Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety study of rthrombin in surgical hemostasis

Conditions: Blood Loss, Surgical

Summary: the objective of this study is to assess the immunogenicity and safety of recombinant thrombin (rthrombin) in patients with prior rthrombin exposure.

the safety, immunogenicity, and efficacy of rthrombin have been evaluated in phase 2 and phase 3 studies in the following surgical indications: spinal surgery, major hepatic resection, peripheral arterial bypass (pab) surgery, arteriovenous (av) graft formation for hemodialysis access, and skin graft surgery following burn injury. limited data on rthrombin reexposure currently exist. this study will assess the immunogenicity and safety of rthrombin in participants who are undergoing a surgical procedure during which topical rthrombin application is planned and who previously received rthrombin in phase 3 clinical trials or during prior spine, av graft formation, or pab surgical procedures.

Eligibility criteria:
inclusion criteria: * previous enrollment in a zymogenetics-sponsored phase 3 study and the recipient of treatment with rthrombin in that study or the recipient of commercially-available rthrombin in a prior spine, arteriovenous graft formation, or peripheral artery bypass surgical procedure * age of 18 years or older at time of consent * bleeding indicating treatment with rthrombin during the course of the surgical procedure * signed informed consent document approved by an institutional review board or independent ethics committee exclusion criteria: * currently undergoing a procedure requiring cardiopulmonary bypass or involving the aortic arch * known hypersensitivity to rthrombin product or any of its components * currently undergoing a surgical procedure where the use of other thrombin-containing hemostatic agents is planned * medical, social, or psychosocial factors that, in the opinion of the investigator, could affect the participant's safety or compliance with study procedures * treatment with any experimental agent within 30 days of study enrollment or treatment
use of eye tracking to aid in autism risk detection

Conditions: Autism

Summary: the study will use a non-invasive remote eye-tracking system (eyelink portable duo) to acquire a short series of eye-tracking measures.

the study will use a non-invasive remote eye-tracking system (eyelink portable duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children ages 12-48 months. we will recruit children from riley hospital for children at indiana university health clinics to determine whether these measures may help determine autism risk.

Eligibility criteria:
inclusion criteria: * young children ages 12-48 months scheduled for health care visits at riley hospital for children at indiana university health clinics (e.g., pediatric care center clinics). * children must have english- or spanish-speaking caregivers. * children must have a legal guardian that is able to provide consent. exclusion criteria: * child is younger than 12 months or older than 48 months. * child's caregiver(s) is not english- or spanish-speaking.
phenotyping of postural orthostatic tachycardia syndrome (pots)

Conditions: Postural Orthostatic Tachycardia Syndrome

Summary: this is an observational study to deeply phenotype the disorder of pots using multiple testing modalities.

this comprehensive multimodality deep phenotyping will improve the diagnostic approach, inform the development of new treatments, and allow the targeting of therapies to specific pots patients. the investigators will further identify the diagnostic tools, biomarkers, and clinical outcome measures most relevant to defining the disorder in clinical practice. the specific aim is to (1) define clinical pots classifications from multimodal clinical and laboratory data, (2) address exercise tolerance in pots using metabolomic assessments, (3) evaluate novel pots-specific patient outcome measures and (4) evaluate one year outcome data for pots specific research tests will include blood work (for immunophenotyping and neurohormonal assessments), autonomic function testing, skin biopsy (to evaluate intraepidermal nerve fiber density), co (carbon monoxide) rebreathing (for quantitative measurement of plasma volume and red blood cell mass), patient surveys (to characterize symptom profile and disease impact). blood biosamples will be stored as a repository for future research questions.

Eligibility criteria:
inclusion criteria: pots patients * age ≥ 14 years, able to provide informed consent (assent with parental consent for age \< 18) and comply with procedures * meets consensus criteria for pots: (1) sustained increase in heart rate ≥ 30 bpm above supine baseline within 10 min of quiet standing or upright tilt (≥ 40 bpm in individuals 12 to 19 years of age) or sustained upright hr (heart rate) \>120 bpm, (2) absence of orthostatic hypotension, (3) symptoms with standing that improve with sitting or lying down, (4) resting supine heart rate \< 100 bpm, (5) orthostatic symptoms present for at least 6 months * stable oral medication regimen for at least 14 days non-pots control patients * healthy women, age 18 - 30 years, able to provide informed consent and comply with study procedures * does not meet consensus criteria for postural tachycardia syndrome * no symptoms of orthostatic intolerance or dysautonomia. no history of other major medical disorder * resting supine heart rate \< 100 bpm exclusion criteria: none of the following exclusion criteria: * use of amphetamine-type stimulants, diuretics, selective norepinephrine reuptake inhibitor, anticholinergic medications (including tricyclic antidepressant medications), fludrocortisone, desmopressin in past 14 days * use of other autonomic drugs (adrenergic agents, pyridostigmine, droxidopa, triptans, ivabradine) in past 48 hours * currently receiving ivig (intravenous immunoglobulin), subcutaneous igg (immunoglobulin g), or any investigational medication (in past year) * infusion of iv fluids in past 7 days * history or evidence of another condition explaining symptoms or orthostatic tachycardia (e.g. structural heart disease, csf (cerebrospinal fluid) hypovolemia, or severe traumatic brain injury)
effect of peppermint water on breast crack

Conditions: Breast Diseases

Summary: to evaluate the effectiveness of a topical preparation of peppermint water in comparison with that of expressed breast milk for the prevention of nipple cracks in primiparous breastfeeding women.

one hundred and ninety-six primipara participants, who are breastfeeding after delivery at 38 or more week gestation, were assigned randomly to 2 groups, with one of 2 regimens (peppermint water, an old household remedy, and no treatment only using breast milk) to right and left sides. each group was followed for a maximum of 3 visits within 14 days and until the 6 weeks postpartum by telephone call. the aerial parts of mentha piperita were purchased from hakim momen tabrizi company, and the identity was confirmed by morphological characterization in comparison with the herbarium specimen retained in the school of pharmacy, tabriz university of medical sciences. also, a voucher specimen has been generated in that herbarium.

Eligibility criteria:
inclusion criteria: * new mothers with healthy term infants (38 weeks gestation or more) are eligible for recruitment into the study. the sample of breastfeeding mothers were collected in two cohorts according delivery type. each group consisted of 98 primipara mothers. exclusion criteria: * mothers who didn't plan to use peppermint water * discharged before an interview or had preterm delivery * postpartum fever * breast infection * nipple abnormalities * age less than 18 years * twins * taking medications at night * mothers who didn't have telephone line, and who were illiterate. * infants who used bottle-feeding or pacifier, or who had mouth infection, or an abnormal short frenulum.

Keywords: peppermint water nipple crack lactating women
cardiac amyloidosis prevalence of in older subjects affected by heart failure

Conditions: Cardiac Amyloidosis

Summary: tne aim purpose of this observational, multicentre and propective study is to determine the prevalence of cardiac amyloidosis in geriatric patients aged 80 years and older hospitalized within the last 12 months for heart failure with left ventricular hypertrophy (septum ≥ 12 mm) on echocardiography

patients recruitment will be curry out in 31 geriatric or cardiologic centres. patients will be recruited for 24 months. each patient will participate in the study for 12 months (baseline visit, follow-up phone calls every 3 months up to 12 months i.e., at 3, 6, 9 and 12 months). the following data will be collected at teh baseline visit: medical history, demography, clinical data, frailty status assessed by fried, triage risk screening tool (trst), triggers for cardiac decompensation, biological examination, genetic testing, echocardiographic data and other data. bone scanning with 99mtc-dpd or 99mtc-hmdp (early or late time with spect will be done during hospitalization or after discharge depending on availability at the imaging centre. the results of each examination will be evaluated to establish the existence and degree of fixation in the myocardium and to determine its distribution. follow-up phone s will be conducted every 3 months up to 12 months to collect hospitalizations for heart failure, hospitalizations for other cardio-vascular events, hospitalizations for non-cardiac events, admission to nursing homes or long-term care (ltc) facilities and death

Eligibility criteria:
inclusion criteria: * aged ≥ 80 years * hospitalised for decompensation of heart failure in the last 12 months * subjects with hypertrophy of the septum or left ventricle at cardiac echography (defined as ≥ 12 mm) * subjects able to undergo a bone scintigraphy scan * subjects willing to participate exclusion criteria: * subjects refusing to participate * subjects admitted to palliative care unit. * subjects under guardianship * subjects with a definite diagnosis of cardiac amyloidosis

Keywords: cardiac amyloidosis heart failure with left ventricular hypertrophy positive bone scintigraphy
a phase i study of bms-690514 in patients with advanced or metastatic solid tumors

Conditions: Cancer; Tumor

Summary: the purpose of this research study is to determine the highest dose of the drug (bms-690514) that can be safely given to patients with advanced cancer.


Eligibility criteria:
inclusion criteria: * men and women 18 and older * diagnosis of any solid tumor * ecog performance status score 0-1 * prior chemo-therapy, immunotherapy or radiotherapy with at least 4 weeks since the last treatment * treatment with vegfr2 or her1 tki allowed but not both (for instance avastin or tarceva, but not both) exclusion criteria: * treatment with other tkis within the past 4 weeks * patients with brain metastasis * patients with centrally located squamous cell carcinoma of the lung * major gastrointestinal surgery which may affect absorption of the drug * any surgery within last 4 weeks * history of thromboembolism * severe unmanageable diarrhea * subjects in part b will have non-small cell lung cancer (nsclc) * part b/cohort i erlotinib-naive subjects * part b/cohort ii subjects who have experienced disease progression while receiving erlotinib (erlotinib-resistant subjects)

Keywords: solid tumors
recognizing and preventing burnout

Conditions: Burnout, Professionals

Summary: the purpose of this study is to prevent burnout and offer the hospital staff a space for processing the emotional experiences.


Eligibility criteria:
inclusion criteria: * doctors, physiotherapists, nurses and care workers * be a professional worker at the rehabilitation respiratory unit * age \> 18 years old exclusion criteria: * refusal at the informed consent

Keywords: burnout health care workers coping skills clinical trial
pelvic external combined with 252-cf neutron intracavitary radiotherapy with or without platinum in treating advanced cervical cancer

Conditions: Cervical Cancer; Complications

Summary: the objective of this study was to evaluate the efficacy and complication of the treatment of pelvic external combined with 252-cf neutron intracavitary radiotherapy with or without platinum in local advanced cervical cancer patients in the short and long term.


Eligibility criteria:
inclusion criteria: * 1. to be aged from 18 (including 18) to 65 (including 65), female patient; * 2. expected survival ≥6 months * 3. pathologically proven diagnosis of squamous carcinoma or adenocarcinoma of the cervix, according to figo(international federation of gynecology and obstetrics) staging, appropriate stage for protocol entry, including iia2, iib,iiia,iiib; * 4. no patients with distant metastases; * 5. measurable target lesions (satisfying the criteria in recist 1.1); * 6. ecog ps status of 0-2; * 7. no prior treatment; * 8. no * 9. no surgery * 10. major organ function has to meet the following criteria: 1. bilirubin \<1.5 times the upper limit of normal (uln) 2. alt , ast and apl≤2.5 × uln 3. neut≥2.0 × 10\^9 / l 4. plt ≥ 100 × 10\^9 / l 5. hb≥60g/l 6. serum cr and urea nitrogen ≤ 1.5 × uln * 11. favorable cardiac functions, no patients with myocardial infarction within half a year, hypertension and coronary disease are well-controlled. exclusion criteria: * 1. serious heart disease, pulmonary disease, hepatic disease, , renal disease and metabolic disease, or with electrolyte disturbance; * 2. allergic to platinum; * 3. rejecte to join the study in other conditions.
effect of high intensity training on motor and cognitive functions

Conditions: Multiple Sclerosis

Summary: fatigability is one of the most prevalent disorder in ms followed by walking, balance and cognitive disorders. however, there are few experimental studies on the effects of fatigability on balance and gait hampering the knowledge of causal fatigue-related changes of walking, balance and cognition. nowadays, instrumented systems such as wearable devices and optoelectronic systems are available and can be used to provide quantitative and objective indexes useful to monitor the changes of gait parameters during a fatiguing performance. (moreover), instrumented assessment of patients' performances in dual task paradigms can reveal the possible impact of fatigability on cognitive functions. so far, high intensity functional training has been already used in ms to reduce fatigability. however, the true impact of reduced fatigability on walking, balance and cognition has not been assessed after a fatiguing task making impossible to understand the real impact of treatments focusing on fatigability on these functions. thus, the aims of the present proposal are to assess the: 1) the acute effect of experimentally induced motor fatigability on walking, balance and cognitive functions using an objective instrumented assessment before, during, and after an overground fatiguing walking test. 2) to investigate the effect of high intensity multimodal functional training to improve motor and cognitive disorders.


Eligibility criteria:
inclusion criteria: * more than 18 years of age * clinical diagnosis of multiple sclerosis (ms) * stable disease course without worsening more than 1 edss point over the last 3 months, -edss between 1.5 and 6 points * must be able to maintain upright posture without any assistance for 30 seconds * must be able to release a written informed consent. exclusion criteria: * ms relapse within the previous three months; * unable to comprehend the aims of the study and to follow test instructions; * diagnosis of major depression (dsm-5); * severe joint and/or bone disorders interfering with balance and gait (based upon clinical judgment); * cardiovascular diseases; * unconfirmed or uncertain diagnosis of ms (mcdonald criteria) * other concomitant neurological disease; * patients already performing aerobic or walking exercise.

Keywords: fatigue balance
chinese observational prospective study of aging population with chronic kidney disease(c-option)

Conditions: Chronic Kidney Disease

Summary: the study is an observational, multicenter, prospective cohort study aimed at evaluating a 5-year screening programme for chronic kidney disease(ckd) in a population of elderly patients, aged 65 years or more, in china.to analyze the etiology and composition spectrum, the incidence of complications and co-morbidities.to assess the correlation between daily living ability, mental and physical function, quality of life, nutritional status and prognosis.to develop biomarkers of renal aging.


Eligibility criteria:
inclusion criteria: * age≥65 years * clinical diagnosis of ckd * signed informed consent exclusion criteria: * subjects who have a poor compliance and cannot be scheduled for follow-up * subjects participating in other interventional clinical trials * esrd or dialysis * acute kidney injury(aki) * history of solid organ or bone marrow transplantation * active malignancy within 24 months prior to screening or metastatic cancer * life expectancy less than 6 months； * severe cognitive impairment（nyha iii or iv） * hiv infection or aids * subjects cannot be able to complete the assessment including dementia or other mental disorders, limited physical activity, severe visual impairment * simple hematuria
detection of plaque inflammation by positron emission tomography (pet)-effects of simvastatin on plaque inflammation

Conditions: Atherosclerosis

Summary: the purpose of this study is to determine whether fdg-pet is capable of detecting atherosclerotic plaque inflammation and monitoring the effects of statins on plaque inflammation. the usefulness of fdg-pet in risk stratification is also investigated.

there is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. however, currently, no non-invasive method is available for detecting plaque inflammation in clinical practice. fdg-pet can visualize activated metabolic levels of not only tumor cells but also inflammatory cells. thus, it is possible that fdg-pet can detect atherosclerotic plaque inflammation and that, if so, fdg-pet can monitor the direct effect of statins on plaque inflammation. additionally, monitoring the plaque inflammation by fdg-pet may be useful for determining the risk stratification of atherosclerotic patients. originally, we sought to compare patients with fdg-positive plaque with patients with plaque but not with fdg uptake, patients with fdg-positive plaque receiving statin therapy, and patients with fdg-positive plaque receiving diet management therapy. however, because patient number enrolled in the study was too small, the comparison was performed between fdg-positive patients with and without any statin therapy.

