Kornimate/medical-research-clean huggingface dataset:
early protein supplementation in extremely preterm infants fed human milk

Conditions: Prematurity; Extreme; Feeding Disorder Neonatal; Breast Milk Expression; Growth Failure; Microbial Colonization

Summary: the central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (ffm)-for-age z scores and promote maturation of the gut microbiome at term corrected age.

masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a protein-enriched diet (intervention group) or a usual diet (control group) within the first 96 hours after birth.

Eligibility criteria:
inclusion criteria: * gestational age ≤ 28 weeks of gestation * postnatal age \< 96 hours exclusion criteria: * congenital malformations * chromosomal anomalies * terminal illness needing to limit or withhold support
risk factors and outcomes of hospital acquired aki

Conditions: AKI - Acute Kidney Injury

Summary: the aim of the study is to assess the common risk factors for development of hospital acquired acute kidney injury among hospitalized patients in alexandria main university hospital and their outcomes.

hospital-acquired aki (haaki) is defined as acute renal insult occurring 48 hours or more after admission to a health care facility and it is estimated to occur in 13-18% of hospitalized patients. the early diagnosis of haaki reflects on improvement in morbidity and mortality rates especially in developing countries which goes parallel with the goal the international society of nephrology (isn) to eliminate preventable or treatable deaths from aki by 2025, the "0 by 25" initiative. data concerning the spectrum of acute kidney injury (aki) in egypt are generally scarce.

Eligibility criteria:
inclusion criteria: 1. fulfilment of definition of acute kidney injury according to kdigo reference. 2. age more than 18 years. exclusion criteria: 1. mentally or physically unfit patients. 2. patients who developed acute kidney injury within 48 hours of admission to hospital.

Keywords: aki hospital acquired risk factors outcomes
clinical efficacy of 0.75% boric acid gel in chronic periodontitis

Conditions: Chronic Periodontitis

Summary: the purpose of the present study was to evaluate the effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing in chronic periodontitis (cp) patients.

background: the purpose of this double-masked, randomized, controlled clinical trial was to evaluate the effects of subgingival delivery of boric acid gel as an adjunct to scaling and root planing (srp) on clinical and radiographic parameters and compare this method with srp plus placebo gel alone in with chronic periodontitis (cp) patients. methods: thirty nine systemically healthy patients with cp are included in this study. they were divided into two groups: 1) srp + 0.75% boric acid gel (ba group); 2) srp + placebo gel (placebo group). at baseline, 3 month, and 6 months after treatment, clinical measurements, including plaque index (pi), modified sulcus bleeding index (msbi), probing depth (pd), clinical attachment level (cal) and radiographic parameters intrabony defect depth (ibd), percentage change in radiographic defect depth reduction (ddr%) were assessed.

Eligibility criteria:
inclusion criteria: * systemically healthy with deep pockets (pd of ≥5mm or cal ≥4mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs * patients with ≥20 teeth with no history of periodontal therapy in the preceding 6 months nor under any antibiotic therapy exclusion criteria: * patients on systemic boron therapy * known or suspected allergy to boron supplementation * patients with aggressive periodontitis * tobacco use in any form, smokers, alcoholics * immunocompromised and systemically unhealthy patients * pregnant or lactating females
therapeutic treatment with human papillomavirus quadrivalent vaccine for recurrent respiratory papillomatosis

Conditions: Recurrent Respiratory Papillomatosis

Summary: the purpose of this study is to determine if administration of the hpv quadrivalent vaccine in patients diagnosed with rrp has a therapeutic effect on their clinical course. more specifically, does administration of the vaccine decrease the size and number of papillomas, severity of disease (i.e. hoarseness, inspiratory vs. biphasic stridor, airway obstruction) using the lcas and time interval between required surgical debulking will be analyzed.

patients who carry the diagnosis of recurrent respiratory papillomatosis (rrp) will be asked to participate in the study. these patients have been followed by the faculty investigator for several years. their disease state requires frequent interventions aimed at decreasing the severity and symptomatology of their vocal fold papillomas. patients will be given the human papillomavirus quadrivalent vaccine and their clinical course will be followed over the next 6 months. patients will have a laryngoscopic examination prior to treatment to establish their baseline disease state. they will have repeat laryngoscopic examinations at the time of the first, second and third vaccine injections, which will be given 1 month intervals for a total of 3 doses. they will have physical exam and laryngoscopic examinations at 1 month intervals for the first 6 months after administration of the vaccine. the severity of their clinical disease will be objectively measured using a validated scale for rrp assessment, the laryngoscopic and clinical assessment scale (lcas).

