Kornimate/medical-research-clean huggingface dataset:
high strength cranberry supplementation for prevention of recurrent urinary tract infection

Conditions: Urinary Tract Infection

Summary: this clinical trial is a phase 2, multicenter, placebo-controlled, double-blind, parallel-arm study to evaluate the efficacy and safety of high strength cranberry (500mg pacran®) in preventing uti (cystitis) in women with a history of recurrent uti (ruti).


Eligibility criteria:
inclusion criteria: 1. females aged 18-65 years, inclusive 2. a history of recurrent urinary tract infection defined as ≥3 utis in the last year or at least 2 utis occurring in the last 6 months. each infection requires confirmation by a health professional 3. willing to answer questionnaires and comply with the study requirements 4. ability to swallow capsules 5. provided written informed consent 6. bmi \>17.5kg m2 and \<35kg m2 exclusion criteria: 1. microbial growth on urine culture of ≥107 cfu/l (104cfu/ml) within 7 days of day 1 2. a history of \>5 utis in the last 6 months (confirmed by self-report or health professional) 3. use of antibiotics or antibiotics for prophylaxis within 28 days of day 1 4. use of any antibacterial products, that in the opinion of the medical investigator may interfere with the study outcomes, within 28 days of day 1 5. regular use of vaccinium containing products (e.g. all forms of blueberries, cranberries, bilberry, lingonberry , etc i.e fruit, dried fruit, pills, juices or supplements) within 28 days of day 1 at the discretion of the medical investigator 6. presence of an intermittent or indwelling urinary catheter 7. anatomical abnormalities of the urinary tract 8. history of or known clinically significant renal or urological disease(self-reported) 9. positive urine dipstick pregnancy test at screening onday 1, currently pregnant and/or breastfeeding 10. women of childbearing potential not willing to use adequate and effective methods of contraception throughout the study 11. women of child bearing potential that have not been using effective methods of contraception for 14 days prior to day 1 12. history of or known clinically significant cardiac disease 13. history of or known clinically significant liver disease 14. history of or known clinically significant gastrointestinal disease 15. history of or known metabolic disorder or diabetes 16. history or presence of alcohol or illicit drug abuse,any surgical history, clinical condition or organ dysfunction that in the opinion of the medical investigator may affect the participant's ability to participate in the study or the study results 17. currently hospitalised or any planned hospitalisations within 1 month following the last dose of study product 18. immunocompromised participants or participants receiving immunosuppressive medication 19. history of an adverse reaction or known hypersensitivity or suspected allergy to the investigational product ingredients 20. currently taking warfarin or has received warfarin within 28 days of day 1 21. received an investigational drug within 28 days of day 1

Keywords: recurrent
the "cad-man" extend study

Conditions: Coronary Artery Disease

Summary: cad-man extend is the long-term follow-up (clinical, laboratory, and computed tomography (ct) imaging) of a single-center, randomized, controlled cad-man trial comparing a ct-first strategy with a direct- invasive coronary angiography (ica) diagnostic and management strategy, in 329 patients clinically referred for ica with atypical angina or chest pain. overall goal: the extension of cad-man follow-up (clinical, laboratory, and ct imaging) to approximately 10 years will provide the opportunity to compare plaque burden with ct-guided management versus direct-ica at long-term and other endpoints.

the cad-man (coronary artery disease management with multislice computed tomography and magnetic resonance imaging in patients with atypical angina pectoris) trial evaluated whether computed tomography (ct) or invasive coronary angiography (ica) should be performed in patients clinically referred for coronary angiography with an intermediate probability of coronary artery disease. patients with suspected cad were randomized 1:1 ratio to ct, followed by ica if positive for obstructive cad, or to direct ica. in both tests, obstructive cad was defined as at least a 50% diameter stenosis in the left main coronary artery or at least a 70% diameter stenosis in other coronary arteries. investigators and participants were blinded to randomization sequence but could not be blinded to the assigned group because of the apparent differences between ct and ica. independent investigators, who were blinded to the randomization group and were not part of the study team, anonymously assessed outcomes. results on the comparative effectiveness of ct and ica in preventing the primary outcome of major procedural complications within 48 hours of the last procedure and major adverse events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) were published for a median follow-up of 3.3 years. the primary results and additional subgroup analyses of the cad-man trial led to three new hypotheses that will be evaluated in the cad-man extend study. 1. main hypothesis: whether ct-guided management of patients with atypical angina results in a reduction in coronary plaque burden (as determined by repeat ct scan) compared with direct-ica management until 10 years. 2. secondary hypothesis: 1. whether clinical characteristics or blood levels and lipid-lowering medications have an impact on intraindividual progression of coronary plaques in patients in the ct group. 2. whether primary ct examination in patients with atypical angina leads to a reduction in chronic impairment of renal function after 10-years compared with initial ica examination.

Eligibility criteria:
inclusion criteria: * patients with suspected cad * patients with atypical angina * patients who have previously participated in the cad-man study and have not died at a median follow-up of 3.3 years. exclusion criteria: exclusion criteria for additional ct scan: * pregnancy * any health condition that would cause concern that participation would not be in the best interest of health (eg, extensive comorbidities)
assessment of vertical root fracture resistance of endodontically treated teeth instrumented by single endodontic files

Conditions: Vertical Fracture of Root of Tooth (Disorder)

Summary: the purpose of this study is the assessment of vertical root fracture resistance of roots prepared with three different single endodontic rotary files in extracted human mandibular premolar roots.

88 human extracted mandibular premolars will be selected. teeth will be sectioned below cementoenamel junction to get 13mm from the apex of root. roots will then be standardized according to buccolingual and mesiodistal widths and will be examined for fracture and craze lines. the roots will then be randomly divided into 3 experimental groups and 1 control group (n=22). group 1 will be instrumented with hyflex edm. group 2 will be instrumented with f6 sky taper. group 3 will be instrumented with one shape and group 4 will be negative control group in which no instrumentation will be done. after performing rotary instrumentation, roots will then be obturated with respective gp and sealer. samples will then be exposed to vertical load utilizing universal testing machine till fracture occur which will be recorded in newton(n).

Eligibility criteria:
inclusion criteria: * extracted human mandibular premolar canals that fulfill the following criteria were used. * permanent teeth * intact and fully formed apices * straight and single rooted canal * roots having similar diameter mesiodistally(2-4mm) and buccolingually(4-6mm) exclusion criteria: * roots having following features were excluded; * root caries * roots with multiple canals * previous root canal treatment done * signs of calcification, internal and external root resorption * cracks * fracture lines * c-shaped canals * vertical root fracture

Keywords: hyflex edm,f6 sky taper,one shape
assessment of safety and efficacy of therapy for the prevention of weight gain associated with olanzapine

Conditions: Schizophrenia; Schizoaffective Disorders

Summary: the goal of this study is to answer the following questions: * whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine * whether taking amantadine, metformin or zonisamide can help patients decrease or eliminate some of the changes in body that occur with weight gain * how weight gain associated with olanzapine can affect people * whether treatment with amantadine, metformin or zonisamide can help eliminate weight gain associated with olanzapine and not interfere with the positive effects of olanzapine on functioning of people with schizophrenia and other diseases


Eligibility criteria:
inclusion criteria: * you must have been diagnosed with schizophrenia or schizoaffective disorder * you must be able to visit the doctor's office once every two weeks for three months, then once every four weeks for the next three months with a possible bi-weekly visit during the fifth month * if you are currently taking a medication for schizophrenia or schizoaffective disorder, you have been taking it for at least 30 days without any changes * if you are a female, you must have a negative pregnancy test and be using an effective method of contraception exclusion criteria: * you have a diagnosis of bipolar i disorder, diabetes, very high triglyceride level (fasting triglycerides greater than or equal to 500 mg/dl), recent heart attack, stroke, uncontrolled seizures, serious infection, unstable heart disease (such as ischemic heart disease or congestive heart failure), an uncorrected narrow angle glaucoma or human immunodeficiency virus (hiv) * you have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood * you have a diagnosis of an eating disorder * you have a history of parkinson's disease or any related disorders * you are allergic to sulfa drugs or any of the medications involved in this study
a study of metronidazole cream in the prevention and treatment of tarceva (erlotinib)-associated rash

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this study will evaluate the efficacy and safety of metronidazole actavis 1 percent (%) topical cream in the prevention and treatment of rash associated with tarceva treatment, in participants with non-small cell lung cancer. the first cohort of participants enrolled in the study will be treated twice daily with metronidazole cream on the right side of the face and upper thorax, the same day as they start treatment with tarceva (150 mg orally daily). the corresponding body parts on the left side will be treated according to local standard procedures (ie, with non-active moisturizing cream). the second cohort of tarceva-treated participants will only receive twice daily treatment with metronidazole cream if and when they develop rash. in both cohorts, efficacy will be evaluated at week 2 and week 4. the anticipated time on metronidazole treatment is less than (\<) 3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * non-small cell lung cancer * eligible to start treatment with erlotinib exclusion criteria: * hypersensitivity to metronidazole
jardiance® post marketing surveillance (pms) in korean patients with chronic heart failure

Conditions: Heart Failure

Summary: the primary objective of this study is to monitor the safety profile of jardiance® in korean patient with chronic heart failure (new york heart association (nyha) class ii-iv) in a routine clinical setting.


Eligibility criteria:
inclusion criteria: * patients who have started at first time on jardiance® in accordance with the approved label in korea for heart failure (hf) * chronic heart failure (new york heart association (nyha) class ii-iv) * age ≥ 19 years at enrolment * patients who have signed on the data release consent form exclusion criteria: * patients with previous exposure to jardiance® * known allergy or hypersensitivity to active ingredients empagliflozin or to any of the excipients * patients with type 1 diabetes or with prior history of diabetic ketoacidosis (dka) * patient with renal impairment with estimated glomerular filtration rate (egfr) \< 20 ml/min/1.73 m² * patients with rare hereditary conditions of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption * patient who are pregnant or are nursing or who plan to become pregnant while in the trial * patients for whom empagliflozin is contraindicated according local label of jardiance®
whole body vibration in chronic obstructive pulmonary disease

Conditions: COPD

Summary: the investigators designed the current study with the main objective of determining whether whole body vibration training (wbvt) alone improves muscular force and/or modifies the functional capacity parameters in severe chronic obstructive pulmonary disease (copd) patients referred to a rehabilitation programme.


Eligibility criteria:
inclusion criteria: * severe copd defined as a post-bronchodilator forced expiratory volume at one second (fev1)/ forced vital capacity (fvc) \< 0.7 and fev1 \< 50% predicted, * stable disease defined as no exacerbation, * hospital admission or change in treatment in the previous 3 months. exclusion criteria: * other significant respiratory disease (bronchiectasis, * lung fibrosis, asthma, etc), * active smoking, * severe cardiovascular, * neurological, and/or metabolic pathology that could interfere with the results, * total hip, knee or ankle arthroplasty, * previous vitreous haemorrhage, * severe alcoholism (\> 80 g/day) and * severe malnutrition (bmi \< 19 kg/m2) to reduce the risk of falling and dropouts.
electronic cigarette use during pregnancy

Conditions: Cigarette Smoking-Related Carcinoma

Summary: aim 1: to compare the overall toxicant exposure in pregnant women who use electronic cigarettes (e-cigs, vapor, e-liquid, e-juice, vape, vaping devices) compared to women who smoke conventional cigarettes. aim 2. to compare toxicant exposure and birth outcomes among infants born to pregnant women who use e-cigs compared to women who smoke conventional cigarettes. aim 3. to explore potential mechanisms by which e-cigs could influence birth weight.

in addition to examining characteristics of pregnant e-cig users as well as patterns of their product use, this study is innovative in several ways. first, it is the first known study to examine toxicant exposure to cigarettes and e-cigs in a sample of pregnant smokers who are using these products. although studies have reported on toxic exposures with e-cigs, this is the first study to apply toxic exposure tests to pregnant women. second this is the first study to examine the impact of electronic cigarette use on birth outcomes in pregnant smokers. although e-cigarettes are similar to tobacco cigarettes in that they deliver nicotine, they are distinguished from tobacco cigarettes in that they do not contain many toxic substances such as carbon monoxide and volatile organic compounds. consequently, similar to nicotine replacement therapies they have the potential to improve birth outcomes. however, it possible that there may be unanticipated negative effects on birth outcomes, and this study could provide a signal for potential other adverse effects (i.e., miscarriages etc.). third, this study is the first to examine whether e-cigs alter carcinogen exposure to the fetus, which has been implicated in causing low birth weight and in long-term cancer risk for infants born to smokers. finally, this is the first study to explore formaldehyde in urine as a measurement of conventional smoking and electronic cigarette use.

Eligibility criteria:
inclusion criteria: 1. cigarette smokers who exclusively smoke conventional cigarettes daily, or who use e-cigs daily, or who use either product daily and the other product at least weekly. 2. participant is ≤ 24 weeks gestation for conventional smokers and ≤ 36 weeks gestation for e-cig users or dual users. 3. at least 16 years of age 4. able to speak english or spanish; 5. able to read and sign consent form 6. intent to carry pregnancy to term. exclusion criteria: 1. current drug or alcohol abuse or dependence (other than methadone or buprenorphine maintenance) 2. participant uses combustible marijuana more than 3 times per week (use of edibles/oils is permitted 3. unstable psychiatric disorder 4. unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum) 5. known congenital abnormality 6. regular use of tobacco products other than conventional or e-cigs

Keywords: nicotine nicotine addiction tobacco use disorder pregnancy electronic cigarettes cigarettes vaping carcinoma pregnant birth outcomes e-liquid
naxitamab for high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow

Conditions: Neuroblastoma

Summary: children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (gm-csf). patients will be followed for up to five years after first dose. naxitamab, also known as hu3f8 is a humanised monoclonal antibody targeting gd2

each patient will receive treatment for up to 101 weeks following the first naxitamab administration. after the end of trial visit, each patient will enter a long-term follow-up where they will be monitored for up to 5 years after first treatment cycle. each investigational cycle is started with 5 days, days -4 to 0, of granulocyte-macrophage colony stimulating factor (gm-csf) administered at 250 µg/m2/day in advance of the start of naxitamab administration. gm-csf is thereafter administered at 500 µg/m2/day on days 1 to 5. as standard treatment, naxitamab is administered at 3 mg/kg/day on days 1, 3, and 5, totalling 9 mg/kg per cycle. treatment cycles are repeated every 4 weeks (±1 week) until complete response or partial response followed by 5 additional cycles every 4 weeks (±1 week). subsequent cycles are repeated every 8 weeks (±2 weeks) through 101 weeks from first infusion at the discretion of the investigator. end of treatment will take place around 8 weeks after the last cycle and thereafter long-term follow-up will continue.

