Kornimate/medical-research-clean huggingface dataset:
improving asthma care through parental empowerment

Conditions: Asthma

Summary: the overall aim of this study will be to perform a prospective randomized clinical trial of an enhanced version of the impact dc intervention involving short-term case management to facilitate pcp follow-up appointments and to provide education for parents about how to communicate more effectively with their children's pcps as a means (1) to improve the rate of utilization of primary care services for ongoing asthma care and (2) to enhance the self-efficacy of parents in their interactions with their children's provider regarding the child's asthma care needs in 150 parents of high risk children referred within the impact dc asthma clinic.

asthma is the most common chronic disease of childhood, and it disproportionately affects urban, minority, and disadvantaged children. when implemented correctly, existing evidence-based guidelines from the national heart, lung, and blood institute (nhlbi) improve pediatric asthma care and outcomes. one key component of these guidelines is the importance of longitudinal care as part of a partnership among patient, parents, and a healthcare provider. such a partnership depends on effective communication of healthcare status by parents to providers. improving the communication skills of inner-city parents may improve their ability to obtain more effective longitudinal asthma care within their primary care homes and thereby to improve their child's asthma health outcomes. impact dc ("improving pediatric asthma care in the district of columbia") is a locally validated emergency department (ed) based intervention that improves multiple measures of asthma care and outcomes through an intensive short-term program of asthma education, medical care, and care coordination. in spite of these successes, achieving increased subsequent contact and partnership with primary care providers (pcps) for asthma care after the intervention has not been successful. therefore, for the current study, we propose to assess the effectiveness of an enhanced version of the existing impact dc intervention consisting of short-term case management by trained asthma educators.

Eligibility criteria:
inclusion criteria: * ages between 12 months and 12 years, inclusive * prior physician diagnosed asthma * ability of the parent to identify a specific pcp for their child * public insurance covering the child * parent/guardian available for interview exclusion criteria: * significant medical co-morbidities * enrollment in another asthma research intervention study * unavailability for telephone follow-up * primary language of the caregiver other than english

Keywords: parental empowerment parent self-efficacy
comparison of propofol requirement between patients with pituitary somatotroph tumor and with nonfunctioning pituitary tumor in transsphenoidal pituitary surgery under total intravenous anesthesia

Conditions: Pituitary Tumor

Summary: investigators hypothesized that propofol dose for pituitary somatotroph patients might differ from nonfunctioning pituitary tumor, and investigators will evaluate a target controlled infusion (tci) effect site concentration (ce) of propofol for bis score of 40 and loc (loss of consciousness) in pituitary somatotroph patients in comparison with non functioning pituitary tumor patients. on arrival in the operating room, standard monitoring devices, including electrocardiogram, pulse oximetry, noninvasive blood pressure cuff, and bispectral index (bis) will be applied to the patients. propofol with the modified marsh pharmacokinetic parameters using a keo of 1.2/min will be administered through tci pump (orchestrabase primea, fresenius vial, france). the initial target ce of propofol will be chosen as 3.0 mg/ml (0.5 mg/ml of incremental size) based on an earlier study. the sedation of patients will be assessed with bis score and the modified observer's assessment of awareness and sedation (oaa/s). loc was defined as an oaa/s lower than 2 (loss of response to spoken command to eye opening and loss of response to mild prodding or shaking). the primary end point of this study is the ce of propofol when the bis score is 40. the secondary end point of this study is the ce of propofol at loc.


Eligibility criteria:
inclusion criteria: * patients with pituitary somatotroph tumor and with nonfunctioning pituitary tumor in transsphenoidal pituitary surgery * american society of anesthesiologists classification 1 or 2 exclusion criteria: * left ventricle ejection fraction \ 3:1 * serum creatinine \> 1.0mg/dl * myocardial infarction or cerebral stroke in 1 yrs * fever \> 38c * dementia, cognitive disorder, confused mental status * pregnant patients * allergic to propofol * illiteracy or foreigners
trial of the treatment of chronic laryngitis with amitryptiline

Conditions: Laryngeal Diseases; Chronic Laryngeal Neuropathy

Summary: the study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.

the study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis. at the baseline visit, subjects will be assigned at random to amitriptyline or placebo which they will take for 8 weeks. subjects will be seen in the clinic at baseline and at 8 weeks. improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage.

Eligibility criteria:
inclusion criteria: * age 18 or older and able to consent for themselves. * structural pathology such as tumor previously ruled out using flexible laryngoscopy. * able to speak and read the english language. * failed a trial of a proton pump inhibitor for the treatment of gastopharyngeal reflux. * women under 55 years of age who may become pregnant must have a negative pregnancy test and agree to barrier or hormonal methods of contraception during the study. exclusion criteria: * environmental allergies. * smoking within past 5 years. * using ginko bilboa (or unwilling to cease using it). * current upper respiratory infections. * use of narcotics (e.g. oxycodone, methadone). * any prior history of amitryptiline use. * use of monoamine oxidase inhibitors (maois) within the past 4 weeks (selegiline, phenelzine, tranylcypromine, isocarboxazid, rasagiline, phenelzine sulfate, selegiline hydrochloride, rasagiline mesylate, tranylcypromine sulfate). * history of urinary retention. * any history of major depressive disorder. * any prior history of allergy to a tricyclic antidepressant. * current diagnosis of gastroesophageal reflux (gerd). * for women 18-55 years of age without history of menopause: currently nursing or pregnant, plans to become pregnant, or unwillingness to utilize contraception (barrier or hormonal methods).

Keywords: laryngeal sensory neuropathy
ferrous sulfate versus iron amino acid chelate

Conditions: Iron Deficiency

Summary: iron deficiency and depleted levels of iron are the most prevalent nutritional deficiency and the leading cause of anemia in the world; this can occur at any age, but preschool children are at particular risk of developing it. this condition may cause serious repercussions for life, being a public health threat of considerable importance worldwide. food fortification is considered the most effective solution to counter this situation, because it can help more people than other solutions. it is going to carry out a community trial to compare the efficacy of ferrous sulfate with respect to iron amino acid chelate as a dietary supplement in preschool children of medellin with depleted levels of iron; in terms of increasing ferritin levels in blood and maintain hemoglobin levels. it is hypothesized that at the end of the study the effect of milk fortified with iron amino acid chelate won't be less than the effect of fortified with ferrous sulfate. it is hoped that the results may contribute, albeit indirectly, to improve the health status of children with depleted levels of iron whom consume iron-fortified products.


Eligibility criteria:
inclusion criteria: children who * belong to institute fan in medellín * attend full time to institute fan (eight hours) * have 2 to 5 years inclusive * submit depleted levels of iron (ferritin level equal to or less than 24 mg/l) exclusion criteria: children who * submit anemia (hemoglobin level equal to or less than 11 g/dl) * have not stool analysis before intervention

Keywords: iron deficiency child, preschool dietary iron ferrous sulfate bis-glycino iron ii
anidulafungin pharmacokinetics given as a single intravenous dose to obese patients (adopt)

Conditions: Obesity Morbid

Summary: because anidulafungin is generally well tolerated and appears to have limited interaction with other drugs, it is a potential important agent in the treatment of invasive fungal infections. although anidulafungin is approved for the treatment of invasive candidiasis in adult non-neutropenic patients, dosing guidelines for anidulafungin in (morbidly) obese patients are not available. subsequently, the pharmacokinetic profile of anidulafungin (as well as other echinocandins) in this specific patient population is still largely unknown. during endoscopic gastric bypass surgery, patients are more prone to various kinds of infection, justifying the prophylactic use of anidulafungin in this specific cohort of patients. to build a valid pharmacokinetic model, obese patients with a bmi ≥ 40 undergoing endoscopic gastric bypass surgery will receive a single dose of 100 mg anidulafungin (besides standard anti-bacterial prophylaxis) and a pk-curve will be drawn. these pk-values can then be compared to the pharmacokinetics in a normal-weight group.

all obese patients with a bmi ≥ 40 kg/m2 undergoing endoscopic gastric bypass surgery who receive a prophylactic single dose of 100 mg anidulafungin will be included in the analysis. a pk curve will be determined after administration of anidulafungin at t=0.5, 1, end of infusion, 2, 4, 6, 8, 10, 12, 24, and 48 and (if feasible) 72 hours post infusion (n=12 samples). blood samples (4 ml) on pk days will be taken to obtain at least 2.0 ml of plasma.

Eligibility criteria:
inclusion criteria: 1. patient has a bmi ≥40 kg/m2 and is undergoing endoscopic gastric bypass surgery. 2. subject is at least 18 years of age on the day of screening. 3. if subject is female: neither pregnant, nor able to become pregnant and is not nursing an infant. 4. subject or legal representatives are able and willing to sign the informed consent before screening evaluations. exclusion criteria: 1. documented history of sensitivity to medicinal products or excipients similar to those found in the echinocandin preparation. 2. history of, or current abuse of drugs, alcohol or solvents. 3. inability to understand the nature of the trial and the procedures required.

Keywords: anidulafungin gastric bypass morbidly obese pharmacokinetics prophylaxis yeast infection
management of venous thromboembolism in france: a national survey among vascular medicine physicians

Conditions: Survey; Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; Anticoagulant

Summary: in france, venous thromboembolic (vte) disease is usually managed by vascular medicine physicians (vmp). the national optimev study, conducted more than 12 years ago among vmp practicing in hospital and in the community described the management of vte in routine clinical practice. since then a large number of practice changing studies have been published. this includes trials that have validated the use of direct oral anticoagulants (doac), the new standard of care of vte, as per new national and international guidelines. management of vte in 2019 appears to be significantly different from the one that prevailed more than 10 years ago when the last national survey was conducted. it is therefore important to have an update on the routine clinical practice management of vte by vmp. in this perspective the investigators aim to conduct a national survey among vmp practicing in france


Eligibility criteria:
inclusion criteria: * vascular medicine physicians who are active members of the sfmv (french society of vascular medicine) * vascular medicine physicians registered as willing to do medical research exclusion criteria: * vascular medicine physicians who refuse to provide consent * vascular medicine physicians who are retired * non-practicing vascular medicine physicians

Keywords: survey venous thromboembolism deep vein thrombosis pulmonary embolism anticoagulant clinical practice therapeutic management
the safety, tolerability, pharmacokinetic, and pharmacodynamic study of hec88473 in healthy subjects

Conditions: Non-alcoholic Steatohepatitis

Summary: a phase 1, double blind, placebo controlled, single and multiple ascending dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of hec88473 in healthy subjects

this is the first time hec88473 will be administered to humans. the aim of this study is to obtain safety, tolerability, pk, pd, and immunogenicity data of hec88473 sc administration as single and multiple ascending doses in healthy subjects.

Eligibility criteria:
inclusion criteria: 1. males or females, of any race, between 18 and 60 years of age, inclusive, at screening. 2. body weight ≥ 50 kg, and body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening. 3. in good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ecg, vital signs measurements, and clinical laboratory evaluations at screening as assessed by the investigator (or designee). 4. able to comprehend and willing to sign an icf and to abide by the study restrictions. exclusion criteria: 1. significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). 2. history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). 3. history of alcoholism or drug/chemical abuse within 2 years prior to the first dosing. 4. alcohol consumption of \> 21 units per week for males and \> 14 units per week for females. one unit of alcohol equals 12 oz (360 ml) beer, 1½ oz (45 ml) liquor, or 5 oz (150 ml) wine. 5. positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening and/or check-in. 6. immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to the first dosing or planned vaccination during the course of the study. 7. participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to the first dosing. 8. use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to first dosing, unless deemed acceptable by the investigator (or designee).
fetal hiv transmission risk and duration of membrane rupture

Conditions: Human Immunodeficiency Virus; HIV

Summary: in optimally managed hiv+ women with undetectable viral loads, who are on haart and also receiving intrapartum iv zdv, the risk of vertical transmission of hiv is independent of the length of time of rupture of membranes.

in developed countries, hiv infection is now considered a chronic disease and thus the life expectancy of people infected with hiv is approaching that of the general population. therefore many hiv positive women are choosing to pursue pregnancies. an important concern for antenatal and intrapartum management is decreasing the risk of vertical transmission. with the use of highly active antiretroviral therapy (haart) and intrapartum iv zidovudine (zdv) the risk of transmission is decreased significantly, however there is some debate surrounding optimal mode of delivery. possible mechanisms leading to perinatal transmission include transfusion of the mother's blood to the fetus during labour contractions, infection after rupture of membranes and direct contact of the fetus with infected secretions or blood from the maternal genital tract. when maternal viral load is detectable, the society of obstetricians and gynaecologists of canada (sogc) and other governing bodies recommend that elective cesarean section be performed for delivery as there is a 12-fold increased risk of perinatal transmission. however, the evidence suggests that for women at very low risk of transmission, such as those with an undetectable viral load and on haart, the benefit of transmission reduction provided by cesarean section may be negligible. the question of length of time of rupture of membranes prior to delivery and transmission risk has been a source of controversy, especially in the context of women on suppressive therapy (haart) with an undetectable viral load. traditional thinking has stated that the length of time of rupture of membranes should not be longer than 4 hours, as the benefit of cesarean section is lost after this time. however, this thinking is based on data where maternal viral loads were not known and only intrapartum iv zdv was used. many practitioners believe that in women with undetectable viral loads, virally suppressed on haart, the safest route of delivery is vaginal, irrespective of length of time of rupture of membranes. this is a retrospective cohort study which plans to examine the mode of delivery and median length of time of rupture of membranes for hiv positive women in two downtown academic institutions in toronto.

Eligibility criteria:
inclusion criteria: * all hiv positive women from january 2000 exclusion criteria: * women not on haart and who were not receiving intrapartum intravenous zidovudine

Keywords: human immunodeficiency virus (hiv) positive women
management of uncontrolled hypertension (htn)

Conditions: Hypertension

Summary: in this study, investigators will compare chronotherapy to abpm. data collected will include hypertension drug therapy regimen prior to and during the study, timing of medication administration, and dose, along with the patient's office blood pressure values prior to study and one month after modification in therapy. this will enable us to explore whether it is a practical endeavor to implement abpm as a routine process for all uncontrolled hypertension patients or whether abpm does not seem to provide considerable value over shifting the timing of drug administration.

investigators propose to conduct a pilot study to determine whether the incorporation of ambulatory blood pressure monitoring (abpm) as routine procedure in clinic for uncontrolled hypertension influences how anti-hypertensive drug therapy is modified or if simply shifting the dosing of anti-hypertensive medications to night time achieves similar results. investigators will enroll 20 participants with uncontrolled hypertension, who are prescribed 3 anti-hypertensive medications at maximum dose. all twenty patients will undergo 24-hour blood pressure monitoring with abpm at baseline and one month after change in therapy has been initiated; ten of the patients will be randomized to receive a shift in dosing schedule of anti-hypertensive medication to night-time without utilizing their abpm results while the remaining ten will receive modifications in therapy based on their abpm results and dipping status. the results of this study will assist in assessing the feasibility and benefits of the incorporation of abpm into the routine management of hypertension.

Eligibility criteria:
inclusion criteria 1. age ≥ 18 years 2. blood pressure of \>130/80 mmhg 3. currently receiving 3 anti-hypertensive agents, one of which is a diuretic, for at least six weeks exclusion criteria 1. vulnerable populations 1. pregnant women 2. prisoners 3. cognitively impaired persons 4. economically and/or educationally disadvantaged 5. human fetuses and neonates 6. patients who work night-shift 7. children 8. conditions with visual field deterioration (anterior ischemic optic neuropathy, glaucoma, optic nerve disorders)
double blind placebo controlled study on the effect of extracorporal shock wave therapy on erectile dysfunction in pde5i responders

Conditions: Erectile Dysfunction

Summary: this study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to pde5i therapy in a sham controlled randomized double blind manner.

this study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction. on screening patients will undergo evaluation by thorough medical history and by questionnaires for evaluation of sexual function. a one-month active treatment with pde5i will be provided followed by re-evaluation using the same questionnaires. then another one-month period without pde5i medication (washout period ) will be done and finally on the following visit evaluation will include the same questionnaires and if fit for inclusion- additional objective evaluation of endothelial function using the flow mediated dilatation technique and penile blood flow measurement by doppler ultrasound of the penis will be performed. at the end of this screening pahse the first shock wave session will be performed. altogether 12 treatment sessions will be performed - 6 treatments twice a week followed by a 3 week no-treatment interval and again 6 treatments twice a week. follow-up which will include the same evaluation as in the first treatment visit will be performed one month after end of treatment

Eligibility criteria:
inclusion criteria: * ed of more than 6 months * rigidity score ≥ 3 under pde5i therapy * shim ≤21 under pde5i therapy * non- hormonal, neurological or psychological pathology * stable heterosexual relationship for more than 3 months exclusion criteria: * prior prostatectomy surgery * any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities * clinically significant chronic hematological disease * anti-androgens, oral or injectable androgens * radiotherapy in pelvic region

Keywords: erectile dysfunction low intensity shock wave
breast: recovery after axillary node clearance - evaluating limbs with e-technology (the bracelet study)

Conditions: Breast Cancer; Mobility Limitation

Summary: this work aims to use wearable sensors to record the return towards normal physical activity after breast surgery. it will build on current evidence by using objective measures of activity and arm movements rather than patient reports.


Eligibility criteria:
inclusion criteria: * breast or axillary surgery exclusion criteria: * other diagnosed movement disorder * cannot consent due to language or capacity

Keywords: technology rehabilitation wearables breast surgery physical activity enhanced recovery after surgery