Kornimate/medical-research-clean huggingface dataset:
afamin in gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: this study includes pregnancies in 11 to 14 th gestational weeks. investigators will sample maternal plasma in the first trimester and analyze maternal plasma afamin values. all these women will then be screened by two step ogtt. investigators will compare afamin levels in gdm and control groups.

background gestational diabetes mellitus (gdm) is an endocrinopathy that occurs during pregnancy, and presents several clinical findings together with increased blood glucose levels. the frequency of gdm differs, while the incidence of the disease in turkey is reported to be 7%. most of the societies recommend screening all women with or without any risk factors in terms of gdm. the definitive diagnosis is made via oral glucose challenge test (ogtt). early diagnosis and treatment are the key points to improve maternal and fetal outcomes. different biomarkers are studied regarding gdm diagnosis starting from first trimester. however, there is not a worldwide accepted biomarker for defining the high risk group to the date. afamin is known as an important indicator of oxidative stress. moreover, oxidative stress itself is strongly associated with insulin resistance and obesity which are responsible from gdm pathogenesis. objective to investigate the association between first trimester maternal plasma afamin levels and gdm. also, investigators aimed to understand the role of afamin for the prediction of gdm in this study. methods this is an observational prospective cohort study conducted in department of perinatology, etlik zubeyde hanim women's health care, training and research hospital, university of health sciences, ankara, turkey. during 11 and 14 weeks of gestational, maternal blood will be obtained from eligible pregnant women, and samples will be stored at -80 oc. informed written consent will be obtained from participants. between 24th and 28th gestational weeks, all these women will be screened by two step ogtt. then, afamin levels will be compared in gdm and control groups. exclusion criteria are; multiple pregnancy, fetal anomalies, pregestational diabetes, underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders), age \ 35 years, fasting glucose level \> 105 mg/dl or random glucose level \> 200 mg/dl.

Eligibility criteria:
inclusion criteria: * singleton pregnancy, * having no fetal anomalies * having no pregestational diabetes * having no underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders) * age \>18 or \< 35 years * fasting glucose level \< 105 mg/dl exclusion criteria: * multiple pregnancy * fetal anomalies * pregestational diabetes * underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders) * age \ 35 years * fasting glucose level \> 105 mg/dl or random glucose level \> 200 mg/dl
an adaptive-design prospective cohort study of watch and wait strategy in patients with locally advanced rectal cancer

Conditions: Rectal Cancer

Summary: the study is designed to test the hypothesis that the clinical complete response (ccr) rate of patients with locally advanced rectal cancer (larc) treated with neoadjuvant chemoradiotherapy will increase after an adaptive-design paradigm, as well as the rate of 2-year organ preservation, recurrence, quality of life, dfs and os.

1. primary objective: evaluate the ccr rate of low rectal cancer using adaptive and optimized chemotherapy and radiotherapy strategies (all population and dmmr/msi-h subgroup) 2. secondary objectives: 2.1 evaluate the 2-year anal preservation rate, recurrence rate, quality of life, dfs and os 2.2 explore the subgroup of patients suitable for observation. 3. outline: patients after long-course chemoradiation are grouped based on their msi-h/dmmr status. for patients with msi-h/dmmr, consolidation immunotherapy of tislelizumab (bgb-a317) will be assigned. for patients with mss/pmmr, consolidation chemotherapy will be given according to their tumor response. after completion of consolidation therapy, those who reach clinical complete response will receive organ preservation (watch and wait) strategy in place of radical surgery. during treatment, once local regrowth occurs or poor tumor response, total mesorectal excision (tme) surgery will be performed.

Eligibility criteria:
inclusion criteria: * pathological confirmed adenocarcinoma * clinical stage t2-4 and/or n+, inappropriate for local excision * the distance from anal verge less than 5 cm, or considered inappropriate for anal preservation by surgeons. * strong desire to preserve the anus, able to receive close surveillance for at least 2 years after chemoradiotherapy. * without distance metastases * aged between 18 to 75 years old. * performance status score: 0\~1 * ugt1a1\*28 6/6 or 6/7 * sign the inform consent exclusion criteria: * pregnancy or breast-feeding women * serious medical illness * difficult to achieve complete response assessed by current evidence: the maximal diameter of tumor \>10cm; the maximal diameter of lateral lymph node \>2cm; baseline cea\>=100; biopsy pathology confirmed signet ring cell carcinoma components; digital rectal examination found that the tumor is peri-narrowed. * baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/l, hb≥90g/l, plt≥100×10\^9/l, alt/ast ≤2.5 uln, cr≤ 1 uln * dpd deficiency * ugt1a1\*28 7/7

Keywords: chemoradiotherapy organ preservation watch and wait irinotecan tislelizumab capecitabine
impact of volatile versus total intravenous anesthesia on postoperative delirium in elderly diabetic patients undergoing non-cardiac surgery: a multicenter, randomized controlled trial

Conditions: Postoperative Delirium (POD); Diabetes

Summary: the present study is a multicenter， randomized controlled clinical trial, which plans to enroll 450 diabetic patients aged more than 60 years. the participants will be randomly assigned in a 1:1 ratio and will receive either propofol or sevoflurane for intraoperative anesthesia maintenance to evaluate the impact of these two anesthetic drugs on postoperative delirium. the aim of our study is to explore whether the use of propofol for anesthesia maintenance in elderly diabetic patients undergoing elective non-cardiac major surgery can reduce the incidence of postoperative delirium. exploratory analysis was conducted to observe the differences in perioperative levels of blood glucose, serum insulin, inflammatory factors (il-6, il-1β, tnf-α), neuroinjury markers (s-100β protein, neuron-specific enolase) between the two groups. this study will provide new perspectives for improving perioperative management in elderly diabetic patients and optimizing anesthesia management strategies to reduce the risk of postoperative delirium.


Eligibility criteria:
inclusion criteria: * age ≥60 years * elective surgery (with an expected duration of 2 hours or more) * asa grade ⅰ-ⅲ * voluntary participation and informed consent obtained * diabetes mellitus exclusion criteria: * known neurological or psychiatric diseases (parkinson's disease, depression, schizophrenia), or cognitive impairment (dementia) * severe visual or auditory impairments, language barriers, or patients who cannot cooperate * long-term use of sedatives, antipsychotic drugs, or long-term alcohol abuse * neurosurgical patients * patients who are expected to require hepatic portal blockage during surgery * patients who are expected to be transferred to icu after surgery * patients with a known allergy to the drugs used in this study or those suspected of having propofol infusion syndrome
a study of rifabutin, used alone or with ethambutol in the prevention of mycobacterium avium complex (mac) bacteremia in patients with aids

Conditions: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Summary: to optimize mycobacterium avium complex (mac) prophylaxis in aids patients by measuring serum rifabutin levels and adjusting the dose accordingly. to combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of mac bacteremia in this patient population.

patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. doses will be adjusted to maintain minimum blood levels of the drugs.

Eligibility criteria:
inclusion criteria concurrent medication: required: * azt, d4t, ddi, or ddc. * antipneumocystis prophylaxis. allowed: * short course (\< 14 days) of ciprofloxacin for acute infections. patients must have: * aids. * cd4 count \<= 100 cells/mm3. * no prior or current mac infection. prior medication: required: * antipneumocystis prophylaxis for at least 4 weeks prior to study entry. allowed: * prior rifabutin. * prior ethambutol. * prior clarithromycin. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * positive tuberculin skin test (ppd \> 5 mm). * active m. tuberculosis. * perceived as unreliable or unavailable for frequent monitoring. concurrent medication: excluded: * other antiretrovirals not specifically allowed. * all investigational drugs. * other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (\>= 14 days). patients with the following prior conditions are excluded: known hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol. prior medication: excluded within 4 weeks prior to study entry: * rifampin. * isoniazid. * clofazimine. * cycloserine. * ethionamide. * amikacin. * ciprofloxacin.

Keywords: rifabutin mycobacterium avium-intracellulare infection drug therapy, combination ethambutol acquired immunodeficiency syndrome
neural mechanisms underlying the antidepressant effects of sleep deprivation

Conditions: Depression, Unipolar

Summary: from 40 to 60% of patients with depression experience a rapid and significant improvement of mood with one night of sleep deprivation (sd). the neural mechanisms underlying this effect have not been elucidated. recent advances in functional neuroimaging have provided new opportunities to investigate state changes in regional brain function, along with a better understanding of the neural networks affected by depression and sd. here we propose to study a group of n=48 antidepressant-free male and female patients with current depression symptom and n=12 healthy controls with no history of mood disorders before and after sd to provide mechanistic insight into the neural substrates underlying the antidepressant effects of sd. we hypothesize that sd-induced concurrent functional activity and connectivity changes in multiple brain networks related to different depressive symptom dimensions including emotion regulation, attention, arousal, self-referential, and reward processing will underlie the rapid and transient antidepressant effects of sd. using an aba design, multimodal brain imaging along with more traditional electroencephalographic (eeg) and neurobehavioral testing data will be acquired at baseline after normal sleep, during one night of total sd, and after one night of recovery sleep using a 5-day in laboratory protocol during which subjects will be continuously monitored by trained staff.


Eligibility criteria:
inclusion criteria: * current depression as assessed on the hdrs-17 (for depressed group only) * body mass index within 15% of normal * stable, normally-timed sleep-wake cycle defined by: a. habitual nocturnal sleep duration between 6h and 9h. b. habitual morning awakening between 0600h and 0800h. * able to comprehend english, as all questionnaires are in this language * ability to provide informed consent exclusion criteria: * shift work, transmeridian travel or irregular sleep/wake routine in past 60 days * a sleep disorder other than insomnia * history of bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders * no history of depression for the control group. * alcohol or drug abuse in the past year * a current smoker. * any acute or chronic, debilitating medical conditions, epilepsy, or thyroid disease. * metallic implants, pacemakers or tattoos, or history of working in metal workshops. * claustrophobic, or intolerant of the scanner environment. * for women, pregnancy will exclude participation.
combination of irreversible electroporation and nk immunotherapy for recurrent liver cancer

Conditions: Recurrent Liver Carcinoma

Summary: the aim of this study is the safety and efficacy of irreversible electroporation (ire) plus natural killer (nk) immunotherapy to recurrent liver cancer.

by enrolling patients with recurrent liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using ire and nk cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 5 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: irreversible electroporation nk immunotherapy recurrent liver carcinoma
study of rn0361in adult healthy subjects and adult hypertriglyceridemic subjects

Conditions: Hypertriglyceridemia; Familial Chylomicronemia Syndrome

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of rn0361 in adult healthy subjects and adult hypertriglyceridemic subjects.


Eligibility criteria:
phase i： inclusion criteria: * willing to provide written informed consent before any study-specific procedures. * comply with the study requirements and restrictions as listed in the informed consent form and the protocol. * fasting serum triglyceride levels \> 80 mg/dl and fasting ldl-c ≥70 mg/dl at screening * female participants must either be nonchildbearing or, if of childbearing potential, not pregnant, not breastfeeding, and using effective contraception. male participants must use condoms and ensure their partners use contraception if they are of childbearing potential. * participants must avoid sperm or egg donation during the study exclusion criteria: * history or presence of any serious or uncontrolled disease * clinically significant health concerns * recent vaccination with live vaccines, except for influenza, or plans to receive such during the study. * positive tests for alcohol or drugs of abuse at screening. * history of multiple drug allergies or allergic reactions to specific components used in the study. phase ii: inclusion criteria: * willing to provide written informed consent before any study-specific procedures. * comply with the study requirements and restrictions as listed in the informed consent form and the protocol. * fasting serum triglyceride levels ≥ 300 mg/dl at screening * female participants must either be nonchildbearing or, if of childbearing potential, not pregnant, not breastfeeding, and using effective contraception. male participants must use condoms and ensure their partners use contraception if they are of childbearing potential. exclusion criteria: * history or presence of any serious or uncontrolled disease * active pancreatitis within 12 weeks prior to day 1 * uncontrolled hypertension (sitting blood pressure) \>160/100 mm hg * uncontrolled diabetes * symptomatic heart failure (nyha ii-iv) * positive serologic test of hbv, hcv, or hiv * alcohol or drugs abuse * history of multiple drug allergies or history of allergic reaction to an oligonucleotide or galnac. * history of intolerance to sc injection or relevant abdominal scarring (surgical, burns, etc) * history of malignancy within the last 2 years prior to the date of consent note: additional inclusion/exclusion ceiteria may apply, per protocol.
use of mri for assessing stomach relaxation in response to a meal

Conditions: Dyspepsia; Healthy Volunteers

Summary: this study is being done to test new way of measuring the relaxation of the stomach after a meal (called gastric accommodation) by using a mri scan. this new test will be compared with the standard test of measuring stomach relaxation that uses radioactive tracers. these tests will be compared in healthy volunteers and people with upper abdominal symptoms (known as dyspepsia).


Eligibility criteria:
inclusion criteria for dyspeptic patients (30 required) * one or more of eight postprandial dyspeptic symptoms i.e. fullness, bloating, epigastric discomfort, early satiety, nausea, vomiting, belching, pain for a minimum of 3 months, or * patients fulfilling the rome-ii criteria for functional dyspepsia, * and no symptom improvement after standard dose ppi treatment, * and normal upper gastrointestinal endoscopy within six months prior to the study inclusion criteria for healthy controls (20 required) • absence of current abdominal symptoms or depression exclusion criteria for all participants * known structural upper gi disorder (e.g. peptic ulcer disease, esophagitis, malignancy); * abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, tubal ligation, or inguinal hernia repair; * medications that may alter gastrointestinal motility, e.g., serotoninergic agents, alpha adrenergic agonists, calcium channel or beta blockers; stable dose of thyroxine will be permitted; * pregnant or breast-feeding females; * known claustrophobia; * any metal objects in the body (e.g. metal implants, pacemaker, aicd)
efficacy of vr distraction during local anesthesia in children

Conditions: Virtual Reality; Anesthesia, Local; Pain

Summary: the aim of this study is to compare between active distraction (video game) and passive distraction (cartoon video) using a virtual reality ( vr ) device, in reducing injection pain and anxiety associated with local anesthesia in children.

this comparative study is a double blinded controlled randomized clinical trial which includes 82 healthy 6-10 years old children with positive and definitely positive behavior according to frankl rating scale with no known allergy to local anesthesia, no emergency dental treatment, no previous treatment from the same researcher and no previous experience in using the virtual reality ( vr ) device. the participants will be allocated and treated at department of pediatric dentistry, faculty of dentistry, tishreen university and a written consent will be obtained from the parents. the random-numbers table will be used to divide 82 participants in to two groups: 1. the active distraction group, which will be receiving the injection of local anesthesia while using the vr device with a video game and a play station 4 ( ps4 ) controller. 2. the passive distraction group, which will be receiving the injection of local anesthesia while using vr device watching a cartoon video. all the participants will receive an inferior alveolar nerve block with semi supine position.

Eligibility criteria:
inclusion criteria: * healthy children need a simple treatment for temporary teeth in the mandibular jaw * children with positive and definitely positive behavior according to frankl behavior classification * children with no known allergy to local anesthesia * children with no previous treatment from the same researcher * children with no previous experience in using the vr device exclusion criteria: * children with negative and definitely negative behavior according to frankl behavior classification * children with known allergy to local anesthesia * children with emergency dental treatment in the mandibular jaw * children with previous treatment from the same researcher

Keywords: virtual reality local anesthesia pain distraction
efficacy and tolerability of clopidogrel resinate and clopidogrel bisulfate in patients with coronary heart disease (chd) or chd equivalents

Conditions: Coronary Heart Disease

Summary: the purpose of this study is to compare the efficacy and tolerability between clopidogrel resinate and clopidogrel bisulfate in patients with coronary heart disease (chd) or chd equivalents.


Eligibility criteria:
inclusion criteria: * korean men and women aged 20 to 85 years with coronary heart disease (chd) or chd equivalent patients * atherosclerotic plaques in coronary computed tomography (ct) or angiography or * history of pci or coronary artery bypass graft surgery (cabg) \> one year or * diabetes mellitus (including type i and type ii) or * confirmed carotid atherosclerotic plaque with sonography, ct or angiography or * history of peripheral artery disease or * history of cerebrovascular disease exclusion criteria: * patients who had history of pci within one year * patients who used concomitant anticoagulants * patients who had hypersensitivity to aspirin or clopidogrel, serious bleeding tendency, history of intracranial hemorrhage, sign of active bleeding, uncontrolled hypertension * chronic alcoholism or drug addiction * women who were pregnant or breastfeeding or who were not using an effective method of contraception * the use of glycoprotein iib/iiia inhibitor, daily nsaids, lipid lowering agent (except atorvastatin), or substances with possible interactions with the study drug

Keywords: chd chd equivalents
use of fitbits during breathing meditation

Conditions: Healthy

Summary: this study will examine short breathing meditations paired with fitbit technology in order to assess mindfulness and track physical activity. measures including heart rate, physical activity, sleep patterns, as well as assessments of well-being and anxiety levels, will be examined.


Eligibility criteria:
inclusion criteria: * older than 18 years. * currently a student, faculty, or staff member at university where research is being completed. * able to wear a fitbit close to 24 hours a day for two weeks. exclusion criteria: * younger than 18 years. * has previously practiced meditation.