Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of micafungin for injection in prevention and treatment of fungal infection in hematological tumors

Conditions: Hematological Tumors Patients With High Risk Factors of Invasive Fungal Disease

Summary: this is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors.

this is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors. researchers screened suitable subjects according to the admission criteria, and after signing the informed consent form, micafungin sodium for injection was used for preventive or empirical treatment. during the treatment period, subjects who need to change the treatment plan due to uncontrollable infection or other reasons will withdraw from this research and the researchers will decide the follow-up treatment plan.all subjects were monitored for efficacy and safety according to the visit plan during the research.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, male or female 2. patients with hematological tumors 3. neutropenia: the absolute neutrophils count (anc) in peripheral blood was 0.5×109/l or was expected to be anc\<0.5×109/l 48 hours later. 4. fever: single measurement of oral temperature ≥ 38.3℃ (axillary temperature ≥ 38.0℃) or oral temperature ≥ 38.0℃ (axillary temperature ≥ 37.7℃) lasts for more than 1h 5. patients with high risk factors of ifd (invasive fungal disease), such as patients treated with allo-hsct, patients with acute leukemia (including mds) undergoing primary induction or rescue chemotherapy, patients with expected granulocytosis lasting more than 10 days, patients with severe granulocytosis or patients with severe aplastic anemia receiving antithymic globulin (atg) therapy or hsct therapy, etc. exclusion criteria: 1. the patient is being treated with an antifungal drug 2. people who are known or suspected to be allergic to echinocandins 3. the infection is suspected to be caused by parasites, viruses or mycobacterium tuberculosis. 4. existing drug sensitivity results suggest that patients resistant to micafungin 5. severe chronic liver disease with child-pugh grade c 6. fever caused by tumor 7. micafungin in the treatment of fungal infections caused by cryptococcus, zygomycetes and trichospora that are ineffective 8. removal of the central venous catheter can effectively relieve fever, and it is difficult to determine whether micafungin is effective or not. 9. patients who were not considered suitable for the research

Keywords: hematological tumors invasive fungal disease
optimising outpatient care in mild to moderate psoriasis (pso-top)

Conditions: Mild to Moderate Psoriasis

Summary: a topical treatment optimisation programme (ttop) has been developed by the sponsor together with patient boards and an expert advisory board to overcome non-adherence problems.

a topical treatment optimisation programme (ttop) has been developed by the sponsor together with patient boards and an expert advisory board. this tool is created to address patients' non-adherence in topical therapy and the resulting underperformance of such treatments in controlling psoriatic disease. the study addresses the effect of the relationship between the patient and the health care professional, one of the important factors that can affect treatment adherence and therapeutic efficacy. the ttop will be compared to standardised regular care (called 'non-ttop'). it is intended to clinically show the importance of an optimised contact between the patient and health care professional.

Eligibility criteria:
inclusion criteria: * male and female patients aged at least 18 years * mild to moderate active plaque psoriasis with pga ≥ 2 on the 7-point scale by langley and ellis and a body surface area (bsa) of ≤ 10% * topical psoriasis treatment with coal or tar preparations, tazarotene, steroids, or vitamin d analogues, or combinations of steroids and vitamin d analogues (except gel combination products containing 50 micrograms calcipotriol/0.5mg betamethasone/g) or dithranol and its combination preparations over the last 8 weeks prior to visit 1 (week 0) * written informed consent to participate in the study has been given prior to any study related procedures exclusion criteria: * severe renal insufficiency * severe hepatic disorders * known hyper calcaemia * erythrodermic, exfoliative, pustular or guttate psoriasis * facial or genital psoriasis * fulfilment of at least one contraindication according to the summary of product characteristics of daivobet®/dovobet® gel * pregnant and/or breast-feeding women * hypersensitivity to the active substances or to any of the excipients * suspected non-compliance with the clinical study procedures * current participation in another clinical study * systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to visit 1 (week 0): * etanercept - within 4 weeks prior to visit 1 (week 0) * adalimumab, alefacept, infliximab - within 2 months prior to visit 1 (week 0) * ustekinumab - within 4 months prior to visit 1 (week 0) * experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to visit 1 (week 0) * phototherapy within the following time periods prior to visit 1 (week 0): * puva - within 4 weeks prior to visit 1 (week 0) * uv-b - within 2 weeks prior to visit 1 (week 0)
using duke activity status index (dasi) to select optimal cardiac stress tests

