Kornimate/medical-research-clean huggingface dataset:
diagnosis of alzheimer's disease using event related potentials

Conditions: Mild Cognitive Impairment

Summary: this study evaluates the use of an eeg device using event related potentials to help diagnose alzheimer's disease in the outpatient clinical setting.

the objective of this study is to improve the accuracy of diagnosis of alzheimer's disease in a clinic setting using an eeg device to measure event related potentials. this study will recruit patients who are being seen with a memory complaint or the first time. it will be prospective in nature. subjects will initially be evaluated by clinicians and then clinicians will fill out a rating questionnaire as to their level of certainty of various possible dementia diagnoses. then, during the testing portion of the study, subjects will return to have an eeg test completed measuring event related potentials during an acoustic oddball paradigm task. the eeg will be completed by a technician who has no knowledge of the subject's clinical diagnosis. after the eeg is performed, the data will be evaluated by the study clinician in a blinded fashion. the clinician will log the eeg results as being either consistent with alzheimer's disease or not. finally, there will be analysis of the initial clinical rating by clinicians in comparison to a given subject's eeg results and interpretation. this will allow determination as to whether or not the clinical diagnosis was in agreement or disagreement with the eeg data and interpretation. at this time point a second clinician rating questionnaire will be completed to assess the current level of confidence and diagnostic certainty in light of the now revealed eeg data in addition to clinical data. there will also be quantitative analysis of mri structural data regarding regional atrophy patterns as well as amyloid pet data for some of the participants which will act as a diagnostic gold standard. an additional aim of this study is to investigate patterns of impairment on memory testing in older adults who are malingering and reporting a memory impairment in the absence of a disorder. this aim will involve testing healthy older adults using eeg and also testing memory impaired older adults with ad and comparing the results, as well as comparing the two groups results on neuropsychologic measures of effort including the test of memory and malingering (tomm). impact/significance: this proposed study could allow for increased accuracy and diagnostic certainty of the correct diagnosis among memory impaired patients and could allow for the incorporation of a new clinical technique, eeg testing among memory impaired patients.

Eligibility criteria:
inclusion criteria: cohort 1: older adults with memory impairment: must have a physician or primary caregiver report of memory loss and must be between 50 and 100 years old. cohort 2: older adults who test normally on neuropsychologic testing and have no history of neurologic disorders. exclusion criteria: lack of reported memory loss by physician or primary caregiver who does not meet age limits.

Keywords: alzheimer's disease frontotemporal dementia lewy body dementia diagnosis
preoperative therapy in patients with stages ib, ii, iiia, and selected iiib patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: this trial is designed to study the role of docetaxel/gemcitabine, an active and relatively non-toxic combination in advanced nsclc. this study will help to better define optimal preoperative regimens for patients with resectable nsclc. since both of these drugs are potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may produce not only radio-sensitization, but also considerable antitumor efficacy.

upon determination of eligibility, patients will receive: pre-operative * docetaxel * gemcitabine post-operative * docetaxel * carboplatin * radiation therapy patients with stage ib and ii nsclc who achieved clear margins will not receive any further therapy. patients with incomplete resection, resection margins of a t3 tumor that are positive or close, stage iiia and iiib nsclc or disease judged unresectable after preoperative chemotherapy will receive postoperative treatment

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * histologically confirmed non-small cell lung cancer * must be operable candidate * clinical stage ib, ii, and select iii non-small cell lung cancer are eligible * measurable or evaluable disease * able to perform activities of daily living with minimal assistance * must be \> 18 years of age * adequate bone marrow, liver or kidney * no previous chemotherapy or radiation therapy for non-small cell lung cancer * moderate to severe peripheral neuropathy * understand the nature of this study and give written informed consent. exclusion criteria: you cannot participate in this study if any of the following apply to you: * stage iv disease * history of prior malignancy within five years * women who are pregnant or breast-feeding please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
hypoglycemia and the mineralocorticoid receptor

Conditions: Hypoglycemia

Summary: the purpose of this study is to look at whether blockade of the mineralocorticoid receptor will result in changes in the cardiovascular and inflammatory response to hypoglycemia.

the effect of ongoing hypoglycemia on cardiovascular autonomic function is unclear and the focus of this protocol. in our preliminary studies, the investigators demonstrated that baroreflex sensitivity is impaired during hypoglycemia in healthy individuals. treatment with eplerenone (200mg total administered in two doses in the 15 hours prior to the hypoglycemic clamp) prevented this impairment. the study is based on the overarching hypothesis that hypoglycemia leads to increases in aldosterone/mineralocorticoid receptor (mr) activity and increased cardiovascular injury. this study will address the following specific aims: to test the hypothesis that mr blockade will reduce the adverse effects of hypoglycemia on inflammation and on autonomic control of cardiovascular function. the investigators will determine the effects of hypoglycemia (50 mg/dl for 2.0 hours) on the blood inflammatory factor interleukin-6 levels, and on cardiovascular autonomic function (baroreflex sensitivity) in each subject under two conditions - pretreatment with mr blockade (eplerenone) and pretreatment with placebo.

Eligibility criteria:
inclusion criteria: * healthy volunteers * males and females age 18 to 40 years exclusion criteria: * pregnancy * lactation * menopause * any medical condition other than treated hypothyroidism. * alcoholism * active tobacco use * in all subjects, any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded. * use of medications other than physiological thyroxine replacement * serum potassium \>5.0 mmol/l * estimated glomerular filtration rate \< 60 ml/min
blood glucose response to meals of varying glycemic index in youth with type 1 & 2 diabetes

Conditions: Type 1 Diabetes; Type 2 Diabetes; Impaired Glucose Metabolism

Summary: research to date suggests that the selection of lower glycemic index foods, that is, foods provoking a slower, more sustained blood sugar response, may result in improved glycemic control in youth with diabetes. however, there is currently insufficient data to support practice recommendations. the purpose of this pilot study is to test the blood glucose response to low and high glycemic index meals in youth with diabetes using continuous blood glucose monitoring, and to determine whether the effect of glycemic index differs by regimen or diagnosis. in this pilot study up to 42 youth with type 1 diabetes or impaired glucose metabolism (elevated fasting glucose, insulin resistance, or type 2 diabetes) will participate in 5 days of continuous blood glucose monitoring during which they will receive both low and high glycemic index meals. children will be provided with 1 full day of low glycemic index meals and 1 full day of high glycemic index meals in a supervised setting in randomized order. each of these test days will be preceded by a standard evening meal and snack. continuous blood glucose monitoring will also be conducted during regular food intake ad libidum away from the clinic, as well as during one day of instructed low glycemic meals at home. all food intake, insulin, and blood glucose self-monitoring will be recorded. while in the clinic, measures of satiety and acceptability of the food will also be obtained. data analysis will include indices of blood glucose levels and variability.


Eligibility criteria:
inclusion criteria: * diagnosed with type 1 diabetes for a minimum of 1 year with insulin dose greater than or equal to 0.5 u/kg/day, or diagnosed with elevated fasting glucose, insulin resistance, or type 2 diabetes * age 7 to 16 exclusion criteria: * dietary restrictions that would preclude eating the study diet * comorbid chronic illness requiring daily medical management * comorbid major psychiatric diagnosis * non-english speaking/writing

Keywords: diabetes children adolescents diet glycemic index
rib microtia and the erector spinae plane (esp) block

Conditions: Microtia, Congenital; Microtia; Anesthesia, Local; Anesthesia

Summary: the erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. this study is being performed to assess the effectiveness of this technique in reducing post-operative pain scores and opiate requirements in pediatric and adult patients undergoing rib cartilage grafting surgeries.


Eligibility criteria:
inclusion criteria: * ages 2-17 * able to consent (if greater than 7 years) and have parental consent * pediatric patients undergoing rib cartilage resection surgeries exclusion criteria: * participants who do not consent or have parental consent * patients who are clinically unstable or requires urgent/emergent intervention

Keywords: erector spinae plane erector spiane plane block rib cartilage
the validity and reliability of the turkish version of tasc and the relationship between smc and motor functions

Conditions: Cerebral Palsy, Spastic; Cerebral Palsy; Cerebral Palsy Spastic Diplegia; Cerebral Palsy Quadriplegic; Cerebral Palsy, Monoplegic

Summary: selective motor control (smc) impairment in children with cerebral palsy (cp) includes movement patterns dominated by flexor or extensor synergy affecting functional movements. the research was designed to investigate the validity and the reliability of the turkish version of the test of arm selective control (tasc) (which is improved to evaluate smc in children with spastic cp) and in order to provide more understanding of the relationship between smc and upper extremity and gross motor functions. the study included 21 hemiplegic, 11 diplegic and 4 quadriplegic children with cp whose ages are 4 to 18 years and gross motor function classification system (gmfcs) level changes from 1 to 4, and their parents. in order to evaluate the gross motor function of children, gmfcs and the ability to hold objects with their hands in daily activities were evaluated with manual ability classification system (macs). abilhand-kids scale was applied to evaluate upper extremity performance. tasc scale was used to evaluate the upper extremity smc of children.


Eligibility criteria:
inclusion criteria: * having a diagnosis of spastic cp * being able to understand the commands required for the test, * being between the ages of 3-18, * being gmfcs level i to iv. exclusion criteria: • having undergone orthopedic surgery or botulinum toxin a (btx-a) within the last 6 months

Keywords: cerebral palsy selective motor control upper limb upper limb functions gross motor functions
genistein in treating patients with stage ii, stage iii, or stage iv prostate cancer

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: randomized phase i trial to determine the effectiveness of genistein in treating patients who have stage ii, stage iii, or stage iv prostate cancer.

objectives: i. determine the safety and pharmacokinetics of genistein in patients with stage ii, iii, or iv prostate cancer. outline: this is a randomized, double blind, placebo controlled study. patients are randomized to one of two treatment arms. arm i: patients receive oral genistein twice daily. arm ii: patients receive oral placebo twice daily. treatment continues for 3 months in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 24 patients will be accrued for this study within 6 months.

Eligibility criteria:
disease characteristics: histologically confirmed stage b, c, or d adenocarcinoma of the prostate not amenable to surgery patient characteristics: age: 40 and over performance status: ecog 0-2 life expectancy: at least 6 months hematopoietic: wbc at least 3,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 2.0 mg/dl transaminases less than 4 times upper limit of normal renal: creatinine less than 2.0 mg/dl cardiovascular: no new york heart association class iii or iv heart disease other: no significant abnormalities of internal organs, neurologic status, or biochemical levels no history of seizures no concurrent serious illness no acute infection requiring antibiotic therapy except chronic urinary tract infection no other prior or concurrent malignancy within the past 2 years except nonmelanoma carcinoma of the skin no history of substance abuse or addiction no alcohol intake greater than 2 drinks/day or 14 drinks/week no diet containing more than 20 mg of genistein/day no known soy intolerance no prior breast cancer prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: at least 3 months since prior hormonal therapy or no concurrent estrogen other concurrent hormonal therapy allowed if stable regimen for more than 3 months radiotherapy: at least 4 weeks since prior radiotherapy and recovered surgery: see disease characteristics at least 3 weeks since prior surgery and recovered other: at least 6 weeks since prior antibiotics no concurrent genotoxicity therapy

Keywords: adenocarcinoma of the prostate stage ii prostate cancer stage iii prostate cancer stage iv prostate cancer recurrent prostate cancer
relative bioavailability study in healthy subjects comparing 2 dry powder oral suspensions of rivaroxaban under fasting and 20 mg of an oral suspension of rivaroxaban under fed conditions to 10 mg of an immediate release tablet under fasting conditions

Conditions: Pharmacokinetics

Summary: rivaroxaban is a substance developed for use in the treatment of blood coagulation disorders.thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood vessels. excessive coagulation activity can occur in children as well, and rivaroxaban is therefore being developed for the treatment of thromboembolic events in children and adolescents. as small children are often unable to swallow tablets, an oral suspension (mixture of a liquid containing finely distributed solids) has been developed which allows dosing according to body weight.the objective of this trial is to compare the bioavailability (proportion of a substance that remains available unchanged in the blood circulation) of a new oral suspension of rivaroxaban with a previously used oral suspension and with a rivaroxaban tablet approved for treatment. in order to evaluate the potential influence of food, the new oral suspension containing 20 mg rivaroxaban will be taken after consuming food. in addition, the pharmacokinetics (concentrations of the drug and breakdown products (metabolites) in blood), safety and tolerability will be assessed.


