Kornimate/medical-research-clean huggingface dataset:
two syringe spinal anesthesia technique for cesarean section: a simple way to achieve more satisfactory block and less hypotension

Conditions: Cesarean Section

Summary: background: poor spinal anaesthesia block is common and is difficult to manage; so a technique to minimize its incidence is advisable. hypotension is the commonest problem with spinal anesthesia. multiple trials to prevent or combat hypotension using positional changes, fluid therapy and the use of vasopressors were tried. however, the drug choice and mode of administration as either bolus or infusion is still a matter of debate. objectives: to compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine. design: a randomized, controlled clinical trial. setting: single medical center from 5/2013 to 10/2014. patients \& methods: 124 parturient scheduled for elective cesarean section (cs) were randomly allocated into two groups, each 62 parturient: group m received spinal anesthesia using 10 mg bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and group s received 25 µg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe. intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was started as fast drip during, and continued after spinal anesthesia. patients were monitored for hemodynamic parameters, time of sensory onset and height of maximum sensory block, lower limb motor blockade was scored using modified bromage scale and the frequency of side effects.


Eligibility criteria:
inclusion criteria: * parturient at full term. * must be elective cesarean section. * must be uncomplicated pregnancy exclusion criteria: * body weight \ 90 kg * height ˂150 cm or \>170 cm. * pre-eclampsia. * any major systemic disease. * contraindication to regional anesthesia. * allergy to used medications.

Keywords: spinal anesthesia
a single-center, open trials to evaluate the safety of freeze-dried group acyw135 meningococcal conjugate vaccine

Conditions: Meningococcal Meningitis

Summary: safety evaluation of freeze-dried group acyw135 meningococcal conjugate vaccine in healthy people above 2-months-old

there are five different age groups(18\~55 years/7\~17 years/1\~6 years/7\~10 months/2 months),each group has 40 people and divided into two subgroups. each subgroup will inject different vaccine(mcv4 4μg,mcv4 8μg).for 7\~10 months\&2 months age groups,there are 2\&3 injection seperately. each injection interval is 1 months. after 7 days observation of 1 dose immunization in group 18-55 years old adults, if there are no serious adverse events associated with vaccines, or severe adverse reactions rate is less than 10%, 7 to 17 years old and 1 to 6 years old age groups will continue to inoculate in order. after the first dose of 7\~10 months group and evaluating safety, 2 months group immunized the first dose. all participants completed the immune procedure, then observed the safety to 30 days after whole immunization. data collection: subjects completed diary card, the researchers collected original data and fill out the case report form for data entry and statistical analysis.

Eligibility criteria:
inclusion criteria: * healthy infants unimmunized group a\&c meningococcal conjugate vaccine or group a meningococcal polysaccharide vaccine which is above 2\~11 months-old, and healthy toddler more than 1-year-old without booster immunization. * the guardian or himself informed consent, and signed the informed consent form; * the guardian and family agreed to abide by the requirements of clinical trial scheme; * participants has no history of immunoglobulin vaccination in the last 2 months / 2 months-old infants has no history of immunoglobulin vaccination after born, there is no history of other live vaccine inoculation before vaccination in 14 days, within 7 days without other inactivated vaccine immunization history; * the axillary temperature \< 37.1 ℃; * 2-months-old group in the age of 61-90 days; * 7-months-old group in the age of 211-300 days; * 1-year-old group in age of one full year of life. exclusion criteria: * have allergies, convulsions, seizures, encephalopathy and psychiatric history or family history; * neomycin, streptomycin and polymyxin b allergies; * with immunodeficiency, immunosuppressant therapy; * history of meningitis; * women in lactation or pregnant; * acute febrile diseases and infectious diseases; * history of labor abnormalities, choking rescue, congenital malformations, developmental disorders or serious chronic disease patients; * had a severe allergic reaction of vaccination in the past; * took oral steroids more than 14 days in last month; * had high fever (axillary temperature≥38.0℃ or higher)in the past three days; * prepare to attend or is in any other drug clinical study; * meningococcal vaccine contraindications and any situation which researchers think that may affect test evaluation.
the effect of prebiotics on the microbiome in irritable bowel syndrome patients: the diet and microbiome study

Conditions: Irritable Bowel Syndrome

Summary: irritable bowel syndrome (ibs) is a chronic gastrointestinal illness of unknown cause whose symptoms include abdominal pain, bloating and altered bowel pattern. diet has been shown to influence the bacteria gut interaction. our aim is to determine if components of the diet affect ibs symptoms by changing the bacteria gut interaction. in particular, we will measure whether after being on a diet high or low on certain factors there is a change in the timing and amount of hydrogen and methane produced by bacteria digesting lactulose and on ibs symptom severity.


Eligibility criteria:
inclusion criteria: * meet rome iii criteria for ibs * willing to undergo dietary intervention exclusion criteria: * history of gastric, small bowel or colonic surgery * history of inflammatory bowel disease * celiac disease * unable to come off following medications: antibiotics, laxatives, narcotics, sedatives * on a pre specified diet * pregnant

Keywords: diet
ankle trauma diagnostic value of ultrasound compared to standard radiography in the detection of fractures

Conditions: Fractures Bone

Summary: to investigate the diagnostic value of ultrasound performed by a lay experimenter compared to standard radiographic imaging (or standard x-ray) in the detection of fractures in patients with closed acute ankle trauma and positive ottawa ankle rules

selection of patients is according to the criteria detailed below. if the patient is deemed eligible for the study, he will be asked to read and sign the informed consent. besides standard history taking, physical examination and radiographic imaging, a standardized ultrasound examination of the ankle joint will be performed by a lay experimenter. care will be provided by the attending physician and, according to "standard of care", treatment decisions will be based on history taking, physical examination and conventional ankle x-ray series. sonographic results will not be used for this purpose. all ankle x-ray series will be reviewed by a senior resident radiologist.

Eligibility criteria:
inclusion criteria: any adult patient with acute ankle trauma + one or more criteria of the ottawa ankle rules : * inability to walk 4 steps immediately after the trauma or in the emergency room, * pain at the level of the internal or external malleolus (the distal 6 cm) or the base of the 5th metatarsal bone. exclusion criteria: * any patient under the age of 18 years * any patient unable to sign the informed consent * skin lesions contraindicating sonography (e.g. open fracture wound, ... ) * an unstable patient whose inclusion in the study would delay vital treatment

Keywords: fracture ankle fracture foot frature metatarsus ultrasound x-ray
endo-band: endoscopic band ligation for weight loss

Conditions: Obesity

Summary: to the best of our knowledge, this is the first study to use endoscopic band ligation for weight loss. all ligatures will be performed in the gastric body starting at the distal body; 5 parallel rows, with the last one in the proximal body.the entire procedure can be completed in 30 min. oxygen is used for endoscopic air insufflation.endoscopy is performed using propofol for sedation.

the idea of band ligation of the gastric body is to induce multiple gastric ulcers that forms a fibrotic scars which can lead to marginal narrowing of the lumen; same as that occurred in the esophagus following band ligation of esophageal varices or in the antrum following band ligation of gave.

Eligibility criteria:
inclusion criteria: * bmi \> 27 exclusion criteria: * any contraindication for endoscopy * any gastric bleeding lesions * uncontrolled use of anticoagulants or nsaid's

Keywords: obesity bmi
study of treatment high risk and/or low risk acute lymphoblastic leukémia(all) adults stage iii

Conditions: Leukemia, Lymphocytic, Acute

Summary: improved outcome of high risk lymphoblastic leukemia (all) with laite high dose therapy. high dose versus conventional therapy for adult low risk t-all and lymphoblastic lymphoma (lbl).

comparison between two autograf therapeutic strategies in high risk patients ramdomised comparison between maintenance treatment with or not interferon alpha 2 a

Eligibility criteria:
inclusion criteria * all high risk or low risk or lymphoblastic lymphoma * age 15-55 years old * informed consent signed exclusion criteria: * patients previously treated with a chemotherapy or alpha-interferon * all 3 (burkitt like)
elastography in predicting renal outcome

Conditions: Kidney Disease

Summary: there are two types of elastography: strain elastography assesses the degree of strain when applying a given amount of force to the skin. shear-wave elastography assesses the velocity of shear wave propagation within the target lesion. a part of the tissue is deformed by a "push pulse", the velocity of the shear waves propagating within the tissue is detected, and the stiffness of the tissue is assessed based on the detected shear velocity. shear-wave elastography has been intensively studied in thyroid, breast, liver, cervical lymph nodes, and musculoskeletal diseases with promising result. transthoracic shear-wave ultrasound is also used for the prediction of lung malignancy. in progressive renal disease, renal function decline correlates with the extent of interstitial fibrosis, irrespective of the original pathology. experience and research in using shear-wave elastography to study the stiffness of renal parenchyma and renal fibrosis are scanty. the investigators will conduct a prospective observational study. this study aims to provide the information of tissue elasticity in different etiologies of renal diseases and to validate the predictive value of shear-wave elastography in predicting renal function and renal fibrosis. by assuming a power of 0.8, a two-side p value of 0.05, a ratio of 0.2 (sample sizes in negative/positive groups) to detect the difference between area under roc curve and null hypothesis value (0.8 and 0.7), a target sample of 273 (with a 5% cushion, 260\~290) patients is required.


Eligibility criteria:
inclusion criteria: * patients receiving scheduled renal biopsy and scheduled renal sonography exclusion criteria: * age \< 20 y/o, patients who can't hold their breath for at least 5 seconds

Keywords: elastography
proquad dose selection study (v221-011)(completed)

Conditions: Measles; Mumps; Rubella; Varicella

Summary: a study comparing three different doses of proquad to concomitant administration of m-m-r ii and puvv (process upgrade varicella vaccine) vaccines.


Eligibility criteria:
inclusion criteria: * in good health * negative clinical history of measles, mumps, rubella, varicella, and zoster exclusion criteria: * previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination * any immune impairment or deficiency * exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination * vaccination with an inactive vaccine with in the past 14 days * vaccination with a live vaccine within the past 30 days * immune globulin or any blood product administered in the past 3 months
omega-3 supplementation for smell dysfunction

Conditions: Sellar/Parasellar Tumor; Smell Dysfunction

Summary: omega-3 supplementation has been shown to have neuroprotective and potentially anti-inflammatory properties in both central and peripheral nerve injuries. the investigators are studying to see if omega-3 supplementation will affect olfactory (smell) function in patients with olfactory dysfunction following endoscopic removal of pituitary tumors.


Eligibility criteria:
inclusion criteria: * sellar/parasellar tumor scheduled to undergo endoscopic transnasal transsphenoidal resection * 18 years of age or older * english speaking exclusion criteria: * currently using blood thinning agents (aside from nsaids or cardioprotective asa) * elevated ast, alt, or alk phos \>10% outside of normal range, if randomized to omega-3 group * diabetes, if randomized to omega-3 group and not already on omega-3 prescribed by another provider * unable to provide informed consent due cognitive deficiencies

Keywords: endoscopic sellar/parasellar tumor resection
predictors of poor prognosis in hfpef

Conditions: HFpEF

Summary: patients with hfpef who have undergone meticulous clinical and instrumental evaluation (including diastolic exercise testing) between 2013 and 2020, will be followed up for at least 3 years.

heart failure with preserved ejection fraction (hfpef) is a serious condition with an unfavorable prognosis. the investigators aimed to evaluate in patients with hfpef: * the prognostic significance of standard resting hemodynamic parameters compared to key cardiac reserves; * the prognostic significance of clinical parameters (sex, age, nyha class, extra-cardiac diseases, therapy); * the prognostic significance of biological markers of hemodynamic stress and biomarkers of inflammation and fibrosis; * to identify independent predictors of adverse prognosis of hfpef.

Eligibility criteria:
inclusion criteria: 1. signed and data informed consent; 2. new york heart association (nyha) class ii-iii heart failure; 3. left ventricular ejection fraction \> 50%; 4. elevated lv filling pressures assessed by echocardiography at rest or at peak exercise. exclusion criteria: 1. evidence of myocardial ischemia during stress echocardiography; 2. significant lesions of the main coronary arteries; 3. genetic forms of hfpef (hcm, amyloidosis, fabry disease, glycogen storage diseases etc.); 4. peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided hf without left-sided structural disease, constrictive pericarditis, significant pericardial effusion; 5. significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy); 6. primary pulmonary artery hypertension; 7. significant left-sided structural valve disease; 8. anemia (hb \< 100 g/l); 9. impaired renal function, defined as estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m2 (ckd-epi); 10. non-cardiac conditions that complicate/exclude participation in the study; 11. exacerbation of heart failure less than 3 months prior to study entry.

Keywords: hfpef hf diastolic dysfunction left ventricle (lv) filling pressures left ventricular hypertrophy cardiac reserves myocardial fibrosis
drug-drug interaction trial of bi 113608 in combination with ketoconazole and voriconazole in healthy male subjects

Conditions: Healthy

Summary: the primary objective of this trial is to investigate the relative bioavailability of a single oral dose of bi 113608 without and with ketoconazole and voriconazole at steady state. the assessment of safety and tolerability of bi 113608 administered alone and upon co-administration will be an additional objective of this trial.


Eligibility criteria:
inclusion criteria: 1. healthy male subjects exclusion criteria: 1. any relevant deviation from healthy conditions.
control of leukocyte function

Conditions: Inflammation, Brain

Summary: the protocol is to draw peripheral blood from healthy volunteers for in vitro studies. the aims of these in vitro studies are to determine the cellular and intracellular mechanisms by which hypertonic saline and atp release regulate neutrophil and lymphocyte functions.

the proper regulation of leukocyte function is critical for immune defense and to prevent autoimmune diseases. many aspects of immune cell regulation are unknown. a better understanding could lead to novel therapeutic approaches to improve immune function in patients suffering from various diseases. the investigators have found that hypertonic conditions regulate leukocyte functions through feedback mechanisms involving atp release and purinergic receptors. the purpose of the proposed protocol is to obtain access to peripheral blood from healthy volunteers to study these complex regulatory mechanisms in more detail.

