Kornimate/medical-research-clean huggingface dataset:
expanded access program of ultratrace iobenguane i131 for malignant relapsed/refractory pheochromocytoma/paraganglioma

Conditions: Pheochromocytoma; Paraganglioma

Summary: the purpose of this sub-study is to provide expanded access of azedra (ultratrace iobenguane i 131) and to evaluate the safety and tolerability of azedra in subjects with iobenguane-avid malignant and/or recurrent pheochromocytoma/paraganglioma (ppgl).

mip-ib12b, the pivotal phase 2 study evaluating efficacy and safety of azedra in patients with malignant relapsed/refractory ppgl, has completed its anticipated enrollment. the purpose of this sub-study, mip-ib12b-eap, is to provide expanded access to azedra for newly enrolled subjects with iobenguane-avid metastatic and/or recurrent ppgl and to collect additional safety data.

Eligibility criteria:
inclusion criteria: * able and willing to provide informed consent/assent and comply with protocol requirements * documented diagnosis of either pheochromocytoma or paraganglioma that was confirmed by histology or other supportive data (e.g. abnormal mibg diagnostic study or elevated tumor markers) * ineligible for curative surgery for ppgl * failed a prior therapy for ppgl or have no alternative indicated therapy available * have definitive tumor avidity confirmed by the azedra dosimetry dose * life expectancy of at least 6 months per physician exclusion criteria: * pregnant or nursing females * men or women of childbearing potential and unwilling to use a medically acceptable form of contraception from time of consent until 6 months following last therapeutic dose of azedra * active cns lesions by ct/mri within 3 months of informed consent * nyha class iv heart failure, unstable angina pectoris or clinically significant cardiac arrhythmia that poses a risk of syncope or cardiac arrest * prior systemic radiotherapy resulting in marrow toxicity within 3 months of first azedra therapeutic dose * prior iobenguane i 131 therapeutic exposure within 12 weeks of the first planned therapeutic dose * prior administration of whole-body radiation therapy within 12 weeks of the first planned therapeutic dose * prior external beam radiotherapy to \> 25% of bone marrow * prior chemotherapy or investigational compound and/or device within 30 days of the dosimetry dose * other active malignancy requiring additional treatment except for superficial cutaneous neoplasms * karnofsky performance status \< 60 * clinically significant laboratory abnormalities prior to dosing as listed in the protocol (such as blood count abnormalities, liver enzyme abnormalities, and renal dysfunction) * medical history of aids/hiv+ * active chronic alcohol abuse, chronic liver disease (not including liver metastases), hepatitis a, b, or c * known allergy to iobenguane that has required medical intervention * receiving a medication which inhibits tumor uptake of iobenguane i 131 * any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject

Keywords: mibg azedra rare neuroendocrine tumors iobenguane i 131 progenics
a safety and tolerability study of abt-089 in adults with attention deficit-hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the objective of this study is to evaluate the long-term safety and tolerability of abt-089 in adults with adhd.


Eligibility criteria:
inclusion criteria: * the subject was randomized into study m06-855 and completed treatment in periods 1 and 2 and the 2-week extension period * if female, subject must be either postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least a method of birth control throughout the study * if female, the result of a pregnancy tests are negative * the subject is judged to be in generally good health exclusion criteria: * more than 7 days have elapsed since the last dose of study drug in study m06-855 * the subject has taken any adhd medication between the last dose of study drug in study m06-855 and the first dose of study drug in the current study * the subject anticipates a move outside the geographic area

Keywords: adhd
effects of acs in twin with lpb: study protocol for a rct

Conditions: Twin Pregnancy, Antepartum Condition or Complication

Summary: this study will be the first study that evaluates the effectiveness of antenatal corticosteroid (acs) in late preterm twin neonates.

antenatal corticosteroid (acs) has been proven to prevent adverse outcomes including respiratory morbidities in preterm neonates before 34 weeks of gestations. recently, it has been suggested that acs may be also effective for reduction of respiratory complications in singleton late preterm pregnancies. on the contrary, there is a paucity of information regarding the effectiveness of acs in twin neonates with late preterm birth, and nowadays guidelines are recommending the use of acs in twin pregnancies based on the evidences in singleton pregnancies. however, the effect of acs in twin needs to be determined, because the rate of neonatal morbidities in twin preterm neonates seems to be different from that in singleton neonates. this study aims to determine the effectiveness of acs in late preterm twin neonates.

Eligibility criteria:
inclusion criteria: * (1) age over 18 years * (2) twin pregnant women at 34weeks 0days to 36weeks 5days of gestation * (3) at risk for preterm birth such as preterm labor, preterm prematrue rupture of membrane or maternal-fetal indications that need preterm delivery. preterm labor is defined as regular uterine contractions with or without the following symptoms; pelvic pressure, backache, increased vaginal discharge, menstrual-like cramps, bleeding/show, cervical changes * (4) availability of written informed consent. exclusion criteria: * (1) gestational age before 34weeks 0days or after 36weeks 6days * (2) lethal major fetal anomaly, fetal distress or fetal death in utero * (3) expected to deliver within 12 hours; for example, advanced cervical dilatation (\>8cm) in preterm labor or active phase labor (cervical dilatation\>4cm) in preterm premature rupture of membranes * (4) history of a previous administration of acs before 34weeks of gestation for fetal lung maturation * (5) administration of systemic steroid for medical indications * (6)diagnosis of clinical chorioamnionitis fever \>37.8 and the presence of two more following conditions: uterine tenderness, foul-odored vaginal discharge, maternal leukocytosis(\>1500), maternal tachycardia(\>100) or fetal tachycardia(\>160)

Keywords: antenatal corticosteroid twin pregnancies respiratory morbidity randomized controlled trial
evaluation of the american thoracic society criteria for predicting multidrug-resistant bacteria in critically ill patients

Conditions: Infection

Summary: appropriate initial antibiotic treatment based on early diagnosis of etiology will improve the outcome of sepsis. the incidence rates of multidrug-resistant (mdr) bacteria, which are different between countries, will affect the accuracy of etiological diagnoses according to the american thoracic society (ats) guidelines. therefore the investigators determined the accuracy of the ats criteria in predicting infection or colonization related to mdr bacteria in china.

all data concerning patient characteristics at icu admission and during icu stay were prospectively collected.screening for mdr bacteria (using nasal swabs, tracheal aspirates from intubated patients and specimens from the infection location) was performed at icu admission and discharge. risk factors for infection or colonization with mdr bacteria were recorded, and the accuracy of the ats criteria in predicting infection or colonization with these bacteria at icu admission was documented. all of the infected patients were treated by the attending physician, and the choice and adjustment of antibiotic were in accordance with the recommendations of the ats guidelines.

Eligibility criteria:
inclusion criteria: * all patients hospitalized in the icu were eligible for this study

Keywords: colonization infection multidrug-resistant bacteria guideline
the role of endometrial blood flow in endometrial cancer

Conditions: Endometrial Cancer

Summary: the incidence of endometrial cancer is gradually increasing nowaday. sonography can be used to evaluate the endometrial volume, the vascularity and the blood flow. this study will analyze the role of preoperative endometrial blood flow in the outcome of endometrial cancer patients.


Eligibility criteria:
inclusion criteria: - \>20 years old female had endometrial cancer exclusion criteria: - \<20 years old female
gut microbiota in obesity and diabetes

Conditions: Obesity; Type 2 Diabetes Mellitus

Summary: an altered gut microbiota composition has recently been linked to obesity and diabetes. the principal aim of this study was to investigate and compare the gut microbiota composition of obese, diabetic and control individuals. then, associations between analyzed gut microbial concentrations and clinical-biochemical blood parameters were assessed.


Eligibility criteria:
inclusion criteria: * subjects with obesity or newly diagnosed type 2 diabetes * 18 years to 65 years of age exclusion criteria: * any chronic disease (other than obesity and diabetes) * alcohol consumption/smoking * pregnancy/breastfeeding * the use of antibiotics, pro-prebiotics within 3 months * \ 65 years * history of intestinal surgery

Keywords: gut microbiota
effect of insulin sensitization on igf-1 response to growth hormone in sga children

Conditions: Small for Gestational Age

Summary: this study is aimed to determine if metformin treatment in children born small for gestational age (sga) who are being treated with growth hormone (gh) for short stature improves the response to gh by producing greater concentrations of insulin-like growth factor -1 (igf-1) in the blood.

growth hormone treatment (gh) is recommended in children born small for gestational age (sga) who fail to catch-up. sga is a heterogeneous condition as reflected in the varied response to gh treatment. variable generation and resistance to insulin-like growth factor-1 (igf-1), the most important circulating mediator of gh action may underpin this heterogeneity. an association between the variants in the genes related to lower insulin sensitivity and reduced igf-1 and growth response to gh therapy in sga children have been reported recently. the hypothesis of this study is that insulin sensitivity may be causally linked to the response to gh therapy, and adjuvant therapy with an insulin sensitizer may improve igf-1 generation, decrease igf-i resistance and optimise growth response. to explore this hypothesis, this study aims to determine the effects of insulin sensitization using metformin as an adjuvant to a fixed dose gh therapy for 6 months in short sga children. the patients will be short sga children between age 4 -10 years and identified from three paediatric endocrine units in denmark, ireland and the united kingdom. in this mechanistic study 24 subjects starting gh treatment will be randomised in a 1:1 ratio to adjunctive metformin or placebo for 6 months and followed-up for another 6months. the participants will receive gh treatment for the entire duration of the study (12 months) and will undergo an oral glucose tolerance test and dual-energy x-ray absorptiometry scan to determine glucose metabolism and body fat mass respectively at baseline and 6 months, and will have 3 monthly measurements of height, weight and skinfold thickness. the primary outcome will be the area under the curve of igf-1 levels measured at 0, 1, 3 and 6 months. secondary outcomes will include changes in insulin sensitivity, height, body fat mass and safety measures at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * sga children eligible for gh treatment according to european medicines agency (ema) and the national institute for health and care excellence (nice) criteria * gestational age at birth \>28 weeks * age 4-9 years in girls and 4-10 years in boys * prepubertal at start of treatment * naïve to gh therapy exclusion criteria: * known or suspected allergy to gh * previous participation in a gh trial * severe learning difficulties * previous or active malignancy * benign intracranial hypertension

Keywords: small for gestational age insulin sensitivity igf-1 response growth hormone treatment
adipose tissue function and response to exercise training in women with and without polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the primary aim of this trial is to investigate adipose tissue function in women with and without polycystic ovary syndrome (pcos). pcos is a common endocrine disorder in young women. the pathogenesis behind pcos is complex and only partly understood, and deeper mechanistic insight is needed. insulin resistance is a central feature of pcos, and recent studies have suggested that this is linked to aberrant adipose tissue function. exercise training has been found to improve the symptoms in pcos, but we need more knowledge about why. while processes involved in skeletal muscle oxidative remodeling are well described, it is to a large extent unknown whether the oxidative capacity of human adipose tissue is modified by endurance training. the women included in this study will be matched (for body mass index, body weight, and age) to participants in another study. this will enable the investigators to do a comparison between cases (women with pcos) and controls (women without pcos) at baseline, and to assess the responses to exercise training in adipose tissue.


Eligibility criteria:
inclusion criteria: * eumenorrheic * matching pcoc group in improv-it study (nct02419482) * living nearby st olavs hospital, trondheim, norway exclusion criteria: * signs of hyperandrogenism * regular high intensity endurance (two or more times per week of vigorous exercise). * concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion). * on-going pregnancy * hormonal contraception * breastfeeding within 24 weeks

Keywords: exercise therapy adipose tissue mitochondria oxidative phosphorylation
post-treatment ultrasensitive positron emission tomography in nasopharyngeal carcinoma patients

Conditions: Nasopharyngeal Carcinoma

Summary: npc patients receiving imrt treatment will receive a dedicated fdg pet/ct and high-sensitivity pet/ct protocol simultaneously in the follow-up of locally advanced nasopharyngeal carcinoma. hence we establish this prospective cohort study.

newly-diagnosed patients with stage iii or iv non-metastatic nasopharyngeal carcinoma (ajcc 8th) will be recruited. all subjects receiving chemoradiotherapy will undergo a baseline integrated \[18f\]fluoro-2-deoxy-d-glucose (fdg) positron emission tomography/computed tomography (pet/ct) scan or traditional follow-up examination before the start of chemoradiotherapy. npc patients receiving imrt treatment will receive a dedicated fdg pet/ct and high-sensitivity pet/ct protocol simultaneously 12 weeks after the end of chemoradiotherapy (primary endpoint). the results of fdg pet/ct and high-sensitivity pet/ct analyzed and compared.

Eligibility criteria:
inclusion criteria: * patients must be informed of the investigational nature of this study and given written informed consent. * aged between 18-70, male/female. * staged iii or iv (ajcc 8th) npc patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, who ii and iii). * received induction chemotherapy and/or concurrent chemoradiotherapy. ecog scale 0-1. * fertile women should practice contraception during the study period. * hgb ≥90g/l ,wbc ≥4\*109/l , plt ≥100\*109/l, * with normal liver function test (alt and ast ≤2.5\*uln, tbil ≤2.0\*uln) * with normal renal function test (serum creatinine ≤1.5\*uln) exclusion criteria: * women in pregnancy or lactation * prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ. * any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×uln), and emotional disturbance. * already involved in other clinical trial. * mental disorder, civil disability, limited capacity for civil conduct.

Keywords: high-sensitivity pet ct pet ct
a trial of shr-1703 in healthy subjects

Conditions: Asthma

Summary: this is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. the objective of this study is to evaluate the safety, tolerability, pharmacokinetics pharmacodynamics and immunogenicity of subcutaneous administered shr-1703 in healthy subjects.

the study will consist of one dose esclation part with a total of 3 dose levels. the subjects will be randomized to receive shr-1703 as reflected by the guiding principle for the dose esclation/expansion phase. each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

Eligibility criteria:
inclusion criteria: 1. healthy caucasian subjects, male and female, 18 to 55 years of age, inclusive; 2. body weight ≥45 kg (both male and female), body mass index (bmi) between ≥19.0 and ≤29.9 kg/m2, inclusive; 3. no clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry and coagulation function) and ecg at the investigator's discretion during screening and baseline. 4. men and women of childbearing potential (wocbp) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 30-days after last scheduled follow-up visit. exclusion criteria: 1. known history or suspected of being allergic to the study drug. 2. positive hepatitis b virus (hbsag), hepatitis c virus (hcv-ab), human immunodeficiency virus (hiv-ab) at screening. 3. participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer 4. use of any medicine within 4-weeks prior to the ip administration 5. blood donation or loss of more than 400 ml of blood within 1 month of screening; or received blood transfusion within 2 months before screening. 6. live (attenuated) vaccination within 1 month before screening or plan to be vaccinated 7. severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial 8. patients with known or suspected parasitic infection within 6 months before screening 9. either alt, ast, alp, ggt or total bilirubin level exceeds upper limit of normal range (uln) at screening or baseline visits (confirmed by a single repeat, as per investigator's judgment) 10. more than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening. 11. history of alcohol abuse within 3 months prior to the ip administration
study of prevalence and risk factors of hypovitaminosis c in long term care unit

Conditions: Vitamin C Deficiency; Scurvy

Summary: the clinical finding of skin rashes which appear after a vitamin c deficiency in long term care unit leads us to believe that the institutional diet could predispose to this kind of deficiency. vitamin c has a key role into the struggle against oxidant stress and is involved into the connective tissue formation of the skin and the vascular endothelium. vitamin c deficiency affects currently 15 to 25% of the elderly over 65 years old reaching 15% women and 20% men after 65 according to johnston and al. it concerns mainly the people in precarious situations (persons without fixed homes, ethyl-smoking persons) and elderly over 65 years. hypovitaminosis c, defined by plasma level between 5 mg/l and 15 mg/l (28.41 to 85.23 µmol/l), is currently undiagnosed, especially with people with a risk of food deficiency and its prevalence increases with age. the treatment consists of a daily oral supplementation of 1 gram of vitamin c/d for 15 days. a minimum intake of 10 mg/d of vitamin c is required to prevent scurvy and maintain a total pool of 350 mg. a diet modification by a systematic intake of 2 glasses of fresh orange juice and/or the consumption of raw fruits and vegetables would prevent the appearance of scurvy.


Eligibility criteria:
inclusion criteria: * male or female over 65 years old * living in the unit of long term care without any limit time. * with a system of social insurance * who gave its consent by his own , or with help of his representant or his tutor or curator. exclusion criteria: * rejection of the blood sample * patient feeding with articial nutritional feeding (stomach tube feeding) * person close to death, who is not able to feed himself and / or with life-threatening in short time. * patient with personal history of vitamin c deficiency.

Keywords: vitamine c deficiency skin rash scurvy food texture geriatric institution unit of long term care
effects of a 12-week combined exercise program on ghrelins in obese adolescent girls

Conditions: Ghrelin

Summary: this study aimed to explore the effects of a 12-week combined exercise on ghrelin o acyl transferase, acylated ghrelin and desacylated ghrelin levels in obese girls.

little is known about on ghrelin o acyl transferase (goat), acylated ghrelin (ag) and desacylated ghrelin (dag) levels during long-term exercise in adolescent population. our previous study showed that combined exercise program in overweight children increases dag with unchanged ag. this study aimed to explore the effects of a 12-week combined exercise on goat, ag, and dag in obese girls.

Eligibility criteria:
inclusion criteria: * girls between 16 and 18 years * being classified as being overweight or obese defined with the 85th percentile of body mass index or above based on the 2007 growth chart for korean children aged 2-18 years. * after consultation with a physician, they were required to be considered physically healthy enough to engage in regular exercise after school. exclusion criteria: * participation in any weight-management programme in the past 6 months * engagement in other exercise programs except for regular physical education at school * smoking * amenorrhea for consecutive 2 months or more * being treated for hereditary diseases, mental disorder, hypertension, diabetes mellitus, or musculoskeletal impairments * taking any medication or supplements for weight control