Kornimate/medical-research-clean huggingface dataset:
a clinical evaluation of a honey impregnated dressing at removing necrotic tissue from chronic wounds

Conditions: Wound Heal; Necrotic Tissue Removal

Summary: the purpose of this study is to evaluate the effectiveness of a honey-impregnated wound dressing at removing necrotic tissue in subjects with chronic foot or ankle wounds.


Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age * subject has a qualified chronic foot or ankle wound, sized 1cm2 to 25 cm2 for ≥ 4 weeks in duration * must have necrotic tissue at least 25% of wound area * the wound type matches one of the indicated wounds listed on the product labeling: * leg ulcers * pressure ulcers * diabetic foot ulcers * first and second degree burns * surgical wounds * trauma wounds * subject has adequate circulation as demonstrated by biphasic or triphasic doppler waveform, consistent with adequate blood flow, within 3 months prior to study enrollment. if monophasic on exam, the non-invasive tests must display ankle brachial index over 0.8 and no worse than mild disease on segmental pressures. * subject is likely to be compliant with instructions for case, such as following institutional standard of care directions, offloading, and keeping the wound area protected from environmental contaminants * type i/ii diabetic subjects that meet the following criteria: * random blood glucose is less than 450 mg/dl within 30 days of the screening visit exclusion criteria: * subject has a known sensitivity or allergy to honey based products, bee venom, or other ingredients in product * the subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation * wound duration ≥ 52 weeks * the subject has a prognosis that indicated unlikely survival past the study period * the subject is currently receiving dialysis * gangrene is present in the target wound * patient's wound is infected * the subject's diagnosis indicates third degree burns * the subject has received any treatment prior to study enrollment that may, in the opinion of an investigator, affect the outcome of the study * in the opinion of an investigator, the subject is otherwise not suitable for study participation, such as the subject is likely to be non-compliant with study requirements
efficacy and safety of angelica gigas n. extract on improvement of hyperglycemia

Conditions: Hyperglycemia

Summary: this study was conducted to investigate the effects of daily supplementation of angelica gigas n. extract on improvement of hyperglycemia .

this study was a 8 weeks, randomized, double-blind, placebo-controlled 2×2 cross-over design human trial. twenty subjects were randomly divided into angelica gigas n. extract or a placebo group. fasting and postprandial glucose profiles during oral glucose tolerance test (ogtt) were assessed before and after the intervention.

Eligibility criteria:
inclusion criteria: * age 20-80 years with fasting glucose 100-125 mg/dl or 2 hour postprandial glucose 140-199 mg/dl exclusion criteria: * weight less than 48 kg or weight decreased by more than 10% within past 3 months * hypoglycemic agent, obesity medicine, lipid lowering agent within past 6 months or blood sugar, obesity and lipid improvement functional foods within past 2 weeks * treated with corticosteroid within past 4 weeks * severe cardiovascular disease(mvocardial infarction, stroke, etc) * renal disease(heredity hyperlipidemia, acute/chronic renal failure, nephrotic syndrome, etc) * rheumatoid arthritis, autoimmune disease * cancer, respiratory organ disease(asthma, chronic obstructive pulmonary disease) * allergic or hypersensitive to any of the ingredients in the test products * history of disease that could interfere with the test products or impede their absorption * under antipsychotic drugs therapy within past 2 months * history of alcohol or substance abuse * participation in any other clinical trials within past 2 months * laboratory test by show the following results * aspartate aminotransferase, alanine aminotransferase \> reference range upper limit treble * serum creatinine \> 2.0 mg/dl * pregnancy or breast feeding * not contraception(except: surgery for female infertility)

Keywords: angelica gigas n. extract glucose clinical trial
the effect of pregabalin given preoperatively on the tourniquet induced ischemia-reperfusion

Conditions: Ischemia Reperfusion Injury

Summary: the application of tourniquet is indispensable for a bloodless surgical area in total knee arthroplasty surgery. the release of tourniquet produces reactive oxygen species which can cause injury and then ischemia-reperfusion injury emerge. our aim in this study is to investigate effects of pregabalin, gaba analog drug, on the tourniquet induced ischemia-reperfusion injury.

investigators will randomize patients into two groups. 1) pregabalin group 2) control group. investigators will give orally pregabalin 150 mg to the pregabalin group patients two times (first dose 1 day before surgery., second dose 1 hour before surgery). on the other hand placebo drug will give to the control group at the same times. investigators will perform combined spinal epidural anesthesia for surgery and inject 3 cc 0.5% hyperbaric bupivacaine to subarachnoid space. investigators will take blood samples for measurement of ischemia-reperfusion determinants, immediately before surgery, shortly before tourniquet deflation, and 20 minutes after tourniquet deflation. then these samples will be analysed by elisa method.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists (asa) physical status i-ii 2. undergoing a total knee arthroplasty surgery 3. accept neuroaxial anesthesia for surgery exclusion criteria: 1. any antiepileptic drug use 2. allergic reaction to pregabalin 3. severe hepatic, renal or gastrointestinal disorders 4. psychiatric disorders 5. pregnant women or breastfeeding 6. nsaid or opioid drug use for a long time 7. diabetic or other neuropathic pain

Keywords: pregabalin ischemia reperfusion injury muscle
overnight switch from rasagiline to safinamide

Conditions: Parkinson Disease

Summary: rasagiline label report the indication to wait at least 14 days between discontinuation of rasagiline and initiation of another mao inhibitor. this results in a major inconvenience for parkinsonian patients (pd) due to their clinical worsening. safinamide is a reversible mao-b inhibitor, characterized by a good safety profile. in clinical practice safinamide is often introduced instead of rasagiline following an overnight switch. the aim of this study is to explore the safety and tolerability of the immediate switch from rasagiline (irreversible mao-b inhibitor) to safinamide, with the expectation that there will be no adverse events or increased risk of hypertensive crisis for patients with pd or signs of serotonin syndrome

objective: the aim of this study is to verify safety and tolerability of the immediate switch from rasagiline to safinamide trough monitoring of bp by 24-hour holter recording. the primary objective of the study will be achieved if the mean bp will not increase by \>10 mmhg in the studied population. methods: this is an open-label, single-centre study conducted at irccs san raffaele pisana. study population included patients with idiopathic pd in the mid-late stage of the disease, suffering from motor fluctuation, on stable treatment with rasagiline and levodopa (alone or in combination with other anti-parkinsonian medication). the protocol contemplates five visits during six weeks, with two 24-hour holter recording (first in rasagiline and second in first-day of safinamide therapy), monitoring typical symptoms of the serotonin syndrome.

Eligibility criteria:
inclusion criteria: * patients able to comprehend and provide consent form * patients with idiopathic parkinson's disease diagnosed according to the uk brain bank criteria * patients in mid-to late stage of the disease (hoehn \& yahr: between the stage 2 and 4 in on state). * patients suffering from motor fluctuations * patients must have a good response to levodopa in the opinion of the investigators (evaluated as improvement ≥ 30% of the updrs scores) * stable dosage of antiparkinsonian medication for at least 4 weeks prior to study enrollment * female patients in post-menopausal state; women of childbearing potential must use an acceptable method of contraception exclusion criteria: * atypical parkinsonism * any significant psychiatric, metabolic and systemic concomitant disease * patients with clinically significant out of range laboratory values * patients participating in a clinical trial in the last 6 weeks * patients with moderate-severe cognitive decline not able to provide consent form * patients currently lactating or pregnant or planning to become pregnant during the duration of the study * patients for whom xadago is contraindicated according to the current smpc

Keywords: imao-b safinamide rasagiline
estimate the safety and effectiveness of adjuvanted influenza vaccine among asian elderly people when compared to non-adjuvanted vaccines

Conditions: Influenza Vaccines; Elderly

Summary: to compare the immunogenicity, cellular immune response, and safety between adjuvanted (aiiv4) and non-adjuvanted (iiv4) seasonal influenza vaccines in the taiwanese elderly population with chronic medical conditions.

annual influenza vaccination is the most important and cost-effective intervention in reducing the impact of influenza, and a key component of the who response and preparedness efforts for influenza of pandemic potential. reduced effectiveness of conventional egg-based vaccination was observed among risk group, such as elderly and people on with chronic medical conditions, which may result from their impaired immunogenicity. who, as well as acip of the usa, europe, and australia suggested adjuvanted influenza vaccines as one of alternatives for those people, which could decrease the disease burden significantly in several analyses. an adjuvanted commercial vaccine has been approved in taiwan recently, but the local data of safety and effectiveness analysis is limited. this 1-year randomized control trial is designed to estimate the safety and effectiveness of adjuvanted influenza vaccine among asian elderly people when compared to non-adjuvanted vaccines.

