Search trials – HealthDB

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Намерени 4,436 изпитвания Стр. 134 от 222

Recruiting

BE WELL With Migraine: Brain Education and WELLness With Migraine

Migraine

The goal of this randomized clinical trial is to evaluate two different non-drug, virtual treatment options designed to improve the lives of patients with migraine. Both interventions involve 8 weekly sessions and an online platform with additional content and learning. Participants can stay on all their medications during this study. Information from this study may help determine how to better treat migraine.

Начало: 31.07.2024 Край: 31.12.2027 Възраст: от 18 г.

United States Wake Forest University Health Sciences NCT05987592

Recruiting

Effects of PBMT-sMF in Mechanically Ventilated Patients

Respiratory Failure

The goal of this clinical trial is to evaluate the effectiveness of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) in adult patients who require mechanical ventilation. The main questions it aims to answer are: (i) Does PBMT-sMF lower the length of stay in the intensive care unit (ICU) for mechanically ventilated patients? (ii) Does PBMT-sMF increase the diaphragm thickness in mechanically ventilated patients in the ICU? Researches will compare active PBMT-sMF plus standard of care to a placebo PBMT-sMF plus standard of care to see if active PBMT-sMF works to prevent or retard disuse atrophy of the diaphragm during mechanical ventilation.

Начало: 31.07.2024 Край: 01.06.2027 Възраст: от 21 г.

Brazil University of Nove de Julho NCT06454006

Recruiting Phase 2

Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)

Acute Ischemic Stroke

The purpose of this study is to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset. Participants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. A total of 228 patients are planned in this study.

Начало: 31.07.2024 Край: 01.09.2027 Възраст: от 18 г. Prevention

Australia, Canada, United States Basking Biosciences, Inc. NCT06226805

Recruiting Phase 1/2

A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma

This is a phase 1/2 multicenter, open-label, first-in-human study of IBI3003. It includes a phase 1 dose escalation and expansion section to identify maximum tolerated dose(MTD)/recommended Phase 2 Dose(RP2D) of IBI3003, plans to enroll 23\~116 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma.

Начало: 29.07.2024 Край: 31.10.2027 Възраст: от 18 г. Treatment

Australia, China Innovent Biologics (Suzhou) Co. Ltd. NCT06083207

Recruiting

A Pilot Study Comparing Performance of Blind Participants on 12 Tasks, With and Without the ARIA Device

Blindness and Low Vision

Summary The environment in which we live, play and travel is primarily built by and for people with sight. Navigating the sighted world with blindness can be exhausting, as it involves disorientation, social isolation, increased risk, frustration and inefficiency. Accessing timely information about the environment is necessary to navigate an efficient path of travel and reduce the effort involved in living with blindness. Numerous assistive technologies have been developed to improve access to information, and quality of life for people with blindness, however persistent technology limitations include affordability, unreliable internet connection, lag and limited battery life. Existing technologies can offer scene description or text-to-voice quite effectively when the user is standing still, but not quickly enough to gain benefit when on the move. Timely information is crucial at road crossings, where poor decisions can result in injury. Information lag or deficit also compounds travel fatigue due to time and energy wasted in searching, uncertainty and frustration. Blind users are often brought in to test new technologies or devices in controlled, clinical conditions, when it is too late to influence design. There is little evidence of testing these technologies in lived environments to understand the functional benefits for the blind population, partly because there is a dearth of available methods and measures to embrace the complexity of functional research. This study will test the safety, efficacy and usability of the ARIA Device in 12 varied research tasks undertaken by blind participants in clinical, social and outdoor lived environments, comparing ARIA performance with each participant's ordinary (non-ARIA) methods of undertaking the same tasks. The study uses an embedded mixed methods design with a qualitative priority, generating rich, precise data about what matters to participants and what they can do in diverse situations.

Начало: 29.07.2024 Край: 21.12.2024 Възраст: от 18 г. Supportive care

Australia ARIA Research Pty Ltd NCT06477809

Recruiting Phase 2

A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression

Recurrent Ovarian Cancer Folate Receptor-Alpha Positive

The purpose of this study is to evaluate the incidence rate and severity of prespecified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer \[PSOC\] or platinum-resistant ovarian cancer \[PROC\]) with high folate receptor alpha (FRα) expression.

Начало: 29.07.2024 Край: 01.06.2027 Възраст: от 18 г. Treatment

Australia, Belgium, Canada +4 AbbVie NCT06365853

Recruiting Phase 3

A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis

Moderate to Severe Plaque Psoriasis Psoriatic Arthritis

The purpose of this study is to evaluate the effect of bimekizumab on gene expression biomarkers at Week 48 in a subset of study participants with moderate to severe plaque psoriasis (PSO) and moderate to severe plaque PSO with concomitant active psoriatic arthritis (PsA) who have provided skin biopsies for reverse transcription-polymerase chain reaction (RT-PCR).

Начало: 29.07.2024 Край: 14.03.2028 Възраст: от 18 г.

Germany, Poland, United States UCB Biopharma SRL NCT06506916

Recruiting Phase 1

Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors

Advanced Solid Tumors

The main goal of this first-in-human (FIH) study is to learn about the safety and dosing of GS-2121 when given alone or in combination with zimberelimab (ZIM) in participants with advanced solid tumors. The primary objectives of this study are: * To assess the safety and tolerability of GS-2121 as monotherapy and GS-2121 in combination with zimberelimab in participants with advanced solid tumors. * To identify the maximum tolerated dose (MTD) / maximum administered dose (MAD) and/or the recommended phase 2 dose (RP2D) of GS-2121 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.

Начало: 26.07.2024 Край: 01.06.2028 Възраст: от 18 г.

Canada, United States Gilead Sciences NCT06532565

Recruiting Phase 3

The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)

Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment

Начало: 26.07.2024 Край: 01.12.2030 Възраст: от 18 г. Treatment

Australia, New Zealand, United States Telix Pharmaceuticals (Innovations) Pty Limited NCT06520345

Recruiting

RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous NSCLC After Failure of Platinum-based Chemotherapy in Brazil

Non-squamous Non-Small Cell Lung Cancer

The study will be implemented as a retrospective, noninterventional medical record review of patients from routine practice settings who have been diagnosed with a/m non-squamous NSCLC with or without AGA and received at least 1 line of systemic treatment after failing PTC between January 2017 and December 2024.

Начало: 25.07.2024 Край: 30.06.2026 Възраст: от 18 г.

Brazil AstraZeneca NCT06491862

Recruiting Phase 3

A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)

Cervical Cancer

This study will have two phases: a sacituzumab tirumotecan safety run-in and a Phase 3 portion. The safety run-in phase will be used to evaluate the efficacy and safety of sacituzumab tirumotecan at the dose for evaluation in the Phase 3 portion. The purpose of this study is to compare the efficacy and safety of sacituzumab tirumotecan versus treatment of physician's choice as second-line treatment for participants with recurrent or metastatic cervical cancer in the Phase 3 portion. The primary study hypotheses are that, in the Phase 3 portion, sacituzumab tirumotecan results in a superior overall survival compared to TPC in participants with high trophoblast cell surface antigen 2 (TROP2) expression level and in all participants.

Начало: 24.07.2024 Край: 15.06.2028 Възраст: от 18 г. Treatment

Argentina, Australia, Austria +29 Merck Sharp & Dohme LLC NCT06459180

Recruiting Phase 1

A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors

Metastatic Hepatocellular Carcinoma Local Advanced Hepatocellular Carcinoma Alpha-fetoprotein (AFP)-Producing Gastric Cancer Extragonadal Yolk Sac Tumors +1

This is a first-in-human (FIH) clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of BGB-B2033 administered as monotherapy and in combination with tislelizumab, with or without bevacizumab. The study will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors/non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC).

Начало: 23.07.2024 Край: 31.12.2026 Възраст: от 18 г. Treatment

China, New Zealand, Puerto Rico +2 BeOne Medicines NCT06427941

Recruiting Phase 1

An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors

Advanced Solid Tumors

The primary objectives of this trial are to: * Characterize the safety and tolerability of TEV-56278 * Determine the Recommended Phase 2 Dose (RP2D) * Evaluate antitumor activity of TEV-56278 * Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab * Determine a RP2D of TEV-56278 in combination with pembrolizumab The secondary objectives of this trial are to: * Characterize the serum pharmacokinetics of TEV-56278 * Evaluate the antitumor activity of TEV-56278 * Determine the safety and tolerability of TEV-56278 * Evaluate other measures of antitumor activity of TEV-56278 * Evaluate anti-tumor activity Participants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion. The total duration of the trial will be up to 25 months for individual participants.

Начало: 22.07.2024 Край: 25.02.2031 Възраст: от 18 г.

Canada, United States Teva Branded Pharmaceutical Products R&D LLC NCT06480552

Recruiting Phase 3

Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial

Advanced Lung Non-Small Cell Carcinoma Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8

This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.

Начало: 19.07.2024 Край: 01.06.2026 Възраст: от 70 г.

United States National Cancer Institute (NCI) NCT06096844

Recruiting Phase 2

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART6043 Administered Orally as Monotherapy and in Combination to Patients with Advanced or Metastatic Solid Tumors

Metastatic solid tumors Advanced solid tumors

Trial status: Authorised Part B2: Incidence and severity of Adverse events (CTCAE v5.0), Best overall response (BOR), Objective Response Rate (ORR), Disease control rate (DCR), Duration of response (DOR) and change in tumor size, Serological tumor markers, Part A: Progression free survival (PFS), Overall survival (OS), ART6043 and ART7276 plasma concentration data, Olaparib plasma concentration data, Archival tumor or pre-dose tumor biopsy Part A: Incidence of Dose Limiting Toxicities (DLTs); incidence and severity of Adverse Events (CTCAE v5.0), Part B2: Progression free survival (PFS) (based on RECIST v1.1)

Начало: 19.07.2024 Възраст: от 18 г.

Spain Artios Pharma Limited 2023-509220-17-00

Recruiting

Multi-speed Ergonomic Wheelchair

Spinal Cord Diseases Spinal Cord Injuries

Over one million Americans rely on their upper extremities for manual wheelchair propulsion. Shoulder overuse injuries are prevalent among manual wheelchair users and these injuries often result in shoulder pain. Severe shoulder pain can lead some wheelchair users to transition from manual to powered mobility, complicating transportation, and reducing independence in activities of daily living. This project will expand the understanding of a new wheelchair design that allows better positioning of the hand rims and allows for different gearing. The investigators will study steady-state propulsion efficiency with different gear ratios and develop a new system with multiple gear ratios. The advanced gearing will allow for a low gear when initiating movement, going uphill, or when moving over carpet, and then a higher gear option for movements on hard flat level terrain. This system has the potential to dramatically improve shoulder ergonomics and reduce pain in many future manual wheelchair users.

Начало: 18.07.2024 Край: 31.03.2027 Възраст: от 18 г.

United States VA Office of Research and Development NCT05776030

Recruiting

Digital diagnoSis of Cardiac sOUNd in peDiatric Patients [DI-SOUND Study]

Cardiac Disease Auscultation of Heart Machine Learning

Neonatal screening procedures for potentially life-threatening congenital cardiovascular diseases (i.e., duct-dependent systemic or pulmonary circulation), currently implemented at the national level, rely primarily on cardiovascular physical examination performed by a neonatologist. More recently, this approach has been complemented by the assessment of hemoglobin oxygen saturation at both the upper and lower extremities (pre- and post-ductal saturation) in order to improve diagnostic sensitivity, although this practice has not yet been uniformly adopted nationwide. Converging evidence indicates that these screening strategies are affected by significant limitations in both sensitivity (failure to identify affected individuals) and specificity (false-positive findings in healthy subjects). These limitations are associated with substantial overall costs for the healthcare system. Failure to correctly identify affected neonates may result in increased morbidity and mortality, whereas overdiagnosis leads to unnecessary second-level diagnostic investigations and imposes a considerable psychological burden on families, who remain understandably anxious until diagnostic confirmation is achieved. The aim of the present research project (proof-of-concept study) is to develop a digital classifier capable to categorize heart sounds with commercially available digital stethoscopes into a binary classification system distinguishing physiological from pathological sounds. The derivation phase will be followed by a prospective validation phase, in which the classifier will be applied to assess its diagnostic performance. This phase will also evaluate the economic impact of the digital screening approach compared with standard practice. During the derivation phase, neonates with known cardiovascular status, as determined by prior echocardiographic assessment (including both healthy subjects and those with congenital heart disease), will be enrolled. Heart sounds will be recorded in a quiet environment under standard clinical conditions, without sedation. Digital recordings will be stored in WAV format and analyzed to develop a binary classification algorithm capable of distinguishing healthy from pathological cases. Following development, the classifier will be prospectively applied to a validation cohort of neonates undergoing conventional cardiovascular screening (clinical examination and pre- and post-ductal pulse oximetry), followed by classification using the digital tool under investigation. All participants will subsequently undergo confirmatory echocardiography. Diagnostic performance metrics, including sensitivity, specificity, positive and negative predictive values, and likelihood ratios, will be calculated for both the digital and conventional screening modalities. Furthermore, the number of missed pathological cases and the number of unnecessary second-level investigations resulting from false-positive findings will be used to define the economic benefit profile of the proposed screening strategy. Monte Carlo simulation techniques will be employed to extrapolate these findings at the national level, using ISTAT data on birth rates and disease prevalence. It is anticipated that the development of a digital classifier for the binary classification of neonatal heart sounds will be feasible. Moreover, it is expected that this tool will demonstrate superior diagnostic performance compared with current neonatal screening strategies, with beneficial implications not only for the accurate identification of affected and healthy neonates but also for reducing overall healthcare costs associated with missed diagnoses and inappropriate overdiagnosis.

Начало: 18.07.2024 Край: 01.01.2027 Възраст: 7–30 г.

Italy IRCCS Azienda Ospedaliero-Universitaria di Bologna NCT07542509

Recruiting Phase 2

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Inflammatory Bowel Diseases Crohn's Disease

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

Начало: 18.07.2024 Край: 01.06.2030 Възраст: 18–85 г. Treatment

Australia, Brazil, Bulgaria +22 Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of NCT06226883

Recruiting Phase 1

A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)

Locally Advanced Solid Tumor Metastatic Solid Tumor

Phase 1a/1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in participants with advanced or metastatic human epidermal growth factor receptor 2 (HER2) -altered non-small lung cancer (NSCLC). Phase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD. Phase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL-330 in participants with advanced or metastatic HER2 mutant NSCLC.

Начало: 18.07.2024 Край: 01.02.2027 Възраст: от 18 г. Treatment

Australia, Canada, United States Nuvalent Inc. NCT06521554

Recruiting Early Phase 1

Safety and Efficacy of Mesenchymal Stem Cells Associated With Chronic Pancreatitis Pain

Chronic Pancreatitis Chronic Pain

This protocol aims to test whether an infusion of allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSCs) can reduce pain associated with chronic pancreatitis (CP) and explore potential mechanisms of MSC action.

Начало: 17.07.2024 Край: 01.06.2028 Възраст: 18–75 г.

United States Medical University of South Carolina NCT06205342

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