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NCT ID: NCT01399346 Completed - Type 1 Diabetes Clinical Trials

Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes

Start date: April 2011
Phase: Phase 1
Study type: Interventional

Rationale: For the development of a closed loop system, faster insulin absorption after bolus administration could help to reduce the system's delay and thus increase patient safety. It has been shown that regular insulin absorption is faster when injecting insulin with a sprinkler needle (containing holes in the walls and being sealed at the tip). The current study will evaluate the impact of different application volumes on pharmacokinetic and pharmacodynamic properties of rapid acting insulin analogue (insulin aspart). Objective: To compare the pharmacokinetic response (based on the time to maximum observed serum insulin concentration) and pharmacodynamic properties of rapid acting insulin aspart after subcutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in patients with type 1 diabetes. Study design: Monocentric, randomised, controlled, two-arm cross-over intervention study. Population: Twelve type 1 diabetic subjects Intervention: The investigational treatment is the subcutaneous administration of insulin aspart either as one bolus of 18 IU at one injection site or as 9 separately and simultaneously applied bolus of 2 IU each at 9 separate injection sites. Serum and plasma samples to assess pharmacodynamic and pharmacokinetic properties will be taken during an 8-hour clamp experiment. Patients will undergo both investigational treatments in a randomized order; between the two clamp visits there will be a wash-out period of 5-21 days. Main study endpoint: Time to maximum observed serum insulin aspart concentration.

NCT ID: NCT01397409 Completed - Clinical trials for Age-related Macular Degeneration

Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)

Start date: September 1, 2011
Phase: Phase 2
Study type: Interventional

This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.

NCT ID: NCT01395810 Completed - Clinical trials for Congenital Bleeding Disorder

Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773

paradigmâ„¢ 4
Start date: April 15, 2012
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B. This trial is an extension to trials NN7999-3747 (NCT01333111/paradigmâ„¢ 2) and NN7999-3773 (NCT01386528/paradigmâ„¢ 3).

NCT ID: NCT01395212 Completed - Clinical trials for Acute Myocardial Infarction

MYSTAR-5-YEAR: Long-term Follow-up of Patients With Ischemic Heart Disease Treated With Cell Therapy

MYSTAR-5-YEAR
Start date: July 2011
Phase: N/A
Study type: Observational

The MYSTAR-5-YEAR study controls the patients 5 years after treatment with combined (intramyocardial and intracoronary) delivery of autologous BM-MNCs. The clinical endpoint of this prospective non-randomized observational study is the MACCE, defined as major adverse cardiac and cerebrovascular events. Patients will be investigated by echocardiography, SPECT and MRI. 2D (NOGA-guided SPECT) and 3D (NOGA-guided MRI) imaging will refine the evaluation with more exact analysis of the intramyocardial injected areas (ROI).

NCT ID: NCT01395017 Completed - Pancreatic Cancer Clinical Trials

Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

LAPC
Start date: June 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.

NCT ID: NCT01394757 Completed - Healthy Volunteers Clinical Trials

Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging (phMRI)

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

Alterations of functional brain networks have been frequently demonstrated in schizophrenia, although the exact underlying molecular mechanisms remain unrevealed. Ketamine is known to exert its schizophrenia-like effects through modulation of the glutamatergic system, thus facilitating the investigation of the impact of this specific transmitter system on resting state functional brain networks. The aim of the study is therefore to use pharmacological functional Magnetic Resonance Imaging (phMRI) to examine changes in brain networks involved in schizophrenia in response to ketamine application compared to placebo. 30 healthy subjects (15 females) will be examined twice using a double-blind, placebo-controlled, randomized, crossover, counterbalanced-order design. Resting state fMRI will be investigated before, during and after either placebo or ketamine intravenous infusion for 20 minutes. Prior to the main trial 10 additional participants will be included in an open pilot trial. Hypothesis: Ketamine application will induce changes in resting state networks previously associated with schizophrenia and in the connectivity of relevant brain regions such as the striatum, thalamus, caudate, hippocampus and amygdala. Furthermore, the application of ketamine will provoke changes in the BOLD-activation in three fMRI paradigms each performed before and after ketamine infusion.

NCT ID: NCT01394445 Completed - Postoperative Pain Clinical Trials

Pilot Study of Physostigmine-Enhanced Opioid Analgesia

PHANOS
Start date: June 2011
Phase: Phase 3
Study type: Interventional

The investigators hypothesize that the administration of physostigmine in the postoperative period after nephrectomy reduces opioid consumption.

NCT ID: NCT01393899 Completed - Crohn's Disease Clinical Trials

The Safety And Efficacy Of Maintenance Therapy With CP-690,550

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

This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.

NCT ID: NCT01393626 Completed - Crohn's Disease Clinical Trials

A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

Start date: October 2011
Phase: Phase 2
Study type: Interventional

This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).

NCT ID: NCT01392612 Completed - Hypertension Clinical Trials

Erythropoietin and Platelet Activation Markers

Start date: November 2006
Phase: Phase 4
Study type: Interventional

We hypothesized that the effect of erythropoietin may be reflected by changes in thromboxane B2 (TXB2) and endothelial cell function. Six male and six female subjects received recombinant human epoetin alpha (Erypo®) intravenously (300 Units per kg). Biomarker levels were assessed at baseline and 4, 24, 48 and 72 hours after administration.