Kornimate/medical-research-clean huggingface dataset:
pilot study of magnesium infusions in pediatric asthma

Conditions: Asthma

Summary: this is a prospective randomized pilot study that seeks to address the research question: in children with moderate-to-severe asthma, do intravenous magnesium infusions added to standard pediatric intensive care unit (picu)-level asthma care significantly decrease time from patient presentation until picu discharge?

this study will be a double-blind, prospective randomized pilot study. subjects will be randomized on a 1:1 basis to receive routine asthma care with or without a magnesium drip.

Eligibility criteria:
inclusion criteria: * age 2 years 0 days up to 20 years 364 days * clinical diagnosis of asthma including both of the following: * attending physician's primary working diagnosis is status asthmaticus * results of a modified international study of asthma and allergies in children (isaac) diagnostic questionnaire consistent with an asthma diagnosis * planned picu admission for moderate-to-severe asthma exacerbation persisting despite standard first-tier therapy (systemic corticosteroids and at least a one-hour treatment with nebulized albuterol/ipratroprium or equivalent) as evidenced by an asthma score of 7 or greater * iv access or equivalent * ability to understand and give informed consent/assent in english exclusion criteria: * prior enrollment in this study * prior adverse reactions to magnesium * use of systemic corticosteroids or magnesium in preceding 2 weeks, or administered at a transferring facility more than 3 hours prior to enrollment * admission for inpatient asthma care in preceding 2 weeks * hemodynamic instability, impending respiratory failure or intubation * inability in children age 7 years or older to give assent due to a developmental delay or altered mental status * significant renal or cardiac disease * sickle cell anemia * significant, active non-asthma pulmonary disease

Keywords: asthma magnesium adrenergic receptor
biological determinants of sputum rheology in chronic airway diseases

Conditions: Asthma; COPD; Bronchiectasis

Summary: the primary objective of this study is to investigate the biological determinants of sputum rheology variations.

secondarily, this study aims to compare rheology parameters between different chronic airway disease sub-populations.

Eligibility criteria:
inclusion criteria: * affiliate with or beneficiary of the french national single-payer health insurance system * patient capable of spontaneous mucus expectoration * consulting or hospitalized at the study centre inclusion criteria for the asthma group * never- or former-smoker (\<10 pack-years) * medical history compatible with asthma * reversible post-brochodilator (or post-corticosteroid test) ventilatory obstruction (ratio of forced expiratory volume in 1 second : forced vital capacity \< 70%) or significant variation in respiratory function -- or -- bronchial hyperresponsiveness demonstrated during a broncho-provocation test inclusion criteria for the copd group * current- or former-smokers (\>10 pack years) * chronic obstructive pulmonary disease according to gold criteria inclusion criteria for the bronchiectasis group * presence of bronchiectasis on computed tomography scan * cystic fibrosis has been ruled out exclusion criteria: * patient expresses opposition to the protocol * breast feeding or pregnant * metastatic neoplastic disease * other active pulmonary disease (tuberculosis, interstitial lung disease) * recent psychiatric disorder (in the past year and documented via a specialist consult) * consumption of illicit drugs or alcoholism * patients in an exclusion period determined by another study * patients under any type of legal guardianship * prisoners * impossible to correctly inform the patient * does not fluently read french * emergency situations
evaluation of a low-cost high resolution microendoscope for the detection of lower gastrointestinal neoplasia

Conditions: Colon Polyps; Colonic Dysplasia; Anal Dysplasia

Summary: the overall objective of this study is to obtain data to evaluate whether high-resolution imaging of the colon can assist clinicians in detecting dysplastic (precancerous) and neoplastic areas. this is a pilot study of a novel technology, a miniaturized microscope device which can be used during standard endoscopy to image the gastrointestinal epithelium. theoretically, by visualizing superficial mucosal changes at a high-resolution and magnification, the investigators will be able to obtain optical images that can be used to guide endoscopic biopsy and polypectomy. this may foster the selective targeting of dysplasia/neoplasia, thereby improving diagnostic accuracy.


