Kornimate/medical-research-clean huggingface dataset:
parenteral nutrition in patients with biliopancreatic mass lesions

Conditions: Weight Loss; Pancreatic Cancer; Biliary Tract Cancer

Summary: patients with biliopancreatic tumors are at risk for malnutrition and have to undergo many procedures for diagnostic workup that require fasting periods. in a prospective randomized monocentric study we evaluate the effect of additional parenteral nutrition on weight loss, nutritional status, quality of life and length of hospital stay.

patients with pancreatic and biliary tract cancer suffer from weight loss, malnutrition and cachexia. these factors are associated with poor prognosis, reduction in quality of life and a higher risk of complications during treatment. moreover, patients undergo fasting periods during their diagnostic work-up at hospital that worsens malnutrition. this is a prospective randomized monocentric study to investigate, whether parenteral nutritional supplementation may have an impact on weight loss, nutritional status, quality of life and length of hospital stay in patients with tumors of the pancreas or biliary tract. patients either receive 1 l olimel peri 2.5 %® (baxter germany gmbh medication delivery, unterschleißheim, germany containing 700 kcal, 25.3 g protein, 30.0 g fat and 75.0 g glucose) on fasting days or 1 l of isotonic fluid (e153, berlin-chemie ag, berlin, germany) in the control group. a hospital stay of at least three days is required. patients are assessed for anthropometric measurements, bioelectrical impedance analysis, quality of life and length of hospital stay.

Eligibility criteria:
inclusion criteria: * hospitalization for suspected biliopancreatic mass lesion * consent to participate to the study exclusion criteria: * liver cirrhosis (child-pugh b and c) * heart or renal failure (grade iii or more) * dementia * pregnancy * hospital stay less than 3 days

Keywords: malnutrition parenteral nutrition weight loss pancreatic cancer biliary tract cancer quality of life
improving 24-hour blood pressure stability in spinal cord injury with low oxygen therapy

Conditions: Spinal Cord Injury

Summary: this study examines the effects of low oxygen therapy (lot) on the stability of 24-hour blood pressure in persons with chronic cervical spinal cord injury. this study will examine if brief episodes of breathing lower oxygen, termed low oxygen therapy (lot), which has been shown to enhance autonomic nervous system activity, can improve blood pressure stability in individuals with spinal cord injury. the research team will assess 24-hour blood pressure, as well as cardiac, vascular, and autonomic function before and after a 4-day lot treatment intervention. this study will advance current understanding of treatments to mitigate cardiovascular disease risk in people with spinal cord injuries.

spinal cord injury (sci) interrupts signals travelling down from the brain to the rest of the body below the level of the injury. the loss of nerve connections involved in cardiovascular control results in blood pressure instability. this can lead to sudden drops in blood pressure, such as when shifting upright or during transfers, or sudden increases during autonomic dysreflexia. these swings in blood pressure are linked to a nearly 4-fold increase in the risk of cardiovascular disease in people with sci. repeated, brief exposure to breathing lower levels of oxygen, termed low oxygen therapy, has been shown to stimulate adaptation in the nervous system. this neuroplasticity increases the activity of cardiovascular control circuits, and has been shown to increase blood pressure in able-bodied individuals. similar effects on respiratory and motor function in people with sci, but the effects on the cardiovascular system have not been studied in this population. this study will test the effects of a 4-day low oxygen therapy intervention on 24-hour blood pressure stability in people with chronic cervical sci. by assessing mechanisms of cardiac, vascular, and autonomic function, this study aims to improve current understanding of the therapeutic potential of low oxygen therapy to mitigate cardiovascular disease risk in sci.

Eligibility criteria:
inclusion criteria: * are between the ages of 19-65 * living with a chronic cervical (at or above t1) spinal cord injury of at least one year * are fluent in english exclusion criteria: * high-cervical injuries requiring ventilator assistance to breathe will be excluded on account of the necessity of the facemask for the delivery of hypoxia * unhealed fracture, contracture, or pressure sore that might interfere with participants' ability to complete the protocol * additional concurrent neurological conditions (e.g., multiple sclerosis, parkinson disease, stroke or brain injury) * uncontrolled cardiovascular or pulmonary disease * severe neuropathic pain * severe recurrent autonomic dysreflexia * history of seizure disorders * known pregnancy

Keywords: low oxygen therapy intermittent hypoxia blood pressure spinal cord injury cardiac function sympathetic nervous system
maternal use of antibiotics and the risk of congenital malformations

Conditions: Congenital Malformations

Summary: antibiotics are widely used during pregnancy to prevent or treat infections, yet concerns remain regarding their fetal safety. drawing on data from spontaneous reporting databases and cohort studies, this study aims to explore potential associations between exposure to various antibiotic classes during pregnancy and congenital malformations. data were collected from publicly available reports in the u.s. food and drug administration's adverse event reporting system (faers), the canada vigilance adverse reaction (cvar) database, and a population-based retrospective cohort in xiamen, china. by applying multiple signal detection methods, we identified potential risk signals linking different antibiotic classes to organ-system-specific congenital malformations. for antibiotics showing positive signals, we further utilized a pregnancy medication cohort in xiamen and applied causal inference techniques to estimate the adjusted relative risk of congenital malformations associated with first-trimester exposure to these antibiotics. several sensitivity analyses-including both negative- and positive-control analyses-will also be performed.


Eligibility criteria:
inclusion criteria: * for the spontaneous reporting data study, all adverse reactions reported by mothers were included. for the cohort study, all xiamen pregnant women registered in the cohort were included exclusion criteria: * for studies using spontaneous reporting data, all adverse reaction reports unrelated to pregnant or postpartum women-including those occurring during the lactation period-were excluded. for cohort studies, pregnant women who were lost to follow-up were excluded, and pregnant women who were exposed to factors known to be associated with congenital malformations were excluded.

Keywords: antibiotic; congenital malformation; pregnancy; spontaneous report; cohort
mobile app utilization for enhanced post-operative nutritional recovery

Conditions: GI Cancer; Nutritional Deficiency

Summary: this study is to assess the usability and acceptability of a digital food consumption diary as part of the perioperative management of gastrointestinal oncology patients and to evaluate the impact of a digital food diary on adherence to dietician-recommended plan and on quality recovery, using a commercially available smart phone application.


Eligibility criteria:
inclusion criteria: * diagnosis of gastrointestinal (gi) cancers confirmed by tissue diagnosis and/or clinical presentation as judged by the treating physician * candidate for curative-intent surgery * participants will be eligible for participation regardless of degree of malnutrition (as determined at pre-operative dietary consultation) * own a smartphone with ios or android operating systems with wifi or 3g/4g connection * willingness to download the livestrong.com myplate calorie tracker onto a personal smart phone with assumption and responsibility for individual data usage, and creation of login for website data extraction * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study. * sufficient english language proficiency to execute study tasks exclusion criteria: * participants with tube feeds and/or need for parenteral/enteral nutrition * participants not willing to download or utilize the commercially available weight monitoring application

Keywords: food diary malnutrition
brain training in children with/at-risk for attention-deficit/hyperactivity disorder and executive function impairment

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to determine if different forms of child-friendly, computer-based puzzles and games ("brain training") targeting executive function (ef) skills (i.e., thinking, problem-solving) result in improvements in ef in preschool children with or at-risk for attention-deficit/hyperactivity disorder (adhd) and ef problems. the investigators hypothesize that children receiving active "brain training" will show greater improvements in ef and related skills immediately after treatment than children receiving passive "brain training." the investigators are also interested in whether any improvements in ef and related skills occur or are maintained at 3 and 6 months after completion of brain training.

* investigators will talk to you by telephone to determine if your child might be eligible for the study. * children complete two baseline testing sessions to evaluate executive function (ef) and related skills * parents complete a packet of information, including questionnaires about the child's behavior, ef, and functional skills. * after completion of the baseline testing, we will inform you of eligibility for the "brain training" phase. * during "brain training" children play online computer games for 25-30 minutes/day (can range from 15-45 minutes/day depending on your child's attention, training version received, number and length of breaks needed), 5 days a week, for 5-7 weeks to complete a total of 25 sessions. * children return for 3 more time points, immediately after the completion of "brain training" (1 session), and also at 3 months (1 session) and 6 months (2 sessions) after completion of "brain training."

Eligibility criteria:
inclusion criteria: * age 4 or 5 years * born full term (37 weeks gestation or greater) * diagnosis of adhd or high adhd symptoms (t-score 60 or greater on standardized behavior questionnaire) * able to comprehend task instructions exclusion criteria: * major neurosensory impairment (ie blind, deaf) that interferes with testing * genetic syndrome * inability to comprehend task instructions

Keywords: attention deficit hyperactivity disorder; executive function; preschool
serology to covid-19 for recording exposures and evaluating needs

Conditions: Covid19; Coronavirus; SARS-CoV Infection

Summary: as the global and pandemic spread of the novel coronavirus (sars-cov-2, covid-19) continues, many knowledge gaps remain with regard to the epidemiology and transmission of infection, as well as the normal immunological responses after viral exposure. cincinnati had its first confirmed case of covid-19 on march 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread continues at over 150-200 new cases per week. as new residents and fellows arrive in july 2020 to cincinnati children's hospital medical center (cchmc), many of whom come from metropolitan areas across the country, it is imperative that investigators determine the current prevalence of infection, measure the cumulative incidence of infection over the next 12-24 months, investigate the normal antibody patterns after infection, and help elucidate what constitutes a protective immunological response. the investigators have a unique but time-limited opportunity to optimally track the epidemiology and natural history of sars-cov-2 infection among trainees at cchmc, including risk factors for transmission and immunological recovery. screen will investigate epidemiological and immunological features of sars-cov-2 virus infection within the cohort of cchmc residents and fellows who have patient contact. by collecting and analyzing weekly serial samples for sars-cov-2 (nasal swab for virus by pcr) and monthly serological exposure (serum antibodies by elisa), the investigators will determine the prevalence and cumulative incidence of infection by sars-cov-2; the investigators will also document the antibody responses over time and identify cases of apparent viral recrudescence or re-infection.


Eligibility criteria:
inclusion criteria: * current full-time residents and fellows at cchmc * cell phone that can be used for text messaging or web-based viewing of surveys * willing and able to provide informed consent * ability to comply with all study related evaluations and follow-up exclusion criteria: * any condition or illness that makes study participation ill-advised
safety and efficacy of relestat ophthalmic solution 0.05% for allergic conjunctivitis in korea

Conditions: Conjunctivitis, Allergic

Summary: this study is a post-marketing surveillance study in korea to evaluate the safety and efficacy of relestat ophthalmic solution 0.05% in patients with allergic conjunctivitis who are treated with relestat as standard of care in clinical practice.


Eligibility criteria:
inclusion criteria: * patients with allergic conjunctivitis treated with relestat ophthalmic solution in clinical practice. exclusion criteria: * none.
evaluation of electrical velocimetry for assessment of extra-vascular lung water in pre-eclamptic patients

Conditions: Pre-Eclampsia

Summary: the purpose of this study is to compare the sensitivity and the specificity of electrical cardiometry to the lung ultrasound in measuring thoracic lung water in pregnant females with pre-eclampsia. if electrical cardiometry is validated against ultrasound, it will be easy to use with numerical number that will not require advanced experience as with the ultrasound.

pre-eclampsia is accompanied with increased risk of serious complications such as pulmonary edema, cerebrovascular accidents, coagulopathy, and hemorrhage. pre-eclampsia is responsible for 46.6% of the etiology of acute pulmonary edema in pregnant women. fluid management in pre-eclamptic patients is challenging. hypovolemia exacerbates organ failure, whereas volume overload results in pulmonary edema. thus, using different methods for evaluation of volume status of the patients would improve patient management. lung ultrasound has been developed as an accurate non-invasive method for assessment of extra-vascular lung water; however, ultrasound needs skilled operator. electrical velocimetry (cardiometry) is a newer technology for assessment of total thoracic fluid content (tfc); however, it has not been validated in pre-eclamptic patients. in this study the investigators will validate the accuracy of cardiometry in evaluation of lung water using the lung ultrasound as a gold standard. both methods will be evaluated for prediction of the need of diuretic therapy and the need for post-operative oxygen therapy.

Eligibility criteria:
inclusion criteria: * pregnant * pre-eclamptic * in first stage of labor exclusion criteria: * eclampsia. * second, third and fourth stages of labor on admission. * patients with severe cardiac and/or pulmonary disease.
progressive myopia treatment evaluation for naturalvue multifocal contact lens trial

Conditions: Myopia

Summary: this is a multi-center, randomized, double-masked clinical trial. all study devices are market approved/cleared in the localities where the study is conducted. subjects will be randomly assigned to wear naturalvue sphere single vision contact lenses (svcl) or naturalvue multifocal (nvmf) soft contact lenses for a total of three years.


Eligibility criteria:
inclusion criteria: 1. male or female, aged 7 to \<13 (inclusive) at the screening/baseline examination. 2. meet the following refractive criteria determined by cycloplegic autorefraction at screening/baseline: * spherical equivalent refractive error (sere): between -0.75 and -5.00 d inclusive. * astigmatism: ≤ -0.75 d * anisometropia: \< 1.000 exclusion criteria: 1. has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses, 2. appears to exhibit poor personal hygiene, that, in the investigator's opinion, might prevent safe contact lens wear. 3. is currently, or within 30 days prior to this study has been, an active participant in another clinical study. 4. current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, multifocal or specialized contact lenses, or any other myopia control treatment. 5. the investigator for any reason considers that it is not in the best interest of the subject to participate in the study, including if the child is not mature enough to independently handle and care for soft contact lenses.

Keywords: myopia refractive error
preclinical brain tumor models

Conditions: Brain Metastases; Diffuse Gliomas

Summary: background: primary or secondary brain tumors (metastases) remain associated with a very poor prognosis linked to significant therapeutic resistance. thus, glioblastoma, which is the most common and aggressive primary brain tumor in adults, is associated with inevitable relapses within 7 to 10 months and median survival of approximately 12 to 14 months. at the same time, brain metastases are increasingly increasing following better systemic control of other metastatic sites and improvement in detection methods. however, they remain resistant to the latest therapeutic innovations such as immunotherapies or targeted therapies. in this context, innovative strategies are necessary to identify new therapeutic targets and implement new treatments to overcome resistance phenomena in the clinic. objective: our goal will be to generate tumoroids and stem-like cell lines (pdx) from patient tumor samples. methods: we will establish tumor tumoroids and stem cell lines from patient samples. these preclinical models will allow us to test a large number of drugs, quickly and efficiently thanks to models as close as possible to patient tumors and limiting the use of animal models (3r). overall, this project should enable major advances in the treatment of glioblastoma and brain metastases and enable the rapid testing of new molecules in clinical trials thanks to the homology of our models with our patients' diseases.


Eligibility criteria:
inclusion criteria: * adult patients * brain tumor neuro-imaging * eligible for neurosurgery exclusion criteria: * unresectable tumor

Keywords: brain metastases glioma glioblastoma preclinical models tumoroids cell lines
a 2-week clinical comparison of systane® ultra to sensitive eyes rewetting drops in contact lens wearing patients.

Conditions: Dry Eye

Summary: to evaluate safety with the use of systane ultra in contact lens wearers. a comparison to a currently marketed contact lens rewetting drop will be included as a control.


