1,415,289 results match your criteria clinical trials

Final efficacy and safety data, and exploratory molecular profiling from the phase III ALUR study of alectinib versus chemotherapy in crizotinib-pretreated ALK-positive non-small-cell lung cancer.

ESMO Open 2022 Jan 15;7(1):100333. Epub 2022 Jan 15.

Department of Oncology, University of Turin, Orbassano, Italy. Electronic address:

Background: At the primary data cut-off, the ALUR study demonstrated significantly improved progression-free survival (PFS) and central nervous system (CNS) objective response rate (ORR) with alectinib versus chemotherapy in pretreated, advanced anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer. We report final efficacy and safety data, and exploratory molecular profiling.

Patients And Methods: Patients who received prior platinum-doublet chemotherapy and crizotinib were randomized 2 : 1 to receive alectinib 600 mg twice daily (n = 79) or chemotherapy (pemetrexed 500 mg/m or docetaxel 75 mg/m, every 3 weeks; n = 40) until progressive disease, death or withdrawal. Read More

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January 2022

The SARS-CoV-2 mutations versus vaccine effectiveness: New opportunities to new challenges.

J Infect Public Health 2022 Jan 5;15(2):228-240. Epub 2022 Jan 5.

Department of Pharmacology & Toxicology, College of Pharmacy, University of Hail, Hail, Saudi Arabia. Electronic address:

Background: The SARS-CoV-2 coronavirus epidemic is hastening the discovery of the most efficient vaccines. The development of cost-effective vaccines seems to be the only solution to terminate this pandemic. However, the vaccines' effectiveness has been questioned due to recurrent mutations in the SARS-CoV-2 genome. Read More

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January 2022

Indirect moxibustion for the treatment of allergic rhinitis: A systematic review and meta-analysis of randomized controlled trials.

Complement Ther Med 2022 Jan 15:102804. Epub 2022 Jan 15.

Department of Acupuncture and Moxibustion, The Affiliated Hospital of Jiangxi University of TCM, Jiangxi, 330006, China. Electronic address:

Objective: To synthesize the results of randomized clinical trials (RCTs) and evaluate the effectiveness and safety of indirect moxibustion for the treatment of allergic rhinitis (AR).

Methods: PubMed, the Cochrane Library, Embase, Web of Science, CNKI, WanFang, VIP, and CBM from the establishment to May 22, 2020 were searched. This was a PRISMA review. Read More

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January 2022

Sustained Release In Situ Thermogelling Hydrogel of Cerebrolysin for Treatment of Facial Nerve Axotomy in Rats.

J Oral Maxillofac Surg 2021 Dec 23. Epub 2021 Dec 23.

Assistant Professor, Oral Biology Department, Faculty of Dentistry, Mansoura University, Egypt. Electronic address:

Purpose: The most essential principle in managing facial nerve (FN) injury is proper diagnosis and early treatment. This study evaluated local application of different concentrations and injection intervals of cerebrolysin hydrogel (CBL) for facial nerve axotomy (FNA) treatment.

Hypothesis: We hypothesized that local application of CBL may provide a sustained release of CBL and enhance neural regeneration. Read More

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December 2021

Balanced Multielectrolyte Solution versus Saline in Critically Ill Adults.

N Engl J Med 2022 Jan 18. Epub 2022 Jan 18.

From the George Institute for Global Health and the University of New South Wales (S.F., S.M., N.H., L.B., A.D., M.G., Q.L., J. Mysore, M.S., C.T., J. Myburgh), the Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital (N.H., A.D.), the Northern Clinical School (A.D.) and the Central Clinical School (D.G.), University of Sydney, the Intensive Care Unit, Royal Prince Alfred Hospital (D.G.), the Department of Intensive Care, St. George Hospital (M.S., J. Myburgh), and the Intensive Care Unit, Bankstown Hospital (M.S.), Sydney, and the Intensive Care Unit, Austin Hospital (R.B.), the Department of Intensive Care, Royal Melbourne Hospital (R.B.), the Department of Critical Care, University of Melbourne (R.B., P.Y.), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., P.Y.), Melbourne, VIC - all in Australia; the School of Public Health, Imperial College London, London (S.F.); and the Medical Research Institute of New Zealand (L.N., D.M., P.Y.) and the Department of Intensive Care, Wellington Regional Hospital (L.N., P.Y.) - both in Wellington.

