Kornimate/medical-research-clean huggingface dataset:
effects of empagliflozin on endogenous glucose production in end stage renal disease(esrd).

Conditions: End Stage Renal Disease

Summary: a study of the effects of empagliflozin, a sglt-2 inhibitor, on endogenous glucose production and plasma glucagon levels in patients with end-stage renal disease (esrd)

the impact of sglt-2 inhibition on endogenous glucose production and plasma glucagon levels will be compared measured in patients with esrd.the secondary endpoints are the mean difference in plasma glucose, insulin, c-peptide, ffa,gh, epinephrine, norepinephrine, cortisol and blood pressure during the last hour of the experiment between empagliflozin versus placebo administration in patients.

Eligibility criteria:
inclusion criteria: 1. males and females 2. age = 30-70 years 3. bmi\&lt; 40 kg/m 2 and stable weight (± 3 lbs) over the preceding three months 4. normal glucose tolerance (hba1c \&gt; 4.5 % and \&lt; 5.7%) or type 2 diabetes (hba1c \&gt;5.7 % and \&lt;10.0%) 5. end stage renal disease (gfr \&lt;15 ml/min/1.73 m 2 or hemodialysis) 6. subjects are capable of giving informed consent exclusion criteria: 1. prednisone treatment 2. beta blocker or any medication that affects sympathetic/parasympathetic activity 3. known empagliflozin excipient hypersensitivity 4. liver function enzymes higher more than two times the upper limit 5. ongoing urinary tract infection 6. history of cancer of any type; 7. cerebrovascular or symptomatic peripheral vascular disease; 8. heart disease class iii or iv nyha; 9. type 1 diabetes 10. drug or alcohol abuse; 11. life expectancy \&lt;3 yrs 12. blood pressure \&gt;150/100 mmhg 13. donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of \&gt; 400 ml of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter 14. women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment) 15. patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures
developing mental health supports for autistic students

Conditions: Autism Spectrum Disorder; Depression, Anxiety

Summary: the present study aims to expand the availability of emotional supports in order to promote successful transitions and longer-term outcomes for autistic students in pse.

this study has three specific aims: aim 1: identify mental health needs of autistic students to inform supports. focus groups engaging key stakeholders will be used to understand the mental health needs of autistic college students and inform adaptation of two individualized mental health supports: 1) the esp intervention and 2) protocols for monitoring mood and psychological distress. aim 2: develop resources to inform and guide mental health care of autistic students. focus group information will inform 1) adaptation of clinician (esp-c) and self-guided (esp-s) emotional support plans and monitoring protocols and 2) develop a "college student mental health guide" to aide autistic college students, their families and mental health professionals in proactive planning for mental health supports during pse. aim 3: assess the feasibility, acceptability and initial efficacy of the esp-c and esp-s. the study will yield preliminary data to apply for additional funding to conduct a large-scale trial to validate these methods to monitor and support mental health of autistic adults. information gathered from the study will also be used to inform development of a mental health guide for autistic students.

Eligibility criteria:
inclusion criteria: * previous asd diagnosis, * has smartphone (to access the esp app) * at least 6th grade reading comprehension on the wrat-5. the wrat-5 may not be required if a student has other evidence of age-appropriate reading level. * be currently enrolled in a postsecondary education (pse) institution. exclusion criteria: * not a students in a pse institution or do not have diagnosis of asd * score below a 6th grade reading comprehension on the wrat-5 * unable to understand english * no access to a compatible ios and android smartphone * the pi's clinical judgment that it would not be in the adult's best interest to be enrolled

Keywords: smartphone ecological momentary intervention (emi) ecological momentary assessment (ema)
dhplc determination of tpmt polymorphisms.

Conditions: Acute Lymphoblastic Leukemia

Summary: tpmt is a key enzyme in the metabolism of thiopurines. tpmt polymorphisms have been described and are associated with a decrease activity of such enzyme. therefore, a higher risk of developing toxicity is present in patients requiring these drugs, which are indicated in acute lymphoblastic leukemia, as well as, immunosuppressors after organ transplantation. the frequency of heterozygotes polymorphisms ranges from 3 till 12 %, in different populations. homozygous patients have a lower frequency, estimated 1 in 300 individuals. the frequency of such polymorphisms in mestizos mexican population has not been analyzed, and we considered important to determine this frequency in healthy and patients requiring thiopurines, particularly acute lymphoblastic leukemia.

objectives: determine by dhplc analysis the frequency of tpmt polymorphisms in mestizos mexican population with acute lymphoblastic leukemia. * to do a clinical correlation between the presence of polymorphism and thiopurine related- myelotoxicity. * inclusion criteria: healthy volunteers or patients with acute lymphoblastic leukemia, age \> 18 years, who attend to the national institute of cancerologia. * exclussion criteria: patients with all, who are unable to have an adequate follow-up. * samples: genomic dna from peripheral blood leukocytes was isolated by standard methods. known (wild-type and polymorphic) sequenced polymerase chain reaction (pcr) fragments of the tpmt gene were used as controls. tpmt gene fragments were amplified. pcr products were then analyzed by denaturating high performance liquid chromatography (dhplc).

Eligibility criteria:
inclusion criteria: * healthy and patientes with acute lymphoblastic leukemia. * age: older than 18 years. * attend to the national institute of cancerologia exclusion criteria: * foreign patients with an irregular attendance to the national institute of cancerologia

Keywords: thiopurines thiopurine methyl transferase toxicity pharmacogenomics
bone scintigraphy and unicompartimental knee arthroplasty

Conditions: Bone Scintigraphy and Knee Arthroplasty

Summary: study the potential interest of bone scintigraphy for patients undergoing unicompartmental knee arthroplasty

knee osteoarthritis is a very common disease with significant functional consequences. surgical treatment is the ultimate treatment with the possibility of replacing only one compartment or the 3 joint compartments. consequently, the pre-surgical imaging is essential to ensure that the 3 compartments are not compromised when a uni-compartmental prosthesis (puc) is considered. the scintigraphy because of its good diagnostic performance seems to be interesting in this indication for the preoperative assessment of knee uni-compartmental prostheses to ensure the absence of degenerative lesion of the unoperated compartment. this study will evaluate the impact of bone scintigraphy on surgery and the potential correlation between scintigraphic and clinical data; study the pronostic impact of bone scintigraphy

Eligibility criteria:
inclusion criteria: * patient over 18 years old / uni or bilateral unicompartmental knee prothesis/ non opposition exclusion criteria: * under 18 years old/ contraindications for bone scintigraphy/ refusal to participate

Keywords: bone scintigraphy knee arthroplasty spect-ct quantification
a two-part study to assess the safety, tolerability, pk and pd of ono-7684 in healthy adult volunteers

Conditions: Venous Thromboembolism

Summary: this is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ono-7684 in healthy adult volunteers. this study will be conducted in 2 parts: part a is a single-ascending dose and part b is a multiple-ascending dose.

this study aims to obtain safety, tolerability, pharmacokinetic and pharmacodynamic data when ono-7684 is administered orally as single doses and as multiple doses to healthy subjects. the study will consist of 2 parts: a single ascending dose (sad) phase (part a); a multiple ascending dose (mad) phase (part b). one cohort of part a will receive ono-7684 under both fasted and fed conditions to investigate the effect of food.

Eligibility criteria:
inclusion criteria: 1. 18-55 years 2. normotensive male volunteers, or female volunteers of non-childbearing potential (part b only) 3. body mass index 18.0-30.0 kg/m2 4. deemed healthy on the basis of a clinical history, physical examination, ecg, vital signs, and laboratory tests of blood and urine 5. registered with a general practitioner (gp) in the uk 6. agree to use an effective method of contraception 7. able to give fully informed written consent exclusion criteria: 1. positive tests for hepatitis b \& c, hiv 2. severe adverse reaction to any drug 3. sensitivity to trial medication 4. drug or alcohol abuse 5. current smoker or use of nicotine containing products in the previous 6 months 6. vegetarians or vegans, or unwilling to eat a high-fat breakfast (part a food effect cohorts only) 7. use of strong cyp3a4/5 or p-glycoprotein inhibitors or inducers, anticoagulants, antiplatelet agents, non-steroidal anti-inflammatory drugs and/or acetylsalicylic acid within the previous 30 days 8. prescription or over-the-counter medication, vitamins, herbal treatments or dietary supplements within the previous 7 days (with the exception of paracetamol \[acetaminophen\]) 9. participation in other clinical trials of unlicensed medicines, or loss of more than 400 ml blood, within the previous 3 months or plan to donate blood or blood products in the 3 months after the trial 10. vital signs outside the acceptable range 11. clinically relevant abnormal findings at the screening assessment (including creatinine clearance, haemoglobin levels and qtcf) 12. acute or chronic illness 13. clinically relevant abnormal medical history or concurrent medical condition 14. objection by gp 15. possibility that volunteer will not cooperate 16. pre-menopausal females who are pregnant or lactating, or who are of childbearing potential
crocin supplementation in cscr

Conditions: Chorioretinopathy, Central Serous

Summary: preclinical and clinical evidence support the protective effect of crocin on different pathologic pathways involved in central serous chorioretinopathy (cscr). they involve inflammation, oxidative stress, mineralocorticoid pathway, and also stress-related injuries. it also showed that crocin has a protective effect on the retinal pigmented epithelium (rpe) layer. based on the mentioned evidence the study designed to evaluate the efficacy and safety of 2-month crocin supplementation (15 mg/d) in 40 patients with cscr in a randomized controlled blinded clinical trial.


Eligibility criteria:
inclusion criteria: * age of 18-60 years old * the diagnosis of cscr based on clinical and imagining evaluation * informed consent exclusion criteria: * chronic cscr * laser treatment (6 months prior to enrollment) * ivb treatment (3 months prior to enrollment) * other retinal diseases * history of eye diseases * diabetes mellitus * renal or hepatic diseases * allergy to saffron or crocin * pregnancy or lactation * beta-blocker, diuretic, or corticosteroid (1 week prior to enrollment) bleeding tendency or any coagulation disorder
mental imagery therapy for autism (mita) - an early intervention computerized language training program for children with asd

Conditions: Autistic Disorder; Autism; ASD

Summary: mental imagery therapy for autism (mita) is a unique, early-intervention application for children with autism spectrum disorder (asd). the app includes bright, interactive puzzles designed to help children learn how to mentally integrate multiple features of an object, an ability that has proven to lead to vast improvements in general learning. success with mita puzzles could overtime result in significant improvements in a child's overall development, specifically in the realms of language, attention and visual skills. science behind the project: mita verbal activities start with simple vocabulary-building exercises and progress towards exercises aimed at higher forms of language, such as noun-adjective combinations, spatial prepositions, recursion, and syntax. for example, a child can be instructed to select the {small/large} {red/ blue/green/orange} ball or to put the cup {on/under/behind/in front of} the table. all exercises are deliberately limited to as few nouns as possible since the aim is not to expand a child's one-word vocabulary, but rather to teach him/her to integrate mental objects in novel ways using active imagination. mita nonverbal activities aim to provide the same active imagination training visually through implicit instructions. e.g., a child can be presented with two separate images of a train and a window pattern, and a choice of complete trains. the task is to find the correct complete train and place it into the empty square. this exercise requires not only attending to a variety of different features in both the train and its windows, but also combining two separate pieces into a single image (in other words, mentally integrating separate train parts into a single unified gestalt). as levels progress, the exercises increase in difficulty, requiring attention to more and more features and details. upon attaining the most difficult levels, the child must attend to as many as eight features simultaneously. previous results from our studies have demonstrated that children who cannot follow the explicit verbal instruction can often follow an equivalent command implicit in the visual set-up of the puzzle. as a child progresses through mita's systematic exercises, he or she is developing the ability to simultaneously attend to a greater number of features, reducing the propensity towards tunnel vision, and thus developing an essential component of language. the ability to mentally build an image based on a combination of multiple features is absolutely necessary for understanding syntax, spatial prepositions and verb tenses. mita is designed for early childhood and intended for long-term, daily use. it is designed to be engaging and educational, as well as adaptive and responsive to the individual abilities of each child.


