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Discover 17,687 clinical trials near Maryland. Find research studies in your area.
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NCT03028740
The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.
NCT03468660
Older people experience great difficulty understanding speech, especially accented English, and this problem is expected to increase with the influx of immigrants who provide services to the elderly population. The research examines the underlying factors that contribute to older listeners' difficulty understanding accented speech, including those associated with age-related hearing loss, changes in processing in auditory pathways in the brain, and general cognitive decline. The investigation also evaluates the efficacy of training strategies to improve understanding of accented English by older people. Outcomes of this research are expected to improve communication between senior citizens and those with whom they interact daily, and thereby improve quality of life for the older segment of the Nation's population.
NCT04280705
This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.
NCT00600015
This trial will investigate the use of the newer targeted agents erlotinib and sorafenib in patients with stage IIIB or stage IV NSCLC who have received 1-2 prior chemotherapy regimens. Patients will be randomized to receive erlotinib (150 mg/day) and sorafenib (400 mg twice daily), or erlotinib (150 mg/day) and a placebo.
NCT03151408
This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and cytogenetic low-risk AML, who are unfit to receive intensive remission induction chemotherapy due to age ≥ 75 years or comorbidities. Patients will be randomized in a 1:1 ratio to one of two groups: Group A (experimental group) to receive pracinostat plus AZA and Group B (control group) to receive placebo plus AZA. Randomization will be stratified by cytogenetic risk category (intermediate vs. unfavorable-risk, according to SWOG Cytogenetic Risk Category Definitions) and ECOG performance status (0-1 vs. 2). Treatments will be administered based on 28-day cycles, with pracinostat/placebo administered orally once every other day, 3 times a week for 3 weeks, followed by one week of no treatment and AZA administered for 7 days of each cycle. Study treatment should continue until there is documented disease progression, relapse from complete remission (CR), or non-manageable toxicity. A minimum of 6 cycles may be required to achieve a complete remission. Once permanently discontinued from study treatment, patients will enter the Long-term Follow-up phase of the study and will be followed for assessment of disease progression, if applicable, and survival every 3 months (±1 month) until death. The end of this study is defined when 390 events (deaths) have occurred and the study is unblinded for final overall survival analysis. Patients who are receiving study treatment at the end of the study may have the opportunity to continue to receive the study drugs to which they were randomized to (Post- Study Observation Period), until the Sponsor informs the Investigators of the appropriate course of action based on the study results. The Post-Study Observation Period is defined as the period starting from the end of the study for a maximum of 12 months.
NCT04209621
Background: Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are cancers often treated with the drug ibrutinib. For some people, ibrutinib stops working. Researchers want to see if adding another drug can help. Objective: To test how people with ibrutinib-resistant CLL respond to duvelisib. Eligibility: People ages 18 and older with CLL or SLL that is no longer responding to ibrutinib or has developed mutations that could stop it from working Design: Participants will be screened with: * Medical history * Physical exam * Heart tests * Blood and urine tests * CT scan. For this, participants will have a dye injected into a vein. They will lie in a machine that takes pictures of the body. * Bone marrow biopsy. For this, a needle injected into the participant s bone will remove marrow. * Optional lymph node biopsy. For this, the participants whole lymph node or part of it will be removed through the skin. * Optional lymphapheresis. For this, the participants blood is removed through a vein in one arm, the white blood cells separated out, and the blood returned through a vein in the other arm. Participants will take duvelisib twice daily by mouth. They will continue ibrutinib at their current dose for the first 6 months. They will continue to take duvelisib until their CLL/SLL stops responding or they develop intolerable side effects. Participants will take an antibiotic and antiviral medication. They may take steroids. Participants will have blood tests every 2 weeks during the first 2 months. Participants will have monthly follow-up visits during the first 6 months and every 3 months thereafter. These will include repeats of some of the screening tests.
NCT01690299
This study will test the clinical effectiveness and safety of apremilast compared with placebo as well as etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis.
NCT04125368
Alive \& Thrive (A\&T) is an initiative that supports the scaling up of nutrition interventions to save lives, prevent illnesses, and contribute to healthy growth and development through improved maternal nutrition, breastfeeding and complementary feeding practices. In Ethiopia, A\&T integrated a package of maternal nutrition interventions into existing antenatal care (ANC) services delivered through government health facilities (counselling on diet quality during pregnancy, distribution and promotion of iron-folic acid (IFA) supplementation, weight gain monitoring, counselling on early breastfeeding practices, and systems strengthening through training and supportive supervision) and community platforms (home visits, Pregnant Women Conferences/Mother Support groups, and community gatherings). The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys in 2019 and 2021.
NCT04155437
Alive \& Thrive (A\&T) is an initiative that supports the scaling up of nutrition interventions to save lives, prevent illnesses, and contribute to healthy growth and development through improved maternal nutrition, breastfeeding and complementary feeding practices. In Burkina Faso, A\&T developed an intensive package of maternal nutrition interventions to be integrated into existing ANC services delivered through government health facilities that align with the latest global evidence. These included intensified counseling and support on dietary diversity and quality during pregnancy, iron-folic acid (IFA) supplements consumption, importance of ANC and increasing the number of visits, adequate weight-gain monitoring, and early initiation of and exclusive breastfeeding. The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys of pregnant and recently delivered women (i.e. with a child under 6 months of age) in 2019 and 2021.
NCT01211418
Cocaine addiction continues to be a major problem in the U.S. with no FDA-approved pharmaceutical therapy. Finding effective treatment for cocaine addiction has long been a challenge to scientists and clinicians. Psychosocial interventions known as behavior therapies are the cornerstone of cocaine addiction treatment. However, there is an urgent need to further improve treatment outcomes, especially during early recovery and the protracted withdrawal phase of the treatment since many patients drop out or relapse during this phase. Our clinical experience and studies suggest that integrative Meditation (IM) helps reduce cravings and withdrawal symptoms and increases treatment retention. The benefit of IM is well supported by tension-reduction theory and attention-networks framework in addiction treatment. The proposed study will implement a therapy development study to add IM as a self-care component to the current outpatient treatment of cocaine addiction to improve treatment outcomes. The specific aims of the proposed study include: 1) to conduct a 12-week controlled trial with outpatient cocaine users to assess feasibility of recruiting and retaining cocaine addicts and to determine effect size of IM-augmented treatment in comparison with Nondirective Therapy (NT) control, with both groups receiving standard outpatient treatment as usual (TAU), thereby facilitating future larger scale therapy development study; and 2) to examine the changes in attention networks and negative mood as possible mediators of treatment outcomes between the two groups.
NCT01182727
Being obese is a common problem for people with schizophrenia. People with schizophrenia are more likely to be overweight compared to the general population. Being overweight is a major risk factor for developing type II diabetes. Approximately 15% of people with schizophrenia have type II diabetes. People with type II diabetes have problems with their body's insulin. Insulin is a hormone produced by the body to control blood sugar level. Obesity and type II diabetes are strong risk factors for heart disease. In type II diabetes the body does not respond to insulin correctly. Obesity, type II diabetes, and insulin resistance are all common states of inflammation. Inflammation is a reaction by the body to irritation, injury, or infection. Salicylates are non-steroidal anti-inflammatory drugs. Aspirin is an example of a salicylate. These drugs work by decreasing the level of inflammation in the body. Salicylates have been shown to decrease inflammation and improve the body's response to insulin. Improving the body's response to insulin and decreasing inflammation could possibly reduce the risk of developing type II diabetes. Salicylates have been known for years to be effective for the treatment of diabetes. Salicylates increase the body's response to insulin causing blood sugar levels to decrease. Many salicylate drugs have side effects including stomach irritation and increased risk of bleeding. The drug for this study is called salsalate and is different from other salicylates. Salsalate has a lower bleeding risk than aspirin. Salsalate has been used to treat arthritis and has been shown to be safe. There have been no studies using salsalate in people with schizophrenia. The purpose of this study is to gain experience in the use of salsalate in people with schizophrenia. The study would be a pilot study to obtain preliminary data. The study would be a 6-week study where everyone in the study would receive the drug salsalate. The participants in the study will have tests of baseline symptoms of schizophrenia, a physical exam, EKG (to check heart function), and a side effect checklist for possible side effects from salsalate. The study will also have some blood drawn to measure blood sugar levels, insulin levels, and inflammatory markers.
NCT02745535
This study will evaluate the safety, tolerability, and efficacy of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C infection who have failed to eradicate hepatitis C despite previous combination directly acting antiviral therapy.
NCT03147222
This pilot study will evaluate the feasibility of implementing an intervention in the home setting that is specifically designed to coach and mentor caregivers as they assist individuals with Alzheimer's disease and related dementia (ADRD) who have fractured a hip to perform everyday activities and engage in more physical activity.
NCT01431157
Sleep apnea syndrome is clinically defined by frequent pauses in breathing during sleep and symptoms, such as being tired. It can decrease the restfulness of sleep and decreases the level of oxygen in the blood. Sleep apnea patients suffer from daytime sleepiness, hypertension, coronary artery disease (CAD), stroke, ischemic heart disease, arrhythmias, pulmonary hypertension, heart failure, and premature death. There is significant evidence suggesting that nighttime decreases in blood oxygen levels are the primary cause of many of the abnormalities associated with this disease. Epidemiological studies have demonstrated a surprisingly high prevalence of sleep apnea. Mild sleep apnea is present in 17% of adults in the general population and moderate to severe sleep apnea is present in 5.7% of adults. Among patients with heart failure the prevalence skyrockets. Multiple studies have found the prevalence of moderate to severe sleep apnea to be anywhere from 11-53% in heart failure patients. Continuous positive airway pressure (CPAP) therapy is currently the standard of care for sleep apnea sufferers regardless of the severity of their disease. In patients without heart failure, CPAP therapy has numerous benefits and several long term studies have reported that CPAP causes less cardiovascular disease as well as a long term improvement in cardiovascular symptoms and mortality among patient with severe sleep apnea. In heart failure patients, CPAP has shown some beneficial short term effects but evidence of long term improvements in symptoms and mortality are lacking. Compliance with CPAP therapy reduces systolic blood pressure, improves cardiac function, raises oxygen levels, and increases exercise tolerance. On the other hand, CPAP has not been shown to affect survival or number of hospitalizations in heart failure patients. Moreover, compliance with CPAP is often poor and many people cannot tolerate it. This further limits the therapeutic effectiveness of this intervention. The purpose of this study is to assess whether nocturnal oxygen administration via nasal cannula alone can improve outcomes in congestive heart failure patients with moderate to severe sleep apnea. The effects of nocturnal oxygen administration will be assessed by using biomarkers of heart stress and markers of whole body inflammation.
NCT04056299
To determine the efficacy and safety of AR201 in a characterized oral desensitization immunotherapy (CODIT™) regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive.
NCT00500071
Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
NCT01974609
The purposes of this noninferiority randomized clinical trial are to: 1. determine whether the most commonly used commonly used non-narcotic analgesic (ibuprofen 600 mg + acetaminophen 325 mg) provides pain relief that is not unacceptably worse than the most commonly prescribed narcotic containing analgesic (hydrocodone 5 mg. + acetaminophen 325 mg, equivalent to Norco 5/325) in patients undergoing carpal tunnel release. 2. Determine whether the following covariates affect pain level following surgery or medication usage: gender, country (US/Canada), pre-operative CTS symptoms, site, workers compensation status and employment status (employed/self-employed/unemployed-able to work/unemployed-unable to work)
NCT04469140
The investigators wish to better understand the role of the choriocapillaris (CC) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the CC could prove useful as an anatomic clinical trial endpoint in future drug trials.
NCT03688243
NCT03371251
This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams \[mg\], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on limited background standard of care treatment, in order to estimate the optimal dose. BOS161721 at the chosen dose will be compared to placebo for response on the SLE Responder Index 4, with sustained reduction of oral corticosteroids, in the same participant population.
