Kornimate/medical-research-clean huggingface dataset:
evaluation of technology-based stress reduction techniques prior to vascular access

Conditions: Stress, Emotional

Summary: preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, postoperative pain, agitation, sleep disturbances, and negative behavioral changes. the purpose of this study is to determine if a non-invasive distracting devices (virtual reality headset) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before vascular access among hospitalized children undergoing vascular access prior to anesthesia, procedures, surgery, blood draws, port access, or peripheral iv placement. the anticipated primary outcome will be reduction of child's anxiety during and after vascular access.

anxiety among children undergoing vascular access is common. not only is high anxiety traumatic, but research indicates that high anxiety in children before surgery leads to adverse outcomes such as increased pain and analgesics requirements, delayed hospital discharge, and maladaptive behavioral changes. treating anxiety may decrease any of these undesirable behaviors. in this study, investigators hope to determine if technology based distractions (vr headsets) are more effective than standard care for preventing high anxiety before vascular access. as a secondary aim of the study, we seek to determine if the use of technology based distraction will result in higher parent and patient satisfaction, decreased fear, and increased compliance, while monitoring for side-effects of the intervention.

Eligibility criteria:
inclusion criteria: 1. be between ages of 7-18 years of age 2. have comprehension of instructions in the english language 3. have parental consent 4. pediatric patient must be undergoing non-emergent vascular access at lucile packard children's hospital in one of the 6 previously defined care areas (please see study design in section 16). 5. children who are normally healthy (asa i) or have a mild systemic disease (asa ii,iii)- exclusion criteria: 1. significant cognitive impairment/developmental delays per parental report or h\&p. 2. children with asa iv (severe systemic disease that is a constant threat to life) or asa v (unstable patients not expected to survive \>24hours or without the operation) 3. h/o severe motion sickness, nausea, seizures
serial hybrid atrial fibrillation ablation

Conditions: Atrial Fibrillation

Summary: treatment of (long-standing) persistent atrial fibrillation (af) remains cumbersome and the surgical (epicardial) approach seems to be the most effective. still, however a significant amount of failures exist which is mostly due to incompleteness of the surgical ablation lines. checking, and if necessary additional ablation, of these lines afterwards endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this problem.


Eligibility criteria:
inclusion criteria: * patients are screened and accepted for pulmonary vein isolation according to the current guidelines * long standing persistent or persistent af as defined in the guidelines * left atrial size needs to be more than \>46 mm on long axis or \>35 cc/m2 * chadsvasc score should be more than 0 as an indicator of a substantial substrate for atrial fibrillation. exclusion criteria: * significant coronary artery disease has to be excluded as a trigger for af by means of cardiac ct, if necessary a coronary angiogram will be performed. * previous pvi ablation (epicardial or endocardial) or cardiac surgery. * significant valvular disease present on echo. * concomitant cardiac surgery needed.

Keywords: atrial fibrillation pvi vats ablation hybrid
colonoscopy screening using a novel slim colonoscope - a randomized controlled trial

Conditions: Colorectal Cancer; Adenomas

Summary: the purpose of this study is to compare the performance of a new prototype colonoscope with a standard colonoscope used world-wide today. the prototype colonoscope is more flaccid with a smaller diameter than the standard colonoscope. the hypothesis to be tested is that the prototype will improve negotiation of sharp bends and inflict less discomfort or pain to the patient. both colonoscopes are manufactured by the same company.


