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NCT ID: NCT06175429 Recruiting - Frailty Clinical Trials

Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients

PREDICT
Start date: November 27, 2023
Phase:
Study type: Observational

The perioperative preservation of functionality and quality of life plays an increasingly important role in older physically limited and frail patients undergoing cardiac surgery. Hereby, impairments of the skeletal muscle system integrity often contributes to a reduced physical performance. Early identification of these high-risk patients could help to initiate appropriate preventive and therapeutic measures. Volatile organic compounds (VOC) represent a non-invasive and real-time measurable approach for recording physiological and pathophysiological processes. Isoprene (2-methyl-1,3-butadiene) is one of the most abundantly exhaled VOCs and has recently been shown to originate from skeletal muscle metabolism. However, the prognostic value of isoprene as a volatile biomarker for skeletal muscle integrity, physical performance and functional outcome in patients undergoing cardiac surgery has not been evaluated before.

NCT ID: NCT06172712 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A

CSA
Start date: May 8, 2024
Phase:
Study type: Observational

This work is a multicentric prospective cohort study designed to improve chronic obstructive pulmonary disease (COPD) treatment and management. The study involves 150 patients diagnosed with COPD who are at risk of exacerbations. These patients are recruited from three tertiary hospitals in Spain, Germany, and Italy. The study will last 18 months, with a 12-month follow-up duration for each patient. The primary objective of this study is to develop and test Artificial Intelligence (AI)-based models that can predict moderate-to-severe COPD exacerbations early on. This will be done by analyzing daily-life data collected from unobtrusive sensors that monitor patients' psycho-physiological and environmental signals. By accurately predicting exacerbations, the study aims to support clinicians in providing more precise, optimized, and personalized treatment to COPD patients. A secondary objective is to train and test AI-based models to estimate the 12-month dynamics of health-related quality of life (HRQoL) in COPD patients. This will involve analyzing data related to the patients' functional exercise capacity, dyspnea (difficulty breathing), and health-related quality of life, as measured by the Clinical COPD Questionnaire (CCQ) score and the COPD Assessment Test (CAT) score.

NCT ID: NCT06172088 Recruiting - Clinical trials for Breast Cancer Patients Treated With Aromatase Inhibitors

Exploratory Study Therapeutic Fasting Reduce Physical Limitations, Quality of Life During Aromatase Inhibitor Therapy

FREE-AI
Start date: December 15, 2023
Phase: N/A
Study type: Interventional

In this explorative study, the feasibility of therapeutic fasting to reduce limitations in physical well-being and quality of life of patients undergoing endocrine therapy with aromatase inhibitors will be investigated. In addition, the application of the StudyU app, which is currently under development, will be monitored and the app adapted if necessary. In addition, in preparation for a larger multicenter main study, it will be examined whether the muscle and joint complaints frequently experienced by patients undergoing endocrine therapy with aromatase inhibitors (AI) can be alleviated by a 7-day guided therapeutic fasting intervention (prolonged fasting / PF) can be improved.

NCT ID: NCT06171087 Recruiting - Emotions Clinical Trials

Emotions, Dopamine, Brain and Body

EMBODY
Start date: August 1, 2023
Phase: Phase 4
Study type: Interventional

The study will examine the influence of domperidon (20mg) on brain and hebavioral responses to emotional stimuli (videos) using fMRI

NCT ID: NCT06170905 Recruiting - Pregnancy Clinical Trials

Whey Protein Pre-load and Postprandial Glycemia in Pregnancy

ProGs
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

This pilot study aims to investigate the intake of whey protein prior to carbohydrate intake as an approach to modulate postprandial glucose excursions during pregnancy.

NCT ID: NCT06169982 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Multiple Dose Study of LY3209590 in Participants With Type 2 Diabetes

Start date: December 7, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to measure the activity and insulin time action of LY3209590 at steady state in participants with type 2 diabetes mellitus. The total study duration is approximately 182 days.

NCT ID: NCT06169956 Recruiting - Clinical trials for Resectable Non-small Cell Lung Cancer

An Observational Study to Evaluate Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy in Non-Metastatic Non-Small Cell Lung Cancer Participants in Germany

NENI
Start date: November 30, 2023
Phase:
Study type: Observational

The purpose of this observational study is to collect and evaluate real-world data to assess the effectiveness of neoadjuvant nivolumab when given in combination with platinum-based chemotherapy in participants with early-stage, resectable non-small cell lung cancer (NSCLC) in Germany

NCT ID: NCT06168799 Recruiting - Open Heart Surgery Clinical Trials

Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery

Start date: December 19, 2023
Phase: Phase 2
Study type: Interventional

The aim of this clinical trial is to evaluate the efficacy and safety of two intravenous administrations of ilofotase alfa in patients at risk for renal damage following open heart surgery.

NCT ID: NCT06168682 Active, not recruiting - Obesity Clinical Trials

Nasal CPAP - The Treatment IMpact on Oxygenation in High-risk Patients During Deep Sedation for Endoscopy

NAPTIME
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Deep sedation during gastrointestinal endoscopy in patients with cardiopulmonary risk factors such as respective co-morbidities or also morbid obesity is challenging. Those high-risk patients are at risk of upper airway obstruction and hypoxemia. Nasal continuous positive airway pressure may help to decrease the incidence of peri-interventional hypoxemia. However, data on nasal continuous positive airway pressure in high-risk patients having gastrointestinal endoscopy are scarce; only one randomized trial on gastroscopy in obese patients is available (Kang et al. J Anesth 2021). In a very high-risk group, namely patients assessed for heart or lung transplantation in our hospital, the risk was especially high (unpublished data). Aim of this trial is the effect of nasal continuous positive airway pressure - compared to nasal oxygen insufflation - on the incidence of hypoxemia in high-risk patients having gastrointestinal endoscopy in deep sedation. The investigators hypothesize that nasal continuous positive airway pressure - compared to nasal oxygen insufflation - reduces the incidence of hypoxemia in high-risk patients having gastrointestinal endoscopy in deep sedation.

NCT ID: NCT06168409 Recruiting - Clinical trials for Resistant Hypertension

A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension

Bax24
Start date: March 1, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and the effect of 2 mg Baxdrostat vs. placebo, administered QD orally, on the reduction of SBP, measured by average 24-hour ABPM in 212 participants with rHTN (defined as seated SBP ≥ 140 mmHg at Screening and mean ambulatory SBP ≥ 130 mmHg at baseline, despite a stable regimen of ≥ 3 antihypertensive agents, one of which is a diuretic).