Kornimate/medical-research-clean huggingface dataset:
the effects of a nutrition supplement on health related quality of life

Conditions: Sleep; Stress; Health, Subjective; Inflammation; Cognitive Symptom

Summary: the purpose of this study is to evaluate the health related benefits of a superfoods nutrition supplement on health related quality of life.

after being informed about the study, participants will provide informed consent and be randomized to one of two groups: intervention or control. those in the intervention group will consume two ounces of a superfoods drink each morning for 60 days. outcomes will be assessed at baseline, on day 30 and on day 60.

Eligibility criteria:
inclusion criteria: * otherwise healthy * adults living in the us * is practicing adequate contraception or is abstaining from all activities which could result in pregnancy * understands and agrees to comply with study procedures * provides informed consent exclusion criteria: * smoker * pregnant or may become pregnant * currently breastfeeding * currently taking antioxidant supplements * underlying chronic health conditions * covid-19 diagnosis * demonstrated inability to comply with study procedures * history of allergy to citrus or berry fruits * has participated in an interventional clinical study within 31 days prior to enrollment

Keywords: immune health prevention phytonutrients superfoods antioxidant essential oils
intraabdominal hypertension and occurrence of microaspiration in cirrhotics under mechanical ventilation

Conditions: Critical Illness; Cirrhosis, Liver

Summary: the study aims to demonstrate the relationship between intra-abdominal hypertension (iah) and abundant microaspirations in mechanically ventilated cirrhotic.

intra-abdominal pressure monitoring will be performed using intra-vesical pressure every 8 hour in the first 2 days of mechanical ventilation. micro aspiration is defined by pepsin or amylase positivity in trachea suction. two groups will be compared : one with iah , one without iah.

Eligibility criteria:
inclusion criteria: * adult patients * cirrhosis * intubation and mechanical ventilation exclusion criteria: * pregnancy * oliguric patients * impossibility to measure intravesical pressure
ddi study of bms-663068 with etravirine (etr) and/or darunavir (dvr) + ritonavir (rtv)

Conditions: Infection, Human Immunodeficiency Virus

Summary: the purpose of this study is to determine if there is an interaction in healthy subjects taking bms-663068 with darunavir/ritonavir and/or etravirine.

brief title: drug-drug interaction (ddi) primary purpose: other : phase 1 clinical pharmacology drug interaction study in healthy subjects

Eligibility criteria:
inclusion criteria: * healthy subjects with no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ecg measurements, and clinical laboratory tests * women of childbearing potential (wocbp) allowed. must be practicing highly effective methods of contraception exclusion criteria: * any significant acute or chronic medical condition * unable to tolerate oral medications * inability to be venipunctured and/or tolerate venous access * current or recent (within 3 months of dosing) gastrointestinal disease * abnormal liver function test
clinical orthopaedic data bank (acute and chronic)

Conditions: Osteoarthritis; Osteosarcoma; Scoliosis; Cerebral Palsy

Summary: data involving orthopaedic conditions and rehabilitation aspects of musculoskeletal and neuromuscular disorders will be collected and stored as part of the normal clinical care of patients seen in the university of florida (uf) and shands orthopaedics and sports medicine institute.

all patients seen the orthopaedic clinic will be informed of the data collection and asked to participate. if the patient is agreeable to participation, informed consent will then be obtained.

Eligibility criteria:
inclusion criteria: * all patients seen in the uf\&shands orthopaedics and sports medicine institute will be asked to sign an informed consent. exclusion criteria: * no exclusions, all patients interested in participation will be asked to sign an informed consent.

Keywords: rotator cuff tear
study to evaluate the safety and efficacy of mem 3454 as adjunctive treatment in combination with a preexisting antipsychotic in patients with cognitive impairment associated with schizophrenia

Conditions: Cognitive Impairment Associated With Schizophrenia

Summary: to establish the proof of concept that mem 3454, used as add-on pharmacotherapy, is a safe and effective treatment in patients with cognitive impairment associated with schizophrenia (cias).


