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NCT ID: NCT05622136 Recruiting - Clinical trials for Hepatocellular Carcinoma

Dose-escalation of Regorafenib in Advanced Hepatocellular Carcinoma

STRAT-aHCC
Start date: September 10, 2023
Phase: Phase 2
Study type: Interventional

The present protocol (STRAT-aHCC trial) aims to prospectively evaluate the tolerability, quality of life and efficacy of an alternative regimen of regorafenib in patients with advanced hepatocellular carcinoma (HCC) after progression to first-line. Patients will receive increasing dose of regorafenib in the first 2 treatment cycles (initial dose of 80mg, with weekly increments of 40mg up to 160mg in the first 2 treatment cycles). From the 3rd cycle on, the maximum tolerated dose during the first 2 cycles will be maintained. The maximum tolerated dose will be considered the highest dose in which the patient does not present grade ≥3 adverse events. The primary endpoint is the proportion of evaluable patients completing cycle 4. Radiologic response rate, quality of life, time to progression and overall survival will be evaluated as secondary endpoints.

NCT ID: NCT05620407 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

POETYK SLE-2
Start date: January 12, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

NCT ID: NCT05617677 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

POETYK SLE-1
Start date: January 12, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

NCT ID: NCT05617638 Recruiting - Pain Clinical Trials

Impact of Virtual Reality (e-Nature VR) During Hospitalization in Adult Intensive Care Unit

Start date: June 27, 2023
Phase: N/A
Study type: Interventional

Randomized clinical trial to analyze the perceived impact of the virtual reality intervention on the experience of pain and well-being, and the influence on vital signs and the relationship with the length of stay in the intensive care unit.

NCT ID: NCT05611801 Recruiting - Hemophilia A Clinical Trials

A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B

BASIS KIDS
Start date: December 9, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called marstacimab) for the potential treatment of hemophilia in pediatric patients. This study will enroll pediatric participants from ages 1 to 17 years in a sequential manner. The study will open enrollment to adolescent participants aged 12 to 17 years first. Then children aged 6 to 11 years will be permitted to enroll. Lastly, children aged 1 to 5 years will be permitted to enroll. This study will enroll participants who: - have severe Hemophilia A or moderately severe to severe Hemophilia B (with or without inhibitors) - have accurate historical records documenting all factor VIII, factor IX, or bypass agent infusions and hemophilia bleed events for at least 1 year prior to entering the study - if a non-inhibitor patient, must be on a stable routine prophylaxis regimen with factor VIII or factor IX replacement products for at least 12 months prior to study entry - if an inhibitor patient, must be on an on-demand bypass treatment regimen during the 12 months prior to study entry All participants in this study will receive marstacimab to use prophylactically. Marstacimab will be given once a week as a subcutaneous (under the skin) shot. The first dose of marstacimab will be given at the study site by the study site staff. During the 12-month treatment period, weekly doses of marstacimab can be given at home, or if preferred, the doses may be given by the study site staff. To help us determine if the study medicine is safe and effective, we will compare participant experiences when they are taking the study medicine to a historical period when they were not. Researchers want to see if the study medicine works to prevent the bleeding episodes commonly experienced by patients with Hemophilia. Participants will be in this study for about 14 months (approximately 1 month in a Screening period, 12 months receiving treatment, and 1 month in a follow-up period) during which they will visit the study site at least 10 times. If preferred, and if local regulations allow it, 2 of the study visits can be completed at the participant's home instead of at the study site. There will also be 6 scheduled telephone calls approximately every 2 months.

NCT ID: NCT05611268 Recruiting - Clinical trials for Eisenmenger Syndrome

Pentoxifylline as an Adjunct Therapy for Patients With Eisenmenger Syndrome

Start date: June 3, 2022
Phase: N/A
Study type: Interventional

The Eisenmenger syndrome corresponds to the most advanced form of pulmonary arterial hypertension associated with congenital heart disease. The syndrome causes chronic hypoxemia, with an increase in erythrocyte mass, which predisposes to thrombotic complications. Pentoxifylline is a xanthine derivative and it is considered as a hemorrheological agent with described effects of reduction in erythrocyte and platelet aggregation, adhesion and activation of leukocytes, and endothelial damage. The main objective of this study is to verify if the chronic oral administration of pentoxifylline to Eisenmenger patients induces an increase in the circulating levels of thrombomodulin, a naturally occurring proteoglycan with anticoagulant, anti thrombotic and anti-inflammatory properties.

NCT ID: NCT05609968 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)

Start date: February 6, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).

NCT ID: NCT05609630 Recruiting - Clinical trials for Juvenile Idiopathic Arthritis

Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis.

SELECT-sJIA
Start date: October 2, 2023
Phase: Phase 3
Study type: Interventional

Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis that affects children. The term "idiopathic" means "of unknown origin". It is a chronic (long-lasting) disease that causes swelling, warmth, and pain of one or more small joints. Systemic JIA ia a rare and serious form of JIA. Systemic" means it may affect not only the joints but other parts of the body, including the liver, lungs and heart. sJIA is more severe and can be more challenging to diagnose and treat than other types of juvenile idiopathic arthritis. It is a lifelong disease for many patients and can continue into adulthood. This study will assess how safe and effective upadacitinib is in treating pediatric and adolescent participants aged 1 to < 18 with systemic juvenile idiopathic arthritis (sJIA) and will include a tocilizumab treatment arm for reference. Adverse events and change in the disease activity will be assessed. Upadacitinib is an investigational drug being developed for the treatment of sJIA. Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive upadacitinib or tocilizumab reference. In cohort 2, participants will receive upadacitinib. Approximately 90 participants with sJIA will be enrolled in approximately 45 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily or tocilizumab subcutaneous injection or intravenous infusion as per local label for 52 weeks and followed for approximately 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits/calls during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

NCT ID: NCT05609578 Recruiting - Clinical trials for Metastatic Lung Cancer

Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

Start date: November 28, 2022
Phase: Phase 2
Study type: Interventional

Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS <50% and KRAS G12C mutation

NCT ID: NCT05608954 Recruiting - Cerebral Palsy Clinical Trials

Effects of Physical Therapy on the Multisystems of Children With Cerebral Palsy: a Longitudinal Study

Start date: November 30, 2022
Phase:
Study type: Observational [Patient Registry]

Cerebral Palsy (CP) refers to childhood movement and posture disorders, whose severity, patterns of motor involvement and associated impairments are very varied. It is the most prevalent type of physical disability in children. Any non-progressive central nervous system (CNS) lesion that occurs in the prenatal, perinatal and postnatal period up to 2 years of life is considered CP. Thus, the present work aims to evaluate, monitor and verify the effects of physical therapy interventions on gross motor function, spasticity, balance, muscle activation, fatigue, respiratory system, functionality and social participation in children with cerebral palsy. This work will use some evaluation scales such as the Gross Motor Function Measure (GMFM-66), the Modified Ashworth Scale (MAS), the Early Clinical Assessment of Balance (ECAB), electromyography, the Fatigue Severity Scale and the Pediatric Functional Status. Scale. In addition to questionnaires, which will be applied directly to parents/caregivers, such as the Young Children's Participation and Environment Measure (YC-PEM), the PEDI (Pediatric Evaluation Disability Inventory) and the Goal Attainment Scaling (GAS).