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Breast Implant Illness May Be Rooted in Mast Cell Activation: A Case-Controlled Retrospective Analysis.

ObjectiveTo investigate the possible association between breast implant illness (BII) and mast cell activation syndrome (MCAS), which often manifests increased mast cells (MCs) in assorted tissues and may explain BII symptoms.BackgroundMechanisms by which implants cause BII symptoms remain unclear, but BII and MCAS symptom profiles heavily overlap, warranting investigation of potential linkage.MethodsWe retrospectively analyzed 20 implant patients who underwent explantation and total capsulectomy; 15 self-reported preoperatively they had BII (subject group); 5 felt they did not [control group

Glasgow Early Treatment Arm Favirpiravir (GETAFIX) for adults with early stage COVID-19: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The GETAFIX trial will test the hypothesis that favipiravir is a more effective treatment for COVID-19 infection in patients who … l Investigator or sub-Investigator 6. Known hypersensitivity to favipiravir, its metabolites or any excipients 7. Severe co-morbidities including: patients with severe hepatic impairment, defined as:  • greater than Child-Pugh grade A  • AST or ALT > 5 x ULN  • AST or ALT >3 x ULN and Total Bilirubin > 2xULN 8. More than 96 hours since first positive COVID-1 …

Подготовка и характеристика повода для высвобождения PVA: Na-Alg Микросфера, содержащая фамфридин.

ЦЕЛИ: В настоящем исследовании основное внимание уделяется как формулированию микросфер на основе биоизоляции, содержащих фэмфридин, для лечения множественного склероза, так и альтернативе коммерчески доступному продукту (Fampyra 10 мг, Biogen). МАТЕРИАЛЫ И МЕТОДЫ: Инкапсулирование фамфридина было достигнуто с использованием поливинил-алкоголиков (PVA) и алгинатов натрия (Na-Alg). Глутаральдегид (ГА) и соляная кислота (ГКИ) использовались в качестве связующих веществ. Проведена оценка полимерного соотношения (PVA: Na-Alg), лекарственного средства: полимерного соотношения (d:p), перекрестного с

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… Selectivity UV spectra at 262 nm were obtained for all excipients present in the microsphere content (HCl, GA, PVA, Na-Alg). The possibility of interference with fampridine at the same wavelength was evaluated. …

Effectiveness of a vitamin D regimen in deficient multiple myeloma patients and its effect on peripheral neuropathy.

PurposePeripheral neuropathy (PN) is common in multiple myeloma (MM) patients. More insight has been gained concerning the role of vitamin D in preventing PN. However, studies evaluating the effects of vitamin D3 supplementation on PN are lacking. The aims of this study are to (1) evaluate the effectiveness of a vitamin D3 regimen on achieving adequate vitamin D levels in deficient MM patients and to (2) exploratively evaluate the effect of vitamin D3 supplementation on PN.MethodsThirty-nine MM patients with inadequate (3 for 6 months according to a dose escalation regimen that consisted of on

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… These contraindications were the following: hypersensitivity to the active substance(s) or to any of the excipients; hypercalcemia (> 2.60 mmol/L) and/or hypercalciuria (> 8 mmol/24 h for 80 percentile method); nephrolithiasis and/or nephrocalcinosis (only for Cholecalciferol Mylan® [Canonsburg, PA, …

The Role of Purported Mucoprotectants in Dealing with Irritable Bowel Syndrome, Functional Diarrhea, and Other Chronic Diarrheal Disorders in Adults.

Chronic diarrhea is a frequent presenting symptom, both in primary care medicine and in specialized gastroenterology units. It is estimated that more than 5% of the global population suffers from chronic diarrhea. and that about 40% of these subjects are older than 60 years. The clinician is frequently faced with the need to decide which is the best therapeutic approach for these patients. While the origin of chronic diarrhea is diverse, impairment of intestinal barrier function, dysbiosis. and mucosal micro-inflammation are being increasingly recognized as underlying phenomena characterizing

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… treatments effectively diminished bowel movement frequency, but group differences were not found, while only diosmectite improved abdominal bloating at each visit Xyloglucan Alexea O, 2016 [ 131 ] Spain, Romania A mixture of vegetable oligo- and polysaccharides: 750 mg; reticulated protein: 250 mg; and the excipients … effectively diminished bowel movement frequency, but group differences were not found, while only diosmectite improved abdominal bloating at each visit Xyloglucan Alexea O, 2016 [ 131 ] | Spain, Romania | A mixture of vegetable oligo- and polysaccharides: 750 mg; reticulated protein: 250 mg; and the excipients …

Liposomal Nanoparticle Delivery of Ginkgo Flavone Glycosides Enhances SIRT1 Activation and Improves Diabetic Cardiomyopathy.

