Kornimate/medical-research-clean huggingface dataset:
project 3: achieve- chd

Conditions: Coronary Heart Disease

Summary: this project is part of the achieve greater (addressing cardiometabolic health inequities by early prevention in the great lakes region) center (irb 100221mp2a), the purpose of which is to reduce cardiometabolic health disparities and downstream black-white lifespan inequality in two cities: detroit, michigan, and cleveland, ohio. the achieve greater center will involve three separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (htn, project 1), heart failure (hf, project 2) and coronary heart disease (chd, project 3), which drive downstream lifespan inequality. all three projects will involve the use of community health workers (chws) to deliver an evidence-based practice intervention program called pal2. all three projects will also utilize the pal2 implementation intervention (pal2-ii), which is a set of structured training and evaluation strategies designed to optimize chw competence and adherence (i.e., fidelity) to the pal2 intervention program. the present study is project 3 of the achieve greater center.


Eligibility criteria:
inclusion criteria: 1. 40 to 75 years of age 2. self-identified as black or african american 3. residence in the cleveland metro area 4. must have at least two of the following risk factors identified at a uh health fair screenings, with one risk factor being with sbp, a1c, or ldl: 1. bmi≥30 mg/dl 2. history of smoking 3. elevated blood pressure defined as sbp\>140 or dbp\>80 mmhg 4. hba1c≥5.7% 5. ldl≥130 5. able to complete a coronary artery calcium score test (cac) 6. willing and able to consent 7. willing to have a uh provider and uh care 8. currently insured for standard of care procedures exclusion criteria: 1. established documented cardiovascular disease (coronary artery disease, peripheral artery disease, myocardial infarction, stroke). 2. systolic blood pressure ≥ 180 mmhg or diastolic blood pressure ≥ 110 mmhg 3. lung disease requiring supplemental oxygen therapy 4. individuals receiving treatment for cancer related disease 5. pregnant or nursing mothers

Keywords: health disparities african american prevention coronary heart disease
combination therapy of bosentan and aerosolized iloprost in idiopathic pulmonary arterial hypertension (ipah)

Conditions: Hypertension

Summary: the purpose of this study is to test whether the addition of inhaled iloprost is safe and effective in patients with idiopathic pulmonary arterial hypertension who are already being treated with the endothelin receptor antagonist bosentan.


Eligibility criteria:
inclusion criteria: * ipah * \> 3 months treatment with bosentan * 6 minute walk distance 150 - 425 m exclusion criteria: * other forms of pulmonary hypertension * severe comorbidities * cotreatment with sildenafil or investigational drugs

Keywords: idiopathic pulmonary arterial hypertension
clinical significance and diagnosis of sarcopenia in cardiac patients

Conditions: Heart Failure With Preserved Ejection Fraction; Hypertension; Sarcopenic Obesity

Summary: obesity sarcopenia, characterized by the coexistence of excess fat and muscle mass reduction, may contribute to the pathophysiology of exercise intolerance in patients with heart failure with preserved ejection fraction (hfpef). the project will examine the impact of selected circulating mirnas on processes that may form the pathophysiological basis for hfpef development and obesity sarcopenia in correlation with biochemical markers, echocardiographic assessment and non-invasive assessment of hemodynamic parameters. in addition, the impact of ldl and hdl on these diseases will be assessed. determinations of selected adipokines and asymmetric dimethylarginine will also be carried out and their effects on the cardiovascular system will be assessed.


Eligibility criteria:
inclusion criteria: * control group: healthy volunteers * study groups: patients with hfpef. patients in which the results of bnp/nt-probnp did not confirm the diagnosis of hfpef were classified as hypertensive group. exclusion criteria: * coronary artery disease * unstable hypertension * heart failure class iv nyha * condition after percutaneous or surgical revascularization * pulmonary hypertension in echocardiography * obstructive or restrictive lung diseases * congenital heart disease * arrhythmias (including atrial fibrillation) * pacemaker or implantable cardioverter defibrillator * hyperthyroidism or hypothyroidism * pregnancy or lactation * hemodynamically significant acquired heart defects * cardiomyopathies * gfr \<60 ml/min/1.73 m2 * other medical conditions such as: cancer, significant anemia, diabetes, alcohol and drug abuse, chronic inflammatory diseases and other * the patient's inability to cooperate and / or give informed consent to participate in the study
relevance of reversible causes during ohca (rebecca study)

Conditions: Out-Of-Hospital Cardiac Arrest; Cardiopulmonary Arrest

Summary: management of the reversible causes in cardiac arrest is fundamental for successful treatment of out-of-hospital cardiac arrests. point-of-care diagnostics as prehospital emergency ultrasound, blood gas analysis and toxicological screening support the diagnostic process of evaluating potential reversible causes. digital tools provide support of a structured approach. this study aims to evaluate the frequency of reversible causes during ohca as well as specific interventions due to these findings. furthermore, cpr performance (hands-off, rosc, 30-day mortality) and cognitive load of the prehospital emergency physician will be investigated. in total 100 patients with ohca will be included in this study. identification of reversible causes will be performed upon a structured protocol using an interactive checklist. cognitive load of emergency physician as well as cpr parameter (frequency of reversible causes, hands-off, rosc, 30-day mortality) will be analysed.


Eligibility criteria:
inclusion criteria: * patients with prehospital cardiac arrest, where pocus, blood gas analysis as well as screening for intoxication can integrated in als rhythm without delay of life-saving treatment or transportation will be included. exclusion criteria: * patients will be excluded under the age of 18, or if pocus, blood gas analysis will lead to a delay of live-saving treatment or transportation. furthermore, pregnant patients will be excluded.

Keywords: intoxication prehospital pocus cpr sonography blood gas analysis cardiac arrest ohca reversible causes tele-support checklist prehospital emergency physician emergency medicine
effect of portal vein thrombosis on the prognosis of liver cirrhosis

Conditions: Liver Cirrhosis; Portal Vein; Venous Thrombosis; Varicose Veins; Hemorrhage

Summary: the prevalence of portal vein thrombosis (pvt) in patients with liver cirrhosis is 5-20%. current evidence regarding the effect of portal vein thrombosis on the prognosis of cirrhotic patients remains under debate. considering that pvt potentially elevates the portal pressure and thereby increase the risk of variceal bleeding, we focus on the patients with high-risk varices and variceal bleeding as the study population. thus, the main goals are to analyze the effect of pvt on the incidence of first variceal bleeding in patients without any prior bleeding history but with high-risk varices, the incidence of recurrent variceal bleeding in patients with a history of variceal bleeding, and the treatment failure rate of variceal bleeding in patients with acute variceal bleeding. certainly, the survival is also observed in all patients.


Eligibility criteria:
inclusion criteria: 1. a diagnosis of liver cirrhosis. 2. patients should be diagnosed with high-risk varices endoscopically, or a prior history of variceal bleeding, or an episode of acute variceal bleeding. 3. patients agreed to undergo endoscopy to evaluate the presence and severity of varices. 4. patients agreed to undergo contrast-enhanced ct scans to evaluate the portal vein patency. but if an abdominal contrast-enhanced ct scans was performed within 3 months after admission, it was not necessarily repeated. exclusion criteria: 1. non-cirrhotic patients. 2. malignancy. 3. contrast-enhanced ct scans were neither feasible nor available. 4. severe cardiopulmonary diseases. 5. severe infectious diseases. 6. pregnant or breastfeeding. 7. allergic to contrast agents. 8. poor adherence.

Keywords: prognosis
assessment of the invocell culture device when used for up to five-day incubation

Conditions: Infertility

Summary: the invocell culture device received de novo request for 3-day intravaginal incubation. the device is held in place with the intravaginal cavity by a retention device. the clinical study will assess the ability of a modified retention device to hold invocell in place during 5-day vaginal incubation as well as comfort and vaginal irritation as secondary endpoints.

this is a single center, open label non-comparative prospective trial to evaluate the retention of the invocell ivc with the retention device over the vaginal incubation period of up to 5 days. the purpose of this study is to assess the retention of the invocell ivc device with the retention device over the vaginal incubation period of up to 5 days. primary endpoint • retention of the invocell ivc device with the retention device over the vaginal incubation period of up to 5 days. secondary endpoint * comfort of the invocell ivc and retention device * vaginal tissue reactions during the vaginal incubation * optical clarity and the ability to visualize the embryos after the incubation

Eligibility criteria:
inclusion criteria: * have been informed about the study and have given their written consent. * patients 18 years to 42 years * women who are scheduled for an oocyte retrieval in anticipation of invocell ivf. exclusion criteria: * inability to read and speak english fluently * identified vaginal infection * recent pelvic surgery based on clinical history and physical examination. * history of toxic shock syndrome * inability to tolerate the placement or wearing of the invocell ivc or invocell retention device. * inability to tolerate a speculum examination * unwilling or unable to wear the invo retention (diaphragm) during the incubation. * unable or unwilling to sign informed consent or abide by study follow up assessment requirements.
comparison between infant flow sipap and noninvasive nava in the neonatal intensive care unit

Conditions: Respiratory Distress Syndrome

Summary: when babies are born premature, they often need help with their breathing. the equipment used to help them breathe is not very comfortable and they sometimes need to be put on a specialized breathing machine with a tube into their lungs. the breathing machine or ventilator can be damaging to the newborn's lungs and more damage can occur the longer the newborn stays on a ventilator leading to chronic lung disease later in their lives. a new device called neurally adjusted ventilatory assist or nava is available that the investigators believe may be more comfortable for the premature newborn and may help the baby come off breathing support sooner. when using this device, babies may not need to be put on a ventilator and can avoid the lung damage associated with the breathing tube and the ventilator. the objective of this pilot study is to compare this new breathing device called nava, to the equipment that is currently being used, called sipap, to support premature newborn's breathing after birth without a breathing tube. the investigators hope to show that with this new technology, premature newborns that are having a difficult time breathing, will come off breathing support sooner compared to the breathing machines that are currently being used. the hypothesis for this proposed study is that improved synchrony with noninvasive nava will decrease time spent on noninvasive ventilation and avoid intubation.


Eligibility criteria:
inclusion criteria: * infants born greater than or equal to 28+0 weeks and less than or equal to 31+6 weeks gestation * diagnosis of rds in the first 24 hours of life requiring respiratory support * parental consent obtained exclusion criteria: * infants with a major congenital anomaly * infants with pulmonary hypoplasia * infants known or suspected to have a neuromuscular disorder * infants less than 28+0 weeks ga * intubated infants that are likely to require continued mechanical ventilation * infants requiring vigorous resuscitation at birth, including chest compressions +/- cardiac medications
weight management demonstration project: health

Conditions: Weight Loss

Summary: the study investigated the effectiveness and cost-effectiveness of a cognitive and behavioral weight management program, complemented by an interactive web site and brief telephone coaching, implemented among tricare non-active-duty beneficiaries. a total of 1,755 participants from four midwestern states were randomized to one of three randomized controlled trial groups with increasing intervention intensity: mailed material and basic web access (rct1), plus an interactive web site (rct2), plus brief phone- and web-based coaching support from health lifestyle coaches (rct3). the study assessed changes in participants' weight, blood pressure, diet, and physical activity from baseline to 6, 12, and 15 to 18 months. analyses estimated overall cost savings and calculated the cost-effectiveness ratio of each randomized controlled trial compared with a "do-nothing" alternative as the cost per quality-adjusted life year.

lifestyle modification interventions that promote healthful eating habits and physical activity can be effective in producing weight losses of 4% to 9% of initial bodyweight. if maintained, this level of weight loss can reduce hypertension, high blood glucose, and elevated lipids. however, weight losses often plateau after 6 months, and weight regain begins after 12 months. accordingly, there is interest in interventions, such as web-based reinforcement and brief counseling to maintain weight loss over time and in the relative cost-effectiveness of program delivery modes. most obesity treatment programs focus on outcomes for individuals without assessing population-based cost savings. this study suggests that a broader perspective can help to identify the benefit of weight management in adult populations. accordingly, this study assessed the cost-effectiveness of a weight management program in a population of adults served by a large health care system-the tricare management activity (tma), the agency that manages the tricare health care benefits for active-duty service members, retired service members, their families, national guard/reserve members, and their families. the annual direct medical costs of overweight/obesity for beneficiaries enrolled in tricare prime are estimated to exceed $1.1 billion. this study investigated the effectiveness and cost-effectiveness of methods to deliver a cognitive-behavioral weight loss intervention.

