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NCT ID: NCT02244606 Completed - Mycoses Clinical Trials

Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

Start date: September 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.

NCT ID: NCT02231047 Not yet recruiting - Pneumonia Clinical Trials

64N Nutraceutical for the Prevention of Childhood Diarrhea and Pneumonia in Low Resource Settings

Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the occurrence of childhood diarrheal disease and pneumonia in subjects under the age of 5 years in low resource settings who have received prophylactic 64N nutraceutical (64N)as a neonate as compared with neonates who have not received prophylactic 64N.

NCT ID: NCT02226120 Completed - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction

Start date: October 16, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.

NCT ID: NCT02222493 Completed - Clinical trials for Rheumatoid Arthritis

A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

Start date: August 26, 2014
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.

NCT ID: NCT02208609 Completed - Clinical trials for Nutritional Deficiency

Zinc Bioavailability From Amaranth-enriched Maize Tortillas

Start date: January 2012
Phase: N/A
Study type: Interventional

Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common. Supplementation of Zn to children during diarrhea episodes has been shown to diminish duration and severity of illness. Poor Zn absorption due to high fiber and phytate in this diet might play a role in these processes. Supplementation of this micronutrient in the diet might be beneficial. The investigators will compare absorption of Zn from white maize tortillas enriched with 20% amaranth to traditional white corn tortillas in preschool children in Guatemala.

NCT ID: NCT02203890 Completed - Healthy Clinical Trials

Normative State and Variation in Growth, Hematology, Hydration, Oxidation, Infection, Inflammation, Guatemalan Children

Start date: June 2012
Phase: N/A
Study type: Observational

This study will provide the researchers with an opportunity for the investigation of the biomarkers and different human biology component variable interactions in children; information that can generate new correlations between markers not known at the moment. Regarding their analysis, variation could have multiple connotations. A categorical that refers to a specific state, established with a diagnostic standard. And a numerical, referring to a range or the absolute value limits in a continuous spectrum; this research will allow us to express variability in the distance amplitude of the obtained values level, as well as classifications or categories previously established in the possible cases. OBJECTIVES PRINCIPAL OBJECTIVE To estimate the inter and intra-individual variety in a selected series or biological variables determinant of growth, body composition, infection, oxidation, inflammation and hydration, in preschool children sharing the same institutional-based diet. SPECIFIC OBJECTIVES - To determine the inter and intra-individual variation of growth in preschool children, with a similar diet, who attend Secretariat of Beneficial Works of the First Lady system daycare centers and to compare between semi-urban and rural. - To describe the inter-individual variation of the red blood cells circulating mass in preschool children, with a similar diet, who attend day care centers and to compare between semi-urban and rural. - To determine the inter-individual variation of systemic and intraintestinal oxidation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural. - To describe the inter-individual variation of systemic and intraintestinal inflammation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural. - To determine the inter and/or intra-individual variation of urinary tract infection and gastrointestinal parasite infestation in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural. - To describe the inter and intra-individual variation of the hydration status in preschool children, with a similar diet, who attend daycare centers and to compare between semi-urban and rural. - To explore intra-individual associations in variables of the same research component or different component variables.

NCT ID: NCT02161562 Completed - Clinical trials for Chronic Spontaneous Urticaria

OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients

OPTIMA
Start date: August 1, 2014
Phase: Phase 3
Study type: Interventional

This trial assessed the efficacy of optimized re-treatment therapy with omalizumab (150mg or 300mg) after relapse, in participants with Chronic Spontaneous Urticaria who were clinically well-controlled following their first course of treatment with omalizumab (150mg or 300mg). The study also assessed the benefit of uptitrating to 300mg dose in participants who were not well-controlled following their initial course of treatment with omalizumab 150mg, as well as the benefit of treatment extension of those patients who were not well-controlled following their initial course of treatment with omalizumab 300mg.

NCT ID: NCT02141672 Completed - Lupus Nephritis Clinical Trials

AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

AURA-LV
Start date: June 2014
Phase: Phase 2
Study type: Interventional

To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete remission after 24 weeks of therapy in subjects with active lupus nephritis.

NCT ID: NCT02075840 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

ALEX
Start date: August 19, 2014
Phase: Phase 3
Study type: Interventional

This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.

NCT ID: NCT02065791 Completed - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy

CREDENCE
Start date: February 17, 2014
Phase: Phase 3
Study type: Interventional

The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).