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NCT ID: NCT03131687 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study of LY3298176 in Participants With Type 2 Diabetes Mellitus

Start date: May 24, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of the study drug LY3298176 in participants with type 2 diabetes mellitus.

NCT ID: NCT03125902 Recruiting - Clinical trials for Triple-Negative Breast Cancer

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

IMpassion131
Start date: August 3, 2017
Phase: Phase 3
Study type: Interventional

This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 45 months).

NCT ID: NCT03105232 Recruiting - Opioid Use Clinical Trials

Opioid-Redox Study

ORS
Start date: May 1, 2017
Phase: N/A
Study type: Observational

Side effects of opioids can from practical view be divided into short-term and long-term. Nervous system disorders are manifested by psychological status changes of the patient and may cause confusion, mental and somatic dependency, dizziness and so on. Influencing the vegetative and cardiovascular system hypotension can occur what is manifestation of vasodilation and decreased myocardial inotropic activity. Another clinical sign is bradycardia and is characterized by general weakness, sweating, collapse can develop. Effects of opioids may cause respiratory depression, bronchospasm and bronchoconstriction. Side effects on the gastrointestinal tract are nausea, vomiting, constipation and less frequently dry mouth. The constipation does not develop tolerance and has to be avoided (dietary modification, laxatives prevention) respectively during long-term opioid treatment obstipation should be affected by blocking peripheral opioid receptors in the gastrointestinal tract by application of an opioid antagonist methylnaltrexone, which does not cross the blood brain barrier, or using naloxone, which is metabolized by "first-pass" metabolism in the liver for example combined preparation containing oxycodone and naloxone (Kulichová, 2012). Known side effects on parenchymatous organ especially on liver is restricted biliary excretion caused by spasm of the biliary tract. Skin manifestations caused by the effects of opioids are urticaria, dermatitis, and pruritus. Renal and urinary disorders may develop as urinary retention and ureteral spasm. Rarely can occur disorders of the immune system, which through the development of hypersensitivity may lead to the development of anaphylactic shock (Kulichová, 2012). Opioids have a negative effect and the endocrine system. Various studies have demonstrated the influence of opioids on regulatory mechanisms. Fundamental changes occur in hypothalamic-pituitary complex, which directs the activities of all the endocrine system. Secretion of hormones of the pituitary gland regulates the nervous system through the hypothalamus, which is the coordination center of autonomic function. The pituitary gland has coordinating function in relation to other endocrine glands, and by production of their hormones affects the peripheral endocrine organs and the targeting tissues (Kulichová, 2012), (Colameco, 2009). Opioids decrease the secretion of gonadotropin-stimulating hormone, resulting in reduced levels of luteinizing hormone. The result of these changes is reduced secretion of testosterone and estradiol what results in symptoms of hypogonadism. Chronic administration of exogenous opioids decreases the levels of adrenocorticotropic hormone and cortisol, as well as their circadian rhythms. The result is a reduction in the response to stress. Effect on prolactin is not entirely clear. Opioids can stimulate the hypothalamus through the thyroid stimulating hormone, which may cause prolonged and increased response to opioids in patients with hypothyroidism. Chronic use of opioids is associated with weight gain, hyperglycemia and diabetes can worsen (Kulichová, 2012). It may be related to central effects through the sympathetic nervous system and impaired insulin secretion. New laboratory measurements show the development of oxidative stress in patients receiving morphine and related drugs (Merdin, 2016). The consequences of these biochemical changes further negatively affect the clinical outcome of the patients. They may become predisposed to excessive progression of previously latent diseases whose manifestations in patients previously were not apparent and there is emergence of new diseases. The present data are essential to create a clinical prospective observational studies to clarify this issue and its conclusions would be essential for new therapeutic options for adjuvant therapy in patients suffering from chronic pain.

NCT ID: NCT03085810 Recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)

Start date: March 27, 2017
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks.

NCT ID: NCT03071068 Recruiting - Clinical trials for Diabetic Retinopathy

A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)

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

This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME).

NCT ID: NCT03066830 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

Start date: February 24, 2017
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superiority of sotagliflozin 400 mg versus placebo on Hemoglobin A1c (HbA1c) reduction at Week 26 in patients with type 2 diabetes (T2D) who have inadequate glycemic control with a sulfonylurea alone or in combination with metformin. Secondary Objectives: - To compare sotagliflozin 400 mg versus placebo based on: - Change from baseline in fasting plasma glucose (FPG). - Change from baseline in systolic blood pressure (SBP) for patients with baseline SBP ≥130 mm Hg. - Change from baseline in SBP for all patients. - Change from baseline in body weight. - Proportion of patients with HbA1c <6.5% and <7.0%. - To evaluate the safety of sotagliflozin 400 mg versus placebo throughout the 79-week trial.

NCT ID: NCT03062644 Recruiting - Acute Pain Clinical Trials

Efficacy and Safety in a Randomised Acute Pain Study of MR308: STARDOM2.

STARDOM2
Start date: April 5, 2017
Phase: Phase 3
Study type: Interventional

The MR308-3502 study is a multicenter double-blind, randomised, placebo- and active comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308 with acute pain after TAH or STAH (total or subtotal abdominal hysterectomy).

NCT ID: NCT03056612 Recruiting - Clinical trials for Liver Cirrhosis With Acute Decompensation

Predicting Acute-on-Chronic Liver Failure in Cirrhosis (PREDICT) Study

PREDICT
Start date: March 2, 2017
Phase: N/A
Study type: Observational

The aim of this study is to assess prospectively the critical period prior to the development of Acute-on-Chronic Liver Failure (ACLF) (1), to uncover mechanistic and pathophysiological processes associated with the development and clinical course of ACLF (2) and to identify the precipitating events of ACLF (3).

NCT ID: NCT03055559 Recruiting - Iron Deficiency Clinical Trials

Trial Protocol GlobiFer - Oral Iron Repletion

TPG
Start date: June 2016
Phase: N/A
Study type: Interventional

The haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with GlobiFer Forte.

NCT ID: NCT03052595 Recruiting - Multiple Sclerosis Clinical Trials

Multiple Sclerosis: The Role of Mitochondrial Dysfunction in IR Resistance

MS-MIDY
Start date: February 1, 2017
Phase: N/A
Study type: Observational

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS) and is one of the most common neurological diseases, often leading to disability of the patients. The MS pathogenesis includes vascular and inflammatory components, however recently also the role of mitochondrial dysfunction being a hot topic in neurodegeneration.