91,195 results match your criteria evaluate safety


Microneedling-assisted topical tranexamic acid solution versus 4% hydroquinone for treating melasma: A split-face randomized study.

J Cosmet Dermatol 2021 Sep 15. Epub 2021 Sep 15.

Department of Dermatology, National Research Centre, Egypt.

Background: Melasma, also known as chloasma or mask of pregnancy, is a common, acquired, hyperpigmentary disorder usually affecting females. Tranexamic acid (TA), a derivative of amino acid lysine, has shown promising results over the past few years when used along with other therapies and when used as a stand-alone therapy.

Aim Of The Work: In this study, we aimed to evaluate and compare the effectiveness of topically applied tranexamic acid after microneedling versus topically applied hydroquinone (HQ) 4% alone in patients with melasma. Read More

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September 2021

Adoptive T-cell immunotherapy in digestive tract malignancies: Current challenges and future perspectives.

Cancer Treat Rev 2021 Sep 4;100:102288. Epub 2021 Sep 4.

Department of Biomedical Sciences and Human Oncology, University of Bari "Aldo Moro", 70124 Bari, Italy.

Multiple systemic treatments are currently available for advanced cancers of the digestive tract, but none of them is curative. Adoptive T-cell immunotherapy refers to the extraction, modification and re-infusion of autologous or allogenic T lymphocytes for therapeutic purposes. A number of clinical trials have investigated either non-engineered T cells (i. Read More

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September 2021

Safety and Immunogenicity of an Anti-Zika Virus DNA Vaccine.

N Engl J Med 2021 Sep;385(12):e35

From the Division of Infectious Diseases, Perelman School of Medicine, University of Pennsylvania (P.T.), and Wistar Institute (K.M., E.L.R., S.B.K., F.I.Z., H.C., D.B.W.), Philadelphia, and Inovio Pharmaceuticals, Plymouth Meeting (S.W., A.S.K., J.B., M.B.) - all in Pennsylvania; GeneOne Life Science, Seoul, South Korea (C.C.R., Y.K.P., C.R., S.E.S., J.N.M.); Infectious Diseases Research Centre-Université Laval, Quebec, QC, Canada (T.R., S.T., G.P.K.); QPS-Miami Research Associates, Miami, (D.K.); and the Department of Medicine, Morristown Medical Center, Morristown, NJ (J.N.M.).

Background: Although Zika virus (ZIKV) infection is typically self-limiting, other associated complications such as congenital birth defects and the Guillain-Barré syndrome are well described. There are no approved vaccines against ZIKV infection.

Methods: In this phase 1, open-label clinical trial, we evaluated the safety and immunogenicity of a synthetic, consensus DNA vaccine (GLS-5700) encoding the ZIKV premembrane and envelope proteins in two groups of 20 participants each. Read More

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September 2021

Protective effects of selenium nanoparticle-enriched NZ9000 against enterotoxigenic K88-induced intestinal barrier damage in mice.

Appl Environ Microbiol 2021 Sep 15:AEM0163621. Epub 2021 Sep 15.

The Key Laboratory for Space Bioscience and Biotechnology, School of Life Sciences, Northwestern Polytechnical University, Xi'an, Shaanxi 710072, China.

Composite microecological agents have received widespread attention due to their advantageous properties, including safety, multi-effects, and low cost. This study was conducted to evaluate the protective effects of selenium (Se) nanoparticle-enriched NZ9000 ( NZ9000-SeNPs) against enterotoxigenic K88 (ETEC K88)-induced intestinal barrier damage in C57BL/6 mice. Oral administration of NZ9000-SeNPs significantly increased the villi height and the number of goblet cells in the ileum, and reduced the levels of serum and ileal interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), and interferon-γ (IFN-γ), and increased the activities of thioredoxin reductase (TrxR) and glutathione peroxidase (GSH-Px) compared with the ETEC K88-infected group not treated with NZ9000-SeNPs. Read More

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September 2021

Evaluation of Epidural Analgesia Use During Labor and Infection in Full-term Neonates Delivered Vaginally.

JAMA Netw Open 2021 Sep 1;4(9):e2123757. Epub 2021 Sep 1.

Department of Anesthesia, the International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Importance: Quantification of potential consequences associated with the use of epidural analgesia during labor could help to improve the safety and quality of labor and delivery care for parturient women.

Objective: To evaluate the association between epidural analgesia use during labor and neonatal infection in a large cohort of parturient women.

Design, Setting, And Participants: This propensity score-matched cohort study was conducted at a university-affiliated hospital in Shanghai, China. Read More

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September 2021

Apatinib Combined with Paclitaxel and Cisplatin Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma.

