This is a Phase 1, randomized, open-label, dose-escalation study to examine the safety, tolerability, and immune response of three doses (6 mcg, 30 mcg, and 60 mcg) of the WEVEE vaccine (VRC-WEVVLP073-00-VP) alone or with alum adjuvant (VRC-GENMIX083-AL-VP) in a 2-product administration
This will be a double-blind, 3-arm, randomized controlled trial with a treatment 1: treatment 2: control allocation ratio of 1:1:1. Primary outcomes of interest are opioid requirements and pain scores over initial 72 hours of the postoperative period. Opioid requirements will be assessed by
Alcohol use disorder is a common comorbidity among trauma patients. This pre-existing condition is associated with Alcohol Withdrawal Syndrome (AWS) and frequently complicates the management of this patient population. Current treatment and/or prevention of AWS includes the administration of
Sevoflurane is an inhalational agent widely used in general anesthesia, both for induction and maintenance of anesthesia. It is not irritative on the airways and has a pleasant smell. Within their properties are: low partition coefficient blood / gas (rapid induction and awakening), low heart, liver
BACKGROUND
Obsessive‐Compulsive Disorder [OCD] is a psychiatric disorder with a lifetime prevalence of 2% which is mainly characterized by obsessional ideas and compulsive behaviours and rituals. Many patients show improvement under cognitive behavioural and/or pharmacological treatment. A minority
Study design This was a randomised, double-blind, placebo-controlled clinical trial among children with a presumptive diagnosis of acute migraine in the ED. The study was approved by the institutional IRB and written informed assent and consent were obtained by the patient and a parent respectively,
Participants were randomized to either receive 3 injections of CYD dengue vaccine or a placebo at 0, 6, and 12 months.
A subset of participants from each country were also evaluated for reactogenicity and immunogenicity.
Participants who consented to participate in the SEP were actively followed for
LANGUAGE-BASED LEARNING SKILLS AND ADHD: IMPACT OF TREATMENT WITH SUSTAINED-RELEASE GUANFACINE
Background:
Children with attention-deficit/hyperactivity disorder (ADHD) often do poorly in school (1,2,3). Their slow academic progress is typically attributable to inattention, restlessness,
Participants (both cohort 1 and 2) received 3 injections of CYD dengue vaccine. Participants (Cohort 1) received rabies vaccine at Month 0 and placebo at 6 and 12 months. Participants (cohort 2) received placebo at 0, 6, and 12 months.
Dengue cases were collected for assessment of efficacy during
Restless legs syndrome (RLS) is a medical condition in which there is an almost irresistible urge to move the legs in response to uncomfortable, difficult-to-describe leg sensations that are usually worse in the evening and especially noticeable when inactive such as sitting in a chair watching TV
Specific Aims:
This study is a six-week, open label trial of the novel antipsychotic agent, ziprasidone, added to a stable dose of clozapine or olanzapine in 40 diabetes mellitus patients, patients with an impaired fasting glucose or insulin resistance with schizophrenia or schizoaffective
Altitude affects human health and well being through its effect on tissue oxygenation by altering the partial pressure of oxygen in the gas that enters the lungs. The partial pressure of any component of a mixed gas is equal to the total pressure of the gas multiplied by the fraction of the gas that
Study Design: Fifteen patients with DSM-IV diagnoses of Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS) will be enrolled in this 12-week open-label study. Parents of potential subjects will do a preliminary phone screen, followed by a clinical
After obtaining consent, patients will enter a two week stabilization phase followed by a 14 week treatment phase. The treatment phase begins with a 9 session group therapy led by clinic nurses trained in the educational model of the American Cancer Association. Subjects will begin the double-blind,
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