Kornimate/medical-research-clean huggingface dataset:
outcome after tips

Conditions: Hypertension, Portal; Liver Cirrhosis; Variceal Hemorrhage; Ascites Hepatic

Summary: this clinical trial is a retrospective single-centre study. research data will be acquired via patient histories stored in the hospital data system. data of patients who received a transjugular intrahepatic portosystemic shunt (tips) at the university hospital graz between 1.1.2004 and 31.12.2017 will be included into the study. the aim is to investigate the outcome (transplantation free survival, time to (re)occurrence of ascites, occurrence of hepatic encephalopathy) of patients with portal hypertension after tips.

the implantation of a transjugular intrahepatic portosystemic shunt (tips) is a valuable measure to reduce portal hypertension and prevent portal hypertension-related complications. it can be used as a symptomatic treatment in patients with chronic portal hypertension as well as for the treatment of active variceal bleedings or large gastrointestinal varices that go along with threatening bleeding danger. however, this invasive procedure carries a high risk for complications. 30-days mortality after tips implantation amounts between 4% and 45%. a common complication is the (initial) manifestation or deterioration of hepatic encephalopathy, which occurs in 33-46 % after tips implantation. other complications that are directly related to the intervention are bleeding, infections and stent migration. aim of this retrospective single centre study is to investigate the long-term outcome after tips implantation with regard to transplantation free survival and time to (re-) occurrence of portal hypertension-related complications, especially ascites and hepatic encephalopathy. intervention-related complications as well as long-term effects should be evaluated to facilitate the decision for or against tips.

Eligibility criteria:
inclusion criteria: * every person at the age of 18-90 years who received a transjugular intrahepatic portosystemic shunt at the university hospital of graz/austria between 1.1.2004 and 31.12.2017 exclusion criteria: * age under 18
effects of auricular acupressure versus intermittent dietary restriction in children with gastric heat and dampness obstruction

Conditions: Obesity, Childhood

Summary: this is a three-month randomized controlled trial to investigate the effects of auricular acupressure versus intermittent carbohydrate restriction on cardiometabolic risk in obese children with gastric heat and dampness obstruction.

obesity in childhood is associated with multiple cardiometabolic risk factors including hyperglycemia, dyslipidemia and hypertension, which predicts increased risk for developing obesity-driven complications in adulthood. auricular acupuncture therapy is an intervention with purported success for the treatment of obesity. however, traditional intervention rarely has long-term success in children and adolescents. low-carbohydrate diets have also been shown to reduce body weight and improve insulin sensitivity in children. this is a three-month randomized controlled trial in children with gastric damp-heat obstruction, in order to explore the effects of traditional chinese medicine auricular acupressure and intermittent carbohydrate restriction on cardiovascular metabolic health.

Eligibility criteria:
inclusion criteria: * have at least one of the following cardiometabolic risk factors: overweight or obesity, prediabetes, dyslipidemia or elevated blood pressure. * traditional chinese medical syndrome type is gastric heat and dampness obstruction syndrome. exclusion criteria: * diagnosis of obesity associated with genetic or endocrine diseases, including hypercortisolism, polycystic ovary syndrome, primary hypothyroidism and hypothalamic obesity. * participating in other clinical trials or have participated in other clinical trials in recent 3 months. * diagnosis of organic diseases, including heart, liver, kidney and brain or infectious diseases and mental diseases.

Keywords: auricular acupressure intermittent dietary restriction gastric heat and dampness obstruction
prognostic significance of lymph node yield and lymph node ratio prospective observational study

Conditions: Head and Neck Cancer

Summary: it is still unclear if lymph node yield (lny) and lymph node ratio (lnr) may have a prognostic role in patients affected by carcinoma of the oral cavity and the oropharynx. only retrospective studies are available. for this reason, this prospective, multi center, observational study should provide indications in this regard. proper stratification by patients characteristics will allow to understand if lny and lnr may enter in the future tnm staging system

lymph node involvement is a fundamental prognostic factor in head and neck squamous cell carcinoma (scc). lymph node yield (lny), which is the number of lymph nodes retrieved after neck dissection, and lymph node ratio (lnr), which is the ratio of positive lymph nodes out of the total removed, are measurable indicators that may have the potential to be used as prognostic factors. the present study is designed to define the exact role of lny and lnr regarding the overall and specific survival of patients affected by oral cavity and oropharyngeal scc. this is a multicenter study involving tertiary care referral centers in europe and north america. patients affected by oral cavity, hpv+ and hpv- oropharyngeal scc undergoing neck dissection will be consecutively enrolled and followed-up for up to 5 years. patients and disease characteristic will be properly recorded and centrally analyzed. the primary end-point is to define reliable cut off- values for lny and lnr which may serve as prognosticators of survival. this will be achieved through the use of roc curves. secondary outcomes will be the overall survival (os), disease specific survival (dss), and progression free survival hazard ratios (hr) at 2-, 3- and 5 years, which will be evaluated through the kaplan-meier method and the difference in survival attested by the log-rank test. univariate and multivariate analysis will be performed to understand the association of various outcomes with lny and lnr.

Eligibility criteria:
inclusion criteria: * patients affected by oral cavity, oropharynx, larynx squamous cell carcinoma exclusion criteria: * patients affected by other cancers
evaluation of the periodontal status after the treatment of palatally impacted canines using acceleration procedures

Conditions: Impacted Canine

Summary: impacted canine causes many problems for patients, such as damage to the adjacent teeth roots, effects on gingival tissues, aesthetic problems, difficulty, and prolonged orthodontic treatment duration. therefore, solutions to accelerate the movement of impacted canines with the help of surgical procedures to reduce treatment time will be investigated, such as intra-operative alveolar perforations and piezocision. we also aimed to evaluate periodontal changes associated with such accelerating procedures compared with the conventional traction method.

patients with palatally impacted maxillary canines will be treated using fixed appliances assisted by some surgical procedures. the effects of this treatment approach on the periodontal status will be assessed using periodontal measurements. there are two groups : 1. conventional treatment group 2. minimally-invasive corticotomy-assisted treatment group patients will be allocated to the two groups randomly. data will be collected using periodontal variables.

Eligibility criteria:
inclusion criteria: 1. age of patients: 18-28 years. 2. palatal or mid-alveolar impacted canine. 3. there is no previous orthodontic treatment. 4. healthy periodontal tissues and good oral health (i.e., the plaque index is less or equal to 1 according to loe and silness(1963). 5. the patient does not take any drug that may interfere with the tooth movement (cortisone, nsaids ...). 6. mild or no crowding on the upper jaw. 7. no history of previous trauma to the maxillofacial region or surgical interventions. exclusion criteria: 1. any systemic diseases that would affect tooth movement 2. antidepressant prevents oral surgery 3. any congenital syndromes or cleft lip and palate cases 4. bad oral health 5. previous orthodontic treatment

Keywords: impacted canine accelerate canine traction periodontal index periodontal status
imaging markers of subclinical cardiotoxicity in breast cancer

Conditions: Breast Cancer

Summary: this research study is evaluating the use of cardiac magnetic resonance imaging (cmr) as a method of detecting early signs of damage to the heart that can be associated with anthracycline-based chemotherapy for the treatment of breast cancer.

one of the side effects observed in breast cancer patients receiving anthracycline-based treatment is heart complications in which the heart muscle is weakened and no longer able to pump sufficient amounts of blood throughout the body. this complication can lead to the following symptoms: shortness of breath on exertion, swollen ankles and feet, lack of energy and a reduced capacity to carry out day-to-day activities. this research study is focused on identifying the early signs of such heart complications using cmr, which may allow preventative treatment options to be made available in future.

Eligibility criteria:
inclusion criteria: * age \> 18 years * have histologic diagnosis of breast carcinoma * scheduled to receive standard clinical therapy designed by their treating oncologist * patients should receive anthracycline as part of the recommended treatment * able to give informed consent. exclusion criteria: * contraindication to contrast cmr including egfr \<30 mls/min/1.73m2 * uncontrolled serious concurrent illness * pregnancy or breast feeding
atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events (active w)

Conditions: Atrial Fibrillation; Vascular Risk

Summary: the purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.primary objectives :the combination of clopidogrel plus aspirin compared to adjusted dose (inr between 2.0 and 3.3) oral anticoagulation (a vitamin k antagonist) will result in the same risk of the composite outcome of stroke, non-cns systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.the secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.


Eligibility criteria:
inclusion criteria: * evidence of atrial fibrillation either on one current electrocardiogram (ecg) or on two ecg recorded at two weeks a part during 6 months prior to study enrollment. * evidence of high risk of vascular events: at least one of the following risk criteria must be present: * are 75 years or greater; * on treatment for systemic hypertension; * prior stroke, tia, or non-cns systemic embolus; * left ventricular dysfunction with left ventricular ejection fraction (ef) estimated by echocardiogram or angiogram (radionuclide or contrast) to be \< 45%; * peripheral vascular disease (previous peripheral artery revascularization, limb and foot amputation, or the combination of current intermittent claudication and ankle arm systolic blood pressure ratio \< 0.9); * age 55 to 74 years; and * either diabetes mellitus requiring drug therapy, or documented previous myocardial infarction, or documented coronary artery disease. exclusion criteria: * patients will be excluded from active if any of the following are present : * requirement for clopidogrel (such as recent coronary stent procedure); * requirement for oral anticoagulant (such as prosthetic mechanical heart valve); * prior intolerance to asa or clopidogrel; * documented peptic ulcer disease within the previous 6 months; * prior intracerebral hemorrhage; * significant thrombocytopenia; (platelet count \< 50 x 10(9)/l); * psychosocial reason making study participation impractical; * geographic reason making study participation impractical; * ongoing alcohol abuse; * mitral stenosis; * pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study; * severe comorbid condition such that the patient is not expected to survive 6 months; * patient currently receiving an investigational pharmacologic agent; or * requirement for chronic (\> 3 months) non-cox-2 inhibitor nsaid therapy.

Keywords: atrial fibrillation anticoagulant therapy thromboembolic prevention
effects of dual-site anodal transcranial direct current stimulation on attention, decision-making and working memory during sports fatigue in elite soccer athletes

Conditions: Sports Fatigue

Summary: investigation of the effects of dual-site anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex or primary motor cortex on attention, decision-making and working memory during sports fatigue in elite soccer athletes


Eligibility criteria:
inclusion criteria: * elite soccer athletes exclusion criteria: * goalkeepers * pregnancies * family history of epilepsy * metallic head implants * neurological, psychiatric, or musculoskeletal disorders * severe sports injuries

Keywords: transcranial direct current stimulation primary motor cortex prefrontal cortex cognitive function sports fatigue
hiv/aids orphaned and vulnerable children public health evaluation

Conditions: Adolescent Behavior; Risk Reduction Behavior; Stress, Psychological

Summary: the phe study is a two-year longitudinal study evaluating two interventions for reducing depression and hiv risk behaviors among highly vulnerable adolescents in the eastern cape of south africa. research suggests that children affected by aids are at heightened risk of hiv infection relative to their peers; however, evidence on how best to address hiv prevention and psychological health among this population is lacking. this study examines the efficacy of both a psychological and behavioral intervention, alone and in combination, on related outcomes among vulnerable youth age 14-17. a mixed methods approach is applied, including a community-randomized controlled trial with a factorial design, a cost-effectiveness analysis, and a qualitative component. at baseline data collection in january 2012, more than 1000 adolescents and their caregivers were interviewed; these participants were invited to take part in two more survey rounds designed to examine both the immediate and long term effects of the interventions. support for this research was provided by usaid under grant no. ghh-i-00-007-00069-00.

the study will apply a mixed-methods approach involving two primary components: 1) an impact evaluation using a community-randomized controlled trial (crct); and 2) a detailed analysis of intervention costs, linked to the impact evaluation to determine the cost-effectiveness of these interventions. for the crct, sixty world vision drop-in centers which deliver standard care were randomly assigned to one of four study conditions: iptg, vhutshilo, iptg+vhutshilo, and control. approximately 1600 adolescent ovc aged 14-17 years (current beneficiaries at the drop-in centers) and their caregivers were eligible to participate in the study at baseline. participants were visited three times including the baseline survey. follow-up data collection was conducted in two rounds. the first round took place 8 months after the baseline survey and immediately following intervention exposure. a second follow-up round took place a year later, allowing assessment of both the immediate and longer-term impact of the interventions. participants were interviewed at home in xhosa or sesotho. caregivers in the sample completed face-to-face interviews with trained interviewers, while adolescents complete surveys used a mix of face-to-face interviewing and audio computer-assisted self-interview technology (acasi).

Eligibility criteria:
inclusion criteria: * aged 14-17 years old as of january 1, 2012; * enrolled in a selected world vision site; * willing and able to assent to study participation; and * consent given by the parent or guardian for the adolescent to participate in the study. exclusion criteria: * are not able to give informed assent due to known or recognizable cognitive or psychiatric impairment.

Keywords: orphans and vulnerable children (ovc) program evaluation hiv prevention psychosocial wellbeing adolescents
multivitamin dosage regimens in the prevention of adverse pregnancy outcomes among hiv-positive women

Conditions: HIV Infections

Summary: the purpose of this study is to examine effects of daily administration of multivitamin supplements at doses resembling the recommended dietary allowance (rda) during pregnancy to hiv positive women decreases the risks of low birth weight (\<2500 g), and pre-term birth (\< 37 weeks gestation), compared to multivitamin supplements at doses above the rda.

this is a randomized clinical trial conducted to examine effects of daily administration of multivitamin supplements at doses resembling the recommended dietary allowance (rda) during pregnancy to hiv positive women decreases the risks of low birth weight (\<2500 g), and pre-term birth (\< 37 weeks gestation), compared to multivitamin supplements at doses above the rda. all women receive standard prenatal care, including nevirapine for the prevention of mother-to-child transmission of hiv.

Eligibility criteria:
inclusion criteria: - hiv-positive pregnant women who are between 12 and 27 weeks gestation who intend to stay in dar es salaam until delivery.

