bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase II basket trial of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART) SWOG S1609: the desmoid tumors
Authors: Chae Young Kwang , Othus Megan , Patel Sandip , Powers Benjamin , Hsueh Chung-Tsen , Govindarajan Rangaswamy , Bucur Silvana , Kim Hye Sung , Chung Liam IL-Young , McLeod Christine , Chen Helen X , Sharon Elad , Streicher Howard , Ryan Christopher W , Blanke Charles , Kurzrock Razelle 
Published: September 2024

BackgroundDual inhibition using anti-programmed death-1 (PD-1) and anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) checkpoint inhibitors has proven effective in many cancers. However, its efficacy in rare solid cancers remains unclear. Desmoid tumors are ultrarare soft-tissue tumors, traditionally treated with surgery. This study reviews the first results of using ipilimumab and nivolumab in the desmoid tumor cohort of the SWOG S1609 Dual Anti-CTLA-4 & Anti-PD-1 blockade in Rare Tumors (DART) trial.MethodsDART is a prospective/open-label/multicenter (1,016 US sites)/multicohort phase II trial of ipilimumab (1 mg/kg intravenously every 6 weeks) plus nivolumab (240 mg intravenously every 2 weeks) that opened at 1,016 US sites. The primary endpoint included overall response rate (ORR) defined as confirmed complete (CR) and partial responses (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. Secondary endpoints include progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR; stable disease (SD) ≥6 months plus CR and PR) and toxicity.ResultsSixteen evaluable patients (median age: 37) with desmoid tumors and a median of 1.5 prior therapies (with no prior exposure to immunotherapy) were analyzed. The tumors varied in location (eight abdomen, three lower limb, two upper limb, two pelvis, and one neck). ORR was 18.8% (3/16; 3 confirmed PR): 40% regression (PFS 30+ months), 83% regression (PFS 16 months) and 71% regression (PFS 8.4 months). Seven additional patients (43.8%) had prolonged SD over 6 months (PFS: 16.5, 22.4+, 22.6, 30.1, 38.2+, 48.3+ and 60.7+ months). Overall CBR was 62.5% (10/16). Median PFS was 19.4 months, with 6-month PFS of 73% and 1-year PFS of 67%. All patients were alive at 1 year; median OS was not assessable, as 13 patients were alive at analysis. Common adverse events included fatigue, nausea and hypothyroidism, with 50% experiencing grade 3–4 events. There were no grade 5 events.ConclusionTreatment with ipilimumab and nivolumab in desmoid tumors yielded an ORR of 18.8% and a CBR of 62.5% with durable responses seen. This is the first prospective study exploring the efficacy of this combination in this rare disease. Ongoing studies aim to identify markers for response and resistance. Expanded trials are necessary.Trial registration numberNCT02834013.
A multicenter, randomized, non-comparative, phase II study of nivolumab ± ipilimumab for patients with metastatic sarcoma (Alliance A091401): expansion cohorts and correlative analyses
Authors: Seligson Nathan D , Chen James L , Goodrich Austin C , Van Tine Brian A , Campbell Jordan D , Richards Allison L , Antonescu Cristina R , Liebner David A , Milhem Mohammed M , Streicher Howard , Tap William D , Schwartz Gary K , George Suzanne , D'Angelo Sandra P 
Published: September 2024

BackgroundIn this open-label, randomized, non-comparative, multicenter phase II study (Alliance A091401) we report on three expansion cohorts treated with nivolumab (N) with and without ipilimumab (N+I) and provide a multi-omic correlative analysis of actionable biomarkers.MethodsPatients were randomized (non-comparative) to receive either N or N+I. The primary endpoint was a 6-month confirmed response rate (CRR) defined by Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints included treatment-related adverse events (TRAEs), progression-free survival, and overall survival. Multi-omic correlative analyses were conducted using samples from both the primary and expansion cohorts.ResultsA total of 66 patients were evaluated for the primary endpoint with disease including gastrointestinal stromal tumor (GIST, n=18), undifferentiated pleomorphic sarcoma (UPS, n=24), and dedifferentiated liposarcoma (DDLPS, n=24). Neither N nor N+I achieved a complete or partial response in the GIST expansion cohort. In DDLPS and UPS, the primary response endpoint of CRR was met with N+I (both 16.6%, 2/12) but not with N alone (both 8.3%, 1/12). In the GIST cohort, TRAE was higher with N+I treatment, halting enrollment as required per protocol. In a correlative analysis of patients for the expansion cohort and the original cohort (n=86), traditional biomarkers of immunotherapy response were not correlated with response in any histological subtype. Markers of genomic instability including the presence of gene fusions and increased subclonal mutations correlated with improved clinical outcomes.ConclusionsThis expansion cohort reaffirms the outcomes of A091401. There remains a pressing need to determine the role of and predictive biomarkers for immunotherapy in sarcoma.Trial registration numberNCT02500797.
On difficulties to define prognostic factors for clinical practice in rheumatoid arthritis
Authors: Vittecoq Olivier , Brevet Pauline , Gerard Baptiste , Lequerre Thierry 
Published: September 2024

