Kornimate/medical-research-clean huggingface dataset:
single-agent erlotinib in patients previously treated with oral etoposide in protocol osi-774-205

Conditions: Ependymoma

Summary: participants that were assigned to the oral etoposide treatment arm in protocol osi-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide were allowed to participate in this study to assess the safety profile of single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.

the protocol-specified futility criteria were met at the second interim analysis dated 15 aug 2012 for osi-774-205. per the data monitoring committee's recommendation and fda's agreement, the enrollment of patients in that study and study osi-774-206 was permanently closed.

Eligibility criteria:
inclusion criteria: * patients must have been enrolled in osi-774-205, been randomized to oral etoposide and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide * performance status: lansky ≥ 50% for patients ≤ 10 years of age or younger or karnofsky ≥ 50% for patients greater than 10 years of age * patients must have recovered from any acute toxicity to any prior anti-cancer treatment * total bilirubin ≤ 1.5 x upper limit of normal (uln) for age, serum glutamic pyruvic transaminase (sgpt) alt ≤ 3 x uln * serum creatinine based on age or creatinine clearance/glomerular filtration rate (gfr) ≥ 70 ml/min/m2 * patients must be neurologically stable for at least 7 days before registration * patients, both males and females, with reproductive potential must agree to practice effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study drug therapy * patients must be able to take erlotinib orally exclusion criteria: * taking strong/moderate cyp3a4 or cyp1a2 inhibitors/inducers ≤ 14 days before registration * have received any other chemotherapy or immunotherapy to treat ependymoma after discontinuation from osi-774-205 * taking proton pump inhibitors ≤ 14 days before registration * participating in another investigational drug trial while on study * pregnant or breast-feeding

Keywords: pediatric ependymoma ependymoma tarceva erlotinib
efficacy of higher dose enteral vitamin d supplementation in preterm 28 - 34 weeks of gestational age

Conditions: Vitamin D Supplementation

Summary: the goal of this clinical trial is to learn about the effective dosage of enteral vitamin d supplementation in preterm infants with gestational age fom 28 to 34 weeks. the main questions it aims to answer is: - does higher dose of enteral vitamin d supplementation (800iu/day) increase vitamin d level better than standard recommended dose (400iu/day) to achieve sufficient level of vitamin d? participants will: * take the enteral vitamin d supplementation every fay for 28 days * have their blood level of vitamin d examined before and after supplementation for 28 days

the study conducted in 2 hospitals in jakarta region, rscm and rsud koja. preterm with 28 to 34 weeks of gestational age and fulfill the inclusion criteria will be enrolled in the study after parents signed the informed consent. blood sample will be collected to get the baseline of vitamin d serum. the study subject will be given enteral vitamin d supplementation for 28 days (4 weeks). the dosage of vitamin d is randomized with block randomized in sealed envelope. subjects then will be followed up to 28 days of supplementation. after 28 days of supplementation, the subjects' blood will be collected to get the vitamin d serum level. data taken will be analyzed using ibm statistical product and service solutions (spss).

Eligibility criteria:
inclusion criteria: * neonates with gestational age 28-34 weeks * tolerated enteral feedings more than 30ml/kg exclusion criteria: * infants with major congenital anomaly * infants with gastrointestinal obstruction * infants with congenital renal failure * infants with cholestassis

Keywords: vitamin d supplementation in preterm
evaluation of a new medical device al539 in patients with obstructive apneas sleep syndrome

Conditions: Obstructive Sleep Apnea Syndrome

Summary: continuous positive airway pressure (cpap) is the standard treatment in patients with obstructive sleep apnea syndrome (osas). the goal of the study is to evaluate cpap treatment duration recorded by the al539 during attended in-hospital polysomnography in patients with obstructive sleep apnea syndrome.

patients are patients with sleep apnea predominantly obstructive, with cpap for at least 2 months, and requiring in-hospital night polygraphic record control. the medical device was developed to determine: * the duration of use of cpap by the patient, * the persistence of any respiratory abnormalities during treatment. these two parameters are used to ensure that treatment is done correctly. the use of the al539 is expected to improve the home-monitoring of ventilation with cpap.

Eligibility criteria:
inclusion criteria: * sleep apnea predominantly obstructive * cpap for at least 2 months and requiring in-hospital night polygraphic record * written informed consent form * able to read and write in french exclusion criteria: * ventilator with two levels of pressure * cpap breathing circuit non-compatible with the al539 * chronic respiratory disease * psychotropic treatment which may influence the respiratory parameters * acute rhinitis or acute nasopharyngitis * moderate or severe chronic heart failure * cheyne-stokes respiration * body mass index (bmi) \> 40 * pregnant woman or woman of childbearing potential with a positive urinary pregnancy test * uncontrolled progressive disease * psychiatric disorders or regular user of drugs * participation in any interventional clinical trial within 30 days prior to selection

Keywords: continuous positive airway pressure (cpap) al539 home-monitoring
prospective and obsevational study of total hip prothesis: hype stem

Conditions: Hip Arthropathy

Summary: the purpose of this study is to validate the performance and the safety of the hype (serf) prothesis in compliance with the 93/42/eec directive and in relation to the recommendations of the meddev 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of clinical data in order to verify the performance claimed for medical devices .


Eligibility criteria:
inclusion criteria: * man or women * degenerative or inflammatory hip pathology requiring a total hip replacement * primary or secondary osteoarthritis * advanced joint destruction resulting from rhumatoid arthritis or traumatic arthritis * fracture or avascular necrosis * sub-capital fracture and displaced transcervical as well as for bone defects stages i to iib of paprosky * traumatic joint destruction * following previous intervention, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, total arthroplasty exclusion criteria: * people with diminished mental faculties * known current pregnancy * breast-feeding * neurological disorders or other pathologies that may influence locomotion * septic antecedent on hip to operate * patient requiring a bone graft

Keywords: total hip prothesis
vancomycin powder combined with autogenous bone graft as a prevention for post-operative infection for spine surgery

Conditions: Spinal Fusion; Spinal Stenosis; Spondylolisthesis

Summary: deep surgical site infection (dssi) is one of the most challenging complications for spinal surgeons and can lead to a poor clinical outcome. this ambispective study was designed to examine the effect of vancomycin powder mixed with autogenous bone graft and bone substitute on preventing deep surgical site infection (dssi) in degenerative lumbar fusion surgeries as well as any interference with bony fusion.


Eligibility criteria:
inclusion criteria: * patients who have instrumented spine fusion surgery due to failed conservative treatment (bed rest, medication, rehabilitation programs) for 3 to 6 months * patients who are willing to sign the surgical permit after the surgeon explains all surgical procedures along with the surgical risks * patients who fully understand the surgical procedures as well as the surgical risks and are willing to sign the surgical permit and the inform consent * patients who agree one more blood withdrawal after operation exclusion criteria: * patients who agree to accept the spine surgery but do not agree to sign the inform consent * patients who have allergic reaction to vancomycin

Keywords: deep surgical site infection vancomycin-impregnated bone graft spine surgery degenerative lumbar disorder
trial to evaluate safety, pd & pk of iv study drug, qn-302, in pts w/ advanced or metastatic solid tumors

Conditions: Solid Tumor

Summary: goal: learn about qn-302 in patients with solid tumors (metastatic, or advanced cancer). main questions: * what does the study drug do to human body (pharmacodynamics \[='pd'\]) * what does the body do to study drug (how processed in body (pharmacokinetics \[='pk'\]) - safety study drug by intravenous infusion ('iv') once weekly for 3 weeks every 4-week 'cycle.' study treatment continues as long as patient and their study doctor agree that study treatment is in the best interest of the patient.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed locally advanced or metastatic solid carcinomas, who have had tumor progression after receiving all standard of care therapies or for which there is no approved therapy 2. evaluable or measurable disease by recist 1.1 exclusion criteria: -
effect of monitoring of step number on diabetes

Conditions: Type 2 Diabetes Mellitus; Physical Activity

Summary: in this study, investigators measured the number of steps, blood pressure, blood glucose, and weight in daily life through the smartphone personal health record application for patients with type 2 diabetes. the efficacy of text message intervention, which encourages an increase in the number of steps per week for 12 weeks, on an increase in the number of daily steps and changes in glucose levels, weight, and blood pressure will be investigated. also, the durability of intervention will be checked after 12 weeks of intervention ending.

this clinical study is a single institution, randomized, prospective study and monitors the average daily number of steps per week using a smartphone personal health record application developed by samsung medical center for patients with type 2 diabetes. the study subjects were divided into five groups such as 1) basal activity (\<2500 steps/day), 2) limited activity (2500-4999 steps/day), 3) low activity (5000-7499 steps/day), 4) somewhat active (7500-9999 steps/day), 5) active (10000-12499 steps/day), 6) highly active (≥12500 steps/day)according to the average number of steps per day. during the 12-week period, the intervention group receives the text messages that encourage step-by-step increments every week, and the control group does not receive text messages. the effect of 12-week step monitoring and education on the change in daily step count will be analyzed. also, the effect of change in daily step count on glucose level, body weight, and blood pressure will be studied.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes aged 20-69 years * patients with a hba1c of less than 8.5% measured during screening (may be replaced by a test value within 3 months of screening visit ) * patients who have not been prescribed diabetic medication for the past 4 weeks or who have taken more than one oral hypoglycemic agent for more than 12 weeks at a certain dose * bmi ≥ 23 kg/m2 * available for use samsung galaxy s4 or later android smartphone and wireless internet * patients who voluntarily agreed to participate in this clinical study exclusion criteria: * diabetes other than type 2 diabetes, including type 1 diabetes, gestational diabetes * patients who are taking insulin or glp-1 agonist other than oral hypoglycemic agent * patients with uncontrolled chronic liver disease * patients with acute kidney injury * patients with psychological disorder * patients who are taking weight lowering agent * patients with alcohol or drug addiction within the last 3 * patients who are taking systemic steroid * patients who are breastfeeding or pregnant * patients who did not voluntarily agree to the study * patients who are unsuitable for participation in clinical research

