Kornimate/medical-research-clean huggingface dataset:
use of pedometer following radical prostatectomy

Conditions: Prostate Cancer; Ambulation Difficulty

Summary: this is a study to evaluate whether use of a pedometer following radical prostatectomy decreases post-operative narcotic use and time to return of bowel function.

this is a randomized controlled prospective study looking at the effect of using a pedometer with graduated step-count goals following radical prostatectomy on return of bowel function and post-operative narcotic use. subjects will be randomized into a control group or study group. the control group will receive standard of care, with information provided regarding the importance of ambulation following surgery. the study group will receive a pedometer with graduated step-count goals from post-operative day 0 to post-operative day 14. both groups will be given a standardized post-operative narcotic regimen, and will be asked to record initial passage of flatus and first bowel movement. subjects will remain on the study until initial post-operative visit.

Eligibility criteria:
inclusion criteria: this study will include men 18-75 undergoing robot-assisted laparoscopic radical prostatectomy for prostate cancer at virginia mason medical center. exclusion criteria: * long-term opioid use, defined by cdc as use of opioids on most days for \>3 months * history of inflammatory bowel disease * prior abdominopelvic radiation * travel to europe during study period * concurrent surgery during radical prostatectomy * inability to ambulate * gastroparesis or other baseline bowel dysmotility issues * inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Keywords: radical prostatectomy pedometer return of bowel function post-operative narcotic use
canadian continuation of roll-over study in patients with endogenous cushing's syndrome

Conditions: Endogenous Cushing Syndrome

Summary: the purpose of this study is to continue the evaluation of long-term safety of osilodrostat in 7 canadian patients who have already received osilodrostat treatment in a previous global recordati-sponsored roll-over study and who, based on investigators' judgement, will continue benefiting with its administration.

there will be no screening period for this study. eligible subjects can start their treatment with osilodrostat as soon as they are enrolled in the study. the first study visit will be scheduled at the time of the last study visit for the parent study. subjects must return to the study center at least on a quarterly basis (every 12 weeks ± 2 weeks) for safety and clinical benefit assessments, and resupply of study medication. drug dispensing and administration information and adverse events will be collected. the subject may return to the clinic at any given time as per standard of care or treating physician recommendation; however, only the quarterly study visits will be recorded in the case report form (crf). study medication dispensed will be recorded in the crf dose administration page. all adverse events and serious adverse events, including pregnancy, will be collected throughout the study. subjects will continue to be treated in this roll-over study until they are no longer benefiting from their osilodrostat treatment as judged by the investigator or until osilodrostat is commercially available or until one of other discontinuation criteria is met.

Eligibility criteria:
inclusion criteria: 1. patient is currently participating in a global recordati-sponsored roll-over study receiving osilodrostat for any type of endogenous cs and has fulfilled all their requirements in the parent study. 2. the patient is currently benefiting from treatment with osilodrostat, as determined by the investigator. 3. patient has demonstrated compliance, as assessed by the investigator, with the parent roll-over study protocol requirements. 4. willingness and ability to comply with scheduled visits and treatment plans. 5. written informed consent obtained prior to enrolling into the study exclusion criteria: 1. patient has been permanently discontinued from osilodrostat study treatment in the parent roll-over recordati-sponsored study. 2. new patients not previously enrolled in parent roll-over recordatisponsored study. 3. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory evaluation.

Keywords: endogenous cushing syndrome cushing syndrome osilodrostat long term safety canada
effect of topical anesthesia on hemodynamics during the induction period in patients undergo cardiac surgery.

Conditions: Coronary Artery Disease; Valvular Heart Disease; Arrhythmia; Myocardial Disease

Summary: the aim of the induction is to decrease stress response of endotracheal intubation. it is also important to keep hemodynamics stable during and after the induction period. previous studies have shown that topical anesthesia can provide excellent superior supraglottic and subglottic local anesthetic effects and can significantly reduce the dosage of intravenous anesthetics. therefore, it is significant to explore whether the combination of topical anesthesia and intravenous anesthetics could decrease the stress response of endotracheal intubation and keep hemodynamics stable during and after the induction period.

the routine anesthesia induction strategy for cardiac surgery is to decrease stress response during endotracheal intubation by using large doses of opioids. however, high doses of opioids often leads to persistent and recurrent hypotension in patients from the anesthesia induction period to the beginning of the surgery. patients scheduled to accept cardiac surgery often have severe concomitant disease. hemodynamic fluctuation might lead to disastrous events. anesthesia induction for such patients should not only provide adequate depth of anesthesia to decrease the stress response of endotracheal intubation, but also make hemodynamics stable after tracheal intubation.

