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NCT ID: NCT04580628 Completed - Clinical trials for Prostate Hyperplasia

Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)

Start date: July 1, 2020
Phase:
Study type: Observational

Thuflep TLF: initial experience and results of prostate laser enucleation with fibrous thulium laser (TLF)

NCT ID: NCT04580563 Completed - Septic Shock Clinical Trials

Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study

PlasmaFaisa
Start date: October 22, 2020
Phase: N/A
Study type: Interventional

No randomized controlled trial (RCT) has investigated the effect of prophylactic fresh frozen plasma (FFP) transfusion in septic or critically ill patients with coagulation abnormalities. The last Surviving Sepsis Campaign therefore suggests with a very low quality of evidence "against the use of fresh frozen plasma during septic shock to correct clotting abnormalities in the absence of bleeding or planned invasive procedures". However, expert opinion highlights that FFP should be transfused "when there is a documented deficiency of coagulation factors (increased prothrombin time, international normalized ratio - INR, or partial thromboplastin time) and the presence of active bleeding or before surgical or invasive procedures". Disseminated intravascular coagulation (DIC) is responsible for such a severe deficiency of coagulation factors. Supplementing the intense deficit of coagulation factors with plasma containing non-activated coagulation factors is therefore a rational therapy in DIC patients. OctaplasLG® is a donor plasma product, with unique features compared to standard fresh frozen plasma: standardized concentrations of natural pro-/anti-coagulation factors; a standardized volume; pathogen free. OctaplasLG® should reduce the "inflammatory hit" on the endothelium, including the glycocalyx, by having standardized levels of coagulation proteins, which can give more sustainable support to the endothelial regeneration as compared to standard fresh frozen plasma.

NCT ID: NCT04580511 Recruiting - Clinical trials for Abdominal Wall Defect

Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction

PMCF_AWR
Start date: November 4, 2020
Phase:
Study type: Observational

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other types of fixation material. The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 112 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.

NCT ID: NCT04580485 Completed - Colorectal Cancer Clinical Trials

INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors

Start date: February 3, 2021
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)

NCT ID: NCT04580420 Recruiting - Clinical trials for End Stage Renal Disease

Safety & Efficacy of DCR-PHXC in Patients With PH1/2 and ESRD

PHYOX7
Start date: April 15, 2021
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate DCR-PHXC in participants with PH1 or PH2 and severe renal impairment, with or without dialysis.

NCT ID: NCT04580381 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort

RELEVANT
Start date: September 1, 2020
Phase:
Study type: Observational

Natalizumab (NTZ) use in Multiple Sclerosis (MS) in highly active patients has been largely established during the last Rationale 10 years in both clinical trials and real-world practice. Along with its efficacy, NTZ use has been limited by potential risk of progressive multifocal leukoencephalopathy (PML). Thus, several studies have tried to assess how to minimize this risk. One suggested approach is to move from the standard interval dose (SID) of 4 weeks to an extended interval dose (EID) of 5 weeks or longer. Extending the dosing interval of NTZ has been practiced by some physicians with the intention of improving the benefit/risk of the treatment by reducing the exposure-dependent risk of progressive multifocal leukoencephalopathy (PML) while maintaining efficacy. We propose to retrospectively analyze data from clinical records coming from RRMS patients treated in France at 5 different centers; Caen, Nice, Bobigny and Toulouse hospitals as well as Percy Military Hospital, to evaluate the effectiveness of natalizumab EID in subjects who have previously been treated with natalizumab SID for 12 months, in relation to continued SID treatment. In the clinical practice of these centers, patients are shifted after minimum 12 months under SID to an EID of 6 weeks regardless antibody JC serum status. Clinical, magnetic resonance imaging (MRI) and serum anti-JCV antibody status data are collected when available. The objective of this study is to assess the efficacy in term of ARR and safety.

NCT ID: NCT04580121 Completed - Clinical trials for Acute Myeloid Leukemia

A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420.

Start date: November 4, 2020
Phase: Phase 1
Study type: Interventional

This open-label, entry-into-human (EIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of RO7283420. Escalating doses of RO7283420 will be administered to participants with Acute Myeloid Leukemia (AML) in order to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).

NCT ID: NCT04580108 Completed - Clinical trials for Systemic Lupus Erythematosus

Highly Sensitive Serum Cardiac Troponin T and Cardiovascular Events in Patients With Systemic Lupus Erythematosus

TROPOPLUS
Start date: July 3, 2007
Phase:
Study type: Observational

Identification of biological markers able to better stratify cardiovascular risks in systemic lupus erythematosus patients is needed. We aimed to determine whether serum cardiac troponin T levels measured with a highly sensitive assay (HS-cTnT) may predict cardiovascular events in systemic lupus erythematosus.

NCT ID: NCT04579679 Active, not recruiting - Clinical trials for Neuroendocrine Tumours

Open-Label Surufatinib in European Patients With NET

Start date: August 13, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label, multi-centre study of surufatinib in patients with low to intermediate grade (Grade 1 or Grade 2), well-differentiated neuroendocrine tumours (NETs).

NCT ID: NCT04579666 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS)

Start date: September 30, 2020
Phase: Phase 2
Study type: Interventional

This is a 24-month, Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)