Kornimate/medical-research-clean huggingface dataset:
coronary hybrid revascularisation study

Conditions: Significant Coronary Artery Disease

Summary: the purpose of the registry is to assess results of combined operative and catheter based (hybrid procedure) treatment of patients with significant coronary artery disease using essential clinical and angiographic parameters. based on existing literature we expect the results of coronary artery bypass grafting of the anterior descendent coronary artery (lad), segment 1 and 2, using the so-called mammary artery graft, to be superior to stent treatment of the same artery. at the same time a catheter based intervention using balloon, bare metal stents (bms) or drug eluting stents (des) seems to be a better treatment that a saphenous vein graft for other coronary arteries than the lad. i.e. the right coronary artery (rca) and the left circumflex coronary artery (cx). therefore, we expect a combination of the mentioned surgical and catheter based techniques to be a better treatment than bypass operation or catheter based intervention alone.

a total of 150 consecutive patients will be included in the study. the patients will have a coronary artery narrowing located to the lad, which can be treated with a mammary graft, and a stenosis located to other coronary arteries (rca and cx), which can be treated by balloon or stent. the patients included in the study will be recruited from patients who are referred to the department of cardiology/department of thoracic surgery, aarhus university hospital, skejby for treatment of significant coronary artery disease. we will not announce for patients, and the patients will not receive a honorarium for participation. the first 100 patients will be treated i two seances; operation and stent treatment with few days interval. the last 50 patients will be treated in a hybrid operation room with operation and stent treatment in the same seance.

Eligibility criteria:
inclusion criteria: * stable, unstable angina pectoris and acs. * significant stenosis of lad, segment 1 or 2 and of other coronary arteries. * the patient can be treated with a mammary graft to lad and by balloon or stent of other lesions. * signed informed consent must be available. exclusion criteria: * earlier cardiac surgery * treatment with coronary stent within one year. * st-elevation infarction within 24 hours. * coronary artery lesions located to lad, segment 1 or 2, which cannot be treated by coronary bypass operation. * stenosis of diagonal branches, cx artery and the right coronary artery, which cannot be treated by pci. * expected survival \<1 year following successful treatment. * allergy to aspirin, clopidogrel, ticlopidine and/or prasugrel. * allergy to sirolimus, everolimus, zotarolimus og biolimus for the patients treated with coronary hybrid intervention in the same seance further exclusion criteria: known disorder of the bloods ability to coagulate (such as renal failure (dialysis or renal creatinine clearance \< 50ml/min), congenital coagulopathy, needs for anticoagulant treatment before surgery) previous gastrointestinal bleeding or previous cerebral
bendamustine hydrochloride injection for initial treatment of chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: to compare the clinical efficacy and safety of bendamustine hydrochloride versus chlorambucil for initial treatment of chronic lymphocytic leukemia

patients will be assessed for response after three cycles of treatment. two additional cycles are recommended for cr, pr or sd patients, up to a maximum limit of six cycles in total. patients will be followed up every three months until disease progression or death.

Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of cll according to national cancer institute (nci) working group criteria * no prior treatment for cll * binet stage b or c * ecog performance status ≤ 2 * life expectancy ≥3 months * ast and alt ≤ 3 x uln; total bilirubin ≤ 2 x uln; creatinine clearance ≥ 40 ml/min * written informed consent exclusion criteria: * patients were diagnosed with or treated for malignant tumors other than cll (including central nervous system lymphoma) within one year prior to entering the study * transformation to richter's syndrome, or prolymphocytic leukemia (pll) * autoimmune hemolytic anemia requiring glucocorticoid therapy * autoimmune thrombocytopenia requiring glucocorticoid therapy * participation in any other clinical trials within 4 weeks prior to study entry * any of the following conditions: severe heart failure; cardiomyopathy; myocardial infarction within 6 months; severe, uncontrolled diabetes; severe, uncontrolled hypertension; active, uncontrolled infection; central nervous system dysfunction * patients received major surgery within 30 days prior to study entry * pregnant or lactating women * allergic to study drug or mannitol

