Clinical Research Directory

Reducing Heart Failure Risk in Late-Life With Physical Activity

The goal of this clinical trial is to learn about the molecular pathways associated with the benefit of a regular exercise program in patients with high blood pressure and who don't already participate in regular exercise. The main question it aims to answer is to identify protein signatures associated with the benefits of a cardiac rehabilitation exercise program. The trial will enroll 42 participants, who will be randomized to a 12 week cardiac rehabilitation exercise program versus control arm and asked to participate in the following at the beginning and end of study: * Cardiopulmonary exercise test (CPET) * Echocardiogram * Physical function test * 6-minute walk test * Hand grip strength * Quality of life questionnaire * Blood draws Researchers will compare results between those who do and don't participate in the exercise program.

EPIGUT: EPILEPSY AND GASTROINTESTINAL MICROBIOTA: UNDERSTANDING THERAPY RESPONSE

The goal of this observational study is to learn how the bacteria in the gut and mouth (called the microbiota) are linked to different types of epilepsy and how they may affect how well seizure medicines work. Researchers want to answer two main questions: Are certain types of epilepsy linked to changes in the gut or mouth microbiota? Do the bacteria in the gut change how seizure medicines work for each person? Epilepsy is a brain condition that causes seizures. Even though there are many medicines for epilepsy, some people still have seizures or side effects. Studies in animals show that gut bacteria can raise or lower the chance of seizures. Smaller studies in people suggest the same thing, but they have been limited in size and scope. In this study, researchers will collect biological samples from people who have newly diagnosed epilepsy and from people without epilepsy (called healthy controls). The samples will be tested to learn which bacteria are present. The researchers will then look for patterns that may explain which types of epilepsy are linked to changes in the microbiota. The study will also look at whether the bacteria in the gut and mouth affect how well anti-seizure medicines (ASMs) work. For example, the researchers will explore if certain bacteria make medicines work better or worse. Patients will provide blood, stool and saliva samples. If collected for medical reasons, cerebrospinal fluid (CSF) - the clear liquid that surrounds the brain and spinal cord -will also be used. Healthy controls will provide stool and saliva samples only All participants will be asked to fill an online questionnaire to share health and lifestyle information. Patients also allow researchers to confidentially access data from medical records related to diagnosis and treatment. By comparing data from many participants across Sweden, researchers hope to understand how gut and mouth bacteria influence epilepsy and seizure control. This research may help doctors in the future to use a person's microbiota profile to choose the best seizure medicine. The long-term goal is to improve seizure control, reduce side effects, and raise the quality of life for people living with epilepsy.

Using 4D Urinary Proteomics to Predict and Evaluate Treatment Response in Colorectal Cancer

The goal of this observational study is to learn how well urinary proteins can predict treatment response in patients with locally advanced colorectal cancer (LACC) undergoing neoadjuvant therapy. The main question it aims to answer is: Can urinary protein markers help predict and evaluate how patients with LACC respond to neoadjuvant therapy? Participants diagnosed with LACC will provide urine samples before and after neoadjuvant therapy. These samples will be analyzed using 4D deep urinary proteomics and machine learning to identify proteins linked to treatment response. Some participants' tumor tissues will also be used to create organoid models for further testing.

Proteomic Analysis of Serum Samples After Cardiac Arrest: a TTM-trial Substudy

Cardiac arrest remains a large contributor to morbidity and mortality. Animal studies suggest an improvement in mortality and neurological function with hypothermia after cardiac arrest, a finding that could not be verified in large clinical trials such as Target Temperature Management after Out-of-hospital Cardiac arrest (TTM) trial. Multimodal neuroprognostication is an important tool for differentiating patients that will recover after cardiac arrest, and currently only one biomarker is in clinical use. The purpose of this study is to explore proteomics profiles in TTM trial patients in order to search for potential novel biomarkers, therapeutic targets, and to explore phenotypes of post-cardiac arrest syndrome.

