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NCT ID: NCT04543591 Recruiting - Clinical trials for Thrombotic Microangiopathy

Ravulizumab in Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplant

Start date: December 10, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab in adult and adolescent participants with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In Stage 1, an open-label, single-arm period, the dosing regimen will be confirmed. In Stage 2, participants will be randomized to receive either blinded ravulizumab plus best supportive care or matching placebo plus best supportive care. The treatment period is 26 weeks (open-label for Stage 1, and randomized, double-blind, and placebo-controlled for Stage 2) followed by a 26-week follow-up period.

NCT ID: NCT04542538 Completed - Sepsis Clinical Trials

The Impact of Premorbid Illnesses on the Risk of ICU Admission and Short-term Outcome

Start date: April 11, 2018
Phase:
Study type: Observational

The Corona virus disease 2019 (COVID-19) pandemic is currently involving all parts of the world. Several risk factors for critical illness and death from the disease have been proposed. However, it is still unclear if the observed associations between different comorbidities and chronic medications and severe COVID-19 disease and mortality is different from associations between the same factors and other severe diseases requiring intensive care unit (ICU) -care. This is important since some of the observed risk factors are very common in the aged who, by age alone, are more prone to a more severe course of any disease. By combining several registries, this study will compare, on several comorbidities such as hypertension and diabetes , the first 2000 cases of COVID-19 patients receiving critical care in Sweden to a Swedish sepsis-cohort and a Swedish adult respiratory distress syndrome (ARDS) -cohort.

NCT ID: NCT04542265 Completed - Clinical trials for Postprandial Glucose Regulation

Health Effects of Oat and Oat Bioactive in Human

Start date: August 28, 2020
Phase: N/A
Study type: Interventional

Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods

NCT ID: NCT04541979 Recruiting - COVID-19 Clinical Trials

Aerosoliserat DNase for Treatment of Respiratory Failure in Severe COVID-19

Start date: June 4, 2020
Phase: Phase 2
Study type: Interventional

Recent observations have suggested a role of neutrophil extracellular traps (NETs) in the pathophysiology of severe COVID-19. The aim of the study is to assess efficacy and safety of aerosolized DNase I to remove NETs and decrease respiratory distress in patients with COVID-19.

NCT ID: NCT04541589 Active, not recruiting - Sjogren's Syndrome Clinical Trials

Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome

TWINSS Extn
Start date: January 5, 2021
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201(NCT03905525). Additionally, this Extension study will further explore the pharmacokinetics (PK) and efficacy of iscalimab at two dose level.

NCT ID: NCT04541043 Active, not recruiting - Clinical trials for Primary IgA Nephropathy

Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)

Nefigard-OLE
Start date: November 14, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef-301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon.

NCT ID: NCT04540497 Active, not recruiting - Clinical trials for IgG4 Related Disease

A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

Start date: October 26, 2020
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).

NCT ID: NCT04536909 Recruiting - Kyphoscoliosis Clinical Trials

Indication and Treatment of Adult Kyphoscoliosis

INTRAKS
Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

Degeneration, iatrogenic-/idiopathic causes and fractures can lead to kypho- scoliotic deformities potentially resulting in pain and loss of function. The surgical strategies rely on surgeon preferences and type of deformity as well as clinical symptoms. The complication rate of surgical treatment is high. The aim of this study is to elucidate the indications for surgical treatment of kyphoscoliosis and evaluate the effectiveness of surgical and non-surgical outcome clinically and radiologically. The primary outcome for the PROMs and x-ray is at 12 months, but the investigators will also follow the patients with the PROMs and x-rays after 2,5 and 10 years.

NCT ID: NCT04535544 Active, not recruiting - Clinical trials for Hepatitis D, Chronic

A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

REEF-D
Start date: September 17, 2020
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.

NCT ID: NCT04534205 Recruiting - Clinical trials for Recurrent Head and Neck Cancer

A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1

AHEAD-MERIT
Start date: January 7, 2021
Phase: Phase 2
Study type: Interventional

An open-label, controlled, multi-site, interventional, 2-arm, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand -1 (PD-L1) with combined positive score (CPS) ≥1. This trial has two parts. Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, the Randomized part of the trial to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. For Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial.