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NCT ID: NCT05327582 Recruiting - Pancreatic Cancer Clinical Trials

An Open-label, Phase I/II Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC

Start date: April 12, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Immunotherapy of cancer based on PD-1/PD-L1 blockade has prompted a revolution in cancer clinical management, albeit as yet immunotherapy-based treatment approaches in pancreatic cancer and biliary tract cancer (BTC) remain to have proven value, highlights the urgency for designing novel therapeutic strategies to combat these deadly diseases. The immunomodulatory effect of lenvatinib (Lenvatinib is an oral multi-kinase inhibitor) on tumor microenvironments may contribute to antitumor activity of immune checkpoint blockade. This one-arm, phase I/II study is designed to assess the safety and efficacy of the combined regimen of Durvalumab (anti-PD-L1 antibody), Lenvatinib and Paclitaxel albumin (nab-paclitaxel).

NCT ID: NCT05334797 Recruiting - Pain, Shoulder Clinical Trials

The Effect of Hot Application on Post Laparoscopic Shoulder Pain and Analgesic Use

Start date: April 12, 2022
Phase: N/A
Study type: Interventional

The aim of this study; To evaluate the effect of hot application on postlaparoscopic shoulder pain and analgesic use in patients undergoing upper laparoscopic surgery in general surgery.

NCT ID: NCT05351775 Recruiting - Clinical trials for Cardiovascular Diseases

Low Workload Concept for the Detection of Silent Atrial Fibrillation (AF) and Atrial Fibrillation Burden in Patients at High Risk of AF and Stroke

CARE-DETECT
Start date: April 12, 2022
Phase: N/A
Study type: Interventional

Patient-centered novel e-health technology and services will lay the foundation for future healthcare systems and services to support health and welfare promotion. Yet, there is a lack of ways to incorporate novel technological innovations into easy-to-use, cost-effective and low workload treatment. The detection of atrial fibrillation (AF) paroxysms and its permanent form as well as the prevention of AF-related strokes are major challenges in cardiology today. AF is often silent or asymptomatic, but the risk of ischemic stroke seems to be similar regardless of the presence or absence of symptoms. CARE-DETECT algorithm development part I will investigate following topics: 1. The usefulness and validity of bed sensor and mobile phone application in rhythm disorder capture compared to gold standard ECG-holter monitoring (Faros ECG) 2. Accuracy of AF detection from PDL data 3. Technical development of algorithms to detect arrhythmia from data collected with these novel devices 4. Development of a pre-processing tool that will evaluate the collected data and generate a preliminary filtered report of the raw data to ease clinician's workload in data handling and rhythm evaluation. CARE-DETECT clinical trial (part II) proposal provides a new concept for low workload for healthcare personnel, high diagnostic yield in silent AF detection and AF burden evaluation. CARE-DETECT protocol proposal seeks to address following issues: 1. Can a combination of actively used smartphone application and passive monitoring with bed sensor (with upstream ECG) - compared to routine care - enhance the detection of AF in patients who are at increased risk of stroke and have undergone a cardiac procedure? 2. What is the actual AF burden in paroxysmal AF patients after the detection of new-onset AF? 3. Can a direct-to-consumer telehealth with integrated cloud-based telecardiology service for medical professionals improve the efficacy of silent AF detection and what is the AF burden in patients suffering of (asymptomatic) paroxysmal AF and secondarily what is the cost-effectiveness of these new screening methods? 4. Additionally, during the hospitalization phase of the study part II PDL data will be collected in the intervention group. PDL data will be analyzed offline with the purpose to develop new methods and will not be used to monitor treatment or for diagnosis.

NCT ID: NCT05352347 Recruiting - COVID-19 Pneumonia Clinical Trials

Phase 2b/3 Trial of NuSepin® in COVID-19 Pneumonia Patients

Start date: April 12, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

A Randomized, Double-blinded, Placebo-controlled, Parallel-treatment Group, Adaptive Design, Multi-center, Phase 2b/3 Trial to Evaluate Efficacy and Safety of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients

NCT ID: NCT05361694 Recruiting - Multiple Myeloma Clinical Trials

Two Biologically and Clinically Distinct Entities: Progressive Versus Stable Multiple Myeloma (MM) Precursor Conditions

TRANSFORMM
Start date: April 12, 2022
Phase:
Study type: Observational

The key aim of the study is to define the two biologically and clinically distinct entities: progressive versus stable myeloma precursor conditions.

