Kornimate/medical-research-clean huggingface dataset:
efficacy of flash glucose-sensing technology on the occurrence of cardiac arrhythmias associated with hypoglycemia

Conditions: Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia

Summary: hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with type 2 diabetes (t2d). the study hypothesize is that the hypoglycemia reduction, achieved with the freestyle libre device, a glucose continuous monitoring system, may decrease cardiac arrythmias associated with hypoglycemia. so the main objective is to evaluate the efficacy of the freestyle libre system, associated with a specific therapeutic education on the cardiac arrythmias reduction, compared to a capillary asg system with standard therapeutic education, in patient with t2d with high risk of hypoglycemia. this is a open, multicenter, controlled, randomized study in parallel group.


Eligibility criteria:
inclusion criteria: * type 2 diabetes (diagnosis based on the world health organization criteria) * treatment with insulin therapy (continuous subcutaneous insulin infusion or more than 1 daily injection) * resting heart beat ≥ 60bpm * high risk of hypoglycemia defined as : * estimated glomerular filtration rate 15-59 ml/min/1.73 m² (according to ckd-epi formula) * or history of stable proliferative diabetic retinopathy * or body mass index ≤ 30 kg/m² * or history of severe hypoglycemia in the previous 6 months * or history of non-severe ≤70mg/dl hypoglycemia in the previous 4 weeks exclusion criteria: * type 1 diabetes mellitus or diabetes due to other cause * history of atrial fibrillation * pacemaker * estimated glomerular filtration rate \<15 ml/min/1.73 m² (according to ckd-epi formula) * currently using a flash continuous glucose monitoring device * in the investigator's opinion, acute or chronic medical condition considered as unsuitable for inclusion in the study .

Keywords: freestyle libre type 2 diabetes hypoglycemia-induced cardiac arrhythmias flash continuous glucose monitoring
comparative study of two recombinant human erythropoietin products in chronic kidney disease patients

Conditions: Anemia of Chronic Kidney Disease

Summary: phase iii, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of megalabs® recombinant human alfa epoetin for intravenous use, compared to epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis

patients with chronic kidney disease undergoing hemodialysis will be administered human recombinant alfa epoetin to revert anemia. hemoglobin, hematocrit and reticulocyte counts will be assessed. immunogenicity will be evaluated through bi-weekly anti drug antibody determination. test drug and comparator drug will be compared to evaluate biosimilarity.

Eligibility criteria:
inclusion criteria: * stage v chronic kidney disease undergoing hemodialysis exclusion criteria: * lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies
china betaferon adherence, coping and nurse support study

Conditions: Multiple Sclerosis, Chronic Progressive

Summary: non-adherence reduces treatment benefit and can bias the assessment of treatment efficacy thereby involving safety risks for the patient and influencing health cost-effectiveness. this observational study will concentrate upon the role of ms nurses in influencing adherence. this study will examine the influence of initial and subsequent periodic nurse interviews which aim to improve adherence to betaferon® treatment.


Eligibility criteria:
inclusion criteria: * relapsing-remitting multiple scelrosis (rrms) and secondary progressive multiple sclerosis (spms) patients * having betaferon treatment, including patients who are * first time using; or * re-staring; or * switching from other diseases modifying drugs (dmds) exclusion criteria: * known or newly identified contraindication for administration of betaferon according to summary of product characteristic (smpc).

Keywords: relapsing-remitting multiple sclerosis secondary progressive multiple sclerosis
acupuncture for enhancing immunotherapy in advanced nsclc：a pilot study

Conditions: Non-small Cell Lung Cancer; Non-Small-Cell Lung Carcinoma

Summary: this multicentre, randomized controlled trial evaluates the effect and safety of integrating acupuncture with immunotherapeutic sensitization in treating nsclc. participants will be randomly assigned to undergo either acupuncture or sham acupuncture concurrent with the initial four cycles of standard icis combined with chemotherapy.


Eligibility criteria:
inclusion criteria: 1. has a histologically-confirmed or cytologically confirmed diagnosis of stage iiib or iv nsclc. 2. pd-l1 tps\<50% 3. egfr/alk wild-type 4. has not received prior systemic treatment for advanced nsclc. for patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy or radical chemoradiotherapy, if the disease progresses occurred one six months after the last treatment, they can be enrolled. patients who received targeted therapy or immunotherapy can not be enrolled. 5. has a performance status of 0-2 on the eastern cooperative oncology group (ecog) performance status. 6. age≥18 years 7. has a life expectancy of at least 3 months 8. has measurable disease 9. has adequate organ function 10. voluntarily enrolled into the study, sign the informed consent form and have good compliance exclusion criteria: 1. unable to complete baseline assessments 2. expected to receive radiotherapy within the next 4 cycles 3. with a combination of serious primary diseases of the heart, cerebrovascular, hepatic, renal, and hematopoietic systems 4. with dementia, neurological disorders, mental retardation, or language impairment, and pregnant or breastfeeding women 5. combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs 6. combined with a primary tumor from other sites 7. had participated in any other clinical trial within the prior 3 months 8. has known history of human immunodeficiency virus (hiv) or solid organ transplantation 9. with legal incapacity 10. with skin breakdown at the acupuncture point that interferes with treatment 11. with a pacemaker 12. with a fear of acupuncture 13. had received acupuncture treatment within 6 weeks 14. has known active hepatitis b 15. has interstitial lung disease or a history of pneumonitis that required oral of iv glucocorticoids to assist with management 16. has fever (\>38°c) or clinically significant infection within 1 week prior to enrolment 17. has active tuberculosis or indications of severe or uncontrolled systemic diseases 18. with a bleeding tendency, and receiving thrombolytics or anticoagulants

