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Clinical Trials in Nebraska

715 actively recruiting studies with sites in Nebraska. Filter by condition or check your eligibility in under a minute.

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Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor

Patients With Non-Small Cell Lung Cancer

Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance. Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).

Lincoln, NE18+ yrsAll genders
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A Clinical Trial to Evaluate Efficacy and Safety of Xeominยฎ Injections for Preventing Episodic Migraine

Episodic Migraine

In this clinical trial, participants with episodic migraine will receive injections with Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections. Trial details include: * Trial duration: 52 to 55 weeks; * Screening period: 4 to 5 weeks; * Treatment duration: 4 treatments, each about 12 weeks apart; and * Visit frequency: about every 4 weeks, 14 visits in total. The first and last visit and the 4 treatment visits are on-site, the other 8 visits are remote by phone / video call.

Omaha, NE18+ yrsAll genders
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A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

Non-Muscle Invasive Bladder Neoplasms

The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guรฉrin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

Omaha, NE18+ yrsAll genders
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A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

Ovarian Cancer ยท Fallopian Tube Cancer ยท Primary Peritoneal Cancer

The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.

Omaha, NE18+ yrsWomen
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An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

Schizophrenia

This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ยฑ 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \[BID\]) in subjects with schizophrenia.

Omaha, NE18โ€“65 yrsAll genders
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A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis

Recurrent Langerhans Cell Histiocytosis ยท Refractory Langerhans Cell Histiocytosis

This phase II trial tests the safety, side effects, best dose and activity of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that is growing, spreading, or getting worse (progressive), has come back (relapsed) after previous treatment, or does not respond to therapy (refractory). Langerhans cell histiocytosis is a type of disease that occurs when the body makes too many immature Langerhans cells (a type of white blood cell). When these cells build up, they can form tumors in certain tissues and organs including bones, skin, lungs and pituitary gland and can damage them. This tumor is more common in children and young adults. DAY101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Using DAY101 may be effective in treating patients with relapsed or refractory Langerhans cell histiocytosis.

Omaha, NE0โ€“22 yrsAll genders
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HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes

Type 2 Diabetes

Blood sugar levels are controlled by insulin, a hormone made by cells in the pancreas. After a meal, carbohydrates are broken down into glucose which is absorbed from the intestine into the blood leading to a rise in glucose (blood sugar) which triggers the secretion of insulin. Insulin binds to cells in several tissues including liver, muscle, and fat, triggering cells to take up glucose and bring the blood glucose level back to normal. A high blood sugar level is known as diabetes. The most common form of diabetes, type 2 diabetes, is caused by insulin resistance; that is, a reduced ability of insulin to stimulate glucose uptake into cells. The body compensates for insulin resistance by making more insulin; type 2 diabetes occurs when the pancreas can no longer make enough insulin to control blood glucose. The high blood glucose and insulin levels lead to long-term complications such as heart attacks, kidney failure, reduced sensation and poor circulation in the feet and legs. High insulin levels also increase the incidence of cancers, stroke, and dementia. Reducing blood glucose levels with oral medications and insulin reduces risk of diabetic complications. There are several types of oral medications available for treating diabetes; however, they do not always control blood glucose adequately. In addition, these drugs have complications and are not used to treat insulin resistance and prediabetes - a condition when blood glucose is higher than normal but not high enough to be classified as diabetes. Prediabetes often progresses to diabetes over a period of months or years. Effective and safe treatments for insulin resistance may prevent the onset of diabetes or even reverse diabetes if diagnosed in its early stages before substantial damage to the pancreas has occurred. HP-211 is a botanical extract whose active ingredients are derived from herbs and vegetables present in normal diets. HP-211 has been shown in laboratory studies in cell culture, in animal studies, and in a previous Phase 1 study to enhance the ability of insulin to stimulate glucose uptake into cells. Thus, HP-211 may reduce the blood glucose and circulating insulin levels of subjects with type 2 diabetes after a meal. HP-211 may also reduce glucose and insulin responses to a greater extent in insulin-resistant as compared to insulin-sensitive subjects. Subjects will take 0, 1, 2 or 3 tablets of HP-211 in the morning and evening for 90 days. Hemoglobin A1c (HbA1c, or "A1c"), a measure of the average amount of glucose present in the blood, will be measured during the trial period.

