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Balance After Traumatic Brain Injury

Traumatic Brain Injury

A moderate traumatic brain injury (TBI) occurring in early or middle adulthood might have long-lasting effects on the brain that can accelerate the decline of physical and cognitive function in older age. The proposed study seeks to better understand the implications of aging with a TBI, in order to help Veterans maintain their health and independence. The overarching hypothesis of this new line of research is that participants who experienced a moderate TBI in early or middle adulthood (at least 15 years prior to study enrollment) will have poorer performance on balance and cognitive tests, despite self-reporting no persistent motor or cognitive impairment from the TBI. The investigators also seek to evaluate the potential for practice-based learning and improvement of complex balance tasks in this population, to gain experience for conducting future rehabilitation studies. The long term goal of this line of research is to design rehabilitative and lifestyle interventions to preserve brain health and function in Veterans who have previously experienced a TBI.

Начало: 21.03.2024 Край: 30.06.2026 Възраст: 50–75 г.

United States VA Office of Research and Development NCT05714150

Набира участници Фаза 1

A Phase 1 of CTX-8371 in Patients With Advanced Malignancies

Non Small Cell Lung Cancer Triple Negative Breast Cancer Hodgkin Lymphoma Head and Neck Squamous Cell Carcinoma +1

This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 cohorts: Dose Escalation and Dose Expansion.

Начало: 19.03.2024 Край: 01.05.2027 Възраст: от 18 г.

United States Compass Therapeutics NCT06150664

Набира участници Фаза 4

Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease

Alzheimer Disease Insomnia Disorder Sleep

DARIDOR-ALZ is a phase IV clinical trial designed to evaluate both the efficacy and safety of daridorexant, a selective dual orexin receptor antagonist that blocks the actions of the orexin neuropeptides at both orexin-1 and orexin-2 receptors, in selected populations of MCI and mild-to-moderate AD patients with insomnia complaints.

Начало: 13.03.2024 Край: 13.03.2028 Възраст: 60–85 г.

France University Hospital, Montpellier NCT05924425

Набира участници Фаза 1

A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors

Breast Cancer Small Cell Lung Cancer Ovarian Cancer Gastric Cancer +8

This study is a first-in-human (FIH), Phase 1a/1b study of BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-68501 in participants with advanced, nonresectable, or metastatic solid tumors as monotherapy and in combination with fulvestrant with or without BGB-43395, a selective CDK4 inhibitor, in adults with hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC). The study will also identify a recommended dose for expansion (RDFE) for BG-68501 as monotherapy and in combination for subsequent disease directed studies. The study will be conducted in 2 parts: Part 1 (dose escalation and safety expansion, including evaluation of food effect) and Part 2 (dose expansion).

Начало: 11.03.2024 Край: 01.07.2028 Възраст: от 18 г. Лечение

Australia, China, Israel +3 BeiGene NCT06257264

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Fine Needle Aspiration (FNA) Evaluation of the Intrahepatic HBV Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients

Chronic Hepatitis b

Two hundred and ninety-six million people worldwide are chronically infected with the hepatitis B virus (HBV), with around 750,000 deaths each year linked to the development of cirrhosis or hepatocellular carcinoma. Current treatments based on nucleoside analogues (NA) achieve virological cure in only 5% of cases at 10 years. The virological persistence of HBV is explained by the persistence of cccDNA (covalently-closed circular DNA) in the nucleus of hepatocytes. Complex and poorly understood interactions between immunological and virological responses explain the persistence of ccccDNA. A better understanding of the immunological and virological interactions of the intrahepatic compartment during chronic HBV infection is needed to better understand the mechanisms of viral persistence and for research and development of new drugs to achieve the goal of a functional cure for HBV (defined as the prolonged loss of Hepatitis B surface antigen (HBsAg) after cessation of treatment, associated with a decrease in intrahepatic cccDNA or its transcriptional inactivation). The intra-hepatic compartment can be explored by liver biopsy. A fine needle aspiration (FNA) technique is used to characterize primary hepatic tumors, with fewer complications than liver biopsy. One study has validated its use for immunological exploration of the intra-hepatic compartment. Finally, a recently published study confirms a correlation between FNA and liver biopsy virological markers in patients with chronic HBV infection. However, no combined immuno-virological study has been carried out to explore this intra-hepatic compartment by FNA in patients with chronic HBV infection. The investigators will assess the intrahepatic compartment of patients chronically infected with HBV (+/- hepatitis Delta (HDV)) to understand the mechanisms of viral persistence and characterize host immune responses to HBV. These investigations will make it possible to determine the immuno-virological profiles of patients who would benefit from intensification of antiviral treatment or, potentially, discontinuation of antiviral therapy.

