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NCT ID: NCT03377218 Recruiting - Pregnancy Clinical Trials

Potential Preventive Effect of Selenium on Iodine-induced Thyroid Autoimmunity During Pregnancy

Start date: January 5, 2018
Phase: N/A
Study type: Interventional

In 1994, the WHO and UNICEF Joint Committee on Health Policy recommended Universal Salt Iodization as a safe, cost-effective and sustainable strategy to ensure sufficient intake of iodine by all individuals. However, it is still absent in Latvia. A recent countrywide study in 2013 shows iodine deficiency among pregnant women in Latvia: 81 % of pregnant women had UIC levels below the WHO recommended range of 150-250 mcg/g Cr. Because mild to moderate iodine deficiency during pregnancy can adversely affect fetal brain development, WHO-UNICEF and ICCIDD advise an increase in the recommended daily dosage of iodine to 250 mcg/day for pregnant women and breastfeeding women and 150 mcg/day for women in the preconception period. Data from a survey of the Latvian population indicate that approximately 100 mcg of iodine per day is consumed through foods and iodized salt. To meet the increased iodine requirement in pregnancy, pregnant women should take a supplement containing 150 mcg of iodine daily from the earliest time possible. A sudden increase in iodine intake in an iodine-deficient population may increase thyroid autoimmunity. It is evident that thyroid disease has multiple adverse effects during pregnancy and in the developing fetus especially in women with elevated serum anti-thyroid antibody titers. Studies have considered supplementing with selenium to reduce the risk of auto-immune thyroiditis/post-partum autoimmune thyroid disease. Of the 11 trials of selenium supplementation in patients with autoimmune thyroiditis, 7 have shown benefit with treatment for 6 months or longer. Aim of study is to approve that 150 mcg of iodine daily improves iodine status in pregnant women and iodine 150 mcg in combination with selenium 100 mcg daily reduce risk of thyroid autoimmunity. Hypothesis of study is that 150 mcg iodine daily during pregnancy improves iodine status. Iodine in combination with selenium is less associated with thyroid autoimmunity. Study design: Pregnant women are randomized for either 150 mcg iodine intake daily or 150 mcg iodine combined with 100 mcg selenium daily. Interventional group is compared with controls without particular iodine supplementation. Participants are asked to complete a questionnaire on dietary habits concerning iodine. Thyroid function (thyroid-stimulating hormone, free thyroxine) and thyroperoxidase antibodies (TPO-Ab) and urinary iodine are measured during first, second and third trimester of pregnancy and week 8 after delivery in both, intervention and control group.

NCT ID: NCT03376321 Terminated - Influenza A Clinical Trials

A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection

Start date: January 3, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.

NCT ID: NCT03366545 Recruiting - Heart Failure Clinical Trials

Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

BIO|STREAM HF
Start date: May 14, 2018
Phase:
Study type: Observational [Patient Registry]

The registry is primarily designed to assess outcome, efficacy and residual safety aspects of CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the observation of the patient status should help to find possible predictors for HF events and to identify areas of improvement for CRT and for CRT device settings.

NCT ID: NCT03362190 Completed - Clinical trials for Wet Age-related Macular Degeneration

ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)

Start date: October 11, 2017
Phase: Phase 2
Study type: Interventional

To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)

NCT ID: NCT03358576 Completed - Clinical trials for Intra Abdominal Infections

Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)

Start date: September 18, 2018
Phase: Phase 3
Study type: Interventional

This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin-metronidazole for treatment of complicated intra-abdominal infections in adults.

NCT ID: NCT03357614 Completed - Clinical trials for Complicated Urinary Tract Infections

Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults

Start date: September 18, 2018
Phase: Phase 3
Study type: Interventional

This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.

NCT ID: NCT03351478 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin

SOTA-EMPA
Start date: November 27, 2017
Phase: Phase 3
Study type: Interventional

The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.

NCT ID: NCT03350542 Completed - Clinical trials for Coronary Artery Disease

A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)

EVOLVE48
Start date: April 12, 2018
Phase: Phase 3
Study type: Interventional

EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) > 34 mm and ≤ 44 mm in length (by visual estimate) in native coronary arteries ≥2.5 mm to ≤4.0 mm in diameter (by visual estimate).

NCT ID: NCT03345849 Completed - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

U-EXCEL
Start date: December 7, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).

NCT ID: NCT03345836 Completed - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Start date: November 29, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).