Cohort-Based Study of Diagnostic Biomarkers for Neurosyphilis

The goal of this observational study is to identify diagnostic biomarkers for neurosyphilis in patients with the condition. The main questions it aims to answer are: What plasma biomarkers are associated with neurosyphilis? What electrophysiological characteristics (EEG and eye movement) are linked to neurosyphilis? Researchers will compare biomarker data from plasma and gut microbiome analyses with electrophysiological findings to see if these factors can help diagnose neurosyphilis. Participants will: Provide clinical information such as age, gender, symptoms, and disease course Submit blood and urine samples for proteomics and metagenomic sequencing Undergo EEG and eye movement evaluations for electrophysiological analysis

Dynamic Proteomics and Integrated Rates of Muscle Protein Synthesis During an Acute Period of Loading and Unloading

Skeletal muscle plays several different roles in the promotion and maintenance of health and well-being. The loss of muscle mass that occurs with aging, chronic muscle wasting diseases, and physical inactivity puts people at an increased risk of frailty and becoming insulin resistant, and therefore imposes a significant burden on health care spending. Resistance exercise participation has proven particularly effective for increasing muscle mass and strength. This effectiveness can be used by health care practitioners in a rehabilitation setting to promote the recovery of individuals who have undergone involuntary periods of muscular unloading (i.e. limb immobilization caused by a sports injury or reconstructive surgery). However, there is large variability in the amount of muscle mass and strength that people gain following participation in resistance exercise. Some individuals fail to increase the size of their muscle (low responders) whereas others show vary large increases in muscle size (high responders) in response to the same resistance training program. People also show differences in the amount of muscle tissue they lose when they have a limb immobilized. To circumvent variability across individuals, the investigators utilized a within-person paired Hypertrophy and Atrophy ('HYPAT') strategy that reduced response heterogeneity by \~40% (Available at: https://ssrn.com/abstract=3445673). Specifically, one leg performed resistance training for 10 weeks to induce hypertrophy, whereas the other leg underwent single-leg immobilization for 2 weeks to induce atrophy. The primary goal of the study will be to gain insight into the molecular responses to an acute period of single-leg immobilization and resistance exercise (8 days). The investigators will use an integrated systems biology approach to monitor the individual rates of over one hundred different muscle proteins.

Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)

The aim of the present study is to investigate a targeted proteomic analysis in plasma of children - of Greek origin- with type 1 diabetes (DT1) and its correlation with the electrophysiological findings that accompany diabetic peripheral neuropathy. Diabetic neuropathy is the most frequent chronic complication in adults with DT1 and rarely appears in childhood. Nevertheless, cases of acute mononeuritis have been described at the time of diagnosis of DT1. According to recent reports several biomarkers, including proteomic analysis, have been proposed for the early detection of peripheral neuropathy in children and young adults with T1DM. In the present study the researchers will attempt to investigate the role of biomarkers with targeted proteomic analysis in the plasma of children with DT1 in combination with an electrophysiological study, which includes a nerve conduction study, to detect early diabetic peripheral neuropathy, before the appearance of clinical manifestations.

Research on Potential Biomarkers of Prediabetes and Diabetes Based on MALDI-TOF MS Platform.

Through the MALDI-TOF MS platform, explore the proteomics and peptidomics differences of fasting serum/plasma and urine between non pregnant people with normal glucose tolerance test and prediabetes /diabetes patients, pregnant people with normal glucose tolerance test and pregnant diabetes patients respectively; To explore the role of its proteomics and peptidomics differences in the diagnosis of prediabetes and diabetes, and to establish a new method of differential diagnosis by using the omics data and key characteristic peaks to find potential new diagnostic markers.

