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NCT ID: NCT05198024 Completed - Clinical trials for Cardiometabolic Syndrome

Nutrition Education in Cardiac Rehabilitation

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Coronary heart disease is one of the United Kingdom's biggest killers. In the UK alone 175,000 myocardial infarctions are recorded annually. To lower the financial burden on the National Health Service, cardiac rehabilitation facilitates a systematic and multidisciplinary approach to secondary prevention aimed to improve functional capacity and health-related quality of life, lower rehospitalisation rates and reduce all-cause and cardiovascular mortality with exercise training being the cornerstones. The effectiveness of Cardiac rehabilitation programmes in delivering effective secondary prevention has long been established. Improvements are recorded in cardiovascular endurance, muscular strength and endurance, balance, co-ordination, and quality of life. However, many patients see little or no change in body mass and body mass index, an independent risk factor for coronary heart disease. Interestingly, the inclusion of nutrition education is rarely reported within specific Cardiac rehabilitation settings, therefore evidence of best practice remains elusive and warrants further investigation. The aim of this trial is to compare: - Usual care - Where patients access to two exercise classes per week and all facilities normally available as part of their cardiac rehabilitation programme. Patients in this group will undergo this approach for 12-weeks. - Usual care + Biggest loser - In addition to Usual care, patients in this group took part in the 'Biggest loser' program in which the patients attended weekly sessions outside of their usual exercise class times. Each session follows a specific theme based on British Heart Foundation healthy eating guidelines. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks. - Usual care + New Education programme. In addition to Usual care, the same weekly topics as the biggest loser are covered yet with bespoke information regarding portion sizes and recipes provided each week and patients given a challenge each week in relation to the topic being covered e.g. include more vegetables. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks. Patients will be tested at baseline, 6-weeks and 12-weeks.

NCT ID: NCT05196815 Completed - Clinical trials for Cardiovascular Abnormalities

Novel Echocardiographic and Invasive Haemodynamic Measurements in the Assessment of Patients Low Flow Low Gradient Aortic Stenosis Undergoing TAVI

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

In this study the investigators will assess a variety of novel markers of heart strength (contractility) and assess whether they can give a clearer indication of how well patients with weak hearts respond to the TAVI procedure. The investigators will perform a stress echocardiogram prior to each TAVI procedure and measure the global longitudinal strain (GLS) in the left ventricle (LV) heart muscle, a detailed marker of muscle strength. The investigators will then proceed to the TAVI procedure and measure the contractility of the main pumping chamber in the heart before and after giving a very low dose of an adrenaline -like drug (dobutamine). The patient will already have received this short acting drug (at the same and higher doses) during their routine care planning stress echocardiogram.

NCT ID: NCT05195892 Completed - Healthy Volunteers Clinical Trials

Investigate Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers

Start date: February 3, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess bioequivalence of the granule formulation of alpelisib as compared to the film-coated tablet formulation in healthy volunteers in the fed state. In addition, the food effect of the granule formulation will be investigated between the fed state and the fasted state.

NCT ID: NCT05195723 Completed - Healthy Volunteer Clinical Trials

Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers

Start date: May 11, 2022
Phase: Phase 1
Study type: Interventional

This study in healthy human volunteers will investigate the effects of a single dose (SAD) and multiple days of dosing (MAD) of WP1122 administered as an oral (PO) solution. Dose escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has completed at least 3 dosing cohorts in which WP1122 is found to be safe and well-tolerated. This study in healthy volunteers will explore safety and PK, and subsequent clinical development will be in patients infected with SARS CoV-2 in the setting of continued safety and favorable risk/benefit.

NCT ID: NCT05195008 Completed - Healthy Volunteer Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With Target Occupancy Study of BIIB113 in Healthy Participants

Start date: January 24, 2022
Phase: Phase 1
Study type: Interventional

Parts A and B: The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB113 in healthy participants. The secondary objectives of this study are to evaluate the single and multiple oral dose pharmacokinetic (PK) profile of BIIB113 in healthy participants and to evaluate the effect of food on the single oral dose of BIIB113 in healthy participants of Part A cohort 3. Part C: The primary objectives of this study are to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB113 in healthy participants and to determine target occupancy (TO) as measured by O-GlcNAcase-Positron Emission Tomography (OGA-PET) of single and multiple oral doses of BIIB113 in healthy participants.

