard hydrophobic IOL implants (group 2). Blood-aqueous barrier breakdown was assessed using a Laser Flare Meter 1 day, 7 days, 14 days, 1 month, and 3 months postoperatively. Results: On postoperative days 1 and 7, the mean flare value was significantly higher in group 2 compared with group 1. On day 14, the mean flare value in both groups was similar and then higher in group 2. Conclusions: The implantation of foldable heparin-coated IOLs led to a lower intensity and faster recovery of blood-aqueous barrier breakdown postoperatively.

Anogenital skin care for the elderly remains an umbrella term concerning protective and non-interventional regimens, particularly for ordinary diaper users. Our recent investigation has demonstrated the preventive effect of daily anogenital washing with miconazole nitrate-containing soap to the development of diaper candidiasis. We extended this work to cover our hypothesis as to whether the miconazole soap has a therapeutic benefit in genital candidiasis. The study outline includes: (i) the enrollment of 21 bedridden inpatients (84 ± 9 years; eight men and 13 women) who were diagnosed clinically and mycologically with genital candidiasis, and who had never received topical and/or systemic antifungal agents; (ii) administration of anogenital washing with 0.75% miconazole-containing soap once daily for 4 weeks; and (iii) assessment of clinical symptoms and detection of Candida materials by culture and microscopic examination. As assessed by clinical symptom scoring for incontinence-associated dermatitis (IAD), the ratio of patients with severe to moderate symptoms dramatically decreased by 2 weeks and 10 of 21 patients became symptom-free at 4 weeks. The IAD clinical severity score was significantly decreased at 4 weeks. Compared with the baseline positivity, both microscopic and cultured Candida-positive rates were significantly decreased at 4 weeks after washing. All culture-detected fungi were Candida albicans. Severe adverse events did not occur in all participants. Individual medical and risk factors had no significant correlation with clinical severity and duration of candidiasis on variance analysis. In conclusion, topical washing with miconazole soap is a safe and reliable non-medical approach for soothing diaper-associated genital candidiasis in bedridden inpatients in whom it is difficult to perform prompt medical examination.

Objective To compare the management of large ureteric stones (>10 mm) with ureterorenoscopy (URS) and laser or pneumatic lithotripsy, and their associated costs. Patients and methods Our prospective study followed the tenets of the Declaration of Helsinki and included 101 patients with large mid-ureteric stones eligible for URS and lithotripsy, and was conducted between January 2018 and August 2019. Patients were randomly divided into two groups: Group 1 had laser lithotripsy, while the Group 2 had lithotripsy using a pneumatic energy source. Results Operative time was significantly longer in cases using pneumatic lithotripsy (P

In critically ill brain-injured patients maintaining balanced fluid management is a crucial part of critical care. Many factors influence the relationship between fluid management, cerebral blood flow and cerebral oxygenation. Passive leg raising (PLR)-induced changes predict fluid responsiveness in the majority of non-neurological ICU patients. In patients with intracranial lesions, PLR testing has been hypothesized to increase intracranial pressure (ICP), although data are lacking. We wanted to investigate the feasibility of PLR with expected intracranial pressure increase, according to the higher cerebral blood volume. This should be self-limiting in patients with intact cerebral autoregulation.We prospectively included patients with traumatic brain injury (TBI) or aneurysmal subarachnoid hemorrhage (aSAH) in this pilot trial. PLR was performed within 48 hours after the initial diagnosis and on days 5-8. All patients had ICP monitoring. Absence of intracranial hypertension (defined as ICP25 mm Hg) was considered a positive test result.Ten patients were recruited for this study. The cohort consisted of 6 male patients with TBI and 4 female patients with aSAH. Mean patient age was 55.6 years (range 35-76). Overall, 18 tests could be performed, of which only one had to be terminated due to temporarily elevated ICP. 9 out of 10 patients had no intracranial hypertension during the acute (mean ICP increase 8.45 mm Hg, range 4-16) or during the subacute phase (mean ICP increase 9.12 mm Hg, range 3-18).PLR is feasible in patients with intracranial pathology to assess fluid responsiveness and provide optimized patient volume management without increasing the risk of persistent intracranial hypertension.

Replacing salt with a modified substitute has a beneficial impact on cardiovascular outcomes, according to a large, prospective trial. Replacing salt with a modified substitute has a beneficial impact on cardiovascular outcomes, according to a large, prospective trial.

Objectives: In our previous prospective trial on accelerated hypofractionated concomitant radiochemotherapy (AHRT-CHT) for non-small-cell lung cancer (NSCLC), the incidence of grade ≥3 acute esophageal toxicity (AET) was similar to that reported for conventionally fractionated concomitant radiochemotherapy (CFRT-CHT), but its duration was prolonged. Thus, we aimed to compare the duration of grade ≥3 AET between AHRT-CHT and CFRT-CHT. Methods: Clinical data of 76 NSCLC patients treated with CFRT-CHT (60–66 Gy/2 Gy) during 2015–2020 were retrospectively compared with the data of 92 patients treated with AHRT-CHT (58.8 Gy/2.8 Gy) in the prospective trial. The maximum grade of AET, incidence, and duration of grade ≥3 AET were the end points. Univariate and multivariate analyses were applied to correlate clinical and treatment variables with these end points. Results: Neither the maximum grade of AET (p = 0.71), nor the incidence of grade ≥3 AET (p = 0.87) differed between the two groups. The number of CHT cycles delivered (2 vs 1, p = 0.005) and higher esophagus mean BED (p = 0.009) were significant predictors for a higher maximum grade of AET; older age was a significant predictor for higher incidence of grade ≥3 AET (p = 0.03). The median duration of grade ≥3 AET in AHRT-CHT and CFRT-CHT group was 30 days (range 5-150) vs 7 days (range 3–20), respectively, p = 0.0005. In multivariate analysis, only the AHRT-CHT schedule (p=0.003) was a significant predictor for a longer duration of grade ≥3 AET. Conclusion Despite similar incidence of grade ≥3 AET, its duration is significantly prolonged in NSCLC patients treated with AHRT-CHT compared to CFRT-CHT. Advances in knowledge Reporting only the rate of grade ≥3 AET in clinical trials may underestimate the real extent of the esophageal toxicity; its duration should also be routinely reported.

High dose therapy and autologous hematopoietic cell transplantation (HCT) remains the standard of care for relapsed patients with non-Hodgkin Lymphoma...

Optimal therapeutic strategy in low advanced papillary thyroid carcinoma (PTC) is still a matter of debate. The management differs depending on the country.A prospective non-randomized study was performed to evaluate whether less extensive surgery could be a safe, acceptable, and sufficient therapeutic option in PTC cT1N0M0 patients. The present paper summarizes the results of over a 5-year follow-upMaterialOur prospective group (PG) treated between 2011 and 2015 consisted of 139 patients with cT1aN0M0 PTC who underwent lobectomy (LT) as initial surgical treatment (PGcT1aN0M0 group) and 102 cT1bN0M0 patients in whom total thyroidectomy (TT) with unilateral central neck dissection (CND) was performed (PGcT1bN0M0). PG was compared with the retrospective group (RG) of patients who underwent TT with bilateral CND between 2004 and 2006: 103 cT1aN0M0 patients (RGcT1aN0M0) and 91cT1bN0M0 (RGcT1bN0M0). The risks of reoperation, cancer relapse and postoperative complications were analyzed.ResultsOnly 12 cT1aN0M0 patients (7.6%) withdrew from the trial and underwent TT with bilateral CND. Over 90% of patients accepted less extensive surgery. In 4 cT1aN0M0 cases, TT with CND was performed due to lymph node metastases found intraoperatively. The initial clinical stage according to the TNM/AJCC 7th edition was confirmed histologically in 77% of cases in PGT1aN0M0 and in 72% in PGT1bN0M0, respectively. 24 PGcT1aN0M0 patients were reoperated on. In this group, cancer lesions in the postoperative histological specimens were found in 8 cases (32%). Five-year disease-free survival (DFS) was excellent. However, no statistically significant differences were found between PG and RG groups (99.3% in PGcT1aN0M0 and 99.0%, in RGcT1aN0M0; p = 0.41 and 98%, in PGcT1bN0M0 and 94.4% in RGcT1bN0M0; p=0.19). No significant differences were observed in the incidence of early paresis of the recurrent laryngeal nerves between PG and RG. However, as predicted, LT completely eliminated the risk of postoperative hypoparathyroidism.SummaryThe results of the prospective clinical trial confirm that less extensive surgery in adequately selected low-advanced PTC patients is both safe and sufficient.

INTRODUCTION AND OBJECTIVE:To compare perioperative and post-operative outcomes for holmium laser enucleation of the prostate (HoLEP) between cases performed with a 550um standard laser fiber versu...

INTRODUCTION AND OBJECTIVE:We report the twelve-month results of a multicenter, single arm trial of water vapor thermal therapy in men with symptomatic lower urinary tract symptoms due to benign pr...

Introduction: To minimize the radiation exposure of mostly young testicular cancer patients, it is essential to find out whether CT could be replaced by magnetic resonance imaging (MRI) in the stag...

Background Chronic obstructive pulmonary disease (COPD) is the fifth leading cause of death in China with a reported prevalence of 8.2% people aged ≥40 years. It is recommended that Chinese physicians follow Global Initiative for Chronic Obstructive Lung Disease (GOLD) and national guidelines, yet many patients with COPD in China remain undiagnosed. Furthermore, missed diagnoses and a lack of standardized diagnosis and treatment remain significant problems. The situation is further complicated by a lack of large-scale, long-term, prospective studies of real-world outcomes, including exacerbation rates, disease severity, efficacy of treatment, and compliance of COPD patients in China. Methods/design The REALizing and improving management of stable COPD in China (REAL) study is a 52-week multi-center, prospective, observational trial. REAL aims to recruit approximately 5000 outpatients aged ≥40 years with a clinical diagnosis of COPD per GOLD 2016. Outpatients will be consecutively recruited from approximately 50 tertiary and secondary hospitals randomly selected across six geographic regions to provide a representative population. Patients will receive conventional medical care as determined by their treating physicians. The primary objective is to evaluate COPD patient outcomes including lung function, health status, exacerbations, hospitalization rate, and dyspnea following 1 year of current clinical practice. Secondary objectives are to assess disease severity, treatment patterns, adherence to medication, and associated risk factors. Data will be collected at two study visits, at patients’ usual care visits, and by telephone interview every 3 months. Discussion Knowledge of COPD among physicians in China is poor. The REAL study will provide reliable information on COPD management, outcomes, and risk factors that may help improve the standard of care in China. Patient recruitment began on 30 June 2017 and the estimated primary completion date is 30 July 2019. Trial registration ClinicalTrials.gov identifier: NCT03131362. Registered on 20 March 2017.

Summary. Retro- and prospective trial was based on data about 30 patients, suffering entero-colocutaneous fistula, who were treated in the Shalimov National Institute of Surgery and Transplantology during 2016-2019. There was revealed, that the most informative phenotypical markers of undifferentiated dysplasia of the connective tissue (UDCT) in patients, with entero-colocutaneous fistula, are visceral (83,3%), vascular (70%), arrhythmic (70%) syndromes. There was founded, that direct correlation between the level of biochemical markers of the collagen biodegradation and the UDCT degree may be applied for prognostication of development and course of complications in patients, suffering entero-colocutaneous fistula. Severe degree of UDCT in the patients, entero-colocutaneous fistula, constitutes unfavorable prognostic sign and enhances the mortality by 62.5%. The presence of UDCT in the patients winh entero-colocutaneous fistula is an aggravating comorbid factor that is difficult to be treated and accompanied by high rates of lethality, which must be taken into account, choosing the adequate surgical tactics and complex pathogenetically substantiated treatment.

Context Scarce data exist regarding the relevance of stimulatory (TSAb) and blocking (TBAb) thyrotropin receptor antibodies in the management of Graves disease (GD). Objective To evaluate the clinical utility and predictive value of TSAb/TBAb. Design Prospective 2-year trial. Setting Academic tertiary referral center. Patients One hundred consecutive, untreated, hyperthyroid GD patients. Methods TSAb was reported as percentage of specimen-to-reference ratio (SRR) (cutoff SRR < 140%). Blocking activity was defined as percent inhibition of luciferase expression relative to induction with bovine thyrotropin (TSH, thyroid stimulating hormone) alone (cutoff > 40% inhibition). Main Outcome Measures Response versus nonresponse to a 24-week methimazole (MMI) treatment defined as biochemical euthyroidism versus persistent hyperthyroidism at week 24 and/or relapse at weeks 36, 48, and 96. Results Forty-four patients responded to MMI, of whom 43% had Graves orbitopathy (GO), while 56 were nonresponders (66% with GO; P < 0.01). At baseline, undiluted serum TSAb but not thyroid binding inhibitory immunoglobulins (TBII) differentiated between thyroidal GD-only versus GD + GO (P < 0.001). Furthermore, at baseline, responders demonstrated marked differences in diluted TSAb titers compared with nonresponders (P < 0.001). During treatment, serum TSAb levels decreased markedly in responders (P < 0.001) but increased in nonresponders (P < 0.01). In contrast, TBII strongly decreased in nonresponders (P = 0.002). All nonresponders and/or those who relapsed during 72-week follow-up period were TSAb-positive at week 24. A shift from TSAb to TBAb was noted in 8 patients during treatment and/or follow-up and led to remission. Conclusions Serum TSAb levels mirror severity of GD. Their increase during MMI treatment is a marker for ongoing disease activity. TSAb dilution analysis had additional predictive value.

Three-dimensional (3-D) high-definition (HD) stereovision and two-dimensional (2-D) ultra-high-resolution (4K) monitors have recently become available for laparoscopic surgery. The aim of this study was to compare laparoscopic performance between inexperienced participants using 3-D/HD and 2-D/4K monitors and those using conventional 2-D/HD monitors.The study enrolled 66 participants with no previous surgical experience or medical training. They were randomly divided into three equal groups, each using a different type of monitor (2-D/HD, 2-D/4K, or 3-D/HD), to perform three phantom tasks using a laparoscopic simulator: Task 1, touching markers on a non-flat surface; Task 2, bimanual peg transfer; and Task 3, passing a straight rod through a loop. Each task was performed three times. The performance scores (operative time, path length of the forceps, and technical errors) were compared for each monitor type and by age group ( 30 vs. 30 years).For all three tasks, scores using the 3-D monitor were significantly better than those using either 2-D monitor, with no difference between the 2-D/4K and 2-D/HD monitors. Using the 2-D monitors, the performance of Task 3 by the participants 30 years was worse than that by the younger participants; however, there was no difference between the age groups when using the 3-D monitor.Participants with no prior experience using a 3-D monitor showed better laparoscopic performance than those using 2-D monitors, even with 4K resolution. This improvement was more marked in older participants, suggesting a greater loss of depth perception in a 2-D environment.

To evaluate the efficacy and safety of the Triple-P procedure as a conservative method in women with morbidly adherent placenta (MAP).A prospective trial conducted on 20 women performing elective cesarean sections (CS) at 37 weeks for anterior placenta previa accreta or increta. All women were young aged with low parity and previous CS deliveries. Triple-P procedure involved delivery of the fetus through a uterine incision placed above the upper border of the placenta, bilateral uterine arteries ligation immediately after delivery of the fetus followed by placental nonseparation and myometrial excision with reconstruction of the uterine wall in a T-shaped manner. The study outcome measures included duration of surgery, amount of intra and postoperative blood loss, Percentage of hemoglobin (Hb %) reduction, the need to perform hysterectomy and postoperative complications.Mean duration of surgery was 58 ± 1.8 min, mean intraoperative blood loss was 1.3 ± 0.3 l, mean postoperative blood loss was 180 ± 94 ml and mean Hb % reduction was 1.5 ± 0.1 g/dl. Only one case necessitated hysterectomy for severe bleeding.Triple-P procedure is a novel effective weapon that can replace hysterectomy in suitable women with MAP, especially in young patients with low parity.