Sant Cugat Del Valles

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating the safety and effectiveness of trontinemab in people with early symptomatic Alzheimer's disease, ranging from mild cognitive impairment to mild dementia caused by Alzheimer's. This Phase III study is designed to better understand how trontinemab affects cognitive decline in this population. Participants have confirmed Alzheimer's disease pathology and meet specific clinical criteria related to memory and cognitive function. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the active drug or placebo. Treatment will be given over a defined period, and participants will be monitored closely throughout. During the study, participants will undergo various assessments including MRI scans, clinical genotyping, and PET imaging or cerebrospinal fluid tests to confirm disease status. Cognitive tests such as the Mini-Mental State Examination (MMSE) and the Clinical Dementia Rating are used to track changes. Researchers will measure the change in Clinical Dementia Rating Sum of Boxes from baseline to week 72 to evaluate treatment effects. Safety and tolerability will also be monitored throughout the study duration.

This research aims to evaluate the safety and tolerability of a drug called ALN-5288, given directly into the spinal fluid, in adults diagnosed with Alzheimer's Disease. The study focuses on patients with mild cognitive impairment or dementia related to Alzheimer's, confirmed by specific brain imaging or fluid tests done within seven years before screening. It also investigates how the drug behaves in the body and its effects after dosing in a Phase 1 clinical trial setting. Participants will receive either ALN-5288 or a placebo, both administered intrathecally (into the spinal fluid). The study includes a double-blind period where neither participants nor researchers know who receives the drug or placebo, followed by an open-label extension phase where all participants may receive ALN-5288. This design helps assess safety and drug activity over time. During the study, participants will be closely monitored for adverse events, including their frequency and severity, for up to 32 months. Researchers will collect data on drug levels and effects, using clinical assessments and possibly biomarker evaluations. Safety evaluations will include brain and spinal procedures, vital signs, and laboratory tests. The total participation time spans the entire monitored period, ensuring ongoing safety and tolerability assessments.

Researchers are evaluating the efficacy, safety, and pharmacokinetics of intravenous prasinezumab compared with placebo in people with early-stage Parkinson's disease. Participants must be on stable symptomatic monotherapy with levodopa and meet specific criteria including body weight and disease stage. This Phase III study aims to understand how prasinezumab affects motor progression in Parkinson's disease. Participants will receive either prasinezumab or a placebo through intravenous infusion following a schedule outlined in the study protocol. The study compares these two groups to assess the impact of prasinezumab on disease progression. The treatments are administered regularly over the course of the trial. During the study, participants will be monitored for motor progression using the Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III score, with assessments continuing up to at least week 104. Researchers will also evaluate safety and pharmacokinetics throughout the trial. Participants are required to adhere to contraception requirements and attend scheduled visits for evaluations and infusions.

Researchers are investigating the effectiveness and safety of KarXT combined with KarX-EC in treating cognitive problems associated with mild to moderate Alzheimer's Disease. This phase 3 study focuses on patients diagnosed according to the National Institute on Aging and Alzheimer's Association criteria, targeting those with specific dementia stages and confirmed disease pathology. The goal is to assess whether this combination therapy can improve cognitive function in this population. Participants will receive either KarXT and KarX-EC together or a placebo, with doses given on specified days during the study. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active treatment or placebo during the trial. The treatment period lasts up to 24 weeks to evaluate the effects of these medications on cognitive impairment. During the study, participants will be closely monitored through cognitive assessments including the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 and the Clinician's Interview-Based Impression with caregiver input, both measured at 24 weeks. Caregivers play an important role by maintaining regular contact, reporting on the participant's condition, and helping with medication adherence. Safety and cognitive function will be regularly evaluated to understand the impact of the treatment over the study period.

Researchers are evaluating an investigational drug called marlotamig (REGN7075) alone and in combination with cemiplimab, with or without chemotherapy, in adults with advanced solid tumors. The study aims to assess the safety, tolerability, and optimal dosing of marlotamig with cemiplimab, as well as to explore their effectiveness in treating cancer by controlling tumor growth. Additional goals include monitoring side effects, studying how the drugs work in the body, measuring drug levels in the blood, and checking for the development of antibodies against the treatments that might affect their action or cause side effects. Participants may receive marlotamig through intravenous or subcutaneous injection weekly or every three weeks. Cemiplimab is given every three weeks by intravenous infusion or subcutaneous injection, sometimes combined with platinum-based doublet chemotherapy administered intravenously every three weeks. Other drugs like bevacizumab or trifluridine-tipiracil may also be given according to the study plan. Treatment and dosing schedules are carefully followed to find the best approach to manage advanced cancers. During the study, participants will be closely monitored for adverse effects including dose-limiting toxicities, treatment-emergent adverse events, serious events, and laboratory abnormalities for up to five years after the last dose. Researchers will also measure the objective response rate to evaluate how well tumors respond to treatment. Participants undergo regular assessments including biopsies, blood tests, and clinical evaluations to track safety and effectiveness throughout the study and follow-up periods.

Researchers are investigating whether using artificial intelligence (AI) to guide monitoring and timing of ovulation triggering in women undergoing ovarian stimulation for in vitro fertilization (IVF) can achieve clinical outcomes similar to those from traditional physician-led decisions. This study focuses on improving the number of mature eggs retrieved while managing clinic workload, especially by reducing weekend procedures, without compromising treatment success. AI is being explored as a tool to personalize treatment and optimize timing based on patient-specific responses, which can vary between cycles. The study compares two approaches: one where the physician makes ovulation trigger decisions based solely on clinical judgment and another where the physician uses recommendations from an AI software called STIMAI®. STIMAI® predicts the number of mature oocytes for different trigger days to assist the physician in deciding the best day for ovulation triggering. The physician retains final decision-making authority. Trigger timing is based on follicle size detected by ultrasound scans, with decisions made when 2-3 follicles reach 17 mm. Participants will be closely monitored with ultrasound scans at the study centers during their controlled ovarian stimulation cycles for IVF or fertility preservation. The primary outcome measured is the number of mature (MII) oocytes retrieved approximately 34-36 hours after ovulation trigger. The trial aims to assess if AI assistance can improve efficiency and outcomes without increasing clinical workload or compromising patient care. The study includes women aged 18 to 42 years undergoing ovarian stimulation with their own or donated eggs.

Researchers are evaluating two treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study focuses on comparing axillary radiotherapy (ART) without lymphadenectomy to axillary lymph node dissection (ALND) to see which approach lowers the risk of lymphedema while monitoring cancer recurrence and overall survival. The trial includes patients treated with either neoadjuvant chemotherapy or hormone therapy and aims to assess quality of life alongside clinical outcomes. This is a prospective, randomized, open-label, multicenter study involving about 820 patients divided evenly between chemotherapy and hormone therapy groups. Participants will receive either ART targeting axillary levels I and II plus level III, supraclavicular, and possibly the internal mammary chain, or undergo ALND followed by radiotherapy to level III, supraclavicular, and possibly the internal mammary chain. A pilot phase with the first 200 patients has been completed, and an interim analysis will be conducted on this group. During the study, researchers will track disease-free survival over up to five years from diagnosis, noting any recurrence or death. Patients will undergo imaging assessments such as ultrasound or MRI to evaluate axillary response after treatment. Quality of life and side effects like lymphedema will also be measured. Follow-up will include monitoring overall survival and recurrence, ensuring comprehensive evaluation of both treatment safety and effectiveness.

Researchers are comparing changes in soft tissue volume, including volume gain and stability, around dental implants using three different graft materials: sub-epithelial connective tissue graft (SCTG) from the palate, Porcine collagen matrix (CM), and Porcine Acellular dermal matrix (PADM). The study focuses on patients with soft tissue atrophy, mucogingival deformity on edentulous ridge, or edentulous alveolar ridge and evaluates outcomes at 3 and 15 months after implant placement. This is a Phase 4 randomized clinical trial assessing these graft materials' effects on tissue thickness and patient-reported outcomes. The treatments involve harvesting SCTG from the palate using a double-bladed knife to ensure consistent thickness, then trimming and securing the graft at the implant site with resorbable sutures. For the CM and PADM groups, the grafts are trimmed to the same size and placed similarly. Implant placement includes making a crestal incision, elevating a mucoperiosteal flap, preparing the receptor bed following a specific drilling protocol, placing a BioHorizons Tapered Pro Implant, and attaching a healing abutment. Participants will undergo assessments of soft tissue volume gain at 3 months as the primary outcome. The study includes monitoring volume changes and stability over time, and patient-reported outcome measures (PROMS) are collected to understand patient experiences. The study requires follow-up visits up to 15 months post-implant placement to evaluate long-term results and graft performance.