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NCT ID: NCT05093946 Recruiting - Clinical trials for Flexor Tendon Rupture

Psychometric Measurement Properties of the Michigan Hand Questionnaire in Patients After Flexor Tendon Repair

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

The aim of the study is to investigate the psychometric properties of the German Version of the Michigan Hand Questionnaire in patients with flexor tendon injuries, including reliability, validity and interpretability.

NCT ID: NCT05093088 Recruiting - Circadian Rhythm Clinical Trials

Effect of Circadian Rhythm on Brain NAD Measured by Phosphorus Magnetic Resonance Spectroscopy at 7 Tesla

ChronoBrain
Start date: September 1, 2021
Phase:
Study type: Observational

The Discovery of the circadian clock first established a genetic basis for behavior, and our understanding of circadian rhythm (CIR) has since expanded to provide molecular insights into physiology and disease. Yet the challenge remains to translate these insights regarding the role of the CIR in cells and tissues into the clinic. Many mechanistic pre-clinical experiments have shown that the CIR is directly linked with the Nicotinamide Adenine Dinucleotide (NAD) levels and the NAD redox ratio and that the NAD oscillation amplitude is diminished during aging and in the model of neurological diseases. Human ex-vivo data have also shown that NAD oscillates over time in human red blood cells. While mounting evidence in model organisms illustrate the central role of brain NAD for maintaining energy homeostasis and the CIR, similar data in human are sparse. To date, no study has been reported in human on the effect of the CIR on brain NAD levels. NAD is a vital cofactor involved in brain bioenergetics for metabolism and Adenosine Tri-Phosphate (ATP) production, the energy currency of the brain. NAD exists in an oxidized (NAD+) or reduced (NADH) form, with NAD+/NADH (the redox ratio) being an important determinant of cytosolic and mitochondrial metabolic homeostasis. Additionally, NAD+ is a key substrate for multiple NAD+-dependent enzymes and is consumed by at least four class of enzymes involved in genomic stability, mitochondrial homeostasis, adaptive stress responses, and cell survival, including Sirtuins. Modulation of subcellular NAD+ synthesis can regulate the timing of signaling pathways. Mammalian circadian rhythms are coordinated with metabolic activity through controlled expression of Nicotinamide phosphoribosyltransferase (NAMPT). Regulation of NAMPT, in turn, results in oscillating NAD+ levels. The rhythmic oscillation of NAD+ serves as a feedback 'timer' by modulating the activities of NAD+-dependent enzymes, including sirtuins, helping to establish the periodicity of the cycles. NAMPT oscillations also dictate mitochondrial NAD+ levels and coordinate cellular respiration with awake periods. In these cases, modulation of NAMPT levels drives the rise and fall of NAD+ concentrations that serve to limit the duration of Sirtuins activity. Fine control of neurometabolism is necessary for brain function, because neuronal firing produces dynamic changes in local energy demand. The Astrocyte Neuron Lactate Shuttle Hypothesis (ANLS) provides one way of understanding how these changing needs are met. In this model, neuronal activity increases extracellular glutamate, which stimulates increased glucose uptake and glycolysis in astrocytes. Within astrocytes, lactate is produced from pyruvate in a reversible manner by the lactate dehydrogenase enzyme in the cytoplasm. This enzyme requires NAD as a co-factor and one NADH is converted to NAD+ when one pyruvate molecule is converted to lactate. The astrocytes then release this lactate, increasing its extracellular concentration. Important to the ANLS hypothesis, lactate can be used by nearby neurons as an energy source. Furthermore, under the influence of the CIR regulation, the human psychological and physiological functions fluctuate with time during the day. This effect has been observed in many cognitive domains, as well as in risky decision-making and reward function. The hypothesis is that brain NAD level is modulated by the CIR and that the NAD redox ratio should increase during the day. The primary objective of this project is to determine the brain NAD status in the morning and in the afternoon. Many pre-clinical results have suggested a diurnal effect on brain NAD, yet no clinical data is available. In this study, NAD+ and NADH level of the occipital region will be determined by 31P-MR spectroscopy at 7 T. Total NAD (tNAD) and NAD redox ratio NAD+/NADH will be calculated as well. Measurement will be conducted in the morning in the fasted state (AM session) and in the mid-afternoon (PM session) 3 hours after the lunch intake. To confirm that the AM and PM measurements are done in two different circadian states, salivary cortisol will be measured. Simultaneous detection of other energy metabolites (e.g. lactate, PCr, ATP) will be acquired for exploratory analysis. To explore how the NAD status correlates with behavioral measures of reward activation, the automatic Balloon Analogue Risk Task (BART) test will be performed at the end of each AM and PM session.

NCT ID: NCT05092867 Completed - Clinical trials for Perioperative Complication

Reliability and Validity of a New Postoperative Track Assessment Tool

POTraTool
Start date: August 12, 2019
Phase:
Study type: Observational

This prospective observational study investigated the validity and reliability of a new postoperative track assessment tool. We hypothesized, first, that this tool estimates the indication and benefit of a management in an intermediate care unit (IMC). Second, we hypothesized that a) health care providers of IMC or postoperative anaesthesia care unit (PACU) have similar estimations using this tool and b) that this estimation is accurately established in the first 2 hours.

NCT ID: NCT05092737 Completed - Clinical trials for Sars-CoV-2 Infection

Physiological Response to Prone Position in COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS)

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

Retrospective study in COVID-19 ARDS patients hospitalised in the ICU. Investigators aim to explore the effects of prone positioning on oxygenation, dead space ventilation and mortality.

NCT ID: NCT05090878 Recruiting - Ischemic Stroke Clinical Trials

Atherogenic Lipoproteins in Ischemic Stroke

AGELESS
Start date: September 20, 2021
Phase:
Study type: Observational

Apolipoprotein B (apoB) levels (which encompass all atherogenic lipoproteins, including LDL), Lp(a) levels, and carotid IPH are associated with both first-ever and recurrent ischemic stroke. This cohort research project is to analyze: 1. Among patients with carotid artery atherosclerosis (stenosis 30-99%), to compare patients with and without IPH, as assessed by magnetic resonance (MR)-Plaque Imaging, in terms of apoB, Lp(a) levels and other cardiovascular risk factors. (IPH is a strong morphological sign of plaque vulnerability / instability and a strong marker of consecutive atheroembolic events). 2. Among patients with carotid artery atherosclerosis (stenosis 30-99%), to assess the risk of first-ever ischemic stroke in relation to apoB, Lp(a) levels, and presence of IPH, after adjusting for the cardiovascular factors (understanding this association can inform primary prevention). 3. Among patients with carotid artery atherosclerosis (stenosis 30-99%) with an ipsilateral ischemic stroke at baseline, to assess the risk of recurrent ipsilateral ischemic stroke in relation to apoB, Lp(a) levels, and presence of IPH, after adjusting for the cardiovascular factors. There will be a sensitivity analysis to assess if the association between Lp(a) and recurrent stroke is stronger in patients <60 years of age. (understanding this association can inform secondary prevention). For the first and second aim, there will be a cross-sectional, case-control analysis. For the third aim, i.e. assessing recurrent ischemic stroke, there is prospective follow-up of at least 3 months up to 45 months.

NCT ID: NCT05089487 Completed - Sleep Clinical Trials

Nocturnal Oxygenation and Sleep-related Breathing Disorders During the First Night of a Stay at 2500m of High Altitude in Patients With Precapillary Pulmonary Hypertension

Start date: October 18, 2021
Phase: N/A
Study type: Interventional

The impact of hypoxia at 2500m of high altitude on sleep in patients with precapillary pulmonary hypertension

NCT ID: NCT05088876 Recruiting - Pain Clinical Trials

Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control

ParOP
Start date: August 30, 2024
Phase: Phase 4
Study type: Interventional

Blinded withdrawal of regular co-medication with paracetamol in chronic pain patients under strong opioids on pain control.

NCT ID: NCT05086380 Recruiting - Clinical trials for Neurological Diseases or Conditions

Modulation of Sense of Agency With Non-invasive Brain Stimulation and Mindfulness-based Stress Reduction Therapy

Start date: December 10, 2021
Phase: N/A
Study type: Interventional

A conversion disorder is a dysfunction of the nervous system in which no structural damage can be demonstrated. However, it must be distinguished from other psychiatric disorders such as psychosis or depression. There are a variety of signs of the disease, such as muscle paralysis, uncontrolled tremors or cramps. In rarer cases, blindness, deafness or numbness may occur. Diagnosing this complex disorder has always been a challenge for neurologists and psychiatrists. This study investigates the effects of transcranial magnetic stimulation (TMS) on the general well-being and symptoms of conversion disorder and other neurological disorders and in comparison to healthy subjects. The TMS method allows to target specific areas of the brain by means of magnetic fields. This technique is not painful and does not have long-lasting effects. In addition, the study investigates the effects of mindfulness-based stress reduction on the general well-being and symptoms of conversion disorder and other neurological disorders and compared to healthy subjects. This technique is not painful and has no long-lasting effects. Furthermore, the study examines movement patterns and symptoms of patients compared to healthy controls while they are in a virtual reality. Finally, the study examines patients' brain activity while playing a game targeting the sense of agency in real time, which is recorded with an MRI scanner. The study includes a maximum of twelve sessions in total (ten sessions of approximately 1.5-2 hours each and two sessions each overnight). The planned study methods include TMS, (real-time and normal) magnetic resonance tomography of the brain (MRI "tube"), virtual- and augmented reality (AR/VR), questionnaires, blood, saliva, and motion sensors (e.g., fitness bracelet), and participation in the 8-week mindfulness program.

NCT ID: NCT05081661 Completed - Clinical trials for Anterior Cruciate Ligament Rupture

Effects of Corporal Visualisation Program of the Static and Dynamic Balance After an Operation of the LCA

Start date: March 8, 2022
Phase: N/A
Study type: Interventional

The aim of this pilot study is to assess the feasibility of a RCT whose topic would be the effect of a motor imagery program on the postural control in persons who have undergone ACL plasty.

NCT ID: NCT05081557 Recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess Real-World Use, Safety, and Effectiveness of Oral Upadacitinib in Adult and Adolescent (>=12 Years Old) Participants With Atopic Dermatitis

AD-VISE
Start date: November 17, 2021
Phase:
Study type: Observational

Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, important information is missing on the use patterns and outcomes with upadacitinib in a real-world setting. Therefore, the purpose of this observational study is to help inform real-world usage patterns regarding the safety and effectiveness and duration of response of upadacitinib in adolescent and adult AD participants >=12 years old in the real-world setting. Upadacitinib is an approved drug being developed for the treatment of AD. Around 975 adolescent and adult participants who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled worldwide. Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.