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NCT ID: NCT03318042 Completed - Clinical trials for Genotype, Metabotype and Dietary Habits

Genotype, Metabotype and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.

PolyMicroBio
Start date: February 1, 2016
Phase: N/A
Study type: Interventional

The objective of this study is to investigate the possible association between 60 SNPs related to obesity, metabolism and cardiovascular disease with BMI, intestinal microbiota and adherence to the Mediterranean diet in a cohort of children and adolescents from the southeast of Spain.

NCT ID: NCT03317821 Completed - Clinical trials for Dural Arteriovenous Fistula

PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

Start date: September 18, 2017
Phase:
Study type: Observational [Patient Registry]

The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.

NCT ID: NCT03316885 Completed - Cataract Clinical Trials

Post-Market Clinical Investigation of the Clareon® IOL

Start date: March 14, 2018
Phase: N/A
Study type: Interventional

The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.

NCT ID: NCT03315104 Completed - Influenza A H1N1 Clinical Trials

Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A

Start date: November 17, 2017
Phase: Phase 2
Study type: Interventional

Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with the flu. The study is looking to see if antibodies collected from people who have recovered from the seasonal flu or who have had the seasonal flu shot can be used safely as a study drug to treat hospitalized patients with severe flu infections. Also, this study will help to find the right dose for this study drug for treatment of severe flu in hospitalized patients. Overall, this study will evaluate if the hospitalized patients receiving standard of care along with the study drug get better more quickly than those treated with standard of care and placebo. The study drug that contains antibodies against the flu is called anti-influenza immunoglobulin intravenous (FLU-IGIV).

NCT ID: NCT03314766 Completed - Cataract Clinical Trials

Evaluation of Long-Term Clinical Acceptability and Satisfaction With the IC-8 Intraocular Lens

Start date: October 20, 2017
Phase:
Study type: Observational

The purpose of this study is to evaluate the long-term clinical acceptability and overall satisfaction with the IC-8 IOL at least 12 months post-IOL implantation.

NCT ID: NCT03314753 Completed - Atrial Fibrillation Clinical Trials

FIRE AND ICE Re-Ablations (Retrospective Data Collection)

Re-Do
Start date: January 18, 2018
Phase:
Study type: Observational

Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.

NCT ID: NCT03313427 Completed - Preterm Infant Clinical Trials

Early Physical Therapy Intervention in Preterm Infants

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

The hypothesis of this study is that early physical therapy intervention, initiated during the NICU stay and up to 2 months corrected age, based on the family-centered model, could promote preterm infants motor development in short-term (2 months corrected age) and long-term (8 months corrected age). There is a high evidence level of different systematic reviews, which support the effectivity of early intervention with preterm infants. The principal aim of this randomized controlled trial is to evaluate the effectiveness of early physiotherapy intervention to promote motor development in preterm infants at 2 and 8 months corrected age. The secondary purpose is to study the motor development of those preterm infants who received early physical therapy intervention.

NCT ID: NCT03313180 Completed - Clinical trials for Lung Diseases, Interstitial

A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis

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

The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).

NCT ID: NCT03312907 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE

Start date: March 1, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 292 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks.

NCT ID: NCT03312751 Completed - Clinical trials for Primary Hemophagocytic Lymphohistiocytosis

Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis

Start date: February 6, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to expand the knowledge on the efficacy and safety of emapalumab (previously known as NI-0501) as a treatment for primary haemophagocytic lymphohistiocytosis (HLH) patients, including on long-term outcomes and quality of life assessments. Emapalumab can be administered as the first-line therapy to patients not previously treated with the current standard of care, or can be given to patients who have either failed or were unable to tolerate the available standard of care. Emapalumab is to be administered until the start of conditioning for hematopoietic stem cell transplantation (HSCT), with an anticipated duration ranging from a minimum of 4 weeks to approximately 12 weeks and not exceeding 6 months. After treatment completion, patients will continue in the study for long-term follow-up until 1 year after either HSCT or last emapalumab infusion (if HSCT is not performed).