Kornimate/medical-research-clean huggingface dataset:
sodium supplementation and growth in very low birth weight infants

Conditions: Extreme Immaturity

Summary: adequate growth during the neonatal period is critical for optimal long term outcomes. despite maximal calorie intake, sixty percent of very low birth weight infants still fail to thrive suggesting that factors other than total calorie intake are important in ensuring consistent weight gain. several reports have indicated a positive sodium balance is critical in ensuring good weight gain in very low birth weight infants, however these infants are susceptible to low serum sodium concentrations. urine sodium values are sometimes used to diagnosis of hyponatremia or negative sodium balance after the first two weeks of life, but there is no evidence for this practice in preterm neonates. our central hypothesis is that early supplementation with sodium will ensure positive sodium balance in very low birth weight infants and will result in optimal weight gain and enhanced long term outcomes. secondarily we hypothesize that low sodium concentrations in the urine will not correlate with low serum sodium values.

this is a randomized, blinded, placebo-controlled trial in infants born at less than 32 weeks gestation, who are admitted to the newborn intensive care unit at university of cincinnati medical center, cincinnati, ohio. infants are randomized to receive either 4 meq/kg/day supplemental sodium or an equal amount of sterile water on days of life 7-35. institutional data from 2008 revealed that a sample size of 56 infants completing the study will detect a 15% difference in the primary outcome of weight gain with 80% power and an alpha error of 0.05. allowing that 33% drop-out rate (infants may be transferred to another hospital, expire, or be discharged prior to day of life 35), we choose to randomize 75 infants. calorie intake, serum sodium, weight gain, urine sodium were monitored weekly till 35 days of life or discharge. infants were assessed for common morbidities associated with prematurity including bronchopulmonary dysplasia, systemic hypertension, late-onset sepsis, necrotizing enterocolitis and retinopathy of prematurity.

Eligibility criteria:
inclusion criteria: * infants born at less than 32 weeks postmenstrual age exclusion criteria: * infants with major malformations deemed incompatible with life disease states characterized by edema renal failure, defined as an increase in serum creatinine by 0.5 mg/dl/day or urine output less than 0.5 ml/kg/hour

Keywords: anthropometrics weight nutrition
antecedents of hypertension: role of race and stress

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to determine the role of environmental stressors in the development of hypertension in black and white school-age children from hypertensive families.

background: the theoretical rationale for the role of environmental stress factors in the development of essential hypertension has been outlined in several studies. briefly, individuals at increased risk for essential hypertension are more likely than non-risk cohorts to exhibit exaggerated cardiovascular reactivity to environmental stressors. this may be especially true for blacks compared to whites. furthermore, individuals at risk for developing essential hypertension who are subjected to more frequent physical and/or sociopsychological stressors may experience frequent feelings of anger and hostility with concomitant exaggerated cardiovascular reactivity. blacks may experience many of these stressors more frequently than whites. the exaggerated cardiovascular reactivity, in turn, is associated with complex neuroendocrine changes which result in pathophysiological alterations, eventually causing chronic elevated blood pressure. although this rationale has received some empirical support in animal and human studies, definitive evidence to support an etiologic role of environmental stress factors is still lacking and needs to be tested in a prospective manner. design narrative: the study was cross-sectional and longitudinal. an estimated 1,523 children, 7 to 14 years old at baseline, whose families reported essential hypertension, participated in a blood pressure screening following medical verification of their family history of hypertension. children whose systolic blood pressures were in the 5th to 25th percentiles or 75th to 95th percentiles were recruited. a sample of children was obtained with relatively equal distributions by race, age, gender, and blood pressure grouping. environmental stress factors evaluated include: psychophysiological responses to physical and psychological stressors including physical exercise testing, video game, and mental arithmetic tests; sociopsychological variables including anger and hostility coping styles; and sociostructural variables including socioeconomic status and family stability. the environmental risk factors were assessed within the context of other hypertension risk factors such as cholesterol level, sodium and alcohol intake, tobacco usage, resting blood pressure, and body weight. each child and his parents were followed annually. the study was renewed in 1994 and again in 1998 to continue follow-up for an additional four years. follow-up continued of these adolescents and young adults who were 13 to 20 years old in 1998. the purpose was to index early markers of preclinical disease including resting blood pressure, left ventricular mass, and several new measures including plasma endothelin-1 (et-1) and endothelium dependent arterial dilation (edad).

Eligibility criteria:
no eligibility criteria
calerie (washington university): comprehensive assessment of long-term effects of reducing intake of energy

Conditions: Aging

Summary: this study is one of three calerie trials that test the hypothesis that a reduced calorie, nutritionally sound diet increases the length of life and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. the three sites that are participating in the calerie trial represent a diversity of subject populations and interventional strategies.

animal studies suggest that caloric restriction (cr), or consuming fewer calories, increases life span, and also protects against some aging-related disease processes such as artherosclerosis and type ii diabetes. however, it appears that simply burning more calories through physical activity does not increase life span by itself. it is not known how cr affects humans, but based on this evidence it appears that the reduced total intake and metabolism of food is the main factor, rather than increased exercise alone. to test this, volunteers will be placed on a program of either 20% caloric restriction or 20% increase of energy expenditure by exercise, or in a control group to be instructed in healthy living. all will be evaluated on a number of potential markers of aging, on body composition, and on risk factors for artherosclerosis and diabetes. participation in the study will last for 12 months. the diet group will receive individual instruction from a registered dietician. the exercise group will be given an individualized exercise program created by a personal trainer. the healthy lifestyle group will be given information on how to make healthier choices; both diet and activity will be discussed. all participants will be measured every two weeks, and will keep daily food and activity logs. all will be seen by a physician and will have lab tests done before beginning the study, at 1 month, and then 3 month intervals.

Eligibility criteria:
inclusion criteria: * age 50 to 60 * women must be post-menopausal * normal weight to moderately overweight, (body mass index \[bmi\] between 23 - 30) * in good health, free of major chronic diseases or conditions * well motivated * reliable exclusion criteria: * major chronic disease or condition that would interfere with exercise or caloric restriction (such as diabetes, coronary artery disease, significant obstructive airway disease, stroke, resting blood pressure over 170 mmhg systolic and/or 100 mmhg diastolic, history or evidence of malignancy, orthopedic or musculoskeletal problems) * hormone replacement therapy (dhea, estrogen, thyroid, testosterone) * regular exercise twice or more per week * smoking * alcoholism * frequent travel

Keywords: diet caloric restriction exercise energy metabolism primary aging secondary aging
a study of c-car168 in the treatment of autoimmune diseases refractory to standard therapy

Conditions: Systemic Lupus Erythematosus (SLE); Immune-Mediated Necrotizing Myopathy; Neuromyelitis Optica Spectrum Disorders; Multiple Sclerosis-Relapsing-Remitting; Myasthenia Gravis

Summary: this is an investigator-initiated, multicenter, open-label study of c-car168, an autologous bi-specific car-t therapy targeting cd20 and bcma, for the treatment of adult patients with autoimmune diseases refractory to standard therapy


Eligibility criteria:
inclusion criteria: * 18 to 70 years old at the time of signing the informed consent form (icf). * diagnosed as sle/immune-mediated necrotizing myopathy (imnm)/neuromyelitis optica spectrum disorders (nmosd)/multiple sclerosis (ms)/myasthenia gravis (mg) according to recognized diagnostic criteria for at least 6 months. * remains disease active or relapses after treatment with standard of care therapy for at least 8 weeks with the dose stable for more than 2 weeks; patients should have been treated at least two immunosuppressants (immunosuppressants or disease-modifying drug (dmd) for ms participants). * adequate bone marrow, coagulation, cardiopulmonary, liver and renal function. exclusion criteria: * hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv), treponema pallidum (tp) positive, cytomegalovirus (cmv) dna positive. * uncontrolled active infection. * live vaccine injection within 4 weeks prior to signing the icf. * major organ transplantation history or bone marrow/hematopoietic stem cell transplantation history. * severe cardiovascular diseases within the past 6 months prior to screening. * ≥ grade 2 bleeding within the past 30 days prior to screening, or requiring long-term anticoagulants treatment. * inadequate washing time for previous treatment. * previously treated with car-t cell products or genetically modified t cell therapies. * pregnant or lactating women. * severe central nervous system diseases or pathological changes. * malignancy history within 5 years prior to signing the icf.

Keywords: cd20/bcma-directed car-t cells
femoral neuropathy after anterior cruciate ligament reconstruction: femoral nerve block vs patient-controlled analgesia (pca)

Conditions: Femoral Neuropathy

Summary: femoral neuropathy after anterior cruciate ligament reconstruction with femoral nerve block may be as high as 24% at 6 postoperative weeks when evaluated prospectively and systematically through a clinical neurological and an electroneuromyography (enmg). it is still unclear whether this neuropathy is the result of the surgery, especially the tourniquet, or the block nerve. the goal of this study is to define the etiology of this postoperative neuropathy.

anterior cruciate ligament reconstruction is associated with moderate to severe postoperative pain. among different analgesic strategies, continuous femoral nerve block is reported as an efficient method, reducing opioid consumption and allowing rapid rehabilitation; however, patients may develop a transient neuropathy after surgery, which could have a significant impact on active patients, particularly on athletes who need immediate rehabilitation and who will put their knee to greater use during the postoperative period. this study is designed to compare the incidence of femoral neuropathy in two groups of patients: one with a femoral nerve block, and one with a pca of morphine (self-iv administration of morphine). all patients will have a clinical neurological exam with a preoperative enmg in order to rule out a pre-existing neuropathy. another clinical neurological exam with enmg will be performed between 4 and 6 weeks and, if pathological, repeated at 6 months, 9 months and 12 months. the operation will be done under general anesthesia for all patients.

