Kornimate/medical-research-clean huggingface dataset:
fractional flow reserve to determine atherosclerosis renovascular hypertension stenting

Conditions: Renal Artery Stenosis Atherosclerotic; Secondary Hypertension Renal Arterial

Summary: although randomized trials have demonstrated there is no benefit of renal-artery stenting in addition to medical therapy for patients with atherosclerosis renal artery stenosis, many patients indeed gained benefit in daily practices after stenting, such as reduction in blood pressure and recovery in renal functions. one important gap is that there is no universal standard to determine whether to stent in these patients. fraction flow reserve (ffr) has been studied for many year in chronic coronary heart disease and ffr-guided revascularization strategy is known to be better than both angiography-guided revascularization and medication alone. the goal of this clinical trial is to learn whether fraction flow reserve (ffr) is appropriate to determine stenting in hypertension patients with atherosclerosis renal artery stenosis. the main questions it aims to answer are: * is it appropriate to use ffr to determine whether or not stenting for hypertension patients with atherosclerosis renal artery stenosis? * to provide detailed data supporting design of further trial, such as sample size calculating, cut-off value for ffr in renal artery stenosis, etc. participants met the inclusive/exclusive criteria will be randomized to stenting or not in the renal artery, then hyperemic ffr induced by dopamine will be measured in all participants. if ffr is ≥0.80, randomization will be applied. if ffr is \<0.80, randomization will be ignored, and stenting will be performed as planned. the blood pressure and anti-hypertensive medications will be compared before and 3 months after the procedure based on ambulatory blood pressure monitoring, all participants will be followed up for 1 year.


Eligibility criteria:
inclusion criteria: * with recorded hypertension, and the blood pressure is not controlled (sbp ≥140mmhg and/or dbp ≥90mmhg) on 2 or more classes of anti-hypertensive drugs; * evidence of renal artery stenosis and undergoing renal artery angiography; * able to follow the study protocol and provide informed consent; * renal artery angiography shows at least 1 main artery with stenosis of 50%-90%, and the diameter is ≥ 4.0mm. exclusion criteria: * sbp ≥200mmhg and/or dbp ≥120mmhg at the day or randomization; * fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis; * pregnancy or unknow pregnancy status in female of childbearing potential; * participation in any drug or device trial during the study period; * any stroke/tia, or with ≥70% stenosis of carotid artery; * any major surgery, myocardial infarction or interventional therapy 30 days prior to study entry; * lvef \<30%; * comorbid condition causing life expectancy ≤1 year; * allergy to contrast or any of the following: aspirin, clopidogrel; * previous kidney transplant; * previous renal artery bypass surgery or stent intervention; * kidney size less than 8 cm measured by ultrasound; * local lab serum cr \>3.0 mg/dl (265.2μmol/l) on the day of randomization; * reference vessel size \ 8 mm.
evaluation of serum chemokines for patients undergoing treatment with boceprevir.

Conditions: Hepatitis C

Summary: the purpose of the study is to determine differences in levels of serum chemokines from patients undergoing treatment with boceprevir. the aim is to determine if non-responders have significantly different levels of chemokines than responders.

patients undergoing standard of care at the unc liver center are consented for collection of an additional serum sample under the unc liver center serum and tissue bank study. these samples will be used to analyze differences in serum chemokines across responders and non-responders.

Eligibility criteria:
inclusion criteria: * all adult patients (age 18 or older) treated with an antiviral hepatitis c treatment regimen that includes boceprevir. exclusion criteria: * inability to provide informed consent for a serum sample enrolled in the university of north carolina liver center serum bank. * no pre and post serum sample available within 6 months of the treatment period.

Keywords: hepatitis hepatitis c observational study biomarkers of treatment response
effect of advanced care at home vs. traditional brick-and-mortar hospital care in acutely ill adults: a randomized clinical trial

Conditions: The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute Hospitalization

Summary: the purpose of this study is to compare two care delivery models that are currently being implemented in routine practice settings. the findings from this study will inform future clinical decision making, such as which patients might be more suited for which care delivery model.


Eligibility criteria:
inclusion criteria: * adult patients, 18 years of age and older. * present to one of the participating hospitals. * have a chief complaint of one of the target diagnoses. * are within a certain geographical area (based on zip codes). * have a health insurance plan that covers ach services. * have the capacity to consent or could assent with the consent of a health care proxy who is physically present. exclusion criteria: * the patient is not suitable for ach or inpatient hospital care based on: * being a nursing home patient; * on or requiring dialysis; * positive for covid-19; * having discharge order; * requiring intensive care unit (icu) level of care; * history of drug abuse. * patients will also need to meet the clinical stability criteria. * do not have the capacity to consent or assent with the assistance of a health care proxy.
modified enhanced recovery program in emergency surgery (meres)

Conditions: Acute Appendicitis; Acute Appendicitis With Rupture; Acute Appendicitis With Peritonitis; Acute Appendicitis Without Peritonitis

Summary: laparoscopic appendectomy (la) is a widespread surgical procedure. patients may develop considerable postoperative pain and dyspepsia resulting in prolong in-hospital stay. almost 10% of patients develop postoperative complications. enhanced recovery after surgery (eras) program has proven its effectiveness in elective surgery and can theoretically improve outcomes of la. to date there is no eras program for la. the aim of the study was to investigate the safety and efficacy of a modified eras protocol in la.

a modified eras (meras) protocol was investigated. the study is a prospective, randomized nonblinded. all patients underwent la. modified eras protocol included patient informing, limitation of drainage use; intraperitoneal anesthesia with long-acting anesthetics; low-pressure pneumoperitoneum; early mobilization and oral nutrition. pain level was assessed in rest using visual analogue scale (vas). the primary endpoint was postoperative length of stay (plos).

Eligibility criteria:
inclusion criteria: * patients with any stage of acute appendicitis except 3b according to gomes classification; * class i-ii surgical patients according to the classification of the american society of anesthesiologists (asa). exclusion criteria: * patient refusal to participate in the study or to sign the informed consent form; * language barrier; * transfer to the intensive care unit (icu) after surgery; * asa class ≥ iii; * conversion to open procedure; * appendicular mass found during laparoscopy; * gomes 3b appendicitis requiring immersion of the appendicular stump; * pregnancy.

Keywords: enhanced recovery fast-track appendectomy intraperitoneal anesthesia low pressure pneumoperitoneum
radiation therapy followed by surgery in high-risk, localized carcinoma of the prostate

Conditions: Prostate Cancer

Summary: the purpose of the study is to assess the safety of four different doses of radiation therapy followed by to surgery to remove prostate tumor.

patients in groups 1 and 2 will receive 39.6 gy and 45 gy (at 1.8 gy/fraction), respectively, to the whole pelvis. patients in groups 3 and 4 will receive 45 gy to the whole pelvis, followed by a boost to the prostate and periprostatic tissue, for total doses of 50.4 and 54 gy, respectively. the patients will then undergo radical prostatectomy between 4-8 weeks after completion of radiation.

Eligibility criteria:
inclusion criteria: * subjects must have biopsy-confirmed adenocarcinoma of the prostate. * subjects must have a negative bone scan. * subjects must have "high-risk" prostate cancer, defined as: a. psa \>/= 20, and/or b. gleason score (gs) \>/= 8, and/or c. clinical stage t3 disease per ajcc staging manual, 6th edition; or d. at least two out of three of the following: psa 10-19.9, gs = 7, or clinical stage = t2b / t2c. * subjects must be medically fit to undergo surgery as determined by treating urologist. * subjects must be under 70 years of age. * kps must be \>/= 80. * subjects must not have a synchronous primary tumor, or a previous cancer unless disease free for \>/= 5 years. * subjects must not have had prior pelvic radiation therapy, chemotherapy, or androgen deprivation. * subjects must freely sign informed consent to enroll in the study. exclusion criteria: * metastatic disease as demonstrated by bone scan, ct scan or mri of the pelvis, or chest x-ray. * pathologically documented positive pelvic lymph nodes. if pre-operative ct scan or mri (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial. * declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician. * history of prior pelvic radiation therapy. * history of androgen deprivation therapy or chemotherapy.

Keywords: radiation therapy
high vs low intensity virtual reality gait training in individuals with chronic stroke

Conditions: Stroke; Gait Disorders, Neurologic

Summary: the purpose of this pilot study is to investigate the feasibility of 1) providing virtual reality walking training using a custom developed setup able to be replicated in routine clinical practice and 2) combining the virtual reality training with high-intensity gait training.

this study will utilize a randomized-crossover design. following confirmation of eligibility and completion of baseline 1 testing, individuals will be randomized to receive up to 15 visits over approximately 5 weeks of either high or low intensity virtual reality gait training. following which, individuals will undergo post 1 testing to capture potential change in outcomes following the intervention. participants will then take at least a 4-week break before returning to complete baseline 2 testing and up 15 visits over 5 weeks of the alternative intervention before finally completing post 2 testing.

