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NCT ID: NCT05713539 Not yet recruiting - Needle Phobia Clinical Trials

Determining Whether There is a Change in Time Taken to Return to Homeostatic Temperature With Repeated Exposure to a Cold Stressor

Start date: February 2023
Phase: N/A
Study type: Interventional

There has been previous research suggesting cold has an effect on pain relief, however there is limited knowledge on the relationship between exposure time of a cold stressor and how long it takes to return to homeostatic temperature and normal response to cold, in addition to whether location site affects this. The skin's thermal response to a cold stimulus is not fully understood. This provides precedent for potentially using cold stressors as a way to provide pain free injections. 5 participants will be exposed to a block of copper on the skin at -2°C for 30 seconds, and a thermal camera will be used to identify the amount of time it takes for the skin to return to its homeostatic temperature. The participant will then be left for 30 seconds before the experiment is repeated to identify if there is a change in the response to cold after the first exposure. If increased sensitivity in the response to cold occurs, the experiment will be repeated by adding an additional 30 seconds between repeats to identify the minimum time required between exposures that doesn't result in increased sensitivity. This will occur until there are two consecutive times with no increased sensitivity. This will occur on both the forehead and on the deltoid of the arm, two areas where injections are common. The cold stressor will be block of copper metal which will be cooled to this temperature.

NCT ID: NCT05713474 Recruiting - Electromyography Clinical Trials

Micro-EMG: A Novel Multi-electrode System for Intramuscular Imaging

Start date: April 26, 2024
Phase:
Study type: Observational

The purpose of this small-scale exploratory study is to bridge the knowledge gap between the bench testing and the design of potential future confirmative studies. Identifying and evaluating MicroEMG measurement parameters in this exploratory manner is a necessary step to evaluate its usability and design, and determine whether the microEMG system may be suitable for in-house use after further confirmative testing.

NCT ID: NCT05713409 Recruiting - Crohn Disease Clinical Trials

Prediction and Close Monitoring of Postoperative Recurrence by Intestinal Ultrasound After Ileocecal Resection in Crohn's Disease Patients

INSIGHT
Start date: February 10, 2022
Phase:
Study type: Observational

Crohn's disease (CD) is an inflammatory bowel disease causing chronic transmural inflammation followed by intestinal complications including strictures and penetrating lesions such as fistulas and abscesses. 30-50% of the CD patients will require surgery during the course of their disease. Unfortunately, resection is not curative and endoscopically recurrent lesions (i.e. endoscopic recurrence) are observed in 65-90% of patients within 12 months, and in 80-100% within 3 years after the operation. Eventually 15-20% of patients will require new surgery within 5 years. Close monitoring for postoperative recurrence is therefore needed to perform early intervention and prevent clinical recurrence and need for re-surgery. Endoscopy is the gold standard to assess postoperative disease recurrence however it's limited by its invasiveness. Cross sectional imaging is known for accurate detection of postoperative recurrence. Intestinal ultrasound (IUS) of the colon and (neo)terminal ileum correlates well with CT, MRE and colonoscopy findings in the postoperative setting. IUS is non-invasive, cheap, readily available and may show early, signs of disease recurrence. Therefore it could be a useful tool to predict endoscopic recurrence at 6 months.

NCT ID: NCT05713227 Completed - Healthy Clinical Trials

White Rice and Gellan Gum 7 Days Intervention

WIGG2
Start date: July 11, 2022
Phase: N/A
Study type: Interventional

Gellan gum (GG) is a food grade polysaccharide produced by fermentation. In-vitro studies and in vivo pilot studies suggest that adding gellan gum to rice during cooking might reduce the extent of the increase in circulating blood glucose seen after its consumption (glycaemic response). This study will explore whether such a modification in response is sustained, particularly over a period of 7 days of consumption.

NCT ID: NCT05712200 Recruiting - Clinical trials for Atrial Fibrillation (AF)

Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)

LILAC-TIMI 76
Start date: December 27, 2022
Phase: Phase 3
Study type: Interventional

A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.

NCT ID: NCT05711940 Recruiting - Clinical trials for Treatment Resistant Depression

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD

Start date: February 14, 2023
Phase: Phase 3
Study type: Interventional

Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)

NCT ID: NCT05711849 Recruiting - Refractory Angina Clinical Trials

Assessing the Safety and Effectiveness of Intracoronary Stem Cells in Patients With Refractory Angina

RegenCobra
Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

REGENERATE-COBRA will examine whether autologous stem cell treatment can improve angina symptoms and quality of life for patients with refractory angina. Patients will be randomised (randomly allocated with a 50:50 chance) to either the 'treatment' or the 'sham' group - they will not know which group they are in. In the 'treatment' group: - Stem cells will be collected from bone marrow in the patient's hip under local anaesthetic (a bone marrow aspiration). - Under local anaesthetic, the stem cells will be infused into the arteries that supply blood to the heart through a small tube inserted either in the wrist or the groin. - The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months. In the 'sham' group: - A sham bone marrow aspiration is performed - a 3mm nick in the skin will be made under local anaesthetic. - A sham cell infusion is performed - a small tube is inserted either in the wrist or groin under local anaesthetic. - The follow-up involves a phone call at 1 month and 12 months and clinic visit at 6 months.

NCT ID: NCT05711394 Recruiting - Episodic Migraine Clinical Trials

A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine

Kaleidoscope
Start date: May 1, 2023
Phase: Phase 3
Study type: Interventional

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with episodic migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

NCT ID: NCT05711290 Completed - Pulmonary Fibrosis Clinical Trials

Oxygen Nanobubble Drink Impact on Exercise in Pulmonary Fibrosis

Start date: March 21, 2023
Phase: N/A
Study type: Interventional

Approximately 1 in 5 (or 12.7 million adults) in the UK have longstanding respiratory illnesses, and 6.5 million patients report taking prescription medication to ease the burden. Many patients suffer from lung tissue damage, which impairs adequate blood oxygenation and reduces blood saturations, and causes breathlessness. The current method of treatment is palliative - with the patient breathing supplemental oxygen through an oxygen cylinder and tube. This severely compromises patients' quality of life, as they are tethered to a heavy, unwieldy oxygen cylinder, limiting their ability and willingness to leave home. Several recent studies in both animals and humans have indicated that orally administered oxygenated nanobubbles is a safe intervention that can improve tissue oxygenation. This randomized, double-blinded, cross-over, placebo-controlled study will evaluate the effect of an oxygen nanobubbles drink on the exercise performance of patients with chronic lung disease, such as pulmonary fibrosis. Patients will conduct the 6 Minute Walk Test (6MWT) twice, once with a placebo drink and once with the oxygen nanobubbles drink, based on a double-blind randomization protocol, and this study will evaluate the distance walked, heart rate, oxygen levels, breathlessness, and time to recovery in both cases. The investigators hypothesize that drinking the oxygen nanobubbles drink will improve the delivery of oxygen to vital organs, improving the distance a patient can cover in the 6 Minute Walk Test by 30m, which is the minimum clinically important difference.

NCT ID: NCT05711277 Completed - Malnutrition Clinical Trials

The Taste and Acceptability of a High Protein Ice Cream Compared With Hospital Milkshake Nutritional Supplement

Start date: June 20, 2022
Phase: N/A
Study type: Interventional

This study aims to compare the acceptability of a new high protein, fortified, ice cream called Nottingham-Ice cream (N-ICE CREAM) with a standard milkshake-style oral nutritional supplement (ONS); Fortisip Compact Protein in older patients admitted to hospital with fractures who require ONS as part of routine care.