Kornimate/medical-research-clean huggingface dataset:
a study of alvimopan for the management of postoperative ileus in participants undergoing radical cystectomy

Conditions: Postoperative Ileus

Summary: this study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. secondary objectives of the study are: * to evaluate the effect of alvimopan on hospital length of stay * to evaluate the effect of alvimopan on prespecified postoperative ileus (poi)-related morbidities * to evaluate the overall and cardiovascular safety of alvimopan


Eligibility criteria:
inclusion criteria: * are either male or female at least 18 years of age * are scheduled for radical cystectomy * are scheduled to receive postoperative pain management with intravenous participant-controlled opioid analgesics exclusion criteria: * are scheduled for a partial cystectomy * have taken more than 3 doses of opioids (oral or parenteral) within 7 days before the day of surgery

Keywords: ileus poi
effects of an overground propulsion neuroprosthesis in community-dwelling individuals after stroke

Conditions: Stroke

Summary: this interventional study evaluates the effects of an overground propulsion neuroprosthesis that delivers adaptive neurostimulation assistance to the paretic plantarflexors and dorsiflexors of people post-stroke. individuals with chronic post-stroke hemiparesis will walk with and without the neuroprosthesis overground and on a treadmill. the goal of the study is to understand how adaptive neurostimulation delivered by the neuroprosthesis affects clinical and biomechanical measures of walking function in order to guide future rehabilitation approaches for restoring walking ability after stroke.

this interventional study evaluates the effects of an overground propulsion neuroprosthesis that delivers adaptive neurostimulation assistance to the paretic plantarflexors and dorsiflexors of people post-stroke. individuals with chronic post-stroke hemiparesis will walk with and without the neuroprosthesis overground and on a treadmill. the goal of the study is to understand how adaptive neurostimulation delivered by the neuroprosthesis affects clinical and biomechanical measures of walking function in order to guide future rehabilitation approaches for restoring walking ability after stroke. ten individuals with chronic post-stroke hemiparesis will complete a single session of walking with and without the neuroprosthesis. study evaluations will be conducted both before and after the session, without the neuroprosthesis active, and during the neuroprosthesis-supported walking.

Eligibility criteria:
inclusion criteria: * diagnosis of a stroke event occurring at least 6 months ago * observable gait deficits * independent ambulation for at least 30 meters (using an assistive device as needed but without a rigid brace or ankle foot orthosis) * passive ankle dorsiflexion range of motion to neutral with the knee extended * ability to follow a 3-step command * resting heart rate between 40-100 bpm * resting blood pressure between 90/60 and 170/90 mmhg * nih stroke scale question 1b score \> 1 and question 1c score \> 0 * hipaa authorization to allow communication with healthcare provider * medical clearance by a physician exclusion criteria: * severe aphasia or inability to communicate with investigators * neglect or hemianopia * serious comorbidities that may interfere with ability to participate in the research (e.g. musculoskeletal, cardiovascular, pulmonary) * pacemakers or similar electrical implants that could be affected by electrical stimulation * metal implants directly under the stimulation sites * pressure ulcers or skin wounds located near human-device interface sites * more than 2 unexplained falls in the previous month

Keywords: gait rehabilitation functional electrical stimulation (fes) stroke exosuit propulsion neuroprosthesis
intra-stent tissue evaluation within bms and des > 3 years since implantation

Conditions: In-stent Coronary Artery Restenosis

Summary: this study aims to test the hypothesis that plaque composition differs within a stent between bare metal stents and drug eluting stents (des). it is possible that a difference in plaque composition seen within a stent may be contributory to the late thrombotic events seen more frequently with des.


Eligibility criteria:
inclusion criteria: * subject \> 18 years of age; * subject, male or female, who underwent des or bms implantation in a native coronary vessel more than 3 year ago; * subject is scheduled for a diagnostic coronary or interventional procedure; * subject is willing to sign the informed consent. exclusion criteria: * subject requires emergency catheterization; * subject has an acute myocardial infarction defined as anginal symptoms with st-elevation on the ekg or creatine kinase-mb elevation \>3times the upper limit of normal; * angiographic evidence of ≥ 70% stenosis within the target stent (visual estimate); * subject presented with cardiogenic shock; * subject has angiographically confirmed thrombus in the target coronary artery; * subject has a complex lesion not amenable to the ivus/vh catheters and/or oct catheters passing the stented segment; * subject has a contraindication to angiography/ivus/oct; * female subject is pregnant or lactating; * subject has life threatening comorbid conditions for which the investigator feels the subject should not be enrolled
ultrasound of the inferior vena cava in the prevention of hypotension after induction of general anesthesia

Conditions: Elderly Patients Undergoing Elective Non-cardiac Surgery

Summary: based on the preoperative ultrasound detection of various parametric indicators of the inferior vena cava cross-section, including the ratio of the inferior vena cava's long and short axes, cross-sectional area and circumference during two-dimensional and three-dimensional imaging, as well as the changes in respiratory variability of each parameter, we explored the predictive value of ivc ultrasound indicator parameters on hypotension after induction of general anesthesia in elderly patients undergoing elective non-cardiac surgery, screened the sensitive indicators, and calculated the cut-off values.


Eligibility criteria:
inclusion criteria: * elderly patients undergoing elective non-cardiac surgery under general anesthesia; * age 65-85 years old; * body mass index (bmi) 18-28 kg/m2; * american society of anesthesiologists (asa) class i-iii. exclusion criteria: * patient refusal or lack of cooperation; * inability to communicate properly; * severe sinus bradycardia, pacemaker implantation, atrioventricular block, and atrial fibrillation; * presence of severe hepatic and renal function abnormalities; * preoperative cardiac ultrasound suggesting lvef \<50%; * tricuspid valve displacement \<16 mm by preoperative cardiac ultrasound; * chronic obstructive pulmonary disease; * pulmonary hypertension; * administration of drugs that inhibit the renin-angiotensin-aldosterone system; * possibility of a difficult airway.

Keywords: hypotension general anesthesia inferior vena cava
internet diabetes self-management workshop

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine of the effectiveness of an internet based diabetes self-management workshop for people with type ii diabetes. half of the people who complete the workshop will be invited to continue their education by participating in a email discussion group. thus, we will be able to learn both the efficacy of the original program as well as its efficacy when reinforced by the discussion group. diabetes is a disease that must be managed day by day by the individual with the disease. although we know a great deal about the self-management of type ii diabetes, most self-management is less than optimal. in addition, most people with diabetes do not have an opportunity to participate in formal diabetes education. this study will determine if an internet delivered educational workshop will help people with diabetes manage their disease. thus we will be measuring changes in behaviors, changes in symptoms and changes in hba1c, blood pressure, cholesterol, and weight. if successful the workshop will serve as a prototype for internet diabetes education.


Eligibility criteria:
inclusion criteria::- diabetes type 2 * have internet access and email address * live in the united states * 18 years of age or older exclusion criteria:- previous participation in similar online or community-based self-management program * active treatment for cancer * pregnant
effectiveness and safety of early treatment with infliximab for hip arthritis associated with ankylosing spondylitis (as) (p06451)

Conditions: Ankylosing Spondylitis

Summary: this trial is designed to measure improvement of hip involvement in patients with ankylosing spondylitis (as) after receiving 4 doses of infliximab. participants will receive infliximab 5 mg/kg (as an intravenous perfusion over a period of 2 hours) at weeks 0, 2, 6, and 14, consistent with the approved dosing regimen described in the label. participants will be evaluated for hip pain, functional capacity and stiffness before and after 14 weeks (4 doses) of treatment. further treatment after 4 doses is based on standard clinical practice as determined by the trial site.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * ankylosing spondylitis (as) diagnosis * have all 3 of the following: * presence of hip pain (nocturnal inflammatory pain) * limitation of hip mobility * patient's global assessment visual analog scale (0-10 cm) ≥4 cm. * inadequate response or intolerance to non-steroidal anti-inflammatory drugs (nsaids) * eligible to be treated with infliximab (remicade®) exclusion criteria: * causes of coaxalgia other than coxitis of as, demonstrated by images or laboratory tests * women who are pregnant or nursing or plan to nurse or become pregnant * serious infections like sepsis, abscesses. * history of or current certain infections * history of or current certain medical conditions

Keywords: ankylosing spondylitis hip arthritis infliximab
effect of changing physiological conditions on myogenic oscillations: pilot study

Conditions: Vascular Diseases

Summary: spontaneous myogenic oscillations will be studied under general anesthesia using finger photoplethysmography. this pilot study will explore potential physiological conditions that will effect the amplitude and/or frequency of myogenic oscillations.

this is a single center, nonrandomized, nonblinded, interventional clinical pilot research study that plans to enroll 40 patients. study will be conducted while subjects are under general anesthesia. myogenic oscillations will be measured using finger photoplethysmography. changes in the amplitude and/or frequency of these oscillations will be analyzed in response to the interventions. arterial blood pressure will be recorded to verify the efficacy of the interventions. six different interventions that will either lower or increase blood pressure will be applied to the subjects. each subject will receive 1 or 2 of the six interventions. each of the 6 interventions will be applied to 8 subject. the interventions that the subject will not be randomized. they will be determined by the subjects blood pressure immediately before the intervention to guarantee that the blood pressure manipulations are within a safe range. data will be analyzed offline using matlab.

Eligibility criteria:
inclusion criteria: 1. over 18 yrs of age 2. undergoing surgery in moffitt-long operating rooms 3. receiving general anesthesia 4. will have an intra-arterial catheter for clinical purposes 5. able to consent in english exclusion criteria: 1. under 18 years of age 2. unable to provide informed consent 3. pregnancy
rehabilitation after rotator cuff repair

Conditions: Rotator Cuff Injury

Summary: a new postoperative regimen with a new bandage technique after surgery results in a better shoulder function and quality of life after surgery - than traditional postoperative regimen with shoulder lock and abductor cushion.

a new postoperative regimen , with a new bandage technique with shorter immobilization time and without shoulder lock, is supposed to results in a better shoulder function 6 and 12 months after surgery. function is measured by constant score, pain with vas and quality of life with eq5d, 3 and 12 months after surgery. the two treatment groups are compared.

Eligibility criteria:
inclusion criteria: * planned shoulder surgery, rotator cuff repair exclusion criteria: * not swedish speaking * reoperation

Keywords: shoulder surgery rotator cuff injury rehabilitation function pain quality of life
double-blind, dose-escalation study of idx184 in chronic hepatitis c treatment-naïve subjects

Conditions: Chronic Hepatitis C (HCV)

Summary: this is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug idx184 given for 3 days in treatment-naive hcv genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.


Eligibility criteria:
inclusion criteria: 1. 18-65 years old 2. subject of childbearing potential must agree to use a consistent form of an acceptable double-barrier method of birth control. 3. plasma hcv rna ≥ 5 log10 iu/ml 4. hcv genotype 1 exclusion criteria: 1. received prior antiviral treatment for hepatitis c infection 2. subject is pregnant or breastfeeding 3. body mass index (bmi) \> 32 4. currently abusing alcohol or illicit drugs 5. currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction 6. co-infected with hepatitis b virus (hbv, hbsag positive) and/or human immunodeficiency virus (hiv)

Keywords: hepatitis c, hcv, treatment-naive
assessment of v0018 1.5 mg effect on craving

Conditions: Smoking

Summary: the purpose of this study is to evaluate the reduction of craving after administration of v0018 1.5 mg compared to placebo in healthy moderately dependent smokers.


Eligibility criteria:
inclusion criteria: * male and female aged 18 to 64 years * smoking ≥ 10 cigarettes/day and \< 20 cigarettes/day continuously for the last two years * with a first cigarette smoked within 30 min after waking * not currently in the process of quitting smoking exclusion criteria: related to pathologies * current or recurrent buccal lesions which, in the opinion of the investigator, would interfere with the assessment of the different parameters * hyposalivation or asialia * intolerance to lactose, or any pathology that could cause endogenous production of carbon monoxide (co) related to treatments * use of antidepressants within the last three months * use of sedatives, hypnotics, tranquilizers or any other addictive agents within the last 3 months * routine use of tobacco other than cigarettes * regular use for more than one week of any treatment for smoking cessation (gum, patch, inhaler, lozenge, tablet, bupropion, varenicline) and other smokeless tobacco products (including e-cigarettes) within three months * history of hypersensitivity to nicotine, peanut, soya or to any of the excipients of study treatment * intolerance to fructose * history of phenylketonuria (aspartame) for women of childbearing potential: * is pregnant or in post-partum period or a nursing mother

Keywords: nicotine replacement therapy craving healthy moderately dependant smokers
revealing engagement dynamics among diabetic kidney disease patients

Conditions: Diabetic Kidney Disease

Summary: the study intends to investigate the personal experiences of diabetic kidney disease patients who take part in a separate clinical study including a specific medication intervention. the major focus will be on closely following individuals' rates of trial completion and withdrawal. the data collected from this study will help improve future outcomes for all diabetic kidney disease as well as those in under-represented demographic groups.


Eligibility criteria:
inclusion criteria: * patients diagnosed with diabetic kidney disease * aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed * subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination. exclusion criteria: * refusal of consent * women of childbearing potential without a negative pregnancy test; or women who are lactating. * any serious and/or unstable pre-existing medical disorders

Keywords: diabetic kidney disease
pfo access registry

Conditions: Patent Foramen Ovale; Stroke

Summary: closure of patent foramen ovale with the amplatzer® pfo occluder in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.

the primary objective of the pfo access registry is to allow access to the amplatzer pfo occluder in subjects with a pfo who have already experienced at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional drug therapy.

