Kornimate/medical-research-clean huggingface dataset:
additional protein fortification in extremely low birth weight infants

Conditions: Premature Birth; Infant, Extremely Low Birth Weight; Growth Failure

Summary: postnatal growth is a crucial in premature infants as it could be correlated with the long-term cognitive development. optimal nutritional care is required to reduce the initial weight loss and further growth deficit. the quantitative objective is to achieve growth that is at least equivalent to that of the fetus (on average 15 g/kg.day (12-18 g/kg.day according to gestational age). children often grow during difficult 10-15 first days of life, so they accumulate a delay that should compensate them secondarily. therefore, optimum postnatal growth is rather 20 g/kg.day than 15 g/kg.day. individualized fortification of human milk (hm) has been proposed to optimize postnatal growth. specifically, the lack of protein intake is responsible for sub-optimal postnatal growth in preterm infants. the objectives of this study are to determine the effectiveness of additional protein fortification (apf) in terms of short-term growth along with the proportion of extremely low birth weight (elbw) infants requiring apf.

in a retrospective, single-center study, premature infants weighing \ 12 consecutive days were included. weight gain (g/kg•d) over the previous 7 days was calculated daily based on weight data in patients' electronic medical records. when weight gain was considered insufficient (i.e., below 20 g/kg•d) and the serum urea level was \<3 mmol/l, 1 g/kg•d protein was added. before using the mixture, investigators verified that the osmolality was only slightly increased (from 412 to 422 mosm/kg). growth and digestive tolerance were compared between the week before (wk0) and 1 and 2 weeks after (wk1 and wk2, respectively) the introduction of protein supplement; each participant served as his own control. change from baseline for body weight was the main outcome. energy and protein intake during wk0, wk1, and wk2 were calculated. standard deviation z-scores for growth parameters were calculated 7 days before, at time of protein introduction, and 7 and 14 days after . changes in z-scores were calculated. the digestive tolerance score and metabolic tolerance (serum urea) were assessed during wk0, wk1, and wk2 (5).

Eligibility criteria:
inclusion criteria: * infants weighing \<1250 g at birth * exclusively fed with fortified hm exclusion criteria: - severe malformations

Keywords: protein growth head circumference
bi 2536 infusional treatment in patients over 60 years of age with refractory or relapsed acute myeloid leukaemia

Conditions: Leukemia, Myeloid, Acute

Summary: the present trial will be performed to determine the mtd and to evaluate the efficacy of bi 2536 in the treatment of elderly patients with relapsed or refractory aml. different schedules will be compared to identify the better dosing schedule for the further development programme of bi 2536. dose escalation starting with the maximum tolerated dose previously determined in patients with advanced solid cancers will be performed to determine the maximum tolerated dose for aml patients.


Eligibility criteria:
inclusion criteria: * male or female patients older than 60 years of age * patient with confirmed aml (except for apl) according to the who definition who relapsed after or are refractory to prior chemotherapy * leukocyte count \<= 25,000 /mcl (25 x 10e9/liter) * patient not eligible for intensive treatment options * life expectancy \>= 2 months * eastern co-operative oncology group performance score of 2 or less * signed written informed consent consistent with international conference on harmonisation - good clinical practice (ich-gcp) and local legislation exclusion criteria: * patient with acute promyelocytic leukaemia (apl, aml of the french-american-british (fab) classification subtype m3) * hypersensitivity to the trial drug or the excipients * secondary malignancy requiring therapy * known central nervous system involvement * aspartate amino transferase (ast) or alanine amino transferase (alt) greater than 2.5 times the upper limit of normal, or ast or alt greater than 5 times the upper limit of normal in case of known liver involvement * bilirubin greater than 1.5 mg/dl (\> 26 mcmol/l, si unit equivalent) * serum creatinine greater than 2.0 mg/dl * concomitant intercurrent illness, which would compromise the evaluation of efficacy or safety of the trial drug, e.g. active severe infection, unstable angina pectoris or cardiac arrhythmia * psychiatric illness or social situation that would limit compliance with trial requirements * concomitant therapy, which is considered relevant for the evaluation of the efficacy or safety of the trial drug * chemotherapy (except hydroxyurea) or immunotherapy or treatment with any other investigational drug within the past four weeks prior to treatment with the trial drug * persistence of toxicities of prior anti-leukaemia therapies which are deemed to be clinically relevant * patients who are sexually active and unwilling to use a medically acceptable method of contraception during the trial (hormonal contraception, intrauterine device, condom with spermicide, etc.) * patient unable to comply with the protocol
a study of mhaa4549a in healthy volunteers in an influenza challenge model

Conditions: Healthy Volunteer

Summary: this randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of mhaa4549a in healthy volunteers in an influenza challenge model. subjects will be intranasally oculated with the challenge virus and will be randomly assigned to receive a intravenous dose of either mhaa4549a or placebo. in the stage 5 cohort, subjects will be randomly assigned to receive doses of mhaa4549a or placebo or tamiflu (oseltamivir) orally twice daily for 5 days. all subjects in all cohorts may take tamiflu twice daily from day 7 to day 11.


