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NCT ID: NCT01655069 Completed - Clinical trials for Urinary Bladder, Overactive

A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076

LEOPARD
Start date: October 4, 2012
Phase: Phase 3
Study type: Interventional

This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).

NCT ID: NCT01652469 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.

EMPHASIS
Start date: August 2012
Phase: Phase 3
Study type: Interventional

Using a laboratory test (VeriStrat), patients with relapsed squamous cell lung cancer are assigned to two strata, VSG (VeriStrat Good) and VSP (VeriStrat Poor). They are then randomized between an EGFR-TK inhibitor (erlotinib) and chemotherapy (Docetaxel). It is hypothesized that the VeriStrat test results are able to predict the benefit of treatment with erlotinib vs docetaxel. This would suggest a significant improvement in progression-free survival for VSG patients when treated with Erlotinib, and no significant improvement in VSP patients who receive the same treatment.

NCT ID: NCT01644188 Completed - Clinical trials for Hypercholesterolemia

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

Start date: August 2012
Phase: Phase 3
Study type: Interventional

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points - To evaluate the effect of alirocumab on other lipid parameters - To evaluate the safety and tolerability of alirocumab

NCT ID: NCT01640262 Completed - Prostatic Neoplasms Clinical Trials

Evaluation of Modern MRI in the Diagnosis of Prostate Cancer in a Danish Setup

Start date: August 2011
Phase: N/A
Study type: Observational

Clinical staging of prostate cancer in Denmark is determined solely by digital rectal examination and sometimes by TRUS, even though the investigators know these examinations are inaccurate and have limitations. Since the majority of men diagnosed with prostate cancer will die with their disease and not of their disease, and the different treatment-options may imply greater side effects, it is important to improve the diagnostic localization and staging of the tumour for optimal clinical management and therapy selection. The development of modern multiparametric-high-field-magnetic-imaging (mMRI) offers new possibilities and approaches in detection, localization and staging of prostate cancer due to its high resolution and soft-tissue contrast. mMRI can provide information about the morphological, metabolic and cellular changes and characterize tissue- and tumour- vascularity and correlate it with tumour aggressiveness. This helps to locate and stage a possible tumour and to guide targeted-biopsies towards disease-suspicious areas. Internationally published data support the rapidly growing use of multiparametric MRI, as being the most sensitive and specific imaging tool for prostate cancer patients. While mMRI internationally is a well recognized and accepted method for detection, localization and staging of prostate cancer, the use of mMRI in the diagnosis of PCa in Denmark has never been applied. Therefore, this project is carried out in order to evaluate the use of modern mMRI in the diagnosis of prostate cancer in a Danish setup.

NCT ID: NCT01640145 Completed - Sarcopenia Clinical Trials

Effect of Low Intensity Exercise and Protein Intake on Skeletal Muscle Protein Synthesis in Elderly

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

Maintenance of skeletal muscle mass is crucial during lifespan to retain health and functional autonomy. Sarcopenia, being the loss of muscle mass during aging, is a well-known phenomenon in the elderly and a major challenge viewed from an individual, and a socioeconomic point of view. Nevertheless, several studies have proved muscle tissue to be markedly affected by physical activity and nutritional interventions even at old age. Recently, a study in young individuals showed that an acute bout of easily tolerated low intensity exercise can prolong the muscle building effects of a milk protein intake compared to a non-exercised situation. Therefore, the major aim of the present project is to evaluate, whether a low intensity exercise regime in conjunction with milk protein supplementation can induce positive adaptations on parameters related to muscle size and function in elderly. The study focuses on the acute muscle protein synthesis response to low intensity exercise and protein supplementation measured with stable isotope tracer techniques. It is hypothesized that light muscle activity can augment and prolong the effects of protein feeding. If a light resistance exercise protocol as investigated in the present project can prove beneficial, elderly, frail elderly, and individuals undergoing rehabilitation can challenge sarcopenia in a new and tolerable way.

NCT ID: NCT01638962 Completed - Clinical trials for Osteoarthritis, Knee

The Effect on Knee Joint Loads of Analgesic Use Compared With Exercise in Patients With Knee Osteoarthritis - An RCT

EXERPHARMA
Start date: August 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effects of neuromuscular exercise and analgesic use on knee joint load, in patients with mild to moderate knee osteoarthritis (OA). It is expected that the two groups will receive equipotent pain relieving effect, despite this, the investigators expect a between group difference in knee joint load, and the exercise group will have a reduction in knee joint load.

NCT ID: NCT01638663 Completed - Clinical trials for Cardiovascular Diseases

Effect of the Aquaretic Tolvaptan on Nitric Oxide System (TORA)

Start date: May 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of tolvaptan on renal water, sodium and potassium excretion, plasma concentration of vasoactive hormones,central blood pressure, pulse wave velocity (PWV) and augmentation index, basal and during inhibition of nitric oxide synthesis in healthy subjects.

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: NCT01637662 Completed - Migraine Clinical Trials

Natriuretic Peptide's Headache Inducing Characteristics and Effects on the Cerebral Blood Flow

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

To investigate headache score and accompanying symptoms during and after infusion of the natriuretic peptides.

NCT ID: NCT01637363 Completed - Clinical trials for Stress, Psychological

Psychoeducation to Sick-listed Individuals With Mental Health Problems

Start date: September 2012
Phase: N/A
Study type: Interventional

In Denmark, it is estimated that 35-45% of all sick leave registered citizens are on sick leave due to psychiatric sufferings. Mental health conditions are of great consequence not only to the sick-listed individual but also to his/her family and to society in general and in socioeconomic terms. The aim of this project is to systematically compare psychoeducation with the various standard offers to sick listed individuals with mental health conditions provided by job centers in four municipalities. Psychoeducation is employed within the psychiatric healthcare system and is defined as a group based treatment by means of educating participants about psychiatric conditions. In the present project, the employed psychoeducation focuses on psyche and work life, and its purpose is to impart knowledge about psychiatric conditions in order to provide the sick listed individuals with qualifications to understand, and, thereby, improve their own situation. Among others, there will be information about the symptoms of various psychiatric conditions, diagnoses, and treatment options. Furthermore, the participants will learn about specific, useful, cognitive tools in regards to the barriers and difficulties they might experience when reentering the work force and leave sickness absence behind. The project is designed as a randomized clinical trial in which the participants are offered either 1) psychoeducation as well as the standard offer to sick listed individuals provided by the municipality in which the individual lives or 2) the participants are offered merely the standard offer to sick listed individuals provided by the municipality. The target group consists of recently sick listed individuals with mental health issues - whether diagnosed or not. The individuals must be inhabitants of the municipalities of Struer, Lemvig, Skive, and Holstebro. The outcome measure is the determined as the duration of the sickness absence, the severity of the psychiatric condition, self-reported health, and `locus of control´. These outcome measurements are assessed at baseline and after 3 and 6 months.