Prospective Nonrandomized Study Research Articles

Intravenous Lidocaine for Refractory Pain in Patients With Pancreatic Ductal Adenocarcinoma and Chronic Pancreatitis: A Multicenter Prospective Nonrandomized Pilot Study.

Refractory pain is a major clinical problem in patients with pancreatic ductal adenocarcinoma (PDAC) and chronic pancreatitis (CP). New, effective therapies to reduce pain are urgently needed. Intravenous lidocaine is used in clinical practice in patients with PDAC and CP, but its efficacy has not been studied prospectively. Multicenter prospective nonrandomized pilot study included patients with moderate or severe pain (Numeric Rating Scale ≥ 4) associated with PDAC or CP in 5 Dutch centers. An intravenous lidocaine bolus of 1.5 mg/kg was followed by continuous infusion at 1.5 mg/kg/hr. The dose was raised every 15 minutes until treatment response (up to a maximum 2 mg/kg/hr) and consecutively administered for 2 hours. Primary outcome was the mean difference in pain severity, preinfusion, and the first day after (Brief Pain Inventory [BPI] scale 1-10). A BPI decrease ≥1.3 points was considered clinically relevant. Overall, 30 patients were included, 19 with PDAC (63%) and 11 with CP (37%). The mean difference in BPI at day 1 was 1.1 (SD ± 1.3) points for patients with PDAC and 0.5 (SD ± 1.7) for patients with CP. A clinically relevant decrease in BPI on day 1 was reported in 9 of 29 patients (31%), and this response lasted up to 1 month. No serious complications were reported, and only 3 minor complications (vertigo, nausea, and tingling of mouth). Treatment with lidocaine did not impact quality of life. Intravenous lidocaine in patients with painful PDAC and CP did not show an overall clinically relevant reduction of pain. However, this pilot study shows that the treatment is feasible in this patient group and had a positive effect in a third of patients which lasted up to a month with only minor side effects. To prove or exclude the efficacy of intravenous lidocaine, the study should be performed in a study with a greater sample size and less heterogeneous patient group.

Original Moxonidine and Generics: Where is the Edge of Difference?

To compare the efficacy of adding original moxonidine and its generics to previous ineffective antihypertensive therapy in patients with poorly controlled arterial hypertension (AH). This observational prospective non-randomized study included 120 patients with poorly controlled blood pressure on the previous antihypertensive therapy. All patients underwent clinical evaluation, including anthropometric and laboratory indexes, and 24-hour blood pressure monitoring (24-h BPM) at baseline and after 12 weeks of observation. Office systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) were recorded after 4 and 12 weeks of treatment. During the observation period, 4 equal groups were formed: group 1, Physiotens was added to the treatment; group 2, Moxonitex; group 3, Moxonidine SZ; and group 4, Moxonidine Canon. Statistical analysis was performed with the StatTech v.4.2.7 software (© OOO StatTech, Russia). After 4 weeks of therapy, the BP target was achieved significantly more frequently in group 1 (63% of patients) compared to groups 2 (36.7% of patients), 3 (16.7% of patients), and 4 (16.7% of patients) (p<0.05). At 12 weeks, office SBP, DBP, and HR were significantly decreased in all groups, but the decrease was significantly greater in group 1. The therapy was associated with a more pronounced decrease in all studied 24-h BPM parameters in the Physiotens group than in other groups, as well as with a significantly more frequent normalization of the 24-h BP profile, in 66.7% of patients vs. 46.7%, 33.4%, and 23.2% of patients in groups 2, 3, and 4, respectively. The treatment with original moxonidine demonstrated advantages over generic drugs in terms of achieving the BP goal, reducing office BP and HR, and improving 24-h BPM parameters.

Efficacy of Self-Expandable Absorbable Stents during Liver Transplant to Minimize Early Biliary Complications.

We analyzed the use of a self-expandable absorbable biliary stent (SEABS) to reduce biliary complications in liver transplant (LT). Complications related to biliary anastomosis are a still a challenge in LT with a high impact on the patient outcomes and hospital costs. This non-randomized prospective study was conducted between July 2019 and September 2023 in adult LT patients with duct-to-duct biliary anastomoses. The primary endpoint was to assess early biliary complications at 90 days in LT patients with intraoperative SEABS versus no SEABS. We also compared overall biliary complications, costs and SEABS- adverse effects related. A total of 158 patients were included, 78 with SEABS and 80 no-SEABS (22 T-tube and 58 no-stent). There were no adverse effects related to SEABS. Early biliary complications (23.8 vs 2.6%, P <0.001) and hospital stay (19 vs 15 days, P= 0.001) were higher in no-SEABS. No-SEABS group required 63 ERCPs and 13 surgeries (including 2 LT) versus 35 ERCPs and 2 surgeries in SEABS group. After PSM between SEABS (n=58) vs no-SEABS (n=58), early biliary complications (40% vs 0%, P<.001) were higher in no-SEABS group. T-tube had more early biliary complications (22.7% vs 5%, P=0.23) compared SEABS high-risk biliary anastomosis. SEABS excess cost per patient was lower compared to T-Tube and no-stent (6.988€ vs 17.992€ vs 36.364€, P=0.036 and P=0.002, respectively). SEABS during biliary anastomosis in LT is feasible with no adverse effects and avoid the T-tube in high-risk biliary anastomoses. It use has been associated with less early biliary complications, hospital costs and reoperations or interventional treatments for biliary complications resolution.

Comparison of Titanium Mesh Cage, Nano-Hydroxyapatite/Polyamide Cage, and 3D-Printed Vertebral Body for Anterior Cervical Corpectomy and Fusion.

A prospective non-randomized controlled study. To compare the clinical and radiographic outcomes of anterior cervical corpectomy and fusion (ACCF) using titanium mesh cages (TMC), nanohydroxyapatite/polyamide66 (n-HA/PA66) cages, and 3D-printed vertebral bodies (3d-VBs). Postoperative subsidence of TMCs in ACCF had been widely reported. Newer implants such as n-HA/PA66 cages and 3d-VBs using biocompatible titanium alloy powder (Ti6Al4V) had been introduced to address this issue, but their outcomes remain controversial. We enrolled 60 patients undergoing ACCF using TMCs, n-HA/PA66 cages, or 3d-VBs from January 2020 to November 2021. For each group, there were 20 patients. Follow-up was conducted for minimum two years. Clinical outcomes, including Japanese Orthopaedic Associationscores (JOA), Neck Disability Index (NDI) and Visual Analogue Scale (VAS) scores and radiographic outcomes, including FSU height, fusion rate, and cervical alignment were collected pre-operatively and at each follow-up. A loss of FSU height equal or greater than 3mm was deemed implant subsidence. One-way analysis of variance was used for comparisons of mean values at different time points within the same group, with pairwise comparisons performed using the LSD method. The Mann-Whitney test was used for comparisons between groups. Categorical data such as gender, smoking status, implant subsidence and pathology level were analyzed using the chi-square test. Postoperative function of spinal unit (FSU) height loss at 2 years differed significantly among the TMC, n-HA/PA66, and 3d-VB groups, measuring 3.07±1.25mm, 2.11±0.73mm, and 1.46±0.71mm, respectively (P<0.001). The rates of implant subsidence were 45%, 20%, and 10%, respectively (P=0.031). All patients obtained solid fusion at 2-year follow-up. We observed statistically significant differences in VAS and JOA scores at 3 months postoperatively, and JOA scores at 2 years postoperatively among the three groups. At two-year follow-up, the n-HA/PA66 and the 3d-VBs groups exhibited less FSU height loss, lower subsidence rates and demonstrated better cervical lordosis than the TMC group. No severe postoperative complications were observed in any of the patients, and no patient required reoperation. At two-year follow-up after ACCF, the n-HA/PA66 and the 3d-VBs groups exhibited less FSU height loss, lower subsidence rates and demonstrated better cervical lordosis than the TMC group. Longer term observation of implant subsidence in ACCF using TMC, n-HA/PA66, and 3d-VB, is necessary. Therapeutic Level III.

Tumor spread through air spaces in lung cancer: prospective analysis of the accuracy of intraoperative frozen section examination.

To establish the accuracy of frozen section examination in identifying tumor spread through air spaces (STAS), as well as to propose a reproducible technical methodology for frozen section analysis. We also aim to propose a method to be incorporated into the decision making about the need for conversion to lobectomy during sublobar resection. This was a nonrandomized prospective study of 38 patients with lung cancer who underwent surgical resection. The findings regarding STAS in the frozen section were compared with the definitive histopathological study of paraffin-embedded sections. We calculated a confusion matrix to obtain the positive predictive value (PPV), negative predictive value (NPV), sensitivity, specificity and accuracy. The intraoperative frozen section analysis identified 7 STAS-positive cases that were also positive in the histopathological examination, as well as 3 STAS-negative cases that were positive in the in the histopathological examination. Therefore, frozen section analysis was determined to have a sensitivity of 70%, specificity of 100%, PPV of 100%, NPV of 90.3%, and accuracy of 92% for identifying STAS. Frozen section analysis is capable of identifying STAS during resection in patients with lung cancer. The PPV, NPV, sensitivity, and specificity showed that the technique proposed could be incorporated at other centers and would allow advances directly linked to prognosis. In addition, given the high accuracy of the technique, it could inform intraoperative decisions regarding sublobar versus lobar resection.

Transforaminal lumbar endoscopic discectomy: should we abandon it for L5-S1 foraminal and extraforaminal lumbar disc herniations? A prospective non-randomised study and literature review

Purpose The aim of this study is to investigate the clinical outcomes of transforaminal lumbar endoscopic discectomy (TLED) in patients with L5-S1 lumbar disc herniation (LDH). Materials and methods Seventy-five consecutive individuals with diagnosed foraminal/extraforaminal L5-S1 LDH were included in this study. All patients underwent TLED, being subsequently evaluated in a 2-year follow-up period. Assessment was performed preoperatively and at 6 weeks and 3, 6, 12 and 24 months postoperatively. Visual Analogue Scale (distinctly applied for lower limb – VAS-LP and low back – VAS-BP pain) and Short-Form 36 (SF-36) Medical Health Survey Questionnaire were implemented to assess pain and health-related quality of life (HRQoL) of enrolled individuals, respectively. Results No major perioperative complications were observed. Recorded values of all studied indices were demonstrated to feature a clinically and statistically significant amelioration at 6 weeks, presenting lesser improvement at 3 months with subsequent stabilisation. VAS-LP and VAS-BP values were displayed to reach a plateau in 6 months postoperatively, whereas all parameters of SF-36 continued to present a statistically significant improvement until the end of follow-up at 2 years. Conclusions TLED represent a safe and efficient technique in terms of diminishing perceived pain and improving HRQoL in patients with L5-S1 LDHs. However, specific patient- and technique-related circumstances on the ground of low surgical experience may limit its effectiveness in these patients.

Introduction and Effectiveness of Early Clinical Exposure Among Dental Students in Pre-clinical Prosthodontics.

Lack of patient contact in the pre-clinical prosthodontics curriculum makes it difficult for the students to comprehend and correlate the series of complex steps involved in complete denture fabrication. Early clinical exposure in the second year of the undergraduate program will facilitate a smooth transition of dental students from pre-clinics to clinics, thereby helping to mitigate the lacunae existing in the present curriculum. A non-randomized prospective educational interventional study was conducted among 50 second-year dental students. Early clinical exposure in the form of clinical demonstration for complete denture steps of border molding and jaw relation was given subsequent to the completion of didactic and laboratory sessions. Pre- and post-multiple-choice question tests were conducted to explore students' knowledge. Student perception towards early clinical exposure was assessed using a self-administered anonymous questionnaire, while faculty perception was gauged with the help of in-depth interviews. A statistically significant difference was observed when pre- and post-multiple-choice question test mean scores were compared, showing an overall improvement in students' knowledge following early clinical exposure. Students and faculty held a positive perception towards the program and found it to be useful in enhancing the overall learning experience of the students.Faculty expressed their concern regarding limited manpower, paucity of time, and difficulty in integrating early clinical exposure into the present timetable. Early clinical exposure can be integrated into the traditional pre-clinical prosthodontics curriculum with appropriate time and manpower allocation. Faculty sensitization and training workshops need to be conducted before implementing this program.

A prospective non-randomized feasibility study of an online membership-based fitness program for promoting physical activity in people with mobility impairments

BackgroundPeople with mobility limitations have a disproportionately higher rate of acquiring secondary conditions such as obesity, cardiovascular comorbidity, pain, fatigue, depression, deconditioning, and type 2 diabetes. These conditions often result from poor access to home and community-based health promotion/wellness programs. The aim of this project was to determine the feasibility of delivering an online community membership-based fitness program for individuals with mobility impairments.MethodsFor this prospective single-arm study, participants were recruited from members of a community fitness facility that serves people with physical disabilities and chronic health conditions. While all members had access to the online platform, individuals had to opt-in to participate in the research component. Activity options included 16 pre-recorded videos and 9 live exercise classes. During the 8-week program, participants had an opportunity to earn three exercise incentives for reaching certain activity milestones. Enrollment percentage, attendance, and attrition were tracked to assess program feasibility and acceptability. Changes in participant-reported outcomes including self-reported physical activity, psychosocial outcomes, and health-related quality of life (HRQOL) were examined using non-parametric analyses.ResultsA total of 146 eligible individuals were screened of which 33 enrolled (22.6%). Two participants withdrew from the study, so a total of 31 were used for analyses. Participants included 29 women and 12 Black people with an average age of 60 (± 15.9) years. Health conditions included stroke, post-polio, arthritis, neuropathy, cerebral palsy, and obesity. Ten participants used an assistive device to get around inside the home. Twenty-six participants (78.8%) completed the online program, and 5 participants earned all 3 participation incentives. The mean number of live Zoom exercise classes attended by the participants was 12.8 (range = 0–43) over 8 weeks; 3 of 31 participants did not attend any classes. On average, participants watched 128 min (range = 0–704 min) of pre-recorded videos; 6 of 31 participants did not view any pre-recorded videos. Self-reported physical activity showed the largest improvement (11.15 units; 95% CI, 3.08, 19.56) with an effect size of 0.51 (Cohen’s d).ConclusionsThis pilot study of an online membership-based fitness program for people with mobility impairments demonstrated preliminary effectiveness in increasing physical activity and was found to be feasible and acceptable. Feasibility endpoints do indicate potential to improve retention. These results suggest that online delivery of exercise programs can broaden the reach of specialized community fitness programs and is a promising direction for future work and fully powered trials are warranted to assess intervention efficacy.Trial registrationClinicalTrials.gov, NCT05138809. Registered September 2, 2021, ClinicalTrials.gov PRS: Record Summary NCT05138809.

Maternal-related factors associated with development and improvement of peripartum cardiomyopathy and therapeutic outcomes of bromocriptine

HIGHLIGHTS Younger age, black race, normotension, and multiparity indicate a poorer prognosis for peripartum cardiomyopathy recovery, while bromocriptine therapy reduces adverse events. ABSTRACT Objectives: This study aimed to fill the significant knowledge gap regarding peripartum cardiomyopathy (PPCM), a heart failure phenotype linked to pregnancy. The main objectives were to explore the factors influencing the development and progression of PPCM and to assess the outcomes of bromocriptine.Materials and Methods: Systematic search across PubMed, ScienceDirect, and Cochrane Library identified studies until December 2022. This study includes non-randomized prospective and retrospective studies, as well as relevant randomized controlled trials. Risk factors were compared between the recovered and non-recovered PPCM groups, and bromocriptine therapy outcomes were evaluated against standard heart failure treatment as the primary endpoint.Results: The analysis included 24 observational studies and 1 randomized controlled trial involving 1,651 PPCM patients; 9 studies evaluating the outcomes of bromocriptine therapy. The most prevalent factors were caesarean delivery (proportion=53%, 95%CI=41%-66%) and anemia (proportion=51%, 95%CI=38%-65%). Non-recovered patients were younger (MD=-1.04 years old, 95%CI=-1.82-(-0.27), p=0.008) and predominantly black (RR=1.82, 95%CI=1.43-2.31, p &lt;0.001). Hypertensive disorders and primiparity were found less among non-recovered patients (RR=0.73, 95%CI=0.60-0.88, p=0.001; RR=0.81, 95%CI=0.66-0.99, p=0.04, respectively). Non-recovered patients also exhibited higher baseline serum creatinine levels, lower LVEF, larger left ventricular end-systolic diameter (LVESD), larger left ventricular end-diastolic diameter (LVEDD), and lower fractional shortening (all P-values&lt;0.05). Furthermore, bromocriptine significantly reduced major adverse cardiac events (MACE), mortality, and increased LVEF (all P-values&lt;0.05).Conclusion: Younger maternal age, black race, absence of hypertension, and multiparity are associated with poorer prognosis for PPCM recovery. Bromocriptine therapy demonstrates superior benefits in reducing adverse events in PPCM.

Progressive Muscle Relaxation Training During Pregnancy: Effects on Mental State, Delivery and Labour Pain - a Prospective Study.

Progressive muscle relaxation is a widely used technique for relaxation, but studies are rare about efficacy on pregnancy and perinatal outcomes. Aim of our study was to determine whether progressive muscle relaxation affects anxiety and depression levels of pregnant women, pregnancy outcomes, labour pain and analgesic requirements. 156 pregnant women were enrolled in a prospective non-randomized controlled cohort study. The control group received standard antenatal care and classes only, while the intervention group additionally received progressive muscle relaxation training once a week for six weeks. Anxiety, depression and current strain were measured in a pretest-posttest experimental design using self-report scales at baseline (1 st survey), 5 weeks later (2 nd survey) and during puerperium (3 rd survey). Numeric Rating scales were used for measuring labour pain and satisfaction with analgesic treatment in the 3 rd survey. Fifty complete questionnaires from each group were analysed. There were no differences in mental status between the groups at baseline. Progressive muscle relaxation training significantly reduced depression levels. Trait anxiety, reflecting a person's basic anxiety decreased significantly in both groups during puerperium. No differences in pregnancy outcomes, labour pain and analgesic requirements could be shown within both groups in general. Nonetheless, women attending more than five progressive muscle relaxation courses reported significantly less labour pain within the group and compared to controls. Pregnant women could benefit from progressive muscle relaxation training if used continuously. Relaxation methods should be a substantial part of prenatal care and available for everyone.

Features of correction of disorders of the digestive system in children with reactive asthenic syndrome

Objective: to study the features of the digestive system in children with reactive asthenic syndrome and correction of disorders using a comprehensive integration program.Materials and methods: a prospective cohort non-randomized study of 419 children of primary school age was conducted. The main group consists of 128 children living in the territory of active hostilities. Control group — 291 children outside the zone of active hostilities. A full examination was carried out before and 6 months after the start of the comprehensive integration rehabilitation program. All children were collected complaints, anamnesis, analysis of outpatient records, objective examination, examination of the motor-evacuation function of the gastrointestinal tract.Results: all children of the main group had complaints from the digestive system. 97 (75.78%) children were concerned about decreased appetite; 79 (61.72%) — stool disorders. Functional disorders were registered in 80 (62.50%) children of the main group, organic pathology — in 62 (48.44%). Among functional abnormalities, functional disorders of the biliary tract were in the first place (in 65 (50.78%) people). Among the organic pathology — diseases of the stomach and 12-duodenum (in 59 (46.09%) children). Peripheral electrogastroenterography revealed in most children of the main group non-impulsive contractions and discoordination of motor skills of varying degrees of severity in all parts of the gastrointestinal tract.Conclusions: the implementation of complex rehabilitation measures optimized the studied indicators with more pronounced effectiveness in children evacuated from active combat zones.

Agreement and repeatability of scotopic pupil size measurement with the 2WIN-S portable refractor in Chinese adults

To assess the agreement and repeatability of scotopic pupil size measurement using 2WIN-S (Adaptica, Padova, Italy) portable refractor in Chinese adults. This prospective non-randomized open-label controlled study assessed the scotopic pupil size of 100 right eyes using OPD-Scan III (Optical path difference) (Nidek Technologies, Gamagori, Japan) and 2WIN-S. OPD-Scan III and 2WIN-S measure pupil size using infrared light and detector, while 2WIN-S measures bilateral eyes simultaneously, OPD-Scan III measures unilateral eyes individually. Participants were first measured once using OPD-Scan III and two consecutive measurements were performed using 2WIN-S after 15 min of rest interval. The primary outcome was to evaluate the agreement between 2WIN-S and OPD-Scan III, and the secondary outcome was to evaluate the repeatability of 2WIN-S. Scotopic pupil size of 100 right eyes of 100 adults (28 male and 72 female) aged 18–53 years (mean 36 ± 12 years) was assessed using OPD-Scan III and 2WIN-S, respectively. The mean scotopic pupil size of OPD-Scan III and 2WIN-S was recorded to be 6.24 ± 0.88 mm and 6.27 ± 0.81 mm, respectively. For the mean scotopic pupil size of OPD-Scan III and 2WIN-S the difference was − 0.03 mm (95%CI − 0.10 to 0.04 mm), p = 0.445, the 95% limits of agreement (LOA) was − 0.71 to 0.66 mm. ICC between the two devices was 0.92 (95% CI 0.88–0.94) (ICC > 0.9 indicates excellent consistency). Coefficients of repeatability (CoR) of 2WIN-S was 0.37, which has a high repeatability. For the mean scotopic pupil size of 2WIN-S of the repeated measurements, the difference was -0.04 mm (95%CI − 0.08 to 0.01 mm), p = 0.019, the 95% limits of agreement (LOA) was − 0.41 to 0.32 mm, with a narrow LOA. However, the majority of the variations were less than ± 0.50 mm (98% of scotopic pupil size measurements were below this threshold), within the clinically acceptable range (± 0.50 mm). Our study showed excellent agreement between 2WIN-S and OPD-Scan III (ICC > 0.9) and a good repeatability of 2WIN-S (CoR = 0.37). This study suggests a novel technique for measuring pupillary responses in low light conditions, which can be considered an alternative to OPD-Scan III in clinical settings.

Cubital vein access provides a practical alternative to internal jugular vein access for coronary sinus catheter placement.

Insertion of electrode catheters into the coronary sinus (CS) through the right internal jugular vein (RIJV) carries risks of pneumothorax and severe hematoma formation. This study was performed to compare the safety and feasibility of catheterization through the left cubital superficial vein versus the RIJV. This prospective nonrandomized study involved consecutive patients who underwent catheter ablation from September 2021 to February 2023. Blind puncture techniques were used in the left cubital vein group; ultrasound-guided insertion was performed in the RIJV group. The success rates of sheath insertion and CS catheterization, the procedure and fluoroscopy times of CS cannulation, and complications were compared between groups. The left cubital vein group comprised 152 patients, and the RIJV group comprised 58 patients. The sheath insertion success rate was significantly lower in the cubital vein group than in the RIJV group (84.9% vs 100%, respectively; p = .0008). In the cubital vein group, blind puncture attempts failed in 20 patients; three patients developed guidewire-induced venous injury. One arterial puncture occurred in the RIJV group. After successful sheath insertion, no significant differences were observed in the CS cannulation success rate (97% vs 100%, p = .55), procedure time (median [range], 93 [51-174] vs 74 [44-129] s; p = .19), or fluoroscopy time (median [range], 66 [36-134] vs 48 [30-92] s; p = .17). No serious complications requiring procedural discontinuation occurred. The left cubital vein approach is practical, offering a viable alternative to the RIJV approach.

