Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of domestic tenofovir tablets in chinese patients with chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to evaluate the safety and efficacy of domestic tenofovir disoproxil fumarate tablets in chinese patients with hepatitis b ,compared with tenofovir disoproxil fumarate tablets of gilead.


Eligibility criteria:
inclusion criteria: * the initial treatment of subjects diagnosed of hbeag positive or negative chronic hepatitis b * aged 18 to 65 years old，male or female * patients with previously hbsag-positive lasted for 6months at least：hbeag-positive subjects, hbv-dna\> 105copies/ml； hbeag-negative subjects, hbv-dna\> 104copies/ml. * 2 times the upper normal limit (2 × uln) ≤ alanine aminotransferase (alt) ≤ 10 × uln. * total serum bilirubin (tbil) ≤ 2.5 × uln. * prothrombin activity (pta) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds). * wbc ≥ 3.5 × 109 / l, plt ≥ 80 × 109 / l, serum albumin (alb)≥ 35 g / l. * creatinine (cr) ≤ 1× uln，serum phosphate was normal. * patients signed an informed consent form and compliance was good. exclusion criteria: * patients were infected with other viruses as hav, hcv, hev, hiv etc. * patients with cirrhosis or liver cancer. * pregnant woman, lactating women . * patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases. * patients with metabolic or autoimmune diseases such as systemic lupus erythematosus. * patients allergic for study drug.
effectiveness of controlled-perturbation gait training on gait rehabilitation and fear of falling in individuals with gait impairments

Conditions: Cerebrovascular Disorders; Peripheral Nervous System Diseases; Musculoskeletal Diseases; Joint Diseases

Summary: gait dysfunction often occurs following stroke, neurological or musculoskeletal disease, injury and surgery. one of the consequences of such deficit is an increased risk of fall and injury. a gait training regime that incorporates controlled perturbation has been found to reduce falls in elderly population but the effectiveness of such training has yet to be studied. the aim of this study is to evaluate the effectiveness of specific controlled dynamic perturbation training, during gait, on gait rehabilitation, fear of falling and falling with gait impaired individuals. perturbation will be performed using a specifically designed system that provides small, controlled and unpredictable perturbations during treadmill walking.

a total of 100 adults with gait dysfunction will be enrolled, evaluated and trained. they will be randomly assigned to two groups: perturbation training group and balance exercises group. both groups will receive standard physiotherapy treatments. no gender based differences are expected so we will be able to pool male and female individuals for this analysis. each subject of the experimental and of the control groups will be trained on 12 occasions over a period of 10-12 weeks (15 minutes, 2-3 times/week) in addition to standard care physiotherapy. gait, balance function and fear of falling will be tested in both groups before, immediately after, 3 and 6 months after completion of the training period to explore the benefit of training.

Eligibility criteria:
inclusion criteria: * ambulatory capability of over 2 in functional ambulation classification . * no less then 4 weeks following surgery. * preserved mental capacity. exclusion criteria: * less then 4 weeks following surgery or injury. * symptomatic orthostatic hypotension, respiratory or cardiovascular, disorders that may interfere with participation in the perturbation program.

Keywords: balance control aging balance reactions perturbation
a trial of genotype-based warfarin initiation in patients with mechanical prosthetic heart valve

Conditions: Anticoagulation Treatment Overdose; Heart Valve Diseases

Summary: until very recently, warfarin is still the best drug of choice for long-term anticoagulation for patients with mechanical prosthetic heart valve. however, the complication of warfarin account for 75 percent of the whole complication after the mechanical prosthetic heart valve replacement. interindividual variation in warfarin dose is mediated by multiple factors.advanced models using combinations of clinical attributes and genetic factors(cyp2c9, vkorc1, and cyp4f2) explain 50-75% of variability in warfarin dose requirements.these warfarin dosing models have the potential to improve patient safety by reducing or eliminating serious adverse events. the investigators conducted a prospective, randomized, blinded, two arm trial to test this hypothesis.


Eligibility criteria:
inclusion criteria: * the first time to receive elective mitral and/or aortic mechanical prosthetic valve replacement * willing to join in the clinical trial and comply with the protocol. exclusion criteria: * other ethnic groups than han * previously receive any other cardiac surgery * emergent surgery * simultaneously carry out other cardiac surgeries,such as cabg * age younger than 18y or older than 65 year * drug abuser and wine abuser * any malignancy * moderate or severe hepatic or kidney insufficiency * any thyroid disease * the history of warfarin or vitk consumption 2 week before the surgery * any hematological disease or history of bleeding * combination with any drugs that significantly influence warfarin other than cordarone * pregnancy * any contraindication of warfarin * infectious endocarditis * advanced valvular disease * pathological obesity * psychological disease * any patient having joined in other clinical trial in the previous 30d * basic inr \> 1.4

Keywords: anticoagulation bleeding cyp2c9 cyp4f2 vkorc1 warfarin dosing heart valve diseases pharmacogenomics
a clinical trial with a self-controlled, multicenter, pediatric eeg intelligent analysis system to assist in diagnosis

Conditions: Pediatric Epilepsy

Summary: a diagnostic accuracy study on artificial intelligence eeg analysis system assisted doctors to diagnose pediatric epilepsy.


Eligibility criteria:
inclusion criteria: * age \< 18 years old * children with suspected epilepsy exclusion criteria: * during eeg monitoring, the patients had other serious neurological diseases and mental diseases concurrently * used medication that affect eeg data within 3 weeks, such as sedatives and anti-epileptic medications * substandard data quality, such as data lack of key records, electrode connection discontinuity, insufficient recording time, or the presence of serious artifacts * incomplete or missing data * equipment or operational abnormalities, data for which eeg monitoring has not been performed continuously
a study ly2228820 for recurrent ovarian cancer

Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Summary: a study for women with ovarian cancer that has returned at least 6 months after platinum-based chemotherapy.

phase 1b is unblinded and will have a small number of participants that will take ly2228820 plus gemcitabine and carboplatin to test the safety of the combination and determine a recommended dose for the phase 2 portion. phase 2 will be blinded and all study participants will receive carboplatin and gemcitabine. participants of one group will receive ly2228820, and the other group will receive placebo. if the participant achieves at least stable disease, there is a maintenance phase following the first 6 cycles. the participant will take either ly2228820 or placebo. the participant will continue therapy until disease progression or other discontinuation criteria are fulfilled.

Eligibility criteria:
inclusion criteria: * have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer * have been treated one time with a platinum-based chemotherapy and your disease has come back at least six months after you completed treatment * are able to swallow tablets * have given written informed consent prior to any study procedures * have adequate blood counts, hepatic and renal function * have performance status equal to or less than 2 on eastern cooperative oncology group (ecog) scale * have negative pregnancy test, and if participant is of child bearing potential must use birth control while on study and for three months after stopping study drug exclusion criteria: * have been previously treated with gemcitabine for ovarian, fallopian tube or primary peritoneal cancer * are currently enrolled or discontinued less than 14 days from another clinical trial * have a history of inflammatory bowel disease (crohn's disease or ulcerative colitis) * have taken certain medications or had grapefruit juice within 7 days of initial dose of study drug, as levels of the study drug may be affected. * must not be pregnant or breastfeeding. * have malignancy or metastasis of the central nervous system * have borderline malignancy
home blood pressure study for recent stroke survivors with high blood pressure *on hold due to global pandemic*

Conditions: Ischemic Stroke; Hypertension

Summary: the purpose of this pilot study is to assess the feasibility of implementing a home blood pressure self-management program in a population of recent stroke survivors in the washington, d.c. area. the investigators hypothesize that hypertensive stroke survivors in the washington, dc area who participate in the home blood pressure monitoring program will have a greater reduction in mean systolic blood pressure (sbp) from baseline to 3 months, as measured by automated office blood pressure (aobp), as compared to usual care.

the purpose of this trial is to determine if a home blood pressure self-management (hbps) program, including home monitoring and medication adjustments, is practical to use in recent stroke survivors and whether or not it is associated with lowering blood pressure after 3 months. data from this trial may be used to do more research and may be used by doctors when seeing patients.this research is being done because high blood pressure, also called hypertension, is the leading risk factor for stroke. lowering blood pressure (bp) has been shown to lower the risk of future strokes. the majority of stroke survivors continue to have uncontrolled bp. currently, blood pressure (bp) is most often measured in the doctor's office. however, those single bp measurements are not the best picture of blood pressure over time and can be influenced by the stress of being in a doctor's office, known as the "white coat effect". this is why measuring bp at home may paint a more accurate picture of a patient's true long-term bp. home blood pressure monitoring (hbpm) is recommended in the recently updated national hypertension guidelines. home bp monitoring plus guided bp medication self-adjustments is associated with lower bp in patients with high blood pressure. the investigators believe that a hbps program, including medication self-adjustment and home monitoring, may help to reduce blood pressure in patients with hypertension within 3 months.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke in the past 180 days of screening * age \>/= 18 years old * automated office blood pressure ≥135 systolic or ≥85 diastolic at time of screening * stage 2 hypertension (as defined by \>140 mmhg sbp and or \>90 mmhg dbp on 2 occasions or history of hypertension prior to stroke or currently taking antihypertensive medications) * able to live independently (as defined by modified rankin scale score of 0-2) exclusion criteria: * ckd stage iv or greater (gfr \< 30) * inability to check bp in either arm (e.g. amputation, lymphedema) * pregnancy * high-grade intracranial or extracranial stenosis requiring a higher bp goal * unable to provide informed consent for themselves in english or spanish * life expectancy less than 12 months

Keywords: blood pressure stroke hypertension blood pressure monitor home blood pressure monitor ischemic stroke stroke prevention
feasibility and safety of fasting in fertility treatment

Conditions: Sub Fertility, Female; Fertility Disorders; Cycle Disorders Menstrual; Ovulation Disorder; Ovulation Absent; Ovulation Delayed; Ovulation; Failure or Lack of; Sub-fertility

Summary: this exploratory study investigates fasting as a potential supportive therapy in infertility treatment for women suffering from infertility

this 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in infertility. the participants will be randomized in two groups: fasting and waiting list. all groups will be trained and accompanied by medical experts and dieticians. in addition, qualitative interviews will be conducted including individual and focus group interviews with a subgroup of participants.

Eligibility criteria:
inclusion criteria: * women aged 25 to 45 years * unfulfilled desire to have children \>1 year * declaration of consent * 20 kg/m² ≤ bmi ≤ 40 kg/m² exclusion criteria: * language barriers * previously known serious mental illness or cognitive impairment * patients with anatomical/organic damage and proven uterine abnormalities * eating disorders in the medical history * serious previous internal diseases * lack of internet access * no consent to randomisation * participation in other studies

Keywords: fasting natural therapies caloric restriction lifestyle modification dietary restriction dietary intervention prolonged fasting weight loss complementary medicine integrative medicine
benefit of assistive listening device for lateralization

Conditions: Hearing Loss, Sensorineural

Summary: speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a phonak roger microphone and hearing aid with compatible phonak roger receiver. target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. participants will repeat back words and percent correct is calculated.


Eligibility criteria:
inclusion criteria: * experienced hearing aid users, age 18 or older * bilateral, symmetric moderate to moderate-severe sensorineural hearing loss * good understanding of the english language * health outer ear as confirmed by otoscopy * informed consent as documented by signature exclusion criteria: * contraindications to the medical device noted upon otoscopy * known hypersensitivity or allergies to materials of the investigations device or comparator * inability to produce reliable test results * known psychological problems * self reported symptoms of vertigo or dizziness
sofosbuvir and ribavirin in patients with chronic hcv with cirrhosis and portal hypertension with or without liver decompensation

Conditions: Hepatitis C; Cirrhosis; Portal Hypertension; With or Without Liver Decompensation

Summary: this study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (sof) plus ribavirin (rbv) for 48 weeks in adults with compensated and decompensated chronic hepatitis c virus (hcv) infection. approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.


Eligibility criteria:
inclusion criteria: * chronic infection with hepatitis c with hcv rna \> 1000 iu/ml * individuals with cirrhosis with child-pugh score \< 10 * esophageal or gastric varices on endoscopy within 6 months prior to or at screening * hepatic venous pressure gradient (hvpg) \> 6 mmhg * body mass index (bmi) ≥ 18 kg/m\^2 * naïve to all nucleotides/nucleoside treatments for chronic hcv infection exclusion criteria: * have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance * hiv or chronic hepatitis b virus (hbv) infection (hbsag positive) * alpha-fetoprotein (afp) \> 50 unless negative imaging for hepatic masses within the last 6 months or during screening * refractory ascites as defined by requiring paracentesis \> twice within 1 month prior to screening * active variceal bleeding within 6 months of screening * expected survival of \< 1 year * history of hepatorenal, or hepatopulmonary syndrome. * evidence of renal impairment (crcl \< 50 ml/min) * history of major organ transplantation, including liver transplant.
comprehensive geriatric assessment for perioperative optimization in cystectomy

Conditions: Bladder Cancer

Summary: patients with muscle-invasive bladder cancer are often older and multimorbid, thus in an increased risk of perioperative mortality and morbidity in relation to radical cystectomy (rc). the aim of the study is to investigate the effect of perioperative comprehensive geriatric assessment (cga) and tailored intervention in older, frail patients with bladder cancer undergoing rc.

patients will be randomized 1:1 and allocated into either control or intervention study arm. the control group will receive perioperative "care as usual" according to exciting principles and guidelines. the intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment, focused on optimizing health issues of expected importance in further course of surgery. furthermore, postoperative ward rounds by a geriatric team will be conducted. thus, the course of treatment for each patient will be a close interdisciplinary collaboration.

Eligibility criteria:
inclusion criteria: 1. patients with muscle-invasive bladder cancer and scheduled radical cystectomy. 2. planned urinary diversion with an ileal conduit 3. age ≥ 65 years. 4. patients considered frail by g8 screening tool (total score ≤14). exclusion criteria: 1. patients who refuse or are not able to provide informed consent. 2. patients who do not speak or understand danish. 3. planned concomitant nephroureterectomy or other major surgical intervention at the same time as rc

Keywords: frailty comprehensive geriatric assessment
a study on β-elemene as maintain treatment for newly diagnosed malignant gliomas

Conditions: Anaplastic Oligoastrocytoma; Anaplastic Astrocytoma; Glioblastoma

Summary: this study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma.

this study is being conducted to help determine whether β-elemene as maintain treatment for complete remission patients of newly diagnosed malignant gliomas following standard treatment, is able to delay tumor growth, or impact how long people with newly diagnosed high-grade glioma. β-elemene will be given 600mg/d,d1-14,q28 days for 6 cycles.

Eligibility criteria:
inclusion criteria: * - page 3 of 4 \[draft\] - arms assigned interventions * temodar experimental: temozolomide +α-ifn four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-ifn α-ifn： 3miu (3million) day1,3,5 of each 28 day tmz：150 mg/m\^2 daily on days 2-6 of each 28 day study cycle and 200 mg/m\^2 daily of subsequent cycles drug: temozolomide dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days other names: • temodar drug: α-ifn 3miu (3million) d1，3，5 other names: minimum age: 18 years maximum age: 75 years gender: both accepts healthy volunteers?: no criteria: inclusion criteria: * age: 18 years to 75 years * complete remission patients of newly diagnosed who iii-iv glioma following standard treatment * karnofsky performance score ≥ 60 * adequate bone marrow, liver and renal function * ability of subject to understand character and individual consequences of the clinical trial * written informed consent * anticipating survival ≥2 months exclusion criteria: * refusal to participate the study * known hypersensitivity or contraindication to temozolomide * incompletely radiation * pregnant or lactating females * malignant tumor other than brain tumor * contraindicated for mri examination * unable to comply with the follow-up studies of this trial * purulent and chronic infected wounds * uncontrolled psychotic disorders or epilepsy * progression disease

Keywords: high-grade glioma chemotherapy β-elemene
paclitaxel-trastuzumab in egfr-mutated nsclc patients

Conditions: NSCLC; HER2-expression; EGFR-mutation

Summary: this study is a pilot study in egfr-mutated nsclc patients who have progressed on standard-dose tkis. tumor biopsies will be evaluated for her2-expression. in case of her2 expression, patients can participate in the trial after obtaining informed consent. patients will be treated with weekly paclitaxel-trastuzumab.


Eligibility criteria:
inclusion criteria: * histologically confirmed stage iv non-squamous nsclc patients. * patients must have been detected with an activating egfr mutation at baseline and must have yet progressed on erlotinib, gefitinib or afatinib monotherapy in daily dose of 150 mg, 250 mg or 40 mg respectively. (patients with unknown mutation status that have exhibited a response to these agents or stable disease for at least 6 months while on treatment with gefitinib or erlotinib are also eligible). * rebiopsy after having acquired resistance to tki-treatment must have been performed and her2-overexpression (positive immunohistochemistry staining) must have been detected. * there must be at least one measurable disease site, according to recist 1.1 criteria. * who performance status 0-2. * willing and able to comply with the study prescriptions. * 18 years or older. * not pregnant or breast feeding and willing to take adequate contraceptive measures during the study. * ability to give written informed consent before patient registration. exclusion criteria: * no uncontrolled infectious disease. * no other active malignancy. * no major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or vats biopsy) in the previous 4 weeks. * no treatment with investigational drugs. * no known hypersensitivity to trastuzumab-paclitaxel * no symptomatic brain metastases. * history of coronary artery disease, nyha class iii or iv and left ventricular ejection fraction (lvef) of \<45%.

Keywords: nsclc her2-expression egfr-mutation trastuzumab paclitaxel