bluuebunny/crossref_metadata_2025_split huggingface dataset:
Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA): NRG-GI008.
Authors: Dasari Arvind , Yu Guan , Kopetz Scott , Puhalla Shannon L. , Lucas Peter C. , Sahin Ibrahim Halil Halil , Deming Dustin A. , Philip Philip A. , Hong Theodore S. , Rojas-Khalil Yesenia , Loree Jonathan M. , Wolmark Norman , Yothers Greg , George Thomas J. , Lieu Christopher Hanyoung 
Published: June 2024

TPS3641 Background: Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer (CC) to determine need for adjuvant chemotherapy (AC). However, circulating tumor DNA (ctDNA) represents a highly specific and sensitive approach (especially with serial monitoring) for identifying minimal/molecular residual disease (MRD) post-surgery in CC patients (pts), and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. CC pts who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may be spared the toxicities associated with AC. Furthermore, for CC pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal AC regimen has not been established. We hypothesize that for pts whose CC has been resected, ctDNA status may be used to risk-stratify for making decisions about AC. Methods: In this prospective phase II/III trial, up to 1,912 pts with resected stage IIB, IIC, and III CC will be enrolled. Based on the post-operative ctDNA status using personalized and tumor-informed assay (Signatera, bespoke assay), those who are ctDNA- (Cohort A) will be randomized to immediate AC with fluoropyrimidine (FP)+oxaliplatin (Ox) for 3-6 mos per established guidelines vserial ctDNA monitoring. Patients who are ctDNA+ post-operatively, or with serial monitoring (Cohort B), will be randomized to FP+Ox v more intensive AC with addition of irinotecan (I) for 6 mos. One cycle of chemotherapy is allowed while awaiting ctDNA testing results for cohort assignment. The primary endpoints for Cohort A are time to ctDNA+ status (phase II) and disease-free survival (DFS) (phase III) in the immediate v delayed AC arms. The primary endpoint for Cohort B is DFS in the FP+Ox v FP+Ox+I arms for both phase II and phase III portions of the trial. Secondary endpoints include prevalence of detectable ctDNA post-operatively, time-to-event outcomes (overall survival and time to recurrence) by ctDNA status, and the assessment of compliance to adjuvant therapy. Biospecimens including archival tumor tissue, as well as post-operative plus serial matched/normal blood samples, will be collected for exploratory correlative research. Active enrollment across the NCTN started in June 2022 with CCTG sites joining in August 2023. Current accrual (as of 02-02-2024) is 240/1,912. NCT05174169. Support: U10-CA-180868, -180822; UG1CA-189867; Natera, Inc. Clinical trial information: NCT05174169 .
Adjuvant chemotherapy with mFOLFOXIRI versus mFOLFOX6 in MRD-positive stage II-III colorectal cancer.
Authors: Zhang Jianwei , Hu Huabin , Cai Yue , Xie Xiaoyu , Wu Zehua , Ling Jiayu , Chen Dianke , Liu Ping , Kang Liang , Deng Yanhong 
Published: June 2024

TPS3642 Background: About 25% to 30% of resectable high-risk stage II and stage III colon cancers might relapse after radical resection and adjuvant chemotherapy with FOLFOX regimen. Recent studies have underscored the significance of circulating tumor DNA (ctDNA)-based minimal residual disease (MRD), representing a residual presence of cancer cells, as a prognostic factor for postoperative recurrence in CRC. Patients exhibiting positive MRD predicted a considerable high risk of recurrence and metastasis, even after adjuvant chemotherapy. In the realm of postoperative adjuvant chemotherapy, Comparing with FOLFOX, whether the early introduction of intensified chemotherapy, mFOLFOXIRI, could further eradicate MRD and improve the long-term prognosis remains unclear. Methods: This multicenter phase III study (NCT05427669) plans to enroll 340 colorectal cancer patients with MRD positive after curative-intent R0 surgical resection, age 18 to 70 years, ECOG performance status 0-1. Patients were randomized (1:1) to receive mFOLFOXIRI (oxaliplatin 85 mg/m², leucovorin 400 mg/m², irinotecan 150 mg/m², and 5-FU 2.4 g/m²over 46 h) or mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², 5-FU bolus 400 mg/m2 then 2.4 g/m² over 46 h) every two weeks for 24 weeks (12 cycles). Patients will be followed for 5 years after the end of adjuvant chemotherapy. The primary endpoint was 3-year DFS. A gain of 14% in 3-yr DFS is expected (74% in the experimental arm vs. 60% in the control arm; α, 5% [two-sided log-rank test]; 1-β, 80%). Secondary endpoints included overall survival, 3-year distant metastasis-free survival, QoL and toxicity. Clinical trial information: NCT05427669 .
The NEO-RT trial: A phase 3 randomized trial of neoadjuvant chemotherapy, excision and observation versus chemoradiotherapy for early rectal cancer, CCTG CO.32.
Authors: Kennecke Hagen Fritz , O'Callaghan Christopher J. , Tu Dongsheng , Leung Roger , Dennis Kristopher , Kachnic Lisa A. , Loree Jonathan M. , Whiteford Mark , Hall William A. , Cohen Stacey A. , Cann Christopher G , VanderWalde Noam Avraham , Nurkin Steven J. , Juul Therese , Cheung Winson Y. , Horowitz David Paul , Locke Gordon , Brown Carl J. 
Published: June 2024

TPS3646 Background: There is significant interest in organ-sparing management of rectal cancer. Data from the National Cancer Database suggest that in 2020 only 20% of US patients with stage I rectal cancer are managed non-operatively. The phase II CCTG CO.28/NEO trial previously reported high rates of tumor downstaging, organ preservation and excellent rectal function among patients with T1-T3abN0 rectal adenocarcinoma treated with 3 months of FOLFOX/CAPOX followed by Transanal Endoscopic Surgery (TES). The phase III CO.32/NEO-RT trial (NCT06205485) will compare two organ sparing strategies for patients with stage I rectal cancer. Methods: Eligible patients with clinical stage T1/2 N0 adenocarcinoma with preserved mismatch repair (MMR) will be randomized 1:1 to ARM A, 3 months of FOLFOX or CAPOX versus ARM B, chemoradiation (54 Gy) followed by tumor restaging within 16 weeks of start of therapy. Patients with histological high grade, mucinous or deficient MMR and those that can be treated with tumor excision alone are excluded. The primary endpoint is tumor downstaging to clinical Complete Response (cCR) by pelvic MRI, endoscopy and digital rectal exam. Subsequent TES is recommended for all patients with tumor response and may be done within 24 weeks of treatment begin, followed by 5 years (y) of observation with serial MRI (q6m x 2y then annually) and endoscopy (q4m x 2y, then q6m during year 3, then annually). The co-primary endpoint is Quality Of Life (QOL) measured by the Low Anterior Resection Score (LARS). In a non-inferiority comparison between treatment arms, if the cCR is assumed to be 45% in ARM B and if there is no true difference between ARMS A and B, then 250 patients are required to be 80% sure that the upper limit of a one-sided 90% confidence interval will exclude a difference in favor of chemoradiation of more than 14%. Results: The approved CCTG CO.32 trial is expected to open February, 2024 at Canadian CCTG and US Alliance, ECOG-ACRIN, NRG, and SWOG NCTN sites with an estimated accrual duration of 4 years. Conclusions: The results of this study will have a major impact on the treatment of patients with stage I rectal cancer. Both arms offer the potential of organ preservation and results will inform whether induction chemotherapy is non-inferior to ChemoRT and compare patient QOL and functional outcomes. Clinical trial information: NCT06205485 .
From the Ordinary to the Everyday
Authors: Laugier Sandra , Cox Hannah 
Published: June 2024

Abstract
This is a new English translation of “De l’ordinaire au quotidien,” originally published in French in 2023. In paragraph 116 of Philosophical Investigations Wittgenstein seems to outline the fundamental goal of his philosophy: “What we do is to bring words back from their metaphysical to their everyday use.” The everyday use to which Wittgenstein constantly refers is far from self-evident: it is just as elusive and indeterminate as our forms of life. The project of Philosophical Investigations is not to replace disqualified logic with the study of use, finding therein a new foundation or new convictions, even purely practical ones. The study of everyday language use presents new problems, arduous in a different way from those of logical analysis, as J. L. Austin and the Oxford School later showed—the same school that, in coining the term Ordinary language philosophy, formalized the Ordinary rather than the Everyday as a central concept. The present article considers several reasons for returning to the concept of the Everyday, Wittgenstein’s point of departure, in the philosophy of language.
Assessment of pain management among nurses using the knowledge and attitude survey regarding pain tool
Authors: Chia Gerk Sin , Wong Yat Yen , Yow Fionna , Ong Wendy YM 
Published: June 2024

