Kornimate/medical-research-clean huggingface dataset:
mri in high-grade glioma patients undergoing chemoradiation

Conditions: High Grade Glioma

Summary: the purpose of this research study is to see if investigators can predict how brain functioning changes after radiation treatment based on pet scans and blood tests. most participants experience at least mild decreases in their memory or attention after radiation therapy. investigators hope that pet scans, lumbar puncture, and blood tests might help investigators predict who might have larger changes in their brain function after radiation.

primary objective: to determine the feasibility of interim pet-mri in high-grade glioma patients undergoing chemoradiation by quantifying the proportion of high-grade glioma patients who are alive at 4 months post-radiation treatment and who have completed two pet scans and abbreviated cognitive testing pre-radiation treatment and at 4 months post radiation treatment. secondary objectives * to determine by machine learning if early changes on fdg-pet correlate with cognitive decline after radiation treatment. cognitive impairment will be defined as a 1 standard deviation decline on any test. * to determine if baseline serum or cerebrospinal fluid markers or the change from baseline to 1-month are associated with patients with cognitive decline at 4-months after radiation treatment (defined as a 1 standard deviation decline on any test) compared to those without decline.

Eligibility criteria:
inclusion criteria: * pathologically confirmed diagnosis of high grade glioma (grade iii or iv) or who grade ii glioma, idh wildtype (molecular glioblastoma multiforme \[gbm\]). * ≥18 years of age. * ecog performance status of 0 to 3 * anticipated to receive 6 weeks of chemoradiation exclusion criteria: * does not speak or read english * unable to participate in cognitive testing due to aphasia or other severe cognitive impairment as determined by the pi, or dr. cummings or her designee. * unable to give informed consent * past medical history of any kind of dementia or diagnosed with mild cognitive impairment prior to diagnosis with their brain tumor * unable to safely fast for 8 hours prior to bloodwork or 6 hours prior to pet scan * currently taking cognition-enhancing medications including: * donepezil * memantine * armodafinil * methylphenidate * pregnant or nursing mothers. * patients taking blood thinners will be excluded from the optional lumbar puncture only, they are eligible for participation in the main study-provided they meet inclusion/exclusion criteria
clinical pharmacology of chf 1535 50/6 ug next dpi in children 5-11 years old

Conditions: Asthma in Children

Summary: this is a pharmacokinetic comparison of chf 1535 50/6 next dpi versus the free combination of beclomethasone dpi and formoterol dpi in children (5 to 11 years old) of a formulation already approved in adults.

pharmacokinetic study in asthmatic children 5 to 11 years old treated with either a fixed combination of beclomethasone 50 ug/unit dose plus formoterol fumarate 6 ug/unit dose via the next dpi dry powder inhaler or a free combination of beclomethasone 100 ug dpi and formoterol 6 ug dpi according to a cross-over design.

Eligibility criteria:
inclusion criteria: 1. male/female children aged 5 -11y 2. written informed consent obtained by parents/legal representative (according to local regulation) and by the minor (age and local regulation permitting). 3. children with stable asthma 4. children with asthma on regular treatment with ics or using short-acting inhaled beta2-agonists as reliever to control asthma symptoms 5. forced expiratory volume in one second (fev1) \> 70% of predicted values (% pred) after withholding beta2-agonists treatment for a minimum of 4 h prior to each study treatment. 6. a cooperative attitude and ability to be trained about the proper use of dpi and compliant to study procedures. exclusion criteria: 1. past or present diagnoses of cardiovascular, renal or liver disease 2. known hypersensitivity to the active treatments 3. exacerbation of asthma symptoms within the previous 4 weeks 4. inability to perform the required breathing technique and blood sampling 5. hospitalization due to exacerbation of asthma within 1 month prior to screening (visit 1) 6. lower respiratory tract infection within 1 month prior to screening (visit 1) 7. disease (other than asthma) which might influence the outcome of the study 8. obesity, i.e. \> 97% weight percentile by local standards

Keywords: asthma children next dpi laba ics inhalation
treatment choice and outcomes for esrd: evidence from the first year of a nationwide randomized evaluation

Conditions: End Stage Renal Disease

Summary: the investigators plan to analyze the first year of a nationwide randomized-controlled trial of end stage renal disease (esrd) treatment choice model (etc). this mandatory-participation program was designed by the centers for medicare and medicaid services and randomization was conducted at the hospital referral region (hrr) level. 95 hrrs were assigned to the treatment group beginning in january 2021. the investigators will study the impact of this program in the first year on treatment modality choice for esrd and explore heterogeneity in impact across patients and providers.


Eligibility criteria:
inclusion criteria: * all medicare-certified esrd facilities and medicare-enrolled managing clinicians located in hrrs in the united states are required to participate. * patient is receiving dialysis or other services for esrd * patient is new to dialysis, defined as not having received dialysis for at least 12 months prior to their first observed dialysis claim * patient is enrolled in medicare part b exclusion criteria: * hrrs in us territories * hrrs with 20% or more zip codes in maryland (excluded from randomization) * facilities and clinicians with fewer than 11 attributed beneficiaries * patient is receiving dialysis only for an acute kidney injury * patient is younger than 66 years of age before initiating dialysis * patient received a kidney transplant within 12 months prior to the start of dialysis and does not have a kidney transplant failure code * patient is enrolled in medicare advantage, a cost plan, or other medicare managed care plan * patient resides outside of the us or in one of the us territories * patient has elected hospice * patient has a diagnosis of dementia at any point in the first 90 days or the preceding 12 months before initiating dialysis as identified using centers for medicare and medicaid services hierarchical condition categories (cms-hcc) * patient is residing in or receiving dialysis in a skilled nursing facility (snf)

Keywords: hemodialysis peritoneal dialysis
tms for complex regional pain syndrome

Conditions: Complex Regional Pain Syndromes

Summary: the aim of the current study is to assess the efficacy of tms in the treatment of complex regional pain syndrome (crps). it is hypothesized that participants who receive tms (group 1) relative to sham treatment (group 2) once daily for two days will demonstrate a greater improvement in crps-related pain and other associated symptomology (i.e., cognitive, emotional and physical) compared to baseline. participants will be followed until they reach their baseline for two consecutive weeks to assess safety and duration of symptom alleviation.


Eligibility criteria:
inclusion criteria: * age 18-70 * diagnosis of crps (complex regional pain syndrome) for at least 3 months * average pain level reported on numerical rating scale meets entry criteria * ability to perform the experimental task and procedures. exclusion criteria: * mri contraindication (metal implants or devices, claustrophobia) * tms contraindication (eg metal implant or devices near the site of stimulation) * history of epilepsy * history of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher. * neurologic illness that would interfere with brain integrity * current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher. * currently pregnant or planning to become pregnant. * on going legal action or disability claim.

Keywords: tms, crps, sham
community based multiple risk factors intervention strategy

Conditions: Hypertension; Diabetes Mellitus; Hyperlipidemia

Summary: randomized controlled trial of corfis programme. the study objectives are as follows: 1. to determine the efficacy of a community based multiple risk factors interventional strategy (corfis) for a treatment period of 6 months in patients on treatment for ht, dm or hl. 2. the intervention shall consist of a purpose design and systematically organized disease management program that employ multi-faceted interventions incorporating various specific measures to maximize both clinician (as investigator) adherence with treatment guideline and patient adherence with treatment.

it should be obvious to all that we urgently need to improve the management of the various risk factors for cardiovascular (cvd) and chronic kidney diseases (ckd); the 3 most important of which are hypertension (ht), diabetes mellitus (dm), hyperlipidaemias (hl). it is not just that these are highly prevalent in our community, they are also poorly managed and controlled, with resulting highly costly and adverse health impact on our population. it should also be equally obvious that we need a better approach to manage these risk factors in our community. there have been considerable advances in our understanding of these risk factors and in our knowledge of the variety of approaches to achieving control of these risk factors including the role of self-monitoring and self-management education, medical nutrition therapy, physical activity, psychological counseling, and various drug therapy options. this study is a multi-center, open label, parallel group randomized trial designed to demonstrate the effectiveness of a community based multiple risk factors interventional strategy (corfis). 750 patients on treatment for ht, dm or hl from 75 general practices (gps) who meet inclusion/exclusion criteria will be enrolled into the trial. among the 75 selected gps, 50 of them will be randomly allocated to corfis and 25 to routine care. after initial screening, patients will attend clinic for baseline examination. study prescribed visits for efficacy and safety assessments will occur monthly for 6 months. hence there will be a total of 7 visits.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed by participating gp to have hypertension and/or diabetes mellitus and/or hyperlipidaemias, and currently on drug treatment for one or more of these conditions 2. patients age 18 years and above. 3. written informed consent obtained from patients. exclusion criteria: 1. pregnant or nursing women. 2. history of unstable angina, acute myocardial infarction or coronary revascularisation procedure in the preceding 6 months. 3. clinically significant valvular heart disease. 4. overt heart failure or history of heart failure in the preceding 6 months 5. stroke in the preceding 6 months. 6. serum creatinine more than 150umol/l in the preceding 6 months.

Keywords: hypertension diabetes mellitus hyperlipidaemia primary care community care multiple risk factors interventional strategies
hiv candidate vaccine, alvac-hiv-1, administration in hiv-negative adults

Conditions: HIV Infections; HIV Seronegativity

Summary: the purpose of this study is to determine the best way to administer the candidate hiv vaccine, alvac hiv-1 (vcp205).

healthy adult volunteers are assigned randomly to either a vaccine or placebo group. injections are received either intramuscularly, intradermally, or by delivery under the skin of the volunteer's own white blood cells which have had dendritic cell reinfusion. volunteers are vaccinated at 0, 1, 3, and 6 month time points. volunteers are closely monitored for 1 hour after vaccination and keep a diary of symptoms for 1 week post-immunization. volunteers undergo leukopheresis at the start of the study and after the last vaccination at walter reed army medical center. volunteers receive compensation benefits.

Eligibility criteria:
inclusion criteria volunteers may be eligible for this study if they: * are legal us residents. * are healthy adults from 18 to 55 years of age. exclusion criteria volunteers will not be eligible for this study if they: * are hiv-positive. * are at highest risk for hiv infection. * are pregnant or breast-feeding. * are allergic to eggs or neomycin. * use certain prescription medications.

Keywords: injections, intramuscular injections, intradermal injections, subcutaneous hiv-1 aids vaccines dendritic cells hiv seronegativity genes, env genes, pol genes, gag transfection hiv preventive vaccine
safety and equivalence of a generic ciclopirox olamine cream compared to the reference ciclopirox cream 0.77% for the treatment of tinea pedis

Conditions: Tinea Pedis

Summary: the objectives of this study were to demonstrate comparable safety and efficacy of ciclopirox olamine cream (test product) and ciclopirox cream 0.77% (reference product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.


Eligibility criteria:
inclusion criteria: * male or female at least 10 years of age, and otherwise healthy * clinically and mycologically confirmed diagnosis of symptomatic tinea pedis * in good health with no clinically significant disease that might have interfered with study evaluations * study participant or legal guardian was willing and able to read and sign an irb approved icf, which included agreement to comply with all study requirements as indicated in the protocol. for subjects 10 to 17 years of age, an assent form for minors was completed. exclusion criteria: * history of hypersensitivity or allergy to ciclopirox * had any skin condition that would interfere with the diagnosis or assessment of tinea pedis * had a history of dermatophyte infecton unresponsive to antifungal treatment * had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study * had any condition or used any medication that, in the opinion of the investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk * was unwilling to sign the informed consent * female who was pregnant or lactating

Keywords: tinea pedis ciclopirox olamine
magnesium sulphate in perinatal asphyxia

Conditions: Perinatal Asphyxia , Moderate to Severe HIE

Summary: magnesium sulphate has been shown to be neuroprotective. the investigators hypothesize that magnesium sulphate infusion given to babies with perinatal asphyxia should improve outcome in the immediate neonatal period.

magnesium sulphate has a neuroprotective potential as has been shown by many studied in pregnant ladies with eclampsia where it helped neonates also and in mothers with preterm labour where the incidence of cerebral palsy was less. we designed a randomised controlled trial on 40 neonates with severe perinatal asphyxia to see whether it helps in the short term outcome of these neonates.

Eligibility criteria:
inclusion criteria: * babies eligible for the study were: 1. term or post term 2. less than 6 hours of age and had 3. severe perinatal asphyxia as manifested by any three of the following criteria. * history of fetal distress (late deceleration, loss of beat to beat variability, fetal bradycardia, meconium stained amniotic fluid) * need for immediate neonatal ventilation with bag and mask or through endotracheal intubation for 2 minutes or more after delivery * a 5-minute apgar score of \< 6 * base deficit 15 meq/l in cord blood or admission arterial or cord blood ph 4.moderate to severe encephalopathy exclusion criteria: * patients with severe iugr * any condition unrelated to asphyxia * maternal prenatal magnesium administration * metabolic disorder * chromosomal anomalies; and * congenital malformations were excluded from the study

Keywords: asphyxia perinatal magnesium sulphate
is carotid intima-media thickness affected by a1c variability?

Conditions: Type 2 Diabetes; A1C Variability

Summary: this study was conducted to evaluate the effect of a1c variability on the progression of carotid artery intima-media thickness in type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * type ii * fluoroscopy in carotid once a year during 2 years exclusion criteria: * type 1 diabetes * history or clinical evidence of coronary artery disease or cerebral or peripheral vascular disease * the presence of albuminuria (defined as 24 hour urine albumin excretion ≥ 30 mg) * renal dysfunction (defined as creatinine blood level ≥ 2.0 mg/dl) * hepatic dysfunction (defined as alanine aminotransferase and/or aspartate aminotransferase blood level ≥ 3 × upper normal limit) * smoking within the past 3 months prior to commencement of the study * use of any medication likely to alter imt such as calcium channel blocker, thiazolidinedione, antiplatelet agent (clopidogrel, cilostazol) * use of glucocorticoid * pregnancy * severe concomitant disease such as cancer * infection * cushing's syndrome * acromegaly, or any other disorder likely to alter glycemia * primary hypercholesterolemia * hypothyroidism or hyperthyroidism * use of any hormonal drugs * alcoholism or drug abuse
pain felt during removal of the products from infant's skin used in nasogastric tube fixation

Conditions: Pain, Acute

Summary: the present study was planned to evaluate the pain of 4-6 weeks infants felt during removal of the adhesive products from newborn's skin used in the fixation of nasogastric tube in neonatal and infant units. the hypothesis of the study is "water-based barrier tape is more effective to reduce pain than hydrocolloid barrier tape.

the study was planned as randomized controlled and experimental design to compare the efficiency of three different methods reducing pain during removal adhesive products for 4-6 weeks infants. the universe of the study consisted of 4-6 weeks infants in neonatal and infants clinics of giresun women's and children's hospital between the dates of july-september 2021. power analysis was performed through g\*power (v3.1.7) programme in order to determine the number of the sample. at the beginning of the study, a reference study (kemer, 2020) was used for sample calculation. the effect size was calculated as d=0.561 regarding the assessment of skin condition scores and 120 participants in total should be included in the study as 40 participants for each groups in order to obtain 80% power in the level of α=0.05. block randomization technique is applied in the study as a randomization method. "as for data collection "infant description form" and "neonatal infant pain scale" was used. the scale was filled by two independent observer via double-blind method.

Eligibility criteria:
inclusion criteria: * all the 4-6 weeks infants including interventional process and without any skin diseases exclusion criteria: * the infants receiving treatment without any interventional process * those having a skin disease * those infants having peripherally inserted central venous catheter

Keywords: infant pain adhesives fixation
optimized duration of clopidogrel therapy following treatment with the endeavor - optimize trial

Conditions: Coronary Artery Disease

Summary: prospective, multicenter, randomized (two-arm 1:1), non-inferiority clinical evaluation comparing 2 regimes of dual antiplatelet therapy (dapt) with aspirin + clopidogrel following percutaneous coronary intervention (pci) with endeavor zotarolimus eluting stent (zes) to evaluate the impact of different regimes of dapt on clinical outcomes in minimally selected patients from the "real-world" clinical practice receiving the endeavor zes for the treatment of coronary artery lesions. patients undergoing percutaneous treatment with the endeavor zes will be randomized in a 1:1 ratio to 2 regimens of dapt including oral clopidogrel 75mg/day for 3 months versus 12 months.


Eligibility criteria:
inclusion criteria: 1. patients \>18 years of age, 2. clinical indication for pci with stent implantation of at least one angiographically documented coronary artery lesion, 3. agreement to undergo all protocol clinical follow-ups. 4 - presence of at least one obstruction \>50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (≥2.50mm), with coronary anatomy suitable for percutaneous treatment with implantation of the endeavor zes. exclusion criteria: 1. st-elevation acute mi presenting for primary or rescue pci; 2. des in-stent restenosis; 3. pci with bare metal stents \<6 months prior to index procedure; 4. previous treatment with any des; 5. scheduled elective surgery within 12 months post index procedure; 6. contra-indication, intolerance, or known hypersensibility to aspirin and/or clopidogrel; 7. known illness with life expectancy \<36 months; and impossibility to comply with all protocol follow-ups. 8. target lesion(s) located in saphenous vein grafts, 9. coronary anatomy unsuitable for percutaneous treatment with implantation of the endeavor zes.

Keywords: coronary, disease
effect of lyon and schroth techniques on adolescent i̇diopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: today, it is known that the conservative treatment of scoliosis is gaining importance. in addition, no study has been found comparing the efficacy of two important conservative treatment methods, the schroth and lyon method, in adolescent idiopathic scoliosis. accordingly, this study was conducted to compare the effectiveness of schroth and lyon exercises in individuals with ais.


Eligibility criteria:
inclusion criteria: * participants were between ages 10-18, * volunteered for the study, * diagnosed with adolescent idiopathic scoliosis, * cobb angle between 10-30 degrees, * 0-3 risser sign, * sanders classification 0-4 , * lenke curve type 1 exclusion criteria: * participants who other type of scoliosis * previous spinal surgery * exercise contraindications * rheumatological disease * another neuromuscular problem were excluded from the study.