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NCT ID: NCT02624869 Completed - Clinical trials for Familial Hypercholesterolemia

Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)

HAUSER-OLE
Start date: September 10, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.

NCT ID: NCT02614794 Completed - Clinical trials for HER2 Positive Breast Cancer

A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer

HER2CLIMB
Start date: January 28, 2016
Phase: Phase 2
Study type: Interventional

This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo. The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.

NCT ID: NCT02613715 Completed - Healthy Clinical Trials

Bioavailability of Blackberry Juice Anthocyanins

Start date: March 2015
Phase: Phase 1
Study type: Interventional

The main aim of this study is to evaluate the bioavailability of blackberry juice anthocyanins, with or without ethanol, in normal weight and overweight/obese adults.

NCT ID: NCT02608138 Completed - Clinical trials for Urinary Iodine Status in School Aged Children

Iodine Status in Portuguese Children and the Role of Salt Fortification in School Canteens

IoGeneration
Start date: April 2015
Phase: N/A
Study type: Observational

It is well known that insufficient iodine intakes impairs the production of thyroid hormones, essential for cognitive development and healthy growth. Although the World Health Organization (WHO) promotes public health measures for an adequate iodine consumption, it is estimated that one in three school age children remain iodine deficient worldwide. Whereas there is no mandatory iodisation programs in Portugal, young infants are among the most vulnerable to iodine deficiency due to their special requirements. Therefore, the present study aims to evaluate iodine status in school age Portuguese children (6-12y), compare iodine status in children, cognitive outcomes and thyroid health and monitor the use of iodised salt in school canteens exploring potential implications in children's iodine status.

NCT ID: NCT02607761 Completed - Educational Video Clinical Trials

Fertility Awareness in University Students

FAST
Start date: October 2014
Phase: N/A
Study type: Interventional

Recent evidence showed that undergraduate students have inappropriate knowledge about reproductive health and infertility. The investigators' aim was to assess the effectiveness of a brief intervention (video) in increasing the knowledge regarding fertility issues, fertility risk factors and infertility definition.

NCT ID: NCT02607618 Completed - Clinical trials for Skin Structures and Soft Tissue Infections

Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-2

REVIVE-2
Start date: November 2015
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

NCT ID: NCT02604342 Completed - Clinical trials for Non-small Cell Lung Cancer

Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib

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

This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC).

NCT ID: NCT02603432 Completed - Urothelial Cancer Clinical Trials

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

Start date: April 25, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.

NCT ID: NCT02597933 Completed - Clinical trials for Scleroderma, Systemic

A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

Start date: November 12, 2015
Phase: Phase 3
Study type: Interventional

Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

NCT ID: NCT02597920 Completed - Atrial Fibrillation Clinical Trials

Patient Convenience Study

Start date: November 11, 2015
Phase:
Study type: Observational

The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).