Kornimate/medical-research-clean huggingface dataset:
percutaneous sclerotherapy of symptomatic liver hemangioma with bleomycin

Conditions: Hemangioma Liver

Summary: percutaneous sclerotherapy is currently a widely used treatment for subcutaneous low-flow vascular malformations. considered as a low-flow vascular malformation, symptomatic liver hemangiomas could also theoretically be safely and effectively treated by percutaneous sclerotherapy with a mixture of bleomycin and lipiodol. the safety and efficacy of percutaneous sclerotherapy was firstly introduced by the investigator's investigators in 5 patients in a pilot study. the aim of this study is to design and conduct a study to evaluate the safety and efficacy of percutaneous sclerotherapy in a larger sample size with a long term follow-up.

twenty-five patients with symptomatic liver hemangioma will be enrolled after an informed consent being obtained. patients' symptoms related to liver mass, including the pain severity being measured by visual analogue scale, discomfort, early satiety, or nausea will be recorded. liver function tests, coagulation tests, and complete blood count will be checked before the intervention. a triple phase abdominal ct scan with the administration of intravenous contrast medium will also be performed before the procedure. exclusion criteria include hepatic or renal impairment, abdominal symptoms unrelated to a liver mass, uncorrectable coagulopathy, lung fibrosis, allergy to contrast media, systemic infection, liver abscess, and biliary obstruction. patients will be sufficiently hydrated with normal saline before the procedure. corticosteroid and prophylactic antibiotics will be administered before the procedure. antibiotics will be continued for 3 days after the procedure. the liver mass will be punctured under guidance of ultrasonography with a 20- or 22-gauge chiba needle. contrast medium will be injected under fluoroscopy guidance to assess any possible communication with the biliary tree and to evaluate the amount of sclerosing agent which could be safely injected. then, the mixture of bleomycin (bleocin-s; korea united pharm inc., south korea) and lipiodol (ultra-fluid, guerbet, france) will be slowly injected under continuous guidance of fluoroscopy. no more than 45 units of bleomycin and 15 cc of lipiodol will be injected in a single session. any complication taking place during and within 30 days after the procedure will be recorded. liver function tests, coagulation tests, and complete blood count will be repeated the day after the procedure, and 6 months after the procedure. also, a triple phase abdominal ct scan will be repeated in 6 months, and 12 months after the intervention. the patients' symptoms will be asked by phone after 12 months. the changes in lesion size on ct scan and in patients' symptoms will be evaluated.

Eligibility criteria:
inclusion criteria: * patients with symptomatic liver hemangioma exclusion criteria: * hepatic or renal impairment * abdominal symptoms unrelated to a liver mass * uncorrectable coagulopathy * lung fibrosis * allergy to contrast media * systemic infection * liver abscess * biliary obstruction
clinical trial scheme of shu gan yi yang capsule

Conditions: Depression With Erectile Dysfunction

Summary: shu gan yi yang capsule is made of traditional chinese medicine guizhou yi bai pharmaceutical limited by share ltd, for liver and kidney deficiency and liver and kidney deficiency and blood stasis caused by functional impotence and mild arterial insufficiency in impotence, impotence, flaccid penis not hard or lift and not firm, chest deep sigh, chest fullness, soreness and weakness of waist and knees, pale tongue or petechiae, pulse string or string. the choice of depression associated with erectile dysfunction patients, and investigate its effect.in this study, patients with depression and erectile dysfunction were selected and the efficacy was investigated

the study is a placebo-controlled clinical trial, 160 patients with depression and erectile dysfunction were selected for 8 weeks of observation

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for western medicine in depression; 2. madrs score ≥ 12 points and \<30 points; 3. diagnostic criteria for western medicine in line with erectile dysfunction，iief -5≤21points; 4. tcm syndrome differentiation of liver depression and kidney deficiency in accordance with depression and erectile dysfunction; 5. male subjects, aged 22-65 years old; 6. patients who have not been treated with antidepressants or have been treated with antidepressants for more than 1 months and have reached treatment doses have no need to adjust their medications and dosages within 2 months; 7. the relationship between patients and sexual partners is stable (at least in the last 6 months); 8. volunteer to participate in clinical trials, and sign informed consent. exclusion criteria: 1. a patient with major depressive disorder with psychotic symptoms or suicidal behavior; 2. a genital anatomical abnormality (such as severe penile fibrosis) or other organic sexual dysfunction with apparent impairment of erection; 3. erectile dysfunction due to organic disease; 4. unwilling to stop other patients for depression or erectile dysfunction therapy; 5. a person who has allergies or is sensitive to the ingredients of this test; 6. combined with severe primary liver and kidney diseases, aspartate aminotransferase , alanine aminotransferase exceeded 1.5 times the normal value, and creatinine exceeded the normal limit; 7. a patient with severe somatic disease; 8. patients who have participated in other clinical trials in the past four weeks; 9. a history of drug abuse or alcoholism; 10. the researchers believe that patients who are not eligible for clinical trials are not eligible for clinical trials.

Keywords: depression erectile dysfunction shu gan yi yang
follow-up study to assess safety and clinical activity of continued affitope® ad02 vaccinations of patients who participated in aff006

Conditions: Alzheimer´s Disease

Summary: this is a follow-up study to assess safety and clinical activity of continued affitope® ad02 vaccinations in patients with alzheimer's disease. patients, who have already participated in aff006 will be involved in 27 study sites in europe. duration of patient's participation in the clinical trial is 19 months.


Eligibility criteria:
inclusion criteria: * patients having participated in aff006+having received 6 investigational medicinal product (imp) injections+having completed all visits * written informed consent * availability of a partner/caregiver * female patients of childbearing potential are eligible if they use a medically accepted contraceptive method. * scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial. exclusion criteria: * pregnant women. * sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects. * participation in the active treatment phase of another clinical trial except aff006 within 3 months before visit 0. * history of questionable compliance to visit schedule; patients not expected to complete the clinical trial. * presence or history of allergy to components of the vaccine, if considered relevant by the investigator. * contraindication for mri imaging * presence and/or history of immunodeficiency (e.g., hiv infection). * prior and/or current treatment with experimental immunotherapeutics including intravenous immunoglobulin (ivig), ad antibody therapy and/or vaccines for ad except ad02. * prior and/or current treatment with immunosuppressive drugs. * treatment with benzodiazepines and/or nootropics administered at high doses and/or as newly started treatment. * treatment with anticholinergic drugs including parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases.

Keywords: affitope® ad02 alzheimer disease dementia brain disease nervous system diseases tauopathies neurodegenerative diseases mental disorders
nutritional therapy in patients at risk for malnutrition and sarcopenia in pulmonary rehabilitation

Conditions: Sarcopenia; Malnutrition

Summary: malnutrition and sarcopenia (muscle wasting) are common in health care settings and represent a health and economic burden due to associated increased mortality and prolonged hospital stays. nutritional therapy co-management is recommended for both diagnoses. this study investigates the efficacy of individualized nutrition therapy (int) in pulmonary rehabilitation. patients at significant risk for malnutrition already receive int within clinical routine during rehabilitation. the investigators will investigate if patients with only mild to moderate risk of malnutrition and possible sarcopenia also benefit from int.

the participating patients are randomly assigned to two groups after giving written consent. the intervention group receives individual counseling by nutrition therapists twice a week in addition to the usual rehabilitation program. the int determines the energy and protein needs of the patients and creates targeted individual measures to achieve them. measures may include, for example, adjustments to the meal plan or nutritional supplementation. the measures are continuously adapted to the patients' needs. the control group also receives soup fortified with a standard amount of protein and fat and, if needed, an energy- and protein-rich dessert option as part of the rehabilitation routine care for patients at risk for malnutrition. however, patients from the control group do not receive additional counseling or adjustment by the int. patients' energy and protein intake will be recorded on three subsequent days at start of rehabilitation and at three subsequent days before discharge. average duration of rehabilitation is expected to be three weeks. as primary outcome, change in energy intake will be compared between groups. additionally, change in protein intake and other follow-up parameters of nutritional status and sarcopenia will be examined.

Eligibility criteria:
inclusion criteria: * admission to rehab due to chronic obstructive pulmonary disease or after a pneumonia * light to moderate risk of malnutrition (nutritional risk score-2002: 3-4 points) * risk of sarcopenia (sarc-f \>=4) * signed informed consent exclusion criteria: * medically described nutritional support * reasons (cognitive, language) that prevent a informed consent * enteral or parenteral nutrition * after bariatric surgery

Keywords: individual nutrition therapy
utility of placental/umbilical cord blood in early onset neonatal sepsis in very low birth weight infants

Conditions: Preterm Infant; Early-Onset Neonatal Sepsis; Umbilical Cord

Summary: this study evaluates the utility of placental/umbilical cord blood (pucb) to perform the baseline workup testing for eons in very low birth weight infants: cbc (complete blood count) with differential, immature/total ratio (i/t ratio), and blood culture along with crp and il-6 levels. a cohort (63 subjects) of preterm infants will be recruited. all the participants will be evaluated for sepsis using placental/umbilical cord blood (pucb) and subject blood sample during the first 12 hours of life (after birth).

