Kornimate/medical-research-clean huggingface dataset:
effect of different doses of tomato lycopene on blood pressure in pre-hypertensive otherwise healthy subjects

Conditions: Hypertension

Summary: effect of different doses of tomato extract (contain lyc-o-mato 6% oleoresin which contain: 5, 15 mg lycopene , in addition to beta-carotene (0.15%), phytoene, and phytofluene (1%); and vitamin e (2%), phospholipids (15%), and phytosterols (0.6%) suspended in tomato oleoresin oil) compared with synthetic lycopene on blood pressure and plasma lycopene levels in never treated pre-hypertensive otherwise healthy subjects.


Eligibility criteria:
inclusion criteria: * aged 35-60, * no antihypertensive treatment in the past or present, * 135\< sbp\< 145 or 85\<dbp\<95, * informed consent signed, exclusion criteria: * unwilling to participate in the study, * treated essential, * secondary or complicated hypertension, * sbp lower than 135 or higher than 145 mmhg, * dbp lower than 85 or higher than 95 mmhg, * use of other medications (statins, nsai ect..), * known allergy to tomato, carotenoids, or vitamin e, * diabetes mellitus, * obesity bmi\>32, * significant dyslipidemia, * patients with ischemic pain, s/p mi, ptca or cabg, lvh or chf, * smoker, * valvular heart disease, * pvd, * cerebrovascular disease, s/p cva, tia, * any kind of kidney disease (creatinine\>1.6), * chronic liver disease(elevated ast and alt at least by 2 times of the normal range), * alcohol abuse, * history of gi disease or surgery, * history of malignancy in the past 5 years, * history of autoimmune disease, * participation in other researches protocol
evaluating expectancy effects in weight loss measurement

Conditions: Accuracy of Clinic-based Weight Measurements

Summary: the purpose of this project is to examine potential bias or expectancies in individuals' measurement and recording of weight in a clinical-research setting.


Eligibility criteria:
inclusion criteria: * 19+ years-old * available to attend clinic sessions on dates provided for data collection exclusion criteria: * younger than 19 years * not available on specified dates of data collection
efficacy of only iv artesunate versus iv artesunate plus iv quinine in the treatment of severe malaria in children: a comparative study

Conditions: Malaria

Summary: the who recommends artesunate as the drug of choice for the treatment of severe malaria. however, the efficacy of this single drug as compared to the combined drug regimen remained questionable, and the clinical response was considered delayed or inappropriate. therefore, this research intended to evaluate the efficacy of only iv artesunate versus iv artesunate plus iv quinine in the treatment of severe malaria in children. the findings of the study would be helpful knowing whether the two drugs, when given together, have considerable benefit over single-drug therapy when given for the same.


Eligibility criteria:
inclusion criteria: children admitted to the emergency department with the diagnosis of severe malaria. exclusion criteria: children with chronic kidney disease, chronic liver disease, immunosuppressive disorders, hematological disorders, malignancies, and congenital heart disease.
effect of hydrocortisone on improving outcome of pneumatic reduction of infantile intussusception

Conditions: Intussusception

Summary: intussusception is one of the most frequent causes of acute bowel and second most common cause of acute abdominal pain in pediatric age .95 % of cases are idiopathic, the rest are either due to pathological lead point or post operative. treatment of intussusception must start with medical resuscitation, then radiological or operative reduction of intussusception. our surgery team has used hydrocortisone with the medical resuscitation to improve the success rate of pneumatic reduction and decrease the number of reduction trials.

experimental group will be given single dose iv hydrocortisone 10 mg/kg with resuscitation before attempting first trial of pneumatic reduction and the outcome measured. control group will be given saline 100 ml iv single injection with resuscitation before attempting first trial of pneumatic reduction and the outcome measured.

Eligibility criteria:
inclusion criteria: * infantile intussusception exclusion criteria: * peritonitis pneumoperitoneum morbid patients

Keywords: intussusception
safety and efficacy of exubera compared with subcutaneous human insulin therapy in children and adolescents

Conditions: Diabetes Mellitus, Type 1

Summary: to assess the safety and efficacy of exubera on pulmonary function and glycemic control in subjects ages 6-17 over a 1 year period.

pfizer announced in october 2007 that it would stop marketing exubera. at that time recruitment for the pediatric study, a2171083, was placed on hold. two subjects completed the informed consent/assent process and entered the a2171083 study but none received treatment. the first subject withdrew consent during the baseline run-in period which was prior to randomization. the second subject screen failed at visit 1. after this time, nektar, the company from which pfizer licensed exubera, announced on april 9, 2008 that it had stopped its search for a new marketing partner. accordingly, there will be no commercial availability of exubera. as a result, study a2171083 was terminated and no further recruitment took place.

Eligibility criteria:
inclusion criteria: * subjects with type 1 diabetes mellitus for more than 6 months. * males and females ages 6 to 17 years. * subjects should be receiving, or be able to tolerate, at a minimum a 3 unit pre prandial dose of short acting subcutaneous insulin. exclusion criteria: * subjects using an insulin pump * smoking
long-term outcome after isolated tricuspid valve repair

Conditions: Tricuspid Valve Insufficiency

Summary: tricuspid valve insufficiency (ti) is often noted on echocardiography. although severe ti is known to cause significant morbidity and mortality, no good guidelines are available to guide intervention. literature is mostly confined to tricuspid valve repair concomitant with mitral valve repair. treatment options for isolated repair have not been investigated thoroughly. the investigators want to evaluate retrospectively the outcome of isolated tricuspid valve repair, performed in our center. by doing this, the investigators want to evaluate predictors of outcome after repair.


Eligibility criteria:
inclusion criteria: * tricuspid valve insufficiency exclusion criteria: * younger than 18 years * associated valvular surgery
antiseptic use and dressing application

Conditions: Skin Colonization; Catheterization; Bacterial Infection

Summary: the purposes of the study are: 1. to compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (epi). 2. to evaluate whether the bacteria responsible for nosocomial infection is comparable to the flora diagnosed at the epi site.

epicutaneocavous catheter is a significant risk factor for nosocomial infection in newborn infants. these infections have been related to local bacterial colonisation. therefore thorough disinfection should lower the risk of nosocomial infection. however, the local efficacy of antiseptic use has not yet been clearly evaluated in this situation.

Eligibility criteria:
inclusion criteria: * all infants admitted to the neonatal intensive care unit * epicutaneocavous catheter insertion indication exclusion criteria: * epicutaneocavous catheter not inserted within the unit

Keywords: skin colonization antiseptic epicutaneocavous catheter dressing infant
comparison of microwave ablation-assisted enucleation and conventional laparoscopic partial nephrectomy in the treatment of t1a renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of t1a renal cell carcinoma.

microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. this study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with conventional laparoscopic partial nephrectomy.

Eligibility criteria:
inclusion criteria: * patients with sporadic, unilateral, newly diagnosed t1a presumed renal cell carcinoma * exophytic cancer * distance from the hilar renal vessels and urinary collecting system \>= 1cm * patients with normal contralateral renal function (differential renal function of \>40% as determined by renal scintigraphy) * patients giving consent to the participation in the current clinical trial exclusion criteria: * patients with a history of other renal diseases, such as urinary lithiasis * patients with a history of renal surgery

Keywords: zero ischemia microwave ablation enucleation renal cell carcinoma
study to evaluate the efficacy and safety of dimethyl fumarate (tecfidera) and peginterferon beta-1a (plegridy) for the treatment of relapsing-remitting multiple sclerosis in pediatric participants

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the main objective of the study is to evaluate the efficacy of dimethyl fumarate (tecfidera) and peginterferon beta-1a (plegridy), both compared with placebo, in pediatric participants with rrms. the other objectives of this study are to evaluate the safety and tolerability of dimethyl fumarate and peginterferon beta-1a and to assess the effect of dimethyl fumarate and peginterferon beta-1a, both compared with placebo, on additional clinical and radiological measures of disease activity.

participants will be randomized in a 1:2:2 ratio to receive the double-blind study treatment (dimethyl fumarate, peginterferon beta-1a, and placebo). participants experiencing a confirmed relapse or disability progression or high lesion burden on mri will have the option to discontinue the blinded study treatment and switch to an alternative therapy or open-label bg00012.

Eligibility criteria:
key inclusion criteria: * must have a diagnosis of rrms as defined by the revised consensus definition for pediatric ms * must have an edss score between 0.0 and 5.0. * must have a body weight of ≥30 kg * must have experienced ≥1 relapse in the 12 months prior to randomization (day 1), or must have evidence of asymptomatic disease activity seen on mri in the 6 months prior to randomization, or ≥2 relapses in the 24 months prior to randomization (day 1). relapse is defined as the occurrence of a clinical demyelination event regardless of whether the event is a first or subsequent demyelinating event. key exclusion criteria: * participants having primary progressive, secondary progressive, or progressive rms. * disorders mimicking ms, such as other demyelinating disorders, systemic autoimmune disorders, metabolic disorders, and infectious disorders. * history of clinically significant cardiovascular, pulmonary, gi, hepatic, renal, endocrinologic, hematologic, immunologic, metabolic, dermatologic, growth, developmental, psychiatric (including depression), neurologic (other than ms), and/or other major disease and/or laboratory abnormality indicative thereof, that would preclude participation in a clinical study * occurrence of an ms relapse within the 30 days prior to randomization (day 1) and/or the subject has not stabilized from a previous relapse prior to randomization note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: pediatric, multiple sclerosis
cost-effectiveness of topical fluoride in preventing deciduous dental caries in preschool children

Conditions: Dental Caries in Children

Summary: fluoride foam and fluoride varnish are effectiveness in prevention deciduous dental caries. however, the relative clinical efficacy and cost-effectiveness of these two interventions are uncertain. this study aims to evaluate the relative clinical effectiveness and cost-effectiveness of fluoride foam and fluoride varnish in preventing dental caries in the primary teeth of preschool children with high caries risk.

this 24-month randomized clinical trial aims to compare the clinical efficacy and cost-effectiveness of topical fluoride application of fluoride foam and fluoride varnish in preventing dental caries in the primary teeth of preschool children with high caries risk in harbin,heilongjiang province,china. preschool children (3-4 years) with high caries risk will be invited to participant in this study. an invitation letter will be sent to the parents explaining the purpose and procedures of this study.parental concent will be sought. the children will be randomly divided into three groups: the control group-no intervention; the intervention group 1 - applications of 1.23% fluoride foam every 6 months; the intervention group 2- applications of 2.26% fluoride varnish every 6 months. dental clinical examination of the children will be performed at the beginning of the study,12 months and 24 months later.the dental examiners will receive unified training and consistency test of dental caries survey.only when the kappa value reached 0.8 can oral examiners participate in the oral examination.dental caries condition will be recorded. approximately 5% of children will be re-examined to determine the reliability of the results. the status of any possible side/adverse effects will be recorded in the follow-up examinations. the data of the study will be analysed by spss statistical analysis software.the differences among the groups will be calculated and compared. and p\<0.05 will be considered statistically significant.

Eligibility criteria:
kindergartens inclusion criteria: * kindergartens which are all located in harbin, heilongjiang province, china; * kindergartens which are basically the same in terms of school scale, student source structure, economic level and sanitary conditions; * kindergartens with the same source of domestic water, or with the same fluoride concentration in water , and the fluoride concentration in water less than 1.0mg/l. children inclusion criteria: * children aged over 3-year and under 4-year at the time of the survey; * children in good health; * children with a certain degree of understanding and good compliance; * children whose parents sign the informed consent form. exclusion criteria: * children who are unable to cooperate or have a strong vomiting reflex; * children with a history of asthma or allergies; * children with other contraindications specified in the product manual.

Keywords: cost effectiveness fluoride foam fluoride varnish dental caries clinical trial
open-label extension of the pti-125-04 study in mild-to-moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is a 96-week extension study of open-label simufilam 100 mg b.i.d. for mild-to-moderate alzheimer's disease subjects who completed the phase 2 study, pti-125-04. the study will evaluate safety and long-term treatment. safety will be assessed by ae monitoring, clinical labs, urinalysis, vital signs, ecgs, and c-ssrs.

this is an open-label 96-week extension study of open-label simufilam 100 mg b.i.d. for subjects who completed the phase 2 study, pti-125-04. all subjects will provide consent to enroll into this study. simufilam will be administered as coated oral tablets. the last study visit, month 24, from the pti-125-04 study will be used for the study day 1 visit assessments in this extension study. clinic visits will occur every 12 weeks ±10 days. a complete physical examination will be performed at study day 1, week 48 and week 96. subjects will return to the clinic every 12 weeks for safety assessments of vital signs, ae monitoring, c-ssrs, and drug dispensation and accountability. blood draws for clinical laboratory testing, urine collection for urinalysis, and ecgs will be performed at study day 1 and weeks 24, 48, 72, and 96. safety will be evaluated by adverse event monitoring, vital signs, clinical labs, and the columbia suicide severity rating scale (c-ssrs).

Eligibility criteria:
• subjects must have completed the pti-125-04 study.
he-move-philia, lifestyle intervention for patients with hemophilia

Conditions: Hemophilia

Summary: the main objectives are reduction of body weight, bmi and abdominal circumference. secondary objectives are reduction of bleeds and units coagulation factor concentrate used, blood-pressure, cholesterol spectrum, glucose and improvement of physical activity and dietary habits. one group of patients will receive a combined lifestyle intervention program with individual sessions and group sessions lasting for 2 years, the other group of patients will receive individual sessions only and will be given the same information as given in the group sessions, but on paper.

the prevalence of overweight and obesity is increasing in patients with hemophilia and other bleeding disorders. in these patients physical activity is often difficult due to arthropathy as a result of intra-articular bleeding in the past, with decreased joint movement and pain and the fear of new bleeds. this enhances weight gain, increases pressure on joints, leading to more bleeds and more arthropathy. in the long term overweight and obesity increases risk of cardiovascular diseases, with the concomitant need for anticoagulant therapy, which further enhances the bleeding risk in these patients. the aim of this exploratory study is to compare the effect of a lifestyle intervention program consisting of combined individual coaching and group sessions (cli) with a lifestyle intervention program with individual coaching only (ii).the program is especially designed for patients with a bleeding disorder. the investigators hypothesize that body weight, bmi, abdominal circumference, bleeds and units coagulation factor concentrate, as these are dosed on body weight, will decrease in both groups, but more in the cli with group sessions.

Eligibility criteria:
inclusion criteria * diagnosed with hemophilia a, b, fvii deficiency, fibrinogen deficiency, von willebrand disease or other bleeding disorder preferably requiring coagulation products for prophylaxis or on demand in case of bleeding * ≥ 18 years of age * bmi ≥ 30 kg/m2 * motivated to change their lifestyle * being able to speak, read and understand the dutch language exclusion criteria * health care insurance with cz or onvz as these health insurances have no contract with profitt lifestylecoaching. * a contraindication or inability for physical activity as judged by the treating hemophilia physician * participation in another research trial * unable to understand the written information * unable to sign the informed consent * unwilling to randomize to the combined or individual intervention group
identification of patients at risk of chronic back pain using questionnaires

Conditions: Back Pain

Summary: patients with acute back pain (\<6 weeks) presenting at their general practitioner will be enrolled. patients fulfilling all inclusion criteria and showing no exclusion criteria will fill out the heidelberg short questionnaire (hkf-r10) and the keele start back screening tool. these two questionnaires categorize back pain patients into individuals at risk of chronic back pain and those not at risk. furthermore, data concerning pain location, severity, duration and impairment will be collected. study participants will receive standard care treatment prescribed by their general practitioner. six months later, study participants will receive a questionnaire in order to collect data concerning their present pain situation. patients with relevant impairment in their activities of daily living as a result of back pain will be categorized as individuals with chronic back pain. categorization at six months will be compared with the categorization at presentation.


Eligibility criteria:
inclusion criteria: * acute (\<6 weeks) back pain * \>20 und \<60 years of age * good oral and written knowledge of german language exclusion criteria: * any treatment for back pain within the last 6 months * cauda equina * tumor * generalized pain * severe systemic illness * substance abuse * pregnancy
new echocardiographic parameters for assessment of longitudinal left ventricular function

Conditions: Cardiovascular Pathology

Summary: assessment of left ventricular systolic function is the most frequent indication for routine echocardiography. qualitative eyeball method and biplane modified simpson's rule, both measuring radial ventricular function, are the currently recommended methods to meet this challenge. due to the complexity of the myocardial architecture, global left ventricular function also has longitudinal and torsional components. the aim of this study is to evaluate new echocardiographic parameters for longitudinal left ventricular function. a special focus is set on strain imaging by speckle tracking, which is a relatively new technique. patients with different cardiac pathologies (e. g. dilated cardiomyopathy, coronary artery disease, diastolic dysfunction) will be included and compared to healthy individuals.


Eligibility criteria:
inclusion criteria: * persons of 18 years and older who receive a transthoracic echocardiography at our department * written consent exclusion criteria: * permanent pacemaker rhythm * moderate/severe valvular heart disease

Keywords: echocardiography strain imaging ventricular dysfunction cardiomyopathy longitudinal left ventricular function
the role of bifidobacterium intervention in food allergic infants

Conditions: Food Allergy in Infants

Summary: infant food protein allergy is the most common allergic disease in children, which can lead to infantile-specific dermatitis, intestinal inflammation, and so on. dietary avoidance is a common strategy for food protein allergy in infants and young children. however, the hidden etiology of food protein allergy or multiple food allergies often leads to poor efficacy. the aim of this study is to observe the clinical effectiveness of bifidobacterium intervention on food allergy.


Eligibility criteria:
inclusion criteria: * 0 -12 months infant * infants that are allergic (confirmed by an allergist) to at least one of the main food allergens (cow's milk, egg, soy or wheat) and is following an elimination diet to at least one of these allergens. exclusion criteria: * patients had used probiotics within 1 month prior to the study * allergy or intolerance to probiotics or their excipient * serious primary diseases of the cardiovascular, nervous, respiratory,hepatobiliary immunology，and endocrine systems;