Kornimate/medical-research-clean huggingface dataset:
congenital heart adolescents: program of transition evaluation research

Conditions: Congenital Heart Defects

Summary: the objective of this study is to evaluate the potential role of a cardiology clinic-based educational intervention for 15 to 17 year olds with congenital heart disease (chd) and their parents, and to determine whether this intervention results in improved self-management skills (e.g., renewing medication prescriptions), teens having greater knowledge of their heart condition, and more teen and parent satisfaction with services. the results of this study will form the basis for a website that in turn may serve as an additional means of providing transition interventions. the results of this study may also be applicable to youth with other special health care needs.


Eligibility criteria:
inclusion criteria: * age 15-17 * followed in the stollery pediatric cardiology clinic or the northern alberta adult congenital (naach) clinic * moderate or complex congenital heart disease (as defined by the 2001 bethesda guidelines) or acquired heart disease (cardiomyopathy (dilated, hypertrophic, or restrictive forms), marfan's syndrome or rheumatic heart disease with cardiac involvement) exclusion criteria: * developmental delay, reading level below grade 6 based on patient or parent report

Keywords: health care transition adolescent
evaluation of efficacy and safety of a combination containing myo-inositol, d-chiro-inositol, alpha-lactalbumin, zinc and extract of gymnema sylvestre in subjects diabetic patients.

Conditions: Type 2 Diabetes

Summary: mellitus type 2 diabetes (t2md) is a chronic disease characterized by high glucose plasmatic level due to an alteration of insulin function. several authors have correlated this altered function to an inositol depletion. the main present member of inositol family in biological systems is undoubtedly myo-inositol, a precursor of several second messengers, widely involved in insulin signalling. for this reason this molecule is considered an insulin-sensitizer. the high excretion of inositol in t2md patients is frequent, inducing a myo-inositol depleted state that favours the onset of insulin resistance, impairing the activity of this hormone. the aim of this study is to evaluate the efficacy and the safety of a food supplement containing myo-inositol in t2md patients.


Eligibility criteria:
inclusion criteria: * with diagnosis of type 2 mellitus diabetes for at least 1 year * levels of hb1ac ranging from 7.5% to 9.0% exclusion criteria: * patients that require insulin treatment * treated at baseline with food supplements or drugs containing myo-inositol, d-chiro-inositol, alphalactalbumin, zinc, or gymnema sylvestre; * any contraindications to the treatment or to any substance used for the treatment * subjects with intestinal malabsorption * patients subjected to surgery within 6 months before baseline; * chronic treatment with systemic corticosteroids

Keywords: type 2 diabetes myo-inositol gymnema sylvestre
deep learning for prostate segmentation

Conditions: Prostate Cancer

Summary: because the diagnostic criteria for prostate cancer are different in the peripheral and the transition zone, prostate segmentation is needed for any computer-aided diagnosis system aimed at characterizing prostate lesions on magnetic resonance (mr) images. manual segmentation is time consuming and may differ between radiologists with different expertise. we developed and trained a convolutional neural network algorithm for segmenting the whole prostate, the transition zone and the anterior fibromuscular stroma on t2-weighted images of 787 mris from an existing prospective radiological pathological correlation database containing prostate mri of patients treated by prostatectomy between 2008 and 2014 (clara-p database). the purpose of this study is to validate this algorithm on an independent cohort of patients.


Eligibility criteria:
inclusion criteria: * prostate mri contained in the pacs of the hospices civils de lyon * performed in 2016-2019 exclusion criteria: * mris from patients who already had treatment for prostate cancer

Keywords: prostate segmentation mr images
effectiveness of alzheimer's universe (www.alzu.org) on knowledge and behavior

Conditions: Alzheimer Disease; Alzheimer Disease, Late Onset; Memory Loss; Patient Education as Topic

Summary: to evaluate the effectiveness of an online educational course on alzheimer's disease (ad) prevention, treatment and caregiving.

alzheimer's universe (www.alzu.org) was created to provide online education about alzheimer's disease (ad), with a focus on family members of people with ad, people with mild cognitive impairment due to ad and mild ad, caregivers, healthcare providers, medical students, college students and high school students. the website provides evidence-based courses with interactive lessons and activities that have been shown to increase knowledge about ad, willingness to participate in an ad prevention clinical trial, and intent to make specific lifestyle changes in effort to reduce ad risk.

Eligibility criteria:
inclusion criteria: * greater than or equal to 14 years old with a friend, family member or acquaintance with alzheimer's disease or memory loss, or a person diagnosed with mild memory loss (including mild cognitive impairment due to alzheimer's disease or mild alzheimer's disease), or an ad caregiver, or healthcare providers, or a medical student, college student or high school student. exclusion criteria: * \< 14 years old, or diagnosis of moderate or severe alzheimer's disease
hypomethylating agents and venetoclax in newly diagnosed acute myeloid leukemia patients not eligible for intensive chemotherapy

Conditions: Acute Myeloid Leukemia, Adult; Hypomethylating Agents; Venetoclax

Summary: this is a retrospective, observational, monocentric study to evaluate the efficacy and safety of the combination of an hypomethylating agent with venetoclax newly diagnosed patients with acute myeloid leukemia ineligible for intensive chemotherapy

the prognosis of acute myeloid leukemia (aml) patients who are ineligible for intensive chemotherapy is poor (kantarjian et al). hypomethylating agents, azacitidine and decitabine, are effective and less toxic regimens, and treatment with these agents has improved the prognosis of these patients (fenaux et al). venetoclax, a bcl-2 inhibitor, in combination with azacitidine has shown efficacy in aml patients with complete remission rate of 73% and overall survival at 2 years of 40-50% (di nardo et al). on these grounds, the aim of this study is to collect the real-life experience with this combination in previously untreated aml patients.

Eligibility criteria:
inclusion criteria: * age ≥18 years * newly diagnosed acute myeloid leukemia not eligible for intensive chemotherapy exclusion criteria: * promyelocytic acute myeloid leukemia * patients who have already received one or more prior lines of therapy
effect of body mass on acyclovir pharmacokinetics

Conditions: Hematological Malignancy; Pharmacokinetics of Acyclovir

Summary: studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. this study will use blood samples taken at different time points for patients taking acyclovir to determine if higher body weights affect drug exposure. the information gathered from this study will help understand if patients with higher body weights need a different dosing plan. patients receiving acyclovir as standard of care will be enrolled into this study. they will have blood draws once before they take acyclovir and 10 times after they take the acyclovir (over a total of 12 hours). these patients will be in the hospital already and will not need to make additional trips back to have blood drawn. a total of about 4-5 tablespoons of blood will be drawn for this study. 7 obese patients and 7 matched, non-obese patients will be enrolled into this study.


Eligibility criteria:
inclusion criteria: * age ≥18 years of age * receiving intravenous acyclovir 5 mg/kg (total body weight \[tbw\] for normal weight patients and ideal body weight \[ibw\] for obese patients) as part of their routine care * admitted as an inpatient with an expected stay of at least 24 hours * weight \> 190% of ideal body weight (ibw) for "obese" patients or weight 80-120% of ibw for matched control patients. exclusion criteria: * receipt of acyclovir or similar agents (valacyclovir, ganciclovir, valganciclovir, famciclovir) in the prior 24 hours * serum creatinine \> 1.5 mg/dl at time of drug administration * hypersensitivity to acyclovir * patients requiring ventilator support or vasopressors in the prior 24 hours * receipt of probenecid, mycophenolate, tenofovir, or zidovudine in the prior 7 days * pregnant or breast-feeding * significant anatomical deformities that influence body habitus (i.e. amputation) * prior inclusion in this study

Keywords: acyclovir pharmacokinetics obese non-obese weight distribution clearance
summit study: a study of persistence to bonviva (ibandronate) once monthly in women with post-menopausal osteoporosis.

Conditions: Post Menopausal Osteoporosis

Summary: this 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly bonviva (150mg po) in women with post-menopausal osteoporosis. the study will also assess safety, quality of life and patient satisfaction. all patients will receive bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. the anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * ambulatory, post-menopausal women who would benefit from bisphosphonate treatment; * \>55 years of age; * naive to bisphosphonate therapy, or lapsed bisphosphonate users \>=6 months. exclusion criteria: * inability to stand or sit in an upright position for at least 60 minutes; * hypersensitivity to bisphosphonates; * treatment with other drugs affecting bone metabolism; * history of major upper gastrointestinal disease.
pain relief study of ultrasound guided transverse abdominis plane(tap)block

Conditions: Cesarean Section

Summary: the purpose of this study is to determine if injecting a local anesthetic, or numbing medication, above each hip will decrease the amount of narcotic pain medicine that is typically required by a patient after a cesarean delivery. ultrasound pictures will be used to guide placement of this injection. either ropivicaine (a type of numbing medication called a local anesthetic) or a placebo (saline) will be injected. for 24 hours, you will be given a button to press when you have pain. when the button is pressed, you will be given a small amount of pain medication called hydromorphone through your iv. you will also be given a pain medication called ketorolac through your iv every 8 hours for 24 hours after surgery.


Eligibility criteria:
inclusion criteria: * age 18 years or over * asa class 1 , 2 or 3 * bmi greater than 30 kg/m2 (as recorded at the patient's last clinic appointment or as measured on the day of delivery) * scheduled for cesarean section via pfannenstiel incision (with or without a tubal ligation) * 150 cm or taller * informed consent obtained exclusion criteria: * asa class 4 * age under 18 * relevant drug allergy * contraindication to spinal anesthesia * height \< 150 cm * patient receiving medical therapies considered to result in a tolerance to opioids * any other major surgical procedure performed other than cesarean delivery with or without tubal ligation * patient with relevant contraindications to ketorolac, such as history of gastrointestinal bleeding or impaired renal function * patient refusal

Keywords: c-section cesarean section tap block pain pain after delivery pain after c-section pain after c-section delivery pain after cesarean delivery pain after cesarean
use of trastuzumab to induce increased er expression in er-negative/low, her-2/neu positive breast cancer

Conditions: Breast Cancer

Summary: the majority pf breast cancers present as er-positive, many of which are able to be targeted with multiple hormonal therapies. altering er-negative tumors to increase er expression has the potential to benefit patients by making hormonal therapies a therapeutic option and possibly improving their overall prognosis.


Eligibility criteria:
inclusion criteria: * women who have her-2 positive and er- negative or er-low breast cancer that has not metastasized, or spread to other parts of the body, are eligible for the study. * participants must have had either a core biopsy or incisional biopsy of their breast cancer, but not yet had definitive breast surgery, including lumpectomy or mastectomy. * participants may not have had a brca mutation found on genetic testing. * participants should have not yet received treatment for their breast cancer, including: * chemotherapy, * hormonal therapy, * trastuzumab.

Keywords: breast cancer women w/her2 positive ernegative not metastasized
development of a risk prediction algorithm through the investigation of genetic risk factors and the complexity of coronary artery disease to estimate future risk of cardiovascular events: angiographic (syntax score), clinical and pharmacogenetic analysis.

Conditions: Coronary Artery Disease

Summary: the purpose of the research project is to investigate the potential association of 207 genetic polymorphisms with the complexity and the severity of coronary artery disease (syntax score), along with the patients' response to clopidogrel and statin therapy. the aim of the study is to combine genetic, pharmacogenetic, clinical and laboratory data in order to create an algorithm (genetic syntax score-gess) that will enable an individualized therapeutic patient approach.

regarding greece, this is the first prospectively enrolling medical database of this magnitude. clinical and genetic patient information are systematically collected in a fashion that will enable also future retrospective evaluation of clinical and genetic details from each patient. this study is a discrete arm of a series of research projects that focus on the development of personalized medical therapy and share a common purpose: predicting future risk of cardiovascular events, assessing the severity and complexity of coronary artery disease by incorporating genetic information into the syntax score and providing personalized therapeutic guidance to patients. the ultimate goal of the study would be to identify, design and develop a panel of genetic markers that in combination with clinical and angiographic information will be a reliable tool for predicting cardiovascular risk for future adverse events.

Eligibility criteria:
inclusion criteria: 1. patients giving voluntary written consent to participate in the study 2. male or female patients between 18 years to 90 years at entry 3. patients without previous history of cad 4. patients who are admitted in the department of cardiology in the ahepa university general hospital of thessaloniki and undergo coronary angiography for clinical purposes exclusion criteria: 1. patients \ 90 years old at time of coronary angiography 2. patients with a previous history of cad 3. cardiac arrest at admission 4. patients with serious concurrent disease and life expectancy of \< 1 year 5. patients who refuse to give written consent for participation in the study

Keywords: syntax score snps genetics pharmacogenetics genetic risk score precision medicine
early versus delayed bcg vaccination of hiv-exposed infants

