Kornimate/medical-research-clean huggingface dataset:
humira in psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: psoriatic arthritis (psa) is an inflammatory arthritis associated with psoriasis, which has a estimated prevalence of 0.3 - 1 %. the clinical course varies, but psa is often a progressive, erosive arthritis causing severe disability and increased mortality. the biologic treatment infliximab and etanercept have recently been introduced for treatment of psa and psoriasis, and current data indicate a higher efficacy than with previously available therapies. no clinical trials on adalimumab in psa are yet published (2005), but preliminary data are encouraging. the improved treatment options have increased the need for sensitive methods for diagnosis, monitoring and prognostication of psa, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. ultrasonography (us) and magnetic resonance imaging (mri) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this. the hypothesis is that adalimumab will be an effective treatment option for psa. novel imaging- and biomarkers can provide additional information, compared to clinical measures and radiography, concerning activity, destructive progression and prediction of therapeutic response in psa patients receiving adalimumab. the perspective is a potential improvement in diagnosis, monitoring and prognostication of patients with psa.


Eligibility criteria:
inclusion criteria: subject population: patients with active psa, fulfilling the following major criteria: 1. diagnosis of psa according to moll and wright criteria (moll and wright, 2. clinical active disease, defined as \>2 (of 76) swollen joints and \> 2 (of 78) tender joints 3. involvement of the hands (clinical swelling of 1 or more finger joint and/or 1 or more 1 sausage finger) 4. clinical indication for anti-tnf alpha therapy, according to treating physician 5. among other issues: age \>18 years; adequate birth control; no contraindications for anti-tnf alpha-therapy, no previous anti-tnf alpha-therapy, no other significant dermatological disorders than psoriasis.
single-blind, dose-ranging study of novel swine influenza virus vaccine in japanese adult subjects

Conditions: Influenza

Summary: this study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived h1n1sw monovalent vaccine in healthy adults based on emea/chmp criteria, and safety \& tolerability.


Eligibility criteria:
inclusion criteria: * healthy japanese adults aged 20 to 60 years exclusion criteria: * history of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients * administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior to study start * administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week * history of progressive or severe neurological disorders

Keywords: influenza a h1n1 subtype adult vaccine adjuvant swine-origin influenza a h1n1 virus
comparison of ways to prepare patients for decisions about joint replacement surgery

Conditions: Osteoarthritis

Summary: ministries of health consider wait lists for total joint replacement a top priority. research priorities to manage wait lists indicate the need to establish benchmarks that consider patient preferences. however, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indicators for, and the risks and benefits of, these procedures. these misperceptions can be corrected with the use of patient decision aids. when decision aids are used in combination with assessing surgical eligibility, there may be a reduction in unnecessary referrals for surgery either because the patient is ineligible or because the eligible candidates make informed decisions to forgo this option. the primary study objective is to evaluate the effect of patient decision aids (ptdas) on total wait times (wait times for surgical consultation, plus wait times for surgery) when used in combination with a general practitioner run clinic to screen patients with hip or knee osteoarthritis for surgical eligibility. major secondary objectives include determining (a) the effect of ptdas on surgery rates within two years, (b) the effect of ptdas on decision quality, and (c) cost-effectiveness of ptdas for total joint arthroplasty.

this was not indicated as required.

Eligibility criteria:
inclusion criteria: * patients referred for surgical consultation for hip or knee osteoarthritis * womac and hkpt scores indicate that pain and functional criteria are rated as moderate or severe, or there is radiographic evidence of joint damage exclusion criteria: * patients with inflammatory arthritis * patients who have had previous tja * patients unable to understand video/dvd decision aids due to deafness, blindness, cognitive impairment, or language barrier

Keywords: patient decision aids patient preferences osteoarthritis joint replacement waiting times
effects of music on motor skills of children with attention deficit and hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: physiotherapists have positive effects on motor skills, executive functions and symptoms of children with attention deficit and hyperactivity disorder. however, progression takes time due to the symptoms of the disease. physiotherapists need strategies to manage the symptoms of adhd. music can be used as a strategy because music is known to reduce the symptoms of children in this group. there is no study in the literature on how motor skills will be affected with musical accompaniment. the aim of this study is to compare motor skills performed with and without music in children with adhd. when we evaluate motor skills like in a treatment session, the usability of music as an environmental factor will be investigated according to the positive, negative or ineffective results of the music effect.

the american psychiatric association defines attention deficit and hyperactivity disorder (adhd) as one of the most common mental disorders affecting children and adults. the etiology of adhd is not fully known. attention deficit, hyperactivity and/or impulsivity are seen as the main symptoms of adhd. adhd is grouped into three subtypes according to these symptoms. these three subtypes consist of attention-deficit-dominant type, hyperactivity-dominant type, and combined type with both hyperactivity and inattention symptoms. researchers reported that 45-70% of children with adhd have problems in fine and gross motor skills. it is known that problems in motor skills are associated with main symptoms. balance, gait and postural control are affected in terms of gross motor skills. it has been observed that they perform more slowly in activities that require fine motor skills such as cutting, doing crafts or drawing, and in consecutive finger movements. in addition, handwriting disorders such as dysgraphia are seen in 70% of children with adhd. during the dual tasks, the sources of attention are divided. due to this division, the secondary task affects postural performance. music is one of the therapy options in some conditions and known as music therapy. it is used in many diseases and conditions such as dementia-alzamer, autism, cerebral palsy, cancer, prematurity, depression and adhd. now that music is known to reduce the symptoms of children with adhd, physical therapists may use music as a strategy. thus, the purpose of this study is to compare motor skills of children with adhd with and without music conditions.

Eligibility criteria:
inclusion criteria: * having been diagnosed with adhd combined type by a child psychiatrist * having adequate cognitive skills to understand the commands of the physiotherapist exclusion criteria: * having hearing and/or vision problems * having any neurological and/or orthopedic problems that would prevent him from performing the tests * having a psychiatric disorder other than adhd
safety, tolerability, and effectiveness of rasagiline mesylate in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: patients who completed the study tvp-1012/232 are eligible to enter the extension study to continue their rasagiline therapy for their parkinson's disease (pd). during this study the patient's safety, tolerability of rasagiline, and effectiveness of this therapy will be monitored.


Eligibility criteria:
inclusion criteria: • patients who completed evaluations of week 52 of the tvp 1012/232 protocol, where continued rasagiline therapy is warranted, in the opinion of the principal investigator exclusion criteria: • patients having suffered adverse effects that were probably drug-related in the tvp-1012/232 study
clinical evaluation of acupuncture treatment for negative symptoms of schizophrenia

Conditions: Schizophrenia

Summary: to explore the effects of combined traditional chinese and western medicine( chinese acupuncture combined with amisulpride tablets) on negative symptoms, cognitive function and social function in patients with schizophrenia, and the side effects and safety of chinese acupuncture combined with amisulpride tablets.

our research hypothesis：1. medically assisted acupuncture in schizophrenia can improve negative symptoms；2. drug assisted acupuncture therapy has better cognitive function in schizophrenic patients than single drug；3. schizophrene with acupuncture have fewer and lighter adverse reactions。this study was carried out only in shanghai mental health center. it was a parallel randomized study.schizophrene with negative symptoms were treated with atypical antipsychotic drug amisulpride, but still remained negative symptoms. using the mature chinese medicine therapy acupuncture auxiliary treatment, using the more reliable clinical evaluation method (the grader blind method: the raters were not sure which patients were the study group or the control group), compared with the single drug treatment, to observe the changes of negative symptoms and cognitive function, and the incidence of adverse reactions of acupuncture therapy, to explore the "new" auxiliary means for the treatment of negative symptoms, to guide clinical individualization and accurate medical treatment.

Eligibility criteria:
inclusion criteria: * the diagnosis of schizophrenia according to international classification diagnosis-10(icd-10) * patients at an age between 18～60 years old of han nationality exclusion criteria: * other psychiatric diagnoses * suffering from serious physical disease and can not accept the treatment * patients to be diagnosed according to icd-10 for substance abused, development delayed * inability to sign informed consent because of capacity due due to severe mental illness, significant psychomotor agitation or slowness test completion * claustrophobic * metal implantation in vivo

Keywords: schizophrenia ，acupuncture，amisulpride
clinical validation of an artificial intelligence tool to predict inversion time

Conditions: Cardiovascular Diseases

Summary: introduction: inversion-recovery (ir) magnetic resonance (mr) sequences are commonly used to perform late-gadolinium enhancement (lge) imaging during cardiac magnetic resonance (cmr) scans. inversion time (ti), i.e. the time between the 180° inverting pulse and the 90°-pulse, must be manually input to obtain optimal myocardium nulling. determinants of this value are patient's, sequence, and contrast characteristics, and the time after contrast injection. the identification of the correct ti is pivotal to quality images. the determination of ti is mostly based on experience, and it can be challenging in some diseases and for less experienced operators. aim of this study is to test in a clinical setting an artificial intelligence (ai) tool, which we developed to automatically predict ti in cmr post-contrast ir lge sequences, named "thaiti". thaiti performance will be evaluated in terms of 1) quality of images obtained using the ai-predicted ti with a 4-point likert scale; 2) quality of images obtained using the ai-predicted ti in terms of contrast-enhancement ratio, i.e. the signal intensity of enhanced/remote myocardium in cmr-lge images; 3) numbers of images that need to be reacquired; 4) average time duration of cmr-lge imaging.


Eligibility criteria:
inclusion criteria: * patients in whom cmr-lge is performed for a clinical reason * mixed cardiac conditions (including cardiomyopathies, ischemic heart disease, normal scans, focal and diffuse myocardial pathological processes) * both sexes * any age * availability of serum creatinine, measured within one month prior to cmr * provision of the written informed consent exclusion criteria: * non-contrast cmr * first-pass perfusion stress-cmr * absolute contraindication to cmr * inadequate overall image quality
comparative clinical study of drug-coating balloon strategy and drug-eluting stent strategy

Conditions: Coronary Artery Disease

Summary: the trial aims to evaluate the long-term clinical outcome of the dcb-only technique is non-inferior to the provisional t stenting with des in the patients who have 'true' bifurcation lesions.


Eligibility criteria:
inclusion criteria: 1. at least 18 years old; 2. evidence of myocardial ischemia and indications of pci, stable or unstable angina pectoris, or old myocardial infarction; 3. primary and bifurcated coronary artery lesions (medina classification 1,1,1 or 1,0,1 or 0,1,1); 4. visual angiography of the main branch reference vessel diameter ≥2.5mm, and ≤4.0mm;branch reference vessel diameter ≥2.0mm; 5. diameter stenosis of main and branch lesions ≥ 70%, and diameter stenosis of branch lesions ≥ 50%; 6. visual examination of residual stenosis of main branch lesions after pre-dilation ≤ 30% without vascular dissection or dissection with nhlbi classification a, b, c type. 7. if 2 bifurcation lesions meet the inclusion requirements, only 1 lesion can be included in the study, and the other lesion can be treated or not treated as a non-target lesion. exclusion criteria: 1. main branch or branching target lesions require treatment with more than one device (des or dcb); 2. there is more than 1 non-target lesion requiring intervention on the target blood vessel; 3. the distance between non-target lesion and target lesion is less than 10 mm; 4. main and branch lesions \> 26 mm or branch lesions length bbb\> mm; 5. left main lesion and its bifurcation lesion; 6. intra-stent restenosis or severe calcification; 7. st-segment elevation or non-st-segment elevation myocardial infarction 7 days before surgery; 8. severe heart failure (nyha-iv or left ventricular ejection fraction \<35%); 9. cardiogenic shock; 10. known to have renal failure (egfr \<30ml/min/1.73m2); 11. pregnant or lactating women, or women of reproductive age who had family planning or were unable to take adequate contraceptive measures during the study period; 12. any known allergic reactions or contraindications to the drug and coating or scaffold metal required for dcb in the study; 13. other des or dcb treatment contraindications; 14. failing to sign an informed consent or having an expected life of less than 12 months; 15. other researchers consider it inappropriate to participate in this study.
improving management of patients at high risk for osteoporotic fractures (0000-038)

