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NCT ID: NCT04896515 Completed - Critically Ill Clinical Trials

INTENT-Muscle (A Sub-study of INTENT)

Start date: June 21, 2021
Phase:
Study type: Observational

The currently recruiting randomised controlled trial "Intensive Nutrition Therapy Compared to Usual Care in Critically Ill Adults" (INTENT, NCT03292237) is the first multi-centre trial to compare an intensive, individualised nutrition intervention to standard care for the duration of hospital admission in critically ill patients. INTENT-Muscle, is an observational longitudinal study nested within INTENT. The aim of INTENT-Muscle is to compare longitudinal changes in muscle health (assessed by bioimpedance and muscle ultrasound) in critically ill patients randomised to each arm of INTENT.

NCT ID: NCT04893512 Completed - Clinical trials for SARS-CoV-2 (COVID-19)

First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects

Start date: June 30, 2021
Phase: Phase 1
Study type: Interventional

To evaluate the safety of 2 dose vaccination schedule of orally administered CoV2-OGEN1 In healthy subjects

NCT ID: NCT04890249 Completed - Cataract Clinical Trials

Clinical Investigation of Two Tecnis Investigational Lenses

Start date: June 23, 2021
Phase: N/A
Study type: Interventional

This study is a 6-month, prospective, multicenter, randomized (1:1:1), subject-masked and evaluator-masked, bilateral clinical investigation of the TECNIS IOL Models C1V000 and C2V000 versus the TECNIS Eyhance™ Model ICB00 IOL. The study will be conducted at up to 15 sites in EU, AU, NZ and/or AP and will enroll up to 225 subjects to achieve approximately 67 bilaterally implanted subjects in each lens group. Allowing for 10% lost-to-follow-up, this will achieve approximately 60 evaluable subjects in each lens group at 1, 3, and 6 months. The eye implanted first will be considered the primary (monocular) study eye.

NCT ID: NCT04889690 Completed - Healthy Clinical Trials

Study of Multiple Doses of Danicopan in Healthy Participants

Start date: May 21, 2016
Phase: Phase 1
Study type: Interventional

This was a multiple ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (75 milligrams [mg], 200 mg, 500 mg, 800 mg) and dose-matched placebo were administered under fasted conditions.

NCT ID: NCT04889677 Completed - Healthy Clinical Trials

Study of a Single Dose of Danicopan in Healthy Participants

Start date: February 4, 2016
Phase: Phase 1
Study type: Interventional

This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (200 milligrams [mg], 600 mg, 1200 mg, 2400 mg) and dose-matched placebo were administered under fasted and fed conditions.

NCT ID: NCT04889391 Completed - Healthy Clinical Trials

Study of Radiolabeled Danicopan in Healthy Male Participants

Start date: September 14, 2017
Phase: Phase 1
Study type: Interventional

This was an open-label study to evaluate the absorption, distribution, metabolism, and excretion of radioactivity in healthy male participants following a single 150-milligram (mg) oral dose of carbon-14 ([14C])-ACH-014447 ([14C])-danicopan) containing approximately 100 microcuries (µCi) of [14C].

NCT ID: NCT04885829 Completed - Clinical trials for Rheumatoid Arthritis

Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers

Start date: May 31, 2021
Phase: Phase 1
Study type: Interventional

A single dose, two period trial where participants will be given either of 3 Tocilizumab product on Day 1 during period 1 and either one of the remaining 2 Tocilizumab products on Day 1 period 2. There will be at least 6 weeks (42 days) of wash out between subsequent two period dosing. The maximum flexibility allowed between subsequent periods will be up to 9 weeks (63 days). Names of the 3 tocilizumab products are DRL_TC, RP and RMP. So if a participant receives DRL_TC on Day 1 Period 1 then he/she will either receive RP/RMP on Day 1 Period 2.

NCT ID: NCT04881123 Completed - Clinical trials for Diabetic Kidney Disease

SER150 vs Placebo in Diabetic Kidney Disease

Start date: August 18, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study is to assess the efficacy and safety of SER150 administered for 24 weeks as a 15 mg twice a day BID dose (except on Day 168 15 mg QD) in participants with type 2 diabetes (T2D) and albuminuria in treatment with either an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor antagonist (ARB).

NCT ID: NCT04869163 Completed - Well-being Clinical Trials

Sustained Meat and Alternative Intake (PRotEin DIet SatisfacTION Trial 4) (PREDITION)

Start date: May 17, 2021
Phase: N/A
Study type: Interventional

Introduction The trend of flexitarian eating patterns is on the rise, with young adults amongst the biggest adopters claiming health and environmental reasons to reduce red meat intake. Nutrient dense meat and animal products are often the lynchpin of these diets, even when consumed only occasionally and in moderate amounts. Red meat provides forms and concentrations of essential proteins, lipids, and micronutrients that are scarce in exclusively vegetarian regimens. The aim of this investigation is to consider the effects of moderate consumption of lean red meat as part of an otherwise vegetarian balanced diet and its impact on biomarkers of sustained health and wellbeing. Methods and analyses A cohort of healthy, young (20-34 years) male and female participants will take part in two-arm parallel, randomised-controlled trial for a duration of 12 weeks, with a 3-month post follow-up. The trial will commence with a two-week assessment period followed by allocation to the intervention arms. The intervention will include the consumption of red meat or meat-alternatives three times per week for 10 weeks. Blood samples of the participants will be measured for changes in erythrocyte fatty acid distribution, circulating amino acids, neurotransmitters, markers of mineral status and inflammatory markers. Questionnaires to assess wellbeing and mental health will be undertaken every two weeks. Body composition, physical function test, blood measurements will be assessed at allocation (t0), week five into the intervention (t5) and post intervention (t10). Discussion To our knowledge this is the first randomised controlled trial (RCT) investigating the overarching health consequences of consuming NZ pasture fed red meat or no meat, as part of a healthy diet. Ethics and dissemination The trial was approved by the New Zealand Ministry of Health's Health and Disability Ethics Committees (20/STH/157).

NCT ID: NCT04865393 Completed - Renal Impairment Clinical Trials

Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function

Start date: June 8, 2021
Phase: Phase 1
Study type: Interventional

Evaluation of the pharmacokinetics (PK) of SPR206 in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.