Kornimate/medical-research-clean huggingface dataset:
the iseo biofeedback tool during the rehabilitation of patients treated for rotator cuff tear

Conditions: Rotator Cuff Tears

Summary: the present study addresses the issue about post-surgical recovery process, for patients arthroscopically treated for rotator-cuff tear. the aim of the research is to test the effectiveness of a new rehabilitation protocol that includes kinematic biofeedback with the motion analysis system iseo.

the research includes at least 62 patients arthroscopically treated for the rotator cuff tear. for this purpose, two groups of patients of equal size are identified. the attribution of each patient to one of the two groups is random. the standard rehabilitation protocol is applied to the control group (group a), whereas the standard rehabilitation protocol integrated by proprioception exercises (physical therapist assisted) performed with iseo is applied to the experimental group (group b). the primary objective is to verify if the iseo system, used as a biofeedback tool, improves shoulder functionality and activity of patients arthroscopically treated for rotator cuff tear, both in the short (90 days from surgery) and in the medium term (6-12 months from surgery). all patients are longitudinally evaluated from the pre-surgery to a 6/12 months follow-up. each evaluation includes both a clinical and an instrumented assessment of shoulder kinematics. the primary outcome tested is the scapula-weighted constant-murley score, which represents a reformulation of the constant-murley score, which is modified based on the quality of the scapular movement measured with iseo.

Eligibility criteria:
inclusion criteria: * patients with rotator cuff injuries; * asymptomatic contralateral shoulder, that can be considered as a reference for the differential evaluation; * indication for arthroscopy; * employees; * rehabilitation executed at ausl-romagna. exclusion criteria: * irreparable injuries of the rotator cuff; * contralateral painful shoulder; * patients being treated for cancer in the last 6 months; * patients with concomitant neurological pathologies; * patients with spinal cord injuries; * patients with cuff lesions with infectious processes; * patients with severe scoliosis; * patients with recurrent lesions of the cuff; * patients with occupational diseases or work-related accidents; * patients for whom the return to work cannot be reliably established.

Keywords: shoulder biofeedback kinematics
evaluation of inhaled treatment in sinusitis

Conditions: Sinusitis

Summary: the purpose of this study is to determine whether inhaled corticosteroid (specially nebulized) could be a good alternative to oral corticosteroid and whether they are effective in the treatment of sinusitis


Eligibility criteria:
inclusion criteria: * nasal/sinus polyps exclusion criteria: * previous sinus surgery * age under 18y * use of antibiotics
non-invasive blood pressure and cardiac output measurement by using applanation tonometry

Conditions: Atrial Fibrillation; Left Ventricular Failure; Left Ventricular Impaired Function; Aortic Valve Stenosis

Summary: to evaluate and to validate accuracy, precision and trending ability of blood pressure and cardiac output measurement by applanation tonometry in cardiological patients having: * atrial fibrillation * severe impaired leftventricular function * severe aortic valve stenosis * patients having left ventricular assist device experimental measurement: continuous blood pressure measurement and cardiac output measurement is performed by the t-line 200 pro device (tensys medical inc., san diego, usa) control measurement: gold-standard continuous blood pressure measurement is performed by invasive blood pressure measurement by arterial cannulation and cardiac output reference is assessed by transcardiopulmonary thermodilution

increasing complexity of medical interventions and critical care treatment in an elderly getting population requires precise and accurate hemodynamic monitoring.(1) however, advanced invasive hemodynamic monitoring is often combined with complications by arterial or central venous catheterization. complications such as vessel harming, infection, cardiac arrhythmias and nervous lesions are likely to occur.(2-4) therefore, in the past various techniques of minimal- or non-invasive hemodynamic monitoring devices have been evaluated.(5, 6) one of the very promising technique is continuous non-invasive blood pressure monitoring by applanation tonometry. published data revealed efficacy of this technique. (7) however, ability of this technique remains unclear in patients suffering from cardiological pathologies leading to changing stroke volumes as in arterial fibrillation, to highly reduces stroke volume as in severe impaired left-ventricular function or in severe aortic valve stenosis. further, ability of applanation tonometry in patients without having pulsatile blood flow such as in patients with left-ventricular assist device remains unclear. therefore, validation of this technique should be performed in the presented study. further development of applanation tonometry including pulse contour analysis now enables assessment of cardiac output. however, till now there is limited data assessing validation cardiac output measurement by this method. cardiac output validation should also be performed in the planed clinical study.

Eligibility criteria:
inclusion criteria: * atrial fibrillation * severe impaired leftventricular function * severe aortic stenosis * lvad patients exclusion criteria: * age \<18 years * pregnancy * patients having blood pressure difference of more than 10 mmhg on both arms (measurement by "riva-rocci" before study enrolment) * pre-existing on arterial vessels of the arms * patients who are not able to give informed consent

Keywords: left ventricular assist device
continuous theta burst stimulation (ctbs) and postoperative delirium

Conditions: Postoperative Delirium; Transcranial Magnetic Stimulation, Repetitive

Summary: to investigate the impact of ctbs on the incidence of postoperative delirium and changes of cognitive function in elderly patients after surgery. to explore whether short-term ctbs can reduce the risk of postoperative delirium as a preventive strategy.

postoperative delirium is the most common postoperative complications among elderly. nevertheless, there remains no effective medication or intervention been approved in postoperative delirium. recent research suggests that continuous theta burst stimulation (ctbs) has shown positive effect on improving global cognitive function in multiple mental disorders. however, the effects on cognitive function in postoperative delirium remain uninvestigated.

Eligibility criteria:
participants were included if they: 1. were 65 years old or older; 2. had orthopedic surgery under general anesthesia; 3. had normal cognitive function at enrolment \[for illiterate, mini-mental state examination (mmse) ≥ 17; for individuals with 1-6 years of education, mmse ≥ 20; for individuals with 7 or more years of education, mmse ≥ 24\]; 4. were able to complete cognitive assessments and the confusion assessment method (cam); 5. chinese mandarin as their native language; 6. were willing to participate and being competent to provide informed consent. patients were excluded if they: 1. had delirium assessed by cam before surgery; 2. had neurological diseases (e.g., stroke, parkinson's disease, etc.) according to international statistical classification of diseases and related health problems 11th revision (icd-11); 3. had mental disorders (e.g., major depressive disorder, dementia, etc.) according to diagnostic and statistical manual of mental disorders (fifth edition) (dsm-5); 4. had contraindications of ctbs (e.g., head trauma, history of epilepsy or metal implants in the head); 5. participating in other clinical studies at the time of screening; 6. having postoperative complications such as pulmonary infection, pulmonary embolism and stroke.

Keywords: postoperative delirium continuous theta burst stimulation
a comparison of epicept™ np-1 topical cream vs. oral gabapentin in postherpetic neuralgia (phn)

Conditions: Post Herpetic Neuralgia; PHN; Neuropathy; Nerve Pain

Summary: the purpose of this study is to compare epicept™ np-1 topical cream (2% ketamine / 4% amitriptyline) vs. oral gabapentin in the treatment of postherpetic neuralgia (phn)

this is a phase ii, multicenter, double-blind, randomized, placebo-controlled, parallel group study of np-1 and oral gabapentin in approximately 500 patients with phn. adult patients with pain resulting from phn and meeting all other eligibility requirements will be screened for 7 days to determine their average daily pain intensity. qualifying patients will be randomized on a 2:2:1 basis to np-1, oral gabapentin, or placebo. the treatment period will be 4-weeks.

Eligibility criteria:
inclusion criteria: * adult patients with pain for ≥ 3 months following onset of a herpes zoster rash exclusion criteria: * clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments.

Keywords: post herpetic neuralgia phn neuropathy nerve pain topical
study in genotype 2 or 3 patients with chronic hepatitis virus infection

Conditions: Hepatitis C Virus

Summary: to identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.


Eligibility criteria:
key inclusion criteria: * participants chronically infected with hepatitis c virus (hcv) genotype 2 or 3 * no previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin * body mass index (bmi) of 18 to 35 kg/m\^2, inclusive. bmi=weight (kg)/height (m)\^2 * males and females, 18 - 70 years of age key exclusion criteria: * liver transplant recipients * documented or suspected hepatocellular carcinoma * evidence of decompensated cirrhosis * history of chronic hepatitis b virus (hbv). patients with resolved hbv infection may participate * current or known history of cancer * any gastrointestinal disease or surgical procedure that may impact the absorption of study drug * inability to tolerate oral medication * poor venous access * severe psychiatric disease * history of chronic pulmonary disease * history of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant cardiac disease * history of or current electrocardiogram findings indicative of cardiovascular instability * preexisting ophthalmologic disorders considered clinically significant on eye * history of uncontrolled diabetes mellitus * any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise specified. * positive hepatitis b virus surface antigen, hiv-1 or hiv-2 ab * prior exposure to any hcv direct antiviral agent (eg, hcv protease, polymerase, previous nonstructural protein 5a inhibitors) * exposure to any investigational drug or placebo
preclinical cardiomyopathy and autonomic function in type 1 diabetes

Conditions: Diabetes Mellitus, Type 1; Diabetic Cardiomyopathies; Autonomic Neuropathy, Diabetic

Summary: type 1 diabetes mellitus is a chronic autoimmune disease, associated with an increased risk of cardiovascular diseases. the development of cardiomyopathy in type 1 diabetes, independent of hypertension and coronary heart disease, is still controversial. a possible mechanism for diabetic cardiomyopathy is autonomic dysfunction. this study aims to evaluate cardiac function and structure, and to relate them with autonomic dysfunction in type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus exclusion criteria: * hypertension * coronary artery disease * heart valve disease * ventricular dysfunction * radiotherapy or chemotherapy * alcoholism * limited acoustic window
effect of preoperative iron isomaltoside 1000 administration on hemoglobin concentration in patients undergoing transcatheter aortic valve implantation

Conditions: Aortic Stenosis (Treated With TAVI)

Summary: transcatheter aortic valve implantation (tavi) is a standard procedure for severe aortic stenosis patients with moderate or higher risk of surgery. several studies have reported the adverse effects of blood disorders, such as anemia and iron deficiency, on the prognosis of patients undergoing tavi, and many other studies have been conducted to find ways to prevent them. iron isomaltoside, the latest intravenous iron supplement, can effectively replenish iron store with a single high-dose injection. research has shown that a preoperative single high-dose iron isomaltoside (1000mg) safely increased hemoglobin levels after surgery in patients undergoing cardiac surgery. however, there have been no studies on the effect of ultra-short-term use of intravenous iron supplements prior to tavi procedure. therefore, we investigate the effect of a single high-dose of iron isomaltoside (20mg/kg, maximum dose: 1g) on the hemoglobin concentration after the tavi.


Eligibility criteria:
inclusion criteria: * patients older than 60 years and undergoing transcatheter aortic valve implantation (tavi) exclusion criteria: * emergency operation * cardiogenic shock or ventricular-assist device (eg. ecmo, iabp) * infectious condition * active bleeding * hypokalemia * severe chronic kidney disease (gfr(ckd-epi) \<30ml/min/1.73m2) or dialysis * patients taking erythropoietin * aplastic anemia, hemolytic anemia * hemochromatosis, hemosiderosis * uncompensated liver cirrhosis, acute hepatitis, alcoholism * peptic / duodenal ulcer, crohn's disease, ulcerative colitis * allergy to iron supplements or vitamin b12 * symptomatic asthma, eczema * immunologic disease (e.g. rheumatoid arthritis, systemic lupus erythematosus) * malignancy * patients being treated in the intensive care unit due to heart failure or other major complications * patients who participated in other clinical studies that could affect prognosis * patients who cannot understand the informed consent (eg. foreigner)
effects of environmental factors on opiate drug choice in opioid dependent individuals.

Conditions: Heroin Dependence; Opioid-Related Disorders

Summary: the purpose is to study how certain factors, including money, the amount of drug available and the amount of work effort, affect opiate drug choice.

a drug dependent person chooses to take drug more often (and suffer its long-term bad consequences) than choosing to engage in healthy activities (which have better long-term consequences). the present research will be conducted in a controlled laboratory setting with heroin abusers who are not seeking treatment to understand what factors guide their choices. this research focuses on environmental (i.e. non-medication) factors that affect choosing a drug versus money. findings from this research are likely to be important in developing a theoretical and practical basis for behavioral interventions as part of drug abuse treatment. hyd is a drug that is currently used as a cough suppressant and to relieve pain. participants in this observational study will take part in multiple trials in which they have the opportunity to choose hyd or money. on the first two experimental days, prior to choice sessions, participants will receive a sample of the drug doses that can be chosen. during test sessions, participants will have 12 opportunities to choose either drug or money. participants will use a computer to earn choices. respiration rate, oxygen saturation, heart rate, and blood pressure will be monitored throughout choice trials. self-report questionnaires will be completed at different times during the study. participants will be maintained on buprenorphine throughout the study, with a minimum 2-week lead before the experiment, and a fixed 3-week detoxification after study completion.

Eligibility criteria:
inclusion criteria: * opioid dependent, as determined by structured clinical interview for dsm-iv (scid) and addiction severity index (asi) * positive urine test for opiates * willing to use an adequate form of contraception for the duration of the study. * reads and writes english exclusion criteria: * psychiatric illness, as determined by the dsm-iv criteria * history of or current neurological disease, including structural abnormalities, seizures, infection, peripheral neuropathy, and head traumas * history of cardiovascular disease, myocardial infarction, chest pain, or edema * systolic blood pressure greater than 160mm hg or less than 95 mm hg: pr diastolic blood pressure greater than 95 mm hg. * pulmonary disease, including obstructive pulmonary disease, cor pulmonale, tuberculosis, and asthma * systemic disease (e.g. endocrinopathies, liver or kidney failure, myxedema, hypothyroidism, addison's disease, autoimmune disease) * current alcohol or sedative drug dependence * pregnant or breast feeding * currently receiving treatment for opioid dependence * known phobia of injections

Keywords: behavioral economics drug self administration opioid
eyebox concussion study and registry

Conditions: Concussion, Brain; Mild Traumatic Brain Injury

Summary: the objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mtbi and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of concussion.


Eligibility criteria:
inclusion criteria: 1. provide written informed consent or assent along with guardian consent. 2. have sustained a suspected direct or indirect force to the head with or without documented loss of consciousness, memory loss, alteration in consciousness or neurologic deficits. only individuals presenting for initial evaluation of concussion may be enrolled, however longitudinal assessments may be conducted on enrolled subjects. 3. have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking. exclusion criteria: 1. have penetrating trauma. 2. have had a conventional head ct or mri demonstrating evidence of structural brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read). 3. either of the following conditions, immediately related to the incident head trauma: loss of consciousness exceeding 30 minutes or best available gcs score less than 13 within 24 hours. 4. be blind (no light perception), have missing or non-functional eyes. 5. be unable to open their eyes. 6. have a history of unresolved strabismus, diplopia, amblyopia. 7. have a history of unresolved cranial nerve iii, iv, or vi palsy. 8. have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption. 9. have a history of extensive prior eye surgery (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or lasik are not exclusions) or scarring. 10. have a prior history of unresolved ocular-motor dysfunctions. 11. be intoxicated.
effects of heparin on arteriovenous fistula patency

Conditions: Arteriovenous Fistula

Summary: arteriovenous fistula (avf) is now the optimal method of obtaining vascular access for dialysis. measures such as systemic anticoagulation have been proposed as means of increasing patency rates but enough evidence does not exist to support their use. the investigators aimed to evaluate the efficacy of preoperative heparin injection on patency of avf during the first 24 hours after surgery and to determine whether such measure can be used to prevent early thrombosis of the vascular access.

the study was carried out on patients admitted to shohada-e-tajrish hospital for permanent vascular access placement since april 2011 through september 2012. the exclusion criteria consisted of having a contraindication of administration of anticuagulant agent. 150 patients were enrolled in the study. all patients were operated on by a single surgeon (dr mozafar. the non dominant upper extremity (mostly the left arm) was generally used unless unfavorable vasculature or previous fistula placement changed the preference. the anastomosis technique was either end-to-side or side-to-side using a number 6.0 prolene suture. 75 patients were randomly assigned to receive 100units/kg of heparin after dissection prior to anastomosis while the other 75 received no intraoperative heparin injection. auscultation of bruit and palpation of thrill was used to assess arteriovenous fistula patency in the first 24 hours after avf placement. data analysis was performed using spss v.20. a p-value of less than 0.05 was considered as statistically significant. bivariate analysis in the form of chi-square tests, t-test and fischer's exact test were calculated. patient enrollment was voluntary and no costs were imposed on the patients. the study protocol was in accordance with 1975 declaration of helsinki.

Eligibility criteria:
inclusion criteria: * chronic kidney disease, in need of avf placement exclusion criteria: * contraindications for anticoagulant therapy

Keywords: heparin
sipuleucel-t as neoadjuvant treatment in prostate cancer

Conditions: Prostate Cancer

Summary: this is an open label, phase 2 trial of immunotherapy with sipuleucel-t as neoadjuvant treatment in men with localized prostate cancer.

this is a single center, open label, phase 2 study. subjects will be treated with 3 infusions of sipuleucel-t prior to a scheduled radical prostatectomy (rp) surgery. to assess the immune response following treatment with sipuleucel-t, tissue from the prostatectomy specimen will be compared with tissue from the core biopsy specimen obtained prior to treatment with sipuleucel t. following rp, subjects will be randomized to receive either a booster infusion of sipuleucel t or no further treatment with sipuleucel-t (i.e., booster: no booster).

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the prostate. * subject is scheduled for rp as the initial therapy for localized prostate cancer. * subject is ≥ 18 years of age. * subject has an eastern cooperative oncology group (ecog) performance status of 0 or 1. * subject has adequate hematologic, renal, and liver function. exclusion criteria: * subject has any evidence of metastasis. * subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening. * subject has received prior radiation therapy or chemotherapy for prostate cancer. * subject has received systemic steroid therapy within 14 days. * subject has a history of stage iii or greater cancer, excluding prostate cancer. * subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening. * subjects with a history of stage i or ii cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.