Kornimate/medical-research-clean huggingface dataset:
prophylactic antibiotics for urinary tract infections after robot-assisted radical cystectomy

Conditions: Bladder Carcinoma; Refractory Bladder Carcinoma; Urinary Tract Infection

Summary: this trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). urinary tract infections are a common occurrence after robot-assisted radical cystectomy. antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.

primary objective: i. to determine if the utilization of a prophylactic antibiotic during the postoperative period will decrease the rate of urinary tract infection (uti) post robot-assisted radical cystectomy. secondary objective: i. to identify pre- and post-operative factors that may be associated with the development of a 90-day uti following radical cystectomy. outline: patients are randomized to 1 of 2 groups. group i (antibiotic): patients receive ertapenem intravenously (iv), levofloxacin, or clindamycin iv at induction per standard of care. at the time of full diet, patients receive trimethoprim-sulfamethoxazole po daily or nitrofurantoin po daily on days 1-30. patients complete a drug diary for each day they receive the antibiotic. group ii (control): patients receive ertapenem iv, levofloxacin iv or clindamycin iv at induction per standard of care. after surgery, patients are followed up to 120 days.

Eligibility criteria:
inclusion criteria: * any patient that electively chooses to have a cystectomy is eligible to participate in the study. indications for a person who may undergo a cystectomy include having a diagnosis of muscle-invasive bladder cancer (mibc) or refractory non-muscle invasive bladder cancer (nmibc) * any patient that will electively choose to have a robot-assisted radical cystectomy and is able to provide consent * participant or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure exclusion criteria: * patients with a history of myasthenia gravis * patients with a history of qt prolongation or taking other drugs that prolong corrected qtc (qtc) should be excluded * patients with renal dysfunction, creatinine clearance (ml/min) \< 30 * pregnant or nursing female participants * females who receive a fertile sex sparing robot-assisted radical cystectomy (rarc) * unwilling or unable to follow protocol requirements * patients who receive a prophylactic antibiotic or antibiotic for any other reason prior to discharge * any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
a study to evaluate awareness and knowledge of the fibristal additional risk minimization measures among patients in canada

Conditions: Uterine Fibroids

Summary: this is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the additional risk minimization measures for fibristal among patients in canada.

data will be collected via web-based data capture and paper surveys depending on patient preference. the survey will be conducted in a single wave over 6 months. all data will be maintained in compliance with local regulations.

Eligibility criteria:
inclusion criteria: * patients who have received fibristal within 6 months of completing the survey. * patients who have provided permission to share their responses in aggregate with health canada. * patients who have provided informed consent for their participation in the survey. exclusion criteria: * patients who participated in the cognitive pre-testing of the survey questionnaire to be used for the study. * patients who have been direct employees of allergan, icon, health canada, or professional targeted marketing (ptm) within the past year.
physical activity interventions for leg ulcer patients

Conditions: Leg Ulcers; Venous Ulcers; Varicose Ulcers

Summary: the goal of this study is to test footfit and enhanced footfit+, home-based mobile health (mhealth) physical activity (pa) interventions for a minimally ambulatory, chronically-ill, population with leg ulcers. a highly sensitive clinically designed bluetooth® enabled accelerometer and tracking device (beat) worn on the foot during a progressive and evidence-based non-exertive leg conditioning activities for lower leg function (calf) captures minute foot movements and sends the data to a smartphone. this six-week feasibility study will compare footfit to footfit+, with the added connectivity feature, to promote patient-provider communication, evaluate adherence to pa, and assess signals of efficacy on functional outcomes in a very low fitness population.

footfit is a study of a lower leg conditioning mhealth intervention for patients with venous leg ulcers. the aims are to compare two versions, one of which is enhanced (footfit+), to determine which has the greatest impact on physical activity adherence, patient-provider communication, and leg function. footfit and footfit+ share three components: 1) a low-cost, tri-axial bluetooth® enabled highly sensitive accelerometer and tracking device (beat) worn on the foot during, 2) phased conditioning activities for lower leg function (calf) tracked by a, 3) smartphone that captures signals from beat, provides motivational messages, calf instruction, and automated feedback on progress. forty patients will be targeted in this six-week study, 20 of which will receive footfit and 20 footfit+.

Eligibility criteria:
inclusion criteria: * active venous leg ulcer * ankle brachial index 0.80 to 1.3 mmhg, a measure of arterial sufficiency * sedentary-able to only walk a few steps at a time or not farther than 10 feet * not currently exercising or participate in a pa or physical therapy program * receives at least weekly wound care anticipated to last for at least six weeks from start of study * able to don accelerometer - if unable to apply independently, has assistance from other * capable of using smartphone exclusion criteria: * co-morbid conditions such as stroke (limits ankle function) * ulcer from other causes (arterial, diabetic, trauma, surgery) * documented cognitive impairment (minicog) * no 3g service in area where patient resides
exercise & overweight children's cognition

Conditions: Overweight and Obesity

Summary: this research focuses on overweight, sedentary children whose health, cognition, and academic performance are therefore at risk, and who may be particularly responsive to exercise interventions. this study will determine whether regular exercise per se (i.e. compared to attention control, or placebo, condition) benefits children's cognition and achievement, and will provide insight into neural mechanisms. a substudy will examine exercise-induced changes in brain structure. provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic by persuading policymakers, schools and communities that time spent in physical activity enhances, rather than detracts from, learning.

an ancillary study adding cardiometabolic outcome measures was added (r01hl087923-02s1, http://projectreporter.nih.gov/project_info_description.cfm?aid=7880457\&icde=20104167)

Eligibility criteria:
inclusion criteria: * 8-11 years of age * overweight or obese (bmi-for-age \>= 85th percentile) * able to participate in exercise testing and intervention exclusion criteria: * medical condition or medications that would interfere with measurements * participation in weight control or formal exercise program outside physical education that meets more than 1 day/week * t-score \> 75 on the brief behavior regulation scale to avoid program disruption
phase 1 study evaluating the safety and pk of adu-1805 in advanced solid tumors

Conditions: Solid Tumor, Adult; Metastatic Solid Tumor; Refractory Cancer

Summary: this first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to evaluate the safety, pk, and pd of adu-1805, an anti- sirpα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-pd-1 antibody).

the study will start with the adu-1805 monotherapy dose escalation arm following an i3+3 design until the rp2d is defined. the adu-1805 plus pembrolizumab dose escalation arm, also following an i3+3 design, will start after clearance of the adu-1805 monotherapy dose level achieving maximum target engagement (e.g. ≥ 90% target engagement) and will continue until the rp2d for the combination is defined.

Eligibility criteria:
inclusion criteria: * male or female aged ≥18 years * signed and dated informed consent form * histologically and/or cytologically confirmed diagnosis of metastatic or unresectable solid tumors that are refractory to standard therapy or for which no standard therapy exists * measurable disease according to recist (safety expansion only) * ecog performance status of 0 or 1 * adequate organ and marrow function exclusion criteria: * patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (pdac) * pregnancy or breast-feeding * prior treatment with or receipt of: * biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of adu-1805 * chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of adu-1805 and within 42 days for nitrosoureas and mitomycin c. * anti-sirpα or anti-cd47-directed therapy * systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of adu-1805 * other investigational new drug or investigational device within 28 days prior to the first dose of adu-1805 * vaccine containing live virus within 28 prior to the first dose of adu-1805 * active untreated brain metastases * active infection requiring systemic therapy * impaired cardiac function or clinically significant cardiac disease * current grade \>2 toxicity related to prior anti-cancer therapy * history of drug-induced severe immune-related adverse reaction * prior severe hypersensitivity to other monoclonal antibodies or adu-1805 excipients * major surgery within defined period * diagnosis or positive test of hiv, hepatitis b, hepatitis c, or active tuberculosis * allogenic tissue/solid organ transplant * any intercurrent illness that is life-threatening or of such clinical significance that it would interfere with the patient's safety or ability to participate in the study

Keywords: immunotherapy
a randomized trial of base-in prism reading glasses convergence insufficiency in children

Conditions: Convergence Insufficiency

Summary: this study is designed to compare the use of special prism glasses to placebo treatment for children with symptomatic convergence insufficiency.

the base-in for convergence insufficiency treatment trial (bi-citt) is a multi-center, placebo-controlled, masked, clinical trial designed to compare the benefits of base-in prism for patients with convergence insufficiency (ci). the goals of this clinical trial are: * to compare the effectiveness of base-in prism and placebo eyeglasses for the treatment of ci in children * to study the long-term effect of these treatments for ci * to identify factors that may be associated with successful treatment of ci with base-in prism

Eligibility criteria:
inclusion criteria: * age: 9 to \<19 years. * best corrected visual acuity of ≥20/25 in each eye at distance and near * willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary * willingness to wear glasses for reading and other near work * exophoria at near at least 4 greater than at far * insufficient positive fusional convergence (fails sheard's criterion) * receded near point of convergence of  6 cm break * random dot stereopsis appreciation using a 500 seconds of arc target. * ci symptom survey score  16 exclusion criteria: * amblyopia (\> 2 line difference in best corrected visual acuity between the two eyes). * constant strabismus * history of strabismus surgery. * anisometropia  2d in any meridian between the eyes. * prior refractive surgery. * vertical heterophoria greater than 1 . * systemic diseases known to affect accommodation, vergence and ocular motility such as: multiple sclerosis, graves thyroid disease, myasthenia gravis, diabetes, parkinson disease. * any ocular or systemic medication known to affect accommodation or vergence (anti-anxiety agents (librium or valium), anti-arrhythmic agents (cifenline or cibenzoline), anticholinergics (motion sickness patch (scopolamine), bladder spasmolytic drugs (propiverine), chloroquine, phenothiazines (compazine, mellaril, or thorazine), tricyclic antidepressants (elavil, nortriptyline, or tofranil) * accommodative amplitude \<5 d in either eye as measured by the donder's push-up method. * manifest or latent nystagmus. * developmental disability, mental retardation, attention deficit hyperactivity disorder (adhd), or learning disability diagnosis in children that in the investigator's discretion would interfere with treatment. * household member or sibling already enrolled in the bi-citt. * any eye care professional, ophthalmic technician, ophthalmology or optometry resident or optometry student.

Keywords: convergence insufficiency base-in prism orthoptics vision therapy
assessment of dose-dependent immunomodulatory effect of alveofact with or without steroisd in neonatal rds

Conditions: Neonatal Respiratory Distress Syndrome; Inflammatory Response; Premature Lungs; Neutrophil Extracellular Trap Formation; Preterm Birth

Summary: an exploratory randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of alveofact with or without budesonide.

neonatal respiratory distress syndrome (rds) is caused by lung immaturity and surfactant deficiency in preterm newborns and is an important cause of morbidity and mortality. surfactant therapy plays an essential role in the management of rds as it reduces lung injury and improves survival, while surfactant alone is very effective, some studies showed that its combination with budesonide significantly reduces bpd and inflammatory markers. neutrophils extracellular traps (nets) are a defense mechanism where neutrophils are the reaction to microbial infection and cast a net-like structure. nets are composed of chromatin decondensed and some 30 enzymes and peptides. many components such as neutrophil elastase (ne) and myeloperoxidase enzyme (mpo) have antimicrobial, but also a cytotoxic property that causes tissue injury. the immune regulatory abilities of the pulmonary surfactant are known to alter the function of the adaptive and innate immune cells. so, in this study, the investigator will assess the immunomodulatory effect of low and high doses of alveofact with or without budesonide.

Eligibility criteria:
inclusion criteria: * gestational age ≤ 35 weeks with 1. respiratory distress syndrome. 2. need surfactant administration based on european rds consensus: (sweet et al., 2019) 3. if intubation is required as part of stabilization. 4. clinically presenting with increased work of breathing including (tachypnea, nasal flaring, grunting, retractions, and cyanosis, with decreased air entry on auscultation. 5. babies who are worsening when fio2 \>0.30 on cpap pressure of at least 6 cm h2o to maintain normal saturations. exclusion criteria: preterm neonates with evidence of any of the following will be excluded: 1. chromosomal anomaly or congenital heart defect 2. hemodynamically significant patent ductus arteriosus. 3. early-onset sepsis or bacterial infection 4. congenital pneumonia 5. intra ventricular hemorrhage (ivh) 6. parenteral refusal to participate.
catch me if you can - the individual relationship between potential ablation targets from cartofinder and myocardial fibrosis

Conditions: Atrial Fibrillation

Summary: single center observational study to compare the relationship between atrial fibrosis and potential ablation targets from cartofinder.

a total number of 30 patients will undergo catheter ablation for persistent af. pre-procedural cardiac mri will be performed with late-gadolinium enhancement to visualize the individual amount and distribution of fibrosis in the right and left atrium. cartofinder-guided mapping will be performed during the ablation procedure followed by af ablation. the individual relationship between atrial fibrosis and potential ablation targets will be accessed.

Eligibility criteria:
inclusion criteria: 1. patients undergoing their 1st af ablation procedure for persistent atrial fibrillation (af) as per recent heart rhythm society (hrs) consensus document 2. able to understand and willing to sign the informed consent form. 3. age ≥18 years. exclusion criteria: 1. contraindication for de-mri with a full dose of gadolinium-based contrast agent. 2. previous left atrial ablation or surgical procedure 3. renal failure with crcl \<60 ml/min 4. women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to use a reliable form of contraception 5. mental or physical inability to take part in the study 6. uncontrolled hypertension 7. morbid obesity (bmi \> 35), or inability to be placed in mri due to body mass.
hcv-smoking cessation study

Conditions: Hepatitis C; Smoking Cessation

Summary: a 12-week study for patients who are being treated for hepatitis c and would like to quit smoking. during the 12 weeks of hepatitis c treatment, the research team will have counseling sessions with the participants to discuss challenges related to hepatitis c and smoking.

a 12-week smoking cessation intervention addressing concurrently hcv and smoking cessation the standard of care for hcv is 12 weeks of oral medication with 3 in-person provider/laboratory visits throughout. this study utilizes both in-person and phone counseling and health education sessions. each session will address a different topic related to hcv, smoking, and how both smoking and hcv affect health and quality of life.

Eligibility criteria:
inclusion criteria: * adults (≥18 years old) * current hcv infection (hcv rna+) * current cigarette smoking * patients in contemplation / preparation stage of change exclusion criteria: * inability to speak/read english, as materials will be provided in english * current suicidal ideation as determined by the phq-9, requiring a greater level of clinical care * severe medical or psychiatric disability that prevents participant from ability to comprehend or consent to study
jskn033 in chinese subjects with advanced malignant tumors

Conditions: Advanced Malignant Tumors

Summary: this is a phase i/ii multicenter study to evaluate the safety and efficacy of jskn033 in chinese subjects with unresectable locally advanced/metastatic solid tumors.


Eligibility criteria:
inclusion criteria: 1. be able to understand informed consent form, voluntarily participate and sign informed consent form. 2. age ≥18 year (at the time consent is obtained), male or female. 3. has an eastern cooperative oncology group (ecog) performance status of 0-1. 4. has a life expectancy ≥3 months. 5. has a pathologically documented advanced/unresectable or metastatic solid malignant tumor that is refractory to or intolerable with standard treatment. 6. has at least 1 measurable lesion at baseline according to recist 1.1 criteria. 7. must have adequate organ function prior to the start of jskn033. 8. negative urine/serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. exclusion criteria: 1. has clinically active brain metastases. 2. previously received any other investigational drug within 28 days prior to enrollment. 3. previously received local palliative treatment within 14 days prior to enrollment. 4. previously received major surgeries within 28 days prior to enrollment. 5. need to receive continuous administration of corticosteroids or immunosuppressants for 7 days within 14 days prior to enrollment. 6. previously received live vaccine within 28 days prior to enrollment. 7. previously received antibody conjugate drug with topoisomerase i inhibitor. 8. has a history of other primary malignant tumors within 5 years prior to enrollment. 9. has uncontrolled comorbidities as specified by the protocol. 10. has a history of interstitial pneumonia/lung disease requiring systemic hormonal therapy, or suspected interstitial pneumonia/lung disease that cannot be ruled out by imaging during screening period. 11. subjects with uncontrolled large serous cavity effusion or moderate to large serous cavity effusion requiring repeated drainage (recurrent within 2 weeks after intervention) such as pleural effusion, pericardial effusion, ascites, etc. 12. toxicities of previous antitumor therapy did not resolve to grade 1 defined by ctcae v5.0. 13. has a history of life-threatening anaphylaxis or known hypersensitivity to any component or excipient to the study drug. 14. has a history of allogeneic bone marrow or organ transplantation. 15. pregnant or breastfeeding female patients. 16. other conditions that the investigator considers unsuitable to participate in this clinical trial, including but not limited to psychiatric disorders, alcoholism or drug abuse, etc.
effect of a tracking program on colon adenoma surveillance and adherence to guideline recommendations

Conditions: Colon Polyp Surveillance

Summary: this will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were found to have a tubular adenoma between the years of 2004-2008. we will compare the rate and timing of completion of repeat colonoscopies pre and post establishment of a polyp registry (tracking system) in 2006. each group will be composed of up to 500 subjects consecutively identified from all the patients who underwent colonoscopy and were found to have a tubular adenoma (group 1-2004 to 2006, group 2 2007-2008).

this will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were found to have a tubular adenoma between the years of 2004-2008. we will compare the rate and timing of completion of repeat colonoscopies pre and post establishment of a polyp registry (tracking system) in 2006. each group will be composed of 380-500 subjects consecutively identified from all the patients who underwent colonoscopy and were found to have a tubular adenoma (group 1-2004 to 2006, group 2 2007-2008).

Eligibility criteria:
inclusion criteria: * any adenoma found on screening/surveillance colonoscopy (icd9-211.3, procedure code 45385 or 45380) * greater than 18 years old exclusion criteria: * less than 18 years old * diagnosis of ibd

Keywords: polyp colonoscopy surveillance
campania puglia branch iliaco

Conditions: Aortoiliac Aneurysm; Iliac Aneurysm

Summary: spontaneus multicentric observational registry to investigate the medium and long-term performances of the iliac e-liac branch device from artivion for treatment of aortoiliac aneurysms in a real-world consecutive patients cohort.


Eligibility criteria:
inclusion criteria: * an aortoiliac or aortic aneurysm of surgical interest based on the most recent local guidelines treated with the e-liac stent-graft system, alone or in combination with other devices exclusion criteria: * patient's refusal to be enrolled in the registry * patient treated with devices not including the e-liac stent-graft system

Keywords: evar bevar aaa