Parla

Researchers are studying the impact and burden of three skin conditions moderate or severe alopecia areata, non-segmental vitiligo, and moderate to severe hidradenitis suppurativa. The study includes adolescents and adults and aims to understand how these conditions affect quality of life and daily functioning in a large global population. This is an observational study where participants with each condition will have a single visit for data collection following routine clinical practice. No experimental treatments are given instead, the study gathers information during this one visit to assess disease characteristics and impact. During the visit, participants will complete questionnaires and clinical assessments specific to their condition. These include tools measuring symptom impact, hair loss severity, skin depigmentation, and quality of life related to each disease. This helps researchers better understand the real-world burden of these conditions. Participation involves only this one visit, with no long-term follow-up or additional procedures.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

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 evaluating the effectiveness and safety of subcutaneous immunotherapy in patients aged 12 to 65 who have mild to moderate rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, caused by sensitivity to grass and olive pollen. This randomized, double-blind, placebo-controlled phase 3 trial aims to study allergy treatments to improve symptoms and reduce medication use over one year. Participants are randomly assigned to one of three groups one receiving 10,000 TUmL MG01 plus 10,000 TUmL T517, another receiving 30,000 TUmL MG01 plus 10,000 TUmL T517, and a placebo group receiving the same solution without active ingredients. The allergen extracts come from a mixture of grasses and olive pollen, administered through subcutaneous injections. Treatment lasts for one year, evaluating different doses compared to placebo. During the study, participants will regularly record symptoms and medication use using a smartphone app. Researchers will monitor combined symptoms and medication scores as the primary outcome, along with medication-free days, symptom-free days, asthma exacerbations, quality of life tests for rhinitis and asthma, and immune response measures. Safety is closely followed through adverse reaction monitoring and immunological and security parameters over the 12-month treatment period.

Researchers are conducting an observational, epidemiological study to understand thrombosis in patients diagnosed with cancer. This study focuses on patients who experience venous or arterial thromboembolic events, either symptomatic or incidental, occurring within a month before cancer diagnosis or any time afterward. The study collects detailed information about the characteristics and timing of these events in relation to cancer diagnosis to better understand this condition. The study does not involve any interventions or treatments, as it is non-interventional and observational. Data is gathered from multiple centers, tracking details such as the location and vessel of origin of the thromboembolic event, tumor characteristics, and treatment administered for cancer at baseline. Patients are followed up for 12 months to assess their situation and outcomes related to thrombosis and cancer. Participants are involved through data collection at baseline and follow-up visits. Researchers assess imaging-confirmed thromboembolic events using techniques like Doppler echocardiography and CT angiography. The study measures various outcomes including event diagnosis, tumor stage, timing between cancer diagnosis and thrombosis, and patient status at one year. This registry provides valuable information about cancer-associated thrombosis over time.

This research aims to understand the safety of drugs used to treat inflammatory bowel diseases IBD during pregnancy and breastfeeding, focusing on outcomes for both mothers and their children. The study is observational and will follow pregnant women diagnosed with IBD Crohns disease, ulcerative colitis, or unclassified IBD over five years in Spain. It will also track the health and development of their children for up to four years, particularly looking at serious infections and other serious adverse events. Participants are grouped based on their exposure to IBD medications during pregnancy or shortly before conception those treated with biologic drugs, those treated with immunomodulators, and those not exposed to these drugs. Data will be collected at multiple points during pregnancy and after birth, including disease activity and serious adverse events for the mother, and development, infections, and other health events for the children. The study uses questionnaires and regular follow-ups every three months for children until age four. During the study, mothers will provide information through in-person visits and remote contacts, including completing developmental questionnaires for their children yearly. Researchers will gather detailed clinical data at baseline and during each trimester, delivery, and postpartum. The main outcomes measured include rates of serious infections and adverse events during pregnancy and in children up to four years old. The study also assesses developmental status and the risk of malformations or neoplasms in children related to exposure to IBD drugs.

This research aims to collect detailed information about patients with lung cancer and other thoracic tumors to better understand the disease and treatment outcomes. It focuses on individualizing treatment based on markers that predict response to chemotherapy and molecular inhibitors. The study addresses challenges such as poor prognosis, variability in diagnosis and treatment, and the need for improved early detection and prevention strategies across Europe and Spain. The study is observational and multicenter, gathering data both retrospectively and prospectively from patients diagnosed and treated by medical professionals including thoracic surgeons and oncologists. It includes multiple groups of patients based on the type of thoracic tumor, such as non-small cell lung cancer, small cell lung cancer, mesothelioma, thymic cancer, and carcinoid cancer. There are no experimental treatments instead, it involves comprehensive data collection on patient characteristics and treatments. Participants provide information from their medical history and treatment records over up to 10 years. Researchers study epidemiological and therapeutic factors related to thoracic tumors by reviewing clinical data. The main outcome is to describe characteristics of these tumors in Spanish patients. The study involves no interventions or medications, focusing on observation and data analysis to inform future care and research.