Kornimate/medical-research-clean huggingface dataset:
dose finding for intraoperative photodynamic therapy of glioblastoma

Conditions: Glioblastoma

Summary: the phase ii study evaluate a light dose escalation in a classical intraoperative pdt regimen mediated by 5-ala-ppix, in glioblastoma patients with access to full surgical removal of the contrast enhancement. this treatment will be performed in addition to the current reference treatment of glioblastoma: maximum removal surgery followed by radiochemotherapy according to the stupp protocol.


Eligibility criteria:
inclusion criteria: * general status (who) karnofsky performance status ≥60 * presumptive glioblastoma according to radiological criteria, * surgical indication decided in multidisciplinary consultation meeting (rcp) of neuro oncology, * decision to treat the patient as part of the clinical trial achieved in neuro-oncology rcp ("multidisciplinary consultation meeting") * patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life * clinical neuro-oncological monitoring and long-term mri/ tep 11c met scheduled at the hospital centers * patient able to understand and sign voluntarily informed consent * patient able to adhere to the visit's calendar of the study and other imperatives of the protocol * women of child-bearing potential should benefit of an effective contraception * for patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ala exclusion criteria: * contraindications to 5-ala (gliolan®) and to intra-operative photodynamic therapy "intraoperative pdt": * contraindications to 5-ala * porphyria * taking photosensitizer treatment * severe renal or hepatic impairment * bilirubin\> 1.5 x maximum level, alkaline phosphatases and transaminases (asat)\> 2.5 x maximum. rates * creatinine clearance \<30 ml / min; * non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization * contraindications to surgery * contraindications to magnetic resonance imaging (mri/tep 11c met * treatment with an experimental drug within 30 days prior to the start of the study * clinical follow-up impossible to perform for psychological, familial, social or geographical reasons, * legal incapacity (persons deprived of their liberty or guardianship or guardianship), * pregnant or nursing women * refusal to participate or sign the consent of the study * soy allergy

Keywords: surgical indication of glioblastoma glioblastoma photodynamic therapy neurosurgery oncology 5-aminolevulinic acid
13-valent pneumococcal conjugate vaccine study in adults => 50 years of age in mexico

Conditions: Pneumococcal Infections

Summary: the purpose of this study will be to assess the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vpnc) when given to healthy adults older than 50 years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in mexico.


Eligibility criteria:
inclusion criteria: * male or female older than 50 years of age * eligibility must be determined by medical history, physical exam and clinical judgment * able to complete an electronic diary * available for duration of study * negative pregnancy test for subjects in group 2 age 50 to 64 years * practice abstinence or use reliable birth control if age is 50 to 64 years exclusion criteria: * history of allergic reaction to any vaccine * previous vaccination with licensed or experimental pneumococcal vaccine * s. pneumonia infection within past 5 years before investigational product administration * known or suspected immunodeficiency or received treatment including cytotoxic agents or systemic corticosteroids, serious chronic disorder such as malignancy cancer * receipt of plasma products or immunoglobulins within 60 days * bleeding conditions or diathesis * receipt of investigational product within 28 days before study entry * other severe acute or chronic medical or psychiatric condition

Keywords: prevention of pneumococcal diseases
screening for cancers in the oral cavity

Conditions: Oral Cavity Cancer

Summary: in the somme region of france, cancer registry data showed an increasing incidence of oral cancer. the incidence rates in somme as compared to the national rates for lip, oral cavity and pharynx cancer were in 2010: 31,4/100 000 standard population versus 18,2 /100 000 for male and 8,2/100 000 versus 5,5/100 000 for female, disaster area where action to improve early detection for smokers will be assessed. this target population consults late (as 70% of oral cavity cancers are diagnosed at a late stage (t3 or t4). this project is an innovative incentive strategy for screening among general practitioners based on unusual information vectors (tobacconist, local media). the main objective of this study is a screening of oral cavity cancers in tobacco users aged 30-75 years in the somme region of france.

methodology: * education and alerting physicians to the early detection of cancers of oral cavity and coordination of networks involved for 1 year. * incentive period for the screening by the tobacconist who distributes with every package of cigarettes bought a flyer of invitation to the screening. * carrying out screening examinations by general practitioners with completion of the customized examination forms, orientation towards a specialist, data collection and evaluation.