In rheumatoid arthritis (RA), the identification of prognostic factors (PF) capable of predicting disease outcome, response to treatment or success of dose reduction is an important issue, as these factors are intended to serve as a basis for decision-making. The task is complex from the outset, as the definition of disease prognosis or therapeutic prognosis is not uniquevocal. The heterogeneity of the definitions used partly explains the failure to identify PF that can be applied at an individual level. But other factors also contribute. First, the scope of the disease studied is too broad, including nosologically different entities. Second, potential PF are only measured at a single point of time, whereas changes over a period of time should be taken into account to a greater extent, not forgetting the potential impact of the treatment received during this period. Beyond these limiting factors, one of the main obstacles to the identification of PF is probably the fact that the phase of the disease is not sufficiently taken into account. Predicting the disease outcome when it is well established is a more complex challenge than when it is just beginning, as many factors are likely to interfere. The same applies to therapeutic PF, which should be determined according to disease duration. Difficulties also arise from the approaches used, which are often restricted to a single field of interest whereas they should be much more integrative and call on new large-scale data analysis tools with a view to precision medicine.In RA, prognosis can be defined at two levels: disease outcome, including joint damage and risk of extra-articular manifestations and/or complications, and treatment outcome, including response to therapy, risk of adverse effects and drug-free remission.
Resuscitative endovascular balloon occlusion of the aorta (REBOA) for non-trauma patients in an urban hospital: a series of two cases
Authors: van de Voort Jan C , Vrancken Suzanne M , Manusama Eric R , Borger van der Burg Boudewijn L S , Klinkert Pieter , Hoencamp Rigo 
Published: September 2024

BackgroundResuscitative endovascular balloon occlusion of the aorta (REBOA) is increasingly being used for temporary bleeding control in patients with trauma with non-compressible truncal hemorrhage (NCTH). In recent years, the technique is gaining popularity in postpartum hemorrhage and non-traumatic cardiac arrest, although still underutilized. In other surgical fields, however, there is not yet much awareness for the possible advantages of this technique. Consequently, for non-trauma indications, limited data are available.MethodsDescription of the use of REBOA in two patients with hemorrhagic shock due to exsanguinating non-traumatic NCTH.ResultsIn the first case, REBOA was deployed at the emergency department in a patient in their 80s presenting with hemorrhagic shock due to a ruptured abdominal aortic aneurysm. Hemodynamic stability was obtained and a CT scan was subsequently performed for planning of endovascular aneurysm repair. After successful placement of the endograft, the REBOA catheter was deflated and removed. In the second case, REBOA was performed in a patient with shock due to iatrogenic epigastric artery bleeding after an umbilical hernia repair to prevent hemodynamic collapse and facilitate induction of anesthesia for definitive surgery. During laparotomy, blood pressure-guided intermittent aortic balloon occlusion was used to preserve perfusion of the abdominal organs. Patient made a full recovery.ConclusionREBOA deployment was successful in achieving temporary hemorrhage control and hemodynamic stability in patients with non-traumatic NCTH. REBOA facilitated diagnostic work-up, transportation to the operating room and prevented hemodynamic collapse during definitive surgical repair. In the right patient and skilled hands, this relatively simple endovascular procedure could buy precious time and prove lifesaving in a variety of non-compressible hemorrhage.
Implementation of a novel daily performance improvement checklist (PIC) improves alcohol screening and intervention compliance in trauma
Authors: Jeffery Michelle , Toussaint Ashley , Choron Rachel L , Englert Zachary P , Piplani Charoo , Murphy Timothy , Falcon Lisa A , Narayan Mayur , Teichman Amanda L 
Published: September 2024

