Kornimate/medical-research-clean huggingface dataset:
effect of easy sleep complex essential oil inhalation on sleep disorders

Conditions: Sleep Disorder

Summary: sleep disorders affect human health tremendously. it has been reported that aromatherapy by fragrance inhalation can be used as an adjuvant therapy to modulate parasympathetic nervous activity for relieving stress and mood, and promoting sleep quality. many researches confirmed that lavender essential oil can be used as an adjuvant therapy for sleep disorders. it can effectively relieve stress and modulate physical and mental status. however, many studies about aromatherapy lack sleep detection instruments to objectively confirm their effects on sleep physiology. therefore, this study adopts easy sleep complex essential oil as the experimental group. the lavender essential oil containing orange, petitgrain, rose, lavender, rosewood, ho wood, amyris essential oil and lavender oil is chosen as control group. the subjects will be randomly assigned to one of the two groups. the efficacy results will be evaluated and compared between the two groups. the investigators expect that aromatherapy by fragrance inhalation with easy sleep complex essential oil will improve sleep quality more effectively than lavender essential oil.

a randomized, single-blind, active-controlled trial to evaluate the aromatherapy by fragrance inhalation using easy sleep complex essential oil in patients with sleep disorders.

Eligibility criteria:
inclusion criteria: * the subjects who signs the informed consent form approved by the institutional review board. * adult between the ages of 20-65 with the ability to communicate and describe symptoms. * the subjects has sleep disorders that last for at least three months and more than three nights per week. * pittsburgh sleep quality index(psqi) score greater than 5. * the subjects are willing to cooperate with the study requirements, examinations and tests, including aromatherapy, polysomnography for two consecutive nights, questionnaire and blood tests. exclusion criteria: * the patients with abnormal olfactory system such as brain injury, acute or chronic sinusitis, and the history of nasal surgery. * patients who are currently taking sedatives or stimulant medicine or food such as coffee or refresh drink. * patients with a known history of allergy to aromatherapy or asthma. * patients has severe cardiovascular or pulmonary disease (e.g., cardiac failure or lung failure), or has cancer or other critical illness (e.g., renal dialysis). * pregnant or breastfeeding women.

Keywords: aromatherapy essential oil easy sleep complex essential oil lavender essential oil sleep disorders
metformin as an upstream therapy in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to see if the study drug metformin will help patients who are overweight and have atrial fibrillation. this study aims to see if metformin helps patients stay in normal sinus rhythm after a catheter ablation. metformin is investigational for use in patients with atrial fibrillation. metformin is approved by the food and drug administration (fda) for use in patients with type 2 diabetes mellitus. metformin is used with a proper diet and exercise program to control high blood sugar, and has been shown to help people lose weight. this study aims to look at the effects of metformin on weight loss and heart rhythm in patients with atrial fibrillation.

enrollment: consent, medical history, and dietary education. randomization. treatment metformin 500mg daily and increased as tolerated to 2000 mg daily over three weeks or control -no treatment. 6 weeks. pre procedure safety labs, ekg, atrial fibrillation severity score survey, metformin held 48 hours prior to rhythm control procedure. treatment resumed 48 hours post procedure or when renal function at baseline. treatment plan for 6 months or discontinuation at any time they are found to meet the baseline exclusion criteria. follow-up at 3 month and 6 month post procedure. continuation of treatment at study completion determined by primary cardiologist or care provider.

Eligibility criteria:
inclusion criteria: * all individuals diagnosed with atrial fibrillation and choosing to undergo a rhythm control strategy at robert packer hospital with a bmi ≥ 27 will be eligible for the study. all subjects must be able to understand and willing to sign a written informed consent document. exclusion criteria: * individuals who are already taking metformin or other antidiabetic medications including insulin, have a diagnosis of diabetes, have a known allergy or fda-labeled contraindication to taking metformin, egfr below 30 ml/min per 1.73 m2 or other clinical diagnosis of advanced renal disease,, have acute or chronic metabolic acidosis (serum bicarbonate \ 2 drinks/day on average), have a history of hepatic dysfunction (serum bilirubin 1.5x greater than the upper limit of normal), have a history of new york heart association (nyha) class iii or iv heart failure, or are pregnant will be excluded from the trial.
the effect of acupuncture on patients with noise-induced hearing loss

Conditions: Electroacupuncture; Noise Induced Hearing Loss; Hearing Loss, Noise-Induced

Summary: in an era of advanced industry and commerce, working in a noisy environment is one of the most important risk factors for hearing damage, especially among young and middle-aged people. although acupuncture has been widely used to treat otology-related diseases, such as tinnitus, dizziness, and sudden deafness, there are few studies on the effect of noise-induced hearing loss.

therefore, the purpose of this study is to investigate the effect of acupuncture on patients with noise-induced hearing loss. this study is designed as a randomized, single-blind, control prospective clinical trial. eighty subjects with noise-induced hearing loss were included in the criteria and randomly divided into the acupuncture group and the control group as follows: 1) in the acupuncture group, in addition to the conventional treatment, acupuncture on both sides of baihui (gv20), dazhui (gv14), yifeng (te17), wangu (gb12), zhongzhu (te3), quchi (li11), and connecting yifeng and wangu, and zhongzhu and quchi are given electroacupuncture stimulation (intensity of 1ma, frequency of 2hz), 3 times a week, 15 minutes each time, continuous 6 weeks; 2) the control group was given conventional treatment only. the main assessment is the hearing changes of the pure tone hearing test, which measure the hearing thresholds of 2khz, 4khz, and 8khz respectively; the secondary assessment is the change of the tinnitus handicap index score. the evaluation time includes before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after the end of acupuncture treatment. the results of this study are expected to prove that acupuncture can improve noise-induced hearing loss.

Eligibility criteria:
inclusion criteria: * pure tone audiometry diagnosed noise-induced hearing loss * age: 20 - 65 exclusion criteria: * major medical disease -- cancer, renal disease * pregnancy or milk women * anti-coagulation use * pacemaker use * allergy to needle * denied accept inform consent
a comparator study evaluating microbiological resistance and effects of alternating inhaled antibiotic therapies

Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa

Summary: this is a pilot study of inhaled antibiotic regimens is a pilot study examining clinical and laboratory endpoints of patients on inhaled antibiotic treatments. we hypothesize that alternation therapy utilizing cayston and tobi will inhibit antibiotic resistance and that alternation therapy will result in a decreased incidence of antibiotic resistance to cystic fibrosis (cf) microbial isolates. the long term strategic goal is to develop a model biometric system for selecting a patient's optimal inhaled antibiotic regimen by utilizing clinical and microbiological parameters.


Eligibility criteria:
inclusion criteria: * \> or = to 6 years of age * documentation of cf diagnosis * history of pa present in sputum, on a least one occasion, during the 12 months prior to visit 1. * currently on inhaled antibiotic regiment * must be able to provide written informed consent or assent prior to any study related procedures * ability to expectorate sputum * ability ro perform reproducible pulmonary function test exclusion criteria: * administration of any iv or oral antipseudomonal antibiotic within 28 days prior to visit 1 * any serious or active medical or psychiatric illness, which in the opinion of the investigator, woud interfere with participant treatment, assessment, or compliance with the protocol * current enrollment in an interventional clinical trial

Keywords: cystic fibrosis pseudomonas aeruginosa
study on efficacy and safety of chondroitin sulfate + glucosamine hydrochloride versus celecoxib in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to determine whether the combination of chondroitin sulfate (cs) and glucosamine hydrochloride (gh) has similar efficacy to celecoxib (ce) in the treatment of patients with moderate to severe knee osteoarthritis (oa).

the primary objective of this study is to show that the combination treatment cs/gh has comparable efficacy to ce in pain reduction from baseline to 6 months of treatment measured with the western ontario and mcmaster universities arthritis index (womac) pain subscale in knee oa patients with moderate to severe pain.

Eligibility criteria:
inclusion criteria: * at least 40 years of age * primary oa of the knee according to the american college of rheumatology (acr) criteria * oa of radiological stages ii or iii according to kellgren and lawrence * patients with moderate-severe knee pain exclusion criteria: * subjects with active malignancy of any type or history of a malignancy within the last five years * concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, wilson's disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease * pain in other parts of the body greater than the knee pain that could interfere with the evaluation of the index joint * patients with fibromyalgia * subjects with a history of heart attack or stroke, or who have experienced chest pain related to heart disease, or who have had serious diseases of the heart * subjects with high risk of cardiovascular (cv) events * subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, hiv positivity) or fungal infections * subjects with a history of recurrent upper gastrointestinal (ugi) ulceration or active inflammatory bowel disease (e.g., crohn's disease or ulcerative colitis), a significant coagulation defect * subjects who have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication * washout period for oa treatments before beginning the study.
diagnostic performance of 18f-fdg-pet and diffusion-weighted mri in the assessment of stage ib to iib2 cervical squamous-cell carcinoma response to concomitant radiochemotherapy and brachytherapy

Conditions: Cancer of the Uterine Cervix

Summary: rationale: the benefit-risk ratio of surgery following concomitant radiochemotherapy and brachytherapy remains to be defined in cervical squamous-cell carcinoma (scc) treatment. scarce studies evaluated the interest of 18f-fdg-pet and mri in the assessment of response to treatment before surgery. a positive predictive value of 75% was found in a small study making 18f-fdg-pet a promising tool to assess tumor response and guide surgical approach. diffusion-weighted mri was also described as an early and sensitive indicator in other diseases. objectives: the main objective of this study is to evaluate the sensitivity of 18f-fdg-pet in the assessment of cervical cancer response to radiochemotherapy and brachytherapy. secondary objectives focus on 18f-fdg-pet specificity and likehood ratios as well as diffusion-weighted mri diagnostic performances. method: we will conduct a prospective cohort study of 148 women with a stage ib to iib2 cervical scc recruited over 2.5 years in 24 centers in france. each patient will undergo a 18f-fdg-pet and a diffusion-weighted mri before surgery and 8 weeks after completion of the brachytherapy. the total follow-up duration (study participation) of patients will be 11 weeks : inclusion after completion of radiochemotherapy and brachytherapy, 8 weeks until 18f-fdg-pet and diffusion-weighted mri, and 3 weeks until surgery. expected results: 18f-fdg-pet and diffusion-weighted mri could constitute a reliable tool to assess response to radiochemotherapy and brachytherapy in cervical scc treatment. if so it could improve clinical practices and be helpful to decide whether the patient needs surgery or not after radiochemotherapy and brachytherapy.


Eligibility criteria:
inclusion criteria: * female patients 18 years of age or older * biopsy-confirmed cervical squamous-cell carcinomas * stage ib2, iia ou iib according to the figo staging of cervical carcinomas * no spread to lumbo-aortic lymph nodes * no prior pelvic radiotherapy * no prior cancer treatment * who performance status less than or equal to 1 * beneficiary of a health insurance * must provide her signed and informed consent exclusion criteria: * reccurent or metastasized cancer * history of uncontrolled cancer, or any cancer treated for less than 5 years (except basal cell carcinomas) * any contraindication to mri * know hypersensitivity to gadolinium, 18f-fdg or one of the excipients * pregnant or breast feeding patients * participation in any other clinical trial that could interfere with the study results * any geographical, social or psychical reasons that could prohibit the ability to return for follow-up assessment

Keywords: 2-fluoro-2-deoxy-d-glucose-positron emission tomography positron emission tomography magnetic resonance imaging diffusion weighted mri squamous-cell cervical carcinoma sensitivity
a study of tirzepatide in participants with type 2 diabetes mellitus (t2dm)

Conditions: Diabetes Mellitus, Type 2

Summary: this is a study for participants with type 2 diabetes mellitus. the main purpose of this study is to learn more about how tirzepatide, semaglutide and placebo affect the body's ability to respond to blood sugar levels after a meal. the study will last up to 40 weeks, including a 28-week treatment period.


Eligibility criteria:
inclusion criteria: * have t2dm for at least 6 months * treated with diet and exercise and stable dose(s) of metformin, with or without 1 additional stable dose of oral antihyperglycemia medication other than metformin, 3 months prior to study entry * have a hemoglobin a1c (hba1c) value at screening of ≥7% and ≤ 9.5 % if on metformin only; or ≥6.5% and ≤9.0% if on metformin in combination with oral antihyperglycemia medications other than metformin * have a body mass index (bmi) between 25 and 45 kilograms per square meter (kg/m² ) inclusive, at screening; are of stable weight (±5%) \>3 months prior to screening exclusion criteria: * have a history of proliferative retinopathy or maculopathy as determined by the investigator based on a recent (\<1.5 years) ophthalmologic examination * impaired renal estimated glomerular filtration rate (egfr) \<45 milliliters per minute per 1.73 square meters (ml/min/1.73 m²) calculated by chronic kidney disease epidemiology collaboration (ckd-epi) * have a history or current cardiovascular, respiratory, hepatic, renal, gi,endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
effect of hydrocortison on post-ischemic flow-mediated dilation and on thenar oxygen saturation in human septic shock.

Conditions: Septic Shock; Adult

Summary: the main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8 hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between post-ischemic flow-mediated dilation (fmd) of the brachial artery (assessed by ultrasound imaging) and post-ischemic recovery slope of the thenar oxygen saturation (sto2) (assessed by near-infrared spectroscopy).

two primary end points, considered as reflecting vasoreactivity will be assessed : 1. flow-mediated dilation (fmd) of the brachial artery, measured by ultrasound imaging, expressed in mm or in percentage, will be calculated from artery diameters measured before and after a vascular occlusion test (cuff around arm or forearm). 2. recovery slope of thenar oxygen saturation (sto2), assessed by near infrared spectroscopy (nirs), expressed in %/second, will be recorded after the vascular occlusion test. the two primary end points (fmd and recovery slope of sto2)will be assessed at the following timepoints : * baseline (before first injection of placebo or hydrocortison) * 2 hours after first injection of placebo or hydrocortison * 2 hours after second injection of placebo or hydrocortison (i.e. 8 hours after first injection) * 4 to 6 hours after third injection * 4 to 6 hours after fourth injection (optional)

Eligibility criteria:
inclusion criteria: * age over 18 yrs * consent obtained * septic shock (according to international definition) * patient sedated and submitted to invasive mechanical ventilation * no need for surgery expected within 24 hours after enrollment * patient has received at least one dose of large spectrum antibiotics * superior vena cava catheter in place * patient carrying a thermodilution device for cardiac output measurement * stable mean arterial pressure within 65-5 mmhg limits for at least 2 hours; exclusion criteria: * pregnancy * age below 18 years * patient treated with iv continuous epinephrine * chronic occlusive arteriopathy of the upper limbs * regular or recent treatment with glibenclamide or glipizide * regular or recent treatment with steroids * known surrenal insufficiency
nava vs. cmv crossover in severe bpd

Conditions: Bronchopulmonary Dysplasia; Neurally Adjusted Ventilatory Assist; Mechanical Ventilation

Summary: this prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and neurally adjusted ventilatory assist (nava) among 20 prematurely born infants and young children receiving invasive respiratory support for severe bronchopulmonary dysplasia (bpd).

most research to date in neonatal lung disease has focused on bronchopulmonary dysplasia (bpd) prevention. as a result, insufficient investigation has been performed to define optimal respiratory management strategies for infants and young children with established bpd. thus, there is no robust evidence base to guide ventilator management to promote lung disease recovery and support neurodevelopment in this population. neurally adjusted ventilatory assist (nava) is an alternative to conventional flow triggered ventilation that has shown promise for improving respiratory gas exchange, patient-ventilator interaction, and work of breathing in preterm neonates. the safety and efficacy of nava in infants and young children with established, severe bpd is uncertain. this prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and nava among 20 prematurely born infants and young children receiving invasive respiratory support for severe bpd.

Eligibility criteria:
inclusion criteria: 1. gestational ages (ga) ≤ 32 weeks 2. current age between 36 weeks postmenstrual age (pma) and 2 years corrected age 3. severe bpd \[as per national institutes of health (nih) consensus definition\] diagnosed at 36 weeks postmenstrual age 4. receiving invasive mechanical ventilation for ongoing lung disease 5. not expected to be ready for extubation within 11 days following enrollment 6. parental consent exclusion criteria: 1. severe congenital anomalies 2. known diaphragmatic defect 3. current treatment with high frequency mechanical ventilation 4. do not resuscitate (dnr) status or futility of care 5. \>10% leak around the artificial airway, 6. treatment with neuromuscular blockade within 72 hours prior to enrollment 7. acute respiratory instability defined as a ventilator rate increase \> 15 beats per minute (bpm), positive end-expiratory pressure (peep) increase \> 2 cm/water (h2o), sustained fio2 increase \> 20%, and/or prescribed increase in tidal volume \> 2 ml/kg within 24 hours prior to enrollment will be excluded.

Keywords: bpd bronchopulmonary dysplasia