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NCT ID: NCT02864368 Terminated - Glioblastoma Clinical Trials

Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens

PERFORMANCE
Start date: December 7, 2016
Phase: Phase 1
Study type: Interventional

Newly diagnosed glioblastoma (GBM) patients with complete or partial surgical resection who were CMV seropositive patients were eligible to enroll on this trial. Patients were enrolled following standard of care chemoradiation and prior to initiation of post-radiation cycles of temozolomide (TMZ) provided they met all eligibility criteria. All eligible patients received a tetanus-diphtheria (Td) vaccination. Patients enrolled on study were randomized to receive either standard TMZ or dose-intensified TMZ (excluding the safety cohort who only received standard TMZ). All patients received a pre-conditioning injection of tetanus on day 22 of the first post-radiation cycle of TMZ. The following day, patients received the first of 3 intradermal (i.d.) injections of the study drug cytomegalovirus peptide (PEP-CMV), which contained either a combination of Component A and Component B or Component A only depending upon when they enrolled on study. Vaccines #2 and #3 will be given at 2 week intervals. Patients who were O[6]-methylguanine-DNA methyltransferase (MGMT) unmethylated received one adjuvant cycle of the TMZ regimen according to their assigned TMZ arm. Patients who were MGMT methylated or whose methylation status was inconclusive continue with up to 12 cycles of TMZ. After the completion of a patient's last TMZ cycle, vaccines continued every 4-6 weeks for a maximum number of 20 vaccines (unless tumor progression occurred). The study ended prematurely due to lack of funds. The preliminary results suggest that the vaccine may be capable of generating an immune response.

NCT ID: NCT02864355 Terminated - Esophageal Cancer Clinical Trials

Does Perioperative Goal Directed Therapy Using Flotrac Improve Outcomes in Esophagectomy Patients

Start date: June 2016
Phase: N/A
Study type: Interventional

The objective of this prospective, randomized controlled study is to ascertain whether the perioperative use of the FloTrac device to guide fluid and vasopressor management during esophagectomy improves patient outcomes. The primary outcome is cardiopulmonary complications; however, the secondary outcome of decreasing patient morbidity (acute renal injury, anastomotic leak, and overall length of both ICU (intensive care unit) and hospital stay.

NCT ID: NCT02864316 Terminated - Clinical trials for Solid Tumors Induced by Prior Radiation Exposure

Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure

Start date: December 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Nivolumab is effective in the treatment of radiation-induced solid tumors.

NCT ID: NCT02864290 Terminated - Clinical trials for Acute Myeloid Leukemia

A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)

Start date: November 10, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of ASP1235 (AGS62P1) given at three dosing schedules (Schedule A, every three weeks [Q3W] or Schedule B, every other week of a 4 week cycle [Q2W] or Schedule C once a week for 3 weeks of a 4 week cycle) in subjects with acute myeloid leukemia (AML) and determine the maximum tolerated dose (MTD). In addition, this study will assess the pharmacokinetics (PK), the immunogenicity and the anti-leukemic activity of ASP1235 (AGS62P1).

NCT ID: NCT02863029 Terminated - Obesity Clinical Trials

Defining the Role of the Gut Microbiome in Mediating the Effects of Obesity on Intestinal Stem Cells

Start date: January 2017
Phase: N/A
Study type: Interventional

New studies are revealing how a high-fat diet could be making the cells of the intestinal lining more likely to become cancerous. The investigators would like to study how obesity influences growth of intestinal stem cells, which could then trigger intestinal tumors. The investigators are proposing a Pilot Study of 20 subjects (comprised of 10 participants from each of two different BMI categories: 20-25 and 35 & above), who will be asked to provide blood, stool, & urine samples, undergo a flexible sigmoidoscopy, and complete food frequency questionnaires

NCT ID: NCT02862691 Terminated - Toothache Clinical Trials

Percocet vs. Bupivicaine for Toothaches in the ED

Start date: August 1, 2016
Phase: Phase 2
Study type: Interventional

The goal of this study is to compare the speed and adequacy of pain relief in Emergency Department patients with a toothache after an oral analgesic or a local anesthetic administered as a nerve block or by local infiltration.

NCT ID: NCT02862574 Terminated - Clinical trials for Rheumatoid Arthritis

Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis

Start date: December 15, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of andecaliximab (GS-5745) versus placebo as an add-on therapy to a tumor necrosis factor (TNF) inhibitor and methotrexate in adults with moderate to severe rheumatoid arthritis (RA).

NCT ID: NCT02861495 Terminated - Humeral Fractures Clinical Trials

Humeral Compression/Distraction Device

Start date: September 30, 2016
Phase: N/A
Study type: Interventional

The proposed study of humeral shaft fractures in adults will examine outcomes in patients treated with the Humeral Trauma Nail System to treat displaced humeral shaft fractures (displaced OTA code 12A, B, or C), nonunions, or malunions. The device to be studied uses an internal gear system controlled wirelessly by rare earth magnets, which typically offers distraction for lengthening. In the humerus however, during the treatment of acute fractures, this percutaneously inserted nail can also offer compression during the healing process, thereby negating the effect of gravity, which may in turn lead to a faster and more consistent rate of union. Furthermore, in cases of slower healing the dynamic properties of the nail may employ an "accordion technique" (alternating compression-distraction, a feature unique to this implant.

NCT ID: NCT02860130 Terminated - Acute Kidney Injury Clinical Trials

Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)

Start date: September 27, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18 as the anticoagulant will be compared to patients who receive CRRT treatment with no anticoagulation.

NCT ID: NCT02859428 Terminated - Clinical trials for Hereditary Spastic Paraplegia

Disease Natural History and Biomarkers of SPG3A, SPG4A, and SPG31

Start date: November 18, 2016
Phase:
Study type: Observational

Background: Hereditary spastic paraplegia (HSP) usually progresses slowly. Researchers want to learn more about how its symptoms change over time. They want to look for changes in the blood and cells of people with the most common forms of HSP that might allow them to better understand the disease. Objectives: To learn more about common forms of hereditary spastic paraplegia and find out how it progresses over time. Eligibility: People age 7 and older with SPG3A, SPG4A, or SPG31 Design: Participants will have 1 two-hour visit each year for up to 5 years. At 1 visit, adult participants may have a skin biopsy. An area of skin will be numbed then a tool will remove a small piece of skin. At all visits, all participants will have a physical exam and blood drawn. At all visits, participants will do a few tasks like walking quickly and climbing stairs. Participants can give permission for their skin cells, DNA samples, and data to be used in other studies. The samples and data will have no identifying information.