Eligibility criteria:
inclusion criteria: 1. patients scheduled to accept elective /major cardiac surgery; 2. patients older than 18 years and younger than 85 years; 3. patients of the american society of anesthesiologists ( asa )ⅱ - ⅳ level grade; 4. patients signed the informed consent form for the clinical study; exclusion criteria: 1. patients cannot cooperate to topical anesthesia; 2. patients with a left cardiac assist device prior to surgery; 3. patients with aortic dissection; 4. patients with intra aortic balloon pump (iabp) prior to surgery; 5. patients treated with extracorporeal membrane oxygenation (ecmo) prior to surgery; 6. patients with difficult airway; 7. patients with high sensitivity and hypersensitivity to lidocaine and tetracaine; 8. patients with atrioventricular block; 9. hemoglobin(hb)\<80g/l； 10. patients who have participated in other clinical studies during the last 3 months;

Keywords: topical anesthesia cardiac surgery hemodynamics induction period
study of dual-energy (de) contrast-enhanced (ce) digital mammography

Conditions: Breast Cancer

Summary: this is a feasibility study to evaluate dual-energy (de) contrast-enhanced (ce) digital mammography to detect breast cancer in patients with increased breast density (bi-rads category c or d). eligible patients will be invited to have full-field digital mammography and dual-energy (de) contrast-enhanced (ce) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer.

this is a feasibility study to evaluate dual-energy (de) contrast-enhanced (ce) digital mammography to detect breast cancer in patients with increased breast density (breast imaging-reporting and data system category c or d). eligible patients will be invited to have full-field digital mammography and dual-energy (de) contrast-enhanced (ce) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. at least 19 years old 3. glomerular filtration rate\> 60 4. heterogeneously or extremely dense breasts (bi-rads category c or d). exclusion criteria: 1. history of iodinated contrast allergy 2. pregnant or lactating as determined by routine standard practice 3. personal history of breast cancer 4. history of prior breast excisional biopsy (patients with a history of core needle biopsy will not be excluded) 5. history of prior breast reduction mammoplasty surgery 6. history of prior breast augmentation surgery 7. mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

Keywords: breast cancer screening dense breasts dual-energy contrast-enhanced digital mammography
influence of insertion torque and bone type on post-operative pain

Conditions: Postoperative Pain; Postsurgical Pain; Dental Implant Failed

Summary: the objectives of this clinical study were to assess the effect of different its and bone types on pop levels and survival rates and to investigate the effect of different patient- and site-related factors on pop levels and survival rates.

this prospective clinical study included 230 patients treated with a single tapered screw implant (bioinnovation dental®, brazil). the implants were placed using the appropriate burs with a final master drill of 3.5 or 4.5 mm in diameter by one senior oral surgeon. these implants were multi-threaded, and their surfaces were both sandblasted and acid etched. of the 230 participants, 172 received a single 5 x 10-mm implant, and 58 received a 4 x 10-mm implant. for the higher torque range (90 - 200 ncm), the maximum it was recorded with an electronic digital torque measuring device (tohnichi btge200cn-g, hitachi, japan), while a different gauge (tohnichi btg90cn-s, hitachi, japan) was used for the lower torque range (10 - 90 ncm). all implants were placed at the crestal level and closed with a cover screw, and the flap was then sutured with non-resorbable 4/0 nylon suture (resorba® germany). pain levels were recorded at day 1, 2 and 4 and at week 1, 2 and 3 after surgery using visual analog scale (vas) ranging from 0 "no pain" to 10 "worst pain ever. implants were classified into 4 groups based on the it value; low: 60 implants (10-29 ncm, mean=15 ncm); regular: 102 implants (30-50 ncm, mean=42 ncm); high: 47 implants (51-100 ncm, mean=75 ncm); and very high: 21 implants (101-200 ncm, mean=170 ncm). implant survival was assessed clinically and radiographically at 3, 6, 12, 24 and 36 months. the criteria for implant success according to buser et al, were no radiolucent zone around the implant, confirmed individual implant stability, and no suppuration, pain or ongoing pathologic processes. all implants that failed to fulfill these success criteria were regarded as failures. the effect of it, bone type, implant location, age, gender and smoking was measured with regression analysis. kaplan-meier survival analysis was performed to calculate the overall implant survival probabilities. the level of statistical significance was set at p\<0.05.

