Kornimate/medical-research-clean huggingface dataset:
prospective randomized trial on radiation dose estimates of ct angiography in patients scanned with a 100kv protocol

Conditions: Coronary Disease

Summary: the objective of this study is to compare radiation dose of a 100kv scan protocol to the standard 120kv scan protocol. we hypothesize that the 100kv scan protocol is associated with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not inferior. secondary endpoints of the study include quantitative image quality parameters, diagnostic accuracy for 120 vs.100kv studies compared to invasive angiography in patients who underwent subsequent invasive coronary angiography

all patients scheduled for a coronary ct scan are screened for inclusion and exclusion criteria. patients are included if they have stable sinus rhythm (heart rate \<100 bpm) and a body weight \< 90 kg or a body mass index (bmi) \< 30. informed signed consent is obtained from these patients and the ct scan is prepared. after topogram scan and the native scan for ca-scoring, patients are randomized in two groups with the use of sealed envelopes. after that contrast-enhanced coronary ct angiography is performed with the 120kv- or 100kv-protocol. the ct examination is evaluated by two experienced investigators on a per-vessel basis and all results and study-related data are collected in a dedicated database. for assessment of image quality, a previously established 4-point score system is used and quantitative image quality parameters are measured. a 30 day follow-up after the ct examination aims to evaluate if patients underwent invasive coronary angiography or were scheduled for a myocardial stress / perfusion test (such as stress-echocardiography, myocardial scintigraphy or stress perfusion imaging by mri).

Eligibility criteria:
inclusion criteria: * patients with an indication for a coronary ct angiography (planned evaluation of the coronary arteries) * stable sinus rhythm * patient weight \< 90kg or body mass index \< 30 kg/m2 * signed informed consent exclusion criteria: * non-ecg triggered studies * non-coronary cta studies, e.g. bypass graft ctas, pre- or post ep studies, cabg planning studies

Keywords: coronary ct angiography radiation dose estimates
safety and efficacy study of intracranially implanted carmustine to treat newly diagnosed malignant glioma

Conditions: Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Anaplastic Oligoastrocytoma; Glioblastoma

Summary: the purpose of the study is to determine the safety and efficacy of intracranially implanted carmustine in the treatment of patients with primary malignant glioma.

malignant gliomas recur mostly 2 cm within originated area. local therapies therefore become particular important. gliadel wafer developed in the states and marketed in the developed countries is an example of such treatments. the product in this study, carmustine sustained release implant (casant), is similar to that of gliadel wafer as for the api(active pharmaceutical ingredient), but different as for drug delivering system. as required, the preliminary clinical studies were conducted in china. based on the results of phase i/ii , 8-10 wafers containing given dose of bcnu will be administered intracranially in this phase iii to the tumor resected cavity to investigate the safety and efficacy in the treatment of primary malignant glioma in 236 patients.

Eligibility criteria:
inclusion criteria: * confirmation of high grade glioma(who iii or above)by frozen or squash preparation; * patients must be 18 to 70 years old, signed icf; * at least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas); * kps ≥ 60; * unilateral, supratentorial, solitary lesion and not crossing the midline * no obvious important organ dysfunction: hepatic function:serum total bilirubin ≤1.5 times upper limit of laboratory normal; aspartate aminotransferase (ast) and/or alanine aminotransferase (alt)\<2.5 times upper limit of laboratory normal; renal function:serum creatinine ≤1.5 times upper limit of laboratory normal; * not pregnant or lactating for women of childbearing potential. exclusion criteria: * underwent cytoreductive surgery(excluded stereotactic biopsy); * with chemotherapy or brain radiotherapy history; * tumor located at ventricular system, open ventricle tumor cavity postoperatively; * concomitant with other life-threatening diseases and with life expectancy \<12 months; * allergic to nitrosourea drugs; * with history of intracranial radiotherapy or implant chemotherapy; * with serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control; * experienced \> 3 times of large epilepsy within one month preoperatively. * investigators thought unsuitable for enrollment.
neuropattern - assessment of a translational diagnostic tool for depression, adjustment- and somatoform-disorders

Conditions: Major Depression; Minor Depression; Somatoform Disorders; Adjustment Disorders

Summary: neuropattern is a first translational tool in stress medicine. neuropattern is a diagnostic tool, which can be applied by in- and outpatients and physicians to detect dysregulation in the stress response network. the physician provides anamnestic and anthropometric data, while the patient takes other measures at home, e.g. psychological, symptomatic, and biological data. among the biological data are ecg measures for analyses of heart rate variability, and salivary cortisol measures before and after a dexamethasone challenge test. all data are analyzed in a central laboratory, which generates a written report for the physician, including a disease model, from which personalized recommendations for pharmacological and psychological treatments are derived. neuropattern additionally offers individualized internet modules to inform the patient about the disease model and to teach him/her what he/she can do to improve his/her medical conditions. the current study applies neuropattern in 2000 patients of family doctors, suffering from major depression, depressive episodes, adjustment disorders, and somatoform disorders. the patients receive either unspecific or individualized internet modules in a randomized order.


Eligibility criteria:
inclusion criteria: * native speakers * icd-f diagnoses 32, 33, 43.2, and 45 exclusion criteria: * patients under glucocorticoid treatment * patients taking antidepressants and anxiolytics * patients under psychotherapeutic treatment * pregnant women * severe medical conditions * mental retardation * arrhythmia absoluta * intolerance of dexamethasone
fetal thyroid ultrasound and fetal thyroid hormones

Conditions: Pregnancy Complicated by Hyperthyroidism; Hypothyroidism in Pregnancy

Summary: non invasive methods: maternal antithyroid antibodies and ultrasound measurement of the fetal thyroid gland could be an important tool for detecting fetal thyroid dysfunction in mothers with autoimmune thyroid disease.

autoimmune thyroid disease complicates 5-20% unselected pregnancies. the crucial impacting factor on the pregnancy outcomes in mothers with autoimmune thyroid disease is the thyroxine level changes. but, fetal hypo or hyperthyroidism can be found in treated pregnant women with autoimmune thyroid disease, even when their thyroid hormones are in normal range, because thyroid antibodies, antithyroid drugs and iodine pass the placenta. our previous results show that high fetal free thyroxine (ft4) levels measured by cordocentesis are unexpectedly frequent in women with autoimmune thyroid disease, including maternal autoimmune hypo- and hyperthyroidism. increasing awareness that even some mild fetal disorder can have an impact on later neurophysiologic development and the health of an individual makes the recognition and therapy of fetal hypo- or hyperthyroidism an increasingly significant domain of interest. according to our results, fetal ft4 concentrations did not correlate neither with dose of medication nor with ultrasound biometric parameters; the range for maternal thyroid-stimulating hormone (tsh) correlated predominantly with normal ft4 can not be marked off. the type and concentration of antithyroid antibodies might have some prognostic value. there is a growing list of publications referring to the ultrasound measurement of the fetal thyroid as an important tool for detecting fetal thyroid dysfunction. fetal thyroid measurement became a part of the clinical guidelines for pregnancies complicated with maternal thyroid disease.

Eligibility criteria:
inclusion criteria: * pregnant women diagnosed and treated for autoimmune hyper or hypothyroidism: - disease diagnosed by an endocrinologist, based on clinical and laboratory tests and ultrasound thyroid examination. * all of the hyper or hypothyroid women have to be positive for one or both thyroid antibodies when entering the study. * patients with autoimmune thyroid disease will be included into the study in the first half of pregnancy, but not later than 20th weeks of gestation * for the pregnant women in control group: * if they are euthyroid, with antithyroid antibodies within reference range, healthy and have uncomplicated pregnancy exclusion criteria: * patients with chronic diseases (except for thyroid disease) in their past medical history record. pregnancy induced diseases are not a part of the exclusion criteria (gestational diabetes and pregnancy induced hypertension) * all the patients whose pregnancies resulted from assisted reproductive technologies will be excluded from the study. * mothers from the control group will be excluded, if the neonate have abnormal thyroid function

