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NCT ID: NCT01764633 Completed - Dyslipidemia Clinical Trials

Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk

FOURIER
Start date: February 8, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

NCT ID: NCT01763983 Completed - Multiple Sclerosis Clinical Trials

Effects of Cognitive Behavioural Therapy and Exercise on Stress and Cognitive Deficits in Multiple Sclerosis

Start date: January 2013
Phase: N/A
Study type: Interventional

High levels of psychological stress have been reported by 90% of patients with MS experiencing disease exacerbation, and approximately 39% of those with more stable disease course. These stress levels are comparable to patients with a clinical diagnosis of major depression. Cognitive dysfunction affects approximately 40% of community surveyed MS patients, and stress may exacerbate the cognitive burden. Studies have shown that Cognitive Behavior Therapy (CBT) is effective in treating psychological stress. Studies have also shown that exercise is beneficial to mood and cognitive function. Therefore the proposed study will test the comparative benefits of combining CBT and Exercise as an intervention for stress and cognitive dysfunction in MS subjects. The 2 active treatment conditions will be compared with a waitlist control condition. There are 4 broad aims to this study: 1) to compare the relative efficacy of CBT, Exercise, and CBT-Exercise for stress in MS, 2) to examine the extent to which neuropsychological features of stress and MS, especially working memory and executive functioning, improve following treatments, 3) to determine the extent to which neuropsychological factors are associated with successful treatment response and improved quality of life, and 4) to determine if combined CBT-Exercise confers greater benefits on measures of stress and neuropsychological functioning compared with Exercise alone. The study hypotheses are: 1) All active treatment conditions will lead to significantly greater improvement on measures of stress at post-treatment and follow-up compared to waitlist controls, 2) Combined CBT-Exercise will lead to comparatively greater symptom reduction compared to all other conditions at post-treatment and follow-up assessments on measures of stress, 3) All active treatment conditions will lead to significant improvement in neuropsychological functioning (particularly measures of working memory and executive functioning) at post-treatment compared to controls, and 4) Combined CBT-Exercise will lead to greater improvement in neuropsychological functioning compared to all other conditions at post-treatment. The study design allows for examination of the potential additive benefits of CBT and Exercise to usual therapy for patients, and its feasibility as a viable treatment model for MS outpatient clinics and community-based intervention programs. This study will shed light on the treatment of sub-threshold symptoms that are strikingly common in MS population, but often overlooked in favour of more concrete diagnoses (e.g. major depression disorder). This proposed study will also be the first to determine whether evidence-based non-medical treatments for stress and mood disturbances in MS reduce underlying cognitive substrates associated with the illness and known to be exacerbated by stress.

NCT ID: NCT01763918 Completed - Hyperlipidemia Clinical Trials

Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

RUTHERFORD-2
Start date: February 7, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).

NCT ID: NCT01763905 Completed - Hyperlipidemia Clinical Trials

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

GAUSS-2
Start date: January 24, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).

NCT ID: NCT01763866 Completed - Hyperlipidemia Clinical Trials

LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2

LAPLACE-2
Start date: January 15, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

NCT ID: NCT01763827 Completed - Hyperlipidemia Clinical Trials

Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2

MENDEL-2
Start date: January 21, 2013
Phase: Phase 3
Study type: Interventional

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

NCT ID: NCT01763164 Completed - Clinical trials for Metastatic or Unresectable Cutaneous Melanoma

Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma

Start date: July 12, 2013
Phase: Phase 3
Study type: Interventional

Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival

NCT ID: NCT01762124 Completed - Clinical trials for Congenital Heart Disease

Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)

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

The purpose of this early feasibility study is to determine how a new transcatheter pulmonary valve will move and perform once implanted in the right ventricular outflow tract.

NCT ID: NCT01762098 Completed - Infertility Clinical Trials

Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization

Start date: November 2012
Phase: N/A
Study type: Observational

Chronic endometritis is a persistent inflammation of the endometrium. Chronic endometritis is asymptomatic or little symptomatic. Sometimes, patient with chronic endometritis can have genital bleeding, pelvic chronic pain, pain during sexual relations, persistent vaginal white loosing. The hysteroscopy can detect the presence or absence of chronic endometritis. Some studies showed that the endometritis could have an impact on the embryo implantation and could explain recurrent miscarriages or repeated embryo implantation failures. The goal of this study is to evaluate the frequency of the chronic endometritis in patients with recurrent miscarriages or repeated embryo implantation failures

NCT ID: NCT01762020 Completed - Breast Cancer Clinical Trials

Barrier Film vs. Standard Skin Care in Preventing Dermatitis in Women With Breast Cancer Receiving Radiation

Start date: January 2013
Phase: Phase 3
Study type: Interventional

To evaluate the effectiveness of preventing Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer.