Kornimate/medical-research-clean huggingface dataset:
comparison of the safety and efficacy of intravenous iron versus oral iron in the treatment of anemia secondary to heavy uterine bleeding

Conditions: Anemia

Summary: this study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding

this is an open-label, randomized, phase iii, active-control, study of the efficacy and safety of iv iron vs oral iron in patients with anemia secondary to heavy uterine bleeding.

Eligibility criteria:
inclusion criteria: * female subjects \>/= 18 years of age * history of heavy uterine bleeding * hgb \</= 11 * practicing acceptable birth control * demonstrate ability to understand and comply with protocol exclusion criteria: * known hypersensitivity to oral or iv iron * anemia other than iron deficiency anemia * iron storage disorders * initiation of treatment that may effect degree of heavy uterine bleeding * anticipated need for surgery * severe psychiatric disorder * active infection * positive pregnancy test * known hep b or c or active hepatitis * received investigational drug within 30 days * alcohol or drug abuse

Keywords: anemia heavy uterine bleeding menorrhagia anemia secondary to heavy uterine bleeding
a safety evaluation of ecg intervals and blood pressure in normal healthy volunteers after use of nebivolol, atenolol, moxifloxacin, or placebo

Conditions: Hypertension

Summary: nebivolol is one of a class of drugs known as beta-blockers. these drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. the purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as qtc prolongation. the potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the fda; avelox (moxifloxacin), an anti-biotic approved for use by the fda which is known to cause qtc prolongation; and placebo, a drug look-alike that contains no drug. the working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected qt intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on day 7.


Eligibility criteria:
inclusion criteria: * men and nonpregnant, nonlactating women were 18 years or older. * women declaring postmenopausal or surgical sterility. * women of childbearing potential who had a negative serum hcg within 2 weeks of dosing. * male subjects weighed at least 60 kg (132 lb), and female subjects weighed at least 48 kg (106 lb). all volunteers weighed within 15% of their ideal body weight (ibw). exclusion criteria: * institutionalized * reported or was known to have done the following: * used any tobacco product. * ingested any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication * consumed grapefruit or grapefruit containing products within 7 days prior to the initial dose of study medication. * ingested any vitamins or herbal products within the 48 hours prior to the initial dose of study medication. * recently changed dietary or exercise habits significantly * used any medication (including over-the-counter \[otc\]) within the 14 days prior to the initial dose of study medication. * used any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication. * received an investigational drug within 30 days prior to the initial dose of study medication. * history of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease. * history of drug and/or alcohol abuse within 1 year prior to the study. * acute illness at the time of either the pre study medical evaluation or dosing. * any laboratory results deemed clinically significant by the physician. * abnormal and clinically relevant ecg tracing. * donated or lost a significant volume of blood or plasma (\>450 ml) within 28 days prior to the initial dose of study medication. * allergic or hypersensitive to nebivolol, atenolol, or other β blocking drugs or to moxifloxacin or other quinolone antibiotics. * history of seizures or cerebrovascular disease.
analyzing challenging clinical discussions in orthopaedics

Conditions: Teach-Back Communication; Arthritis; Knee Osteoarthritis; Knee Arthropathy

Summary: the goal of this study is to analyze patient:provider communication surrounding the discussion of difficult clinical conversations such as knee replacement options. this study will also examine how using the teach-back communication technique can improve communication between patients and providers. orthopedic residents, fellows, physician assistants, and attendings that agree to participate will be consented. patients, who are likely to engage in a difficult clinical conversation, such as those who have a clinical indication for a total knee replacement or a partial knee replacement, will be recruited from participating providers clinical schedules. patient:provider interactions will be recorded and then the providers will attend a 1 hour education lecture about how to use teach-back. after attending the lecture, additional patient:provider interactions will be recorded and analyzed via a qualitative approach. additionally, providers will participate in a semi-structured interview to capture their perceptions of teach-back and what challenges and benefits they may derive from using it.


Eligibility criteria:
inclusion criteria (patient participants): * age 18 years and older * clinical indication for multiple treatment options exclusion criteria (patient participants): * non-english speaking * minors or non-consenting other individuals (spouses, friends, family members, children) in the patient room during the clinical visit inclusion criteria (provider participants) * age 18 years and older * a resident, fellow, physician assistant, or attending in the duke department of orthopaedic surgery exclusion criterion (provider participants): • non-english speaking
driving pressure-guided peep titration in robot-assisted laparoscopic surgeries

Conditions: Atelectasis, Postoperative Pulmonary

Summary: the purpose of this study is to investigate the effect of driving-pressure guided positive end-expiratory pressure (peep) titration.


Eligibility criteria:
inclusion criteria: * patients undergoing robot-assisted laparoscopic prostatectomy with trendelenburg position exclusion criteria: * american society of anesthesiologists physical status iv or more * severe cardiovascular disease * severe chronic obstructive pulmonary disease, emphysema * history of pneumothorax, bullae * history of lung resection surgery * conversion to laparotomy * refusal to participate

Keywords: driving pressure positive end-expiratory pressure lung ultrasound
hydroxychloroquine vs nitazoxanide in patients with covid-19

Conditions: Coronavirus Infection

Summary: coronaviruses (cov) are positive-sense single-stranded rna viruses that infect a wide range of hosts producing diseases ranging from the common cold to serious / fatal events. nitazoxanide (ntzx) is a derivative of 5-nitrothiazole, synthesized in 1974 by rosignol - cavier. ntzx has powerful antiviral effects through the phosphorylation of protein kinase activated by double-stranded rna, which leads to an increase in phosphorylated factor 2-alpha, an intracellular protein with antiviral effects. the purpose of this study is to contrast the beneficial effect of ntzx vs ntzx plus hydroxychloroquine in patients coronavirus disease (covid-19) as well as against other treatments.

introduction the current pandemic caused by the sars-cov2 coronavirus (covid-19) is life-threatening and is challenging the world's best health systems. accelerated spread of this pandemia led physicians to try a variety of treatments without a well established sequence due to ignorance about this new disease. the case fatality rate has been calculated at 2.2% but there are differences depending on the country affected. perspective when comparing the evolution of cases between spain and mexico, an apparently less pronounced trend is observed in mexico, but this may be due to underdiagnosis. in calculations by the mexican ministry of health, around 6% of the patients (approximately 10,500) who contract covid-19 could be found serious and in need of hospitalization in intensive care. ntzx ntzx and its circulating active metabolite, tizoxanide, inhibit the replication of a wide range of viruses, both rna and dna. it has action against 16 strains of influenza a virus subtypes h1n1, h3n2, h3n2v, h3n8, h5n9, h7n1 and a strain of influenza b. it also works against respiratory syncytial virus, norovirus, dengue, yellow fever, japanese encephalitis virus, rotavirus , hepatitis b and c, even against the human immunodeficiency virus (severe acute respiratory syndrome (sars) and middle east respiratory syndrome (mers). problem mexico is in phase 2 according to the world health organization (who) and more local infections due to coronaviruses are expected. to date, various covid-19 treatment schemes are being tested, but the usefulness of none can be assured. when reviewing the drug schemes that are being carried out in the world, it calls the attention that developing countries are not included, beyond the fact that the tested alternatives are economically inaccessible. this clinical survey aims to test the possible utility of ntzx against covid-19, alone or in combination with hydroxychloroquine.

Eligibility criteria:
inclusion criteria: * covid-19 positive patients * treated at the health institute of the state of mexico (isem). * with risk factors to get complicated: age more than 60 years old, diabetes mellitus or obesity grade ii or more. exclusion criteria: * patients who have inherent contraindications to each drug.

Keywords: treatment evolution
modulating auditory symptoms and vertigo of meniere's disease by non-invasive mastoid electric stimulation

Conditions: Meniere's Disease

Summary: this study is a double-blind, randomized, sham-controlled, investigator-initiated trial. to explore the effectiveness of non-invasive inner ear electrical stimulation of the mastoid behind the ear in controlling auditory symptoms and dizziness in patients with meniere's disease.


Eligibility criteria:
inclusion criteria: * patients with dizziness (meniere's) only, who understand the nature of the study and are willing to participate voluntarily. * the frequency of the hearing loss is between 250 khz and 1 khz. * patients with bilateral 500, 1000, and 2000 hz hearing threshold averages within 65 db hl * patients who have received conventional pharmacotherapy for other dizziness conditions with a washout period of 2 months. * to be eligible for subjects in the active phase of the disease, there must be at least 1 vertigo attack in the 6 months before study entry. * if tests for renal function, electrolytes, etc. are performed and no problems are found exclusion criteria: * patients with an otologic condition other than meniere'ss (dizziness) (otitis media, profound hearing loss, hyperacusis, etc.). * patients' conditions that may affect eeg measurements, such as a stroke, brain hemorrhage, or brain tumor. * patients with kidney disease * patients have or have had a serious medical condition, such as cancer (including leukemia, blood cancers, epilepsy, and neuropsychiatric conditions). * patients with an artificial implant in the body (cochlear implant, hip joint, pacemaker, etc.) * women of childbearing potential, pregnant women, or nursing mothers * patients who can have injuries or dermatologic abnormalities at the site of application of the equipment. * patients with coronary artery disease, uncontrolled high blood pressure, or other serious medical conditions (including kidney disease).

Keywords: electrical stimulation electroceutical meniere's disease
role of oxytocin in post-menopausal osteoporosis: evaluation on the population of the opus cohort

Conditions: Osteoporosis

Summary: oxytocin is a neurohypophysial hormone involved in several central and peripheral functions including parturition, milk let-down reflex and social behaviour. in vitro and animals studies have shown growing evidence that oxytocin plays a role in bone remodeling and osteoporosis. the investigators have previously show in a small sample of post-menopausal women with severe osteoporosis (n=20) compare to healthy control (n=16) that oxytocin serum level is significantly decreased, independently of leptin and estradiol, that are known to modulate oxytocin secretion. thus, oxytocin appears as a new interesting factor in the osteoporosis pathophysiology. the aim of the present study is to confirm the relationships between bone status, evaluated by bone mineral density and prevalent fragility fractures, body composition and oxytocin serum levels on a large population. the investigators will also determine if the relationship between bone mineral density and oxytocin is independent of estradiol and leptin in this population and evaluate the relationships between oxytocin serum level and co-morbidities such as cardiovascular diseases, depression and dementia. theses analysis will be done on the serum already available of 1000 women of the international opus cohort. bone mineral density, body composition analysis by dual energy x-ray absorptiometry (dxa), estradiol and clinical data are already available. the investigators will select women, aged from 55 to 79 y at the time of inclusion.


Eligibility criteria:
inclusion criteria: * post-menopausal women, * able to undergo bone density, * without cognitive limitation, * age at the time of inclusion: 55 -79y, * written consent. exclusion criteria: * individuals were excluded because of inability to undergo bone densitometry or perform specified investigations or because of cognitive limitations
clariti (tm) 1-day multifocal contact lenses performance and acceptance evaluation

Conditions: Presbyopia Correction

Summary: a comparative evaluation of a newly marketed multifocal contact lens with a single vision contact lens when used with near vision spectacles. the evaluation was to quantify the difference between the two test corrections.


Eligibility criteria:
inclusion criteria: 1. age 45 years or more 2. spectacle or soft contact lens wearer 3. refraction: best sphere (corrected for back vertex distance) -6.00 diopters (d) to +4.00 d; astigmatism - 0.00 d to -0.75 d; near addition for 40 cm; medium add: +1.50 d to +2.00 d; high add: +2.25 d to +2.50 d 4. best spectacle corrected visual acuity of 6/9 or better in each eye 5. willingness to adhere to the instructions set forth in the clinical protocol 6. signature of the subject informed consent form after review of information to participant document. exclusion criteria: 1. systemic or ocular allergies which might interfere with contact lens wear 2. systemic disease which might interfere with contact lens wear 3. ocular disease which might interfere with contact lens wear (e.g. hypothesia, insufficient lacrimal secretion) 4. use of medication which might interfere with contact lens wear 5. active ocular infection 6. use of ocular medication 7. significant ocular anomaly 8. presence of two or more corneal scars in either eye 9. monovision contact lens wearers 10. pregnancy or lactation 11. any medical condition that might be prejudicial to the study 12. participants non-able to give consent or from a vulnerable group 13. infectious disease (for example, hepatitis, tuberculosis, etc.) or a contagious immunosuppressive disease (such as hiv, aids, etc.) 14. employees or family member of the investigational clinic (e.g. investigator, coordinator, technician)
quality of recovery awake versus asleep craniotomy