Cancer Biother Radiopharm 2021 Sep 15. Epub 2021 Sep 15.

Department of Internal Medicine, First Hospital of Xingtai City, Xingtai, China.

We conducted a trial to evaluate the efficacy and safety of apatinib, a tyrosine inhibitor against vascular endothelial growth factor receptor 2, combined with neoadjuvant chemotherapy in patients with locally advanced esophageal squamous cell carcinoma (ESCC). One hundred twenty six patients were randomized into two cycles of paclitaxel and cisplatin (TP) ( = 61) or combined with apatinib (Apa+TP) ( = 65), followed by surgery. The primary endpoint was objective response rate (ORR). Read More

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September 2021

A phase I study to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic profiles of ocular GLH8NDE in healthy male adults.

Clin Transl Sci 2021 Sep 15. Epub 2021 Sep 15.

Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul, Korea.

GLH8NDE, a derivative of eupatilin, is currently under development to treat dry eye disease. We conducted a randomized, double-masked, placebo-controlled, single- and multiple-day study to evaluate safety, tolerability, pharmacodynamics, and pharmacokinetics of ocular GLH8NDE in healthy male adults. Subjects randomly received topical ocular dosing of GLH8NDE or its matching placebo for a day, then for 7 consecutive days with a 62-h washout at one of the following daily doses: 9, 18, 36 (Koreans), and 36 mg (Whites). Read More

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September 2021

Mid- and Long-Term Follow-Up Efficacy Analysis of 3D-Printed Interbody Fusion Cages for Anterior Cervical Discectomy and Fusion.

Orthop Surg 2021 Sep 15. Epub 2021 Sep 15.

Department of Orthopaedics, The Second Hospital of Shanxi Medical University, Taiyuan, China.

Objective: To evaluate the safety and stability of 3D-printed interbody fusion cages (3D-printed cages) in anterior cervical discectomy and fusion (ACDF) by investigating the mid- and long-term follow-up outcomes.

Methods: In this prospective study, the clinical data of 30 patients with CSM admitted to the Second Hospital of Shanxi Medical University from May 2012 to May 2014 were analyzed. The cohort comprised 18 males and 12 females with an average age of 60. Read More

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September 2021

Safety and clinical efficacy of the double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicenter cohort study.

Clin Transl Sci 2021 Sep 15. Epub 2021 Sep 15.

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and Endoscopy Unit, Milan, Italy.

Data regarding double switching from originator infliximab (IFX) to IFX biosimilars in inflammatory bowel diseases (IBDs) are lacking. The purpose of this study was to evaluate the safety and efficacy of switching from originator IFX to CT-P13 and subsequently to SB2 (double switch) in patients with IBD. Patients undergoing IFX-double switch in eight Centers in Lombardy (Italy) from November 2018 to May 2019 were retrospectively analyzed. Read More

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September 2021

Understanding delays in the introduction of complementary foods in rural Ethiopia.

Matern Child Nutr 2021 Sep 15:e13247. Epub 2021 Sep 15.

Center for Food Science and Nutrition. College of Natural Sciences, Addis Ababa University, Addis Ababa, Ethiopia.

Age-appropriate breastfeeding and introduction to complementary foods can shape child feeding practices, ensure adequate energy and nutrient intake and prevent linear growth faltering. This study aimed to assess mothers' and health workers' knowledge of timely introduction to complementary foods and evaluate the relationship between delays in complementary feeding and subsequent linear growth. We conducted two rounds of surveys (March/August 2017) among 249 health workers (n = 249) and caregivers (n = 2635) of children 6-23 months of age. Read More

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September 2021

Patterns and outcomes of high-voltage versus low-voltage pediatric electrical injuries: an 8-year retrospective analysis of a tertiary-level burn center.

J Burn Care Res 2021 Sep 15. Epub 2021 Sep 15.

University of Health Sciences, Adana City Training and Research Hospital, Department of General Surgery, Burn Center, Adana, Turkey.

Introduction: Although electrical injuries (EIs) are rare traumas in the pediatric age group, they are considered one of the most devastating injuries. We aimed to evaluate the patterns and outcomes of pediatric high-voltage (HVI) vs. low-voltage injuries (LVIs), admitted to the burn center within the efforts of determining evidence-based data for contributing to burn prevention strategies. Read More

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September 2021

[Effectiveness and safety of tranexamic acid combined with intraoperative controlled hypotension on reducing perioperative blood loss in primary total hip arthroplasty].

Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi 2021 Sep;35(9):1133-1140

Department of Orthopedics, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P.R.China.

