Kornimate/medical-research-clean huggingface dataset:
second window indocyanine green for all nervous system tumors

Conditions: Nervous System Tumor

Summary: the study is being conducted to determine if a same-day, low-dose intravenous (into a vein) injection of indocyanine green (icg) (fda-approved dye) being detected by using an imaging system can be a useful tool in identifying and differentiating tumor tissue from normal tissues.


Eligibility criteria:
inclusion criteria: 1. adult patients 18 years of age and older 2. patients presenting with a nervous system tumor presumed to be resectable and at risk for local recurrence on pre-operative assessment 3. good operative candidates, as determined by the treating physician and multidisciplinary team 4. subjects capable of giving informed consent exclusion criteria: 1. pregnant women, as determined by urinary or serum beta hcg within 48 hours of surgery 2. subjects with a history of iodide allergies 3. vulnerable patient populations 4. patients unable to participate in the consent process 5. patients with history of uncontrolled htn (requiring er admission or ≥ 3 bp medications)
study to assess pxl065 in subjects with adrenomyeloneuropathy (amn) form of x-linked adrenoleukodystrophy (x-ald or ald)

Conditions: ALD (Adrenoleukodystrophy)

Summary: a randomized open-label phase 2a study to assess the pharmacokinetics and pharmacodynamic parameters of pxl065 after 12 weeks of treatment in male subjects with adrenomyeloneuropathy (amn).

a randomized open-label phase 2a study to assess the pharmacokinetics and pharmacodynamic parameters of pxl065 after 12 weeks of treatment in male subjects with adrenomyeloneuropathy (amn). there will be a total of 3 study periods. * screening period of a maximum of 4 weeks prior to the open-label treatment period (baseline visit - v2). this period can be exceptionally extended for 2 weeks * open-label treatment period of 12 weeks * follow-up period of 2 weeks after the last intake of the treatment (v5-end of treatment visit (eot)). during the treatment period, very long chain fatty acids (vlcfa) will be assessed every 4 weeks, to evaluate the kinetics of the pxl065 effect. neurofilament light (nfl) will be assessed after 8 and 12 weeks of treatment, and other exploratory biomarkers after 12 weeks of treatment. a follow up period will allow continued monitoring the subjects' safety and evaluation of the kinetics of the 2 main biomarkers (vlcfa and nfl) at 2 weeks after the last intake of the treatment.

Eligibility criteria:
inclusion criteria: * male subjects with either a confirmed diagnosis of amn by genetic testing (mutation in the atp binding cassette subfamily d (abcd1 gene)) or a family history of x-linked adrenoleukodystrophy (ald) together with an elevation in vlcfa obtained from overnight fasting plasma sample at screening visit (v1). * age: ≥ 18 to ≤ 65 years at informed consent signature. * normal brain magnetic resonance imaging (mri) or brain mri showing non-specific abnormalities that can be observed in amn subjects without signs of cerebral form of ald (c-ald). mri must be performed within 6 months prior to v2. if there is no available brain mri within this period, a brain mri must be performed before v2 exclusion criteria: * any progressive neurological disease other than amn. * arrested or progressing c-ald as defined by cerebral lesions (except for non-specific abnormalities that can be observed in amn subjects). * prior receipt of an allogeneic hematopoietic stem cell transplant or gene therapy
implementation of standing desks at school

Conditions: Health Behavior

Summary: since sedentary time is related to various health outcomes and is already highly prevalent in childhood and adolescence, effective strategies are needed to tackle this health problem. children and adolescents spend the majority of the day in a classroom while sitting at a desk. therefore, the classroom is an important setting for implementing specific strategies to reduce sedentary time. one of the strategies that gained more attention during the past years is replacing traditional desks and chairs with standing desks. this project evaluates the implementation of standing desks in primary and secondary schools via a clustered randomized controlled trial using an intervention and control condition. effects on sedentary time during in class, sedentary activities during leisure time, breaks in sedentary time, and related determinants (secondary outcomes) are evaluated. next to effect evaluation, it is also equally important to evaluate how teachers and pupils perceive this change in the classroom environment. both groups need to be positive in order to obtain the adoption and sustainability. therefore, focus groups with pupils and interviews with teachers are conducted, with a specific focus on the perceived barriers. moreover, the process evaluation is conducted quantitatively as well by using questionnaires in pupils and teachers. the project results will lead to recommendations on how to broadly implement standing desks into primary and secondary schools.


