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NCT ID: NCT02070783 Completed - Depression Clinical Trials

Cognitive and Neural Effects of ARA290

CONEARA
Start date: February 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Studies on the hormone Erythropoietin (EPO) have indicated that EPO may have antidepressant properties. However, EPO may cause serious side-effects with repeated administration (thrombosis), which limits its usefulness as an antidepressant. ARA290 is a peptide that does not have the effects of EPO on blood cells but may still have its effect on brain function. In an attempt to replicate previous findings with (a single dose of) EPO in healthy volunteers, we study the effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers. We hypothesize that a single dose of ARA290 will lead to a positive shift in information processing compared to placebo, 7 days post-administration.

NCT ID: NCT02070731 Completed - Clinical trials for Aortic Valve Stenosis

DEFLECT III: A Prospective, Randomized Evaluation of the TriGuardâ„¢ HDH Embolic Deflection Device During TAVI

TAVI
Start date: February 2014
Phase: N/A
Study type: Interventional

A randomized evaluation of the TriGuardâ„¢ HDH embolic deflection device during transcatheter aortic valve implantation.

NCT ID: NCT02070146 Recruiting - Colorectal Cancer Clinical Trials

Prospective Data Collection Initiative on Colorectal Cancer

PLCRC
Start date: May 2013
Phase:
Study type: Observational [Patient Registry]

Survival after colorectal cancer (CRC) diagnosis strongly depends on local tumor extent, lymph node involvement and the presence of distant metastases. However, there remains great inter-patient variability regarding treatment outcome. A combination of biochemical factors, histopathological features, genomic profile, environmental factors and other clinical factors are likely to influence prognosis and treatment effect, independent from tumor stage, but it is still unclear which, how, and to what extent these factors can influence tumor recurrence and mortality in both early stage (I-III) and late stage (IV) CRC, small bowel cancer and anal cancer. Although the results from prospective clinical trials will remain the backbone of evidence based medicine, this concerns a highly selected patient population since the large majority (85%-95%) of cancer patients do not participate in clinical trials for various reasons. It is unlikely that trial participation will significantly improve in the near future. This fact has the following implications: 1) It is highly desirable to validate the results from trials in the general patient population. However, this is complicated by the fact that the documentation of patients treated in general practice (i.e. outside the scope of clinical trials) is largely insufficient to provide comparable patient cohorts in terms of prognostic characteristics and treatment parameters. 2) There is an increased availability of novel technologies that provide molecular markers with potential prognostic and/or predictive value. To test the clinical value of these markers large numbers of patients are required which greatly exceeds the number of patients who consent to participate in prospective clinical trials. 3) as a result of rapid technical developments, a range of new minimally invasive treatment options are entering the market. These interventions have the potential to be of great benefit for patients in terms of improved local control, higher probability of complete tumor removal, less damage to surrounding tissue, faster recovery and less short and long term side effects. Still, the interventions will have to prove their effectiveness, safety and superiority (or non-inferiority) to standard cancer treatments on a patient level. A prospective observational cohort study has the great opportunity to fill this gap.

NCT ID: NCT02068781 Completed - Hypertension Clinical Trials

Aldosterone, Microvascular Function and Salt-sensitivity

Start date: July 2014
Phase: N/A
Study type: Interventional

Currently, the incidence of obesity and obesity-related disorders is reaching epidemic proportions, which entails an increasing burden for health care systems. The association of obesity with other risk factors for type 2 diabetes mellitus and cardiovascular disease, such as insulin resistance and hypertension, is often referred to as the metabolic syndrome. During recent years, salt-sensitivity of blood pressure has emerged as an additional cardiovascular risk factor that is related to obesity and other key components of the metabolic syndrome. The underlying pathophysiological mechanisms of these interrelationships are complex and incompletely elucidated. Microvascular dysfunction has been proposed as a link between insulin resistance and hypertension in obese individuals. In addition, impairment of microvascular function was found to be associated with salt-sensitivity of blood pressure. Increased aldosterone levels, as observed in obese individuals, might be a cause of microvascular dysfunction-induced salt-sensitivity and insulin resistance. Aldosterone not only gives rise to sodium-retention in the distal tubule of the kidney, but was also found to impair endothelial function and thus lower NO-availability, which is characteristic of microvascular dysfunction. In addition, elevated aldosterone levels are associated with both hypertension and insulin resistance, which is illustrated in patients with primary aldosteronism, but also in the general population. The investigators hypothesize that increased aldosterone levels in obese individuals lead to impairment of microvascular function through reduction of NO-availability. This microvascular dysfunction is suggested to play a central role in the pathogenesis of salt-sensitive hypertension and insulin resistance.

