Kornimate/medical-research-clean huggingface dataset:
epidemiology of rotavirus infection in north india community

Conditions: Rotavirus Gastroenteritis

Summary: this study was designed to support site preparation and to conduct a disease burden study for the planning and implementation of the phase iii trials for the oral rotavirus vaccine 116e.

field workers conducted weekly surveillance in areas allocated to them and identified pregnant women, newborns and infants aged 9 to 12 months. children who were eligible for participation through criteria for inclusion and exclusion in the trial were enrolled. two cohorts were recruited, one cohort enrolled within one week of birth and followed up weekly till 1 year of age (cohort 1=100) and the second cohort enrolled at 12 months of age and followed up till 24 months of age (cohort 2=100). weekly contact were made by field workers for both the cohorts. at each contact cases of gastroenteritis were identified. all infants with gastroenteritis were assessed by a field worker/clinical coordinator. the child was assessed for presence of dehydration, danger signs. the field worker/clinical coordinator ensured that at least one diarrheal stool specimen was collected for each episode of gastroenteritis. infants were treated at the study clinic or escorted to one of the identified hospitals, if required. caregivers of the enrolled infants were explained the signs and symptoms of suspected intussusception, dehydration and danger signs that require hospital referral and were given the option to seek care from the study clinic or from one of the identified hospitals in the vicinity. stool specimens were collected in all diarrheal episodes. in a subset of 30 children who were identified early in a diarrheal episode and who shed rotavirus, multiple stool specimens were collected in order to assess duration of shedding of rotavirus during a natural infection. the study was also designed to collect information on data essential for planning and implementation of phase iii trials pertaining to trial logistics, data collection tools and validity of questions including those in the vesikari score.

Eligibility criteria:
inclusion criteria: * parents/guardian consent for participation and are able to understand study procedures * healthy infant aged ≤ 1 week - cohort i, children aged 12 months (+14 days)-cohort 2 * absence of any illness requiring hospitalization * no confirmed plans to move in the next 12 months exclusion criteria: * participating in any other trial * any signs or symptoms of active sepsis, pneumonia, meningitis or any other disease requiring hospitalization * known case of immunodeficiency disease, known hiv positive * known case of chronic gastrointestinal disease * any other conditions which in the judgment of the investigator warrant exclusion(e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)

Keywords: disease burden rotavirus gastroenteritis
intensive nutritional counseling in head-neck cancer patients undergoing radiotherapy

Conditions: Head-neck Cancer

Summary: in head-neck cancer patients undergoing radiotherapy (rt) malnutrition is associated with impaired quality of life, reduced survival, more frequent treatment interruptions and dose reductions. the international guidelines recommend early nutritional support in the presence of nutritional risk, as it allows preventing or treating malnutrition and improving the clinical outcomes, as well as the tolerability of oncologic treatments. previous nutritional intervention trials in head-neck cancer patients have been conducted on small samples and did not clarify the role of oral nutritional supplements (ons). accordingly, although current guidelines recommend as grade a the use of ons associated with dietary counseling for head-neck cancer patients undergoing rt, the efficacy of this nutritional intervention still needs to be evaluated in adequately sized and randomized clinical trials.


Eligibility criteria:
inclusion criteria: * newly diagnosed head-neck cancer * indication to radiotherapy * eastern cooperative oncology group performance status \<=2 * availability to planned measurements and to written informed consent. exclusion criteria: * age \<18 years * ongoing artificial nutrition * refusal
postmarketing surveillance study for quadrivalent influenza vaccine (vaxigriptetra®) in subjects aged 6 to 35 months

Conditions: Influenza

Summary: multi-center, observational, active safety surveillance study in participants aged 6 to 35 months in korea under routine clinical practices.

the planned duration of each participant's participation in the study will be 21 to 28 days.

Eligibility criteria:
inclusion criteria: * aged 6 to 35 months on the day of enrolment * informed consent form has been signed and dated by the parent or other legally acceptable representative * receipt of one dose of vaxigriptetra® on the day of inclusion in routine practice according to the approved local product insert exclusion criteria: - participation at the time of study enrolment (or in the 4 weeks preceding the enrolment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure
associated joint pain with controlled ankle movement (cam) walker boot wear

Conditions: Pain; Ankle Injuries

Summary: this study evaluates the location, frequency and duration of secondary site pain relating to immobilization in a cam walker boot.

patients wearing a cam walker boot for treatment of a foot or ankle injury were prospectively enrolled and evaluated for new or worsened secondary site pain. surveys at four time points were completed to evaluate the presence of secondary site pain, its severity, and its impact on overall function.

