Kornimate/medical-research-clean huggingface dataset:
use of innovative and micro-invasive techniques for the early identification of breast cancer patients benefitting from neo-adjuvant therapy

Conditions: Breast Cancer

Summary: the purpose of the study is the identification of novel micro-invasive predictors of pathological complete response (pcr) during neo-adjuvant therapy

this is a single arm prospective, monocentric, open, experimental pilot study. the response to nac in breast cancer is extremely heterogeneous. the study and the identification of factors that can predict the response to treatment is therefore a priority, constituting a relevant "clinical unmet need".modern molecular biology techniques as well as imaging diagnostics could be valuable tools for characterizing the response to nac toward the definition of more personalized therapies.the prediction of therapy response after two cycle of chemotherapy rather than at the end of six cycles using non-invasive procedures will spare unwanted toxicity to the patients and resources to the regional and national health system. this study will also provide the patients, their familiar and all the stakeholders involved in the cure of breast cancer new important information regarding the management of breast cancer patients.this is a non-interventional study; therefore, the treatment will be as per physician choice according to the most appropriate therapeutic opportunities available for each patients' based on the type and stage of disease and the patients' performance status.currently, the nac regimens commonly used at cro-aviano for nac are epirubicine 90 mg/mq + ciclophosphamide 600 mg/mq d1 q21 or q14 (ec)(dose dense) followed by weekly paclitaxel 80 mg/mq for a total of 12 administrations. occasionally, due to patients and tumor features only weekly paclitaxel is used, and usually in this case up to 24 administrations may be given. only in the case of her2 positive bc trastuzumab 2 mg/kg is added to weekly paclitaxel. given the low response rate of hormone-based neoadjuvant therapy, only in rare cases (e.g. patients not amenable of surgery due to comorbidities), this approach is used.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. histological diagnosis of infiltrating breast cancer. 3. the presence of measurable mammary lesions; 4. the presence of metabolically active mammary lesions; 5. performance status (eastern cooperative oncology group scale, ecog) ≤ 1; 6. compliance with periodic blood withdrawal; 7. compliance with periodic pet/ct and rmn imaging; 8. adequate clinical and laboratory test results for undertaking neoadjuvant chemotherapy and surgery; 9. written informed consent. exclusion criteria: 1. the presence of contraindications for the execution of rmn and pet-tc; 2. presence of metastatic disease; 3. pre-existing or concurrent tumors, except in situ carcinoma or basophilic carcinoma of the skin; 4. uncontrolled active infections; 5. insufficient patient compliance; 6. absence of signed informed consent
brain lesions after transcatheter aortic valve replacement

Conditions: Aortic Valve Stenosis; Brain Diseases

Summary: the brain lesions after transcatheter aortic valve replacement (better) registry is a prospective, observational, multi-center registry aiming to assess the presence of new brain microbleeds assessed on susceptibility-weighted imaging at 3 enrolling sites, in china (west china hospital, sichuan university), uk (st thomas' hospital) and denmark (rigshospitalet, university of copenhagen). the main study arm is planned to include 100 patients with symptomatic severe aortic stenosis undergoing transfemoral tavr of any devices and 50 isolated bioprosthetic savr patients treated during the enrollment period as a control arm.

"silent" stroke post-tavr presents as asymptomatic brain ischemic lesions detected on diffusion-weighted magnetic resonance imaging (dw-mri), with an incidence ranging from 60% to 100% in different studies. on the contrary, hemorrhagic lesions are not systematically studied given the poor visualization of small hemorrhage (i.e. microbleeds) on traditional t1, t2 or dw-mri sequences. we have previously identified an incidence of new brain microbleeds early after tavr of 100% with the routine use of susceptibility-weighted imaging (swi). we hypothesize that new brain microbleeds are prevalent in patients with aortic stenosis after either tavr or savr. the key objective of this registry is to evaluate the incidence, distribution and clinical impact of new brain microbleeds after transfemoral tavr in patients with symptomatic severe aortic stenosis, in comparison with savr.

Eligibility criteria:
inclusion criteria: * symptomatic severe aortic stenosis (\>60 years old) being scheduled for either transfemoral tavr or isolated savr exclusion criteria: * patients who have been diagnosed with brain cancer, brain haemorrhage, brain abscess, aneurysm, cerebral palsy, encephalitis, nervous system infection, head or neurological injury, or trauma, stroke * contraindications for a magnetic resonance imaging (mri) scan (i.e. metallic implants, claustrophobia, mr-incompatible pacemakers or prosthetic heart valves) * unremovable dental prostheses that are deemed to affect mri quality * severe coronary artery disease that is unrevascularized * prior stroke within the last 12 months * expected non-compliance concerning follow-up examinations * have participated in other clinical trials

Keywords: tavr magnetic resonance imaging ischemic infarct microbleeds
metformin in pregnancy in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the study provide a detailed longitudinal evaluation of the gluco-insulinemic assessment of pregnant pcos women under metformin treatment. 47 non diabetic polycystic ovary syndrome (pcos) women became pregnant during metformin treatment and continued taking the drug during gestation. an oral glucose tolerance test and euglycaemic hyperinsulinaemic clamp were performed at each trimester of gestation.


