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NCT ID: NCT03944681 Completed - Clinical trials for Arrhythmia, Droperidol

Gender Influence on Torsadogenic Actions of Droperidol.

Start date: April 23, 2019
Phase: N/A
Study type: Interventional

Postoperative nausea and vomiting (PONV) is a quite common complication affecting patients undergoing general anesthesia. There are a few pharmacological agents of well known effectiveness in reducing the risk of PONV. One of them is droperidol, which is a butyrophenone derivant. It has been widely used for the prevention and treatment of PONV due to its high effectiveness and low cost. Though, droperidol has a relevant side effect, that is a repolarization prolongation. This can lead to life-threatening cardiac arrhythmias: polymorphic ventricular tachycardia (torsades de pointes, TdP) that can degenerate into ventricular fibrillation and cardiac arrest. This was a reason why in 2001 the FDA issued a "black box" warning on droperidol. Ever since papers focused on this problem have described the influence of small doses of droperidol on TdP genesis as weak. This could be explained by the fact, that QT/QTc (corrected QT) interval prolongation, which represents prolonged cardiac repolarization on ECG, is not the sole determinant of a drug's potential to cause arrhythmia. Another electrocardiographical marker of torsadogenic action is increased transmural dispersion of repolarization (TDR). TDR represents differences in the repolarization between myocardial "layers" (like epicardium, endocardium, myocardium cells). It is believed that the induction of QT/QTc lengthening must coexist with TDR increase at the same time to promote torsadogenic changes. It has been known, on the basis of research, that females have been more potent to torsadogenic actions of pharmacological agents than males. That could be related to estrogen influence on ECG parameters, which had been proven on animal model. It hasn't been investigated, whether gender is an important factor when considering droperidol's torsadogenic potential. The aim of this study is to answer a hypothesis, that women are more potent to torsadogenic actions of droperidol in comparison with men.

NCT ID: NCT03940768 Completed - Cancer Clinical Trials

The Use of Lactobacillus Plantarum 299v in Treatment of Cancer Patients Who Received Home Enteral Nutrition

Start date: May 10, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to assess the impact of Lactobacillus plantarum 299v on nutritional status, tolerance of enteral diet and the quality of life. Administration of this probiotic may potentially improve nutritional status and tolerance of enteral diet. It also may provide positive effect on quality of life.

NCT ID: NCT03940586 Completed - Clinical trials for Cytomegalovirus (CMV) Infection

Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)

Start date: August 8, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age (adolescents); Age Group 2: From 2 to <12 years of age (children); and Age Group 3: From birth to <2 years of age (neonates, infants and toddlers). All participants will receive open label LET for 14 weeks (~100 days) post-transplant, with doses based on body weight and age.

NCT ID: NCT03940196 Completed - Ovarian Cancer Clinical Trials

Effect of Tumor Treating Fields (TTFields, 200 kHz) Concomitant With Weekly Paclitaxel for the Treatment of Recurrent Ovarian Cancer (ENGOT-ov50 / GOG-3029 / INNOVATE-3)

Start date: March 22, 2019
Phase: Phase 3
Study type: Interventional

The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) concomitant with weekly paclitaxel for the treatment of recurrent ovarian cancer . The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

NCT ID: NCT03934216 Completed - Ulcerative Colitis Clinical Trials

Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis

Start date: July 1, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

NCT ID: NCT03932682 Completed - Influenza, Human Clinical Trials

Efficacy Study With QIVc in Pediatric Subjects

Start date: May 13, 2019
Phase: Phase 3
Study type: Interventional

This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of Reverse transcription polymerase chain reaction (RT-PCR) confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.

NCT ID: NCT03930732 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation

BOREAS
Start date: April 15, 2019
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate-or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by - Annualized rate of acute moderate and severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on - Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo - Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) - Pre-bronchodilator FEV1 over 52 weeks compared to placebo - Lung function assessments - Moderate and severe COPD exacerbations - To evaluate safety and tolerability - To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies (ADA)

NCT ID: NCT03928743 Completed - Clinical trials for Ankylosing Spondylitis

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

BE MOBILE 2
Start date: April 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).

NCT ID: NCT03928704 Completed - Clinical trials for Nonradiographic Axial Spondyloarthritis

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis

BE MOBILE 1
Start date: April 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active nonradiographic axial spondyloarthritis (nr-axSpA).

NCT ID: NCT03927144 Completed - Episodic Migraine Clinical Trials

Study of Sustained Benefit of AMG334 in Adult Episodic Migraine Patients

Start date: May 15, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the sustained long-term benefit between two treatment paradigms of migraine prophylactic agents (erenumab versus a control arm of oral prophylactics) in episodic migraine patients who have previously failed 1 to 2 prophylactic migraine treatments.