Kornimate/medical-research-clean huggingface dataset:
a study of observation and follow-up in people with basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: the purpose of this study is to find out more about how basal cell carcimonas/bccs grow and to learn more effective ways to monitor and treat these common cancers. this study will not provide any type of treatment for the participants' cancer; it is a 3-year observational study to monitor participants' cancer.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * diagnosed with at least 1 bcc based on clinical, dermoscopy, rcm and oct * patients with bccs that have a diameter smaller or equal to 1.5cm, allowing for 0.5cm growth before reaching the cutoff for stage 2 bcc, which would require removal of the bcc. * patients with bccs that have a depth smaller or equal to 0.6mm, to allow for tumor growth of 0.2mm before reaching the depth limitation of oct imaging (0.8mm) * treatment naiive lesions * ability to sign informed consent exclusion criteria: * immunosuppressed patients, such as those with a primary immunodeficiency caused by a genetic abnormality and a secondary immunodeficiency caused by aids, cancer, chemotherapy and other immunomodulating drugs, solid organ transplant recipitents, cll, aspelenia, and pregnancy). * patients with cancer genetic syndromes that increase risk of bcc (such as basal cell nevus syndrome, xeroderma pigmentosum, epidermolysis bulosa, oculocutaneous albinism, bazex-dupre-christol syndrome, rothmund-thomson syndrome, and epidermodysplasia verruciformis). * patients with bccs that are clinically suspected as high risk histopathologic subtypes, i.e. indented or sclerotic lesions that are suspected as morpheaform or infiltrative bccs. * patients with bccs that have a diameter larger than 1.5cm\\ * patients with bccs that have a depth greater than 0.6mm * patients with bccs in high risk locations, i.e. "h" area of the face. (is located in the mid-face at the site of the embryologic fusion plates and is generally believed to be associated with more aggressive skin cancers). * patients with bccs on locations that may compromise an organ function should the tumor enlarge (for example, eyelid). * tumor located on a site that precludes attachment of the rcm device or inability to tolerate imaging procedure (i.e. remain relatively still for multiple short durations of 3- 4 minutes over a total time of 20-30 minutes) * lesions that previously received therapeutic intervention * inability to give informed consent

Keywords: basal cell carcinoma memorial sloan kettering cancer center 21-007
registry to improve the adoption of consensus treatment guidelines (improve brady)

Conditions: Sinus Node Dysfunction

Summary: registry to improve the adoption of consensus treatment guidelines (improve brady)

the study is expected to provide evidence to support claim(s) that: * education and process improvement initiatives can improve the diagnosis of and appropriate therapy application for sinus node dysfunction (snd) * the quality improvement methods studied have general applicability and can be used by all centers * appropriate treatment minimizes caregiver burden * appropriate treatment improves quality of life (qol) and functional status compared to pre-implant

Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age * patient's heart rate meets at least one of the following: * patient has a sinus rate ≤ 50 or a junctional escape rhythm no faster than 50 * patient has a history of exercise intolerance * patient complains of general fatigue, shortness of breath, shortness of breath with exertion, syncope, light headed dizziness, palpitations, lethargy, dyspnea or malaise within the last 30 days that are not related to other discovered causes (such as untreated hypothyroidism or anemia). * patient (or patient's legally authorized representative) is willing and able to sign and date written patient consent form/patient data release consent exclusion criteria: * patient has type ii 2nd degree av block, high degree av block (2:1, 3:1, 4:1 etc.) or 3rd degree av block * patient has recent history of blood loss * patient has a medical history leading to suspicion of neurological disorder * patient has a history of chronic atrial fibrillation * patient is enrolled or planning to participate in a concurrent drug and/or device study at any time during the course of this clinical study without documented pre-approval from the medtronic study manager * patient is not expected to survive for 12 months * patient is anticipated to be unwilling or unable to comply with the clinical investigation plan

Keywords: sick sinus syndrome bradycardia
be study budesonide 80 μg and formoterol fumarate dihydrate 4.5 μg inhalation product in asthma patient

Conditions: Asthma

Summary: the purpose of the study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in adult patient with asthma

this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of fev1 measures at different timepoints in adult patient with asthma.

