Kornimate/medical-research-clean huggingface dataset:
interaction of salivary proteins and polyphenols

Conditions: Diet Habit; Diet Modification; Taste, Altered; Saliva Altered

Summary: participants will be chosen through an initial sensory test to find high and low-perceivers of astringency. selected participants will drink a chocolate milk or milk substitute beverage for one week each with washout weeks in between. at the end of each week participants will taste and rate multiple beverages for their astringency and other sensory properties. participants will provide saliva samples weekly for proteomic analysis and (potentially) analysis of polyphenols. participants will also be asked to provide a 24 hour dietary recall once per week. data will be analyzed to determine if there is a relationship between polyphenol exposure, astringency ratings, and salivary protein composition.


Eligibility criteria:
inclusion criteria: * high or low perceivers of astringency (from initial screening) exclusion criteria: * current smokers (within 30 days), dairy/nut/cocoa allergies, piercings in mouth, mid-range perceiver of astringency, issues with taste, smell, swallowing or choking.
randomized study of succimer (dimercaptosuccinic acid) on growth of lead-poisoned children

Conditions: Lead Poisoning

Summary: objectives: compare growth of lead-poisoned children receiving succimer (dimercaptosuccinic acid; dmsa) plus standard treatment to those receiving standard treatment only.

protocol outline: this is randomized study. patients are randomized to receive succimer in addition to standard treatment (arm i) or standard treatment only (arm ii). succimer is administered orally 3 times a day for 7 days, then twice daily for 19 days. patients may receive up to 3 courses. standard treatment consists of a medical history and physical examination, environmental assessment with modification to reduce lead exposure, dietary modifications to decrease lead absorption, the use of a daily multivitamin and mineral supplement with iron, developmental screening and intervention, and frequent follow up of lead levels. if blood lead level rises above 45 mcg/dl, patient receives succimer regardless of treatment arm originally assigned. patients are followed every 3-4 weeks for 2 months, then every 3 months for 6 months, and then every 6 months thereafter.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- asymptomatic children with confirmed venous blood lead of at least 20 mcg/dl and less than 45 mcg/dl children with blood lead of 45 mcg/dl or greater are not randomized in this study since they probably will receive succimer regardless of being enrolled in this study --patient characteristics-- other: no contraindications to the use of succimer (i.e., allergy or a lack of lead safe environment in which to live during chelation)

Keywords: environmental/toxic disorders lead poisoning rare disease
myeloproliferative neoplasms (mpns) patient registry

Conditions: Primary Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia; Mastocytosis; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Leukemia, Myelomonocytic, Juvenile; Chronic Eosinophilic Leukemia-not Otherwise Specified; Myelodysplastic-Myeloproliferative Diseases; Neoplasms; Leukemia, Myelomonocytic, Chronic

Summary: the mandate of this mpn registry is to collect clinical information, including molecular results, from consenting patients with a variety of mpns at different time points during the course of their disease.

the myeloproliferative neoplasms (mpns) are a group of rare hematological malignancies in which the bone marrow cells that produce the body's blood cells develop and function abnormally. despite the gains that have already been made in understanding and treatment of mpns there is much that can still be learned. this registry will establish a clinical annotation database would help to better understand this group of diseases and to more effectively assign individual patients to the optimal therapy and so, improve their outcomes. this project will provide new insights on the molecular profiling of patients with mpn. it will be used as future resource for observational studies related to mpn. the registry involves the collection of clinical information from patients with diagnosis of mpn at different time points during the course of their disease. the clinical data is collected following written informed consent from the hematologic malignancy tissue bank (uhn reb 01-0573c). data collected includes: a range of clinical measures, disease-associated factors, details of treatment and its results, complications during treatment, molecular and cytogenetic data, symptom assessment and survival outcome (up to 10 years). data will be collected prospectively and retrospectively, in both cases after obtaining written informed consent as per the study standard operating procedure (sop).

Eligibility criteria:
inclusion criteria: diagnosis of one of the following myeloproliferative neoplasms (mpns): * atypical cml (acml) * chronic eosinophilic leukemia-not otherwise specified (cel, nos), * chronic myelomonocytic leukemia (cmml) * chronic neutrophilic leukemia (cnl), * essential thrombocythemia (et), * juvenile myelomonocytic leukemia (jmml), * mastocytosis, mpn unclassifiable * mpn/mds unclassifiable, * primary myelofibrosis (pmf), * post-essential thrombocythemia myelofibrosis (post-et mf), * post-polycythemia vera mf (post-pv mf) * refractory anemia with ringed sideroblasts associated with marked thrombocytosis (rars-t) exclusion criteria: * none

