clinical safety Articles
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An evaluation of the AccuCinch Ventricular Restoration System in symptomatic heart failure patients with reduced ejection fraction (HFrEF) - Case Study
Study Overview: Design: Prospective, randomized, open-label, multi-center, international, clinical safety and efficacy investigation. Randomization: Treatment with AccuCinch System plus guideline-directed medical therapy (GDMT) or GDMT alone. Enrollment: 400 randomized subjects at up to 80 centers worldwide ...
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Safety and immunogenicity of bivalent inactivated vaccine against haemorrhagic fever with renal syndrome in a phase II trial on healthy Chinese volunteers
We have developed a cell culture-derived, inactivated bivalent vaccine against both Haemorrhagic Fever with Renal Syndrome (HFRS) viruses 84 Fli (type I) and L99 (type II). This purified vaccine was tested in the clinical phase I/II trial in healthy non-infected adults in China. About 518 volunteers in Southern region and 650 volunteers from the Northern region of China were vaccinated. ...
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A Survey of Environmental Safety Issues at 20 Medical Clinics
In the study described in this article, the authors performed safety walk-throughs or inspections for 20 clinics located both inside a major medical center clinic (onsite) and away from the main clinic site (offsite). A checklist was used to evaluate compliance with institutional, local, state, and federal guidelines and regulations. The results obtained at onsite clinics were compared with the ...
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Anti-HIV and anti-inflammatory action of iodine-lithium-α-dextrin is accompanied by the improved quality of life in AIDS patients
Clinical efficacy, tolerability and safety of various doses of Iodine-Lithium-α-Dextrin (ILαD) monotherapy have been evaluated in 56 HIV-infected patients enrolled in double blind uncontrolled randomised study during 48 weeks follow-up period. ILαD was administered intravenously three times over five days with intervals of 23 weeks between treatments for a total of 12 infusions in 4 cycles. HIV-1 ...
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Mechanism of action and therapeutic efficacy of the biotechnology-derived immunostimulating extract OM-85 in respiratory tract infections
The burden of Respiratory Tract Infections (RTIs) in children and adults is very high, especially in developing countries. At least 1.9 million children throughout the world died from acute RTIs in 2000, 70% of them in Africa and Southeast Asia. As causative therapies of these frequently recurring infections have substantial limits, preventive measures deserve priority. Among these, non-specific ...
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A Phase 1 Study Investigating the Combination of AFM13 and the Monoclonal Anti-PD-1 Antibody Pembrolizumab in Patients with Relapsed/Refractory Hodgkin Lymphoma after Brentuximab Vedotin Failure: Updated Safety and Efficacy Data
AFM13 is a first-in-class tetravalent, bispecific NK cell engager that binds to CD30 on tumor cells and CD16A on NK cells. By engaging CD16-positive NK cells, AFM13 leads to NK cell-mediated killing of tumor cells.1 Pembrolizumab (Keytruda®) is approved in patients with R/R classical Hodgkin lymphoma as monotherapy. AFM13 showed single agent clinical activity with solid safety profile in a ...
By Affimed GmbH
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Application of Flow Cytometry in the Pharmaceutical Industry
Flow cytometry (FC) is an important tool for analyzing complex pathways and responses of single cells, which can track cell phenotypes and functions in multiple dimensions. It is also increasingly applied in drug development. FC not only can detect intracellular and extracellular components, but also detect soluble analytes in serum or plasma samples, such as cytokines, drug complexes, or ...
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Making the Business Case for Office-Based Hysteroscopy Procedures
For OB/GYN practices looking at the possibility of providing office-based hysteroscopy procedures, the benefits such a move would offer patients is a primary consideration. However, practices must weigh those against multiple economic factors—including capital outlay and reimbursement. To help practices make a more informed decision, this paper provides an overview of the business case for ...
By LUMINELLE
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How eCOA Improves Patient Experience and Data Quality
With the rising demand for improving patient safety in clinical trials, the adoption of patient-centric solutions is considered the best route to enhance data accuracy and experience automated workflows. This is where eCOA comes into play. In this blog post, we will find out how electronic clinical outcome assessments are helping the clinical trials industry handle the ever-growing list of ...
By Clinion
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The Need for an Expanded Role of Risk Management in Healthcare
The role of risk management in healthcare has come a long way over the years. But as risks to the healthcare industry multiply—both in number and costs—risk management and risk managers need to be at the forefront of the business. If not, healthcare organizations can’t thrive, or potentially even survive. How healthcare risk management has evolved Today’s ...
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Enhancing Healthcare Security: The Role of Door Frame Metal Detectors in Hospitals and Clinics
Enhancing Healthcare Security: The Role of Door Frame Metal Detectors in Hospitals and Clinics The safety and security of patients, healthcare professionals, and visitors are paramount in hospitals and clinics. With the evolving landscape of security threats, the implementation of robust security measures is essential to ensure a secure environment conducive to healing and care. Door frame metal ...
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Avoiding Regulatory shortfalls in the Submission Path
Commercialization of new drugsrequire careful navigation through complex regulations defined by Global health authorities. Drug development process needs extensive collaborations with internal & external stakeholders, co-ordination with cross functional teams like R&D, QA, clinical research, safety, manufacturing, supply chain, marketing, and so on. At every phase of development process, ...
By DDi LLC
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CSX-1004: A Promising Canidate in the Fight Against the Fentanyl Crisis
The opioid crisis in the United States is a devastating public health issue, with over 70,000 overdose deaths annually, largely driven by the highly potent synthetic opioid fentanyl. The urgency to address this crisis has spurred the development of innovative therapies to prevent and reverse fentanyl overdoses. In this blog, we will explore the groundbreaking preclinical work on CSX-1004, a fully ...
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Betting big on quantitative neurobiomarkers
Introducing Beacon Biosignals: a neurotechnology company founded to develop machine learning-enabled EEG neurobiomarkers and accelerate precision medicine for any disease state affecting the brain Founded by MD/PhDs and engineers from Harvard and MIT, Beacon is propelled by the vision of a computing platform designed to scale the interrogation of large brain datasets with unprecedented ...
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Clinical CRISPR Success Demonstrates Need for Quality Control
The Clinical CRISPR Successes Are Stacking Up. But Where’s the Emphasis on Quality Control? In mid-September, Intellia released some promising data on two of their CRISPR-based therapeutics. These results are a significant milestone for genome editing and validation of its effectiveness in the clinic. However, the safety of CRISPR-based therapeutics has been a major concern and part of a ...
By CRISPR QC
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Preclinical and safety studies of V-1 Immunitor
The safety of V-1 Immunitor (V1) has been investigated. L929; BHK; Vero; Caco-2 and CEM-SS cells have not shown cytotoxicity even at 10 mg/ml dose. Ames' mutagenicity and micronucleus genotoxicity tests came out negative at 50 mg and 2000 mg/kg doses in Salmonella and bone marrow of IRC mice. Acute and chronic dosing of V1 to Swiss albino mice and Spague Dawley rats failed to cause any deaths. ...
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Biorep Innovation Partner to COVID-19 Stem Cell Therapy Trial
After a lightning round of proposals and reviews, an international team of scientists led by Dr. Camillo Ricordi was granted immediate FDA authorization for a 24-patient clinical trial to test the safety and exploratory efficacy of umbilical cord-derived mesenchymal stem cells (UC-MSCs) to block the life-threatening lung inflammation that accompanies severe cases of COVID-19. The therapy uses ...
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Pilot Validation of a New Wireless Patch System as an Ambulatory, Noninvasive Tool That Measures Gut Myoelectrical Signals: Physiologic and Disease Correlations
Abstract Background and aims: Limited means exist to assess gastrointestinal activity in a noninvasive, objective way that is highly predictive of underlying motility disorders. The aim of this paper is to demonstrate the feasibility of recording myoelectric gastrointestinal activity by cutaneous patches and to correlate myoelectric signals with gastrointestinal function in various clinical ...
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Matrix Gemini Lims at work in Cancer research trials case study
Executive Summary The Roy Castle Lung Cancer Foundation (RCLCF) is a UK wide charity, dedicated to the defeat of lung cancer. It funds basic science research, tobacco control initiatives and work in lung cancer patient information, support and advocacy. RCLCF works towards defeating lung cancer through research, campaigning and education and gives practical and emotional support for patients and ...
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The Effects of Excipients on Pharmaceutical Preparation
Excipients are very important for pharmaceutical preparations. It can be said that without excipients, there will be no pharmaceutical preparations, let alone different pharmaceutical dosage forms such as powders, granules, tablets, oral liquids or injections. When the drug and the appropriate excipients are combined into a specific dosage form, the drug would become safer, more stable and more ...
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