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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.

NCT ID: NCT03532633 Recruiting - Prematurity Clinical Trials

Supply With Micornutrients (Purine and Pyrimidine) in Infants: a Prospective and Observational Study

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

Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied

NCT ID: NCT03532412 Completed - Periodic Breathing Clinical Trials

Different Loop Gain Phenotypes in Patients With Chronic Systolic Heart Failure and Periodic Breathing

Start date: June 28, 2016
Phase:
Study type: Observational

Central sleep apnoea (CSA) is common in patients with chronic systolic heart failure (HFrEF). Various trials have shown a prevalence of 21 - 37% in this group of people. Up to 66% of patients with CSA and HFrEF present with periodic breathing (PB), which is considered being a marker of HF severity and poor prognosis. Brack et al. summarized data from cohorts, longitudinal studies and retrospective analyses showing an independently increased risk of death in HF patients with PB (HR 2.1-5.7 in five of seven studies). Furthermore, PB in HF patients is known to reduce quality of life and exercise performance and to increase sympathetic nerve activity as well as the probability of malignant cardiac arrhythmias. The pathogenesis of PB is characterized by an instability of ventilatory drive. The level of carbon dioxide (CO2) in blood and cerebrospinal fluid correlates linearly with minute ventilation. A high level of CO2 increases ventilation while hypocapnia dampens it. This control theory is based on the loop gain (LG), which represents the sensitivity and reactivity of the ventilatory system and comprises three components: The plant gain defines the capacity of the system to change PaCO2 in response to a change in ventilation (metabolic response). It is influenced by the lung volume as well as the anatomy of the thorax and the upper airways. The feedback gain is defined by the chemoreceptor responsiveness in reaction to blood gas changes. The controller gain is represented by the respiratory control center in the brain stem and defines the capacity of the system to change ventilation in response to a change in PaCO2 (ventilatory response). Sands et al. proposed and validated a mathematical model based on the ventilatory cycle pattern that quantifies the feedback loop. The ratio of ventilatory and cycle duration within the PB pattern is defined as the duty ratio (DR), which is the basis to calculate the LG. Any temporary breathing disturbance causing a PB pattern with a LG < 1 stabilizes within a few breathing cycles. A LG > 1 represents an unstable ventilatory response and slight changes of CO2 are accompanied by overshooting and undershooting of the ventilation. In that case, the polysomnography shows the typical pattern of waxing and waning of the tidal volume and effort. HF patients typically present with an increased LG due to an impaired left ventricular function and a hyperstimulation of pulmonary vagal receptors. Furthermore, Khoo showed an increased chemosensitivity (controller gain) as well as a decreased ventilatory capacity (plant gain) in this group of people. Sands and colleagues characterized PB considering the mean LG derived from several ventilatory cycles during non-REM sleep. This retrospective study of PB in HFrEF patients addresses the following questions: 1. Is a single LG value appropriate to characterize the individual PB? 2. Does the LG depend on sleep stage and body position? 3. Does the intraindividual LG variability allow for the discrimination of different PB phenotypes and, if so, do these phenotypes differ in further characteristics?

NCT ID: NCT03532126 Recruiting - Clinical trials for Midface Volume Deficit

A 52-week Clinical Investigation of Princess® VOLUME PLUS Lidocaine in Subjects With Midface Volume Deficit

PRIMAvera
Start date: March 28, 2018
Phase:
Study type: Observational

This investigation aims to confirm the safety and effectiveness of Princess VOLUME PLUS Lidocaine in midface volume deficit augmentation and includes a long term safety followup.

NCT ID: NCT03531762 Not yet recruiting - Healthy Clinical Trials

Effect of a Proton Pump Inhibitor on the Pharmacokinetics (PK) of Tepotinib

Start date: May 14, 2018
Phase: Phase 1
Study type: Interventional

This study will investigate in healthy subjects (i) the effect of omeprazole (proton pump inhibitor) co-administration on the single dose PK of tepotinib under fed conditions, and (ii) the effect of food on the single dose PK of tepotinib after co-administration of omeprazole and tepotinib. Furthermore, the study will assess the safety and tolerability of tepotinib alone and upon co-administration of omeprazole.

NCT ID: NCT03531216 Completed - Systemic Sclerosis Clinical Trials

Topical Rosemary Oil Application in Systemic Sclerosis

Start date: November 2, 2015
Phase: N/A
Study type: Interventional

The objectives of this prospective crossover, open-label, nonrandomized study are to estimate effect sizes of vasodilatation and sense of warmth after application of topical rosemary essential oil in patients suffering from systemic sclerosis.

NCT ID: NCT03530436 Recruiting - Clinical trials for Safety After Oral Intake

Comparison of Curcumin Bioavailability

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

The curcuminoids curcumin, demethoxycurcumin and bisdemethoxycurcumin can be found in the rhizome of turmeric (Curcuma longa). Curcumin is widespread used for colouring foods. Based on its natural low bioavailability and the number of its effects on human health, several approaches such as increasing its water solubility or inhibiting its metabolism were taken to improve its bioavailability. Pharmacokinetics of curcumin from various supplements using those different mechanisms have been compared to the one of native curcumin. The investigator's study here will compare the bioavailability of curcumin from eight different curcumin formulations with native curcumin and between themselves. The study will folllow a single dose (in form of curcumin formulations, normalized to 240 mg curcumin), placebo-controlled, randomized, double-blind, nine-armed crossover study design with ≥ 1-week washout periods. Plasma samples will be collected at intervals up to 24 hours after intake. Investigators will compare the pharmacokinetics between the different curcumin formulations and to native curcumin.

NCT ID: NCT03530267 Not yet recruiting - Colorectal Cancer Clinical Trials

Aflibercept and 5-FU vs. FOLFOX as 1st Line Treatment for Elderly or Frail Elderly Patients With Met. Colorectal Cancer

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

This is a controlled, open-label, randomized phase- II trial (1:1 randomization) investigating 5-FU + aflibercept and 5-FU + oxaliplatin in elderly and frail elderly patients with mCRC scheduled to receive first line treatment.

NCT ID: NCT03529890 Not yet recruiting - Clinical trials for Urinary Bladder Cancer

Radio-Immunotherapy Before Cystectomy in Locally Advanced Urothelial Carcinoma of the Bladder

RACE IT
Start date: November 2018
Phase: Phase 2
Study type: Interventional

A prospective, single arm, multicenter, Phase II-Trial to assess safety and efficacy of preoperative Radiation therapy before radical CystEctomy combined with ImmunoTherapy in locally advanced urothelial carcinoma of the bladder

NCT ID: NCT03529877 Not yet recruiting - Clinical trials for Recessive Dystrophic Epidermolysis Bullosa

Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa

Start date: October 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this clinical trial is to investigate the efficacy (by monitoring overall improvement of EB symptoms) and safety (by monitoring adverse events) of three doses of allo-APZ2-EB administered intravenously to patients with recessive dystrophic epidermolysis bullosa (RDEB).