tbuckley/cabot-search huggingface dataset:
Effect of Zuranolone vs Placebo in Postpartum Depression
Authors: Kristina M. Deligiannidis, Samantha Meltzer-Brody, Handan Gunduz-Bruce, James Doherty, Jeffrey Jonas, Sigui Li, Abdul J. Sankoh, Christopher Silber, Andrew D. Campbell, Brian Werneburg, Stephen J. Kanes, Robert Lasser
Journal: JAMA Psychiatry (2021)

Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy, negatively affecting both mother and child.To demonstrate the efficacy and safety of zuranolone, a neuroactive steroid γ-aminobutyric acid receptor-positive allosteric modulator, in PPD.This phase 3, double-blind, randomized, outpatient, placebo-controlled clinical trial was conducted between January 2017 and December 2018 in 27 enrolling US sites. Participant were women aged 18 to 45 years, 6 months or fewer post partum, with PPD (major depressive episode beginning third trimester or ≤4 weeks postdelivery), and baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) score of 26 or higher. Analysis was intention to treat and began December 2018 and ended March 2019.Randomization 1:1 to placebo:zuranolone, 30 mg, administered orally each evening for 2 weeks.Primary end point was change from baseline in HAMD-17 score for zuranolone vs placebo at day 15. Secondary end points included changes from baseline in HAMD-17 total score at other time points, HAMD-17 response (≥50% score reduction) and remission (score ≤7) rates, Montgomery-Åsberg Depression Rating Scale score, and Hamilton Rating Scale for Anxiety score. Safety was assessed by adverse events and clinical assessments.Of 153 randomized patients, the efficacy set comprised 150 patients (mean [SD] age, 28.3 [5.4] years), and 148 (98.7%) completed treatment. A total of 76 patients were randomized to placebo, and 77 were randomized to zuranolone, 30 mg. Zuranolone demonstrated significant day 15 HAMD-17 score improvements from baseline vs placebo (-17.8 vs -13.6; difference, -4.2; 95% CI, -6.9 to -1.5; P = .003). Sustained differences in HAMD-17 scores favoring zuranolone were observed from day 3 (difference, -2.7; 95% CI, -5.1 to -0.3; P = .03) through day 45 (difference, -4.1; 95% CI, -6.7 to -1.4; P = .003). Sustained differences at day 15 favoring zuranolone were observed in HAMD-17 response (odds ratio, 2.63; 95% CI, 1.34-5.16; P = .005), HAMD-17 score remission (odds ratio, 2.53; 95% CI, 1.24-5.17; P = .01), change from baseline for Montgomery-Åsberg Depression Rating Scale score (difference, -4.6; 95% CI, -8.3 to -0.8; P = .02), and Hamilton Rating Scale for Anxiety score (difference, -3.9; 95% CI, -6.7 to -1.1; P = .006). One patient per group experienced a serious adverse event (confusional state in the zuranolone group and pancreatitis in the placebo group). One patient in the zuranolone group discontinued because of an adverse event vs none for placebo.In this randomized clinical trial, zuranolone improved the core symptoms of depression as measured by HAMD-17 scores in women with PPD and was generally well tolerated, supporting further development of zuranolone in the treatment of PPD.ClinicalTrials.gov Identifier: NCT02978326.
Phase I study of adjuvant chemotherapy with gemcitabine plus cisplatin in patients with biliary tract cancer undergoing curative resection without major hepatectomy (KHBO1004).
Authors: Masanori Toyoda, Tetsuo Ajiki, Yutaka Fujiwara, Hiroaki Nagano, Shogo Kobayashi, Daisuke Sakai, Etsuro Hatano, Masashi Kanai, Shoji Nakamori, Atsushi Miyamoto, Akihito Tsuji, Satoshi Kaihara, Hisashi Ikoma, Shigekazu Takemura, Hideyoshi Toyokawa, Hiroaki Terajima, Tatsuya Ioka
Journal: Journal of Clinical Oncology (2014)

347 Background: GC has become a standard chemotherapy for patients with locally advanced or metastatic BTC. The benefit of adjuvant therapy for BTC is unclear, however, it is used worldwide due to BTC’s dismal prognosis. We conducted a phase I study for adjuvant chemotherapy with GC in patients with BTC in order to determine the maximum-tolerated dose (MTD) and recommended dose (RD). Methods: Patients with BTC were eligible if they met the following criteria: Stage IB or higher; undergoing resection without major hepatectomy; over 20 years of age; ECOG PS 0-1; adequate organ functions. The starting dose (Level 1) of GC was the same as the standard dose of advanced disease and dose was planned to adjust, using a 3+3 design with cohorts of 3-6 patients and further cohort expansion took place. The Dose Limiting Toxicities (DLTs) were determined during the first six weeks and RD was determined through the entire treatment. Results: One DLT out of 6 patients, with grade 4 neutropenia, was observed at Level 1 and an expanded cohort was further examined. A total of eighteen patients were enrolled and one DLT was observed as described above. During the first six weeks, the most common grade 3 or 4 related adverse events were neutropenia (n=10: 56%) and leukopenia (n=6: 33%). Through the entire treatment, non-hematologic toxicities were manageable. Seven (39%) patients completed the protocol treatment, seven (39%) dropped off due to the need of second time dose reduction, two didn’t meet starting criteria of creatinin with grade 1 increase in CTCAE, one had rapid tumor progression died within 30 days after the last administration of GC and one withdrew after reporting dead case. Conclusions: A standard dose of GC might be feasible for adjuvant chemotherapy for BTC undergoing curative resection without major hepatectomy. We selected standard dose of GC as RD for a subsequent phase II study. Clinical trial information: NCT01297998.
Impact of Early Post-Transplant 5-Point Deauville Scale (18)F-FDG-PET Status on Survival Outcomes after Allogeneic Transplantation for Lymphoma
Authors: Louise Bouard, Caroline Bodet-Milin, Thierry Guillaume, Pierre Peterlin, Clement Bailly, Alice Garnier, Amandine Le Bourgeois, Beatrice Mahe, Viviane Dubruille, Nicolas Blin, Pierre Gallas, Cyrille Touzeau, Thomas Gastinne, Anne Lok, Lucie Planche, Steven Le Gouill, Philippe Moreau, Francoise Kraeber-Bodere, Patrice Chevallier
Journal: Blood (2017)
Chemokine Receptor 4–Targeted 68Ga-Pentixafor PET/CT in Response Assessment of Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma
Authors: Qingqing Pan, Xinxin Cao, Yaping Luo, Jian Li, Fang Li
Journal: Clinical Nuclear Medicine (2021)

Purpose 68 Ga-pentixafor PET/CT was reported to have a high sensitivity in detecting tumor involvement of Waldenström macroglobulinemia/lymphoplasmacytic lymphoma (WM/LPL) in our previous study. We aimed to further investigate its value in response assessment in WM/LPL. Patients and Methods Fifteen patients with WM/LPL were recruited in a prospective cohort study and underwent both 68 Ga-pentixafor and 18 F-FDG PET/CT at baseline and posttreatment. PET/CT-based responses were analyzed with visual assessments and compared with clinical response. Results At baseline, all of the 15 patients had a positive 68 Ga-pentixafor PET/CT scan, whereas 18 F-FDG PET/CT was positive in 11/15 patients. After chemotherapy, the overall response rate was 86.7% (13/15), and 68 Ga-pentixafor PET/CT showed different degree of tumor response from baseline in these patients. In the 2 patients with progressive disease, 68 Ga-pentixafor PET/CT detected new lesions or remarkable increase of 68 Ga-pentixafor uptake in tumor involvements. However, 18 F-FDG PET/CT failed to detect the improvement of disease in 6/13 patients and missed disease progression in 1 of the 2 patients. Conclusions 68 Ga-pentixafor PET/CT outperformed 18 F-FDG PET/CT in response assessment of WM/LPL.
Inflammatory biomarker kinetics in COVID-19
Authors: A. Cohen, G. Carey, S. Pitafi, Y. Kunitomo, D. A. Tsang, S. Gautam, C. Dela Cruz
Journal: American Journal of Respiratory and Critical Care Medicine (2021)

RATIONALE: Biomarkers such as procalcitonin (PCT), ferritin, and D-dimer are widely used to guide the management of COVID-19. In particular, PCT has been utilized as an indicator for secondary bacterial infection, and D-dimer for venous thromboembolism. To better understand the clinical significance of these biomarkers, we studied their kinetics in two contrasting populations: patients with mild versus fulminant disease. METHODS: We conducted a retrospective cohort study of 739 adult patients hospitalized at Yale-New Haven Hospital with COVID-19 infection. Patients with mild disease were defined by recovery and eventual discharge;those with fulminant disease were defined by death during hospitalization. Patients were systematically tested for PCT, ferritin, and D-dimer;each was measured at least once every 30h on average. Biomarker data was subjected to transformation to satisfy the assumptions for linear regression analysis. The Mann-Whitney U test was used for comparison throughout given non-normal data distributions. RESULTS: Upon admission, PCT and D-dimer levels were significantly higher in patients admitted to the intensive care unit (median 0.21 ng/mL and 1.30 mg/L FEU) than in those admitted to general medical wards (median 0.10 ng/mL and 0.92 mg/L FEU) (p<0.001;p<0.001). Terminal PCT values during admission were 11.9 times higher in patients with fulminant versus mild disease (p<0.001) and terminal D-dimer values were 3.5 times higher (p<0.001). Linear regression analysis was used to assess the dynamics of PCT and D-dimer over time. During the first 21 days, both biomarkers decreased markedly in patients with mild disease (negative slopes of -0.12 ng/mL/day and -0.10 mg/L FEU/day) and increased in those with fulminant disease (positive slopes of 0.13 ng/mL/day and 0.51 mg/L FEU/day) (p<0.01;p<0.001). Rather than demonstrating divergent patterns determined by complications such as bacterial superinfection and thromboembolism, all three biomarkers trended closely together, as PCT correlated with both ferritin (R=0.39) and D-dimer (R=0.31). CONCLUSION: Our analysis of biomarker kinetics suggests that PCT, ferritin, and D-dimer may represent general indices of COVID-19 severity rather than specific markers of secondary complications. These results are consistent with decades of studies in sepsis, which have shown nonspecific elevation of inflammatory biomarkers. Further research is necessary to clarify their clinical relevance and diagnostic utility in COVID-19. ∗Nota bene: AC and GC contributed equally to this work and therefore may be listed in either order.
Predictive Value of EGFR Mutation in Locally Advanced Adenocarcinoma of the Lung Treated with Concurrent Chemoradiotherapy
Authors: Yamamoto N, Endo M, Harada H, Takahashi T, Naito T, Kennmotsu T, Nakamura Y, Akamatasu H, Kaira K, Murakami H, Ono A, Tsuya A
Journal: Journal of Thoracic Oncology (2010)
Stopping mineralocorticoid receptor antagonists after hyperkalaemia: trial emulation in data from routine care
Authors: Marco Trevisan, Edouard L. Fu, Yang Xu, Gianluigi Savarese, Friedo W. Dekker, Lars H. Lund, Catherine M. Clase, Arvid Sjölander, Juan J. Carrero
Journal: European Journal of Heart Failure (2021)
Considerations for Reducing Bias While Addressing Racial/Ethnic Disparities in Academic Surgery
Authors: Alexander J. Acuña, Tarun K. Jella, Atul F. Kamath
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
Pravastatin Versus Placebo in Pregnancies at High Risk of Term Preeclampsia
Authors: Moritz Döbert, Anna Nektaria Varouxaki, An Chi Mu, Argyro Syngelaki, Anca Ciobanu, Ranjit Akolekar, Catalina De Paco Matallana, Simona Cicero, Elena Greco, Mandeep Singh, Deepa Janga, Maria del Mar Gil, Jacques C. Jani, José Luis Bartha, Kate Maclagan, David Wright, Kypros H. Nicolaides
Journal: Circulation (2021)

