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NCT ID: NCT04307953 Recruiting - Clinical trials for Fibrodysplasia Ossificans Progressiva

Saracatinib Trial TO Prevent FOP

STOPFOP
Start date: August 5, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2 study, designed as a European multicentre 6-month double blind random-ized controlled trial (RCT) of AZD0530 versus matched placebo, followed by a 12 month trial comparing open-label extended AZD0530 treatment with historical control data. Study population: Male and female adult patients aged 18 years and older with a diagnosis of FOP who meet the inclusion (active disease) and exclusion criteria will be eligible for participation in this study. The total number of enrolled patients will be 20. Intervention: Patients will be randomized to receive either AZD0530 100mg once daily or matched placebo, taken orally for the first 6 months, immediately followed by an open-label extension in which all patients will receive AZD0530 100mg once daily oral dose for a further 12 months. Endpoints: Endpoints include objective change in heterotopic bone volume measured by low-dose whole-body computer tomography (CT) , [18F] NaF Positron Emission Tomography (PET) activity and patient reported outcome measures.

NCT ID: NCT04307797 Recruiting - Obesity Clinical Trials

Effect of Glucagon and Glucagon-like Peptide-1 Co-agonism on Cardiac Function and Metabolism in Overweight Participants With Type 2 Diabetes

COCONUT
Start date: January 18, 2022
Phase: Phase 4
Study type: Interventional

The study seeks to explore the cardiovascular effects of co-agonism at the glucagon and (glucagon-like peptide-1) GLP-1 receptor. Glucagon and exenatide will be intravenously infused into participants with type 2 diabetes (T2DM). Overall, the aim of the study is to further the investigator's understanding on the role these endogenous substances have on normal cardiac physiology, myocardial energetics and myocardial glucose uptake through a series of PET and MRI imaging studies

NCT ID: NCT04307576 Recruiting - Clinical trials for Leukemia, Acute Lymphoblastic

A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

Start date: July 13, 2020
Phase: Phase 3
Study type: Interventional

ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design.

NCT ID: NCT04307303 Recruiting - Neurogenic Bowel Clinical Trials

Electrical Stimulation of Abdominal Muscles for Bowel Management in People With Spinal Cord Injury

BOWMAN
Start date: July 7, 2021
Phase: N/A
Study type: Interventional

A well-managed bowel program is an essential part of daily life for many people with a SCI. Nevertheless, constipation is frequently reported (42-95%). Constipation embraces a spectrum of harms including both physical & psychological distress. Initial exploratory studies suggest abdominal FES may be useful for decreasing overall bowel management time, decreasing colonic transit time and reducing discomfort. The current study will seek to reproduce previous findings in a 12 week study, using overall bowel management time as a benchmark for establishing proof of principle. The study will include 36 people with a spinal cord injury aged 18 and over with an above T12 injury, a complete or incomplete lesion in a medically stable condition, one year or more after injury. Participants will be randomised into two groups. One group will receive abdominal electrical stimulation and the other group low dose abdominal electrical stimulation. Participants will be asked to keep a bowel diary and complete questionnaires examining quality of life and bowel management.

NCT ID: NCT04307108 Recruiting - Stroke Clinical Trials

Magic Glass Evaluation in People With Stroke

Start date: November 11, 2018
Phase: N/A
Study type: Interventional

Background: Virtual Reality (VR) technology may help to provide a way for stroke survivors to exercise in their own time at home, with remote clinical support. Before we introduce this technology we need to test that it will work alongside current health services for stroke survivors. Aims: To find out if using the MAGIC-GLASS solution alongside current healthcare care is usable and acceptable to stroke survivors and helps to increase rehabilitation time. Design: Measures before and after stroke survivors use the MAGIC-GLASS solution. Setting: Stroke survivors will use the MAGIC-GLASS solution in their own home. Population: adults (≥18 years) who have had a stroke at least two weeks before they enter into the study. Interventions: Our VR technology is called MAGIC-GLASS, and in order to use the solution the user puts on a headset which is connected to a computer. They can then see a VR environment in which they will be able to see virtual hands that respond to the movements of their own hands. It will also be possible to see a mirror image of their hands moving. The system will record how much they use the system and improvement in their movement. Regular contact will be made with a clinician who will be able to use the system to see (from their clinic) how the stroke survivor is doing and talk to them. Outcomes: We want to find out how the stroke survivors' movement changes over time and what they think of using the system. We will also ask clinical staff what they thought of using the system as part of healthcare provision to stroke survivors. Finally we want to find out how much it will cost to use the system.

NCT ID: NCT04306315 Recruiting - Psoriasis Vulgaris Clinical Trials

Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight

ADJUST
Start date: July 18, 2022
Phase: Phase 4
Study type: Interventional

This study investigates if an adjusted brodalumab dosage regimen will give improved efficacy in psoriasis in patients with a body weight of over 120 kg. The increased dosage regimen will be compared to the standard brodalumab treatment plus placebo.

NCT ID: NCT04304027 Recruiting - Multiple Sclerosis Clinical Trials

Exercise to Manage Fatigue in Progressive Multiple Sclerosis

Start date: December 10, 2019
Phase: N/A
Study type: Interventional

Fatigue is one of the most common and debilitating symptoms of Multiple Sclerosis (MS). Exercise is suggested as a way to improve fatigue, but it is not clear what the effects of exercise are on fatigue - especially in people with progressive MS. Therefore, this study aims to test the feasibility of a tailored exercise programme to help improve fatigue in people with progressive MS. To do this people with progressive MS who are experiencing fatigue will be randomly allocated to receive either a tailored exercise programme, a standard exercise programme, or their usual care. Both exercise programmes will be 8 weeks long and require participants to attend Falkirk Community Hospital twice a week. The standard exercise programme involves a moderate intensity interval training session using a stationary exercise bike. The tailored exercise programme is similar to the standard exercise programme, as participants will be prescribed the same type and duration of exercise; however, the difference between the 2 programmes is that the intensity of exercise performed during each session of the tailored exercise programme is dictated by the participant's level of fatigue. Participants will complete an exercise test, walking test, and questionnaires relating to fatigue, quality of life, depression and anxiety, sleep quality, and cognition before and 1 week after completing the exercise programme.

NCT ID: NCT04303364 Recruiting - Clinical trials for Cardiomyopathy, Diabetic

CARdiomyopathy in Type 2 DIAbetes Mellitus

CARDIATEAM
Start date: October 2, 2020
Phase:
Study type: Observational

The objective of the CARDIATEAM clinical study is to assess the uniqueness of diabetic cardiomyopathy (DCM) relative to other forms of cardiomyopathy using unsupervised clustering approaches based on deep phenotyping (clinical, imaging and biological) information.

NCT ID: NCT04302870 Recruiting - Clinical trials for Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Motor Neurone Disease - Systematic Multi-Arm Adaptive Randomised Trial

MND-SMART
Start date: February 27, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

MND-SMART is investigating whether selected drugs can slow down the progression of motor neurone disease (MND) and improve survival. The study is 'multi-arm' meaning more than one treatment will be tested at the same time. The trial started with 3 arms; drug 1 (memantine), drug 2 (trazodone) and placebo (dummy drug). A third drug, amantadine, was added in April 2023. The first two drugs, memantine and trazodone, were removed from the trial in September 2023 due to lack of benefit. The trial currently has 2 recruiting arms; amantadine and placebo. This allows the evaluation of each drug versus placebo. Participants will be randomly allocated to either of the recruiting arms. Medicines being tested are already approved for use in other conditions. MND-SMART has an 'adaptive' design. This means medicines being studied can change according to emerging results. Treatments shown to be ineffective can be dropped and new drugs can be added over the duration of the study. This will allow many treatments, over time, to be efficiently and definitively evaluated. The medicines being tested have been selected following a rigorous process involving a systematic, unbiased, and comprehensive review of past clinical trials data, as well as information from pre-clinical research (studies in laboratories), for MND and other related neurodegenerative disorders. Drugs have been ranked for inclusion in MND-SMART by a group of independent MND experts according to set criteria. These include consideration of how the drugs work, their safety profiles, and the quality of previous studies. New drugs will be selected for investigation in MND-SMART based on continuous review of constantly updated scientific evidence as well as findings from state-of-the-art human stem cell based drug discovery platforms. These can be added by substantial amendment to the protocol.

NCT ID: NCT04300556 Recruiting - Solid Tumor Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types

Start date: August 6, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer [OC], endometrial cancer [EC], non-small cell lung carcinoma [NSCLC], triple-negative breast cancer [TNBC]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A [OC and EC participants] and Part B [EC only]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the use of the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days, as mitigation strategy for interstitial lung disease (ILD); and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to further evaluate the safety, tolerability and preliminary efficacy of 2 treatment regimens with farletuzumab ecteribulin (MORAb-202) in participants with advanced EC and to determine the recommended treatment regimen for further development of farletuzumab ecteribulin (MORAb-202).