Parla

Researchers are conducting a global study to understand the impact of moderate to severe alopecia areata (AA), non-segmental vitiligo (NSV), and hidradenitis suppurativa (HS) on adolescents and adults. This study aims to assess the burden these conditions place on patients' quality of life and daily functioning in a large real-world population. The study involves participants diagnosed by a physician with one of the three conditions: AA, NSV, or HS. There are no interventional treatments or medications being tested in this study, as it is observational in nature. Data collection focuses on patient-reported outcomes and measures that evaluate disease severity and its effects. Participants will complete various questionnaires and assessments related to their condition, such as the Alopecia Areata Symptom Impact Scale (AASIS) for AA, the Severity of Alopecia Tool (SALT) for scalp hair loss in AA, the Facial Vitiligo Area Scoring Index (F-VASI) and Vitiligo Quality of Life Score (VitiQoL) for vitiligo, and the Dermatology Life Quality Index (DLQI) and International Hidradenitis Suppurativa Severity Scoring System (IHS4) for HS. These tools help researchers understand how symptoms affect quality of life and disease severity. The study collects information up to the day of the study visit.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

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 evaluating the effectiveness and safety of subcutaneous immunotherapy for people aged 12 to 65 who have mild to moderate allergic rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma. Participants are sensitized to grass and olive pollen, and the study is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. The study aims to measure combined symptoms and medication scores over 12 months to assess treatment impact. The study includes three groups receiving different treatments: two doses of purified and polymerized allergen extracts from a mixture of grasses and olive pollen (10,000 MG01 + 10,000 T517 and 30,000 MG01 + 10,000 T517) and a placebo group receiving a similar solution without active ingredients. Treatments are administered subcutaneously over one year. The study is double-blinded and controlled to compare safety and efficacy across groups. Participants will be involved for one year, during which they will record their symptoms and medication use via a smartphone app. Researchers will conduct clinical evaluations, skin tests, and measure specific IgE levels to monitor allergic responses. The main outcome is the Combined Symptoms and Medication Score (CSMS) after 12 months. Safety and treatment adherence will be closely monitored throughout the study period.

Researchers are studying patients diagnosed with cancer who experience a venous or arterial thromboembolic event, either symptomatic or found incidentally. These events may occur within a month before the cancer diagnosis or at any time after it. This observational, epidemiological, multicenter study aims to gather detailed data about these thromboembolic episodes in cancer patients. The study does not involve any interventions or treatments but collects information about the thromboembolic event, including its location, vessel of origin, diagnosis type, and characteristics of cancer at the time of the event. It also records the timing between cancer diagnosis and the thromboembolism. Participants are observed over time, with data collected at baseline and a 12-month follow-up visit to assess patient status and treatment details. Participants provide consent and undergo imaging confirmation of thromboembolic events using techniques like Doppler echocardiography or CT angiography. Researchers track multiple outcome measures such as tumor classification, primary tumor presence, and treatment administered for cancer. The study monitors participants for a year to record their clinical situation and gather comprehensive information on cancer-associated thrombosis.

Researchers are evaluating the safety of medications used to treat inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, in pregnant women and their children. This observational registry study in Spain will follow pregnant women with IBD over five years and track their children for four years to assess the risk of serious infections, developmental issues, and other serious adverse events. The study aims to clarify the impact of these medications on pregnancy outcomes and child health, especially focusing on serious infections in children, a topic with previously conflicting results. Pregnant women with IBD will be enrolled before the 28th week of gestation and grouped based on their exposure to biologic drugs, immunomodulators, or neither during pregnancy and the three months before conception. Researchers will collect detailed information at multiple points during pregnancy and up to four years after birth. Mothers will be contacted regularly to update data on disease activity, treatment, and any serious adverse events. Children will undergo developmental assessments using questionnaires completed by their mothers at specified intervals throughout the follow-up period. Participants will have scheduled visits at baseline, each trimester, one month after delivery, and quarterly during the child's first four years. Data collected include clinical status of the mother, pregnancy complications, birth details, child development, vaccinations, infections, hospitalizations, and serious adverse events. The study will monitor outcomes such as serious infections and adverse events in both mothers and children, with data securely managed using a web-based electronic system. This long-term follow-up aims to provide comprehensive safety information on IBD treatments during pregnancy and breastfeeding.

This observational, multicenter study focuses on patients diagnosed with lung cancer and other thoracic tumors. It aims to improve treatment and prognosis by exploring patient data related to the expression of markers that predict responses to chemotherapy and molecular inhibitors. The study reflects a commitment to individualized treatment and understanding the epidemiology of thoracic tumors in Spain, addressing the high mortality and variability in diagnosis and treatment. The study collects information both retrospectively and prospectively from clinical histories of patients treated by thoracic surgeons and medical oncologists. It investigates epidemiological and therapeutic factors associated with thoracic tumors, including lung cancer, to support strategies like multidisciplinary care and early diagnosis. There are no interventions or treatments assigned, as this is an observational registry gathering comprehensive real-world data. Participants will have their clinical data reviewed to describe characteristics of lung cancer and other thoracic tumors over up to 10 years. The study aims to explore the epidemiology and treatment approaches, supporting future improvements in care. There is no age or gender restriction, and data collection includes both patients receiving active treatment and those under palliative care. The study duration, follow-up, and specific assessments are based on patient records and available medical information.