NCT ID: NCT05194956 Completed - Clinical trials for Orthodontic Patient Experience

Orthodontic Patient Experience of Intraoral Scans Versus Alginate Impressions

OPESI
Start date: May 31, 2022
Phase: N/A
Study type: Interventional

CONTEXT: Digital scanning systems are becoming more and more popular with the advent of the COVID-19 pandemic. The risks surrounding aerosol-generating procedures (AGP) has resulted in practitioners changing their normal practice and finding alternative methods to continue managing their patients. Digital (intraoral) scanners are often used to show patients treatment options and help in educating them regarding their oral hygiene as it produces an almost instant digital image of their teeth. Conventional methods using alginate impressions produce study models which are created in dental plaster or stone, involving a lab cost and a greater environmental impact but remain a popular method of recording a patient's teeth and bite. OBJECTIVE: To investigate patient experience, operator experience and preference in intraoral scanning versus alginate impression taking in the orthodontic setting. DESIGN, SETTING AND SUBJECTS: A randomised controlled two-period crossover trial to be conducted in a UK secondary care setting involving 84 participants ready to start orthodontic treatment, with no experience of impressions/intraoral scans in the last 2 years. Patients with cleft lip and/or palate or recent research involvement will be excluded. OUTCOMES: A modified visual analogue scale, will be used to measure patient and operator reported outcomes (e.g. patient comfort, operator confidence, perceived time taken and induction of cough/gag reflex) following an alginate impression or an intraoral scan using Trios® 3 intraoral scanner (3Shape). The time taken for each procedure will also be measured. Lastly, operator preference will be recorded. CONCLUSION: The proposed study aims to add to the limited evidence base, providing information regarding the use of intraoral scanners compared to alginate impressions from both the orthodontic patient and operator perspectives.

NCT ID: NCT05194124 Completed - Clinical trials for Bardet-Biedl Syndrome

Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Patients With Specific Gene Defects in the MC4R Pathway

Start date: December 21, 2021
Phase: Phase 3
Study type: Interventional

A trial to compare the weekly and daily formulations of setmelanotide in patients with genetic defects in the melanocortin-4 receptor pathway.

NCT ID: NCT05190419 Completed - Psoriasis Clinical Trials

Study to Assess the Efficacy and Safety of Orismilast in Psoriasis

IASOS
Start date: December 30, 2021
Phase: Phase 2
Study type: Interventional

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe plaque-type psoriasis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe plaque-type psoriasis and assess the safety aspects of these 3 different doses.The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.

NCT ID: NCT05188144 Completed - Heart Failure Clinical Trials

Real-world Dapagliflozin Experience in Patients With Heart Failure in United Kingdom.

EVOLUTION-HF
Start date: November 29, 2021
Phase:
Study type: Observational

Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients' health-related quality of life (HRQoL). On May 5, 2020, the US Food and Drug Administration (FDA) announced the approval of dapagliflozin for heart failure with reduced ejection fraction (HFrEF), regardless of whether the patient has diabetes. Subsequently, there have been additional approvals for this indication by regulatory authorities across the globe." Real-world observational data are necessary to describe dapagliflozin use in real-world settings with detailed clinical data on heart failure symptoms, outcomes, and HRQoL

NCT ID: NCT05187858 Completed - Clinical trials for NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors

A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors

Start date: September 22, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, dose escalation study of LNP3794 (BI3011441) in subjects with NRAS/KRAS mutated advanced or metastatic refractory solid tumors. The purpose of this study is to evaluate the safety/tolerability, pharmacokinetic and pharmacodynamic profile of the orally administered LNP3794 (BI3011441) as monotherapy at selected dose levels.