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NCT ID: NCT01475825 Completed - Clinical trials for Hypercholesterolemia

A Study of the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients With Familial Hypercholesterolemia and Inadequately Controlled Low-Density Lipoprotein Cholesterol

FOCUS FH
Start date: December 2011
Phase: Phase 3
Study type: Interventional

Primary objective: Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as low-density lipoprotein cholesterol (LDL-C) levels ≥200 mg/dL plus the presence of coronary heart disease (CHD)/risk equivalents or LDL-C levels ≥300 mg/dL regardless of the presence of CHD/risk equivalents (referred to as Cohort 1) compared to placebo. Two different mipomersen dosing regimens will be studied: subcutaneous (SC) mipomersen 200 mg once weekly versus placebo, and SC mipomersen 70 mg thrice weekly versus placebo. Secondary Objectives: - Determine whether there are qualitative differences between the safety profiles of the 2 dosing regimens and placebo in Cohort 1, patients with HeFH with LDL-C levels ≥160 mg/dL and <200 mg/dL plus the presence of CHD/risk equivalents (referred to as Cohort 2), and the overall study population - Determine whether there are qualitative differences between the tolerability of the 2 dosing regimens and placebo in Cohort 1, Cohort 2, and the overall study population - Further characterize the pharmacokinetics (PK) of the 2 dosing regimens in Cohort 1, Cohort 2, and the overall study population - Determine whether the 2 mipomersen dosing regimens significantly reduce atherogenic lipid levels in Cohort 2 compared to placebo - Obtain additional data regarding ongoing safety and efficacy of mipomersen in patients with FH and inadequately controlled LDL-C who complete the primary efficacy assessment visit (PET) in the Blinded Treatment Period and continue treatment in Open-Label Continuation Period

NCT ID: NCT01475175 Terminated - Heart Failure Clinical Trials

Adaptive Cardiac Resynchronization Therapy Optimization at Rest and During Exercise (AdOPT CRT)

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

The AdOPT Cardiac Resynchronization Therapy (CRT) study is an acute, prospective, multi-center, non-randomized investigational study designed to compare indices of cardiac function at device settings optimized using the investigational Adaptive CRT (aCRT) algorithm versus nominal programming. The comparison will be performed during rest, atrial pacing and sub-maximal exercise. AdOPT CRT is a sub study of the Adaptive CRT Study (NTC00980057) being conducted in Europe.

NCT ID: NCT01474408 Completed - Clinical trials for Myocardial Infarction

Venous Function in Cardiovascular Disease Patients

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

The primary aim is to determine the acute effect of two different training interventions on venous plasticity in patients with myocardial infarction (MI), revascularization or coronary artery graft surgery compared to age-matched healthy subjects.

NCT ID: NCT01473810 Completed - HIV Infection Clinical Trials

Intranasal Modified Vacc-4x Gag Peptides With Endocine as Adjuvant

Start date: November 2011
Phase: Phase 1/Phase 2
Study type: Interventional

HIV-specific cellular immunity is hampered in most HIV-infected individuals. Therapeutic immunization in HIV aims to strengthen the HIV-specific cellular immunity, usually in the absence of replicating HIV with antiretroviral drugs. The aims of this strategy can be to decrease the mass of latently infected CD4+ T cells, better tolerance of drug-free periods, and better select candidates for preventive HIV vaccines. Vacc-4x is one of the few peptide-based therapeutic vaccines tested, and consists of four, slightly modified HIV Gag p24 consensus peptides. Vacc-4x was first tested by intradermal injections using GM-CSF as adjuvant. A recent multinational placebo-controlled study found improvement of vaccine-specific T cell immunity and decrease in viral loads (presented at the AIDS vaccine 2011 conference, Bangkok). In this study the investigators hypothesize that the Vacc-4x peptides, deposited on the nasal mucosal surfaces in conjunction with Endocine, a newly developed and documented mucosal adjuvant, will induce T cell responses to HIV and improve HIV-specific immunity both systemically and at mucosal surfaces (oral, rectal, vaginal).

NCT ID: NCT01473589 Completed - Femur Neck Fracture Clinical Trials

Effect of Teriparatide on Hip Fracture Healing

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

The purpose of this study is to see whether teriparatide, given for 6 months versus placebo, will improve the healing of hip (femoral neck) fractures that are repaired during surgery using certain types of orthopedic screws. The study will enroll men and postmenopausal women at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for example, fall from standing height or less).

NCT ID: NCT01473446 Terminated - Clinical trials for Postoperative Complications

Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients

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

Is goal directed fluid therapy reducing postoperative complications in comparison to traditional fluid therapy for gastro surgical ASA III/IV patients? The investigators compare two groups of patients: one group receives goal directed fluid therapy guided by LiDCOrapid stroke volume variation (SVV), the other gets the "traditional" fluids, ie the current regime.

NCT ID: NCT01473082 Completed - Hip Fractures Clinical Trials

Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

Start date: February 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be mobilized than patients without augmentation.

NCT ID: NCT01470963 Completed - Clinical trials for Quality of Health Care

Practical Health Co-operation - The Impact of a Referral Template on Quality of Health Care

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

The purpose of this study is to examine whether the implementation of a referral template will increase quality of health care delivered and the quality of health care co-operation. The investigators intent to implement a referral template, at the level of the general practitioner (GP), for the referral of patients within 4 separate diagnostic groups: - dyspepsia/upper GI symptoms - colonic cancer investigation/lower GI symptoms - chronic obstructive pulmonary disease (COPD) - chest pain Local GP clinics will be randomised to use the referral template or to use standard referral practice. Using a predefined set of quality criteria the investigators will score the process of care in each patient, and compare intervention and control groups. In addition other criteria will be collected and compared between the two groups, e.g. - time to diagnosis/treatment - quality of referral - more appropriate referrals - patient satisfaction (as measured by a questionnaire) The investigators hypothesize that the implementation of a referral template will lead to a measurable increase in the quality of health care delivered.

NCT ID: NCT01470456 Completed - Clinical trials for Diffuse Large B-Cell Lymphoma

Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

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

Primary Objective: Participants Achieving an Objective Response Rate (Cheson 2007) Secondary Objectives: - Progression Free Survival - Overall Survival - Response Duration

NCT ID: NCT01470274 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Safety of the CO-rebreathing Method in Stable Coronary Artery Disease and COPD Patients

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

The primary objective is to establish the safety of the CO-rebreathing method for measuring total blood and plasma volume in CAD patients. The working hypothesis is that the CO-rebreathing method is safe in use with coronary artery disease patients and that it does not cause myocardial ischemia or cardiovascular damage.