Kornimate/medical-research-clean huggingface dataset:
safety & efficacy of adipose-derived regenerative cells in the treatment of chronic myocardial ischemia (athena ii)

Conditions: Myocardial Ischemia

Summary: this is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.

to assess the safety and efficacy of adipose-derived regenerative cells (adrcs) delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for percutaneous or surgical revascularization.

Eligibility criteria:
inclusion criteria: 1. males or females \> 20 and \< 80 years of age 2. significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization 3. ccs angina functional class ii-iv and/or nyha stages of heart failure class ii or iii 4. on maximal medical therapy for anginal symptoms and/or heart failure symptoms 5. hemodynamic stability (sbp ≥ 90 mm/hg, hr \<110) 6. ejection fraction ≥ 20% and ≤ 45% 7. inducible ischemia using an objective assessment of ischemia within 1 year of screening (i.e. exercise ecg changes, spect) 8. left ventricular wall thickness ≥ 8 mm at the target site for cell injection exclusion criteria: 1. atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate 2. unstable angina 3. lv thrombus, as documented by echocardiography 4. planned staged treatment of cad or other intervention on the heart 5. platelet count \< 100,000/mm3 6. wbc \< 2,000/mm3 7. tia or stroke within 90 days prior to randomization 8. icd shock within 30 days prior to randomization 9. any condition requiring immunosuppressive medication 10. a high-risk acute coronary syndrome (acs) or a myocardial infarction in the 60 days prior to randomization 11. revascularization within 60 days prior to randomization 12. inability to walk on a treadmill except for class iv angina patients who will be evaluated separately 13. hepatic dysfunction, as defined as aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \> 1.5 times the upper limit of normal range (x uln) 14. hemoglobin ≤ 10.0 g/dl

Keywords: ischemic heart disease coronary artery disease chronic heart failure cardiovascular disease adult stem cells adipose derived regenerative cells
study of the prevalence of polymyositis and dermatomyositis in normandy

Conditions: Polymyositis; Dermatomyositis

Summary: polymyositis and dermatomyositis are characterized by the association to a myopathic syndrome, inflammatory infiltrates in the skeletal muscle. they remain, even today, an important factor of morbidity and mortality in these patients. at present, studies that evaluated the prevalence of polymyositis / dermatomyositis are very few; they were mainly recorded in the united states and japan, the prevalence of polymyositis / dermatomyositis has been estimated between 3.5 and 21.5 cases / 100 000 (according to the old diagnostic criteria of bohan and peter). however, previous works are old and retrospective; above all, they have almost always been performed (90% of cases) from cases reported to the hospital, leading to selection bias and an underestimate of the true prevalence of polymyositis / dermatomyositis in the general population. thus, these data lead to achieve this epidemiological study, descriptive, multicenter, based on the population of normandy.


Eligibility criteria:
inclusion criteria: * patients with polymyositis / dermatomyositis, meeting the diagnostic criteria for enmc; * patient living normandy ; * patient has been informed and has given its verbal agreement ; exclusion criteria: * patients with myositis diagnosed before inclusion (including pathophysiology, clinical phenotype and therapeutic care are different from polymyositis / dermatomyositis)
images in extracranial artery stenosis

Conditions: Extracranial Atherosclerosis

Summary: the goals of this trial are: 1. to compare the sensitivity and specificity of various tools including doppler and magnetic resonance imaging (mri) for diagnosing vertebral artery stenosis and carotid artery stenosis. the positron emission tomography (pet)/mri fusion imaging will be a promising tool to provide both anatomical and functional imaging for vulnerable plaques. 2. to identify patients at high risk of plaque rupture by image studies, biomedical profile, and gene expression of circulating monocytes.


Eligibility criteria:
inclusion criteria: * patients with symptomatic extracranial atherosclerosis who are going to receive angiography and possible intervention. exclusion criteria: * acute systemic illness * creatinine \> 3 mg/dl * unable to tolerate the tests (including mri and pet/computed tomography \[ct\] scans)

Keywords: extracranial atherosclerosis imaging biomarkers
combination chemotherapy in treating patients with myelodysplastic syndrome

Conditions: Leukemia; Myelodysplastic Syndromes

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more cancer cells. chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. purpose: phase ii trial to study the effectiveness of combining topotecan and cytarabine given with amifostine in treating patients who have myelodysplastic syndrome.

objectives: * determine the toxic effects of amifostine, topotecan, and cytarabine in patients with poor risk myelodysplastic syndrome. * determine the hematologic response rate, cytogenetic response rate, and the rate of polyclonal hematopoiesis following this treatment regimen. * determine the duration of response and time to disease progression following this treatment regimen in these patients. outline: patients receive topotecan by continuous iv over 24 hours plus cytarabine iv over 2 hours, on days 1-5. patients receive amifostine iv over 15 minutes every other day for a maximum of 60 days. patients may receive a second course of the same regimen 8 weeks after the first. patients are followed at least monthly for 2 years, then every 3-6 months until death. projected accrual: approximately 25 patients will be accrued for this study within 1 to 1.5 years.

