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NCT ID: NCT04798456 Recruiting - Caregivers Clinical Trials

Aiming for a Better Understanding and Improvement of the Diagnosis and Prognosis of Patients With Disorders of Consciousness Through Multimodal Observations

PerBrain
Start date: June 1, 2020
Phase:
Study type: Observational

Improved treatment of severe brain injuries has resulted in increased survival rates. While some of these patients regain consciousness after a transient state of coma, others may develop a disorder of consciousness (DoC). Diagnosis of DoC currently relies on standardized behavioral assessment. The importance of accuracy in such diagnosis cannot be overstated, as it guides critical decisions on treatment (including pain management), and could underlie end-of-life decisions. Despite this importance, current behavioral diagnosis often fails, if because of the major sensory and motor deficits associated with DoC, or because of the heterogeneous etiology and pathophysiology associated with the condition. Finally, the need for accurate diagnosis and prognosis transcends the needs of the patients alone: caregiving of these patients is very stressful, principally for the large uncertainty associated with them. Thus, more accurate diagnosis and prognosis provide major relief for caregivers, and paradoxically, even if the news is not "good". For all these reasons it is critical to developing personalized diagnosis and prognosis prediction tools that permit a stratified analysis at the single-patient level. The PerBrain Project will benefit from the multidisciplinary partners' expertise, and the unique opportunity to perform longitudinal assessments in four clinical sites through both established and novel electrophysiological, neuroimaging, and physiological techniques. Based on the collected data, the investigators will develop a multimodal personalized diagnostic tool for DoC patients using state-of-the-art computational tools, such as machine learning, in order to better determine the current state (diagnosis) and future outcome (prognosis). The overall aim of this project will provide for a better understanding of the pathophysiological mechanisms in DoC, which will, in turn, allow personalized rehabilitation strategies, and improved single-patient predictions of state and prognosis.

NCT ID: NCT04798261 Recruiting - Pulmonary Embolism Clinical Trials

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

Start date: June 25, 2021
Phase:
Study type: Observational

The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).

NCT ID: NCT04797780 Recruiting - Clinical trials for Myelodysplastic Syndromes

Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome

Start date: February 8, 2021
Phase: Phase 3
Study type: Interventional

This study compares the efficacy of Tamibarotene in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha (RARA) positive, and newly diagnosed with higher-risk myelodysplastic syndrome (HR-MDS), and who have not received treatment for this diagnosis. The primary goal of the study is to compare the complete remission rate between the two treatment arms.

NCT ID: NCT04797260 Recruiting - Clinical trials for Severe Combined Immunodeficiency Due to RAG1 Deficiency

Phase I/II Clinical Trial Stem Cell Gene Therapy in RAG1-Deficient SCID

RAG1-SCID
Start date: July 23, 2021
Phase: N/A
Study type: Interventional

This study is a prospective, non-randomized, open-label, two-centre phase I/II intervention study designed to treat children up to 24 months of age with RAG1-deficient SCID with an indication for allogeneic hematopoietic stem cell transplantation but lacking an HLA-matched donor. The study involves infusion of autologous CD34+ cells transduced with the pCCL.MND.coRAG1.wpre lentiviral vector (hereafter called RAG1 LV CD34+ cells) in five patients with RAG1-deficient SCID.

NCT ID: NCT04796844 Recruiting - Asthma Clinical Trials

MANI Real-life Perspective Observatory

MANI
Start date: May 1, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry aims is to collect a large number of patients with mild and moderate asthma in a real-word conditions for a perspective observation of epidemiological evolution of the disease in relation to the therapeutic interventions available currently and in the near future.

NCT ID: NCT04796545 Recruiting - Clinical trials for Age-Related Macular Degeneration

Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration

Start date: September 13, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to demonstrate the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant in improving vision in patients with central vision impairment associated with end-stage Age-related Macular Degeneration (AMD). Eligible patients will be implanted with the SING IMT device and will be followed-up for a period of 12-months with post-operative ophthalmic exams and low-vision rehabilitation sessions.

NCT ID: NCT04796350 Recruiting - Osteoporosis Clinical Trials

RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

Start date: April 24, 2021
Phase: N/A
Study type: Interventional

A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a treatment group and a control group. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.

NCT ID: NCT04796337 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

SOTERIA
Start date: May 12, 2021
Phase: Phase 3
Study type: Interventional

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

NCT ID: NCT04796324 Recruiting - Clinical trials for Metastatic Breast Cancer

Anti-tumor Effect of Ixabepilone in Metastatic Breast Cancer (mBC) Selected by the Ixabepilone DRP.

Start date: March 1, 2021
Phase: Phase 2
Study type: Interventional

The purpose is to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the Ixabepilone DRP after failure of an anthracycline and taxanes.

NCT ID: NCT04796142 Recruiting - Clinical trials for Medication Reconciliation

Medication Reconciliation in Oncologic Patients

PROF2
Start date: June 12, 2019
Phase: N/A
Study type: Interventional

To improve medication reconciliation in oncologic patients in healthcare transitions through an alliance between a Cancer Institute and the community pharmacies and a new integrated IT platform.