Eligibility criteria:
inclusion criteria: * tricare prime non-active-duty beneficiaries * body mass index of 25 to 50 * living in 4 midwestern states (tricare region) exclusion criteria: * not able to engage in physical activity * pregnant * body mass index greater than 50 * body mass index less than 25 * human immunodeficiency virus infected * current cancer

Keywords: behavioral weight management intervention weight loss cost-effective analysis high blood pressure randomized clinical trial behavioral interventions physical activity dietary change obesity
the comparison of the analgesic efficacy and hemodynamic effects of paravertebral block compared with paravertebral and intercostal nerve block for thoracotomy in adults.

Conditions: Pain, Postoperative; Nerve Block; Thoracotomy

Summary: thoracotomy is a surgical procedure associated with severe post operative pain during the first day of surgery and is responsible for prolonged hospital stay, patient dissatisfaction and delayed return to normal activities along with increased morbidity and mortality. investigators intend to compare the efficacy of two analgesic interventions (continuous infusion of paravertebral block (pvb) after loading dose compared with intercostal nerve block and continuous infusion of pvb without loading dose) on postoperative thoracotomy pain. the results of this study will direct the investigators to find the best practice methods which will reduce the postoperative thoracotomy pain, the overall cost of pain management and length of patient's hospital stay.

objective to compare the safety, efficacy for pain relief and hemodynamic changes of two analgesic interventions(continuous infusion of paravertebral block (pvb) after loading dose compared with intercostal nerve block and continuous infusion of pvb without loading dose)

Eligibility criteria:
inclusion criteria: * all asa i-iv adult patients between the ages of 18-70 years scheduled for elective thoracotomy * either sex exclusion criteria: 1. neurological or psychiatric diseases 2. emergency procedures. 3. language barrier 4. patients under chronic treatment with opioids 5. patients with hypersensitivity to bupivacaine 6. coagulation disorders. 7. unwilling to participate. 8. patient previously involved in other studies
evaluation of mirtazapine and folic acid for schizophrenia:

Conditions: Schizophrenia

Summary: multicentre randomised double-blind, placebo-controlled 2x2 factorial trial investigating the effects of adding mirtazapine and folic acid to existing therapy for patients with schizophrenia

the combination of mirtazapine plus antipsychotic potentially offers considerable benefit for patients with schizophrenia. folic acid is a promising adjunctive therapy for schizophrenia that may also provide benefits for patients with other mental disorders. furthermore the effects of folic acid may be affected by genotype. the trial will investigate the effects of adding mirtazapine and the effects of adding folic acid to treatments for schizophrenia. at randomisation, patients will be separately randomised to mirtazapine or placebo and to folic acid or placebo. randomised, double-blind, placebo-controlled 2x2 factorial trial with 12-week follow-up.

