Kornimate/medical-research-clean huggingface dataset:
mri iron oxide imaging for lymph node staging in esophageal cancer

Conditions: Esophageal Cancer

Summary: this research study is evaluating a new imaging method using mri (magnetic resonance imaging) to evaluate lymph nodes for evidence of tumor spread from esophageal cancer. this mri study involves an intravenous contrast called ferumoxytol (ferahemetm).

this research study is a pilot clinical trial, which is the first time investigators are examining this study intervention. this study tests the safety of the investigational intervention (mri imaging with ferumoxytol) and assesses the feasibility of identifying malignant lymph nodes (lymph nodes that have tumor in them) by comparing the experimental mri findings with the final pathology report from surgery. this iron-based agent currently has approval from the u.s. food and drug administration (fda) for use in iron replacement therapy, however, its use in mri imaging is not fda-approved and is thus experimental in this trial.

Eligibility criteria:
inclusion criteria: * participants may have histologically confirmed esophageal cancer or lesion suspicious for esophageal cancer which is deemed surgically resectable. * patients eligible for the trial may have previously completed neoadjuvant chemoradiation per standard protocols prior to mri imaging, without any limitations on dose, duration or type of prior treatment as this is not the focus of the current study. * eligible patients must be 18 years or older in order to consent for this trial. individuals under the age of 18 are excluded because safety studies including dosing or adverse event data in this population are currently not available. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients with known allergies or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharides * individuals who are pregnant or lactating. as part of their routine preoperative testing, all women of child bearing age receive a pregnancy test. the research staff will follow up on these results in order to determine eligibility. women who have had a hysterectomy or have not had menses for \> 24 months will not be required to undergo a pregnancy test. pregnant women are excluded from this study because there is unknown risk associated with ferumoxytol (us fda risk category c: there are no controlled studies in women, or no studies are available in either animals or women). because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother, breastfeeding women will be excluded from this study * iron saturation above the upper limit of normal * individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease * individuals with a contraindication to mri, such as the presence of metallic prostheses or implanted metal device (e.g. infusion pump, defibrillator)

Keywords: esophageal cancer lymph nodes tumor
comparison of post-operative complications of bone augmentation at anterior of maxilla after periosteal releasing incision with two techniques diode laser and scalpel

Conditions: Post-operative Pain

Summary: the aim of this study was to investigate if using lasers instead of scalpel for flap advancement in bone augmentation procedures would reduce post-operative swelling and pain.

guided bone regeneration (gbr) is a well established method to augment excessive alveolar bone loss before and at the time of implant placement. primary closure of soft tissue is a prerequisite for successful bone augmentation procedures. adequate flap advancement is a key factor for tension free primary wound closure. the tension free flap is usually attained by incising the buccal flap using scalpels. however, this procedure, especially in cases with major flap advancement, results in increased patient morbidity after surgery. swelling and hemorrhage during the first week after surgery have a negative effect on patient's quality of life. currently, lasers are widely used as a tool for soft tissue management and diode laser appears to be an effective tool for incision and excision of the soft tissue. the major advantageous property of lasers is ablation of tissue together with effective hemostasis, minimal swelling and virtually no pain.

Eligibility criteria:
inclusion criteria: * patients with the need for a single-tooth replacement in the maxilla by implant and simultaneous gbr exclusion criteria: * general contraindication for bone augmentation or implant surgeries, * existence of swelling or pain at the time of surgery, * smoking habits, pregnancy, and lactation.

Keywords: post-operative pain diode laser
a prospective study comparing contour se™ microspheres to embosphere® microspheres for treating symptomatic uterine fibroids with uterine fibroid embolization (ufe)

Conditions: Leiomyoma; Uterine Fibroids; Uterine Neoplasms; Menorrhagia; Leiomyomatosis

Summary: the purpose of this study is to demonstrate comparability between contour se™ microspheres and embosphere® microspheres for achieving post ufe fibroid devascularization in women with symptomatic uterine fibroids.

the purpose of this prospective randomized single-center study is to demonstrate comparability using contour se™ microspheres (700-900µ and 900-1200µ) using a near stasis endpoint and embosphere® microspheres (500-700µ) using a "prune tree" endpoint for achieving post ufe fibroid devascularization in women with symptomatic uterine fibroids. the study will demonstrate (with the use of contrast enhanced magnetic resonance imaging (mri) at baseline and 24-hours post embolization) that uterine fibroids can successfully be devascularized using the embolization protocols. contrast enhanced mri will be performed at baseline, 24-hours, and 3-months post ufe. the subjects will be followed through 12-months post ufe and change from baseline in symptom severity (quality of life (qol) questionnaire) will be assessed at 3 months and 12 months.

Eligibility criteria:
inclusion criteria: * one or more of the following symptoms: abnormal menstrual bleeding, infertility related to fibroids, pelvic pain, and/or bulk/pressure related symptoms attributed to fibroids: i.e., pelvic pressure, abdominal enlargement, abdominal bloating, gastrointestinal pressure symptoms (backache, constipation), dysfunction of the urinary bladder (urinary frequency, urinary retention), vaginal pressure, and rectal pressure. * severity of the symptom(s) warrants invasive treatment * willing and able to complete the follow-up requirements outlined in the study design section of the protocol * willing to sign a consent form exclusion criteria: * active pelvic inflammatory disease or infection * any malignancy of the pelvic region * endometrial neoplasia or hyperplasia * presence of one or more submucosal fibroid(s) with more than 50% growth into the uterine cavity * presence of pedunculated serosal fibroid as the dominant fibroid(s) * fibroids with significant collateral feeding by vessels other than the uterine arteries * presence of arteries supplying the fibroid are not large enough to accept 700-900 micron or 900-1200 micron microspheres * coagulopathy * atypical anatomy that will not allow for bilateral ufe * subject with known severe contrast allergy * subjects with known moderate to severe renal disease

Keywords: leiomyoma uterine fibroids uterine fibroid embolization (ufe) uterine artery embolization (uae) uterine neoplasms menorrhagia
safety and efficacy trial of dna vaccines to treat genital herpes in adults

Conditions: Genital Herpes Simplex Type 2

Summary: the purpose of this study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (hsv-2).

this is a dose escalation study to evaluate the safety, immunogenicity, and efficacy of 3 doses of hsv plasmid dna (pdna) vaccines formulated with vaxfectin® in subjects with a minimum of 1 year of reported history of genital herpes, and either 2 to 9 recurrences within the year prior to screening, or 2 to 9 recurrences per year prior to starting suppressive therapy.

Eligibility criteria:
inclusion criteria: * hsv-2 seropositive * a minimum of 1 year of reported history of genital herpes and either 2 to 9 recurrences within the year prior to screening or 2 to 9 recurrences per year prior to starting suppressive therapy exclusion criteria: * history of receiving an investigational hsv vaccine * chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes * pregnant or breastfeeding

Keywords: herpes simplex virus, type 2 herpes hsv-2
personalizing interventions using real-world interactions

Conditions: Social Interaction; Schizophrenia Spectrum and Other Psychotic Disorders

Summary: social functioning deficits are among the most disabling and difficult to treat aspects of schizophrenia. an essential component of social functioning is metacognition-a process that is profoundly disrupted in schizophrenia and represents the ability to reflect upon the mental states of oneself and others. to date, treatment efforts in schizophrenia have been hindered by barriers in accurately monitoring client's real-world social interactions. recently, wearable technologies have evolved to provide therapists with innovative, ecologically-valid tools. the electronically activated recorder is a wearable audio recorder that collects behavioral samples at pre-programmed intervals; it holds great promise as a method for yielding concrete, real-world examples of social interactions that can be used by therapists in session to enhance metacognition. despite the immense costs of social functioning deficits, no previous studies have investigated whether functioning can be improved by integrating wearable audio recorders with psychosocial interventions. by enhancing therapy using a wearable recording device, this proposal's primary goal is to implement a novel intervention that targets metacognitive deficits to improve social functioning. the novel intervention will be tailored to individual clients-based on the content of recorded social interactions-in a way that is not possible using traditional psychotherapy. this will allow clients and therapists to step out of the therapy room by offering a window into how clients process material in real-world interactions. in this study, a randomized controlled trial will be conducted with two schizophrenia groups receiving six months of individualized: 1) metacognition reflection and insight therapy (merit) alone (standard merit); and 2) tailored merit using wearable audio recorders. in this study, our specific aims will test feasibility, effectiveness, and acceptability of tailored merit.


Eligibility criteria:
inclusion criteria: * positive screen for metacognitive dysfunction * serious mental illness diagnosis (schizophrenia-spectrum) * age 18-60 * english fluency * currently in non-acute phase of illness exclusion criteria: * inability to provide informed consent * current substance dependence * documented intellectual disability
hyperpolarized 13c-pyruvate metabolic mri with traumatic brain injury

Conditions: Traumatic Brain Injury; Subarachnoid Hemorrhage

Summary: the purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic mri to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (tbi). this study will also compare hp pyruvate mri-derived metrics in tbi patients with healthy subjects as well as subarachnoid hemorrhage (sah) patients to better understand if metabolic magnetic resonance imaging scan (mri) can improve our ability to diagnose a tbi. the fda is allowing the use of hyperpolarized \[1-13c\] pyruvate (hp 13c-pyruvate) in this study. up to 15 patients (5 with tbi, 5 with sah, and 5 healthy volunteers) may take part in this study at the university of maryland, baltimore (umb).


Eligibility criteria:
inclusion criteria: * history of acute head injury with or suspected non-penetrating acute tbi * suitable to undergo contrast-enhanced mri * negative serum pregnancy test exclusion criteria: * inability to undergo mri scan * inability to receive iv mri contrast agents secondary to severe reaction or renal insufficiency * positive pregnancy test
a study regarding tissue response during and after treatment for anal cancer

Conditions: Anal Cancer

Summary: the aim of this study is to improve the understanding for the tumour biology in relation to treatment response in patients with anal cancer by examining: * the tumour microenvironment * the localisation of and cellular interactions between the tumour and immune cells * the gene and protein expression by cells present in the tumour and surrounding tissue.

all adult patients with anal cancer presenting within the sahlgrenska university hospital catchment area or treated at any time at sahlgrenska university hospital are eligible and will be asked to participate. the patients that are newly diagnosed or that have a suspected recurrence will be offered to enter the study with biopsies as well as blood samples during the diagnostic examination that is performed under anaesthesia. biopsies will then be taken during follow-up exams if applicable. biopsies will also be taken during surgery if that is scheduled and in cases where surgery is not necessary biopsies will be taken if the patient undergoes examinations under anaesthesia after treatment cessation. if it is not possible to take biopsies prior treatment blood samples will still be drawn.

Eligibility criteria:
inclusion criteria: * newly diagnosed or recurrent anal cancer exclusion criteria: * no diagnosis of anal cancer, contraindication to biopsies and blood samples

Keywords: anal cancer, tumour micro environment, chemoradiotherapy
the relationship between cd138 count of endometrium and reproductive outcome

Conditions: Infertility

Summary: it's well known, endometritis affects reproductive outcomes. though cd138 counting as one new diagnosis measure for endometritis, diagnostic criterion of this measure isn't consistent. and if the cd138 counting is correlation to the outcome of reproductive is not clear. firstly, this study aims to explore the relationship between endometrial cd138 count and pregnancy outcome following frozen embryo transfer in natural cycles. secondly , the investigators want to find a cut-off value which is related to reproduction outcome.


Eligibility criteria:
inclusion criteria: * age between20 and 38 years; * regular menstrual cycles; * body mass index (bmi) ranged from 18 to 25 exclusion criteria: * uterine abnormalities; * intrauterine adhesions（moderate - severe）, advanced endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids \>4.0 cm and/or endometrial pressure)
vascular inflammation in adolescents with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus; Coronary Artery Disease

Summary: the purpose of this study is to find out if diabetes damages the blood vessels of adolescents with good diabetes control compared to adolescents with less optimal control.

many published studies reveal that adult patients with t1dm can have early, silent and more advanced vessel wall thickness than normal subjects. this is influenced by the degree of their blood sugar control. if this is happening in adolescents, we want to know what proportion of adolescent children with type 1 diabetes show signs of early blood vessel damage. we also want to learn if these signs of damage are linked to other factors such as how long someone has had diabetes, blood sugar control or individual differences because of a difference in genetic make-up.

Eligibility criteria:
inclusion criteria: * adolescents ages 12-18 years * tanner stage iii-v * t1dm \> 2 years * hgba1c \ 10 for previous 2 years exclusion criteria: * subjects with known history of hypercholesterolemia or family history of hypercholesterolemia * family history of premature cardiovascular disease * hypertension defined as subjects with blood pressure greater than the 90th percentile for age * anemia defined as hgb \<11.0 g/dl * adhd * congenital heart disease * pituitary tumor * known allergy to ultrasound gel * recent head injury * chromosomal abnormalities
phase 2b multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study to assess the pd response and safety of three dose levels of (pb1023) injection following 20 weeks of weekly sc dosing in adults with t2dm

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: the primary objective of this study is to define the dose response of glymera as measured as the change from baseline in hemoglobin a1c (hba1c) following 20 weeks of once-weekly dosing. secondary objectives: the secondary objectives are to: * describe incidence, severity, and duration of reported gastrointestinal side effects of glymera compared to active comparator; * compare change from baseline in hba1c following 20 weeks of dosing compared to placebo and active comparator; * compare change from baseline in fasting plasma glucose (fpg) following 20 weeks of dosing compared to placebo and active comparator; * describe the frequencies of adverse events in the treatment groups; and * describe the above endpoints for the following subgroups of subjects according to baseline type 2 diabetes mellitus (t2dm) therapy: diet and exercise only, metformin only, sulfonylurea only, or metformin and sulfonylurea combination therapy.


Eligibility criteria:
inclusion criteria: * male and female subjects 18 to 75 years of age, inclusive; * body mass index ≤45 kg/m2; * diagnosed with t2dm with hba1c of ≥7.0% and ≤11.0% and treated with diet and exercise alone, or with stable doses of metformin alone, sulfonylurea alone or metformin and sulfonylurea. exclusion criteria: * currently taking or have taken within the last 6 months non-oral antihyperglycemic agents (eg, insulin, byetta®, bydureon®, or victoza). short-term use of insulin within this period will not be cause for exclusion if insulin was used during the treatment of an acute intercurrent illness; * known allergy to or serious adverse effect caused by an approved or investigational glucagon-like peptide-1 (glp-1) receptor analog/agonist; * unstable cardiovascular disease; * history of weight loss surgery or other gastrointestinal surgical procedures that could possibly interfere with the mechanism of action of glp-1 receptor agonists; * based on contraindications/warnings identified with other glp-1 receptor agonists, subjects will be excluded if they have: history, symptoms, or signs of pancreatitis or severe gastrointestinal disease (ie, gastroparesis) or personal or family history of medullary thyroid tumors or history of multiple endocrine neoplasia syndrome type 2; * clinically significant renal and/or hepatic dysfunction; * pregnant or lactating female subjects.
fetal copeptin after oxytocin challenge test

Conditions: Pregnancy

Summary: the relationship of uterine contractions on fetal copeptin levels in umbilical cord blood is studied.

