Kornimate/medical-research-clean huggingface dataset:
chronic venous ulcer treatment analyzing bio-electrical stimulation therapy

Conditions: Chronic Venous Leg Ulcers

Summary: indication: subjects with chronic venous leg ulcers primary objective: • to evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers secondary objective(s): * to evaluate the percentage of wound healing every two weeks * to evaluate the complete ulcer healing every two weeks * to evaluate the time to complete ulcer healing * to evaluate the recurrence rate at the end of the follow-up period * to evaluate pain * to evaluate the quality of life study design and treatment scheme: this is a kingfisher healthcare nv sponsored, national, multicenter, randomized, prospective study in which data will be collected of subjects with chronic venous leg ulcers receiving standardized conventional therapy (sct). subjects will be randomized into two groups receiving sct + placebo or sct + bio-electrical stimulation therapy (best) to evaluate the effect of best on the wound healing process. patients answering the eligibility criteria will receive standardized conventional therapy during 4 weeks before actual study start and will then again be evaluated on eligibility according to wound healing rate. only patients with a wound surface that has not significantly changed (both increased or decreased) will be randomized in the treatment period. during the treatment period patients will receive sct with placebo or sct in combination with bio-electrical stimulation therapy on a daily basis for two hours, during 8 weeks. patients will be in follow-up period for a maximum of 8 weeks after treatment period.

see above

Eligibility criteria:
inclusion criteria: * adult subjects ≥ 18 years old, male or female * before any subject data is collected, the appropriate written informed consent must be obtained (see appendix h). * confirmation of venous insufficiency during the last 5 years by duplex examination * chronic venous leg ulcers (\>12 weeks) not healing with conventional therapy * study ulcer size between 8 to 20 cm² and without clinical signs of infection * no presence of other ulcers in a radius of 5 cm around the study ulcer * no surgery for venous insufficiency within the last 6 months * no arterial insufficiency (abi between 0,7 and 1,3) * bmi \< 40 * no uncontrolled diabetes or any uncontrolled systemic condition that might impair wound healing * no decubitus wounds * ambulant subject * written informed consent exclusion criteria: * subjects with implanted electrical devices (e.g. cardiac pacemakers) * subjects having a concurrent malignancy or being less than 3 years after the end of their cancer therapy * subjects with active osteomyelitis * pregnant or breast-feeding women

Keywords: bio-electrical stimulation therapy chronic venous ulcers microcurrent chronic wounds complete healing
effect of chemoradiotherapy on nutritional status in advanced npc patients

Conditions: Nasopharyngeal Carcinoma; Malnutrition

Summary: this is an prospective，open-label, none-interventional, observational， multicenter phase ii clinical trial. the purpose of this study is to observe the effect of neoadjuvant chemotherapy followed by concurrent chemoradiation therapy(ccrt) on nutritional status in locoregionally advanced nasopharyngeal carcinoma(npc) patients, analyse the changes of patients' nutrition status during the treatment and the connection between nutrition changes and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and ccrt and provide data and basis for further study。


Eligibility criteria:
inclusion criteria: * newly histologic diagnosis of nasopharyngeal carcinoma(who ii) * all genders，range from 18～65 years old * karnofsky performance status(kps) ≥ 80 * clinical stage iii\~ivb(uicc 7th) * without significant digestive system disease，nutritional and metabolic diseases or endocrine disease * without significant cardiac，respiratory，kidney or liver disease * not received radiotherapy, chemotherapy and other anti-tumor treatment(including immunotherapy) * white blood cell(wbc) count ≥ 4×109/l, neutrophile granulocyte(ne) count ≥ 1.5×109/l, hemoglobin(hgb) ≥ 10g/l, platelet(plt) count ≥ 100×109/l * alanine aminotransferase (alt) or aspartate aminotransferase(ast) \< 1.5×upper limit of normal(uln), bilirubin \< 1.5×uln, alanine aminotransferase (ccr) ≥ 30ml/min * inform consent form exclusion criteria: * distance metastases * second malignancy within 5 years * drug or alcohol addition * do not have full capacity for civil acts * active systemic infections * chronic consumptions * mental disorder * pregnancy or lactation * concurrent immunotherapy or hormone therapy for other diseases * severe complication, eg, uncontrolled hypertension

Keywords: nutritional status locoregionally advanced nasopharyngeal carcinoma
ginkgolide with intravenous alteplase thrombolysis in acute ischemic stroke neurological improving trial

Conditions: Intravenous Alteplase Thrombolysis; Neurological Improving

Summary: previous clinical studies have confirmed that revascularization or recanalization rate after intravenous thrombolysis is closely related to the formation of thrombus, which also results in poor neurological function after thrombolysis. platelet activating factor (paf) strong platelet aggregation may be involved in thrombosis. formation process. the main components of ginkgolide injection (ginkgo) are ginkgolide, ginkgolides a, ginkgolides b and ginkgolides c. ginkgo biloba lactone can antagonize paf and has strong anti-platelet aggregation. . therefore, it can be speculated that ginkgolides injection combined with alteplase intravenous thrombolysis may improve the recanalization rate after thrombolysis and reduce the reocclusion rate. in addition, clinical studies have also found that ginkgolide injection has a good auxiliary effect on hypertensive intracerebral hemorrhage, which can regulate inflammatory factors such as il-6, tnf-α and high-sensitivity c-reactive protein (crp) in patients. recovery of neurological function in patients. it is well known that tnf-α, il-β, il-1, il-6, ifn-γ, etc. are all inflammatory factors associated with reperfusion injury. therefore, we speculate that ginkgolides injection may also regulate inflammatory factors associated with reperfusion injury, such as il-6, tnf-α, thereby reducing reperfusion injury, thereby improving patient prognosis. the aim of this study was to determine the clinical efficacy of ginkgolides injection combined with alteplase in the treatment of acute ischemic stroke, and to improve the prognosis of patients with thrombolysis.


Eligibility criteria:
inclusion criteria: 1. age over 18 years old, clinically diagnosed as acute ischemic stroke; 2. in accordance with the indications for intravenous thrombolysis; 3. the patient or family member signs an informed consent form. exclusion criteria: 1. patients with transient ischemic attack; 2. imaging examination of patients with cerebral hemorrhage 3. patients with cerebral arteritis 4. alt, ast ≥ 3 times the upper limit of normal value, cr ≥ 1.5 times the upper limit of normal value 5. there is a tendency to bleed, and severe bleeding has occurred within 3 months 6. patients with ginkgo drugs, alcohol, glycerol allergies or allergies 7. patients with pregnancy plans, pregnancy and breastfeeding 8. patients who participated in other drug clinical studies in the past month 9. patients considered by the investigator to be unfit to participate in the clinical study (eg, mental, abnormal, etc.)
allogeneic stem cell transplantation (sct) after dose-reduced conditioning for myelofibrosis patients

Conditions: Myelofibrosis

Summary: the purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation is a feasible and effective treatment for patients with primary myelofibrosis.

the purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from related or unrelated donors is a feasible and effective treatment for patients with primary myelofibrosis.

Eligibility criteria:
inclusion criteria: * disease: histologically proven myelofibrosis with myeloid metaplasia/mmm defined as per the italian consensus conference on mmm diagnosis with either primary mmm or secondary to polycythaemia vera or essential thrombocythaemia with * "intermediate risk" or "high risk" score according to the lille scoring system * or "low risk" score according to the lille scoring system with constitutional symptoms (fever, night sweat, weight loss \> 5% of body weight) * or "high risk" score according to the cervantes score * age: * patients between 50 and 70 years of age and no limited life expectancy for other reasons than mmm * patients under 50 years of age who are not eligible for a standard myeloablative conditioning, (e.g., because of prior autologous stem cell, history of severe infections like fungal infections, history of cardiac toxicity or other reasons according to the treating physician) * hla compatible or identical donor, related or unrelated (one mismatch allowed) * written informed consent of the patient exclusion criteria: * positive search for bcr-abl on blood. * serious irreversible renal, hepatic, pulmonary or cardiac disease * central nervous involvement * positive serology for hiv * pregnant or lactating women * patients with a life-expectancy of less than six months because of another debilitating disease * serious psychiatric or psychological disorders

Keywords: hematopoietic stem cell transplantation
optimizing cimzia in crohn's patients

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine if increasing the dose and/or dosing frequency of certolizumab pegol (cimzia) is effective in regaining and optimizing response in patients with moderate to severe crohn's disease.

this open label study for patients with moderate to severe crohn's disease will evaluate treatment options to improve capture of initial response and to regain loss of response to certolizumab pegol (cimzia). it is a 26 week open label clinical trial that may be extended to 52 weeks in patients who respond to treatment during the initial 26 week study. the following dosing options will be tested: 1) re-induction (one supplemental dose of 400mg) 2) dose splitting (200mgq2w) and 3) dose escalation (400mg q2w. the highest dose in the study, 400mg q2w, has been used in a large phase iii trial (welcome) without any new safety signals. efficacy and safety measures will be monitored.