Background: Effective screening for term preeclampsia is provided by a combination of maternal factors with measurements of mean arterial pressure, serum placental growth factor, and serum soluble fms-like tyrosine kinase-1 at 35 to 37 weeks of gestation, with a detection rate of ≈75% at a screen-positive rate of 10%. However, there is no known intervention to reduce the incidence of the disease. Methods: In this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1120 women with singleton pregnancies at high risk of term preeclampsia to receive pravastatin at a dose of 20 mg/d or placebo from 35 to 37 weeks of gestation until delivery or 41 weeks. The primary outcome was delivery with preeclampsia at any time after randomization. The analysis was performed according to intention to treat. Results: A total of 29 women withdrew consent during the trial. Preeclampsia occurred in 14.6% (80 of 548) of participants in the pravastatin group and in 13.6% (74 of 543) in the placebo group. Allowing for the effect of risk at the time of screening and participating center, the mixed-effects Cox regression showed no evidence of an effect of pravastatin (hazard ratio for statin/placebo, 1.08 [95% CI, 0.78–1.49]; P =0.65). There was no evidence of interaction between the effect of pravastatin, estimated risk of preeclampsia, pregnancy history, adherence, and aspirin treatment. There was no significant between-group difference in the incidence of any secondary outcomes, including gestational hypertension, stillbirth, abruption, delivery of small for gestational age neonates, neonatal death, or neonatal morbidity. There was no significant between-group difference in the treatment effects on serum placental growth factor and soluble fms-like tyrosine kinase-1 concentrations 1 and 3 weeks after randomization. Adherence was good, with reported intake of ≥80% of the required number of tablets in 89% of participants. There were no significant between-group differences in neonatal adverse outcomes or other adverse events. Conclusions: Pravastatin in women at high risk of term preeclampsia did not reduce the incidence of delivery with preeclampsia. Registration: URL: https://www.isrctn.com ; Unique identifier ISRCTN16123934.
Self-reported measures of training exposure: can we trust them, and how do we select them?
Authors: Myles Calder Murphy, Philip Glasgow, Andrea Britt Mosler
Journal: British Journal of Sports Medicine (2021)

Valid methods of quantifying sporting exposure and athlete response are essential to answering many sports injury research questions. External measures of exposure describe volume, duration or intensity of a match or training session and include time (eg, hours spent training), distance (eg, metres run) and number of events (eg, number of baseball pitches).1 Internal measures relate to the effect on, or experience of, an athlete during a session and include both subjective (eg, rating of percieved exertion (RPE)) and objective measures (eg, heart rate).1 

Accurately recording exposure allows the direct comparison of injury incidence rates between different populations, sports, seasons and anatomical region, and should be accounted for in risk factor analyses.1 In addition to inconsistent terminology used to define injury and performance, the validity of any such analysis is dependent on the accuracy of the exposure data collected. Given the multifactorial nature of injury risk, a range of measures that reflect the physiological, psychological and biomechanical exposure load should be considered rather than focusing on a single metric.

It is easy to fall into the trap of quantifying exposure metrics which are easily measured. Substantial …
Analysis of Genetic Variants Related to the Hepatic Veno-Occlusive Disease in Pediatric Patients Receiving HSCT with Targeted Dose Busulfan Based Conditioning
Authors: Jung Yoon Choi, Heewon Seo, Yoomi Park, ByungJoo Min, Hyery Kim, Kyung Taek Hong, Che Ry Hong, Sang Hoon Song, Kyung-Sang Yu, In-Jin Jang, Kyung Duk Park, Hee Young Shin, Ju Han Kim, Hyoung Jin Kang
Journal: Blood (2017)
Impact of lung function on cardiovascular diseases and cardiovascular risk factors: a two sample bidirectional Mendelian randomisation study
Authors: Shiu Lun Au Yeung, Maria Carolina Borges, Debbie A Lawlor, C Mary Schooling
Journal: Thorax (2021)

Introduction Observational studies suggested lung function is inversely associated with cardiovascular disease (CVD) although these studies could be confounded. We conducted a two sample Mendelian randomisation study using summary statistics from genome-wide association studies (GWAS) to clarify the role of lung function in CVD and its risk factors, and conversely the role of CVD in lung function. Methods We obtained genetic instruments for forced expiratory volume in 1 s (FEV 1 : 260) and forced vital capacity (FVC: 320) from publicly available UK Biobank summary statistics (n=421 986) and applied to GWAS summary statistics for coronary artery disease (CAD) (n=184 305), stroke (n=446 696), atrial fibrillation (n=1 030 836) and heart failure (n=977 320) and cardiovascular risk factors. Inverse variance weighting was used to assess the impact of lung function on these outcomes, with various sensitivity analyses. Bidirectional Mendelian randomisation was used to assess reverse causation. Results FEV 1 and FVC were inversely associated with CAD (OR per SD increase, 0.72 (95% CI 0.63 to 0.82) and 0.70 (95%CI 0.62 to 0.78)), overall stroke (0.87 (95%CI 0.77 to 0.97), 0.90 (95% CI 0.82 to 1.00)) and some stroke subtypes. FEV 1 and FVC were inversely associated with type 2 diabetes and systolic blood pressure. Sensitivity analyses produced similar findings although the association with CAD was attenuated after adjusting for height (eg, OR for 1SD FEV 1 0.95 (0.75 to 1.19), but not for stroke or type 2 diabetes. There was no strong evidence for reverse causation. Conclusion Higher lung function likely protect against CAD and stroke.
Annals Graphic Medicine - See/Draw: A COVID-19 Distraction
Authors: William J. Doan
Journal: Annals of Internal Medicine (2021)

Web Exclusives29 June 2021Annals Graphic Medicine - See/Draw: A COVID-19 DistractionFREEWilliam J. Doan, BA, MFA, PhDWilliam J. Doan, BA, MFA, PhDPenn State University, University Park, Pennsylvania (W.J.D.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/G20-0111 SectionsAboutVisual AbstractPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Download figure Download PowerPoint Download figure Download PowerPoint Download figure Download PowerPoint Download figure Download PowerPoint Download figure Download PowerPoint Download figure Download PowerPoint Download figure Download PowerPoint Download figure Download PowerPoint Download figure Download PowerPoint Author, Article, and Disclosure InformationAuthors: William J. Doan, BA, MFA, PhDAffiliations: Penn State University, University Park, Pennsylvania (W.J.D.)Disclosures: The author has reported no disclosures of interest. The form can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=G20-0111.Author/Illustrator Information: William J. Doan, BA, MFA, PhD, is an artist and scholar whose work includes visual art, solo performance, and playwriting. He is currently Director of the Arts and Design Research Incubator at the Pennsylvania State University, serving as an artist-in-residence in the College of Nursing and the 2019-2020 Penn State Laureate.This article was published at Annals.org on 29 June 2021. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byGraphic medicine meets human anatomy: The potential role of comics in raising whole body donation awareness in Italy and beyond. A pilot study July 2021Volume 174, Issue 7 Page: W68-W77 ePublished: 29 June 2021 Issue Published: July 2021 Copyright & PermissionsCopyright © 2021 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...
Early diagnosis of frailty: Technological and non-intrusive devices for clinical detection
Authors: Francisco Anabitarte-García, Luis Reyes-González, Luis Rodríguez-Cobo, Carlos Fernández-Viadero, Silvia Somonte-Segares, Sara Díez-del-Valle, Eneritz Mandaluniz, Roberto García-García, José M. López-Higuera
Journal: Ageing Research Reviews (2021)

This work analyses different concepts for frailty diagnosis based on affordable standard technology such as smartphones or wearable devices. The goal is to provide ideas that go beyond classical diagnostic tools such as magnetic resonance imaging or tomography, thus changing the paradigm; enabling the detection of frailty without expensive facilities, in an ecological way for both patients and medical staff and even with continuous monitoring. Fried's five-point phenotype model of frailty along with a model based on trials and several classical physical tests were used for device classification. This work provides a starting point for future researchers who will have to try to bridge the gap separating elderly people from technology and medical tests in order to provide feasible, accurate and affordable tools for frailty monitoring for a wide range of users.