tbuckley/cabot-search huggingface dataset:
Effect of limited reporting in clinical trials on the ability to guide treatment decisions for real-world patients with cancer.
Authors: Ene Mercy Enogela, Risha Gidwani, Jeffrey Franks, Nicole E. Caston, Gabrielle Betty Rocque
Journal: Journal of Clinical Oncology (2021)

18 Background: National Comprehensive Cancer Network (NCCN) guidelines are derived from reviews of clinical trials. Many of these trials have strict inclusion criteria, resulting in trial samples that are not representative of the larger cancer population. We therefore sought to understand how clinical trials, referenced in the NCCN guidelines, report key patient baseline demographics relating to age, race/ethnicity, and country or geographic region. Methods: NCCN guidelines for four cancer types were reviewed: prostate, colon, breast, and lung. We abstracted race/ethnicity, age, country/geographic region, and hazard ratios (HRs) from references indexed in the NCCN Guidelines. Race/ethnicity and age information was obtained from baseline characteristics tables in reported studies. The country/geographic region from which participants were recruited was acquired from each individual trial’s National Clinical Trial (NCT) number, linked to clinicaltrial.gov or the main manuscript. Each study was also assessed for its reporting of survival outcomes based on race/ethnicity, age, and country. Results: A total of 31 studies reporting on 36 regimens were examined for this review. While all studies reported age, only 39% (n=12) included characterization of older adults (60 years or older). 52% provided information on the racial and ethnic makeup of the study sample. Countries where participants were recruited were mostly not reported in the main papers, rather they were identified from ClinicalTrials.gov. Also, while 67% of all studies (n=25) included an international sample, only 5% reported the country or geographic location in the main manuscript. Few studies reported efficacy by patient sub-population. 12 of the 31 (39%) manuscripts reported HRs by age. Of the 16 manuscripts reporting race/ethnicity, 16% included HRs by race/ethnicity. Only one study reported efficacy outcomes by country. Conclusions: There is a need to have a standardized system for reporting baseline characteristics as well as trial outcomes for clinical trials. Including information on subgroup-specific baseline and efficacy outcomes in clinical trial results is an inexpensive way of improving the quality of information available to oncologists and will aid them in making evidence-based treatment decisions for the entirety of their patient populations.
Multiethnic genome-wide and HLA association study of total serum IgE level
Authors: Michelle Daya, Corey Cox, Nathalie Acevedo, Meher P. Boorgula, Monica Campbell, Sameer Chavan, Michael H. Cho, Gloria L. David, Priyadarshini Kachroo, Jessica Lasky-Su, Xingnan Li, Caitlin P. McHugh, Dandi Qiao, Nicholas Rafaels, Lisa A. Beck, Eugene R. Bleecker, Luis Caraballo, Adrienne L. Cupples, Camila A. Figueiredo, Richard L. Gallo, Jon Hanifin, Nadia N. Hansel, Tissa R. Hata, Craig P. Hersh, Jennifer Knight-Madden, Donald Y.M. Leung, Emma Guttman-Yassky, Deborah A. Meyers, George O’Connor, Carole Ober, Peck Y. Ong, Victor E. Ortega, Amy S. Paller, Nirupama Putcha, Robert M. Reed, Lynda C. Schneider, Edwin K. Silverman, Mark K. Slifka, Jonathan M. Spergel, Ramachandran S. Vasan, Karine A. Viaud-Martinez, Harold Watson, Scott T. Weiss, Ingo Ruczinski, Terri H. Beaty, Rasika A. Mathias, Kathleen C. Barnes
Journal: Journal of Allergy and Clinical Immunology (2021)
Efficacy and Safety of Lumateperone for Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder: A Phase 3 Randomized Placebo-Controlled Trial
Authors: Joseph R. Calabrese, Suresh Durgam, Andrew Satlin, Kimberly E. Vanover, Robert E. Davis, Richard Chen, Susan G. Kozauer, Sharon Mates, Gary S. Sachs
Journal: American Journal of Psychiatry (2021)

Objective: In a phase 3 randomized double-blind placebo-controlled study, the authors investigated the efficacy and safety of 42 mg/day of lumateperone in patients with bipolar I or bipolar II disorder experiencing a major depressive episode. Methods: Patients 18–75 years old with a clinical diagnosis of bipolar I or bipolar II disorder and experiencing a major depressive episode were eligible for the study. Patients were randomized in a 1:1 ratio to receive 42 mg/day of lumateperone (N=188) or placebo (N=189), administered orally once daily in the evening for 6 weeks. The primary and key secondary efficacy endpoints were change from baseline to day 43 in score on the Montgomery-Åsberg Depression Rating Scale (MADRS) and total score on the Clinical Global Impressions Scale–Bipolar Version severity scale (CGI-BP-S), respectively. Safety assessments included treatment-emergent adverse events, laboratory parameters, vital signs, extrapyramidal symptoms, and suicidality. Results: At day 43, lumateperone treatment was associated with significantly greater improvement from baseline in MADRS score compared with placebo (least squares mean difference compared with placebo, −4.6 points; effect size=−0.56) and CGI-BP-S total score (least squares mean difference compared with placebo, −0.9; effect size=−0.46). Significant MADRS superiority for lumateperone over placebo was observed both in patients with bipolar I and bipolar II disorders. Somnolence and nausea were the only treatment-emergent adverse events that occurred with lumateperone at a clinically meaningful greater rate than placebo. The incidence of extrapyramidal symptom–related treatment-emergent adverse events was low and similar to that for placebo. Minimal changes were observed in weight, vital signs, or metabolic or endocrine assessments. Conclusions: Lumateperone at 42 mg/day significantly improved depression symptoms and was generally well tolerated in patients with major depressive episodes associated with both bipolar I and bipolar II disorders.
Tackling sexist inequality in medical school
Authors: Freya E Webb, Kate Gibbons, Nina L El-Ahwany
Journal: BMJ (2021)

As female medical students, we are not surprised that the BMA’s sexism in medicine survey found that nine out of 10 female doctors have experienced sexism at work.1 Nor would we be surprised if similar statistics were found among female medical students. In 2021 alone our experiences include, but are not limited …
Development of a breast cancer-specific prognostic tool using CancerLinQ Discovery.
Authors: Emily Miller Ray, Xinyi Zhang, Lisette Dunham, Xianming Tan, Jennifer Elston Lafata, Katherine Elizabeth Reeder-Hayes
Journal: Journal of Clinical Oncology (2021)

275 Background: Oncologists often struggle to know which patients are near end of life to enable a timely transition to supportive care. We developed a breast cancer-specific prognostic tool, using electronic health record data from CancerLinQ Discovery (CLQD), to help identify patients at high risk of near-term death. We created multiple candidate models with varying thresholds for defining high risk that will be considered for future clinical use. Methods: We included patients with breast cancer diagnosed between 1/1/2000 to 6/1/2020 who had at least one encounter with vital signs and evidence of metastatic breast cancer (MBC). All encounters from 1/1/2000 to 7/5/2020 were included. We used multiple imputation (MI) to impute missing numeric variables and treated missing values as a new level for categorical variables. We sampled one encounter per patient and oversampled within 30 days of death, so that the event rate (death within 30 days of encounter) was about 10%. We randomly divided these patients into training (70%) and test datasets (30%). We evaluated candidate predictors of the event using logistic regression with forward variable selection. Candidate predictors included age, vital signs, laboratory values, performance status, pain score, time since chemotherapy, and ER/PR/HER2 receptor status, and change from baseline and change rate of numeric variables. We obtained a single final model by combining resulted logistic regression model from 10 MI training sets. We evaluated this final model on the MI test sets. We varied the alert threshold (i.e., high-risk proportion) from 5% to 40%. Results: We identified 9,270 patients, representing 586,801 encounters. Significant predictors of mortality were: increased age, decreased age at diagnosis, negative change in body mass index, low albumin, high ALP, high AST, high WBC, low sodium, high creatinine, worse performance status, low pulse oximetry, increased age with increased creatinine, high pain score with no opiates, increased pulse rate, unknown/missing PR, opiate use in past 3 months, and prior chemotherapy in past 1 year but not past 30 days. Candidate models had prediction accuracy of 70-89% and positive predictive value of 31-77%. Conclusions: Demographic and clinical variables can be used to predict risk of death within 30 days of a clinical encounter for patients with MBC. Next steps include selection of a preferred model for clinical use, balancing performance characteristics and acceptability, followed by implementation and evaluation of the prognostic tool in the clinic. Candidate models, varying by threshold or percentage of patients assumed to be at high risk, for the outcome of death within 30 days among patients with metastatic breast cancer.[Table: see text]
Immune thrombocytopenia and covid-19: A single centre experience
Authors: M. M. Carbonell, E. G. Gomez, N. E. Lara, A. G. Martinez, C. H. Mata, S. M. C. Ramos, M. C. Marin, A. L. Pena, C. R. Lefler, A. J. G. Ortego, P. Marino, I. Garcia
Journal: HemaSphere (2021)

Immune thrombocytopenia (ITP) is an acquired autoimmune disorder defined by a platelet count   30 × 109 /L (partial response-PR) or level reached > 100 × 109 /L or up to baseline count of that patient (complete response-CR). The results are expressed in percentages for qualitative variables, and in means and interquartilic ranges for continuous variables. The data were included in an Excel database (Microsoft.) and the IBM SPSS Statistics. 20 program was used for their analysis. Results: A total of 27 patients were identified, 17 males (62.96%) and 10 females (37.03%). The mean age at the time of the event was 78 years old (interquartile range-IQR-: 28 years). Attending to severity, 15 had severe disease (55.5%), 9 moderate and only 3 patients (11%) had a mild presentation. The mean time from first COVID-19 manifestations to first ITP expression was 5 days (0-23). and in most of our patients was an incidental finding, presenting only 22% haemorragic clinic associated. The majority of patients in our study did not receive a specific treatment for suspected ITP (e.g. only 6 were treated with intravenous immunoglobulins which were needed due to bleeding). But most patients were already treated with low doses of steroids as part of their treatment for COVID-19. The response rate was about 63% (PR and CR), with a mean of response of six days (IQR of 6.5 days). Patients with severe disease and those who died at the end of the study, had lower platelet count than survivors and patients with moderate disease. However, our differences were not statisticaly significant. Summary/Conclusion: In our study, ITP was more frequent in severe COVID-19, with lower nadir platelet count, as described in literature. Bleeding events were infrequent. Glucocorticoids were used as a treatment for COVID-19 disease, only used in few patients as ITP specific treatment. The results should be confirmed with prospective randomized controlled studies.
Competence Is About Skill, Not Procedure Case Numbers
Authors: Anthony G. Gallagher, Alexandre Mottrie, Richard L. Angelo
Journal: JAMA Surgery (2021)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Surgery HomeNew OnlineCurrent IssueFor Authors Podcast Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Surgery journal
Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: an individual participant data meta-analysis
Authors: Caroline Ovadia, Jenna Sajous, Paul Townsend Seed, Kajol Patel, Nicholas J Williamson, George Attilakos, Francesco Azzaroli, Yannick Bacq, Linoy Batsry, Kelsey Broom, Romana Brun-Furrer, Laura Bull, Jenny Chambers, Yue Cui, Min Ding, Peter Dixon, Maria Estiu, Fergus Gardiner, Victoria Geenes, Monika Grymowicz, Berrin Gunaydin, William Hague, Christian Haslinger, Yayi Hu, Ugo Indraccolo, Alexander Juusela, Stefan Kane, Ayse Kebapcilar, Levent Kebapcilar, Katherine Kohari, Jurate Kondrackiene, Maria Koster, Richard Lee, Xiaohua Liu, Anna Locatelli, Rocio Macias, Riza Madazli, Agata Majewska, Kasia Maksym, Jessica Marathe, Adam Morton, Martijn Oudijk, Deniz Oztekin, Michael Peek, Andrew Shennan, Rachel Tribe, Valeria Tripodi, Naciye Turk Ozterlemez, Tharni Vasavan, L.F. Audris Wong, Yoav Yinon, Qianweng Zhang, Keren Zloto, Hanns-Ulrich Marschall, Jim Thornton, Lucy Chappell, Catherine Williamson
Journal: The Lancet. Gastroenterology & hepatology (2021)
Gene splicing SETs the scene for cocaine addiction
Authors: Purva Bali, Paul J. Kenny
Journal: Neuron (2021)

Cocaine triggers gene splicing in brain reward circuits, but the mechanisms and importance of this response are unclear. In this issue of Neuron, Xu et al. (2021) show that the histone modification H3K36me3 marks genes spliced in response to cocaine and, using epigenome editing, establish a causal relationship between gene splicing and addiction-related behavioral responses.
Cardiac sarcoidosis: systematic review of the literature on corticosteroid and immunosuppressive therapies
Authors: Julien Stievenart, Guillaume Le Guenno, Marc Ruivard, Virginie Rieu, Marc André, Vincent Grobost
Journal: European Respiratory Journal (2021)

