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Набира участници Фаза 1/2

Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma

B-cell Lymphoma Recurrent B-cell Lymphoma Refractory CNS Metastases

Secondary involvement of the central nervous system (CNS), such as CNS relapse after treatment or progression during treatment, is a rare but deadly occurrence in patients with B-cell non-Hodgkin lymphoma (NHL), particularly in cases of diffuse large B-cell lymphoma (DLBCL) and transformed follicular lymphoma (FL). Despite the grim prognosis associated with secondary CNS involvement, no definitive treatment strategy exists. Selinexor®, an oral, first-in-class, potent selective inhibitor of nuclear export that binds to XPO1, leads to the nuclear retention of tumor suppressor and growth regulator proteins, as well as topoisomerase II enzymes, thereby restoring their functions. Preclinical studies have also shown that selinexor can sensitize cancer cells to topoisomerase inhibitors, alkylating agents, and steroids. Selinexor has been approved by the Food and Drug Administration for relapsed or refractory DLBCL. We hypothesize that selinexor could work synergistically with ifosfamide (an alkylating agent) and etoposide (a topoisomerase II inhibitor) in the ifosfamide, carboplatin, and etoposide (ICE) regimen. High-dose dexamethasone was added to this regimen to enhance the efficacy of ICE as a salvage regimen for secondary CNS involvement, due to its ability to cross the blood-brain barrier. This phase I/II study aims to evaluate the efficacy and safety of selinexor in combination with ifosfamide, carboplatin, etoposide (ICE), and dexamethasone in patients with relapsed or refractory B-cell non-Hodgkin lymphoma with secondary CNS involvement.

Начало: 01.05.2024 Край: 30.12.2028 Възраст: от 18 г.

South Korea Samsung Medical Center NCT06552559

Набира участници Фаза 2

A Study of Avutometinib, Defactinib, and Letrozole in People With Low-Grade Serous Ovarian Cancer

Low-Grade Serous Ovarian Cancer

The researchers are doing this study to find out whether the combination of avutometinib, defactinib, and letrozole is an effective treatment for people with low-grade serous ovarian cancer (LGSOC). The researchers will also look at the safety of this combination.

Начало: 29.04.2024 Край: 01.04.2027 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT06394804

Набира участници Фаза 3

A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.

Начало: 29.04.2024 Край: 01.03.2028 Възраст: от 12 г.

Argentina, Belgium, Bulgaria +17 Eli Lilly and Company NCT06338995

Набира участници Фаза 1/2

A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

Malignant Neoplasm

The study is a first-in-human (FIH), open-label, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors. This study will consist of a phase 1 dose escalation part and phase 2 dose expansion part. This study will evaluate the efficacy of TSN1611 at RP2D(s) through ORR using RECIST version 1.1, and determine and confirm the MTD/RP2D for TSN1611 in combination with cetuximab, in combination with cetuximab and mFOLFOX6, in combination with gemcitabine and albumin-bound paclitaxel in subjects with selected solid tumors.

Начало: 29.04.2024 Край: 30.04.2027 Възраст: 18–75 г.

China, United States Tyligand Pharmaceuticals (Suzhou) Limited NCT06385925

Набира участници Фаза 2

The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures

Disease or Disorder

This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port \[SP\]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.

Начало: 26.04.2024 Край: 13.10.2026 Възраст: от 18 г.

United States City of Hope Medical Center NCT05672368

Набира участници Фаза 3

A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)

Perennial Allergic Rhinitis (PAR)

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. Participants can expect study participation to last up to 29.5 months.

Начало: 26.04.2024 Край: 01.10.2028 Възраст: от 18 г.

Belgium, China, Germany +3 Eli Lilly and Company NCT06339008

Набира участници Фаза 2

Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma

Esophageal Adenocarcinoma Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

The goal of this study is to learn about of the research study drug, telomelysin (OBP-301), in combination with pembrolizumab in advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. The main question it aims to answer is whether this combination is safe and effective in this type of cancer. Participants will receive 5 injections of OBP-301, approximately every 2 weeks. OBP-301 will be injected directly into the tumor during an esophagogastroduodenoscopy (EGD). At the same time as the injection, a tumor biopsy will be taken. Participants will also receive pembrolizumab infusions every 6 weeks until disease progression or for a maximum of two years. Pembrolizumab infusions will occur on different days than OBP-301 injections.

Начало: 25.04.2024 Край: 01.04.2030 Възраст: от 18 г.

United States Weill Medical College of Cornell University NCT06340711

Набира участници

Liberation From Mechanical Ventilation Using Extubation Advisor Decision Support

Airway Extubation

Timely and safe extubation in critically ill patients is vitally important as prolonged mechanical ventilation and failed attempts at extubation are associated with increased morbidity, mortality, costs, intensive care unit (ICU) stays, and a risk for aerosolization of COVID-19 to health care providers. A Spontaneous Breathing Trial (SBT) is the current standard of care to assess a patient's readiness for extubation. However, SBTs are performed in various ways and have poor ability to predict successful extubation on their own. There is an urgent need to improve and standardize extubation decision-making. In a prior multicenter study, the investigators showed that decreased respiratory rate variability during SBTs predicted extubation failure better than other predictive indices. The Extubation Advisor (EA) tool combines clinician's assessments of extubation readiness with predictive analytics and risk mitigation strategies for individual patients. In a single centre observational study, the investigators demonstrated the ability to deliver EA reports to the bedside and acceptability of this decision-support tool to respiratory therapists (RTs) and physicians (MDs). The investigators will conduct the Liberation from mechanical ventilation using EA Decision Support (LEADS) Pilot Trial to assess feasibility outcomes. They will include critically ill adults who are invasively ventilated for \>48 hours and are ready to undergo an SBT. Patients in the intervention arm undergo an EA assessment and treating clinicians (RTs, MDs) will receive an EA report for each SBT conducted. The EA report will help to guide extubation decision-making. Patients in the control arm receive standard care. SBTs will be directed by clinicians. The primary feasibility outcome will reflect the ability to recruit the desired population. The investigators will also assess the usefulness of the tool to MDs and complete an analysis of resource utilization to inform future economic analyses of cost-effectiveness. The investigators aim to recruit 1 to 2 patients/month/center. The LEADS trial is novel and low-risk. It is the first trial to evaluate use of a bedside decision support tool to assist ICU clinicians with extubation decision-making. The LEADS pilot trial will inform the design of a future, large-scale randomized controlled trial that is expected to enhance the care delivered to critically ill patients, improve extubation outcomes, and inform extubation practice in ICUs.

Начало: 22.04.2024 Край: 31.12.2026 Възраст: от 18 г.

Canada Ottawa Hospital Research Institute NCT05506904

Набира участници Фаза 3

Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma

Ganglioneuroblastoma, Nodular Neuroblastoma

This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.

Начало: 19.04.2024 Край: 31.12.2029 Възраст: до 30 г. Лечение

Australia, Canada, New Zealand +1 National Cancer Institute (NCI) NCT06172296

Набира участници Фаза 2

Multicenter Trial of ESK981 in Patients With Select Solid Tumors

Pancreatic Adenocarcinoma Adenosquamous Carcinoma Pancreatic Neuroendocrine Tumor Pancreatic Neuroendocrine Carcinoma +3

This protocol will enroll patients with pancreatic adenocarcinoma and adenosquamous carcinoma (Cohort 1), gastrointestinal/pancreatic neuroendocrine neoplasms with Ki-67 \> 20% (Cohort 2) and neuroendocrine prostate carcinoma (Cohort 3)). Each cohort will have its own interim analysis after enrollment of 10 patients. Subjects will be given a one-month (28 day) supply of study drug (ESK981). Subjects will be instructed to take 4 capsules, with or without food, once per day for 5 consecutive calendar days, then take a drug holiday for 2 consecutive days before repeating the 5 days on-2 days off cycle in sets of 4 weeks or 28 calendar days. Subjects will be asked to keep a pill diary noting the date they take their study drug.

Начало: 19.04.2024 Край: 01.04.2029 Възраст: от 18 г.

United States University of Michigan Rogel Cancer Center NCT05988918

Набира участници

Pre-operative Hypofractionated Proton Therapy

Soft Tissue Sarcoma

This study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. As part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. The study will measure wound complications and functional outcomes / quality of life after the procedures. Patients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. Otherwise, the participants will have standard of care follow ups with the treatment team.

Начало: 18.04.2024 Край: 01.12.2032 Възраст: от 18 г.

United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopk NCT05917301

Набира участници Фаза 2

A Study of BV-AVD in People With Bulky Hodgkin Lymphoma

Hodgkin Lymphoma

The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease. BV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer.

Начало: 17.04.2024 Край: 01.04.2027 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT06377566

Набира участници

Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment of G/GEJ Adenocarcinoma

Gastric Cancer

To explore the efficacy and safety of fruquintinib and albumin-paclitaxel combined with or without PD-1 antibody in the second-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma that failed to be treated by anti-PD-1 /PD-L1 regimen

Начало: 15.04.2024 Край: 30.12.2026 Възраст: от 18 г.

China Cancer Institute and Hospital, Chinese Academy of Medic NCT06417892

Набира участници

Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy

Pregnancy Iron Deficiency

This two-arm, double-blind randomized clinical trial will recruit 172 generally healthy, low-risk pregnant individuals aged 19-42 years living in Vancouver, Canada. Participants will be randomized to receive one of two forms of iron (ferrous fumarate or ferrous bisglycinate) in addition to a prenatal multivitamin (without iron) daily during their pregnancy until delivery, with optional continuation until \~4 weeks postpartum for breastmilk sample collection. Blood samples will be taken at baseline (13-25 weeks gestation) and follow-up (35-37 weeks gestation) to assess how different forms of iron impact body iron stores. Stool samples will be obtained within 1 week of both baseline and follow-up visits to assess changes in gut microbiome composition. This research will inform more specific guidelines for optimal iron supplementation practices for the prevention and treatment of iron deficiency for both mother and baby.

Начало: 12.04.2024 Край: 01.01.2027 Възраст: 19–42 г.

Canada University of British Columbia NCT06014983

Набира участници

Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Behavior Hyperactive Behavior Disorders

The ADA cohort aims for the systematic and standardized collection of sociodemographic, clinical and neuropsychological data, during 2 visits (inclusion and 12 months), from patients suffering from the co-occurrence of ADHD (Attention Deficit Hyperactivity Disorder) and addiction(s), in addition to the treatment as usual adapted to each situation.

Начало: 11.04.2024 Край: 31.12.2026 Възраст: 18–99 г.

France Nantes University Hospital NCT06232226

Набира участници Фаза 3

Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Small Vessel Stroke

Ischemic Stroke

Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever small vessel stroke patients treated with clopidogrel and aspirin assessed through NIHSS, mRS, and possible adverse effects.

Начало: 10.04.2024 Край: 30.05.2026 Възраст: 18–75 г.

Egypt Kafrelsheikh University NCT06358313

Набира участници

Mindfulness-Based fMRI Neurofeedback for Depression

Depression in Adolescence Rumination

In the United States, adolescents experience alarmingly high rates of major depression, and gold-standard treatments are only effective for approximately half of patients. Rumination may be a promising treatment target, as it is well-characterized at the neural level and contributes to depression onset, maintenance, and recurrence as well as predicts treatment non-response. Accordingly, the proposed research will investigate whether an innovative mindfulness-based real-time functional magnetic resonance imaging (fMRI) neurofeedback intervention successfully elicits change in the brain circuit underlying rumination to improve clinical outcomes among depressed adolescents.

Начало: 10.04.2024 Край: 30.06.2027 Възраст: 13–18 г.

United States Columbia University NCT05617495

Набира участници Фаза 1

A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors

Oncology MEK Mutation RAF Gene Mutation Ras (KRAS or NRAS) Gene Mutation +5

This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated/dependent advanced solid tumors who have exhausted standard treatment options.

Начало: 09.04.2024 Край: 01.11.2029 Възраст: от 18 г. Лечение

Australia, United States Nested Therapeutics, Inc NCT06326411

Набира участници

Development and Validation of the Observatory Battery of Common Eye Disorders for Adults With Intellectual Disability

Intellectual Disability

Background: Around 15% of the global population has some form of disability. Rights to obtain proper health care is an emphasis in the United Nationals Convention on the Right of People with Disability. Due to the importance of improving vision health for people with disabilities, studies on how to identify vision problems becomes extremely important in policy formulation for all countries. Among all types of disabilities, people with intellectual disability (ID) are among the ones where vision problems are the hardest to detect. Currently, no caregiver assessable scales are available, as a result, adults with ID are at high risk of delayed diagnose for common ocular conditions. Objectives: This is a one-year project. The objective of this study is two folds: 1. To develop an item bank of ocular conditions of adults with ID; 2. To develop a scale for caregivers to detect ocular conditions for adults with ID, and to validate the reliability, construct validity and responsiveness of the scale.

Начало: 09.04.2024 Край: 31.12.2027 Възраст: от 20 г.

Taiwan National Taiwan University Hospital NCT06737627

Набира участници

Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.

Alcohol Drinking Pregnancy

The effects of alcohol consumption during pregnancy have been known for decades. However, alcohol consumption in pregnant women remains today a public health problem and its identification is primordial. During pregnancy, standardized self-reports such as T-ACE would help identify early women with high-risk alcohol consumption. T-ACE appears to be one of the most used during pregnancy but its diagnostic value is not objectively known. To evaluate the diagnostic value of T-ACE self-report in the detection of high-risk alcohol consumption during pregnancy, by comparison with the dosage of a biomarker in blood. Material and methods Multicentric diagnostic prospective study of 2425 pregnant women followed in 3 hospitals of North of France. The self-report will be offered to all women during their prenatal consultation in these 3 maternity clinics. When they returned their self-report to the medical practitioner, a unique blood test of phosphatidylethanol will be proposed to them for a period of one year. Made after informed consent, this dosage will be used as a gold standard of an alcohol consumption during the previous three weeks to establish the diagnostic value of T-ACE. An alcohol consumption will be considered " at high risk " if blood phosphatidylethanol is ≥ 20 µg/L. With a predictable 25% rejection rate and a positive 4% T-ACE frequency, the inclusion of 2425 patients should permit to estimate sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of T-ACE with a satisfactory 95% confidence interval in this population. The evidence of a link between positive T-ACE and real high-risk alcohol consumption in pregnant women would objectively validate the use of this self-report during pregnancy. The T-ACE within the self-report (self-administered questionnaire) set up in these 3 maternity hospitals in the North of France is already a reference thanks to its several advantages to better identify psychosocial risk situations and especially high-risk alcohol consumption during pregnancy than medical history. If T-ACE appeared to be a sensitive and specific method for identifying high-risk alcohol use during pregnancy, it could be generalized in the follow-up of pregnant women in our country.

Начало: 08.04.2024 Край: 01.04.2027 Възраст: от 18 г.

France University Hospital, Lille NCT04786587

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