Background: The prevalence of pain among cancer patients vary in the cancer trajectory and nurses will encounter patients with cancers who may experience pain. Nurses routinely need to assess and manage pain to deliver quality care. Aim and method: The study aims to understand the knowledge and attitudes of nurses towards pain management using the self-administered questionnaire—the Knowledge and Attitude Survey Regarding Pain (KASRP). Findings: Some 80 nurses participated in the study with an average overall KASRP score of 56%. Areas that were poorly answered are related to the knowledge about opioids, assessment of pain and management of pain in different scenarios. Factors like nurse-patient relationships and being unfamiliar with opioids may affect the knowledge and attitude of nurses towards pain management. Conclusion: Curriculum on pain management needs to consider strategies to help nurses translate knowledge to bedside clinical teaching. It needs to include facts of pain management, and topics regarding self-awareness and clarifying misconceptions.
MINIMALLY INVASIVE SURGERY VERSUS CONSERVATIVE TREATMENT FOR DISPLACED INTRA-ARTICULAR CALCANEAL FRACTURES: A PROSPECTIVE PROPENSITY SCORE-MATCHED COHORT STUDY WITH TWO-YEAR FOLLOW-UP
Authors: Ahluwalia R. , Lewis T. , Musbahi O. , Reichert I. 
Published: June 2024

BackgroundOptimal management of displaced intra-articular calcaneal fractures remains controversial. The aim of this prospective cohort study was to compare the clinical and radiological outcomes of minimally invasive surgery (MIS) versus non-operative treatment in displaced intra-articular calcaneal fracture up to 2-years.MethodsAll displaced intra-articular calcaneal fractures between August 2014 and January 2019 that presented to a level 1 trauma centre were considered for inclusion. The decision to treat was made by a multidisciplinary meeting. Operative treatment protocol involved sinus tarsi approach or percutaneous reduction & internal fixation. Non-operative protocol involved symptomatic management with no attempt at closed reduction. All fractures were classified, and the MOXFQ/EQ-5D-5L scores were used to assess foot and ankle and general health-related quality of life outcomes respectively.Results101 patients were recruited at a level 1 major trauma centre, between August 2014 and January 2019. Our propensity score matched 44 patients in the surgical cohort to 44 patients in the non-surgical cohort. At 24 months, there was no significant difference in the MOXFQ Index score (p<0.05) however the patients in the surgical cohort had a significantly higher EQ-5D-5L Index score (p<0.05). There was also a higher return to work (91% vs 72%, p<0.05) and physical activity rate (46 vs. 35%, p<0.05) in the surgical cohort despite a higher proportion of more complex fractures in the surgical cohort. The wound complication rate following surgery was 16%. 14% of patients in the non-operative cohort subsequently underwent arthrodesis compared to none of the patients in the surgical cohort.ConclusionIn this study, we found operative treatments were associated with low rates of surgical complication at 2-years and long term pain improvement, facilitating earlier and better functional outcomes for complex injury patterns compared to nonoperative treatment.
MEDIAL MALLEOLUS: OPERATIVE OR NONOPERATIVE (MOON). A RANDOMIZED CLINICAL TRIAL OF OPERATIVE VERSUS NONOPERATIVE MANAGEMENT OF ASSOCIATED MEDIAL MALLEOLUS FRACTURES IN UNSTABLE ANKLE FRACTURE DISLOCATIONS
Authors: Carter T. , Oliver W. , Bell K. , Graham C. , Duckworth A.D. , White T. , Heinz N. 
Published: June 2024

IntroductionUnstable ankle fractures are routinely managed operatively. Due to soft-tissue and implant related complications, there has been recent literature reporting on the non-operative management of well-reduced medial malleolus fractures following fibular stabilisation, but with limited evidence supporting routine application. This trial assessed the superiority of internal fixation of well-reduced (displacement ≤2mm) medial malleolus fractures compared with non-fixation following fibular stabilisation.Methods and participantsSuperiority, pragmatic, parallel, prospective randomised clinical trial conducted over a four year period. A total of 154 adult patients with a bi- or trimalleolar fractures were recruited from a single centre. Open injuries and vertical medial malleolar fractures were excluded. Following fibular stabilisation, patients were randomised intra-operatively on a 1:1 basis to fixation or non-fixation after satisfactory fluoroscopic fracture reduction was confirmed. The primary outcome was the Olerud Molander Ankle Score (OMAS) at one-year post-randomisation. Complications and radiographic outcomes were documented over the follow-up period.ResultsAmong 154 participants (mean age, 56.5 years; 119 women [77%]), 144 [94%] completed the trial. At one-year the median OMAS was 80 (IQR, 60–90) in the fixation group compared with 72.5 (IQR, 55–90) in the non-fixation group (p=0.17). Complication rates were comparable. Significantly more patients in the non-fixation group developed a radiographic non-union (20% vs 0%; p<0.001), with the majority (n=8/13) clinically asymptomatic and one patient required surgical re-intervention for this. Fracture type and reduction quality appeared to influence fracture union and patient outcome.ConclusionsIn this randomised clinical trial comparing internal fixation of well-reduced medial malleolus fractures with non-fixation, following fibular stabilisation, fixation was not superior according to the primary outcome. However, 1 in 5 patients following non-fixation developed a radiographic non-union and whilst the re-intervention rate to manage this was low, the future implications require surveillance. These results may support selective non-fixation of anatomically reduced medial malleolus fractures.
A TWO-STAGE APPROACH IN MANAGING DIABETIC FOREFOOT ULCERS
Authors: Sayani J. , Tiruveedhula M. 
Published: June 2024

