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NCT ID: NCT04458831 Recruiting - Plasma Cell Myeloma Clinical Trials

A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

IONA-MM
Start date: August 13, 2020
Phase:
Study type: Observational [Patient Registry]

Primary Objective: To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice To describe safety of isatuximab in routine clinical practice (based on adverse event [AE] reporting) To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20) Secondary Objective: Not applicable

NCT ID: NCT04458051 Recruiting - Clinical trials for Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

PERSEUS
Start date: August 13, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168

NCT ID: NCT04455841 Recruiting - Anemia Clinical Trials

INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

Start date: March 19, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.

NCT ID: NCT04453267 Recruiting - Clinical trials for Coronary Artery Disease

DNA Repair in Patients With Stable Angina.

DECODE II
Start date: February 5, 2020
Phase:
Study type: Observational

Markers of DNA damage and repair are present in both atherosclerotic plaques and peripheral blood mononuclear cells of patients with coronary artery disease. A positive correlation has been observed between the level of DNA damage and the severity of atherosclerotic lesions, as well as atherogenic risk factors such as smoking, hypertension and hyperlipidaemia. A number of in-vitro studies have implicated defective DNA repair in the development and progression of atherosclerotic lesions. In mouse models of atherosclerosis, the DNA repair signalling cascade has been shown to be amenable to pharmacological intervention and overexpression of specific repair proteins attenuate the development of atherosclerotic plaques. However, data regarding the role of DNA repair in the pathogenesis of atherosclerosis in humans are lacking. We have preliminary data indicating reduced DNA repair activity in patients with stable angina. This study will determine the molecular basis and the biological consequences of this observation.

NCT ID: NCT04450862 Recruiting - Anxiety Clinical Trials

Anxiety Self-management Intervention for Pulmonary Hypertension

Start date: August 5, 2020
Phase: N/A
Study type: Interventional

Pulmonary hypertension (PH) is a disorder of high blood pressure that impacts the heart and lungs. Approximately, 50% of individuals with PH experience anxiety or panic disorders. There is limited evidence on psychological treatments for anxiety in PH; however, results support the use of Cognitive Behavioural Therapy (CBT). Despite the prevalence and impact of anxiety in PH; there are no widely available and/or disease specific pathways, thus highlighting an unmet need in this population. This project aims to develop and pilot, using randomised control trial methodology, a self-management intervention for individuals with PH based on principles of CBT.

NCT ID: NCT04449874 Recruiting - Colorectal Cancer Clinical Trials

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Start date: July 29, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

NCT ID: NCT04449783 Recruiting - Cancer Clinical Trials

Preoperative Shielding and N/T RT-PCR Swabbing for Elective Cancer Surgery

CHICANE
Start date: June 25, 2020
Phase:
Study type: Observational

trial to assess the effectiveness of pre-operative screening for COVID-19 in patients undergoing elective cancer surgery.

NCT ID: NCT04449406 Recruiting - Clinical trials for Pancreatic Ductal Adenocarcinoma

Early Detection of Pancreatic Adenocarcinoma (PDAC) Using a Panel of Biomarkers

UroPanc
Start date: January 1, 2020
Phase:
Study type: Observational

Urine and blood samples are being collected from patients with and without diseases of the pancreas. These samples will be tested with the aim of developing an accurate way of diagnosing diseases of the pancreas using the results.

NCT ID: NCT04445259 Recruiting - Critical Illness Clinical Trials

Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury

Start date: June 20, 2020
Phase:
Study type: Observational

The aim is to describe the epidemiology and determine the independent risk factors for mortality and acute organ injury in AKI and to assess the impact of different treatment strategies on survival. This will allow the development of prevention strategies and design of appropriately powered intervention studies.

NCT ID: NCT04445012 Recruiting - Clinical trials for Heart Valve Diseases

Cardiovascular Acoustics and an Intelligent Stethoscope

CAIS
Start date: October 24, 2019
Phase:
Study type: Observational

The aim of the project is to develop an artificial intelligence software capable of analysing heart sounds to provide early diagnosis of a variety heart diseases at an early stage. Since the invention of the stethoscope by Laennec in 1816, the basic design has not changed significantly. Our software could be coupled with existing electronic stethoscopes to create an 'intelligent' stethoscope that could be used by healthcare assistants or practice nurses to screen for sound producing heart diseases. It could also be used at home by patients who would otherwise go undiagnosed. The study investigators at Cambridge University Engineering Department (CUED) have developed a proof-of-concept AI algorithm to detect heart murmurs. However, in order to accurately detect the specific pathology and severity underlying the murmur, more heart sound recordings (matched with the ground truth from the patient's echocardiogram) are required. Patients presenting to one of the partner hospitals requiring an echocardiogram as part of their routine care will be invited to consent to this study. Participation will entail recording of a patient's heart sounds using an electronic stethoscope as well as collection of routine clinical data and a routine clinical echocardiogram at a single routine out patient visit.