Kornimate/medical-research-clean huggingface dataset:
study of application of transcutaneous trigeminal nerve stimulation and sound fusion stimulation on tinnitus

Conditions: Tinnitus

Summary: this study aims to evaluate the efficacy of applying transcutaneous trigeminal nerve stimulation (nueyne-t30, nueyne-t100) and sound fusion stimulation on tinnitus.

duration of study period (per participant): screening period (-7\~0 days), intervention period (30 days) patient needs to visit site at least 3 times (screening, v1, v2). v1 can be done with screening visit. tele-visit should be done on day 15.

Eligibility criteria:
inclusion criteria: * adults suffering from tinnitus * participants must be 19 to 70 years of age, at the time of screening * patient who suffers from tinnitus symptom more than 3 months and scores more than 18(criteria of mild) in tinnitus handicap inventory (thi) examination * patients with a hearing threshold of 70db or less when calculated using the quadrant method in the pure tone audiometry * a person who has no physical or mental restrictions in participating in clinical trial * those who voluntarily agreed to participate in clinical trials * a person who has no pregnancy plan and has agreed to the contraceptive plan for infertile women during the intervention period of clinical trial exclusion criteria: * a person who does not meet the inclusion criteria * a person who has difficulty communicating and conducting examinations. * the disease of the outer or middle ear or central nervous system. * subjects who have difficulty conducting clinical trials due to intellectual or cognitive impairment * pregnant or lactating women * a person who cannot understand or read icf (illiterate or foreigner) * a person who received tinnitus treatment (blood circulation enhancer, tranquilizer, tinnitus masker, biofeedback etc.) within 2 weeks of baseline or plans to receive it. * a person who is difficult to participate in a clinical trial according to the researcher's judgment. (e.g., heart-related problems, seizure, epilepsy. patients transplanted metal or electronic device in head \& neck. patient suffering from unknown pain. patients who are warned not to use out clinical trial device or is prohibited from using it.)
trio cto (taiwan research initiative on coronary total occlusion)

Conditions: Chronic Total Occlusion (CTO)

Summary: coronary chronic total occlusions (cto) present a significant challenge in the field of interventional cardiology. these complex lesions, characterized by complete blockage of a coronary artery for a prolonged duration, often require specialized techniques and strategies to achieve successful revascularization.

using this consortium, we will establish a multicenter cohort to evaluate the clinical parameters, angiographic characteristics, interventional techniques, and clinical outcomes involved in coronary cto intervention. 3 subprojects are listed here. subproject 1 intends to develop a novel algorithm integrating antegrade and retrograde scoring system to optimize the cto intervention and determine the optimal timing for primary retrograde approach. current algorithm for cto intervention. subproject 2 aims to examine the strategies and outcomes of cto involving bifurcations. bifurcation cto lesions present unique challenges due to their complex anatomy. opening of the main vessel while preserving important branches is crucial for ensuring favorable long-term clinical prognosis. this subproject will investigate different strategies and devices employed in bifurcation cto pci to assess their efficacy and safety outcomes. subproject 3 investigates the treatment strategies for right coronary artery (rca) ctos with concomitant left main disease, which present a unique and intricate scenario, requiring careful consideration of revascularization strategies.

Eligibility criteria:
inclusion criteria 1. over 20 years old 2. chronic total occlusion confirmed by coronary angiography, and noted for more than 3 months exclusion criteria nil

Keywords: cto coronary chronic total occlusion coronary artery disease coronary intervention collateral channel
oral lesions in patients with eating disorders

