Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of once-daily ciprodexa otic foam compared to twice-daily ciprodex ear drops in acute otitis externa

Conditions: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis

Summary: the purpose of this study is to assess the safety and efficacy of ciprodexa foam (0.3% ciprofloxacin, 0.1% dexamethasone otic foam), used once-a-day for 7 days for the treatment of acute diffuse otitis externa, compared to ciprodex otic suspension used twice daily for 7 days.

acute otitis externa (aoe) is defined as a diffuse inflammation of the external ear canal, which may also involve the pinna and/or the tympanic membrane. aoe is one of the most common infections encountered by otolaryngologists, pediatricians and family physicians. diagnosis of aoe requires rapid onset (generally within 48 hours) of symptoms and signs of ear canal inflammation which includes: a) otalgia (often severe), itching or fullness, sometimes accompanied by reduced hearing or jaw pain; b) tenderness of the tragus and/or pinna; and c) diffuse ear canal edema with or without erythema, sometimes accompanied by ear discharge (otorrhea).

Eligibility criteria:
inclusion criteria: * aged 3 years to 80 years old. * have a clinical diagnosis of acute otitis externa based on clinical observation and of presumed bacterial origin. * intact tympanic membrane * unilateral disease exclusion criteria: * known allergy or sensitivity to ciprofloxacin or other quinolones. * clinical diagnosis of chronic suppurative otitis media (csom), acute otitis media (aom), involvement of middle ear effusion (mee). * patient has the non intact tympanic membrane. * patient has a serious underlying disease. * patients with known history of immune dysfunction/deficiency and those receiving immunosuppressive therapy. * patients with history of diabetes mellitus. * patients with more than 80% of the ear canal occluded. * pregnant or lactating patients. * overt fungal acute otitis externa. * local ear canal abnormalities such as abscess, granulation or polyps. * congenital abnormalities of the external auditory canal or obstructive bony exostosis in the treated ear. * mastoid or other suppurative non-infectious ear disorder (e.g. cholesteatoma) in the treated ear. * seborrheic dermatitis or other dermatological conditions of the external auditory canal which would complicate evaluation. * current infection requiring systemic antimicrobial therapy. * current or previous use of topical or oral antibiotics (within 3 days) or long-acting antibiotics (within 7 days). * current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.

Keywords: swimmer's ear ear drops ear foam otic foam ear infection ear pain ear inflammation
incidence of headache following an unintentional dural puncture

Conditions: Postdural Puncture Headache; Post-Lumbar Puncture Headache; Cerebrospinal Fluid Leaks

Summary: the purpose of this study is to evaluate the use of intrathecal morphine administration following an unintentional dural puncture, to decrease the incidence of post dural puncture headaches (pdph) in obstetric patients.

unintentional dural puncture is a known risk of neuraxial techniques, occurring in roughly 1% of all epidural catheter placements. the incidence of post dural puncture headaches(pdph) after unintentional dural puncture (udp) is 50-80%. a pdph is defined as a headache that occurs following a dural puncture, worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying, with at least one of the following: neck stiffness, tinnitus, hypacusia, photophobia, or nausea. the headache develops within 5 days after dural puncture and resolves either spontaneously within 1 week or within 48 hours after effective treatment of the spinal fluid leak. the rates of pdph following unintentional dural puncture with placement of an intrathecal catheter will be compared in two groups: intrathecal morphine (treatment) versus intrathecal saline (control) administered 1-2 hours after delivery, followed by immediate catheter removal. patients randomized to the treatment group (morphine) will receive preservative-free morphine 0.3 ml (150 mcg) intrathecally. those randomized to the control group will receive normal saline 0.3 ml intrathecally. after administration of intrathecal morphine, all patients will have their respirations monitored every hour for a period of 12 hours and then every two hours for a period of 12 hours. on postpartum days 1-5, all patients will be visited daily while inpatient and/or contacted by phone after discharge from the hospital. pdph can lead to significant morbidity and negatively impact patient satisfaction with postpartum recovery. along with headache, patients may develop cranial nerve palsy during the postpartum period leading to permanent disability. in addition, new mothers are unable to bond with their babies due to headache and associated symptoms of nausea, vomiting and limited mobility secondary to pain. therefore, an effective intervention to decrease the risk of pdph after udp would be useful.