Eligibility criteria:
inclusion criteria: * ileal and/or colonic crohn's disease * moderate to severe crohn's disease exclusion criteria: * short bowel syndrome * ostomy * anti-tnf therapy within 4 weeks * prior certolizumab therapy
machine learning to predict acute care during cancer therapy

Conditions: Chemotherapeutic Toxicity

Summary: the objective of this study is to apply a validated machine-learning based model (shield-rt, nct04277650) to a cohort of patients undergoing systemic therapy as outpatient cancer treatment to generate an automatic system for the prediction of unplanned hospital admission rates and emergency department encounters.

a previously described machine learning (ml)-based model accurately predicted ed visits or hospitalizations for cancer patients undergoing radiation therapy or chemoradiation. an irb approved prospective randomized trial, shield-rt (nct04277650) found that preemptive intervention for patients undergoing radiation and chemoradiation based on the ml model's risk stratification decreased the relative risk of acute care visits by 50%, showing that ml-guided escalation of care improved personalized supportive care and treatment compliance while decreasing healthcare costs. the objective of this study is to apply this validated ml based model to a cohort of patients undergoing systemic therapy as outpatient cancer treatment to generate an automatic system for the prediction of unplanned hospital admission rates and emergency department encounters. once validated, this study will add to the previously published body of evidence supporting a randomized trial evaluating the ml algorithm's ability to assign intervention for patients receiving systemic therapy at highest risk for acute care encounters.

Eligibility criteria:
inclusion criteria: * had treatment encounter in the duke medical oncology department from january 7th, 2019 to june 30th, 2019 * duhs medical record available exclusion criteria: -

Keywords: machine learning algorithm outpatient
education against tobacco randomized trial in bosnia and herzegovina

Conditions: Tobacco Prevention; Tobacco; Schools

Summary: a two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention education against tobacco on the smoking behavior of adolescents in 7-11th grade of secondary schools in bosnia and herzegovina. the primary endpoint is the change in smoking prevalence between the two groups.


Eligibility criteria:
inclusion criteria: visiting grades 7-9 of regular secondary schools in bosnia and herzegovina. exclusion criteria: not fulfilling inclusion criteria.
cardioprotective effects of green tea versus maté intake

Conditions: Dyslipidemia; Inflammation; Obesity

Summary: the investigators aim to study the effects of green tea and maté consumption on lipid and inflammatory profiles in dyslipidemic and overweight subjects.

recommendations of lifestyle and dietary content changes are often made for primary prevention and improvement of many health conditions, including cardiovascular disease. for centuries, green tea (camellia sinensis) has been linked to good health. nowadays, it is considered a functional food because of its physiological benefits, mainly in terms of cardiovascular prevention. green tea is considered one of the best sources of phenolic compounds, which possess antioxidant properties that may contribute to a reduction in the risk of cardiovascular disease. lesser-known worldwide, but widely consumed in southern latin america countries, yerba mate tea (ilex paraguariensis) is also a good source of phenolic compounds. the antioxidant capacity of green tea has been extensively studied; however, few studies have reported that the antioxidant properties of maté tea is even greater than green tea. for this reason, the present study aims to compare the possible effects of the oral ingestion of maté and green tea on the lipid and inflammatory profiles in a southern brazilian population.

Eligibility criteria:
inclusion criteria: * age 35-60 years * non-treated dyslipidemia (tc \> 200mg/dl and/or tg \> 150 mg/dl and/or hdl-c \< 40 mg/dl for men and 50mg /dl for women) * bmi 25-35 kg/m² exclusion criteria: * use or indication for use of lipid-lowering agents and/or vitamin supplement * non-steroids anti inflammatory use * hormone replacement therapy * contraceptive use * pregnancy * nursing * unexplained weight loss (\>2 kg) 2 months before the study * altered hepatic function * those who do not sign the informed consent

Keywords: camellia sinensis ilex paraguariensis green tea yerba mate tea maté dyslipidemia inflammation obesity
outcome study of patients treated with translational cervical plate used to treat degenerative disc disease

Conditions: Degenerative Disc Disease

Summary: the purpose of this study is to measure the benefits of anterior (from the front) cervical (neck) surgery for degenerative disc disease. the research part of this study is the answering of questionnaires by the patient concerning their quality of life, prior to, and after surgery.

this is a prospective, multi-center, four-arm study designed to evaluate the clinical and radiographic outcomes in patients diagnosed with cervical degenerative disc disease (ddd) and treated using the vectra-t cervical plate and the advanced acf or corticocancellous allograft spacer made by synthes spine company (paoli, pa). this is not an investigational study (ide) and no investigational or experimental devices or procedures are included in this study.