Eligibility criteria:
inclusion criteria: 1. inpatients or outpatients age 18 to 70 years; 2. meet dsm-iv criteria for schizophrenia; 3. signed an informed consent form by patients or their legally acceptable representatives; 4. panss total score \>=60 and at least one item of p1, p2, p3, p5 or p6 \>=4 to ensure subject has current active psychotic symptoms - i.e. hallucinations, delusions, thought disorder; 5. subjects who are currently taking effective dose of antipsychotic; 6. women must agree to practice an effective method of birth control if they are sexually active before entry and throughout the study. exclusion criteria: 1. meet any other dsm-iv axis i disorders; 2. meet dsm-iv criteria for substance abuse or dependence; 3. have been treatment-resistant to 2 or more kinds of antipsychotics with sufficient dosage for at least 4 weeks, or require clozapine treatment, or have received clozapine treatment within 1 month prior to randomization; 4. subjects are actively suicidal or judged clinically to be at risk of serious suicidal or violent behavior in the opinion of the investigator; 5. have serious or unstable medical illness (e.g., cardiovascular disease, neurologic, hematologic, renal, hepatic, immunologic, endocrine, or other systemic illness), or have any clinically significant abnormality on laboratory test or ecg which indicate severe medical conditions; 6. have received electroconvulsive therapy within 28 days before randomization; 7. have received long acting antipsychotic within 1 treatment cycle before randomization; 8. have received antidepressant within 14 days, or have received maois within 4 weeks before randomization or require antidepressive treatment; 9. history of prostatic hypertrophy or dysuria; 10. history of narrow-angle glaucoma or elevation of intraocular pressure; 11. known or suspected history of allergy or have contradiction to mirtazapine or folic acid; 12. known have currently requirement of taking mirtazapine or folic acid; 13. women who are pregnant or nursing; 14. have previously completed or withdrawn from this study, or participated in a clinical trial of another drug within 30 days.

Keywords: mirtazapine folic acid schizophrenia
safety of vascugel treatment after creation of arteriovenous access for hemodialysis use

Conditions: Hemodialysis Access

Summary: vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an av graft or fistula for hemodialysis access.

randomized, double-blind, parallel group, phase i/ii clinical trial of vascugel™ treatment vs. gelfoam® in patients undergoing creation of an arteriovenous graft or fistula for hemodialysis access. all patients will undergo preoperative duplex ultrasound imaging and/or angiography (whatever is the standard of care at the research site) of the vein and artery to evaluate the optimal site for vascular access placement in the upper extremity. patients will be examined with doppler ultrasound or standard of care immediately after surgery to verify patency of the av graft or fistula. during the follow-up period, each patient will undergo a physical examination and imaging of the vascular access at specified intervals.

Eligibility criteria:
inclusion criteria: * adult male or female patients (ages of 18 to 89, inclusive) who are undergoing placement of an av graft or fistula for hemodialysis access exclusion criteria: * patient is currently on an active transplant list for a kidney from a deceased donor or is undergoing assessment and expects to be placed on the active transplant list within the next twenty-four weeks or expects to receive a living donor kidney within twenty-four weeks. * patient is expecting another solid organ transplant or a bone marrow transplant. * patient has had more than one access surgery (defined as a new access, not a revision) in the target limb. * patient is currently on chronic, systemic immunosuppressant medication other than locally or topically applied steroids.

Keywords: hemodialysis access arteriovenous graft arteriovenous fistula end stage renal disease
anemia in orthopedic surgery - determination of hb

Conditions: Anemia

Summary: anemia prevalence in orthopedic surgery is up to 30 %. identifying those patients prior to surgery and treating them would be ideal. different ways of determining hemoglobin levels are available. in this study classical laboratory determination, determination with hemocue® and rad-67™ will be performed to compare precision of those three methods as well as their correlation.


Eligibility criteria:
inclusion criteria: * age \> 18 years * scheduled for elective orthopedic surgery * written informed consent. exclusion criteria: • not able to speak the german language

Keywords: preoperative orthopedic surgery
dose optimization of caffeine for hie

Conditions: Hypoxic-Ischemic Encephalopathy

Summary: this is a phase ib, open-label, dose-validating and safety study of caffeine in neonates with hypoxic-ischemic encephalopathy (hie) undergoing therapeutic hypothermia.

in a previous phase i trial (nct03913221), the investigators characterized the pharmacokinetics (pk) of caffeine in the setting of hie and therapeutic hypothermia using a population pk model. this is an open-label study of caffeine citrate in neonates with hie to validate the population pk model and determine optimal dosing for hie.

Eligibility criteria:
inclusion criteria: * documented informed consent from parent or guardian * ≥ 36 weeks gestational age at birth * receiving therapeutic hypothermia for a diagnosis of hie * intravenous (iv) access * postnatal age \< 24 hours exclusion criteria: * receiving \> 1 anti-epileptic drug for seizures * sustained (\>4 hours) heart rate \> 180 beats per minute * known major congenital anomaly

Keywords: caffeine citrate