Eligibility criteria:
inclusion criteria: * healthy male subjects * age: 18 to 55 years (inclusive) at the first screening examination * white * body mass index (bmi): ≥18.0 and ≤29.9 kg/m2 at the screening visit. exclusion criteria * incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal * known coagulation disorders (e.g. von willebrand's disease, hemophilia) * known disorders with increased bleeding risk (e.g. periodontosis, hemorrhoids, acute gastritis, peptic ulcer) * known sensitivity to common causes of bleeding (e.g. nasal) * regular use of medicines and use of medication that may have an impact on the study objectives * clinically relevant findings in the ecg such as a second- or third-degree av block, prolongation of the qrs complex over 120 msec or of the qtc-interval over 450 msec * clinically relevant findings in the physical examination * clinically relevant deviations of the screened laboratory parameters from reference ranges * participation in another clinical study during the preceding 3 months (last treatment from previous study to first treatment of new study)

Keywords: biological availability relative bioavailability trial
a study of abt-414 in subjects with solid tumors

Conditions: Squamous Cell Tumors

Summary: a study of abt-414 in subjects with solid tumors.


Eligibility criteria:
inclusion criteria: 1. subjects must have a solid tumor type likely to over-express epidermal growth factor receptor (egfr) (phase 1) 2. subjects have an eastern cooperative oncology group (ecog) performance status of 0-2 3. subjects have available tumor tissue 4. subjects have adequate bone marrow, renal, and hepatic function as follows: bone marrow: absolute neutrophil count (anc) \>/= 1,500/mm3 platelets \>/= 100,000/mm3; hemoglobin \>/= 9.0 g/dl renal function: serum creatinine \</= 1.5 times the upper limit of the institution's normal range hepatic function: bilirubin, aspartate aminotransferase (ast), and alanine aminotransferase (alt) \</= 1.5 times the upper limit of the institution's normal range. subjects with liver metastasis may have an ast and alt of \</= 5.0 x the upper limit of normal. 5. subjects in the phase 2 portion must have squamous cell non-small cell lung cancer (nsclc) 6. eligibility is restricted to subjects with confirmed egfr amplification in the egfr amplified cohort exclusion criteria: 1. the subject has uncontrolled metastases to the central nervous system (cns). subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 28 days after definitive therapy and have not received prior whole brain radiation (phase 1 only). 2. the subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 28 days prior to the first dose of abt-414. 3. the subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any common terminology criteria for adverse events (ctcae) grade 2 or higher. 4. the subject had had major surgery within 28 days prior to the first dose of abt-414. 5. the subject has a history of immunologic reaction to any immunoglobulin g (igg) containing agent. 6. phase 2 portion only: the subject has previous or concurrent cancer that is distinct in primary site or histology from nsclc, except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. any cancer curatively treated greater than 3 years prior to entry is permitted.
buprenorphine transdermal system (btds) in subjects w/mod-sev osteoarthritis (oa) chronic pain of knee

Conditions: Chronic Pain; Osteoarthritis of the Knee

Summary: the objective of this study is to determine the analgesic efficacy and safety of buprenorphine transdermal system (btds) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (oa) of the knee. the double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. btds is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Eligibility criteria:
inclusion criteria: * subjects with moderate to severe chronic osteoarthritis (oa) pain of the knee (lasting several hours daily) as their predominant pain condition, * clinical diagnosis of oa of the knee 1 year or longer, * subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of \< 5 mg oxycodone (or equivalent) per day, * subjects whose oa knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy. exclusion criteria: * subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study, * subjects who are allergic to buprenorphine or who have a history of allergies to other opioids, * subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives. other protocol-specific inclusion/exclusion criteria may apply.

Keywords: chronic pain, oa of the knee, opioid, transdermal
no during cpb in neonates to reduce risk of aki

Conditions: AKI; CHD - Congenital Heart Disease; Surgery

Summary: acute kidney injury (aki) following cardiac surgery for congenital heart defects (chd) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. the investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (cpb), may reduce the incidence of aki.


Eligibility criteria:
inclusion criteria: * all neonates (≤31 days) undergoing cardiac surgery with cpb for chd will be deemed eligible for enrollment. exclusion criteria: 1. failure to obtain informed consent from parent/guardian 2. clinical signs of preoperative persistent elevated pulmonary vascular resistance, 3. emergency surgery, 4. episode of cardiac arrest within 1 week before surgery, 5. recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for cpb), 6. use of inhaled no (ino) immediately prior to surgery, 7. structural renal abnormalities by ultrasound, 8. preoperative aki, 9. use of other investigational drugs, 10. weight less than \<2 kg, 11. gestational age \<36 weeks, 12. major extracardiac congenital anomalies, 13. non-english speakers.