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NCT ID: NCT02331810 Withdrawn - Clinical trials for Systemic Lupus Erythematosus

Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients

Start date: April 2016
Phase: Phase 1
Study type: Interventional

Primary Objective: Assess in systemic lupus erythematosus (SLE) patients the effect of SAR113244 on B-cell subsets compared to placebo. Secondary Objectives: Assess in male and female lupus patients after SC single dose of SAR113244 the tolerability and safety of SAR113244. Assess in male and female lupus patients: - The pharmacokinetics of SAR113244. - The pharmacodynamics of SAR113244 for the following disease parameters: - Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index (if applicable), Lupus-quality of life and Functional Assessment of Chronic Illness Therapy-Fatigue, anti-double stranded deoxyribonucleic acid antibody and anti-nuclear antibody levels and plasma complement levels (C3, C4), erythrocyte sedimentation rate and C-reactive protein. - Peripheral blood B and T cell subsets.

NCT ID: NCT02351440 Withdrawn - Laparoscopy Clinical Trials

Effect of Preoperative Duloxetine on Quality of Recovery After Outpatient Laparoscopic Surgery

Start date: April 2016
Phase: Phase 4
Study type: Interventional

The objective of this study is to determine the effect of preoperative duloxetine on postoperative quality of recovery after ambulatory surgery, specifically laparoscopic gynecological surgery.

NCT ID: NCT02385825 Withdrawn - Ricin Poisoning Clinical Trials

IM Recombinant Ricin Toxin Vaccine (RVEc) — 3-Dose Primary Series With Boost

Start date: April 2016
Phase: Phase 1
Study type: Interventional

This study seeks to determine the safety and immunogenicity of a series of 3 primary vaccinations and a booster vaccination of Recombinant ricin toxin A-chain 1-33/44-198 (rRTA 1-33/44-198) vaccine (RVEc) at 10, 50, or 75 μg IM. This study is evaluating if RVEc will display an acceptable safety profile as determined by adverse event (AE) data and if RVEc will elicit anti-ricin antibody titers and ricin toxin-neutralizing antibodies in vaccine recipients.

NCT ID: NCT02388971 Withdrawn - Clinical trials for Atherosclerotic Cardiovascular Disease

Proof of Mechanism Study of MLN1202 on Atherosclerotic Inflammation in Participants With Stable Atherosclerotic Cardiovascular Disease

Start date: April 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of MLN1202 on arterial inflammation in participants with stable atherosclerotic cardiovascular disease (CVD) who are receiving standard-of-care (SOC) therapy.

NCT ID: NCT02425072 Withdrawn - Clinical trials for Small Cell Lung Cancer

NovoTTF-100A Therapy for Refractory CNS Involved Small Cell Lung Cancer

Start date: April 2016
Phase: Phase 2
Study type: Interventional

The hypothesis of this study is that the addition of NovoTTF-100A System treatment to salvage chemotherapy will significantly increase time to treatment failure in the brain of small cell lung cancer patients.

NCT ID: NCT02454426 Withdrawn - Clinical trials for Coronary Artery Disease

Vortioxetine in Patients With Major Depressive Disorder and Coronary Artery Disease

Start date: April 2016
Phase: Phase 0
Study type: Interventional

This is a preliminary, open-label, clinical trial designed to assess the efficacy, safety, and tolerability of vortioxetine for the treatment of major depressive disorder in patients with coronary artery disease. In addition, the study will assess the effects of vortioxetine on heart rate variability in these patients.

NCT ID: NCT02539420 Withdrawn - Status Asthmaticus Clinical Trials

A Prospective Trial of BiPAP Administration vs. Non-positive Pressure Therapy for Pediatric Status Asthmaticus

Start date: April 2016
Phase: N/A
Study type: Interventional

Though BiPAP is an increasingly common tool used by pediatric critical care physicians and there is promising data suggesting a role for BiPAP in the management of status asthmaticus, more information is needed to more definitively clarify the extent of its benefit, as well as when during an asthma exacerbation and in whom it is the most beneficial. In this study, which is among the first randomized studies of BiPAP use for status asthmaticus in the pediatric population, the investigators hope to better elucidate these issues to help guide clinicians' future management decisions.

NCT ID: NCT02558361 Withdrawn - Psoriatic Arthritis Clinical Trials

Treatment With Apremilast in Patients With Psoriatic Arthritis

Start date: April 2016
Phase: Phase 4
Study type: Interventional

Apremilast (Otezla®) is a Federal Drug Administration (FDA)-approved treatment for psoriatic arthritis and psoriasis. Although there are a lot of data demonstrating how apremilast works in the laboratory, there are very few demonstrating how it works in the actual target organ, i.e. the skin or synovial (joint) tissue in patients with psoriasis and psoriatic arthritis. Laboratory data has demonstrated that apremilast decreases inflammatory proteins and increases anti-inflammatory proteins. However, almost all of these data/studies have been performed on the blood of patients with psoriasis and psoriatic arthritis, not the skin or synovial (joint) tissue. These studies that have been performed on the blood of patients with this condition may, or may not, reflect the true response to therapy in the synovial (joint) tissue and/or skin.

NCT ID: NCT02568826 Withdrawn - Low Back Pain Clinical Trials

Tolerability, Safety and Activity of a Muscle Relaxant Molecule IDN5243 in Patients With Low Back Pain

IDN5243inLBP
Start date: April 2016
Phase: Phase 2
Study type: Interventional

This is a prospective cohort study, open-label, uncontrolled proof of concept trial. The trial objective is to evaluate the analgesic tolerability, safety and activity of IDN 5243 (3-glycosyl-3-O-demethylthiocolchicine derivative)administered intramuscularly at 4 mg b.i.d. for 5 days in the morning (8.00-10.00 AM) and in the evening (6.00-8.00 PM) in subjects with Low Back Pain (LBP).

NCT ID: NCT02578459 Withdrawn - Pain Management Clinical Trials

A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain

Start date: April 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain.