Kornimate/medical-research-clean huggingface dataset:
pet imaging of cancer patients using 124i-puh71: a pilot study

Conditions: Non-Hodgkin's Lymphoma; Myeloma; Active Solid Malignancy

Summary: the purpose of this study is to see how a new drug, named puh71, accumulates in the different parts of the body \& inside tumors and how long puh71 lasts in the blood, when given to study participants in tiny amounts. the results of this study will help researchers (1) plan how they will use puh71 as an experimental new drug (at much-higher doses) for the treatment of cancer, in clinical trials; and (2) know whether puh71 might be used as a drug for detecting tumors with scanner machines.


Eligibility criteria:
inclusion criteria: * patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma (histology confirmed by mskcc department of pathology) * disease is measurable or evaluable as defined by recist (1.1 or original version) or other tumor response criteria from an mskcc irb-approved clinical research protocol. * this does not apply to patients with myeloproliferative neoplasm. the presence of active myeloproliferative neoplasm will be determined by applicable disease specific diagnostic criteria and patient assessment by the patient's oncologist and trial investigators (eg, manifestations of active mpn such as splenomegaly, abnormal blood counts, etc). * age between 18-90 * negative serum pregnancy test for females of childbearing age (11-55 years) and/or lack child-bearing potential * no breast-feeding exclusion criteria: * previous allergic reaction to contrast medium. * hypersensitivity to iodide products. * known hyperthyroidism hepatic: * bilirubin \> 1.5 x institutional upper limit of normal (uln) * ast/alt \>2.5 x uln * albumin \< 2 g/dl * ggt \> 2.5 x uln if alkaline phosphatase \> 2.5 x uln. renal: creatinine \>1.5 x uln or creatinine clearance \< 60 ml/min. * positive serum pregnancy test for females * acute major illness (e.g., infection, unstable cardiovascular condition, etc.)

Keywords: pet scan 124i-puh71 10-139
subclinical atherosclerosis in hiv-infected patients

Conditions: HIV Infections; Coronary Atherosclerosis

Summary: we will obtain data using multi-slice ct technology to detect subclinical coronary disease in the hiv population. determination of subclinical cardiovascular disease using noninvasive technology and elucidation of the associated risk factors will help to guide targeted therapy to prevent cardiovascular events in this patient population. we will investigate the prevalence of coronary plaque lesions and coronary artery calcifications in men and women with hiv disease as determined by 64-row multidetector computed tomography (mdct) and mdct coronary angiography in comparison to age-matched control subjects without hiv infection. we hypothesize that evidence of coronary artery calcification and coronary plaque lesions as seen by mdct will be present in individuals with hiv more than non-hiv control subjects of the same age. we also hypothesize the degree of atherosclerosis will be increased in hiv patients compared to control subjects. we will evaluate the metabolic and inflammatory factors associated with coronary artery disease in hiv-infected individuals. we hypothesize that traditional cardiac risk factors as well as metabolic and inflammatory changes associated with hiv and its treatment such as dyslipidemia, increased secretion of inflammatory markers, decreased adiponectin, increased insulin resistance and increased visceral fat may be associated with coronary artery disease in hiv-infected individuals.


Eligibility criteria:
inclusion criteria for hiv infected subjects arm: 1. men and women age 18-60 2. bmi 20-35 3. previously documented hiv disease for 5 years or longer either on stable highly active anti-retroviral therapy (haart) or not on haart. 4. no changes in antiretroviral regimen within the prior 3 months. inclusion criteria for non-hiv infected control subjects arm: 1. healthy men and women age 18-60 2. bmi 20-35 exclusion criteria for both arms: 1. previously diagnosed coronary artery disease, cerebrovascular disease, or peripheral vascular disease. 2. use of glucocorticoids, growth hormone, testosterone, or other anabolic agents within past 6 months 3. renal disease or creatinine \>1.5 mg/dl 4. anti-inflammatory medications 5. opportunistic infection within past 6 months in hiv infected individuals and current acute infectious illness in both hiv-infected subjects and normal controls. 6. nitrates or others medications that can alter endothelial function 7. contraindication to beta-blocker use 8. body weight greater than 300 lbs due to dexa scanner table limitations 9. patients with previous allergic reactions to iodine-containing contrast media or to iodine will be excluded from participation 10. active illicit drug use 11. pregnancy or breastfeeding 12. estrogen or progestin use

Keywords: hiv atherosclerosis
mri-guided stereotactic body radiotherapy (sbrt) with simultaneous integrated boost for prostate cancer

Conditions: Prostate Cancer

Summary: radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). doses ranging from 35-45 gy in 5 fractions have demonstrated good outcomes with acceptable toxicity.

prostate sbrt is a standard of care treatment for prostate cancer that has not spread to distant metastatic sites. radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). doses ranging from 35-45 gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. in this initial study, mri guided treatment planning and delivery will be used to deliver 7 gy to the entire prostate and seminal vesicles, with a selective boost of additional 0.5, 1.0, 1.5, or 2 gy per fraction for a total dose of 37.5, 40, 42.5 or 45 gy to biopsy-proven lesions, defined using mri. hypothesis: mri-guided treatment planning and delivery can selectively target high-risk prostate nodules and deliver a higher radiation dose, to achieve maximal local control without increasing treatment toxicity

Eligibility criteria:
inclusion criteria: 1. biopsy-proven diagnosis of prostate adenocarcinoma 2. nccn defined low-, intermediate- and high-risk prostate cancer 3. age ≥ 18 4. patient must have prostate mri with a pirads 3-5 lesion or psma positron emission tomography (pet) with an avid intraprostatic lesion exclusion criteria: 1. history of prior pelvic radiation (external beam or brachytherapy) 2. inability to undergo mri 3. patients with metastatic disease (other than pelvic lymph nodes) are ineligible for this study 4. american urological association (aua) score \>17 - aua score \>17
prospective influence of bedtime insulin glargine on mobilization and function of endothelial progenitor cells

Conditions: Type 2 Diabetes

Summary: in this trial, it will be studied whether early addition of the long acting insulin analogue glargine is capable of increasing the number and differentiation of endothelial progenitor cells (epc) in patients with type 2 diabetes, which can be seen as a marker of vascular regenerative potential and cardiovascular risk. in addition, the effect of glargine on microvascular function will be studied. this will be done using laser doppler measurements of the skin; in addition, mri of the heart will be performed which is capable of quantifying the perfusion reserve of the myocardium and additional functional aspects of ventricular function. a beneficial effect of early addition of bedtime glargine on epc and vascular as well as myocardial function in this study might argue for a change in the therapeutic approach in type 2 diabetes and possibly improve the cardiovascular outcome in patients affected.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * oral antidiabetic therapy * age 35 - 70 * 6,5%\< hba1c ≤ 9% * ability of subject to understand character and individual consequences of clinical trial * written informed consent must be available before enrollment in the trial * for women with childbearing potential, adequate contraception (pearl index \< 1%, e.g. birth control pill) and negative blood pregnancy test * 6,5%\< hba1c ≤ 9% * ability of subject to understand character and individual consequences of clinical trial * written informed consent must be available before enrollment in the trial * for women with childbearing potential, adequate contraception (pearl index \< 1%, e.g. birth control pill) and negative blood pregnancy test exclusion criteria: * mody * malignant disease * hematopoietic disorders * impairment of renal function (serum creatinine \> 1,5mg/dl) * autoimmune disease * treatment with immunosuppressive drugs * psychiatric disease * myocardial ischemia during previous 6 month * acute coronary syndrome * pavk iib, iii, iv (fontaine-ratschow) * erythropoietin treatment * glitazone treatment during two weeks before inclusion * insulin treatment during two weeks before inclusion * pregnancy and lactation * history of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product * participation in other clinical trials and observation period of competing trials, respectively * no subject will be allowed to enroll in this trial more than once.
mindfulness-associated brain changes in adults with autism

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study to measure brain functioning before and after stress-reduction classes to better understand how symptom improvements relate to brain functioning in adults with asd (autism spectrum disorder). participants will be randomly assigned to one of two stress reduction classes that will meet once a week for 8 weeks. one group will complete a structured training program called mindfulness based stress reduction (mbsr) that involves teaching about increased mindfulness strategies and gentle stretching. the other group will review relaxation techniques and other stress reduction strategies and will include social support. structural and functional mri, eeg, and behavioral self-report data will be collected to understand more about how the brain changes in subtle ways when people feel better and are more aware of their emotional state.


Eligibility criteria:
inclusion criteria: * age 18 to 89 years old, with a special focus on adults with asd who are going to college given the additional stress of this phase in life. we are recruiting participants across a broad age range in order to maximize our ability to inform interventions for adults with asd. the upper age limit of 89 years was selected so a de-identified dataset can be created with all participant ages included. * asd diagnosis via gold-standard diagnostic assessments (autism diagnostic observation schedule-2). * must be able to attend at least 7 of the 8 weekly intervention classes. * english speaking: participants must be english-speaking because the screening and behavioral measures are in english (including the intelligence estimate). exclusion criteria: * participants with intelligence quotient (iq) scores \<70 will be excluded to minimize variability due to general cognitive functioning. * report of any major medical illnesses, histories of seizures, or head trauma with loss of consciousness. these health factors can cause brain changes that would confound findings. * concerns that the participant may not be able to complete the mri neuroimaging requirements for the study, including claustrophobia or metal objects within the participant's body or eyes. implanted metal objects may create a safety hazard in the powerful magnetic field during mri imaging. * pregnant women. mri has no known effects on pregnancy or fertility. however, since we are not 100% certain mri has no effects on a developing fetus, women who are pregnant may not participate in this study.
a study of atezolizumab (tecentriq®) in ministry of food and drug safety (mfds)-approved indication(s)

Conditions: Urothelial Carcinoma; Carcinoma, Non-Small Cell Lung; Small Cell Lung Carcinoma; Triple Negative Breast Carcinoma; Hepatocellular Carcinoma

Summary: this phase 4, prospective, multicenter, non-interventional, regulatory post-marketing surveillance study will collect information on the the safety and effectiveness of atezolizumab under the clinical practice, and update the drug label approved by the mfds in korea.


Eligibility criteria:
inclusion criteria: * participants who are administered with atezolizumab for the locally approved indications exclusion criteria: * participants with a known hypersensitivity to atezolizumab or to any of the excipients
neurokinin receptor antagonist associated to ondansetron in ponv

Conditions: Postoperative Nausea and Vomiting

Summary: the purpose of this study is to determine whether patients at high risk for postoperative nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the perioperative period.

high risk surgical patients for ponv, scheduled for laparoscopic surgery will be distributed in two groups: group i will receive aprepitant 80 mg per os and group ii will receive placebo per os, one hour before surgery. in the operating room, patients will be submitted to combined intravenous general anesthesia plus spinal anesthesia. all patients will receive dexamethasone 4 mg and ondansetron 4 mg intravenously during the surgical procedure. after surgery, patients will be monitored for pain, nausea and vomiting during 24 hours.

Eligibility criteria:
inclusion criteria: * high risk patients for nausea and vomiting exclusion criteria: * cardiovascular disease, or hypersensibility to any of the drugs involved in the study

Keywords: nausea, postoperative postoperative nausea postoperative vomiting vomiting, postoperative
correlation between postoperative cognitive-related adverse reactions and brain metabolomic characteristics in elderly patients

Conditions: POCD - Postoperative Cognitive Dysfunction

Summary: postoperative cognitive dysfunction (pocd) refers to the difficulties of orientation, cognition, communication, memory and abstract thinking of patients after anesthesia and surgery. and/or accompanied by the decline of the ability in social activities, such as the change of personality, social ability of language and behavior, cognitive function and life skills. pocd is a common complication of central nervous system in elderly patients after operation, with an early incidence of about 21% and a long-term incidence of about 35% . according to the current research on alzheimer's disease (ad) and pocd in the elderly, it has been found that they have similar pathological basis and some homologous related genes. altogether, pocd is closely related to molecular pathway neuropsychiatric diseases (such as dementia, depression and alzheimer's disease). researchers have come up with various hypotheses to reveal the underlying mechanisms of pocd, including neuritis, oxidative stress, autophagy disorder, synaptic dysfunction, and lack of neurotrophic support. to date, apart from evaluating with scales, ct scan and eeg analysis, there is neither exact biomarkers for monitoring and diagnosing pocd, nor clear relationships between specific brain metabolomic characteristics, eeg changes and diagnosis of pocd, so that the diagnosis of early pocd only stays in the evaluation of clinical symptoms and scales. therefore, our study aims to provide an effective basis for early diagnosis and treatment of clinical pocd through multivariate analyses of clinical scales combined with brain metabolomic characteristics, eeg analysis of patients.


