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NCT ID: NCT01374711 Completed - Sepsis Clinical Trials

The Effects of Immunostimulation With GM-CSF or IFN-y on Immunoparalysis Following Human Endotoxemia

Start date: May 2011
Phase: N/A
Study type: Interventional

The human body knows a biphasic immunological reaction to sepsis. First, the pro-inflammatory reaction takes place, marked by the release of pro-inflammatory cytokines like TNF-α, as a reaction to the bacterial toxins. Secondly, the counter regulatory anti-inflammatory reaction arises. This phase is acting as negative feedback on the inflammation by inhibition of the pro-inflammatory cytokines. This is called "immunoparalysis", a pronounced immunosuppressive state, which renders patients vulnerable to opportunistic infections. Most of the septic patients survive the initial pro-inflammatory phase, but die during this second stage.Research in the past has shown that immunostimulatory therapy with GM-CSF or IFN-γ has promising effects on the pro-inflammatory reaction during immunoparalysis ex vivo. Both drugs are known for their immunostimulatory effects. Recent pilot studies have showed in septic patients, that long-lasting monocyte deactivation in sepsis ex vivo can be reversed by these two immunostimulants. However, the mechanism and extent of immunoparalysis recovery may be different between the two compounds. Previously it has been shown that human endotoxemia (induced by LPS), leads to marked immunosuppression in healthy individuals, characterized by a transient refractory state to a subsequent LPS challenge (endotoxin tolerance). Consequently, human endotoxemia can serve as a standardized, controlled model for sepsis-induced immunoparalysis. Until now, all studies have focused on the ex vivo tolerance. However, we have recently proved, that the ex vivo condition is not completely representative for the in vivo situation. Ex vivo, leukocyte tolerance to LPS resolves within one day, while the in vivo immunoparalysis persists for two weeks. In this project, we will investigate the effects of both GM-CSF and IFN-γ in a parallel double-blind placebo controlled randomized manner on the immunoparalysis following human endotoxemia, both in-vitro and in vivo. As a result, we hope to get more insight in the pathophysiology of sepsis-induced immunoparalysis and thereby develop new immunostimulatory therapies that improve patient outcome

NCT ID: NCT01374451 Completed - Islet Cell Tumor Clinical Trials

Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET

COOPERATE-1
Start date: June 2011
Phase: Phase 2
Study type: Interventional

This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET

NCT ID: NCT01373684 Completed - Chronic Hepatitis B Clinical Trials

PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients

PAS
Start date: May 25, 2012
Phase: Phase 4
Study type: Interventional

This study intends to investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with nucleos(t)ide analogues enhances the degree of HBsAg decline.

NCT ID: NCT01373515 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

Leukemic Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia

Start date: April 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label phase 1 feasibility and safety dose escalation study. The main objective is to evaluate the safety of DCP-001 intradermal vaccination in patients with AML.

NCT ID: NCT01373151 Completed - Clinical trials for Rheumatoid Arthritis

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate

Start date: June 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

NCT ID: NCT01371812 Completed - Asthma Clinical Trials

GSK2239633 FTIH Study

Start date: March 29, 2011
Phase: Phase 1
Study type: Interventional

The purpose of this first time into human study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK2239633 in healthy male subjects.

NCT ID: NCT01371201 Completed - Clinical trials for Malignant Progressive Pheochromocytoma and Paraganglioma (PPGL)

First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma

FIRSTMAPPP
Start date: December 22, 2011
Phase: Phase 2
Study type: Interventional

The FIRSTMAPPP study is a randomized, double-blind, phase II, international, multicenter study which aims to determine the efficacy of Sunitinib on the progression-free survival at 12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated with sunitinib at a starting dose of 37.5 mg daily (continuous dosing).

NCT ID: NCT01371162 Completed - Clinical trials for Hepatitis C, Chronic, Healthy Volunteer

A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C

Start date: June 2011
Phase: Phase 1
Study type: Interventional

This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).

NCT ID: NCT01370837 Completed - Diabetes Mellitus Clinical Trials

Neurogenic Inflammation in Diabetes

Start date: May 2012
Phase: N/A
Study type: Interventional

Polyneuropathy is a complication of diabetes mellitus which leads to decreased sensation in arms and legs. This in turn can lead to the development of (infected) foot ulcers. Charcot's disease can also be a consequence of polyneuropathy. Patients with Charcot's disease suddenly develop a red, warm and swollen foot, like an infection. Charcot's disease leads to foot fractures. After these fractures have healed, the shape of the foot can be dramatically altered. This altered shape of the foot increases the risk of developing foot ulcers. Nerves are important in regulating the inflammatory response. This study aims to investigate whether the inflammatory response is different in patients with polyneuropathy with and without a history of Charcot's disease.

NCT ID: NCT01370824 Completed - Clinical trials for Basal Cell Carcinoma

Clinical Diagnosis of Basal Cell Carcinoma Subtype

Start date: June 2011
Phase: N/A
Study type: Observational

Skin cancer is the most common cancer in Caucasians. Basal cell carcinoma (BCC) is the most frequent skin cancer with around 44.000 new tumours per year in the Netherlands, and its incidence is still rising. Prior to treatment, a punch biopsy (PB) is taken from the suspected lesion, in order to determine the subtype of BCC. There are three different histological subtypes of BCC, from least to most aggressive: superficial, nodular and aggressive. Based on the most aggressive subtype seen in the PB, a suitable surgical margin is chosen. Surgical excision (SE) is the treatment of first choice in all BCC subtypes according to the Dutch guidelines. Recent developments of non-invasive therapies for superficial BCC might be the first choice of treatment in the future. These non-invasive treatments (photodynamic therapy (PDT), Imiquimod and 5-fluorouracil (5-FU)) have better cosmetic results than SE and are therefore also used in the Maastricht University Medical Center. Drawback is a higher recurrence rate than SE. As nodular and aggressive subtypes grow deeper into the dermis, they have to be treated with SE with a 3 mm and 5 mm margin respectively. If BCC are located in the H-zone, the treatment will be Mohs micrographic surgery (MMS). Unfortunately, 30% of subtypes seen in the PB do not correspond with the subtype seen in the subsequent SE/MMS. The consequence is overtreatment and undertreatment. A potential better or equal way to determine the BCC subtype might be the clinical diagnosis. To our knowledge, there is no literature about the diagnostic value of the clinical diagnosis to determine the subtype of BCC seen in the SE/MMS specimen. We want to confirm the hypothesis that the clinical diagnosis is as good as, or even better than the histological diagnosis by PB to determine the BCC subtype in the subsequent SE/MMS. In this case, patients don't have to undergo an extra procedure, diagnostic route is shortened. - Primary objective: to establish the observed agreement of clinical diagnosis compared to histological diagnosis by to determine the most aggressive subtype of BCC - Secondary objectives: inter-observer and intra-observer variability of dermatologists and pathologists to determine subtype BCC.