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NCT ID: NCT05121454 Completed - Clinical trials for Laparoscopic Surgery

Validation of Serenno CUO and IAP Measuring Device

Start date: November 15, 2021
Phase:
Study type: Observational

Serenno Medical Automatic Urine Output measuring device is intended to measure volumetric flow rate (total volume and rate) of urine produced per minute over long periods by a patient with a urinary catheter as well as high resolution IAP via bladder pressure (IBP). The device comprises a control unit located near the bed, and a disposable unit connected between the catheter and the urine collection tube/bag. The disposable unit is connected to the control unit with a tube. Frequent and accurate Intra-Abdominal Pressure measurements facilitate management of critical care patients, yet this parameter is normally measured manually, intermittently, and inaccurately. Automating IAP measurement will increase responsiveness, reduce workload, and potentially improve outcomes. The investigators goal is to validate the accuracy urinary catheter estimates of IAP compared to the gold standard during the application of a wide range of pressures controlled by a validated closed-loop insufflation reference. Primary Objective: The study objective is to evaluate the accuracy of the Serenno Medical IAP measurements in patients with indwelling urinary catheters vs. the gold standard - the Foley Manometer

NCT ID: NCT05120193 Completed - Atrial Fibrillation Clinical Trials

Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System

SPHERE Per-AF
Start date: December 14, 2021
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, randomized clinical evaluation of the Sphere-9 Mapping and Ablation Catheter with the Affera Mapping and Ablation System. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH® SF radiofrequency ablation catheter (control device).

NCT ID: NCT05119374 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Clinical Evaluation of SenseGuard™ to Detect Respiratory Changes, During Home Monitoring of Subjects With High Risk of AECOPD.

Start date: November 11, 2021
Phase: N/A
Study type: Interventional

This is an observational, open labeled study. The study aims to evaluate the capability of SenseGuard™ (SG) non-invasive wearable device, to detect, post-hoc, early respiratory changes due to exacerbation by daily monitoring of subjects with COPD, at home. Subjects with COPD, that were discharged following hospitalization due to AECOPD are most susceptible to experience another exacerbation during the first 6 months post admission. Hence, subjects that were discharged from the hospital due to AECOPD during the last 3 months are eligible to the study.

NCT ID: NCT05117034 Recruiting - Anesthesia Clinical Trials

Pre-emptive Intravenous Morphine for Acute Post-craniotomy Pain.

Start date: February 16, 2022
Phase: N/A
Study type: Interventional

We propose a double-blind randomized controlled trial to evaluate the effect of intravenously administered morphine at surgery conclusion on acute postoperative pain in patients recovering from craniotomy surgery. Participating adults having craniotomy surgery will be randomized in a 1:1 ratio to intraoperative intravenous administration of 0.08 mg/kg morphine at dura closure, or a matching placebo.

NCT ID: NCT05116189 Active, not recruiting - Ovarian Cancer Clinical Trials

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)

Start date: December 13, 2021
Phase: Phase 3
Study type: Interventional

The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

NCT ID: NCT05115318 Completed - Tourette Syndrome Clinical Trials

The Effect of Medical Cannabis on Tics, Premonitory Urge and Psychiatric Comorbidity in Adults With Tourette Syndrome

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

Medical cannabis (MC) is a standard treatment in Israel to adults with resistant Gilles de la Tourette syndrome (GTS). While small randomized control trials assessed THC efficacy on tics and premonitory urge, only small retrospective studies assessed MC efficacy and tolerability in GTS. Herein, By using an open-label, prospective design, our aim is to determine the preferred method of use, efficacy and tolerability of 12 weeks of treatment with MC in adult patients with GTS.

NCT ID: NCT05112315 Active, not recruiting - Kidney Diseases Clinical Trials

Clinical Impact of the iBox as an Early Intervention tooL

Start date: February 18, 2022
Phase: N/A
Study type: Interventional

International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.

NCT ID: NCT05111626 Recruiting - Gastric Cancer Clinical Trials

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer

FORTITUDE-102
Start date: March 14, 2022
Phase: Phase 3
Study type: Interventional

The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab. The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.

NCT ID: NCT05106504 Recruiting - Parkinson Disease Clinical Trials

Effect of Medical Cannabis for Non-motor Symptoms of Parkinson's Disease

Start date: September 2, 2021
Phase:
Study type: Observational

Medical cannabis (MC) is a standard treatment in Israel to Parkinson's disease (PD) patients suffering from pain. Nevertheless, it is not known about MC effectiveness for other non-motor symptoms of the disease. Our aim is to prospectively observe patients with PD before and after initiation of MC, for non-motor symptoms effect. In specific, relying of data from multiple sclerosis patients and basic science showing cannabinoid receptor 1 (CB1) is abundantly expressed in the sub epithelial layer of the bladder, we will explore the impact of MC on bladder function and urinary symptoms.

NCT ID: NCT05106218 Not yet recruiting - Laparoscopy Clinical Trials

Assessment of the SurroundScope in Urologic Surgical Procedures

Start date: March 2022
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope