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NCT ID: NCT04846816 Not yet recruiting - Heart Failure Clinical Trials

An Open Label, Single Dose Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure: a Phase I Clinical Trial

SUB CUT P1
Start date: April 22, 2021
Phase: Phase 1
Study type: Interventional

This is a single-centre, prospective, open-label, non-comparative clinical trial assessing the on-body performance of an investigational drug delivery device (SQIN-Infusor) in patients hospitalised due to HF.

NCT ID: NCT04846426 Recruiting - Alzheimer Disease Clinical Trials

Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech - FUTURE Extension

AMYPRED-FUTURE
Start date: November 19, 2020
Phase:
Study type: Observational [Patient Registry]

The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech, can predict change in PACC5 between baseline and +12 month follow up across all four Arms, as measured by the coefficient of individual agreement (CIA) between the change in PACC5 and the corresponding regression model, trained on baseline speech data to predict it. Secondary objectives include (1) evaluating whether similar algorithms can predict change in PACC5 between baseline and +12 month follow up in the cognitively normal (CN) and MCI populations separately; (2) evaluating whether similar algorithms trained to regress against PACC5 scores at baseline, still regress significantly against PACC5 scores at +12 month follow-up, as measured by the coefficient of individual agreement (CIA) between the PACC5 composite at +12 months and the regression model, trained on baseline speech data to predict PACC5 scores at baseline; (3) evaluating whether similar algorithms can classify converters vs non-converters in the cognitively normal Arms (Arm 3 + 4), and fast vs slow decliners in the MCI Arms (Arm 1 + 2), as measured by the AUC, sensitivity, specificity and Cohen's kappa of the corresponding binary classifiers. Secondary objectives include the objectives above, but using time points of +24 months and +36 months; and finally to evaluate whether the model performance for the objectives and outcomes above improved if the model has access to speech data at 1 week, 1 month, and 3 month timepoints.

NCT ID: NCT04843072 Not yet recruiting - Valve Heart Disease Clinical Trials

Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

BASELINE
Start date: May 2021
Phase: N/A
Study type: Interventional

Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses varies based on the patient's age at the moment of implantation, type and size etc2. TAVI has become the preferred treatment for degenerated aortic bioprostheses in elderly patients3. The median time since index surgical aortic valve replacement (SAVR) and for bioprosthetic valve degeneration is typically 8 - 10 years4-6. TAVI in this setting has proven to have equally favorable results as in native aortic valves7. Balloon expandable8 and self-expanding9 transcatheter heart valves (THV) can be used in a degenerated bioprosthesis and each have specific assets and limitations. TAVI in a failed bioprosthesis can cause coronary obstruction, THV migration, paravalvular leakage and prosthesis patient mismatch. The SAPIEN-3 / Ultra and EVOLUT R/Pro are the 2 most commonly used THV platforms in contemporary clinical practice including treatment of failing surgical aortic bioprostheses. Objective: To compare TAVI with EVOLUT R/Pro vs. SAPIEN-3 / Ultra in terms of device success. Study design: International multi-center randomized study with 1:1 randomization to TAVI with SAPIEN-3 / Ultra or Evolut R/Pro. Study population: 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) and selected for transfemoral TAVI by heart-team consensus. Investigational intervention: Transfemoral TAVI with SAPIEN-3 / Ultra or Evolut R/PRO Main study parameters/endpoints: 1. Primary endpoint is device success at 30 days Defined by - Absence of procedural mortality AND - Correct positioning of a single prosthetic heart valve into the proper anatomical location AND - Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2 2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.

NCT ID: NCT04842799 Not yet recruiting - Clinical trials for Breast Neoplasm Female

Digital Delivery of Information About Genetic Testing for Breast Cancer

BRCA-DIRECT
Start date: June 2021
Phase: N/A
Study type: Interventional

BRCA-DIRECT is a pragmatic, randomised, non-inferiority evaluation that aims to evaluate whether digital delivery of pre-test information for BRCA-testing in breast cancer patients is non-inferior to current standard practice of 1:1 delivery from a healthcare professional as measured by rate of uptake of the genetic testing.

