Kornimate/medical-research-clean huggingface dataset:
an observational, prospective, multicenter study to evaluate the biologic use and outcomes in chinese asthma patients

Conditions: Asthma

Summary: this study is a multicenter, observational, prospective study to evaluate the asthma biologic use features and clinical outcomes in china. patients will undergo clinical assessments and receive standard medical care as determined by the treating physician.

this study is a multicenter, observational, prospective study to evaluate the asthma biologic use features and clinical outcomes in china. patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. approximately 200 patients with a physician diagnosis of asthma and prescribed with asthma biologics at visit 1 will be enrolled in this study, distributed among 50 sites across different regions in china. during the study period, patients will be identified consecutively and, if they meet eligibility criteria and provide informed consent will be entered into this observational study. patients should have an asthma diagnosis and be prescribed at least once with biologics for asthma treatment at enrollment (visit 1, week 0). after the enrollment, subjects will be followed up at visit 2(week 24) and visit 3 (week 52). v1, v2 and v3 will be followed up by on-site visit. at visit 1, data within last 12 months will be retrospectively collected as baseline. patients existing medical record (mr) data will be collected in week 24 and week 52. pros (asthma control test \[act\], asthma quality of life questionnaire (+12) \[aqlq(s)+12\]) should be performed at visit 1, visit 2 and visit 3. no additional mandated interventions on top of routinely performed physician visits, examinations or treatments will be required. patients will not receive any experimental disease management intervention or experimental treatment as a result of their participation in the study.

Eligibility criteria:
inclusion criteria: 1. chinese, female or male 2. age: no limitation 3. physician-confirmed asthma diagnosis with documented evidence of diagnosis or evidence of variable expiratory airflow limitation (e.g., from bronchodilator reversibility testing or other tests). 4. participants or their legal guardians must be able to provide informed consent. 5. prescription of asthma biologics at enrolment. exclusion criteria: 6. participation in an interventional study within the last 3 months. 7. any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study with the usage of biologics, or may influence the results of the study, or the patient's ability to participate in the study
donafenib and toripalimab combined with tace in patients with unresectable hepatocellular carcinoma

Conditions: Unresectable Hepatocellular Carcinoma

Summary: this study is the single-center, open-label phase i clinical trial to evaluate tolerability, safety and efficacy of donafenib and js001 in combination with tcae in patients with unresectable hepatocellular carcinoma.

the phase i clinical trial is to determine the maximum tolerated dose (mtd) and dose limiting toxicity (dlt) of donafenib in this regimen, and select an acceptable safe dose for the phase ii clinical trial(rp2d).

Eligibility criteria:
inclusion criteria: * age 18-75 (inclusive), male or female; * diagnosis of unresectable hepatocellular carcinoma confirmed clinically or histologically or cytologically according to the "guidelines for diagnosis and treatment of primary liver cancer" (2019 edition); * at least one measurable lesion (according to recist v1.1) * ecog performance status score of 0 -1; * life expectancy ≥ 12 weeks; * fully understand this research and voluntarily sign the icf. exclusion criteria: * diffuse liver cancer； * refractory hepatic encephalopathy, refractory ascites, or hepatorenal syndrome； * pregnancy or lactation； * patients with extrahepatic diffusion； * spontaneous tumor rupture； * expected non-compliance.
significance of platelet indices and ratios in different degrees of burn

Conditions: Platelet Indices; Platelet Ratios

Summary: study the correlation between the platelet indices and different degrees of burn study the correlation between the platelet ratios and different degrees of burn.

burns are a major traumatic pathology characterized by tissue destruction and cellular degradation resulted by energy transfer and mainly affect skin, which serve as significant cause of morbidity and mortality. burns are classified as first,second and third degree depending on how deep and severe they penetrate the skin surface. platelets play important role in primary homeostasis, thrombosis, inflammation and tissue regulation in the processes of wound healing. platelets can contact exposed collagen and extra cellular matrix and releasing clotting factors to achieve homeostasis as well as essential growth factors and cytokines to repair the wound.in clinical, platelet-rich plasma (prp) is a concentrate of autologous platelets,has been used to effectively accelerate burn wound healing platelet indices (pi), markers of platelet activation, are parameters obtained daily as a part of an automatic blood count, platelet indices are related to platelets morphology and proliferation kinetics. most commonly assessed platelet indices include the mean platelet volume (mpv), mean distribution width(pdw),platelet larger cell ratio (plcr) ,platelet crit (pct), mean platelet mass (mpm),mean platelet component (mpc),platelet component distribution width (pcdw) and immature platelet fraction (ipf). the ratio of red blood cell distribution width (rwd) and platelet (plt) (rpr) is considered an inflammation biomarker associated with the poor prognosis of number of diseases. there is two studies about prp related to prognosis of major burn injury . results indicate that rpr-as an inflammatory index- can be used as a biomarker for prognosis of adult patients with major burn injuries. blood-based platelet parameters, due to their fairly easy accessibility and inexpensive methods of measurement, seem to be on the rise as potential novel biomarkers of numerous ,both acute and chronic disease. however, to date ,there are no data on the significance of platelets indices in evaluation with different degrees of burn .in this study we will evaluate the significance of platelet ratios and indices in different degrees of burn.

