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NCT ID: NCT05653349 Recruiting - Clinical trials for Primary Immune Thrombocytopenia (ITP)

Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)

VAYHIT1
Start date: March 6, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of two different doses of ianalumab versus placebo in addition to first-line corticosteroids in maintaining platelet count ≥30 G/L in adult participants with primary ITP.

NCT ID: NCT05653219 Recruiting - Clinical trials for Primary Immune Thrombocytopenia

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

VAYHIT2
Start date: January 21, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.

NCT ID: NCT05650879 Recruiting - Clinical trials for HER2-positive Metastatic Breast Cancer

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer

HER2
Start date: March 20, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses. A second main question is to evaluate the concentration of ELVN-002 in the blood at different doses and to see how this correlates with safety and see how the concentration of drug changes over time. The third main question is to see if ELVN-002 works to shrink cancers that have HER2 genetic abnormalities, particularly non-small cell lung cancer.

NCT ID: NCT05650814 Recruiting - Cancer Clinical Trials

Telematics Device for Daily Monitoring of Vital Signs in Cancer

ButterfLife
Start date: May 23, 2022
Phase: N/A
Study type: Interventional

The primary goal of this non-profit single-centre randomized pilot interventional study is to evaluate the acceptability of a daily telemonitoring of five vital parameters (heart rate, respiratory rate, blood oxygenation, blood pressure, and body temperature) using a medical device in advanced cancer patients with relevant cardiovascular and respiratory comorbidities assisted at home. In addition to the standard home care, participants in the intervention group will keep the medical device at home. They will register five vital parameters (heart rate, respiratory rate, blood oxygenation, blood pressure, and body temperature) once a day for eight weeks. Participants belonging to the control group will receive standard home care. The secondary goals of this study include the following: - Analyzing the effect of telemonitoring on patients' quality of life and psychological status. - Observing the possible effects of telemonitoring on the caregiver care burden. - Assessing the possible effects of telemonitoring on the caregiver perceived satisfaction with the home care received. - Comparing the number of physician and nurse home visits and phone calls between the patients using the device and patients in standard home care. - Comparing the number of emergency room visits, admissions, and hospitalization days between the patients using the device and patients in standard home care.

NCT ID: NCT05650567 Recruiting - Dermatomyositis Clinical Trials

Study of M5049 in DM and PM Participants (NEPTUNIA)

Start date: January 19, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.

NCT ID: NCT05649943 Recruiting - Clinical trials for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment

APPROACH
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Italian multicenter study, will enroll ~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide. After 6 months from the start of treatment, patients will be randomized to receive local treatment based on the investigator's choice ( either one between primary radiotherapy or cytoreductive prostatectomy), in addition to apalutamide, or to continue just with medical therapy.

NCT ID: NCT05649748 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)

Start date: March 7, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of the study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PAH from studies INS1009-201 (NCT04791514), INS1009-202 (NCT05147805) and other lead-in studies of TPIP in participants with PAH.

NCT ID: NCT05649722 Recruiting - Clinical trials for Pulmonary Hypertension

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Start date: May 11, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-211 (NCT05176951) and other lead-in studies of TPIP in participants with PH-ILD.

NCT ID: NCT05649384 Recruiting - Clinical trials for NSTEMI - Non-ST Segment Elevation MI

Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)

PRESC1SE-MI
Start date: December 1, 2020
Phase:
Study type: Observational

The PRESC1SE-MI study compares two algorithms for triage of patients presenting with chest pain and symptoms of heart attack (myocardial infarction) to the emergency department. Both algorithms are recommended by the European Society of Cardiology: the 0/3-hour algorithm and the 0/1-hour algorithm. Currently, most emergency departments worldwide use the 0/3-hour troponin algorithm. Cardiac troponin (cTn) is a heart-specific biomarker which indicates damage of the heart muscle and which increases after a heart attack. In the 0/3-hour algorithm, the amount of troponin in the bloodstream is measured with a high-sensitivity assay at admission and 3 hours thereafter. Likewise, the 0/1-hour algorithm means that the blood sample in which the troponin is measured is collected at admission and 1 hour later. Since recent clinical studies suggest that the 0/1-hour algorithm is superior to the 0/3-hour algorithm, many hospitals consider switching to the 0/1-hour algorithm. The aim of this study is to assess how feasible the time-saving 0/1-hour algorithm would be in reality and whether it provides the same accuracy and safety in the diagnosis of myocardial infarction as the current practice the 0/3-hour algorithm.

NCT ID: NCT05648968 Recruiting - Clinical trials for Warm Autoimmune Hemolytic Anemia (wAIHA)

A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia

VAYHIA
Start date: December 30, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment.