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NCT ID: NCT01504581 Completed - Healthy Clinical Trials

Safety, Pharmacokinetic, Pharmacodynamic Study of LAPS-IFNa in Healthy Adult Subjects

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

Study design: This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4 groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a single dose of a currently marketed PEG-interferon.

NCT ID: NCT01504022 Recruiting - Hypertension Clinical Trials

Web Based Interactive Treatment and Self-monitoring in Hypertension

WISH
Start date: September 2011
Phase: N/A
Study type: Interventional

The WISH-trial is an open-label, parallel-group, randomized controlled trial. The effects of self-measuring of the blood pressure at home and the use of a pro-active web-based feedback system on the blood pressure, number of antihypertensive drugs used, and surrogate cardiovascular markers during a 12 month period will be investigated.

NCT ID: NCT01502696 Active, not recruiting - Ulcerated Melanomas Clinical Trials

Adjuvant PEG Intron in Ulcerated Melanoma

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

Patients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk. The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.

NCT ID: NCT01501955 Completed - Clinical trials for Osteoarthritis of the Hip

The Metaphyseal Hip Prosthesis - Total Hip

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

The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement.

NCT ID: NCT01501552 Completed - Alcoholism Clinical Trials

Trial Testing the Effect of Strategies on Performance of Brief Intervention Programmes for Harmful Alcohol Consumption

ODHIN_RCT
Start date: January 2012
Phase: N/A
Study type: Interventional

The overall objective is to study if training and support, financial reimbursement and referral to an internet based brief intervention programme, singly or in combination, may increase implementation of evidence based methods of identification and brief intervention for excessive alcohol consumption in routine primary health care.

NCT ID: NCT01500694 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder (ADHD)

Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe

Start date: March 20, 2012
Phase: Phase 3
Study type: Interventional

For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl (SPD503).

NCT ID: NCT01500486 Completed - Clinical trials for Growth Hormone Disorder

Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™

Start date: January 2007
Phase: N/A
Study type: Observational

This study is conducted in Europe. The aim of this study is to evaluate ease of injection of growth hormone in patients using Norditropin NordiFlex® with NordiFlex PenMate™. Convenience and tolerability of NordiFlex PenMate™ - an automatic injection and a needle hiding device - is also evaluated.

NCT ID: NCT01500239 Completed - Clinical trials for Complicated Intra-Abdominal Infection

A Study Comparing Ceftazidime-Avibactam+Metronidazole Versus Meropenem in Adults With Complicated Intra-abdominal Infections

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

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.

NCT ID: NCT01499979 Completed - Clinical trials for Hepatic Ischemia-reperfusion Injury

Hypothermic Perfusion During Hemihepatectomy

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

Rationale Currently, hepatic resection is often the only curative treatment for primary or secondary hepatic malignancies and is also frequently performed in patients with benign liver tumors to prevent malignant transformation and/or alleviate symptoms. Liver resections are nowadays associated with low mortality and acceptable morbidity. As result of that, an increasing number of patients is currently under consideration for resection of more complex or large tumors, thus requiring extensive resection procedures. Application of vascular exclusion (i.e., clamping of the portal vein and hepatic artery) during such procedures reduces blood loss, which is one of the most important factors affecting peri-operative outcomes. However, vascular exclusion leads to ischemia-reperfusion (I/R) injury as an inevitable side-effect, which adversely impacts postoperative liver function and regeneration. Additional cooling of the liver by means of hypothermic perfusion is expected to further reduce intraoperative blood loss, as well as to protect the liver from I/R injury. Therefore, the aim of this pilot study is to cool the future remnant liver (FRL) in situ during right hemihepatectomy under vascular exclusion. Consequently, an overall improvement in postoperative outcomes is expected due to a decrease in intraoperative blood loss, reduced parenchymal damage, and a better ability of the liver remnant to regenerate. Objective To reduce intraoperative blood loss and enhance tolerance of the FRL to I/R injury during right hemihepatectomy under vascular exclusion by means of in situ hypothermic perfusion with retrograde outflow (R-IHP) of the FRL. Study design The study is designed as a prospective randomized pilot study in 18 patients (9 interventions and 9 controls) to assess the effects of the proposed intervention. Additionally, 4 patients will be included separately for assessment of the intervention's feasibility prior to randomized inclusion. Study population Eligible patients for participation in this study are those planned to undergo right hemihepatectomy under vascular inflow occlusion because of a malignant or benign liver tumor, and who do not suffer from any hepatic co-morbidity that might influence postoperative outcomes (i.e., severe steatosis, cholestasis, cirrhosis, or hepatitis B/C infection). Intervention During right hemihepatectomy, the FRL of patients allocated to the intervention group will be perfused with a chilled perfusion solution (i.e., lactated Ringer's solution).

NCT ID: NCT01499797 Completed - Overall Functioning Clinical Trials

The CareWell-programme for Community-dwelling Frail Elderly Persons.

CareWell
Start date: January 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of the CareWell-programme on overall functioning of community-dwelling frail elderly persons. Furthermore, the total costs and the cost-effectiveness of the CareWell-programme, in comparison with regular medical care, will be studied.