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NCT ID: NCT03292341 Completed - Larynx Cancer Clinical Trials

Evaluation of a Web-based Decision Aid Tool for Larynx Cancer (T3/T4) Patients.

LaDecA
Start date: September 2015
Phase: N/A
Study type: Interventional

Patients diagnosed with T3/T4 laryngeal cancer in general have several treatment options available, including total laryngectomy and/or (chemo-) radition. In order to help these patients in the decision making process, MAASTRO CLINIC designed and developed a web-based decision aid tool (Treatmentchoice). The aim of this study is twofold: user-testing Treatmentchoice using a systematically development process and establish the impact of Treatmentchoice on the decision making process. The study covers 4 chronological activities: 1. assess decisional needs of patients and clinicians, 2. testing patients' and clinicians comprehensibility, acceptability and usability on the alpha-version of the tool, 3. establish the impact of Treatmentchoice on knowledge, decisional conflict and the shared decision making process, as well as the extent clinicians involve patients in decision making and 4. development of an implementation and dissemination plan for shared decision making which is based on the evaluation of barriers and facilitators for the use of patients decision aid tools in clinical practice. A mixed method will be used. It comprises structured interviews combined with think aloud and questionnaires with stakeholders involved in the whole process (patients, medical doctors, nurses, general practitioners, patient organizations, and insurance companies).

NCT ID: NCT03291288 Completed - Clinical trials for Drug Interaction Potential

Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)

Start date: February 26, 2018
Phase: Phase 1
Study type: Interventional

This study has two parts. Part 1 will evaluate how pexidartinib affects the way the body processes CYP3A4 and CYP2C9 substrates using midazolam and tolbutamide, respectively, as probe agents. Part 2 will test the efficacy and safety of pexidartinib treatment in various tumor types. In Part 2, the same participants will continue to receive pexidartinib twice daily. Participants will be allowed to continue using pexidartinib as long as the participant derives benefit.

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: NCT03289897 Completed - Metabolic Syndrome Clinical Trials

Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan

RADIcAL1
Start date: September 5, 2017
Phase: N/A
Study type: Interventional

A multi-centre randomised controlled trial to determine the implementation and health care cost of LiverMultiScan vs. routine methodical assessment (standard care) of Non-alcoholic fatty liver disease (NAFLD) across several European countries.

NCT ID: NCT03289715 Completed - Clinical trials for Neuromuscular Diseases

Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation

Start date: January 12, 2018
Phase: N/A
Study type: Interventional

Monocenter study to determine and evaluate the optimal amount of humidification doses delivered by the On-Demand humidification system in neuromuscular patients requiring home mechanical ventilation. The patient's perception will be monitored with subjective as well as with objective measurements of the optimum comfortable on-demand humidification doses.

NCT ID: NCT03289273 Completed - Liver Neoplasms Clinical Trials

Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)

Start date: September 13, 2017
Phase:
Study type: Observational

Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)

NCT ID: NCT03287960 Completed - Clinical trials for Leptin Receptor Deficiency Obesity

Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity

Start date: January 30, 2018
Phase: Phase 3
Study type: Interventional

To demonstrate statistically significant and clinically meaningful effects of setmelanotide on percent body weight change in participants with LEPR deficiency obesity due to rare bi-allelic or loss-of function mutations at the end of 1 year of treatment.

NCT ID: NCT03286816 Completed - Clinical trials for Type 1 Diabetes Mellitus With Hypoglycemia

The Effect of Intravenous Lactate on Brain Lactate Concentrations During Hypoglycemia

Start date: November 2016
Phase: N/A
Study type: Interventional

Patients with type 1 diabetes (T1DM) who are unable to perceive symptoms of hypoglycemia, referred to as impaired awareness of hypoglycemia (IAH), are at very high risk of severe hypoglycemia. IAH affects approximately 25% of patients with T1DM. Brain lactate may be involved in the development of IAH. A recent study indicated increased brain lactate utilization during hypoglycemia in T1DM patients with IAH, which did not occur in patients with normal awareness of hypoglycemia (NAH). Conversely, administration of lactate to patients with NAH has been shown to attenuate counterregulatory hormone responses to and symptomatic awareness of hypoglycemia, thus causing a situation that resembles IAH. It has, however, not been demonstrated whether the excess of lactate is actually taken up or metabolized by the brain, and if so whether this occurs under euglycemic or hypoglycemic conditions or both. This project consists of two related studies. The objective of part 1 is to investigate the effect of elevated plasma lactate levels that are sufficient to impair awareness of hypoglycemia on brain lactate concentrations during euglycemia and hypoglycemia in T1DM patients with NAH. The objective of part 2 is to compare the effect of exogenous lactate on brain lactate concentrations between T1DM patients with NAH and T1DM patients with IAH. Furthermore, this study aims to determine the effect of acute hypoglycemia on the inflammatory function and composition of peripheral blood mononuclear cells.

NCT ID: NCT03286400 Completed - Thoracic Diseases Clinical Trials

Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL

SURPASS
Start date: October 18, 2017
Phase:
Study type: Observational [Patient Registry]

Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice.

NCT ID: NCT03285763 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

TAIL
Start date: October 25, 2017
Phase: Phase 4
Study type: Interventional

This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 [anti-PD-1] therapy, after anti-PD-1 as monotherapy, or after tyrosine kinase inhibitor [TKI] therapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period.