Keywords: chronic lymphocytic leukemia bendamustine hydrochloride chlorambucil
study of nicotinamide in early onset preeclampsia

Conditions: Pre-Eclampsia; Pregnancy Related

Summary: phase ii study of 2.5 gm of nicotinamide, given daily in 3 divided doses, to measure effect on maternal blood pressure in women with early onset preeclampsia and to determine peak and trough levels of nicotinamide. we will compare peak and trough levels in healthy non-pregnant and healthy pregnant participants.

see brief summary above

Eligibility criteria:
diagnosis and inclusion criteria * maternal age 18-55 years * singleton pregnancy with no known fetal anomalies * early-onset preeclampsia or early-onset severe gestational hypertension defined as: * early-onset: between 24 weeks 0 days and -33 weeks 3 days, based on menstrual dating confirmed by first or second trimester ultrasound or second trimester ultrasound if menstrual dating unavailable; * preeclampsia: * new onset hypertension and proteinuria, with systolic bp \> 140 mm hg and/or diastolic bp \> 90 mm hg on two occasions 6 hours apart and \> 300 mg proteinuria on 24 hour urine collection or urine p/c ratio \>0.3; * new onset hypertension and no proteinuria, with systolic bp \> 140 mm hg and/or diastolic bp \> 90 mm hg on two occasions 6 hours apart and one or more of the following: serum creatinine \>1.1 mg/dl or doubling from baseline ,or central nervous system symptoms or visual changes * severe preeclampsia defined as new onset systolic bp \> 160 mm hg and/or diastolic bp \> 105 with proteinuria as above or or without proteinuria and one or more of the following criteria listed above * candidate for expectant management for at least 48 hours * deemed clinically stable by primary clinician and candidate for expectant management (delayed delivery) for at least 48 hours; * maternal liver function tests \< 2x uln * maternal platelet count \> 100,000 mm³ * planned expectant management * pre-existing medical diseases such as hypertension, diabetes, endocrine disorders, gastrointestinal diseases, are well controlled * fetal well-being established by estimated fetal weight \> 5th %tile; normal amniotic fluid volume (mvp \> 2 cm); normal umbilical artery (ua) dopplers; or reactive non stress test (nst) or biophysical profile (bpp) \> 6 * delivery not anticipated within 48 hours of enrollment exclusion criteria * pre-existing renal disease (creatinine \> 1.5 mg/dl) * any pre-existing medical condition that would increase risk for liver toxicity (e.g. hepatitis b or c; hiv; isoniazid (inh) use) * eclampsia; cerebral edema on ct/mri; headache unrelieved by analgesics * evidence of liver dysfunction (lfts \> 2x uln) * thrombocytopenia (platelets \< 100,000 mm³) * pulmonary edema * hellp syndrome * evidence of fetal compromise: estimated fetal weight (efw) \< 5th percentile; or bpp \< 6; or absent or reverse diastolic ua blood flow; or oligohydramnios (mvp \< 2 cm) * placental abruption defined as unexplained vaginal bleeding * preterm labor defined as regular contractions and cervical change * any condition deemed by the investigator to be a risk to mother or fetus in completion of the study * any condition deemed by the investigator to require delivery within 48 hours
innovative approach to reduce lung cancer stigma

Conditions: Lung Cancer Stigma; Lung Cancer; Stigma, Social; Stigmatization; Acceptance Processes

Summary: this is a feasibility study examining the feasibility and acceptability of a novel psychotherapy intervention on lung cancer patients who are experiencing stigma.

experiences of stigma (perception and internalization of negative appraisal and devaluation from others) are pervasive for lung cancer patients. previous work has shown associations between lung cancer stigma and detriments in clinically relevant outcomes such as depression, lower quality of life, and reduced engagement in cancer care. the investigators previously developed acceptance and commitment therapy for lung cancer stigma (act-lcs) as a patient-focused intervention to reduce the self-blame, guilt and inhibited disclosure associated with lung cancer stigma. act-lcs is based in acceptance and commitment therapy (act), a cognitive-behavioral treatment that promotes psychological flexibility through acceptance and valued direction. this is a feasibility study examining the feasibility and acceptability of act-lcs.

Eligibility criteria:
inclusion criteria: * proficiency in english * diagnosed with or treated for non-small cell lung cancer (nsclc) or small cell lung cancer (sclc) within the prior 12 months. * scores of 37.5 on the lung cancer stigma inventory (lcsi) screening measure exclusion criteria: * not proficient in english

Keywords: lung cancer stigma lung cancer stigma acceptance and commitment therapy
outcomes data of adipose stem cells to treat multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual's own fat, known as the stromal vascular fraction (svf), has on the quality of life of people with multiple sclerosis (ms). svf contains components with "regenerative" properties, including stem cells that may be capable of ameliorating specific disease conditions. this study is designed to evaluate quality of life changes in individuals with ms for up to 12 months following svf treatment.


Eligibility criteria:
inclusion criteria: * subjects scheduled for a stem cell/svf treatment * subjects diagnosed with some form of multiple sclerosis * subjects between the ages of 18 and 65 * subjects willing and able to sign informed consent * subjects willing and able to perform follow up interviews and surveys exclusion criteria: * subjects for whom baseline data is not available * subjects with additional major health diagnoses * subjects that are pregnant or breastfeeding
effect of nervus cutaneous femoris lateralis-blockade on moderate pain responders after total hip arthroplasty

Conditions: Pain, Postoperative; Ropivacaine; Therapeutic Use; Arthroplasty, Replacement, Hip

Summary: the patients will be included the 1. or 2. day after surgery. all tha patients will be screened. those reporting vas \> 40 during active 30 degrees hip flexion will be asked to participate. included patients will receive 2xncfl (singleshot) first placebo (8 ml saline) and then ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). there will be 45 minutes between the two blockades. the blockades will be ultrasound guided.


Eligibility criteria:
inclusion criteria: * tha within 48 hours and vas\>40 during active 30 degrees hip flexion despite conventional pain medication. * informed consent * asa 1-3 * bmi 18-40 exclusion criteria: * unable to communicate in danish * allergic reactions toward drugs used * abuse of alcohol/drugs * unable to cooperate * pregnant women

Keywords: us guided nerve block total hip arthroplasty ncfl nervus cutaneous femoralis lateralis
minimally invasive holmium:yag laser blepharoplasty

Conditions: Lower Eyelid Entropion

Summary: the purpose of this research study is to is to evaluate the safety and effectiveness of the fda approved holmium:yag laser for reducing lower eyelid bags.

the researchers are interested in learning if the more precise holmium:yag laser can effectively tighten the orbital septum, a barrier of the orbit which holds fat in the bony orbit, while resulting in less unintentional surrounding damage and side effects.

Eligibility criteria:
inclusion criteria: * male/female 30 years and older * have pronounced lower eyelid fat pads. exclusion criteria: * based on medical problems. * previous surgery or trauma to lower eyelid or orbit. * pregnant or lactating.

Keywords: eyelid fat pads
prone position improves end-expiratory lung volumes in covid-19 acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome; Coronavirus; Mechanical Ventilation Complication; Ventilation Perfusion Mismatch

Summary: covid-19 associated acute respiratory distress syndrome (ards) may present with profound hypoxemia not fully explained with pulmonary infiltrates. accordingly, how prone positioning improves oxygenation in these patients is not fully known. the investigators conducted a study among patients with severe covid-19 ards receiving prone position for at least 16 hours. end expiratory lung volume (eelv) was measured with nitrogen wash-in/wash-out technique before (supine position 1- sp1), during (prone position - pp) and after (supine position 2 - sp2) prone positioning.

after initiation of invasive mechanical ventilation, initial ventilator settings were performed by the attending physician. these settings include titration of best peep to promote oxygenation if spo2 \ 92%. after a period of 30 minutes for stabilisation, the first set of measurements were done in the sp1 position. afterwards, the patient was turned to prone position with the same peep (which was unchanged throughout the study period) and measurements were repeated every four hours until the patient was reverted back to sp2. eventually, there were 7 measurements in total. (sp1, pp0, pp4, pp8, pp12, pp16, sp2). dead space ventilation and shunt fraction calculations were made based on central venous blood gas measurements and oxygen consumption and carbon dioxide production at the relevant timepoint.