Eligibility criteria:
inclusion criteria: * surveillance of polyps or disease of the colon * screening colonoscopy * anoscopy for suspected or known anal dysplasia or neoplasia exclusion criteria: * unfit for standard colonoscopy or anoscopy * unable to provide informed consent

Keywords: colon polyps colonic dysplasia anal dysplasia microendoscopy
metabolic causes of thrombosis in type 2 diabetes - question 4

Conditions: Type 2 Diabetes

Summary: hypoglycemia (low blood glucose level) occurs frequently in intensively treated patients with diabetes. although hypoglycemia was thought to occur almost exclusively in t1dm, with the advent of improved metabolic control in t2dm, the incidence of hypoglycemia is rising in these patients. therefore in this application, we will test the novel hypothesis that prior hypoglycemia will result in (cardiovascular complications) during subsequent hypoglycemia.

this study will test the hypothesis that 1) hypoglycemia causes a prothrombotic state and defective endothelial function and 2) episodes of repeated hypoglycemia will result in greater impairments of endothelial function and an increased prothrombotic tendency. preliminary data in healthy men demonstrates that hypoglycemia can dramatically increase pai-1 levels and the pai-1 to tpa ratio, thereby creating a prothrombotic state. whether this also occurs in type 2 dm patients is unknown. furthermore, the effects of hypoglycemia on endothelial function in t2dm are also unknown.

Eligibility criteria:
inclusion criteria * 14 (7 female/ 7 male) type 2 diabetic patients age 18-60 yrs * 14 (7 female/ 7 male) non-diabetic controls age and weight matched * body mass index \>20 kg/m2 * normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities * female volunteers of childbearing potential: negative hcg pregnancy test * volunteers over 40 years old: normal baseline cardiac stress test * for those with type 2 diabetes: hba1c \>5.5% * for those with type 2 diabetes: diabetes \< 20 years * for those with type 2 diabetes: c-peptide \>0.2 nmol (1.1-4.4 ng/ml). if c-peptide is abnormal or there is a clinical suspicion of type 1 diabetes, mody, or lada, anti-islet cell (negative) and glutamic acid decarboxylase (gad) antibody negative (0.0-1.5 u/ml) will be performed exclusion criteria * uncontrolled hypertension * history of cerebrovascular incidents * pregnancy * subjects unable to give voluntary informed consent * subjects with a recent medical illness * subjects on anticoagulant drugs, anemic, or with known bleeding diseases * tobacco use physical exam exclusion criteria * blood pressure greater than 150/95 * clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, s-t segment deviations, ect.) from history or from cardiac stress testing * pneumonia * hepatic failure/jaundice * renal failure * acute cerebrovascular/ neurological deficit * fever greater than 38.0 c screening blood tests exclusions according to protocol

Keywords: type 2 diabetes endothelial function fibrinolytic balance hypoglycemia
effects of phytonutrients upon muscle perfusion in response to feeding

Conditions: Biological Aging

Summary: this is a random order cross over design trial to evaluate the efficacy of select nutritional ingredients on enhancing muscle perfusion in response to an acute meal stimulus.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) 18-30 kg/m2 * free from active metabolic disease * normotensive exclusion criteria: * habitual gym use or formal exercise (more than once a week) or other routine strenuous physical activity * smokers * surgery within past 3 months * active cardiovascular disease * taking beta-adrenergic blocking agents * cerebrovascular disease: * active respiratory disease * active metabolic disease * active inflammatory bowel or renal disease * active malignancy or until confirmed remission * clotting dysfunction * history of dvt * significant musculoskeletal or neurological disorders * family history of early (\<55y) death from cardiovascular disease * known sensitivity to sonovue contrast agent * known allergy or intolerance to any of the study ingredients * current use of any of the study ingredients
new cardiovascular risk screening strategy.

