Kornimate/medical-research-clean huggingface dataset:
clinical study of hr091506 tablets in treatment of gout with hyperuricemia in adults

Conditions: Gout With Hyperuricemia in Adults

Summary: the study is being conducted to evaluate the efficacy, and safety of hr091506 tablets for treatment of gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.


Eligibility criteria:
inclusion criteria: 1. 18-75 years old, male or female; 2. bmi: 18.0-30.0 kg/m2; 3. meet the 2015 acr/eular gout classification criteria; 4. fast serum uric acid ≥ 480 μmol/l on 2 different days during the screening perid; 5. willing to ues contraceptive measures during the study; 6. able and willing to provide a written informed consent. exclusion criteria: 1. history of acute gout attack within 4 weeks before randomization. 2. subjects who have undergone major surgery or organ transplantation within 3 months before randomization. 3. subjects with major cardiovascular disease within 6 months before randomization. 4. history of chronic infection or recurrent infection within 1year before randomization. 5. history of malignant tumor or current history of combined malignant tumor within 5 years before screening. 6. history of secondary hyperuricemia, refractory gout, or xanthine metabolism disorder. 7. subjects with poorly controlled blood pressure or diabetes mellitus. 8. history of chronic diffuse connective tissue disease and/or massively elevated urate diseases and/or untreated clinically significant thyroid disease. 9. history of diseases that may affect the in vivo process, safety evaluation, or subjects' participation in the research. 10. abnormal laboratory tests that may affect subjects participating in the research. 11. combined use of prohibited drugs. 12. allergic to ingredient or component of the experimental drug. 13. participated in other clinical trials within 1 month before randomization. 14. pregnant or nursing women. 15. history of drug abuse, drug use and/or excessive drinking within 1 year before screening. 16. the inestigators determined that other conditions were inappropriate for participation in this clinical trial.
lumbar stabilization exercises in adult patients with lumbar arthrodesis surgery

Conditions: Arthrosis; Spine; Spinal Stenosis Lumbar

Summary: the purpose of this study is to determine which type of lumbar stabilization exercise is more effective to improve functionality and reduce pain in patients operated with lumbar arthrodesis, to guide clinical practice in the rehabilitation of these patients.

the objective of this study is to determine which exercise modality (global, local or mixed) is most effective in reducing pain and improving function at 6 and 12 weeks after the operation. the methodology will be a randomized experimental clinical trial. the study population will be subjects who underwent surgery for lumbar spinal stenosis due to decompression and posterolateral fusion. the estimation of the sample size was made on the basis of the anova test measures, following the guidelines established by stevens, for which an α = 0.05 and β = 0.2 were used, power = 80% and moderate effect size. as a result, the program (gpower) gave us a total sample size of 24 subjects, so we will use a sample of 30 subjects due to the possibility of departure of some of them abandoning during the process. the sample will be taken from a waiting list of lumbar spinal stenosis surgery at the traumatological institute of santiago (it). to measure the level of functionality, we will use the oswestry disability index 2.0 in spanish, and for pain, the visual analogue scale, in addition to recording general data. for each instrument, 3 measurements will be taken: preoperative, 6 and 12 weeks after the operation. to analyze the data, the program of the latest version of ibm spss statistics base will be used, a shapiro wilks normality test will be performed to confirm a normal distribution and then an anova of repeated measures to confirm the hypothesis.

Eligibility criteria:
inclusion criteria: * patients aged over 18 years old, operated of lumbar spine arthrodesis for degenerative spinal stenosis at traumatological institute of santiago de chile exclusion criteria: * overweight * underweight * previous surgeries * postoperative complications * higher pain in lower limbs than in low back * inability to exercise

Keywords: arthrodesis core stabilization physical therapy
the effect of telerehabilitation-based exercise and training on outcome measures in patients with knee osteoarthritis

Conditions: Osteoarthritis; Knee Arthritis

Summary: video exercise component of the telerehabilitation would provide additional contribution to the patients. the aim of this study is to compare the effects of telerehabilitation-based exercise program and conventional (given on paper) exercise and training combination practices on pain, functionality, balance, proprioception and quality of life in patients with knee oa.

owing to telerehabilitation, exercise video suppliment will enable individuals to learn the exercise programs in the most appropriate way, have comprehensive information about their condition, and communicate easily with their physiotherapists. the aim of this study is to compare the effects of telerehabilitation-based exercise program and conventional (given on paper) exercise and training combination practices on pain, functionality, balance, proprioception and quality of life in patients with knee oa.

