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NCT ID: NCT04077294 Completed - Myocardial Injury Clinical Trials

Preoperative BNP: Epidemiological Patterns, Management Strategies and Cost Analysis of Care

Start date: May 21, 2019
Phase:
Study type: Observational

Recently, the use of preoperative BNP as a preoperative risk stratifcation tool was added to the Canadian Cardiovascular Society (CCS) guidelines (4) on perioperative cardiac risk assessment and management for patients who undergo noncardiac surgery, based on the prognostic value of preoperative BNP in indentifiy patients at significant risk of 30-day mortality, nonfatal myocardial infarction, or myocardial injury after noncardiac surgery (MINS). While the value of screening for high risk patients through the use of preoperative BNP been demonstrated, the management of postoperative ischemia is less clear. Therefore, this study aims to: 1. Evaluation of the use of BNP as a preoperative screening biomarker; how often is it ordered in Anesthesia Preadmission Clinic and what is the incidence of a positive result (BNP ≥ 92 ng/L) 2. Determine the incidence of myocardial injury after non-cardiac surgery (MINS) at 30 days and myocardial infarction at 1 year at a tertiary care center when BNP is used as a screening tool 3. Record patterns of management of patients with MINS 4. Determine the cost associated with the different patterns of management of MINS 5. Comparison with a cohort group who qualified for BNP screening according to CCS guidelines but did not have it measured. The investigators will attempt to evaluate the cohort group for MINS at 30 days and myocardial infarction at 1 year.

NCT ID: NCT04076501 Completed - Clinical trials for Grown-up Congenital Heart Disease (GUCH)

Effect of Short-term Oxygen During CPET in GUCH

Start date: September 12, 2019
Phase: N/A
Study type: Interventional

In a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with grown-up congenital heart disease.

NCT ID: NCT04075812 Completed - Clinical trials for Spinal Cord Injury at C4-C6 Level

High Definition Neuromuscular Stimulation in Tetraplegia

Start date: April 25, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate high definition non-invasive neuromuscular stimulation of an upper extremity in tetraplegic participants.

NCT ID: NCT04075448 Completed - Cognitive Change Clinical Trials

The Acute Effect of a Walnut Intervention on Cognitive Performance, Brain Activation, and Serum Markers of Inflammation in Young Adults

WalCog
Start date: November 8, 2019
Phase: N/A
Study type: Interventional

This study investigates the effect of acute walnut consumption on the cognitive behaviour, mood, brain activation, and markers of inflammation in young adults. In a within subjects design participants will receive a 50 g walnut or placebo intervention in a randomised order with a one week washout between interventions.

NCT ID: NCT04075123 Completed - Clinical trials for Respiratory Insufficiency Syndrome of Newborn

CPAP vs NIPPV: A COMPARATIVE EFFECTIVENESS RESEARCH

Start date: October 1, 2019
Phase:
Study type: Observational [Patient Registry]

Aim: Investigators aim is to conduct two complementary and concurrent CER projects using a pragmatic clinical trial design and registry-based RWD to identify the optimal respiratory management practices for extremely preterm neonates and reduce the risk of BPD and SNI. Objectives: Two complementary objectives are proposed. Objective 1: To determine the efficacy and safety of "mandatory non-extubation" until 72 hours of postnatal age for preterm neonates born at 23 -25 weeks' GA who receive mechanical ventilation. Objective 2: To determine whether optimal nasal continuous positive airway pressure post-extubation is as efficacious as nasal intermittent positive pressure ventilation in preterm neonates born at 23 -28 weeks' GA who have received mechanical ventilation.

NCT ID: NCT04075110 Completed - Clinical trials for Obesity; Endocrine; Diabetes Type 2

Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus

Start date: July 1, 2019
Phase: Early Phase 1
Study type: Interventional

The aim of the current study is to evaluate the safety and efficacy of Montelukast in treatment of obese patients with type 2 diabetes (T2DM).