Eligibility criteria:
inclusion criteria: * postpartum patients following vaginal delivery * unintentional dural puncture * functioning intrathecal catheter * patients must be 18 years of age or older * english speaking. exclusion criteria: * history of previous pdph * body mass index bmi \> 40 kg/m2 * history of obstructive sleep apnea (osa) * morphine allergy * patients who receive cesarean delivery

Keywords: postdural puncture headache intrathecal morphine intrathecal catheter headache labor and delivery unintentional dural puncture
a randomized study of gemtuzumab ozogamicin (go) with daunorubicine and cytarabine in untreated acute myeloid leukemia (aml) aged of 50-70 years old

Conditions: Acute Myeloid Leukemia

Summary: the main objective of this study is to compare conventional chemotherapy: daunorubicin and the aracytine and this chemotherapy in combination with the monoclonal antibody used mylotarg in divided doses.

patients with a morphologically proven diagnosis aml and both the two following criteria: * age \> 50 years and £ 70 years. * not previously treated for their disease. randomization will be centralized by phone : arm a chemotherapy with daunorubicin and aracytine or arm b daunorubicin and aracytine and mylotarg.

Eligibility criteria:
inclusion criteria: * patients with a morphologically proven diagnosis aml and both the two following criteria: age \> 50 years and £ 70 years. not previously treated for their disease. * ecog performance status 0 to 3 * negative serology hiv, hbv and hbc (except post vaccination) * serum creatinin inf 2.5n; ast and alt inf 2.5n; total bilirubin inf 2n * cardiac function determined by radionucleide or echography within normal limits. * negative serum pregnancy test within one week before treatment for women of child bearing potential. * signed informed consent. exclusion criteria: * m3-aml * aml following previously know myeloproliferative syndrome. * known central nervous system involvement. * uncontrolled infection * other active malignancy

Keywords: acute myeloid leukemia patient aged 50 to 70 years
fdg pet/ct in lung cancer staging

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Summary: prospective study of the effects of image acquisition and reconstruction parameters on accuracy of fdg pet/ct mediastinal nodal staging in nsclc


Eligibility criteria:
inclusion criteria: * adult patients, at least 18 years of age * patients with nsclc diagnosis who have been referred for a clinical fdg pet/ct staging scan as part of their standard of care * participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. exclusion criteria: * inability to tolerate additional imaging time in the opinion of the investigator or treating physician. * only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. individuals who are considered to be mentally disabled will not be recruited for this study. all subjects must be able to give informed consent. we will not be using specific methods to assess decisional capacity. economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation and there is no additional cost associated with the additional study imaging time. all individuals will be told that their choice regarding study participation will in no way change their access to clinical care or their ability to undergo the standard clinical fdg pet/ct scan. this should negate any undue influence or coercion. children, fetuses, neonates, or prisoners are not included in this research study
study to evaluate safety, efficacy of pbi-4050 & its effect on relevant biomarkers in t2dm patients with metabolic syndrome

Conditions: Type 2 Diabetes Mellitus; Metabolic Syndrome

Summary: this is a phase 2, multi-center, double-blind, placebo-controlled study of the safety and effect of pbi-4050 at doses ranging from 400 mg to 1200 mg on relevant biomarkers in subjects with inadequately-controlled t2dms on stable background antidiabetic therapy.

this phase 2 study will be performed by 15 sites in canada. the total duration of study participation for each subject is approximately 20 weeks and comprises 6 study visits a total of approximately 268 subjects will be enrolled in the study and randomly assigned to one of the following 4 treatment groups: * pbi-4050 400 mg * pbi-4050 800 mg * pbi-4050 1200 mg * placebo all subjects will receive the assigned study drug for 12 weeks.

