Kornimate/medical-research-clean huggingface dataset:
assessment of catheter-based interrogation and standard techniques for fractional flow reserve measurement

Conditions: Coronary Artery Disease

Summary: this study will assess the differences between fractional flow reserve (ffr) measurements made by the navvus catheter and a commercially available pressure guidewire in up to 240 subjects where ffr is clinically indicated. all subjects will receive diagnostic treatment according to clinical indications and center standard practice.

the acist-ffr study is a prospective, open label, observational, multi-center study designed to assess the differences, if any, between ffr measured by the navvus catheter and a commercially available 0.014-inch pressure guidewire (st. jude medical, volcano, hereafter referred to as the pw) in subjects with coronary artery disease (cad) undergoing coronary angiography. this will be accomplished by comparing the ffr measurement obtained with the acist medical systems rxi system and navvus catheter with the ffr measurement obtained by using a pw within the same subject across the same target lesion at the same time.

Eligibility criteria:
general inclusion criteria: * subject is 18 years of age or older * subject has a clinical indication for coronary angiography * subject or subject's legal representative has the ability to understand and provide signed consent for participating in the study angiographic inclusion criteria: * vessel has a timi flow = 3 * subject has de novo lesion which physician has determined has a clinical indication for ffr measurement * rvd of the target lesion is assessed by the operator to be ≥2.25 mm. general exclusion criteria: * subjects with acute st-elevation or non-st-elevation myocardial infarction as the indication for coronary angiography * nyha class 4 severe heart failure angiographic exclusion criteria: * target vessel has angiographically visible or suspected thrombus. * target lesion is within a bypass graft. * angiographic evidence of a dissection prior to initiation of pw measurements. * target vessel contains excessive tortuosity or calcification.

Keywords: fractional flow reserve rapid exchange catheter
assessment of family planning and immunization service integration in malawi

Conditions: Contraception; Contraceptive Usage; Contraception Behavior; Infant, Newborn, Diseases

Summary: this is a mixed methods process evaluation of a programmatic intervention to integrate family planning and immunization services at health facilities and through outreach services in dowa and ntchisi districts of malawi. the study involved qualitative methods (in depth interviews and focus group discussions with service providers, mothers and fathers of infants \<1 year, and supervisors and program managers) as well as secondary analysis of service statistics for family planning and immunization services and of supervision reports.


Eligibility criteria:
inclusion criteria: * all health facilities and associated outreach sites in ntchisi and dowa districts implementing the integrated approach with support from the usaid-funded maternal and child survival program exclusion criteria: * all health facilities and associated outreach sites not implementing the integrated approach with support from the usaid-funded maternal and child survival program

Keywords: immunization
clinical outcome of hormonal receptor positive, her-2 negative breast cancer in taiwan

Conditions: ER/PR(+), Her2(-) Breast Cancer

Summary: breast cancer is the most common cancer in taiwanese women. most of them were diagnosed in relatively early stages. only 700 metastatic breast cancer were registered in official cancer registration 2012, while more than11,305 were registered as early breast cancer. with broadly application of aromatase inhibitors, hormonal-receptor-positive breast cancer patients can survive longer and longer. however, there is no prevalence of metastatic breast cancer can be available yet. nhia database coverage is more than 90% population in taiwan, thus it can be an appropriate surrogate of prevalence. in this retrospective database analysis, we will explore the real world experience on aromatase inhibitor use for breast cancer in taiwan.


Eligibility criteria:
inclusion criteria: * hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer exclusion criteria: -

Keywords: hormonal receptor positive, human epidermal growth factor receptor 2 negative, breast cancer, aromatse inhibitor, overall survival, prevalence
calcitonin pre-treatment to improve spect-ct sensitivity

Conditions: Primary Hyperparathyroidism; Hypercalcemia

Summary: patients with biochemically confirmed primary hyperparathyroidism and non-localizing spect-ct exam within the past year will be included. subjects will be treated with calcitonin to lower calcium levels immediately prior to reimaging. the goal of this study is to determine whether lowering calcium will improve uptake/retention of sestamibi and improve sensitivity of spect-ct to localize parathyroid adenoma.


Eligibility criteria:
inclusion criteria: * diagnosis of primary hyperparathyroidism * non-localizing spect-ct performed within 365 days prior to consent to participate in study * patient desires surgical intervention for treatment of phpt * no contraindications to 99mtc-sestamibi * no contraindications to treatment with calcitonin * serum calcium level prior to non-localizing spect-ct is ≥10.5 mg/dl * patient consents to participate and undergo second spect-ct for purposes of research exclusion criteria: * previous surgery to the neck, including resection of parathyroid tissue, except where end organ damage is present and further surgical intervention is medically necessary * contraindication to 99mtc-sestamibi spect-ct as evidenced by allergic reaction or adverse event during index spect-ct * allergy to calcitonin * hypocalcemia (contraindication to calcitonin) * vitamin d deficiency (contraindication to calcitonin) * previous treatment with radioactive iodine * new prescription of thyroid medication (levothyroxine, armour thyroid tablets, etc. must be taken at time of index scan and research scan) * lithium exposure within one year of spect-ct (index and research scans) * secondary hyperparathyroidism * benign familial hypocalciuric hypercalcemia * known malignancy, particularly multiple endocrine neoplasia * new prescription of thiazide diuretic, (thiazide diuretic must have been taken at the time of index scan and second scan) * currently taking calcium channel blockers * pregnancy
azd2115 single ascending dose study

Conditions: Chronic Obstructive Pulmonary Disease; Lung Disease Causing Persistent Narrowing of the Airways

Summary: azd2115 single ascending dose study


Eligibility criteria:
inclusion criteria: * healthy male subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture * male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the day of dosing until 3 months after dosing with the investigational product. * have a body mass index (bmi) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg * be able to inhale from a spira nebuliser according to given instructions exclusion criteria: * prolonged qtcf \>450 ms or shortened qtcf \<340 ms or family history of long qt syndrome * any clinically important abnormalities in heart rhythm, conduction or morphology of resting ecg that may interfere with the interpretation of qtc interval changes. this includes subjects with any of the following: * pr (pq) interval prolongation \>200 ms (first degree av block) * intermittent second or third degree av block (based on screening or pre-dose ecg) * incomplete, full or intermittent bundle branch block (qrs \<110 ms with normal qrs and t wave morphology is acceptable if there is no evidence of left ventricular hypertrophy) * abnormal t wave morphology, particularly in the protocol defined primary lead * dropped beats * history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to azd2115 and/or excipients * history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs * serum potassium concentration of \<3.80 mmol/l on admission (day -1)

Keywords: safety tolerability healthy inhaled respiratory disease
a 4-day study to evaluate the photoxicity of diacerein 1% topical ointment in healthy volunteers

Conditions: Healthy

Summary: this study was designed to assess the phototoxic potential of diacerein 1% ointment when application is followed by light exposure.

this was a single-center, randomized, within-subject comparison of diacerein 1% ointment and vehicle ointment applied to 2 sites on opposite sides of the the infrascapular area of the back under occlusive patch conditions for approximately 24 (±2) hours. product was applied according to the randomization scheme in an amount of 0.2 ml, once during the study. patches were removed and 1 of the skin sites for each product was irradiated and 1 remained non-irradiated. the irradiated and non-irradiated sites were compared with each other and with an untreated irradiated control site.

