Kornimate/medical-research-clean huggingface dataset:
appropriateness of antibiotic combination therapy for severe community-acquired pneumonia in south korea

Conditions: Severe Community-acquired Pneumonia (sCAP)

Summary: this study aims to provide high-level evidence for appropriate empirical antibiotic use tailored to the clinical reality in korea by conducting a randomized controlled trial comparing monotherapy with piperacillin/tazobactam and combination therapy with piperacillin/tazobactam plus a fluoroquinolone in patients with severe community-acquired pneumonia.


Eligibility criteria:
* inclusion criteria: * adult patients aged 19 years or older who visited the emergency department and were hospitalized. * findings consistent with pneumonia diagnosis, meeting all of the following criteria: * radiologic evidence of pulmonary infiltration on chest x-ray or chest ct. * at least two or more of the following clinical signs: i) body temperature ≥38°c or \<36°c ii) white blood cell count ≥11,000/µl or \<4,000/µl iii) presence of purulent sputum or bronchial secretions * within 24 hours of admission, the patient meets one major criterion or three minor criteria according to ats/idsa classification: * major criteria: i) invasive mechanical ventilation ii) use of vasopressors (vasopressor-dependent septic shock) * minor criteria: i) respiratory rate ≥30 breaths/min ii) pao2/fio2 ≤ 250 iii) multilobar infiltrates iv) confusion or disorientation v) bun ≥20 mg/dl vi) wbc \<4,000/mm³ vii) platelet count \<100,000/mm³ viii) hypothermia (temperature \<36°c) ix) hypotension requiring aggressive fluid resuscitation * exclusion criteria: * transferred from another hospital after \>48 hours of hospitalization * died within 72 hours of hospital admission * transferred to another hospital within 14 days of admission * pneumonia occurring after \>48 hours of mechanical ventilation, including home ventilators * detection of influenza or sars-cov-2 virus within 7 days of hospitalization * identified non-pneumonia infection requiring antibiotics within 72 hours of admission * detection of piperacillin/tazobactam-resistant enterobacterales, pseudomonas spp., or acinetobacter spp. in respiratory or blood cultures within the past 90 days * antibiotic-related adverse events observed within 72 hours of assigned treatment, requiring discontinuation or change of antibiotics
ablative fractional laser for sclerotic gvhd-associated joint contractures

Conditions: Subjects With Severe, Refractory Sclerotic Skin Changes

Summary: graft versus host disease (gvhd) is a common complication of allogeneic stem cell transplant.chronic gvhd is characterized by skin thickening and tightening. advanced sclerosis can lead to reduced range of motion and incapacitating joint contractures. once present, there are few therapeutic options. we will treat sclerosis and limb contractures with an ablative fractional laser, a device fda-approved for scar treatment. this approach has successfully treated contracturesdue to burn scars.


Eligibility criteria:
inclusion criteria: * subjects must be able to give informed consent * all adult patients (18 years of age or older) severe sclerotic skin changes of chronic graft versus host disease meeting a score of 3 on the nih consensus criteria for organ scoring of chronic gvhd, * a score defined by deep sclerotic features with hidebound skin which cannot be pinched together, resulting in impaired motion. * according to the nih criteria, the patient need not have widespread cutaneous gvhd; hidebound skin or impaired mobility receive a score of 3 (highest score). * demonstrable range of motion limitations and joint contractures due to sclerotic gvhd across a specific joint / limb amenable to laser therapy must be present. - - patients must note an inability to bend the joint (e.g. foot, wrist, elbow) freely which compromises the ability to perform specific tasks (e.g. walking up or down stairs, grabbing / making a fist, lifting or raising thearms over the head). as these functional limitations are by their nature subjective (and nih scoring criteria are themselves subjective) determination of eligibility will be made by the investigator. * ecog performance status shall be 0-3 exclusion criteria: * persons unable to provide informed consent pregnant or nursing women, or children under age 18 * active infections such as herpes simplex virus (hsv) acute, untreated medical problems such as poorly-controlled diabetes, decompensated heart failure, etc. * there are no specific contraindications to use of the laser based on skin pigmentation, sun sensitivity, history of keloids, use of specific medications, etc. * appropriateness for trial entry will be determined on an individual basis by the study investigators. * patients with ecog performance status 3 will be excluded. * patients with anc 1500,plt 50, or hgb 8.0 will be excluded.
post-operative pain relief for paediatric inguinal-scrotal surgery

Conditions: Hernia, Inguinal

Summary: two methods of pain control in children undergoing surgery on the groin and scrotum are caudal injection (a form of epidural) with local anaesthetic, and a regional nerve block (an injection of local anaesthetic around the nerves supplying the area). a pilot study at our hospital showed a significant decrease in post-operative pain and nausea and vomiting in these two methods when compared to intravenous morphine and local anaesthetic to the wound. one potential side effect from caudal injections is temporarily decreased motor power in the legs due to the local anaesthetic - it is thought that this might be overcome using a more dilute solution of local anaesthetic along with clonidine. this study is to demonstrate that this method is as effective as the use of a regional nerve block.


Eligibility criteria:
inclusion criteria: * children undergoing day case elective inguinal-scrotal surgery exclusion criteria: * contraindication to technique * significant comorbidities * patient/parent refusal
study of afp464 +/- faslodex in er + breast cancer

Conditions: Breast Neoplasm

Summary: afp464 is an investigational agent which may be effective in the treatment of cancer. the purpose of this study is to test the efficacy of afp464 +/- faslodex in er+ breast cancer patients.

this is a randomized, open-label study. patients will be randomized in a 1:1 ratio to single arm afp464, or afp464+faslodex. patients will be treated until disease progression is noted.

Eligibility criteria:
inclusion criteria: * proven breast cancer, er+ status; progression on an aromatase inhibitor; measurable disease or evaluable disease with serum ca27.29\>=50 u/ml; adequate bone marrow, liver and renal function; dlco grade 0 or 1. exclusion criteria: * her2 positive, thoracic radiotherapy or symptomatic pulmonary disease, brain metastases,
advancing the patient experience in chronic obstructive pulmonary disease (apex copd)

Conditions: Chronic Obstructive Pulmonary Disease (13645005)

Summary: apex copd is registry to provide a mechanism to standardize, store and utilize data to enable greater power to answer key research questions, and to improve patient outcomes in copd primary care.

in the process of creating of a high-quality longitudinal dataset combining copd templates and patient reported information and outcome (prio) to evaluate outcomes the apex copd registry supports changes and improvements in medical practice and deliver high quality research through the following mechanisms: * templates integrated into the primary care clinical systems to support standardization of care and data over time. * informing doctors at the point of consultation about the status of their patients through data-driven feedback. * pre-filled electronic data templates from existing ehr data and questionnaires to reduce administrative burden for primary care clinicians (pcc). * engaging primary care clinicians in ongoing quality improvement initiatives directly at the point of care. * research publications regarding treatment effectiveness and associated risk in mild to moderate copd, reason for therapy switch/escalation and hidden undiagnosed and untreated copd patients in primary care. * a strong network of primary care clinicians caring for patients with copd in the us to drive the initiative and ensure impact on clinical practice through educational events, academic organizations and research outputs. the apex copd steering committee (sc) comprise of collective clinical expertise, scientific knowledge and experience in ehr, databases and research, forming an essential element of the apex copd registry. the sc plays an essential role in the development and governance of the apex copd registry, representing the sites participating, and providing the expertise necessary to implement and drive the initiative. within this committee a smaller management group guides the operational aspects of the registry. the research database uses the observational medical outcomes partnership (omop) v5 common data model (cdm) and the omop terminology will be updated at least bi-annually. standardized omop concept ids will utilize snomed, rxnorm and may be adjusted to improve data compatibility with other opc copd databases.

Eligibility criteria:
inclusion criteria: * diagnostic code for copd or copd monitoring review code prior to or at consultation * aged ≥35 years at copd diagnosis exclusion criteria: * patients receiving hospice care * patients being actively treated for a cancer diagnosis (not skin)

Keywords: chronic obstructive pulmonary disease chronic obstructive lung disease chronic obstructive airway disease registry electronic health record electronic medical record patient reported information and outcomes treatment therapy
renal considerations in the heat stress recommendations

Conditions: Hot Weather; Adverse Effect; Kidney Dysfunction; Kidney Injury; Hyperthermia; Dehydration

Summary: an epidemic of chronic kidney disease is occurring in laborers who undertake physical work outdoors in hot conditions. the reason for this is unknown, but may be related to kidney dysfunction caused by increases in body temperature and dehydration. the current heat stress recommendations for workers were not developed with regards for kidney health. the purpose of this study is to determine if the current recommendations protect against kidney dysfunction.


Eligibility criteria:
inclusion criteria: * men and women * 18-44 y old * body mass index ≤35.0 kg/m2 * self-reported to be healthy. exclusion criteria: * not within defined age range * estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73m2 * deemed highly active according to the physical activity questionnaire (i.e., \>3500 met\*min/wk) * body mass index \>35.0 kg/m2 * current or history of any renal disease, heart disease, stroke, immune or autoimmune disease, and/or gastrointestinal disease/surgery * hypertension during screening (systolic blood pressure \>139 or diastolic blood pressure \>89) * using medications that blunt the physiological response to exercise (e.g., beta blockers) * prescription medication with a known side effect of impaired temperature regulation or fluid balance (e.g., diuretics) * positive pregnancy test at any time during the study or breast feeding * current tobacco or electronic cigarette use or consistent use within the last 2 years * inability to safely complete the peak oxygen uptake test
a safety and tolerability study of an investigational drug, aln-ttrsc02, in healthy subjects

Conditions: Transthyretin-mediated Amyloidosis (ATTR Amyloidosis)

Summary: the purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of aln-ttrsc02 in healthy subjects.


