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NCT ID: NCT01219699 Completed - Clinical trials for Estrogen Receptor Positive Breast Cancer

A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

Start date: October 5, 2010
Phase: Phase 1
Study type: Interventional

This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. A combination of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type PIK3CA gene

NCT ID: NCT01219218 Completed - Clinical trials for Refractory Angina Pectoris

Extracorporeal Shockwave Therapy for the Treatment of Advanced Angina Pectoris

Start date: January 2009
Phase: Phase 1
Study type: Interventional

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones. The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

NCT ID: NCT01218893 Completed - Clinical trials for Plasmodium Falciparum Malaria

Immunization With Different Doses of Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis

ZonMw1
Start date: April 2011
Phase: N/A
Study type: Interventional

Malaria is one of the major infectious diseases in the world with a tremendous impact on the quality of life significantly contributing to the ongoing poverty in endemic countries. It causes almost one million deaths per year, the majority of which are children under the age of five. The malaria parasite enters the human body through the skin, by the bite of an infected mosquito. Subsequently, it invades the liver and develops and multiplies inside the hepatocytes. After a week, the hepatocytes burst open and the parasites are released in the blood stream, causing the clinical phase of the disease. As a unique opportunity to study malaria immunology and efficacy of immunisation strategies, a protocol has been developed in the past to conduct experimental human malaria infections (EHMIs). EHMIs generally involve small groups of malaria-naïve volunteers infected via the bites of P. falciparum infected laboratory-reared Anopheline mosquitoes. Although potentially serious or even lethal, P. falciparum malaria can be radically cured at the earliest stages of blood infection where risks of complications are virtually absent. The investigators have shown previously that healthy human volunteers can be protected from a malaria mosquito (sporozoite) challenge by immunization with sporozoites (by mosquito bites) under chloroquine prophylaxis (CPS immunization). However, it is unknown how many mosquito bites are necessary to confer protection. Moreover, as all volunteers were protected in this study, no correlates of protection could be established. For future development of vaccines and understanding of protective immunity to malaria, it is important to investigate the lowest dose of CPS immunization that confers 100% protection and to find correlates of protection. Therefore, the present study aims to make the CPS immunization protocol more sensitive by lowering the number of infected mosquito bites, in order to study the underlying mechanisms of protection.

NCT ID: NCT01218672 Completed - Clinical trials for Benign Prostatic Hyperplasia

Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPH

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

The study compares procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. The study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE marked monopolar or bipolar loop TURP system for the treatment of benign prostatic hyperplasia (BPH).

NCT ID: NCT01218425 Completed - Clinical trials for Episodic Memory Consolidation

Dopaminergic Modulation of Cognition and Psychomotor Function

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

A recent study at our lab showed increased episodic memory consolidation and response readiness after treatment with methylphenidate in healthy volunteers. The investigators seek to replicate and extend these findings. Furthermore the pharmacological specificity of these effects will be studied. Since methylphenidate has an effect on two neurotransmitters, dopamine and noradrenaline, either could be responsible for the observed effects. In order to explore the dopaminergic contribution to this effect, the study proposed here includes not only methylphenidate but also levodopa/carbidopa, which only affects dopamine and not noradrenaline. In this study, 20 healthy males and females between 18 and 45 years of age will participate. They will be recruited via advertisements at Maastricht University and in local newspapers. Participants will be treated once with methylphenidate, once with levodopa/carbidopa and once with placebo. All medications will be administered orally with a capsule. It is hypothesized that methylphenidate and levodopa/carbidopa will both enhance episodic memory consolidation and improve response readiness

NCT ID: NCT01217671 Completed - Emphysema Clinical Trials

International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With Emphysema

Start date: December 2009
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomised , placebo controlled, double blind , multicentre, Phase II/III study evaluating the safety and efficacy of Kamada AAT for inhalation in patients with Emphysema caused by Alpha-1 Antitrypsin (AAT) deficiency.

NCT ID: NCT01217502 Completed - Hearing Loss Clinical Trials

Self-management for Dual Sensory Impaired

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

This study aims to determine the effectiveness of a self-management program for elderly with an acquired and concurrent hearing and visual impairment due to age-related disease processes.

NCT ID: NCT01217476 Completed - Clinical trials for Diabetic Foot Ulcer of Neuropathic Origin

The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North Study

TRANS-North
Start date: December 2010
Phase: Phase 3
Study type: Interventional

Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent for solution and a spray part to fit the glass bottle after reconstitution of the final product. We conduct a multinational, randomized, double-blind, placebo controlled, parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after a maximum of 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients will be randomized and it is planned that this study will be conducted at approximately 40 investigational sites in Europe.

NCT ID: NCT01217307 Completed - Clinical trials for Coronary Artery Disease

Metformin to Reduce Heart Failure After Myocardial Infarction

GIPS-III
Start date: January 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators will evaluate the effect of metformin therapy during 4 months in non-diabetic patients following ST-elevation myocardial infarction on left ventricular ejection fraction as measured with cardiac magnetic resonance imaging, compared to placebo.

NCT ID: NCT01216995 Completed - Clinical trials for Acute Myocardial Infarction

Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI)

ADVANCE
Start date: September 2012
Phase: Phase 2
Study type: Interventional

Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).