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NCT ID: NCT04834622 Recruiting - Clinical trials for Postnatal Depression

Community Singing Interventions for Postnatal Depression: a Hybrid Type II Effectiveness-implementation Trial

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

Postnatal depression (PND) affects over 13% of new mothers but there is still not an ideal treatment for all cases. Pharmaceutical and psychotherapy have offered solutions but there are challenges in treatment uptake and adherence and long waiting-lists for psychotherapy. Many mothers attend group activities with their babies, some including music and singing. Community group singing has shown improvement in mental health and singing to babies has shown improvement in mother-infant interaction and reduced infant distress. In this realm, Melodies for Mums (M4M) is a programme based in Lambeth and Southwark providing 10-week singing and music sessions for mothers with postnatal depression (PND) and their babies in community Children's Centres or online, according to government social distancing guidelines. Studies have demonstrated its effectiveness in reducing symptoms of PND faster than usual care or social groups, and preliminary process evaluations have suggested its suitability. It has also been identified as a strong way of engaging mothers from minority backgrounds who are less likely to seek professional support for their mental health. However, the programme is reliant on short-term grants and has not been implemented in clinical care. Therefore, there is a clear need to invest more research into this programme to help it achieve its potential. The investigators aim to conduct M4M in a clinical trial aimed at women experiencing symptoms of postnatal depression in the boroughs of Southwark, Lambeth and Lewisham. The investigators will collect data on the wellbeing of the women through a series of interviews and questionnaires and the investigators will also collect biological samples for stress and immunity markers from mothers and babies. In the long term the investigators intend to establish defined clinical referral pathways for patients from primary (GPs, community, among others) and secondary care (specialist doctor, hospital clinic) settings. In addition, the investigators will collect further evidence of the clinical, implementation and economic effectiveness of the intervention.

NCT ID: NCT04833894 Recruiting - Clinical trials for Generalized Myasthenia Gravis

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis

Start date: October 26, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG. Trial details include: - The maximum trial duration for each individual participant will be approximately 28 weeks - The treatment duration will be 8 weeks for the dose-confirmatory part (Part A) and 18 weeks for the treatment response-confirmatory part (Part B)

NCT ID: NCT04833114 Recruiting - Clinical trials for Refractory Diffuse Large B-Cell Lymphoma

Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) Versus R-ICE Alone in Second Line Treatment of Diffuse Large B-cell Lymphoma (DLBCL)

Pola-R-ICE
Start date: April 30, 2021
Phase: Phase 3
Study type: Interventional

An open-label, prospective Phase III clinical study to compare polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) with rituximab, ifosfamide, carboplatin and etoposide (R-ICE) alone as salvage therapy in patients with primary refractory or relapsed diffuse large B-cell lymphoma (DLBCL)

NCT ID: NCT04830592 Recruiting - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

A Study of NG-641 and Pembrolizumab in Squamous Cell Carcinoma of the Head and Neck

MOAT
Start date: November 4, 2021
Phase: Phase 1
Study type: Interventional

A multicentre, open-label, non-randomized, phase Ib neoadjuvant study of intravenous NG-641, as monotherapy or in combination with pembrolizumab, in patients with surgically resectable squamous cell carcinoma of the head and neck (SCCHN).

NCT ID: NCT04830124 Recruiting - Cutaneous Melanoma Clinical Trials

Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma - ARTISTRY-6

ARTISTRY-6
Start date: May 27, 2021
Phase: Phase 2
Study type: Interventional

This study observes the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy

NCT ID: NCT04829929 Recruiting - Clinical trials for Non-Valvular Atrial Fibrillation

Evaluation od Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk

Omega
Start date: November 17, 2020
Phase: N/A
Study type: Interventional

The purpose of the study is to assess the safety and performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in LAA (Left Atrial Appendage) closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk.

NCT ID: NCT04829825 Recruiting - Stroke Clinical Trials

The "MyoThrombus" Study

Start date: December 2, 2020
Phase:
Study type: Observational

Left ventricular thrombus is a recognised complication of acute myocardial infarction, associated with stroke, recurrent myocardial infarction and adverse cardiac remodelling. The prevention, treatment and resolution of thrombus is hampered by a lack of understanding of its initiation, propagation and dissolution. Advanced non-invasive imaging holds major promise in improving our understanding of the incidence and the natural history of left ventricular thrombus as well as providing potential biomarkers to assess disease activity and treatment efficacy. In this prospective observational study, the investigators will recruit patients with recent acute anterior myocardial infarction and screen them for evidence of left ventricular thrombus and subclinical stroke using hybrid positron emission tomography and magnetic resonance imaging (PET/MR). Each patient will undergo PET/MR of the heart and head 7±2 days after acute myocardial infarction. If left ventricular thrombus is present on baseline MR, patients will be started on anticoagulation at the discretion of the attending physician, who will determine the agent used (warfarin or direct oral anticoagulant) and the duration of therapy (3-6 months). Patients will then undergo repeat PET/MR at completion of anti-coagulant therapy and then again after another 3 months. Patients with increased 18F- GP1 activity but no overt thrombus on MR will undergo repeat PET/MR of the head and heart at 3 and 6 months to establish the natural history of this observation and its association with thromboembolism in the brain. They will not routinely receive anticoagulation given the exploratory nature of this study.

NCT ID: NCT04826159 Recruiting - Type 2 Diabetes Clinical Trials

IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)

Start date: April 21, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the activity of IMB-1018972 on cardiac energetic reserve at rest and during stress and to assess safety and tolerability

NCT ID: NCT04823663 Recruiting - Cardiac Disease Clinical Trials

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)

SOCRATES
Start date: March 31, 2021
Phase:
Study type: Observational [Patient Registry]

SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices' or short Medical Device Regulation (MDR). The SOCRATES design is therefore based on the BSC's commitment as well as external regulatory requirements to proactively and systematically gather, record and analyze relevant data on the quality, performance and safety of devices throughout their entire lifetime.

NCT ID: NCT04823559 Recruiting - Cancer Clinical Trials

The ThinkCancer! Feasibility Study

Start date: February 5, 2020
Phase: N/A
Study type: Interventional

Background Wales, like other UK countries, has relatively poor cancer outcomes. Late diagnosis and a slow referral process are major contributors. General practitioners (GPs) and other care providers working in primary care are often faced with patients presenting with a multitude of non-specific symptoms that could be cancer. Safety netting can be used to manage diagnostic uncertainty by ensuring patients with vague symptoms are appropriately monitored. The ThinkCancer! Workshop is an educational behaviour change intervention aimed at the whole general medical practice team, designed to improve primary care approaches to ensure timely diagnosis of cancer. The workshop will consist of teaching and awareness sessions, appointment of a Safety Netting Champion and the development of a bespoke Safety Netting Plan. This study aims to assess the feasibility of the ThinkCancer! Intervention for a future definitive randomised controlled trial, in terms of recruitment, randomisation, retention, acceptability, adherence and barriers to the intervention. Methods The ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and economic evaluation. Twenty-three to 30 general medical practices will be recruited across Wales, randomised in a ratio of 2:1 of intervention versus control who will follow usual care. The workshop will be delivered by a GP educator, and will be adapted iteratively throughout the trial period. Baseline practice characteristics will be collected via questionnaire. We will also collect Primary Care Interval (PCI), Two Week Wait (2WW) referral rate, conversion rate and detection rate at baseline and six months post-randomisation. Participant feedback, researcher reflective notes and economic costings will be collected following each workshop. A process evaluation will assess implementation using an adapted Normalisation Measure Development (NoMAD) questionnaire and qualitative interviews. An economic feasibility analysis will inform a future economic evaluation. Discussion This study will allow us to test and further develop a novel evidenced-based complex intervention aimed at general practice teams to expedite the diagnosis of cancer in primary care. The results from this feasibility study will inform the future design of a full-scale definitive phase III trial.