Kornimate/medical-research-clean huggingface dataset:
a phased-implementation feasibility and proof-of-concept study to assess incorporating the nida ctn common data elements (cdes) into the electronic health record (ehr) in large primary care settings ("cde-ehr-pc" study), phase 3

Conditions: Substance Abuse

Summary: this is a 4-phase study to implement the nida cdes in primary care settings. collecting and utilizing the cdes in clinical practice requires a strategy for implementing screening to collect substance use information that populates the cdes, and assisting primary care medical staff to offer appropriate interventions by providing clinical decision support (cds) and a mechanism for making referrals to addiction treatment. investigators aim to maximize the efficient adoption of screening, cds, and treatment referrals by integrating all of these activities into the electronic health record (ehr). the study will be conducted at three sites, representing three large health systems. each phase will include deliverables essential to move to the next phase, and an independent advisory committee will review progress and make recommendations at each transition about how best to progress to each subsequent phase. based on progress during earlier phases, the advisory committee may recommend expansion to additional clinics or health systems during the second part of phase 4.

specific aims 1. to program the nida ctn cdes, the nida/asam electronic clinical quality measure (ecqm), and a lean decision support module into epic. 2. to study the process of implementation of screening and referral using epic-driven cdes and cds in three primary care clinics / practices, including defining potential barriers and facilitators to their adoption. 3. to evaluate the impact of implementation on: * patient level outcomes (diagnosis, treatment referral); * medical staff level outcomes (screening and assessment, clinical interventions including counseling and treatment referral); and * systems level outcomes (logistics and costs of introducing the cdes, feasibility).

Eligibility criteria:
inclusion criteria: * english speaking adult individuals age 18 years or older, and current employee or patient at a wave 1 clinic with direct patient contact. exclusion criteria: * inability to provide informed consent.
antithrombin-iii for patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation

Conditions: Hepatic Veno-Occlusive Disease

Summary: to evaluate efficacy and safety of at-iii treatment in patients with hepatic veno-occlusive diseases following hematopoietic stem cell transplantation.


Eligibility criteria:
inclusion criteria: 1. patients with hepatic veno-occlusive disease after hematopoietic stem cell transplantation. the following criteria will be used. 1. two of the following * serum total bilirubin \> 2.0 mg/dl * hepatomegaly or right upper quadrant pain of liver origin * unexplained weight gain of\>2% over baseline because of fluid accumulation 2. patients with pathologic diagnosis. 2. patients with informed consent exclusion criteria: 1. pregnant or nursing women. 2. malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. 3. psychiatric disorder that would preclude compliance. 4. patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study. 5. history of anaphylactic reaction to the study drug

Keywords: hepatic veno-occlusive disease after hematopoietic stem cell transplantation
docetaxel+oxaliplatin+s-1 (dos) regimen as neoadjuvant chemotherapy in advanced gastric cancer

Conditions: Gastric Cancer

Summary: primary objective: - to compare the 3-year progression free survival (pfs) in the two treatment arms. secondary objectives: * overall survival (os). * postoperative pathological stage and r0 (complete) resection rate. * safety: toxicities associated with neoadjuvant chemotherapy, surgery, morbidity/mortality, toxicity of adjuvant chemotherapy.

participants in the neoadjuvant chemotherapy arm were treated for 3 cycles (1 cycle is 21 days) before surgery and treated for a year with s-1. participants in the adjuvant chemotherapy arm underwent surgery and were treated for a year with s-1. all participants were followed during and after the study treatment until death or disease progression, whichever comes first.

Eligibility criteria:
inclusion criteria : * participants with new histologically confirmed, newly diagnosed, localized gastric or gastro-oesophageal adenocarcinoma, that is considered resectable. * participants with clinical stage (t2-3/n(+), t4/n(+/-):n positive means greater than or equal to \[\>=\] 8 in hour axis). * signed informed consent. exclusion criteria: * aged less than (\ = 76 years. performance status \>=2 in eastern cooperative oncology group (ecog) scale * the participants who had the history of other malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix which had been already successfully treated. * previous surgery on neoplasm of stomach. * participants who did not completely recovered from surgery. * distant metastases (m1) to other organs including distant nodal groups (retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node). severe/unstable angina, coronary artery bypass graft, congestive heart failure, transient ischemic attack within 6 months prior to enrollment in the study. * any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy, for the currently treated gastric cancer. * participants with active infection or sepsis. * intolerance of oral taking or malabsorption: lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of s-1. ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug resorption. this includes gastric dumping syndrome, indications of accelerated passage through the small intestine and indications of resorption disorders after intestinal surgery. * greater than or equal to grade 2 severe tumour haemorrhage. * simultaneous participation in another study, or participation in another study within 4 weeks of commencement of this study. * pregnant or lactating participants. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
comparison between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft

Conditions: Unstable Angina; Coronary Artery Bypass Graft; Dexmedetomidine; Lidocaine; Myocardial Injury; Arrhythmia; Blood Electrolyte Balance

Summary: the aim of the present study is to compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.

lidocaine has been reported to have an antiarrhythmic and myocardial protective effect. a previous study has reported that low-dose lidocaine infusion can decrease the incidence of ventricular fibrillation and tachycardia during the first 24 hours after coronary artery bypass graft (cabg). a recent study also reported that the lidocaine infusion during cabg could decrease the myocardial injury by measuring the ck-mb and troponin-i blood level. dexmedetomidine is an alpha-2 agonist and reduces the sympathetic tone and neuroendocrine stress response. dexmedetomidine was reported to have a cardioprotective effect by a previous animal study. however, there was no clinical study evaluating the cardioprotective effect of dexmedetomidine. therefore, we are trying to evaluate and compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.

Eligibility criteria:
inclusion criteria: * those undergoing off-pump coronary artery bypass graft during the study period in samsung medical center exclusion criteria: * any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, cushing syndrome * patients with recent exogenous steroid administration or previous diuretics therapy * patients with recent myocardial infarction * those undergoing unplanned cardiopulmonary bypass during the surgery

Keywords: coronary artery bypass graft dexmedetomidine lidocaine myocardial injury arrhythmia blood electrolyte balance
clinical status and bronchial inflammation in patients with bronchiolitis obliterans

Conditions: Bronchiolitis Obliterans

Summary: the aim of this case-control study is the characterization of the bronchial and systemic inflammation of children and young adults with bronchiolitis obliterans. on the first visit subjects are asked to perform a lung function test (spirometry, body plethysmography with helium). further levels of eno and eco are determined. a blood sample is drawn to describe the inflammatory status. bronchial inflammation will be measured in induced sputum. at the second visit, a non-specific bronchial provocation testing (pd20 fev1 methacholine) is performed.

objectives: the aim of this study is the characterization of patients with bronchiolitis obliterans in terms of lung function, bronchial hyperreactivity and the degree of the systemic and bronchial inflammation. sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (pcr) (qrt-pcr) and by cytometric bead assay (cba). components of the innate immune system (mannose-binding protein, tlr recognition proteins and surfactant proteins) are genetically determined from sputum or blood respectively. in the conduct of this study the investigators will retrospectively and systematically evaluate the available high-resolution computed tomography (hrct) studies of affected patients methods and work programme: this study consists of two study visits (v1 and v2) v1: * measurement of nitric oxide in expired air (eno) * measurement of carbon monoxide in the exhaled air (eco) * lung function testing with spirometry and body plethysmography * blood test: blood count, crp, rast, serum inflammatory mediators, genetic markers of the non-specific pulmonary defense system * induced sputum for inflammatory mediators and microbiological investigations v2: • unspecific bronchial provocation test with methacholine (pd20 fev1 methacholine) study population: children and young people (6 - 25 years of age). both the patients and the healthy subjects are recruited from the outpatient clinic of pediatric allergy and pulmonology.

Eligibility criteria:
inclusion criteria: * informed consent * between 6 and 25 years of age * known bronchiolitis obliterans / no bronchiolitis obliterans(depending on the study group) * ability to perform lung function tests and inhalation exclusion criteria: * \ 25 years of age on the day of written informed consent * acute illness with systemic or bronchial inflammation * every chronic condition or infection (eg hiv, tuberculosis, malignancy) * pregnancy * known alcohol and/ or drug abuse * inability to understand the extent and scope of the study * participation in another study

Keywords: bronchiolitis obliterans hrct sputum blood inflammation adaptive immune system innate immune system
laser tongue debridement for oral malodor

Conditions: Halitosis

Summary: malodor is a multifactorial condition with oral pathology representing the main culprit and the tongue being the first to second contributor to the malodor. bacterial load can represent a quantifiable measure regardless of the original pathology. it is hypothesized that reduction in malodor can be represented by tongue changes both in appearance, bacterial and biofilm load reduction (measured by cfu and volatile gases measurement), organoleptic measurement and subjective improvement. methods: a randomized controlled prospective study under irb approval. diagnostic criteria for enrollment and follow up were organoleptic test by 2 judges, halimeter reading, tongue colores changes halt questionnaire and direct aerobic and anaerobic tongue cultures measured by cfu. patients were treated with laser tongue debridement (ltd) with an er,cr:ysgg solid state laser has been shown to be effective in biofilm reduction.


Eligibility criteria:
inclusion criteria: * an individual (male or female) who can understand and voluntarily sign an informed consent form * a baseline organoleptic oral malodor score of at least 2 exclusion criteria: * severe caries, * signs of gingival inflammation on intraoral exam * possible extra-oral halitosis (tonsillitis, sinusitis, and pulmonary pathologic conditions, or a condition that may contribute to systemic halitosis, such as hepatic cirrhosis or uncontrolled diabetes) * antibiotic treatment within 1 month prior to study * pregnant
formula for children with cow's milk allergy

Conditions: Milk Allergy

Summary: the purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with cow's milk allergy.


Eligibility criteria:
inclusion criteria: * good health * parent/guardian must be willing to provide informed consent * parent/guardian agrees to feed study formula provided * confirmation of cow's milk allergy exclusion criteria: * no clinically significant abnormal findings on medical history, laboratory results, and physical exam. * no medications that may interfere with or impact evaluation of the study assessments * allergy to extensively hydrolyzed casein formula * tolerance of 200 ml of cow's milk, cow's milk-based formula or food products containing intact cow's milk protein within 2 weeks of the screening visit * participation in another clinical trial within 30 days of screening where they are are receiving an active intervention
pilates physical activity in sickle cell disease

Conditions: Sickle Cell Disease

Summary: sickle cell anemia (sca) is a life-threatening hereditary hemoglobinopathy characterized by hemoglobin (hb) polymerization that affects many people worldwide.reduced physical capacity is common in people with sca. pilates is a form of physical activity that recently used in clinicial practice

sca patients (40 patients) with ages more than 18 years will join randomly the pilates group (20 patients) or control non exercised group (20 patients). pilates will be trained 30 minutes (before it there will be warm up period and after it there will be cooldown period , each will be 5 minutes). the pilates will be repeated five sessions per the week for 3 months

Eligibility criteria:
inclusion criteria: * sedentary sickle disease patients from both both sexes in medical stable condition exclusion criteria: * cardiac complaints, pregnant women, patients who smoke or drink alchols
a clinical investigation of arcomxl® polyethylene in total hip replacement

Conditions: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis

Summary: the purpose of this data collection is to determine long term survival rate of arcomxl® highly cross-linked polyethylene

approximately 500 patients (cases) will be enrolled in this data collection effort and 10-year follow-up will be attempted. follow-up will be obtained by sending a questionnaire directly to the patients by mail. the follow-up will be annually and only survivorship data will be collected. this data collection project was developed in order to determine the actual long-term (10-year) survival rate of biomet's arcom xl highly cross-linked polyethylene. data will be collated for uncemented cases only. this will eliminate the possibility of cement or cement debris being a confounding variable. the data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Eligibility criteria:
inclusion criteria: * non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * rheumatoid arthritis * correction of functional deformity * treatment of non-union, femoral neck fractures, trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * revision of previously failed total hip arthroplasty * uncemented applications exclusion criteria: absolute contraindications * infection, sepsis and osteomyelitis relative contraindications * uncooperative patient or patient with neurologic disorders who are incapable of following directions * osteoporosis * metabolic disorders which may impair bone formation * osteomalacia * distant foci of infections which may be spread to the implant site * rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy or neuromuscular disease

Keywords: total hip arthroplasty total hip replacement hip arthritis polyethylene
assessment of safety & efficacy of light weight breast implant

Conditions: Breast Implants

Summary: the purpose of this study is to evaluate safety and effectiveness of light weight breast implant (lwbi) in breast augmentation.

this is a single-center. the purpose of the study is to evaluate safety and effectiveness of lwbi in breast augmentation.

Eligibility criteria:
inclusion criteria: * genetic women at ages 18 to 65 seeking breast enlargement * signed informed consent * agreement to complete all required follow up visits * a medically acceptable candidate * sufficient breast tissue for proper implant coverage (≥20 mm by pinch test) exclusion criteria: * patients with active infection anywhere in their body * women who are currently pregnant or nursing * insufficient tissue covering in the prospective area of implantation (e.g. after preceding breast reduction), radiation damage or reduced vascularization * abscesses, malignant tumors(cancer or recurrent metastases), advanced fibrocystic diseases * patients with a history of psychiatric treatment * patients that been implanted with any silicone implant (e.g. silicone artificial joints, facial implants) * expected allergies or extraordinary immune response to implants * wound healing impairments or heavy burn scars * existing costal injuries * the patient participated in an investigational trial within 30 days of enrollment
efficacy and safety of four doses of glycopyrronium bromide (nva237) in patients with stable chronic obstructive pulmonary disease (copd), in comparison to an active comparator tiotropium

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study will assess the efficacy and safety of glycopyrronium bromide (nva237) in patients with stable copd, in comparison to an active comparator.


Eligibility criteria:
inclusion criteria: * male or female adults aged ≥40 years, who have signed an informed consent form prior to initiation of any study-related procedure. * patients with moderate to severe copd according to the gold guidelines (2006). * patients who have smoking history of at least 10 pack years. ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc. * patients with a post-bronchodilator forced expiratory volume in 1 second (fev1) ≥30% and \< 80% of the predicted normal, and post-bronchodilator fev1/forced vital capacity (fvc) \< 0.7 at visit 2. for non-japanese patients predicted fev1 should be calculated according to quanjer predictive equations \[quanjer ph 1993\], for japanese patients predicted fev1 should be calculated according to japanese respiratory society predictive tables \[japan respiratory society 2001\]. exclusion criteria: * pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test). * patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to visit 1 or between visit 1 and visit 3. * patients who have had a respiratory tract infection within 6 weeks prior to visit 1. patients who develop a respiratory tract infection during the screening period (up to visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection). * patients who, in the judgment of the investigator or the responsible novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrow angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment. * patients with a history of asthma indicated by (but not limited to): 1. blood eosinophil count \> 400/mm3 2. onset of symptoms prior to age 40 years. other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd, age≥40 yrs, glycopyrronium bromide
post covid-19 infection central sensitisation

Conditions: Covid19

Summary: the aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection.

the covid-19 pandemic is currently a serious global public health concern. this disease is caused by a novel coronavirus which was first discovered in wuhan, china in 2019 and later spread rapidly throughout the world. symptoms of the disease can manifest as fever, cough, encephalitis, myalgia, fatigue, muscle weakness, arthralgia, anosmia, and impairment in other bodily functions in the acute phase. in 17% to 67% of cases, covid-19 patients will develop acute respiratory distress syndrome (ards) and critical illness. besides the impact on the respiratory system, coronaviruses have an effect on other systems including the central nervous system, cardiovascular system, musculoskeletal system, and gastrointestinal system. the term central sensitivity syndrome (css) describes a group of medically nonspecific disorders, such as fibromyalgia, chronic fatigue syndrome, and irritable bowel syndrome, for which central sensitivity might be a common etiology. despite the lack of a solid outcome measurement, the central sensitization inventory (csi) was previously introduced as a screening instrument for clinicians to help identify patients with a css. furthermore, quantitative sensory testing can be used to identify and quantify sensory disfunctions by evaluating a variety of parameters including pain thresholds, temporal summation, and conditioned pain modulation (cpm). previous research in patients with chronic pain resulted in less efficacious cpm, increased nociceptive facilitation and decreased pain thresholds. in post covid-19 patients, potential long-term secondary effects on the musculoskeletal system such as muscle weakness, decreased muscle mass, and myopathies have been brought under attention. persisting symptoms are a frequently reported complaint in patients recovered from covid-19 infection with at least 1 symptom, particularly fatigue and dyspnea. fatigue is also one of the core symptoms in central sensitisation disorders, leading to the hypothesis that central sensitisation might be the underlying common etiology in chronic pain patients and patients post covid-19 infection. therefore, the aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection.

Eligibility criteria:
inclusion criteria: * patients with a diagnosed covid-19 infection that took place at least 6 months before study inclusion. * cognitive and language functioning enabling coherent communication between the researcher and the participant. * french-or dutch speaking persons. exclusion criteria: * covid-19 infection \< 6 months ago.