Kornimate/medical-research-clean huggingface dataset:
pharmacological modulation of peripheral nerve excitability

Conditions: Peripheral Neuropathy

Summary: the present project is a human experimental study. the aim is to assess the pharmacologically modulated excitability of peripheral sensory nerves with a human experimental model. the study measures the excitability of peripheral sensory nerves before and after application of different topical drugs (lidocaine (5%), phenytoin (10%),mepyramine (2%) and placebo).

design and method study design the study is a randomized, double-blinded, placebo-controlled study. to minimize the risk of bias and achieve balance in the allocation of participants and application of creams, block randomization is used. to ensure double blinding, 1-2 colleagues from center for neuroplasticity and pain (cnap), who is not otherwise involved in the project, will keep the randomization list in a secure room. study procedure and experimental test the ptt model will be used to measure the excitability of peripheral sensory afferents. ptt will be measured before and after topical drug application at four distinct areas - two at each side of the volar site of the forearms. in total four topical creams will be used in the study. one cream containing placebo, one with lidocaine (5%), one with phenytoin (10%) and one with mepyramine (2%). the study consists of one session lasting 3-4 hrs. the study will include 20 healthy volunteers.

Eligibility criteria:
inclusion criteria: * men and women age \> 18 years * understand and speak danish * no medication besides contraceptives exclusion criteria: * pregnancy or lactating women * drug addiction (use of cannabis, opioids, or other drugs) * use of pain killers, alcohol, or nicotine within the last 24 hours before study start * any other medical treatment (e.g., antidepressants, anticonvulsants) * history of peripheral or chronic pain conditions / neuropathy * skin diseases * scars and/or tattoos at the volar site of the forearm * previous traumatic experience of an electrical accident * application of moisturizing lotion of the volar site of the forearms (24 hours before study start) * participation in any other research projects/studies 7 days before study start * known allergy/intolerance to lidocaine/phenytoin/mepyramine * lack of ability to cooperate

Keywords: topical treatment small fiber excitability perception threshold tracking method
hepatoprotective for children and adolescent with acute lymphoblastic leukemia

Conditions: Leukaemia (Acute); Acute Lymphoblastic Leukemia

Summary: this current study will implement a proposed whole program of monitoring and prevention acute hepatic injury during the time of induction chemotherapy in children and adolescent with all.

children and adolescent with acute lymphoblastic leukemia (all) can exhibit a wide spectrum of hepatotoxicity ranging from asymptomatic to clinically significant during induction chemotherapy. unmonitored hepatic status can lead to a hepatic toxicity that might result in unwarranted interruption of the aimed delivery of dose dense chemotherapy to induce remission and consequent treatment. to evaluate the effect of chemotherapy in children and adolescent with all during induction phase, through recording liver function tests before, during and after induction chemotherapy.

Eligibility criteria:
inclusion criteria: children and adolescents aged from 2 to 18 years newly diagnosed with acute lymphoblastic leukemia during induction phase of chemotherapy treated at ain shams exclusion criteria: known chronic liver disease.

Keywords: acute lymphoblastic leukemia hepatoprotective program
cow's milk allergy in infants with obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea Syndrome

Summary: cow's milk allergy may be involved in the evolution of sleep apnea in infants. the study will assess the effects of specifies diet changes (i.e. non-milk based formula) on the infant. specifically , infants will be investigated by sleep studies in order to test this hypothesis.


Eligibility criteria:
inclusion criteria: 1. polysomnographically diagnosed osa 2. age is 2-24 months 3. clinical suspicion of milk allergy due to findings in the medical history or physical exam exclusion criteria: 1. congenital defects in the pulmonary and gastrointestinal systems 2. family history of genetic diseases or familial syndromes 3. infantile asthma.

Keywords: obstructive sleep apnea syndrome the study examines the response of infants diagnosed with obstructive sleep apnea syndrome to diet changes
hemodynamic responses to rlx030 infusion in subjects with acute heart failure

Conditions: Acute Heart Failure

Summary: this study will assess the hemodynamic effect of rlx030 infusion in subjects with acute heart failure. in addition safety and effects on renal function and biomarkers will be assessed.


Eligibility criteria:
inclusion criteria: * patients hospitalized or requiring admission to hospital for management of acute heart failure within the previous 48 hours. * pulmonary wedge pressure above or equal to18 mmhg determined by right heart catheterization exclusion criteria: * systolic blood pressure below 115 mmhg * significant valvular diseases or arrythmias * acute coronary syndrome in previous 45 days * treatment with mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) * impaired renal or hepatic function other protocol-defined inclusion/exclusion criteria may apply

Keywords: heart failure rlx030 hemodynamics cardiovascular diseases
telerehabilitation in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the main aim of the study is to evaluate the efficacy of the virtual reality rehabilitation system (vrrs, khymeia) compared to usual care treatment for patients with ms at home. the effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with a comparison group receiving usual care training. the investigators will assess the effect of vrrs system on the quality of life, motor, and cognitive abilities. (phase i) in the second phase of the present study we aim to evaluate the effects induced by the treatment of active (anodal) transcranial direct current stimulation (tdcs) applied to the left dorsolateral prefrontal cortex (ldlpfc) combined with vrrs compared to placebo tdcs stimulation combined with vrrs. the effects of the intervention patient-relevant outcomes will be assessed using a randomized controlled trial design with four groups. the investigators will assess the effect of vrrs system on patient-relevant outcomes motor, cognitive and participation. (phase ii)


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple sclerosis (rr and sp) based on mcdonald criteria * education ≥ 8 ages * italian mother language * right-handedness * use of corticosteroids for three months prior to the study, having and no acute exacerbations of symptoms within three months of the study. exclusion criteria: * existence of visual acuity and acoustic perception problems, to prevent performance of vrrs activities * relapses next to the time of enrolment (3 months) * edss \> 6.5.

Keywords: telerehabilitation virtual reality quality of life transcranial direct current stimulation
the value of short-term pain relief for the prediction of long-term outcome after cervical or lumbar nerve root infiltration

Conditions: Cervical Disc Herniation; Lumbar Disc Herniation

Summary: the purpose if this study is to assess the response to nerve root infiltration therapy in patients with cervical or lumbar disc herniations.

this prospective, observational study examines the response to routine infiltration therapy in patients suffering from disc herniations of the spine. using health-related quality of life questionnaires (sf-12 and neck pain and disability scale and oswestry disability index) and the visual analogue scale the patients will be categorized into ultra-early-, early-, mid-term-, late-responders and non-responders. a two year follow-up of up to 250 patients is planned. with the anonymized participation of this study no patient will experience a change in his treatment plan. valuable therapeutic management considerations might be drawn from the published results of this study for future patients.

Eligibility criteria:
inclusion criteria: * symptomatic (pain) one-level cervical (c3-c8) or lumbar (l1-s1) radiculopathy with radiological evidence of discal nerve root compression * minimum vas of 20/100 * age between 18 - 70 years exclusion criteria: * multilevel disc herniations with multiple symptomatic nerve root compressions * higher motor deficits (paresis m 0-3 of a peripheral muscle) * age \ 70 years * pregnancy * allergic reaction against steroids or local anaesthetic * bleeding disorder (tc \ 1.5, abnormal ptt) * known bleeding diathesis * continued anticoagulants (warfarin = marcoumar must be bridged with low- or high-molecular heparin; commonly, intake of aspirin or clopidogrel is no contraindication for infiltration therapy but is routinely paused when possible) * pseudoradicular pain (e.g. in facet arthrosis, iliosacral arthrosis...) - as evaluated to the best of the knowledge of the admitting physician and radiologist performing the infiltration * osseous spinal or foraminal stenosis * myelopathy * severe scoliosis * active neoplasm * history of spinal infection / spondylodiscitis * history of spinal surgery or previous infiltration therapy on the currently painful segment * rheumatic disease

Keywords: infiltrative therapy cervical disc herniation lumbar disc herniation
pivka-ii for predicting portal vein thrombosis in hepatocellular carcinoma

Conditions: Hepato Cellular Carcinoma (HCC); Portal Vein Tumour Thrombosis

Summary: the goal of this cross-sectional observational study is to evaluate the relation between prothrombin induced by vitamin k absence ii (pivka-ii) and the presence of portal vein tumor thrombosis (pvtt) in hepatocellular carcinoma (hcc) patients. researchers will compare pivka-ii serum levels in hcc patients with pvtt and without pvtt. participants will undergo history-taking, clinical examination, laboratory investigations, pivka-ii serum level, child-pugh classification, model for end-stage liver disease (meld) score, bclc staging, abdominal ultrasonography, and triphasic ct abdomen with contrast or mri to evaluate tumor site, size, number, and presence of pvtt (a filling defect in the portal vein or its branch to distinguish pvtt or thrombus).


Eligibility criteria:
inclusion criteria: * male or female patients older than 18 years. * patients with confirmed hcc with or without pvtt (diagnosed by two imaging modalities or one imaging modality with elevated serum alpha fetoprotein or liver biopsy). exclusion criteria: * prior locoregional therapy or liver transplantation. * patients on vitamin k, vitamin k antagonists or antibiotics. * patients with cholestasis. * patients with renal insufficiency. * patients with other malignancies. * unwilling to participate in our study.

Keywords: pivka-ii portal vein tumor thrombosis hepatocellular carcinoma
periaqueductal gray-vagus nerve interface malfunction explain the natural history with its numerous co-morbidities?

