Kornimate/medical-research-clean huggingface dataset:
rule-based closed loop system for type 1 diabetes control

Conditions: Type 1 Diabetes

Summary: the aim of the study is to assess the efficacy and safety of a rule-based closed loop system, using subcutaneous way, for the overnight and prandial glucose control in type 1 diabetic subjects. ten subjects will be enrolled and they will participate in a cross-over study with a control night, using their usual insulin pump pattern, and with a experimental night, being controlled for the closed loop system. each night includes the overnight control and prandial control of the breakfast. the system proposes an insulin dose every 5 minutes according with the value of glucose displayed by the continuous glucose monitoring system.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * insulin pump treatment * undetectable c-peptide exclusion criteria: * autonomous system neuropathy
in.pact global clinical study

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to collect safety and efficacy data on the in.pact admiral™ drug eluting balloon (deb) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

peripheral artery disease (pad) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. progression of pad can result in critical limb ischemia (cli), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death. the in.pact global clinical study aims to expand and understand the safety and efficacy data on the in.pact admiral™ deb in a real world population of subjects with intermittent claudication and/or rest pain (rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.

Eligibility criteria:
general inclusion criteria: * age ≥ 18 years or minimum age as required by local regulations. * subject with documented diagnosis of peripheral arterial disease (pad) in the superficial femoral artery (sfa) and/or popliteal artery (pa) (including p1, p2, p3) classified as rutherford class 2-3-4. * angiographically documented single or multiple lesions/occlusions (de novo or re-stenotic lesion(s) or in-stent restenosis) within the target vessels with a minimum lesion length of 2 cm including bilateral disease if both limbs are treated within 35 days. general exclusion criteria: * high probability of non-adherence to clinical investigation protocol follow-up requirements. * failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations). * lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm.

Keywords: peripheral arterial disease drug coated balloon superficial femoral artery popliteal femoral artery atherosclerosis drug eluting balloon
physicians international ct utilization registry 2

Conditions: Coronary Artery Disease

Summary: to determine the total plaque burden, plaque severity and composition of patients undergoing cardiac ct who do not have any previous history of cvd. there are two cohorts: 1. a retrospective follow-up for mace endpoints of patients who underwent a ccta \>1 year ago as part of the big picture trial, who meet the inclusion criteria of big picture 2. 2. a prospective observational registry of patients referred to undergo ccta with a 1 and 2 year follow-up.

in the original big picture trial, the analysis of over 6000 subject's ccta images found significant differences amongst patients of arabic and south-east asian descent, with regard to plaque burden, severity and composition. due to the "all-comers" nature of that trial, the factors of diabetes, previous cvd, and other coronary risk factors were likely confounders in the results. in this trial, those subject selection is screened to eliminate those factors with the goal of working with a more homogenous population to perform the plaque analysis. this study is a multicenter, prospective, post marketing, observational registry study designed to describe frequency and patterns of various risk factors, indications and findings in patients who undergo ccta. big picture 2 (abbreviated as "bp2") will collect data on patients from a wide variety of imaging sites (inpatient, outpatient, in-clinic ct machine). while the majority of the sites are within the us, the data collection will not be limited to us-only sites. a sub study of bp2 will perform a remote short follow-up questionnaire of subjects who were in the original big picture study.

Eligibility criteria:
subject inclusion criteria * 18 years or older * no prior cvd * no hypertension * no diabetes * body mass index (bmi) \<35 kg/m2. subject exclusion criteria * \<18 years or older * prior cvd * hypertension * body mass index (bmi) \>=30 kg/m2. * diabetes mellitus type 1 or 2 * current or previous history of smoking * pregnancy * planned intervention or bypass surgery * known complex congenital heart disease * planned invasive angiography for reasons other than cad * non-cardiac illness with life expectancy \< 2 years * inability to provide written informed consent * concomitant participation in another clinical trial in which subject is subject to investigational drug or device * pregnant women * allergy to iodinated contrast agent * serum creatinine \>1.5 mg/dl or gfr \<30 ml/min * baseline irregular heart rhythm * heart rate ≥100 beats per minute * systolic blood pressure ≤90 mm hg * contraindications to β blockers or nitroglycerin strategies for recruitment and retention
assessment of the efficacy and safety of a new medical device in the local treatment of diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: evaluation of the efficacy and safety of a device with lu3103209 compound versus the same device, free of lu3103209 compound, in the local management of dfus.

a european prospective, randomized, double-blind, multicentre, clinical trial, conducted in three parallel groups, to evaluate the efficacy and safety of a device with lu3103209 compound versus the same device, free of lu3103209 compound, in the local management of diabetic foot ulcers (dfus).

Eligibility criteria:
inclusion criteria: 1. male or female over 18 years old who has provided his/her written informed consent 2. patient with type 1 or type 2 diabetes mellitus with glycated haemoglobin (hba1c) level ≤ 10% 3. inpatient or outpatient who can be monitored by the same investigating team throughout the entire study 4. patient who agrees to wear an off-loading system during the trial 5. diagnosis of peripheral neuropathy 6. patient with an adequate arterial perfusion of the affected limb, confirmed by abpi and toe blood pressure assessment 7. dfu grade 1-a or 2-a or 1-c or 2-c as defined by the university of texas diabetic wound classification system 8. target dfu surface area between 1 cm² to 10 cm², after debridement 9. dfu present since less than 24 months exclusion criteria: a. pregnant or breast-feeding woman or woman of childbearing potential not protected by an effective contraceptive method of birth control b. patient who participated in another clinical trial in the previous month or who will take part in another clinical trial during the 12 weeks following the inclusion c. patient with severe renal impairment d. patient who has presented, during the 3 months before inclusion, an acute ischemic event (acute myocardial infarction or stroke) e. patient with an active neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant f. patient treated for a chronic disease requiring high doses of systemic corticosteroids on a daily basis (≥ 40 mg prednisolone) g. patient with infection which is not controlled by a suitable antibiotic treatment h. patient with any known allergy or reported adverse reaction to the trial device
long term effectiveness of dacryocystorinostomy with and without bicanalicular intubation

Conditions: Lacrimal Duct Obstruction

Summary: dacryocystorinostomy (dcr) is an operation that is indicated for lacrimal duct obstruction. as a result of the lacrimal duct obstruction, tears are retained over the obstacle and repeated lacrimal infections occur. during dcr, the lacrimal sac is opened above the obliterated lacrimal duct and subsequently drained into the nasal cavity. the most common cause of unsuccessful surgery is intranasal stoma scarring. one of the methods that can increase the success rate of surgery is the introduction of silicone stent into the lacrimal duct during dcr, so-called bicanalicular intubation of the lacrimal system. the aim of the study is to compare long term effectiveness of dcr with and without bicanalicular intubation.

dacryocystorinostomy (dcr) is an operation that is indicated for lacrimal duct obstruction. lacrimal duct obstruction can be caused by inflamation and trauma or might be the consequence of previous surgery in the lacrimal duct region. as a result of the lacrimal duct obstruction, tears are retained over the obstacle and repeated lacrimal infections occur. during dcr, the lacrimal sac is opened above the obliterated lacrimal duct and subsequently drained into the nasal cavity. the results of dcr are generally excellent and the success rate (regression of complaints) varies between 85-95% depending on the condition of the lacrimal pathways before surgery. yet there is a constant effort to improve the results of operations. the most common cause of unsuccessful surgery is intranasal stoma scarring. it is caused by an inadequately formed bone window, an individual tendency to healing and scar formation, but a frequent cause is the insufficient opening of the tear bag or the formation of scars between the nasal septum and the lateral nasal wall. one of the methods that can increase the success rate of surgery is the introduction of silicone stent into the lacrimal duct during dcr, so-called bicanalicular intubation of the lacrimal system. silicone stent remains in the lacrimal system for 12 weeks and prevents scarring. results of previous studies are not clear whether bicanalicular intubation is beneficial. the aim of the study is to compare long term effectiveness of dcr with and without bicanalicular intubation.

Eligibility criteria:
inclusion criteria: * patients with lacrimal duct obstruction * 18 to 79 years of age * capable of general anesthesia * signing of the informed consent exclusion criteria: - inability to undergo general anesthesia

Keywords: lacrimal duct obstruction bicanalicular intubation dacryocystorinostomy silicone stent
laparoscopic gastric bypass as metabolic surgery in obesity class 1

Conditions: Type2 Diabetes; Bariatric Surgery Candidate; Laparoscopic Gastric Bypass; Obesity

Summary: prospective study including mexican patients diagnosed with type 2 diabetes and class 1 obesity, undergoing laparoscopic gastric bypass. the objective was to determine short, mid-and long-term outcomes (weight loss, metabolic, morbidity and diabetes remission). a subanalysis was included, based on preoperative usage of one (group a) or more antidiabetics ± insulin (group b).


Eligibility criteria:
inclusion criteria any sex \>18 years-old \<60 years-old class 1 obesity (bmi 30-34.9 kg/m2) type-2 diabetes mellitus diagnosis (with or without medication) submitted to laparoscopic gastric bypass exclusion criteria other bariatric surgery revisional surgery incomplete charts

Keywords: bariatric surgery obesity class 1 metabolic surgery laparoscopic gastric bypass type-2 diabetes mellitus
lux-breast 3; afatinib alone or in combination with vinorelbine in patients with human epidermal growth factor receptor 2 (her2) positive breast cancer suffering from brain metastases

Conditions: Breast Neoplasms; Neoplasm Metastasis

Summary: the aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with her2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy


Eligibility criteria:
inclusion criteria: 1. patients with her2 positive breast cancer with a documented central nervous system (cns) recurrence/progression (by imaging) during or after a her2 inhibitor (trastuzumab and/or lapatinib) based therapy (no leptomeningeal carcinomatosis as the only site of cns metastases) 2. at least one measurable and progressive lesion in the brain (=10 mm on t1-weighted, gadolinium-enhanced magnetic resonance imaging). measurable or non measurable extracranial metastases allowed. 3. previous treatment with her2 inhibitors to be discontinued prior to first study treatment administration (at least 14 days for trastuzumab and other antibodies, at least 7 days for lapatinib). 4. previous chemotherapy and hormonal therapy (adjuvant and metastatic regimens) allowed, but chemotherapy must have been discontinued at least 14 days and hormonal therapy at least 7 days prior to first study treatment administration. 5. patients must have recovered to baseline condition or to common terminology criteria for adverse events (ctcae) version 3.0 grade = 1 from any acute ctcae v. 3.0 grade =2 side effects of previous treatments. 6. prior surgery, whole brain radiotherapy or stereotactic radiosurgery allowed provided that there is unequivocal evidence of one or more new and/or progressive brain metastases after completion of whole brain radiotherapy or stereotactic radiosurgery. exclusion criteria: 1. prior treatment with her2- tyrosine kinase inhibitor other than lapatinib 2. any other current malignancy or malignancy diagnosed within the past five (5) years (other than bilateral primary breast cancer, metastases to the contralateral breast, non-melanomatous skin cancer and in situ cervical cancer). 3. significant chronic or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. crohn's disease, malabsorption or common terminology criteria (ctc) grade =2 diarrhoea of any aetiology.
pemetrexed as salvage treatment in squamous cell carcinoma of head and neck

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: the aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and neck.

the treatment option in patients with platinum-resistant relapsed or metastatic squamous cell carcinoma of head and neck is limited. previous randomized phase iii study showed a borderline benefit of pemetrexed added to cisplatin. therefore, we aim to evaluate the efficacy of pemetrexed in salvage setting.

Eligibility criteria:
inclusion criteria: * age range: 18-65 years old * histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck * prior exposure of at least one line of platinum-containing regimen * at least one site of measurable disease according to recist criteria * ecog performance status 0-1 * life expectancy of more than 3 months * bone marrow function: anc≧1.5×109/l, plt≧100×109/l, hb≧80g/l * liver function: total bilirubin, alt and ast \<1.5×unl * renal function: cr\<1.5×unl, ccr≧45ml/min exclusion criteria: * with curable treatment option * prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * significant active infection * pregnant or lactating women

Keywords: squamous cell carcinoma of head and neck pemetrexed
intraoperative intravenous lidocaine

Conditions: Pain Intensity

Summary: the objective of the present study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain after hysterectomy.

study design a prospective, randomized, double-blind study was conducted according to ethical guidelines for research involving humans. the study was approved by the ethics committee of the institution and all patients signed a free informed consent form. the patients were randomly allocated to two groups consisting of the same number of subjects by drawing lots. one physician prepared the solutions and handed them over to the anesthetist who was unaware of the content of the solutions. the volume of the solutions was the same. the researcher was unaware to which group the patient belonged until the end of the study. exclusion criteria excluded from the study were patients with cardiac arrhythmia; myocardiopathy; altered cardiac conduction; psychiatric, hepatic or respiratory disease; and patients receiving any type of analgesic during the week before surgery. patients forty women (asa 1 or 2) aged 18 to 60 years undergoing hysterectomy were studied. treatment patients of group 1 (n = 20) received lidocaine (2 mg/kg/h) and patients of group 2 (n = 20) received 0.9% saline infusion throughout the surgical procedure. anesthesia oral midazolam (15 mg) was administered one hour before anesthesia as pre-anesthetic medication. anesthesia was induced with 5 µg/kg fentanyl and 2 mg/kg propofol. neuromuscular block was maintained with atracurium. anesthesia was maintained with o2/isoflurane. patient assessment the supplemental morphine doses necessary during the first 24 h and the time to first analgesic request were recorded. pain intensity was evaluated at rest on a numerical scale ranging from 0 to 10 (0 = no pain and 10 = most intense pain possible) at the following times: t0 (immediately after arousal), and 6, 12, 18 and 24 h after arousal. side effects were recorded. statistical analysis the results were analyzed statistically with the instat graph program using parametric and nonparametric tests, depending on the nature of the variables studied. measures of central tendency (means) and dispersion (standard deviation) were used. the level of significance was set at \< 0.05. the following tests were used: mann-whitney test for age, body mass index, duration of anesthesia and surgery, time to first analgesic supplementation, total amount of morphine, pain intensity, and isoflurane consumed; student t-test for weight and height; and friedman test for pain intensity.

