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NCT ID: NCT03899337 Recruiting - Richter Syndrome Clinical Trials

A Trial of CHOP-R Therapy, With or Without Acalabrutinib, in Patients With Newly Diagnosed Richter's Syndrome

STELLAR
Start date: July 23, 2019
Phase: Phase 2
Study type: Interventional

The STELLAR trial will assess the effect of acalabrutinib taken in combination with CHOP-R compared to taking CHOP-R alone in patients with newly diagnosed Richter's Syndrome (RS). It will also be a platform to test other new drugs that show potential for treating RS. Chronic lymphocytic Leukaemia (CLL) is the most common blood cancer in adults, usually in their 70s or older. In a few patients, CLL can transform from a slow-growing cancer into an aggressive lymphoma called Richter's Syndrome. RS is very difficult to treat and patients have a short life-expectancy - usually a few months after diagnosis. Treatment for Richter's Syndrome in the UK is CHOP (four chemotherapy drugs) plus rituximab ('R' - an antibody treatment). The CHOP-R treatment is given as a standard of care for RS but has limited benefit - it is often temporary to extend life. Richter's Syndrome returns in most patients who then die from this disease. The STELLAR trial will investigate if a new drug called acalabrutinib, which is effective used by itself in patients with relapsed CLL and also some with Richter's Syndrome, will improve outcomes for newly diagnosed patients with RS. Acalabrutinib blocks a protein in CLL which can stop the cancer growing. Participants who have Richter's Syndrome and are suitable for CHOP-R will be recruited by specialised hospitals across the UK. People with another cancer, heart problems, or recent stroke cannot take part. Participants will have a lymph node biopsy, 3-4 bone marrow biopsies, blood samples, and PET-CT and CT scans. CHOP-R is given in a hospital every three weeks up to 6 times. All participants will receive CHOP-R; half will also receive acalabrutinib. When treatment with CHOP-R ends the patients who had acalabrutinib can continue to take it; patients who had CHOP-R alone may have acalabrutinib if their Richter's Syndrome returns after CHOP-R.

NCT ID: NCT03896269 Recruiting - Clinical trials for Refractory Chronic Myelomonocytic Leukemia

CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Start date: May 14, 2019
Phase: Phase 1
Study type: Interventional

This phase I trial studies best dose and side effects of liposome-encapsulated daunorubicin-cytarabine (CPX-351) and how well it works in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back or has not responded to treatment. Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

NCT ID: NCT03894527 Recruiting - Obesity Clinical Trials

Impact of Acute Exercise on Vascular Insulin Sensitivity in Metabolic Syndrome

Start date: February 18, 2019
Phase: N/A
Study type: Interventional

Obesity is an independent risk factor for type 2 diabetes and cardiovascular disease. The increased prevalence of obesity worldwide is a major concern among the scientific and medical communities. Insulin resistance is a common factor associated with obesity, metabolic syndrome, hypertension, and type 2 diabetes. Individuals affected by these conditions often experience endothelial dysfunction as well. Insulin resistance provides a key link between metabolic syndrome risk factors and vascular disease. Development of strategies aimed at preventing vascular dysfunction and future disease caused by metabolic disturbances is needed. Although the relationship between obesity and various diseases is well known, the acute effects of insulin on vascular function in obese individuals have yet to be fully determined. Additionally, the effects of acute exercise on insulin-stimulated endothelial function are unknown. Exercise may be an effective and potent treatment that protects against endothelial dysfunction, insulin resistance, and future cardiometabolic disease commonly present with obesity. However, less attention has been placed on vascular insulin sensitivity. The purpose of this study is to test the hypothesis that a single bout of exercise increases insulin-stimulated blood flow at the macro- and micro-vasculature level in obese individuals with metabolic syndrome to similar levels as healthy obese control. Our laboratory has available non-invasive methods to quantify vascular function and the gold-standard technique for assessing insulin sensitivity (euglycemic-hyperinsulinemic clamp). The investigators will assess vascular function (flow-mediated dilation, post-ischemic flow velocity and contrast-enhanced ultrasound) as well as arterial stiffness (augmentation index and pulse wave velocity) before and at the end of the clamp protocol performed the morning following a bout of exercise and a control (no-exercise) condition in 1) metabolic syndrome and 2) obese adults. If our hypothesis is sustained, it will suggest that a key role of the vasculature exists in regulating insulin following exercise and will provide insight into the link between the vasculature, obesity, metabolic syndrome and cardiovascular disease and may confer decreased risk for cardiometabolic disease.

NCT ID: NCT03886662 Recruiting - Clinical trials for Myelodysplastic Syndromes

A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)

Start date: April 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to test the safety and efficacy (benefits) of an investigational drug LB-100, for treatment of myelodysplastic syndromes. LB-100 has previously been administered to patients with various solid tumors. In this study, LB-100 will be administered as an intravenous infusion over 120 minutes. This study will be conducted in 2 phases. In phase Ib, escalating doses of LB-100 will be administered to patients to study the safety and to determine a safe dose of LB-100. In phase 2, patients will be administered LB-100 at the dose that was found to be safe in phase Ib. The efficacy (benefits) and safety of LB-100 will be determined in this phase of the study.

NCT ID: NCT03884829 Recruiting - Clinical trials for Myelodysplastic Syndromes

A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS

Start date: March 25, 2019
Phase: Phase 1
Study type: Interventional

A Phase I Pharmacologic Study of CYC140, a polo-like kinase 1 inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes

NCT ID: NCT03871192 Recruiting - Facet Joint Pain Clinical Trials

Injections in the Diagnosis and Treatment of Lumbar Facet Syndrome

Start date: August 15, 2018
Phase: N/A
Study type: Interventional

In suspected facet joints pain, it is recommended to perform nerve blocks to establish the diagnosis with positive results being and indicator of successful of most permanent treatment of facet pain by rhizolysis. Nevertheless, the usefulness of intraarticular joint injection for diagnosis and prediction of successful neurolysis have been scarcely studied. The main purpose of this trial is to compare both methods, nerve block and intra articular injection, in diagnosis and treatment of facet joints pain.

NCT ID: NCT03865589 Recruiting - Clinical trials for Stem Cell Transplant Complications

Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

To perform an receiver operating characteristic (ROC) analysis, define a threshold and quantify the sensitivity and specificity of US SWE for risk stratification of patients into three categories as defined by the European Bone Marrow Transplant (EBMT) adult and pediatric criteria: no sinusoidal obstruction syndrome (SOS), mild to moderate SOS, and severe to very severe SOS. Secondarily, the investigators would also like to quantify the temporal relationship between US SWE changes and SOS diagnosis according to various clinical criteria (Modified Seattle, Baltimore, EBMT consortium).

NCT ID: NCT03864068 Recruiting - Insulin Resistance Clinical Trials

Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

INSUPP-PCOS
Start date: January 24, 2020
Phase: Phase 2
Study type: Interventional

To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).

NCT ID: NCT03863327 Recruiting - Clinical trials for Acute Coronary Syndrome

EKG Criteria and Identification of Acute Coronary Occlusion

Start date: May 1, 2018
Phase:
Study type: Observational

The objective of this research study is to test the accuracy of preexisting criteria versus expert interpretation for the diagnosis of acute coronary occlusion (major heart attack due to a completely blocked blood vessel). If our hypothesis proves to be true, this would provide a significant improvement in the care for patients who present to the hospital with possible symptoms of coronary ischemia (symptoms due to lack of blood flow to the heart). The primary analysis will be designed as a multi-center, retrospective case-control study.

NCT ID: NCT03863171 Recruiting - Clinical trials for Ocular Ischemia Syndrome

Early Diagnosis for Ocular Ischemia Syndrome Using Arterial Spin Labeling Magnetic Resonance Imaging Technique

Start date: March 1, 2019
Phase:
Study type: Observational

1. To evaluate ocular blood perfusion status and the possibility of craniocerebral vascular lesions of patients with ocular ischemia syndrome (OIS) using arterial spin labeling (ASL) magnetic resonance imaging technique. 2. To evaluate the specificity, sensitivity and accuracy of arterial spin labeling (ASL) magnetic resonance imaging technique in OIS diagnosis, compared with the traditional routine examination method.