Kornimate/medical-research-clean huggingface dataset:
developing a childhood asthma risk passive digital marker

Conditions: Pediatric Asthma

Summary: underdiagnosis and undertreatment is a major problem in childhood asthma management, especially in preschool-aged children. current prognostic approaches using risk-score based tools have poor-to-modest accuracy, are impractical, and have limited evidence of efficacy in clinical settings and hence are not widely used in practice. the objective of the study is to determine the usability, acceptability, feasibility, and preliminary efficacy of the childhood asthma passive digital marker (pdm) among pediatricians. the study will include practicing pediatricians within the iu health network.


Eligibility criteria:
inclusion criteria: • practicing pediatricians within the iu health network exclusion criteria: • non-practicing pediatricians within the iu health network

Keywords: pediatric asthma early detection screening passive digital marker risk factors
study of cerebrolysin for treatment of infants with history of neonatal hypoxic ischemic encephalopathy

Conditions: Hypoxic-Ischemic Encephalopathy

Summary: the purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic encephalopathy after hospital discharge.

infants with perinatal history of moderate to severe hypoxic ischemic encephalopathy hie will receive 10 injections of cerebrolysin im. assessment of neurodevelopment will be done before , 3 and 6 months after therapy

Eligibility criteria:
\*inclusion criteria: infant aged 3-6 months with perinatal history of moderate or severe hie collected from his nicu's file. criteria of neonatal asphyxia and encephalopathy according to the american college of obstetricians and gynecologist and american academy of pediatrics, metabolic acidosis with a cord ph of 7.0 or less or a base deficit of at least 12 mmol/l, early onset of encephalopathy, and multisystem organ dysfunction with exclusion of other possible causes for findings. criteria of neonatal asphyxia: * full term neonate more than 36 weeks of gestation * ph of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical-cord blood or any blood during the first hour after birth. * if, during this interval, a ph is between 7.01 and 7.15, a base deficit is between 10 and 15.9 mmol per liter, or a blood gas is not available, additional criteria are required. these includes an acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest) and either a 10-minute apgar score of 5 or less or assisted ventilation initiates at birth and continues for at least 10 minutes. criteria of neonatal encephalopathy according to sarnat and sarnat. presence of one or more signs in at least three of the following six categories: * level of consciousness. * spontaneous activity. * posture. * tone. * primitive reflexes (suck or moro. * autonomic nervous system (pupils, heart rate, or respiration). the number of moderate or severe signs determined the extent of encephalopathy; if signs were equally distributed, the designation was based on the level of consciousness. \*exclusion criteria: * severe intrauterine growth retardation. * congenital malformations. * suspected inborn error of metabolism. * suspected inherited neurologic disease. * intracranial hemorrhage * meningitis

Keywords: hypoxic ischemic encephalopathy (hie) perinatal asphyxia nerve growth factor cerebrolysin cerebral palsy
rehabilitation methods of children with cochlear implant

Conditions: Deafness Neurosensory

Summary: the goal of this observational study is to describe the type of the rehabilitation method for italian children with cochlear implant . the main questions are: what is the most used rehabilitation methods in implanted children? which is the prevalence of each method related to the clinical features of the patients?

the cochlear implant represents the gold standard in the treatment of children with bilateral severe-profound deafness. however, the current italian and international guidelines do not address the issue of rehabilitation and how the different rehabilitation methods should be applied in relation to the different clinical pictures. the aim of this study is therefore to describe which methods are used today in the rehabilitation of deaf children with cochlear implants followed at the phoniatrics and speech therapy service of the a. gemelli polyclinic foundation. the creation of a questionnaire directed to the speech therapist who treats the specific patient is available in order to collect data concerning the characteristics of the setting and the rehabilitation method in relation to the most applied methodologies, i.e. auditory-verbal therapy, oral-cognitive therapy, bimodal method and the drežančić method. inclusion criteria: * children diagnosed with severe-profound hearing loss and cochlear implant carriers followed at the fondazione policlinico universitario a. gemelli in the last 10 years; * age \>12 months and \<10 years exclusion criteria: * children diagnosed with mild to moderate hearing loss without a cochlear implant; * age \ 10 years outcomes measures * describe which methods are used today in the rehabilitation of the deaf child with a cochlear implant * describe the prevalence of the different methodologies in relation to the clinical characteristics of the patients. endpoints: -% distribution of the 4 rehabilitation methods: cognitive oralism, verb-tonal, auditory-verbal therapy and bimodal - % distribution of the 4 rehabilitation methods: cognitive oralism, verbal-tonal, auditory-verbal therapy and bimodal in relation to the clinical characteristics of the patients.