Conditions: Postural Tachycardia Syndrome

Summary: this study is being conducted to see how people with postural tachycardia syndrome (pots) make sense of the things they see. the information may help doctors to learn more about how the different parts of people's brains communicate.


Eligibility criteria:
inclusion criteria: * females 12-21 years old * able to communicate and provide consent/assent * english speaking * diagnosed with pots (pots will be defined standardly as a symptomatic ≥ 40 bpm rise in heart rate without a drop in blood pressure and with symptoms of orthostatic intolerance clinically) * age-matched healthy control subjects: no pots or other neurological disorders exclusion criteria: * inflammatory arthritis, connective tissue or auto-immune disorder * any chronic neurological disorder besides pots * evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising ast or alt, or end-stage with coagulopathy), poorly controlled significant cardiovascular (chf), respiratory, endocrine (diabetes - a1c \> 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.) * neuropathy, central nervous system disorder (e.g., cerebral palsy, developmental delay, seizure disorder, ms, stroke, etc.) * treatment with a drug or medical device within the previous 30 days that has not received regulatory approval * use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented) * current substance or alcohol abuse * any major surgical intervention with general anesthesia in the last 60 days and minor procedure, such as tooth extraction, endoscopy, etc., with local or conscious sedation within 7 days * any on-going or pending medical, health or disability related litigation, or current pursuit of disability * any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented) * chronic use of narcotics for pain * claustrophobia or any metal hardware that may interfere with mri * investigators and study staff
immunostimulatory cpg sd-101 + rt in recurrent/progressive lymphoma after allogeneic hematopoietic cell transplantation (hct)

Conditions: Lymphoma, Non-Hodgkin; Hodgkin Disease

Summary: for patients with lymphoma that recurs after chemotherapy, bone marrow transplantation using cells from a healthy donor represents potentially curative treatment. in these individuals, cure is possible because transplantation of healthy donor immune cells can fight the lymphoma in the patient. the goal of this work is to test a strategy that activates the healthy donor immune cells so that they more effectively fight lymphoma and can result in an increased cure rate for these patients. our group has previously studied cpg, an immune activating medication, in patients with lymphoma and demonstrated modest anti-tumor responses. we now have a more potent form of cpg which we intend to test to see if it will better activate the donor immune cells and result in shrinkage of tumor throughout the entire body, not just at the injected site.

patients will receive low dose radiation to all bulky or symptomatic lymph nodes on days -2 and -1. sd-101 will be administered intratumorally to the single largest palpable node within 24 hours after completion of radiation, on day 0. two additional intratumoral sd-101 injections will be performed on days 7 (+/- 2 days) and 14 (+/- 2 days). this is a dose ranging study using a 3+3 design with a definition of maximum tolerated dose (mtd) which our group has found acceptable in the past. the first cohort of patients will receive a sd-101 dose of 0.3 mg per injection. the dose will be escalated to 1 mg and 3 mg based on dose limiting toxicity (dlt).

Eligibility criteria:
inclusion criteria: * biopsy-confirmed relapsed, refractory, or progressive nhl or hl (refer to section 3.2.1 for excluded subtypes) * at least 3 sites of disease 1. one for diagnosis (lymph node or bone marrow biopsy) 2. one palpable for treatment 3. one measurable radiographically * \> 60 days after ric allogeneic transplant for lymphoma * 18 years of age or older * mixed (5-95%) or complete (\>95%) chimerism * eastern oncology cooperative group (ecog) performance status ≤ 2 * anc \>1000/mm3, platelets \>50,000/mm3 * total bilirubin ≤ 2.5 mg/dl, ast and alt \< 3 times upper limit of normal * serum creatinine ≤ 3 mg/dl * no chemotherapy, rt, dli or biologic therapy for lymphoma at least 4 weeks prior to scheduled treatment * minimal immunosuppression (defined as monotherapy with ≤ 10 mg prednisone daily, ≤ 200 mg cyclosporine daily, or ≤ 2 mg tacrolimus daily) at least 2 weeks prior to scheduled treatment exclusion criteria: * hiv associated lymphoma * acute gvhd at time of enrollment (history of treated and resolved gvhd is permitted) * active infection within 14 days prior to scheduled treatment * active cytomegalovirus (cmv) disease at the time of enrollment * pre-existing autoimmune or antibody mediated disease (including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, sjogren's syndrome, and autoimmune thrombocytopenia) * pregnant
prognostic value of bnp in mcs - a 25 year follow up study

Conditions: Heart Failure; Left Ventricular Assist Device; Prognosis; Durable Mechanical Support Device

Summary: a biobank has been created to investigate the prognostic value of biomarkers (mainly bnp) in patients implanted with durable mechanical assist devices comparing patients with advanced hf supported by mcs with those who are transplanted and those who remain on optimal medical therapy. patients will be followed up for 25 years after inclusion.

all patients referred for advanced hf treatment at the dept of cardiology at rigshospitalet.