Keywords: type 2 diabetes mellitus physical activity personal health record intervention
the effect of arginine on classic galactosemia

Conditions: Classic Galactosemia

Summary: rationale: classic galactosemia is a rare inherited metabolic disease that presents in neonatal patients with a life-threatening multi-organ toxic syndrome. although the current standard of care - a galactose-restricted diet - quickly relieves the severe neonatal clinical picture, it fails to prevent brain and gonadal sequelae. there is a need for new therapeutic strategies. as arginine is an amino acid that is therapeutically widely used with no side effects described, we propose to use it in a pilot-clinical study. we aim to evaluate the effects of arginine in classic galactosemia patients, in order to determine its potential therapeutic role in this disease. objective: to evaluate the possible effect of arginine on the whole body galactose oxidative capacity in classic galactosemia patients. study design: interventional pilot-clinical study with pre-post single arm design. study population: we aim to include 5 classic galactosemia adult patients homozygous for the p.q188r mutation. intervention: all participants will receive arginine in the form of asparten ® (arginine aspartate) during 1 month, by oral administration. the main study parameter is whole body galactose galactose oxidative capacity.


Eligibility criteria:
inclusion criteria: * classic galactosemia patient homozygous for the p.q188r mutation, diagnosed by galt enzyme activity assay and galt gene mutation analysis * eighteen years of age or older * capable of giving informed consent exclusion criteria: * urea cycle disorders (assessed by post prandial amino acid profile in blood) * increased level of plasma uric acid * patients experiencing acute illness of classic galactosemia * pregnant women (or considering getting pregnant) or breastfeeding women
the neurodevelopmental and behavioral phenotyping screening protocol

Conditions: Neurologic Disorders; Autism; Neurodegenerative Disease; Neurobehavioral Manifestation

Summary: the purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at nih.

the purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorders. the evaluations may be used to determine if the participant meets criteria for participation in research protocols at the national institute of mental health (nimh) and other collaborative investigations. since the entry criteria for these protocols vary, the screening evaluations will also vary. behavioral evaluations will also be done through this protocol for individuals participating in irb-approved protocols being conducted by collaborating scientists at nih. the evaluations might include: a psychiatric interview; a diagnostic interview; developmental and/or cognitive testing; ratings of other psychiatric symptoms; neuropsychological testing; a medical history; a physical exam; blood; and a request for medical records. parents of minors will be interviewed.

Eligibility criteria:
* inclusion criteria: * subjects must be at least 6 weeks of age. * subjects or their parents must be competent to comprehend the purpose of the screening process and to provide written informed consent. parents/guardians will sign the consent form, and both minors and adults (depending on results of capacity assessment) will be asked to assent only if it is determined that they understand their role in the study. * subjects must be willing to undergo an evaluation which may include a psychiatric interview; and medical, neurological, and laboratory examinations (as appropriate, such as renal and liver function tests, serum electrolytes, urinalysis, blood levels of psychotropic drugs, and urine drug screen for the presence of psychoactive drugs and drugs of abuse, as determined on a subject-to-subject basis). exclusion criteria: -lack of appropriate consent: for minor patients, consent must be obtained from all legal guardians/caretakers, including both parents in separated or divorced families where there is shared legal custody of the child. in such cases, both parents must consent to the child s participation in this protocol.

Keywords: developmental delay pediatric pervasive developmental disorder early development healthy control subjects autism spectrum disorders healthy volunteer hv
treatment plan to provide expanded access to stiripentol for patients with dravet syndrome

Conditions: Dravet Syndrome

Summary: expanded access to stiripentol for patients with dravet syndrome.

this is a treatment plan, and therefore patients will be monitored according to clinical standard of care.

