Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of an adjuvanted trivalent influenza vaccine in children 6 to <72 months of age in mexico.

Conditions: Influenza

Summary: the administration of adjuvanted trivalent influenza vaccine (ativ) has come to result in a more immunogenic and effective response compared with conventional influenza vaccines in elderly and adults. the aim of this study is to evaluate safety and immunogenicity of novartis ativ in children 6 to \<72 months of age, mexican population, in comparison to fluzone, a non-adjuvanted trivalent influenza vaccine (tiv).


Eligibility criteria:
inclusion criteria: * individuals of \>6 months through \<72 months of age on the day of informed consent. * individuals whose parent(s)/legal guardian(s) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. * individuals who can comply with study procedures. * willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response. exclusion criteria: * progressive, unstable or uncontrolled clinical conditions. * hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. * history of progressive or severe neurologic disorder, seizure disorder or guillain-barré syndrome. * surgery planned during the study period that in the investigator's opinion would interfere with the study visits schedule. * known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. * any fatal prognosis of an underlying medical condition (\<12 month life expectancy). * clinical conditions representing a contraindication to intramuscular vaccination and blood draws. * abnormal function of the immune system resulting from: 1. clinical conditions. 2. systemic administration of corticosteroids (po/iv/im) for more than 14 consecutive days within 90 days prior to informed consent. 3. administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. * received immunoglobulins or any blood products within 180 days prior to informed consent. * received an investigational or non-registered medicinal product within 30 days prior to informed consent. * study personnel as an immediate family or household member. * any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. * received any influenza vaccine (licensed or investigational) or with laboratory confirmed influenza within 6 months prior enrollment. * received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
yoga exercises applied with two different technological access

Conditions: Work Related Stress; Pain; Fatigue

Summary: yoga, a form of exercise designed to bring balance and health to the physical, mental, emotional and spiritual dimensions of the individual, will benefit many white-collar workers by using popular technological environments to increase overall physical activity and well-being. the aim of this study is to examine the effects of yoga exercises applied with two different technological access in white-collar employees on musculoskeletal pain, fatigue, sleep quality, stress level, quality of life and work efficiency.

considering the importance of the workforce and possible health problems in white-collar workers, it seems rational to implement health promotion practices in accordance with the digital age. there is no study in the literature examining the effectiveness of technology-based yoga on selected health outcomes in white-collar workers. based on this shortcoming, the aim of this study is to examine the effects of yoga exercises applied with two different technological access in white-collar employees on musculoskeletal pain, fatigue, sleep quality, stress level, quality of life and work efficiency.

Eligibility criteria:
inclusion criteria: * • working full-time in the last 1 year in administrative, research-development, high-tech education, mind and brain power-based jobs * speaks and writes turkish * in order to join online sessions, participants should have internet access * all answers of the physical activity preparation survey should be selected as "no" exclusion criteria: * • uncontrolled hypertension and uncontrolled arrhythmia patience * individuals who have undergone percutaneous transluminal coronary angiography or have a cardiac pacemaker * individuals with severe neurological disease or serious respiratory disease * previous stroke, myocardial infarction * individuals who have undergone amputation * individuals with major musculoskeletal problems * individuals with injuries involving the lower extremity in the past 6 months * pregnant or planning a pregnancy within 1 year * breastfeeding * use of sleeping pills or medication for psychological problems and/or shift workers

Keywords: white collar workers yoga remote exercise
the impact of covid-19 on the health care utilization of inflammatory bowel disease

Conditions: COVID-19; Perception, Self; Facilities and Services Utilization

Summary: the rapid spread of covid-19 is expected to have a significant impact on medicine as well as all sectors worldwide. in particular, inflammatory bowel disease (ibd) is a chronic immune disease in which remission and activation are repeated and must be treated consistently throughout life. in addition, patients with ibd may be vulnerable to various infectious diseases due to the immuno-compromised state due to the use of immuno-suppressants or biological agents. during a pandemic, patients with ibd may postpone hospital visits due to concerns about infection with covid-19, and if they cannot continue drug treatment, there is a concern about the flare up ibd disease activity. therefore, in this study, we would like to investigate the current status of hospital utilization of ibd patients in daegu, the epidemic area of covid-19, and to investigate the effect of patient perception of covid-19 on hospital ultilization.

background: in the epidemic area of covid-19, emergency treatment of chronic diseases other than covid-19 can be limited. therefore, it is important to reduce the risk of exposure to covid-19 in patients with chronic immune diseases such as ibd, but it is most important to manage well so that the underlying diseases are not exacerbated at times when emergency medical treatment may be difficult. however, there is a lack of evidence on the management policy of chronic immune diseases in the current epidemic, and only expert opinions are being presented. aim: to investigate the current status of hospital utilization of ibd patients in daegu, the epidemic area of covid-19, and to investigate the effect of patient perception of covid-19 on hospital utilization. material and method: this study is a multicenter, prospective, cross-sectional survey which will be consulted in keimyung university dongsan medical center and yeungnam university hospital. patients with ibd aged above 18 will enrolled and surveyed about their perception about covid-19 and status of hospital utilization during pandemic period. patients' demographics and disease-related variables will be evaluated to identify clinical significances.

