2,342 Clinical Trials for Various Conditions
The goal of this clinical trial is to characterize blood vessel function and oxidative stress (a harmful condition that damages cells and tissues) in emergency medical technicians (EMTs). The main questions it aims to answer are: 1. Does an overnight shift work in emergency medical technicians reduce blood vessel function and increase oxidative stress? 2. Can supplementing with antioxidants help reduce the negative effects of night shift work in emergency medical technicians? Researchers will compare antioxidants to a placebo (a look-alike substance that contains no drug) to see if antioxidants work in reducing the negative effects of night shift work in emergency medical technicians. Participants will: 1. Report to the lab two separate times following an overnight shift to assess blood vessel functioning and oxidative stress 3. Take an antioxidant supplement or placebo during each night of shift work.
Cardiovascular Function in EMTs
The purpose of this clinical investigation, the AMEND TS Early Feasibility Study is to evaluate the safety and functionality of the AMEND Trans-Septal System for annuloplasty as treatment of mitral regurgitation. Protocol Design Rationale The investigational device under this protocol consists of a "D"-shaped semi-rigid ring that is implanted using a transseptal approach. The ability to deploy the annuloplasty ring in a percutaneous fashion affords an improved safety profile for surgical candidates, as well as surgical style solution for those patients that are at elevated risk for surgery due to comorbidities and advanced age. This early feasibility study allows treatment of higher risk surgical candidates with a surgical- level annuloplasty repair therapy by the AMEND™ Implant. This clinical investigation is intended to evaluate the safety and functionality of the AMEND™ Trans-Septal System. Study results are expected to provide information that cannot be obtained through non-clinical testing, due to the limitations of in-vivo and in-vitro test models. The AMEND™ Trans-septal System has previously undergone extensive preclinical and bench testing as well as initial OUS clinical experience. The results of these tests and clinical data obtained so far, justify the use of the device in the EFS IDE study as proposed in this study protocol. DEVICE DESCRIPTION Valcare Medical AMENDTM Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments. The device is delivered through a catheter using a trans-septal approach and implanted in the beating heart on the atrial surface of the mitral valve annulus similar to surgical annuloplasty rings. The AMENDTM Trans-Septal System consists of a semi-rigid annuloplasty ring (implant), a delivery system (catheter), and accessories (Stage, Introducer sheath). The implant delivered under fluoroscopic and echocardiographic guidance, is placed and fixed to achieve an anatomic outcome that is consistent with standard open surgical annuloplasty procedures. The system is a single-use device, supplied sterile, non-pyrogenic and ready-for-use. Indications for Use The Valcare Medical AMEND™ Trans-Septal System is intended for correction of mitral insufficiency in adult male and female patients. It is indicated to treat patients with mitral regurgitation using a percutaneous direct annuloplasty approach. The decision to use an annuloplasty ring is made by the heart center team after reviewing the risks and benefits of alternative procedures and evaluating the patient's mitral valve disease.
Mitral Regurgitation Functional, Mitral Incompetence, Annuloplasty
The WeDecide study is a large observational study comparing the long-term effects of matched related donor hematopoietic stem cell transplantation (MRD HCT) and non-transplant disease-modifying therapies (NT-DMT) for pediatric patients with sickle cell disease (SCD). The study aims to assess health-related quality of life (HRQoL), cognitive function, risks, and benefits of both treatments, including survival rates, chronic complications, and organ damage prevention. With 160 children in the MRD HCT group and 320 in the NT-DMT group, aged 3-20.9 years, the study will follow participants for three years, examining factors like disease severity, treatment history, and social determinants of health. By providing a comprehensive comparison, the study seeks to inform clinical decisions and improve understanding of SCD treatment outcomes, ultimately supporting families and healthcare providers in choosing the best treatment options.
Sickle Cell Disease (SCD)
This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.
Asthma
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.
Breast Neoplasms
The study looks to investigate the effects that light therapy delivered to the frontal cortex could have on Parkinson's disease related symptoms ( both cognitive and motor). The therapy is a non invasive technique that deliverers low level wavelength light to the front part of the head for 12 minutes. for this study the therapy will be done 3 times a week for 6 weeks. To measure the potential effects on the therapy in Parkinson symptoms, we will do a set of cognitive and motor test before and after the intervention to measure any changes as well as control for any potential markers such as age, sex, disease level, medication and exercise.