early onset neonatal sepsis (eons) is common in preterm infants, and it is associated with high morbidity and mortality, especially if not diagnosed early. currently the baseline workup is done using blood samples from the infant to perform blood culture, cbc, i/t ratio. these tests have shown to have low sensitivity and specificity to diagnosis eons. pucb can be another safe source of blood which is useful, painless and simple to collect. as cbc, i/t ratio and blood culture may not be enough to diagnose eons we will add il-6 and crp which will increase sensitivity and specificity to diagnose eons in preterm infants without collecting blood from the infants. this study may be a step to decrease iatrogenic blood loss to diagnose eons. the primary outcome of the current research will be to find out the utility of pucb in diagnosing eos in preterm infants (\<30 weeks and \<1250 grams birth weight). using pucb can increase the accuracy to diagnose sepsis in preterm infants, and it will also conserve blood in the extremely premature infants while reducing hemodynamic instability due to acute blood loss.

Eligibility criteria:
inclusion criteria: * infants \<34 weeks' gestational exclusion criteria: * known congenital or chromosomal anomalies * congenital heart disease (other than patent ductus arteriosus, patent foramen ovale or atrial septum defect) * vaginal bleeding at admission

Keywords: preterm infant early-onset neonatal sepsis umbilical cord complete cell count placenta blood culture
a feasibility study for elective cardioversion of atrial fibrillation at home

Conditions: Emergency Medical Services; Electric Countershock

Summary: the goal of this pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home dc-ecv in the treatment of recurrent symptomatic af performed by app in 25 patients. the main question\[s\] it aims to answer are: primary objective: in this prospective intervention feasibility study, in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm. (% of study patients with a recurrence of af in whom a home cardioversion is performed, i.e. to whom at least one dc shock was administered while the patient was under sedation). feasibility endpoints are ; (a) evaluation of enrolment of participants, (b) evaluation and refinement of data and outcome collection procedures, (c) evaluation of logistics, (d) evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention, and (e) preliminary evaluation of participant responses to the intervention. secondary objectives: safety endpoint: complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation). a composite of major adverse cardiovascular and cerebrovascular events (macce) occurring within 24 hours macce occurring during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up; number (%) of patients in sinus rhythm at 1 hour in the post-shock observation period; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care.


Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. age 18 -75 year subjects, able to understand the provided information and sign an informed consent. 3. need for direct current electrical cardioversion (dc-ecv) for correction of recurrent symptomatic af (according to the guidelines of the american college of cardiology/american heart association/european society of cardiology (acc/aha/esc)). 4. weight more than 50 kilograms. 5. successful hospital dc-ecv for a previous episode of af performed under propofol sedation. 6. target range of international normalized ratio (inr) above 2.0, when on vitamin k antagonists, or use of novel oral anticoagulant, stable for 3 weeks. 7. asa 2. 8. bmi \< 35 kg/m2. 9. fasting status: at least 6 hours for food, and 2 hours for fluids. exclusion criteria: * 1. patients over 75 years old and younger than 18 years. 2. patients wearing pacemaker or implantable cardioverter-defibrillator. 3. patients with (cardiovascular): sick sinus syndrome, ventricular pre-excitation, brugada syndrome or bundle branch block. severe ischemic or valvular heart disease. known second or third degree atrioventricular block normal sinus rhythm. heart failure nyha iii or iv, known lvef \< 35%, or cor pulmonale. transient and reversible cause of af, e.g. in setting of fever and hyperthyroidism.

Keywords: atrial fibrilation dc-ecv
diabetes prevention and control in the workplace: a pilot study

Conditions: Type 2 Diabetes Mellitus

Summary: this worksite program for onondaga county employees is a pilot research study aimed at decreasing the risk of developing diabetes (or improving metabolic control for adults with diabetes). the main goal is to improve the nutrition and physical habits of the participants, and promote weight loss in those who are overweight. the investigators will also examine factors that predict participation in the program and influence a participant's outcome/success in the program.