NCT ID: NCT04842331 Recruiting - Clinical trials for Respiratory Tract Diseases

PREvent Viral Exposure aNd Transmission Study: a SARS-CoV-2 PEP Study (PREVENT)

PREVENT
Start date: April 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This is an open label controlled household-randomised trial designed to evaluate the efficacy of RESP301 alongside standard of care ("SOC") versus SOC alone.

NCT ID: NCT04842240 Recruiting - Breast Cancer Clinical Trials

Comparison of Patient Reported Outcome Measures Using the BREAST-Q Questionnaire in Patients Undergoing Pre Versus Sub-pectoral Implant Based Immediate Breast Reconstruction.

PROM-Q
Start date: September 1, 2019
Phase:
Study type: Observational

The PROM Q study aims to compare patient reported outcome measures (PROMs) in patients undergoing mastectomy and immediate implant based breast reconstruction (IBR). This is the commonest form of breast reconstruction and current advances in surgical technology have led to increasing number of patients having implants placed above the pectoral muscle (pre-pectoral), rather than below it (sub-pectoral). This has important benefits for patients including shorter surgery time, quicker recovery, and avoidance of animation deformity (visible muscle twitching of the reconstructed breast) as the pectoral muscle is not divided to cover the implant. However, potential disadvantages include rippling effect as the implant is covered by the skin and subcutaneous tissue only, as well as potentially higher risk of capsule (scar tissue) formation. By utilising a validated questionnaire (BREAST-Q), we will assess for any difference in PROMs between the two groups of patients. The results will provide valuable information for future patients when making an informed decision about their reconstruction options. This questionnaire study will include consecutive patients undergoing mastectomy and immediate IBR for breast cancer as well as for risk reduction at Leeds Teaching Hospitals NHS Trust. The study participants will undergo either pre- or sub-pectoral IBR based on their informed discussion with the clinical team. This is a non-randomised observational study.

NCT ID: NCT04841772 Recruiting - Healthy Clinical Trials

Exploring Muscle Breakdown During Exercise Recovery

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

This study will allow us to explore how muscle responds to heavy exercise. We will characterise rates of muscle protein breakdown and synthesis 24hours after heavy exercise with a post exercise protein polyphenol or placebo supplementation. This will inform strategies to help people recover from heavy exercise.

NCT ID: NCT04840251 Withdrawn - Clinical trials for Pulmnary Hypertension

Investigating a Well-being Review in Pulmonary Hypertension

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

Pulmonary Hypertension (PH) is a rare disease that makes patients easily become breathless. There is evidence that people with PH can benefit from exercise; we want to look at how they can access rehabilitation in their local community. Aim: To see if it is feasible to study physiotherapy well-being reviews in PH. Step 1: We will interview some patients with PH who have had rehabilitation and ask questions about their experiences. We will also ask what they think we should measure to show any difference their rehabilitation has made to them. The findings from Step 1 will help us to shape the details of Step 2, where we will conduct a small study to see if it is feasible to run a full study. Participants will be divided randomly into a treatment group and a control group. The treatment group will have a physiotherapy well-being review, leading to referral to their most suitable local rehabilitation service and follow-up after 6 months. The control group will receive brief exercise advice and follow-up after 6 months. The findings will help to design a full study and be shared with patients and health professionals.

NCT ID: NCT04840160 Completed - Clinical trials for Metabolic Disturbance

Influence of Tart Cherry Juice Intervention on Vascular Function

Start date: April 1, 2016
Phase: N/A
Study type: Interventional

Diets containing fruit rich in anthocyanins have been shown (in meta-analyses) to be beneficial for health, but intervention trials have shown inconsistent results. In this preliminary study we want to investigate the influence of a tart-cherry juice intervention on vascular function and explore metabolite profiles that may offer insight into their mechanism of action

NCT ID: NCT04839991 Recruiting - Clinical trials for Advanced and/or Metastatic Solid Tumours

Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.

POTENTIA
Start date: April 7, 2021
Phase: Phase 1
Study type: Interventional

FIH, Phase 1, open-label, multi centre study of CB307, a trispecific Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours to assess safety and torelability to determine MTD and RP2D.