Eligibility criteria:
inclusion criteria: * 6 months and older * diagnosis of dravet syndrome with intractable seizures exclusion criteria: * hypersensitivity to the active substance or to any of the excipients * past history of psychoses in the form of episodes of delirium * impaired hepatic and/or renal function, defined as creatinine \>2 and/or transaminase \>4xuln
does vitamin d supplementation enhance resolution of inflammation after community-acquired pneumonia?

Conditions: Pneumonia

Summary: previous research has shown that people who have been hospitalised for pneumonia are more likely to die of conditions such as heart attacks, stroke and cancer in the weeks to months after their illness. this risk is linked to raised levels of inflammation. laboratory research shows that vitamin d can help to clear inflammation. vitamin d deficiency is very common in the united kingdom. the investigators are conducting this study to find out if taking vitamin d can hasten long-term recovery from pneumonia by reducing inflammation.


Eligibility criteria:
inclusion criteria: 1. adults ≥50 years of age 2. vitamin d deficiency at entry, defined as a serum total 25(oh)d concentration \<50 nmol/l 3. admission to hospital with an acute illness (≤21 days) consistent with community-acquired pneumonia - at least one symptom of a lower respiratory tract infection (cough, sputum production, dyspnoea, wheeze, chest discomfort or pain, fever) and new infiltrate on chest radiograph 4. adequate mental capacity to give informed consent for participation in the study and gives written informed consent exclusion criteria: 1. currently taking any vitamin d supplementation 2. known hiv infection, other condition causing immunosuppression, current immunosuppressive therapy or systemic corticosteroids 3. known malignancy not in remission for \>3 years or terminal illness with prognosis \<1year 4. history of smoking within the previous 1 year 5. known or suspected diagnosis of chronic obstructive pulmonary disease (copd) 6. previous hospitalisation within 10 days of admission 7. aspiration pneumonia diagnosed by the clinical team 8. known diagnosis of cystic fibrosis, bronchiectasis or interstitial lung disease at screening 9. complications of pneumonia such as empyema or lung abscess at entry 10. recent acute coronary syndrome within the previous 1 month 11. long term oxygen therapy, chronic mechanical ventilation dependency or other contraindication to sputum induction 12. serum corrected calcium concentration \>2.65 mmol/l at entry 13. chronic kidney disease stage 4-5 (estimated glomerular filtration rate \<30ml/min) on an existing blood sample from the current hospital admission 14. known clinical diagnosis of liver failure 15. known or suspected diagnosis of active pulmonary tuberculosis 16. known diagnosis of primary hyperparathyroidism 17. known diagnosis of sarcoidosis 18. known diagnosis of nephrolithiasis 19. taking carbamazepine, phenytoin, phenobarbital, primidone, cardiac glycosides or benzothiadiazines with concomitant calcium supplementation at entry 20. known allergy to vitamin d or its excipients 21. currently taking part in another research study

Keywords: convalescence inflammation resolution vitamin d
effect of pioglitazone on portal and systemic hemodynamics in patients with advanced cirrhosis

Conditions: Cirrhosis; Ascites; Portal Hypertension

Summary: the purpose of this study is to investigate the response to pioglitazone on the hepatic venous pressure gradient and peripheral vascular responsiveness to vasoconstrictors in patients with advanced (child´s grade b or c) cirrhosis.

cirrhotic liver disease is associated with portal hypertension including elevated portal pressure as well as hyperdynamic circulation and low peripheral vascular resistance. endothelial nitric (no) release is impaired in liver microvasculature, upregulation of enos activity in the cirrhotic liver may constitute a new strategy to correct the increased hepatic vascular tone in these patients. in contrary to this impaired endothelium-dependent relaxation (endothelial dysfunction) and no deficiency in the cirrhotic liver, systemic and splanchnic circulation of cirrhotic patients is characterized by increased vascular tone and hyporesponsiveness to vasoconstrictors. in addition to increasing insulin sensitivity, thiazolidinediones, like pioglitazone decrease oxidative stress and inflammation and improve endothelial function. in a randomized controlled, parallel group double-blind study 20 patients with advanced (child´s grade b or c) liver cirrhosis will receive pioglitazone or placebo for nine days. portal hemodynamics and forearm blood flow response will be measured at baseline and after pioglitazone/placebo to investigate the effect of pioglitazone in these group of patients.

Eligibility criteria:
inclusion criteria: * cirrhosis, grade b or c (child-pugh score) exclusion criteria: * history of hypersensitivity to the trial drugs and contrast agent or to drugs with a similar chemical structure * treatment with vasoactive or non-steroidal anti-inflammatory drugs or systemic antibiotics one week before the study * exclusion criteria for hepatic hemodynamic investigation * cardiac, renal or respiratory failure * previous surgical or transjugular intrahepatic portosystemic shunt * insulin-dependent diabetes

Keywords: cirrhosis oxidative stress pioglitazone