Keywords: hiv aids multivitamins pregnancy outcomes women tanzania africa
a comparison of solid and soluble forms of cold and influenza remedies

Conditions: Influenza; Common Cold

Summary: the study is designed to investigate whether paracetamol from a hot remedy reaches the plasma faster than standard paracetamol tablets. the study will also assess the gastrointestinal transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. it is postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a greater early exposure compared to standard paracetamol tablets. in addition, the pharmacokinetic (pk) profile of paracetamol in the two formulations will be investigated.


Eligibility criteria:
* healthy male volunteers * body mass index between 18.0-29.9 kg/m\^2
a pharmacokinetic study of a single-dose of diazepam nasal spray in adult epileptic patients experiencing a seizure episode

Conditions: Epilepsy

Summary: the purpose of this study is to determine the pharmacokinetics of diazepam nasal spray following a single dose in epileptic patients experiencing a seizure episode.


Eligibility criteria:
inclusion criteria: * provide signed informed consent for study participation. * general good health with no clinically significant unstable abnormalities. * diagnosis of epilepsy. exclusion criteria: * individuals receiving warfarin (coumadin®) or dabigatran (pradaxa®). * use of any investigational drug within 30 days. * blood or plasma donation within 30 days. * not willing or unable to tolerate blood draws.
the effect of plant sterols on vascular function

Conditions: Vascular Diseases; Hypercholesterolemia

Summary: the main aim of the study is to investigate, in humans, the effect of plant sterols on vascular function by measuring flow-mediated dilation (fmd). this study also aims to study the effect of plant sterols on pulse wave velocity (pwv), aortic augmentation index (aix), central blood pressure (cbp), office blood pressure (bp), blood lipids and plasma plant sterol concentration. at last, the effects of plant sterols on z-scores of circulating biomarkers of endothelial dysfunction and low-grade inflammation will be assessed. for all study outcomes, effect sizes and 95% confidence intervals will be estimated. hypothesis: based on available evidence, it is hypothesized that plant sterols modestly increase fmd.

plant sterols are well known for their ldl-cholesterol lowering benefit. elevated cholesterol and especially ldl-cholesterol concentrations are established risk factors for coronary heart disease (chd) and reducing these concentrations by dietary modification or drug treatment have been shown to reduce the risk of chd. direct evidence supporting a reduced risk of chd has so far not been generated. investigating the effects of consuming plant sterols on intermediate risk factors beyond cholesterol-lowering is therefore warranted.

Eligibility criteria:
inclusion criteria: * apparently healthy men and post-menopausal women * bmi ≥ 18 and ≤ 30 kg/m2. * aged between 40 - 65 years. * having elevated ldl-cholesterol concentrations at screening (130-190 mg/dl or 3.4-4.9 mmol/l). * blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the research physician exclusion criteria: * having (previous) cardiovascular event(s) (stroke, tia, angina, myocardial infarction, heart failure), systemic inflammatory conditions or diabetes mellitus. * use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, arb and ace inhibitors), to be judged by the principal investigator. * use of medical treatment for elevated tg concentrations. * use of antibiotics in the three months prior to screening. * currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.

Keywords: vascular function plant sterols blood lipids
waist circumference versus body mass index to predict severity of gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease; Obesity

Summary: gastroesophageal reflux disease (gerd) is a common and important disorder. previous studies have demonstrated the association of obesity with gerd, and now obesity is regarded as a risk factor for gerd. moreover, body mass index (bmi), an indicator of general obesity, correlates with severity of symptoms and degree of erosive esophagitis. waist circumference, an indicator of abdominal obesity, has stronger correlation with intra-abdominal pressure and low-grade inflammatory state when compared with bmi. nevertheless the association of waist circumference with severity of gerd has not been studied. the primary aim of this study is to compare bmi with waist circumference for their independent association with severity of gerd. the secondary aim is to evaluate independent risk factors of severity of gerd.

this is a cross-section observational study. outpatients presenting with acid reflux or heart burn are interviewed with standardized questionnaire to quantify severity of symptoms. the eligible patients undergo upper endoscopy to diagnose erosive esophagitis and further classify the degree of erosions according to los-angels classification. enrolled patients receive anthropometric measurements to record body weight, body height and waist circumference on the day of enrollment. two outcomes are studied: the severity of gerd symptoms and the los-angels classification of erosive esophagitis.

Eligibility criteria:
inclusion criteria: * age more than 20 years old and less than 70 years old * typical gastroesophageal reflux symptoms (heart burn and acid reflux) * outpatient * complete upper gastrointestinal endoscopy exclusion criteria: * age less than 20 years or more than 70 years old * receive medication for reflux disease (including proton pump inhibitor, histamine type 2 receptor blocker, prokinetic agents) in previous one month * pregnant women * history of abdominal surgery * severe comorbidity with cirrhosis, end-stage renal disease, heart failure * no written informed consent

Keywords: gastroesophageal reflux disease waist circumference body mass index obesity