Eligibility criteria:
inclusion criteria: * partially edentulous patients who presented with one or more missing teeth in the maxillary or mandibular jaw * at least18 years old, adequate oral hygiene * absence of infection or periodontal problems adjacent to the implant site - sufficient bone thickness with a minimum 6-mm width and 12-mm length to accommodate implants of 4 or 5 mm in diameter and 10 mm in length. exclusion criteria: * uncontrolled diabetes * hypertension * pregnancy * bone diseases * use of bisphosphonates * heavy smoker (more than 20 cigarettes /day) * severe alcohol or drug use * patients with recent extraction of teeth and patients requiring bone and soft tissue augmentation procedures.
conscious sedation for cataract operations under topical anaesthesia

Conditions: Conscious Sedation

Summary: topical anaesthesia of the eye for ophthalmologic procedures avoids pain and discomfort of local anaesthetic injection in the peribulbar or retrobulbar block so that patient comfortability is achieved. sedation during topical anaesthesia of the eye is mostly required to achieve anxiolysis, amnesia and keeping the patient calm all through the procedure. in the present study, the investigators will investigate the effect of nalbuphine/dexmedetomidine versus nalbuphine/propofol on the sedation as a primary outcome, intra-operative, postoperative analgesia, vital signs, patient and surgeon satisfaction and side effects as secondary outcomes

in both groups, the patients will receive i.v. nalbuphine 50 μg/kg. patients in group d, will receive an i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h. patients in group p, will receive a bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion started at 0.025 mg/kg/min .if sedation score was \<3, rescue sedation with boluses of midazolam 0.01 mg/kg will be given. if the patient complained of pain (numerical verbal pain rating scale ≥3) during the surgery, i.v. fentanyl 50 μg will be given as an intra-operative rescue analgesic and the surgeon will be instructed to use additional topical local anaesthetic eye drops if appropriate. after the completion of surgery, all infusions will be stopped, and the patients will be shifted to the postanaesthetic care unit (pacu) to be monitored for 2 hours before discharge.

Eligibility criteria:
inclusion criteria: * both genders, * 20 and 65 years, * american society of anesthesiologists (asa) physical status i and ii, * scheduled for cataract extraction surgery under topical anaesthesia. exclusion criteria: * known allergy to local anaesthetics, * allergy to study drugs, * second or third-degree heart block, * alcohol or drug abuse * morbid obesity, pregnant and lactating females, * patients with severe cardiac, renal and hepatic disorders.
post-operative urinary retention (pour) following thoracic surgery

Conditions: Urinary Retention

Summary: inability to urinate a common complication that happens to many patients after a surgery, especially in men over 60 years of age who undergo surgery on their chest. urinary retention is uncomfortable, increases anxiety, increases hospital length of stay, and leads to more procedures such as putting in a bladder catheter (foley). this is uncomfortable, and can lead to bleeding, infection, damage to the urethra and/or bladder and bladder spasm. the goal of this study is to attempt to prevent inability to urinate by giving patients a medication called flomax (tamusolin) every day beginning a week before surgery. that medication relaxes the prostate. it's approved by the food and drug administration (fda) to improve urinary flow in those with enlarged prostates. it is also commonly used in patients with bladder problems due to inability to urinate who have required a foley.

post-operative urinary retention (pour) in older men who undergo a thoracic surgical procedure occurs in a significant proportion of patients (25% at hackensack university medical center in men \>60) and is a significant management problem. typically, this complication needs to be treated with placement of a bladder catheter (foley). in addition to the discomfort of placing a foley in an awake patient, these patients are at a significantly increased risk of a catheter associated urinary tract infection (cauti), potential genito-urinary injury during the placement, and bladder muscle damage due to distention. the goal of this study is to investigate whether the use of tamusolin could lower the high incidence of pour in older men undergoing a thoracic surgical procedure. the investigators hypothesize that pre-operative administration of tamusolin (flomax, 0.4mg/day x 1 week), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of pour after a thoracic surgical procedure.

Eligibility criteria:
inclusion criteria: males ≥50 years old planned surgical procedure of a minimally invasive thoracic surgical procedure (wedge resection, segmentectomy, lobectomy, pleural biopsy, or pleurodesis) surgery scheduled more than 3 days from the time of consent exclusion criteria: * using flomax already * allergy to flomax or sulfa drugs * current use of alpha blockers or alpha agonists * resting systolic blood pressure \<100 * orthostatic hypotension of \>20mm hg (millimeters of mercury) systolic and/or 10mm hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent * known diagnosis of congestive heart failure and valvular heart disease * history of prostate surgery (prostatectomy, trans-urethral resection)

Keywords: post operative urinary retention inability to urinate urinary retentions lung cancer vats robotic lung surgery lung resections
study of azasite versus vigamox concentrations in the conjunctiva and aqueous humor in subjects undergoing routine cataract surgery

Conditions: Bacterial Infections; Eye Infections; Cataract Extraction

Summary: the purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of azasite™ compared to vigamox® in subjects undergoing routine cataract surgery


