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This research aims to evaluate the effectiveness and duration of pain relief provided by a single infusion of 2R,6R-hydroxynorketamine compared with ketamine and saline in adults with chronic neuropathic pain of the extremities lasting longer than three months. The study is a randomized, double-blind, three-way crossover trial designed to compare these treatments on pain intensity, pain qualities, physical function, pain interference, sleep disturbance, and quality of life. Participants will receive each of the three study drugs2R,6R-hydroxynorketamine, ketamine, and salinein a random order, with each infusion given over 45 minutes and spaced five weeks apart, totaling a 15-week treatment period. The study uses a crossover design where participants experience all treatments in different sequences. Safety and efficacy are monitored throughout, with baseline and follow-up assessments including blood tests, ECGs, and physical exams. During the study, participants will undergo quantitative sensory and pain evaluations before the first treatment and on days 7, 14, 21, and 35 after each infusion. They will also complete patient-reported pain outcome questionnaires to assess changes in pain and related symptoms. Researchers will monitor safety, lab results, vital signs, and liver function throughout the trial. Participants are advised to continue their regular pain medications and use additional analgesics only as needed. The total study duration per participant is approximately 15 weeks of treatment plus assessment periods.

Researchers are investigating CGT9486, also known as bezuclastinib, in an open-label Phase 2 study for patients with Advanced Systemic Mastocytosis AdvSM. This includes those diagnosed with Aggressive Systemic Mastocytosis ASM, Systemic Mastocytosis with an Associated Hematologic Neoplasm SM-AHN, and Mast Cell Leukemia MCL. The study aims to evaluate the safety, effectiveness, pharmacokinetics, and pharmacodynamics of bezuclastinib in this patient population. Participants will receive bezuclastinib tablets orally, taken continuously in 28-day cycles. The study is divided into two parts Part I focuses on identifying effective and tolerable dosing exposures over 18 months, while Part II evaluates the drugs efficacy by measuring objective response rates and confirming the exposure-response relationship, also over 18 months. Additional assessments include effects on mutation allele burden, serum tryptase levels, histopathologic changes, spleen and liver volume, and safety monitoring. During the study, participants will undergo various clinical evaluations, including laboratory tests, imaging to monitor organ size changes, and assessments of disease response and progression. Researchers will track adverse events and pharmacokinetic profiles throughout the 18 months. The study involves continuous monitoring of participants to understand the treatments impact on survival and disease progression over this period.

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are evaluating the safety, tolerability, and early effects of 4D-710, an investigational gene therapy, in adults with cystic fibrosis CF lung disease who cannot use or tolerate existing CFTR modulator therapies. A sub-study also includes adults with advanced CF lung disease or frequent lung flare-ups who are currently on CFTR modulator therapy. This Phase 12 open-label trial aims to find appropriate dosing and assess potential benefits for these patient groups. Participants receive a single inhaled dose of 4D-710, which is a gene therapy designed to deliver a corrected version of the CFTR gene to lung cells. The study includes a dose exploration phase for those ineligible for modulator therapy, a dose expansion phase at selected doses, and a sub-study for participants on modulator therapy receiving various doses. Each participant undergoes one administration of the therapy during the trial. Throughout the study, participants are monitored for adverse events over a 60-month period. Evaluations include lung function tests, oxygen saturation measurements, and tracking of pulmonary exacerbations. Participants maintain their existing treatments if applicable, and researchers assess safety and early signs of effectiveness. The total study duration extends up to approximately nine years, including long-term observation after dosing.

Researchers are evaluating the use of XYOSTED as a testosterone replacement therapy in adolescent males aged 12 to under 18 years with primary or secondary hypogonadism, a condition where the body produces little or no testosterone. This Phase 34 open-label study aims to assess how well XYOSTED supports the continuation or start of puberty, along with its safety and the testosterone levels it maintains. Participants will receive XYOSTED injections at doses tailored to their weight and targeted pubertal stage. Dose adjustments will be made based on testosterone levels measured at specific intervals after dosing, with evaluations approximately every three months to reach the desired hormone levels. After completing the 52-week initial study period, participants may enter a 24-month extension to further monitor long-term safety and treatment effects. Throughout the study and extension, participants will undergo clinical examinations including pubertal staging, blood tests for testosterone and other labs, bone density scans, body composition assessments, and X-rays to monitor bone age. Researchers will track changes in puberty progression, bone health, body measurements, and hormone levels. Participants will attend regular clinic visits every six months during the extension phase to continue safety and pharmacokinetic evaluations.

