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NCT ID: NCT04909385 Active, not recruiting - Tuberculosis Clinical Trials

TB PCR in BAL and EBUS-TBNA

TRiBE
Start date: January 15, 2021
Phase:
Study type: Observational

This prospective observational multi-centre UK study will evaluate Xpert MTB/RIF Ultra for the detection of Mycobacterium tuberculosis (MTB) in bronchoalveolar lavage (BAL) samples for pulmonary TB and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) samples for mediastinal TB and compare the diagnostic performance against conventional modalities (smear, culture, cytology) as well as to a clinical composite diagnosis. This will be using a clinical expert panel reviewing data blindly. The Investigators will assess the performance of Xpert Ultra by calculating the sensitivity, specificity, positive predictive and negative predictive value in UK centres. The turn-around time of these modality and its effect on treatment decisions will be assessed. Finally the Investigators will correlate different clinical characteristics and to define the sensitivities in the various clinical presentations and to evaluate the phenotypes of patients with 'trace' results within these cohorts.

NCT ID: NCT04908202 Active, not recruiting - Psoriatic Arthritis Clinical Trials

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Start date: July 13, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

NCT ID: NCT04908189 Active, not recruiting - Psoriatic Arthritis Clinical Trials

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

Start date: July 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.

NCT ID: NCT04907084 Active, not recruiting - Clinical trials for Macular Telangiectasia Type 2

Serine and Fenofibrate Study in Patients With MacTel Type 2

SAFE
Start date: April 7, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2a study of the effect of serine supplementation and fenofibrate treatment on serum deoxysphingolipid levels in patients with macular telangiectasia type 2 (MacTel). This study involves six arms. Participants will be randomly assigned to one of the following treatment groups: serine 200 mg/kg/day, serine 400 mg/kg/day, fenofibrate 160 mg/day, both serine 200 mg/kg/day and fenofibrate 160 mg/day, both serine 400 mg/kg/day and fenofibrate 160 mg/day, or no treatment (control group). Serum deoxysphingolipid levels will be used as the primary outcome, and safety will be evaluated. The participants will be followed for 10 weeks, with visits at Screening, Week 0, 3, 6 and 10.

NCT ID: NCT04906460 Active, not recruiting - Clinical trials for Duchenne Muscular Dystrophy

Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)

Start date: September 28, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/2a open-label study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical effects of intravenous (IV) WVE-N531 in patients with Duchenne muscular dystrophy (DMD). To participate in the study, patients must have a documented mutation of the DMD gene that is amenable to exon 53 skipping intervention. This study has 2 parts, Part A and Part B. Part A is complete.

NCT ID: NCT04903834 Active, not recruiting - Covid19 Clinical Trials

Identification of Novel Factors Leading to Activated Macrophage Expansion in COVID19 - INFLAME Study

INFLAME
Start date: June 30, 2020
Phase:
Study type: Observational

This project aims to undertake a high-resolution analysis of previous cases of COVID19 infection to determine from all available clinical data recorded over the timeline of admission, who might benefit best from specific interventions designed to target a hyper inflammatory response in this condition. This approach offers a timely contribution to the field where the first phase of unselected clinical trials is already underway, and the second phase will require a more targeted approach. Southampton offers a unique opportunity to undertake this work, as it is widely accepted that the investigators lead the UK in clinical data informatics. This project links the investigators research efforts at the clinical level to current understanding of disease pathways, for which the investigators have effective interventions and the problem the investigators aim to solve is, who will benefit from the available novel anti-inflammatory approaches and when should this treatment be given?

NCT ID: NCT04903756 Active, not recruiting - Diabetes Mellitus Clinical Trials

PrEdiction of Risk and Communication of outcomE followIng Major Lower Limb Amputation - a collaboratiVE Study

PERCEIVE
Start date: October 1, 2020
Phase:
Study type: Observational

The PERCEIVE (PrEdiction of Risk and Communication of outcomE followIng major lower limb amputation - a collaboratiVE study) study aims to explore how decisions about major lower limb amputations are made by patients and healthcare professionals.

NCT ID: NCT04903106 Active, not recruiting - Meniscus Tear Clinical Trials

Safety and Performance Study of the FAST-FIX FLEX System for Meniscal Repairs and Meniscal Transplantations

FAST-FIX FLEX
Start date: January 20, 2022
Phase:
Study type: Observational

This study is a post-market follow-up study (PMCF). The data collected will serve the purpose of confirming the safety and performance of the FAST-FIX FLEX device, used according to the indicated for use (IFU) for meniscal repair and meniscal transplantations. Data will be collected on patients prior to surgery, at surgery and for 12 months after surgery.

NCT ID: NCT04902573 Active, not recruiting - Asthma Clinical Trials

A Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Out-comes

TriMaximize
Start date: June 17, 2021
Phase:
Study type: Observational

TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).

NCT ID: NCT04901728 Active, not recruiting - HIV Infections Clinical Trials

Patients' Experiences and Perceptions of 3TC/DTG Dual Therapy (the PEDAL Study)

PEDAL
Start date: July 1, 2021
Phase:
Study type: Observational

Improvements in health care and antiretroviral treatments have made it possible to turn HIV into a chronic disease leading to longer life expectancies and better quality of life among patients. Dual-drug combinations offer the advantage of a reduced exposure to antiretroviral agents, therefore leading to potential reductions in drug-associated side effects in the long-term. In light of this context, the primary aim of this qualitative study is to investigate patients' perceptions and experiences on the safety, effectiveness, tolerability, and unmet needs of the dolutegravir/lamivudine two-drug regimen. The secondary objective is to conduct a comparative analysis between patients on dolutegravir/lamivudine and patients on other two-drug and three-drug combinations. Lastly, the study aims to provide recommendations that improve doctor-patient communication, knowledge and understanding of the treatment plan, and additional care that ought to be considered in patient-centred, holistic care plans.