Kornimate/medical-research-clean huggingface dataset:
pegloticase for the reduction of uric acid in patients with tumor lysis syndrome

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Tumor Lysis Syndrome

Summary: this trial studies the effect of pegloticase in reducing uric acid levels in patients with hyperuricemia (high blood levels of uric acid) caused by tumor lysis syndrome. tumor lysis syndrome occurs when the breakdown products of cancer cells, such as uric acid, enter the blood stream. high levels of uric acid in blood may cause kidney damage and reduce kidney function. the goal of this trial is to learn if pegloticase may lower uric acid levels in blood when given to cancer patients with hyperuricemia caused by tumor lysis syndrome.

primary objective: i. to collect preliminary data on the effectiveness of a single dose of pegloticase in lowering serum uric acid levels to less than 6.0 mg/dl within 24 hours in patients with hyperuricemia in the setting of tumor lysis syndrome. secondary objectives: i. to assess the effect of pegloticase on renal function in patients with hyperuricemia in the setting of tumor lysis syndrome as measured by changes in serum creatinine/estimated glomerular filtration rate (egfr) and urine output. ii. to estimate the rate of renal replacement therapy initiation for acute kidney injury secondary to tumor lysis syndrome among patients treated with pegloticase. outline: patients receive pegloticase intravenously (iv) over 120 minutes. patients whose serum uric acid does not drop below 6 mg/dl within 24 hours receive a second dose of pegloticase iv over 120 minutes on day 2. patients whose serum uric acid does not drop below 6 mg/dl after two doses of pegloticase receive standard of care rasburicase iv once daily (qd) for 5 days.

Eligibility criteria:
inclusion criteria: for inclusion in the study, patients should fulfill the following criteria: 1. signed informed consent prior to any study specific procedures (patient or caregiver) 2. male or female 18 years of age or older 3. in the investigator's opinion, expected survival of at least 1 month 4. deemed stable by the investigator 5. serum uric acid ≥ 6 mg/dl 6. risk for tumor lysis syndrome based on the md anderson tls risk score exclusion criteria: patients will be ineligible for study enrollment if any of the following exclusion criteria are fulfilled: 1. inability or refusal to give informed consent (patient or caregiver) 2. subject unwilling to take study medication 3. known allergy to uricase 4. pregnant 5. breastfeeding 6. known glucose-6-phosphate dehydrogenase (g6pd) deficiency 7. transfusion in last 7 days (as this interferes with g6pd test), with the exception of platelet transfusions. 8. has received rasburicase during current admission.(can be considered i24 hours after last rasburicase administered, current or previous admission)
sleep quality during covid-19 containment in children whether or not usually followed in child psychiatry

Conditions: Sleep Disturbance

Summary: the purpose of this study is to determine whether sleep disturbances in children aged 7 to 12 during covid-19 containment are more prevalent in children who received routine psychiatric care before containment compared to children who don't have any psychiatric care.

the coronavirus epidemic reached france in january 2020 and the who declared the covid-19 outbreak was a pandemic on 11 march 2020. in response to this pandemic the french government announced national containment starting on 17 march 2020. some recent studies suggest that a containment duration of more than 10 days and an extension beyond the originally announced duration would increase the psychological impact of it. sleep is a vital function that contributes to the proper neurophysiological and psychological development of human beings especially children. sleep disorders can have a major impact on a child's behavior, mood, cognitive performance and metabolism. sleep disorders are often associated with depression, anxiety and cognitive changes. chronic sleep disorders are also risk factors for mental illness to our knowledge, no study targeting the quality of sleep in children who usually receive psychiatric care is underway or has been published. it is essential to ask what the quality of sleep in children with a psychiatric diagnosis who suddenly lose their bearings and their usual daily routine (school, therapeutic groups, day hospitals, etc.) after several weeks of containment. this study is designed to assess different parameters in the 2 groups of children (healthy volunteers and child with follow-up in child psychiatry) : * the sleep quality, * the depression level, * the anxiety level, * if socio-demographic factors have an influence on sleep disorders, * if there is a correlation between children's sleep quality, and anxiety level / sleep quality in their parents.

Eligibility criteria:
inclusion criteria: * child aged 7 to 11 years and 11 months included on the first day of containment in france on 17 march 2020 * child receiving care at the cmp of cergy-le-haut (medico-psychological center) on the 2020 active patient population (at least one appointment with a child psychiatrist, a psychologist, a psychomotor therapist or a speech therapist or in a therapeutic group between january and march 2020) or * child not receiving any psychiatric care and having no siblings (half-brother, half-sister) followed in child psychiatry * no parental opposition exclusion criteria: * poor french reading comprehension by parents * objection of the child * child under guardianship, curatorship or foster care * child not on containment : child cared for outside his home everyday (in school and hospital daycare for example).

