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NCT ID: NCT04401748 Active, not recruiting - Clinical trials for Myelodysplastic Syndrome (MDS)

Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

Verona
Start date: September 10, 2020
Phase: Phase 3
Study type: Interventional

Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS. Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.

NCT ID: NCT04400864 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty Liver Disease

PALMED
Start date: December 30, 2019
Phase: N/A
Study type: Interventional

Non- alcoholic fatty liver disease (NAFLD) is one of metabolic syndrome manifestation, and has become the leading cause for cirrhosis and the need for liver transplantation. The Mediterranean diet showed in many trials its benefit in the treatment of the metabolic syndrome and NAFLD. The Paleolithic Diet includes meat, fish, fruits, vegetables, nuts and seeds and avoidance of processed food and most of carbohydrates. In some studies this diet seemed to decrease triglycerides levels and improve insulin resistance. The aim of this study is to evaluate the influance of the paleolithic diat for the treatment of NAFLD, as shown in the Mediterranean Diet.

NCT ID: NCT04399408 Completed - Clinical trials for Ultrasonography, Prenatal

Instinct™ Ultrasound Device Safety, Efficacy and Usability

Start date: May 6, 2019
Phase: N/A
Study type: Interventional

Mobile medical devices for self-patient-use, are a rapidly evolving component of telehealth. Study examines the feasibility of using the INSTINCT® device, a portable self-use ultrasound system attached to a commercial smartphone in remote pregnancy assessment. Study aims to evaluate its safety, efficacy and usability.

NCT ID: NCT04398836 Not yet recruiting - Crohn Disease Clinical Trials

Preoperative Nutrition for Crohn's Disease Patients

Start date: September 2020
Phase: Phase 3
Study type: Interventional

The investigator hypothesizes that compliance to Exclusive enteral nutrition (EEN) will be high among patients on an operation for their bowel disease, compared to the compliance rate seen in the general Crohn's Disease (CD) population. Also,the investigator hypothesizes that clinical outcomes would improve, and post-operative complication rate will be reduces in malnourished CD patients receiving pre-operative 4 weeks EEN during the 4 weeks post-surgery, compared to CD patients receiving high energy and protein diet without EEN.

NCT ID: NCT04398524 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of the Oropharynx

A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC

Start date: July 1, 2021
Phase: Phase 2
Study type: Interventional

This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab.

NCT ID: NCT04397276 Active, not recruiting - Neoplasms Clinical Trials

A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors

Start date: July 10, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.

NCT ID: NCT04394546 Active, not recruiting - Stroke Clinical Trials

CHAMPION-AF Clinical Trial

CHAMPION-AF
Start date: October 15, 2020
Phase: N/A
Study type: Interventional

The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

NCT ID: NCT04394403 Recruiting - Stress Clinical Trials

Pilot Internet-based Self-Help Program for Managing Corona (COVID-19) Stress

CoronaStress
Start date: May 14, 2020
Phase: N/A
Study type: Interventional

The current study examines an adapted guided self-help stress reduction program, focusing on reducing stress in the time of COVID-19. Two studies are planned: 1) an international study in English in which individuals proficient in English throughout the world will participate and 2) a follow-up study in Hebrew.

NCT ID: NCT04393532 Recruiting - Clinical trials for Primary Umbilical Hernia

Laparoscopic Primary Umbilical Hernia Repair With Routine Defect Closure Using Su2ura Approximation Device

Start date: February 23, 2020
Phase: N/A
Study type: Interventional

Intended Use The Su2ura™ Approximation Device is indicated for tissue approximation in endoscopic and open surgery for the placement of interrupted or running stitches in soft tissue such as hernia repair Objectives To assess the safety and efficacy of the Su2ura approximation device for the laparoscopic repair of primary umbilical hernia Number of Subjects 45 patients Number of Centers Two study centers in Israel and one in Slovenia. Study Duration 6 months Study Procedures Surgery will be performed under general anesthesia. Standard antibiotic prophylaxis will be administered at induction of anesthesia. A single surgeon, the PI, will perform the procedure. A surgical assistant will be selected by the PI from the surgical staff of the department. The procedure will involve placement of laparoscopic ports, reduction of the hernia sac, closure of the defect with the Su2ura approximation device and fixation of mesh with tacks over the closed defect. Study follow up visits: at post operation discharge, 14 days, 3 months, 6 months. Study follow up procedures: Also include SAE's and SADE's during follow up 1. Quality of life questionnaire: patient-reported satisfaction and function will be assessed through the validated, hernia-specific European Hernia Society Quality of Life questionnaire (EuraHS-QoL) 2. Clinical testing to determine hernia recurrence and clinical bulging Statistical analysis The sample size calculation based on the Exact Binomial distribution. The investigators will compute the 95% confidence intervals for a binomial probability, relying on the Clopper-Pearson (exact) method.

NCT ID: NCT04392726 Recruiting - Clinical trials for Diffuse Parenchymal Lung Disease

Ultra-Low Dose Computed Tomography For Diagnosis And Follow-Up Of Patients With Diffuse Parenchymal Lung Disease (DPLD)

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

The primary intention of this study is to determine the diagnostic performance of ultra-low-dose CT (ULDCT) in diagnosis and follow-up of diffuse parenchymal lung disease (DPLD). We hypothesize that inspiratory and expiratory chest ULDCT has comparable diagnostic yield to standard dose chest High-resolution computed tomography (HRCT) and utility for follow-up of patients with known DPLD. We will study this hypothesis through the following aims: 1. Determine whether inspiratory and expiratory ULDCT are comparable to HRCT in identifying mosaic attenuation due to air-trapping. 2. Determine whether ULDCT is as good as HRCT for follow-up of patients with established DPLD to identify disease progression.