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NCT ID: NCT03024944 Withdrawn - Diabetes Mellitus Clinical Trials

TAU PET Imaging in Northern Manhattan Study of Metabolism and Mind

TAUPET
Start date: December 2017
Phase: Phase 2
Study type: Interventional

The purpose of this project is to study brain imaging of a substance called tau, which is found in brains of persons with Alzheimer's disease, using the Tau binder, 18F-THK-5351, for live imaging of tau in the brain. The main goal of this proposal is to study whether diabetes status (type 2 diabetes [referred to as diabetes] and pre-diabetes, compared with normal glucose tolerance [NGT]), is associated with increased tau accumulation in the brain, one of the culprits of Alzheimer's disease, in a community-based group of middle aged Caribbean-Hispanics with a mean age of 63 years. The investigators propose to conduct tau positron emission tomography (PET) imaging in 30 middle aged Hispanics.

NCT ID: NCT03024372 Withdrawn - Clinical trials for Arteriovenous Fistula

Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation

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

The purpose of this study is to investigate a promising strategy to improve maturation and patency rates following creation of AV fistulas and assess whether an anastomosis performed with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency than one performed with conventional suturing techniques.

NCT ID: NCT03024060 Withdrawn - Actinic Keratosis Clinical Trials

Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp

Start date: March 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.

NCT ID: NCT03021941 Withdrawn - Clinical trials for Type 1 Gaucher Disease

Pharmacokinetics, Pharmacodynamics And Safety Study Of Elelyso(tm) In Pediatric Subjects With Type 1 Gaucher Disease

Start date: July 31, 2019
Phase: Phase 4
Study type: Interventional

In August of 2014, the FDA approved ELELYSO for long-term enzyme replacement therapy (ERT) for pediatric subjects with a confirmed diagnosis of Type 1 Gaucher disease. The recommended dosage for treatment-naïve adult and pediatric subjects 4 years of age and older is 60 units per kg of body weight administered every other week as a 60 to 120 minute intravenous infusion. As a postmarketing commitment, the Sponsor agreed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of Elelyso (taliglucerase alfa) in pediatric subjects with Type 1 Gaucher Disease. in at least 5 subjects with body weight less than 15 kg; at least 5 subjects with body weight 15 to less than 20 kg; and at least 5 subjects with body weight of 20-25 kg with Type 1 Gaucher disease dosed at 60 units/kg every other week. When applicable, PD measurements for children enrolled in the PK study may be obtained through the taliglucerase alfa registry (PMR 1895-5) and will include organ volumes (spleen and liver), hematological values (hemoglobin and platelets) as well as growth (height and weight) data. Safety data, including any serious hypersensitivity reactions, such as anaphylaxis, as well as changes in antibody status (ie, detection and titers of binding and neutralizing antibodies, and detection of IgE antibodies), will also be collected through the taliglucerase alfa registry.

NCT ID: NCT03020563 Withdrawn - Clavicle Fracture Clinical Trials

Does Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?

Start date: August 23, 2017
Phase: Phase 4
Study type: Interventional

To determine whether liposomal bupivacaine wound infiltration decreases pain scores and narcotic use when compared to bupivacaine alone after open reduction internal fixation of midshaft clavicle fractures.

NCT ID: NCT03015519 Withdrawn - Clinical trials for Diabetes Mellitus, Type 2

A Study to Evaluate Pharmacokinetics, Safety and Efficacy of Albiglutide in Pediatric Subjects With Type 2 Diabetes Mellitus

Start date: August 14, 2017
Phase: Phase 3
Study type: Interventional

The incidence of Type 2 Diabetes Mellitus (T2DM) is increasing day by day but the treatment options are limited in children and adolescents. Albiglutide, approved for the treatment of T2DM in adult population, is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long half-life to permit once a week injection. The study will be conducted in 2 parts: Part A is a single dose pharmacokinetic (PK) study to confirm the dose and safety of albiglutide in pediatric subjects aged 10 to less than 18 years and Part B is a randomized double-blind placebo controlled study to evaluate the safety and efficacy (glycemic control) of albiglutide in the pediatric population. Treatment duration in Part B is 52 weeks (24 weeks double-blind placebo-controlled and 28 weeks open-label during which all subjects will receive albiglutide). Approximately 210 eligible male and female subjects will be included in the study.

NCT ID: NCT03014804 Withdrawn - Clinical trials for Recurrent Glioblastoma

Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen Vaccine and Nivolumab in Treating Patients With Recurrent Glioblastoma

Start date: December 1, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects of autologous dendritic cells pulsed with tumor lysate antigen vaccine and nivolumab and to see how well they work in treating patients with glioblastoma that has come back. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving dendritic cell-autologous lung tumor vaccine and nivolumab may work better in treating patients with glioblastoma.

NCT ID: NCT03014323 Withdrawn - Oxidative Stress Clinical Trials

Racial Differences in Vagal Control of Glucose Homeostasis, Chronic Study

RDVCGH
Start date: January 2017
Phase: Phase 1
Study type: Interventional

Investigators will test the hypothesis that chronic restoration of vagal nerve activity with a central acetylcholinesterase inhibitor improves insulin sensitivity and reduces adipose tissue oxidation in obese African American Women compared to white women.

NCT ID: NCT03014284 Withdrawn - Colon Cancer Clinical Trials

Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis

Start date: January 20, 2017
Phase:
Study type: Observational

This is a simple tissue collection study with no therapeutic intent. Colon tissues will be taken from standard of care procedures. Tissues will be tested for their functions, expression of immune co-signaling molecules and reactions to transduction with recombinant Listeria vectors to assess effects on expression of B7-H1 and cytokines.

NCT ID: NCT03014219 Withdrawn - Perianal Fistula Clinical Trials

Phase 1 Crohn's Pediatric Sub-study of MSC AFP

Start date: July 2017
Phase: Phase 1
Study type: Interventional

The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single dose of 20 million cells. 20 patients (age 12 to 17 years) with Crohns perianal fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient.