Palm Harbor

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation CIC. This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 23, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone TSH levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

Researchers are studying the effects of camlipixant in adults with two types of irritable bowel syndrome IBS-D diarrhea-predominant and IBS-M mixed type. This Phase 2b trial aims to assess how well camlipixant works and how safe it is when compared to a placebo. The study includes two parts, where after the first part, some participants may be randomly assigned to receive a higher dose of camlipixant or stop taking the drug. Participants receive camlipixant at different dose levels or a placebo during the first part of the study. In the second part, all participants are randomized again to either continue with camlipixant or placebo. The treatment lasts up to 26 weeks, with doses adjusted in the second phase. The study uses a triple-blind design where neither participants nor researchers know who receives which treatment during the trial. During the study, participants will regularly report their abdominal pain intensity and stool form using specific scoring systems. Researchers will monitor safety by tracking adverse events and changes in vital signs and laboratory tests. The main outcome measures focus on changes in abdominal pain intensity over weeks 7 to 12. Participants will be assessed throughout the 26-week period to evaluate the treatments effects and safety.

This study aims to collect prospective safety and effectiveness data for the C-Brace System, a microprocessor-controlled knee ankle foot orthosis, following standard care practices. The research focuses on patients with lower extremity pareses who are fitted with the C-Brace device. The goal is to better understand how the C-Brace influences walking speed, balance, risk of falling, and confidence in balance over time. The C-Brace is a custom-made device with thigh, calf, and foot components connected by an ankle joint or spring element. It uses sensors to continuously monitor knee joint movement and walking phases, adjusting hydraulic resistance and knee motion accordingly. Patients enrolled in the registry will undergo baseline evaluation, fitting, training or therapy sessions, and follow-up visits at 6, 12, 24, and 36 months after fitting. Participants will be assessed through various tests including timed walk tests, balance confidence scores, and mobility assessments at different intervals. The study also tracks falls related to device use and changes in activity levels with an activity tracker. Data collected will help characterize the safety and functional impact of the C-Brace over three years of follow-up.

This research aims to evaluate the efficacy, safety, and tolerability of Suzetrigine in adults experiencing pain related to diabetic peripheral neuropathy DPN. The study focuses on participants with type 1 or type 2 diabetes who have had bilateral lower extremity pain from DPN for at least one year, seeking to understand how Suzetrigine impacts their pain levels compared to placebo. Participants will be randomly assigned to one of two groups those receiving Suzetrigine tablets and those receiving a matching placebo, both taken orally. The study uses a parallel design and is conducted in a double-blind manner to assess the treatment effects over a 12-week period. During the study, participants will have their daily pain intensity measured using the Numeric Pain Rating Scale NPRS and physical health status assessed via the SF-36 questionnaire. Researchers will monitor changes from baseline to week 12 to evaluate the treatment impact. The study spans from screening through 12 weeks of treatment, with safety and tolerability closely observed throughout this period.

Researchers are evaluating the effects of YB-101 on thyroid function in adults with Graves Disease. The study aims to assess how safe and well tolerated YB-101 is, as well as how it is distributed in the body. This Phase 2 trial includes participants with a documented diagnosis of Graves Disease confirmed by thyroid-stimulating hormone receptor antibodies. The study has two parts Part 1 is a blinded treatment period and Part 2 is a double-blinded treatment period. Participants will receive either YB-101 or a placebo through subcutaneous injections over a 24-week period. Those who participate in Part 1 are not eligible to participate in Part 2. The treatments and placebo are administered similarly in both parts. Participants will attend between 34 to 39 in-clinic visits over approximately 40 weeks depending on their assigned part. Researchers will monitor side effects, safety, and thyroid hormone levels including free triiodothyronine FT3, free thyroxine FT4, and thyroid-stimulating hormone TSH. They will also evaluate the proportion of participants who normalize these hormones and stop anti-thyroid drugs. The study includes safety assessments up to Day 169 and ongoing monitoring throughout the treatment period.

Migraine is a common neurological disorder that causes moderate to severe headache attacks, often with nausea, vomiting, and sensitivity to light and sound. This study is evaluating 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 trial includes two participant groups a pharmacokinetic PK cohort for dose analysis in younger children and a main study cohort involving randomized treatment with different ubrogepant doses or placebo. Participants aged 6 to 11 years in the PK cohort will receive one of two doses of ubrogepant to determine dosing for the main study. In the main study, children aged 6 to 11 and adolescents aged 12 to 17 will be randomly assigned to low or high doses of ubrogepant or placebo, with a one in three chance of receiving placebo. For qualifying migraine attacks, participants will take oral tablets of the assigned study treatment, with the option of a second dose or rescue medication at least two hours later if headaches remain moderate or severe. Participants will be involved for up to six months and will attend regular hospital or clinic visits. Researchers will monitor treatment effects using medical assessments, blood tests, side effect checks, and questionnaires. The primary outcome measured is the percentage of participants achieving pain freedom two hours after the initial dose. Safety, tolerability, and pharmacokinetic data will also be collected to understand ubrogepants effects in this younger population.

Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for adults with colorectal cancer that has spread to other parts of the body. The study aims to understand how well this new combination works compared to an existing treatment using Bevacizumab with chemotherapy. The study is a phase 3, double-blind, randomized trial focusing on treatment effectiveness and safety in participants who have not received prior systemic therapy for metastatic disease. Participants are randomly assigned to one of two groups. One group receives PF-08634404 with chemotherapy, and the other group receives Bevacizumab with chemotherapy. Both treatments are given through intravenous IV infusions in cycles. Treatment continues as long as it helps and side effects are manageable. Treatments are administered at clinical sites by trained staff. Participants will have regular visits for treatment, health evaluations, and various tests. After stopping treatment, there is a follow-up visit about 30 to 37 days later to review health and side effects. Further follow-up occurs every 12 weeks by phone, in person, or via health record review to monitor health status and any new treatments. The study duration for each participant is approximately 33 months. Researchers will measure progression-free survival, overall survival, response rates, quality of life, and monitor safety throughout the study.