Kornimate/medical-research-clean huggingface dataset:
investigation of the usability of the dynamic scaffolding system

Conditions: Child Development Disorder; Child Development; Assistive Technology

Summary: the aim of the present study was to compare the duration of use of the dynamic scaffolding system (dss) in children with different levels of motor impairment, to report adverse events during use, and to examine parental satisfaction. one hundred children with special needs aged between 9 and 108 months who had used the dss device for at least 6 months and their parents were included in the study. the duration of daily use of the dss device by the children, any adverse events during use, and parental satisfaction were assessed using the quebec 2.0 assistive technology user satisfaction assessment questionnaire.

children with special needs with mobility difficulties use various assistive devices to benefit from the beneficial effects of standing upright and moving. these devices have beneficial effects on improving children's motor skills and increasing their social interaction and participation. in addition, during the use of assistive devices, there are some limitations related to size, weight, usability, mobility, and adaptability to children. considering these limitations, the dynamic scaffolding system (dss) device was developed. the dss device aims to position children with moderate to severe mobility impairment vertically (standing and sitting) and to step with support. the aim of the current study was to compare the duration of use of the dynamic scaffolding system (dss) device in children with different levels of motor impairment, to report adverse events during use, and to examine parental satisfaction. one hundred children with special needs (60% cerebral palsy, 40% other diagnoses: genetic, metabolic, neuromuscular diseases) aged between 9 and 108 months (mean 44.94±17.59) and their parents (94% mother, 6% father) who had used the dss device for at least 6 months were included in the study. data were collected from the participants via telephone interview. demographic data such as age, gender, diagnosis, and level of motor impairment were recorded. children's daily use of the dss device, any adverse events during use, and parental satisfaction were assessed using the quebec 2.0 assistive technology user satisfaction assessment questionnaire.

Eligibility criteria:
inclusion criteria: * children with motor disabilities exclusion criteria: * if children did not use dynamic scaffolding system for less than one month

Keywords: children with disability assistive device walker children dynamic scaffolding system parental satisfaction
urinary biomarkers for objective measurement of interstim® response in over active bladder (oab) patients.

Conditions: Overactive Bladder

Summary: the goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (oab) and interstim®.

this study will look for changes in protein markers that might reflect bladder symptoms before and after interstim® implant.

Eligibility criteria:
oab subjects (n=10 phase i and n=10 phase ii) inclusion criteria: * female * age 18-75 years * clinical symptoms of oab (urgency and frequency with or without urge incontinence) for at least 3 or the 6 months immediately before the first visit. * at least 8 voids/day and an average of 1 nocturnal void over 3 consecutive days on baseline bladder diary. * interstim® treatment naïve or being revised with a new lead exclusion criteria: * pelvic mass, pelvic prolapse, urinary retention, and pelvic malignancies as revealed by physical examination/medical record review * implanted programmable generator (ipg) is not implanted/connected to the tined lead (failed stage i) * revision of only the ipg (without replacement of the tined lead) * more than one interstim® device being placed (undergoing bilateral stimulation) controls (n=10) inclusion: * female * age 18-75 years * deny history of oab diagnosis or symptoms (urgency and frequency with or without urge incontinence) * american urological association (aua) symptom score of ≤4 exclusion: -history of pelvic mass, prolapse, urinary retention, or pelvic malignancy within the last year
safeboosc-iiiv - does cerebral oximetry monitoring affect renal outcomes

Conditions: Acute Renal Failure; Neonatal Morbidity

Summary: cerebral oximetry monitoring allows clinicians to optimize blood flow to the brain and oxygenation using the safeboosc treatment guideline. the guideline's interventions aims to stabilize blood pressure and oxygen levels. as low blood pressure is a risk factor for the development of kidney injury, normalizing blood pressure may decrease the incidence of kidney injury in new-borns who are on ventilator.