Eligibility criteria:
inclusion criteria: * all patients enrolled in the study must have an injury that requires wear of a cam walking boot for at least two weeks and have ambulation ad libitum without other aids (e.g crutches, canes, scooters, wheelchairs, etc.). exclusion criteria: * patients will be excluded from the study if they are a recent post-operative patient for lower extremity injury, have an additional acute injury to a lower extremity or back other than the foot or ankle injury being treated by the cam walking boot at the time of initiation of treatment, have an ongoing or history of lower extremity joint injury, arthritis, or back pain or have restricted weightbearing as instructed by a physician (i.e. for ankle fracture that cannot weightbear).
erlotinib 100mg or 150mg in treating egfr mutated nsclc

Conditions: NSCLC; EGFR Mutation

Summary: the purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in nsclc patients with egfr mutation in china.

in china it was confirmed that 150mg erlotinib was effective in nsclc patients wtih egfr mutation, but reducing dose occurring in some patients because of the drug related side-effects. thus, we sought to investigate that in chinese patients with egfr mutation whether low dose (100mg) erlotinib had similar efficacy but lower toxcities compared with standad dose (150mg) erlotinib.

Eligibility criteria:
inclusion criteria: 1. histological diagnosis of nsclc with phase iiib or iv disease; 2. sensitive mutation egfr gene (18, 19 del, 21 l858r gene mutation) (mutation detection methods:arms-pcr, sequence method) 3. never received anti-tumor therapies for the advanced stage; 4. never used egfr inhibitors; 5. measurable disease by recist criteria; 6. male or female patients \>=18 years of age; 7. ecog karnofsky performance 0\~3, life expectancy is greater than 12 weeks; 8. patients must be accessible for treatment and follow-up; exclusion criteria: 1. previously used egfr inhibitors 2. mix ingredients in patients with squamous cell carcinoma, small cell lung cancer; 3. allergic to erlotinib; 4. non-measurable lesions 5. pregnant or lactating women; 6. patients having other factors that preventing researchers from enrollment them.

Keywords: erlotinib egfr mutation
further cardiovascular outcomes research with pcsk9 inhibition in subjects with elevated risk

Conditions: Dyslipidemia

Summary: the primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.


Eligibility criteria:
inclusion criteria: * male or female ≥ 40 to ≤ 85 years of age * history of clinically evident cardiovascular disease at high risk for a recurrent event * fasting low-density lipoprotein cholesterol (ldl-c) ≥ 70 mg/dl (≥ 1.8 mmol/l) ) or non-high-density lipoprotein cholesterol (non-hdl-c) ≥ 100 mg/dl (\> 2.6 mmol/l) * fasting triglycerides ≤ 400 mg/dl (4.5 mmol/l) exclusion criteria: * new york heart association (nyha) class iii or iv, or last known left ventricular ejection fraction \< 30% * uncontrolled hypertension * uncontrolled or recurrent ventricular tachycardia * untreated hyperthyroidism or hypothyroidism * homozygous familial hypercholesterolemia * ldl or plasma apheresis

Keywords: high cholesterol treatment for high cholesterol lowering cholesterol lowering high cholesterol hypercholesterolemia
effects of cannabis abstinence on symptoms and cognition in depression

Conditions: Cannabis Use Disorder; Major Depressive Disorder; Cognition

Summary: the objective of this study is to assess the changes in symptoms and cognition that occur after a 28-day abstinence period in patients with comorbid cannabis use disorder (cud) and major depression (mdd). this study employs a 28-day abstinence paradigm a total of 8 visits to the camh russell site (screening, training, baseline, week 1, week 2, week 3, week 4, follow-up). participants should be between the ages of 18-55, meet criteria for moderate depression and cud, be non-treatment seeking, and be on a stable dose of antidepressant medication. the study visits will take up a total of approximately 22.5 hours with compensation for time provided. these visits will involve multiple clinical, substance use, and cognitive assessments. abstinence will be maintained by weekly behavioural coaching sessions and contingency reinforcement.


Eligibility criteria:
inclusion criteria: * ages 18-55 * meet dsm-5 diagnostic criteria for cannabis use disorder (cannabis use \>1 g/day, cudit score \>12) * meet dsm-5 diagnostic criteria for major depressive disorder as determined using the scid * be an outpatient receiving a stable dose of antidepressant medication(s) for at least 1 month * have a hamilton depression rating scale (hdrs-17) baseline total score greater than 14 * have a full scale iq greater than 80 as determined by the wtar * be a non-treatment seeking cannabis user * evidence of sufficient motivation and effort as measure by a test of memory malingering (tomm) score greater than 45 * urinary baseline thc-cooh levels greater than 150 ng/ml exclusion criteria: * meets criteria for abuse or dependence of alcohol or other illicit substances within the part 6 months (with the exception of cannabis, nicotine, or caffeine) * positive urine screen for illicit substances other than cannabis, nicotine or caffeine * current suicidal or homicidal ideation * psychotic disorder diagnosis (e.g. schizoaffective disorder, major depression with psychotic features) as determined by the scid * head injury with loss of consciousness greater than 2 minutes or requiring hospitalization * neurological or medical condition determined to effect cognition * be treatment seeking for cannabis use