Eligibility criteria:
inclusion criteria: * adults aged 65 years or above * presence of at least 1 chronic medical condition associated with increased risk of complicated influenza, including hypertension, chronic obstructive pulmonary disease (group a, b, e), asthma, congestive heart failure (acc/aha stage a, b, c, d), coronary arterial disease, diabetes mellitus, chronic liver disease (child-pugh score a, b, c) or chronic kidney disease (stage 1\~4), neuromuscular disorders, hematological or solid organ malignancies, recipient of hematopoietic stem cell transplantation or solid organ transplantation. exclusion criteria: * contraindications to influenza vaccination including history of severe adverse event after vaccination, such as anaphylaxis or guillain-barré syndrome, or a severe bleeding tendency * prior receipt of influenza vaccination during the current flu season. * determination by the principal investigator (pi) that the participant is ineligible for enrollment based on clinical assessment.

Keywords: influenza adjuvanted vaccine immunogenicity elderly safety
hyper-cvad treatment in lymphoblastic lymphoma

Conditions: Lymphoblastic Lymphoma

Summary: treatment outcomes of lymphoblastic lymphoma (lbl) have improved by the use of the regimens for acute lymphoblastic leukemia. hyper-cvad is one of the most effective treatments with high remission rate in acute lymphoblastic leukemia (all) and lbl. however, the treatment outcome of hyper-cvad in lbl has reported only in small number of patients from single institution. the investigators conducted this study to evaluate the hyper-cvad regimen based treatment in lbl.

we will analyze treatment outcome of lymphoblastic lymphoma patients treated with hyper-cvad regimen from 13 institutions in korea. in all patients, hyper-cvad was initial treatment. after achievement of response, patients either underwent hematopoietic stem cell transplantation (hsct) or consolidation with hyper-cvad.

Eligibility criteria:
inclusion criteria: * age over 18 at diagnosis * pathologically proven lymphoblastic lymphoma exclusion criteria: * proven hiv infection * pretreatment with other regimens

Keywords: adult lymphoblastic lymphoma hyper-cvad first-line treatment
brain hemorrhage and functional outcome in stroke patients with caa features on pre-thrombolysis mri treated with intravenous thrombolysis (thrombolysis in caa) ( thromb in caa )

Conditions: Hemorrhage; Cerebral Amyloid Angiopathy; Stroke

Summary: background: in stroke patients treated with intravenous thrombolysis (ivt), presence and high number of strictly lobar cerebral microbleeds (compatible with cerebral amyloid angiopathy, caa) seems to be associated with increased risk of hemorrhagic transformation, symptomatic hemorrhagic transformation, remote hemorrhage, and poor functional outcome. some of these reported caa patients with cerebral microbleeds also had chronic lobar intracerebral haemorrhage. few data is available on ivt-treated caa patients showing cortical superficial siderosis. there are no reports studying factors associated with brain hemorrhagic complication or functional outcome inside a group of ivt-treated caa patients. our aim was to evaluate brain hemorrhagic complications on 24h-ct and functional outcome after ivt in stroke patients with caa features on pre-ivt mri. methods: in our stroke center, ivt decision in patients with caa mri features is left at the discretion of the treating physician. we retrospectively screened pre-ivt imaging of 959 consecutive ivt-treated stroke patients (between january 2015 and july 2022) without ongoing anticoagulation therapy for probable caa mri features defined by modified boston criteria. after exclusion of 119 patients with lacking mri (n=47), with mri showing motion artefacts (n=49) or with alternative chronic brain hemorrhage cause on mri (n=23), 15 ivt-treated patients with probable caa on pre-ivt mri were identified. in these 15 patients, clinical, biological and mri characteristics were compared between patients with vs. without post-ivt hemorrhage and between patients with poor (mrs 3-6) vs. good (mrs 0-2) functional outcome at discharge.