Keywords: children sleep disturbance scale for children containment covid-19 anxiety psychological distress sleep wake disorders child psychiatry mental health
analytical validation of the abioscope device with the in vitro device (ivd) capsule psp test: comparison of psp values measured with venous whole blood and those measured with arterial whole blood

Conditions: Pancreatic Stone Protein; Device

Summary: abionic society has developed a novel point-of-care (poc) platform, the abioscope, and an in vitro diagnostic kit for the quantification of the pancreatic stone protein (psp) to be analyzed specifically with the abioscope® device. the psp is a host protein biomarker produced by the pancreas in response to a sepsis-related organ dysfunction and has shown a great potential in the early identification of septic patients this test is intended to be used to aid in the early recognition of sepsis. the test is extremely easy to use and has a total turnaround time of approximately 8 minutes. this test uses only 50 microliters of k2/k3-edta venous anticoagulated whole blood. results are quantitative (ng/ml). the product is for investigational use only in the us and bears ce-marking. it is commercially available in selected european and non-european countries. the test has also been clinically validated in a multicentric, prospective, observational study performed (ab-psp-001, clinicaltrials.gov identifier nct03474809). the main goal of this study is to evaluate the analytical performances components of this product in a point-of-care environment, in particular the sample type comparability between arterial and venous whole blood.


Eligibility criteria:
inclusion criteria: 1. provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis; 2. male or female, 18 years of age or older; 3. patient admitted to hospital 4. need for venous and arterial blood samples as part of standard of care 5. covered by a social security scheme. exclusion criteria: 1. subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure; 2. subject under juridical protection.

Keywords: pancreatic stone protein
safety and efficacy study of lb80380 in the treatment-naive patients of chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of the study is to investigate the safety and the antiviral activity of two doses of lb80380 for 48 weeks in treatment-naive patients with chronic hepatitis b infection compared to entecavir 0.5 mg.

lb80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type hbv. lb80380 is undergoing clinical development by lg life sciences for use in the treatment of chronic hbv infection. in this study, the treatment period is 48-week with 24-week of follow-up period.

Eligibility criteria:
inclusion criteria: * female or male, 18 to 65 years of age, inclusive * chronic hepatitis b * not treated with anti-viral therapeutics including interferon or pegylated interferons for more than 12 weeks before screening * not treated with anti-viral therapeutics including interferon or pegylated interferons 6 months within screening * compensated chronic hepatitis b * hbeag positive or hbeag negative * elevated serum alt level (1.2-10 x uln, inclusive) exclusion criteria: * co-infection with hepatitis c or d virus (hcv or hdv) or hiv * decompensated liver disease * creatinine clearance (calculated by cockroft-gault formula) less than 50 ml/min * screening alpha-fetoprotein (afp) value greater than or equal to 50 ng/ml, and a follow-up ultrasonography performed prior to baseline shows findings indicative of hcc * treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry. * pregnancy or breast-feeding * patient is currently abusing alcohol or illicit drugs * significant systemic illnesses other than liver diseases * presence of other causes of liver disease * a history of organ transplantation presence of anti-hbs at screening

Keywords: chronic hepatitis b lb80380 treatment-naive entecavir
phase 1/2 study of vascular disrupting agent npi-2358 + docetaxel in patients with advanced non-small cell lung cancer

Conditions: Cancer

Summary: this is a clinical trial examining the vascular disrupting agent npi-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (nsclc). the formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues.

this is a clinical trial examining the vascular disrupting agent npi-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (nsclc). the formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues. there are indications of advantages in combining vascular disrupting agents with standard agents in the treatment of advanced non-small cell lung cancer (nsclc).

Eligibility criteria:
inclusion criteria: * male and females ≥ 18 years of age * ecog performance status ≤ 1 * pathologically or histologically confirmed advanced non-small cell lung cancer (unresectable stage iiib or iv) that has progressed after treatment with at least one chemotherapy regimen; measurable disease is not required for enrollment into this trial * all adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to grade ≤ 2 * signed informed consent exclusion criteria: * administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames * significant cardiac history * prior treatment with tumor vascular disruptive agents * seizure disorder * brain metastases * active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy * known infection with human immunodeficiency virus (hiv), or active hepatitis a, b, or c * patients with a prior hypersensitivity reaction to product components * pregnant or breast-feeding women. * concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix * unwilling or unable to comply with procedures required in this protocol

Keywords: non small cell lung
the hemostatic and hemodynamic effects of adrenaline during endoscopic sinus surgery

Conditions: Chronic Sinusitis

Summary: obtaining adequate hemostasis is crucial during endoscopic sinus surgery. submucosal injection of local anaesthetic containing adrenaline has frequently been used to improve surgical milieu. however, injection of adrenaline has potential side effects including tachycardia, hypertension as well as inducing arrhythmia. the aim of this randomized clinical trial is to assess the hemodynamic and hemostatic effects of two different concentrations of adrenaline in local anaesthetic used during endoscopic sinus surgery.