Eligibility criteria:
inclusion criteria: * patients with inflammatory growth disease, those who agreed to participate in this study exclusion criteria: * those who are unable to understand or answer the questionnaire * those who declined to participate in this study
mixed reality technology in laparoscopic partial nephrectomy

Conditions: Kidney Tumor

Summary: the aim of our study was: a) to evaluate the usefulness of the mr model for renal pedicle exposure and identification of the tumor's exact location during lpn, and b) to evaluate the subjective utility of the mr model as an intraoperative reference tool. investigators prospectively enrolled 47 patients with lpn between june 2020 and february 2021. patients were randomly assigned into two groups: the control group (24 patients), who underwent operation with an intraoperative ultrasound (us) control and the experimental group (23 patients), who underwent operation with the aid of the mr model. randomization was performed using a computerized randomization program and sealed envelopes. patients were included in the study if they were 18 years of age or older, were able to sign informed consent, and had t1a renal tumors amenable to lpn. patients were excluded if they were unwilling to participate or did not meet the inclusion criteria. for each patient, investigators prospectively collected demographic data including age, body mass index, clinical tumor size, side, location, and complexity score according to the padua scoring system; perioperative data (including time for renal pedicle exposure and time for renal tumor detection and duration of ischemia); pathological data; data on postoperative functional outcome and complications, classified according to the clavien-dindo system.


Eligibility criteria:
inclusion criteria: * able to sign informed consent * had t1a renal tumors amenable to lpn exclusion criteria: * were unwilling to participate * did not meet the inclusion criteria
single arm study of bsi-201 in patients with brca-1 or brca-2 associated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer

Conditions: Primary Peritoneal Cancer; Advanced Epithelial Ovarian Cancer

Summary: the goal of this study was to determine the efficacy of iniparib (bsi-201/sar240550) in patients with breast cancer gene-associated (brca) ovarian cancer. up to 35 patients were to be treated using a simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by response evaluation criteria in solid tumor (recist), 23 additional patients were be treated in the second stage.

participants were treated for at least one 8-week cycle, with additional cycles as long as they had stable or responding disease (per recist criteria) and wished to remain on study. participants had a final follow-up visit within 4 weeks following the last dose of iniparib, after which time they were contacted by study staff every 3 months for the first year and every 6 months thereafter to assess disease status and survival.

Eligibility criteria:
inclusion criteria: * female, age 18 or older; * histologically or cytologically confirmed advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (stage iii or iv); * at least one previous regimen with platinum/taxane combination therapy and no curative options as determined by their physician (no limit on the number of prior therapies); * confirmed brca1 or brca2 status; * one or more measurable lesions, at least 10mm in longest diameter by spiral computed tomography (ct) scan or 20mm in longest diameter when measured with conventional techniques (palpation, plain x-ray, ct or magnetic resonance imaging (mri)); * karnofsky performance status ≥70%; * estimated life expectancy of at least 16 weeks. exclusion criteria: * normal clinical laboratory values; * any anti-cancer therapy within 21 days prior to study start; * any other malignancy within 3 years of study start, except adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (dcis) of the breast, or basal or squamous cell skin cancer; * active viral infection including hiv/aids, hepatitis b or hepatitis c infection; * active central nervous system or brain metastases; * history of seizures or current treatment with anti-epileptic medication; * persistent grade 2 or greater toxicities from prior therapy, excluding alopecia.

Keywords: brca-1 or brca-2 associated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer brca-1 brca-2
a scalable model for promoting functioning and well-being among older adults with mild cognitive impairment via meaningful social interactions: project speak!

Conditions: Mild Cognitive Impairment

Summary: the goal of this study is to refine and test a strategy for engaging older adults with symptoms of scd/mci (subjective cognitive decline/mild cognitive impairment) as volunteers to help english language learners (ells) who live in the us improve their speaking skills via structured conversations using videoconferencing.

aim 1: conduct a user-centered design process to refine the speak! training protocols for older adults with symptoms of scd/mci and ells, and the materials that will support productive engaging english conversation practice. aim 2: conduct a randomized, wait-list controlled trial of 8 weeks of speak! participation, using a variety of recruitment sources, in order to evaluate our capacity to recruit, implement the intervention, and retain older adults with symptoms of scd/mci in sufficient numbers for a subsequent randomized-controlled trial evaluating the intervention's impact on participants' psychological well-being, mood, and cognitive functioning. aim 3: using mixed methods, evaluate the communication process between older adults with symptoms of scd/mci and ells including factors that contribute to satisfaction of both parties, engagement in planned contacts, possible contributors to stress or dissatisfaction, and perceptions among older adults of being appreciated and effective. the investigators will also estimate variances for key outcome variables and conduct exploratory analyses of intervention-control differences in participants' perceptions of their wellbeing, mood, and cognitive functioning.

Eligibility criteria:
mild cognitive impairment participant -- inclusion criteria: * 55+ years of age, fluent speakers of english of any race/ethnicity, and be able to participate in a videoconference via a smartphone, tablet laptop, or desktop computer in their home or referring organization using a widely accessible, no cost videoconferencing platform. exclusion criteria: * participants will be ineligible if they have a history of stroke or traumatic brain injury, bipolar disorder, schizophrenia, or current alcohol or drug abuse/dependence, that would affect their ability to participate in the study; moca score \<12.
dual source ct angiography for detection of coronary artery stenoses

Conditions: Coronary Artery Disease

Summary: the trial will investigate the accuracy of dual source ct coronary angiography to detect coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an intermediate likelihood for the presence of coronary artery stenoses. no beta blockers will be used to lower the heart rate for the examination. the hypothesis is that dual source ct will allow the detection of vessels with at least one coronary artery stenosis with a sensitivity of more than 90%.


Eligibility criteria:
inclusion criteria: * suspected coronary artery disease * chest pain * intermediate likelihood of coronary stenoses * planned invasive coronary angiography * age 30 to 80 years exclusion criteria: * non sinus rhythm * contrast allergy * renal failure * unstable clinical condition * previous coronary revascularization * calcium score exceeding 800 * inability to perform 10 second breathhold * possible pregnancy * metformin medication that cannot be interrupted * inability to establish antecubital iv access

Keywords: coronary artery disease chest pain computed tomography
speech intelligibility of patients with p d compared to first degree relatives of p d patients

Conditions: Parkinson's Disease

Summary: this study will examine speech intelligibility of early parkinson's disease (pd) patients, early pd patients and first degree relatives. the investigators hypothesis that advanced pd patients will present decreased speech intelligibility more than early pd patients. speech intelligibility of first degree relatives will be normal.

in order to achieve the study's goals objective and subjective research tools will be used. objective tools include measuring phonation time, diadokokinetic movements of the oral structures and acoustic analysis . subjective tools include self reported questionnaires.

Eligibility criteria:
inclusion criteria:a * advanced pd patients * early pd patients * first degree relatives exclusion criteria: * patients with decreased cognitive abilities * patients who participate in speech therapy
insulin sensitivity and secretion during pregnancy and post partum in women with gestational diabetes.

Conditions: Diabetes, Gestational

Summary: aim of the study: to define insulin requirement during pregnancy and to identify the rapid changes in insulin sensitivity around parturition and the first 6 months post partum. such knowledge would be clinically useful and markedly improve insulin treatment before and after parturition for women with type 1 diabetes and serve to identify the best possible timing of testing women with gestational diabetes mellitus (gdm) for the development of type 2 diabetes post partum. method: botnia clamp in women before, immediately after delivery and 6 months post partum. the investigators will compare 20 women with gdm in late pregnancy, day 15 post partum and 6 months post partum with 20 normal women investigated at the same time points. in addition the investigators will collect feces samples from the mother and baby in order to determine microbiota. perspectives: diabetes is a common condition with important implications for pregnancy outcome and long-term morbidity for mother and offspring. accordingly, tailoring the best treatment is expected to have beneficial consequences both for the pregnant women and the future generation.


Eligibility criteria:
inclusion criteria: * written consent before study start. * pregnant. * gdm for the gdm group. * no diabetes for the control group. exclusion criteria: * women with multiple pregnancy. * new pregnancy before all three examinations has been done. * severe, debilitating, concurrent diseases. * serious or intolerable adverse reactions associated with the studies.

