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NCT ID: NCT04733833 Completed - Severe COVID-19 Clinical Trials

A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With COVID-19

Start date: January 26, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this Phase 2 study is to test safety, efficacy, and tolerability of an oral preparation of VB-201 in patients with severe COVID-19

NCT ID: NCT04732949 Completed - COVID-19 Clinical Trials

Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19

SPRINTER
Start date: January 12, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.

NCT ID: NCT04721002 Completed - Clinical trials for Multiple Myeloma (MM)

Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)

MEDICI
Start date: July 7, 2021
Phase:
Study type: Observational

Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to assess t(11;14) and BCL2 expression in adult participants with newly diagnosed and relapsed/refractory (R/R) MM. Approximately 500 adult participants with newly confirmed or relapsed/refractory (R/R) multiple myeloma (MM) will be enrolled in around 15-20 countries. Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.

NCT ID: NCT04718844 Completed - Clinical trials for Non-transfusion-dependent Thalassemia

A Study Investigate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Response of SLN124 in Adults With Alpha/Beta-thalassaemia and Very Low- and Low-risk Myelodysplastic Syndrome

Start date: April 14, 2021
Phase: Phase 1
Study type: Interventional

This study will investigate the safety and tolerability of SLN124 in patients with Thalassaemia or patients with Very Low- and Low-risk Myelodysplastic Syndrome (MDS) after single ascending s.c. doses and multiple doses in healthy male and female subjects. Up to 7 cohorts of 56 patients with Thalassaemia and up to 7 cohorts of 56 patients with MDS will be enrolled. Each subject will receive single or multiple doses of SLN124 or placebo given by subcutaneous (s.c) injection.

NCT ID: NCT04716998 Completed - Covid19 Clinical Trials

Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19

Start date: January 14, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

An open label clinical study to evaluate the safety and the efficacy of MesenCure, an allogeneic cell therapy product, for the treatment of the pulmonary manifestations in COVID19 patients

NCT ID: NCT04716296 Completed - Clinical trials for Deep Brain Stimulation

Ketamine in Deep Brain Stimulation (DBS) Surgery

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Deep brain stimulation (DBS) is a well-established and effective treatment for motor symptoms resulting from idiopathic Parkinson's disease (PD). During the DBS surgery , a brain electrode is implanted in the basal ganglia, which is involved in the pathophysiology of the disease. The surgery consists of three steps: 1. Opening the skin, drilling the skull bone and inserting a temporary electrode. 2. Recording electrical activity of the brain, electrical stimulation of the brain which guide the implantation of the electrode.3 Transferring wires and implanting a subcutaneous pacemaker battery in the chest area. Today, standard treatment protocols consist undergoing the second stage (or first and second stage, depending on the treatment center protocol) of the surgery awake (under local anesthesia only). As systemic anesthetics affect cerebral electrical activity and prevent patient cooperation, they inhibit precise identification of the cerebral target under 'physiological navigation' guided by electrical recording and brain stimulation. As a result, the accuracy of electrode implantation decreases. However, undergoing surgery in an awake format often causes severe patient discomfort and anxiety necessitating shortening the length of surgery or aborting the surgery. As such there is a need for establishing an alternative anesthesia protocol for DBS surgeries. Ketamine is considered a unique anesthetic due to its hypnotic properties, analgesia, and possible amnesia. Standard doses of ketamine are currently used worldwide to treat patients with various injuries and brain diseases. Research from monkeys has shown that ketamine (in low dose) does not affect electrical brain activity used for physiological navigation. The investigators therefore propose a prospective , randomized , blinded study to evaluate the utility of low dose of ketamine in the second stage of DBS surgeries for increasing patient satisfaction and cooperation without detracting from the accuracy of physiological navigation to the cerebral target. This study will compare two treatment arms : Treatment arm consisting of patients randomized to receive a low dose of ketamine for the second stage of DBS surgery. Control arm consisting of patients randomized to receive sham control of saline during the second stage of DBS surgery.

NCT ID: NCT04714359 Completed - PTSD Clinical Trials

A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD

MAPPUSX
Start date: March 8, 2021
Phase: Phase 3
Study type: Interventional

This multi-site open-label study assesses the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants who were enrolled in a parent study for treatment of posttraumatic stress disorder (PTSD). The study will be conducted in up to N ≈ 100 participants. Participants will receive a flexible dose of MDMA, followed by a supplemental dose, unless contraindicated, during the Treatment Period with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The Primary Outcome measure is the change in PTSD Checklist (PCL-5) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) from Visit 3 is assessed at Visit 16. This study will compare the effects of three manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate alone (mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental dose (40 or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg.

NCT ID: NCT04709003 Completed - Covid19 Clinical Trials

Covid-19 Vaccine Effectiveness in Healthcare Personnel in Clalit Health Services in Israel (CoVEHPI)

CoVEHPI
Start date: December 23, 2020
Phase:
Study type: Observational

Although clinical trials for approved COVID-19 vaccines demonstrated efficacy of the vaccine in preventing symptomatic infection, many questions about vaccine effectiveness, such as the effectiveness of COVID-19 vaccine in preventing asymptomatic infection, a surrogate for transmission, and duration of protection, can only be evaluated in real-world trials. The objective of the study is to evaluate COVID-19 vaccine effectiveness (Pfizer vaccine, and, if available, Moderna vaccine) in preventing infection in healthcare personnel in Israel. HCP who are Clalit members and working in Soroka, Beilinson, Meir, Haemek, Kaplan and Schneider hospitals, 18 years or older, and eligible to get COVID-19 vaccine according to Ministry of Health guidelines, will be recruited, regardless of their intention to get the COVID-19 vaccine. A baseline serology sample and respiratory sample will be collected. Participants will be asked to provide a respiratory sample weekly for 3 months, and then monthly for the remainder of the study. Participants will also have blood drawn at 1 month, 3 months, 6 months, 9 months and 12 months. Respiratory samples will be tested for SARS-CoV-2 by RT-PCR; serology will be tested for SARS-CoV-2 antibodies. The study will last for 12 months. For each participant, data will be extracted from the Electronic Medical Record for the period of the study and retrospectively from 2010.

NCT ID: NCT04708925 Completed - Acute Pancreatitis Clinical Trials

Hypertriglyceridemia-associated Acute Pancreatitis: Apheresis Vs. Conservative Treatment

Start date: February 1, 2021
Phase:
Study type: Observational

Introduction: Hypertriglyceridemia is one of the etiologies of acute pancreatitis. It may cause severe multi-system disease resulting in high morbidity and mortality. There is controversy regarding the best method to treat it, which includes, among other therapies, high-dose insulin and performing plasma exchange (apheresis). Aims: Primary outcome - Comparison of 28- day mortality between hypertriglyceridemia-induced acute pancreatitis patients who received conservative therapy versus those who received apheresis therapy. Secondary outcomes: Comparison of morbidity parameters and rate of blood triglycerides level decrease between the groups. Materials and Methods: A retrospective study based on observational data collection, which will include all patients aged 18--99 who were admitted to the intensive care unit in 2010-2020 in the diagnosis of acute pancreatitis secondary to high blood lipids. Data will be collected from hospital files and computerized systems. Data will include demographics, admission times, ventilation days, pressor support, 28- day mortality,daily triglyceride level, medical history, APACHE-2 score, lactate level, need for dialysis, need for antibiotics and surgical intervention. The study will include 29 patients. All demographic and patient parameters will be statistically examined by a qualified statistician depending on the type of data.

NCT ID: NCT04697316 Completed - Clinical trials for Transcranial Direct Current Stimulation

Transcranial Direct Current Stimulation (tDCS) as a Cognitive Functioning Enhancement Treatment for ADHD Patients Compared to Healthy Controls

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

This study will examine the possible effects of tDCS (Transcranial Direct Current Stimulation) treatment to the left DLPFC on cognitive functions which were found to be deficient amongst ADHD patients. The study will include 100 subjects, 50 of whom diagnosed with ADHD. Subjects will complete the ASRS questionnaire to measure ADHD symptoms severity. Next, subjects will complete a series of cognitive tasks, after which they will receive either tDCS treatment or a sham treatment. Finally, subjects will repeat the cognitive tasks. Later that day, a telephonic follow up will take place. ADHD symptoms will be assessed again the next day.