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NCT ID: NCT04559919 Recruiting - Epilepsy Clinical Trials

Prospective Regional Epilepsy Database

PREDICT
Start date: December 15, 2020
Phase:
Study type: Observational [Patient Registry]

PREDICT is an observational study following adults with an unprovoked seizure or epilepsy in the health care region of western Sweden. The objective is to identify biomarkers and/or genetic predisposition of relevance for diagnosis and/or treatment of epilepsy and study the long-term prognosis and consequences of epilepsy.

NCT ID: NCT04559425 Recruiting - Clinical trials for Heart Block Second Degree

Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block

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

Few studies are specifically designed to address health concerns that are already relevant during pregnancy. The consequence is a lack of evidence on best clinical practice. This includes mothers and their babies when pregnancy is complicated by an abnormally slow heart rate due to maternal antibody-mediated heart disease in the unborn baby (fetus). Since the late seventies, it has been possible to detect and monitor fetal disease by ultrasound images and to treat selected conditions with pharmaceuticals administered via the mother. To this day, physicians need to make decisions about the management of such pregnancies without evidence from prospective clinical trials on drug efficacy and safety. The SLOW HEART REGISTRY is a multi-centered prospective observational study that will address the knowledge gap to guide future management of high-degree immune-mediated heart block to the best of care. The study seeks to establish an international database of the management and outcome of affected fetuses, to be used to publish information on the results of currently available prenatal care and to evaluate the need for additional research.

NCT ID: NCT04558931 Recruiting - Multiple Myeloma Clinical Trials

Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma

Start date: June 2, 2021
Phase: Phase 2
Study type: Interventional

Prospective, single center, randomized, open label, parallel group, 2-arm study assessing the clinical benefit in term of enhancement of overall response rate of Isatuximab in combination with CellProtect as compared to Isatuximab for the treatment of patients with newly diagnosed multiple myeloma who are eligible for stem cell transplantation (SCT) as maintenance after SCT.

NCT ID: NCT04557059 Recruiting - Prostatic Neoplasms Clinical Trials

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer

PRIMORDIUM
Start date: November 12, 2020
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

NCT ID: NCT04550130 Recruiting - Clinical trials for Ulcerative Colitis (UC)

Dose-Evaluation Study of the Efficacy and Safety of TLA Gut™ Leukapheresis Treatment in Patients With Ulcerative Colitis

Start date: December 2022
Phase: N/A
Study type: Interventional

An open-label, randomised, multi-centre, dose evaluation study of the efficacy and safety of TLA Gut™ leukapheresis treatment in patients with UC. The aim of this trial is to evaluate the efficacy and safety of two different TLA Gut™ dose regimens in patients with acute exacerbation of UC. Enrolled patients will participate in a 6-week treatment phase and a 20- week follow-up phase. The treatment phase consists of two periods; 2 weeks in which patients will undergo two treatment sessions per week, followed by 4 weeks of a single treatment session per week. The follow-up phase consists of 2 visits, one visit at week 7 and the last visit at week 26. Telephone visits will be conducted between these visits. In all a patient will undergo 8 treatment visits and 2 follow-up visits. Only patients not having experienced an earlier recurrence will participate in the follow-up phase.

NCT ID: NCT04547426 Recruiting - Insulin Sensitivity Clinical Trials

Effects of Snuff and/or Red Wine om Metabolic Rate

Start date: August 31, 2020
Phase: N/A
Study type: Interventional

About 14 healthy participants, consume a standardized breakfast combined with either using regular or nicotine-free moist snuff. The metabolic rate is measured every hour for four hours on each occasion starting in the morning. Participants are also randomized to get red wine or non-alcoholic red wine to the meal.

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: 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: 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: 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.