Kornimate/medical-research-clean huggingface dataset:
evaluation of pharmacokinetics and safety of aju-a51 in healthy adults

Conditions: Diabetes Mellitus, Type 2

Summary: to evaluate the safety and pharmacokinetic characteristics of aju-a51 in healthy adults

this study is to assess the safety and pharmacokinetic characteristics between co-administration of a51r1 with a51r2 and administration of aju-a51. this is an open-label, randomized, single-dose, 2x2 crossover study in healthy male and female subjects to assess the bioequivalence after taking the study drugs.

Eligibility criteria:
inclusion criteria: 1. healthy adults over the age of 19 years at the time of screening 2. individuals who had 18.5 kg/m2 ≤ body mass index(bmi) \< 29.9 kg/m2 and total body weight ≥ 50 kg \* bmi = weight(kg)/ height(m)2 3. individuals who were deemed to be appropriate as study subjects screening examination(laboratory tests and ecg etc.) 4. individuals who agreed proper contraception during the study 5. individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation exclusion criteria: 1. individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric 2. individuals with an active chronic or acute disease within 1 month. 3. individuals with a medical history of gastrointestinal disease (e.g., crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption 4. individuals with a severe allergies(except for allergic rhinitis or dermatitis) 5. individuals with the following medical histories at screening test: * t1dm or diabetic ketoacidosis * galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption etc. * renal disorder or pancreatitis etc. 6. a history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first 7. individuals who cannot eat standard meal in institution 8. women who are pregnant or may be pregnant 9. individuals who were deemed to be inappropriate to participate in the study by the investigator
vestibulo-ocular reflex for balance and stimming in autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder is a neurodevelopmental disorder that encompasses a number of disorders specifically affecting social skills, communication and present with rapid repetitive behaviors. autism spectrum disorder also presents with inability of body to process sensory information which can causes symptoms such as balance deficits, sensitivity to certain sounds or an exaggerated reaction to a normal stimulus. autism spectrum disorder can affect the quality of life of an individual to a severe extent. this disorder due to sensory processing deficits also shows difficulty in motor planning, coordination and execution of tasks which can make performing activities of daily living highly difficult to perform. it is called a developmental disorder because it affects the growth. milestones are often delayed in individuals with autism. due to these deficits individual with autism if not provided with therapies at the right age can stay dependent on caretaker for their whole life. rapid repetitive behaviors also known as self-stimulatory behaviors are a way to compensate with anxiety, difficulty in processing sensory information and are often used to stimulate themselves to feel calm. though not a diagnostic symptom autism often still presents with vestibular dysfunction which affects the balance. several individuals with autism have showed abnormal vestibular ocular reflexes; abnormally long latency of saccades. rehabilitation protocol of autism often includes symptomatic treatment and several therapy protocols such as physical therapy, occupational therapy, applied behavior analysis therapy and play therapy.

stimming behaviors and balance deficits play a huge role in life of an individual with autism. there is indeed a huge gap and lack of literature on how or if exercise protocols from physical therapy can influence balance and reduce stimming behaviors. although, previous studies have recommended that balance and stimming are directly related and that vestibular dysfunction plays a huge role in frequency of stereotyped stimming behaviors. the aim of the study is to investigate the effects of vestibulo ocular reflex exercises on balance and frequency of stimming. this study will also influence how a physical therapist can improve quality of life of an individual with autism by reducing their stimming behavior. earlier studies also mentioned that vestibular ocular reflex is affected in kids with autism. hence this study can play an important role in determining the direct connection between these behaviors, vestibular ocular reflex and balance.

Eligibility criteria:
inclusion criteria: * age 13-18 years * both male and female * diagnosed autism spectrum disorder. * visual and/or vestibular stimming diagnosed by physician. exclusion criteria: * patients diagnosed with other neurological diseases * tumors or neoplasms * visual and auditory impairments * inability to respond to verbal command through verbal or non-verbal communication cues.
evaluation of the effect of laser therapy on lateral pterygoid muscle in patients with wilke's stage i and ii temporomandibular disorders (tmd): case series study

Conditions: Laser; Temporomandibular Joint Disorders; Lateral Pterygoid Muscle

Summary: the purpose of this study will be to evaluate the effect of laser therapy on lateral pterygoid muscle in patients with wilke's stage i and ii temporomandibular disorders (tmd).


Eligibility criteria:
inclusion criteria: 1. patients age between 16-50 years with no sex predilection. 2. patients who will be free from any systemic diseases that affect temporomandibular joint. 3. patients who will be diagnosed with wilk's stage i and ii temporomandibular disorders (tmd). 4. patients who will be ready to give informed consent. exclusion criteria: 1. patients with previous temporo-mandibular surgeries. 2. patients with previous facial fracture. 3. patients who will be under another type of treatment for tmd (e.g., occlusal splints, pharmacological drugs, or head and neck surgery). 4. patients who will not attend the proposed treatment sessions or follow-up visits.

Keywords: laser therapy, lateral pterygoid muscle, wilke's, stage i and ii, tmd.
frontal alpha asymmetry and pediatric emergence delirium

Conditions: Emergence Delirium

Summary: this study aimed to investigate whether the association between the preoperative anxiety level and emergence delirium involves eeg frontal alpha asymmetry in pediatric patients undergoing ophthalmic surgery under general anesthesia. the investigators hypothesized that eeg frontal alpha asymmetry contributes a significant portion of the preoperative anxiety - emergence delirium association in pediatric patients. mediation analysis will be performed to estimate the relationships between preoperative anxiety of children (modified yale preoperative anxiety scale (mypas)), eeg frontal alpha asymmetry, and emergence delirium (pediatric assessment of emergence delirium (paed) scale).


Eligibility criteria:
inclusion criteria: * children aged 2-8 year * children with an american society of anesthesiologists (asa) physical status of i-ii * children who are scheduled to undergo elective ophthalmological requiring general anesthesia exclusion criteria: * emergency surgery * patients with developmental delays * patients with neurological or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances * patients with autism * patients with a recent history (within one month) of receiving general anesthesia * patients with congenital or genetic diseases that may influence brain development
cyberknife for unresectable renal tumors

Conditions: Renal Cancer

Summary: this is a dose escalation study using the cyberknife radiotherapy device for small surgical or medically untreatable renal tumors. patients with renal tumors 5cms or less in diameter will be accrued onto this study. the ability of cyberknife to ablate these renal tumors and maintain renal function with dose escalation will be assessed.

the cyberknife robotic radiosurgery system is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. the cyberknife system delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. this in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.

Eligibility criteria:
inclusion criteria: * tumor size 5 cm or less * radiographic evidence of malignancy or histologically verified primary renal malignancy. * if the kidney biopsy is inconclusive but the radiologist determines that the tumor based on the ct/mri is highly suspicious for cancer, you may participate * patients with highly suspicious lesions on ct or mri * one -three gold fiducials placed in or around tumor * contradiction or patient refusal to partial or complete nephrectomy * age 18 or greater * kps score 70 or greater exclusion criteria: * irreversible coagulopathies that preclude fiducial placement

Keywords: cyberknife
pupillary response after glaucoma medication

Conditions: Drug Effect (Glaucoma Drugs)

Summary: investigation of the effect on the pupillary constriction by latanoprost, dorzolamide,timolol in healthy subjects. the pupillary constriction is compared to no drug.


Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * ophthalmological diseases * systemic disease * smoking * refractive error \>= 6 diopters
hannover dialysis outcome study

Conditions: Acute Kidney Failure

Summary: mortality rates of patients with acute kidney injury in the intensive care unit have changed little over the past few decades despite significant advances in supportive care. few interventions have been shown to result in an improvement of in-hospital mortality of these patients, with dose of renal replacement therapy (rrt) being one of the most important. patients undergoing continuous veno-venous hemofiltration had better outcomes with ultrafiltration rates of 35 ml/kg/h or 45 ml/kg/h than those treated at a rate of 20 ml/kg/h. in a different trial, intermittent hemodialysis on a daily basis resulted in better control of uremia, fewer hypotensive episodes during dialysis, and more rapid resolution of acute renal failure than thrice weekly hemodialysis. in the present study we examine survival and renal recovery in critically ill patients with acute kidney injury that are treated with a currently recommended (standard) dose of rrt, and patients that receive intensified rrt.


Eligibility criteria:
inclusion criteria: * non post-renal aki with rrt dependency indicated by oliguria/anuria \ 6 hours prior to inclusion * loss of kidney function of \>30% within 48 hours prior to inclusion * hyperkalemia \>6.5 mmol/l * severe acidosis with ph\<7.15 exclusion criteria: * pre-existing chronic kidney disease (ckd) as defined by an estimated glomerular filtration rate \ 1.7 mg/dl (\>150 µmol/l) more than 10 days prior to initiation of the first rrt * presence of av-fistula or dialysis catheter * participation in another study * consent denial or withdrawal * need for extra corporal membrane oxygenation therapy.

