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NCT ID: NCT02227082 Completed - Clinical trials for Locally Advanced Malignant Neoplasm

Olaparib and Radiotherapy in Inoperable Breast Cancer

Start date: October 21, 2013
Phase: Phase 1
Study type: Interventional

The majority of breast cancer patients receive radiotherapy as part of their treatment. Radiotherapy improves both locoregional control and overall survival. In most patients with breast cancer the locoregional recurrence rate (LRR) is low, however still high LRRs are found in certain patient groups, especially in locally advanced, inflammatory and triple negative breast cancer. Olaparib is a potent PARP inhibitor developed as an anti-cancer drug for homologous recombination (HR) defected tumors and as a dose intensifier for chemo- and radiotherapy. The combination of olaparib and radiotherapy is expected to improve locoregional control and thereby overall survival in both breast cancer patients with a high probability of locoregional recurrence and patients with HR deficient tumors. However, this combination treatment has never been tested in humans before. The purpose of this study is to determine the safety and tolerability of radiotherapy to the breast and regional lymph nodes with concurrent olaparib.

NCT ID: NCT02226757 Not yet recruiting - NSCLC Clinical Trials

Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients

Start date: August 2014
Phase: Phase 2
Study type: Interventional

This study is a pilot study in EGFR-mutated NSCLC patients who have progressed on standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2 expression, patients can participate in the trial after obtaining informed consent. Patients will be treated with weekly paclitaxel-trastuzumab.

NCT ID: NCT02226198 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia (HoFH)

A Study to Evaluate the Efficacy and Safety of Rosuvastatin in Children and Adolescents With Homozygous Familial Hypercholesterolemia

HYDRA
Start date: November 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to establish the efficacy, safety and tolerability of rosuvastatin in children and adolescents with homozygous familial hypercholesterolemia.

NCT ID: NCT02226120 Completed - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction

Start date: October 16, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.

NCT ID: NCT02225821 Completed - Clinical trials for Surgical Wound Infection

Wound Infections Following Implant Removal

WIFI
Start date: November 2014
Phase: Phase 4
Study type: Interventional

In the Netherlands about 18,000 surgical procedures with implant removal are annually performed after fracture healing, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWIs) should be less than 5%. However, rates of 10-12% following implant removal, specifically after foot, ankle and lower leg fractures are reported. Currently, surgeons decide individually if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. Therefore, the investigators propose a double-blind randomized controlled trial (RCT) in patients scheduled for implant removal following a foot, ankle or lower leg fracture, to assess the (cost-)effectiveness of a single gift of antibiotic prophylaxis. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome at 30 days and 6 months after implant removal and costs. With 2 x 250 patients a decrease in POWI from 10% to 3.3% (expected rate in clean-contaminated elective orthopedic trauma procedures) can be detected (Power=80%, 2-sided alpha=5%, including 15% lost to follow up). If the assumption of the investigators, that prophylactic antibiotics prior to implant removal reduces the infectious complication rate, is confirmed by this RCT, this will offer a strong argument to adopt a single gift of antibiotic prophylaxis as standard practice of care. This will reduce the incidence of POWIs and consequently will lead to less physical and social disabilities and health care use. In addition, it will decrease the rate of use of empiric broad-spectrum antibiotics (and antibiotic resistance) prescribed upon suspicion or diagnosis of a POWI. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of €3.5 million per year.

NCT ID: NCT02225392 Completed - Asthma Clinical Trials

Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma

TASMA
Start date: April 2014
Phase: N/A
Study type: Interventional

Approximately 5% of asthma patients suffer from severe asthma that is characterized by frequent asthma exacerbations resulting in significant morbidity and excessive utilisation of health care resources. Therefore, there is a strong need for improved therapeutic strategies for these patients. Insight in the pathogenesis and molecular pathways active in severe asthma is crucial to reach this goal. Bronchial Thermoplasty (BT) is a novel, innovative device-based treatment of severe asthma that is based on local, radiofrequent energy delivery in larger airways during bronchoscopy. Hypothesis: BT-induced clinical improvement in severe asthma is a consequence of reduction in airway smooth muscle (ASM) mass and (contractile/immunomodulatory) function, inflammation, neural innervation and/or vascular integrity resulting in altered airway remodelling. BT target identification and severe asthma phenotyping are critical for improved patient selection for BT and fundamental to discover novel, specific signalling pathways active in severe asthma.

NCT ID: NCT02224703 Completed - Epilepsy Clinical Trials

GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

Start date: April 13, 2015
Phase: Phase 3
Study type: Interventional

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

NCT ID: NCT02224690 Completed - Epilepsy Clinical Trials

A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults

GWPCARE4
Start date: April 28, 2015
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of GWP42003-P as adjunctive treatment in reducing the number of drop seizures when compared with placebo, in participants with Lennox-Gastaut Syndrome (LGS).

NCT ID: NCT02224469 Completed - Locked-In Syndrome Clinical Trials

First Study With a Brain Implant to Help Locked-in Patients Communicate at Home

UNP
Start date: September 9, 2015
Phase: N/A
Study type: Interventional

In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completely implantable system. These brain signals are fed wirelessly into an assistive technology device and will control this device for communication and environmental control at the users home.

NCT ID: NCT02222415 Completed - Clinical trials for Gaining Skeletal Muscle Mass and Strength

Exercise Training in Healthy Young Men

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

Resistance type exercise training has been shown to be a potent stimulus to increase skeletal muscle mass and strength in healthy men. Furthermore, timed protein intake is also known to affect the muscle adaptive response following exercise. Whether timed protein intake could augment the increase in muscle fiber size and/or satellite cell content following long-term exercise intervention remains to be established. We hypothesize that protein supplementation before sleep, on both training and non-training days, during a 12 week resistance training program further increases type II muscle fibre cross sectional area when compared to the placebo group.