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Found 8 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of duvakitug in people with moderately to severely active Crohn's Disease. The study focuses on maintaining clinical remission and endoscopic response in participants who have already shown clinical improvement. Participants will receive either duvakitug or a placebo through subcutaneous injections during the 40-week pivotal maintenance period. Those who complete this phase may continue treatment in a 240-week open-label extension, making the total treatment duration up to 280 weeks. The entire study period can last up to 286 weeks, including a 45-day follow-up visit after treatment ends. Participants will attend up to 43 onsite visits throughout the study, including 21 in the maintenance phase and 22 in the extension phase. Researchers will evaluate clinical remission using the Crohn's Disease Activity Index and endoscopic response at Week 40. Safety and efficacy will be closely monitored during treatment and follow-up visits to understand long-term outcomes for people living with Crohn's Disease.

Age: 16Years - 80YearsAll GendersPhase 3
15 locations
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Actively Recruiting

Researchers are investigating whether treating children with amblyopia using spectacles and patching at the same time leads to similar vision improvement compared to treating first with spectacles alone and then adding patching if needed. This randomized Phase 3 trial focuses on children aged 3 to under 13 years who have not been treated for amblyopia before. The study looks at amblyopia caused by differences in eye focusing (anisometropia), eye misalignment (strabismus), or both. At the start, children's vision will be tested with trial glasses based on a recent eye exam. Eligible children will receive new glasses and return for a baseline visit after wearing them for at least 10 minutes to confirm eligibility. Then they will be randomly assigned to either the sequential group (glasses first, patching added if needed) or the simultaneous group (glasses and patching together). Follow-up visits will happen every 8 weeks for up to 56 weeks, with vision tested each time to track improvement or stability. Patching will be monitored using an occlusion dose monitor (ODM). Throughout the study, vision in the amblyopic eye will be regularly measured to assess changes. Participants will be categorized as improving or stable/worsening at each visit. Those with stable or worsening vision and remaining amblyopia in the sequential group will begin patching and continue follow-up visits. Treatment adjustments will be made based on investigator judgment. The main outcome is the average change in distance visual acuity in the amblyopic eye after 56 weeks of treatment. The study ends after the final 56-week visit.

Age: 3Years - 13YearsAll GendersPhase 3
68 locations
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Actively Recruiting

Healthy Volunteer

This research aims to evaluate physical exercise as a treatment option for college students with Attention Deficit Hyperactivity Disorder (ADHD). The study focuses on whether sprint interval training (SIT) can improve executive functioning, such as sustained attention and working memory, more in students with ADHD compared to those without ADHD. The rationale is that exercise might offer a low-cost, low-risk alternative to current treatments like stimulants or therapy, while also providing additional health benefits such as increased fitness and reduced obesity. Participants will attend two in-lab experimental appointments in a counterbalanced order: one with sprint interval training and one without exercise. During the exercise session, participants will warm up with stretches and low-intensity cycling, then complete 16 minutes of high-intensity intervals on a cycling ergometer, followed by a rest period before performing cognitive tasks. The non-exercise session involves completing the same cognitive tasks without prior exercise. The study will monitor heart rate and perceived exertion to confirm exercise intensity. Participants will complete cognitive tests of attention and memory during both appointments, including the Continuous Performance Task, Digit Span, Letter-Number Sequencing, and Spatial Span. They will also fill out mood and ADHD symptom questionnaires the morning after each appointment. Researchers will analyze changes in cognitive performance between exercise and non-exercise sessions to assess the immediate effects of sprint interval training on executive functioning. The study includes 48 college students aged 18 to 29 years, equally divided between those with and without ADHD, and includes safety screenings for exercise suitability.

Age: 18Years - 29YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the immediate effects of stimulant medication on executive functioning in college students, comparing those with ADHD to those without the condition. The study aims to understand how stimulants affect cognitive abilities like working memory and sustained attention and to help prevent stimulant misuse among students without ADHD. It is a Phase 2 study involving 40 students from the University of Wyoming and Laramie County Community College, equally divided between those with and without ADHD, and balanced by gender. Participants will take part in three appointments: a baseline session, and two experimental sessions where they will receive either a placebo or a stimulant medication (Adderall IR 10mg). The order of these experimental sessions will be randomized and counterbalanced. During each experimental session, participants will wait 90 minutes after taking the pill before completing tasks that measure executive function. Physiological monitoring such as heart rate and blood pressure will be conducted, and mood and sleep questionnaires will be completed the morning after each session. Throughout the study, participants will be asked to avoid caffeine, alcohol, nicotine, and illicit drugs for 12 hours before experimental appointments. Researchers will measure changes in cognitive tests including Continuous Performance Test, Spatial Span, Digit Span, and Letter-Number Sequencing, as well as mood and intentions related to stimulant use. Safety will be closely monitored with a medical consultant available during sessions. The total duration of involvement spans approximately three weeks with repeated assessments to evaluate the effects of stimulant versus placebo on cognition and mood.

Age: 18Years - 29YearsAll GendersPhase 2
1 location
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Actively Recruiting

Researchers are studying alcohol behaviors in college students aged 18 to 25 who drink alcohol regularly. The study aims to see if personalized goal setting about protective behavioral strategies (PBS) can increase how often students use these strategies to reduce risks and harms related to drinking. The study also examines whether more frequent use of these strategies leads to drinking less, fewer negative effects from alcohol, and more positive effects. Participants are divided into three groups: a control group, a PBS-only group, and a PBS+Goals group. All participants receive brief education about PBS. The PBS-only and PBS+Goals groups choose three new PBS to try over two weeks and pick a reminder method. The PBS+Goals group also learns about goal setting and picks two goals for each chosen strategy. After two weeks, participants complete follow-up assessments. Throughout the study, participants report their use of PBS, alcohol consumption, and related positive and negative consequences. They also share their confidence and motivation to change their drinking and strategy use. Those in the PBS-only and PBS+Goals groups report if they used their reminder method, and those in the PBS+Goals group indicate if they met their goals. The study measures these outcomes at the start and after two weeks.

Age: 18Years - 25YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

This study focuses on college students aged 18 to 29 who drink alcohol and experience cravings at least once a week. It aims to evaluate whether dynamic visual noise (DVN), a short video of rapidly moving black and white squares, can reduce alcohol cravings and consumption. The study also explores if changes in attentional bias toward alcohol, meaning how much attention is paid to alcohol compared to other things, play a role in reducing cravings and drinking. Participants will be randomly assigned to watch either DVN or static visual noise (SVN), which is a still image of black and white squares used as a control. Both DVN and SVN involve viewing an 80 x 80 grid of black and white pixel squares for at least 30 seconds daily. Participants can watch longer if they wish. They will watch these visuals every day for seven days, starting on the day of their initial laboratory visit. Participants will visit the lab once to provide baseline data. Following this, they will watch their assigned visual noise daily and complete daily follow-up assessments for six days, with a final follow-up on the seventh day. Researchers will measure alcohol craving strength, craving frequency, alcohol consumption, and attentional bias towards alcohol at baseline and after one week. This allows the study to understand the effects of the interventions over time.

Age: 18Years - 29YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Age: 18Years +All Genders
2284 locations
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Actively Recruiting

This research aims to develop and test a flexible physical activity maintenance program for cancer survivors after they complete a community-based exercise oncology program. The study evaluates how feasible and acceptable the program is for participants and community partners, using surveys, focus groups, and interviews. It also compares how many survivors meet exercise guidelines six months after finishing the initial exercise program. The goal is to understand what level of support is needed to help survivors maintain healthy exercise habits long-term. Participants first take part in a community-based exercise program that includes group aerobic and resistance sessions twice a week along with three physical activity behavior change discussion sessions. After finishing this program, they enter a three-month period without active intervention to live freely. Researchers then measure participants' physical activity to classify them as "Responders" (meeting exercise guidelines) or "Incomplete Responders" (not meeting guidelines). Based on this, participants are randomly assigned to one of three maintenance interventions involving monthly behavior change discussions and, for some, additional bi-weekly exercise sessions over 12 weeks. Throughout the study, researchers monitor physical activity levels at baseline, right after the exercise program (8 or 12 weeks), and at 3 and 6 months post-program. They use these measurements to assess how well participants maintain physical activity over time. The study also gathers feedback on the program's feasibility and sustainability from participants and community partners to inform future exercise programs for cancer survivors.

Age: 18Years +All GendersPhase Not Applicable
3 locations