Percutaneous 60‐Day Peripheral Nerve Stimulation Provides Effective Pain Relief from Occipital Head Pain in the Presence of Migraine: Results from a Prospective, Single‐Arm, Multicenter Pilot Study
Abstract Fields, JB, Jones, MT, Kitts, SE, King, EL, and Jagim, AR. Relationships between disordered eating, body dissatisfaction, and low energy availability in women collegiate athletes. J Strength Cond Res 40(2): e164–e171, 2026—Women collegiate student-athletes face unique challenges regarding nutrition, body image, and athletic performance, increasing their risk for low energy availability (LEA), disordered eating (DE), and body dissatisfaction (BID). However, limited data exist exploring LEA, DE, and BID across a variety of women's sports. Therefore, the purpose of this study was to evaluate the prevalence of and relationships among LEA risk, DE behaviors, and BID in women collegiate athletes from multiple sports. Division I, II, and III women student-athletes ( n = 115) participated in this cross-sectional, descriptive study. Athletes completed the low energy availability for females questionnaire (LEAF-Q), eating attitudes test (EAT-26), muscularity-oriented eating test (MOET), and body dissatisfaction items from the eating disorder examination questionnaire (EDE-Q) to assess LEA risk, DE behaviors, and BID, respectively. Sixty-four percentages of athletes were at risk for LEA, with the highest prevalence in volleyball (100%), wrestling (68%), lacrosse (67%), and cross country (57%). However, only 8% of athletes were classified at risk for eating disorders. Notably, 81 and 84% of athletes reported body weight and shape dissatisfaction, respectively, which was strongly associated with disordered eating behaviors (EAT-26: r = 0.707; MOET: r = 0.723, p < 0.001). These results show a high prevalence of LEA risk and BID across athletes, with DE behaviors strongly linked to body image concerns. Despite a high LEA risk among athletes, clinical eating disorder risk remained low, suggesting that undereating may often be unintentional. Targeted interventions focused on nutritional education, body image, and psychological support are critical for improving health and performance outcomes among collegiate women student-athletes.
Comparison of Open, Laparoscopic, and Robotic Approaches for Hartmann’s Reversal: The Mayo Clinic Experience
BACKGROUND: End colostomy reversal with colorectal anastomosis (Hartmann’s reversal) is a technically challenging procedure associated with significant morbidity due to adhesions and distorted anatomy after the index surgery. OBJECTIVE: To compare perioperative outcomes of open, laparoscopic, and robotic approaches for Hartmann’s reversal. DESIGN: Retrospective analysis of prospectively maintained data. SETTINGS: High-volume tertiary referral center with specialized colorectal surgery expertise. PATIENTS: A total of 218 patients who underwent Hartmann’s reversal between May 2018 and April 2023. MAIN OUTCOME MEASURES: Primary outcomes included hospital length of stay and rate of conversion. Secondary outcomes included overall complication rates and time to return of bowel function. RESULTS: Of 218 patients, 139 (63.8%) underwent open surgery, 48 (22.0%) underwent laparoscopic surgery, and 31 (14.2%) underwent robotic surgery. Robotic surgery had the lowest estimated blood loss (median 77.5 vs 100 mL laparoscopic and 150 mL open, p < 0.0001). Conversion to open surgery occurred in 16.1% of robotic cases compared with 35.4% of laparoscopic cases ( p = 0.0618). Minimally invasive approaches were associated with shorter hospital length of stay (median 3.0 vs 4.0 days, p < 0.0001) and faster return of bowel function (median 2.0 vs 3.0 days, p = 0.0095) compared to open surgery. Overall 30-day morbidity was 23.4%, with no significant difference among approaches ( p = 0.30). The temporal trend showed increasing adoption of robotic techniques, from 0% in 2018 to 53.8% in 2023, and a decrease in the proportion of cases approached by open surgery, from 76.9% in 2018 to 23.1% in 2023. LIMITATIONS: Retrospective design and single-institution experience with limited follow-up duration. CONCLUSIONS: Minimally invasive approaches to Hartmann’s reversal are associated with improved short-term outcomes compared to open surgery. The robotic approach shows promise in reducing conversion rates, potentially extending the benefits of minimally invasive surgery to more patients undergoing this challenging procedure. See Video Abstract . COMPARACIÓN DE LOS ENFOQUES ABIERTO, LAPAROSCÓPICO Y ROBÓTICO PARA LA REVERSIÓN DE HARTMANN: LA EXPERIENCIA DE LA CLÍNICA MAYO ANTECEDENTES: La reversión de la colostomía terminal con anastomosis colorrectal (reversión de Hartmann) es un procedimiento técnicamente complejo asociado a una morbilidad significativa debido a las adherencias y la distorsión anatómica tras la cirugía inicial. OBJETIVO: Comparar los resultados perioperatorios de los abordajes abiertos, laparoscópicos y robóticos para la reversión de Hartmann. DISEÑO: Análisis retrospectivo de datos mantenidos prospectivamente. ENTORNO: Centro terciario de referencia de gran volumen con experiencia especializada en cirugía colorrectal. PACIENTES: Un total de 218 se sometieron a la reversión de Hartmann entre mayo de 2018 y abril de 2023. PRINCIPALES MEDIDAS DE RESULTADOS: Los resultados primarios incluyeron la duración de la estancia hospitalaria y la tasa de conversión. Los resultados secundarios incluyeron las tasas generales de complicaciones y el tiempo de recuperación de la función intestinal. RESULTADOS: De los 218 pacientes, 139 (63,8 %) se sometieron a cirugía abierta, 48 (22,0 %) a cirugía laparoscópica y 31 (14,2 %) a cirugía robótica. La cirugía robótica tuvo la menor pérdida de sangre estimada (mediana, 77,5 ml frente a 100 ml en laparoscopia y 150 ml en cirugía abierta, p < 0,0001). La conversión a cirugía abierta se produjo en el 16,1 % de los casos robóticos frente al 35,4 % de los casos laparoscópicos ( p = 0,0618). Los abordajes mínimamente invasivos se asociaron con una estancia hospitalaria más corta (mediana de 3,0 días frente a 4,0 días, p < 0,0001) y un retorno más rápido de la función intestinal (mediana de 2,0 días frente a 3,0 días, p = 0,0095) en comparación con la cirugía abierta. La morbilidad global a los 30 días fue del 23,4 %, sin diferencias significativas entre los distintos enfoques ( p = 0,30). La tendencia temporal mostró un aumento en la adopción de técnicas robóticas, del 0 % en 2018 al 53,8 % en 2023, y una disminución en la proporción de casos abordados mediante cirugía abierta, del 76,9 % en 2018 al 23,1 % en 2023. LIMITACIONES: Diseño retrospectivo y experiencia de una sola institución con una duración de seguimiento limitada. CONCLUSIONES: Los enfoques mínimamente invasivos para la reversión de Hartmann se asocian con mejores resultados a corto plazo en comparación con la cirugía abierta. El enfoque robótico es prometedor para reducir las tasas de conversión, lo que podría ampliar los beneficios de la cirugía mínimamente invasiva a más pacientes que se someten a este procedimiento tan complejo. ( AI-generated translation ).