Eligibility criteria:
inclusion criteria: * in good health with no history of major medical conditions from medical history, physical examination and routine laboratory tests * male subjects and women of child-bearing potential must use effective contraception as defined by protocol, starting at entry to quarantine and continuing until day 120 follow-up visit * sero-suitable for challenge virus exclusion criteria: * women who have been pregnant within 6 months prior to the study, or who have been breastfeeding within 3 months prior to the study, or who have a positive pregnancy test at any point in the study * any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the ci * abnormal pulmonary function evidenced by clinically significant abnormalities in spirometry * history of asthma, copd, pulmonary hypertension, reactive airway disease, or chronic lung disease of any etiology. a history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment. * history suggestive of respiratory infection within 14 days prior to admission to the unit
metabolomics of the dietary approaches to stop hypertension (dash) dietary pattern

Conditions: Dietary Modification; Blood Pressure

Summary: the present record represents a secondary data analysis of the dietary approaches to stop hypertension (dash) trial. study data and specimens were accessed through the national heart, lung, and blood institute (nhlbi) biologic specimen and data repository coordinating center (biolincc). a global, untargeted, metabolomic profile was used to investigate biomarkers of the dash dietary pattern as well as blood pressure change.

the present study was conducted in order to: 1) quantify the metabolomic expression of the dash dietary pattern; and 2) examine the relationship between metabolites that reflect the dash dietary pattern and blood pressure change. this secondary data analysis leverages the completed dash trial, a randomized feeding trial (n=459).

Eligibility criteria:
inclusion criteria: * men and women with systolic blood pressure \<160 mmhg and diastolic blood pressure 80-95 mmhg exclusion criteria: * taking anti-hypertensive medication * poorly controlled diabetes mellitus * hyperlipidemia * cardiovascular event within the past 6 months * chronic disease that may interfere with participation * pregnancy or lactation * body mass index \> 35 kg/m2 * unwilling to stop taking vitamin or mineral supplements or antacids * kidney disease * consumption of \>14 alcoholic beverages per week * did not consent to the use of biological specimens * did not attend the 8 week follow-up visit * no serum specimen or insufficient volume of serum specimens in repository
accuracy of dynamic navigation and static template in completely edentulous patients

Conditions: Edentulous Jaw

Summary: the study was a prospective, multicentre, randomized parallel controlled clinical trial. randomisation was conducted by central randomisation, with random allocation codes generated by the main central computer. enrollment was conducted by competition between different centres. in this study, the coronal, apical and angular deviations (mean, standard deviation, median, quartiles, minimum, maximum, 95% confidence interval) of the static template and dynamic navigation group guided implant placement were calculated. the data is proposed to be analysed using a mixed linear effects model.


Eligibility criteria:
inclusion criteria: * 18 years old and above * american society of anesthesiologists (asa) levels 1 and 2 * satisfy any of the following requirements: 1. edentulous maxillary patients 2. edentulous mandibular patients 3. terminally edentulous maxillary patients (number of remaining natural teeth in the upper jaw 1-4) 4. terminally edentulous mandibular patients (number of remaining natural teeth in the lower jaw 1-4) 5. full-mouth edentulous patients 6. full-mouth terminally edentulous patients (number of remaining natural teeth in one jaw 1-4) * implant-supported fixed restorations or implant-supported overdenture restorations * sufficient usable bone volume at implant sites, non-implant sites (≥1.5mm of remaining bone width on the labial/buccal and palatal/lingual sides after virtual implant placement in software) * maxillary and mandibular options for full-mouth patients are based on the inclusion of more single jaws in the non-bone grafted sites (see virtual peri-implant bone volume requirements in the pre-operative preparation phase) * mouth opening of 3 fingers or more * single-jawed missing patients treated with systemic periodontal therapy exclusion criteria: * have a systemic disease that may affect prognosis (e.g. diabetic patients with glycated haemoglobin \>6.5%, patients on bisphosphonate medication, patients with auto-systemic immune diseases, etc.) * asa grades 3 and 4 * acute inflammation in the oral cavity: including uncontrolled periodontitis (periodontal probing depth \> 4 mm) and untreated acute and chronic apical periodontitis * pregnancy or breastfeeding * history of radiotherapy to the head and neck * heavy smokers (more than 10 cigarettes per day) * restricted mouth opening (less than three fingers). * participation in a clinical trial with another drug or device within 30 days prior to the start of the procedure (study day 0).
evaluation of the coloplast titan® ipp for maintaining penile length while treating erectile dysfunction (ed)

Conditions: Erectile Dysfunction

Summary: this study is designed to assess the effectiveness of the coloplast titan® inflatable penile prosthesis (ipp) at maintaining or increasing penile length after implantation of the device. it will incorporate a modified method of cylinder sizing during implantation and a max-inflate technique after implantation.