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia (any subtype), assessed using a structured interview. * at least one month on the same dose of antipsychotic medication. * clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks. * able to provide informed consent. * fluent in english. * smokers and non-smokers. exclusion criteria: * first 3 years of schizophrenia diagnosis. * current risk of suicide, or history of suicidal behavior within the last 6 months. * hospitalized for psychiatric symptoms in the past 3 months. * other psychiatric diagnoses. * substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according. * nicotine replacement therapy, smoking cessation medications or remedies, including varenicline (chantix).
the effect of hfnc on exercise capacity compared to vm in copd patients recovering from acute evacerbation

Conditions: COPD

Summary: early pr is thought to be effective in copd patients recovering from acute exacerbation, while the effect of hfnc during exercise training in these patients remains unclear. the study may provide evidence of early pr in copd patients recovering from acute exacerbation.

we hypothesize that hfnc may increases exercise time in copd patients recovering from acute exacerbation compare to vm. a randomized, cross-over clinical trial in which either hfnc or vm may be used as an adjunct in 10-mst in random order, respectively, will be performed to compare the endurance time. the physiological effect of hfnc and vm during exercise will also be measured to explore the mechanism.

Eligibility criteria:
inclusion criteria: * hospitalized aecopd patients * be ambulatory by 48h after admission for aecopd * requires oxygen by screening exercise test exclusion criteria: * active coronary ischemia * respiratory diseases other than copd * unstable vital signs * unstable psychological status

Keywords: hfnc pr
the trend of copeptin levels and its clinical value for postoperative cdi in pediatric patients after nsi in icu

Conditions: Diabetes Insipidus, Neurohypophyseal; Copeptin Blood Levels; Copeptin; Neurosurgical Intervention

Summary: central diabetes insipidus (cdi),a disease caused by the decrease of avp (a hormone involved in the control of water-electrolyte balance ) secretion and characerized by polyuria, is a common complication after neurosurgerical intervention and there is a lack of diagnostic criteria.since the surgry casuses damage to patients' avp-secreting neuronal cells, transient cdi (t-cdi) usually occurs 24-48h postoperatively and gradually resolves in about 10 days.however,permanent cdi (p-cdi) occurs in a small percentage of patients.copeptin is a fragment of avp, which has been shown to response the secretion of avp.multiple international studies have identified clinical applications for the use of copeptin to differentially diagnose adults with cdi , to assess electrolyte disturbances associated with avp regulation, and to predict postoperative cdi after pituitary surgery.this study aims to investigate the trend of serum copeptin levels and its clinical value for postoperative cdi in pediatric patients after neurosurgerical intervention in icu.

in children and adolescents, the concentration distribution of copeptin has been gradually explored in recent years,but international studies have not yet shown the trend of copeptin levels in pediatric patients after neurosurgical intervention and its value in predicting cdi. the primary objective of this study is to investigate the trend of serum copetin levels in icu children after neurosurgerical intervention and compare differences of copeptide levels in children with cdi (t-cdi, p-cdi) and non-cdi. the secondary objective is to evaluate the optimal detection time and cut off of copeptin in predicting the postoperative secondary cdi . blood sampling time points of serum copeptin levels are listed as follow: presurgery(t0), 1h (t1), 1 day (t2), 2 days (t3), 3 days (t4), 4 days (t5), 5 day (t6) after surgury.

Eligibility criteria:
inclusion criteria: * male and female,age ≥29 days and \<18 years * after neurosurgical intervention * the patient agrees to comply with the requirements of the program, including follow-up visits and other related matters exclusion criteria: * structural diseases of the genitourinary system (with the possibility of nephrogenic diabetes insipidus) * preoperative symptoms of diabetes insipidus * diabetes mellitus (hba1c \>8.5%) * drugs causing excessive drinking and urination (e.g., sodium-glucose cotransporter-2 inhibitors and diuretics) * lack of follow-up data after 3 months
hbp device egm data collection

Conditions: Sick Sinus Syndrome; AV Block; Heart Failure

Summary: this is a single-arm, non-randomized, non-blinded study designed to collect device data in patients with permanent his bundle (hb) pacing lead and an existing abbott permanent pacemaker, defibrillator, or cardiac resynchronization device. prospective data collection includes surface electrocardiograms, intracardiac electrograms, and pacing parameters, recorded during a patient visit. additional retrospective data collection includes procedural data during the hb pacing lead and device implant. up to 200 subjects will participate in this clinical investigation. the clinical investigation will be conducted at up to 8 centers worldwide. the total duration of the clinical investigation is expected to be 1 year, including enrollment and data collection from all subjects.


Eligibility criteria:
inclusion criteria: * has previously implanted with abbott device and any pacing lead at hb * age ≥ 18 years * ability to provide informed consent for study participation * willing to comply with study evaluation requirements exclusion criteria: * suspected pacing system failure * lead impedance out of range * ventricular sensing amplitude lower than 0.5 mv
metabolic analysis in human sulfur amino acid deficiency

Conditions: Oxidative Stress; Diabetes; Heart Diseases

Summary: varied food intake, disease, and genetic differences result in complex diet-health interactions. in principle, information-rich metabolic analyses combined with bioinformatic tools provide an approach to explore these interactions. this project is a feasibility study of the use of high-resolution 1h-nuclear magnetic resonance (nmr) to study metabolic perturbations induced by a deficiency in sulfur amino acids (saa). the investigators will 1) test the hypothesis that deficient dietary intake of saa in humans results in oxidation of reduced glutathione (gsh)/oxidized glutathione (gssg) redox and 2) determine whether 1h-nmr of blood and urine detects metabolic changes due to saa deficiency.

varied food intake, disease, and genetic differences result in complex diet-health interactions. in principle, information-rich metabolic analyses combined with bioinformatic tools provide an approach to explore these interactions. this project is a feasibility study of the use of high-resolution 1h-nmr to study metabolic perturbations induced by deficiency in sulfur amino acids (saa). in cell culture, sulfur amino acid (saa) deficiency results in substantial oxidation of glutathione (gsh) redox state. because gsh redox affects central homeostatic and cell defense mechanisms, redox changes in vivo due to saa deficiency could induce complex physiologic effects that are not easily predictable by more traditional metabolic analyses. we will 1) test the hypothesis that deficient dietary intake of saa in humans results in oxidation of gsh/gssg redox and 2) determine whether 1h-nmr of blood and urine detects metabolic changes due to saa deficiency. studies will be performed on 12 healthy individuals (6 males, 6 females) in the emory general clinical research center (gcrc) using a crossover design (replete, deficient, replete). kinetic and balance studies will establish the time course and magnitude of changes in saa and metabolites in blood and urine in response to saa intake. plasma gsh/gssg and cysteine/cystine redox will be measured to determine whether variation in intake of saa affects steady-state thiol-disulfide redox state. 1h-nmr spectra of blood and urine samples will be used to determine whether metabolic changes unrelated to the direct saa metabolites can be detected in association with variation in saa intake. the results will show whether variation in saa intake is likely to affect health risks associated with thiol-disulfide redox and oxidative stress. furthermore, because nmr analysis of biofluids can be performed with a high throughput (e.g., 300 samples/day with a flow cell), results will show whether this approach could be useful for nutritional assessment of complex metabolic effects of saa intake.

Eligibility criteria:
inclusion criteria: * normal weight * males or females exclusion criteria: * smokers * pregnancy * chronic illness other than hypertension * age less than 18 and greater than 40 years

Keywords: redox sulfur amino acids glutathione aging
pravastatin or atorvastatin evaluation and infection therapy (timi22)

Conditions: Actue Coronary Syndromes

Summary: the primary purpose of the study was to evaluate 4000 subjects with acute coronary syndrome by comparing pravastatin 40 mg to atorvastatin 80 mg to determine if they are clinically equivalent, and to evaluate the effectiveness of gatifloxacin therapy in reducing cardiovascular events in combination with statin therapy.


Eligibility criteria:
inclusion criteria: * hospitalization for mi or high risk unstable angina within the last 10 days. * total cholesterol 240 mg/dl or greater. * stabilized post acs exclusion criteria: * co-morbidity with life expectations no more than 2 years. * current lipid lowering therapy * corrected qt interval * need for class ia or iii antiarrhythmic agent
study to evaluate the safety and efficacy of seasonale for treatment of low bone mineral density

Conditions: Osteopenia

Summary: this is a randomized, multicenter, placebo-controlled study to evaluate the effects of seasonale, an extended-regimen oral contraceptive, on bone mineral density in adolescent females who have had their menstrual period but now have secondary amenorrhea and also have osteopenia. the duration of the study for each patient will be approximately two years.


Eligibility criteria:
inclusion criteria: * not sexually active and agree to remain sexually inactive throughout the course of the study * first menstrual period at least one year ago * no menstrual period in the last 6 months exclusion criteria: * undiagnosed abnormal genital bleeding * known or suspected pregnancy * medical history of any disorder that contraindicates the use of oral contraceptives

Keywords: osteopenia bone mineral density amenorrhea adolescents
subclinical coronary atheroscleorosis updated with coronary ct angiography (scout study)

Conditions: Coronary Atherosclerosis

Summary: the purpose of this study is to validate the usefulness of 64-slice multi-detecter computeted tomography as a screening tool in asymptomatic population.

a large proportion of patients with sudden cardiac death or nonfatal myocardial infarction (mi) had no prior symptom, which emphasizes the importance of early detection and treatment of the underlying subclinical coronary atherosclerosis before they happen. however, there are no powerful screening methods to detect subclinical coronary atherosclerosis until recently. traditional cad risk factors, treadmill exercise test, and ebct are known to have limited power to detect subclinical coronary atherosclerosis and predict future cardiac events. coronary ct angiography (cta) depicting detailed coronary artery anatomy in a noninvasive fashion would seem to be already one of the mainstays of diagnostic procedure in symptomatic population. instead of the probability of significant stenosis, cta could provide information about the location, burden and characteristics of atherosclerotic plaque per se, which might give additional insight to stratify the risk of future cardiac events and therapy. in this study, we will evaluate the prevalence and characteristics of subclinical coronary atherosclerosis on cta and its impact on the management in asymptomatic population. and then, we will develop standardized protocol for the management of subclinical coronary atherosclerosis, and follow for adverse cardiac events. in phase i study, we will enroll subjects who had undergone cta and analyze the characteristics of plaques on cta. also, we will evaluate the impact of cta by comparing the performance of secondary test with those who had not undergone cta evaluation. in phase ii study, we will recruit subjects who had significant coronary stenosis on cta. if the patients had significant stenosis, they will undergo coronary angiography to confirm the severity of stenosis. if they had coronary artery stenosis more than 75%, they will receive percutaneous coronary intervention with drug-eluting stent (des). if they had intermediate lesion, their treatment option will be judged by the results of fractional flow reserve test. if they had coronary lesion less than 50%, they will be treated only by medication. when the patients are eligible for study, investigators will give information about the study and obtain written consent. the presence of chest pain symptom will be screened with rose questionnaire. medical history and physical examination will be performed, and baseline laboratory work-up will be performed. following above treatment guidelines, all patients will be followed for adverse cardiac events for 5 years.

Eligibility criteria:
inclusion criteria: * asymptomatic subjects * 20-75 years * subjects who had undergone spiral coronary ct angiography for health check-up exclusion criteria: * typical or atypical chest pain * serious comorbid conditions(i.e. malignancy)

Keywords: coronary atherosclerosis, spiral computed tomography
steroids in the management of acute asthma exacerbations in children, which form is more suitable?