Conditions: Eating Disorders

Summary: eating disorders (ed) are common among young. anorexia (an) and bulimia (bn) are the most prevalent ed. the american psychiatric association's guidelines state a 0.3% an prevalence among young girls and a 0.1 to 4.2% bn prevalence. men are not excluded: even if ed are more frequent in females (14-18 years), 1 man off to 10 can be diagnosed with ed. unfortunately, the onset age is decreasing. in the last few years, always more preteens patients are diagnosed with ed: they generally refer a garbled self perception of body image. ed can have oral manifestations, such as: mucosal lesions, dental erosion, glandular hypertrophy, xerostomia and salivary disorders, dental caries these are the most common manifestations observed in patients with eating disorders, after a routine dental visit. there is not strong evidence that dental caries may be directly related to disordered eating habits; as a matter of fact results are controversial. despite that, all the studies examined agree on the association between signs listed above and food disorders. univocal percentages have not been reported in the scientific literature. for instance, a systematic review, dated 2016, showed that dental erosion is diagnosed in 45% of ed people, while other studies documented 70% patients affected by erosion. another example reported is teeth hypersensitivity. according to some studies, 56% of ed patients reported such complaints, instead of other researches documenting 22% hypersensitivity impairment. as for dental caries, results are dissimilar. authors showed 78% ed subjects diagnosed with dental caries. other studies reported almost 50% patients with tooth decay, without statistically significant difference in the values between ed people and controls. all these differences are probably due to the different stages of eating disorders and diagnosis, and oral signs found. different ages are also considered. the primary aim of the study is to evaluate the prevalence of oral cavity lesions among people affected by eating disorders.


Eligibility criteria:
inclusion criteria: 1. diagnosis of ed 2. age between 10 and 18 years exclusion criteria: 1. parents or caregivers not understanding the italian language 2. patients affected by other systemic diseases

Keywords: eating disorders pral lesions prevention prevalence
48 hours esophagal ph-monitoring with and without gaviscon

Conditions: Gastroesophageal Reflux

Summary: at a esophagal ph-monitoring will the classic 24-hour measurement be extended to 48 hours. during the first 24 hours are the measurements without medication. after 24 hours the treatment will be started with gaviscon and will the next 24 hours the measurements under the medication happen. normally is the medication required after the measurements. with this study the investigators will have multiple measurement points to compare.

this is an interventional, with questionnaires. 25 participants will be included. parents and children must be willing to have the esophagal ph-monitoring for 48 hours instead of 24 hours. the restrictions are (like any other esophagal ph-monitoring) : do not detach the probe, no bath or shower, no bouncy castle, no swimming pool, .... give your child time to get used to the probe. give your child no carbonated beverages, limit sweets, avoid chewing gum! not study specific procedures : there will be placed a probe for the oesophagal ph-monitoring and this will be checked on children's radiology. study specific procedures : questionnaires at specific times : before start : sf 36 every 6 hours during 48hours : flacc satisfaction scale at the start, after 1 day and after 2 days flowchart time 0: obtaining icf, signed by both parents, placing of probe, explanation of questionnaires, completing sf36 and satisfaction scale time 6: flacc time 12: flacc time 18: flacc time 24: flacc, satisfaction scale, reading out ph monitoring from the first 24 hours, then starting of gaviscon in function of the result. the gaviscon is supplied by the service, at no cost to the patient time 30: flacc time 36: flacc time 42: flacc time 48: flacc, satisfaction scale, remove ph monitoring calculation of the number of participants : since there is never such a study was carried out, we started this pilot study. an analysis will be carried out after 15 patients. analysis of the results : the results of the first and second 24 hour data will be compared (automatically by computer analysis).

Eligibility criteria:
inclusion criteria: * children in whom a ph-monitoring was asked * pre school-age children * hospitalized children * parents have the informed consent signed. exclusion criteria : * children over 6 years

Keywords: impedance metry gaviscon
respiraconnosotros:a mobile application for covid-19 respiratory rehabilitation.

Conditions: Covid19

Summary: platform with a mobile application to encourage the performance of respiratory exercises, controlled and supervised by physiotherapists. it also includes recommendations, frequently asked questions and the possibility of contacting by chat or video calls with experts to solve possible doubts. currently, the application is ready for use, the registration of users and professionals is enabled and have 20 exercises divided into three intensity levels. it is available for all platforms (pc, android, ios). presents a simple deployment, accessible to the entire population and does not require installation. in the future, investigators will include more languages, a greater variety of exercises and even other types of therapies. investigators will also carry out the adaptation to functional diversity with subtitles and voice commands.


Eligibility criteria:
inclusion criteria: * respiratory affectation diagnosis * internet access to run the application exclusion criteria: * presence of contraindications to physical exercise or the lack of comprehensive ability to access the application will be considered.