PurposeThis study aims to explore the therapeutic mechanisms of Ginkgo Flavone Glycosides (GFGs) delivered via liposomal nanoparticles in treating Diabetic Cardiomyopathy (DCM) by upregulating Sirtuin 1 (SIRT1) to restore energy metabolism and autophagy homeostasis.MethodsA DCM mouse model was employed, with groups treated with different doses of GFGs. Various evaluations, including body weight, blood glucose levels, and cardiac function, were performed. Network pharmacology, transcriptomic analysis, and molecular docking studies were conducted to elucidate the key role of SIRT1 in inhibiting

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… Currently, there are many advanced techniques available, such as electrospray technology, which can offer advantages in liposome preparation and thereby enhance drug delivery efficiency. 61 Existing studies have shown that polymeric excipients also hold potential advantages in many drug delivery systems … This can improve drug EE% and extend drug release from the formulation. 62 Therefore, subsequent studies will continue optimization by attempting to use natural polymer excipients, such as sodium alginate, as alternatives to lipids. In addition, this study primarily relied on animal models. …

Over-the-counter and compounded mouthwashes for radiotherapy-induced xerostomia: a randomized controlled trial.

Head and neck radiotherapy quantitatively and qualitatively compromises salivary flow, and salivary substitutes have the potential to alleviate the symptoms. This study aims to assess the effectiveness of two salivary substitutes in relieving symptoms of radiotherapy-induced xerostomia through a double-blind randomized controlled trial. Twenty-four patients were selected from a dental oncology clinic and randomly assigned to the over-the-counter or compounded mouthwash group. Each patient was instructed to rinse their oral cavity with the assigned solution three times a day for 30 days. Both p

A Systematic Review of Sildenafil Mortality Through the Years.

Sildenafil is a medication used for the treatment of erectile dysfunction. It was approved by the U.S. Food and Drug Administration (FDA) in 1998. Several articles have raised concerns regarding the use of sildenafil and the occurrence of serious adverse events, such as myocardial ischemia, stroke, and even death. Our aim is to systematically review the existing literature on mortality associated with sildenafil use. The method used for this systematic review was completed by searching three databases: PubMed, Scopus, and Web of Science. Articles were screened and assessed for eligibility. Thi

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… Analytical Profiles of Drug Substances and Excipients. Vol. 27. Amsterdam: Elsevier; 2001. Sildenafil citrate; pp. 339–376. 4. Use of sildenafil (Viagra) in patients with cardiovascular disease. Technology and Practice Executive Committee. …

Efficacy and safety of stem cell therapy in type 1 diabetes: A systematic review and meta-analysis of randomised controlled trials.

Background and objectives Stem cell therapy has emerged as a potential treatment for type 1 diabetes mellitus (T1DM), offering the possibility of modifying disease progression. This systematic review and meta-analysis aimed to assess the efficacy and safety of stem cell therapy in patients with T1DM. Methods We searched PubMed, Embase, Web of Science, and CENTRAL for randomised controlled trials (RCTs) published until January 2025 that evaluated stem cell therapy in T1DM. The primary outcome was the glycated haemoglobin (HbA1c) level. The secondary outcomes included fasting C-peptide levels, i

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… of Stem Cell Sciences and Technologies, NCT04078308 Carlsson et al 14 (2023); Sweden | Double-blind, placebo-controlled RCT | 18-40 yr T1DM Onset < 2 yr fasting plasma C-peptide concentration >0.36 ng/mL | Wharton jelly MSC 200 million cells via IV route N=10(4 females) Mean age: 31±9 yr, | Placebo (Excipients …

Qualitative study of kinesiophobia in patients with tumors after PICC catheterization.

