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NCT ID: NCT04280705 Completed - COVID-19 Clinical Trials

Adaptive COVID-19 Treatment Trial (ACTT)

Start date: February 21, 2020
Phase: Phase 3
Study type: Interventional

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

NCT ID: NCT04274738 Completed - Clinical trials for Waldenstrom's Macroglobulinemia

A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4

Start date: April 30, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to establish a pharmacologically active dose of mavorixafor in combination with ibrutinib based on pooled safety, clinical response, pharmacokinetic (PK) and pharmacodynamic (PD) data to select the recommended dose for a randomized registrations trial.

NCT ID: NCT04266665 Completed - Brain Tumor Clinical Trials

Effect of Dexmedetomidine on Brain Homeostasis and Neurocognitive Outcome

Start date: March 12, 2020
Phase: Phase 4
Study type: Interventional

Brain tumor surgery is commonly associated with different degrees of preoperative intracranial hypertension and surrounding tumor edema, elicited by tumor underlying pathophysiology. During craniotomy for brain tumor resection maintenance of hemodynamic stability and intracranial homoeostasis is of paramount importance. Disordered hemodynamics or adverse stress may activate the immune inflammation or neuroendocrine responses and lead to a surge of inflammatory mediators and stress hormones, which are implicated in secondary brain insults. Adverse physiological responses caused by intraoperative disordered hemodynamics or surgery-related damage, may lead to some secondary brain injury (such as cerebral edema or cerebral hemorrhage), aggravating damage to brain tissue and affecting the recovery from anesthesia, cognition and prognosis in patients. Prevention of secondary brain injury is a key-endpoint to improve clinical outcomes in glioma patients undergoing craniotomy. Alpha2-adrenoceptor agonists have been widely used for sedation, analgesia and anti-sympathetic actions for many years, but the definite evidence of their potential use as neuroprotectants has so far been confined to animal studies, yet the findings are inconsistent. Dexmedetomidine (DEX) has been demonstrated to be a new type a2 adrenergic receptor (a2-AR) agonist, which can selectively bind with the a1 and a2 adrenergic receptor, and playing a dual role by restraining the activity of sympathetic nervous and stimulating the vagus nerve. Dexmedetomidine (DEX) also plays an important role in in inhibiting inflammatory and neuroendocrine responses. Animal experiments showed that the right must have a dexmedetomidine neuro-protective effect. However, the brain-protective effect of dexmedetomidine in anesthesia of craniotomy resection of glioma has not been reported. Thus, the aim of this study was to explore the effect of dexmedetomidine on perioperative brain protection, as well as cerebral oxygenation and metabolic status aiming to provide a basis for clinical rational drug use in patients undergoing craniotomy resection of glioma.

NCT ID: NCT04263636 Completed - Presbyopia Clinical Trials

Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections

Start date: January 7, 2020
Phase:
Study type: Observational [Patient Registry]

Primary objective of this study is to construct and validate a modified luminous efficiency function that addresses the distinct total eye light transmittance of patients that underwent bilateral pseudophakic presbyopic correction with trifocal intraocular lenses (IOLs) implantations.

NCT ID: NCT04256278 Completed - Male Infertility Clinical Trials

Administration of Antioxidants to Infertile Men and Sperm Quality

Start date: February 28, 2020
Phase: N/A
Study type: Interventional

The purpose of this randomized clinical trial is to assess the effect of oral antioxidant administration to infertile men, by evaluating semen variables, sperm DFI and levels of ROS. Oral antioxidants or placebo will be given for 3 consecutive months. The study will recruit infertile men, who have one previous abnormal spermiogram, with at least one pathological variable (concentration, motility, morphology), according to WHO 2010 criteria. Participants will be recruited in the outpatient clinic of the Unit of Human Reproduction and of the Unit of Reproductive Endocrinology at the 1st Ob/Gyn Dept.

NCT ID: NCT04254211 Completed - Clinical trials for Inflammation in EVAR

Neutrophil-lymphocyte Ratio and Platelet-lymphocyte Ratio as Predictors for Adverse Events in EVAR

Start date: March 1, 2016
Phase:
Study type: Observational

This study investigated the association of chronic inflammatory markers with the clinical outcome after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm.

NCT ID: NCT04242836 Completed - Presbyopia Clinical Trials

Development and Validation of a Digital Optotype for Near Vision in Greek Language.

DeDART
Start date: March 28, 2019
Phase:
Study type: Observational [Patient Registry]

Primary objective of our study is to develop and validate a computer-based digital near-vision optotype based on the Greek version of the print MNREAD.

NCT ID: NCT04242446 Completed - Clinical trials for Hidradenitis Suppurativa

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

BE HEARD I
Start date: February 19, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

NCT ID: NCT04241900 Completed - Risk of Heat Stress Clinical Trials

Effect of Aging and Aerobic Fitness Level on Heat Dissipation

Start date: May 1, 2014
Phase: N/A
Study type: Interventional

In the context of global aging, the health risk factors associated with exercising or working in the heat for aging population are exacerbated by the rising in global surface temperatures. The purpose of this investigation is to determine at what age the heat loss decrements occur and to examine if aerobic fitness level can affect the heat loss capacity in neutral environmental conditions.

NCT ID: NCT04226911 Completed - Obesity Clinical Trials

Sweeteners and Sweetness Enhancers: Prolonged Effects on Health, Obesity and Safety

SWEET
Start date: January 30, 2020
Phase: N/A
Study type: Interventional

The aim of this randomised controlled trial (RCT) is to investigate if prolonged consumption of sweetener and sweetness enhancers (S&SEs) within a healthy diet approach will improve weight loss maintenance and obesity related risk factors, and affect safety markers, compared to sugar. We hypothesize, that: - Prolonged use of S&SEs in beverages and food matrices will result in improved body weight control because S&SEs will increase palatability of the diet and thereby increase compliance to the recommendations for a healthy diet. - There will be no safety concerns using S&SEs in the long term. Overweight/obese adults and families where at least one adult (both gender) and one child (both gender) are overweight/obese will be recruited. The majority of measurements will only be conducted in the adult population and some measurement will only be done in sub-groups. The intervention will be performed in four countries: Denmark, Greece, Spain and the Netherlands. The goal is approximately 370 participants - 330 adults (18-65 years of age) and 40 children (6-12 years of age) - will be recruited for the study. All adult participants are first treated by a low energy diet (LED) for 2 months with the aim to reduce body weight (minimum 5% weight loss (WL)), whereas children are treated separately with a conventional weight maintenance (WM) diet, without a specific aim for absolute WL. The participants - both adults and families - are randomized into two different diet interventions for 10 months with or without inclusion of S&SEs products (foods and drinks). For adults, this period aims at preventing weight re-gain and for children maintaining body mass index (BMI)-for-age. The participants will receive food exchange lists and will be guided by dieticians. The randomization will be stratified by age, sex and BMI. Adults (not participating with children) belonging to the same household and all members of a family will be assigned the same intervention - the randomization will here solely be based on the oldest adult in the family/household. The adult participants are weighed at months 0, 0.5 and 1, and if needed at month 1.5. They are supervised during the WL period at months 0 and 1, and if needed at months 0.5 and 1.5, and throughout the WM period at months 2, 4, 6, 9 and 12. Children will follow a similar, but less strict time schedule (their participation is preferred but not required for all dietician meetings). The main assessment points are the clinical investigation days (CIDs) at month 0 (baseline, start of the WL period), 2 (end of the WL period/start of randomized intervention), 6 (6 months from baseline) and 12 (1 year from baseline).