Kornimate/medical-research-clean huggingface dataset:
individualized nutrition to optimize preterm infant growth and neurodevelopment

Conditions: Very Preterm Maturity of Infant; Very Low Birth Weight Infant

Summary: human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification. in u.s. neonatal intensive care units (nicus), human milk is primarily supplemented using standardized fortification, in which a multicomponent fortifier is added to human milk to achieve assumed nutrient content based on standard milk reference values. however, this method does not account for the significant variability in human milk composition or in preterm infant metabolism, and up to half of all very premature infants experience poor growth and malnutrition using current nutritional practices. poor postnatal growth has adverse implications for the developing preterm brain and long-term neurodevelopment. recent advances allow for individualized methods of human milk fortification, including adjustable and targeted fortification. adjustable fortification uses laboratory markers of protein metabolism (bun level) to estimate an infant's protein requirements. in targeted fortification, a milk sample is analyzed to determine its specific macronutrient and energy content, with additional macronutrient supplementation provided as needed to achieve goal values. emerging data suggest that both methods are safe and effective for improving growth, however information on their comparable efficacy and neurodevelopmental implications are lacking, particularly using advanced quantitative brain mri (qmri) techniques. through this prospective, randomized-controlled trial, the investigators will compare the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants. infants will be randomized to receive one of three nutritional interventions: standardized (control group), adjustable, or targeted human milk fortification. infants will undergo their assigned nutritional intervention until term-equivalent age or discharge home, whichever is achieved first. brain qmri will be performed at term-corrected age, and neurodevelopmental follow-up will be performed through 5 years of age.


Eligibility criteria:
inclusion criteria: * birth gestational age (ga) of ≤32 weeks * postnatal age ≤4 weeks at time of enrollment * maternal plan to provide human milk to infant, and consent to providing donor human milk if insufficient maternal milk supply * maternal age \> 18 years old exclusion criteria: * formula feeding prior to 36 weeks pma or discharge home (whichever achieved first), either secondary to parental preference or medical necessity * dysmorphic features or congenital anomalies suggestive of a genetic syndrome, metabolic disorder, chromosomal abnormality, or congenital infection * dysgenetic or major destructive brain lesions detected by head ultrasound before enrollment

Keywords: magnetic resonance imaging neurodevelopment nutrition fortification
a study of pegasys (peginterferon alfa-2a (40kd)) in patients with chronic hepatitis c and chronic renal failure.

Conditions: Hepatitis C, Chronic

Summary: this single arm study will assess the efficacy and safety of pegasys in patients with chronic hepatitis c and end-stage renal disease, including patients on hemodialysis. patients will receive pegasys at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of \<15ml/min will receive a reduced dose of 135 micrograms weekly. following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-60 years of age; * chronic hepatitis c; * chronic renal failure, including patients on hemodialysis therapy; * detectable hcv rna levels (\>500iu/ml). exclusion criteria: * concurrent active hepatitis a or b; * history or evidence of a medical condition associated with chronic liver disease other than hcv; * history or other evidence of decompensated liver disease; * therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment \<=6 months prior to study; * acute renal failure.
study of the prevalence of tgfbi corneal dystrophies

Conditions: Corneal Dystrophy

Summary: to determine the prevalence of 5 specific corneal dystrophies in a subgroup of patients seeking refractive surgery, and to use that information to inform them and their refractive surgeons of the presence of the corneal dystrophies so that they may make safer choices when considering refractive surgery.

it is well established in the peer-reviewed literature that elective keratorefractive surgery is contraindicated in individuals with granular corneal dystrophy type 2 (gcd2).1,2,3,4 although all reported cases of exacerbation of dystrophic stromal deposits have been in individuals with gcd2, it may be assumed that a similar accelerated deposition would occur in individuals with any of the tgfbi dystrophies, and thus elective keratorefractive surgery should be avoided in any individual with a tgfbi dystrophy. the commercially available avellino refractive surgery safety test (avellino universal test) offers an accurate, rapid and affordable way to screen for five corneal dystrophies associated with mutations in the tgfbi gene prior to keratorefractive surgery. these dystrophies are granular dystrophy type 1 (gcd1), gcd2, lattice corneal dystrophy type 1 (lcd1), reis-buckler corneal dystrophy, and thiel- behnke corneal dystrophy. this is a multicenter, cross-sectional, observational study of the prevalence of tgfbi corneal dystrophies in a north american population. patients presenting to the clinical site for an ocular examination with a refractive complaint (non-medical complaint) or for refractive surgery consultation will be asked to participate in this study. prior to the collection of any study data, informed consent will be obtained. a a serial number / bar code controlled case report form (crf) single nucleotide variants implicated in the pathogenesis of the tgfbi corneal dystrophies. the crf will be used to collect demographic information from the patient. slit lamp examination of the corneas will be performed, and the presence or absence of corneal opacities, whether characteristic or not of a tgfbi dystrophy, will be documented on the crf form. once all data has been collected, descriptive statistics will be computed to identify the prevalence of each of the tgfbi corneal dystrophies as defined by the genotype. demographic data will be compared between unaffected individuals and those identified to have a coding region mutation associated with one of the five aforementioned tgfbi corneal dystrophies.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * able and willing to provide written informed consent and sign a hipaa form. exclusion criteria: • none
clinical study of macitentan in patients with pah to psychometrically validate pah-sympact instrument

