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NCT ID: NCT01638143 Completed - Bioequivalence Clinical Trials

Bio-equivalence Study

Start date: November 2010
Phase: N/A
Study type: Interventional

The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.

NCT ID: NCT01638000 Completed - Urologic Diseases Clinical Trials

A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

BEYOND
Start date: June 12, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

NCT ID: NCT01637532 Completed - Clinical trials for Recurrent Ovarian Cancer

Feasibility of the Combination of Chemotherapy (Carbo/Caelyx or Carbo/Doxorubicin) With Tocilizumab (mAb IL-6R) and Peg-Intron in Patients With Recurrent Ovarian Cancer

PITCH
Start date: February 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this interventional study is to determine the feasibility to combine standard chemotherapy (Carbo/Caelyx or doxorubicin) for recurrent ovarian cancer with immunotherapy (Tocilizumab and Peg-Intron). This study combines standard chemotherapy Carboplatin-Caelyx or doxorubicin with a monoclonal antibody against IL-6R (tocilizumab). High IL-6 levels correlate with poor prognosis and chemoresistance in ovarian cancer patients. In cases of chemoresistant ovarian cancer, therefore, modulation of the IL-6 pathway, by blocking the IL-6 receptor, may represent a promising strategy to both abolish drug resistance and amplify host immunity in patients with recurrent ovarian cancer. Blockade of the IL-6/IL-6R pathway may enhance immunogenic cell death and restore local normal DC maturation. In addition, the use of interferon-alpha (Peg-Intron) allows the full maturation of DC, thereby enhancing the anti-tumor response.

NCT ID: NCT01637272 Completed - Clinical trials for Dumping Syndrome Patients

Intra-patient Dose Escalation Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide (SOM230) Subcutaneous (s.c.) Followed by Pasireotide LAR in Patients With Dumping Syndrome

Start date: January 2013
Phase: Phase 2
Study type: Interventional

multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome

NCT ID: NCT01637181 Completed - Varicose Veins Clinical Trials

Clinical Trial of Endovenous 940 and 1470 Laser Ablation for Treating Great Saphenous Veins

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

A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA) techniques in patients with insufficiency of the great saphenous vein (GSV). There are multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm Diode and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also proven to be equally effective in occluding the GSV. However, little is known about differences in patient-related outcomes. Therefore, the primary outcomes of this comparative clinical trial of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores of health related and varicose-specific questionnaires. The secondary outcomes are complications and effectiveness of the treatment. It is thought that possibly the 1470 nm ELVA will give lower pain scores and higher patient satisfaction than 940 nm EVLA. No differences are expected in complication rate and effectiveness between the two treatments.

NCT ID: NCT01636908 Completed - Cancer Clinical Trials

Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.

ICK
Start date: August 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.

NCT ID: NCT01636479 Completed - Neoplasm Malignant Clinical Trials

Phase 1 Safety Testing of SAR405838

Start date: July 13, 2012
Phase: Phase 1
Study type: Interventional

Primary Objectives: - To determine safety and the maximum tolerated dose (MTD) of SAR405838 through the characterization of dose-limiting toxicities (DLTs). - To assess biological activities in patients with dedifferentiated liposarcoma during MTD cohort expansion. Secondary Objectives: - Pharmacokinetic (PK) profile of SAR405838. - Biomarkers in association with SAR405838. - Anti-tumor activity in response to SAR405838. - Food effect on SAR405838 PK. - Compliance with SAR405838 treatment. - Cytochrome P450 3A4/5 (CYP3A4/5) activity.

NCT ID: NCT01635829 Completed - Clinical trials for Healthy Participants

A Study to Investigate the Potential Pharmacokinetic Interactions Between Phenytoin or Carbamazepine and Telaprevir

Start date: May 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the potential pharmacokinetic (what the body does to the drug) interactions between multiple doses of phenytoin 200 mg every 12 hours or carbamazepine 200 mg every 12 hours and telaprevir 750 mg every 8 hours at steady-state (constant concentration of medication in the blood) in healthy participants.

NCT ID: NCT01634906 Completed - Atherosclerosis Clinical Trials

Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy

EBABAST
Start date: July 2012
Phase: N/A
Study type: Interventional

Background: preliminary data have shown that erythrocyte-bound apolipoprotein B (ery-apoB) may be protective against atherosclerosis. However, statins may have an effect on ery-apoB. Objective: to investigate the effect of statins on ery-apoB levels. Study design: a non-randomized intervention study. Ery-apoB will be measured twice in volunteers who are on statin therapy for medical reasons. After a baseline measurement of ery-apoB volunteers will discontinue their statin use for a period of six weeks followed by a second measurement of ery-apoB. Consecutively subjects will start with their original statin therapy again. Study population: patients on statin therapy aged 18 years or older. Intervention: temporary discontinuation of statin therapy for a period of six weeks. Main study endpoints: changes in ery-apoB levels. Risks, burden and benefits on participation: volunteers will visit the outpatient clinic twice, the second visit will be exactly six weeks after the first visit. The volunteers' general practitioner and medical specialist (internist or cardiologist) will be informed about their participation. Subjects have to fast for 10 hours before every visit and venous blood samples will be drawn on both visits (a total of 36ml of blood). Subjects will discontinue their usual statin therapy for a period of six weeks. No major risks are involved with temporary discontinuation of statin therapy in stable chronic cardiovascular disease. Volunteers will receive 25 euro's in total for participation. Participation serves to further investigate the relation of statins and potentially beneficial binding of apoB on erythrocytes.

NCT ID: NCT01634711 Completed - Clinical trials for Complete Tear, Knee, Anterior Cruciate Ligament

Clinical Evaluation of a Resorbable PLLA Implant for Regeneration of the Anterior Cruciate Ligament (ACL)

Start date: June 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety of a resorbable polymer implant (Soft Tissue Regeneration's L-C Ligament) for replacement and regeneration of the anterior cruciate ligament (ACL). Approximately 15 patients at 2-3 different hospitals in Europe will participate in this study. The hypothesis of this study is that the L-C Ligament will successfully regenerate the ACL with clinical outcomes similar to or better than surgical intervention with auto graft tissue.