Eligibility criteria:
inclusion criteria: * healthy pupils of primary schools (5th grade) and secondary schools (10th grade)

Keywords: sedentary behavior
comparison of ifa and liaison® for diagnosis of early disseminated lyme borreliosis in children, younger than 18 years

Conditions: Lyme Disease

Summary: the aim of this study is to compare two different serological tests, ifa and liaison, for detection of borrelia burgdorferi sensu lato igm and igg antibiodies in children with early disseminated lyme borreliosis.

slovenia is highly endemic region for lyme borreliosis (lb). lb is a tick - borne multisystem infectious disease caused by borrelia burgdorferi sensu lato. solitary erythema migrans (sem) is a typical clinical manifestation of early localized lb and microbiological confirmation of borrelial infection is not required for diagnosis. clinical manifestations of early disseminated lb (multiple erythema migrans (mem), peripheral facial palsy and meningitis) are not characteristic enough to enable a reliable diagnosis, indicating the need for laboratory demonstration of borrelial infection which is mainly accomplished with serological tests. for detection of borrelial antibodies several methods are used, such as immunofluorescent assay (ifa), enzyme immunoassay (eia) and immunoblots. serological tests are not standardized and have limited sensitivity and specificity. the aim of this study is to specify and compare the sensitivity of ifa and liaison serological tests in early disseminated lb in children in slovenia. the secondary aim is to determine the influence of early antibiotic treatment of early disseminated lb on serological results in children with lb in slovenia and to compare the serological results in children who are treated with antibiotics immediately and those who are treated later in the course of the study.

Eligibility criteria:
children younger than 18 years with early disseminated lyme disease: * multiple erythema migrans * peripheral facial nerve palsy * lymphocytic meningitis

Keywords: lyme disease ifa liaison children slovenia
first-line gemcitabine chemotherapy with our without sunitinib in advanced or metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: primary objective: to evaluate whether the addition of sunitinib prolongates the progression-free survival (pfs) in patients with advanced pancreatic cancer receiving first-line gemcitabine chemotherapy.


Eligibility criteria:
inclusion criteria: * patients who suffer from locally advanced or metastatic pancreatic cancer * patients with measurable disease (at least one uni-dimensionally measurable target lesion by ct-scan or mri) according to response evaluation criteria in solid tumors (recist). * ecog performance status 0 to 1 * signed written informed consent. * white blood cell count (wbc) \>= 3x10\^9/l with neutrophils \>= 1.5 x 10\^9/l, platelet count \>= 100x10\^9/l, hemoglobin \>= 5.6 mmol/l (9 g/dl). * total bilirubin \< 2 x upper limit of normal. * ast and alt \< 2.5 x upper limit of normal, or \< 5 x upper limit of normal in case of liver metastases. * serum creatinine \< 1.5 x upper limit of normal * normal ecg without qt prolongation exclusion criteria: * resectable pancreatic cancer * previous chemotherapy (for adjuvant or metastatic disease) * any investigational drug within the 30 days before inclusion. * prior use of sunitinib or other multitarget tyrosine kinase inhibitor * pregnancy (absence to be confirmed by beta-hcg test) or lactation period. * men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial. * clinically symptomatic brain or meningeal metastasis. (known or suspected) * cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin). * history of any of the following cardiac events within the past 6 months: myocardial infarction (including severe/unstable angina; coronary/peripheral artery bypass graft; symptomatic congestive heart failure (chf) \> nyha class ii; cerebrovascular accident or transient ischemic attack; pulmonary embolism * uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm hg despite the use of up to 3 anti-hypertensive drugs * acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea * previous malignancy (other than pancreatic cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor \[ta, tis and t1\]. * history of organ allograft * patients requiring long-term cortisone therapy * patients requiring oral anticoagulation treatment (such as marcoumar)

Keywords: cancer pancreatic cancer gemcitabine sunitinib phase 2
igfd registry: a patient registry for monitoring long-term safety and efficacy of increlex

Conditions: Primary Insulin-like Growth Factor-1 Deficiency

Summary: this project is a retrospective (beginning january 2006) and prospective patient registry program sponsored by ipsen (formerly tercica, inc.). in collaboration with participating health care practitioners, the patient registry program is an observational study monitoring the long-term safety of patients treated with increlex® (mecasermin \[rdna origin\] injection). the igfd (increlex® growth forum database) registry is intended primarily to monitor the safety and efficacy of increlex replacement therapy in children with growth failure.

the data collected for a patient will be those that exist in the patient's medical record as part of standard medical care. no additional patient procedures or activities are mandated by this study. the specific data to be collected at each visit and the schedule of data collection are listed in a schedule of assessments. the collection of safety events is considered essential to the registry. the website will provide the opportunity to report the occurrence of targeted adverse events (aes), other important events considered to be related to increlex administration and serious adverse events (saes).

