Kornimate/medical-research-clean huggingface dataset:
methylglyoxal evaluation in humans

Conditions: Type 2 Diabetes; Neuropathy, Painful; Chronic Low-back Pain; Lumbar Disc Herniation

Summary: the investigators will test the hypothesis that patients with low back pain associated with lumbar disc aberrancy will have elevated mgo-protein levels circulating in the blood that are comparable to patients with painful diabetic neuropathy.

this is a cross-sectional, non-interventional study conducted solely at ku medical center in which patients will be recruited and sorted based on the following status: 1) healthy, 2) painful diabetic neuropathy, 3) chronic low back pain as a result of non-operative lumbar aberrancy. once recruited, subjects will undergo a venous blood draw to measure mgo-protein levels, hba1c, blood glucose, nfl protein levels and glo1 activity. subjects will also complete questionnaires to better understand how mgo levels correlate with pain status.

Eligibility criteria:
inclusion criteria: * informed consent provided by the subject * able to read/speak english * type 2 diabetes * all healthy inclusion criteria and * blood glucose levels \> 126 mg/dl * diagnosed with neuropathy or experience painful numbness or tingling in their hands or feet * low back pain * all healthy inclusion criteria and * chronic (persistent pain lasting longer than 3 months) low back pain as a direct result of non-operative lumbar disc aberrancy (disc herniation, protrusion, or extrusion) * aberrancy occurring within 12 months of pre-screening exclusion criteria: * prisoner * current clinically significant cardiac or neurological disease * diagnosis of ibs, osteoarthritis, fibromyalgia, complex regional pain syndrome (crps), postherpetic neuralgia * lumbar surgery due to disc aberrancy * therapeutic spinal injections within the last 3 months (steroid, ablations, etc.) * chronic use of steroids or non * steroidal anti-inflammatory drugs (nsaids) within 3 months of pre-screen * past or present use of spinal cord stimulators
forel's field electrical stimulation for lennox-gastaut syndrome

Conditions: Lennox Gastaut Syndrome

Summary: the primary objective of this research is to study the efficacy and safety of deep brain stimulation (dbs) of forel's field h as adjunctive therapy for alleviating symptoms in lennox-gastaut syndrome.

this project aims to include 5 participants, and evaluate the effectiveness and safety of forel's field h stimulation in patients with lennox-gastaut syndrome through a prospective, interventional, unblinded, single-arm clinical trial. it is expected to provide new therapeutic options for patients with lennox-gastaut syndrome with alternative treatment options.

Eligibility criteria:
inclusion criteria: * participants are between the ages of 14 -35 years of age. * patients must be clinically evaluated as having lennox-gastaut syndrome. * persistence of disabling seizures at least 5 times per months or greater. * after comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not satisfactory. * informed consent signed. exclusion criteria: * psychogenic non-epileptic seizures within 12 months; * presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). note: vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit; * risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications; * iq \< 55 or severe cognitive dysfunction, unable to complete the study; * diagnosed with a progressive neurological disorder (including progressive rasmussen's encephalitis, etc.); * diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders; * diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function; * pregnant, or planning to pregnant within 2 years; * participation in another clinical study within 3 months; * not suitable for enrollment as assessed by the multidisciplinary team of the center.

Keywords: deep brain stimulation lennox-gastaut syndrome forel's field h
a cohort study on biomarkers to predict the efficacy of biologics for chronic rhinosinusitis with nasal polyps

Conditions: Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); Biological Therapy; Biomarkers

Summary: recently, several biologic therapies have become available for treating chronic rhinosinusitis with nasal polyps (crswnp). however, not every patient responds to these treatments. this clinical trial aims to develop a non-invasive predictive model to help determine how effective il-4rα targeted monoclonal antibody therapy will be for individuals with crswnp.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years old. 2. with bilateral chronic rhinosinusitis with nasal polyposis. 3. nasal polyp score ≥4 (minimum score of 2 per nasal cavity) at baseline. 4. nasal congestion score ≥2 at baseline. 5. patients who have received systemic corticosteroids (scs) treatment within 2 years before screening, and/or have contraindications or intolerance to scs treatment, and/or received surgical for nasal polyps more than 6 months before screening. 6. have been using intranasal corticosteroids (incs) at a stable dose for at least 4 weeks before screening. 7. symptoms of nasal obstruction and additional symptoms such as loss of smell or rhinorrhea should be present for at least 4 weeks before screening. 8. good adherence. exclusion criteria: 1. not enough washing out period for prior biological therapy (within 10 weeks or 5 half-lives \[whichever is longer\] before baseline). 2. use of systemic immunosuppressants for inflammatory diseases or autoimmune diseases within 8 weeks or 5 half-lives before baseline (whichever is longer). 3. initiation of leukotriene receptor antagonist treatment, oral glucocorticoid treatment, or traditional chinese medicine treatment for chronic rhinosinusitis within 4 weeks before baseline. 4. subjects who have undergone surgery that changed the nasal structure and cannot be evaluated for nasal polyp score. 5. participants with a forced expiratory volume in 1 second (fev1) ≤50% of predicted normal during screening/run-in period. 6. hypersensitivity to mfns or anti-il-4r monoclonal antibodies or stapokibart components. 7. concomitant with other poorly controlled serious diseases or recurrent chronic diseases. 8. women who are pregnant, breastfeeding, or planning either during the study.
a pilot study of tdcs for mild to moderate alzhemier's disease

Conditions: Alzheimer's Disease

Summary: the primary objective of this preliminary study is to investigate whether the transcranial direct current stimulation (tdcs) improves the cognitive function in patients with alzheimer's disease

twenty patients were recruited and randomized to receive either real or sham-tdcs over the left (anode) and right (cathode) dorsolateral prefrontal cortex (dlpfc). their legally responsible caregivers were provided with mobile tdcs device, and were instructed to use it on the patients at home. 30-minute session of the stimulation were applied everyday in the morning for 12 weeks. the patients were evaluated at baseline, at week 6 and 12.

Eligibility criteria:
inclusion criteria: * subjects who have korean version of mini mental status examination score 10 to 24 * subjects who have svlt and rcft delayed recall test scores lower than 1.5sd * subjects who have had other cognitive impairments besides memory * subjects who have seoul-instrumental activities of daily living score (s-iadl) of 8 or more. * subjects who are only dementia of alzheimer's type * subjects who are right-handed * subjects who are able to read and write * both patient and legally responsible caregiver has provided informed consent * according to the latest mri result, periventricular white matter cap or band is less than 10mm, or the deep white matter hyper-intensity is less than 25 mm exclusion criteria: * subjects who have a history of stroke and seizures * subjects who have any illnesses that may disturb the patients completing the trials, including stroke, parkinson's disease, type 1 diabetes, uncontrollable high blood pressure, huntington's disease, cerebral palsy, liver failure, nephritis, encephalitis, meningitis, scleroma, seizures and a transient ischemic attack. * subjects who have a history of dsm-iv axis i disorders * subjects who have neurologic problems on physical examination that cause memory disturbances * subjects who have extremely sensitive skin * subjects who have suffered from the cancer in 3 years * subjects who have had a cerebrovascular neurosurgery in medical history * subjects who have dyspnea in sitting position * subjects who have problems with memory, language and problem-solving for 2 hours after the heart attack. * subjects who have a history of drug or alcohol abuse (in the past 5 years) * subjects who have a history of mental or emotional disorders (in the past 5 years) * subjects who have been lapsed into unconsciousness for an hour because of other reasons than general anesthesia * subjects who have a history of hospitalization due to head injury * subjects who are unable to read even with glasses * subjects who are unable to understand the conversation due to the hearing defect (even with the hearing aid)

Keywords: alzheimer's disease ad tdcs transcranial direct current stimulation
the usefulness of staining lymph nodes during operations for cancer thyroid in detecting the nodes that have cancer

Conditions: Thyroid Cancer; Lymph Node Metastasis

Summary: detection of lymph nodes starting to be involved by cancer spreading from the thyroid gland during operation is useful. it saves the patient from having a second operation to remove these nodes later on when they become obvious. the problem is that there are many lymph nodes around the gland. the theory is that only one node will get the first spill of the tumour cells. in this study the investigators are trying to use an inert colored material to inject into the tumour. this should run in the same path as the tumour cells and should therefore stain the one lymph node that will be affected first should the tumour spread. the stained lymph node is excised and examined instantaneously for tumour affection. if it is found to be affected by the tumour, then the operation is extended to include removal of all its fellow lymph nodes. if it is found to be free from the tumour, then this patient does not have tumour spread.

