Kornimate/medical-research-clean huggingface dataset:
nitric oxide (no) donors and inhibitors study: study to evaluate l-arginine and aminoguanidine in asthmatic subjects

Conditions: Asthma

Summary: the primary aim of this study is to investigate the effects of oral and inhaled administration of l-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled no and no metabolites in exhaled breath condensate, saliva and nasal lavage fluid in normal and asthmatic subjects.

nitric oxide (no) is produced by a variety of cells within the respiratory tract, particularly airway epithelial cells, and its increased concentration in asthma is likely to derive from inducible no synthase (inos) expressed in inflamed airways. to evaluate whether an increased bronchial flux of no (ie, airway wall no flux \[jno\] in picoliters per second) produced in the large airways is due to an enzyme overexpression, we administered a relatively selective inos inhibitor, aminoguanidine, by nebulization in a double-blind, placebo-controlled manner in asthmatic and healthy subjects and also investigated whether the same concentration of inhibitor has any effect on no produced in the peripheral lungs (ie, alveolar no concentration \[calv\] in parts per billion \[ppb\]) or on the diffusing capacity of no (dno) \[in picoliters per second-1 per ppb-1) in the airways. aminoguanidine administration resulted in a significant reduction in jno compared with administration of the saline solution control in eight healthy subjects and in eight patients with asthma but caused no significant changes in calv or in dno in either group.

Eligibility criteria:
inclusion criteria: healthy non-smokers (n=10): * nonatopic subjects (exhaled no greater than or equal to 10 ppb; flow 50 ml/s) * normal spirometry * able to comprehend and grant a written informed consent asthmatic subjects (n=15): * forced expiratory volume in one second (fev1) of no less than 70% of predicted (exhaled no greater than or equal to 15 ppb; flow 50 ml/s) * clinically stable (steroid-naïve or taking no \> 600 mcg/day of inhaled steroids) * able to comprehend and grant a written informed consent exclusion criteria: * currently smoking * any lung disease other than asthma which may interfere with the study * treatment within the last 4 weeks with oral steroids * respiratory infection within 4 weeks prior to entry into the trial * females who are pregnant or lactating * history of current or past drug or alcohol abuse

Keywords: asthma
epidemiology of breast arterial calcification

Conditions: Coronary Disease; Cardiovascular Diseases; Heart Diseases

Summary: to test the hypothesis that breast arterial calcification (bac) seen on mammograms can identify women with an increased risk of coronary artery disease (cad).

background: the study hypothesis is that breast arterial calcification (bac) seen on mammograms can identify women with an increased risk of coronary artery disease (cad). annual mammograms are now routinely obtained on nearly 70% of women over forty years of age. the nearly 40 million examinations performed every year could be used to evaluate for bac without any additional cost or change in current mammographic techniques. identification of women with bac has potential to substantially decrease the rate of heart attack and sudden death due to cad in asymptomatic women. before bac can be used in a clinical setting, the age-specific prevalence of bac needs to be fully defined using state of the art mammographic techniques. bac then needs to be compared with well understood cad risk factors and measures of coronary atherosclerosis. while this could be accomplished in a prospective study, the same goals can be attained using data already acquired in the epidemiology of coronary calcification (ecac) study. the study uses existing data on 612 non-high risk, non-referred women who are participants in the community-based ecac study funded by nih from 1991-2006. this database includes traditional and newer coronary artery disease (cad) risk factors and the results of electron beam computed tomography (ebct) examinations for cac at a baseline examination. most of the women also have had risk factors and cac measured during a follow-up examination, on average, five years after baseline examinations. the women in the ecac study, who do not have a history of myocardial infarction (mi) or stroke, represent the full age range routinely evaluated with mammograms. almost all these women have their usual care, including annual mammograms, in rochester, minnesota. design narrative: the ecac study has been instrumental in establishing the distribution of presence and quantity of cac as well as the predictors of cac. the database includes clinical and laboratory assessments of cad risk factors, results of ebcts, and findings on physical examinations. it will ultimately include information on adverse clinical events. there are 612 female participants who had one or more mammograms during the 12-year history of that study. many women had 10 or more mammograms. the study will evaluate all of these mammograms for bac and compare the findings with information already in the database. the combination of newly acquired data from mammograms with the existing data allows this to be a very comprehensive study and still be completed in the two-year time period. the findings can then be used to help design a future study to prospectively evaluate the impact of instituting preventive and early therapeutic measures for cad in asymptomatic women with the appropriate features of bac on mammography.

Eligibility criteria:
no eligibility criteria
the relationship between cerebral state and emotion in anesthesiologist and surgeon

Conditions: Burnout, Professional

Summary: this study was designed to observe the cerebral state obtained via wavelet analysis (hxd-i,beijing easymonitor technology co.ltd, china) and evaluate the emotion in various states in anesthesiologist and surgeon. and we also explore the association between the characteristic of cerebral state and the emotion.

a total of 20 anesthesiologist (a group) and 20 surgeon(s group) in ruijin hospital were enrolled for this study. except had a medical history of mental illness or emotional disorder and pregnant woman. a group and s group completed emotional self-perceived questionnaire and then observe the characteristic of cerebral state via cerebral state monitor. they also completed anonymous questionnaire, including maslach burnout inventory-general survey(mbi-gs), self-reporting inventory-90(sci-90), burnout measure(bm).

Eligibility criteria:
inclusion criteria: * a total of 20 anesthesiologist (a group) and 20 surgeon(s group) in ruijin hospital were enrolled for this study. exclusion criteria: * had a medical history of mental illness or emotional disorder and pregnant woman.

Keywords: anaesthetists, surgeons, stress, burnout
cd34 selection of the peripheral blood stem cell graft for autologous transplant

Conditions: Breast Cancer

Summary: evaluate the feasibility and safety of autologous transplantation of cd34+thy-1+ hematopoietic stem cells afer high dose marrow ablative chemotherapy in patients with breast cancer.

selection of cd34+thy-1 positive cells from peripheral blood cells procured for autologous hematopoietic support following high dose treatment with bcnu, cyclophosphamide \& cisplatin for stage iv breast cancer \& limited prior treatment

Eligibility criteria:
inclusion criteria:- stage iv breast cancer * primary breast cancer does not express cd34+ * adequate organ function * no evidence of active infection exclusion criteria:- chemotherapy within 4 weeks * cns disease
asdactive: an integrated theory-based intervention to promote habitual physical activity

Conditions: Physical Inactivity; Sedentary Behavior; Autism; Autism Spectrum Disorder; Asperger Syndrome; Behavioral

Summary: asdactive is a theory-based behaviour change intervention aimed at improving the physical activity behaviours of autistic youth. the feasibility of the intervention will be tested through interviews with participants and stakeholders. "proof of concept" will be tested through preliminary measures of physical activity measured before and after the intervention.

asdactive is has been developed with guidance from autistic people and stakeholders in autism. it is informed by motivation and behaviour change theory, specifically habit theory. the intervention aims to improve the habitual exercise behaviours of autistic youth by focusing on their strengths and interests. the feasibility study will run for 3-months, with a further 3-month follow-up period. participants will attend motivational sessions in person where they will self-select physical activity habits to incorporate into their daily lives. they will be taught fundamental movement skills that they can use in their own leisure time. in-person sessions will be held once per fortnight with online sessions twice weekly. participants will be encouraged to engage with as many sessions as possible, but part of the evaluation will assess uptake and engagement. self-determination theory and habit theory will underpin all aspects of the intervention and autistic strong interests will be embedded in the materials used.

Eligibility criteria:
inclusion criteria: * young people aged 10-24-years diagnosed with level 1 autism or asperger's syndrome exclusion criteria: * physical conditions or injuries that might hinder physical activity participation

Keywords: behavior change physical activity exercise autism aspergers feasibility implementation mapping
rural chronic disease risk reduction

Conditions: Chronic Disease; Risk Reduction

Summary: this study tests a web-based chronic disease risk reduction intervention among rural adults.

the impact of chronic diseases has important implications for public health presently and in the future. the prevalence of chronic diseases is expected to rise with subsequent increases in mortality, morbidity, and health care costs. this proposed pilot project involves testing an adapted evidence-based health promotion and disease risk reduction curriculum using a web-based delivery format and determine its impact and efficacy among rural participants. the project is expected to contribute to improved human health by promoting healthy behaviors that reduce the development, progression, and exacerbation of chronic diseases.

Eligibility criteria:
inclusion criteria: 1. be at least 18 years of age, 2. reside in a rural southern county (rucc 4-9), 3. speak, write, and understand english, 4. have access to a computer with internet service or smartphone with cellular data, 5. have the ability to access the zoom platform, and f) have at least one chronic disease risk factor or diagnosis (diabetes, prediabetes, overweight, smoker, hypertension, family history of cancer, diabetes, heart disease, elevated cholesterol level, overweight or obese, etc.). exclusion criteria: * not from a rural area * younger than 18

Keywords: chronic disease health promotion risk reduction
gardening activities for the elderly psychological well-being and depression

Conditions: Elderly Person

Summary: purpose of the study: this research will be conducted to determine the effects of gardening activities applied to the elderly in nursing homes on psychological well-being and depression. research hypotheses h0: gardening activities applied to the elderly in the nursing home do not affect the psychological well-being of the elderly. h1: gardening activities applied to the elderly in nursing homes increase the psychological well-being of the elderly. h0: gardening activities applied to the elderly in the nursing home do not affect the depression level of the elderly. h1: gardening activities applied to the elderly in nursing homes reduce the depression level of the elderly.

this study was planned as a single-blind randomized controlled experimental study.

