Thigh Research Articles

Photometric Comparison of Skin Color Match between Abdominal- and Thigh-Based Free Flaps for Breast Reconstruction in Caucasian Patients".

With the increasing demand for autologous breast reconstruction, different surgical techniques have emerged to provide patients with the best possible result tailored to their individual needs. The upper thigh provides an alternative tissue resource in patients where abdominal based flaps are not feasible. While surgical outcomes and donor-site morbidity demonstrate favorable results using abdominal as well as thigh based free flaps for autologous breast reconstruction, the differences in skin constitution and color between the two flap donor-sites have not been investigated. From our flap data base, 60 patients who underwent unilateral secondary breast reconstruction with free DIEP or TMG flaps where randomly selected from our database. In both cohorts, postoperative pictures were used for photometric color evaluation of the reconstructed breast using the Delta E 2000 score at Time A (1.5 - 3 months), Time B (6 - 8 months) and Time C (12 - 20 months). Standard univariate descriptive statistics and group comparisons were performed. The DIEP flap demonstrated a better skin color match at Time A (p < 0.001), Time B (p = 0.003) and Time C (p = 0.009). Over time, both flaps showed improved Delta E 2000 values, and patient age was only associated with higher Delta E 2000 values in TMG flaps after 1.5 - 3 months (p = 0.021). The study provides the first objective analysis of skin color match in secondary autologous breast reconstruction. The DIEP flap reconstruction shows a preferable color match compared to the TMG flap. Both free flaps demonstrate an improved skin color match 12 - 20 months after secondary breast reconstruction.

Liposuction Assisted Medial Thighplasty: An Objective Assessment Using Thigh Circumference

Medial thighplasty is becoming more common among patients who have had massive weight loss (MWL). The excess skin on the inner thigh might create functionality, infection, and mental health difficulties. Popularity notwithstanding, the surgery has a high risk of complications. The purpose of this research was to determine the efficacy and safety of liposuction-assisted medial thighplasty by measuring the effect on thigh circumference in relation to fat aspirate volume and the breadth of the skin that was vertically removed. The Pittsburgh Rating Scale (PRS) was used for patient evaluation. A total of fourteen patients had liposuction-assisted medial thighplasty. Ten patients were categorized as having PRS grade II and four as having PRS grade III, and only those patients were considered for inclusion. The average patient was 48.42 years old, with 12 being female, and their mean body mass index (BMI) was 27.42 kg/m². Among the total complications, wound dehiscence accounted for 35.7% of 50%. Differences in upper (r=0.75, p=0.001) and middle (r=0.77, p=0.001) thigh circumferences were positively correlated with the quantity of lipoaspirate. A weak association was found between variations in upper, middle, and lower thigh circumferences and the breadth of skin that was vertically resected. Patient categorization according to their unique demands is of utmost significance, as is a thorough evaluation of patient wants and needs before medial thighplasty. The overall clinical results are improved by this personalized strategy, which guarantees the best selection of surgical procedures.

Longitudinal associations of diurnal rest-activity rhythms with fatigue, insomnia, and health-related quality of life in survivors of colorectal cancer up to 5 years post-treatment

BackgroundThere is a growing population of survivors of colorectal cancer (CRC). Fatigue and insomnia are common symptoms after CRC, negatively influencing health-related quality of life (HRQoL). Besides increasing physical activity and decreasing sedentary behavior, the timing and patterns of physical activity and rest over the 24-h day (i.e. diurnal rest-activity rhythms) could also play a role in alleviating these symptoms and improving HRQoL. We investigated longitudinal associations of the diurnal rest-activity rhythm (RAR) with fatigue, insomnia, and HRQoL in survivors of CRC.MethodsIn a prospective cohort study among survivors of stage I-III CRC, 5 repeated measurements were performed from 6 weeks up to 5 years post-treatment. Parameters of RAR, including mesor, amplitude, acrophase, circadian quotient, dichotomy index, and 24-h autocorrelation coefficient, were assessed by a custom MATLAB program using data from tri-axial accelerometers worn on the upper thigh for 7 consecutive days. Fatigue, insomnia, and HRQoL were measured by validated questionnaires. Confounder-adjusted linear mixed models were applied to analyze longitudinal associations of RAR with fatigue, insomnia, and HRQoL from 6 weeks until 5 years post-treatment. Additionally, intra-individual and inter-individual associations over time were separated.ResultsData were available from 289 survivors of CRC. All RAR parameters except for 24-h autocorrelation increased from 6 weeks to 6 months post-treatment, after which they remained relatively stable. A higher mesor, amplitude, circadian quotient, dichotomy index, and 24-h autocorrelation were statistically significantly associated with less fatigue and better HRQoL over time. A higher amplitude and circadian quotient were associated with lower insomnia. Most of these associations appeared driven by both within-person changes over time and between-person differences in RAR parameters. No significant associations were observed for acrophase.ConclusionsIn the first five years after CRC treatment, adhering to a generally more active (mesor) and consistent (24-h autocorrelation) RAR, with a pronounced peak activity (amplitude) and a marked difference between daytime and nighttime activity (dichotomy index) was found to be associated with lower fatigue, lower insomnia, and a better HRQoL. Future intervention studies are needed to investigate if restoring RAR among survivors of CRC could help to alleviate symptoms of fatigue and insomnia while enhancing their HRQoL.Trial registrationEnCoRe study NL6904 (https://www.onderzoekmetmensen.nl/).

