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NCT ID: NCT04790370 Recruiting - Pulmonary Embolism Clinical Trials

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism

HI-PEITHO
Start date: August 2, 2021
Phase: Phase 4
Study type: Interventional

There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.

NCT ID: NCT04783584 Recruiting - Clinical trials for Difficult Intubation

Agreement Between Video and In-person Airway Assessment Performed by Anaesthetists in Patients Scheduled for Elective Same-day Gynaecological Procedures

Start date: December 1, 2020
Phase:
Study type: Observational

During a general anaesthetic, patients cannot breathe on their own and have to be artificially ventilated. This is achieved by connecting the patient's windpipe (trachea) to a ventilator via the use of a plastic tube called an endotracheal tube (ETT). To place this ETT into the patient's trachea, an instrument called a laryngoscope is used to lift the tongue and view the entrance to the trachea. This process is called laryngoscopy. The act of placing this ETT into the trachea is called intubation. In anticipation of this procedure, the airway is assessed by the anaesthetist before the patient is put to sleep. This airway examination helps predict if the patient's airway will prove to be difficult to intubate. This assessment is usually carried out face to face with the patient. Since the onset of the COVID 19 pandemic, we have been trying to minimise patient footfall performing anaesthetic assessments before surgery through a video platform. The objective of this study is to compare these video airway evaluations to assessments carried out face to face. We anticipate that the virtual airway assessments will be similar if not the same as the in-person airway assessments.

NCT ID: NCT04783298 Recruiting - Clinical trials for Lifestyle, Sedentary

Can Methods From Computational Psychology be Used to Phenotype Individuals Most Likely to be Non-adherent to Fitness Goals?

Start date: January 1, 2021
Phase:
Study type: Observational

This is a longitudinal study combining objective sensor data, with decision-making games and contextual personality traits to identify patterns in exercise decay. The data generated will be used to build computational models to predict digital personas, and help identify those individuals most likely to abandon exercise goals.

NCT ID: NCT04768972 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic Lateral Sclerosis Participants With Fused in Sarcoma Mutations (FUS-ALS)

Start date: June 14, 2021
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of ION363 on clinical function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral sclerosis (FUS-ALS).

NCT ID: NCT04761484 Recruiting - Clinical trials for Preterm Birth Complication

Umbilical or Peripheral Catheter Insertion for Preterm Infants on Admission to the NICU

UP
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Preterm infants are at risk of hypothermia following delivery and in the first few hours of life. Hypothermia in extremely low birth weight infants' is an independent risk factor for death. These infants' are at additional risk of hypothermia when they undergo procedures such as central catheter insertion following admission. The investigators think that in extremely preterm infants, placing a peripheral intravenous cannula on admission to the NICU, instead of umbilical catheters (UVC and/or UAC), will increase the proportion of infants with a rectal temperature in the normal range at 2 hours of life.

NCT ID: NCT04750798 Recruiting - Cardiac Arrhythmias Clinical Trials

An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias

Start date: February 22, 2021
Phase:
Study type: Observational

The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.

NCT ID: NCT04750161 Recruiting - Atopic Dermatitis Clinical Trials

The Role Of Neutrophil Proteases As Global Regulators Of Il-1 Family Cytokine Activity In Skin Disorders

NEUTROPRO
Start date: March 2, 2021
Phase:
Study type: Observational

Pro-inflammatory cytokines are critically important drivers of inflammatory and autoimmune diseases and cytokine-targeted biologics have been transformative in the treatment of several inflammatory and autoimmune diseases. As the diversity of approved cytokine-targeted biologic therapies grows, it will become increasingly important to stratify patients on the basis of specific genetic or disease biomarker phenotypes to ensure that patients receive the appropriate cytokine-targeted biologic, at the appropriate dose, and at the appropriate time. This project aims to explore patterns of pro-inflammatory cytokine/chemokine expression within normal versus (i) psoriatic, (ii) eczematic, (iii) ichthyotic human skin, as well as in human and mouse models of skin inflammation, with the objective of identifying cytokine response profiles ('cytokine fingerprints') that will provide a molecular basis for (a) the stratification of patients into disease subtypes that (b) enable cytokine-directed biologics to be targeted towards patients that are most likely to benefit from them. The investigators anticipate that 'cytokine fingerprinting' will aid in the selection of the most appropriate biologics in patients that are most likely to benefit from such therapies.

NCT ID: NCT04728893 Recruiting - Clinical trials for Hematologic Malignancies

Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

Start date: April 5, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).

NCT ID: NCT04723836 Recruiting - Pregnancy Clinical Trials

Optimal Nutrition for Prevention of Hypertension in Pregnancy

OptiPREG
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the role of the 677C→T polymorphism in the methylenetetrahydrofolate reductase (MTHFR) gene on blood pressure (BP) during pregnancy, and to examine the effect of intervention with riboflavin, alone or in combination with 5-methyltetrahydrofolate (5-MTHF), as a non-drug approach for managing BP in pregnancy in women with the variant TT genotype. In addition, we aim to examine the effect of maternal supplementation with riboflavin, alone or combined with 5-MTHF, on BP in the offspring in early infancy. Study design: A double-blind randomized controlled trial in pregnant women will be conducted. Women with a singleton pregnancy who are in their first trimester will be recruited from antenatal clinics in Northern Ireland and the Republic of Ireland. Women interested in the study will provide informed consent, complete a screening questionnaire and will provide a buccal swab to collect DNA to screen for the MTHFR 677C→T polymorphism. Women with multiple pregnancies, a previous NTD-affected pregnancy and those who are taking medication interfering with B-vitamin metabolism will be excluded from participation in the study. At approximately the 16th gestational week (GW), those with the variant TT genotype and age-matched heterozygous women (CT genotype) will be randomised to receive riboflavin (5 mg/day) alone, or in combination with 5-MTHF (400µg/day), or placebo, until the end of pregnancy. A non-fasting blood sample will be collected for biomarker assessment of B-vitamin status and other relevant variables from each participant before intervention and at the 36th GW. At the same time points, anthropometric and BP measurements will be taken. Women will also complete a health and lifestyle questionnaire and a 4-day dietary record. Samples of cord blood, umbilical cord and placenta will be collected after delivery and anthropometric parameters of the newborns will be retrieved postpartum. Maternal and infant BP will be measured 2-4 months after birth. In parallel with the intervention trial, age-matched pregnant women who do not carry the variant gene (CC genotype) and have not been randomized to treatment, will be monitored in order to control for any changes associated with normal pregnancy in the study outcome measurements. In the pilot phase, the feasibility and acceptability of the study procedures and treatment will be evaluated for clarification of the sample size and refinement of the study protocol.

NCT ID: NCT04718389 Recruiting - Asthma Clinical Trials

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype

NIMBLE
Start date: January 26, 2021
Phase: Phase 3
Study type: Interventional

This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.