Eligibility criteria:
inclusion criteria: * patients diagnosed with severe to profound hearing loss who underwent cochlear implant placement surgery in the last 10 years; * age \>12 months and \<10 years exclusion criteria: * patients diagnosed with mild to moderate hearing loss without a cochlear implant * age \ 10 years

Keywords: cochlear implant deafness rehabilitation
post market clinical follow-up study protocol for profemur® tl modular femoral stems

Conditions: Joint Disease

Summary: sponsor is conducting this post market clinical follow-up (pmcf) study to evaluate the safety and efficacy of its total hip arthroplasty (tha) marketed in the european union (eu) . these types of studies are required by regulatory authorities for all tha devices that do not have clinical evidence available at the time of gaining approval to market in the eu. this study has been designed in accordance with meddev 2.12/2 rev 2.

total hip arthroplasty (tha) has been performed since the early 1920s and is generally considered to be one of the most successful orthopedic surgeries performed. the 8th annual report from the national joint registry of england and wales reported 95.3% component survivorship at 7 years for over 300,000 tha implantations. microport orthopedics, inc. (mpo) currently markets several tha components throughout the world, including the european union (eu). as part of the process for gaining approval to market in the eu, mpo is conducting this post market clinical follow-up (pmcf) study to evaluate the safety and efficacy of these tha components. the objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.

Eligibility criteria:
inclusion criteria: * has undergone primary tha for any of the following: * non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia; * inflammatory degenerative joint disease such as rheumatoid arthritis; or * correction of functional deformity * subject is implanted with the specified combination of components * subject is willing and able to complete required study visits or assessments exclusion criteria: * subjects implanted with dynasty® biofoam® acetabular shells * subjects implanted with a metal-on-metal articulation * subjects implanted with non-microport orthopedics components (femoral heads, acetabular shells, acetabular liners) in the enrolled tha * subjects skeletally immature (less than 21 years of age) at time of primary tha surgery * subjects currently enrolled in another clinical study which could affect the endpoints of this protocol * subjects unwilling to sign the informed consent document * subjects with substance abuse issues * subjects who are incarcerated or have pending incarceration

Keywords: osteoarthritis avascular necrosis ankylosis protrusio acetabuli painful hip dysplasia rheumatoid arthritis correction of functional deformity revision procedures
intubating conditions during propofol-remifentanil anesthesia with topical lidocaine

Conditions: Drug Usage

Summary: when not using neuromuscular blocking agent, even at optimal dosage, target-controlled infusion (tci) of propofol and remifentanil occasionally produce unsatisfactory intubating conditions. therefore, the investigators evaluated that the effect of tracheal lidocaine on the intubating conditions for tracheal intubation during anesthesia induction of propofol and remifentanil tci without neuromuscular blocking agent in day-case anesthesia.

anesthesia was induced with propofol-remifentanil tci with the effect-site concentration of 5μg/ml and 5ng/ml, respectively. after tci, 3 ml of normal saline or 3 ml of 4% lidocaine was instilled to larynx and trachea, following intubation was performed.

Eligibility criteria:
inclusion criteria: * asa i, ii patients undergoing general anesthesia for reduction of nasal bone fracture exclusion criteria: * bronchial asthma, * copd, * hypertension, * anticipated difficult airway

Keywords: intubating conditions propofol remifentanil topical lidocaine
eylea [amd-qol(age-related macular degeneration-quality of life)] post-marketing surveillance in japan

Conditions: Macular Degeneration

Summary: the objective of this survey is to evaluate effectiveness of eylea on quality of life (qol). the qol is evaluated by using japanese version (v.1.4 - interviewer administered format) of national eye institute visual function questionnaire-25 (nei vfq-25) and compared at baseline and at the 6 and 12 months after start of eylea treatment.


Eligibility criteria:
inclusion criteria: * patients who have been determined to start eylea treatment * patients who are registered to special drug use investigation of eylea for amd(trial number 15858) * patients who have agreed with the patient informed consent exclusion criteria: * patients who have already received eylea

Keywords: eylea age-related macular degeneration qol
very early fdg-pet/ct-response adapted therapy for advanced hodgkin lymphoma (h11)

Conditions: Hodgkin Lymphoma

Summary: the main objective of the trial is to show that doxorubicin, bleomycin, vinblastine, and dacarbazine (abvd)-based response-adapted therapy for advanced-stage hodgkin lymphoma, with treatment intensification (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone (beacoppesc) in case of a positive fluorodeoxyglucose (fdg) positron emission tomography (pet) computed tomography (ct) after one cycle of abvd, has non-inferior efficacy compared with the intensive beacoppesc regimen. a second objective is to assess the prognostic value of fdg-pet/ct after one cycle of beacoppesc.


Eligibility criteria:
inclusion criteria: * previously untreated, histologically proven classical hodgkin lymphoma * clinical stages iii/iv (ann arbor) * age 18-60 * who performance 0-2 * adequate organ function * patients of childbearing/reproductive potential should use adequate birth control measures during the whole duration of study treatment. * written informed consent according to ich/eu good clinical practice, and national/local regulations exclusion criteria: * pregnancy or lactation * specific contraindications to beacoppesc therapy, including: * poorly controlled diabetes mellitus * hiv infection, * chronic active hepatitis b and/or hepatitis c * concomitant or previous malignancies with the exception of basal cell skin tumors, adequately treated carcinoma in situ of the cervix and any cancer that has been in complete remission for \>5 years * psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Keywords: advanced stage
lasik flap thickness and visual outcomes using the wavelight fs200 femtosecond laser

Conditions: Myopia

Summary: the objective of this study is to evaluate the visual outcome, accuracy, predictability and complications of lasik flap creation using the alcon wavelight fs200 femtosecond laser and compare these results to those obtained using current intralase fs60 femtosecond laser. the primary outcome to be evaluated is the flap thickness accuracy.

laser in situ keratomileusis (lasik) is a method for treating myopia, hyperopia and astigmatism. in lasik, the cornea is reshaped to focus images more clearly on the retina without the aid of glasses or contact lenses. lasik involves two steps: creation of a corneal flap, which can be performed by a mechanical microkeratome or a femtosecond laser, and reshaping of the cornea by another laser, an excimer laser. the accuracy of the lasik flap thickness is a key safety consideration to reduce the likelihood of complications following lasik. femtosecond laser technology has significantly improved the predictability of lasik flap dimensions while supporting similar visual acuity results. the alcon fs200 femtosecond laser is approved for human use by the united states food and drug administration and was recently released in the us market. this study will directly compare outcomes of lasik performed with this newer laser to those performed with the amo intralase femtosecond laser.

Eligibility criteria:
inclusion criteria: * all patients with ametropia (spherical, spherocylindrical, presbyopic) suitable for treatment by lasik, including different target refractions (plano or monovision). exclusion criteria: * patients unsuitable for lasik procedure because of an estimated residual stromal bed \< 300 microns after calculation of the ablation (corneal thickness - flap thickness - simulated stromal ablation for the desired correction). * patients unsuitable for lasik due suspicious topography for ectasia, form frust keratoconus or unstable ( more than 0.50 diopter change in sphere or cylinder in the last year) refraction. * patients with amblyopia or any eye disease that might limit the visual recovery. * patients younger than 18 years old.
complications associated with partial nephrectomy for renal cancer

Conditions: Renal Cancer; Partial Nephrectomy

Summary: this paper evaluates the initial complications and the complications two years postoperatively necessitating re-hospitalisation for three surgical procedures for renal tumour partial nephrectomy .

this paper evaluates the initial complications and the complications two years postoperatively necessitating re-hospitalisation for three surgical procedures for renal tumour partial nephrectomy (open (opn), standard laparoscopy (lpn) and robot assisted laparoscopy (rapn)) in 2016-2017 in france (9119 initial hospitalisations included 4035 opn, 1900 rapn, 1709 lpn). the investigators have extracted for these all hospitalisations from the french national hospital data base (pmsi-mco). the investigators concluded mini-invasive and robotic surgery had lower morbidity and a shorter initial hospitalisation.

Eligibility criteria:
inclusion criteria: * hospitalisations between the 1st january 2016 and the 31st december 2017 with one of the partial nephrectomy codes exclusion criteria: * partial nephrectomy for non-cancerous pathology * no technical information

Keywords: nephron sparing robot pmsi laparoscopy open surgery nephron sparing surgery
spinal met_radiosurgery/sbrt study

Conditions: Spine Metastasis

Summary: demonstrate the technical feasibility of treating spine metastases with image-guided radiosurgery/sbrt


Eligibility criteria:
inclusion criteria: 1. the patient must have localized spine metastasis from the c1 to l5 levels by a screening imaging study (bone scan, pet, ct, or mri). a solitary spine metastasis; two separate spine levels; or up to 3 separate sites are permitted. each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies. a paraspinal mass ≤ 5 cm is allowed. 2. zubrod performance status 0-2; 3. age ≥ 18; 4. history/physical examination within 2 weeks prior to registration; 5. no pregnancy for women of childbearing potential; 6. mri of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement. mri is required as it is superior to a ct scan in delineating the spinal cord as well as identifying an epidural or paraspinal soft tissue component. if possible, an mri with thin slice thickness (\<1mm) with 3d reconstruction quality would be most preferable for treatment planning purpose. 7. numerical rating pain scale within 1 week prior to registration. the patient must have a score on the scale of ≥ 4 for at least one of the planned sites for spine radiosurgery. patients taking medication for pain at the time of registration are eligible. 8. neurological examination within 1 week prior to registration to rule out rapid neurologic decline; see appendix iv for the standardized neurological examination. patients with mild to moderate neurological signs are eligible. these neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function). 9. patients with epidural compression are eligible provided that there is no significant displacement or compression on the spinal cord itself. 10. patients with a paraspinal mass ≤ 5 cm in the greatest dimension and that is contiguous with spine metastasis are eligible. 11. patients must provide study specific informed consent prior to study entry. exclusion criteria: 1. histologies of myeloma or lymphoma. 2. patients with any spine metastasis with a rating of \< 4 on the numerical rating pain scale. 3. non-ambulatory patients. 4. spine instability due to a compression fracture. 5. \> 50% loss of vertebral body height. 6. significant spinal cord compression or displacement. 7. patients with rapid neurologic decline. 8. bony retropulsion causing neurologic abnormality. 9. prior radiation to the index spine. 10. patients for whom an mri of the spine is medically contraindicated.

Keywords: spine metastasis sbrt radiosurgery
postendodontic pain on using max-i-probe vs navitip as irrigation needles

Conditions: Symptomatic Irreversible Pulpitis

Summary: the aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented max-i-probe versus the end-vented navitip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth.

the aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented max-i-probe versus the end-vented navitip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth. medical and dental history was obtained from all participants in this trial and clinical examination for teeth was performed. participants with symptomatic irreversible pulpitis were included. after access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (max-i-probe) or control group (navitip). one-visit root canal treatment was performed . each patient received a 48-h diary to record postoperative pain. post-operative pain was measured at the following time points: 4, 12, 24 and 48 hours after root canal treatment.

Eligibility criteria:
inclusion criteria: 1. age: 16-65 year old. 2. medically free. 3. mandibular posterior teeth with symptomatic irreversible pulpitis. 4. no sex predilection exclusion criteria: 1. pregnant females. 2. history of allergy to any medication used in the study. 3. preoperative premedication less than 6 hours before procedure. 4. cracked teeth and teeth with badly-decayed crowns.
kdigo bundle to prevent aki in sepsis

Conditions: Septic Acute Kidney Injury

Summary: summary: controlled, prospective, randomized and randomized clinical trial of two intervention groups (standard care vs. preventive recommendations the kidney disease: improving global outcomes (kdigo) guidelines for aki) of patients diagnosed with sepsis and abdominal post-surgical septic shock with positive results in the risk determination of acute renal injury by nephrocheck® test that integrates the urinary biomarkers timp-2 and igfbp-7. hypothesis: the implementation of a package of preventive measures proposed by the kdigo guide can reduce the occurrence and severity of acute renal injury in the high-risk abdominal post-surgical septic patient detected by urinary biomarkers for early detection.


Eligibility criteria:
inclusion criteria: * patients older than 18 years. * patients (or their informed family members) who accept and sign the informed consent. * patients diagnosed with sepsis or abdominal post-surgical septic shock. exclusion criteria: * patients under 18 years. * patients (or their authorized relatives) who refuse to sign the informed consent. * patients diagnosed with sepsis or non-surgical septic shock. * patients diagnosed with sepsis or septic shock of origin other than abdominal. * patients with aki stages kdigo 2 and 3 and / or renal replacement therapy. * patients with chronic renal failure and glomerular filtration \<30 ml / min and / or undergoing treatment with dialysis or previous renal transplantation. * patients with aki of origin other than the diagnosed septic, such as glomerulonephritis or interstitial nephritis, renal artery occlusion and / or postrenal obstruction.
deb-tace treatment in 367 liver cancer patients

Conditions: Liver Cancer

Summary: introduction:the drug-eluting beads transarterial chemoembolization (deb-tace) is introduced to better improve efficacy and reduce the systemic toxicity in liver cancer patients on account of its higher intratumoral chemotherapeutic drug concentration and reduced drug infiltration into systemic circulation. this study aimed to investigate the efficacy, safety and prognostic factors of deb-tace treatment in chinese patients with liver cancer. hypothesis:deb-tace illustrates a better treatment response, progression free survival (pfs), overall survival (os) and less common adverse events (aes) in liver cancer patients. objective: to investigate the efficacy, safety and prognostic factors of deb-tace treatment in chinese patients with liver cancer.


Eligibility criteria:
inclusion criteria: 1. diagnosed as primary hcc, primary icc or secondary liver cancer confirmed by pathological findings, clinical features or radiographic examinations according to american association for the study of the liver diseases (aasld) guidelines; 2. age above 18 years; 3. about to receive deb-tace treatment with callispheres® according to clinical needs and patients' willing. 4. able to be followed up regularly; 5. life expectancy above 12 months. exclusion criteria: 1. history of liver transplantation; 2. history of hematological malignances; 3. severe hepatic failure or renal failure; 4. contraindication for angiography, embolization procedure or artery puncture; 5. patients with cognitive impairment, or unable to understand the study consents. 6. women in gestation or lactation period.