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Намерени 4,436 изпитвания Стр. 60 от 222

Набира участници Фаза 1

Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors

HER2-Expressing Solid Tumors

This clinical trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-304 in adults with advanced HER2-expressing solid tumors. The main questions it aims to answer are: * What is the safety profile of MT-304 when administered alone or with nivolumab? * What is the recommended Phase 2 dose (RP2D) of MT-304? Participants will: * Receive MT-304 alone (every 14 days) or with nivolumab (every 28 days). * Attend regular clinic visits for assessments and monitoring. * Continue treatment until disease progression, unacceptable toxicity, or study discontinuation.

Начало: 25.11.2025 Край: 30.03.2028 Възраст: от 18 г. Лечение

Australia Myeloid Therapeutics NCT07334119

Набира участници Фаза 4

Jack Jumper Ant Venom Immunotherapy Long-term Effectiveness Investigation

Allergy Immunotherapy Venom Allergy

Jack Jumper ant (JJA) venom allergy is a uniquely Australian medical condition. It is the leading cause of venom allergy and affects up to three per cent of the population. 70 percent of people with JJA allergy will have another reaction on a repeat sting and this sensitivity appears to persist for many years. Venom immunotherapy (VIT) has been shown to be a safe and effective treatment in the prevention of severe systemic allergic reactions (anaphylaxis) to future stings. It is currently offered to patients as standard care in Tasmania, South Australia and Victoria. However, whilst JJA VIT has been used for many years, there is a lack of evidence on the long-term benefit of the treatment and how it impacts patient quality of life. This trial will offer patients who have completed a JJA VIT program (between 3 and \< 6-years duration) and have been off-treatment for at least 18-months and \< 5 years, to have a supervised JJA sting challenge and blood test to assess their JJA venom tolerance level. It will also ask them to complete a set of questionnaires at different timepoints to obtain a history of their exposure and reactions to JJA stings outside of the hospital setting (field stings), and to measure the impact of the completed VIT and knowledge of their sting challenge outcome on their quality of life and their behaviours around auto-injectors. These measures will be used to explore the long-term effectiveness of JJA VIT and the impact of a sting challenge post VIT on a patient's quality of life.

Начало: 25.11.2025 Край: 01.10.2029 Възраст: от 18 г. Лечение

Australia Murdoch Childrens Research Institute NCT06935890

Набира участници Фаза 2

A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis

This phase 2b study is designed to evaluate the safety and efficacy of KT-621 in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD), a common form of eczema. The main goals of this study are to learn how effective KT-621 is at reducing the severity and extent of AD, the safety and tolerability of KT-621, how KT-621 behaves in the body, and how the body responds to KT-621. This is a 16-week double-blind, placebo-controlled study with a 52-week open-label period.

Начало: 24.11.2025 Край: 01.06.2028 Възраст: 12–75 г. Лечение

Australia, Canada, Czechia +5 Kymera Therapeutics, Inc. NCT07217015

Набира участници Фаза 2

A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Bipolar Disorder

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.

Начало: 24.11.2025 Край: 01.11.2027 Възраст: 18–75 г.

Argentina, Brazil, China +5 Eli Lilly and Company NCT07286175

Набира участници Фаза 4

A Study of Tirzepatide (LY3298176) Compared With Standard of Care in Adult Participants With Obesity and Without Diabetes (SURMOUNT-REAL UK)

Obesity

The purpose of this study is to evaluate tirzepatide within a real-world setting to assess body weight loss and incidence of type 2 diabetes in adults without diabetes who have obesity and at least one weight-related comorbid condition. Participation in the study will last about 260 weeks.

Начало: 24.11.2025 Край: 01.07.2032 Възраст: от 18 г.

United Kingdom Eli Lilly and Company NCT07247084

Набира участници Фаза 1

Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors

Pancreatic Ductal Adenocarcinoma Non-Small Cell Lung Cancer HR+/HER2- Ductal and Lobular Breast Cancer Triple Negative Breast Cancer +2

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-DFC413 and safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with solid tumors

Начало: 24.11.2025 Край: 09.05.2029 Възраст: 18–100 г.

Canada, Denmark, France +2 Novartis Pharmaceuticals NCT07261631

Набира участници Фаза 3

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Parkinson's Disease

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.

Начало: 24.11.2025 Край: 30.06.2031 Възраст: 50–85 г. Лечение

Australia, Brazil, Canada +10 Hoffmann-La Roche NCT07174310

Набира участници

Comparison of the Efficacy and Safety of Ciprofol Versus Propofol for Sedation in ICU Patients Undergoing Non-Invasive Ventilation

Respiratory Failure Critical Illness

Sedation is frequently required in critically ill patients admitted to the intensive care unit (ICU), including those receiving non-invasive respiratory support such as high-flow nasal cannula (HFNC), non-invasive ventilation (NIV), or conventional oxygen therapy. Anxiety, agitation, dyspnea, and poor tolerance of respiratory support may compromise treatment adherence and increase the risk of respiratory deterioration and endotracheal intubation. Appropriate sedation may improve patient comfort, facilitate respiratory support, and reduce complications. However, sedation in non-mechanically ventilated ICU patients remains challenging because excessive sedation may lead to respiratory depression or hemodynamic instability. Propofol is commonly used for ICU sedation because of its rapid onset and controllable depth of sedation. Nevertheless, propofol is associated with several adverse effects, including respiratory depression, hypotension, and injection pain, which may limit its use in patients without invasive mechanical ventilation. Ciprofol is a novel short-acting intravenous sedative that acts as a gamma-aminobutyric acid type A (GABA-A) receptor agonist and is structurally related to propofol. Previous studies have demonstrated that ciprofol has rapid onset, predictable sedation, less injection pain, and a potentially lower incidence of respiratory depression and hemodynamic instability compared with propofol. Clinical studies have shown favorable safety and efficacy profiles of ciprofol in procedural sedation, anesthesia induction, and sedation in mechanically ventilated ICU patients. However, evidence regarding its use in ICU patients receiving non-mechanical ventilation is still limited. This study aims to compare the effectiveness and safety of ciprofol versus propofol for sedation in adult ICU patients who are not receiving invasive mechanical ventilation. The study will be conducted as a multicenter retrospective cohort study involving approximately 30 tertiary hospitals in China. Adult ICU patients treated between January 1, 2022 and July 30, 2024 who received intravenous sedation with either ciprofol or propofol while receiving non-invasive respiratory support (including NIV, HFNC, or conventional oxygen therapy) will be included. The primary outcomes are sedation success rate and the incidence of respiratory depression. Sedation success is defined as maintaining the Richmond Agitation-Sedation Scale (RASS) within the target range of -2 to +1 for at least two consecutive hours without discontinuation of the sedation regimen or switching to another sedative. Respiratory depression will be defined based on predefined criteria including severe hypoxemia, markedly reduced respiratory rate, abnormal end-tidal carbon dioxide levels, or apnea. Secondary outcomes include endotracheal intubation rate during the sedation period, ICU length of stay, ICU mortality, and the requirement for vasoactive agents. Propensity score matching and multivariable statistical models will be used to adjust for baseline differences and potential confounders between treatment groups. This real-world study aims to provide evidence regarding the clinical effectiveness and respiratory safety of ciprofol compared with propofol for sedation in ICU patients without invasive mechanical ventilation. The findings may help optimize sedation strategies in critically ill patients receiving non-invasive respiratory support and provide evidence to support future prospective clinical trials.

Начало: 24.11.2025 Край: 30.06.2026 Възраст: от 18 г.

China Nanfang Hospital, Southern Medical University NCT07536750

Набира участници

Positioning of Children With Acute Respiratory Insufficiency

Acute Respiratory Disease

Acute respiratory insufficiency is one of the most common causes of hospitalization and death among young children. It often affects small children who, due to infections with RSV (respiratory syncytial virus), other cold viruses, or bacteria, experience difficulty breathing, rapid breathing, increased heart rate, low oxygen levels in the blood, and reduced appetite. If left untreated, a child can become exhausted, lose consciousness, and ultimately die from the condition. Children with severe acute respiratory insufficiency occupy most of the acute care beds in the pediatric wards of hospitals during the winter months. Some children are treated simply with saline inhalations, nasal saline drops, and suctioning of the nose, but many require respiratory support in the form of Continuous Positive Airway Pressure (CPAP) or high-flow oxygen therapy. In adults, it has been observed that prone positioning can improve blood oxygenation compared to supine positioning in cases of acute respiratory insufficiency. The purpose of this study is to investigate whether there are benefits or drawbacks to positioning small children admitted for difficulty breathing due to respiratory infections in a prone position instead of a supine position. The study will include a total of 40 children with acute airway disease who have been prescribed respiratory support in the form of CPAP or high-flow oxygen. The study will last a total of 2 hours and will not involve any uncomfortable procedures or pose any risks to the child. The Study Itself: Once the child has CPAP or high-flow oxygen administered via the nose, the child will be positioned for 1 hour in the prone position and 1 hour in the supine position. The order will be random and determined by lottery. A nurse will record the child's breathing in both the prone and supine positions. After the two hours, the child will be placed in the supine position, which is standard practice in the department. The child will have a pulse oximeter on both during the study and afterwards.

Начало: 24.11.2025 Край: 01.04.2028 Възраст: до 12 г.

Denmark Odense University Hospital NCT07170085

Набира участници Фаза 3

REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants

Symptomatic Venous Thromboembolism (VTE)

This study is researching an experimental drug called REGN7508 versus Acetylsalicylic Acid (ASA) (each called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery compared to acetylsalicylic acid. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Начало: 24.11.2025 Край: 16.07.2027 Възраст: от 18 г.

United States Regeneron Pharmaceuticals NCT07213778

Набира участници

Closed-Loop Neurofeedback Targeting the Left Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety

Coronary Heart Disease (CHD) Anxiety Disorders

The goal of this clinical trial is to test whether closed-loop fNIRS-BCI neurofeedback(NF) targeting the left dorsolateral prefrontal cortex(DLPFC) can reduce cardiac autonomic arousal, indexed by baseline-corrected heart rate(HR) under cold-induced pain stress, in adults with stable coronary heart disease(CHD) and comorbid anxiety. The main questions it aims to answer are: Does real left DLPFC neurofeedback, compared with sham neurofeedback, lead to a greater reduction in baseline-corrected HR during the cold-induced pain stimulation window? Does real neurofeedback produce stronger volitional upregulation of left DLPFC activation and higher inter-hemispheric synchronisation between left and right DLPFC than sham neurofeedback? Are changes in baseline-corrected HR statistically associated with, and partly mediated by, changes in left DLPFC activation or DLPFC inter-hemispheric synchronisation? What adverse events(AEs) occur during adaptive training and the formal experimental session, and do AE rates differ between the two groups? Researchers will compare a real neurofeedback group with a sham neurofeedback group to determine whether targeting the left DLPFC via closed-loop fNIRS-BCI yields superior modulation of cardiac autonomic responses and prefrontal activation patterns in CHD patients with anxiety. Participants will: undergo cardiac and psychiatric screening to confirm stable CHD, DSM-5 anxiety disorder, and other eligibility criteria; attend three adaptive training sessions(days 1-3) with fNIRS-BCI neurofeedback targeting the left DLPFC, combined with slow-wave auditory stimulation and mild cold-water exposure, while ECG is recorded; on day 4, complete one formal experimental session consisting of 15 blocks of cold-induced pain stimulation and slow-wave auditory stimulation, with simultaneous fNIRS and ECG recording, receiving either real or sham left DLPFC neurofeedback according to randomisation, and continuous monitoring for adverse events.

Начало: 23.11.2025 Край: 30.05.2026 Възраст: от 18 г.

China Shenyang Medical College NCT07244484

Набира участници Фаза 2

Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)

Fragile X Syndrome

This study is a multicenter, double-blind, randomized, placebo-controlled study to assess the safety and tolerability of 3 doses of MRM-3379 in male participants with Fragile X Syndrome ages 16 to 45 (inclusive). In addition, a parallel cohort of participants ages 13 to \

Начало: 22.11.2025 Край: 01.10.2027 Възраст: 13–45 г.

United States Mirum Pharmaceuticals, Inc. NCT07209462

Набира участници Фаза 3

Evaluation of Efficacy and Safety of Suzetrigine (SUZ) for Pain Associated With Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathic Pain

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine in participants with pain associated with diabetic peripheral neuropathy (DPN).

Начало: 21.11.2025 Край: 06.04.2027 Възраст: 18–80 г.

United States Vertex Pharmaceuticals Incorporated NCT07231419

Набира участници Фаза 4

Phase 4 Study: Long-term Safety and Efficacy of NT-501 in MacTel Type 2, Including Sham Procedure Participants

Macular Telangiectasia Type 2 (MacTel)

The purpose of this global, multicenter, open-label, Phase 4 clinical extension study is to evaluate the long-term safety and efficacy of revakinagene taroretcel-lwey (Encelto™; hereinafter referred to as NT-501), in participants with macular telangiectasia type 2 (MacTel) who previously received the intraocular implant in a Phase 1, Phase 2, or Phase 3 clinical study. In addition, this study will evaluate the safety and efficacy of NT501 in participants who previously underwent the sham procedure in a Phase 3 MacTel clinical study and elect to have NT-501 implanted intraocularly in this Phase 4 study.

Начало: 21.11.2025 Край: 15.01.2032 Възраст: от 18 г. Лечение

Australia, France, Germany +2 Neurotech Pharmaceuticals NCT06971939

Набира участници

An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic Kidney Disease and Type 2 Diabetes in a Routine Medical Care Setting in South Korea

Chronic Kidney Disease Type 2 Diabetes Mellitus

This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone are collected and studied. Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and extra water from the blood. Type 2 diabetes occurs when the body does not produce enough insulin or does not use it effectively, leading to high blood sugar levels that can harm the kidneys. As a result, CKD can develop as a complication of T2D. The study drug, finerenone, is already approved for doctors to prescribe to patients with CKD and T2D. Finerenone is a medication that works by blocking certain proteins known as mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. The main purpose of this study is to learn more about characteristics and treatment patterns of people with CKD and T2D who have recently started or will start finerenone treatment as prescribed by their doctor as part of their routine medical care in South Korea. The FINE-REAL Korea study is designed to collect additional data on people with CKD and T2D who are treated with finerenone according to the approved product information, and it will work alongside the original FINE-REAL study (NCT05348733) to gather enough information for safety assessments in Korean population. To achieve this, researchers will collect data on: * Clinical characteristics of participants, including their medical history related to CKD and T2D, blood pressure, and heart health. * Reasons for starting finerenone. * Reasons for stopping finerenone early. * The planned and actual duration of finerenone treatment. * The dosing of finerenone. * Other medications taken alongside finerenone. The study will also monitor any medical problems (known as adverse events) that participants may experience during the study. All adverse events will be recorded, regardless of whether they are related to the treatment. One specific concern is hyperkalemia, which refers to high potassium levels in the blood. This condition can occur when finerenone is used with certain blood pressure medications. Researchers want to understand how often hyperkalemia happens and whether it leads to: * Early discontinuation of finerenone treatment. * The need for dialysis, a procedure that filters waste from the blood. * Hospitalization for care. Data for this study will be collected from medical records and through interviews conducted by study doctors during routine medical visits. Participants will be involved in the study for up to 12 months, although this duration may be shorter if their finerenone treatment is stopped early.

Начало: 20.11.2025 Край: 28.01.2028 Възраст: от 18 г.

South Korea Bayer NCT07232537

Набира участници

Trauma-Informed Care for Smoking Cessation for Pregnancy

Smoking Cessation Tobacco Smoking Tobacco Use Cessation Smoking Reduction +3

Trauma-informed approaches have been shown to support recovery from other substance use disorders and involve four key elements: (1) Realizing the prevalence of trauma and pathways to recovery, (2) Recognizing symptoms of trauma, (3) Responding by embedding knowledge of trauma into practices and policies and (4) Resisting re-traumatization (the 4Rs). In close partnership with Breathe California and a public safety-net clinic in San Francisco that serves primarily racial and ethnic minoritized (REM) pregnant women, the 4Rs along with the Ask, Advise, Assess, Assist and Arrange (the 5As) evidence-based intervention for tobacco cessation that is delivered by health care professionals and is a US Public Health Services clinical practice guideline for treating tobacco will be used to create and implement a smoking cessation intervention for pregnant women with experiences of trauma.

Начало: 19.11.2025 Край: 31.07.2026 Възраст: от 18 г.

United States University of California, San Francisco NCT07129590

Набира участници Фаза 3

Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp

Actinic Keratosis

This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study evaluates the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for field-directed treatment of actinic keratosis (AK) on the face or bald scalp. Approximately 160 adult patients with 4-8 mild to moderate AK lesions will be randomized into four treatment arms based on two variables: type of treatment (active drug or vehicle) and incubation time. During the study, up to 2 PDT sessions may be administered depending on the clearance of lesions. The primary endpoint is complete clearance rate (CCR) at Week 12. Secondary endpoints include AK clearance rate (AKCR), partial clearance, change in total lesion count and area, recurrence rate, cosmetic response, and patient satisfaction. Safety assessments include adverse events, local skin reactions, vital signs, and lab tests.

Начало: 19.11.2025 Край: 01.04.2027 Възраст: 18–85 г.

United States Sun Pharmaceutical Industries, Inc. NCT07144345

Набира участници

Closed-Loop Neurofeedback Targeting the Right Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety

Coronary Heart Disease (CHD) Anxiety Disorders

The goal of this clinical trial is to test whether real-time fNIRS-BCI neurofeedback targeting the right dorsolateral prefrontal cortex (right DLPFC), using active volitional control during a slow-wave auditory acoustic paradigm, can suppress cardiac sympathetic activity and improve autonomic regulation in right-handed patients with stable coronary heart disease (CHD) and comorbid DSM-5 anxiety. The main questions it aims to answer are: Does real neurofeedback, compared with sham, reduce baseline-corrected heart rate during the auditory stimulation window? Does real neurofeedback, compared with sham, increase HRV spectral power around 0.0167 Hz (1/60 Hz) and produce stronger suppression of right DLPFC activation? Does suppression of right DLPFC activation mediate the effect of group assignment on heart rate? If there is a comparison group: Researchers will compare the real neurofeedback group with the sham (non-contingent) feedback group, which uses identical audio and interface, to determine whether coupling feedback to right DLPFC activity yields autonomic benefits. Participants will: Complete eligibility screening in cardiology and psychiatry and provide informed consent; baseline demographics, medical history, vital signs, and medications are recorded (HAMA/HAMD used for eligibility only). Undergo a 3-day adaptation phase to practice active volitional self-regulation while viewing a real-time energy bar mapped to right DLPFC statistics; adaptation data are not analyzed for outcomes. Attend two formal sessions (Days 4-5), each with 15 blocks of 60 s (20 s rest + 40 s stimulus). The auditory stimulus is a 1 Hz amplitude-modulated pure tone at approximately 60 dB; 10-second white-noise bursts are randomly embedded within the 40-second window. During the stimulation period, participants receive real or sham feedback on right DLPFC activation and act to push the energy bar below an unlabeled threshold line using active volitional strategies. Undergo synchronous fNIRS (HbO) and 3-lead ECG (1,000 Hz) recording throughout; online processing and rendering performance metrics are logged; adverse events are monitored and managed per protocol.

Начало: 19.11.2025 Край: 21.08.2026 Възраст: от 18 г.

China Shenyang Medical College NCT07238920

Набира участници

Effect of Using a Reminder to Encourage Patients to be Active During Their Hospital Stay.

Inpatients Frail

Around 30% of patients aged 65 and over experience functional decline due to hospitalization. Physical inactivity, often without medical justification, is common during hospital stays.This immobility leads to loss of autonomy, muscle strength, and increases post-discharge risks. Slow walking for 25-40 minutes daily significantly improves functional capacity. However, it could be difficult to reach this time of walking due to a lack of physiotherapist in hospital. A vibrating watch may encourage patients to walk or perform strengthening exercises. This simple intervention aims to improve function without requiring additional staff or resources

Начало: 19.11.2025 Край: 01.01.2029 Възраст: от 50 г.

Belgium, France Groupe Hospitalier du Havre NCT07492745

Набира участници Фаза 1

Study to Assess Safety, Tolerability, PK, and PD of Multiple Doses of ZE63-0302 Administrated Orally in T2DM Patients.

Type 2 Diabetes

A Phase 1b study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of ZE63-0302 administrated orally in T2DM patients.

Начало: 19.11.2025 Край: 01.11.2026 Възраст: 18–65 г. Лечение

Australia, Uzbekistan Eilean Therapeutics NCT07234864

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