Eligibility criteria:
inclusion criteria: * 65 years or older . * complete the operation in our hospital * asa classification i-ii level * agree to participate in this research and agree to sign an informed consent form exclusion criteria: * history of preoperative psychosis and psychotropic drug use * the subject is diagnosed with ad; * abnormal preoperative mental scale assessment * have a history of emergency rescue during the perioperative period * metal implants * postoperative immobilization patients
effect of treatment bi 1744 cl (5 and 10 mcg) versus placebo on exercise endurance time during constant work rate cycle ergometry ii

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to compare the effects of bi 1744 cl versus placebo on exercise tolerance after 6 weeks of treatment in patients with chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to participation. 2. diagnosis of chronic obstructive pulmonary disease and post-bronchodilator fev1(forced expiratory volume in 1 sec) \<80% of predicted normal and post-bronchodilator fev1(forced expiratory volume in 1 sec)/fvc of \< 70% at visit 1. 3. male or female between 40 and 75 years of age. 4. current or ex-smokers with smoking history of more than 10-pack years. 5. able to perform technically acceptable pulmonary function tests, multiple exercise tests and able to maintain records. 6. able to inhale medication in a competent manner from a metered-dose inhaler and respimat inhaler. exclusion criteria: 1. patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an sgot \>x2 uln, sgpt \>x2 uln, bilirubin \>x2 uln or creatinine \>x2 uln. 2. patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3. 3. patients with thyrotoxicosis, paroxysmal tachycardia (\>100 beats per minute). 4. patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse or contraindications to exercise. 5. patients who have undergone thoracotomy with pulmonary resection. 6. patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. 7. patients who regularly use daytime oxygen for more than one hour per day. 8. patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program. 9. patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea. 10. pregnant or nursing women. 11. women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
effectiveness of atkins diet for weight loss

Conditions: Obesity

Summary: dr. atkins' new diet revolution has sold over 10 million copies and has been on the new york times best seller list for 158 weeks. this and other low-carbohydrate diets, such as the zone, sugar busters, and the carbohydrate addicts diet, have attracted much popular attention but little scientific evaluation. given the widespread use of these diets, it seems prudent to evaluate them both for safety and efficacy. therefore, the purpose of the study is to compare the effectiveness of two different weight control programs over the course of 52 weeks. these two programs are 1) the atkins' new diet revolution, a low-carbohydrate, high-protein diet, and 2) brownell's learn program, a high carbohydrate, low fat diet based on behavior modification. specifically, this study will compare short-term changes in weight, food intake, blood chemistries and mood in adult males (n=10) and females (n=10) who are randomized to either the atkins' diet or the learn program for a period of one year. during this year, they will be under medical supervision. we will examine the effect of the two weight loss plans on changes in lipids, blood pressure, insulin sensitivity and ketones, and eating behavior. this is a feasibility study and thus the data will ultimately be used to design a large randomized trial with adequate statistical power.


Eligibility criteria:
- bmi 25-40 kg/m2 inclusive
clinical evaluation of iron treatment efficiency among non-anemic but iron-deficient female blood donors

Conditions: Fatigue; Iron Deficiency

Summary: the purpose of this study is to determine the subjective response of iron substitution (tardyferon®) on fatigue in women blood donors with a mean serum ferritin \< 30ng/ml and to assess variation of ferritin and hemoglobin after a blood donation.

* actually, there's no recommendation to check ferritin level in blood donors, even if several studies pointed out the high prevalence of iron deficiency after a blood donation. furthermore, some clinical trials showed that non-anaemic women with unexplained fatigue may benefit from iron supplementation. * the purpose of this study is to determine the subjective response of iron substitution (tardyferon®) on fatigue in women blood donors with a mean serum ferritin \< 30ng/ml and to assess variation of ferritin and hemoglobin after a blood donation. * we will measure blood count, ferritin level and c-reactive protein at the time of the blood donation and then after a week, a month and 3 months. a week after the blood donation, donors with a ferritin level \ 120g/l (non anaemic) will be included in the study and randomised. a one-month iron treatment vs placebo will be introduced. to assess the subjective response on fatigue, the donors will fill in different questionnaires at the time of the blood donation and then after a week, a month and 3 months.

Eligibility criteria:
inclusion criteria: * women * aged 18 - 50 * eligible for a blood donation exclusion criteria: * men * age below 18 or above 50 * not eligible for a blood donation (according to the blood donation eligibility guidelines of the swiss red cross) * hemochromatosis, psychiatric / thyroid / hepatic / rheumatismal / kidney or cardiopulmonary diseases that can cause fatigue * intestinal disease or medical treatment that can perturb iron absorption and/or excretion * donors with mental disorder or psychiatric disease that are unable to give consent * acute or chronic inflammation * diabetes and pregnancy

Keywords: fatigue blood donation iron deficiency ferrous sulphate donation donors iron ferritin hemoglobin anemia anaemia haemoglobin don women blood donors