Eligibility criteria:
key inclusion criteria: * is a healthy male or female (to be confirmed by medical history); * is 18 years of age or older; * in the case of a female of childbearing potential, is using two acceptable forms of birth control; * in the case of a female of childbearing potential, has a negative urine pregnancy test (upt) at day 1 and are willing to submit to a upt at the end of study (eos); * is free of any systemic or dermatological disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events (aes); * is of any fitzpatrick skin type or race, providing the skin pigmentation will allow discernment of erythema key exclusion criteria: * has a history of photosensitivity or photoallergy; * has any visible skin disease at the application site which, in the opinion of the investigator, will interfere with the evaluation of the test site reaction; * is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study; * is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin (occasional use of acetaminophen will be permitted); * is taking medication known to cause phototoxic reactions (eg, tetracyclines, thiazides, nonsteroidal anti-inflammatory drugs \[nsaids\]); * has psoriasis and/or active atopic dermatitis/eczema; * has known sensitivity or allergy to constituents of materials being evaluated including diacerein, mineral oil, petrolatum, cetyl alcohol, d\&c yellow #10 and/or ethyl paraben; * has damaged skin in or around the test sites, including sunburn, excessively deep tans,uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site; * has received treatment for any type of internal cancer within 5 years prior to study entry; * has any known sensitivity to adhesives; and/or * has received any investigational drug(s) within 4 weeks prior to study entry
efficacy and tolerability of idebenone in boys with cardiac dysfunction associated with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy (DMD)

Summary: idebenone is a synthetic analogue of coenzyme q10 and is a powerful antioxidant and essential constituent of the process of energy production on the cellular level. it can protect mitochondria from oxidative damage and boost their impaired function. it is thought that this mechanism will slow decline in heart function that is part of the disease process of duchenne muscular dystrophy (dmd). it is possible that patients may benefit in terms of muscle strength and respiratory function. this pilot trial is designed to investigate this.


Eligibility criteria:
inclusion criteria: * patients 8 - 16 years of age at time of enrolment * male * presence of cardiac involvement/dysfunction, defined by abnormal peak systolic strain in left ventricle (lv) inferolateral wall * confirmed diagnosis of dmd (out of frame dystrophin gene deletion or absent/\<5% dystrophin protein on muscle biopsy; clinical picture consistent of typical dmd) * if on chronic glucocorticosteroids treatment (deflazacort, prednisone) for dmd (or any other disease) (i.e. concomitant medication): dosage must be stable (unchanged) 6 months prior to inclusion * if on chronic medication for dmd associated cardiomyopathy (β-blocker, diuretics): dosage must be stable (unchanged) 3 months prior to inclusion * ability to provide reproducible repeat quantitative muscle testing (qmt) upper limb score within 15% of first assessment score (at visit1/day 1 versus screening visit exclusion criteria: * symptomatic cardiomyopathy or heart failure * asymptomatic but severe cardiac dysfunction on baseline (screening) evaluation: fractional shortening (fs) \< 20% and/or ejection fraction (ef) \< 40% * use of ace-inhibitors * previous history of ventricular arrhythmias (other than isolated ventricular extrasystole); ventricular arrhythmias presented at screening * previous (6 months or less) participation in any other therapeutic trial for dmd * use of coenzymeq10, idebenone, creatine, glutamine, oxatomide, or any herbal medicines within the last 6 months * history of significant concomitant illness or significant impairment of renal or hepatic function * known individual hypersensitivity to idebenone

Keywords: duchenne muscular dystrophy dmd duchenne
comparison between oral melatonin and hydroxyzine in pediatric patients undergoing adenotonsillectomy

Conditions: Effect of Drug; Anxiety

Summary: comparison between the effect of oral melatonin and hydroxyzine for preventing preoperative anxiety in pediatric patients undergoing adenotonsillectomy

the aim of the study is to compare the effectiveness of preoperative oral melatonin and hydroxyzine on preoperative anxiety in pediatric patients undergoing adenotonsillectomy. the primary outcomes: 1. ease of parenteral separation. 2. the compliance to anesthesia induction in pediatric patients. the secondary outcomes: 1. assessment of postoperative pain. 2. time to first analgesic request.

Eligibility criteria:
inclusion criteria: 1. asa: class l 2. sex: male and female 3. age: from 3 to 10 years old 4. children scheduled for adenotonsillectomy exclusion criteria: 1. all children with a history of chronic illness, or developmental delay were excluded from the study 2. history of an autoimmune disease 3. concurrent use of immunosuppressive treatment 4. sleep disturbances, speech or communication problems 5. allergic to hydroxyzine, cetirizine, or other derivatives of piperazine, aminophylline, and ethylenediamine. 6. hydroxyzine is contraindicated in patients with acute porphyria -

Keywords: melatonin hydroxyzine preoperative anxiety pediatric adenotonsillectomy
cognitive control and metacognition training

Conditions: Autism; Autism Spectrum Disorder

Summary: 95 autistic children (ages 8-11yrs) will be randomly assigned to a novel computer-based cognitive control training combined with metacognition coaching or to a comparison group that receives the intervention after a delay. before and after intervention, electroencephalography (eeg) will be used to examine engagement of the target neural responses.

effective interventions to reduce the functional impact of core features of autism spectrum disorder (asd) in school-aged children are critically needed. this study will test whether in-person computer training delivered individually by a coach engages an electroencephalographic (eeg) biomarker of cognitive control (n2 event-related potential \[erp\] amplitude). developing more effective cognitive control, metacognition, and working memory is predicted to enhance neural responses to conflicting information (i.e., a neural marker of effective cognitive control). the study will randomly assign 95 autistic children (ages 8-11yrs) to a novel computer-based cognitive control training combined with metacognition coaching or to a waitlist control group. before and after intervention, eeg will be used to examine engagement of the target neural responses. we expect the group assigned to cognitive control training + metacognition coaching to exhibit significantly larger changes in n2 erp amplitude in incongruent relative to congruent trials than the waitlist group. before and after intervention, we will collect neural responses and behavioral measures of cognitive control and working memory.

Eligibility criteria:
inclusion criteria: * children should be 8 to 11 years of age * children should have an existing diagnosis of an autism spectrum disorder, which will be confirmed using research measures and criteria * children must have general cognitive ability in the average range or above (above 80 using the wechsler abbreviated scale of intelligence-2 full scale iq) * caregivers and children must be fluent in english or spanish exclusion criteria: * children must not have a known genetic condition related to autism (e.g., fragile x) * children must not have medical conditions/injuries, exposure to substances, or significant deprivation with implications for the central nervous system or that require regular psychoactive medications that alter eeg responses (anticonvulsants, barbiturates) \* * children must not have seizures or a seizure disorder (other than history of febrile seizures) * children must not have significant sensory or motor impairment or major physical abnormalities that would limit the ability to participate in table top or eeg testing, or make responding during computer activities difficult * children must not have a failed screening for colorblindness
krt-232 and tki study in chronic myeloid leukemia

Conditions: Chronic Myeloid Leukemia

Summary: this study evaluates krt-232, a novel oral small molecule inhibitor of mdm2, for the treatment of patients with ph+ chronic myeloid leukemia (cml) who have relapsed or are refractory or intolerant to a tyrosine kinase inhibitor (tki). this study is a global, open label phase 1b/2 to determine the efficacy and safety of krt-232 in patients with chronic phase cml (cml-cp) and accelerated phase (cml-ap) who have failed tki treatments.


Eligibility criteria:
inclusion criteria: * phase 1b and phase 2 arms a and b: documented tp53wt, ph+, bcr-abl+ cml-cp * phase 2 arm c only: documented tp53wt, ph+, bcr-abl+ cml-ap * subject is resistant (relapsed or refractory) and/or intolerant to at least 1 prior tki. * adults ≥ 18 years of age. * ecog performance status of 0 to 2 * adequate hematologic, hepatic, and renal functions exclusion criteria: * phase 1b and phase 2 arms a and b: documented ph+, bcr-abl+ cml-ap * documented ph+, bcr-abl+ cml-bc * known t315i mutation. * prior treatment with mdm2 antagonist therapies. * intolerance to current tki therapy.

Keywords: navtemadlin
effectiveness of technology-enabled exercise program in firefighters with shoulder pain.

Conditions: Shoulder Pain

Summary: to assess if a technology-enabled exercise program plus education (teep + e) is more effective than education program (ep) alone, in providing better outcomes (quality of life, at-work disability and productivity loss, firefighters' perception, adherence, overall improvement/deterioration) in firefighters with shoulder pain, at 3-, 6-and 12-month follow ups.


Eligibility criteria:
inclusion criteria: * active duty firefighters aged 18 to 100 years, with shoulder pain. * do not permanently use strong pain medications. * able to understand spoken and written english. * access to computer, internet and telecommunications application software (skype). exclusion criteria: * firefighters who have had shoulder related surgeries in the last 6 months.
molecular endotype-specific dynamics of lung endothelial barrier integrity in sepsis

Conditions: Sepsis; Septic Shock; Pneumonia

Summary: sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. no drug specifically targeting sepsis has been approved. the heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. recent clinical genomics studies have shown that sepsis patients can be stratified as molecular endotypes, or subclasses, with important clinical implications. classifying sepsis patients as molecular endotypes revealed that a poor prognosis endotype was characterized by immunosuppression and septic shock. against this backdrop, the study hypothesis is that a poor prognosis for sepsis is defined by a molecular endotype reflecting impaired innate immune and endothelial barrier integrity in the primary anatomical site of infection.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * acute respiratory tract infection due to community- or hospital-acquired pneumonia exclusion criteria: * consent card not signed * pregnancy * prisoners * aspiration pneumonitis * patients with ventilator-associated pneumonia
effect of the food supplement totum-070 on lipid metabolism

Conditions: Hypercholesterolemia

Summary: this clinical trial is to confirm the effects of totum-070, a mix of 5 plants extracts, consumed at the daily regimen of two times per day, on fasting blood ldl cholesterol concentrations in moderately hypercholesterolemic subjects after 12 weeks of consumption (v3).

the main objective is to confirm the efficacy of a 4.995g/day dose of totum-070 versus placebo on fasting blood ldl cholesterol level (ultracentrifugation (uc) method) in moderately hypercholesterolemic subjects following 12 weeks of consumption (v3). the proposed double-blinded, placebo-controlled, clinical study will provide further insight into the safety and efficacy of totum-070 at the same dose (4.995g/day) on a shorter supplementation period (3 months) than the previous one (6 months), as well as assess the effect after the follow-up period without product intake.

Eligibility criteria:
main inclusion criteria: * i1. from 18 to 70 years (including ranges); * i2. bmi of ≥18.5 and ≤35 kg/m²; * i3. moderately hypercholesterolemic subject without any clinical symptoms of hypercholesterolemia (xanthoma, recurrent chest and/or leg pain...) and not requiring immediate pharmacological lipid-lowering treatment; * i4. weight stable within ± 5% in the last three months before v0; * i5. score2 - score2-op (older persons) cardiovascular risk chart main exclusion criteria: * e1. suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal dysfunction or other metabolic disorder needing a dose adjustment in drug intervention according to the professional recommendations; * e2. suffering from an uncontrolled arterial hypertension; * e3. with a history of ischemic cardiovascular event; * e4. having undergone recent surgical procedure in the past 6 months before v0 or planned in the 5 months to come; * e5. history of bariatric surgery; * e6. suffering from a severe chronic disease; * e7. for women: ongoing pregnancy (as evidenced by a positive test for β-human chorionic gonadotropin, i.e. \> 5 mui/ml, realized at v0) or breastfeeding or finished since less than 6 months before v0 or intending to become pregnant within 5 months ahead; * e8. under cholesterol and/or lipid-lowering treatment or stopped less than 3 months before the inclusion visit v0; * e9. under medication which could affect blood lipid parameters or stopped less than 3 months before the inclusion visit v0 (antihypertensive stable long-term treatment tolerated); * e10. consuming more than 3 standard drinks daily of alcoholic beverage for men or 2 standard drinks daily for women