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NCT ID: NCT06192342 Recruiting - Stroke Clinical Trials

Ventilatory Parameters in Acute Neurological Injury

Start date: May 5, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to test the association between baseline ventilatory parameters (in particular mechanical power (MP), mechanical power normalized to predicted body weight (MP/PBW) and driving pressure (DP) with the baseline neurological status (assessed through the Glasgow coma score) in adults patients under mechanical ventilation with acute neurological injury secondary to stroke, brain trauma or subarachnoid hemorrhage. The main question[s]it aims to answer are: 1. In patients with acute neurological injury under mechanical ventilation, is there a correlation between the acute neurological injury, assessed using the Glasgow scale on admission, and baseline ventilatory parameters? 2. In patients with acute neurological injury under mechanical ventilation, are the baseline ventilatory parameters altered at baseline?

NCT ID: NCT06191315 Recruiting - Asthma Clinical Trials

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Start date: January 3, 2024
Phase: Phase 3
Study type: Interventional

This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to <6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to <6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A [4-week Screening and a 52-week treatment period] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).

NCT ID: NCT06183931 Recruiting - Clinical trials for Transthyretin Amyloid Cardiomyopathy

Study of ALXN2220 Versus Placebo in Adults With ATTR-CM

DepleTTR-CM
Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of ALXN2220 in the treatment of adult participants with ATTR-CM by evaluating the difference between the ALXN2220 and placebo groups as assessed by the composite endpoint of all-cause mortality (ACM) and total cardiovascular (CV) clinical events.

NCT ID: NCT06183593 Recruiting - Clinical trials for Brain Response Evoked by Radiofrequency Stimuli in Humans

Accuracy in the Evaluation of Brain Response to Mechanical and Radiofrequency Stimuli in Humans

Start date: March 11, 2024
Phase: N/A
Study type: Interventional

Under normal conditions, pain arises as a consequence of the activation of nociceptive afferents (small fibers) by an external stimulus with sufficient intensity to potentially cause tissue damage. This peripheral activation is processed as perception of pain by the central nervous system. In order to reliably evaluate the state of the nociceptive system in both clinical and experimental settings, standardized tests are essential. Quantitative sensory testing (QST) is a set of tests used to measure the intensity of a stimulus that produces a specific sensory perception in a subject. For example, if we gradually apply pressure, the point where the sensation changes from pressure to pain is called the pressure pain threshold. This type of test can be performed with different types of stimuli, including hot and cold stimuli or mechanical stimuli. Although these tests have been shown as reliable in healthy volunteers and pain patients, they are subjective in their nature, since they are based on a conscious evaluation of tested subjects. Likewise, these measures show substantial variability due to differences in the application of the tests by individual examinators. In short, even though the method is quantitative, its methodological characteristics make it subjective and dependent on both the operator and the subject under study. Moreover, contrasting results have been recently found regarding the measurement variability when repeating the QST at intervals of days. Thus, it is essential to investigate and develop new QST alternatives to obtain objective markers that may potentially contribute to the understanding of the mechanisms behind chronic pain conditions.

NCT ID: NCT06181435 Recruiting - Dermatitis Atopic Clinical Trials

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

Start date: December 21, 2023
Phase: Phase 3
Study type: Interventional

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).

NCT ID: NCT06177860 Recruiting - Clinical trials for Myocardial Infarction

Clinical and Atherosclerotic Characteristics of Patients With ACS Associated With Cocaine Use

Start date: November 17, 2023
Phase:
Study type: Observational

Cocaine use has increased in our country in recent decades. It is associated with cardiovascular events and early atherosclerotic disease. Acute coronary syndrome (ACS) is one of its most frequent and serious manifestations. There is a lack of scientific information on ACS associated with acute and chronic cocaine use in Argentina. This study aims to describe the socioeconomic, clinical, and coronary angiographic characteristics, as well as the extent of atherosclerotic disease in patients with ACS associated with cocaine use, and to compare them with ACS not associated with cocaine use. Methods: We propose an observational, analytical, single-center, two-phase study, with a retrospective and a prospective component. Patients with a diagnosis of ACS admitted to the coronary care unit of a high-complexity public hospital will be included. Clinical, biochemical, coronary angiographic, extracoronary atherosclerotic disease extension and prognostic variables will be described. These variables will be compared between patients with cocaine-associated ACS and non-cocaine-associated ACS.

NCT ID: NCT06170788 Recruiting - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

Start date: December 15, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.

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).

NCT ID: NCT06154785 Recruiting - Colorectal Surgery Clinical Trials

Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)

CROSS
Start date: December 15, 2023
Phase:
Study type: Observational [Patient Registry]

The objective of this prospective, international cohort is to incorporate the low stable pressure (using Airseal Insufflator) approach and its associated parameters into the early rehabilitation program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.

NCT ID: NCT06152575 Recruiting - Multiple Myeloma Clinical Trials

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

Start date: February 8, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: - Are 18 years of age or older and have MM. - Have received treatments before for MM. - Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as: - a shot under the skin at the study clinic - through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.