Conditions: Ischemic Heart Disease

Summary: cardiac stress testing with functional nuclear imaging is an invaluable technique in the diagnostic and prognostic evaluation of patients with known or suspected ischemic heart disease. selection of the appropriate type of nuclear stress test: exercise stress myocardial perfusion imaging (mpi) versus pharmacologic stress mpi is crucial for not only diagnostic accuracy and prognostic evaluation, but also for sound clinical decisions and resource utilization. the duke activity status index (dasi) is a 12-item questionnaire that utilized self-reported physical work capacity to estimate peak metabolic equivalents (mets) and has been shown to be a valid measurement of functional capacity. the investigators hypothesized that the dasi may be the screening tool that evaluates functional capacity and guides selection of the optimal stress mpi study.


Eligibility criteria:
inclusion criteria: * age \> 18 exclusion criteria: * none

Keywords: ischemic heart disease duke activity status index stress myocardial perfusion imaging
prospective, single-arm, multi centre observations ultimaster des registry

Conditions: Coronary Artery Disease

Summary: the e-ultimaster will further validate the safety and efficacy of ultimaster des system in unselected patients representing everyday clinical practice. also the study will assess the impact of non-compliance with dual antiplatelet therapy, one month after stent implementation (frequently observed in every day clinical practice), on stent thrombosis.

all consecutive patients suitable for treatment with des according to hospital routine practice in centres across the world that agree to participate in the e-ultimaster registry will be treated with ultimaster des. secondary objectives evaluation of worldwide utilization of des, detection of rare events in representative patient population, identification of predictors of major advers events, assessment of radial access site utilization and its impact on bleeding and vascular complications, assessment of procedural particularities and patients pathology in wide geographic area, assessment of duration and type of dapt, assesment of the performace of ultimaster des is patients lesions subsets, assessment of possible benefits of biodegradable polymer in lager complex patiets/lesions subset and assessment of sirolimus efficacy in different races. data will be collected in a e-crf and online monitoring will be done. audits will be allowed by sponsor or qualified designees.

Eligibility criteria:
inclusion criteria: * 18 years or older * eligible for percutaneous coronary intervention using des (and rvd matches available ultimaster des sizes) * informed about the nature of the study and agreess to its provisionss and has provided written informed consent as approved by the institutional review board / ethics committee of the respective clinical site, wherever such requirement exists. exclusion criteria: * following instruction for use

Keywords: ultimaster registry des dapt
replacing protein via enteral nutrition in a stepwise approach in critically ill patients

Conditions: Critical Illness; ARDS; Septic Shock; Multiple Trauma; Seizure Disorder; Hemorrhagic Shock

Summary: in this study, we will explore the feasibility of a randomized controlled trial that will compare high protein dose from icu day 6 to 14 with moderate protein intake.

patients will be recruited on day 1-2 of icu admission. on day 5, patients will be randomized into one of the two intervention arms; replenish protein group: patients randomized to this group will receive 2 g of protein/kg/day (acceptable range 1.8 - 2.2 g of protein/kg/day) for day 6-14. standard protein group: patients randomized to this group will receive protein at 0.8 - 1.0 g of protein/kg/day for day 6-14

Eligibility criteria:
inclusion criteria 1. age ≥ 18 years 2. mechanically ventilated 3. receiving enteral feeding via nasogastric/orogastric or duodenal or peg or jejunostomy tubes and 4. expected to stay ≥ 1 week in the icu exclusion criteria 1. lack of commitment to ongoing life support, which includes; * terminal illness (malignancy or irreversible condition with 6 month mortality \> 50%) * dnr order in the first 48 hours and brain death within 48 hours of admission) (don't include the presence of a "do not resuscitate" order alone, if there is a commitment to ongoing life support). 2. patients not fed within 48 hours of admission 3. patients on total parenteral nutrition (tpn) 4. patients being fed orally 5. chronic renal failure 6. chronic liver disease 7. renal replacement therapy 8. pregnancy. 9. kidney transplant 10. post-liver transplant. 11. post cardiac arrest. 12. burn patients. 13. prisoners screened patients will be screened again for eligibility at day 5, should be mechanically ventilated and expected to stay ≥ 3 days in the icu. at this point, patients will be excluded if they meet the following; 1. new onset renal replacement therapy. 2. acute kidney injury (serum creatinine \> 3 times the preacute level or serum creatinine \>350mmol/l with a recent increase of \>44 mmols/l) 3. significant liver impairment

Keywords: enteral nutrition, intensive care units, caloric restriction, insulin, mortality, protein catabolism
allogeneic umbilical cord blood therapy for stroke

Conditions: Stroke

Summary: this open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (ucb) therapy for patients with stroke.

stroke is one of the most common etiologies causing disability in developed countries. there remains no proven treatments except tissue plasminogen activator currently. based on promising results of cell therapy in animal stroke models, efforts to apply cell therapy for patients with stroke has been made. ucb possess various stem or progenitor cells and is known to secrete neurotrophic factors to repair injured brain. this clinical research aims to determine the safety and efficacy of allogeneic ucb for stroke.

Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke * onset duration over 12 months * hemisphere lesions except brain stem and cerebellar lesions * national institute health stroke scale: 10 to 15 exclusion criteria: * possibility of hypersensitivity drugs used in this study * uncontrolled hypertension or cardiovascualr diseases * malignant cancer * renal or hepatic dysfunction (consultation to specialist in nephrology or gastroenterology in case of renal or hepatic dysfunction) * severe pulmonary dysfunction * traumatic brain injury * lack of matched ucb
corifollitropin alfa compared to daily rfsh in poor responders undergoing icsi

Conditions: Subfertility

Summary: corifollitropin alfa has been shown to result in significantly more oocytes compared to daily recombinant follicle stimulating hormone (recfsh) (devroey et al., 2009), probably due to the higher circulating fsh activity during the first days of stimulation. for this reason, the use of corifollitropin alfa might be beneficial in poor responders in whom the number of oocytes retrieved is crucial for success. the purpose of this study is to evaluate the effectiveness of corifollitropin alfa treatment compared to daily recfsh in terms of the number of oocytes retrieved in a defined population of poor responder patients undergoing intracytoplasmic sperm injection (icsi) using gonadotrophin releasing hormone (gnrh) antagonists.


Eligibility criteria:
inclusion criteria: 1. proven poor responders of couples with an indication for cos 2. ≥ 18 and \< 45 years of age 3. bmi ≥ 18 and ≤ 32 kg/m2 4. regular spontaneous menstrual cycle (24-35 days) 5. availability of ejaculatory sperm (use of donated and/or cryo-preserved sperm is allowed) exclusion criteria: 1. pgd or pgs 2. tese
erp based single-dose predictions of stimulants

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study was to see if the clinical outcome of stimulant medication (methylphenidate) in pediatric attention deficit hyperactivity disorder can be predicted on the bases of changes in event related potentials (erps) induced by a single dose of stimulant medication. (erps are extracted from electroencephalographic (eeg) registrations during the performance of an attention task).

in the pediatric neuropsychiatric clinic of ostfold hospital trust, norway, patients diagnosed with attention deficit hyperactivity disorder are tested with quantitative eeg (qeeg) and erps to supplement the neuropsychological examination. in the majority of cases a systematic four weeks trial on stimulant medication is offered, and the clinical effects are evaluated at the end of the try-out period. this procedure is a clinical routine. in this study patients and parents were asked if they were willing to complete a second qeeg/erp test on a single dose of stimulant medication shortly before the onset of the four weeks trial. they were explained that the aim of the study was to search for predictors of clinical response. they were also informed that this second test was completely voluntary. (in fact the vast majority were quite enthusiastic). the patients were characterized as responders (res - medication continued) or non-responders (non-res - medication stopped) based on explicit criteria. the single-dose induced changes in erps (and behavioral parameters from the attention test; number of errors, reaction times) were examined, and differences between res and non-res were calculated. if the analysis of data show that one or several variables are significantly different in res and non-res with large effect sizes, these findings may eventually result in the development of a useful clinical tool.

Eligibility criteria:
inclusion criteria: * patients referred to the clinic diagnosed with attention deficit hyperactivity disorder. cases with comorbid diagnoses such as emotional or behavioral disorders, learning disabilities or high functioning autism are included. exclusion criteria: * patients with intelligence coefficients below 70 or a diagnosed neurological disease are excluded.
mri of sacroiliac joints: evaluation of accuracy of dixon sequences in the diagnosis of axial spondyloarthritis

Conditions: Spondyloarthritis

Summary: the investigators hypothesize that the t1 dixon post-gadolinium and t2 dixon sequences will show good diagnostic performances for active sacroiliitis compared to the reference test (short tau inversion recovery) and clinical-biological criteria, which will allow a better diagnosis of active sacroiliitis


