Clinical Trials Logo

Filter by:
NCT ID: NCT02449434 Completed - Tooth Wear Clinical Trials

Timing of Dietary Acid Intake, Brushing Teeth and Acid Erosion.

Start date: May 2014
Phase:
Study type: Observational

This is a questionnaire based study investigating the relationship between the timing of dietary acid intake toothbrushing and erosive tooth wear. Data will be collected on the timing, nature, frequency and duration of dietary acid intakes and timing and frequency of the participants toothbrushing. Signs of the participants erosive tooth wear will then be recorded

NCT ID: NCT02448264 Completed - Clinical trials for Hereditary Angioedema

First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers

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

This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX7353 in healthy subjects, and single and multiple doses of BCX7353 in healthy Japanese subjects. Pharmacokinetics is an analysis of how the body handles the study drug BCX7353 and pharmacodynamics is an analysis of the activity the study drug BCX7353 may have in the body.

NCT ID: NCT02447952 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Exploratory Study of Biotelemetry in Amyotrophic Lateral Sclerosis

Start date: June 30, 2015
Phase: N/A
Study type: Interventional

Study 201283 is an exploratory, non-controlled, non-drug study in Amyotrophic Lateral Sclerosis (ALS) subjects. This study is being conducted as the first step for developing new meaningful measure(s) which might prove to be more effective than existing measures for monitoring clinical function and disease course in ALS. The objective of this study is to test novel measures of movement/physical activity, heart rate and speech and explore how they measure disease progression by evaluating their relationship to gold standard measures of function. This study will be conducted in two phases. A variable length Pilot Phase to test biotelemetry instruments and algorithms reliability and ease of use/acceptance. Approximately 5 subjects will have at least 1 clinic visit to perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (i.e., home monitoring). Subjects in the Pilot Phase will continue in the study and participate in the Core Study Phase. A 48 week Core Study Phase will be conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. During this phase, a maximum of 25 subjects will be enrolled. Subjects will attend 5 clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, every month subjects will attach the accelerometer and electrode and wear it for approximately 3 days in their home. A telephone contact with the subject will be made by the site at the end of each 3-day home monitoring period. All third party trademark rights are the rights of their respective owners.

NCT ID: NCT02447666 Completed - Clinical trials for Myelodysplastic Syndrome

Study With Azacitidine in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome (MDS) and Juvenile Myelomonocytic Leukemia (JMML)

Start date: September 15, 2015
Phase: Phase 2
Study type: Interventional

Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT). Objectives Primary Objective The primary objective is to assess the treatment effect on response rate (MDS: either complete remission [CR], partial remission [PR], or marrow CR; JMML: either clinical complete remission [cCR] or clinical partial remission [cPR]); at Cycle 3 Day 28 (each cycle is 28 days) and to compare against standard therapy using a matched-pairs analysis of historical data. Secondary Objective The secondary objective is to further evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of azacitidine in this subject population. Study Design This is a prospective, open-label, Phase 2 study consisting of 2 parallel experimental arms, one for each disease group: MDS and JMML. Each arm is designed based on Simon's Optimal 2 stage study design. The sample size has been calculated to allow evaluation of the response rate at 28 day-Cycle 3 Day 28 in each of the 2 disease groups. Each of the experimental arms will also individually be compared against a historical control arm using data retrospectively collected from the European Working Group of MDS in childhood (EWOG-MDS) registry by means of a matched-pairs analysis; matched for predefined subject baseline characteristics defined before any results from this study are known post Stage 1. If matched pair is not viable then other methodologies will be explored to evaluate and compare response rates reported in literature and also in registry database Twenty subjects with MDS and 35 JMML subjects evaluable for the primary endpoint (ie, subjects that receive at least 1 dose of investigational product [IP]) will be enrolled at approximately 45 centers in Europe. Each experimental arm has 1 interim analysis planned (at the end of Stage 1). If, during Stage 1 evaluation, less than 2 subjects are observed with a CR, PR, or marrow CR after 3 months of azacitidine in the first 9 subjects with MDS, then enrollment will be stopped. Similarly, if less than 3 subjects are observed with a cPR or cCR after 3 months of azacitidine in the first 18 subjects with JMML, then enrollment will be stopped.

NCT ID: NCT02447445 Completed - Clinical trials for Frail Elderly, Inpatients

Grip Strength Routine Implementation (GRImP)

Start date: July 2015
Phase:
Study type: Observational

Hand grip strength (GS) is a non-invasive marker of whole body skeletal muscle strength and function used in research and recommended as a simple inexpensive measure suitable for clinical use. Research has shown that low GS in hospital inpatients is associated with poor healthcare outcomes including increased postoperative complications, longer length of stay, increased functional limitations and disability. Measuring GS on admission to hospital has the potential to identify people at risk of poor healthcare outcomes allowing early intervention including focus on nutrition and mobility. Yet, GS measurement is not routinely used in clinical practice. The aim of this study is to evaluate the implementation of GS measurement into routine clinical practice in Medicine for Older People wards at UHS.

NCT ID: NCT02447315 Completed - Healthy Subjects Clinical Trials

A Study to Investigate the Effect of Oral Doses of Pilocarpine on Salivary Secretion and Static Pupillometry in Healthy Subjects

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

The purpose of this study is to evaluate the pharmacodynamic effect of oral doses of pilocarpine on salivary secretion in healthy male and female subjects. In addition, pharmacodynamic effect on static pupillometry will be evaluated as well as pharmacokinetics and safety and tolerability of oral doses of pilocarpine in healthy subjects.

NCT ID: NCT02447302 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis

Start date: October 15, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.

NCT ID: NCT02447172 Completed - Infection Clinical Trials

Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers

COACT-2
Start date: June 2015
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. After completing treatment, patients will return to the clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.

NCT ID: NCT02447081 Completed - Stroke Clinical Trials

Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)

Amulet™PMS
Start date: June 1, 2015
Phase:
Study type: Observational [Patient Registry]

This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."

NCT ID: NCT02447042 Completed - Sepsis Clinical Trials

Minimal Volume for a Fluid Challenge in Septic Patients

Start date: November 2014
Phase: N/A
Study type: Interventional

The administration of fluids intravenously is the first step in the stabilization of patients in septic shock. It is important to give the right dose of fluids, enough to improve the function of the cardiovascular system but not too much to drown the cells in water. In order to know that, the investigators use the "fluid challenge" which is the administration of a "small amount" of fluid in a short period of time in order to test the cardiovascular response to a dose of fluids. However, it is unclear how "small" this amount can be. The aim of this study is to find out the minimum volume required to perform an effective "fluid challenge". The investigators hypothesize that the changes in the mean pressure in the cardiovascular system (socalled mean systemic filling pressure or Pmsf) during the administration of small amounts of fluid can be used to detect the minimum volume required to effectively test the cardiovascular system with a fluid challenge. On the other hand, microcirculation may remain impaired despite the stabilization of the macrocirculation. The microcirculation can be much more dynamic than the macrocriculation, so it is essential to observe the changes of both over time. Patients admitted at the investigators' intensive care unit (ICU) due to sepsis can be included in this study. The sample will be divided in 4 groups according to the volume of the fluid challenge: 2 ml/kg, 3 ml/kg, 4ml/Kg and 5 ml/kg. The investigators will measure the Pmsf non-invasively using a pneumatic tourniquet inflated during one minute. Invasive arterial blood pressure will be observed during the inflation of the cuff in the arm to determine the Pmsf. The least significant change of Pmsf using this method is 14%. The minimal volume will be that one that achieve that change in Pmsf.