Kornimate/medical-research-clean huggingface dataset:
improving pneumococcal vaccination rates in an ambulatory pre-surgical testing setting

Conditions: Community Acquired Pneumonia

Summary: the purpose of this quality improvement project is to improve the immunization rates of an at-risk adult population seen in an ambulatory healthcare environment, through the use of targeted health education messages regarding pneumococcal immunization. patients seen in an out-patient pre-surgical testing center will receive 1) a one-page written information sheet that outlines the benefits of pneumococcal immunization and 2) verbal reinforcement of this message, provided by the clinical staff, during the patient's interview. at-risk adult patients (as defined by centers for disease control) seen in an ambulatory healthcare environment (a pre-surgical testing center) will receive a one page, "gain-framed" message that emphasizes the benefits of pneumococcal vaccinations. this educational material will be reviewed and reinforced by clinical staff during the assessment phase of the clinical visit. among this group, there will be increased vaccination rate compared with at-risk adult patients who did not receive this communication (prospective vs retrospective data).

the purpose of this project was to improve the immunization rates of an at-risk adult population seen in an ambulatory environment, through the use of targeted and evidence-based health education messages regarding pneumococcal immunization and staff training on the use of gain-framed messaging. we hypothesized that there would be an increase in immunization rates for at-risk adults following implementation of the intervention. the objective of the project was to increase our local immunization rate by 30% (from 20% to 50%) and to provide tools and processes that can be utilized in other ambulatory healthcare settings.

Eligibility criteria:
inclusion criteria: * patient seen in out-patient pre-surgical testing center * at-risk adult patient as defined by the centers for disease control (cdc) exclusion criteria: * minors

Keywords: pneumococcal vaccination rates, ambulatory settings
skin tolerance study of betamethasone creams in atopic eczema and the preventative properties of a moisturiser

Conditions: Atopic Eczema

Summary: topical steroid creams as well as moisturizing creams are important parts of the treatment strategy of atopic eczema. this study aims to investigate the tolerance of a new strong steroid cream in comparison to an already marketed reference cream with equal amount of active but with different cream vehicle. the second part of the study will investigate the possible preventative property of a moisturizing cream on skin that has been previously cleared from eczema.


Eligibility criteria:
inclusion criteria: * females and males between 18 and 65 years of age * caucasian * ad according to the criteria of hanifin and rajka (12) with eczematous lesions corresponding to an atopic dermatitis severity index (adsi) (13) score of at least 6 on any of the following areas: arms, legs, chest, abdomen or back * no serious health conditions that may interfere with the study * written informed consent exclusion criteria: * eczematous regions exclusively in intertriginous areas or in the face * use of topical steroids or any other dermatologic drug therapy (moisturising creams allowed) in the study area or light therapy within the preceding 2 weeks * use of oral steroids within 1 month prior to the study * use of concurrent medication e.g. medication that may interfere with the study related activities * factors suggesting low compliance with study procedures * possible allergy to ingredients in the study medications * pregnancy or breast feeding

Keywords: atopic eczema topical corticosteroid
effect of physical training program on health-related quality of life in cirrhosis

Conditions: Cirrhosis

Summary: physical training improves quality of life (qol) in non-hepatic diseases. it is possible that the same effect happens in patients with cirrhosis and portal hypertension. hepatic encephalopathy may also benefit from physical activity by increasing ammonia metabolism. the intention of this study is to assess if patients can improve their qol and hepatic encephalopathy during a physical training program, and to address its safety.

patients with cirrhosis and portal hypertension experience a marked deterioration in health-related quality of life (qol), as it has been shown with the use of questionnaires such as short-form-36 (sf-36) and chronic liver disease questionnaire (cldq). the deterioration in qol is progressively accentuated as liver failure advances. there is a positive association between the level of physical activity and the sense of qol, and physical training programs have proved to be useful in improving qol in cardiovascular and pulmonary diseases, and in conditions affecting cognition. thereby, it is hypothesized that a physical training program may improve qol and hepatic encephalopathy in patients with cirrhosis and portal hypertension. data supporting physical activity as a way to improve hepatic encephalopathy derives from experimental models showing that skeletal muscle is able to remove blood ammonia, presumably by inducing the enzyme glutamine synthetase. however, it is uncertain whether such a program is safe, or if it can lead to an increase in portal hypertension and progression of the disease.

Eligibility criteria:
inclusion criteria: * biopsy-proven or clinically evident cirrhosis * able to perform exercise exclusion criteria: * overt hepatic encephalopathy grades 3 or 4 * cardiovascular complications (pulmonary hypertension, heart failure) * diabetes mellitus and microangiopathic complications, or under treatment with insulin * renal failure * portal hypertension with high risk for variceal bleeding * hepatocellular carcinoma
identifying high- and low-risk heart failure patients in the emergency department (the stratify study)

Conditions: Cardiovascular Diseases

Summary: people with heart failure (hf) symptoms who are seen in the emergency department (ed) are often admitted to the hospital even though it may not be necessary. this study will gather information from hf patients seen in the ed to develop a decision-making tool that will help doctors predict the risk of hf-related death or serious complications. improving the ability of ed doctors to effectively and safely manage low-risk hf patients should lead to fewer unnecessary hospitalizations.

hf is a life-threatening condition in which the heart can no longer pump enough blood to the rest of the body. symptoms of hf can include shortness of breath, nausea, fatigue, swelling of the feet or abdomen, and an irregular or rapid pulse. a critical challenge facing ed doctors is how to best manage people who come into the ed with symptoms of hf. currently, most people evaluated for hf in the ed are admitted to the hospital; however, not all of these people are in need of such intensive treatment. it is estimated that up to 50% of hf-related hospital admissions could be avoided. improving the ability of the ed doctor to effectively and safely manage low-risk hf patients is essential to avoid unnecessary hospitalizations. this study will gather information from ed patients at risk for hf to develop an algorithm decision tool that will predict patients' risk for inpatient or outpatient death and serious complications from hf. this decision tool will be distributed worldwide for ed use and will hopefully reduce the costs of hf care by appropriately allocating hospital resources. this study will enroll adults admitted to the ed with possible signs of hf. while in the ed, participants will undergo a digital heart sound recording procedure, a medical record review, blood collection, and a brief cognitive assessment. five and 30 days following the ed visit, participants will be contacted by phone or will be visited in the hospital by study staff. information will be collected on health status and unplanned hospital or ed visits that have occurred following the initial ed visit.

Eligibility criteria:
inclusion criteria: * admitted to the adult ed with difficulty breathing, peripheral edema, or fatigue * meets framingham criteria for congestive heart failure * willing and able to give informed consent; this will be determined based on participants' ability to remain in a conscious state, ability to remain awake, ability to ask questions about the study or answer questions that are asked, and ability to date and sign a consent form.

Keywords: heart failure
evaluate the beneficial effects of an oral nutritional supplement based on leonurus cardiaca for the improvement of mood and anxiety

Conditions: General Anxiety Disorder

Summary: this study aims to evaluate the efficacy and safety of leonurus cardiaca extract in reducing anxiety symptoms in adults with generalized anxiety disorder (gad). sixty drug-free participants aged 20-50 years with a diagnosis of gad will be randomly assigned to receive either leonurus cardiaca extract or placebo for 30 days. the primary outcome is the reduction in anxiety symptoms assessed by the scag scale. secondary outcomes include changes in quality of life (sf-12), perceived stress (psq), anxiety severity (ham-a), and anthropometric measures. safety will be assessed through liver, kidney, and thyroid function tests. assessments will be conducted at baseline, day 14, and day 30.


Eligibility criteria:
inclusion criteria: * female participants aged 18 to 50 years * diagnosis of premenstrual syndrome (pms) or premenstrual dysphoric disorder (pmdd) according to dsm-5 criteria * regular menstrual cycles (25-35 days) in the past 6 months * presence of pms symptoms for at least 6 months, confirmed through prospective symptom diary * no hormonal treatment in the previous 3 months * written informed consent obtained exclusion criteria: * postmenopausal women, or those who are pregnant or breastfeeding * use of hormonal contraceptives in the last 3 months * current diagnosis of major psychiatric disorders (e.g., major depressive disorder, severe anxiety disorders, schizophrenia, bipolar disorder) * known endocrine disorders (e.g., hypothyroidism, hyperthyroidism, diabetes) * use of medications that could affect mood or the menstrual cycle (e.g., ssris, anxiolytics, antipsychotics) * severe hepatic or renal impairment * any other serious or unstable medical condition that, in the investigator's judgment, could interfere with study participation

Keywords: leonurus cardiaca herbal extract anxiety scag scale herbal remedy for gad ham-a psq sf-12
role of tibial nerve stimulation for enhanced postoperative recovery after colorectal surgery

Conditions: Postoperative Ileus; Colorectal Cancer

Summary: aim of the study is to evaluate the role of postoperative tibial nerve stimulation in the enhancement of the recovery of bowel function and in shortening the hospital stay.

patients were randomized in two groups. the first group underwent a three days postoperative transcutaneous tibial nerve stimulation. the second group underwent a sham stimulation. aim of the study is to evaluate the role of tibial nerve stimulation in the postoperative recovery after colorectal surgery.

Eligibility criteria:
inclusion criteria: * patients that underwent colorectal surgery exclusion criteria: * severe comorbidities * postoperative or intraoperative complications
efficacy and safety of lumiracoxib in patients with knee osteoarthritis (oa).

