Kornimate/medical-research-clean huggingface dataset:
a phase ii clinical trial of hydronidone capsules(f351) in patients with liver fibrosis induced by hbv chronic hepatitis

Conditions: Hepatitis B, Chronic

Summary: to explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis b.

primary observation indexes: hepatic fibrosis ishak score after treatment decreases by the proportion not less than 1 compared with that before treatment. secondary observation indexes : 1. negative conversion ratio of hbv dna after treatment (hbv dna\<1×103copies/ml) and falling range. 2. the falling proportion of fibrocan kpa value after treatment compared with that before treatment. 3. the falling proportion that decreases not less than 1 level and progression-free fibrosis after treatment compared with that before treatment. 4. the improvement of alt of liver function.

Eligibility criteria:
inclusion criteria: 1. aged 18-65, all genders. 2. history of chronic hepatitis b, hbsag positive≧six months. 3. alt\<eight-fold uln (maximum). 4. significant liver fibrosis confirmed by liver biopsy. 5. hbeag positive patients, hbv dna\>2.0×104 iu/ml (copies/ml); hbeag negative patients，hbv dna\>2.0×103 iu/ml (104copies/ml). 6. having not accepted the antiviral therapy with interferon and/or nucleoside analog. 7. having not taken anti-inflammatory drugs to protect liver within 1 month before selection. 8. capable of understanding and signing the informed consent before the study. exclusion criteria: 1. failing to meet any one requirement of the inclusion criteria. 2. having suffered massive hemorrhage of gastrointestinal tract within 3 months before selection 3. tbil\>three-fold uln. 4. afp\>100 ug/l 5. plt≦60×109/l 6. pta\<50% 7. having obvious space-occupying lesion in liver as shown by b ultrasound examination. 8. with a portal vein ≧1.2cm wide as shown by b ultrasound examination. 9. bmi index\>30. 10. the patient who suffered from liver function decompensation hepatic cirrhosis and liver neoplasms. 11. the patient with alcoholic, drug-induced, hereditary, immune and other viral and non- viral chronic hepatitis. 12. the patient with angiocarpy, lung, kidney, incretion, nerve and blood system disease and mental disease. 13. the patient with active peptic ulcer. 14. gestational and breast feeding women. 15. the subject is the legal disabled person according to the law of the people's republic of china on the protection of disabled persons of the april 2008 edition. 16. the subject who participated in other drug tests within recent 3 months. 17. the patient who is suspected with poor compliance or disagrees to participate in the test. 18. the patient who is considered by other investigators not to be suitable for participating in the study.
a prospective study comparing suture anchor and soft tissue pectoralis major tendon techniques for biceps tenodesis

Conditions: Bicep Tendinitis; Biceps; Tenosynovitis; Biceps Tendon Disorder

Summary: this is a prospective randomized controlled trial comparing two common techniques of long head of biceps tendon tenodesis in shoulder surgery. numerous techniques of biceps tenodesis currently exist and are commonly performed. we will be comparing the tenodesis procedure using a suture anchor device versus a technique where the tendon is simply sutured to the pectoralis major tendon.

biceps tenodesis is a commonly performed procedure in shoulder surgery. in many cases, it is performed in conjunction with a rotator cuff repair. currently, biceps tenodesis is performed in many different ways depending on surgeon preference. first, the location of the tenodesis can vary, as surgeons may prefer a suprapectoral or subpectoral tenodesis location. in addition, the tenodesis fixation technique can also vary, as surgeons have the option to use a screw or suture anchor to perform the tenodesis. there have been numerous studies comparing these various techniques, including suprapectoral versus subpectoral techniques and screw versus suture anchor techniques. none of these studies have been conclusive, and there continues to be controversy as to the best technique. the current study will compare two techniques of subpectoral biceps tenodesis. specifically, we will compare tenodesis using a suture anchor versus a technique where the tendon is simply sutured to the pectoralis major tendon. the latter technique has been previously described and published.

Eligibility criteria:
inclusion criteria: * age 18 - 100 years * able to provide written informed consent * has: (a) partial- or full-thickness rotator cuff tear verified by preoperative magnetic resonance imaging (mri) and arthroscopy; (b) concomitant biceps lesions (lhbt partial tear\>50%, slap type ii lesion, pulley lesion, or subluxation/dislocation of lhbt) that were diagnosed arthroscopically with concomitant symptoms; and (c) arthroscopic rotator cuff repair. exclusion criteria: * any medical illness that adversely impacts the patient's ability to complete the study procedures * isolated glenohumeral pathological conditions * any prior surgery on the same shoulder * complete rupture of the lhbt assessed by mri or at time of procedure * incomplete repair of the rotator cuff

Keywords: biceps tendinitis subpectoral biceps tenodesis biceps tendon disorder
investigation of oxidative markers and antioxidant defense in female patients with osteoarthritis

Conditions: Osteoarthritis

Summary: osteoarthritis has a multifactorial etiology: aging, genetic, sex, weight, alimentation, injuries, infections etc. the objective of the study is to investigate the eating behaviour of the patients included in the study by using a semiquantitative questionnaire (frequency and quantity) by estimating the foods that are known to be protective for osteoarthritis (vegetables, fruits, cereals) as the ones that are considered risk factors (meat origin, refined fats). also, the oxidative-antioxidative balance will be evaluated by determining markers: oxidated glutathione/reducted glutathione, catalase enzyme, superoxide dismutase, glutathion peroxidase and malonyldialdehyde.

a total of 300 patients with osteoarthritis will be included in the study. the objective of the study is to investigate the eating behaviour of the patients included in the study by using a semiquantitative questionnaire (frequency and quantity) by estimating the foods that are known to be protective for osteoarthritis (vegetables, fruits, cereals) as the ones that are considered risk factors (meat origin, refined fats). also, the weight and height of each patient will be assessed and the patients will be included in 4 classes based on the body mass index: underweight, normal weight, overweight and obese. the type of physical activity will also be noted and the oxidative-antioxidative balance will be evaluated by determining serum markers: oxidated glutathione/reducted glutathione, catalase enzyme, superoxide dismutase, glutathion peroxidase and malonyldialdehyde. correlation between eating behaviour, body mass index and oxidative stress markers will be made.

Eligibility criteria:
inclusion criteria: * osteoarthritis * signed informed consent exclusion criteria: * drugs or foods with antioxidant effects * lack of judgement * refuse to participate
a blinded, self-control trial to evaluate an artificial intelligence based cad system for diabetic retinography

Conditions: Diabetic Retinopathy

Summary: to evaluate the safety and performance of an innovative artificial intelligence based computer-aided diagnosis(cad) system for diabetic retinography, retinal images of patients with diabetes mellitus or diabetic retinopathy(dr) were collected retrospectively. all images were graded by a retinal specialists expert panel and the cad device using the international clinical diabetic retinopathy severity scale criteria. investigator responsible for dr grading by cad system is blinded to the dr grading results from the expert panel. finally, dr grading results of the cad system and experts were compared using sensitivity and specificity.

1. retinal images were collected retrospectively according to the following inclusion/exclusion criterion: inclusion criterion: clinical history of diabetes mellitus or diabetic retinopathy; fully gradable images; around 45° field which covers optic disc and macula; complete patient identification information; exclusion criterion: incomplete patient identification information; 2. dr grading by expert panel at first, retinal images are graded by three experts independently, then they met for a consensus meeting to discuss cases without initial agreement. if they can't achieve consensus, a final decision is made by the principal investigator. experts give a grading of both dr and diabetic macular edema (dme) for each image according to the international clinical diabetic retinopathy severity scale criteria and hard exudates around optic disc. 3. blinding and dr grading by cad system before dr grading by cad system, a randomized identification(id) is assigned to each retinal image, which ensures that investigator responsible for cad system operation is masked to the expert panel grading result. both dr and dme grading is generated by the cad system and the results are exported. 4. unblinding finally, all data are unblinded and results of the cad system are compared to the results of human grading, which is considered the gold standard, using measures as sensitivity and specificity;

Eligibility criteria:
inclusion criteria: * clinical history of diabetes mellitus or diabetic retinopathy; * fully gradable images; * around 45° field which covers optic disc and macula; * complete patient identification information; exclusion criteria: * incomplete patient identification information

Keywords: diabetic retinography, cad
the effect of primary care opioid taper plans on sustained opioid taper

Conditions: Opiate Replacement Therapy

Summary: the objective of this study is to examine the effects of opioid taper plans as documented in the electronic medical record for kaiser permanente washington (kpwa) patients. the study will compare different types of opioid tapering plans and will report on their effectiveness in producing sustained taper or discontinuation of long-term opioid therapy for chronic non-cancer pain while maintaining adequate pain control. the study population is kpwa patients receiving long-term opioid therapy from 2010 to 2017.

opioid taper is now encouraged by many health care organizations, but it is unclear if explicit plans for opioid taper by primary care providers are effective at promoting tapering or discontinuation, and if they are effective, which components account for their effectiveness. patients receiving long-term opioid therapy (ltot), who are candidates for tapering, often perceive a low risk of overdose and a high risk of increased pain with opioid tapering. they fear opioid withdrawal and lack of effectiveness of non-opioid therapies. for patients with opioid tapering experience, support from family and a trusted health care provider eased opioid tapering. many patients report improved quality of life following taper. little data exists on the optimal opioid taper strategy, including: use of long or short-acting opioids, frequency of clinic visits, use of adjunctive medications and the role of psychological support. recent initiatives to reduce high-dose opioid use at kaiser permanente washington offer an opportunity to study the effect of opioid taper plans and their components in an integrated care system with an electronic health record including all health encounters and pharmacy dispensing. this study will report the proportion of ltot patients who successfully taper compared to a similar group of ltot patients who don't achieve tapering or discontinuation of tapering. we will also evaluate whether taper plans, defined by the patient's primary care provider, increase the likelihood of successfully tapering comparing the two groups cited above.

Eligibility criteria:
inclusion criteria: * a cohort of patients enrolled in kaiser permanente washington who were receiving high dose, long-term opioid therapy (ltot) for treatment of chronic non-cancer pain during 2010-2017. high dose ltot defined above. * patients must be age \>18 years as of cohort entry and enrolled for at least 18 months during the study period. exclusion criteria: * patients under 18 years old * patients with any cancer diagnosis, hospice, nursing home care, methadone maintenance, buprenorphine for opioid use disorder, cognitive impairment, spinal cord stimulator, or intrathecal opioids.

Keywords: opioids chronic pain opioid therapy opioid taper
rheumatoid arthritis (ra) moderate to low disease activity study

Conditions: Rheumatoid Arthritis

Summary: to assess the clinical efficacy and safety of certolizumab pegol as add-on therapy with stable-dose disease-modifying antirheumatic drugs (dmards) for achieving clinical remission in patients with moderate to low disease activity rheumatoid arthritis

treatment period starts with a 24-week, double blind, placebo-controlled, randomized period followed by an open label phase until week 52. in the double blind phase eligible patients will be randomized via an interactive voice response system (ivrs) in a 1:1 ratio to receive either certolizumab pegol (400 mg at weeks 0, 2 and 4, followed by 200 mg every two weeks) or placebo up to and including week 22. all patients will continue to receive their disease modifying antirheumatic drugs (dmards) therapy established before study entry until week 52. at week 24, patients will not receive any injection but will be evaluated: * non-remitters at week 24 (patients who did not achieve remission at both week 20 and week 24) will be discontinued from the study and may be given the opportunity to enter in an open-label follow-up trial, c87080 \[nct00843778\], with certolizumab pegol. * remitters (i.e. patients who achieved remission as measured by clinical disease activity index (cdai) at both week 20 and week 24) will stop their randomized treatment (certolizumab pegol or placebo) and be followed up until week 52. remitters who flare up (cdai ≥11 confirmed at two consecutive visits four weeks apart) between week 24 and week 52 will be re-treated with the same dosing regimen of certolizumab pegol (3 administrations of 400mg, given every 2 weeks, followed by 200 mg given every other week) up to and including week 50. remitters who flare up between week 24 and week 52 and complete 52-week study period will be allowed to enter open label follow up trial at week 52.

Eligibility criteria:
inclusion criteria: * patients with established diagnosis of low to moderate adult rheumatoid arthritis, currently on disease modifying antirheumatic drugs (dmards) therapy for at least six months and not longer than 10 years exclusion criteria: * all the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment, or with the safety of the patient * previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial * patients must not have received any previous biological therapy for rheumatoid arthritis (ra)

Keywords: rheumatoid arthritis moderate to low disease activity certolizumab pegol
examining the role of the orexin system in sleep and stress in persons with opioid use disorder

Conditions: Sleep Disturbance; Opioid-use Disorder

Summary: this study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (mat) who are in early recovery from opioid use disorder (oud). briefly, the study will enroll recently abstinent oud patients (n=200) maintained on either extended-release naltrexone (xr-ntx), buprenorphine, or methadone. within each mat group, participants will be randomized to either suvorexant or placebo. the study is expected to have a 20% treatment attrition rate which will result in n=160 completers in the entire study. patients will be recruited from and treated at ashley addiction treatment, addiction treatment services at johns hopkins bayview medical center, man alive, or community providers.


Eligibility criteria:
inclusion criteria: * between the ages of 21-65, inclusive. * past 30-day sleep disturbance as evidenced by a pittsburgh sleep quality index total score \>5. * enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, or xr-ntx treatment for oud. * willingness to be maintained on a protocolized dose starting between 60-130mg methadone or 380mg xr-ntx for the duration of the study. * at least two weeks of continuous abstinence from illicit opioids as evidenced by self-report and urine drug screens collected as part of routine care. * willing to comply with the study protocol, which will include weekly study visits, daily actigraphy and ecological momentary assessments. * use of birth control throughout study. * have no clinically significant chronic medical disorders or conditions that are judged by the investigators to prevent participation. exclusion criteria: * serious mental illnesses that are unstable and could affect study participation (thought disorders, hallucinations, delusions, thoughts of harm to self/others). * current moderate to severe substance use disorder other than oud. * current illicit stimulant use, including cocaine and methamphetamine. * pregnant or breast feeding. * have a known allergy to the study medications. * past 30-day prescribed use of suvorexant. * current use of a benzodiazepine or other schedule iv medication for insomnia. * use of cytochrome p450 3a inhibitors. * current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medical history * apnea-hypopnea index \> 30. * use of glucocorticoid medications and any medication that would alter the hypothalamic-pituitary-adrenal axis. * past 30-day suicidal behavior as assessed by the columbia suicide severity rating scale (c-ssrs). * have circumstances that would interfere with study participation (e.g., impending jail; severe clinical issues).
quebec lung cancer screening plus trial

Conditions: COPD; Coronary Artery Calcification

Summary: does an educational intervention for untreated copd and cardiovascular disease which is integrated in an existing lung cancer screening program improve guideline concordant medication adherence at 12 months


Eligibility criteria:
inclusion criteria: * patient screened for lung cancer as part of the quebec lung cancer demonstration project by low dose ct scan of the chest. * cardiovascular aim: mild to severe cac identified on low dose ct, not on guideline recommended lipid-lowering therapy. * copd aim: diagnosed with copd, symptomatic (mmrc \>=1 or cat\>= 10) and untreated, or not on first line guideline recommended therapy for copd. exclusion criteria: * any participant with a high suspicion of lung cancer, defined as lung-rads (lung imaging reporting and data system) 3 or 4, as this is an inopportune time to initiate new medical therapies. * cardiovascular aim: absent cac, known clinical atherosclerosis, known former heart surgery, diabetes mellitus. * copd aim: asymptomatic, or already on appropriate first line copd therapy.

Keywords: copd coronary artery calcification lung cancer screening undiagnosed disease educational intervention medication adherence untreated disease statins inhalers
your coach next door study

Conditions: Childhood Obesity

Summary: your coach next door (ycnd) is a lifestyle intervention connecting children with overweight and their families with a coach close to home. this study goal is to examine the effects of ycnd for children and their families, (on their health, quality of life), and a process evaluation (process of the lifestyle intervention, and satisfaction for children, families and healthcare givers)

childhood overweight and obesity in an increasing problem worldwide. among other, childhood obesity is associated with type 2 diabetes, cardiovascular disease, nafld and decreased quality of life. in 2016 the lifestyle intervention your coach next door (ycnd) was founded in maastricht, the netherlands, as a tailored, network approach for children with overweight and obesity. ycnd is following the example of coach, the tailored lifestyleintervention for childhood obesity of the expertise centre of the mumc+ hospital. ycnd is connecting children with overweight and their families with a coach close to home. this study goal is to examine the effects of ycnd for children and their families, (on their health, quality of life), and a process evaluation (process of the lifestyle intervention, and satisfaction for children, families and healthcare givers)

Eligibility criteria:
inclusion criteria: * participant of the ycnd lifestyle intervention. * having overweight or obesity * younger than 18 years at inclusion exclusion criteria: * no exclusion criteria
eus-elastography and contrast-enhanced eus diagnostic accuracy in the differential diagnosis of subepithelial gastrointestinal tumors

Conditions: Gastrointestinal Subepithelial Tumors

Summary: the differentiation among the gastrointestinal subepithelial tumors (sets) represents a clinical challenge. endoscopic ultrasound (eus) alone may be ineffective in differentiating sets subtypes, and tissue sampling of these lesions may be technically difficult. eus elastography (eus-e) has been applied to many gastrointestinal diseases, providing a qualitative/semi-quantitative stiffness analysis, but only few studies have examined the role of eus-e in the diagnosis of sets. in addition, the use of contrast agents has improved the diagnostic performance of the eus, especially in the differentiation between gists and other gastrointestinal sets. the aim of the study is to examine the performance of eus-e and contrast enhanced-eus (ce-eus) in distinguishing among different gastrointestinal sets subtypes. eus patterns of different techniques will be compared to the final diagnosis gained by the analysis of histopatological specimens (surgical resection or eus-fnb) or imaging/clinical follow-up.


Eligibility criteria:
inclusion criteria: * patients with gi sets scheduled for eus-fnb * patients with age \> 18 but \<85 years exclusion criteria: * patients with gi sets \<15mm * severe coagulopathy defined as abnormal prothrombin time (pt) or partial thromboplastin time (ptt) that does not normalize after administration of fresh frozen plasma * severe cardiopulmonary diseases and severe chronic kidney disease defined as glomerular filtration rate (gfr) \< 15 ml/min * known allergic disposition to sonovue® * pregnancy
mobile phone technology to increase genetic counseling

Conditions: Ovarian Cancer

Summary: this innovative project seeks to harness mobile phone technology as a means to take preventive health care to a new level among ovarian cancer survivors. using the fogg behavioral model, developed from the concept of persuasive technology, this study proposes to develop the mobile application for genetic information on cancer (magic) intervention to motivate ovarian cancer survivors to undergo genetic counseling. the overall study objective is to develop and assess the feasibility and effectiveness of a theory-based intervention aimed to encourage ovarian cancer survivors to receive genetic counseling

this project seeks to harness mobile phone technology as a means to take preventive health care to a new level among ovarian cancer survivors. using the fogg behavioral model31 (fbm), developed from the concept of persuasive technology, this study proposes to develop the mobile application for genetic information on cancer (magic) week-long intervention to motivate ovarian cancer survivors to undergo genetic counseling.

Eligibility criteria:
inclusion criteria: * woman diagnosed with ovarian, primary peritoneal or fallopian tube cancer * 18 years old or older * at least a fifth grade education * able to read and write in english * voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. exclusion criteria: • known major psychiatric or neurological diagnosis