Eligibility criteria:
inclusion criteria: * unilateral deficits following stroke \> 6 months prior; however individuals \> 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until \> 6 months * age 18-85 years * weight \< 350 pounds * able to follow a 3-step command * able to ambulate with self-selected gait speeds between 0.01-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed * lower extremity fugl-meyer \< 34 * medical clearance to participate exclusion criteria: * evidence of cerebellar ataxia * uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities * currently participating in other physical therapy * \> 50 units of botox in the lower extremity or in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (afo) within the past three months. note that participants may be consented prior to 3 months post-injection; however, eligibility will be determined post 3 months. * unable to read \> 50% of the letters on the 20/70 line of the snellen chart with customary eye wear at a distance of 20 feet

Keywords: stroke gait rehabilitation high-intensity virtual reality
efficacy and safety of azimilide for the treatment of patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. the primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation. azimilide may have an effect on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal heart rhythms). this double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of azimilide compared with placebo in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to reduce atrial fibrillation. once this phase of the study is completed, a second phase with a different study design will be conducted. the second phase is an open-label follow-up phase to the study. this follow-up phase will continue to evaluate the long-term efficacy and safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.


Eligibility criteria:
inclusion criteria: * documented (12-lead ecg) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening * require the procedure of cardioversion (electric shock to correct heart rhythm) * in the investigator's opinion, be likely to maintain sinus rhythm after cardioversion. * be anticoagulated according to the recommendations of the study group on atrial fibrillation of the european society of cardiology guidelines. exclusion criteria: * previously unsuccessful electrical cardioversions * failed to respond to any class iii antiarrhythmic drugs * qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization
acute and chronic protective effects of peri-interventional administration of levosimendan in st elevation myocardial infarctions

Conditions: Myocardial Infarction; Outcome

Summary: in the proposed project the investigators want to assess whether the approach of the post-conditioning by levosimendan in patients with acute stemi is safe and reproducible, can be used with a positive influence on the outcomes with respect to myocardial damage, cardiac left ventricular remodeling, myocardial function, the occurrence of cardiac events and quality of life.

an acute st-elevation myocardial infarction (stemi) is a severe disease that triggers an adverse remodeling, and served in progressive heart failure with a case fatality rate of 50% in 5 years. the opening of the occluded vessel is the first and most important therapy, the reperfusion improved both the function as well as the long-term survival. at the same time, experimental and clinical studies show, however, that this reperfusion self-reinforced damage of the myocardium. an additional intervention in this trigger phase could not only reduce the acute damage, but long-term protective effects. both effects could be an approach for the calcium-sensitizer levosimendan in the animal model. so far, no clear effect on the remodeling and survive was demonstrated after myocardial infarction in the clinic. this could be mainly due to the delayed application in relation to the reperfusion and on the selection of suitable methods for the presentation of the effects on myocardial structure and function. in the proposed project the investigators want to assess whether the approach of the post-conditioning by levosimendan in patients with acute stemi is safe and reproducible, can be used with a positive influence on the outcomes with respect to myocardial damage, cardiac left ventricular remodeling, myocardial function, the occurrence of cardiac events and quality of life.

Eligibility criteria:
inclusion criteria: * stemi of the anterior wall \< 6 hrs * capacity to consent exclusion criteria: * previous myocardial infarction or bypass surgery * relevant vitium * stemi of the posterior wall * any contraindications to mri * unstable hemodynamics (hypotension, catecholamine therapy, severe arrhythmia), -respiratory failure * onset of symptoms more than 6 hours.
suicidal behavior in patients diagnosed with bipolar disorder

Conditions: Depression; Alcoholism; Drug Abuse

Summary: the purpose of this study is to learn the environmental and psychological factors that impact suicidality in patients diagnosed with bipolar disorder. additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program.

the purpose of this study is to learn the environmental and psychological factors that impact suicidality in patients with bipolar disorder. additionally, the study aims to identify treatments to reduce the suicidal behavior and improve quality of life through a 6-week group-based intervention program. groups will include topics such as interpersonal/social rhythm and mindfulness interventions, as well as interventions focused on understanding and changing thoughts to better cope with bipolar depression.

