Kornimate/medical-research-clean huggingface dataset:
effect of daily calorie or alternate-day calorie reductions on risk for cardiovascular disease and cancer

Conditions: Moderately Overweight Individuals

Summary: the purpose of this study is to examine and compare the effects of alternate-day reductions in calorie intake or daily calorie restriction on the risk for cardiovascular disease and cancer.

overweight individuals are at greater risk for certain chronic diseases such as cardiovascular disease and cancer when compared to those who are normal weight. dietary restriction has been shown to lower the risk of these chronic diseases in overweight human subjects as well as in normal weight rodents. the majority of studies examining dietary restriction protocols in rodents or humans implement daily calorie restriction (cr), i.e. where the amount of energy consumed is decreased by a certain percentage every day. another dietary restriction regimen employed, although less commonly, is intermittent caloric restriction, or alternate-day fasting (adf), i.e. where food is available ad-librium every other day, alternating with a partial or complete caloric restriction day. recent findings suggest that adf may modulate certain indices of disease risk to a similar extent as daily cr in animal models. the effect of adf regimens in comparison with cr regimens on disease risk has yet to be performed in human subjects, however. adf protocols need not result in weight loss, and would therefore be appropriate for non-obese individuals. accumulating evidence suggest that adipose tissue may play a role in modulating chronic disease risk by releasing substrates, such as fatty acids, or a variety of hormones, including adiponectin and leptin. the effect of adf and cr on adipose tissue metabolism and hormone release remains unclear. accordingly, the aim of the present study is to compare adf regimes to cr for their effects on risk factors for cardiovascular disease and cancer and their effects on adipose tissue metabolism and hormone secretion, in normal weight to modestly overweight (bmi 22-27 kg/m2) human subjects.

Eligibility criteria:
inclusion criteria: * male and female; body mass index (bmi) between 20-30 kg/m2; * age between 35-65 years; sedentary (light exercise less than 1h per week) or moderately active (1 to 2h per week); * weight stable for \>3 months prior to the beginning of the study; * able to give written informed consent; * female subjects must be post-menopausal for at least 2 years and can not be on hormone replacement therapy (hrt). exclusion criteria: * diabetic; * history of cardiovascular disease, i.e. myocardial infarction or stroke; * history of cancer; * taking glucose lowering medication; * taking weight loss medication

Keywords: calorie restriction alternate day fasting calorie intake
peer navigator education in improving survivorship care in african american breast cancer survivors

Conditions: Breast Cancer

Summary: this randomized clinical trial studies peer navigator education in improving survivorship care in african american breast cancer survivors. an educational intervention involving peer groups may help to improve the well-being and quality of life (qol) in breast cancer survivors

primary objectives: i. to evaluate the ability of peer navigation (pn) to improve understanding of survivorship care planning (scp) at 6 months. ii. to promote adherence to the scp schedule of follow-up examinations at 12 months. secondary objectives: i. to evaluate the effect of pn on change from baseline in medical efficacy, preparedness for life as new survivor, and physical and health related qol at 6 months. outline: pns are trained on medical issues and resources, and scp. participants are then randomized to 1 of 2 treatment arms. arm i: participants receive 4 pn sessions tailored to their needs followed by a 6 month booster session and american cancer society (acs) materials. arm ii: participants receive acs materials. after completion of study treatment, patients are followed up at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * trial subjects: * patient age 18 years or older who self-identifies as african-american * in early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer * receiving health care primarily through an health maintenance organization (hmo) * patients with metastatic cancer or a second primary cancer, because their medical characteristics (e.g. disease progression) are significantly different * breast cancer survivors (bcs) with other major disabling medical, psychiatric, or substance abuse conditions (e.g., anxiety, depression, alcohol/tobacco problems) will be excluded * peer navigators: * at least 25 years of age who self-identifies as african-american * previously participated in any type of research study * has at least high school education * has been diagnosed with breast cancer, currently in remission or eradicated * belongs to a breast cancer support group * has a valid driver's license * owns an operational vehicle * has access to a personal computer with internet access

Keywords: cancer survivor
sjg-136 in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: this phase i trial is studying the side effects and best dose of sjg-136 in treating patients with advanced solid tumors. drugs used in chemotherapy, such as sjg-136, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

primary objectives: i. to determine the toxicities, pharmacokinetic profile and the recommended phase 2 dose of sjg-136 in patients with an advanced solid tumor. secondary objectives: i. to determine preliminary efficacy data and evaluation of correlative markers of dna damage and apoptosis in peripheral blood lymphocytes. outline: this is an open-label, dose-escalation study. patients receive sjg-136 intravenously (iv) over 20 minutes on days 1, 8, and 15. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of sjg-136 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. at least 6 patients are treated at the mtd.

Eligibility criteria:
inclusion criteria: * histologically confirmed solid tumor * advanced disease, defined as metastatic or unresectable disease * measurable indicator lesions * standard curative or palliative measures do not exist or are no longer effective * previously treated cns metastases allowed provided patient has completed local therapy and corticosteroids have been discontinued for at least 4 weeks * no known leptomeningeal metastases * performance status - ecog 0-2 * performance status - karnofsky 60-100% * more than 3 months * wbc ≥ 3,000/mm\^3 * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * bilirubin ≤ 1.0 mg/dl * ast and alt ≤ 2.5 times upper limit of normal * creatinine \< 1.4 mg/dl * no congestive heart failure * no recent myocardial infarction * no unstable angina * no uncontrolled hypertension * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no active infection * no history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug * no other significant medical history, unstable medical condition, or unstable systemic disease that would preclude study participation * at least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas and 8 weeks for ucn-01) * at least 4 weeks since prior radiotherapy * no prior radiotherapy to ≥ 25% of hematopoietic bone marrow * recovered from all prior therapy * at least 4 weeks since prior investigational anticancer drugs * no other concurrent investigational agents * no concurrent combination antiretroviral therapy for hiv-positive patients
utility and procedural feasibility of reboa operationalized for non-trauma application (up-front)

Conditions: Cardiac Arrest, Out-Of-Hospital; Ventricular Fibrillation; Ventricular Tachycardia

Summary: single center randomized-controlled trial in out-of-hospital cardiac arrest (ohca) patients. this study will investigate the feasibility and utility of the resuscitative endovascular balloon occlusion of the aorta (reboa) procedure using a reboa catheter device in patients who have experienced an ohca and have not regained return of spontaneous circulation (rosc).

victims arriving to, or experiencing witnessed ventricular fibrillation (vf) or ventricular tachycardia (vt) out of hospital cardiac arrest in, the uab emergency department with greater than 10 minutes of conventional acls will be eligible. the study population will consist of forty (40) subjects randomized to either continued contemporary standard of care (acls), or acls plus the administration of a reboa catheter device. the aims of upfront are: 1. to describe the feasibility of rapid deployment of a reboa catheter device in the setting of ohca 2. to evaluate the utility of a reboa catheter device to achieve rosc in the setting of ohca.

Eligibility criteria:
inclusion criteria: 1. apparent age between 18 - 70 years. 2. ohca defined as receiving professional cpr or aed defibrillation 3. ohca witnessed by bystanders or professional rescuers / ued personnel 4. vt/vf as the presenting rhythm for ohca or clearly documented vt/vf during ohca 5. total time pulseless \> 10 minutes exclusion criteria: 1. obvious pre-existing neurocognitive impairment precluding independent activities of daily living 2. obvious or suspicion of anatomic abnormality preventing successful deployment of reboa device (i.e. previous vascular surgery in access region, dialysis graft, etc.) 3. clear non-cardiac etiology (traumatic, hanging, overdose, etc.) of cardiac arrest 4. do-not-resuscitate order or comfort care measures in place prior to enrollment 5. special populations (pregnant, prisoner, or cognitively impaired) 6. total time pulseless greater than 20 minutes 7. inability to determine when cardiac arrest occurred (or for ohca arriving to ued via ems, time of 911 call) and the time elapsed since

Keywords: cardiac arrest out of hospital cardiac arrest reboa
anterior pelvic prolapse reconstruction with tiloop® pro a polypropylene mesh

Conditions: Cystocele; Uterine Prolapse

Summary: the purpose of this study is to determine the influence of anterior pelvic prolapse reconstruction with a titanized polypropylene mesh on patients quality of life.

this multicentre, non-randomized, observational clinical investigation will be performed to obtain usability and postmarket information on the tiloop® pelvic floor reconstruction meshes and in particular to obtain the improvement of patients' quality of life. it is expected that the patient's quality of life is meliorated after implantation of a tiloop® pro a mesh. to verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 12 months is significantly better than before implantation.

Eligibility criteria:
inclusion criteria: 1. existence of a cystocele. women with a symptomatic genital descensus: at least stage ii (ics-classification according pop-q system). this applies to primary as well as recurrent intervention. 2. patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation. 3. patient information has been handed out and written consent is at hand. 4. patient has attained full age (18 years or older). exclusion criteria: 1. unfinished family planning, pregnancy or breast-feeding mother. 2. known intolerance to the mesh-implants under investigation. 3. lack of written patients' informed consent. 4. lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol. 5. patients with acute (within the last 12 months) carcinoma in the pelvic area. 6. patients with history of radiotherapy in the pelvic area. 7. patients with implanted anterior pelvic floor mesh. 8. patient is institutionalized by court or official order (mpg §20.3). 9. participation in another interventional clinical investigation.

Keywords: polypropylene mesh prolapse cystocele surgical mesh
effect of inhaled fentanyl on dyspnea and exercise tolerance in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: breathing discomfort (dyspnea) and activity limitation are dominant symptoms of chronic obstructive pulmonary disease (copd) and contribute to poor health-related quality of life in this population. several small, uncontrolled studies and published case reports have provided evidence that inhaled fentanyl, a powerful pain relieving (opioid) medication, may be used to effectively reduce breathing discomfort in patients with advanced disease. however, the mechanisms of this improvement remain unclear. therefore, the investigators plan to conduct the first randomized, double-blind, placebo-controlled, crossover study designed to explore the possible mechanisms of action of inhaled fentanyl on activity-related dyspnea and exercise performance in patients with advanced copd.


Eligibility criteria:
inclusion criteria: * post-bronchodilator forced expiratory volume in 1 sec (fev1) 30-79% predicted, fev1/forced vital capacity (fvc) ratio \<70%; * clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding 6 weeks; * a cigarette smoking history ≥20 pack-years; * significant chronic activity-related dyspnea as defined by a baseline dyspnea index focal score ≤ 6; * body mass index (bmi) between 18.5 and 30.0 kg/m2; * able to perform all study procedures and provide/sign informed consent. exclusion criteria: * a diffusing capacity of the lung for carbon monoxide (dlco) \<40 %predicted; * presence of active cardiopulmonary disease other than copd that could contribute to dyspnea and exercise limitation; * clinical diagnosis of sleep disordered breathing; * a history/clinical evidence of asthma, atopy and/or nasal polyps; * history of allergy or adverse reaction to fentanyl; * presence of important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s); * use of daytime oxygen or exercise-induced arterial oxygen desaturation to \<80% on room air; * use of antidepressant drugs (i.e., monoamine oxidase inhibitors, serotonin reuptake inhibitors) in previous 2 weeks; * use of opioid or pain relieving drugs (e.g., morphine, fentanyl, oxycodone, hydromorphone, methadone, levorphanol, codeine, hydrocodone, meperidine) in previous 4 weeks.

Keywords: inhaled fentanyl dyspnea exercise copd
arrhythmia prevention with an alpha-linolenic enriched diet

Conditions: Atrial Fibrillation; Diet Therapy

Summary: an alpha linolenic acid (ala) rich diet in the lyon diet heart study reduced sudden cardiac deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation (lancet 1994). since then, there has been a growing interest in ala, ω-3 fatty acid family precursor, as a cardioprotective nutrient. much of the interest has focused on the potential antiarrhythmic effect of longer chain ω-3 fatty acids, dha and epa, derived from fish. we therefore concluded it important to test wether vegetable source ω-3 also had antiarrhythmic effects, as shown in animals by leaf and mclennan, since this might also explain the beneficial effects seen on cardiovascular mortality in the lyon diet heart study.

objective: to determine the effect of an ala rich diet in reducing recurrence of atrial fibrillation as a further example of a cardiac arrhythmia. design: randomized parallel design efficacy study. setting: three university hospital centers in the bordeaux region, france. patients: 98 patients randomized immediately after successful atrial fibrillation electrical cardioversion. intervention: a canola margarine and oil, versus a conventional diet (control), with a one year follow-up. main outcome measure: length of time to first recurrence of atrial fibrillation. significance: if ala is antiarrhythmic, this action may explain its cardioprotective effect in clinical trials and cohort studies.

Eligibility criteria:
inclusion criteria: * patients hospitalized in one of the three centers in the bordeaux region * clinical diagnosis of atrial fibrillation * who subsequently underwent successful electrical cardioversion exclusion criteria: * unable to receive electrical cardioversion * already enrolled in another trial * unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements * clinically significant cardiac disease, advanced heart failure, cardiac cachexia * thyroid disease, treated or untreated, * clinically significant hepatic or renal disease * history of malignant disease * alcohol abuse * taking ala rich foods or recording intakes of ala \>2g/d on the control diet or reporting using \<1g/d on the ala diet was considered a major deviation from the protocol

Keywords: alpha linolenic acid atrial fibrillation omega 3 fatty acids diet rapeseed oil canola oil cardiovascular diseases
optical frequency domain imaging (ofdi) for biliary stricture imaging

Conditions: Biliary Stricture

Summary: the goal of this study is to evaluate the potential of comprehensive biliary optical frequency domain imaging (ofdi) for assessing common bile duct or common hepatic duct strictures, determining cholangiocarcinoma margins, and evaluating primary sclerosing cholangitis (psc).

the study will be conducted in approximately 20 patients with known or suspected common bile duct or common hepatic duct stricture scheduled for endoscopic retrograde cholangiopancreatography (ercp) with duodenoscope-assisted cholangiopancreatoscopy (dacp) and biopsy. following initial fluoroscopic evaluation, the study experimental procedure will begin. the catheter will be passed through the auxiliary channel of the duodenoscope, across the papilla and into the common bile duct. the extra-biliary portion of the catheter will be visible by the duodenoscope at all times. the intrabiliary portion of the catheter will be visible by fluoroscopy, and will be positioned across the biliary stricture. rotational cross-sectional images of the bile duct will be obtained using the ofdi imaging catheter while pulling back the internal optical components over a pre-determined length. ofdi imaging will be conducted approximately from 1 cm distal to 1 cm and proximal to the stricture margins identified by fluoroscopy.

Eligibility criteria:
inclusion criteria: * patient age ≥18 and up to 75 years old * patients able to give informed consent * patients with bile duct measuring ≥4 mm in diameter * patients with established biliary enteric access - specifically, a previously performed biliary sphincterotomy, or a biliary sphincterotomy performed during the current ercp for indications other than participation in the study * women of childbearing potential must have a negative urine pregnancy test obtained prior to the procedure exclusion criteria: * patients with pancreatitis * pregnant women * patients on oral anticoagulant (warfarin) therapy * patients with known history of hemostatic disorder * patients found to have a biliary fistula on diagnostic ercp

Keywords: biliary stricture oct imaging
efficacy and safety of short duration of dapt after genoss® des implantation in patients with coronary artery disease

Conditions: Percutaneous Coronary Intervention; Dual Antiplatelet Therapy

Summary: the objective of study is to evaluate the efficacy and safety of short duration of dapt after genoss® des implantation in patients with coronary artery disease.

the genoss des is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of short duration of dapt after genoss® des implantation in patients with coronary artery disease. the genoss des registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of short duration of dapt (3 months for scad, 6 months for acs) after genoss des implantation in patients with coronary artery disease from 6 sites in south korea. the primary endpoint was a device-oriented composite endpoint (doce), defined as a composite of cardiac death, target vessel-related myocardial infarction (mi), and clinically indicated target lesion revascularization (tlr) at 12 months. the key secondary endpoint was a patient-oriented composite endpoint (poce), defined as a composite of all-cause death, any myocardial infarction, and any revascularization at 12 months.

Eligibility criteria:
inclusion criteria: 1. patients of 19 and over 2. patients with coronary artery disease treated with genoss ses 3. participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants exclusion criteria: 1. patients with cardiogenic shock at the time of hospitalization 2. patients who are pregnant or planning to become pregnant 3. patients with a life expectancy of less than 1 year 4. patients participating in randomized controlled trials using other medical devices 5. patients who have already received treatment with another des (drug eluting stent) or bms (bare metal stent) at the time of registration (however, other stent insertions are allowed due to failure of genoss des insertion)
correlation of blood serum renalase and microcirculation obstruction in patients with acute myocardial infarction after primary percutaneous coronary intervention

Conditions: Acute Myocardial Infarction

Summary: this research will explore the association between blood serum renalase and microcirculation obstruction in patients with acute myocardial infarction (ami) after primary percutaneous coronary intervention (pci). the investigators aim to identify potential risk factors for microcirculation obstruction in ami patients after ppci.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. stemi symptom onset time \< 12 hours; 3. stemi symptom onset time 12-48 hours with persistent ischemic symptoms, hemodynamic instability, or life-threatening ventricular arrhythmias; 4. high-risk nstemi; 5. emergency pci; 6. voluntary informed consent. exclusion criteria: 1. non-obstructive acute myocardial infarction; 2. severe chronic kidney disease (defined as estimated glomerular filtration rate \< 20 ml/min per 1.73 m²); 3. life expectancy \< 1 year; 4. pregnant or planning to become pregnant; 5. emergency pci failure.