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NCT ID: NCT03903731 Recruiting - Clinical trials for Journey II BCS Total Knee System

Safety and Performance of Journey II BCS Total Knee System Patient Reported Outcome Measures

Start date: July 19, 2018
Study type: Observational

Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study. Patient Reported Outcome Measures.

NCT ID: NCT03889210 Not yet recruiting - PreDiabetes Clinical Trials

β-hydroxybutyrate, Glucose Metabolism and Prediabetes

Start date: March 31, 2019
Phase: N/A
Study type: Interventional

The study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink.

NCT ID: NCT03885882 Not yet recruiting - Healthy Subjects Clinical Trials

A Pharmacokinetic (PK) Study of Three Types of E0302 Sustained Release (SR) Tablets Compared With E0302 Immediate Release (IR) Tablet Under Fed Conditions in Healthy Participants

Start date: April 17, 2019
Phase: Phase 1
Study type: Interventional

To assess the PK and safety after administration of three types of E0302 SR tablets (SR1, SR2, SR3) and E0302 IR tablet.

NCT ID: NCT03859895 Recruiting - Paget Disease Clinical Trials

Zoledronate In the Prevention of Paget's Disease: Long Term Extension

Start date: April 2019
Study type: Observational

Paget's disease of the bone (PDB) is a metabolic bone disorder which in some individuals can cause pain, bone deformity, arthritis and deafness, although in many patients it does not cause symptoms. Paget's disease has a strong genetic component and SQSTM1 is the most important susceptibility gene. People who inherit mutations in SQSTM1 have a high risk of developing PDB later in life. This study is an extension of the ZiPP (Zoledronate in the Prevention of Paget's) study which was is randomised trial currently in progress to determine if the bisphosphonate zoledronic acid (ZA) can prevent or delay the development of PDB-like bone lesions compared with a dummy treatment (placebo) in people who inherit SQSMT1 gene mutations. Although the ZiPP study will provide information on whether early ZA treatment can favourably influence bone lesion development the significance of this to the patient in terms of symptoms is unclear as yet. The aim of the extension study is to keep these individuals under surveillance for any symptoms or signs of PDB over a further 5 year period and to evaluate if there has been any progression of PDB-like lesions by bone scan at the end of this period.

NCT ID: NCT03847909 Recruiting - Kidney Diseases Clinical Trials

A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2

Start date: March 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of DCR-PHXC in Children and Adults with Primary Hyperoxaluria Type 1 (PH1) and Primary Hyperoxaluria Type 2 (PH2)

NCT ID: NCT03829488 Recruiting - Clinical trials for Kidney Transplant; Complications

Better Evidence for Selecting Transplant Fluids

Start date: January 26, 2018
Phase: Phase 3
Study type: Interventional

End-stage kidney disease (ESKD) is a significant, expensive health problem. Kidney transplantation improves survival, quality of life, and is much cheaper than dialysis treatment for ESKD. However sometimes kidney transplants from a deceased donor function poorly after surgery, and a period of continued dialysis is needed, a condition known as delayed graft function (DGF). In addition to complicating recovery, DGF can adversely affect long-term kidney function and the health of the recipient. Intravenous fluids given during and after transplantation (usually 0.9% sodium chloride or saline) are critical to preserve kidney transplant function, but there is evidence that 0.9% saline may not be the safest fluid to use due to its high chloride content. BEST Fluids is a randomised controlled trial that aims to find out whether using a balanced low-chloride solution - Plasma-Lyte 148® - as an alternative to normal saline in deceased donor kidney transplantation, will improve kidney transplant function, reduce the impact of DGF, and improve long-term outcomes for patients.

NCT ID: NCT03827018 Recruiting - Clinical trials for Giant Cell Arteritis

KPL-301 for Subjects With Giant Cell Arteritis

Start date: December 21, 2018
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of mavrilimumab (KPL-301) versus placebo, co-administered with a 26-week corticosteroid taper, for maintaining sustained remission for 26 weeks in subjects with new onset or relapsing/refractory giant cell arteritis (GCA).

NCT ID: NCT03826537 Completed - Tutin Poisoning Clinical Trials

A Study of How Tutin and Hyenanchin, Two Toxins Found in Honey, Are Absorbed and Processed by the Body

Start date: January 2012
Phase: N/A
Study type: Interventional

Honey available in New Zeland can contain the toxins tutin and hyenanchin. Tutin is produced by several plants native to New Zealand. Bees collect honeydew contaminated with tutin and hyenanchin for honey production. Honey contaminated with high levels of tutin has caused cases of poisoning in New Zealand since the 1800s, with the most recent outbreak in 2008. The study aims to find out how tutin and hyenanchin are absorbed and processed by the body. This information will help the FSANZ give guidance on acceptable levels of tutin and hyenanchin in honey. About 6 healthy men will each take a single dose of honey containing known concentrations of tutin and hyenanchin. This dose level is similar to what someone who eats a lot of honey would have, if the honey contained the maximum level of tutin allowed under the Food Standards Code. Blood tests to measure tutin and hyenanchin levels will be taken at certain times after dosing, and any side effects will be recorded.

NCT ID: NCT03802799 Recruiting - Fragile X Syndrome Clinical Trials

Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS

Start date: November 9, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

ZYN002 is a pharmaceutically manufactured Cannabidiol (CBD) that is developed as a clear gel that can be applied to the skin (called transdermal delivery). The gel will be applied to clean, dry, intact skin of the shoulders and/or upper arms. Only participants from the ZYN2-CL-016 study who meet the inclusion criteria and none of the exclusion criteria for study ZYN2-CL-017 are eligible. Parents/caregivers will apply the study gel twice daily for the 52-week treatment period.

NCT ID: NCT03786783 Recruiting - Clinical trials for Ganglioneuroblastoma

Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant

Start date: January 14, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and how well dinutuximab and sargramostim work with combination chemotherapy in patients with high-risk neuroblastoma undergoing stem cell transplant. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Sargramostim helps the body produce normal infection-fighting white blood cells. Giving chemotherapy before a stem cell transplant, with drugs such as cisplatin, etoposide, vincristine, doxorubicin, cyclophosphamide, thiotepa, melphalan, etoposide, carboplatin, topotecan, and isotretinoin, helps kill any cancer cells that are in the body and helps make room in a patient's bone marrow for new blood-forming cells (stem cells). Giving dinutuximab and sargramostim with combination chemotherapy may work better in treating patients with high-risk neuroblastoma undergoing stem cell transplant.