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NCT ID: NCT04555421 Not yet recruiting - Clinical trials for Overweight and Obesity

Using the Lumen Device for Prediabetes Prevention

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

To examine the effect of using Lumen on metabolic parameters and anthropometric variables. This will be done from baseline to the end of a 12 weeks intervention in adults with prediabetes..

NCT ID: NCT04551027 Not yet recruiting - Schizophrenia Clinical Trials

Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental Illness

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

The aim of this study is to assess the efficacy of a short term compensatory cognitive group intervention - the Compensatory Cognitive Training (CCT) among people with severe mental illnesses, receiving ambulatory treatment

NCT ID: NCT04548843 Not yet recruiting - Clinical trials for Primary Mitochondrial Diseases

A First in Human Study to Evaluate the Safety of Infusion of MNV-BM-PLC (Autologous CD34+ Cells Enriched With Placenta Derived Allogeneic Mitochondria) in Patients With Primary Mitochondrial Diseases Associated With Mitochondrial DNA Mutation or Deletion

Start date: March 2022
Phase: Phase 1
Study type: Interventional

The study objectives are to evaluate the safety of a single intravenous (IV) infusion of autologous CD34+ cells enriched with placenta-derived allogeneic mitochondria in participant with primary mitochondrial disease associated with mitochondrial DNA mutations or deletions. 6 participants aged from 4 to 18 years old on the day of screening visit with primary mitochondrial disease associated with mitochondrial DNA mutations or deletions will be enrolled.

NCT ID: NCT04522583 Not yet recruiting - Myocardial Ischemia Clinical Trials

Increased CRP Concentrations in Patients Admitted to the Emergency Department With Troponin Elevation Aids to Rule Out Coronary Ischemia

Start date: September 2020
Phase:
Study type: Observational

The investigators hypothesized that the CRP/troponin ratio measured in patients presenting to the ED with elevated troponin levels could differentiate between patients with cardiac ischemia and those who present due to a systemic inflammatory or infectious disease. The aim of the study was to determine the necessary CRP/troponin ratio required to rule out cardiac ischemia in a large ED population and determine its impact on long-term prognosis.

NCT ID: NCT04519463 Not yet recruiting - Analgesia Clinical Trials

The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing

Start date: September 2020
Phase: Early Phase 1
Study type: Interventional

This study aims to investigate the effect of local nasal anesthesia with lidocaine spray on the insertion of nasal tampons during active nasal bleeding.

NCT ID: NCT04482998 Not yet recruiting - Clinical trials for Acute Acoustic Trauma

Efficacy of Various Treatments for Acute Acoustic Trauma.

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

Acute acoustic trauma is a growing concern in the IDF. there is currently no accepted treatment. The present retrospective study is intended to evaluate the efficacy of different treatment modalities in the IDF between 01/01/2010 and 15/06/2020.

NCT ID: NCT04454151 Not yet recruiting - Clinical trials for Familial Adenomatous Polyposis

Azithromycin Treatment for Readthrough of APC Gene Stop Codon Mutations in Familial Adenomatous Polyposis

FAP
Start date: August 1, 2020
Phase: Phase 4
Study type: Interventional

Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world with a lifetime risk of 6%. Etiology is complex, while genetic background significantly affects the risk. Around one third of all genetic disorders as well as most cases of Familial Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur as a result of premature nonsense mutations (creating a stop codon) in an individual's adenomatous polyposis coli (APC) gene. Nonsense mutations are single-point alterations in the DNA that prematurely halt the protein translation process, producing a shortened, nonfunctional protein. In many of these cases, if the cell can be 'persuaded' to ignore the premature stop codon signal, the resulting protein may be able to ameliorate or stop the disease. Recently, members of the aminoglycoside family of antibiotics have been found to induce ribosomal read-through of nonsense mutations, leading to expression of a full length, functional protein. Investigators have recently shown that members of the aminoglycoside and macrolide antibiotic families can induce read-through of the nonsense mutations in the APC gene and lead to reduced oncogenic phenotypes in CRC cells and in different mice models. The aim of this project is to determine the ability of the macrolide antibiotic-Azithromycin to induce read-through of the nonsense mutations in the APC gene and to induce expression of a full length, functional APC protein in patients suffering from FAP and to tests its effect on adenoma number and size and on desmoid tumors in these patients. The future goal is to maximize the effect of stop-codon suppressors on APC while minimizing side effects. In this study the investigators will select FAP patients which carry APC nonsense mutations, treat them with Azithromycin PO for 4-6 months and examine colonic and duodenal adenomas as well as abdominal desmoid tumors, that will be documented before during and after treatment. In parallel, investigators will test polyp, adenoma and desmoid tissue samples as well as blood samples from these patients for changes in expression levels of the APC protein and related oncogenic markers. Suppression of nonsense mutations within the APC gene should be of benefit for patients suffering from FAP, attenuated FAP or multiple adenomas and for patients with advanced or diffuse CRC. Furthermore, given the rapid progress being made in the identification of different nonsense mutations in human genes that lead to mostly non-curable disease, the identification of clinically approved compounds that suppress nonsense mutations and that can be administered long-term without significant side effects would open new venues in the treatment of genetic human diseases that arise from pre-mature stop codons in important coding sequences. Immediate goal: establish the ability of Azithromycin to read-through APC nonsense mutation in FAP patients. The read-through effect of Azithromycin will be clinically tested by counting and measuring the number and size of both colonic and duodenal adenomas before and over treatment and by measuring the size of known desmoid tumors. Samples of the adenomas and desmoid tumors will be tested by western blot, immunofluorescence and immunohistochemistry for restoration of APC expression and changes in oncogenic markers. These experiments should be conducted within 6 month. Long term objective: 1. Determine the lowest dose of Azithromycin that can inhibit growth of colonic neoplasia and CRC in patients expressing a truncated APC protein due to nonsense mutations. 2. Examine the ability of a panel of additional macrolide antibiotics to induce APC nonsense mutation suppression using in-vitro methods. Investigators will focus on macrolide antibiotics that are currently in clinical use and are administrated for long terms. These objectives should take around 4 month and will be conducted in parallel.

NCT ID: NCT04447950 Not yet recruiting - Spondylolisthesis Clinical Trials

Randomized Control Trial of Quadratus Lumborum Block for Lumbar Spine Decompression and Fusion Surgery

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

Lumbar spinal decompression and fusion is a commonly performed procedure fro neural impingement and back pain from a variety of pathologies. The importance of pain control in the postoperative period for spinal surgery has been discussed and proven extensively, with both immediate and delayed reduction in complications and improved clinical results. Quadratus lumborum (QL) block was introduced in 2007 and is performed under ultrasound guidance for perioperative pain management in various surgeries.However, the plane for a posterior QL block can be easily reached during open midline spinal surgery. The investigators hypothesize that the posterior QL block is an effective analgesic tool for lumbar laminectomy surgery, because in lumbar laminectomy the quadratus lumborum is already exposed and is in direct visual contact. For that reason it is imperative to test the benefits of this procedure. This is a double blinded randomized control study to assess the results of intra-operative QL block performed for lumbar decompression and fusion.

NCT ID: NCT04438837 Not yet recruiting - Clinical trials for Coronavirus Disease 2019 (COVID-19)

Hydroxychloroquine Post-Exposure Prophylaxis for Coronavirus Disease (COVID-19) Among Health-Care Workers

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

Background: The rapid spread and high infectivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) makes identifying an effective prophylaxis agent highly important. One of the important target populations for such intervention who are at high risk of exposure are health care workers (HCWs) who may develop disease and/or expose patients and other HCWs. Hydroxychloroquine (HCQ), currently in usage for treatment of severe Coronavirus Disease 2019 (COVID-19), has in addition to in-vitro activities of inhibition of virus replication and immunomodulation, an important role in the inhibition of pre-entry step of the virus to host cells. Such activity in the early stage of infection may play a role in prevention of disease progression. Objectives: To evaluate the effect of HCQ in prevention of clinical disease and reduction of viral shedding among HCWs following exposure to confirmed COVID-19 patients. Study design: Multi-center, randomized controlled, superiority, open label trial Setting: The study will be conducted at Rambam Health Care Campus. Eligibility: Participants eligible for inclusion will include non-pregnant adult (>18 years old) HCWs who were exposed to a confirmed case of COVID-19 without full adherence to droplet precautions. Participants will be eligible in a period no longer than 72 hours after exposure. Intervention: HCQ will be given in the intervention group in a dosage regimen of 400mg BID in the first day followed by 200mg BID for overall 10 days. Participants in the control group will receive no treatment. Treatment will be started no longer than 72 hours following exposure. Outcomes: The primary outcome will be the number of participants who develop clinical signs compatible with COVID 19 (defined in full protocol) within 14 days of exposure. Secondary outcomes will include virologically-confirmed COVID 19, disease severity (need for hospitalization, mechanical ventilation and 30-day mortality) and viral shedding duration (time between first positive PCR to last of two consecutive negative tests) for confirmed COVID 19 cases. Sample size: The trial will test for HCQ's superiority assuming a primary outcome incidence of 20% in the control group and a reduction of 50% with HCQ. The sample size required for a power of 80% (alpha 0.05) is 291 participants per each group.

NCT ID: NCT04408144 Not yet recruiting - Infertility Clinical Trials

Addition of Dydrogesterone to the Luteal Phase Support After Fresh Embryo Transfer

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Randomized controlled study, open label to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.