Kornimate/medical-research-clean huggingface dataset:
the comparison of two crosslinked hyaluronate for the treatment of osteoarthritis pain

Conditions: Osteoarthritis, Knee

Summary: the aim of this study is to compare the safety and effectiveness between two bdde-crosslinked hyaluronate, hyajoint plus and durolane, for the treatment of knee osteoarthritis pain.


Eligibility criteria:
inclusion criteria: 1. age from 35 to 85 years; 2. radiographic kellgren-lawrence grade ii to iii; 3. symptoms ≧6 months despite conservative treatments such as analgesics, nsaid and/or physical therapy; 4. average knee pain score ≧30mm on 100-mm visual analog scale (vas) in recent one week; 5. radiographic evidence of bilateral knee oa not reason for exclusion if vas pain in contralateral knee \<30mm. exclusion criteria: 1. previous orthopedic surgery in the lower extremity; 2. disabling osteoarthritis of hip or ankle; 3. previous iaha within 6 months; 4. ia steroid or joint puncture within 3 months; 5. characters of severe acute synovitis under ultrasound (us) examination, such as grade 3 in suprapatellar synovitis (sps), suprapatellar effusion (spe), medial compartment synovitis (mcs) or lateral compartment synovitis (lcs); 6. any specific medical condition, such as rheumatoid arthritis, lupus erythematous, hemiparesis, infection, neoplasm, and etc., that would interfere with assessments; 7. confirmed or suspected pregnancy or lactating; 8. known allergy history to any avian protein or ha product.

Keywords: osteoarthritis synovial fluid supplement hyaluronic acid
tolvaptan for ascites in cirrhotic patients

Conditions: Ascites; Cirrhosis

Summary: open label study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. tolvaptan will be administered in combination with current ascites management.

this is an open label, 12 week dose escalating pilot study of tolvaptan (initiating at 15 mg a day and increasing to 30 mg a day as tolerated in addition to standard ascites treatment) of 10 cirrhotic subjects meeting all inclusion/exclusion criteria. subjects are monitored for changes in frequency of paracentesis, quantity of ascites removed, and body weight. additionally, subjects laboratory values were checked frequently during the first days of dosing to ensure tolerability and slow correction/increase in serum sodium.

Eligibility criteria:
inclusion criteria: * patients with cirrhosis of liver confirmed by histology and/or combination of ultrasound or endoscopic examination with laboratory evidence * clinically evident ascites treated by diet and/or diuretics * history of 1 or more therapeutic paracentesis in the previous 6 months. exclusion criteria: * history of variceal bleeding * current or history of gastrointestinal bleeding within 10 days of screening * ascites from another cause other than liver cirrhosis (i.e. cardiac origin, peritoneal infection, or peritoneal carcinoma) * inr (international normalized ratio) \> 3.0, neutrophils \<1500 cell/μl, platelets \< 40,000/μl * serum bilirubin \> 3 mg/dl * serum sodium \< 125 meq (milliequivalent)/l * serum potassium \<3.5 meq/l

Keywords: cirrhotic tolvaptan v2 receptor antagonist
a study evaluating toripalimab injection combined with standard chemotherapy as a first-line treatment for locally advanced or metastatic urothelial carcinoma

Conditions: Locally Advanced or Metastatic Urothelial Carcinoma

Summary: the study is being conducted to evaluate the efficacy and safety of toripalimab injection in combination with chemotherapy compared to placebo in combination with chemotherapy in subjects with pd-l1-positive unresectable locally advanced or metastatic urothelial carcinoma who have received no previous systemic therapy.


Eligibility criteria:
inclusion criteria 1. have full knowledge on this study and are willing to sign informed consent form (icf); 2. age 18-75 years at time of signing icf, male or female; 3. the investigator judged that the subject is eligible for platinum-based chemotherapy; 4. presence of histopathologically confirmed unresectable locally advanced (t4, any n; or any t, n2-3) or metastatic urothelial carcinoma; 5. no prior systemic anti-tumor therapy; 6. subjects who are able to provide tumor tissue slides (≥ 5 slides) for pd-l1 test and the corresponding pathology report and whose pd-l1 test must be positive before randomization; 7. with at least one measurable lesion as per recist 1.1 criteria; 8. ecog performance status score of 0-1; 9. adequate function of vital organs. exclusion criteria 1. have received anti-tumor treatments, including chemotherapy, radiotherapy or investigational product within 28 days before randomization; 2. have received traditional chinese medicines with anti-tumor activity or immunomodulators (eg. interferon and interleukin) within 14 days before randomization; 3. previous use of anti-pd-1/pd-l1 agent or a drug acting on another co-inhibitory t cell receptor; 4. subjects who are currently participating in or have participated in a study with investigational product within 4 weeks before administration; 5. having received systemic corticosteroid therapy (dose equivalent to prednisone \> 10 mg/day) within 14 days before randomization; 6. subjects with active central nervous system (cns) metastasis; 7. grade 2 or higher peripheral neuropathy or hearing loss.
factors associated with dermatoporosis

Conditions: Senile Purpura

Summary: dermatoporosis is a chronic syndrome of skin insufficiency or fragility. it is characterized by cutaneous atrophy, senile purpura and stellate pseudoscars. dermatoporosis prevalence is 37% in ≥65 years. the objective was to determine factors associated with this diagnosis in \>60 years old patients of the outpatient clinic in the hospital central "dr. ignacio morones prieto " san luis potosí, méxico. an observational, cross-sectional, descriptive, and analytical study was performed. patients \>60 years old were selected. a clinical history, clinical examination, and application of a validated diagnostic self-questionnaire were performed.

dermatoporosis is a chronic syndrome of skin insufficiency or fragility. it is characterized by cutaneous atrophy, senile purpura and stellate pseudoscars. dermatoporosis prevalence is 37% in ≥65 years.the objective was to determine factors associated with this diagnosis in \>60 years old patients of the outpatient clinic in the hospital central "dr. ignacio morones prieto " san luis potosí, méxico. an observational, cross-sectional, descriptive and analytical study was performed. through consecutive non-probabilistic sampling, patients \> 60 years old were selected, who underwent a clinical history, clinical examination, and the application of a validated diagnostic self-questionnaire. to determine the association of the factors, a multivariate logistic regression analysis, it will be used the primerv6 software with the permanova package. a p \<0.05 was considered significant. the normality of the distribution of the continuous variables was evaluated with the shapiro wilk test. the student's t test was performed on variables that met the homogeneity of variance requirements. in the variables that did not meet this criterion, a non-parametric analysis was performed with the mann u whitney test. for the analysis of categorical variables, fisher's exact test or chi-square test was used. continuous variables were reported by mean (median) \[q1, q3\] (min - max) and by standard deviations as their distribution corresponds. nominal categorical variables were expressed as frequencies

Eligibility criteria:
inclusion criteria: * patients over 60 years exclusion criteria: * patients in whom physical examination cannot be performed due to the use of orthopedic devices such as splints, bandages, etc. * patients with whom interviewer-patient verbal communication is difficult due to some hearing or neurological deficit. * patients with neurological, psychiatric disorders who are unable to provide reliable information. (disorganized, incoherent speech, cognitive deficit)

Keywords: dermatoporosis senile purpura
medical icu paper-based dynamic insulin protocol

Conditions: Stress Hyperglycemia

Summary: intensive care unit (icu) patients commonly display hyperglycemia, even without previously known diabetes. it was demonstrated that hyperglycemia was associated with increased hospital mortality in various medical and surgical icu situations. however, discrepant results from recent randomized, clinical trials of tight blood glucose control in icus have not allowed conclusions regarding whether there is a causal link between hyperglycemia and icu mortality. in addition to the mean blood glucose level, glucose variability has recently been emphasized as an independent predictor of icu and hospital mortality. this concept has been described in a wide variety of medical, surgical and trauma icu patients. in all of these settings, glycemic variability was measured with various indices but was steadily associated with icu and/or hospital mortality in non-diabetic icu patients. conversely, glycemic variability was either weakly or not associated with mortality in icu patients with previously known diabetes. notably, all of these data have been observational, and interventional trials remain lacking to assess the impact of glycemic variability reduction on icu mortality and thus to demonstrate causality. however, glycemic variability was considered sufficiently important to be mentioned in recent international guidelines for the management of hyperglycemia in critically ill patients. in these publications, experts from the american college of critical care medicine emphasized that glycemia should be maintained at less than 9.9 mmol/l in icu patients while avoiding hypoglycemia and minimizing glycemic variability. to achieve these goals, computer-based insulin infusion protocols have demonstrated their superiority to paper-based protocols. glucose concentrations, variation per unit of time between the last and current glucose measurements, insulin dosage, and carbohydrate intake were the main input variables used in these different computerized algorithms. however, such protocols are not widely available because commercial systems have licensing fees and academic protocols do not always go beyond the pilot phase. to address this issue, the investigators adapted a previously validated, paper-based, dynamic protocol (dp) to an actual recommended glycemic target range. our aim was to assess the efficacy, safety, feasibility and acceptance by nurses of this dynamic insulin protocol, compared to a paper-based, sliding scale static protocol (sp).


Eligibility criteria:
inclusion criteria: * male or female adult patient admitted to intensive care unit * intensive care unit stay \> 48 hours * stress hyperglycemia above 9.9 mmil/l indicating the need of continuous intravenous insulin infusion exclusion criteria: * previous diabetes * acute metabolic event (ketoacidosis or hyperosmolarity) * insulin/dextrose infusion for hyperkalemia treatment
effect of bovine colostrum on toxicity and inflammatory responses

Conditions: Acute Lymphoblastic Leukemia

Summary: the aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation in children treated for acute lymphoblastic leukemia.

acute lymphoblastic leukaemia (all) is the most common form of childhood cancers. cure rates are improving, but the intensity of treatment is limited by toxicity. 2-5% of patients die of treatment related complications, mostly related to therapy-induced toxicity and immune suppression. the aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation. the study is based on patients treated according to the current nopho protocol.

Eligibility criteria:
inclusion criteria: * patients treated according to the nordic society of pediatric haematology and oncology (nopho) all protocol exclusion criteria: * milk allergy * lactose intolerance

Keywords: acute lymphoblastic leukemia bovine colostrum inflammation infection toxicity
a study of subcutaneous mircera for the maintenance treatment of dialysis patients with chronic renal anemia.

Conditions: Anemia

Summary: this 2 arm study will compare the efficacy and safety of monthly administration of subcutaneous mircera versus epoetin alfa for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. patients currently receiving maintenance treatment with epoetin alfa will be randomized to receive either monthly injections of mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic renal anemia; * regular hemodialysis with the same schedule of dialysis for \>=12 weeks; * maintenance therapy with subcutaneous epoetin alfa at the same administration interval for 4 weeks. exclusion criteria: * transfusion of red blood cells during previous 2 months; * poorly controlled hypertension requiring interruption of epoetin alfa in previous 6 months; * acute or chronic bleeding; * active malignant disease (except non-melanoma skin cancer).
postoperative analgesia with buprenorphine for postoperative pain control and quality of life after spinal surgery

Conditions: Spinal Stenosis; Pain, Postoperative

Summary: major purpose of this research is to evaluate the effect and usefulness of buprenorphine transdermal system (mtds) among the patients with lumbar spinal disease who was performed the single-level posterior lumbar fusion. after surgery, all the patients apply the patient-controlled analgesia. after three days of surgery, patients are divided into two groups.group a is an experimental group that administer the btds after surgery, and group b is a control group that take tramadol analgesics. if the patient's pain score exceeds the nrs 4, they can take the additional rescue medicine, acetaminophen. after the surgery, patient's pain score and quality of life would be recorded sequentially. the time of recording is postoperative 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months, respectively.


Eligibility criteria:
inclusion criteria: * adults over 20 years * taking the lumbar spinal surgery : single-level, posterior fusion * stay in hospital more than 2 days after operation exclusion criteria: * pregnancy or breast-feeding * allergy or contraindication to buprenorphine * patient with decreased lung function * patient with taking mao inhibitor or anticonvulsant * patient with brain lesion, or severe liver disease * dependence in opioid drugs * taking muscle relaxant or tranquilizer * patient had taken buprenorphine preoperatively * taking strong opioids before enrolling the study * another severe source of pain except lumbar spine * severe cardiovascular, pulmonary, or renal compromised patients

Keywords: buprenorphine transdermal system pain, postoperative quality of life spinal stenosis posterior lumbar fusion
magnesium effect on embryonal pr interval

Conditions: Preterm Labor

Summary: magnesium is a known treatment for neuroprotection in preterm labor before 32 week of gestation. high concentration of magnesium in the blood stream known as cause of conduction abnormalities and ecg changes such us prolonged qt, qrs and pr in about. the goal of our work is to evaluate the pr intervals in embryos after maternal treatment with magnesium during preterm labor.

we will recruit 25 woman with threaten preterm labor, magnesium blood level and pr interval will be evaluated before magnesium loading dose (4gr) and 20 minutes after the loading dose. pr interval will be evaluated by mitral-aorta doppler.

Eligibility criteria:
inclusion criteria: * women at risk for preterm labor before 32 week of gestation exclusion criteria: * fetal malformations * maternal lupus * fetal conduction abnormalities
safe and timely antithrombotic removal - direct oral anticoagulants apixaban & rivaroxaban (star-d)

Conditions: Hemorrhage, Surgical; Hemorrhage Postoperative; Blood Loss, Surgical; Blood Loss, Postoperative

Summary: prospective, multicenter, double-blind, randomized, study to evaluate drugsorb-atr removal of apixaban and rivaroxaban to reduce likelihood of serious bleeding in patients undergoing urgent cardiothoracic surgery

the safe and timely antithrombotic removal - direct oral anticoagulants (doacs) apixaban \& rivaroxaban (star-d) study is a prospective, multicenter, double-blind, randomized study that evaluated the drugsorb™-antithrombotic removal (atr) device for removal of apixaban and rivaroxaban to reduce the likelihood of serious bleeding in patients undergoing urgent cardiothoracic surgery. the objectives were * to demonstrate reductions in surgical and early post-surgical bleeding with the intraoperative use of drugsorb-atr in patients undergoing cardiothoracic surgery ≤36hrs since last apixaban or rivaroxaban dose. * to demonstrate reductions in apixaban or rivaroxaban blood levels (δ\[doac\]) with the intraoperative use of drugsorb-atr. * to establish the safety of the intraoperative use of drugsorb-atr in the intended population.

