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NCT ID: NCT03829488 Recruiting - Clinical trials for Delayed Graft Function

Better Evidence for Selecting Transplant Fluids

BEST-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: NCT03780543 Enrolling by invitation - Chronic Hepatitis B Clinical Trials

A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients

Start date: December 20, 2018
Phase: Phase 2
Study type: Interventional

Open-label, extension study to evaluate the safety and efficacy of combination therapy and it's effect on sustained viral response biomarkers.

NCT ID: NCT03772249 Recruiting - Clinical trials for Hepatitis B, Chronic

Study of Safety and Tolerability of DCR HBVS

Start date: December 28, 2018
Phase: Phase 1
Study type: Interventional

DCR-HBVS will be evaluated for safety and efficacy in normal healthy volunteers and chronic hepatitis B patients.

NCT ID: NCT03763812 Not yet recruiting - Clinical trials for Abdominal Aortic Aneurysm

Post Implant Syndrome After EVAR and EVAS (INSPIRE Study)

Start date: December 2018
Phase: N/A
Study type: Interventional

Retrospective data have shown that active sac management, as applied in EVAS, reduces the incidence of the post-implant syndrome. All-cause and cardiac mortality at one-year seems to be lower after EVAS when compared to EVAR. Ongoing, low grade, inflammation could differ between techniques and induce cardiac damage. This study is designed to establish whether EVAS results in a reduced post-operative inflammatory response during the first year after surgery, compared to EVAR as assessed by trends in circulating inflammatory cytokine concentration. Study design: International prospective, comparative, explorative study. Study population: Patients scheduled to undergo infra-renal EVAR with a polyester endograft or EVAS for an infrarenal aortic aneurysm. This is an explorative study and therefore only patients who would normally receive a suitable device as part of standard treatment at the participating institutes will be recruited. Blood samples will be taken at specified time points before and after surgery. Main study parameters/endpoints: The difference in early post-operative and long term inflammatory response between EVAS and EVAR, measured by the incidence of the post-implant syndrome. To investigate the incidence of the post-implant syndrome, the rise in CRP, WBC and circulating cytokines, at specified time points up to 12 months after surgery and the change in aortic thrombus volume and its relationship with the inflammatory response, measured by cytokines' concentrations.

NCT ID: NCT03762681 Recruiting - Clinical trials for Hepatitis B Virus Infection

A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection

Start date: December 15, 2018
Phase: Phase 1
Study type: Interventional

This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses in healthy participants and participants diagnosed with chronic hepatitis B (CHB).

NCT ID: NCT03757338 Completed - Healthy Volunteers Clinical Trials

Bioequivalence Study of a Test Capsule Formulation of Fingolimod With the Reference Capsule Formulation of Fingolimod

Start date: October 23, 2015
Phase: Phase 1
Study type: Interventional

The study evaluates the bioequivalence of the Test formulation, 0.5 mg Fingolimod HCl capsule (Asofarma S.A.I. y C. on behalf of Tolmar, Batch No. 22264), relative to that of the Reference formulation, 0.5 mg Gilenya® (fingolimod) capsule (Novartis Pharmaceuticals, Batch No. S0099), following oral administration of a single oral dose of 3 x 0.5 mg in healthy, adult, male and female subjects under fasting conditions.

NCT ID: NCT03752580 Completed - Clinical trials for Obstructive Sleep Apnea

An Investigation to Test a Prototype Nasal Mask in the Home Setting

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

This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. The clinical investigation will be conducted in New Zealand and participants will interact with the user instructions in a one hour daytime visit. A minimum of 15 participants will participate in this trial.