Keywords: myeloproliferative neoplasm myelodysplastic syndrome registry leukemia bone marrow diseases hematologic diseases neoplasms
care ecosystem: navigating patients and families through stages of care, extension trial

Conditions: Dementia; Alzheimer Disease; Dementia, Vascular; Lewy Body Disease; Frontotemporal Lobar Degeneration; Memory Disorders

Summary: this is an extension trial of a prior trial (nct02213458). both persons with dementia (pwd) and their caregivers were enrolled as dyads. the purpose of this randomized clinical trial is to evaluate the benefits of a program that supports model care for pwd and their caregivers. whereas the prior trial only delivered care and examined outcomes up to 12-months, this trial extends care and outcome measurement for 5 years or until death, and includes all dyads where the caregiver reported high caregiver burden (zarit-12 greater than or equal to 17) at pre-randomization baseline for the original trial. participants were recruited from california, nebraska and iowa. participants determined to be eligible were consented and randomized into one of two groups. two thirds of dyads were enrolled into navigated care that provided them with phone-based assistance in meeting important benchmarks in their care, for example completion of legal and financial planning and strategies for minimizing caregiver burden. one third of dyads were enrolled to a control group, entitled survey of care. outcomes were unchanged from the original trial except for the addition of time to long term care placement and are detailed below.


Eligibility criteria:
this study will enroll patients as well as their primary caregivers as research participants. inclusion criteria for patient participants: * patient has a diagnosis of dementia with a progressive course * patient has a primary caregiver (identified as having primary responsibility for patient) that is eligible for and agrees to join the study * patient is covered by medicare or medi-caid or is medi-pending * patient is expected to live at least 3 months based on assessment by the referring provider, the patient's primary care provider, or medical record review * patient speaks english, cantonese, or spanish * patient lives in california or nebraska or iowa * patient is age 45 or older inclusion criteria for caregiver participants: * caregiver has primary responsibility for dementia patient that is eligible for and agrees to join the study * caregiver speaks english, cantonese, or spanish * caregiver is a legal adult * zarit-12 caregiver burden score greater than or equal to 17 at pre-randomization (baseline); this criteria is specific to this extension trial exclusion criteria: * patient resides in a nursing home or skilled nursing facility at time of enrollment * participant is enrolled in a similar clinical trial that precludes their participation in the investigator's trial * patient is pregnant

Keywords: pragmatic clinical trial family caregivers patient care management
predictive factors on the results of epidural adhesiolysis in patient with chronic spinal pain

Conditions: Pain, Chronic

Summary: the primary aim of this exploratory study was to determine the demographic, clinical, and technical factors associated with treatment outcome, to create a better select treatment candidates.


Eligibility criteria:
inclusion criteria: * patients in whom percutaneous epidural lysis of adhesions was performed exclusion criteria: * nonadhesiolytic procedure * lack of follow-up * incomplete outcome data
efficacy and safety of eyetronix flicker glasses to the treatment of anisometropic amblyopia

Conditions: Amblyopia, Anisometropic

Summary: to evaluate the efficacy and safety of eyetronix flicker glassess therapy in treating anisometropic amblyopia.

a total of 176 children with anisometropic amblyopia, aged 4 to 13 years, will randomize to receive patching or eyetronix flicker glasses treatment in a 1:1 ratio.eyetronix flicker glasses, a lightweight spectacle frame with liquid crystal lenses that provide direct square-wave alternating occlusion, will be used at a pre-programmed temporal frequency. patching is a traditional treatment of amblyopia. the best corrected visual acuity, contrast sensitivity, binocular function,visual evoked potential and functional mri will be measured at baseline and follow-up visits to assess the improvement of amblyopia.feedback information from the questionnaires will be used to evaluate the compliance and adverse effects.

Eligibility criteria:
inclusion criteria: 1. aged from 4 to 13 years old 2. the best corrected visual acuity in the amblyopic eye is no more than 0.1logmar, with two lines or more of difference between the two eyes 3. anisometropia is defined as an inter-ocular spherical refractive error difference of 1.00 d or more or a cylindrical difference of 1.50 d or more. 4. no amblyopia treatment one month prior to the study except refractive correction. 5. myopia is less than -6.00d or hyperopia is less than +9.00d, strabismus was less than 20 prism diopters 6. willing to participate in this study and be able to follow up on time exclusion criteria: 1. ocular disease and other disease that have an influence on the visual acuity 2. history of ocular surgery that have an influence on the visual acuity 3. the patient is receiving other amblyopia treatment except refractive correction 4. a family or personal history of seizures 5. the patient is using some medicine that may have an influence on visual acuity
immunogenicity and reactogenicity of dtpa-hbv-ipv/hib, compared to dtpa-hbv-ipv and hib administered separately

Conditions: Hepatitis B; Diphtheria; Haemophilus Influenzae Type b (Hib); Poliomyelitis; Pertussis; Tetanus

Summary: this study will assess the immunogenicity and safety of glaxosmithkline (gsk) biologicals' (formerly sb biologicals') dtpa-hbv-ipv/hib (infanrix hexa™) vaccine compared with separate administration of dtpa-hbv-ipv (infanrix penta™) and hib (hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.


