Kornimate/medical-research-clean huggingface dataset:
a real world study of ds-8201

Conditions: Breast Cancer Metastatic; Treatment Efficacy

Summary: a real world study of ds-8201


Eligibility criteria:
inclusion criteria: 1. male or female aged 18 or above; 2. the eastern cooperative oncology group (ecog) physical condition score of the united states is ≤2; 3. her2 positive (ihc 3+ or ihc 2+ and ish+) confirmed by tumor histology or cytology, and having received one or more anti-her2 drug treatments previously; or low expression of her2 confirmed by tumor histology or cytology (ihc 1+ or ihc 2+ and ish-), and having received at least one systemic treatment in the metastatic disease stage previously, or unresectable or metastatic breast cancer that relapsed during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy; 4. receive goldtrastuzumab treatment in the advanced stage; 5. during the study period, voluntarily abide by this trial protocol and receive regular follow-ups; 6. all women of childbearing age, fertile men or their spouses who have no plans for fertility or sperm donation throughout the trial period until 6 months after the last dose, or who voluntarily take effective contraceptive measures. exclusion criteria: 1. pregnant or lactating women; 2. those with acute or chronic infections, or those with other serious diseases at the same time, are judged by the researchers as unsuitable for this study; 3. having suffered from other malignant tumors within 5 years (excluding the following situations: cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma; a second primary cancer that has been completely cured and has no recurrence within five years; researchers have clearly identified which primary tumor source the metastatic foci belong to. 4. those with mental illness or mental disorders, poor compliance and inability to cooperate and describe treatment responses; 5. those with severe organic diseases or major organ failure, such as decompensated heart, lung, liver or kidney failure, which makes them unable to tolerate treatment; 6. patients allergic to trastuzumab; 7. patients who changed their treatment regimens after trastuzumab treatment due to reasons other than disease progression or intolerable adverse reactions; 8. the researcher believes that the patient has other circumstances that make them unsuitable for participating in this study
mcg for identification of myocardial ischemia in suspected nste-acs patients

Conditions: Non ST Segment Elevation Acute Coronary Syndrome

Summary: the goal of this multi-center observational study is to learn about the effectiveness of magnetocardiography in rapid and accurate identification of ischemia in patients with suspected nste-acs.

rapid and accurate identification of ischemia in patients with chest pain suspected of non-st-elevation-acute coronary syndrome (nste-acs) is of great clinical significance for timely and effective treatment. magnetocardiography based on spin-exchange relaxation-free (serf) principle can detect the weak magnetic field generated by the heart sensitively, which do not need ultra-low temperature cooling. magnetic signal does not decay through the skin and tissues as electricity does, hence magnetocardiogram (mcg) contains more information of diagnostic value of ischemia. the aim of this observational study is to optimize and validate mcg models as a fast and accurate strategy for detecting coronary ischemia, as a shortage of blood supply to myocardium, in patients who suffer from chest pain, and compare to routine diagnostic means.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older; 2. patients with symptoms of myocardial ischemia such as angina who are suspected to nste-acs and proposed to undergo cag or coronary cta; 3. signed informed consent. exclusion criteria: 1. patients with st-elevation myocardial infarction (stemi); 2. patients with non-ischemic dilated cardiomyopathy, or hypertrophic cardiomyopathy, or moderate or severe valvular disease; 3. patients with hemodynamic instability (systolic blood pressure\<90 mmhg, or who requires vasoactive drugs), or patients with tachyarrhythmia, ⅱ degree atrioventricular block and above that have not returned to normal; 4. patients who have severe renal abnormality with egfr \<30 ml/min, or patients who are on dialysis; 5. patients with malignant tumors with predicted survival of less than 1 year; 6. pregnant or breastfeeding women; 7. patients who are unable to enter the mcg device, who are unable to perform mcg examination due to interference from metal implants or other reasons, or who are deemed by the investigators to be unsuitable for enrollment.
intranasal oxytocin effects in alcohol withdrawal and dependence; follow-up study

Conditions: Alcoholism; Substance-Related Disorders

Summary: this study is an assessment of the long-term effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol after 60 days and 1 year. it is a follow-up study of a placebo-controlled randomized controlled study where subjects used oxytocin nasal spray during acute withdrawal and the following 4 weeks in an outpatient setting. half of the participants have received oxytocin nasal spray, the other half placebo nasal spray (nct02903251). (added march 2019: 24 patients were available for 1-year follow-up)


Eligibility criteria:
inclusion criteria: * participants in the rct (nct02903251) who completed the study exclusion criteria: * participants in the rct (nct02903251) who did not complete the study

Keywords: oxytocin administration, intranasal ethanol follow-up studies
feasibility study of peripheral venous cannulation pain in predicting acute pain after total knee arthroplasty

Conditions: Venous Cannulation Pain; Total Knee Arthroplasty; Movement-evoked Pain; Acute Pain

Summary: the goal of this prospective observational study is to explore the feasibility of preoperative peripheral venous cannulation pain score in predicting acute pain after total knee arthroplasty, including resting pain and movement-evoked pain.


Eligibility criteria:
inclusion criteria: 1. patients undergoing the first unilateral total knee arthroplasty surgery under general anesthesia combined with nerve block ; 2. age : 18 years old ≤ age ≤ 80 years old ; 3. asa grade i-ii ; 4. informed consent was signed by patients or immediate family members before operation. exclusion criteria: 1. there are known pain abnormalities, mental disorders, cognitive dysfunction ; 2. patients with long-term use of opioids and a history of drug dependence ; 3. patients with alcohol dependence ; 4. the patient refused to use the analgesic pump ; 5. difficult to understand the vas score ; 6. body mass index ≥ 40 ; 7. hand nerve abnormalities, hand loss ; 8. plan postoperative icu patients ; 9. in other cases, the researchers believe that is not suitable for this researcher.
an observational study of mircera (methoxy polyethylene glycol-epoetin beta) as maintenance treatment in patients with chronic renal anemia on haemodialysis

Conditions: Anemia, Kidney Disease, Chronic

Summary: this prospective observational study will evaluate the safety and efficacy of mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance esa treatment. data will be collected from patients receiving once monthly mircera according to standard of care and local labelling during 12 months of treatment.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * stage iv chronic kidney disease, on haemodialysis * chronic renal anemia, on maintenance esa treatment * hemoglobin concentration between 10.0 an 12 g/dl * continuous maintenance epoetin therapy with the same dosing interval during the previous month exclusion criteria: * contraindications to esa treatment (e.g. hypersensitivity, non-controlled hypertension) * hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) * anemia due to hemolysis, pure red cell aplasia
safety and efficacy of yhd001 in asthma

Conditions: Asthma

Summary: the main objective is to evaluate the safety/tolerability and efficacy of yhd001 compared to singulair or placebo in patients (n=96) with partially controlled asthma. the study will conduct with 4 comparative groups orally treated with yhd001 dose level 1(t.i.d.), yhd001 dose level 2(t.i.d.), singulair 10mg(q.d.) or placebo for 8 weeks.

singulair: montelukast sodium (leukotriene modulator)

Eligibility criteria:
inclusion criteria: * provision of signed written informed consent * acceptable medical history, physical exam,laboratory tests and ekg, during screening * nonsmoking (for longer than 1 year) patients with asthma * reversible airways obstruction (an increase in fev1 absolute value of 12% or greater) 20 to 30 minutes after inhalation of b-agonist * fev1 between 50% and 85% of the predicted value (withholding short-acting, inhaled b2-adrenergic agonist for 6 hours) exclusion criteria: * history of any clinically significant disease * history of drug/chemical/alcohol abuse * active upper respiratory tract infection within 3 weeks, emergency room treatment for asthma within 1 month, or hospitalization for asthma within 3 months of the prestudy visit
cyclosporine a in combination with nab-paclitaxel in patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this research study is to evaluate the safety of therapy with nab-paclitaxel and csa and if the addition of cyclosporine a (csa) to nab-paclitaxel helps stop cancer cells as well as or better than nab-paclitaxel alone.

treatment for metastatic breast cancer commonly involves the use of the chemotherapy drug nab-paclitaxel. nab-paclitaxel is a special preparation of paclitaxel inside a protein layer of albumin. other studies have shown cyclosporine a (csa) may block the progression of advanced breast cancer. the combination of nab-paclitaxel and csa is considered investigational which means it has not been approved by the us food and drug administration, fda. participants on this study will receive nab-paclitaxel through a vein in the arm weekly 3 weeks out of 4, in the outpatient clinic. on the same day as the first infusion of nab-paclitaxel, participants will begin taking csa tablets twice a day by mouth. participants will continue to receive study treatment as long as their tumor responds. if the tumor does not respond or the participant experience severe side effects from study treatment, she will be removed from the study and offered other therapies, if that is appropriate.

Eligibility criteria:
inclusion criteria * female or male patients with adenocarcinoma of the breast with metastatic disease. * patients may have evaluable or measurable disease. * age \> 18 years. * women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * able to swallow and retain oral medication. exclusion criteria * patients who have had any major surgery, hormonal therapy (other than replacement), chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier. prior nab-paclitaxel is allowed. * patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy. * patients with uncontrolled brain metastases or leptomeningeal disease or active neurologic impairment. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to cyclosporine a or nab-paclitaxel. * pregnant or lactating (cyclosporine a is excreted into breast milk) females * patients with gi tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for iv alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory gi disease (e.g., crohn's, ulcerative colitis). * hiv-positive patients are excluded since cyclosporine a may result in further immunosuppression

Keywords: breast cancer
application of impedance threshold device technologies to treat and prevent hypotension during dialysis

Conditions: Intradialytic Hypotension; End Stage Renal Disease; Low Blood Pressure

Summary: the purpose of this study is to evaluate the application of the impedance threshold device during hemodialysis in children to optimize fluid removal, reduce the incidence of complications (such as cramps,vomiting and hypotension), and device tolerance.

effective fluid removal during hemodialysis is one of the biggest challenges in children with end-stage renal disease (esrd). generally, children do not tolerate having more than 3-4% of their body weight removed during each dialysis session thus necessitating multiple sessions each week to ensure effective renal replacement. excessive fluid removal is often associated with nausea, vomiting, hypotension and cramps resulting in serious complications in patient care during and immediately after dialysis as well as reduced patient compliance. the development of novel therapies to increase the amount of fluid removed during each session without a corresponding increase in the incidence of complications is therefore very important to improve quality and compliance with hemodialysis; and eventually survival of children with esrd. the purpose of this study is to evaluate the application of the impedance threshold device during hemodialysis in children to optimize fluid removal, reduce the incidence of complications (such as cramps,vomiting and hypotension), and device tolerance.

Eligibility criteria:
inclusion criteria: * subjects 8-18 years of age * subjects undergoing hemodialysis for esrd exclusion criteria: * subjects less than 8 years old or greater than 18 years old. * hemodialysis for indications other than esrd. * current symptoms of chest pain, shortness of breath, fever, presence of dilated cardiomyopathy, unstable congestive heart failure, pulmonary hypertension, atrial fibrillation, hyperthyroidism, and aortic stenosis.

Keywords: hypotension during dialysis end stage renal disease decrease complications during dialysis low blood pressure
changes in body composition under ustekinumab in psa

Conditions: Psoriatic Arthritis

Summary: there is not much body composition and bone mineral density data available for patients with psoriatic arthritis (rheumatoid arthritis) compared to control subjects. the evaluation of the total fat mass and in particular of its abdominal distribution (visceral adiposity) is important because an excessive adiposity generates adverse effects on the health (hypertension, dyslipidemia, cardiovascular risk and resistance to the insulin). in addition, data on changes in body composition and bone mineral density were not available under a new psa treatment, namely ustekinumab (anti-il12 / 23 antibody). it is proposed to conduct a pilot study to evaluate body composition, distribution (visceral adiposity) and bone mineral density in patients with psoriatic arthritis (versus control subjects) and their changes after 6 months of treatment with ustekinumab


Eligibility criteria:
inclusion criteria: * psoriatic arthritis: 1. men and women ≥ 18 years 2. patients with psa according to caspar criteria, 3. patients who do not have yet started ustekinumab, 4. patients who signed the informed consent. * healthy volunteers: 1. men and women ≥ 18 years 2. patients who signed the informed consent. exclusion criteria: * items 1 to 10 are applicable to healthy volunteers and psa 1. history of fragility fracture and / or t-score ≤-3 if ≥50 years and / or z-score ≤-3 if \<50 years during the screening phase, 2. corticosteroids ≥10 mg / day, 3. diseases or treatments affecting bone metabolism (breast cancer with anti-aromatase, malabsorption, primary hyperparathyroidism, uncontrolled hyperthyroidism ...), 4. history of radiotherapy on the lumbar spine or hip, 5. patients undergoing hormone replacement therapy (hrt) or patients already on anti-osteoporotic therapy (bisphosphonates, strontium ranelate, teriparatide or denosumab), 6. chronic kidney disease with creatinine clearance (ckd-epi) ≤ 30 ml / min, 7. weight\> 160 kg, 8. patients under restrictive diet or considering a diet of this type during the study period, 9. patients who have an intense exercise program or plan to benefit from it during the study period, 10. pregnant or lactating women or having a pregnancy project,

Keywords: psoriatic arthritis ustekinumab body composition bone mineral density adiposity
efficacy and safety of ad-mscs plus calpocitriol ointment and psori-cm01 granule in psoriasis patients

Conditions: Mesenchymal Stromal Cells; Psoriasis; Drug Effect; Drug Toxicity

Summary: the purpose of this study is to evaluate the efficacy and safety of adipose derived mesenchymal stem cells (ad-mscs) plus calpocitriol ointment and psori-cm01 granule with moderate to severe psoriasis. any adverse events related to ad-mscs infusion will be monitored.the primary outcome is the reduction rate of pasi(psoriasis area and severity index) and treatment response will be computed from pasi before and after treatment.

the purpose of this study is to evaluate the efficacy and safety of adipose derived mesenchymal stem cells (ad-mscs) plus calpocitriol ointment and psori-cm01 granule with moderate to severe psoriasis. any adverse events related to ad-mscs infusion will be monitored.the primary outcome is the reduction rate of pasi(psoriasis area and severity index) and treatment response will be computed from pasi before and after treatment.

Eligibility criteria:
inclusion criteria: 1. moderate to severe psoriasis vulgaris ( pasi \> 10 or bsa \>10%) 2. 18 to 65 years old 3. written/signed informed consent exclusion criteria: 1. guttate psoriasis, inverse psoriasis or exclusively associated with the face 2. acute progressive psoriasis, and erythroderma tendency 3. current (or within 1 year) pregnancy or lactation 4. current significant anxiety or depression with the self-rating anxiety scale (sas) \> 50 or the self-rating depression scale (sds) \> 53, or with other psychiatric disorders 5. with history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments. those who with malignant diseases, infections, electrolyte imbalance, acid-base disturbance. patients with clinical test results listed below: abnormal serum calcium level ( ca2+ \> 2.9 mmol/l or \< 2 mmol/l);ast or alt 2 times more than normal upper limit; creatinine and cystatin c more than normal upper limit; hemoglobin elevates 20g/l more than normal upper limit,or hemoglobin reduction to anemia; platelet count less than 75.0\*10\^9/l; white blood cell less than 3.0\*10\^9/l; or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study 6. patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction 7. allergy to anything else ever before; 8. current registration in other clinical trials or participation within a month; 9. topical treatments (i.e. corticosteroids or retinoic acid or vitamin d analogs ) within 2 weeks; systemic therapy or phototherapy (ultraviolet radiation b,uvb) and psoralen combined with ultraviolet a (puva) within 4 weeks; biological therapy within 12 weeks; 10. medical conditions assessed by investigators, that are not suitable for this clinical study.
what is the impact of early life exposures on the cardiovascular system in young adulthood?

Conditions: Preterm Birth

Summary: the purpose of this study is to investigate whether early life exposures such as premature birth or exposure to preeclampsia before you are born results in long-term alterations in the cardiovascular system that increase risk of cardiovascular disease development.

while the incidence of cardiovascular disease has reduced dramatically, coinciding with favourable changes in risk factors, cardiovascular disease remains the single largest cause of mortality and premature mortality in the united kingdom. identification of novel biological pathways that underlie disease susceptibility raises the potential for new early primary prevention strategies to complement classical management. there is particular interest in the role of early environment in 'programming' risk of cardiovascular disease in later life and growing evidence that various early life exposures impact cardiovascular health in the longer term. we have thus designed the early vascular study to investigate the long-term impact of early life exposures, with a particular focus on the impact of preterm birth, in the presence or absence of pregnancy-induced hypertension in the mother, on the cardiovascular system in young adulthood. this study also allows investigation of the long term impact of perinatal interventions used in this cohort. comprehensive multi-modality non-invasive imaging measures of cardiovascular structure and function allow precise quantification of cardiovascular phenotype. this is combined with blood sample collection to study changes in molecular and metabolic markers and pathways.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * preterm-born cohort: born premature (\<37 weeks completed gestation), originally recruited as part of a randomised feeding trial at birth from one of five united kingdom centres between 1982 and 1985. * term-born cohort: born at term (\>37 weeks completed gestation) with normal birth weight for gestational age. * able (in the investigator's opinion) and willing to comply with all study requirements. exclusion criteria: -the participant may not enter the study if any of the following apply: * unwilling or unable to give informed consent for participation in the study. * any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study. * contraindication to cardiovascular magnetic resonance imaging.
the role of acupuncture-induced exosome in treating post-stroke dementia

Conditions: Exosome; Post-stroke Dementia; Acupuncture

Summary: stroke is the main cause of disability and the second main cause of dementia. approximately 21.5% of patients develop dementia within 4 years after stroke. the main clinical manifestation of dementia is memory and cognitive impairment. at present, acetylcholinesterase inhibitors and nmda glutamate receptor antagonists, were used for dementia treatment, but those drugs have limited efficacy. exosome is an extracellular vesicle from the endosomal, size range from \~40 to 160 nm (average \~100 nm). it contains many cells including dna, rna, fat, and metabolites, as well as cytoplasm and cell surface proteins that play a role in regulating intercellular communication. some studies believe that exosomes in the circulation are an ideal marker to reflect the pathological progress and recovery of stroke, and play a key role in the reorganization of tissues and the progress of neurodegeneration after stroke. our previous studies have known that acupuncture can increase the long-term potentiation of hippocampal ca1 in rats with ischemic stroke, and improve learning-memory and neurological function. therefore, the purpose of this study is to explore the role of acupuncture-induced exosome in the treatment of post-stroke dementia.


Eligibility criteria:
inclusion criteria: 1. history of stroke. 2. mmse score between 16 and 26. exclusion criteria: 1. those with serious diseases, such as heart failure, chronic failure or cancer patients, etc. 2. intolerance to acupuncture treatment. 3. allergy to acupuncture needles. 4. refusal to sign the informed consent form.