Kornimate/medical-research-clean huggingface dataset:
study of total energy expenditure in infants and children with moderate to severe cystic fibrosis

Conditions: Cystic Fibrosis

Summary: objectives: i. compare the resting energy expenditure using respiratory calorimetry in infants and children with moderate to severe cystic fibrosis versus age matched healthy controls. ii. determine the total energy expenditure and energy spent on physical activity using the doubly labeled water method in these patient populations.

protocol outline: patients and healthy controls receive an oral dose of doubly labeled water following initial urine collection on day 1. patients undergo additional urine collection at 4-6 hours following doubly labeled water consumption and then daily for 7 days. additionally, at the beginning of the study, patients and healthy controls undergo respiratory calorimetry over approximately 45 minutes at rest, starting approximately 2-3 hours after the last meal consumption and last use of aerosol bronchodilators (if required).

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of cystic fibrosis (cf) by two positive sweat tests no exacerbations of present condition within past 2 months fev1 less than 50% of predicted no other uncorrected lung disease no requirement for supplemental oxygen or * healthy (control group) age matched to cf patients no preexisting lung disease clinically well no hospitalizations within past 6 months --prior/concurrent therapy-- * concurrent pancreatic enzyme supplementation for cf required clinically stable on current medications (cf patients) --patient characteristics-- * age: birth to 12 months 6 to 10 years * cardiovascular: no major cardiovascular problems (cf patients) no preexisting heart disease (control group) * pulmonary: see disease characteristics * other: no chromosomal abnormalities (cf patients) no acute infection (cf patients) no diabetes mellitus (both groups)

Keywords: cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease
califormula study: calibrated formula feeding to optimize infant growth

Conditions: Overweight and Obesity

Summary: the purpose of this voluntary research study is to determine if calibrated formula feeding recommendations can promote optimal growth for the first 6 months after birth for mothers with a pre-pregnancy body mass index of 25 or more.

this pilot study seeks to determine if formula feeding recommendations that are calibrated using age and weight specific caloric intake recommendations can prevent excessive infant weight gain and reduce overweight in the first 6 months after birth among infants born to mothers with overweight prior to pregnancy electing to exclusively formula feed their infants. calibrated formula feeding refers to adjusting the recommended daily caloric formula intake to account for weight status. a cohort of 60 infants will be recruited and randomized 2-3 weeks after birth to an intervention arm characterized by calibrated formula feeding recommendations or a control group with ad lib feeds as per usual care. intervention group parents will also be given written instructions on infant hunger and satiety cues as well as copies of videos with guidance on bottle feeding and how to soothe fussy infants without feeding. the investigators hypothesize that the calibrated formula intake intervention will reduce rapid infant gain and overweight during infancy resulting in lower weight-for-length at age 6 months.

Eligibility criteria:
inclusion criteria: * term or early term (≥37 weeks), singleton infants * infant birthweight ≥50th percentile based on the 2013 fenton growth charts (which account for sex of child and gestational age at birth) * infant without substantial neonatal morbidity that would affect feeding or weight gain (e.g. known chromosomal abnormality, metabolic disorder, cleft lip/palate, etc.) * infant age ≤1 month * mothers with pre-pregnancy body mass index ≥25 kg/m2 * mothers ≥18 years old * parental plan to exclusively feed infant 19-20 kcal/ounce formula upon delivery or by the start of the intervention period \~1 month after delivery * parental intention to have infant well child visits through age 6 months at a division of academic general pediatrics practice site (hope drive, elizabethtown, nyes road) * english speaking parent exclusion criteria: * infants who weigh less than their birthweight 21 days after delivery
the diagnosis of npc using the probe-based confocal laser endomicroscopy

Conditions: Nasopharyngeal Carcinoma; Squamous Cell Carcinoma of the Head and Neck

Summary: to evaluate the use of probe-based confocal laser endomicroscopy (pcle) in human nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas.

the aim of this study was to depict the applicability of pcle examinations for diagnosing npc in comparison to the gold standard of histopathological examination, as well as developed an easy-to-use and straightforward scoring system for the identification of npc on the basis of morphological and architectural criteria in order to enable a valid and reproducible cle assessment even for non-experts in their daily clinical practice.

Eligibility criteria:
inclusion criteria: 1. male or female \> 18 years of age 2. indicated for nasal endoscope for indeterminate npc 3. willing and able to comply with study procedures and provide written informed consent to participate in the study exclusion criteria: 1. subjects for whom pcle procedures are contraindicated 2. known allergy to fluorescein dye 3. if female, pregnant based on a positive hcg serum or an in vitro diagnostic test result or breast-feeding

Keywords: probe-based confocal laser endomicroscopy optical biopsy
study of lanreotide in non metastatic castration-resistant prostate cancer patients

Conditions: Prostate Cancer

Summary: the aim of the study is to compare in an exploratory fashion the efficacy on progression-free survival of lanreotide in addition to non steroidal anti androgens and lhrh-a in non metastatic castrate resistant prostate cancer patients.

lhrh-a=luteinizing hormone-releasing hormone analogues

Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of prostate cancer * evidence of psa progression despite castrate levels of testosterone (\<50 ng/dl) following orchiectomy or during therapy with luteinizing hormone releasing hormone agonists (lhrh-a) * patients with non-metastatic or stable metastatic disease * chromogranin a elevation above normal range (confirmed by a second evaluation at least 1 week later) \[cut off levels will be \> 20 u/l for enzyme linked immunosorbent (elisa) assay and \> 100 ng/ml for immunoradiometric (irma) assay\] exclusion criteria: * patients who according to the investigator opinion are candidates to be treated immediately with chemotherapy (e.g. docetaxel) * first line treatment with antiandrogen in monotherapy * visceral metastasis * previous or concomitant treatment with a somatostatin analogue
a novel approach to lens subluxation

Conditions: Subluxation

Summary: evaluating new technique for treating patients with subluxation using specific laser type and new 6-0 proline fixating novel technique for the capsular bag

the management of a subluxated crystalline lens remains a challenge for anterior segment surgeons, largely due to the complex anatomical and functional changes in such cases. capsulaser is safe and effective tool in creating well centered ccc with consistent 360 degree iol coverage that ensures better lens stability and effective lens positioning . combined with using flanged 6-0 prolene sutures for scleral fixation of cionni rings, this technique addresses previous limitations by improving intraoperative control.

Eligibility criteria:
inclusion criteria: * lens subluxation with clear corneal media. exclusion criteria: * associated macular lesions.

Keywords: subluxation, capsulaser, prolene, cionni
open label extension study of nalbuphine hcl er in hemodialysis patients with uremic pruritus

Conditions: Uremic Pruritus; Pruritus

Summary: the primary objective of the study is to evaluate the overall safety of nalbuphine hcl er tablets during a treatment period of up to 24 weeks.


Eligibility criteria:
inclusion criteria: * subject completed participation in the tr02 study * subject is currently receiving in-center hemodialysis at the time of consent exclusion criteria: * subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study * subject received opiates on a daily basis during the 1 week prior to screening * other than the tr02 study drug, subject received any investigational drug within 4 weeks prior to screening * subject is a pregnant or lactating female

Keywords: uremic pruritus itch chronic itch nalbuphine
gait patterns in dual-task conditions in patients with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Summary: the investigators hypothesize a relevant impact of cognitive status over gait performance in patients with amyotrophic lateral sclerosis (als), contributing to poor mobility and representing a relevant risk for falls. the present observational, cross-sectional study on ambulatory patients with als will evaluate gait performance using different sets of dual-task conditions to demonstrate the importance of cognitive aspects in rehabilitation programs for these patients. the dual-task conditions to be assessed during gait performance will include: counting backwards by 3 (executive simple task); counting backwards by 7 (executive complex task); mnemonic recall of the rey's auditory verbal learning test (ravlt). patients' performance will be compared with a group of healthy controls with similar age and sex distribution in order to highlight the specific effects of the disease.


Eligibility criteria:
patient inclusion criteria: * age ≥ 18 years; * clinical diagnosis of als or other mnd phenotype; * able to walk unassisted for at least 1 minute consecutively; * oral and written informed consent to study participation. healthy control inclusion criteria: 1. age ≥ 18 years; 2. age and sex distribution similar to patients (age range: mean age of patients years ± 15 years); 3. able to walk unassisted for at least 1 minute consecutively; 4. oral and written informed consent to study participation. exclusion criteria an individual (either patient or healthy control) who meets any of the following criteria will be excluded from participation in this study: 1. diagnosis of dementia; 2. medical conditions or substance abuse that could interfere with cognition; 3. any (other) major systemic, psychiatric, neurological, visual, and musculoskeletal disturbances or other causes of walking inability.
castration-resistant prostate cancer and intra-prostatic hormonal status

Conditions: Prostate Cancer

Summary: the main objective of the study is to determine the intra-prostatic concentration of sexual steroids when castration resistance appears in castration-resistant prostate cancer patients compared to patients naif of hormonal treatment


Eligibility criteria:
inclusion criteria: * group 1: patients with a locally advanced prostate cancer naif of any hormonal treatment * group 2: patients with a castration-resistant prostate cancer resisting defined by a biological progression * group 2a: without radiotherapy * group 2b: with radiotherapy * affiliated to a social security scheme * having given a written consent. exclusion criteria: * patient unable to supply a written consent (patient not understanding french, under guardianship patient). * neuro-endocrine form or sarcomatoid form prostate cancer
testing an online intervention to improve parents' communication with gay and bisexual sons about sex and hiv

Conditions: HIV Infections

Summary: young men who have sex with men (msm) are at high risk for hiv infection in the united states, representing 80% of all infections among youth ages 14-24, and 92% of infections among boys ages 14-19. despite these risks, the field has not even one hiv prevention intervention shown to be effective in decreasing sexual risks or increasing hiv testing among adolescent msm (amsm). historically, reaching amsm for hiv prevention has been challenging, given their relative geographic isolation and lack of access to traditional gay congregating spaces (e.g., bars and many gay-related social networking websites). however, the investigators have developed a novel online platform for delivering interventions to parents of lgb youth that currently sees thousands of visitors each year. hiv prevention advocates have identified parents of amsm as an untapped resource for reducing hiv risk in this population. parent-child communication about sex has well-demonstrated associations with adolescent risk behaviors, and interventions with parents of heterosexual youth have been shown to be effective in increasing parent-adolescent communication, and thereby, reducing adolescent health risks. thus, the aim of the proposed study is to pilot test the efficacy of an online intervention to increase and improve parent communication with amsm about sexuality and hiv, with the ultimate goal of decreasing adolescent sexual risk and increasing hiv testing. this will be achieved by randomizing parents who come to seek resources on the investigators' existing website to receive either (a) a film designed to support parents of lgb youth, or (b) that film + the online communication intervention materials, and then gathering longitudinal, online data from parents in both study arms and their amsm sons over a 2-4 month period. it is hypothesized that parents in the intervention group will increase their communication with their sons about hiv and condoms.


Eligibility criteria:
inclusion criteria: * parent or legal guardian of a child with all of the following characteristics: 1. cisgender male 2. age 14-22 3. self-identify as gay or bisexual 4. lives in the same house with parent at least 2 days per week. exclusion criteria: * child with known hiv infection
long-term outcome in pediatric surgical bypass grafting after traumatic injury and tumor resection

Conditions: Child Health; Bypass Graft Occlusion

Summary: introduction: vascular bypass surgery in children differs significantly from adults. it is a rarely performed procedure in the setting of trauma and tumor surgery to facilitate limb salvage. beside the technical challenges to reconstruct the small and spastic vessels, bypass grafting should not impede growth of the extremity. the primary aim of this study was to assess long-term outcome after pediatric bypass grafting, in a single academic center, focusing on potential effects on limb development. methods: in this retrospective cohort analyses we included all pediatric patients undergoing vascular bypass grafting at the medical university of vienna between 2002-2017. all patients ≤ 18 years suffered a traumatic injury or underwent a tumor resection of the lower or upper limb, respectively. the youngest female patient was 0.4 years, the youngest male patient was 3.5 years.


Eligibility criteria:
inclusion criteria: * age \<18 years * planned vascular bypass grafting exclusion criteria: * age \>18 years * no vascular intervention
real-life evidence on stroke prevention in spaf

Conditions: Atrial Fibrillation (Prevention of Stroke)

Summary: to obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin k antagonists (vka) for stroke prevention in patients with non-valvular atrial fibrillation (spaf) in a real-life setting


Eligibility criteria:
inclusion criteria: * age ≥18 years on the day of the first prescription of the study drug (= index date) during study selection window * diagnosis of nvaf on start date of study or anytime during 365 days before this date * availability of follow-up at least 180 days after the date of the first prescription of study drug within selection window of study (exposure start date) * evidence of patient activity in the database during 90 days before the date of the first prescription of target drug within selection window. exclusion criteria: * patients with valvular af * prescriptions of oral anticoagulants (oacs): vka, dabigatran, rivaroxaban before index date * prescription of more than one oac on the index date or switch to another oac during the follow-up period * prescriptions of \< 15mg rivaroxaban at index date or during the follow-up period for patients in rivaroxaban cohort

Keywords: non-valvular atrial fibrillation (nvaf) pevention stroke
irony comprehension ability of chinese speaking patients with tbi

Conditions: Traumatic Brain Injury

Summary: this study aims at understanding irony comprehension ability of chinese speaking patients with tbi through a series of self-made stories. each story contains two characters having a conversation, and one of them would give a figurative (which is, ironic) or literal statement at the end of the story. the participants are asked to figure out its meaning.

the investigator plans to recruit tbi patients and control group whose gender and age accord with them, 15 people in each group. they would be asked to read the materials mentioned above displaying by a computer. it may take 30 minutes per time, and every participants only do once.

