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NCT ID: NCT04803240 Completed - Dry Eye Clinical Trials

Survey: Evaluation of Ocular Surface Disease Symptoms and Patient Satisfaction With Thealoz® Duo After 84 Days of Daily Treatment

Start date: April 1, 2019
Phase:
Study type: Observational

Multi-centre, international, non-interventional, prospective survey

NCT ID: NCT04802967 Completed - No Condition Clinical Trials

A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males

Start date: February 8, 2021
Phase: Phase 1
Study type: Interventional

Part A The primary objective of this study is to determine the single dose pharmacokinetics (PK) of ketoprofen lysine salt combined with gabapentin (KLS-GABA [80 mg-34 mg]) compared to KLS alone (80 mg) in healthy male subjects. The secondary objective of this study is: • To determine the safety and tolerability of a single oral dose of KLS-GABA (80 mg-34 mg) compared to KLS alone (80 mg) in healthy male subjects. Part B The primary objective of this study is to determine the pharmacodynamic (PD) effects of KLS-GABA in the Intradermal (ID) capsaicin model in healthy male subjects. The secondary objectives of this study are: - To further investigate the safety, tolerability, and PK of single oral doses of KLS-GABA and KLS alone. - To investigate the possible relationship between plasma levels of drug and efficacy in pain reduction.

NCT ID: NCT04802798 Completed - Clinical trials for Functional Bloating (Disorder)

Pre-FIBRe Study: Predeterminants of Fibre Induced Bloating Response.

Pre-FIBRe
Start date: April 19, 2021
Phase: N/A
Study type: Interventional

This study is an exploratory study aimed at gaining a greater understanding of the cause of abdominal bloating in response to two distinct fibre types. This is a single-center, interventional double blinded randomized cross-over study. Each participant will consume each of the study products (placebo, fibre 1 and fibre 2) for a 7-day period with a 3-week washout period in between. Outcomes will be measured before and after each intervention period.

NCT ID: NCT04798911 Completed - Sjögren's Syndrome Clinical Trials

SS-INQ Information Needs Questionnaire in Sjögren's Syndrome

SS-INQ
Start date: October 12, 2018
Phase:
Study type: Observational

Patients with some long-standing rheumatic diseases have stated that they want to be fully informed about their disease as they find it 'more scary not to know' about possible complications and consequences. Patients who have the information they want about their disease can fully take part in decisions about their own health creating a partnership with their doctor. Sjögren's Syndrome (SS) is a multi-system, long-standing rheumatic disease that has a negative impact on the daily life of patients. A common presentation of this disease is dry mouth, which can make talking, eating and swallowing more difficult. Project aims: We aim to ask patients with SS what information they think it would be important to know about SS. We plan to create a questionnaire that can be used by doctors to help deliver the right information to patients at hospital visits. Timescale: This project will take 36 months to complete. Clinical relevance: This questionnaire could be used in daily practice. It could help patients cope with their disease, take part in treatment decision and reduced uncertainty and distress.

NCT ID: NCT04796831 Completed - Healthy Subjects Clinical Trials

A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects

Start date: April 26, 2021
Phase: Phase 1
Study type: Interventional

Quizartinib, a selective FLT3 inhibitor, is being developed as a treatment for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The absolute oral bioavailability of quizartinib has not yet been studied. This study is designed to estimate quizartinib bioavailability of quizartinib following oral and intravenous (IV) administration.

NCT ID: NCT04795726 Completed - Clinical trials for Diabetic Retinopathy

A Study That Uses Data From Routine Eye Examinations of Patients Participating in Studies FIDELIO-DKD and FIGARO-DKD to Explore Whether Finerenone Can Delay the Progression of a Diabetes Complication That Affects the Eyes (Diabetic Retinopathy, DR)

DeFineDR
Start date: March 10, 2021
Phase: N/A
Study type: Interventional

Diabetic retinopathy (DR) is a diabetes complication caused by damage to the small blood vessels inside the retina at the back of the eye. Diabetic retinopathy may cause mild vision problems or eventually blindness. Diabetes is a condition that makes your blood sugar levels higher than they should be. In the early stages of diabetic retinopathy - called non-proliferative diabetic retinopathy (NPDR)- increased blood sugar levels lead to damage to the tiny blood vessels of the retina. This damage results in small outpouchings of the vessel lumens leading to rupture. At the same time the blood vessels can leak and making the retina swell and can cause so called macula edema. In these early stages of DR current treatment to reduce the risk of this eye complication is focused on controlling blood sugar levels and blood pressure. Participants in this study have NPDR, Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD), a condition in which the kidneys become damaged and do not work as they should. These participants are already taking part in one of the phase 3 studies (FIDELIO-DKD and FIGARO-DKD). They study the effect of Finerenone on delaying kidney disease progression and reducing the risk of events that may cause damage to the heart and blood vessels To learn more about the effect of Finerenone on diabetic retinopathy, data from routine eye examinations performed during the two phase 3 studies will be collected and analyzed. All male and female participants included in this study are at least 18 years.

NCT ID: NCT04795115 Completed - Stroke Clinical Trials

The ARCAS Study: Auditory Rhythmical Cueing for Gait in Acute Stroke

ARCAS
Start date: February 4, 2019
Phase:
Study type: Observational [Patient Registry]

Difficulties with walking is a common and distressing problem following stroke and can lead to reduced independence. Research suggests that using an auditory cue, such as a regular beat or pulse, as part of rehabilitation can improve walking. It is also recommended that early rehabilitation following stroke delivers the bestoutcome for patients. Study aim:To determine whether the use of auditory cueing in early stroke rehabilitation is feasible during a balance and gait therapy programme. Study participants: Adults following acute stroke with walking problems. Participants must be able to sit unsupported and stand with assistance of 1 or 2 people. They will be recruited from the acute stroke unit at North Tyneside General Hospital 2 days to 4 weeks following stroke. A total of 12 participants will be recruited. Study setting: Acute stroke unit - North Tyneside General Hospital and participants homes if they are discharged within the study period. Intervention:Participants will receive auditory rhythmical cueing intervention targeting balance and gait for 30 minutes x5 / week for 3 weeks within the physiotherapy gym on the stroke unit or at home if discharged within the intervention period. The 30 minutes will consist of balance exercises and walking practice using auditory cueing with a metronome. Measures:1. What the participants and the therapists think of the intervention will be assessed by questionnaires. The questionnaires contain open and closed questions and have been developed specifically for this study. 2.The stroke survivors trunk control, balance and walking will be assessed before and after the intervention. Study Duration: 12 months Future Plans: This study will be used to inform a larger study testing if the intervention works and how much it costs

NCT ID: NCT04794153 Completed - Clinical trials for Nutritional Intervention Using Protein Rich Whole Food Sources

Investigating the Consumption of Different Protein Rich Whole Food Sources on Muscle Growth in Trained Males and Females

FFT
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Background To date, most of the literature investigating the role of dietary protein in muscle growth has focused on isolated protein sources. However, dietary protein is most commonly consumed within a whole food source. Consuming dietary protein within a whole food matrix may additionally stimulate muscle growth. The idea being, there may be other components within food, capable of producing a greater response. Objectives: To assess the effect of consuming a variety of whole food sources, on the stimulation of muscle growth compared to an isolated protein source following a single bout of lower body resistance exercise. Methods Young healthy resistance-trained volunteers will consume a protein rich whole food source, following a bout of lower body resistance exercise. Stable isotope IV infusions and repeated blood and muscle samples will be taken to assess protein digestion and absorption, as well as muscle protein synthesis rates. Value of Research: To determine whether whole food sources potentiate muscle protein synthesis rates (and to what extent across whole food sources) compared to an isolated protein source. In doing so, we can further investigate the nutrients involved that may be contributing to this effect.

NCT ID: NCT04792411 Completed - Clinical trials for Aortic Aneurysm, Abdominal

Adherence and Acceptability of a Remote, Home-based, Pre-surgery Programme for Patients Undergoing Abdominal Aortic Aneurysm Surgery

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Design A multi-centre pilot study investigating the acceptability and adherence of a prehabilitation on patients requiring abdominal aortic aneurysm repair. Setting 3 NHS Hospital Vascular Surgery Clinics in the UK. - Imperial College Healthcare NHS Trust - Cambridge University Hospitals NHS Trust - Mid and South Essex NHS Trust Patient Population Patients referred to secondary/tertiary vascular clinic for the repair of asymptomatic infrarenal Aneurysm Intervention: Baseline (conducted face-to-face): After providing written informed consent, participants will be provided with information about the prehabilitation programme. The following data will also be collected: baseline demographic characteristics (including age, sex and ethnicity), body mass index (BMI), medical history (including time since diagnosis), current medication, aneurysm diameter, health-related quality of life (EQ-5D-5L and EQ-VAS), smoking status and psychological wellbeing (using the Hospital Anxiety and Depression Scale; HADS) and Frailty assessments( QMortality Index, Electronic Frailty Index, Rockall score). Participants will also complete a 6-minute walking test(6MWT).

NCT ID: NCT04792268 Completed - Diabetes Mellitus Clinical Trials

Electronic Clinical Decision Support for Diabetes and Dysglycaemia in Secondary Mental Healthcare

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

People with serious mental illness (SMI) such as schizophrenia, schizoaffective disorder and bipolar affective disorder have a significantly reduced life expectancy, caused in part by increased incidences of mortality from physical health conditions such as cardiovascular disease (CVD) and diabetes. Electronic clinical decision support systems (eCDSS) offer clinicians patient-specific advice and recommendations based on clinical guidelines, theoretically overcoming obstacles in the use of existing paper-based guidelines. Adoption of eCDSS to address CVD risk in people with SMI presents a unique opportunity for research, but requires evidence of acceptability and feasibility before scaling up of research. The key objective of this study is to establish the feasibility and acceptability of an eCDSS (CogStack @ Maudsley) compromising a real-time electronic health record powered alerting and clinical decision support system for diabetes management in secondary inpatient mental healthcare settings. End-users of the eCDSS will be clinicians only. Firstly we will conduct initial surveys and interviews with clinicians on inpatient wards to scope experiences of managing diabetes in secondary mental healthcare settings and attitudes towards use of digital technologies to aid in clinical decision making. A feasibility study will then be run to evaluate the acceptability and feasibility of implementing eCDSS on inpatient wards. This will involve a cluster RCT on inpatient general adult psychiatry wards, where 4 months of eCDSS use by clinicians on intervention wards will be compared to 4 months of treatment as usual on control wards. All clinicians on recruited wards will be eligible to participate. At the end of the study, participating clinicians on intervention wards will be invited to take part in a survey and interview which will explore their experiences and attitudes towards using the eCDSS, and an implementation science framework will be applied to inform future implementation of eCDSS. Group level pseudonymised outcome data will be gathered through a separate study.