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NCT ID: NCT03579641 Completed - Heart Failure Clinical Trials

Precision Event Monitoring for Patients With Heart Failure Using HeartLogic

PREEMPT-HF
Start date: June 1, 2018
Phase:
Study type: Observational

The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study. Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.

NCT ID: NCT03579615 Completed - Clinical trials for Diabetes Mellitus, Type 1

Comparison of Day and Night Closed-loop With Faster-acting Insulin Aspart With Insulin Aspart

AP-MFT-01
Start date: December 23, 2020
Phase: N/A
Study type: Interventional

The main objective of the study is to determine whether automated closed-loop using faster-acting insulin aspart will improve glucose control and reduce the burden of hypoglycaemia over a 23-hour period compared to insulin aspart under conditions mimicking under-estimation of meal carbohydrate content or missed meal bolus. Faster-acting insulin aspart (FIASP) is a novel formulation of insulin aspart in which two additional excipients (L-arginine and Niacinamide) have been added, resulting in accelerated initial absorption and more than double the glucose lowering effect in the first 30 minutes after subcutaneous administration using insulin pump. To date, no closed-loop study has been performed to evaluate the benefit of faster-acting aspart over insulin aspart during closed-loop system use.

NCT ID: NCT03579095 Completed - Cognitive Change Clinical Trials

Investigating the Acute and Chronic Effects of an American Ginseng Root Extract on Cognition and Mood

Start date: May 4, 2018
Phase: N/A
Study type: Interventional

Ginseng refers to the extract of any slow growing perennial plant with a fleshy root, deriving from the Panax genus of the Araliaceae family. Ginseng root has been used as an intervention for the treatment of diabetes (Sotaniemi, Haapakoski & Rautio, 1995), boosting cognitive function (Scholey et al., 2010) and improving mental health (Ellis & Reddy, 2002). The most commonly used ginseng is Panax ginseng (Asia) and Panax quinquefolius (America). Ginsensosides are considered the core phytochemical compounds that contribute to the alleged beneficial effects of ginseng. In particular, ginsenosides Rb1 and Rg1 have been isolated and investigated for effects on cognitive function (Shin et al., 2016). Scholey et al. (2010) was one of the first studies to provide support for a beneficial cognitive effect from American ginseng (Cereboostâ„¢), with better performance on working memory in healthy young adults. Improvements were most profound for a single dose of 200 mg on working memory tasks, specifically immediate word recall and numeric working memory speed. Cereboost also increased self-rated calmness compared to placebo, suggesting ginseng can enhance aspects of mood. Similarly, Ossoukhova et al. (2015) compared a single 200mg dose to placebo to investigate whether beneficial cognitive effects extend to a middle-aged cohort. Here, Cereboost significantly improved performance on the Cognitive Drug Research (CDR) working memory factor, specifically improving spatial working memory at three hours post dose. Further study is required to evaluate ginseng specific effects with a standardized extract of P. quinquefolius, such as Cereboostâ„¢ on healthy participants. Significant results will have implications for investigating the neurocognitive effects in other populations, such as those with cognitive and memory problems.

NCT ID: NCT03578809 Completed - Clinical trials for ST Elevation Myocardial Infarction

A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

REAL-TIMI 63B
Start date: June 5, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult participants presenting with acute STEMI (ST segment elevation myocardial infarction). The study will enrol participants presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also undergo an index and an end of study CTA.

NCT ID: NCT03578120 Completed - Clinical trials for Immunization; Infection

Immunising Mums Against Pertussis 3

iMAP3
Start date: April 24, 2018
Phase:
Study type: Observational

This study will aim to recruit at least 70 children who participated in the iMAP2 study whose mothers received a pertussis vaccine in pregnancy as part of the iMAP2 trial and at least 15 children born to mothers who did not receive a pertussis vaccine in pregnancy. Blood samples will be obtained prior to and one month after the routine preschool booster vaccination and vaccine responses compared between children whose mothers received one of two pertussis vaccines or no pertussis vaccine in pregnancy. Children will be vaccinated with the routine booster vaccines by the study team on the same visit as the pre-vaccination bloods are taken.

NCT ID: NCT03577275 Completed - Dyslipidemias Clinical Trials

A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval

Start date: June 15, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo and positive controlled, 4 way crossover study assessing the ECG effects of therapeutic and supratherapeutic doses of icosabutate in healthy male and female subjects.

NCT ID: NCT03577171 Completed - Chronic Hepatitis B Clinical Trials

A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)

Start date: June 19, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV)

NCT ID: NCT03577145 Completed - Healthy Adults Clinical Trials

Impact of Inulin on Production of Phenolic Acids From Tomato Onion and Lovage Soup

Start date: July 27, 2017
Phase: N/A
Study type: Interventional

This is an acute human bioavailability study in self-reported healthy participants aged 20-70 years old. The investigators hypothesize that combination of polyphenolics from a soup rich in rutin and quercitin and the non-digestible carbohydrate (NDC) inulin will increase the production of phenolic acids by bacteria in the human colon and these will be detected in urine. Participants will attend for three arms in a randomized order: Tomato, onion and lovage soup (high polyphenol food), Inulin (NDC) or Mixture of tomato, onion and lovage soup and inulin. During each feeding study, urine, blood and stool samples will be collected at regular intervals for the duration of 24 hrs after consumption of test food. Participants will be asked to follow a low polyphenol diet for 2 days prior to the feeding study.

NCT ID: NCT03575962 Completed - HIV Infections Clinical Trials

A Study to Compare the Relative Bioavailability of Two Different Formulations of GSK3640254

Start date: June 18, 2018
Phase: Phase 1
Study type: Interventional

This is a first time in human (FTIH), 2-period study, to assess the relative bioavailability of a mesylate salt capsule of GSK3640254, compared to a bis- hydrochloride salt capsule of GSK3640254, in healthy subjects, administered following a moderate calorie and fat meal. The subjects will be randomized to 2 sequences, Regimen AB or Regimen BA. For Regimen AB: The Regimen A, which will include oral administration of GSK3640254 bis-hydrochloride Capsule 200 milligram (mg) (reference), which will be administered, in Period 1 and Regimen B will include GSK3640254 Mesylate salt capsule (test), 200 mg, which will be administered in Period 2. For the regimen BA, the regimen B, will be administered, in Period 1 and regimen A, in Period 2. Each of the regimens will be given orally as 2 capsules in the morning, as per randomization sequence. There will be a minimum washout of 7 days between each dose of study treatment. A total, of 14 subjects, are planned to be enrolled in the study. The maximum duration of the study from screening to follow-up is approximately 7 weeks.

NCT ID: NCT03575923 Completed - Clinical trials for Physical Activity and Wellbeing

Evaluating the Impact of Improvements in Urban Green Space on Older Adults' Physical Activity and Wellbeing: a Natural Experimental Study

GHIA
Start date: September 4, 2017
Phase:
Study type: Observational

Background: Creating or improving urban green space has the potential to be an effective and sustainable way to increase physical activity and improve other aspects of wellbeing in older adults. However, the size and quality of the existing evidence base is weak. There is particularly a lack of studies on older adults and in the United Kingdom. This study aims to evaluate the effect of four small local street greening intervention projects on older adults' physical activity and wellbeing over a one-year period. The street greening includes tree and flower planting, and artificial tree decorations. These projects are based in a deprived urban neighbourhood in Greater Manchester, United Kingdom. Methods: Eight unimproved comparison sites were selected to compare with the intervention sites. The researchers will measure physical activity and two other behavioural indicators of wellbeing (Connect: connecting with other people; and Take Notice: taking notice of the environment) using a newly developed observation tool. It is thought that the largest effect of the interventions will be on Take Notice behaviour due to improvements in the aesthetic quality of green space at the intervention sites. Baseline data collection occurred in September 2017 before the interventions were installed in November 2017. Follow-up data collection will be repeated in February/ March 2018 (6 months) and September 2018 (12 months). Discussion: The present study offers a rare opportunity to evaluate the before-and-after effects of small-scale changes in urban green space, in an understudied population (older adults) and setting (United Kingdom). Although the interventions are expected to have small effects on peoples' behaviour, this study will address key weaknesses in previous studies.