Cancer-associated Muscle Mass - Molecular Factors and Exercise Mechanisms

Muscle mass loss is a common adverse effect of cancer. Muscle mass loss occurs with or without reduction in body weight. Cancer cachexia (CC) is the involuntary loss of body weight of \>5% within 6 months and it occurs in 50-80% of patients with metastatic cancer. It is estimated that CC is a direct cause of up to 30% of all cancer-related deaths. No treatment currently is available to prevent CC, likely because the chemical reactions that causes of this devastating phenomenon in unknown. No treatment currently is available to prevent muscle mass loss in patients with cancer but is urgently needed as the reduced muscle mass and function is associated with impaired physical function, reduced tolerance to anticancer therapy, poor quality of life (QoL), and reduced survival. There is evidence of an interdependence between informal caregiver (e.g. spouse) and patient QoL. Thus, identifying caregiver distress and needs can potentially benefit QoL for patients with cancer cachexia. Despite the enormous impact on disease outcomes, it is not known why the loss of muscle mass and function occurs and very few studies have investigated the underlying molecular causes in humans. In particular, there is a severe lack of studies that have obtained human skeletal muscle and adipose tissue sample material. Such reference sample materials will be invaluable to obtaining in-depth molecular information about the underlying molecular causes of the involuntary but common muscle mass and fat mass loss in cancer. At a whole body level, cancer cachexia is associated with reduced sensitivity to the hormone insulin, high levels of lipids in the blood, and inflammation. Within the skeletal muscle, the muscle mass loss is associated with elevated protein breakdown and reduced protein build-up while emerging, yet, limited data also suggest malfunction of the power plants of the cells called mitochondrions. The role of malnutrition and how it contributes to weight loss is understood only to the extent of the observed loss of appetite and the reduced food intake because of pain, nausea, candidiasis of the mouth, and breathlessness. Evidence is increasing that the environment of the intestinal system could be implicated in cancer cachexia, yet, the possible effect of cancer and the cancer treatment on the intestinal environment is not understood. Thus, large and as yet poorly understood details of this syndrome precede a later weight loss. Exercise training could help restore muscle function and how the chemical reactions works in cancer. In healthy people, and patients with diabetes, cardiovascular disease, and obesity exercise potently improves health. Exercise has been thought to slow down the unwanted effects of cancer cachexia by changing the reactions mentioned above. Thus, there is a tremendous gap in our knowledge of how and if exercise can restore the cells power plants function, muscle mass, strength, and hormone sensitivity in human cachexic skeletal muscle. Tackling that problem and examining potential mechanisms, will enable us to harness the benefits of exercise for optimizing the treatment of patients with cancer. The data will provide novel clinical knowledge on cachexia in cancer and therefore addressing a fundamental societal problem. Three specific aims will be addressed in corresponding work packages (WPs): * investigate the involvement of hormone sensitivity of insulin and measure the chemical reactions between the cells in patients with lung cancer (NSCLC) and describe the physical performance and measure amount of e.g. muscles and adipose tissue across the 1st type of cancer treatment and understand how that is related to the disease and how patients and informal caregiver feel (WP1). * find changes in the chemical reactions in skeletal muscle, adipose tissue (AT), and blood samples in these patients, to understand how to predict how the disease will develop (WP2). * measure changes of skeletal muscle tissue in response to exercise and see if it might reverse the hormone insensitivity and improve muscle signaling and function (WP3). The investigators believe that: * the majority of patients with advanced lung cancer, at the time of diagnosis already are in a cachectic state, where they lose appetite, and have hormonal changes, and an overall altered chemical actions between the cells affecting both muscle mass and AT. The investigators propose that all this can predict how the disease will progress, and how patient- and informal caregiver fell and how they rate their quality of life. * lung cancer and the treatment thereof is linked with changes in the blood, the muscle tissues, and the adipose tissues, especially in patients experiencing cachexia, that could be targeted to develop new treatment. * exercise can restore the muscles and improve insulin sensitivity and improve the function of the cells power plants in patients with lung cancer-associated muscle problems.