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NCT ID: NCT02576522 Completed - Brain Metastases Clinical Trials

Tumor Bed Hypofractionated IMRT After Surgery for Patients With Single,Large Brain Metastases From Solid Tumor

Start date: June 29, 2015
Phase: N/A
Study type: Interventional

Investigators designed a study of a multimodality approach: surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach for patients with single, large brain metastases from solid primary tumor

NCT ID: NCT02576509 Completed - Clinical trials for Hepatocellular Carcinoma

An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma

Start date: December 7, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

NCT ID: NCT02576041 Completed - Allergic Rhinitis Clinical Trials

Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria

F1
Start date: October 2015
Phase: Phase 4
Study type: Interventional

The aim of the study is to evaluate the effects of Bilastine on patients' attention and reactivity levels by measuring psychophysical performance at a F1-high speed simulator driving test.

NCT ID: NCT02573844 Completed - Clinical trials for Irritable Bowel Syndrome

Pain Relief In Irritable Bowel Syndrome

PRITON
Start date: January 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether Proklama is effective in significative reduction of pain, other symptoms IBS's related, and improves quality of life concerning IBS disease.

NCT ID: NCT02573649 Completed - Clinical trials for Syncope, Vasovagal, Neurally-Mediated

The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study

TIRECS
Start date: April 2015
Phase: N/A
Study type: Interventional

Multicentre, prospective, double blinded, randomized study designed as an intrapatient comparison to evaluate the effects of the Biotronik Closed-loop Stimulation algorithm on prevalence and timing of haemodynamic variations and clinical prodromes induced by head-up tilt test in patients underwent pacemaker implantation for refractory cardioinhibitory vasovagal syncope.

NCT ID: NCT02573467 Completed - Clinical trials for Sporadic Inclusion Body Myositis

An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203

Start date: November 2, 2015
Phase: Phase 3
Study type: Interventional

This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. The extension study was planned to consist of a Screening epoch (to assess patient eligibility), followed by a Treatment Period 1 epoch (double-blind and placebo-controlled), and a Treatment Period 2 epoch (open-label). A Post-treatment Follow-up (FUP) epoch was also planned for patients who discontinued prematurely. Patients who complete the core study and qualify for this extension study entered Treatment Period 1 and continued on the study drug to which they were randomized in the core study (either to one of the three bimagrumab doses (1 mg/kg, 3 mg/kg, and 10mg/kg) or placebo) during Treatment Period 1. Thus, Treatment Period 1 was double-blind and placebo-controlled. Participants were to continue in Treatment Period 1 until the dose with the best benefit-risk profile was determined from the core study data and selected (duration of Treatment Period 1 was estimated to be between 6 and 8 months). Once the dose with the best benefit-risk profile was selected, all participants (including those who were receiving placebo) were planned to enter Treatment Period 2 and switch to open-label treatment with bimagrumab at the selected dose. The core study has been completed but since the core study did not meet the primary end point (no bimagrumab dose was identified based on the core study efficacy results) the extension study was terminated as per protocol/sponsor's decision; therefore, no patients had entered Treatment Period 2. Instead, all patients were to return for the End of Treatment Period 1 (EOT1) visit at their next scheduled visit. As per protocol, all patients who discontinued study medication during Treatment Period 1 for any reason, including due to the study having been stopped as per protocol/sponsor's decision, were to have entered and complete the 6-month FUP after their EOT1 visit. Due to the nature of the design of the core and extension studies and termination of study medication in the extension study, the treatment duration for individual patients varied considerably. Consequently, the number of patients contributing data to the efficacy analyses at Week 104 and later timepoints was decreased.

NCT ID: NCT02573324 Completed - Glioblastoma Clinical Trials

A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

Intellance1
Start date: January 4, 2015
Phase: Phase 3
Study type: Interventional

This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification. In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.

NCT ID: NCT02573077 Completed - Cancer Clinical Trials

An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy

ASSERT
Start date: October 2015
Phase:
Study type: Observational

This observational, prospective, non-interventional study will include cancer patients who need a treatment for hyponatraemia secondary to SIADH. Patients will be prescribed treatment(s) according with the clinical practice regardless of the patient participation in the study. The purpose of this NIS is to collect additional scientific and clinical information that can help in describing the characteristics of cancer patients with hyponatraemia secondary to SIADH, the current management of hyponatremia, the therapies to keep under control serum [Na+] and the guidelines for the management of this population in Italy.

NCT ID: NCT02573012 Completed - Clinical trials for Rheumatoid Arthritis

Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Participants

Start date: March 29, 2016
Phase: Phase 4
Study type: Interventional

This Phase IIIb/IV, two-arm, randomized, double-blind, placebo-controlled, parallel-group, international, multicenter trial compares the change in disease activity (as assessed by Disease Activity Score in 28 joints [DAS28] erythrocyte sedimentation rate [ESR]) from randomization to Week 24 post-randomization, in participants with stable low disease activity [LDA] (DAS28 ESR score less than or equal to [<=] 3.2) who receive tocilizumab, and have been randomized to either continue or taper prednisone in a double-blinded fashion.

NCT ID: NCT02572687 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Study of Ramucirumab (LY3009806) Plus MEDI4736 in Participants With Advanced Gastrointestinal or Thoracic Malignancies

Start date: February 19, 2016
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety of ramucirumab plus MEDI4736 in participants with locally advanced and unresectable or metastatic gastrointestinal or thoracic malignancies including gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), or hepatocellular carcinoma (HCC).