Eligibility criteria:
inclusion criteria: * adult employees of onondaga county exclusion criteria: * not an employee of onondaga county * less than age 18

Keywords: diabetes mellitus obesity prevention
an open-label continuation study evaluating the long-term safety of extended release ropinirole xl (formerly cr) in parkinson''s disease

Conditions: Parkinson Disease; Parkinson's Disease

Summary: to evaluate the safety profile of ropinirole xl during long-term treatment in subjects with early and advanced parkinson's disease


Eligibility criteria:
inclusion criteria: a subject will be eligible for inclusion in this study only if all of the following criteria apply: * subjects must have completed requip studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week down titration at the end of treatment/early withdrawal). * subjects must not have a break in medication between completing the feeder study (including the down titration phase for studies 168 and 169) and beginning treatment in study 248. * women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (iud), or diaphragm in addition to spermicidal foam and condom on male partner, or systemic contraception (e.g. norplant system). * provide written informed consent for this study. * be willing and able to comply with study procedures. exclusion criteria: a subject will not be eligible for inclusion in this study if any of the following criteria apply: * patients with any ongoing clinically significant adverse events at the end of the "feeder" studies. * subjects with severe, clinically significant condition(s) other than parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma). * subjects with clinically significant abnormalities in laboratory or ecg tests at the end of the feeder study (requip study 165, 168 or 169). * subjects with severe dizziness or fainting due to postural hypotension on standing. * withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit cytochrome p 450 1a2 (cyp1a2 \[e.g. ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol\]) or induce cyp1a2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period. * women who are pregnant or breast-feeding. * use of an investigational drug throughout the treatment period.

Keywords: ropinirole xl requip parkinson's disease long term safety efficacy safety ropinirole cr ropinirole ir open-label
effectiveness and safety of electroacupuncture on poststroke urinary incontinence

Conditions: Urinary Incontinence; Stroke, Complication

Summary: this pilot protocol is aimed to evaluate the effectiveness and safety of electroacupuncture therapy for the post-stroke patients with urinary incontinence.


Eligibility criteria:
inclusion criteria: 1. male or female aged over 19 years old 2. patients diagnosed with stroke (cerebral hemorrhage or infarction) by the examination of computed tomography or magnetic resonance imaging methods within 2 years 3. twice or more of urination with 3 to 4 points of ppius\* at baseline or 13 points or more of k-ipss\* 4. any volunteers who signed the informed consent forms exclusion criteria: we will exclude any patients with 1. once or more of post-voiding residual \> 200 ml per day 2. clinically significant stress urinary incontinence diagnosed based on cough induction test or investigator's decision 3. recurrent urinary tract infection defined as 4 or more treatments for urinary tract infection for the recent 1 year 4. cognitive impairment with less than 23 points of mmse-k\* examination 5. acute or chronic lower urinary tract infection examined by urine culture 6. urinary incontinence diagnosed before the stroke occurred and the symptoms have continued until now based on medical history 7. any severe diseases in lower urinary tract based on medical history and screening examination 8. coagulation disorders based on medical history 9. peripheral arterial diseases, which resulted in taking medical or surgical procedures to treat them based on medical history 10. psychiatric diseases based on medical history 11. fear of acupuncture based on questionnaire test 12. pregnancy based on urine test 13. any other inappropriate reasons on which the primary or sub investigators do not let the patients participate in the trial * abbreviations ppius; patient perception of intensity of urgency scale k-ipss; the korean version of international prostate symptom scale mmse-k; the korean version of mini-mental state examination

Keywords: urinary incontinence electroacupuncture stroke complications randomized controlled trial pilot projects
neurofeedback intervention for reading deficits in subacute stroke

Conditions: Stroke; Dyslexia, Acquired

Summary: the overall goal of this project is to advance a biologically-based approach to treatment of reading disorders after stroke, which will expand the limits of cognitive rehabilitation. using a novel brain imaging technique, called real-time functional magnetic resonance imaging (fmri) neurofeedback combined with right hand motor imagery, this project will re-instate brain activity in the left language-dominant hemisphere. stroke patients will practice modulating their own brain activity using fmri neurofeedback signal and will select the most effective mental strategies that help them maintain brain activation patterns associated with better reading recovery.


Eligibility criteria:
inclusion criteria: * first-ever left-hemisphere stroke \< 3 months prior to study recruitment or healthy volunteer * age: 18 - 80 years old * fluent and literate in english prior to stroke * reading deficits, defined as \>3 errors on the paragraphs test (subtests viii, ix) of the reading comprehension battery for aphasia-2nd ed. (rcba-2) in keeping with the healthy control accuracy criterion of 86-100% correct. exclusion criteria: * inability to consent or complete study tasks * inability to undergo mri (e.g., pregnancy, non-mri compatible implants, claustrophobia) * a history of prior neurological disease (e.g., brain tumor, alzheimer's disease)