Eligibility criteria:
inclusion criteria: * one to four levels (consecutive) cervical degenerative disc disease between c2 and c7, defined as at least one of the following: * disc herniation * axial neck pain (with or without radiculopathy or myelopathy) caused by spondylosis * functional deficit * neurological deficit which significantly limits patient's normal living * one to four cervical levels to be plated * patient is skeletally mature and at least 18 years of age * patient signs consent form * patient is available for long term (24 month) follow-up * etiology must be confirmed by mri or ct exclusion criteria: * spondylolisthesis greater than grade 1 at either level(s) to be instrumented * indications for complete corpectomy of any involved levels * posterior instrumentation is necessary at same levels * more than one previous failed anterior fusion attempt at the involved level(s) * has had more than one previous open, posterior, spine surgical procedures at the involved level(s) or pre-op instability on flexion/extension radiographs. * pregnant or interested in becoming pregnant during the study follow-up period * has a known sensitivity to device materials * mentally incompetent or prisoner * currently a participant in a study related to the treatment of cervical spinal disorders * pre-op instability\>3mm on flexion/extension x-rays

Keywords: prospective degenerative disc disease cervical translational plate
analysis of parameters indicating the intensity of suicidal behavior in psychiatric patients

Conditions: Suicidal Behaviour; Cognitive Functions Confusion

Summary: the aim of this study was to analyse the level of cognitive functioning of patients with history of suicidal behaviour suffering from depression and schizophrenia, and to evaluate their oxidative stress parameters and selected biochemical parameters on the basis of bloodwork.

the study was conducted among 120 patients hospitalized in the department of psychiatry of the umb (medical university of białystok). every participant gave their own voluntary and informed written consent. blood parameters tests were performed in the diagnostic laboratory of the university's clinical hospital and in the department of hygiene, epidemiology and ergonomics of the medical university of białystok. in the first stage of the study, an m.i.n.i. 7.0.2 interview was conducted with each patient to verify the intensification of suicidal behaviour. based on the scores, the patients were classified into one of eight groups: no suicidal behaviour group (g0k, g0m); group experiencing suicidal thoughts without a tendency of implementation (g1k, g1m); group experiencing suicidal thoughts with a tendency of implementation (g2k, g2m); group after a suicide attempt (g3k, g3m).the second stage of the study consisted of biochemical blood tests, where concentrations of vitamin d3, b12, folic acid, sodium, potassium, calcium, magnesium, chlorine, total cholesterol, ldl and hdl fractions, tg and metabolites of the oxidative stress pathway were determined. the following concentrations were determined: dityrosine (auf/mg protein), tos (nmol h2o2 equiv/mg protein), tac (umol/mg protein), osi (tos/tac ratio), frap (μmol/mg protein), gpx (mu/mg protein), sod (mu/mg protein) cat (nmol h2o2/min/mg protein), aopp (nmol/mg protein), no (nmol/mg protein), gsh (μg/mg protein). the third stage of the study consisted of the participants completing a cogstate computerized test to verify their cognitive functioning. the following cognitive functions were assessed: psychomotor drive (det), metastability of attention (idn), verbal memory, retrieval of learned material (islr) and verbal learning and memory (isl), visual learning and memory (ocl), processing speed (gmct), visual memory including deferred retrieval (gmr), executive functions (sets and gml), working memory (onb, twob).

Eligibility criteria:
inclusion criteria: * patients of clinical psychiatry * patients diagnosed with schizophrenia and depression * age: 20-50 years * gender: women and men exclusion criteria: * exclusion criteria were any present major medical illness (somatic or neurological disease) * use of psychoactive substances * decreased level of cognitive functioning * people who do not use a computer

Keywords: depression schizophrenia biochemical blood tests oxidative stress pathway
use of clarithromycin in mustard-induced bronchiolitis

Conditions: Bronchiolitis Obliterans; Acute Obliterating Bronchiolitis

Summary: we looked for the effectiveness of low-dose long-term prescription of clarithromycin in mustard-induced chronic pulmonary lesions, especially bronchiolitis obliterans


Eligibility criteria:
inclusion criteria: * his/her own will to participate * documented chemical exposure * clinical, spirometric and radiological findings were compatible with bo on high resolution computed tomography (hrct) exclusion criteria: * any drug reactions during the trial * history of sensitivity to macrolides * diarrhea, gray stool, jaundice, eosinophilia, acute cholestatic hepatitis, pruritis, dark urine, abdominal pain, osteomatosis, depression, taste change, behavioural changes, early fatigue, odynophagia, glossitis , dizziness * co-adminstration of: terfenadine, theophylline, carbamazepine, ergotamine, dihydroergotamine, warfarin, cisapride, digoxin, triazolam, phenytoin, steroids, any immunosuppressive, any systemic antibiotics * using drugs that he/she cannot discontinue * using drugs with potential interaction * subject will to exit from the trial * history of lobe resection of lung * history of exacerbation in the last month prior to the beginning of trial * continuous need to oxygen * use of corticosteroids in last week prior to the trial beginning * radiographic evidence of pneumonia, active tuberculosis, lung carcinoma, or an infection that necessitated the use of an antibiotic * exacerbating of subjects * creatinine srum level more than normal * increasing alt, ast levels * total bilirubin more twice than normal * subjects who did not use their drugs properly