Eligibility criteria:
inclusion criteria: * age 18-40 yr, * metformin treatment for at least 3 months before entering the pregnancy, * gestational age between 5 and 12 wk exclusion criteria: * diabetes mellitus * significant liver or renal impairment * neoplasms and other endocrine diseases * the use of drugs other than metformin able to interfere with glucose and insulin metabolism.
evaluation of the next generation watchman laa closure technology in non-valvular af patients (evolve)

Conditions: Atrial Fibrillation

Summary: this study will evaluate the next generation watchman left atrial appendage (laa) closure device as implanted in patients with non-valvular atrial fibrillation (af) with a chads2 stroke risk stratification score of 1 or greater. this is a prospective, non-randomized study to evaluate the initial use of the next generation watchman device.


Eligibility criteria:
key inclusion criteria: * paroxysmal, persistent, or permanent non-valvular atrial fibrillation * eligible for long-term warfarin therapy; * eligible to come off warfarin therapy if the laa is sealed * calculated chads2 score of 1 or greater key exclusion criteria: * new york heart association class iv congestive heart failure * recent mi (within 3 months) * asd and/or atrial septal repair or closure device * resting heart rate \>110 bpm * has an implanted mechanical valve prosthesis * left atrial appendage is obliterated * has undergone heart transplantation * has symptomatic carotid disease * contraindicated for aspirin * lvef \< 30% * cardiac tumor

Keywords: atrial fibrillation stroke warfarin coumadin tia trans ischemic attack
sedation level on machine learning with electroencephalogram in painless gastroenteroscopy patients

Conditions: Gastritis

Summary: painless endoscopy technology can make patients comfortable under anesthesia, but because of the painless inside.the diagnosis and treatment time of endoscopic examination is short, and the transport is fast. anesthesia related wind such as deep breathing depression and hypoxemia will occurrisks.eeg depth monitoring can assist anesthesiologists to evaluate the depth of anesthesia and reduce the risk. artificial intelligence is adopted.there are few reports on the evaluation of anesthesia depth and drug dosage by electroencephalogram (eeg) monitoring in outpatient patients with painless gastroenteroscopy.

1.examination, and establish brainclassification model of electrogram and sedation depth;2. the eeg characteristics, basic information and propofol were administered to all patients.the dose model of propofol painless gastroenteroscopy was established by machine learning to guide anesthesia drug use;3. evaluate the time and space complexity of the model, build the model, and assist the anesthesiologist to individualize the patient chemical, safe and comfortable management.

Eligibility criteria:
inclusion criteria: 1. painless gastroenteroscopy patients 2. asa classification is ⅰ-ⅱ 3. patients who are willing to cooperate 4. no schizophrenia,epilepsy and other neurological diseases exclusion criteria: 1. allergic to propofol 2. patients who are unwilling to cooperate 3. patients with psychiatric disorders 4. patients using sedative drugs for a long time 5. patients with neuropsychiatric disorders 6. patients with severe heart, liver, kidney and respiratory diseases

Keywords: deep sedation machine learning eeg characheristics; painless gastroscopy
efficacy and safety study of combigan and 0.5% timoptic in normal tension glaucoma

Conditions: Normal Tension Glaucoma

Summary: purpose to evaluate efficacy and safety of combigan(brimonidine/timolol) and 0.5% timoptic (timolol) ophthalmic solutions in normal tension glaucoma patients.

* normal tension glaucoma (ntg) is the major type of glaucoma in korea. (over 90% of glaucoma type) * brimonidine (selective alpha 2 adrenergic agonist): neuroprotection effect by suppression of aqueous humor production and increasement of uveoscleral outflow * timolol (non selective beta blocker): suppression effect of aqueous humor production * combigan (fixed combination of brimonidine \& timolol): more lowering effect of intraocular pressure and enhancing the compliance of glaucoma patients

Eligibility criteria:
inclusion criteria: * over 18 years old * baseline iop under 22 mmhg,both anterior chamber angle \> grade 3\~4 by shaffer grading system exclusion criteria: * iop over 22 mmhg by goldmann applanation tonometer * other types of glaucoma except open angle * other iop lowering treatment * chronic or recurrent hx. of ocular inflammation * using contact lens * any other ocular disease that could affect visual field examination (diabetic retinopathy, macular disease, uveitis, scleritis, optic neuritis, anterior ischemic optic neuropathy) * intraocular or glaucoma surgery within 6 months * hx. of allergic reaction to timolol or brimonidine * bronchial asthma * moderate to severe chronic obstructive pulmonary disease * heart failure * 2\~3 degree a-v block, * mao inhibitor use * anti depressant use * untreated pheochromocytoma * pregnant

