Kumamoto Prefecture, Japan

Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia

Critical lower Limb Threatening Ischemia is the most advanced stage of lower limb arterial disease and is associated with a high risk of mortality and major amputation.Literature data indicate that about 5-10% of patients with peripheral arterial disease have a risk of developing CLTI, therefore the most advanced stage of arterial disease of the lower limbs, within 5 years and have a mortality of 20% at 6 months after diagnosis of CLTI.Despite the continuous improvement of the techniques and materials used in the revascularization of these patients, the data of the Literature show that in about 10-15% of these patients revascularization is impossible or ineffective. This condition is defined as: "no-option" CLTI.Therefore, for patients with "no-option" CLTI an alternative treatment for limb rescue may be considered the use of arterialization of the venous plexus of the foot; that is, to use to bring the arterial flow to the foot a healthy conduit, such as the vein, instead of the diseased artery and no longer usable. The present study is designed as a multicentre, prospective, single-arm, observational study. All eligible subjects for undergoing PiPER procedure at sites participating in the study will be considered for enrolment and will be asked to give consent prior to participating. Subjects will be considered enrolled in the study at the time written informed consent is given to the use of their personal data. Once patients are enrolled, their demographics, medical history, disease-relevant conditions, treatment details and outcomes will be collected for up to 24 months from the procedure. The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done. The revascularization procedure will be performed as per the current clinical practice. After discharge all patients will attend clinic visits at 30 days (±7 days), 6 months (±14 days),12 months (±30 days), 24 months (±30 days).

A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis

Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma

This is a multicentre, prospective and non-interventional study in which all patients treated according to clinical practice will be included. The registry will include all patients with metastatic urothelial carcinoma or with lymph node involvement defined as unsuitable for surgery. The study involves medical visits and clinical-radiological re-evaluations according to clinical practice. There are no additional procedures. The clinician will establish the number of visits necessary for each patient according to the needs encountered and depending on the treatment chosen. The participating centers were selected in such a way as to adequately represent all the different geographical areas. The duration of the study is 24 months: 12 months of enrollment plus 12 months of further follow-up.

The Unmet Needs of Cancer Survivors in Ausl IRCCS Reggio Emilia

The escalating global population of cancer survivors (CSs) underscores the imperative to offer services tailored to address their specific unmet needs. Individuals are designated as 'cancer survivors' from the moment of diagnosis onward throughout their lifetime. Despite this, there is a worldwide acknowledgment that CSs encounter a spectrum of physical, psychosocial, spiritual, informational, and practical challenges, often leading to unmet needs that frequently go unrecognized and unaddressed. Unmet needs, in this context, refer to those requirements perceived by individuals as lacking the necessary level of service for achieving optimal well-being. These can be characterized as unsatisfied needs for which CSs desire additional assistance or support. A profound comprehension and measurement of CSs' unmet needs play a pivotal role in identifying gaps in their care experiences, providing an opportunity to deliver patient-centered services. Effective care delivery not only enhances patient outcomes and quality of life but also contributes to increased satisfaction with care. This, in turn, may lead to a reduced demand for health and social care services. The qualitative study outlined here seeks to delve into the unmet needs of individuals who have undergone a cancer diagnosis within the past years and have completed the acute phase of treatment. The study aims to leverage the experiences of patients, caregivers, and stakeholders to optimize cancer survivorship care. Specifically, the investigation will focus on the unmet needs of cancer survivors post the acute treatment phase for some of the most prevalent forms of cancer with a life expectancy of at least five years. Namely: 1. To investigate the unmet needs perceived by cancer survivors in AUSL IRCCS Reggio Emilia setting. 2. To determine the area of impact on health encompassed by those unmet needs to create a direct link to the ICF. 3. To determine which Patient Reported Outcome Measure aimed at identifying cancer survivors' unmet needs will best investigate those ICF components connected to common cancer survivors' unmet needs to implement it in their routine assessment. 4. To identify the services that need to be implemented to provide support to the true needs of local cancer survivors. 5. To develop a Survivorship care plan model coherent with patients' expectations and health care system economic resources. Utilizing focus groups and interviews, the research will recruit participants from the AUSL - IRCCS Reggio Emilia district who have completed treatment for breast, prostate, colorectal, thyroid, and multiple myeloma cancers. The study will adhere to a structured schedule for conducting focus groups and interviews, accommodating participants in individual interviews if logistical or personal challenges arise. Each focus group, homogeneous in terms of pathology, will include 4 to 8 participants, with a total ranging between 30 and 60 participants based on Krueger's recommendations. Audio recording and verbatim transcription of focus groups and interviews will facilitate subsequent framework and thematic analysis to extract meaningful insights. The study's objectives encompass investigating perceived unmet needs, determining the health impact linked to these needs within the International Classification of Functioning, Disability, and Health (ICF), identifying suitable Patient Reported Outcome Measures, pinpointing services for implementation, and developing a Survivorship care plan model aligning with patient expectations and healthcare system resources. The focus groups and interviews, including patients with or without linked caregivers, will be systematically transcribed and analyzed using framework and thematic analysis methodologies.

Rehabilitation Intervention to Prevent Adverse Events Related to Androgen-deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer (PCa): a Single Arm Feasibility Study (ReCaP Study)

A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

Acquired from Horizon in 2024.

Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC).

The CARRY-ON study is a multicenter, prospective, open-label single-arm phase II trial, designed to seek for a signal of efficacy of continuing PD-L1 inhibition in patients with sensitive relapse ES-SCLC by adding atezolizumab to rechallenge carboplatin-etoposide chemotherapy. The trial is planned to enroll 142 patients with sensitive relapse ES-SCLC from 25 Italian centers. Sensitive relapse is defined as SCLC relapsed or progressed to first-line chemo-immunotherapy with PD-L1 inhibition (with either atezolizumab or durvalumab) at least 60 days after the last chemotherapy administration. Eligible patients will receive re-challenge chemotherapy (either carboplatin AUC 4 on day 1 plus etoposide 80 mg/m2 days 1-3 or carboplatin AUC 5 on day 1 plus etoposide 100 mg/m2 days 1-3, at investigator's choice) plus atezolizumab 1200 mg flat dosing on day 1 every 3 weeks until PD, unacceptable toxicity or to a maximum of 4 cycles (induction phase) followed by atezolizumab 1200 mg flat dosing every 3 weeks (maintenance phase) until completion of 1 year of maintenance (up to 18 cycles), progressive disease, unacceptable toxicity, patient refusal or loss of clinical benefit (investigator's choice), whichever occur first. Subjects will attend clinical visits at regular intervals to receive trial treatment and for efficacy and safety assessments. All subjects will be monitored continuously for any AE while on study treatment. Radiological assessment will be performed by computed tomography (CT) scan at week 6 (± 7 days), at week 12 (± 7 days) and every 12 weeks (± 7 days) thereafter. The duration of the study is expected to be a maximum of 45 months. The study recruitment period is expected to be approximately 24 months, maximum treatment duration will be 15 months (3 months of induction and 12 months of maintenance), and subsequent survival follow-up will be a maximum of 6 months.

A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis

Phase 2 Study Applying MRD Techniques for Participants With Previously Untreated Multiple Myeloma Treated With D-VRd Prior To and After High-dose Therapy Followed by ASCT - TAURUS