Kornimate/medical-research-clean huggingface dataset:
parent education and medical play: a comparison of psychological preparation strategies for voiding cystourethrogram

Conditions: Vesicoureteral Reflux

Summary: hypothesis: the use of parent education and medical play will be able to reduce patient discomfort with potential uncomfortable medical procedures. children that have urinary tract infections and those diagnosed with vesicoureteral reflux undergo a procedure called a voiding cystourethrogram (vcug) to identify and follow vesicoureteral reflux. for many children and parents this can lead to considerable distress. pre-procedure preparation can potentially reduce anxiety and improve overall experience with the procedure.

children that are evaluated medically and found to need a vcug would be eligible for participation in this study. children would be randomized to having play therapy or a parental education brochure. the study would have no impact on the child recieving the state of the art medical care. play therapy involves having the child play through the process of the study with a child life therapist, in an effort to prepare the child for the procedure. parents/patients will be given a pre and post procedure evaluation form to objectively categorize the parental/patient perception of the experience with the study.

Eligibility criteria:
inclusion criteria: * children that have been identified to need a voiding cystourethrogram exclusion criteria: * significant medical conditions that preclude child from being able to understand play therapy or have been identified in the past to have so much discomfort from prior studies as to not be able to participate.

Keywords: play therapy urinary tract infections children vesicoureteral reflux
ritonavir and agenerase treatment for patients who have failed previous anti-hiv treatment

Conditions: HIV Infections

Summary: the purpose of this study is to determine if treatment with an anti-hiv drug containing ritonavir and agenerase is safe and can lower the level of hiv in the blood in patients who have failed an anti-hiv drug treatment containing nelfinavir.

hiv-infected patients will be treated with a ritonavir-enhanced agenerase regimen.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are 18 years of age or older. * are hiv-positive. * have a viral load (level of hiv in the body) of more than 1,000 copies/ml. * have had more than 12 weeks of prior anti-hiv drug treatment. * have failed a previous anti-hiv treatment containing nelfinavir as the only protease inhibitor. * are responsive to agenerase. * are able to follow study requirements. exclusion criteria patients will not be eligible for this study if they: * are intolerant to ritonavir (an anti-hiv drug). * have or have had problems with absorption. * have liver disease or damage. * have pancreatic disease or damage. * have taken any protease inhibitor other than nelfinavir. * are receiving investigational drugs or devices from another study. * are pregnant or breast-feeding. * currently use triazolam, astemizole, ergot medications, cisapride, midazolam, bepridil, rifampin, terfenadine, or pimozide. * have a bleeding disorder. * have previously been treated with agenerase. * are receiving nonnucleosides.

Keywords: drug therapy, combination hiv protease inhibitors ritonavir vx 478 salvage therapy anti-hiv agents drug monitoring nelfinavir treatment experienced
transcranial magnetic stimulation (tms) in genetic epilepsies

Conditions: Epilepsy; Genetic Disease

Summary: transcranial magnetic stimulation (tms) uses electromagnetic induction as an efficient, painless, non-invasive method to generate a suprathreshold current at the level of the encephalon, and provide in vivo measurements of cortical excitability and reactivity at the level of the motor cortex (tms-emg) or the entire cortical mantle (tms-eeg). this study proposes tms measurements as a diagnostic tool in patients to understand mechanisms of epileptogenesis related to genetic mutations, and prognostic to guide and monitor precision treatments.


Eligibility criteria:
inclusion criteria: * children aged \>3 years and adults * diagnosis of epilepsy with presumed or confirmed genetic etiology. diagnosis of genetic epilepsy is made by next-generation sequencing (ngs) analysis * or diagnosis of primary (non-hemicranial) headache, in the absence of alterations on neuroimaging, and no known genetic condition * obtaining informed consent exclusion criteria: * age \<3 years * presence of contraindications to tms: history of head or eye trauma with inclusion of metal fragments, cardiac pacemaker, arrhythmic heart disease, hearing implants, implantation of drug delivery devices, piercings or tattoos with metallic ink. * pregnancy status
effects of a 10 component dietary supplement on health and the quality of life

Conditions: Blood Pressure; HDL Low; Stress; Lung Function Decreased; Quality of Life; Energy Supply; Deficiency; Concentration Ability Impaired; Joint Instability; Immune Deficiency

Summary: this open-label field trial evaluates the effects of treatment with a multi-pathway dietary supplement (stem cell 100+) that has been commercially available for several years. the objective of the intervention trial is to determine if normal subjects over 35 years of age experience any observable health benefits from the dietary supplement as to their blood pressure, pulse rate, blood cholesterol, lung capacity, stress levels, or self reported changes in markers of overall health and life expectancy.

currently, only dietary restriction has been verified to slow the rate of aging and to promote general health. this trial is designed to see whether a complex supplement (stem cell 100+) that targets multiple longevity pathways could also have positive effects on several markers of successful aging and good health. multipath causes of aging include: stem cell function, telomere loss, chronic stress, inflammation, insulin-like growth factors, autophagy, vascular loss, neural dysfunction, and oxidative stress. the goal of the study was to test the effects of this novel multipath intervention strategy in a clinical trial of healthy people using health markers such as blood pressure, cholesterol status, lung function, stress levels, and self-reported health status. hundreds of published animal and human clinical studies have been done with each of the individual active ingredients in the formulation, which target many critical causes of aging. based on their published animal studies showing extension of life span in a model animal and their laboratory work on adult human stem cells, the investigators believe that stem cell 100+ will provide evidence of efficacy in addressing multiple index markers of health and life expectancy outcomes.

Eligibility criteria:
inclusion criteria: * no history of serious cardiovascular, cancer, or neural disease. * normal health for age * willing to have blood drawn at baseline and after trial * willing to submit to evaluation testing of blood pressure, lung testing, stress testing. * willing to take online self reported survey of health at end of trial exclusion criteria: * history of metastatic cancer, heart attack, dementia, or other life-threatening disease * any subject who is not capable of responding to a self-reported online questionnaire * pregnant
jsp191 antibody conditioning regimen in mds/aml subjects undergoing allogenic hematopoietic stem cell transplantation

Conditions: MYELODYSPLASTIC SYNDROME; MDS; ACUTE MYELOID LEUKEMIA; AML

Summary: this is a phase 1a/b study to evaluate the safety and tolerability of an antibody conditioning regimen known as jsp191, in combination with low dose radiation and fludarabine, in subjects with myelodysplastic syndrome (mds) or acute myeloid leukemia (aml) undergoing allogenic blood stem cell transplantation.

this is a phase 1a/b study to evaluate the safety and tolerability of an antibody conditioning regimen known as jsp191, in combination with low dose radiation and fludarabine in subjects with myelodysplastic syndrome (mds) or acute myeloid leukemia (aml) undergoing allogenic blood stem cell transplantation. blood stem cell transplantation offers the only potentially curative therapy for many forms of acute myeloid leukemia (aml) and for myelodysplastic syndrome (mds). while standard of care conditioning regimens given prior to blood stem cell transplantation, such as standard tbi/flu conditioning are well tolerated, they are associated with increased rates of relapse due to persistence of disease causing hematopoietic stem cells and insufficient graft versus leukemia effect. the biological conditioning regimen jsp191 is an antibody that binds to cd117. cd117 is the receptor for stem cell factor on blood forming cells. cd117 binding to stem cell factor is critical for survival and maintenance of blood forming stem cells. the binding of jsp191 to cd117 blocks cd117 from binding to stem cell factor on blood forming stem cells. in the absence of cd117/stem cell factor binding, hematopoietic stem cells that are currently occupying the bone marrow niches in mds/aml patients are depleted. this study will investigate the safety and tolerability of adding jsp191 (an anti-cd117 monoclonal antibody therapy) to standard tbi/flu conditioning regimen in adults with aml and mds undergoing hematopoietic stem cell transplant.

Eligibility criteria:
key inclusion criteria: * aml/mds as defined by specific criteria, including but not limited to the following subtypes: 1. aml in cr 2. mds \< 5% bm blasts 3. mds 5 - 10% bm blasts 4. aml not in cr or mds \> 10% bm blasts * patients with human leukocyte antigen (hla) matched related or unrelated donors * adequate end organ function as defined in study protocol key exclusion criteria: * patients with any acute or uncontrolled infections * patients receiving any other investigational agents * patients with active non-hematologic malignancy * prior allogeneic hematologic cell transplantation

Keywords: acute myeloid leukemia aml mds myelodysplastic syndrome
does zumba improve cognition in healthy apoe e4 carriers and noncarriers

Conditions: Cognitive Impairment

Summary: the main purpose of this study is to compare the effects on attention and memory functioning to participating in an aerobic and dance exercise called zumba to educational program on exercise that encourages regular stretching and walking.


Eligibility criteria:
inclusion criteria: * healthy women between the ages of 55-80 without cognitive complaints exclusion criteria: * history of significant health conditions

Keywords: zumba exercise apoe
a registry-based cluster randomized trial to compare the effect of spironolactone vs. eplerenone on clinical outcomes in patients with symptomatic systolic heart failure

Conditions: Systolic Heart Failure

Summary: objective the objective is to compare the efficacy of spironolactone and eplerenone on clinical outcome in patients with heart failure and a reduced ejection fraction. method the study is a crossover cluster randomized trial. each heart failure clinic in denmark will be allocated to four periods (clusters): two periods with spironolactone and two periods with eplerenone as first drug. the planned total participation time for each department is 4 years and we estimate that data from 7200 patients will be accrued in this period. endpoints will be assessed through danish national registries.


Eligibility criteria:
inclusion criteria: * all patients registered in the danish heart failure registry who has a baseline left ventricular ejection fraction \<40% and who has filled in a prescription for an aldosterone antagonist exclusion criteria: * patients who had filled in a prescription for an aldosterone antagonist prior ro registration in the danish heart failure registry

Keywords: aldosterone antagonists spironolactone eplerenone mortality
derivatives of omega-3 hufa as biomarkers of traumatic brain injury

Conditions: TBI

Summary: this is a phase 2 clinical trial designed to obtain data on relationships between potentially therapeutic doses of n-3 hufa (highly unsaturated fatty acids) and their bioactive molecular derivatives, synaptamide, 17-hydroxy-dha, and d-series resolvins, on clinical outcomes after tbi.


Eligibility criteria:
inclusion criteria: 1. age 18-55 2. documented/ verified tbi 3. ability to swallow study agent within 48h of injury 4. if a sexually active female who is able to get pregnant, must be already taking birth control (prescription contraception) 5. visual acuity/ hearing adequate for testing 6. fluency in english or spanish 7. ability to provide informed consent for themselves 8. co-enrolled in parc-tbi protocol (irb protocol #825783) or track-tbi (irb protocol #825503) 9. gcs 13-15 exclusion criteria: 1. unstable respiratory or hemodynamic status 2. evidence of penetrating brain injury 3. requirement for craniotomy or craniectomy 4. evidence of serious infectious complications 5. acute ischemic heart disease or abnormal heart rhythm 6. history of abnormality in liver function 7. history or evidence of active malignancy 8. history of diabetes 9. history of pre-existing neurologic disorder, such as dementia, uncontrolled epilepsy, multiple sclerosis, strokes, brain tumors, prior severe tbi, or other disorder that confounds interpretation neuropsychological results 10. history of pre-existing disabling axis i psychiatric disorder, such as major depression, schizophrenia, bipolar disorder or dementia 11. allergy to omega-3 fatty acid ethyl esters or any ingredient of the study agent. 12. known allergy to safflower seed oil or ragweed plants 13. consumption of fish or seafood 3 or more times per week on average or regular administration of omega-3 supplements (e.g., cod liver oil, borage oil, fish oil or evening primrose oil) defined as an average of 250 mg/day of n-3 hufas, over the previous 3 months. 14. pregnancy or breast-feeding 15. prisoners or patients in custody 16. allergy, hypersensitivity, or intolerance to fish oils or omega-3 fats which are found in fish. 17. use of anticoagulant medications or aspirin more than once per week within the last three months 18. enrollment in any concurrent research protocols that would interfere with participant safety or research data integrity.

Keywords: tbi dha omega-3 highly unsaturated fatty acids synaptamide
the effect of xolair (omalizumab) on allergy blood cells

Conditions: Asthma

Summary: we are studying xolair (omalizumab) to see it's effect on allergic blood cells. the blood tests will be done in a test tube to see if they react differently before and after treatment. the blood cells will be mixed with to whatever the person is allergic.

must be allergic-asthma with ige between 30 and 700 iu/ml.

Eligibility criteria:
inclusion criteria: * 2 year history of ragweed allergic rhinitis * positive skin prick tests to ragweed \>5 mm wheal diameter * serum ige \<700 iu/m exclusion criteria: * use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 1 week * history of immunotherapy in the past 2 years * exposure to omalizumab in the past 2 years * clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens * asthma other than mild intermittent * women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding * known sensitivity to study drug xolair * patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study * patients with a previous history of cancer * use of any other investigational agent in the last 30 days

Keywords: allergic asthma anti ige xolair basophil il-13 il-4 histamine
nebulized furosemide in premature infants with bronchopulmonary dysplasia - a cross over pilot study of its efficacy and safety

Conditions: Premature Birth; Premature Infant

Summary: this is a prospective,randomized, cross over study comparing the efficacy and safety of nebulizedfurosemide with intra venous (iv)furosemide in preterm infants who areventilator-and oxygen dependent. reviewing the patient census on neo data by the sub investigator will identify the potential subjects. subject will be randomized to either a arm or b arm. subjects in the a arm will receive 1 mg/kg of inhaled furosemideq 24 hours for 3 days. this will be followed by a washout period of a day followed by 1mg/kg of intravenous furosemide q 24 hours for 3 days. subjects in the b arm will receive 1 mg/kg of intravenous furosemide q 24 hours for 3 days followed by a washout period, which is then followed by 1 mg/kg of inhaled furosemide q 24 hours for 3 days.


Eligibility criteria:
inclusion criteria: * subjects who are born prematurely at\<34 weeks of gestation * subjects who are at least 14days old, on oxygen and mechanical ventilation. * radiologic evidence of pulmonary parenchymal disease * the nicu medical team to start furosemide administration as a part of the routine clinical management exclusion criteria: * subjects who have received any diuretics;iv or po for 48 hoursbefore the study initiation * subjects with congenital heart disease withr-l shunts. * subjects with acute sepsis. * subjects with kidney diseasedefined by creatinine \> 1mg/dl or oliguria, defined as urine output \< 0.6 ml/kg/hour * subjects with necrotizing enterocolitis (nec)or suspected nec * subjects with congenital malformations.subjects who are receiving steroids, or have received steroids in the last 7 days(patients need to be off steroids for at least 7 days).
a study in europe based on medical records that looks at the safety of dabigatran in children below 2 years of age who have had a blood clot and are at risk of developing another blood clot

Conditions: Venous Thromboembolism

Summary: the study is designed to collect and evaluate dabigatran etexilate (de) safety in the context of routine anticoagulation care provided in the european union (eu)/european economic area (eea) for children under 2 years of age. the non-interventional study will be conducted in paediatric hospitals or paediatric departments of eea member states where venous thromboembolism (vte) patients of the evaluated age group are treated.


Eligibility criteria:
inclusion criteria: * written informed consent from parents/care givers * children from birth to less than 2 years of age * initiation of dabigatran etexilate (de) administration: * for treatment of venous thromboembolism (vte) or/and * prevention of recurrent vte due to presence of unresolved clinical vte risk factor(s). exclusion criteria: * participation in any randomised clinical trial or use of any investigational product * any contraindications to de according to the eu summary of product characteristics (smpc)
the effect of watching short videos on preoperative anxiety

Conditions: Anesthesia; Anxiety

Summary: preoperative anxiety is a common issue observed in pediatric patients prior to endoscopic procedures, and it can negatively affect the patient's overall experience. the aim of this study is to evaluate whether watching short videos on platforms such as youtube shorts, instagram reels, or tiktok has an impact on preoperative anxiety levels in pediatric endoscopy patients.

the study was designed as a prospective randomized trial. patients aged 6-12 years undergoing endoscopy and/or colonoscopy in the pediatric endoscopy unit will be divided into the video and the control groups. patients will be taken to the preoperative preparation unit, where those in the video group will watch short videos of their choice on a phone/tablet for 20 minutes under the supervision of their parents. the control group will receive standard preoperative preparation. anxiety levels will be assessed using the modified yale preoperative anxiety scale (mypas) at six different time points: upon entry to the pre-procedural preparation room (t1), upon exiting the pre-procedural preparation room (t2), in the procedure room (t3), upon entry to the recovery unit (t4), at the 15th minute in the recovery unit (t5), and upon exiting the recovery unit (t6). additionally, the indication for the procedure (e.g., celiac disease, crohn's disease, ulcerative colitis), history of prior endoscopy/colonoscopy, oxygen saturation (spo2%), heart rate (hr), mean arterial pressure (map) during the procedure, and the duration of monitoring in the recovery unit will also be recorded.

Eligibility criteria:
inclusion criteria: * patients aged 5-12 years undergoing endoscopy and/or colonoscopy, classified as asa i-ii exclusion criteria: * patients under 5, over 12, or with asa score \>2 * epilepsy

Keywords: anesthesia anxiety short videos pediatric endoscopy
study to evaluate the effects of underlying renal or hepatic dysfunction on the pharmacokinetics of nevirapine

Conditions: Renal Insufficiency; Hepatic Insufficiency

Summary: study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired patients


Eligibility criteria:
inclusion criteria: * male or female patients of any race between the ages of 18 and 75 years with weight within 30% of normal for gender, height and frame as specified by the metropolitan life insurance table * for patients in the renal group: stable creatinine clearance based on two estimations taken at least 3 days apart, corresponding to one of four groups: * group 1 (mild dysfunction) = 50 ml/min \<= creatinine clearance (clcr) \< 80 ml/min * group 2 (moderate dysfunction) = 30 ml/min \<= clcr \< 50 ml/min * group 3 (severe dysfunction) = clcr \< 30 ml/min and * group 4 = end-stage renal disease (esrd) requiring dialysis * for patients in the hepatic group * two baseline creatinine clearances (taken at least 3 days apart) \> 80 ml/min * clinically diagnosed with hepatic insufficiency and class a or b liver disease according to child-pugh's classification; subjects must have a child-pugh score of 5-9 points * for patients in the normal group, i.e. normal with respect to hepatic and renal function * matched with hepatic group regarding gender, age (+- 10 years), weight (+- 30 pounds) and smoking history * two baseline creatinine clearances (taken at least 3 days apart) \> 80 ml/min * no abnormalities on clinical or laboratory evaluations * female patients of childbearing potential must be willing to use a reliable form of contraception which must include a medically approved form of barrier contraception * patients who are able to provide written consent and comply with study requirements exclusion criteria: * female patients who are pregnant or breast-feeding * seated systolic blood pressure either \ 150 mmhg and/or heart rate either \ 90 beats/min * history of any illness or drug allergy that in the opinion of the investigator might confound the results of the study or pose additional risk in administering nevirapine to the subject * patients who have had an acute illness or hospitalization other than for routine dialysis within 2 weeks prior to study initiation * patients who are currently taking any over-the-counter drug within 3 days prior to study initiation, or who are currently taking any prescription drug that in the opinion of the investigator in consultation with boehringer ingelheim pharmaceuticals incorporated (bipi) medical monitor and pharmacokineticist might interfere with the absorption, distribution or metabolism on the test drug * significant electrocardiogram (ecg) abnormalities