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NCT ID: NCT02279862 Completed - Prostate Cancer Clinical Trials

Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive

Start date: December 2, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.

NCT ID: NCT02278887 Active, not recruiting - Metastatic Melanoma Clinical Trials

Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma

TIL
Start date: September 23, 2014
Phase: Phase 3
Study type: Interventional

In this randomized controlled phase III study the investigators will evaluate whether TIL infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus interleukin-2 can result in an improved progression free survival when randomly compared to ipilimumab in 168 stage IV melanoma patients. A health technology assessment (HTA) will be performed to evaluate the impact of the TIL treatment on patients and organizational processes and cost-effectivity.

NCT ID: NCT02278718 Active, not recruiting - Thermal Burns Clinical Trials

A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care

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

This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).

NCT ID: NCT02278653 Active, not recruiting - Rectal Neoplasms Clinical Trials

Functional Outcome of Organ Preservation After Neo-adjuvant Chemo Radiation for Rectal Cancer

Start date: March 2014
Phase:
Study type: Observational [Patient Registry]

The primary objective is to describe the functional outcome of patients that choose for organ saving treatment.

NCT ID: NCT02278640 Completed - Clinical trials for Benign Disease Where Total Hysterectomy is Indicated

Harmonic ACE®+7 Shears in Laparoscopic Hysterectomy

Start date: October 2014
Phase: Phase 4
Study type: Interventional

This is a prospective, non-randomized, single arm, multicenter, study to assess the initial clinical experience with the Harmonic ACE®+7 Shears by evaluating vessel sealing during total laparoscopic hysterectomy. The study will not modify or influence current surgeon technique. Investigators will perform each procedure using the device in compliance with their standard surgical approach and product labeling. The Harmonic ACE®+7 Shears is cleared for commercial distribution and will be used in accordance with approved product labeling. The Harmonic ACE®+7 Shears will be assembled, calibrated, and/or used in accordance with manufacturer design specifications, product instructions and guidelines

NCT ID: NCT02278250 Completed - Solid Tumor Clinical Trials

First in Human Study of M4344 in Participants With Advanced Solid Tumors

Start date: January 26, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study was to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced solid tumors. This investigation is a three part study examining M4344 alone and in combination with carboplatin to determine the safety and maximum tolerated dose.

NCT ID: NCT02278133 Completed - Clinical trials for Metastatic Colorectal Cancer

Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations

Start date: December 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions. The design of this study is based upon the translational and pre-clinical data that suggest that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor activity.

NCT ID: NCT02277990 Completed - Clinical trials for CIED Related Infection

World-wide Randomized Antibiotic Envelope Infection Prevention Trial

WRAP-IT
Start date: January 2015
Phase: Phase 4
Study type: Interventional

Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.

NCT ID: NCT02277717 Completed - Solid Tumors Clinical Trials

First-in-human Study With the Antibody-drug Conjugate SYD985 to Evaluate Safety and Efficacy in Cancer Patients

Start date: October 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of a new medicinal drug SYD985 at different dose levels in patients with cancer, to understand how SYD985 is handled by the body and to evaluate the effect of SYD985 on the cancer.

NCT ID: NCT02277470 Recruiting - Ulcerative Colitis Clinical Trials

Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis

GO-KINETIC
Start date: August 2014
Phase: N/A
Study type: Observational

The purpose of this study is to gain insights in the pharmacokinetics of golimumab in moderate to severe Ulcerative Colitis after subcutaneous administration, during induction and maintenance treatment the investigators will collect blood and stool samples at different time points.