Ischemic Conditioning Reduces Neuromuscular Fatigability During Dynamic Exercise Post Stroke

INTRODUCTION: In addition to baseline muscle weakness, stroke survivors often demonstrate increased neuromuscular fatigability (an acute exercise-induced reduction in power, hereafter referred to as fatigability), which limits endurance during functional tasks. Ischemic conditioning (IC) is a non-invasive and easy-to-administer intervention that can reduce fatigability in stroke survivors during a sustained isometric contraction of their paretic knee extensors. However, IC’s effects on fatigability during dynamic contractions are unknown, despite the greater relevance to everyday activities. Additionally, fatigability is known to be task specific. Thus, the purpose of this study was to quantify the effects of IC on fatigability (percent reduction in power) during dynamic contractions of the paretic knee extensors in stroke survivors. We hypothesized that fatigability would be less after a single session of IC versus IC-sham treatment in stroke survivors. Methods: Eight stroke survivors (66 ± 6 years of age, 6 male) performed 60 maximal voluntary concentric contractions (1 every 4 seconds) with their paretic knee extensors against a resistance of 30% of their maximal voluntary isometric contraction torque through a 60-degree range of motion after receiving a single session of IC and IC-sham treatment on two separate days. IC consisted of 5 sets of 5-minute upper thigh blood flow occlusion at 225 mmHg (25 mmHg for IC-sham) with 5 minutes of no occlusion between each set. The order of the 2 sessions was randomized. All participants visited the laboratory on a different day for functional measurements (Fugl-Meyer Assessment, 10-meter walk test, and 6-minute walk test). Reduction in power was calculated as the difference between the highest average power output from 5 consecutive contractions within the first 15 contractions and the average power output from the last 5 contractions. A paired t-test was used to compare if fatigability during dynamic exercise would differ between the 2 sessions after IC and IC-sham treatment. Pearson correlation was performed to determine the relationship between the difference in fatigability (after IC versus IC-sham treatment) and functional measurements. Results: After a single session of IC treatment, stroke survivors were less fatigable compared to IC-sham treatment (21.9 ± 19.2% power reduction vs. 29.4 ± 19.0%, p = 0.016). Improvement in fatigability after IC versus IC-sham treatment was positively correlated with Fugl-Meyer Assessment lower extremity motor score ( r = 0.82, p = 0.013). CONCLUSION: These preliminary results indicate that IC could serve as a potential intervention to reduce fatigability during dynamic exercise in stroke survivors, especially those who are mildly affected by stroke. Funding Source: American Heart Association Predoctoral Fellowship (903373, ZZ) and Eunice Kennedy Shriver National Institute of Child Health and Human Development R01 Grant (HD099340, AH &amp; MD). This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

Unexpected focal fluorodeoxyglucose uptake in main organs; pass through or pass by?

Since the inception of fluorine-18 fluorodeoxyglucose (F-18 FDG), positron emission tomography/computed tomography (PET/CT) utilizing F-18 FDG has become widely accepted as a valuable imaging modality in the field of oncology, with global prevalence in clinical practice. Given that a single Torso PET/CT scan encompasses the anatomical region from the skull base to the upper thigh, the detection of incidental abnormal focal hypermetabolism in areas of limited clinical interest is both feasible and not uncommon. Numerous investigations have been undertaken to delineate the distinctive features of these findings, yet the outcomes have proven inconclusive. The incongruent results of these studies present a challenge for physicians, leaving them uncertain about the appropriate course of action. This article provides a succinct overview of the characteristics of fluorodeoxyglucose, followed by a comprehensive discussion of the imaging findings and clinical significance associated with incidental focal abnormal F-18 FDG activity in several representative organs. In conclusion, while the prevalence of unrecognized malignancy varies across organs, malignancies account for a substantial proportion, ranging from approximately one-third to over half, of incidental focal uptake. In light of these rates, physicians are urged to exercise vigilance in not disregarding unexpected uptake, facilitating more assured clinical decisions, and advocating for further active evaluation.

Effects of Ashwagandha ( Withania somnifera) standardized root extract on physical endurance and VO 2max in healthy adults performing resistance training: An eight-week, prospective, randomized, double-blind, placebo-controlled study.

Ashwagandha is a well-known Ayurvedic herb used for youthful vigor and wellbeing. This study investigated the effects of 600 mg standardized root extract (>5% withanolides) of Ashwagandha ( Withania somnifera) on muscle size, strength and cardiorespiratory endurance following resistance training. In this eight-week, parallel-group, multicenter, randomized, double-blind, placebo-controlled clinical study, 80 healthy male and female participants aged 18-45 years, who engaged in regular physical activity were randomly allocated in a 1:1 ratio to receive Ashwagandha (AG, n=40) 300 mg capsules twice daily for eight weeks, or identical placebo (PB, n=40). Seven (3 AG, 4 PB) participants were excluded due to poor compliance. All participants conducted eight-week resistance training. Study outcomes included muscle strength (1RM bench press and leg extension), muscle size(circumference of arm, chest and upper thigh) and cardio-respiratory endurance(VO 2max) assessed at baseline and at eight weeks. Analysis of covariance (ANCOVA) was used to estimate adjusted differences based on sex, BMI and chest circumference at baseline. AG caused greater improvement in bench press (males: p = 0.0084; females: p = 0.0005), leg press (males: p = 0.0049; females: p = 0.018) and endurance (males: p <0.0001; females: p <0.0001) as compared to PB. Also, greater improvements in muscle girth for arm, chest and thigh were seen in both male and female participants with AG. No adverse events were reported in the study. Eight weeks of AG root extract supplementation along with resistance training is effective in improving muscle strength, growth and endurance in both male and female participants. AG root extract could be a safer, effective and low-cost alternative for athletes to improve muscle endurance.

Harvest of large fascia lata autograft: Outcomes in 108 patients.

Due to the reclassification of transvaginal mesh as a high-risk device, there has been renewed interest in the use of fascia lata in pelvic floor reconstruction. Here we report our experience in 108 patients who underwent large fascia lata harvest for pelvic organ prolapse (POP) repair. Our primary objective was to highlight the postoperative morbidity of the large fascia lata harvest in patients who underwent POP repair using fascia lata autograft. Surgery involved harvesting a fascia lata graft through a small lateral upper thigh incision and was used for either autologous transvaginal POP repair or autologous sacrocolpopexy. To prevent seroma, a temporary Jackson-Pratt drain was intraoperatively placed and a mild compression wrap was applied to the area for 4-6 weeks postoperatively. Patient demographics were obtained preoperatively, while physical exam findings and postoperative outcomes related to the fascia lata harvest were collected at sequential follow up visits. One-hundred eight patients underwent 111 large fascia lata harvests for either transvaginal or abdominal/robotic POP repair from July 2016 to January 2022. Mean follow-up was 19.6 months (range: 1-65) with 38 patients having 24 months or more of follow-up. Mean Visual Analog Pain (VAP) score was 1 (range: 0-10). Sixteen patients developed asymptomatic thigh bulges, 16 patients developed harvest site seromas (of which 14 resolved), and 59 patients experienced mild, non-bothersome paresthesia near the incision. Large fascia lata harvest offers a robust autograft for transvaginal or transabdominal POP repair with minimal morbidity. Harvest site complications are minor and typically resolve with expectant management. This technique can be safely utilized in patients who desire graft-augmented repair of POP without the use of synthetic mesh, allograft, or xenograft.

