Kornimate/medical-research-clean huggingface dataset:
an early phase 2 clinical study of ksp-0243

Conditions: Colitis, Ulcerative

Summary: a phase 2a, randomized, double-blind, placebo-controlled, multicenter, parallel-group study to administer ksp-0243 or a placebo once daily after breakfast for 8 weeks in 100 patients with mild to moderate active ulcerative colitis.


Eligibility criteria:
inclusion criteria: * patients aged 18 to 74 years old (both inclusive) * patients who have been given the diagnosis of ulcerative colitis for at least 12 weeks * patients with an endoscopic view typically seen with ulcerative colitis spreading \> 15 cm from the anal verge * patients with mild to moderate active ulcerative colitis who meet the certain conditions * patients who have an inadequate response to a fixed-dose oral 5-asa formulation (mesalazine or salazosulfapyridine) continued from at least 2 weeks prior to the start of the screening period exclusion criteria: * patients who underwent an enterectomy or are expected to require an enterectomy during the study period (except appendectomy) * patients who have or suspected to have bacterium- or parasite-induced infectious enteritis (e.g., infection with clostridium difficile) * patients with any of the following concomitant illnesses with the severity considered inappropriate as a study patient by the principal investigator or the subinvestigator or medical history thereof: * hepatic or renal disorders or cardiovascular, endocrine, metabolic, pulmonary, gastrointestinal, neurological, urological, genitourinary, and immune diseases,
a study of jnj-64304500 in participants with alopecia areata

Conditions: Alopecia Areata

Summary: the purpose of this study is to evaluate the clinical response of 22 weeks of study intervention with jnj-64304500, compared with placebo, in participants with moderate to severe alopecia areata (aa).


Eligibility criteria:
key inclusion criteria: * participant has a physician confirmed diagnosis of moderate to severe alopecia areata (aa) (greater than or equal to \[\>=\] 50 percent \[%\] scalp involvement) as measured using the severity of alopecia tool (salt) score; or participant has \>=95% loss of scalp hair for enrollment as alopecia totalis (at) or alopecia universalis (au) subtypes at the time of screening and baseline * current episode of hair loss is greater than (\>) 6 months (without evidence of spontaneous terminal hair regrowth within 6 months at the time of screening and baseline), but less than or equal to (\<=8) years * medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ecg) performed at either screening or week 0. any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator * medically stable on the basis of clinical laboratory tests performed at screening. if the results of the serum chemistry panel or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. this determination must be recorded in the participant's source documents and initialed by the investigator key exclusion criteria: * history of liver or renal insufficiency (estimated creatinine clearance below 60 milliliters per minute (ml/min)); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine (except stable thyroid diseases), neurologic, hematologic, rheumatologic, psychiatric disorders, or metabolic disturbances * currently has a malignancy or has a history of malignancy (with the exceptions of participants having adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ occurring more than 5 years prior to randomization) * known allergies, hypersensitivity, or intolerance to jnj-64304500 or its excipients * participants with current episode of hair loss for \>8 years * has previous treatment with an oral janus kinase (jak) inhibitor
bioequivalence study of saxagliptin and glucophage combination formulations in healthy subjects (a)

Conditions: Type 2 Diabetes Mellitus

Summary: to demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (ir) fixed dose combination (fdc) tablet to the 2.5 mg saxagliptin tablet and 500 mg metformin ir tablet co-administered to healthy subjects in a fasted and in a fed state.


Eligibility criteria:
inclusion criteria: * men and women ages 19 to 45 inclusive * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ecgs), and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m2, inclusive. bmi = weight (kg)/ \[height (m)\]2 exclusion criteria: * women of child-bearing potential (wocbp) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product * any significant acute or chronic medical illness * current or recent (within 3 months) gastrointestinal disease * any major surgery within 4 weeks of study drug administration * history of allergy to dipeptidyl peptidase 4 (dpp4) inhibitor or related compounds * history of allergy or intolerance to metformin or other similar acting agents * prior exposure to saxagliptin * prior exposure to metformin within 3 months of study drug administration. * estimated creatinine clearance (clcr) of \< 80ml/min using the cockcroft gault formula
celox™ pph for reaching haemostasis in patients with postpartum hemorrhage

Conditions: Postpartum Hemorrhage

Summary: this is a post market prospective, single arm clinical investigation to continuously assess the safety performance and effectiveness of the celox™ pph as a uterine haemostatic tamponade treatment for uterine postpartum hemorrhage (pph).