Eligibility criteria:
inclusion criteria: * a male or female 3 months of age at the time of the first vaccination. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure. exclusion criteria: the following criteria should be checked at the time of study entry. if any apply at the time of study entry, the subject must not be included in the study: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination. * administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after. * previous vaccination against diphtheria, tetanus, pertussis, hepatitis b, polio and/or hib disease. * history of /or intercurrent diphtheria, tetanus, pertussis, hepatitis b, polio and/or hib disease or infection. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin b. * major congenital defects or serious chronic illness. * history of seizures or of any neurological disease at study entry. * administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period. * acute disease at time of enrolment

Keywords: combination vaccine dtpa-hbv-ipv hib
combination of nitrous oxide 70% with fentanyl intranasal for procedural analgosedation in children

Conditions: Inhalation of Nitrous Oxide; Opioid Analgesic Adverse Reaction; Pain

Summary: this study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for analgosedation for short and painful procedures in children.

nitrous oxide 70% (n20 70%) combined with 30% oxygen meets many criteria of an ideal pain medication for procedural analgosedation in children. at the emergency department of the children's hospital of zurich, switzerland, n20 70% is regularly used for short and painful orthopaedic procedures, mostly for reduction of dislocated forearm or finger fractures. the analgesic efficacy of n20 70% still remains controversial. therefore, all children who are eligible for n20 70% receive additionally either fentanyl or placebo intranasal and then their behavior, level of sedation and adverse events are measured during the painful procedure. the hypothesis is that a combination of n20 70% and fentanyl intranasal is not significant better than n20 70% combined with basic analgetics.

Eligibility criteria:
inclusion criteria: * indication for nitrous oxide 70% application * boys/girls aged 2-16 years * informed consent exclusion criteria: * due to language barrier no sufficient communication possible to explain the study * incompatibility to fentanyl sintetica * incompatibility to morphinomimetics
iv ibuprofen vs ketorolac in post operative pain in colorectal cancer surgeries in obese patient

Conditions: Ibuprofen; Ketorolac; Colorectal Cancer

Summary: the aim of this study is to assess the efficacy of iv ibuprofen and ketorolac in the management of postoperative pain in obese patients following abdominal cancer surgery.

colorectal cancer is the third most common cancer in the world, after lung and breast cancer, and the 4th most reported cause of cancer death, reporting about 8.0 % of all cancer deaths according to the who, egypt was ranked the 18th regarding the prevalence of obesity, and deaths attributable to non-communicable diseases represent about 71% of the total mortality burden.data obtained from the past 25 years suggest that the obesity is a cause of nearly 14% of cancer deaths in men and up to 20% of cancer deaths in women. most of cases experience moderate to severe pain after colorectal surgery, so effective and individualized analgesia required after colorectal surgery, as pain response to surgery is not predicted. opioids are an effective analgesic for moderate to severe pain, although their efficacy is limited by adverse effects including respiratory depression, failure to reduce pain caused by tissue inflammation, nausea, emesis, drowsiness, moderate sedation, pruritus, urinary retention and ileus. regional anesthesia can be an alternative to opioids but according to multiple studies it was associated with technical difficulties and higher failure rates in obese patients. ibuprofen is a nonselective inhibitor of cyclooxygenases (cox) enzymes, the inhibition ratio of cox-1 to cox 2 of ibuprofen is 2,5:1 that has a low risk of bleeding or gastrointestinal problems, while other nsaid as for example ketorolac have an inhibition ratio of 330:1 for cox-1 to cox-2 , reason for a high risk of side effects , therefore its use is controversial in most of perioperative settings. ketorolac 10 and 20 mg and ibuprofen 400 mg have the same analgesic effect that was significant by hour 1 and persisted for 5-6 hours for each active medication.

Eligibility criteria:
inclusion criteria: * asa class ii. * age ≥ 18 and ≤ 65 years. * patients undergoing midline abdominal incision for colorectal cancer surgery. * body mass index (bmi) \>30 kg/m2. exclusion criteria: * renal and hepatic insufficiency. * unstable cardiovascular disease. * history of psychiatric and cognitive disorders. * patients allergic to medication used. * asthmatic patients. * peptic ulcer patients. * patients on regular opioid consumption. * history of allergy or hypersensitivity to any component of ibuprofen, other nsaids, opioids or cox- 2 inhibitors. * subjects with active significant anemia, history of asthma .
randomized trial of risedronate to prevent bone loss in renal transplant recipients.