Eligibility criteria:
inclusion criteria: 1. subject is 18 years of age or older. 2. subject has signed written informed consent. 3. subject has a clinical diagnosis of t2dm with an hba1c level between ≥ 7.5% and ≤ 10%. 4. subject has been receiving stable antidiabetic therapy (with or without basal insulin) for a minimum of 3 months before the screening visit. 5. subject is able and willing to self-monitor blood glucose level at home. 6. subject has a body mass index (bmi) of ≥ 27 kg/m2 and ≤ 45 kg/m2. 7. subject has metabolic syndrome, having at least 3 of the 5 risk factors. exclusion criteria: 1. subject is using prandial insulin or pre-mixed insulin in addition to oral hypoglycaemic agents for blood glucose control. 2. subject is taking basal insulin dose \> 1.0 u/kg/day. 3. subject has recent or on-going infection requiring systemic treatment with an anti-infective agent within 30 days before screening. 4. subject has a history of pancreatitis or diabetic ketoacidosis. 5. subject has had at least one episode of severe hypoglycaemia in the past 12 months. 6. subject has evidence of significant cardiovascular disease within 3 months before screening. 7. subject has an estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73 m2. 8. subject has uncontrolled hypertension. 9. subject has a diagnosis of rheumatic or inflammatory disease; or other autoimmune or inflammatory disease. 10. subject is concurrently taking and plans to routinely continue taking anti-inflammatory medications during the study. 11. subject is currently using medications for the indication of (or at the doses indicated for) weight loss. 12. subject has significantly elevated liver enzyme levels. 13. history of malignancy of any organ system, treated or untreated, within the past 5 years other than basal or squamous cell skin cancer. 14. subject has a history of chronic alcohol or other substance abuse. 15. subject has a history of an allergic reaction to pbi-4050 or any of its excipients.
right apical versus septal pacing trial

Conditions: Heart Block; Heart Failure

Summary: the purpose of this study is to examine whether rv (right ventricular)septal pacing has any effect on lv ( left ventricular) function than rv apical pacing in patients who require ventricular pacing.

the primary objective of this study is to compare the effect of rv pacing site on lv systolic function as measured by lvef (left ventricular ejection fraction). secondary objectives of this trial include: 1. to compare the effect of rvseptal(rvs) versus rvapical(rva)pacing on other indices of systolic and diastolic lv function 2. to compare the rate of heart failure-related hospitalization between rvs versus rva pacing 3. to compare new-onset atrial fibrillation and stroke rates between rvs versus rva pacing 4. to assess the effect of rva versus rvs pacing on quality of life and functional capacity 5. to compare the rate of successful pacemaker lead implantation, complications and chronic electrical performance of rvs versus rva pacing

Eligibility criteria:
inclusion criteria: 1. a)fixed (third degree) av block b) atrial fibrillation with average ventricular rate on ecg \ /= 300msec d) paroxysmal, persistent or permanent af undergoing av node , av node/his ablation e) 2°av block with ≥3:1 block 2. the subject is 18 years of age or older 3. the subject has provided written consent - exclusion criteria: 1. pre-existing permanent cardiac pacemaker or icd (defibrillator) 2. presence of hypertrophic obstructive cardiomyopathy 3. recent cardiac surgery (\</= 30 days) 4. recent myocardial infarction (\</= 30 days) 5. presence of mechanical prosthetic tricuspid valve 6. patient inability or unwillingness to comply with study protocol and required study visit schedule 7. concomitant research study whose protocol would conflict or affect the outcome of this study 8. patient not expected to survive for the duration of the study follow-up due to co-morbid medical condition

Keywords: permanent pacemaker implantation- lead position
npwt vs primary closure in ssi prevention for emergency laparotomies for peritonitis

