Pompano Beach

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 HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating the safety and effectiveness of the Vagus Nerve Stimulation VNS Therapy System as an additional treatment for people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, and blinded trial compares active VNS therapy to a no stimulation control group in reducing depressive symptoms over 12 months. The study follows guidelines aligned with Medicare and Medicaid coverage decisions for VNS in this condition. Participants receive an implant of the VNS device and are randomized at least two weeks after implantation to either have the device activated or remain without stimulation for the first 12 months. After this initial period, those in the control group can begin stimulation. Following the 12-month randomized phase, all participants enter an open-label, longitudinal study lasting about five years, including new enrollees after the initial trial phase. During the study, participants are monitored through various depression rating scales, including the Montgomery sberg Depression Rating Scale MADRS, to assess response and remission rates up to 12 months. Safety is tracked by recording adverse events from implantation through the first year. Additional assessments include disability and health outcome scales, as well as suicidality tracking. The study aims to gather long-term data on treatment effects and participant well-being.

Researchers are evaluating a new care strategy for people at increased risk of atherosclerotic cardiovascular disease ASCVD but without symptoms. The study compares a Cleerly Coronary Artery Disease CAD Staging System-based care approach against the usual risk factor-based care to see if it better reduces cardiovascular events. This pragmatic, randomized trial addresses the need for improved methods to identify and personalize treatment for asymptomatic individuals at risk due to age, diabetes, prediabetes, or metabolic syndrome. Participants are randomly assigned to one of two groups. The risk factor-based care group receives usual care managed by their providers, while a cardiology team monitors and supports guideline-based treatment without revealing certain imaging results during the study. The Cleerly stage-based care group gets personalized management from a remote cardiologist-led team using the Cleerly CAD Staging System, which includes imaging to assess coronary atherosclerosis and guides pharmacotherapy and education. Treatment intensity may increase if plaque worsens after 24 months. During the study, participants will have assessments to monitor heart health and treatment adherence over an average of 3.5 years. Researchers will measure cardiovascular events and other related health outcomes to compare the two care strategies. The study involves ongoing medication monitoring, lab tests, and feedback to optimize prevention, with the goal of improving personalized care for cardiovascular risk management.

Researchers are evaluating the effectiveness and safety of a combination inhaler containing fluticasone propionate and albuterol sulfate, delivered via a multidose dry powder inhaler with an electronic module, in participants aged 12 years and older with asthma. This Phase 3 trial aims to compare this combination treatment to fluticasone propionate alone, albuterol sulfate alone, or a placebo inhaler. The study also assesses different dosing schedules, safety, tolerability, and pharmacokinetics of these inhalers. Participants will be randomly assigned to one of four groups receiving either the combination inhaler, fluticasone propionate inhaler, albuterol sulfate inhaler, or placebo, all with integrated electronic modules. Treatments are administered over a 4-week period with dosing four times daily. Pharmacokinetic assessments will be conducted after a single dose administration. The study is double-blind and placebo-controlled, with a parallel group design. Throughout the approximately 10-week study period, including screening and treatment, participants will undergo evaluations including lung function tests measuring forced expiratory volume in one second FEV1, asthma control questionnaires, and safety assessments. Researchers will monitor treatment-emergent adverse events and measure blood concentrations of the inhaled drugs. The study includes electronic monitoring of inhaler use and collects data at baseline, during treatment, and at week 4, with follow-up to assess efficacy and safety.

This trial evaluates the effectiveness of dotinurad compared with allopurinol in lowering serum uric acid levels in adults with gout-related hyperuricemia. The study focuses on reducing uric acid to below 6.0 mgdL after 24 weeks of treatment, addressing a common complication in gout patients. It is a phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years with a history of gout. Participants are randomly assigned to one of three groups one group continues allopurinol at their existing dose once daily through week 64 the second group receives dotinurad starting at 1 mg once daily for the first 4 weeks, then 2 mg once daily through week 64 the third group begins with 1 mg daily for 4 weeks, increases to 2 mg daily for 8 weeks, then continues 4 mg daily through week 64. All treatments are administered orally as over-encapsulated tablets. Throughout the study, participants undergo regular monitoring of serum uric acid levels and gout flares from baseline up to week 68. Assessments include measuring the percentage of participants achieving target uric acid levels at various points, gout flare rates, and treatment-emergent adverse events. The study also evaluates safety and tolerability over the course of the treatment period, which lasts up to approximately 68 weeks including follow-up.

Researchers are studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

This research aims to evaluate the safety and effectiveness of Icalcaprant in adults diagnosed with bipolar I or II disorder, specifically focusing on depressive episodes. Bipolar disorder is a chronic mood condition affecting a significant portion of the adult and pediatric populations in the United States. The study targets approximately 195 adult participants across about 35 sites in the U.S., aiming to understand how Icalcaprant impacts disease activity and adverse events. Participants are randomly assigned to one of three groups two groups receive different doses of oral Icalcaprant once daily for 6 weeks, and one group receives a matching placebo daily for the same period. After the treatment phase, all participants enter a 4-week safety follow-up period. The study uses a parallel design with quadruple masking to compare the effects of the investigational drug versus placebo. During the study, participants will attend regular visits at hospitals or clinics where they undergo medical assessments, blood tests, and complete questionnaires to monitor side effects and treatment effects. Researchers will measure changes from baseline to week 6 in depression severity using the Montgomery-sberg Depression Rating Scale and the Clinician Global Impression of Severity for bipolar disorder. Safety will be monitored up to approximately 10 weeks, ensuring participant well-being throughout the trial.

Researchers are evaluating the effects of a medicine called BI 1815368 in adults aged 18 and older who have a specific eye condition known as centre-involved diabetic macular edema CI-DME. This condition affects vision, and the study aims to find out if BI 1815368 can improve sight and to determine the best dose. The trial is a phase 2, randomized, double-masked, placebo-controlled study designed to assess efficacy, safety, and tolerability. The study has two parts. In the first part, participants are randomly assigned to one of two groups one receiving BI 1815368 tablets and the other receiving placebo tablets that look identical but contain no medicine. In the second part, participants are randomly assigned to one of four groups three groups receive different daily doses of BI 1815368, and one group receives placebo. All participants take the tablets twice daily for about 11 months. Participants stay in the study for about one year, during which they visit the study site 16 times. At these visits, doctors check vision, document any health problems, and take detailed eye pictures. Researchers compare changes over time between the groups to evaluate if the treatment affects vision. The main outcome measured is whether participants gain at least 10 Early Treatment Diabetic Retinopathy Study ETDRS letters in vision at Week 48 compared to baseline.

This observational study is focused on collecting data about the performance of CERAMENT BONE VOID FILLER, a synthetic biphasic bone graft substitute, when used in typical medical practice for orthopedic disorders. The study is sponsored by BONESUPPORT AB and aims to gather information on device performance and patient outcomes to understand its use in real-world settings. Participants will receive CERAMENT BVF as part of their treatment at approved healthcare centers following the products instructions for use. Data collection includes monitoring unexpected device performance, complaints, adverse events, and serious adverse events during surgery and continuing up to 18 months after treatment. Radiological assessments, pain scores, and quality of life evaluations will be conducted at intervals throughout the study. During the study, participants will undergo scheduled reviews at 6, 12, and 18 months to assess device-related outcomes and healing progress using imaging and questionnaires. Researchers will track safety events and gather patient-reported outcomes such as pain levels and quality of life. Participation involves following up with healthcare providers over this period to provide ongoing data for comprehensive evaluation of the devices performance.