Kornimate/medical-research-clean huggingface dataset:
prevention and comparison of different forms of administration of nitrates in the risk of radial spasm during coronary angiography.

Conditions: Coronaropathy

Summary: the radial approach for a coronary angiography is currently adopted by several centers because of its simplicity. the radial artery spasm is the main inconvenient. nitrates in intra-arterial have been widely studied in prevention of this spasm. no studies have compared the different routes of administration of nitrates as a patch and a continuous intravenous injection.

the radial approach is favored for coronary angiography due of several advantages: reduction of local bleeding risk, even in the most hemorragiparic situations, decreased downtime and time reduction of hospitalization, improved patient ulterior comfort. however, this approach is subject to an immediate major complication that is the radial artery spasm (ras) which, according to the criteria used, has an average incidence of 30%. the administration of a vasodilator just before coronary angiography procedure enables an increase of the radial artery diameter and thus a decrease of friction probes. theoretically this prevents the occurrence of the ras. the literature re-counts several vasodilator product tests (dn calcic blocker, magnesium sulfate, alpha-adrenergic antagonist ...) and various routes of administration (direct intravenous route (iv), subcutaneous injected route, direct intra-arterial route (ia)). overall intra-arterial dn appears to be more efficient. the downside is a brief, painful thermal sensation but intense and notably unpleasant. iv injection is better tolerated but it was a direct injection and without proof of its superiority over ia. the para-radial subcutaneous injection has only been studied to facilitate access to the radial artery. the investigators randomized study compares, for the first time, the effectiveness of the transdermal administration of trinitrine (d) and continuous intravenous of dinitrate isosorbide (v) to dinitrate isosorbide intraarterial (a) standard.

Eligibility criteria:
inclusion criteria: * patients \> 18 ans. * patients with hemodynamic stability. * patients informed consent was signed by each individual. the study obtained approval from the local ethics committee. exclusion criteria: * 'test d'allen' negative * pregnancy. * stemi * hemodynamic instability : pas \ 100 bpm, tachycardia uncontrollable. * allergy of nitrates.
reducing health problems associated with injection drug use

Conditions: Intravenous Drug Abuse; HIV Infections

Summary: the purpose of this study is to develop and test an intervention to reduce bacterial and viral infections among injection drug users.

injection drug use (idu) is a major public health problem that is associated with a host of medical complications, including blood-borne viral disease (e.g., hiv, hepatitis c) and bacterial infections (e.g., skin abscesses, endocarditis), that often result from high-risk drug injection practices. there are no current interventions designed to reduce bacterial infections among idus, despite high rates of infection. the objective of this study is to develop and test the efficacy of a skin and needle hygiene intervention for idus to reduce practices associated with bacterial and viral infections. in the first phase of the study, focus group interviews were conducted to determine key areas of emphasis for an intervention with this population. an initial intervention was developed, pilot tested, and refined. the final 2-session intervention combines psychoeducation, skill-building, and motivational interviewing. following refinement of the intervention, a small randomized controlled trial (n = 60; 30 in each group) to examine the efficacy of the intervention compared to an assessment-only condition will be conducted. the goals of this two-year study are to: 1) reduce high-risk injection practices among active idus that lead to bacterial and viral infections, 2) improve skin and needle cleaning behavioral skills, and 3) increase skin cleaning prior to injection and reduce subcutaneous/intramuscular injection. in addition to examining these goals over a six-month period, the acceptability and feasibility of the intervention will be examined.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * injection of heroin on at least three different days in the last week * injection of heroin for at least three months * visible track marks/puncture wounds from needles * positive urine screen for heroin exclusion criteria: * currently exhibiting active psychotic symptoms * cannot complete study assessments or the intervention * cannot provide informed consent * unable to provide names and contact information for at least two verifiable locator persons who will know where to find client * plans to relocate from area or be jail over next six months * have been in a project safe study in the last year * report being pregnant or attempting to become pregnant

Keywords: bacterial infections skin infections hiv hepatitis c risk reduction intervention
randomized trial of segmental versus circumferential antral ablation in paroxysmal atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation

Summary: an isolation-limited segmental antral approach to pulmonary vein isolation is as effective in achieving long-term freedom from atrial fibrillation as the standard anatomic, circumferential antral ablation.

this is a randomized controlled non-inferiority designed trial. follow up: patients will stop their anti-arrhythmic drugs 2 months post procedure. follow-ups will involve clinical assessment, holter and/or loop recorders at 3, 6, 9, and 12 month intervals.

Eligibility criteria:
inclusion criteria: * paroxysmal atrial fibrillation (paf) for at least 6 months with at least 1 symptomatic episode during the previous 6 moths * patient must be felt to be candidates for atrial fibrillation (af) ablation based on af that is symptomatic and refractory or intolerant to at least one class 1 or 3 anti-arrhythmic agent * documentation of at least one episode of af on 12 lead ecg, ttm or holter monitor within 12 months of randomization in the trial * patient must be on continuous anti-coagulation with warfarin (inr 2-3) or fractionated subcutaneous heparin for \>4 weeks prior to the ablation or they have undergone a recent (less than 48 hours before planned ablation) transoesphageal echocardiogram to exclude left atrial thrombus. * patient must provide written informed consent to participate in the clinical trial exclusion criteria: * contraindications to oral anticoagulants * history of any previous ablation for af * intracardiac thrombus * af due to reversible causes * pregnancy * atriotomy scar (typically, mv or tv repair/replacement, asd surgery, transplants)(cabg are okay)
sga for tee: safe alternative to deep sedation for patients with high-risk cardiopulmonary disease.

Conditions: Cardiopulmonary Disease

Summary: increasingly, transesophageal echos (tees) are being done on high risk patients. a tee is a short procedure done with deep sedation, but poses an increased risk of apnea/ hypoxemia in those with pulmonary disease. it is desirable to avoid intubation, which adds risk. use of supraglottic airway (sga) may offer an alternative. the investigators hypothesize that tees can be done successfully with an sga in place. the investigators propose a prospective rct to compare tee exams done with deep sedation to those done with an sga.

increasingly, non-operating room anesthesia (nora) cases are being performed on patients with high risk for needing advanced airway management, ie patients with morbid obesity, chronic hypoxemic lung disease, obstructive sleep apnea. transesophageal echocardiography (tee) exams are one example of this. while a tee is typically a short, diagnostic procedure done with deep sedation, deep sedation poses an increased risk of hypoventilation and hypoxemia in patients with cardiopulmonary disease. it is desirable to avoid endotracheal intubation for tee exams, as the procedure is short and can easily be done without muscle relaxation. moreover, securing the airway with an endotracheal tube (ett) is not without significant risk. the use of a supraglottic airway (sga) may offer an alternative for patients receiving a tee who are high risk candidates for deep sedation with a natural airway. the investigators hypothesize that the tee procedure can be done successfully, without interruption, with an sga in place. our secondary hypothesis is that sga use in high-risk patients may be safer than deep sedation, as there may be less episodes of hypoventilation and hypoxemia. the investigators propose a prospective randomized control trial to compare tee exams done with deep sedation (control group) to those done with sga (intervention group). our primary outcome will be tee study completion, and secondary outcomes will focus on the safety profile of the two groups.

Eligibility criteria:
inclusion criteria: * adults presenting for elective outpatient tee examinations at uf shands hospital during the study duration exclusion criteria: * known or suspected difficult airway, patient refusal or inability to consent, patients to have emergent or urgent tee exams, patients considered to have full stomach ie gastroparesis or achalasia

Keywords: tee sga anesthesia sedation chronic hypoxemic lung disease obstructive sleep apnea morbid obesity
cannabinoid modulation of pain

Conditions: Pain

Summary: the purpose of this study is to test the effects of cannabinoids on pain response using a variety of human experimental pain models.


Eligibility criteria:
inclusion criteria: * at least one lifetime exposure to cannabis * acceptable birth control methods for females exclusion criteria: * cannabis naive * medical or psychiatric contraindications * analgesic medication * previous sensitivity to thc or cannabis

Keywords: cannabis thc pain
prevention of pegfilgrastim-induced bone pain (pibp)

Conditions: Musculoskeletal Complications; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: naproxen may help prevent or lessen bone pain caused by pegfilgrastim. it is not yet known whether naproxen is more effective than a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy. purpose: this randomized phase iii trial is studying naproxen to see how well it works compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.

objectives: primary * to compare the efficacy of daily administration of naproxen vs placebo in preventing or reducing the severity and duration of pegfilgrastim-induced bone pain (pibp) in patients with non-hematologic malignancies undergoing chemotherapy. secondary * to identify potential risk factors for the development of pibp. * to identify potential clinical predictors for the response or failure to respond to naproxen in preventing pibp. * to assess the toxicity of naproxen when administered in the preventive setting. outline: this is a multicenter study. patients are stratified by clinical community oncology program (ccop) site. patients are randomized to 1 treatment arm vs placebo. * arm i: patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days. * arm ii: patients receive matching placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

Eligibility criteria:
inclusion criteria: * diagnosis of a non-hematologic (non-myeloid) malignancy * scheduled to receive chemotherapy; chemotherapy may be given for adjuvant, neoadjuvant, curative, or palliative intent * scheduled to receive the first dose of pegfilgrastim (neulasta®) to ameliorate chemotherapy-induced neutropenia * creatinine ≤ 1.5 times upper limit of normal * able to understand english * more than 6 months since prior surgery on the heart exclusion criteria: * pregnant or nursing * clinical evidence of active gastrointestinal bleeding, prior gastrointestinal bleeding, or gastric or duodenal ulcers * allergy to naproxen * prior development of the triad of asthma, rhinitis, and nasal polyps after taking acetylsalicylic acid (aspirin) or other nsaids * concurrent nonsteroidal anti-inflammatory drugs (nsaids), such as aspirin, ibuprofen, or any product containing naproxen (e.g., naprosyn, ec-naprosyn, anaprox, anaprox-ds, naprosyn suspension, or aleve), on a regular basis * concurrent steroids on a regular basis * concurrent prescription or non-prescription medications for preexisting chronic pain; concurrent cardioprotective doses (≤ 325 mg/day) of aspirin allowed * concurrent therapeutic doses of warfarin

Keywords: pain musculoskeletal complications unspecified adult solid tumor, protocol specific
intermittent versus continuous surface o2 during hmp of dcd kidneys

Conditions: Delayed Graft Function; Kidney Transplant; Complications; Ischemia Reperfusion Injury; Mitochondrial

Summary: the aim of the study is to evaluate the feasibility of this bubble and surface oxygenation and to determine the optimal timing of surface oxygenation (continuous versus intermittent) as alternative for membrane-oxygenated kidneys, originating from dcd donors, during hmp on early graft function in clinical practice.

kidneys originating from deceased donors after circulatory death (dcd), category 3 and 5 (controlled) will be preserved from procurement until transplantation on hypothermic machine perfusion conditions and prospectively randomized into 2 study groups: 1) intermittent surface oxygenation during hmp (surface oxygenation interrupted during organ transport (2-4h)(i-hmpo2 group), and 2) continuous surface oxygenation during hmp (surface oxygenation during the whole machine preservation period included organ transport)(c-hmpo2 group).

Eligibility criteria:
inclusion criteria: * listed for a renal transplantation due to end stage renal disease * willingness to comply with the protocol procedures for the duration of the study included scheduled follow-up visits and examinations. exclusion criteria: * multi-organ recipients * dual kidney transplantation

Keywords: hypothermic oxygenated machine perfusion kidney preservation bubble and surface oxygenation
meditation awareness training for the treatment of fibromyalgia syndrome

Conditions: Fibromyalgia Syndrome

Summary: a randomised controlled trial to evaluate the effectiveness of a second-generation mindfulness-based intervention known as meditation awareness training (mat) for treating fibromyalgia syndrome.

background: fibromyalgia syndrome (fms) is a chronic pain disorder that frequently leads to poor quality of life. the need for more effective fms treatments has prompted empirical investigations into the applications of mindfulness for treating the condition. however, studies have predominantly focused on first-generation mindfulness-based interventions (fg-mbis). to date, a randomised controlled trial (rct) assessing the effectiveness of a second-generation mindfulness-based intervention (sg-mbi) for treating fms has not been undertaken. sg-mbis are distinct from fg-mbis because they are overtly spiritual in nature and employ (i) a greater range of (normally secularised) meditative/spiritual techniques, (ii) ethics as a key component of the taught programme, and (iii) an instructor training programme that typically requires several years of supervised mindfulness practice. aims: to evaluate the effectiveness of meditation awareness training (mat) - an sg-mbi - for treating fms. method: adults with fms will receive mat or an active control intervention known as cognitive-behavioural therapy for groups. assessments will be performed at pre-intervention, post-intervention, and follow-up phases.

Eligibility criteria:
inclusion criteria: * current diagnosis of fibromyalgia syndrome * aged between 18 and 65 years * able to read and write using the english language * available to complete an eight-week intervention and six-month follow-up assessment exclusion criteria: * currently undergoing formal psychotherapy * changes in psychopharmacology type or dosage one-month prior to intervention * currently practicing mindfulness or meditation

Keywords: fibromyalgia syndromey
clinical characteristics, management and outcomes of chinese patients with acute aortic dissection

Conditions: Aortic Dissection

Summary: data reported by the international registry of acute aortic dissection (irad) in not sufficient to reflect clinical characteristics of acute aortic dissection in china. moreover, clinical characteristics of acute aortic dissection have not evaluated to data. the aim of this study is analyze changing trend of clinical characteristics of chinese patients with acute aortic dissection.

acute aortic dissection is the most common aortic emergency, with an annual incidence of 3-5 cases per 100 000 population. about 50% of these patients are dead within 48 hours, if untreated. to assess the clinical manifestation, diagnosis, management, and outcomes of patients with aad, the international registry of acute aortic dissection (irad) was established in 1996, and has grown to include about 2000 patients from 26 large referral centers to date. all patients from irad are caucasians from developed countries wiht advanced medical care, however, the proportion of asian is very low. data reported by the irad in not sufficient to reflect clinical characteristics of acute aortic dissection in china. clinical characteristics of chinese patients with acute aortic dissection have not evaluated to data. the aim of this study is to analyze clinical characteristics of chinese patients with acute aortic dissection and clinical trend of acute aortic dissection.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute aortic dissection * type a dissection * type b dissection * retrograde type b dissection exclusion criteria: * aortic aneurysm * myocardial infarction * cerebral accident * active infection * unwillingness to cooperation with study procedures or follow-up visits

Keywords: aorta dissection feature
non-expensive and widely available tests as diagnostic tools in dementia and their ability to predict disease progression

Conditions: Alzheimers Disease; Mild Cognitive Impairment

Summary: alzheimers disease (ad) is the most common course of cognitive decline and thereby the course of more than half of all cases of dementia. a proper ad diagnosis is rested on a number of examinations and tests, which combined can make ad diagnosis likely. but no single test or examination can unambiguous determine whether the patient has ad or not. comparatively no examination or test can with accuracy predict whether a healthy person or a person with only mild cognitive (mci)impairment in time will evolve ad. quantitative electroencephalography (qeeg), cerebrospinal fluid (csf) biomarkers, linear ct analyses and timed up and go - dual task (tug-dt) are relatively inexpensive and and widely available diagnostic methods, which have the potential to diagnose ad at an early stage in a reliable accurate way. but they also have the potential to predict which patients diagnosed with mci have particular risk of developing dementia. the purpose of the study is to investigate the relations between qeeg, csf biomarkers, ct analyses and tug-dt outcome and clinical features in healthy persons as well as patients with mci and ad furthermore to investigate whether qeeg or csf biomarkers can predict which patients with mci will in time evolve ad.


Eligibility criteria:
inclusion criteria: for patients: * age 50 to 90 * diagnosed with mci or ad * cerebrospinal fluid examination and eeg performed at baseline for control persons: * age 50 to 90 * mmse score equal or above 26 * ace score equal or above 85 * normal physical examination, including normal blood samples, ct of cerebrum and eeg examination exclusion criteria: * pregnant or breastfeeding * psychiatric disease, former depression is allowed if antidepressive treatment has been initiated of a leat 3 months duration * neurologic or somatic disease, including former severe head trauma or neuroinfection * antipsychotic treatment * former severe abuse of alcohol, medication or drugs * ect treatment or anaesthesia within the last 3 months * no closely related person to assist the patient additionally exclusion criteria for healthy control persons: * meet the diagnostic criteria for mci or ad
study of s-1 plus dc-cik for patients with unresectable locally advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the antitumor effect and safety of clinical effectiveness s-1 plus dendritic cell activated cytokine induced killer treatment (dc-cik) for unresectable locally advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery. * capable of oral intake * between 18 and 80 years old * measurable disease as defined by response evaluation criteria in solid tumors (recist) criteria * karnofsky performance status (kps) ≥ 70% * normal functions of heart, lung and bone marrow * adequate hematological profile： hemoglobin ≥ 9.0 g/dl absolute granulocyte count ≥ 1,500/mm3 platelet count ≥ 100,000/mm3 * adequate hepatic function total bilirubin level≤ 3.0 times the upper limit of normal (uln) transaminases ast (sgot) and alt (sgpt) ≤ 2.5 times uln * adequate renal function(normal serum creatinine level) * a life expectancy≥ 2 months * informed consent signed exclusion criteria: * current enrollment in another clinical study with an investigational agent. patients participating in surveys or observational studies are eligible to participate in this study * any radiotherapy or surgery within the previous 3 weeks * symptomatic brain metastasis not controlled by corticosteroids * bone marrow metastasis * active infection * serious complications * receiving a concomitant treatment with drugs interacting with s-1. the following drugs are prohibited because there may be an interaction with s-1: phenytoin, potassium warfarin , flucytosine, cimetidine and folinic acid. * pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy

Keywords: pancreatic cancer s1 dc-cik
a new drug for benign prostatic hyperplasia (bph) compared with placebo

Conditions: Benign Prostatic Hyperplasia

Summary: a new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. the study lasts approximately 20 weeks.

this will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the internation prostate symptom score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Eligibility criteria:
inclusion criteria: * males in good general health and at least 50 years of age, with symptoms of moderate to severe bph. exclusion criteria: * medical conditions that would confound the efficacy evaluation. * medical conditions in which it would be unsafe to use an alpha-blocker. * the use of concomitant drugs that would confound the efficacy evaluation. * the use of concomitant drugs that would be unsafe with this alpha-blocker.

Keywords: benign prostatic hyperplasia, alpha blocker