Sant Cugat Del Valles

Researchers are evaluating the long-term safety and tolerability of JNJ-81201887, given as an intravitreal injection a shot into the eye, in participants with Geographic Atrophy GA secondary to Age-related Macular Degeneration AMD. This study is a long-term extension of parent clinical trials where participants had previously received either low or high doses of JNJ-81201887 or a sham procedure. The goal is to monitor participants over an extended period to understand any lasting treatment effects or side effects. Participants entering this long-term extension study will not receive additional doses of the study drug or any new intervention as part of this trial. They previously participated in parent studies where they were treated with either low dose or high dose JNJ-81201887 or sham procedure. Some participants who were in the sham group of the parent study may receive open-label treatment outside this study before entering this extension. This study focuses solely on follow-up without new treatment administration. Throughout the study, participants will undergo regular assessments to monitor ocular and systemic safety. These include tracking treatment-emergent adverse events, clinical laboratory tests, retinal imaging, and eye examinations over up to five years. This extended monitoring aims to evaluate the long-term safety profile of the previous treatments. Participants will be followed with periodic visits and evaluations, with the total study duration extending until 2030.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III study aims to better understand the impact of trontinemab on cognitive decline and daily functioning in this population. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants will be assigned to receive either intravenous trontinemab or an intravenous placebo. The treatment period lasts up to 72 weeks, during which participants receive infusions as scheduled. Assessments include brain imaging such as amyloid and tau PET scans, cerebrospinal fluid and blood biomarker collection, and cognitive testing. The study also monitors safety through tracking adverse events, infusion-related reactions, and anti-drug antibodies. Participants will attend visits for evaluations including clinical dementia rating, cognitive scales like MMSE and ADAS-Cog-13, and daily living activities assessments. Safety monitoring involves MRI scans and lab tests. The primary outcome measured is the change in Clinical Dementia Rating, Sum of Boxes CDR-SB, from baseline to Week 72. The total duration of participation extends through the 72-week treatment and assessment period, with ongoing safety evaluations.

Researchers are evaluating the safety, tolerability, pharmacodynamic, and pharmacokinetic effects of an investigational drug called ALN-5288, administered intrathecally, in adults with Alzheimers Disease. The study focuses on adults aged 40 to 80 who have mild cognitive impairment or dementia due to Alzheimers, confirmed by clinical findings and specific biomarker tests. This is a phase 1, randomized, placebo-controlled study with a double-blind period followed by an open-label extension. Participants will be randomly assigned to receive either ALN-5288 or a placebo during the double-blind period. After this, all participants will receive ALN-5288 during the open-label extension phase. Both ALN-5288 and placebo are given through intrathecal administration. The study is designed to assess how the drug behaves in the body and its effects over time. During the study, participants will be monitored for adverse events, and various samples will be collected to measure levels of ALN-5288 and related proteins in cerebrospinal fluid, plasma, and urine. The study will last up to 32 months, with ongoing safety and pharmacokinetic assessments. This long-term monitoring includes evaluating cognitive status and ensuring participant safety throughout the trial.

Researchers are evaluating the efficacy, safety, and how the body processes pharmacokinetics prasinezumab compared with a placebo in people with early-stage Parkinsons disease PD who are on stable levodopa monotherapy. This Phase III study aims to understand if prasinezumab can affect the progression of motor symptoms in this population. Participants will receive either prasinezumab or a placebo as an intravenous IV infusion during the double-blind treatment period. After completing this phase, eligible participants may enter an open-label extension where they can receive prasinezumab. Infusions are given according to a schedule detailed in the study protocol. Throughout the study, participants will be regularly assessed using the Movement Disorder Society - Unified Parkinsons Disease Rating Scale MDS-UPDRS Part III to monitor motor progression, along with other clinical measures and safety evaluations. Researchers will also track adverse events, antibody development against the drug, and drug levels in the blood. The study includes monitoring up to at least 104 weeks, with safety follow-up extending 70 days after the final dose.

Researchers are studying the effects of KarXT combined with KarX-EC to treat cognitive impairment in people with mild to moderate Alzheimers Disease. This Phase 3 clinical trial aims to evaluate both the efficacy and safety of this treatment compared to a placebo, focusing on improving cognitive function and daily living activities over 24 weeks. Participants will be randomly assigned to receive either the active drugs KarXT and KarX-EC or a placebo, following specified dosing schedules. The study uses a double-blind, parallel-group design, meaning neither the participants nor the researchers know who receives the active treatment or placebo during the trial period. Participants will be monitored through various assessments including cognitive scales like the Alzheimers Disease Assessment Scale-Cognitive Subscale 11 ADAS-Cog11 and clinician interviews at baseline and week 24. Safety will be closely observed via monitoring adverse events, vital signs, laboratory tests, and heart function tests. The total duration of participation includes treatment and follow-up until study completion.

Researchers are evaluating the safety, tolerability, immune response, and how the body processes and responds to the drug RO7812653 in people with early symptomatic Alzheimers Disease eAD. This Phase I trial compares RO7812653 to a placebo to understand its effects when given via spinal injection. The study is designed as a randomized, double-blind, placebo-controlled trial involving participants aged 50 to 75 years with early Alzheimers symptoms. Participants will be randomly assigned to receive either a single dose of RO7812653 or a placebo through intrathecal administration. The dosing follows a schedule outlined in the study protocol and is part of a parallel group design. The trial includes monitoring for drug presence in blood plasma and cerebrospinal fluid, as well as checking for antibodies against the drug. During the study, participants will undergo assessments to monitor safety, including tracking any adverse events and changes in suicide risk over about 40 weeks. Evaluations also include neuropsychological testing, imaging to assess brain conditions, and laboratory tests. Participants are expected to complete all assessments with or without the help of a study partner, and the study aims to gather detailed information on the drugs effects and safety over the study period.

Researchers are investigating whether using artificial intelligence AI to guide monitoring and timing of ovulation trigger in women undergoing ovarian stimulation for in vitro fertilization IVF can achieve clinical outcomes similar to traditional physician-led decisions. This trial aims to compare AI-assisted decision-making with routine clinical management to optimize the number of eggs retrieved, improve workflow efficiency, and reduce clinical workload, especially weekend procedures. Participants will be randomly assigned to one of two groups one where trigger decisions are made by the physician assisted by the AI software called STIMAI, and the other where trigger timing is determined by the physician alone based on clinical judgement. The AI software analyzes patient data to predict the optimal trigger day, offering options for triggering today or tomorrow, while the physician makes the final decision. The study focuses on individualized treatment to improve outcomes and scheduling. During the study, participants will undergo controlled ovarian stimulation with regular monitoring including ultrasounds. Researchers will measure the number of mature eggs retrieved about 34-36 hours after ovulation trigger, as well as other outcomes like follicle counts, length of stimulation, and number of clinic visits. The trial also tracks spontaneous ovulation and the distribution of retrieval procedures throughout the week. Participation will last through the stimulation cycle until egg retrieval, with assessments of both clinical results and process efficiency.

Researchers are evaluating two different treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study aims to compare axillary radiotherapy ART with axillary lymph node dissection ALND to see which approach results in less risk of lymphedema and how each affects recurrence and overall survival. This trial is a prospective, randomized, open-label, parallel-assigned, multicenter study involving 820 patients over 5 years, including those treated with chemotherapy and hormone therapy. Participants are randomly assigned to one of two groups. One group receives axillary radiotherapy targeting levels I and II plus level III and supraclavicular areas, with or without the internal mammary chain, but without lymphadenectomy. The other group undergoes axillary lymph node dissection along with radiotherapy to level III and supraclavicular areas, with or without the internal mammary chain. The study includes a pilot phase with the first 200 patients and plans interim analysis to assess progress. During the trial, participants will be monitored for disease-free survival, overall survival, and the incidence of lymphedema for up to 5 years, with lymphedema tracked for up to 3 years after surgery. Researchers will evaluate outcomes related to recurrence and quality of life. The study involves regular assessments including imaging to evaluate axillary response and follow-up visits to monitor health and side effects. Participants are followed closely to understand the long-term impact of the treatments.

Researchers are comparing changes in soft tissue volume and patient-reported outcomes around dental implants using three different graft materials a sub-epithelial connective tissue graft SCTG from the palate, porcine collagen matrix CM, and porcine acellular dermal matrix PADM. This phase 4 randomized clinical trial aims to evaluate volume gain and stability at 3 and 15 months after implant placement. The study involves four groups one receiving implant placement and prosthetic tooth rehabilitation alone, and three groups receiving implant placement plus soft tissue augmentation with either SCTG, CM, or PADM at the implant site, followed by prosthetic rehabilitation. SCTG grafts are harvested from the palate and trimmed to specific dimensions, while CM and PADM grafts are similarly trimmed and secured at the recipient site. Implant placement includes making a crestal incision and preparing the bone to place a tapered implant with a healing abutment. Participants will undergo assessments including soft tissue volume gain at 3 months and volume stability at 15 months. Additional measures include plaque index, bleeding on probing, probing depth, keratinized tissue width, phenotype evaluation at baseline, 12 weeks, and 15 months, as well as patient-reported outcomes shortly after surgery. Pink Esthetic Score will be evaluated around 16 months after crown placement. Safety and progress will be monitored throughout the study with a total participation period extending beyond 15 months.