Eligibility criteria:
inclusion criteria: * patients were considered eligible if they met the berlin definition criteria for ards and intubated due to increased work of breathing and/or worsening hypoxemia. all patients had a positive covid-19 real time polymerase chain reaction test exclusion criteria: * exclusion criteria were; age \ 2 mmol/l, or an increase in lactate concentrations for 20% in two consecutive blood gas analysis within 2 hours interval) and suspicion or confirmed pulmonary emboli.

Keywords: acute respiratory distress syndrome prone position lung recruitment
economic evaluation of heart failure management in colombian clinics

Conditions: Heart Failure; Asthma

Summary: cost effectiveness analysis of local management of patients diagnosed with heart failure disease compared with an ideal guideline-based management.


Eligibility criteria:
inclusion criteria: * asthma moderate to severe.

Keywords: cost-effectiveness analysis colombia
the application of lidocaine cream on oral secretions of lma removal during the recovery period in ophthalmic surgical patients under general anesthesia

Conditions: Airway Complication of Anaesthesia; Laryngeal Mask Airway Removal; Anesthesia Emergence; Secretion; Excess, Salivation; Ophthalmic Surgery; General Anesthesia

Summary: the application of lidocaine cream on oral secretions of lma removal during the recovery period in ophthalmic surgical patients under general anesthesia: a randomized controlled trial

during the recovery from general anesthesia, patients commonly experience heightened oral secretions, which can elevate intraocular pressure (iop) due to coughing and potentially lead to the infiltration of secretions into the surgical site via the nasolacrimal duct, increasing the risk of endophthalmitis. this study is aimed to investigate whether applying lidocaine cream to the laryngeal mask airway (lma) reduces oral secretions during emergence from general anesthesia in ophthalmic surgery patients.

Eligibility criteria:
inclusion criteria: * aged 18 to 60 years; * with american society of anesthesiologists (asa) physical status i or ii; * scheduled to undergo ophthalmic surgery following general anesthesia with lma. exclusion criteria: * contraindications to lma use; * a history of upper respiratory tract infection within one week prior to surgery; * persistent pharyngeal symptoms (eg. throat irritation, dryness, or chronic cough, etc.) lasting ≥ 3 months; * severe gastroesophageal reflux disease; * morbid obesity, defined as a body mass index ≥ 40 kg/m2; * a predicted difficult airway (eg. a history of difficult airway, mouth opening \< 3 cm, mallampati class 4, limited neck extension or cervical spine disease); * presence of structural abnormalities, masses, infections, or scarring in the oral cavity or oropharynx; * known contraindications to lidocaine cream; * two or more failed attempts at lma insertion; * intraoperative administration of anticholinergic agents; * any other condition present likely to influence the study outcomes.

Keywords: airway complication oral secretions laryngeal mask airway general anesthesia ophthalmic surgery
early and longitudinal assessment of neurodegeneration in the brain and spinal cord in friedreich's ataxia