Eligibility criteria:
inclusion criteria: * has an estimated life expectancy of more than 5 years * has been diagnosed with erectile dysfunction * is willing to have the titan ipp implanted * is able and willing to complete all follow-up visits and procedures indicated in this protocol * has been informed of the nature of the study and agrees to its provisions and - has provided written informed consent as approved by the institutional review board of the respective site exclusion criteria: * participant has had a previous penile prosthesis or prior penile enlargement surgeries * participant has a compromised immune system * participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment * participant does not have manual dexterity or mental ability to operate the pump * participant has an active urogenital infection or active skin infection in region of surgery * participant is diagnosed with fibrotic disease, such as priapism or peyronie's disease * participant is diagnosed with chordee * participant has neuropathy * participant has a serious bleeding disorder or coagulopathy

Keywords: penile length ipp erectile dysfunction
a study evaluating the safety and effectiveness of the pulserider® aneurysm neck reconstruction device used in conjunction with endovascular coil embolization in the treatment of wide-neck bifurcation intracranial aneurysm

Conditions: Unruptured Wide-neck Intracranial Aneurysms

Summary: this is a prospective, multi-center, non-randomized clinical evaluation utilizing the pulserider® aneurysm neck reconstruction device.

the objective of this study is to evaluate the safety and effectiveness of the pulserider® aneurysm neck reconstruction device in conjunction with coil embolization in the endovascular treatment of unruptured wide-neck intracranial aneurysms.

Eligibility criteria:
inclusion criteria: 1. subject with wide neck intracranial aneurysm located at a bifurcation 2. the subject is between 18 and 80 years of age the time of consent 3. informed consent is obtained and the subject signs the irb approved consent prior to beginning any study procedures 4. in the opinion of the treating physician, placement of the pulserider® device is technically feasible and clinically indicated exclusion criteria: 1. unstable neurological deficit (condition worsening within the last 90 days) 2. subarachnoid hemorrhage (sah) within the last 60 days 3. irreversible bleeding disorder 4. patient has another intracranial aneurysm that in the investigator's opinion, may require treatment within the 1 year follow up period 5. a history of contrast allergy that cannot be medically controlled 6. known allergy to nickel 7. relative contraindication to angiography 8. woman of child-bearing potential who cannot provide a negative pregnancy test 9. current involvement in a study for another investigational product 10. patient and / or family considering a move from this geographical location at the time of consent 11. categorized as a vulnerable population and require special treatment with respect to safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)

Keywords: unruptured intracranial aneurysms endovascular
risk factors of neonatal thrombosis

Conditions: Thrombosis

Summary: the incidence of symptomatic thrombosis is between 2.4 and 6.8 per 1000 neonatal intensive care unit admission while it is 5.1 per 100 000 live births. compared to adults, the anticoagulant and fibrinolytic system of newborns is significantly different. in this study, the aim is to evaluate infants with neonatal thrombosis in our unit to characterize acquired and genetic risk factors, the laboratory work-up parameters and the diagnosis approach.

all newborn patients diagnosed with neonatal thrombosis in our nicu between 2014 and 2019; were included in the study. patients' data: maternal and neonatal characteristics, consanguinity, need for resuscitation, apgar scores, diagnoses, need for mechanical ventilation, sepsis, catheter placement, treatment regimens and hospital outcomes; laboratory findings: cbc; d-dimer levels and the performed genetic test thrombosis diagnosis was confirmed by imaging techniques such as ultrasonography (usg), echocardiography, and magnetic resonance imaging (mri). the genotypes: factor v (leiden) g1691a, prothrombin g20210a, mthfrc677t, mthfra1298c, pai-serpine1, factor xiii v34l mutations

Eligibility criteria:
inclusion criteria: * all newborn accepted at nicu exclusion criteria: * no

Keywords: newborn, hereditary risk factors
sequenced vs. integrated delivery of treatment for adolescent depression and sud

Conditions: Adolescent; Depression; Substance Use Disorders

Summary: the purpose of this study is to determine whether it is more effective to treat adolescents, with diagnoses of both depression and substance use disorder, with a treatment addressing the substance use first and then treating the depression or to first treat the depression and then treat the substance use or whether treating both disorders simultaneously is most effective. it is expected that treatment of both disorders at the same time will be the most effective.

