Kornimate/medical-research-clean huggingface dataset:
satisfaction with freestyle libre 2 monitoring versus capillary blood glucose monitoring in people with dm2

Conditions: Diabetes Mellitus, Type 2

Summary: the freestyle libre 2 system is a flash glucose monitoring system that, after a scan, provides information on interstitial glucose for the last 8 hours in the form of a reading every 15 min. the system is approved for non-adjuvant use for therapeutic decision-making. the acceptability and effectiveness of the fsl is well documented in patients with type 1 and 2 diabetes mellitus (dm2). most of the studies in patients with dm2 have been developed in patients with insulin treatment, either basal or with multiple doses. for all these reasons, we proposed an exploratory study to evaluate satisfaction with treatment (main variable) in people with dm2 who start glucose monitoring in the endocrinology day hospital context compared to patients who use capillary blood glucose monitoring. these are patients treated in a context of debut/acute decompensation/intercurrent pathology, who will not necessarily be using insulin treatment. the aim is to know if the use of fsl2 provides benefits of user satisfaction with the treatment, assessed with the diabetes treatment satisfaction questionnaire at the end of follow-up (mean score of all items); in this context.

when the doctor determines that the patient who has attended the endocrinology and nutrition day hospital needs to start glucose monitoring and goes to the nursing office, if he meets the inclusion criteria, he will be asked to participate in the study. after signing the informed consent, the control group (mgc) or intervention group (fsl2) will be randomised. the necessary therapeutic education for glucose monitoring will be carried out in parallel with the other necessary aspects of diabetes therapeutic education. follow-up visits in both groups will take place 24-48 hours after the first visit, a week, 2 weeks, and 1, 2, and 3 months after the first visit. during visits, frequently according to usual clinical practice, by the nurse and/or doctor, therapeutic decisions will be made based on the monitoring system assigned to the patient.

Eligibility criteria:
inclusion criteria: * diagnosed with dm2. . who have reached 18 years of age. * who are candidates to start glucose monitoring according to the usual clinical practice of the endocrine day hospital of the hospital de sant pau. * that they are not using any glucose monitoring tool. these may be patients with debut diabetes, worsening control with high hba1c levels, or starting treatment with glucocorticoids. patients may have any of these conditions, or similar ones, as long as they meet the other inclusion criteria and none of the exclusion criteria. similarly, no specifications are made for drug treatment prior to or initiated at the recruitment visit. exclusion criteria: * pregnant or expecting to be during the duration of the study. * assessed by the healthcare professional responsible for proposing the study to them as more harmful than beneficial their inclusion in it.

Keywords: diabetes glucose monitoring satisfaction diabetes technology
a safety study using pentamidine in patients with pancreatic cancer undergoing standard therapy

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to investigate the safety and possible efficacy of the use of pentamidine in the treatment of pancreatic cancer metastasis in subjects receiving standard therapy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven diagnosis of advanced pancreatic adenocarcinoma that is unresectable or metastatic. at least one uni-dimensionally measurable lesion (on spiral ct scan) * 18 years of age or older * ecog performance status 0, 1 or 2 * serum aspartate transaminase (ast) serum alanine transaminase (alt) £ 2.5 x upper limit of normal (uln), or ast and alt £ 5 x uln if liver function abnormalities are due to underlying malignancy * total serum bilirubin £ 2 x uln * lipase within normal limits (1.5x uln) * absolute neutrophil count (anc) ≥ 1500/ul (1.5 x 109/l) * platelets ≥ 100,000/ul * hemoglobin ≥ 9.0 g/dl * serum creatinine £ 1.5 x uln or calculated creatinine clearance ≥ 50 ml/min * ca19-9 level ≥ 37 u/ml * normal ecg * signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment * willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures * life expectancy, in the opinion of the investigator, \> 3 months exclusion criteria: * bp \< 100 (systolic) * history of uncontrolled renal disease, pancreatitis, or diabetes mellitus * peripheral sensory neuropathy (\> grade 1, as per nci ctcae version 3.0) * concomitant therapy with other investigational agents or participation in another clinical trial within the previous 3 months. * any of the following conditions: ongoing cardiac dysrhythmias of nci ctcae grade ≥ 2; atrial fibrillation of any grade; qtc interval \>450 msec for males or \>470 msec for females or uncontrolled intercurrent illness, e.g., unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia \<50 bpm * active uncontrolled bacterial infection * concurrent use of drugs that could prolong qt interval * concurrent use of nephrotoxic drugs, including aminoglycosides, ampho b, foscarnet, cidofovir * concurrent use of drugs that may be associated with pancreatitis * concurrent active cancer originating from a primary site other than pancreas or history of cancer \< 3 years except for skin superficial bladder, uterus etc * history of allergy or hypersensitivity to pentamidine * pregnancy or breastfeeding. all female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to first dose of study medication. * severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgement of the investigator, excess risk associated with trial participation of study drug administration, or which in the judgement of the investigator, would make the subject inappropriate for entry into this trial. * on oral anticoagulants (lmwh is acceptable)
ramelteon in the prevention of post-operative delirium

