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Набира участници

Prospective Clinical Assessment Study in Children With Hypochondroplasia

Hypochondroplasia

This is a long-term, multicenter, non-interventional study of children ages 2.5 to \

Начало: 05.06.2024 Край: 01.10.2026 Възраст: 30–16 г.

Australia, Canada, France +7 QED Therapeutics, a BridgeBio company NCT06410976

Набира участници Фаза 3

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Advanced Melanoma

This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.

Начало: 05.06.2024 Край: 16.10.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +19 Immunocore Ltd NCT06112314

Набира участници Фаза 1

A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS

Acute Myeloid Leukemia Refractory Myelodysplastic Syndrome Acute Myeloid Leukemia Myelodysplastic Syndrome With Excess Blasts Acute Myeloid Leukemia, in Relapse +1

This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB).

Начало: 04.06.2024 Край: 01.05.2027 Възраст: от 18 г. Лечение

Australia, United Kingdom Apollo Therapeutics Ltd NCT06372717

Набира участници

Prevalence of Dissociative Identity Disorder in At-risk Outpatient Groups Reporting Childhood Trauma.

Dissociative Disorder

The investigators will study the prevalence of dissociative identity disorder (DID) in three populations at risk in cases of childhood psychotrauma : patients with a diagnosis of borderline personality, patients with a diagnosis of functional dissociative crises (FDC) and patients with early psychosis. The investigators will also study the prevalence of other dissociative disorders and the frequency of complex post-traumatic stress disorder. The investigators will also look for correlations between the type of maltreatment in childhood, the age of onset of trauma and the type of diagnosis of dissociative disorders. The investigators hope to include 150 borderline patients, 150 FDC patients and 50 early psychosis patients. Data collection will be done via a psychometric administration of 7 self-completion questionnaires as well as the completion of the SCID-D semi-structured interview.

Начало: 04.06.2024 Край: 18.08.2026 Възраст: от 18 г.

France Centre Psychothérapique de Nancy NCT06330467

Набира участници

Collaborative Care Model for Perinatal Wellness Support Services - Population-Level Equity-Centered Systems Change

Perinatal Mental Health

The collaborative care model (CCM) is a health services intervention that integrates mental health care in primary care settings. The goal of this study is to adapt the CCM to the perinatal care context, including community co-designed adaptations to enhance health equity (COMPASS+). The main objectives of the study are to: 1. Evaluate the effect of COMPASS+ on depression symptom outcomes. Specifically we will evaluate population-level depression symptom trajectories and the prevalence of suicidal ideation among. We will also measure rates of depression response and remission for those who have elevated screen scores (i.e., PHQ9 ≥ 10) 2. Adapt, optimize, and evaluate COMPASS+ implementation strategies to the unique context of perinatal care and evaluate implementation outcomes. The RE-AIM framework will be used to evaluate implementation outcomes (acceptability, appropriateness, feasibility, and fidelity). We hypothesize that variability in effectiveness outcomes will be attributable to variability in fidelity to the implementation strategies or in implementation outcomes. 3. Identify the effect of COMPASS+ on perinatal depression and implementation outcomes across racial and ethnic subgroups.

Начало: 03.06.2024 Край: 30.06.2028 Възраст: от 18 г.

United States Women and Infants Hospital of Rhode Island NCT06849869

Набира участници Фаза 2

Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial

Recurrent Castration-Sensitive Prostate Carcinoma Recurrent Prostate Cancer Castration-resistant Prostate Cancer Biochemically Recurrent Prostate Carcinoma

This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). It also studies the effects of salvage radiation therapy (sXRT) on prostate cancer and to see if radiation to the pelvis helps prevent prostate cancer from spreading elsewhere. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. sXRT is a targeted radiation treatment for the prostate, typically given when cancer possibly returns after surgery or radiation. Its goal is to destroy any tumor cells in the area. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT and sXRT may be effective in treating prostate cancer and preventing it from spreading elsewhere.

Начало: 03.06.2024 Край: 28.02.2031 Възраст: от 18 г.

United States Mayo Clinic NCT06378866

Набира участници Фаза 3

A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Obesity Weight Gain

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits. Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

Начало: 03.06.2024 Край: 01.12.2030 Възраст: 12–17 г. Лечение

Argentina, Australia, Canada +9 Eli Lilly and Company NCT06439277

Набира участници Фаза 3

Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Myelofibrosis Post-PV MF Post-ET Myelofibrosis Primary Myelofibrosis +1

This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.

Начало: 03.06.2024 Край: 31.12.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Croatia +14 Kartos Therapeutics, Inc. NCT06479135

Набира участници Ранна Фаза 1

177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors

PDL1 Gene Mutation Non Small Cell Lung Cancer Small Cell Lung Cancer ( SCLC ) TNBC, Triple Negative Breast Cancer +5

This is a Phase 0/1, First-in-Human (FIH), study to evaluate safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD204 in participants with selected solid tumours, to identify the MTDs/ recommended doses of 177Lu-RAD204 for future exploration. The study will consist of a Pre-screening Period (if applicable for PD-L1 testing), a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and dosimetry to 177Lu-RAD204im and a Phase I (Treatment) Period for 177Lu-RAD204tr dose escalation.

Начало: 03.06.2024 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia Radiopharm Theranostics, Ltd NCT06305962

Набира участници

A Randomised Clinical Trial of a Digital Self-management Package for People With Interstitial Lung Disease

Lung Diseases, Interstitial Pulmonary Fibrosis

The goal of this clinical trial is to compare REBUILD-SM (a purpose-built smartphone app and self-management package) with standard care in people with interstitial lung disease (ILD). The main question it aims to answer is: • Does REBUILD-SM improve health-related quality of life, symptoms, anxiety, self-efficacy and physical activity for people with ILD? Participants in the intervention group will work through the self-management package with support from a healthcare professional via phone or Zoom. They will also enter deidentified health data into the RE-BUILD smartphone app to track their progress over time. Participants in the control group will use a reduced functionality version of the smartphone app only. Researchers will compare both groups to see if there is any difference in health-related quality of life, symptoms, anxiety, self-efficacy and level of physical activity.

Начало: 03.06.2024 Край: 01.08.2027 Възраст: от 18 г. Поддържаща грижа

Australia University of Sydney NCT06122233

Набира участници Фаза 4

Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression

Treatment Resistant Depression

The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are: * How the two formulations compare in terms of their effectiveness in treating TRD. * How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness. Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes.

Начало: 03.06.2024 Край: 01.04.2027 Възраст: от 18 г. Лечение

Australia The George Institute NCT06278779

Набира участници

Arm Use With Soft-robotic Glove

Trauma Injury of Hand Multiple Neurologic Disorder

This study, aimed at investigating the impact of using a supportive soft-robotic glove on actual arm and hand use in daily life, is designed as a single-case experimental design study. 3-5 patients with limitations in hand function due to trauma-related or neurological conditions are asked to participate. Participants will be asked to use a soft-robotic glove at home for six weeks during daily activities relevant to them, while that glove supports the grip of their most affected hand. For several weeks before, during and after the use of the soft-robotic glove, participants will be asked to do some short tests (wearing an activity meter on both wrists during the day, performing a hand squeeze test under the supervision of the researcher via video call) and to answer some questions related to perceived hand function and well-being (a total of at least 15 times during 12-14 weeks). The present study is a follow-up to previous studies that investigated the effect of (previous versions of) the same robotic glove (Carbonhand; Bioservo Technolo-gies AB, Kista, Sweden) on hand function, in order to better understand and explain the observed therapeutic effect.

Начало: 03.06.2024 Край: 01.10.2026 Възраст: 18–90 г.

Netherlands Roessingh Research and Development NCT06033027

Набира участници

Pupil-Indexed Noninvasive Neuromodulation

Paresis

Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning.

Начало: 03.06.2024 Край: 05.08.2028 Възраст: 18–75 г.

United States VA Office of Research and Development NCT06282406

Набира участници

Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage

Intracerebral Hemorrhage Stroke Hypertension

The aim is to compare the rate of hypertensive subjects with ICH who reach SBP target with stability within 60 minutes of enrollment, among patients treated with IV clevidipine with those treated with alternate IV antihypertensive regimen.

Начало: 01.06.2024 Край: 30.07.2028 Възраст: 18–100 г.

United States Zeenat Qureshi Stroke Institute NCT06402968

Набира участници

Doppler Flow in Tubal Ectopic Pregnancy in Diagnosis as a Predictor of Treatment Success - Conservative and MTX Treatment

Ectopic Pregnancy

The study "Doppler Flow in Tubal Ectopic Pregnancy as a Predictor of Treatment Success: Conservative and MTX Therapy" aims to evaluate the role of Doppler ultrasound parameters (RI, PI, and PSV) in predicting treatment success for tubal ectopic pregnancies. Ectopic pregnancies, affecting \~2% of all pregnancies (98% in fallopian tubes), pose significant risks, including rupture and maternal mortality. Diagnosis is typically achieved via transvaginal ultrasound, with Doppler imaging enhancing accuracy by detecting characteristic vascular patterns. Management options include conservative monitoring, methotrexate (MTX) therapy, or surgery, based on clinical stability, β-hCG levels, and ultrasound findings. While β-hCG levels are a known predictor of MTX treatment failure, there is no consensus on an optimal threshold. Prior research suggests increased vascularization on Doppler ultrasound may correlate with higher MTX success rates. This prospective study will involve 60 women aged 18-45 with stable, unruptured tubal ectopic pregnancies. It will assess Doppler parameters and other clinical factors as predictors of treatment success. Findings aim to address gaps in the literature and improve management strategies for tubal ectopic pregnancies.

Начало: 01.06.2024 Край: 01.06.2027 Възраст: 18–45 г.

Israel Meir Medical Center NCT07541937

Набира участници Ранна Фаза 1

Nebulized Dexmedetomidine or Lidocaine for Treatment of Post Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia

Pain Score (VAS)

Post-dural puncture headache (PDPH) is a well-recognized and potentially serious complication of subarachnoid block. While advancements in spinal needle design have reduced its incidence in recent years, PDPH still affects a notable percentage of post-partum patients undergoing spinal anaesthesia, with rates ranging from 0.5% to 2%. Factors such as female gender, pregnancy, young age, low body mass index, dilutional anemia, and the preference for neuraxial anaesthesia during caesarean section (CS) increase the vulnerability of obstetric patients to PDPH. Therefore, managing this complication is critically important in obstetric anaesthesia. The exact cause of PDPH remains unclear, but there is substantial evidence suggesting that it stems from reduced cerebrospinal fluid (CSF) pressure due to continuous leakage through a dural tear, which exceeds the rate of CSF production. This imbalance can lead to PDPH, as even a modest loss of CSF volume (as little as 10%) can trigger traction on pain-sensitive intracranial structures when in an upright position, compounded by reflexive vasodilation. Various treatment strategies have been proposed, typically including bed rest in a supine position, fluid therapy, analgesics, and medications such as sumatriptan and caffeine. Dexmedetomidine (DEX) is a highly specific agonist of α2-adrenoreceptors known for inducing cooperative sedation, anxiolysis, and analgesia while minimizing respiratory depression. Additionally, it has been shown to mitigate the stress and inflammatory response triggered by surgical and anaesthetic procedures. Activation of α2-receptors in the substantia gelatinosa of the dorsal horn suppresses the firing of nociceptive neurons and inhibits the release of substance P. Furthermore, stimulation of these receptors in the locus coeruleus, a key modulator of nociceptive transmission, interrupts the transmission of pain signals, resulting in analgesia. Dexmedetomidine has been administered via intranasal and inhalational routes for various purposes, including premedication, sedation, and post-operative analgesia. Lidocaine nebulized is a novel method used recently for PDPH. Intranasal lidocaine can offer sphenopalatine ganglion block which can facilitate acute pain reduction in PDPH.

Начало: 01.06.2024 Край: 06.06.2026 Възраст: 20–40 г.

Egypt Minia University NCT06607861

Набира участници

Fibrinolysis Resistance in Infection and Trauma

Sepsis and Septic Shock Trauma

Blood coagulation disorders are often seen in critically ill patients e.g. with severe infection or following extensive injury, that can lead to life threatening events as a result of excessive blood clot formation leading to organ failure. This study aims to use Viscoelastic Testing (VET) technology to detect patients at risk of excessive blood blot formation at the bedside, test new blood coagulation drugs, and guide life-saving use of blood modifying treatments.

Начало: 01.06.2024 Край: 01.06.2026 Възраст: от 18 г.

Australia Anders Aneman NCT06680180

Набира участници Фаза 2/3

Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke

Ischemic Stroke, Acute Cerebrovascular Disorders Brain Disorder Central Nervous System Diseases

Multicentre, prospective, Multi-arm Multi-stage (MAMS) seamless phase 2b/3 interventional randomized placebo-controlled double-blinded parallel-assignment (2 arms with 1:1 randomization) efficacy and safety trial to test intra-arterial tenecteplase at the completion of thrombectomy versus best practice in participants with anterior circulation LVO receiving mechanical thrombectomy within 24 hours of symptoms onset.

Начало: 01.06.2024 Край: 30.11.2027 Възраст: от 18 г. Лечение

Australia University of Melbourne NCT05892510

Набира участници Фаза 2

A Randomised Controlled Trial, Of N-Acetyl Cysteine (NAC), for Premanifest Huntingtin Gene Expansion Carriers

Huntington Disease

NAC-preHD is a phase II randomized placebo controlled study of oral NAC among premanifest HD gene expansion carriers, with clinical and radiological outcome at three years.

Начало: 01.06.2024 Край: 01.05.2027 Възраст: от 18 г. Лечение

Australia Western Sydney Local Health District NCT05509153

Набира участници

Diagnostic Value of Deep Learning-Based Rapid MRI in Preoperative Evaluation of Acute Cholecystitis

Acute Cholecystitis

This is a single-center, prospective observational study at Peking Union Medical College Hospital. The main goal is to evaluate the image quality and clinical value of a new fast abdominopelvic MRI sequence that uses deep learning-based reconstruction. The study will include adult patients (18 years or older) who need an MRI scan of the abdomen or pelvis as part of their routine care. These patients will receive both the standard MRI sequence and the new fast sequence, with the goal of comparing the two. The fast sequence is designed to be shorter (5-8 minutes) while maintaining or improving image quality, which can help reduce patient discomfort and motion-related artifacts. Radiologists will assess the quality of the images from both sequences. The study will also look at how well the fast sequence can detect common abdominal and pelvic diseases, such as gallstones, inflammation, and tumors. This study does not involve new drugs, invasive procedures, or changes to standard care. No additional risks to patients are expected beyond those of a standard MRI scan.

Начало: 01.06.2024 Край: 31.12.2026 Възраст: от 18 г.

China Peking Union Medical College Hospital NCT07551375

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