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NCT ID: NCT05405426 Recruiting - Clinical trials for Extracorporeal Membrane Oxygenation

Trial of Indication-Based Transfusion of Red Blood Cells in ECMO

TITRE
Start date: April 14, 2023
Phase: N/A
Study type: Interventional

TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a multicenter, prospective, randomized clinical trial. The overarching goal of TITRE is to determine whether restricting red blood cell (RBC) transfusion according to an indication-based strategy for those with bleeding and/or deficit of tissue oxygen delivery, compared with transfusion based on center-specific hemoglobin or hematocrit thresholds, can reduce organ dysfunction and improve later neurodevelopment in critically ill children receiving Extracorporeal Membrane Oxygenation (ECMO) support.

NCT ID: NCT05405361 Recruiting - Clinical trials for Multifocal Motor Neuropathy (MMN)

A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy

ARDA+
Start date: January 18, 2023
Phase: Phase 2
Study type: Interventional

This trial is an extension of the antecedent trial ARGX-117-2002. It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ARGX-117 Intravenously (IV) in adults with Multifocal Motor Neuropathy (MMN). The trial will include a double-blinded rollover treatment period (DTP), an open-label treatment period (OTP), and a safety follow-up period.

NCT ID: NCT05405166 Active, not recruiting - Clinical trials for Plasma Cell Myeloma Recurrent

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

IRAKLIA
Start date: June 23, 2022
Phase: Phase 3
Study type: Interventional

This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

NCT ID: NCT05405114 Recruiting - Sickle Cell Disease Clinical Trials

Research Study Investigating How Well NDec Works in People With Sickle Cell Disease

ASCENT1
Start date: July 7, 2022
Phase: Phase 2
Study type: Interventional

This study examines how well a new, potential medicine called NDec works and is tolerated in people with sickle cell disease. NDec is a combination of two medicines (decitabine-tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease. Participants who are not taking Hydroxyurea (HU) will get NDec, NDec and placebo, or placebo. Participants who are on HU treatment before joining the study will get NDec, NDec and placebo, or continue on HU. Which treatment participants get is decided by chance. Participants getting NDec and/or Placebo will get capsules to take twice weekly. The study will last for about a year.

NCT ID: NCT05404932 Recruiting - Clinical trials for Plasminogen Deficiency

Treatment of Ligneous Conjunctivitis in Children With Plasminogen Deficiency

Start date: December 15, 2022
Phase: N/A
Study type: Interventional

Congenital plasminogen deficiency causes impaired wound healing and growth of pseudomembranous lesions over multiple parts of the body. The most common lesions involve eyes and are known as Ligneous conjunctivitis. These can cause scarring of the sclera, vision loss and even blindness. These pseudomembranous lesions are recur after surgical excisions, administration of intra-ocular cyclosporine, autologous serum drops or corticosteroids. Clinical data shows that these growths do not worsen and do not recur after administration of plasminogen (either as concentrate or as plasma) in the eyes, locally or intravenously. As plasminogen is not available as concentrate, we are using aliquoted allogenic plasma provided by Canadian Blood Services for intra-ocular application. These will be applied to eyes multiple times a day for a period of 2 to 6 months depending on disease severity and patient response. These may be used again if ligneous conjunctivitis recurs. The patient will be followed for a period of 2 years at least. All serious adverse events will be reported to Canadian Blood Services and Health Canada as appropriate.

NCT ID: NCT05404698 Completed - Clinical trials for Multimorbidity - End-stage Kidney Disease

Molecular and Clinical Response to a Single Bout of Aerobic Exercise in a Multimorbid Population: a Study From the Consortium on Precision EXercise in Aging

CPExA
Start date: June 20, 2022
Phase: N/A
Study type: Interventional

The combination of data from different origins (biological, health, patient-related) has the potential to improve care for the elderly. Precision approaches that are emerging in health are based on the premise that a better understanding of the biological responses to interventions will make it possible to optimize the treatments. In the field of exercise, this type of approach is emerging. This pilot study aims to collect preliminary data to demonstrate that a patient-centric vision with data from multiple sources is mandatory to personalize exercise intervention and improve health care. Older adults with end-stage chronic disease treated by hemodialysis represent a population of choice that requires personalized care since they are multimorbid and exhibit a complex health profile. On the other hand, the beneficial effects of exercise are still little understood and the avoidance of adverse effects in response to exercise such as hypotension during dialysis remains uninvestigated.Objective: Demonstrate the feasibility of an integrative approach by combining "omics", clinical data, patient-related outcomes (PRO) as well as exercise variables (e.g., intensity, duration) Methods: A total of 10 people aged 60 and over will be recruited to randomly perform 2 experimental conditions: hemodialysis alone (CONT) or hemodialysis + aerobic exercise (EX), which will be carried out over 2 visits one week apart. These visits will take place at the scheduled time of the hemodialysis treatment. The variables of interest are: blood pressure response to a single bout of exercise exercise (during and post-exercise), symptoms (with visual analogue scales within 36 hours of the visit + Dialysis symptom index for the 7 days after the experimental visit), dialysis efficiency (Kt/V) and biological response (proteomics and metabolomics). Health-related quality of life (KDQOL questionnaire), medical data (electronic medical record), and level of physical activity (PASE questionnaire and smart watch; Apple Watch) will be evaluated.

NCT ID: NCT05404633 Recruiting - Clinical trials for End-stage Renal Disease

Usefulness and Acceptability of a Connected Ergocycle for the Elderly in a Clinical Setting

Start date: August 31, 2021
Phase: N/A
Study type: Interventional

Hospitalizations are harmful to patients. Without a proper intervention, it will lead to a permanent decline in physical function, especially among frail individuals. Ultimately, this will worsen quality of life, as well as the cognitive and functional status of affected elderly people, which will arguably reduce functional independence, increase post-discharge institutionalization and death among frail older adults. It is known that patients receiving early physical evaluation and rehabilitation (in the 24 hours following admission) improves post-discharge orientation, decreases delirium and the need of acute care. The rehabilitation often involves ergocycles, but commercially available devices are expensive and often hard to move, to set up in hospital bed and lack connectivity. In this context, a connected ergocycle prototype which has a number of desired characteristics, including low production cost, relatively light and easy to move and with internet connectivity. The goal of this study is thereby to assess the usefulness and acceptability of the prototype with health professionals involved in physical rehabilitation and patients receiving said rehabilitation.

NCT ID: NCT05404204 Recruiting - Clinical trials for Coronary Artery Disease

The Efficacy and Safety of a Novel Adjunctive Pacing Strategy During Rotational Atherectomy

ROTA-PACE
Start date: February 1, 2021
Phase:
Study type: Observational

Coronary artery narrowings interfere with blood flow to the heart which can cause chest pain and heart attacks. Cardiologists can treat these narrowings with balloons and stents. However, some narrowings can become very calcified and hard making treatment with balloons and stents difficult. Rotational atherectomy is a tool to treat calcific coronary disease. It uses an ablative drill to break down the hardened plaques inside the coronary arteries facilitating subsequent treatment with balloons and stents. However, during this procedure patients can experience a slow heart rate which may compromise procedural safety. Cardiologists may use a temporary pacemaker that is inserted by separately accessing the heart through a large vein usually from the leg. This maintains a safe heart rate throughout the procedure. However, inserting the temporary pacemaker is associated with additional complications. We have developed and propose an alternative strategy to provide a temporary safety pacemaker during rotational atherectomy without the need for inserting an additional pacemaker.

NCT ID: NCT05404139 Active, not recruiting - Clinical trials for Metastatic Prostate Cancer

Duration of Enzalutamide and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)

Start date: May 24, 2023
Phase: Phase 2
Study type: Interventional

This is a multi-centre, investigator-initiated, two-arm, randomized trial to investigate the addition on enzalutamide to standard of care radiation and hormone therapy improve quality of life. Participants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1) or standard of care radiation and hormone (ADT) therapy plus oral enzalutamide for 8 months (Arm 2). Participants will be routinely follow-up in clinic or remotely for up to 5 years.

NCT ID: NCT05403983 Completed - Pregnancy Related Clinical Trials

Effectiveness of a 12-week Movement Intervention on Heart Rate Variability and Self-compassion Among New Mothers

MOM-mi
Start date: August 15, 2022
Phase: N/A
Study type: Interventional

This is a mixed-methods randomized controlled trial assessing the effects of an online and in person 12-week movement intervention compared to an education only control group on heart rate variability, self-compassion, psychological well-being, fatigue, exercise self-efficacy, physical activity identity, and body image in postpartum women.