Eligibility criteria:
inclusion criteria: * are scheduled to undergo routine cataract surgery by the investigator's preferred technique. * have normal appearing, freely mobile, conjunctiva in the inferior temporal portion cul-de-sac site of the operative eye. exclusion criteria: * have concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. * have a history of ocular pemphigoid. * have ever had penetrating ocular surface surgery. * have had intraocular surgery within the past 3 months. * have ever had prior surgery or full penetrating trauma to the conjunctiva at the proposed surgical site. * have a planned cataract surgery in the contraleteral eye within 2 weeks of the study related surgical procedure and sample collection. * have a combined procedure planned (trabeculectomy surgery planned in the same eye as cataract extraction surgery). * have at the proposed conjunctiva biopsy site, signs of conjunctival shortening of the fornix, scarring or adherence to the underlying episclera. * have according to the investigator's judgment, risk of intra- or post-operative complications related to their cataract surgery as a consequence of participation in the study. * have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in azasite. * have had a known hypersensitivity to vigamox or any fluoroquinolone antibiotics or to any of the ingredients in vigamox. * are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the ocular or systemic use of either azithromycin or moxifloxacin, when it is the same medication as the subject's assigned study drug. this relates as well, to the use of either of these medications as a pre-surgical prophylaxis. * are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the use of erythromycin ointment or ofloxacin. * have any ocular pathology with the exception of cataracts that in the judgment of the investigator could confound study assessments or limit compliance. * have a serious systemic disease or uncontrolled medical condition or psychiatric condition that in the judgement of the investigator could confound study assessments or limit compliance.
oral morphine versus ibuprofen

Conditions: Upper Extremity Fractures; Analgesia Post Fracture

Summary: children 5-17 years of age who have sustained a non-operative distal forearm (radius and/or ulna) or clavicular fracture will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for the first 24 hours following discharge from the emergency department. pain will be assessed using the self-report faces pain scale revised (fps-r). we hypothesize that oral morphine will result in greater pain relief than ibuprofen.


Eligibility criteria:
exclusion criteria: * patients with known hypersensitivity to either ibuprofen or morphine * chronic users of nsaids or opioids * fractures requiring operative management * associated injuries requiring analgesia * poor english fluency * pregnancy inclusion criteria: * all patients aged 5 to 17 years with a non-operative forearm or distal radius fracture

Keywords: fracture pediatric oral morphine ibuprofen
trial of enhanced pre-consent discussion

Conditions: Pediatric Crohn's Disease

Summary: nested within the combine pragmatic clinical trial, the investigators will conduct a cluster randomized controlled trial to determine whether, in parents (of children with crohn's disease) or patients \> 18 years old being approached for trial participation, a pre-consent discussion enhanced with decision aids is more effective than the standard pre-consent discussion in transferring knowledge to parents/patients related to trial participation.


Eligibility criteria:
inclusion criteria: * parent of a child who is eligible for the combine trial (clinicaltrials.gov identifier: nct02772965) * patient who is eligible for the combine trial (clinicaltrials.gov identifier: nct02772965) exclusion criteria: * non-english speaking
a study of bms-986012 in combination with carboplatin, etoposide, and nivolumab as first-line therapy in extensive-stage small cell lung cancer

Conditions: Extensive-stage Small Cell Lung Cancer

Summary: the purpose of this study is to demonstrate that treatment with bms-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (es-sclc).


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented extensive-stage small cell lung cancer (es-sclc) and extensive-stage disease (american joint committee on cancer, 8th edition, stage iv \[t any, n any, m1a, m1b, or m1c\], or t3-4 due to multiple lung nodules that are too extensive or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan) * participants taking part in the separate pet tracer sub-study must provide a fresh tumor biopsy from any disease site (primary or metastatic) * archived tumor specimens, in the form of blocks or sectioned slides, are mandatory for all participants except those participating in the separate pet tracer sub-study for whom the archived tumor specimen is optional * eastern cooperative oncology group performance status (ecog ps) 0 or 1 * at least 1 measurable lesion by computed tomography (ct) or magnetic resonance imaging (mri) per response evaluation criteria in solid tumors version 1.1 (recist v1.1) criteria * adequate hematologic and end organ function * must agree to follow specific methods of contraception, if applicable exclusion criteria: * women who are pregnant or breastfeeding. japan only: participation in the study is not allowed even if breastfeeding is suspended * prior chemotherapy, radiation therapy, or biologic therapy for sclc. previously treated limited stage sclc (ls-sclc) participants are also excluded * symptomatic brain or other central nervous system (cns) metastases * paraneoplastic autoimmune syndrome requiring systemic treatment * history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest ct scan * grade ≥ 2 peripheral sensory neuropathy at study entry * significant uncontrolled cardiovascular disease * active, known or suspected autoimmune disease or inflammatory disorder other protocol-defined inclusion/exclusion criteria apply

Keywords: bms-986012 carboplatin etoposide extensive-stage small cell lung cancer fucosyl nivolumab targeted sclc therapy