Eligibility criteria:
inclusion criteria: * diagnosis of neuroblastoma as defined per international neuroblastoma response criteria * high-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment (in both cases including stable disease, minor response and partial response) evaluable in bone and/or bone marrow. * life expectancy ≥ 6 months exclusion criteria: * any systemic anti-cancer therapy, including chemotherapy or immunotherapy, within 3 weeks before 1st dose of gm-csf * evaluable neuroblastoma outside bone and bone marrow * existing major organ dysfunction \> grade 2, with the exception of hearing loss, hematological status, kidney and liver function * active life-threatening infection

Keywords: antibody, neuroblastoma, pediatric, adult
clinical study on the effect of improving sleep quality on cognitive function in patients with epilepsy

Conditions: Epilepsy，Cognition

Summary: epilepsy is one of the common chronic diseases of the central nervous system. 30% to 40% of patients with epilepsy have varying degrees of cognitive impairment, which affects their quality of life. at present, the treatment of cognitive impairment in patients with epilepsy is relatively scarce, and the therapeutic effect is still not ideal. recent studies have shown that sleep disorder is also an important factor causing cognitive dysfunction, and improving sleep quality has a prospect to become a new way to treat cognitive impairment in patients with epilepsy. the purpose of this study is to observe the relationship between sleep and cognitive function in patients with epilepsy, and to improve the sleep quality of patients with epilepsy, so as to provide new ideas for improving cognitive impairment in patients with epilepsy.


Eligibility criteria:
inclusion criteria: * 1. in accordance with the diagnostic criteria of epilepsy; 2. history of epilepsy ≥ 1 year; 3. epilepsy with cognitive impairment; 4. age 7-65 years old; 5. there was no change in the type and dose of antiepileptic drugs during the experiment; 6. patients and their families were aware of this study and signed an informed consent form. exclusion criteria: * 1. status epilepticus; 2. complicated with severe infection, cerebrovascular diseases, malignant tumors, other nervous system diseases, and systemic diseases that can involve the nervous system (such as immune diseases, etc.), serious dysfunction of heart, liver, kidney and other organs; 3. non-epileptic seizures such as syncope and hysteria; 4. women during lactation or pregnancy; 5. combined use of sleeping and sedative drugs; 6. there are contraindications of melatonin and percutaneous vagal nerve stimulation (tvns).
"prevention and treatment of depression in the elderly: a population-based study"

Conditions: Subsyndromic Symptoms of Depression; Subsyndromic Symptoms of Anxiety

Summary: considering the rapid increase of the elderly population in brazil and the growing impact of depression, the third cause of global burden of diseases in the world, the relevance of depression prevention and treatment in older people tend to raise in future years. the investigators planned to screen 2,700 individuals, 60 years and older, from basic health units in the west region of sao paulo city, for subsyndromic depressive and / or anxiety symptoms. the elderly will be assessed with a standardized psychiatric interview to calculate the prevalence of subsyndromic symptoms of depression and / or anxiety and the prevalence of depressive and anxiety disorders. those who do not meet criteria for depressive disorders and / or anxiety will be invited to participate in a randomized clinical trial with 2 arms: a stepped-care prevention program with physical activity (n = 35) or usual care (n = 35). the primary outcome measure will be the cumulative incidence of major depressive disorder, or anxiety disorders, after 12 months.


Eligibility criteria:
inclusion criteria: 60 years or older with subsyndromal symptoms of depression or anxiety, enrolled in one of the selected project west region ubs, who agree with the information presented in the free and informed consent term. a subject is defined as having subsyndromal symptoms of depression and / or anxiety, when he or she scores 13 or more on the ces-d scale, but does not meet criteria for a depressive or anxiety disorder, assessed by applying the "mini international neuropsychiatric interview "(mini) (sheehan et al, 1998;. marques de azevedo and zuardi, 2008). exclusion criteria: those who meet criteria for major depression, dysthymia and / or anxiety disorders, or unable to consent to participate in this research project. all seniors will be interviewed in their homes.

Keywords: subsyndromic symptoms of depression subsyndromic symptoms of anxiety elderly physical activity population-based study