Kornimate/medical-research-clean huggingface dataset:
risk prediction in type ii diabetics with ischemic heart disease

Conditions: Type-2 Diabetes Mellitus; Ischemic Heart Disease

Summary: the purpose of this study is to test whether cardiac autonomic dysfunction predicts is a prognostic marker in type-2 diabetics with ischemic heart disease

in patients with type 2-diabetes and ischemic heart disease autonomic function might be seriously affected. in the present study, markers of cardiac autonomic dysfunction, repolarization and respiration abnormalities will be assessed from holter recordings and 30-minute recordings of high-resolution three dimensional ecg, non-invasive arterial blood pressure and respiratory activity. the correlation between markers of cardiac autonomic dysfunction and markers of severity of type-2 diabetes will be assessed. autonomic dysfunction is assumed present when both heart rate turbulence and deceleration capacity are abnormal ("severe autonomic failure"). assessment of severity of diabetes includes levels of hba1c and urine albumine, duration and treatment of diabetes, and diabetes related complications (nephropathy, neuropathy, retinopathy).

Eligibility criteria:
inclusion criteria: * type-2 diabetes * coronary artery disease exclusion criteria: * age \>80 years * acute coronary syndrome * life expectancy \<1 year * unable to give informed consent

Keywords: diabetes coronary artery disease ischemic heart disease autonomic function heart rate turbulence deceleration capacity severe autonomic failure
the feasibility and safety of head-up cardiopulmonary resuscitation in patients with non-traumatic cardiac arrest

Conditions: Cardiac Arrest

Summary: head up cpr with impedance threshold device(itd) and active compression-decompression (acd) has been proved to improve both cerebral and coronary perfusion pressure during resuscitation in animal models. increased rates of spontaneous circulation (rosc) were also observed in cardiac arrest patients. the goal of this clinical trial is to learn about the feasibility and safety of head-up cardiopulmonary resuscitation in patients with non-traumatic cardiac arrest. participants will be received head-up cpr during resuscitation. the main question it aims to answer is if there is any adverse or unfavorable event during resuscitation.


Eligibility criteria:
inclusion criteria: * non-traumatic cardiac arrest * age ≥ 20 exclusion criteria: * trauma * age \< 20 * pregnancy * irreversible death (e.g. liver mortis, rigor mortis, decapitation, transection and decomposition) * disorder of cervical spine

Keywords: cardiac arrest head-up cardiopulmonary resuscitation
benefit of changing chemoradiotherapy sequence and modifying radiotherapy schedule for advanced nasopharyngeal cancer

Conditions: Nasopharyngeal Neoplasms

Summary: the objectives of this clinical study are threefold: 1. to compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation. 2. to test whether replacing fluorouracil with xeloda in combining with cisplatin (pf or px, respectively) in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay. 3. to see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.


Eligibility criteria:
inclusion criteria: * histologically proven nasopharyngeal carcinoma * non-keratinizing or undifferentiated type stage iii-ivb (by ajcc/uicc 6th edition) * essential staging investigations: ct or mri of nasopharyngeal region chest x-ray (or ct thorax) * liver function test, alkaline phosphatase liver and bone scan if alkaline phosphatase exceeds the institutional upper limit of normal, or if clinically indicated. * liver scan if sgot exceeds the institutional upper limit of normal * adequate marrow: wbc \> 4 and platelet \> 100 * adequate renal function: creatinine clearance \> 60 ml/min. * satisfactory performance status: \> 2 by ecog system. exclusion criteria: * who type i squamous cell carcinoma or adenocarcinoma * age \> 70 * treatment with palliative intent (including those with tumor extent mandating the use of ap opposing facio-cervical field technique) * prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which the patient has been disease-free for five years. * pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). * history of previous rt (except for non-melanomatous skin cancers outside intended rt treatment volume). * prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

Keywords: nasopharyngeal carcinoma stage iii - ivb
study of 64cu-fapi-xt117 pet/ct in patients with malignant solid tumors

Conditions: Malignant Solid Tumors

Summary: this is the study of 64cu-fapi-xt117, which is an prospective, single-arm phase i clinical study.


Eligibility criteria:
inclusion criteria: * 1. signed the informed consent * 2. ≥18 years old * 3. confirmed as malignant solid tumor by histopathology or clinical judgment * 4. patients will undergo 18f-fdg pet/ct examination exclusion criteria: * 1. known allergy to components of the investigational drug or its analogues * 2. suspected to have a certain disease or condition that is not suitable for the study drug * 3. known pregnant or lactating women
non-operative management of rectal cancer patients

Conditions: Rectal Cancer; Chemoradiotherapy; Watch & Wait

Summary: this study is a single-center, open, prospective, single-treatment trial (pilot study). this study aims to analyze the treatment results after receiving capecitabine adjuvant chemotherapy for 4 months after non-surgical treatment in patients who had completed and could have clinical complete remission with capecitabine preoperative chemoradiotherapy with capecitabine for mid-to-lower rectal cancer and to investigate the feasibility of non-surgical treatment.

indication: 1. mid-to-lower rectal cancer was diagnosed histologically as adenocarcinoma in preoperative examination, 2. the tumor was located at the lower boundary of the tumor spans the anorectal junction, and the clinical stage is stage 2 or 3, and 3. clinical complete remission was confirmed after the treatment response evaluation at 8 weeks after completion of preoperative chemoradiotherapy according to mr/sfs and biopsy. aim: 1. to analyze the treatment results after receiving capecitabine adjuvant chemotherapy for 4 months after non-surgical treatment in patients who had completed and could have clinical complete remission with capecitabine preoperative chemoradiotherapy with capecitabine for mid-to-lower rectal cancer 2. to investigate the feasibility of non-surgical treatment.

Eligibility criteria:
inclusion criteria: * clinical cr after pre-operative crt for rectal cancer exclusion criteria: -

Keywords: rectal cancer chemoradiotherapy watch & wait capecitabine
hrt versus mos for endometrial preparation prior to fet in non pcos patients

Conditions: Infertility

Summary: evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation prior to frozen-thawed embryo transfer (fet) in patients without polycystic ovarian syndrome (pcos)

women will be randomly divided into two groups; one will be subjected to endometrial preparation by hormone replacement therapy (hrt) and the other will be subjected to minimal ovarian stimulation (mos). women in the hrt group will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (tvs). if the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is \ 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours. in both groups, fet will be planned in the appropriate day according to the stage that the embryos have been cryopreserved in it.

Eligibility criteria:
inclusion criteria: * women without pcos as defined by the rotterdam criteria. * presence of at least 2 cryopreserved good quality cleavage-stage embryo (good quality cleavage-stage embryos display stage-specific cell division, have blastomeres of fairly equal size with few to no cytoplasmic fragments). exclusion criteria: * pcos or polycystic ovary on ultrasound scan. * moderate or severe endometriosis. * hydrosalpinx. * uterine abnormalities or myoma. * previous uterine surgery.

Keywords: frozen-thawed embryo transfer fet protocols
trial to assess lacosamide as the first add-on anti-epileptic drug treatment in patients with partial-onset seizures

Conditions: Partial Epilepsies

Summary: to evaluate the efficacy and safety of oral lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy antiepileptic drug (aed) regimen compared to subjects who have received treatment with at least 2 aeds.

the study consisted of 3 periods: period 1: a 1-week screening phase, period 2: a 30-week treatment phase (consisting of a 6-week titration phase and a 24-week maintenance phase), and period 3: a 3-week taper/safety follow-up phase.

Eligibility criteria:
inclusion criteria: group 1: * subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization * currently taking adequate monotherapy (defined as a single antiepileptic drug (aed) for at least 28 days prior to screening) and has no history of aed polytherapy. prior use of rescue medication (short-term intermittent use) is acceptable * epilepsy diagnosis should be ≤24 months at the time of the screening visit * the minimum allowed seizure frequency at any time during the 12 weeks prior to the screening visit is ≥3 partial-onset seizures group 2: * subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization * currently taking 1 to 3 aeds, and has tried at least 2 prior aed treatment regimens (concurrently or sequentially) * epilepsy diagnosis should be ≥5 years at the time of the screening visit * the minimum allowed seizure frequency during the 12 weeks prior to the screening visit is ≥1 partial-onset seizure per 28 days exclusion criteria: * previous use of lacosamide * history of seizure disorder characterized primarily by isolated auras * history of primary generalized seizures * history of status epilepticus within last 12-months * history of cluster seizures during the 12 week period prior to visit 1 * nonepileptic events, including pseudoseizures that could be confused with seizure * lifetime history of suicide attempt or suicidal ideation in the past 6 months * hypersensitivity to any component of lacosamide * history of drug or alcohol abuse * history of an acute or subacutely progressive central nervous system (cns) disease * undergone cranial surgery within the last year prior to study entry * concomitant treatment of felbamate or previous felbamate therapy within the last 6 months * prior or concomitant vigabatrin use

Keywords: epilepsy treatment anti-epileptic drugs seizures vimpat
efficacy and safety of xrp0038/nv1fgf in critical limb ischemia patients with skin lesions

Conditions: Peripheral Vascular Diseases

Summary: primary objective is to demonstrate the superiority of riferminogene pecaplasmid (xrp0038/nv1fgf) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (cli) patients with skin lesions. secondary objectives are to evaluate: * the efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation; * the efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death; * the safety of riferminogene pecaplasmid in the study population.

the study consists in 6-week treatment then a follow-up period up to 12 months. a follow-up contact is then scheduled 6 months later. per protocol amendment a 18-month long-term safety survey was added.

Eligibility criteria:
inclusion criteria: * having peripheral artery disease at the stage of critical limb ischemia (cli) with skin lesions (either ulcer(s) or gangrene); * with objective evidence of cli such as ankle systolic pressure \<70 mmhg and/or toe systolic pressure \<50 mmhg or transcutaneous oxygen pressure (tcpo2) \<30 mmhg; * unsuitable for standard revascularization of his/her peripheral arterial disease; * having a negative screening for cancer. exclusion criteria: * previous major amputation on the leg to be treated or planned major amputation within the first month following randomization; * known buerger's disease; * successful lower extremity revascularization procedure within 3 months prior randomization; * uncontrolled blood pressure defined as systolic blood pressure (sbp) ≥180 mmhg or diastolic blood pressure (dbp) ≥110 mmhg despite adequate antihypertensive treatment; * acute cardiovascular events within 3 months prior to randomization; * active proliferative retinopathy and severe macular oedema; * previous or current history of malignant disease within the past 5 years; * previous treatment with systemic angiogenic factors or with stem cells therapy; * pregnant or breast-feeding woman or woman of childbearing potential not protected by an effective contraceptive method of birth control. man not following effective contraceptive method with his partner of childbearing potential during the course of the study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: critical limb ischemia peripheral artery disease plasmid based gene therapy
correlation between vitamin d and symptoms severity of autonomic nervous mediated syncope child and it 's raas

Conditions: Vitamin D

Summary: children ; autonomic nervous mediated syncope； vitamin d ; symptom score ; renin-angiotensin-aldosterone-system

children with autonomic nervous mediated syncope have seriously affects children's physical and mental health and quality of life, and the incidence rate is also increasing year by year. but the current treatment measures are not ideal, therefore, we need to look for new biological indicators, according to different biological indicators to develop different treatment options, so as to improve the current situation of poor treatment of children with nms

Eligibility criteria:
inclusion criteria: * children diagnosed with oi; * compliance with the diagnostic guidelines for syncope in children (2016 edition) and 2018 syncope in children and adolescents in the cardiovascular group of the society of pediatrics, chinese medical association the diagnostic criteria of oi in the diagnostic and therapeutic guidelines. exclusion criteria: * taken 3 months prior to admission vitamin d or hormone drugs; * heart, brain, nerves, metabolism, blood and other apparatus syncope or aura of syncope caused by a qualitative disease;

Keywords: children ; vvs； vitamin d ; symptom score ; raas
micronutrients and child health study

Conditions: Malaria

Summary: the purpose of this study is to determine to what extent supplementation with zinc and other micronutrients are efficacious in preventing malaria in young tanzanian children.

zinc is essential for the functioning of the immune system. supplementation trials in asia, latin america, the pacific and developed countries have shown that increasing zinc intake has great potential to control common infections in children, but the response to supplementation may be different in africa, where the primary environmental challenge to children's health is malaria. simultaneous supplementation with other potentially limiting nutrients may be required to overcome a lack of response when zinc is given alone. the project aims at measuring effects of daily oral supplementation with zinc and other micronutrients, given either alone or in combination, on malaria incidence and nutritional status, and on indicators of immunity.

Eligibility criteria:
inclusion criteria: * aged 6-60 months * permanently residing in the study area * being moderately or mildly stunted (height-for-age z-score \<-1.5 sd) * informed consent from parents or guardians obtained exclusion criteria: * severe wasting (weight-for-height z-score \<-3 sd) * hemoglobin concentration \<70 g/l * axillary temperature ≥37.50 °c with malaria antigenemia * signs and symptoms at randomisation suggesting malaria, hepatitis, hiv/aids, tuberculosis, sickle cell disease or other severe condition * unable to produce a venous blood sample (\>1 ml)

Keywords: micronutrients zinc vitamins trace elements minerals vitamin a vitamin b1 vitamin b2 niacin vitamin b6 folic acid vitamin b12 vitamin c vitamin d vitamin e vitamin k iron iodine copper selenium magnesium calcium malaria immunity anthropometry
diagnostic study of temporal arteritis

Conditions: Temporal Arteritis

Summary: despite a large and growing body of knowledge concerning the diagnosis of temporal arteritis, this potentially crippling disease still requires pathological diagnosis in practically every case. it seems likely that a correctly estimated clinical probability could help in evaluating imaging results in a way that might safely obviate temporal biopsy in a large segment of suspect cases. with this aim in view, we intend to identify useful clinical items and integrate them in an appropriate diagnostic pathway.


Eligibility criteria:
inclusion criteria: * patients suspected of temporal arteritis and referred by their physicians to biopsy of a temporal artery. exclusion criteria: * pregnancy; age \> 80 or \< 18; unable to answer study questions
a comparison of the immunogenicity and safety of quinvaxem in mono-dose vials and uniject

Conditions: Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Infections

Summary: this is a study to show that vaccination with three doses of quinvaxem presented in uniject is not inferior to vaccination with three doses of quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis b surface antibodies, anti-polyribosyl ribitol phosphate (prp), anti-diphtheria, anti-tetanus and anti-bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.


Eligibility criteria:
inclusion criteria: * a male or female between, and including, 42 and 64 days of age at the time of the first vaccination * written informed consent obtained from parents/legal guardians of the subject * free of obvious health problems as established by medical history and/or clinical examination before entering the study * hepb vaccination at birth (within 48 hours) * available for all scheduled study visits exclusion criteria: * use of any investigational drug or any investigational vaccine in the 30 days preceding the first dose of study vaccine, or their planned use during the study period and safety follow-up * planned administration of a vaccine not foreseen by the study protocol * known or suspected impairment of immune function, known hiv-positivity; actively receiving immunosuppressive therapy, or in receipt of systemic immunosuppressive therapy in the one month prior to study entry (note: inhaled and topical steroids are allowed) * administration of parenteral immunoglobulin preparation and/or blood products since birth * previous vaccination against hib and/or dtp * history of anaphylaxis, or any serious vaccine reaction, or hypersensitivity to any vaccine component or to products containing mercury compounds, such as thiomersal * clinically significant acute infection * clinically significant acute illness * any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives * participation in another clinical study

Keywords: vaccination immunisation virus diphtheria pertussis tetanus hepatitis b haemophilus influenzae immunity
maximal leg press strength training study for coronary artery disease patients

Conditions: Heart Failure; Coronary Artery Disease

Summary: maximal strength training has been shown to increase muscular strength, muscular volume and work economy. an 8 week maximal leg press training regime will be conducted on cardiac heart failure patients to evaluate whether they increase their maximal leg press strength, work economy, serum testosterone and quality of life. the study hypotheses are that: 1. aerobic work capacity will increase due to increased work economy, without increases in maximal oxygen uptake. 2. strength training will increase serum testosterone.


Eligibility criteria:
inclusion criteria: * clinically diagnosed coronary artery disease * stable coronary artery disease * 1.5 mm depression in st segment during a cycling strain test * between 18-70 years of age exclusion criteria: * unstable coronary artery disease * other limitations to exercise than coronary artery disease * participants in other study interventions

Keywords: cardiac heart failure leg press maximal strength training serum testosterone work economy
efficacy and safety of tofacitinib in chinese subjects with active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: this is a 6 month study investigating the effectiveness and safety of tofacitinib in treating signs and symptoms and improving physical function in chinese patients with active psoriatic arthritis and had inadequate response to a conventional synthetic disease modifying anti-rheumatic drug. this is a china alone study.


Eligibility criteria:
inclusion criteria: * chinese patients * active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints * active plaque psoriasis at screening * inadequate response to at least one conventional synthetic dmard exclusion criteria: * non-plaque forms of psoriasis (with exception of nail psoriasis) * history of autoimmune rheumatic disease other than psa; also prior history of or current, rheumatic inflammatory disease other than psa

Keywords: psoriatic arthritis tofacitinib china
expression of tim-3 and correlation with disease activity in pediatric crohn's disease with anti tnf-α therapy

Conditions: Crohn's Disease

Summary: this study investigated the expression of t-cell immunoglobulin- and mucin-domain-containing molecule 3 (tim-3) in the colonic mucosa and/or the peripheral blood of children with crohn's disease during anti tnf-α (infliximab) therapy.

the immunoregulatory effects of tim-3 on patients with crohn's disease according to the treatment have not yet been investigated.

Eligibility criteria:
inclusion criteria: * •pediatric patients who were diagnosed with severe crohn's disease who require infliximab treatment * confirmed diagnostic of crohn's disease in clinical, endoscopic and histological findings exclusion criteria: * •patients who has proven to have infliximab antibody

Keywords: crohn's disease infliximab t-cell immunoglobulin- and mucin-domain-containing molecule 3 (tim-3)