Eligibility criteria:
inclusion criteria: * all patients referred for evaluation for advanced hf treatment at the rigshospital in denmark * age\>18 years exclusion criteria: * no consent
an app to reduce cannabis use among emerging adults

Conditions: Cannabis Use

Summary: this study is being completed to pilot prevention methods to promote wellness and reduce risky behaviors, including the use of substances such as cannabis. this study will help researchers learn about ways of delivering this information that is both appealing and helpful to young adults who use mobile apps.


Eligibility criteria:
inclusion criteria: * reside in the us * speak and read english * have a smartphone on which the app can be downloaded * screen positive for cannabis use 3 or more times each week over the past month * report motivation to change cannabis as 1 or higher (using scale of 0-10) * meet study verification criteria (i.e., use of captcha, ip address checks) exclusion criteria: * use of medical cannabis * failure to meet study verification criteria

Keywords: cannabis use marijuana substance-related disorders mental disorders
duotrav aps versus xalacom® in ocular surface health

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: to demonstrate superiority of duotrav aps over xalacom® in ocular surface health in patients with open angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years of age. 2. must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least one eye. 3. must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study. 4. must have had iop controlled with mono-therapy using xalacom for at least 1 continuous month prior to visit 1. 5. women of childbearing potential must meet all specific conditions at visit 1: exclusion criteria: 1. any abnormality preventing reliable applanation tonometry in the study eye(s). 2. presence of any ocular pathology in either eye seen during the slit lamp or fundus exams that may preclude the safe administration of test article or safe participation in this study. 3. dry eye or kcs which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, restasis®, or topical ocular corticosteroids. 4. patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, within 1 year prior to visit1 5. any other ocular laser surgery in either eye within 3 months 6. patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to visit 1. 7. history of other progressive retinal or optic nerve disease. 8. severe central visual field loss in either eye based upon the clinical judgment of the investigator. 9. any history of, or current evidence of, infectious or inflammatory ocular conditions 10. ocular trauma within 6 months prior to visit 1 in either eye, as determined by patient history and/or examination. 11. history or evidence of corneal transplant or transplant variant procedures 12. patients with suspected or diagnosed sjogren's syndrome. 13. history of or current bronchial asthma, or severe chronic obstructive pulmonary disease 14. history of or current severe, unstable or uncontrolled cardiovascular, hepatic, or renal disease. 15. history of spontaneous or current hypoglycemia or uncontrolled diabetes. 16. history of or current severe allergic rhinitis and bronchial hyper reactivity. 17. intolerance/hypersensitivity to any component of the medication 18. use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to visit 1, or an anticipated change in dosing regimen of medications during the course of the study. 19. use of ocular medications other than xalacom® within 7 days 20. use of corticosteroids within 30 days of visit 1, or any anticipated use of corticosteroids during the course of the study. 21. use of contact lenses within 30 days of visit 1. concomitant use of contact lenses is also excluded for the duration of the study.

Keywords: oag oh
cervical cytology dna methylation for cervical cancer screening

Conditions: Cervical Cancer; DNA Methylation; Cytology; Human Papillomavirus Infection; Cervical Intraepithelial Neoplasia; Cancer Screening

Summary: cervical cancer represents one of the foremost causes of cancer-related morbidity and mortality among women worldwide. given the current limitations, such as the low specificity of human papillomavirus (hpv) testing and the relatively low sensitivity of cytological examinations, there is a pressing need for a novel, non-invasive, safe, and precise screening method. this study aims to undertake a multicentre, real-world investigation, incorporating at least 10 sub-centres and enrolling 30,000 participants. histopathological examination results will serve as the 'gold standard' for evaluating the screening efficacy of human pax1 and jam3 gene methylation assays (pax1m/jam3m), hpv testing, and cytological examinations. furthermore, the study seeks to elucidate the relationship between dna methylation levels and persistent hpv infection, while also assessing the applicability of pax1m/jam3m across diverse clinical settings. by focusing on alterations in dna methylation levels within cervical exfoliated cells as the primary research trajectory, this study aspires to furnish novel insights and theoretical foundations for the prevention and management of cervical cancer, targeting pax1m/jam3m. the ultimate objective is to facilitate the clinical implementation of an enhanced cervical cancer screening protocol, thereby addressing the deficiencies of current screening methodologies, achieving greater precision in cervical cancer screening, and effectively reducing the incidence of cervical cancer while mitigating the risks of overdiagnosis and overtreatment.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * with uterine cervix intact * given consents to participate the study * with detailed follow-up outcomes exclusion criteria: * not meeting all of the inclusion criteria