Kornimate/medical-research-clean huggingface dataset:
a bridging study: comparing two lots of sci-b-vac™ and engerix-b in healthy adults

Conditions: Hepatitis B

Summary: this was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one site in vietnam whose primary objective was to demonstrate clinical equivalence of the two production lots of sci-b-vac vaccine produced at two different facilities (old facility (lot a) and new facility (lot b) with respect to anti-hepatitis b-surface (hbs) response. secondary efficacy analysis was performed to demonstrate non-inferiority of seroprotection of each lot of sci-b-vac vaccine when compared to engerix-b vaccine

this was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one site in vietnam. following a screening period, healthy eligible subjects (n = 402) were enrolled and randomized to receive sci-b-vac (old facility (lot a) and new facility (lot b), or engerix-b. the study was conducted in two stages, approximately a year-and-a-half apart. in the first stage (stage i) beginning in march 2006, sci-b-vac (lot a) vaccine was compared to engerix-b; and in the second stage (stage ii) beginning in november 2007, the sci-b-vac (lot b) vaccine was compared to engerix-b. the subjects assigned to the engerix-b group were equally divided between the stages, 67 subjects in the engerix-b group in stages i and ii, respectively, for a total of 134 subjects, such that the final number of randomized subjects in stage 1 and stage 2 across the sci-b-vac lot a, sci-b-vac lot b and engerix-b was 1:1:1, respectively. immunogenicity evaluations for stage i data (visits 5 and 6) were conducted together with stage ii data.

Eligibility criteria:
inclusion criteria: healthy adults 18 to 45 years of age who were seronegative for hbsag, anti-hbs, anti-hepatitis b core antigen, hiv, and hepatitis c virus (hcv) exclusion criteria: * evidence of alcoholism or drug abuse, history of hiv, or hcv * blood transfusions within the three months prior to inclusion in the study * uncontrolled hypertension and other cardiovascular diseases * chronic/concurrent administration (\>14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. inhaled and topical steroids were permitted * history of anaphylaxis (including shock) or any significant allergy or atopy

Keywords: sci-b-vac prophylactic vaccine hepatitis b vaccines phase 3 pre-s1 pre-s2 surface antigen 3-antigen
guided bone regeneration versus bone block grafting

Conditions: Atrophy; Bone

Summary: the purpose of this study is to analyze the volumetric gain and stability of the newly formed bone tissue comparing guided bone regeneration with block graft.


Eligibility criteria:
inclusion criteria: * patients in need of an implant-supported rehabilitation * patients requiring bone regeneration * healthy patients * full-mouth plaque score (fmps) and full-mouth bleeding score (fmbs) ≤ 15% * sufficient mesiodistal and interocclusal space * at least 6 months of follow-up exclusion criteria: * an american society of anesthesiologists physical status classification ≥ iii * general contraindications for surgical treatment or implant placement * untreated periodontitis * smoking * excessive alcohol consumption * any drug or medication known to affect oral status and bone turnover or contraindicate surgical treatment * no residual keratinized tissue at the experimental area * unwillingness to return for follow-up examinations

Keywords: bone regeneration
music therapy with intubated and sedated pediatric patients

Conditions: Respiratory Syncytial Virus Infections

Summary: the study is a randomized controlled trial of pediatric patients ages birth to two years of age who are mechanically ventilated and sedated as a result of a respiratory virus. the experimental group will receive twenty minutes of live, preferred music with a board-certified music therapist and the control group will receive twenty minutes of recorded music, also preferred, both interventions conducted at bedside. caregivers will take a pre and post survey.

data for heart rate, respiratory rate, and blood pressure will be taken for both control and experimental conditions prior to intervention, immediately following intervention, thirty minutes post, and sixty minutes post intervention. caregivers will take the parental belief scale for hospitalized children prior to intervention and 60 minutes poster intervention.

Eligibility criteria:
inclusion criteria: * patients with respiratory syntactical virus, pneumonia, rhino, corona, bronchiolitis, or flu * mechanically ventilated * sedated * patients with underlying diagnosis accepted unless listed below * patients must have a primary caregiver present exclusion criteria: * patients who are oscillating * have a previous diagnosis of severe or profoundly deaf * have a suspicion of child abuse * in custody of the state.
improving care for patients with chronic kidney disease using emrald

Conditions: Chronic Kidney Disease

Summary: this pragmatic cluster randomized controlled trial will test the impact of feedback and a toolkit aimed at improving the management of chronic kidney disease (ckd) in the primary care setting. this trial will use family physicians in ontario participating in the electronic.

this trial will use family physicians in ontario participating in the electronic medical record administrative data linked database (emrald) and receiving the system for audit and feedback to improve care (safire) along with other decision support tools. performance on ckd quality indicators for family physicians receiving the ckd feedback and tools will be compared to physicians not receiving the ckd feedback or tools.