Keywords: respiration disorders telerehabilitation breathing exercises complications
warm water versus room temperature water immersion colonoscopy

Conditions: Colorectal Cancer

Summary: water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. there was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials. the investigators have been using room temperature water (20-24°c) for water immersion and the investigators did not notice any drawback of it. in our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice. the primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not shorten it significantly. patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy will be also assessed.


Eligibility criteria:
inclusion criteria: * outpatient diagnostic colonoscopy * bowel prep with macrogolum * initial 2 mg of midazolam i.v. * signed informed consent form exclusion criteria: * planned therapeutic intervention * colorectal surgery in history * known inflammatory bowel disease or colorectal cancer * refusal of sedation

Keywords: colonoscopy warm water immersion cool water immersion
diurnal and nocturnal effect of travatan with sofzia preservative on intraocular pressure and ocular perfusion pressure

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this research study is to determine the diurnal and nocturnal effects of travoprost with sofzia (travatan z) on intraocular pressure and ocular perfusion pressure.

the investigators hypothesize that travatan z will significantly lower intraocular pressure and increase ocular perfusion pressure during both the diurnal and nocturnal period, during a 24-hour evaluation, compared to baseline. the investigators further hypothesize that the medication effects will persist at 72 hours after discontinuation of the drug.

Eligibility criteria:
inclusion criteria: * diagnosis of open-angle glaucoma or ocular hypertension, including pigment dispersion glaucoma and pseudoexfoliation glaucoma * age ≥ 18 or ≤ 90 years, of either gender, or any race/ethnicity exclusion criteria: * females who are currently pregnant or planning to become pregnant, as determined by history during the study period * diagnosis of any other form of glaucoma other than open-angle * schaffer angle grade \< 2 in either eye by gonioscopy * chronic, recurrent, or severe inflammatory eye disease * intraocular surgery within 6 months or laser within 3 months * history of active, recurrent, or chronic ocular infection with the herpes simplex virus * history of cystoid macular edema * inability to safely discontinue all ocular medications for 4 weeks * patients who smoke or have irregular daily sleep patterns * patients who have started or changed glucocorticoids therapy in the last 3 months * patients who are currently undergoing medical marijuana therapy * any use of a non-fda approved medication for glaucoma in the last 3 months
lifeseal™ pilot study in subjects undergoing circular stapled anastomosis created within 10 cm of the anal verge

Conditions: Rectal Cancer

Summary: a pilot study in subjects undergoing circular stapled anastomosis created within 10 cm of the anal verge.


Eligibility criteria:
inclusion criteria: 1. subject, or authorized representative, signed a written informed consent form 2. subject is 18 years or older 3. subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge. 4. if female - not be of child bearing potential, or be using acceptable contraception methods. 5. subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the sponsor. exclusion criteria: 1. subject has a history of hypersensitivity to porcine derived gelatin or collagen 2. subject participating in any other study involving an investigational (unapproved) drug or device. 3. subject with a bmi higher than 40 4. female subject states that she is pregnant or breast feeding 5. subject with asa status higher than 3 6. avastin use within 30 days prior to surgery 7. subject who underwent a prior pelvic anastomosis 8. subject is scheduled for another surgery during the follow up period of this study (not including stoma closure)
norepinephrine plus dobutamine versus epinephrine alone for the management of septic shock

Conditions: Septic Shock; Severe Sepsis; Infections

Summary: catecholamines infusion is a major component of septic shock management. international guidelines recommend that norepinephrine should be preferred to epinephrine, though phase iii trials are lacking. the present study aimed at comparing the efficacy and safety of norepinephrine plus dobutamine to that of epinephrine in adults with septic shock.

the french conference on consensus on catecholamines use in septic shock has underlined the importance of carrying out a clinical trial to clarify the use of epinephrine, norepinephrine and dobutamine in the management of multiple organ failure associated with severe sepsis. the main objective of the study was therefore to compare the effects of the combination of dobutamine and norepinephrine to those of epinephrine alone in patients with septic shock. in this purpose, patients were randomly assigned to receive either epinephrine or norepinephrine plus dobutamine and drugs were titrated to maintain blood pressure over 70 mmhg. main outcome was 28-day mortality.