Eligibility criteria:
inclusion criteria: * any smoker who buys a pack of cigarettes over a period of two weeks in a tobacco shop located on the territory of the somme * lives in somme departement exclusion criteria: -

Keywords: screening cancer tobacco general practitioner precancerous lesion dysplasia tobacco vendor
study to verify proper detection of supraventricular tachyarrhythmia with single-lead dual-chamber implantable cardioverter-defibrillators (adria)

Conditions: Tachyarrhythmia

Summary: a unique single-lead dual-chamber implantable cardioverter-defibrillator (icd) system (produced by biotronik, germany) features a conventional electrode in the ventricle (anchored in the ventricular apex) and a floating electrode (ring on the lead body) in the atrium, capable of sensing atrial electrical signals. the purpose of this study is to determine whether this system detects a supraventricular tachyarrhythmia (e.g. atrial fibrillation, atrial tachycardia) in the equivalent manner as conventional dual-lead dual-chamber icds using two separate electrodes anchored in the ventricle and in the atrium, respectively.

supraventricular tachyarrhythmia (svt) is the main cause of inappropriate therapy in patients with single-chamber implantable cardioverter-defibrillators (icds). to minimize inappropriate shock delivery, icds should sense both atrial and ventricular intracardiac signals. dual-chamber icds are used for this purpose, but are associated with increased postoperative complications due to the implantation of a separate atrial lead. it has to be shown that a novel single-lead dual-chamber icd-system with enhanced svt discrimination can achieve the same specificity in discriminating svt episodes as conventional dual-chamber icd, without the disadvantage of the implantation of several leads. in this study patients eligible for dual-chamber icd therapy who do not need atrial pacing will receive either a single-lead dual-chamber icd (belos a+ and kainox a+ electrode) or a dual-lead dual-chamber icd (belos dr). smart detection algorithm will be used in both study groups for discrimination between atrial and ventricular tachyarrhythmias. atrial tachyarrhythmia episodes are facultatively induced in both groups at implantation or predischarge via a bipolar stimulation catheter. induced episodes and the corresponding icd intervention (detection and therapy or inhibition of therapy) are documented. follow-ups are scheduled for 1, 3, 6 and 12 months after implantation. icd intervention, particularly related to spontaneous svt episodes, will be evaluated based on icd diagnostic memory data interrogated at follow-up controls.

Eligibility criteria:
inclusion criteria: * icd indication according to american college of cardiology/american heart association (acc/aha) guidelines. * informed consent exclusion criteria: * permanent atrial fibrillation * requirement for atrial pacing * patient is underage * no signed patient agreement * patient life expectancy under 6 months

Keywords: implantable cardioverter-defibrillator ventricular tachyarrhythmia supraventricular tachyarrhythmia electric countershock
individualized perioperative open-lung ventilatory strategy during one-lung ventilation

Conditions: Thoraric Surgery; Surgery Time Expected More Than Two Hours

Summary: the purpose of this study is to determine whether individualized ventilatory management during one-lung ventilation in patients scheduled for thoracic surgery, combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and individually indicated ventilatory support will decrease postoperative pulmonary complications, icu and hospital length of stay compared to a standardized lung protective ventilation (lpv).


Eligibility criteria:
inclusion criteria: * planned thoracic surgery \> 2 hours. * signed informed consent for participation in the study. exclusion criteria: * age less than 18 years. * pregnant or breast-feeding. * patients with bmi \>35. * syndrome of moderate or severe respiratory distress: pao2/fio2 \< 200 mmhg. * heart failure: nyha iv. * hemodynamic failure: ci \<2.5 l/min/m2 and / or requirements before surgery ionotropic support. * diagnosis or suspicion of intracranial hypertension (intracranial pressure\> 15 mmhg). * mechanical ventilation in the last 15 days. * presence of pneumothorax. presence of giant bullae on chest radiography or computed tomography (ct). * patient with preoperatively cpap. * participation in another experimental protocol at the time of intervention selection.

Keywords: one lung ventilation postoperative pulmonary complication perioperative lung protective ventilation
effect of sinovac on survival in intensive care unit

Conditions: Survival; Intensive Care Unit

Summary: effect of inactivated covid-19 vaccine (sinovac) on survival in intensive care unit, single center experience

turkey has started vaccinate healthcare professionals at 13 january 2021 by sinovac vaccine and declared a step by step inclusion schedule the primary aim of the study is to compare clinical, laboratory and survival data of covid-19 patients who were vaccinated at least 14 days before enrollment to the study with covid-19 patients not vaccinated although they would have. the secondary aim is to compare age of enrolled patients to icu due to sars-cov-2 infection with patients admitted to icu before start of vaccination program.

Eligibility criteria:
inclusion criteria: * patients with covid 19 over the age of 65 who were admitted to the intensive care unit between 1 april 2021 and 15 may 2021 exclusion criteria: * admissions to icu due to reasons other than covid-19, age younger than 65, continued admission at the end of enrolment date,

Keywords: covid-19 vaccine sinovac
surfactant for neonate with acute respiratory distress syndrome (ards)

Conditions: ARDS; RDS; Surfactant

Summary: acute respiratory distress syndrome (ards) in neonates has been defined, the role of surfactant is not clear. this study aimed to determine whether ards neonate would benefit from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

to date, surfactant is not recommended to adult and pediatric ards. meantime, systematic review indicates that surfactant does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of bronchopulmonary dysplasia(bpd) in term and late preterm infants with meconium aspiration syndrome. therefore, a reasonable speculation is that preterm infants with ards do not benefit from one dose of surfactant. and the speculation can explain why not all preterm infants with respiratory distress can be beneficial from surfactant. in the era of pre-ards, the preterm infants fulfilling the definition of ards may have been considered as respiratory distress syndrome (ards) in the first three days after birth. according to the diagnostic criteria of neonatal ards, a key procedure for diagnosis of neonatal ards is to exclude the newborn infants with rds. but no detailed procedures are available to differentiate rds from ards according the guideline of european rds and definition of neonatal ards. therefore, there are two aim in the present study. 1. to proposel a new definition of rds; 2. to assess the beneficial effects of surfactant on neonatal ards.

Eligibility criteria:
inclusion criteria: 1. infant less than 28 days 2. diagnosis of ards or rds or both 3. informed parental consent has been obtained exclusion criteria: 1. major congenital malformations or complex congenital heart disease or chromosomal abnormalities 2. transferred out of the neonatal intensive care unit without treatment 3. upper respiratory tract abnormalities
a study of tirzepatide (ly3298176) once a week versus insulin glargine once a day in participants with type 2 diabetes and increased cardiovascular risk

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the trial is to assess the efficacy and safety of tirzepatide taken once a week to insulin glargine taken once daily in participants with type 2 diabetes and increased cardiovascular risk. the study will last about 108 weeks and may include up to 30 visits.


Eligibility criteria:
inclusion criteria: participants must: * have been diagnosed with type 2 diabetes mellitus (t2dm) * have hba1c between ≥7.5% and ≤10.5% * be on stable treatment with unchanged dose of at least 1 and no more than 3 types of oral antihyperglycemic drugs, which may only include metformin, sglt-2 inhibitors, and/or sulfonylureas for at least 3 months before screening * have increased risk for cardiovascular (cv) events * be of stable weight (± 5%) * have a bmi ≥25 kilograms per meter squared (kg/m2) at screening exclusion criteria participants must not: * have type 1 diabetes mellitus * have had chronic or acute pancreatitis any time prior to study entry * have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment * have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss * have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (alt) enzyme level \>3.0 times the upper limit of normal (uln) for the reference range, as determined by the central laboratory. participants with nonalcoholic fatty liver disease (nafld) are eligible for participation in this trial only if there alt level is ≤3.0 the uln for the reference range * have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months * have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2 * have been taking any other diabetes medicines other than metformin, sglt-2 inhibitors, and/or sulfonylureas during the last 3 months * have been taking weight loss drugs, including over-the-counter medications during the last 3 months

Keywords: gip glp-1 glucose metabolism disorders metabolic diseases endocrine system diseases cardiovascular risk
persistent pain among elderly experiencing motor vehicle collision

Conditions: Persistent Pain After Injury; Functional Decline After Injury

Summary: chronic problems after traumatic events are common in non-elderly adults. previous studies have shown that after minor motor vehicle collision (mvc), 10-30% of non-elderly adult patients develop chronic regional pain (neck or back pain). in addition, up to 1/3 of non-elderly adults will develop psychological sequelae, including posttraumatic stress disorder, depression, and anxiety disorders. there have been no prospective studies examining the frequency or predictors of persistent pain or psychological sequelae in older adults. the proposed study seeks to determine the frequency of persistent pain, psychological sequelae, and associated disability in older adults after minor mvc trauma and to identify candidate predictors for a model of adverse outcomes after mvc in this population. 200 individuals over 65 years of age will be recruited from emergency departments in four states with no-fault accident laws. patients who meet inclusion criteria and who consent to the emergency department (ed) study will undergo a 30-45 minute ed assessment of crash-related, psychosocial, and biological factors, and complete telephone follow-ups at 2 weeks, 6 weeks 6 months, and 12 months. the wealth of information gained from this study will be used to determine the frequency of adverse events in older adults after mvc and to identify high risk elderly patients. these results will inform subsequent development of secondary pharmacologic and/or behavioral interventions to prevent chronic pain and psychological sequelae after traumatic events in older adults.


