Kornimate/medical-research-clean huggingface dataset:
community based study of adult onset asthma

Conditions: Asthma; Lung Diseases

Summary: to identify the role of irritant exposure in adult-onset asthma by simultaneously using both clinical and case control methods in a community-based perspective study of asthma incidence.

background: asthma incidence is increasing, and in adults work-related exposures may be an important factor-occupational asthma (oa) incidence increased 70 percent over the last decade according to a recent registry based study. the true contribution of occupational exposures to adult-onset asthma is unknown because the methods for measuring oa give conflicting results. methods based on surveillance of clinically diagnosed oa account for less than one to five percent of adult-onset asthma. however, case-control methods of measuring asthma risk by industry suggest that six to 33 percent of adult-onset asthma is caused by workplace exposures. the conflict may occur because of two factors: physicians often fail to diagnose and report oa, and irritant exposures may increase the risk the risk of asthma without causing cases that meet the clinical definition. both factors have important implications for proper treatment and prevention of asthma in adults. design narrative: clinical and case control methods were used to identify the role of irritant exposure in adult-onset asthma in a community-based prospective study of asthma incidence. the study cohort was a typical us working population enrolled in an hmo. additional benefits of the study design were the opportunities to validate a questionnaire for exposure assessment and for detection of work-related asthma. specifically, the study: 1) investigated incident cases in a cohort of over 80,000 adults over three years and determined the proportion that met a clinical definition of occupational asthma (oa); 2) used a nested case-control study to determine the incidence of all asthma by occupation and workplace exposure; 3) determined whether clinical oa accounted for the excess incidence of adult-onset asthma associated with workplace exposure to sensitizers and irritants; 4) prospectively followed asthmatics for two years after diagnosis to determine the impact of adult-onset asthma on lung function, employment, income, and quality of life, and to determine whether prognosis differed for clinical oa and for asthma associated with workplace irritant exposure; 5) tested an intervention designed to increase appropriate clinical diagnosis, and thus secondary prevention of oa. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
risk of celiac disease and age at gluten introduction

Conditions: Celiac Disease

Summary: the purpose of this study is to determine whether age at introduction of gluten-containing cereals (e.g. wheat) plays a role in influencing the risk of celiac disease (cd) development in infants with a first-degree relative affected by cd.

we undertook a prospective study to establish the incidence of cd autoimmunity related to the timing of gluten exposure in at-risk infants. infants at family risk for cd (at least one first-degree relative affected) are enrolled in this prospective, multicentre, intervention study conducted in italy. infants are randomly assigned to introduce gluten at either 4-6 or 12 months (groups a and b, respectively) and then enter a follow-up period of 5 years. duration of breastfeeding and types of formulas, adherence to the dietary plan, amount of gluten administered, and clinical data are collected by phone or direct interview at 4, 7, 9, and 12 months of age. hla (human leucocyte antigene) status and cd serology (anti-transglutaminase and other autoantibodies) are tested at 15, 24, 36 and 60 months of age.

Eligibility criteria:
inclusion criteria: * newborn in a family where a first-degree relative is already affected with biopsy-proven cd
azd6244 vs. capecitabine (xeloda®) in patients with advanced or metastatic pancreatic cancer, who have failed first line gemcitabine therapy

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to assess the efficacy and safety of azd6244 (arry-142886)versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line therapy with gemcitabine. following baseline assessments, a minimum of 64 patients in approximately 5-6 centers from the us will be treated with either azd6244 or capecitabine. treatment will be continued for as long as the patients receive clinical benefit. the status of all patients will be checked (whether they are still taking treatment or not) approximately 3 months after the last patient has entered the study.


Eligibility criteria:
inclusion criteria: * confirmed with pancreatic cancer * have failed first line gemcitabine therapy exclusion criteria: * previous therapy with egfr inhibitor, mek inhibitor or capecitabine. * any recent surgery, unhealed surgical incision or severe condition such as uncontrolled cardiac disease or chronic gastrointestinal diseases.