Conditions: Delirium; Delirium, Dementia, Amnestic, Cognitive Disorders; Delayed Emergence From Anesthesia; Cognitive Disorders

Summary: this trial focuses on a phase ii randomized masked clinical trial testing the effectiveness and safety of peri-operative administration of ramelteon, a melatonin agonist in the prevention of postoperative delirium.

this trial will randomize older aged patients undergoing general or regional anesthesia for orthopedic surgical procedures to three perioperative doses of a melatonin agonist, ramelteon, and placebo in a masked double blind fashion. the primary outcomes are 1) the incidence of post-operative delirium in the recovery period in the postoperative anesthesia care unit and on post-operative days 1 and 2 following surgery, and 2) the safety of ramelteon as documented by the presence of adverse events in the follow-up period.

Eligibility criteria:
* planned orthopedic surgery under general or regional anesthesia and post-operative inpatient stay * 65 years of age or older * mini-mental status exam (mmse) score of 15 or greater prior to surgery; * ability to understand, speak, read and write english. exclusion criteria: * delirium diagnosis on the confusion assessment method instrument at baseline * is unable to give informed consent due to cognitive impairment and a suitable legally authorized representative (lar) cannot be identified * declines participation * current medications that include: 1. ramelteon 2. melatonin 3. fluvoxamine 4. rifampin 5. ketoconazole 6. fluconazole * history of ramelteon or riboflavin intolerance * heavy daily alcohol intake by medical record or history * current moderate to severe liver failure (as defined by charlson criteria * evidence of systemic inflammatory response syndrome (sirs) as measured by \> 2 criteria8) * presence of a condition that in the opinion of the pi compromises patient safety or data quality if enrolled in the study.

Keywords: post-operative delirium
safety of inhaled human insulin in subjects with diabetes mellitus and chronic obstructive pulmonary disease (copd)

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Chronic Obstructive Pulmonary Disease

Summary: this trial is conducted in europe, asia and south america. a one-year clinical trial to compare the safety of inhaled human insulin to subcutaneous insulin aspart in subjects with type 1 or type 2 diabetes and chronic obstructive pulmonary disease (copd).

the decision to discontinue the development of aerx® is not due to any safety concerns. an analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease * type 1 or type 2 diabetes * hba1c lower or equal to 11.0 % * body mass index (bmi) lower or equal to 40.0 kg/m2 exclusion criteria: * recurrent severe hypoglycaemia * current smoking or smoking within the last 6 months * other pulmonary disease including asthma * proliferative retinopathy or maculopathy requiring acute treatment
a study of ramucirumab (ly3009806) or merestinib (ly2801653) in advanced or metastatic biliary tract cancer

Conditions: Biliary Tract Cancer; Metastatic Cancer; Advanced Cancer

Summary: the main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.


Eligibility criteria:
inclusion criteria: * have an eastern cooperative oncology group performance status of 0 or 1. * have a histologically or cytologically confirmed diagnosis of non-resectable, recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampulla of vater) . * have measurable disease by response evaluation criteria in solid tumors (recist). * have adequate biliary drainage. * have adequate organ function. * males and females are sterile, postmenopausal, or compliant with a highly effective contraceptive method. * female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose. * are willing to provide blood/serum/plasma and tumor tissue samples for research purposes. submission of blood/serum/plasma and tumor tissue samples is mandatory for participation in this study, unless restricted per local regulations. exclusion criteria: * previous systemic therapy for locally advanced or metastatic disease is not allowed. * have a history of or have current hepatic encephalopathy of any grade, or ascites of grade \>1, or cirrhosis with child-pugh stage b or higher. * have ongoing or recent (≤6 months) hepatorenal syndrome. * have had a major surgical procedure or significant traumatic injury including nonhealing wound, peptic ulcer, or bone fracture ≤28 days prior to randomization. * anticipate having a major surgical procedure during the course of the study. * has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression. * within 6 months prior to randomization, have had any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. * have an uncontrolled arterial hypertension with systolic blood pressure ≥150 or diastolic blood pressure ≥90 millimeters of mercury (mm hg) despite standard medical management. * have a previous malignancy within 5 years of study entry or a concurrent malignancy. * have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization. * have a known allergy or hypersensitivity reaction to any of the treatment components. * have a history of uncontrolled hereditary or acquired thrombotic disorder. * have uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk and/or make assessment of survival uncertain. * have mixed hepatocellular biliary tract cancer histology. * have a corrected qt interval \>470 milliseconds as calculated by the fridericia equation.
advanced diffusion imaging in renal cancer patients

Conditions: Renal Cancer

Summary: the objective of this study is to apply advanced diffusion imaging in a two-pronged assessment of renal mass patients: (1) characterization of lesion malignancy and subtype, and (2) prediction of renal function stability or decline following partial nephrectomy.


Eligibility criteria:
inclusion criteria: * renal mass patients scheduled for laparoscopic partial nephrectomy. * egfr above 30 ml/min/m2. * ages 21 to 85 * must be willing and able to provide consent. exclusion criteria: * all metal implants and dental implants that have ferromagnetic properties and are unsafe at 3.0 t. * pregnant women are not eligible for participating in this study. * acute claustrophobia
a study of safety of weekly subcutaneous pegzilarginase in subjects with arginase 1 deficiency

Conditions: Arginase I Deficiency; Hyperargininemia

Summary: this is an open-label, multicenter study to evaluate the safety of weekly sc administration of pegzilarginase over 12 months in subjects with arg1-d. the study consists of a screening period of up to 4 weeks, a subsequent 12-month treatment period, and a safety follow-up visit 2 weeks after the last treatment.

open-label, multicenter study to evaluate the safety of weekly sc administration of pegzilarginase over 12 months in subjects with arg1-d. the study consists of a screening period of up to 4 weeks, a subsequent 12-month treatment period, and a safety follow-up visit 2 weeks after the last treatment.

Eligibility criteria:
inclusion criteria: 1. prior enrollment in pegzilarginase clinical studies, with completion of treatment or continued dosing as of the study termination date 2. written informed consent by subject/parent/legal guardian, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol 3. negative pregnancy test within 7 days prior to dosing in childbearing subjects if they are sexually active 4. if the subject (male or female) is engaging in sexual activity that could lead to pregnancy, must be surgically sterile, post-menopausal (female), or must agree to use a highly effective method of birth control during the study and for a minimum of 30 days after the last study drug administration. highly effective methods of contraception include combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation, progesterone-only hormonal contraception associated with inhibition of ovulation, intrauterine device, or intrauterine hormone-releasing system exclusion criteria: 1. subjects with acute or ongoing hyperammonemia within 6 weeks of the first dose 2. subjects with medical conditions or underlying issues that, in the opinion of the investigator, would preclude participation in the study

Keywords: arg1-d
mother-to-child transmission of hbv in china

Conditions: Hepatitis B, Chronic; Mother to Child Transmission

Summary: in order to evaluate the feasibility of eliminating mother-to-child transmission (mtct) of hepatitis b virus (hbv) by 2030, a multi-center, prospective cohorts study was conducted to investigate mtct of hbv in china.

a prospective, multicenter study of pregnant women with hbv infection was conducted from july 2015 up to now in a real world setting in the shield project stage ⅱ. inclusion criteria was any pregnant women with chronic hbv infection. pregnant women were excluded if they had a positive serologic test for human immunodeficiency virus or hepatitis c virus or any co-morbidity that might reduce compliance or if they were unable or unwilling to use the mobile health application-shield app. enrolled mothers and infants were prospectively followed until infant post-vaccination serologic testing (pvst) was performed at 7-12 months of age. demographic data, antiviral treatment history, pregnancy and labour history, co-morbidity, hbv serologic marker tests, hbv dna tests, liver function tests, mode of delivery, neonatal characteristics (height, weight, head circumference, apgar score and any major birth defect), breastfeeding and pvst for infants at 7-12 months of age were collected. a mobile health application called "shield" was developed and used in the shield project stage ⅱ to collect data and provide support for communication between mothers and their doctors. all laboratory test reports, questionnaires and other relevant information was uploaded into shield. participants could consult with their doctors via shield during the follow-up.