Eligibility criteria:
inclusion criteria: * recurrent acute sinusitis, chronic sinusitis, or nasal polyposis exclusion criteria: * bleeding disorders, under age of 18, history of cardiac disease or on antihypertensive medications

Keywords: endoscopic sinus surgery
first line chemotherapy for advanced cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to determine whether albumine-bounded paclitaxel plus s-1 are effective in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma.

this phase ii study was designed to evaluate the efficacy and safety of albumin-bounded paclitaxel combined with s-1 as first-line chemotherapy for inoperable and /or metastatic gastric or gastroesophageal junction cancer.primary endpoint was overall response rate.

Eligibility criteria:
inclusion criteria: * inoperable locally advanced, recurrent, and/or metastatic adenocarcinoma of the stomach or gastro-esophageal junction * adult patients \>=18 years of age * performance status- eastern cooperative oncology group (ecog) 0-2; * at least have one measurable disease(according to recist) * adequate bone marrow,renal and liver function exclusion criteria: * previous chemotherapy for advanced/metastatic disease * lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome
evaluation of the prenatal trip assistance pilot project

Conditions: Pregnancy Preterm; Infant Death

Summary: the prenatal trip assistance project is a study comparing two methods of delivering transportation assistance to pregnant women living in communities with high rates of infant mortality. franklin county, ohio, home of the state's capital of columbus, has one of the highest rates of infant mortality in the u.s. at 8.2 per 1,000 live births.there have been many advances in "smart" applications in transportation over the past 10 years. however, despite the fact that the vast majority of impoverished women have a mobile phone, the transportation providers currently used by the medicaid managed care plans are low tech with no mobile alerts or two-way communication with the woman. the purpose of the proposed study is to examine the preliminary efficacy of providing expanded and "smart" transportation services to increase communications, reliability, and customer satisfaction and reduce adverse pregnancy outcomes among women whose children are at high risk of infant mortality. the investigators aim to enroll and randomize 500 eligible pregnant women to either on-demand services or usual transportation services as provided by their medicaid managed care organization. the primary outcome for the proposed trial will be overall satisfaction with transportation services as assessed by the final study questionnaire (i.e., two months after delivery or miscarriage) and secondary outcome measures will include: adequacy of prenatal care, preterm birth and infant mortality.


Eligibility criteria:
inclusion criteria: * willing to consent to communication by phone, text, and email * access to a telephone (mobile or landline), tablet or computer * pregnant \& \<32 weeks of gestation * last menstrual period on or before 2/9/2020 or due by november 15, 2020 * at least 18 years old * enrolled in one of two medicaid managed care organizations * residence in franklin county, ohio * ambulatory * english speaking exclusion criteria: * no plans to move out of franklin county prior to delivery * able to read, understand, and communicate in english * woman has not been previously enrolled in this study * race/ethnicity stratum is not full * willing to meet staff to be interviewed

Keywords: transportation; prenatal care
genetic testing of cerebrospinal fluid to diagnose and monitor glioblastoma

Conditions: Glioblastoma

Summary: the goal of this study is to determine the utility of cerebrospinal fluid (csf) cell-free dna (cfdna) as a prognostic biomarker in glioblastoma (gbm).


Eligibility criteria:
inclusion criteria: cohort a * participants must be able to understand and be willing to sign a written informed consent document * age ≥ 18 years * mri with contrast-enhancing lesion concerning for high-grade glioma in absence of known systemic malignancy * clinical consensus of presumed diagnosis of high grade glioma between (1) neuroradiology (2) neurosurgery; and (3) principal investigator * no prior tumor directed therapy * planned radiation therapy for glioblastoma * patients must be willing and able to tolerate mri scans and/or ct scans w/ contrast * patients must be willing to consent to msk irb#12-245 cohort b * participants must be able to understand and be willing to sign a written informed consent document * age ≥ 18 years * histologic confirmed glioblastoma (who grade iv), idh wild type per ihc * no prior tumor-directed therapies except surgical resection or biopsy * patients who have gliadel wafers placed during upfront surgery are excluded * planned radiation therapy for glioblastoma * patients must be willing and able to tolerate mri scans and/or ct scans w/ contrast * patients must be willing to consent to msk irb#12-245 exclusion criteria: cohorts a and b * any case for which there is a medical contraindication or safety concern regarding a lumbar puncture under standard medical guidelines at msk * refusal to undergo serial lumbar punctures