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * the patient is at least 18 years old * the patient has a clinically diagnosed axial spondyloarthritis (axspa) (asas or amor classification) * patient has an active axspa (basdai\>4) exclusion criteria: * the subject is participating in another study, or is in a period of exclusion determined by a previous study * the subject refuses to sign the consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * the patient is pregnant or breastfeeding * the patient has a contra-indication
study to evaluate the abuse potential of act-541468 in healthy recreational drug users

Conditions: Healthy Recreational Drug Users

Summary: this placebo- and active controlled study will investigate the abuse potential of act-541468 in healthy recreational drug users


Eligibility criteria:
inclusion criteria: * signed informed consent prior to any study-mandated procedure * male or female healthy subjects, 18-55 years of age (inclusive) at screening * body mass index of 18.0-33.0 kg/m2 (inclusive) at screening and a minimum weight of 50.0 kg at screening * current sedative users who have used sedatives (e.g., benzodiazepines, zolpidem, eszopiclone, gamma-hydroxybutyrate, barbiturates) for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least ten times in their life and at least once in the 12 weeks before screening * women of childbearing potential must consistently and correctly use a reliable method of contraception with a failure rate of \< 1% per year, be sexually inactive, or have a vasectomized partner * women of non-childbearing potential * male subjects are required to use a medically acceptable method of contraception throughout the entire study period and for at least 90 days after last study drug administration exclusion criteria: * history of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) * positive hiv or hepatitis b/c test at screening * female subjects who are currently pregnant or lactating or who are planning to become pregnant within 1 month of the last study treatment administration * modified swiss narcolepsy scale total score \< 0 at screening or history of narcolepsy or cataplexy * substance or alcohol dependence within 2 years prior to screening or prior participation in a substance or alcohol dependence rehabilitation program * subjects who have a positive urine drug screen at admittance to the qualification or core phase * any sleep-disorder including self-reported insomnia disorder, breathing-related sleep disorders, restless legs syndrome (rls), nightmare disorder, non-rapid eye movement (rem), sleep arousal disorders, rem sleep behavior disorder, circadian rhythm sleep-wake disorders, or narcolepsy * any of the following sleep-50 questionnaire scores at screening: * ≥ 15 on apnea subscale; * ≥ 7 on narcolepsy subscale; * ≥ 7 on rls or periodic limb movement disorder subscale; * ≥ 8 on circadian rhythm subscale; * ≥ 7 on sleepwalking subscale; * ≥ 3 on item 32 and ≥ 9 on items 33 to 35 (i.e., on nightmare subscale); * ≥ 15 on impact subscale. * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
an efficacy and safety study evaluating tofacitinib with and without methotrexate compared to adalimumab with methotrexate

Conditions: Rhematoid Arthritis

Summary: to assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. to compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. to compare effects on all health outcomes measures in the study. to evaluate the safety and tolerability of tofacitinib and adalimumab. to evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.


Eligibility criteria:
inclusion criteria: * have moderate to severe rheumatoid arthritis * on methotrexate but inadequately controlled * subjects must not have active tuberculosis or an inadequately treated tuberculosis infection * subjects must use contraception exclusion criteria: * subjects who have been previously treated with adalimumab or tofacitinib * subjects with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. * subjects with specific laboratory test abnormalities * subjects with specific types of infections
safety and efficacy of pravastatin in relapsing-remitting multiple sclerosis

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: therapeutic strategies for multiple sclerosis (ms) are essentially based on the use of immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is quite limited, they are not well tolerated and they have a very high cost. recent works showed an immunomodulatory effects of hmg-coa reductase inhibitors (the so-called "statins"). in experimental allergic encephalopathy, a murine model of ms, statins inhibit the onset and progression of the disease through a shift from th1 towards th2 cytokine production. other in vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the blood brain barrier. furthermore, in an open labeled human study in ms, statin regimen was associated with a decreased lesional activity assessed by mri. statins are well tolerated drugs, used for many years, with a low cost and with a putative efficacy in ms. the investigators suggest to test the pravastatin safety and efficacy on mri criteria in a double-blind, placebo-controlled study in 40 patients with a relapsing-remitting ms.


Eligibility criteria:
inclusion criteria: * relapsing remitting ms with diagnosis defined by the mcdonald criteria (mcdonald et al., 2001) with no current disease modifying therapy (interferon, copaxone or immunosuppressant drugs) since at least 3 months and an edss score \< 5. * at least one gadolinium positive lesion on the mri of the selection phase is needed. * no current statin therapy. * normal renal and hepatic biological tests. * no current pregnancy