Eligibility criteria:
inclusion criteria: * there are 9 participants currently being followed in the faculty sponsor's clinic that carry the clinical and histologic diagnosis of rrp. the 9 participants meet one or more of the following criteria: surgery requirement of more than 4 procedures per year, distal multisite spread of disease, and rapid regrowth of papilloma disease with airway compromise. exclusion criteria: * if any of the 9 patients meet the following criteria they will be excluded from the study: * pregnancy * hypersensitivity or allergy to vaccine components (i.e. saccharomyces cerevisiae yeast) * immunocompromised patients (i.e. patients with hiv, cancer, or who take immunosuppressant medications including all forms of steroids) * have a fever over 100°f (37.8°c) * moderate or severe acute illness (with or without fever) * coagulopathies * platelet counts of less than 100,000 * any history of recent treatment(within 3 months) with any investigational drug or other adjuvant rrp therapy (including interferon-gamma, ribavirin, acyclovir, cidofovir and photodynamic therapy, indole-3-carbinol)

Keywords: rrp recurrent respiratory papillomatosis hpv vaccine hpv
the influence of local bone status on complications after surgical treatment of distal radius fractures

Conditions: Distal Radius Fractures; Poor Bone Quality; Treatment Complications

Summary: the purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with distal radius fractures treated with open reduction and locking compression plates(lcp).

despite fractures of the wrist being widely regarded as "fragility fractures", there is good evidence that they are caused by diminished bone mineral density (bmd) and that a low bmd value predicts a higher fracture risk at the distal radius. both measurements of areal bmd with dxa and volumetric bmd with peripheral quantitative computer tomography (pqct)showed a lower bmd in women with colles' fractures. thus, colles' fractures can be recognized as a good indication of underlying osteoporosis. high resolution peripheral quantitative computer tomography at the distal radius will be evaluated in a subset of patients. clinical experts are concerned that osteoporosis increases the risk for poor outcomes and complication rates in surgical patients with osteoporosis. however, this has not yet been confirmed in clinical studies. it is important to investigate this question in order to correctly advise clinicians and patients and possibly develop tailored approaches for treatment of osteoporotic patients with distal radius fractures.

Eligibility criteria:
inclusion criteria: * radiologically confirmed closed fracture (within 7 days) of the distal radius * primary fracture treatment with a volar lcp 2.4 mm * age equal greater 50 and equal younger 90 years * willing and able to give written informed consent to participate in the study * willing and able to participate in the study follow-ups according to the cip * willing and able to comply with the post-operative management program * able to understand and read country national language at an elementary level exclusion criteria: * fracture of ulna (except an associated fracture of the ulnar styloid process) * open distal radius fracture * concomitant contralateral radius fracture * previous distal radius fracture on either side after the age of 25 years * time to operation \> 7 days * polytrauma * regular systemic therapy with corticosteroids due to chronic disease * legal incompetence * patient received radio- or chemotherapy prior to, during, or within the last year * currently active cancer * recent history of substance abuse (i.e recreational drugs, alcohol) * prisoner * currently involved in a pharmaceutical study * has a disease process that would preclude accurate evaluation (e.g. neuromuscular or rheumatic disease, significant psychiatric or metabolic disorders)

Keywords: radius fracture adverse effects wrist postoperative complications colles' fracture intraoperative complications osteoporosis dual-energy x-ray absorptiometry (dxa) bone density
emergency department targeted ultrasound for the detection of hydronephrosis

Conditions: Urolithiasis; Ultrasonography; Hydronephrosis

Summary: an emergency department targeted ultrasound (edtu) is an ultrasound examination performed by an emergency department physician, instead of a radiologist or ultrasound technician. edtu is intended to be a readily assessable test performed at the bedside, to quickly and safely determine the presence of a disease state; it answers a binary question, as compared to formal ultrasound imaging which seeks to determine the cause of a patient's symptoms. the objective of this study is to determine the accuracy of edtu in patients suspected of renal colic. by demonstrating excellent test characteristics, these investigators hope that this research will be used to incorporate edtu for hydronephrosis into standard emergency care in canada.


Eligibility criteria:
inclusion criteria: * emergency department patients * males and females * age 16-65 * undergoing ct scan of the abdomen or formal ultrasound of the abdomen at kingston general hospital or hotel dieu hospital in kingston, ontario. exclusion criteria: * hemodynamic instability * fever * leukocytes or nitrites on dipstick urinalysis * pregnancy * renal failure * single functioning kidney or renal transplant

Keywords: urolithiasis ultrasound hydronephrosis
treatment of high risk adult acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: current therapeutic protocols for adult all consider mrd together with the baseline risk factors (age, wbc count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. on the other hand, the systematic use of allogeneic sct for all adult patients (pts) with ph- hr-all is still a matter of debate. the aim of the prospective study all-ar-03 from the spanish pethema group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic sct) according to early bone marrow blast clearance and mrd levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in hr ph- adult all patients.

hr all included one or more of the following baseline parameters: age 30-60 yr, wbc count \>25x109/l and 11q23 or mll rearrangements. induction therapy included vincristine, prednisone and daunorubicin for 4 weeks. in pts with slow cytologic response to therapy (≥10% blasts in bone marrow assessed on d14) intensified induction with high dose ara-c and mitoxantrone was administered. early consolidation therapy included 3 cycles with rotating cytotoxic drugs including high-dose methotrexate, high-dose ara-c and high-dose asparaginase. pts. with slow cytologic response on d14 or mrd level \>0.05% after consolidation were assigned to allogeneic sct (related or unrelated) and those with standard cytologic response on d14 and mrd level \<0.05% after consolidation received 3 additional cycles of delayed consolidation (identical to those of early consolidation) followed by maintenance therapy up to 2yr in cr.

Eligibility criteria:
inclusion criteria: * high risk all adult patients (age\> 15 years)no treated previously * high-risk all: * one or more of the following: * age 30-60 yr. * wbc count \>25x109/l * 11q23 or all1/af4 * very high-risk all: * hr all and one or the following: * slow cytologic response (\>10% blasts in bm on d14 of induction therapy). * mrd\>0.05% (by flow cytometry) at the end of consolidation exclusion criteria: * l3 all or b mature(sig +) or t(8;14), t(2;8), t(8;22). * all ph (bcr/abl) positive. * bifenotipics all as egil criteria. * indifferentiated all. * patients with cardiac pathology * patients with chronic liver disease in activity fase * pulmonary disease * renal insufficiency not due to all * neurological disorders not due to all * ps (grades 3 and 4) not due to all.

Keywords: acute lymphoblastic leukemia high-risk (hr) philadelphia chromosome-negative
default bp medication intensification

Conditions: Hypertension

Summary: high blood pressure leads to heart attacks and strokes which can be prevented by blood pressure-lowering medication. however, the current office-based prescription of one pill and one dose at a time is ineffective. the investigators want to pilot-test a more effective patient-centered treatment approach, where patients will receive a prescription with gradual but automatic weekly increases of dose and number of pills. patients will measure their blood pressure with an iphone compatible cuff, which transmits readings to the doctor or pharmacist, who will stop escalation when the desired blood pressure level is reached. the investigators hypothesize that the intervention will decrease the time to control blood pressure and increase the overall rate of blood pressure control. therefore, this new treatment model could prevent heart attacks and strokes, and reduce healthcare costs.

this is a pilot 2a trial of an innovative behavioral economics theory-based antidote for physician inertia in the medical treatment of hypertension (htn). in the current reactive physician-centered model, blood pressure (bp) is measured and medical decisions are made in the physician office; when deciding whether or not to prescribe new medication for a high office bp reading, the physician's default behavior is inaction. the investigators propose default medication intensification as a new patient-centered/pharmacist-assisted proactive treatment model to eliminate physician inertia. for enrolled patients with office bp\>155/95, the physician will prescribe a one-month protocol that automatically escalates drug dose and drug number each week. the pharmacist will fill the prescription in a blister pack to simplify adherence. the patient will measure daily home bp with an iphone cuff that transmits the data electronically to the pharmacist, who will halt the protocol if goal home bp\<135/85 is achieved ahead of schedule. the investigators will pilot test the feasibility and safety of self-monitoring plus the new automatic intensification protocol packaged in blisters. default medication intensification could revolutionize htn treatment and reduce healthcare costs.

Eligibility criteria:
inclusion criteria: * 18 to 55 years old * office bp of ≥160 mmhg systolic and ≥100 mmhg diastolic (treated or untreated) and \<180 mmhg systolic. exclusion criteria: * chronic kidney disease * symptomatic coronary artery disease * congestive heart failure * more than mild valvular heart disease * diabetes mellitus * obstructive left ventricular hypertrophy * severe electrolyte abnormalities * multiple medication intolerances * orthostatic hypotension * cognitive impairment and mental disorders affecting ability to self-monitor bp * patients who are unwilling to measure and transmit bp readings throughout the study

Keywords: physician inertia hypertension telemedicine mobile technology
aripiprazole for the treatment of schizophrenia with co-morbid social anxiety

