Kornimate/medical-research-clean huggingface dataset:
in-office placement of the propel mini sinus implant in the frontal sinus ostia

Conditions: Chronic Sinusitis

Summary: a randomized controlled trial

this is a prospective, randomized, single-blind, intra-patient controlled, multicenter trial with 50 subjects enrolled at up to 15 sites across the united states. study subjects undergo implant placement on one side following in-office balloon dilation, while the contralateral side undergoes balloon dilation only and serves as a control.

Eligibility criteria:
inclusion criteria * patient has provided written informed consent using a form approved by the reviewing irb. * patient is 18 years of age or older. * patient is willing and able to comply with protocol requirements. * patient has crs defined as sinonasal inflammation persisting for more than 12 weeks and complains of at least 2 of the 4 following symptoms: nasal blockage/obstruction/congestion, nasal blockage/obstruction/congestion, nasal discharge (anterior/posterior), facial pain/pressure, reduction/loss of smell * crs diagnosis confirmed by ct scan within 3 months prior to enrollment * bilateral frontal sinusitis confirmed by lund-mackay score of ≥1 on each side * post-endoscopic sinus surgery, patient has bilateral obstruction of the frontal sinus ostia by scarring and/or polypoid edema. * patient is a candidate for an in-office balloon dilation procedure. * in the opinion of the investigator, treatment with the propel mini sinus implant as an adjunct to balloon sinus dilation is technically feasible and clinically indicated in the frontal sinus ostia. exclusion criteria: * expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus of grade 3 or 4 unless reduced prior to randomization in the study. * oral-steroid dependent condition such as chronic obstructive pulmonary disease (copd) or other conditions. * known history of allergy or intolerance to corticosteroids or mometasone furoate. * clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis. * active viral illness (e.g., flu, shingles). * clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments through day 180 post-procedure. * currently participating in another clinical trial.

Keywords: frontal sinus balloon dilation
the analysis of factors influencing the vd of imipenem in septic shock patients

Conditions: Septic Shock

Summary: the study measures the plasma concentrations of imipenem in septic shock patients and non-septic shock patients and observes hypoalbuminemia and the impact of the severity of critical illness on vd

severe sepsis and septic shock are major causes of mortality in intensive care unit(icu) patients.correct and adequate antibiotic coverage is essential but can be complex as a result of fluid resuscitation, hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on pharmacokinetics(pk).such changes will significantly distort the normal anti-biotic pk profile, resulting in drug exposure that is markedly different from the 'healthy volunteer.'the apparent volume of distribution is one of important pk parameters.vd determines the loading dose. this review article considers these issues in detail, summarizing the key changes in antibiotic vd in the critically ill, and providing general suggestions how to optimization of antibiotic dosing to manage vd challenges.50 patients who receives the theapy of imipenem are included in this study.whether hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and the impact of critical illness on vd will be evaluted.

Eligibility criteria:
inclusion criteria: 1. age between 18 years old and 80 years old; 2. admitted to the icu; 3. patients diagnosed as septic shock requiring the therapy of imipenem(0.5g q6h or 1.0g q8h; exclusion criteria: 1. patient participated in another interventional trial before enrollment 2. allergy, hypersensitivity or a serious reaction to imipenem; 3. pregnancy. 4. patients with ecmo and(or)crrt. 5. tumors.

Keywords: septic shock; imipenem; vd ;pharmacokinetics
oral chemotherapy and platinum with radiotherapy followed or not by consolidation with the same chemotherapy in locally advanced non small cell lung cancer

Conditions: NSCLC

Summary: this is a multicenter, open-label, randomised, phase iii study of 2 cycles of oral vinorelbine in combination with cisplatin concurrently with radiotherapy randomised to either two more cycles of consolidation therapy with oral vinorelbine and cisplatin plus best supportive care (bsc) or bsc alone in patients with unresectable locally advanced non small cell lung cancer (nsclc). the primary objective is to compare progression-free survival in both arms, the secondary is to evaluate the response rate, overall survival in both arms, to evaluate the safety profile in both arms and to assess quality of life by the lcss questionnaire.


Eligibility criteria:
main inclusion criteria: * presence of at least one measurable lesion (recist criteria) * patients with a karnofsky performance status = or \> 80% * adequate pulmonary function, bone marrow, hepatic and renal functions main exclusion criteria: * patients with nsclc stage iv, with nsclc stages i, ii, iiia (except n2), with nsclc stage iiib with tumour extent or pleural effusion * symptomatic neuropathy \> grade 1 * hearing impairment = or \> grade 2 * concomitant/uncontrolled medical disorder * pregnant women

Keywords: untreated locally advanced inoperable stage iiia or stage iiib nsclc amenable to radical radiotherapy to a dose of 66 gy
functional magnetic resonance imaging in infants

Conditions: Healthy; Infant, Newborn, Diseases

Summary: the study proposes to evaluate cognitive development in infants four months or younger by functional mri and event related potential recording. fmri imaging will be obtained following an auditory stimulus inside the 4 tesla magnet at the center for magnetic resonance research and will be correlated with erp response to the same stimulus.


Eligibility criteria:
male or female infants less than 4 months old

Keywords: cognition infant development mri, functional
donor-derived ebv-specific t cells for life threatening ebv-lymphoma (olip-ebv-tcl-01-hmr01)

Conditions: EBV Associated Lymphoma

Summary: single-patient trial aiming to provide immunological consolidation following allogeneic stem cell transplantation to a young adult patient suffering from a systemic ebv-positive lymphoma of childhood.

following a presumed primary ebv infection, a 19 year old female patient rapidly suffered systemic inflammatory response, hemophagocytosis, multi-organ failure and evidence of ebv+ t-cell lymphoma. the patient was aggressively treated and responded to smile-based chemotherapy. once complete response was ascertained by pet imaging, the patient underwent myeloablative hla-matched unrelated allogeneic stem cell transplantation (cyclophosphamide 60mg/kg, total body irradiation - 12gy with anti-thymocyte globulin). the stem cell donor had a positive serology for ebv (igg). the patient's ebv titer was weakly positive at the time of transplantation. a decision was made to offer consolidative treatment consisting of donor-derived ex vivo expanded ebv-reactive t cells following transplantation. a ebv-specific t-cell line was manufactured from a portion of the cryopreserved g-csf mobilized peripheral graft after appropriate authorizations were obtained. the patient suffered a severe episode of intestinal graft-versus-host disease early following transplantation but received a first dose of ebv-reactive t cells (20x10e6 t cells/meter square of body surface area 5 months post-transplantation

Eligibility criteria:
inclusion criteria: 1. capacity to provide informed consent 2. age ≥ 18 3. negative serum pregnancy test and use of effective contraception method. exclusion criteria: 1. administration within less than 28 days of t-cell depleting antibodies (atg, okt3, campath) 2. pregnancy 3. any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient or study outcome. 4. active uncontrolled gvhd (acute gvhd grade ii-iv or progressive extensive chronic gvhd) at time of enrolment or infusion.

Keywords: adoptive immunotherapy ebv systemic ebv-positive t-cell lymphoma of childhood
using cinacalcet to treat the hypophosphatemia of early kidney transplant

Conditions: Hypophosphatemia; Renal Transplant

Summary: the purpose of the study is to determine whether cinacalcet, used in patients with secondary hyperparathyroidism to control excessive parathyroid hormone, can normalize low blood phosphorus that is commonly seen in patients who have had a kidney transplant.

secondary hyperparathyroidism (shpt), common in esrd, persists following renal transplantation resulting in profound hypophosphatemia. this can lead to hemolysis, congestive heart failure, rhabdomyolysis. phosphate repletion is difficult in view of the persistent shpt: oral phosphate supplementation can lead to hypocalcemia, reduced 1,25-oh vitamin d production, hypercalcemia and further hyperparathyroidism. in addition, phospho-soda has been associated with phosphate nephropathy and renal failure. cinacalcet hcl is a calcimimetic agent that has recently become a standard therapy in the treatment of shpt in esrd. it suppresses pth secretion by acting as a modulator of the calcium-sensing receptor on the pth cell, causing the pth cell to decrease production of parathyroid hormone. it is a very effective agent, producing significant reduction of pth as well as improvement in calcium and phosphate metabolism in the dialysis patient. the drug is well-tolerated with minimal adverse effects. cinacalcet has also been used to control hypercalcemia in renal transplant patients with persistent hyperparathyroidism. short-term cinacalcet given for 2 to 4 weeks has normalized serum phosphorus and decreased urinary phosphate wasting in renal transplant recipients with stable graft function. we hypothesize that cinacalcet hcl will normalize the hypophosphatemia of early renal transplant by reducing the effects of pth on the proximal renal tubular transport of phosphorus, thereby allowing phosphate reabsorption and decreasing urinary phosphate wasting.

Eligibility criteria:
inclusion criteria: * renal transplant within last 3 months * serum phosphorus less than 2.0 mg/dl * serum creatinine less than 2.0 mg/dl exclusion criteria: * sensitivity to cinacalcet * use of amitryptiline, desipramine, itraconazole, ketoconazole * pregnancy

Keywords: hypophosphatemia hyperparathyroidism renal transplant
high protein breakfast on weight management and glycemic control in 'breakfast-skipping' teens

Conditions: Breakfast; Appetitive Behavior

Summary: 75 overweight, habitual 'breakfast-skipping' adolescents will complete the following long-term, randomized controlled trial. participants will be randomly assigned to the following breakfast treatments: 350 kcal high protein breakfasts containing 30 g protein (primarily from lean beef), 35 g carbohydrates, and 10 g fat; 350 kcal normal protein breakfasts containing 10 g protein, 55 g carbohydrates, and 10 g fat; or will continue to skip breakfast. the following outcomes will be assessed during baseline and 4-month (post-intervention): body weight \& body composition; waist circumference; daily food intake; 24-h free-living glycemic control; and pre and post-prandial satiety. in addition, body weight and free-living breakfast intake (quantity, quality, and type) will also be assessed at 2-month follow-up

the np and hp groups will be provided with their respective breakfast meals to consume, at home, between 6:00-8:00 am each day over the 4-mo intervention. the energy content of the np and hp breakfast meals will be standardized to 350 kcal. the energy content of the breakfast meals is \~18% of daily energy intake estimated from the energy expenditure equations specific for adolescents ages 13-16 y. the np breakfasts will be 11% protein (10 g protein), 63% cho, and 26% fat, whereas the hp breakfasts will be 34% protein (30 g protein), 40% cho, and 26% fat. the types of protein incorporated within the np and hp meals will include a combination of beef (40%), dairy (20%), eggs (20%), and plant-based (20%) proteins. the np and hp meals will include the same types of breakfasts but will vary in protein and cho content. an 8-d breakfast rotation will occur throughout the study.

Eligibility criteria:
inclusion criteria: 1. males and females 2. all ethnicities 3. age: 15-21y 4. bmi/bmi percentile: 20-34.0 kg/m2 5. never smoked or used other tobacco products 6. willing to consume the study breakfasts 7. generally healthy (as assessed by medical history questionnaire) exclusion criteria: 1. clinically diagnosed with an eating disorder 2. metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite 3. currently or previously on a weight loss or other special diet (in the past 6 months) 4. gained/lost ≥4.5kg over the past 6 months 5. taking medication that would directly influence appetite (weight-loss drugs or antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months)
association between the tdcs and fds for gait rehabilitation after stroke

Conditions: Stroke

Summary: the aim of this study is to verify the effectiveness of tdcs combined with foot drop stimulation (fds) on gait rehabilitation of post-stroke subjects with mild and moderate compromise.


Eligibility criteria:
inclusion criteria: * subjects with ischemic or hemorrhagic stroke diagnosis. * mild, moderate or severe hemiparesis (chronic stroke - at least 6 months) * minimal cognitive ability to understand commands * able to walk 10 meters unassisted or with minimal assistance exclusion criteria: * no current use of antiepileptic drugs for seizures * secondary musculoskeletal disorder involving the lower limb * contraindication for electrical stimulation

Keywords: cerebrovascular accident cerebrovascular stroke cerebral stroke
measurement of gastric secretion by mri under inhibition by protonpump inhibitors in healthy subjects & in gerd patients

Conditions: Gastroesophageal Reflux Disease; Healthy Volunteers

Summary: this study bases on the successfully completed project snf 320000-112006 (ek 1152 and swissmedic 2005dr2207e) and will document the physiological effects of inhibited gastric secretion on the volume as well as the acidity of gastric secretion by high dose proton pump inhibitors in gerd patients and healthy controls. twelve participants in each group will be studied in a randomized, double-blind placebo controlled trial. a novel non-invasive mri technique developed in zurich will assess the volume of gastric secretion following the ingestion of a regular liquid meal. in addition, intragastric / esophageal ph monitoring will assess the link between volume and intragastric distribution of gastric secretion on reflux events and symptoms. in addition, the effect of gastric secretion on outcome parameters of a non-invasive stable isotope breath test for measurement of gastric emptying will be assessed.


Eligibility criteria:
inclusion criteria: - healthy volunteers must have less than one episode of reflux or dyspeptic symptoms per month of no more than mild severity in the last 3 months - reflux patients (gerd) must have chronic symptoms (\>8 weeks) suggestive for gerd (definition and questionnaire see appendix page 30). in addition, the initial screening manometry must show no severe esophageal dysmotility (e.g. spasm, achalasia). if in addition a ph-study has been performed the acid exposure must be \> 4.2% / 24h. exclusion criteria: - age under 18 or above 65 * pathologic underweight or overweight (bmi \ 30 kg/m2) * previous history of gastrointestinal disease or surgery (excludes appendectomy, cholecystectomy, hernia repair and anorectal disorders) * previous cardiorespiratory (excludes arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disease, diabetes, drug or alcohol abuse * patient unable to stop medication that alters gut function for 72 hours prior to the study, including anticholinergics, prokinetics, proton-pump inhibitors, non-steroidal anti-inflammatory drugs * positive helicobacter pylori status on 13c-urea breath test * presence of metallic implants, devices or metallic foreign bodies * pregnancy and lactation (female patients of child bearing age will receive a pregnancy test prior to study) * female volunteers without adequate contraception for the duration of the study * involvement in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
evaluation of tetrix cream in the healing of injured skin in subjects with contact dermatitis

Conditions: Healthy

Summary: to determine if tetrix cream,, when applied to the skin lesions on patients with contact dermatitis, slows or interferes with the healing of the lesions.


Eligibility criteria:
inclusion criteria: * normal subjects with sensitivity to nickel. exclusion criteria: * under 18 years of age.

Keywords: tetrix cream antigen reaction effect on healing to determine if application of tetrix cream to lesions of contact dermatitis interferes with their rate of healing
cardiovascular response to maternal hyperoxygenation in fetal congenital heart disease

Conditions: Hypoplastic Left Heart Syndrome; Aortic Coarctation; Atrial Septal Aneurysm

