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NCT ID: NCT03400267 Completed - STEMI Clinical Trials

The Effect of Opioids on P2Y12 Receptor Inhibition in Patients With ST-Elevation Myocardial Infarction Who Are Pre-treated With Crushed Ticagrelor

ON-TIME 3
Start date: February 16, 2018
Phase: Phase 4
Study type: Interventional

Fast and accurate platelet inhibition is an important therapeutic goal in the acute treatment of patients with ST-segment elevation myocardial infarction (STEMI). Platelet inhibitory effects induced by normal oral P2Y12 receptor antagonists, for example ticagrelor, are delayed in STEMI patients undergoing primary percutaneous coronary intervention (primary PCI), which may be attributed to impaired absorption affecting drug pharmacokinetics (PK) and pharmacodynamics (PD). Another therapeutic goal in the acute treatment of STEMI is reduction of sympathetic stress and catecholamine release, thereby improving the balance between the demand for and supply of oxygen, by analgesia like fentanyl of morphine. To date, there are no studies that have specifically assessed the pharmacodynamics influences of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor tablets. Therefore, In the ON-TIME-3 study, the investigators seek to show the influence of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor in the ambulance.

NCT ID: NCT03400111 Completed - Clinical trials for Orthodontic Appliance Complication

The Role of Paracetamol-caffeine and Laser Irradiation on Controlling Pain and Discomfort During Orthodontic Treatment

Start date: September 15, 2017
Phase: N/A
Study type: Interventional

Patients with class I malocclusion who have mild to moderate crowding will be treated in this study. The efficacy of low level laser therapy and Panadol-extra® in relieving pain due to orthodontic treatment will be assessed. The effect of these two interventions on oral-health related quality of life during all stages of orthodontic treatment will be explored, i.e. at the following stages: (1) separation between teeth, (2) archwire changing, (3) bonding of brackets, (4) removal of the fixed appliances. There are three groups : 1. a group of patient being irradiated with low-level laser therapy (LLLT) at specific time points to relieve pain and discomfort. 2. a group of patient in which pain control will be accomplished by prescribing Panadol Extra tablets in a regular manner. 3. a group of patients in which nothing will be given to them during the course of treatment.

NCT ID: NCT03399981 Completed - Clinical trials for Progressive Multifocal Leukoencephalopathy

Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries

Start date: June 1, 2017
Phase:
Study type: Observational

The primary purpose of this study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) among patients who switched to Tysabri from disease modifying therapies (DMTs), including newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate). Researchers will also look to estimate the incidence of other serious opportunistic infections among patients who switch to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate)

NCT ID: NCT03399786 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Start date: January 18, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial hypercholesterolemia (HoFH). The secondary objectives of the study are to evaluate the effect of evinacumab IV on other lipid parameters, evaluate the effect of evinacumab on LDL-C goal attainment, assess the effect of evinacumab on eligibility for apheresis (using German and US apheresis criteria), evaluate the safety and tolerability of evinacumab in patients with HoFH, assess the pharmacokinetics (PK) of evinacumab in patients with HoFH and evaluate the potential development of anti-evinacumab antibodies.

NCT ID: NCT03399760 Completed - Clinical trials for Malocclusion, Angle Class II, Division 1

Efficacy of Injectable Platelet Rich Fibrin (i-PRF) in Enhancing Bone Quality

Start date: August 20, 2017
Phase: N/A
Study type: Interventional

Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines, will be divided randomly into two groups, and will randomly assigned to one side of the maxillary arch at the first premolar region, and the other side served as the control. Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side. Soldered transpalatal arch will be used as an anchor unit. The dento-alveolar changes will be assessed immediately before retraction and after 6 months using CBCT.

NCT ID: NCT03399422 Completed - Clinical trials for Malocclusion, Angle Class II, Division 1

Efficacy of Biological Technique in Upper Canine Retraction and Levels of Discomfort

Start date: August 20, 2017
Phase: N/A
Study type: Interventional

Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines, will be divided randomly into two groups, and will randomly assigned to one side of the maxillary arch at the first premolar region , and the other side served as the control. canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side , soldered transpalatal arch will be used as an anchor unit. Pre- and post distalization dental casts will be evaluated to study rate of canine distalization, over a follow-up period until a Class I canine relationship will be achieved. The levels of Pain and discomfort will be monitored using a questionnaire with a VAS scale administered three times during the first day after prf injection.

NCT ID: NCT03399058 Completed - Clinical trials for Underweight Children Aged 6-23 Month Old (WAZ < -1)

Innovative Nutrition and mHealth Evidence Building Project

Start date: November 27, 2017
Phase: N/A
Study type: Interventional

The project is the collaboration with the lead agencies National Institute of Public Health, World Vision and Emory University World Vision has a history of successfully implementing "Positive Deviance/Hearth (PDH)" programs across the globe. PDH is a community-based intervention utilizing locally appropriate health and infant feeding practices to rehabilitate underweight children and promote behavioral changes in caregivers. A recent systematic review on the PD/Hearth approach found that although some programs show clear success in particular settings, overall, the results were mixed for program effectiveness. Furthermore, with the growing use of mobile phones and technology in the world, including Cambodia, there have been various studies and a systematic review that found SMS reminders and voice recordings to have promising impact on behavior change of patients for smoking cessation and improved adherence to drugs for asthma patients. Although there are positive findings around the use of mobile devices to improve behavior change, there has yet to be a study that examines the impact of mobile phones on improving behavior change of caregivers related to nutrition, water, sanitation and hygiene (WASH), health, and caring practices, which as a result, would decrease the prevalence of underweight in children 6-23 months of age. This study will provide evidence on the effectiveness of the PDH model in Cambodia compared to the current standard of care. Investigators believe the PDH approach will be a powerful tool to reduce child malnutrition. In addition, given the intensity and cost burden associated with PDH, investigators will simultaneously test if the intensity of the PDH model can be reduced by introducing an innovative application of mHealth to replace 50% of face-to-face education sessions (5 days) and all follow up visits with mobile support calls. Collectively this research will provide critical data to inform program operations on the optimal and most effective method to reduce child underweight in Cambodia. In Year 1, the purpose of this study is to assess the effectiveness of contextualized messages through PDH programs and a mobile technology (mHealth), to improve knowledge, behaviour change, and level of confidence of caregivers with underweight children aged 6-23 months in feeding, hygiene, health-seeking, and caring practices. In Year 2, the study's aim will be to assess the prevention of underweight in the siblings of the children included in the three programs outside of the 360 study subjects from Year 1.

NCT ID: NCT03398889 Completed - Renal Function Clinical Trials

Intestinal Microbiome and Extremes of Atherosclerosis

Start date: July 1, 2014
Phase: N/A
Study type: Observational

Patients attending stroke prevention clinics and a premature atherosclerosis clinic at University Hospital in London, ON, Canada were recruited to the study. They completed a dietary questionnaire, provided stool samples and had blood drawn to measure plasma levels of metabolites produced by the intestinal bacteria.

NCT ID: NCT03398655 Completed - Clinical trials for Recurrent Platinum Resistant Ovarian Cancer

A Study of VB-111 With Paclitaxel vs Paclitaxel for Treatment of Recurrent Platinum-Resistant Ovarian Cancer (OVAL)

OVAL
Start date: December 19, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this phase 3, randomized, multicenter study is to compare VB-111 and paclitaxel to placebo and paclitaxel in adult patients with Recurrent Platinum-Resistant Ovarian Cancer.

NCT ID: NCT03398421 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib

Start date: January 17, 2018
Phase: Phase 1
Study type: Interventional

Nemiralisib is a potent anti-inflammatory agent for the treatment of chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases. The Cytochrome P450 3A4 (CYP3A4) is a major route of clearance for nemiralisib. The co-administration of drug therapies, which modulate CYP3A4, may alter the exposure of nemiralisib. Hence, this clinical drug interaction study with itraconazole (a potent CYP3A4 inhibitor) is required. The study will evaluate the PK, safety and tolerability of nemiralisib when administered alone and when administered concomitantly with repeat doses of itraconazole in healthy males and females. Subjects will receive treatment with nemiralisib alone in Period 1 and itraconazole followed by nemiralisib in Period 2 in single sequence crossover manner. Approximately 20 subjects will be enrolled such that approximately 16 evaluable subjects complete the study. Each subject will participate in the study for approximately 7 weeks including screening visit, 2 treatment periods and a follow up visit.