Conditions: Friedreich Ataxia

Summary: friedreich's ataxia is characterized by progressive alterations in the function of the cerebellum accompanied by an atrophy of the spinal cord. although the genetic defect responsible for the disease has been identified more than 15 years ago, objective markers of the pathologic process (i.e., biomarkers) that would allow measuring the effects of potential therapies are still lacking. moreover, it is still unclear how the malfunction of the cerebellum affects the rest of the brain, and understanding the connectivity and neurochemistry of the central nervous system might yield new insights in the understanding of the disease, in addition to providing potential markers. to address these needs, the investigators aim at utilizing the capabilities of magnetic resonance imaging (mri) and spectroscopy (mrs). using techniques called diffusion imaging, resting-state functional mri, and proton spectroscopy (1h mrs), the investigators propose to determine the differences in the connectivity and neurochemistry of the spinal cord and the brain between patients affected by friedreich's ataxia and healthy controls. the investigators plan on imaging both patients and control subjects using a 3t magnet, a system that although not yet available in all medical facilities, is becoming standard in most hospitals and clinics. the first aim is to scan patients already scanned last year (12-month follow-up). the second aim is to scan patients at an early stage of the disease.


Eligibility criteria:
inclusion criteria: * genetic diagnosis of friedreich's ataxia for patient volunteers with gaa repeat expansion number * absence of neurological conditions for control volunteers * control volunteers will be age-, race-, and gender-matched to the patients exclusion criteria: * claustrophobia * smoking * diabetes * pregnancy or lactation * weight over 300 lbs * presence of a pacemaker or any paramagnetic object in the body * severe scoliosis

Keywords: friedreich ataxia frda fa recessive neurodegenerative cerebellum
a six-week flexible dose study evaluating the efficacy and safety of geodon in patients with bipolar i depression.

Conditions: Bipolar Disorder

Summary: this is a 6-week trial that evaluates the efficacy and safety of geodon (ziprasidone) in outpatient subjects ages 18 and older with bipolar disorder type i, depressed. subjects are required to undergo a washout period of at least 7 days of any prior med.


Eligibility criteria:
inclusion criteria: * subjects must have a primary diagnosis of bipolar i disorder, most recent episode depressed, with or without rapid cycling, without psychotic features, as defined in dsm-iv-tr (296.5x) and confirmed by a structured mini international neuropsychiatric interview (mini) exclusion criteria: * subjects with a dsm-iv tr diagnosis of schizophrenia (295.xx), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder nos (298.9). * subjects with other dsm-iv tr axis i or axis ii disorder (in addition to bipolar i disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6 month period prior to screening.

Keywords: bipolar i depression
"ease" epicardial access with the epiaccess system

Conditions: Arrhythmias, Cardiac

Summary: prospective non-randomized, single arm trial to further evaluate the safety and performance of epiaccess, the study device, for gaining access to the normal, non-distended pericardial space during epicardial diagnostic or therapeutic (ablation) procedures.

prior to enrolment, patients will be evaluated on the basis of the latest available data to establish eligibility. eligible patients will be enrolled in the study by the local principal investigator after informed consent is obtained. as epiaccess is only used for the access portion of electrophysiology procedures, the safety, performance and effectiveness endpoints are acute from the time of needle insertion to pericardial space access (guidewire insertion into the pericardial sac). patients will be followed until hospital discharge. follow-up clinical examinations will be performed in accordance with institutions' standard of care. no special tests are required for this device. patients' completion of study will occur at the time of their hospital discharge, or earlier if patient did not complete the study. the stop criterion for this study is: greater than 25% serious adverse device effect, as defined in this protocol, after enrolment of 10 or more patients, compared to existing data from the literature presenting epicardial access procedure results during sub-xyphoid (minimally invasive) surgical procedures.

Eligibility criteria:
inclusion criteria: 1. patient is 18 years of age or older 2. pericardial access is clinically indicated 3. patient is willing and able to provide written informed consent exclusion criteria: 1. patient with history of cardiac or pericardial surgery in the past 6 months 2. patient with history of chronic pericarditis 3. myocardial infarction within 4 weeks prior to procedure 4. class iv nyha (new york heart association) heart failure symptoms 5. cerebrovascular accident within previous 6 months 6. known carotid artery stenosis greater than 80% 7. presence of thrombus in the left atrium 8. coagulopathy 9. severe hepatic dysfunction or enlargement 10. life expectancy less than 6 months 11. bmi \> 40 12. patient is enrolled in another clinical trial 13. patient is pregnant

Keywords: subxiphoid access