Keywords: non-small cell lung cancer acupuncture immune checkpoint inhibitors effect safety
a study to evaluate the nipocalimab and certolizumab combination therapy in participants with active rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis (ra) and meeting the 2010 american college of rheumatology (acr) or european league against rheumatism (eular) criteria for ra for at least 3 months before screening * has moderate to severe active ra as defined by persistent disease activity with at least 6 of 66 swollen joints and 6 of 68 tender joints at the time of screening and at baseline * is positive for anti-citrullinated protein antibodies (acpa) or rheumatoid factor (rf) by the central laboratory at the time of screening * has c-reactive protein (crp) greater than or equal to (\>=) 0.3 milligram per deciliter (mg/dl) by the central laboratory at the time of screening * if has received prior biological disease-modifying antirheumatic drugs (bdmards) (or biosimilars) other than anti-tumor necrosis factor (anti-tnf) agent in ra, has demonstrated inadequate response (ir) or intolerance to the therapy based on one of the following: 1. ir to at least 1bdmard (or the biosimilars) other than anti-tnf agents, as assessed by the treating physician, after at least 12 weeks of therapy including but not limited to abatacept, anakinra, tocilizumab, and sarilumab or at least 16 weeks of therapy with rituximab documented ir may include inadequate improvement or loss in response after initial improvement in joint counts or other parameters of disease activity 2. intolerance to bdmard (or biosimilars) other than anti-tnf agent, as assessed by the treating physician. documented intolerance includes side effects and injection or infusion reactions * if has received prior anti-tnf agent (including biosimilars), has demonstrated ir to \>=1 anti-tnf agent (including biosimilars), as assessed by the treating physician: 1. after at least 12 weeks dosage of etanercept, adalimumab, golimumab (including biosimilars), and/or 2. after at least 14 weeks dosage (example, at least 4 doses) of infliximab (including biosimilars) documented ir may include inadequate improvement or loss in response after initial improvement in joint counts or other parameters of disease activity exclusion criteria: * has a confirmed or suspected clinical immunodeficiency syndrome not related to treatment of ra or has a family history of congenital or hereditary immunodeficiency unless confirmed absent * is (anatomically or functionally) asplenic * has experienced myocardial infarction, unstable ischemic heart disease, or stroke less than or equal to (\<=) 12 weeks of screening * has a diagnosis of congestive heart failure including medically controlled, asymptomatic congestive heart failure * has a history of known demyelinating disease such as multiple sclerosis or optic neuritis
an open label study to evaluate the pharmacokinetics, safety, tolerability and efficacy of deferasirox administered to chinese patients with β-thalassemia major aged from 2 to less than 6 years old

Conditions: β-thalassemia Major

Summary: to characterize the pk of deferasirox in pediatric β-thalassemia major patients aged from 2 to less than 6 years old, when administrated with a fixed starting dose of 20 mg/kg/day.


Eligibility criteria:
inclusion criteria: * pediatric patients aged from 2 to less than 6 years old. * patients with transfusion dependent β-thalassemia major. * serum ferritin values ≥ 1000 ng/ml at screening. * written informed consent must be obtained from the patient's legal guardian in accordance with local law and regulation prior to any screening procedures. exclusion criteria: * non-transfusion-dependent thalassemia. * systemic diseases which would prevent study treatment (e.g. uncontrolled hypertension, cardiovascular, renal, hepatic, metabolic, etc.) * serum creatinine \> age adjusted uln. * significant proteinuria as indicated by a urinary protein/creatinine ratio (upcr) ≥ 0.5mg/mg in a non-first void urine sample at screening. if upcr is found to be ≥ 0.5 mg/mg the test can be repeated after 1 month. * alt/ast \> 2.5xuln and total bilirubin \> 1×uln. * left ventricular ejection fraction \< 56% by echocardiography. * patient has a known history of hiv seropositivity or history of active/treated hepatitis b or c (a test for screening is not required). * a history of clinically relevant ocular and/or auditory toxicity related to iron chelation therapy * any surgical or medical conditions which will significantly alter the absorption, distribution, metabolism or excretion of the drug(e.g. ulcerative disease, uncontrolled nausea, vomiting, malabsorption syndrome, obstruction, or stomach and/or small bowel resection). * other conditions which investigator deems potential harm to patients if participate the study.

Keywords: deferasirox
avapritinib in cbf-aml with kit mutations

Conditions: Core Binding Factor Acute Myeloid Leukemia; KIT Mutation-Related Tumors

Summary: aml with t(8; 21)(q22; q22) or inv(16)(p13; q22)/t(16; 16)(p13; q22) is known as cbf-aml. kit mutations are common in cbf-aml, which have a worse prognosis.this study is aimed to evaluate the efficacy of avapritinib, an highly specific inhibitor of the kit gene, in cbf-aml with kit mutations.

acute myeloid leukemia (aml) with the chromosomal abnormality of t(8; 21)(q22; q22) or inv(16)(p13; q22)/t(16; 16)(p13; q22) is known as the core binding factor aml (cbf-aml). kit mutation is a common mutation in cbf-aml, which is more likely to relapse and have a worse prognosis. avapritinib is an oral tyrosine kinase inhibitor (tki) with selective inhibitory activity against kit and pdgfra. avapritinib has been approved by fda for the treatment of gastrointestinal stromal tumors(gist) with pdgfra mutations and advanced systemic mastocytosis (advsm). however, the efficacy of avapritinib in aml with kit mutations is uncertain. this prospective, multicenter clinical study of the efficacy and safety of avapritinib in relapsed refractory or molecular minimal residual disease (mrd)-positive aml with kit mutations.

Eligibility criteria:
inclusion criteria: 1. patients with acute myeloid leukemia accompanied by t(8; 21)/runx1-runx1t1, or inv(16)/t(16; 16)/cbfβ-myh11; 2. accompanied by kit mutation 3. disease recurrence after the first remission, or the mol-mrd remains positive after the morphologic remission of aml. 4. no active infection. 5. liver function: tbil≤ 2×uln,alt/ast≤ 3×uln, ccr ≥ 50ml/min，nyha grading ≤2; sao2 \>92%. 6. ecog \<2; (11) predicted survival \> 12 weeks. exclusion criteria: 1. accept other aml targeted therapies, such as dasatinib, sorafenib, gilteritinib, etc. simultaneously; 2. the presence of uncontrolled and active infections (including bacterial, fungal or viral infections). 3. underlying diseases such as myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal failure, etc. 4. pregnant or lactating women; 5. accompanied by other malignant tumors requiring treatment; 6. other interventional clinical studies have been enrolled.
alprazolam as conscious sedation for upper gastrointestinal endoscopy

Conditions: Diagnostic Esophagogastroduodenoscopy

Summary: diagnostic esophagogastroduodenoscopy is an uncomfortable and stressful procedure for most of the patients. various methods are available for sedation during this procedure. because of some side effects related to intravenous administration of sedatives, oral administration of these drugs is under attention. alprazolam is a benzodiazepine which is used mainly in treatment of anxiety. hence, we determine the efficacy of oral and sublingual alprazolam as for sedation during this procedure. we hypothesize that sublingual alprazolam is more effective than that oral form and both forms more effective than placebo in reducing anxiety and pain/discomfort related to the procedure.


Eligibility criteria:
inclusion criteria: * referring for upper gi endoscopy * age 18 to 65 years * first experience of upper gi endoscopy * class i or ii of american anesthesiology association * willingness to participate exclusion criteria: * severe psychiatric, neurological, cardio-vascular, or renal disorders * history of allergy or intolerance to benzodiazepines or lidocaine * history of upper gi surgery * pregnancy or lactation * gi anomalia during endoscopy * need for therapeutic procedures during endoscopy * active bleeding

Keywords: pain discomfort anxiety satisfaction compliance
intraperitoneal chemotherapy versus triweekly chemotherapy

Conditions: Intraperitoneal Chemotherapy, Bevacizumab, Ovarian Cancer

Summary: the combination of paclitaxel and carboplatin is the standard first-line chemotherapy for ovarian cancer as recommended by the nccn guidelines for epithelial ovarian cancer, and is conventionally given via intravenous route every three weeks. the addition of target therapy (bevacizumab) has shown to improve progression free survival but not overall survival. several trials have also demonstrated a clinically significant survival advantage associated with intraperitoneal chemotherapy compared to intravenous chemotherapy, and the best outcomes are consistently seen for patients who have no residual disease. this study aims to compare triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy in patients with advanced stage ovarian cancer.