Eligibility criteria:
inclusion criteria: * participants must be between 18 and 65 years of age. * provide written informed consent. * must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality, or a rigid gas permeable (rgp) contact lens * must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye. * sodium fluorescein (nafl) corneal staining score sum of \< 2 in both eyes (nei scoring system). * must be willing to maintain pre-enrollment systemic medication regimens during the study. * must be available for study visits and to fill out study questionnaires. exclusion criteria: * has modified their systemic medications within 30 days prior to enrollment. * has a history of allergy to any study product ingredients * is unwilling or unable to meet the study visit timeline. * has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the investigator, would adversely affect successful contact lens wear. * is currently using any topical eye medications (not including rewetting drops, artificial tear products or restasis).

Keywords: dry eye re-wetting drops
a study to assess the burden of herpes zoster and postherpetic neuralgia in japanese adults aged sixty years and above

Conditions: Herpes Zoster

Summary: the study aims to estimate the incidence of herpes zoster (hz), proportion of postherpetic neuralgia (phn) and the economic burden and impact on quality of life, in japanese adults greater than or equal to sixty years of age.


Eligibility criteria:
inclusion criteria: * subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * written informed consent obtained from the subject. * a male or female greater than or equal to sixty years of age, presenting with hz at the time of enrollment. * hz diagnosis. * is the subject's first outpatient diagnosis for this hz episode. or * took place up to seven days prior to the initial visit for the present study. note: recurrent hz cases may be enrolled as new cases based on the investigator's clinical practice. exclusion criteria: • not applicable.

Keywords: quality of life herpes zoster postherpetic neuralgia japan physician-practice adults health economics
an expanded access program for risdiplam in participants with spinal muscular atrophy (sma)

Conditions: Muscular Atrophy, Spinal

Summary: this expanded access program (eap) will provide access to risdiplam for eligible participants with type 1 or type 2 spinal muscular atrophy (sma) before it is commercially available in the united states for the indication of sma.


Eligibility criteria:
inclusion criteria: all participants: * not eligible for treatment with currently approved treatments for sma, or cannot continue treatment with currently approved medications as documented by the treating physician, or in the treating physician's judgment, the participant is at risk of lack/loss of treatment efficacy of the current therapy. * the participant does not qualify for and has no access to sma treatment in the context of an ongoing clinical trial. * adequately recovered from any acute illness at the time of screening, and considered clinically well enough to participate, in the opinion of the treating physician. * participants with retinopathy of prematurity should have evidence of stable disease. type 1 sma participants: - confirmed diagnosis of 5q-autosomal recessive sma. type 2 sma participants: * confirmed diagnosis of 5q-autosomal recessive sma. * negative blood pregnancy test at screening (all women of childbearing potential, including those who have had a tubal ligation), and agreement to comply with measures to prevent pregnancy and restrictions on egg and sperm donation. * males with female partners of reproductive potential must agree to use highly effective contraception during therapy, and for at least 4 months after treatment discontinuation. exclusion criteria: * inability to meet program requirements. * concomitant or previous participation in any investigational drug or device study within 90 days prior to screening or 5 half-lives, whichever is longer. * administration of other smn-2 targeting therapy within 120 days of starting risdiplam therapy. * administration of sma gene therapy within the last 3 months (12 weeks) of receiving risdiplam therapy. * any serious medical condition, treatment, or abnormality in clinical laboratory tests that, in the treating physician's judgment, precludes the participant's safe participation in the program. * ascertained or presumptive hypersensitivity (e.g., anaphylactic reaction) to risdiplam or to the constituents of its formulation. * suspicion of illicit drug or alcohol abuse, in the treating physician's judgment. * any prior use of an inhibitor or inducer of flavin-containing monooxygenases 1 (fmo1) or flavin-containing monooxygenases 3 (fmo3) taken within 2 weeks (or within 5 times the elimination half-life, whichever is longer) prior to dosing.