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NCT ID: NCT06245694 Recruiting - Clinical trials for Artificial Intelligence

Predictive and Advanced Analytics in Emergency Medicine - Neurological Deficits

PAN-EM-NEURO
Start date: January 1, 2022
Phase:
Study type: Observational

Future predictive modeling in emergency medicine will likely combine the use of a wide range of data points such as continuous documentation, monitoring using wearables, imaging, biomarkers, and real-time administrative data from all health care providers involved. Subsequent extensive data sets could feed advanced deep learning and neural network algorithms to accurately predict the risk of specific health conditions. Moreover, predictive analytics steers towards the development of clinical pathways that are adaptive and continuously updated, and in which healthcare decision-making is supported by sophisticated algorithms to provide the best course of action effectively and safely. The potential for predictive analytics to revolutionize many aspects of healthcare seems clear in the horizon. Information on the use in emergency medicine is scarce. Aim of the study is to evaluate the performance of using routine-data to predict resource usage in emergency medicine using the commonly encountered symptom of acute neurologic deficit. As an outlook, this might serve as a prototype for other, similar projects using routine medical data for predictive analytics in emergency medicine.

NCT ID: NCT06245681 Recruiting - Gender Dysphoria Clinical Trials

Effects of Cross-sex Hormone Treatment on Cardiac Function, Myocardial and Hepatic Fat Content

Start date: October 20, 2017
Phase:
Study type: Observational

Background: Sex hormones are believed to play an important role in the development and progression of cardiovascular disease. However, the gender gap in onset and mortality is not yet completely understood. Transsexuals undergoing hormone therapy are a promising collective for analyzing the effects of sex hormones on atherosclerosis and other cardiovascular disease. Objectives of the study: To identify gender-specific cardiovascular changes attributed to high-dose hormone therapy in male-to-female (MtF) and female-to-male(FtM) transgender using sonography and magnet resonance spectroscopy. Study design: Longitudinal cohort study. Transsexuals will undergo two 3 Tesla MRI scan sessions: 1. baseline (before hormone treatment) and 2. after 6 months of treatment. An oral glucose tolerance test (OGTT) will be performed at baseline and 6 months after treatment onset. We propose an overall study duration of 12 months. Materials and Methods: MRI measurements will be performed on a 3 Tesla scanner. Study population: 10 FtM, 10 male-to-female MtF transsexuals (aged 18-50), free of hormone-medication at baseline. Relevance and implications of the study: Changes in atherosclerotic risk due to hormone therapy have been studied to no definite results and so far, little is known about the effects of hormone therapy on hepatic and myocardial fatty tissue. Hence this study will provide important new data on the broad clinical aspects of sex hormones as hormone replacement therapy in particularly opposite-sex hormone therapy.

NCT ID: NCT06237803 Recruiting - Multiple Myeloma Clinical Trials

European Myeloma Network (EMN) Sample Project

EMN36
Start date: December 21, 2022
Phase:
Study type: Observational

This is an observational, non-interventional, multicenter study for the prospective collection, storage and analysis of patients' biological samples. This study establishes a common international infrastructure useful to collect standard clinical variables at baseline and during treatment and to uniformly collect and store biological samples

