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Theranostic AGuIX nanoparticles as radiosensitizer: A phase I, dose-escalation study in patients with multiple brain metastases (NANO-RAD trial).

Radiother Oncol 2021 May 4. Epub 2021 May 4.

Radiotherapy Department, Grenoble Alps University Hospital, Grenoble, France.

Background And Purpose: Brain metastasis impacts greatly on patients' quality of life and survival. The phase I NANO-RAD trial assessed the safety and maximum tolerated dose of systemic administration of a novel gadolinium-based nanoparticle, AGuIX, in combination with whole brain radiotherapy in patients with multiple brain metastases not suitable for stereotactic radiotherapy.

Materials And Methods: Patients with measurable brain metastases received escalating doses of AGuIX nanoparticles (15, 30, 50, 75, or 100 mg/kg intravenously) on the day of initiation of WBRT (30 Gy in 10 fractions) in 5 cohorts of 3 patients each. Read More

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Real-World Data from Turkey: Is Sofosbuvir/Ledipasvir With or Without Ribavirin Treatment for Chronic Hepatitis C Really Effective?

Turk J Gastroenterol 2021 Feb;32(2):155-163

Department of Infectious Diseases and Clinical Microbiology, Kütahya Health Sciences University Faculty of Medicine, Kütahya, Turkey.

Background: In this study, we aimed to investigate the efficacy and safety of sofosbuvir-based therapies in the treatment of chronic hepatitis C in real-world clinical practice.

Methods: Data from patients with chronic hepatitis C treated with SOF/LDV ± RBV or SOF/RBV in 31 centers across Turkey between April 1, 2017, and August 31, 2018, were recorded in a nationwide database among infectious disease specialists. Demographics, clinical, and virological outcomes were analyzed. Read More

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February 2021

White and Red Sorghum as Primary Carbohydrate Sources in Extruded Diets of Felines.

Front Vet Sci 2021 20;8:668255. Epub 2021 Apr 20.

Department of Animal Sciences, University of Illinois at Urbana-Champaign, Urbana, IL, United States.

The research objectives were to evaluate the effect of dietary supplementation of white () and red () sorghum grains on gastrointestinal health of felines through the determination of apparent total tract macronutrient digestibility (), fecal characteristics, fermentative end-products, and microbiota, compared with a traditional corn-based diet. We hypothesize that inclusion of RSH and WSH, respectively, would be well-accepted by cats, and the RSH and WSH diets would be comparable to corn when added as the main carbohydrate source in extruded diets. Three diets containing 30% corn, 30% WSH, or 30% RSH were formulated to meet or exceed the AAFCO (2018) nutrient profiles for cats during growth. Read More

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Integrase-derived peptides together with CD24-targeted lentiviral particles inhibit the growth of CD24 expressing cancer cells.

Oncogene 2021 May 6. Epub 2021 May 6.

Health Promotion Center and Integrated Cancer Prevention Center, Sourasky Medical Center, Tel-Aviv, Israel.

The integration of viral DNA into the host genome is mediated by viral integrase, resulting in the accumulation of double-strand breaks. Integrase-derived peptides (INS and INR) increase the number of integration events, leading to escalated genomic instability that induces apoptosis. CD24 is a surface protein expressed mostly in cancer cells and is very rarely found in normal cells. Read More

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Infant formula containing bovine milk-derived oligosaccharides supports age-appropriate growth and improves stooling pattern.

Pediatr Res 2021 May 6. Epub 2021 May 6.

Nestlé Product Technology Center - Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland.

Background: Adding bovine milk-derived oligosaccharides (MOS) enhances the oligosaccharide profile of infant formula. This study aimed to evaluate the safety and efficacy of a MOS-supplemented infant formula.

Methods: In this double-blind randomized controlled trial, healthy infants 21-26 days old were either assigned to bovine milk-based, alpha-lactalbumin, and sn-2 palmitate enriched infant formula (control, n = 115) or the same formula with 7. Read More

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ACR Appropriateness Criteria® Radiologic Management of Lower Gastrointestinal Tract Bleeding: 2021 Update.

J Am Coll Radiol 2021 May;18(5S):S139-S152

Specialty Chair, University of Chicago Hospital, Chicago, Illinois.

Diverticulosis remains the commonest cause for acute lower gastrointestinal tract bleeding (GIB). Conservative management is initially sufficient for most patients, followed by elective diagnostic tests. However, if acute lower GIB persists, it can be investigated with colonoscopy, CT angiography (CTA), or red blood cell (RBC) scan. Read More

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First-line liposomal irinotecan with oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) in pancreatic ductal adenocarcinoma: A phase I/II study.

Eur J Cancer 2021 May 3;151:14-24. Epub 2021 May 3.

St John of God Subiaco Hospital, Subiaco, WA, Australia.

Background: This open-label, phase I/II study evaluated safety and efficacy for first-line liposomal irinotecan + oxaliplatin + 5-fluorouracil + leucovorin (NALIRIFOX).

Methods: Patients (aged ≥18 years) had locally advanced/metastatic pancreatic ductal adenocarcinoma (mPDAC), with an Eastern Cooperative Oncology Group performance status score of 0/1 and adequate organ function. Primary objectives were to determine the maximum tolerated dose (MTD) and to evaluate safety and tolerability. Read More

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Phase 2, Randomized, Placebo-Controlled Trial of Dapirolizumab Pegol in Patients with Moderate-to-Severe Active Systemic Lupus Erythematosus.

Rheumatology (Oxford) 2021 May 6. Epub 2021 May 6.

UCB Pharma, Monheim am Rhein, Germany.

Objective: To evaluate dose-response, efficacy and safety of dapirolizumab pegol (DZP) in patients with systemic lupus erythematosus (SLE).

Methods: Adults with moderately to severely active SLE (SLEDAI-2K score ≥6 and ≥1 BILAG A or ≥ 2 BILAG B domain scores), receiving stable corticosteroid (≤40 mg/day prednisone-equivalent), antimalarial, or immunosuppressant drugs were included. Patients with stable lupus nephritis (proteinuria ≤2 g/day) not receiving high-dose corticosteroids or cyclophosphamide were permitted entry. Read More

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A phase I study of a PARP1-targeted topical fluorophore for the detection of oral cancer.

Eur J Nucl Med Mol Imaging 2021 May 5. Epub 2021 May 5.

Department of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.

Background: Visual inspection and biopsy is the current standard of care for oral cancer diagnosis, but is subject to misinterpretation and consequently to misdiagnosis. Topically applied PARPi-FL is a molecularly specific, fluorescent contrast-based approach that may fulfill the unmet need for a simple, in vivo, non-invasive, cost-effective, point-of-care method for the early diagnosis of oral cancer. Here, we present results from a phase I safety and feasibility study on fluorescent, topically applied PARPi-FL. Read More

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Uracil-tegafur vs fluorouracil as postoperative adjuvant chemotherapy in Stage II and III colon cancer: A nationwide cohort study and meta-analysis.

Medicine (Baltimore) 2021 May;100(18):e25756

School of Public Health.

Abstract: We conducted a population-based cohort study enrolling patients with Stage II and III colon cancer receiving postoperative adjuvant chemotherapy with uracil and tegafur (UFT) or fluorouracil (5-FU) from the Taiwan National Health Insurance Research Database from 2000 to 2015. The outcomes of the current study were disease-free survival (DFS) and overall survival (OS). Hazard ratios (HRs) were calculated by multivariate Cox proportional hazard regression models. Read More

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Lupus acute cardiomyopathy is highly responsive to intravenous immunoglobulin treatment: Case series and literature review.

Medicine (Baltimore) 2021 May;100(18):e25591

Department of Internal Medicine E, Meir Medical Center, Kfar Saba.

Introduction: Intravenous immunoglobulin (IVIg) is currently used with considerable success for the treatment of many autoimmune diseases, including systemic lupus erythematosus (SLE). Among its various indications, IVIg has also been found to be beneficial in myocarditis, whether or not it is associated with an autoimmune disease. Nevertheless, data regarding IVIg treatment for myocarditis/cardiomyopathy in patients with SLE are sparse. Read More

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Safety and diagnostic efficacy of gadoteridol for magnetic resonance imaging of the brain and spine in children 2 years of age and younger.

Pediatr Radiol 2021 May 5. Epub 2021 May 5.

Duke University School of Medicine, Durham, NC, USA.

Background: Neonates and young children require efficacious magnetic resonance imaging (MRI) examinations but are potentially more susceptible to the short- and long-term adverse effects of gadolinium-based contrast agents due to the immaturity of their body functions.

Objective: To evaluate the acute safety and diagnostic efficacy of gadoteridol (ProHance) for contrast-enhanced MRI of the central nervous system (CNS) in children ≤2 years of age.

Materials And Methods: One hundred twenty-five children ≤2 years old (including 57 children <6 months old) who underwent contrast-enhanced MRI of the CNS with gadoteridol at 0. Read More

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Clinical use of Jak 1 inhibitors for rheumatoid arthritis.

Peter Nash

Rheumatology (Oxford) 2021 May;60(Supplement_2):ii31-ii38

School of Medicine, Griffith University, Brisbane, Queensland, Australia.

The uptake of Jak inhibitors in the RA space has been among the most rapid in rheumatology, based on the results of comprehensive clinical trial programmes of five agents. Newer generations of Jak inhibitors, like upadacitinib and filgotinib, target Jak 1 selectively with the aim of maximizing efficacy and to improve safety. This article will review the clinical significance of evidence on: (i) Jak 1 selectivity; (ii) efficacy from the SELECT and FINCH clinical trial programmes including patient intolerant or inadequately responding to MTX (MTX-IR) and other csDMARDs patients who are bDMARD-IR) and those using monotherapy when MTX is not tolerated or contraindicated and those treated when methotrexate naive; and (iii) safety from the clinical trial programmes of these two agents will be discussed. Read More

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Comprehensive Evaluation of the Toxicity and Biosafety of Plasma Polymerized Nanoparticles.

Nanomaterials (Basel) 2021 Apr 29;11(5). Epub 2021 Apr 29.

Faculty of Health and Medicine, School of Medical Sciences, University of Sydney, Sydney, NSW 2006, Australia.

The rapid growth of nanoparticle-based therapeutics has underpinned significant developments in nanomedicine, which aim to overcome the limitations imposed by conventional therapies. Establishing the safety of new nanoparticle formulations is the first important step on the pathway to clinical translation. We have recently shown that plasma-polymerized nanoparticles (PPNs) are highly efficient nanocarriers and a viable, cost-effective alternative to conventional chemically synthesized nanoparticles. Read More

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Preclinical Assessment Addressing Intravenous Administration of a [Ga]Ga-PSMA-617 Microemulsion: Acute In Vivo Toxicity, Tolerability, PET Imaging, and Biodistribution.

Molecules 2021 Apr 30;26(9). Epub 2021 Apr 30.

Department of Science and Technology, Preclinical Drug Development Platform, North West University, Potchefstroom 2520, South Africa.

It has been herein presented that a microemulsion, known to be an effective and safe drug delivery system following intravenous administration, can be loaded with traces of [Ga]Ga-PSMA-617 without losing its properties or causing toxicity. Following tolerated IV injections the capability of the microemulsion in altering [Ga]Ga-PSMA-617 distribution was presented at 120 min post injection based on its ex vivo biodistribution results. Read More

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Efficacy and Safety of Bevacizumab Plus Erlotinib in Patients with Renal Medullary Carcinoma.

Cancers (Basel) 2021 Apr 30;13(9). Epub 2021 Apr 30.

Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.

Purpose: To assess the efficacy and safety of bevacizumab plus erlotinib in patients with RMC.

Methods: We retrospectively reviewed the records of patients with RMC treated with bevacizumab plus erlotinib at our institution.

Results: Ten patients were included in the study. Read More

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Evaluation of palliative therapy, alone or in combination with toceranib phosphate, in dogs diagnosed with metastatic or recurrent beta-cell neoplasia.

N Z Vet J 2021 May 4:1-6. Epub 2021 May 4.

Department of Animal Medicine and Surgery, School of Veterinary Medicine, Complutense University of Madrid, Madrid, Spain.

To compare survival in dogs with recurrent or metastatic insulinomas that were treated with palliative therapy, alone or in combination with toceranib phosphate and to assess tolerability of the combined therapy in dogs. Dogs diagnosed with insulinoma were retrospectively identified in the records of the Veterinary Teaching Hospital Complutense (Madrid, Spain). Diagnosis of insulinoma was based on clinical signs of hypoglycaemia, concentrations in serum of glucose <3. Read More

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Dietary fibre intake and lifestyle characteristics in relation to nausea or vomiting during pregnancy-a questionnaire-based cohort study.

J Obstet Gynaecol 2021 May 4:1-8. Epub 2021 May 4.

School of Health Sciences, Tampere Research and Innovation Center and University of Tampere, Tampere University Hospital, Tampere, Finland.

Nausea or vomiting in pregnancy (NVP) are among the commonest symptoms experienced in early pregnancy. We wanted to evaluate the association of dietary fibre intake, lifestyle characteristics and bowel function with NVP. One hundred and eighty-eight participants completed a self-administered questionnaire concerning bowel function, dietary fibre intake and lifestyle characteristics. Read More

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Clinical Efficacy of Hormonal and Nonhormonal Agents in the Treatment of Vulvovaginal Atrophy.

J Menopausal Med 2021 Apr;27(1):15-23

Department of Biostatistics, Sakarya University School of Medicine, Sakarya, Turkey.

Objectives: Symptomatic local treatment of vaginal atrophy (VA) in menopausal women includes hormonal and nonhormonal preparations. Some women may be reluctant to use vaginal estradiol preparations because of the concern for developing breast cancer and endometrial hyperplasia. Therefore, it is necessary to compare the therapeutic effectiveness of alternative vaginal drugs, such as promestriene, an estrogen agonist, and sodium hyaluronate (NaH), a nonhormonal, water-based agent. Read More

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Survival benefits of salvage surgery for primary lung cancer based on routine clinical practice.

Thorac Cancer 2021 May 4. Epub 2021 May 4.

Department of Thoracic Surgery, Mie Chuo Medical Center, Tsu, Japan.

Background: Premeditated induction chemotherapy followed by surgical resection is accepted as safe and effective. Studies on salvage surgery in patients with incompletely cured lung cancer are lacking. This study aimed to demonstrate the safety and efficacy of salvage surgery. Read More

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Role of Immunosuppressive Therapy in the Management Refractory Post-Procedural Pericarditis.

J Cardiovasc Electrophysiol 2021 May 3. Epub 2021 May 3.

Kansas City Heart Rhythm Institute, Overland Park, KS.

Background: A significant rise in epicardial based interventions over the past two decades has been associated with a proportionate rise in complications - most notably, pericarditis. Post procedural pericarditis is often particularly refractory to conventional therapies with no current consensus regarding its optimal management.

Objective: To assess the safety and efficacy of a novel immunosuppressive regimen - combination Methotrexate / Prednisone (cMtx/P) - in the management of severe refractory post-procedural pericarditis (rPPP). Read More

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IDH Inhibitors in AML-Promise and Pitfalls.

Curr Hematol Malig Rep 2021 Apr 30. Epub 2021 Apr 30.

Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health & Science University, Portland, OR, 97239, USA.

Purpose Of Review: Mutations in isocitrate dehydrogenase genes (IDH1 and IDH2) are common in acute myeloid leukemia (AML), occurring in up to 30% of AML cases. Mutations in IDH leads to abnormal epigenetic regulation in AML cells and blocks differentiation. Inhibitors of mutated IDH1 and IDH2, ivosidenib and enasidenib, respectively, were recently approved by the FDA for relapsed/refractory AML; ivosidenib is also approved for newly diagnosed AML patients not fit for standard chemotherapy. Read More

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Savolitinib ± Osimertinib in Japanese Patients with Advanced Solid Malignancies or EGFRm NSCLC: Ph1b TATTON Part C.

Target Oncol 2021 May 3;16(3):339-355. Epub 2021 May 3.

Dana-Farber Cancer Institute, Boston, MA, USA.

Background: Preliminary data suggest that combining savolitinib, a potent and highly selective MET-tyrosine kinase inhibitor (TKI), with osimertinib, a third-generation, irreversible, oral epidermal growth factor receptor-TKI (EGFR-TKI), may overcome MET-based resistance to EGFR-TKIs.

Objective: To investigate the safety and tolerability of savolitinib in Japanese patients with advanced solid malignancies.

Patients And Methods: In Part C of the phase Ib, multi-arm, open-label, multicenter TATTON study, two cohorts of Japanese adult patients were evaluated across six study centers in Japan. Read More

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Treatment with proton pump inhibitors as a cofactor in adverse reactions of patients undergoing oral food immunotherapy.

Allergol Immunopathol (Madr) 2021 1;49(3):169-172. Epub 2021 May 1.

Department of Pediatric Allergology, Severo Ochoa University Hospital, Leganés, Madrid, Spain.

Background And Objectives: Based on previous studies revealing acid-suppression medication as a risk factor for food allergy tolerance induction, we aimed to establish the importance of those findings in patients undergoing oral immunotherapy (OIT).