Keywords: depression cognitive functioning cannabis use disorder
a phase 4 study investigating the efficacy of retaine™ in managing signs and symptoms associated with dry eye syndrome

Conditions: Keratoconjunctivitis Sicca

Summary: this study will evaluate the efficacy of retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent; * have a reported history of dry eye; * have a history of use or desire to use eye drops; exclusion criteria: * have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses during the study; * have previously had laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; * have used restasis® within 30 days of visit 1; * be a woman who is pregnant, nursing or planning a pregnancy; * be unwilling to submit a urine pregnancy test if of childbearing potential; * have a known allergy and/or sensitivity to the test article or its components; * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; * be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of visit 1.

Keywords: dry eye, dry eye syndrome, retaine, kcs, keratoconjunctivitis sicca
ocs-01: a phase 3 study evaluating the efficacy and safety of ocs-01 eyedrops compared to vehicle for the treatment of ocular inflammation and pain following cataract surgery

Conditions: Disorders of the Eye Following Cataract Surgery

Summary: the purpose of this study is to evaluate the efficacy and safety of ocs-01 ophthalmic suspension versus placebo (vehicle) in the treatment of inflammation and pain following cataract surgery.


Eligibility criteria:
inclusion criteria: * be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (pciol) implantation in the study eye; * have a pin-hole visual acuity (va) without any other correction \> 20 letters (approximately 20/400) in the operative eye and \> 35 letters (approximately 20/200) in the fellow eye as measured using an early treatment for diabetic retinopathy study (etdrs) chart at visit 1 (day -1 to day -28 \[prior to surgery\]). exclusion criteria: * have any intraocular inflammation (e.g. white blood cells or flare)present in either eye at the visit 1 (day -1 to day -28 \[prior to surgery\]) slit lamp examination; * have a score \> 0 on the ocular pain assessment at visit 1 (day -1 to day -28 \[prior to surgery\]) in the study eye.
different stapler cartridge for pancreatic stump texture to prevent pancreatic fistula

Conditions: Pancreatic Neoplasms; Pancreatic Fistula

Summary: the purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness.

distal pancreatectomy (dp) is the standard treatment for symptomatic benign, premalignant, and malignant lesions in the pancreatic body and tail.laparoscopic distal pancreatectomy (ldp) are reported to have lower blood loss, fewer postoperative complications and a shorter length of stay without a substantial increase in the operative time. pancreatic fistula (pf) is the major source of postoperative morbidity and is associated with numerous further complications, suffering, longer hospital stay, higher costs and sometimes death. frequencies range from 5% to 64%. several procedures have been proposed to reduce the rate of pf. stapler closure is considered to be safe and approved particularly in ldp. numerous predictive factors for pf have been reported in previous studies. among these risk factors, the most important might be the texture and thickness of the remnant pancreas. however, the judgment of pancreatic texture has been based on the surgeon's observation and there still exists no objective method of assessing pancreatic texture. furthermore there is no strict guideline on which type of cartridge to use according to pancreatic stump texture and thickness. therefore, this single blind randomized controlled trial is designed to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness. patients were stratified intraoperatively by gland texture-hard (fibrotic) or soft (normal) and subsequently randomized according to different stapler cartridge. pancreatic fibrosis is accessed by histopathology and pancreatic stellate cell.

Eligibility criteria:
inclusion criteria: 1. disease of pancreatic body and tail 2. age: 18 years or older 3. distant metastases are not diagnosed preoperatively. 4. patients who can provide written informed consent exclusion criteria: 1. patients with severe organ disease such as cardiac disease,respiratory illness 2. patients with pancreaticojejunostomy,pancreatogastrostomy 3. patients with conversion to laparotomy 4. patients with pregnancy
yoga therapy for adolescents with juvenile idiopathic arthritis

Conditions: Adolescent Juvenile Idiopathic Arthritis; Yoga Therapy

Summary: the purpose of the study is to better understand the effects of a yoga program on adolescents with juvenile idiopathic arthritis (jia). the investigators want to learn whether or not a yoga therapy based program will decrease pain and improve quality of life in patients with jia. this is an 8-week program with home program of online videos.

this is an 8-week program consisting of weekly yoga therapy classes in a public studio. the classes are led by a pediatric occupational therapist who is also a certified internationally accredited yoga therapist (c-iayt). the initial and final sessions will include an rheumatologist md evaluation including a physician global assessment and joint damage assessment (jadi) and visual assessment (vas). a visual analog pain scale will and peds quality of life questionnaire-arthritis module 4.0 will be administered. each yoga class is 75 minutes to include a set-sequence of postures including breathing exercises and final corpse pose (final relaxation).

