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Filter by:The primary safety objectives were: - Part 1: To determine the safety and tolerability of single doses of ZP-059 in healthy subjects - Part 2: To determine the safety and tolerability of multiple doses of ZP-059 in subjects with mild stable asthma - Part 3: To determine the safety and tolerability of single doses of ZP-059 in subjects with mild to moderate stable asthma. The primary PK objectives were: - Part 1: To characterize systemic PK of voriconazole and N-oxide voriconazole after single doses of ZP-059 in healthy subjects - Part 2: To characterize systemic PK of voriconazole and N-oxide voriconazole after multiple doses of ZP-059 in subjects with mild stable asthma - Part 3: To characterize systemic PK of voriconazole and N-oxide voriconazole after single doses of ZP-059 and single doses of oral voriconazole in subjects with mild to moderate stable asthma.
This is a 3-week open label, one group study to determine the agreement between the pharmacological treatment recommended by TDApp1 and the interventions recommended by relevant clinical practice guidelines.
This phase Ib trial studies the side effects of infigratinib before surgery in treating patients with upper tract urothelial cancer. Infigratinib may stop the growth of tumor cells by blocking the activities of a gene called FGFR needed for cell growth. Giving infigratinib before surgery may cause the tumor to shrink, which may make the surgical procedure easier and/or reduce the need for more extensive surgery.
The main objective will be to compare the number of ventilator-free days within the 28 days following the first spontaneous breathing trial between strategies of extubation performing spontaneous breathing trials with T-piece trials or with Pressure-Support trials. To do that, the study director proposed to conduct a prospective multicenter randomized controlled open-label trial comparing these 2 strategies of weaning in patients at high-risk of extubation failure in the Intensive Care Unit. Patients included will be randomized before performing the first spontaneous breathing trial and will be assigned to one of the following two groups according to the weaning strategy: T-piece trial group or Pressure-Support trial group.
Direct muscle stimulation (DMS) method is one of the electrodiagnostic methods used in the diagnosis of critical illness myopathy (CIM) and critical illness neuropathy (CIN). The ratio of amplitude of compound muscle action potential (CMAP) obtained by nerve stimulation (nCMAP) to amplitude of CMAP obtained by DMS (dmCMAP) can be used to differentiate these two diseases. Although not certain, if the ratio is < 0.5, the diagnosis is thought to be consistent with CIN. The ratio > 0.5 is considered to be a finding supporting CIM. The investigators aimed to find the reference values of the ratio from healthy individuals. A monopolar needle electrode was used for DMS. The dmCMAP and nCMAP were recorded with a concentric needle. The ratio was calculated by using amplitudes of dmCMAP and nCMAP obtained from deltoid and tibialis anterior muscles.
This study evaluates an investigational vaccine designed to protect humans against infection with respiratory syncytial virus (RSV). The investigational vaccine (MV-012-968) is administered as drops in the nose. This study specifically analyzes the safety of, and the immune response to, the vaccine when administered to healthy non-pregnant adults between the ages of 18 and 40 years.
To confirm the predictors based on patient specific characteristics and ovarian response and develop dosing chart when Follitrope™ PFS is administered to infertility women patients.
The purpose of this trial is to evaluate safety and efficacy of surgical application of EB-101 (autologous, gene-corrected keratinocyte sheets) as a treatment of recessive dystrophic epidermolysis bullosa (RDEB).
This randomized, two‐armed, placebo-controlled, cross-over, controlled trial aimed to evaluate the effect of virtual reality exposure therapy (VRET) on dental anxiety, pain, and behaviour among children undergoing dental treatment under local anaesthesia. The null hypotheses were as follows: VRET has no effect on reducing dental anxiety and dental pain scores of participants; and there is no difference between subjective and objective measure scores of dental anxiety and pain when VRET and attention palcebo-controlled (APC) groups are used to reduce anxiety in children undergoing dental treatment with local anaesthesia.
Single-use medical instruments are intended by the manufacturers for single-use only or for single-patient-use only. Nevertheless, single-use instruments are being reused more than once in many countries around the world. The reasons are mainly economic in developing countries and environmental in developed countries. Concerns are being raised regarding reused instruments sterility and efficacy. Since there is paucity of evidence on safety of multiple use of single-use instruments in surgery, we decided to conduct a clinical study comparing the same surgical procedure performed with new versus reused surgical instrument. We decided to study laparoscopic appendectomy which is a simple and the most common emergency surgery. Instrument under the scrutiny is ultrasonic scalpel which uses high-frequency ultrasound vibration for coagulating and cutting tissue. In the studied period of time, all eligible patients with acute appendicitis will be randomized in two groups, first having surgery with new device and the second having surgery with reused device. Removed appendix will be analyzed for lateral thermal damage and the patients will be followed-up for one month for potential differences in clinical outcomes like pain-killers consumption, length of stay and postoperative complications.