Kornimate/medical-research-clean huggingface dataset:
blopress tablets specified drug-use survey "hypertension: survey on patients with metabolic syndrome"

Conditions: Hypertension

Summary: the purpose of this survey is designed to investigate the treatment status of hypertensive patient with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (blopress tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner.

this survey was designed to investigate the treatment status of hypertensive patients with metabolic syndrome-related risk factors treated with candesartan cilexetil tablets (blopress tablets), as well as to assess relationships between risk factors (example, visceral fat accumulation) and the incidence of cerebrovascular/cardiovascular events in an exploratory manner. for adults, 4-8 mg of candesartan cilexetil is typically administered orally once daily. the dose is increased up to 12 mg, as necessary. for patients with complications of renal damage, however, administration of candesartan cilexetil should be started at 2 mg once daily, and, as necessary, the dose increased up to 8 mg.

Eligibility criteria:
inclusion criteria: hypertensive patients with at least one of the following risk factors: * waist circumference greater than or equal to (≥) 85 centimeter (cm) for male and ≥ 90 cm for female * fasting triglyceride level ≥ 150 milligram per deciliter (mg/dl) * high-density lipoprotein (hdl) cholesterol level less than (\<) 40 mg/dl * fasting blood glucose level ≥ 110 mg/dl * body-mass index (bmi) ≥ 25.0 \* patients currently taking medications for hypertriglyceridemia, hypo-hdl-cholesterolemia, or diabetes mellitus are also regarded as meeting the criteria for inclusion in the surveillance exclusion criteria: hypertensive patients who meet all of the following conditions (\[1\] to \[3\]): 1. patients receiving continuous therapy with blopress tablets 2. patients aged \< 20 years or ≥ 75 years 3. patients with a history of cerebrovascular or coronary artery disease within 6 months before the start of the surveillance

Keywords: pharmacological therapy
hormone and sleep response to antidepressant treatment in adolescents and adults with depression

Conditions: Depression

Summary: this study will determine whether there are age-related differences in the body systems controlling sleep and stress hormone patterns. this study will also determine whether the differences in sleep and hormone patterns between depressed adolescents and adults are associated with differences in their response to antidepressant treatment.

adolescent depression is a serious public health concern that may lead to functional disability and death. the problems associated with the condition may continue into adulthood; therefore, early identification and effective treatment of adolescent depression is critical. studies indicate that depressed adolescents experience greater variations in sleep and hormone patterns than depressed adults. these variations may influence responses to antidepressant treatment. this study will examine the mechanisms underlying developmental differences in sleep and hormone patterns to develop a strategy for identifying adolescents and adults who could benefit from antidepressant treatment. this study will last approximately 10 weeks. at study start, participants will wear an activity monitor on their wrist and keep track of their nightly sleep schedule to establish baseline measures. this will continue for 2 weeks. during the second week of wearing this watch the participant will be asked to come in for a sleep study. this study will consist of two initial nights in the sleep lab and then two more nights in the lab a week later. participants will be able to leave during the day. upon completing the sleep assessment, participants will receive bupropion twice daily for 8 weeks. upon completion of this 8-week treatment, participants will be interviewed to assess the effectiveness of the treatment. one follow-up meeting will occur 6 months post-treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder and/or dysthymic disorder exclusion criteria: * current treatment with antidepressant drugs * major medical illness * diagnosis of anorexia nervosa or manic-depressive illness * pregnancy

Keywords: sleep, rem antidepressant adolescent cortisol
treatment response assessment maps to delineate necrosis from tumor after stereotactic radiation in brain metastases

Conditions: Brain Tumor

Summary: this research study is investigating the value of an imaging study of the brain called an mri (which stands for magnetic resonance imaging), utilized in unique way, to delineate whether the tumor has recurred or whether radiation changes have occurred after a brain metastasis treated with focused radiation has enlarged.

this research study is a phase ii clinical trial. in this research study, the investigators are utilizing mris of the brain with additional post-imaging processing (called treatment response assessment maps or trams) to try to delineate tumor recurrence from radiation changes. the investigators hope to understand whether such a test may allow future patients to avoid resection entirely.