Carcass Characteristics and Meat Quality of Balitbangtan's Superior Village Chickens (KUB) Slaughtered at Different Ages

The research aims to determine the effect of slaughter age on carcass characteristics and meat quality of KUB chickens kept by farmers as meat producers. The research used a completely randomized design with a unidirectional pattern using 65 un-sexed Kampung Unggul Balitbangtan (KUB) chickens. The chickens were divided into 4 slaughter age treatments, namely 4 weeks, 6 weeks, 8 weeks and 10 weeks. At each slaughter age, 15 chickens are used as replications. All chickens in the slaughter age group are slaughtered using the bleeding method in the neck area by cutting off the respiratory tract, blood vessels and digestive tract. After the chicken is declared dead, it is dipped in warm water (temperature 80oC), then the feathers are cleaned, the head and neck, legs are cut and the internal contents are removed. For the purposes of measuring meat quality, meat samples were taken from the chest and then measured at the Animal Products Processing Technology Laboratory, Faculty of Animal Husbandry, Mataram University. Slaughter age increased live weight, lower thigh weight percentage, meat cooking loss value (P&lt;0.01), carcass weight percentage, wing weight percentage, upper thigh weight percentage, and water holding capacity (P&lt;0.05), but did not affect breast weight percentage , back weight and meat pH (P&gt;0.05). It was concluded that delaying the age of slaughter increases the edible part and decreases the inedible part. This research delays the age of slaughter to increase the edible part and reduce the inedible part.

Pharmacokinetics and pharmacodynamics of a pasireotide subcutaneous depot (CAM4071) and comparison with immediate and long-acting release pasireotide.

To assess the pharmacokinetics, pharmacodynamics, safety and tolerability of subcutaneous depot CAM4071, a novel, ready-to-use pasireotide formulation. This was a phase 1, randomised, open-label study in healthy volunteers. After a single 600 µg dose of pasireotide immediate release (IR), participants were randomised to one of eight groups to receive either a CAM4071 upper thigh (5, 10, 20, 40 or 80 mg) or buttock (20 mg) injection or multiple pasireotide IR 900 µg upper thigh injections twice daily or a single pasireotide long-acting release (LAR) 60 mg intramuscular buttock injection. Ninety-four participants were randomised. For all CAM4071 doses, initial pasireotide release was relatively rapid compared to pasireotide LAR and sustained over the 2-month observation period, with a slow decay in plasma concentrations. CAM4071 maximum plasma concentrations increased slightly greater than dose proportionally; area under the curve extrapolated to infinity increased approximately dose proportionally. Relative bioavailability of pasireotide for different doses of CAM4071 versus pasireotide IR 600 μg ranged from 0.752 (90% confidence interval [CI]: 0.58, 0.98) to 1.68 (1.32, 2.14), and versus pasireotide LAR: 0.517 (0.37, 0.72) to 1.15 (0.84, 1.58). CAM4071 doses >5 mg exhibited rapid initial reductions of insulin-like growth factor 1 (IGF-1) compared to pasireotide LAR. Maximum IGF-1 inhibition was greatest for CAM4071 80 mg. CAM4071 injections ≤40 mg were well tolerated and comparable with currently available pasireotide formulations. CAM4071 provided long-acting release of pasireotide over at least one month, with high bioavailability and onset and duration of IGF-1 suppression similar to pasireotide LAR. EudraCT: 2014-003783-20.

Meralgia Paresthetica as a Result of Surgery With an Emphasis on Harvesting Iliac Bone Grafts: A Review.

Meralgia paresthetica is a neurological disorder characterized by a symptom complex of numbness, burning, tingling, aching, or stabbing in the anterolateral portion of the upper thigh. Typically, this disorder is seen in patients with diabetes mellitus, obesity, and pregnancy. Also, it may result from a wide array of surgical interventions involving the region of the anterior superior iliac spine. Underlying pathophysiology concentrates on entrapment neuropathy of the lateral femoral cutaneous nerve (LFCN). Due to its location and wide anatomic variation, the LFCN is susceptible to compression, scarring, and injury during surgery. It is important to understand the regional anatomy. In addition, the plastic surgeon must have a working knowledge of the most common variations that can precipitate entrapment and increase susceptibility to injury during surgery. Surgeons lacking a substantial background on the numerous risk factors, origins, and anatomic variations of the LFCN may place patients at an even higher risk of damage to the nerve. An extensive knowledge of the anatomy and careful technique may be utilized by surgeons to prevent iatrogenic neuropathy of the LFCN.