Conditions: Schizophrenia; Schizoaffective Disorder; Social Anxiety Disorder

Summary: this study will determine the efficacy of a medication switch to aripiprazole for the treatment of schizophrenia or schizoaffective disorder in patients with moderate to high symptoms of social anxiety. specifically the study will test the possibility that a medication switch to aripiprazole reduces symptoms of social anxiety in this patient population.

although research has shown that social anxiety is very common among patients suffering from schizophrenia or schizoaffective disorder, it is rarely diagnosed and treated in this patient population. this study will determine the efficacy of a medication switch to aripiprazole for the treatment of schizophrenia in patients with moderate to high symptoms of social anxiety. specifically the study will test the possibility that a medication switch to aripiprazole reduces symptoms of social anxiety in this patient population. in addition, the study will test the possibility that aripiprazole significantly improves social adjustment, quality of life and level of functioning in these patients. the study may also assess the ability of aripiprazole to reduce sexual dysfunction.

Eligibility criteria:
inclusion criteria 1. patients meeting dsm iv diagnostic criteria for schizophrenia or schizoaffective disorder. 2. patients presenting with comorbid social anxiety symptoms of moderate to high severity are eligible for participation in the study. only patients with lsas scores above 30\* qualify for the study. 3. age 18-65 4. gender: males or females 5. females: non-pregnant, not of child-bearing potential; if of child-bearing age must be on contraceptive such as pill or shot (condom alone not sufficient) 6. good general health exclusion criteria: 1. patient does not meet dsm iv diagnostic criteria for schizophrenia or schizoaffective disorder 2. patient carries a diagnosis of dementia, degenerative cns disorders, mental retardation, substance abuse or dependence other than nicotine dependence or alcohol abuse will be excluded from the study. 3. patients with acute medical conditions are not eligible. 4. patients allergic or otherwise intolerant or non-responsive to aripiprazole 5. patient with history of suicidal, homicidal or assaultive plans or attempts in the past 6 months. 6. clinically significant ekg or lab abnormalities

Keywords: schizophrenia schizoaffective disorder social anxiety disorder
extracellular rna biomarkers of duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. the investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. the purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample.


Eligibility criteria:
inclusion criteria: * subjects with dmd or bmd based on genetic testing. control subjects are unknown to have any other muscular dystrophy by history and may have had no genetic testing. * able to provide informed consent or assent for participation in the study. * demographic characteristics for biofluid collection: males age 5 years and older with dmd or bmd; males and females ages 18 years and older without muscular dystrophy. exclusion criteria: * medical history of any of the following: state of immunosuppression; coagulopathy; pre-existing liver or kidney disease; documented hiv positive; documented hepatitis b and/or c positive. * use of anti-platelet drugs within 7 days prior to blood draw; use of anticoagulants within 60 days prior to blood draw. * inability or unwillingness of the subject to give written informed consent.
stimulation parameters and non-motor symptoms in pd treated with dbs

Conditions: Parkinson Disease

Summary: this study evaluates the role of subthalamic nucleus (stn) stimulation location and frequency on a range of cognitive processes in parkinson's patients who have undergone deep brain stimulation (dbs).

pre- and post- dbs implantation brain scans will be reviewed by the study team to see if patients' dbs settings can be personalized. if so, study subjects will undergo adjustments to their dbs settings and be asked to perform cognitive tests. some patients will be asked to come back for a second visit for brain scans.

Eligibility criteria:
inclusion criteria: 1. between 40 and 70 years of age, 2. ability to provide informed consent, 3. clinical diagnosis of idiopathic parkinson disease (pd) by a movement disorders neurologist, 4. disease duration of at least 4 years, 5. treated with bilateral stn dbs for at least 3 months prior to study enrollment. exclusion criteria: 1. history of prior neurosurgical intervention for pd (e.g., dbs, thalamotomy, pallidotomy) 2. history of other central nervous system disease (excluding migraine), 3. presence of active psychiatric symptoms meeting diagnostic and statistical manual of mental disorders-4th edition (dsm-iv) criteria for axis-i disorder on formal psychiatric evaluation, with the exception of mild depression (beck depression inventory-2 score below 19), 4. cognitive impairment meeting diagnostic and statistical manual of mental disorders-4th edition (dsm-iv) criteria for dementia on formal neuropsychological evaluation, 5. current alcohol or substance abuse, 6. lack of fluency in english which would invalidate cognitive testing, 7. hearing or visual impairment precluding cognitive testing. exclusion criteria for day 2 procedures: 8. inability to safely undergo mri procedure (i.e., metal objects like prostheses, pacemakers)