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NCT ID: NCT04819074 Recruiting - Aneurysm, Brain Clinical Trials

Prediction of Outcomes After Surgery for Unruptured Intracranial Aneurysms

PRAEMIUM
Start date: May 20, 2021
Phase:
Study type: Observational

Accurate preoperative identification of patients at high risk for adverse outcomes would be clinically advantageous, as it would allow enhanced resource preparation, better surgical decision-making, enhanced patient education and informed consent, and potentially even modification of certain modifiable risk factors. The aim of the Prediction of adverse events after microsurgery for intracranial unruptured aneurysms (PRAEMIUM) study is therefore to develop and externally validate a clinically applicable, robust ML-based prediction tool based on multicenter data from a range of international centers.

NCT ID: NCT04818671 Active, not recruiting - Clinical trials for Generalized Myasthenia Gravis

Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis

ADAPTSC+
Start date: April 26, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection. Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).

NCT ID: NCT04818502 Active, not recruiting - Clinical trials for Mitral Valve Regurgitation

Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

RESOLVE-MR
Start date: May 4, 2021
Phase:
Study type: Observational

To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

NCT ID: NCT04818476 Recruiting - Barrett Esophagus Clinical Trials

Outcomes of Endoscopically Resected High-risk Mucosal and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus

Start date: February 10, 2020
Phase:
Study type: Observational

The purpose of this study is to assess lymph node metastasis rate, distant metastasis rate, disease-specific mortality, and overall mortality in patients with Barrett's related T1b and high risk T1a esophageal adenocarcinoma (EAC) who underwent a diagnostic endoscopic resection.

NCT ID: NCT04817774 Active, not recruiting - Clinical trials for End Stage Renal Disease

Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients

STEADFAST
Start date: March 17, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of TX200-TR101 and its effects on the donated kidney in living donor kidney transplant recipients. TX200-TR101 is a product made from a kidney transplant recipient's own immune cells, which are genetically modified and designed to help the transplant recipient's body accept their donated kidney and prevent their immune system from rejecting it.

NCT ID: NCT04817618 Recruiting - C3G Clinical Trials

Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.

APPEAR-C3G
Start date: July 28, 2021
Phase: Phase 3
Study type: Interventional

The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol. The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.

NCT ID: NCT04815928 Recruiting - Clinical trials for Coronary Artery Disease

Registry of Patients That Have Undergone ICA or PCI

ICA-PI
Start date: July 1, 2020
Phase:
Study type: Observational [Patient Registry]

In Invasive Coronary Angiography there are multiple invasively obtained measurements to determine the funcitonal significance of Cornary Artery Disease. In this Registry, patients who have undergone Invasive Coronary Angiography or Percutaneous Coronary Intervention are included to investigate diagnostic and prognostic implications of the invasive measurements.

NCT ID: NCT04815005 Recruiting - Clinical trials for Homozygous Familial Hypercholesterolemia

HoFH, the International Clinical Collaborators Registry

HICC
Start date: January 24, 2017
Phase:
Study type: Observational [Patient Registry]

Homozygous familial hypercholesterolemia (HoFH), a rare inherited disorder caused by bi-allelic mutations in the LDL Receptor pathway, is characterized by extremely elevated levels of low-density lipoprotein cholesterol (LDL-C) from birth and premature atherosclerotic cardiovascular disease (ASCVD). Our current knowledge about HoFH is disjointed and largely stems from relatively small case series and expert opinion. HICC (Homozygous FH International Clinical Collaborators) is a global consortium of clinicians who are contributing de-identified data of patients diagnosed with HoFH with the goal to advance our understanding of this rare disease.

NCT ID: NCT04814953 Enrolling by invitation - Clinical trials for Squamous Cell Carcinoma

HRQoL Keratinocyte Carcinomas

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

Rationale: Keratinocyte skin cancer is known to influence the HRQoL in a specific way. Derived utility values are required for cost-effectiveness analyses of new interventions. However there is no sensitive tool to capture HRQoL that translates into utilities available. Objective: To document the exact HRQoL in patients with in KC using the generic EQ-5D-5L questionnaire, as well as the TTO, 15D and the BaSQoL questionnaire, and to develop health utilities based on these tools. Study design: Longitudinal observational study (at time 0 and time 0 +12 months). Study population: Patients aged ≥18 years consulting a dermatologist or their GP for diagnosis, treatment or follow-up of a (pre)malignant skin lesion(s).

NCT ID: NCT04814693 Recruiting - Acute Pancreatitis Clinical Trials

Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis

RESOlVE
Start date: September 2, 2022
Phase: N/A
Study type: Interventional

In acute pancreatitis, approximately 20% of the cases result in severe necrotizing pancreatitis which is associated with significant morbidity and mortality. Necrotizing pancreatitis is characterized by the development of an acute necrotic collection and as this collection persists beyond 4 weeks, walled off necrosis (WON) encapsulates the collection. To date, this is treated by the step-up approach, which contains percutaneous drainage and minimally invasive video assisted retroperitoneal debridement (VARD) or endoscopic ultrasound (EUS) guided drainage followed by direct endoscopic necrosectomy (DEN). Different DEN techniques are available for the treatment of WON, however, there is a lack of effective endoscopic instruments to perform DEN. Recently, the first dedicated alternative to conventional DEN has been cleared for use, namely the EndoRotor® Resection System. This device is a powered mechanical debridement device intended for use in endoscopic procedures to resect and remove necrotic debris during DEN for WON. Previous (pilot and feasibility) studies showed promising results in terms of the amount of procedures, adverse events and length of hospital stay. Therefore, aim of this study is to assess the performance of the EndoRotor, as compared to conventional endoscopic techniques, for direct endoscopic necrosectomy (DEN) of walled off necrosis (WON) in a randomized controlled trial.