Demographic diversity of participants in Pfizer sponsored clinical trials in the United States.

The approval of new medicinal agents requires robust efficacy and safety clinical trial data demonstrated to be applicable to population subgroups. Limited data have previously been reported by drug sponsors on the topic of clinical trial diversity. In order to establish a baseline of diversity in our clinical trials that can be used by us and other sponsors, an analysis of clinical trial diversity was conducted covering race, ethnicity, sex, and age. This analysis includes Pfizer interventional clinical trials that initiated enrollment between 2011 through 2020. The data set comprises 213 trials with 103,103 US participants. The analysis demonstrated that overall trial participation of Black or African American individuals was at the US census level (14.3% vs 13.4%), participation of Hispanic or Latino individuals was below US census (15.9% vs 18.5%), and female participation was at US census (51.1% vs 50.8%). The analysis also examined the percentage of trials that achieved racial and ethnic distribution levels at or above census levels. Participant levels above census were achieved in 56.1% of Pfizer trials for Black or African American participants, 51.4% of trials for White participants, 16.0% of trials for Asian participants, 14.2% of trials for Native Hawaiian and Pacific Islander participants, 8.5% of trials for American Indian and Alaska Native participants, and 52.3% of trials for Hispanic or Latino participants. The results presented here provide a baseline upon which we can quantify the impact of our ongoing efforts to improve racial and ethnic diversity in clinical trials.

A 75-Year-Old Woman with COVID-19 Pneumonia and Wellens Syndrome Diagnosed by Electrocardiography.

BACKGROUND There are increasing reports of cardiovascular complications associated with coronavirus disease 2019 (COVID-19) due to infection with severe acute respiratory syndrome coronavirus 2. Wellens syndrome, or left anterior descending T-wave syndrome, is diagnosed by a pattern of electrocardiographic (ECG) changes that include inverted or biphasic T waves in leads V2-V3. CASE REPORT A 75-year-old woman presented to the emergency department with a 1-week history of fatigue and progressive shortness of breath who acutely decompensated, necessitating mechanical ventilator support. Initial lab workup revealed COVID-19 positivity, which was confirmed by repeat testing. A routine ECG obtained during her hospitalization and compared with her baseline revealed diffuse T-wave inversions of her precordial leads, which was highly suggestive of Wellens syndrome. Cardiac enzymes obtained were slightly elevated and an echocardiogram did not demonstrate wall motion abnormalities. The patient was initiated on non-ST segment elevation myocardial infarction protocol with heparin infusion for 48 hours and dual antiplatelet therapy, in addition to beta blockade. Repeat ECGs showed complete resolution of Wellens syndrome shortly after therapy. CONCLUSIONS Although rare, Wellens syndrome is a significant indicator of left anterior descending artery stenosis and is commonly associated with acute medical illness. COVID-19 pneumonia has been associated with many adverse cardiovascular outcomes, with ischemia and arrhythmia becoming increasingly more common. Diagnosis of Wellens often includes coronary angiography; however, during the current pandemic, many authorities have recommended medical management alone during the acute phase of care, depending on the severity of concomitant illness.

West of Ireland facial injury study. Part 2.

The pattern, presentation, and volume of facial injury in the west of Ireland are subjectively different from those in the United Kingdom. We know of no prospective regional study of facial injury in Ireland to date, and nationally there is no system in place to collect data on injury. The epidemiology of facial trauma has important implications for the development of health services, the education and training of clinicians, workforce planning, prevention of injury, and promotion of health. Over 1 week we did a multicentre prospective data collection study involving all emergency departments in the west of Ireland. All patients who attended with facial injuries were included (n=325), and those with injuries solely of the scalp and neck were excluded. The proforma recorded a patient's characteristics, details of injury and presentation, treatment and follow-up. It also included relation with sport, alcohol, assault, and animals. Eighty-two fractures were suspected, of which 46% were nasal. Accidents caused 75% of injuries and sport caused 27%. Fractures were sustained by 63% (n=5) of those wearing helmets while playing hurling, but by only 22% of those who were not. Helmets did, however, reduce the total number of injuries. Injuries were associated with alcohol (23%), assault (14%), falls (38%), and motor vehicle crashes (11%). Because of the differences in aetiology, different avenues and methods are required to prevent injury. Staff in emergency departments will need training in this area, given the large proportion of facial trauma in the region.

Oral cavity examination: beyond the core curriculum?