To explore the kinesiophobia experience of patients with tumors after PICC catheterization and to analyze patients' views and true inner feelings about kinesiophobia, with the goal of providing a reference for reducing the occurrence of kinesiophobia and enhancing the experience of patients undergoing this procedure. A purposive sampling method was used to select patients with tumors that required the placement of a PICC line in a tertiary hospital in Ningbo City, Zhejiang Province, as the research object. A semistructured in-depth interview method was used for data collection, and the content

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… For this population, prolonging the time of puncture point compression (e.g., ≥ 15 min) and supplementing it with elastic bandage pressure bandages in clinical care are recommended, and the use of alginate excipients can effectively prevent and reduce blood seepage after PICC placement in patients with …

MUKtwelve protocol: a phase II randomised, controlled, open, parallel group, multicentre trial of selinexor, cyclophosphamide and prednisolone (SCP) versus cyclophosphamide and prednisolone (CP) in patients with relapsed or refractory multiple myeloma.

IntroductionMultiple myeloma is a malignancy of plasma cells with around 6000 new cases per year in the UK. Cyclophosphamide plus prednisolone is considered a standard of care for disease and symptom control in the advanced relapsed or refractory myeloma setting within the UK NHS. The selective nuclear export inhibitor, selinexor, has been relatively well tolerated in previous clinical trials and offers promise when used in combination with a wide range of other anti-cancer treatments. Here, we investigate if the addition of selinexor can improve responses to cyclophosphamide plus prednisolone

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… conditions that might, in the opinion of the Investigator, interfere with the absorption or swallowing of the trial drug(s) Female participants who are lactating or have a positive pregnancy test at screening Known allergy or previous intolerance to any of the trial medications, their analogues, or excipients …

Spotlight on ixazomib: potential in the treatment of multiple myeloma.

Despite the significant therapeutic advances achieved with proteasome inhibitors (PIs) such as bortezomib and carfilzomib in prolonging the survival of patients with multiple myeloma, the development of drug resistance, peripheral neuropathy, and pharmacokinetic limitations continue to pose major challenges when using these compounds. Ixazomib is a second-generation PI with improved activity over other PIs. Unlike bortezomib and carfilzomib, which are administered by injection, ixazomib is the first oral PI approved by US Food and Drug Administration. This review discusses the biochemical prop

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… cardiovascular conditions (hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months), HIV, positive hepatitis B surface antigen, hepatitis C infection, or patient allergy to any of the medications, analogs of the medications, or excipients …

Analgesic efficacy of zoledronic acid and its effect on functional status of prostate cancer patients with metastasis.

ObjectivesA multi-centered observational study evaluated the efficacy of zoledronic acid for improving pain and mobility, and preventing skeletal-related events (SRE) (fracture, spinal compression, pain-relieving radiotherapy), in patients with prostate cancer and bone metastasis.Materials and methodsMales (n = 218) with prostate cancer and bone metastasis undergoing oncologic therapy received zoledronic acid (4 mg iv/month) for 6 months. Parameters evaluated were: 1) pain and movement after 2 consecutive doses; 2) quality of life; 3) SRE incidence and time-to-appearance. Medication tolerance

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… Exclusion criteria Patients with hypersensitivity to zoledronic acid, to bisphosphonates, or to any excipients of the zoledronic acid formulation; patients with noncompliance to medications and those considered potentially unreliable; patients with altered renal function with levels of creatinine >265 …

The MUK eight protocol: a randomised phase II trial of cyclophosphamide and dexamethasone in combination with ixazomib, in relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenalidomide and a proteasome inhibitor.

BackgroundMultiple myeloma is a plasma cell tumour with approximately 5500 new cases in the UK each year. Ixazomib is a next generation inhibitor of the 20S proteasome and is thought to be an effective treatment for those who have relapsed from bortezomib. The combination of cyclophosphamide and dexamethasone (CD) is a recognised treatment option for patients with relapsed refractory multiple myeloma (RRMM) who have relapsed after treatment with bortezomib and lenalidomide, whilst also often being combined with newer proteasome inhibitors. The most apparent combination for ixazomib is therefor

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… absorption of the study drug ●Active symptomatic fungal, bacterial, and/or viral infection including known active HIV or known viral (A, B or C) hepatitis ●Female participants who are lactating or have a positive pregnancy test at screening ●Known allergy to any of the study medications, their analogues, or excipients …

SIADH-related hyponatremia in hospital day care units: clinical experience and management with tolvaptan.