Objective: To evaluate the effectiveness and safety of tranexamic acid (TXA) combined with intraoperative controlled hypotension (ICH) for reducing perioperative blood loss in primary total hip arthroplasty (THA).

Methods: The clinical data of 832 patients with initial THA due to osteonecrosis of femoral head between January 2017 and July 2020 were retrospectively analyzed. All patients received TXA treatment, and 439 patients (hypotension group) received ICH treatment with an intraoperative mean arterial pressure (MAP) below 80 mm Hg (1 mm Hg=0. Read More

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September 2021

Evaluation of natural radioactivity levels and potential radiological hazards of common building materials utilized in Mediterranean region, Turkey.

Environ Sci Pollut Res Int 2021 Sep 15. Epub 2021 Sep 15.

Department of Electronics and Communication, Faculty of Engineering and Architecture, Beykent University, Sarıyer, İstanbul, Turkey.

Radiometric measurement of building materials is very important to assess the internal and external exposure caused by the ionizing radiation emitted from terrestrial radionuclides in building materials. The activity concentrations of Ra, Th, and K in fifty-eight samples of fifteen different structural and covering building materials commonly used in Osmaniye province located in the Mediterranean region of Turkey were measured by using gamma-ray spectroscopy. The activity concentrations of Ra, Th, and K varied from 2. Read More

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September 2021

Safety of Thermosensor Insertion in the Midline of the Spinal Canal Anterior to the Dura: A Cadaveric Study.

Cardiovasc Intervent Radiol 2021 Sep 14. Epub 2021 Sep 14.

Department of Interventional Radiology, Nouvel Hôpital Civil, 1, place de l'Hôpital, 67096, Strasbourg Cedex, France.

Objective: To evaluate the safety of the insertion of a blunt-tip thermosensor inside the anterior epidural space using the trans-osseous route in the dorsal spine and the double oblique trans-foraminal approach in the lumbar spine.

Materials And Methods: A total of 10 attempts were made on a 91 years old human specimen. Thermosensors were inserted under fluoroscopic guidance in the anterior part of the spinal canal using various oblique angulations. Read More

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September 2021

analysis of novel dipeptidyl peptidase-IV inhibitory peptides released from antimicrobial protein 2 (MiAMP2) and the possible pathways involved in diabetes protection.

Curr Res Food Sci 2021 2;4:603-611. Epub 2021 Sep 2.

Faculty of Agriculture and Food, Yunnan Institute of Food Safety, Kunming University of Science and Technology, Kunming, 650500, Yunnan, China.

The aim of the present study was to screen novel dipeptidyl peptidase IV (DPP-IV) inhibitory peptides from antimicrobial protein 2 (MiAMP2) and evaluate the potential antidiabetic targets and involved signaling pathways using approaches. digestion of MiAMP2 with pepsin, trypsin and chymotrypsin was performed with ExPASy PeptideCutter and the generated peptides were subjected to BIOPEP-UWM, iDrug, INNOVAGEN and Autodock Vina for further analyses. Six novel peptides EQVR, EQVK, AESE, EEDNK, EECK, and EVEE were predicted to possess good DPP-IV inhibitory potentials, water solubility, and absorption, distribution, metabolism, excretion, and toxicity properties. Read More

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September 2021

Compound glycyrrhizin injection for improving liver function in children with acute icteric hepatitis: A systematic review and meta-analysis.

Integr Med Res 2022 Mar 21;11(1):100772. Epub 2021 Aug 21.

Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.

Background: Compound glycyrrhizin injection (CGI) is a preparation with glycyrrhizin as the main active ingredient extracted from licorice. As clinical trials suggest that CGI is effective in improving liver function for acute icteric hepatitis in children (AIHC), this systematic review aimed to evaluate and verify its therapeutic effects and safety.

Methods: Six electronic databases were searched from their inception to 15 May 2021. Read More

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The prevalence of burnout syndrome and its association with adherence to safety and practice standards among anesthetists working in Ethiopia.

Ann Med Surg (Lond) 2021 Sep 3;69:102777. Epub 2021 Sep 3.

School of Medicine Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, UK.

Background: Burnout amongst healthcare professionals is a serious challenge affecting health care practice and quality of care. The ongoing pandemic has highlighted this on a global level. This study aimed to determine the prevalence of burnout syndrome and its association with adherence to safety and practice standards among non-physician anesthetists in Ethiopia. Read More

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September 2021

Biological Therapy in Noninfectious Pediatric Uveitis: A Systematic Review.

Clin Ophthalmol 2021 7;15:3765-3776. Epub 2021 Sep 7.