Oxygen uptake during the last bouts of exercise incorporated into high-intensity intermittent cross-exercise exceeds the [formula omitted] O2max of the same exercise mode

Oxygen uptake (V˙ O2) was measured during a non-exhaustive high-intensity intermittent cross-exercise (HIICE) protocol consisting of four alternating bouts of 20 ​s running (R) and three bouts of bicycle exercise (BE) at ∼160% and ∼170% maximal oxygen uptake (V˙ O2max), respectively, with 10 ​s between-bout rests (sequence R-BE-R-BE-R-BE-R). The V˙ O2 during the last BE ([52.2 ​± ​5.0] mL·kg−1·min−1) was significantly higher than the V˙ O2max of the BE ([48.0 ​± ​5.4] mL·kg−1·min−1, n ​= ​30) and similar to that of running. For clarifying the underlying mechanisms, a corresponding HIICE-protocol with BE and arm cranking ergometer exercise (AC) was used (sequence AC-AC-BE-AC-BE-AC-AC-BE). In some experiments, thigh blood flow was occluded by a cuff around the upper thigh. Without occlusion, the V˙ O2 during the AC ([39.2 ​± ​7.1] mL·kg−1·min−1 [6th bout]) was significantly higher than the V˙ O2max of AC ([30.2 ​± ​4.4] mL·kg−1·min−1, n ​= ​7). With occlusion, the corresponding V˙ O2 ([29.8 ​± ​3.9] mL·kg−1·min−1) was reduced to that of the V˙ O2max of AC and significantly less than the V˙ O2 without occlusion. These findings suggest that during the last bouts of HIICE may exceed the of the specific exercise, probably because it is a summation of the V˙ O2 for the ongoing exercise plus excess post-oxygen consumption (EPOC) produced by the previous exercise with a higher V˙ O2max.

Nephroprotective effect of remote ischemic conditioning on type 2 diabetic rats.

Diabetic nephropathy is one of the main causes of kidney failure in the end stage of diabetes worldwide. The present study was conducted with the aim of using the remote ischemic conditioning (RIC) method to prevent diabetic nephropathy. Diabetes was induced by high-fat diet (60%) and streptozotocin injection (35 mg/kg) in rats. RIC was performed by tightening a tourniquet around the upper thigh and releasing it for three cycles of 5 min of ischemia and 5 min of reperfusion daily for an 8-week duration. At the end of the experiment, serum and urine parameters were examined. Anti-oxidant enzymes and lipid peroxidation levels in the kidney were also determined along with histological examination. The expression levels of tumor necrosis factor-alpha and transforming growth factor beta genes were also evaluated. Glucose, cholesterol, triglyceride, and HbA1c concentrations were not significantly reduced in the RIC group. On the other hand, serum creatinine, urea, and albumin levels decreased and increased in urine. Anti-oxidant enzymes did improve in the kidney significantly and the expression of tumor necrosis factor-alpha and transforming growth factor beta genes decreased significantly. Histopathological examination also showed that necrosis, epithelial damage, and leukocyte infiltration increased in the diabetic group and improved in the treatment group. The results of biochemical analysis, and enzymatic and histological examinations showed that although RIC could not reduce blood glucose and lipids, nevertheless it may delay the progression of diabetic nephropathy due to the presence of anti-inflammatory and anti-oxidant activities.

On the evolution of flow structures around a track cyclist

In this study, flow structures and their evolution over a track cyclist were investigated through wind tunnel tests. In supplement to the experiment, high-fidelity numerical simulations were also conducted to demonstrate the origins of global flow structures. In wind tunnel tests, a full-scale track cyclist mannequin was built based on the three-dimensional scanning of an elite track cyclist in a riding position of a sprint event, and a Cobra probe was used to measure the wake structures. The results show that the preeminent flow structures around the track cyclist mannequin are the streamwise vortices originating from different body parts. The evolution of these vortices involves strong vortex interactions and performs differently on each side, resulting in a dominant streamwise vortex merged behind the right thigh, which is associated with aerodynamic drag productions. In particular, leg position affects the lateral displacement between the elbow vortex and upper thigh, which is the reason for the distinct flow behaviors on each side. This study helps to better understand the flow around a track cyclist, facilitating the development of drag-saving strategies in the future.

Bioabsorbable Temporizing Matrix (BTM): Not Just for Burns.

A skin substitute developed in Australia 2 decades ago for use in acute burns was recently introduced into the United States for the treatment of open wounds. This product has been shown to be very efficacious for coverage of debrided burn wounds. It consists of an inorganic synthetic woven layer that induces cellular ingrowth and deposition of interstitial tissue. It is covered by an attached silicone layer that seals the wound. The product is placed with the woven side directly on the wound. It is fixed in place and optimally covered by a negative pressure dressing for the first 5-10 days. Due to its synthetic composition, it is highly resistant to infection and can stay on the wound for as long as needed. The authors have used this matrix in a wide variety of complex reconstructions in 27 patients, consisting of 10 females and 17 males. Eleven had traumatic wounds of various etiologies (deep burns, crush injuries, Morell-Lavallee lesion, hand injuries, multiple trauma, open fractures, compartment syndromes and soft tissue avulsions). The following wounds were also treated with BTM: pressure ulcers, axillary hidradenitis, scalp wounds, severe facial acne keloidalis, Fournier's gangrene, a diabetic foot ulcer, a chronic venous ulcer, a cutaneous pyoderma gangrenosum, a radiation ulcer with exposed Achilles tendon, a disfiguring scar from an old Dupytrens excision and a non-healing chemotherapy extravasation ulcer. Hand and leg wounds with exposed tendon achieved coverage without tethering. The scalp wounds developed a neodermis and were skin-grafted. A pyoderma gangrenosum patient with excessive slough and uncontrolled bleeding was temporarily immunosuppressed, aggressively debrided and covered with the matrix. Her bleeding resolved. She developed a neodermis, and had reduced symptoms. The Fournier's patient had immediate skin-grafting of his penis and testicles, but the remaining extensive perineal and upper thigh wounds were treated with the matrix and healed without additional skin grafting. A hand patient with a forearm fasciotomy wound was covered with the matrix. As the swelling resolved the size of the defect decreased to the point that the wound was delaminated. The adjacent skin was elevated and used to cover the open area, achieving full closure. There were no complications attributed to the use of the matrix. Several patients healed secondarily with the silicone sheeting gradually peeling off. Seven patients have received or are awaiting skin grafts to be placed over the neodermis. Although this is an early review of the use of this synthetic matrix in the US, it comes with a positive legacy from Australia. The findings thus far indicate that there is a wide range of applications for this product well beyond burn care. Its safety record, resistance to infection and ease of use facilitate surgery.

Ossifying fasciitis: A rare phenomenon and a mimicker for malignancy

Abstract Introduction/Objective Ossifying fasciitis is a relatively rare variant of nodular fasciitis. However, it can mimic malignant lesions, particularly extraosseous osteosarcoma. The purpose of this report is to describe a florid case of ossifying fasciitis with an unusual clinical course in a 17-year-old male. Methods/Case Report A 17-year-old male underwent surgery at an outside hospital for a soft tissue mass in his left upper thigh that had been present for over two years. Pathology was consistent with a benign myofibroblastic tumor. No bone formation was present in the biopsy. Next generation sequencing showed a COL1A1::USP6 gene fusion. The patient was then referred to our institution due to rapid recurrence and unresolving infection at the surgery site. An ultrasound revealed a mass measuring 3.3 x 2.7 x 1.3 cm at the surgery site. The patient subsequently underwent wide surgical resection of the mass.Gross inspection and sectioning of the specimen revealed a well-defined, encapsulated firm calcified lesion with approximately 30% soft pink gelatinous cut surfaces. Microscopically, the lesion was composed of spindle-shaped fibroblastic cells and extensive osteoblastic activity with a zonated transition from immature osteoid to immature woven bone. The diagnosis of ossifying fasciitis was rendered. Results (if a Case Study enter NA) NA Conclusion Rapidly growing lesions can be misinterpreted as sarcomas. Careful microscopic examination and correlation with clinical and radiologic data is critical for accurate diagnosis. Molecular data can be helpful in difficult cases.

Clinical Bridging From Prefilled Syringe to On-body Injector for Risankizumab in Crohn's Disease

This article describes the clinical development bridging strategy and key data to support the marketing application of the risankizumab on-body injection (OBI) system for the treatment of moderately to severely active Crohn's disease (CD), even though the OBI was not evaluated directly in the pivotal Phase III studies in CD. Three studies were conducted as part of the clinical bridging strategy. The pilot pharmacokinetics (PK) study was a Phase I, single-dose, 4-arm, open-label, randomized, parallel-group exploratory PK and tolerability study that assessed the effect of rate and volume of administration on the bioavailability (BA) of risankizumab and the extent of injection site-related pain after subcutaneous (SC) administration in healthy subjects. The pivotal BA/bioequivalence (BE) study was a relative BA/BE bridging study in healthy subjects to assess the relative BA of the to-be-marketed risankizumab OBI compared with the prefilled syringe (PFS) used in the Phase III CD studies. The OBI adhesive study was a randomized, open-label, non-drug interventional study in healthy subjects to assess the OBI adhesive effectiveness and skin tolerability at 2 different locations (abdomen and upper thigh) over different periods of time (5 and 30 minutes). The pilot PK study showed that risankizumab exposures were similar across different rates/volumes of SC administration in healthy subjects, thereby supporting further development of the OBI. Second, a pivotal BA/BE study showed comparability between the OBI and Phase III PFS with bioequivalent risankizumab AUCs and no clinically meaningful difference for Cmax based on the wide therapeutic window of risankizumab. In both studies, no new safety risks were identified. No impact of immunogenicity on PK profile or safety was observed for the OBI. Third, an adhesive OBI (without risankizumab) study showed that there were no differences in adhesion/skin tolerability observed over time (up to 30 minutes) or for location of adhesion, and the OBI device adhesion was well tolerated at both the abdomen and thigh locations. These results supported the risankizumab OBI presentation approval in CD.

Collecting the energy generated by manual workers to monitor their working status and improve their working conditions by using a flexible rack mechanism

Currently, an increasing quantity of portable energy harvesting modules are being developed to capture the energy generated by human motion. However, the size and weight of a device can affect the smoothness and comfort of a user’s normal limb movements in the process of collecting energy generated by human movement. Especially on manual workers, this effect will significantly increase their physical exertion, so the design of energy-harvesting devices for wearing on manual workers has higher requirements. The bend knee energy harvester (BKEH) designed in the work presented in this paper used a laboratory-made flexible rack to harvest the energy generated by manual workers’ frequently bent knees during work. It converts the collected energy into electricity for various wearable devices to monitor the working status of manual workers and improve their working conditions. One end of the flexible rack is fixed to the upper thigh. When the user bends the knee, the flexible rack will move downward, causing the gear to rotate, thereby collecting the energy generated by the body’s movement. The BKEH was made of many lightweight materials and weighed only 406 g, greatly reducing the impact on the user’s normal limb movements and physical exertion. Practical experiments showed that the BKEH output open-circuit voltage is up to 80.3 V, the output power reached as high as 3.16 W, and the power density reached as high as 7.9 W kg−1, which can effectively supply sufficient electrical power for wearable devices to work normally. The BKEH has a high practical value and good adaptability to human movement posture and can generate enough voltage and power to allow some wearable devices to work properly. These wearable devices can effectively provide users with the ability to monitor their work status and improve working conditions.

Association of intraoperative cerebral and somatic tissue oxygen saturation with postoperative acute kidney injury in adult patients undergoing multiple valve surgery

BackgroundThe association between tissue oxygenation with postoperative acute kidney injury (AKI) in adult patients undergoing multiple valve surgery has not been specifically studied.MethodsIn this prospective exploratory cohort study, 99 patients were enrolled. The left forehead, the left forearm, the left upper thigh, and the left renal region tissue oxygen saturation using near-infrared spectroscopy were monitored. The association between each threshold and AKI was assessed. The relative and absolute thresholds were < 70%, < 75%, < 80%, < 85%, < 90%, < 95%, and < 100% baseline, and baseline-standard deviation (SD), -1.5 SD, -2 SD, -2.5 SD, and -3 SD. Multivariate logistic regression analysis was adopted to explore the association.ResultsAKI occurred in 53 (54%) patients. The absolute value-based SrrO2 thresholds associated with AKI were baseline-3 SD (odds ratio [OR], 4.629; 95% confidence interval [CI], 1.238–17.314; P = 0.023) and baseline-2.5 SD (OR, 2.842; 95% CI, 1.025–7.881; P = 0.045) after adjusting for the potential confounders, those are renal region tissue oxygen saturation of 55% and 60%, but not statistically significant after correcting for multiple testing (corrected P = 0.114 and 0.179, respectively).ConclusionThe SrrO2 desaturation, defined as < baseline – 2.5 SD or < baseline – 3 SD, may be associated with AKI. The thresholds need to be verified in future large-scale studies.Trial registrationsThe study was registered at ClinicalTrials.gov, first trial registration: 26/10/2017, identifier: NCT03323203.

Effect of Resistance Training with Blood Flow Restriction on Sitruin-1, Visfatin, and Nitric Oxide Levels in Elite Male Athletes Following Anterior Cruciate Ligament Reconstruction

Background and Aims Blood flow restriction (BFR) training has been suggested as an effective method to improve muscle hypertrophy and for rehabilitation. The present study aims to investigate the effect of resistance training (RT) with BFR on serum levels of sirtuin-1 (SIRT-1), visfatin, and nitric oxide (NO) in elite male athletes after anterior cruciate ligament (ACL) reconstruction. Methods Twenty elite male athletes voluntarily participated in the study and were randomly divided into two groups of RT-BFR (n=10) and RT (n=10). Subjects in both groups participated in 12 weeks of RT at an intensity of 30-70% of 10-repetition maximum (2-4 sets). The subjects in the RT-BFR group performed resistance training by placing a blood pressure cuff in the upper thigh with a pressure of 120-180 mm Hg. Blood samples were collected before and 48 hours after the last training session to measure serum levels of blood markers. Data analysis was done by the analysis of covariance (ANCOVA) and paired t-test. P&lt;0.05 was considered statistically significant. Results Twelve weeks of RT-BFR significantly increased serum levels of SIRT-1 (P&lt;0.001(, visfatin (P=0.02), and NO (P=0.01) in the post-test phase, compared to the pre-test phase. Furthermore, the between-group analysis results showed that RT-BFR significantly increased serum levels of SIRT-1 (P&lt;0.001) and NO (P=0.002) compared to the RT group. Conclusion The RT combined with BFR can increase the serum concentrations of SIRT-1 and NO in elite athletes after ACL reconstruction, compared to the RT alone

Exploring user and stakeholder perspectives from South Africa and Uganda to refine microarray patch development for HIV PrEP delivery and as a multipurpose prevention technology.

Oral HIV pre-exposure prophylaxis (PrEP) is highly effective, but alternative delivery options are needed to reach more users. Microarray patches (MAPs), a novel drug-delivery system containing micron-scale projections or "microneedles" that deliver drugs via skin, are being developed to deliver long-acting HIV PrEP and as a multipurpose prevention technology to protect from HIV and unintended pregnancy. We explored whether MAP technology could meet user and health system needs in two African countries. Researchers in South Africa and Uganda conducted 27 focus group discussions, 76 mock-use exercises, and 31 key informant interviews to explore perceptions about MAPs and specific features such as MAP size, duration of protection, delivery indicator, and health system fit. Participants included young women and men from key populations and vulnerable groups at high risk of HIV and/or unintended pregnancy, including adolescent girls and young women; female sex workers and men who have sex with these women; and men who have sex with men. In Uganda, researchers also recruited young women and men from universities and the community as vulnerable groups. Key stakeholders included health care providers, sexual and reproductive health experts, policymakers, and youth activists. Qualitative data were transcribed, translated, coded, and analyzed to explore perspectives and preferences about MAPs. Survey responses after mock-use in Uganda were tabulated to assess satisfaction with MAP features and highlight areas for additional refinement. All groups expressed interest in MAP technology, reporting perceived advantages over other methods. Most participants preferred the smallest MAP size for ease of use and discreetness. Some would accept a larger MAP if it provided longer protection. Most preferred a protection duration of 1 to 3 months or longer; others preferred 1-week protection. Upper arm and thigh were the most preferred application sites. Up to 30 minutes of wear time was considered acceptable; some wanted longer to ensure the drug was fully delivered. Self-administration was valued by all groups; most preferred initial training by a provider. Potential users and stakeholders showed strong interest in/acceptance of MAP technology, and their feedback identified key improvements for MAP design. If a MAP containing a high-potency antiretroviral or a MAP containing both an antiretroviral and hormonal contraceptive is developed, these products could improve acceptability/uptake of protection options in sub-Saharan Africa.