IntroductionScreening, brief intervention, and referral to treatment (SBIRT) has demonstrated up to 50% reduction in alcohol-related traumatic injury and is mandated by the American College of Surgeons for trauma center accreditation. While SBIRT effectiveness has been previously investigated, optimal implementation in the trauma setting has not. We sought to improve SBIRT compliance through integration of screening into a performance improvement checklist (PIC) deployed during morning report. We hypothesized that PIC would establish a self-sustaining model for improved alcohol screening/intervention.MethodsThis was a retrospective study comparing trauma patients pre-PIC (January–May 2022) to post-PIC (January–May 2023) after PIC implementation in January 2023. The primary outcome was SBIRT performance. The PIC prompted alcohol intervention specialist consultation if blood alcohol content >80 mg/dL, <21 years old, or Alcohol Use Disorders Identification Test ≥8. Significance was determined if p<0.05.ResultsThere were 705 pre-PIC and 840 post-PIC patients. Pre-PIC unscreened patients were more often uninsured (13% vs. 25%, p<0.01) and black (8% vs. 14%, p=0.02) compared with screened pre-PIC patients. There were no significant differences among screened versus unscreened patients after PIC with respect to age, sex, race, or ethnicity (p>0.05). Overall, screening improved pre-PIC to post-PIC (52% vs. 88%, p<0.01) and the percentage of patients who screened positively also increased after PIC (8% vs. 23%, p<0.01). Brief intervention was unchanged (83% vs. 81%, p=1).ConclusionThe PIC is a novel tool that demonstrated improved alcohol screening and referral. It improved compliance with SBIRT and reduced implicit bias in the population screened. Utilization of a PIC is easily translatable to other centers and could become a national standard to advance performance improvement.Level of evidenceIV.
Use of an Integrated Pulmonary Index pathway decreased unplanned ICU admissions in elderly patients with rib fractures
Authors: Davis Nicholas , Lindbloom Peter , Hromatka Kathleen , Gipson Jonathan , West Michaela A 
Published: September 2024

Unplanned intensive care unit (ICU) admission (UIA) is a Trauma Quality Improvement Program benchmark that is associated with increased morbidity, mortality, and length of stay (LOS). Elderly patients with multiple rib fractures are at increased risk of respiratory failure. The Integrated Pulmonary Index (IPI) assesses respiratory compromise by incorporating SpO2, respiratory rate, pulse, and end-tidal CO2to yield an integer between 1 and 10 (worst and best). We hypothesized that IPI monitoring would decrease UIA for respiratory failure in elderly trauma patients with rib fractures.MethodsElderly (≥65 years old) trauma inpatients admitted to a level 1 trauma center from February 2020 to February 2023 were retrospectively studied during the introduction of IPI monitoring on the trauma floor. Patients with ≥4 rib fractures (or ≥2 with history of chronic obstructive pulmonary disease) were eligible for IPI monitoring and were compared with a group of chest Abbreviated Injury Scale score of 3 (≥3 rib fractures) patients who received usual care. Nurses contacted the surgeon for IPI ≤7. Patient intervention was left to the discretion of the provider. The primary endpoint was UIA for respiratory failure. Secondary endpoints were overall UIA, mortality, and LOS. Statistical analysis was performed using χ2test and Student’s t-test, with p<0.05 considered significant.ResultsA total of 110 patients received IPI monitoring and were compared with 207 patients who did not. The IPI cohort was comparable to the non-IPI cohort in terms of gender, Injury Severity Score, Abbreviated Injury Scale, mortality, and LOS. There were 16 UIAs in the non-IPI cohort and two in the IPI cohort (p=0.039). There were no UIAs for respiratory failure in the IPI group compared with nine in the non-IPI group (p=0.03).ConclusionIPI monitoring is an easy-to-set up tool with minimal risk and was associated with a significant decrease in UIA in elderly patients with rib fracture.Level of evidenceLevel III, therapeutic/care management.
Efficacy and Safety of Finerenone Across the Ejection Fraction Spectrum in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Analysis of the FINEARTS-HF Trial
Authors: Docherty Kieran F. , Henderson Alasdair D. , Jhund Pardeep S. , Claggett Brian L. , Desai Akshay S. , Mueller Katharina , Viswanathan Prabhakar , Scalise Andrea , Lam Carolyn S.P. , Senni Michele , Shah Sanjiv J. , Voors Adriaan A. , Zannad Faiez , Pitt Bertram , Vaduganathan Muthiah , Solomon Scott D. , McMurray John J.V. 
Published: September 2024

BACKGROUND:
The effects of treatments for heart failure (HF) may vary among patients according to left ventricular ejection fraction (LVEF). In FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure), the nonsteroidal mineralocorticoid receptor antagonist finerenone reduced the risk of cardiovascular death and total worsening HF events in patients with HF with mildly reduced or preserved ejection fraction. We examined the effect of finerenone according to LVEF in FINEARTS-HF.

METHODS:
FINEARTS-HF was a randomized, placebo-controlled trial examining the efficacy and safety of finerenone in patients with HF and LVEF ≥40%. The treatment effect of finerenone was examined in prespecified analyses according to LVEF categories (<50%, ≥50% to <60%, and ≥60%) and with LVEF as a continuous variable. The primary outcome was a composite of total (first and recurrent) worsening HF events and cardiovascular death.

RESULTS:

Baseline LVEF data were available for 5993 of the 6001 participants in FINEARTS-HF. Mean and median LVEF were 53±8% and 53% (interquartile range, 46%–58%), respectively. LVEF was <50% in 2172 (36%), between 50% and <60% in 2674 (45%), and ≥60% in 1147 (19%). Patients with higher LVEF were older, were more commonly female, were less likely to have a history of coronary artery disease, and more frequently had a history of hypertension and chronic kidney disease compared with those with a lower LVEF. Finerenone reduced the risk of cardiovascular death and total HF events consistently across LVEF categories (LVEF <50% rate ratio, 0.84 [95% CI, 0.68–1.03]; LVEF ≥50% to <60% rate ratio, 0.80 [0.66–0.97]; and LVEF ≥60% rate ratio, 0.94 [0.70–1.25];
P
interaction
=0.70). There was no modification of the benefit of finerenone across the range of LVEF when analyzed as a continuous variable (
P
interaction
=0.28). There was a similar consistent effect of finerenone on reducing the total number of worsening HF events (continuous
P
interaction
=0.26).

CONCLUSIONS:
In patients with HF with mildly reduced or preserved ejection fraction, finerenone reduced the risk of cardiovascular death and worsening HF events, irrespective of LVEF.

REGISTRATION:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT04435626. URL:
https://eudract.ema.europa.eu
; Unique identifier: 2020-000306-29.
Tail Bounds on the Runtime of Categorical Compact Genetic Algorithm
Authors: Hamano Ryoki , Uchida Kento , Shirakawa Shinichi , Morinaga Daiki , Akimoto Youhei 
Published: October 2024

Abstract
The majority of theoretical analyses of evolutionary algorithms in the discrete domain focus on binary optimization algorithms, even though black-box optimization on the categorical domain has many practical applications. In this paper, we consider a probabilistic model-based algorithm using the family of categorical distributions as its underlying distribution and set the sample size as two. We term this specific algorithm the categorical compact genetic algorithm (ccGA). The ccGA can be considered as an extension of the compact genetic algorithm (cGA), which is an efficient binary optimization algorithm. We theoretically analyze the dependency of the number of possible categories K, the number of dimensions D, and the learning rate η on the runtime. We investigate the tail bound of the runtime on two typical linear functions on the categorical domain: categorical OneMax (COM) and KVal. We derive that the runtimes on COM and KVal are O(Dln(DK)/η) and Θ(DlnK/η) with high probability, respectively. Our analysis is a generalization for that of the cGA on the binary domain.
Physical Intimate Partner Violence and Increased Partner Aggression During Pregnancy During the COVID-19 Pandemic: Results From the Pregnancy Risk Assessment Monitoring System
Authors: D’Angelo Denise V. , Kapaya Martha , Swedo Elizabeth A. , Basile Kathleen C. , Agathis Nickolas T. , Zapata Lauren B. , Lee Rosalyn D. , Li Qing , Ruvalcaba Yanet , Meeker Jessica R. , Salvesen von Essen Beatriz , Clayton Heather B. , Warner Lee 
Published: September 2024

