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NCT ID: NCT05984277 Recruiting - Clinical trials for Metastatic Non-small Cell Lung Cancer

A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.

eVOLVE-Lung02
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%.

NCT ID: NCT05983978 Recruiting - Celiac Disease Clinical Trials

No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays

Start date: January 2, 2023
Phase:
Study type: Observational [Patient Registry]

The main objective of this multicenter and observational study is to define the optimal threshold of different commercially available IgA anti-transglutaminase (tTG-IgA) antibody assays for celiac disease diagnosis (CD) avoiding the need for an intestinal biopsy. The main questions to be answered are: - Is the anti-tTG-IgA titer cut-off above 10 times the upper limit of normal (ULN) useful in all anti-tTG IgA assays? - Is the diagnostic performance of the newly defined cut-offs of anti-tTG-IgA the same in all the evaluated assays? - Is the dynamic of the anti-tTG-IgA levels after the introduction of the gluten-free diet (GFD) similar across the different assays included in the study? This is a prospective multicenter study that will enroll pediatric and adult patients with new-onset CD during the years 2023 and 2024. Serum from these patients will be collected for the determination of anti-tTG-IgA according to the local methodology (participating hospital) and by the anti-tTG IgA assays most commonly used in our country, which will be centralized in the same reference center (Hospital Universitario La Paz).

NCT ID: NCT05983770 Recruiting - Clinical trials for Kidney Transplant Rejection

Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

Start date: August 30, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.

NCT ID: NCT05983666 Recruiting - Clinical trials for Intubation Complication

POCUS ASSESSMENT FOR TRACHEAL VS OESOPHAGEAL INTUBATION

PATO
Start date: July 1, 2023
Phase:
Study type: Observational

The clinical importance of airway management has gained prominence in the last decade in most scientific societies with the aim of improving the standard of care. The WHO has focused guidelines for "Safety in Surgery", which attempt to encompass all methods that predict and recognise airway management risk and should be applied by the surgical team, and has therefore created and implemented a surgical checklist that can be useful in reducing the risk of unidentified difficulties. The same suggestion has been included in the Helsinki Declaration on Patient Safety in Anaesthesiology, signed by most European entities in cooperation with the European Society of Anaesthesiology (ESA), the European Board of Anaesthesiology (EBA-UEMS), and the World Federation of Societies of Anaesthesiology (WFA). Confirmation of correct endotracheal tube (ET) placement is a crucial step in airway management, as unrecognised oesophageal intubation can have catastrophic consequences. Numerous methods are used to verify correct ET placement, including visual confirmation of tube passage through the vocal cords during laryngoscopy, chest wall expansion during ventilation, visualisation of the tracheal rings and carina using a flexible bronchoscope, auscultation, capnometry, capnography and chest radiography. These techniques vary in their degree of precision. Although capnography is considered the gold standard for confirming tracheal intubation, it has some important limitations. In recent years, ultrasonography has been introduced as the fifth pillar of the physical examination of the patient: inspection, palpation, percussion, auscultation and insonation. For airway assessment and management, Point-of-Care UltraSound (PoCUS) has been incorporated into routine clinical practice, answering open diagnostic questions, aiding in differential diagnosis and guiding procedures. Thus, investigators propose a simple, quick and easy-to-learn approach for the interpretation of ultrasound imaging findings during airway management.

NCT ID: NCT05983367 Recruiting - Colorectal Cancer Clinical Trials

A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer

Start date: October 10, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to measure tumor response to treatment with ompenaclid (RGX-202) in patients with previously treated RAS mutant advanced or metastatic CRC. All patients will receive treatment with FOLFIRI and bevacizumab. In addition, patients will be randomized to receive either ompenaclid 3000 mg BID or matching placebo (herein referred to as Study Drug). Each treatment cycle is 28 days in duration.

NCT ID: NCT05982717 Recruiting - Clinical trials for Dravet Syndrome (DS)

A Study to Gather Information About Overall Occurrence and New Cases of Dravet and Lennox-Gastaut Syndromes in Children, Teenagers and Adults in Spain

DRALEGA
Start date: October 26, 2023
Phase:
Study type: Observational

The main aims of this study are to gather information about how many children, teenagers and adults in Spain have been diagnosed with Dravet syndrome and Lennox-Gastaut syndrome as well as to learn about the number of new Dravet syndrome and Lennox-Gastaut syndrome cases in persons in Spain. Participants' data will be taken from their medical records (charts), which were already collected as a part of their routine care in public hospitals in Spain between 01 January 2021 and 31 December 2022.

NCT ID: NCT05982210 Recruiting - Clinical trials for Diaphragm; Relaxation

The Influence of the Diaphragm Muscle and Pain Perception on Lower Limb Neuromuscular Control in Sports Practice.

Start date: July 15, 2023
Phase: N/A
Study type: Interventional

Core stability is maintained mainly by muscle function of abdominal and lumbar region, including the diaphragm muscle. It is known that exists a connection between trunk's muscle activity and the movement of lower limb and lower limb and low back injuries are related to core alterations. Thus, a randomized clinical trial is planned to analyze the effectiveness of an exercises and manual therapy of the diaphragm and ribs program designed, aiming to analyze the correlation between rib cage mobility and lower limb neuromuscular control in young healthy subjects.

NCT ID: NCT05982093 Recruiting - Breast Cancer Clinical Trials

Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer

SOLTI-2104
Start date: October 3, 2023
Phase: Phase 2
Study type: Interventional

PREMIERE parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study in premenopausal women with primary operable HR+/HER2-negative breast cancer with aiming at evaluating the biological effects of elacestrant with or without triptorelin.

NCT ID: NCT05981092 Recruiting - Clinical trials for Cardiomyopathy, Dilated

A Study About the Natural History in Adults With BAG3 Dilated Cardiomyopathy (a Type of Heart Disease)

BAG3 DCM
Start date: October 14, 2022
Phase:
Study type: Observational

The purpose of this study is to learn about the natural progression of DCM (dilated cardiomyopathy) caused by BAG3 gene mutations. DCM is a condition as the heart muscle is weakened and the heart becomes enlarged. This makes it hard for the heart to pump enough blood for the body. The study is seeking up to about 35 participants who have: - BAG3 mutation (change in the gene) that causes or is likely to cause dilated cardiomyopathy - NYHA (New York Heart Association) Class I-IV at screening (Stage B-D) - Left Ventricular Ejection Fraction less than or equal to 50% (meaning reduced heart function) All participants in this study will receive their usual treatment. The investigators will observe the natural progression of people who have BAG3 DCM. This will help the investigators better understand the disease and aid in future research. Participants will take part in this study for one year. During this time, participants will visit the site at least 4 times (about every 3 months). Participants will undergo study procedures and give information about their health. These procedures will include a physical exam, cardiac magnetic resonance imaging, echocardiography, ECG monitoring, activity monitoring, cardiopulmonary exercise testing, and blood tests. Participants will answer questions about health and quality of life. The study team will also call participants about 1 time over the phone.

NCT ID: NCT05980598 Recruiting - Clinical trials for Head and Neck Neoplasms

TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma

BelieveIT-201
Start date: September 29, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and pembrolizumab given prior to curative intent surgery in treatment of participants with newly diagnosed Stage III/IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). After surgery, participants will receive local standard-of-care treatment and will be followed for safety, efficacy, and survival for up to 2 years. This trial contains a safety run-in to evaluate the safety and tolerability of the two treatment arms: Arm A (TransCon TLR7/8 Agonist plus pembrolizumab) and Arm B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ). The safety run-in will be followed by the randomized Phase 2, open-label part of the trial comparing the safety, efficacy and survival of treatment Arm A or Arm B compared to treatment Arm C (pembrolizumab monotherapy).