Kornimate/medical-research-clean huggingface dataset:
proenkephalin for prediction of contrast-associated kidney events

Conditions: Contrast-induced Nephropathy; Acute Kidney Injury; Coronary Artery Disease

Summary: currently, contrast-induced kidney injury cannot be diagnosed on the day of cardiac catheterization. recently, proenkephalin (penkid) was introduced as a new glomerular filtration marker. the aim of this study is to investigate whether the change in penkid level allows for early detection of affected patients.

use of contrast media is necessary for diagnostic imaging and percutaneous coronary intervention. however, contrast-induced kidney injury, a complication of contrast use, has been identified as the most frequent cause of hospital-acquired acute kidney injury and is associated with poor prognosis. currently, contrast-induced kidney injury cannot be diagnosed on the day of cardiac catheterization or on the following day, when the majority of patients who undergo elective cardiac catheterization are discharged from the hospital in the real-world setting. recently, proenkephalin (penkid) was introduced as a new glomerular filtration marker, which is capable of identifying normal subjects at high risk of future decline in renal function. the aim of this study is to investigate whether the change in penkid level on the day following cardiac catheterization can predict kidney injury before hospital discharge and thus allows for early detection of affected patients. for this purpose a total of 214 consecutive patients who undergo routine cardiac catherization will be recruited, and blood will be drawn at three time-points: immediately before catherization, 12-24 hours after catheterization and 4-8 weeks after discharge. creatinine will be measured for endpoint definition, while the markers urea, crp (c-reactive protein), ngal (neutrophil gelatinase-associated lipocalin), kim-1 (kidney injury marker-1), cystatin c, supar (soluble urokinase-type plasminogen activator receptor), and penkid will be measured as biomarkers of interest. the main outcome measure is sustained kidney injury (ski), which is defined as an increase above 20% in serum creatinine between time-points 1 and 3. the main test is whether the change in biomarkers between baseline and immediately before discharge (time-points 1 and 2) can predict the development of sustained kidney injury.

Eligibility criteria:
inclusion criteria: * \> 18 years of age * planned elective or urgent coronary or non-coronary angiography with iodinated contrast media * ability to provide informed consent exclusion criteria: * current use of renal replacement therapy/hemodialysis * life expectancy \< 6 months

Keywords: cin coronary angiography contrast angiography
i-cbt tailored to patients with cardiovascular disease and insomnia

Conditions: Insomnia; Cardiovascular Diseases

Summary: the hit-it study is based on an internet-based cognitive behavioral therapy program tailored to patients with different types of cardiovascular diseases and insomnia. a randomized controlled trial design is used. a 9 weeks internet-based cognitive behavioral therapy intervention vs a 3 weeks sleep hygiene education.

design: randomized controlled trial with 1-year follow-up. all patients with cardiovascular disease (i.e., myocardial infarction, heart failure, atrial fibrillation and angina) from 4 primary care centers will be screened for insomnia and during a clinical examination diagnosed by a physician specialized in sleep medicine. intervention: 9 weeks internet-based cognitive behavioral therapy for insomnia (1 week introduction, 2 weeks psycho education on cardiovascular disease/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction) vs 3 weeks internet-based sleep hygiene education. questionnaires: sleep (pittsburgh sleep quality index, insomnia severity index, sleep diary), depressive- and cardiac symptoms (patient health questionnaire-9, cardiac anxiety questionnaire) and quality of life (sf-12) at baseline, during and after intervention (after 6 and 12 months).

Eligibility criteria:
inclusion criteria: * age over 18 years * having a clinical diagnose of insomnia * being treated for heart failure, coronary artery disease or atrial fibrillation * access to a computer with an internet connection, access to a mobile phone and was willing to participate in a treatment for their insomnia. exclusion criteria: * no access to internet, computer or cellphone. * not understanding the swedish language * suffering from cognitive disabilities, severe psychiatric disease, severe somatic disease or sleep apnea * suffering from drug abuse * been hospitalised for heart failure, coronary artery disease or atrial fibrillation in the last four weeks * expected survival less than 12 months
vitamin d deficiency as a risk factor for the development and malignant transformation of oral lichen planus

Conditions: Oral Lichen Planus; Vitamin D Deficiency

Summary: to examine how a lack of vitamin d may increase the risk of developing oral lichen planus and its malignant progression while accounting for sex, food habits, sunlight, socioeconomic level, and psychological variables.


Eligibility criteria:
inclusion criteria: * (group a) patients presenting with a clinical picture and histological findings that confirm the diagnosis of olp * (group b) age, sex, and dietary habits matched healthy controls. exclusion criteria: * (1) subjects who have been receiving any kind of vd supplements, multivitamins, or any drug that may affect vd measurements * (2) patients with suspected restoration-related or smokeless tobacco-related lesions. * (3) patients with any systemic medical condition or pregnant females. * (4) patients with vd toxicity (vd≥100 ng/ml).
special investigation of clarith/klaricid in patients with non-tuberculous mycobacterial pulmonary infections

Conditions: Mycobacterium Infections, Atypical

Summary: to evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with non-tuberculous mycobacterial pulmonary infections.

background: the revised 2007 american thoracic society/infectious diseases society of america guidelines recommend a clarithromycin-based combination therapy for treatment of mycobacterium avium complex (mac) lung disease and stipulate approximately 1 year of continuous treatment after bacilli negative conversion. however, supporting data are insufficient. objectives: to obtain data on the clinical outcome of clarithromycin-based regimens by conducting a nationwide prospective study mainly of mac lung disease. methods: in accordance with the guidelines, patients were enrolled in this survey according to their chest radiographic findings and microbiologic test results. they were treated with a multi-drug regimen including clarithromycin, rifampicin, and ethambutol (clarithromycin -based regimen) until bacilli negative conversion on continual treatment for 1 year. data were collected "pre-administration," "on the bacilli negative conversion," and "at 6 months after the end of treatment."

Eligibility criteria:
inclusion criteria * patients with pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with klaricid exclusion criteria * contraindications according to the package insert * patients with a history of hypersensitivity to any ingredient of klaricid * patients who are receiving pimozide, ergot-containing products, or cisapride * patients who have aids (acquired immune deficiency syndrome)

Keywords: mycobacterium infections, atypical
nutrition based computerized predictive method for morbidity & mortality risk in hd patients. assisng nir for blood cr

Conditions: Malnutrition; Inflammation; Morbidity; Mortality

Summary: the aim of the study is to develop a simple computer program, evaluating nutritional status of hd patients. the programming will enable to perform a nutritional screening, based on biochemical measures, taken as part of hd patients' routine care every month. the program will identify patients at risk of malnutrition, define the degree of malnutrition, and identify patients who at risk for increased morbidity and mortality. patients who are at risk of malnutrition will be treated by a standard nutrition; dietary counseling (high protein diet, appropriate calories intake and use of oral supplementation. intra-dialytic parenteral nutrition (idpn) will be used for patients who fail to improve nutrition status by standard nutrition care, as a second line treatment. the effect of idpn on their nutrition status will be evaluated. a sub group of 30 patients will provide blood smample to assess a nir method for cr determination as creatinine is one of the parameters our nutrition score is based on.

30 patients will randomly be selected for sga examination and comparison to the mark results every month. frequency and duration of hospitalizations within the 5-month collection period will documented, mortality will be documented as well. effect of different nutritional supplementations or idpn will be assessed. the mark nutrition screening will be used for all patients at the beginning of every month. monthly biochemical data using a blood sample taken immediately before dialysis will be used to calculate a value between 0-100 showing patient's monthly nutritional status. data for the sga will be collected for the same dialysis patients randomly selected at the same month. the nutritional state of the patients according to the sga will be assessed by two investigators. a statistical test will be held for agreement between observers (cohen's k concordant coefficient). a sub group of 30 patients will provide blood smample to assess a near infra red (nir) method for cr determination. application of chemometric approach will serve for constructing a fitting curve between tradtional cr measurment with nir method.

Eligibility criteria:
inclusion criteria: * all dialysis patients in wolfson medical center dialysis unit above the age of 18 years and on dialysis more than 3 months. exclusion criteria: * patients with bilateral plegia. hemiplegic organs of a patient (not the entire patient).
reducing bacteria that cause tooth decay

Conditions: Caries, Dental; Cariostatic Agents

Summary: the purpose of the study is to determine the effect of a two-step mouth rinsing procedure on reducing the germs (mutans streptococci) that cause tooth decay. we hope that the two-step mouth rinse (0.3% naocl followed by 10% povidone iodine) decreases the tooth causing germs better than the one-step mouth rinse (10% povidone iodine). the mouth rinse for both treatment groups is done only once at the beginning of the study after the initial saliva samples are taken, and before a detailed examination of the teeth and gums. it is hypothesized that the treatment group receiving the naocl and povidone iodine will have significantly lower microbial counts than the control group (povidone iodine) because the naocl will disrupt the microbial biofilm and make the povidone iodine more effective in decreasing the microbes in the biofilm. microbial counts are made from salivary samples taken from participants at baseline, one week, one month, two months and three months. the samples are tested by two commercial methods for determining microbial counts. the cariscreen test is a rapid bioluminescence assay that quantitates the total number of all of the organisms present. the crt test requires a culture media that is specific for the two germs (s. mutans and lactobacillus) strongly associated with tooth decay. the results of the crt test are read after three days of incubation.


Eligibility criteria:
inclusion criteria: * being over 20 years of age; * having at least one obviously cavitated tooth; * refraining from smoking, brushing the teeth and using a mouthwash the day of the bacterial sampling; * refraining from using a commercial mouth rinse during the three months of the study; * having any two of the following risk factors in the caries management by risk assessment (cambra) protocol which qualifies as a high caries risk. the high caries risk factors included: * receiving fillings within the past three years; * snacking frequently between meals; * presenting with hyposalivation due to medication, radiation or systemic conditions; * visual presence of heavy plaque accumulation; * and a minimum of 20 natural teeth. exclusion criteria: * using a systemic antibiotic within the past three months; * currently receiving dental treatment or planning to receive treatment within the next three months (emergency treatment allowed); * being pregnant or nursing; * any thyroid disease or sensitivity to iodine; * the use of a commercially available mouth rinse the day of the screening examination; * smoking, brushing the teeth and using a mouth rinse the day of the bacterial sampling; * not being able to make morning examinations.
effect of t6 dermatome electrical stimulation on gastroduodenal motility in healthy volunteers

Conditions: Weight Loss

Summary: the investigators are doing this research study to find out the effect of t6 dermatomal electrical stimulation (delivered by a transcutaneous electrical nerve stimulation (tens) unit) on stomach motor activity.


Eligibility criteria:
inclusion criteria: 1. healthy volunteers with bmi ≤34.99 kg/m\^2 residing within 125 miles of mayo clinic in rochester, minnesota; these will be healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia on diet) disorders. 2. women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of the test day. 3. subjects must have the ability to provide informed consent before any trial-related activities. 4. eligible individuals will be asked to avoid taking additional medications and supplements for one week before and after the test day, unless reviewed and approved by the study team. exclusion criteria: 1. abdominal surgery other than appendectomy, caesarian section or tubal ligation. 2. positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility. 3. positive history of spinal cord injury and/or chronic back pain. 4. significant untreated psychiatric dysfunction based upon screening with the hospital anxiety and depression inventory (had). if such a dysfunction is identified by a had score \>11 on either anxiety or depression or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. 5. intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. exceptions are birth control pill, estrogen replacement therapy, thyroxine replacement therapy, low dose analgesia or anti-inflammatory medications (acetaminophen and ibuprofen) and any medication administered for co-morbidities as long as they do not alter gastrointestinal motility. 6. subjects may also be excluded from participation for other factors at the discretion of the principal investigator.
highcycle: effect of acetazolamide on pulmonary artery pressure in women compared to men

Conditions: High Altitude

Summary: randomized clinical trial evaluating the effect of acetazolamide on pulmonary artery pressure in women compared to men travelling to 3600 m.


Eligibility criteria:
inclusion criteria: * healthy, non-smoking men and women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives). * bmi \>18 kg/m2 and \<30 kg/m2 * born, raised and currently living at altitudes \<1000 m * written informed consent * premenopausal women with an eumenorrheic cycle exclusion criteria: * other types of contraceptvies (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others) * pregnancy or nursing * anaemic (haemoglobin concentration \<10g/dl) * any altitude trip \<4 weks before the study * allergy to acetazolamide and other sulfonamides

Keywords: women hypoxia prevention acetazolamide echocardiography
lifestyle intervention for rheumatoid arthritis

Conditions: Lifestyle Risk Reduction; Rheumatoid Arthritis

Summary: the main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating rheumatoid arthritis.

the main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating rheumatoid arthritis. if a lifestyle intervention is effective, we expect to see improvement in functional status and decreased health care costs to the study participant and the insurer.