Eligibility criteria:
inclusion criteria: * subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation * female adult subjects (\>18 years of age). * diagnosis of pph with suspected uterine atony placental bed bleeding, placenta accreta or previa within 24 hours after vaginal delivery. * subjects with coagulation disorders can be included * minimal estimated blood loss (ebl), to be determined when investigator is ready to have the celox™ pph package opened. 500 ml of ebl for vaginal delivery or 1000 ml for caesarean section. * failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. note: uterotonic administration may continue concomitant with and post the celox™ pph use. * subjects with pph of cervical or vaginal origin. exclusion criteria: subjects who present with, uterine rupture or for any other conditions outside of atonic post-partum haemorrhage needing other interventional methods or surgery including uterine artery embolization (uae). * pregnancy or incomplete multiple pregnancy * unresolved uterine inversion. * current cervical cancer. * current purulent infection of the vagina, cervix, uterus. * planned c-section with closed cervix. * patients requiring trans-abdominal insertion of celox™ pph.
evaluation of a diabetes data management system

Conditions: Diabetes

Summary: the purpose of this study is to evaluate a diabetes data management program in the hands of potential users, both health care professionals and lay users.

diabetes data management programs analyze blood glucose results downloaded from glucose meters to assist health care professionals or lay users manage their diabetes. during the study, subjects download meters, generate and print reports, evaluate the program's ease of use, and verify that they understand the program output.

Eligibility criteria:
inclusion criteria: * health care professionals: 1. must have experience using diabetes data management software in the medical office such as downloading meters, reviewing reports (computer screen or printouts), or assisting in patients' diabetes disease management using software. 2. may include: endocrinologists, primary care physicians, nurse educators, or other medical staff involved in downloading meters or interpreting the data output. * lay users must: 1. be at least 18 years of age. 2. have diabetes (or be the parent or legal guardian of a child with diabetes) and have been testing blood sugar at home at least twice daily for one month or more. 3. be able to speak, read and understand english. 4. currently using diabetes management software at home or be familiar with diabetes management software. at least 75% of subjects must have been using software for at least one month. 5. have experience using pc programs or browsing the internet. exclusion criteria: * persons working for a competitive medical device company.
effects of l-theanine in boys with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study will examine the effects of l-theanine (an amino acid found in green tea) on the behavior, cognitive performance and sleep quality of boys with adhd.


Eligibility criteria:
inclusion criteria: diagnosis of attention deficit hyperactivity disorder (adhd) exclusion criteria: -

Keywords: adhd attention insomnia hyperactivity anxiety
a study of osi-7904l versus 5-fu/lv as treatment in patients with biliary tract cancer

Conditions: Locally Advanced or Metastatic Adenoca of the Biliary Tract

Summary: multi-center, randomized phase ii study to evaluate the efficacy and safety of osi-7904lversus 5 fu/lv in biliary tract cancer.


Eligibility criteria:
inclusion criteria: documented locally advanced or metastatic adenocarcinoma of the biliary tract; adequate bone marrow, hepatic and renal function; bilirubin \ = 20 mm (or \>= 10 mm on spiral ct-scan); ecog performance status 0-2; no prior chemotherapy for locally advanced or metastatic disease. adjuvant/neo-adjuvant permitted if therapy was completed at least 12 months prior to study entry; exclusion criteria: concurrent anticancer therapy while on study; history of other malignancy within the past 3 years except basal or squamous cell carcinoma or in situ cervical cancer; symptomatic brain metastases which are not stable or have required radiation in the past 28 days;
a study of artificial intelligence ecg with ecg devices to detect hypertrophic cardiomyopathy distinct from athlete's

Conditions: Hypertrophic Cardiomyopathy

Summary: the purpose of this study is to evaluate the ai-ecg algorithm for hcm in detecting hcm and in differentiating it from athlete's using not only the standard 12-lead ecg, but also ecgs obtained with the apple watch and alivecor kardiamobile devices.


Eligibility criteria:
inclusion criteria: * patients with clinically validated diagnoses of hcm (n=150) and athlete's (n=150) will be identified by pre-screening of the clinic appointments for each of the specialty hcm and sports cardiology clinics or in the cv fellows' clinic (in patients with an established diagnosis and no pending testing). all diagnoses will need to be supported by unequivocal imaging and other ancillary data per our standard of care and at the determination of clinic experts. exclusion criteria: * any exception to the above criteria.
preventing diabetic foot ulcers through cleaner feet

Conditions: Diabetic Foot Ulcer

Summary: foot complications are among the most serious and costly complications of diabetes. people with diabetes have a 10-fold increased risk for a leg or foot amputation compared to those that do not have diabetes. amputation of all or part of foot is usually preceded by a foot ulcer, which became infected. this is a clinical trial to test the effectiveness of a topical antiseptic, chlorhexidine, for daily foot cleaning on the occurrence of diabetic foot ulcers in veterans at high risk of a diabetic foot ulcer.

population: up to 200 veterans at high risk of a diabetic foot ulcer site: va maryland health care system (vamhcs) study duration: approximately 5 years study design: randomized double-blind clinical trial comparing a) a daily foot care regimen with cloths containing 2% chlorhexidine to b) a daily foot care regimen with cloths not containing 2% chlorhexidine objectives: primary: to determine if chlorhexidine reduces the occurrence of foot complications including chronic foot ulcer, foot infection or foot amputation. secondary: to determine if chlorhexidine increases antibiotic resistance among bacterial pathogens on feet. exploratory: to describe changes in the microbiota of the feet with chlorhexidine and foot complications treatment regimens: 2% chlorhexidine gluconate cloths versus bath cloths route of administration: topical application on the feet dose and interval: 1 cloth daily duration of participant's participation: up to 13 months

Eligibility criteria:
inclusion criteria: * adults \>=18 years * clinical diagnosis of diabetes * at high risk for a new diabetic foot ulcer due to: 1)past history of diabetic foot ulcer or 2)past history of major foot surgery including partial foot amputation or 3)past history of major foot infection or 4)neuropathy and onychomycosis and hemoglobin a1c \>8% or 5)neuropathy and peripheral vascular disease or 6)dialysis or 7)past history of charcot foot or 8)past history of peripheral vascular surgery or angiography with stent * two feet (can have amputation of part of the foot) * at least one foot without a foot ulcer * permanent mailing address suitable for provision of specimen collection materials and telephone suitable for monthly follow-up * able to give written informed consent exclusion criteria: * amputation of the foot planned to treat current foot ulcer or wound * current foot infection * use of topical chlorhexidine on feet 7 days prior to randomization * history of an allergic reaction to chlorhexidine * unable to use wipes for foot care * inability to walk * life expectancy less than 12 months * plans to move out of the area in the next 13 months * requires equivalent of institutional care (e.g. nursing home) * any other criteria which, in the investigator's opinion, would compromise the safety of the study, the ability of a subject to participate, or the results of the study

Keywords: topical chlorhexidine prevention clinical trial
short infusion versus prolonged infusion of ceftolozane-tazobactam among patients with ventilator associated-pneumonia

Conditions: Ventilator-associated Pneumonia

Summary: the main objective of this study is to compare the median exposures at pharmacokinetic equilibrium of the two modalities of administration: 4-hours infusion of ceftolozane-tazobactam at a dosage of 2 gram three times a day vs 1-hour infusion of 2 gram three times a day.

intensive care unit patients with ventilator associated-pneumonia often develop severe and rapidly life threatening gram-negative bacillus infections. moreover, they present pathophysiological disturbances responsible for major pharmacokinetic changes (volume of distribution and glomerular filtration) which may lead to drugs under-exposure. any delay in management or inadequate antibiotic therapy can have serious consequences in terms of prognosis. the association ceftolozane-tazobactam is an alternative to carbapenems in documented infections. ceftolozane is a new cephalosporin, marketed, in combination with tazobactam (beta-lactamase inhibitor) under the name zerbaxa®. zerbaxa® is active on gram-negative bacillus, including pseudomonas aeruginosa. this is a prospective, randomized, open pharmacokinetic/pharmacodynamic study that compares two modalities of administration of a novel antibiotic, zerbaxa® ceftolozane-tazobactam, by 4-hours infusion at the dosage of 2 gram three times a day vs. 1-hour infusion at the dosage of 2 g three times a day, among patients with ventilator associated-pneumonia to pseudomonas aeruginosa. the patient will be randomized either in the 4-hours or in the 1-hour infusion group. follow up visits are daily for any intensive care patient. those provided for biomedical research are carried out during the treatment period, at day 15 and day 28. for the pharmacokinetic study, 7 blood samples will be collected from 24 hours to 48 hours after the first zerbaxa® administration.

Eligibility criteria:
inclusion criteria * patients with ventilator associated-pneumonia to pseudomonas aeruginosa * patients hospitalized in intensive care units * pseudomonas aeruginosa susceptible to ceftolozane-tazobactam * simplified acute physiological score ii (saps ii () \> 20 * expected duration of survival \> 7 days * informed consent of the patient or, failing that, the patient's close or trustworthy person * affiliated to a social security scheme or equivalent non inclusion criteria: * history of allergy to one of the two molecules * history of allergy to betalactamines * strain isolated resistant to ceftolozane-tazobactam combination * renal insufficiency with a glomerular filtration rate evaluated by chronic kidney disease epidemiology collaboration (ckd-epi) \< 50 ml/min * patient on dialysis or under continuous hemodiafiltration * pregnant or nursing women * patient benefiting from a system of legal protection for adults * patient with active immunodepression.

Keywords: pneumonia pseudomonas aeruginosa pharmacokinetics
distraction technique to reduce discomfort of transnasal fiberoptic laryngoscopy

Conditions: Pain

Summary: to compare the effectiveness of reducing discomfort during flexible nasal endoscopy using simple distraction techniques compared to topical anaesthetic spray and a control group that does not receive topical anaesthetic spray or a distraction technique.

in this randomised controlled study patients will be randomly allocated into one of four groups; the first group will receive topical (co-phenylcaine) anaesthetic spray without distraction, the second group will receive topical (co-phenylcaine) anaesthetic spray with distraction, the thirds group will receive no topical (co-phenylcaine) anaesthetic spray without distraction and the fourth group will receive no topical (co-phenylcaine) anaesthetic spray with distraction. the distraction technique that will be employed is counting backwards from 30 to 1 in even numbers only. all flexible nasal endoscopies will be performed by either of the two most senior clinicians involved in the study. the procedure will be carried out in standard outpatient clinic room setting. post procedural discomfort assessments will be undertaken using a visual analogue scale (vas). power calculations shows that \>24 patients would result in an adequately powered study (\>80%). data analysis will be undertaken by spss and independent t-tests will be performed to assess for statistical significance.

Eligibility criteria:
inclusion criteria: * male and female participants aged 18+ * patient requires flexible fiberoptic transnasal laryngoscopy. * patient has no preferences in relation to which arm of the study they would like to be in. exclusion criteria: * flexible nasal endoscopy not indicated * local anaesthetic required for other reasons - e.g. vasoconstrictor effects * patient has a clear preference to which group they are randomised to * significant sino-nasal disease * patient under the age of 18

Keywords: pain during laryngoscopy, flexible nasal endoscopy
effect of rhythmic auditory stimulation on balance in children with cerebral palsy.

Conditions: Cerebral Palsy

Summary: to evaluate the effect of rhythmic auditory stimulation (ras) on balance in children with cerebral palsy.


Eligibility criteria:
inclusion criteria: * patients with cerebral palsy at 7-15 years old with gross motor function classification system 1-3. * patients can understand and follow to command. exclusion criteria: * patients who received surgery/chemo-denervation injection/injury at spine/pelvic/lower extremities in last 6 months. * patients with intrathecal baclofen pump implantation. * patients with other signs and/or symptoms of neurological deficit that effect ability to ambulation.

Keywords: cerebral palsy, rhythmic auditory stimulation, balance
strabismus measurements using automated 3d video oculography

Conditions: Strabismus

Summary: measuring ocular motility and alignment is important for diagnosing different causes of strabismus, following patients recovering from cranial nerve palsies, preparing patients for strabismus surgery and follow-up post surgery. the current clinical gold standards for measuring ocular alignment are the hess screen and the harms tangent screen. these tests are accurate, but require patient cooperation, and are not objective because the patient has to indicate the position of the light he sees on the screen. our objective is to develop an accurate and easy to use goggles system to measure ocular alignment and motility using 3d video oculography.


Eligibility criteria:
inclusion criteria: * patients 11 years or older * congenital strabismus * acquired strabismus * paretic strabismus (oculomotor, abducens and trochlear nerves) * before and after strabismus surgery * normal controls exclusion criteria: * patients unable to sign informed consent * patients with significantly impaired vision * patients unable to cooperate with standard strabismus workup (including hess and harms tests) * for sub-study: intolerance to scleral search coils

Keywords: strabismus oculomotor palsy abducens palsy trochlear palsy
home-based -virtual reality intervention for stroke rehabilitation

Conditions: Stroke

Summary: on-going rehabilitation is needed to maintain and improve the weaker upper extremity following stroke. community rehabilitation programs for stroke individuals in the chronic stage are often difficult to be implement. consequently, many individuals remain without structured interventional programs. self-training programs, where individuals can independently continue to exercise at home, might answer this challenge. however, since exercising alone is boring and not motivating, individuals often stop the prescribed exercises and remain inactive. the use of video-games for self-training might answer this challenge. therefore, the investigators aimed to assess the feasibility of using video-games for self-training after stroke. specifically the investigators aim to compare the (1) training time, (2) satisfaction and (3) effectiveness of a self-training program using video-games compared to a traditional self-training program.

this is a single-blind randomized controlled trial with four assessments; two before and two following the 5-week self training intervention. individuals are requested to perform the self training (video-games or traditional exercises) 60 minutes a day for 5 weeks.

Eligibility criteria:
inclusion criteria: * 6 to 36 months after stroke onset * lived in the community with family or a caregiver * mild to moderate weakness the affected upper extremity * without significant cognitive deficit * able to walk at least 10-meters (with or without assistance). exclusion criteria: * other neurological conditions * epilepsy