Body Temperature Sample Clauses
Body Temperature. MDMA administered in a controlled setting produces only a slight increase in body temperature [96], and ambient temperature does not enhance or attenuate this slight elevation in humans. If temperature rises more than 1° C, attempts will be made to lower it by removing blankets and layers of clothing, decreasing the ambient temperature and, if necessary, directing a fan toward the participant. If at any time the temperature rises more than 1.5° C above baseline despite these efforts, the study physician will be consulted for further evaluation and treatment.
Body Temperature. Examination of head, eyes, ears, nose, throat, skin, heart, lungs, abdomen and extremities. • Brief neurological exam (cranial nerves 2-12, sensory, motor, reflexes and cerebellar function). • Electrocardiogram (ECG). • Serum electrolytes, metabolic profile, urinalysis and complete blood count • Thyroid stimulating hormone (TSH), free T3, and free T4. • Human Immunodeficiency Virus (HIV) serology. • Urine-dip pregnancy test on females with childbearing potential. • Urinary drug test. • C-SSRS to assess past and current suicide risk. Results of HIV serology will be kept confidential, and appropriate referral for counseling may be necessary in accordance with local law. The clinical laboratory values will not be captured in the CRF, but will be used to establish eligibility and will be kept with the subject’s source record. Clinically significant abnormal values will be captured as medical history in the CRF. If, upon examination, there are questions raised about possible medical problems, the PI will request a review of subject medical records and request additional tests or assessments as indicated. A blinded Independent Rater who will not be present during any of the therapy sessions will administer: • Structured Clinical Interview for Diagnoses I Research Version (SCID-I-RV) to assess eligibility based on Axis I diagnoses, which includes a self-report questionnaire to focus on modules to use based on symptoms. • CAPS to assess PTSD symptoms and eligibility, which may be recorded to video in as many instances as necessary to establish inter-rater reliability. • GAF to assess general psychological function. • PASAT to assess cognitive function. • RBANS to assess cognitive function. The subject will complete the following self-report measures: • PTGI (in reference to time since the trauma) • PDS to assess self-reported PTSD symptoms • BDI-II to assess depression symptoms • NEO-PI to assess changes in personality • PSQI to assess changes in sleep quality • DES-II to assess dissociation symptoms