Keywords: advanced pancreatic cancer metastatic pancreatic cancer azd6244
a placebo controlled trial of bempegaldesleukin (bempeg; nktr-214) with standard of care in patients with mild covid-19

Conditions: Covid-19; Coronavirus Disease 2019

Summary: the main purpose of this phase-1b, multicenter, randomized double-blind, placebo-controlled, trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of bempegaldesleukin (bempeg; nktr-214) in combination with standard of care (soc) in adult patients with mild covid-19 (coronavirus disease 2019). the trial will also define the recommended phase 2 dose (rp2d) of bempegaldesleukin in patients with mild covid-19.


Eligibility criteria:
inclusion criteria: * male or female patients, age 18 years or older on the day of signing the informed consent form. * agrees to admission to an in-patient facility for monitoring from days 1 to 8, inclusive. * symptoms of mild illness with covid-19 without shortness of breath, dyspnea, or clinical signs indicative of more serious covid-19. * laboratory confirmed sars-cov-2 infection within 4 days prior to the screening visit or during the 7-day screening period. * respiratory rate \< 20 breaths per minute, heart rate \< 90 beats per minute (bpm). * oxygen saturation by pulse oximetry \> 93% on room air. * body mass index \< 35 kg/m2. * estimated glomerular filtration rate (egfr) ≥ 30 ml/min. * alanine transaminase (alt) or aspartate transaminase (ast) \< 2 x upper limit of normal (uln) and total bilirubin \< 1.5 x uln. * agrees to not participate in another clinical trial for the treatment of covid-19 while on study unless the patient's condition has worsened and is considered to be moderate, severe, or critical by the investigator. exclusion criteria: * shortness of breath, hypoxia, or signs of serious lower airway disease. * c-reactive protein, lactate dehydrogenase (ldh), or interleukin-6 (il-6) \> 1.5 x uln. * d-dimer or ferritin \> 1.5 x uln. * imminently requiring, or currently on, mechanical ventilation or extracorporeal membrane oxygenation (ecmo). * systolic blood pressure \< 90 mm hg or diastolic blood pressure \< 60 mm hg. * evidence of acute respiratory distress syndrome (ards) or systemic inflammatory response syndrome (sirs)/shock. * known cardiovascular history, including unstable or deteriorating cardiac disease. * autoimmune disease. * history of pulmonary embolism (pe), deep vein thrombosis (dvt), or prior clinically significant venous or non-cerebrovascular accident/transient ischemic attack arterial thromboembolic event. * central nervous system disease or dysfunction. * requirement for \> 2 anti-hypertensive medications. * unwilling to refrain from alcohol consumption from day 1 of admission to the in-patient facility until discharge from the facility. * adrenal insufficiency. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: bempeg bempegaldesleukin cd122 cd122-biased agonist cd122-biased cytokine coronavirus disease covid-19 il-2 receptor agonist lymphopenia mild covid nktr-214 sars-cov-2 severe acute respiratory syndrome coronavirus 2
effect of digital health coaching program on self-efficacy and patient reported outcomes of patients with newly diagnosed acute myeloid leukemia or chronic lymphocytic leukemia

Conditions: Acute Myeloid Leukemia; Chronic Lymphocytic Leukemia

Summary: this trial studies the effect of a digital health coaching program on self-efficacy and patient reported outcomes of patients with acute myeloid leukemia or chronic lymphocytic leukemia that is newly diagnosed. a digital health coaching program may help leukemia patients report information about their health while receiving treatment, which may lead to improvement in overall health.

