Kornimate/medical-research-clean huggingface dataset:
propofol versus propofol-fentanyl as sedation for lumbar puncture in children with acute leukemia/lymphoma

Conditions: Leukemia; Lymphoma

Summary: the hypothesis of the study is that propofol-fentanyl sedation for lumbar punctures in children with acute leukemia/lymphoma results in fewer adverse events than propofol sedation alone. secondary hypotheses state that propofol-fentanyl sedation results in a better sedation induction, recovery profile and is preferred by patients/families. the study is a double blind, randomized, placebo controlled crossover study. following the induction phase of chemotherapy, children will be randomized in a crossover manner to receive either fentanyl-propofol or propofol-placebo for future lumbar punctures. patients will be studied on two separate occasions, once with propofol-placebo (normal saline) and once with propofol-fentanyl. children will be monitored continuously by pulse oximetry, electrocardiogram (ecg) and direct nursing and physician observation during the sedation in accordance with the university of wisconsin (uw) pediatric policy and procedure. propofol will be titrated to a children's hospital of eastern ontario pain scale (cheops) score of ≤ 7 for all children. oxygen saturation, respiratory rate, heart rate and blood pressure will be recorded every 3 minutes by a study investigator during sedation.


Eligibility criteria:
inclusion criteria: * children ages 2 years to 18 years with acute leukemia/lymphoma cared for by physicians in the division of hematology/oncology in the department of pediatrics and receiving sedation for diagnostic/therapeutic lumbar punctures (lps) in the uw pediatric sedation program * enrollment will occur after the induction phase of chemotherapy. exclusion criteria: * american society of anesthesiology score ≥ 3 * cardiorespiratory instability * allergy to propofol or its components * age less than 2 years * patients receiving other sedative analgesics * patients with an oxygen requirement

Keywords: pediatric acute leukemia/lymphoma
wheal and flare reaction during 24 hours in allergic volunteers.

Conditions: Allergy

Summary: compare the activity of 5 mg levocetirizine and 5 mg desloratadine on allergen-induced wheal and flare reaction.


Eligibility criteria:
inclusion criteria: * male and female allergic volunteers: diagnosed allergy based on medical history and on positivity to skin tests to at least one of the standardized allergen including grass pollens, tree pollens, house dust mites, cat and dog dander and with a positive rast for the specific selected allergen ≥ class 2 exclusion criteria: * pregnancy or lactating females, or females with childbearing potential without reliable contraception * history or presence of any chronic or acute illness or disorder capable of altering the absorption, metabolism or elimination of drugs, or constituting a risk factor when taking the trial medication * heavy caffeine drinker (\> 5 cups of coffee, tea, cola, etc ... per day) * any drug treatment, including prescribed or non-prescription medicines (except hormonal contraceptives or post-menopausal hormonal replacement therapy for females and occasional use of paracetamol not exceeding 2 g/day with a maximum dose of 10 g per 14 days), taken from 14 days before study drug administration; the wash-out period after intake of systemic corticosteroids is at least 4 weeks * known allergy/intolerance to the study drug or any medicine chemically related to study drug or its excipients (lactose, cellulose...) * participation in another clinical trial, blood donation or significant blood loss (\> 450 ml) less than 12 weeks before the study drug administration * skin irritant or 48 hours uv exposure before each visit * immunotherapy received during the current year * any clinical conditions that, in the opinion of the investigator, would make the subject unsuitable for the trial

Keywords: levocetirizine wheal and flare allergic
study bronchoalveolar lavage fluid driven pathogenic diagnosis of lower respiratory tract infections

Conditions: Lower Respiratory Tract Infections

Summary: comparison of microbiological yield from bronchoalveolar lavage fluid (balf) for the two common-used volume bronchoalveolar lavages(60ml and 120ml)in patients with different types of lower respiratory tract infection. assessment of the safety of two common-used volume bronchoalveolar lavages(60ml and 120ml), including the incidence of hospital-acquired pneumonia within 14 days after bronchoscopy, and other bronchoalveolar lavage related adverse events.

