Kornimate/medical-research-clean huggingface dataset:
a safety and tolerability study of vc-02™ combination product in subjects with type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this trial is to test if vc-02™ combination product can be implanted subcutaneously in subjects with type 1 diabetes and maintained safely for up to four (4) months.


Eligibility criteria:
inclusion criteria: * men and non-pregnant women of non-childbearing potential * diagnosis of t1dm for a minimum of five (5) years * stable diabetic treatment * willingness to use a continuous glucose meter * acceptable candidate for implantation exclusion criteria: * history of islet cell, kidney, and/or pancreas transplant. * two (2) or more severe, unexplained hypoglycemic events within six (6) months of enrollment * uncontrolled or untreated thyroid disease or adrenal insufficiency * diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy * non-compliance with current anti-diabetic regimen
magnetic resonance post-contrast vascular hyperintensities at 3 t: a sensitive sign of vascular occlusion in acute ischaemic stroke

Conditions: Acute Ischaemic Stroke

Summary: magnetic resonance imaging (mri) is the diagnostic cornerstone for precisely identifying acute ischaemic strokes and locating vascular occlusions. it was observed that a post-contrast three-dimensional turbo-spin-echo t1weighted sequence showed striking post-contrast vascular hyperintensities (pcvh) in ischaemic territories. the aim is to evaluate the prevalence and the meaning of this finding. this study included 130 consecutive patients admitted for acute ischaemic stroke with a 3-t mri performed in the first 12 h of symptom onset from september 2014 through september 2016. two neuroradiologists blinded to clinical data analysed the first mri assessments.


Eligibility criteria:
inclusion criteria: * patients aged 18 and older at onset of an acute ischaemic stroke * availability of at least one pre-therapeutic mri performed in our centre within 12 h of stroke onset, including a post-contrast 3d tse t1-weighted sequence. exclusion criteria: * patients with posterior fossa strokes * patients with known intracranial vasculitis or moyamoya disease * presence of severe mr imaging artefacts preventing correct interpretation

Keywords: cerebrovascular disorders magnetic resonance imaging neuroimaging prognosis stroke
anti-snoring appliances and airway manipulation in patients undergoing anesthetic sedation

Conditions: Airway Obstruction; Snoring; Sedation Complication

Summary: would patients using an anti-snoring appliance intraoperatively require less airway manipulation, interventions, and rescue maneuvers during anesthetic sedation cases compared to those who do not? the investigators will use anti-snoring appliance devices (specifically the fda approved zyppah) to attempt to relieve tissue obstructions that cause snoring during sleep. the application of the devices to the body is less invasive than other common intraoperative rescue airway devices (e.g. nasal trumpets and oral airways) which are not designed to be patient specific.


Eligibility criteria:
inclusion criteria: * adult patients (age 18-89 years old) * undergoing procedures below the umbilicus requiring anesthetic sedation without an invasive airway * a stop-bang (survey) score of 2 or greater. exclusion criteria: * patients who are unable to consent * non-english speaking * those requiring general anesthesia.

Keywords: airway obstruction snoring monitored anesthesia care intravenous sedation
a retrospective, observational study to collect clinical safety and performance data of polymaille® extra thin vascular prothesis

Conditions: Aneurysm Abdominal; Peripheral Aneurysms; Arterial Disease Occlusive; Prothesis

Summary: the purpose of this pmcf study is to evaluate a minimum of 125 subjects in 1 or 2 sites in france at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease. the objectives of the evaluation will describe safety and performance of polymaille® extra thin.


Eligibility criteria:
inclusion criteria: * patients must meet all the following inclusion criteria in order to be eligible for inclusion in the study: patient has a minimum of 1-year post-operative follow-up data available, or complete data to death exclusion criteria: * patients who refused the collection of their personal data.
a study to investigate safety, tolerability and pharmacokinetics of single and repeat doses of chf6333 in healthy subjects

Conditions: Non-Cystic Fibrosis Bronchiectasis; Cystic Fibrosis

Summary: human neutrophil elastase (hne) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases. chf 6333 is a potent and 24h-durable inhibitor of hne, developed as dry powder inhaler (dpi) formulation. this study is designed to investigate the tolerability, safety and pharmacokinetics of inhaled chf6333 dpi in healthy male subjects. the study will comprise two parts: part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending dose (sad) of chf6333. part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of multiple ascending dose (mad) of chf6333


Eligibility criteria:
inclusion criteria: * male subjects aged 18-55 years * bmi between 18-30 kg/m2 * non smokers * lung function above 80% of predicted normal value * healthy subjects based on medical evaluation including medical history, physical examination, laboratory tests and cardiac testing exclusion criteria: * any clinically relevant abnormalities and/or uncontrolled diseases * abnormal laboratory values * recent respiratory tract infection * hypersensitivity to the drug or excipients * positive serology results * positive cotinine, alcohol, drug of abuse tests * unsuitable veins for repeated venepuncture
study of bacteria on mood and bowel symptoms in patients with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome; IBS