Conditions: Osteoarthritis, Knee

Summary: this study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (oa).


Eligibility criteria:
inclusion criteria: * primary osteoarthritis of knee (confirmed by american college of rheumatology \[acr\] criteria). * requirement of regular non-steroidal anti-inflammatory drug (nsaid) therapy. exclusion criteria: * evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years. * known hypersensitivity to analgesics, antipyretics, or nsaids (including celecoxib). other protocol-defined inclusion/exclusion criteria may apply.

Keywords: osteoarthritis, lumiracoxib, celecoxib, cox-2
a study of human rhinovirus type 16 (hrv-16) following administration in the nose of healthy adult volunteers

Conditions: Healthy

Summary: the purpose of this study is to evaluate the safety and clinical characteristics of a quantity of human rhinovirus type 16 (hrv-16) in healthy volunteers. this source of hrv-16 will be subsequently used in viral challenge studies with new compounds that are intended to treat respiratory diseases.

this is an open-label study in which all participants know the investigational substance being tested. participants will be inoculated in the nose with hrv-16 and evaluated for the occurrence of cold symptoms and other indicators. there will be 3 phases: a screening phase, an hrv-16 infection phase, and a follow-up phase. the dose of virus being tested in this study has been previously used in other challenge studies. the total length of participation in the study will be about 4 weeks. participant safety will be monitored.

Eligibility criteria:
inclusion criteria: * demonstrate an understanding of the study and sign an informed consent form prior to any study-related procedures * healthy with no clinically significant abnormalities as determined by medical history * women must be neither pregnant nor lactating (producing breast milk) and have a negative urine pregnancy test at screening visit 1 * women of child-bearing potential and all men must agree to use adequate birth control measures (as determined by the investigator) and must agree to continue to use such measures and not plan a pregnancy until after the day 6 visit * men must agree not to donate sperm during the study through the day 6 visit exclusion criteria: * have a documented serum-neutralizing antibody titer of \> 2-fold dilution to hrv-16 in the blood sample within approximately 40 days of screening visit 2 * live with a family member who cares for the elderly, infants, or small children (eg, nursing home or day care provider), or live with someone who has a chronic lung disease, premature infant, or immunocompromised individual * require a prescription or over-the-counter medication on a regular basis (3 or more times per week), except contraceptive preparations, hormone replacement therapy, or topical acne medication * have a history of chronic disease that the investigator believes are clinically significant * have a history of chronic headaches (eg frequent migraines, cluster headaches) with 3 or more headaches per week

Keywords: healthy volunteer rhinovirus cold virus hrv-16
drusen morphology changes in nonexudative age-related degeneration after oral antioxidants supplementation

Conditions: Macular Degeneration

Summary: purpose: to determine drusen morphology (volume and area) changes in nonexudative age-related macular degeneration (amd) after one year of oral supplementation with areds-like formulation.

methods: patients with areds category 2 and 3 amd were prospectively enrolled in this study, and were randomized to receive daily oral supplementation with lutein (12mg) + zeaxanthin (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid \[dha\] 540mg + eicosapentaenoic acid \[epa\] 360mg) + vitamin c (40mg) + vitamin e (20mg) + zinc (16mg) + copper (2mg), or observation during one year. etdrs vision, biomicroscopy, intraocular pressure (iop), color fundus photography and automatic measurement of drusen with topcon 3d-oct 2000 (topcon, tokyo, japan) using the 6 x 6 mm 3d cube scan protocol, were performed in all patients, at baseline and 12 months after. automated delineation of macular drusen was modified by the investigators when evident segmentation errors occurred.

Eligibility criteria:
inclusion criteria: * areds category 2 and 3 amd exclusion criteria: * areds category 4 amd * other ophthalmological diseases * currently on antioxidant supplementation
concurrent induction chemoimmunotherapy with epirubicine, oxaliplatin, capecitabine and panitumumab in kras wild-type, resectable type ii gastric adenocarcinoma

Conditions: KRAS Wild Type; Resectable Type II Gastric Adenocarcinoma

Summary: this is an open label, multicenter, single-arm phase ii trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent pmab in patients with resectable, histologically proven gastric or esophageal cancer.


Eligibility criteria:
inclusion criteria: * untreated, histologically confirmed, kras wild type, resectable gastric or esophageal adenocarcinoma * t2-4 nx m0 disease * ecog performance status 0-1 * adequate hematological status * adequate renal function * adequate hepatic function * adequate metabolic function exclusion criteria: * pregnant or breast feeding women * previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix * arterial or venous thromboembolism within 6 months before enrollment * clinically significant cardiovascular disease within 1 year before enrollment * history of interstitial lung disease
pharmacokinetic properties of lorcaserin in subjects with renal impairment

Conditions: Renal Impairment

Summary: the purpose of this study is to evaluate the pk properties of lorcaserin in subjects with end stage renal disease (esrd) who require dialysis and will be studied under dialysis and non-dialysis conditions.


Eligibility criteria:
inclusion criteria: 1. males or females aged between 18 and 79 years (inclusive) 2. able to give signed informed consent 3. renal function will fall into one of the following categories (ideal body weight will be used for the calculation): * one-fifth of subjects will have normal renal function, defined as creatinine clearance \> 80 ml/min calculated using the cockroft-gault equation * one-fifth of subjects will have creatinine clearance 51-80 ml/min * one-fifth of subjects will have creatinine clearance 31-50 ml/min * one-fifth of subjects will have creatinine clearance 5-30 ml/min, but not require dialysis * one-fifth of subjects will have chronic end stage renal disease, require regularly scheduled hemodialysis, and be on a stable hemodialysis regimen for at least 3 months prior to dosing 4. subjects in the renally impaired groups will have stable renal disease as per investigator's assessment, with no clinically meaningful changes for 1 month prior to randomization. 5. subjects in all groups will have a bmi of 27-45 kg/m2. 6. considered to be in stable health in the opinion of the investigator. 7. eligible male and female subjects must agree not to participate in a conception process. exclusion criteria: 1. prior participation in any study of lorcaserin. 2. clinically significant new illness in the 1 month before screening 3. not suitable to participate in the study in the opinion of the investigator including an existing physical or mental condition that prevents compliance with the protocol 4. history of any of the following cardiovascular conditions: * myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ecg), cva, tia or rind within 3 months of screening * cardiac arrhythmia requiring initiation of a new medical or surgical treatment within 3 months of screening (pacemaker and/or defibrillator implanted \> 3 months prior to screening is acceptable) * unstable angina * history of pulmonary artery hypertension 5. positive result of hiv, hepatitis b or hepatitis c screens. 6. malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins) 7. use of ssri's, snri's, and other medications must meet washout period. 8. recent history (within 3 months prior to the screening visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening. 9. participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to dosing 10. unwilling, or whose partner is unwilling, to use an adequate means of contraception during and for 1 month following completion/withdrawal of the study
a trial investigating the pharmacokinetic properties of nn1218 in subjects with diabetes mellitus, type 1

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to investigate the pharmacokinetic (the rate at which the body eliminates the trial drug) and pharmacodynamic (the effect of the trial drug on the body) profiles of nn1218 in comparison with insulin aspart.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus for at least 12 months * treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (csii) for more than 12 months. * body mass index (bmi) between 18.0-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to trial start * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
use of shear wave elastography for intraoperative brain and glioma stiffness measurements

Conditions: Glioma; Recurrent Glioma

Summary: this study investigates the role of intraoperative shear wave elastography ultrasound (isweu) in identifying healthy brain and tumor tissue stiffness differences. this data may be used to guide tumor resection in future patients.

primary objective: i. determine the feasibility of utilizing isweu measurements intraoperatively and in the human brain to measure tissue stiffness. outline: this is an observational study. patients undergo shear wave elastography ultrasound over 10-15 minutes during their standard of care surgery on study.

Eligibility criteria:
inclusion criteria: * patients must be at least 18 years old. * patients must have planned surgery for resection of a newly diagnosed or recurrent glioma. * patients with tumors located in the brain cortex or superficial white matter in which introduction of the ultrasound probe is straightforward and does not pose a risk for intraoperative complications. * patients must have a karnofsky performance status ≥ 60%. * patient or legally authorized representative (lar) willing to provide written informed consent. exclusion criteria: * patients with deep-seated brain tumors in which introduction of the ultrasound probe poses an increased risk. * patients with a history of any brain infections. * patients with implanted devices. * patients with any other neurological/neurosurgical disease that could affect tissue stiffness. * patients with any other structural brain defect that could affect tissue stiffness.
preoperative biliary drainage for the lower malignant obstructive jaundice

Conditions: Postoperative Complications

Summary: patients with the lower malignant obstructive jaundice planned to do the pancreaticoduodenectomy, receiving preoperative biliary drainage or early surgery (without preoperative biliary drainage), both groups has the similar surgical morbidity, no statistics significance.

patients with the lower malignant obstructive jaundice divided into two groups:early surgery, preoperative biliary drainage + surgery.

Eligibility criteria:
inclusion criteria: * patients with the lower malignant obstructive jaundice * total bilirubin: 150-350 umol/l exclusion criteria: * age less than 18 * emergency operation * biliary tract stent placed * past history of operation on pancreas * intraoperative unresectable tumor with pancreaticoduodenectomy * unresectable tumor or potential resectable tumor with pancreaticoduodenectomy

Keywords: postoperative complications, mortality, length of stay, economics