Eligibility criteria:
inclusion criteria: autism spectrum disorder exclusion criteria: none
influence of neostigmine vs. sugammadex on porc and ppcs by ultrasonography

Conditions: Postoperative Pulmonary Complications

Summary: this trial aims to compare the incidence of postoperative residual curarisation (porc) and postoperative pulmonary complications (ppcs) in the sug and neo group by means of diaphragm ultrasonography and lus, so as to conclude whether sug can outperform neo in preventing occurrence of porc and ppcs.

the incidence of postoperative residual curarisation (porc) is about 2%-64% worldwide, which may be an underling risk factor of postoperative pulmonary complications (ppcs), causing many undesirable effects on patients. thus, reversal drugs of neuromuscular blocking agents (nmbas) such as neostigmine (neo) and sugammadex (sug) have been administrated, and sug maybe perform better in preventing porc. different supplementary methods to help identify porc or ppcs have also been reported, such as adductor of pollicis acceleromyography and lung ultrasound (lus). recently, diaphragm ultrasonography has been used to evaluate porc, as a novel approach.in this prospective, double-blind, randomized controlled trial, we will enroll 414 patients of american society of anesthesiologists physical status i-iii, aged over 60 years, who will be scheduled to undergo arthroplasty surgery under general anesthesia. participants will be randomized into neo and sug group receiving neostigmine and sugammadex as reversal drug respectively. the primary outcomes will be the incidence of ppcs in neo and sug group respectively. the secondary outcome is the incidence of porc in the two groups.we hypothesize that: 1) the incidence of ppcs is lower after reversal with sug than with neo, 2) using the method of diaphragm ultrasonography, the incidence porc is lower after reversal with sug than with neo, 3) the incidence of ppcs can be predicted by lus and by evaluating whether there is porc through diaphragmatic ultrasound.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists (asa) physical status i-iii 2. aged over 60 years 3. anesthesia induction with rocuronium as nmbas, maintenance with volatile sevoflurane 4. scheduled to undertake joint surgery 5. signed the informed consent form exclusion criteria: 1. those with a history of hepatic or renal disease, chronic or acute alcoholism, allergy or hypersensitivity to sugammadex or neostigmine, current medication with effects on the central nervous system, a history of dysfunction of neuromuscular system 2. those with diaphragm insufficiency or massive pleural effusion 3. women who are pregnant or nursing 4. those undergoing upper abdominal laparotomy, after which we cannot obtain a satisfactory ultrasound imaging or do not have space for placement of ultrasonic probe 5. declined to participate

Keywords: postoperative pulmonary complications postoperative residual curarisation lung ultrasound diaphragm ultrasonography
a clinical trial of chidamide combined with etoposide in relapsed or refractory nk/t-cell lymphoma

Conditions: NK/T-Cell Lymphoma

Summary: to observe the safety, tolerability and clinical effects of chidamide combined with etoposide in relapsed or refractory nk/t-cell lymphoma.

this is a prospective, open-label, one-arm, single center clinical trial, aimed to evaluate the safety, tolerability, and efficacy of chidamide combined with etoposide in relapsed or refractory nk/t-cell lymphoma. a total of 30 patients are planned to be enrolled into the study. patients with diagnosis of relapsed or refractory nk/t-cell lymphoma will be treated with chidamide plus etoposide capsules. the primary end points are objective responder rate (orr) and a time to response(ttr) and response duration (dor) and progression free survival(pfs) and adverse events.

Eligibility criteria:
inclusion criteria: 1.age:10-65 years;eastern cooperative oncology group (ecog)score≤2;expected survival≥3 months 2 patients with nk/t cell lymphoma diagnosed by immuno-histochemistry (ihc) or fluorescence in situ hybridization (fish); 3.refractory or relapse after at least 2 regimen 4.once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence; 5.no chemotherapy contraindications: hemoglobin ≥ 100g / l, absolute neutrophil count ≥ 1.5 × 109 / l, platelets ≥ 80 × 109 / l, alt, ast ≤ 2 times the upper limit of normal, serum total bilirubin ≤ 1.5 times normal upper limit, serum creatinine ≥ 1.5 times normal upper limit, serum protein ≥ 30g / l; 6.at least one measurable lesion 7.there are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal; 8.women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication; 9.there is no other antitumor treatment, but bisphosphonate for anti-bone metastasis treatment and other symptomatic treatment can be applied. 10.can understand the situation of this study and sign the informed consent voluntarily exclusion criteria: 1. rejecting providing blood preparation; 2. allergic to drug in this study or with hemophagocytic syndrome; 3. rejecting adopting reliable contraceptive method in pregnancy or lactation period; 4. uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas）； 5. with severe infection; 6. with primary or secondary central nervous system tumor invasion; 7. with chemotherap or radiotherapy contraindication; 8. ever suffered with malignant tumor; 9. human immunodeficiency virus (hiv)-positive patients 10. drug abuse or long-term alcohol abuse that affects the evaluation of test results; 11. have peripheral nervous system disorder or mental disorder; 12. those who have no legal capacity or whose research is affected by medical or ethical reasons;

Keywords: chidamide combined with etoposide orr cr pr ttr dor pfs
depression inventory for maintenance hemodialysis patients

Conditions: Depression; Hemodialysis Complication; Management; Risk Behavior

Summary: depression is frequently seen among hemodialysis patients; however, it causes an impaired quality of life, a decrease in adherence to treatment, and an increase in hospitalization and mortality rate. it has been stated in the literature that the prevalence rate of depression in hemodialysis patients varies between 25-73%. despite its high prevalence rate and adverse effects, it has been revealed that only a low rate of patients with depressive symptoms are diagnosed and treated. this is primarily associated with the fact that depressive symptoms in patients are not adequately recognized and examined.

depression is assessed through structured clinical interviews or diagnostic scales. structured clinical interviews are often regarded as the "gold standard" for the diagnosis of depressive disorders, since they are based on specific diagnostic criteria. however, since it is not always possible for patients to be evaluated by a psychiatrist, some scales are used instead. even though these scales are not a diagnostic criterion, they are helpful in identifying patients at risk . however, screening may also result in false negatives, where cases of depression are not detected and, consequently, go untreated. patients with kidney failure differ from the general population because they experience higher rates of comorbid depression. indeed, there is a clear need for more effective screening tools for patients undergoing hemodialysis, given the wide variation in depression screening methods and the absence of a gold-standard assessment tool tailored to this specific population. developing an easily administered, disease-specific self-report measure for depression could prove to be highly beneficial. there is only one study that has examined a depression tool specifically designed for patients on maintenance dialysis, known as the depression inventory-maintenance hemodialysis (di-mhd)

Eligibility criteria:
inclusion criteria: * patients aged 18 years and older * patients who were receiving hemodialysis treatment for at least three months * patients could communicate in turkish * patients who agreed to participate in the study were included in the study. exclusion criteria: * patients who suffered from psychiatric disorders such as chronic psychosis and were previously diagnosed with depression were excluded from the study

Keywords: depression dialysis management