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Recruiting Phase 2

Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma

Endometrial Neoplasms Neoplasm Recurrence, Local Neoplasm Metastasis

The goal of this clinical trial is to evaluate the efficacy and safety of cadonilimab in combination with paclitaxel, cisplatin, and radiation therapy for the treatment of locally recurrent and oligometastatic endometrial carcinoma. The main questions it aims to answer are: 1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants? 2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy? Participants will: * Receive cadonilimab, paclitaxel, cisplatin, and radiation therapy according to a specified protocol. * Visit the clinic for regular checkups and tests throughout the treatment period. * Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety. * Provide hematologic and tissue samples to explore biomarkers. This study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic endometrial carcinoma, as well as identify biomarkers to better guide treatment strategies.

Начало: 13.06.2024 Край: 01.09.2026 Възраст: 18–80 г.

China Shandong Cancer Hospital and Institute NCT06532539

Recruiting Phase 2

Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Mantle Cell Lymphoma

This phase II trial tests the safety and effectiveness of glofitamab given in combination with pirtobrutinib in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Obinutuzumab may also reduce the risk of immune-related conditions from treatment. Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the protein that signals cancer cells to multiply. Giving glofitamab in combination with pirtobrutinib may be safe, tolerable and/or effective in treating patients with relapsed or refractory mantle cell lymphoma.

Начало: 11.06.2024 Край: 31.07.2028 Възраст: от 18 г.

United States University of California, San Francisco NCT06252675

Recruiting Phase 3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs). The primary hypotheses of this study is that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to overall survival (OS).

Начало: 11.06.2024 Край: 14.06.2030 Възраст: от 18 г.

Argentina, Canada, China +16 Merck Sharp & Dohme LLC NCT06305754

Recruiting Phase 2

IVIG for Infection Prevention After CAR-T-Cell Therapy

Hematologic Malignancies

This phase II trial compares the effects of immunoglobulin replacement therapy with a placebo for preventing infectious complications in patients receiving CD19 chimeric antigen receptor (CAR)-T cell therapy. Hypogammaglobulinemia is a common complication in patients who receive CD19 CAR-T cell therapy. This is a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is high. Immunoglobulin replacement therapy works by replacing the body's immunoglobulin G (IgG) antibodies with donor blood product derived IgG antibodies that may help prevent infection. IgG antibodies are often depleted as a result of CAR-T therapy. Giving immunoglobulin replacement therapy may prevent infectious complications in patients receiving CD19 CAR-T cell therapy.

Начало: 10.06.2024 Край: 31.07.2028 Възраст: от 18 г.

United States Fred Hutchinson Cancer Center NCT05952804

Recruiting Phase 2

Lysergic Acid Diethylamide (LSD) in Palliative Care

Palliative Care Pain Anxiety Depression +6

Background: Terminally ill patients often experience significant psychosocial distress having depressed mood, death anxiety, pain, and an overall poor quality of life. Recent evidence from pilot studies suggests that serotonergic hallucinogens including lysergic acid diethylamide (LSD) and psilocybin produce significant and sustained reductions of depressive symptoms and anxiety, along with increases in quality of life, and life meaning in patients suffering from life-threatening diseases. Additionally, serotonergic hallucinogens may produce antinociceptive effects. Objective and Design: The study aims to evaluate effects of LSD on psychosocial distress in 60 patients suffering from an advanced or end-stage fatal disease with a life expectancy ≥12wks and ≤2yrs in an active placebo-controlled double-blind parallel study. Patients will be allocated in a 2:1 ratio to one of the two intervention arms receiving either two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of LSD (25 µg and 25 µg) as active-placebo control.

Начало: 09.06.2024 Край: 01.05.2028 Възраст: от 22 г.

Switzerland University Hospital, Basel, Switzerland NCT05883540

Recruiting

ADOLESCENTS IMAGING USING fMRI: Feasibility Study

Diagnosis of BPD Based on the DIB-R Clinical Interview for the BPD Group Diagnosis of ADHD Using the KSADS-PL for the ADHD Group Absence of Pathology on the CBCL and Ab-DIB for the Healthy Control Group All Participants Were Euthymic at the Time of Task Administration

Impaired social cognition and cognitive control associated with borderline personality disorder (BPD) remain less explored. Recent Franco-Canadian study, has shown the feasibility of a neuroimaging tests in Quebec adolescents with BPD. This study aims to increase knowledgements related to neural correlates of BPD and clinical disorders.

Начало: 08.06.2024 Край: 31.12.2027 Възраст: 12–17 г.

France Etablissement Public de la Sante Mentale de la Somme NCT07540429

Recruiting Phase 3

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)

Crohn's Disease

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\

Начало: 05.06.2024 Край: 12.11.2029 Възраст: 16–80 г. Treatment

Australia, Austria, Belgium +44 Merck Sharp & Dohme LLC NCT06430801

Recruiting

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

Recruiting

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

Recruiting Phase 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

Recruiting Phase 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. Treatment

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

Recruiting

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

Recruiting

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

Recruiting

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

Recruiting

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

Recruiting Early Phase 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

Recruiting

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

Recruiting Phase 2

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Mantle Cell Lymphoma

To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL.

Начало: 29.05.2024 Край: 01.03.2027 Възраст: от 18 г.

United States M.D. Anderson Cancer Center NCT06263491

Recruiting Phase 3

ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients

Breast Carcinoma

Eclectic is a strategy trial; once the class of treatment (endocrine therapy or chemotherapy) has been allocated according to 16α-18F-fluoro-17β-oestradiol (18F-FES) Positron Emission Tomography/Computed Tomography (PET/CT) results and circulating tumor biomarkers, clinicians will decide which treatment to use.

Начало: 27.05.2024 Край: 27.09.2030 Възраст: от 18 г.

France Institut Curie NCT06195709

Recruiting

The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy

Epilepsy

Neuronostics plan a prospective multisite trial to determine the clinical utility of BioEP in the context of diagnostic decision making. Neuronostics will use findings from the trial to improve user experience of the Neuronostics platform (the tool which clinicians use to obtain a BioEP score from EEG and the aligned report). The data coming from the trial will also enable Neuronostics to iterate the BioEP algorithms and so improve future performance.

Начало: 21.05.2024 Край: 31.12.2026 Възраст: от 18 г.

United Kingdom Neuronostics Ltd NCT06097195

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