Eligibility criteria:
inclusion criteria: * family physicians participating in emrald, on the emr for \>=2 years, roster size \>=100 patients * patient criteria, rostered and actively seeing an emrald physician, on the emr for .=1 year exclusion criteria: * updated data available at the time of study commencement
drinking water pfas, pregnancy outcome and maternal morbidity

Conditions: Birth Weight; Small for Gestational Age at Delivery; Large for Gestational Age at Delivery (Macrosomia); Diabetes, Gestational; Hypertension in Pregnancy; Preeclampsia; Congenital Malformation

Summary: the aim of the project is to assess the association between exposure to per- and polyfluoroalkyl substances (pfas) via drinking water in pregnancy and birth outcomes (i.e. growth retardation, premature birth, and congenital developmental defects) and maternal morbidity (gestational hypertension, diabetes and preeclampsia) in a prospective population-wide register study.


Eligibility criteria:
inclusion criteria: * pregnant women residing in swedish localities with a population exceeding 10,000 inhabitants and giving birth during 2012-2018 exclusion criteria: * lack of data of pfas levels in municipal drinking water (entire localities excluded) * mothers not living in the study area consistently between first trimester and four years prior to birth
the effect of fatigue on the clinical performance

Conditions: Fatigue

Summary: the primary aim of this randomized controlled trial is to examine the effect of fatigue on clinical performance in a simulated obstetric emergency. this scenario was chosen because it is a common clinical situation faced by anesthesia providers on call and therefore likely to occur when a provider is fatigued. secondary outcomes will include the evaluation of other factors that worsen fatigue related decrement in performance including age, years of training/practice and clinical load prior to study participation.


Eligibility criteria:
inclusion criteria: * all attending anesthesiologists taking overnight call at evanston hospital will be eligible participants. exclusion criteria: * resident physician or trainee, physician not taking overnight in house call.

Keywords: human performance clinical performance
a multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (cbus)

Conditions: Hematologic Malignancies; Inherited Disorders of Metabolism; Inherited Abnormalities of Platelets; Histiocytic Disorders; Acute Myelogenous Leukemia (AML or ANLL); Acute Lymphoblastic Leukemia (ALL); Other Acute Leukemia; Chronic Myelogenous Leukemia (CML); Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases; Other Leukemia; Hodgkin Lymphoma; Non-hodgkin Lymphoma; Multiple Myeloma/ Plasma Cell Disorder (PCD); Inherited Abnormalities of Erythrocyte Differentiation or Function; Disorders of the Immune System; Autoimmune Diseases; Severe Aplastic Anemia

Summary: this study is an access and distribution protocol for unlicensed cryopreserved cord blood units (cbus) in pediatric and adult patients with hematologic malignancies and other indications.

principal investigators: the principal investigators (pis) will be transplant physicians at all participating u.s. transplant centers. study design: this study is an access and distribution protocol for unlicensed cryopreserved cord blood units (cbus) in pediatric and adult patients with hematologic malignancies and other indications. primary objective: the primary objective of this study is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using cbus that are not food and drug administration (fda) licensed. secondary objectives: in patients receiving a non-licensed cbu: * assess incidence of transmission of infection * assess incidence of serious infusion reaction * determine 1 year overall survival after cord blood transplantation * assess cumulative incidence of acute graft vs. host disease (gvhd) grades ii to iv and grades iii to iv * assess cumulative incidence of chronic gvhd * determine platelet engraftment of \>20,000 mcl and \>50,000 mcl

Eligibility criteria:
inclusion criteria: * disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment * signed informed consent (and signed assent, if applicable) obtained prior to study enrollment * pediatric and adult patients of any age exclusion criteria: * patients who are receiving only licensed cbus * cord blood transplant recipients at international transplant centers * patients who are enrolled on another ind protocol to access the unlicensed cbu(s) * patients whose selected unlicensed cbu(s) will be more than minimally manipulated
differentiate avnrt from orthodromic avrt

Conditions: SVT

Summary: to study new maneuvers to differentiate avnrt from orthodromic avrt including va interval variability at tachycardia induction, sa-va base and local va index (difference between local va interval, measured on the coronary sinus catheter during tachycardia and entrainment, at the site of earliest atrial activity).