Norfolk, NE18+ yrsAll genders
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Sentence Prediction in Developmental Language Disorder

Developmental Language Disorder

Millions of children - 7-12% of the school-age population - have developmental language disorder (DLD), a disorder that affects language learning, comprehension, and use. These children have difficulty with sentence production and comprehension at every stage of their development. These difficulties have major implications for the educational attainment of children with DLD compared to children with typical development (TD). Children with TD and adults make rapid predictions of upcoming words following verbs (e.g., predicting the patient in The dog eats the bone or the agent in The bone is eaten by the dog). Extensive work in children and adults indicates that prediction facilitates sentence comprehension by inducing a state of preparedness and contributes to language development by tuning the language system to the input. Children with DLD have a poorer ability to make sentence predictions, which may compound and result in sentence-comprehension deficits. Prior work on prediction deficits in DLD has focused on broad sentence characteristics like typicality or broad participant characteristics like vocabulary test scores. However, studies with typical individuals have identified more specific sentence- and participant-level contributors to sentence prediction. These factors have not been systematically explored in children with DLD. The investigators explore three separate hypotheses concerning factors that affect prediction in DLD. First, sentence- and participant-level properties affect prediction in children with DLD. Second, children with DLD lack robust representations of the underlying linguistic knowledge needed to predict, particularly abstract semantic features. Third, children with DLD have differences in event processing that relate to sentence prediction skill. The investigators investigate these hypotheses in 5-7-year-old school-age children with DLD across three Aims. Aim 1: Measure the effect of sentence- and participant-level properties on sentence prediction. The investigators will measure two participant-level cognitive factors (processing speed, verbal working memory) and their effect on prediction of agents and patients in sentences varying across two properties (syntactic complexity, semantic competition). Aim 2: Measure linguistic knowledge that underlies sentence prediction. The investigators will measure knowledge of agent-verb and verb-patient cooccurrences (e.g., dog-bite, eat-apple) and knowledge of verb-specific semantic features (e.g., throw-\<round object\>). Aim 3: Measure event-processing skills that underlie sentence prediction. The investigators will measure how children with DLD categorize and attend to agents/patients in visual scenes. Impact: This project has the promise to be highly impactful. First, it bridges disparate literatures on language processing in adults, children with TD, and children with DLD, providing clarity about predictive processing in DLD. Second, it may influence intervention approaches by identifying areas of strength and need in children with DLD. Third, it sets the stage for larger-scale longitudinal work examining effects of early prediction ability, language knowledge, and event processing on later sentence comprehension.

Omaha, NE5โ€“7 yrsAll genders
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CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes

End-Stage Kidney Disease ยท End-Stage Renal Disease

The investigators aim to determine, using a point-of-care randomized controlled trial design, if hemodialysis patients, who are randomized to metoprolol succinate (a dialyzable, beta-1 selective beta blocker), have an improved cardiovascular outcome compared to those randomized to carvedilol (a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties). The investigators will also examine intervention practices to identify components that best support engagement and sustainability.

Omaha, NE18+ yrsAll genders
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Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women

Heart Diseases ยท Coronary Artery Disease ยท Coronary Artery Bypass Grafting

The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.

Lincoln, Omaha +more, NE18+ yrsWomen
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A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine

Acute Treatment of Migraine

The purpose of the study is to learn about safety and how the body processes the study medicine called Zavegepant (PF-07930207) in children with a history of migraine. This study helps understand how the medicine is changed and removed from the body after taking it. This study is seeking participants who: * Are children aged between 6 and less than 12 years old * Have had migraine for at least 6 months. * Weigh more than 15 kilograms All participants in this study will receive zavegepant as a nasal spray once (one spray into one nostril). The dose of the study medicine that each participant receives will depend on how much the participant weighs. The study will look at the experiences of the participants receiving the study medicine and collect data to better understand the possible benefits and unwanted effects of different doses of the study medicine. Participants will take part in this study for up to 10 weeks. During this time, they will have 3 study visits at the study clinic, and 2 follow-up phone calls.

Omaha, NE6โ€“11 yrsAll genders
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A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.

Pressure Ulcer, Stage IV ยท Osteomyelitis

The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.

Omaha, NE18+ yrsAll genders
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Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Amyotrophic Lateral Sclerosis

The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is: Does pridopidine slow disease progression of ALS? Researchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS. Participants will: Take pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks. Visit the clinic once every 1-3 months for checkups and tests

Lincoln, NE18โ€“80 yrsAll genders
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A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer

Small Cell Lung Cancer

PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1/PD-1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior treatment regimens. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.

Grand Island, NE18+ yrsAll genders
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A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer

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).

Lincoln, NE18+ yrsAll genders
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