Keywords: extended dialysis acute kidney injury intensive care unit renal replacement therapy survival dialysis
lifestyle and pregnancy: the clinical effect of lifestyle intervention during pregnancy in obese women

Conditions: Maternal Obesity; Gestational Weight Gain; Obstetric Complications

Summary: obesity is a serious and increasing health problem in the western world with about one third of all pregnant women in denmark being overweight. among these are more than 11% severe obese. obesity in pregnancy is related to higher maternal morbidity and perinatal morbidity and mortality. observational studies indicate that the rate of pregnancy complications among obese pregnant women can be limited if weight gain during pregnancy is restricted. aims of the trial is to study the effects of diet and physical training during pregnancy among danish obese women. also to describe the metabolic effects of lifestyle intervention during pregnancy. 360 obese pregnant women with body mass index (bmi) \> 30 are randomized to lifestyle intervention group or control group. the intervention is composed of individual dietician counselling and physical training. the physical training includes weekly aerobic exercises in a fitness center and lifestyle coaching in small groups. both groups will be examined during pregnancy with extra ultrasound scanning of the fetus, blood pressure, and metabolic markers. all women receive vitamin supplementation to assure sufficient intake.


Eligibility criteria:
inclusion criteria: * singleton pregnant * bmi \>/= 30 and \</= 45 exclusion criteria: * chronic diseases * not danish speaking * abuse of alcohol or drugs * preterm delivery in earlier pregnancies
preoperative laboratory parameters and scorings systems on postoperative pulmonary complications in thoracic surgery

Conditions: Perioperative/Postoperative Complications

Summary: postoperative pulmonary complications (ppc) emerge as a major risk that determines the morbidity and mortality of patients after surgery. ppcs affect the length of hospital stay and increase health costs. because of this reason, it is important to predict ppcs before surgery. there are many studies on scoring systems that can be effective in predicting ppcs. the most frequently used ones are the assess respiratory risk in surgical patients in catalonia (ariscat) risk index, the nutritional risk score (nrs), and the american society of anesthesiologist (asa) score. ariscat risk index is mostly evaluated in operations performed other than thoracic surgery. since the thoracic wall, mediastinum or lungs are directly intervened in thoracic surgery operations, the expected ppcs in these patients may be different from those expected in other surgical groups. therefore, the ariscat risk index may be insufficient to evaluate ppcs in thoracic surgery.


Eligibility criteria:
inclusion criteria: * patients who will undergo elective thoracotomy or video assisted thoracic surgery with general anesthesia * bmi \< 35 kg/m2 * age 18 - 75 years old * expected operative time more than 60 minutes exclusion criteria: * history of lung surgery * advanced lung-heart disease * having a previous covid-19 pneumonia
a study of using parenchymal blood volume(pbv) for endovascular treatment of renal arterial stenosis

Conditions: Renal Artery Stenosis; Renal Blood Perfusion

Summary: this study will use pbv technique to quantitatively assess the improvement of renal perfusion before and after endovascular treatment (evt) of renal artery stenosis.

background: renal artery stenosis (ras) is one of the main reasons for secondary hypertension and renal failure, which etiologies include atherosclerosis, fibromuscular dysplasia and takayasu arteritis. endovascular treatment under digital subtraction angiography (dsa) is an option to treat this disease. however, the technical success of this procedure is mainly based on morphology of its targeting renal artery without any quantified data towards renal blood perfusion. thus, this study will try to solve how renal blood perfusion changes before and after endovascular treatment of renal artery stenosis. design narrative: this prospective cohort study will recruit patients with renal artery stenosis. pbv data will be obtained before and after their endovascular treatments. the volume of target kidney and its mean density of contrast from pbv data will be calculated as indicators for renal perfusion. and the relation between the percentage of stenosis and renal perfusion will be analyzed. the follow-up will last for one year. at 6-month and 12-month follow-up, dsa and pbv acquisition protocol will be undertaken again to evaluate renal blood perfusion in the long term.

Eligibility criteria:
inclusion criteria: patients should meet all of the following criteria: 1. age ≥ 18. 2. renal artery stenosis is greater than or equal to 80% and less than 100% by duplex, ct angiography or magnetic resonance angiography. 3. the target kidney remains functional(tested by radionuclide imaging) 4. documented history of hypertension on two or more anti-hypertensive medications or estimated glomerular filtration rate (egfr) less than 60 ml per minute per 1.73 m\^2, calculated by the modified modification of diet in renal disease formula. 5. the length of target kidney is \>8cm. exclusion criteria: patients meet any of the following criteria should be excluded. 1. unable or willing to comply with study protocol or procedures. 2. pregnancy or lactation. 3. history of kidney transplant. 4. currently in acute pulmonary edema or systolic ejection fraction of heart \<30% or respiratory failure due to hypertension or acute coronary syndrome or cerebrovascular accident in past 3 months. 5. the egfr is less than 15 ml per minute per 1.73 m\^2 or serum cr is greater than 3.0 mg/dl on the day of randomization. 6. other known reason nonischemic kidney injure(e.g. nephritis). if it is diabetic nephropathy, 24h urinary protein should be more then 3g. 7. aorta has stenosis(greater than 30%).

