Kornimate/medical-research-clean huggingface dataset:
covid-19 testing sample acquisition throughput and efficiency

Conditions: SARS-CoV Infection; Respiratory Viral Infection; Personal Protective Equipment; Covid19

Summary: this qi project seeks to evaluate the relative test sample acquisition throughput, personal protective equipment utilization, and relative operational costs of provider-administered covid-19 (sars-cov-2) nasal samples with and with the use of hepa-filtered, positive pressure isolation booths.

beginning in march 2020, the mgh began outpatient testing for covid-19 (sars-cov-2) utilizing a provider-administered nasal swab samples. this was administered with infection control protocols utilizing full ppe protection for health providers who would don and doff gowns and gloves with each sample acquisition. with an aim to decrease ppe usage and increase efficiency, personal protective booths with hepa-filtered air called "hexapods" were employed, after infection control approval, within the mgh system beginning on april 16, 2020. ambulatory care management at mgh systematically monitors testing completed and ppe usage on a weekly basis. managers in charge of personnel changes shared necessary team structures and median salaries for different personnel involved with sample acquisition. mgh materials management were able to report on costs related to consumable supplies used during testing. in this investigation, this routinely collected data and averaged timed sample collection observations were used to compare before and after the hexapod utilization.

Eligibility criteria:
inclusion criteria: * all testing performed at designated outpatient sars-cov-2 at massachusetts general hospital (mgh) testing sites beginning march 2019. exclusion criteria: * sars-cov-2 tests performed not performed within designated outpatient testing sites at mgh. * testing performed within the hospital for emergency department or inpatient visits.

Keywords: sars-cov infection test sample acquisition personal protective equipment personal protective booths covid19
customized orthosis for children with clubfoot

Conditions: Congenital Talipes Equinovarus

Summary: this study will examine the use of a novel customized ankle foot orthosis (afo), created using 3d scanning, with children being treated for clubfoot. the afo is inserted in the standard mitchell shoe during bracing, following ponseti casting. the investigators hypothesize that following ponseti casting, the implementation of customized afos with ponseti bracing will improve patient compliance and functional outcomes as well as lead to fewer relapses in comparison to the standard bracing with mitchell shoes.


Eligibility criteria:
inclusion criteria: * less than 12 months old (no age minimum) * no neuromuscular disease involved * treated by ponseti casting * idiopathic bilateral or unilateral clubfoot * no other congenital foot deformity * no previous open surgeries to treat the deformity exclusion criteria: * patients with prior surgical treatment * not treated by ponseti casting * an underlying syndrome * neurological disorder
statins at the primary care level

Conditions: Dyslipidemia

Summary: hypercholesterolemia, a major cause of disease burden in both the developed and developing world, is estimated to cause 2.6 million deaths annually (4.5% of all deaths) and one third of ischemic heart diseases., and result in 29.7 million daly lost. in argentina, the prevalence of hypercholesterolemia increased between 2005 and 2013 from 27.9% to 29.8%, whereas the rate of non-optimal ldl-c, was 28.0%. the rate of high cholesterol awareness was 37.3 % and the proportion of those who are under pharmacological treatment was dismally low: only 11.1%. furthermore, only one out of four subjects with a self-reported diagnosis of coronary heart disease (chd) is taking statins. and most individuals with chd who are on statins have sub-optimal ldl-c levels. although other antihypertensive, antidiabetic and low-dose aspirin were available free-of-charge at the primary care clinics of the public sector, statins had not been included until recently. as of 2014, statins (simvastatin 20mg) were incorporated into the package of drugs provided free-of-charge for patients with high cholesterol, according to cvd risk stratification. the goal of this study is to test whether a multifaceted educational intervention targeting physicians and pharmacist assistants, improves detection, treatment and control of hypercholesterolemia among uninsured patients with moderate to high cardiovascular risk in argentina. specifically, the intervention will test whether a multifaceted educational intervention program lowers ldl-cholesterol levels and cvd risk in moderate to high cardiovascular risk patients, improves physician compliance with clinical practice guidelines, and improves patient care management and adherence to medication. a cost-effectiveness study will be conducted to compare the intervention to the usual standard of care. this randomized cluster trial will enroll 350 patients from 10 public primary care clinics who will be assigned to receive either the intervention or the usual care. this study is timely and will generate urgently needed data on effective and, practical and sustainable intervention programs aimed at the prevention and control of cvd risk that can be directly used in other primary care settings and health care systems in lmics.


Eligibility criteria:
inclusion criteria: * arteriosclerotic cardiovascular disease: defined as acute coronary syndrome; history of myocardial infarction, stable or unstable angina, coronary revascularization, stroke, or transient ischemic attack presumed to be of atherosclerotic origin and revascularization. * moderate-high cvd risk according to the who charts adapted by the national moh (estimated 10-year cvd risk ≥ 20%) * ldl-c level ≥ 190 mg/dl * type 2 diabetes in patients between 40 and 75 years of age exclusion criteria: * patients that are already receiving statins, pregnant women, bed-bound, and patients who cannot give informed consent. * end stage chronics kidney disease receiving dialysis ,hiv/aids, tuberculosis, alcohol or drugs abuse.