AimForefoot ulcers in patients with diabetic neuropathy are a result of factors that result in increased forefoot plantar pressures. Progressive hindfoot equinus from contraction of gastrocnemius-soleus-tendo-Achilles complex and progressive plantar flexed metatarsal heads secondary to claw toe deformity results callus at the metatarsal heads which break down to ulceration. The aim is to describe 2-stage treatment pathway for managing these ulcers.MethodsConsecutive patients, who presented with forefoot ulcers since February 2019 were treated with a 2-stage treatment pathway. The first stage of this is an out-patient tendo-Achilles lengthening (TAL). The second stage is surgical proximal dorsal closing wedge metatarsal osteotomy for patients with persistent or recurrent ulcers. Patients were followed for a minimum of 12 months.Results112 patients (146 feet) underwent TAL by 3 consultants. Of these, 96 patients were followed for a minimum of 12 months (range 12–36 months). None had infection or wound related problems at the tenotomy sites; complete transection of the tendon was noted in 4 patients (4%) and one-patient developed heel callosity suggestive of over-lengthening.In 92 patients (96%), the ulcers healed within 10 weeks (± 4 weeks). Additional z-lengthening of peroneal longus and tibialis posterior tendons helped in patients with 1st metatarsal and 5th metatarsal head ulcers respectively. In 12 patients (10%), the ulcer failed to heal or recurred. MRI scan in these patients showed plantar flexed metatarsals from progressive claw toe deformity. The ulcer in this group healed after surgical offloading with proximal dorsal closing wedge osteotomy of the metatarsal/s, with no recurrence at a minimum 12months of follow-up.ConclusionThe described 2-stage treatment pathway results in long-term healing of neuropathic forefoot ulcers, and in 96% of patients, the ulcer healed after the first stage out-patient percutaneous TAL.
CLINICAL, RADIOLOGICAL, AND PATIENT-REPORTED OUTCOMES OF CHARCOT FOOT RECONSTRUCTIVE SURGERY IN A SINGLE CENTRE OVER A FOLLOW-UP PERIOD OF ONE TO SEVEN YEARS
Authors: Martin R. , Sylvester H. , Ramaskandhan J. , Chambers S. , Qasim S. 
Published: June 2024

IntroductionSurgical reconstruction of Charcot joint deformity is increasingly being offered to patients. In our centre a hybrid type fixation technique is utilised: internal and external fixation. This combined fixation has better wound management and earlier mobilisation in this deconditioned patient group. The aim of this study was to assess clinical, radiological and patient reported outcomes for all patients who underwent this hybrid technique.MethodsThis is a prospective observational case series of all patients who underwent surgical reconstruction of Charcot foot deformity in a single centre between June 2017 and June 2023. Patient demographics, smoking status, diabetic control and BMI were recorded. Outcomes were determined from case notes and included clinical outcomes (complications, return to theatre, amputation and mortality) radiological outcomes and patient reported outcomes. The follow up period was 1–7 years post operatively.Results42 reconstructions were included. At the time of surgery the mean age was 59.1 years (29 – 91 years), average HbA1c was 65.2 (33–103); this did not correlate with return to theatre rate. 4 procedures were internal fixation alone (9.5%), 3 external fixation alone (7.1%) and 35 were combined fixation (83.3%). At most recent follow up 7 patients were deceased (16.7%), 2 patients had ipsilateral amputations, 2 had contralateral amputations. 11 patients had issues with recurrent ulcerations. Excluding refreshing of frames and operations on the contralateral side, 17 patients (40%) returned to theatre. We aim to present a detailed analysis of the rate of post-operative complications, return to theatre, radiographic outcomes and patient reported outcomes.ConclusionThis is the largest UK based case series of hybrid type Charcot joint reconstructions and shows that hybrid fixation is a viable option for patients undergoing Charcot joint reconstruction. To best confirm findings and determine which patients have the best post-operative prognosis a larger multi-centre study is required.
SINGLE-STAGE, COMBINED, ORTHO-PLASTICS TREATMENT OF SEVERE CALCANEAL OSTEOMYELITIS WITH LARGE SOFT-TISSUE DEFECTS: LONG-TERM FOLLOW-UP
Authors: Down B. , Tsang S.-T. Jerry , Hotchen A. , Ferguson J. , Stubbs D. , Loizou C. , Ramsden A. , McNally M. , Kendal A. 
Published: June 2024

