Novi

Researchers are evaluating a mobile health application called SHIFT designed to improve sleep specifically for night shift workers who experience Shift Work Sleep Disorder. The goal is to establish evidence supporting fair access and effective use of this precision sleep medicine app by these workers. The study focuses on how SHIFT can help align workers' body clocks with their night shift schedules to improve sleep quality. The intervention involves using the SHIFT mobile app alongside an Apple Watch to collect data on individual body-clock timing. Based on this data, the app provides personalized recommendations for light exposure to help users adjust their circadian rhythms to their work schedules. The study includes participants who work at least four night shifts per month, with shifts starting between 6 PM and 2 AM and lasting 8 to 12 hours. Participants are expected to follow a set sleep schedule of 7 hours in bed after their night shifts and use the app's lighting recommendations. Participants will be monitored from enrollment through eight months, during which researchers will measure the impact of SHIFT on outcomes important to users. The study also compares the use experience and accuracy of the SHIFT app on Android devices versus the original iOS version. Data collection includes adherence to the app's recommendations and participant-reported sleep outcomes. This research aims to provide evidence for effective and equitable implementation of the SHIFT app to improve sleep in night shift workers.

Researchers are evaluating the clinical benefit, performance, and safety of a totally implantable cochlear implant (TICI) system in adults with sensorineural hearing loss. This condition involves damage to the inner ear or auditory nerve, leading to hearing impairment. The investigational device includes a microphone placed under the skin to capture speech and environmental sounds, allowing hearing without visible external parts. The study is pivotal and prospective, focusing on adults aged 18 years and older with bilateral sensorineural hearing loss. Participants will receive the totally implantable cochlear implant system, known as the TI1132 implant, which is designed to improve hearing function. The study is multi-center and pre-market, involving implantation surgery followed by activation of the device. The research will monitor speech recognition performance in quiet environments from before implantation through six months after activation, and will also track any adverse events or device issues up to 12 months post-activation. During the study, participants will undergo hearing tests, including word recognition assessments, and complete questionnaires to evaluate the device's impact on daily life and hearing ability. Safety and device performance will be closely monitored through scheduled follow-ups. The total duration of participant involvement includes preimplantation screening, implantation, activation, and up to one year of post-activation observation to assess both clinical outcomes and any potential complications.

Researchers are evaluating efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the study period.

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 (NT1) who have already been exposed to TAK-861 in earlier studies. The study also aims to observe improvements in symptoms such as excessive daytime sleepiness and the frequency of cataplexy episodes. This long-term extension trial continues from previous phase 2 and phase 3 trials and includes participants who completed those earlier studies. All participants in this trial will receive TAK-861 tablets. Those who were previously given a placebo in parent trials will be randomly assigned to a dose of TAK-861. The study plans to enroll up to 500 participants worldwide and will last approximately 5 years, or until the study is stopped or the drug is approved and launched. Participants will visit clinics multiple times, with some visits possibly done at home, and will have a follow-up check 4 weeks after their last dose. During the study, participants will be monitored for treatment-emergent adverse events from the time they consent until 4 weeks after their final dose, covering up to about 5 years. Researchers will assess safety and tolerability regularly through these visits and follow-ups. The focus is on identifying any side effects and understanding the long-term effects of TAK-861 in people with NT1.

Researchers are evaluating treatments for people with newly diagnosed multiple myeloma who are not candidates for or do not plan to have autologous stem cell transplant as initial therapy. The study compares the effectiveness of two new combination treatments: teclistamab with daratumumab and lenalidomide (Tec-DR), and talquetamab with daratumumab and lenalidomide (Tal-DR), against the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd). This is a Phase 3 randomized study designed to assess which treatment better controls the disease. Teclistamab, talquetamab, and daratumumab are given as subcutaneous injections, while lenalidomide is taken orally. Dexamethasone can be given either orally or by intravenous injection. Participants receive one of the three treatment combinations as assigned by the study. The treatments are administered regularly over the study period, with close monitoring and follow-up to evaluate outcomes. The study includes up to 9 years of follow-up to track disease progression and survival. Participants will undergo regular assessments including monitoring for disease progression and treatment response. Key measures include progression-free survival from the time of randomization and the presence of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also tracked throughout the study. Total participation time includes treatment and extended observation to assess long-term outcomes and side effects.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to standard chemotherapy, with or without radiation, can improve survival for patients aged 5 to 60 years with newly diagnosed stage I or II classical Hodgkin lymphoma. This phase III trial compares outcomes in groups based on their early response to initial chemotherapy, aiming to understand if immunotherapy can lead to better progression-free survival and overall survival compared to standard treatment alone. The study also looks at side effects, quality of life, and long-term health impacts across different patient groups. Participants first receive two cycles of standard ABVD chemotherapy every 28 days, followed by imaging to classify their response as rapid or slow early responders and their risk status as favorable or unfavorable. Based on these factors, patients are assigned to one of eight treatment arms that include either continued standard chemotherapy regimens or immunotherapy with brentuximab vedotin and nivolumab, sometimes combined with involved-site radiation therapy. Treatments are given intravenously or orally depending on the drugs, and cycles typically last 28 days. Imaging and blood samples are collected regularly throughout the study. Throughout the trial, participants undergo frequent scans such as FDG-PET, CT, MRI, and PET-CT to monitor their disease status. Blood samples and questionnaires assess treatment effects and quality of life. After completing treatment, patients have scheduled follow-up visits every 3 months for the first year, then every 6 months for two years, and annually up to 12 years to track long-term outcomes, side effects, and survival. The main measurements focus on progression-free survival, overall survival, treatment-related adverse events, and patient-reported experiences.

Researchers are evaluating the optimal doses of E2086, an oral tablet, compared to a matching placebo in adults with narcolepsy to reduce excessive daytime sleepiness. This phase 2 randomized, double-blind, placebo-controlled trial focuses on measuring sleepiness using the Mean Sleep Latency (MSL) from four maintenance of wakefulness tests (MWTs). Participants include adults diagnosed with narcolepsy type 1 or type 2, with specific clinical and diagnostic criteria based on the 2023 International Classification of Sleep Disorders. Participants receive either E2086 or placebo tablets during the study. The treatment period lasts four weeks, during which participants complete the MWTs to assess changes in sleep latency. The study monitors the effect of the drug on daytime sleepiness compared to placebo and evaluates safety and tolerability. During the trial, participants will undergo assessments including sleep diaries, clinical history reviews, and MWTs at baseline and week 4. Researchers will measure changes in mean sleep latency to evaluate treatment effect. Safety monitoring includes tracking adverse events and clinical observations throughout the study. The total participation time includes screening, treatment, and follow-up assessments as required by the protocol.

Researchers are evaluating the safety and effects of the study medicine PF-07799933 in people aged 16 and older who have advanced solid tumors with specific BRAF gene alterations. The trial includes participants whose cancers have progressed despite available treatments. This phase 1 open-label study aims to learn about the tolerability, pharmacokinetics, and anti-tumor activity of PF-07799933 given alone and combined with other study medicines. All participants will receive PF-07799933 tablets twice daily. Depending on the tumor type and study part, some participants may also receive binimetinib tablets twice daily, or cetuximab injections weekly or every two weeks in the clinic. Participants with colorectal cancer may also receive mFOLFOX6 chemotherapy, which includes fluorouracil, leucovorin, and oxaliplatin given intravenously. The study involves dose escalation and expansion phases, with treatment lasting about 2 years. Participants will attend regular clinic visits for monitoring during treatment. Researchers will assess dose-limiting toxicities, adverse events, changes in laboratory tests, vital signs, and physical exams from baseline through 28 days after the last dose. Dose interruptions, modifications, and discontinuations due to side effects will be tracked up to 2 years. The overall response rate to treatment will also be measured during this period.

Researchers are evaluating the safety, side effects, and best dose of the drug cabozantinib combined with standard chemotherapy in treating patients newly diagnosed with osteosarcoma. This study aims to compare the effect of adding cabozantinib to the usual chemotherapy drugs methotrexate, doxorubicin, and cisplatin. Cabozantinib is a kinase inhibitor that may slow tumor growth by blocking signals involved in blood vessel formation and growth pathways. The trial includes both phase II and phase III components and involves patients with localized or metastatic high-grade osteosarcoma, including those with pelvic tumors or unresectable disease. During the feasibility phase, patients received cabozantinib orally and standard chemotherapy intravenously in a series of induction, consolidation, and maintenance cycles over several months. In the efficacy phase, patients are randomized into groups receiving either standard chemotherapy alone or combined with cabozantinib, with treatment cycles lasting 35 days each followed by local control procedures like surgery. The study monitors the impact of adding cabozantinib on event-free survival and overall survival. All participants undergo imaging (X-ray, CT, MRI, PET or bone scan) and blood sample collection at diagnosis and throughout the trial. Participants are closely monitored through scans and blood tests at various time points to assess treatment effects and safety. Researchers measure dose-limiting toxicities during the initial 6 weeks and track event-free survival and overall survival for up to five years after completing treatment. The study also collects tumor tissue and blood samples to study tumor DNA and assess response to therapy. Patient-reported outcomes on therapy-specific side effects and symptom burden are evaluated to understand tolerability. The total participation duration varies based on treatment cycles and long-term follow-up assessments.