Keywords: normal tension glaucoma antiglaucoma ophthalmic solution brimonidine timolol combination drugs
effects of high fruit, vegetable, and dairy intake on plasma lipids and blood pressure in healthy individuals

Conditions: Cardiovascular Disease; Dyslipidemia; Blood Pressure

Summary: the dietary approaches to stop hypertension (dash) trial has been shown to reduce blood pressure and plasma total and ldl-cholesterol (c) compared to a western diet, but shows no benefit on other blood lipid variables associated with cardiovascular disease (cvd) risk, namely hdl-cholesterol and triglycerides. the overall objective of this study is to determine whether modification of the dash diet by substituting carbohydrate with fat will result in improvements in multiple biomarkers of cvd risk. specifically, the investigators will test the hypotheses that modification of the dash diet by reducing carbohydrate, primarily in the form of simple sugars and glycemic starches, and allowing for a more liberal intake of total and saturated fat, primarily from dairy foods, will: (1) improve lipoprotein markers of cvd risk (reduced total/hdl-c ratio, apolipoprotein b, small ldl particles, and increased hdl-c, apoai, and large hdl particles); and (2) result in comparable reductions of systolic and diastolic blood pressure to those achieved with the standard dash diet. the investigators will also assess the effects of the modified dash diet on markers of insulin resistance and inflammation. our main hypotheses will be tested by a controlled dietary intervention conducted in 40 healthy men and women who will be randomly allocated to consume, for 3 weeks each, a control western diet, a standard dash diet, and a modified low-carbohydrate dash diet, separated by 2-week washout periods.


Eligibility criteria:
inclusion criteria: * age 22 years and older * average systolic blood pressure \<160 mm hg and diastolic blood pressure 80 - 95 mm hg measured on 2 separate days * non-smoking * agrees to abstain from alcohol and dietary supplements during the study * willing to consume all study foods as instructed exclusion criteria: * history of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, hiv, or cancer (other than skin cancer) in the last 5 years. * taking hormones or drugs known to affect lipid metabolism or blood pressure. * body mass index (bmi) \> 35 * total- and ldl-cholesterol \> 95th percentile for sex and age. * fasting triglycerides \> 500 mg/dl. * fasting blood sugar (fbs) \> 126 mg/dl. * abnormal thyroid stimulating hormone * not weight stable * pregnant or breast-feeding

Keywords: carbohydrate dash diet blood pressure cholesterol
treating intraoperative bradycardia in non-cardiac surgery patients with atropine at heart rates below 60 versus 30 beats per minute and norepinephrine requirements

Conditions: Intraoperative Bradycardia

Summary: the rapid trial is a randomized, single-center trial investigating whether giving atropine at heart rates below 60 beats per minute versus giving atropine only at heart rates below 30 beats per minute reduces the amount of norepinephrine needed to keep map above 65 mmhg in non-cardiac surgery patients with intraoperative bradycardia.


Eligibility criteria:
inclusion criteria: consenting patients ≥50 years scheduled for elective non-cardiac surgery with general anesthesia that is expected to last ≥60 minutes with at least two of the following risk criteria for developing acute kidney injury: * age ≥65 years * american society of anesthesiologists physical status iii or iv * chronic arterial hypertension * diabetes mellitus requiring medication * intraabdominal surgery * preoperative renal insufficiency (serum creatinine ≥1.2 mg/dl) exclusion criteria: patients with the following exclusion criteria: contraindication for atropine administration (e.g., myasthenia gravis, high-grade aortic stenosis, high-grade coronary artery disease, glaucoma, paralytic ileus, prostatic hypertrophy); renal replacement therapy within the previous 3 months; chronic kidney disease with an estimated glomerular filtration rate \<20 ml/min/1.73 m2; pregnancy.
clinical outcome of extracorporeal shock wave therapy in patient with axillary web syndrome

Conditions: Axillary Web Syndrome; Breast Cancer; Lymphedema; Extracorporeal Shock Wave Therapy

Summary: axillary web syndrome(aws) is common complication of breast cancer surgery. overall, aws affects more than a half of the patient receiving axillary lymph node dissection. the symptoms of aws include pain, limited function and range of motion. geater risk of secondary lymphedema was found if the patient developed aws during the first postoperative year. eswt was used for treating myofascial pain for decades. low energy eswt combined with complex decongestive therapy had a benefit on shoulder joint rom and skin thickness improvement in patients with bcrl in recently studies. investigators wonder if eswt can also be applied to patients with axillary web syndrome for increasing rom and relieving pain. the aim of this study was to evaluate the therapeutic effects of low energy eswt in patients with axillary web syndrome.


