Sumrall, Mississippi
Improving CRT Outcome With Non-Invasive Cardiac Mapping
The study is conducted at European sites as a Post-Market Clinical Follow-Up study of a CE marked device (Amycard 01C). Its aim is to strengthen clinical evidence by assessing whether the use of this device for CRT planning improves clinical outcome in a statistically significant number of patients.
Phase
N/ASpan
132 weeksSponsor
EP Solutions SALisbon
Recruiting
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
The primary objectives of the study are Progression Free Survival (PFS) and Overall Survival (OS) as first line therapy in participants with programmed death-ligand 1 (PD-L1) TPS <50% and advanced or metastatic NSCLC without actionable genomic alternations. Eligible participants will be randomized in a 1:1:1 ratio to a) Dato-DXd plus pembrolizumab plus platinum; b) Dato-DXd plus pembrolizumab; or c) pembrolizumab plus pemetrexed plus platinum. Platinum therapy will be either carboplatin or cisplatin at investigator discretion. The study will be divided into three periods: Screening Period (including tissue screening), Treatment Period, and Follow-up Period.
Phase
3Span
238 weeksSponsor
Daiichi SankyoLisbon
Recruiting
Global Research Initiative for Patients Screening on MASH
GRIPonMASH is an observational study in which 10.000 high risk patients (type 2 diabetes mellitus, metabolic syndrome, obesity or arterial hypertension) in 10 different European countries will be screened for the presence of MASLD, liver fibrosis and (at-rsik) MASH using at least two non-invasive tests (FIB-4 and FibroScan). Additional published and exploratory non-invasive test will also be investigated. Blood samples and liver biopsy material will be collected. Genomic, proteomic, metabolomic, lipidomic and fluxomic studies will be applied to gain a better understanding of the pathophysiology of MASLD and to identify (bio)markers that will help to detect patients at-risk. The predictive value of FIB-4 in relation to FibroScan results and liver biopsy will be analysed. Long-term follow-up of 5 years in all participants will provide insight into the natural history of the disease.
Phase
N/ASpan
405 weeksSponsor
Julius ClinicalLisbon
Recruiting
A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
Phase
3Span
201 weeksSponsor
Idorsia Pharmaceuticals Ltd.Lisbon
Recruiting
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
Phase
3Span
575 weeksSponsor
Janssen Research & Development, LLCLisbon
Recruiting
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
Phase
3Span
217 weeksSponsor
Karuna TherapeuticsLisbon, Lisboa
Recruiting
Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure(PADN-CpcPH-PILOT)
Phase
N/ASpan
27 weeksSponsor
Pulnovo Medical (Wuxi) Co., Ltd.Lisbon
Recruiting
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
Phase
3Span
271 weeksSponsor
Bristol-Myers SquibbLisbon
Recruiting
Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
Approximately 200 subjects will be enrolled. Eligible subjects will be randomized in a 2:2:1 ratio to receive tinengotinib 8 mg QD, tinengotinib 10 mg QD or Physician's Choice in Part A; and eligible subjects will be randomized in a 2:1 ratio to receive the recommended Part B dose or selected dose or Physician's Choice in Part B.
Phase
3Span
141 weeksSponsor
TransThera Sciences (Nanjing), Inc.Lisbon
Recruiting
Critical Time Intervention-Peer Support
Critical Time Intervention-Peer Support is delivered by Community Mental Health Workers (CMHWs) and Peer Support Workers (PSWs). They will be selected, recruited, and trained by members of the research team to deliver mental health care according to the manualized recovery-oriented program. Ongoing regular supervision of PSWs and CMHWs, in weekly meetings, will be conducted throughout the study by members of the research team trained in CTI-PS by those who originally developed it at the Columbia University. Those allocated to the intervention group will receive usual care and, in addition, CTI-PS services over a 9-month period. The intervention has two broad objectives: 1) to collaborate with participants to develop durable connections to support systems, including both formal and informal supports (e.g., mental health services, primary care clinics, family, and friends); and 2) to provide practical and emotional support, helping the individual to overcome a critical period of transition during which they can feel especially vulnerable. The work of CTI-PS will focus on areas identified as crucial for strengthening the individual's continuum of services and forming enduring links with their community supports. The phases of CTI are Initiation, Try-Out, and Transfer of Care. The PSW-CMHW will collaborate with the participants to identify barriers to their recovery and develop a sustainable plan to engage in and use community supports and resources during and after CTI. They will also use their knowledge to increase participants' autonomy, strengthen their connection to health services, and expand their support networks. The role of CTI workers is specifically designed to avoid becoming the primary source of care for the individual.
Phase
N/ASpan
131 weeksSponsor
Lisbon Institute of Global Mental Health - LIGMHLisbon
Recruiting