Waxahachie

Migraine is a condition that often causes moderate to severe headaches on one side of the head, sometimes with throbbing pain, nausea, vomiting, and sensitivity to light and sound. This study evaluates the safety and effectiveness of atogepant, a medicine approved for preventing migraines in adults, to see how well it works compared to placebo in preventing chronic migraines in participants aged 12 to 17 years. The study is a phase 3, double-blind trial where neither the participants nor the doctors know who receives the medicine or placebo. Participants will be randomly assigned to receive either oral atogepant tablets or placebo tablets once daily for 12 weeks. Following the treatment period, there will be a 4-week follow-up phase. The study involves about 420 participants at approximately 70 sites worldwide. Throughout the study, participants will visit hospitals or clinics regularly to complete daily diaries, undergo medical assessments and blood tests, report any side effects, and complete questionnaires. Researchers will measure the number of participants experiencing adverse events and track changes in the average monthly number of migraine days from the start of the study through week 12.

Researchers are evaluating the safety and effectiveness of low-dose and high-dose atogepant in children and adolescents aged 6 to 17 who experience episodic migraine. Migraines are moderate to severe headaches often accompanied by symptoms such as throbbing pain, nausea, and sensitivity to light and sound. While several treatments exist for adults, options for younger patients are limited, making this Phase 3 study important to understand how atogepant works in this younger population. Participants aged 6 to 17 will be randomly assigned to one of six groups to receive either placebo, low-dose atogepant, or high-dose atogepant tablets taken once daily by mouth for 12 weeks. The exact doses for children aged 6 to 11 will be decided after a pharmacokinetic substudy. After 12 weeks, participants may either have a follow-up visit 4 weeks after stopping the treatment or join an extension study to continue taking atogepant for an additional 52 weeks. During the study, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and to monitor for any side effects. They will also complete questionnaires to evaluate how treatment affects their migraines. The main outcomes measured are changes in the number of monthly migraine days over 12 weeks and the number of participants experiencing adverse events during the first 16 weeks. About 450 participants will be enrolled across roughly 100 sites worldwide.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

Researchers are evaluating the safety, tolerability, pharmacodynamics, and efficacy of multiple ascending doses of CNP-103 in adolescents and adults aged 12 to 35 years who have been recently diagnosed with Stage 3 Type 1 Diabetes within the past 6 months. This Phase 1b/2a first-in-human clinical trial aims to better understand how CNP-103 affects this population and to monitor any immune-related safety concerns. Participants will receive either CNP-103 or a placebo (0.9% sodium chloride injection) over a 90-day treatment period following a 28-day screening phase. The study includes multiple dose cohorts with weight-based eligibility criteria and requires participants to continue standard diabetes management including insulin therapy, nutrition plans, and exercise as appropriate. After treatment, participants will undergo post-dose evaluations lasting 275 days to monitor long-term safety and effects. Throughout the approximately 393-day study, participants will attend visits for assessments including safety and immune monitoring, pharmacodynamics evaluations, and efficacy measurements. Researchers will closely track adherence to medication and monitor laboratory tests, while safety and immune responses will be evaluated from Day 1 through Day 365. This comprehensive follow-up aims to gather detailed information on the participant's health and response to the investigational treatment over time.

Researchers are evaluating whether using intravascular ultrasound (IVUS) imaging during minimally invasive treatment of leg arteries improves clinical outcomes in patients with symptomatic peripheral artery disease (PAD) classified as Rutherford class 2-5. This prospective multicenter randomized controlled trial in the U.S. focuses on lower extremity arterial disease, aiming to compare IVUS-guided interventions against standard angiography-guided treatments. Participants will receive either IVUS-guided endovascular treatment involving atherectomy, balloon angioplasty, and/or stent placement with IVUS imaging before and after the procedure, or standard angiographic-guided intervention without IVUS. The study targets lesions in iliac, femoropopliteal, profunda, or supramalleolar below-the-knee arteries, including some extending into the abdominal aorta and inframalleolar below-the-knee regions. During the study, participants will be monitored from enrollment through 6 months to assess primary patency, which measures the openness of the treated artery over time. The trial involves clinical evaluations and imaging assessments to compare the effectiveness of IVUS guidance versus standard angiography in maintaining artery patency after intervention.

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.

Menstrual migraine is a type of moderate to severe headache occurring around the time of menstruation, often accompanied by symptoms like nausea, vomiting, and sensitivity to light and sound. This trial evaluates the safety and effectiveness of ubrogepant, a drug being studied as a short-term preventive treatment for menstrual migraine. Adult women who experience migraine attacks in at least two out of three menstrual cycles are invited to participate in this Phase 3 study. Participants will be randomly assigned to receive either oral ubrogepant tablets or a placebo once daily for 7 consecutive days, starting 3 days before the expected start of their period, across three menstrual cycles during a 16-week double-blind treatment phase. Those who qualify may continue taking ubrogepant daily for 7 days per cycle during a 52-week open-label extension. The study involves about 496 women at around 100 sites across the United States and Puerto Rico. Throughout the study, participants will record daily information in electronic diaries and attend regular clinic visits. Researchers will monitor treatment effects through medical assessments, blood tests, questionnaires, and side effect checks. The main outcomes measured include changes in the number of migraine days during perimenstrual periods over 16 weeks and the number of participants experiencing adverse events up to approximately 68 weeks.

Migraine is a common neurological disorder causing moderate to severe headaches, often with nausea, vomiting, and sensitivity to light and sound. It is especially disabling in children and adolescents. This trial evaluates the safety and effectiveness of ubrogepant, a drug approved for adults, for the acute treatment of migraine in children and adolescents aged 6 to 17 years. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Participants aged 6 to 11 years in a pharmacokinetic (PK) cohort will receive one of two doses of ubrogepant to determine the best dose for the main study. In the main study, children and adolescents will be randomized to receive either a low or high dose of ubrogepant or a placebo, with a one in three chance of receiving placebo. The study treatment is given as oral tablets during qualifying migraine attacks, with an option for a second dose or rescue medication at least 2 hours after the initial dose if the headache remains moderate or severe. Approximately 1059 participants will be enrolled across about 120 sites in the United States. Participants will attend regular hospital or clinic visits throughout the study, which lasts up to 6 months. Researchers will monitor the effects of the treatment through medical assessments, blood tests, side effect checks, and questionnaires. The primary outcome is the percentage of participants aged 6 to 17 years who experience freedom from pain 2 hours after the initial dose. The study includes safety monitoring and evaluates tolerability and pharmacokinetics of ubrogepant in this age group.

Researchers are evaluating the safety, effectiveness, and tolerability of tenapanor in children aged 12 to less than 18 years who have irritable bowel syndrome with constipation (IBS-C). This Phase 3 study is randomized, double-blind, and placebo-controlled, aiming to compare two doses of tenapanor (25 mg and 50 mg) taken twice daily over 12 weeks. The study includes an initial 2-week screening period to confirm eligibility and collect daily symptom data via an electronic diary (eDiary).

Researchers are creating the Texas Immuno-Oncology Biorepository (TIOB) to collect and store carefully documented samples of tissue, blood, urine, and stool from cancer patients. These samples are collected over time from patients receiving standard surgical treatments or FDA-approved immunotherapy across the largest non-profit health system in Texas. The study involves a diverse group of patients with various racial, social, and ethnic backgrounds, linking clinical and imaging data with these biospecimens throughout their cancer journey, making TIOB a unique research resource. The TIOB aims to establish a facility that gathers, processes, and stores biospecimens alongside detailed clinical and radiological information. This resource will support many types of research, including studies of tissue structure, genetic and molecular analysis, protein studies, immune cell investigation, and advanced transcriptomics. It will enable integration of multiple biological data types, including genomics, epigenomics, proteomics, radiomics, metabolomics, and microbiomics, to better understand cancer's complex biology. Participants provide consent to donate their biospecimens, which are collected serially to build a long-term biorepository over 15 years. Researchers will analyze these samples and matched clinical information to identify immunological and molecular biomarkers that may predict how patients respond to cancer therapies. This ongoing collection and detailed annotation support future studies on cancer treatment outcomes and patient characteristics.