Kornimate/medical-research-clean huggingface dataset:
the ultracyt study - is eu-tirads useful in selecting nodules for fine needle aspiration cytology?

Conditions: Thyroid Cancer; Thyroid Nodule

Summary: this is a randomized study evaluating selective fine-needle aspiration cytology based on structured ultrasound using eu-tirads versus non-selective ultrasound guided cytology. primary outcome is frequency of suspicious cytology (bethesda iii-vi) which is expected to be higher in the selective group compared to the non-selective group. secondary outcome is the frequency of malignancy which is expected to be equal in both groups. however, the investigators do not expect to reach statistical significance for the secondary outcome according to power calculations.

thyroid nodules are common in the population, and the reported incidence of thyroid cancer is increasing in most parts of the world. palpable thyroid nodules are reported in 4-5 per cent of the population, of which 5-10 per cent are malignant. the reported incidence of thyroid nodules on ultrasound is higher. eu-tirads has been shown in retrospective cohort studies to accurately stratify thyroid nodules with respect to risk of thyroid cancer. eu-tirads has been used in western sweden since 2017 and in 2021 it was implemented in the swedish national guidelines for thyroid cancer. to the knowledge of the investigators, no randomized controlled study has been carried out validating eu-tirads. this multicenter regional study aims to investigate the safety of using selective cytology using eu-tirads. primary outcome is the result of cytology suspicious of thyroid cancer. in the selective group, low risk nodules will not undergo cytology and therefore the frequency of cytologically suspicious nodules (bethesda iii-vi) is expected to be higher in this group.

Eligibility criteria:
inclusion criteria: * patients referred to ultrasonography of the thyroid due to goiter symtoms or positive findings on fdg-pet exclusion criteria: * patients previously examined with ultrasonography of the thyroid * patients who have previously undergone thyroid surgery

Keywords: ultrasonography cytology thyroid cancer thyroid nodule diagnostics
a safety and tolerability study of crenolanib in combination with chemotherapy in newly diagnosed acute myeloid leukemia patients with flt3 mutations

Conditions: Newly Diagnosed AML With FLT3 Activating Mutations

Summary: this pilot study is designed to evaluate the safety and tolerability of oral crenolanib besylate given sequentially during standard induction and consolidation chemotherapy in patients with newly diagnosed aml with flt3 activating mutations.


Eligibility criteria:
inclusion criteria: 1. unequivocal diagnosis of aml based on the who classification, excluding acute promyelocytic leukemia 2. no prior therapy for aml, except for hydroxyurea, in this setting is allowed. 3. subjects with aml evolving from mds may have received prior mds therapy with demethylating agents 4. subjects must have tested positive for flt3-itd and/or other flt3 activating mutations 5. age ≥18 years 6. ecog ps 0 - 2 7. adequate liver function, defined as normal total bilirubin, alt ≤2.0x uln, and ast ≤2.0x uln measured within 24 hours prior to crenolanib commencement 8. adequate renal function, defined as serum creatinine ≤1.5x uln or gfr \>50 ml/min 9. negative pregnancy test (serum or urine) for women of childbearing potential (wocbp) • women considered not of childbearing potential include any of the following: no menses for at least 2 years or menses within 2 years but amenorrheic for at least 2 months and luteinizing hormone (lh) and follicular stimulating hormone (fsh) values within normal range (according to definition of postmenopausal for laboratory used) or bilateral oophorectomy or radiation castration and amenorrheic for at least 3 months or with bilateral tubal ligation 10. wocbp must practice contraception. acceptable methods of contraception are double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, tubal ligations, and abstention 11. male patients (except those with prior surgical contraceptive procedures) with female partners who are of childbearing potential: recommendation is for male and partner to use effective contraceptive methods, such as latex condoms, during the study 12. able and willing to provide written informed consent exclusion criteria: 1. pre-existing liver diseases (i.e., cirrhosis, chronic hepatitis b or c, nonalcoholic steatohepatitis, and sclerosing cholangitis, etc.) 2. active cns leukemia 3. subject with concurrent severe and/or uncontrolled medical conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy 4. nyha class iii-iv heart failure, myocardial infarction \<6 months prior to study entry, and/or serious arrhythmia requiring anti-arrhythmic therapy 5. unable to swallow pills 6. major surgical procedures within 14 days of administration of crenolanib (does not include line placement as needed for chemotherapy administration). 7. unwillingness or inability to comply with protocol. 8. concurrent use of other investigational agents. 9. subjects who are not eligible for standard chemotherapy
evaluation of thoracic impedance tomography during robotic surgery

Conditions: Atelectasis

Summary: the evaluation of distribution of mechanical ventilation during robotic surgery


Eligibility criteria:
inclusion criteria: * age\>18 * informed consent * robotic surgery exclusion criteria: * age\<18 * no consent for the study
feeding the rainbow to investigate endothelial dysfunction

Conditions: Dietary Modification; Cardiovascular Disease

Summary: the primary purpose of this study is to compare the change in blood carotene concentration between a food-based versus nutritional supplement-based intervention. this study will randomize up to 60 healthy volunteers to receive either carotenoid-enriched food; natural, mixed carotenoid supplementation; chlorophyll complex or placebo supplementation. blood carotene levels will be measured before and after 28 days of supplementation. preliminary data will also be collected on several biomarkers associated with vascular inflammation and endothelial dysfunction. these biomarkers will be measured before and during a fast food control meal at the beginning and end of the intervention period.


Eligibility criteria:
inclusion criteria: * adults aged 18-65 * in good health by the absence of exclusion criteria on standardized medical history interview * willingness to be randomized * willingness to complete multiple blood draws following fast food consumption on two occasions over 28 days exclusion criteria: * children \<18 years * current use of carotenoid supplements (not including typical multivitamins containing beta-carotene) * current use of polyphenol supplements including green tea, resveratrol, pine bark extract, cocoa, and/or grape skin extract * current use of aspirin, statins or regular (\>2 per week) use of nsaid medications * current smoking or past smoking greater than 3 packs total or currently living with a smoker * excessive alcohol intake (\> 3 drinks per day) or history of alcoholism * known exposure to asbestos * autoimmune disease * hemachromatosis * history of gallbladder disease including gall stones or gall bladder removal * pre-diabetes, metabolic syndrome or diabetes (1 or 2) * established cardiovascular disease (arrhythmia, heart failure, hypertension treatment or untreated stage ii hypertension (≥160/90; stage ii technically diastolic ≥100mmhg, will maintain diastolic cutoff of 90mmhg), past mi or stroke) * renal or liver disease (viral hepatitis, non-alcoholic steatohepatitis "fatty liver") * acute infection except viral colds * residual injury/pain/limitation from trauma * chronic musculoskeletal disorders including osteoarthritis requiring pain medications * psychiatric disorders that would impair completion of research tasks * allergies to supplied foods * anyone on a medically-prescribed diet * \>3.5 servings fruits/veggies per day * inability to consume entire study control meal w/in specified timeline (30 minutes) * current pregnancy or breast feeding * refusal to participate in blood draws following the control meal.

Keywords: mixed carotenes
exploring hand function in people with schizophrenia based on perspective of sensorimotor control

Conditions: Schizophrenia

Summary: the study aims to explore the hand function in people with schizophrenia in the chronic stage.


Eligibility criteria:
inclusion criteria: * age between 20-65 years old * diagnosis with schizophrenia or schizoaffective disorder by psychiatrists according to dsm5. * remaining the same antipsychotics and the symptom was stable for at least one month before the study. * be able to follow comments and have sufficient cognitive ability assessed by mini-mental state examination score \>24 exclusion criteria: * substance abuse or other medical conditions that may affect movements. * using other non-antipsychotics that will affect movements in the same period.

Keywords: hand function sensorimotor motor control theory
environmental surveillance (es) for polio and amr using the taqman array card

Conditions: Polio

Summary: this study will be used to develop a tool to streamline poliovirus environmental surveillance for the polio endgame and to provide a tool for detecting polio in places where there is no capacity to carry out the gold standard culture-based detection.

this environmental surveillance tool will also include antimicrobial resistance (amr) genes to describe resistome profile in environmental samples and to better inform us of the potential risks of exposure to these environments

Eligibility criteria:
inclusion criteria * birth-4 years of age * reside in selected urban slums of mirpur dhaka, bangladesh * receiving bopv immunization exclusion criteria: * parent unwilling to consent
study to compare the anti-tetanus neutralizing antibody titers and safety of tnm002 injection with human tetanus immunoglobulin or placebo in adult volunteers

Conditions: Tetanus

Summary: the primary objective is to compare the anti-tetanus neutralizing antibody titers of tnm002 injection with human tetanus immunoglobulin (htig) following a single intramuscular (im) injection in chinese adult volunteers.


Eligibility criteria:
inclusion criteria: 1. chinese male or female adults aged ≥ 18 years; 2. healthy volunteers or volunteers with stable chronic diseases; 3. volunteers who provide signed written informed consent form. exclusion criteria: 1. history of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins; 2. any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation; 3. history of alcohol or other substance abuse.
risk factors for chronic prostatitis patients in northwest china

Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Summary: the goal of this observational study is to learn about the risk factors of lifestyle, medication and sexual habits in adult chronic prostatitis / chronic pelvic pain syndrome patients. the main questions it aims to answer are: * is lifestyle, medication, and sexual habits related to chronic prostatitis / chronic pelvic pain syndrome * is there any medication available to protect men from chronic prostatitis / chronic pelvic pain syndrome. participants will: * independently receive a survey questionnaire on lifestyle, medication, and sexual habits. * symptomatic individuals will undergo additional prostate fluid examination for diagnosis. researchers will compare healthy adult males to see if there are differences on lifestyle, medication and sexual habits between the two groups.

all participants were asked to fill out a questionnaire which was modified based on zhang ran's research. the questionnaire contained the following parts: patient's general situation, dietary habits, disease status, medication, lifestyle, sexual habits and nih-cpsi index (national institutes of health chronic prostatitis symptom index). furthermore, the patients underwent digital rectal examination, expressed prostatic secretion microscopy and microbial culture, urinalysis, urine microbial culture and transrectal ultrasonography.

Eligibility criteria:
inclusion criteria: * discomfort or pain in the pelvic region or perineum; * symptoms lasting for at least 3 months; * nih-cpsi pain score of ≥ 4; * controls are volunteers who do not present any prostatitis-related symptoms. exclusion criteria: * prostate cancer; * benign prostatic hyperplasia with a post-void residual urine volume of \>50 ml; * acute urinary tract infection.
zolmitriptan nasal spray versus eletriptan in the acute treatment of migraine

Conditions: Acute Migraine; Migraine Headache; Headache Disorders

Summary: the purpose of this study is to compare the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet in the acute treatment of migraine. to develop and evaluate a set of importance weights for a predefined set of treatment attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet. to contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at early time points. to analyze the patterns of self-reported tolerability of migraine sufferers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.

an open-label, randomized, cross-over study comparing the efficacy of zolmitriptan 5 mg nasal spray with eletriptan 40 mg tablet at early time points. satisfaction endpoints include global assessment of preference, overall satisfaction and effectiveness as well as tolerability of both medications.

Eligibility criteria:
inclusion criteria: * 15 to 70 years old * migraine attacks according to the criteria proposed by the ihs * 3-12 migraine attacks per month * adequate contraception * willing and able to give written informed consent * willing and able to complete the entire course of the study \& comply with instructions * stable dose of preventive medication for at least 4 weeks exclusion criteria: * disorders listen in groups 5-11 of the ihs classification * subject is pregnant or lactating. * significant medical or psychiatric disease * subject has a history of symptoms suggestive of ischemic heart disease (angina, myocardial infarction, documented silent ischemia) or other vascular disease, including prinzmetal angina, claudication, wolff-parkinson-white syndrome, or other cardiac accessory conduction pathway arrhythmia * subject has uncontrolled hypertension. * subject has history of basilar, ophthalmoplegic, or hemiplegic migraine or serious neurologic condition associated with headache * subject has used monoamine oxidase a inhibitors (maoi-as) within 2 weeks of randomization * subject has had serious adverse event while using another 5-ht agonist, or previous serious adverse event while using zolmitriptan or hypersensitivity to zolmitriptan or eletriptan * using cyp3a4 inhibitors listed by the fda as contraindicated with eletriptan * moderate/severe hepatic/renal impairment * subject currently using cimetidine * concomitant medication treatment with a triptan, ergotamine or methysergide.

Keywords: migraine acute migraine headache
endoscopy in ckd with iron deficiency anemia

Conditions: Chronic Kidney Diseases; Iron-Deficiency Anemia

Summary: iron deficiency anemia is very common in ckd patients. data about gastrointestinal lesions in arab patients are insufficient.

iron deficiency anemia without gastrointestinal symptoms needs to be assessed in patients with chronic kidney disease.

Eligibility criteria:
* patients with egfr is less than 60 ml/m/1.73 m2. * patients with iron deficiency anemia. * absence of gastrointestinal symptoms.
study of su011248 in combination with docetaxel in patients with metastatic breast cancer

Conditions: Breast Neoplasms

Summary: this study is to evaluate the safety of su011248 (sunitinib/sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.


Eligibility criteria:
inclusion criteria: * breast cancer with evidence of unresectable, locally recurrent or metastatic disease * candidate for treatment with docetaxel exclusion criteria: * prior chemotherapy in the advanced disease setting * inflammatory breast cancer * her2 positive disease

Keywords: advanced sunitinib (sutent) docetaxel phase 1b
blood pressure target in acute stroke to reduce hemorrhage after endovascular therapy

Conditions: Acute Stroke; Blood Pressure; Cerebral Hemorrhage

Summary: a randomized, multicenter study comparing two strategies: 1 / standard management of systolic blood pressure according to international recommendations (systolic blood pressure \<185 mm hg) versus 2 / intensive blood pressure management systolic with a target \<130 mm hg.

