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NCT ID: NCT03671980 Completed - Ulcerative Colitis Clinical Trials

IBD Self-management Website and Home Faecal Calprotectin Monitoring

Start date: April 4, 2017
Phase: N/A
Study type: Interventional

6 month exploratory feasibility study to assess if a combination of MyMedicalRecord supported self-management website and a home faecal calprotectin smartphone testing kit is a feasible and acceptable means for patients to monitor for signs of relapse after treatment de-escalation.

NCT ID: NCT03671434 Completed - Child Abuse Clinical Trials

Evaluation of the Research to Policy Collaboration Model

RPC
Start date: January 8, 2019
Phase: N/A
Study type: Interventional

This work aims to evaluate an approach for improving federal legislators' use of evidence-known as the Research-to-Policy Collaboration (RPC) - which seeks to address known barriers to policymakers' use of research, including a lack of personal contact between researchers and policymakers and limited relevance of research translation efforts to current policy priorities. The RPC involves structured processes for identifying policymakers' priorities, building researchers' capacity for nonpartisan responses to current policy priorities, and facilitating ongoing and productive researcher-policymaker interactions. This implementation of the RPC will focus on child and family policies relevant to child maltreatment. This study assesses both processes for collaboration and policymakers' use of research within a randomized controlled trial (RCT) employing a mixed methods approach-including quantitative and qualitative evaluation of impact. The proposed project will be guided by three overarching questions: 1. How does the RPC impact researchers and legislative staff? 2. How does the RPC impact legislative activity? 3. How might perceptions and experiences of collaboration through the RPC relate to different forms of evidence use among researchers and policymakers? The RPC's effectiveness will be tested through experimental design (randomization) using qualitative and quantitative assessments of researcher-policymaker interactions and impact. This includes surveying congressional staff and researchers, reviewing records of policymaker's public statements and introduced legislation, and conducting qualitative interviews around researchers' and legislative staffs' experiences with researcher-policymaker collaboration prior to and during the RPC.

NCT ID: NCT03670953 Completed - Clinical trials for Parkinson's Disease (Disorder)

A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations

Start date: November 6, 2018
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.

NCT ID: NCT03670810 Completed - Migraine Clinical Trials

A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Start date: June 24, 2019
Phase: Phase 3
Study type: Interventional

The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.

NCT ID: NCT03670706 Completed - Clinical trials for Osteoarthritis, Knee

Knee Pain Nurse Led Package of CareTrial

Team-KP
Start date: November 26, 2018
Phase: N/A
Study type: Interventional

1. To develop a training package for nurse-led management of knee osteoarthritis (OA), incorporating information about OA and core non-pharmacologic and pharmacologic principles of management of OA as recommended in the National Institute for Clinical Excellence and Health (NICE) guidelines for management of OA 2. To evaluate fidelity of delivery of individual components of this complex package of care for knee pain 3. To assess the acceptability of the intervention by exploring participant satisfaction with nurse-led complex package of care of knee pain. 4. To explore and resolve possible challenges to delivery of individual components within a complex package 5. To examine the feasibility of a definitive cohort randomised controlled trial of nurse-led care versus usual care of knee pain in terms of recruitment rate, drop-out rate, reasons for dropping out and completeness of outcome data 6. To explore whether such a trial should provide analgesia before non-pharmacologic interventions or vice versa

NCT ID: NCT03670693 Completed - Crohn Disease Clinical Trials

Non-invasive Approaches to Identify the Cause of Fatigue in Inflammatory Bowel Disease Patients.

IBD Fatigue
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Crohn's disease (CD) presents with severe symptoms, but fatigue is a very predominant symptom that negatively impacts upon quality of life. Fatigue affects ~40% of patients when well and 80% of patients when the disease is active. It is the second commonest symptom that an IBD patient gets throughout their life-time. The IBD priority-setting partnership between the James Lind Alliance and the British Society of Gastroenterology has recently identified fatigue as an area of unmet clinical need and a priority research field, in which diagnosis and therapeutic intervention are lacking. Based on other diseases that present with fatigue, the cause of fatigue may be divided into peripheral fatigue, mainly driven by anomalies in muscle mass and function and central fatigue, mainly driven through decreased blood supply to the brain during exercise probably due to decreased heart and lung fitness. Research in IBD fatigue until now has been patchy with no convincing evidence that any treatment helps. There has been no research aimed at studying whole body function. It is imperative to have a better understanding of the alterations in muscle, brain, heart and lung function seen in these patients before specific treatments are researched. In this study, the investigators aim to recruit 32 CD patients, half with fatigue and half without. Subjects with active disease or with other known reasons of fatigue will be excluded. Findings in this group will be compared to 16 other healthy control volunteers of a similar age, gender and Body Mass Index. The study aims to recruit all participants over 36 months, and will target people aged from 16 to 60 years of age. Once recruited, the participants will be asked to provide their consent to take-part in 3 experiments on two separate days. These experiments have been designed to carefully consider potential fatigue burden, experimental practicality, and participant availability. Objective 1: The investigators aim to measure muscle fitness and strength by asking subjects to exercise using a stepper, whilst body mass and composition will be measured using an X-ray. This session will take 2 hours and be undertaken on one day. Objective 2: Peripheral fatigue: The investigators aim to non-invasively measure the recovery of muscle physiology after exercise by using magnetic resonance imaging after 5 min of exercise undertaken with a limb cuff. This will take ~1 hour. Objective 3: Central fatigue: while in the scanner and performing exercise, the investigators aim to non-invasively measure heart and brain blood flow before and after a few minutes of exercise using magnetic resonance imaging. This will take 2 hours. Experimental work for Objectives 2 and 3 will be undertaken on the same day. There will be ample time for recovery in between and during the different studies. There will be no further commitment from the participants required after these 2 study visits. IBD fatigue has never been studied in such detail. This unique work will allow identification of fatigue mechanisms, which can then be targeted with exercise, nutritional, or medical treatments.

NCT ID: NCT03670082 Completed - Healthy Clinical Trials

Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State

Start date: September 5, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women

NCT ID: NCT03669770 Completed - Clinical trials for Type 1 Diabetes Mellitus

Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes

TITANIC
Start date: September 22, 2017
Phase:
Study type: Observational [Patient Registry]

This study will use ultrasound to characterise lipohypertrophy(LH) and assess the impact of LH on glucose variability in adults with type 1 diabetes. LH is a condition that occurs with repeated exposure to insulin at injection sites, resulting in the development of subcutaneous fatty lumps that impede the absorption of insulin. LH can lead to glucose variability, increased risk of severe hypoglycaemia and diabetes distress. In the long term it can therefore lead to increased risk of diabetes complications and increased insulin costs.

NCT ID: NCT03669588 Completed - Clinical trials for Generalized Myasthenia Gravis

An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

ADAPT
Start date: August 22, 2018
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.

NCT ID: NCT03668119 Completed - Pan Tumor Clinical Trials

A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

CheckMate 848
Start date: October 31, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.