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NCT ID: NCT01441739 Recruiting - Clinical trials for Necrotizing Enterocolitis

Intestinal Failure in Necrotising Enterocolitis

Start date: September 2004
Phase: N/A
Study type: Observational

Necrotizing enterocolitis (NEC) is a severe gastrointestinal disorder with high morbidity and mortality (20-40%), affecting predominantly premature neonates. NEC continues to present a diagnostic challenge to clinicians. The initial clinical manifestations of NEC are non-specific and indistinguishable from other gastrointestinal disorders and sepsis. The first goal of this study is to find and evaluate tests to diagnose NEC at an early stage. For the development of new diagnostic markers, the investigators require knowledge of pathophysiological processes that underlie NEC, which still remain unclear. Therefore, the second goal of this study is to elucidate the etiology of NEC. Furthermore, understanding of the pathophysiology of NEC can offer the possibility to develop new therapeutical treatments.

NCT ID: NCT01441583 Completed - Heart Failure Clinical Trials

Ingenio Device Algorithm Study

IVORY
Start date: October 2011
Phase: N/A
Study type: Interventional

The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.

NCT ID: NCT01441466 Completed - Bronchiolitis Clinical Trials

Cohort Isolation and Cross-infection in Bronchiolitis

Start date: November 2011
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the effect of cohort isolation of RS(respiratory syncytial virus)-positive bronchiolitis versus RS-negative bronchiolitis on prevention of co-infection and clinical disease severity. Furthermore the investigators want to elucidate general epidemiological data on bronchiolitis concerning viral causes and the associated clinical severity. The investigators want to conduct a prospective cohort study, comparing incidence of co-infection and clinical severity, in two cohort: one with isolation of RS positive bronchiolitis as a separate cohort within bronchiolitis and one without isolation (all children with RS-negative bronchiolitis are nursed together independent of viral agent)

NCT ID: NCT01440946 Completed - Hemophilia B Clinical Trials

Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B

Kids B-LONG
Start date: June 2012
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFIXFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes

NCT ID: NCT01440374 Active, not recruiting - Thrombocytopaenia Clinical Trials

A Three-part Study of Eltrombopag in Thrombocytopenic Subjects With Myelodysplastic Syndromes or Acute Myeloid Leukemia

ASPIRE
Start date: September 2011
Phase: Phase 2
Study type: Interventional

This is a worldwide, three-part (Part 1: open-label, Part 2: randomized, double-blind, Part 3: extension), multi-center study to evaluate the effect of eltrombopag in subjects with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) who have thrombocytopenia due to bone marrow insufficiency from their underlying disease or prior chemotherapy. This objective will be assessed by a composite primary endpoint that consists of the following: the proportion of ≥Grade 3 hemorrhagic adverse events, or platelet counts <10 Gi/L, or platelet transfusions. Patients with MDS or AML and Grade 4 thrombocytopenia due to bone marrow insufficiency from their underlying disease or prior chemotherapy will be enrolled in the study. No low or intermediate-1 risk MDS subjects will be enrolled in the study. Subjects must have had at least one of the following during the 4 weeks prior to enrolment: platelet count <10 Gi/L, platelet transfusion, or symptomatic hemorrhagic event. Supportive standard of care (SOC), including hydroxyurea, will be allowed as indicated by local practice throughout the study. The study will have 3 sequential parts. Subjects who are enrolled in Part 1 (open-label) cannot be enrolled in Part 2 of the study (randomized, double-blind); however, subjects who complete the treatment period for Part 1 or Part 2 (8 and 12 weeks, respectively) will continue in Part 3 (extension) if the investigator determines that the subject is receiving clinical benefit on treatment.

NCT ID: NCT01440257 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria

Start date: September 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to study the safety and efficacy of the medication in this patient population.

NCT ID: NCT01439880 Completed - Clinical trials for Hypercholesterolemia

Open Label Study of Long Term Evaluation Against LDL-C Trial

OSLER
Start date: October 7, 2011
Phase: Phase 2
Study type: Interventional

The primary clinical hypothesis is that long-term exposure of evolocumab (AMG 145) will be safe and well tolerated in adults with hypercholesterolemia.

NCT ID: NCT01439867 Terminated - Clinical trials for Chronic Kidney Disease

Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism

Start date: June 22, 2012
Phase: Phase 2
Study type: Interventional

The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).

NCT ID: NCT01439490 Completed - Clinical trials for Epithelial Ovarian Cancer

FES-PET to Determine ER-expression in Epithelial Ovarian Cancer

Start date: August 2011
Phase: Phase 2
Study type: Interventional

Estrogens are implicated in the development of ovarian cancer and estrogen receptors (ER) alpha and beta are present in 20-100% of ovarian cancer patients. For this reason, antihormonal therapy with anti-estrogens or ER-antagonists is potentially an attractive treatment option. However, only a small proportion of patients (5-19%) will respond to antihormonal therapy. ER-expression in ER-positive breast cancer can be assessed by positron emission tomography (PET) with [18F]fluoroestradiol (FES). In this study the investigators will evaluate whether FES-PET can be used to visualize and quantify ER-expression in ovarian cancer. If these results are positive, this would warrant further exploration of FES-PET imaging in ovarian cancer.

NCT ID: NCT01439308 Completed - Rhinitis Clinical Trials

Intranasal SB-705498 in Non-allergic Rhinitis Patients

Start date: December 2009
Phase: Phase 2
Study type: Interventional

This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge