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NCT ID: NCT03295435 Completed - Clinical trials for Oral Health of Older Men

Composition of Functional Tooth Units and Nutrient Intake in Older Men

CHAMP
Start date: August 5, 2014
Phase: N/A
Study type: Observational

Various definitions of poor dentition in older adults has been linked with inadequate intake of nutrients and poor diet quality. This study aims to look at the associations between poor dentition as defined by the composition of functional tooth units, and dietary intake of nutrients in community dwelling older men.

NCT ID: NCT03294681 Completed - Hearing Loss Clinical Trials

Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms

Start date: October 3, 2017
Phase:
Study type: Observational

The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.

NCT ID: NCT03294668 Completed - Clinical trials for Autism Spectrum Disorder

KONTAKT Australia a Social Skills Group Training for Adolescents on the Autism Spectrum

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

This study evaluates the KONTAKT social skills group training in Australian adolescents on the autism spectrum compared to an active control group which is a group cooking class

NCT ID: NCT03292237 Completed - Critical Illness Clinical Trials

Intensive Nutrition in Critically Ill Adults

INTENT
Start date: October 15, 2018
Phase: Phase 2
Study type: Interventional

Despite the widespread use of nutrition therapy, no large scale randomized controlled trials (RCTs) have demonstrated positive outcomes with delivery of nutrition therapy early in critical illness, with some showing no effect with delayed nutrition or even harm. There are several possible reasons for the lack of observed benefit from RCTs to date; interventions have been short in duration (usually 3-10 days after intensive care unit (ICU) admission), perhaps applied at the incorrect time in regards to the patients metabolism and recovery, do not consider the patients nutrition risk, and have not addressed what happens to nutrition intake post ICU in critically ill individuals. This may explain why RCTs to date have not observed any positive associations with the delivery of nutrition; our focus to date may have been on the wrong stage of illness. A future study is thus urgently needed, which addresses the deficiencies in current RCTs by optimizing nutrition delivery for the whole hospital stay and collecting meaningful clinical, process and outcome data, which will potentially inform a larger trial of a similar nature. This initial study aims to determine whether optimization of energy using a pre-tested supplemental parenteral nutrition (PN) strategy in the Intensive Care Unit (ICU) and an intensive nutrition intervention in the post ICU period will deliver more total energy than standard nutrition care during hospital admission in a group of critically ill patients with at least one organ system failure.

NCT ID: NCT03290781 Completed - Ulcerative Colitis Clinical Trials

An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

FIGARO UC 303
Start date: April 4, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

NCT ID: NCT03290560 Completed - Clinical trials for Acute Ischemic Stroke

Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke

ReMEDy1
Start date: January 19, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase II study to assess the safety and tolerability of DM199 in acute ischemic stroke patients. The study will be randomized, placebo controlled at multiple centers.

NCT ID: NCT03287427 Completed - Colorectal Cancer Clinical Trials

MYPHISMO: MYB and PD-1 Immunotherapies Against Multiple Oncologies Trial

MYPHISMO
Start date: August 22, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to look at the effects, good or bad, of TetMYB Vaccine in combination with BGB-A317 in patients with advanced or metastatic solid cancers (including colorectal or adenoid cystic cancer). The immune system is the body's defence against cancer, bacteria and viruses. TetMYB Vaccine is a vaccine that helps your immune system to recognise the cancer cells. BGB-A317 is an antibody (a type of protein made in the body in response to a foreign substance) that helps to stop or reverse the growth of tumour cells. Up to 32 participants may take part in this study, which is divided into 2 stages: dose escalation (different doses will be tested in small groups of patients) and dose expansion (one or more doses may be tested in a larger group of patients). Which stage you participate in will depend on which is open at the time. Your study doctor will discuss this with you. During dose escalation, study patients will receive increasing doses of the TetMYB Vaccine, starting at a low dose. During dose expansion, study patients will receive the dose determined as safe in dose escalation. The study design is as follows: In the dose finding stage, the first patient of each dose level will receive 6 consecutive weekly doses of intradermal TetMYB monotherapy for safety evaluation. If there are no reported DLTs, the next 2 patients of the same dose level will also receive 6 consecutive weekly intradermal doses of TetMYB, however with 3 weekly doses of BGB-A317 commencing with the fourth TetMYB dose. The dosage of TetMYB are as follows: - Dose level 1: 100 ug in 100 uL of sterile dH2O containing 5% DMSO - Dose level 2: 500 ug in 100 uL of sterile dH2O containing 5% DMSO - Dose level 3: 1000 ug in 100 uL of sterile dH2O containing 5% DMSO. In the dose expansion stage, the dosage will be the maximum tolerated dose (MTD) identified in the dose-finding stage and in combination with BGB-A317. TetMYB Vaccine is being developed and manufactured by the Peter MacCallum Cancer Centre according to Good Manufacturing Practice (GMP) and in accordance with guidelines provided by the Food and Drug Administration (FDA) in the USA and Therapeutic Goods Administration (TGA) in Australia. TetMYB Vaccine is an experimental treatment and is currently not approved for use in any country. This means that it is not an approved treatment for cancer in Australia. This will be the first time that the TetMYB vaccine is given to humans. BGB-A317 is being developed by BeiGene, a biopharmaceutical company. BGB-A317 is an experimental treatment. This means that it is not an approved treatment for solid cancers in Australia.

NCT ID: NCT03284723 Completed - Breast Neoplasms Clinical Trials

PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors

Start date: November 1, 2017
Phase: Phase 1
Study type: Interventional

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer.

NCT ID: NCT03284424 Completed - Clinical trials for Squamous Cell Carcinoma

Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)

Start date: October 26, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in adult participants with recurrent or metastatic(R/M) cutaneous Squamous Cell Carcinoma (cSCC) or locally advanced (LA) unresectable cSCC that is not amenable to surgery and/or radiation and/or systemic therapies.

NCT ID: NCT03283085 Completed - Ulcerative Colitis Clinical Trials

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

Start date: February 27, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD)