Kornimate/medical-research-clean huggingface dataset:
contrast enhanced ultrasound for evaluation of reflux nephropathy

Conditions: Urinary Tract Infection; Vesicoureteral Reflux

Summary: the study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.


Eligibility criteria:
inclusion criteria: * informed consent * age more than or equal to 8 years * patient with history of urinary tract infection (uti) and history of voiding cystourethrogram (vcug) for vesicoureteral reflux * candidate for dimercaptosuccinic acid (dmsa) scan or scan for renal scar * demonstration of renal scarring by dmsa scan or renal ultrasound without contrast includes healthy volunteers exclusion criteria: * age less than 8years * allergy to contrast or related products * cardiac shunt/ congenital heart anomalies * abnormal baseline ecg * open heart surgery * evidence of retinopathy * patient in intensive care * unable to comply with study requirement * history of emphysema * unable to maintain oxygen saturation of 92% on at room air * pregnancy and lactation
osa in pregnant women with chronic htn

Conditions: Sleep Apnea, Obstructive; Pregnancy; Hypertension

Summary: the purpose of this study is to identify whether pregnant women with chronic hypertension are at significantly higher risk of having undiagnosed osa and should be routinely screened with home sleep tests. the investigators will recruit 120 pregnant subjects between 10-20 weeks gestation from the duke high risk obstetrics clinic over a 20-month period. they will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented at 3 clinic visits); 2) normal blood pressure, and not on any treatment for chronic htn and no history of chronic htn, and matched for bmi (+/- 3 kg/m2) with the chronic htn group. the two groups will be matched for bmi to control for the effect of obesity on osa diagnosis and chtn. the primary hypothesis, that osa prevalence differs between patients with chronic htn and normotensive controls, will be assessed with a two-group two-sided fisher's exact test. a fisher's exact test with a 0.05 two-sided significance level will have 92% power to detect the difference between a normotensive osa rate of 0.10 and a chronic hypertensive osa rate of 0.40 when the sample size in each group is 50. there are no risks associated with the use of the home sleep test device, but subjects that have a severe latex allergy should not participate, as the device


Eligibility criteria:
inclusion criteria: * pregnant woman who are patients of:duke hospital, duke birthing center (dbc), duke perinatal durham clinic, inpatients will be recruited from the obstetric antepartum service. * gestational age 10 weeks, 0 days to 20 weeks, 6 days * 18 years or older * english speaking * they will be enrolled into one of two groups:-chronic hypertension (on medication or hypertensive blood pressures documented on two clinic visits (including prior to pregnancy), -normal blood pressure, and not on any treatment for chronic htn and no history of chronic htn, and matched for bmi (+/- 3 kg/m2) with the chronic htn group * the two groups will be matched for body mass index to control for the effect of obesity on osa diagnosis and htn. * subjects will be not be excluded if they have an established diagnosis of osa that is not currently being treated. exclusion criteria: * being treated for osa * on chronic opioids * on alpha-blockers (which can interfere with the pat signal) * have secondary htn * unwilling to remove nail polish and/or shorten one nail (which can also interfere with the pat signal) * have a severe allergy to latex * do not speak english.

Keywords: sleep disordered breathing obstructive sleep apnea hypertension pregnancy
follow-up in rivaroxaban patients in setting of thromboembolism

Conditions: Venous Thromboembolism

Summary: in patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators will collect real world data on their short and long term outcomes. the investigators hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment will be non-inferior to treatment with conventional anticoagulants (heparins and warfarin); 2. there will be less bleeding than when patients are on conventional anticoagulants; 3. there will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary hypertension and post-thrombotic limb syndrome.

united kingdom-only prospective, non-interventional, investigator-led, multi-centre, single cohort, registry. the observation period for each patient covers the treatment period with rivaroxaban and follow up until study end. for each patient, the treating health care professional records patient demographics, medical history, signs and symptoms, diagnosis, treatment and safety parameters at an initial visit and subsequent follow-up visit(s). data monitoring will be undertaken by the sponsor.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older with an objectively verified diagnosis of dvt and/or pe and treated according to routine clinical practice with rivaroxaban exclusion criteria: * patients in whom follow-up is unlikely or impossible * patients unable to give consent * patients who receive heparin therapy for more than 48 hours * patients who receive more than one dose of warfarin * patients with an indication for anticoagulation other than dvt and/or pe * all contraindications listed in the local product information (smpc) will form part of the exclusion criteria

Keywords: pulmonary embolism pe deep vein thrombosis dvt rivaroxaban venous thromboembolism chronic thromboembolic pulmonary hypertension post thrombotic limb syndrome root cause analysis
explore the relationship between heart rate variability, body mass index, inflammation, and insulin resistance.

Conditions: Obesity; Insulin Resistance; Overweight

Summary: the findings will serve as a reference for clinical professionals to promote exercise among the general population for improving hrv.

background: heart rate variability (hrv) measurement is widely used to assess the function of cardiac autonomic modulation. aerobic exercise (ae) has been proven to improve hrv. however, because hrv is highly associated with visceral fat, inflammatory status, and insulin resistance, whether baseline body inflammation status can explain the heterogeneous response to ae remains unknown. purposes: we will compare the effects of ae training in improving hrv, inflammatory markers, and insulin resistance between community residents with normal weight and overweight/obesity. methods: a quasi-experimental study with purposive sampling will be used to recruit community residents aged 40-64 years with inactive habits in southern taiwan. the minimum targeted sample size is 43 participants. the participants will be grouped into normal weight and overweight/obese groups. all participants will receive ae training with at least moderate intensity three times per week. hrv parameters, blood samples, and visceral fat will be evaluated. the blood samples will be evaluated for c-reactive protein and markers of insulin resistance (fasting glucose, insulin). all participants will be evaluated at baseline (t0) and after a 16-week intervention (t1). in addition to these time points, hrv will be measured during every exercise session for participants in exercise groups. generalized estimating equations will be used to determine whether baseline bmi is the key factor influencing the effects of ae. relevance to clinical practice: the findings will serve as a reference for clinical professionals to promote exercise among the general population for improving hrv.

Eligibility criteria:
inclusion criteria: * are aged between 40 and 64 years. * had inactive habit (\<3 days of physical activity per week and \<30 minutes per session). * can communicate in mandarin or taiwanese. exclusion criteria: * underlying conditions, such as stroke, acute coronary artery diseases, handicap, pregnancy, and unstable hypertension, that may present risks for exercise training. * smoking or alcohol abuse. * currently being on a diet, and (d) lifestyles that may affect hrv and inflammatory biomarkers (e.g., shift work or habit of staying up late).

Keywords: heart rate variability exercise inflammation insulin resistance
exercise training in adults with corrected tetralogy of fallot

Conditions: Tetralogy of Fallot

Summary: in this controlled trial, patients with tetralogy of fallot will be randomized to either interval training, continuous training, or usual care groups.

patients after surgical correction of tetralogy of fallot (ctf) have impaired exercise tolerance as compared to healthy age-matched individuals. in this controlled trial, patients with ctf will be randomized to either interval training, continuous training, or usual care. the aim of the study is to compare the effect of interval vs. continuous exercise training on: i) exercise capacity ii) vascular function iii) arrhythmogenic potential iv) parameters of inflammation, hemostasis and heart failure severity v) health-related quality of life adults with ctf

Eligibility criteria:
inclusion criteria: * congenital tetralogy of fallot surgically corrected in childhood exclusion criteria: * contraindications for exercise training, * uncontrolled dysrhythmias, * uncontrolled heart failure (new york heart association (nyha) stage iv), * unstable coronary or other arterial disease, * intellectual development disorder, * pregnancy.

Keywords: exercise training
prediction of preeclampsia & other obstetric complications by serum homocysteine & doppler

Conditions: Preeclampsia; IUGR

Summary: second trimester homocysteine \& uterine artery doppler will be assessed\& the cases will be followed up till delivery for development of preeclampsia, iugr(intra-uterine growth retardation) \& other obstetric complications.

spontaneous pregnancies with no risk factors will be included. fasting plasma total homocysteine level samples will be collected between 15th \& 19th weeks. uterine artery doppler between 18th \& 22nd weeks. method 1: screen positive cases will be considered if homocysteine level above 6.3umol/l method 2: screen positive cases will be considered if they had bilateral notches and a mean resistivity index (ri) above 0.55, or unilateral notches and a mean ri above 0.65, or absence of notches and a mean ri above 0.7. method 3: screen positive cases will be considered if they had bilateral notches and a mean ri above 0.55, or unilateral notches and a mean ri above 0.65, or absence of notches and a mean ri above 0.7 combined with homocysteine cut off value of 6.3umol / l.

Eligibility criteria:
inclusion criteria: * spontaneous pregnancies with no risk factors exclusion criteria: * multiple pregnancies * non intact renal function * hypertension * diabetes * folic acid supplements * antifolate drugs
observational study in adults with imatinib-resistant/intolerant chronic myeloid leukemia treated with nilotinib

Conditions: Chronic Myeloid Leukaemia

Summary: the gimema cml working party promotes an observational (retrospective and perspective) study of imatinib-resistant or intolerant cml patients treated with nilotinib in italy. enrollment will include all patients who started nilotinib between january 2005 and december 2012. patients will be followed for 4 years since treatment start. after this time, survival data, disease status and treatment will be recorded at 6-months-interval. this study will help the definition of guidelines for a proper management of nilotinib in any-phase cml patients.

follow-up is required until the end of treatment for the purposes of the study for all patients by standard hematologic, cytogenetic and molecular criteria. this study will not contemplate any additional expense beyond what is expected for a regular follow-up, according to the international guidelines for cml. sample size: target accrual was not defined, all eligible patients observed between january 2005 and december 2012 will be included.

Eligibility criteria:
inclusion criteria: * adult patients with imatinib resistant (failure + suboptimal) or intolerant chronic myeloid leukaemia in all phases, who started treatment with nilotinib between january 2005 and december 2012 in italy. * adult pts treated with nilotinib as second line therapy after dasatinib. exclusion criteria: * patients less than 18 year old. * use of nilotinib as first line treatment. * patients treated with nilotinib before 2005.

Keywords: imatinib chronic myeloid leukaemia nilotinib adult patients imatinib resistant
impact of 18f-fdg pet-ct versus conventional staging in the management of patients presenting with clinical stage iii breast cancer

Conditions: Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4); Stage IIb Breast Cancer (T3N0)

Summary: this trial is being conducted to determine the impact of whole body fdg pet-ct vs. conventional staging in the management of patients presenting with clinical stage iii breast cancer. eligible consenting patients with ductal or mixed histology breast cancer will be randomized 1:1 to whole body fdg pet-ct or conventional staging. eligible consenting patients with lobular only histology will be entered into a separate single arm prospective study and will undergo whole body fdg pet-ct, ct with contrast of the chest/abdomen \& pelvis and a bone scan.


Eligibility criteria:
inclusion criteria: * women (or men) with histological evidence of breast cancer for whom potentially curative treatment is planned. * based on clinical information (physical exam, imaging): 1. stage iii breast cancer (t0n2, t1n2, t2n2, t3n1, 2 or t4), or 2. stage iib breast cancer (t3n0), note: t2n1 is not eligible * considered for combined modality therapy (surgical resection, chemotherapy, radiotherapy) of curative intent. exclusion criteria: * age \< 18 years, * ecog performance status \> and = 3, * prior systemic therapy (e.g. neo-adjuvant chemotherapy or hormonal therapy) for current breast cancer, * previous staging investigations for current breast cancer, * breast cancer with primary histological subtypes other than ductal or lobular (note: patients with mixed disease will be eligible for randomization), * clinical suspicion of metastatic disease, * relative contraindications to pet (e.g. uncontrolled diabetes (i.e. inability to decrease serum glucose below 10.2 mmol/l), claustrophobia, inability to be still for 30 minutes), * inability to lie supine for imaging with pet-ct, * inability to undergo ct because of known allergy to contrast, * history of another invasive malignancy within the previous two years (exception of non melanoma skin cancer) or a synchronous primary cancer, including a synchronous contralateral breast cancer (note: patients found to have a contralateral breast cancer on study imaging following randomization will remain in the study), * known pregnancy or lactating female, * inability to complete the study or required follow-up.
maastricht neck study: cervical range of motion in whiplash patients

Conditions: Whiplash Injuries

Summary: rationale: neck complaints are often caused by motor vehicle accidents and particular after rear-end collision. patients complain about neck pain after a whiplash trauma, which lead to mobility restrictions of the cervical spine. it is estimated that 20% develop a chronic pain disorder after 1 year, called a chronic whiplash syndrome. objective: the primary objective is to investigate the natural course of active-and passive range of motion and principally the difference score between active-and passive cervical range of motion after a whiplash trauma. the secondary objectives are: investigate the predictive value of active-and passive range of motion and chronicity. further, the correlation between the degree of restriction of the active and passive backward flexion and chronicity will be investigated. finally, the correlation between the possible predictive factors such as pain, ideas and feeling about pain, memory and attention, events of the last year and complaints after the motor vehicle accident and chronicity are examined. study design and study population: a prospective cohort of 100 whiplash patients which underwent a measurement of the cervical movements and gave permission to recontact them for further research.


Eligibility criteria:
inclusion criteria: * patients have had a measurement of the cervical range of motion. exclusion criteria: * none.

Keywords: range of motion, articular cervical spine
severe impairment of solute-free water clearance in patients with hiv infection

Conditions: HIV Infection

Summary: the objective of the present study is to analyze the overall tubular function, and in particular that from the proximal tubule and the thick ascending loop of henle (talh) in patients with hiv infection receiving or not tenofovir-containing antiretroviral treatment in comparison with seronegative controls, by applying a validated tubular physiological test known as "low sodium infusion test". hypothesis is that patients with hiv infection and normal renal function will show subclinical tubular abnormalities compared with seronegative controls

renal disease is a well recognized complication among patients with hiv infection. either viral infection itself and the use of some antiretroviral drugs contribute to this serious non aids-defining condition that may affect both the glomeruli and the renal tubules. the thick ascending loop of henle constitutes the main location for free-water clearance determining kidney´s ability to concentrate and dilute urine in a direct and indirect fashion, respectively.

