Kornimate/medical-research-clean huggingface dataset:
measurement of feno in young children with the niox vero

Conditions: Asthma

Summary: feno measurements provide the physician with means of evaluating an asthma patient's response to anti-inflammatory therapy, as an adjunct to the established clinical and laboratory assessments in asthma. interpretation of feno profiles is based on the nitric oxide plateau. to achieve plateau, the duration of exhalation must be sufficient (at least 4 seconds for children \ 6 seconds for children \> 12 years (ats/ers, 2005). measurement of feno using the 6-sec mode may provide a viable alternative in children as young as age 4 years who may have difficulty maintaining exhalation for a full 10 seconds.

the primary objective is to assess the degree of agreement of feno measured with the niox vero using the 6-sec and 10-sec modes. the secondary objectives of the clinical investigation are to: * assess the ability of participants to use the niox vero for measuring feno in both exhalation modes, and * compare the repeatability of feno measured with the niox vero in both exhalation modes. participants will attempt 2 measurements taken using the 6-sec mode followed by 2 measurements using the 10 second exhalation mode or vice versa.

Eligibility criteria:
inclusion criteria: 1. male or female 4, 5 and 6 years old, 2. primary language: english or spanish, and 3. healthy (e.g., no pulmonary disease) or asthmatic (if asthmatic, they must have a physician diagnosis of asthma). exclusion criteria: 1. pulmonary disease status: any disease other than asthma. 2. in the opinion of the investigator, has severe or uncontrolled asthma (defined as having a) 2 or more exacerbations within the last year that required the use of systemic corticosteroids, or b) 1 or more hospitalizations, icu stays or mechanical ventilations within the last year). 3. has taken their reliever inhaler within 4 - 6 hours from the feno measurements. 4. has acute asthma symptoms, respiratory illness (e.g. cold, flu), or sinusitis. 5. has had food or beverage intake (other than water) or has participated in strenuous exercise within 1 hour prior to feno measurement. 6. has a family relationship with the operator or study personnel (persons who are family members of the operator or study personnel are not eligible to participate). 7. has a parent/guardian who is unable or unwilling to provide informed consent.

Keywords: feno, exhaled nitric oxide
cardiovascular (cv) risk evaluation in type 2 diabetes subjects

Conditions: Type 2 Diabetes Mellitus; CV Risk

Summary: the primary objective of this study is to assess the total cv risk in patients with type 2 diabetes and also to assess the impact of rosiglitazone in the total cv risk and the parameters of metabolic syndrome.


Eligibility criteria:
inclusion criteria: * patients with diabetes type 2 that their physician has decided to prescribe avandia for better control of their condition * have signed informed consent exclusion criteria: * patients with alt \> 2.5x the normal value * with heart failure symptoms * with diagnosis of angina pectoris or stable angina demanding continuous treatment with nitrates * with recent myocardial infarction (\<6 months) * with severe renal disfunction * pregnant or lactating or planned to be pregnant during the study * under investigational drug treatment * alcoholic or drug abuser

Keywords: type 2 diabetes cv risk rosiglitazone avandia
study of transdermal fentanyl patch to treat postoperative pain in total knee arthroplasty

Conditions: Postoperative Pain

Summary: the purpose of this study is to determine whether transdermal fentanyl patch

total knee arthroplasty (tka) has severe postoperative pain that prevents mobilization of patient. the best standard analgesia regimen is patient-control analgesia (pca) which requires a pca pump that is expensive. transdermal fentanyl patch (tfp)(50 mcg/hr) can release fentanyl into blood circulation at rate 50 mcg/hr for three days. it has slow onset of about 12-14 hours, so it's used to treat chronic pain, not popular for a cure of pain. if the investigators apply tfp at appropriate times, i.e. 12-14 hours before surgery, it may be used to treat acute postoperative pain. if it can give good analgesia for tka, it can replace pca. the benefit is that it is much cheaper and more convenient.