Keywords: dyslipidemia global cardiovascular risk statins educational interventions
remote ischemic preconditioning in patients undergoing acute minor abdominal surgery

Conditions: Acute Cholecystitis; Endothelial Dysfunction

Summary: this study examines if remote ischemic preconditioning in patients undergoing minor acute abdominal surgery (laparoscopic cholecystitis due to acute cholecystitis) is associated with a modulation of endothelial dysfunction. half of the patients will receive remote ischemic preconditioning prior to surgery, the other half will serve as controls.

remote ischemic preconditioning (ripc) consists of cycles of forearm or leg ischemia and reperfusion by the inflation of a blood-pressure cuff over the systemic blood pressure for brief periods. the procedure is simple, safe and with no clear side effects. in clinical studies covering acute cardiology ripc has effectively reduced myocardial injury, postoperative cardiovascular complications and cardiac mortality. recently, the effect of ripc on attenuating ischemia-reperfusion injury has been investigated in non-cardiac surgery as well. the organ specific ischemia-reperfusion injury, systemic oxidative stress and inflammatory response were attenuated due to the intervention but a complete understanding of the underlying protective mechanisms of ripc is however still lacking. experimental and clinical studies have implicated that the stimulus of ripc is transmitted from the preconditioned tissue to other tissues and organs by humoral, neural and systemic anti-inflammatory mediators. the humoral and neural pathway are thought to be dependent on endogen substances such as adenosine, bradykinin, nitrogen oxide (no) and calcitonin-gene-related-peptide (cgrp).

Eligibility criteria:
inclusion criteria: * patients undergoing acute or subacute cholecystectomy due to acute cholecystitis with a maximum of 7 days of symptoms prior to surgery exclusion criteria: * not capable of giving informed consent after oral and written information * surgery within 30 days of study inclusion * conditions that prevent the performance of remote ischemic preconditioning on the upper extremity, e.g. fractures, paresis, lymphedema * performance of concomitant endoscopic retrograde cholangiopancreatography (ercp) during surgery * synchronous pancreatitis * synchronous cholangitis

Keywords: remote ischemic preconditioning (ripc) acute surgery acute cholecystitis endothelial dysfunction heart rate variability (hrv)
a study to confirm the efficacy and safety of fludarabine phosphate administered in untreated chronic lymphocytic leukemia patients with anemia and/or thrombocytopenia

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Summary: the purpose of this study is to confirm the efficacy and safety of fludarabine phosphate administered with dose increasing in 6 cycles (1 cycle: 5 treatment days every 28 days) in untreated chronic lymphocytic leukemia (cll) patients with anemia and/or thrombocytopenia.

as of 29 may 2009, the clinical trial sponsor is genzyme corporation. note: this study was originally posted by sponsor schering ag, germany, which was subsequently renamed to bayer schering pharma ag, germany.

Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed cll * patients with hemoglobin concentration and/or platelet count below the institution's lower limit of normal * patients who have not received cancer chemotherapy or radiotherapy exclusion criteria: * patients with apparent infections (including viral infections) * patients with serious complications (heart, liver, or kidney disease, etc.) * patients with a serious bleeding tendency (e.g., dic) * patients with serious cns symptoms * patients with fever \>= 38°c (excluding tumor fever) * patients with interstitial pneumonia or pulmonary fibrosis * patients with active multiple cancers * patients receiving other investigational products within 6 months before registration in this study * patients with prior allergies to medications that are similar to the investigational product (purine nucleoside derivatives) * women who are pregnant, of childbearing potential, or lactating
determination of safe and effective dose of romiplostim (amg 531) in subjects with myelodysplastic syndrome (mds)receiving hypomethylating agents

Conditions: MDS; Myelodysplastic Syndromes; Thrombocytopenia

Summary: the purpose of this study is to evaluate the effect of romiplostim (amg 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk myelodysplastic syndrome (mds) receiving hypomethylating agents. it is hypothesized that romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk mds subjects receiving hypomethylating agents.


Eligibility criteria:
inclusion criteria: - diagnosis of mds by bone marrow biopsy based on the world health organization (who) classification - low, intermediate-1 or intermediate-2 risk category mds using the ipss (international prognostic scoring system) - planned to receive either azacytidine 75 mg/m2 by subcutaneous administration each day for 7 days or decitabine 20 mg/m2 by intravenous administration each day for 5 days for at least 4 cycles exclusion criteria: * prior exposure to \>3 cycles hypomethylating agents * prior history of leukemia or aplastic anemia * prior history of bone marrow transplantation * prior malignancy (other than in situ cervical cancer or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ³ 3 years before randomization * active or uncontrolled infections * unstable angina, congestive heart failure \[nyha (new york heart association) \> class ii\], uncontrolled hypertension \[diastolic \> 100 mmhg\], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction * history of arterial thrombosis ( eg, stroke or transient ischemic attack) in the past year * history of venous thrombosis that currently requires anti-coagulation therapy * received il-11 within 4 weeks of screening * less than 4 weeks since receipt of any therapeutic drug or device that is not fda approved for any indication * have previously received any other thrombopoietic growth factor

Keywords: mds myelodysplastic syndromes refractory cytopenias thrombocytopenia
aprepitant ,olanzapine,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting

Conditions: Chemotherapy-induced Nausea and Vomiting

Summary: the purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in combination with olanzapine ,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (cinv) in patients receiving highly or moderately emetogenic chemotherapy.

eligible patients will be randomized to receive different antiemetic regimens . in the experimental group,patients will receive aprepitant,olanzapine ,palonosetron and dexamethasone .in the other group,patients will accept the same dose of aprepitant ,palonosetron and dexamethasone .during the treatment, any grade of nausea and vomiting should be recorded in order to evaluate the complete response rate of cinv,nausea patients will be measured by a visual analogue scale (vas) ,other adverse events should be recorded as well.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. histologically or cytologically confirmed malignant disease 3. accept chemotherapy for the first time 4. patients who will receive high emetogenic cancer chemotherapy (hec) (cisplatin\>=70mg/m2,adriamycin in combination with cyclophosphamide ,cyclophosphamide\>=1500mg/m2,adriamycin\>60mg/m2,epirubicin\>90mg/m2,dacarbazine，ifosfamide\>=2g/m2) or moderate emetogenic chemotherapy cancer (carboplatin\>=300mg/m2,cyclophosphamide\>=600-1000mg/m2,adriamycin\>50mg/m2) 5. written informed consent exclusion criteria: 1. pregnant or breast-feeding 2. uncontrolled psychosis history 3. inability or unwillingness to understand or cooperate with study procedures 4. central nervous system tumors primary or secondary 5. concurrent abdominal radiotherapy 6. history of uncontrolled diabetes mellitus 7. patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma. 8. known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month 9. pre-existing nausea or vomiting 10. inadequate hematological function and abnormal liver and renal function. 11. history of sensitivity to olanzapine 12. concurrent application of quinolone antibiotic therapy 13. treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy. 14. cytochrome p450 3a4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide) 15. concurrent application of systemic corticosteroids 16. active infection or gastrointestinal dysfunction

Keywords: chemotherapy nausea vomiting
group a pharyngitis in children: the gaspard study

Conditions: Group A Streptococcal Pharyngitis

Summary: evaluate the necessity to treat with antibiotics gas pharyngitis in children in switzerland. the null hypothesis is that antibiotic treatment is not necessary for gas pharyngitis in this population.

all children between 3 -15 years old with clinical symptoms suggestive of pharyngitis (mc isaac score ≥3) and a microbiological test (rapid antigen detection) positive for group a streptococcus (gas) will be included in the study. in order to assess the strain of gas as well as to identify co-infected children with respiratory virus, a throat culture and a nasopharyngeal swab will be performed, as well as a standard questionnaire and a standard physical exam. at this time, children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment. during the treatment period, the investigators will ask the parents/legal guardians of the patients to pay close attention to the evolution of the symptoms (fever, pain, exudates...) as well as the treatment's adverse event, and to report their presence or absence in a dairy form. at day three after initiation of treatment, a standardized clinical evaluation will be completed by phone to identify if the patient still has symptoms of pharyngitis or signs of suppurative complications. one month after the inclusion in the study, a throat culture, a standardized questionnaire as well as a clinical evaluation will be performed to identify if the patient has or had signs of non-suppurative complications and non-resolving infection. six month and one year after inclusion, a phone call will evaluate the possible relapses, recurrences and complications of gas infection with a standardized questionnaire. gas strains will be analyzed to identify their unique fingerprint and viral coinfections will be reported to possibly identify cofactors for increased complication rates.

Eligibility criteria:
inclusion criteria: * 3 -15 years old * clinical symptoms suggestive of pharyngitis with mc isaac score ≥3 * rapid-antigen detection test (radt) positive for gas- * signed informed parental/patient consent form exclusion criteria: * hypersensitivity to b-lactams * concomitant disease which must be treated with antibiotics * chronic disease-immunocompromised * antibiotics within 72 h * history of arf,scarlet fever,impetigo,acute glomerulonephritis * family history of arf * complicated pharyngitis

Keywords: pharyngitis amoxicillin
the effects of clinical pilates training in patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the objective of this study was to examine the effects of 8-week clinical pilates training on disease-specific indices, core stability, and balance in ankylosing spondylitis (as) patients.

the objective of this study was to examine the effects of 8-week clinical pilates training on disease-specific indices, core stability, and balance in ankylosing spondylitis (as) patients. as patients were randomly assigned to either the pilates group (pg) or control group (cg). the pg participated in pilates training 3 times a week for 8 weeks. patients in the cg were instructed to follow a home exercise program 3 times a week for 8 weeks. assessments were performed before and after the interventions. outcome measures were disease-specific indices, core endurance, and balance. disease-specific indices were: bath as disease activity index (basdai), bath as functional index (basfi), bath as spinal mobility index (basmi), and the as quality of life (asqol) questionnaire. static core endurance was assessed with trunk flexor, extensor endurance, and lateral side bridge tests, while dynamic core endurance was assessed using modified sit-up test. balance was assessed with static, dynamic, and single-leg stance postural stability (ps) and limits of stability (los) tests using the biodex balance system sd.

Eligibility criteria:
inclusion criteria: * having as diagnosis based on modified new york criteria, * being 20-60 years of age, volunteering to participate in the study, * having no regular exercise habit in the last 6 months, * agreeing not to participate in any other type of physical exercise program during the study exclusion criteria: * not attending 4 consecutive pilates or home exercise sessions, * change in medication within the previous 6 months or during the study, * presence of neurological or coexistent systemic disease, history of orthopedic surgery, and active enthesitis

Keywords: ankylosing spondylitis pilates postural balance physical endurance flexibility
effect of nf-кb dependent proinflammation on osteogenic differentiation of the mesenchymal stem cells in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study determines whether nf-кb dependent proinflammatory state found in type 2 diabetes yield to a higher rage activation in the mesenchymal stem cell, as well as the effects of the proinflammation on osteoblast differentiation impairment and cellular apoptosis in type 2 diabetic patients. this study will compare non-diabetic control subjects and type 2 diabetic patients with metformin monotherapy failure in the aspect of 1) serum markers for nf-кb dependent proinflammatory state and its intracellular signals, 2) osteogenic differentiation and apoptosis of the mesenchymal stem cells, and 3) serum age, rage and cellular rage activation.

this study aims to explore whether proinflammation in type 2 diabetes is an mechanism underlined higher rage activation and osteoblast differentiation defect demonstrated in the msc of type 2 diabetes, as well as the effects of the proinflammation on cellular differentiation and apoptosis of the msc. type 2 diabetes was known to be in proinflammatory state due to nf-кb-dependent cytokine secretion (for example, tnf-α, il1 and il6), which in turn contribute to nf-кb upregulation. because rage expression is partly regulated by nf-кb signal, the nf-кb upregulation in proinflammatory state observed in type 2 diabetes may entail rage overactivation in this population. therefore, the proinflammatory state and its correlation to cellular nf-кb-dependent rage activation is noteworthy to be determined in the msc of type 2 diabetes. furthermore, the effect of proinflammation on differentiation potential and apoptosis of the msc in type 2 diabetes remains to be elucidated.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes who has hba1c higher than 6.5% with metformin monotherapy and age-matched non-diabetes control subjects who signed consent form to be in the study. exclusion criteria: * patients who use thiazolidinedione, steroid, immunosuppressive medications, antiresorptive agents or anabolic therapy for osteoporosis. * patients with elevated serum creatinine higher than 1.4 in female and 1.5 in male. * patients with metastases cancer or hematologic malignancy.

Keywords: type 2 diabetes rage osteoblast
bortezomib (velcade) - regulatory post marketing surveillance (pms)

Conditions: Multiple Myeloma

Summary: after the kfda (korea food and drug administration) approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the health authority in 6 years. in this observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (velcade).

after the kfda approval of a new drug, an annual report of the drug's safety and efficacy data must be reported to the health authority in 6 years. in this observational study, we will investigate the basic demographic, medical history, concomitant drug use, as well as dosing information of multiple myeloma patients using bortezomib (velcade). we will collect the response rate according to the embt (european group for blood and marrow transplant; a non-profit organization based in the netherlands that promotes the transplantation of haemopoietic stem cells from all donor sources and donor types and related basic and clinical research, education, standardization, quality control, and accreditation for transplant procedures) or imwg (the international myeloma working group) criteria and the adverse events to assess the efficacy and safety. observational study - no investigational drug administered

Eligibility criteria:
inclusion criteria: * patients who are newly prescribed bortezomib injection for the treatment of multiple myeloma exclusion criteria: * patients who are hypersensitive to the bortezomib or any component of the bortezomib or with a history of the hypersensitivity * patients with severe hepatic impairment * pregnant women

Keywords: bortezomib postmarketing surveillance korea bortezomib pms