Eligibility criteria:
inclusion criteria: * pregnant women with chronic hbv infection. exclusion criteria: * positive serologic test for human immunodeficiency virus or hepatitis c virus; * any co-morbidity that might reduce compliance; * unable or unwilling to use the mobile health application-shield app

Keywords: hepatitis b mother-to-child transmission
mothers' breast milk expression experiences, infant feeding attitudes and perceived social support levels

Conditions: Breastfeeding; Breast Milk Expression; Feeding Behavior; Support, Family

Summary: background: expressing breast milk in cases where breastfeeding is interrupted is important for infants to be fed breast milk however, many factors can affect mothers' breastfeeding experience, such as feeding attitudes and the level of social support. the aim of this study is to determine the relationship mothers' breast milk expression experience between infant feeding attitudes and perceived social support level. methods: this cross-sectional study was carried out in the postpartum and lactation unit of a city hospital in istanbul, between september-november 2022. the study included 455 women who were volunteering to participate in the research, 18 years of age or older, in the 0-6 months postpartum period, having a living baby, continuing to breastfeed, and expressing breast milk at least once after birth. data were collected with mother-baby introductory information form, breast milk expression experience measure (bmee), iowa infant feeding attitude scale (iifas), and multidimensional scale of perceived social support (mspss). the data were analyzed using the spss-21 statistical software package. the main questions it aims to answer are: * which characteristics affect mothers' breast milk expression experiences, infant feeding attitudes, and perceived social support levels in the early postpartum period? * is there a relationship between mothers' experiences of breast milk expression and their infant feeding attitudes and social support levels in the early postpartum period?


Eligibility criteria:
inclusion criteria: * volunteer to participate in the research * 18 years of age or older * in the 0-6 month postpartum period * must have a living baby * must continue breastfeeding * must express breast milk at least once after birth exclusion criteria: * feeding the infant formula only * having hearing and/or speech impairments
mirena in idiopathic menorrhagia

Conditions: Idiopathic Menorrhagia

Summary: this is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.the patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after insertion.


Eligibility criteria:
inclusion criteria: * woman diagnosed with idiopathic menorrhagia according to assessment of the investigator and according to international guidelines. these woman should also accept to be on contraception during the time period that they have mirena in situ. * age limit 30-45 * bmi= 18-34 * signed informed consent exclusion criteria: * medical conditions featured in the mirena data sheet (see appendix 1) that contraindicate its use, listed below: * known or suspected pregnancy; current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product. * nulliparity * consumption of iron, antiprostaglandins, hormonal drugs and any medication that could effect bleeding should be stopped at least 3 months before the first visit and should not be used during the course of the study. * history of diabetes mellitus,cardiovascular disease and thyroid abnormalities * anticoagulation therapy * cancer history including breast cancer.
a clinical study of tqb3107 tablets in patients with malignant tumors

Conditions: Advanced Cancers

Summary: tqb3107 is a protein inhibitor that induces apoptosis and inhibits the proliferation of various tumor cells. this clinical study aims to evaluate the safety and tolerability of tqb3107 tablets in subjects with advanced malignancies, to determine the dose-limiting toxicities (dlts), maximum tolerated dose (mtd) (if any), and the recommended dose for phase ii (rp2d).


Eligibility criteria:
inclusion criteria: * 18 years ≤ age≤ 75 years (calculated from the date of signing the informed consent); score 0\~1 point, estimated survival ≥ 3 months； * malignant tumors with no standard treatment regimen or disease progression or intolerance after prior standard therapy； * the major organs are functioning well； * negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception throughout the study and for 6 months after the study ends; * subjects voluntarily participated in this study, signing the informed consent form and demonstrating good compliance. exclusion criteria: * hematologic malignancy has or is suspected to involve the central nervous system, or primary central nervous system lymphoma; * received any anti-cancer therapy such as major surgery, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to the first dose; * combined with severe or not well-controlled diseases, which the investigator judges to be at greater risk of entering this study； * those with a history of drug addiction or substance abuse； * based on the investigator's judgement, subjects with concomitant diseases that pose a significant risk to their safety or compromise the study's completion, or subjects deemed unsuitable for enrollment due to other reasons, will be excluded.
a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ro7234292 (isis 443139) in huntington's disease patients who participated in prior investigational studies of ro7234292 (isis 443139)

Conditions: Huntington's Disease

Summary: this study will test the safety, tolerability, pharmacokinetics and pharmacodynamics of ro7234292 administered intrathecally to adult patients with huntington's disease.


Eligibility criteria:
key inclusion criteria: * must have completed dosing in isis 443139-cs1 key exclusion criteria: * any new condition or worsening of existing condition that could make the patient unsuitable for participation or interfere with the patient participating in and/or completing the study