Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of activated recombinant human factor vii in severely injured trauma patients

Conditions: Acquired Bleeding Disorder; Trauma

Summary: this trial is conducted in africa, asia, europe, oceania and north america. the aim of this trial is to evaluate the efficacy of activated recombinant human factor vii given in conjunction with standard therapy in the treatment of massive bleeding in subjects with severe blunt and/or penetrating trauma injury.


Eligibility criteria:
inclusion criteria: * informed consent obtained from the subject and/or his/her legally authorised representative (lar) before any trial-related activities * injury(ies) due to a blunt and or penetrating trauma * receipt of 6 units of prbc within a 4 hour period following admittance to the trauma centre * receipt of 8 units of prbc upon administration of trial drug exclusion criteria: * prehospital cardiac arrest * cardiac arrest in the er or or * gunshot wound to the head * glasgow coma scale below 8 * base deficit of above 15 meq/l or severe acidosis * transfusion of 8 units or more of prbc prior to arrival in trauma centre
exercise and compression for lymphedema

Conditions: Breast Cancer Related Lymphedema

Summary: the purpose of this study is to investigate the benefit of combining resistance exercise with use of a compression sleeve on arm lymphedema. in the study, participants will be taught a resistance exercise that follows the decongestive exercise sequence. this program is called "decongestive progressive resistance exercise" (dpre). to evaluate the benefit from use of a compression garment on the arm. some participants will wear their usual compression sleeve during exercise and others will use an adjustable compression wrap. the investigators hope to see if this type of combined program is helpful for women with lymphedema. the investigators also want to see if there are benefits from the addition of use of an adjustable compression wrap during exercise over use of a regularly prescribed compression sleeve.


Eligibility criteria:
inclusion criteria: 1. is a female with a history of breast cancer; 2. has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection; 3. has visible and palpable unilateral mild to moderate bcrl of at least 200 ml inter-limb volume difference (full limb) or regional lymphedema: defined as a minimal volume difference of 100 ml or 5% in a segment of the arm (e.g. hand and forearm region, elbow and upper arm) after correcting for arm dominance; 4. has chronic lymphedema, defined as lymphedema that has been present for at least 3 months; 5. is in the lymphedema maintenance phase of conservative treatment; 6. uses a well fitted compression sleeve (not older than 1 month) and is agreeable to wear the sleeve for a minimum of 12 hours per day (providing a minimum of 30 mm hg of pressure); 7. is agreeable to discontinuing other lymphedema treatments that are beyond standard care, including manual lymph drainage and intermittent pneumatic compression during the 12-week rct period of the study. 8. is able to read and understand english. exclusion criteria: 1. are undergoing or are scheduled to receive chemotherapy or radiotherapy 2. presents with limb infection/ cellulitis, deep vein thrombosis, or have active metastatic disease; 3. has any neurological or cognitive deficit, is pregnant, uses a pacemaker, or has other uncontrolled health condition that may interfere with assessment and/or the progressive resistance exercise training intervention; 4. has any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;

Keywords: decongestive progressive resistance exercise compression sleeve during exercise adjustable compression garment
a study to evaluate thr-317 and ranibizumab combination treatment for diabetic macular oedema (dme)

Conditions: Diabetes Mellitus; Diabetic Retinopathy; Macular Edema

Summary: this study is conducted to evaluate the safety of intravitreal thr-317 administered in combination with ranibizumab, and to assess the efficacy of the combination treatment in improving best-corrected visual acuity (bcva) and reducing central subfield thickness (cst), in subjects with central-involved diabetic macular oedema (ci-dme).


Eligibility criteria:
inclusion criteria: * male or female aged 18 years or older * type 1 or type 2 diabetes mellitus * ci-dme with central subfield thickness of ≥ 320μm on spectralis® sd-oct or ≥ 305μm on non spectralis sd-oct, in the study eye * anti-vascular endothelial growth factor (anti-vegf) treatment naïve study eye, or poor or no response to prior treatment with ranibizumab in the study eye * reduced vision primarily due to dme, with bcva ≤ 72 and ≥ 23 etdrs letter score (≤ 20/40 and ≥ 20/320 snellen equivalent) in the study eye * non-proliferative diabetic retinopathy of any stage in the study eye * written informed consent obtained from the subject prior to screening procedures exclusion criteria: * concurrent disease in the study eye, other than ci-dme, that could compromise bcva, require medical or surgical intervention during the study period or could confound interpretation of the results * previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment * any active ocular / intraocular infection or inflammation in either eye * aphakic study eye * poorly controlled diabetes mellitus * uncontrolled hypertension * pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception
metabolic dysfunction associated fatty liver disease in long-term cholecystectomy patients

Conditions: Liver Steatoses

Summary: the aim of this study was to examine the association between metabolic associated fatty liver disease (mafld) in participants who had undergone cholecystectomy and those who had not undergone cholecystectomy. mafld is defined as hepatic steatosis(with ultrasonography) entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction. in this way, the long-term effects of cholecystectomy surgeries, which are commonly performed in the society and thought to be harmless, will be evaluated.

cholecystectomy is known to be a harmless operation with low perioperative mortality and morbidity. however, the unexplained increase in metabolic disorders in cholecystectomy patients has led to the need for further investigation of cholecystectomy patients. non-alcoholic fatty liver disease is an important health problem with an average prevalence of 25% worldwide and serious hepatic and systemic complications. the aim of this study was to examine the association of cholecystectomy with metabolic dysfunction associated fatty liver disease (mafld), which is an important public health problem in the long-term. this case-controlled cross-sectional study was planned to evaluate the relationship between patients who had undergone cholecystectomy with mafld. mafld is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction. the study included 86 participants with cholecystectomy and 63 participants without cholecystectomy. it was planned to compare the participants according to the diagnostic criteria for mafld (with or without mafld).

Eligibility criteria:
inclusion criteria: * who were found to have undergone cholecystectomy at least five years ago, * who could feed orally and perform activities of daily living * participants who had not undergone cholecystectomy with similar characteristics were included in the study exclusion criteria: * those with chronic liver disease * malignancy or history of malignancy * in a chemotherapy program * with active infection * any organ failure * pregnancy * use of drugs that cause steatosis in the liver

Keywords: ultrasaund obesity cholecystectomy
post-marketing surveillance on the safety of cabometyxtm in korean patients

Conditions: Renal Cell Carcinoma; Hepatocellular Carcinoma; Differentiated Thyroid Carcinoma

Summary: the objective of this post marketing surveillance (pms) is to collect and describe safety and effectiveness profile of cabometyx™ in real clinical practice setting, according to the approved labelling after the approval of marketing authorization.


Eligibility criteria:
inclusion criteria: * patients who meet 'indications' of label for cabometyx™ as monotherapy * patients who are treated with cabometyx™ for the first time according to label for cabometyx™ as monotherapy * patients who are aged 18 years or older * patients who are willing to provide written consent after being informed of this surveillance exclusion criteria: * patients who are contraindicated for cabometyx™ based on cabometyx™ label
influence of deep versus moderate neuromuscular blockade during general anesthesia on 30-day readmission rates

Conditions: Postoperative Complications; Postoperative Wound Infection; Pneumonia

Summary: deep neuromuscular block (nmb) has shown to produce superior surgical conditions during various abdominal and non abdominal surgeries. it is however unknown if the application of deep nmb leads to favourable outcome, such as lower rate of postoperative complications in general and surgical infections in specific and ultimately lower readmission rates. in the leiden university medical center, deep nmb is routinely applied for a variety of procedures, most notably laparoscopic abdominal and retroperitoneal surgery, eye surgery and neuro radiologic intervention surgery, since 2014. this retrospective study intends to investigate whether the application of deep nmb for these procedures affects patient outcome and readmission rates.


Eligibility criteria:
inclusion criteria: * deep neuromuscular block * moderate neuromuscular block * general anesthesia * complete anesthesia chart exclusion criteria: * incomplete anesthesia chart * missing data regarding postoperative complications or readmission
neuroimaging findings in patients with covid-19

Conditions: Neuroimaging; COVID-19

Summary: this study aimed to discuss the neuroimaging findings and indications, epidemiological data, laboratory values, and the relationship of these variables with mortality in patients with covid-19.

covid-19 can present as neurological symptoms such as anosmia, headache, taste perversion, dizziness, syncope, and altered state of consciousness. it has been reported in previous studies that thromboembolic ischemic and hemorrhagic strokes associated with covid-19 have been observed in the early period. it has been suggested that conditions characterized by neurological sequelae, such as encephalitis and encephalopathy, ataxic seizures, guillain-barré syndrome (gbs), demyelinating diseases, and neuromuscular disorders may occur in the longer term.in the present study, the investigators aimed to reveal the findings of neuroimaging analyses performed in patients followed up with a diagnosis of covid-19 who had neurological symptoms, discuss the relationship of these findings with laboratory and epidemiological data, and emphasize that cns involvement in these patients should not be overlooked. in this study, 436 patients with covid-19 who underwent at least one neuroimaging procedure during april 2020-december 2020 due to neurological symptoms and whose diagnosis was confirmed by reverse transcriptase-polymerase chain reaction test were included. although computed tomography was predominantly used for imaging, magnetic resonance imaging was also used when necessary. the patients were grouped based on imaging findings, and statistical evaluations were made between the groups.

Eligibility criteria:
inclusion criteria: * covid-19 rt-pcr positivity- * older than 18 years old exclusion criteria: * younger than 18 years old
the effect of macronutrients in the diet on digestive and cardiovascular health

Conditions: Obesity; Diabetes; Cardiovascular Diseases

Summary: this study examined the effect of a 5-day hfd supplemented with specific fatty acids on gastrointestinal transit, appetite, food intake and substrate utilization. another novel aspect of this chapter was examining whether a subsequent 5-day period was sufficient to reverse the effects of high-fat feeding on the aforementioned parameters.

high-fat (hf) diets of as little as three days have been shown to accelerate gi transit. this study aimed to assess if 5-day hf supplemented diet varying in fatty acid composition were sufficient to accelerate gi transit, appetite responses and substrate utilisation and whether a 5-day deadaptation period to a hf diet would reverse the responses induced by adaptation to a hfd. the study will be conducted in a randomized, single-blinded manner in 24 healthy subjects. three 5-day interventions will each followed by a test trial. in the first intervention period (con), normal diet was supplemented with low-fat (lf) milkshakes (272 kcal, 6 g fat). the second and third interventions will involve repeating previous diet along with hf (1082 kcal, 96 g fat) or lf milkshakes respectively. the three high-fat supplement groups that subjects will be randomized to are as follows: (1) olive oil (90 g oil), (2) olive oil + n-3 epa/dha fish powder blend or (3) olive oil + macadamia oil blend. the effect of 5-day hf diet (daily milkshake supplement: 1082 kcal, 96 g fat) on gastric emptying and mouth to caecum transit time of a high-fat test will be measured using the 13c octanoic acid breath test and h2 inulin breath test respectively for six hours postprandially. during this time course, measurements of subjective appetite sensations by visual analogue scale and substrate utilization by indirect calorimetry were also collected. subsequently, food intake will be measured using an ad libitum buffet meal.

Eligibility criteria:
inclusion criteria: * healthy adults aged 18-35 years exclusion criteria: * history of gastrointestinal-related conditions or gastrointestinal disturbance within 3 months of study entry * diabetes mellitus * cardiovascular disease * allergies to foods in study * pregnancy

Keywords: fats macronutrients appetite gastric emptying gastrointestinal transit
the effectiveness of the android application as a pharmaceutical education tool in hypertensive patients

Conditions: Hypertension

Summary: hypertension is a worldwide public health challenge due to its high prevalence and along with increased risk of complications of other diseases that are more dangerous if not managed properly. an estimated 1.4 billion people worldwide have high blood pressure, but only 14% can control it. knowledge of hypertension in patients with hypertension can prevent complications through hypertension treatment. increasing knowledge can be done by providing education in the form of counseling by pharmacists to hypertensive patients. counseling activities carried out by pharmacists can be supported by a technological approach. one of the uses in smartphone technology is by creating an android-based mobile application that can be developed to support pharmaceutical care. education conducted by pharmacists can increase knowledge that will affect hypertension treatment adherence, and this education can also improve blood pressure control so that it can improve the quality of life. the purpose of this study is to analyze the influence of the android application as a standard pharmacist education tool on knowledge as well as adherence and therapeutic outcomes of hypertensive patients, and quality of life related to the health of hypertensive patients compared to just providing standard education by pharmacists to hypertensive patients at the primary health care. the method used in this study is a quasi-experimental with pretest - posttest control group design. samples were obtained by purposive sampling method at the selected primary health care as the intervention group and the selected primary health care as the control group. pharmacist provides education to intervention groups with android applications as counseling aids and in control groups only standard counseling is provided. pre-test data collection was done by taking primary and secondary data of patients at the first meeting and post-test data collection was taken prospectively through face-to-face interviews and questionnaires on hypertensive patients participants for three months by observing the influence of android applications as counseling aids on knowledge of hypertensive diseases, adherence to antihypertensive treatment, outcome therapy and quality of life.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years, male and female who are willing to be respondents. * patients diagnosed with hypertension or currently taking ≥ 1 antihypertensive drug. * hypertension patients who carry out routine control and receive anti-hypertensive drugs for at least 3 months at the health center. * not illiterate and owns a smartphone. * patients who are willing to participate in the study by signing an informed consent. exclusion criteria: * physical and mental disabilities such as deaf, blind, and psychiatric disorders. * the patient is pregnant * currently taking hormonal drugs and other routine drugs such as tb, hiv and aids drugs.

Keywords: knowledge adherence quality of life smartphone pharmacist
endostatin study for patients with neurofibromatosis type 2 (nf2) and nf2-related tumors

Conditions: Vestibular Schwannoma; Neurofibromatosis Type 2

Summary: 1)preliminarily evaluate the treatment effect of continuous vein injection of recombinant human endostatin on nf2; 2)preliminarily evaluate the safety and the patient's tolerance of the treatment of endostatin; 3)provide an objective basis for an enlarged randomized double-blind trial.

neurofibromatosis type 2 (nf2) is a hereditary tumor predisposition syndrome caused by mutations in the nf2 tumor suppressor gene. individuals with nf2 have a higher likelihood to develop multiple nervous system tumors, including schwannomas, meningiomas, and ependymomas. the hallmark of nf2 is bilateral vestibular schwannomas. historically, most nf2 patients experience complete hearing loss either from tumor progression or after treatment of the tumors with surgery or radiation. effective treatments are urgently needed for nf2 patients with progressive hearing loss because hearing loss is associated with impairment in social, emotional,and communication function and with increased depression. previous studies of nf2 patients treated with bevacizumab suggested that inhibition of vascular endothelial growth factor (vegf) could result in hearing improvement and reduction in tumor size.recombinant human endostatin can inhibit the formation of blood vessels by inhibiting the migration of vascular endothelial cells .in this way, endostatin can inhibit the nutrition of the tumor and decrease the tumor's growth and metastasis. in vitro tests, endostatin can inhibit the cell migration and tube formation of the microvascular endothelial cell line hhec. besides, it can inhibit blood vessels' formation of the chicken embryo sac membrane. based on these studies, we perform this clinical trial to known the treatment effect and tolerability of endostatin on nf2.

Eligibility criteria:
inclusion criteria: * 1)patients must be at the age of 16-30 * 2)patients must meet the diagnostic criteria for nf2, with bilateral acoustic neuroma and other central nervous system tumors * 3)patients must not be treated with other drugs or radiation therapy recently * 4)patients should live in beijing or nearby and can be treated in hospital * 5)patients must be healthy and not be seriously allergic with biological agents * 6)patients must join the clinical trial voluntarily, with good compliance, cooperate with the researchers well, sign a written informed consent. exclusion criteria: * 1)treated with other drugs, surgery or radiation therapy recently * 2)brainstem is compressed seriously, with hydrocephalus, need to be treated with surgery in short time * 3)being pregnant or try to get pregnant, lactating women * 4)with acute or chronic infectious diseases * 5)with heart diseases, cardiac dysfunction or abnormal ecg * 6)with uncontrolled neural or mental diseases, poor compliance * 7)not available for enhanced mri * 8)take part in any other clinical trial * 9)with other conditions that are considered not suitable for this clinical trial.

Keywords: neurofibromatosis type 2 vestibular schwannoma other nf2-related tumors
obstructive sleep apnea syndrome (osa) and getemed

Conditions: Sleep Apnea, Obstructive

Summary: it is often clinically impossible to differentiate children with an isolated snoring from those with osa. the diagnosis of osa is currently based on nocturnal, laboratory-based polysomnography. this expensive examination is poorly accessible due to appointments delays at hospital. our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric osa.


Eligibility criteria:
inclusion criteria: * male and female subjects, aged 2 to 6 years old, requiring a polysomnography or admitted for intense snoring or suspected sleep apnea * parents must have signed the inform consent form and be covered by the national health insurance program. exclusion criteria: * parents opposed to the study.

Keywords: obstructive sleep apnea syndrome polysomnography home monitoring
a clinical study to explore biomarkers for drug-induced liver injury (dili)

Conditions: Healthy

Summary: this study has an open-label, one-sequence, multiple drug administration design. the purpose of this study is as follows; * to evaluate the change of liver function according to glutathione s-transferase (gst) genotype after the multiple administration of amoxicillin/clavulanate. * to evaluate the intrinsic metabolite, human leukocyte antigen (hla) genotype, and microrna (mirna) based on liver function change as the candidate biomarker for dili.


Eligibility criteria:
inclusion criteria: 1. subject with sufficient ability to understand the nature of the study and any hazards of participating in it. provide written informed consent after being fully informed about the study procedures 2. healthy male of female subjects aged 20 - 45 years 3. subjects whose body mass index (bmi) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (exclusive) exclusion criteria: 1. subject with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history 2. subject who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration 3. subject who did blood donation during 1 months before the study or blood donation during 2 months before the study 4. subject with presence or history of severe adverse reaction to study drug 5. subject who cannot prevent pregnancy during the study period. 6. female subject who are pregnant. 7. subject who drank over 21 units/week of alcohol or subjects who would not be able to stop drinking alcohol during the hospitalization 8. subject who are heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization. 9. subject judged not eligible for study participation by investigator.

Keywords: gst, dili, biomarker