Keywords: insulin sensitivity
towards an algorithmic approach to asthma management: collaborative definition of algorithm objectives with families

Conditions: Childhood Asthma

Summary: using "big data" and artificial intelligence techniques, it becomes possible to envision algorithms for managing childhood asthma on a daily basis. in order to develop such tools, it is necessary to determine with asthma stakeholders (children, parents, doctors) the parameters that future algorithms should seek to maximize / minimize. the main objective of the study is to quantify the respective importance of each of the goals that children with asthma, parents, and their doctors seek to achieve when taking / supervising / prescribing a background therapy.

using "big data" and artificial intelligence techniques, it becomes possible to envision algorithms for managing childhood asthma on a daily basis. in order to develop such tools, it is necessary to determine with asthma stakeholders (children, parents, doctors) the parameters that future algorithms should seek to maximize / minimize. the main objective of the study is to quantify the respective importance of each of the goals that children with asthma, parents, and their doctors seek to achieve when taking / supervising / prescribing a background therapy. to do this, parents and children fill out a paper questionnaire, which is completed by their doctor, when they come to the hospital for consultation, hospitalization, or to perform lung function tests. concerning children and parents, these questionnaires include a part aimed at prioritizing each person's objectives and a second part collecting general information regarding their characteristics (age, sex, asthma history, etc.).

Eligibility criteria:
inclusion criteria: * minor patients aged 8 years to 17 years and 11 months inclusive with a diagnosis of asthma made by a doctor and a basic treatment for asthma * holders of parental authority for patients meeting the above criteria * doctors caring for children with asthma * information and non-opposition of holders of parental authority and minor patients to participate in the study exclusion criteria: * refusal to participate in the study * difficulties in french writing and / or speaking

Keywords: childhood asthma algorithms for managing childhood asthma big data artificial intelligence
sensory processing associated with motor skills

Conditions: Preterm Birth; Sensory Processing Disorder; Motor Delay

Summary: in the study, sensory processing skills of 1-year-old preterm and term children will be evaluated. the relationship between sensory processing skills and gross and fine motor development will be investigated.


Eligibility criteria:
inclusion criteria: premature group: healthy children with a gestational age below 34 weeks term group: healthy children with gestational age between 37-41 weeks exclusion criteria: they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.
identifying right ventricular dysfunction in copd through right heart catheterization, imaging and exercise

Conditions: COPD; Pulmonary Hypertension; Right Ventricular Dysfunction

Summary: this study plans to learn more about heart function among individuals with chronic obstructive pulmonary disease (copd). in particular, the investigators want to understand the different patterns of right ventricular response to pulmonary hypertension (high pressure in the lungs) during rest and exercise. by identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with copd in the future.


Eligibility criteria:
inclusion criteria: * copd (determined by ratio of forced expiratory volume in 1 second to forced vital capacity \[fev1/fvc\] \ 1 or \>30 mm on most recent ct exclusion criteria: * exacerbation of copd or use of systemic corticosteroids in the 3 months prior to enrollment * change in copd therapy in the 3 weeks prior to enrollment * requirement of \>6 lpm supplemental oxygen at rest * requirement of \>10 lpm with exertion * active/uncontrolled cardiovascular disease (e.g. hypertension with blood pressure \>150/100 despite antihypertensives; coronary artery disease with angina; left ventricular ejection fraction ≤40%; arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than mildin severity; tricuspid regurgitation greater than moderate in severity; diabetes with hba1c \>8.5%) * volume overload (jugular vascular distension or greater than trace peripheral edema) * interstitial lung disease * untreated severe obstructive sleep apnea * active malignancy * medical conditions that limit exercise on an upright stationary bicycle (e.g. osteoarthritis, etc.) * pregnancy * body mass index \ 35 * hematocrit \ 55% * for optional part 2 i.e. exercise training and visit 2, residence \>90 miles from university of colorado anschutz medical campus or unwillingness/inability to attend exercise training sessions for approximately 35 minutes 3x/week for 12 weeks * for optional part 2 i.e. exercise training and visit 2, already engaged in routine exercise training (\>30 minutes at \>3 mets 3 times/week or more)
a study to prevent rebleeding after initial successful primary endoscopic haemostasis of a bleeding peptic ulcer

Conditions: Gastrointestinal Hemorrhage

Summary: this study is being carried out to see if constant 3 days infusion of nexium is effective in preventing rebleeding after an endoscopic treatment.


Eligibility criteria:
inclusion criteria: * signs of a bleeding in the stomach * one endoscopically confirmed bleeding ulcer in the stomach or duodenum exclusion criteria: * malignancy or other advanced disease. * major cardiovascular event. * severe hepatic disease