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Showing 1-20 of 2,096 trials
NCT03277638
The purpose of this study is to test the side effects and efficacy of using Laser Interstitial Thermotherapy (LITT) combined with Pembrolizumab. LITT is a minimally invasive surgical technique that uses a laser to heat brain tumors. Pembrolizumab is an investigational (experimental) drug that works by helping participants' immune system work correctly to detect and fight cancer cells. Pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA), for this use, though it is approved to treat other cancers.
NCT07348783
Brief Summary: Migraine and/or Cluster Headache: Study Overview \*\*Background:\*\* Migraine and cluster headache are two primary headache disorders that significantly impact quality of life and functionality in those affected. According to the WHO's recurring burden of disease reports, migraine is among the neurological conditions responsible for the highest number of years lost due to illness. The headaches associated with migraine and cluster headache range from moderate to severe and cause great suffering. Available treatments do not work for everyone and are often associated with adverse side effects. Physical activity has been shown in several studies to have a positive effect on headache. Given the high prevalence of mental health issues, stress, and sleep problems within this patient group, relaxation and low-intensity exercise such as yoga-based movements (YB) could potentially help individuals improve sleep and well-being, while also providing some preventive effect on headaches. \*\*Hypothesis:\*\* Individuals with severe migraine or cluster headache have a strong need for new treatment options. Alternative therapies such as yoga-based exercises, when combined with standard medical treatment as per clinical guidelines, may positively impact: Headache symptoms, Sleep quality and Overall life quality * Purpose and Goals:\*\* This randomized controlled study aims to evaluate the effect of a web-based yoga (YB) or live face to face (FTF) intervention in individuals suffering of primary headaches-mainly chronic migraine and/or cluster headache. The study will assess the effect of YB on health-related changes in headache frequency, intensity, and duration associated with primary headache conditions, with a focus headache frequency. A secondary objective is to analyze quality of life, sleep quality, mental health as depression and anxiety. The RCT will also measure objective sleep and biomarkers. We are now summarizing the effects after a pilot study. * Relevance for the Patient Group:\*\* The core objective of the project is to determine whether yoga-based exercises can serve as a complementary treatment to enhance quality of life and health in patients with severe primary headache. To ensure equal healthcare access, this intervention will be delivered in digital format and/or FTF to optimize availability and expand care for individuals with primary headache disorders. These efforts aim to improve life quality and well-being in a vulnerable patient population. Headache conditions often affect individuals in their most productive years, and many live with symptoms for decades. Both work and private life are frequently disrupted, resulting in sick leave and social isolation. Close relatives are also affected, as those suffering from headaches require more recovery time to cope with daily life. With this proposed project, we aim to use physical yoga, rooted in holistic traditional medicine, to help individuals with severe primary headache achieve better physical and mental health-particularly improved sleep quality, which in turn enhances overall life quality.
NCT06631261
Individuals with bronchiectasis exhibit productive cough and recurrent lung infections as well as reduced exercise capacity, physical activity level, and respiratory and peripheral muscle strength. 6-minute walk test (6MWT) is often used to assess exercise capacity in chronic lung diseases. 6MWT is recommended to be performed along a flat corridor, at least 30 m long, with low pedestrian traffic, on a hard surface. To overcome technical limitations during 6MWT, 6-minute stepper test (6MST) has been proposed to assess exercise capacity. Another test that provides information about exercise capacity is the 1-minute sit-to-stand test (1STS). To our knowledge, there is limited information about different exercise tests including 6MST and 1STS and cardiopulmonary responses to these tests in individuals with bronchiectasis. Therefore, this study aims to compare the responses to the 6MST between individuals with bronchiectasis and healthy controls and to investigate the relationships among 6MST, 6MWT, and 1STS responses and muscle strength.
NCT02682667
Background: Cancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments. Objective: To better understand the biology of malignancies and why certain cancers respond differently to treatment. Eligibility: Adults at least 18 years old with cancer or a pre-cancerous condition. Design: Participants will be screened with a medical history, physical exam, and blood tests. Their diagnosis will be confirmed by the NCI Laboratory of Pathology. Participants will send tissue blocks or slides from their original tumor biopsy. At least once, participants will have a medical history, physical exam, and blood and urine tests. Participants may have the following tests. They may have them more than once: Apheresis. A needle in one arm removes blood. Blood is run through a machine and the sample cells are taken out. The rest of the blood is returned by a needle in the other arm. Bone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle. Piece of cancer tissue taken by a needle and syringe. Computed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a machine that takes pictures. A small piece of skin removed. Participants will be contacted by phone once a year to find out how they are doing.
NCT07300436
This is Single-center, randomized, open-label, single-dose, two-period crossover study design. The goal is to preliminary evaluate the PK comparability of TJ101 injection before and after CMC change following a single subcutaneous injection of 1.2 mg/kg in healthy male subjects in China, and to assess whether the two formulations are bio equivalent.
NCT07235267
This cross-sectional, comparative study aims to examine the intra-rater reliability, validity, and feasibility of tele-assessment versions of three functional mobility tests-the Timed Up and Go (TUG), 30-second Sit-to-Stand (30sSTS), and Gait Speed Test (GST)-in community-dwelling older adults (≥65 years). To provide a comparative perspective, the same assessments will also be administered to a younger, healthy control group (18-44 years). The study seeks to determine whether tele-assessment can serve as a robust and practical alternative to in-person testing, thereby enhancing accessibility and ensuring high-quality functional evaluation in geriatric populations.
NCT01676805
Background: \- Lab studies help researchers better understand cancer biology. This information may lead to new methods for diagnosing or treating cancer. To develop these studies, researchers want to collect samples from people with cancer or precancer conditions of the lymph system. These conditions include multiple myeloma, different types of lymphoma, and adult leukemia/lymphoma. The samples collected will include blood, urine, bone marrow, and tumor and skin tissue. Objectives: \- To collect tissue samples to study different types of lymph cancer. Eligibility: \- Individuals at least 18 years of age who have a lymphoid cancer or precancer condition. Design: * Participants will be screened with a physical exam and medical history. * Different samples will be collected for study. Blood samples will be collected at the initial testing. More blood samples will be collected at different treatment points. Other liquid samples include urine, bone marrow, and any abnormal fluid. Tumor tissue and skin tissue biopsies will also be collected for study. * Treatment will not be provided as part of this study.
NCT07606573
Early feasibility study to establish quantitative physiological markers correlated with noninvasive stimulation.
NCT07632456
This single-center randomized controlled trial aims to investigate the efficacy of transcutaneous auricular vagus nerve stimulation in alleviating nausea in healthy adults. The primary aim of this study is to assess the efficacy of taVNS in reducing nausea in healthy adults subjected to nausea induction through intragastric lipid infusion, compared to sham stimulation, as measured by 0-100 Visual Analogue Scale (VAS) scores. The secondary objectives include evaluating the potential of taVNS to alleviate other gastrointestinal symptoms, such as abdominal pain, bloating, and fullness, as well as exploring its effects on the desire to eat, all measured using 0-100 VAS scores. Additionally, changes in autonomic parameters, plasma levels of ghrelin and motilin, and salivary cortisol will be evaluated. The relationship between the nausea response and affective symptoms, as well as personality traits, will also be explored. Participants will be randomly assigned to either the taVNS or the sham stimulation group, with the intervention administered for 30 minutes immediately following nausea induction through intragastric lipid infusion.
NCT07631975
There is a need for studies that examine the role of dual-task cost in predicting fall risk among older adults receiving institutional care and that develop classification models that can be used in clinical practice. The planned study aims to determine the discriminative ability of dual-task cost in identifying fall risk and to establish clinically meaningful cutoff values. In this respect, the study will both contribute to a more sensitive assessment of fall risk and provide a scientific basis for a low-cost, practical, and applicable screening approach.
NCT04844775
EHVA P01 is an international, phase I, prophylactic HIV vaccine trial to evaluate the safety and immunogenicity of HIV Clade C DREP alone and in Combination with a Clade C ENV protein in healthy HIV-uninfected adults.
NCT07628842
This single-center randomized controlled trial aims to investigate the effects of transcutaneous auricular vagus nerve stimulation on the acute stress responses. The primary aim of this study is to assess the efficacy of taVNS in mitigating the acute stress response induced by the Maastricht Acute Stress Task (MAST) among healthy subjects, measured by cortisol levels in saliva samples. Secondary objectives include: * Evaluating taVNS's potential to counteract stress-induced sympathetic activation and thereby alleviate stress-related effects, including negative affect, as measuring using the I-PANAS-SF questionnaire, and feelings of stress, pain, and unpleasantness, as measured with 0-100 Visual Analog Scales (VAS) * Assessing its impact on autonomic outflow parameters, using a blood pressure monitor for blood pressure, and a FitBit smartwatch for heart rate variability, and Shimmer3 GSR sensor for heart rate variability and skin conductance. * Evaluating the relationship between stress responses and affective symptoms and personality traits, utilizing the Generalized Anxiety Disorder 7-Item Scale (GAD-7), Patient Health Questionnaire (PHQ-9), and the Big Five Inventory (BFI). Participants will be randomly assigned to either the taVNS or sham stimulation group, administered 30 minutes before the MAST.
NCT07376044
The goal of this clinical trial is to assess nutrition incentives and produce vouchers to measure the impacts of food insecurity-related chronic health conditions in adults with hypertension and/or diabetes. The main questions it aims to answer are: * Does participation increase fruit and vegetable consumption for participants? * Does participation reduce individual and household food insecurity? * Does participation reduce healthcare utilization and associated costs? * Does participation lead to improvements in diet-related health outcomes (e.g., hypertension, diabetes)? * Does participation support the local economy by increasing participant spending at local food vendors? Participants will: * Receive 6 months home delivered produce prescription boxes * Receive 6 months match of produce vouchers * Receive nutrition education and participate in Chronic Disease Self-Management classes
NCT05768139
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant, tamoxifen, or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib) in participants with HR+ breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.
NCT07610343
Patients with cognitive decline are frequently comorbid with sleep disorders which may in turn aggravate cognitive decline. Sedative dose dexmedetomidine improved sleep quality but incresed bradycardia and hypotension; low dose dexmedetomidine produce less side effects, but the sleep promoting effects are relatively weak. Low dose esketamine also has sleep-promoting effects but may produce neuropsychiatric side effects. Both dexmedetomidine and esketamine are approved for intranasal administration. We suppose that intranasal administration of dexmedetomidine-esketamine combination may improve sleep quality and therefore cognitive function in older ptients with Alzheimer's disease cognitive impairment and sleep disorders.
NCT05271240
Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. The investigators have completed a Phase I clinical trial that has shown that Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (BV) is safe up to a dose of 15mg/kg in patients with recurrent malignant glioma. Additionally, the investigators have shown in a recently completed Phase I/II clinical trial, that SIACI BV improves the median progression free survival (PFS) from 4-6 months to 11.5 months and overall survival (OS) from 12-15 months to 23 months in patients with newly diagnosed GBM. Therefore, this two-arm, randomized trial (2:1) is a follow up study to these trials and will ask simple questions: Will this repeated SIACI treatment regimen increase progression free survival (PFS-primary endpoint) and overall survival (OS-secondary endpoint) when compared with standard of care in patients with newly diagnosed GBM? Exploratory endpoints will include adverse events and safety analysis as well as quality of life (QOL) assessments. The investigators expect that this project will provide important information regarding the utility of repeated SIACI BV therapy for newly diagnosed GBM and may alter the way these drugs are delivered to our patients in the near future.
NCT05954858
This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients. The objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).
NCT07616050
The purpose of this clinical study is to evaluate the feasibility, usability, and motivational impact of VirtualPark, a virtual reality-based dual-task rehabilitation system, in adults with neurological and age-related conditions. VirtualPark is a virtual reality application designed to deliver cognitive exercises during cycling training using a commercially available ergometer (THERA-Trainer Tigo). The system integrates physical and cognitive tasks in simulated real-life environments. The intervention integrates motor and cognitive training tasks targeting domains such as attention, inhibition, working memory, and navigation. This is a prospective, multicenter, randomized, cross-over pilot study. It will compare cycling training performed with and without virtual reality. Participants will complete both intervention conditions over a 4-week period separated by a wash-out phase with standard rehabilitation activities. The order of conditions will be randomized. The study will assess motivation during rehabilitation training, usability and user experience of the system, as well as exploratory effects on cognitive and motor performance, functional abilities, perceived exertion, and safety. The study will enroll adult participants (≥18 years) with conditions such as stroke, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, mild cognitive impairment, spinal cord injury, and frail older adults.
NCT02583893
This pilot phase II trial studies whether biomarkers (biological molecules) in bone marrow samples can predict treatment response to sirolimus and chemotherapy (mitoxantrone hydrochloride, etoposide, and cytarabine \[MEC\]) in patients with acute myeloid leukemia (AML) that is likely to come back or spread (high-risk). Sirolimus inhibits or blocks the pathway that causes cancer cells to grow. Adding sirolimus to standard chemotherapy may help improve patient response. Studying samples of bone marrow from patients treated with sirolimus in the laboratory may help doctors learn whether sirolimus reverses or turns off that pathway and whether changes in biomarker levels can predict how well patients will respond to treatment.
NCT07571824
The purpose of this research study is to compare the bioavailability and adhesion of a generic Selegiline transdermal system (TDS) against the marketed comparator (EMSAM®) in healthy volunteers. Systemic and local safety and tolerability will be also observed and evaluated.