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NCT ID: NCT05926349 Not yet recruiting - Urgent Surgery Clinical Trials

A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

ANNEXA-RS
Start date: October 20, 2023
Phase: Phase 3
Study type: Interventional

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.

NCT ID: NCT05925998 Not yet recruiting - Clinical trials for Perioperative Complication

Mitochondrial Function in the Peri-operative Setting: an Observational Study

MITOSIS
Start date: July 5, 2023
Phase:
Study type: Observational

Complications after surgery are common and a burden for patients and health services. Therefore it is important that clinicians improve surgical outcomes. Mitochondria are the part of the body's cells that manage energy. Research has already shown that how our body's mitochondria behave can predict who survives in intensive care patients. The investigators think this could also predict who is more likely to develop complications after surgery. Therefore a study has been designed to find out if changes in mitochondria are related to postoperative complications. This will help doctors improve how they prepare patients for surgery and potentially how they manage their treatment, and result in improving outcomes for patients after surgery. This study will recruit patients scheduled for major abdominal surgery as part of their treatment. The investigators will take samples of breath, blood and muscle to measure changes in mitochondria from the day before surgery to 7 days postoperatively. The muscle samples will only be taken when the patient is asleep having their operation. These samples will be used to analyse mitochondria. This study will be in two phases. Phase 1 is a pilot of up to 10 patients focussed on feasibility. Following this there will be an interim data analysis. The results may allow further optimisation to reduce the patient burden, eg reduction in sampling frequency, or avoiding need for muscle biopsy. The second phase will be a full cohort study of up to 40 patients, focussed on association of mitochondrial markers with clinical outcomes, such as postoperative complications, oxygen levels, pain, confusion and length of intensive care stay. The results of this study could improve how doctors select and prepare patients for surgery. It may also affect how doctors manage their treatment during and after operations. This could result in reducing complications and illness burden for patients after surgery.

NCT ID: NCT05925985 Recruiting - Clinical trials for Chronic Rhinosinusitis (Diagnosis)

Propel Drug-Eluting Sinus Stent Family

Start date: June 1, 2023
Phase:
Study type: Observational

The purpose of this study is to confirm the long-term clinical safety and performance, acceptability of identified risks, and to detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling (in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery). Additionally, this study intends to collect data on use of corticosteroid-eluting implants in the European CRS population. Data collected will be used to ensure continued consistency between clinical data, the information materials supplied by the manufacturer, and the risk management documentation.

NCT ID: NCT05925803 Recruiting - Systemic Sclerosis Clinical Trials

Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)

DAISY
Start date: November 8, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.

NCT ID: NCT05925088 Recruiting - Clinical trials for Chronic Pain; Exercise

Exercise Videos - Perspectives of People Living With Chronic Pain

Start date: June 1, 2023
Phase:
Study type: Observational

Exercise videos on the internet are used by millions worldwide to provide structure and motivation. They can guide exercise execution and play a role in helping people to maintain regular exercise. On completion of the Pain Management Programme (PMP) at the Walton Centre, many patients are measurably more able bodied as a result (or at least part of a result) of regular engagement in exercise. Despite these positive outcomes and the patients stated intent to continue with exercise, many patients are struggling to maintain exercise in a meaningful way when re-assessed at their six month follow up appointment. Patients have expressed that videos of the exercises would have motivated them to engage in sustained regular exercise in a more meaningful manner. As physiotherapists, the investigators would like to ask a sample of patients on the PMP whether they anticipate exercise videos, reflecting the exercises practised on the PMP, would be beneficial for them to support maintenance/ sustainability of PMP exercises. Exercises practiced on the PMP include stretches, repeated movements in sitting, standing and lying, Pilates, yoga, normalised/functional movements and patients may like these exercises included in the videos. The investigators plan to approach this using two focus groups followed by a qualitative analysis of recorded transcripts of the group discussions. Data would be analysed using a thematic analysis to establish key themes related to the research questions. The information gathered will inform the value of and content / format of specifically developed exercise videos. The outcome of this project will inform the investigators of the use of exercise videos in this patient population and the value of this in encouraging people to keep up exercise over a sustained period. Other centres working with patients with chronic pain may be able to learn valuable lessons from this project in informing their own exercise promotion materials for their patients.

NCT ID: NCT05924542 Completed - Stress Clinical Trials

Kelaa Mental Resilience App for Employees

Start date: January 15, 2018
Phase: N/A
Study type: Interventional

The goal of this randomized control trial is to detect and prevent work-related psychological stress among European workers early on, aiming to mitigate its adverse health consequences, including burnout and depression. Soma Analytics has developed a smartphone-based system that comprises a diagnostic module utilizing smartphone sensors to collect and analyze stress biomarkers and an interventional module to reduce stress levels. The main questions this study aims to answer are: - Hypothesis 1: Compared to the waitlist control, after using the app for 4 weeks, participants in the app group will report (a) lower levels of stress (cognitive and general), (b) higher levels of wellbeing, (c) higher levels of resilience, and (d) fewer sleeping troubles. - Hypothesis 2: The observed effects will be more intense the more the user interacts with the app throughout the duration of the study. Participants (employees from six organizations in three European countries) will use the app for 4 weeks. Their levels of stress, well-being, resilience, and sleeping troubles are assessed at baseline, after 2 weeks (mid-intervention), 4 weeks (end of intervention), and 6 weeks (follow-up). Researchers will compare the intervention group with the waitlist control group to see if levels of stress, well-being, resilience, and sleeping troubles change over time.

NCT ID: NCT05924243 Recruiting - Parkinson Disease Clinical Trials

A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease

Start date: September 22, 2022
Phase: Phase 1
Study type: Interventional

This is a multi-center, randomized, double blind, adaptive, parallel-group, placebo controlled Phase 1b study to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics of RO7486967 in participants with idiopathic PD at the early stage of the disease (modified H&Y stage ≤2.5) who are either treatment-naïve or on stable treatment with symptomatic therapy (levodopa and/or pramipexole, ropinirole, rotigotine).

NCT ID: NCT05923827 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults

RADIANT
Start date: September 11, 2023
Phase: N/A
Study type: Interventional

This study is a randomized, controlled trial to evaluate the efficacy and safety of the Omnipod® 5 System with the FreeStyle Libre 2 continuous glucose monitor compared to Multiple Daily Injections (MDI) along with the FreeStyle Libre 2 continuous glucose monitor in children and adults with type 1.

NCT ID: NCT05923749 Recruiting - Wound Heal Clinical Trials

A RCT Evaluating the Clinical Benefit of a Silver Dressing in the Treatment of Venous Leg Ulcers

Start date: June 29, 2023
Phase: N/A
Study type: Interventional

Approximately 178 patients with a venous leg ulcer will be included in the investigation evaluating wound healing. All subjects are randomized to one of two treatment arms with an intervention period of 4 weeks followed by a 8 week standard of care period.

NCT ID: NCT05923099 Recruiting - Atopic Dermatitis Clinical Trials

A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis

Start date: September 20, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to test different doses of the trial medicine (LEO 138559) at treating moderate to severe atopic dermatitis in adults. There will be 4 different doses, that will also be compared to a placebo (a dummy medicine that doesn't contain the active ingredient of LEO 138559). Each participant will be randomly assigned to one of the 4 doses of LEO 138559 or placebo. In all arms, injections of placebo may be used to mask the different doses. The trial will last up to 36 weeks, including a screening/washout period (up to 4 weeks), a treatment period (16 weeks), and a follow up period (16 weeks). The participants will visit the clinic 17 times. For the first 4 weeks of the treatment period, participants will visit the clinic every week. For the next 12 weeks of the treatment period, participants will visit the clinic every 2 weeks. For the 16 week follow up period, participants will visit the clinic every 4 weeks. The treatments will be given to the participants by staff at the clinic. They are given as an injection just under the skin. At each visit the doctor will check the participants atopic dermatitis and if they have had any side effects. Participants will also complete an electronic diary every day about their atopic dermatitis and quality of life.