22 Clinical Trials for Various Conditions
A large number of patients are diagnosed with low risk ACS, and these individuals are at significant cardiovascular risk. Though guidelines recommend stress testing to manage low risk ACS patients, evidence supporting this recommendation is not based on trials examining this population. A well-designed, randomized trial is warranted to determine if stress testing is useful in managing low risk ACS. If medical therapy alone is equivalent as the investigators hypothesize, healthcare expenditures could be reduced and patients may not be exposed to the harms associated with more invasive cardiac testing such as coronary angiography.
Graft-versus-host disease (GVHD) is treated with high doses of systemic steroids which can lead to serious complications. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD). This study will test whether patients with low risk GVHD can be successfully treated without steroids. Patients who participate with this study will be treated with itacitinib instead of steroids. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment.
The standard treatment for acute graft-vs-host disease (GVHD) is to suppress the activity of the donor immune cells using steroid medications such as prednisone. Although most GVHD, especially in children, responds well to treatment, sometimes (around 1/3 of the time) there is either no response to steroids or the response does not last. In those cases, the GVHD can become dangerous and even life-threatening. Unfortunately, doctors cannot predict who will have a good response to treatment based on symptom severity or initial response to steroids. As a result, nearly all children who develop GVHD are treated with long courses of high dose steroids even though that means many patients receive more treatment than they probably need. Steroid treatment can cause short-term complications like infections, high blood sugar, high blood pressure, muscle weakness, depression, anxiety, and problems sleeping and long-term complications like bone damage, cataracts in the eyes, and decreased growth. The risk of these complications increases with higher doses of steroids and longer treatment. It is important to find ways to decrease the steroid treatment in patients who do not need long courses. The doctors conducting this research have developed a blood test (GVHD biomarkers) that predicts whether a patient will respond well to steroids. The study team found that children who have low GVHD biomarkers at the start of treatment and for the first two weeks of treatment have a very high response rate to steroids. In this study, the study team will monitor GVHD symptoms and biomarkers during treatment and taper steroids quickly in patients who have GVHD that is expected to respond very well to treatment. The study team will assess how many patients respond well to lower steroid dosing and what steroid complications develop. The study team will also use surveys to obtain the patient's own assessment of their quality of life (down to age 5 years).
The purpose of this study is to examine the degree to which pulmonary embolism (clot) can be dissolved when treated with a very low dose of a systemic thrombolytic drug (clot buster) along with standard anticoagulant therapy as compared to the standard of care anticoagulant therapy alone.
This study will test the safety and effectiveness of two vaccines on slowing disease progression, improving blood counts, reducing the need for transfusions of blood and platelets, or achieving remission in patients with myelodysplastic syndrome (MDS, also known as myelodysplasia), acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). The vaccines consist of peptides (parts of proteins) found in MDS, AML and CML stem cells, combined with a substance called "MontanideTM". They are administered with granulocyte- macrophage colony- stimulating factor (GM-CSF). The Montanide and the GM-CSF help the immune system respond to the vaccines. People 18 years of age or older with MDS, AML or CML may be eligible for this study. Participants receive six injections of the vaccines, one dose every other week for a total of 10 weeks. The injections are given in the upper arm, upper leg, or abdomen. A separate injection of GM-CSF is given in the same area as the vaccine injections. Subjects are observed for 2 hours after the first vaccination and at least 30 minutes after each subsequent vaccination for allergic reactions. In addition to the vaccination, subjects undergo the following: * History and physical exam, chest x-ray, blood tests and bone marrow aspirate and biopsy before starting the vaccinations. * Safety monitoring during vaccine administration (every other week for 10 weeks) with blood tests and check of vital signs. * Follow-up safety monitoring (weeks 12 and 16) with blood tests every visit, chest x-ray at week 12 and bone marrow biopsy visit 16.
The purpose of this study is to evaluate if the implementation of quantitative pretest probability assessment will significantly reduce the unnecessary use of the intra-emergency department chest pain center. Specifically, the study will examine whether the PREtest Consult acute coronary syndrome (ACS) pretest probability assessment system can significantly reduce the use of chest pain unit evaluation in very low risk emergency department (ED) patients, can safely discharge patients with a pretest probability ≤ 2.0%, can reduce unnecessary procedures and lower hospital costs and will examine patient satisfaction of patients with whom pretest probability assessment was used compared to those with whom it was not used. The researchers hypothesize that patients in the control group of the study will have statistically significant reductions in mean time spent in the emergency department, mean charges billed to the patient or their insurance carrier, hospital length of stay, mean number of procedures or tests performed without a statistically significant change in patient satisfaction or adverse outcome.
The purpose of this study is to determine the effectiveness of the HEART Pathway, a clinical decision aid for the care of patients with chest pain, in a "real-world" clinical setting. This will be accomplished through the building of a transformative collaboration between research, education, and health systems operations to more effectively and efficiently provide patient care.
Primary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent adverse events (TEAEs), injection-site reactions (ISRs), and hypersensitivity reactions Phase 1/2 (Virologic Efficacy) • Evaluate the virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy compared to placebo, as measured by time-weighted average (TWA) change from baseline in viral load through day 7 Phase 1/2/3 (Clinical Efficacy) • Evaluate the clinical efficacy of REGN14256+imdevimab compared to placebo, as measured by COVID-19 symptoms resolution Secondary Objectives Phase 1 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by treatment-emergent serious adverse events (SAEs) Phase 2 and Phase 3 (Safety and Tolerability) • Evaluate the safety and tolerability of REGN14256+imdevimab and REGN14256 monotherapy, as measured by TEAEs, ISRs, hypersensitivity reactions, and SAEs Phase 1, Phase 2, and Phase 3 (Virologic Efficacy, Drug Concentration, and Immunogenicity) * Evaluate additional indicators of virologic efficacy of REGN14256+imdevimab and REGN14256 monotherapy * Characterize the concentration-time profile of REGN14256 administered in combination with imdevimab or alone as a monotherapy * Assess the immunogenicity of REGN14256 administered in combination with imdevimab or alone as a monotherapy
The goal of this clinical trial is to find out whether fasting is necessary before urgent inpatient cardiac catheterizations. For patients presenting with urgent heart-related pain or even mild heart attacks, researchers want to know whether eating and drinking before their procedure improves comfort without raising the risk of complications. The study will answer: * Does eating and drinking before the procedure improve patient comfort? * Does it increase the risk of adverse events like vomiting, aspiration (food or liquid entering the lungs), breathing problems, or death, etc? Participants will be randomly assigned to either: * A standard fasting group (no food for 6 hours, no clear liquids for 2 hours), or * A no-fasting group (able to eat and drink as usual). Patients will complete brief surveys before the procedure to assess comfort and satisfaction. Researchers will also review medical records weekly and 30 days later to monitor for safety outcomes.
Coronary Computed Tomography Angiogram (CCTA) is a non-invasive imaging modality that has high sensitivity and negative predictive value for the detection of coronary artery disease (CAD). The main limitations of CCTA are its poor specificity and positive predictive value, as well as its inherent lack of physiologically relevant data on hemodynamic significance of coronary stenosis, a data that is provided either by non-invasive stress tests such as myocardial perfusion imaging (MPI) or invasively by measurement of the Fractional Flow Reserve (FFR). Recent advances in computational fluid dynamic techniques applied to standard CCTA are now emerging as powerful tools for virtual measurement of FFR from CCTA imaging (CT-FFR). These techniques correlate well with invasively measured FFR \[1-4\]. The primary purpose of this study is to evaluate the incremental benefit CT-FFR as compared to CCTA in triaging chest pain patients in emergency settings who are found to have obstructive CAD upon CCTA (generally \>= 30% stenosis). Invasive FFR and short term clinical outcomes (90 days) will be correlated with each diagnostic modality in order to evaluate positive and negative predictive value of each. Patients will undergo a CCTA, as part of routine emergency care. If the patient consents to participate in the study, the CCTA study will be assessed by Toshiba Software, to provide a computerized FFR reading, based on the CCTA study. If the noninvasive FFR diagnosis indicates obstructive disease, the patient will undergo cardiac catheterization with invasive FFR. As CCTA utilization increases, the need to train additional imaging specialists will increase. This study will assess the capability of FFR-CT to enhance performance on both negative and positive predictive value for less experienced readers by providing feedback based on CT-FFR evaluation. If the use of CT-FFR improves accuracy of CCTA, as compared to the gold standard, (Invasive FFR), use of CT-FFR can potentially enhance performance for less experienced readers.
This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways and different doses may kill more cancer cells..
Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a pragmatic, cluster randomized trial. The first approach is to provide PCPs with information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines. The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP. The 1,860 patients expected to be enrolled at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study's primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period.
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).
The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.
The purpose of this study is to learn if 5'-Azacitidine will help to lower the risk of the disease coming back after a stem cell transplant in patients with MDS and AML. This study will also be looking at the side effects of this medicine. 5'-Azacitidine is an FDA approved drug for treatment of MDS and AML, as well as patients whose disease came back after transplant, where it helped going into remission. It is unclear if 5'-Azacitidine can prevent the disease from coming back after transplant. This study will help show if getting 5'-Azacitidine soon after transplant can lower the risk of your disease coming back.
This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given together with fludarabine phosphate and low-dose total-body irradiation followed by donor stem cell transplant and immunosuppression therapy in treating older patients with acute myeloid leukemia or high-risk myelodysplastic syndromes that cannot be controlled with treatment. Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them. Giving chemotherapy, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving radiolabeled monoclonal antibody therapy together with fludarabine phosphate and total-body irradiation before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
The goal of this clinical research study is to learn if cladribine given in combination with low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML or MDS. The safety of this drug combination will also be studied. Cladribine is designed to interfere with the cell's ability to process DNA (the genetic material of cells). It can also insert itself into the DNA of cancer cells to stop them from growing and repairing themselves. Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing and repairing themselves. Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die. This is an investigational study. Cladribine is FDA approved and commercially available for use in patients with hairy cell leukemia. Its use in patients with AML is investigational. Cytarabine is FDA approved and commercially available for use in patients with AML. Decitabine is FDA approved and commercially available for use in patients with MDS. Its use for patients with AML is investigational. Up to 160 patients will take part in this study. All will be enrolled at MD Anderson.
The goal of this clinical research study is to learn if omacetaxine given with cytarabine can help to control the disease in patients with AML or high-risk MDS. The safety of the study drugs will also be studied.
The purpose of this study is to determine the response rate of the combination of bortezomib and melphalan in patients with Acute Myelogenous Leukemia (AML) or high-risk Myelodysplastic Syndromes (MDS).
The goal of this clinical research study is to learn if clofarabine given in combination with cytarabine and decitabine can help to control the disease in patients with AML or MDS who are 60 years old or older. The safety of this treatment will also be studied.
The goal of this clinical research study is to learn if the combination of Gleevec (imatinib mesylate) and low doses of Cytarabine (ara-C) may help to control leukemia while causing fewer side effects than standard high dose chemotherapy.
The goal of this clinical research study is to study how effective treatments with clofarabine alone and clofarabine given in combination with ara-C are in the treatment of leukemia and high-risk myelodysplastic syndrome (MDS) in patients who are 60 years or older. The safety of these treatments will also be compared.