Eligibility criteria:
inclusion criteria: * women aged 20 and above with figo stage ii-iv advanced ovarian, fallopian tube or primary peritoneal cancer who received debulking surgery, followed by either triweekly intravenous chemotherapy with bevacizumab or intraperitoneal chemotherapy; women who received neoadjuvant chemotherapy followed by interval debulking surgery were also eligible for participation. intraperitoneal chemotherapy was defined as having one or more cycles of an intraperitoneal regimen administered. exclusion criteria: * women who quit half-way or received chemotherapy at other site
evaluating mepitel in post-mastectomy patients and the role of the skin microbiome in radiation dermatitis

Conditions: Breast Cancer

Summary: the aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. the study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis. the goal is to improve understanding of the mechanism of radiation dermatitis.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * histological confirmation of breast or chest wall malignancy * primary or recurrent disease eligible * post-mastectomy with or without reconstruction * undergoing unilateral external beam radiotherapy at the mayo clinic - rochester, mn or mayo clinic - eau claire, wi * ability to complete questionnaire(s) by themselves or with assistance * provide informed written consent * willing to consent for photography of radiation field * available to return to mayo clinic in within 6 weeks post-treatment for assessment * able to initiate thin film usage within first 3 days of the initiation of treatment exclusion criteria: * documented history of adhesive or tape allergy * unable to provide written consent * patients with prior radiotherapy to any portion of the planned treatment site * brachytherapy patients * patients with active rash, pre-existing dermatitis, lupus, or scleroderma * gross dermal involvement at initiation of radiotherapy * recent use of systemic or topical antibiotics or antifungal medications within 14 days of swab collection * recent use of any of the following within 14 days of swab collection: * systemic or topical steroids * use of systemic immunosuppressant drugs * use of ultraviolet light therapy * clinical evidence of infection that in the judgement of the principle investigator would interfere with proper assessment of the skin microbiome * prior organ or bone marrow transplant * current lactation * undergoing bilateral radiation
nurse-led rapid access chest pain clinic

Conditions: Chest Pain

Summary: this study aims to ascertain the lived experiences of 6 patients attending a nurse-led chest pain clinic via an interview, and to understand the demographics of referred patients.

a qualitative analysis of a nurse-led chest pain clinic will be undertaken to improve understanding of patient experience. patients who have used this service will be invited to take part in an interview. patients will be split in to two groups: those reassured and discharged after first attendance, and those who went on to have further diagnostic testing. the aim is to interview three patients from each group to compare experiences and perceptions of a service which previously would have been undertaken by physicians, but is now completely nurse-led.

Eligibility criteria:
inclusion criteria: * patients who have attended the chest pain clinic in the last four month months * eighteen years-of-age and older * able to give valid consent * english speaking exclusion criteria: * non-english speaking patients * patients under 18 years of age * patients with any cognitive impairment. * any vulnerable patients (defined by the mental health act 2005 as anyone lacking capacity to make decisions, ie, someone with severe impairment in the functioning of the brain). * offenders in the care of prison services (for logistical reasons)
effect of animated cartoon for prevention of emergence agitation in children aged 1.5 - 5 yr after general anesthesia

Conditions: Sevoflurane Anaesthesia

Summary: emergence agitation (ea) in children early after sevoflurane anaesthesia is a common postoperative problem, with incidence ranging up to 80%. younger patients, particularly in the age range from 1.5 to 5 yr of age, are at increased risk of ea. preoperative anxiety, as measured by the modified yale preoperative anxiety scale, has been shown to increase the risk of ea for each increment of 10 points in the child's state anxiety score. so, alleviates preoperative anxiety in children maybe decrease the incidence and severity of ea. preschool children enjoy watching animated cartoons, and they can be immersed to animated cartoon so they become oblivious of their surroundings. therefore, viewing an animated cartoon maybe reduce preoperative anxiety in children. this study was performed to determine effect of animated cartoon for prevention of emergence agitation in children aged 1.5 - 5 yr after general anesthesia


Eligibility criteria:
inclusion criteria: 1. pediatric patient (1.5-5yrs) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia exclusion criteria: 1. patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period

Keywords: animated cartoon, emergence agitation
glycemic index of cacao fruit pulp in healthy, human subjects

Conditions: Blood Sugar; High; Blood Sugar; Low

Summary: cacao fruit pulp is a sweet and fruity carbohydrate-rich edible mucilage that is often discarded. the objective of this study is to assess the glycemic response and determine the glycemic index of cacao fruit pulp.

in an acute, open-labeled, randomized design, individuals without diabetes were studied over 120 minutes after consuming 25 grams of available carbohydrate portions of cacao pulp or dextrose.

Eligibility criteria:
inclusion criteria: subjects were males or non-pregnant females and in good health. exclusion criteria: subjects with a known history of aids, hepatitis, diabetes or a heart condition. subjects taking medication or with any condition that might make participation dangerous to the subject, to others, or affect the results.