Eligibility criteria:
inclusion criteria: 1. bcbsvt members who also carry the prescription benefit with bcbsvt (due to the need for tracking prescription costs). 2. bcbsvt membership for minimum of 12 months prior to start of study (due to the need for tracking prescription costs before and after intervention). 3. age 18 or older 4. medical diagnosis of ra exclusion criteria: 1. pregnancy 2. currently taking warfarin (since fluctuating amounts of green leafy vegetable intake can adversely affect inr levels and because we will be asking participants to increase the amount of green leafy vegetables they consume) 3. malignancy currently undergoing treatment (with further planned treatment at the time of enrollment) since patients undergoing cancer treatment often need to stop ra medications in order to improve immune function, and thus could be a confounder. 4. food allergy (including reactions such as hives, wheezing, difficulty breathing, fainting, or anaphylaxis)
clinical evaluation of ultrashort-term heat inactivation of cytomegalovirus (cmv) containing raw breast milk to prevent cmv-infection of preterm infants

Conditions: Cytomegalovirus Infection; Preterm Infants

Summary: to evaluate, in a prospective multicenter study, ultrashort-term heat inactivation for the prevention of cytomegalovirus (cmv) transmission in preterm infants (\<32 weeks gestational age or \<1500 g birth weight) under clinical conditions. inactivation will be done only during the period of infectivity of breast milk, characterized by viral excretion strongly associated with subsequent infection, monitored by periodic virologic examinations of bm and urine of the infant. thus the investigators hypothesis is that no cmv transmission through breast milk will occur using a gentle ultrashort heat inactivation procedure applied to infective breast milk. the protocol has been approved by the ethics committee of tuebingen university hospital.


Eligibility criteria:
inclusion criteria: * \<32 weeks or ga or \<1500g bw * mother cmv igg positive * breast milk feeding exclusion criteria: * parents disagree

Keywords: postnatal cmv infection of preterm infants breast milk
to evaluate the blockade of cgrp in preventing pacap-38 induced migraine-like attacks with amg 334 in migraine patients

Conditions: Migraine

Summary: phase i, randomized, parallel-group, double-blind, placebo-controlled, single dose study to evaluate the blockade of cgrp receptor by amg 334 in preventing pacap-38 induced migraine-like attacks in migraine patients.


Eligibility criteria:
inclusion criteria: * adults ≥ 18 to ≤ 45 years of age upon entry into screening * history of migraine headaches without aura for ≥ 6 months prior to screening according to the international headache society (ihs) international classification of headache disorders (ichd-ii) (headache classification committee of the international headache society, 2004) based on medical records and/or patient self-report * migraine frequency: ≥ 1 and ≤ 5 migraine days per month in each of the 3 months prior to screening exclusion criteria: * history of migraine with aura, cluster headache or hemiplegic migraine headache according to the ihs classification ichd-ii (headache classification committee of the international headache society, 2004) based on medical records and/or patient self-report * ≥ 6 migraine days per month in the last 3 months prior to study enrollment and during screening period * other headache disorders (except for episodic tension-type headache \<5 days/month)

Keywords: migraine headache migraine headache headache, migraine amgen
igev followed by autologous transplantation for refractory or relapsed hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: the aim of study is to prove igev regimen followed by autologous stem cell transplantation as salvage treatment in patients with refractory or relapsed hodgkin lymphoma is effective.

the standard treatment in patients with refractory or relapsed hodgkin lymphoma is salvage chemotherapy followed by autologous transplantation for responsive patients. however, the standard of salvage chemotherapy remains uncertain. this study is to evaluate the efficacy and safety of igev regimen in a single-center basis.

Eligibility criteria:
inclusion criteria: * age range: 18-65 years old * histological confirmed refractory or relapsed hodgkin lymphoma * with at least one site of measurable disease according to iwc criteria * ecog performance status 0-1 * life expectancy of more than 3 months * bone marrow function: anc≧1.5×109/l, plt≧100×109/l, hb≧80g/l * liver function: total bilirubin, alt and ast \<1.5×unl * renal function: cr\<1.5×unl, ccr≧45ml/min * no contraindication for transplantation exclusion criteria: * no prior chemotherapy * with more than 2 lines of prior chemotherapy exposure * evidence of cns and bone marrow involvement * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * pregnant or lactating women * significant active infection

Keywords: hodgkin lymphoma chemotherapy igev autologous stem cell transplantation