Conditions: Brain Tumor

Summary: awake craniotomy (ac) is an anesthetic and surgical technique commonly used to resect tumors involving or adjacent to the eloquent or motor cortices, those portions of the brain that are responsible for language and motor skills, respectively. by mapping those areas of the brain that are necessary for such functions, the neurosurgeon is able to avoid resection of cortical tissue that might compromise the patient's abilities to speak or move, hence preserving neurologic function. ac is often accomplished by direct cortical stimulation or inhibition, while maintaining the patient's ability to interact with the operative team. the anesthetic technique often involves a regional (scalp) block combined with intraoperative intravenous mild sedation. in some reported instances of ac, no cortical mapping is performed, and the technique is performed solely because it is thought that ac leads to a better recovery profile (less pain, better neurologic outcome, and shorter hospital stay) than craniotomy performed under general anesthesia. the quality of recovery score (qor-40) is a validated, multi-parameter instrument that has been used in various postoperative populations to assess the overall satisfaction and well-being of patients having undergone anesthesia and surgery. leslie et al. have reported that the qor-40 is a valid tool in assessing neurosurgical patients, but a direct comparison between ac patients and general anesthesia craniotomy (gac) patients using this tool has never been performed. ac may also be associated with better 30 and 90 day multi-parameter outcomes than gac. the well-validated acute short form (sf-12) health survey, an abbreviated version of the sf-36, consists of 12 items. it measures two domains, including mental and physical component summaries (mental component summary and physical composite score, respectively). hypothesis: awake craniotomy for tumor resection is associated with a better multi-parameter quality of recovery in the immediate postoperative period, and better 30 and 90 day quality of life outcomes, than craniotomy performed under general anesthesia.


Eligibility criteria:
inclusion criteria: * adult non-pregnant patients (age ≥ 18 years) undergoing ac or gac for elective supratentorial tumor resection. exclusion criteria: * patients under 18 years of age, non-english speaking, pregnancy, unable to obtain written informed consent, infratentorial tumors.
evaluation of the effect of caudal epidural pulsed radiofrequency stimulation on chronic pain

Conditions: Pain, Chronic

Summary: postlumbar surgery syndrome (plss; failed back syndrome) is characterized by persistent pain in the lower back or lower extremities after spinal surgery. it occurs in 10-40% of patients who undergo a back surgery. the recently introduced pulsed radiofrequency (prf) technique is widely used to provide relief from chronic pain and studies have shown that prf stimulation can be used to control neuropathic pain by placing the needle electrodes into the caudal epidural space the aim of this study is evaluation of the effect of ultrasound guided caudal epidural pulsed radiofrequency stimulation in patients with chronic lumbosacral radicular pain due to postlumbar surgery syndrome.


Eligibility criteria:
inclusion criteria: * chronic pain in legs or back pain * unsatisfactory response to at least one transforaminal, lumbar or caudal steroid injections exclusion criteria: * coagulation disorders * psychiatric disorders * rheumatoid disorders * infections

Keywords: caudal epidural stimulation chronic pain lumbosacral radiculopathy postlumbar surgery syndrome
paravertebral block and erector spinae plane block on intraoperative opioid consumption using nol index

Conditions: Postoperative Pain; Opioid Use

Summary: thoracotomy is among the most painful surgical procedures and can cause severe pain with a high incidence. inadequate treatment of acute postoperative pain may lead to undesired complications. paravertebral block (pvb) is an effective technique that provides adequate analgesia in thoracic surgeries. however, it is an advanced technique with potential complication risks. erector spinae plane block (espb) is a relatively new and considered as a safer technique that provides comparable analgesia. however, the results are controversial and there are few studies that compares the effect of these blocks in thoracic surgeries. as well as the undesired effects of inadequate pain management, high doses of perioperative opioid usage may contribute to the development of dose-dependent long-term adverse events. hemodynamic parameters are generally used to determine the intraoperative need for opioids in patients; however, hemodynamic parameters are not standardized and they do not provide a clear assessment. the nociception level (nol) index is generated from five different parameters (heart rate, heart rrate variability, photo-plethysmographic waveform amplitude, skin conductance level, number of skin conductance fluctuations, and their time derivatives) using a finger probe and is a promising monitoring technique. selecting an effective analgesia method and determining the appropriate dose of opioids using nol monitoring can reduce perioperative and postoperative complications and shorten hospital stays, allowing patients to return to daily life sooner. additionally, preventing chronic pain syndromes that may develop in patients with inadequate analgesia, personalizing each patient's analgesia level, reducing healthcare costs, and improving quality of life can be achieved. the data from this study can demonstrate the analgesic efficacy of simpler regional anesthesia techniques, contributing to the widespread adoption of regional anesthesia applications, which is a crucial step in multimodal analgesia, thereby ensuring more effective pain management for surgical patients.


Eligibility criteria:
inclusion criteria: * patients undergo elective thoracotomy surgery * asa physical status i-iii exclusion criteria: * spinal deformities * bmi\>35 * patiens \<50 kg * allergies to study medications