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NCT ID: NCT04484168 Recruiting - Venous Ulcer Clinical Trials

Axial Ablation Versus Terminal Interruption of the Reflux Source

AAVTIRS
Start date: July 21, 2020
Phase: N/A
Study type: Interventional

This randomised trial aims to compare the effect on ulcer healing of different means of managing venous reflux in the lower limb. It is a non-inferiority trial comparing endovenous ablation of the axial (Saphenous and other large veins) veins of the lowere limb, versus terminal interruption of the reflux source (TIRS). For the purposes of this trial TIRS will be achieved using foam sclerotherapy of the distal tributaries in the immediate vicinity of the ulcer being treated.

NCT ID: NCT04475939 Active, not recruiting - Clinical trials for Lung Cancer, Non-Small Cell

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer

ZEAL-1L
Start date: October 26, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).

NCT ID: NCT04474197 Completed - Clinical trials for Alpha1-Antitrypsin Deficiency

Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ Genotype

Start date: July 24, 2020
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-864 in PiZZ subjects.

NCT ID: NCT04471103 Recruiting - Clinical trials for Consensus Development

Comparison of Multi-Round and Real-Time Delphi Survey Methods

Start date: August 13, 2021
Phase: N/A
Study type: Interventional

A two-group parallel randomised trial of Delphi survey methods.

NCT ID: NCT04468373 Terminated - Clinical trials for Age Related Macular Degeneration

Study of WA-NG (NG-IMT) Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration

Start date: May 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety of the updated Model WA-NG telescope prosthesis (hereafter WA-NG telescope), an injectable telescope device, in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.

NCT ID: NCT04464564 Recruiting - Clinical trials for Agitation in Patients With Dementia of the Alzheimer's Type

Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

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

This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.

NCT ID: NCT04463511 Recruiting - Hypothermia Clinical Trials

Placing Preterm Infants in Polyethylene Bags Immediately After Birth

Start date: July 13, 2020
Phase: N/A
Study type: Interventional

Primary objective: To determine if placing preterm infants in a polyethylene bag (PB) immediately after birth, before the umbilical cord is clamped, will increase the number of preterm infants with a normal temperature on admission to the Neonatal Intensive Care Unit (NICU).

NCT ID: NCT04460365 Completed - Clinical trials for Glaucoma, Open-Angle

European Nutrition in Glaucoma Management Trial

ENIGMA
Start date: October 1, 2017
Phase: N/A
Study type: Interventional

European Nutrition in Glaucoma Management (ENIGMA) trial will evaluate the effect of 18-month supplementation with lutein, zeaxanthin and meso-zeaxanthin on macular pigment (MP) levels, vision, cognition and serum biomarkers of inflammation and oxidative stress in glaucoma patients. This study comprises a randomised, placebo controlled and double masked clinical trial designed to establish MP response to supplementation with lutein, zeaxanthin and meso-zeaxanthin over an 18-month period. The study will also investigate the relationship between macular pigment, cognitive function, oxidative stress and inflammation, and determine the impact of dietary supplementation on vision, retinal structure, quality of life and cognitive function among glaucoma subjects.

NCT ID: NCT04460352 Recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer

NEEDS
Start date: November 27, 2020
Phase: Phase 3
Study type: Interventional

NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the first co-primary endpoint overall survival and superiority for the experimental intervention definitive chemoradiotherapy. A second co-primary endpoint is global health related quality of life (HRQOL) one year after randomisation. A third co-primary endpoint is eating restictions one year after randomisation. The aim is to compare outcomes after neoadjuvant chemoradiotherapy with subsequent esophagectomy to definitive chemoradiotherapy with surveillance and salvage esophagectomy as needed in patients with resectable locally advanced squamous cell carcinoma (SCC) of the esophagus, with the aim to provide generalisable guidance for future clinical practice.

NCT ID: NCT04459117 Active, not recruiting - Extreme Prematurity Clinical Trials

Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen

TREOCAPA
Start date: October 29, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

TREOCAPA is a Phase II/III European Multicentre study concerning the prophylactic treatment by Acetaminophen of extremely preterm infant during the first five days after birth. The Phase II is a dose finding phase in order to assess the minimum effective dose regimen of acetaminophen for the closure of PDA for neonates with a gestational age less than 27 weeks This part of the study will be conducted in 11 NICUs, in 4 countries (France, UK, Finland and Denmark). The Phase III is The phase III is a randomized, multicenter, double-blind, placebo-controlled superiority trial, two arms in a 1:1 ratio, evaluating an increasing of 10% of the percentage of survival without severe morbidity at 36 weeks of post menstrual age. In the intervention arm, 20 mg/kg followed by 7.5 mg/kg quarter in die (QID) will be administered to the 27-28 weeks gestational age group (dosage confirmed through PK/PD data analysis from the previous Finnian study) and the dosage selected after the conclusion of the Phase II will be administered to the 23-26 weeks gestational age group. A group sequential design, with a total of 3 analyses (2 interim analyses and a final) and the O'Brien-Fleming alpha spending function is chosen for the trial. At the same time, a Bayesian sequential analysis is planned for safety endpoints