Kornimate/medical-research-clean huggingface dataset:
incidence and risk factors for developing infections in patients colonized by cp-kpc

Conditions: Carbapenemase-Producing Enterobacteriaceae

Summary: the worldwide increase in the rate of infections due to multidrug-resistant bacteria is considered a major public health problem. infections caused by carbapenem-resistant klebsiella pneumoniae (cr-kp) are associated with high morbidity and mortality. mortality of up to 70% and, in survivors, a readmission rate of up to 72% within 90 days of discharge have been reported. cr-kp infection is usually preceded by colonization. however, the incidence rate and risk factors for cr-kp infections among carriers is poorly understood. multiple studies have focused in risk factors to develop infections among carriers. in order to identify patients at low risk of cr-kp bloodstream infections, gianella et at developed a predictive score to stratify patients according to their risk for acquisition of cr-kp infections. however, further studies are needed to validate these results, particularly in high-risk patients, such as haematological patients, solid organ trasplant recipients and patients admitted in icu. italian hospital is an acute tertiary care university teaching hospital with more than 45,000 admission-years, in buenos aires, argentina, with a great proportion of haematological and solid organ transplant recipients, and patients with substantial comorbidities and immunosuppression. with the aim of developing an adequate risk assessment for cr-kp infections among cr-kp carriers, we performed a retrospective cohort analysis, in a tertiary teaching hospital in buenos aires, argentina. the main purpose of our study is to describe the incidence of cr-kp infections among crkp colonized patients, to demonstrate the risk factors for acquisition of cr-kp infections and to develop a clinical predictive score that could stratify patients to guide therapeutic decisions in cr-kp carriers, and avoid overuse of broad-spectrum therapy.


Eligibility criteria:
inclusion criteria: * adult (≥18 years) patients with a cr-kp positive rectal swab, hospitalized from 01/2014 to 01/2019 exclusion criteria: * unwillingness to participate

Keywords: health care associated infections; carbapenemase-producing enterobacteriaceae; colonization status risk factors
a u.s post approval study evaluating the synergy xlv (megatron) stent system

Conditions: Atherosclerosis; Heart Diseases, Coronary; Coronary Artery Disease; Cardiovascular Diseases

Summary: this is a post-market, standard of care, real-world observational study to assess the clinical outcomes of the synergy xlv (megatron) coronary stent system for the treatment of subjects with atherosclerotic lesion(s) ≤ 28 mm in length (by visual estimate) in native coronary arteries ≥3.50 mm to ≤5.00 mm in diameter (by visual estimate). this post approval study is a cohort associated with the evolve 4.5/5.0 (synergy lv) post approval study, which is registered under clinicaltrials.gov id: nct03875651.


Eligibility criteria:
inclusion criteria: * patient requires treatment with a synergy xlv (megatron) stent exclusion criteria: * planned treatment with a non-synergy stent

Keywords: drug-eluting stents
a 52-week parallel group safety study of td-4208 in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to measure the safety and tolerability of td 4208, an investigational drug being developed to treat people with moderate to very severe copd, compared to tiotropium.


Eligibility criteria:
inclusion criteria: * subject is a male or female subject 40 years of age or older exclusion criteria: * females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Keywords: chronic obstructive pulmonary disease, copd
carvedilol, endoscopic variceal ligation or combination of both for prevention of first variceal bleed in child's b & c cirrhosis

Conditions: Cirrhosis

Summary: study design: open labeled randomized controlled trial. the study will be conducted on patients attending outpatient or admitted to admitted to department of hepatology from january 2017 to december 2018 at ilbs, new delhi


Eligibility criteria:
inclusion criteria: * liver cirrhotics between 18-70 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan \& imaging.) * ctp ≥ 7-15 (child's b/c) * small esophageal varices with rcs and large esophageal varices (\>5 mm) * no history of previous bleed exclusion criteria: * malignancy-hcc, pvt * child a * meld \>35 * contraindications to β blockers. * platelet count \< 30,000/mm3 * previous endoscopic variceal treatment. (beyond 21 days) * patients having an indication for tips or requiring more than 1 therapeutic ascitic tapping/month * post tips, shunt surgery * acute kidney injury (sr.cr\>1.5mg/dl) * non cirrhotic portal hypertension * acute on chronic liver failure
to evaluate the immunogenicity and safety of 'br-td-1001' administered intramuscularly in healthy children

Conditions: Diphtheria; Tetanus

Summary: the purpose of this study is to evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with br-td-1001 and td-pur-inj.

primary objective: to evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with br-td-1001 and td-pur-inj. secondary objectives: * to evaluate immunogenicity by measuring the geometric mean titer (of diphtheria and tetanus antitoxins at 28 days after vaccination with br-td-1001 and td-pur-inj. * to evaluate a boosting response by comparing before and after the administration through measurement of diphtheria and tetanus antitoxin titers at 28 days after vaccination with br-td-1001 and td-pur-inj. * to evaluate safety by observing solicited local and systemic adverse events that have occurred for 7 days after vaccination with br-td-1001 and td-pur-inj. * to evaluate safety by observing unsolicited adverse events that have occurred for 28 days after vaccination with br-td-1001 and td-pur-inj.