the differentiation of atrioventricular nodal reentrant tachycardia (avnrt) from atrioventricular reciprocating tachycardia (avrt) as well as the localization of accessory pathways (aps) is necessary to guide the catheter ablation of supraventricular tachycardia (svt). however, existing techniques may prove challenging in differentiating atypical forms of avnrt from avrt using a septal ap; or localizing avrt with different septal ap insertion sites. there are many diagnostic maneuvers during electrophysiological study eg ventriculo atrial interval (va) during tachycardia, postpacing interval tachycardia cycle length (ppi-tcl) and stimulus atrial ventriculaoatrial interval (sa-va). it is important to recognize that as with most diagnostic tests, no single observation or maneuver is 100% sensitive or specific. therefore, it is important to obtain data from multiple observations and maneuvers to verify the diagnosis. also, utility of these techniques usually depends on the tachycardia to be sustained, however sometimes tachycardia is rapidly terminating. va interval at initiation of tachycardia is usually variable and becomes fixed after several beats. this may be explained by differences in retrograde conduction between avrt and avnrt which may be better exposed at the time of tachycardia induction, so measuring the number of beats until va becomes fixed may theoretically help in differentiating avnrt from avrt. although several reports have demonstrated the usefulness of the sa-va using right ventricular (rv) apical stimulation (sa-vaapex) to distinguish avnrt from avrt, there remains significant overlap in the sa-va complicating the distinction between these 2 arrhythmias. theoretically, stimulation from the rv basal septum (sa-vabase) would be expected to shorten the sa interval in avrt because atrioventricular pathways insert in the ventricular base. on the other hand, the sa-vabase should have the opposite effect on avnrt because the impulse must first pass from the rv base to the apex to access the right bundle.

Eligibility criteria:
inclusion criteria: * all patients with documented narrow complex supraventricular tachycardia presented to electrophysiology lab including all age and sex patients (in assiut university cath. lab) and proved to be avnrt or orthodromic avrt. exclusion criteria: 1. atrial tachycardia 2. atrial flutter. 3. atrial fibrillation. 4. manifest preexcitation on surface ecg -

Keywords: avnrt - orthodromic avrt
a study of single dose mk-3614 (mk-3614-001)(completed)

Conditions: Hypertension

Summary: this study will determine if mk-3614, given as single doses, is safe and well tolerated in healthy males and male participants with mild to moderate hypertension.

up to three planned panels of either 8 healthy participants (panels a and b) or 8 participants with mild to moderate hypertension (panel c) will be enrolled. in panels a and b, 8 participants will alternately receive single rising doses of mk-3614 or placebo. all doses will be administered in the fasted state, except panel a, period 3 in which a standard high-fat breakfast provided approximately 30 minutes prior to dosing. panel a will begin first. at least 3 days will elapse before participants in the alternate panel (panel b) will receive the next higher dose. in panel c, 8 mild to moderate hypertensive male participants will receive single rising doses of mk-8892 or placebo. for all panels, there will be at least 7 days washout between treatment periods for any given participant. participants may only be enrolled in one panel of the study. all participants in periods of all panels (with exception of 0.25 mg fasted/fed periods) will be randomly assigned to either study drug or placebo, i.e., a participant could be assigned to receive study drug in one period and placebo in another. as per the protocol allocation plan, the same participants will receive 0.25 mg mk-3612 in a fasted and fed state.

Eligibility criteria:
inclusion criteria: * healthy participants between 18 to 45 years of age; otherwise healthy participants between 18 to 55 years of age newly diagnosed with grade 1 or 2 hypertension * participant is in good general health * participant is a nonsmoker exclusion criteria: * participant has a history of stroke, seizure or major neurological disease * participant has functional disability that can interfere with rising from a sitting position to a standing position * participant has a family history of a bleeding or clotting disorder * participant has a history of cancer * participant is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study * participant consumes excessive amounts of alcohol or caffeine * participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks.
[18f]av45(aβ) and [18f]av1451(tau)pet/ct in the diagnosis of early pathological changes of alzheimer's disease

Conditions: Alzheimer's Disease

Summary: to investigate the primary brain regions of precursors of alzheimer's disease and alzheimer's disease by novel molecular probe \[18f\]av45(aβ) and \[18f\]av1451(tau)pet/ct imaging. and the distribution of positive lesions in the brain area affecting the simple mental state examination and the montreal cognitive assessment scale in ad patients; it is expected to provide molecular imaging information for further study of the pathogenesis of ad. after clinical transformation, objective and quantitative positive diagnostic criteria for \[18f\]av45 and \[18f\]av1451pet/ct in the diagnosis of early alzheimer's disease were established to avoid the defects of relying on the subjective experience of doctors and time-consuming diagnosis.


Eligibility criteria:
inclusion criteria: * meet the mci diagnostic criteria of peterson in 2004; * the clinicaldementiarating scale (cdr) score was 0.5; * prominent memory loss may also be accompanied by impairment of other cognitive domains; * insidious onset and slow progression; * not at the level of dementia. ad entry criteria: * meet the criteria for diagnosing dementia as described in the fourth edition of the diagnostic and statistical manual of mental disorders (dsm-iv-r), use the diagnostic criteria for ad from the national institute of neurology, speech and communication disorders and stroke - alzheimer's disease and related disorders (nincds-adrda) or the national institute on aging and alzheimer's disease association (nia-aa). * clinical dementia rating scale score was 1 point. exclusion criteria: * patients with a history of stroke and focal neurological signs, and imaging findings consistent with small cerebral vascular disease (fazekas score ≥2); * the presence of other neurological disorders that can cause brain dysfunction (e.g., depression, brain tumors, parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal facial pressure hydrocephalus); * the presence of other systemic diseases that can cause cognitive impairment (such as liver insufficiency, renal insufficiency, thyroid dysfunction, severe anemia, folic acid or vitamin b12 deficiency, syphilis, hiv infection, alcohol and drug abuse, etc.); * there is mental and neurological retardation. * there are other diseases that are known to cause cognitive impairment.
effects of recruitment manouever on oxygenation, oxygen reserve index and postoperative pulmonary complications

Conditions: Obesity; Bariatric Surgery Candidate

Summary: general anesthesia and mechanical ventilation decrease pulmonar volume; attenuate small airway closure, atelectasis, and increase the rate of hypoxia and postoperative pulmonary complications. lung volume in obese patients decreases inversely with the increase in body mass index. obesity is associated with increased atelectasis, hypoxia and postoperative pulmonary complication rates during anesthesia . alveolar recruitment maneuver is a technique where high positive end-expiratory pressure (peep) is applied for for short periods, follwed by a continuous peep appşication throughout surgery. this has become a standard practice during anesthesia in recent years. oxygen reserve index (ori) is an index measured with a non-invasive finger-tip sensor and shows the oxygen content of the venous blood. it is effective at high oxygen levels and may indicate the presence of hyperoxia. our aim is to examine the effect of alveolar recruitment maneuver on oxygenation parameters under anesthesia and the correlation with ori in morbidly obese patients.

patients with body mass index\> 40 m2, scheduled for bariatric surgery under general anesthesia will be monitorised with the ori sensor and monitored at regular intervals. preoperative and postoperative lung aeration will be evaluated with lung ultrasaund. i̇ntraoperative standart anesthesia will be administered by an anesthesiolıgist not aware of the ultrasound. alveolar recruitment will be applied by the same anesthesiologist if necessary. blood gas samples obtained throughout surgery will be evaluated. ori̇ values and intraoperative vital, respiratory, neuromuscular monitoring parameters will be obtained. postoperative pulmonary complicationsa will be evaluated at postoperative day 5. finding will be compared between patients who received recruitment and who did not.

Eligibility criteria:
inclusion criteria: bariatric surgery general anesthesia and mechanical ventilation via orotracheal entubation age between 18-65 asa i-iii bmi \> 40 m-2 exclusion criteria: previous history of thorasic surgery, pneumothorax chemo or radiotherapy to the chest within 2 months history of respiratory disease (copd, emphysema, pneumonia, lung malignancy, lung bulla ) emergency surgery cardiovascular, renal, hepatic, neuromuscular disease i̇ntracrabial pathology or trauma high intraoptic pressure pulmonary hypertension pregnancy criticall illness, or history of mechanical ventilation within 1 month

Keywords: obesity, bariatric surgery, alveolar recruitment, oxygen reserve index
pharmacokinetic study of esomeprazole magnesium in patients 1 to 11 years-old with endoscopically-proven gastroesophageal reflux disease (gerd)

Conditions: Endoscopically-Proven GERD; Reflux

Summary: the purpose of this study is to determine the area under the plasma concentration-time curve (auc) of esomeprazole after single oral doses of 5 mg, 10 mg or 20 mg esomeprazole in pediatric patients 1 to 11 years-old inclusive with endoscopically-proven gerd.


Eligibility criteria:
inclusion criteria: * patients must be able to take solid or bland food (eg, applesauce). * patients must weigh at least 8 kg and at the investigator's discretion be able to undergo extraction of an adequate volume of blood. * the patient's weight for height percentile should be less than the 90th percentile and/or the bmi must be between the 5th and 85th percentile for age. * patients must be diagnosed with endoscopically-proven gerd exclusion criteria: * use of any other investigational compound or participation in another clinical trial within 28 days prior to the screening visit. * history or presence of gastrointestinal, hepatic or renal disease or other conditions that could interfere with absorption, distribution, metabolism or excretion of esomeprazole. * unstable diabetes mellitus or history of seizure disorder. * any acute or chronic illness or a medical history, which in the opinion of the investigator and/or sponsor, could compromise the patient's safety or successful participation in the study.

Keywords: children reflux gerd pediatric