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NCT ID: NCT01998152 Completed - Clinical trials for Stage IV Colorectal Cancer

Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)

COLONUT
Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose is to study the effect of individualized nutritional counselling compared to usual nutritional care on cross-sectional muscle area in patients with stage IV colorectal cancer during first line chemotherapy. Secondary, effect on total lean body mass, treatment intensity, physical functioning, quality of life and survival will be studied.We hypothesize that patients in the intervention arm benefit from individualized nutritional counseling.

NCT ID: NCT01997892 Completed - Anemia Clinical Trials

TRANSFORM - Observational Cohort Study of Darbepoetin Alfa Use in European Union (EU) Hemodialysis Patients Switched From PEG Epoetin Beta

TRANSFORM
Start date: August 2012
Phase: N/A
Study type: Observational

To describe the time course of hemoglobin concentration in EU hemodialysis patients switched from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa (Aranesp).

NCT ID: NCT01997229 Completed - Clinical trials for Refractory Generalized Myasthenia Gravis

Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)

Start date: December 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.

NCT ID: NCT01996995 Completed - Onychomycosis Clinical Trials

Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications

LASER-1
Start date: March 2015
Phase: N/A
Study type: Interventional

In a sham controlled double-blind trial we aim to establish the efficacy and safety of local application of laser therapy in patients with diabetes with onychomycosis and risk factors for diabetes related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn leads to increased local pressure. The combination of onychomycosis and neuropathy or peripheral arterial disease (PAD) increases the risk of developing diabetes related foot complications. Usual care for high-risk patients with diabetes and onychomycosis is completely symptomatic with frequent skiving and clipping of the nails. No effective curative local therapies exist and systemic agents are often withheld due to concerns for side effects and interactions. Aim: The primary aim is to evaluate the efficacy of 4 sessions N-YAG 1064nM laser application on the one-year clinical and microbiological cure rate in a randomised, double-blinded sham-controlled design with blinded outcome assessment. Study population: Patients with diabetes mellitus, with an increased risk for diabetic foot ulcers. Intervention: local laser treatment from a podiatrist and the other group receives treatment according to a control procedure. The laser procedure will be performed as a sham procedure by a second podiatrist. Main study parameters/endpoints: The effect of 4 sessions of laser therapy on cure rate (clinical and microbiological) after one year.

NCT ID: NCT01996735 Completed - Healthy Clinical Trials

Ticagrelor and Adenosine

Start date: April 2013
Phase: Phase 4
Study type: Interventional

Preclinical studies have shown that the P2Y12 receptor antagonist ticagrelor can increase the extracellular concentration of the endogenous nucleoside adenosine by inhibiting the cellular uptake of adenosine via the equilibrative nucleoside transporter (ENT). This mechanism can contribute to the beneficial effects and to the side effects (dyspnea) of ticagrelor in patients with an acute myocardial infarction. In the current research proposal, we aim to investigate whether ticagrelor increases adenosine receptor stimulation in humans in vivo by ENT inhibition.

NCT ID: NCT01995981 Completed - Clinical trials for Sarcoma, Soft Tissue

Individualizing Pazopanib Therapy by exploRing the Role of Early Metabolic responsE and Drug Exposure as a preDICTor for Treatment Outcome in Patients With STS

PREDICT
Start date: December 2013
Phase: N/A
Study type: Observational

This study is a phase IV post registration prospective observational feasibility study in patients with metastatic soft tissue sarcoma. Pazopanib is the registered treatment for patients with advanced soft tissue sarcoma after chemotherapy with doxorubicin or ifosfamide. - This study looks at the possibility of using 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography PET scans as an early biomarker of pazopanib treatment effect in patients. - It also studies pazopanib pharmacokinetics to see if there are differences between elderly and younger patients. The primary objectives are: - To evaluate whether early metabolic response is correlated to clinical benefit. - To evaluate the effect of age (≥ 70 years) on pazopanib pharmacokinetics. The secondary objectives are: - To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib therapy) is correlated with pazopanib exposure. - To evaluate whether early metabolic response (% decrease in FDG uptake due to pazopanib therapy) is correlated with the histological subtypes.

NCT ID: NCT01995487 Completed - Clinical trials for Coronary Artery Stenosis

Study of BioNIR Drug Eluting Stent System in Coronary Stenosis

BIONICS
Start date: January 2014
Phase: N/A
Study type: Interventional

The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion failure (TLF) at 12 months; that it is non-inferior to the Resolute for the secondary endpoint of angiographic in-stent late loss at 13 months; and that it is more cost-effective.

NCT ID: NCT01995240 Completed - Pancreatic Cancer Clinical Trials

Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study

REMP
Start date: April 2013
Phase: N/A
Study type: Interventional

Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at an early stage. Preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. Several MR techniques can serve for this purpose. However, optimalisation of these techniques is needed and their reproducibility should be assessed.

NCT ID: NCT01995084 Completed - Pancreatic Cancer Clinical Trials

In Vivo Assessment of Hypoxia in Gastro-intestinal Cancer Using 18F-HX4-PET: an Optimization and Reproducibility Study

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

Several studies have shown that tumour hypoxia may have a negative impact on the outcome of anticancer treatment. Assessment of tumor hypoxia at baseline or shortly after start of treatment may serve as a predictive marker to determine treatment efficacy at an early stage. Preferably, such an assessment is performed in vivo and non-invasively.Non-invasive imaging with positron emission tomography (PET) using the 2-nitroimidazole nucleoside analogue, 3-18F-fluoro-2-(4-((2-nitro-1H-imidazol-1-yl)methyl)-1H-1,2,3-triazol-1- yl)propan-1-ol (18F-HX4), was tested as a new marker of tumor hypoxia. Before hypoxia-measurements can be clinically implemented for response prediction, the reproducibility of the technique should be assessed for each specific tumor type. Knowledge of reproducibility is needed to determine what change in parameters between two examinations can be considered relevant in an individual patient. Assessment of reproducibility becomes even more important in early response monitoring since the changes in the tumor induced by the treatment may be smaller during the treatment compared to response monitoring after completion of treatment. Also, as image quality of 18F-HX4-PET increases with increasing time intervals after injection, determination of the optimal time point for measurement of hypoxia is warranted.

NCT ID: NCT01994889 Completed - Clinical trials for Transthyretin (TTR) Amyloid Cardiomyopathy

Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy

ATTR-ACT
Start date: December 9, 2013
Phase: Phase 3
Study type: Interventional

This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.