patients will be followed for 3 months: * inclusion after reperfusion: clinical evaluation with nihss (national institute of health stroke score) score, measurement of blood pressure. * within 24 hours after reperfusion: blood pressure measurements * at 24 hours: measurement of blood pressure (t0 + 24 h and evaluation of the nihss score. * between 24 and 36 hours :cerebral scan (assessment of hemorrhagic transformations and cerebral infarction volumes). for some centers: cerebral mri without injection between h24 and h36 * 72 hours after reperfusion: cerebral scanner in case of hyperdensity on the initial scanner * 3 months after reperfusion: disability assessment by rankin score

Eligibility criteria:
inclusion criteria: * intracranial occlusion of internal carotid arteries and/or proximal middle cerebral (segment m1) diagnosis made on initial imaging. * reperfusion after a thrombectomy procedure (defined by a 2b-3 tici score -thrombolysis in cerebral infarction- score). exclusion criteria: * per-procedure hemorrhagic complications (prior to reperfusion) * systolic blood pressure at baseline \<130 mm hg within one hour of recanalization * pre-existing stroke handicap defined by a rankin score (modified scale, mrs)\> 3 * hemodynamically significant carotid stenosis * occlusion of the isolated cervical carotid artery * known pregnancy * legal protection * non-affiliation to a social security scheme * refusal of the patient (or of his / her relatives in case of urgent inclusion)

Keywords: acute stroke blood pressure cerebral hemorrhage
tracing changed production of red blood cells

Conditions: Erythrocytosis; Erythropoiesis Abnormal

Summary: in competitive sport, it is illegal to manipulate erythropoiesis. manipulated erythropoiesis can indirectly be identified by atypical fluctuations in key haematological variables. however, this method also has limitations and as it is known that some athletes still manipulate erythropoiesis it is necessary to develop new and more sensitive detection methods. the primary purpose of the study is to examine the importance of altered erythropoiesis for surface and intracellular erythrocyte proteins, the number of immature reticulocytes, and for the haematological characteristics of the erythrocyte, such as volume, haemoglobin concentration and concentration of glycosylated haemoglobin, to assess whether these can be used to identify changed erythropoiesis. furthermore, the aim is to examine whether these parameters are affected by freezer storage of erythrocytes.


Eligibility criteria:
inclusion criteria: * healthy men * 18-40 years * physical fitness rating more than 50ml/kg/min * non-smokers * blood pressure \<130/90 mmhg * hemoglobin concentration 7-10.5 mm. exclusion criteria: * blood donor who has donated blood within the last three months * participation in other concurrent clinical trials * to participate in competitive sport during or three months after the study.
hyperbaric oxygen treatment as adjuvant treatment for frost injury

Conditions: Wound (Morphologic Abnormality)

Summary: the aim of this study is to see weather hyperbaric oxygen treatment is beneficial as adjuvant treatment for frost damage. the investigators hope to include at least 20 patients in a randomized manner. half of the patients are randomized to hyperbaric oxygen, and half of the patients are randomized not to have hyperbaric oxygen treatment. under hypotheses: the number og surgeries is reduced by hyperbaric oxygen treatment as adjuvant treatment for frost damage. the functional level of the frost damaged patient is better after 6 and 12 months when also treated with hyperbaric oxygen treatment for frost damage.


Eligibility criteria:
inclusion criteria: * age 18-70. frost damage grade ii-iv. inclusion is needed within 48 hours from time of damage. exclusion criteria: * pregnancy. ventilator treatment. problems with equalizing. high grade heart failure. chronic obstructive lung disease of high grade. treatment over 3 days after time of damage. serious claustrophobia/psychiatric illness.

Keywords: frost injury
efficacy and safety of moxonidine in indian patients

Conditions: Hypertension

Summary: the purpose of this study is to demonstrate efficacy and safety of moxonidine in indian subjects.


Eligibility criteria:
inclusion criteria: hypertension exclusion criteria: severe concomitant diseases, chf, secondary hypertension, severe hypertension, significant hepatic disease, unstable angina

Keywords: efficacy and safety of moxonidine in indian hypertensives
a trial of heparin in patients with severe sepsis who are undergoing treatment with drotrecogin alfa (activated)

Conditions: Sepsis

Summary: the purpose of this study is to evaluate the relative efficacy and safety of prophylactic heparin co-administration during drotrecogin alfa (activated) infusion in the treatment of severe sepsis in the adult.


Eligibility criteria:
inclusion criteria * adults greater than or equal to 18 years of age * receiving inpatient treatment for severe sepsis * indicated for treatment with drotrecogin alfa (activated) under approved label in the country where the patient is enrolled exclusion criteria * contraindicated for heparin treatment * require a higher dose of heparin than defined in the trial * have acute or chronic renal failure with an estimated creatinine clearance less than 30ml/min * weigh more than 135 kg (297 pounds) * are not expected to survive 28 days given their medical condition.