Background: Whether the use of balanced multielectrolyte solution (BMES) in preference to 0.9% sodium chloride solution (saline) in critically ill patients reduces the risk of acute kidney injury or death is uncertain.

Methods: In a double-blind, randomized, controlled trial, we assigned critically ill patients to receive BMES (Plasma-Lyte 148) or saline as fluid therapy in the intensive care unit (ICU) for 90 days. Read More

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January 2022

Early structural brain development in infants exposed to HIV and antiretroviral therapy in utero in a South African birth cohort.

J Int AIDS Soc 2022 Jan;25(1):e25863

Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, University of Cape Town, Cape Town, South Africa.

Introduction: There is a growing population of children who are HIV-exposed and uninfected (HEU) with the successful expansion of antiretroviral therapy (ART) use in pregnancy. Children who are HEU are at risk of delayed neurodevelopment; however, there is limited research on early brain growth and maturation. We aimed to investigate the effects of in utero exposure to HIV/ART on brain structure of infants who are HEU compared to HIV-unexposed (HU). Read More

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January 2022

Urinary levels of pro-fibrotic transglutaminase 2 (TG2) may help predict progression of chronic kidney disease.

PLoS One 2022 18;17(1):e0262104. Epub 2022 Jan 18.

Academic Nephrology Unit and Sheffield Kidney Institute, University of Sheffield Medical School, Sheffield, United Kingdom.

Renal clinical chemistry only detects kidney dysfunction after considerable damage has occurred and is imperfect in predicting long term outcomes. Consequently, more sensitive markers of early damage and better predictors of progression are being urgently sought, to better support clinical decisions and support shorter clinical trials. Transglutaminase 2 (TG2) is strongly implicated in the fibrotic remodeling that drives chronic kidney disease (CKD). Read More

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January 2022

Pregnancy health and perinatal outcomes among Pacific Islander women in the United States and US Affiliated Pacific Islands: Protocol for a scoping review.

PLoS One 2022 18;17(1):e0262010. Epub 2022 Jan 18.

Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, CT, United States of America.

This scoping review examines the literature on pregnancy and perinatal outcomes among Pacific Islander women in the United States (U.S.) and U. Read More

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January 2022

Ultra-Low Energy Cycled Burst Spinal Cord Stimulation Yields Robust Outcomes in Pain, Function, and Affective Domains: A Subanalysis From Two Prospective, Multicenter, International Clinical Trials.

Neuromodulation 2022 Jan;25(1):137-144

University of Chicago Medical Center, Chicago, IL, USA.

Introduction: DeRidder's burst stimulation design has become a key spinal cord stimulation (SCS) waveform because it reduces the intensity of pain as well as its associated emotional distress. The brain pathways underlying these outcomes may also allow for the effects of stimulation to carry over after stimulation is turned off, making it amenable to intermittent application. Here, the utility of intermittently cycled burst was evaluated using data from two large real-world prospective studies (TRIUMPH, REALITY). Read More

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January 2022

Obstructive Sleep apnea and cardiovascular events in Elderly Patients.

Expert Rev Respir Med 2022 Jan 18. Epub 2022 Jan 18.

Department of Pulmonary, Critical Care, and Sleep Medicine. University of California, San Diego, California.

Introduction: In recent decades, life expectancy has increased considerably. The cardiovascular effects of Obstructive Sleep Apnea (OSA) in the elderly lead to patient disability and high resource consumption. Intermittent nocturnal hypoxia leads to hemodynamic stress and adrenergic activation, which promotes cardiovascular disease. Read More

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January 2022

Successful Sclerotherapy for Cervicofacial Macrocystic Lymphatic Malformations Using Polidocanol and Pingyangmycin Combined Foam Sclerosants.

Lymphat Res Biol 2022 Jan 17. Epub 2022 Jan 17.

