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NCT ID: NCT02905266 Completed - Melanoma Clinical Trials

A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma

Start date: October 27, 2016
Phase: Phase 3
Study type: Interventional

This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.

NCT ID: NCT02903771 Completed - Ovarian Neoplasms Clinical Trials

Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.

Start date: November 2016
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to determine the safety and feasibility of weekly intra-peritoneal administration of Cantrixil to women with persistent or recurrent ovarian cancer, Fallopian tube cancer or primary peritoneal cancer. The study also aims to determine the maximum tolerated dose of Cantrixil in these patients when administered as a monotherapy or a combination therapy.

NCT ID: NCT02903615 Completed - Diabetes Mellitus Clinical Trials

Optimising Health in Type 1 Diabetes

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

Type 1 diabetes is an autoimmune condition where circulating immune cells destroy the beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency, whereby blood glucose levels rise and diabetes develops. When there is severe insulin deficiency, life-threatening ketoacidosis can develop. Treatment is lifelong insulin replacement therapy; dietary intervention is a also cornerstone of glucose management. The Optimise Diet is a multi-pronged diet based on "best health" principles: to minimise blood glucose rises after eating, reduce the immune cells involved in destruction of the insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. In this study, its effects will be compared to the Standard Diabetes Diet that is currently recommended in Australia and internationally.

NCT ID: NCT02899611 Completed - Epilepsy Clinical Trials

A Dose Ranging Pilot Study for Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Temporal Seizures

Start date: August 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with medically refractory epilepsy will be treated by intracerebroventricular (ICV) delivery of valproate using an implantable drug pump system. The dose of valproate will be escalated weekly during a blinded-evaluation period through Day 64 to determine the maximum tolerated dose (MTD). After Day 64, patients can continue for 52 weeks in the open-label evaluation period (non-blinded). .

NCT ID: NCT02899299 Completed - Mesothelioma Clinical Trials

Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients

CheckMate743
Start date: November 29, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

NCT ID: NCT02898727 Completed - Breast Neoplasms Clinical Trials

A Study of Local Therapy for the Treatment of Brain Metastases From HER2 Positive Breast Cancer

Local HER-O
Start date: November 20, 2017
Phase: N/A
Study type: Interventional

This study aims to show that brain metastases from Human Epidermal Growth Factor Receptor Type 2 (HER2) positive breast cancers are able to be controlled by local therapies, Stereotactic Radiosurgery (SRS) and/or Neurosurgery (NS), without the need for Whole Brain Radiotherapy (WBRT).

NCT ID: NCT02898454 Completed - Clinical trials for Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)

Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

SINUS-52
Start date: November 28, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab 300 mg every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion (NC)/obstruction severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyps (NP). In addition for Japanese participants, reduction in computed tomography (CT) scan opacification of the sinuses was a co-primary objective. Secondary Objectives: - To evaluate the efficacy of dupilumab in improving total symptoms score. - To evaluate the efficacy of dupilumab in improving sense of smell. - To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japanese participants). - To evaluate ability of dupilumab in reducing proportion of participants who required treatment with systemic corticosteroids (SCS) or surgery for NP. - To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life. - To evaluate the efficacy of dupilumab 300 mg q2w up to Week 52. - To evaluate the efficacy of dupilumab 300 mg q2w up to Week 24 followed by 300 mg every 4 weeks (q4w) up to Week 52. - To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and comorbid asthma including non-steroid anti-inflammatory drug exacerbated respiratory disease. - To evaluate the safety of dupilumab in participants with bilateral NP. - To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment emergent anti-drug antibodies.

NCT ID: NCT02894736 Completed - Major Depression Clinical Trials

Home-Administered Trial of Direct Current Stimulation

HAT-DCS
Start date: March 2016
Phase: N/A
Study type: Interventional

Transcranial Direct Current Stimulation (tDCS) is a novel non-invasive brain stimulation treatment that is effective with no significant side effects. It can potentially be self-administered by patients in their own homes with remote monitoring, substantially reducing treatment costs and increasing accessibility, including to remote areas. This study will evaluate the feasibility and efficacy of home-administered tDCS treatment for depression.

NCT ID: NCT02892149 Completed - Anemia Clinical Trials

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Start date: August 2016
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-CKD)

NCT ID: NCT02892058 Completed - Osteoarthritis Clinical Trials

Self-assessment of Flare in Osteoarthritis of Lower Limbs

FLARE-OA
Start date: April 2015
Phase:
Study type: Observational

The need for a tool to measure flare in lower limb osteoarthritis (OA of the hip and knee) is justified by the opportunities for development of clinical trials targeting hip and knee OA long-term treatment (slow acting drug, disease modifying drug) and short-term treatment of symptoms. Such treatments are currently under development and will likely bring important changes in the treatment of patients. The development of a Flare-OA tool would be essential to capture the occurrence of flare, and to implement and adapt treatment strategies. This project was elaborated with the aims to: 1. define the construct through development of a conceptual framework 2. use the conceptual framework to inform the development of a patient-reported outcome measure, Flare-OA tool, for people with OA 3. evaluate the psychometric properties of the new measure using the OMERACT (Outcome Measures in Rheumatology) filter 2.0 and Rasch measurement methods.