Parkinson Disease
Below-the-Knee Interventions for Limb Salvage: Use of Multifunctional Angioplasty Balloon Catheters ("BTK Multicath Registry") A non-randomized clinical registry This study is designed to obtain preliminary data on clinically relevant procedural variables during percutaneous below-knee artery revascularization procedures among consecutive patients treated with either the Finesse BTK Multicath® ("Finesse") or the standard of care using conventional angioplasty balloon catheters. This registry will enroll participants with a history of chronic limb threatening ischemia and below-knee arterial insufficiency who will be assigned to revascularization with or without use of the Finesse BTK Multicath. The registry is an acute study examining procedural data only. The primary endpoints of interest are the volume of contrast used for the intervention, overall procedure time, radiation dose, number of catheter exchanges during revascularization, and medical device supply costs. For the first phase 12 consecutive patients will be treated with the standard of care. For the second phase 12 consecutive patients will be treated with Finesse. 24 participants total Up to 5 study sites in the United States Initial anticipated enrollment: Q4 2024 Last anticipated enrollment: Q2 2025 Patients \>=18 years old with documented history of unilateral chronic limb threatening ischemia due to below-knee arterial insufficiency with angiographic runoff in the foot and limited arterial insufficiency above the knee 1. Contrast volume administered during the revascularization portion of a procedure. 2. Number of catheter exchanges during revascularization 3. Fluoroscopy time 4. Radiation dose during revascularization 5. Procedure time post-enrollment 6. Equipment costs 7. Reduced use of supplies 8. Technical success 9. Safety/Major Adverse Peripheral Events On-treatment sample Intention-to-treat
Peripheral Arterial Disease Below the Knee, Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization
This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.
Asthma
Autologous Adipose Cell Therapy is a series of process designated to address the demerits of the traditional autologous fat grafting and dermal fillers, while enhancing the versatility and aesthetic outcomes. In this study, the goal is to evaluate the safety and efficacy of Autologous Adipose cell Therapy for skin rejuvenation and hair improvement in human application.
Hair Loss/Baldness, Wrinkle Appearance, Volume, Fine Lines, Skin Elasticity, Hair Thinning, Skin Pigmentation, Skin Texture
The objective of this proposal is to determine whether heightened negative affective responsivity (NA-R) to daily stressors is related to blunted nitric oxide (NO)-mediated endothelium-dependent dilation (EDD) in working age adults and the extent to which this association is impacted by major depressive disorder (MDD).
Major Depressive Disorder
Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration. The investigators aim to determine if sub-dissociative ketamine is non-inferior to morphine for treating acute pain and a preferable alternative for treating acute pain in children because of its more favorable side effect profile and potential long-term benefits related to pain-related function, analgesic use/misuse, and mental and behavioral health outcomes.
Abdominal Pain, Isolated Extremity Fracture, Pain, Pediatrics
The present study explored the use of a technique called stochastic resonance (SR) stimulation that may help individuals with Parkinson Disease maintain balance while walking on challenging surfaces. Impaired balance represents one of the disease symptoms, putting people at risk for falls, partly due to impaired processing of sensory information. SR uses light electrical signals to improve the way the body detects sensations. We wanted to test if SR could help people with Parkinson disease stay steadier while walking. Each participant's optimal SR intensity was determined before they walked on a treadmill in a virtual environment that created visual disturbances to challenge their balance. We measured how much their body swayed, how they placed their feet, and how their ankles moved during the walking tasks.
Parkinson Disease
The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS). It will also teach us about the safety of ARD-101. The main questions it aims to answer are: * Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)? * What medical problems do participants have when taking ARD-101? Researchers will compare ARD-101 to a placebo (a look-alike substance that contains no drug) to see if ARD-101 works to treat hyperphagia in PWS subjects. Eligible participants will: * Take ARD-101 or a placebo every day for 12 weeks. * Visit the clinic or have a tele-visit once every 2 to 4 weeks during dosing and then have a tele-visit 4 weeks after stopping the ARD-101 or placebo. * Patients/Caregivers will keep a daily diary.
