Kornimate/medical-research-clean huggingface dataset:
autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy

Conditions: Achalasia

Summary: this prospective observational study aims to investigate the association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy under general anesthesia in achalasia patients. per-oral endoscopic myotomy is known as the effective treatment for achalasia patients. during per-oral endoscopic myotomy, capnoperitoneum, capnomediastinum, and systemic co2 accumulation can potentially impair hemodynamics. moreover, it has been suggested that achalasia is associated with autonomic dysfunction. we hypothesized that patients with autonomic dysfunstion would esperience more hemodynamic instability during per-oral endoscopic myotomy compared with patients without autonomic dysfunction. in this prospective observational study, the autonomic function test will be performed before surgery, and advanced hemodynamic parameters will be recorded using ev1000 clinical platform (edwards lifesciences, usa) during surgery. the association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy will be analyzed.


Eligibility criteria:
inclusion criteria: 1. patients who are scheduled to undergo per-oral endoscopic myotomy in gangnam severance hospital 2. patients aged ≥ 19 years exclusion criteria: 1. patients who are hemodynamically unstable before surgery 2. patients in whom preoperative heart rate variability (hrv) test cannot be conducted 3. pregnant women of breastfeeding women 4. patients unable to read the informed consent form
dual-focus soft contact lenses for controlling rapid progressive myopia in young adults

Conditions: Myopia

Summary: this study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. by applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.

it has long been believed that the progression of myopia mainly occurs during the elementary to high school stages. however, some studies and clinical practice suggest that a considerable proportion of adults still experience myopia progression in their adulthood, especially in those who have prolonged near work or screen usage time. at present, there is insufficient evidence on whether these population needs myopia control intervention. most adults experiencing myopia progression do not receive appropriate myopic intervention measures, leading to an increase of dioptre, which may affect the quality of daily life, and raise the risk of high myopia and blinding myopia complications. this study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. by applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.

Eligibility criteria:
inclusion criteria: * age 18-25 years; * myopia progression \<= -0.50d in either eye in the past year (evaluated by -manifest refraction); * the subject eye: cycloplegic spherical equivalent ranges from -2.00d to -6.0d and cylinder power doesn't exceed -1.50d; * the subject eye's best corrected visual acuity \<= logmar 0.1; * anisometropia does not exceed 1.50d. exclusion criteria: * current use of mc interventions or prior use of mc interventions within the past 6 months; * disease or anatomical factors that affect the wearing of contact lenses; * history of myopia correction surgery; * suffering from ocular or systemic diseases that may be related to myopia, such as marfan syndrome, retinopathy of prematurity, diabetes, etc.; * pregnant female; * other conditions deemed unsuitable by the investigators.

Keywords: myopia dual-focus contact lenses young adults adult myopia progression
removable gore viabil® biliary endoprosthesis for treatment of benign biliary strictures

Conditions: Biliary Strictures

Summary: the purpose of this study is to generate clinical data to support the use of gore® viabil® biliary endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.


Eligibility criteria:
inclusion criteria: * subject is diagnosed with treatable benign biliary stricture which necessitates the need for implantation of a biliary endoprosthesis * subject is ≥18 years of age * subject is able to comply with study protocol and follow-up requirements * written informed consent is obtained using the investigational review board (irb)/ethics committee (ec) approved consent form exclusion criteria: * subject anatomy ruling out covered self expanding metal stent use (e.g. above hilar region) * treatment of stricture would require placement of a covered biliary endoprosthesis within a previously placed bare metal stent * the subject has malignant biliary disease * subject has known pregnancy * participated in protocol involving investigational drug or device within 90 days prior to entry into this study
evaluating the vitamin k2 status of calcium-based stone formers

Conditions: Kidney Calculi; Calcium Oxalate Kidney Stones; Vitamin K 2; Human; Kidney Stone; Calcium Oxalate Urolithiasis; Calcium Phosphate Urolithiasis; Nephrolithiasis

Summary: this is an observation, single site-study with one study visit during which all data and samples will be collected. study participants will be asked to provide blood, urine, and fecal samples so that the investigators may study the differences in the gut microbiota, vitamin k2 levels, and other parameters between participants who form kidney stones and those who do not.

it is hypothesized that calcium-based stone formers will have an altered fecal gut microbiota compared to non-stone former controls. this altered microbiota will have a lower abundance of bacteria that produce menaquinones (vitamin k2), thus stone formers will also have a different blood menaquinone profile compared to controls. ultimately, the different levels of menaquinones will result in increased inactive matrix gla protein (dp-ucmgp), which is a key protein that sequesters free calcium. to test this hypothesis, calcium-based stone former and non-stone forming controls will be recruited to a single site, observation study to collect urine, blood, and fecal samples. these samples will be used to determine dp-ucmgp levels, menaquinone profiles, the composition of the gut microbiota, and other parameters of interest.

Eligibility criteria:
inclusion criteria: * male/female, 18 - 65 years old * no self-reported kidney stones during their lifetime (controls) * ultrasound examination confirming absence of kidney stones (controls) * have had at least 1 incidence of a clinically confirmed calcium-based kidney stone in the last 12 months (stone formers) * ability to collect a clean catch urine sample * prescription and over-the-counter drugs unchanged for ≥30 days * willingness to provide medical information, blood, urine, and fecal samples exclusion criteria: * current, or within 30 days, use of antibiotics or antifungals * current, or within 30 days, use of vitamin k antagonists * current probiotic use or any use within 14 days of screening sample collection should be recorded * a history or currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy 2021-06-29 1.0 page 4 of 6 * fecal incontinence * history of disorder with abnormal calcium regulation such as hyperparathyroidism, active malignancy, or osteoporosis.

Keywords: kidney stone disease microbiota menaquinone vitamin k2 matrix gla protein dp-ucmgp nephrolithiasis
the efficacy of serratus anterior plane block (esapb) for thoracotomy: a prospective study

Conditions: Pain, Postoperative; Anesthesia; Thoracotomy

Summary: thoracotomy is considered the most painful surgical procedure. ultrasound-guided serratus anterior plane block (sapb) is a relatively new truncal block method treating thoracotomy pain. in this study, investigators aim to ascertain the efficacy of sapb in thoracotomy.

thoracotomy is considered the most painful surgical procedure, even with thoracic epidural analgesia (tea) as a golden standard for acute post-thoracotomy pain. ultrasound-guided serratus anterior plane block (sapb) is a relatively new truncal block method treating thoracotomy pain, yet more evidence is needed to ascertain its efficacy. this is a prospective study carried out in a tertiary hospital. patients scheduled for thoracotomy are randomized into two groups: group m (intravenous patient-controlled-analgesia morphine) and group s (intravenous patient-controlled analgesia morphine and sapb). morphine consumption, vas pain score and prince-henry pain score are recorded for 72 hours respectively at pacu, 2hr, 6hr, 12hr, 24hr, 48hr and 72hr, with heart rate, systolic pressure, diastolic pressure, mean arterial pressure and spo2. moreover, the profile of opioids-related side effects and length of hospital stay are documented. the primary objective of the study is to evaluate the efficacy of sapb. the secondary objective is to compare the opioids-related side effects (including nausea, vomiting and pruritus), hemodynamic parameters and the length of hospital stay.

Eligibility criteria:
inclusion criteria: * asa i-ii * bmi 18-28kg/m2 * wedge incision and lobectomy exclusion criteria: * uncontrolled hypertension or chronic conditions * history of opioid dependence * allergy to bupivacaine hydrochloride * severe bleeding during operation or post operation * inability to communicate with investigators.
long-term follow-up to the devo pivotal trial of dermagraft(r) to treat venous leg ulcers

Conditions: Venous Leg Ulcer

Summary: * observe the long-term (1-year) outcomes of dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the abh-dermagraft-001-08 study. * study hypothesis: n/a (long-term follow-up study)


Eligibility criteria:
inclusion criteria: 1. subject has completed study abh-dermagraft-001-08 2. subject understands study requirements 3. subject is available to participate in the 1 year-long observational follow-up. exclusion criteria: 1. subject who withdrew or was terminated from abh-dermagraft-001-08 before completion 2. subject is not available for the 1 year-long observational period. 3. subject has any condition(s) which seriously compromises the subject's ability to complete the study
impact of preoperative midazolam on outcome of elderly patients

Conditions: Preanesthetic Medication

Summary: we aim to assess, if placebo compared to preoperative administration of midazolam in elderly patients is equal in regard to the global postoperative patient satisfaction

generalised premedication with benzodiazepines in all surgical patients has become questionable, regarding the risk-benefit assessment and the lack of evidence for this practice. particularly, in elderly patients (≥65 years), a higher risk for adverse events is described. patients will be randomly assigned to one of the following two study groups. preoperatively, group 1 will receive midazolam and group 2 will receive placebo. anaesthesia will be performed according to the clinical routine. all possible side effects are described in the smpc for midazolam. for the placebo-group, we do not expect any harm, as in the case of strong preoperative anxiety or agitation, additional midazolam application may occur on behalf of the attending anaesthesist at any time. the sample size was calculated based on detecting a minimum of 5 unit difference in the primary outcome variable overall patient satisfaction measured with the evan-g. setting a type 1 error of 0.05, a power of 0.8 and assuming the standard deviation of evan-g to be 14 units, 248 patients per group are needed to detect a 5 unit difference. considering a drop-out of 10% and a screening failure of 10%, we decided to include 614 patients in total. the hypothesis of the study is that global patient satisfaction after surgery in elderly patients is similar after preoperative placebo application compared to midazolam application.