Eligibility criteria:
inclusion criteria: * parents or legally authorized representatives must give signed informed consent before any registry-related activities are conducted. assent from the subject should also be obtained where appropriate. * patients receiving increlex® by a qualified practitioner may be enrolled exclusion criteria:

Keywords: growth hormone (gh) insensitivity syndrome insulin-like growth factor deficiency (igfd) short stature insulin-like growth factor (igf-1) growth
neutrophil-to lymphocyte and monocyte-to-lymphocyte ratios in exudative pleural effusion

Conditions: Effusion

Summary: exudative pleural effusion (epe) presents a diagnostic challenge, requiring accurate biomarkers to predict outcomes and guide treatment. the neutrophil-to-lymphocyte ratio (nlr) and monocyte-to-lymphocyte ratio (mlr) in pleural fluid are emerging as potential prognostic markers. we aimed to assess the diagnostic and prognostic utility of pleural fluid nlr and mlr in epe.

pleural fluid nlr and mlr are reliable biomarkers for diagnosing malignant pleural effusion and predicting poorer survival outcomes. these ratios may be useful in clinical practice, especially in resource-limited settings, to guide decision-making in the management of pleural effusions.

Eligibility criteria:
inclusion criteria: * adult patients aged 18-80 years with an epe diagnosis confirmed by thoracentesis. exclusion criteria: * exclusion criteria included patients with a history of recent surgery, corticosteroid use, or those with mixed effusion types.
peritoneal membrane dysfunction in peritoneal dialysis using metabolomics

Conditions: End Stage Renal Disease; Dialysis

Summary: ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis

ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis. identification of peritoneal membrane functional status changes over time, at the same patient (cohort study), by metabolomics, aiming in personalized medicine best practice. identification of peritoneal membrane functional status changes over time in immature infants' peritoneal membrane. identification of early and accurate markers of peritoneal membrane dysfunction when membrane status is possibly reversible that could predict peritoneal patients at risk for future loss of ultrafiltration and dialysis adequacy of small molecules examined today be pet, kt/v and cr/cl (when membrane status is not reversible). improve pd survival in infants and children.

Eligibility criteria:
inclusion criteria: * pediatric and adolescent patients on peritoneal dialysis * aged:1month -20 years exclusion criteria: -abdominal surgery

Keywords: children renal failure dialysis
safety & radiation distribution study of cotara® in patients with recurrent glioblastoma multiforme

Conditions: Recurrent Glioblastoma Multiforme

Summary: rationale: cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. this monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. cotara® thus literally destroys the tumor "from the inside out." this may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer. purpose: this trial is studying the safety and radiation distribution of cotara® in patients with recurrent glioblastoma multiforme.

objectives: primary * to confirm the dose limiting toxicities (dlt) and maximum tolerated dose (mtd) of 131i-chtnt-1/b mab (cotara®) when given as a single 25 hour interstitial infusion in patients with recurrent gbm * to characterize the biodistribution and radiation dosimetry of cotara® outline: this is an open-label, dose escalation study of cotara®. all patients will receive 3 mci of cotara® for biodistribution and radiation dosimetry purposes. in addition, patients will receive escalating therapeutic dose levels of cotara® for confirmation of the maximum tolerated dose (mtd). after completion of study treatment, patients are followed for a minimum of 12 weeks and until disease progression.

Eligibility criteria:
inclusion criteria: * patients with recurrent gbm * patients with a clinical target volume between 5 and 60 cc (inclusive) * patients of 18 years of age or older * karnofsky performance status ≥ 60 at screening * patients not on steroids or maintained on a stable corticosteroid regimen (± 4 mg) for at least 2 weeks prior to study entry exclusion criteria: * patients with infratentorial tumor(s), exophytic intra-ventricular tumor(s) or subependymal tumor spread extending greater than 2 cm * patients with diffuse disease * patients with known or suspected allergy to study medication or iodine * patients who received investigational agents within 30 days prior to baseline * patients who received surgical resection within 4 weeks from baseline * patients with known hiv or evidence of active hepatitis * patients who cannot undergo mri

Keywords: brain cancer cotara radioactive isotope monoclonal antibody radiation distribution
intravenous ketamine and postoperative pain following cesarean section.

Conditions: Postoperative Pain

Summary: the purpose of this study is to investigate the analgesic effect of low-dose intravenous ketamine in pregnant mothers undergoing cesarean section under bupivacaine spinal anesthesia.

