Kornimate/medical-research-clean huggingface dataset:
a study of auxora in patients with critical covid-19 pneumonia

Conditions: Pneumonia

Summary: this is a single-blind study consisting of up to 3 cohorts patients will be randomized 3:1 to auxora or placebo. the first 4 patients will be enrolled in cohort 1. if dose escalation occurs, the next 4 patients will be enrolled in cohort 2 if dose escalation occurs, the next 8 patients will be enrolled in cohort 3. the decision to escalate dosing will be made by calcimedica in consultation with the pi and after the review of safety events in cohorts 1 and 2.


Eligibility criteria:
inclusion criteria: 1. has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen; 2. moderate ards characterized by the following criteria: * invasive mechanical ventilation with a minimum peep of 5 cm h2o; * pao2/fio2 ≤200 that may be estimated from pulse oximetry or determined by arterial blood gas; * no evidence of volume overload or heart failure; 3. the patient is ≥18 years of age at the time of consent; 4. qtcf interval ≤ 440 milliseconds; 5. a female patient of childbearing potential must not attempt to become pregnant for 39 months, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug; 6. a male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 39 months after the last dose of study drug. a male patient must not donate sperm for 39 months; 7. the patient is willing and able to, or has a legal authorized representative (lar) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol. exclusion criteria: 1. expected survival or time to withdrawal of life-sustaining treatments expected to be \<7 days. 2. ecmo; 3. suspected septic shock; 4. the patient has a history of: * organ or hematologic transplant; * hiv; * active hepatitis b or hepatitis c infection; 5. current treatment with: * chemotherapy; * immunosuppressive medications or immunotherapy (see section 5.3 for list of prohibited immunosuppressive medications and immunotherapy) at the time of consent; * hemodialysis or peritoneal dialysis; 6. the patient is known to be pregnant or is nursing; 7. currently participating in another study of an investigational drug or therapeutic medical device at the time of consent; 8. allergy to eggs or any of the excipients in study drug.

Keywords: covid-19 coronavirus pneumonia calcium release-activated calcium channel (crac) inhibitors cm4620 auxora
phase 1 study to evaluate the safety, tolerability, pk, and pd of tvb-3567 in healthy participants with or without acne

Conditions: Acne

Summary: this is a 4-part study. part a will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (sad) to assess the safety, tolerability, pharmacokinetics (pk), and pharmacodynamic (pd) biomarkers of tvb-3567 administered orally in healthy participants. part b will be a randomized, open-label, 2-way crossover investigation to assess the effect of food on a single dose tvb-3567 administered orally in healthy participants. parts c and d will be randomized, double-blind, placebo-controlled investigations of multiple ascending doses (mad) to assess the safety, tolerability, pk, and pd/biomarkers of tvb-3567 administered orally in healthy participants without and with moderate to severe acne, respectively.


Eligibility criteria:
inclusion criteria: healthy participants (parts a, b and c) 1. healthy, adult, male or female 18-55 years of age 2. body mass index (bmi) ≥18.0 and ≤32.0 kg/m2 3. medically healthy with no clinically significant medical history 4. understands the study procedures in the informed consent form (icf) and willing and able to comply with the protocol healthy participants with acne (part d only) participants must meet all of the above criteria, as well as the following inclusion criteria to be eligible for participation in the study: 1. bmi ≥18.0 and ≤37.0 kg/m2. 2. must be diagnosed with moderate to severe acne vulgaris exclusion criteria: healthy participants (parts a, b and c) 1. history or presence of clinically significant medical or psychiatric condition or disease 2. history or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds including over the counter acne products. 3. has a clinically significant ophthalmic examination finding 4. female participant of childbearing potential 5. unable to refrain from or anticipates the use of: * any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements * any topical anti-acne treatment on the face * any drugs known to be moderate or strong inducers of cyp3a4 enzymes, bcrp, and/or p gp, including st. john's wort, beginning 28 days prior to the first dosing. * part c only: any previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all-trans retinoic acid. healthy participants with acne (part d only) participants must not be enrolled if they do not meet any of the above criteria, as well as the following exclusion criteria: 1. unable to refrain from or anticipates the use of: * any previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all trans retinoic acid. * photoelectric therapy, dermabrasion, or chemical peeling * intra-articular and systemic corticosteroid therapy 2. significant skin diseases
genetic epidemiology of change in cvd risk factors

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to extend knowledge of the genetic factors affecting the course of cardiovascular disease risk factor development over a substantial portion of an individual's lifetime.

background: while the onset of symptomatic cardiovascular disease (cvd) typically occurs in middle age or later, the development of the underlying pathology is clearly a long-term process, and early-state lesions having been identified at autopsy even in children. understanding the course of cvd risk development from childhood into middle age will clearly be valuable both in understanding the pathology of cvd and in targeting preventive measures most effectively. furthermore, while genetic factors are agreed to play a significant role in the development of cvd, most genes contributing to interindividual variation in cvd risk will have relatively small effects on risk for any given individual, even though their aggregate effects contribute significantly to cvd risk in the overall population. relatively little is known about the effects of genetic variants on the course of cvd risk factor development in individuals over time. the bogalusa heart study (bhs), which began in 1973 as a study of cvd risk factors in children but evolved to cover the development of cvd risk factors from childhood into early middle age, offers an unparalleled resource for investigating the genetic factors influencing within-individual changes over time in quantitative factors, such as serum lipids and blood pressure, related to cvd risk. design narrative: approximately 1500 individuals who were examined in the bhs on at least three separate occasions over a period of up to 20 years, and who consented to participate in studies of genetic factors influencing cvd risk, will have genotypes measured at selected loci either known or strongly suspected to affect interindividual variation in cvd risk. longitudinal multilevel regression will be used to measure the effects of variation at these loci on quantitative cvd risk factor profiles within individuals and to determine whether some gene effects on cvd risk variation are age-dependent.

Eligibility criteria:
schoolchildren from bogalusa, louisiana. all children in bogalusa public schools were eligible.
concurrent training and metabolic profile, lung function, quality of life and stress

Conditions: Sedentary Lifestyle; Metabolic Disorders; Concurrent Exercise; Lung Function Decreased; Stress; Quality of Life; Office Worker

Summary: physical inactivity and sedentary time are highly prevalent worldwide and are associated with many adverse health outcomes. workers adults spend two-thirds of their workday sitting, so they are particularly at risk. exercise is considered a preventive and treatment tool for diseases, however, the effects of concurrent training (that is, aerobic plus resistance training) are not well established in healthy adults. this research project aims to analyze the effects of a concurrent training program on metabolic profile, lung function, stress and quality of life, as well as body composition and physical fitness in sedentary adults. this is a single-blinded two-arm rct with parallel groups. after completion of baseline assessments, eligible participants will be randomized in a 1:1 ratio to participate in concurrent training group or control group. repeat assessments will be taken immediately post 8 weeks and post 16 weeks of intervention.


Eligibility criteria:
inclusion criteria: * men and women with ages between 40 to 64 years old * physically inactive adults * full-time workers in a sedentary job * bmi between 18 and 35 kg/m2 * maintain the current diet and undergo all testing procedures exclusion criteria: * chronic disease (e.g., diabetes, cardiovascular disease, pulmonary disease) * cognitive impairments and/or psychiatric conditions that could interfere with the study outcomes * take any medication that could interfere with the study outcomes * limitations that prevent them from practicing exercise * history of heart failure/myocardial infarction * uncontrolled or abnormal blood pressure * smokers
retrospective review of anesthetic considerations for pulmonary artery rehabilitation

Conditions: Pulmonary Artery Stenosis; Tetralogy of Fallot; Pulmonary Atresia

Summary: pulmonary artery rehabilitation procedure is done frequently in the catheterization suite for patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for patients with tetralogy of fallot with pulmonary atresia and major aortopulmonary collaterals. considering that the investigators' institution is a major center for treating these cases, the investigators wanted to do a retrospective review of the investigators' data to share the investigators' anesthetic management of these procedures.


Eligibility criteria:
inclusion criteria: * patients who underwent pulmonary artery angioplasty during the period between october 1st 2010 and october 1st 2015 at nch. exclusion criteria: * none
evaluation of the dosing regimen of vancomycin in pediatric patients

Conditions: Gram-Positive Bacterial Infections

Summary: in this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. therefore data will be collected from all pediatric patients hospitalized in university hospitals leuven between january 2012 and april 2014 who were treated with vancomycine.

in this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. therefore data will be collected from all pediatric patients hospitalized in university hospitals leuven between january 2012 and april 2014 who were treated with vancomycine. patient files will be screened for relevant information. individual patients can be included multiple times if vancomycin has been administered more than once.

Eligibility criteria:
inclusion criteria: * pediatric patients hospitalized in the university hospitals leuven between january 2012 and april 2014, treated with vancomycin exclusion criteria: -

Keywords: vancomycin pharmacokinetics trough level pediatric
study evaluating desvenlafaxine succinate sustained release (dvs sr) vs. escitalopram in postmenopausal women

Conditions: Depression; Depressive Disorder; Depressive Disorder, Major

Summary: desvenlafaxine succinate (dvs) is a potent and selective serotonin and norepinephrine reuptake inhibitor (snri). this study will investigate the safety, efficacy, and tolerability of dvs sr versus escitalopram in women with major depressive disorder (mdd) who are postmenopausal.