Eligibility criteria:
inclusion criteria: * patient speaks english, presented to er less than 24 hours after an mvc, patient has an address and telephone exclusion criteria: * patient * is a prisoner, * has fractures or an intracranial injury, * has injuries that are life threatening or expected to result in hospitalization for more than 72 hours, * is receiving end of life, hospice, or comfort care, or * is considered ineligible by treating physician.

Keywords: pain
a pilot study to evaluate the efficacy of montelukast in the treatment of acute otitis media (aom) in children

Conditions: Acute Otitis Media; Otitis Media; Ear Infection

Summary: the objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute otitis media (aom)

otitis media (om) is one of the most common childhood disorders requiring physician care and has been associated with an alarming rise in prevalence. certain children are prone to recurrent episodes of acute otitis media (raom) and/or the development of chronic otitis media with effusion (come). because medical therapy with antibiotics, antihistamines, decongestants and corticosteroids has no demonstrable efficacy, the mainstay of treatment is surgical intervention, which is quite expensive and exposes patients to risks of general anesthesia. the objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute otitis media (aom)

Eligibility criteria:
inclusion criteria: * aged 18 months to 5 years old. * diagnosis of current aom exclusion criteria: * presence of primary or secondary immunodeficiency, craniofacial abnormality, cleft palate, anatomic predisposition, major congenital anomaly or syndrome, or severe systemic disease * use of: * any investigational medications within the past 30 days, systemic or oral or nasal steroids within the past 30 days * accolate® in the past 7 days * antibiotics within the past week, except for zithromax®, which will be 21 days * long acting second generation antihistamines (i.e., claritin®, clarinex®, allegra® and zyrtec®) within the past 72 hours. * no known allergy to either montelukast or amoxicillin/clavulanate * have not responded to augmentin® in the past

Keywords: ear infections otitis media
long-term administration study of aripiprazole as an adjunctive therapy in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: to examine the safety and efficacy of long term administration of aripiprazole as an adjunctive therapy, co-administered with either a selective serotonin reuptake inhibitor (ssri) or a selective-norepinephrine reuptake inhibitor (snri), in subjects with major depressive disorder.


Eligibility criteria:
inclusion criteria: 1. patients who are either inpatients or outpatients 2. patients who have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial 3. patients diagnosed as having either "296.2x major depressive disorder, single episode" or "296.3x major depressive disorder, recurrent" according to dsm-iv-tr, and for whom the current episode of major depressive disorder has been ongoing for more than 8 weeks. exclusion criteria: 1. female patients of child bearing potential who wish to become pregnant during the treatment period, or within 4 weeks after study completion/discontinuation 2. female patients who are pregnant, possibly pregnant, or breast feeding 3. patients judged to be unable to tolerate any type of antidepressant treatment (including drugs not being used in the current episode of major depressive disorder), based on treatment history to date 4. patients who have previously received electro-convulsive therapy 5. patients who have participated in clinical studies on medical devices or other drugs within the past month 6. patients at risk of having serious adverse events or developing symptoms that could interfere with safety and efficacy evaluations (such as symptoms of fibromyalgia syndrome overlapping with symptoms of depression), based on previous medical history 7. patients with a history or a complication of diabetes 8. patients with thyroid disease (excluding patients who are stabilized on drug therapy for at least 3 months) 9. patients with a history of serotonin syndrome or psychotropic neuroleptic malignant syndrome 10. patients with a history of seizure disorder (epilepsy etc.)
the effect of portable ar on tooth brushing skill for elementary school students

Conditions: Healthy

Summary: the aim of this study an augmented reality (ar) simulation toothbrushing machine was developed to train proper brushing technique for children. the investigators aimed to evaluate the effects of ar brushing machine on knowledge of dental clearing skill, self-efficacy and dental plaque control in elementary schoolchildren in taiwan.

a quasi-experimental design was conducted; ten intervention schools (ar group) and ten comparison schools were selected from elementary schools. overall, grade 3-6 students in the ar group (n = 290) and the traditional group (n = 311), respectively. students in the ar group received a two-time repeated ar-based training for 30 minutes at two-week intervals. students in the cg received traditional classroom-based teaching. baseline and follow-ups information was collected using dental plaque examinations and questionnaires. the generalized estimating equations(gee) were used to evaluate the outcomes between two groups over time.

Eligibility criteria:
inclusion criteria: * primary school students 3 to 6 grades exclusion criteria: * schoolchildren with disability certification. * schoolchildren with congenital severe oral diseases (eg. cleft lip and palate ) * disability to operate the ar system

Keywords: augmented reality dental plaque schoolchildren