NCT ID: NCT02068001 Active, not recruiting - Clinical trials for Roux-en-Y Gastric Bypass

Changes in Food Preference and Food Cue Responsivity After Bariatric Surgery

Verrukkelijk
Start date: July 2014
Phase: N/A
Study type: Observational

It has been suggested that obese people are more sensitive to sensory and rewarding effects of food, aspects that mediate food preferences and intake. Individuals that underwent Roux-en-Y gastric bypass surgery frequently report changes in food preference. They indicate a decreased preference for highly rewarding energy dense foods. Changes in food preference might be related to alterations in central (brain) mechanisms, related to reward sensing. The smell and sight of food can be considered as anticipatory cues for the rewarding effects of food intake. The aim of this study is to determine the effect of gastric bypass surgery on (alterations in) food preferences. Secondly, this study aims at assessing the effect of gastric bypass surgery on the brain reward response when exposed to sight and smell of food stimuli with different sugar and fat contents.

NCT ID: NCT02067988 Completed - Clinical trials for Neuroendocrine Tumors

Holmium-166-radioembolization in NET After Lutetium-177-dotatate; an Efficacy Study

HEPAR_Plus
Start date: February 2014
Phase: Phase 2
Study type: Interventional

Patients with gastroenteropancreatic neuroendocrine tumours (NET) often die from intrahepatic disease or are excluded from liver-directed treatment because of extrahepatic disease. Adjuvant liver-directed treatment is warranted to control both intra- and extrahepatic disease. Patients with liver metastases of NET will be included in this study (n = 30-48).The efficacy and toxicity of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate will be studied in a non-comparative phase II study. The study is an interventional, treatment, non-randomized, open label, non-comparative, phase II study. 166Ho-RE will be performed via a catheter during angiography.

NCT ID: NCT02067936 Completed - Anesthesia Clinical Trials

Walking the Isobole of Drug Interaction

Walibi
Start date: February 2014
Phase: N/A
Study type: Interventional

The investigators study whether four equipotent combinations of propofol and remifentanil (as predicted by interaction models for "tolerance of laryngoscopy") result in identical haemodynamic conditions, independent of their relative different balance between the concentration of propofol and remifentanil.

NCT ID: NCT02067910 Completed - Sjögren's Syndrome Clinical Trials

Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome

ASAPIII
Start date: August 2014
Phase: Phase 3
Study type: Interventional

Primary Sjögren's syndrome (pSS) is a common chronic auto-immune disease, characterised by inflammation of the exocrine glands, resulting in progressive dryness of the eyes and the mouth. Furthermore, many patients experience extraglandular symptoms such as restricting fatigue. Currently, biological agents have been introduced in various systemic autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus. No biological agent has yet been approved for the treatment of pSS. In an open-label study, we have shown that abatacept treatment of pSS patients has promising results (Meiners et al., 2014). Therefore, the aim of this study is to evaluate efficacy and safety of subcutaneous abatacept treatment in pSS in a larger and randomized clinical trial.

NCT ID: NCT02067299 Completed - Clinical trials for Depressive Disorder, Major

A Study to Investigate the Effect of JNJ-42847922 on Polysomnography Measures in Patients With Major Depressive Disorder With Insomnia Who Are Stably Treated With Antidepressants

Start date: February 2014
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate effect of JNJ-42847922 on sleep latency (latency to persistent sleep) in participants with major depressive disorder who are stably treated with selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor who suffer from insomnia (inability to fall asleep).

NCT ID: NCT02066961 Completed - Prostate Cancer Clinical Trials

A Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-resistant Prostate Cancer and Men With Metastatic Prostate Cancer

ASPIRE-PCa
Start date: December 31, 2013
Phase:
Study type: Observational

The purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and trigger(s) for treatment changes and to document healthcare resource utilization used to manage treatment-related complications.