Eligibility criteria:
inclusion criteria: * patients who were scheduled for tka gave informed consent for inclusion exclusion criteria: * asa class 3-4 * known allergy to any of the drugs to be used, eg. tfps ,mo * history of substance or alcohol abuse, and tolerance or dependence on opioids * can not use pca * contraindication for spinal anesthesia

Keywords: postoperative pain score morphine consumption
the leaflex™ brazilian standalone study

Conditions: Aortic Valve Stenosis

Summary: a prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the leaflex™ performer in the treatment of symptomatic severe aortic stenosis. subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.


Eligibility criteria:
inclusion criteria: * patient with symptomatic, severe aortic stenosis who are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement. * patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent. exclusion criteria: * severe aortic regurgitation. * anatomic contraindications. * coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease ≤ 1 month prior to index procedure. * aortic balloon valvuloplasty ≤ 3 months prior to index procedure. * stroke ≤ 12 months prior to index procedure. * history of a myocardial infarction ≤ 6 weeks prior to index procedure. * patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy. * hemodynamic instability. * hypertrophic cardiomyopathy with obstruction. * left ventricle ejection fraction \<30%. * ongoing severe infection, including endocarditis, or sepsis. * life expectancy ≤ 12 months.
registry and biorepository for ibd in central texas

Conditions: Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Summary: this is a prospective, non-interventional registry and biorepository for patients with ibd. longitudinal follow-up data is collected from both patients and their treating gastroenterologist during routine clinical encounters. the biorepository will consist of prospective collection of blood samples, tissue samples, and fecal samples for research purposes, while the participants are undergoing a clinically-indicated procedure (i.e. venipuncture for routine tests, iv catheter placement, and/or endoscopy). participants may choose to provide any or all of the aforementioned information and/or samples.


Eligibility criteria:
inclusion criteria: * male or female, age 18 years or older * willing and able to provide written consent for participation in the registry and biorepository * patients with known or suspected inflammatory bowel disease exclusion criteria: * patient is unable to comprehend and/or cooperate with study activities * patient is too ill to provide consent * coagulopathy that precludes safe biopsy of the bowel * comorbidity that precludes safe participation in endoscopic procedures
improving the detection of active tuberculosis in accident and emergency departments

Conditions: Latent Tuberculosis; Active Tuberculosis

Summary: tuberculosis (tb) control remains a public health challenge. many people in the uk do not have a general practitioner (gp) registration and their only interaction with the nhs is via accident and emergency (a\&e) departments of hospitals. this is often the case for those in hard to reach groups, who are also those often at highest risk of tb. this study seeks to assess whether a\&e departments are effective sites for the identification and onward management of tb, both in its latent and active forms.

this proposal is focused upon early diagnosis, referral and treatment of active tuberculosis, which has two key components: 1) ensuring optimal outcome for individuals; 2) contributing to disease control in public health terms by preventing further spread. a\&e departments are an important point of testing and referral for the client group that constitute those at greatest risk, as for many this will be their only interaction with the health service. currently, a\&e departments contribute about 20% of those diagnosed with tb. the majority of these individuals are most likely to have presented with symptoms indicative of disease, compared to those attending for other reasons who would have been unlikely to have been tested or referred. this study will seek to evaluate specific measures currently being undertaken by public health england and the nhs to control tb as well as investigate whether case finding for active tb in a\&e departments would improve tb control. the economic impact of these interventions will be evaluated, providing a measure of its value for money.

Eligibility criteria:
inclusion criteria: 1. individuals 16 years or older, who are new entrants from high incidence countries who have arrived in the uk within the past 2 years or those born in high incidence countries who entered the uk more than five years ago, but have spent more than one year (cumulative) in the past five years in a high incidence country. 2. those with social risk factors who have signs and/or symptoms of tb. exclusion criteria: 1. individuals who are under 16 years 2. individuals who were born in the uk or a low incidence countries and do not have risk factors

Keywords: tuberculosis accident and emergency
effect of visceral vs total body fat reduction in obese female with stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the aim of this study is to investigate the visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females.

compare the effect of visceral fat reduction versus total body fat reduction on stress urinary incontinence in obese females. control group: consist of 20 obese women. they will receive kegel exercises only 3 session/ week for 12 weeks. diet group: consist of 20 obese women. they will receive low caloric diet and kegel exercises 3 session/week for 12 weeks. ultrasound cavitation group: consist of 20 obese women. they will receive kegel exercises 3 session/week and ultrasound cavitation two sessions per week.

Eligibility criteria:
inclusion criteria: * they will be diagnosed with stress urinary incontinence grade≥ 1 * their age will range from 35-48 years old. * their body mass index will exceed 29.9 kg/m². * their hip waist ratio will be more than 0.85 cm. * they will be multipara \>1. exclusion criteria: * · fecal incontinence, urge incontinence, overflow incontinence or functional incontinence or prolapse. * diabetes, asthma, cardiovascular, or renal diseases * taking medication for stress urinary incontinence or hormonal replacement therapy. * gynecological surgeries, or surgeries for obesity. * pregnant women.

Keywords: visceral fat total body fat obese female stress urinary incontinence
assessment of treatment safety and quality of life in patients receiving etanercept biosimilar for autoimmune arthritis

Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Summary: in this open-label, multi-center, observational, post-marketing surveillance study, patients with ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly in real-world settings. safety and effectiveness of biosimilar etanercept were evaluated in study participants for a duration of up to 12 months.

in this open-label, multi-center, observational, post-marketing surveillance study, patients with ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly in real-world settings. safety and effectiveness of biosimilar etanercept were evaluated in study participants for a duration of up to 12 months. patient information was recorded in four notebooks, and each notebook had three sections, one section for each month. the first section of notebook i contained demographic information, pregnancy and lactation status in female patients, cigarette smoking and alcohol consumption, and past medical history. all safety and effectiveness outcomes were recorded at the appropriate sections of the notebooks.

Eligibility criteria:
inclusion criteria: * adults with the diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis receiving biosimilar etanercept (either 25 mg or 50 mg) for their medical condition. exclusion criteria: * no strict exclusion criteria were applied.

Keywords: etanercept biosimilar safety quality of life rheumatoid arthritis ankylosing spondylitis psoriatic arthritis
tai chi chih and varicella zoster immunity

Conditions: Varicella

Summary: a randomized control trial testing whether a relaxation response based intervention, tai chi chih, will affect varicella zoster virus (vzv) specific immunity measures of psychological adaptation and health function in the older adult.

both the incidence and severity of herpes zoster (hz) or "shingles" increase markedly with increasing age, is a painful condition, due to a decline in varicella zoster virus (vzv) specific immunity. considerable evidence further shows that psychological stresses salient in the older adult correlate with impairments of cellular immunity. the investigators have observed that varicella zoster immunity is always decreased in individuals with major depression. moreover, our preliminary data indicates that the presence of depressive symptoms in older adults is associated with a decline of vzv responder cell frequency (vzv-rcf). taken together, the untoward effects of age and depressive symptoms on vzv immunity raise the question as to whether an alternative medicine intervention might augment vzv specific immunity in the older adult. we have preliminarily shown that administration of a relaxation-response based intervention, tai chi chih (tcc), results in improvements in health functioning and vzv immunity in older adults as compared to controls. tcc is a slow moving meditation comprised of twenty separate standardized movements for use in elderly populations. this proposed controlled clinical trial aims to: 1) determine whether the practice of tcc for 16 weeks influences varicella zoster virus (vzv) immunity; 2) demonstrate that tcc can produce significant changes in psychological adaptation, health behaviors, and health functioning and well-being; and 3) assess whether changes in psychological adaptation, health behaviors, and health functioning correlate with changes in vzv immunity following tcc in older adults. we hypothesize that this behavioral intervention that prioritizes treatment of excessive physiological arousal can influence one's affective state with effects on cellular immunity. by standardization of training and practice schedules, tcc offers an important advantage over prior relaxation response based therapies. focus on older adults at increase risk for hz and assay of vzv specific cellular immunity has implications for understanding the impact of behavioral factors and an alternative medicine intervention on a clinically relevant endpoint and the ability of the immune system to respond to antigens of infectious pathogens.

