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NCT ID: NCT04492839 Completed - Clinical trials for Gastroesophageal Reflux

Intestinal Adsorbent and Breath Gas Levels

Start date: August 13, 2019
Phase: N/A
Study type: Interventional

To determine the effect of an intestinal adsorbent on hydrogen and methane breath levels in patients who have been on long term PPI therapy reporting reflux and abdominal symptoms at baseline.

NCT ID: NCT04492709 Completed - Clinical trials for Cardiovascular Disease

A Study to Assess the Effect of Multiple Doses of AZD5718 on Pharmacokinetics of Oral Midazolam in Healthy Subjects

Start date: July 30, 2020
Phase: Phase 1
Study type: Interventional

In clinical practice, AZD5718 will be co-administered with CYP3A substrates. Therefore, it is important to determine the impact of AZD5718 on the pharmacokinetics (PK) of CYP3A4 substrates. The primary objective of this study is to evaluate the effect of AZD5718 on the PK of midazolam, a known sensitive CYP3A4 substrate.

NCT ID: NCT04492371 Completed - Multiple Myeloma Clinical Trials

COVID-19 Infection and Multiple Myeloma

EMN-COVID
Start date: July 1, 2020
Phase:
Study type: Observational

Collect in an observational study the outcomes of COVID19 infection in MM patients across Europe.

NCT ID: NCT04490044 Completed - Multiple Sclerosis Clinical Trials

Under and Over Rehabilitation Study

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Multiple Sclerosis (MS) is a progressive neurological condition of the central nervous system for which there is no cure. Symptoms include motor and sensory dysfunction, bladder and bowel dysfunction as well as speech and swallowing difficulties. It commonly leads to cumulative, mixed disabilities over time. The combination of different symptoms and disabilities often limits a person's ability to perform activities of daily living and to actively participate in social and occupational activities which then impacts on their quality of life. The two main strategies for managing MS symptoms include, medication and rehabilitation. However, historically treatment strategies have focused predominantly on preserving lower limb function thus strategies to improve upper limb function is often neglected. The importance of maintaining upper limb (hand and arm) function is significant for people who have already lost lower limb function. Further loss of functioning contributes to low mood, reduced independence and quality of life. This study aims to research how an engaging everyday activity, Under & Over, can become a rehabilitation tool to improve upper limb function in people with MS. The study will use a randomised wait list control group design, meaning that participants will be randomised to either the immediate rehabilitation group or the wait list group. Each group will perform the Under & Over task for 12 weeks, following a predetermined programme of instructions. Participants will complete a number of baseline measures measuring their current upper limb function, their quality of life and level of fatigue. This will happen at the start of the study, after 12 weeks of rehabilitation activity and again at a 12 week follow up.

NCT ID: NCT04489680 Completed - Cleft Palate Lip Clinical Trials

Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Trainees' experience in cleft surgery is limited due to the high-risk nature of the surgery and centralization of cleft care. Simulations allow trainees to learn complex surgical skills whilst ensuring patient safety. Existing cleft surgical simulators are over-simplified or prohibitively expensive. We developed and tested a high-fidelity yet cost-effective simulator for cleft palate repair. Skeletal elements were obtained through high-resolution scanning of a pathologic specimen, 3D printed and then molded in plastic. Soft tissue components were formed through molding layers of silicone. 26 UK specialty trainees performed a vomerine mucosal flap and intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft knowledge and surgical confidence were compared for statistical significance.

NCT ID: NCT04488900 Completed - Healthy Subjects Clinical Trials

Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects

Start date: July 6, 2020
Phase: Phase 1
Study type: Interventional

This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects.

NCT ID: NCT04488770 Completed - Clinical trials for Urinary Tract Infections

Safety, Tolerability and Pharmacokinetic Investigation of GSK3882347 in Healthy Participants.

Start date: August 24, 2020
Phase: Phase 1
Study type: Interventional

This is a phase 1, 2-part, double-blind (sponsor-unblinded), randomized, placebo-controlled, first time in human (FTIH) study, that includes both single-ascending and multiple-ascending dose phase to assess the safety, tolerability, and pharmacokinetics (PK) of GSK3882347 in healthy adult men and Woman of Non Childbearing Potential (WONCBP). Part 1 will be the single ascending dose (SAD) phase and Part 2 will be the multiple ascending dose (MAD) phase. Each participant in the SAD cohort will receive a single dose of GSK3882347 or placebo (PBO) in 3:1 ratio and in Part 2 (MAD), participants will be randomized in a 4:1 ratio to receive active treatment and placebo. Part 1 will consist of two cohorts with a maximum of four-period for each cohort, the food effect evaluation will be conducted in last period (Period 4) in only one of the cohorts based on the observed human pharmacokinetics (PK). Part 2 will consist of maximum of four cohorts for each of the MAD dose or placebo.

NCT ID: NCT04488705 Completed - Healthy Clinical Trials

A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects

Start date: August 13, 2020
Phase: Phase 1
Study type: Interventional

This is a first in human study of ETD002 a new drug being developed for the treatment of cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of ascending single and repeat doses of inhaled ETD002 in healthy male and female subjects.

NCT ID: NCT04485624 Completed - Clinical trials for Vaccination/Immunisation Status

Vaccination Coverage Amongst Children/Young People Attending the PED

Start date: January 24, 2021
Phase:
Study type: Observational

In the United Kingdom (UK), most childhood vaccinations are given in the community, although uptake has decreased in recent years. A Paediatric Emergency Department (PED) attendance offers an opportunity to check the vaccination status of children and young people (CYP) and all parents/carers should be asked about this routinely. Those not up-to-date with vaccinations could then be signposted to existing services or perhaps offered a vaccine in the PED. CYP attending the PED may also have lower vaccination coverage than their peers, so may benefit even more from interventions to increase uptake. However, recall by parents/carers is not always sufficiently accurate to identify those who have not yet received all their age-appropriate vaccinations. The most complete record of an individual's vaccination history is held within their primary care records. However, these records are often in a separate computer system that is inaccessible from the hospital's main computer system, although some information (including vaccination) may be accessed from within the hospital via a third system. This study aims to see if CYP attending the PED are under-vaccinated compared to their peers and assess the accuracy of parent/carer recall. The results of this study will then be used to inform recommendations for developing better ways to access accurate vaccination data during a PED consultation. If such a system existed, under-vaccinated children could be identified routinely during an attendance, and an intervention offered if appropriate. This would be particularly useful if there was an outbreak of a vaccine-preventable disease such measles. All CYP (< 16 years old) attending a PED in a district general hospital in Manchester will be invited to participate. CYP/their parent/carer will be asked to provide consent for their vaccination records to be accessed as well as being asked if the child/young person is up-to-date with all their vaccinations. Approximately 1000 participants will be enrolled.

NCT ID: NCT04484935 Completed - RSV Infection Clinical Trials

Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children

MUSIC
Start date: August 19, 2020
Phase: Phase 2
Study type: Interventional

Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the safety and tolerability, pharmacokinetic(s) (PK), occurrence of antidrug antibody (ADA), and efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time of dose administration. Approximately 100 subjects will be enrolled. Subjects will be followed for approximately 1 year after dose administration.