Eligibility criteria:
inclusion criteria: * asa 1 or 2, aged 18 to 60 years undergoing hysterectomy exclusion criteria: * cardiac arrhythmia; myocardiopathy * altered cardiac conduction * psychiatric, hepatic or respiratory disease * patients receiving any type of analgesic during the week before surgery

Keywords: intravenous lidocaine postoperative analgesia
observational study on the clinical profile of patients with uncontrolled severe asthma treated with tezepelumab in italy

Conditions: Asthma

Summary: this observational study aims to collect data in clinical practice on the clinical profile of patients treated with tezepelumab from q1 2024 to q1 2025 according to the approved and reimbursed indication in italy

there is a current need to gain information on the clinical profile of patients eligible for treatment with tezepelumab according to the approved and reimbursed indication in italy. moreover, being tezepelumab the latest approved biologic drug for severe asthma, it is important to better understand clinical response to treatment in patients with high severe asthma burden as: patients with allergic-eosinophilic phenotype; patients with low eosinophils level; patients affected by severe asthma associated with sinonasal disease; biologic-naïve patients, as well as bio-treated patients. the present observational study aims at filling the above-mentioned knowledge gaps in the study population in terms of clinical course, disease control and clinical remission, use of healthcare resources (treatments, visits, hospitalizations), lung functions, biomarkers, and sinonasal outcomes.

Eligibility criteria:
inclusion criteria: 1. adult and adolescent patients (age ≥12 years) at the index date (i.e., first administration of tezepelumab); 2. patients with severe uncontrolled asthma (diagnosed according to clinician's judgment as per ers-ats or gina guidelines) requiring a stable treatment of high doses of ics and a long acting β2 agonist ± additional asthma controller; 3. patients who received at least one injection of tezepelumab from february 2024 to march 2025 , according to italian reimbursement indications; 4. patients who signed the icf and privacy form. 5. patients with continuous enrolment in the data source for at least 12-months before the index date. 6. patients with at least three months of continuous enrolment in the data source after the index date. exclusion criteria: 1. patients with hypersensitivity to the active ingredient or any of the excipients of tezspire; 2. patients who received any biologic drug for the treatment of asthma in a clinical trial at any time during the 12-months prior to the index date. 3. patients who, during the observation period, participated in studies imposing a specific patient's management strategy, which does not correspond to the site's normal clinical practice.

Keywords: asthma, uncontrolled severe asthma
reward: using the retina as a window to detect cardiac microvascular dysfunction in diabetes mellitus

Conditions: Retinopathy, Diabetic; Diastolic Dysfunction; Microalbuminuria

Summary: retinopathy may be associated with diastolic dysfunction and/or coronary flow reserve in the heart, and albuminuria in diabetic patients. the objective of this study is to examine the cross-sectional relationships of retinopathy with indices of left ventricular diastolic function, coronary flow reserve and urinary albumin excretion, among diabetic patients.

diabetes is a potent risk factor for macrovascular coronary disease, leading to systolic dysfunction and heart failure. more recently diabetic microvascular disease has been recognized to play a key role in the development of diastolic dysfunction and heart failure with preserved ejection fraction. a new paradigm in diabetic heart disease centers on microvascular endothelial dysfunction involving the intra-myocardial capillaries and leading to cardiomyocyte dysfunction and diastolic dysfunction. this is analogous to the microvascular dysfunction well-described in the diabetic retinopathy and nephropathy. yet, whereas diabetic retinal screening for retinopathy and screening for microalbuminuria are routine, diabetic cardiac screening for microvascular dysfunction is practically non-existent. the retinal vasculature may represent a window of opportunity to detect concurrent microvascular disease in the heart and kidneys before the onset of clinical symptoms. however, there are limited studies that directly attempt to correlate retinopathy to diastolic dysfunction and microalbuminuria. hence this study aims to examine the cross-sectional relationships of retinopathy with indices of left ventricular diastolic function, coronary flow reserve and urinary albumin excretion, among diabetic patients.

Eligibility criteria:
inclusion criteria: * age greater than equal to 21 years old exclusion criteria: * known history of active eye lens or corneal opacity * known allergy to eye drops * kidney disease with estimated gfr \< 60 * pregnant or lactating women * asthmatic status of the moderate persistent and above categories * chronic obstructive pulmonary disease * thyroid dysfunction