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NCT ID: NCT02352948 Completed - Clinical trials for Non - Small Cell Lung Cancer NSCLC

A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

ARCTIC
Start date: January 13, 2015
Phase: Phase 3
Study type: Interventional

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib [TARCEVA®]), gemcitabine or vinorelbine (NAVELBINE®)

NCT ID: NCT02352493 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-CC5 in healthy adult volunteers and subjects with PNH

NCT ID: NCT02352363 Completed - Clinical trials for Idiopathic Parkinson's Disease

Randomized Safety Study of CVT-301 Compared to an Observational Control Group

Start date: March 2015
Phase: Phase 3
Study type: Interventional

This study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will include a concurrent observational cohort of PD patients managed using the usual standards of care.

NCT ID: NCT02350842 Completed - Heart Failure Clinical Trials

Triple-site Biventricular Stimulation in the Optimization of CRT

TRIUMPH-CRT
Start date: July 2015
Phase: N/A
Study type: Interventional

Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the population do not respond to standard biventricular implantation. Non-response can be explained by a combination of factors including sub-optimal patient selection, placement of the pacing lead over a zone of slow conduction, insufficient correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data distinguish true non-responders from patients in which effective resynchronization was not delivered through standard biventricular implantation. Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation Therapy) CRT recipients.

NCT ID: NCT02350673 Completed - Solid Tumors Clinical Trials

A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors

Start date: June 29, 2015
Phase: Phase 1
Study type: Interventional

This is an open-label, multi-center, Phase Ib clinical study of cergutuzumab amunaleukin, in combination with atezolizumab, to investigate the safety, pharmacokinetics, and therapeutic activity in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive solid tumors, whose disease has progressed on or who are intolerant to the standard of care therapy. Enrolled participants who continue treatment will be treated until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. The study will include 2 parts: a dose-escalation Part I and a dose expansion Part II. The anticipated treatment period is 24 months for both cergutuzumab amunaleukin and atezolizumab and may be modified if emerging data suggest a benefit.

NCT ID: NCT02350582 Completed - Breast Cancer Clinical Trials

e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer

e-CUIDACHEMO
Start date: April 2012
Phase: N/A
Study type: Interventional

Patients with breast cancer undergo a series of psiclofisicas alterations during cancer treatment, chemotherapy phase being one of the more aggressive ete effect. These changes reduce the quality of life and result in a loss of physical health-related condition. Studies have shown that the practice of physical exercise and rehabilitation strategies enhance or attenuate the impact of chemotherapy on quality of life of patients. At present, technological development from telerehabilitación systems is a promising strategy that enables fast and efficient communication between health professionals and patients, especially at this stage of the disease where the patient may encounter difficulties in matching measures improving their lifestyle with aggressive medical treatment. To carry out this study a controlled study masked, parallel-group done were conducted usual care control group and an intervention based on a web system telerehabilitación to improve the physical condition associated with health and performed quality of life.

NCT ID: NCT02349295 Completed - Psoriatic Arthritis Clinical Trials

A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

SPIRIT-P2
Start date: December 31, 2014
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.

NCT ID: NCT02349061 Completed - Clinical trials for Lupus Erythematosus, Systemic

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

Start date: October 15, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active Active Systemic Lupus Erythematosus (SLE - chronic disorder of connective tissue in which there can be skin rash, arthritis, kidney problems, and anemia, among other problems).

NCT ID: NCT02348723 Completed - Atrial Fibrillation Clinical Trials

Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)

Start date: April 28, 2015
Phase: Phase 4
Study type: Interventional

The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study. Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting. It is not intended to assess confirmatory hypothesis, this is an exploratory study.

NCT ID: NCT02348489 Completed - Clinical trials for Leukemia, Myeloid, Acute

SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction

Start date: March 19, 2015
Phase: Phase 3
Study type: Interventional

To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.