P-795 Robust and simple in vitro maturation of ovarian tissue oocytes

Abstract Study question Using in-vitro gametogenesis results in mice, can we perform simple, robust in-vitro maturation (IVM) of oocytes from human ovarian tissue? Summary answer In vitro oogenesis in mice reveals 3 phases of oocyte maturation, IVD, IVG, and IVM. In vivo IVD and IVG simplifes a more robust IVM. What is known already For fertility preservation in cancer patients, IVM of GV’s obtained from ovary tissue with live birth has been achieved, but the results are variable, and great effort has gone into trying to make the “right” culture media, and most are given booster shots of gonadotropin with questionable results. It is easy to obtain many GV oocytes from tiny follicles using open cortical dissection. But it still has remained a puzzle how to do robust IVM in the best way. Study design, size, duration A total of 146 females underwent ovary tissue cryopreservation since 1977. The most recent 38 consecutive such patients between 2 and 38 years of age underwent in-vitro maturation of oocytes (IVM) derived from their ovarian tissue. This is a prospective non-randomized pilot study based upon our results with in vitro oogenesis. Participants/materials, setting, methods After ovarian cortex dissection, the spent media is examined for cumulous complexes (CC’s), which were placed in culture with widely varying concentrations of FSH and HCG, and in a variety of different media. Based on now established mechanisms of in vitro oogenesis, we postulated that the specific media for IVM and the concentrations of HCG would not impact results. There was no prior hormone administration. Main results and the role of chance The harvested germinal vesicle oocyte developed into mature metaphase II oocytes with simple culture media just as well as with “IVM media”, and with HCG concentration from 10 mIU/l to 1000 mIU/l. Of the 38 cases, 18 had had previous chemotherapy or were pre-pubertal. None of these had CC’s. Of the 20 who were post-pubertal and had not yet undergone chemotherapy, the number of CC’s averaged 20 per patient. Of a total of 402 GV oocytes, 137 became mature MII’s (34.1%), varying between 20% and 56%. The only case with low maturation rate (9%) occurred when the cumulus was stripped immediately instead of at 24 hours. Thus mature oocytes can robustly and easily be obtained from ovary tissue with simple media and no need for ovarian stimulation. Furthermore, ovarian stimulation and ovulation are not necessary for oocyte maturation. Oocytes that have just exited IVD that have been exposed to less than 7 days of gonadotropin (IVG) will not mature. Those oocytes exposed to more than 11 days of IVG will degenerate. Thus about 35% of oocytes at any given time will have already been properly prepared in vivo for IVM. Limitations, reasons for caution This is an early proof of concept study in humans with only 30 participants. However, it is completely consistent with what we have predicted from in vitro oogenesis in the mouse. Wider implications of the findings Ovary tissue freezing along with robust IVM will at once provide cancer patients with two possibilities for fertility preservation, without having to delay cancer treatment. Four months of in vivo IVD (non-hormonal) followed by 11 days of IVG (FSH) have already prepared oocytes for IVM. Trial registration number not applicable

Management of Massive Irreparable Posterosuperior Cuff Tears: A Systematic Review for Clinical &amp; Functional &amp; Radiological Outcomes

Abstract Background The management of massive irreparable cuff tears (MIRCT) remains a highly controversial subject with many possible surgical and non-surgical interventions and no clear evidence regarding the most effective and beneficial intervention. Different management options include: conservative management, partial repair, tendon transfer, superior capsular reconstruction, subacromial spacer insertion, reverse total shoulder arthroplasty (RTSA). Aim of the Work The aim of this systematic review is to compare the various methods of management of posterosuperior cuff tears without arthropathy to reach the most effective and sustainable mode of management. Patients and Methods A randomized controlled trial, non-randomized clinical trials, prospective and retrospective comparative cohort studies and case series. We will exclude cross-sectional studies, case reports and literature not in English. Results There is no high quality evidence on management of MIRCT. There was no Level I or II evidence. We included 69 papers that studied different modalities of management of MIRCT, 31 of level III and the remaining were of level IV evidence. Consequently, it’s still difficult to recommend one method of management over the other regarding the management of irreparable cuff tears. Patient age, demands, expectations, thorough clinical examination, surgeon experience and preference are still a major deciding factor when choosing and appropriate method. Conclusion Due to the unavailability of high-quality clinical studies available for guiding management of irreparable MRCT, it is consequently not possible to recommend for or against any specific treatment strategy. Rather, clinical experience, patient factors, patient expectations, and rotator cuff tear characteristics should guide clinical decision-making. Physical therapy compared to surgical treatments may have inferior outcomes. Standardized data collection, reporting and terminology are key to enhancing the quality of evidence-based medicine.

Antiepileptic Drugs as Prophylaxis for Seizures after Excision of Brain Tumors

Abstract Background Seizures are the most common &amp; most serious side effect of cranial surgery. The latter condition requires chronic treatment with Antiepileptic drugs (AEDs) and comes with relevant socioeconomic sequelae. The routine prophylactic use of AEDs for people undergoing tumor resection has remained controversial due to the risk of postoperative seizures. Some Neurosurgeons are advocates to the use of AEDs to reduce the risk of these seizures. Objective To evaluate the efficacy of prophylactic AEDs routinely in brain tumor patients without previous history of seizures. Primary objective has been to identify the efficacy of AEDs in perioperative seizure prophylaxis. Secondary objective has been to highlight the most common type of post-operative AEDs. Methods All available studies from 2000-2021 including randomized or non-randomized clinical trials, prospective or retrospective observational cohort studies, and case series of six or more cases that address these criteria have been collected. Results Our search concluded that the most common type of post-operative seizure is the Early seizure which is of total 87 patients representing 12.3% of seizure reported patients, yet when comparing the P-value between the Early &amp; late seizure it has a P-value of 0.415 which is nonsignificant rendering the comparison redundant. The Most common types of AED used are Phenytoin (PHT) 89 (71.8%) &amp; Levetiracetam (LEV) 109 (81.8%). To measure the efficacy of AEDs two groups of patients with no history of AED administration or seizures preoperatively were created, one the control group of 268 participants were not administered AEDs postoperatively only 32 (11.94%) of them suffered from seizures postoperatively. The other group of 171 participants were administered the AEDs postoperatively only 25 (14.62%) of these participants suffered from postoperative seizure. Comparing both of these results statistically it had a P-value of 0.416 which is non-Significant statistically. On interpreting these results was that the AED have no influence in controlling the seizures. Conclusion Postoperative seizures are one of the main complications of brain tumor surgery. Neurosurgeons have a strong belief more of tradition that preventing seizures with Anti-Epileptic Drugs (AEDs) as a sort of seizure prophylaxis is not only effective but also necessary. Finally, there is not enough evidence of sufficient quality available to suggest that antiepileptic drugs AEDs treatment can or cannot be recommended to reduce Post-craniotomy seizures.

Impact of Knack Manoeuvre Among Women with Urinary Incontinence: A Quasi Experimental Study

ABSTRACT Objective: The Objective of the study is to assess the effectiveness of Knack manoeuvre among women with urinary incontinence. Methods: A quasi-experimental study with a repeated measures design was used to conduct study at Saveetha Medical College Hospital. Experimental group received Knack manoeuvre for 6 months and control group received routine care. The sample size was 100, which was recruited by purposive sampling technique. The data were collected with structured questionnaire, and questionnaire for urinary incontinence diagnosis and biophysiological parameters were assessed by abdominal leak peak pressure (ALPP). Results: The study results depict that frequency and percentage distribution of pretest and post-test level of ALPP. Between group comparison of post-test at 6 months of control and experimental showed significance (P &lt; 0.001). There was a progressive decrease in ALPP of control and experimental groups. Conclusion: To our knowledge, this is the first prospective nonrandomized study that assesses the efficacy of the Knack manoeuvre on urine incontinence by assessing biophysiological parameters.

The Immediate and Delayed Maximal Nonirritating Skin Testing Concentrations of β-Lactam Antibiotics

BackgroundMaximal skin testing (ST) nonirritant concentrations (NICs) are consistent for penicillin and aminopenicillin amongst guidelines. However, there is variability amongst guidelines for maximal ST NICs of cephalosporins. ObjectiveTo determine maximal immediate and delayed ST NICs of 15 β-lactams in β-lactam-tolerant and β-lactam-naïve participants. MethodsWe performed a single-center, nonrandomized prospective study between September 2019 and January 2022 in adult participants. Participants received skin prick testing (SPT) and intradermal test (IDT) injections at six increasing concentrations of 1 or more β-lactams. A concentration was considered irritant when more than 5% of participants had a positive test. A positive test was defined as a wheal ≥3 mm than negative control accompanied by a ≥5 mm flare for SPT/IDT and induration ≥5 mm with associated erythema at 48 hours for delayed readings (dIDT). Sensitivity analyses using 3 alternative IDT positive criteria were conducted. ResultsA total of 747 participants with a median age of 64 (IQR 54-72), 52% males, 85% White, and 92% Non-Hispanic underwent 20,858 skin tests. All undiluted SPT concentrations were nonirritant. We found the following maximal IDT/dIDT NICs (mg/ml): ampicillin (41.6/125), ampicillin-sulbactam (93.8/187.5), aztreonam (6.3/25), cefazolin (55/165), cefepime (35/140), cefoxitin (45/90), ceftaroline (7.5/15), ceftriaxone (58.3/175), cefuroxime (55/110), ertapenem (16.6/50), imipenem-cilastin (6.3/25), meropenem (8.3/25), nafcillin (31.3/62.5), oxacillin (20.9/83.5), and piperacillin-tazobactam (112.5/225). dIDTs were almost all completely non-irritant close or at undiluted concentrations. There were no differences when we applied 3 IDT positivity criteria to our raw data. ConclusionOur results suggest that SPTs with undiluted stock β-lactam antibiotic concentrations are nonirritant. Compared to previously published nonirritant concentrations, we propose a 2 to 50-fold increase to the maximal IDT and dIDT NICs of 15 β-lactam antibiotics. When performing dIDTs, a higher concentration should be used rather than the same IDT concentration.

The Impact of the New Families Home Visiting Program on Depressive Symptoms Among Norwegian Fathers Postpartum: A Nonrandomized Controlled Study.

Becoming a parent is a vulnerable life transition and may affect parents' mental health. Depressive symptoms may occur in fathers, as well as mothers, during pregnancy and the postpartum period. The health service is expected to have a family perspective, aiming to support both parents. Despite this goal, mothers traditionally receive more support than fathers. Home visiting programs may provide enhanced guidance for new fathers and increased mental health support. The aim of this study was therefore to assess possible differences in level of depressive symptom in fathers receiving the New Families home visiting program compared with those receiving standard care from the Norwegian Child Health Service. A prospective nonrandomized controlled study with a parallel group design was performed. The Edinburg Postnatal Depression Scale (EPDS) was used to measure depressive symptoms in fathers (N = 197) at 28 weeks of their partners' pregnancy (T1), at 6 weeks (T2), and 3 months postpartum (T3), in the intervention and the control group. The results indicate a prevalence of depressive symptoms (EPDS score ≥ 10) in Norwegian fathers of 3.1% at T1, 3.9% at T2, and 2.2% at T3 for the full sample. No significant EPDS score differences were found between the intervention and the control group at six weeks and three months postpartum. This suggests that the intervention had no clear impact on depressive symptoms during this time-period.

Wellness and its correlation with vitamin D

Abstract Background: Wellness encompasses various interconnected physical, mental, and social dimensions beyond the traditional definition of health. Vitamin D deficiency is a widespread nutritional deficiency, with a prevalence of 80%–90% in India, and is often under-diagnosed and under-treated worldwide. While vitamin D is classically known for its role in bone health, it also has significant extra-skeletal effects, including maintaining muscle function, immunity, anti-inflammatory activity, and cell proliferation and differentiation. Recent studies have linked vitamin D deficiency to fatigue, myalgia, low-energy fractures, muscle weakness, anxiety, and depression. Furthermore, it is implicated in the development of type 1 and type 2 diabetes mellitus (DM) and hypertension. Vitamin D deficiency is also associated with recurrent exacerbations of bronchial asthma, autoimmune diseases, and malignancies. Addressing this deficiency can substantially enhance patient well-being, prevent serious health outcomes, and improve overall wellness. Aim: This study aims to investigate the relationship between wellness and vitamin D levels. Materials and Methods: This prospective nonrandomized therapeutic study was conducted at MGM Medical College and Hospital, Navi Mumbai, Maharashtra, India, and included 246 participants from July 2021 to December 2022. The study included patients reporting generalized weakness, fatigue, myalgia, low mood, lack of motivation, and decreased interest in life by the inclusion and exclusion criteria. Their serum vitamin D levels were tested. Participants with vitamin D deficiency (&lt;30 ng/mL) completed a pre-structured well-being questionnaire and received vitamin D supplementation for 10 weeks. Wellness in these patients was evaluated using a pre-structured post-supplementation well-being questionnaire. Results: The results revealed that out of 324 patients included in the study, 253 (78.1%) were deficient in vitamin D. The highest deficiency rate was among those aged 18–35 years (85.5%). Vitamin D deficiency was more prevalent in females (79.5%, 167 out of 210 females) compared with males (75.4%, 86 out of 114 males). The paired t test results showed a significant increase in post-test vitamin D levels (t = -219.922, P &lt; 0.001) and a significant decrease in post-test Fatigue Assessment Scores (t = 31.328, P &lt; 0.001) and Fatigue Severity Scores (t = 33.066, P &lt; 0.001). Additionally, there was a significant improvement in post-test World Health Organization-Five Well-Being Index (WHO-5) scores (t = -28.495, P &lt; 0.001) and Warwick–Edinburgh Mental Well-being Scores (WEMWBS; t = -28.996, P &lt; 0.001). Karl Pearson’s correlation coefficient indicated that post-supplementation vitamin D levels were positively correlated with post-supplementation Fatigue Assessment Scores (r = 0.315) and Fatigue Severity Scores (r = 0.334). Conversely, they negatively correlated with the WHO-5 Well-being Index (r = -0.322) and the WEMWBS (r = -0.294). Conclusion: This study concludes that wellness is directly correlated with vitamin D levels. There is a significant improvement in the Fatigue Assessment Scale, Fatigue Severity Scale, WHO-5 Well-being Index, WEMWBS, and overall physical, mental, and social wellness following vitamin D supplementation in patients, both with and without comorbidities (hypertension and DM).