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Набира участници Фаза 2

Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer

Metastatic Nasopharyngeal Carcinoma Recurrent Nasopharyngeal Carcinoma Stage IV Nasopharyngeal Carcinoma AJCC v8

This phase II trial tests how well nivolumab and ipilimumab immunotherapy with or without cabozantinib works in treating patients with nasopharyngeal cancer that has come back (after a period of improvement) (recurrent), has spread from where it first started (primary site) to other places in the body (metastatic), or for which no treatment is currently available (incurable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving immunotherapy with nivolumab and ipilimumab and targeted therapy with cabozantinib may help shrink and stabilize nasopharyngeal cancer.

Начало: 19.02.2024 Край: 16.06.2028 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT05904080

Набира участници Фаза 2

DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment

Ductal Carcinoma in Situ

The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease. Participants will be asked to receive control hormonal therapy or an investigational hormonal therapy treatment. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation participants will have the option to continue on the treatment. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care.

Начало: 17.02.2024 Край: 01.11.2033 Възраст: от 18 г.

United States QuantumLeap Healthcare Collaborative NCT06075953

Набира участници Ранна Фаза 1

Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503

Tauopathies

The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C-M503. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Parkinson's disease (PD). Investigators will compare uptake in participants with PD versus participants with multiple system atrophy (MSA) and progressive supranuclear palsy (PSP), as well as non-Parkinsonism volunteers. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt) (non-clinical site) Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites.

Начало: 16.02.2024 Край: 01.02.2029 Възраст: 40–85 г.

United States University of Pennsylvania NCT06303921

Набира участници

Online Support 4 CHD Kids & Caregivers

Congenital Heart Disease

This study will evaluate a virtual mental health parenting stepped-care intervention (I-InTERACT-North) to determine if the program works to improve positive parenting skills and child behaviour among families with children born with Congenital Heart Disease (CHD). Recruitment will target children ages 3-9 years old from SickKids. We will also evaluate the acceptability and feasibility of the program among children and families to inform future delivery and multi-site trials. Results will evaluate whether I-InTERACT-North can improve parenting and child behaviour in these families and inform future best clinical practices for this population.

Начало: 15.02.2024 Край: 31.12.2028 Възраст: 3–9 г.

Canada The Hospital for Sick Children NCT06075251

Набира участници Фаза 2

Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio

Bile Duct Cancer Cholangiocarcinoma Cholangiocarcinoma Non-resectable Cholangiocarcinoma Metastatic +1

This trial is designed to study a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for bile duct cancer that cannot be removed with surgery. The specific names of the interventions that will be used are: * Y-90 (a type of radiation microsphere bead) * Durvalumab (a type of immunotherapy) * Gemcitabine (a type of chemotherapy) * Cisplatin (a type of chemotherapy)

Начало: 13.02.2024 Край: 01.12.2027 Възраст: от 18 г.

United States Beth Israel Deaconess Medical Center NCT05655949

Набира участници

Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Upper Limb Function in Subacute Stroke Patients

Stroke

The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.

Начало: 13.02.2024 Край: 30.09.2026 Възраст: от 19 г.

South Korea Samsung Medical Center NCT06270238

Набира участници

Cognitive Function and Affective Regulation in Meditators

Cognitive Function and Affective Regulation

This is a prospective cohort study with 52 meditators and 52 controls. These groups will be contacted at a singular timepoint, during which they will take surveys and cognitive tests, which will be used to assess cognitive and emotional outcomes. The meditator group will be recruited from a pool of healthy individuals who have learned meditation practices such as those taught by the Isha Foundation (e.g., Shambhavi Mahamudra Kriya, Shoonya, Samyama breath-watching, etc.) Meditation-naïve individuals will be recruited into the control group.

Начало: 09.02.2024 Край: 31.12.2026 Възраст: от 18 г.

United States Balachundhar Subramaniam NCT07546786

Набира участници Фаза 3

The Role of Peripheral Afferents in Modulating Post-stroke Central Pain

Stroke

Central post-stroke pain (CPP) is extremely difficult to relieve and responds very poorly to analgesics targeting neuropathic pain, probably because the mechanisms underlying this pain remain poorly understood. Stroke pain is traditionally considered to be of central origin and related to changes in the spinal cord and/or brain nociceptive systems. However, a recent study in a small cohort of patients has suggested that the peripheral nervous system (PNS) may have a role in the initiation and persistence of APD. The main objective of this prospective randomised controlled bicentric study (Raymond Poincaré and Ambroise Paré) in double blind and parallel groups against placebo (3 arms) will be to evaluate the efficacy of two peripheral nerve blocks performed 14 days apart on spontaneous neuropathic pain after stroke. The active treatments used for the blocks will be either lidocaine 20 mg/ml or levobupivacaine 1.25 mg/ml or placebo (saline)

Начало: 09.02.2024 Край: 08.09.2026 Възраст: от 18 г.

France Institut National de la Santé Et de la Recherche Médica NCT06446960

Набира участници

Avocado Consumption, Nutrients in Human Milk, and Infant Cognitive Development

Breastfeeding, Exclusive

The goal of this interventional study is to establish a whole food, avocado, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. Eighty-eight breastfeeding dyads, 3m postnatal, will participate in this study designed to: 1. To document whether lactating mothers will comply in the consumption of 5 avocados a week for 12 weeks. 2. To ascertain the choline, lutein, and fatty acids present in human milk in women who eat avocado. 3. To measure the cognitive advantage conferred to infants whose mothers consume avocados while breastfeeding compared to a non-avocado-eating reference group. To this end, healthy, lactating women who are 13 weeks postpartum and their infants will be enrolled. Mothers will be provided avocados on a bi-weekly basis and will be asked to consume an avocado a day. Infant cognition will be tested when the infants are 4.5 and 6 months of age. Milk samples and diet data will be collected and assayed on a bi-weekly basis.

Начало: 08.02.2024 Край: 31.12.2028 Възраст: 18–40 г.

United States University of North Carolina, Chapel Hill NCT06208085

Набира участници Фаза 3

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

Multiple Myeloma

The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: * Are 18 years of age or older and have MM. * Have received treatments before for MM. * Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as: * a shot under the skin at the study clinic * through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.

Начало: 08.02.2024 Край: 30.12.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +24 Pfizer NCT06152575

Набира участници

Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study

Cognitive Decline Cognitive Impairment

The proposed research is a randomized crossover trial designed to assess changes in postprandial cognitive function and the gut-brain axis in adults with subjective cognitive complaints who consume 1 study snack per day for 1 week.

Начало: 07.02.2024 Край: 31.12.2026 Възраст: 40–75 г.

United States Ohio State University NCT06223672

Набира участници Фаза 2

Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

Locally Advanced Rectal Cancer

phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.

Начало: 05.02.2024 Край: 01.09.2028 Възраст: 18–75 г.

China Jinhua Central Hospital NCT06204094

Набира участници Фаза 2/3

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

Muscle Invasive Bladder Urothelial Carcinoma Muscle Invasive Renal Pelvis Urothelial Carcinoma Muscle Invasive Ureter Urothelial Carcinoma Muscle Invasive Urethral Urothelial Carcinoma +3

This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.

Начало: 02.02.2024 Край: 02.09.2030 Възраст: от 18 г.

Canada, United States National Cancer Institute (NCI) NCT05987241

Набира участници

INfectious DIsease REgistry BIObank

Bloodstream Infections Central Nervous System Infections Bone and Joint Infections Endovascular Infections +3

Prospective observational study designed to describe the clinical, laboratory, imaging, microbiological characteristics and treatment of specific infectious diseases, with the addition of a dedicated biobank.

Начало: 01.02.2024 Край: 31.07.2044 Възраст: от 18 г.

Italy IRCCS San Raffaele NCT06418048

Набира участници Фаза 2/3

Neoadjuvant Serplulimab & Bevacizumab With FOLFOX vs. FOLFOX Alone in RAS/BRAF WT, pMMR/MSS CRC Patients

Colorectal Cancer Liver Metastases

The primary objective of this study is to assess whether the addition of Serplulimab (a PD-1 inhibitor) and Bevacizumab (an anti-angiogenesis agent) to the standard FOLFOX chemotherapy can enhance the immune microenvironment in the liver, increase T lymphocyte infiltration, and consequently improve the postoperative prognosis for patients with surgically resectable colorectal cancer liver metastases (RAS/BRAF wild-type, pMMR/MSS) compared to FOLFOX alone.

Начало: 01.02.2024 Край: 31.12.2029 Възраст: 18–75 г.

China Sun Yat-sen University NCT06280495

Набира участници

PEP-buddy in COPD: Effect on Dyspnea Severity and Mechanism of Action

COPD

Chronic dyspnea is the most characteristic symptom of patients with Chronic Obstructive Pulmonary Disease (COPD), with intermittent increases during exercise and other events.Despite optimal standard therapy, episodic dyspnea is a common occurrence in COPD. Recently, the PEP buddy was developed which is an easy-to use, hands-free device that generates positive expiratory pressure (PEP). Although currently the available evidence is limited, it indicates that utilizing the PEP-buddy can result in enhancements in dyspnea during exertion, exertional desaturation and overall quality of life. More research is needed to evaluate the effectiveness of this device and the long term usability, as well as getting more insight in the mechanism of action. Therefore, the aim of our study is to explore the potential of this device for patients with COPD and episodic breathlessness.

Начало: 31.01.2024 Край: 31.12.2026 Възраст: от 40 г.

Netherlands University Medical Center Groningen NCT05938738

Набира участници

Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity

Morbidity;Perinatal

The goal of this randomized controlled intervention trial is to evaluate an integrated, interdisciplinary, multi-level maternity care home model (MCHM) aimed at reducing severe maternal morbidity (SMM) among a group of Black indigenous and people of color (BIPOC) patients. The main question it aims to answer is whether a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for the most vulnerable patients, thereby reducing SMM. Participants will be randomized to a MCHM (office-based prenatal care that is integrated with social services within the MCHM) or standard of care (office-based prenatal care with individually outsourced social services referrals) and followed during pregnancy through 1 year postpartum.

Начало: 30.01.2024 Край: 31.01.2028 Възраст: 16–55 г.

United States University of Pennsylvania NCT06245057

Набира участници Фаза 3

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM

Glioblastoma Recurrent Glioblastoma GBM

The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.

Начало: 29.01.2024 Край: 30.06.2028 Възраст: от 18 г.

Austria, Belgium, Denmark +7 CarThera NCT05902169

Набира участници Фаза 2

Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease

Chronic Graft Versus Host Disease

This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.

Начало: 29.01.2024 Край: 31.12.2027 Възраст: от 18 г.

United States Northside Hospital, Inc. NCT06046248

Набира участници Фаза 1/2

Feasibility of Semaglutide in Advanced Lung Disease

Obesity Interstitial Lung Disease Chronic Obstructive Pulmonary Disease Sarcoidosis, Pulmonary +1

The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease. The main question\[s\] it aims to answer are: 1. Are patients with advanced lung disease able to tolerate semaglutide therapy? 2. Are we able to titrate semaglutide therapy to a target weight? Participants will be asked to perform pulmonary function, physical function and body composition testing, as well as a blood draw before and after 12-weeks of semaglutide therapy. While on therapy, subjects will be surveyed regarding any adverse events or side effects.

Начало: 29.01.2024 Край: 28.12.2027 Възраст: 18–80 г.

United States University of Pennsylvania NCT05746039

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