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Discover 23,284 clinical trials near Maryland. Find research studies in your area.
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NCT01819766
This study aims to determine the performance of the Exact IBD-ACRN surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease (IBD). Patients with an IBD diagnosis for at least eight years or diagnosis of primary sclerosing cholangitis (PSC) and who are eligible for CRC screening are eligible to participate in this study. Enrolled subjects will collect a stool sample for the Exact IBD-ACRN surveillance test. Subjects must have undergone colonoscopy no more than 90 days prior to enrollment and will undergo colonoscopy or surgical intervention within 120 days of enrollment. Tissue diagnosis of CRC will be established by histopathologic examination.
NCT01838642
Background: * Medullary thyroid cancer (MTC) represents 5% of thyroid cancers and presents as a hereditary (25% of cases) or sporadic (75% of cases) neuroendocrine malignancy. * MTC arises from the parafollicular C-cells of the thyroid. * Germline mutations in the rearranged during transfection (RET) proto-oncogene occur in virtually all of hereditary MTC cases, and somatic RET mutations occur in 50% of sporadic cases. * Drugs targeting RET kinase such as vandetanib and cabozantinib have shown efficacy in the treatment of advanced or metastatic MTC, however, more effective RET inhibitors are needed for previously untreated patients as well as patients who have become refractory to other molecular targeted therapeutics (MTTs). * Ponatinib, a drug that is Food and Drug Administration (FDA) approved as a therapy for chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), is a potent inhibitor of RET kinase. Primary Objective: -To determine the objective overall response rate (complete response \[CR\] + partial response \[PR\] by Response Evaluation Criteria in Solid Tumors (RECIST) to ponatinib in the treatment of patients with advanced or metastatic MTC previously treated with cabozantinib and vandetanib who: 1) have tumors with RET mutations and 2) have tumors without RET mutations. Eligibility: * Patients must have histologically confirmed, unresectable, locally advanced or metastatic MTC, with measurable disease by RECIST criteria. * Patients must have disease amenable to biopsy and be willing to undergo biopsy for molecular analysis, and also have adequate archival material from their thyroidectomy or from a tumor biopsy obtained prior to beginning any systemic therapy. * Patients must have failed or been intolerant to prior treatment with both cabozantinib and vandetanib. * The last dose of prior systemic therapy must be more than 28 days prior to the first dose of ponatinib * Radiation therapy is permitted if the last treatment was received more than 28 days prior to the first dose of ponatinib. Design: * Open label phase II trial with 2 treatment groups: * RET mutation positive MTC, previously treated with vandetanib and cabozantinib * RET mutation negative MTC, previously treated with vandetanib and cabozantinib * Patients will receive ponatinib 30 mg orally daily until disease progression or until the development of intolerable side effects. * Tumor response will be assessed by RECIST 1.1 criteria at 8 weeks and then every 12 weeks thereafter. After one year on study, tumor response will be assessed every 16 weeks. * Patients will have a biopsy of their MTC for molecular analysis prior to initiating treatment with ponatinib. Patients will also have a biopsy of their MTC at the time of tumor progression, should that occur.
NCT02026752
The objective is to obtain plasma samples from Human Immunodeficiency Virus Type 1 (HIV-1) infected individuals that have viral loads across the dynamic range of the Aptima HIV-1 assay. The plasma samples will be tested in a method comparison study to support the approval of the Aptima HIV-1 assay on Gen-Probe's Panther testing system. The objective of the method comparison study is to evaluate the clinical utility of the Aptima HIV-1 assay by comparing the results to the FDA-licensed COBAS assay (Roche Molecular Systems, Inc., Branchburg, New Jersey) in plasma samples that have viral loads across the dynamic range of the Aptima HIV-1 assay.
NCT01800968
The primary objective is to test the hypothesis that, compared with placebo, therapy with Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge period will be associated with greater clinical stability at six months as assessed by a composite clinical endpoint.
NCT01120561
This is a multicenter, open-label, single-arm, expanded access study designed to provide T-DM1 to patients with HER2-positive locally advanced or metastatic breast cancer and to evaluate the safety and efficacy of T-DM1 administered by intravenous (IV) infusion.
NCT01165684
This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.
NCT01128894
This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.
NCT00057785
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer.
NCT00003901
RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment. PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.
NCT00099229
This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.
NCT01081834
The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
NCT01044186
The purpose of this open-label, non-comparative, multi-center protocol was to further evaluate safety and to provide treatment with ICL670 to patients who had or were at risk of life threatening complications due to transfusional iron overload with a documented inability to tolerate any of the commercially available iron chelators due to severe toxicity rendering continued therapy either impossible or hazardous. Patients who were also ineligible for all on-going registration trials with ICL670 were included in the study. In exceptional cases, patients with a degree of iron overload which was not immediately life-threatening and who were ineligible for the registration trials were also enrolled provided they had a well-documented, sound justification for alternative chelation therapy.
NCT02166125
The purpose of this prospective registry is to assess long term data on efficacy, safety and clinical outcome of endoscopic placement of suture(s) and approximation of soft tissue within the Gastrointestinal tract for various GI tract disorders. The registry will evaluate technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this research study.
NCT00358150
Gaucher disease is a genetic disease that results in a deficiency of an enzyme acid beta-glucosidase, also known as glucocerebrosidase. This enzyme is needed to digest a substrate (lipid) called glucosylceramide and, to a lesser degree, glucosylsphingosine. In participants with Gaucher disease, the liver, spleen, bone marrow and brain show increases in lipid concentration, specifically in cells derived from the monocyte/macrophage system. Eliglustat tartrate (Genz-112638) is an oral drug that may regulate the Gaucher disease process by decreasing the synthesis of glucosylceramide. The primary objective of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of eliglustat tartrate, administered as an oral dose of either 50 milligram (mg) twice daily (BID) or 100 mg BID, to men and women with Gaucher disease Type 1 for 52 weeks.
NCT01220271
The purpose of this trial is to show proof of concept that by blocking the Transforming Growth Factor-beta signaling pathway in patients with Glioblastoma, there will be clinical benefit. Phase 1b: To determine the safe and tolerable dose of LY2157299 in combination with radiochemotherapy with temozolomide for Phase 2 in patients with glioma eligible to receive radiochemotherapy with temozolomide (e.g. newly diagnosed malignant glioma World Health Organization Grade III and IV). Phase 2a: To confirm the tolerability and evaluate the pharmacodynamic effect of LY2157299 in combination with standard radiochemotherapy in patients with newly diagnosed glioblastoma.
NCT00397930
RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors. PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.
NCT02144220
The primary objective of this study is to evaluate the feasibility, efficacy and the value of providing care to individuals with Parkinson disease directly into their homes. The specific aims are: 1. To demonstrate the feasibility of conducting remote evaluations of patients with Parkinson disease nationally; 2. To measure the impact of remote care on each patient's ability to improve his or her quality of life (QoL) and better manage his or her Parkinson disease; and 3. To assess the long-term acceptability to patients in receiving ongoing care remotely via telemedicine.
NCT01556204
The objective of this study is to conduct a prospective randomized controlled trial of robotic-assisted versus conventional laparoscopy for the treatment of endometriosis.
NCT00986414
This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.
NCT01127750
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.