Department of Oromaxillofacial Head and Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Sclerotherapy is the first-line therapeutic method for lymphatic malformations (LMs). This retrospective cohort study evaluated the effectiveness and safety of a novel combined foam sclerosant: polidocanol and pingyangmycin foam (PPF), for treating cervicofacial macrocystic LMs. From July 2018 to October 2020, 51 patients with cervicofacial macrocystic LMs were enrolled in this study. Read More

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January 2022

Time-of-Day and Clinical Outcomes After Surgical or Transcatheter Aortic Valve Replacement: Insights From the PARTNER Trials.

Circ Cardiovasc Qual Outcomes 2022 Jan 18;15(1):e007948. Epub 2022 Jan 18.

Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval/Québec Heart and Lung Institute, Laval University, Canada (F.V., J.T., P.P.).

Background: Circadian rhythms may influence myocardial tolerance to ischemia-reperfusion phenomena occurring during cardiac procedures. While conflicting results exist on the effect of time-of-day on surgical aortic valve replacement (SAVR), afternoon procedures could be associated with a reduced risk of death, rehospitalization or periprocedural myocardial infarction, compared with morning procedures. We examined the impact of procedure time-of-day on outcomes after transcatheter aortic valve replacement (TAVR) or SAVR. Read More

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January 2022

E-Cigarettes and Cardiopulmonary Health: Review for Clinicians.

Circulation 2022 Jan 18;145(3):219-232. Epub 2022 Jan 18.

Department of Cell Biology and Physiology, The University of North Carolina, Chapel Hill (A.G., M.F.S., R.T.).

Electronic cigarettes (e-cigarettes) are battery powered electronic nicotine delivery systems that use a propylene glycol/vegetable glycerin base to deliver vaporized nicotine and flavorings to the body. E-cigarettes became commercially available without evidence regarding their risks, long-term safety, or utility in smoking cessation. Recent clinical trials suggest that e-cigarette use with counseling may be effective in reducing cigarette use but not nicotine dependence. Read More

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January 2022

Migraine and light: A narrative review.

Headache 2022 Jan;62(1):4-10

I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.

Objective: In this narrative review, we summarize clinical and experimental data on the effect of light in migraine and discuss future prospects.

Background: Effective nonpharmacological treatment of hypersensitivity to light in migraine is an unmet clinical need. Current management strategies primarily consist of seeking a dark room and avoiding light exposure. Read More

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January 2022

New Developments in Topical Acne Therapy.

Am J Clin Dermatol 2022 Jan 18. Epub 2022 Jan 18.

Department of Dermatology, Brigham and Women's Hospital, 221 Longwood Avenue, Boston, MA, 02115, USA.

Acne vulgaris is a common chronic inflammatory disease with a multifactorial pathogenesis. Although myriad acne treatments are available, current options may not be sufficient because of a lack of efficacy, limited tolerability, or burden of cost to patients. In this review, we highlight recently approved topical acne treatments, as well as those currently in clinical trials. Read More

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January 2022

Characterization of quantitative flow ratio and fractional flow reserve discordance using doppler flow and clinical follow-up.

Int J Cardiovasc Imaging 2022 Jan 18. Epub 2022 Jan 18.

Department of Cardiology, Aarhus University Hospital, Palle Juul Jensens Boulevard 99, 8200, Aarhus N, Denmark.

The physiological mechanisms of quantitative flow ratio and fractional flow reserve disagreement are not fully understood. We aimed to characterize the coronary flow and resistance profile of intermediate stenosed epicardial coronary arteries with concordant and discordant FFR and QFR. Post-hoc analysis of the DEFINE-FLOW study. Read More

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January 2022

Real-life experience with bictegravir/emtricitabine/tenofovir alafenamide in a large reference clinical centre.

J Antimicrob Chemother 2022 Jan 18. Epub 2022 Jan 18.

HIV Unit, Infectious Disease Service, Hospital Clínic-IDIBAPS, University of Barcelona, Barcelona, Spain.

Background: The use of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is mainly based on robust, pivotal clinical trials.

Objectives: To provide data on clinical use of BIC/FTC/TAF in real life.

Patients And Methods: This was an observational, retrospective and single-centre study. Read More

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January 2022

Frequency of Adverse Events in the Placebo Arms of COVID-19 Vaccine Trials: A Systematic Review and Meta-analysis.

JAMA Netw Open 2022 Jan 4;5(1):e2143955. Epub 2022 Jan 4.

Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

Importance: Adverse events (AEs) after placebo treatment are common in randomized clinical drug trials. Systematic evidence regarding these nocebo responses in vaccine trials is important for COVID-19 vaccination worldwide especially because concern about AEs is reported to be a reason for vaccination hesitancy.

Objective: To compare the frequencies of AEs reported in the placebo groups of COVID-19 vaccine trials with those reported in the vaccine groups. Read More

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January 2022

Assessment of Long-term Psychological Outcomes After Pediatric Intensive Care Unit Admission: A Systematic Review and Meta-analysis.

JAMA Pediatr 2022 Jan 18:e215767. Epub 2022 Jan 18.

MD Programme, Duke-NUS Medical School, Singapore.

Importance: The pediatric intensive care unit (PICU) exposes children to stressful experiences with potential long-term psychological repercussions. However, current understanding of post-PICU psychological outcomes is incomplete.

Objective: To systematically review and evaluate reported long-term psychological outcomes among children previously admitted to the PICU. Read More

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January 2022

Survey for Government Policies Regarding Strategies for the Commercialization and Globalization of Digital Therapeutics.

Yonsei Med J 2022 Jan;63(Suppl):S56-S62

Department of Public Health, Yonsei University Graduate School, Seoul, Korea.

Purpose: This study was conducted to build a direction for government policies regarding strategies for the commercialization of digital therapeutics in Korea, as well as its globalization.

Materials And Methods: The study included 37 participants from the Korea Digital Health Industry Association (KODHIA). The data was based on a survey conducted in 2020 targeting employees of companies engaged in the digital health industry in Korea. Read More

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January 2022

Clinical quality registries: urgent reform is required to enable best practice and best care.

ANZ J Surg 2022 Jan 18. Epub 2022 Jan 18.

Department of Surgery, Deakin University, Barwon Health, Geelong, Victoria, Australia.

Clinical quality registries (CQRs) systematically collect data on pre-agreed markers of quality of care for a given procedure, that can be reliably and reproducibly defined and collected across multiple sites. Data is then risk adjusted, and comparisons may be used to benchmark performance. These data then inform quality improvement initiatives. Read More

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January 2022

mTOR Inhibition with Sirolimus in Multiple System Atrophy: A Randomized, Double-Blind, Placebo-Controlled Futility Trial and 1-Year Biomarker Longitudinal Analysis.

Mov Disord 2022 Jan 18. Epub 2022 Jan 18.

Department of Neurology, New York University Grossman School of Medicine, New York, New York, USA.

Background: Multiple system atrophy (MSA) is a fatal neurodegenerative disease characterized by the aggregation of α-synuclein in glia and neurons. Sirolimus (rapamycin) is an mTOR inhibitor that promotes α-synuclein autophagy and reduces its associated neurotoxicity in preclinical models.

Objective: To investigate the efficacy and safety of sirolimus in patients with MSA using a futility design. Read More

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January 2022

Antiviral, Anticancer and Hypotensive Potential of Diphyllin Glycosides and their Mechanisms of Action.

Mini Rev Med Chem 2022 Jan 17. Epub 2022 Jan 17.

Yenepoya Research Centre, Yenepoya (Deemed to be University), Deralakatte, Mangalore-575018, Karnataka, India.

Diphyllin glycosides (DG) are the type of arylnaphthalene lignans isolated from different plants and their synthetic derivatives have shown effective antiviral, cytotoxic, hypotensive and diuretic effects at very low concentrations similar to standard drugs that are under clinical use. The biological activities of the DG interfere with signaling pathways of viral infection and cancer induction. The sugar moieties of DG enhance bioavailability and pharmacological activities. Read More

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January 2022

Olanzapine/Samidorphan: New Drug Approved for Treating Bipolar I Disorder and Schizophrenia.

Ann Pharmacother 2022 Jan 18:10600280211070330. Epub 2022 Jan 18.

Departments of Pharmacotherapy & Translational Research and Community Health & Family Medicine, College of Pharmacy and Medicine, University of Florida, Gainesville, FL, USA.

Objective: To describe the approval of olanzapine/samidorphan, compare the clinical trial data, and summarize key findings, with a focus on impact to clinical practice.

Data Sources: A literature search of PubMed was performed (March 2006 to November 2021) using the following search terms: . Product monographs, review articles, and randomized control trials were reviewed. Read More

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January 2022

Towards a national perioperative outcomes registry: A survey of perioperative electronic medical record utilisation to support quality assurance and research at Australian and New Zealand College of Anaesthetists Clinical Trials Network hospitals in Australia.

Anaesth Intensive Care 2022 Jan 18:310057X211030284. Epub 2022 Jan 18.

Department of Anaesthesiology and Perioperative Medicine, Alfred Health, Melbourne, Australia.

In Australia, 2.7 million surgical procedures are performed annually. Historically, a lack of perioperative data standardisation and infrastructure has limited pooling of routinely collected data across institutions. Read More

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January 2022

Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour.

J Eval Clin Pract 2022 Jan 17. Epub 2022 Jan 17.

Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.

Background: Setting up and conducting a randomised controlled trial (RCT) has many challenges-particularly trials that include vulnerable individuals with behavioural problems or who reside in facilities that focus on care as opposed to research. These populations are underrepresented in RCTs.

Approach: In our paper, we describe the challenges and practical lessons learned from two RCTs in two care settings involving long-stay psychiatric inpatients and people with intellectual disabilities. Read More

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January 2022

Identification of polypharmacological anticancerous molecules against Aurora kinase family of proteins.

J Cell Biochem 2022 Jan 17. Epub 2022 Jan 17.

Department of Biophysics, All India Institute of Medical Sciences, New Delhi, India.

The Human Aurora Kinase (AURK) protein family is the key player of cell cycle events including spindle assembly, kinetochore formation, chromosomal segregation, centrosome separation, microtubule dynamics, and cytokinesis. Their aberrant expression has been extensively linked with chromosomal instability in addition to derangement of multiple tumor suppressors and oncoprotein regulated pathways. Therefore, the AURK family of kinases is a promising target for the treatment of various types of cancer. Read More

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January 2022

Fatty Kidney: A Possible Future for Chronic Kidney Disease Research.

Eur J Clin Invest 2022 Jan 18:e13748. Epub 2022 Jan 18.

Division of Nephrology, University of Washington, Seattle, Washington, USA.

Background: Metabolic syndrome is a growing twenty first century pandemic associated with multiple clinical comorbidities ranging from cardiovascular diseases, non-alcoholic fatty liver disease, and polycystic ovary syndrome to kidney dysfunction. A novel area of research investigates the concept of fatty kidney in the pathogenesis of chronic kidney disease especially in patients with diabetes mellitus or metabolic syndrome.

Aim: To review the most updated literature on fatty kidney and provide future research, diagnostic, and therapeutic perspectives on a disease increasingly affecting the contemporary world MATERIALS AND METHOD: We performed an extensive literature search through three databases including Embase (Elsevier) and the Cochrane Central Register of Controlled Trials (Wiley) and Pubmed/Medline Web of Science in November 2021 by using the following terms and their combinations: "fatty kidney", "ectopic fat", "chronic kidney disease", "cardiovascular event", "cardio-metabolic risk", "albuminuria" and "metabolic syndrome". Read More

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January 2022

Patient-Reported Outcome Measures Used for Assessing Breast Sensation after Mastectomy: Not Fit for Purpose.

Patient 2022 Jan 18. Epub 2022 Jan 18.

Department of Plastic, Reconstructive and Hand Surgery, GROW, School for Oncology and Developmental Biology, Maastricht University Medical Center, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands.

Aims: The aims of this review were (i) to evaluate whether patient-reported outcome measures used in clinical studies for assessing sensation after mastectomy and breast reconstruction are suitable for this purpose, and (ii) to explore whether any measures used for assessing sensation after non-oncologic breast surgery are worth modifying for use in post-mastectomy patients.

Methods: PRISMA guidelines were followed (PROSPERO number CRD42020178066). We searched six databases for studies of oncologic (i. Read More

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January 2022