Hyponatremia (Na ˂ 135 mmol/l) is the most frequent electrolyte disorder in clinical practice, and the syndrome of inappropriate antidiuretic hormone secretion (SIADH) is the commonest cause of hyponatremia in cancer patients. Correcting hyponatremia in these patients can reduce morbidity and mortality, increase the response to anti-cancer agents, and help reduce hospital length of stay and costs. Tolvaptan is an oral medication used to treat SIADH-related hyponatremia patients that needs to be initiated at hospital so patients can have their serum sodium monitored. If tolvaptan could be initi

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… Patients must not present any contraindications for the use of tolvaptan like hypersensitivity to the active substance/excipients, anuria, volume depletion, hypovolemic hyponatremia, and hypernatremia, patients who cannot perceive thirst and pregnancy or breast feeding [ 9 ]. …

Effect of dexamethasone in patients with ARDS and COVID-19 - prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg d … l if they meet any of the following criteria: 1. Known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); 2. Fulfilled criteria for ARDS for ≥14 days at enrolment; 3. Pregnancy or breastfeeding; 4. Unwillingness to comply with contraception measurements from enrolment until at lea …

Early antiviral treatment in outpatients with COVID-19 (FLARE): a structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The objective of this trial is to assess whether early antiviral therapy in outpatients with COVID-19 with either favipiravir pl … es Exclusion criteria are as follows: 1. Known hypersensitivity to any of the active ingredients or excipients in favipiravir and matched placebo, and in lopinavir/ritonavir and matched placebo (See Appendix 2) 2. Chronic liver disease at screening (known cirrhosis of any aetiology, chronic hepatitis (e.g. autoimmune, viral, steatohepatitis), cholangitis or …

Phase 1/2 trial of ixazomib, cyclophosphamide and dexamethasone in patients with previously untreated symptomatic multiple myeloma.

Ixazomib is the first oral proteasome inhibitor to enter the clinic. Given the efficacy of bortezomib in combination with cyclophosphamide and dexamethasone, we studied the combination of ixazomib, cyclophosphamide and dexamethasone (ICd) in newly diagnosed multiple myeloma (NDMM) and patients with measurable disease, irrespective of transplant eligibility, were enrolled. The phase 1 was to determine the maximum tolerated dose (MTD) of cyclophosphamide in the combination. Patients received ixazomib 4 mg (days 1, 8, 15), dexamethasone 40 mg (days 1, 8, 15, 22), and cyclophosphamide 300 or 400 m

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… heart failure, unstable angina, or myocardial infarction within the past 6 months), known human immunodeficiency virus infection, known hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection, and known allergy to any of the study medications, their analogs, or excipients …

Resveratrol Nanoformulations for Cancer Management: A Comprehensive Review of Disease-Specific Strategies and Clinical Translational Barriers.

Cancer remains a leading cause of mortality worldwide, highlighting the need for therapeutic strategies that reduce systemic toxicity and drug resistance. Resveratrol (RES), a natural polyphenolic stilbenoid, possesses antioxidant, anti-inflammatory, pro-apoptotic, anti-metastatic, and chemosensitizing activities. However, its clinical translation is limited by poor aqueous solubility, chemical instability, rapid metabolic clearance, and consequently low systemic bioavailability. Nanotechnology-based drug delivery systems provide a promising strategy to address these limitations. This review s

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… use | IV combination therapy; resistant breast/lung cancer; stromal or immune-pathway modulation | 70–150 nm SLNs/NLCs/liquid-crystalline lipid NPs | High physical stability; high EE; oral, pulmonary, topical, and microneedle-compatible delivery | Lipid polymorphism; matrix expulsion; active lipid excipients …

Glucocorticoids-based prodrug design: Current strategies and research progress.

Attributing to their broad pharmacological effects encompassing anti-inflammation, antitoxin, and immunosuppression, glucocorticoids (GCs) are extensively utilized in the clinic for the treatment of diverse diseases such as lupus erythematosus, nephritis, arthritis, ulcerative colitis, asthma, keratitis, macular edema, and leukemia. However, long-term use often causes undesirable side effects, including metabolic disorders-induced Cushing's syndrome (buffalo back, full moon face, hyperglycemia, etc.), osteoporosis, aggravated infection, psychosis, glaucoma, and cataract. These notorious side e