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NCT ID: NCT01998256 Completed - Quality of Life Clinical Trials

Clinical Benefit of Rigourous AV Delay Optimization in Patients With a Dual Chamber Pacemaker

CBRAVO
Start date: December 2013
Phase: N/A
Study type: Interventional

Though AV optimization has become a cornerstone in optimization of patients with a cardiac resynchronization therapy (CRT) device, surprisingly the use of AV optimization in patients with a dual chamber (bicameral (BIC)) pacemaker is not fully implemented in daily clinical practice. Some patients with a BIC pacemaker have a too short AV delay (AVD), secondary to an important interatrial conduction delay (IACD), which can lead to an atrial dyssynchrony syndrome. Others have a too long AV delay, also leading to a suboptimal diastolic filling time. Some patients may not need an optimization. Our aim was to evaluate the effect of AV optimization in all comer ambulatory patients with a BIC pacemaker on clinical outcomes, with a correlation to atrial pathophysiology, since until now existing evidence only emphasizes a possible hemodynamic benefit of this non invasive intervention.

NCT ID: NCT01998074 Completed - Food Sensitivity Clinical Trials

Evaluation of the Efficacy of a New Formula in Infants With Cow's Milk Protein Allergy

Paradice
Start date: n/a
Phase: N/A
Study type: Interventional

The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.

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: NCT01997632 Completed - Poliomyelitis Clinical Trials

Phase 1 Study on the Safety and Reactogenicity of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) Given Intramuscularly Compared to Standard Trivalent Inactivated Poliovirus Vaccine (IPV) in Healthy Adults

IPV-004
Start date: November 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate if the study vaccine, m-IPV2 HD (vaccine that only contains polio serotype 2 in high dose), is as safe as the standard IPV Imovax (that contains the 3 serotypes of polio). This safety evaluation will be done in young adults. If the study vaccine appears to be safe, it will be tested at a later stage in the target group (infants and children) to evaluate the immunogenicity of the vaccine. After all, the purpose is to use the study vaccine in the future to protect young children against Polio serotype 2. Disease with Polio type 2 indeed recently re-appeared, so vaccination of young children to come to a complete eradication of Polio is needed. The standard use of Imovax to protect against Polio serotype 2 would be too expensive. Therefore, a monovalent Polio vaccine containing only serotype 2 (= the vaccine that will be evaluated in this study), has been developed. The duration of the study will be approximately 6 months. 120 subjects between 18 and 45 years of age will participate in Belgium. During the study there will be 2 groups of subjects. Subjects will be assigned by chance to one of these groups. One group will receive one single injection of the study vaccine m-IPV2 HD (which contains only serotype 2), the other group will receive one single injection of the standard polio vaccine IPV, Imovax (which contains the 3 serotypes). After this vaccination, there will be a follow-up period of 6 months. Subjects will be asked to come to the study centre one more time for the second visit (on Day 8, which is 7 days after the first visit). They will also receive 2 follow-up phone calls for approximately one month and 6 months after vaccination.

NCT ID: NCT01997606 Completed - Allergic Rhinitis Clinical Trials

House Dust Mite Allergen Reduction in Bedding: Purotex Impregnated Covers of Bekaert Textiles

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

Product information: Purotex is a textile treatment that uses five 100% natural bacteria or probiotics, selected for their ability to clean up house dust mite allergen along with other allergen types. Study design: - Placebo-controlled: the effect of the Purotex impregnated mattress and pillow covers will be compared to untreated, classical bedding covers (placebo). - Cross-over design: There will be 2 'treatment' arms. One arm (Arm 1) in which the subjects will first use the Purotex impregnated covers (Set A=Purotex) during 2 months (=period A) and, after a wash out period of 1 month, the untreated covers (set B=placebo) during 2 months (=period B). In the second arm (Arm 2), the subjects will first use the untreated set (set A=placebo) and, after a wash out period the Purotex impregnated covers (set B=Purotex). - Randomized: The subjects will be randomly assigned to one of the 2 treatment arms. - Double blind: both the subjects and the investigators will not know to which treatment arm the subjects are assigned. Study hypothesis: We want to investigate: - if there is a reduced concentration of HDM allergen in Purotex covers compared to untreated covers in real life - if patients with allergic rhinitis to house dust mite use the Purotex covers, they experience an improvement of their quality of life and sleep, and an improvement of their allergic symptoms and global discomfort

NCT ID: NCT01997333 Completed - Clinical trials for Metastatic gpNMB Over-expressing Triple Negative Breast Cancer

Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer

METRIC
Start date: November 2013
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.

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: NCT01995591 Completed - Colon Cancer Clinical Trials

Indocyanine Green (ICG) in the ex Vivo Detection of Sentinel Lymph Node (SLN)in Colon Cancer

2068
Start date: January 2013
Phase: N/A
Study type: Observational

Evaluation of the possibility to detect sentinel lymph node(s) after ex vivo Indocyanine Green injections around the tumour in pieces of colectomy from patients with colon cancer.

NCT ID: NCT01995513 Completed - Prostate Cancer Clinical Trials

Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

PLATO
Start date: October 22, 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

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.