NCT ID: NCT04074980 Completed - Clinical trials for Anticoagulants and Bleeding Disorders

Evaluation of the Accuracy of INR Results From Patients Taking Phenprocoumon as Anticoagulant When Measured Using the Lumiradx INR Test

VKA GERMANY
Start date: May 9, 2019
Phase: N/A
Study type: Interventional

This study is to evaluate the INR levels in patients taking phenprocoumon using the LumiraDx Point of Care INR test and comparing the results to the laboratory reference method , the ACL Elite Pro. Comparison will also be made with the Roche Coaguchek point of care INR test (point of care reference method). Performance will be demonstrated across a subject population of adult males and females in receipt of Phenprocoumon VKA therapy. This population is representative of the indications for use of the CE marked product. Operators will be trained clinical site staff. Venous plasma and capillary whole blood samples will be obtained from each subject in order to assess accuracy of the the LumiraDx Platform when compared to the reference devices (ACL Elite and Coaguchek Pro).

NCT ID: NCT04074317 Completed - Clinical trials for Diabetes Mellitus, Type 1

Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D

Start date: August 22, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, active-controlled, single-dose, 3-treatment, 3-period, 3-way crossover, comparative PD and PK inpatient study in adults with T1D. The study comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up (Visit 5).

NCT ID: NCT04074187 Completed - Clinical trials for Thrombotic Thrombocytopenic Purpura

A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

Start date: October 21, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objective: To evaluate the effect of caplacizumab on prevention of recurrence of aTTP (proportion of participants with a recurrence of aTTP) during the overall study period. Secondary Objectives: - To evaluate effect of caplacizumab on - prevention of recurrence of TTP (the number of recurrences of TTP) during overall study period. - a composite endpoint consisting of aTTP-related mortality, recurrence of aTTP and major thromboembolic events during study drug treatment - restoring platelet counts as a measure of prevention of further microvascular thrombosis - refractory disease - biomarkers of organ damage: LDH, cardiac troponin I, serum creatinine - plasma exchange (PE) parameters (days of PE and volume of plasma used), days in intensive care unit, days in hospital - cognitive status of Japanese patients - To evaluate safety profile of caplacizumab in Japanese patients - To evaluate effect of caplacizumab on pharmacodynamic (PD) markers in Japanese patients - To evaluate pharmacokinetic (PK) profile of caplacizumab in Japanese patients - To evaluate immunogenicity of caplacizumab in Japanese patients

NCT ID: NCT04073862 Completed - Depressive Symptoms Clinical Trials

The Norwegian Stepped-Care TF-CBT Study

Start date: May 13, 2019
Phase: N/A
Study type: Interventional

Every day, a significant number of children and young people in Norway experience violence, abuse, or other potentially traumatizing events. These children are at risk of developing serious health problems such as post-traumatic stress disorder (PTSD), anxiety, depression, behavioral problems, and drug dependency. Moreover, when left unaddressed, trauma experiences in childhood can have long-term implications for work- and educational participation as well as later subjection to violence. Provision of accessible and situationally adaptable treatments can therefore have great benefits for children, families, and communities at large. In this project, the investigators will introduce the method of Stepped-Care Trauma-Focused Behavioral Cognitive Therapy (SC-TF-CBT) in a selection of 15 municipalities across Norway. SC-TF-CBT is a parent-led - therapist-assisted low-threshold method aimed at treating children exposed to abuse, sexual assault, or other trauma and who are at risk of developing more severe trauma-related difficulties (Salloum, et al. 2014). This is the first test of the method outside the US. The project's main aim is therefore to evaluate the feasibility and efficiency of the treatment in a Norwegian context through a pre-post design. The following questions are to be explored: 1. How does the SC-TF-CBT model fit the Norwegian health care culture and service system? 2. When testing Stepped-Care in a Norwegian context, the model is set to involve both the municipal and specialist service levels. Severe cases will be stepped up/transferred to the specialist level for TF-CBT treatment. How do these transitions work for the participating families, and what are the experiences and perspectives of practitioners and service-leaders regarding coordination and collaboration between service levels? 3. Do the children, parents, and therapists like working with the method? 4. Do recipients of the treatment (children and parents) report symptom improvement? 5. Which children and parents seem to benefit the most from the method, and who do not?