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NCT ID: NCT04664790 Not yet recruiting - FASD Clinical Trials

Hyperbaric Oxygen Therapy Compared to Cognitive Training in FASD

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Fetal Alcohol Spectrum Disorder (FASD) describes a wide range of adverse physical, behavioral and cognitive effects resulting from prenatal alcohol exposure (PAE) during embryonic and fetal development. A number of clinical studies have presented evidence regarding the physiological effects of HBOT on metabolically dysfunctional brain regions that might be related to FASD. The aim of the study is to compare the effect of HBOT vs. neurocognitive training on neurobehavioral function in FASD.

NCT ID: NCT04663308 Recruiting - Clinical trials for Primary Sclerosing Cholangitis

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)

VISTAS
Start date: December 18, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.

NCT ID: NCT04662710 Active, not recruiting - Clinical trials for Advanced/Metastatic Gastroesophageal Adenocarcinoma

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)

LEAP-015
Start date: December 30, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer. The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.

NCT ID: NCT04662255 Active, not recruiting - Clinical trials for Lymphoma, Mantle-Cell

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

BRUIN-MCL-321
Start date: April 8, 2021
Phase: Phase 3
Study type: Interventional

This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

NCT ID: NCT04661930 Recruiting - Clinical trials for SARS-CoV-2 Infection

Fenofibrate for Patients With COVID-19 Requiring Hospitalization

FENOC
Start date: January 1, 2021
Phase: Phase 3
Study type: Interventional

This is an open-label run-in followed by a randomized, double-blind drug treatment study of COVID-19 infected patients requiring inpatient hospital admission.

NCT ID: NCT04660409 Recruiting - Clinical trials for Chronic Liver Disease and Cirrhosis

Assessment of the Correlation Between Serum Levels of Adropin and Degree of Severity of Chronic Liver Disease

Start date: November 25, 2020
Phase: N/A
Study type: Interventional

Injury to the liver parenchyma associated with an influx of acute or chronic inflammatory cells is termed hepatitis. Cirrhosis refers to a progressive, diffuse, fibrosing, nodular condition that disrupts the entire normal architecture of the liver. Patients with chronic liver disease have sustained hepatic inflammation, fibrosis, and aberrant hepatocyte regeneration. These abnormalities can cause cirrhosis and favor a series of genetic and epigenetic events that culminate in the formation of dysplastic nodules, which are actually preneoplastic lesions . Hepatocellular carcinoma can also arise in patients who have chronic liver disease but does not have established cirrhosis or marked inflammation. The "gold standard" for evaluation and follow up of liver fibrosis and cirrhosis is liver biopsy. It's a costly procedure with risks of severe complications, with sampling error and problematic long term follow up. Non-invasive tools are broadly used with good results, but none of the commonly used methods is perfect. In one meta-analysis, different methods were compared for diagnosis of cirrhosis in Non-alcoholic fatty liver disease (NAFLD) patients. For example (sensitivity; specificity): APRI (56.2% ;83.6%), FibroScan M Probe (78.2%; 90.8%), MRE (86.6%; 93.4%) . Child-Pugh classification and model for end-stage liver disease (MELD) scores are used as measures for assessment of degree of severity of liver disease. These models have some drawbacks; Ascites and encephalopathy included in Child-Pugh classification are subjective and may be variable according to the physician's judgment and the use of diuretics and lactulose. INR which appears in both methods does not sufficiently reflect coagulopathy and liver function and is also variable throughout different laboratories. Both are not sensitive enough for short interval periods. One of the major complications of cirrhosis and chronic hepatitis is Hepatocellular carcinoma (HCC). Most guidelines recommend cirrhotic patients to undergo abdominal ultrasound every 6 much to detect HCC, given the expected tumor growth rate in the target population. Although widely use, the combination of ultrasound (US) with Alpha fetoprotein (AFP) is not recommended for surveillance in patients with active liver inflammation as the 6-8% gain in the detection rate does not counterbalance the increase in false positive results. Like in previous issues, a specific, cost effective marker is still needed. Adropin is a 76-amino-acids secreted peptide, which is encoded by the Enho gene. The exact physiological role of Adropin in the liver is unknown. However, high levels of Adropin are correlated with low incidence of Type 2 Diabetes Mellitus, higher levels of HDL cholesterol, lower body-mass index (BMI), LDL cholesterol, Triglyceride levels and blood pressure. Obesity has been recognized long ago as a significant risk factor for developing cancer and is an independent risk factor for HCC in patients with alcoholic (odds ratio 3.2) and cryptogenic (odds ratio 11.1) cirrhosis Serum Adropin levels were decreased and negatively correlated with liver injury in non-alcoholic steatohepatitis (NASH) mice. Knockout of Adropin significantly exacerbated hepatic steatosis, inflammatory responses and fibrosis in mice. Furthermore, the treatment with Adropin bioactive peptides slowed NASH progression in mice. In search for a good diagnostic and prognostic marker in patients with liver disease, Adropin should be further investigated in humans. In this Open-label, single-center study, 50 adults (>18) male and female with any degree of chronic liver disease will undergo a single blood test for serum levels of Adropin. Levels will be measured using ELISA technique. The results will be compared with the Child Pugh and MELD scores, liver enzymes, lipid profile, coagulation factors and fibroscan results based on the patients' clinical data.