Hyperphagia, Prader-Willi Syndrome
There is no consensus regarding the neurological substrate underpinning ASD. The investigators describe the novel concept of "social reciprocity network" and hypothesize that aberrant connectivity/oscillatory patterns affecting this network contribute to the core deficits in ASD. The overarching goal of this trial is to explore abnormalities involving the neuronal connectivity and oscillatory patterns within the social reciprocity network and to elucidate the role of modulating this network via rTMS in improving the above measures and social cognition in ASD. Quantitative electroencephalography (QEEG) coherence and spectral power analysis are reliable measures of neuronal connectivity and dynamics. The investigators aim to study the QEEG coherence/spectral power analysis to explore the neuronal dynamics affecting the social reciprocity network in ASD.
Autism Spectrum Disorder
This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.
HIV Infections
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
Non-small Cell Lung Cancer
This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to treat postmenopausal women with hormone-dependent breast cancer. Giving low dose tamoxifen may be more effective compared to usual hormone therapy in treating post-menopausal women with hormone-positive, HER2 negative early stage breast cancer.
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma
The purpose of this basket study in children with Turner syndrome, SHOX deficiency, and Noonan syndrome is to evaluate the effect of 3 doses of vosoritide versus hGH on growth as measured by AGV after 6 months of treatment. The long-term efficacy and safety of vosoritide at the therapeutic dose will be evaluated up to FAH.
Short Stature Homeobox- Containing Gene SHOX Deficiency, Noonan Syndrome, Turner Syndrome
This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma (RCC), Stage II Renal Pelvis Cancer AJCC v8, Stage III Renal Pelvis Cancer AJCC v8
This clinical trial tests different programs to help patients with acute lymphoblastic leukemia (ALL) remember to take their medications during maintenance therapy at home. One problem with ALL maintenance treatment is remembering to take medicines at home like patients are supposed to. In maintenance, a medicine called 6-mercaptopurine or "6MP" is taken by mouth every day at home. In this study, 6MP prescriptions are filled into a special medication bottle called MEMS® which is fitted with a special cap called TrackCap™ that electronically records when the medication bottle is opened. Researchers are trying a new program to help patients be better at taking their 6MP like they're supposed to. This new program may help patients to remember to take their 6MP medication.
Acute Lymphoblastic Leukemia, Childhood Acute Lymphoblastic Leukemia
This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing
Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.
Resectable Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8
The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.
Non-squamous Non-small Cell Lung Cancer
Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents.
Hypertension, Food Insecurity
This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.
Sickle Cell Disease
This research study is designed to assess the prevalence of specific antibodies and inflammatory cytokines in adult and pediatric participants with CGD.
Chronic Granulomatous Disease (CGD)
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.
Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, FIGO Stage III Ovarian Cancer 2014, FIGO Stage IV Ovarian Cancer 2014, Ovarian Carcinoma, Ovarian High Grade Endometrioid Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal Endometrioid Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma
The clinical study aims to develop and test a gamified mobile health app called PuzzleWalk (PW) to promote physical activity (PA) and reduce sedentary behavior (SB) in autistic adults, including those with mild intellectual disabilities (ID). The study addresses the need for tailored interventions in this population, who are at higher risk for lifestyle-related chronic health conditions due to lower PA and higher SB. The upgraded version of PuzzleWalk integrates behavior change techniques and gamification strategies, such as translating step counts into puzzle game playtime, to encourage regular PA and reduce SB. The study will evaluate the app's effectiveness on preventive health behavior changes in real-world settings. The ultimate goal is to create an effective, sustainable, and scientifically validated mobile health tool to improve the health and well-being of autistic adults.
Autism Spectrum Disorder
This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.
Non-small Cell Lung Cancer
High blood pressure (hypertension) is a known side effect of the treatment with fruquintinib. Current research does not provide a clear answer whether minority groups such as Black/African American and/or Hispanic/Latino with refractory metastatic colorectal cancer (mCRC) have a bigger risk of higher blood pressure after treatment with fruquintinib. The main aim of this study is to learn how often adults of a minority group experience hypertension after they have been treated with fruquintinib for refractory mCRC. Other aims are to learn how safe fruquintinib is and how well it is tolerated by participants. Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens, they do no longer tolerate the treatment or stop the treatment for other reasons. After the last treatment, participants will be checked upon every 3 months until study completion.
Colorectal Cancer