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NCT ID: NCT03240523 Recruiting - Uterine Fibroids Clinical Trials

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Compare to Ulipristal

ASTEROID 5
Start date: July 31, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of vilaprisan in subjects with uterine fibroids compared to ulipristal The secondary objective of this study is to evaluate the efficacy and safety of different treatment regimens of vilaprisan in subjects with uterine fibroids

NCT ID: NCT03235050 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes

Start date: August 2, 2017
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382.

NCT ID: NCT03214380 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes

PRONTO-T2D
Start date: July 14, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).

NCT ID: NCT03214367 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

A Study of LY900014 in Participants With Type 1 Diabetes

PRONTO-T1D
Start date: July 17, 2017
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).

NCT ID: NCT03207425 Recruiting - NASH Clinical Trials

A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers

Start date: June 14, 2017
Phase: Phase 1
Study type: Interventional

This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects.

NCT ID: NCT03203096 Completed - Stress Physiology Clinical Trials

Magnesium Supplementation in Stress Conditions

Start date: January 15, 2017
Phase: N/A
Study type: Interventional

This study aims to determine how a 6-week magnesium supplementation with 400 mg magnesium from magnesium citrate/magnesium oxide affects stress parameters in students in exam preparation.

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: NCT03105687 Recruiting - Hypertension Clinical Trials

Effectiveness of SMS Reminders of Blood Pressure-lowering Drugs Intake

SPPA
Start date: June 16, 2017
Phase: N/A
Study type: Interventional

By conducting the SPPA trial we try to find out, whether personalized Short Message Service (SMS) reminders of blood pressure-lowering medication can effectively increase patients' adherence to blood pressure-lowering medication. Additionally, we also evaluate their effect on patients' systolic blood pressure control.

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.