Eligibility criteria:
inclusion criteria: * patients aged between 40 to 65 years * being diagnosed with knee osteoarthritis by an orthopedist * having a value of 1 or 2 in the kellgren lawrence classification * having and being able to use the equipment to receive video-based exercise and education support * having signed the consent form exclusion criteria: * situations that will prevent assessments or communication with the individual * knee surgery history * having other joint pathologies * orthopedic and neurological problems that would prevent evaluation and/or treatment

Keywords: gonarthrosis knee osteoarthritis
ai-powered scoliosis auto-analysis system multicenter development and validations

Conditions: Spinal Deformity

Summary: the investigators aim to use artificial intelligence (ai) to help clinicians in diagnosing and assessing spinal deformities.

background spinal deformity is a prevalent spinal disorder in both paediatric and adult populations. the spine alignment need to be quantitively assessed for further treatment planning. however, the current practice requires spine surgeons to manually place landmarks of endplates and key vertebrae. the process is laborious and prone to inter- and intra-rater variance. thus, the investigators have developed an ai-powered spine alignment assessment system (alignprocare) to facilitate clinicians in fast, accurate and consistent analytical results. the investigators aim to test and improve the performance of the spine alignment auto-analysis in all patients with spinal deformities in multiple centers including malaysia, china, and japan objectives: 1. prospectively test the alignment assessment of patients' spinal deformities with whole spine x-rays (both pa and lateral) and nude back image with the assessment via alignprocare. 2. collect 500 labeled deformity radiographs and nude back images in both pa and lateral views per center. 150 patients need to be followed up with radiographs and nude back photos collected (all parameters measured again). 3. use transfer learning to update the current alignprocare for scoliosis analysis to form alignprocare+. 4 qualitatively analyse the alignprocare+ using an independent dataset.

Eligibility criteria:
inclusion criteria: * idiopathic scoliosis, adult deformity (spondylolisthesis, idiopathic kyphosis, kyphoscoliosis, lordoscoliosis) exclusion criteria: * refusal for imaging, postoperative patients

Keywords: adult deformity, scoliosis, spondylolisthesis
efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and diabetic kidney disease

Conditions: Chronic Kidney Disease

Summary: the primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (egfr) ≥40% from baseline over at least 4 weeks, or renal death.


Eligibility criteria:
inclusion criteria: * men or women ≥18 years of age * type 2 diabetes mellitus (t2d) as defined by the american diabetes association * diagnosis of chronic kidney disease (ckd) with at least one of the following criteria at run-in and screening visits: * persistent high albuminuria (uacr ≥30 to \<300 mg/g in 2 out of 3 first morning void samples) and estimated glomerular filtration rate (egfr) ≥25 but \<60 ml/min/1.73 m² (ckd epi) and presence of diabetic retinopathy or * persistent very high albuminuria (uacr ≥300 mg/g in 2 out of 3 first morning void samples) and egfr ≥25 to \<75 ml/min/1.73 m² (ckd-epi) * prior treatment with angiotensin-converting enzyme inhibitors (aceis) and angiotensin receptor blockers (arbs) as follows: * for at least 4 weeks prior to the run-in visit, subjects should be treated with either an acei or arb, or both * starting with the run-in visit, subjects should be treated with only an acei or arb * for at least 4 weeks prior to the screening visit, subjects should be treated with the maximum tolerated labeled dose (but not below the minimal labeled dose) of only an acei or an arb (not both) preferably without any adjustments to dose or choice of agent or to any other antihypertensive or antiglycemic treatment * serum potassium ≤4.8 mmol/l at both the run-in and the screening visit exclusion criteria: * known significant non-diabetic renal disease, including clinically relevant renal artery stenosis * uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (sbp) ≥170 mmhg, sitting diastolic blood pressure (dbp) ≥110 mmhg at run-in visit, or mean sitting sbp ≥160 mmhg, sitting dbp ≥100 mmhg at screening) * glycated hemoglobin (hba1c) \>12% * mean sbp \< 90 mmhg at the run-in visit or at the screening visit * clinical diagnosis of chronic heart failure with reduced ejection fraction (hfref) and persistent symptoms (new york heart association \[nyha\] class ii - iv) at run-in visit (class 1a recommendation for mineralcorticoid receptor antagonists \[mras\]) * stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the screening visit * dialysis for acute renal failure within 12 weeks of run-in visit * renal allograft in place or scheduled within next 12 months from the run-in visit

Keywords: ckd diabetic kidney disease type 2 diabetes kidney diseases
neural glides with and without therapeutic ultra sound on in pregnant computer workers with carpal tunnel syndrome

Conditions: Pregnancy Related

Summary: to study the effects of neural glides with and without using therapeutic ultrasound and functional status in pregnant computer workers with cts

carpal tunnel syndrome is a median nerve compression and results in significant discomfort and pain, daily living activity limitation, loss of sleep and work disability. carpal tunnel syndrome is more common in pregnancy because in pregnancy prolactin hormone increase the fluid retention in extra capsule and results in soft tissue swelling. several therapeutically treatments have been advocated for the carpal tunnel syndrome including mobilizations, nerve gliding, tendon gliding, ultrasound, icing, massaging. women experience pregnancy several times, and if they acquire carpal tunnel syndrome, invasive treatments cannot be used, the probability of reoccurrence of carpal tunnel syndrome in the next pregnancy with higher intensity. use of non-invasive treatment methods are more beneficial. carpal tunnel syndrome very common nowadays as most of the population is involved in computer work by some means especially the computer working ladies who always use the conventional mouse and key board for their work. pregnant women diagnosed with carpal tunnel syndrome and are computer working would be selected for this study. diagnostic criteria would be positive tinel's and phalen's. the subjects will be divided into two groups. group a (experimental) and group b (control). group a will perform with nerve glides with therapeutic ultrasound. the control group does only exercise program (tendon and nerve gliding exercises). both groups are assessed by outcome measures pre and post interventions. pain symptoms is measured with the help of visual analogue scale, the boston carpal tunnel questionnaire form will administer for the patient evaluation functional status scale and symptom severity scale.

Eligibility criteria:
inclusion criteria: third trimester tinel's sign positive phalen test positive pregnant women with pain and numbness in wrist and fingers women with tingling sensation in the wrist nocturnal parasthesia in wrist and fingers exclusion criteria: inflammatory joint disease age above 35 years wrist bone fractures hand surgery diabetes gout autoimmune disease person with rheumatoid arthritis any other abnormalities

Keywords: cts functional status scale non invasive methods
anesthetic effect of lidocaine/epinephrine solution delivered via iontophoresis to external auditory apparatus

Conditions: Acute Otitis Media; Chronic Otitis Media; Recurrent Acute Otitis Media

Summary: this is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provision of tympanic membrane anesthesia in patients who are indicated for an ear procedure requiring penetration of the tympanic membrane, including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube placement.


Eligibility criteria:
inclusion criteria: 1. age 12 months and older 2. both male and female patients eligible 3. patients are indicated for procedures requiring penetration of the tympanic membrane (including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube implant) exclusion criteria: 1. patients with a history of sensitivity or reaction to lidocaine, epinephrine or any hypersensitivity to local anesthetics of the amide type or any component of the drug solution 2. markedly atrophic, retracted, atelectatic or perforated tympanic membrane 3. otitis externa 4. electrically sensitive patients and patients with electrically sensitive support systems (pacemakers, defibrillators, etc.) 5. damaged or denuded skin in the auditory canal 6. cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
antithrombin iii and post-liver transplantation acute kidney injury

Conditions: Liver Transplantation and Antithrombin

Summary: the reno-protective effect of antithrombin iii (atiii) has been well-studied in various animal studies; however, little is known about the effect of atiii on kidney function in patients undergoing liver transplantation (lt). this study aimed to determine the association between preoperative atiii level and postoperative acute kidney injury (aki) after lt (post-lt aki).


Eligibility criteria:
inclusion criteria: * patients who underwent either living- or deceased-donor lt (ldlt, ddlt) from january 2010 to january 2018 exclusion criteria: * patients who underwent re-transplantation * patients who were previously diagnosed with end-stage renal disease or chronic kidney disease * patients who were being treated with continuous renal replacement therapy * preoperative or postoperative antithrombin iii levels were not available

Keywords: acute kidney injury antithrombins liver transplantation
association between genetic variant scores and doacs (dares2)

Conditions: Drug-Related Side Effects and Adverse Reactions; Iatrogenic Disorder

Summary: the study's objective is to evaluate the predictive accuracy of cipherome's algorithm in predicting and preventing serious adverse drug reactions (adrs) experienced by patients while on direct oral anti-coagulants (doacs).


Eligibility criteria:
inclusion criteria: * any adult patient 18 years and older, who experienced a serious adverse drug reaction while taking a doac and is able to provide informed consent. exclusion criteria: * failure to provide informed consent
assess the efficacy and safety of rhinocort aqua

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to compare rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.


Eligibility criteria:
inclusion criteria: * in the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids. * a documented history of allergic rhinitis and a positive response to a skin prick test at visit 1 or within the last 12 months for allergens that must be present in the subject's environment for the duration of the study. * at randomisation having nasal symptom scores as defined by the protocol. exclusion criteria: * primary or secondary adrenal insufficiency * nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator. * a diagnosis of asthma requiring treatment as specifies in the protocol.

Keywords: allergic rhinitis paediatric nasal symptoms congestion rhinorrhea sneeze budesonide rhinocort aqua
the risks of percutaneous native kidney biopsy in italy: a prospective cohort study

Conditions: Kidney Diseases

Summary: the estimates risks and benefits of the percutaneous kidney biopsy have been reported mainly from retrospective studies. so far no prospective multicentre studies has been designed to identify rates of biopsy related complications. the aim of this prospective multicentre study was to evaluate safety and complication events related to biopsies on native kidney in italy.

kidney biopsies performed in 54 italian nephrology centres from 2012 to 2020 were included. primary outcome of the study was any major complication, such as haemoglobin decrease more than 2 g/dl, macroematuria, gross ematoma, blood transfusion, artero-venous fistula, invasive intervention, pain, symptomatic hypotension, and/or rapid serum creatinine increase. centre and individual patient risk predictors were analysed using multivariate logistic regression analysis.

Eligibility criteria:
inclusion criteria: * adult or pediatric patients with a kidney disease * informed consent exclusion criteria: * patient with a transplanted kidney
study on the pharmacokinetics and safety of ql1012d and gonal-f® in healthy female volunteers

Conditions: Infertility, Female

Summary: the goal of this interventional study is to compare the pharmacokinetics and safety of recombinant human follicle stimulating hormone injection (ql1012d) and gonal-f® in healthy female volunteers. it aims to evaluate the bioequivalence of recombinant human follicle stimulating hormone injection (ql1012d) and gonal-f®, both given subcutaneously.


Eligibility criteria:
inclusion criteria: * female, age between 18 to 45 years (inclusive). * body mass index (bmi) of ≥18 and ≤28 kg/m2, body weight ≥45 kg. * with a history of sexual activity * regular menstruation cycle (25 to 35 days, inclusive). * normal sex hormone levels, or abnormalities deemed clinically insignificant by the investigator. * reached the standard within the time window after receiving the down-regulated drug. * agreed to take effective contraceptive measures during and 6 months after the end of the study period. * willing to participate in this clinical trial, understanding the study procedures, and able to provide written informed consent. exclusion criteria: * history of ovarian hyperstimulation syndrome, or polycystic ovary syndrome, or ovarian enlargement or cysts not caused by polycystic ovary syndrome, or primary ovarian failure; history of hypothalamic or pituitary tumors; history of malignancy; history of thrombosis; or other diseases that considered to influence the study by the investigator. * unexplained reproductive tract bleeding. * thin-layer cytology examination deemed clinically significant by the investigator. * vital signs, physical examination, 12-lead electrocardiogram, or laboratory examination deemed clinically significant by the investigator with. * pregnancy or lactation period, or positive human chorionic gonadotropin (hcg) examination. * known to be allergic to follicle-stimulating hormone (fsh), or gonadotropin-releasing hormone agonists (gnrh-a) or their analogs * consume strong coffee or tea daily * historic abuse of alcoholic beverages * smoke ≥5 cigarettes per day within 3 months prior to the study * history of drug abuse * unsuitable for participation by the investigator.
cannabidiol as an adjunctive treatment for bipolar depression

Conditions: Bipolar Disorder; Bipolar Depression; Bipolar Affective Disorder

Summary: depressive symptoms are associated with significant psychosocial impairment. however, current treatments of bipolar depression are only partially effective. cannabidiol is a natural component of cannabis without psychotomimetic or addictive properties. cannabidiol has been shown to produce therapeutic effects including anticonvulsive, anxiolytic, antipsychotic and neuroprotective effects. the investigators hypothesize that treatment with cannabidiol will result in improvement of depressive and anxiety symptoms, as well as, improvement in functioning and inflammatory biomarkers. during the clinical trial, subjects will receive study medication (cannabidiol 150-300mg/day) or placebo for a period of 12 weeks.


Eligibility criteria:
inclusion criteria: * major depressive episode as part of bipolar i disorder or bipolar ii disorder according to fifth edition of diagnostic and statistical manual for mental disorders (dsm-5) and are able to provide written informed consent. * montgomery-asberg depression rating scale (madrs) score ≥ 12 and madrs items 1 (apparent sadness) and 2 (reported sadness) scores ≥ 2 at baseline. * young mania rating scale (ymrs) ≤ 11. * currently prescribed lithium or valproic acid and derivates (divalproex sodium, sodium valproate) or atypical antipsychotics at therapeutic dosage for at least 04 weeks before the baseline. * females must test negative for pregnancy and must be using adequate birth control measures throughout the study. exclusion criteria: * another concurrent mental or behavioral disorder that requires psychiatric attention in the past 6 months. * young mania rating scale (ymrs) score \> 12. * current or past drug sensitivity/intolerance to cannabidiol. * substance use disorder according to dsm-5 within past 6 months, except for nicotine substance use disorder. * clinically significant unstable medical illness, neurological disorders or inflammatory/autoimmune diseases. * any autoimmune, inflammatory or neurologic disorders that requires treatment with steroidal anti-inflammatory medications or immunotherapy with biologic drugs. * actively suicidal or homicidal risk. * females who are pregnant or breastfeeding

Keywords: bipolar disorder bipolar depression cannabidiol endocannabinoids