Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of mcs in healthy volunteers

Conditions: Healthy

Summary: this study is to examine the pharmacokinetics, absorption and serum concentrations of mcs and other components after once-daily oral dosing of mcs.

this study is an open-label, multiple-dose study, whose objective is to examine the pharmacokinetics of mcs and other components after once-daily oral dosing for 21 days. subjects will undergo a 14-day washout phase and then enter the 21-day treatment phase. during the treatment phase, subjects will receive mcs, once-daily within one hour after the evening meal. after completion of the treatment phase, subjects will enter a post-treatment 42-day washout phase. throughout each of these phases, blood samples will be collected and assayed for concentrations of mcs and other components. the duration of protocol participation is expected to be 77 days for each eligible subject who completes the study.

Eligibility criteria:
inclusion criteria: * normal healthy volunteers * 18 years of age or older exclusion criteria: * subjects who can not comply with the study procedures or sign the informed consent form

Keywords: pharmacokinetics pk mcs benign prostatic hyperplasia multi-carotenoids healthy subjects
biomarkers of sleep-wake cycle in prodromal alzheimer's disease: role in cognitive decline?

Conditions: Neuropathology

Summary: alzheimer's disease (ad) is characterised by a progressive loss of memory and cognitive function. in the early stages of ad, there is a progressive accumulation of molecules: β-amyloid peptides (aβ) in the brain. there is a link between the accumulation of aβ peptides and the deterioration of sleep, but current knowledge does not confirmed this link. the objective of this study is to define whether there is a link between cognitive decline and sleep disorders. if a correlation is found, this could allow earlier treatment of sleep disorders in the longer term in order to slow the development of ad.


Eligibility criteria:
inclusion criteria: * diagnosis of mild alzheimer's disease with a mini mental state (mms) between 21-30 * the presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries * having a neurological assessment and/or follow-up requiring blood and cerebrospinal fluid (csf) sampling with biomarkers for diagnostic purposes * patient who had a lumbar puncture less than one year ago or patient with a scheduled lumbar puncture as part of care * signed informed consent * able to carry out all visits and follow study procedures * affiliation to the french social security system exclusion criteria: * genetic form of alzheimer's disease * insufficient clinical and paraclinical information for the diagnosis of ad * anticholinesterase and/or memantine treatment or on stable doses for at least 3 months * use of antidepressants, anxiolytics, hypnotics, neuroleptics, 15 days before inclusion * patient living in a nursing home * illiteracy or inability to perform psycho-behavioural tests * major physical or neurosensory problems that may interfere with the tests * initial contraindication to diagnostic lumbar puncture (lp) (spinal surgery, skin infection, haemostasis abnormality, intracranial hypertension, severe coagulation disorders, curative anticoagulant therapy, severe liver failure) * refusal to perform a diagnostic lumbar puncture * contraindication to the use of e-celsius: people weighing less than 40 kg, with intestinal disorders, with known swallowing disorders * patient deprived of liberty, by judicial or administrative decision; * major protected by law; * patient in a period of relative exclusion from another protocol or for whom the maximum annual compensation of €4500 has been reached; * refusal to participate in the protocol.

Keywords: cognitive composite score sleep biomarkers cognitive decline
the impact of integbasic physical fitness rated neuromuscular training intervention on the of military personnel

Conditions: Chronic Ankle Instability,CA; Basic Physical Fitness

Summary: objective: the study aims to evaluate the efficacy of an 8-week integrated neuromuscular training intervention on the fundamental physical fitness parameters of military personnel, encompassing strength, velocity, agility, and equilibrium. methodology: the research randomly allocated 20 military students from the national university of defense technology into two cohorts, utilizing an experimental methodology with longitudinal assessments at the onset, midpoint, and conclusion of the intervention to quantitatively assess the influence of the integrated neuromuscular training on velocity and agility. participants in both the experimental and control groups were evaluated one week prior to the intervention, at the fourth week, and one week post-intervention. statistical analysis involved a two-factor repeated measures anova to compare measures across the three time points, while paired-sample t-tests were applied for pre-post comparisons. the experimental group engaged in an 8-week integrated neuromuscular training regimen, consisting of three 90-minute sessions per week, culminating in a total of 24 sessions. concurrently, the control group adhered to a conventional physical training schedule, also structured around three 90-minute sessions per week, over the same 24-session period, thereby ensuring parity in total training duration and frequency between the experimental and control groups.


Eligibility criteria:
inclusion criteria: * age between 18-24 years old * students with corresponding military status * meeting the diagnostic criteria for functional movement screen assessment * no history of psychological or psychiatric disorders, and not participating in other physical training during the experimental period * capable of cooperating to complete the corresponding training and testing, and will not withdraw from the experiment without cause exclusion criteria: * major sports injuries within the past 2 years, including fractures, ligament tears, muscle or tendon ruptures, and recurrent dislocations of joints * patients with cardiovascular and cerebrovascular diseases and related internal organ conditions * failure to pass the functional movement screen test * individuals with injuries or discomfort in other areas

Keywords: integrated neuromuscular training military population basic physical fitness
stellate ganglion block and cerebral vasospasm

Conditions: Aneurysmal Subarachnoid Hemorrhage; Stellate Ganglion Block; Cerebral Vasospasm

Summary: at present, cerebral vasospasm (cvs) is the main cause of delayed cerebral infarction (dci), which leads to high disability and mortality rate after aneurysmal subarachnoid hemorrhage. as a consequence, the key of reducing dci is to prevent cvs. but unfortunately, despite years of efforts, the prevention and treatment of cvs is still a major clinical dilemma and various ways of treatment are still being explored. recent studies have shown that stellate ganglion block (sgb) can dilate cerebral vessels and alleviate the impact of existing cvs. however, there is no study to evaluate the effect of early application of sgb on the improvement and prevention of cvs after asah.

cerebral vasospasm refers to the extensive segmental or diffuse contraction of cerebral vasculature after asah, and cerebral blood flow is significantly reduced, which can lead to delayed cerebral ischemia (dci) or delayed ischemic neurological dysfunction (dind). past studies have shown that if cerebral vasospasm occurs in patients with asah, the proportion of ischemic brain injury can be as high as 20%-30%.obviously, prevention and treatment of cvs are the key to reducing the disability and mortality of asah.

Eligibility criteria:
inclusion criteria: * age range: 18-65 years old; * within 48 hours after onset of asah,and planning surgical treatment(aneurysm clipping); * preoperative hunt-hess grade 2-3 * sign informed consent. exclusion criteria: * asa \> grade iii; * patients with posterior circulation aneurysm, ophthalmic aneurysms or internal carotid aneurysms; * patients with multiple aneurysms; * patients with severe coagulation dysfunction; * patients with trauma and local infection in the nerve block area; * local anatomic structure changes (neck structure changes caused by radiotherapy, chemotherapy and surgery); * mca stenosis or infarction was found by preoperative imaging; * patients with poor temporal window signal revealed by preoperative tcd (clear waveform image could not be obtained); * allergy to known local anesthetics; * pregnant and lactating women.

Keywords: cerebral vasospasm stellate ganglion block
assessment of voluntary and reflex cough in patients with als

Conditions: ALS; Cough

Summary: this study aims to assess the presence and the intensity of voluntary and cough reflex in patients with amyotrophic lateral sclerosis (als), comparing the results with the healthy control group. the assessment of the cough is fundamental to verify the mechanism of airways protection which is particularly compromised in als patients. objective parameters of voluntary and reflex cough would be measured by the spirometer. the reflex of cough would be elicited by a solution of citric acid through an ultrasonic nebulizer.

protocol: 1. volitional cough assessment by spirometer (pony fx- cosmed): a) forced vital capacity (fvc); b) volume tidal; c) maximum espiratory pressure (mep); d) maximum inspiratory pressure (mip); e) peak of cough expiratory flow. 2. cough reflex would be trigged by the inhalation of 0.4m of citric acid solution using the ultrasonic nebulizer (mo-03 norditalia elettromedicali) connected with the spirometer and the nebulizer via a bidirectional valve. it would be measured the peak of cough expiratory flow. participants: it would be recruited 60 subjects at the irccs ospedale san camillo venezia (italy). all participants have to provide informed consent independently. the study group is composed by thirty participants with diagnosis of als and the severity score of amyotrophic lateral sclerosis functional rating scale (alsfrs). the control group consist of thirty healthy subjects matched by aged and sex with the study group. statistical consideration: the variables measured will be summarized by means and standard deviations or by proportions. numeric variables mip-mep-fvc-vt-pcef will be analyzed using the shapiro-wilk test to verify the normality of distribution. depending on the outcome, for the comparison between groups will be used or the t-test (parametric) or the test of mann whitney (non-parametric) for independent samples.

Eligibility criteria:
inclusion criteria: * diagnosis of als * consensus exclusion criteria: * smokers * oxygen therapy * invasive ventilation * allergy of citrus * asthma

Keywords: als and dysphagia als and cough cough reflex test
discovery of new early detection biomarkers from peripheral blood of acute respiratory distress syndrome(ards)

Conditions: Acute Respiratory Distress Syndrome

Summary: acute respiratory distress syndrome (ards) has a very poor prognosis and high mortality. to improve the early diagnosis of ards, there is an urgent need for novel biomarkers of ards. this project aims to detect novel biomarkers from peripheral blood , which can improve the early diagnosis and develop a more efficient therapy to enhance ards patient survival rate. clinical data and blood sample were recorded before treatment and after treatment. acute physiology and chronic health evaluation iii (apache iii) scores were calculated at enrolment. different kinds of lymphocytes from blood samples would be detected by flow cytometry ,which could be used for discovering high sensitivity and specificity ards biomarker.

background acute respiratory distress syndrome (ards) has a very poor prognosis and high mortality. to improve the early diagnosis of ards, there is an urgent need for novel biomarkers of ards. this project aims to detect novel biomarkers from peripheral blood , which can improve the early diagnosis and develop a more efficient therapy to enhance ards patient survival rate. clinical data and blood sample were recorded before treatment and after treatment. acute physiology and chronic health evaluation iii (apache iii) scores were calculated at enrolment. different kinds of lymphocytes from blood samples would be detected by flow cytometry ,which could be used for discovering high sensitivity and specificity ards biomarker. eligibility ages eligible for study: 18 years and older genders eligible for study: both accepts healthy volunteers: yes sampling method: probility samples study population patients who have ards and admitted in hospital primary outcome measures: ilc2 and ilc3 number from peripheral blood of ards patients secondary outcome measures: apache iii score \[ time frame: baseline, 1week, 2 weeks \] pao2/fio2 ratio\[ time frame: baseline, 1week, 2 weeks \] mortality or multi-organ failure \[ time frame: 1 month \] groups: 1. mild ards pao2/fio2=201～300 mmhg，and peep or cpap≤5 cm 2. moderate ards pao2/fio2=101～200 mmhg，and peep≥5 cm h2o 3. severe ardspao2/fio2≤100 mmhg，and peep≥10 cm h2o 4. healthy

Eligibility criteria:
inclusion criteria: * ages eligible for study: 18 years and older genders eligible for study: both accepts healthy volunteers: yes sampling method: probility samples study population：patients who have ards and admitted in hospital criteria：inclusion criteria:the berlin definition of acute respiratory distress syndrome,ats definition of severe pneumonia exclusion criteria: * age below 18 years,pregnancy,expected survival under 24 hours

Keywords: ards
a study of mircera in the treatment of anemia in patients with chronic kidney disease not on dialysis

Conditions: Anemia

Summary: this study will assess the efficacy and safety of subcutaneous mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. the anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * chronic kidney disease; * anemia; * not on dialysis therapy; * not receiving epoetin. exclusion criteria: * women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of another investigational drug within 4 weeks before screening, or during the study period.
blastic plasmacytoid dendritic cell neoplasm (bpdcn) international registry

Conditions: Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Summary: blastic plasmacytoid dendritic cell neoplasm (bpdcn) is a very rare hematologic malignancy. despite recent advances, at present there is no consensus on the optimal treatment of bpdcn. the optimal therapy of disease remains to be determined, and due to the rarity of cases, there is a need for international collaboration to collect data on bpdcn clinical presentations, diagnostics, treatment regimens and outcomes. therefore, the objectives of this study are: (1) to build a large database of patients with bpdcn, (2) to investigate the characteristics and outcome of the disease with different treatment regimens, (3) to evaluate prognostic factors, and (4) to generate data-based prospective treatment recommendations.

blastic plasmacytoid dendritic cell neoplasm (bpdcn) is a rare hematologic malignancy. in 2008, it was recognized by the who as a distinct entity and separately listed in the group of acute myeloid leukemias and related precursor neoplasms. the final diagnosis of bpdcn relies on a compatible immunophenotype. the triple positive cd4+cd56+cd123+ phenotype associated with negativity for lineage-specific markers is a minimum requirement for defining bpdcn. the highly specific marker bdca2/cd303, as well as other plasmacytoid dendritic cell-associated antigens (e.g. tcl1 and cd2ap), might be of great support to exclude potential mimickers of bpdcn (acute myeloid and monocytic leukemias, precursor lymphoblastic t-cell leukemia/lymphomas and t- and nk/t cell lymphomas. at present, there is no consensus on the optimal treatment of bpdcn. the majority of patients receive multi-agent chemotherapy with aml or all treatment regimens, while a few patients undergo allogeneic haematopoietic stem cell transplantation (hsct). in recent years, different novel and innovative therapies are in development to target surface molecules in bpdcn. the patients are still in need of better treatments and the optimal therapy of disease remains to be determined. this is a multicenter, international prospective and retrospective registry with the aim of collecting data of patients with a diagnosis of bpdcn globally. patients will be recruited directly by the national study groups / participating centers. participating centers will collect and verify informed consent of all prospective patients enrolled at their center. the following data will be collected through questionnaires: 1. patient characteristics 2. bpdcn characteristics 3. treatment details 4. outcomes 5. cause of death 6. end of data collection quality control and data management will be conducted by the immune oncology research institute.

Eligibility criteria:
inclusion criteria: * diagnosis of bpdcn * signed informed consent form for prospective patients exclusion criteria: -
a multi-center, randomized, double-blind, double-dummy clinical study to evaluate the safety and efficacy of prulifloxacin film-coated tablet for the treatment of acute exacerbations of chronic bronchitis with levofloxacin hydrochloride tablet as active control

Conditions: Acute Exacerbations of Chronic Bronchitis

Summary: the purpose of this study is to use oral prulifloxacin to treat patient with acute exacerbations of chronic bronchitis and compare the effect with levofloxacin.