Objectives: Public health emergencies can elevate the risk for intimate partner violence (IPV). Our objectives were 2-fold: first, to assess the prevalence of physical IPV and increased aggression from a husband or partner that occurred during pregnancy and was perceived to be due to the COVID-19 pandemic; second, to examine associations between these experiences and (1) COVID-19–related stressors and (2) postpartum outcomes. Methods: We used data from the Pregnancy Risk Assessment Monitoring System that were collected in 29 US jurisdictions among individuals with a live birth in 2020. We estimated the prevalence of violence during pregnancy by demographic characteristics and COVID-19–related stressors. We calculated adjusted prevalence ratios (APRs) to examine associations of physical IPV or increased aggression with COVID-19–related stressors, postpartum outcomes, and infant birth outcomes. Results: Among 14 154 respondents, 1.6% reported physical IPV during pregnancy, and 3.1% reported increased aggression by a husband or partner due to the COVID-19 pandemic. Respondents experiencing any economic, housing, or childcare COVID-19–related stressors reported approximately twice the prevalence of both types of violence as compared with those without COVID-19–related stressors. Physical IPV and increased aggression were associated with a higher prevalence of postpartum depressive symptoms (APRs, 1.73 and 2.28, respectively) and postpartum cigarette smoking (APRs, 1.74 and 2.19). Physical IPV was associated with a lower prevalence of attending postpartum care visits (APR, 1.84). Conclusions: Our findings support the need for ongoing efforts to prevent IPV during pregnancy and to ensure the availability of resources during public health emergencies.
Increased Identification of Vaccines for Vaccine Safety Surveillance Through Linkage With the Minnesota Immunization Information Connection as of December 31, 2023
Authors: Zhu Jingyi , Vazquez-Benitez Gabriela , DeSilva Malini B. , Kuckler Leslie , Trower Nicole , Muscoplat Miriam Halstead , Bieringer Aaron , Groom Holly C. , Kharbanda Elyse O. 
Published: September 2024

Objectives: The HealthPartners’ Vaccine Safety Datalink (VSD) team maintains standardized files of vaccines from medical and pharmacy claims and electronic health records (established data sources) for safety surveillance. Since 2021, for selected vaccines, data from the Minnesota Immunization Information Connection (MIIC), Minnesota’s immunization information system, have been added to the HealthPartners’ VSD files. We examined how MIIC data have enhanced the identification of novel and routine vaccines. Methods: We describe the approach to incorporating MIIC data. We determined and compared the number and proportion of vaccines identified from established data sources with the additional capture of vaccine data identified from MIIC, in which age group and period of observation varied by vaccine. Results: As of December 31, 2023, of 1 099 411 people in the HealthPartners’ VSD cohort, 1 001 400 people (91%) were linked with an MIIC record. Across all data sources, for the full cohort, >2.7 million COVID-19 vaccine doses were recorded since 2020, >4000 mpox vaccine doses since 2022, >7.3 million influenza vaccine doses since 2004, >600 000 human papillomavirus (HPV) vaccine doses since 2006, and >1.1 million diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine doses since 2004. For COVID-19 vaccines, about 30% of vaccine doses were exclusively captured from MIIC, with the remaining 70% from established data sources. For the mpox vaccine, about 42% were exclusively from MIIC. For influenza, HPV, and DTaP vaccines, about 20%, 14%, and 17%, respectively, were exclusively identified from MIIC. Conclusions: Incorporation of data from state immunization information systems into existing vaccine data files can enhance monitoring on the safety of novel vaccines administered outside traditional health care settings and can enhance data quality for routine childhood and adult vaccines.
A Cross-Sectional Study of Concurrent Validity of the “Indian Disability Evaluation and Assessment Scale” with the “Sheehan Disability Scale” in Patients with Common Mental Disorders
Authors: Kondapura Manjunatha B , Manjunatha Narayana , Nagaraj Anil Kumar M , Praharaj Samir K , Kumar Channaveerachari Naveen , Math Suresh Bada 
Published: October 2024

Background: Worldwide, common mental disorders (CMDs) (depression, anxiety, somatoform disorders) have a high prevalence in the community. About one-third of them experience disability. As the Indian Disability Evaluation and Assessment Scale (IDEAS) was originally designed by the Indian Psychiatric Society to assess disability in severe mental illnesses, it has not been widely used among CMDs. Our objective was to compare and establish a correlation between the level of disability obtained using IDEAS and the Sheehan Disability Scale (SDS) in CMDs. Methods: A cross-sectional assessment of disability was performed among 220 consenting patients with CMDs. Disability scores of IDEAS and SDS were compared and correlated across the three varieties of CMDs. Results: Age, gender, education, socioeconomic class, duration of illness, and duration of treatment exhibited significant differences among the three CMD groups. Both IDEAS and SDS show a milder level of disability; they did not differ significantly in their scores across CMDs. A strong correlation was seen between SDS and IDEAS across most domains. Conclusion: The study revealed strong concurrent validity between the two scales, thus advocating that indigenously designed IDEAS can convincingly assess disability across the CMDs among the Indian population.