Keywords: fetal thyroid ultrasound fetal ft4 antithyroid antibodies pregnancy autoimmune thyroid disease
validation of a screening tool to assess dehydration in hospitalized older population

Conditions: Dehydration Hypertonic; Aged

Summary: the study aims to verify the sensitivity and specificity of a tool to assess the state of hydration of the older person to identify those at risk of dehydration.

dehydration is the result of insufficient ﬂuid intake and can be consequent to an alteration of thirst mechanisms or ﬂuid loss from the intestinal and respiratory tracts. the use of diuretics can lead to dehydration too. the risk of dehydration induced by acute or chronical diseases is increased in older people because of the reduced capacity to maintain a proper fluid balance. lower muscle mass, reduced kidney function, physical and cognitive disabilities, blunted thirst, and polytherapy are recognized as main factors for dehydration risk in older people.for these reasons, coordinated efforts are necessary to develop comprehensive assessment tool to monitor hydration in hospitalised older adults. we need to develop a pathway of screening to detect early stage dehydration in older patients in order to correct it precociously. presently, no standardized clinical dehydration assessment method exists and there are relatively few papers investigating hydration status. a new tool was created: the geriatric dehydration screening tool - modified doesn't require laboratory parameters, and thus its use is feasible outside hospital settings. the aim of this study is to evaluate the diagnostic accuracy of the geriatric dehydration screening tool - modified in the assessment of the hydration status of hospitalized older population.

Eligibility criteria:
inclusion criteria: * complete blood tests: urea, glucose, sodium, potassium reported not more than 24 hours before the observation; * absence of known cognitive impairments (mini-mental state examination \> 24). exclusion criteria: * age \< 65; * mini-mental state examination \< 24.

Keywords: screening tool
preoperative exercise in pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to investigate the effects of a preoperative exercise program in patients with pancreatic cancer preparing for surgery. preoperative exercise programs have been shown to be effective in other cancer populations, but have not been investigated in patients with pancreatic cancer. the outcomes in this study will be changes in physical fitness, function, and postoperative outcomes. this investigation is a non-randomized control trial, with participants assigned to receive the preoperative exercise intervention in addition to standard care, or standard care alone if unable to commit to an exercise program for practical reasons. possible mediators for the effects of exercise on postoperative outcomes will also be assessed, including psychological outcomes and markers of systemic inflammation. these measures will be assessed in all participants prior to program initiation, prior to surgery, and after surgery. changes in these measures in response to exercise will be assessed, as well as the ability of the preoperative measures to predict postoperative outcomes.

this study focuses on patients prescribed neoadjuvant (preoperative chemotherapy and radiation) prior to surgery for borderline resectable pancreatic adenocarcinoma. this allows for a known, preoperative window long enough to provide an effective exercise intervention. the exercise program will be administered for at least eight weeks, but has no cap on length, as neoadjuvent treatment periods can vary between participants and a cessation of the exercise program before the end of this period could result in an undesirable loss in physical fitness and function. the study is a non-randomized, parallel group, intervention control trial, based on pilot studies in similar patient populations. all participants meeting the inclusion criteria and able to participate in the exercise program will be assigned to the exercise group. participants meeting the inclusion criteria, but unable to commit to the exercise program for practical reasons (transportation, location, etc), will be assigned to the standard care group.

Eligibility criteria:
inclusion criteria: * recent (\< 4 week) first diagnosis of a borderline resectable pancreatic adenocarcinoma * prescription to receive neoadjuvant therapy and surgery, * age 21 to 80 years old, * physician clearance to participate in exercise program. exclusion criteria: * any significant comorbid conditions that would interfere with or preclude participation in an exercise intervention, including orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries * advanced rheumatoid arthritis * widespread chronic pain conditions such as fibromyalgia * pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, interstitial lung disease, use of supplementary oxygen * known cardiovascular disease or new cardiac event in last 6 months * diabetes * pregnancy * second cancer diagnosis at the time of enrollment

Keywords: exercise physical activity
acute and short-term chronic effects of galvus (vildagliptin) in diabetes type 2 obese women

Conditions: 1- Microvascular Function; 2-oxidative Stress; 3-inflammation

Summary: the prevalence of obesity and type 2 diabetes mellitus (t2dm) has increased progressively in the past decades, and consequently, a higher incidence of cardiovascular diseases is observed. as this process develops, the endothelial dysfunction is present at early stages of the atherosclerotic disease. studies conducted at biovasc/uerj show the occurrence of endothelial and microvascular dysfunction in obese carriers, even in the absence of dysglycemia. new concepts indicate the endothelium as a possible therapeutic target, and drugs which act not only on diabetes mellitus pathophysiology but also acting as direct cardiovascular protectors bring new therapeutic possibilities. the dipeptidyl-peptidase-4 inhibitors (dpp4), such as vildagliptin, are drugs used on the t2dm treatment. its incretin mimetic and insulinotropic effects are already well established and several other studies show its effectiveness in reducing glycated hemoglobin, even in monotherapy. currently, fat rich foods are being increasingly introduced in the western way of life and recent evidence suggests that the postprandial lipemia (lpp) is related to cardiovascular risk. a better glucose control using vildagliptin can reduce the oxidative stress, and consequently promote a better microvascular and endothelial reactivity. however, vildagliptin can have an additional cardiovascular protective action, not only because of its effect on glycemia and oxidative stress reduction, but maybe because of its direct effect on intestinal peptides with postprandial lipemia reduction. to test this hypothesis, we will proceed the following exams: venous occlusion pletysmography, nailfold videocapilaroscopy and laser-doppler flowmetry aiming to evaluate vascular reactivity on muscle and at cutaneous site. anoter group of patients with the same clinical charactherisitics will use metformin, in order to compare its effects with those obtained from the use of vildaglitpin. our purpose is to determine whether vildagliptin, evaluated in obese and diabetic women, has vascular protective effects, and whether the regulatory mechanisms of these actions correlate with oxidative stress, inflammatory markers and intestinal peptides in baseline state and after a lipid overload.


Eligibility criteria:
inclusion criteria: * all patients should have bmi \> 30kg/m² * present untreated diabetes mellitus type 2 * age between 19 and 50 years * waist circumference \> 80 cm exclusion criteria: * renal, coronary vascular or peripheral, hematologic or hepatic disease * presence of severe hypertriglyceridemia (\> 400mg/dl) * smokers * significant body mass loss (\> 5%) within the six months prior to the study

Keywords: endothelial function microvascular function incretins diabetes mellitus postprandial lipemia
the effectiveness of resistance training on glycemic control for patients with type 2 diabetes in cardiac rehabilitation

Conditions: Type 2 Diabetes (T2DM); Cardiovascular Disease

Summary: this study is designed to investigate the effect of a structured resistance training program on glycemic control, measured by hemoglobin a1c (glycated hemoglobin), in patients with type 2 diabetes (t2dm) who are enrolled in outpatient cardiac rehabilitation. the investigator will compare the experimental group receiving resistance training to a control group made of patients enrolled in outpatient cardiac rehabilitation and perform 3 aerobic exercise modalities during their sessions, which is the current standard of care.


Eligibility criteria:
inclusion criteria: * diagnosis with t2dm and have been accepted for a standard outpatient cardiac rehabilitation program * cognitively able to comprehend the information presented in the program * cognitively able to give informed consent to participate in this study exclusion criteria: * patients with orthopedic or neurological limitations that would prevent them from participating in the resistance training program or monitored exercise sessions.
highly active antiretroviral therapy (haart) adherence interventions

Conditions: HIV Infections

Summary: this study proposes a 4-armed factorial randomized clinical trial in nairobi, kenya to determine the effect of cognitive and behavioral interventions on haart adherence.

