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NCT ID: NCT02456714 Completed - Cholangiocarcinoma Clinical Trials

Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma

4CC
Start date: May 31, 2016
Phase: Phase 2
Study type: Interventional

Cholangiocarcinoma, is a malignant gastrointestinal tumor of low incidence with a poor prognosis. Chemotherapy is the most common treatment for advanced disease. On the basis of a phase III clinical study, cisplatin plus gemcitabine is considered standard first-line treatment in advanced cholangiocarcinoma patients, but there is no established second line therapy. Since fluorouracil and leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) appears to be safe and demonstrated efficacy in clinical studies of advanced pancreatic cancer, colorectal cancer and a phase I study in cholangiocarcinoma, this combination could be an effective second-line treatment for patients with advanced cholangiocarcinoma.

NCT ID: NCT02456480 Completed - Atopic Dermatitis Clinical Trials

Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

Start date: May 2015
Phase: Phase 2
Study type: Interventional

To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients with mild to moderate atopic dermatitis (AD).

NCT ID: NCT02456103 Terminated - Cystic Fibrosis Clinical Trials

Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis

Start date: August 31, 2015
Phase: Phase 3
Study type: Interventional

This is an open-label extension study for participants who completed a Phase 3, placebo-controlled study of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.

NCT ID: NCT02455180 Completed - Sepsis Clinical Trials

Pharmacokinetics of Two Different High-dose Regimens of Intravenous Vitamin C in Critically Ill Patients

Start date: March 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the pharmacokinetic properties of two different dosage regimens of intravenous vitamin C in patients admitted to the Intensive Care Unit with life-threatening illness.

NCT ID: NCT02454790 Recruiting - Esophageal Cancer Clinical Trials

Standard Follow-Up Program (SFP) for Patients With Esophageal Cancer

SFP OES
Start date: September 2014
Phase:
Study type: Observational [Patient Registry]

Motive: In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from esophageal cancer patients. Goal: To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life. A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.

NCT ID: NCT02453984 Active, not recruiting - Clinical trials for Locally Advanced or Metastatic Solid Tumors Irrespective of PD-L1 Expression

MPDL3280A-imaging-IST-UMCG

Start date: February 24, 2016
Phase: N/A
Study type: Interventional

By performing a 89Zr-MPDL3280A-PET scan prior or during treatment with MPDL3280A, the uptake of the tracer in the primary and metastatic tumor lesions and normal organ distribution can be evaluated, as well as the use of a 89Zr-MPDL3280A-PET as a complementary tool for patient selection and MPDL3280A- target saturation during treatment.

NCT ID: NCT02453776 Completed - Clinical trials for Inflammatory Bowel Disease

Precision Dosing of Infliximab Versus Conventional Dosing of Infliximab

PRECISION
Start date: May 2015
Phase: Phase 4
Study type: Interventional

Infliximab (IFX) is highly effective in inducing and maintaining remission in patients with inflammatory bowel disease (IBD). However, a large proportion of patients will eventually lose response to IFX. Therefore, strategies to improve the outcome of maintenance treatment with IFX are required. Retrospective analyses suggest that adjusting IFX treatment in order to achieve IFX trough levels (TL) above a well-defined therapeutic threshold will improve the outcome of IFX treatment.

NCT ID: NCT02453412 Completed - Clinical trials for Kidney Failure, Chronic

Preoperative Arteriovenous Fistula Simulation Study (ShuntSimulationStudy)

3S
Start date: May 2015
Phase: N/A
Study type: Interventional

Patients suffering from end-stage renal disease (ESRD) are dependent on renal replacement therapy (dialysis). The majority of dialysis is facilitated by hemodialysis. For hemodialysis a vascular access is necessary, preferable an arteriovenous fistula (AVF) in which a vein is directly anastomosed to an artery. In order to use the AVF for hemodialysis three criteria have to be met; the minimal flow over the AVF is 600 mL/min, the diameter is at least 6 mm, and the AVF is located less than 6 mm under the skin. Unfortunately, approximately half of the patients (50%) are confronted with an AVF that does not meet these criteria; the so called non-maturation or primary failure. In case of non-maturation the AVF is not only unusable for dialysis, but also requires reinterventions on short- and long-term. Firstly to mature the AVF, and secondly, when the AVF is matured, to keep the vascular access. Using a computational simulation postoperative flow can be predicted. Based on patient-specific duplex measurements, the model can calculate the flow that can be expected following vascular access surgery for all AVF configurations; fore- or upper arm. These calculations lead to an advice which configuration is indicated; a flow that exceeds 600 mL/min, leading to maturation. Potentially the aforementioned 50% of non-maturation can be reduced. The patient then has an adequate vascular access and reinterventions are adverted, resulting in a decrease of costs, hospital demand, and an increase of the patients' quality of life. When the expected reduction of non-maturation is confirmed, the computational tool can be offered to other hospitals.

NCT ID: NCT02453282 Active, not recruiting - Clinical trials for Non-Small-Cell Lung Carcinoma NSCLC

Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)

MYSTIC
Start date: July 21, 2015
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC

NCT ID: NCT02453256 Completed - Systemic Sclerosis Clinical Trials

A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)

focuSSced
Start date: November 20, 2015
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.