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NCT ID: NCT04523324 Completed - Influenza Clinical Trials

Immunogenicity Trial of Recombinant Influenza Vaccine Among HCP in Israel

Start date: October 31, 2019
Phase: Phase 4
Study type: Interventional

This randomized, open-label, active-controlled trial will assess humoral immune responses to a single dose of 2019-20 recombinant hemagglutinin quadrivalent influenza vaccines (RIV4) compared with standard egg-based unadjuvanted quadrivalent influenza vaccines (IIV4) among healthcare personnel (HCP) vaccinated during the previous 2018-19 season with IIV4. The trial will be conducted at two hospital sites in Israel during the 2019-20 influenza season among HCP who were enrolled in the Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI).

NCT ID: NCT04523220 Completed - Hemodialysis Clinical Trials

Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis

CONVERT
Start date: August 28, 2020
Phase: Phase 2
Study type: Interventional

In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug. Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

NCT ID: NCT04522167 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration

MAGELLAN-AMD
Start date: July 21, 2020
Phase: Phase 3
Study type: Interventional

This is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.

NCT ID: NCT04519541 Completed - Clinical trials for Facet Syndrome of Lumbar Spine

RAMBAM 021: Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain

Start date: February 3, 2021
Phase: N/A
Study type: Interventional

Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain

NCT ID: NCT04518384 Completed - Anastomotic Leak Clinical Trials

Risk Factors Associated With Anastomotic Leak and Perioperative Mortality in Elderly

Start date: August 6, 2017
Phase:
Study type: Observational

This is a retrospective cohort study of all consecutive patients who underwent colon or rectal resection, between the years 2012-2017 at Rabin Medical Center, a tertiary referral center in Israel. Data were obtained from patients' electronic medical files. The study was approved by the Institutional Review Board (IRB) of Rabin Medical Center (RMC). The study met the guidelines outlined in the Declaration of Helsinki. Due to the minimal risk nature of this study, the need for informed consent was waived by the IRB. Patient population: All patients aged 70 years and above who underwent large bowel resection were included in the analysis. Inclusion criteria were: age ≥70; all patients undergoing any colonic or rectal resection for benign or malignant etiologies in an open or minimally-invasive approach Exclusion criteria were: age<70; colon resection without anastomoses; re-operations during the same admission . Data retrieved included demographic data (age, gender, Charlson comorbidity score, place of residency, functional capacity, BMI), surgical data (indication for surgery, elective vs urgent surgery, surgical approach, length of surgery, peri-operative morbidity and mortality.All surgeries were performed by at least one senior surgeon. The surgical approach (laparoscopic or laparotomy) was at the senior surgeon's discretion and deemed most appropriate for the patient's problem, physiological status and underlying illnesses. The extent of the resection was according to oncological guidelines when relevant Endpoints: Primary endpoint was the occurrence of postoperative anastomotic leak. Secondary end-point was postoperative mortality Statistical Analysis The statistical analysis for this paper was generated using SAS Software. Continuous variables were presented by Mean±Std, Categorical variables were presented by (N, %). T-Test was used to compare the value of continuous variables between study groups and Fisher's exact test (for two groups) or Chi-square (for more than two groups) were used to compare the value of categorical variables between study groups. Two-sided p values less than .05 were considered statistically significant

NCT ID: NCT04518007 Completed - Clinical trials for Post Traumatic Stress Disorder

Hyperbaric Oxygen Therapy for Post Traumatic Stress Disorder

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

The study evaluates the effect of hyperbaric oxygen therapy on veterans with combat-associated PTSD in an double blind sham control study.

NCT ID: NCT04517370 Completed - Breast Cancer Clinical Trials

CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Given the need for an effective, non-hormonal treatment for Genitourinary syndrome of menopause GSM) symptoms in breast cancer survivors, the reported efficacy of fractional CO2 laser as such a treatment in retrospective studies, the study aims to evaluate the efficacy of CO2 laser for the treatment of GSM in breast cancer patients, in a prospective, randomized, blinded, placebo-controlled trial.

NCT ID: NCT04515823 Completed - Pregnancy Related Clinical Trials

Flat OGTT (Oral Glucose Tolerance Test) During Pregnancy

Start date: April 26, 2020
Phase:
Study type: Observational

The aim of the study is to examine the relationship between "flat" sugar curve on OGTT-glucose tolerance test during pregnancy, neonatal birthweight and other perinatal outcomes.

NCT ID: NCT04512820 Completed - Miscarriage Clinical Trials

Treatment of Missed Miscarriage With TRUCLEAR Tissue Removal System, a Feasiblity Study

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

the Aim of this study is to prospectively study the feasibility of evacuation of products of conception (POC) in missed miscarriages up to 10 weeks using the TRUCLEAR tissue removal system in order to achieve targeted treatment under direct vision of the POC and thus potentially reducing the risk of complications and intrauterine adhesions

NCT ID: NCT04509674 Completed - Clinical trials for Myocardial Infarction

EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)

Start date: December 16, 2020
Phase: Phase 3
Study type: Interventional

This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease. People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes. Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.