Eligibility criteria:
inclusion criteria: * above 20 years old * chinese speaking people * diagnosed as tbi patients for over 6 months * having no other neurological and mental related problems * able to read with or without assistive device like glasses exclusion criteria: * addicted to alcohol or drug morbid and postmorbid * having any communication disorders

Keywords: irony comprehension
national survey on gerd patients (adults and children)

Conditions: GERD (Gastroesophageal Reflux Disease)

Summary: to describe gerd digestive expression according to ages: - children (from 0 to 23 months) and (24 months and more)- adults (from 18 to 29 years old), (from 30 to 39 years old), (from 40 to 49 years old), (from 50 to 59 years old), (more than 60 years old)


Eligibility criteria:
inclusion criteria: * adults : - male or female \> or = 18 years old - with at least one gerd typical clinical sign (pyrosis and / or acid regurgitations).- not receiving any gerd treatment within the 3 previous months. * children :- male or female \< 18 years old - with gerd digestive clinical signs during the consultation (receiving treatment or not)- whose parents or legal guardian gave oral approval to the child participation in the survey. exclusion criteria: -

Keywords: gerd digestive expression ages
widefield fluorescence and reflectance imaging systems and oral tissue samples in monitoring participants at risk for developing oral cancer

Conditions: Erythroplakia; Fanconi Anemia; Lichen Planus; Oral Cavity and Lip Precancerous Condition; Oral Cavity Leukoplakia; Oral Neoplasm; Premalignant Lesion; Tobacco Use Disorder

Summary: this clinical trial studies widefield fluorescence and reflectance imaging, fluorescence spectroscopy, and tissue samples in regularly examining (monitoring) participants at risk for developing oral cancer. all tissue and cells are made of tiny particles. some of these particles give off small amounts of light. this light is called fluorescence. fluorescent imaging use instruments that shine different wavelengths (colors) of light in the mouth taking fluorescence pictures through a portable head light or by taking fluorescent and reflectance pictures through a dental microscope using a digital camera. fluorescent spectroscopy uses a small probe placed gently against the lining of the mouth and the tissue is exposed to small amounts of fluorescent light that is then collected with a special camera and a computer to be analyzed. checking mouth tissue samples under a microscope may also help detect abnormal cells. diagnostic procedures, such as fluorescence and reflectance imaging, fluorescence spectroscopy imaging, and tissue samples, may help doctors detect pre-cancer or early cancer when it may be easier to treat.

primary objectives: i. to compare images of oral mucosa, obtained at various wavelength combinations including 350 nm, 380 nm, 400 nm, and 450 nm excitation, to standard white light images, pathologic analysis of any biopsied tissue when available, and carcinogenic progression. outline: participants' oral cavities are inspected by a clinician using a standard white light headlamp. participants then undergo oral mucosa examination using wide-field reflectance and fluorescence imaging, and/or fluorescence spectroscopy imaging. standard oral brush biopsies are also performed and examined microscopically. participants may undergo repeated imaging procedures and biopsy during subsequent follow up visits.

Eligibility criteria:
inclusion criteria: * subjects with premalignant lesion, or potentially premalignant lesion, of the oral cavity mucosa (leukoplakia or erythroplakia) * patients with a history of head and neck cancer or oral premalignant disease but without any clinical evidence of disease * persons with any other condition (such as lichen planus, fanconi anemia, heavy tobacco use, etc) making them at higher risk for oral cancer development * patients with either pre-malignant or a history of oral cancer based on patient history and clinical presentations exclusion criteria: * subjects under the age of 18. * subjects that are unable or unwilling to give informed consent
evaluation of novel biomarkers to improve risk stratification and patient selection in implantable cardioverter-defibrillator (icd) therapy

Conditions: Ventricular Arrhythmias; Cardiac Death

Summary: implantable cardioverter-defibrillator (icd) therapy reduces mortality in patients with chronic heart failure and reduced left ventricular ejection fraction (lvef) \<36%. nevertheless, patient selection for icd therapy based on lvef and nyha functional class alone seems to have a low specificity and sensitivity: in 100 patients treated, the scd-heft study prevented 7 deaths in 5 years. therefore 93 patients have a risk of adverse effects, such as operation risk, infection, pneumothorax, lead dislocation, and inadequate icd therapy. on the other hand, patients with advanced or end stage heart failure might rather die off progressive heart failure death and thus not benefit from icd therapy. it therefore seems appropriate and necessary to improve the individualized risk stratification in these patients. the aim of this study is to evaluate multiple cardiac biomarkers in a model predicting ventricular arrhythmias in patients on icd therapy.

patients having or getting an icd in the dept. of cardiovascular medicine of the hannover medical school will be recruited in the next 2 years. blood samples of all patients will be obtained at inclusion and at 6 months follow-up. patients will be followed-up for 1-2 years after inclusion.

Eligibility criteria:
inclusion criteria: * patient meeting the current indications for primary or secondary prophylactic icd/crt-d therapy * age 18 years or older exclusion criteria: * patient unwilling to participate.

Keywords: implantable defibrillator ventricular arrhythmias cardiac death