Eligibility criteria:
inclusion criteria: * consecutive ivt-treated stroke patients without ongoing anticoagulation therapy registered in our stroke database presenting probable caa on pre-ivt mri * patient taken in charge at the chu of nîmes between january 2015 and july 2022 exclusion criteria: * patients with ongoing anticoagulation therapy

Keywords: functional outcome
assessment of neuropathic pain

Conditions: Spinal Cord Injury + Peripheral Nerve Diseases

Summary: development of neuropathic pain is one of the most disabling sequels after spinal cord injury (sci) and in peripheral nerve diseases. the functionality of the pain pathway in humans as well as its plastic changes following sci can be assessed in vivo by surface electrophysiological recordings and functional magnetic resonance imaging after noxious heat stimulation of the skin. aims: a) establishing a clinically applicable assessment of the pain pathway and characterizing its changes as a consequence of sci and in peripheral nerve diseases in an objective manner, b) characterizing plastic changes in the pain pathway in sci patients with neuropathic pain and in patients with peripheral nerve diseases and relating them to the development of neuropathic pain syndromes.


Eligibility criteria:
inclusion criteria: * uninjured * scord injured subjects * subjects with peripheral nerve diseases * patients resident in switzerland exclusion criteria: * presence of any central psychiatric disorder (that precludes subject from giving informed and voluntary consent) * for fmri measurements: "yes" for any item in the mr-risk questionnaire * patients resident outside from switzerland
study evaluating the safety and efficacy of c-chop in untreated subjects with angioimmunoblastic t cell lymphoma

Conditions: Angioimmunoblastic T-cell Lymphoma

Summary: this is a single-arm, open-label phase 2study of chidamide in combination with chop in the treatment of subjects with untreated angioimmunoblastic t cell lymphoma.

this open-label, single arm study will evaluate the efficacy and safety of chidamide in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (chop) chemotherapy in previously untreated subjects with angioimmunoblastic t cell lymphoma. subjects will receive 6 cycles of chidamide 20mg, day 1,4,8,11, orally (po) every 21 days, in addition to 6 cycles of chop chemotherapy iv every 21 days.

Eligibility criteria:
inclusion criteria: 1. pathologically confirmed angioimmunoblastic t cell lymphoma 2. treatment naive 3. age \> 18 years 4. must has measurable lesion in ct or pet-ct prior to treatment 5. ecog 0,1,2 6. informed consented exclusion criteria: 1. has accepted chemotherapy before 2. has accepted autologous stem cell transplantation before 3. history of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment 4. uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease 5. primary cns lymphoma 6. lvef≤50% 7. lab at enrollment (unless caused by lymphoma): neutrophile\ 2\*uln; akp or bilirubin \>1.5\*uln ;creatinine\>1.5\*uln 8. other uncontrollable medical condition that may that may interfere the participation of the study 9. not able to comply to the protocol for mental or other unknown reasons 10. pregnant or lactation 11. hiv infection 12. if hbsag positive, should check hbv dna, dna positive patients cannot be enrolled. if hbsag negative but hbcab positive (whatever hbsab status), should check hbv dna,dna positive patients cannot be enrolled.
intestinal inflammation in cf patients

Conditions: Cystic Fibrosis in Children; Cystic Fibrosis Gastrointestinal Disease; Cystic Fibrosis

Summary: cystic fibrosis (cf) is a disease that affects salt and water transport in multiple organs. many cf patients suffer from abdominal pain and this could be due to intestinal inflammation. however, so far we do not know how many of the cf patients actually do have intestinal inflammation when looking at intestinal specimens. there is a proven connection between chronic inflammation and developing colorectal cancer and over the years more cf patients are developing colorectal cancer. thus, it becomes increasingly important to look for the presence of intestinal inflammation in cf patients since early treatment may improve their symptoms and reduce the risk for colorectal cancer.

the aim is to determine the prevalence of intestinal inflammation by measurement of fecal calprotectin and/or histological evaluation of intestinal tissue biopsies in both pediatric and adult cf populations. pediatric cf population (age 10-18 years): 1. determine the prevalence of intestinal inflammation in a cohort of pediatric cf patients based on fecal calprotectin levels in stool samples. 2. assess the correlation between fecal calprotectin and abdominal symptoms/qol. adult cf population (age ≥ 18 years): 1. determine the prevalence of intestinal inflammation in a cohort of adult cf patients based on histological evaluation of intestinal tissues biopsies and fecal calprotectin levels in stool samples 1. in adult cf patients who have not undergone lung or liver transplantation. 2. in adult cf patients who have undergone lung or liver transplantation. 2. assess the correlation between fecal calprotectin and histological-proven intestinal inflammation in adult cf patients. 3. assess the correlation between histological-proven intestinal inflammation and abdominal symptoms/qol as well as the correlation between fecal calprotectin and abdominal symptoms/qol.

Eligibility criteria:
inclusion criteria ; pediatric cohort: 1. diagnosis of cf 2. informed consent obtained 3. age 10-18 years adult cohort: 1. diagnosis of cf 2. informed consent obtained 3. age ≥ 18 years 4. patient undergoing a colonoscopy for a clinical indication exclusion criteria ; pediatric cohort: 1. patients with the diagnosis of ibd. 2. patients during an episode of acute gastroenteritis or a pulmonary exacerbation. adult cohort: 1. patients with the diagnosis of ibd. 2. any health condition, e.g. coagulopathy, sepsis, severe bacterial colitis that would increase the risk for perforation or bleeding when taking intestinal tissue biopsies.
concurrent paclitaxel and radiotherapy after adjuvant doxorubicin and cyclophosphamide for stage 2 or 3 breast cancer

Conditions: Breast Cancer

Summary: the aim of this study is evaluation of the efficacy \& toxicity of concurrent paclitaxel and breast radiotherapy and assesment of overall survival \& progression free survival

over the recent years , breast cancer remains the most common cancer in women in the world . with nearly 107 million new cases diagnosed in 2012 (second most common cancer over all) . this represent about 12 % of all new cancer cases and 25 % of all cancers in women . by contrast the mortality rate has declined dramatically since the introduction of adjuvant systemic therapy \& radiation therapy, which are now used extensively for their established benefit in local (radiotherapy ) ,survival without metastasis (chemotherapy) and overall survival of both of them . however , the optimal sequence of chemotherapy \& radiotherapy remain controversial three sequence were investigated: 1. delivering all radiotherapy first . 2. a " sandwich " approach . 3. delivering all chemotherapy first . observational studies have suggested that delaying initiation of chemotherapy increase the incidence of distant metastasis \& delaying the initiation therapy more than 6 months after breast cancer diagnosis might increase risk of local regional recurrence . concurrent chemoradiation therapy has an advantage of shortening the duration of therapy , allowing radiotherapy \& chemotherapy to start temporally and potentially improving local control via radiation sensitizing effect of chemotherapy.the feasibility of concurrent radiotherapy with taxane, which constitute a standard treatment used as adjuvant therapy has been evaluated in stage ii,iii breast cancer. taxane promote stabilization of microtubules causing cell cycle arrest in g2/m junction and serve as radio sensitizing agents.in a prospective study using paclitaxel \& radiotherapy concurrently paclitaxel given every 3 weeks for 4 cycles the authors concluded that concurrent chemoradiation therapy improve local control with acceptable toxicity.

Eligibility criteria:
inclusion criteria : * • this study will include women aged 18 years \&older. * patients must be histologically diagnosed with breast cancer (ductal \& others). * patients who underwent conservative breast surgery \& modified radical mastectomy. * patients with stage ll\&lll breast cancer. * patients who received (ac) as adjuvant treatment . exclusion criteria: * patients with stage 1 or 4 breast cancer. * patients received adjuvant chemotherapy rather than (ac) . * patients with prior irradiation with thoracic region . * pregnancy or lactation . * patient with serious comorbid disease such as chronic obstructive pulmonary disease .