Eligibility criteria:
history of varicella or long-term resident (greater than or equal to 30 years) in the continental united states.
sit-to-stand in spinal cord injury patient

Conditions: Injuries, Spinal Cord

Summary: 1. were there differences in functional ability between ambulatory individuals with sci who passed and failed the independent sit-to-stand (ists) task? 2. did the ability of ists relate to ability of walking as determined using a type of aad used? 3. what were factors associated with the ability of ists?

* to evaluate the proportion and compare functional abilities between subjects who passed and failed the independent sit-to-stand (ists) task. * to assess the relationship between ability of ists and types of aad used. * to investigate factors associated with the ability of ists.

Eligibility criteria:
inclusion criteria: * ambulatory patients with isci from both non-traumatic and traumatic causes * aged at least 18 years * who are able to walk independently with or without aads at least 15 meters continuously \[fim locomotor (fim-l) scores = 5 to 7\] exclusion criteria: * any patients with conditions that might affect ambulatory ability; such as brain function disorders, visual deficits, musculoskeletal pain (vas \> 5), deformity of the musculoskeletal system, unable to follow a command of the tests, unstable medical conditions.

Keywords: sit-to-stand walking devices
protein expression as a potential diagnostic biomarker of cervical dysplasia and/or cancer

Conditions: Precancerous Condition; Stage 0 Cervical Cancer

Summary: this diagnostic trial is studying the presence of a specific protein as a potential biomarker of cervical dysplasia and/or cancer. the presence of specific proteins may allow a doctor to determine whether a patient has cervical dysplasia and/or cancer.

objectives: i. evaluate the utility of mn protein, a novel tumor-associated antigen, as a potential diagnostic biomarker for cervical glandular and/or squamous neoplasia in patients with a cytologic diagnosis of atypical glandular cells of undetermined significance (agus). ii. measure the frequency and type of cervical pathology associated with the diagnosis of agus in these patients. iii. determine whether the presence of a high-risk type of human papilloma virus (hpv) in a thinprep cervical cell specimen predicts the presence of cervical glandular and/or squamous cell neoplasia in these patients. iv. determine the relationship between mn antigen expression and the presence of high-risk hpv in these patients. outline: this is a multicenter study. patients undergo a pap smear followed by a thinprep cervical cell specimen collection at the time of direct colposcopic examination. patients then undergo a cone biopsy of the cervix using loop electrosurgical excision procedure with an endocervical curettage, an excisional cone biopsy of the cervix with or without endocervical curettage, or a hysterectomy. patients who are perimenopausal or postmenopausal or have a negative cervical cone biopsy also undergo endometrial biopsy or curettage. the pap smear specimen is analyzed to determine mn antigen expression and the thinprep specimen is analyzed for the presence of high-risk human papilloma virus and to determine mn antigen and other marker (e.g., p16) expression. patients who do not undergo hysterectomy are followed every 6 months for 2 years. all other patients are followed at 4, 26, and 30 weeks.