Summary: the purpose of this study is to determine whether probiotic bacterium bifidobacterium longum (b. longum) can improve mood and bowel symptoms in patients with irritable bowel syndrome (ibs). the patients will be treated with probiotic or placebo for 6 weeks. their mood, memory, general well-being and bowel symptoms will be assessed before, at the end of the treatment and 4 weeks later. brain activation pattern, changes in gut bacteria, metabolic profile and inflammatory markers will be also measured.


Eligibility criteria:
inclusion criteria: * diagnosis of irritable bowel syndrome based on rome iii criteria * symptoms of mild to moderate anxiety and depression exclusion criteria: * concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection. * concurrent organic gastrointestinal (gi) pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli. * psychiatric diagnosis other than anxiety or depression. * patients treated with therapeutic/standard doses of antidepressants and/or anxiolytics * history of active cancer in the last 5 years, other than skin basal cells cancer * pregnant or breastfeeding women * treatment with antibiotics during the three months prior the study. * known or suspected allergies to the study products (eg maltodextrin). * patients who have heart pacemakers, metal implants, metal chips or clips in or around the eyeballs, artificial heart valves, metallic ear implants, bullet fragments or fixed brackets. * high fiber diet (\>35 g/day for males, \> 25 g/day for females), consumption of high inulin containing foods (\>5 g/day). * consumption of any type of yoghurts or probiotic-containing products in the 4 weeks prior to the beginning of the study.
the accuracy of sentinel node biopsy of breast cancer with sonographic abnormal axillary lymph nodes

Conditions: Breast Cancer

Summary: * this is a phase ii, prospective, single-center, non-randomized, non-controlled study. * sentinel lymph node biopsy (snb) is a standard staging procedure in early breast cancer. the potentially increasing false negative rate of snb was concerned if the sonographic abnormal node was not excised. the aim of this study was to evaluate the accuracy of snb in breast cancer with sonographic abnormal axillary lymph nodes.


Eligibility criteria:
inclusion criteria: * histologically confirmsed primary breast cancer by core neelde biopsy or excisional biospy * abnormal axillary lymph node was found by ultrasound examination before slnb (abnormal nodes were defined as completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation and cortical thickness \>3mm) * ultrasound-guided fna cytology of these nodes were performed * the result of fna cytology was negative (no tumour cell was found) * patient planed to perform slnb exclusion criteria: * pathological diagnosed ductal carcinoma in situ by excisional biospy * abnormal axillary lymph node was found by ultrasound examination but fna cytology of these nodes were not performed * the result of fna cytology was positive (tumour cell was found) * t4d tumour * patient has recieved neo-adjuvant system therapy

Keywords: breast cancer sentinel lymph node biopsy ultrasonography fine needle aspiration
timing of carbetocin administration in postpartum hemorrhage

Conditions: Postpartum Hemorrhage; Carbetocin

Summary: postpartum haemorrhage (pph) is one of the major contributors to maternal mortality and morbidity worldwide. active management of the third stage of labour has been proven to be effective in the prevention of pph. syntometrine is more effective than oxytocin but is associated with more side effects. carbetocin, a long-acting oxytocin agonist, appears to be a promising agent for the prevention of pph. the use of carbetocin, being an important agent in the prevention of pph, also increases its prevalence. it is planned to investigate the advantages and disadvantages of the timing of its use.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * vaginal delivery at or beyond 38 weeks of gestation * primipar exclusion criteria: * multiparity * contraindications to carbetocin use (e.g., pre-existing hypertension, pre-eclampsia,asthma, cardiac, renal, or liver disease) * high-risk factors for primary postpartum hemorrhage, including grand multiparity,presence of uterine fibroids, or a need for prophylactic oxytocin infusion * anemia or * body mass index (bmi) over 35 * baby weight over 4000 grams * comorbidities or chronic diseases * history of curettage * use of propess or oxytocin during labor

Keywords: postpartum hemorrhage pph carbetocin placental retention
observational study of low dose fcr in elderly/comorbid cll/sll: the q-lite project

Conditions: Chronic Lymphocytic Leukemia

Summary: fcr (fludarabine, cyclophosphamide, rituximab) combination is currently accepted as the gold standard in treatment of younger and physically fit cll patients. these excellent results, however, cannot be generally applied to the whole cll population. this is because the median age at diagnosis of cll lies between 65 and 72 years and patients older than 65 years in fact account up to 50%-75 % of the cll population. nevertheless, such population is considerably underrepresented in most of the large clinical trials in cll/sll. therefore, it is not clear whether elderly/comorbid patients could profit from newer treatment approaches such as purine analog combinations or chemoimmunotherapy. several publications demonstrated unacceptable toxicity of full-dose fc/fcr in elderly cll patients. however, regimens using attenuated doses of fludarabine and cyclophosphamide showed promising efficacy and low toxicity.

the objective of this observational study is to provide additional data to confirm the safety profile and efficacy of low dose fcr for cll patients treated in clinical practice. specific data of interest are: comorbid concitions, concomitant medication, cll characteristics, prior treatment regimens, adverse events, reasons for discontinuation low dose fcr, overal response rates, complete response rate, progression-free survival, overall survival. this is an observational, non-interventional, medical record review study in cll patients. a total of 200 patients with cll who have been previously treated with low dose fcr will be eligible for the study.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cll or sll * previously treated by low dose fcr for active disease requiring treatment per iwcll criteria * dose reduction of fludarabine and cyclophosphamide due to age, comorbid conditions, or reduce creatinine clearance exclusion criteria: * patients treated with low dose fcr within prospective clinical trials

Keywords: chronic lymphocytic leukemia fludarabine rituximab elderly comorbid fcr cirs
salvage chemotherapy of vinorelbine plus oxaliplatin in metastatic triple-negative breast cancer:a prospective trial

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of vinorelbine plus oxaliplatin in pretreated metastatic triple-negative breast cancer.

triple-negative breast cancer is associated with less treatment choices and shorter overall survival. both vinorebine and oxaliplatin are effective in metastatic breast cancer. the investigators designed this trial to evaluate the combination of these two drugs in pretreated metastatic triple-negative breast cancer.

Eligibility criteria:
inclusion criteria: 1. females with age between 18 and 70 years old 2. ecog performance between 0-2 3. life expectancy more than 3 months 4. histological proven unresectable recurrent or advanced breast cancer 5. triple-negative for estrogen receptor (er), progestogen receptor (pr), and human epithelial receptor-2 (her2) by immunohistochemistry (ihc) test. for patients with er negative, pr negative, her2 two plus, a negative her2 gene amplification should be verified with fish test. her2 one plus may consider fish verification. 6. no more than 2 chemotherapy for metastatic breast cancer. 7. at least one measurable disease according to the response evaluation criteria in solid tumor (recist1.1) 8. no anticancer therapy within 4 weeks 9. no neuropathy more than grade i 10. adequate hematologic, hepatic, and renal function,no serious medical history of heart, lung, liver and kidney 11. provision of written informed consent prior to any study specific procedures exclusion criteria: 1. pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound) 2. women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study 3. treatment with an investigational product within 4 weeks before the first treatment 4. symptomatic central nervous system metastases 5. other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia. 6. patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions 7. uncontrolled serious infection 8. previous administration of vinorelbine 9. patients with bad compliance

Keywords: metastatic triple-negative breast cancer vinorebine oxaliplatin
cohort study of heart failure with preserved ejection fraction in chinese han

Conditions: Heart Failure

Summary: to analyze factors contributing to the development and prognosis of heart failure with preserved ejection fraction.

based on previous studies on development of heart failure with preserved ejection fraction (hfpef), racial/ethnical background should be underscored when evaluating risk f actors for hfpef incidence. as the ageing population increases sharply in china, hfpef represents the dominant phenotype of all patients diagnosed with heart failure. in this cohort study, the investigators evaluated exposures or risk factors for hfpef in chinese han patients with cardiovascular diseases (cvd). our study may provide preventive and therapeutic targets for hfpef in chinese cvd patients.

Eligibility criteria:
inclusion criteria: * patients with cvd, defined as at least one diagnosis of coronary heart disease, hypertension, type 2 diabetes or cardiomyopathy. the definition of coronary heart disease was stenosis of the main coronary arteries ≥ 50% using percutaneous coronary angiography or coronary computed tomography angiography findings. the definition of hypertension was systolic blood pressure ≥ 140 mmhg, diastolic blood pressure ≥ 90 mmhg or pharmacological treatment. the definition of type 2 diabetes was fasting blood glucose ≥ 7.0 mmol/l, random blood glucose ≥ 11.1 mmol/l and hba1c \> 6.5% or the or the use of hypoglycaemic medications. cardiomyopathy was defined as the presence of cardiac insufficiency in patients with dilated cardiomyopathy suggested by percutaneous coronary angiography or coronary ct angiography use of hypoglycaemic medications. exclusion criteria: * primary diagnoses of atherosclerosis (stenosis of the main coronary arteries \< 50%), congenital heart diseases, arrhythmia, lung diseases, aortic dissection, peripheral vascular diseases, pericardial diseases, myocarditis, hypertrophic cardiomyopathy, heart valvular diseases, cardiophobia, costal chondritis, shock, thyroid diseases, infection or concomitant liver or renal dysfunction.