comorbidity is a well established aspect of adolescent psychopathology. the majority of adolescents entering treatment have more than one condition. this study will evaluate service delivery methods of integrating empirically supported interventions for depression and non-nicotine substance use disorders (sud)in an effort to improve treatment engagement, response, and maintenance of gains. the two examined interventions are the adolescent coping with depression course (acwd) and functional family therapy (fft). this study will expand upon previous research by systematically treating both depression and sud. over a 5 year period, 180 adolescents with depression/sud and their parents/guardians will be recruited in oregon and new mexico and randomly assigned to 1 of 3 conditions: (a) fft followed by acwd, (b) acwd followed by fft, or (c) an intervention combining and augmenting fft and acwd (integrated treatment). each treatment arm will consist of 24 sessions provided over 20 weeks. participants will be assessed at intake, after the provision of 6, 12 (mid-treatment), 18 and 24 (post-treatment)treatment sessions, and at 6 and 12 month follow-ups.

Eligibility criteria:
inclusion criteria: 1. dsm-iv-tr diagnosis of depression, defined as mdd, dysthymia, or substance-induced mood disorder meeting mdd or dysthymia symptom criteria 2. dsm-iv-tr diagnosis of one or more non-nicotine sud 3. some reported illicit drug use in the last 90 days 4. 13-17 years of age 5. parent or guardian willing to participate in study 6. basic english competency (ability to converse in english) exclusion criteria: 1. current and acute suicidal ideation at the level warranting inpatient treatment 2. current psychotic symptoms 3. the adolescent's sibling is already participating in the study 4. if on psychiatric medications, a significant change in dosage levels in the prior 4 weeks -

Keywords: treatment efficacy family therapy teens substance abuse substance dependence
efficacy and safety of nvp-nk4146 in patients with mild cognitive impairment (mci) due to alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this clinical trial is to exploratively evaluate the efficacy and safety of nvp -nk4146 in improving mild cognitive impairment (mci) in patients with due to alzheimer's disease (ad) compared to placebo

36-week, single-center, randomized, double-blind, parallel-design, placebo-controlled trial

Eligibility criteria:
inclusion criteria: 1. male and female adults aged 60 or older 2. subject who meet the national institute of aging and alzheimer's associations (nia-aa) core clinical criteria for mci and have positive readings from amyloid pet 3. subject who can read and understand the informed consent form and legends and who voluntarily decided to participate in current clinical trial and have signed the informed consent form exclusion criteria: 1. subject diagnosed with dementia according to the criteria of dsm-5 or icd-10 2. subject currently receiving treatment for malignant tumors (except those who have fully recovered from cancer for more than 5 years or those with basal cell carcinoma, squamous cell carcinoma, or prostate cancer may participate at the investigator's discretion) 3. subject who are illiterate and/or without any education 4. any other factors deemed by the investigator to be likely to ineligible for the study
cti-01 (ethyl pyruvate) safety and complication prevention in cardiac surgery patients on cardiopulmonary bypass (cpb)

Conditions: Coronary Disease; Heart Valve Diseases

Summary: over 500,000 patients undergo cardiac surgery with cpb in the united states annually. although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction. the incidence of complications may exceed 30%. it has been speculated that an exaggerated inflammatory response to surgical trauma and the cpb machine are likely causes for this morbidity. factors predisposing organ dysfunction include tissue injury, endotoxemia, and oxidative stress. high risk patients can be identified preoperatively through the validated parsonnet additive risk score. cti-01 has demonstrated potent anti-inflammatory and tissue protection activity in multiple animal models of disease including pancreatitis, ischemia-reperfusion injury, sepsis, renal injury, and endotoxemia. these findings support its clinical use in critical care medicine including cardiac surgery. patients will receive a total of six doses, administered intravenously just prior to and after surgery.


Eligibility criteria:
inclusion criteria: * parsonnet additive risk score greater than or equal to 15 * scheduled cabg (coronary artery bypass grafting) and/or cardiac valve repair or replacement surgery using cardiopulmonary bypass exclusion criteria: * emergency cardiac surgery * significant concomitant surgery * minimally invasive or thoracic surgical approach * preoperative mechanical assist device * body weight \ 140 kg * active systemic infection * creatinine \>3.0 mg/dl * history of hematologic or coagulation disorders * history of malignancy (past year)or organ transplantation * use of immunosuppressive drugs or current immunosuppressed condition

Keywords: coronary artery bypass grafting heart valve prosthesis implantation cardiopulmonary bypass oxidative stress inflammation endotoxemia