Eligibility criteria:
inclusion criteria: 1. axillary web syndrome patient 2. unilateral breast cancer and received related operation(mastectomy/alnd/slnd) 3. completion of beast related chemotherapy or radiotherapy 4. age with 20-65 years old exclusion criteria: 1. ongoing metastasis or recurrence of the breast cancer 2. other cancer history 3. lymphatic transplantation or reconstruction 4. wound, infection or trauma over affected arm 5. coagulopathy or poor circulation 6. pregnancy 7. oral anticoagulant using
comparison of the time to the first rescue analgesic among parturients receiving intrathecal additive fentanyl or intrathecal fentanyl with tap block or tap block alone for elective cesarean sections under hyperbaric bupivacaine spinal anesthesia

Conditions: Postoperative Pain; Cesarean Section

Summary: the postoperative pain management after cesarean section under spinal anestheisa is done using various modalities. the commonly used regimens are systemic nsaids/opioids, usg guided tap block or intrathecal additive fentanyl or combined intrathecal fentanyl and usg guided tap block. investigators aim to compare the postoperative analgesia in terms of time to the first rescue analgesic in parturients receiving intrathecal additive fentanyl only, or intrathecal fentanyl with usg guided tap block or usg guided tap block alone for elective cs done under hyperbaric bupivacaine spinal anesthesia.

investigators will enroll 93 parturients planned for elective cs under hyperbaric bupivacaine spinal anesthesia and allocate them into three groups comprising intrathecal additive fentanyl only, or intrathecal fentanyl with usg guided tap block or usg guided tap block alone. the primary outcome will be time to the first rescue analgesics.

Eligibility criteria:
inclusion criteria: * american society of anesthesiology(asa) physical status ii * able to read and understand the information sheet and to sign and date the consent form * scheduled for elective cs planned with spinal anesthesia * gestational age \> 37 weeks and \< weeks assessed on the dating scale. exclusion criteria: * complicated pregnancy; defined as having preeclampsia or placenta accreta,increta and percreta * opioid addiction or dependence * contraindications to tap block( ski infection, abdominal wall muscle defects) * allergy to any medications used in the study * case converted to general anesthesia * cases who develop postoperative hemorrhage, amniotic fluid embolism
potential adverse developmental and nutritional consequences of helicobacter pylori infection in israeli children

Conditions: Helicobacter Pylori Infection; Iron Deficiency Anemia; Child Development

Summary: the investigators believe that there is an association between h. pylori infection and nutritional status and between h. pylori infection and cognitive development. the current study will examine this association in israeli children, aged 6-12 years.


Eligibility criteria:
inclusion criteria: * informed consent by parents/guardians and children exclusion criteria: * growth retardation history * history of prior therapy for h. pylori irradiation * hematological disorders * developmental delays
kinetics, efficacy and safety of ivig-l in hypogammaglobulinemia patients

Conditions: Hypogammaglobulinemia

Summary: the kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, ivig-l, were studied in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy.

sanquin has developed, in cooperation with the finnish red cross blood transfusion service (frcbts), a liquid intravenous immunoglobulin product, ivig-l. the liquid formulation of intravenous immunoglobulin simplifies the infusion, eliminates possible mistakes in the reconstitution with water for injections and reduces the space requirements in storage. in addition to the donor selection and donor screening, several viral safety steps have been included into the production process. in this clinical trial, the efficacy and safety of ivig-l in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy, will be studied. ivig-l will also be studied in patients with chronic itp (kb98001). data from both studies will be used for an application for marketing authorisation in finland and the netherlands.

Eligibility criteria:
inclusion criteria: * primary a- or hypogammaglobulinemia, particularly patients with x-linked agammaglobulinemia (xla) or common variable immunodeficiency (cvid) * used to replacement treatment with intravenous immunoglobulin with 2-4 week intervals * a stable clinical situation (no activity of any other disease; a stable immunoglobulin dose) * age \> 18 years * the patient/legally acceptable representative has signed the consent form exclusion criteria: * treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study * known allergic reactions to human plasma or plasma products * have an ongoing progressive terminal disease, including hiv infection * pregnancy or lactation * known insufficiency of coronary or cerebral circulation * have renal insufficiency (plasma creatinine \> 115µmol/l) * have an ongoing active disease causing general symptoms, e.g. chronic active hepatitis, persistent enterovirus infection. * have iga deficiency, and anti-iga antibodies have been detected * active systemic lupus erythematosus (sle)

Keywords: agammaglobulinemia hypogammaglobulinemia immunoglobulins, intravenous