Articles Related to Clinical trial

Gestational diabetes mellitus (GDM) is associated with an increased maternal and fetal risk of complications. Other than lifestyle modifications and diet, little prevention can be done towards this maternal complication. Through a preclinical approach and a retrospective clinical trial, we investigated the effects of maternal supplementation with a nutraceutical composition based on resveratrol (RSV) and alpha-lipoic acid (ALA) on insulin resistance and GDM status

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We propose a novel strategy to predict unknown data from a smaller sample size by using compressive sensing which is one of the information technology used in artificial intelligence. In this study, we applied the compressive sensing to an empirical sample of clinical trials comprising of two groups. Each group required the time data of 25 patients but the data of 12 more patients had to be acquired to satisfy alpha and beta errors.

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Gherkin, a pure botanical extract from cucumber is a phytonutrient rich vegetable which may have been shown to have anti-inflammatory and pain relieving properties. The purpose of this randomized double-blind placebo study was to determine the effects of Gherkin (Cuvitus™, Actido®)on exercise performance, markers of inflammation and acute muscle soreness in healthy males.

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An observational study was conducted on the efficacy of Neramexane in a small cohort of Hispanic subjects who were diagnosed with moderate to severe subjective tinnitus. Patients were screened using the inclusion and exclusion criteria as outlined by the study sponsor. The study protocol involved daily intake of Neramexane 50 mg/day (for weigh<90 kg) or 75 mg/day (weight>90 kg) for 29 weeks with primary efficacy assessed through audiogram study and 3 electronic self-reporting questionnaires: Tinnitus Handicap Inventory-12 (TBF/THI-12) Scale, Tinnitus Rating Scale (TRS) and Hospital Anxiety and Depression Scale (HADS).

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This study tested for the cardiac effects of Oprelvekin, recombinant human interleukin-11, a thrombopoietic growth factor, in patients afflicted with chemotherapy-induced thrombocytopenia (platelet count<50,000 cells/ul). Chart-reviews of patients fulfilling the inclusion criteria of: 18-75 yrs of age, non-myeloid malignancy, with adequate hematologic, hepatic and renal parameters and normal electrocardiograms that were enrolled in this phase 2 trial were analyzed. Patients of child-bearing potential agreed to be on a reliable form of birth control for the duration of the study. Results on 4 patients suggest that Oprelvekin does not cause atrial nor ventricular arrhythmia, a rare severe cardiac side effect, in treating patients with chemotherapy-induced thrombocytopenia.

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Lumbosacral radicular pain (LRP) is a common symptom, its annual prevalence in the general population is reported to be from 9.9% to 25% and it is characterized by a shooting, radiating pain to one or more dermatomes, which is often caused by irritation of the corresponding nerve root. The initial treatment should be conservative with oral medications, exercise, and physiotherapy. When conservative treatments fail, epidural steroid injections and other interventional treatments should be considered. Surgical interventions are indicated when all other treatments have failed.

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Dentin hypersensitivity (DH) is generally described as “a brief, sharp, and acute pain emanating from exposed dentin in response to thermal, tactile, osmotic, or chemical stimuli, as well as exposure to air that cannot be attributed to any dental anomaly or pathology”.

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Opinion is divided as to the changes in ventricular function brought about by exercise, with few studies on water-based exercise programmes for heart-failure patients. This study investigates whether following a partial water-based exercise programme could lead to an earlier improvement in ventricular function in heart-failure patients compared with a land-based exercise programme.

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Seventeen alpha hydroxyprogesterone caproate (17-OHPC) is the only FDA-approved drug labeled for prevention of preterm delivery. This drug is also available as a compounded product from licensed compounding pharmacies. This article reviews the FDA approval history and pharmacy compounding quality control data of 17-OHPC, as well as briefly discusses possible future pharmaceutical development strategies for 17-OHPC.

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In this study, we focused on the effect of β-glucan supplementation of children with chronic respiratory problems. We measured the levels of cortisol, salivary IgE and cotinine in 56 children and evaluated the effect of 30 day supplementation with 100 mg/day oral dose of yeast-derived β-glucan. Our results showed strong decrease of cotinine and cortisol levels in saliva of β-glucan-supplemented children.

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Capsaicin, an active ingredient of Capsicum fruit, is currently undergoing “revival” in the clinical management of pain. However, the choice of its formulation is rather limited to the use of “old-fashioned” tinctures and recently the patches. In an attempt to improve the therapeutic outcome and develop its skin-friendly formulation, we prepared the vesicle-based drug delivery system with capsaicin.

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Mycophenolic Acid (MPA) is one of the most widely used immunosuppressive agents in kidney transplantation. This study was designed to compare the safety, tolerability and efficacy of two formulations of mycophenolic acid, Mycophenolate Mofetil (MMF) and Enteric-Coated Mycophenolate Sodium (EC-MPS), in renal transplant recipients.

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