Diagnostic Performance and Interpreter Experience of 1-Hour Versus 3-Hour
99m
Tc-HMDP Cardiac Amyloid Radionuclide Imaging: A Prospective, Blinded Comparison
BACKGROUND: Guidelines recommend 3-hour cardiac amyloid radionuclide imaging (CARI) for transthyretin amyloid cardiomyopathy. Citing rapid blood clearance of 99m Tc-hydroxymethylene-diphosphonate (HMDP) and efficient laboratory throughput, 1-hour imaging is increasingly practiced despite limited supporting evidence. We sought to compare diagnostic performance and interpreter experience of 1-hour versus 3-hour HMDP-CARI. METHODS: Consecutive patients with suspected transthyretin amyloid cardiomyopathy (n=114) underwent both 1-hour and 3-hour HMDP single photon emission computed tomography (CT)/CT. Two cardiologist-radiologist reader teams, blinded to imaging timepoint (1 versus 3 hours), assessed overall interpretation, single photon emission CT–based Perugini grade, interpretation difficulty, interpreter confidence, and need for CT-fused images for anatomic localization. Discordant, equivocal, and difficult cases were arbitrated by a third tie-breaking team. The myocardial-to-blood-pool radiotracer uptake ratio (3-dimensional Score) was measured as a surrogate of contrast resolution. RESULTS: Interinterpreter agreement was high at both time points (κ≥0.81), with more cases requiring arbitration at 3 hours versus 1 hour (22% versus 13%; P =0.049). Overall interpretation and Perugini grades were concordant between time points in 111/114 (97%) and 106/114 (93%) patients, respectively. Three patients (3%) were negative at 1 hour but equivocal at 3 hours, all of which were clinically ruled out for transthyretin amyloid cardiomyopathy. Interpreter confidence was comparable at both timepoints (97% versus 95%; P =0.317). Compared with 3-hour imaging, contrast resolution was inferior (lower 3-dimensional score, P <0.001) and CT fusion was more frequently needed (57% versus 31%, P <0.001) at 1-hour imaging. CONCLUSIONS: In a prospective, blinded comparison of 1-hour versus 3-hour HMDP-CARI, diagnostic performance and interpreter experience were similar, with readers requesting CT fusion more frequently at 1 hour to optimize myocardial-to-blood pool discrimination.
Septic Arthritis Secondary to Acupuncture in an Immunocompromised Patient With Multiple Comorbid Conditions
ABSTRACT Background Previous studies on the relationship between prediabetes, HbA1c and cognitive trajectories show mixed results. Therefore, we investigated the association of prediabetes, diabetes and HbA1c with change in global and domain‐specific cognitive scores in cognitively unimpaired (CU) adults, as well as the potential effect modification by sex or age. Methods This longitudinal study included 4236 CU persons aged ≥ 50 years from the population‐based Mayo Clinic Study of Aging. We ran linear mixed‐effect models with baseline prediabetes, diabetes and HbA1c predicting longitudinal global and domain‐specific (i.e., memory, language, attention/executive function, and visuospatial skills) cognitive z‐scores and raw scores. Models were adjusted for age, sex, education, medical comorbidity, repeated cognitive testing, and ApoEɛ4. We additionally ran models with sex and age interactions. Results Compared to normoglycemic individuals, individuals with prediabetes and diabetes showed poorer performance on cognitive tests, i.e., TMT‐B, category fluency, and block design subtest over time. Additionally, the presence of prediabetes, diabetes, longer diabetes duration and higher HbA1c were associated with faster global and domain‐specific cognitive decline over a median follow‐up of 6.4 years (range 1–19). Three‐way interactions showed that the effect of diabetes on decline in global cognition, attention and visuospatial domains was more pronounced in women than in men. Age did not modify the effect of diabetes or higher HbA1c on cognition. Conclusions The results suggest that prediabetes and diabetes significantly shorten the timeframe before a potentially clinically noticeable change in global and domain‐specific cognition is reached. Thus, lifestyle modification to reverse prediabetes and prevent diabetes could potentially reduce the rate of cognitive decline in aging populations. The findings differed by sex (i.e., the effect of diabetes on decline in global cognition, attention and visuospatial domains was more pronounced in women than men).
POEMS syndrome: diagnosis, treatments, and outcomes
Abstract POEMS (polyneuropathy, organomegaly, endocrinopathy, M protein, skin changes) syndrome is a complex paraneoplastic syndrome related to a lambda-restricted low–tumor burden neoplasm. The diagnosis must be considered in the context of what might otherwise be believed to be a “monoclonal gammopathy of undetermined significance,” with unusual features including, but not limited to, peripheral neuropathy, thrombocytosis, and extracellular volume overload. Once a diagnosis of POEMS syndrome is made, besides very specific supportive care, the treatments resemble those of multiple myeloma or solitary plasmacytoma of the bone. Based on case series, autologous stem cell transplant is still a favored therapy with durable remissions even without maintenance therapy. Even before the era of therapeutic monoclonal antibodies, bispecific T-cell engagers, and chimeric antigen receptor antibodies, 10-year overall survival approached 80%. Patients achieving a complete hematologic response have a progression-free survival of 88% even without maintenance therapy. Herein, a case of a patient with a less-than-average outcome is described to highlight some of the long-term challenges and complexities of managing patients with POEMS syndrome.
Abstract JAK2 unmutated/wild-type erythrocytosis is a prevalent condition encompassing a wide spectrum of hereditary and acquired entities. It is conventionally defined by the same hemoglobin/hematocrit thresholds as for polycythemia vera. Incidence has been reported to be between 0.13% and 4.1%. The most clinically relevant step in the workup of erythrocytosis is the exclusion of polycythemia vera through JAK2 mutation screening. Consideration of relative polycythemia, normal outliers, and the influence of erythropoietic drugs and comorbidities is also imperative. Distinguishing long-standing from newly acquired erythrocytosis further streamlines the diagnostic process. Hereditary erythrocytosis (HE) is lifelong and typically associated with a positive family history. Subnormal serum erythropoietin (EPO) suggests an EPO receptor mutation. Otherwise, oxygen tension at 50% hemoglobin saturation (p50) discerns between high oxygen-affinity hemoglobin variants, 3-bisphosphoglycerate deficiency, methemoglobinemia, and PIEZO1 mutations (low p50) and germline oxygen-sensing pathway/other rare mutations (normal p50). Acquired erythrocytosis results from hypoxia-driven factors (eg, cardiopulmonary, altitude, renal artery stenosis) and other mechanisms of EPO overproduction (eg, EPO-secreting tumors) or hypersensitivity, as well as EPO-independent mechanisms. Drugs (eg, sodium glucose co-transporter-2 inhibitors, testosterone) are also common causes. Idiopathic erythrocytosis is a diagnosis of exclusion, increasingly attributed to underlying genetic mutations/polymorphisms. There are currently no evidence-based treatment guidelines. Low-dose aspirin and/or phlebotomy (with frequency determined by symptom relief) might be considered on an individualized basis in the presence of hyperviscosity symptoms, cardiovascular comorbidities, and/or a history of thrombosis. Aggressive control of cardiovascular risk factors is recommended in all. A graphic abstract representation is provided in Figure 1.
ReInspire: A phase 2 study of mutant-selective PI3Kα inhibitor, RLY-2608, in adults and children with PIK3CA-related overgrowth spectrum and malformations driven by PIK3CA mutation
Abstract Background and Significance Somatic gain-of-function mutations in the PIK3CA gene can result in a range of vascular malformations (VMs). These rare disorders include lymphatic anomalies and PIK3CA-related overgrowth spectrum (PROS). VMs are noncancerous lesions that may be managed with treatments such as surgery, sclerotherapy, sirolimus, and non-mutant-selective PI3Kα inhibitors; however, use of systemic therapies in patients is frequently limited by drug-related adverse effects. In particular, inhibition of wild-type PI3Kα results in significant toxicity, including hyperglycemia, diarrhea and rash. RLY-2608 is a novel, allosteric, pan-mutant and isoform-selective oral PI3Kα inhibitor designed to have higher potency and improved tolerability. In a PIK3CAH1047R HUVEC xenograft mouse model, RLY-2608 demonstrated greater lesion regression and less insulin induction across clinically relevant dose levels than alpelisib (Llambi, VAC 2025). ReInspire (RLY-2608-201; NCT06789913) is an ongoing, global, multicenter study in patients with PIK3CA-driven VMs to assess the safety, pharmacokinetics, recommended adult and pediatric dosing, and efficacy of RLY-2608 based on target lesion volume and clinical outcome assessments. The design of this study, including dose selection, was informed by clinical data from the first-in-human study of RLY-2608 in adult patients with advanced solid tumors, including breast cancer (Varkaris et al, 2024). Study Design and Methods ReInspire is a 3-part study evaluating the safety and efficacy of RLY-2608 in approximately 277 patients two years of age and older with PIK3CA-driven VMs and PROS. RLY-2608 is administered orally in continuous cycles. The primary endpoints are safety, tolerability, recommended Phase 2 dose (RP2D), and efficacy of RLY-2608 per volumetric reduction on MRI (≥20% reduction from baseline to Week 24 in the sum of target lesion volumes) by blinded independent central review. Other endpoints include duration of response and change in age-appropriate clinical outcome assessments. Patients are enrolled in a staggered fashion by age, beginning with adult and adolescent participants 12 years and older (Group 1), and may be extended to pediatric participants 6 to <12 years (Group 2) and 2 to <6 years, based on review of cumulative clinical data. Part 1 is the open-label dose-finding portion, which initiates with randomization of Group 1 patients (n=45) to one of three dose levels with stratification according to prior alpelisib use, and will be followed by weight-based dose escalation using a Bayesian optimal interval (BOIN) design in Groups 2 and 3, if opened. Part 2 is a basket-style, open-label dose expansion that will evaluate the clinical activity of RLY-2608 at one or more RP2Ds in various populations in cohorts of 20 patients each based on Part 1 findings. Depending on the results of Parts 1 and 2, Part 3, a double-blinded, placebo-controlled, 2:1 randomized study (n=90), may be opened to patients 6 years of age and older. To enroll, patients are required to have a clinical diagnosis of PROS or a malformation within the ISSVA classifications, and the majority must have a documented activating PIK3CA mutation per local assessment of lesional tissue and/or cell-free DNA from the lesion or blood. Patients with other known pathogenic somatic or germline driver mutations (such as TIE2 (TEK) and AKT1) are not eligible. Patients must be a candidate for investigational systemic therapy; have severe, symptomatic, and/or progressive disease; and at least one target lesion amenable for volumetric assessment. Additionally, patients who have received disease-directed therapy must undergo a washout period for systemic treatment and local therapies including radiation, surgery and other procedures. Patients with Type 1 or 2 diabetes requiring antihyperglycemic medication or fasting plasma glucose ≥140 mg/dL, or glycosylated hemoglobin (HbA1c) ≥7.0% (≥53 mmol/mol) are not eligible. Statistical analyses will be primarily descriptive in nature in Parts 1 and 2, with statistical comparisons between RLY-2608 and placebo at Week 24. ReInspire is open to enrollment. Patients ≥12 years are now enrolling in Part 1. For more information, contact clinicaltrials@relaytx.com
Outcomes from the Multicenter ACCRU-LY-1804/CARiBOU (Cytarabine, Acalabrutinib and Rituximab integrated with Bortezomib-based Outpatient therapy) Trial in 1st line Mantle Cell Lymphoma
Abstract Introduction: First-line therapy for mantle cell lymphoma (MCL) represents a critical opportunity for clinical benefit via sustained complete response. Multitargeted combinations, including optimized chemotherapy with novel agents targeted to MCL, may best address the biologic heterogeneity of this disease. Building on prior experience using modified VR-CAP and R-cytarabine, we enhanced this regimen by adding acalabrutinib while reducing cytarabine, aiming for improved efficacy and safety without impeding stem cell collection. To evaluate this regimen, we conducted a phase 2 multicenter trial at four centers in the Academic and Community Cancer Research United (ACCRU) network. Methods: CARiBOU (ACCRU-LY-1804) employs alternating VR-CAP and R-cytarabine with continuous acalabrutinib, in six 21-day cycles, for previously untreated MCL. Eligible patients (pts) were at least 18 years old with adequate organ function, measurable disease, no CNS involvement; and were ASCT-eligible per investigator. VR-CAP (cycles 1, 3, and 5) employed bortezomib 1.3 mg/m² subcutaneously days 1,8, and 15; rituximab 375 mg/m² day 1; cyclophosphamide 750 mg/m² day 1; doxorubicin 50 mg/m2 day 1; and prednisone 100 mg PO days 1-5. Cycles 2,4, and 6 used outpatient rituximab with cytarabine at 3 g/m² x 2 daily doses in the first 5 pts, after which the dose was reduced to 2 gm/m2 x 2 daily doses due to thrombocytopenia. Acalabrutinib 100 mg p.o. twice daily was given continuously but held for grade 4 thrombocytopenia or clinically significant toxicity. Growth factors and prophylactic antimicrobials were required. Responses were assessed after six cycles using FDG PET/CT, bone marrow aspirate/biopsy (BM Bx), and endoscopy when indicated (Lugano 2014). The primary endpoint was complete metabolic response (CMR) rate at end of treatment (EOT). Secondary endpoints included safety, feasibility of stem cell collection, proportion proceeding to ASCT, and progression-free (PFS) and overall survival (OS). Peripheral blood measurable residual disease (MRD) was evaluated using the ClonoSEQ assay (Adaptive Biotechnologies). A Simon two-stage design was used, targeting a CMR rate ≥ 70% versus a null rate of 50%, with a total sample size of 39 evaluable pts. Results: 41 pts were accrued from October 2021 through May 2025, 37 of whom completed all 6 cycles and are evaluable for response; two are still on therapy, and two discontinued therapy early for toxicity. Median age was 63 years (range 41-73), 22% were female, and 85% were White. MIPI risk groups were low (44%), intermediate (39%), and high (17%), and Ki-67 was ≥ 30% in 54% of pts. Three pts (7%) had known TP53 mutations by sequencing. At EOT, the CMR rate was 85.3% among all pts (35/41; 95% CI 67.9%-92.9%), or 94.5% among evaluable pts (35/37). BM Bx was performed in 31 pts at EOT, 30 of which (96.8%) were negative for MCL. Undetectable peripheral blood MRD using a 10^6 threshold (uMRD6) was achieved at EOT in 78.1% (25/32) of tested pts, and 93.8% (30/32) achieved uMRD5. Nine of 41 pts underwent ASCT; no patient failed stem cell collection. Maintenance therapy was not protocol-defined but included rituximab in 91.9% of pts and a BTK inhibitor in 21.6% of pts. With a median follow-up of 16.7 months, PFS and OS rates at 18 months were 76.7% (95% CI: 60.7%-96.9%) and 95.5% (95% CI: 87.1%-100%). Toxicities were primarily hematologic. Grade 3+ toxicities included thrombocytopenia (66.6%), neutropenia (28.2%), and anemia (25.6%). Grade 3+ febrile neutropenia was observed in 10.2% of pts. Peripheral neuropathy was seen in 20.5% of pts and all grade 1-2. Bleeding events included purpura in 2 pts (5.2%) and epistaxis in 1 patient (2.6%). One case of atrial fibrillation was observed. Eighteen pts required temporary dose hold of acalabrutinib for toxicity (mainly thrombocytopenia), and 2 had acalabrutinib dose reductions. Serious adverse events occurred in 6 pts, and no treatment-related deaths occurred. Conclusions: CARiBOU is an efficient, highly effective outpatient regimen for 1st line MCL, employing intermediate dose cytarabine with continuous acalabrutinib. With supportive care and platelet monitoring, this approach safely yielded high rates of CMR and uMRD6, supporting multitargeted induction therapy for appropriate pts with untreated MCL.