Eligibility criteria:
inclusion criteria: * patients planned for anterior cruciate ligament reconstruction * asa 1 and 2 * age 16 years and more exclusion criteria: * peripheral neuropathy * pre-existing femoral neuropathy * diabetes mellitus * alcoholism * drug addiction * cancer with chemotherapy * chronic pain state

Keywords: electrophysiological study nerve block analgesia, patient-controlled anterior cruciate ligament
study of methylnaltrexone (mntx) for the relief of constipation

Conditions: Advance Illness Patients With OIC

Summary: to determine the efficacy of subcutaneous mntx to relieve opioid-induced constipation in patients with advanced medical illness.

this is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. eligible patients are randomly assigned to receive sc doses of either mntx, dose 1 or placebo every other day for 2 weeks. at day 8, eligible patients, if allowed, could be escalated to a a higher dose of mntx.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * negative pregnancy test (serum or urine) at screening for all women of childbearing potential * advanced medical illness (i.e., terminal illness, such as incurable cancer or end of stage aids) with life expectancy of ≥ 1 month * patient must sign icf exclusion criteria: * women who are pregnant and/or nursing * previous treatment with mntx * participation in any other studies involving investigational products within 30 days prior to screening
evaluating the efficacy of an absorbent foam dressing containing silver (mepilex ag) versus the same dressing without silver used on subjects with venous leg ulcers or mixed ulcers

Conditions: Venous Leg Ulcers; Mixed Leg Ulcers

Summary: compare the efficacy of using an absorbent foam silver dressing (mepilex ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an abpi ≥ 0.8 and with inflammatory signs. efficacy will be defined as absolute wound size reduction.


Eligibility criteria:
inclusion criteria: * subjects with colonised/ local infection in a venous leg ulcer or mixed leg ulcer with an abpi ≥ 0,8 and \< 1.3 * a history of an appropriate compression therapy for at least 2 weeks prior to randomisation * subjects with colonised/local infection presenting with three of five following specified signs: * pain between dressing changes * exuding wounds * erythema on peri-wound skin * oedema * odour * an ulcer size of at least 4 cm2 and a maximum size witch could be covered by one investigational product of 15x15 cm. * ulcer duration 6 weeks to 1 year * in case of multiple ulcers: target ulcer must be at least 3 cm distant from other ulcers. * both gender with an age ≥ 18 years * signed informed consent exclusion criteria: * \> 10% necrotic (black) or fibrinous (yellow) tissue covering the wound bed * infected wounds in need of systemic antibiotic treatment * use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included * previous treatment with silver product 2 weeks prior to inclusion * previous treatment with mepilexag® on the target ulcer * use of systemic antibiotics for any reason during the previous 7 days * venous surgery 2 weeks prior to inclusion or planned surgery within 8 weeks after inclusion * diagnosed underlying disease(s) (e.g. hiv/aids, cancer/malignancy and severe anaemia) judged by the investigator to be a potential interference in the wound evaluation * subjects with poorly controlled diabetes mellitus i.e. hba1c \>8% * subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolon/day or equivalent. subjects inhaling glucocorticosteroids for asthma should not be excluded. * known allergy/hypersensitivity to any of the components of the investigation products. * subjects with physical and/or mental conditions that are not expected to comply with the investigation due to poor medical condition * participation in other clinical investigation(s) within 1 month prior to start of the investigation. * previously randomised to this investigation. * life expectance of the subject less than 3 months * pregnant or breast-feeding women
aron-2 study-multicentric international retrospective study

Conditions: Urothelial Carcinoma

Summary: the aron-2 study retrospectively analyze patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy. the amendment has been designed to also analyze patients treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-pd-1/pd-l1 inhibitor.


Eligibility criteria:
inclusion criteria: * patients aged \>18y * histologically confirmed diagnosis of uc of upper and/or lower urinary tract * histologically or radiologically confirmed metastatic disease * patients treated with at least one of the following: * treatment with pembrolizumab in patients progressed after previous platinum-based chemotherapy or as first-line therapy in patients platinum-unfit, and at least 1 cycle of pembrolizumab within the period from 1 january 2018 to 30 november 2021 * treatment with enfortumab vedotin in patients progressed to previous platinum-based chemotherapy and anti-pd-1/pd-l1 inhibitor and at least 1 cycle of enfortumab vedotin within the period from june 1st 2022 to july 31st 2023 exclusion criteria: * patients without histologically confirmed diagnosis of uc * patients without histologically or radiologically confirmed metastatic disease

Keywords: immunotherapy real world experience efficacy of pembrolizumab artificial intelligence technology artificial neural network
a study in healthy men to test how bi 456906 is processed in the body

Conditions: Healthy

Summary: this trial is intended to examine the basic pharmacokinetics of bi 456906 and total \[14c\]-radioactivity, including mass balance, excretion pathways and metabolism following a single subcutaneous (sc) dose of bi 456906 (c-14) in (otherwise) healthy male volunteers with normal body weight, overweight or obesity.


Eligibility criteria:
inclusion criteria: * healthy male subjects with normal body mass index (bmi) or otherwise healthy male subjects with overweight/obesity according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests * age of 18 to 65 years (inclusive) * bmi of 23.0 to 34.9 kg/m2 (inclusive); body weight of at least 70 kg. * signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (ich-gcp) and local legislation prior to admission to the trial exclusion criteria: * any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator * repeated measurement of systolic blood pressure outside the range of 90 to 140 mmhg, diastolic blood pressure outside the range of 45 to 90 mmhg, or pulse rate outside the range of 40 to 100 bpm * any laboratory value outside the reference range that the investigator considers to be of clinical relevance * any evidence of a concomitant disease assessed as clinically relevant by the investigator * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) * diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders * history of relevant orthostatic hypotension, fainting spells, or blackouts further exclusion criteria apply.
a clinical study on endoscopic and histopathological outcomes of screening and surveillance colonoscopies

Conditions: Colonic Polyp

Summary: the objective of this study is to collect colonoscopy data for use in the development and testing of artificial intelligence (ai) devices for colonoscopies.

the primary objective of this study is to collect colonoscopy data for use in the development and performance evaluation of ai devices. the data will be collected during routine colonoscopy procedures. biopsy or resection will be performed if needed and all specimens will be sent for histopathological examination. the histopathological results will be recorded.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * patients who have signed a written consent form from their voluntary decision after receiving thorough explanation on this study and fully understanding the explanation prior to participation in the study * patients who plan to receive colonoscopy procedure and meet any of the following conditions: colon cancer screening, post-polypectomy surveillance, patients who are advised by a physician to take a colonoscopy exam exclusion criteria: * patients for whom endoscopic submucosal dissection is planned * patients for whom polypectomy is difficult to perform due to antithrombotic therapy received etc. * patients who have to receive an urgent colonoscopy procedure * patients who underwent total colectomy of the large intestine * patients who are judged by a physician to be contraindicated for colonoscopy procedures * patients who have participated in another clinical study within the last 30 days
analysis of individual activity at the time of aortic rupture in patients with abdominal aortic aneurysms

Conditions: Aortic Aneurysm

Summary: it is currently unclear what activities aneurysms are involved in at the time of rupture. the aim of the study is to determine the activity performed at the time of aneurysm rupture.

the scientifically proven risk factors that significantly favor the rupture of an aortic aneurysm are female gender, the maximum diameter of the aortic aneurysm and the patient's current smoking status. however, no analysis of the occupation performed at the time of aortic rupture of an abdominal aortic aneurysm has yet been carried out. high arterial systolic blood pressure can promote aortic rupture. blood pressure peaks can occur during physical exertion, for example when lifting heavy loads or during defecation. patients with an existing intact aortic aneurysm are currently advised to avoid such behaviors as a preventive measure. this includes, among other things, the practice of strength training or certain types of sport. this can subsequently lead to a reduction in quality of life, although this cannot currently be substantiated by scientific data. there is also no current guideline recommendation in this regard. furthermore, the role of stress and / or emotionally stressful events in connection with the occurrence of aortic ruptures has not yet been recorded in the literature. there is work on this in connection with aortic dissections, which postulates that an increase in emotional or psychological stress can lead to acute hypertension, which can cause a previously damaged aorta to rupture. a similar pathomechanism would also be conceivable for the rupture of aortic aneurysms. there are indications that, in addition to gender-specific differences in the occurrence of aortic ruptures, there is also a different risk of rupture based on certain pre-existing conditions, dietary habits and age.

Eligibility criteria:
inclusion criteria: * inclusion of all patients with ruptured aortic aneurysm in augsburg university hospital * written consent to participate in the study by the patient or their legal representative exclusion criteria: * lack of consent

Keywords: aortic rupture physical stress emotional stress rupture risc follow-up activity