Eligibility criteria:
inclusion criteria: * adults over 18 years * informed consent presenting from less than 7 days : * one or more infectious site * at least 2 of the following criteria: temperature \> 38°c or \ 20 breaths per min or paco2 \ 90 beats/min, white blood cell count \> 12,000/mm3 or \< 4,000/mm3 * at least 2 of the following criteria: pao2/fio2 ratio \ 2 mmol/l, platelet count \< 100,000 /mm3 and presenting from at least 24 hours: * systolic blood pressure \< 90 mmhg or mean blood pressure \< 70 mmhg (for at least 30 min); * 1000 ml fluid replacement or pulmonary capillary wedge pressure \> 12 mmhg * dopamine infusion at 15 µg/kg/min for at least 1 hour, or epinephrine or norepinephrine in first intention exclusion criteria: * pregnant woman * obstructive cardiomyopathy * acute coronary disease * non infectious shock * care limitation * white blood cell count \< 500 /mm3

Keywords: catecholamines septic shock
surgical innovations in treatment of clavicle fractures

Conditions: Complication

Summary: surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. it is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. therefore we developed a mini-incision technique using an average incision length of 4cm. the aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access.

surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. it is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. therefore we developed a mini-incision technique using an average incision length of 4cm. the aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access. therefore a prospective observational protocol was chosen.

Eligibility criteria:
inclusion criteria: all patients with fractures of the clavicle and indication for operative intervention using plate osteosynthesis ability to sign informed consent exclusion criteria: all other patients

Keywords: clavicle surgical intervention mini-incision plate osteosynthesis
a study to evaluate a mid add multi-focal soft contact lens

Conditions: Presbyopia

Summary: this study is to evaluate the product performance of the investigational ld127025 mf mid add soft contact lens compared to ciba vision's air optix aqua mf med add soft contact lenses when used among currently adapted soft contact lens wearers.


Eligibility criteria:
inclusion criteria * have physiologically normal anterior segments not exhibiting biomicroscopy findings grade 2 or greater and/or presence of infiltrates. * be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. * be correctable through spherocylindrical refraction to 42 letters (0.1 logmar) or better (distance, high contrast) in each eye. * require contact lens correction from -5.00 d to +3.00 d in each eye. * be presbyopic and require near add correction from +1.00 d to +1.75 d in each eye. * be an adapted monovision soft contact lens wearer or multifocal soft contact lens wearer or an adapted spherical soft contact lens wearer who also uses spectacles for near vision correction. * be willing to use a lens care system as required by the lens replacement schedule. * has a distance spherical equivalent refraction between -5.50 d and +3.00 d. exclusion criteria: * not correctable to 32 letters (0.3 logmar) in each eye with soft spherical contact lenses. * participated in any drug or device clinical investigation (within 14 days) prior to entry into this study and/or during the period of study participation. * women of childbearing potential if one of the following: pregnant, plans to become pregnant during study, is breast-feeding. * any grade 2 or greater finding during the slit lamp examination. subjects with corneal infiltrates of any grade are not eligible. * any scar or neovascularization within the central 4mm of the cornea. subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the investigator's judgment, does not interfere with contact lens wear, are eligible for this study. * any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * anisometropia (spherical equivalent) of greater than 2.00 d. * aphakic. * amblyopic. * allergic to any component in the study care products. * meet any of the following criteria: * ophthalmologist, od, optician, ophthalmologist's assistant/technician * employee of a market research firm * employee of manufacturer of contact lens or contact lens care products * ocular astigmatism of greater than 1.00 d in either eye. * have had any corneal surgery (ie, refractive surgery). * toric contact lens wearer. * have worn gas permeable (gp) contact lenses within the last 30 days or pmma lenses within the last 3 months. * have an active ocular disease or are using any ocular medication. * have any systemic disease currently affecting ocular health or which, in the investigator's opinion, may have an effect on ocular health during the course of the study. * using any systemic medications that will, in the investigator's opinion, affect ocular physiology or lens performance.
tolterodine drug use investigation.(post marketing commitment plan)

Conditions: Overactive Bladder

Summary: the objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the package insert (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

all the subjects whom an investigator prescribes the first detrusitol capsule should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: * male or female subjects intend to treat their overactive bladder who are prescribed detrusitol capsule by their physicians. exclusion criteria: * subjects who have been prescribed detrusitol capsule before.

Keywords: overactive bladder japanese tolterodine detrusitol detrol postmarketing commitment plan.