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NCT ID: NCT03770403 Completed - Clinical trials for Generalized Myasthenia Gravis

A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.

ADAPT+
Start date: March 1, 2019
Phase: Phase 3
Study type: Interventional

This is a Long-Term, Single-Arm, Open-Label, Multicenter Phase 3 follow-on trial of the ARGX-113-1704 study to evaluate the safety and tolerability of ARGX-113 in patients with gMG. Patients who have completed at least 1 cycle of treatment and at least 1 year of trial ARGX-113-1705 and have started Part B are eligible to enroll in the open-label trial ARGX-113-2002 to receive efgartigimod by SC administration.

NCT ID: NCT03769792 Completed - Delivery, Obstetric Clinical Trials

Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries

Start date: February 4, 2019
Phase: N/A
Study type: Interventional

The main purpose of the study is to evaluate the effectiveness and safety of the impedance spectroscopy device prototype in detection of anal sphincter injuries in women in the early postpartum period. The study is prospective. The study group comprises 24 patients; included in it 6-8 weeks after natural delivery. The planned participation of each patient in the study is up to 4 weeks and three visits will take place at that time. After obtaining written consent, at the screening visit (V0) each patient will undergo a physical examination, blood samples for laboratory tests and stool samples for calprotectin concentration assessment will be collected. On the second visit (V1), after the final verification of inclusion/exclusion criteria, impedance spectroscopy using tested device will be performed in each patient, the electrical impedance of pelvic floor muscles will be measured and the degree of anal sphincter damage will be evaluated. Full gynecological and proctological examination (including a gynecological speculum, two-handed examination, rectal examination and anoscopy) will be carried out. On the third visit (V2), two reference diagnostic tests (with evidenced effectiveness and safety), transanal ultrasonography and anorectal manometry, will be conducted. The collected data will be used to select the optimal therapeutic method for each participant individually.

NCT ID: NCT03766581 Completed - Clinical trials for Acute Ischemic Stroke

A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel

AXIOMATIC-SSP
Start date: January 27, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.

NCT ID: NCT03766425 Completed - Eye Diseases Clinical Trials

Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy.

Start date: June 14, 2017
Phase: Early Phase 1
Study type: Interventional

Comparison of efficacy and safety of Mitomycin and Aflibercept used to support primary trabeculectomy - a prospective, randomized trial in patients with open-angle glaucoma undergoing surgery.

NCT ID: NCT03764293 Completed - Clinical trials for Locally Advanced or Metastatic and Unresectable HCC

A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC

Start date: June 10, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.

NCT ID: NCT03761849 Completed - Huntingtons Disease Clinical Trials

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease

Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD)

NCT ID: NCT03761537 Completed - Atopic Dermatitis Clinical Trials

Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7

ECZTRA 7
Start date: December 13, 2018
Phase: Phase 3
Study type: Interventional

Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA). Secondary objectives: To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared to placebo in combination with TCS. To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.

NCT ID: NCT03761368 Completed - Clinical trials for Remote Ischemic Preconditioning

Remote Ischemic Preconditioning and Contrast Induced - Acute Kidney Injury in Patients Undergoing Elective PCI

Start date: March 1, 2015
Phase: N/A
Study type: Interventional

Prospective, randomized, sham-controlled clinical study was conducted to assess whether RIPC reduces the incidence of CI-AKI measured standard way of using SCr concentration but also with the use of serum NGAL as a new potential biomarker of kidney injury. Furthermore, the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective coronary angiography (CA) followed by percutaneous coronary intervention (PCI).

NCT ID: NCT03761355 Completed - Mindfulness Clinical Trials

Mindfulness and Executive Functions for Prediction of Non-technical Skills of Students in Pediatric Medical Simulations

MindExSim
Start date: October 1, 2018
Phase:
Study type: Observational

Medical simulation is a technique that creates a situation or environment to allow persons to experience a representation of a real event for the purpose of practice, learning, evaluation, testing or to gain understanding of systems or human actions Non-technical skills in pediatric simulation are the skills of communication, leadership, teamwork, situational awareness, decision-making, resource management, safe practice, adverse event minimization, and professionalism, also known as teamwork skills. Mindfulness is the self-regulation of attention with an attitude of curiosity, openness and acceptance. Executive functions include a collection of interrelated functions that are responsible for purposeful, goal-directed, problem-solving behavior. In this project, the investigators aim to check whether features of mindfulness and executive functions can be used to predict teamwork skills of medical students during repeated high-fidelity simulations in emergency pediatric care. The project will include simulation center in Bialystok, Poland. The investigators will conduct this project over a time of 2 years. Team project is made up of 5 persons, including psychologist, simulation instructors and pediatricians. Participants will be students of medical faculty in medical university. The investigators expect to include at least 340 students in the study which will result in 180 assessed as main or second leaders in repeated simulations. Team project will assess the students during high-fidelity pediatric emergency simulations. Methods of assessment of medical students during pediatric emergency simulations: features of mindfulness (Mindful Attention Awareness Scale), assessment of executive functions (The Behavior Rating Inventory of Executive Functions - Adult), non-technical skills (Ottawa Crisis Resource Management scale & checklist), technical skills (checklists) and stress. The researchers first will examine association between mindfulness or executive functions and demographic variables. And finally team project will assess the possibility of prediction of non-technical performance level during medical simulations with the use of mindfulness and executive functions assessment. In general the investigators anticipate that the results of the study will lead to the better understanding of mechanisms that influence non-technical skills in medical students during pediatric emergency cases.

NCT ID: NCT03761199 Completed - Quality of Life Clinical Trials

Assessment of the Impact of Whole Body Cryostimulation on Skin Physiological Indicators

Start date: November 26, 2018
Phase: N/A
Study type: Interventional

The aim of the planned study will be to evaluate the effect of repeated cryostimulation treatments on immunological, morphological, and biochemical indicators of the peripheral blood of patients with atopic dermatitis (AD). The aim of the study will be also to measure the oiling, hydration and pH of the skin of patients with AD after a series of treatments in a cryogenic chamber. Each participant will complete a Brief Questionnaire on Quality of Life, Life Satisfaction Index, Self Evaluation Questionnare and DERMATOLOGY LIFE QUALITY INDEX (before and after the WBC procedures).