Summary: cardiovascular response to maternal hyperoxygenation in fetal congenital heart disease

the purpose of this study is to investigate the phenomenon of cardiovascular system response to maternal hyperoxygenation in the fetus with congenital heart disease(chd), which can provide further insight into fetal adaptations to chd and improve our understanding of the pathophysiology of these conditions.cases are gravidas with fetal congenital heart disease diagnosed by echocardiography various gestational weeks.the baseline fetal echocardiography parameters has obtained from these gravidas.then the participants received 10-15 minutes hyperoxygenation, and the accordingly fetal echocardiography parameters were obtained.the objective of the study includes:(1)to investigate the response of the mca pi to maternal hyperoxygenation in various forms of chd. middle cerebral artery(mca) pulsatility index (pi) at mh will be compared to baseline at various gestational ages in a variety of types of chd;(2)to investigate the response of the umbilical artery (ua) pi to maternal hyperoxygenation in various forms of chd. ua pi at mh will be compared to baseline at various gestational ages in a variety of chd; (3)to study the response of myocardial diastolic function to mh in various forms of chd. diastolic inflow patterns across the tricuspid and mitral valves will be measured and ductus venosus flow pattern will be evaluated at mh and compared to baseline at various gestational ages in a variety of chd;(4)to investigate for any changes in cardiac output and the ratio of flow between the right and left ventricles in response to mh in various forms of chd;(5)to investigate for changes in flow pattern at the aortic isthmus in those with suspicion or clear evidence of coarctation of the aorta.

Eligibility criteria:
inclusion criteria: * all singleton fetuses with chd at all gestational ages are eligible for enrollment in the study. patients will be recruited to enroll in the study as they present for clinical care at fetal echocardiography clinic. mh assessments will all be performed only at the beijing anzhen hospital. baseline room air data for chd may be collected from other referring centers within the anzhen network. exclusion criteria: * non-sinus rhythm, presence of arrhythmia; fetal hydrops; severe brain anomaly (which may influence mca flow); evidence for significant ventricular dysfunction; evidence for constriction of the ductus arteriosus

Keywords: echocardiography congenital heart disease maternal hyperoxygenation
post-marketing surveillance of lenvatinib mesylate (lenvima capsule) in patients with unresectable thyroid cancer (study len01t)

Conditions: Thyroid Neoplasms

Summary: this study is a post-marketing surveillance of lenvatinib in participants with unresectable thyroid cancer. the objectives of this study are to capture unknown adverse reactions, incidences of adverse drug reaction, efficacy, factors considered to have effect to safety and effectiveness, and incidences of hypertension, hemorrhagic events and thromboembolic event, and liver disorder.


Eligibility criteria:
inclusion criteria: 1. all participants with unresectable thyroid cancer and administrated lenvatinib.

Keywords: thyroid cancer lenvima post-marketing surveillance len01t all-patient investigation lenvatinib mesylate
myocardial protection of exenatide in ami

Conditions: Myocardial Infarction

Summary: experimental evidence suggests exenatide, a glucagon-like peptide 1 receptor analogue, has significant cardiovascular protective effects in various conditions. the investigators examined whether conventional use of exenatide at the time of primary percutaneous coronary intervention would reduce the infarct size in patients with st-segment elevation myocardial infarction (stemi).

in this proof-of-concept trial, we assessed the effects of acute-phase adjunctive exenatide therapy in patients with stemi. infarct size after stemi was evaluated by both cardiac magnetic resonance image and cardiac biomarkers compared with standard treatment. lv function was assessed by conventional and speckle tracking echocardiography. during 6-month follow up, the safety/tolerability of exenatide and clinical outcomes were also assessed.

Eligibility criteria:
inclusion criteria: * age between 20 and 79 years * patients presenting with first st-segment elevation myocardial infarction * thrombolysis in myocardial infarction \[timi\] flow grade 0) exclusion criteria: * cardiac arrest * ventricular fibrillation * cardiogenic shock * hemodynamic instability * suspicious stent thrombosis * left bundle branch block * previous acute myocardial infarction * previous coronary artery bypass operation * significant valvular heart disease * primary myocardial disease * atrial fibrillation * significant hepatic or renal dysfunction, hypoglycaemia, * diabetic ketoacidosis * active infection or chronic inflammatory disease * malignancy * women who were pregnant or who were of childbearing age

Keywords: myocardial infarction percutaneous coronary intervention exenatide reperfusion injury cardiac magnetic resonance