Eligibility criteria:
inclusion criteria: 1. healthy boys and girls aged 10 to 12 years 2. those who received primary immunization (5 doses of diphtheria and tetanus vaccination until the age of 6) 3. voluntary written consent of the subject and the legally acceptable representative(lar) to participate in this clinical study exclusion criteria: 1. 2 weeks have not passed since recovery from an acute disease 2. temporary thrombocytopenia or neurological complications due to diphtheria or tetanus vaccination 3. history of a severe allergy to any component of the investigational product 4. history of a severe adverse event due to administration of diphtheria, tetanus, or diphtheria tetanus combined vaccine 5. administration of tetanus, diphtheria, or diphtheria tetanus combined vaccine within 5 years 6. unable to verify diphtheria and tetanus vaccination completed until the age of 6 7. history of infection with diphtheria or tetanus (if clinically, serologically or microbiologically confirmed) 8. current chronic disease that impedes implementation or completion of the clinical study 9. scheduled surgery during the study period 10. acute fever with a tympanic temperature exceeding 38.0ºc within 72 hours before administration of the investigational vaccine 11. administration of other vaccines within 28 days before screening 12. use of immunosuppressants or immune modifying drugs within 3 months before screening 13. those who have received immunoglobulin therapies or blood derived products within 3 months before screening, or are expected to receive them during the study period 14. use of antipyretics/analgesics/nonsteroidal anti inflammatory drugs within 4 hours before administration of the investigational vaccine 15. participation in other clinical studies within 28 days before screening 16. those who were determined by the investigator to be ineligible for other reasons

Keywords: diphtheria tetanus
neoadjuvant gefitinib followed by surgery and gefitinib in unresectable stage iii nsclc with egfr mutations.

Conditions: Lung Cancer

Summary: the purpose of this study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable stage iii nsclc harboring egfr mutations.

concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage iii non-small cell lung cancer (nsclc), although surgery offers the chance of cure. with combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage iii nsclc remains poor. gefitinib has shown great efficacy in nsclc patients with egfr mutations. this study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable egfr mutant stage iii nsclc.

Eligibility criteria:
inclusion criteria: * target population is unresectable stage iii (iii a-bulky n2, iii b) nsclc with egfr activating mutation in exon 19 or 21 * written informed consent provided * aged 18-75 years * able to comply with the required protocol and follow-up procedures * eastern cooperative oncology group (ecog) performance status of 0-1 * had a life expectancy of 12 weeks or more * adequate hematological function, liver function and renal function * female participants should not be pregnant or breast-feeding exclusion criteria: * known severe hypersensitivity to gefitinib or any of the excipients of this product * inability to comply with protocol or study procedures * had had previous chemotherapy, radiotherapy, or agents directed at the her axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab) * had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder * interstitial pneumonia * eye inflammation not fully controlled or conditions predisposing the subject to this * any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease) * known human immunodeficiency virus (hiv) infection * pregnancy or breast-feeding women * history of neurologic or psychiatric disorders * ingredients mixed with small cell lung cancer patients
comparison of regional anaesthesia methods for femoral neck fracture surgery

Conditions: Femoral Neck Fractures; Regional Anesthesia

Summary: femoral fracture surgery is frequently performed especially in geriatric population. compared to general anaesthesia, regional anaesthesia is preferred to general anaesthesia in the geriatric patient population due to lower postoperative pulmonary complications, reduced frequency of delirium and analgesic requirement, intraoperative haemodynamic stability, early postoperative mobilisation and early discharge. central and peripheral regional anaesthesia methods have advantages and disadvantages. this situation causes difficulties in the choice of anaesthesia method. central regional anaesthesia techniques have more haemodynamic effects and higher frequency of complications compared to peripheral methods. the disadvantages of peripheral methods are that they require ultrasound, block needle, nerve stimulator and require knowledgeable and skilled practitioners. since there is no study showing the comparison of peripheral nerve blocks and hypobaric spinal anaesthesia with objective nociception values and there are difficulties in the choice of anaesthesia method in this regard, a study was deemed necessary.


Eligibility criteria:
inclusion criteria: * \>18 years and \<90 years * asa (american society of anesthesiologists) score between i and iv * patients who will undergo femoral neck fracture surgery exclusion criteria: * previous local anesthetic allergy * those with bleeding diathesis disorder * having a mental disorder * those who are allergic to the drugs used * patients who did not consent to participate in the study * presence of infection in the block area * body mass index \>30 * preoperative or intraoperative general anesthesia * patients for whom consent cannot be obtained * pregnant patients
the statin choice decision aid for type 2 diabetes patients

Conditions: Diabetes

Summary: diabetes is a growing epidemic within the united states that disproportionately affects economically disadvantaged communities like east harlem. as diabetic patients are at very high risk for heart disease, experts recommend an aggressive approach towards using statins in people with diabetes. however, statins and other helpful drugs are only effective if patients decide to take them. adherence to this medication is notoriously poor and is aggravated by its required life-long use. this study is designed to test the effectiveness of a new decision aid in helping diverse, inner-city patients with diabetes understand the risks and benefits in taking statins and whether this enhanced decision making process improves their adherence to the medication.

to compare the efficacy of usual consultations with or without the decision aid statin choice in type 2 diabetic patients using or considering using statins to lower cv risk in terms of statin use, adherence, knowledge, beliefs and decisional conflict. the study team's primary hypothesis is that 3 months after the index discussion, significantly more patients randomized to statin choice are using statins, are adherent to statins, are knowledgeable about the statin choice, and are satisfied with their decision than patients randomized to usual care consultation, and that these benefits will be achieved without deterioration in quality of life.

Eligibility criteria:
inclusion criteria: eligible providers are * internists and nurse practitioners * provide care for patients with type 2 diabetes * do not plan to relocate outside the practice in the next 6 months. eligible patients * have a diagnosis of type 2 diabetes mellitus \> 1 month confirmed by provider or the medical chart * do not take statins, but their providers identify them as eligible for this medication * are currently taking statins exclusion criteria: ineligible patients * have, in the providers' judgment, major barriers such as hearing impairment or dementia that would compromise their participation in shared decisionmaking; * are not available for follow-up 3 months after randomization * are pregnant * are under age 21
mastiha or mastiha water in functional dyspepsia

Conditions: Functional Dyspepsia

Summary: the main aim of this study is to establish whether mastiha products ameliorate functional dyspepsia symptoms.

functional dyspepsia has an approximate prevalence of 20% and is one of the main causes of upper abdominal discomfort. its pathogenesis remain unclear and therapeutic options remain limited with patients seeking alternative therapies in herbal remedies. mastiha has been proven to significantly improve symptoms in patients with functional dyspepsia compared to placebo. in the present study, the investigators aim to determine whether mastiha capsules or mastiha water have a better effect on the improvement of functional dyspepsia symptoms. therefore, the investigators designed a randomized, three-way cross-over clinical trial. fifty patients with functional dyspepsia, will be randomized over three treatment sequences of 30 days each, separated by 14-day washout periods. the three treatments will be: mastiha capsules, mastiha water or mastiha free treatment. the primary outcome, which will be assessed by intention to treat, will be the leuven postprandial distress scale, a validated instrument for the assessment of symptoms in functional dyspepsia, supported by the european medicines agency.

Eligibility criteria:
inclusion criteria: functional dyspepsia diagnosis according to * rome criteria * negative urea breath test for helicobacter pylori * upper gastrointestinal tract endoscopy with biopsy exclusion criteria: * organic diseases, such as peptic ulcer, gastrointestinal neoplasms, gastroesophageal reflux, irritable bowel syndrome * pregnancy or lactation * history of abdominal surgery or actinotherapy * mental illness * severe impairment of heart, liver, or kidney function or respiratory function * alcohol overuse
validation study for disability assessment functional of patients with inflammatory diseases intestinal chronic (validate)

Conditions: Inflammatory Bowel Diseases

Summary: inflammatory bowel diseases (ibd) often affect psychological, family, social and professional dimensions of patients' life, leading to disability which is essential to quantify as part of patient-reported outcomes (pros) newly included in the therapeutic targets to reach in ibd patients. up to now, the ibd-disability index (ibd-di) was the only validated tool to assess functional status, but it is not appropriate for use in clinical practice. the ibd disk was then developed, a shortened and self-administered tool, adapted from the ibd-di, in order to give immediate representation of patient-reported disability. however, the ibd disk has not been validated yet in clinical practice. the aims of the validate study is to validate this tool in a large population of french ibd patients and to compare it to the already validated ibd-di.

the ibd-disk has not been evaluated in clinical practice and has not yet been validated. but the interest of rapid assessment of the disease led the physicians in university hospital of nantes' department, some of whom had participated in the construction of this tool, to use it in routine practice for consultations of patients with ibd, joined by many gastroenterologists from other hospitals including the university hospitals of rennes and angers. the objective of this study is to validate this tool and prove its effectiveness by comparing it to the gold standard represented by the ibd-di, in the same way that the psodisk has been validated prospectively compared to other tools for evaluating the quality of life and activity of psoriatic disease.

Eligibility criteria:
inclusion criteria: * patients of both sexes * aged over 18 with an established diagnosis of ibd (crohn's disease, ulcerative colitis or ibd unclassified) exclusion criteria: * ongoing pregnancy or breast feeding woman * vulnerable people i.e. adults under a legal protection regime (guardianship, trusteeship, judicial safeguard ) * insufficient command of french language and relevant psychiatric comorbidities (both of them making the self-questionnaire difficult to fill in) * uncertain ibd diagnosis

Keywords: inflammatory bowel diseases disability quality of life ibd disk ibd-disability index patient-reported outcomes
sarcopenia screening in elderly individuals

Conditions: Sarcopenia

Summary: in this study, it is aimed to evaluate parameters such as sarcopenia screening, muscle mass measurement, loss of strength that may develop due to sarcopenia, loss of balance and related fall, decrease in functionality, fragility and decreased physical activity in individuals aged 65 years and older in kırıkkale city center.

although aging occurs in all periods in the human body, physical, mental and physical aging becomes visible as you get older. this situation is caused by physiological aging, environmental factors, existing chronic diseases and related symptoms. today, increasing life expectancy and aging population must be taken into account. since the age-related symptoms of elderly individuals are compatible with the consequences of aging, they can be ignored as a natural process, and therefore its progression cannot be prevented. with our project, it is aimed that screening for sarcopenia will be an exemplary study throughout turkey and this type of screening will be widespread. in addition, it is aimed to divide elderly individuals into groups as presarcopenia, sarcopenia and severe sarcopenia, and to provide necessary guidance, protective and prevention approaches, strengthening and exercise training. demographic data of elderly individuals (age, gender, height, weight, bmi (body mass index will be obtained by dividing body weight (kg), height (m) squared) occupation, etc.), chronic diseases (hypertension, diabetes, chronic obstructive pulmonary disease) (copd), rheumatic diseases), drugs used, smoking, alcohol habits, and assistive device use, and the 'clinical vulnerability scale' to evaluate the cognitive status of individuals through the 'mini nutritional assessment form (mna)'. 'standardized mini-mental test' to assess balance and walking, 'tinetti balance and walking test' to evaluate balance and walking, 'falling risk self-assessment scale' to assess falls, 'functional independence and challenge scale' to measure functional independence in activities of daily living. 'short physical performance test' (kfpt), sarcopenia screening test (sa) to assess physical fitness rc-f), it is planned to use the physical activity scale for the elderly (pase) to evaluate the level of physical activity, to use hand dynamometer, to evaluate muscle strength, and to measure the muscle mass of individuals with an inbody bioimpedance device.

Eligibility criteria:
inclusion criteria: * individuals aged 65 and over * their willingness to participate in the study * a score of 24 or higher on the mini mental state test (mmdt) exclusion criteria: * individuals under the age of 65 * individuals who cannot communicate well * elderly individuals who cannot walk independently, have any orthopedic or neurological problems * individuals who do not want to participate in the study * individuals not eligible for bioimpedance analysis (pregnant individuals with pacemakers).

Keywords: rehabilitation physical inactivity fragility
the effect of a vapor barrier in combination with active external rewarming for patients with accidental hypothermia

Conditions: Hypothermia, Accidental

Summary: most guidelines recommend the use of a vapor barrier when wrapping and isolating hypothermic patients from the environment, and this is especially important if the patient is wearing wet clothing. the vapor barrier will contain moisture evaporated from the wet clothes of the patient and increase the humidity. once the humidity levels reach 100%, the evaporation and thereby the evaporative heat loss will stop. the theory is that the addition of a vapor barrier will reduce the amount of heat loss and contribute to more efficient rewarming of wet, hypothermic patients. we aim to investigate how much more efficient a wrapping model with active external rewarming is with the addition of a vapor barrier.

the study will use a crossover design on where research participants will undergo repetitions of the same scenario with different interventions in order to serve as their own control. the research participants will be healthy volunteers providing both oral and written consent. we intend to perform the experiments in an outdoor laboratory in order to achieve the most realistic conditions possible. the experiments will be conducted in hemsedal, norway in our "mountain lab", a climate chamber built inside a snow cave. before the start of the experiment, the research participants will be positioned in a supine position in the snow cave on an insulated stretcher in wet clothes saturated with a standardized amount of water.

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * any cronic sickness