Eligibility criteria:
inclusion criteria: * participants must have a histologically or cytologically confirmed solid malignancy of extracranial origin and radiographic evidence of at least one brain metastasis for which stereotactic radiation was utilized in the past. patients with intracranial pathologic confirmation of a malignancy which originated extracranially but for which extracranial disease has not been biopsied are eligible. * participants must have an enlarging lesion in the brain at least 4 months after prior stereotactic radiation to the same site for which neurosurgical resection is planned as routine standard of care. * participants must be age 18 years or older. * participants must be willing to undergo study procedures. * the effects of gadolinium / other mri-based contrast agents on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. * participants must possess the ability to understand and the willingness to sign a written informed consent document via ink on paper or via an electronic signature medium such as adobe sign. exclusion criteria: * participants who have a contraindication to mri (e.g. non compatible implanted metallic device for which mri is absolutely contraindicated). * participants who have chronic kidney disease stage iv-v or end stage renal disease. * participants with a history of anaphylactic reactions to gadolinium. * pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. similarly, breastfeeding women will be excluded from this study.

Keywords: brain tumor
assessment of thoracic echography for pleuroparenchymatous anomaly diagnosis complicating bronchiolitis: bronchioius

Conditions: Bronchiolitis

Summary: the diagnosis of bronchiolitis, the most frequent lung infectious disease in infancy, is based on clinical examination. chest x-ray is proposed when a lung parenchymal condensation is suspected. chest ultrasound is supposed to be a useful tool in the diagnosis of these complication but is poorly evaluated. we aim to compare chest x-ray and chest ultrasound for the diagnosis of parenchymal condensation in infant with bronchiolitis.

900 to 1000 children are admitted each year for bronchiolitis in the pediatric emergency department of the toulouse children hospital. the diagnosis is based on clinical examination, but in some cases furthers examinations such as chest x-ray are necessary in order to look for a parenchymal condensation. even if french recommendations do not place chest ultrasound in the care pathway to date, many recent studies show the usefulness, rapidity and reliability of ultrasound in parenchymal abnormalities. but regarding the bronchiolitis, few studies are available and including limited numbers of patients. in addition, the reduction of irradiation is a main goal, especially in children. we propose to performed a chest ultrasound in infants (\<24 months) admitted for bronchiolitis with an available chest x-ray, in order to compare the performance of both examinations (x-ray and ultrasound) for the diagnosis of parenchymal condensation. besides, to correlate initial chest ultrasound results and clinical evolution, parents will be contacted by phone 1 month after inclusion. primary outcome: the primary outcome is the sensitivity and specificity values of chest ultrasound for the diagnosis of parenchymal condensations diagnosed by chest x-ray. positive and negative predictive values will also be estimated. this outcome is evaluated at the first visit (t0). secondary outcomes: * to describe chest x-ray and ultrasound abnormalities in bronchiolitis. * to evaluate the performance of chest ultrasound to distinguish retractile and non-retractile opacities complicating bronchiolitis. * to study the correlation between clinical evolution at 1-month (malaise, place and duration of hospitalization, re-hospitalization, oxygen therapy, antibiotic therapy) and chest ultrasound results. follow-up parameters are recorded during a telephone call 1 month after inclusion. study design : it is a longitudinal, monocentric and prospective study with the aim to evaluate a diagnostic examination.

Eligibility criteria:
inclusion criteria: * two years old patient at emergency hospital (chu-toulouse) for bronchiolitis and performing of thoracic radiology * informed consent formed to sign by family before the exam and the evidence of social security regime affiliation. exclusion criteria: * patient with cardiopulmonary disease or underlying immunosuppression

Keywords: bronchiolitis parenchymal condensation chest x-ray chest ultrasound
cranial blocks for postoperative anesthesia

Conditions: Craniotomy Surgery

Summary: this study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies.

objective: to assess the effectiveness of analgesia by scalp nerve block with various agents in the first 72 hours following elective craniotomy. the investigators will employ a randomized, single-blinded, prospective study design. participants will be randomized 1:1:1 into one of three treatment groups: bupivacaine, liposomal bupivacaine, and saline.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * need for elective supratentorial craniotomy * preoperative gcs \> 13 exclusion criteria: * preoperative gcs ≤ 13 * child (\<18 years of age) * inability to understand or use the visual analog scale (vas) * proven or suspected allergy to local anesthetics * craniotomy incision extending beyond the field of the block * patients chronically (more than 2 wk) treated with narcotic medications * previous scalp incision * bilateral craniotomies * allergies to local anesthetics * gcs verbal score \< 4 after extubation * patients whose surgeries extend past 6 hours (will be placed on standard of care and removed from study) * patients currently on ergot-type oxytoxic drugs, maois, or certain antidepressants * lactating mothers

Keywords: craniotomy
effects of interleukin-1 receptor antagonism on hyperandrogenemia in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: a prospective, interventional, open-label, single-arm, proof-of-concept study: 18 women with polycystic ovary syndrome (pcos) will be treated with 100 mg of anakinra/kineret® for 4 weeks. 1 week after last injection patients will have a follow-up and a dexamethasone visit after a dexamethasone suppression test. goal of this study is to investigate the effect of the interleukin 1( il-1) receptor antagonist anakinra/kineret® on laboratory and clinical features in women with pcos.


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * premenopausal women aged 18 years or older * onset of menarche ≥5 years ago * diagnosis of pcos defined by the rotterdam criteria * high sensitivity c-reactive protein level ≥1 mg/l * follicular phase of menstrual cycle as evident by * serum estradiol level \<200 pmol/l and * serum progesterone level \<8 ng/ml * willingness to use non-hormonal contraceptive measures adequate to prevent becoming pregnant during the study exclusion criteria: * intake of any testosterone level modifying drugs in the 8 weeks prior to study inclusion, * contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to anakinra/kineret, * women who are pregnant or breast feeding, * female participants who are ovariectomized or hysterectomised or post-menopausal * known or suspected non-compliance, drug or alcohol abuse, * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * participation in another study with investigational drug within the 30 days preceding and during the present study, * previous enrolment into the current study, * enrolment of the investigator, his/her family members, employees and other dependent persons, * clinical signs of infection in the week before inclusion or history of a severe infection during the last 2 months, * potentially severe immunosuppression or intake of other immunosuppressive drugs * severe hematologic disease * other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, active carcinoma), * history of or suspected tuberculosis and/or hepatitis b/c

Keywords: interleukin-1 receptor antagonism kineret/anakinra testosteron hyperandrogenemia androstenedione
a long-term trial of opc-34712 in patients with schizophrenia

Conditions: Schizophrenia

Summary: to investigate the safety and efficacy of long-term administration of opc-34712 in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * patients age 18 years or older (at time of informed consent) diagnosed with schizophrenia based on dsm-iv-tr diagnostic criteria * outpatients who are receiving an oral antipsychotic treatment (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with opc-34712 is considered feasible exclusion criteria: * female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product * patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current dsm-iv-tr axis ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
warming efficiency of warm compresses versus blephasteam® in eyelid therapy

Conditions: Eyelid Diseases

Summary: the eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids phase i, prospective, comparative study, investigator masked , monocentric objectives are to assess and compare the warming and moisture of blephasteam® device versus the warming and moisture of warm and moist compresses. to assess and compare safety on the ocular surface after 10 minutes of blephasteam® application versus after 10 minutes of warm and moist compresses application


Eligibility criteria:
inclusion criteria: * male or female aged from 18 to 80 years old. * healthy volunteers. * for any contact lens wearers, they must be wearing hydrogel contact lenses (worn at least 3 times per week) * normal ocular examination in both eyes.

Keywords: warming goggles
sova ambassadors community setting

Conditions: Depression

Summary: the purpose of this study is to examine participant adherence to intervention feasibility and acceptability of intervention, attention control, and implementation strategy.

a 1:1 pilot randomized controlled trial of the sova peer ambassador program compared to attention control: brief psychoeducational independent assignments (i.e. reading sova articles and responding to open-ended questions without content creation and without peer interaction) (n=40) and evaluate feasibility of implementation strategy.

Eligibility criteria:
inclusion criteria: * ages 14 to 21 can read and understand english has completed 6th grade scores at least 5 or greater on the phq-8 (depression) and/or 5 or greater on gad-7 (anxiety) consistent with at least mild symptoms exclusion criteria: * no access to internet has an intellectual or physical ability which prohibits reading text on the internet (can participate if able to use with assistance, e.g. can use text to speech) no active email account (can participate if plans to create one)

Keywords: adolescent adolescent medicine mental health services ehealth online systems primary healthcare social media social support
the altered immune response to exercise in patients with fibromyalgia before and after a mind-body intervention

Conditions: Fibromyalgia

Summary: the purpose of this study is to compare two different exercise programs to see if there are differences after exercise in fibromyalgia (fm) symptoms and responses from the immune system.


Eligibility criteria:
inclusion criteria for fm patients: * patients with a diagnosis of fm * clearance from patient's physician to participate in a clinical trial * not participating or willing to discontinue fm treatment with trans-cutaneous electrical nerve stimulation, biofeedback, tender-point injections, acupuncture, yoga, and tai chi. exclusion criteria for all participants: * diagnosis of severe psychiatric illness * abuse of alcohol, benzodiazepines, or other drugs * active cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or autoimmune disease (except hashimoto's or graves' disease that has been stable for 3 months before screening) * current systemic infection * active cancer (except basal cell carcinoma); * unstable endocrine disease * severe sleep apnea * prostate enlargement or other genitourinary disorder (male patients) * pregnancy or breastfeeding inclusion criteria for healthy controls: * female * no apparent medical condition that will interfere with participation in the study * not on any medication that will interfere with participation in this study exclusion criteria for healthy controls: * medical or surgical conditions including medication that preclude participation in the study * presence of motor or neuromuscular deficits that may preclude participating in fatigue exercise

Keywords: exercise low intensity exercise pain fatigue sleep problems
cancer stem cells in acute leukemia

Conditions: Acute Leukemia

Summary: descriptive study of acute leukemia patients. bone marrow aspirate or peripheral blood samples will be analyzed by next-generation sequencing for novel gene signatures and variations in transcriptional and epigenetic regulatory elements such as arid5b and sall4 variants.


