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NCT ID: NCT01477788 Withdrawn - Ovarian Neoplasm Clinical Trials

Prediction of Ovarian Malignancy in the Presence of Sonographic Pelvic Mass

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

The objective of the study is to create a test that will discriminate between malignant and benign ovarian mass that was diagnosed by ultrasound. The investigators will examine about 800 women and at the end of the study the investigators will combine data from the woman's history, the sonographic characters of the mass and serum biological markers along with the woman's outcome (which means - whether the mass was malignant, benign, or disappeared or remained constant with no intervention).

NCT ID: NCT01476956 Completed - Clinical trials for Rheumatoid Arthritis

Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

Start date: October 2011
Phase:
Study type: Observational

Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy. Disease activity will be monitored systematically every 3 months by the Disease Activity Score. Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be made according to specific recommendations for patients receiving these therapies. Biomarker samples will be collected every 3 months and prior to change in DMARD and/or anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for biomarker studies and processed according to the international committee of Outcome Measures in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A urine sample (20 ml) will also be taken and processed as for serum. Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months). Patients will be followed for 2 years.

NCT ID: NCT01476228 Not yet recruiting - Depression Clinical Trials

EEG Objectification in Neuropsychiatry

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

The main objective of the study is to evaluate the use of EEG in the management and follow-up of neuropsychiatric disorders. Secondary objectives are therefore better understanding of the pathological activations in neural network during neuropsychiatric disorders, their clinical evolution and response to therapies.

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: NCT01474447 Recruiting - Low Back Pain (LBP) Clinical Trials

The Effect of Grinberg Method (GM) Intervention on Low-back Pain (LBP) and Improving the Quality of Life

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

The purpose of the research is to check the efficiency of practicing the tools of the Grinberg method (GM) in reducing Low-back Pain (LBP), reducing limitations in movement as a result of the pain, and improving the general quality of life. The hypothesis suggests that by learning to perceive pain differently, the level of pain will reduce and general well-being improved.

NCT ID: NCT01474122 Terminated - Systemic Sclerosis Clinical Trials

Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients

DUAL-2
Start date: December 2011
Phase: Phase 3
Study type: Interventional

The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration. All patients completing Period 1 will continue on their original randomized treatment into Period 2, until the last randomized patient has completed Period 1. Patients will be randomized in a 1:1:1 ratio (macitentan 3mg: macitentan 10mg: placebo). The primary objective is to demonstrate the effect of macitentan on the reduction of the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcers (DU). Other objectives include: - the evaluation of the efficacy of macitentan on hand functionality and DU burden at Week 16 in SSc patients with ongoing DU disease. - the evaluation of the safety and tolerability of macitentan in these patients. - the evaluation of the efficacy of macitentan on time to first DU complication during the entire treatment period.

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: NCT01473459 Not yet recruiting - Infertility Clinical Trials

Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients

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

The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.

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: NCT01472887 Completed - Clinical trials for Diffuse Large B-cell Lymphoma

SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients

STARLYTE
Start date: January 2012
Phase: Phase 2
Study type: Interventional

Primary Objective: Participants achieving an Objective Response Rate Secondary Objective: - Progression Free Survival - Overall Survival - Response Duration - Safety