background: vaginal delivery evokes a dramatic surge in stress hormones facilitating the transition of the infant to extra-uterine life. infants born by elective cesarean section (c-section) are known to have a higher risk for compromised birth adaptation. labor is vital for vaginal delivery and triggers fetal stress hormone release. fetal plasma copeptin, a surrogate marker of arginine vasopressin, has been found to be 100 to 1000-fold increased after vaginal delivery as compared to elective c-section. however, the relationship of labor intensity and fetal stress hormone release is largely unknown. objective: the purpose of this study is to determine fetal copeptin in newborns delivered by c-section to mothers who had an oxytocin challenge test (oct) just prior to birth as compared to those without oct. protocol: pregnant women at term are eligible to participate if no uterine contractions are reported within the last 24 hours and no contractions are recorded in cardiotocogram over 30 minutes. further inclusion and exclusion criteria see below. after written informed consent, all participants get an infusion line and participants receive oct or placebo. the oct is standardized as follows: 5 ie syntocinon (oxytocin) in 500 ml ringer, infusion rate begins with 12 ml/h and is increased by steps of additional 12 ml/h until three contractions within ten minutes are recorded. subsequently, infusion is stopped. the placebo is ringer infusion without syntocinon. c-section is done about 1 to 3 hours after oct or placebo and arterial umbilical cord blood is collected at birth. maternal and newborn data are recorded within the first few days after birth, including maternal blood loss, neonatal adaptation, and postnatal weight loss.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * gestational age more than 36 weeks * no contractions reported within the last 24 hours * no contractions recorded by 30 min cardiotocogram prior to oxytocin challenge test exclusion criteria: * all contraindications for labor, including placenta praevia * serious fetal malformations * anhydramnios * oligohydramnios * iugr \< 5. percentile * presence of any contractions * suspicious or pathological fetal heart rate tracing (cardiotocogram) * any clinical or biochemical signs of maternal infection * breech presentation * more than 1 c-section in history

Keywords: c-section
safety and pharmacokinetics of multiple dose of yc-6 in healthy subjects

Conditions: Ischemic Stroke

Summary: the study is designed to determine the safety, tolerability, and pharmacokinetics in healthy subjects with multiple intravenous administration of the neuroprotectant yc-6 compared to placebo.

tpa administration within 3-4.5 hours after stroke onset has been the only approved therapy and thus no more than 7% of acute ischemic stroke (ais) victims worldwide benefited from tpa. a neuroprotectant, yc-6, showed therapeutic effects in preclinical animal models of ais, indicating its potential as alternative or combined treatment against human ais. this randomized, double-blind, placebo-controlled clinical trial is to explore safety and tolerability in healthy chinese adult volunteers with dose-escalating intravenous infusion of yc-6 for 7 consecutive days. 6 subjects for yc-6 and 2 for placebo will be allocated in each level. blood and urine samples of each subject will be used in determination of pharmacokinetic properties of the investigational drug.

Eligibility criteria:
inclusion criteria: 1. 18\~55 years old healthy subjects 2. bw ≥ 50 kg, bmi 18\~28 kg/m² 3. signed the informed consent from to participate voluntarily and to comply with the trial requirements exclusion criteria: 1. history of clinically significant cardiovascular, hepatic, renal, gastrointestinal, hematologic diseases 2. clinically significant abnormality evidenced from detailed physical examination, 12-lead ecg, biochemistry, hematology, and routine urine analysis 3. glomerular filtration rate (gfr) \< 80 ml/min 4. any medication within 2 weeks before the first administration in this study 5. history of clinically significant allergy and hypersensitivity 6. hepatitis b or c, syphilis, or hiv infection on serological examination 7. history of alcoholic addiction or drug abuse within a year before this study 8. failing of smoking and drunk cessation (breath carbon monoxide test \> 7 ppm) during this study 9. participated in any drug trial within 3 months before this study 10. donated blood or blood product ≥ 400 ml or 2 units within 3 months before this study 11. dissented to avoid intake of tobacco, alcohol, or caffeine, and strenuous exercise or any behavior that would affect the adme of yc-6 12. pregnant or breast-feeding women 13. other subject conditions unsuitable for enrollment in this study