Materials And Methods, Results: We describe a case series of four patients who underwent milk OIT with a concomitant use of proton pump inhibitor (PPI) medication and who developed anaphylaxis after a known, previously tolerated dose of milk.

Conclusions: PPIs may act as a cofactor in patients undergoing OIT, triggering adverse reactions, irrespective of the PPI used or the dosage. Read More

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Dynamic High-density Functional Substrate Mapping Improves Outcomes in Ischaemic Ventricular Tachycardia Ablation: Sense Protocol Functional Substrate Mapping and Other Functional Mapping Techniques.

Arrhythm Electrophysiol Rev 2021 Apr;10(1):38-44

Department of Cardiac Electrophysiology, Barts Heart Centre, St Bartholomew's Hospital, London, UK.

Post-infarct-related ventricular tachycardia (VT) occurs due to reentry over surviving fibres within ventricular scar tissue. The mapping and ablation of patients in VT remains a challenge when VT is poorly tolerated and in cases in which VT is non-sustained or not inducible. Conventional substrate mapping techniques are limited by the ambiguity of substrate characterisation methods and the variety of mapping tools, which may record signals differently based on their bipolar spacing and electrode size. Read More

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Immunomodulatory activity of (oral administration of gold as electuary) in infants - A randomized controlled clinical trial.

Ayu 2019 Oct-Dec;40(4):230-236. Epub 2021 Jan 14.

Department of Kaumarabhritya, All India Institute of Ayurveda, New Delhi, India.

Background: (oral administration of gold as electuary) is a form of electuary depicted in the classics of Ayurveda under the ambit of pediatrics. A specific action on immune system has been highlighted in infants if gold is administered along with and honey for a period of 28 days.

Aim: The present trial was conducted to assess the safety and efficacy of (calcined powder), (honey) and in infants with respect to anthropometrical, hematological and immunological parameters. Read More

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January 2021

10% urea cream in senile xerosis: Clinical and instrumental evaluation.

J Cosmet Dermatol 2021 Apr;20 Suppl 1:5-8

Dermatology Clinic, University of Catania, Catania, Italy.

Background: Moisturizers represent the mainstay of treatment of xerosis and related pruritus in elderly patients.

Aim: In this study, we evaluated the efficacy and tolerability of a 10% urea cream in patients with senile xerosis.

Methods: Twenty patients affected by moderate-to-severe xerosis of the upper or lower extremities were enrolled and instructed to apply twice daily for 2 weeks a cream containing 10% urea. Read More

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Sirolimus for the treatment of kaposiform hemangioendothelioma: In a trough level-dependent way.

J Dermatol 2021 May 1. Epub 2021 May 1.

Department of Pediatric Surgery, Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.

With the accumulation of clinical practice, sirolimus is now widely viewed as an effective agent in kaposiform hemangioendothelioma (KHE) treatment using a dose based on experience. Therefore, this retrospective research aimed to provide evidence-based suggestions on the most appropriate dose and trough level of sirolimus. All unresectable KHE cases diagnosed at our center from January 2016 to December 2019 were included. Read More

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Phase 1 Clinical Trial of Losmapimod in Facioscapulohumeral Dystrophy (FSHD): Safety, Tolerability, Pharmacokinetics, and Target Engagement.

Br J Clin Pharmacol 2021 Apr 30. Epub 2021 Apr 30.

Centre for Human Drug Research (CHDR), Leiden, The Netherlands.

Aims: Evaluate safety, tolerability, pharmacokinetics (PK), and target engagement (TE) of losmapimod in blood and muscle in facioscapulohumeral dystrophy (FSHD).

Methods: This study included Part A: 10 healthy volunteers (HVs) randomized to single oral doses of losmapimod (7.5 mg then 15 mg; n=8) or placebo (both periods; n=2); Part B: 15 FSHD subjects randomized to placebo (n=3), losmapimod 7. Read More

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First-in-human PET imaging and estimated radiation dosimetry of L-[5-C]-glutamine in patients with metastatic colorectal cancer.

J Nucl Med 2021 Apr 30. Epub 2021 Apr 30.

The University of Texas MD Anderson Cancer Center, United States.

Altered metabolism is a hallmark of cancer. In addition to glucose, glutamine is an important nutrient for cellular growth and proliferation. Non-invasive imaging via positron emission tomography (PET) may help facilitate precision treatment of cancer through patient selection and monitoring of treatment response. Read More

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