Kornimate/medical-research-clean huggingface dataset:
a registry study on biomarkers of takayasu's arteritis (arsbta)

Conditions: Takayasu's Arteritis

Summary: takayasu arteritis is a chronic vasculitis mainly involving the aorta and its main branches such as the brachiocephalic, carotid, subclavian, vertebral, and renal arteries, as well as the coronary and pulmonary arteries. inflammation causes segments of the vessels to become narrowed, blocked, or even stretched, possibly resulting in aneurysms. the disease is very rare but most commonly occurs in young asian women. however, there is a considerable lack of understanding of the disease mechanism of takayasu arteritis. initially, the disease remains clinically silent (or remains undetected) until the patients present with vascular occlusion. additionally, many individuals with takayasu arteritis, however, have no apparent symptoms despite disease activity. therefore, biomarkers for diagnosis and monitor disease activity in individuals with takayasu arteritis are needed. in this study, the investigators therefore to use different methods to identify new biomarkers for diagnosing or monitoring the disease activity in individuals with takayasu arteritis. these biomarkers may provide valuable insights into the underlying biochemical processes and aid the understanding of the pathophysiology of this disease.


Eligibility criteria:
retrospective inclusion criteria: subjects who met the american college of rheumatology 1990 classification criteria for takayasu arteritis: 1. age of onset ≤40 years, 2. claudication of upper or lower extremities, 3. decreased pulsation of 1 or both brachial arteries, 4. difference of ≥ 10 mmhg in systolic blood pressure between arms, 5. bruit over subclavian arteries or aorta, 6. \*arteriographic evidence showing a branch of the aorta stenosis or occlusion. meeting more than 3 of 6 criteria suggests the diagnosis of takayasu arteritis. \*angiography in this study was replaced by vascular magnetic resonance angiography(mra)or computed tomography angiography(cta). exclusion criteria: 1. arteriographic lesions that could be entirely due to atherosclerosis, 2. suffer from other autoimmune diseases (eg, anca-associated vasculitis, systemic lupus erythematosus, etc.) besides takayasu arteritis, 3. cogan's syndrome, 4. behcet's disease, 5. subjects with any serious acute or chronic infection, 6. giant cell arteritis (large vessel vasculitis and at least 50 years old) or other infectious forms of large vessel vasculitis. prospective inclusion criteria: subjects with initial suspicion of having takayasu arteritis or patients with takayasu arteritis need assessment of disease activity were prospectively enrolled. exclusion criteria: 1. patients without image studies. 2. patients with confirmed other autoimmune diseases (eg, anca-associated vasculitis, systemic lupus erythematosus, etc.)

Keywords: biomarkers
functional imaging in hnc undergoing chemoradiation

Conditions: Head and Neck Cancer

Summary: the purpose of the study is to generate a library of functional imaging and anatomical imaging for patients with head and neck cancers for evaluation of new radiotherapy strategies and planning techniques including imrt. secondary aims would be to observe the changes in the cancers as the treatment progresses as well as to define the biologically most active part of the tumor (biological target volume) which could be given more intensive treatment. tumor volumes seen on different imaging modalities will be compared with a hope of finding an optimal imaging methodology for accurate visualization of the head and neck cancers

adult patients who have a head and neck cancer and are planned to receive chemotherapy and radiotherapy will be invited to participate in the study. patients who are not in very good health, have diabetes or kidney failure will not be considered for the study. also patients who can not undergo mri scan or are allergic to contrast injection given prior to the scan or have had any other form of cancer (except skin cancer) will also be excluded from the study.

Eligibility criteria:
inclusion criteria: * patients with histologically proven head and neck cancer, planed for chemotherapy and radiotherapy * age more than 18 years * patient willing to participate and has signed a consent form * patients in good physical status (who performance status 0-2) exclusion criteria: * patients in poor health (who performance status \>2) * patients with any other cancer apart from skin cancer * patients with contraindications to mri scan and iv contrast * diabetic patients * patients with renal failure

Keywords: head and neck cancer dw mri pet dce mri functional imaging imrt
markers of pubertal suppression during therapy for precocious puberty

Conditions: Central Precocious Puberty

Summary: the best way to measure whether treatment of children with central precocious puberty is working is to do a hormone stimulation test (leuprolide stimulation test) that requires injection of a medication and multiple blood draws to see if the hormonal response is suppressed (blocked). the hypothesis of this study is that random measurement of the free alpha subunit of pituitary glycoprotein, a protein related to the pituitary hormones that stimulate puberty, will provide an adequate alternative to the leuprolide stimulation testfor monitoring efficacy of pubertal suppression with supprelin la®.

during clinical trials of supprelin la®, leuprolide stimulation tests were performed to determine adequacy of suppression. however, the use of this stimulation test to monitor suppression requires an expensive medication and collection of multiple blood samples. alternative methods of monitoring pubertal suppression during gonadotropin releasing hormone receptor agonist (gnrha) therapy have included both random and trough levels of luteinizing hormone (lh), estradiol or inhibin b. recently, the free alpha subunit of pituitary glycoprotein (faspg) has also been shown to be a potentially useful marker of hormonal suppression (hirsch hj, et al, jcem 95:2841, 2010) as it undergoes a paradoxical rise following initiation of therapy, and reverts to baseline upon completion. in this investigator-initiated pilot study we will evaluate novel markers of pubertal suppression in children receiving standard of care gonadotropin releasing hormone receptor agonist therapy for the treatment of central precocious puberty. children with central precocious puberty who have selected treatment with supprelin la will undergo hormonal testing of markers of pubertal activity before and after placement of the supprelin la insert.

Eligibility criteria:
inclusion criteria: * female * age: 3 to 9 years old, inclusive * diagnosis of central precocious or rapidly progressive puberty * bone age more than 1 year advanced (obtained within 6 months of screening) and * breasts tanner ii or greater and * one of the following: * random lh \> 1 miu/ml * leuprolide-stimulated lh \> 4 miu/ml * random estradiol \> 20 pg/ml * leuprolide-stimulated 24 hour estradiol \>20 pg/ml * naïve to gnrha therapy * approved to receive supprelin la® therapy * have an acceptable surrogate capable of giving consent on the subject's behalf. exclusion criteria: * previous gnrha therapy * presence of peripheral precocious puberty including cah

Keywords: central precocious puberty suppression alpha subunit leuprolide stimulation test
development of a new electronic measure of pediatric pain: a pilot study

Conditions: Pediatric Pain

Summary: the purpose of this study is to test the accuracy of a computer-based program to self-report the location and intensity of a child's pain in comparison to a traditional self-report paper and pencil measure and physician physical exam. using a computer to assess pediatric pain may offer many advantages and improvements in how pediatric pain is diagnosed and treated.

approximately 1 in 4 children aged 5-18 report experiencing pain. as many as 2 in 3 of these children will develop a significant physical, emotional, social or academic impairment. recent research has identified pediatric pain as an area where biological, psychological and social treatments can interact to provide substantial changes in pain symptoms. however, there is a lamentable dearth of empirical studies evaluating the efficacy of treatments for chronic pain in children. these findings necessitate more intensive efforts to improve methods on initial assessment and treatment, but an important first step is to improve the sensitivity of outcome evaluation. existing measures of pediatric pain have been concerned with symptom intensity and the general locus of pain. children are traditionally asked to mark with a number or a color the region in which they experience pain. this is helpful for understanding generality that a large area such as the head, joints, or stomach hurts. however, it does not allow the child the option to specify a narrow area of discomfort within a broader region (e.g., upper right quadrant of the stomach). consequently, current pain instruments may lead to an inaccurate or imprecise understanding of a child's pain, which can adversely impact clinical care of the quality of clinical trials. the current study will compare a widely used paper-based "pain mapping" tool to a new electronic tool designed by study investigators to capture the same information as the paper measure, while adding more precision regarding pain regions and greater range in terms of pain intensity. we expect that children's responses on these two measures (pencil/paper and electronic) will be generally similar, but we expect that the electronic measure will map more closely onto the attending physician's notes regarding discrete pain location, intensity, and/or diagnosis.

Eligibility criteria:
inclusion criteria: * presentation to either apc clinic or ipm clinic. * child participant is 8-17 years of age. exclusion criteria: * child/parent not english speaking. * child unable to see computer screen or interact with the keyboard or mouse. * parent/child unable or unwilling to provide permission/assent.

Keywords: electronic diary body map electronic measure of pediatric pain
non inferiority trial investigating surfactants administered via mist

Conditions: Respiratory Distress Syndrome

Summary: research design multicenter, randomized, controlled trial. recruitment entry criteria preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome. infants who are on ncpap and fio2 ≥0.30 will randomized to curosurf or infasurf via mist. exclusion criteria infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress. babies who require emergent intubation will not be enrolled in the interventions. parental consent will be obtained prior to randomization.

intervention infants who on cpap who reach the threshold of 30% oxygen will be randomized to calfactant (infasurf), 3ml/kg or poractant alfa (curosurf), 2.5ml/kg, administered under direct laryngoscopy using a surfactant instillation catheter (mist) 16g angiocath (becton dickinson, sandy, ut, usa). a second dose of calfactant (infasurf) 3ml/kg or poractant alfa (curosurf), 1.25ml/kg, will be administered via mist their fio2 reaches the threshold of 30% between 6 and 48 hours after the first dose. no further surfactant should be given in the first 7 days unless the infant reaches the intubation criteria. post-intervention management other than the requirement to adhere to intubation criteria in the first week, and in some cases perform a room air trial at 36 weeks corrected gestation, management will be at the discretion of the clinical team. titration of cpap pressure is encouraged, with a permitted maximum of 8 cm h2o. use of nasal ippv is allowable for apnea, but discouraged for rds and should only be after at least one dose of surfactant has been given. early caffeine therapy is expected. criteria for intubation: enrolled infants on cpap will be intubated if: * fio2 ≥0.45 for 15 minutes, or if there is unremitting apnea (\> 6 episodes/hour requiring intervention or in the opinion of the treating physician) or persistent respiratory acidosis (ph\ 60) on blood gasses at least 30 minutes apart or metabolic acidosis refractory to treatment. * need for an anesthetic or an intervention requiring intubation these criteria apply during the first week of life, and to the first episode of intubation only. if the infant is intubated it is expected that another dose of surfactant will be administered.

Eligibility criteria:
inclusion criteria: * preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (ncpap) and fio2 ≥0.30 exclusion criteria: * infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress. * infants who require emergent intubation will not be enrolled in the interventions.

Keywords: pulmonary surfactant cpap neonate
the effect of treatment with teriparatide and zoledronic acid in patients with osteogenesis imperfecta

Conditions: Osteogenesis Imperfecta

Summary: osteogenesis imperfecta (oi) is an inherited disease of the connective tissue. symptoms are fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. the aim of the present study is to investigate the effect of treatment of adult oi patients with bisphosphonate (zoledronic acid), parathyroid hormone (pth) or placebo on bone mass, fracture risk and quality of life. the investigators will therefore conduct a double blind, placebo controlled trial, taking genotype and previous antiresorptive therapy into account.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of osteogenesis imperfecta * bmd\<-1.0 or exclusion criteria: * creatinine clearance \<30ml/min * treatment with glucocorticoids \> 5mg daily during the last 3 months * metabolic bone disease or vitamin d deficiency * liver or kidney disease * contradictions to zoledronic acid or teriparatide * increased baseline risk of osteosarcoma

Keywords: drug therapy adult
passive calf stretching therapy in peripheral artery disease

Conditions: Peripheral Artery Disease; Claudication, Intermittent

Summary: the goal of this clinical trial is to assess the effects of passive calf muscle stretching in patients diagnosed with peripheral artery disease (pad). the main question it aims to answer are: 1. to determine if daily calf muscle stretching at home improves calf muscle and vascular health. 2. to determine if daily calf muscle stretching at home improves walking performance. participants will use inflatable ankle splints for 30 minutes a day, 5 days a week for 4-weeks on both days and 4-weeks of no stretching.

patients with peripheral artery disease will passively stretch their calf muscles using a stretch device on both feet for 30 minutes a day for 4 weeks. blood vessel health and size, length and function of the calf muscles and tendons and walking performance will be measured. joint and foot movements as well as calf muscle oxygen levels will be measured during walking performance tests.

Eligibility criteria:
inclusion criteria: * presence of pad * stable condition (pad symptoms) for at least 3 months * age 40-85 * men and women who are not pregnant or nursing exclusion criteria: * ischemic leg pain at rest; critical limb ischemia (ulceration or gangrene) * any condition other than pad that limits the ability to walk * major surgery or lower extremity revascularization surgery in the past 6 months * myocardial infarction within past 6 months or unstable angina * severe lung disease (on supplemental oxygen or frequently use rescue inhalers) * participants with non-compressible vessels (abi \> 1.40) * habitual exercise (30 minutes of continuous activity on 3 or more days per week) * current tobacco smoker or use of nicotine-containing products * pregnant or nursing women * history or ankle reconstruction or surgery recent history (\<1 year) of injuries to the ankle, achilles tendon, or feet * history of rheumatoid arthritis or other degenerative joint disease * major medical illness treatment during the prior 12 months * uncontrolled hypertension * uncontrolled diabetes * inability to walk on a treadmill at a slow pace (1.0 mile/hour)

Keywords: endothelial dysfunction
a bidirectional study in exploring the dynamic changes of plasma and urine metabolites of head and neck cancer

Conditions: Head and Neck Cancer; Metabolite

Summary: dynamic changes in the internal environment of the body are important clues for early detection, diagnosis and even cure of head and neck tumors. this project uses the combination of proteomics technology and liquid biopsy to provide more primary prevention strategies for early intervention, secondary prevention strategies for early detection and treatment, and clues for the study of the mechanism of dynamic evolution of head and neck tumors.

head and neck cancer is the seventh most common malignant tumor in the world, and china is a country with a high incidence of head and neck cancer. dynamic changes in the internal environment of the body are important clues for early detection, diagnosis and even cure of head and neck tumors. the occurrence and development of head and neck cancer is complex, so it is particularly important to explore the changes of internal environment in its clinical pathway. therefore, we conducted this study to investigate the changes of plasma and urine metabolites during the development of head and neck cancer. (1) retrospective cohort: 250 patients were recruited, including 125 patients with head and neck cancer and 125 healthy people.,(2) prospective cohort: 250 patients were recruited, including 125 head and neck cancer patients and 125 healthy people. during the course of the study, the subjects will not be given or provided with any randomized or any treatment driven by the study protocol. if it is clinically applicable, the treatment physician shall make the treatment decision and choose the treatment plan at his discretion.

Eligibility criteria:
inclusion criteria: 1. head and neck cancer patients * age 18-75 years old; * male or non-pregnant female; * patients who were normatively diagnosed as head and neck tumors according to the who standards of 2017; * the general situation is good: kps score ≥70; * no other malignant tumors. 2. healthy people * age 18-75 years old; * male or non-pregnant female; * no history of head and neck related diseases or other diseases known to affect blood lipid/protein metabolism. exclusion criteria: * previous history of non-research related head and neck conditions or other known effects on blood metabolism (except for controlled type 2 diabetes); * with a history of other malignancies (except cell carcinoma and cervical carcinoma in situ); * diseases that require long-term use of immunosuppressive drugs (including steroids), including but not limited to congenital or acquired immunodeficiency disorders or active central nervous system rotations, metastatic cancer, active infection, or uncontrolled heart disease; * concurrent with other uncontrolled serious medical conditions, such as unstable heart disease that requires treatment disease, poorly controlled diabetes (fasting blood glucose \> 1.5× the upper limit of normal), mental illness and a history of severe allergies. * bmi less than 18 or greater than 25.
effectiveness and safety of probiotics in protecting liver function

Conditions: Alcohol Abuse

Summary: to evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers


Eligibility criteria:
inclusion criteria: 1. a history of long-term heavy alcohol consumption, equivalent to ethanol intake ≥40g/day for over 1 year. the conversion formula is: ethanol (g) = volume of ethanol-containing beverage (ml) × ethanol content (%) × 0.8 (specific gravity of ethanol); 2. body mass index (bmi) between 18kg/m² and 25kg/m²; 3. voluntarily signed a written informed consent form, agreeing to participate in this study; 4. agreed to comply with the study protocol and restrictions; 5. subjects (including male participants) have no plans for conception from 14 days prior to screening until 6 months after the end of the trial and voluntarily agree to use effective contraception. exclusion criteria: 1. patients with various types of viral hepatitis, autoimmune liver disease, drug-induced liver damage, vascular liver disease, genetic metabolic liver disease, or primary liver cancer; 2. individuals who have recently consumed substances with similar functions to the tested product, potentially affecting the study results; 3. patients with severe allergies or immune deficiencies; 4. pregnant, breastfeeding, or women with plans for pregnancy; 5. individuals with severe diseases of vital organs such as cardiovascular, pulmonary, hepatic, renal conditions, or those with diabetes, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system disorders; 6. individuals who have used antibiotics within the past two weeks; 7. participants who did not comply with the required consumption of the tested product or missed follow-ups, making it impossible to evaluate the effectiveness; 8. other participants deemed unsuitable by the researchers.
lanreotide 120mg effectiveness in subjects with pancreatic neuroendocrine tumours (pannet) in routine clinical practice.

Conditions: Pancreatic Neuroendocrine Tumor

Summary: the purpose of the protocol is to estimate the progression-free survival (pfs) rate in subjects diagnosed with pannet, according to investigator assessment, at 24 months after treatment initiation with lanreotide 120 mg every 28 days.


Eligibility criteria:
inclusion criteria: * subjects aged ≥ 18 * subjects diagnosed of functioning or non-functioning pannet, g1/ g2 (ki67≤10%) unresectable locally advanced tumour or metastatic disease, who have been treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months * subject not progressive at inclusion study visit according to investigator assessment, and using as a reference lanreotide initiation * subject with eastern cooperative oncology group (ecog) ≤2 exclusion criteria: * subject who is participating in an interventional study * pregnant or breast-feeding women * subject who has received any previous therapy for pannet (such as octreotide lar, molecular targeted therapy (mtt), peptide receptor radionuclide therapy (prrt), chemotherapy, etc.) except short-acting octreotide subcutaneous (sc) used for symptomatic control of functioning tumours