Eligibility criteria:
inclusion criteria: 1. 1. only legally competent patients 2. written informed consent prior to study participation 3. 65-80 years 4. elective surgery 5. expected surgery duration ≥ 30 minutes 6. planned general or combined regional and general anaesthesia 7. planned extubation at the end of surgery exclusion criteria: 1. age \> 80 years 2. age \< 65 years 3. non-fluency in german language 4. alcohol and/ or drugs abuse 5. chronic benzodiazepine treatment 6. intracranial surgery 7. local and stand by anaesthesia or solely regional anaesthesia 8. monitored anaesthesia care 9. cardiac surgery 10. ambulatory surgery 11. repeated surgery 12. contraindications for benzodiazepine application (e.g. sleep apnoea syndrome, severe chronic obstructive pulmonary disease, allergy) 13. allergy against any component of the placebo (lactose monohydrate, cellulose powder, magnesium stearate, microcrystalline cellulose) or investigational drug (midazolam, lactose) or the capsules (gelatine, e171 titanium dioxide, e132 indigotine). 14. expected benzodiazepine requirement after surgery 15. expected continuous mandatory ventilation after surgery 16. patients who explicitly request anxiolytic premedication 17. patients with severe neurological or psychiatric disorders 18. refusal of study participation by the patient 19. parallel participation in interventional clinical studies within the last 30 days

Keywords: midazolam anxiety clinical trial patient satisfaction
a study of immunological biomarkers as predictors of cardiovascular events

Conditions: Cardiovascular Abnormalities

Summary: cardiovascular disease linked to atherosclerosis (e.g. infarcts, cerebro-vascular accidents) are one of the main causes of mortality in the general population. the recruitment of macrophages from the walls of the arterial lumen followed by unregulated capture of oxidated ldl (ldlox) leads to the accumulation of cholesterol esters and the formation of foamy cells characteristic of fatty streaks, the first phase of atherogenesis. these fatty streaks are rarely followed by clinical events, but can progress to complicated atheromatoses (calcification, rupture) resulting in the occurrence of various clinical events such as myocardial infarction and cerebro-vascular accidents (cva). once oxidated, ldl becomes immunogenic and induces anti-ldlox antibody production that could be markers of progression of atherosclerosis. during ldl oxidation, a multitude of specific oxidative epitopes (soe) such as oxidated phospholipids (plox) and malondialdehyde-lysine epitopes (mda) are generated. in order to measure the level of markers in the blood, researchers developed a series of immunologic levels in vitro, using specific antibodies directed against well-defined epitopes. recently, it was shown that lp(a ) would be the preferred transporter of these plox. in fact, several clinical studies show a strong correlation between plox/apob concentrations and lp(a). this marker (plox/apob) predicts future morbidity and mortality due to cardiovascular diseases, including cva, up to 15 years in advance, independent of all other known risk factors. cd36 is a scavenger receptor that recognizes ldlox, but more specifically plox present in these lipoproteins .one soluble form of inflammatory cd36 (scd36) was recently identified. in this study, only healthy volunteers were recruited in order to be able to establish normal serum ranges of different immunologic biomarkers.


Eligibility criteria:
inclusion criteria: * healthy adults * persons providing signed informed consent * persons with healthcare coverage exclusion criteria: * renal disease * cardiovascular disease * auto immune disease * pregnancy in progress * infection * dementia * persons under legal protection * malnutrition

Keywords: cardiovascular events
2012_pharmacocrrt-study:pharmacokinetics of anti-infectives in critically ill patients in need of continuous renal replacement therapy (crrt)

Conditions: Critically Ill; Acute Renal Failure; Acute Kidney Injury

Summary: the main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in critically ill patients in need of continuous renal replacement therapy (crrt), causes inadequate concentrations in plasma. the effect of different modus of crrt: cvvh and cvvhd will be compared, as well as type of filter, filter lifetime etc. hypothesis: the risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving crrt. inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group.

the main purpose of the study is to examine if changes in pharmacokinetics of important antiinfectives in critically ill patients in need of continuous renal replacement therapy (crrt), causes inadequate concentrations in plasma. the effect of different modus of crrt: cvvh and cvvhd will be compared, as well as type of filter, filter lifetime etc. hypothesis: the risk of incorrect dosage of antiinfectives - to low/ to high- is increased in critically ill patients receiving crrt. inadequate plasma concentrations of antiinfectives may contribute to increased mortality in this group. the antiinfectives to be examined are meropenem, fluconazol, cefotaxim, ciprofloxacin, tazobactam-piperacillin, vancomycin,penicillin,cloxacillin. endpoints: 1. measured plasma concentrations of antiinfectives are sufficient for maximal microbial killing. 2. to identify the most important variability factors for plasma concentrations of antiinfectives in patients receiving crrt 3. establish and validate a routine for measurement of vital antiinfectives.

Eligibility criteria:
inclusion criteria: 1. patients admitted to icu in need of antiinfectives: 1. in need of crrt 2. without acute kidney failure 2. requirement for antiinfectives\> 72 hrs 3. age \> 18 yrs 4. signed informed consent exclusion criteria: 1. acute or chronic renal failure not in need of crrt 2. age \< 18 yrs

Keywords: critical illness pharmacokinetics crrt cvvh cvvhd cvvhdf antiinfectives antibiotics minimum inhibitory concentration bacterial killing pharmacodynamics pk/pd index
ldk378 in adult patients with alk-activated nsclc previously treated with chemotherapy and crizotinib

Conditions: Non-Small Cell Lung Cancer

Summary: a single-arm, open-label, multicenter, phase ii study. treatment with ldk378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. ldk378 could be continued beyond recist-defined progressive disease (pd) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. in these patients tumor assessment would continue as per the schedule of assessments until treatment with ldk378 was permanently discontinued. patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of pd as assessed by the investigator


Eligibility criteria:
inclusion critieria: * histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc that carries an alk rearrangement, as per the fda-approved fish assay (abbott molecular inc.). * age 18 years or older at the time of informed consent. * patients must have nsclc that has progressed during therapy with crizotinib or within 30 days of the last dose * patients must have received 1-3 lines of cytotoxic chemotherapy (of which 1 must have been a platinum doublet) to treat their locally advanced or metastatic nsclc * patients must have a tumor tissue sample available, collected either at the time of diagnosis of nsclc or any time since. * patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study. exclusion criteria: * patients with known hypersensitivity to any of the excipients of ldk378. * patients with symptomatic central nervous system (cns) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage cns symptoms. * history of carcinomatous meningitis. * presence or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years. * clinically significant, uncontrolled heart disease * systemic anti-cancer therapy given after the last dose of crizotinib and prior to starting study drug.

Keywords: non-small cell lung cancer nsclc alk ldk378 ceritinib
a trial comparing entacavir and tenofovir in patients with hbv decompensated cirrhosis

Conditions: Cirrhosis Due to Hepatitis B

Summary: entacavir and tenofovir are two first line therapies for chronic hepatitis b. both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in hbv decompensated cirrhosis. the investigators aimed to compare safety/efficacy and virological response in patients with hbv decompensated cirrhosis.

the effectiveness of entacavir and tenofovir has not been prospectively studied in hbv decompensated cirrhosis? this prospective, randomised clinical trial will help us in better patient management more efficacy and cost effectiveness.

Eligibility criteria:
inclusion criteria: * age (18 years- 70 years) * hbv surface antigen positive \> 6 months * hbeag (positive or negative both) * hbv dna 10\^3 * alt uln * no evidence of hcc * platelets count \> 30 thousands * ctp score \> 7 * hepatic encephalopathy (grade 1 - 2 only) * no prior drug resistance exclusion criteria: * age \< 18 years * hcc patients * prior drug resistance * current he \> 2 * solid organ transplantation * inadequate hematological function * co infection with hepatitis c and hiv * autoimmune disorders * pregnancy and breast feeding * other hepatic diseases * patients on immunosuppressant or chemotherapy agents

Keywords: hepatitis b cirrhosis entacavir enofovir
ddavp in the reduction of post-operative ecchymosis in rhinoplasty

Conditions: Postoperative Ecchymosis

Summary: this is study looking at the use of a medication, desmopressin acetate (ddavp), to reduce bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. ddavp is a drug used in patients with bleeding disorders. it works by activating molecules in the blood stream called platelets that promote clotting. in the study, participants who are have cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive medication. photographs taken before and shortly after surgery will be evaluated for the amount of bruising and swelling. patients with heart, lung, kidney, or liver problems are not eligible to participate.


Eligibility criteria:
inclusion criteria: * undergoing rhinoplasty where nasal bone osteotomy is necessary exclusion criteria: * heart disease * renal disease with decreased gfr * liver disease

Keywords: rhinoplasty ecchymosis edema