Eligibility criteria:
inclusion criteria: * male or female patients who are 18-70 years of age * has moderate-to-severe asthma with a pre-bronchodilator fev1 of ≥45% and \<80% of the predicted normal value for the patient after withholding bronchodilators * has ≥15% and ≥0.20 l reversibility of fev1 within 30 minutes following administration of 360 μg of albuterol (pmdi) * is stable on current chronic asthma treatment (documented asthma diagnosis and/or prescription for asthma medications) for at least 4 weeks prior to screening visit (visit 1). * has been diagnosed with asthma as defined by the national asthma education and prevention program (naepp 2007) at least 6 months prior to screening * adult male or female patients of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control exclusion criteria: * has history of life-threatening asthma defined as an asthma episode(s) that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s), within past 1 year or during run-in period * has history of any asthma-related hospitalizations within the past one year prior to screening visit (visit 1) or during the run-in period * has history of any pulmonary disorder other than asthma, including but not limited to: diagnosis of chronic obstructive pulmonary disease (copd), interstitial lung disease, cystic fibrosis, bronchiectasis, chronic bronchitis, pulmonary hypertension, active pulmonary tuberculosis, or pulmonary carcinoma. * has current evidence of bronchopulmonary dysplasia or pulmonary fibrosis * has recent respiratory tract infection that is not resolved within 4 weeks of screening and is considered significant in the opinion of the investigator * patients who, in the opinion of the investigator, significantly abuse alcohol or drugs, will be excluded. * is taking any immunosuppressive medications within 4 weeks prior to the screening and during the study * use of systemic or oral corticosteroids within 2 months or intramuscular depot corticosteroid treatment 90 days prior to the screening or during the run-in period for any reason other than asthma. * women of childbearing potential who are lactating or pregnant at screening visit, as documented by a positive screening pregnancy test. * has previously been randomized in this study
study of bay43-9006 in patients with unresectable and/or metastatic renal cell cancer

Conditions: Carcinoma, Renal Cell

Summary: the purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of bay43-9006 when added to best supportive care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

overall survival (os), patient-reported outcome (pro)

Eligibility criteria:
inclusion criteria: * patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented * patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization * patients who have at least one uni-dimensional measurable lesion by ct-scan or mri according to response evaluation criteria in solid tumors (recist) * patients who have an eastern co-operative oncology group (ecog) performance status of 0 or 1 * patients who have adequate coagulation, liver and kidney functions exclusion criteria: * patients with rare subtypes of renal cell carcinoma (rcc) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors * previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated \> 2 years prior to entry * cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure * patients with a history of human immunodeficiency virus (hiv) infection or chronic hepatitis b or c * patients with a history or presence of metastatic brain or meningeal tumors * patients with seizure disorder requiring medication (such as anti-epileptics) * history of organ allograft or bone marrow transplant of stem cell rescue * patients who are pregnant or breast-feeding women of childbearing potential must have a negative pregnancy test prior to drug administration. both men and women enrolled in this trial must use adequate birth control * patients who have three or more of the following: * ecog performance status greater than or equal to 2, * abnormally high lactate dehydrogenase, * abnormally high serum hemoglobin, * abnormally high corrected serum calcium, * absence of prior nephrectomy * excluded therapies and medications, previous and concomitant: * concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates * significant surgery with 4 weeks of start of study * investigational drug therapy during or within 30 days * concomitant treatment with rifampin or st. john's wort * prior use of raf-kinase inhibitors (rki), mek or farnesyl transferase inhibitors * prior use of bevacizumab, and all other drugs (investigational or licensed) that target vegf/vegf receptors

Keywords: renal cell cancer (rcc) cancer
measuring the influence of kefir on children's stools on antibiotics (milk)

Conditions: Respiratory Tract Infections

Summary: the purpose of this study is to determine the effectiveness of commercially available kefir on preventing antibiotic-associated diarrhea compared to placebo in children ages 1-5.

diarrhea is a common and costly disease of children in the united states. children less than 5 years of age experience 20-35 million episodes of diarrhea per year. these episodes lead to 2-3.5 million physician visits (which account for 10% of all visits), more than 200,000 hospitalizations (13% of hospital admissions in children less than 5 years), and 325-425 deaths annually. in 1991, the outpatient costs of treating diarrhea for children under age 3 were calculated at 0.6-1 billion dollars per year. acute diarrhea in young children is almost always caused by infections or antibiotics. the rate of diarrhea associated with antibiotic usage is 20-35%, with children 3-36 months receiving on average 2-3 antibiotic prescriptions per year. studies have shown that diarrhea due to either antibiotics or infections is caused by disturbances of the microflora of the gastrointestinal tract. the current treatment for diarrhea in young children is oral rehydration, which is used to treat dehydration but plays no role in prevention. probiotics are live microorganisms which, when administered in sufficient amounts, may improve health. probiotics have the potential to treat and prevent diarrhea by improving the intestinal flora when disturbed by events such as antibiotics. important to their use is that they are of human origin, survive passage through the gut, and are safe in very large dosages. studies have examined the potential health benefits of probiotics in the prevention and treatment of both antibiotic and infectious diarrhea. the probiotics have generally been given as supplements or pills. in placebo controlled randomized studies using these techniques, probiotics have generally been shown to decrease antibiotic associated diarrhea by 15-25% over placebo. other studies have enrolled children with acute diarrhea, generally from rotavirus, and found a 30-50% cure rate in the probiotic group over placebo. kefir, available in the united states, is a milk product derived by the action of ten probiotics. a daily dose of 10\^6-10\^9 colony forming units of probiotics has been studied and recommended for health benefits.

Eligibility criteria:
inclusion criteria: * ability to speak and write english * aged 1-5 years * male or female * diagnosed with an upper respiratory infection and placed on a penicillin class antibiotic regimen for 10 days exclusion criteria: * developmental delays * chronic conditions, such as diabetes or asthma, that require medication * prematurity, birth weight \<2500 grams * allergy to kefir and/or milk * active diarrhea * congenital anomalies * failure to thrive * parental belief of lactose intolerance

Keywords: probiotic cultured dairy drink health 10 day antibiotic otherwise healthy
taxotere, cisplatin, and cpt-11 in advanced solid tumor malignancies

Conditions: Solid Tumor

Summary: the purpose of this study is to find the highest dose of the combination of taxotere, cisplatin and cpt-11, that can be given without causing severe side effects. we also want to test the safety of this drug combination and see what effects (good and bad) it has on patients with advanced cancer for which there is no known curable treatment.

* this is a phase i clinical trial. we are unsure of the safest and most effective dose of the drugs and therefore are planning on treating 3-6 patients with a given dose before increasing to higher dose levels. * each patient will receive approximately two cycles of therapy. on day one and day eight, they will receive taxotere, cisplatin and cpt-11 intravenously. the cycle will begin again on day 22. * the following tests and procedures will be performed: cat scan prior to beginning therapy, after every 2 cycles of therapy, and at the end of the study; physical exam before each course of therapy; vital signs before and with each dose of therapy; routine blood tests before starting therapy and weekly during treatment; chest x-ray and echocardiogram before starting therapy and; toxicity assessment each week of therapy. * patients will remain on the study as long as their cancer responds to treatment and they do not have unacceptable side effects.

Eligibility criteria:
inclusion criteria: * histologically confirmed, incurable solid tumor malignancy * 18 years of age or older * ecog performance status of \< or = to 2 * life expectancy of greater than 12 weeks * wbc \> 3,000/mm3 * anc \> 1,500/mm3 * platelet count \> 100,000/mm3 * total bilirubin within normal limits * sgot \< 2.5 x uln * alkaline phosphatase \< 4 x uln exclusion criteria: * prior chemotherapy for the treatment of metastatic or recurrent cancer * prior radiotherapy to greater than or equal to 15% of bone marrow * prior pelvic radiation therapy * prior nitrosoureas or mitomycin c * myocardial infarction in the past 6 months * major surgery in past 2 weeks * uncontrolled serious medical or psychiatric illness * uncontrolled diarrhea * peripheral neuropathy \> grade 1 * pregnant or lactating women * clinically apparent central nervous system metastases or carcinomatous meningitis

Keywords: advanced solid tumor malignancy cisplatin cpt-11 taxotere
study of subjects with diabetic foot ulcer (dfu)

Conditions: Diabetic Foot

Summary: foot ulceration is a common and costly complication of diabetes. gsk1278863 is a topical drug, which is being developed to treat wounds associated with dfu. the aim of this study is to explore the symptoms and impacts of dfu from the subject perspective and to elicit in-depth information about dfu signs and symptoms, impacts on functioning and health-related quality of life (hrqol). adult dfu subjects with current or recent (within last six months) neuropathic foot ulcers will be eligible to participate in this prospective, cross-sectional interview study. approximately 20 dfu subjects will be recruited from up to three clinical sites. potential subjects will be pre-screened and then contacted to gauge interest in the study. interested subjects will be screened and eligible subjects will consent to release contact information to research staff. research staff will contact the subject to schedule interviews. this study will include concept elicitation interviews over the telephone or in-person by trained and experienced interviewers. in-person interviews will be conducted in a private room at the clinical site. all interviews will be conducted in english and will be guided by semi-structured interview guides. all subjects will provide written consent prior to the start of the interview.


Eligibility criteria:
inclusion criteria: * adult male or female, 18 years of age or over * has a diagnosis of type 1 or 2 diabetes * has a diagnosis of neuropathic foot ulcer with minimal, if any, ischemia present (ankle-brachial index \[abi\] \>=0.6 or transcutaneous oxygen \[tcpo2\] \>35 millimeter of mercury \[mmhg\]) * wagner grade 1 or 2 * currently receiving treatment for a diagnosis of diabetic foot ulcer or have had an active foot ulcer healed within the last 6 months * is not currently enrolled in a clinical trial for dfu * is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study * is willing and able to participate in the study which includes a 60 minute interview * willing to have interview audio-recorded * speaks english as primary language exclusion criteria: * subjects who does not meet the inclusion criteria * has diagnosis of critical limb ischemia * has ulcers that have exposure of tendon, bone, or joint capsule (wagner grade \>2) * has osteomyelitis or gangrenous ulcers * is currently enrolled in a clinical trial for dfu * is unwilling or unable to sign an informed consent document indicating that they understand the purpose and procedures of the study * is unwilling or unable to participate in the study which includes an interview of up to 60 minutes in duration
norursodeoxycholic acid in the treatment of primary sclerosing cholangitis

Conditions: Primary Sclerosing Cholangitis

Summary: evaluation of the efficacy of different doses of nor udca vs. placebo for the treatment of primary sclerosing cholangitis (psc). identification of optimal dose(s)for the treatment of psc.

double-blind, randomized, multi-center, placebo-controlled, comparative exploratory phase ii-finding trial.the study will be conducted with four treatment groups in the form of a parallel-group comparison and will serve to compare oral treatment with either 500 mg/d, 1000 mg/d or 1500 mg/d norursodeoxycholic acid capsules vs. placebo capsules for the treatment of psc.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. verified diagnosis of psc 3. psc patients with or without ibd 4. women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control. exclusion criteria: 1. history or presence of other concomitant liver diseases 2. treatment with udca within 8 weeks prior to baseline visit. 3. child b/c liver cirrhosis 4. total bilirubin \> 3.0 mg/dl at screening or baseline. 5. any relevant systemic disease 6. tsh\>uln at screening 7. any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder 8. any active malignant disease 9. known intolerance/hypersensitivity to study drug 10. existing or intended pregnancy of brest feeding 11. simultaneous participation in another clinical trial

Keywords: psc
mixed-methods study of multidimensional adversity in inner-city african american adults with chronic kidney disease and type 2 diabetes mellitus

Conditions: Diabetic Nephropathy Type 2 - Uncontrolled; Diabetes Mellitus, Type 2; Chronic Kidney Diseases

Summary: the overarching goal of this study is to understand facilitators and barriers to self-care, develop and refine a culturally tailored intervention to improve clinical outcomes, quality of life (qol), and self-care behaviors in african american adults with diabetic kidney disease (dkd) experiencing multidimensional adversity (mda) and living in the inner-city.

multidimensional adversity (mda), defined as having three or more social adversities such as loss of employment, housing instability, food insecurity, transportation needs, utility needs, interpersonal safety, and financial strain impacts the complex self-management of dkd such as self-monitoring and behavior modification. this study utilizes a convergent parallel mixed methods study design to understand facilitators and barriers to care and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in african american adults with dkd experiencing mda and living in the inner-city. aim 1 (qualitative): identify facilitators and barriers to care in african american adults with dkd experiencing mda and living in the inner-city using in-depth patient and stakeholder interviews. aim 2 (quantitative): examine the effect of increasing burden of mda on clinical outcomes (hemoglobin a1c, blood pressure, lipids), quality of life, and self-care behaviors (diet, exercise, and medication adherence) in a sample of 300 african american adults with dkd experiencing mda and living in the inner-city. aim 3 (integrative): integrate findings from aims 1 and 2 and develop a culturally tailored intervention to improve clinical outcomes, quality of life, and self-care behaviors in african american adults with dkd experiencing mda and living in the inner-city.

Eligibility criteria:
inclusion criteria: 1. self- report as aa/black 2. age ≥18 3. screen positive for 1 or more adversities using the centers for medicare and medicaid services accountable health communities health-related social needs screening tool 4. self-reported type 2 diabetes and self-report or screen positive for chronic kidney disease (ckd) 5. able to communicate in english. exclusion criteria: 1. cognitive impairment at screening visit 2. active psychosis 3. active alcohol or drug abuse/dependency

Keywords: social risk factors
progranulin and ctrp3 in metabolic syndrome

Conditions: Metabolic Syndrome

Summary: inflammation has been known to be a pivotal pathogenic mechanism of obesity-related disorders such as type 2 diabetes, metabolic syndrome and atherosclerosis. adipose tissue functions as a major endocrine organ by adipokine mediated modulation of a number of signaling cascades in target tissues, that has pro-inflammatory or anti-inflammatory activities. progranulin and ctrp3 are recently discovered novel adipokines. therefore, the investigators tried to clarify the clinical meaning of these two adipokines in the subjects with or without metabolic syndrome


Eligibility criteria:
inclusion criteria: * 20\<age\<80 * apparently healthy subjects exclusion criteria: * a history of cvd * diabetes * stage 2 hypertension * malignancy * severe renal or hepatic disease