Eligibility criteria:
inclusion criteria: * burn degree ( 1,2,3) exclusion criteria: * patient with itb
sample collection to evaluate an investigational instrument for the detection of respiratory viruses in nasopharyngeal swabs

Conditions: Viral Respiratory Infection

Summary: the purpose of this sample collection study is to prospectively collect respiratory viral clinical samples, conduct standard of care comparator testing and archive the collected residual samples for future testing in order to establish the clinical performance characteristics of the investigational instrument.


Eligibility criteria:
inclusion criteria: * the specimen is a nasopharyngeal swab. * the specimen is from a pediatric or adult male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long term care facility. * the specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis, and pneumonia. exclusion criteria: * the specimen is not a nasopharyngeal swab. * the specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.

Keywords: respiratory virus
point of care device use in the pediatric emergency department

Conditions: Dehydration; Seizure; Gastroenteritis; Hyperglycemia

Summary: to compare the effect of "point-of-care" (poc) analysis of blood work with traditional laboratory methods on length of stay in a pediatric emergency department (ped).

this study was a prospective, randomized controlled study of patients requiring blood work that a poc device was capable of performing. length of time spent at various timepoints were prospectively recorded by a dedicated research assistant after randomization.

Eligibility criteria:
inclusion criteria: * clinically requiring bloodwork capable by the poc device exclusion criteria: * requiring other bloodwork such as medication levels, wbc

Keywords: point-of-care testing pediatric emergency department length of stay efficiency
a phase iv study of safety and efficacy of everolimus in taiwanese patients with tuberous sclerosis complex who have renal angiomyolipoma (tsc-aml)

Conditions: Renal Angiomyolipoma

Summary: the purpose of this prospective study is to assess the safety and efficacy of everolimus in taiwanese patients with renal angiomyolipoma (aml) associated with tuberous sclerosis complex (tsc) . only patients who fulfil the local reimbursement criteria of everolimus for tsc-aml will be included in this study.

this open-label, prospective, single-arm, multicenter phase iv post approval commitment (pac) study is planned to be conducted in approximately 10 patients with confirmed diagnosis of tsc-aml and who fulfil the local reimbursement criteria of everolimus for tsc-aml treatment. the study will have a 30-day screening phase, and each patient will be on treatment up to 52 weeks. enrollment will end at the latest within 52 weeks from day 1 of the study, regardless of the number of patients actually recruited. after completion of the treatment phase/end of treatment (eot), eligible patients will enter a 4-week safety follow up (fu) phase. patients who continue to be on treatment beyond 52 weeks, based on the investigator's judgment will not be included in the 4-week safety fu phase.

Eligibility criteria:
inclusion criteria: 1. adult male or female patients from ≥ 18 years of age. 2. signed informed consent must be obtained prior to participation in the study. 3. participants with tsc associated with renal aml which is eligible for treatment with everolimus per local reimbursement criteria. exclusion criteria: 1. patients with severe hepatic impairment (child-pugh class c) 2. any severe and/or uncontrolled medical conditions. 3. pregnant or breast-feeding females. 4. patients with hypersensitivity to the active substance, to other rapamycin derivatives, or to any of the excipients.

Keywords: tuberous sclerosis complex tsc angiomyolipoma aml everolimus
extended-release of octreotide (lf-pb) for the treatment of lymphorrhea

Conditions: Lymphorrhea

Summary: this is a phase ii, multicenter, double-blind, double-dummy, parallel-group, placebo-controlled, study to evaluate lf-pb versus placebo in female patients with brest cancer who are undergoing breast surgery with axillary lymphnode dissection. recruited patients will be randomly assigned to one of the following treatment groups: placebo, lf-pb 10 mg, lf-pb 20 mg and lf-pb 30 mg. mode of administration is single intramuscular (im) injection so the treatments arms are as follows: placebo: 2 injections of placebo lf-pb 10 mg: 2 injections = placebo + 10 mg lf-pb 20 mg: 2 injections = placebo + 20 mg lf-pb 30 mg: 2 injections = 10 mg + 20 mg the study will randomize a total of 120 patients (30 per arm) in about 10 italian sites.


Eligibility criteria:
inclusion criteria: 1. female aged 18 to 80 years inclusive 2. body mass index (bmi) ≥18 kg/m2 3. signed informed consent form 4. diagnosis of bc 5. undergoing breast surgery with alnd note: collagen powder or fibrin sealant are not permitted. 6. negative serum pregnancy test for women of childbearing potential note: female patients of child-bearing potential should be advised to use adequate contraception if necessary during treatment with octreotide. 7. ast and alanine aminotransferase alt \<1.5 x the upper limit of normal 8. ability to fully understand all study procedures and to comply with study visits scheduled for the duration of the study. exclusion criteria: 1. presence of any of the following conditions: 1. previous axillary surgery on the same armpit undergoing surgery in this study 2. previous chemotherapy or radiotherapy within five years from study drug administration 3. previous neoadjuvant therapy 4. recurrent bc on the same breast undergoing surgery in this study 5. diabetes 6. cholelithiasis 7. hypothyroidism. if patient is being administered euritox/ levothyroxine (or analogues) and levels of t3, t4 and tsh are confirmed to be within the normal ranges at screening, the patient can be enrolled in this study. 8. hepatitis 9. pregnant or lactating 10. human immunodeficiency virus or hepatitis b or c by screening serology 2. history of radiotherapy on the same breast or armpit undergoing surgery in this study. 3. history of anaphylaxis to study drug 4. ascertained or presumptive hypersensitivity to the active principle and/or the ingredients of the study drug formulation 5. qtc interval extension at screening or baseline \> 450 msec (as the mean of 3 consecutive readings 5 minutes apart) 6. presence of any disease or use of concomitant medication known to increase the qt interval (see appendix 2 for a list of such compounds) 7. clinically significant or relevant abnormal medical history, vital sign, physical examination, ecg, or laboratory evaluation finding 8. current or recurrent disease that could affect the results of the clinical or laboratory assessments required for the study
chronic-dose safety and efficacy study of albuterol-hfa-bai in pediatric asthmatics

Conditions: Asthma

Summary: this study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. the dosing period lasts three weeks and starts following a three-week run-in period.


Eligibility criteria:
inclusion criteria: * persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening * male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (fev1) 60-90% * ability to perform spirometry * demonstrate 12% airways reversibility exclusion criteria: * require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids * presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases

Keywords: asthma pediatric asthma
mobile integrated care for childhood obesity

Conditions: Obesity

Summary: the goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight. families who participate will be assigned by chance to one of two groups. one group will see their child's primary care provider to talk about healthy lifestyles for 6 months. the other group will be in our healthy lifestyle program for 6 months. this will include: * check-ins with lifestyle specialists and community health workers, * a mobile app to help support a healthy lifestyle, and * access to community programs and activities. the main questions the study aims to answer are: * do children in the healthy lifestyle program have better weight outcomes? * do more families in the healthy lifestyle program stay in the study? * does the healthy lifestyle program work better for families from certain communities?


Eligibility criteria:
caregiver and child dyads will be enrolled inclusion criteria: * child 4-12 years of age * child is a patient of the nemours children's health primary care clinics in milford, seaford, and millsboro * child has a bmi ≥ 95% for age and sex * child is from a clinic serving rural neighborhoods (ruca ≥ 4) exclusion criteria: * caregiver not child's legal guardian * caregiver not proficient in english or spanish * caregiver does not have a device and reliable internet * child has a genetic syndrome or endocrine disorder that predisposes to obesity * child is on a medication that impacts weight * child is already enrolled in a weight management program

Keywords: disparities stakeholder engagement social determinants of health healthcare delivery
multimodal imaging in central serous chorioretinopathy

Conditions: Central Serous Chorioretinopathy

Summary: this study aims to assess the contribution of the multimodal imaging, combining a routine examination using optical coherence tomography (oct) with an imaging procedure using adaptive optics retinal camera. this is a feasibility study with a limited number of patients.


Eligibility criteria:
inclusion criteria: * signed informed consent form * beneficiary/affiliated to french social security/social healthcare * active ou chronic central serous chorioretinopathy on at least one eye * absence of other known ophthalmological pathology or of any ophthalmological conditions revealed during the examination exclusion criteria: * legal incapacity or limited legal capacity * predictable poor adherence * subject without health insurance * pregnant or breatfeeding women * sujet étant dans la période d'exclusion d'une autre étude ou prévue par le "fichier national des volontaires" * presence of transparent medium opacity damaging images quality * previous photosensitivity * recent treatment with photodynamic therapy (pdt) * use of drugs inducing photosensitivity

Keywords: optical coherence tomography retinal camera
multi-center study of shuntcheck

Conditions: Blocked Ventricular Shunts

Summary: multi-center study of shuntcheck


Eligibility criteria:
inclusion criteria: exclusion criteria:

Keywords: hydrocephalus high pressure shunt blockage
effectiveness and safety of the dexcom™ g4 continuous glucose monitoring system in pediatric subjects with diabetes mellitus

Conditions: Pediatric Subjects With Diabetes Mellitus

Summary: the primary objective of the study is to evaluate the safety and effectiveness of the g4 system (system) when used as an adjuvant to blood glucose testing over a 7-day period in pediatric subjects with diabetes mellitus. system effectiveness will be primarily evaluated with comparison to laboratory reference yellow springs instrument (ysi) venous sample measurements. the system performance will be evaluated in terms of point and rate accuracy of the system in reference to ysi. the point accuracy is measured as the proportion of g4 system values that are within ±20% of ysi reference value for glucose levels \>80 mg/dl and ±20 mg/dl at ysi glucose levels \<80 mg/dl. the trend accuracy of the device performance, i.e., continuous glucose error grid analysis, will be evaluated as well as the temporal accuracy at different glucose rates of changes and different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). the primary matched paired (sensor-ysi) measurements will be collected during one in-clinic session. system effectiveness will also be evaluated with smbg measurements similarly. safety data of the system will also be collected and safety will be characterized by the incidence of adverse device effects (ade) experienced by study participants. other objectives include the evaluation of device performance at an alternate site (the upper buttocks).


Eligibility criteria:
inclusion criteria: * ages 2 to 17 years ; * diagnosis of diabetes mellitus; * willing to participate in one 7-day sensor wear period; * willing to wear 2 systems simultaneously; * willing to take a minimum of 7 fingersticks per day during home use with a blood glucose meter provided; * willing to attend one in-clinic session of up to 6 hours duration. clinic procedures where blood sampling via smbg and/or venous ysi method, depending on age; * subject or guardian is able to speak, read, and write english. exclusion criteria: * extensive skin changes/diseases at sensor wear site that preclude wearing the sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis); * known allergy to medical-grade adhesives; * require a magnetic resonance imaging (mri) scan, computed tomography (ct) scan, or diathermy during the wear period. if any of these procedures are required urgently during the study, subjects will notify the study staff, end their continuous glucose monitoring (cgm) session, and remove their sensor.

Keywords: pediatric diabetes mellitus
study of myocardial contractility after cardiac surgery under an anterograde or retrograde cardioplegia

Conditions: Heart Arrest

Summary: myocardial protection is a fundamental element for the safety of patients when performing cardiac surgery. for this purpose, cardioplegia were rapidly established in clinical practice to protect the myocardium when performing aortic clamp. cardioplegia are procedures to stop the contraction of myocardium. it is usually achieved with the use of chemicals ( cardioplegic solutions) or cold temperature (such as chilled perfusate). the composition of the cardioplegic solutions and their method of administration continuously changed over the years. at the present date, cold blood cardioplegias are performed in the investigator's center. the investigators regularly use two modes of administration: either by an antegrade path (injection in the coronary arteries), or a retrograde one (injection in the venous system). at present, there are no elements supporting the superiority or inferiority of one path compared to another. the difficulty lies within a clear estimation of the contractility state of the ventricular cardiac muscle. technological developments in recent years provided a solution to this problem. the analysis of the pressure/volume curves generated by a ventricle allows an accurate quantification of the myocardial contractility. this requires the use of conductance catheters to accurately measure the ventricular volume and the ventricular pressure. the absolute ventricular contractility is then deduced with the help of a software. the investigators intend to use this pressure-volume loops, obtained with conductance catheters, to compare the contractility of the right heart ventricle after antegrade vs retrograde cardioplegia.


Eligibility criteria:
inclusion criteria: * need for myocardial revascularisation * normal fevg ( \> 50%) exclusion criteria: * valvulopathy * associated procedures

Keywords: pv-loops (pressure-volume loops) myocardial contractility cardioplegia induced
a study of combination or sequential treatment with pegasys (peginterferon alfa-2a) and entecavir in patients with hbeag positive chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: this 2 arm study will assess the efficacy and safety of pegasys in combination or sequential treatment with entecavir in patients with hbeag positive chronic hepatitis b. patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. the anticipated time on study treatment is 3-12 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 and \</= 65 years of age * hbeag positive chronic hepatitis b * pre-treatment with entecavir for 9-36 months exclusion criteria: * antiviral, antineoplastic or immunomodulatory treatment * co-infection with active hepatitis a, c or d, or hiv * evidence of decompensated liver disease * history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis