Kornimate/medical-research-clean huggingface dataset:
neobladder posterior wall suspended with round ligament of uterus

Conditions: Female; Bladder Cancer; Radical Cystectomy; Neobladder; Posterior Wall Suspended With Round Ligament of Uterus

Summary: objective: to evaluate if the neobladder posterior wall suspended with round ligament of uterus could improve neobladder empty after radical cystectomy in female patients with bladder cancer compared to present standard neobladder

the investigators developed a technical modification which to aim to provide an posterior support to the ideal neobladder and obtain the anatomy recovered neobladder by posterior wall of neobladder suspended with round ligament. in this study the investigators designed the prospective random trial to evaluate whether this technique improves the neobladder empty compared to a current standard neobladder reconstruction.

Eligibility criteria:
inclusion criteria: * the inclusion criteria for the study were bladder cancer (stage t1g3, t2-3n0-nxm0), female (age between 40 and 70 years old), no history of urethral trauma or urethral stricture; and a desire to obtain an orthotopic neobladder exclusion criteria: * the exclusion criteria were male sex, posterior urethral margin confirmed as cancer invasive by pathology; and enteritis. the indications and contraindications for orthotopic reconstruction in this study conformed to the criteria set by the guidelines of the european association of urology on bladder cancer
ecap-controlled, closed-loop stimulation to treat chronic trunk and/or limb pain (ecap)

Conditions: Chronic Pain; Back Pain; Pain

Summary: the purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the evoke system to treat trunk and/or limb pain in a real-world population.


Eligibility criteria:
inclusion criteria: * subject has chronic intractable pain of the trunk and/or limbs. * subject is willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits. exclusion criteria: * subject is unable to operate the system. * subject is an unsuitable surgical candidate. * subject has a condition currently requiring or likely to require the use of diathermy. * subject has another implantable stimulator such as demand type pacemakers or cardioverter defibrillator. * subject is \<18 years old. * subject is pregnant or nursing. * subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body. * subject is being treated with electroconvulsive therapy (ect) or transcranial magnetic stimulation (rtms).

Keywords: chronic pain back pain leg pain pain neurologic manifestations nervous system diseases signs and symptoms scs closed loop
duvelisib in hepatically impaired subjects compared to healthy subjects

Conditions: Hepatic Impairment

Summary: to evaluate the pharmacokinetics, safety, and tolerability of ipi-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.

this is a nonrandomized, open-label, parallel-group, single oral dose study in subjects with chronic hepatic impairment and matched (age, sex, weight, bmi) healthy subjects. subjects will be enrolled into 1 of 3 groups based on hepatic impairment grade: mild, moderate and normal hepatic function. an optional severe hepatic impairment group will enroll based on data from the mild and moderate hepatic impairment groups in comparison to matched healthy group. all subjects will receive a single oral dose of ipi-145 25 mg.

Eligibility criteria:
inclusion criteria: * men or women of nonchildbearing potential between 18-70 years of age * body mass index (bmi): 18.0 - 38.0 kg/m2. * healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations * hepatic impairment subjects: confirmed hepatic impairment \>1 year with etiology of chronic alcoholism, chronic viral hepatitis (b or c), nonalcoholic steatohepatitis, autoimmune hepatitis, wilson disease, alpha-1 antitrypsin deficiency, glycogen storage diseases, or galactosemia * provided written informed consent prior to any study specific procedures exclusion criteria: * women of childbearing potential * hepatic impairment subjects: fluctuating or rapidly deteriorating hepatic function, acute hepatitis, variceal bleeding within 8 weeks of screening, a history of pancreatitis within 8 weeks of screening, evidence of hepatic encephalopathy \> grade 1, current unstable hematologic condition, and/or creatinine clearance \< 60 ml/min * healthy subjects: positive screening test for hepatitis b surface antigen, or hepatitis c antibody * ecg at screening or day -1 showing qtcf ≥ 450 msec for healthy subjects or \> 500 msec for hepatically impaired subjects * evidence of clinically significant medical conditions * history of gastrointestinal disease or surgery that may affect drug absorption * positive or indeterminate quantiferon-tb gold test at screening * any active infection at the time of screening or admission

Keywords: phase 1 hepatic impairment
the relationship between the residual renal function and osteoporosis treatment

Conditions: Osteoporosis

Summary: the relationship between osteoporosis drugs and kidney damage is unclear. in this study, we plan to reveal relationship between osteoporosis drugs and kidney damage.

chronic kidney disease (ckd)- mineral and bone disorder (ckd-mbd) is one of the topic in osteoporosis treatment. as many osteoporotic patients are older, many patients are under the deterioration of the renal function. in addition, several drugs might have the potential for kidney damage. but the relationship between osteoporosis drugs and kidney damage is unclear. the main objective of this study is to reveal relationship between osteoporosis drugs and kidney damage.

Eligibility criteria:
inclusion criteria: * osteoporosis patients exclusion criteria: * egfr \< 15

Keywords: osteoporosis bone mineral densisty renal function ckd-mbd
characterization of influenza-like illness in mexico

Conditions: Influenza-like Illness

Summary: a study to characterize children and adults with influenza like symptoms and to determine risk factors for severe disease and death among those with h1n1.

in march 2009, a new influenza a virus, novel h1n1 (commonly referred to as "swine flu"), began causing an increase in reports of influenza-like illness in north america. although the virus subsequently spread rapidly around the world, the earliest reported outbreak of cases occurred in mexico city, which is seen as the epicenter of the influenza pandemic, the world's first in 40 years. many questions remain about this emerging pandemic and the virus causing it, the answers to which could better inform patient management and policy decisions both in mexico and internationally. sparse reliable clinical research data have been collected on the natural history of the disease, on the risk factors associated with severe disease, or on the severity of this pandemic influenza as compared to seasonal influenzas. this study is an initial step to better characterize individuals in mexico who develop influenza-like illness (including illness caused by novel h1n1), to describe the clinical management of those individuals, and to assess their short-term outcome. the planned data collection will provide timely information to inform policy and guidelines for the local populations and governments involved and may also be used to design future ancillary studies of this influenza virus and/or studies of other emerging infectious diseases. the purpose of this observational study is to characterize individuals in mexico who seek medical care for influenza-like illness (ili) and to describe clinical course over a period of at least 28 days after enrollment.

Eligibility criteria:
inclusion criteria: * signed informed consent by participant, or for pediatric participants, signed informed consent by parent/legal guardian and, where appropriate, signed assent by participant * at least one respiratory symptom (e.g., shortness of breath, postnasal drip, cough) and * one of the following criteria: * fever (≥ 38 °c by any method: oral, axillary, etc.) on examination or participant-reported fever (≥ 38° c) or feverishness in the past 24 hours * one or more non-respiratory symptoms (e.g., malaise, headache, myalgia,chest pain) * consenting to provide aspirate or naso-pharyngeal swab exclusion criteria * the onset of illness is more than 48 hours after hospitalization. * participants previously included in this study within the last 30 days.
geriatric health exam osteoporosis screening

Conditions: Osteoporosis; Accidental Falls; Fracture

Summary: background: the world health organization fracture risk assessment tool (who frax®) taiwanese calculator is freely available on line to help osteoporosis management. however, its clinical utility for improving osteoporosis awareness and patient acceptance has not been validated in taiwanese population. objectives: this 11-month frax® based screening and referral program enrolling older adults participating in the geriatric health examinations (ghes) at the national taiwan university hospital (ntuh) aiming at determine the patient acceptance of the tool and the program and to improve patient awareness in osteoporosis. the second aim is to look for the recommendations from the participating physicians to improve the frax® -based osteoporosis management model. methods: the ntuh ghe program is a two stage process to serve 3,000 older adults collecting annually from mar. to dec. subjects will be enrolled to the current study at the stage 1 ghe visits after informed consent. baseline questionnaires including the frax® tools will be distributed and expected to be returned at the stage 2 visits. research assistants will calculate the 10-year predicted fracture risks for the participants during the waiting periods and present the numbers to the ghe physicians. high risks individuals will be referred to general geriatric clinic for further managements. all participants will be provided with osteoporosis and fracture educational material. patient acceptance and awareness will be assessed. the study is to be started from feb., to oct., 2013 to enroll roughly 1,800 older adults assuming refusal rate about 40%. qualitative interviews will be used to obtain recommendations from study geriatricians in jul., 2013 to optimize the frax® based screening and management model.

anticipated results: to estimate the 10 year fracture risks for ghe participants. to understand the acceptance of this frax® based model from ghe participants and the impacts on patient osteoporosis awareness. to calculate the economic benefits of this model on geriatric outpatient service. to obtain recommendations from study geriatricians to optimize the frax® based model for further disseminations.

Eligibility criteria:
inclusion criteria: * participation in the ntuh ghe program * can complete the study questionnaire * willingness to join in the researchers exclusion criteria: * na

Keywords: world health organization fracture risk assessment tool osteoporosis aged prevention fracture frax
effectiveness and cost-effectiveness of the energetic program

Conditions: Neuromuscular Diseases

Summary: fatigue is present in at least 60% of the patients with a muscle disease and can be the most disabling symptom. in combination with other impairments, this often results in low levels of physical activity and decreased social participation, leading to large societal costs. energetic is a self-management group program aimed at improving participation and physical endurance in these patients. our hypothesis is that energetic results in improved participation and improved physical endurance, less experienced fatigue and better quality of life compared to usual care, without increasing health care costs.


Eligibility criteria:
inclusion criteria: * formal diagnosis of muscular disease, either fascioscapulohumeral dystrophy (fshd), inclusion body myositis (ibm), mitochondrial myopathy (mm) or any other; * being severely fatigued * being cardiopulmonary stable and capable of aerobic training (as determined using a submaximal cycling exercise test with ecg (electrocardiography) and advice from a consultant cardiologist and pulmonologist); * being motivated, committed to the program, and 'ready to change' which is discussed with the patient during the screening by a rehabilitation physician and an occupational therapist; to this end, motivational interviewing will be used (including a advantages/disadvantages matrix; a visual analogue scale (vas) to rate the importance of participation in de program; and a vas to rate the confidence a patient has that participation in the program is feasible) * being able to formulate at least 3 individual participation goals during the interview with the occupational therapist. exclusion criteria: * active depression or other psychiatric disorder as indicated by a consultant psychologist or by the medical history, * pregnancy, * severe co-morbid condition, * having participated in the energetic program before * a travel distance perceived as too burdensome

Keywords: social participation fatigue self-management rehabilitation physical therapy occupational therapy group intervention exercise
muscle, essential amino acids, and exercise in heart failure

Conditions: Heart Failure, Diastolic

Summary: half of heart failure patients have preserved ejection fraction (hfpef). like patients with reduced ejection fraction (hfref), hfpef patients suffer from exercise intolerance (low vo2max), which reduces physical function, quality of life, and survival. strikingly, there is no medication proven to increase survival for hfpef patients. whereas exercise intolerance in hfref patients is the result of cardiovascular limitations, physical dysfunction in hfpef patients is largely the result of peripheral abnormalities in skeletal muscle. indeed, research in hfpef patients identified that physical function and vo2peak are directly related to leg lean mass, and drugs focused on improving cardiovascular function have failed to improve vo2peak. unfortunately, no therapy has been identified for this population that can concurrently improve cardiovascular and muscle health. the need for improved muscle therapies is reinforced by the fact that hfpef patients are commonly older adults who are predisposed to muscle wasting. strategic essential amino acid (eaa) ingestion has been shown to improve the adaptive response of muscle to exercise. therefore, the investigators will determine, in hfpef patients, the extent to which ingesting a strategic mixture of eaas during an acute aerobic exercise training program enhances the response to this exercise strategy.


Eligibility criteria:
inclusion criteria: * age 60+ years of age * able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent. * diagnosed with hfpef as per established echocardiographic criteria (new york heart association class ii-iii). exclusion criteria: * unstable angina, myocardial infarction in the past 4 weeks * uncompensated heart failure * new york heart association class iv symptoms, complex ventricular arrhythmias, symptomatic severe aortic stenosis, acute pulmonary embolus, acute myocarditis, untreated high-risk proliferative retinopathy, recent retinal hemorrhage, uncontrolled hypertension, baseline blood screening abnormalities * medication non-compliance * medical / orthopedic conditions precluding exercise * exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise) * subjects on anti-coagulation medication will not be eligible for the muscle biopsy procedure, but are deemed eligible for study participation if inr \< 3.
opioid-free pain control regiment following robotic radical prostatectomy

Conditions: Radical Prostatectomies

Summary: this study will address the gaps in research of non-opioid postoperative pain management for prostatectomies.

this study will conduct a randomized control double-blind clinical trial to evaluate an opioid versus a non-opioid pathway of gabapentin, ketorolac, and acetaminophen in treating postoperative pain following robot-assisted radical prostatectomy (rarp).

Eligibility criteria:
inclusion criteria: * all men ages 40-75 undergoing bilateral robot assisted radical prostatectomy (rarp) with bilateral lymph node dissection with low-intermediate to high-risk localized prostate cancer exclusion criteria: * allergies to any medication involved in the study * t4 prostate cancer * incarcerated persons * chronic narcotic dependence * any current prescription for narcotics * any surgery in the past 6 months

Keywords: opioids postoperative pain
clinical trial in antiaggregated patients with proximal femur fracture evaluating a strategy to shorten time until surgery

Conditions: Femur Fracture

Summary: national, randomized, open, parallel, multicenter clinical trial of two comparison groups that will evaluate the feasibility of a strategy based on a diagnostic test to shorten the surgery time in antiaggregated patients with proximal femur fracture. the experimental group will undergo surgery as soon as platelet aggregability, according to the plateletworks® method is correct within 24-48 hours. the control group will undergo surgery according to the usual practice of the center taking into account the safety time of the antiplatelet agent.


Eligibility criteria:
inclusion criteria: * patients older than 18 years * patients of both sexes * patients with a proximal femoral fracture requiring surgery * patients receiving antiplatelet agents at the time of admission to the emergency room: aas\> 100 mg / d (aspirin®), trifusal\> 300 mg / d (digren®; edigen®), clopidogrel (plavix®), prasugrel ®), ticagrelor (brilique ®) and ticlopidine (tiklid ®). * patients who give their signed consent exclusion criteria: * multiple fractures * pathological fractures * patients receiving vitamin k antagonist oral anticoagulants (warfarin and acenocoumarol) or new oral anticoagulants (apixaban, rivaroxaban and dabigatran) or who have acquired congenital or acquired coagulopathy * patients with aas ≤100mg, trifusal ≤300mg * patients who do not give their informed consent or their legal guardian
feast perinatal support program intervention

Conditions: Diet, Healthy; Obesity; Cardiometabolic Syndrome

Summary: latino individuals face an elevated risk of adverse health outcomes during pregnancy, impacting both the birthing parent and the baby with potential long-term chronic health conditions. while promoting a healthy diet during pregnancy is a promising strategy, interventions targeting dietary behaviors have yielded mixed results and lack widespread dissemination in communities in need. collaborating with community-based organizations could enhance cultural relevance, build trust with latino families, and improve program reach and effectiveness. food education access support together (feast) is a community-based program that promotes healthy eating, well-being, and health equity for diverse, under-resourced urban populations in los angeles. the newly developed feast perinatal support program (psp) aims to support individuals through pregnancy and postpartum by providing dietary psychoeducation, skill-building, and social support, with an additional component of grocery gift cards to address food access barriers. this study proposes a randomized controlled pilot trial to assess the feasibility and preliminary efficacy of the feast psp in enhancing dietary outcomes, overall health, and socio-cognitive precursors, in pregnant individuals. the study will enroll 40 pregnant adults (\>70% latino) randomly assigned to one of two different groups: core psp with a $15 gift card for healthful fresh food (psp+giftcard) and a waitlist control group. pre- and post-intervention assessments will include questionnaires, dietary recalls, physical measurements, and interviews to evaluate program perceptions. specific aims include evaluating program feasibility and acceptability (i.e., reach, retention, and participant perceptions) and determining preliminary efficacy on changing socio-cognitive and behavioral aspects of diet, self-reported health, and cardiometabolic risk factors. the project aligns with goals of improving health outcomes in latino families in southern california and supports feast's strategic objectives for improving health and wellness of individuals during pregnancy and throughout the lifespan. the findings will inform program refinement and future nih grants for rigorous evaluation of the feast psp.


Eligibility criteria:
inclusion criteria: * currently pregnant * speak and read english * first pregnancy * eligible for electronics benefit transfer (ebt) and/or women, infants, and children (wic) benefits exclusion criteria: * inability to attend in-person sessions
lumbar steroid use in patients undergoing posterior lumbar decompression

Conditions: Opioid Use; Lumbar Spinal Stenosis; Pain, Postoperative; Pain, Back

Summary: this study seeks to evaluate the impact of intra-operative topical epidural steroid usage in patients undergoing 1-2 level lumbar laminectomy. the study will examine post-operative opioid usage, length of stay, return to work, and patient reported outcomes following these procedures.

this is a randomized controlled trial seeking to evaluate the impact of intra-operative topical epidural steroid usage in patients undergoing 1- to 2- level lumbar laminectomies. subjects enrolled in this study will be randomized to one of two treatments: either 40 mg depo-medrol or 1 ml of sterile normal saline will be applied to the surgical wound prior to closure. the study will examine post-operative opioid usage, length of stay, return to work, and patient reported outcomes following these procedures. subjects will be assessed pre-operatively, while admitted for surgery, and postoperatively daily for two weeks, then again at 1- and 3- months.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo 1 to 2 level laminectomy * between the ages of 18-85 exclusion criteria: * minimally invasive surgery * prior daily opioid usage within 6 months. * use of concomitant procedures such as spinal fusion, revision procedure at the same level. * history of a chronic pain syndrome, uncontrolled diabetes defined as a1c \> 6.5, immunocompromised condition such as active cancer treatment, history of transplant, benign prostatic hyperplasia or history of urinary retention, and other conditions which require chronic steroid therapy or immunosuppressants. * non-english speakers * patients allergic to depo-medrol and/or glucocorticoids, or other steroids
assessment of fluoroscopy times with surgeon versus technologist control

Conditions: Urolithiasis; Kidney Stones

Summary: this is a prospective randomized trial to study the effect of assigning the control of the fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist. radiation exposure will be assessed from the collected data, fluoroscopy time, and dose parameters (cumulative absorbed dose and dose area product). from exposure data, entrance skin dose (esd) and midline absorbed dose (mld) will be calculated. the primary outcome in this study will be total fluoroscopy time for the procedure. a secondary outcome will be the esd. the investigators will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and esd. it is hypothesized that a 30% reduction in fluoroscopy time will occur when the operating surgeon is controlling the activation of the x-ray beam.


Eligibility criteria:
inclusion criteria: * patients undergoing ureteroscopy for urolithiasis * 5 years to 25 years old exclusion criteria: * pregnant * less than 5 years old or older than 25 years old

Keywords: urolithiasis kidney stones ureteroscopy fluoroscopy