primary objective: i. to evaluate the effect of digital health coaching on self-efficacy among two cohorts of individuals with acute myeloid leukemia (aml) and chronic lymphocytic leukemia (cll), respectively, as measured by the cancer behavior inventory (cbi version \[v.\] 3). secondary objectives: i. to evaluate the relationship between self-efficacy and patient reported outcomes among individuals with and without digital health coaching, specifically: ia. the physiologic and psychosocial outcomes of individuals with aml and cll as measured by the functional assessment of cancer therapy-leukemia questionnaire (fact-leu). ib. the symptom experience of individuals with aml and cll as measured by the md anderson symptom inventory (mdasi). ic. the financial toxicity of individuals with aml and cll as measured by the comprehensive score for financial toxicity (cost). outline: patients are randomized to 1 of 2 groups. group i: patients receive the pack health digital health coaching program over 3 months consisting of communication initiated by either the pack health coach or the patient through either text, e-mail, or phone call, to provide education and support related to a specific topic such as fatigue, nutrition, or exercise. group ii: patients receive standard of care support services consisting of a telephone triage line that patients may call when experiencing physical or psychological concerns, or with any other questions related to their disease or treatment.

Eligibility criteria:
inclusion criteria: * able to read, speak and consent in english * individuals newly diagnosed with either acute myelogenous (aml) or chronic lymphocytic leukemia (cll), defined as within three months of diagnosis * internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments * individuals with a prior history of myelodysplastic syndrome (mds) will be allowed to enroll exclusion criteria: * individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment) * individuals who have undergone treatment for previous diagnoses of leukemia * individuals for whom there is documentation of inability to provide consent in the medical record
cold stress stimulate the browing of subcutaneous white adipose in healthy adults

Conditions: Obesity; Type 2 Diabetes

Summary: adipose tissues, which include white adipose tissue (wat) and brown adipose tissue (bat), play an essential role in regulating whole-body energy homeostasis. recent studies also reveal the presence of a subset of cells in wat that could be induced by environmental or hormonal factors to become ''brown-like'' cells, and this ''beigeing'' process has been suggested to have strong antiobesity and antidiabetic benefits. more recently, same studies showed that cold stress stimulate the browning of subcutaneous white adipose. however, to the investigators knowledge, there are no direct data that clearly show that cold stress can promote the browning of subcutaneous white adipose.

individuals have cold exposure at 15c for 2 hr everyday for one week.biopsy for subcutaneous white adipose was performed before and after one week cold exposure programme under local anesthesia. measure the brown fat characteristics of biopsy samples. the expression levels of uncoupling protein-1 (ucp-1), peroxisome proliferator-activated receptor (ppar)-r, peroxisome proliferator-activated receptor r coactivator 1 a (pgc1a) , growth factor receptor binding protein-10 (grb10), pr domain containing 16 (prdm16) will be determined before and after cold stress programme from the biopsy samples. in addition, a combination of pet and computed tomography (ct) - with the glucose analogue 18f-fluorodeoxyglucose (18f-fdg) as a tracer will be performed for brown adipose tissue before and after cold stress programme.

Eligibility criteria:
inclusion criteria: * healthy men * 18-60 years old * bmi 20-28 kg/m2 exclusion criteria: * bmi \< 20 kg/m2 * bmi \> 28 kg/m2 * female

Keywords: brown adipose tissue subcutaneous white adipose tissue white adipose tissue
the effect of physical therapy modalities and kinesio taping in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis; Knee Pain Chronic

Summary: osteoarthritis (oa) is the most common degenerative joint disease with pathological structural and functional disorders all over the world. 27 million patients diagnosed with osteoarthritis in the usa alone.(1-2)

osteoarthritis (oa) is the most common degenerative joint disease with pathological structural and functional disorders all over the world. 27 million patients diagnosed with osteoarthritis in the usa alone.(1-2) the primary risk factor for oa is age however ; it is a multifactorial disease, including injury and genetic mutations.(3-6) the knee is the most commonly involved joint in oa. in the united states, about 14 million people is presumed to have symptomatic knee osteoarthritis. typical oa manifests as joint pain which is exacerbated by activity and relieved by rest. in advanced stage, pain at rest and at night and morning stiffness lasting no more than 20-30 minutes can be seen. (2) the diagnosis is based on a detailed anamnesis, a complete physical examination, and diagnostic imaging. imaging findings include joint space narrowing, osteophytes, pseudocyst and subchondral sclerosis in the subchondral bone.(9) pharmacological and non-pharmacological treatments are applied. exercise, conventional physical therapy ( hotpack, therapeutic ultrasound, tens) and kinesioband are some of the non-pharmacological treatments.

Eligibility criteria:
inclusion criteria: over 50 ages stage 2-3 osteoarthritis according to kellgren lawrence lectures exclusion criteria: presence of acute infection the patient has a history of knee surgery presence of rheumatological disease history of malignancy major knee trauma presence of crystal arthropathy presence of acute trauma/fracture history of avascular necrosis the presence of contracture in the knee using analgesic or anti-inflammatory drugs in the last 1 week using oral or intramuscular corticosteroids in the last 3 months intra-articular injection of the knee in the last 6 months receiving physical therapy modalities from the knee area in the last 1 year diseases such as dementia that may cause loss of cognitive functions

Keywords: kinesio tape kinesiophobia therapeutic ultrasound exercise ultrasound
a study to evaluate the safety, tolerability, and pharmacokinetics of pb-718 injection in chinese obese subjects.

Conditions: Obesity

Summary: the trial is conducted in a single center, randomized, double blind, placebo controlled, dose increasing design. to evaluate the safety, tolerability, pharmacokinetics(pk) characteristics, efficacy and immunogenicity of pb-718 injection in chinese obese subjects.

the trial is conducted in a single center, randomized, double blind, placebo controlled, dose increasing design. to evaluate the safety, tolerability, pk characteristics, efficacy and immunogenicity of pb-718 injection in chinese obese subjects. the study consists of three dose groups, each of which is planned to include 12 subjects (9 receiving the study drug and 3 receiving placebo), for a total of 36 patients. subjects will receive 12 weeks（for cohort 1 and 2） or 18 weeks(for cohort 3) of treatment after screening and complete 8 weeks of safety follow-up.

Eligibility criteria:
inclusion criteria: 1. chinese male or female subjects aged 18-60 years (both inclusive). 2. body weight ≥70 kg(male) or 60 kg(female), and body mass index (bmi) ≥28.0 kg/m2 at screening. 3. weight change \<5% in the past 3 months before screening. exclusion criteria: 1. fpg ≥7.0mmol/l or glycosylated hemoglobin (hba1c) ≥6.5% or diagnosed diabetes 2. fpg \<3.9 mmol/l at screening and/or a history of hypoglycemia. 3. history of cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones. 4. abnormal thyroid-stimulating hormone(tsh), free triiodothyronine(ft3), free thyroxine(ft4) or diagnosed thyroid dysfunction 5. history of multiple endocrine neoplasia syndrome type 2 (men-2) or medullary thyroid carcinoma (mtc). 6. diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening 7. systolic blood pressure \> 160 mmhg and/or diastolic blood pressure \> 100 mmhg at screening or randomization. 8. pr intervals \> 210 msec and/or qrs wave group time limit \> 120 msec and/or corrected qt interval using fridericia's formula（qtcf）\> 450 msec at screening or randomization. 9. serum amylase or lipase \> 3× upper limit of normal (uln) at screening or before randomization, or previously diagnosed acute/chronic pancreatitis. 10. low density lipoprotein cholesterol(ldl-c) ≥4.40 mmol/l or triglyceride (tg) ≥5.65 mmol/l. 11. use of any approved or unapproved drugs or products that have an effect on body weight within 3 months prior to screening 12. history of bariatric surgery for weight loss 1 year before screening.
prophylactic muscle flaps in vascular surgery

Conditions: Vascular Graft Infection

Summary: previous studies have suggested that prophylactic muscle coverage in high-risk patients undergoing revascularization procedures through a groin incision have the potential to reduce rates of complications and re-operation. this is a prospective randomized control trial to test this hypothesis at the university of wisconsin hospitals and clinics.