the study includes 45 consecutive patients diagnosed as differentiated thyroid cancer by clinical examination and/or fine needle aspiration cytology (fnac). exclusion criteria are: previous neck surgery, pregnancy and known hypersensitivity to the dye used. an informed consent was obtained from all the patients. peroperative workup includes history taking, clinical examination, relevant laboratory investigations including thyroid hormone assay, ultrasonography of the neck with special emphasis on the thyroid focal lesion and cervical lymph nodes. fnac was attempted in all patients. all patients were then subjected to operation: a systematized surgical approach was adopted for the purpose of the study: this started by collar incision, development of sub-platysmal skin flaps and separation of strap muscles in the midline. this was followed by exposure of the thyroid gland; identification of the thyroid tumour; injection of the dye into the tumour; waiting for the dye to reach the lymph nodes; identifying the stained node; labeling it as the sentinel node (sln); performing total thyroidectomy and bilateral central neck dissection. the resected specimen was fixed by formaldehyde, stained with hematoxylin and eosin and examined with light microscopy. if the sln was found to be free of malignant deposits, it was further examined by immunohistochemical staining. statistical analysis: descriptive statistics were used to analyze demographic data. sensitivity, specificity and predictive value of the sln were calculated. the histopathological report of the excised specimen was considered the criterion standard.

Eligibility criteria:
inclusion criteria: * patient diagnosed to have differentiated thyroid carcinoma and has no detectable cervical lymphadenopathy. exclusion criteria: * previous neck surgery, pregnancy and known hypersensitivity to the dye used.

Keywords: sentinel lymph node thyroid cancer neck dissection
safety/efficacy study of optimizing ibuprofen dosing to achieve higher pda closure rates

Conditions: Patent Ductus Arteriosus

Summary: the purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.

failure to close the pda in premature neonates in a timely fashion can lead to pulmonary over-circulation and systemic under-circulation. the pda often fails to close using currently approved ibuprofen dosing regimens, and surgical closure becomes necessary. ibuprofen clearance in premature neonates is significantly correlated with postnatal age, increasing rapidly over time. hirt et al. published and optimized dosing scheme for preterm neonates based on pharmacokinetic and pharmacodynamic data. we aim to use this dosing regimen in the clinical setting to determine if increased rates of pharmacologic pda closure can be achieved.

Eligibility criteria:
inclusion criteria: * all neonates (0-29 days old) less than or equal to 33 post-menstrual age at time of pda diagnosis requiring nasal cpap or mechanical ventilation * echo confirmed pda with a transductal diameter of 1.5 mm or greater and demonstrating a left-to-right shunt * signed informed consent exclusion criteria: * presence of: ductal-dependent congenital heart disease, pulmonary hypertension, * active bleeding (including grade 3 or 4 ivh) * platelet count \< 100,000 * coagulopathy * suspected nec * suspected perforation * creatinine \> 1.5 * hyperbilirubinemia requiring exchange transfusion * hypotension requiring pressor support * life-threatening congenital malformation

Keywords: pda ibuprofen preterm neonate
a phase 1 study to assess single and multiple ascending doses of pbi-100 topical cream

Conditions: Healthy Volunteers; Psoriasis

Summary: this is a phase 1, randomized, double-blind, vehicle-controlled, sad / mad study evaluating three dose levels of pbi-100 topical cream in healthy adult volunteers and/or subjects with psoriasis.

this is a phase 1, randomized, double-blind, vehicle-controlled, sad / mad study. three dose levels of pbi-100 topical cream will be evaluated in healthy adult volunteers and/or subjects with psoriasis. dose escalations will follow a satisfactory review by the safety review committee of all available safety, tolerability, and pk data from the current dose level.

Eligibility criteria:
key inclusion criteria: * is male or female, between 18 and 65 years of age * has a body mass index (bmi) between 18.0 and 32.0 kg/m2 * is in good general health, as determined by the investigator, without clinically significant medical history, with the exception of psoriasis for those subjects enrolled in the psoriasis groups key exclusion criteria: * has any visible skin disease (other than psoriasis for subjects in groups 4 and 7) at the application site which, in the opinion of the investigator, would interfere with the evaluation of the test site reaction
single subject neratinib in bladder cancer (nrr)

Conditions: Bladder Cancer

Summary: this study will be a single subject study to evaluate the efficacy of the her2 kinase inhibitor, neratinib, in a patient with metastatic bladder cancer harboring a her2-grb7 gene fusion.