Eligibility criteria:
inclusion criteria: * protocol 1: patients who had carotid atherosclerosis detected by carotid ultrasound. * protocol 2: patients who underwent fdg-pet for cancer screening and had vascular fdg uptakes exclusion criteria: * active inflammatory diseases * dyslipidemia under medications * uncontrolled diabetes mellitus, vasculitis, symptomatic coronary artery disease, symptomatic cerebrovascular diseases * known systemic disorders such as hepatic, renal, hematopoietic, and malignant diseases

Keywords: atherosclerosis inflammation statins pet carotid ultrasonography
work-related musculoskeletal disorders questionnaire

Conditions: Musculoskeletal Diseases; Work-Related Condition

Summary: development and validation of a multi-factor and self-perceived risk assessment questionnaire, specifically referred to wmsds-related pain and risk factors

the world health organization (who) has defined a wmsd as one musculoskeletal disorder (msd) that results from a number of factors, and where the work environment and the performance of the work contribute significantly, but in varying magnitude, to the causation of the disease. the term msd denotes health problems of the musculoskeletal system, i.e. muscles, tendons, the skeleton, cartilage, the vascular system, ligaments and nerves; ranging from light and transitory disorders to disabling injuries and permanent disability, with the loss of employment. wmsds are in general not caused by one specific, but by multiple risk factors. these include physical (e.g. manual handling of loads, working in awkward postures, repetitive work and working at high speed, exposure to vibrations) as well as psychosocial (work stress, pain believes, sleep disturbances) factors. consequently, a holistic preventive approach is currently needed. in order to tackle wmsds, three different levels of prevention can be used to categorise these strategies: i) primary prevention includes the risk assessment process and technical/ergonomic, organisational and person-oriented interventions; ii) secondary prevention involves the identification and health monitoring of workers at risk; and iii) tertiary prevention comprises return-to-work actions. the answer to the wmsds problems in companies is holistic prevention, taking into account multifactorial risks for every individual, in order to propose a tailored educational program to every worker need the study aims to develop and validate a multi-factor and self-perceived risk assessment questionnaire, specifically referred to wmsds-related pain and risk factors gathering information and collecting data on the target population and wmsds related risk factors: * basic characteristics of the target populations (e.g. age, sex, work conditions etc.) * potential work-related risk factors (e.g. repetitive motion, static posture, etc.) * which of wmsds affect more the target populations (e.g. back pain, neck pain, upper limb pain, etc.) * potential effects of these and related domains (quality of life, pain, number of days of absence from work etc.)

Eligibility criteria:
inclusion criteria: * understanding of the italian language * worker of the irccs istituto ortopedico galeazzi exclusion criteria: - previous surgery for musculoskeletal disorders

Keywords: work-related musculoskeletal pain pain management prevention screening
improving adherence in adolescents and young adults with bipolar disorder

Conditions: Bipolar Disorder

Summary: although poor medication adherence occurs in more than 65% of adolescent and young adults (aya) with bipolar disorder (bd) and is associated with poor recovery, high rates of relapse, and a 5.2 fold increased suicide risk, there have been no interventions that specifically target adherence in aya with bd. this proposal will modify and test a customized adherence enhancement (cae) intervention developed by the investigative team and found to be effective in bd adults in a high-risk, high-need group: ayas with bd who are poorly adherent with prescribed bd medications. the project addresses the critical need for evidence-based interventions to improve adherence in ayas with bd and has the potential to change outcome trajectories in high-risk young people with bd as they transition to adulthood.


Eligibility criteria:
inclusion criteria: * dsm-5 diagnosis of bipolar disorder (bd), type i or ii as diagnosed by the structured clinical interview for dsm-5 (scid-5) * poor adherence defined as missing ≥ 20% of prescribed evidence-based bd medications, i.e., mood stabilizer (e.g., lithium, valproic acid, or carbamazepine) or second generation antipsychotics, on the trq for the past week or past month * if \ 18 years, able and willing to provide written informed consent * fluent in english exclusion criteria: * unable to receive care in the outpatient setting due to illness severity * a dsm-5 diagnosis of an autism spectrum disorder or primary psychotic disorder * documented or suspected iq \< 70 * prior enrollment in cae or phase 2 * have recently (in the past month) started a new psychotherapy/behavioral intervention