Conditions: Pulmonary Arterial Hypertension

Summary: symphony extension is an extension of ac-055-401, a multi-center, open-label, single-arm, phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the pah-sympact instrument. the objective is to assess the long-term safety of macitentan in subjects with pah beyond the treatment in the ac-055-401 study.


Eligibility criteria:
inclusion criteria: * signed informed consent prior to any study-mandated procedure. * patients with pah who completed study ac-055-401 * women of childbearing potential must: * have a negative urine pregnancy test at visit 1 and agree to perform monthly serum pregnancy tests. * agree to use two methods of contraception from visit 1 until 1 month after study drug discontinuation. exclusion criteria: * patients who prematurely discontinued study drug in study ac-055-401 * females who are lactating or pregnant (positive visit 1 pregnancy test) or plan to become pregnant during the study * known hypersensitivity to macitentan or its excipients or drugs of the same class

Keywords: pulmonary arterial hypertension (pah) psychometric instrument pah-sympact
a controlled trial to investigate the efficacy and safety of frovatriptan to prevent menstrual migraine

Conditions: Migraine

Summary: although the predictability of an mrm headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of mm. such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period or pmp) or continuously throughout the menstrual cycle. frovatriptan has been developed for the management of migraine and is already licensed for use as an acute treatment for this condition. previous well controlled clinical trials have highlighted the potential of frovatriptan as a short-term preventative medication for mm. this clinical trial was meant to further explore this indication for frovatriptan in an expanded population.

see above

Eligibility criteria:
inclusion criteria: * pre-menopausal females diagnosed as suffering from mrm aged 15 years and over, that fit the criteria for 'difficult to treat'

Keywords: menstrually-related migraine headache 'difficult to treat' as specified in protocol
avaps-ae efficacy study

Conditions: Obesity Hypoventilation Syndrome

Summary: the purpose of this study is to evaluate the feasibility of using of the average volume assured pressure support (avaps-ae) mode versus continuous positive airway pressure (cpap) and bilevel pressure support ventilation (psv) modes of ventilation in patients diagnosed with obesity hypoventilation syndrome (ohs). the investigators believe the use of the avaps-ae mode of ventilation after 6 weeks will yield daytime gas exchange values which are equivalent or no worse when compared to using cpap and bilevel psv modes of ventilation in the ohs population.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years of age; less than or equal to 70 years of age * diagnosis of obesity hypoventilation syndrome via a diagnostic sleep study in the past 3 months but have not initiated therapy * bmi greater than or equal to 30 kg/m2 * daytime paco2 greater than or equal to 45 mmhg * apnea hypopnea index (ahi) \> 5 * daytime ph \> 7.35 * forced expiratory volume at 1 second / forced vital capacity (fev1/fvc) \> 70% exclusion criteria: * acutely ill, medically complicated or who are medically stable, or as otherwise determined by the investigator * respiratory alkalosis (ph \> 7.45), per investigator discretion * emergency admissions on chronic respiratory failure * hospitalization for respiratory exacerbation \< 6 weeks prior to screening visit * participants in whom pap therapy is otherwise medically contraindicated * impaired upper airway function. for example, obstruction due to infections(laryngitis, epiglottis), craniofacial malformations, tumors, uvulopalatopharyngoplasty, presence of tracheostomy, or bilateral vocal cord palsy that does not allow tolerance of non-invasive positive pressure ventilation (nppv) * facial trauma, burns, surgery or anatomical abnormalities interfering with mask fit.

Keywords: ohs
second-look ultrasound post contrast-enhanced mammography for additional lesions characterization

Conditions: Breast Cancer Diagnosis; Breast Cancer Detection

Summary: this study investigates the utility of second-look ultrasound (us) following contrast-enhanced mammography (cem) to characterize additional lesions detected during routine breast imaging.

the goal is to assess the diagnostic accuracy and clinical value of combining cem with targeted ultrasound to improve lesion characterization and guide biopsy decisions.

Eligibility criteria:
inclusion criteria: * patients undergoing contrast-enhanced mammography for diagnostic or surveillance purposes. * identification of additional lesions on cem requiring further evaluation. * ability to provide informed consent. exclusion criteria: * known breast cancer diagnosis without suspicion of additional lesions. * contraindications to ultrasound or contrast agents. * patients with incomplete imaging data.

Keywords: second look ultrasound contrast enhanced mammography breast cancer detection
optimized cardioprotection therapy in obese subjects with ami

Conditions: Acute Myocardial Infarction; Myocardial Reperfusion Injury; Obesity; Adiposis; Heart

Summary: the purpose of this study is to investigate the efficacy and mechanism of adipokines cardiac protection in obese patients with acute myocardial infarction (ami) who have undergone percutaneous coronary intervention (pci).

adipokines (or adipocytokines) can be defined as a group of more than 600 bioactive molecules made from adipose tissue that acts as paracrine and endocrine hormones. adipokines are involved in maintaining varieties of processes such as, appetite and satiety, energy expenditure activity, endothelial function, blood pressure, hemostasis, adipogenesis, insulin sensitivity, energy metabolism in insulin-sensitive tissues, fat distribution and insulin secretion in pancreatic β-cells. adipokines may contribute to reduce scar formation and improve cardiac function in acute myocardial infarction (ami). reperfusion therapy such as percutaneous coronary intervention (pci) should be administered to all eligible patients with ami symptom onset within the prior 12 hours. however, our previous work showed that obese patients may benefit more from pci. thus, the aim of the present study was to investigate the efficacy and mechanism of adipokines cardiac protection for obese and non-obese patients with acute myocardial infarction (ami) who have undergone pci.

Eligibility criteria:
inclusion criteria: age between 20 and 70 years old stemi and nstmi according to the who definition pci \<12 hours from the onset of symptoms exclusion criteria: previous myocardial infarction (mi) cardiomyopathy atrial fibrillation or flutter previous heart surgery severe valvular heart disease disease of the hematopoietic system nyha functional class iv heart failure at baseline severe renal, lung and liver disease cancer

Keywords: adiposis obesity acute myocardial infarction percutaneous coronary intervention left ventricular function
long term cardiovascular disease event risk for patients undergoing major non-cardiac surgery

Conditions: Cardiovascular Diseases; Risk Reduction Behavior

Summary: the goal of this observational study is to learn whether the healthy lifestyle choices made around surgery can influence an individual's long term risk of developing cardiovascular disease. patients will be observed 1-month prior to and 3-months following surgery to assess their risk of developing cardiovascular disease.

patients who experience a medical event are often motivated to improve their health by engaging in healthy lifestyle behaviors, such as improving their diet and beginning to exercise. for example, patients who are considered smokers prior to surgery may sometimes stop smoking following surgery. however, we are unsure of other changes following surgery. for example, we are unsure if surgery can initiate any changes in exercise and diet, and we are unsure if these changes can influence the risk of developing cardiovascular disease. consistent and positive lifestyle changes will likely reduce an individual's risk of developing cardiovascular disease in the long term.

Eligibility criteria:
inclusion criteria: * age 45 - 75 years * scheduled for intermediate- to high risk non-cardiac surgery (intra-thoracic or intra-abdominal surgery, all vascular surgery, intra-cranial neurosurgery, spine surgery) * expected post-operative length of stay of at least two days, according to the surgeon's expectation * at least two of the following cvd risk factors: history of: hypertension, diabetes, coronary artery disease, chronic heart failure, chronic kidney disease, cerebrovascular disease, peripheral vascular disease. obesity (bmi \>25 kg/m2), current smoking, poor exercise capacity (\<4 mets) exclusion criteria: * currently participating in a cvd risk reduction program * patient is scheduled to undergo transplant or has undergone emergency surgery * life expectancy \<1 year (palliative surgery) * recent (\<6 months) myocardial infarction or stroke * surgery scheduled \<1 month * inability to effectively communicate

Keywords: intermediate to high risk non-cardiac surgery
the effects of mycophenolate mofetil (mmf) on renal outcomes in advanced immunoglobulin a (iga) nephropathy patients

Conditions: IgA Nephropathy

Summary: the study is to evaluate the effect of mycophenolate mofetil compared with losartan alone on time to doubling of serum creatinine or the onset of end stage renal disease in patients with advanced iga nephropathy who are treated with the maximal tolerated daily dose of losartan.the study will also assess the effects of mmf compared with losartan alone on the changes of urine albumin excretion and the changes in estimated glomerular filtration rate.


Eligibility criteria:
inclusion criteria: * biopsy-proven primary iga nephropathy with urinary proteinuria excretion over 1g/24 hour,subjects must meet 2 of the following criteria: 1. global glomerular sclerosis plus focal segmental glomerular sclerosis ratio ≥50% 2. egfr 30 to 60 ml/min 3. hypertension (blood pressure over 140/90 mmhg or taking antihypertensive drugs) exclusion criteria: 1. secondary iga nephropathy 2. familial iga nephropathy 3. concomitant disease: cancer, infection, diabetes mellitus, connective tissue disease, abnormal liver function 4. pregnancy or breasting 5. inability to comply with study and follow-up procedures
high intensity laser therapy (classes iv) and ibuprofen gel phonophoresis for treating knee osteoarthritis

Conditions: Osteo Arthritis Knee

Summary: a total of 80 patients with knee osteoarthritis (koa) aged between fourty five and seventy years will be recruited by simple random sampling to participate in two group, randomized, double blind, controlled study. recruited patients will be randomly divided in to two groups high intensity-laser therapy (hilt) group and ibuprofen gel phonophoresis (igp) group. duration of the treatment will be 8 minutes in one session/knee joint for each day for 3 days/week for 8 weeks.the pain and quality of life will be assessed at the baseline and at the end of 8-week post-intervention period.


Eligibility criteria:
inclusion criteria: * patients diagnosed with clinical knee oa according to the diagnostic criteria of acr were included in the study exclusion criteria: * unwillingness to participate in the study * recent history (within the last 3 months) of physical therapy to the same joint * recent history (within the last 3 months) of intra-articular procedure (injection and/or lavage) to the knee * history of knee surgery/fracture * acute synovitis/arthritis including the infectious conditions * presence of malignancy * pregnancy * taking pain relief medications

Keywords: knee osteoarthritis incline walking degeneration ultrasound laser therapy
treatment of metabolic syndrome in a community mental health center

Conditions: Serious Mental Illness

Summary: the purpose of this study is to learn if patients being treated with second generation antipsychotics and with clinically meaningful elevations/levels in any metabolic syndrome elements will have better access to medical treatment more quickly if they are randomized to one of the following conditions: 1) a primary care provider located in the community mental health center where mental health treatment is provided (imbed), 2) a medical care manager to help coordinate treatment with an outside primary care provider (liaison) or 3) the standard practice of advising the patient to see a primary care doctor (treatment as usual).

individuals will be identified for participation based upon baseline laboratory values obtained at the local community mental health clinic (cmhc) as part of the standard monitoring procedures for individuals on second generation antipsychotics (sgas). following randomization, a research assistant will be assigned to obtain information on primary care provider visits, medications and lab tests conducted outside of the cmhc using a signed release for from the patient. variables collected include: date and time of all physician or practitioner visits, type of practitioner, all medication prescriptions, and all laboratory values and vital signs related to metabolic syndrome parameters. data will be put into an access data base for analysis. data from private pharmacies will be obtained using a separate signed consent form.

Eligibility criteria:
inclusion criteria: * males and females 18 years and older * active cmhc consumers * currently taking an atypical antipsychotic * identified as having clinically meaningful elevations/levels in metabolic indicators; i.e. fasting blood glucose (≥ 110), hdl ≤ 40mg/dl for males or ≤ 50mg/dl for females, blood pressure (≥ 130/85) * able to give informed consent * recipient of private or publicly-financed health insurance that includes medication coverage exclusion criteria: * legally declared mentally incompetent (guardians will not be approached about study)
efficacy and safety of ver-01 in the treatment of patients with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the aim of the trial is to prove the efficacy and safety of ver-01 corresponding to 22.5 mg or 32.5 mg thc compared to placebo in patients with chronic low back pain (clbp) for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.


Eligibility criteria:
inclusion criteria: * chronic (≥ 6 months) pain in the lower back (between the 12th thoracic vertebra and lower gluteal folds). clbp patients without a clear specific somatic cause, for which targeted therapy can have a positive effect on the course of the disease. * patients with indicated opioid drug treatment where previous optimized treatments with non-opioid analgesics (including combinations) have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance exclusion criteria: * any painful comorbidity which could, in the opinion of the investigator, interfere with the low back pain intensity assessment during the trial participation * pregnant or breastfeeding female patients * known history of previous or current severe psychiatric disorder as per dsm-5 (e.g., schizophrenia, bipolar disorder, severe anxiety disorder, psychotic disorder, post-traumatic stress disorder), or currently taking antipsychotic medication. * cardiovascular event or clinically significant cardiac dysfunction (e.g., congestive heart failure, myocardial ischemia, arrhythmias, poorly controlled high blood pressure, congenital long qt syndrome) within 12 months prior to visit 1 or a cardiac disorder that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction.
periodontopathogens of periodontal patients

Conditions: Periodontal Diseases

Summary: study the presence of periodontal pathogens in a catalan population with periodontitis and evaluate the influence of an intervention measure on oral hygiene teaching (video)


Eligibility criteria:
inclusion criteria: * patients over 18 years of age * periodontal disease (grade iii and iv) * gave their informed consent to participate in the study * do not present associated medical pathology exclusion criteria: * patients who do not wish to participate in the study * patients following active treatment with antibiotics or having received antibiotic treatment in the last seven days, * patients who wear braces.

Keywords: periodontopathogens oral hygiene periodontal patients