Eligibility criteria:
inclusion criteria: * persons included in the nordicc trial are eligible for inclusion * for information about the nordicc trial see clinicaltrials.gov nct00883792 exclusion criteria: * pregnancy * persons younger than 18 years * persons unable to comprehend the information given * not possible to start the examination without prior administration of sedation/analgesics

Keywords: colonoscopy performance pain discomfort screening colorectal cancer colorectal cancer screening, diagnostics of adenomas
cardiovascular consequences of intermittent hypoxia in healthy subjects

Conditions: Sleep Apnea Syndrome

Summary: the study is a prospective field evaluation to assess the effects of the chronic intermittent hypoxia exposure in 12 healthy humans. precisely, the study was designed to : set up a new model of chronic intermittent hypoxia (cih) applied to healthy human. this cih is mimicking the cih undergone by patients suffering from sleep apnea syndrome. evaluate the cardiovascular effect of cih. neuronal and humoral sympathetic control, blood pressure control, vascular resistance. evaluate the sleep quality, the ventilation under exposure and the long terms effect on ventilation control of cih (central and peripheral chemoreflex). investigates the biological aspects of cih exposure.


Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * any history or significant medical condition

Keywords: blood pressure hypertension sympathetic control chemosensitivity baroreflex
omega-3 and aspirin in periodontal regeneration

Conditions: Periodontal Disease

Summary: to evaluate the efficacy of systemic administration of omega 3 pufa plus low dose aspirin as an adjunctive therapy to regenerative modality of grade ii furcation defects in periodontitis patients.

in this study, we tested the hypothesis that the administration of omega 3 pufa plus low dose aspirin would augment the results following regenerative therapy of furcation defects in chronic periodontitis patients.

Eligibility criteria:
inclusion criteria: * suffering moderate to sever chronic periodontitis and displaying at least a single grade ii furcation defect according to glickman's classification 1953, determined by both clinical and radiographic examinations; * free from systemic diseases known to influence the periodontal condition and not receiving any medication known to affect the periodontal status; * have not receive any periodontal therapy for a minimum of 6 months prior to the study. exclusion criteria: * known hypersensitivity or allergy to one of the used medications * pregnancy or lactation * heavy smoking (more than 10cigarretes/day) * history of alcohol abuse * participation in other clinical trials

Keywords: bone allograft il-1 il-10 periodontal regeneration omega-3 aspirin
eat: a reliable eating assessment technology for free-living individuals

Conditions: Wearable Electronic Device

Summary: this study utilizes a small, privacy-conscious wearable device intended to monitor human behaviors. the device is worn around the neck, capturing the wearer's head and upper torso within its field of view, and records color images without audio. participants visit the lab for consent, device training and recording of several activities using the device. participants will then take the device home and wear it during their normal schedules for four "active" weeks. during each active week, participants will wear the device, keep a log of all food and drink items consumed throughout the day and participate in unscheduled phone calls with a dietitian. a "washout" week occurs in between each active week in which participants do not need to complete any study tasks. alongside the device, we have included three privacy filters (blur, edge, and avatar) capable of obscuring faces and objects seen in the device-captured images. all participants will be subject to unfiltered recording during their first week followed by a different filter each following active week in a random order. at the start of each active week, participants view an example of what their recorded images will look like that week (given the privacy filter). at the end of the seven weeks, participants will return the device and provide the lab with feedback on the design of the device and its privacy-preserving features.


Eligibility criteria:
inclusion criteria: * bmi greater than or equal to 18.5 * chicago metropolitan area resident * able to speak, read and write in english * has a valid phone number * owns a smartphone * has access to a computer exclusion criteria: * pregnant or breastfeeding individuals * experienced significant weight loss/gain in the last three months (25 lbs or more) * diagnosed with or has a family history of genetic obesity syndromes (e.g., prader-willi, bardet-biedl, cohen syndrome) * member of household enrolled in the study

Keywords: wearable electronic device behavior eat privacy camera obesity obfuscation filter cartoon blur raw edge burden wearer bystander monitor bmi calories tool algorithm rgb thermal data health chest
ptrg-des consortium

Conditions: Coronary Artery Disease; Clopidogrel, Poor Metabolism of; Platelet Dysfunction; Stent Thrombosis

Summary: the ptrg-des consortium is a coalition composed of multi-center, real-world registries including cad patients treated with des in south korea. from 9 academic registries in korea, a total of 13,160 patients were enrolled for this database between july 2003 and august 2018. the aim of the study was to investigate long-term prognostic implications of platelet function and genotypes after des implantation for significant cad in south korea.

the investigators enrolled patients treated with des during dapt including clopidogrel who had at least one of verifynow test (pru and aru) and genotyping. in this consortium, the investigators tried to find the unique characteristics of east asians based on platelet function, genotype and inflammatory markers.

Eligibility criteria:
inclusion criteria: * consecutive patients at every centre successfully treated with one or more des approved by the us fda or ce mark and who were adequately loaded with clopidogrel were eligible for enrolment, regardless of patient or lesion complexity. exclusion criteria: * the occurrence of a major complication during the procedure or before platelet function testing, or if bypass surgery was planned after pci. * any p2y12 inhibitor other than clopidogrel * pci strategy other than des * needed oral anticoagulant (e.g. atrial fibrillation)

Keywords: asian population verifynow assay genotype inflammation
this study is to describe and evaluate patients in finland treated with tofacitinib for the treatment of ulcerative colitis using real world data.

Conditions: Ulcerative Colitis

Summary: the aim of this study is to describe and evaluate clinical outcomes, treatment lines, and to identify the key characteristics of the patients treated with tofacitinib.


Eligibility criteria:
inclusion criteria: * xeljanz (tofacitinib) usage for ulcerative colitis * diagnosis of ulcerative colitis (icd-10: k51.0, k51.1, k51.2, k51.3, k51.5, k51.8, k51.9) between january 2010 and december 2021 (incident or prevalent). exclusion criteria: * age \< 18 years at the start of tofacitinib use * use of tofacitinib before reimbursement (1.3.2019) * \< 8 weeks of treatment with tofacitinib at the start of data mining * history of panproctocolectomy, ipaa or ileostomy.
husk fiber intervention on metabolic health of centrally obese school teachers

Conditions: Metabolic Disease

Summary: a group of 120 school teachers (male=60, female=60) was divided into four subgroups for sixteen weeks of an interventional study. one group was kept in control while the other three groups were assigned intervention. one group was assigned intervention of lifestyle modification (lsm), the other group assigned the intervention of 5 gm psyllium husk fiber (psh) two times a day, and the third group assigned the combined intervention of lsm \& psh. each group comprised of 30 subjects with equal gender bifurcation (15 male and 15 female).

the school teachers who qualified for the initial screening and eligibility criteria were formally enrolled in the intervention. an informed consent form was signed by each subject explaining the data privacy and the subject's obligation. school teachers with lifestyle modification were advised to adhere to three major components, i.e., diet modification, physical activity, and behavioral therapy. subjects in the psyllium husk fiber group were assigned the consumption of 5gm psyllium husk fiber (in swelled form) two times a day, i.e., 30 minutes before breakfast and 30 minutes before dinner. subjects in the combined group of psyllium husk fiber and physical activity were assigned both the intervention of psyllium husk fiber @ 5gm two times a day, 30 minutes before breakfast and dinner in swelled gel form with the combination of lifestyle modification, while one group remained as control (without any intervention).

Eligibility criteria:
inclusion criteria: * school teachers aged 40-60 years (male and female) * central obesity (where central obesity for asians is defined as the waist circumference for men ≥ 90 cm and for women ≥ 80 cm * with no history of any chronic disease like hypertension, diabetes, cardiovascular diseases, taking of any regular medication, food allergies, smoking * physical disabilities impairing the food intake and mobility, qualified the inclusion criteria. exclusion criteria: * pregnant or lactating female school teachers were also excluded during screening. * subjects with an allergy to psyllium husk fiber, history of drug abuse, or any psychological or emotional disorder that might prevent the completion of the study were also excluded.

Keywords: insulin resistance, high sensitive c reactive protein lipid profile sleep quality analysis abdomens and epigastric health
assessment of novel metabolic imaging modalities as a predictor of therapeutic efficacyiin glioblastoma (gbm)

Conditions: Glioma; GBM

Summary: the goal of this study is to evaluate the prognostic capacity of dmi in a trial assessing the efficacy of adding bpm31510, a lipid nano dispersion of coq10 to standard treatment of glioblastoma (gbm).


Eligibility criteria:
inclusion criteria: * any participant that consents to entry into the phase ii bpm31510 parent study (bpm31510iv-11) * women of childbearing potential must have a negative pregnancy test * ability to understand and the willingness to provide written informed consent. exclusion criteria: * refuse to have an iv * allergy to mri contrasts * diabetic patients who are taking insulin
pharmacokinetics and adhesion of lidocaine topical system 1.8% with water exposure

Conditions: Healthy

Summary: the objectives of this study are to evaluate the adhesion performance and pharmacokinetics of ztlido (lidocaine topical system) 1.8% during swimming, showering, and under normal conditions.

in this phase 1, open-label, three-period crossover study, 24 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. during each treatment period, subjects have one lidocaine topical system applied to their back for 12 hours with a 4-day washout between treatments. in each treatment period, the subject will either swim (treatment a), shower (treatment b), or refrain from these activities (treatment c) while wearing the topical system. blood samples for lidocaine pk will be collected pre-dose until 24 hours. adhesion will be monitored throughout the wear time and skin irritation will be assessed the topical system is removed.

Eligibility criteria:
key inclusion criteria: * must be healthy based on medical history, laboratory work, and physical exam * body mass index ranging between 18.0-30.0 kg/m2, inclusive * capable of unaided swimming * if childbearing potential, use of acceptable form of birth control * in case of females of childbearing potential, have a negative serum pregnancy key exclusion criteria: * allergy or known hypersensitivity to lidocaine, amide-type local anesthetics or any component of the product formulation * any major medical illness 3 months prior or any significant history or ongoing chronic medical illness affecting the major body systems, including the skin * subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin) * use of antiarrhymthic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application. * history of addiction, abuse, or misuse of any drug * use of nicotine-containing products within 30 days
swiss multiple sclerosis cohort-study

Conditions: Multiple Sclerosis

Summary: the swiss ms cohort study (smsc) is a multicentre cohort study that involves 8 swiss multiple sclerosis centres. the key aims of the smsc are 1. to maintain a long-term cohort for an undefined duration of patients with multiple sclerosis (ms), neuromyelitis optica spectrum disorder (nmosd) and myelin oligodendrocyte glycoprotein antibody-associated disease (mogad) in switzerland. this requires effective measures to limit drop-outs and the continuous recruitment of ms patients and 2. to conduct a systematic follow-up with standardized, high quality collection of clinical and magnetic resonance imaging (mri) data, as well as body fluids. the significant heterogeneity within the diagnostic entity and phenotype of ms is incompletely understood. a central and necessary prerequisite of further advance is a sufficient amount of high quality clinical and paraclinical (imaging, body fluids) patient data. nested projects will address specific research topics, and facilitate collaboration of the most qualified investigators within the group of smsc investigators. the nested projects will focus on the: 1. development and validation of diagnostic and prognostic markers of spontaneous disease evolution and therapeutic response. 2. exploration of the safety and impact on long-term disability of existing and next generation ms treatments 3. individualized therapy: a number of highly active but potentially also harmful therapies have lately been established for the treatment of ms. to date, due to the lack of individual prognostic markers patients may not receive aggressive therapy due to safety concerns, or patients with benign disease may receive expensive and potentially harmful treatments without the need for it. 4. evaluation of intervention effects by conducting embedded pragmatic trials using the smsc as data-infrastructure.


Eligibility criteria:
inclusion criteria: * fulfilling the diagnosis of radiologically isolated syndrome (ris), clinically isolated syndrome (cis), relapsing-remitting multiple sclerosis (rrms), secondary-progressive ms (spms), primary-progressive ms (ppms), neuromyelitis optica spectrum disorder (nmosd) or myelin oligodendrocyte glycoprotein antibody-associated disease (mogad) according to established criteria * intending to attend hospital visits every 6 months (+/- 45 days) or 12 months (+/- 45 days) (facultative cranial mri every 12 months) over a longer period (at least 5 years) * intending to give blood for biobanking every 6 or 12 months during hospital visit or as close as possible to the visit (+/- 8 days) inclusion criteria are crafted to identify a population of patients with ms, nmosd or mogad particularly suitable for analysing disease evolution and associated factors, treatment dynamics, and the long-term safety and efficacy profile of disease-modifying drugs. there are no specific exclusion criteria.

Keywords: ms key phases of disease evolution ms new treatment options
house dust mite observational study

Conditions: Rhinoconjunctivitis

Summary: a field study to observe symptom scores and allergy medication usage in subjects with a history of house dust mite-induced rhinoconjunctivitis

house dust mites (hdm) are arachnids that infest bedding, carpet, upholstered furniture and fabric. like many other allergens, exposure to hdma in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. in contrast to other allergens, there is evidence that hdma leads to the development of asthma, in addition to exacerbating pre-existing asthma in hdm-sensitised patients. the proposed observational study is designed to gather information on subjects with hdm-related rhinoconjunctivitis.

Eligibility criteria:
inclusion criteria: * male or female, aged 18-65 years * a history of moderate to severe rhinoconjunctivitis (sneezing, rhinorrhoea, itchy nose, nasal blockage, and/or itchy/watery/red/sore eyes) consistent with allergy to hdm for at least 1 year. * non-asthmatic, or asthma controlled by step 1 or 2 treatment as defined by gina for at least one month. * subjects must have a 7-day reflective trss (i.e., reflective over the previous 7 days) of ≥12 and must have a score of ≥2 in at least two of the individual symptom components. * subjects must have der p or der f specific ige ≥0.35 ku/l as measured by immunocap®. a blood draw for hdm-specific ige must be performed during the screening period. * subjects must have der p or der f specific ige ≥0.35 ku/l as measured by immunocap®. a blood draw for hdm-specific ige must be performed during the screening period. exclusion criteria: * clinically significant confounding symptoms of allergy to relevant local seasonal allergens (e.g., ragweed, mugwort, tree, grass, mountain cedar, mould) and cannot complete the screening and observation period outside the respective allergy seasons. * previous immunotherapy treatment with any hdma for more than 1 month within 5 years prior to screening

Keywords: hdm allergy rhinoconjunctivitis
comparison mydriasis by mydrane with topical drop application

Conditions: Cataract

Summary: the primary aim of the study is to compare the effectiveness of the intracameral application of mydrane® (standardized combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) with the preoperative topical application (tropicamide 0.5% and phenylephrine 10%). to evaluate the steadiness of the dilating effect on the pupil, the ratio of eyes without necessity for further pupil dilating procedures to perform the capsulorhexis is assessed.


Eligibility criteria:
inclusion criteria: * male and female patients between the age of 50 to 100 years * day-hospital and inpatient care * clinically significant opacity of the lens with indication for cataract surgery on both eyes * lack of previous ophthalmic surgeries * lack of relevant ophthalmic conditions: pseudoexfoliation syndrome, eye injuries, present inflammation (in terms of uveitis, endophthalmitis and iridocyclitis), restricted mydriasis (pupil diameter below 7mm after application of tropicamide 0.38% and phenylephrine hcl 2.5% - at preoperative examination), elevated intraocular pressure, alpha-receptor inhibitor intake (e.g. tamsulosin) due to impeded mydriasis exclusion criteria: * allergic to phenylephrine, tropicamide, sodium metabisulfite, disodium edetate, sodium hydroxide, hydrochloric acid, lidocaine hydrochloride, sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate * allergic to anesthesia (amide type) * allergic to atropine derivates * heart disease, tachycardia, hypertensive crises * aneurism of big vessels * untreated hyperthyroidism * untreated closed angle glaucoma and narrow angles with tendencies to glaucoma by intake of mydriatic drugs * pregnancy, breast feeding and premenopausal women