Eligibility criteria:
inclusion criteria: * any healthy volunteer exclusion criteria: * pregnancy * needing/using drugs * inflammatory or infectious complications

Keywords: infection
pain and safety of restylane perlane with and without lidocaine for correction of moderate and severe nasolabial folds

Conditions: Nasolabial Fold

Summary: the purpose of this study is to evaluate the pain and safety in associated with injection of restylane perlane lidocaine compared to restylane perlane using vas scale


Eligibility criteria:
inclusion criteria: * signed and dated informed consent to participate in the study. * men or women aged 20 years or older of chinese origin. * subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study. * intent to undergo correction of both nasolabial folds (nlf) with a wrinkle severity in wrinkle severity rating scale (wsrs) of either grade 3 on both nlfs or grade 4 on both nlfs. exclusion criteria: * previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim. * previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment. * previous tissue revitalization treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion in the midface within 6 months before treatment. * scars or deformities, active skin disease, inflammation or related conditions near or in the area to be treated. * other condition preventing the subject from entering the study in the investigator's opinion
intraoperative handover checklist of anesthesia care improves outcomes among patients undergoing major surgery

Conditions: Anesthesia; Surgery--Complications; Burnout, Professional

Summary: implementation of a standardized handover checklist for intraoperative anesthesia care transition attenuates burnout among anesthesiologists and improves postoperative outcomes of patients undergoing major surgery , both of which benefit the quality of patient care and the development of anesthesiology.

many retrospective studies have demonstrated that among adults undergoing major surgery, complete handover of intraoperative anesthesia care compared with no handover was associated with a higher risk of adverse postoperative outcomes. anesthesiologists keeping on working without handovers may experience symptoms of burnout which do not only pose a threat to the mental and physical health of the anesthesiologist, but also result in sub-optimal safety care of patients. poor-quality handover without standardized processes can lead to diagnostic and therapeutic delays and precipitate adverse events. an improved system of anesthesia standardized handovers using a checklist would improve transfer of information and professional responsibility and therefore lead to the improvement of patient safety as well as burnout among anesthesiologists. thus it is urgent to develop a standardized handover checklist for intraoperative anesthesia care to improve postoperative outcome of patients.

Eligibility criteria:
inclusion criteria: * adult patients aged 18 years and older undergoing major surgeries requiring a hospital stay of at least 1 night are enrolled in this study. exclusion criteria: * adult patients aged less than 18 years undergoing major surgeries and were not requiring a hospital stay of at least 1 night are excluded.

Keywords: major surgery ansethesia care postoperative complication handover checklist anesthesiologist burnout
switching to duloxetine from other antidepressants

Conditions: Major Depressive Disorder

Summary: a multicentre, randomised, open label study of out-patients with major depression who have failed to respond adequately to antidepressant treatment for their current episode of depression. the study compares outcomes associated with two methods of switching from current antidepressant to duloxetine


Eligibility criteria:
inclusion criteria: * male and female outpatients of at least 18 years of age, who meet criteria for major depressive disorder (mdd) * currently non- or only partially-responsive to an ssri antidepressant after at least 5 weeks of treatment exclusion criteria include: * current primary axis i disorder other than mdd * previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders * patients judged to be at serious suicidal risk. * serious medical illness
discovering new treatments for asthma and copd. a new human rhinvovirus for human challenge

Conditions: Rhinovirus

Summary: a gmp rhinovirus was manufactured according to gmp and then characterised in human volunteers in the human viral challenge model.

human rhinovirus infection is an important precursor to asthma and chronic obstructive pulmonary disease exacerbations and the human viral challenge model may provide a powerful tool in studying these and other chronic respiratory diseases. in this study we have reported the production and human characterisation of a new hrv-16 challenge virus produced specifically for this purpose. an hrv-16 isolate from an 18 year old experimentally infected healthy female volunteer (university of virginia children's hospital, usa) was obtained with appropriate medical history and consent. we manufactured a new hrv-16 stock by minimal passage in a wi-38 cell line under good manufacturing practice conditions. having first subjected the stock to rigorous adventitious agent testing and determining the virus suitability for human use, we conducted an initial safety and pathogenicity clinical study in adult volunteers in our dedicated clinical quarantine facility in london.

Eligibility criteria:
inclusion criteria: * young healthy adults as determined by medical history, physical examination, serology (hiv and hepatitis b and c) and clinical laboratory tests. * female subjects were required to provide of a history of reliable contraceptive practice. exclusion criteria:included; * asthma, * hypersensitivity to mercurials or chicken eggs, * anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, chronic nasopharyngeal complaints, * abnormal electrocardiogram (ecg), * febrile illness or significant symptoms of upper respiratory infection on the day of * subjects using medication or other products for rhinitis or nasal congestion, * subject who had received systemic glucocorticoids within 1 month, or cytotoxic or immunosuppressive drugs within 6 months of the study start. * subjects agreed not to smoke during the quarantine phase.