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NCT ID: NCT04204486 Recruiting - Inflammation Clinical Trials

Health, Wellbeing and Performance in Law Enforcement Workers

Start date: January 3, 2020
Phase: Early Phase 1
Study type: Interventional

This study aims to assess current health and fitness of law enforcement workers in various roles, and to evaluate the impact of an exercise intervention on markers on physical and mental wellbeing in this population. The intervention will consist of an exercise programme specifically targeted at improving, physical fitness and reducing musculoskeletal pain. Participants will be randomised to three groups: a face to face intervention group, an online intervention group an a control group. Self-reported physical health, musculoskeletal complaints, quality of sleep and occupational stress will be measured via questionnaires. Pre and post measures of fitness will be measured via functional strength testing and a cardiopulmonary exercise test. Pre and post cognitive function will be measured via computer-based cognitive tests and brain functional near-infrared spectroscopy (fNIRS). Systemic inflammation will be measured via hsCRP. Risk of typeII diabetes will be measured via HbA1c. Daily physical activity and quality of sleep will be measured via accelerometry and heart rate telemetry. It is hypothesised that, upon completion of the programme, there will be an improvement in cardiovascular fitness and physical strength, reduced musculoskeletal pain, improved cognitive readiness and improved overall mental health and wellbeing.

NCT ID: NCT04204252 Recruiting - Clinical trials for Alpha 1-Antitrypsin Deficiency

Evaluate Efficacy and Safety of "Kamada-AAT for Inhalation" in Patients With AATD

InnovAATe
Start date: November 25, 2019
Phase: Phase 3
Study type: Interventional

The current study population will consist of adult patients with congenital alpha-1 antitrypsin (AAT) deficiency who have moderate or severe airflow limitation (forced expiratory volume in 1 second 40% ≤ [FEV1] ≤ 80% of predicted) and FEV1/slow vital capacity [SVC] ≤ 70% and who have not experienced two or more moderate or one or more severe exacerbations of COPD during the past year. A total of 220 patients will be recruited, and after 4 weeks practice inhaling saline with the nebulizer, will be randomized 1:1 to inhale either 80 mg/day "Kamada-AAT for Inhalation" or a placebo with identical appearance. Patients will be treated for 104 weeks and then followed up for a further 26 weeks. Over this time there will be 13 visits to the clinical site and in addition the patients will be required to fill out a daily e-diary.

NCT ID: NCT04203576 Recruiting - Heart Failure Clinical Trials

First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)

Start date: November 22, 2019
Phase: N/A
Study type: Interventional

First in Human Clinical Investigation of the FIRE1 Device/System to evaluate the feasibility and safety of implanting the FIRE1 system in stable HF patients.

NCT ID: NCT04201431 Recruiting - Malaria, Vivax Clinical Trials

Safety, Immunogenicity and Efficacy of the Blood-stage Plasmodium Vivax Malaria Vaccine Candidate PvDBPII in Matrix M1

Start date: January 24, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is an Open label, first-in-human, Phase I/IIa, blood-stage P. vivax malaria vaccine trial to assess the safety, immunogenicity and efficacy of the blood-stage Plasmodium vivax malaria vaccine candidate PvDBPII in Matrix M1 in healthy adults living in the UK.

NCT ID: NCT04201015 Recruiting - Clinical trials for Heart Failure, Systolic

Optimising Pacing for Contractility 2

OPT-cont 2
Start date: June 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). They have also demonstrated in an acute cross-over and a small parallel group feasibility study that keeping the heart rate in this range (versus standard rate-response programming) in patients with CHF is associated with increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a randomised, placebo-controlled 3-arm parallel group trial whether optimal programming versus standard rate-response programming versus no rate-response programming for 6 months leads to appreciable improvements in exercise time and quality of life, while having no adverse effects on left ventricular function and battery longevity and what the mechanisms of this might be. 400 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic assessment to establish the force frequency relationship and the optimal heart rate for contractility. They will then perform a treadmill walk test, complete quality of life questionnaires and be offered the opportunity to participate in a series of mechanistic substudies. They will then be randomised to optimal rate-response settings, standard rate response settings or no rate-response settings and followed up at 6 months at which point the tests will be repeated.

NCT ID: NCT04199936 Recruiting - Clinical trials for Postoperative Complications

Postoperative Electrical Muscle Stimulation (POEMS)

POEMS
Start date: November 18, 2020
Phase: N/A
Study type: Interventional

Patients lose a significant amount of muscle following major abdominal surgery. This is partly due to a catabolic response to the surgical insult and inflammation, but is also probably due to a lack of muscle use secondary to immobility. This study will aim to assess whether some or even all of postoperative muscle loss in the upper leg muscle group is preventable through electrical muscle stimulation to mimic physical activity.

NCT ID: NCT04199923 Recruiting - Muscular Atrophy Clinical Trials

Mechanisms of Disuse Atrophy in Human Skeletal Muscle (iMOB)

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

Loss of muscle can be caused by a variety of stimuli and results in reduced mobility and strength and also impacts whole body health. Whilst it is known that muscles waste the process by which this occurs is not well understood. Furthermore, whilst some muscles waste quickly others seem resistant to the effects of disuse. This study aims to evaluate how quickly changes in muscles start to occur, and investigate the processes which underlie muscle atrophy. By studying muscles which waste quickly and those which are resistant to atrophy this study aims to identify the different processes which lead to muscle loss. This study will also evaluate the differences in muscle changes between young and old people.

NCT ID: NCT04197388 Recruiting - Clinical trials for Pulmonary Hypertension

Inspiratory Muscle Training in Pulmonary Arterial Hypertension

Start date: June 26, 2019
Phase: N/A
Study type: Interventional

Pulmonary arterial hypertension is a rare condition characterised by high blood pressure in the lungs and results in breathlessness and reduced exercise capacity for patients. Previous research has shown weakness in respiratory muscles in these patients that may contribute towards their symptoms. Despite advances in medical therapy, the condition still results in a significant symptom burden. Inspiratory muscle training is a non-invasive intervention involving a device that provides resistance to the muscles of inspiration and increases their strength. This study will investigate the benefit of inspiratory muscle training in patients with pulmonary arterial hypertension who are stable on medical therapy for three months. This will be performed as an outpatient and they will then be reviewed following this with assessment of exercise capacity, breathing capacity (spirometry), quality of life, and assessment of neural respiratory drive (the signals from the brain to the muscles controlling breathing). The study will be based at the Golden Jubilee National Hospital and patients will be recruited from outpatients who are already under the care of the Scottish Pulmonary Vascular Unit.

NCT ID: NCT04196855 Recruiting - Stress Fracture Clinical Trials

Study of Teriparatide in Stress Fracture Healing

RETURN
Start date: December 23, 2019
Phase: Phase 3
Study type: Interventional

Investigation into the use of teriparatide in the treatment of stress fractures. Primary outcome is healing on MRI, secondary outcomes are pain, time spent in rehabilitation and future stress fractures. This study will help the investigators understand how to treat stress fractures in the future.

NCT ID: NCT04194463 Recruiting - Clinical trials for Gastric Adenocarcinoma

Maintaining Fitness During Neo-adjuvant Chemotherapy for Oesophago-gastric Cancer: a Feasibility Study

ChemoFit
Start date: February 28, 2019
Phase: N/A
Study type: Interventional

Feasibility study to investigate the utility of a simple, home-based, exercise intervention during and after neo-adjuvant chemotherapy but prior to surgery for esophageal and gastric adenocarcinoma.