the incidence of graft infections after groin dissection for lower limb revascularization is estimated to be between 2 and 20%. infection requiring re-operation and muscle flap coverage for salvage is estimated to be between 11 and 13%. retrospective studies have endeavored to create risk calculators to better predict patients at high risk of need for muscle flap salvage. fischer et al. suggest that in high-risk patients, prophylactic muscle flaps can reduce complications from 70% to 10%, rates of infection from 70% to 3% and wound breakdown from 48% to 5%. cost-savings of around $400,000 per year with the use of prophylactic muscle flaps are estimated. unfortunately, the retrospective nature of the fischer et al. study, lack of standardization of patients receiving prophylactic muscle flaps, and use of the same cohort for the risk calculator as for the outcomes analysis all reduce the generalizability and reproducibility of these results. at the university of wisconsin hospitals and clinics, muscle coverage is routinely used in cases of infection or lymph leak but is not systematically used in prophylactic settings. this is because it is generally left to surgeon preference-if they feel like a muscle flap is needed (for a variety of non-standardized anatomic/surgical or patient factors) then it is performed. muscle coverage of vascular grafts in and of itself is not an experimental procedure and has been performed for decades. the goal of this study is to determine whether prophylactic muscle flaps in high-risk patients can a) reduce the rates of infection requiring re-operation, and b) reduce the significant morbidity associated with other non-operative complications. this will be the first prospective, randomized control trial to address this issue.

Eligibility criteria:
inclusion criteria: * open lower extremity arterial revascularization * groin incision * "high-risk" patients based on risk calculation exclusion criteria: * pregnant or breast-feeding * any person with diagnosis of an active groin infection preoperatively * incarcerated patients * unstable patients going directly to the or for whom the study consent process would delay care, and those who cannot give informed consent to participate in the research study will be excluded * if a surgeon feels that a patient should or should not receive a flap based on intra-operative or pre-operative characteristics, those patients will be excluded from the study * prior to a scheduled groin intervention case a prior authorization will be sent to the participant's insurance company. if the groin flap is denied, which would be highly unusual, then the participant would be excluded from the study.
portable oxygen concentrator to improve quality of life in chronic obstructive pulmonary disease

Conditions: COPD

Summary: * evaluate subjects in an prospective observational study * subjects will be administered scientifically validated questionnaires * determine the affect of the portable oxygen concentrator (poc) on improvements in: 1. exercise capability, dyspnea and quality of life as primary endpoints 2. utilize: 1. baseline dyspnea index (bdi) 2. transitional dyspnea index (tdi) 3. chronic respiratory disease questionnaire (crq) 4. six minute walk test (6mwt) 5. epworth sleepiness scale (ess) * the secondary endpoints will be: 1. rate of exacerbations, sleep quality 2. health care utilization (emergency room encounters, hospital admissions)

evaluate subjects in an prospective observational study in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine the affect of the portable oxygen concentrator on improvements in exercise capability, dyspnea and quality of life as primary endpoints, utilizing the baseline dyspnea index (bdi), transitional dyspnea index (tdi), the chronic respiratory disease questionnaire (crq) and six minute walk test (6mwt). the secondary endpoints will be rate of exacerbations, sleep quality (reported as number of hours sleep improvement; utilize epworth sleepiness scale \[ess\]), and health care utilization (emergency room encounters, hospital admissions).

Eligibility criteria:
inclusion criteria: * primary diagnosis of chronic obstructive pulmonary disease (copd) * clinically stable disease at the time of consent * current prescription of oxygen; with previous or current oximetry suggesting desaturation at rest or during exercises (oxygen saturation ≤88% on at least one occasion) * highest measured fev1, 70% predicted; and * highest measured fev1/fvc, 70% predicted * capable of giving informed consent * currently using oxygen system that is either a portable tank; liquid or other portable oxygen concentrator (poc) * mobility without a walker, cane or rollator * spo2 ≥ 92% on portable oxygen concentrator (poc) at rest and activity * non-smoker at time of consent exclusion criteria: * cardiovascular disease as defined in new york heart association functional class iii * degenerative bone or joint disease that limits mobility and ability to perform activities of daily living and/or exercise * current homeless persons * active drug/alcohol dependence * recent abuse history within the past two years * clinically unstable at the time of consent * currently a tobacco smoker

Keywords: copd ltot long-term oxygen therapy portable oxygen concentrator quality of life six minute walk distance test