Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (t2dm).


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * subjects diagnosed with t2dm and on unchanged metformin treatment at the maximum tolerated dose (at least 1000 mg/day and up to 3000 mg/day) for at least 90 days prior to screening * hba1c 7.5 - 10.5% (53 mmol/mol - 91 mmol/mol) (both inclusive) * body mass index (bmi) equal to or above 20 kg/m\^2 exclusion criteria: * female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. (adequate contraceptive measures as required by local law or practice) * treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with intercurrent illness * history of chronic pancreatitis or idiopathic acute pancreatitis * screening calcitonin value equal to or above 50 ng/l * personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2) * impaired liver function, defined as alanine aminotransferase (alat) equal to or above 2.5 times upper normal limit (unl) * impaired renal function defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m\^2 per modification of diet in renal disease (mdrd) formula * any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (tia) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening * heart failure, new york heart association (nyha) class iv * uncontrolled hypertension (defined as systolic blood pressure equal to or above 180 mmhg and/or diastolic blood pressure equal to or above 100 mmhg) * diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
study of alxn2220 versus placebo in adults with attr-cm

Conditions: Transthyretin Amyloid Cardiomyopathy

Summary: the primary objective of this study is to access the efficacy of alxn2220 in the treatment of adult participants with attr-cm by evaluating the difference between the alxn2220 and placebo groups as assessed by the total occurrences of all-cause mortality (acm) and cardiovascular (cv) clinical events.


Eligibility criteria:
inclusion criteria: * diagnosis of attr-cm with either wild-type or variant ttr genotype * end-diastolic interventricular septal wall thickness ≥ 12 mm on echocardiography measured at screening * nt-probnp \> 2000 pg/ml at screening * treatment with a loop diuretic for at least 30 days prior to screening * history of heart failure nyha class ii-iv at screening * life expectancy of ≥ 6 months as per the investigator's judgment * males and females of childbearing ability must use contraception exclusion criteria: * known leptomeningeal amyloidosis * known light chain (al) or secondary amyloidosis (aa), or any other form of systemic amyloidosis * acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of screening * uncontrolled clinically significant cardiac arrhythmia, per investigator's assessment * lvef \< 30% on echocardiography * renal failure requiring dialysis or an egfr \< 20 ml/min/1.73 m2 at screening * polyneuropathy with pnd score iv

Keywords: amyloid depleter alxn2220 all-cause mortality (acm) cardiovascular (cv) transthyretin amyloid cardiomyopathy transthyretin amyloid (attr) transthyretin (ttr) n-terminal pro b-type natriuretic peptide (nt-probnp) nt-probnp amyloidosis attr-cm
to evaluate the efficacy of al-38583 in the reduction of tear eosinophil count following conjunctival allergen challenge

Conditions: Allergic Conjunctivitis

Summary: the purpose of the study is to determine whether al38583 ophthalmic solution is safe and effective in reducing tear eosinophil levels at 5-8 hours after conjunctival allergen challenge (cac).


Eligibility criteria:
inclusion criteria: * have a positive bilateral cac reaction (\>2 itching and \> conjunctival redness) to cat hair, cat dander, dust mites, cockroaches and/or dog dander within 10 minutes of instillation of the last titration of allergen at visit 1 exclusion criteria: * have a known allergy to the study medication(s) or their components (ex., dexamethasone, benzalkonium chloride)

Keywords: conjunctivitis
deep radiomics-based fusion model predicting bevacizumab treatment response and outcome in patients with colorectal liver metastases

Conditions: The Patients With CRLM Who Benefit More From Bevacizumab

Summary: this multi-modal deep radiomics model, using pet/ct, clinical and histopathological data, was able to identify patients with bevacizumab-sensitive unresectable colorectal cancer liver metastases, providing a favorable approach for precise patient treatment.

accurately predicting tumor response to targeted therapies is essential for guiding personalized conversion therapy in patients with unresectable colorectal cancer liver metastases (crlm). currently, tumor response evaluation criteria are based on assessments made after at least 2-months treatment. consequently, there is a compelling need to develop baseline tools that can be used to guide therapy selection. herein, the investigators proposed a deep radiomics-based fusion model which demonstrates high accuracy in predicting the efficacy of bevacizumab in crlm patients. further, the investigators observed a significant and positive association between the predicted-responders and longer progression-free survival as well as longer overall survival in crlm patients treated with bevacizumab. moreover, the model exhibits high negative prediction value, indicating its potential to accurately identify individuals who are unresponsive to bevacizumab. thus, our model provides a valuable baseline method for specifically identifying bevacizumab-sensitive crlm patients, which is offering a clinically convenient approach to guide precise patient treatment.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years and ≤75 years; 2. patients were histologically confirmed for colorectal adenocarcinoma with unresectable liver-limited or liver-dominant metastases 3. pet/ct at baseline were available 4. first line treated with folfox+ bevacizumab. exclusion criteria: 1. resectable liver metastases; 2. wide-type kras/nras; 3. no measurable liver metastasis; 4. no efficacy assessment; 5. no follow-up information.
aortic dimensions in patients with fabry disease

Conditions: Fabry Disease

Summary: we will conduct a retrospective study aiming to define the characteristics, determinants, and progression of ascending aortic dilatation in adults with fabry disease, using echocardiography and/or cardiac mri


Eligibility criteria:
inclusion criteria: a adult patients with genetically confirmed fabry disease must be able to signed informed consent for participation in the study exclusion criteria: patient refusal to participate in the study
combination therapy of imiquimod 5%cream and cryotherapy vs monotherapy for common warts:randomized comparative trial.

Conditions: Warts

Summary: to assess the clinical efficacy and safety of topical imiquimod 5% cream combined with cryotherapy versus either of theme alone for the treatment of common warts by clinical and dermoscopic assessments.

topical imiquimod 5% cream combined with cryotherapy versus either of them alone in treatment of common warts: a prospective randomized comparative trial

Eligibility criteria:
inclusion criteria: * patients with common warts diagnosed clinically and by dermoscopy. * patients older than 18years old. exclusion criteria: * pregnancy and lactation. * immunosuppression or being under any kind of treatment causing * absolute or relative immunosuppression. * patients with chronic systemic diseases. * all cases of bleeding tendency or using anticoagulants. * concurrent use of systemic or topical treatments of warts in the last 4 weeks.
an open-label 18-month safety study of fluorouracil cream 0.5% for the treatment of actinic keratoses

Conditions: Actinic Keratoses

Summary: this study is being undertaken to: 1. assess the safety of fluorouracil cream for the treatment of actinic keratoses ("aks") on other common skin surface areas (e.g., posterior scalp, ears, neck, lips, arms and hands); 2. collect additional post-treatment safety data on fluorouracil cream applied to the face (including anterior scalp, if applicable); 3. assess the incidence of recurrence of aks on the face; and 4. assess the need for re-treatment with fluorouracil cream to the face.


Eligibility criteria:
the following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. this information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. inclusion criteria: * patients must give written informed consent; * patients must have at least 5 visible and/or palpable aks on the posterior scalp, ears, neck, lips, arms and/or hands (across all other body sites) and an additional 5 visible and/or palpable aks on the face (including anterior scalp, if applicable); * female patients must be post-menopausal for at least one year, or have had a hysterectomy, or have had a tubal ligation, or use oral/systemic contraceptives, an intrauterine device (iud) or norplant starting at least 28 days prior to study entry and throughout the study. female patients of childbearing potential must have a negative urine pregnancy test prior to the first application of test medication * patients must be compliant and willing to return to the study site for designated follow-up visits. exclusion criteria: * pregnant or lactating females; * patients with a current skin condition on the face, scalp, ears, neck, lips, arms and/or hands that could confound the study, including basal cell and squamous cell carcinomas; * patients with a known allergy to any ingredients of the test drug formulations; * patients with known dihydropyrimidine dehydrogenase (dpd) enzyme deficiency; * patients whose activities involve excessive or prolonged exposure to sunlight; * patients who use a tanning parlor; * patients treated with other topical agents for the treatment of actinic keratosis in the designated treatment area within 5 months prior to the start of the study are prohibited; * patients who have had liquid nitrogen treatment for aks within 4 weeks prior to study start in the designated treatment area; * history of drug or alcohol abuse.
brain reaction to treatment of nicotine dependence

Conditions: Nicotine Dependence

Summary: the purpose of the study was to determine how the treatments for cigarette craving work. hypothesis: during exposure to cigarette-related cues, heavy smokers will have greater reductions in regional brain activation from before to after both forms of active treatments than from before to after placebo.

pet and fmri scanning were used to examine brain activity and activation in cigarette smokers in response to cigarette-related cues.

