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NCT ID: NCT04353817 Completed - Cystic Fibrosis Clinical Trials

A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes

Start date: June 19, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function (MF) mutation (F/MF genotypes).

NCT ID: NCT04352582 Completed - COVID-19 Clinical Trials

COVID-19 and Vaccination Attitudes

VACAT
Start date: April 14, 2020
Phase:
Study type: Observational

The investigators want to study how the exposure to the covid-19 pandemic affects attitudes towards science and vaccination, and how other general attitudes and values are affected.

NCT ID: NCT04351802 Completed - COVID-19 Clinical Trials

CORonavirus (COVID-19) Diagnostic Lung UltraSound Study

COR-DLUS
Start date: May 11, 2020
Phase:
Study type: Observational

This observational study is designed to assess whether focused lung ultrasound examination can improve the diagnosis of COVID-19 lung disease and/or make an alternative diagnosis at a patient's initial hospital presentation. For patients with confirmed COVID-19 the study will also assess whether surveillance lung ultrasound examination can predict clinical outcome over the course of their hospital admission.

NCT ID: NCT04351542 Completed - Flu Like Illness Clinical Trials

Ayurveda for Flu Like Illness During Covid-19 Outbreak

Start date: March 6, 2020
Phase: N/A
Study type: Interventional

This study aimed to evaluate the efficacy and safety of Ayurveda in reducing symptoms of flu like illness during the Covid 19 outbreak.

NCT ID: NCT04350736 Completed - Clinical trials for Acute Lung Injury (ALI) Associated With COVID-19

First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19

Start date: April 23, 2020
Phase: Phase 1
Study type: Interventional

This is a phase 1 study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903.

NCT ID: NCT04350593 Completed - COVID-19 Clinical Trials

Dapagliflozin in Respiratory Failure in Patients With COVID-19

DARE-19
Start date: April 22, 2020
Phase: Phase 3
Study type: Interventional

This is an international, multicenter, parallel-group, randomized, double-blind, placebo controlled, study in hospitalized adult patients with coronavirus disease 2019 (COVID-19) in the United States, Brazil, Mexico, Argentina, India, Canada, and United Kingdom. The study is evaluating the effect of dapagliflozin 10 milligrams versus placebo, given once daily for 30 days in addition to background local standard of care therapy, on reducing complications and all-cause mortality, or improving clinical recovery.

NCT ID: NCT04350463 Completed - Neoplasms Clinical Trials

A Safety and Efficacy Study of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers

Start date: July 14, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label, multi-cohort study to assess safety and efficacy of CC-90011 in combination with nivolumab in subjects with small cell lung cancer or squamous non-small cell lung cancer who have progressed after 1 or 2 lines of therapies. The primary objectives of the study are to evaluate the overall response rate of subjects treated with CC-90011 in combination with nivolumab in three cohorts: - Cohort A: SCLC in ICI naïve subjects - Cohort B: SCLC in ICI progressor subjects - Cohort C: sqNSCLC in ICI progressor subjects Overall response rate is defined as the proportion of subjects in the treated population who had complete response (CR) or partial response (PR) as assessed by Investigator review per RECIST v1.1. In Cohort A, expected ORR for nivolumab monotherapy is 14% while target ORR is 30%. To achieve at least 80% power with one-sided type 1 error 0.1, 39 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 12 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 2 or more subjects responding, Cohort A will continue to enroll an additional 27 subjects. If 1 or less subjects respond in stage 1, Cohort A will stop for futility. In Cohort B and C, expected ORR for nivolumab monotherapy is 5% while target ORR is 15%. To achieve at least 80% power with one-sided type 1 error 0.1, 48 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 14 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 1 or more subjects responding, Cohort B and C will continue to enroll an additional 34 subjects each. If 0 subjects respond in stage 1, Cohort B and C will stop for futility.

NCT ID: NCT04350411 Completed - Breast Cancer Clinical Trials

Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction

Start date: October 31, 2016
Phase: N/A
Study type: Interventional

Electrosurgery allows for dissection with simultaneous haemostasis. One of its disadvantages is that the heat production can cause injury to the surrounding tissue which may result in wound healing problems and an increased rate of seromas. The PEAK PlasmaBlade™ (PPB) is a new electrosurgery device which may overcome this by having the ability to operate on a lower temperature, therefore reducing collateral thermal damage. Different experimental studies in both animal and human models comparing the PEAK PlasmaBlade™ and other surgical dissection devices for incisions have shown a reduction in width of zone of thermal injury, reduction in wound inflammation, increased wound strength and reduced scaring in favour of the PEAK PlasmaBlade™ and comparable to scalpel incisions. A prospective clinical study published by Dogan et al. in 2013, including 46 consecutive breast cancer patients receiving a modified radical mastectomy either with the conventional diathermy (n=22) or the PEAK PlasmaBlade™ (n=24), showed a statistically significant reduction in wound fluid production (p=0.025), leading to earlier drain removal (p=0.020) in the PEAK PlasmaBlade™ group. Comparable to oncological breast surgery, prolonged drain requirements for high wound fluid production and seromas are often experienced in the abdominal donor side after deep inferior epigastric perforator/ muscle sparing transverse rectus abdominis muscle flap (DIEP/MS-TRAM) breast reconstruction. To evaluate the effects of the PEAK PlasmaBlade™ for abdominal dissection in autologous breast reconstruction on wound fluid production and complications such a seroma, this double blinded randomised controlled clinical trial was conducted. It was hypothesised the use of the PEAK PlasmaBlade™ for the harvest of the DIEP/ MS-TRAM flap would result in 1) a shorter abdominal drains requirement (days); 2) a lower total drainage volume (mL) from the abdominal drains; 3) lower levels of inflammatory cytokines in the drain fluid and 4) less and smaller seromas would be identified using ultrasound in the follow-up period.

NCT ID: NCT04350112 Completed - Cancer Clinical Trials

Study of Opioid-Induced Constipation 1 Project

StOIC-1
Start date: August 21, 2017
Phase:
Study type: Observational

The aim of the project is to investigate opioid-induced constipation (OIC) in a real world / diverse group of patients with cancer. The objectives of the project are to determine: a) prevalence of OIC; b) clinical features / impact of OIC; c) management of OIC.

NCT ID: NCT04349904 Completed - Celiac Disease Clinical Trials

Near-Focus NBI Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation

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

There are no agreed endoscopic signs for the diagnosis of villous atrophy(VA) in coeliac disease(CD), necessitating biopsies and for both diagnosis and exclusion. Here we evaluated the role of near focus Narrow Band Imaging(NF-NBI) for the assessment of villous architecture in suspected CD with development and further validation of a novel NF-NBI classification.