Eligibility criteria:
inclusion criteria: \* none exclusion criteria: \* none we have received fda approval for a single subject investigational new drug (ind) application to treat a specific patient with the her2 kinase inhibitor neratinib. therefore there is no inclusion / exclusion criteria.

Keywords: bladder cancer neratinib 13-2526
pirfenidone use in asbestosis patients: efficacy and prognosis

Conditions: Asbestosis

Summary: this study aims at determining the the efficiency and prognosis of using pirfenidone drug among asbestosis patients.

asbestos exposure is associated with pleural and lung fibrosis and lung cancer. it has pathomechanisms and clinical similarities to interstitial pulmonary fibrosis disease. there is no definite cure for asbestosis. pirfenidone has antifibrotic and anti-inflammatory effects.the safety and effectiveness of pirfenidone for the treatment of non-interstitial pulmonary fibrosis progressive fibrotic interstitial lung diseases remain unclear including asbestosis. only few studies for pirfenidone use in asbestosis.

Eligibility criteria:
inclusion criteria: * male patients aged ≥ 18 years old * patients who fulfilled investigations according the study protocol. * patients who kept on follow up for the entire study. * all patients fulfilling the clinical and radiological criteria of asbestosis (existence of asbestos-specific pleural changes in high resolution computed topography hrct (pleural plaques), reticular changes in hrct and restrictive lung function pattern, history of asbestos exposure, absence of an alternative explanation for fibrotic lung disease ) * clinically stable patients. * patients who signed informed consent * patients with mild-to-moderate ipf \[forced vita capacity (fvc) ≥50% of predicted and diffusion capacity of carbon monoxide (dlco) ≥30% of predicted\]. * duration since diagnosis (at least one year before the study) exclusion criteria: * patients with peptic ulcer, * severe hepatic disease, hepatitis c infection or any of the following liver function test criteria above specified limits: aspartate or alanine aminotransferase (ast or alt) \>2.5 u above upper limit of normal level. * severe kidney disease, cardiac disease, and patients with other chronic pulmonary diseases, lung cancer * presence of coexisting respiratory infection * history of alcohol or drugs abuse * patients with neuromuscular disease, * chronic renal failure, * patient on oxygen therapy, * life expectancy less than 6 months, * history of malignancy.

Keywords: pirfenidone asbestosis
a re-licensing study to assess the efficacy of inflexal v formulated with who recommended 2009/2010 influenza virus strains for the northern hemisphere

Conditions: Influenza

Summary: this study is to assess whether the northern hemisphere 2009/2010 season influenza vaccine inflexal v fulfills the emea requirements for re-registration of influenza vaccines.


Eligibility criteria:
inclusion criteria: * healthy female and male adults * aged ≥18 to ≤60 years or \>60 years on day 1 * written informed consent exclusion criteria: * acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease * acute febrile illness (≥38.0 °c) * prior vaccination with an influenza vaccine in the past 330 days * known hypersensitivity to any vaccine component * previous history of a serious adverse reaction to influenza vaccine * history of egg protein allergy or severe atopy * known blood coagulation disorder * chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed) * known immunodeficiency (incl. leukemia, cancer, hiv seropositivity) * investigational medicinal product received in the past 3 months (90 days) * treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days) * pregnancy or lactation * participation in another clinical trial * employee at the investigational site, or relative or spouse of the investigator * suspected non-compliance

Keywords: influenza virus vaccination immunisation
cediranib in combination with lomustine chemotherapy in recurrent glioblastoma

Conditions: Recurrent Glioblastoma

Summary: the purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. two drugs are being tested in this study. lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. cediranib is a new drug that has not yet been approved for this disease. this study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.


Eligibility criteria:
inclusion criteria: * confirmation of recurrent glioblastoma * life expectancy ≥ 12 weeks * received only one prior systemic chemotherapy regimen and this regimen must contain temozolomide exclusion criteria: * patients on enzyme-inducing anti-epileptic drugs within 3 weeks prior to randomisation * poorly controlled hypertension * previous anti-angiogenesis (eg bevacizumab, sorafenib, sunitinib) therapy

Keywords: cancer tumour advanced solid tumour gbm glioblastoma