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NCT ID: NCT03798574 Completed - Clinical trials for Meningococcal Infections

The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults

AMEND
Start date: March 1, 2016
Phase:
Study type: Observational

Survivors of invasive meningococcal disease (IMD) experience a range of mild to severe sequelae that impact upon their quality of life. The majority of studies to date have focused on the impact of IMD on childhood and very little is known about the impact of the disease on adolescents and young people. The aim of this study is to assess the physical, neurocognitive, economic and societal impact of IMD on adolescents and young adult Australian survivors. Hypothesis: 1. Adolescents and young adult survivors who are 2 to 10 years post IMD have significantly poorer outcomes including intellectual functioning and quality of life when compared to healthy controls. 2. IMD imposes a significant financial burden upon individuals, families and society. 3. Serogroup B disease is associated with an increased risk of sequelae when compared to non-B serogroup IMD. Study design: This a multi-centre, case-control mixed-methods study. Survivors of IMD (retrospective and prospective cases) and non-IMD healthy controls will be invited to participate in the study. Retrospective IMD cases admitted in the previous 10 years will be identified through each of the participating hospitals (paediatric and adult hospitals). During the course of the study prospective recruitment of IMD cases will also occur at participating hospitals. Meningococcal foundations/groups will also be approached and asked to advertise and conduct a mail out to their members to inform them about the study. Healthy controls will be prospectively recruited by "snowballing technique" whereby enrolled IMD cases will be asked to distribute a study information sheet to their healthy friends/acquaintances who are approximately the same age. Control participants may also be identified from databases at each participating site or through community advertising. Enrolled cases will undergo a neurocognitive, psychological and physical examination 2 - 10 years post IMD admission. A subset of IMD cases will be invited to participate in a semi-structured interview. Controls will also undergo neurocognitive, psychological and physical examination.

NCT ID: NCT03797664 Completed - Healthy Clinical Trials

A Study of the Safety and Tolerability of CDX-6114 in Healthy Volunteers

Start date: December 14, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of an oral solution of CDX-6114 when administered as a single dose in healthy volunteers

NCT ID: NCT03796676 Completed - Atopic Dermatitis Clinical Trials

JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis

JADE TEEN
Start date: February 18, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to <18 years of age with moderate to severe AD.

NCT ID: NCT03793244 Completed - Critical Illness Clinical Trials

TARGET-Metabolic Effects

TARGET-ME
Start date: July 1, 2017
Phase:
Study type: Observational

The estimation of calorie needs during routine practice in critically ill patients is highly variable and the thermogenic effect of continuous delivery of enteral nutrition (EN) on overall calorie utilisation in critically ill adults is unknown. The TARGET-ME study is a substudy of the TARGET trial (NCT02306746). The TARGET trial provides the perfect opportunity to measure calorie utilisation via indirect calorimetry (IC) and ventilator-derived carbon dioxide production (VCO2) to compare measured calorie utilisation to estimation methods, determine the potential thermic effect of EN solutions with different energy concentrations and investigate any associations with outcome.

NCT ID: NCT03792841 Completed - Prostate Cancer Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC

Start date: February 5, 2019
Phase: Phase 1
Study type: Interventional

A phase 1 study evaluating the safety, tolerability, pharmacokinetics, and efficacy of prostate specific membrane antigen half-life extended bispecific T-cell engager acapatamab in subjects with metastatic castration-resistant prostate cancer, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

NCT ID: NCT03792555 Completed - Acromegaly Clinical Trials

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)

Start date: December 18, 2018
Phase: Phase 2
Study type: Interventional

A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.

NCT ID: NCT03792308 Completed - Healthy Volunteers Clinical Trials

A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy Volunteers

Start date: December 18, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of SPR206 when administered to healthy adult volunteers.

NCT ID: NCT03790709 Completed - Alzheimer Disease Clinical Trials

ANAVEX2-73 for Treatment of Early Alzheimer's Disease

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

Phase 2b/3 48-week study to evaluate the effects of ANAVEX2-73 on cognition and function after 48 weeks of daily treatment. Additional outcome measures include refined measures of sleep, behavioral and psychological symptoms typically observed in AD, changes in daily functioning of participants and changes in caregiver burden, as well as changes in quality of life measures of both, patients and caregivers during treatment with ANAVEX2-73.

NCT ID: NCT03789656 Completed - Acromegaly Clinical Trials

An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

Start date: January 15, 2019
Phase: Phase 2
Study type: Interventional

An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.

NCT ID: NCT03785925 Completed - Neoplasm Metastasis Clinical Trials

A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer

PIVOT-10
Start date: April 29, 2019
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.