Kornimate/medical-research-clean huggingface dataset:
pyrotinib combined with brain radiotherapy in breast cancer patients with brain metastases

Conditions: Breast Cancer; Brain Metastases; HER2-positive Breast Cancer

Summary: brain metastases occur in 30-50% of patients with metastatic her2-positive breast cancer. pyrotinib is an irreversible pan-erbb receptor tyrosine kinase inhibitor (tki) with activity against epidermal growth factor receptor (egfr)/her1, her2, and her4. this study consists of two parts. in a phase ib part, investigators will explore the safety and tolerance of pyrotinib plus capecitabine combined with brain radiotherapy. after completing the phase ib part, investigators will review the data and decide whether this patient is included in before the start of a phase ii part. in the phase ii part, investigators will evaluate the efficacy of pyrotinib plus capecitabine combined with brain radiotherapy in patients with her2 positive breast cancer patients with brain metastases.


Eligibility criteria:
inclusion criteria: 1. pathologically confirmed her2 positive advanced breast cancer 2. age\>18 years. brain metastases confirmed by enhanced brain mri 3. kps≥70 4. life expectancy of more than 12 weeks 5. prior therapy of oral dexamethasone not exceeding 16mg/d 6. time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1. 7. maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain mri(2-3mm) 8. prior endocrine therapy were allowed 9. anti-her2 targeted treatment were allowed 10. screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration): 1. absolute neutrophil count (anc) ≥ 1.5 x 109/l, platelets≥ 90 x 109/l, hemoglobin ≥ 90 g/l 2. aspartate aminotransferase/alanine aminotransferase (ast/alt) ≤2.5 x uln without liver metastasis,≤ 5 x uln with liver metastases 3. serum bun and creatinine ≤ 1.5 x upper limit of normal (uln) 4. lvef ≥ 50% 5. qtcf \< 480 ms 6. inr≤1.5×uln，aptt≤1.5×uln 11. signed the informed consent form prior to patient entry exclusion criteria: 1. leptomeningeal or hemorrhagic metastases 2. uncontrolled epilepsy 3. severe complication: cardiovascular disease, end-stage renal disease, severe hepatic disease, infection etc. 4. pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures. 5. inability to complete enhanced mri 6. patients who are difficult or unable to be followed-up 7. not suitable for inclusion for specific reasons judged by sponsor 8. patients unable to swallow, with chronic diarrhea, intestinal obstruction, or multiple factors that affect drug use and absorption 9. history of allergy to pyrotinib or capetabine 10. history of immunodeficiency, including hiv positive, active hbv/hcv or other acquired, congenital immunodeficiency disease, or organ transplantation history 11. previous use of pyrotinib combined with capetabine

Keywords: pyrotinib brain radiotherapy
a trial of levator muscle blocks following posterior colporrhaphy surgery to reduce post-operative pain.

Conditions: Post Operative Pain

Summary: to determine if levator muscle block with bupivacaine improves postoperative pain control relative to placebo controls among women undergoing prolapse surgery involving a posterior colporrhaphy. improvement is defined as no less than a 25% lower total pain score on a ten point numerical pain scale.


Eligibility criteria:
inclusion criteria: * any woman over the age of 18 years with a capacity to give informed consent who are undergoing vaginal prolapse surgery including a posterior colporrhaphy may be included in the study. exclusion criteria: * any woman who is a non-english speaker, does not have ability to provide consent, has a cardiac arrhythmia, liver disease, myasthenia gravis, bleeding diathesis or adverse reaction / allergy to anesthetic will be excluded. women that are also having vaginal mesh excisions at the time of prolapse repair or those that will undergo subsequent surgery in the follow up period will be excluded.
effect of medical marijuana on neurocognition and escalation of use

Conditions: Pain; Insomnia; Depression; Anxiety

Summary: this study will use a randomized controlled design to test whether patients who use medical marijuana, compared to a waitlist control group, experience a change in health outcomes (relief of symptoms, or adverse health outcomes such as new-onset symptoms of cannabis use disorders, neurocognitive impairments) or brain-based changes.

this trial is a randomized, longitudinal study of medical marijuana (mm) that will: (1) characterize the impact of mm on indices of addiction, such as cud, escalation of use, tolerance, and withdrawal among those who stop using, (2) assess, via dosing diaries, the effect of mm use patterns on use of other medications, and perception of underlying disease symptomatology, (3) characterize the impact of mm on neurocognitive performance, including executive function, memory, attention, and decision-making and (4) examine evidence for impact of mm on brain structure and function. this study will enroll 200 adults with no prior history of cud or heavy marijuana use, who express interest in using mm to treat pain, insomnia, anxiety, and/or depression. participants will be randomly assigned to either an active mm arm (n = 100), or to a waitlist control arm (wlc) (n = 100). participants will be assessed at baseline, regularly for 3 months, and at a 6-month and 12-month follow-up for mm use behaviors, development of cud, perception of disease symptomatology, and neurocognitive performance. urine collected at each visit will be assessed with quantitative assays. mri scans will be collected to longitudinally investigate possible brain changes associated with mm use.

Eligibility criteria:
inclusion criteria: 1. men and women aged 18-65 years, inclusive; 2. competent and willing to provide written informed consent; 3. desire to use medical marijuana for self-reported pain, sleep, or affective (mood and/or anxiety including ptsd) symptoms. 4. not in possession of a medical marijuana card, but expressing intent to get one. 5. able to communicate in english language. exclusion criteria: 1. current daily marijuana use (prior to enrollment) 2. current substance use disorders (e.g. cocaine, opiate, stimulant). light to moderate alcohol use is permitted (defined as 16 or less on the audit), and nicotine dependence is permitted because of the high co-use of nicotine and marijuana. participants cannot meet current scid criteria for a use disorder on any illicit substance other than nicotine. 3. pregnant (verified by a urine test). 4. in the opinion of the investigator, not able to safely participate in this study because of any medical or psychological issues (e.g. psychosis) that might compromise their safety.

Keywords: medical marijuana cannabis pain insomnia depression anxiety addiction dependence neurocognition mri
diagnostic and therapeutic applications in microarrays in organ transplantation

Conditions: Validation Study of Molecular Diagnostic System; Development of Reporting System for Molecular Diagnosis; Incorporate Molecular Diagnosis Into Diagnostic Standards

Summary: the current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the banff classification which represents arbitrary international consensus. recent data-driven approaches using molecular and conventional technologies indicate that mere consensus produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. to address this unmet need and improve diagnostics in the area of organ transplantation, the alberta transplant applied genomics centre (atagc) has developed a new diagnostic system that combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first integrated diagnostic system. the present study will validate and refine this system in 500 prospectively unselected biopsies for clinical indications from american, canadian and european centres in addition to 300 biopsies already collected. due to a considerable interest and support from participating centers, the study is further extended to 1500 prospective biopsies. thus this is the extension of the intercom study (intercomex). in addition to demonstrating the feasibility and value of this system in routine patient care and clinical trials, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback on how this system can best improve patient care.

the study has enrolled so far 3012 biopsies from 2313 participants and the results are analyzed for these biopsies. follow-up data is, and will be collected.

Eligibility criteria:
inclusion criteria: * all kidney transplant recipients ≥18yrs of age undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enrol in the study. exclusion criteria: * patients will be excluded from the study if they decline participation or are unable to give informed consent.

Keywords: global gene expression molecular diagnostic classifiers
photophoresis versus ciclosporine in severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: severe atopic dermatitis (ad) is a recurrent and debilitating disease often requiring systemic immunosuppressive treatment. the efficacy of cyclosporine a (csa) is well proven but potential side effects are concerning. several reports point at extracorporeal photopheresis (ecp) as an efficient alternative treatment modality with few and mild side effects. however, no direct comparison between csa and ecp in the treatment of ad has been performed so far. in this trial we test the hypothesis that ecp is non-inferior to standard treatment with csa.


Eligibility criteria:
inclusion criteria: criteria of inclusion were refractoriness to standard topical treatment (corticosteroid ointments, uva, uvb, puva, tar). exclusion criteria: criteria of exclusion were pregnancy, uncontrolled hypertension, previous malignancy, infectious disease, liver/kidney disease or active treatment with ecp or immunosuppressants within 4 weeks prior to start of trial.

Keywords: atopic dermatitis ciclosporine extracorporal photopheresis
non-pharmaceutical motion sickness mitigation

Conditions: Healthy

Summary: the purpose of this study is evaluate the effect of timing and magnitude on the administration of our nonpharmaceutical treatment to motion sickness, and to evaluate the effect of galvanic vestibular stimulation (gvr) amplitude on functional fitness task performance.


Eligibility criteria:
inclusion criteria: * must be able to consent to participate themselves. * must be able to attend in-person sessions at the mayo aerospace medicine and vestibular research laboratory in scottsdale, az. * no racial ethnic groups will be excluded. * must be fluent speakers of english. exclusion criteria: * history of vestibular disease, migraine, or significant balance disorder. * traumatic brain injury. * recent middle ear infection or recent motion sickness (within 72 hours). * history of severe motion sensitivity. * women who are pregnant.
the effect of adding sufentanyl to bupivacaine in transversus abdominis plane block to reduce the narcotic dosage and pain after cesarean delivery

Conditions: Pain

Summary: adding sufentanyl to bupivacain in transversus abdominis plane (tap) block under ultrasound guide can reduce narcotic dosage, side effects and pain after cesarean delivery.


Eligibility criteria:
inclusion criteria: * female 18 to 40 years * class asa 1 and 2 * candidates for elective cesarean section exclusion criteria: * renal failure * liver failure * cardiac disorder * coagulopathy * hepatomegaly * splenomegaly * drug sensitivity and abuse * morbid obesity * smoking * history of post operative nausea and vomiting * motion sickness * local hypoesthesia

Keywords: cesarean delivery tap block sufentanyl narcotic dosages
xian-hua-cha for relieving hyperlipidemia with obesity

Conditions: Hyperlipidemias; Obesity; Body Fat Disorder

Summary: in the past decades, lipid and body fat disorders become a serious global healthcare issue, especially among the obese population. the aim of this study is to include 100 selected patients with bmi higher than 27 and hyperlipidemia, and a crossover design is used to explore the efficacy of "xian-hua-cha (xhc)" on relieving hyperlipidemia among obese patient. for this purpose, the changes of patients' body weight, body fat and the metabolic parameter including blood sugar, cholesterol, triglyceride are analyzed in the end of this study.

recently, there are more and more studies show the natural herbal products can improve obesity and related metabolic disorders through changing the body composition and even body weight, but most of the studies are still at the phase of animal studies. in the ancient chinese medical book danxi's mastery of medicine mentioned "overweight people often have phlegm." from the past observational study, obesity is related phlegm, and the recent concept shows that obesity is a chronic inflammation disease. therefore, we combined phlegm removal herbal medicine and chinese medicine for clearing heat and detoxifying together for obese patients with lipid disorders in clinical practice. the aim of this study is to include 100 selected patients with bmi higher than 27 and hyperlipidemia, and a crossover design is used to analyze the efficacy of "xian-hua-cha (xhc)" on relieving hyperlipidemia among the obese population. for this reason, the changes of patients' body weight, body fat and the metabolic parameter including blood sugar, cholesterol, triglyceride are collected for analysis. besides, we also record adverse effects from taking xhc to assess the safety of xhc.

Eligibility criteria:
inclusion criteria: 1. bmi ≧ 27kg/m2 2. total cholesterol \> 200 mg/dl or ldl \> 130 mg/dl or triglyceride \> 150 mg/dl 3. age ≧ 20 years and \< 75 years 4. no recognition difficulties 5. willing to sign inform consent and comply to protocol exclusion criteria: 1. pregnant or breast-feeding women 2. endocrine disorders (uncontrolled hypo/hyperthyroidism, adrenal gland disorder) 3. diagnosis of neurologic or psychiatric diseases 4. liver or renal dysfunction (ast/alt higher than 3 times of upper normal limits; egfr \< 60 ml/min/1.73 m2) 5. acute stress condition (severe infection, receive major surgery in the recent 1 month) 6. vision, or hearing impairment 7. with other clinical trial medication 8. with medication for obesity or hyperlipidemia in the recent 1 month 9. heavy smoker, alcoholism or substance abuse 10. severe organ dysfunction: malignancies, autoimmune diseases

Keywords: chinese herbal medicine xian-hua-cha hyperlipidemia obesity body fat
effects of exenatide on postprandial hyperlipidemia and inflammation

Conditions: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance

Summary: the primary goal of this study is to determine the acute effects of exenatide on postprandial hypertriglyceridemia. secondary goals are to determine whether there are additional improvements in postprandial lipids and lipoproteins and whether (by the reduction of hyperglycemia alone or in combination with declines in hyperlipidemia) exenatide reduces the pro-inflammatory potential of the postprandial period.


Eligibility criteria:
inclusion criteria: * recently diagnosed type 2 diabetes (within 3 years) on diet or igt * fasting triglyceride levels \>140 and \< 400 mg/dl and values varying less than 35% between two screening measurements * normal liver function tests and white blood cell count exclusion criteria: * type 2 diabetes for \> 3 years or hba1c ≥ 7.5 * known or suspected type 1 diabetes * any diabetes medications in the past 3 weeks, tzd in the prior 3 months or prior regular use of insulin * creatinine \> 2.0 mg/dl or other evidence of active kidney disease * hepatic enzyme elevation \> 2x normal * known nonalcoholic fatty liver disease * malabsorption of fat or other nutrients, severe lactose intolerance or other significant gastrointestinal or pancreatic problems * recent history of nausea or vomiting * acute bacterial or viral illness or evidence of other active infection in the past 4 weeks * a prior cardiovascular event, stable or unstable angina or other major illness in the past 6 months * current regular use of anti-inflammatory medications or antioxidants, including over the counter medications and high dose salicylates (\>1 g/day) * any lipid lowering therapy in the prior 3 weeks other than a statin medication. subjects receiving a statin medication must be on a stable dose for at least 2 months prior to participation.
autologous platelet gel in wound healing of coronary artery bypass grafting (cabg) patients

Conditions: Wounds; Infection

Summary: this study will determine if autologous platelet gel (apg) on sternal incision and conduit sites will improve wound healing and decrease infection in coronary artery bypass grafting surgery patients.

the purpose of this study is to determine if the use of autologous platelet gel (apg) on sternal incision and conduit sites will improve wound healing and decrease the incidence of infection in patients undergoing coronary artery bypass grafting surgery

Eligibility criteria:
inclusion criteria: * any patient who meets criteria and consents to undergo a cabg procedure involving conduit sites and consents to this study. exclusion criteria: * any patient, after inclusion, whom is later determined to have had on-going therapy that could influence wound healing such as radiation or chemotherapy, extensive steroid use, or accidental trauma such as burns, etc.

Keywords: surgical site healing treated with autologous platlet gel
evaluation of the impact of a personal and domestic hygiene intervention on lead exposure in a community close to a mine dump

Conditions: Lead Poisoning; Lead Poison Children

Summary: the study evaluates the impact of a personal and domestic hygiene intervention on exposure to lead in a community close to a mine dump. a before and after intervention study will be conducted in a selected area to determine lead exposure levels and the reduction or not after application of the intervention.

a before and after intervention study will be conducted with a control and intervention group, where data will be collected at the household (through questionnaire based interviews, floor and/or windowsill samples and soil samples collection) and individual level (through hand dust wipe sample collection). in phase one, both the control and intervention group will be interviewed, household floor and/or windowsill dust wipes will be taken, yard soil sample collected and hand dust wipe samples will be taken from children in participating households. after baseline data collection, participants will be allocated into either intervention or control group. the intervention group will participate in the domestic hygiene demonstration and educational discussion.

Eligibility criteria:
inclusion criteria: * children between the ages of one and five years exclusion criteria: * children above 5 years

Keywords: lead lead exposure mine dumps
nutrition effects on fatigue during tennis playing

Conditions: Fatigue

Summary: the main objective of this study is to investigate the effects of ingestion of different sports drinks (nutrattente / nutraperf / nutrarecup) on fatigue induced by a tennis tournament simulation.


Eligibility criteria:
inclusion criteria: * about 18 to 35 years (inclusive) subject has a stable weight for at least three months before the start of the study * subject able and willing to comply with the protocol and agreeing to give their consent in writing * subject affiliated with a social security scheme * subject willing to be included in the national register of volunteers who lend themselves to biomedical research

Keywords: fatigue tennis nutrition tournament simulation delivery of health care
dual-diagnosis and compulsory treatment

Conditions: Substance-Related Disorders; Dual Diagnosis

Summary: the norwegian social and welfare act of 1992, opened for compulsory commitment of patients with serious alcohol and drug problems to inpatient care. clinical research of compulsory committed dual diagnosed patients is to date unavailable and is demanded by the health authorities of norway. because there has been limited examination/screening and no post-treatment research efforts on this group of patients, the investigators have limited knowledge of the treatment as well as the patient group. do compulsory treated patients differ from those voluntarily admitted? does this type of treatment influence the patients' motivation to change their behaviour, and does the treatment effort lead to positive outcome effects in the long run? the primary aim is to acquire new and in depth descriptive knowledge about the compulsory treated group of patients according to: drug dependence, psychiatric and somatic co-morbidity and socio-demographic characteristics, and investigate whether the treatment yields the intended outcomes in terms of improved substance abuse measures. a second aim is to compare the group with a corresponding group of voluntarily admitted patients within the same wards. a follow-up interview focusing on motivational issues within 6 months post treatment to evaluate the long-term results of the treatment is planned. a quasi-experimental, prospective case-control study will be conducted. compulsory committed patients in five counties during a two year period, will be compared to a group of voluntarily admitted patients. the groups will be compared regarding 1) description and screening 2) motivation to change and 3) outcome results after 6 months. both official authorities as well as clinical practitioners would benefit from valid norwegian results and knowledge within this field to form further policies and evidence based best practice for this vulnerable group of patients.


Eligibility criteria:
inclusion criteria: * patients with alcohol and substance use disorders * estimated premorbid iq of 70 or higher exclusion criteria: * active drug or alcohol abuse

Keywords: coercion
contrast-enhanced ultrasound vs conventional us-guided percutaneous needle biopsy for pancreatic diseases: prospective multicenter randomized controlled trial

Conditions: Pancreatic Disease

Summary: according to previous studies, contrast-enhanced ultrasound (ceus) -guided core biopsy(gb) could improve the diagnosis of biopsy in liver and other superficial mass compared to conventional us-gb. the purpose of this randomized trial is to estimate whether ceus-gb achieve excellent diagnostic value to conventional us-gb in percutaneous biopsy for pancreatic diseases.

the patients with pancreatic diseases who need receive percutaneous biopsy were randomized with 1:1 ratio into undergo ceus-gb group and conventional us-gb group.the aims include: comparison the diagnostic accuracy rate between ceus and us group. comparison the diagnostic specificity, sensitivity and complication rate between ceus and us group.

Eligibility criteria:
inclusion criteria: * age ≥18 years, who/ecog scores \<2; * radiographic examination reveal focal pancreatic lesions; * no history of local treatment for pancreatic lesions, systemic chemotherapy, targeting, immunotherapy, etc; * normal organ function, including the following criteria: 1. routine blood test: hb≥80 g/l; plt≥50×109/l; 2. coagulation function test: pt\<20s. exclusion criteria: * the lesions could not be shown by ultrasound and contrast-enhanced ultrasound; * allergic to ultrasound contrast agent; * cardiovascular and cerebrovascular diseases, liver, kidney and lung failure with significant clinical symptoms; * history of unexplained bleeding, severe anemia, bleeding tendency or uncorrected coagulopathy; * combined with active infection; * massive ascites; * patients or family members do not agree to enter the study; * pregnant or lactating women; * the investigator considers that there are any other factors that may be inappropriate for inclusion or affect the subject's participation in the study.