Conditions: Renal Transplant Osteodystrophy

Summary: patients with kidney failure have underlying bone disease at the time of transplant. fractures of various bones can be as high as 22%. medication required for the transplant plays a role in bone loss. bisphosphonates are used in the general population to treat bone loss of osteoporosis and steroid-induced bone loss. while previous studies, using various bisphosphonates, have shown preservation of bone mineral density in renal transplant recipients, we have demonstrated that pamidronate, a second generation bisphosphonate, is associated with low bone turnover while still preserving bone mineral density. improved bone mineral density is associated with decreased fracture risk in the general population, while low bone turnover may be associated with increased fracture in dialysis patients. the purpose of this study is to determine whether risedronate, a third generation bisphosphonate, is effective in preserving bone density when given prophylactically following renal transplantation and whether it is associated with low bone turnover at one year following renal transplantation.

participants who receive a living donor kidney transplant undergo a bone biopsy at the time of kidney transplant and after one year of protocol. once adequate kidney function is established, both groups take by mouth a weekly capsule (the control group has a placebo; the treatment group has risedronate 35 mg). both groups undergo baseline, 6 month and 12 month dual energy x-ray absorptiometry (dexa) bone mineral density scans. both groups undergo bone hormonal studies at regular intervals.

Eligibility criteria:
inclusion criteria: * adults with end stage renal disease who are undergoing living donor kidney transplantation

Keywords: renal transplant post-transplant osteoporosis
non-interventional study of seroprevalence of pre-existing antibodies against adenovirus-associated virus vector (aav9) and the progression of disease in patients with plakophilin 2 (pkp2)-associated arrhythmogenic right ventricular cardiomyopathy (arvc)

Conditions: Arrhythmogenic Right Ventricular Cardiomyopathy

Summary: this is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to aav9 used for gene therapy in a population of patients with pkp2 gene-associated arvc. participation from all patients is encouraged regardless of interest in or eligibility for gene therapy.

patients will receive standard of care treatments and assessments under the care of their healthcare provider. biologic samples will be collected annually to measure cardiac and other related biomarkers. clinical and observational data will be collected prospectively for up to 5 years from the date of enrollment, or until the patient withdraws consent/assent, undergoes heart transplantation, or dies. if consent is provided, there may be a one-time sample collection to evaluate genetics for research purposes. quality of life (qol) questionnaires will be used to assess a patient's wellbeing and quality of life. if not included as part of a patient's standard of care, diagnostic holter (or equivalent) monitoring will be required annually. no investigational product will be administered. participation from all patients is encouraged regardless of interest in or eligibility for gene therapy.

Eligibility criteria:
inclusion criteria: * ages 14-65 years, inclusive, at the time of consent * pathogenic or likely pathogenic pkp2 gene mutation * diagnosed with arvc and meet 2010 modified task force criteria for arvc as affected. * functioning icd exclusion criteria: * currently receiving systemic immunosuppressive therapy, cytotoxic chemotherapy, immunoglobulin therapy or monoclonal antibody therapy * history of clinically significant liver disease, hepatitis b virus, hepatitis c virus, human immunodeficiency virus, or tuberculosis infection * previously dosed with any investigational or approved gene therapy product at any time * concurrent participation in another interventional clinical trial unless approved by the sponsor. participation in a noninterventional study may be allowed at the investigator's discretion. * history of cardiac transplant.

Keywords: pkp2 mutation arrhythmogenic right ventricular cardiomyopathy (arvc) arrhythmogenic cardiomyopathy (acm) pkp2-associated arvc pkp2-arvc pkp2-acm adeno associated virus (aav) adeno-associated virus serotype 9 (aav9) gene therapy gene transfer genetic cardiomyopathy heart failure
relationship of retinal and visual cortex structure and visual acuity after congenital cataract surgery

Conditions: Congenital Cataract

Summary: to evaluate the influence of the visual acuity after congenital surgery on the retinal and visual cortex structure.

according to the visual acuity after congenital cataract surgery, 30 patients are divided into 3 groups.sd-oct and mri were used to measure the parameters of the retina and the visual cortex, to compare the differences between different groups, and to analyze the relationship between the structure of the retina and the visual cortex and visual acuity.

Eligibility criteria:
inclusion criteria: * age of 4-60 years * congenital cataract surgery is planned * the operation was successful without any complications * can cooperate well with oct and mri examinations exclusion criteria: * intraoperative and postoperative complications include glaucoma, retinal, corneal, or refractive medium diseases * behavioral, cognitive impairment * developmental delay

Keywords: amblyopia mri sd-oct visual acuity retinal structure visual cortex structure