NCT ID: NCT05406167 Recruiting - Cancer Clinical Trials

Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System

PREMIER
Start date: April 12, 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of this prospective cohort study is to assess clinical and quality of life measures as well as to define the severity of adverse effects for the use of the RefleXion system to deliver intensity-modulated radiotherapy (IMRT), stereotactic body radiotherapy (SBRT), in standard of care (SOC) use in the treatment of local,loco-regionally advanced, and oligometastatic malignancies. In addition, patient costs and charges will be analyzed to quantify the health economic impact of this modality. Workflow and quality of radiotherapy planning including a collection of dosimetric data will also be analyzed.

NCT ID: NCT05435560 Recruiting - Healthy Clinical Trials

Neurochemical Mechanisms of the Awake vs. Anesthetized Brain

Start date: April 12, 2022
Phase: Early Phase 1
Study type: Interventional

The investigators will be studying the sedative drug dexmedetomidine using hybrid PET/fMRI/EEG imaging to better understand the neuropharmacology of anesthesia/artificially induced sleep.

NCT ID: NCT05447650 Recruiting - Clinical trials for Age-Related Macular Degeneration

Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)

i-SIGHT
Start date: April 12, 2022
Phase: N/A
Study type: Interventional

Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).

NCT ID: NCT05843539 Recruiting - Quality of Life Clinical Trials

Adverse Childhood Experiences, Adaptation and Breast Cancer

CAPONE
Start date: April 12, 2022
Phase:
Study type: Observational

Adverse Childhood Experiences (ACEs) have long been linked to mental health problems in adulthood. In the case of cancer, no study has considered that such an anteriority could make patients more vulnerable emotionally, even though the presence of reactionary disorders such as stress, anxiety or depression are characteristic of such a pathology. Activated during periods of stress and therefore during the illness, even the attachment system is mobilized and must be considered to allow more understanding of the illness experience. The attachment style can be seen here as an individual dimension that plays a role in the emotional regulation and resilience of patients. It is also particularly solicited during the remission phase, a complex and singular period of cancer disease that confronts patients with an ambivalence of hope and fear. The fear of recurrence is a concern that the cancer may return or progress in the same organ or in another part of the body. This is a determining factor in the occurrence of anxiety-depressive disorders. Finally, several studies have shown a strong association between depression/anxiety and Cancer-Related Fatigue (CRF) after treatment, especially during the remission phase. ACEs leave physiological and epigenetic impact that can nowadays be easily evaluated, thus providing additional evidence between adversity, physiological and epigenetic vulnerability and the ability to adapt to life's challenges such as cancer. Life history changes are mediated by changes in cellular mechanisms affecting genome expression. It is currently widely demonstrated that ACEs increases epigenetic modifications. The interest of this project is therefore to highlight the psychological consequences related to the occurrence of cancer in the developmental history (in terms of adversities) of patients who have completed adjuvant chemotherapy for breast cancer, taking into account the patients' previous attachments, resilience, fear of recurrence and perceived fatigue in order to consider their interactions and their effects on their psychological health and ultimately on their quality of life.

NCT ID: NCT05940311 Recruiting - Melanoma (Skin) Clinical Trials

Versatile Ampification Single-Molecule Detection in Liquid Biopsy

VerSiLiB
Start date: April 12, 2022
Phase:
Study type: Observational [Patient Registry]

Robust detection of single molecules in complex biological fluids is the ultimate goal in the field of disease biomarker analysis. Conventionally, to enable the quantitative analysis of individual molecules in macroscopic volumes, analyte pre-concentration and sample partitioning into fL-nL compartments has been combined with the amplification of the specific recognition events. In these setups, the positive or negative detection of fluorescence signal is triggered by enzymatic reactions occurring in each compartment. Binary readout based on Poisson statistics quantifies ultra-low concentrations of analyte molecules. This approach has been adopted for nucleic acids analysis in current digital PCR, and is also available for proteins in a technique coined as digital ELISA. The objective of VerSiLiB is to develop an enzyme-free amplification strategy for the analysis of both protein and nucleic acid analytes with the single digital platform that offers means to access additional information on target analytes not achievable with current technologies. Method is based on novel affinity-mediated-transport amplification, where affinity interaction of target analyte with a specific ligand attached to a magnetic nanoparticle transporter is accompanied with rapid shuttling of fluorescent tracers that serve as reporters. By applying external magnetic field, tracers are transported from the tracer storage side (where they are dark) to tracer active side (where they become bright) only if target analyte is present in the small reaction compartment. Tailored plasmonic nanostructures will be prepared at the storage and active sides of the compartment to render the tracer either dark or bright. The aim is to perform technology validation for the novel VerSiLiB proteogenomics amplification platform in cancer management using biobanked liquid biopsy samples.