Keywords: renal artery stenosis renal blood perfusion
the study of gut microbiota in hypertensive patients

Conditions: Hypertension; Gut Microbiota; Diet

Summary: recent animal and human studies have found the relationship between the composition of the gut microbiota and hypertension, but some studies did not have a detailed evaluation of the diet content, which could be an important effect on gut microbiota. moreover, most of these studies were finished in western countries, in which the dietary patterns were significantly different from those in chinese regions. this study intends to establish taiwanese local data to explore the differences in the composition of gut microbiota among hypertensive patients and normotensive subjects.

the investigators plan to enroll total 70 hypertensive and normotensive cases from the elderly health examination in cathay general hospital, who are aged from 65 to 80 years. body mass index and blood samples for biochemical analysis such as blood sugar and cholesterol levels are taken, and fecal samples are collected for analysis of gut microbiota, which is characterized by 16s ribosomal rna gene sequencing. besides, the diet and nutrients intake are recorded and calculated by licensed dietitian. through the exploration of gut microbiota in hypertensive patients, the results can be the reference for clinical treatment.

Eligibility criteria:
inclusion criteria: 1. age 65\~80 years old 2. people who join the elderly health examination program in cathay general hospital in 2021 exclusion criteria: 1. antibiotics use within one month 2. acute gastrointestinal illness within one week, such as vomiting and diarrhea 3. history of gastrointestinal surgery 4. history of inflammatory bowel disease 5. chronic gastrointestinal disease under medication treatment 6. cannot finish dietary record
hecthor: humira to spare steroids in giant cell arteritis

Conditions: Giant Cell Arteritis

Summary: hypothesis: in giant cell arteritis (gca), a short initial treatment with anti-tnf may allow a faster decrease of steroids dosage and therefore avoid some of the adverse events of steroids.

the protocol consists of a sc injection of adalimumab or placebo every 2 weeks for 10 weeks added to steroids

Eligibility criteria:
inclusion criteria: * age ≥ 50 years * acr criteria for giant cell arteritis (hunder 1990) * positive temporal artery biopsy * plus standard inclusion criteria for humira protocols exclusion criteria: * prednisone treatment for a different disease at a dose \>15 mg/day * corticoid treatment for gca more than 10 days * gca treatment with prednisone \> 1 mg/kg whatever period of time * gca treatment with an anti-tnf, mtx, cyclosporine, cyclophosphamide, dapsone or steroid bolus * recent, permanent or transient visual loss due to gca and the presence of any specific visual abnormality (diplopia, hallucination) * plus standard exclusion criteria for humira protocols

Keywords: giant cell arteritis placebo anti-tnf multicenter-randomized-trial proved gca according to acr criteria (hunder et al 1990)
vertebral bone marrow lesions by dwi and adc values

Conditions: Vertebral Lesion

Summary: the aim of the work is to assess the utility of apparent diffusion coefficient obtained in diffusion-weighted mr imaging for the differentiation between benign and malignant vertebral lesions.

mri has a high sensitivity in delineating the pathology, its specificity is low. osteoporotic and metastatic compression fractures may be mistaken for each other in the acute phase (wong and suresh, 2018). edema in the acute phase of benign fractures may replace normal bone marrow and cause hypointense signal changes in t1-weighted images and hyperintense signal changes in t2-weighted images, at the same time taking contrast material. these changes are also typical for metastasis and cause confusion in diagnosis when only one lesion is present (mauch et al., 2018). diffusion-weighted imaging (dwi) has recently appeared as a new method of screening in characterizing lesions without necessitating contrast material and in evaluating the vertebrae quantitatively (lee et al., 2019) diffusion-weighted-imaging (dwi) provides microscopic information from water protons which is not possible using conventional magnetic resonance imaging (mri) (partridge et al., 2017). dwi measures the random (brownian) extra, intra and transcellular motion of water molecules (ahlawat and fayad, 2018) apparent-diffusion-coefficient (adc) is a quantitative parameter calculated from dwi that combines the effects of capillary perfusion and water diffusion (wang et al., 2018) in a comparatively small number of surveys, adc values have been studied in discriminating the infectious lesions from the malign lesions the utility of apparent diffusion coefficient obtained in diffusion-weighted mr imaging for the differentiation between benign and malignant vertebral lesions, and to determine the sensitivity and the specificity in differentiating benign and malignant vertebral lesions according to the optimal cutoff adc value (dahnert et al., 2017)

Eligibility criteria:
inclusion criteria: after taking clinical complaint and orthopedic and neurological examinations, all patients (any age or sex) with suspected bone marrow focal lesions will undergo dwi and adc map. exclusion criteria: all patients who contraindicated for mri study as patients with cardiac pacemaker, any metallic stent, claustrophobia and morbid obesity.