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NCT ID: NCT05104931 Completed - Pain Clinical Trials

PK Evaluation of a Nanoformed Oral IR Piroxicam Tablet in Healthy Subjects

Start date: December 2, 2020
Phase: Phase 1
Study type: Interventional

Piroxicam is a nonsteroidal anti-inflammatory medication and currently used to treat pain and inflammation caused by osteoarthritis or rheumatoid arthritis. The aim of this study is to study the pharmacokinetic behaviour of the new nanoformed 20mg tablet formulation of piroxicam in comparison with a reference 20mg piroxicam tablet formulation. The target of nanoforming is to improve the pharmacokinetic properties of drugs with low solubility, potentially leading to the use of lower doses with concomitant improvements in safety and tolerability. Piroxicam is an appropriate candidate to demonstrate the benefits of nanoforming due to its physiochemical properties. The efficacy of the Nanoformed Piroxicam is evaluated in comparison to the reference product Felden® Tabs 20 mg. The study also is conducted with a second reference product, Brexidol® 20 mg, or a nanoformed piroxicam tablet of a different strength, or study the effect of food intake on the absorption of the nanofomed piroxicam tablet. The study is conducted with healthy volunteers.

NCT ID: NCT05104892 Completed - Asthma Clinical Trials

Proof of Concept Study of Rilzabrutinib in Adult Participants With Moderate-to-severe Asthma

Start date: December 12, 2021
Phase: Phase 2
Study type: Interventional

This is a parallel, treatment, Phase 2, double-blind, 2 arm, 12-week Proof of Concept (PoC) study with 2 staggered cohorts (2 arms in each cohort) that is designed to assess the efficacy, safety, and tolerability of rilzabrutinib in adult participants (aged 18-70 years) with moderate-to-severe asthma who are not well controlled on ICS/LABA therapy. Study treatment includes investigational medicinal product (IMP) (rilzabrutinib or placebo) added-on to a background therapy of ICS/LABA (fluticasone/salmeterol [non-investigational medicinal product], standardized at screening). Background therapy of ICS/LABA will be withdrawn during the 12week randomized treatment period and resumed at the end of the IMP treatment period, as outlined below: - Screening period (4 weeks) - Randomized IMP treatment period (12 weeks ± 3 days) - Background therapy stabilization phase (4 weeks) - Background therapy withdrawal phase (4-5 weeks) - No background therapy phase (3-4 weeks) - Post IMP treatment safety follow-up period (4 weeks ± 3 days)

NCT ID: NCT05104242 Completed - Renal Transplant Clinical Trials

Kidney Transplant Low-AGE Diet Study

Transplant LAD
Start date: February 4, 2022
Phase: N/A
Study type: Interventional

The purpose of the present study is to test the feasibility of conducting a larger randomised controlled trial (RCT) which will investigate whether a diet low in toxins called advanced glycation end-products (AGEs) decreases skin autofluorescence (SAF; AGE accumulation in the skin) levels and improves heart and circulatory (i.e. cardiovascular) health in persons with a kidney transplant.

NCT ID: NCT05102812 Completed - Stroke Clinical Trials

Breakfast Group Interventions in Stroke Rehabilitation

BISTRo
Start date: February 17, 2022
Phase: N/A
Study type: Interventional

Current evidence shows that many people living with stroke experience major problems with eating and drinking. We know that this can lead to malnutrition, dehydration, reduced muscle strength and depression. It can also lead to longer stays in hospital, reduced ability to participate in rehabilitation and in the long term poorer quality of life. People living with stroke say the pleasure gained from eating and drinking changes after a stroke. They describe feeling embarrassed and ashamed and report a loss of self-confidence. Therefore, being able to eat and drink independently is essential for health and well-being. People with stroke welcome opportunities to address eating and drinking problems early in their rehabilitation and would like more opportunities to practice the necessary skills needed, to regain independence. Early rehabilitation interventions have the potential to improve long-term outcomes by providing strategies, assistive devices and rehabilitation as early as possible in stroke recovery. Health care professionals are using breakfast groups to provide opportunities to practice preparation and consumption of food and drink with enabling support. Consultations with patients and health care professionals have found that the processes involved in breakfast group interventions lack rigour and multi-disciplinary team coordination, thus leading to uncertainty about what outcomes are achieved for each patient. This co-designed study aims to find out if it is possible to improve patient outcomes by providing more intensive interventions in a breakfast group format delivered by a range of health care professionals over five days of the week. The intervention will be co-designed with a stakeholder group comprising of patients, carers and stroke unit health care professionals supported by an advisory group, comprising of experts in the field. The intervention will be delivered in three sites and it will include a tool kit to support the integrated assessment, care plan and outcome measures.

NCT ID: NCT05102682 Completed - Multiple Sclerosis Clinical Trials

Robotics for Mobility Rehabilitation in MS

RAPPERIII
Start date: March 10, 2017
Phase: Phase 1
Study type: Interventional

Title Prospective, open label, single arm, non-randomized, non-comparative feasibility study of Rex robot assisted rehabilitation exercise to enhance balance, mobility and upper limb function in people with Multiple Sclerosis "RAPPER III - MS Objective The objective of this study is to evaluate the feasibility and safety of the REX Robot when used for rehabilitation with people who have moderate to severe mobility restrictions due to MS. A secondary objective of the study is to explore the acceptability of the device to people with MS and its impact on impairments and functions commonly affected by MS. Study Sponsor Rex Bionics, Plc. Study Device REX Robotic powered exercise system Primary Endpoint • Completion of a transfer, stand, balance and walk rehabilitation session. - Unexpected Serious Adverse Events Secondary Endpoints - Completion of a transfer, stand, balance and walk rehabilitation program over Six-weeks - The Number of approached, screened, and eligible potential participants. Reasons for Ineligibility. (See 'RAPPER III- MS 007 Screening Loss Analysis REV 0 FINAL') - Functional Ambulation Classification (FAC) 1 - Activities-specific Balance Confidence (ABC) Scale 2 - Modified Falls Efficacy Scale (MFES) 3, 4, - Multiple Sclerosis Walking scale (MSWS-12) 5 - Multiple Sclerosis Impact scale (MSIS-29) 6 - ARMA (arm activity measure) 7 - Berg Balance Scale 8 - Timed unsupported steady stand (TUSS) 9 - Pain scale questionnaire (Visual Analog Score VAS) 10 - Modified Ashworth Score 11 - Spasticity Impact Scale 12 - Epworth Sleepiness Scale (ESS) questionnaire 13 - EQ-5D Health State Questionnaire 14 Questionnaires may be administered in person, by phone, email or in the post.

NCT ID: NCT05102578 Completed - Chronic Pain Clinical Trials

Understanding Persistent Pain Using a Decision Aid Tool in a Scottish Pharmacy Setting.

UPP
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Persistent pain describes long term pain that is present nearly every day. It is common and affects millions of people in the United Kingdom. The investigators want to explore people's experience of living with persistent pain and investigate how pharmacists can help people manage their pain. For this, the investigators will be testing a digital Decision Aid Tool (DAT) that includes a pain and lifestyle assessment as part of a pain consultation.

NCT ID: NCT05101850 Completed - Clinical trials for Mechanical Ventilation Complication

Metabolic Cost of IMT

Start date: October 18, 2021
Phase:
Study type: Observational

Mechanical ventilation is a life-saving intervention used worldwide. Despite this, critically ill patients who undergo mechanical ventilation commonly develop muscle weakness; this includes limb muscle weakness and diaphragmatic weakness. Physiotherapy interventions on critically ill patients include; mobilisation to improve limb muscle strength and function, and inspiratory muscle training which aims to target the diaphragm and accessory inspiratory muscles with the goal of improving endurance and strength. Whilst these interventions are standard practice in intensive care, little is known about the physiological load imposed on patients. The purpose of this study is to assess the feasibility of using indirect calorimetry (measured using the Beacon Caresystem) to measure the metabolic cost (oxygen consumption [VO2] and carbon dioxide production [VCO2]) of inspiratory muscle training and physical rehabilitation in mechanically ventilated intensive care patients.

NCT ID: NCT05101590 Completed - Clinical trials for Intraoperative Hypotension

Hypotension Decision Assist - Use, Safety and Efficacy

HDA-USE
Start date: October 22, 2021
Phase: N/A
Study type: Interventional

This clinical investigation will investigate whether Hypotension Decision Assist (HDA) is a feasible, safe and effective patient clinical decision support system to enhance an anaesthetist's ability to manage a patient's cardiovascular system when undergoing surgery. If successful, this study will provide evidence that the use of HDA facilitates beneficial outcomes for patients who have this device used.

NCT ID: NCT05101369 Completed - Healthy Volunteers Clinical Trials

A Study Assessing the Mass Balance, Pharmacokinetics, and Metabolite Profiles of a Single Oral Dose of [14C]-INCB086550

Start date: January 21, 2022
Phase: Phase 1
Study type: Interventional

To evaluate the absorption, metabolism, and excretion of 86550-106 in healthy males.

NCT ID: NCT05099640 Completed - Phenylketonuria Clinical Trials

A Study of PTC923 in Participants With Phenylketonuria

Start date: September 30, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this trial is to evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in participants with phenylketonuria as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (that is, the average of each respective treatment dose 2-week period of double-blind treatment).