210,452 results match your criteria efficacy safety


Safety of cyclin-dependent kinase4/6 inhibitor combined with palliative radiotherapy in patients with metastatic breast cancer.

Breast 2021 Oct 9;60:163-167. Epub 2021 Oct 9.

Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. Electronic address:

Introduction: Cyclin-dependent kinase (CDK)4/6 inhibitor is a first-line therapy for metastatic ER+/HER2-breast cancer. However, there are limited data on safety of combined radiotherapy (RT) and CDK4/6 inhibition.

Methods: We conducted a retrospective study of women with metastatic breast cancer who received palliative RT within 14 days of CDK4/6 inhibitor use. Read More

View Article and Full-Text PDF
October 2021

Impact of allogeneic feline uterine-derived mesenchymal stromal cell intravenous treatment on renal function of nephrectomized cats with chronic kidney disease.

Res Vet Sci 2021 Sep 30;141:33-41. Epub 2021 Sep 30.

Gallant, 10865 Road to the Cure, Ste. 101, San Diego, CA 92121, USA. Electronic address:

Chronic kidney disease (CKD) is a common condition and leading cause of mortality in cats. Mesenchymal stromal cells (MSCs) may have a therapeutic effect on CKD. The aim of this pilot study was to determine efficacy of systemically-administered allogeneic uterine tissue-derived MSCs (UMSCs) in cats with CKD. Read More

View Article and Full-Text PDF
September 2021

Radiological and clinical outcomes of stereotactic radiosurgery for intraventricular metastases.

World Neurosurg 2021 Oct 12. Epub 2021 Oct 12.

Department of Neurological Surgery, University of Virginia, Charlottesville, Virginia, USA. Electronic address:

Objective: The optimal management of intraventricular metastases remains debatable. The aim of this study is to define the safety and efficacy of Gamma-Knife radiosurgery in the treatment of intraventricular metastases.

Methods: This retrospective, single-center study involved patients that were treated with stereotactic radiosurgery (SRS) for intraventricular metastases. Read More

View Article and Full-Text PDF
October 2021

Clinical Complete Response in Patients with Rectal Adenocarcinoma Treated with Short-Course Radiation Therapy and Nonoperative Management.

Int J Radiat Oncol Biol Phys 2021 Oct 12. Epub 2021 Oct 12.

Department of Radiation Oncology, Washington University School of Medicine, Saint Louis, Missouri, USA. Electronic address:

Purpose: This study aimed to determine the clinical efficacy and safety of nonoperative management (NOM) for patients with rectal cancer with a clinical complete response (cCR) after short-course radiation therapy (SCRT) and consolidation chemotherapy.

Methods And Materials: Patients with Stage I-III rectal adenocarcinoma underwent SCRT followed by consolidation chemotherapy between 01/2018 and 05/2019 (n=90). Clinical response was assessed by digital rectal examination, pelvic magnetic resonance imaging (MRI), and endoscopy. Read More

View Article and Full-Text PDF
October 2021

Thermoresponsive polymeric dexamethasone prodrug for arthritis pain.

J Control Release 2021 Oct 12. Epub 2021 Oct 12.

Department of Pharmaceutical Sciences, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE 68198, USA; Ensign Pharmaceutical, Inc., Omaha, NE 68106, USA; Department of Orthopaedic Surgery and Rehabilitation, University of Nebraska Medical Center, Omaha, NE 68198, USA. Electronic address:

Intra-articular (IA) glucocorticoids (GC) are commonly used for clinical management of both osteoarthritis and rheumatoid arthritis, but their efficacy is limited by the relatively short duration of action and associated side effects. To provide sustained efficacy and to improve the safety of GCs, we previously developed a N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer-based dexamethasone (Dex) prodrug. Serendipitously, we discovered that, by increasing the Dex content of the prodrug to unusually high levels, the aqueous solution of the polymeric prodrug becomes thermoresponsive, transitioning from a free-flowing liquid at 4 °C to a hydrogel at 30 °C or greater. Read More

View Article and Full-Text PDF
October 2021

Efficacy and safety of split-dose bowel preparation with 1 L polyethylene glycol and ascorbate compared with 2 L polyethylene glycol and ascorbate in a Korean population: a phase 4, multicenter, randomized, endoscopist-blinded study.

Gastrointest Endosc 2021 Oct 12. Epub 2021 Oct 12.

Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea. Electronic address:

Background And Aims: The 1-L PEG-based bowel preparation agent NER1006 (Plenvu) has shown high cleansing efficacy and tolerability in clinical trials in Europe and North America. However, no clinical trials have been reported yet in Asia. Therefore, the aim of this study was to evaluate the efficacy and safety of 1L PEG-based bowel preparation with Plenvu compared with 2L PEG plus ascorbate bowel preparation in a Korean population. Read More

View Article and Full-Text PDF
October 2021

Non-inferiority of liquid thyroxine in comparison to tablets formulation in the treatment of children with congenital hypothyroidism.

J Pediatr Endocrinol Metab 2021 Oct 18. Epub 2021 Oct 18.

Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics Medical School, National and Kapodistrian University of Athens, "Aghia Sophia" Children's Hospital, Athens, Greece.

Objectives: The aim of the current prospective randomized control study was to assess efficacy, safety, and non-inferiority of a new liquid L-thyroxine formulation dissolved in glycerol and water (T4 drops, produced by a Greek pharmaceutical Company, Uni-Pharma, Athens, Greece) in comparison to the standard Tablets form (T4 tablets, Uni-Pharma, Athens, Greece) in the substitutive treatment of children with congenital hypothyroidism (CH).

Methods: Thirty-nine children with CH, aged 3-12 years old, were enrolled in the study, after parental Informed Consent has been obtained, while three patients were lost from follow-up. At baseline, all participants had normal thyroid-stimulating hormone (TSH) and Free T4 values. Read More

View Article and Full-Text PDF
October 2021

Efficacy and Safety of Ferric Carboxymaltose Infusion in Reducing Anemia in Patients Receiving Chemotherapy for Nonmyeloid Malignancies: a Randomized, Placebo-Controlled Study (IRON CLAD).

Am J Hematol 2021 Oct 15. Epub 2021 Oct 15.

Huntsman Cancer Institute, Salt Lake City, UT, USA.

Purpose: Erythropoiesis-stimulating agents (ESA) are effective for chemotherapy-induced anemia (CIA) but associated with serious adverse events. Safer alternatives would be beneficial in this population. The efficacy and safety of ferric carboxymaltose (FCM) as monotherapy for CIA was evaluated. Read More

View Article and Full-Text PDF
October 2021

Besifovir therapy improves hepatic histology and reduces covalently closed circular DNA in chronic hepatitis B patients.

J Gastroenterol Hepatol 2021 Oct 15. Epub 2021 Oct 15.

Department of Precision Medicine, Sungkyunkwan University, School of Medicine, Suwon, Republic of Korea.

Background/aims: Besifovir dipivoxil maleate (BSV) was reported to have comparable antiviral efficacy and superior renal and bone safety to tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB) patients. The present study aims to evaluate changes of liver histology and intrahepatic covalently closed circular DNA (cccDNA) levels by BSV treatment in comparison with TDF therapy.

Methods: This is a subset study of the phase 3 trial comparing BSV with TDF. Read More

View Article and Full-Text PDF
October 2021

Crinecerfont Lowers Elevated Hormone Markers in Adults with 21-Hydroxylase Deficiency Congenital Adrenal Hyperplasia.

J Clin Endocrinol Metab 2021 Oct 15. Epub 2021 Oct 15.

Neurocrine Biosciences, Inc.; El Camino Real, San Diego, CA.

Context: Classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency (21OHD) is characterized by impaired cortisol synthesis and excess androgen production. Corticotropin-releasing factor type 1 receptor (CRF1R) antagonism may decrease adrenal androgen production.

Objective: To evaluate the safety, tolerability, and efficacy of crinecerfont (NBI-74788), a selective CRF1R antagonist, in 21OHD. Read More

View Article and Full-Text PDF
October 2021

United States Military Implantable Collamer Lens Surgical Outcomes: An 11 Year Retrospective Review.

J Cataract Refract Surg 2021 Sep 20. Epub 2021 Sep 20.

Department of Ophthalmology, Womack Army Medical Center, Fort Bragg, NC, USA Department of Clinical Investigation, Womack Army Medical Center, Fort Bragg, NC, USA.

Purpose: To examine the long-term efficacy and safety of myopic implantable collamer lens (ICL) implantation in active duty US military personnel.

Setting: Hospital practice.

Design: Retrospective longitudinal observational study. Read More

View Article and Full-Text PDF
September 2021

Switching from efavirenz to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide reduces central nervous system symptoms in people living with HIV.

Chin Med J (Engl) 2021 Oct 13. Epub 2021 Oct 13.

Department of Infectious Diseases, Tianjin Second People's Hospital, Tianjin 300192, China Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.

Background: Central nervous system (CNS) symptoms after efavirenz (EFV) treatment in people living with human immunodeficiency virus (HIV) could persist and impact their quality of life. We assessed the impact of EFV-based regimen replacement with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), which is considered an alternative option for subjects who do not tolerate EFV. Most specifically, we assessed the safety and the efficacy of E/C/F/TAF and its effects on the participants' neuropsychiatric toxicity symptoms in a real-life setting. Read More

View Article and Full-Text PDF
October 2021

Efficacy and Safety of Probiotic Use in Preterm Infants Remains Unproven.

Authors:
Judy A Beal

MCN Am J Matern Child Nurs 2021 Nov-Dec 01;46(6):361

Dr. Judy A. Beal is a Professor and Dean Emerita, Simmons University, Boston, MA. Dr. Beal can be reached via email at

View Article and Full-Text PDF
October 2021

The Role of Traditional Chinese Medicine in COVID-19: Theory, Initial Clinical Evidence, Potential Mechanisms, and Implications.

Altern Ther Health Med 2021 Oct 15. Epub 2021 Oct 15.

Background: Traditional Chinese Medicine (TCM) has played a significant role in combating coronavirus disease 2019 (COVID-19) in China. However, our understanding of the efficacy and mechanisms of TCM in treating COVID-19 remains limited. Thus, it is important to stimulate further discussion based on early empirical evidence. Read More

View Article and Full-Text PDF
October 2021

Advances in Breast Cancer Radiotherapy: Implications for Current and Future Practice.

JCO Oncol Pract 2021 Oct 15:OP2100635. Epub 2021 Oct 15.

GenesisCare, Farmington Hills, MI.

Radiation therapy (RT) is an essential component in the management of breast cancer. Following breast-conserving surgery (BCS), adjuvant RT is the standard of care for most patients. Traditionally, RT was delivered with standard whole breast irradiation (WBI) over 5-7 weeks following BCS. Read More

View Article and Full-Text PDF
October 2021

Sorbitol is a severity biomarker for PMM2-CDG with therapeutic implications.

Ann Neurol 2021 Oct 15. Epub 2021 Oct 15.

Department of Clinical Genomics, Mayo Clinic, Rochester, MN, 55905, USA.

Objective: Epalrestat, an aldose reductase inhibitor increases PMM enzyme activity in a PMM2-CDG worm-model. Epalrestat also decreases sorbitol level in diabetic neuropathy. We evaluated the genetic, biochemical and clinical characteristics including the Nijmegen Progression CDG Rating Scale, urine polyol levels and fibroblast glycoproteomics in PMM2-CDG patients. Read More

View Article and Full-Text PDF
October 2021

Long-Term Safety of Risankizumab From 17 Clinical Trials in Patients With Moderate-to-Severe Plaque Psoriasis.

Br J Dermatol 2021 Oct 15. Epub 2021 Oct 15.

Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Background: Risankizumab has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis in randomized clinical trials.

Objectives: We evaluated safety data from risankizumab psoriasis phase 1-3 clinical trials.

Methods: Short-term safety (through week 16) was analyzed using integrated data from five phase 2 and 3 clinical trials; long-term safety was evaluated using integrated data from 17 phase 1-3 completed and ongoing trials. Read More

View Article and Full-Text PDF
October 2021

Real-world results of direct-acting antivirals use for the treatment of chronic hepatitis C in old patients.

Eur Geriatr Med 2019 Apr 24;10(2):295-302. Epub 2019 Jan 24.

Internal Medicine Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Background And Aim: Old people with chronic hepatitis C (HCV) were considered a difficult-to-treat category with more frequent adverse events until recently. Interferon-free direct-acting antivirals (DAAs) improved treatment adherence and quality of life of old patients. In this study, we aimed at reporting the real-world efficacy and safety of DAAs, in addition to predictors of sustained virological response (SVR) in old chronic HCV population. Read More

View Article and Full-Text PDF

Cardiac Effects of Phosphodiesterase-5 Inhibitors: Efficacy and Safety.

Cardiovasc Drugs Ther 2021 Oct 15. Epub 2021 Oct 15.

Pauley Heart Center, Virginia Commonwealth University Medical Center, McGuire VAMC, 1201 Broad Rock Boulevard, 111J, Richmond, VA, 23249, USA.

The coexistence of cardiovascular disease and erectile dysfunction is widespread, possibly owing to underlying endothelial dysfunction in both diseases. Millions of patients with cardiovascular disease are prescribed phosphodiesterase-5 (PDE5) inhibitors for the management of erectile dysfunction. Although the role of PDE5 inhibitors in erectile dysfunction therapy is well established, their effects on the cardiovascular system are unclear. Read More

View Article and Full-Text PDF
October 2021

Population pharmacogenomics: an update on ethnogeographic differences and opportunities for precision public health.

Hum Genet 2021 Oct 15. Epub 2021 Oct 15.

Department of Physiology and Pharmacology, Karolinska Institutet, 171 77, Stockholm, Sweden.

Both safety and efficacy of medical treatment can vary depending on the ethnogeographic background of the patient. One of the reasons underlying this variability is differences in pharmacogenetic polymorphisms in genes involved in drug disposition, as well as in drug targets. Knowledge and appreciation of these differences is thus essential to optimize population-stratified care. Read More

View Article and Full-Text PDF
October 2021

12-Month Outcomes of Combined Phacoemulsification and iStent Inject in Asian Eyes with Normal Tension Glaucoma: A Single-Centre Experience.

Int Ophthalmol 2021 Oct 15. Epub 2021 Oct 15.

Department of Ophthalmology, Tan Tock Seng Hospital, National Healthcare Group Eye Institute, Singapore, Singapore.

Purpose: To evaluate efficacy and safety of the iStent inject combined with phacoemulsification in Asian eyes with normal-tension glaucoma (NTG) up to 12 months after surgery.

Study Design: Retrospective case series.

Methods: Retrospective case series of eyes undergoing surgery from April 2017 to August 2019. Read More

View Article and Full-Text PDF
October 2021

Solid Oral Dosage Forms Use in Adults with Neurological Disorders and Swallowing Difficulties: A Scoping Review.

Dysphagia 2021 Oct 15. Epub 2021 Oct 15.

Pharmacy Department, Federal University of Paraná, Avenida Prefeito Lothário Meissner, 632, Jardim Botânico, Curitiba-PR, 80210-170, Brazil.

Swallowing difficulties affects the deglutition of solid oral dosage forms (SODFs) and it is a common problem among neurological disorders. Interventions may improve the use of SODFs in healthcare settings. The aim of this study was to map the available research about the interventions aiming the effective and safe use of SODFs in adults with neurological disorders and swallowing difficulties and to identify potential literature gaps in this scientific field. Read More

View Article and Full-Text PDF
October 2021

Lead fixation mechanism impacts outcome of transvenous lead extraction: Data from the European Lead Extraction ConTRolled Registry.

Europace 2021 Oct 15. Epub 2021 Oct 15.

Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Faculty of Medicine Hebrew University, 12 Shmuel Beit Street, Jerusalem 9103102, Israel.

Aims: The aims of this study is to characterize the transvenous lead extraction (TLE) population with active (A) compared with passive fixation (PFix) leads and to compare the safety, efficacy, and ease of extracting active fixation (AFix) compared with PFix right atrial (RA) and right ventricular (RV) leads.

Methods And Results: The European Lead Extraction ConTRolled Registry (ELECTRa) was analysed. Patients were divided into three groups; those with only AFix, only PFix, and combined Fix leads. Read More

View Article and Full-Text PDF
October 2021

[Efficacy and safety of empirical treatment with piperacillin/tazobactan as monotherapy in episodes of neutropenia and fever in children with cancer: systematic review and meta-analysis].

Rev Chilena Infectol 2021 Aug;38(4):488-494

Facultad de Medicina y Ciencias de la Salud, Universidad Abierta Interamericana, Argentina.

Background: Febrile neutropenia in children with onco-hematological diseases is an important cause of morbidity and mortality and requires early and adequate empirical treatment. This systematic review was conducted to evaluate if piperacillin/ tazobactan (PTZ) monotherapy leads to a lower incidence of therapeutic failures than comparators.

Methods: A literature search was carried out in Embase, and MEDLINE databases using the search terms ('febrile neutropenia' OR hemato oncology OR haemato oncology OR 'immunocompromised host' OR 'immunocompromised patient' OR 'chemotherapy-induced febrile neutropenia') AND (piperacillin OR tazobactam OR 'piperacillin plus tazobactam' OR 'piperacillin/tazobactam' OR 'piperacillin-tazobactam' OR tazocin OR 'piperacillin-tazobactam drug combination')), Efficacy endpoint was treatment failure rate. Read More

View Article and Full-Text PDF

Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression: pOLAR month 12 results.

AIDS 2021 Oct 13. Epub 2021 Oct 13.

