Vibeke Strand, Susan H Boklage, Toshio Kimura, Florence Joly, Anita Boyapati, Jérôme Msihid
BACKGROUND: Increased levels of cytokines, including interleukin-6 (IL-6), reflect inflammation and have been shown to be predictive of therapeutic responses, fatigue, pain, and depression in patients with rheumatoid arthritis (RA), but limited data exist on associations between IL-6 levels and health-related quality of life (HRQoL). This post hoc analysis of MONARCH phase III randomized controlled trial data evaluated the potential of baseline IL-6 levels to differentially predict HRQoL improvements with sarilumab, a fully human monoclonal antibody directed against both soluble and membrane-bound IL-6 receptor α (anti-IL-6Rα) versus adalimumab, a tumor necrosis factor α inhibitor, both approved for treatment of active RA...
October 20, 2020: Arthritis Research & Therapy
Jessica Barth, Joeseph W Klaesner, Catherine E Lang
BACKGROUND: Standardized assessments are used in rehabilitation clinics after stroke to measure restoration versus compensatory movements of the upper limb. Accelerometry is an emerging tool that can bridge the gap between in- and out-of-clinic assessments of the upper limb, but is limited in that it currently does not capture the quality of a person's movement, an important concept to assess compensation versus restoration. The purpose of this analysis was to characterize how accelerometer variables may reflect upper limb compensatory movement patterns after stroke...
October 20, 2020: Journal of Neuroengineering and Rehabilitation
Sergey Bukhdruker, Tatsiana Varaksa, Irina Grabovec, Egor Marin, Polina Shabunya, Maria Kadukova, Sergei Grudinin, Anton Kavaleuski, Anastasiia Gusach, Andrei Gilep, Valentin Borshchevskiy, Natallia Strushkevich
Spreading of the multidrug-resistant (MDR) strains of the one of the most harmful pathogen Mycobacterium tuberculosis (Mtb) generates the need for new effective drugs. SQ109 showed activity against resistant Mtb and already advanced to Phase II/III clinical trials. Fast SQ109 degradation is attributed to the human liver Cytochrome P450s (CYPs). However, no information is available about interactions of the drug with Mtb CYPs. Here, we show that Mtb CYP124, previously assigned as a methyl-branched lipid monooxygenase, binds and hydroxylates SQ109 in vitro...
October 16, 2020: International Journal of Molecular Sciences
Piera Federico, Angelica Petrillo, Pasqualina Giordano, Davide Bosso, Antonietta Fabbrocini, Margaret Ottaviano, Mario Rosanova, Antonia Silvestri, Andrea Tufo, Antonio Cozzolino, Bruno Daniele
Immune checkpoint inhibitors (ICIs) represent a promising treatment for many kinds of cancers, including hepatocellular carcinoma (HCC). The rationale for using ICIs in HCC is based on the immunogenic background of hepatitis and cirrhosis and on the observation of high programmed death-ligand 1 (PD-L1) expression and tumor-infiltrating lymphocytes in this cancer. Promising data from phase I/II studies in advanced HCC, showing durable objective response rates (~20% in first- and second-line settings) and good safety profile, have led to phase III studies with ICIs as single agents or in combination therapy, both in first and second line setting...
October 18, 2020: Cancers
Mingzhou Gao, Hui Sun, Wenjun Sun, Dongmei Gao, Mingqi Qiao
BACKGROUND: Premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) are common disorders that manifest themselves in the late luteal phase, and significantly interfere with an individual's daily activities. Clinical evidence suggests that traditional Chinese medicine (TCM) may ease PMS/PMDD symptoms. Here, we review a protocol for exploring the effectiveness and safety of TCM in PMS/PMDD management. METHODS: We will conduct a literature search for randomized controlled trials (RCT) for TCM use in PMS/PMDD on PubMed, web of science, EMBASE, the Cochrane central register of controlled trials (Cochrane Library), Chinese national knowledge infrastructure, Chinese VIP Information, Wanfang, as well as Chinese biomedical literature database...
October 16, 2020: Medicine (Baltimore)
John Zizzo
Operation Warp Speed and global vaccine research efforts have succeeded in rapidly launching three vaccine candidates for coronavirus disease 2019 (COVID-19) into Phase III clinical trials. A recent letter from Centers for Disease Control and Prevention (CDC) Director Redfield underscored the possibility of "large-scale" distribution of a coronavirus vaccine as early as November 1, 2020. However, recent polling reveals that the majority of Americans remain skeptical of both the safety and efficacy of a potential Covid-19 vaccine...
October 20, 2020: Human Vaccines & Immunotherapeutics
Paul L Swiecicki, Emily L Bellile, Collin V Brummel, J Chad Brenner, Francis P Worden
BACKGROUND: There are limited treatment options for unresectable recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Vascular endothelial growth factor is of significant interest for targeted therapy in R/M HNSCC because of its central role in tumorigenesis and immunosuppression. Axitinib is a potent inhibitor of vascular endothelial growth factor receptor (VEGFR) 1 , VEGFR2, VEGFR3, platelet-derived growth factor receptor, as well as c-kit and offers such an approach...
October 20, 2020: Cancer
James E Udelson, Gregory D Lewis, Sanjiv J Shah, Michael R Zile, Margaret M Redfield, John Burnett, John Parker, Jelena P Seferovic, Phebe Wilson, Robert S Mittleman, Albert T Profy, Marvin A Konstam
Importance: Heart failure with preserved ejection fraction (HFpEF) is often characterized by nitric oxide deficiency. Objective: To evaluate the efficacy and adverse effects of praliciguat, an oral soluble guanylate cyclase stimulator, in patients with HFpEF. Design, Setting, and Participants: CAPACITY HFpEF was a randomized, double-blind, placebo-controlled, phase 2 trial. Fifty-nine sites enrolled 196 patients with heart failure and an ejection fraction of at least 40%, impaired peak rate of oxygen consumption (peak V̇o2), and at least 2 conditions associated with nitric oxide deficiency (diabetes, hypertension, obesity, or advanced age)...
October 20, 2020: JAMA
Paul W Armstrong, Carolyn S P Lam, Kevin J Anstrom, Justin Ezekowitz, Adrian F Hernandez, Christopher M O'Connor, Burkert Pieske, Piotr Ponikowski, Sanjiv J Shah, Scott D Solomon, Adriaan A Voors, Lilin She, Vanja Vlajnic, Francine Carvalho, Luke Bamber, Robert O Blaustein, Lothar Roessig, Javed Butler
Importance: Patients with heart failure and preserved ejection fraction (HFpEF) are at high risk of mortality, hospitalizations, and reduced functional capacity and quality of life. Objective: To assess the efficacy of the oral soluble guanylate cyclase stimulator vericiguat on the physical limitation score (PLS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ). Design, Setting, and Participants: Phase 2b randomized, double-blind, placebo-controlled, multicenter trial of 789 patients with chronic HFpEF and left ventricular ejection fraction 45% or higher with New York Heart Association class II-III symptoms, within 6 months of a recent decompensation (HF hospitalization or intravenous diuretics for HF without hospitalization), and with elevated natriuretic peptides, enrolled at 167 sites in 21 countries from June 15, 2018, through March 27, 2019; follow-up was completed on November 4, 2019...
October 20, 2020: JAMA
Eiji Kondo, Tsutomu Tabata, Nao Suzuki, Daisuke Aoki, Hideaki Yahata, Yoshio Kotera, Osamu Tokuyama, Keiichi Fujiwara, Eizo Kimura, Fumitoshi Terauchi, Toshiyuki Sumi, Aikou Okamoto, Nobuo Yaegashi, Takayuki Enomoto, Toru Sugiyama
OBJECTIVE: In this study we sought to investigate the clinical factors that affect post-progression survival (PPS) in patients with recurrent or persistent clear cell carcinoma (CCC). We utilized the JGOG3017/Gynecological Cancer InterGroup data to compare paclitaxel plus carboplatin (TC) and irinotecan plus cisplatin (CPT-P) in the treatment of stages I to IV CCC. METHODS: We enrolled 166 patients with recurrent or persistent CCC and assessed the impact of variables, including platinum sensitivity, treatment arm, crossover chemotherapy, primary stage, residual tumor at primary surgery, performance status, ethnicity, and tumor reduction surgery at recurrence on the median of PPS in patients with recurrent or persistent CCC...
November 2020: Journal of Gynecologic Oncology
Pablo Guisado-Vasco, Sofia Valderas-Ortega, Maria Maravillas Carralón-González, Ana Roda-Santacruz, Lucia González-Cortijo, Gabriel Sotres-Fernández, Eva María Martí-Ballesteros, José Manuel Luque-Pinilla, Elena Almagro-Casado, Félix J La Coma-Lanuza, Ruth Barrena-Puertas, Esteban Javier Malo-Benages, María José Monforte-Gómez, Rocío Diez-Munar, Esther Merino-Lanza, Lorena Comeche-Casanova, Margarita Remirez-de-Esparza-Otero, María Correyero-Plaza, Manuel Recio-Rodríguez, Margarita Rodríguez-López, María Dolores Sánchez-Manzano, Cristina Andreu-Vázquez, Israel John Thuissard-Vasallo, José María Echave-Sustaeta María-Tomé, Daniel Carnevali-Ruiz
Background: The COVID-19 outbreak challenges the Spanish health system since March 2020. Some available therapies (antimalarials, antivirals, biological agents) were grounded on clinical case observations or basic science data. The aim of this study is to describe the characteristics and impact of different therapies on clinical outcomes in a cohort of severe COVID-19 patients. Methods: In this retrospective, single-center, observational study, we collected sequential data on adult patients admitted to Hospital Universitario Quironsalud Madrid...
October 15, 2020: EClinicalMedicine
W Reid Thompson, Brittany Hornby, Ryan Manuel, Elena Bradley, Janice Laux, Jim Carr, Hilary J Vernon
PURPOSE: To evaluate effectiveness of elamipretide in Barth syndrome (BTHS), a genetic condition of defects in TAZ, which causes abnormal cardiolipin on the inner mitochondrial membrane. METHODS: We performed a randomized, double-blind, placebo-controlled crossover trial followed by an open-label extension in BTHS to test the effect of elamipretide, a mitochondrial tetrapeptide that interacts with cardiolipin. In part 1, 12 subjects were randomized to 40 mg per day of elamipretide or placebo for 12 weeks, followed by a 4-week washout and then 12 weeks on the opposite arm...
October 20, 2020: Genetics in Medicine: Official Journal of the American College of Medical Genetics
Ariane Volkmann, Anna-Lise Williamson, Heinz Weidenthaler, Thomas P H Meyer, James S Robertson, Jean-Louis Excler, Richard C Condit, Eric Evans, Emily R Smith, Denny Kim, Robert T Chen
The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) was formed to evaluate the safety and characteristics of live, recombinant viral vector vaccines. The Modified Vaccinia Ankara (MVA) vector system is being explored as a platform for development of multiple vaccines. This paper reviews the molecular and biological features specifically of the MVA-BN vector system, followed by a template with details on the safety and characteristics of an MVA-BN based vaccine against Zaire ebolavirus and other filovirus strains...
October 17, 2020: Vaccine
Ellis Niemantsverdriet, Yousra J Dakkak, Leonie E Burgers, Femke Bonte-Mineur, Gerda M Steup-Beekman, Sjoerd M van der Kooij, Hido D Boom, Cornelia F Allaart, Pascal H P de Jong, Annette H M van der Helm-van Mil
BACKGROUND: We present a study protocol for a randomized, double-blind, placebo-controlled trial that investigates the hypothesis if intervention in the symptomatic phase preceding clinical arthritis (clinically suspect arthralgia (CSA)) is effective in preventing progression from subclinical inflammation to clinically apparent persistent arthritis. Currently, rheumatoid arthritis (RA) can be recognized and diagnosed when arthritis (joint swelling) has become detectable at physical examination...
October 16, 2020: Trials
Michael Najfeld, Robert Hube, Ann-Kathrin Kujat, Hermann Otto Mayr, Kathi Thiele
PURPOSE: In recent years, there has been an increasing interest in local infiltration analgesia (LIA) as a technique to control postoperative pain. We compared this technique to the gold standard the 3 in 1 femoral nerve block (FNB) in postoperative pain management after total knee arthroplasty (TKA) in a large patient population. This trial analyzes in the early postoperative phase the pain, range of motion, and consumption of pain medications after TKA. METHODS: We conducted a retrospective trial that included all patients who were undergoing primary TKA by one single surgeon in a high-volume arthroplasty center in 2015...
October 19, 2020: Journal of Orthopaedic Surgery and Research
Ian Chau, Nicolas Penel, Andres O Soriano, Hendrik-Tobias Arkenau, Jennifer Cultrera, Rafael Santana-Davila, Emiliano Calvo, Christophe Le Tourneau, Lars Zender, Johanna C Bendell, Gu Mi, Ling Gao, Samuel Clark McNeely, Joana M Oliveira, David Ferry, Roy S Herbst, Charles S Fuchs
Ramucirumab (anti-VEGFR2) plus pembrolizumab (anti-PD1) demonstrated promising antitumor activity and tolerability among patients with previously treated advanced cancers, supporting growing evidence that combination therapies modulating the tumor microenvironment may expand the spectrum of patients who respond to checkpoint inhibitors. Here we present the results of this combination in first-line patients with metastatic G/GEJ cancer. Twenty-eight patients (≥18 years) with no prior systemic chemotherapy in the advanced/metastatic setting received ramucirumab (8 mg/kg days 1 and 8) plus pembrolizumab (200 mg day 1) every 3 weeks as part of JVDF phase 1a/b study...
October 15, 2020: Cancers
Jason Yap, Daniel Slade, Harriet Goddard, Christopher Dawson, Raji Ganesan, Shireen Velangi, Banchhita Sahu, Baljit Kaur, Ana Hughes, David Luesley
OBJECTIVE: To compare the safety and efficacy of 10% sinecatechins (Veregen®) ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN). DESIGN: A Phase II double-blind randomised control trial. SETTING: A tertiary gynaecological oncology referral center. POPULATION: All women diagnosed with primary and recurrent uVIN. METHODS: Eligible patients were randomised 1:1 to receive either sinecatechins or placebo ointment (applied 3 times daily for 16 weeks), and were followed up at 2, 4, 8, 16, 32 and 52 weeks...
October 19, 2020: BJOG: An International Journal of Obstetrics and Gynaecology
Josephine van de Maat, Michaël van der Ven, Gertjan Driessen, Anne-Marie van Wermeskerken, Frank Smit, Jeroen Noordzij, Gerdien Tramper-Stranders, Charlie Obihara, Jeanine Punt, Henriette Moll, Suzanne Polinder, Rianne Oostenbrink
BACKGROUND: Children with fever and respiratory symptoms represent a large patient group at the emergency department (ED). A decision rule-based treatment strategy improved targeting of antibiotics in these children in a recent clinical trial. This study aims to evaluate the impact of the decision rule on healthcare and societal costs, and to describe costs of children with suspected lower respiratory tract infections (RTIs) in the ED in general. METHODS: In a stepped-wedge, cluster randomized trial, we collected cost data of children 1 month to 5 years of age with fever and cough/dyspnea in 8 EDs in The Netherlands (2016-2018)...
November 2020: Pediatric Infectious Disease Journal
Jerome L Fleg, Steven J Keteyian, Pamela N Peterson, Roberto Benzo, Joseph Finkelstein, Daniel E Forman, Diann E Gaalema, Lawton S Cooper, Antonello Punturieri, Lyndon Joseph, Susan Shero, Susan Zieman
Although both cardiac rehabilitation (CR) and pulmonary rehabilitation (PR) are recommended by clinical practice guidelines and covered by most insurers, they remain severely underutilized. To address this problem, the National Heart, Lung, and Blood Institute (NHLBI), in collaboration with the National Institute on Aging (NIA), developed Funding Opportunity Announcements (FOAs) in late 2017 to support phase II clinical trials to increase the uptake of CR and PR in traditional and community settings. The objectives of these FOAs were to (1) test strategies that will lead to increased use of CR and PR in the US population who are eligible based on clinical guidelines; (2) test strategies to reduce disparities in the use of CR and PR based on age, gender, race/ethnicity, and socioeconomic status; and (3) test whether increased use of CR and PR, whether by traditional center-based or new models, is accompanied by improvements in relevant clinical and patient-centered outcomes, including exercise capacity, cardiovascular and pulmonary risk factors, and quality of life...
October 15, 2020: Journal of Cardiopulmonary Rehabilitation and Prevention
Judith M Resick, Caroline Sefcik, Robert M Arnold, Thomas W LeBlanc, Marie Bakitas, Margaret Quinn Rosenzweig, Thomas J Smith, Kathleen A Dorritie, Alison Sehgal, Annie Im, Rose Folino, Nicole Tarr, David Bress, Yael Schenker
Objective: Develop and pilot-test a nurse-led primary palliative care intervention for patients with advanced hematologic malignancies. Background: Nurse-led primary palliative care interventions may improve outpatient palliative care provision for patients with advanced hematologic malignancies. Methods: This two-phase, single-arm pilot study involved patients with recurrent or resistant hematologic malignancies, their caregivers, and oncology clinicians at two US-based urban, university-affiliated oncology clinics...
October 19, 2020: Journal of Palliative Medicine
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