Keywords: cardiovascular diseases; diastolic dysfunction;systolic dysfunction; heart failure; risk factor
pomalidomide (pom) in combination with low dose dexamethasone (ld-dex) in patients with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: to provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available

several clinical studies indicate that pomalidomide has activity in relapsed and refractory multiple myeloma with response rates ranging between 30% and 60% at pomalidomide doses at 2 mg/day and/or 4 mg/day.

Eligibility criteria:
inclusion criteria: 1. must have documented diagnosis of relapsed or relapsed/refractory multiple myeloma and have measurable disease (serum or urine m-protein) 2. age ≥ 18 years 3. must have had at least ≥ 2 prior anti-myeloma therapies 4. must have received at least 2 consecutive cycles of both lenalidomide and bortezomib, either alone or in combination 5. must have failed treatment with the last lenalidomide-containing regimen and the last bortezomib-containing regimen 6. must have documented disease progression during or after the last antimyeloma regimen 7. females of childbearing potential (fcbp) must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting drug, while participating in the study and for at least 28 days after study treatment discontinuation. 8. males must agree to use a latex condom during sexual contact with fcbp while participating in the study and for 28 days following discontinuation from study treatment. exclusion criteria: 1. peripheral neuropathy ≥ grade 2 2. non-secretory multiple myeloma 3. previous therapy with pomalidomide 4. use of any investigational agents within 28 days or 5 half lives (whichever is longer) of initiating study treatment 5. subjects with conditions requiring chronic steroid or immunosuppressive treatment. 6. hypersensitivity to thalidomide, lenalidomide or dexamethasone 7. known human immunodeficiency virus positive, active or chronic hepatitis a, b or c 8. pregnant or breastfeeding females 9. unacceptable hematological or biochemical laboratory abnormalities

Keywords: relapsed refractory multiple myeloma pomalidomide
conversion therapy of ras/braf wild-type right-sided colon cancer patients with initially unresectable liver metastases

Conditions: Colorectal Cancer; Liver Metastases

Summary: the prognosis of patients with metastatic right-sided colon cancer is worse than that of patients with metastatic left-sided cancer. different guidelines have different recommendations on specific conversion therapy for colorectal liver metastases. the united states nccn guidelines do not recommend standard chemotherapy combined with anti egfr monoclonal antibody for patients with right colon cancer. the european esmo guidelines recommend that patients with ras / braf wild-type right-sided colon cancer should first consider three drugs ± bevacizumab, but considering the objective response rate results, standard chemotherapy + anti egfr monoclonal antibody is still one of the choices. china csco guidelines recommend standard chemotherapy ± bevacizumab, and also recommend standard chemotherapy + cetuximab for patients with right-sided colon cancer. therefore, the targeted therapy for ras / braf wild-type metastatic right colon cancer is still controversial. therefore, we are ready to carry out the clinical trial of cetuximab and bevacizumab in conversion therapy for ras / braf wild-type metastatic right colon cancer. the conversion resection rate is the primary point, and the objective response rate, perioperative safety and long-term survival are the secondary points.


Eligibility criteria:
inclusion criteria: 1. the primary tumor was confirmed by histology as colorectal adenocarcinoma 2. primary right-sided colorectal adenocarcinoma 3. radiologic evidence suggests that the initial unresectable liver metastases 4. ras/braf gene wild-type states 5. ecog was 0 \~ 1 6. life expectancy ≥ 3 months 7. good hematological function: neutrophil ≥ 1.5x109/l and platelet count ≥ 100x109 / l; hb ≥ 9g / dl (within one week before randomization) 8. normal liver and kidney function: serum bilirubin ≤ 1.5x normal upper limit (uln), alkaline phosphatase ≤ 5x uln, serum transaminase (ast or alt) ≤ 5x uln (within one week before randomization); 9. sign the written informed consent to participate in the experiment exclusion criteria: 1. patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy 2. known or suspected extrahepatic metastasis 3. patients with known hypersensitivity to any component of the study treatment 4. clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range 5. acute or subacute intestinal obstruction 6. pregnancy (no pregnancy confirmed by serum / urine β - hcg) or breastfeeding. 7. she had other malignant tumors within 5 years, except for those with skin basal cell carcinoma or cervical cancer 8. known drug / alcohol abuse 9. no legal capacity or limited legal capacity 10. there is peripheral neuropathy

Keywords: cetuximab bevacizumab liver metastases colorectal cancer right-sided