Eligibility criteria:
inclusion criteria: 1. male or female age 18 years or older, with documented full, written informed consent 2. requiring cardiothoracic (ct) surgery with cardiopulmonary bypass (cpb) within 36 hours from last dose of either apixaban or rivaroxaban (\*note that patients must be taking apixaban or rivaroxaban for one of the following indications: a) reduction of stroke/systemic embolism in nonvalvular atrial fibrillation, or b) initial or extended treatment of venous thromboembolism) exclusion criteria: 1. \>48hrs between last apixaban or rivaroxaban dose and start of ct surgery 2. patients on low dose apixaban or rivaroxaban for prophylactic indications 3. heart-lung transplant procedures 4. procedures for ventricular assist device (i.e., implant or revision of left ventricular assist device \[lvad\] or right ventricular assist device \[rvad\]) 5. any of the below conditions that pose a known risk for increased bleeding 1. heparin induced thrombocytopenia 2. preoperative platelet count \<50,000u/l 3. hemophilia 4. international normalized ratio (inr) greater than or equal to 1.8 6. prohibited concomitant antithrombotic medications as defined in the study protocol 7. acute sickle cell crisis 8. known allergy to device components 9. active (untreated) systemic infection 10. history of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed 11. women with positive pregnancy test during current admission or who are breast-feeding 12. life expectancy \<30 days 13. inability to comply with requirements of the study protocol 14. treatment with investigational drug or device within 30 days of current surgery 15. previous enrollment in this trial
in clinic optometrist insertion of dextenza prior to cataract surgery

Conditions: Cataract

Summary: to evaluate the clinical outcomes with optometrist pre-surgical insertion of dextenza in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older, undergoing routine, uncomplicated, sequential bilateral cataract surgery. * willing and able to comply with clinic visits and study related procedures * willing and able to sign the informed consent form exclusion criteria: * patients under the age of 18. * patients who are pregnant (must be ruled out in women of childbearing age with pregnancy test). * active infectious ocular or systemic disease. * patients with active infectious ocular or extraocular disease. * patients actively treated with local or systemic immunosuppression including systemic corticosteroids. * patients with known hypersensitivity to dexamethasone. * patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator. * patients with proliferative diabetic retinopathy or uncontrolled diabetes as deemed by an a1c \> 10.0. * patients with a history of ocular inflammation or macular edema. * patients with a pre-existing epiretinal membrane (erm) * patients with allergy or inability to receive intracameral antibiotic. * patients on systemic non-steroidal anti-inflammatory drugs (nsaid) greater than 1,200 mg/day the prepare study (v1) february, 2021 page 27 confidential * patients with a corticosteroid implant (i.e. ozurdex).
evaluation of post-induction hypotension treatment with pram method

Conditions: Hypotension on Induction

Summary: the goal of this observational study is to compare post-induction hypotension treatments with pram method in gynecologic oncological cases. the goal of this observational study is to compare post-induction hypotension treatments with pram method in gynecologic oncological cases.

post-induction hypotension is defined as hypotension that occurs within the first 20-30 minutes after general anesthesia induction or during the period between anesthesia induction and surgical incision. the global incidence rates are reported to be approximately 10.3%, with some studies indicating rates as high as 66.96%. post-induction hypotension is associated with increased postoperative morbidity risks, such as acute kidney injury, transient tubular dysfunction, myocardial injury, and the need for postoperative intensive care. however, hypotension is a modifiable and preventable risk factor; its early detection and appropriate treatment can improve patient outcomes. for this reason, investigators aimed to investigate the repeated dose requirements of alpha-adrenergic drugs, the recurrence of hypotension, and their effects on parameters observed via the mostcare monitor in patients undergoing major gynecologic oncologic surgeries during standard anesthesia induction and maintenance. this investigation focuses on patients experiencing a mean arterial pressure \ 30% reduction in baseline systolic blood pressure within the first 30 minutes after induction or until surgical incision. additionally, our secondary aim is to examine other parameters that may be associated with post-induction hypotension.

Eligibility criteria:
inclusion criteria: * above 18 years old * operated for gynecologic oncological reasons * bmi\<35 exclusion criteria: * refusal to participate in the study * additional spinal or epidural anesthesia * dementia patients from whom consent could not be obtained * atrial fibrillation with a rapid ventricular response * patients with difficult ventilation and/or difficult intubation * left ventricular ejection fraction (ef) below 30% * severe aortic valve stenosis * obesity (bmi \>35) * chronic beta-blocker use

Keywords: post-induction hypotension pram ephedrine noradrenaline