Kornimate/medical-research-clean huggingface dataset:
detemir: role in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: study of blood sugars in the children with type 1 diabetes mellitus (t1dm), who are given insulin detemir and a rapid acting insulin (aspart). it is hypothesized that there is no difference in the patterns of blood sugars when detemir is given in the same syringe or in separate syringes with rapid acting insulin.

one of the barriers to good glycemic control in children with type 1 diabetes is multiple daily insulin injections. mixing rapid-acting (detemir) and slow- acting insulins (aspart) in the same syringe would decrease the number of injections and may improve adherence this study hypothesized that slow-acting insulin detemir mixed with aspart would have equivalent effects on blood glucose versus giving them as separate injections in children with type 1 diabetes. eighteen pediatric subjects with type 1 diabetes (11 males and 7 females) were recruited. however only 14 subjects completed this 20-day, randomized, crossover, and open-labeled study. the subjects were randomly assigned to either study a (both insulin detemir and rapid acting insulin (rai)) or study b (either detemir or aspart) for the first 10 days. they were then crossed over for the last 10 days. each subject underwent 72 h of continuous glucose monitoring (cgm) during the last 72 h, for both study a and study b.data of 48 h from midnight of the 1st day to mid- night of the 3rd day of the 72-h (cgm) were used for analysis to ensure the same starting and ending times of monitoring for all subjects.sustained glucose values over time were calculated as area under the curve (auc), index of blood glucose control as m-value and glucose excursion as mean amplitude of glucose excursion (mage)

Eligibility criteria:
inclusion criteria: * subjects with antibody positive type 1 diabetes mellitus (t1dm) * on insulin glargine for at least 3 months * age 10-25 years * not on medications that may affect glucose concentrations * hemoglobin a1c (hba1c) of less than 9 % * body mass index (bmi) less than 95th % and more than 10th% * supportive family exclusion criteria: * subjects with undetermined diabetes or type 2 diabetes mellitus (t2dm) * unable to adhere to insulin regimen * positive urine pregnancy test

Keywords: blood sugar glycemic
decitabine+cladribine+cytarabine+granulocyte colony-stimulating factor (d-clag) for relapsed or refractory acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia

Summary: a prospective, single-arm, multicenter, exploratory study to evaluate the efficacy and safety of d-clag regimen in the treatment of relapsed or refractory acute myeloid leukemia


Eligibility criteria:
inclusion criteria: * acute myeloid leukemia (non-acute promyelocytic leukemia) must be diagnosed before enrollment. diagnostic criteria refer to who (world health organization) classification. * refractory or relapsed aml: refractory is defined as the failure of cr after 2 courses of standard induced remission therapy (2 courses of idarubicin+cytarabine (ia) regimen or 1 course of ia regimen + 1 course of high dose cytarabine); relapse is defined as the blast cells \>5% in bone marrow or presence of extramedullary leukemia for patient who achieved cr before. * age 18-70. * eastern cancer cooperation group (ecog) ≤2. * creatinine clearance ≥30 ml/min (estimated glomerular filtration rate (egfr) according to the cockcroft-gault formula or modification of diet in renal disease (mdrd) formula). * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤3× upper limit of normal range (uln), total bilirubin ≤2×uln. * echocardiography (echo) showed left ventricular ejection fraction (lvef)≥50%. * life expectancy \>8 weeks. * voluntarily sign the informed consent and understand and comply with the requirements of the study. exclusion criteria: * white blood cell (wbc) \> 50 \* 109 / l * patients who have received salvage treatment with d-clag. * current active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease according to the new york heart association (nyha) functional classification, or a history of myocardial infarction within 6 months prior to screening. * other serious diseases that may limit patient participation in the trial (e.g. progressive infections, uncontrolled diabetes). * pregnant or nursing women. * unable to understand or follow the research protocol or unable to sign the informed consent.
feasibility study of early return-home after colorectal surgery using a sensium® vital parameter monitoring device

Conditions: Premature Exit After Colorectal Surgery

Summary: the principal aim of this study is to evaluate the impact on length of stay of a return-to-home monitoring device versus enhanced rehabilitation after bowel resection surgery with anastomosis. the device sensium is a tool to monitor vital signs (respiratory rate, heart rate and temperature) by applying a connected skin patch in order to detect complications early.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. asa score 1-3 3. colonic or rectal resection with anastomosis 4. minimally invasive surgery 5. patient living close to the hospital (\<1 hour drive) 6. patient accompanied for 48 hours 7. body mass index \< 40 8. patient information and signature of consent 9. patient affiliated to a social insurance plan 10. a pregnancy test must be performed before inclusion in women of childbearing age. non-inclusion criteria: 1. socially isolated patient and/or no 3g cell signal 2. severe comorbidities defined as any of these characteristics: 1. severe malnutrition (albumin \<30g/l) 2. severe anemia \< 80 g/dl 3. insulin-dependent diabetes type 1 e. patient under anticoagulation f. severe renal insufficiency 3. history of psychiatric illness with medication requirements 4. persons referred to in articles l1121-5 to l1121-8 of the csp (corresponds to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, persons under legal protection) 5. patient not wishing to enter the study 6. patient in a period of exclusion from another study or ongoing participation in an interventional study exclusion criteria: 1. stoma preparation 2. per operative conversion to laparotomy 3. chung score \> 8
aneuploidies and different stimulation protocols

Conditions: Aneuploidy

Summary: our working hypothesis is that patients undergoing "in vitro" fertilization (ivf) with higher response to ovarian stimulation protocols recover a higher number of oocytes and, this elevated response could be translated into increased incidence of chromosomally abnormal embryos. our objective is to develop a prospective study on healthy young donors, with a previous cycle with high ovarian response (\>20 oocytes and/or e2 levels the day of the hcg injection \>3000 pg/ml), but without developing mild or severe hyperstimulation syndrome. after signing a proper written consent, these donors would agree to undergo two subsequent stimulation cycles following two different protocols. in one cycle the stimulation pattern would be similar to the previous one, with elevated response and, in another cycle the amount of gonadotropins would be cut down in order to obtain lower ovarian response. oocytes obtained in each cycle would be donated to anonymous recipients and after fertilization, embryo quality and chromosomal status of the resulting embryos would be evaluated. preimplantation genetic diagnosis (pgd) will be performed on day-3 embryos and chromosomes 13, 15, 16, 17, 18, 21, 22, x and y would be analyzed by fluorescence "in situ" hybridization (fish).


Eligibility criteria:
inclusion criteria: * healthy women between 18 - 29 * with previous cycle with standard dosis of gonadotrophin and high response to the treatment (\> 20 oocytes) * no symptom of ohss exclusion criteria: * donors with 2 previous miscarriages * pco * severe male factor

Keywords: ovarian hyperstimulation embryo aneuploidy ovarian hyperstimulation and embryo aneuploidy rates
functional electrical stimulation mediated neuroplasticity: lower extremity ccnmes in stroke

Conditions: Stroke; Hemiparesis; Footdrop

Summary: this is a small pilot randomized controlled trial which will enroll both subacute (\ 6 mos) stroke survivors with ankle dorsiflexion weakness. the subjects will be randomized to contralaterally controlled neuromuscular electrical stimulation (ccnmes) versus control. the primary objective of this study is to compare the effect of 6-weeks of lower extremity ccnmes, applied in an anti-phase application, on motor impairment and functional mobility to a control group.


Eligibility criteria:
inclusion criteria: * age 21 to 75 years * minimum of 2 wks from a first clinical non-hemorrhagic or hemorrhagic stroke * medically stable * unilateral lower extremity hemiparesis * ankle dorsiflexor strength of ≤4/5 on the medical research council scale, while seated * nmes of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain. * full voluntary rom of the contralateral ankle * skin intact on bilateral lower extremities * able to don the nmes system or caregiver available to assist with device if needed. * able to hear and respond to stimulator auditory cues * able to follow 3-stage commands * able to recall 2 of 3 items after 30 minutes * cognition and communication adequate for safe use of the device based on neurological assessment by physician principal investigator exclusion criteria: * severely impaired cognition and communication * history of peroneal nerve injury * history of parkinson's, spinal cord injury, traumatic brain injury, or multiple sclerosis * uncontrolled seizure disorder * uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) * edema of the paretic lower extremity * absent sensation of paretic lower extremity * evidence of deep venous thrombosis or thromboembolism * history of cardiac arrhythmias with hemodynamic instability * cardiac pacemaker or other implanted electronic system * botulinum toxin injections to any lower extremity muscle in the last 3 months * pregnancy * symptomatic peripheral neuropathy * current use of psychoactive medications (except selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor antidepressants) * acetylcholinesterase inhibitor usage * unstable asthmatic condition * metallic implants (including clips and/or wires) * prosthetic heart valves * cardiac, renal or other stent * history of claustrophobia * low visual acuity * body weight or body habitus not compatible to mri machine * medical, psychological, or social concern identified by the principal investigator or co-investigator which suggests inappropriateness of subject participation

Keywords: stroke hemiplegia footdrop electrical stimulation
real-world study of iruplinalkib in the treatment of alk-positive non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: this study is a national multicenter real-world investigation aimed at evaluating the real-world effectiveness and safety of iruplinalkib in the treatment of alk-positive nsclc in china. the study aims to enroll alk-positive nsclc patients who have undergone treatment with iruplinalkib prior to enrollment. demographic information, medical history, iruplinalkib-containing treatment regimens, clinical outcomes, adverse events, and related data will be collected for all enrolled patients. as this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. the primary sources of data for this study will mainly consist of patients' routine medical records or healthcare documentation.


Eligibility criteria:
inclusion criteria: * patients willingly contribute their clinical data for this study * patients with alk-positive non-small cell lung cancer * age ≥ 18 years * patients who have undergone treatment with iruplinalkib. exclusion criteria: * known pregnant or lactating females * patients with interstitial lung diseases, drug-related pneumonitis, or radiation pneumonitis require ongoing medical intervention.
zinc supplementation in pediatric sepsis

Conditions: Zinc in Pediatric Sepsis

Summary: a single blinded randomized controlled clinical trial that was conducted to evaluate the role of zinc supplementation in improving the outcome of infants and children with sepsis in pediatric intensive care unit.

a single blinded randomized controlled clinical trial that was conducted to evaluate the role of zinc supplementation in improving the outcome of infants and children with sepsis in pediatric intensive care unit. the study included 72 cases that were randomly divided into 2 groups a- group a (zinc treated group): included 36 cases who received oral zinc sulfate supplementation at doses ranging from 10 mg (infants) to 20 mg (under-five children) of elemental zinc per day, a dosage that is safe in these children. b- group b: included 36 cases who didn't receive zinc sulfate supplementation. method of randomization: the cases were randomly divided into two groups using the closed envelope technique. the numbers from 1 to 72 were written in flat pieces of papers and put in closed envelopes that were randomly distributed to the participants. the cases with the odds number were allocated to the zinc treated group while the cases with the even numbers were allocated to the other group.

Eligibility criteria:
inclusion criteria: * 2- pediatric patients who fulfill pediatric consensus criteria for definition of severe sepsis as 1) greater than or equal to 2 age-based systemic inflammatory response syndrome criteria, 2) confirmed or suspected invasive infection, and 3) cardiovascular dysfunction, acute respiratory distress syndrome, or greater than or equal to 2 organ system dysfunctions exclusion criteria: * infants and children with history of prematurity (\< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, surgical conditions and any other chronic medical condition. * those who are regularly taking vitamin or mineral supplementations
effectiveness of telephone intervention for colorectal cancer caregivers

Conditions: Psychological Stress

Summary: the purpose of this study is to assess the effectiveness of the telephone intervention program for caregivers of colorectal cancer.

telephone intervention refer to provide counseling and education to caregivers of colorectal cancer by mode of telephone

Eligibility criteria:
inclusion criteria: * family members with newly diagnosed colorectal cancer within the past 4 week and treated in queen mary hospital * self identified as formal or informal family caregivers * over 18 years old * chinese * cantonese speaking exclusion criteria: * cognitive disability * domestic helpers or maids * non chinese

Keywords: quality of life anxiety stress carers colorectal or colon cancer
pulmonary arterial pressure response during exercise

Conditions: COPD Patients; Healthy Subjects; Semi-supine Echo (SSE); Flow-mediated Vasodilatation (FMD); High Sensitive C-reactive Protein (hsCRP)

Summary: background: the extent of increase in systolic pulmonary arterial pressure (paps) during exercise in patients with copd is unpredictable from lung function data. the non-invasive assessment of pulmonary hemodynamics during exercise and flow-mediated vasodilatation measurement may give useful data in the rehabilitation of copd patients. methods: patients with stable, severe copd and healthy, age-matched subjects (h) perform semi supine echocardiography with paps measurement. copd patients perform ramp protocol with gas exchange detection. serum hscrp level is also determined in copd patients. endothel dysfunction is detected by flow mediated vasodilation measurement after arm strangulation with doppler ultrasonography. primary endpoint: the degree of pulmonary artery systolic pressure change during exercise? secondary endpoint: 1. the degree of right ventricular function change during exercise? 2. is endothel dysfunction manifested with pulmonary artery pressure rise? 3. what is the correlation between the systemic inflammatory marker hscrp and the degree of pulmonary artery pressure rise?

background: the extent of increase in systolic pulmonary arterial pressure (paps) during exercise in patients with copd is unpredictable from lung function data. the non-invasive assessment of pulmonary hemodynamics during exercise by semi-supine echocardiography and flow-mediated vasodilatation measurement may give useful data in the rehabilitation of copd patients. methods: patients with stable, severe copd and healthy, age-matched subjects (h) perform semi supine echocardiography with paps measurement. copd patients perform ramp protocol with gas exchange detection. serum hscrp level is also determined in copd patients. all of the subjects perform complete lung function with body pletysmography and diffusion capacity measurement. endothel dysfunction is detected by flow mediated vasodilation measurement after arm strangulation with doppler ultrasonography.

Eligibility criteria:
inclusion criteria: * copd patients (age between 45 and 70) * with moderate to severe obstruction (fev1\<60%pred) and * healthy subjects (age between 45 and 70, (fev1\>80%pred, fev1/fvc\>70% exclusion criteria: * not in the age range * different fev1 value * severe comorbidities

Keywords: copd healthy patients pap cpx sse hscrp fmd
clinical evaluation of medasense pain monitor performances

Conditions: Surgery; Pain; Postoperative Pain

Summary: in this study, the performances of medasense's non-invasive pain monitoring is compared with standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with a subjective pain level assessment. the subjective pain level is assessed by the anesthesiologist when the patient is under general anesthesia and by the patient and a nurse in post anesthetic care unit (pacu). the study is based on recording and analyzing the subject's physiological signals, while recording painful events, medication dosing and different clinical signs.

pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. since pain is a subjective phenomenon, it has frequently defied objective, quantitative measurements. today, in order to measure pain, subjective uni-dimensional scales are used to quantify pain. one of the most common scale used to rate a patient's pain intensity is the visual analog scale (vas), usually scored from 0 to 100. hitherto, those scales are based on the subjective evaluation of pain by the patient. during anesthesia the patient cannot communicate and therefore the verbal or other report is impossible. therefore, due to misrepresentation of the existence or extent of pain, care providers may fail to estimate the correct measure of pain and give too much or too little medication. a scoring system of pain level is therefore needed. that is the problem medasense's system tries to approach. in this study investigators intend to test and analyze the performances of medasense pain monitor by comparing its results with standard pain related indicators and with subjective patient's pain level assessment. the patient's pain level will be assessed by the anesthesiologist during surgery based on known pain stimuli, medications administered and clinical signs, and by the pacu nurse and patient's reports, when the patient is in recovery.

Eligibility criteria:
inclusion criteria: * asa physical status 1-2 * elective surgery under general anesthesia * baseline blood pressure \< (170\\100 mmhg), heart rate \< 100 bpm exclusion criteria: * pregnancy or lactation * history of severe cardiac arrhythmias * presence of any neuromuscular or neurological disease * use of central nervous system (cns) -active medications * abuse of alcohol or illicit drugs * history of mental retardation or any mental disease * any severe lung, liver, renal disease and uncontrolled diabetes mellitus * use of a α or β-adrenergic antagonist or anticholinergics * allergy to any of the drugs to be used during surgery * use of regional anesthesia
randomized trial with dendritic cells in patients with metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the different alternatives used since 1996 to treat metastatic colorectal cancer (mcrc) have increased the mean survival of these patients. this outstanding advance is due to the extended indications for resection of hepatic metastases and to the use of new chemotherapeutic drugs (fluoropyrimidine, irinotecan and oxaliplatin) and monoclonal antibodies (bevacizumab, cetuximab and panitumumab). however, none of these treatments is curative and the majority of patients are overwhelmed by the illness. the first line of treatment for mcrc is folfox and the second, irinotecan plus cetuximab for patients with wild type kras gene (60%) with a 30% responses, and bevacizumab plus irinotecan with a 5-10% of responses, in patients with mutated kras (40%). a treatment with autologous dendritic cells (dcs) pulsed with autologous tumour antigens is proposed as a third line of therapy. a randomized phase ii trial would be performed, by selecting two groups of patients, one of them would be treated with the best supportive treatment and the other with dcs plus the best supportive treatment. the aim of the study would be to analyze the outcome after 4 months of treatment. in patients treated with dcs, ifn-γ spot forming cells and proliferative responses would be determined pre and post treatment in lymphocytes stimulated with autologous dcs pulsed with autologous tumour antigens. pre and post treatment serum levels of ifn-γ, tnf-α, tgf-β e il-12, would also be measured.


Eligibility criteria:
inclusion criteria: * age over 18 years. * capacity of understanding and signing the informed consent and to undergo the study procedures. * previously treated with 2 lines of chemotherapy. * ecog \<= 2. * adequate renal, hepatic and bone marrow function * confirmed diagnosis of colorectal cancer with hepatic metastasis, suitable for biopsy. * availability of tumor tissue, for maturing dendritic cells * recist.1 criteria exclusion criteria: * clinically relevant diseases or infections (hbv, hcv, hiv). * pregnant or breast feeding women. * immunosuppressant treatment. * concurrent cancer, with the exceptions allowed by the principal investigator (pi).

Keywords: colorectal neoplasms dendritic cells
inform and reduce pre-surgical anxiety of the child and his parents: interest of an explanatory movie.

Conditions: Anxiety Linked to the Surgery and / or Anesthesia

Summary: the purpose of the study is to measure the interest of a movie explaining the path of the children in surgery, in order to reduce the anxiety of the children and his parents. this study is interventional, method randomized, controled, open-label, comparing two parallel arms: anesthesist explanations versus anesthesist explanations + a movie explanation.


Eligibility criteria:
inclusion criteria: * patient who need a surgery * patient that general condition fit with american society of anesthesiologists (asa) i to iii classification. * old patient under age 12 * patient whose parents agreed to participate exclusion criteria: * patient with psychomotor limitations * patient that had already been hospitalised for a surgery

Keywords: children