Eligibility criteria:
inclusion criteria: * inclusion criteria are as follows: adult patients (≥18 years old) with confirmed chronic hiv-1 infection who agreed to provide written informed consent. patients under antiretroviral treatment must had a stable regimen for over six months and undetectable (\<50 copies/ml) viral load for at least three months. at study entry all selected patients were confirmed as having normal physical examination, routine clinical laboratory including urinalysis, as well as renal and cardiac ultrasound. exclusion criteria: * exclusion criteria include patients with acute hiv infection (\< 6 months of disease), personal history of nephropathy, plasma creatinine ≥1.3 mg/dl, glomerular filtration rate ≤60ml/min/1.73 m² (as determined by modification of diet in renal disease formula), presence of glucosuria/proteinuria (measured in spot urine sample), prior heart failure, concurrent opportunistic infection, chronic active hepatitis b or c, and use of potentially nephrotoxic agents in the prior week before the test (e.g diuretics, angiotensin converting enzyme antagonists, angiotensin ii receptor antagonists or non-steroidal anti-inflammatory agents).

Keywords: hiv infection antiretroviral treatment renal disease renal tubular damage free-water clearance
antiplatelet effects of ticagrelor versus clopidogrel in american indian patients

Conditions: Coronary Artery Disease

Summary: assess the pharmacodynamic effect of ticagrelor vs. clopidogrel in american indian patients with stable coronary artery disease.

a single center, randomized, open label, multiple dose, crossover study of the antiplatelet effects of ticagrelor versus clopidogrel in american indian patients with stable coronary artery disease

Eligibility criteria:
inclusion criteria: * documented stable cad fulfilling any of the following, and taking 81mg asa daily treatment: * females must be post menopausal for at least one year or surgically sterile for at least 6 months and negative urine pregnancy test * self-identified as american indian * genetic inclusion criteria: must sign the informed consent for genetic and biological sample banking. exclusion criteria: * any indication for oral anticoagulant or dual antiplatelet treatment * concomitant therapy with strong cyp3a inhibitors, cyp3a substrates with narrow therapeutic index, or strong cyp3a inducers within 14 days and during study treatment and during: * increased bleeding risk including: * diabetic patients with hbalc \> 10% at screening * contraindication to clopidogrel, asa, or ticagrelor - a history of alcohol and/or substance abuse that could interfere with conduct of the trial * patients requiring dialysis * patients scheduled for revascularization (e.g., pci, cabg) during the study period * any acute or chronic unstable condition in the past 30 days * known active or recurrent hepatic disorder * patients who had acs or stent placed within 12 months of screening * history of uric acid nephropathy

Keywords: clopidogrel ticagrelor coronary artery disease myocardial ischemia coronary disease heart diseases cardiovascular diseases arteriosclerosis arterial occlusive diseases vascular diseases platelet aggregation inhibitors hematologic agents therapeutic uses pharmacologic actions purinergic p2y receptor antagonists purinergic p2 receptor antagonists purinergic antagonists purinergic agents physiological effects of drugs
indocyanine green fluorescence during fundus first laparoscopic cholecystectomy

Conditions: Gallstone; Gallstone; Cholecystitis, Acute

Summary: laparoscopic cholecystectomy is the routine method for managing gallstone disease. this is considered a safe procedure with low risk of severe complications. lesions to the deep bile ducts is, however, a rare complication from laparoscopic cholecystectomy that may have devastating consequences. the risk of bile duct injuries may be reduced by adapting the surgical approach. in general, the operation is started from the lower part of the gallbladder and continued upwards. it may, however, also be initiated from the top of the gallbladder and extended downwards. this approach, also termed fundus first, is routine at a few units. by injecting indocyanin green (icg) that is excreted into the bile, the bile ducts may be visualized using near infrared light. this is a technique for mapping the anatomical structures adjacent to the gallbladder that has been used in previous studies for preventing bile duct injuries. this method has, however, not been tested at units where fundus first is the routine surgical technique. in the present randomized controlled trial, the investigators intend to evaluate the safety of icg as a means for reducing the risk of bile duct lesions and to see if it works as intended. altogether 294 operations for gallstones will be included in the study. the patients will be randomized to surgery with or without icg. regardless of the randomization, all operations will be undertaken with the fundus first technique. thirty days after the operation, all data related to the operation are retrieved from the patient records by an assessor that does not know what group the patient was randomized to. the primary endpoint of the study is the time required from the start of the operation until intraoperative cholangiography is done. in addition, total operative time, all surgical complications and need for converting the operation to an open procedure will be recorded.


Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic cholecystectomy * verbal and written consent provided * age ≥ 18 years exclusion criteria: * thyroid disease * allergy against icg or iodine

Keywords: cholecystectomy indocyanine green bile duct injury intraoperative cholangiography fundus first