Eligibility criteria:
disease characteristics: * histologically confirmed poor risk myelodysplastic syndrome, including at least one of the following: * bilineage cytopenia * unfavorable cytogenetic abnormalities * refractory anemia with excess blasts and/or refractory anemia with excess blast in transformation (greater than 5% blast) * at least 0.5 on the international prognostic score system * no chronic myelomonocytic leukemia * no hypocellular myelodysplastic syndrome (marrow cellularity less than 30%) patient characteristics: age: * 16 and over performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * absolute neutrophil count less than 1,500/mm3 * platelet count less than 100,000/mm3 * hemoglobin less than 10 g/dl hepatic: * alt less than 5 times upper limit of normal renal: * creatinine no greater than 1.4 mg/dl cardiovascular: * no congestive heart failure other: * not pregnant or nursing * fertile patients must use effective contraception * must have right atrial catheter inserted prior concurrent therapy: biologic therapy: * no prior blood or bone marrow transplantations chemotherapy: * no prior acute myeloid leukemia chemotherapy (except hydroxyurea or low dose cytarabine) * no prior topotecan * no prior amifostine endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * at least 24 hours since prior antihypertensive medication prior to amifostine

Keywords: refractory anemia with excess blasts refractory anemia with excess blasts in transformation de novo myelodysplastic syndromes secondary myelodysplastic syndromes childhood myelodysplastic syndromes
eeg@home (phase 3a of the project, comparison of eeg-recordings)

Conditions: Epilepsy

Summary: the goal of this project is the development of an eeg-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality eeg signals. the purpose is to use the eeg-cap to investigate clinical neurological disorders (e.g. epilepsy). the eeg-cap could also be used at home so that hospital admission in the emu can be avoided for some patients and an increasing number of patients can be examined. phase 3 of the project will be divided into a phase 3a and phase 3b. phase 3a of the project will comprise of an eeg-registration with the different types of electrodes in epilepsy patients with prominent interictal epileptiform discharges (ieds) on eeg. for each epilepsy patient the eeg-recording with dry electrodes will be compared to the eeg-recordings with conventionally used wet electrodes (bridge and cup electrodes). each eeg-recording will take approximately 10 minutes. minimum 2 - maximum 10 epilepsy patients will be included. there will be an visual and clinical evaluation of the eeg-signals (blinded) and a technical evaluation of the eeg-signals. user experience will also be collected.


Eligibility criteria:
inclusion criteria: * epilepsy patients with prominent interictal epileptiform discharges (ieds) on eeg exclusion criteria: * epilepsy patients with no prominent interictal epileptiform discharges (ieds) on eeg
therapist and parent delivered reciprocal imitation training for young children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to examine whether adding a parent education component to an existing intervention (reciprocal imitation training) results in improved outcomes for children with autism spectrum disorder. reciprocal imitation training (rit) is a behavioral intervention designed to improve spontaneous imitation skills in young children with autism spectrum disorder (asd). previous research suggests that it can be effective when used by trained therapists, teachers, siblings, and parents of children with asd. however, it is unclear to what extent training parents to use rit strategies in the home environment may enhance outcomes, compared to having therapists implement rit individually with the child. the study will compare two different versions of rit for young children with asd: (1) two 60-minute weekly sessions of therapist-implemented rit and (2) one weekly 60-minute session of therapist-implemented rit and one weekly 60-minute session of parent education about using rit in the home environment. the investigators will examine child and family outcomes between these two intervention types. outcomes examined will include: (1) spontaneous and prompted imitation skills in the child with asd, (2) social communication skills in the child with asd, (3) parent stress, and (4) parent and child behaviors during parent-child play interactions.


Eligibility criteria:
inclusion criteria: * have a community diagnosis of autism spectrum disorder (as reported by parent) * meet cutoff for "autism" or "autism spectrum" on the autism diagnostic observation schedule, 2nd edition * be between 24 and 60 months of age at the time of study enrollment * demonstrate difficulties with imitation skills on the motor imitation scales and/or the unstructured imitation assessment during pre-treatment assessments exclusion criteria: * participants must not be the sibling of another study participant
angiomatoid fibrous histiocytoma: a single institution case-series

Conditions: Angiomatoid Fibrous Histiocytoma

Summary: single institution cases series review of histological and clinical data

single institution cases series review of histological and clinical data investigators will retrieve from the archives of the rizzoli institute all the cases with a histological diagnosis of angiomatoid fibrous histiocytoma. in all cases with enough available material, immunohistochemistry will be performed on slides/formalin-fixed paraffin-embedded tissue tumor material.