Eligibility criteria:
inclusion criteria: patent foramen ovale (pfo); recurrent cryptogenic stroke; failed antiplatelet/anticoagulant therapy exclusion criteria: international normalized ration (inr) outside of 2-3; intracardiac thrombus (subjects may be enrolled after resolution of thrombus)

Keywords: pfo stroke
laparoscopic sacropexy and vaginal natural orifice transluminal endoscopic surgery shull suspension comparison trial

Conditions: Pelvic Organ Prolapse

Summary: this is a prospective, randomized multicenter study whose objective is to compare two surgical techniques routinely used at our center for the correction of pelvic organ prolapse (laparoscopic cervicosacropexis versus colposuspension sec. shull using v-notes).

patients with pelvic organ prolapse with a stage greater than or equal to stage 2 for the apical compartment who are candidates for surgical correction will be randomized and assigned to one of two treatment groups. the aim is to compare the anatomical, surgical and anesthesiological outcomes between these two surgical techniques, both of which are commonly used in clinical practice for the correction of this type of prolapse.

Eligibility criteria:
inclusion criteria: * consecutive women referred to one of the participating centers with symptomatic stage 2 or greater (point c≥ -1 pelvic organ prolapse quantification pop-q) apical prolapse (uterovaginal) with or without anterior and posterior compartment prolapse will be eligible for inclusion (criteria for which patients in clinical practice are candidates for one of the two interventions under study) exclusion criteria: * age \ 30, * previous hysterectomy, * inability to comprehend questionnaires, to give informed consent and to return for review, * unable to undergo general anesthesia, * prior laparoscopic prolapse repair or vaginal mesh prolapse procedure, * desire for future pregnancy or current pregnancy diagnosis * severe respiratory comorbidity, * asa iii patients, * need for concomitant anti-incontinence procedure.
incidence, risk factor, treatment and overall survival of locally recurrent rectal cancer

Conditions: Rectal Neoplasms; Neoplasm Recurrence, Local

Summary: data on disease recurrence was collected for all primary rectal cancer patients diagnosed in the netherlands over the first six months of 2015. three-year cumulative incidence, risk factors, treatment and three-year os of locally recurrent rectal cancer were determined.


Eligibility criteria:
inclusion criteria: * histologically confirmed stage i-iii primary rectal carcinoma; * diagnosed between january 1st and june 30th of 2015; * tme resection of primary rectal carcinoma. exclusion criteria: * neuroendocrine tumor morphology;
suicide assessment and feasible evidence-based treatments for youth living with hiv in lilongwe

Conditions: HIV; Suicide

Summary: the overall aim of this study is to determine the feasibility, fidelity, acceptability, and preliminary effectiveness of the friendship bench +safety planning intervention in reducing suicidal ideation and behaviors (sibs) and improving hiv engagement amongst adolescents living with hiv (alwh) when compared to augmented usual care.

this project aims to evaluate the feasibility, acceptability, fidelity, and preliminary effectiveness of the enhanced friendship bench+safety planning (fb+sp) intervention model. we will enroll 60 depressed alwh who report suicidality from four facilities in lilongwe, malawi, and randomize them 1:1 to the enhanced fb+sp model or augmented usual care. this pilot trial is a step toward our long-term goal of generating and implementing an evidence-based model to prevent suicide in malawi amongst alwh by enhancing the capacity of the health system to identify suicidality and provide evidence-based care. information gathered in this proposal will be used to develop a subsequent randomized control trial.

Eligibility criteria:
inclusion criteria: * age 13-19 * diagnosed with hiv * report current or historical suicidal ideation and behaviors (sibs) on question 9 of the patient health questionnaire modified for adolescents (phq-9-a) and the ask suicide-screening questionnaire (asq) * living in the clinic's catchment area with intention to remain for more than 1 year * willing to provide consent (age 18+ or 16-17 years old and married and thereby considered emancipated minors per malawi law) or assent with parental consent (age 13-17). exclusion criteria: * refuse to participate * refuse to be audio-taped for in-depth interviews

Keywords: hiv suicide suicidal ideation
study of dietary intervention under 100 mmol in heart failure

Conditions: Heart Failure

Summary: this study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic hf patients.


Eligibility criteria:
inclusion criteria: * patients will be recruited from each research center if they are 18 years or older, with confirmed diagnosis of heart failure (including both those with a reduced and preserved systolic function), nyha ii-iv, and willing to sign informed consent. exclusion criteria: * subjects will be excluded if they have severe hyponatremia (serum sodium \<130 mmol/l) * renal failure (a glomerular filtration rate \< 30 ml/min) * uncontrolled thyroid disorders * hepatic failure * implantable cardiac device (icd or crt) or myocardial revascularization procedures (coronary angioplasty and/or surgical revascularization) in the previous 3 months * uncontrolled atrial fibrillation or recurrent ventricular arrhythmias * malignancy, or with moderate-severe dementia. * patients will be excluded if, in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.

Keywords: patients with stable heart failure