Начало: 08.03.2024 Край: 08.03.2030 Възраст: от 18 г.

France Hospices Civils de Lyon NCT06047093

Набира участници Фаза 1

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown.

Начало: 06.03.2024 Край: 01.11.2026 Възраст: 18–70 г.

United States Sonoma Biotherapeutics, Inc. NCT06201416

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Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia

Smoking Cessation Smoking, Cigarette Smoking Reduction Smoking +2

The goal of this clinical trial is to evaluate the effectiveness and implementation of a pharmacist-delivered MTM (medication therapy management) approach, called QuitAid, to quitting cigarette smoking in rural Appalachia. The main questions it aims to answer are: * Is QuitAid, alone or combined with other quitting tobacco treatments, effective? * What makes QuitAid easy or hard to carry out? Is it cost effective? Is it easy to maintain? Treatment: All participants will be given at least 4 weeks of the nicotine patch. Some participants will be randomized (like the flip of a coin) to receive additional treatments (listed below). These groups will be compared to each other to see which combination works best to help them quit smoking. * Smokefree TXT - a texting program that helps people quit smoking * Tobacco quitline - 4 phone sessions to help people quit smoking * 8 weeks of NRT (nicotine replacement therapy in the form of nicotine patches or nicotine patches and lozenge) medication instead of 4 weeks * QuitAid - An MTM program given by the patient's pharmacist. This is a quitting smoking coaching program * Nicotine patch AND nicotine lozenge instead of just nicotine patches

Начало: 06.03.2024 Край: 01.03.2028 Възраст: от 18 г.

United States University of Virginia NCT05660525

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Spinal Cord Injury Model Systems (SCIMS) - Education Module

Spinal Cord Injuries Obesity Cardiometabolic Syndrome

The purpose of this study is to find out if receiving education regarding increased risks of cardiometabolic disease helps subjects understand these risks and how these risks participants' health.

Начало: 05.03.2024 Край: 31.10.2026 Възраст: 18–70 г.

United States University of Miami NCT06003686

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An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)

Retinopathy of Prematurity Preterm Infants

This is an observational study in which only data from babies with retinopathy of prematurity (ROP) who are being treated with aflibercept (Eylea) in prefilled syringe (PFS) using a paediatric dosing device (PDD) are collected and studied. ROP is a condition that affects the eyes of preterm babies. It occurs when the baby's retina, the part of the eye that senses light, does not develop normally. This may result in vision problems, including blindness, if left untreated. Preterm babies are born before 37 weeks of pregnancy. ROP is more likely to develop in babies who are born before 32 weeks of pregnancy or weigh less than 1.5 kilograms at birth. Aflibercept is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth of blood vessels in the retina. Aflibercept in PFS given using a PDD is approved for the treatment of babies with ROP. The prefilled syringe will be fitted with an injection needle to give aflibercept. And a PDD is a tool used to give the right amount of aflibercept to children in a safe manner. Since there are other treatments which are commonly used for babies with ROP, the extent of use of aflibercept given using a PDD is unknown. The main purpose of this study is to: * find the number of preterm babies who are treated with aflibercept using a PDD in the UK * inform whether this number is enough to perform a study to learn about the long-term safety of aflibercept given using a PDD in babies with ROP An additional purpose of this study is to describe characteristics including age, sex, and race, and signs and symptoms of ROP observed in babies being treated with aflibercept using a PDD. The data will come from a database called the National Neonatal Research Database. The study will cover the period from March 2024 to March 2025, if the number of babies found is enough to perform the safety study. If not, data will be collected till April 2027. In this study only available data from preterm babies born during the study period are collected. No visits or tests are required as part of this study.

Начало: 05.03.2024 Край: 30.04.2027 Възраст: до 1 г.

United Kingdom Bayer NCT06315556

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Assessing the Efficacy and Safety of ctDNA-driven Selection for Anti-EGFR Retreatment in a Real World Metastatic Colorectal Cancer Patients Cohort (the REalCHALLENGE Study)

Metastatic Colorectal Cancer (CRC)

This is an observational, retrospective, international and multicenter study funded by Fondazione Oncologia Niguarda ETS to assess the efficacy of anti-EGFR rechallenge regimens in the largest real-world cohort of MSS mCRC patients screened for RAS/BRAF/PIK3CA ctDNA status on liquid biopsy within the MEN1611-02 C-PRECISE-01 trial. The study will collect molecular, clinical and outcome data of patients already available at participating centers.

Начало: 01.03.2024 Край: 01.09.2026 Възраст: от 18 г.

Italy Niguarda Hospital NCT07536113

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Laser Treatment for Lichen Sclerosus

Lichen Sclerosus Lesion

Fractional ablative laser treatment for Lichen Sclerosus lesion

Начало: 01.03.2024 Край: 30.12.2027 Възраст: от 18 г.

Canada Sciton NCT06389071

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Motivations, Attitudes, and Perceptions Study

Alcohol Drinking Sexual Violence Social Norms

The goal of this clinical trial is to compare the impact of providing participants with 1. A recently developed protocol for motivating bystanders to intervene to help others who are in sexual risk situations (Motivate-the-Bystander) alone 2. Motivate-the-Bystander with an alcohol component focused on reducing drinking behaviors (Motivate-the-Bystander+Alcohol) 3. A control condition focused on reducing stress The main questions it aims to answer are: * Is Motivate-the-Bystander more effective than the attention control for increasing bystander behaviors? * Is Motivate-the-Bystander+Alcohol more effective than MTB alone for increasing bystander behaviors? * Is Motivate-the-Bystander+Alcohol more effective than Motivate-the-Bystander alone for decreasing alcohol use during bystander intervention opportunities? Participants will: * Complete online measures (e.g., self-reported bystander behaviors, past bystander training, history of bystander intervention attempts, sexual experiences, drinking behaviors, and other substance use behaviors) * Complete either MTB, MTB+ALC, or the attention control condition online * Complete the virtual reality simulation in the lab * Complete electronic daily diary follow-up surveys about alcohol use and bystander intervention

Начало: 01.03.2024 Край: 31.05.2026 Възраст: 18–25 г.

United States University of Nebraska Lincoln NCT05873413

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Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

Breast Cancer Cognitive Impairments

This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.

Начало: 29.02.2024 Край: 30.11.2027 Възраст: 18–100 г.

Puerto Rico, United States NRG Oncology NCT05896189

Набира участници

Comparison of Residual Gastric Volume Between Children Who Drink Different Clear Oral Fluid Volume

Fasting Gastric Emptying

According to the American Society of Anesthesiologists (ASA) fasting guideline for patients undergoing elective surgery, the 2-hour fasting period is suggested for clear oral fluid (including water, pulp-free juice and tea or coffee without milk). This guideline does not give any suggestions for proper volume of clear oral fluid intake. This study is a prospective randomized control trials in children aged 13 through 17 years who are scheduled for an elective upper GI endoscopy procedure in the Gastroenteral Procedure Unit (GPU) at Boston Children's Hospital. The participants will be randomly assigned into one of four groups: Group 1 will consume 3 ml/kg of clear fluid by mouth at 2-hour period before surgical scheduled time, Group 2 will consume 5 ml/kg, Group 3 will consume 7 ml/kg, and Group 4 will consume 10 ml/kg. The investigators plan to recruit 72 patients in each group and 288 patients for the whole study. Research team will collect patient's demographic data, vital signs, information about their EGD procedure. Then actual volume of the stomach content and acidity will be measured from the content that is suctioned from patient's stomach during upper GI endoscopy procedure. The investigators believe that the information from this study will help establish a comprehensive NPO guideline.

Начало: 29.02.2024 Край: 01.12.2027 Възраст: 13–17 г.

United States Boston Children's Hospital NCT03741777

Набира участници Фаза 3

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Early Breast Cancer

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

Начало: 28.02.2024 Край: 20.09.2030 Възраст: 18–100 г. Лечение

Argentina, Australia, Brazil +13 Novartis Pharmaceuticals NCT05827081

Набира участници

PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients

Coronary Artery Disease

Post-market, prospective, observational, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon (DCB)therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A percutaneous coronary intervention (PCI) with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician.

Начало: 26.02.2024 Край: 30.12.2026 Възраст: от 18 г.

Italy, Portugal, Spain Fundación EPIC NCT06321757

Набира участници

Association Between LRG and Histologic Remission in Ulcerative Colitis

Ulcerative Colitis in Histologic Remission

We attempt to clarify the serum leucine-rich α 2-glycoprotein (LRG) level which can predict histologic remission in ulcerative colitis patients in this study. Colonoscopy with histology will be performed when histologic remission is predicted, irrespective of symptoms or serum LRG values. Serum LRG levels are analyzed by an enzyme-linked immunosorbent assay.

Начало: 25.02.2024 Край: 31.12.2027 Възраст: 20–90 г.

Japan Showa Inan General Hospital NCT06372613

Набира участници Фаза 2

Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)

Obsessive-Compulsive Disorder

The purpose of this study is to understand how ketamine works in the brain to bring about a reduction in OCD symptoms.

Начало: 24.02.2024 Край: 01.11.2028 Възраст: 18–65 г.

United States Stanford University NCT05940324

Набира участници Фаза 1

A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

Multiple Myeloma

The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide. There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma. Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement. All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle. Participants will receive study medicine until: * their disease progresses or, * they experience unacceptable side effects or, * they choose to no longer take part in the study. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.

Начало: 20.02.2024 Край: 09.03.2028 Възраст: от 18 г. Лечение

Australia, Canada, United States Pfizer NCT06215118

Набира участници Фаза 1/2

JAK1/2 Inhibitor Ruxolitinib for Relapsed/Refractory Immune Bone Marrow Failure

Severe Aplastic Anemia Single Lineage Cytopenias, T-LGL Hypoplastic MDS

Background: Immune bone marrow failure is a condition that occurs when a person s immune system attacks the cells of the bone marrow. This can lead to diseases including different types of anemias and blood cancers. Some of these diseases can be deadly. Better treatments are needed. Objective: To test a drug (ruxolitinib) in people with different types of immune bone marrow failure. Eligibility: Adults aged 18 and older with an immune bone marrow failure. Design: Participants will be screened. They will have a physical exam. They will give samples of blood and saliva. They will have a bone marrow biopsy: A large needle will be inserted into a small cut to remove a sample of the soft tissue inside the bone. Some participants may have a skin biopsy: A small piece of skin will be removed. Some may have a computed tomography (CT) scan: They will lie on a table that slides into a donut-shaped machine that uses X-rays to make pictures of the inside of the body. Ruxolitinib is a tablet taken by mouth. Participants will take the drug twice a day for up to 6 months. Participants will have blood tests every week while they are taking the drug. These tests can be done by the participant s own physician and the results sent to the researchers. Participants will have clinic visits after taking the drug for 3 months and 6 months and then after 1, 2, and 3 years. The blood tests and bone marrow biopsy will be repeated. Participants who improve while taking the drugs may go on to an extension phase of the study.

Начало: 20.02.2024 Край: 03.06.2032 Възраст: 18–99 г.

United States National Heart, Lung, and Blood Institute (NHLBI) NCT05998408

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