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NCT ID: NCT04031300 Withdrawn - Diabetes Mellitus Clinical Trials

Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device

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

This pivotal multicenter study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.

NCT ID: NCT04027504 Withdrawn - Preoperative Care Clinical Trials

Palatability of Antioxidant Biscuits

Fitabisc2
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Patients who are due to have planned bowel surgery will be invited to take part in the study. Those that consent, will be given a 5 day supply of 'Fitabisc' (a biscuit designed to have the potential to provide nutritional support).Participants will be asked to eat 4 biscuits a day for a minimum of 5 days prior to their surgery before they are admitted to hospital. They will be asked to complete questionnaires to record the palatability of the biscuit, how much of the daily amount they were able to eat and if they could not eat the full amount, the reason for this. Information will also be collected on patient's demographic and clinical details. We will follow participants' progress after surgery so we can be alerted to any possible medium to longer term adverse effects of eating the biscuit, though none are expected.

NCT ID: NCT04027205 Withdrawn - Clinical trials for Traumatic Rotator Cuff Tear

Surgery Versus PhysiothErapist-leD Exercise for Traumatic Tears of the Rotator Cuff

SPeEDy
Start date: March 3, 2020
Phase: N/A
Study type: Interventional

The SPeEDy study is a parallel group, pilot and feasibility randomised controlled trial (RCT) with integrated Quintet Recruitment Intervention (QRI) and further qualitative interviews. The study hypothesis is: In adult patients diagnosed with traumatic tears of the rotator cuff, is it feasible to conduct a future, substantive, multi-site RCT to test the hypothesis that physiotherapist-led exercise is not inferior to surgical repair of the rotator cuff in terms of clinical outcomes but is more cost-effective.

NCT ID: NCT04015921 Withdrawn - Clinical trials for Psychiatric Disorder

Self-Referencing Bias in Psychiatric Inpatients

Start date: January 2024
Phase:
Study type: Observational

People tend to detect and recognise self-related information more quickly and efficiently than other kinds of information. For example, in a cocktail party, people are usually able to attend to just one conversation at a time. Messages from unattended conversations are rarely registered. However, most people would still hear their own name mentioned in unattended conversations. Research has shown that this self-referencing advantage manifests an individual's normal cognitive function and emotional wellbeing. It may be influenced by self worth and strength of self-esteem. Changes in self-related processing are hypothesised in various psychiatric conditions such as dissociative identity disorder and affective disorders, but the connection is poorly understood. Existing research mainly relies on self-report measures, which can be subjective and time consuming. This project will initiate a new approach that the investigators have developed to objectively measure self-related processing. The aim is to investigate how patients suffering from common psychiatric disorders respond to self-related information relative to age-matched control participants. The investigators also hope to establish whether the objective measurement of the self can form a new pathway to improve early diagnosis of mental health issues.

NCT ID: NCT04011787 Withdrawn - Stroke Clinical Trials

The Relative Effectiveness of BOLUS Versus Continuous Nasogastric Feeding After Stroke: a Proof of Principal Study

BOLUS
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Patients with severe strokes are often unable to be take oral diet food and fluids safely because they cannot swallow effectively. Therefore, patients need to be fed via a tube placed through the nose into the stomach (nasogastric tube). Tube feeding can be given by the intermittent (bolus) method, whereby the feed is given over a short time (15 to 30 minutes), or by the continuous feeding method, where the feed is given continuously over 10-16 hours. Nasogastric feeding can be complicated by vomiting or reflux of the feed into the oesophagus causing aspiration of gastric contents into the lung and pneumonia. Nasogastric feeds can be given continuously or as bolus feeds. Healthy people eating normally take their diet in discrete meals. The human digestive system is adapted to intermittent food intake and is likely to work best if food is provided in this pattern, but the larger volume of the feed by this method may cause vomiting and aspiration. It is unclear which method is better for allowing normal digestive processes and reducing pneumonia due to aspirated feeds. There are no trials comparing these two feeding methods in patients with acute stroke. The aim of this small study is to determine if a trial comparing the two treatment approaches is feasible in patients with acute stroke, and to collect information on the effects on feed tolerance and digestion. In this study we will compare the effect of the bolus and intermittent nasogastric tube feeding on digestion and feed tolerance in 20 patients who need nasogastric feeding within 36 hours of a stroke. Patients will be randomly allocated to be given the feeds either by the bolus or by the continuous method for 7 days. During this time they will be examined every day. The study will examine how effectively food is digested by measuring the amount of feed given and the metabolic responses of the body by looking at changes in the level of blood sugar and digestive hormones. The investigators will also monitor complications such as vomiting, diarrhoea, and pneumonia. Patients will be randomly allocated to be given the feeds either by the bolus or by the continuous method for 7 days. This will provide information which will allow the investigators to design a larger definitive study to conclusively prove which method is more appropriate.

NCT ID: NCT04007822 Withdrawn - Clinical trials for Chronic Low-back Pain

Pain Navigator Tool for Self-management in Back Pain: PATiENCe Trial

PATiENCe
Start date: July 1, 2019
Phase:
Study type: Observational

This study explores the experience of physiotherapists and patients using the Pain Navigator Tool during outpatient musculoskeletal consultations.

NCT ID: NCT04001153 Withdrawn - Dental Caries Clinical Trials

Occlusal Compensation After the Hall Technique

CHAT
Start date: July 10, 2019
Phase:
Study type: Observational

The Hall Technique preformed metal crown (HTPMC) is used to treat decayed primary molars. The correct size is chosen and pushed over the tooth with no tissue removal. A side-effect of the HTPMC is the increasing of tooth's height changing the child's bite vertically, resulting in a premature contact on the crowned tooth. Clinical trials have looked at it and measured the initial and final vertical change (after the HTPMC placement) and have found that vertical dimension (VD) is re-established within a few weeks. They suggest that there might be a compensatory mechanism related to the crowned tooth/its opposing tooth. None of these trials measured how long it took the occlusion to return to its pre-crown state, merely observing at convenient follow-up times that it happens. Neither has there been any investigation into the mechanisms by which the compensation occurs. A pilot trial was conducted at Dundee Dental School (DDS) in 2013 to find the best and most reproducible method to measure the change in VD after HTPMC placement. It compared 4 different approaches: direct clinical measurement; clinical photographs; direct measurement of stone study models and digital subtraction of 3D models, showing that the most reliable method to measure the differences in VD was the digital subtraction of 3D models. This method could detect whether the occlusion returned to its pre-crown state regarding the overbite and also gave an indication of appropriate follow-up timeframe to evaluate this resolution. These are preliminary results and the pilot study was designed to guide future research. There were no previous reliable data regarding the evaluation of VD and its effects when this pilot study was conducted. A random sample size was selected to give insight to build a future power calculation for future studies. The investigators would like to continue this pilot work and carry out a full study recruiting children that are assigned to receive a HTPMC during routine appointments in the DDS. By understanding where occlusal compensation occurs in the mouth following placement of a HTPMC, and how long this takes to occur, more accurate information can be given to parents on what to expect following treatment, supporting joint treatment planning and decision making regarding the dental care of the child. In addition, where more than one crown is required, treatment planning can be timed more precisely to ensure future treatment is carried out at the optimal time.

NCT ID: NCT03995550 Withdrawn - Healthy Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Doses of LEO 142397 in Healthy People, Including Japanese

Start date: August 1, 2019
Phase: Phase 1
Study type: Interventional

This is the first clinical trial with LEO 142397. The purpose of the trial is to assess the safety and tolerability of LEO 142397, along with the pharmacokinetics (what the body does to the drug) and the pharmacodynamics (what the drug does to the body) in healthy people. The trial consists of 2 parts: - In Part 1, participants will receive a single dose of LEO 142397. There will be up to 8 different dose groups. - In Part 2, participants will receive a daily dose of LEO 142397 for 14 days. There will be up to 6 different dose groups. Each participant will be enrolled into 1 dose group in either Part 1 or Part 2.

NCT ID: NCT03962608 Withdrawn - Clinical trials for Non-Alcoholic Steatohepatitis

Safety and Tolerability of Yaq-001 in Patients With Non-Alcoholic Steatohepatitis

Start date: January 31, 2021
Phase: N/A
Study type: Interventional

Gut-derived endotoxaemia, microbial imbalance and bacterial translocation play an increasingly recognized role in the progression from non-alcoholic fatty liver disease (NAFLD) to its more advanced state, NASH (non-alcoholic steatohepatitis). Animal model studies confirmed that Yaq-001 reduces liver injury and prevents steatosis in these models which leads to the theoretical potential of Yaq-001 altering the microbiome and gut permeability in patients with NASH. The purpose of this clinical trial is to study the safety and tolerability of Yaq-001 in patients with NASH. Results from this study will lead to the design of future pivotal performance and safety trials for registration purposes. Candidate patients must be between 18-70 years old and have a clinical diagnosis of NASH, determined histologically or phenotypically, as well as meeting other clinical inclusion/exclusion criteria. Eligible patients will be randomly assigned to receive standard of care treatment plus Yaq-001, or standard of care treatment plus placebo). The treatment lasts for 48 weeks. During treatment, the patient will have 6 study visits. At all the visits, the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital. On two occasions the patient will have a liver Multiscan and on three occasions the patient will have a liver Fibroscan. 70 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.

NCT ID: NCT03944005 Withdrawn - Knee Arthroplasty Clinical Trials

Comparing Two Regional Anesthesia Interventions for Knee Arthroplasty.

Start date: July 2020
Phase: N/A
Study type: Interventional

Osteoarthritis of the knee is a common disease of the elderly and knee arthroplasty is indicated in severe cases to improve long term pain and function. Along with perioperative quality analgesia, functional recovery is paramount in the postoperative period.Loco-regional techniques provide effective analgesia and can mitigate several side effects of systemic opioids administration. Also, adequate motor sparing analgesia( to prevent weakness of the thigh muscle) following total knee arthroplasty (TKA) is therefore paramount to ensure effective rehabilitation, early recovery, readiness to discharge or timely hospital discharge. There are several motor sparing regional technique described in literature. Adductor canal block (ACB), use of intrathecal ( IT) morphine and local infiltration by the surgeons (LIA) are such examples. Previous studies have shown the combination of ACB and IT morphine to be superior than LIA in providing analgesia. Posterior knee infiltration (IPACK), involves blocking the branches of the tibial nerve which provides sensory innervation for the posterior aspect of the knee. In combination with ACB, a motor sparing analgesic intervention is possible for knee arthroplasty. Rationale for doing the study is to evaluate 1. The effectiveness of IPACK block as a part of multimodal analgesic approach to knee arthroplasty surgery. 2. Enhanced recovery from superior motor sparing analgesia. 3. early hospital discharge We hypothesize that, following total knee arthroplasty surgery, the combination of continuous adductor canal catheter and I-PACK blocks will achieve a decrease in the time to readiness to hospital discharge as measured by the following four criteria: (1) adequate analgesia; (2) independence from intravenous opioids; (3) ability to independently stand, walk 3 m (metres), return, and sit down; and (4) independently ambulate 30 m without limitation of time. We postulate this will occur by providing superior motor-sparing analgesia compared to LIA for knee arthroplasty surgery.