Kornimate/medical-research-clean huggingface dataset:
assessing safety and efficacy of de-089 ophthalmic solution in patients with dry eye disease

Conditions: Dry Eye Disease

Summary: the objective of this study is to assess safety and efficacy of de-089 ophthalmic solution in patients with dry eye disease in taiwan.


Eligibility criteria:
inclusion criteria: * at least 6-month dry eye history exclusion criteria: * diagnosed with stevens-johnson syndrome or ocular pemphigoid * diagnosed with keratoconjunctival chemical burns or thermal burn * eye disease other than dry eye disease which needs treatment * allergic conjunctivitis that may possibly be aggravated during the clinical study and inappropriate for efficacy evaluation * those who need to wear contact lenses during the clinical study * those who are considered inappropriate for this study by the investigator or subinvestigators
cool vs room-temperature artificial tears

Conditions: Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis); Central Retinal Vein Occlusion With Macular Edema; Exudative Age-Related Macular Degeneration, Unspecified Eye; Cystoid Macular Edema; Ocular Surface Disease; Dry Eye Sensation; Eye Pain

Summary: background and objective: to evaluate the efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection (ivi) ocular discomfort. patients and methods: patients receiving ivi were randomized to either cooled or room temperature tears intervention groups. both groups rated their ocular discomfort following ivi before intervention and again after administration of cooled or room temperature tears.


Eligibility criteria:
inclusion criteria: * patients were eligible if they were receiving standard intravitreal injections for their exudative age-related macular degeneration, cystoid macular edema, diabetic macular edema, proliferative diabetic retinopathy, retinal vein occlusion with macular edema, or retinal neovascularization. exclusion criteria: * inability or lack of willingness to participate in the study * active ocular infection including infectious uveitis * first time receiving intravitreal injection * those who reported never having ocular discomfort following intravitreal injections on the pre-injection questionnaire * less than 18 years of age
remission induction of primary biliary cholangitis-autoimmune hepatitis overlap syndrome

Conditions: Hepatitis, Autoimmune; Cholangitis; Liver Cirrhosis, Biliary; Cholestasis

Summary: biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents


Eligibility criteria:
inclusion criteria: * 1.patients aged 18-70 years; * 2.diagnosed with primary biliary cholangitis-autoimmune hepatitis overlap syndrome according to paris criteria, based on liver biopsy results obtained 3 months before screening; * 3.white blood cell count ≥2.5x10\^9/l or platelet count ≥50x10\^9/l at inclusion; * 4.agreed to participate in the trial, and assigned informed consent. exclusion criteria: * 1. the presence of hepatitis a, b, c, d, or e virus infection; * 2. patients with indications for immunosuppressive treatment at inclusion: serum alanine transaminase(alt) or aspartate transaminase(ast) ≥10 fold upper limit of normal(uln)，or serum alt or ast≥ 5 fold uln and γglobulin level ≥ 2 fold uln, or bridging necrosis or multiacinar necrosis on histological examination. * 3. patients with complications of cirrhosis; * 4. patients with previous treatment of immunosuppressive agents or traditional chinese medicine for more than one month; * 5. primary sclerosing cholangitis,non-alcoholic steatohepatitis,drug induced liver disease or wilson's disease confirmed by liver biopsy; * 6. pregnant and breeding women; * 7. severe disorders of other vital organs, such as severe heart failure, cancer; * 8. parenteral administration of blood or blood products within 6 months before screening; * 9. recent treatment with drugs having known liver toxicity; * 10.taken part in other clinic trials within 6 months before screening.
effect of diode laser on post-operative pain after endodontic treatment in teeth with apical periodontitis

Conditions: Apical Periodontitis; Postoperative Pain

Summary: aim: this study aims to assess the effect of root canal disinfection with a 980 µm diode laser following chemomechanical root canal preparation on the severity of pain after root canal treatment (rct). materials and methods: in present study, asymptomatic, single-rooted teeth with periapical index (pai) score 3 or 4 were included. all patients were treated with two visits of root canal treatment including dressing with calcium hydroxide. patients were randomly divided into two groups (n: 28). 'control (no laser)': the final irrigation was performed using 5ml 2.5% naoci, followed by 5 ml 17% edta and 5 ml distilled water. 'laser disinfection (ld)': root canals were irradiated with 980 µm diode laser after final irrigation at both visits. the pain levels were evaluated using visual analog scale (vas) after 8, 24, 48 hours and 7 days. in addition, analgesic intake and time intervals were recorded by patients. the collected data were statistically analyzed with the chi-square and mann-whitney u test (p\<0.05).


Eligibility criteria:
inclusion criteria: * healthy patients * patients that had asymptomatic, single-rooted teeth with pai score 3 or 4 exclusion criteria: * antibiotic use with in the last month, * anti-inflammatory analgesic use within the last five days, * systemic disorder, pregnancy or lactation, * traumatic occlusion, * presence of other teeth requiring rct, * teeth with root canal fillings, * calcified canals, * root resorption, * periodontal diseases, * sinus tracts * severe crown destruction preventing rubber-dam application

Keywords: diode laser irrigation post-operative pain root canal treatment visual analog scale
identification of neuropsychological, genetic and neuroimaging markers and treatment response predictors of adhd

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the objective of this study is to identification of neuropsychological, genetic and neuroimaging markers and treatment response predictors of attention-deficit/hyperactivity disorder (adhd). participants who take the standardized pharmacotherapy (methylphenidate or atomoxetine) for adhd will be observed for 52 weeks. they will do several neuropsychological, neuroimaging and genetic tests at visit 1\~6.


Eligibility criteria:
inclusion criteria: 1. aged between 6 and 12 years 2. met the diagnostic and statistical manual iv text revision (dsm-iv-tr) diagnostic criteria for adhd and needed pharmacotherapy. 3. informed consent exclusion criteria: 1. presence of intellectual disability or learning disorder 2. past and/or current history of bipolar disorder or psychosis or substance use disorder 3. past and/or current history of pervasive developmental disorder, organic mental disorder or other neurological disorder 4. presence of sever suicidal ideation 5. presence of tic disorder or obsessive-compulsive disorder whose symptoms needed pharmacotherapy 6. presence of family history with tourette's syndrome 7. took medication with methylphenidate or atomoxetine with last 6 month (or more than 3 month) 8. presence of severe medical condition (ex. cardiologic, liver, kidney, pulmonary, glaucoma) 9. took alpha 2 adrenergic receptor agonist, antidepressant, antipsychotics, benzodiazepine, modafinil, antiepileptic drug or dietary supplement that have a influence on central nervous system (cns). 10. presence of possibility with pregnancy 11. especially for neuroimaging, 1. uncooperative with claustrophobia or body movement 2. metal material inside body that can't take off

Keywords: neuropsychological neuroimaging genetic markers treatment response predictor
effects of mental practice for mobility in post-stroke hemiparesis

Conditions: Stroke; Hemiparesis

Summary: stroke is a neurovascular event characterized by impaired blood supply to the brain due to rupture or obstruction of certain cerebral arteries, which often results in hemiparesis and can affect individuals of any age and sex, being prevalent in the elderly population. among the main treatments available for stroke rehabilitation, most of them demands an appropriate structure and high-qualified personnel. searching for more affordable treatment options, several studies suggest the use of mental practice with motor imagery as a potential therapeutic tool, since it can be performed at any place or any time the patient wishes, including their own homes. motor imagery can be defined as the covert cognitive process of imagining a movement of your own body(-part) without actually moving that body(-part). within this context, the objective of this study is to investigate the effects of mental practice for mobility, gait function and speed and muscle strength of the lower limb in subacute post-stroke hemiparesis.

post-stroke patients will be invited to participate after hospital discharge, based on inclusion and exclusion criteria. then, after acceptance, participants will be randomized (block strategy) into two groups: control group (physiotherapy and cognitive mental exercise) and intervention group (physiotherapy and mental practice group). at baseline, 4 weeks (end of intervention) and 6 weeks, participants will be evaluated through the following tests: timed-up and go test, 5-meter walk test, tug-abs, whoqol-bref, dass-21 and muscle strength.

Eligibility criteria:
inclusion criteria: * hemiparesis after ischemic stroke (15 to 180 days after the event); * only one cerebral hemisphere affected; * no chemical, alcohol or drug dependency; * score average ≥ 2,5 point in the instrument "visual and kinesthetic imagery questionnaire" (kivq-10); * no cognitive impairment (18 points in the mini-mental state examination - 0-4 years of educations and 24 points (\>4 years of education); * not participating in any other type of physiotherapy or physical activity during the study period; * complaining of difficulty in gait and mobility after stroke; * able to stand up from a chair and walk some distance with or without auxiliary device; exclusion criteria: * hemorrhagic or ischemic progressing to hemorrhagic stroke; * score ≥ 4 on the visual analogue pain scale; * score ≥ 2 on the modificator ashworth scale; * visual disabilities; * severe aphasia; * cardiovascular instability and/or other neurological disorders that may impair the mobility and gait.

Keywords: mental practice motor imagery hemiparesis stroke gait mobility
pharmacokinetic comparison of all fk-506 formulations

Conditions: Renal Failure

Summary: the purpose of the study is to compare the pharmacokinetic parameters of three different formulations of tacrolimus. eligible patients will be treated with all three formulations in a pre-defined sequence.

the pharmacokinetic parameters t(max), c(max) and auc(0-24) will be compared between the three formulations envarsus xr once daily, astagraf xl once daily and prograf twice daily.

Eligibility criteria:
inclusion criteria: 1. renal transplant recipients, males or females, of 18 years of age or above. 2. able to participate and willing to give written informed consent and to comply with study visits and restrictions. 3. able to understand english. 4. patients having received a primary or secondary renal transplant exclusion criteria: 1. evidence of acute rejection episode within the past three months prior to screening. 2. recipients of organ transplants other than kidney. 3. patients who are known to be hiv positive.
evaluation of cardiac affections in patients with mucopolysaccharidosis (mps) in assuit university children hospital (auch)

Conditions: Mucopolysaccharidoses

Summary: this study aims to evaluate the different cardiac changes in the various types of mps disorder and define the outcome of these cardiac abnormalities in those patients admitted to assuit university children hospital

the mucopolysaccharidoses (mpss) are inherited lysosomal storage disorders caused by the absence of functional enzymes that contribute to the degradation of glycosaminoglycans (gags). the progressive systemic deposition of gags results in multi-organ system dysfunction that varies with the particular gag deposited and the specific enzyme mutation(s) present. cardiac involvement has been reported in all mps syndromes and is a common and early feature, particularly for those with mps i, ii, and vi. cardiac valve thickening, dysfunction (more severe for left-sided than for right-sided valves), and hypertrophy are commonly present; conduction abnormalities, coronary artery and other vascular involvement may also occur. cardiac disease emerges silently and contributes significantly to early mortality. the clinical examination of individuals with mps is often difficult due to physical and, sometimes, intellectual patient limitations. the absence of precordial murmurs does not exclude the presence of cardiac disease. echocardiography and electrocardiography are key diagnostic techniques for evaluation of valves, ventricular dimensions and function.

Eligibility criteria:
inclusion criteria: - all the patients at any age up to 18 years with any type of mps confirmed by the enzymatic assay exclusion criteria: * any patient other than mps
a study of hstc810 with advanced/metastatic solid tumors (stcube-001)

Conditions: Advanced Solid Tumor

Summary: the purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of hstc810 monotherapy in participants with advanced solid tumors.

the study consists of a dose-escalation phase that will evaluate 6 dosing schedules of hstc810. the first cohort will be single participant cohort. subsequent escalation cohorts will use a standard 3+3 design, with the ability to backfill up to an additional 6 patients in each dose cohort.

Eligibility criteria:
inclusion criteria: * male or female aged at 18 ≥ years * capable and willing to give signed informed consent * at least one measurable lesion as determined by recist ver.1.1 * ecog ps score ≤ 1 * expected survival ≥ 12 weeks * for female or male patients of reproductive potential: agree to use contraception throughout the study and at least 6 months after the last dose. exclusion criteria: * subject who has received anti-cancer treatment within 4 weeks prior to the first dose of study treatment. * subject who has received radiotherapy or major surgery within 4 weeks prior to screening. * any toxicity due to prior therapy that has not resolved to ≤ grade 1 or returned to baseline by the time of starting study treatment. * subject with known severe (≥grade 3) hypersensitivity to any checkpoint inhibitor. * clinically significant laboratory abnormalities. * subject with a history of another invasive malignancy within 3 years before the first dose of study drug. * subject with active central nervous system (cns) metastases. * subject who requires high dose of steroids or other immunosuppressive medications. * subject with a history of autoimmune disease that has required systemic treatment in the past 2 years. * subject with active infection that requires systemic antimicrobial treatment. * subject with active hbv or hcv infection. * subject who has a known history of hiv infection. * subject with active tuberculosis. * subject with a documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with nyha class iv within 6 months prior to screening. * subject with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening ct scan. * subject who has received a prior allogeneic stem cell or solid organ transplant. * subject with a positive coronavirus disease (covid) test during screening. * subjects who have received a live attenuated vaccine within 30 days prior to screening. * subject with another underlying medical condition.

Keywords: immune checkpoint inhibitors antineoplastic agents therapeutic uses colorectal neoplasms head and neck neoplasms ovarian neoplasms urinary bladder neoplasms lung neoplasms antibodies, monoclonal anti-btn1a1 butyrophilins
computer aided detection of polyps during colonoscopy procedures

Conditions: Colo-rectal Cancer; Polyp of Colon; Adenomatous Polyps

Summary: the focus of the study is to evaluate impact on adenomas per colonoscopy (apc) with a computer aided detection (cad) software assisting the gastroenterologist during a colonoscopy procedure.

the details of the proposed study are as follows: 1. colonoscopy will be performed in the same standard of care manner as if no study was taking place. the video signal from the colonoscope will be fed into a computer running the endovigilant cad software in addition to the standard video output to the procedure monitor. the endovigilant cad software will display an annotated video on an additional monitor that includes both the colonoscopy picture and annotation by the software indicating the location of any polyps on the screen. 2. the endoscopist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the annotated video on the second monitor. 3. the endoscopist will primarily rely on the second monitor (augmented with annotation from endovigilant coloncad software) but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion, polypectomy etc.

Eligibility criteria:
inclusion criteria: * patient presenting for routine colonoscopy for screening and/or surveillance purposes * ability to provide written, informed consent and understand the responsibilities of study participation exclusion criteria: * patients with diminished cognitive capacity * patients with inflammatory bowel disease, ulcerative colitis or crohn's colitis * patients with incomplete colonoscopies (due to technical difficulties or poor bowel prep)
a study of hemay005 in adult with atopic dermatitis

Conditions: Hemay005, Atopic Dermatitis

Summary: a multicenter, randomized, double-blind, placebo-controlled, phase ii study to evaluate the efficacy and safety of hemay005 tablet in the treatment of moderate to severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: * understand and voluntarily sign the informed consent form for this study; * 18-75 years old (including boundary value) , gender is not limited; * ability to adhere to follow-up schedules and other program requirements; * according to hanifin \& rajka diagnostic criteria of atopic dermatitis (ad) , the patients with ad history ≥6 months; * at baseline, the severity of ad was moderate to severe: iga score was 3 or more, and the area of involved skin lesion was 10% bsa or more; * participants were required to use contraception during the study period. exclusion criteria: * a medical history unsuitable for participation in a clinical study； * pregnant or lactating women； * allergic to the drug or its preparation； * patients who had undergone major surgery within 6 months before screening or who were scheduled for major surgery during the trial period； * participants who had participated in any drug or device clinical trial within the previous 3 months were screened； * vaccination with live or attenuated vaccines is planned for the duration of the trial； * any drugs is taking that may affect the effectiveness evaluation; * any clinically significant abnormality in 12-lead ecg at screening that was judged by the investigator as unsuitable for inclusion； * when investgater believe that any condition could lead to unnecessary risks for patients participating in the study.
liposomal bupivacaine for pain control after rotator cuff repair

Conditions: Rotator Cuff Tear; Postoperative Pain

Summary: the use of an interscalene block (isb) is often associated with rebound pain that could be avoided through adjunctive therapy with longer duration. administration of a liposomal bupivacaine (lb) field block in addition to isb would overcome this rebound pain to provide greater pain relief and reduce opiate consumption when compared to isb alone. 50 patients were recruited and randomized into groups that either received or did not receive an intraoperative lb field block in addition to standard isb administration. visual analog scale (vas) pain scores and narcotic consumption were recorded over the five-day postoperative period to determine the effectiveness of lb pain relief.

arthroscopic rotator cuff repair (arcr) provides excellent clinical outcomes but is often associated with significant postoperative pain. as rotator cuff repair procedures become increasingly more common, these procedures and the narcotic prescriptions which accompany them may contribute to the rising opioid epidemic. the use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is a widely accepted approach for managing surgical pain and reducing opiate use. the purpose of this study was to determine whether using a field block of liposomal bupivacaine (lb) in addition to an interscalene block (isb) would provide greater pain relief and reduction in opiate consumption when compared to isb alone. the study enrolled 50 patients undergoing primary arcr surgery. patients were randomized to receiving intraoperative liposomal bupivacaine or not and provided with postoperative "pain journals" to document their daily pain on a visual analog scale (vas) and to track their daily opioid consumption during the first five post-operative days.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * undergoing an arthroscopic rotator cuff repair surgery of a full thickness tear * willing to fill out the "pain journal"; able to understand the informed consent process * willing to document informed consent prior to completion of any study-related procedure * able to read, comprehend, and complete subject-reported outcome measures in english exclusion criteria: * pregnant * documented history of drug or alcohol abuse * use of narcotic painkillers greater than 3 months prior to surgery * neurologic deficit or disability involving the surgical extremity * known allergy or intolerance to hydrocodone or oxycodone * known allergy to amide anesthetics * currently enrolled or planning to enroll in another clinical trial during this study that would affect the outcome of this study * history of cognitive or mental health status that interferes with study participation