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NCT ID: NCT04696822 Completed - Anaphylaxis Clinical Trials

Bioavailability of Nasal Epinephrine

Start date: November 1, 2020
Phase: Phase 1
Study type: Interventional

A Study to Compare the Bioavailability of Epinephrine following a Single Nasal Dose of FMXIN002 Microspheres Powder with Epinephrine 0.3 mg Intramuscular Injection in Adult Subjects with Seasonal Allergic Rhinitis with and without Nasal Allergen Challenge

NCT ID: NCT04696055 Completed - Clinical trials for Hepatocellular Carcinoma

Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors

Start date: February 3, 2021
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people diagnosed with liver cancer which may have spread to nearby tissue and is unlikely to be cured or controlled with treatment (advanced metastatic hepatocellular carcinoma, HCC). Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers will learn more about the trial treatment, regorafenib, in a small number of participants. They will study the results when the trial treatment is taken with another cancer treatment called pembrolizumab. There will be 2 parts to this trial. The part 1 (pilot phase) will include about 52 men and women. The part 2 (expansion phase) will include about 67 men and women. All of the participants will have HCC and will be aged 18 years or older. All of the participants will have tried other treatments that did not help their HCC. These other treatments (PD-1/PD-L1 Immune Checkpoint Inhibitors) are designed to work by stopping the activity of certain proteins in the immune system thought to play a role in HCC. During both parts of the trial, the participants will take regorafenib and receive pembrolizumab. In the pilot phase, there will be 2 groups of participants. The group that each participant joins will be based on the treatment they already received for their HCC. The researchers will review the results in each group to learn if regorafenib and pembrolizumab are helping one group of participants more than others. Outcome of this review will determine the population to be treated in the expansion phase.

NCT ID: NCT04693078 Completed - Colonic Polyp Clinical Trials

Detection of Colonic Polyps Via a Large Scale Artificial Intelligence (AI) System

Start date: May 18, 2020
Phase: N/A
Study type: Interventional

Colonoscopy is the gold standard for detection and removal of precancerous lesions, and has been amply shown to reduce mortality. However, the miss rate for polyps during colonoscopies is 22-28%, while 20-24% of the missed lesions are histologically confirmed precancerous adenomas. To address this shortcoming, the investigators propose a new polyp detection system based on deep learning, which can alert the operator in real-time to the presence and location of polyps during a colonoscopy. The investigators dub the system DEEP: (DEEP) DEtection of Elusive Polyps. The DEEP system was trained on 3,611 hours of colonoscopy videos derived from two sources, and was validated on a set comprising 1,393 hours of video, coming from a third, unrelated source. For the validation set, the ground truth labelling was provided by offline gastroenterologist annotators, who were able to watch the video in slow-motion and pause/rewind as required; two or three specialist annotators examined each video. This is a prospective, non-blinded, non-randomized pilot study of patients undergoing elective screening and surveillance colonoscopies using DEEP. The aim of the study is to: Assess the: 1. Number of additional polyps detected by the DEEP system in real time colonoscopy. 2. Safety by prospective assessment of the rate of adverse events during the study period attributed or not to the use of the DEEP system. 3. Stability of the DEEP system by measuring the rate of false positives (False Alarms) per colonoscopies 4 And to examine its feasibility and usefulness of in clinical practice by assessing the colonoscopist user experience while using the DEEP system in a 5 point scale.

NCT ID: NCT04690569 Completed - Acute Infection Clinical Trials

Establish MeMed BV™ Performance for Differentiating Bacterial From Viral Infection in Suspected Acute Infection Patients (APOLLO STUDY)

Apollo
Start date: May 3, 2019
Phase:
Study type: Observational

Prospective, multi-center, observational, blinded study, enrolling pediatric and adult subjects. Eligible ED\Urgent care and hospital admitted patients with symptoms consistent with acute bacterial or viral infection and healthy subjects will be recruited according to the eligibility criteria. Each participant will undergo a thorough investigation upon recruitment that includes documenting clinical, radiological, laboratory and microbiological information for determining their health status. Follow-up data will be collected via a phone call. Diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection will be assessed using an expert adjudication comparator method. The study will be run in a blinded fashion: site personnel will be blinded to the comparator method outcomes, and the expert panel will be blinded to the results of the index test. Results of the index test will not be revealed to the attending clinician and so will not influence patient management.

NCT ID: NCT04687072 Completed - Clinical trials for Primary Immune Thrombocytopenia

A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

ADVANCE SC
Start date: December 11, 2020
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.

NCT ID: NCT04685694 Completed - Clinical trials for Abortion Induced Complicated

Management of RPOC After Induced Abortion

RPOC
Start date: January 1, 2020
Phase: Phase 4
Study type: Interventional

Randomized trial comparing expectant management and medical management in women diagnosed with retained products of conception after first trimester induced abortion

NCT ID: NCT04685005 Completed - Fatigue Clinical Trials

"WakeUp" for Vigilance Following Lunch

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

This is a single center, double-blind, placebo and active controlled clinical trial comprised of a single drink of WakeUp beverage (in 3 doses) compared to Caffeine (100mg) and placebo given to health volunteers. Participants will be randomized regarding the order of the various beverages. Healthy volunteers or stable (under treatment) patients with chronic diseases) will be included. They will be studied 5 times, in a 2-14 days period, each time during noontime (between 11:30 and 15:00). Each day of the study, the participants will follow the following schedule: Lunch any time between 11:30 and 13:30 Time 0: Immediately after lunch a baseline set of assessment. Time 30min: Participants will then consume a beverage (which will be either placebo or 100mg caffeine or single/double/triple dose of WakeUp in the various days) Time 60min: Repeat the same set of assessments as done 30min after beverage Time 150min: Repeat the same set of assessments 2 hours after beverage Time 180min: End of day assessment

NCT ID: NCT04683835 Completed - Clinical trials for Mild Cognitive Impairment

Evaluation of Cognitive State in Senior Subjects Using Neurosteer EEG System

Start date: October 15, 2020
Phase:
Study type: Observational

This is an observational study. Patients who fulfill all inclusion criteria and none of the exclusion criteria will be enrolled in the study, be neurologically evaluated and will go through EEG recordings while listening to an auditory cognitive assessment tool. EEG recordings will be analyzed using proprietary computational analyses.

NCT ID: NCT04682418 Completed - Spine Fusion Clinical Trials

Pedicle Screw Placement With XVS

Start date: May 20, 2018
Phase: N/A
Study type: Interventional

Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system. Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists, using the Gertzbein score. Subjects will undergo intraoperative 3D scan prior to screws placement to enable 3D model rendering and XVISION SPINE system registration. Subjects will undergo intraoperative 3D scan post procedure to enable offline scoring of pedicle screw placement using the Gertzbein score. Surgeons performing the procedures will be requested to fill in usability questionnaires at the end of the procedure

NCT ID: NCT04680039 Completed - Clinical trials for Hypotension of Hemodialysis

Early Warning of Intradialytic Hypotension in Hemodialysis Patients

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

In this study, the investigators will monitor patients undergoing hemodialysis treatment with a non-invasive wearable PPG-based device. Measurements will include blood pressure, heart rate, oxygen saturation, stroke volume, cardiac output, cardiac index and systemic vascular resistance, among others. The aim is to diagnose intradialytic hypotension more rapidly than with current noninvasive methods and prevent related poor outcomes.