Conditions: Osteoporosis

Summary: the purpose of this study is to assess the impact of disease management interventions on percent receiving a bone densitometry test and percent appropriately prescribed a medication for osteoporosis.


Eligibility criteria:
inclusion criteria: * members of the horizon blue cross blue shield of new jersey who are at risk for osteoporosis based on age (women age 65 or older, men and women age 45 or older who have a history of fragility fracture or have a history of taking oral glucocorticoids over 3 months). exclusion criteria: * individuals who are not members of horizon blue cross blue shield of new jersey and who otherwise do not meet the inclusion criteria.
study of palbociclib (pd-0332991) in renal impairment

Conditions: Renal Impairment

Summary: since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected to have much impact on palbociclib. however, the federal drug administration (fda) guidance recommends a study in subjects with renal impairment when the drug is likely to be used in patients with impaired renal function. palbociclib is intended for chronic use in cancer patients who may have some degree of impaired renal function.


Eligibility criteria:
inclusion criteria: * personally signed and dated informed consent document. * renal function calculated by the cockcroft gault equation: normal function (clcr \>=90 ml/min), mild: clcr \>=60 ml/min and \ =30 ml/min and \<60 ml/min, severe: clcr \<30 ml/min but not requiring hemodialysis. * subjects with normal renal function matched for age, weight, gender and race to subjects in impaired renal function groups. exclusion criteria: * any condition possibly affecting drug absorption. * renal allograft recipients.

Keywords: renal impairment auc cmax palbociclib normal matched subjects
effect of fibre products on appetite and weight

Conditions: Obesity

Summary: this study explores the nutritional effects of fibre. short chain fatty acid(scfa), such as propionate, are produced through the fermentation of fibre in the bowel. scfa are thought to have direct beneficial effects on the gut, appetite, weight and fat distribution. this study will look into these effects by conducting a dose finding study and then a randomised controlled study using healthy human volunteers.

this is a dose finding study in healthy overweight to obese human volunteers (bmi 25- 35) to find the level of oral supplementation with propionate that increases plasma propionate levels to 10x the current normal plasma level and use this dose of propionate in a randomised, placebo controlled double bind study. this study will compare propionate with fermentable and non fermentable carbohydrate. the outcome measures for this study will include assessments of appetite with feeding studies, measurement of insulin sensitivity using hyperinsulinaemic euglycaemic clamps and assessment of adipose tissue distribution using mri scans and adipose tissue biopsy to determine changes in proliferation and differentiation of adipocytes.

Eligibility criteria:
inclusion criteria: * healthy male and female volunteers aged between 21 and 65 years exclusion criteria: * weight change of more than 3kg in the preceding 2 months * current smokers * substance abuse * excess alcohol intake * pregnancy * diabetes * cardiovascular disease * cancer * gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome * kidney disease * liver disease * pancreatitis * use of medications including: anti inflammatory drugs or steroids, cholesterol lowering medication, androgens, phenytoin, erythromycin or thyroid hormones.

Keywords: obesity short chain fatty acids appetite body weight insulin sensitivity propionate propionate ester
safety study of an oral pro-bonetm, administered to post menopausal osteopenic women

Conditions: Osteopenia

Summary: recent studies have shown that inhibition of aquaporine-9 channels may ameliorate the bone degradation process. pro-bone is an aq - 9 channels inhibitor. this study is design to evaluate the safety of pro-bone.


Eligibility criteria:
inclusion criteria: * bmd as measured by dexa at screening, should range between (-1)to (-2.5) sd from normal values. * at least 12 months of spontaneous amenorrhea or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. * study participants not taking estrogen alone or estrogen/progestin containing drug products. * study participants not taking any anti-osteoporosis treatment for at list one year. * the following washout periods should be before baseline assessments are made for subjects previously on estrogen alone or estrogen/progestin containing products: 1. 8 weeks or longer for any prior use of estrogen and/or progestin products. 2. 6 months or longer for prior progestin injectable drug therapy. 3. women between 45 and 65 years (inclusive) of age. 4. bmi 22-30 (inclusive) 5. non-smoking (by declaration) for a period of at least 6 months. 6. subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study. * subjects who provide written informed consent. exclusion criteria: * women have documentation of a positive screening mammogram (obtained at screening or within 9 months of study enrolment) or abnormal clinical breast examination prior to enrolment in clinical studies. * known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications. * any clinically significant abnormality, upon physical examination or in clinical laboratory test, at screening visit. * known history of drug or alcohol abuse according to participant declaration at screening visit. * any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the principal investigator. * subjects who are non-cooperative or unwilling to sign consent form.

Keywords: osteopenia
complement c5 mab in the treatment of anti-gbm disease

Conditions: Autoimmune Diseases

Summary: anti-gbm disease is the most severe form of glomerulonephritis. despite of the standard treatment including plasmapheresis and immunosuppressant, 70% of the patients still go into end-stage kidney disease. complement has been shown to participate in the pathogenesis of anti-gbm disease. this study aims to the investigate the therapeutic effects and safety of c5 monoclonal antibody in the treatment of anti-gbm disease.

anti-glomerular basement membrane (anti-gbm) disease is the most severe form of autoimmune glomerulonephritis, characterized by the production of autoantibodies targeting the components of basement membrane within the kidney and/or the lung.patients with anti-gbm disease typically present rapidly progressive glomerulonephritis, and often accompanied by lung hemorrhage. the hallmark of the disease is the linear deposition of igg along the gbm on kidney biopsy. complement activation is a pivotal step for kidney injuries during the development of human anti-gbm disease. our previous study showed that the the levels of plasma sc5b-9 and urinary c5a were positively correlated with the serum creatinine at presentation and the percentage of crescents in glomeruli. eculizumab is a recombinant humanized monoclonal antibody that specifically binds to a c5 terminal complement and inhibits the cleavage of c5 to c5a and c5b through complement activation. there are a few case reports showing therapeutic effects in anti-gbm disease. this trial will aim to evaluate the efficacy and safety of eculizumab plus standard treatment in anti-gbm disease.

Eligibility criteria:
inclusion criteria 1. positive circulating anti-gbm antibody, with proteinuria or hematuria or any clinical signs of kidney injuries. 2. biopsy-proven anti-gbm disease with or without positive circulating anti-gbm antibodies 3.16\~65 years old exclusion criteria 1. allergic to eculizumab, mouse protein or the investigational drug and any of its excipients; 2. uncontrolled meningococcal infection,or those who have not received meningitis prophylactic antibiotic treatment or meningitis vaccination; 3. diagnosis of anti-gbm disease for more than 12 weeks before signing the informed consent form; 4. anca-positive; 5. pregnant or lactating 6. received investigational drug within 30 days or 4 half-lives (whichever is longer) prior to screening; 7. other serious poorly controlled comorbid diseases that affect the compliance of the trial protocol or the interpretation of results within 3 months prior to screening, including cardiovascular and cerebrovascular diseases, lung disease, etc.; 8. presence of any medical history or disease that, in the opinion of the investigator, may expose the patient's participation in the study to an unacceptable risk;

Keywords: complement c5 anti0-gbm disease