Background Cardiac sarcoidosis (CS) is a life-threatening condition in which clear recommendations are lacking. We aimed to systematically review the literature on cardiac sarcoidosis treated by corticosteroids and/or immunosuppressive agents in order to update the management of CS. Methods Using PubMed, Embase and Cochrane Library databases, we found original articles on corticosteroid and standard immunosuppressive therapies for CS that provided at least a fair Scottish Intercollegiate Guidelines Network (SIGN) overall assessment of quality and we analysed the relapse rate, major cardiac adverse events (MACEs) and adverse events. We based our methods on the PRISMA statement and checklist. Results We retrieved 21 studies. Mean quality provided by SIGN assessment was 6.8 out of 14 (range 5–9). Corticosteroids appeared to have a positive impact on left ventricular function, atrioventricular block and ventricular arrhythmias. For corticosteroids alone, nine studies (45%, n=351) provided data on relapses, representing an incidence of 34% (n=119). Three studies (14%, n=73) provided data on MACEs (n=33), representing 45% of MACEs in patients treated by corticosteroid alone. Nine studies provided data on adjunctive immunosuppressive therapy, of which four studies (n=78) provided data on CS relapse, representing an incidence of 33% (n=26). Limitations consisted of no randomised control trial retrieved and unclear data on MACEs in patients treated by combined immunosuppressive agents and corticosteroids. Conclusion Corticosteroids should be started early after diagnosis but the exact scheme is still unclear. Studies concerning adjunctive conventional immunosuppressive therapies are lacking and benefits of adjunctive immunosuppressive therapies are unclear. Homogenous data on CS long-term outcomes under corticosteroids, immunosuppressive therapies and other adjunctive therapies are lacking.
Keratinocyte membrane-mediated nanodelivery system with dissolving microneedles for targeted therapy of skin diseases
Authors: Qian Jing, Hang Ruan, Jiaqi Li, Zhi Wang, Lixia Pei, Hongmei Hu, Zehui He, Tong Wu, Shuyao Ruan, Teng Guo, Youjie Wang, Nianping Feng, Yongtai Zhang
Journal: Biomaterials (2021)
Gut microbiota depletion exacerbates cholestatic liver injury via loss of FXR signalling
Authors: Kai Markus Schneider, Lena Susanna Candels, Johannes R. Hov, Maiju Myllys, Reham Hassan, Carolin Victoria Schneider, Annika Wahlström, Antje Mohs, Sebastian Zühlke, Lijun Liao, Carsten Elfers, Konrad Kilic, Marcus Henricsson, Antonio Molinaro, Maximilian Hatting, Ayham Zaza, Dirk Drasdo, Mick Frissen, A. Sloan Devlin, Eric J. C. Gálvez, Till Strowig, Tom H. Karlsen, Jan G. Hengstler, Hanns-Ulrich Marschall, Ahmed Ghallab, Christian Trautwein
Journal: Nature Metabolism (2021)
Investigation of an Outbreak of COVID-19 in a French Nursing Home With Most Residents Vaccinated
Authors: Catherine Burugorri-Pierre, Carmelo Lafuente-Lafuente, Christel Oasi, Emmanuel Lecorche, Sylvie Pariel, Cristiano Donadio, Joël Belmin
Journal: JAMA Network Open (2021)

There is great hope that vaccination against SARS-CoV-2 will decrease the burden of COVID-19 on nursing home (NH) residents, who have been significantly affected by this pandemic. The efficacy and effectiveness of COVID-19 vaccines are not well known in this population. Recent immunogenic studies have found decreased titers of postvaccine neutralizing antibodies against SARS-CoV-2 among NH residents, suggesting the potential for diminished effectiveness in this population.1,2 We report an outbreak of COVID-19 in a French nursing home where most residents had been fully vaccinated with the BNT162b2 vaccine.
Reactive oxygen species-activatable self-amplifying Watson-Crick base pairing-inspired supramolecular nanoprodrug for tumor-specific therapy
Authors: Xiaoyu Xu, Zishan Zeng, Xin Ding, Ting Shan, Qiuxing Liu, Meixu Chen, Jie Chen, Meng Xia, Yuanfeng He, Zeqian Huang, Yanjuan Huang, Chunshun Zhao
Journal: Biomaterials (2021)
Effect of Low-Dose Methotrexate on eGFR and Kidney Adverse Events: A Randomized Clinical Trial
Authors: Jeffrey A. Sparks, Kathleen M. M. Vanni, Matthew A. Sparks, Chang Xu, Leah M. Santacroce, Robert J. Glynn, Paul M. Ridker, Daniel H. Solomon
Journal: Journal of the American Society of Nephrology (2021)

Significance Statement Methotrexate can lead to kidney injury at high doses for cancer and is contraindicated in advanced CKD. The effect of low-dose methotrexate (LD-MTX, ≤25 mg weekly) on eGFR and kidney adverse events (AEs) with normal kidney function or mild-to-moderate CKD is unclear. In this clinical trial that included 4786 adults with cardiovascular disease and no systemic rheumatic condition, participants randomized to LD-MTX had less decline in eGFR over 23-month median follow-up compared with placebo. Those randomized to LD-MTX had a 27% reduced rate of kidney AEs on safety laboratory monitoring compared with placebo. These results demonstrate the kidney safety of LD-MTX among patients with normal kidney function or mild-to-moderate CKD. Background Low-dose methotrexate (LD-MTX) is contraindicated in advanced CKD, but kidney safety in normal kidney function or mild-to-moderate CKD is less clear. Methods We performed a secondary analysis for eGFR and kidney AEs using the randomized double-blind, placebo-controlled Cardiovascular Inflammation Reduction Trial. Adults with cardiovascular disease and diabetes and/or metabolic syndrome were randomly allocated to oral LD-MTX (target dose 15–20 mg/week) or placebo. All participants took folic acid 1 mg 6 days/week. Exclusion criteria included systemic rheumatic disease and creatinine clearance &lt;40 ml/min. The least-squares mean Δ eGFR from baseline was calculated at each study visit; the difference in eGFR between LD-MTX and placebo was compared. We used Cox proportional hazard models to compare rates of kidney AEs for LD-MTX versus placebo. Results A total of 2391 participants were randomized to LD-MTX and 2395 to placebo. At baseline, the mean age was 66 years, 19% were female, and mean eGFR was 80.0 ml/min per 1.73 m 2 (54% had Stage 2 CKD and 18% had Stage 3 CKD). Median follow-up was 23 months. The LD-MTX group had less decline in eGFR than placebo (difference in least-squares mean ΔeGFR from baseline to on-treatment visits: 0.93 ml/min per 1.73 m 2 , 95% confidence interval [95% CI], 0.45 to 1.40, P &lt;0.001). There were 138 (incidence rate [IR], 2.97 per 100 person-years) kidney AEs in the LD-MTX group and 184 (IR, 3.99 per 100 person-years) among placebo (hazard ratio [HR] 0.73, 95% confidence interval [95% CI], 0.59 to 0.91) during safety laboratory monitoring. Conclusions These results demonstrate the kidney safety of LD-MTX among patients with normal kidney function or mild-to-moderate CKD at baseline.
Dietary intakes of monounsaturated fatty acids and risk of mortality from all causes, cardiovascular disease and cancer: A systematic review and dose-response meta-analysis of prospective cohort studies
Authors: Keyhan Lotfi, Asma Salari-Moghaddam, Mahsa Yousefinia, Bagher Larijani, Ahmad Esmaillzadeh
Journal: Ageing Research Reviews (2021)
Direct or Direct-Like Stenting in Acute Stemi with High-Grade Thrombus: A Clinical Case Series
Authors: Rohit Mody
Journal: Clinical Cardiology and Cardiovascular Interventions (2021)

We consider herewith acute ST-elevation myocardial infarction cases having high grade thrombus who underwent direct stenting or direct like stenting of the culprit vessel in those a drug-eluting stent was not crossable directly or distal landing zone was not visible directly after successful guidewire navigation in distal true lumen. All the 4 patients had presented with acute STEMI and high-grade thrombus on angiography. All of them were treated with percutaneous coronary intervention incorporating either direct stenting or direct like stenting. All had a very good angiographic outcome with TIMI 3 flow and MBG &gt;/= 2. In most patients with acute STEMI and high-grade thrombus, direct or direct-like stenting is possible, it simplifies the procedure with almost nil on table complications. Twee table abstract Direct and direct-like stenting in patients with high grade thrombus with STEMI is possible in most of the patients. It resulted in TIMI 3 flow and MBG 2 in all our patients. None of them had no-reflow phenomenon. Lay Abstract In any case of ST-elevation MI, time is one of the most important aspects. In this process, it is important to minimize the damage to the heart muscle. Therefore, we need to open the culprit artery in a timely and urgent fashion to restore the blood flow to the heart muscle as quickly as possible. During this restoration of the blood flow, we need to minimize the distal embolization of the clot which may be detrimental to the heart muscle. Here, we describe the cases where we have done stenting directly without touching the clot and that resulted in minimal embolization and better outcomes.
NIR-triggered drug delivery system for chemo-photothermal therapy of posterior capsule opacification
Authors: Mao Ying-Yan, Li Meng, Wang Jin-Da, Wang Kai-Jie, Zhang Jing-Shang, Chen Shu-Ying, Liu Xu, Liang Qing-Feng, Gao Fei, Wan Xiu-Hua
Journal: Journal of Controlled Release (2021)