Eligibility criteria:
inclusion criteria: * \> 28 weeks of gestation invasively ventilated exclusion criteria: * major anomalies

Keywords: cerebral oximetry nirs neonate ventilated kidney injury
to evaluate the efficacy of capsimax on metabolic rate

Conditions: Metabolism

Summary: capsimax™ is a proprietary capsicum extract that employs beadlet technology. in the previous study it has been used to investigate its effect in reducing body fat/weight and increase metabolic rate. in this study, capsimax™ will be used to assess effect on resting energy expenditure (ree) using indirect calorimetry.


Eligibility criteria:
inclusion criteria: * healthy, adult, male/female participants with age ≥ 18 ≤ 55 years. * a body mass index (bmi) between 18.5 to 29.9 kg/m2. * fasting blood sugar ≤ 100 mg/dl * hemoglobin: males ≥ 11 g/dl and females ≥ 10 g/dl * bp \< 140/90 mmhg exclusion criteria: * post-menopausal females * history of hypo/ hyperthyroidism. * history of significant neurological or psychiatric condition such as seizures, depression, or insomnia.
pharmacokinetic study of ceftaroline fosamil/avibactam in adults with augmented renal clearance

Conditions: Augmented Renal Clearance (ARC); Systemic Inflammatory Response Syndrome (SIRS)

Summary: to evaluate the pharmacokinetic (pk) profiles of ceftaroline and avibactam in adults with augmented renal clearance (arc).

to evaluate the single-dose pharmacokinetic (pk) profiles of ceftaroline and avibactam following intravenous (iv) administration of ceftaroline fosamil/avibactam ("cxl") in adults with augmented renal clearance (arc).

Eligibility criteria:
inclusion criteria: * male or female adults ≥ 18 and ≤ 55 years old * augmented renal clearance, defined as: * estimated crcl ≥ 115 ml/min (calculated using modified cockcroft-gault, before the measured 8-hour urine collection) * measured crcl ≥ 140 ml/min (from an 8-hour urine collection) * hospitalized and diagnosed with sirs, defined by at least 2 of the following: * temperature (oral, rectal, tympanic, or core) \> 38.5°c or \< 35.0°c * heart rate \> 90 beats/min * respiratory rate \> 20 breaths/min or paco2 \< 32 mmhg * leukocytosis (\> 12,000 white blood cells \[wbc\]/mm3), leukopenia (\ 10% immature neutrophils \[bands\] regardless of total peripheral wbc) * requires indwelling urinary bladder catheter per standard of care (through the end of the 8-hour urine collection) exclusion criteria: * history of any known hypersensitivity or allergic reaction to cephalosporins or any β-lactam antimicrobial (eg, penicillins) * history of chronic kidney disease, hemodialysis, or peritoneal dialysis; or history of acute renal replacement therapy (eg, hemodialysis, hemofiltration) associated with current illness * suspected rhabdomyolysis or creatine kinase \> 10,000 u/l * significant anemia defined as hemoglobin \< 9 g/dl or hematocrit \< 27% * transfusion of packed red blood cells (prbc) or whole blood within 24 hours of study drug infusion or anticipated need for a transfusion before the last pk blood sample is collected * if female, currently pregnant or breastfeeding
multimodal music therapy for children with anxiety disorders

Conditions: Anxiety

Summary: multimodal music therapy (mt) for children ages 8 to 12 years with anxiety disorders is compared to community treatment as usual (tau). 36 children were randomized either to mt or to tau. primary outcome is presence of an anxiety disorder at the end of treatment. secondary outcomes are self- and parent-/teacher reported anxiety, co-morbid psychological symptoms, and quality of life. stability of outcome is assessed six months after the end of treatment.

patients were enrolled in a community clinic and in an outpatient clinic for child and adolescent psychiatry/psychotherapy. inclusion criteria: diagnosis of an anxiety disorder (separation anxiety disorder, general anxiety disorder, social phobia, specific phobia, or other anxiety disorder); age 8-12; no medication or stable medication during treatment; iq\>80; informed consent of caregivers and informed assent of patients. outcome measures. kiddie-sads; staic-c, spaic, cdi; sdq teacher report; cbcl 4-18; ilk quality of life inventory. assessment time points: pre-intervention; post-intervention; 6-months follow-up.

Eligibility criteria:
inclusion criteria: * age 8-12 years * diagnosis of an anxiety disorder * iq\>80 * informed consent and assent exclusion criteria: * anxiety disorder is not primary focus of treatment

Keywords: music therapy multimodal psychotherapy children anxiety disorders pediatric anxiety
evaluation of the onset and duration of action of rx-10045 in allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: to purpose of this study is to establish the efficacy and safety of rx-10045 ophthalmic solution in alleviating the signs and symptoms of allergic conjunctivitis

allergies are relatively common among the general population. ocular signs and symptoms include itching, discomfort, redness, chemosis, tearing, and eyelid swelling. allergic reactions can vary from a mild, self-limiting disease, to a debilitating condition that significantly impairs the quality of life of allergen-sensitive individuals. currently approved treatments for ocular allergy reduce the signs and symptoms of the early phase reaction; however, evidence suggests that many patients suffer from the persistent late phase reaction. manifestations of the late phase reaction occur 6 to 24 hours after allergen exposure and are characterized by an influx of acute inflammatory cells into the conjunctivae. administration of anti-inflammatory agents decreases allergy signs and symptoms in both the early and late phase reactions. rx-10045 has been shown to be efficacious in multiple pre-clinical dry eye disease models and in a pre-clinical model of allergic conjunctivitis. the objective of this clinical study is to assess the safety and efficacy of rx-10045 ophthalmic solution for the treatment of the signs and symptoms of allergic conjunctivitis induced in the conjunctival allergen challenge model of allergic conjunctivitis at 15 minutes and 8 hours after medication instillation. it is anticipated that rx-10045 has therapeutic potential for the treatment of allergic conjunctivitis and an acceptable risk-benefit profile.

Eligibility criteria:
inclusion criteria: subjects must: 1. have a positive history of ocular allergies 2. have a positive bilateral conjunctival allergen challenge (cac) reaction exclusion criteria: subjects must not: 1. have known contraindications or sensitivities to study medication or its components 2. have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters 3. use a disallowed medication during the period indicated prior to the enrollment or during the study 4. be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
efficacy and safety of levamlodipine besylate compared to amlodipine maleate in patients with essential hypertension

Conditions: Essential Hypertension

Summary: this study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or 5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential hypertension.


Eligibility criteria:
inclusion criteria: * male or female outpatients, 18-75 years * patients with mild to moderate essential hypertension (defined as mean bp of 2 visits ≥140mm/90mmhg, and \< 180mm/110mmhg) * written informed consent exclusion criteria: * patients with secondary hypertension * patients with severe hypertension * have to take other drugs that can influence blood pressure during the study * allergic to dhp calcium antagonists * evidence of congestive heart failure, unstable angina or severe arrhythmia * renal or hepatic dysfunction * women who are taking contraceptive pills or are likely to be pregnant * participate in other clinical trials within 3 months prior to this study

Keywords: essential hypertension levamlodipine besylate amlodipine maleate
study of peripherally inserted central catheter (picc)-related infections in a tropical area

Conditions: Catheterization; Peripheral; Infection

Summary: septi-picc study aims at assessing incidence of peripherally inserted central catheter (picc)-related infections among patients managed in the university hospital of la reunion for picc setting.

septi-picc is a prospective single-center study of infections related to piccs setting at the south tertiary site of the university hospital of la reunion over one year with a follow-up of 6 months per patient. all the complications such as thromboembolic, are collected during the follow-up. it is planned a convenience sample of 400 patients over 18 years of age, except pregnant women.

Eligibility criteria:
inclusion criteria: * all patients managed for a picc setting in the tertiary care hospital exclusion criteria: * known pregnancy * minor

Keywords: peripherally inserted central catheter infections radiology
efficacy of hypnoanalgesia by a radiologist technologist in children with cutaneous angioma treated with sclerosis in interventional radiology

Conditions: Angioma

Summary: this study highlights the global management of the various components of outpatient pain by hypnoanalgesia (pain management by hypnosis) in radiopediatrics. indeed, pain is induced by sclerosis of cutaneous angiomas in interventional radiology. it is managed by meopa (an equimolar mixture of oxygen nitrous oxide) or by general anesthesia. for four years, the medical electroradiology technologist of the mother and child hospital (hfme) of the hospices civils de lyon offer patients in addition a pain management by hypnoanalgesia. the investigator propose a multicenter open randomized study comparing two pain management strategies, in children aged 7 to 18 years treated for cutaneous angioma by sclerosis in interventional radiology at the hfme. the two strategies studied are: hypnoanalgesia and meopa (the reference strategy). the main objective is to evaluate the efficacy of hypnoanalgesia compared to the standard of care of pain, which is the use of meopa, in the treatment of sclerosis of cutaneous angioma in pediatric interventional radiology.


Eligibility criteria:
inclusion criteria: * child requiring a first treatment with sclerosis cutaneous angioma whose location allows treatment in interventional radiology room, * child from 7 to 18 years old on the day of treatment, * free and informed consent of the child and his parents (or legal representative), * patient affiliated to a social security scheme exclusion criteria: * child under tutorship or guardianship, * child suffering from severe psychotic disorders or under psychotropic drug treatment, * child who has already had angioma sclerosis in the interventional radiology room. indeed, the child can remember a previous support and have a priori, positive or negative, on the new support (memory bias), * child not speaking french, * deaf child or hearing impaired not allowing easy listening

Keywords: hypnoanalgesia cutaneous angioma sclerosis treatment
trial of indomethacin prophylaxis in preterm infants (tipp)

Conditions: Infant, Very Low Birth Weight; Infant, Premature; Ductus Arteriosus, Patent

Summary: this trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999 grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy or developmental problems at 18 to 22 months of age.

prophylactic indomethacin reduces patent ductus arteriosus (pda) and intraventricular hemorrhage in very low birth weight infants. however, the effects of early indomethacin on long-term neurodevelopment remain uncertain. there is also insufficient evidence to rule out serious adverse effects, such as increases in the risk of necrotizing enterocolitis (nec) and retinopathy of prematurity (rop). the aim of this trial was to determine if prophylactic administration of indomethacin improves survival without neurosensory impairments in extremely-low-birth-weight infants. infants (n=1202) with birthweights 500 to 999 grams were randomized between 2 and 6 hours after birth to receive either intravenous indomethacin (0.1 mg/kg) or equal volumes of normal saline placebo, daily for 3 days. the primary outcomes at a corrected age of 18 months was a composite of death, cerebral palsy, cognitive delay, deafness, or blindness. secondary long-term outcomes were hydrocephalus necessitating the placement of a shunt, seizure disorder, and microcephaly. secondary short-term outcomes were patent ductus arteriosus, pulmonary hemorrhage, chronic lung disease, cranial ultrasonographic abnormalities, nectrotizing enterocolitis and retinopathy. infants were evaluated in follow-up at 18-22 months corrected age.

Eligibility criteria:
inclusion criteria: * birth weight 500 to 999 grams; * postnatal age greater than 2 hours; exclusion criteria: * unable to administer study drug within 6 hours of birth; * structural heart disease and/or renal disease; * dysmorphic features or congenital abnormalities; * tocolytic therapy with indomethacin or other prostaglandin inhibitor within 72 hours prior to delivery; * overt clinical bleeding from more than one site; * platelet count less than 50 x 109/l; * hydrops; * not considered viable

Keywords: chronic lung disease indocin indomethacin infants, very low birth weight intraventricular hemorrhage necrotizing enterocolitis patent ductus arteriosus pulmonary hemorrhage
transfusion requirements in critically ill oncologic patient

Conditions: Anemia

Summary: blood transfusion in critical ill patients has been associated to several complications and worse outcome. particularly in oncologic patients, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due impairment of cellular immunity. although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic patients. there are no prospective studies comparing outcomes between restrictive or liberal blood transfusion strategy in oncologic critical patients. this study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic critical patients - liberal or restrictive.

blood transfusion is commonly performed in critically ill patients, particularly in oncologic patients. however, there are many studies reporting adverse effects of this intervention and final data on benefits are not available. there are no prospective studies in oncologic patients regarding red blood cell transfusions requirements. there are observational and experimental studies suggesting worse outcomes including higher rates of infection and other clinical complications, maybe higher cancer recurrence, in patients submitted to red blood transfusion. hemoglobin levels around 9 g/dl are usually recommended although not based in evidence . the investigators purpose is to prospectively evaluate two strategies of transfusion in 400 patients with cancer admitted to intensive care unit for severe clinical condition: a liberal strategy - patients receive blood transfusion when hemoglobin is lower than 9 g/dl since the admission to icu until icu discharge; a restrictive strategy - patients receive blood transfusion only when hemoglobin is lower than 7 g/dl. clinical outcomes, costs and quality of life will be compared.

Eligibility criteria:
inclusion criteria: * adults patients with cancer admitted to icu due to severe clinical condition and * septic shock diagnosis and * solid neoplasm and * written informed consent exclusion criteria: * age less than 18 years or * leukemia or myelodysplastic syndrome or * hematologic neoplasm or * palliative treatment or * renal chronic failure in renal replacement therapy or * karnofsky status \< 50 or * previous thrombocytopenia (platelet number lower than 50.000/mm3) or * previous known coagulopathy or * life-threatening bleeding or * documented wish against transfusion or * patients who refused participation in the study

Keywords: strategies of transfusion red blood cells liberal restrictive oncologic critically ill patients
divit study diet and vitamin supplementation in patients with a neuroendocrine tumor

Conditions: Neuroendocrine Tumor

Summary: this study aims to investigate if the proportion of neuroendocrine tumor (net) patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet, effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. the measurements, will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). furthermore at t=18 a semi-qualitative interview will be performed.

objective: this study aims to investigate if the proportion of net patients with normal vitamin values can be increased, with vitamin suppletion and a personalized diet. methods: this is a single center 18-week open-label, non-comparative, single-arm, intervention study. after inclusion and the first measurements, adult patients with metastasized or irresectable net will continue with four weeks of standard treatment. after these four weeks participants with vitamin values below normal will get vitamin suppletion for each deficient vitamin and all participants will get the dietary intervention during 14 weeks. effects of the intervention will be evaluated by quantitative analysis of blood and urine and questionnaires. the measurements, including; baseline characteristics, quantitative analysis of blood and urine and questionnaires will be performed at baseline (t=0), after 4 weeks (t=4) and after 18 weeks at end of study (t=18). furthermore at t=18 a semi-qualitative interview will be performed.

Eligibility criteria:
inclusion criteria: * adult patients aged ≥ 18 years * net-patients with serotonin producing or non-serotonin producing tumors, with gastro-intestinal, pancreatic, bronchopulmonary or unknown primary tumor site and with metastasized or irresectable disease * ability to comprehend dutch (both reading and writing). * written informed consent provided. * use of somatostatin analogue for \> 6 months. exclusion criteria: * estimated life expectancy less than 6 months. * patients who have a history of another primary malignancy, except for radical and adequately treated malignancies from which the patient has been disease free for ≥ 1 year. * major abdominal surgery during study period. * patients already participated in the divit-pilot study * known hypersensitivity of (components of) somatostatin analogue

Keywords: neuroendocrine tumor vitamin diet