Conditions: Steroids In Management Of Acute Asthma Exacerbations

Summary: the aim of this study is to compare the efficacy of a single dose of intramuscular dexamethasone versus 3 days of twice-daily oral prednisolone in the management of mild to moderate asthma exacerbations in children and test whether this single dose of intramuscular dexamethasone 0.6 mg/kg (max. 18 mg) is equal to prednisolone 1 mg/kg/day (max. 40 mg) in the treatment of exacerbations of asthma in children, as measured by the pediatric respiratory assessment measure (pram).

this study will be performed in assiut university children hospital and will include patients with asthma exacerbations presented to the emergency department for three months. all children presenting to the emergency department with mild to moderate asthma exacerbations will be assessed to decide if the child needs treatment with salbutamol. before starting treatment the pediatric respiratory assessment measure (pram), vital signs, and oxygen saturation will be recorded. peak expiratory flow rate (pefr) will also be recorded if the patient was 6 years or older. children with mild to moderate asthma exacerbation will be given the first dose of salbutamol and will be reassessed after 20 min by the emergency department attending. if further salbutamol is needed, subjects automatically will receive the second dose 20 min apart and receive either single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) or oral prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally . a repeat physical examination will be performed, including oxygen saturation, vital signs, pram, pefr after the 3rd dose of salbutamol and at the end of the third day to evaluate the effect of prednisolone and dexamethasone on the improvement of asthma scores. patient compliance to prednisolone therapy for three days will be also recorded. this study will be performed in pediatric hospital - assiut university and will include patients with asthma exacerbations presented to the emergency department for three months.

Eligibility criteria:
inclusion criteria: * ages 2 to 16 years * background history of asthma * presentation with an asthma exacerbation requiring repeated salbutamol after 20 minutes. exclusion criteria: * less than 2 years old or over 16 years * critical or life-threatening asthma * known tuberculosis exposure * active varicella or herpes simplex infection * documented concurrent infection with respiratory syncytial virus * fever \>39.5°c * use of oral corticosteroids in the previous four weeks * concurrent stridor * significant co-morbid disease: lung, cardiac, immune, liver, endocrine, neurological or psychiatric
effectiveness of higher aspirin dosing for prevention of preeclampsia in high risk obese gravida

Conditions: Pre-Eclampsia; Hypertension in Pregnancy; Obesity

Summary: to compare the incidence of preeclampsia in obese pregnant women (bmi greater than 30) with a singleton gestation at less than 20 weeks and either a history of preeclampsia in a prior pregnancy or stage i hypertension or pre-gestational diabetes who are randomized to either 81mg/day aspirin or 162mg/day aspirin.


Eligibility criteria:
inclusion criteria * a singleton gestation at less than 20 weeks at time of enrollment, with a bmi greater than or equal to 30 and one of the following: 1. history of preeclampsia in a prior pregnancy * diagnosis will be obtained by review of records, and if unavailable then patient history. preeclampsia diagnosis may be made in antepartum or postpartum period. or 2. at least stage i hypertension during pregnancy * stage i hypertension is defined as a systolic blood pressure between 130- 139 mm hg or diastolic blood pressure between 80-89 mm hg21 * this blood pressure criteria is met regardless of medication usage * the patient must have a blood pressure reading ≥ 130-139/80-89 mm hg at least during 1 clinic visit during the current pregnancy; before or at time of enrollment or 3. pre-gestational diabetes * type 1 and type 2 diabetics are included * gestational diabetes mellitus diagnosed prior to 20 weeks gestational age will also be included exclusion criteria * known allergy/prior adverse reaction/any medical condition where aspirin is contraindicated * already on aspirin prior to pregnancy * baseline renal disease * baseline proteinuria identified at time of enrollment, defined as urine analysis with 3+ protein, or urine protein to creatinine ratio ≥ 0.3 * systemic lupus erythematosus * seizure disorder on medications * hiv positive status * known major fetal anomalies * multifetal gestation