Keywords: glioblastoma csf cfdna cerebrospinal fluid cell free dna memorial sloan kettering cancer center 23-058
intra-ductal confocal endomicroscopy for characterization of pancreas and bile duct tumor

Conditions: Pancreas Neoplasms; Bile Duct Diseases

Summary: the endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". this monocentric, non randomized and prospective study uses the intra-ductal confocal endomicroscopy for the characterization of pancreas and bile duct tumor.

primary objective: obtain a tissular characterization of a biliary or pancreatic stenosis with a confocal microscope which is in direct contact of the stenosis during the endoscopic retrograde cholangio-pancreatography (ercp). secondary objectives: * compare the result of this "optical biopsy" to a conventional biopsy. * tolerance

Eligibility criteria:
inclusion criteria: * patients aged from 18 to older * patient with an inflammatory or tumoral stenosis of bile duct or a solid or cystic tumor in the pancreas with a dilatation of the principal pancreatic canal. * signed consent non inclusion criteria: * patient who have no indication for an ercp * allergy to fluorescein * allergic rhinitis, asthma, eczema * pregnancy, breast feeding * patients with dialysis * patient with severe heart failure * patient with cirrhosis * hemostasis failure which can induce difficulties or contraindication for the biopsy during the conventional endoscopy

Keywords: pancreas neoplasms bile duct diseases cholangiopancreatography, endoscopic retrograde ercp
computer-based training in cognitive behavior therapy

Conditions: Cocaine Abuse

Summary: the computer-based training program (cbt for cbt) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.

in this behavioral trial 120 methadone maintained cocaine abusing individuals will be randomly assigned to either treatment as usual in a community-based clinic or treatment as usual plus 8 hours of access to the 'cbt for cbt' computer program over a period of 8 weeks. primary outcomes will be retention in treatment and reduction in cocaine use (percent days abstinent, confirmed by urine toxicology screens). the patients' ability to demonstrate coping skills through a computerized role-play evaluation will be a secondary outcome. a six-month follow-up will assess durability and/or delayed emergence of effects.

Eligibility criteria:
inclusion criteria: * 18 years and older * methadone maintained for at least 3 months * meet current dsm-iv criteria for cocaine use disorder * fluent in english or at least a6th grade reading level * can commit to at least 8 weeks of treatment and willing to be randomized to treatment exclusion criteria: * untreated bipolar or schizophrenic disorder * current legal case pending (pending incarceration during 8 weeks of study)

Keywords: cognitive behavior therapy computer assisted instruction drug abuse therapy educational resource design and development
nomograms to precisely predict conditional risk of recurrence for patients with laryngeal cancer

Conditions: Recurrent Laryngeal Cancer

Summary: advanced laryngeal squamous cell carcinoma (scc) remains a highly morbid and fatal disease despite aggressive interventions. mortality is high in this cohort: laryngeal cancer affects over 13 000 patients in the united states, with over 3500 deaths annually.the results of the veterans affairs cooperative studies program laryngeal cancer trial and subsequent studies demonstrated similar overall survival (os) rates for organ preservation protocols involving radiotherapy (rt) or chemoradiotherapy (crt) when compared to surgery, with the benefit of preserving the larynx in a large majority of patients. as such, the use of rt or crt has become the predominant initial intervention for patients with laryngeal scc.6 however, the prognosis of recurrent and persistent laryngeal scc is particularly dire.in this study, we sought to identify preoperative predictors of survival for patients with recurrent or persistent laryngeal scc in order to set patient expectations and address modifiable risk factors. identification of predictors of survival may also identify patients who could benefit from novel therapeutic agents in a neo/adjuvant fashion. herein,we examine a cohort of patients with recurrent or persistent laryngeal scc after definitive rt/crt who has undergone total laryngectomy in order to identify potential preoperative predictors of clinical outcomes.

demographic, clinical, and survival data were abstracted. death was verified via medical records and the social security death index. primary outcome measures were os (time from salvage laryngectomy to death from any cause), disease-specific survival (dss; time from salvage laryngectomy to death from recurrent/persistent laryngeal scc), and dfs (time from salvage laryngectomy to laryngeal scc recurrence)

Eligibility criteria:
inclusion criteria: patients with a diagnosis of laryngeal squamous cell carcinoma exclusion criteria: multiple primarry malignant neo-plasms

Keywords: risk of recurrence nomograms laryngeal cancer