Annals of the New York Academy of Sciences
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Ann. N. Y. Acad. Sci. · Jan 2014
Randomized Controlled TrialIntegrating nutrition and early child-development interventions among infants and preschoolers in rural India.
This article describes the development, design, and implementation of an integrated randomized double-masked placebo-controlled trial (Project Grow Smart) that examines how home/preschool fortification with multiple micronutrient powder (MNP) combined with an early child-development intervention affects child development, growth, and micronutrient status among infants and preschoolers in rural India. The 1-year trial has an infant phase (enrollment age: 6-12 months) and a preschool phase (enrollment age: 36-48 months). Infants are individually randomized into one of four groups: placebo, placebo plus early learning, MNP alone, and MNP plus early learning (integrated intervention), conducted through home visits. ⋯ The evaluation examines whether the effects of the MNP intervention vary by the quality of the early learning opportunities and communication within the AWCs. Study outcomes include child development, growth, and micronutrient status. Lessons learned during the development, design, and implementation of the integrated trial can be used to guide large-scale policy and programs designed to promote the developmental, educational, and economic potential of children in developing countries.
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Ann. N. Y. Acad. Sci. · Dec 2004
Randomized Controlled Trial Comparative Study Clinical TrialSubarachnoid analgesia in advanced labor: a comparison of subarachnoid analgesia and pudendal block in advanced labor: analgesic quality and obstetric outcome.
Pain control during labor is a primary objective of antalgic therapy. The use of the peridural as an elective procedure for labor analgesia is now corroborated by the international scientific community. Sometimes a combined spinal-peridural procedure is used together with the intrathecal administration of opioids to also cover the first stage of labor. ⋯ In Group P, however, 10 minutes after placement of the pudendal nerve block, 40 patients reported no improvement in pain symptomatology during contractions and only 16 reported less painful contractions (P < 0.0001). The duration of spinal analgesia (128 +/- 38 minutes) was enough in most cases for delivery to be completed. These results suggest that low-dose bupivacaine-fentanyl spinal analgesia represents an important option for pain relief in late labor, not the least because the procedure does not upset the dynamics of delivery or alter vital parameters and is welcomed by women in labor who are still able to collaborate actively in the birth of their baby.
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Ann. N. Y. Acad. Sci. · Jan 1999
Randomized Controlled Trial Clinical TrialA double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics of CP-101,606 in patients with a mild or moderate traumatic brain injury.
CP-101,606 is a postsynaptic antagonist of the glutamate-mediated NR2B subunit of the N-methyl-D-aspartate (NMDA) receptor. When administered intravenously (i.v.) at the time of injury, CP-101,606 is neuroprotective in animal models of traumatic brain injury (TBI) and ischemia. Minimal adverse effects have been observed in normal human volunteers given i.v. doses of up to 3 mg/kg/hr for 72 hours. ⋯ A Neurobehavioral Rating Scale, used to detect personality changes and behavioral disturbances, indicated that all subjects showed an improvement from their postinjury, predosing baseline but did not significantly differ from each other with respect to type of head injury and/or treatment with drug or placebo. Modified Kurtzke Scoring also showed a similar pattern of improvement irrespective of type of head injury or drug/placebo treatment. This study suggests that CP-101,606, infused for up to 72 hours has no psychotropic effects and is well-tolerated in patients who have sustained a mild or moderate TBI or hemorrhagic stroke.
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Ann. N. Y. Acad. Sci. · Oct 1977
Randomized Controlled Trial Clinical TrialHypnosis, suggestions, and altered states of consciousness: experimental evaluation of the new cognitive-behavioral theory and the traditional trance-state theory of "hypnosis".
Sixty-six subjects were tested on a new scale for evaluating "hypnotic-like" experiences (The Creative Imagination Scale), which includes ten standardized test-suggestions (e.g. suggestions for arm heaviness, finger anesthesia, time distortion, and age regression). The subjects were randomly assigned to one of three treatment groups (Think-With Instructions, trance induction, and Control), with 22 subjects to each group. The new Cognitive-Behavioral Theory predicted that subjects exposed to preliminary instructions designed to demonstrate how to think and imagine along with the suggested themes (Think-With Instructions) would be more responsive to test-suggestions for anesthesia, time distortion, age regression, and so on, than subjects exposed to a trance-induction procedure. ⋯ The results thus supported the new Cognitive-Behavioral Theory and contradicted the traditional Trance State Theory of hypnosis. Two recent experiments, by De Stefano and by Katz, confirmed the above experimental results and offered further support for the Cognitive-Behavioral Theory. In both recent experiments, subjects randomly assigned to a "Think-With Instructions" treatment were more responsive to test-suggestions than those randomly assigned to a traditional trance-induction treatment.