Department of Surgical Specialties and Anesthesiology (Ophthalmology Division), Botucatu Medical School, São Paulo State University (UNESP), Botucatu, São Paulo, Brazil.

Purpose: Noninfectious pediatric uveitis is a potentially blinding disease often associated with systemic conditions. In cases of chronic anterior uveitis without adequate response to steroids and immunosuppressants, biological response modifiers would be viable therapeutic options. Still, evidence is lacking on the safety of the long-term use of these drugs in children. Read More

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September 2021

Developing, piloting and evaluating a Medicines Safety School Programme to be delivered by student pharmacists.

Curr Pharm Teach Learn 2021 Oct 24;13(10):1319-1323. Epub 2021 Jul 24.

School of Pharmacy & Life Sciences, Robert Gordon University, Aberdeen AB10 7QB, Scotland, United Kingdom. Electronic address:

Introduction: This project aimed to develop content, pilot delivery, and evaluate effectiveness of an innovative Medicines Safety School Programme delivered by student pharmacists to primary school pupils.

Methods: A collaborative approach between academic staff and a primary school guided programme content. The interactive workshop focused on benefits of medicines when used correctly and harmful effects associated with misuse. Read More

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October 2021

Factors delaying chemotherapy in patients with breast cancer at a safety-net hospital.

J Natl Med Assoc 2021 Sep 11. Epub 2021 Sep 11.

Department of Medicine, Alameda Health System- Highland Hospital: 1411 E 31(st), 2(nd) Floor A2, Oakland CA, 94602 USA. Electronic address:

Background: Despite advances in healthcare and improved chemotherapy, disparities in breast cancer outcomes continue to persist. Our aim was to evaluate socioeconomic factors that may impact timing of treatment for patients receiving chemotherapy in underserved communities.

Methods: A review of patients with breast cancer who received neoadjuvant or adjuvant chemotherapy from 2015-2019 was conducted at a safety-net hospital. Read More

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September 2021

Effect of Lycium barbarum polysaccharide supplementation in non-alcoholic fatty liver disease patients: study protocol for a randomized controlled trial.

Trials 2021 Aug 26;22(1):566. Epub 2021 Aug 26.

School of Public Health and Management, Ningxia Medical University, 1160 Shengli Street, Yinchuan, 750004, China.

Background: Non-alcohol fatty liver disease (NAFLD) is the most common chronic liver disease in the world, with a high incidence and no effective treatment. At present, the targeted therapy of intestinal microbes for NAFLD is highly valued. Lycium barbarum polysaccharide (LBP), as the main active ingredient of Lycium barbarum, is considered to be a new type of prebiotic substance, which can improve NAFLD by regulating the gut microbiota. Read More

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Intracerebroventricular injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer's disease dementia: a phase I clinical trial.

Alzheimers Res Ther 2021 Sep 14;13(1):154. Epub 2021 Sep 14.

Departments of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 80 Ilwon-ro, Gangnam-gu, Seoul, 135-710, Republic of Korea.

Backgrounds: Alzheimer's disease is the most common cause of dementia, and currently, there is no disease-modifying treatment. Favorable functional outcomes and reduction of amyloid levels were observed following transplantation of mesenchymal stem cells (MSCs) in animal studies.

Objectives: We conducted a phase I clinical trial in nine patients with mild-to-moderate Alzheimer's disease dementia to evaluate the safety and dose-limiting toxicity of three repeated intracerebroventricular injections of human umbilical cord blood-derived MSCs (hUCB-MSCs). Read More

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September 2021

Colchicine - an effective treatment for children with a clinical diagnosis of autoinflammatory diseases without pathogenic gene variants.

Pediatr Rheumatol Online J 2021 Sep 14;19(1):142. Epub 2021 Sep 14.

Pediatric Rheumatology and Autoinflammatory Reference Center, University Children's Hospital Tuebingen, University of Tuebingen, Tuebingen, Germany.

Background: Autoinflammatory diseases (AID) are rare chronic conditions with high disease burden, affecting children and adults. Clinically and genetically confirmed, AID can be effectively treated with targeted cytokine inhibition. In contrast, for patients with clinical AID symptoms without pathogenic gene variants, no treatment recommendations are available. Read More

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September 2021

Online training in evidence-based medicine and research methods for GP registrars: a mixed-methods evaluation of engagement and impact.

BMC Med Educ 2021 Sep 14;21(1):492. Epub 2021 Sep 14.

Faculty of Health Sciences and Medicine, Bond University, Gold Coast, 4229, Australia.

Background: Evidence-based medicine (EBM) is a core skillset for enhancing the quality and safety of patients' care. Online EBM education could improve clinicians' skills in EBM, particularly when it is conducted during vocational training. There are limited studies on the impact of online EBM training on clinical practice among general practitioner (GP) registrars (trainees in specialist general practice). Read More

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September 2021

Brachytherapy with Iodine-125 seeds for treatment of portal vein-branch tumor thrombus in patients with hepatocellular carcinoma.

BMC Cancer 2021 Sep 14;21(1):1020. Epub 2021 Sep 14.

Department of Interventional Radiology, The First Hospital of China Medical University, No.155 Nanjing Road, Heping District, Shenyang, 110000, Liaoning, China.

Background: There is currently no widely-accepted consensus for the management of hepatocellular carcinoma with portal vein tumor thrombus. We evaluate the safety and efficacy of ultrasound-guided percutaneous brachytherapy with iodine-125 seeds for the treatment of hepatocellular carcinoma with portal vein-branch tumor thrombus (PVBTT).

Methods: Sixty-nine hepatocellular carcinoma patients with PVBTT were enrolled; 34 received transarterial chemoembolization (TACE) combined with iodine-125 seeds implanted in the PVBTT; 35 were treated with TACE alone. Read More

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September 2021

Hugan tablets for the treatment of RUCAM based drug-induced liver injury: a propensity score matching analysis using a nationwide database.

Expert Rev Clin Pharmacol 2021 Sep 15. Epub 2021 Sep 15.

Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200001, China.

Background: Drug-induced liver injury (DILI) is a major clinical challenge with no specific therapeutic drugs available. It is crucial to develop new agents to improve the clinical outcome of patients with DILI. In this study, we aimed to evaluate the efficacy and safety of Hugan tablets in patients with RUCAM based DILI using a nationwide database. Read More

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September 2021

[High frequency ultrasound combined with ultrasound-guided core needle biopsy for the diagnosis of primary thyroid lymphoma].

Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi 2021 Aug;56(8):858-862

Department of Pathology, Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou 310016, China.

To investigate the sonographic features of primary thyroid lymphoma (PTL) and to evaluate the clinical significance of ultrasound-guided core needle biopsy (US-CNB) in PTL. A total of 24 patients with suspected PTL in Sir Run Run Shaw Hospital from January 2013 to June 2018 were analyzed retrospectively. All cases were confirmed by pathology, of them 23 patients received US-CNB and 1 patient chose operation without US-CNB, including 5 males and 19 females, aged from 39 to 75 years old. Read More

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Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Evaluate the Absorption of Midazolam Rectal Gel.

Eur J Pharm Sci 2021 Sep 11:106006. Epub 2021 Sep 11.

Phase I Clinical Trial Unit, the First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, China; Department of Clinical Pharmacology, School of Pharmacy College, Nanjing Medical University, Nanjing 211166, China. Electronic address:

Objective: We aimed to 1) develop physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) models of a novel midazolam rectal gel in healthy adults, 2) assess the contribution of different physiologically relevant factors in rectal absorption, and 3) to provide supports for future clinical studies of midazolam rectal gel.

Methods: We developed the rectal PBPK model after built the intravenous and the oral PBPK model. Then, the physiological progress of rectal route was described in terms of the drug release, the rectal absorption and the particle first-pass elimination. Read More

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September 2021

Evaluation of the efficacy and safety of plasma exeresis in periorbital rejuvenation using the Reviscometer.

J Cosmet Dermatol 2021 Sep 14. Epub 2021 Sep 14.

Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Background: Periorbital rejuvenation is performed through various methods. Recently, plasma exeresis has been suggested for the treatment of dermatochalasis and periorbital wrinkles.

Aims: To evaluate the clinical efficacy and safety of plasma exeresis in periorbital rejuvenation and palpebral laxity and assess its effectiveness using the Reviscometer . Read More

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September 2021

An endovaginal MRI array with a forward-looking coil for advanced gynecological cancer brachytherapy procedures: design and initial results.

Med Phys 2021 Sep 14. Epub 2021 Sep 14.

Medicine, Johns Hopkins University, Baltimore, MD, 21287, USA.

Purpose: Develop an endovaginal MRI array that provides signal enhancement forward into the posterior parametrium and sideways into the vaginal wall, accelerating multiple-contrast detection of residual tumors that survive external-beam radiation. The array's enclosure should form an obturator for cervical-cancer brachytherapy, allowing integration with MRI-guided catheter placement, CT and interstitial radiation-dose delivery.

Methods: The endovaginal array consisted of forward-looking and sideways-looking components. Read More

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September 2021