the study will be a prospective randomized clinical control trial among hiv-1 seropositive adult participants beginning haart (highly active antiretroviral therapy) for the first time. patients who are eligible to be initiated on haart at the uw/coptic hope center for infectious diseases will be referred for enrollment. eligible patients who are referred will learn about the study and be invited to enroll after signing a written informed consent. study participants will be randomized to one of four arms:educational counseling, a pocket alarm device, both education and alarm, or neither. participants will be followed in the study for 1 ½ years after enrollment and randomization. participants will return to clinic every month to pick up a renewal of their antiretroviral prescriptions at which time pill counts will be performed. during follow-up visits, blood will be drawn and stored for cd4 counts and hiv-1 viral analyses. within this trial, the study also proposes to identify sociodemographic and spatial correlates of adherence. the study hypothesizes that educational counseling and medication alarm devices may significantly improve adherence, and that poor adherence may be associated with low socioeconomic standing, increased mobility, and distance from clinic.

Eligibility criteria:
inclusion criteria: * individuals must qualify for haart treatment by world health organization (who) criteria (clinical stage iv disease) and/or cd4 count of less than 200 and plan to start haart therapy. * must be above 18 years of age * must be haart treatment-naïve * must agree to home visits, and plan to live in kenya for at least two years. exclusion criteria: * individuals who are mentally incompetent or are pregnant are excluded from the study.

Keywords: patient compliance
injection of autologous cd34-positive cells for critical limb ischemia

Conditions: Peripheral Artery Disease; Peripheral Vascular Disease; Critical Limb Ischemia

Summary: the purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with critical limb ischemia (cli).


Eligibility criteria:
inclusion criteria: * 21-80 years of age * moderate or high-risk critical limb ischemia (rutherford clinical severity score 4 or 5) * unsuitable for conventional revascularization exclusion criteria: * advanced cli (rutherford clinical severity score 6) characterized by extensive tissue loss or gangrene * advance av block or nyha class iii or class iv heart failure * myocardial infarction within 3 months of treatment * successful coronary or lower extremity revascularization within 3 months of study enrollment * arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder with the exception of thromboangitis obliterans (buerger's disease) * co-morbidity associated with life expectancy of less than 1 year

Keywords: pad pvd cli stem cells
osa in never smokers with lung cancer

Conditions: Lung Cancer; Obstructive Sleep Apnea

Summary: previous studies have yielded inconsistent findings regarding the association between obstructive sleep apnea and the prevalence and mortality of lung cancer. smoking history, a common risk factor for lung cancer, chronic obstructive pulmonary disease, and obstructive sleep apnea, may act as a confounding variable, limiting interpretation of the results. the aim of this study is to evaluate the prevalence of obstructive sleep apnea in never smokers with lung cancer and to determine the effect of obstructive sleep apnea on the prognosis of lung cancer. enrolled patients will undergo respiratory polygraphy before beginning treatment for lung cancer. this prospective cohort includes both cross sectional and longitudinal analyses.


Eligibility criteria:
inclusion criteria: - never smokers who are admitted to the seoul national university hospital and newly diagnosed with lung cancer, with ecog performance status 0 or 1 exclusion criteria: * patients who have received treatment for lung cancer before the enrollment * patients who have received treatment for osa before the enrollment * patients with an expected life expectancy of less than 3 months * patients with neuromuscular disease, chronic opioid medication use, or severe insomnia not controlled by medication * patients receiving supplemental oxygen therapy due to underlying diseases including heart failure, chronic obstructive pulmonary disease, interstitial pulmonary disease, hypoventilation syndrome, stroke, or whose baseline oxygen saturation is less than 90% * patients with unstable medical conditions within the preceding 3 months (hospitalization due to acute exacerbation of underlying lung disease, diagnosis of unstable angina or myocardial infarction, history of percutaneous coronary intervention or coronary artery bypass surgery, or diagnosis of transient ischemic attack or stroke) * patients with an inability or unwillingness to provide informed consent