NCT ID: NCT06223789 Recruiting - Atrial Fibrillation Clinical Trials

VOLT-AF IDE Clinical Study

Start date: April 3, 2024
Phase: N/A
Study type: Interventional

This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

NCT ID: NCT06222463 Recruiting - Clinical trials for Mechanical Ventilation

Power Dissipation in Flow-controlled Ventilation

POWER-FLOW
Start date: January 31, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized clinical cross-over trial is to compare power dissipation (Pd) during flow-controlled ventilation with either standard of low tidal volume ventilation or compliance guided individualization of ventilator settings. This study is performed in patients scheduled for open abdominal surgery and the primary and secondary outcome parameters are: - power dissipation [J/min] during ventilation calculated by integrating the hysteresis of the tracheal pressure-volume loop - applied mechanical power during ventilation calculated by published formulas [1] - oxygenation of the blood assessed by PaO2/FiO2 ratio - decarboxylation assessed by required respiratory minute volume to maintain normocapnia - comparison of respiratory variables in low tidal volume versus individualized ventilation Participants will randomly receive either low tidal volume (LTV) or individualized flow-controlled ventilation [2]. In the LTV group, the positive end-expiratory pressure will be set to 5 cmH2O and the peak pressure set to achieve a tidal volume of 7 ml/kg predicted body weight. In the individualized group positive end-expiratory and peak pressure will be titrated to achieve the highest compliance [2]. In both groups the flow will be set to achieve normocapnia (PaCO2 35-45 mmHg). After obtaining three consecutive measurements the ventilation strategy will be switched to the alternative regime in a cross-over design and again, three measurements recorded. The investigators hypothesize, that individualized ventilator settings are able to improve ventilation efficiency in terms of a lower required minute volume to maintain normocapnia and thus is able to reduce power dissipation during ventilation. Secondary endpoint will be a comparison of Pd to calculated mechanical power, as a currently accepted surrogate parameter for ventilation invasiveness [2] and also outcome predictor. Additionally, gas exchange parameters such as oxygenation and decarboxylation will be compared between low tidal volume and individualized ventilation.

NCT ID: NCT06220188 Recruiting - Clinical trials for Prostate Cancer Recurrent

PSMA-RLT in Biochemically Recurrent PCa

Start date: January 15, 2024
Phase: Phase 2
Study type: Interventional

Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical prostatectomy (RP) or PSA > nadir + 2ng/ml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.

NCT ID: NCT06212999 Recruiting - Clinical trials for Hidradenitis Suppurativa (HS)

A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

STOP-HS LTE
Start date: January 30, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 [NCT05620823] or INCB 54707-302 [NCT05620836]).

NCT ID: NCT06212427 Recruiting - Premature Infant Clinical Trials

Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)

Start date: November 20, 2023
Phase: N/A
Study type: Interventional

The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose [2'FL] and lacto-N-neotetraose [LNnT], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.

NCT ID: NCT06211049 Recruiting - Clinical trials for Primary Dysmenorrhea

Efficacy of Vitex Agnus-castus BNO 1095 (20 mg) in Women With Primary Dysmenorrhea

Start date: December 12, 2023
Phase: Phase 3
Study type: Interventional

In this Phase III study, the herbal product Vitex agnus-castus BNO 1095 20 mg will be tested. The sponsor would like to find out if treatment with Vitex agnus-castus BNO 1095 20 mg may improve the cramping pain before or during menstruation (primary dysmenorrhea) (without an organic cause) in women and if this treatment is safe. It is tested, if the pelvic pain and other symptoms during menstruation improve in patients who are treated with Vitex agnus-castus BNO 1095 20 mg and if therefore the standard treatments for primary dysmenorrhea, for example pain relief medications will not have to be increased. The study has 2 treatment groups. Patients in one group will receive Vitex agnus-castus BNO 1095 20 mg, and patients in the other group will receive a placebo. Placebo tablets look like Vitex agnus-castus BNO 1095 20 mg tablets but have no active ingredient. Patients will be randomly assigned (like tossing a coin) to one of the 2 groups (this process is called randomization). The chance for the patients to receive Vitex agnus-castus BNO 1095 is 50%. Neither the patients nor the investigators know which product the patients are taking (this method is known as "double-blind").

NCT ID: NCT06201650 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Neurofilament Light Chain in Amyotrophic Lateral Sclerosis

NfL-ALS
Start date: November 11, 2020
Phase:
Study type: Observational

This study assesses the performance of serum neurofilament light chain (sNfL) in amyotrophic lateral sclerosis (ALS) in a wide range of disease courses, in terms of ALS progression, disease duration, and tracheostomy invasive ventilation (TIV). The aim of the research project is to investigate the correlation between NfL serum concentration and the natural course of the disease, the ALS progression rate, and specific phenotypes of ALS. Furthermore, the performance of NfL as a therapeutic biomarker will be studied. A systematic analysis of the NfL serum concentration in a cohort of 3,000 ALS patients using the Single Molecule Analysis method (SIMOA) will be performed. This analysis is carried out as a multi-center study.