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NCT ID: NCT03566017 Not yet recruiting - Fabry Disease Clinical Trials

Extension Study of 1 mg/mL Pegunigalsidase Alfa in Patients With Fabry Disease

Start date: September 2018
Phase: Phase 3
Study type: Interventional

The objective of PB-102-F60 is to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry patients who have successfully completed studies PB-102-F20 or PB-102-F30.

NCT ID: NCT03558152 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Start date: June 15, 2018
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.

NCT ID: NCT03558074 Recruiting - Clinical trials for Wet Age-related Macular Degeneration

Evaluate the Therapeutic Effects and Safety of ALK4290 in Patients With Refractory Wet Age-Related Macular Degeneration

Start date: April 20, 2018
Phase: Phase 2
Study type: Interventional

This study will evaluate the therapeutic effects and safety of 800 mg ALK4290 administered daily over a 6-week dosing period in subjects with refractory wet age-related macular degeneration (wAMD).

NCT ID: NCT03558061 Recruiting - Clinical trials for Wet Age-related Macular Degeneration

Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration

Start date: April 4, 2018
Phase: Phase 2
Study type: Interventional

This study will evaluate the therapeutic effects and safety of 800 mg ALK4290 administered daily over a 6-week dosing period in newly diagnosed patients with wet age-related macular degeneration (wAMD).

NCT ID: NCT03556358 Recruiting - Breast Cancer Clinical Trials

Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer

Start date: June 30, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.

NCT ID: NCT03555383 Recruiting - Liver Transplant Clinical Trials

Individualized Multimodal Hemostasis Evaluation Pyramid (IMHOTEP)

Start date: August 1, 2017
Phase:
Study type: Observational

This study evaluates the hemostatic changes defined as hemostasis reserve capacity (HRC) in the first perioperative 48 hours of bloodless liver transplanted patients.

NCT ID: NCT03552679 Recruiting - Right Heart Failure Clinical Trials

Serial Multiparametric Evaluation of Right Ventricular Function After Left Ventricular Assist Device Implantation

EuroEchoVAD
Start date: June 2018
Phase:
Study type: Observational [Patient Registry]

The primary purpose of this study is to investigate the evolution of Right Ventricular (RV) function before and after left ventricular assist device (LVAD) implantation, using novel echocardiographic quantification of RV size and function in combination with comprehensive hemodynamic, laboratory and clinical parameters. The findings of the study will enhance prediction of early and late development of postoperative right-sided heart failure (RHF) and subsequent mortality and morbidity. The secondary purpose of the study is to combine echocardiographic, hemodynamic, laboratory, and clinical data to define optimal management strategies of RHF after LVAD implantation.

NCT ID: NCT03552393 Not yet recruiting - Anemia Clinical Trials

Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

Start date: May 30, 2018
Phase: Phase 2
Study type: Interventional

Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.

NCT ID: NCT03547583 Not yet recruiting - Clinical trials for Chronic Heart Failure With Preserved Ejection Fraction

Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

VITALITY-HFpEF
Start date: June 15, 2018
Phase: Phase 2
Study type: Interventional

The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.

NCT ID: NCT03532984 Not yet recruiting - Stroke Clinical Trials

Beam Walking Across the Lifespan for Falls Prediction

BEAM
Start date: June 1, 2018
Phase:
Study type: Observational

Background: Dynamic balance keeps the vertical projection of the center of mass within the base of support while the center of mass moves. The age-related decrease in dynamic balance is a risk factor for falls. Dynamic balance tests are used to predict the risks for falls and eventual falls but the psychometric properties of most tests assessing dynamic balance are unsatisfactory and comprise no actual loss of balance while walking. Objectives: Using beam walking distance as a measure of dynamic balance, we will determine the psychometric properties, lifespan and patient reference values, the relationship with selected 'dynamic balance tests', and the accuracy of beam walking distance to predict falls. Methods: This cross-sectional observational study will examine healthy adults in 7 decades (n=432) at 4 centers. Center 5 will examine patients (n=100) diagnosed with Parkinson's disease, multiple sclerosis, stroke, and balance disorders. At Test 1, all participants will be measured for demographics, medical history, grip and leg strength, short physical performance battery, static balance on a force platform, and dynamic balance using beam walking (4m-long, 4, 8, and 12 cm wide) under single (beam walking only) and dual task conditions (beam walking while concurrently performing an arithmetic task). In addition, cognitive function (global cognition, attention, executive function, processing speed, memory) will be assessed. Patients and healthy participants age 50+ will be additionally measured for fear of falling, history of falls, miniBESTest, functional reach on a force platform, timed up and go, and reactive balance. At Test 2, 7-10 days after Test 1, healthy adults young and age 50+ (n=40) will be re-tested for reliability of beam walking performance. All participants age 50+ will be re-called to report fear of falling and fall history 6 and 12 months after Test 1. Conclusion: The investigators expect to find that beam walking performance vis-à-vis the traditionally used balance outcomes predicts more accurately fall risks and falls.