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NCT ID: NCT05146700 Active, not recruiting - Trauma Clinical Trials

Restrictive vs. Liberal Oxygen in Trauma

TRAUMOX2
Start date: December 10, 2021
Phase: Phase 4
Study type: Interventional

Victims of trauma are often healthy individuals prior to the incident, but acquire numerous complications including sepsis and pulmonary complications and diminished quality of life after trauma. According to Advanced Trauma Life Support guidelines, all severely injured trauma patients should receive supplemental oxygen. The objective of TRAUMOX2 is to compare the effect of a restrictive versus liberal oxygen strategy the first eight hours following trauma on the incidence of 30-day mortality and/or major respiratory complications (pneumonia and acute respiratory distress syndrome) within 30 days (combined primary endpoint).

NCT ID: NCT05145283 Recruiting - Clinical trials for Acute Ischemic Stroke

Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation

PAIR-TAVI
Start date: March 16, 2022
Phase: Phase 2
Study type: Interventional

The aim of this trial is to assess the safety and efficacy of conestat alfa (Ruconest®, Pharming Technologies B.V.) on renal and cerebral ischemic events in patients undergoing TAVI for severe symptomatic aortic stenosis (AS) compared to placebo.

NCT ID: NCT05144256 Active, not recruiting - Clinical trials for Pediatric Pyruvate Kinase Deficiency

A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Regularly Transfused, Followed by a 5-Year Extension Period

ACTIVATE-KidsT
Start date: June 8, 2022
Phase: Phase 3
Study type: Interventional

ACTIVATE-KidsT (AG348-C-022) is a multicenter study designed to evaluate the efficacy and safety of treatment with mitapivat compared with placebo in pediatric participants with pyruvate kinase deficiency (PK deficiency) who are regularly receiving blood transfusions. Participants will be randomized 2:1 to receive either mitapivat or matching placebo. Randomization will be stratified by age (1 to < 6 years, 6 to < 12 years, 12 to < 18 years) and splenectomy status. Participants will be dosed by age and weight during a double-blind period consisting of an 8-week dose titration period followed by a 24-week fixed-dose period. Participants who complete the double-blind period will be eligible to receive mitapivat for up to 5 years in the open-label extension (OLE) period.

NCT ID: NCT05143541 Completed - Thoracic Cancer Clinical Trials

Use of a New Stapling Device in General Thoracic Surgery

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

The goal of this study was to test the safety and efficacy of this stapler in our general thoracic surgery practice.

NCT ID: NCT05142137 Completed - Healthy Volunteers Clinical Trials

Novel Alpha Glucan GI Tolerability Study (Loris Chronic)

Start date: August 16, 2021
Phase: N/A
Study type: Interventional

This study aims to evaluate the gastrointestinal tolerance of chronic consumption (7 days) of a novel alpha glucan compared to a rapidly available carbohydrate (glucose syrup).

NCT ID: NCT05140577 Enrolling by invitation - Healthy People Clinical Trials

Reliability and Validity of the Evaluation of Hip Abductors Strength (RAVEHABDS)

RAVEHABDS
Start date: November 1, 2021
Phase:
Study type: Observational

The aim is to evaluate the intra- and inter-tester reliability, construct validity and feasibility of a new functional measurement procedure in a closed chain position on one leg. For this purpose, we will test the maximal voluntary isometric force, as well as the muscular contraction speed of the hip abductor muscles.

NCT ID: NCT05139732 Completed - Paralysis Clinical Trials

Exploring Functional Paralysis With Advanced Magnetic Resonance Modalities

Start date: November 4, 2022
Phase:
Study type: Observational [Patient Registry]

In functional neurological disorder (FND), neurological symptoms are present, such as paralysis, weakness and disturbed sensation of limbs, although clinically no abnormalities can be found. It is a poorly understood disorder with uncertain diagnosis, treatment and prognosis. In this study, the subtype functional paralysis is investigated with advanced neuroimaging techniques that go beyond standard clinical examinations. In previous research on FND, healthy volunteers have generally been used as a control group. However, since people with functional paralysis have similar symptoms to people with spinal cord injuries (SCI), it is intended to compare the three groups to find similarities and differences. With the proposed methods, the goal is to gain a detailed understanding of FND regarding nerve cell metabolism, diffusion pathways and neuronal networks involved in cognitive processes such as motor inhibition (reaction or no reaction depending on situation). Neurophysiological data, clinical assessments and questionnaires are carried out in addition to Magnetic Resonance Imaging (MRI). The aim is to enrol 75 participants in this study, i.e. 25 people with FND, 25 people with SCI and 25 healthy control subjects. The overall goal of the study is to find markers for FND for use in future studies to improve diagnosis and individualise therapy recommendation for both people with SCI and people with FND. Therefore, this study is a relevant step to understand FND and to diagnose this specific disease using objective MRI based diagnostic tools.

NCT ID: NCT05138679 Completed - Acute Limb Ischemia Clinical Trials

Evaluation of Acute Lower Limb Ischemia

PROMOTE-ALI
Start date: December 1, 2021
Phase:
Study type: Observational

The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acute lower limb ischemia (ALI). Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for revascularisation of affected limbs. Using an observational, international, multicentric study design (min. patient number of 500), the defined primary endpoint of the study, amputation-free survival 90 days after the diagnosis of ALI, will be evaluated.

NCT ID: NCT05137197 Recruiting - Clinical trials for Major Depressive Disorder

Confirm the Effectiveness of Predictix Genetics Antidepressant -Guided Treatment in Adults With MDD

Start date: October 4, 2021
Phase: N/A
Study type: Interventional

A randomized, controlled, prospective, multicenter, patient and rater blinded study with 2 arms: Treatment as Usual (TAU) and Predictix Guided Treatment (PGT). The study will compare the rate of treatment response and remission among both groups; TAU vs PGT.

NCT ID: NCT05136521 Completed - Healthy Clinical Trials

Bioavailability Study of 300 mg Trazodone Hydrochloride (New Polymer) vs. 300 mg Trazodone Hydrochloride (Contramid® Prolonged-release Tablets) Under Fasting Conditions

Start date: February 17, 2020
Phase: Phase 1
Study type: Interventional

This study was designed to investigate the bioequivalence of the test and reference products when administered as single oral doses in two consecutive study periods, under fasting conditions.