Conditions: Peritonitis; Surgical Site Infection; Infections; Wound Infection

Summary: the study aims to evaluate the efficacy of negative pressure wound therapy (npwt) compared with primary closure (pc) in surgical site infection (ssi) prevention for laparotomy for peritonitis.

surgical site infection is a particularly common morbidity in contaminated surgeries leading to prolonged length of hospital stay, healing time, and a significant financial burden on healthcare systems. hence, the objective of pristine trial is to compare the effectiveness of subcutaneous npwt with pc for ssi prevention in patients who, due to wound contamination, are prone to infection. moreover, with a further cost analysis, the investigators aim to evaluate the rationale for the implementation of routine preventive npwt for laparotomy for diffuse peritonitis. patients qualified for an emergency laparotomy for peritonitis in university clinical centre (ucc) division of oncological, endocrine and general surgery will be identified. prior to laparotomy, participants will be randomized in 1:1 ratio to subcutaneous npwt or pc. the assigned intervention will be performed intraoperatively, after fascia closure. all participants will receive an empirical antibiotic therapy regimen consisting of tazobactam/piperacillin or ciprofloxacin+ metronidazole. participants will be followed-up postoperatively for one year. in case of an ssi all participants, regardless of their initial allocation, will be treated according to the standard of care with prolonged npwt and targeted antibiotic therapy.

Eligibility criteria:
inclusion criteria: * qualified for an emergency laparotomy for peritonitis * gave written informed consent exclusion criteria: * qualified for open abdomen treatment

Keywords: laparotomy npwt primary closure vacuum-assisted closure vac
a clinical trial of yh23537 in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to evaluate efficacy and safety of yh23537 versus celebrex in patients with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * signed informed consent * men and women ≥ 40 years of age * patients with knee osteoarthritis at one or both knee by acr exclusion criteria: * patients with known or suspected secondary knee osteoarthritis * other exclusions applied
the effect of daily tamsulosin 0.2mg administration on renal function in patients with benign prostatic hyperplasia

Conditions: Chronic Kidney Failure; Prostatic Hyperplasia

Summary: the purpose of this study is to determine whether medical treatment for bladder outlet obstruction is effective in improvement of glomerular filtration rate and/or proteinuria.

urodynamic parameters including maximal flow rate, compliance (infused volume gradient divided by bladder pressure gradient during cystometry), maximal detrusor pressure, bladder outlet obstruction index and schäfer grade will be checked. estimated glomerular filtration rate and urinary protein to creatinine ratio will be checked. international prostate symptom score will be checked.

Eligibility criteria:
inclusion criteria: * men with low urinary tract symptoms aged between 40 and 80 * estimated glomerular filtration rate \< 60 or evidence of proteinuria * bladder outlet obstruction index \> 40, schäfer grade 2 or more, maximal flow rate lower than 10 cc/s or postvoid residual urine \> 100cc exclusion criteria: * bladder outlet obstruction index less than 40, schäfer grade 0 or 1, maximal flow rate higher than 10 ml/s and postvoid residual urine less than 100cc * want surgical procedure * evidence of prostate cancer or bladder cancer * major depressive disorder, dementia, parkinson's disease or neurological deficits * history of pelvic irradiation * uncontrolled diabetes mellitus or hypertension * symptomatic orthostatic hypotension

Keywords: urodynamics glomerular filtration rate
peripheral nerve block anaesthesia for ankle fracture surgery - an exploratory study: is rebound pain a problem?

Conditions: Postoperative Pain

Summary: the purpose of this exploratory study is to characterize the postoperative pain profile of patients undergoing operation with internal fixation of an ankle fracture under nerve block anaesthesia. special attention is payed towards the possible existence and clinical relevance of a rebound pain phenomenon upon cessation of the nerve block. results are used to guide the set up of a randomized controlled trial on the subject.

peripheral nerve blocks (pnb) are widely used as anaesthesia and postoperative pain control for surgery. several studies have suggested multiple benefits of pnb's but primarily shown in elective surgery. acute conditions like ankle fractures have a different pain profile and risks and benefits of pnb's have not been sufficiently researched in these cases. a recent study (goldstein et al. 2012) suggested that a rebound pain effect occur upon cessation of pnb effect defined as a pain increase to a significantly higher level than observed in patients with no pnb at the same point after surgery. with this prospective, exploratory study we aim to examine the postoperative pain profile after pnb anaesthesia for ankle fracture surgery with focus on plausibility of a rebound pain effect (as defined above) upon pnb cessation. secondarily to explore a variety of factors related to postoperative pain profile and feasibility of pnb anaesthesia for ankle surgery including efficacy, risk factors, time factors as well as postoperative recovery and overall patient satisfaction. results will provide focus for a following randomized controlled trial.

Eligibility criteria:
inclusion criteria: * patients \>= 18 years old scheduled for internal fixation of an ankle fracture as defined above. * ability to read and understand danish and give informed oral and written consent exclusion criteria: * multitrauma patients / other simultaneous fractures * cognitive or psychiatric dysfunction causing expected inability to comply with study protocol * "cave" nonsteroidal antiinflammatory drugs (nsaid) or morphine or local anaesthetics as evaluated by anesthesiologist for any reason * primary investigator unavailable for pnb administration at scheduled time of operation * infection at pnb injection site * time from fracture to operation \> 5 days * existing neuropathy with functional impairment of the fractured extremity * bodyweight \< 50 kg * daily use of opioids \> 2 weeks preoperatively * pregnancy * nephropathy requiring dialysis

Keywords: ankle fracture nerve block postoperative pain pain profile rebound pain
supportbp 2.0:behavioral science and enrollment in remote monitoring for hypertension management

Conditions: Hypertension

Summary: a 3-arm randomized pilot trial aimed at comparing the effectiveness of different approaches to recruiting patients to participate in a 6-month remote monitoring program for the management of hypertension (htn).

the investigators will utilize the way to health (wth) platform to develop and evaluate a new remote monitoring enrollment model that is integrated with routine clinical care at penn family care (pfc), an academic family medicine practice in west philadelphia. among patients with poorly controlled htn the investigators will: 1. compare the effect of sending eligible patients a blood pressure cuff with the mailed invitation letter and opt-out framing versus the more conventional method of phone calls following mailed letters. 2. evaluate the feasibility and effectiveness of a remote monitoring program with individualized stepped escalation for hypertension management.

Eligibility criteria:
inclusion criteria: 1. between 18 and 75 years old with htn (icd-10 code i10) 2. has had at least one office visit at penn family care (pfc) within the past 12 months (at time of chart review), with the last visit having a bp reading exceeding htn guidelines (150/90 if \>60 or, 140/90 if ages 21-59 yrs or has ckd or diabetes). 3. must have a cellular phone with texting capabilities 4. must be prescribed at least one medication for hypertension exclusion criteria: 1. has metastatic (stage iv) cancer 2. has end stage renal disease 3. has congestive heart failure 4. has dementia 5. bmi \>= 50 6. is non-english speaking requiring a translator

Keywords: blood pressure remote monitoring
cyanobacteria allergy in lake kineret

Conditions: Nasal Stuffiness; Sneezing; Itching

Summary: people swimming or surfing in lake kineret , sometimes complain of nasal stuffiness , sneezing and itching .typically, it happens during or immediately after contact with the lake's water . the symptoms are compatible with immediate allergic reaction. previous reports suggested a connection between similar symptoms and contact with different cyanobacteria (living in fresh water lakes). in this study we intend to prove the mechanism of these reactions. to prove the exact allergen that causes allergic rhinitis allergists perform skin tests with different suspected allergens. likewise, we would like to perform skin tests to different proteins extracted from cyanobacteria collected in lake kineret.


Eligibility criteria:
inclusion criteria: * age above 18 * exposed to lake keneret water by swiming or sirfing exclusion criteria: * age under 18 * pregnancy

Keywords: allergy cyanobacteria sweet water swimming