Eligibility criteria:
inclusion criteria: * staying in a nursing home for at least 3 months, * does not have a physical disability that may hinder gardening activities, * no vision or hearing loss that may hinder gardening activities, * open to communication and cooperation, * the elderly who volunteer to participate in the study will be included in the study. exclusion criteria: * having a serious medical disability (such as paralysis, parkinson's), * having a serious psychiatric diagnosis, * severely demented and * the elderly who do not want to continue the research will be excluded from the research.
a study to evaluate the single vaccination of an adenovirus serotype 26 pre-fusion f (ad26.pref) based respiratory syncytial virus (rsv) vaccine in japanese adults aged 60 years and older

Conditions: Healthy

Summary: the main purpose of this study is to assess the safety and reactogenicity of the ad26.pref based rsv vaccine administered intramuscularly as a single injection versus placebo in japanese adults aged greater than equal to 60 years.


Eligibility criteria:
inclusion criteria: * participant must be a japanese participant whose parents and grandparents are japanese as determined by the participant's verbal report * before randomization, a woman must be: postmenopausal (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause); not intending to conceive by any methods * a male participant must agree not to donate sperm for the purpose of reproduction for a minimum 28 days after receiving the dose of study vaccine * in the investigator's clinical judgment, participant must be either in good or stable health. participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. if they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. participants will be included on the basis of physical examination, medical history, vital signs , and 12-lead electrocardiogram (ecg) performed at screening * from the time of vaccination through 3 months, participant agrees not to donate blood * participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study exclusion criteria: * participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, end stage renal disease with or without dialysis, clinically unstable cardiac disease, alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments * participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence) * participant has chronic active hepatitis b or hepatitis c infection, documented by hepatitis b surface antigen and hepatitis c antibody, respectively * participant has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures * participant has a history of chronic urticaria (recurrent hives), eczema and/or atopic dermatitis
biofilm correlation and validation

Conditions: Wound Infection

Summary: this is a prospective, single-blind, controlled trial. there are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (csb+/csb-) are allocated in each arm. the primary objective is to evaluate the diagnostic accuracy of moleculight fluorescence in identifying biofilm as validated by gold standard sem imaging.


Eligibility criteria:
inclusion criteria: 1. patients presenting with acute or chronic wounds 2. 18 years or older 3. willing to consent exclusion criteria: 1. treatment with an investigational drug within 1 month of enrolment 2. any contra-indication to regular wound care 3. inability or unwillingness to consent
phase 1 safety and pharmacokinetic study of ai-700 in patients with diminished dlco and copd and/or chf

Conditions: Congestive Heart Failure; Chronic Obstructive Pulmonary Disease

Summary: this study was conducted to evaluate the safety and pharmacokinetics of an echocardiographic contrast agent, ai-700, in patients with moderate to severe chronic obstructive pulmonary disease (copd) and/or congestive heart failure (chf).

in ongoing clinical trials, ai-700 is currently being evaluated for its value to provide enhanced echocardiography to detect cad. the patient population is comprised of those patients who have chest pain and are being evaluated for inducible ischemia. this population may include patients with compromised pulmonary function due to copd or chf. this study was to evaluate the safety of ai-700 in these patients.

Eligibility criteria:

Keywords: ultrasound contrast agent pharmacokinetics congestive heart failure chronic obstructive pulmonary disease safety
the effect of increasing the mean arterial pressure on the microcirculation and the prognosis of patients with septic shock

Conditions: Septic Shock

Summary: background： the mean arterial pressure（ map） is a key pressure index to improve tissue perfusion. at present, there are no surprising results of large-scale clinical studies on sublingual microcirculation. the changes of sublingual microcirculation were more severe in septic shock non-survivors than survivors. purpose： this study is mean to increase the map in septic shock patients whether with chronic hypertension or not, so as to observe the change of the microcirculation and prognosis. method： this is a single-center, randomized, prospective cohort study. eligible patients will be allocated into chronic hypertension or denying chronic hypertension group. these patients will be treat with vasopressors to maintain map at 90±5 mmhg and 70±5 mmhg. outcome： the 28-day all-cause mortality, the 90-day all-cause mortality, the 28-day without organ dysfunction days, the changes of sublingual microcirculation, sofa， apache-ⅱ score will be recorded.


Eligibility criteria:
adult patients (≥18 years) admitted to the critical medicine departments three of fujian provincial hospital will be considered eligible，who are presence of infection or suspected infection，requiring mechanical ventilation. at the same time, without the vasopressors the map would be less than 65mmhg, and the blood lactic acid level is higher than 2mmol/l.
a study of tasocitinib in dry eye subjects

Conditions: Keratoconjunctivitis Sicca

Summary: this is a phase 2 study to further evaluate the safety and efficacy of tasocitinib (cp-690,550) in the subjects with moderate to severe dry eye disease. both subjective and objective clinical endpoints will be measured for a duration of 12-week treatment.


Eligibility criteria:
inclusion criteria: * males and females aged 18 years or older at time of consent * diagnosis of dry eye disease, characterized by subjective symptoms of dry eye for at least 6 months, schirmer test without anesthesia: =\>1 mm and =\ 4 (nei scale), and subject grading total score of =\> 23 on the osdi exclusion criteria: * planned initiation of, or changes to, concomitant medication that could affect dry eye within 30 days of the screening visit or during study * ocular disorders that may confound interpretation of study results such as significant corneal surface disease not caused by dry eyes, abnormal corneal sensitivity, abnormal tear spreading, including but not limited to the following: abnormal lid function, lid position, or blink rate, that in the opinion of the investigator is clinically significant, history of herpetic keratopathy * lacrimal punctal occlusion (plugs or cautery) within 2 months of the screening visit * contact lens wear within 2 weeks of the screening visit and/or during study participation.

Keywords: dry eye schirmer test corneal staining osdi oci
study to evaluate the safety and efficacy of cj-30061 in hypertensive patients with hyperlipidemia

Conditions: Hypertension; Hyperlipidemia

Summary: to evaluate the safety and efficacy of cj-30061 compared with amlodipine/valsartan combination therapy and valsartan/atorvastatin combination therapy in hypertensive patients with hyperlipidemia


Eligibility criteria:
inclusion criteria: * aged between 19 and 74 years * diagnosed with essintial hypertension(average sisbp ≥ 140mmhg) accompanying hyperlipidemia(ldl-c ≥ 100mg/dl) and were on or off treatment at visit 1(screening) * decided to participate in the study and provided signed informed consent form voluntarily after receiving explanation of the objectives, methods, and effects of the study exclusion criteria: * severe hypertension defined as average sidbp ≥ 120mmhg or average sisbp ≥ 200mmhg at visit 1(screening) * the difference in bps between those measured at the reference arm at visit 1(screening) was ≥ 10mmhg for sidbp or ≥ 20mmhg for sisbp * ldl-c \> 250mg/dl or tg ≥ 400mg/dl at visit 1(screening) * secondary hypertension * diagnosis of type 1 diabetes mellitus(dm) or uncontrolled dm(patients on insulin therapy or patients with hba1c ≥ 9%)
safety and efficacy of fibrin sealant grifols (fs grifols) during parenchymous tissue open surgeries

Conditions: Parenchymous Tissue Surgical Bleeding

Summary: this study is designed to assess the safety and efficacy of fibrin sealant grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). the purpose of this study is to demonstrate that fibrin sealant grifols is not inferior to commercially-available oxidized cellulose pads (surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). this study has a preliminary part (i) for study teams to become familiar with the application of fibrin sealant grifols and to assess safety and a primary part (ii) to assess the safety and efficacy of fibrin sealant grifols. in both parts of the study, patients will be randomized in a 1:1 ratio to either fibrin sealant grifols or surgicel.


Eligibility criteria:
inclusion criteria: * hemoglobin (hgb) ≥ 8.0 g/dl at baseline (within 24 hours prior to surgical procedure). * require elective (non-emergency), open (non-laparoscopic), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume). * a target bleeding site can be identified. * target bleeding site is identified on the cut raw liver surface (resection area). * target bleeding site has moderate bleeding according to the investigator's judgment. exclusion criteria: * require hepatic resection due to trauma. * infection in the anatomic surgical area. * history of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product. * previous known sensitivity to any fibrin sealant grifols component or any surgicel® component. * females who are pregnant or nursing a child at baseline (within 24 hours prior to surgical procedure). * receiving an organ transplant during the same surgical procedure. * undergone a therapeutic surgical procedure within 30 days from the screening visit. * a target bleeding site cannot be identified. * the target bleeding site has a mild or severe bleeding. * occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure. * application of any topical haemostatic material on the resection surface of the liver prior to application of study treatment.

Keywords: fibrin sealant parenchymous tissue open surgery hepatic resection oxidized cellulose pads