NCT ID: NCT04660344 Recruiting - Clinical trials for Muscle-invasive Bladder Cancer

A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

IMvigor011
Start date: May 3, 2021
Phase: Phase 3
Study type: Interventional

This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy.

NCT ID: NCT04660266 Not yet recruiting - Clinical trials for Ultrasound Therapy; Complications

Accuracy of Ultrasound Exam, Including Doppler and Elastography, in the Diagnosis of VOD, Following Bone Marrow Transplantation

Start date: December 2020
Phase: N/A
Study type: Interventional

The purpose of the study: Validation of the use of intentional ultrasound examination, which includes Doppler and elastography for the diagnosis of obstructive venous disease of the liver within 21 days after bone marrow transplantation. Protocol: Patients who are planned for a bone marrow transplantaion will be recruited for the study by the staff of the Transplant Department. Inclusion criteria: Patients over the age of 18 before a bone marrow transplantation. Eligibility criteria: Transplanted under 18 years of age Research protocol: After informed consent, patients will undergo an ultrasound examination before the transplant. After 14 days and again after 21 days patients will undergo two more US exams, If there is a change in their clinical condition the patients will undergo additional examination accordingly. At the same time on the 14th and 21st day a clinical evaluation will be performed by the clinical physician in the transplant department based on clinical criteria of European Blood and Brain Transplant Association (EBMT). The results of the clinical evaluation and blood test results will be collected. Patients will be divided into two groups: - Control group: Patients who did not develop VOD( veno occlusive disease ) during 21 days. - Study group: Patients who developed VOD during 21 days. All ultrasound examination data will be compared between the two groups in In addition will be collected: - Demographics - age, sex. - Background diseases including heart and liver diseases. - Basic disease as a transplantation cause. All data will be collected anonymously and coded separately.

NCT ID: NCT04659538 Completed - Clinical trials for Transcatheter Aortic Valve Replacement

The CAPTIS® Study - Embolic Protection in TAVR

Start date: November 24, 2020
Phase: N/A
Study type: Interventional

This is a First in Human study with the Filerlex CAPTIS device designed to demonstrate the safety and feasibility of the device in subjects undergoing Transcatheter Aortic Valve Replacement (TAVR)

NCT ID: NCT04658082 Completed - Type 2 Diabetes Clinical Trials

A Pilot Trial of the Non-invasive H.G.R Glucometer

Start date: October 7, 2020
Phase: N/A
Study type: Interventional

A pilot study evaluating the accuracy of a non-invasive glucose monitor (GWave) with venous glucose measured by core laboratory during a glucose tolerance test (GTT) in patients with type 2 diabetes. The study is conducted on 5 subjects undergoing a 75gr GTT, with blood glucose measured at baseline and at 8 time points up to 180 minutes post glucose ingestion both by GWave non-invasive glucometer and by core lab glucose measurement.