Kornimate/medical-research-clean huggingface dataset:
microalbuminuria in children with and without diabetes

Conditions: Diabetes Mellitus

Summary: the purpose of the study is to learn more about microalbuminuria in children with and without diabetes. albumin is a protein that may be excreted in the urine. in some conditions, like kidney problems or diabetes, the amount of albumin in the urine increases. the purpose of this study is to measure concentration of albumin in the urine of diabetic children and compare to healthy children.

diabetic nephropathy is a known cause of significant morbidity and mortality in adult patients with diabetes. microalbuminuria (ma) is predictive of future diabetic nephropathy (dn) in adult patients with diabetes mellitus (dm). this link between ma levels and dn allows patients to receive timely interventions. the predictive value of ma for dn in children with dm, however, is not well established. most studies looking at this association in children have only been forced to use adult ma values. children, particularly adolescents, are known to have different normal values for 24-hour total protein excretion compared to adults and it may be that they also have different normal levels of ma. little literature exists on normal levels of 24 hr ma in healthy children and in children with diabetes. in this study, we seek to define the range of ma levels that falls between the 2.5 and 97.5 percentiles for children with and without dm. once these values are established, we will have a foundation for further studies to define which, if any, ma values are predictive of dn in children. if we can establish a ma level which is predictive of dn in children, it will allow physicians to direct medical intervention at those most likely to benefit while protecting others from unnecessary medications, procedures, and risks.

Eligibility criteria:
inclusion criteria: * healthy children 6 to 18 * diabetic children 6 to 18 exclusion criteria: * kidney disease * abnormal body temperature * history of documented urinary tract infection * metabolic disease other than diabetes mellitus * circulatory disease * liver disease * strenuous exercise in prior 24 hours * nocturnal enuresis
double-blind placebo-controlled study comparing the combination of 15% sp-303 gel with acyclovir versus acyclovir alone for the treatment of recurrent herpes simplex virus (hsv) infections in subjects with acquired immunodeficiency syndrome (aids)

Conditions: Herpes Simplex; HIV Infections

Summary: to evaluate the safety of topically applied sp-303 gel and to compare the efficacy of sp-303 gel in combination with acyclovir, relative to acyclovir alone, for the treatment of recurrent herpes simplex virus (hsv) 1 and 2 infections, affecting the genital, perianal and neighboring areas, in patients with aids.

this trial is a double-blind, multicenter, placebo-controlled clinical trial. participants are randomized to topical 15% sp-303 gel and oral acyclovir or to matching topical placebo gel and oral acyclovir. at presentation, patients are stratified by total lesion area within each treatment group. sp-303 or matching placebo is topically applied three times a day until all lesions are reepithelialized or for 14 days, whichever occurs earlier. acyclovir is administered by mouth each day, three times a day, until all lesions are reepithelialized or for 14 days, whichever occurs earlier. patients are evaluated for lesion healing and adverse events 3 times per week during the treatment period. the primary efficacy endpoint will be complete lesion healing and the primary analysis will be time to complete healing.

Eligibility criteria:
inclusion criteria patients must have: * aids, according to the cdc criteria. * documented recurrent (at least 1 prior episode) perineal (genital, perianal and neighboring areas) mucocutaneous herpes simplex virus (hsv) types 1 or 2 infection in the active phase. * duration of current episode of recurrent hsv lesions of 3 days or less. * ability to read and write, must be intellectually competent, and able to understand the purposes and risks of the study. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * active internal anal or rectal herpes. * inability to comply with protocol. * impaired renal function. patients with the following prior conditions are excluded: * prior episode of recurrent genital herpes infection with documented clinical failure of acyclovir as a treatment regimen. * uncompensated hepatic, cardiac, or renal failure within 1 month of the study. * history of hypersensitivity to acyclovir. * previous enrollment in this study. 1. treatment with another medication (topical, oral, or intravenous) with known anti-hsv activity within the past 5 days. * systemic immunomodulatory therapy within 30 days prior to study. * previous treatment with sp-303. required: unchanged antiretroviral therapy for the 2 weeks prior to study.

Keywords: aids-related opportunistic infections herpes simplex drug therapy, combination acyclovir antiviral agents gels sp 303
treatment of anemia with epoetin beta in low risk myelodysplastic syndrome (mds)

Conditions: Myelodysplastic Syndromes

Summary: chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic syndrome. it generates an increased rate of morbidity and mortality in this population of patients whose median age is high and the rate of co-mobidities important. the historical treatment is limited to transfusion support with a significant impact on quality of life and the incidence of secondary haemosiderosis, which contributes to the emergence of co-morbidities, especially cardiovascular. treatment with rhuepo allows for overall erythroid response in 40-60% of patients treated. in this trial, the investigators intend to study the interest of a treatment with epoetin beta in patients with anemia \<10 g / dl in the context of a myelodysplastic syndrome with ipss score \<1. in addition to studying the erythroid response, the investigators will measure the impact on quality of life and functional performance. patients will receive epoetin beta (60 000ui/week). response will be assessed after 12 and 24 weeks of treatment.

objective of the trial assess the level of haematological response according to iwg 2000 and iwg 2006 criteria with a pattern of administration of high doses epoetin beta (neorecormon ®) for 12 and 24 weeks of treatment; to evaluate the predictive value of the rate of reticulocytes at day 8 on the erythroid response; * assess time to response * assess tolerance * assess the impact on quality of life using the fact-an and eq-5d measurement scales; * assess functional capacity: cardiovascular performance on effort by the 6-minute walk test performing the " short physical performance battery " tests evaluation the evaluation of response according to the iwg 2000 and iwg 2006 criteria will be held at 12 and 24 weeks of treatment

Eligibility criteria:
inclusion criteria: * written informed consent * must be 18 years of age or older at the time of screening * myelodysplastic syndrome of the following subtypes : ra, ras, rcmd, rcmd-rs, raeb 1, with ipss score low or intermediate 1 (ipss score \< 1 ) and with anemia defined by hb \< 10 g/dl (with rbc transfusion requirement or not) * for women of childbearing potential, need for effective contraception throughout the study period. exclusion criteria: * intensive chemotherapy within 3 months before inclusion * myelodysplastic syndrome with ipss score \>1 * treatment with rhu-epo or rhu-gcsf within 2 months before inclusion * egog \> 3 ; * other causes of anemia (eg. , iron deficiency, vitamin b12 or folic acid, hypothyroidism before correction) * uncontrolled arterial hypertension * life expectancy less than 6 months * cmml * pregnant or breast feeding female subjects * patients with creatinine clearance less than 30ml/min.
educating and supporting primary care providers in the implementation of evidence-based practices for adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: although numerous studies have demonstrated that a high percentage of primary care providers (pcps) are knowledgeable about the american academy of pediatrics' guidelines for managing adhd, many fail to implement these guidelines correctly. the goal of this project is to increase the use of evidence-based practices (ebp) for assessing and treating children with adhd between 5 and 12 years in the context of primary care practice. this randomized controlled trial will evaluate the whether a 3-part intervention (education about adhd management and communication training, collaborative consultation, and performance feedback regarding use of ebps) is effective in improving ebp use among primary care providers.


Eligibility criteria:
primary subjects: clinicians inclusion criteria: * non-resident clinician (physician or nurse practitioner) at participating site exclusion criteria: * residents secondary subjects: families inclusion criteria: * children aged 5-12 years receiving care from a clinician enrolled in the study for adhd and their parents exclusion criteria: * autism spectrum disorder

Keywords: evidence-based practice provider education
digital planning and guided dual technique in aesthetic crown lengthening

Conditions: Tooth Eruption Disorder

Summary: excessive gingival exposure, commonly named gingival smile, results in a dentogingival disharmony. one of the gingival smile treatment is the aesthetics-related crown lengthening surgery (acl) to provide a adequate clinical crown length and diminish gingival display. in this context, digital planning and guided dual technique have been proposed to increase the effectiveness and predictability of the acl. in this technique, an facial and dental analysis of the patient is performed and transferred to a digital model obtained by intraoral digital scan. the digital model is used to create a double guide that will determine the final position of the gingival and alveolar margin in the acl. despite the technique showing promising results, clinical studies evaluating the effectiveness of this technique are scarce. the present study aims to evaluate the digital planning and guided dual technique in the acl in comparison to conventional technique in relation to the predictability/stability of the gingival margin positioning and patient satisfaction after the acl. twenty-four patients diagnosed with altered passive eruption type i subcategory b will be selected and divided into two groups. in the control group (n = 12) patients will be submitted to the conventional acl planned using clinical examination; in the test group (n = 12) patients will be submitted to acl using cone beam computed tomography (cbct), digital planning and guided dual technique. periodontal clinical parameters including probing depth (ps), clinical attachment level (cal), clinical crown length (ccl), anatomical crown length (acl) and cemento-enamel junction to alveolar bone crest distance will be evaluated clinically at baseline, in the immediate postoperative, 4, 8 and 12 months after the procedure. participants will be submitted to questionnaires to assess satisfaction with the smile, gum and tooth characteristics and experience with the procedure. the investigators aim to demonstrate with the study the effectiveness of the both techniques and evaluate the clinical cost benefit for the patient and the dentist of the guided dual technique in relation to the conventional acl technique.


Eligibility criteria:
inclusion criteria: * non smokers; * periodontal and systemically healthy; * patients with more than 20 teeth including the six maxillary anterior teeth; * altered passive eruption diagnosis (classified as type i subcategory b) in the quadratic anterior teeth. exclusion criteria: * orthodontic treatment; * presence of prosthetic crowns; * extensive restorations; * extensive incisal edge attrition; * misalignment on maxillary anterior teeth.

Keywords: crown lengthening altered passive eruption gingival smile
comparison of two types of bandages in the treatment of lymphoedema

Conditions: Lymphoedema

Summary: the study is a cohort study of patients at the university hospital during the first two days of intensive treatment. the patients are randomly divided into two groups (n=10). throughout the study, group a is treated with the multilayer elastic bandage while group b is bandaged with contention only. the bandages were applied on the first and second day and were maintained in place. the bandages were applied on the first and second day and were maintained for 24 hours. all patients performed 30 minutes of physical activity in the bandage on both days. the evaluation is based on the volumetric difference, skin quality and quality of life of these patients


Eligibility criteria:
inclusion criteria: * adult with unilateral lower limb lymphoedema * stage 2 or 3 lymphoedema * 1st intensive decongestant treatment * ability to sit on a cycloergometer exclusion criteria: * severe cardiac disease * infectious dermoepidermitis * bandage unbearable for the patient

Keywords: lymphology chronic disease reduction bandages
noninvasive assessment of neuromuscular disease using electrical impedance myography

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: the purpose of this protocol is to test a new electrical impedance myography (eim) device and study its reliability and ability to differentiate als patients from healthy controls.

investigators will study 10 als patients and at least 10 age-matched healthy controls between the ages of 21 and 85 years old. for all subjects, eim measurements will be performed on four muscles: two in the upper and two in the lower extremities, using 8 different eim sensors. measurements will be repeated one time.

Eligibility criteria:
inclusion criteria: * diagnosis of probable or definite als by the el escorial criteria exclusion criteria: * history of superimposed generalized neuromuscular disease * primary lateral sclerosis or other atypical motor neuron disorders * forced vital capacity of less than 50% * presence of disease for greater than 5 years since symptom onset

Keywords: als eim
the use of electrical stimulation for determination of epidural catheter placement

Conditions: Obstetric Pain; Anesthesia, Local

Summary: the aim of this study is to address the problem of epidural failure. the investigators theorize epidural failure can be due to inappropriate catheter movement and this may be related to the length of which the epidural catheter is inserted. the investigators will use electrical stimulation to determine if the catheter moved in the sacral direction with insertion.

the research participants will be pregnant women in labor and delivery ward of stanford university hospital who request an epidural for labor analgesia. in this study the patients will receive an epidural catheter in the same way as standard of care. the catheter will be inserted to 20cm and then electrically stimulated to document where it is placed by looking at the muscles effected. the catheter is then pulled back in 5cm increments and stimulated until the standard distance is achieved. for example, if loss of resistance happened at 5cm, the catheter would be inserted to 20cm, stimulated, pulled back to 15cm and stimulated, and finally to 10cm and stimulated. electrical stimulation of epidural catheters for confirmation of placement is a published and accepted technique. in this study, the investigators will perform electrical stimulation at incremental points during catheter pull back with documentation of where stimulation was seen.

Eligibility criteria:
inclusion criteria: * pregnant female requesting epidural for labor analgesia. * must meet standard inclusion criteria for safe epidural placement. * platelet count over 70,000, inr under 1.3. exclusion criteria: * unable to safely place epidural catheter due to commonly accepted patient factors.

Keywords: electrical epidural stimulation test epidural failure
trendelenberg versus left lateral position for colonoscopy

Conditions: Colonic Diseases

Summary: the purpose of this study is to determine if the trendelenberg (td) position (position in procedures that involves placing the patient at an angle so that their head is lower than their feet on the procedure bed) in select patients undergoing colonoscopy is superior than the left lateral (ll) position (patient laying on their side, traditionally used for colonoscopies) in terms of decreasing time necessary to pass the colonoscope through the left colon, and decreasing the difficulty of the procedure.

the colonoscopists will be asked to rate their prediction of difficulty of the procedure prior to the colonoscopy and to rate the ease of procedure after the colonoscopy. the clinical experience of the study investigators is that td positioning is superior to ll positioning in patients with risk factors for having a difficult colonoscopy (thin women; those with diverticulosis- small bulging pouches present in the colon; or prior pelvic surgery). patients with risk factors for difficult colonoscopy will be randomized to undergo colonoscopy while positioned in the td position or the ll position during advancement of the colonoscope through the sigmoid colon. the sigmoid colon is a section of the colon, proximal to the rectum, that is curved. the sigmoid colon is a normal component of gi tract anatomy, although due to it's shape, especially with the risk factors listed previously; can cause challenges to inserting the colonoscope.

Eligibility criteria:
inclusion criteria: 1. personal history of pelvic surgery 2. diverticulosis, identified by patient report or review of previous colonoscopy or imaging studies. 3. bmi \< 25. exclusion criteria: 1. patients who do not meet inclusion criteria. 2. patients who have undergone colonic resection 3. patients with glaucoma 4. patients with uncontrolled acid reflux disease or active nausea/vomiting. 5. patients who are unwilling or unable to consent. 6. bmi \> 30
therapy of ventilator-associated tracheobronchitis caused by gram negative bacteria with nebulized colistin

Conditions: Bronchitis

Summary: the purpose of this study is to determine whether inhaled colistin is effective in the treatment of ventilator associated tracheobronchitis due to gram negative organism susceptible to colistin.

patients diagnosed ventilator-associated tracheobronchitis due to gram negative organism are included to the study.the patients will be received colistin inhalation 75 mg every 12 hours at least 5 days. the primary objective is to evaluate clinical outcome of inhaled colistin. the secondary objectives are microbiological clearance and toxicity of inhaled colistin. the sample size was estimated to 62 patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ventilator-associated tracheobronchitis caused by gram negative organism. * expected to survive more than 48 hours after enrollment. * received intravenous colistin not more than 48 hours prior enrollment. exclusion criteria: * pregnancy and lactation * allergy to colistin * serum creatinine \> 4 mg/dl or gfr decreased more than 75% from baseline
visual and refractive outcomes of the clarvista harmoni™ modular intraocular lens system (hmiol)

Conditions: Cataract; Aphakia

Summary: the purpose of this study was to evaluate visual and refractive outcomes with the use of the harmoni™ modular intraocular lens (hmiol) system implantation, assembly, and optic exchange in subjects undergoing cataract surgery.

all subjects were implanted with the harmoni™ modular intraocular lens (hmiol) system in the right eye, left eye, or both eyes based on the best interest of the subject and the clinical judgment the investigator (day 0, primary implantation) (cohort 1). at month 1 post primary implantation, subjects were given the option to undergo an optic exchange procedure. subjects who underwent the optic exchange (cohort 2) (day 0, optic exchange) were followed for an additional month. subjects who did not undergo an optic exchange were exited from the study, except at 1 site, which followed subjects up to month 12. alcon research, llc, acquired clarvista medical in 2017. this study was designed and conducted by clarvista medical, inc. the study results were collected, analyzed, and provided by clarvista medical, inc. to alcon research, llc.

Eligibility criteria:
key inclusion criteria: * able to understand and sign an approved informed consent form (icf); * willing and able to return for scheduled treatment and follow-up examinations; * planned removal of cataracts (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction; key exclusion criteria: * any ocular conditions which could affect the stability of the iol in either eye; * traumatic or congenital cataract; * pregnancy or planned pregnancy during the study period; * medications that may confound the outcome or increase risk to the subject; * any clinical finding or intraocular complication during primary cataract surgery or implantation of the lens system likely to increase complications or risk to the subject; * other protocol-specified exclusion criteria may apply.

Keywords: intraocular lens iol intraoperative exchange
iop patterns in ocular hypertensive patients newly converted to glaucoma vs stable ocular hypertensive patients

Conditions: Ocular Hypertension

Summary: the purpose of the study is to assess the relationship between iop pattern as recorded over 24 hours by using triggerfish and quantified by acrophase scored dichotomously, and conversion to glaucoma in oht patients (conversion status). elevation of iop above normal range is called "ocular hypertension" (oht). in a previous study, it has been shown that oht patients who progress to glaucoma (converters) have at baseline and prior to any conversion, iop patterns that more closely resemble those of established early primary open-angle glaucoma (poag) patients, while stable oht patients (non-converters) have iop patterns closer to those of healthy control subjects. the study has been planned to recruit at least 48 eligible patients (24 converters and 24 non-converters).


Eligibility criteria:
inclusion criteria: * diagnosis of oht (iop \>21 mmhg on 2 consecutive visits) in the study eye * no iop-lowering drug treatment in the study eye; otherwise, a 4-week wash-out period prior to study day 0 (sd0) and throughout the study * aged ≥ 18 years, of either sex * not more than 6 diopters spherical equivalent in the study eye * having given written informed consent, prior to any investigational procedures exclusion criteria: * narrow iridocorneal angle or any other concomitant ocular conditions (except cataract) in the study eye * history of ocular surgery on the study eye (except cataract extraction) * history of laser treatment on the study eye * corneal or conjunctival abnormality in the study eye, precluding contact lens adaptation * severe dry eye syndrome * subjects with irregular sleep schedules * subjects who are current smokers * subjects with allergy to corneal anesthetic * subjects with contraindications for silicone contact lens wear * subjects not able to understand the character and individual consequences of the investigation * participation in other clinical research within the last 4 weeks * any other contra-indication listed in the tf user manual