Kornimate/medical-research-clean huggingface dataset:
development and research of an individualized intelligent platform for rehabilitaion in parkinson's disease

Conditions: Parkinson Disease

Summary: the present study aims to compare the clinical efficacy of intelligent power therapy, intelligent lsvt-big therapy, and the three exercise models currently in clinical use. dcm_ir analysis will also be incorporated into the analysis to develop a personalized and intelligent parkinson's rehabilitative therapy platform.

background: parkinson's disease is a progressively degenerative disorder. patients need early screening, therapeutic intervention, and personalized interaction with outpatient rehabilitative treatment. in the past, it had been difficult to meet these goals. recent advances in bio-sensors technology has enabled collection of bio-metric data. models of brainwave analysis have also matured. in addition, our ability to analyze vibrational spectrogram had also greatly improved. how to combine these enabling technologies to meet the needs of parkinson's patients is an urgent topic of research. objective: the present study aims to compare the clinical efficacy of intelligent power therapy, intelligent lsvt-big therapy, and the three exercise models currently in clinical use. dcm_ir analysis will also be incorporated into the analysis to develop a personalized and intelligent parkinson's rehabilitative therapy platform. method: patients will be randomly assigned into three groups, i.e. intelligent power, intelligent lsvt-big, and current protocol group. single blind data collection will be used. patients will be evaluated immediately before treatment, immediately after treatment, and 4 weeks after treatment. evaluated criteria will include mini-bestest, unified parkinson's disease rating scale, muscle power of lower extremity, time up and go, walk velocity, step length, cadence, and parkinson's disease questionnaire pdq-39. expected outcome: an intelligent rehabilitative therapy platform may be built on the sensor data and neural-network analysis of the data. the platform will enable patients to interact with medical personnel on out-patient basis. if further combined with dcm_ir analysis, personalized therapeutic efficacy indicator may be uncovered, thereby, realizing intelligent personalized rehabilitative therapy.

Eligibility criteria:
inclusion criteria: 1. .parkinson's disease diagnosis, hoehn-yahr level i-iii 2. .stable medicine intake for 2 weeks at least 3. .able to walk independently for 15 meters 4. .aged 40-85 years old exclusion criteria: 1. .cognition deficits(mmse score\<24) 2. .combined other neurological disease, such as stork, sci, and so on. 3. .pregnant or breastfeeding

Keywords: parkinson disease intelligent rehabilitaion
efficiency and satisfaction with telephone consultation in neuro-urology: experience of the covid-19 pandemic

Conditions: Efficacy, Self; Satisfaction, Patient; Telemedicine

Summary: the covid-19 pandemic has necessitated drastic measures in order to limit the spread of sars-cov-2. the stay home policies for the whole population and especially for frail patients and the express instruction to deprogram non-urgent consultations and interventions limited the clinic visits in neuro-urology department. in this context, telemedicine was seen as a pragmatic solution to provide follow-up care for our neurologic patients. due to the delay in deploying telemedicine and the cognitive impairment of some of our patients, telephone consultation has been prioritized. the covid-19 pandemic might be an opportunity to review and refine our practices in neuro-urology. for the follow-up of selected patients, telephone consultations may be efficient and cost effective. the aim of the study is to assess the efficiency and the satisfaction with telephone consultation for the physician and the patient. the study was conducted in a neuro-urology department of a university hospital in france. during the stay-home policies for the covid-19 pandemic, all the scheduled medical visits were converted into telephone consultation. new patients weren't included. for each teleconsultation, the physician assess the duration of the consultation, the number of tries to join the patient, the efficiency of the consultation, the difficulty to obtain relevant information due to the phone way of the consultation and the lack of physical examination. on the next days, the patient was contacted by phone and was asked a) if he was satisfied of being phoned by the physician, b) if the teleconsultation was embarrassing, c) if he had enough time of teleconsultation d) if he got all the answers to his queries, e) if he would preferred to had a physical consultation f) to assessed the global satisfaction of the teleconsultation and g) if in the future, they may considered converting some clinic visits to teleconsultations. the physician and the patient assessed whether this teleconsultation has replaced a physical visit. the usual transport mode of the patient for a clinic visit and the need to take a day off for worker patients were recorded. the primary aim was to assess the efficiency and the satisfaction of the telephone consultation. the primary outcome was the evaluation of the efficiency of the telephone consultation by the physician on a numerical 10-points scale. the secondary outcome was the evaluation of the satisfaction of the telephone consultation by the patient on a numerical 10-points scale. four hundred teleconsultations are scheduled for five physicians.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * telephone consultation exclusion criteria: * new patient in the department

Keywords: telemedicine neurourology efficacy satisfaction
safety, effectiveness and quality of life of trastuzumab deruxtecan in patients with her2+ breast cancer

Conditions: HER2-positive Breast Cancer

Summary: collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable her2-positive breast cancer.

the present observational study aims to collect data on long-term safety of trastuzumab deruxtecan, with a primary endpoint on trastuzumab deruxtecan related adverse drug reactions (adrs) of interest. data on patient profile, treatment history (before, during and after trastuzumab deruxtecan administration), effectiveness and health-related quality of life will also be collected in a real-life setting, to confirm and complement data from clinical trials. patients will be recruited whether they have started trastuzumab deruxtecan treatment or will start it at the time of inclusion, whether they were prescribed compassionate trastuzumab deruxtecan or marketed enhertu®, in order to rapidly collect a large set of data.

Eligibility criteria:
inclusion criteria: * male or female adult patient (age ≥ 18 years); * unresectable or metastatic her2+ breast cancer, previously treated with at least 2 lines of anti-her2, and: * previously treated by compassionate trastuzumab deruxtecan (atu group), or * previously treated or planned to be treated by trastuzumab deruxtecan (enhertu®), upon the investigator's decision (post-marketing authorization group); * patient who expresses non-opposition to participate in the study, or deceased patient who did not express his/her opposition to the use of his/her personal data while alive. exclusion criteria: - previous participation in an interventional clinical trial with trastuzumab deruxtecan
the safety, tolerability, and pharmacokinetics study of hec113995

Conditions: Major Depressive Disorder

Summary: multiple dose safety, tolerability, pk and food effect study of hec113995 pa•h2o in healthy subjects


Eligibility criteria:
inclusion criteria: * 1. subjects who are willing and are able to provide a written informed consent to participate in the study. * 2. without plan for pregnancy or pregnant within 3 months after enrollment throughout the trial. * 3. subjects aged between 18 and 45 (both inclusive) years old. * 4. healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening. * 5. subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, chest x-ray and 12-lead electrocardiogram (ecg). exclusion criteria: * 1. subjects with a positive serology for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), hepatitis c virus (hcv) antibodies and/or tp antibodies at screening. * 2. subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;subjects with history of epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma. * 3. known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique. * 4. use of any prescription or non-prescription medications within 14 days prior to initial dosing,or use of any medications known to inhibit or induce cytochrome p enzyme drug metabolism within 28 days prior to initial dosing. * 5. consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. * 6. positive results from urine drug screen test. * 7. history of alcoholism or drink regularly within 3 months prior to the study(defined as alcohol consumption of \> 21 units/week), or positive results from alcohol breath test. * 8. regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug. * 9. donate blood or lose blood 400 ml or more within 1 month prior to initial dosing. * 10. subjects who plan to receive or have had organ transplants. * 11. females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential. * 12. subjects who participated in another clinical trial within 3 months prior to initial dosing. * 13. any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
the effect of compound herbal formula (rhd-1) on hbv carrier with abnormal liver function

Conditions: Liver Dysfunction

Summary: the aim of the study is to examine whether the compound herbal formula (rhd-1) is effective on hbv carrier with abnormal liver function.

% change hbv dna title and liver function.

Eligibility criteria:
inclusion criteria: * 40 \< gpt \<200 hbv carrier age: 18-65 yrs old exclusion: creatinine \>2.0 mg/dl total bilirubin \> 2.0mg/dl not suitable patients diagnosis by physician in charge.

Keywords: hbv carrier hbv dna title chinese medicine liver function rhd-1
efficacy of actos lipitor pegasys & ribavirin in chc gt 1 patients who relapsed or nonresponded to peg/riba

Conditions: Hepatitis c

Summary: the aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a lipid lowering agent (statin) improves sustained virologic response rates in patients who have previously not responded or relapsed on standard pegylated interferon and ribavirin therapy.

the study will evaluate the use of atorvastatin and pioglitazone in the pre-treatment of insulin resistance and lipid levels prior to the addition of pegylated interferon and ribavirin for chronic hepatitis c (chc). if improvement is seen in insulin resistance patients may then be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin. this study could demonstrate the value of pretreating and continuing treatment for insulin resistance with pioglitazone in chc, genotype 1 patients who have previously not responded or relapsed to prior pegylated interferon and ribavirin treatment. changes in lipids are not a primary or secondary endpoint in this study.

Eligibility criteria:
inclusion criteria: * gt 1 previously treated with pegylated interferon \& ribavirin \& either non-responded or relapsed after cessation of therapy * insulin resistance * compensated liver disease * wbc \< 3,000/ mm3 * neutrophil count \< 1,500/mm3 * platelets \< 65,000/ mm3 * albumin \> 3 gm/dl exclusion criteria: * participants on metformin or other thiazolidinedione must have 3month wash-out period * women who are pregnant or breast-feeding * males with pregnant partners * co-infection with hav, hbv, or hiv * ophthalmic abnormalities such as severe retinopathy * poorly controlled thyroid dysfunction * serum creatinine concentration \> 1.5 times uln * severe psychiatric or neuropsychiatric disorders * history of alcoholism or drug addiction 1 year prior to screening * seizure disorders not controlled with medication * significant cardiovascular dysfunction within the past 12 months * chronic pulmonary disease

Keywords: gt1 hcv non responder relapser
effects of pulmonary rehabilitation on skeletal muscle in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: in a former study, the investigator observed significant differences in the response to pulmonary rehabilitation between copd patients with the "normal" genetic variant of alpha-1 antitrypsin (pimm) and those with a homozygous deficient variant (pizz) (jarosch et al., 2016, doi: 10.1159/000449509). pizz copd patients showed less improvement in exercise capacity compared to pimm patients. this latter finding was mirrored by an increase of oxidative myofiber type i proportion - that is important for aerobic exercises in daily life - in pimm but not pizz patients. based on this finding of impaired skeletal muscle adaptation, the aim of this study is to compare the effects of pulmonary rehabilitation including exercise training on a) specific enzymes of energy metabolism reflecting the oxidative capacity of the skeletal muscle and b) the analogue gene expression of these oxidative enzymes in a cohort of pimm and pizz copd patients.


Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease * phenotype pimm or pizz * written informed consent exclusion criteria: * any comorbidities that prevent patients from participating in an exercise training program * necessity of anticoagulant therapy * other genetic variants of alpha-1 antitrypsin than pimm or pizz

Keywords: alpha-1 antitrypsin deficiency pulmonary rehabilitation exercise training skeletal muscle biopsy
personalized pacing: a new paradigm for patients with diastolic dysfunction or heart failure with preserved ejection fraction

Conditions: Pacemaker; Diastolic Dysfunction; Diastolic Heart Failure

Summary: recent exploratory studies suggest that pacemaker patients with diastolic dysfunction (dd) or heart failure with preserved ejection fraction (hfpef) may benefit from a higher backup heart rate (hr) setting than the factory setting of 60 beats per minute (bpm). in this prospective double-blinded randomized controlled study, pacemaker patients with dd or overt hfpef and either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing will be enrolled and randomized to either a personalized lower hr setting (mypace group, based on a height-based hr algorithm) or to the standard 60bpm backup setting (control group) for 1 year.


Eligibility criteria:
inclusion criteria: * implanted pacemaker with either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing or 3) rv pacing \<2% and paced qrs duration \<150ms * clinical evidence of heart failure with preserved ejection fraction or diastolic dysfunction, based on: * dyspnea with exertion * or nyha class ≥ ii heart failure * or pulmonary edema on prior chest imaging or documented on exam * or is taking loop diuretics for heart failure * or had ntprobnp \>400 ng/ml in the last 24 months * or a heart failure hospitalization in the last 2 years * or has diastolic dysfunction on echo * or has left ventricular hypertrophy on echo * or has left atrial (la) dilation (la volume/bsa index \>28ml/m2) exclusion criteria: * left ventricular ejection fraction \< 50% * life expectancy \< 12 months * symptomatic pulmonary disease on home oxygen * uncontrolled hypertension as defined by blood pressure \>160/100 mmhg on two checks ≥15 minutes apart * hypertrophic cardiomyopathy * more than moderate valvular disease * aortic valve replacement \< 1 year * angina pectoris * creatinine \> 2 * hemoglobin \< 8 g/dl * participation in another clinical trial or registry study * inability to follow up for regularly scheduled pacemaker appointments or to follow up for this study * pregnant patients or patients of childbearing age without reliable contraceptive agent (intra-uterine device, birth control implant, compliance with contraception injections or contraception pills) for the duration of study participation

Keywords: heart failure with preserved ejection fraction diastolic dysfunction resting heart rate personalized lower rate setting
study of aro-enac in healthy volunteers and in patients with cystic fibrosis

Conditions: Cystic Fibrosis, Pulmonary

Summary: the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (pk) of single doses of aro-enac in healthy adult volunteers; and to evaluate the safety, tolerability, pk and efficacy of multiple doses of aro-enac in patients with pulmonary cystic fibrosis.


Eligibility criteria:
inclusion criteria: * women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception * willing to provide written informed consent and to comply with study requirements * normal electrocardiogram (ecg) at screening * non-smoking * normal pulmonary function tests at screening (nhvs only) * no abnormal finding of clinical relevance at screening other than cf for cf patients * confirmed diagnosis of cf based on source verifiable medical record (cf patients only) * all other treatments for cf have been stable for at least 2 months and patient is willing to continue this treatment regimen without change for duration of study (cf patients only) exclusion criteria: * acute lower respiratory infection within 30 days of screening (nhvs only) * history of asthma (specifically, those subjects at risk of bronchial hyperactivity), anaphylaxis or airway hyper-reactivity * clinically significant history of hyperkalemia or presence of hyperkalemia at screening * clinically significant health concerns (other than cf in cf patients) * human immunodeficiency virus (hiv) infection, seropositive for hepatitis b virus (hbv), seropositive for hepatitis c virus (hcv) * uncontrolled hypertension * excessive use of alcohol within one month prior to screening * use of illicit drugs within 1 year prior to screening * use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study * cf exacerbation within 30 days of dosing (cf patients) * history of solid organ transplant (cf patients) * diagnosis of hepatic cirrhosis (cf patients) note: additional inclusion/exclusion criteria may apply per protocol
berberine effect on cytokine, crp, metabolic disturbance as an adjunctive therapy in schizophrenia patients

Conditions: Schizophrenia

Summary: the etiology and pathogenesis of schizophrenia remains unclear. immune dysfunction hypothesis for schizophrenia has attracted increasing attention of the researchers, substantial evidences suggested the levels of c-reaction protein and cytokine such as il-1β, il-6, tnf-α markedly elevated in patients with schizophrenia which may be particularly relevant for the cognitive impairment and metabolic disturbance of schizophrenia. in recent years, it has been demonstrated the beneficial effects of berberine on regulating lipid and glucose metabolism, reducing the proinflammatory status and improving cognition. as the investigators known, the report of berberine being used in schizophrenia is rare. this protocol is aim to evaluate berberine, as an adjunctive therapy, on inflammatory markers, lipid and glucose metabolism, cognition in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * individuals who age 18 to 60 years diagnose schizophrenia according the structured clinical interview for dsm-iv axis i disorders (scid). * the patients have illness for less than 5 years and have stable dose of the current antipsychotic drug for at least one month. * well established compliance with inpatient treatment per treating clinician's judgment. on baseline, at least 60 for positive and negative syndrome scale (panss) total score. * able to complete the cognitive assessment battery female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study. exclusion criteria: * individuals who refuse to provide informed consent. * currently substance abuse or psychiatrically unstable per treating clinician's judgment. * one with significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases also not suitable for this trial. * currently on anti-inflammatory or immunosuppressant medication including oral steroids and history of chronic infection (including tuberculosis, hiv and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition pregnancy or breastfeeding.

Keywords: berberine cytokine crp metabolism schizophrenia
a study to optimize subretinal surgical delivery and to evaluate safety and activity of opregen in participants with geographic atrophy secondary to age-related macular degeneration (galette)

Conditions: Geographic Atrophy

Summary: this study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of opregen in participants with geographic atrophy (ga) secondary to age-related macular degeneration (amd). all endpoints are assessed for the study eye unless otherwise indicated


Eligibility criteria:
inclusion criteria: * ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care * diagnosis of ga secondary to amd * bcva score \>/= 29 letters and \</= 60 letters in the study eye as assessed by etdrs * pseudophakic (study eye) exclusion criteria: * pregnancy or breastfeeding * history of cognitive impairment or dementia * any type of systemic disease or its treatment, in the opinion of the investigator, including any medical conditions that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the participant to a significant degree or put the participant at special risk ocular exclusion criteria for study eye: * any current or history of ocular disease other than ga that may confound assessment of the macula * history of retinal detachment * history of vitrectomy, glaucoma-filtering surgery, or corneal transplant * uncontrolled glaucoma or advanced glaucoma * any cataract surgery or intraocular surgery within 3 months prior to subretinal surgical delivery of opregen * history of other ocular or intraocular conditions that contraindicate the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications * any existing posterior segment device or implant

Keywords: geographic atrophy secondary to age-related macular degeneration