Eligibility criteria:
inclusion criteria: * postmenopausal women between the ages of 40 and 70 years, inclusive. * a primary diagnosis of mdd, single or recurrent episode, without psychotic features using the modified mini international neuropsychiatric interview (mini). * montgomery-asberg depression rating scale (madrs) total score \> or = 22 at the screening and baseline visit. exclusion criteria: * use of oral estrogen-, progestin-, androgen-, or selective estrogen receptor modulator (serm)-containing drug products 8 weeks before baseline. * current (within 12 months) psychoactive substance abuse or dependence (including alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder. * a history or active presence of clinically important medical disease. additional criteria apply.

Keywords: mdd major depressive disorder depression
molecular studies and clinical correlations in human prostatic disease

Conditions: Prostate Cancer

Summary: the genitourinary oncology/urology services at memorial sloan-kettering cancer center (mskcc) participates in research for the control, treatment, and cure of cancer. the purpose of this study is to collect normal and cancerous tissues, in addition to blood, and other body fluid samples from men with prostate cancer or prostatic disease. these samples may be stored for future use or used immediately by researchers who study prostate cancer and try to find better ways to diagnose, prevent, and treat it. we will look for genetic changes and protein markers on these cells. we hope to learn more about what makes some people get prostate cancer, why some cancers are more aggressive than others, and why some cancers respond to or resist different treatments. we may also try to grow the tumor cells in the lab. we may find a new treatment for prostate cancer based on this research.

the therapeutics program for advanced prostate cancer is based on the hypothesis that the factors contributing to and associated with progression change as the disease evolves. to categorize these changes we now consider the disease as a series of states. 1 the states represent points where an intervention might be considered to prevent cancer from developing, to eliminate established disease, or to delay progression. the states also represent clinically significant milestones that can be used to assess treatment effects.

Eligibility criteria:
inclusion criteria: men with prostate conditions representing the following disease states: * no cancer diagnosis * clinically localized disease * rising psa * clinical metastases: noncastrate * clinical metastases: castrate (testosterone ≤ 50 ng/ml) * signed informed consent exclusion criteria: -patients without any prostate related problems.

Keywords: benign rising psa clinical metastases 90-040
diet, eating, and lifestyle improvement for valued employees and their relatives

Conditions: Diet Habit; Obesity; Food Habits

Summary: food is widely understood as a cornerstone of health, however multiple barriers stand between well-intentioned, well-informed consumers and the adoption of healthier dietary practices. this mixed-methods randomized controlled trial (rct) will measure the impact of offering a community sustained agriculture (csa) share as an employee benefit on household food environments (diets), eating behaviors, and lifestyles.

aim: we will test a strategy to increase frequency of cooking meals at home and consumption of healthful, fresh foods by providing study participants with a csa membership. study design: this is a mixed method randomized controlled trial, with survey, home-food audit, and interview components. hypothesis: the intervention group who received a csa membership as an employee benefit will prepare more meals at home and consume more healthful, fresh foods compared to the control group (no csa participation). using both qualitative and quantitative assessments, outcomes will be measured using 3 primary measures: 1. home food audits at baseline and at week 8 of the intervention. a random selection of participants will have home-food audits completed by members of the research team - those not randomly selected will complete the home-food audit themselves. 2. self-administered surveys, including food frequency questionnaires, at baseline, week 8, and week 16. 3. randomly selected participants will be asked to participate in qualitative interviews at the close of the 16-week intervention period.

Eligibility criteria:
inclusion criteria: * individuals who are non-faculty employees at the university of pennsylvania and university of pennsylvania health system. * individuals who score below the median (50th percentile) on dinners prepared at home on screening survey. exclusion criteria: * individuals who are under the age of 18. * individuals who are already have a csa membership.
applied clinical neuroscience care for self-reported symptoms of depression and cerebellar function in adults

Conditions: Depression

Summary: pilot study design that operationalizes the multimodal manner of care while evaluating changes in depression symptoms, dysmetria, and balance for medication non-responders.

pilot study design that operationalizes the multimodal manner of care while evaluating changes in depression symptoms, dysmetria, and balance for medication non-responders. this research will provide an initial first step towards answering the following three research questions: 1. does a multimodal chiropractic applied clinical neuroscience approach to care affect self-reported symptoms of depression? 2. does a multimodal chiropractic applied clinical neuroscience approach to care affect dysmetria and balance control in a clinically depressed population? 3. are changes in dysmetria and balance control correlated with a change in depressive symptoms.

Eligibility criteria:
inclusion criteria: * you are over the age of 18. * you have been diagnosed with depression. * you are currently taking medication for depression or have previously taken medication. * you have been or were on your depression medication for at least 3 months. * you feel/felt that the medication is/was not helping. exclusion criteria: * had a lifetime history of severe neurologic or mental illness (e.g. schizophrenia or substance abuse) * are pregnant * have pending litigation or a recent history of spinal fracture, metastatic cancer, chiropractic care within the past month * present with contraindications to chiropractic care
diet and exercise for underserved women

Conditions: Obesity

Summary: the purpose is to determine if a culturally tailored diet and exercise intervention of 16 weekly sessions with 8 weeks of followup phone support is effective in reducing waist circumference, weight, and related diet and exercise behaviors among women from underserved communities.

overweight and obesity disproportionately impact economically disadvantaged and minority women. overweight and obese women ages 25 to 50 are recruited from census tracts with 25% or more residents living below poverty-level income. a skills-based intervention was designed with input from women in these communities gathered via focus groups and from a community advisory board. the intervention activities and strategies take into consideration the social and economic challenges of women with limited income, competing demands on their time and cultural beliefs about food preferences and body image.

Eligibility criteria:
inclusion criteria: * 25-50 years of age * live in census tracts with 25% or more below poverty in columbia, sc * waist circumference \>88 cm exclusion criteria: * insulin-dependent * pregnant * moderate exercise contraindicated * not in control of food choices \[institutional setting or restricted diet\] * uncontrolled hypertension * weight \>430 pounds

Keywords: behavioral diet exercise
randomized trial investigating four nasal cpap systems in the management of apnea of prematurity

Conditions: Continuous Positive Airway Pressure; Apnea of Prematurity; CPAP

Summary: the purpose of this study is to evaluate four different nasal continuous pressure systems, which are usually applied on our neonatal intensive care unit, with regard of their effect on bradycardia and desaturations in preterm infants.

background: apnea of prematurity (aop) is a common problem in preterm infants. nasal respiratory support using either continuous positive airway pressure (cpap) or intermittent mandatory ventilation (imv) are, among others, widely used treatments. which of the different systems is the most efficient, however, is unclear. objective: efficiency of different cpap systems on reducing the cumulative percentage of bradycardia and desaturation in preterm infants. methods: in a prospective, randomized, cross-over trial 32 preterm infants infants will randomly allocated to receive nasal cpap delivered by one of the following sys-tems: (1) a conventional imv-system (stephanie, stephan gmbh, germany with pip 15 cmh2o, rr 10/min) delivering cpap via short binasal prongs (hudson rci, usa); (2) the infant-flow-system (eme ltd, great britain) with cpap delivery via short binasal prongs; (3) the infant-flow-advancetm-system used in the pressure assist mode with pip 10 cmh2o, rr 10/min; and (4) a nasal underwater bubble cpap with application via binasal prongs (hudson rci, usa). all systems will be adjusted to achieve an approximate peep of 6 cm h2o. each study lasts 24 hours, during which chest wall and abdominal movements, sao2, tcpco2, ecg, esopha-gus pressure and cpap-/imv-pressure will be recorded continuously. infants will be studied in room air in a 15° head tilt prone position while being treated with caffeine (3mg/kg/d). primary outcome measure cumulative percentage of bradycardia (heart rate \<80/min) and desaturation (sao2 \<80%) per hour.

Eligibility criteria:
inclusion criteria: * gestational age at birth \< 34 weeks * postconceptional age and body weight at study ≤38 week and \>1000 g * requirement for n-cpap to treat aop as judged by the attending neonatologist exclusion criteria: * congenital or chromosomal abnormalities * acute infections * intraventricular hemorrhage * additional inspired oxygen to maintain pulse oximeter saturation spo2 \>92% * patent ductus arteriosus

Keywords: cpap preterm prematurity apnea of prematurity
prednisone timed-release tablet (trt) study: modified-release (mr) formulation of prednisone compared to standard immediate-release (ir) prednisone in participants with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the objective of this study is to investigate if low doses of prednisone mr formulation, given at night and, with active drug release at 2 am, are more effective in controlling joint stiffness, and other disease symptoms of rheumatoid arthritis than standard ir prednisone given in the morning.


Eligibility criteria:
inclusion criteria: * active disease (inflammatory signs, erythrocyte sedimentation rate \[esr\], c-reactive protein \[crp\]) * stable condition * stable basic treatments * morning stiffness on previous treatment with standard prednisone (below or equal to 10 mg per day) greater than or equal to (\>/=) 45 minutes exclusion criteria: * all contra-indications for glucocorticoids * pregnancy * concomitant treatment with biologics * intra-articular injections or synovectomy within the previous 4 months

Keywords: active disease morning stiffness of joints nighttime application of prednisone modified release prednisone