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NCT ID: NCT03529110 Active, not recruiting - Breast Cancer Clinical Trials

DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

Start date: August 9, 2018
Phase: Phase 3
Study type: Interventional

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

NCT ID: NCT03529045 Active, not recruiting - Epilepsy Clinical Trials

Registry of Subjects With Drug Resistant Epilepsy and Treated With the VNS Therapy System.

CORE-VNS
Start date: February 5, 2018
Phase:
Study type: Observational [Patient Registry]

Multicenter global post-market registry of subjects diagnosed with drug resistant epilepsy and treated with the VNS Therapy System.

NCT ID: NCT03528473 Active, not recruiting - Quality of Life Clinical Trials

Adapted Physical Activity (APA) in a Breast Cancer Population.

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of a 6-months program of Adapted Physical Activity (APA) on lifestyle, physical activity levels, insulin resistance and adipokines, oxidative stress, microcirculatory haemodynamics and serum levels of specific circulating miRNA in post-menopausal, physically inactive breast cancer patients in oncologic follow-up with or without hormone therapy that had completed adjuvant treatment (radiotherapy and/or chemotherapy) . Furthermore, the study will determine the impact of APA on functional capabilities, on self-reported physical activity, quality of life and psychic health.

NCT ID: NCT03525678 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody

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

Multiple myeloma (MM) is an incurable malignancy and accounts for 1 percentage (%) of all cancers and for 10% of all hematologic malignancies. Participants with relapsed/refractory multiple myeloma (RRMM) will be included in this study, to evaluate the efficacy and safety of belantamab mafodotin (GSK2857916) monotherapy. Participants will be treated with belantamab mafodotin monotherapy until disease progression (PD) or unacceptable toxicity and will be followed for Progression Free Survival and Overall survival. The participants will be randomized to receive either frozen belantamab mafodotin at the dose of 2.5 milligram per kilogram (mg/kg) or 3.4 mg/kg administered Intravenously (IV). There will be an independent cohort of participants who will receive a lyophilized configuration of belantamab mafodotin. For participants who discontinued from the study other than Progressive disease (PD), disease evaluation will continue to be performed at 3-week intervals until confirmed PD, death, start of a new anticancer treatment, withdrawal of consent, or end of the study whichever occurs first.

NCT ID: NCT03525587 Active, not recruiting - Clinical trials for Growth Hormone Deficiency

Development and Validation of a Self-assessment System Based on a Mobile App to Manage Adult Growth Hormone Deficiency

GrASS
Start date: January 17, 2018
Phase: N/A
Study type: Interventional

Adult Growth Hormone Deficiency (AGHD) is a recognized clinical entity but several barriers concerning patient-clinician communication, inadequate patients' awareness of the disease, low perceived benefit of replacement therapy and poor compliance still remains. The overall goal of the study is to improve AGHD management through a Smartphone app (MAGHD App: Manage Adult Growth Hormone Deficiency) integrated with a software framework able to merge patients daily data on physical activity, quality of life (QoL), and well-being with clinical data collected in institutional databases. The target population consists of 100 patients with a previous diagnosis of AGHD, whether in treatment with growth hormone or not. In a prospective 24 months study, MAGHD App will be developed and connected to MAGHD Framework. This system will allow to integrate: 1) Physical Activity Data collected by wearable devices, 2) Patient Related Outcomes Data, periodically inserted by the patients through MAGHD App in response to questions extrapolated from validated questionnaires, 3) HCP Data registered in clinical databases and including medical history, biochemical and radiological examination. Data will converge in MAGHD Framework where they will be analyzed and used to create reports visible to patients (in MAGHD App) and clinicians (by a monitoring dashboard). The results are expected to positively influence AGHD management by involving patients in care process and giving clinicians a useful tool for clinical practice.

NCT ID: NCT03524092 Active, not recruiting - Ulcerative Colitis Clinical Trials

A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

LUCENT 2
Start date: October 19, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).

NCT ID: NCT03523858 Active, not recruiting - Clinical trials for Progressive Multiple Sclerosis (PMS)

A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

CONSONANCE
Start date: May 28, 2018
Phase: Phase 3
Study type: Interventional

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

NCT ID: NCT03523585 Active, not recruiting - Breast Cancer Clinical Trials

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

Start date: August 1, 2018
Phase: Phase 3
Study type: Interventional

This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: - cannot be removed by an operation - has spread to other parts of the body

NCT ID: NCT03523572 Active, not recruiting - Breast Cancer Clinical Trials

Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer

Start date: June 20, 2018
Phase: Phase 1
Study type: Interventional

This is a study of trastuzumab deruxtecan, which was approved by the FDA (in December 2019) for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens. Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab. The study will be done in two parts: - Part 1 is to identify the recommended dose to use for treatment. - Part 2 is to find out how well the combination works, and how safe and tolerable it is.

NCT ID: NCT03522246 Active, not recruiting - Clinical trials for Fallopian Tube Cancer

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

ATHENA
Start date: May 14, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.