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NCT ID: NCT02520544 Active, not recruiting - Clinical trials for Arthroplasty, Replacement, Hip

ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert

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

The aim of this register is to determine the Accolade/Accolade II stem and Trident/Tritanium cup survivorship over years.

NCT ID: NCT02516722 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

TReatment Of Pulmonary HYpertension 1 Study

TROPHY
Start date: February 2016
Phase: N/A
Study type: Interventional

The objective of this study is to assess the safety, performance and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation through subjective and objective change in clinical parameters and haemodynamic evaluation. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 5 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific medications.

NCT ID: NCT02516241 Active, not recruiting - Urothelial Cancer Clinical Trials

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

Start date: November 2, 2015
Phase: Phase 3
Study type: Interventional

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer

NCT ID: NCT02513394 Active, not recruiting - Breast Cancer Clinical Trials

PALbociclib CoLlaborative Adjuvant Study

PALLAS
Start date: August 2015
Phase: Phase 3
Study type: Interventional

This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early breast cancer (EBC). The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HR+/HER2- early breast cancer. Assessment of a variety of correlative analysis, including evaluation of the effect of palbociclib in genomically defined tumor subgroups, is planned.

NCT ID: NCT02511327 Active, not recruiting - Pertussis Clinical Trials

Pertussis Immunization During Pregnancy: Effect in Term and Preterm Infants

MAMA
Start date: January 2015
Phase:
Study type: Observational

Young infants are most vulnerable to severe disease and even death when infected with Bordetella Pertussis. The current vaccines and vaccination programs do not guarantee protection of neonates. During the last weeks of pregnancy, maternal IgG antibodies are transferred actively to the fetus. Administration of a pertussis containing vaccine during pregnancy offers protection through high titers of maternal antibodies transferred to the child. Since transplacental transport is immature, infants who are born prior to 37 weeks of gestation, might be vulnerable to pertussis infection even though maternal vaccination was administered, but specific data are lacking. The primary aim of this observational study is to measure whether vaccination during pregnancy offers protection to preterm born infants through higher titers of maternal antibodies, despite immature transplacental transport. Four cohorts of mother-infant pairs will be recruited: term versus preterm born infants, born from either vaccinated women or not vaccinated women. These mother-infant pairs are recruited according to the vaccination status of the mother and to the gestational age at delivery. Pertussis specific antibody titers (anti-Pertussis Toxin, anti-Filamentous haemagglutinin, anti-Pertactin titers) will be monitored in blood samples of the mothers at delivery to measure the possible influence of both gestational age and maternal vaccination status. In order to measure the decline of maternal antibodies in the first weeks of life, blood will be taken from cords as well as from infants at 8 weeks of age, before the first infant pertussis vaccine is administered. Pertussis antibodies to the same antigens will be measured in all infants after a primary series of acellular pertussis vaccines administered at 8,12 and 16 weeks of age and before and after a booster dose in the second year of life. In addition, cellular mediated immune responses will be evaluated in a subgroup of infants before and after a primary series of infants vaccines. A last goal is to measure whether vaccination during pregnancy could offer additional maternal antibodies through breast milk. Again a comparison is made between preterm and term born infants, born from either vaccinated or unvaccinated women. The amount of lactoferrin and pertussis toxin specific IgA in breast milk samples will be measured in samples taken at birth (colostrum), and at several time points afterwards as long as breastfeeding is continued.

NCT ID: NCT02511106 Active, not recruiting - Clinical trials for Stage IB-IIIA Non-small Cell Lung Carcinoma

AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.

ADAURA
Start date: October 21, 2015
Phase: Phase 3
Study type: Interventional

To assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy

NCT ID: NCT02510560 Active, not recruiting - Clinical trials for Premature Birth of Newborn

Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

Start date: December 2016
Phase: Phase 3
Study type: Interventional

The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.

NCT ID: NCT02508714 Active, not recruiting - Clinical trials for Coronary Artery Disease

Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents

BIONYX
Start date: October 7, 2016
Phase: N/A
Study type: Interventional

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.

NCT ID: NCT02503423 Active, not recruiting - Lymphoma Clinical Trials

Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

Start date: July 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available.

NCT ID: NCT02500381 Active, not recruiting - Clinical trials for Duchenne Muscular Dystrophy

Study of SRP-4045 (Casimersen) and SRP-4053 (Golodirsen) in Participants With Duchenne Muscular Dystrophy (DMD)

ESSENCE
Start date: September 28, 2016
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of SRP-4045 (casimersen) and SRP-4053 (golodirsen) compared to placebo in participants with DMD with out-of-frame deletion mutations amenable to skipping exon 45 and exon 53, respectively.