Eligibility criteria:
inclusion criteria: 1. patient is willing to participate in the study and gives the signature of informed consent; 2. in and out-patients (aged 18-70 years old), male or female; 3. patient receives no effective antibacterial therapy or the therapy has no remarkable efficacy, or positive bacterial test result in the past 72 hours; 4. diagnosed as mild to moderate acute exacerbation of chronic bronchitis patients (see \ ) 5. within 48 hours prior to the study, women of child-bearing age have a negative urine pregnancy test and is willing to use efficient measures of contraception to avoid pregnancy during the study. exclusion criteria: 1. patient hypersensitive to quinolones or with allergic constitution; 2. patient with severe condition which need combination with other antibacterial agents; 3. concurrent infections in other organs or system; 4. patient with severe heart, liver or kidney disease, or q-t prolongation of over 450 ms, serum ast or alt more than twice as high as the upper limit of normal or cr over the upper limit of normal; 5. with any of the following diseases: active tuberculosis, bronchiectasis, lung abscess, aspiration pneumonia, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary addicted acidic granulocyte infiltration and pulmonary vasculitis syndrome; 6. patient with severe hematologic disease or central nervous system disease or convulsion history, with mental status unable to coordinate; 7. patient with malignant tumor or other severe background disease; 8. patient with severe immunodeficiency; 9. a history of tendon; 10. known pregnancy or lactation; 11. prulifloxacin contains lactose, therefore, patients with a rare genetic disease such as galactose intolerance, lapp lactase deficiency or glucose - galactose malabsorption cannot be enrolled; 12. participation in other clinical trials within 3 months before screening or currently on any investigational therapy.

Keywords: prulifloxacin aecb levofloxacin
noninvasive assessment of lymphedema among breast cancer survivors

Conditions: Lymphedema of Upper Arm; Breast Cancer

Summary: this proof of concept study will evaluate the ability of a new, ultrasound based technology called bullseye constructive shearwave interference (csi) (trade name, bullseye elasticity quantification) to measure lymphedema of the upper arm among breast cancer survivors. the study's hypothesis is that the csi device can detect the presence of clinically significant lymphedema when compared with the standard arm tape measurement.


Eligibility criteria:
inclusion criteria: * any subject with a history of unilateral breast cancer who has completed definitive treatment for breast cancer (i.e. previously undergone surgical resection, with or without adjuvant radiotherapy and/or chemotherapy). subjects must have completed all recommended adjuvant radiotherapy. subjects who continue on systemic therapy may be included at the discretion of the treating physician. * subjects with a history of unilateral axillary sentinel biopsy, lymphadenectomy or dissection are eligible for inclusion. * subjects taking hormonal therapy are eligible for inclusion * subject has any stage lymphedema exclusion criteria: * active rash or skin tears/injury in bilateral upper extremities * subjects with history of contralateral breast cancer treatment
diltiazem in jervell and lange-nielsen syndrome

Conditions: Jervell and Lange Nielsen Syndrome

Summary: this study will test the effect of diltiazem, a calcium channel blocking drug, on the qt interval in patients with jervell and lange-nielsen syndrome. this will be a single iv dose and acute effects (within minutes) will be observed.

subjects will be recruited by study personnel and will be scheduled for a single outpatient visit. if an implanted cardiac device (pacemaker or icd) is in place, it will be interrogated to ensure no recent rhythm abnormalities. just prior to administering diltiazem, an ecg and bp will be obtained. if baseline sbp is \ 100 mm hg) a repeat dose (0.35 mg/kg) will be given at 15 minutes, with 12-lead ecg and bp obtained at 17, 20, 22, 25, 30 and 35 minutes. after 20 minutes (single dose) or 35 minutes (2 doses), the test will end and the subject will remain on continuous telemetry for 2 hours. prior to discharge the iv will be removed. the primary analysis will be a repeated measures (paired) comparison of the qtc at baseline and following diltiazem.

Eligibility criteria:
inclusion criteria: * age greater than 18 years * genetically confirmed diagnosis of jervell and lange-nielsen syndrome * able to provide written informed consent exclusion criteria: * known hypersensitivity to diltiazem * pregnancy * congestive heart failure, angina, preexcitation, or chronic obstructive pulmonary disease * sick sinus syndrome or atrioventricular block in the absence of a pacemaker/defibrillator * any clinically significant ongoing medical or surgical condition that might jeopardize the subject's safety or interfere with the conduct of the study in the judgement of the investigator * baseline systolic blood pressure less than 100 hg or diastolic blood pressure less than 60 hg

Keywords: long qt syndrome