* no premedication will be given, and patients will be monitored by electrocardiogram, non-invasive arterial blood pressure, and pulse oximetry when they entered the operating room. * 18 gauge iv cannula will be inserted and all patients will be preloaded with 10 ml/kg of lactate ringer over 20 min period. * all participants will have spinal anesthesia using bupivacaine. the dose of the drug, as well as the method of injection will be identical for all individuals; 10 mg (2 cc 0.5%), in the l4-l5 space using needle 25 g, midline, with the patient in a sitting position. * after administering bupivacaine, and prior to surgery the height of the sensory block will be assessed bilaterally (complete loss of sensation to ice) in a ascending fashion starting from t12 dermatome. * once adequate anesthesia to at least t6 dermatome will be achieved, the operation will be allowed to begin. when systolic blood pressure decrease to \< 90 mmhg, or 30% of the pre-anesthetic blood pressure, it will be corrected by administering 5 mg ephedrine. * patients will be asked to report any intraoperative pain using visual pain score(vps)of 0(no pain) 10(worst pain).

Eligibility criteria:
inclusion criteria: * eligible women asa class 1 and 2, are at term (≥37 week gestation), scheduled for elective cesarean section whose anesthetic plan is for spinal anesthesia with bupivacaine and intravenous pethidine and paracetamol for post operative analgesia. exclusion criteria: * • body mass index ≥40 kg/m2, * known allergy to any of the study medications, * contraindication to the spinal anesthesia, * history of substance abuse, * history of hallucinations, * chronic opioid therapy, * chronic pain.
a study of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with completely resected non-small cell lung cancer who have received adjuvant platinum-based chemotherapy

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the purpose of this study was to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (nsclc) following resection and adjuvant chemotherapy.

with protocol amendment 2, enrollment will be stopped. the primary objective of the study has been changed to a safety objective and no other analysis will be conducted

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 * histological or cytological diagnosis of stage iib, iiia, and select iiib nsclc of either non-squamous or squamous histology * participants must have had complete resection of nsclc * participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy * participants must have recovered adequately from surgery and from adjuvant chemotherapy * tumor cell pd-l1 expression at \>/= 1% * adequate hematologic and end-organ function. exclusion criteria: * any history of prior nsclc within the last 5 years * any evidence of residual disease or disease recurrence following surgical resection of nsclc, or during or following adjuvant chemotherapy * nsclc known to have mutation in the epidermal growth factor receptor (egfr) gene or an anaplastic lymphoma kinase (alk) fusion oncogene
usefulness of nasal continuous positive airway pressure (cpap) treatment in patients with a first ever stroke and sleep apnea syndrome

Conditions: Sleep Apnea; Stroke; Cardiovascular Disease

Summary: main aims: to analyze the efficacy of nasal cpap treatment in patients with ischemic first-ever stroke and sleep apnea syndrome (sas) in terms of: early neurological outcome, functional recovery, quality of life influence, stroke recurrence and survival. secondary aims: to evaluate the feasibility of the treatment in this type of patients at short and long time. design: clinical randomized case-control study. patients: younger than 75 years with a first-ever stroke with at least one of the following criteria: snoring, observed apnea, hypertension or ischemic cardiopathy. measurements: protocol to define subtype stroke and parenchymatous and vascular location; sleep questionnaire (including epworth sleepiness scale); respiratory polysomnography (rpsg). if rpsg shows an ahi \> 20, with predominant obstructive events, patients will be randomized in a control group (conventional treatment) and a treatment group (with nasal cpap). follow up for both groups at 1, 3, 12 and 24 months will include: early neurological outcome, body mass index (bmi), blood pressure (bp), functional recovery (barthel index/canadian scale), quality of life (sf36), recurrences, vital status. nasal cpap titration will be performed by means of an automatic system (autoset portable st). compliance will be recorded. if a negative rpsg is obtained (ahi \< 10) (no sas group) or with ahi \< 20 (mild sas) the usual treatment and the same follow up protocol will be established. statistics: the sample size is initially calculated in 10 patients for each group, considering this is part of a multicenter study including 8 centers. if no differences are found, depending on the statistical power the investigators will consider including more patients. the different groups will be compared for the analyzed variables with the corresponding tests.


Eligibility criteria:
inclusion criteria: * first ever stroke * any sleep apnea symptom * hypertension exclusion criteria: * aphasia * cognitive impairment * hypersomnolence
potente study: a study of early virological response in naive patients with chronic hepatitis c, genotype 2 or 3, treated with pegasys (peginterferon alfa-2a (40kd)) plus copegus (ribavirin).

Conditions: Hepatitis C, Chronic

Summary: this single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis c, genotype 2 or 3, treated with pegasys + copegus. eligible patients will be treated with pegasys 180 micrograms/week sc + copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. non-responders at week 4 will be entered into a separate protocol (mv21371) to receive pegasys + copegus for 24 or 48 weeks. the anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * positive serum hcv rna. exclusion criteria: * co-infection with hiv or hbv (patients with a positive hbsag); * previous treatment with interferon, or peginterferon and/or ribavirin; * severe hepatic dysfunction or decompensated cirrhosis of liver.