the morbidity and mortality of lower respiratory tract infection gradually increased in recent years, but the etiological diagnosis rate is still low. quickly identifying the pathogenic bacteria and the corresponding antimicrobial therapy treatment is particularly important. fibrotic bronchoscopy combined with bronchoalveolar lavage (bal) has become a routine diagnostic tool for pulmonary infections in immunocompromised patients. the correct operation of bronchoalveolar lavage and normalization of bronchoalveolar lavage fluid is a prerequisite for the exact results of the pathogen of balf. american thoracic society recommended amount of 100-300ml of saline solution was instilled into the distal bronchial tree in the diagnosis of interstitial lung diseases. but there is no standard of lavage fluid volume in the etiological diagnosis of lower respiratory tract infections, ranging from 60ml to 250ml ever reported in literature. less lavage volume would be more safer in patients with lower respiratory tract infections. the investigators hypothesize that microbiological yield would be no significant difference in patients with low volume （60ml) compared with large volume (120ml). the purpose of this study is to explore a more effective and safer way of bronchoalveolar lavage in lower respiratory tract infection patients, and determine the pathogenic distribution among them.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of lower respiratory infection 2. indication for bronchoalveolar lavage. exclusion criteria: 1. noninfectious pulmonary infiltration 2. contraindication of bronchoscopy： severe heart or pulmonary dysfunction recent occurrence of myocardial infarction unstable angina pectoris severe coagulation disorders (dic), massive hemoptysis gastrointestinal bleeding thrombocytopenia (\<50\*109/l) severe superior vena cava obstruction syndrome aortic aneurysm multiple pulmonary bulla extreme exhaustion 3. diagnosed or highly suspected of tuberculosis infection 4. researchers think that can not be entered into the group.

Keywords: bronchoalveolar lavage lower respiratory tract infections
efficacy and safety of js002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia

Conditions: Primary Hypercholesterolaemia and Mixed Dyslipidemia

Summary: js002 is a recombinant humanized anti-pcsk9 monoclonal antibody. this is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, pk/pd profile, immunogenicity as well as complete delivery of auto-injector by patients of js002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia. in this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to js002 or placebo 150/450 mg group in a 2:1:2:1 ratio).a screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. age 18\~80 years old 3. subject who has not achieve ldl-c goal as categorized by their cv risk at screening 4. fasting tg≤4.5mmol/l by central laboratory at screening 5. statin intolerance subject must have a history of statin intolerance as evidenced exclusion criteria: 1. history of hemorrhagic stroke 2. nyha iii or iv heart failure, or known lvef\< 30% within 1 year before randomization 3. uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, within 90 days prior to randomization 4. myocardial infarction, unstable angina, percutaneous coronary intervention (pci), coronary artery bypass graft (cabg) or stroke, deep vein thrombosis or pulmonary embolism within 90 days prior to randomization 5. planned cardiac surgery or revascularization 6. uncontrolled hypertension defined as sitting systolic blood pressure(sbp) \> 160 mmhg or diastolic bp (dbp) \> 100 mmhg 7. type 1 diabetes, poorly controlled type 2 diabetes (hba1c \> 8%), newly diagnosed type 2 diabetes (within 90 days of randomization) 8. others factors not suitable for participation judged by pi
maintenance of anaesthesia with sevoflurane versus propofol and the occurrence of postoperative headache.

Conditions: Headache

Summary: postoperative headache is a major issue after general anaesthesia and surgery. the aim of this study is to investigate the possible difference in the occurrence of postoperative headache when general anaesthesia is maintained with propofol, which is supposed to have protective effects on migraine patients, versus sevoflurane.

postoperative headache is a major issue after general anaesthesia and surgery. the aim of this study is to investigate the possible difference in the occurrence of postoperative headache when general anaesthesia is maintained with propofol, versus sevoflurane. propofol acts throught a gaba, and is known to have a therapeutic effect on migraine patients with accute attacts. however, its role on postoperative headache has not been studied, when used for maintainance of anaesthesia, this study aims to investigate the occurrence of headache after anaesthesia and surgery, when patients receive randomly two different anaesthetics: propofol and sevoflurane.

Eligibility criteria:
inclusion criteria: * asa i-iii * scheduled operation under general anaesthesia * operations \<4 hours * minorgynaecological operatios (leiomyomectomy) * hernia repair * arthroscopic procedurs * minor orthopaedic operations without the use of tourniquet or cement * saphenectomy * minor urologic operations * minor other operations of general surgery exclusion criteria: * age \ 65 years old * asa\>iii * diseases of the central nervous system (ie parkinsons's disease, multiple sclerosis, previous ischaemic attack, hydrocephalus, seizure disorder, etc) * psychosis under medication * cognitive impairement or/and inability to fill in the questionaires * allergy or contraindication to the study protocol included drugs * operations of more than 4 hours duration * head and neck procedures, procedures with neck extension (eg thyroidectomy), ent procedures * renal impairement * hepatic impairement * patient refusal
predicting cancer risk with digital and molecular markers

Conditions: Breast Cancer; Lung Cancer; Colorectal Cancer; Gynecologic Cancer

Summary: the goal of this study is to identify new markers to predict the risk of developing cancer, primarily breast cancer. for this purpose, researchers will compare data obtained from cancer patients and healthy individuals. if characteristic differences are identified, e.g. in biomarkers, life style or family history, this may indicate a person's increased risk of developing cancer.


Eligibility criteria:
inclusion criteria: 1. biological adult (at least 18 years old) women 2. written informed consent for study participation and processing of personal data 3. own smartphone that can run the baypass mobile application and willingness to use said smartphone for study purposes additional inclusion criterion for case group: 4. pre-existing or current diagnosis of at least one of the following oncological diseases: breast cancer, lung cancer, colorectal cancer, gynecologic cancer (incl. ovarian cancer, endometrial cancer, cervical cancer, fallopian tube cancer, vaginal cancer and vulvar cancer) exclusion criteria: 1. known infection with hiv (human immunodeficiency virus), hepa (hepatitis a), hepb (hepatitis b), hepc (hepatitis c) or active sars-cov2 (severe acute respiratory syndrome coronavirus type 2) infection 2. acute severe or potentially life-threatening illness, except those specified in inclusion criterion #4
colony-stimulating factor-1 (csf-1) and other cytokines in human endometrial carcinogenesis

Conditions: Uterine Neoplasms; Endometrial Neoplasms

Summary: the purposes of this study are the following: 1. to further characterize and quantify both csf-1 and colony-stimulating factor-1 receptor (csf-1r) expression from additional tumor specimens, specifically, tumors of high grade and from metastatic sites. 2. to assay using enzyme-linked immunosorbent assay (elisa) sandwich monoclonal antibody methodology, csf-1 expression in the peritoneal fluid and blood from patients with endometrial adenocarcinomas. 3. using immunohistochemistry, to evaluate the presence of staining for csf-1 and csf-1r from additional patients with endometrial adenocarcinomas, especially of high grades and from metastatic sites. 4. to determine the extent of cytokine, specifically csf-1, but also interleukin-1 (il-1), il-6, and granulocyte-macrophage colony-stimulating factor (gm-csf), production, in endometrial carcinoma cells in primary cell culture. 5. to determine the responsiveness of epithelial cells on estrogen and antiestrogen binding, to determine if csf-1 production is mediated, in these cells, by estrogen receptor binding, or alternative pathways of intracellular/cell-cell signal transduction. 6. the ultimate objective of these experiments is to characterize csf-1 expression from benign and tumor cells in order to identify steps in the csf-1 activated signalling pathways that may represent potential targets for therapy.

these experiments, taken together, should critically determine if there is a role for the csf-1/ c-fms autocrine, endocrine, or paracrine loop in the progression of endometrial adenocarcinoma. if so, alterations in this loop may provide novel medical therapies for this disease. additionally, these experiments will determine which are the predominant cytokines expressed in these tumors, and will help the investigators to determine the role, if any, these cytokines play in cancer cell growth and proliferation in relationship with each other and within and outside of the estrogen-mediated pathways.

Eligibility criteria:
inclusion criteria: * all patients undergoing hysterectomy, or who have endometrial cancer, and are under routine surveillance. * patients may have received prior hormonal, cytotoxic chemotherapy, irradiation or surgical therapy. * healthy post-menopausal and peri-menopausal women. * a consent form must be signed by the patient prior to study entry. exclusion criteria: * patients who do not have primary uterine corpus tumors. * patients with less than one gram of tumor tissue available to procurement.

Keywords: corpus uteri endometrium cancer
a study of therapeutic amplitude-modulated electromagnetic fields in advanced tumors

Conditions: Cancer; Brain Tumor

Summary: in vitro studies suggest that low levels of amplitude-modulated electromagnetic fields may modify cell growth. we have identified specific frequencies that may block cancer cell growth. we have developed a device delivering low levels of amplitude-modulated electromagnetic fields. the device is connected to a spoon-like coupler, which is placed in the patient's mouth during treatment. we will conduct a feasibility study consisting of three daily ambulatory treatments until disease progression.

background: in vitro studies suggest that low levels of amplitude-modulated electromagnetic fields may modify cell growth. we have identified specific frequencies that may block cancer cell growth. we have developed a portable and programmable device delivering low levels of amplitude-modulated electromagnetic fields. the device is connected to a spoon-like coupler, which is placed in the patient's mouth during treatment. methods: we will conducted a feasibility study consisting of three daily treatments. all patients with advanced solid tumors and measurable disease will be eligible, irrespective of prior treatments. patients will be assessed with laboratory exams (complete blood count, comprehensive profile, tumor markers), imaging studies every other month for the first six months, every third month thereafter.

Eligibility criteria:
inclusion criteria: * advanced tumor that is either metastatic or inoperable exclusion criteria: * pregnancy, * other simultaneous anticancer therapies, * ecog performance status less than 3

Keywords: cancer electromagnetic fields treatment
external trigeminal nerve stimulation for drug resistent epilepsy

Conditions: Seizure Disorder

Summary: the purpose of this study is to evaluate the tolerability and safety of the neurosigma etns system.

this study evaluates the safety and tolerability of the neurosigma etns system for the treatment of drug resistent partial seizures. up to 20 subjects, ages 18 - 75, with partial epilepsy will be enrolled in an acute 4-week tolerability study at olive view/ucla medical center ....... enrolled subjects will be asked to maintain an accurate seizure calendar, and will be seen at the initial visit, then at two and four weeks.......

Eligibility criteria:
inclusion criteria: * age 18-65 * partial onset seizures (complex partial or secondary generalized tonic-clonic) * at least one seizure every three months * no serious or progressive medical or psychiatric illness * at least one complex partial or generalized tonic-clonic seizure in the last three months * mri or eeg consistent with localization-related or partial epilepsy * exposure to at least two anti-epileptic drugs at adequate doses * concurrent use of at least one anti-epileptic drug at adequate doses * no change in anti-epileptic drug dose for at least 30 days prior to study enrollment exclusion criteria: * vagus nerve stimulation (vns) * history of non-epileptic seizures * inability to maintain accurate seizure calendars (self or caregiver) * frequent use of benzodiazepines for seizure clusters defined as greater that four times per month * history of facial pain or trigeminal neuralgia * pregnancy

Keywords: epilepsy drug resistent epilepsy partial onset seizures trigeminal nerve stimulation neuromodulation
spark: safety study of pradaxa in atrial fibrillation patients by regulatory requirement of korea

Conditions: Atrial Fibrillation

Summary: this is a prospective, non-interventional, open-label, multi-centre study. it will provide additional safety information of pradaxa in korean patients with non-valvular af in clinical settings.