Eligibility criteria:
inclusion criteria: * cytologically confirmed atypical glandular cells of undetermined significance (agus) * must be scheduled to undergo complete histologic examination of the cervix by cone biopsy using loop electrosurgical excision procedure with an endocervical curettage, excisional cone biopsy with or without endocervical curettage, or hysterectomy within 6 months of the initial cytologic diagnosis of agus * no history of endometrial hyperplasia * no history of cancer of the endometrium, vagina, or cervix * hiv negative * no pregnant patients who are at high risk for excessive bleeding or preterm labor if a cone biopsy is performed * no prior cytotoxic chemotherapy for vaginal and/or cervical cancer * no prior radiotherapy to the vagina or cervix * no concurrent radiotherapy to the vagina or cervix * no prior hysterectomy
spine patient outcomes registry for biomet/ebi (electro-biology, inc)

Conditions: Degenerative Disc Disease; Spinal Stenosis

Summary: the purpose of this patient registry is to prospectively collect data on patients who are having spinal surgery with ebi and interpore cross spine products.

a patient registry to prospectively collect data on patients who are having spinal surgery with ebi and interpore cross spine products.

Eligibility criteria:
inclusion criteria: n/a exclusion criteria: n/a

Keywords: herniated nucleus pulposus (hnp)
rh-endostatin combined with ccrt(50 gy) followed by durvalumab maintenance for the treatment of specific phase iii nsclc

Conditions: Lung Cancer

Summary: a study to assess the effects of durvalumab following rh-endostatin combined with reduced-dose ccrt(50 gy) in patients with stage iii unresectable non-small cell lung cancer who can not tolerate 60 gy irradiation.

a phase ii, single-arm, multi-centre study of durvalumab as sequential therapy in patients with locally advanced, unresectable non-small cell lung cancer (stage iii) who have not progressed following rh-endostatin combined with reduced-dose ccrt(50 gy) therapy (relief)

Eligibility criteria:
inclusion criteria: * age at 18-75 years. * documented evidence of nsclc (locally advanced, unresectable, stage iii) * measurable disease by response evaluation criteria in solid tumors (recist) * eastern cooperative oncology group performance status score (ecog ps) of 0 to 1. * estimated life expectancy of more than 12 weeks. exclusion criteria: * prior exposure to any anti-pd-1 or anti-pd-l1 antibody. * active or prior autoimmune disease or history of immunodeficiency. * evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis b, c and hiv. * evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris. * any unresolved toxicity ctcae \>grade 2 from the prior chemoradiation therapy. * active or prior documented inflammatory bowel disease (eg, crohn's disease, ulcerative colitis).
dose ranging trial for pixantrone in the fnd-r variant regimen in indolent non-hodgkin's lymphoma

Conditions: Lymphoma, Low-Grade; Lymphoma, Small Lymphocytic; Lymphoma, Mixed-Cell, Follicular; Lymphoma, Small Cleaved-Cell, Follicular

Summary: the aim of this trial is to determine the appropriate dose of pixantrone to be used in this combination and obtain data on the combination's safety and activity profile.

the fnd-r regimen is commonly used in the treatment of indolent non-hodgkin's lymphoma (nhl) and contains the chemotherapy agents mitoxantrone, fludarabine, dexamethasone (a steroid) and the monoclonal antibody rituximab. in this trial we are replacing mitoxantrone with pixantrone, an agent with a similar chemical structure (both agents are dna intercalators). the trial is being run in patients with relapsed or refractory indolent nhl and aims to define the appropriate dose of pixantrone to be used in this combination, as well as to obtain data on pixantrone's safety and activity profile in combination with these drugs. this trial is expected to recruit up to 30 patients in the usa. patients will be treated with the drug combination for up to eight months and then followed closely in the four-week period after the last administration. after that, patients will receive physician check-ups every three months.

Eligibility criteria:
inclusion criteria * patients with relapsed or refractory indolent (low-grade) nhl * who have received 1-3 prior treatments with chemotherapy exclusion criteria * patients previously treated with fludarabine * prior treatment with rituximab (rituxan), unless there was a complete response (cr) or partial response (pr) to that treatment * patients known to have an allergic reaction to rituximab, or to murine proteins.

Keywords: pixantrone bbr 2778 chemotherapy dna intercalator mitoxantrone fludarabine dexamethasone rituximab rituxan mabthera monoclonal antibody antibody nhl non-hodgkin's lymphoma indolent low grade novuspharma