Eligibility criteria:
inclusion criteria: * male and female subjects, age 18 to 65 years, inclusive. * body mass index (bmi) ≥18.0 kg/m2 and ≤30 kg/m2 assessed at screening. * no clinically significant health concerns, as determined by medical history and physical examination, in the opinion of the investigator. * women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception, willing and able to comply with the study requirements and to provide written informed consent. * for japanese cohorts, subjects of japanese descent are defined as people carrying a japanese passport, descendants of 4 japanese grandparents, and have not been outside japan for more than 5 years. exclusion criteria: * clinically relevant history or presence of respiratory, gastrointestinal, renal, cardiovascular, hepatic, hematological, lymphatic, neurological, psychiatric, musculoskeletal, genitourinary, immunological, and other inflammatory diseases, or dermatological or connective tissue diseases or disorders. * active serious mental illness or psychiatric disorder. * clinically significant ecg abnormalities. abnormal for ast/alt and any other clinical safety laboratory result considered clinically significant. * known history of allergic reaction to an oligonucleotide or galnac. * history of intolerance to subcutaneous injection.

Keywords: ttr-mediated amyloidosis amyloidosis, hereditary amyloid neuropathies, familial familial amyloid polyneuropathies amyloid neuropathies amyloidosis, hereditary, transthyretin-related familial amyloidosis rnai therapeutic
a 2-part, phase 1, single and multiple ascending dose study to assess the safety, pharmacokinetics, and pharmacodynamics of cat-2054 in healthy subjects

Conditions: Hypercholesterolemia

Summary: this is a 2-part, phase 1, placebo-controlled, double-blind, randomized, single and multiple ascending dose study. cat-2054 will be administered either as an uncoated capsule (cat-2054) or a coated capsule (cat-2054-c). in part a, cat-2054 or placebo is administered as a single dose in a fasting state at 4 dose levels; at 3 dose levels, subjects will return for a second dose of the study drug after a high-fat meal. additionally, at 1 dose level, cat-2054-c or placebo will be administered as a single dose in a fasting state, and subjects will return for a second dose of the study drug after a high-fat meal. in part b, cat-2054 will be administered as multiple ascending doses at 4 dose levels for 14 consecutive days. in selected cohorts, cat-2054, cat-2054-c or cat-2054 with atorvastatin will be dosed to assess safety in anticipation of future clinical trials.


Eligibility criteria:
inclusion criteria: * provision of written informed consent before any study-specific procedure * good health as determined by medical history, physical examination, vital sign measurements, ecg, and clinical laboratory measurements * satisfies one of the following: 1. females not of childbearing potential: non-pregnant and non-lactating surgically sterile or postmenopausal 2 years or less with a follicle-stimulating hormone assessment greater than or equal to 40 iu/l 2. males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose * for part b only, measured at screening: fasting ldl-c ≥100 mg/dl; or (cohort b6 only) fasting ldl-c ≥130 mg/dl * body mass index (bmi) between 18 and 30 kg/m², inclusive, for part a and between 18 and 40 kg/m², inclusive, for part b, and body weight \>50 kg at screening exclusion criteria: * use of prescription drugs or non-prescription drugs including herbals, and dietary supplements (including multivitamins and any product containing niacin or omega-3 fatty acids above the recommended daily allowance) within 2 weeks before dosing. additionally for part b only, use of any lipid-regulating prescription drug, non-prescription drug, herbal, or dietary supplement within 6 weeks before dosing * clinically significant disease that requires a physician's care and/or would interfere with study evaluations * clinically significant electrocardiogram (ecg) abnormalities or laboratory results as assessed by the investigator, such as qtcf \>450 * use of any investigational drug or participation in any investigational study within 30 days prior to screening or 5 half-lives of the study agent, whichever is longer
prevalence and risk factors of black tooth stains

Conditions: Dental Plaque

Summary: to assess the prevalence of black tooth stains and their relation with caries experience in the primary dentition of 3-5-year-old children.

tooth discoloration is frequently seen by dental practitioners and is considered an aesthetic problem. there are two types of teeth discoloration; intrinsic discoloration which is related to intrinsic factors such as congenital and inherited conditions and extrinsic discoloration which occurs due to the formation of pigments on the enamel surface (prskalo et al., 2017). black stain is a specific type of external tooth discoloration. it is clinically diagnosed as dark dots on the gingival third of the tooth that may coalesce and form a complete dark line following gingival contour or can also impregnate pits, fissures, and grooves (frança-pinto et al., 2012). black stains are a common finding in children and are seen equally in both genders (zyła et al., 2015). when children's smiles do not fit the esthetic criteria, it can have negative social and psychological consequences causing embarrassing situations for the child, including school bullying. their guardians may also be affected as people could judge it as bad oral health and question the care given to these children .(fernando pessoa, n.d.) the etiology of black stains is multifactorial . chromogenic anaerobic bacteria have been considered one of the etiological factors by their production of hydrogen sulfide that interacts with iron present in saliva and forms insoluble ferric sulfate which is the main component of these pigments (elelmi et al., 2021). rational: although black stains have been considered a protective factor against caries, they are considered a common aesthetic problem. according to the systematic review of asokan et al., 2020, there is conflicting data on the relation between tooth stains and dental caries as some studies showed a positive association between black stains and caries and other studies showed a negative association between them, and therefore, further studies are needed to completely understand the nature, risk factors of black stains and their relation with caries experience.

Eligibility criteria:
inclusion criteria: * • 3-5 years old preschool children * children with primary dentition exclusion criteria: • children whose parents refuse signing informed consent

Keywords: black stains
study of telotristat etiprate (lx1606) in participants with symptomatic carcinoid syndrome not managed by stable-dose octreotide therapy

Conditions: Carcinoid Syndrome

Summary: the purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (lx1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.


Eligibility criteria:
inclusion criteria: * males and females, aged 18 and older * biopsy-proven metastatic carcinoid tumor of the gastrointestinal (gi) tract with disease extent confirmed by computed tomography (ct), magnetic resonance imaging (mri), or radionuclide imaging * symptoms not managed by stable-dose long-acting octreotide therapy (≥4 bowel movements per day) * ability to provide written informed consent exclusion criteria: * ≥12 high volume, watery bowel movements per day associated with a clinical syndrome of volume contraction, dehydration, or hypotension compatible with a "pancreatic cholera"-type clinical syndrome * sponsor-unacceptable clinical laboratory values for hematology and liver function tests at screening * karnofsky status ≤70% - unable to care for self * surgery within 60 days prior to screening * a history of short bowel syndrome * life expectancy \<12 months * history of substance or alcohol abuse within 2 years prior to screening * previous exposure to a tryptophan hydroxylase (tph) inhibitor * administration of any investigational drug within 30 days of screening or any therapeutic protein or antibody within 90 days of screening
chronic non-inflammatory pains in rheumatopediatrics

Conditions: Juvenile Idiopathic Arthritis

Summary: the purpose of this study is to determine the frequency of chronic pain in adolescent with juvenile idiopathic arthritis, especially when the disease is inactive or with minimal activity. secondary objectives are, first to determine intensity of pain and its repercussion in daily life and second to determine risk factor of chronic pain.

juvenile idiopathic arthritis is the most frequent pathology in paediatric rheumatology clinic. pain is an important symptom in paediatric rheumatology. it is actually poorly studied and is not evaluate in disease activity score like the juvenile arthritis disease activity score (jadas). it is source of handicap, social and psychological distress and greatly contribute to poor quality of life. chronic pain is frequently multifactorial, even in inflammatory disease. in adult population, rheumatologists have shown an association between inflammatory disease like spondylarthritis or rheumatology polyarthritis and fibromyalgia. there is no specific data on chronic pain in juvenile idiopathic arthritis. pain is mostly evaluated by the visual analogue scale (vas) with no evaluation of pain repercussion on daily life or its chronicity. this study's primary objective is to determine the frequency of chronic pain and its relationship with disease activity. secondaries objectives are to determine repercussion of pain in daily life, and risk factor of chronic pain. to responded to this objective, we will conduct a transversal study in a paediatric rheumatology refence centre in necker-enfants malades hospital. we will include all patients between 12 and 18 years old followed in our centre for any type of juvenile idiopathic arthritis. patients will be evaluated as usual by their paediatrics rheumatologist during a follow-up consultation or hospitalisation with the used of the clinical jadas. patient accepting to participate the study will be given a paper questionnaire evaluating chronic pain, its repercussion, anxiety (by the used of the revised children's manifest anxiety scale (rcmas score)), depression (by the used of the children's depression inventory (cdi score)), sleepiness (by the used of the pediatric daytime sleepiness scale (pdss score)) and quality of life (by the used of the measurement model for the pediatric quality of life inventory (pedql score)).

Eligibility criteria:
inclusion criteria: * child from 12 to 17 years old * follow-up to necker hospital by a rheumatologist at the reference center for juvenile idiopathic arthritis (raise), regardless of the form * not opposed to participating in the study exclusion criteria: no exclusion criteria

Keywords: juvenile idiopathic arthritis chronic pain anxiety depression sleepiness quality of life