Kornimate/medical-research-clean huggingface dataset:
different premedication in pediatric patients

Conditions: Agitation

Summary: the investigators studied the effects of intranasal dexmedetomidine compared with oral midazolam with different doses for premedication in children. one hundred and twenty children aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal dexmedetomidine group ; 0.5mg/kg oral midazolam group;0.05 mg/kg intravenous injection midazolam group; no premedication group. sedation levels 10, 20, and 30min after premedication were evaluated using a 5-point sedation scale. a 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. agitation scores (pediatric anesthe-sia emergence delirium \[paed\] scale) and pov were assessed in the postanesthetic care unit (pacu).times to endotracheal tube or laryngeal mask airway removal, discharge from the pacu and patients' satisfaction degree were also assessed.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * a recent history of upper respiratory tract infection, a known allergy to dexmedetomidine or midazolam, inability to understand the consent process or parental refusal.
optimization of vonoprazan-based dual therapy for helicobacter pylori

Conditions: Helicobacter Pylori Infection

Summary: the purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for helicobacter pylori.

this study intends to select the patients with hp infection in 13 tertiary hospitals across our country, and randomly give the three therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with h.pylori infection. before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.the experimental data will be collected and recorded through follow-up by phone or wechat during the experiment.

Eligibility criteria:
inclusion criteria: 1. ages between 18 and 70 years; sexes eligible for study: both; 2. patients who are diagnosed with helicobacter pylori with 13c urea breath test or 14c urea breath test; 3. treatment-naive patients or patients who failed to eradicate helicobacter pylori in the past but haven't undergone eradication therapy in the past six months; 4. voluntary to be involved in the study and written informed consent was obtained from all patients exclusion criteria: 1. allergic reactions to the study drugs; 2. patients with peptic ulcer; 3. patients who underwent eradication therapy for helicobacter pylori during the last six months; 4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took h2 receptor antagonists,proton pump inhibitors(ppis) or potassium competitive acid blockers within two weeks prior to treatment; 5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants; 6. patients who have history of esophageal or gastric surgery; 7. pregnant or lactating women; 8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies; 9. alcohol abusers 10. malt lymphoma of stomach or malignant tumor

Keywords: helicobacter pylori dual therapy eradication rate safety microbiota
study of amg0001 to improve ulcer healing and perfusion in subjects with peripheral ischemic ulcers

Conditions: Peripheral Artery Disease; Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease; Chronic Limb Threatening Ischemia; Ischemic Ulcer of Foot

Summary: this study will assess the safety and efficacy of intramuscular injection of amg0001 (hepatocyte growth factor \[hgf\] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.

this is a phase 2, double-blind, randomized, placebo-controlled, parallel group study. approximately 60 male or female subjects aged 18 years or older with one shallow foot ulcer and mild/moderate ischemia due to peripheral artery disease (pad) will be randomized in a 1:1:1 ratio to one of 3 treatment groups: * 4.0 mg amg0001 intramuscular (im) (n = 20) * 8.0 mg amg0001 im (n = 20) * placebo im (n = 20)

Eligibility criteria:
inclusion criteria: * documented diagnosis of pad and mild/moderate foot ischemia (wifi ischemia grades 1, 2) * a single measurable ulcer of ≥ 1 cm2 and ≤ 10 cm2 on a lower extremity without evidence of infection or gangrene and no evidence of bone and/or tendon involvement at randomization * subjects will undergo protocol-defined standardized wound care during the screening period and through 12 months from the first dose of investigational product * subjects who have a diagnosis of diabetes must be considered stable with no changes in diabetic medication regimen anticipated during the study period. subjects who have a diagnosis of diabetes must have a hba1c of ≤12% at screening exclusion criteria: * subjects who have excessive tissue necrosis that is unlikely to benefit from medication, or those subjects who, in the opinion of the investigator, are felt likely to require revascularization within 1 month of screening * subjects with severe limb ischemia * subjects who are considered likely to require a major amputation (at or above the ankle) within 3 months of screening * subjects with deep ulcerations with bone or tendon exposure, or uncontrolled infection, or with the largest ulcer that is \>10 cm2 in area * subjects with hemodynamically significant aorto-iliac occlusive disease * subjects who have had a technically successful revascularization by surgery or angioplasty within 2 months. if subjects are more than two months from revascularization and still meet the inclusion criteria, they may be considered for enrollment. subjects who have had a technically unsuccessful attempt at revascularization may be enrolled at least one week from the procedure * subjects currently receiving immunosuppressive medication, systematically administered steroid therapy, chemotherapy or radiation therapy. inhaled and topical steroid therapies are allowed
personalized treatment for eating disorders versus cbt-e trial

Conditions: Eating Disorders

Summary: the scientific premise, developed from past work, is that treatment personalized based on idiographic models (termed network informed personalized treatment; na-pt) will outperform the current gold-standard treatment (enhanced cognitive behavioral therapy: cbt-e). the study goals are to (1) develop and test the acceptability, feasibility, and preliminary efficacy of a randomization of na-pt versus cbt-e and (2) to test if network-identified precision targets are the mechanism of change. these goals will ultimately lead to the very first personalized treatment for ed and can be extended to additional psychiatric illnesses. specific aims are (1) to collect preliminary data on the feasibility and acceptability of the randomization of na-pt (n=40) for eds versus cbt-e (n=40), (2) to test the initial clinical efficacy of na-pt versus cbt-e on clinical outcomes (e.g., ed symptoms, body mass index, quality of life) and (3) to examine if changes in na-identified, precision targets, as well as in dynamic network structure, are associated with change in clinical outcomes.


Eligibility criteria:
inclusion criteria: * age 18-65 * meets criteria for dsm-5 defined an, bn, bed, or osfed (atypical an and atypical bn) * not currently receiving psychological treatment focused on ed exclusion criteria: * under 18 * over 65 * does not meet criteria for dsm-5 defined an, bn, bed, or osfed (atypical an and atypical bn) * high and active suicidality * active mania * medically compromised status including extremely low weight - less than or equal to 75% median bmi for age, sex, and height * simultaneous psychological treatment focused on ed

Keywords: eating disorder treatment anorexia nervosa bulimia nervosa binge eating disorder atypical anorexia nervosa therapy other specified feeding and eating disorder
a multiple dose study of the safety, tolerability and pk of cmx157 in healthy subjects

Conditions: Infectious Disease

Summary: this is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of cmx157 at increasing dose levels.

this is a phase 1 study to evaluate the safety and tolerability of multiple oral doses of cmx157 at increasing dose levels, in a fasted state and a fed state.

Eligibility criteria:
inclusion criteria: * age: 18-55. * capable of giving written informed consent. * capable of completing study requirements. exclusion criteria: * positive result for hiv, hbv, or hcv. * history or medical condition which could impact patient safety. * current or past abuse of alcohol or illicit drugs. * participation in another clinical trial within the past 30 days.
assessment of the embolization of neurovascular lesions using the penumbra smart coil

Conditions: Intracranial Aneurysm

Summary: the primary objective of this study is to gather post market data on the penumbra smart coil® system (smart system) in the treatment of intracranial aneurysms and other malformations.

this is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the smart system (smart), penumbra coil 400tm (pc 400), and penumbra occlusion device (pod®). data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up. approximately 1,000 patients with intracranial aneurysms or other malformations treated by the smart system at up to 100 centers will be enrolled. it is anticipated patient enrollment will take 3 years. all patients are to be assessed in accordance with the standard of care at each participating hospital through one year follow-up.

Eligibility criteria:
inclusion criteria: patients enrolled in this study must sign the informed consent form and be treated according to the cleared indications for the smart, pc 400, and pod, which include the embolization of: * intracranial aneurysms * other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae exclusion criteria: * life expectancy less than one year * smart, pc 400, or pod account for less than 75% of total number of coils implanted * participation in another clinical investigation that could confound the evaluation of the registry device

Keywords: penumbra smart coils pc 400 av malformations av fistulae pod
rescue stenting for failed endovascular thrombectomy in acute ischemic stroke (reset)

Conditions: Acute Ischemic Stroke; Intracranial Artery Occlusion

Summary: this study is a prospective, open-label, multi-center, registry study, designed to show that rescue stenting is safe and effective for emergency large vessel occlusion (elvo) patients who have mechanical thrombectomy failure. participants with elvo will initially underwent mechanical thrombectomy usig stent retriever, contact aspiration or both. after failure of mechanical thrombectomy, rescue stenting will be performed.


Eligibility criteria:
inclusion criteria: * 1. subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery m1 segment) * 2. age 19 or greater * 3. mrs before qualifying stroke, 0 or 1 * 4. baseline nihss score 4 or more * 5. ct aspects \> 6 or mr aspects \> 5 * 6. good collateral statues on ct angiogram (collateral grade by calgary group, 4 or 5) or corresponding to defuse 3 or dawn trial on perfusion imaging. * 7. onset (last-seen-well) time to femoral puncture time \< 24 hours * 8. failure of mechanical thrombectomy with stent retriever, contact aspiration or both * 9. subjects who received rescue stenting after failure of mechanical thrombectomy * 10. anticipated life expectancy of at least 12 months * 11. signed informed consent for study enrollment exclusion criteria: * 1. any contraindication to antiplatelet medication * 2. multiple simultaneous large vessel occlusions * 3. pregnancy * 4. severe contrast allergy or absolute contraindication to iodinated contrast agent * 5. patient has a severe or fatal combined illness that will prevent improvement of follow-up or will render the procedure unlikely to benefit the patient.
mindfulness and cognition in schizophrenia

Conditions: Schizophrenia

Summary: mindfulness (innovative and integrative practice in care) allows the individual to adapt his/her behavior (physical and emotional), in a stressful environment, by regulating cardiac activity, especially the parasympathetic system. in schizophrenia, despite the positive effect of treatments on symptoms (delusions and hallucinations), patients have altered markers of the parasympathetic (high frequency, hf) system. the investigator propose a session of mindfulness based stress reduction (mbsr) for patients suffering from schizophrenia in order to measure the impact on the parasympathetic system (hf), self-awareness (being well in one's body and being aware of their own actions; ease) and cognition (attention) in relation to the management of conflicts or emotions. the study compare with patients who receive a session of techniques based on the management of emotions and social cognition (cinemotion, michael's game and tom remed).


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of schizophrenia (men only) * aged 18-55 * with no change in antipsychotic medication and clinical status within four weeks prior to the study * affiliates or entitled to a social security scheme * who have given their informed consent before participating in the study. exclusion criteria: * history of head trauma, neurological disease or not stabilized serious physical illness * disorders related to the use of a psychoactive substance, as defined by the dsm-iv (abuse, dependence or withdrawal) within 6 months * beta blocking and anti-arrhythmic medications.

Keywords: schizophrenia mindfulness parasympathetic system
evaluation of espair, an educational therapy's program of patients with renal insufficiency before kidney transplant

Conditions: Renal Insufficiency

Summary: treatment care of end-stage renal insufficiency is an important public health issue. the balance between patients waiting for a kidney transplant and available graft raises questions. because of the non-adherence, risk of graft loss is increased to 7 times so in this trial patients will experiment an educational therapy's program as soon as they register on the transplant list.


Eligibility criteria:
inclusion criteria: * patient with renal insufficiency on dialysis or not * registered on transplant list exclusion criteria: * patient with psychological disorder * transplantation from living donor * patients with renal transplant antecedent

Keywords: renal insufficiency kidney transplant educational therapy
drug eluting balloon (deb) and long lesions of superficial femoral artery (sfa) ischemic vascular disease

Conditions: Peripheral Artery Disease

Summary: the primary purpose of this study is to assess safety and efficacy of the drug eluting balloon (deb) technology for the treatment of the superficial femoral artery (sfa) ischemic obstructive vascular disease in patients presenting with long lesions. as secondary aim this study is going to explore treatment effect on a number of procedural and clinical endpoints in order to collect information to design a future comparative effectiveness study.

the study is aimed at collecting preliminary safety and efficacy data related to the use of drug eluting balloon (deb) technology for the treatment of symptomatic superficial femoral artery (sfa) ischemic vascular disease in patients presenting with long lesions. the present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (ce marked) deb currently available on the market.

Eligibility criteria:
inclusion criteria: * documented ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to rutherford category 2, 3 or 4; * target lesion consists of a single solitary or multiple adjacent de novo or restenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm; * target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee); * life expectancy \>1 year in the investigator's opinion; * written informed consent. exclusion criteria: given the observational nature of the study, no study-specific but only clinical exclusion criteria will apply: * patient unwilling or unlikely to comply with fu schedule; * administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure; * known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel; * additional planned cardiac or peripheral percutaneous or surgical intervention including cabg within 30 days following the study procedure; * 15 cm long inflow lesion (≥50% ds) or occlusion (any length) in the ipsilateral iliac artery; * failure to successfully treat \< 15 cm long inflow lesion in the ipsilateral iliac artery

Keywords: drug eluting balloon (deb) technology long sfa lesions disease
effect of vitamin d in diets of preterm infants

Conditions: Premature Infants

Summary: transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation at birth. however, few data are available related to follow-up of infants receiving these formulas who were 28-34 weeks gestation at birth. primary hypothesis: provision of supplemental vitamin d to a transitional formula will lead to higher serum 25-hydroxyvitamin d (25-ohd) levels and no infant with a serum 25-ohd less than 20 ng/ml when assessed at approximately 52 weeks post-menstrual age (pma).


Eligibility criteria:
inclusion criteria: * born at 28 0/7 to 34 6/7 weeks pma and 1000-2250 g birth weight. * currently 34 0/7 to 38 6/7 weeks post-menstrual age at time of consent. * born at texas children's (including pavilion for women) or methodist campus hospitals or transferred within 48 hours of birth. * care expected to be provided at one of these institutions until discharge home. * any initial feeding will be permitted, but expected to transition to primarily (80% of feeds or up to 2 breast milk feeds per day) infant formula by 38 6/7 weeks pma or hospital discharge, whichever comes first. * able to tolerate 22 kcal/oz transitional formula and receive a volume of at least 130 ml/kg/day total feeding volume. * no longer receiving any form of mechanical ventilation or diuretics. low flow nasal cannula (\< ¼ lpm) will be permitted if it is anticipated this will be discontinued before hospital discharge. exclusion criteria: * bronchopulmonary dysplasia (bpd) requiring daily use of diuretics beyond 38 6/7 weeks pma (or hospital discharge, whichever comes first) and \> 22 kcal/oz concentration formula beyond 38 6/7 weeks pma. * major congenital anomalies, history of proven stage 2 or above nec, or severe feeding intolerance. * caloric density greater than 22 kcal/oz. * higher order multiples (however, twins are acceptable. twins will be randomized together. only data from 1 twin picked at random will be used in the final analyses.)

Keywords: vitamin d transitional formula
clinical trial for vespa amino acid mixture (vaam®)

Conditions: Sports Injury

Summary: atp is generated mainly through anaerobic metabolism during strenuous exercise, which is then followed by the generation of lactic acid. however, this process can only be maintained for a short time, approximately one minute, because the accumulation of lactic acid in the muscles may affect muscle performance. the efficiency of lactic acid metabolism is one of the most important reasons for endurance improvement. the purpose of this study was to evaluate the impacts of the daily ingestion of a commercially available vespa amino acid mixture (vaam®) beverage on blood parameters that are related to fatigue, muscle damage and immunity in healthy, young athletes during middle-distance running exercises. vaam® contains 17 types of amino acids at a certain ratio, and evaluations were completed during 10 weeks of consecutive required speed and strength running tests.

the subjects were instructed to maintain their usual dietary habits in addition to drinking vaam® (two cans every day) for 10 weeks. in detail, on the 6 days/week of supervised running tests, participants were instructed to consume one drink before their warm-up exercise and the other drink while running. during their sessions and without supervision (1 day/week), participants were also instructed to consume one drink in the morning after breakfast and the other drink in the evening after dinner. the subjects were divided into three groups for the running tests: 3 males were assigned to group 1, which involved training for the 1500-meter race; 2 males were assigned to group 2, which involved training for the 800-meter race; and 1 male and 3 females were assigned to group 3, which involved training for the 400-meter race. the running exercises began with a 45 min warm-up (including jogging, leg stretching, etc.) followed by running their specific races. the experimental procedure was conducted 6 days/week for 10 weeks.

Eligibility criteria:
inclusion criteria: * athletes from 16 to 18 years old; * subjects underwent a physical examination before enrollment and showed no sign of illness or malaise. exclusion criteria: * subjects were smokers or ergogenic aid users; * subjects had any metabolic, cardiovascular, renal, or liver diseases; * subjects had psychiatric disorders.

Keywords: vespa amino acid mixture (vaam®) young athletes nutrition lactic acid accumulation anaerobic metabolism atp sports damage