Conditions: Cardiovascular Prevention; Screening; Peripheral Artery Disease; Arteriosclerosis; Asymptomatic

Summary: mortality due to cardiovascular disease (cvd) in spain accounted for 29% of all deaths (32% in women and 26% in men) in 2017. out of those, 67% were related to a coronary or a cerebrovascular disease . a key strategy in primary prevention of cvd is to use risk functions to individualize preventive interventions for each patient. the current cv risk-screening program in some regions of spain, is based using an adapted framingham scale, regicor's risk function, which is integrated in the primary care electronic health record. this risk function predicts the probability within 10 years of developing a coronary event. however, this function fails to identify patients that fall into low- or intermediate-risk level, and might develop a cv event in the up following 10 years. ankle-brachial index (abi) is a simple, non-invasive and economic technique, which allows detecting peripheral arterial disease (pad), and gives independent risk function information compared to other coronary risk functions. even tough, between 13-27% of middle age population have an abi ≤ 9, around 50-89% of them do not exhibit any symptoms. however, they hold higher mortality risk and cv events. current clinical guidelines for pad screening, have a limited level of evidence, and only recommend using abi on patients aged 50-70, who have diabetes or are smokers, and patients older than 70 years old. a new risk function, reason, to assess cvd risk has been designed. this model has proven to improve predictive capacity of holding an abi ≤ 0.9 on those patients aged 50-74 that are apparently free of cvd. therefore, a strategy that combines the current cv risk estimation using regicor, and the prediction capacity of pathologic abi with reason, would allow detecting high-risk patients with a pad screening program. it is possible that patients, who hold an abi ≤ 0.9, even if being asymptomatic, will adopt physician's recommendations on healthy life habits and preventive treatment. the aims of this study are: * to assess the effectiveness and cost-utility of adding a screening program with abi to the current strategy of cv risk detection to reduce the incidence of cvd and mortality from all causes in the population aged 50 to 74. * to assess the effectiveness of adding a screening program with abi to the current strategy of cv risk detection to improve cardiovascular risk factors in the population aged 50 to 74.


Eligibility criteria:
inclusion criteria: * patients aged 50 to 74, which are free or do not have previous history of cvd. patients that hold a regicor cv risk score ≥7, and reason risk core ≥7, during a routine primary care visit exclusion criteria: * symptomatic pad * coronary disease * stroke * cardiac revascularization
pilot study of the predictive value of trem1 expression and activation in inflammation and radio-induced mammary fibrosis

Conditions: Radiation Toxicity; Fibrosis; Breast Cancer

Summary: breast cancer is the most common cancer in the world. half of patients with such cancer are treated with radiation therapy. some patients will develop cutaneous or subcutaneous fibrosis, more or less bothersome. several studies have shown a correlation between an inflammatory reaction and a protein, called trem-1. but to date, no link has been proven between trem-1 and inflammation / fibrosis in the phenomena of fibrosis induced by radiotherapy in patients with breast cancer. our study aims to understand the involvement of this trem-1 protein in the development of fibrosis or radio-epidermis in patients with breast cancer.


Eligibility criteria:
group a 1. patients over 18 years old, 2. breast cancer (adenocarcinoma in situ or invasive) 3. non-metastatic disease 4. radiotherapy after conservative surgery with irradiation of the breast alone and complement on the operating bed (optional) completed two to six months ago 5. absence of postoperative complications 6. early radio-induced epidermis grade ≥2 (ctcae v4.0) persistent at inclusion 7. chest circumference \<120 cm and cup \<e, 8. absence of breast reconstructive surgery, 9. signature of informed consent, 10. affiliation to a social security scheme for french patients. group b 1. patients over 18 years old, 2. breast cancer (adenocarcinoma in situ or invasive) 3. non-metastatic disease 4. radiotherapy after conservative surgery with irradiation of the breast alone and complement on the operating bed (optional), completed two to six months ago 5. absence of postoperative complications 6. early grade 0-1 radiation-induced epidermis (ctcae v4.0) at inclusion 7. chest circumference \<120 cm and cup \<e, 8. absence of breast reconstructive surgery, 9. signature of informed consent, 10. affiliation to a social security scheme for french patients. groups c, d patients included in the splicirad study who have formulated their agreement for the use of supernumerary samples at the time of inclusion: * 10 patients with late pathologic radio-induced fibrosis (more than 6 months after the end of radiotherapy), grade ctcae v4.0 ≥ 3 vs. * 10 patients without late pathological radio-induced fibrosis of grade ctcae v4.0 ≤ 1 (follow-up after rt ≥4 years) group e patients over 18 who have given their consent to the blood establishment for the use of their samples for research purposes. non-inclusion criteria for groups a, b, c, d: 1. systemic inflammatory disease associated with individual radiosensitivity 2. dermatological pathology in the breast 3. radiotherapy having delivered an overdose\> 107% of the prescribed dose in at least 10% of the ptv 4. diabetes 5. active smoking 6. chronic systemic anti-inflammatory therapy, immunotherapy, immunosuppressants, anti-tnf
clinical trial of topical abl01 treatment of onychomycosis