Researchers are evaluating the long-term safety and tolerability of LB-102 in adults with stable schizophrenia who have had inadequate responses, side effects, or issues with their current antipsychotic medications, or who have completed prior LB-102 studies. This Phase 3, open-label, multicenter trial focuses on patients aged 18 to 65 years with stable disease and aims to provide extended monitoring of this treatment. Participants will receive LB-102 with flexible dosing ranging from 50 mg to 100 mg. This single-group study involves administering the drug openly over 52 weeks to assess how well patients tolerate it and to monitor safety during this period. Throughout the study, participants will undergo evaluations including monitoring adverse events and treatment-emergent events. Effectiveness will be assessed using the Positive and Negative Syndrome Scale PANSS. The study lasts up to 52 weeks, during which safety and tolerability are carefully observed and recorded.

The trial investigates the biomechanical effects of the Ossur Power Knee, a microprocessor-controlled prosthetic knee with active motor-driven flexion and extension, compared to the Ossur Rheo XC, a passive microprocessor-controlled knee. The study focuses on unilateral transfemoral amputees aged 45 to 75 years, aiming to evaluate differences in walking and mobility, including a comparison by gender to identify any sex-specific prosthesis needs. The research is designed to improve understanding of prosthetic knee function and enhance prosthesis selection for users. Participants will be fitted with both the Ossur Power Knee and the Ossur Rheo XC in a crossover design, receiving one month of accommodation with each device before evaluation. The Power Knee provides powered knee flexion and extension, while the Rheo XC modulates damping passively during movement. Subjects will perform walking, stair climbing, slope navigation, and sit-to-stand activities while wearing each knee. Questionnaires and at-home diaries will capture user perceptions of comfort, exertion, and stability. During the study, detailed biomechanical data such as walking speed, metabolic energy cost, symmetry during sit-to-stand movements, step length, toe clearance, leg loading, and pelvic motion will be collected. Assessments occur after each one-month accommodation period. The study uses motion analysis labs for gait data and includes participant self-reporting. The total participation timeline includes fitting, training, accommodation, and evaluation phases for both knee types, allowing each participant to serve as their own control.

Researchers are investigating whether touch sensation can be restored to the breast after mastectomy using neural stimulation. This trial aims to gather information to guide future studies on the safety, effectiveness, and acceptability of this approach. The study focuses on women undergoing bilateral mastectomy with two-stage reconstruction for certain types of breast cancer or breast cancer risk reduction. Participants will receive a small medical device called the Bionic Breast implant, temporarily placed in one breast during the mastectomy. This device sends tiny electrical currents to nerves to create sensory stimulation in response to touch or pressure. The device will later be removed, and the study will assess the sensations produced by the stimulation. During the study, participants will complete psychophysical tasks seven months after mastectomy, implantation, and device removal to evaluate sensation and stimulation levels. Researchers will measure outcomes such as stimulation intensity, ability to distinguish different stimuli, and mapping of sensation areas. Participants will be monitored throughout for safety and adherence, with the total study duration spanning several months post-surgery.

Researchers are evaluating the safety and efficacy of the study drug LY4065967 for treating diabetic peripheral neuropathic pain DPNP. This trial is part of a larger chronic pain master protocol designed to accelerate the development of new treatments for chronic pain conditions. The study focuses on adults with DPNP related to type 1 or type 2 diabetes. Participants will be randomly assigned to receive either LY4065967 or a placebo, both taken orally. The study is double-blinded, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts eight weeks, during which participants take the assigned study drug daily. Throughout the trial, participants will report their pain intensity and other symptoms at the start and after eight weeks using various scales, including the Numeric Rating Scale and Brief Pain Inventory. Researchers will also monitor sleep quality, emotional functioning, and the use of rescue medication. Safety and tolerability will be assessed, and the study concludes in July 2027.

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.