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NCT ID: NCT02447081 Completed - Stroke Clinical Trials

Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)

Amulet™PMS
Start date: June 1, 2015
Phase:
Study type: Observational [Patient Registry]

This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."

NCT ID: NCT02445248 Completed - Clinical trials for Diffuse Large B-cell Lymphoma (DLBCL)

Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients

JULIET
Start date: July 29, 2015
Phase: Phase 2
Study type: Interventional

This is a multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory DLBCL.

NCT ID: NCT02445222 Recruiting - Clinical trials for Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

CAR-T Long Term Follow Up (LTFU) Study

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

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

NCT ID: NCT02445053 Completed - Cystic Fibrosis Clinical Trials

Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)

VOCAL
Start date: April 2015
Phase:
Study type: Observational

To describe the effectiveness of Kalydeco® treatment in patients with cystic fibrosis (CF) who have 1 of 8 non G551D gating CFTR mutations (G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D).

NCT ID: NCT02444962 Recruiting - Clinical trials for Prostheses and Implants

BioComp Implants in Anaplastology - Pilot Study

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

At the department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center (MUMC) the routine procedure after ablation of the nose, ear or eye is reconstruction with an episthesis. Retention can be achieved using adhesives, undercuts or bone implants. Implant based episthesis are now commonly used because of the good retention and episthesis stability. This results in a better patient quality of life. Today we use machined surface implants in the craniofacial region of different brands. Each system has its own instruments and application method. To enhance the clinical usability, we are searching for one system for all extra-oral implant regions. Furthermore, implant patients may be compromised by aging, diseases, smoking, medication and radiation therapy, which can affect the bone healing process. In these cases, implants are known to have higher failure rates compared to the application in healthy cases. Therefore implants with biomechanical surface modifications, such as the HAVD implants of BioComp, may have a positive effect on osseointegration, resulting in higher success rates in the compromised patient. The aim of this pilot study is to collect information about the functionality and safety of a surface treated implant system (HAVD, BioComp) for episthetic reconstruction after ablative surgery in the nasal, orbital and auricular region for a potential future RCT.

NCT ID: NCT02443298 Completed - Asthma Clinical Trials

Efficacy and Safety of BI 655066/ABBV-066 (Risankizumab) in Patients With Severe Persistent Asthma

Start date: June 23, 2015
Phase: Phase 2
Study type: Interventional

The objectives of this trial are primarily to evaluate the efficacy and safety of BI 655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with BI 655066/ABBV-066 (risankizumab).

NCT ID: NCT02442557 Completed - Multiple Sclerosis Clinical Trials

Safety and Dose-finding Study of DC-TAB in Healthy Subjects

Start date: December 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine safety and appropriate dose of DC-TAB for selective immune tolerance induction in humans.

NCT ID: NCT02442531 Completed - Cancer Clinical Trials

A Study of CriPec® Docetaxel Given to Patients With Solid Tumours

NAPOLY
Start date: August 2015
Phase: Phase 1
Study type: Interventional

The goal of this Phase1 clinical research study is to find the highest safe dose of CriPec® docetaxel that can be given in the treatment of patients with solid tumours.

NCT ID: NCT02442375 Completed - Clinical trials for Head and Neck Neoplasms

Uniform FDG-PET Guided Gradient Dose Prescription to Reduce Late Radiation Toxicity

UPGRADE-RT
Start date: June 2016
Phase: Phase 3
Study type: Interventional

The objective of the UPGRADE-RT trial is to investigate whether de-escalation of elective radiation dose and introduction of an intermediate dose-level in the treatment of head and neck cancer will results in less radiation sequelae and improved quality of life after treatment whilst the recurrence rate in electively irradiated lymph nodes should not be compromised. A summary of the study protocol can be found here: http://rdcu.be/qgMv

NCT ID: NCT02441946 Completed - Breast Cancer Clinical Trials

A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

neoMONARCH
Start date: August 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer.