Theorem Clinical Research

Clinical Intelligence

GSK's FluLaval Quadrivalent effective in preventing pediatric seasonal flu

Friday, December 13, 2013 01:29 PM

A peer-reviewed study issued online by the New England Journal of Medicine has reported that GlaxoSmithKline's FluLaval Quadrivalent reduced flu cases among children ages three to eight by 55.4% overall and lowered the risk of developing moderate-to-serious flu illness by 73.1%. This was the first large-scale clinical trial conducted specifically to review the safety and effectiveness of vaccinating children with a four-strain flu vaccine. The randomized, controlled clinical trial included 5,220 children and was one of the pivotal studies leading to the recent approval of FluLaval Quadrivalent by the FDA.

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FDA approves first drug treatment for Peyronie’s disease

Friday, December 13, 2013 01:10 PM

The FDA has approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.

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Bruin Biometrics conducts trials to detect pressure ulcers with the SEM Scanner

Thursday, December 5, 2013 10:36 AM

Bruin Biometrics (BBI) has announced results from two IRB-approved clinical trials conducted with the SEM Scanner, a Class IIA medical device that is intended to detect localized tissue edema and pressure induced tissue damage which may lead to the formation of pressure ulcers.

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Lexicon completes phase II study of LX1033

Thursday, December 5, 2013 09:56 AM

Lexicon Pharmaceuticals has announced top-line results from an initial phase II study exploring the use of LX1033 in diarrhea-predominant irritable bowel syndrome (IBS-d). LX1033 is an investigational drug that inhibits serotonin synthesis in the gastrointestinal tract. Serotonin is a neurotransmitter that has been shown to play a role in the symptoms of irritable bowel syndrome.

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New research shows promise for possible HIV cure

Wednesday, December 4, 2013 02:33 PM

Researchers have used radioimmunotherapy (RIT) to destroy remaining human immunodeficiency virus (HIV)-infected cells in the blood samples of patients treated with antiretroviral therapy, offering the promise of a strategy for curing HIV infection. Results of the study were presented at the annual meeting of the Radiological Society of North America (RSNA).

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The CenterWatch Monthly, December 2013

Monday, December 2, 2013 08:01 AM
Summary not available

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Boston Scientific system receives CE Mark approval for Dystonia

Tuesday, November 26, 2013 11:38 AM

The Boston Scientific Vercise Deep Brain Stimulation (DBS) System has received CE Mark approval for the treatment of intractable primary and secondary dystonia, a neurological movement disorder characterized by involuntary muscle contractions.

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Boehringer Ingelheim planning two global trials of Pradaxa

Tuesday, November 26, 2013 10:34 AM

Boehringer Ingelheim Pharmaceuticals plans to initiate two new global clinical trials of PRADAXA. One of the new trials, RE-DUAL PCI (Randomized Evaluation of Dual Therapy with Dabigatran v. Triple Therapy Strategy with Warfarin in Patients with NVAF that have undergone PCI with Stenting), is designed to evaluate the efficacy and safety of PRADAXA in patients with non-valvular atrial fibrillation (NVAF) who have undergone percutaneous coronary intervention (PCI), also known as angioplasty, with stent placement. The second of the new trials, RE-SPECT ESUS(TM) (Randomized Evaluation in Secondary stroke Prevention Comparing the Thrombin inhibitor dabigatran etexilate v. ASA in Embolic Stroke of Undetermined Source), is designed to evaluate the efficacy and safety of PRADAXA as a secondary stroke prevention therapy in patients who have suffered an embolic stroke of undetermined source (ESUS). Embolic strokes occur when a blood clot forms somewhere in the body and travels through the bloodstream to the brain.

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Novocure initiates NovoTTF Therapy trial for brain metastases from NSCLC

Tuesday, November 26, 2013 09:29 AM

Novocure, a privately-held Jersey Isle oncology company, has enrolled the first patients in the EF-21 Study, a prospective randomized clinical study of NovoTTF Therapy for patients with brain metastases from non-small cell lung carcinoma (NSCLC) cancer. NovoTTF Therapy is an anti-mitotic treatment delivered continuously throughout the day by the NovoTTF-100A System.

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Reinforced safety profile of Boehringer Ingelheim’s Pradaxa released

Tuesday, November 19, 2013 01:37 PM

Boehringer Ingelheim Pharmaceuticals has announced results from a new, long-term, combined analysis of the pivotal phase III RE-LY trial and its extension safety study RELY-ABLE. The data showed that after a median follow up of 4.6 years, with some patients followed up to 6.7 years, rates of stroke/systemic embolism and major bleeding were consistent with rates in previously reported analyses of RE-LY, one of the largest stroke prevention clinical studies ever conducted in patients with non-valvular atrial fibrillation (NVAF).

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Reality of costs and impact rain on Sunshine Act
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