Eligibility criteria:
inclusion criteria: * english speaking * diagnosis of bipolar disorder (bd) * able to provide written informed consent exclusion criteria: * cognitive impairments * acutely psychotic * medically unstable * history of schizophrenia spectrum disorder * history of mood incongruent psychotic symptoms * history of primary substance disorder * history of primary organic disease and/or dementia

Keywords: psychology
exercise intervention in primary open-angle glaucoma

Conditions: Glaucoma, Open-Angle; Glaucoma

Summary: eye-fit is a randomized clinical trial with a two-arm parallel design aimed at assessing the impact of performing a structured and supervised physical training program on the different variables associated with glaucoma progression in pharmacologically treated primary open angle glaucoma patients. this intervention will include a supervised 24-weeks concurrent (endurance + resistance) training program comparing its influence to the standard care.

there are claims that more physically active individuals are less likely to glaucoma onset and progression. however, to date, there is not a single randomized controlled clinical trial assessing the impact of performing a structured and supervised physical training program on glaucoma progression. a randomized controlled clinical trial with a two-arm parallel design will be used to determine the chronic effects of a 24-weeks concurrent (endurance + resistance) training program in comparison to a control group (no training prescribed) on the ocular function and physical fitness of primary open angle glaucoma patients. participants will be randomly divided in one of the two groups (experimental or control \[wait-list\]), while ocular function and physical fitness will be assessed before and after the intervention by researchers blinded to the group allocation of each participant. in addition, primary open angle glaucoma patients will be subdivided according to their medical treatment in two groups (prostaglandin analogues and combination of prostaglandin analogue and beta-blockers). therefore, four groups will be considered in this clinical trial. the results of the eye-fit clinical trial will provide novel information on the influence of exercise on different markers of glaucoma, and may help to reduce the clinical, economic and social burden of this disease.

Eligibility criteria:
inclusion criteria: * have an age between 50 and 70 years old * primary open angle glaucoma diagnosis based on objective criteria (i.e., glaucomatous optic nerve head changes and visual field defects consistent with glaucoma, after the exclusion of other possible causes). * no have undergone any surgical intervention for glaucoma treatment * be medically treated with prostaglandin analogues or with a combination of prostaglandin analogue and beta-blockers exclusion criteria: * have an scheduled surgery for the following 6 months * have a sufficient level of mobility to perform supervised physical exercise * suffer any disease that prevent the practice of physical exercise

Keywords: exercise multidisciplinary intervention eye care
head-up tilt sleeping to alleviate orthostatic hypotension, supine hypertension and nocturia in parkinson's disease

Conditions: Parkinson Disease; Parkinsonism

Summary: autonomic dysfunction is common and often underrecognized in parkinson's disease (pd). orthostatic hypotension (oh) affects up to a third of pd patients and often coincides with supine hypertension. this co-occurrence complicates pharmacological treatment as treatment of one can negatively affect the other. head-up tilt sleeping (huts) could improve both. this phase ii randomized controlled trial (rct) aims to investigate the efficacy and tolerability of this understudied intervention, leading to optimal implementation strategies.

autonomic dysfunction is common and often underrecognized in parkinson's disease (pd). orthostatic hypotension (oh) affects up to a third of pd patients and about half of them also exhibit supine hypertension. in current clinical practice both are undertreated. the common co-occurrence of oh and supine hypertension complicates pharmacological treatment as improvement of one can be accomplished only at the expense of the other. head-up tilt sleeping (huts) is the only intervention known that could improve both. the concept of huts is based on several small-scale observational studies and expert opinion. although huts has been proposed as an effective and even first choice non-pharmacological treatment for oh for over three decades, it is often not advised to patients because of lack of evidence on its effectiveness and on how to implement it. the heads-up trial is a multicenter home-based double-blind phase ii rct. the study aims to investigate the efficacy and tolerability of huts, leading to optimal implementation strategies of huts to treat orthostatic hypotension and supine hypertension.

Eligibility criteria:
inclusion criteria: * orthostatic hypotension defined as a systolic bp decrease of ≥20 mmhg, or a diastolic decrease of ≥10 mmhg, within 3 min after changing from a supine to standing position or mean standing bp of ≤75 mmhg (marker for symptomatic orthostatic hypotension). in patients with supine hypertension, a decrease in systolic bp of ≥ 30 mmhg is required; * orthostatic intolerance: direct complaints (dizziness, blurry vision, etc.) and/or indirect signs (falls or freezing episodes that relate to postural challenge); * supine hypertension defined as a systolic bp of ≥140 mmhg, and/or diastolic of ≥90 mmhg, after 5 min of supine rest; * idiopathic pd or parkinsonism (multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, vascular parkinsonism and lewy body dementia); * ability to walk (with or without a walking aid), as subjectively determined by the researcher; * stable medication regimens for orthostatic hypotension and supine hypertension during the trial; exclusion criteria: * inability to follow instructions and complete questionnaires, as assessed by the researcher;

Keywords: parkinson's disease orthostatic hypotension supine hypertension autonomic dysfunction