Kornimate/medical-research-clean huggingface dataset:
comparison of physical versus visual distraction in the reduction of pain during local anesthesia

Conditions: Pain

Summary: the purpose of this study is to compare physical versus visual distractions to determine which technique reduces perceived pain better during local anesthesia injections.

before the local anesthesia injection, patients will be asked to give a preliminary vas score based on what level of pain 0-10 they anticipate they will feel during the local anesthesia injection. following the injection the participant will be asked to quantify the pain felt during the injection on a 0-10 visual analog scale (vas). the vas scores will only be taken from the first injection of the appointment. participants will be asked their gender, race, age, geographic location they spent most of their lives as well. participants will be de-identified and randomly assigned a number that will be recorded along with their collected data on a two-factor, password protected web server. information collected during this study may be used for further analysis and publication.

Eligibility criteria:
inclusion criteria: * patients needing a dental procedure that requires a buccal infiltration with septocaine 1:100,000 epinephrine (epi) (articaine hydrochloride 4% and epi 1:100,000) or an inferior alveolar nerve block injection with 2% lidocaine with 1:100,000 epinephrine. * adults greater than 18 years old. * patients with limited english proficiency will be included only if their primary language is spanish. exclusion criteria: * patients with a known or suspected allergy to anesthetic agent, sulfites, amide-type local anesthetic, or to any ingredient in anesthetic solutions will not be included. * any patients taking medications affecting pain response on the day of the dental appointment. * children younger than 18 years old. * patients with limited english proficiency with a primary language other than spanish

Keywords: dental pain
compare the same dosage of insulin using a combination of cartridges, 30 units as 2 cartridges vs. 1 cartridge

Conditions: Healthy Volunteers

Summary: a phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (hnvs) to evaluate the bioequivalence of ti inhalation powder delivered using the gen2 inhaler and administered as one 30 u cartridge versus a combination of one 10 u cartridge and one 20 u cartridge.


Eligibility criteria:
inclusion criteria: * men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis * no smoking in the past 6 months (including cigarettes, cigars, and pipes) * urine cotinine testing \< 100 ng/ml * body mass index \< 32 kg/m2 * completion of informed consent form exclusion criteria: * fbg \> 100 mg/dl * clinically significant active or chronic illness * history of asthma, chronic obstructive pulmonary disease (copd), or any other clinically relevant chronic lung disease * respiratory tract infection within 4 weeks before screening and between the screening visit and dosing visit * subjects who are experiencing persistent or recurring cough, wheezing, bronchospasm, or dyspnea
non-acute coronary occlusion treated by everolimus eluting stent

Conditions: Coronary Artery Disease; Coronary Occlusion; Percutaneous Coronary Intervention

Summary: chronic total coronary occlusions (cto) have an especially high risk of angiographic restenosis, and need for new revascularization procedures. drug-eluting coronary stents (des) have demonstrated to significantly reduce the risk of restenosis and new revascularization procedures in comparison with bare-metal stents. most data on the efficacy of des come from the sirolimus-eluting coronary stent cypher (cordis corp.), and paclitaxel-eluting coronary stent taxus (boston sci.), and the cypher stent is the only des that has been randomly tested in cto. among second-generation des, everolimus-eluting stent (ees) has shown excellent angiographic and clinical results, but this des has not been studied in unfavourable scenario (such as cto). the aim of the cibeles trial is to demonstrate the hypothesis that ees are equally effective in comparison with sirolimus-eluting stents in the treatment of cto, in terms of angiographic efficacy considered as in-stent late lumen loss.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 year-old. * a total occlusion (timi 0-1) with an estimated time of occlusion \> 2 weeks. * symptomatic or silent ischaemia, or viable myocardium. * the occlusion is suitable for percutaneous coronary intervention. * the guidewire has crossed the occlusion, and the occlusion has been dilated with balloon or other device. exclusion criteria: * acute myocardial infarction in the myocardial area supplied by the target vessel within 2 weeks before the inclusion in the study. * the lesion can not be crossed with the guidewire and balloon angioplasty. * the vessel has been previously treated percutaneously. * the lesion is not suitable for a 2.25-3.5 coronary stent implantation. * the patient is not willing to undergo an angiographic follow-up. * the patient has contraindications for prolonged double (aspirin plus clopidogrel) anti-platelet therapy (e.g. allergy to aspirin, need for chronic oral anti-coagulation, or scheduled surgical intervention within 12 months. * pregnancy or absence of pregnancy test in women of childbearing age. * chronic renal failure (creatinine plasmatic values \> 3.0 mg/dl). * plasmatic platelet count \ 700.000 mm-3. * the patient has a severe non-cardiac disease that limits his/her life expectancy to \< 1 year. * the patient is currently included in other randomized trial.

Keywords: coronary stent. restenosis. coronary artery disease. chronic total occlusion.
education against tobacco randomized trial in brazil

Conditions: Tobacco Prevention

Summary: a two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention education against tobacco on the smoking behavior of adolescents in 7-11th grade of secondary school. the primary endpoint is the change in smoking prevalence between the two groups.


Eligibility criteria:
inclusion criteria: * visiting grades 7-11 of a regular public secondary school in brazil. exclusion criteria: * not fulfilling inclusion criteria.

Keywords: tobacco prevention
exposure of bisphenol analogues in chronic kidney disease and dialysis patients

Conditions: Chronic Kidney Diseases; Hemodialysis Complication

Summary: in this retrospective study, the serum levels of bisphenol a (bpa) and three bpa analogs, namely, bisphenol b (bpb), bisphenol s (bps), and bisphenol f (bpf), in patients with ckd, patients on dialysis therapy and healthy control were investigated to find out if bpa and bpa analogs accumulates in patients with chronic kidney disease (ckd), and if hemodialysis filters contribute to bisphenol burden in patients on hemodialysis (hd).


Eligibility criteria:
inclusion criteria: * age 18; informed consent exclusion criteria: * absence of active inflammatory, infectious, malignant diseases, acute chronic kidney disease, or pregnancy at the initiation or during the study

Keywords: bisphenol human exposure chronic kidney disease blood purification
omarigliptin (mk-3102) clinical trial - placebo- and sitagliptin-controlled monotherapy study in japanese patients with type 2 diabetes mellitus (mk-3102-020)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of omarigliptin 25 mg weekly. the primary hypotheses are that after 24 weeks: 1) omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated hemoglobin (hba1c) compared with placebo, and 2) the mean change from baseline in hba1c in participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.

the treatment period is composed of a 24-week double-blind period (phase a) and a 28-week open-label period (phase b). participants will receive in phase a: omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo and in phase b: omarigliptin 25 mg once weekly.

Eligibility criteria:
inclusion criteria: * has type 2 diabetes mellitus exclusion criteria: * history of type 1 diabetes mellitus or a history of ketoacidosis * history of any of the following medications: thiazolidinediones and/or insulin within 12 weeks prior to study participation, omarigliptin and/or sitagliptin anytime
safety and pharmacokinetics of mci-186 in subjects with acute ischemic stroke

Conditions: Acute Ischemic Stroke (AIS)

Summary: the objectives of this study are to assess the safety, tolerability and local tolerance, and to investigate the plasma levels and terminal elimination half life of mci-186, and to review the routine clinical and neurological assessments data of mci-186 in subjects with acute ischemic stroke.


Eligibility criteria:
inclusion criteria: * full functional independence prior to the present stroke (as evidenced by a pre-morbid modified rankin scale score of 0-2 * clinical diagnosis of acute stroke with ct scan ruling out intracranial hemorrhage * onset of symptoms within 1-24 hours of commencement of infusion of study drug * measurable deficit on nihss (as evidenced by a score of 3-15) * full consciousness (i.e. the score for nihss item 1a=0) * written valid informed consent is obtained from the subject or his/her next of kin or legal representative if the subject is fully conscious (i.e. the score for nihss item 1a = 0) but unable to read and/or sign the icf, in accordance with national legislation and local irb requirements exclusion criteria: * subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition * subjects with severe illness with life expectancy less than 6 months * body weight in excess of 120 kg * subjects who have received rtpa or other thrombolytics (e.g. urokinase, streptokinase, reteplase, tenecteplase) within the previous 24 hours * likelihood of forbidden concomitant therapy such as vascular surgery, coronary artery bypass graft (cabg), valve replacement, or carotid endarterectomy (cea) * evidence of cerebral herniation * subjects with confounding neurological diseases such as dementia * subjects with cadasil, moya moya, or carotid dissection * subjects who have experienced a stroke within the previous 3 months (note: subjects who have recently experienced a tia, but whose premorbid mrs prior to their stroke is 0-2, will be allowed to enter the study) * evidence from admission imaging tests of infarction involving \>1/3 of mca territory, or entire aca territory involvement, or internal carotid artery (ica) occlusions without coexisting separate occlusion of the middle cerebral artery (because of the difficulty distinguishing between chronic and acute ica lesions in such subjects) * pathology other than cerebral infarction on any admission imaging tests (e.g. ich or sah, av malformation, cerebral aneurysm, or cerebral neoplasm) * current or previous known excessive alcohol use or dependence * current known illicit drug use or dependence * participation in a previous clinical study within 30 days * subjects unlikely to be able and willing to attend all study follow-up visits * any other conditions which in the opinion of the investigator deem the subject ineligible for inclusion * females who are pregnant or intend to become pregnant or subjects (male and female) who do not agree to use effective contraception for 3 months after end of treatment
study of low-magnitude, high-frequency vibration treatment on osteoporotic hip fracture healing

Conditions: Hip Fracture

Summary: osteoporotic hip fracture is common in elderly. as a result of aging population in hong kong, the total number of hip fracture cases is anticipated to increase substantially in the future, and therefore draw more resources in hospitals and healthcare cost. osteoporotic hip fracture usually causes severe pain and takes long time (4-8months) to recover due to impaired healing capability in osteoporotic bones and limited mobility. consequently, the patients will recover very slowly as a result of low physical activities to provide inadequate mechanical stimulation. it is also known that mechanical, vascular and biological factors are the keys for fracture healing. low-magnitude, high-frequency vibration (lmhfv) treatment is a biophysical intervention to provide whole-body vibration signals for mechanical stimulation, which has been proven to be good in enhancing bone and muscle performance, as well as blood circulation. our previous study of lmhfv on femoral fracture in rats showed acceleration of fracture healing, resulted from enhanced callus formation and maturation. application of lmhfv on osteoporotic fractures could shorten the period of complete callus bridging by 30%. our clinical trial on normal elderly also demonstrated improved muscle performance with good compliance, which is also a critical factor for fracture healing. in this study, the investigators therefore hypothesize that lmhfv can enhance hip fracture healing by enhancing fracture impaction, maintaining bone mineral density, enhancing muscle recovery, thus improving implant mechanical stability and rehabilitation in elderly patients. the hip fracture elderly patient will be recruited and randomized into control or treatment group. they will be assessed on the fracture healing at fixed time point. the findings of this study will provide very useful scientific data to support the application of lmhfv for hip fracture patients.the ultimate goal is to enhance the fracture healing and rehabilitation in elderly patients.


Eligibility criteria:
inclusion criteria: * unilateral hip fracture patients older than 65 years old * patient fixed with dynamic hip screw exclusion criteria: * unstable vital signs, large amount of drainage, or wound infection postoperatively * having of hormone replacement therapy or drug treatment known to affect bone metabolism or cause spontaneous bone loss * having hypo- or hyperparathyroidism and hypo-, hyperthyroidism, renal or liver disease * cannot tolerate or complication occurs during study * patients whose fracture is due to underlying disease, secondary to malignancy

Keywords: bone mineral density vibration rehabilitation fracture healing rate
haemostasis and therapeutic hypothermia

Conditions: Hypothermia; Heart Arrest

Summary: the purpose of this study is to investigate, if the haemostasis is impaired in cardiac arrest patients during therapeutic hypothermia compared with normothermia.

treatment with mild therapeutic hypothermia, 32-34 °c for 12-24 hours, has shown to improve the neurologic outcome in comatose survivors of out-of-hospital cardiac arrest. hypothermia is suspected to inhibit haemostasis and therefore cardiac arrest patients with a risk of bleeding are not treated with therapeutic hypothermia. however, the impact on the coagulation system during mild therapeutic hypothermia, has not yet been fully investigated. the investigators aim to investigate if mild therapeutic hypothermia influences haemostasis. we are including survivors of cardiac arrest, who are treated with hypothermia for 24-48 hours. blood will be sampled during hypothermia and secondly during normothermia. 30 minutes after the blood are sampled it will be analyzed using a sensitive low-tissue-factor assay with rotational thromboelastometry (rotem®). all the dynamic coagulation parameters obtained on the rotem® at hypothermia and normothermia, respectively, will be compared.

Eligibility criteria:
inclusion criteria: * treatment with therapeutic hypothermia, for minimum 24 and up to 48 hours, due to cardiac arrest. exclusion criteria: * age \<18 years.

Keywords: thromboelastometry haemostasis hypothermia heart arrest
hla sensitization in severely burned patients

Conditions: Severely Burned Patients

Summary: primary goal of this study is the analysis of hla (human leucocyte antigen) formation in severly burned patients. potential hla triggers in the treatment of severely burned patients are blood products, assist devices or temporary allogeneic skin. besides that, inflammatory markers, such as wbc (white blood cell count), crp (c-reactive protein), pct (procalcitonin) and two novel biomarkers (psp (pancreatic stone protein), st2) are to be investigated in severely burned patients.


Eligibility criteria:
inclusion criteria: * severely burned patients in need for hospitalization exclusion criteria: * hematologic diseases * cancer
ocular effects of scleral lens wear on dry eye patients

Conditions: Dry Eye

Summary: the purpose of this study is to investigate the effects of scleral contact lens wear on a de population using coated (hydra-peg) and uncoated (control) lenses. symptoms of de, quality of the tear film, quality of life, epithelial and overall corneal thickness, vision and comfort will be assessed before and after dispensing and wearing the lenses for four weeks.


Eligibility criteria:
inclusion criteria: a person is eligible for inclusion in the study if he/she: * is at least 18 years of age and has full legal capacity to volunteer. * has read, understood, and signed the information consent letter. * has been diagnosed with dry eyes. * has reduced tear break up time (nitbut) and/or reduced tear meniscus height (tmh), clinical sign of dry eye disease and contact lens discomfort or is symptomatic of dry eye. * is willing and able to follow instructions and maintain the appointment schedule. * has greater than 13 points on the osdi. * has greater than 4 points on the standardized patient evaluation of eye dryness (speed). exclusion criteria: a person will be excluded from the study if he/she: * is using any topical medications that will likely affect the study outcome. * has undergone any form of corneal surgery. * has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study. * has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye not related to the signs of dry eye. * has any clinically significant lid or conjunctival abnormalities and active neovascularization on the cornea. * anatomic variations of the conjunctiva that can impair proper scleral or soft contact lens wear/fitting * ocular pathology other than dry eye (e.g. glaucoma, macular degeneration) which may significantly impact visual function and assessment. * is participating in any other type of eye related clinical or research study. * has any active ocular infection and may require topical medications. * currently taking any systemic medication that may affect the study outcome. * is pregnant * has been diagnosed, recovered, or tested positive but asymptomatic with covid-19.
acz885 in type 1 diabetes mellitus

Conditions: Diabetes Mellitus; Diabetes Type 1

Summary: this study will assess the safety and efficacy of acz885 on stimulated c-peptide during a mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes within 3 months of visit 1 and on a stable insulin regimen * presence of at least one diabetes-related autoantibody * qualifying c-peptide value in a mixed meal test at visit 1 * willing to not have vaccination with a live vaccine for 18 months, from 3 months before visit 1 until 3 months after the last dose of study drug * body weight of at least 30 kg exclusion criteria: * women of child-bearing potential unless a highly effective method of birth control is used (such as combined oral contraceptives, intrauterine devices, etc) * immunodeficiency * active infections or febrile illness within 3 days before visit 1 * major dental work within 8 days before visit 1 * positive test for tuberculosis at visit 1 * use of medications other than insulin for the treatment of diabetes other protocol-defined inclusion/exclusion criteria may apply

Keywords: acz885 diabetes type 1 c-peptide
a comparison of the outcomes in fortiva and strattice mesh

Conditions: Ventral Hernia

Summary: a comparison of ventral hernia repair with strattice and fortiva mesh.primary the study team aims to determine the hernia recurrence rates for rti surgical biologic mesh (fortiva) compared to strattice. also the study team aims to determine the mesh related complications for rti surgical biologic mesh (fortiva) compared to strattice

this study will be a prospective, matched study of patients using fortiva biologic mesh to determine the rates of hernia recurrence and mesh related complication compared to strattice mesh. patients who meet the inclusion and exclusion criteria will be prospectively enrolled to receive a ventral hernia repair (vhr) using fortiva biologic mesh and will be compared to a retrospective cohort of patients with a vhr that utilized strattice mesh. patients will be propensity matched in a 1:3 (fortiva : strattice) fashion based on age, sex, and hernia defect size.

Eligibility criteria:
inclusion criteria: * ventral hernia requiring surgical repair exclusion criteria: * pregnant women

Keywords: ventral hernia surgical biologic mesh hernia complications
the dallas hereditary spherocytosis cohort study

Conditions: Hereditary Spherocytosis

Summary: the purpose of this study is to 1. better characterize the short term and long term natural history of hereditary spherocytosis (hs) including diagnosis, complications, and indications for and response to splenectomy 2. evaluate and describe the health-related quality of life in children with hs.

patients with a new or established diagnosis of hs seen at children's medical center will be asked to enroll in the study. previous and current medical records will be reviewed to systematically catalogue their history of hs, including diagnosis, complications, hospitalizations, medications and laboratory data. health-related quality of life questionnaires will be given to the patients and their parents at enrollment and periodically during the follow-up. those who agree will have up to three small samples of blood collected and frozen for future laboratory studies of complications associated with hs and/or splenectomy. we anticipate enrolling approximately 200 children and young adults with hs in this study and following them until adulthood (age 18-21 years).

Eligibility criteria:
inclusion criteria: * diagnosis of hs with or without prior splenectomy * age 0 - 21 years * spanish-speaking subjects are eligible to participate exclusion criteria: * unable to provide contact information for follow-up

Keywords: hs congenital hemolytic anemia splenectomy quality of life