BackgroundCalcaneal osteomyelitis remains a difficult condition to treat with high rates of recurrence and below knee amputation; particularly in cases of severe soft tissue destruction.AimAssess the outcomes of combined ortho-plastics treatment of complex calcaneal osteomyelitis.MethodA retrospective review was performed of all patients who underwent combined single stage ortho-plastics treatment of calcaneal osteomyelitis (2008–2022). Primary outcome measures were osteomyelitis recurrence and BKA. Secondary outcome measures included flap failure, operative time, complications, length of stay.Results33 patients (16 female, 17 male, mean age = 54.4 years) underwent combined ortho-plastics surgical treatment for BACH “complex” calcaneal osteomyelitis with a median follow-up of 31 months (s.d. 24.3). 20 received a local flap, 13 received a free flap. Fracture-related infection (39%) and diabetic ulceration (33%) were the commonest causes. 54% of patients had already undergone at least one operation elsewhere. There were seven cases of recurrent osteomyelitis (21%); all in the local flap group. One patient required a BKA (3%). Recurrence was associated with increased mortality risk (OR 18.8 (95% CI 1.5–227.8), p=0.004) and reduced likelihood of walking independently (OR 0.14 (95% CI 0.02–0.86), p=0.042).Local flap reconstruction (OR 15 (95% CI 0.8–289.6), p=0.027) and peripheral vascular disease (OR 39.7 (95% CI 1.7–905.6), p=0.006) were associated with increased recurrence risk.Free flap reconstruction took significantly longer intra-operatively than local flaps (443 vs 174 minutes, p<0.001), but without significant differences in length of stay or frequency of out-patient appointments.ConclusionsSingle stage ortho-plastic management was associated with 79% eradication of infection and 3% amputation in this complex and co-morbid patient group. Risk factors for failure were peripheral vascular disease and local flap reconstruction. Whilst good outcomes can be achieved, this treatment requires high levels of in-patient and out-patient care.
WHAT HAPPENS AFTER FAILED TOTAL ANKLE ARTHROPLASTY?
Authors: Jagani N. , Harrison W. , Davenport J. , Karski M. , Ring J. , Smith R. , Clough T. 
Published: June 2024

AimsRetrospective review of a consecutive series of 1,168 total ankle replacements (TAR) performed at Wrightington, to analyse modes of failure and clinical outcomes following TAR failure.MethodsAll patients undergoing TAR between November 1993 – June 2019 were collated (4–25 year follow-up; mean 13.7 years). 6 implants were used (300 STAR, 100 Buechal Pappas, 509 Mobility, 118 Zenith, 41 Salto and 100 Infinity). 5 surgeons, all trained in TAR, performed the surgery. Modes of failure were collated and clinical and radiological outcomes recorded for the revisional surgery following failure of the TAR.Results156 (13.4%) TARs failed (47STAR 15.6%, 16BP 16%, 77Mobility 15.1%, 6Salto 14.6%, 10Zenith 8.5% and 0Infinity 0%). Mean time to failure 5.8 years (0.1- 21.4 years). The 4 most common modes of failure were 44.9% aseptic loosening, 11.5% gutter pain, 10.9% infection and 10.3% recurrent edge loading. 50 underwent conversion to tibiotalocalcaneal (TTC) fusion with nail with 9 (18%) failing to fuse. 31 underwent revision TAR with 2 (6.5%) subsequently failed. 22 underwent ankle fusion with 10 (45%) failing to fuse. 21 underwent polyethylene exchange of which 8 (38%) had further poly failure. 20 (12.8%) were managed conservatively, 2 (1.3%) required below knee amputation and 6 were listed but lost to follow-up. 81 of the 1168 (7%) consecutive cohort were lost to follow-up.Conclusions13.4% of the TAR cohort have failed at average follow-up 13.7 years. There was no difference in failure modes across the implant designs. Whilst the fixed bearing has the shortest follow-up, it may be performing better as there have been no failures so far. Prior to October 2016, most revisions were to fusion (TTC 18% failure rate, ankle 45% failure rate), whereas post 2016, 57% patients elected for revision TAR (6.5% failure).