Eligibility criteria:
inclusion criteria: * adolescents with formal diagnosis of jia, speak and understand english, can get on/off floor independently. exclusion criteria: * dependent on assistive device for ambulation; does not understand english, does not have a diagnosis of jia.

Keywords: yoga therapy jia quality of life pain management
dual-source computed tomography to improve prediction of response to cardiac resynchronization therapy

Conditions: Heart Failure - NYHA II - IV; Wide QRS Complex

Summary: cardiac resynchronization therapy (crt) is a widely accepted treatment that has led to improved clinical outcomes for patients with refractory congestive heart failure (chf), systolic dysfunction, and wide qrs duration. however, it requires implantation of an expensive device ($30,000) and about 1/3 of patients do not have clinical improvement. inadequate amounts of lv dyssynchrony or suboptimal lead placement may limit clinical response. dual-source computed tomography (dsct) allows for subtle detection during myocardial contraction for assessing lv dyssynchrony, and can also assess coronary venous anatomy and scar burden. thus dsct may be the ideal noninvasive modality to predict response to crt.


Eligibility criteria:
inclusion criteria: * older than 18 years of age * ability to provide informed consent * planned crt implantation * nyha functional class ii-iv heart failure * echo ejection fraction less than or equal to 35% * qrs duration greater than or equal to 120 ms * normal or mildly reduced kidney function (estimated serum creatinine less than or equal to 1.5 mg/dl or less than or equal to 1.3 mg/dl for diabetic subjects on metformin * for diabetic subjects on glucophage (metformin) they will be required to stop glucophage (metformin) for at least 48 hours after the administration of contrast. exclusion criteria: * known allergy to iodine or iodinated contrast * chronic persistent atrial fibrillation * pregnancy or unknown pregnancy status * subjects on glucophage (metformin) therapy that are unable or unwilling to discontinue therapy for 48 hours after ct scan * known inadequate venous access for appropriate iv caliber placement * iodinated contrast administration within the past 48 hours * subjects who cannot hold their breath for 10-15 seconds
tissue oxygenation are associated with anastomotic leak rates after an ivor lewis esophagectomy

Conditions: Esophageal Cancer

Summary: the purpose of this study is to test whether after an ivor lewis esophagectomy (the removal of a portion of the stomach and esophagus with re-attachment) there is an association between the intraoperative level of oxygen at the site where the esophagus is re-attached to the stomach (measured using the wipox), and the incidence of a disruption at the site of the attachment after the surgery.


Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo an open or a minimally invasive ivor lewis esophagectomy * \> or = to 21 years of age exclusion criteria: * patients who are not candidates for an esophagectomy as determined by the treating surgeon

Keywords: esophagectomy esophagus wipox instrument tissue oxygenation anastomotic leak 11-192
neuropeptides in the humane intra- og extracerebral circulation.

Conditions: Healthy; Migraine

Summary: the study aim at examining whether sumatriptan changes the plasma values of the neuropeptides vasoactive intestinal polypeptide (vip), calcitonin gene-related peptide (cgrp) and pituitary adenylate cyclase activating peptide (pacap) and the prostanoids 6-keto-pgf1α, and pge2, pgd2 og pgf2α.

the study is meant to give a better understanding of the basic mechanisms behind migraine, and a better understanding of the effects of sumatriptan on the trigemino vascular system. the endpoints are changes in the plasma values of the neuropeptides vasoactive intestinal polypeptide (vip), calcitonin gene-related peptide (cgrp) and pituitary adenylate cyclase activating peptide (pacap) and the prostanoids 6-keto-pgf1α, and pge2, pgd2 og pgf2α.

Eligibility criteria:
inclusion criteria: * healthy volunteers * 18-50 years, * 50-100 kg. * fertile women must use birth control. exclusion criteria: * all primary types of headache * daily intake of medicine except birth control * pregnancy * hypertension * hypotension * other chronic disease

Keywords: vip pacap cgrp prostanoids
pelvis displacement and gait indicators in patient with lumbar disc herniation

Conditions: Lumbar Disc Herniation; Gait Analysis; Pelvis Abnormal

Summary: the purpose of this study is to investigate the correlation between pattern of gait and pelvic displacement in patients with lumbar disc herniation.

walking is a repetitive movement that moves your body while keeping your posture stable. the pelvis is located between the hip and lumbar region, where many muscles are attached to regulate the movement of the hip and lumbar spine. asymmetrical pelvic alignment affects stability of the lower extremities and trunk, making normal walking difficult. the purpose of this study is to investigate the pattern of gait according to pelvic displacement in patients with lumbar disc herniation.

Eligibility criteria:
inclusion criteria: * lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of korean medicine through an mri * patient who got gait analysis exclusion criteria: * patients without mri and x-ray * patient diagnosed with ankle disease

Keywords: gait pelvic height leg length discrepancy sacral angle