Eligibility criteria:
inclusion criteria: * heavy smoker, more than one pack per day * free of medical conditions or medications that affect brain activity * not pregnant exclusion criteria: drug or alcohol dependence mental illness pregnancy medications that affect brain function unstable medical conditions

Keywords: position emission tomography (pet) nicotine dependence functional magnetic resonance imaging cigarette cues
prevention of end stage kidney disease by darbepoetin alfa in chronic kidney disease patients with nondiabetic kidney disease

Conditions: Chronic Kidney Disease; Diabetes

Summary: the purpose of this study is to ask whether treating non-diabetic chronic kidney disease (ckd) patients with gfr 8-20ml/min/1.73m2 by darbepoetin alfa targeting hb between 11.0 and 13.0g/dl preserves renal function better than targeting hb between 9.0 and11.0g/dl. the investigators also ask whether the higher hb targeting 11 to 13g/dl will not cause higher adverse events regarding cardiovascular diseases compared with lower hb targeting 9 to 11g/dl.

anemia is common among patients with chronic kidney disease (ckd) and is associated with an increased risk of cardiovascular and renal events. although erythropoiesis stimulating agent (esa) has been used to correct anemia, use of esa (hemoglobin level at approximately 13 g/dl) did not reduce cardiovascular or renal events in diabetic ckd patients. subgroup analysis of a recent randomized study suggested that use of darbepoetin alfa targeting hb between 11 and 13 g/dl may preserve renal function better than targeting hb between 9 and 11g/dl in non-diabetic ckd patients.

Eligibility criteria:
inclusion criteria: 1. ckd patients who have not received chronic dialysis 2. egfr 8 and more and less than 20 ml/min/1.73m2 determined twice in last 12 weeks. 3. ckd patients with renal anemia at hb less than 10g/dl within last 8 weeks 4. ckd patients with tsat 20% and higher or serum ferritin 100ng/ml and higher. 5. ckd patients treated with standard care 6. ckd patients provided written informed consent. exclusion criteria: 1. diabetes (treated, or hba1c 6.4% ifcc) 2. ckd patients treated with esa other than epoetins and darbepoetin. 3. ckd patients treated with epoetin 24000 iu/4w or more. 4. ckd patients treated with darbepoetin 90μg/4w or more. 5. uncontrolled hypertension (180/10mmhg and higher) 6. heart failure (nyha iii and iv) 7. malignancy, hematological disorder 8. malnutrition 9. active and continuous gastrointestinal tract bleeding 10. anca associated glomerulonephritis, acute infection, active sle 11. ckd patients who will undergo dialysis or receive transplantation within 6 months 12. myocardial infarction within last 6 months 13. stroke or pulmonary embolism within last 12 months 14. severe allergy 15. pregnant women, women on lactation, or ckd patients who plant to get pregnant 16. allergy against erythropoetin 17. ineligible patients according to the investigator's judgment

Keywords: renal anemia erythropoiesis stimulating agent hemoglobin non-diabetes ckd chronic kidney disease patients without diabetes
dietary milled seed mix in patients with non-hodgkin lymphoma

Conditions: Non-hodgkin Lymphoma

Summary: recent literature data suggest beneficial effects of dietary fats in patients with cancers, in particular polyunsaturated fatty acids (pufas). milled mix of flax, sesame and pumpkin seeds provides a high amount of pufas and a desirable n-6/n-3 pufas ratio.

cancers are characterized by inflammation and alternations in lipid and fatty acid metabolism. patients with non-hodgkin lymphoma have impaired fatty acid profiles, low level of pufas, and high n-6/n-3 pufas ratio. moreover, these changes are related to clinical outcome. flax seeds, sesame and pumpkin seeds are rich sources of pufas. dietary intake of milled mix of these seeds has been shown to decrease inflammation and improve pufas status in patients on hemodialysis and to decrease breast cancer risk. the study design is single-blind, controlled, randomized nutritional intervention. the participants are randomly assigned into intervention and control group before starting chemotherapy. all patients receive nutritional counseling to achieve a daily energy and protein intake according to recommended dietary allowances, with (intervention) or without (control) of milled seed mix.

Eligibility criteria:
inclusion criteria: * histologically confirmed non-hodgkin lymphoma * patients able to understand requirements of the study and provide written informed consent exclusion criteria: * previous radio- or chemotherapy * other serious chronic diseases * statin therapy * presence of allergy on any seeds * use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3 months prior to study
vascular endothelial growth factor (vegf) trap-eye: investigation of efficacy and safety in central retinal vein occlusion (crvo)

Conditions: Retinal Vein Occlusion

Summary: to determine the efficacy of vascular endothelial growth factor (vegf) trap-eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion


Eligibility criteria:
inclusion criteria: * center-involved macular edema secondary to central retinal vein occlusion (crvo) for no longer than 9 months with mean central subfield thickness ≥ 250 μm on optical coherence tomography (oct) * adults ≥ 18 years * early treatment diabetic retinopathy study (etdrs) best corrected visual acuity (bcva) of 20/40 to 20/320 (73 to 24 letters) in the study eye exclusion criteria: * any prior treatment with anti-vegf agents in the study eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of systemic anti-angiogenic medications * prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye * crvo disease duration \> 9 months from date of diagnosis * previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to day 1 * iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye

Keywords: macular edema central retinal vein occlusion crvo vegf trap-eye best-corrected visual acuity
social-emotional and behavioural problems of healthcare workers during the outbreak

Conditions: Emotional Disorder of Childhood

Summary: healthcare worker mothers had to leave their children with their relatives out the fear of contagion and isolated themselves. the investigators aimed to explore the sleep, socioemotional and behavioural problems of children of healthcare workers; assess the psychological distress of mothers and their social support during the severe acute respiratory syndrome corona virus pandemic, and compare them with age-matched children and their mothers from other occupations.

healthcare worker mothers had to leave their children with their relatives out the fear of contagion and isolated themselves. the investigators aimed to explore the sleep, socioemotional and behavioural problems of children of healthcare workers; assess the psychological distress of mothers and their social support during the severe acute respiratory syndrome corona virus pandemic, and compare them with age-matched children and their mothers from other occupations. a case-control study design was applied, and a snowball approach was used to enrol volunteered participants aged between 6 to 36 months of age, through a google survey. the investigators used brief infant sleep questionnaire and the brief infant-toddler social and emotional assessment questionnaire to assess children's sleep and socioemotional and behavioural problems respectively. a multidimensional scale of perceived social support and a brief symptom inventory were used to evaluate the social support and psychological distress of mothers.

Eligibility criteria:
inclusion criteria: * all women having children aged between 6 to 36 months of age, * parental education above university level, exclusion criteria: * out of age range, * parental education below university level * didn't read the informed consent form and tick the mandatory consent box

Keywords: toddlers pandemic healthcare workers socioemotional development sleep
human repeat insult patch test to evaluate personal lubricants

Conditions: Erythema; Edema

Summary: the purpose of this test is to evaluate the sensitizing potential of a personal lubricant, as a result of repeated occlusive patch. the intervention will be applied for a total of 9 induction applications, followed by an approximately 2 week rest period, then followed by a 24-72 hour challenge applications.


Eligibility criteria:
inclusion criteria: * good health as determined from screener * signed and dated informed consent * signed and dated hipaa form exclusion criteria: * subjects on test at any other research laboratory or clinic * known allergy or sensitivity to cosmetics and toiletries, including sunscreens, adhesives and/or topical drugs * pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study * pre-existing other medical conditions (e.g. adult asthma, diabetes). * treatment with antibiotics, antihistamines or corticosteroids within two weeks prior to initiation of the test * chronic medication which could affect the results of the study (e.g., insulin, corticosteroids, antihistimines, steroidal or non-steroidal anti-inflammatory drugs \[except for therapeutic maintenance dosage of aspirin\], antibiotics, steroid inhalers, etc.) * known pregnant or nursing women