There has been little improvement in the survival of patients with oral cancer despite advances in treatment, and late presentation of the disease is one reason for this poor outcome. Research and experience tell us that tuition in medical schools about examination of the oral cavity is poor. We aimed to ascertain the opinions and experience of students regarding this in our institution by dissemination of a web-based anonymous questionnaire that focused on education about examination of the oral cavity and experience in carrying it out. From a cohort of 600 students 458 (76%) responded. A total of 334 (73%) had not been taught how to examine the oral cavity, 372 (81%) had had no experience of doing so in patients, and only 13/86 (15%) felt confident to diagnose a carcinoma of the lip or oral cavity. Eighty-nine percent felt that the tuition given had not been adequate. Examination of the oral cavity cannot be considered part of the core clinical curriculum, and medical schools and departments of oral and maxillofacial surgery urgently need to embrace the introduction of the necessary skills.

Electronic follow-up of facial lacerations in the emergency department.

It is often difficult for emergency department staff to follow up the primary closure of simple facial lacerations. This is important to allow closure of the feedback loop. Consecutive patients who were sutured by a single operator using the same technique were asked to send a photograph of the laceration six months and 12 months afterwards. The patients had Internet access and a digital camera, or a mobile phone with a camera. They were given a leaflet with the details of the email address or mobile number to send the picture to. A reminder telephone call was made to each patient at six months and 12 months, and the email address or mobile number to send the picture to was given again. In each telephone call patients were asked to grade the healing on a 5-point scale from 1 = very happy to 5 = very unhappy. At 13 months all patients were re-contacted and reminded again. Fifty patients were included in the study (33 males). The cause of injury was sport in 17 patients, assault in 18 and accidents in 15. At six months, 23 patients stated that they were happy and 27 were very happy with the scar. The mean score was 1.5. At 12 and 13 months, four patients were happy and 46 very happy. The mean score was 1.1. Twenty-four patients said they would use a computer/camera to send in the follow-up image, and 26 patients had a mobile phone with a camera and said they would use that. Despite the reminders, no patients sent a photograph. The results provide no evidence to support the use of photographs sent by email or text message for the follow-up of facial lacerations sutured in the emergency department.

Effect of Red Bull energy drink on cardiovascular and renal function.

Energy drink consumption has been anecdotally linked to the development of adverse cardiovascular effects in consumers, although clinical trials to support this link are lacking. The effects of Red Bull energy drink on cardiovascular and neurologic functions were examined in college-aged students enrolled at Winona State University. In a double-blind experiment where normal calorie and low calorie Red Bull were compared to normal and low calorie placebos, no changes in overall cardiovascular function nor blood glucose (mg/dL) were recorded in any participant (n = 68) throughout a 2-h test period. However, in the second experiment, nine male and twelve female participants subjected to a cold pressor test (CPT) before and after Red Bull consumption showed a significant increase in blood sugar levels pre- and post Red Bull consumption. There was a significant increase in diastolic blood pressure of the male volunteers immediately after submersion of the hand in the 5 degrees C water for the CPT. Under the influence of Red Bull, the increase in diastolic pressure for the male participants during the CPT was negated. There were no significant changes in the blood pressure of the female participants for the CPT with or without Red Bull. Finally, the CPT was used to evaluate pain threshold and pain tolerance before and after Red Bull consumption. Red Bull consumption was associated with a significant increase in pain tolerance in all participants. These findings suggest that Red Bull consumption ameliorates changes in blood pressure during stressful experiences and increases the participants' pain tolerance.

Evaluation of breath biomarkers and serum haptoglobin concentration for diagnosis of bovine respiratory disease in heifers newly arrived at a feedlot.

OBJECTIVE: To evaluate exhaled N(2)O (eN(2)O), exhaled CO (eCO), and serum haptoglobin concentrations as diagnostic criteria for bovine respiratory disease (BRD) and determine whether a combination of biomarkers would be useful for predicting health outcomes of heifer calves. ANIMALS: 337 heifer calves newly arrived at a feedlot. PROCEDURES: Body weights, serum haptoglobin concentrations, and rumen temperatures were determined. Calves (n = 183) were randomly selected for breath sampling. Variables were compared among calves that remained healthy and those requiring treatment. RESULTS: Body weight at the time of first and second antimicrobial treatments did not differ from that at arrival, whereas body weight at the time of third antimicrobial treatment was lower. Temperature was lower at arrival, compared with that during antimicrobial treatment. Ratio of eN(2)O:eCO(2) was lowest at arrival, intermediate at the first and second antimicrobial treatments, and greatest at the third antimicrobial treatment. Ratio of eCO:eCO(2) was greater at times of antimicrobial treatment, compared with arrival. Concentration of serum haptoglobin was greatest at the time of the first antimicrobial treatment, lowest at the times of second and third treatments, and intermediate at arrival. Arrival ratios of eN(2)O: eCO(2) and eCO:eCO(2) and concentration of haptoglobin did not differ among heifers subsequently treated 1, 2, or 3 times. CONCLUSIONS AND CLINICAL RELEVANCE: Although breath analysis was successfully implemented in a research feedlot, arrival rumen temperature, eN(2)O, eCO, and haptoglobin concentration were not accurate in predicting occurrence of BRD during a preconditioning program. However, these biomarkers might support the diagnosis of BRD.

Measurement of acetaldehyde in exhaled breath using a laser absorption spectrometer.

A high-resolution liquid-nitrogen-free mid-infrared tunable diode laser absorption spectroscopy (TDLAS) system was used to perform real-time measurement of acetaldehyde concentrations in human exhaled breath following ingestion of an alcoholic beverage. Acetaldehyde absorption features were measured near 5.79 mum (1727 cm(-1)) using a IV-VI semiconductor laser, a 100 m long path optical gas cell, and second- harmonic detection coupled with wavelength modulation. Acetaldehyde levels were measured with a minimum detection limit of 80 ppb for 5 s integration time. The variations in exhaled acetaldehyde levels over time were analyzed prior to and following ingestion of two different amounts of white wine. A method to calibrate acetaldehyde measurements internally using water vapor absorption lines was investigated to eliminate the need for system calibration with gas standards. The potential of a TDLAS system to be used as a noninvasive clinical tool for measurements of large volatile compounds with possible applications in cancer detection is demonstrated.

Specific detection of gaseous NO and 15NO in the headspace from liquid-phase reactions involving NO-generating organic, inorganic, and biochemical samples using a mid-infrared laser.

Nitric oxide (NO) is an important biological signaling agent. The specific detection of NO represents a continuing challenge in the field of NO research. Many methods are currently employed for the detection of NO. Here, we report a qualitative but specific detection method for gaseous NO liberated in and from solution taking advantage of its low solubility. Importantly, our mid-infrared laser absorption method does not depend on any chemical derivatization of NO, and is applicable over a wide range of concentrations for both protein work and in organic-inorganic modeling work. We also apply this method to the specific detection of 15NO.

Training in oral disease, diagnosis and treatment for medical students and doctors in the United Kingdom.

To find out if the training of medical undergraduates and qualified doctors was adequate to diagnose, investigate, manage, and refer common oral disorders appropriately, we sent anonymous questionnaires to undergraduate and postgraduate medical and dental deans, accident and emergency (A&E) doctors, and dentists. We wanted to know if they were capable of diagnosing and treating 10 common oral disorders, and if their training was adequate to enable them to do so. Ten clinical photographs with short clinical histories were sent to 48 A&E physicians together with a structured questionnaire. Twenty-one of the 29 medical schools in the UK responded to a questionnaire about the teaching given in the current curriculum about oral anatomy and pathology, and the prevention of oral disease. A questionnaire sent to the deans of the 16 British dental schools asked how many academic staff were involved in undergraduate teaching, and how many in postgraduate courses. A third questionnaire was sent to the 24 postgraduate medical deans to find out how many postgraduate courses there were for qualified medical staff. Of the 48 medical staff, 134 (28%) diagnosed cases correctly, compared with 194 (88.7%) of the 22 dentists, indicating serious deficiencies in diagnostic awareness. Only 11 of the 21 medical schools who responded currently incorporate teaching of oral pathology in their curricula. We conclude that doctors and medical students are inadequately educated about oral diseases with obvious consequences.

Nitric oxide breath testing by tunable-diode laser absorption spectroscopy: application in monitoring respiratory inflammation.

We used a high-resolution mid-IR tunable-laser absorption spectroscopy (TLAS) system with a single IV-VI laser operating near 5.2 microm to measure the level of exhaled nitric oxide (eNO) in human breath. A method of internal calibration using simultaneous eNO and exhaled CO2 measurements eliminated the need for system calibration with gas standards. The results observed from internally calibrating the instrument for eNO measurements were compared with measurements of eNO calibrated to gas standards and were found to be similar. Various parameters of the TLAS system for eNO breath testing were examined and include gas cell pressure, exhalation time, and ambient NO concentrations. A reduction in eNO from elevated concentrations (approximately 44 parts in 10(9)) to near-normal levels (<20 parts in 10(9)) from an asthmatic patient was observed after the patient had received treatment with an inhaled glucocorticoid anti-inflammatory medication. Such measurements can help in evaluating airway inflammation and in monitoring the effectiveness of anti-inflammatory therapies.