Men's Health Foundation, Los Angeles, California Broward Health Medical Center, Fort Lauderdale, Florida Augusta University Medical Center, Augusta, Georgia Triple O Research Institute PA, West Palm Beach, Florida Wellness Center UMC of Southern Nevada, Las Vegas, Nevada Central Texas Clinical Research, Austin, Texas Long Beach Education and Research Consultants, Long Beach, California Brii Biosciences, Durham ViiV Healthcare, Research Triangle Park, North Carolina GlaxoSmithKline, Upper Providence, Pennsylvania, USA GlaxoSmithKline, Mississauga, Ontario, Canada ViiV Healthcare, Tres Cantos, Spain Janssen Research & Development, Beerse, Belgium.

Objectives: Long-acting formulations of cabotegravir (CAB) and rilpivirine (RPV) have demonstrated efficacy in Phase 3 studies. POLAR (NCT03639311) assessed antiviral activity and safety of CAB+RPV long-acting administered every 2 months (Q2 M) in adults living with HIV-1 who previously received daily oral CAB+RPV in LATTE (NCT01641809).

Design: A phase 2b, multicenter, open-label, rollover study. Read More

View Article and Full-Text PDF
October 2021

Subcellular Dynamic Immunopatterning of Cytosolic Protein Complexes on Microstructured Polymer Substrates.

ACS Sens 2021 Oct 15. Epub 2021 Oct 15.

University of Applied Sciences Upper Austria, School of Engineering, 4600 Wels, Austria.

Analysis of protein-protein interactions in living cells by protein micropatterning is currently limited to the spatial arrangement of transmembrane proteins and their corresponding downstream molecules. Here, we present a robust and straightforward method for dynamic immunopatterning of cytosolic protein complexes by use of an artificial transmembrane bait construct in combination with microstructured antibody arrays on cyclic olefin polymer substrates. As a proof, the method was used to characterize Grb2-mediated signaling pathways downstream of the epidermal growth factor receptor (EGFR). Read More

View Article and Full-Text PDF
October 2021

The challenge of detecting adverse events in adults with autism spectrum disorder who have intellectual disability.

Autism Res 2021 Oct 15. Epub 2021 Oct 15.

Clinical Pharmacology, Paediatrics and Organic Chemistry Department, Miguel Hernández University of Elche (UMH), Alicante, Spain.

Adults with autism spectrum disorder (ASD) and associated intellectual disability (ID) take a high number of different psychotropic drugs simultaneously. Nowadays, little is known about this multidrug pattern efficacy and safety. The present study has endeavored to fill this gap creating a local pharmacovigilance system. Read More

View Article and Full-Text PDF
October 2021

Safety and Pharmacokinetics of Once-Daily Multiple-Dose Administration of Islatravir in Adults Without HIV.

J Acquir Immune Defic Syndr 2021 Nov;88(3):314-321

Merck & Co, Inc, Kenilworth, NJ; and.

Background: Islatravir (MK-8591) is a novel nucleoside analog in development for the treatment and prevention of HIV-1 infection. Islatravir has potent antiviral activity and a long intracellular half-life.

Setting: A 3-panel, randomized, double-blind, placebo-controlled, multiple-dose study in 36 adults without HIV evaluated the safety, tolerability, and pharmacokinetics of islatravir after daily administration. Read More

View Article and Full-Text PDF
November 2021

Tackling metastatic triple-negative breast cancer with sacituzumab govitecan.

Expert Rev Anticancer Ther 2021 Oct 15. Epub 2021 Oct 15.

Division of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.

IntroductionMetastatic triple-negative breast cancer (TNBC) is an aggressive cancer with poor survival that is difficult to treat due to a lack of targeted options. Conventional therapies targeting hormone receptors (HR) and human epidermal growth factor 2 (HER2) are ineffective and often chemotherapy is standard-of-care. Sacituzumab govitecan (IMMU-132) is an antibody drug conjugate (ADC) comprised of an active metabolite of irinotecan, SN-38, bound to a humanized monoclonal antibody which targets trophoblastic cell-surface antigen 2 (Trop-2). Read More

View Article and Full-Text PDF
October 2021

Regulatory utility of pharmacometrics in the development and evaluation of antimicrobial agents and its recent progress in China.

CPT Pharmacometrics Syst Pharmacol 2021 Oct 15. Epub 2021 Oct 15.

Institute of Antibiotics, Huashan Hospital Affiliated to Fudan University, Shanghai, China.

Pharmacometrics is an emerging science that interprets drug, disease, and trial information in a mathematical fashion to inform and facilitate efficient drug development and/or regulatory decisions. Pharmacometrics study is increasingly adopted in the regulatory review of new antimicrobial agents. We summarized the 31 antimicrobial agents approved by the US Food and Drug Administration (FDA) and the 26 antimicrobial agents approved by European Medicines Agency (EMA) from January 2001 to May 2019. Read More

View Article and Full-Text PDF
October 2021