Conditions: HIV Exposure; HIV Infection

Summary: in sub-saharan africa (ssa), more than 300,000 babies with hiv die each year. hiv-infected children develop aids and die faster in ssa than those in developed countries. bacille calmette-guerin (bcg) vaccine is given to infants at birth in ssa to protect them from severe forms of tb. bcg is known to cause immune cells to be active and replicate faster. the immune system of neonates also responds differently to bcg that to other vaccines and infections. we hypothesize that the routine immunization of neonates with bcg contributes to generalized immune activation in hiv-exposed infants resulting in skewed immune responses to vaccines and infections and increased rates of disease progression in those infants that become hiv-infected. however, delaying bcg until hiv testing is completed would result in operational difficulties, and may not induce the appropriate immune response. delayed bcg would also render many hiv-exposed uninfected infants at high risk for disseminated tb. we plan to assess immune cells in infants to determine the impact of the timing of bcg vaccination on immune responses to tuberculosis (tb) and other vaccines. we will also compare the immune activation and disease progression of those infants that become hiv-infected in the bcg or control arms. our results will provide key insights into the effect of bcg vaccination on immune responses to hiv as well as inform the optimal timing of bcg vaccination for hiv-exposed infants.


Eligibility criteria:
inclusion criteria: * healthy neonate * maternal hiv * \> 36 weeks gestation * birth weight \> 2.4kg * remaining in area 4 months exclusion criteria: * complications during pregnancy and delivery * household tb contacts

Keywords: vaccine immunogenicity immune activation
indwelling stent discoloration project

Conditions: Urologic Injuries; Disorder of Urinary Stent; Kidney Calculi; Urinary Tract Obstruction Due to Specified Cause; Hydronephrosis

Summary: the aim of this study is to identify the root cause for the significant discolouration of boston scientific percuflex based stents.

the aim of this study is to identify the root cause for the significant discolouration of boston scientific percuflex based stents observed in some patients, particularly those from japan. we will also test and compare them to stents from canadian patients. furthermore, we will determine whether the discolouration promotes bacterial adhesion and/or encrustation of the stent.

Eligibility criteria:
inclusion criteria: * patient is at least 19 years of age (vancouver, british columbia, canada - for japan different age limit as applicable) * patient has indwelling ureteral stent exclusion criteria: * pregnancy * positive urine culture * active cancer * recurrent urinary infections * gross hematuria * inability to provide informed consent * physician/surgeon refuses to enter patient into study

Keywords: urological problems indwelling urologic stent kidney stone disease urinary system obstruction hydronephrosis ureteral damage
hand rehab using amadeo in pd patients

Conditions: Parkinson Disease

Summary: hand movements are particularly impaired in parkinson's disease (pd) patients contributing to functional disability and difficulties in activities of daily living. amadeo®. is an end-effector system enables intensive training with frequently repeated gripping movements. it offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers.aim of this study is to evaluate the efficacy of the end-effector finger system, amadeo®, on hand-finger movements in pd patients evaluating the improvement on finger tapping and agility of hand movement item scores on the mds-updrs, variation on the active finger strengths and the active and passive range of motion (rom); variation on electromyographic (emg)-parameters.


Eligibility criteria:
inclusion criteria * idiopathic pd diagnosed according to the gelb's criteria; * hoehn-yahr stage 1- 3 * "on" state * mmse score ≥ 24 * willing and able to give written informed consent; * willing and able to comply with the study procedures. exclusion criteria * a specific kind of fluctuation: sudden on-off fluctuations * history sign or symptoms suggesting the diagnosis of atypical or secondary parkinsonisms; * history of stereotaxic brain surgery for pd; * mini-mental examination (mmse) score less than 24 at screening; * changes in levodopa (da) dose in any time within 4 week prior to baseline; * changes in dopamine agonists (da) in any formulation in any time within 4 week prior to baseline; * presence of severe dyskinesia prior to baseline; * any other medical or psychiatric condition that may compromise the patient's participation in this study;
a single center, randomized, double-blind, crossover pilot trial comparing the onset of action of parcopa™ with sinemet® in subjects with stable parkinson's disease

Conditions: Parkinson's Disease

Summary: to test whether parcopa, a new orally disintegrating tablet of carbidopa-levodopa, has a faster onset of action, changes in the updrs motor exam score at intervals after a single dose of parcopa or sinemet are being compared in 10 subjects with parkinson's disease. subjects 40 years or older having idiopathic pd with hoehn and yahr state ii or iii are eligible if taking a stable dose of \< 200 mg carbidopa and \< 2000 mg levodopa daily. at both treatment visits, either parcopa or sinemet, plus a placebo of the opposite tablet (odt or conventional) are administered. the dose is the same as the subject's prestudy regimen. the primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. all updrs evaluations are done by a rater blinded to the active treatment received by the subject.

see approved package insert for adverse event information.

Eligibility criteria:
inclusion criteria: * stable parkinson's disease exclusion criteria: * idiopathic pd with hoehn and yahr state ii or iii