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Filter by:In general, the toxicity of radiation therapy and chemotherapy exhibits a strong dose-response relationship. However, patients receiving similar doses still exhibit a range of toxicity responses due to a variety of factors, including comorbid conditions, disease (cancer) specific factors, and inter-individual genetic variation. A very small percentage of patients experience side effects that are either extremely severe or extremely mild compared to the majority of patients for the dose of radiation or chemotherapy given. Currently, the reasons for this are not entirely clear, but likely relate to patient specific factors such as immune response, cell/tissue repair capacity and other factors that fundamentally rely on rare genetic variations at loci involved in these responses. For example, patients with homozygous deletions in DNA damage response genes such as ATM are uniquely sensitive to DNA damaging agents. Many patients with severe, homozygous mutations in such genes have other sequela that lead to medical recognition of the syndrome prior to therapy. The investigators hypothesize that patients with unusually severe toxicity from therapy that do not exhibit classical signs of homozygous mutation syndromes are heterozygous for nonfunctional or hypofunctional alleles at these loci, such that the defect is only uncovered under the relatively acute, severe stress on that pathway by radiation or chemotherapy. Conversely, patients with very mild reactions could exhibit rare variants/combinations of variants that make them uniquely resistant to chemotherapy or radiotherapy toxicity. The purpose of the study is to better understand these mechanisms with the eventual goal of developing predictive markers that will allow us to help individually tailor cancer therapy is in future patients. Will accomplish these goals by studying a variety of factors from a single vial of blood. These will include circulating proteins and hormones, circulating cells and the levels and sequences of white blood cell DNA or RNA using a variety of techniques including but not limited to determination of cytokine/hormone levels, proteomic analysis, immunocytochemical assays, whole exome sequencing and qPCR.
The purpose of this study is to find out if special blood tests and imaging scans can help evaluate the effects of the radiation the patient receives as part of standard treatment. The patient will undergo either stereotactic or conventional radiation treatment as determined by the treating doctor. Previous evidence suggests that blood flow to tumors is affected by the amount (dose) of radiation that it receives. This effect may be seen as soon as 1-2 hours after the radiation is given. This study will evaluate if these changes can be seen and measured by performing a special type of scan called Intravoxel Incoherent Motion (IVIM) diffusion-weighted Magnetic Resonance Imaging (MRI) and a blood test. IVIM MRI is a research exam which is similar to a standard MRI exam, with only a slight difference in the technical parameters used to acquire the images.
This is a prospective registry evaluating the safety of performing magnetic resonance (MRI) scans on patients who have cardiac implanted electronic devices (CIEDs). This includes pacemakers and implantable cardioverter defibrillators (ICDs). This is not a a new device approval or new MRI scanner approval, only for a registry of patients who need to have an MRI scan who already have an FDA approved CIED that is not currently labeled for use in conjunction with an MRI scan. This registry is very similar to the previously approved MagnaSafe Registry that is now closed to new enrollment.
In this study the investigators measure and optimize the patients waiting time in the preanesthetic assessment by integrating an interactive mobile device. The aim of this study is to observe whether the patients mean waiting-time is reduced by the use of a special mobile application (Anaest-App) and, as a result , raises patient-satisfaction.
Metformin is being compared to exercise and diet modifications. The researchers are interested in learning if the addition of metformin to lifestyle modifications is more helpful in treating the condition or disorder. Although metformin is FDA approved to treat type 2 diabetes, it is not FDA approved for the treatment of Non-alcoholic fatty liver (NAFLD) and is considered investigational for the purpose of this study.
The purpose of this prospective interventional study is to assess whether adjunctive verteporfin photodynamic therapy (PDT) is effective for the treatment of persistent disease activity in neovascular age-related macular degeneration (NV AMD), as compared to anti-VEGF therapy (aflibercept) alone. This study will enroll individuals with NV AMD who have persistent disease activity in spite of either loading dose (initial 3-5 anti-VEGF treatments) or maintenance (established course) anti-VEGF therapy to determine whether PDT can improve disease activity, facilitate sustained visual acuity gains, and decrease burden of frequent anti-VEGF treatments for affected patients. Risks of study are related to treatment with study drugs: intravenous verteporfin, intravitreal triamcinolone acetonide, and intravitreal aflibercept. All have been studied extensively in clinical trials and are established treatments used routinely in NV AMD. Adverse events will be monitored by the principal investigator and study team.
This phase Ib trial studies the safety and best dose of binimetinib when given in combination with docetaxel in treating patients with previously treated, stage IV non-small cell lung cancer. Binimetinib and docetaxel may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Patients who undergo bone marrow transplant for different types of cancer are exposed to many treatments such as steroids and whole body radiation. These treatments make the transplant possible but also make their bones weaker and more prone to fractures which can be a source of significant disability and decreased quality of life for cancer survivors. Our trial will investigate whether giving one dose of Zoledronic acid (a commonly used drug given to preserve bone mass in osteoporosis) before bone marrow transplant can protect from the bone loss caused by the transplant procedures. The investigators are also interested in studying the complex interactions of bone, muscle and fat which are greatly affected after bone marrow transplant.
This clinical study is a phase 1 study which carried out to to evaluate the safety, pharmacokinetics and tolerability of multiple intravitreal injections of BCD-021(bevacizumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) when used in patients with neovascular wet age-related macular degeneration.
The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) [after daily administration for 7 days] and safety [after daily administration for 8 weeks] of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with acid-related diseases.