study design: regulatory post marketed surveillance study

Eligibility criteria:
inclusion criteria: * age \>= 18 years at enrollment * patients who have been started on pradaxa in accordance with the approved label in korea * patients who have signed on the data release consent form exclusion criteria: * patients with previous exposure to pradaxa * clinically significant bleeding * increased risk of bleeding due to following diseases; * recent gastrointestinal ulceration * recent intracranial or intracerebral bleeding history * intraspinal or intracerebral vascular abnormalities * recent brain, spinal or ophthalmic surgery * recent brain or spinal injury * known or suspected oesophageal varices * arteriovenous malformations * vascular aneurysms * presence of malignant neoplasms at high risk of bleeding * concomitant treatment with any other anticoagulants e.g. unfractionated heparin (ufh), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under the circumstances of switching therapy to or from pradaxa or when ufh is given at doses necessary to maintain an open central venous or arterial catheter * severe renal impairment (crcl \< 30ml/min) * concomitant treatment with oral ketoconazole or dronedarone * patients hypersensitive to dabigatran or dabigatran etexilate or to any ingredient in the formulation * prosthetic heart valve replacement * no creatinine clearance collected within at least one year prior to enrollment * current participation in other clinical trials
effect of aerobic exercise and mediterranean diet on obese patients

Conditions: Obesity

Summary: all study group patients performed aerobic exercise on a treadmill. approved by the american college of sports medicine. both groups received a mediterranean diet for 12 weeks tailored according to patients' caloric needs

all study group patients performed aerobic exercise on a treadmill approved by the american college of sports medicine. the program started with a warming-up phase through walking on a treadmill for 3-5 minutes at a slow speed. then, 10-30 minutes of aerobic exercise training with moderate intensity (60-70% of maximum heart rate) and 10 minutes of cooling down with low speed and without inclination. participants had 3 sessions/week for 3 months with close supervision of a physical therapist. both groups received a mediterranean diet for 12 weeks tailored to patients' caloric needs. they received instructions about the consumption of olive oil as added lipid, the consumption of nuts and olives as snacks, daily high consumption of vegetables, fruits, and whole grains, dairy products, bi-weekly consumption of legumes, bi-weekly consumption of fish, and monthly consumption of meat. the main beneficial components of the mediterranean diet are monounsaturated fats such as oleic acid in olive oil, polyunsaturated fats such as omega-3, high amounts of flavonoids and antioxidants found in fruits and vegetables, and high amounts of fiber found mainly in foods with a low glycemic index

Eligibility criteria:
inclusion criteria: * obese patients with bmi ranged from 30-39.9 kg/m 2. * their age was from 35 to 45 years old. * both genders. * stable vital signs (blood pressure, respiratory rate and temperature) * abdominal obesity measurements according to american heart association) * obese patients have one or more abnormal value of lipids profile. * all patients with sedentary life style. * all patients had insulin resistance exclusion criteria: * rheumatic, neurologic, cardiovascular, respiratory, renal, lung problems, malignant tumors, and undiagnosed fever, which would prevent them from participating in aerobic exercises. * knee injury or knee surgery during the past six month or having a history of joint replacement or fracture or hereditary or acquired musculoskeletal disorders in lower limb. * major vision disorders. * drugs that would affect metabolism or balance. * assistive devices for walking. * pregnancy or breast feeding, and post-partum 12 months. * abdominal or rectal anus surgery.

Keywords: aerobic exercise inflammatory markers
safety and efficacy trial of aczone (dapsone) gel, 7.5% in 9 to 11 year-old patients with acne vulgaris

Conditions: Acne Vulgaris

Summary: this study will evaluate the safety, tolerability, pharmacokinetics (pk) and efficacy of aczone gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with acne vulgaris.


Eligibility criteria:
inclusion criteria: -has acne vulgaris on the face, including the nose, with 20 to 100 total lesions (noninflammatory and/or inflammatory). exclusion criteria: * has uncontrolled systemic disease(s) * has severe cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne) * has used topical dapsone within 1 month prior to the screening * has used oral dapsone within 2 months prior to screening.