Conditions: Onychomycosis of Toenail

Summary: this clinical trial seeks to investigate if an experimental medical device, abl01, can be used to treat onychomycosis. in a 1-year trial the effectiveness of abl01 will be tested against placebo in 70 study subjects with onychomycosis of the big toe nail. the endpoint of the trial is clinical improvement and cure at the 6 and 12 month time-point.

the purpose of this clinical trial is to determine the safety and effectiveness of the medical device abl01. the intended use of abl01 is to reduce and treat onychomycosis, fungal nail infection. abl01 is a solution intended to be topically administered weekly to infected nails. the trial is designed as a double blinded randomized placebo controlled clinical trial. the trial involves 70 study subjects, half of which will receive abl01 and the other half placebo. the inclusion criteria for study subjects are adult men and women that present with distal lateral subungual onychomycosis (dsu) on the big toe nails. furthermore, the extent of dsu should not involve more than half of the area of the nail. the study subjects will themselves apply the study solution weekly to the treated nail. the trial will run for 6 months with a possible extension to maximum 12 months. there will be a total of 4 study visits at baseline, 3, 6 and 12 months to follow up the progress of the trial. the primary objective of the trial is to determine if abl01 treatment are able to reduce and treat onychomycosis. secondary objectives are to collect safety data, determine if the abl01 are perceived as easy to use and assess long term effects of the treatment. the endpoint of the trial is reduction in clinical signs or complete cure of onychomycosis at the 6- or 12-month time-point.

Eligibility criteria:
inclusion criteria: * provision of written informed consent * men and women above age 18 weighing over 40 kg * present with distal lateral subungual onychomycosis of any of the big toe nails * the onychomycosis should involve less than 50 % of the nail bed and may not have reached the cuticle exclusion criteria: * unable to come for study visits * known allergy to any of the components in abl01 * not willing to participate in the trial or not able to understand the content of the trial * present with proximal subungual onychomycosis or superficial onychomycosis. * present with distal lateral subungual onychomycosis of other nails than the big toe. * more than 50 % of the nailbed affected by onychomycosis or the cuticles infected * known conditions (like psoriasis) that cause abnormal nail appearance * nail damage caused by trauma, pressure or other mechanical reasons * currently on immunosuppressive therapy * showing signs of poor peripheral blood circulation * used another topical antifungal treatment within 1 month of screening * used a systemic antifungal treatment within 3 months of screening * participated in any other clinical onychomycosis trial in the previous 3 months
preventing alcohol withdrawal syndrome with oral baclofen

Conditions: Alcohol Withdrawal Syndrome

Summary: adult medical/surgical inpatient hospital care is more difficult and more expensive when complicated by alcohol dependency (ad), especially for patients who develop alcohol withdrawal syndrome (aws). aws can be mild, moderate or severe. the severity of ethanol withdrawal scale (sews) is tool used to assess severity and is the current standard of care for both monitoring and treating aws at denver health. moderate/severe aws (i.e., sews ≥ 7) has important clinical implications and requires pharmacological treatment. at present, there are no safe and effective options for preventing aws in at-risk inpatients. baclofen is a gaba-b receptor agonist that has been used in the alleviation of spasticity in patients with multiple sclerosis since the 1970s. baclofen has shown promise in the management of alcohol dependency in preclinical and clinical studies. we propose to examine baclofen in the prevention/amelioration of aws in adult medical inpatients. the investigators hypothesize that baclofen, as compared to placebo, will significantly reduce the number of adult inpatients with ad who will develop moderate/severe aws (sews ≥ 7) when assessed at 72 hours after enrollment. further the investigators hypothesize that baclofen, as compared to placebo, will significantly reduce the need for symptom-triggered benzodiazepine administration during the 72 hours of hospitalization. these hypotheses will be tested in adult inpatients who are determined to be at risk for alcohol withdrawal and are subsequently placed on the sews monitoring and treatment protocol. these patients will be randomized to baclofen 10mg three times daily vs placebo.

see brief summary. patients will recieve standard of care treatment and monitoring for etoh withdrawl per our insitution wide sews protocol. they will then be randomized to recieve baclofen 10mg tid vs placebo tid for the course of their hospital stay or 7 days, whichever comes first.

Eligibility criteria:
inclusion criteria: * adults age 21-100 admitted to medical floors at denver health * patients placed on sews protocol by admitting physicians (at risk for aws). exclusion criteria: * unable to provide informed consent * unable to take oral medications * admitted for aws or with sews score \>7 at baseline * no alcohol intake for ≥ 48 hours * baclofen use at baseline * baclofen sensitivity * hospital discharge anticipated in within 48 hours * pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential * other active drug dependence (except tobacco) * taking a medication known to interact with baclofen.
early small bowel obstruction following laparotomy for trauma

Conditions: Small Bowel Obstruction

Summary: the formation of intraperitoneal adhesion following abdominal surgery is accepted by clinicians as an inevitable consequence. more than 90% of patients undergoing a surgical procedure in the abdomen will develop intraperitoneal adesions. the incidence however, of small bowel obstruction (sbo) resulting form these adhesions is far lower. to date, it is unknown which risk factors predispose these patients to develop sbo. several have been proposed, such as age, peritonitis, or surgery for small bowel injury resulting from gunshots. none of them however, has been widely accepted. during the last 20 years the significant lifetime risks associated with this phenomenon and its impact on the quality of life of patients has been well recognized. in addition, the burden on healthcare resources due to complications caused by adhesions is increasing and medicolegal consequences are rapidly evolving. early sbo following laparotomy for trauma is a poorly described entity. a few retrospective, single institution studies with a low number of patients have tried to address this issue. however, these studies either included a subset of trauma patients, i.e. patients sustaining penetrating trauma,\[4\] or patients undergoing a negative or non-therapeutic laparotomy, or examined only the incidence of sbo requiring surgical intervention. in addition, recent data regarding this issue is lacking, especially after the implementation of the damage control concept and the other advances in trauma surgery. the aim of this study is to define the incidence of early sbo following laparotomy for trauma and to examine possible risk factors associated with its development.

this is a retrospective review of all trauma patients admitted to the los angeles county - university of southern california (lac+usc) medical center from january 2006 to june 2009 (3.5 years). the trauma registry will be utilized to identify patients \>= 15 years old who underwent a laparotomy during the study period and survived \> 72 hours. for patients meeting inclusion criteria, all imaging studies obtained within the hospital course will be reviewed to identify patients who developed early sbo. the rationale for utilizing imaging studies is that obtaining these studies for patients with high suspicion of sbo is standard practice to establish the diagnosis. the charts of these patients will subsequently be reviewed and data will be collected using a predefined data collecting form.

Eligibility criteria:
inclusion criteria: * exploratory laparotomy * survival \> 72 hours exclusion criteria: * no exploratory laparotomy * survival \<= 72 hours

Keywords: adhesions small bowel obstruction ileus