Eligibility criteria:
inclusion criteria: * newly diagnosed or relapsed acute leukemia (aml or all) * plan to undergo diagnostic bone marrow aspirate or peripheral blood if clinically indicated (i.e. wbc\>50,000 and bone marrow contraindicated) * age 1 month to 30 years * understand and provide informed consent (subject if\>18, legal guardian if\<18) exclusion criteria: * age 0 to 4 weeks * treatment related leukemia or leukemia secondary to mds * situations that would limit compliance with study requirements or ability to willingly give consent
dexmedetomidinine in the prevention of postoperative delirium in the intensive care unit after cardiac surgery

Conditions: Intensive Care Unit Delirium

Summary: this is a prospective, randomized, single blinded, controlled clinical trial designed to compare the clinical effects of sedation with dexmedetomidine versus propofol in patients undergoing cardiac surgery.

the study will include adult patients of both sexes scheduled for elective cardiac surgery with the use of cardiopulmonary bypass (including coronary artery bypass grafting, valve repair/replacement, and combined). the patients included in the study will be randomized in 1:1 ratio using computer generated numbers into two groups. the first group of patients, upon arrival to the intensive care unit will be sedated with continuous dexmedetomidine infusion in doses 0.2-0.7 mcg/kg/h. dexmedetomidine infusion will be discontinued before weaning from mechanical ventilation and extubation. the second group of patients, upon arrival to the intensive care unit will be sedated with continuous propofol infusion in doses 1-2 mg/kg/h. propofol infusion will also be discontinued before weaning from mechanical ventilation and extubation. sedation level will be assessed using richmond agitation and sedation scale (rass) every two hours. postoperative analgesia will be managed according to protocol (opioid analgesics, non-steroid anti-inflammatory drugs, paracetamol), with pain level assessment using visual analog scale (0 - no pain; 10 - unbearable pain). the following data will be registered: age, sex, body mass index (bmi), hemoglobin, heart rate, and lvef. among the postoperative parameters, the following will registered: duration of mechanical ventilation (in hours), extubation time, icu and hospital length of stay (in days), postoperative hemoglobin, blood product transfusion rates, occurrence of atrial fibrillation and assessment of delirium. assessment of delirium will be performed using the confusion assessment method for intensive care unit (cam-icu) every 12 hours during five postoperative days.

Eligibility criteria:
inclusion criteria: * patients undergoing open heart surgery with the use of cardiopulmonary bypass (including coronary artery bypass grafting, valve repair/replacement, and combined) * left ventricular ejection fraction (lvef) \>40%. exclusion criteria: * preoperative atrial fibrillation * previous history of interventionally treated arrhythmias * second and third degree atrioventricular block * bradycardia with heart rate ≤50/min * pacemaker * renal or hepatic insufficiency * emergency procedures * history of serious mental illness, delirium, and severe dementia

Keywords: open heart surgery sedation dexmedetomidine postoperative delirium
the topical niacin skin flush test in first episode psychosis

Conditions: Psychotic Disorders; Schizophrenia

Summary: the purpose of this study is to gather normative data from healthy adults and to determine a sensitive and specific cut-off value for responders and non-responders to the niacin skin flush test in a sample of first episode psychosis patients.


Eligibility criteria:
inclusion criteria: * caucasian * within twelve months of initial dsm iv tr diagnosis of schizophreniform psychosis, schizophrenia, schizoaffective disorder or psychotic disorder nos * outpatient exclusion criteria: * known allergy to study compound (methyl nicotinate, vitamin b3, niacin) * skin conditions (e.g., dermatitis, psoriasis, eczema) * diagnosis or treatment for medical conditions that may affect normal vascular tone (e.g., diabetes, vasculitis, chronic hypertension, etc.) * use of anti-inflammatory, antibiotic, or antihistamine medications within one month prior to study entry * use of supplements like omega 3 fatty acids within 3 months prior to study entry * use of vitamin or nutritional supplement containing a dose of niacin/nicotinic acid above 50 mg/day at study entry

Keywords: diagnostic techniques and procedures sensitivity and specificity skin tests biological markers