Eligibility criteria:
inclusion criteria: * male and female patients treated at rizzoli institute from 01 january 2006 to 31 december 2017 * diagnosis of angiomatoid fibrous histiocytoma * histological slides/formalin-fixed paraffin-embedded tissue tumor (ffpe) blocks from archive available to perform the histology analysis * written informed consent prior to any study-specific analysis and/or data collection exclusion criteria: • patients with histological diagnosis different from angiomatoid fibrous histiocytoma
dropout factors in chronic pain management

Conditions: Chronic Pain

Summary: chronic pain concernes one in four adults in belgium. because of the psychological and social repercussions, a biopsychosocial approach is necessary in order to improve the quality of life chronic pain patients. non-pharmacological techniques such as hypnosis, self-care learning, music-therapy and psycho-education are gaining more and more interest in the scientific field. however, a major problem in clinical research is patient dropout. to our knowledge, no study has investigated dropout rates in hypnosis clinical research. the aim of this study is, therefore, to better understand the predictors of dropout in several non-pharmacological treatments in chronic pain management.


Eligibility criteria:
inclusion criteria: * major * fluency in french * chronic pain diagnosis exclusion criteria: * neurologic disorder * psychiatric disorder * drug addiction * alcoholism
quality of life study for adult patients with acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: acute lymphoblastic leukemia (all) accounts for about 20% of adult leukemias. treatment results in adult all have lagged behind the improvements achieved in the pediatric population. a modified version of the dana farber cancer institute pediatric protocol is used to treat adult patients with all. the results seem to be superior to those reported with other adult protocols. however, there is limited data on the impact of such intensified approaches and resulting toxicities on the quality of life (qol) of these survivors. identifying important factors affecting the qol may permit attempts at early interventions and may help to further modify the regimen and mitigate these adverse effects on qol. this study is evaluating the quality of life of long term survivors of adult all. it involves the patients filling out several questionnaires that are well-validated measures assessing various qol issues of concern to these patients. the following questionnaires are used in this study: * eortc qlq c30 to assess global health and major health domains * brief pain inventory (bpi) * personal health questionnaire (phq9) to assess psychosocial distress * functional assessment of cancer therapy (fact) fatigue questionnaire * peripheral neuropathy questionnaire the data obtained from the questionnaires will be analyzed and the various domains of health will be quantified.


Eligibility criteria:
inclusion criteria: * previously diagnosed with adult all or t-lymphoblastic lymphoma * age \>/= 18 * have completed the two-year modified dfci protocol at least three months earlier and are in continuous complete remission * understand english and are able to fill out questionnaires
impact of a diabetes education mobile web application on patients with uncontrolled type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Diabetes Education; Lifestyle Modification

Summary: the goal of this clinical trial is to evaluate the use and effectiveness of a mobile web application (app) that is designed to educate and allow patients to manage diabetes and make sustainable lifestyle changes, and to study the impact of the app on clinical outcomes of diabetes (ha1c) and educational outcomes (self-efficacy for diabetes scale). the main question to answer is: does the use of the diabetes application significantly affect clinical outcomes of diabetes and cardiometabolic risk factors (bmi and blood pressure)? patients will be enrolled in one of two available arms of the study. participants in the 'intervention arm' will use the app to view educational information presented as videos in the following areas: healthy coping, healthy eating, staying active, medications (use and safety), problem solving in diabetes and disease pathophysiology. they will continue routine follow-up care with their primary care physicians during the study. participants in the 'control arm' will continue with their primary care physician in routine follow-up care, as normally scheduled. researchers will compare the intervention arm participants to the control arm participants to find out about and compare changes in ha1c, systolic blood pressure, diastolic blood pressure, and body mass index. groups will also be compared on the basis of self-perceived confidence of managing their diabetes by way of the diabetes self efficacy scale.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of type 2 diabetes with ha1c \>8.0 * current patients of the family healthcare center, reading hospital tower health. exclusion criteria: * identified special populations (pregnancy or individuals currently incarcerated) * patients without access to their own smart phone * any patient who is unable to provide their own informed consent to participate in the study

Keywords: type 2 diabetes type ii diabetes uncontrolled type 2 diabetes hyperglycemia mobile web application diabetes education
changing population salt consumption in lithgow, australia

Conditions: Blood Pressure; Hypertension; Cardiovascular Disease

Summary: the objective of this study is to determine whether a community-based salt reduction program can reduce average salt consumption levels. baseline levels of salt consumption were measured in 2011, the salt reduction program was then implemented, and now in 2014 investigators are remeasuring salt consumption levels in the community. the hypothesis investigators are testing is that the salt reduction program will have led to a change in salt consumption levels between 2011 and 2014. the study is being done in lithgow, a regional town in new south wales , australia.

the primary objective of this project is to determine whether there have been changes in average salt consumption levels in the lithgow population from 2011 to 2014. the primary null hypothesis to be tested is that there will be no difference between the mean 24-hour urinary sodium excretion levels between 2011 and 2014. the sample of 419 individuals with 24-hour urine samples in the baseline survey and 600 individuals in the follow-up survey will provide 80% power to detect a difference of 0.7 g/day salt between the mean levels of excretion before and after the intervention. there will be more than 95% power to detect a difference of 1.0 g/day salt or greater.

Eligibility criteria:
inclusion criteria: * all adults over the age of 20 years residing in the lithgow area are eligible * no exclusion based on inter-current illness, use of medications or any other aspect of demography or personal history.

Keywords: dietary sodium urinary sodium excretion urinary iodine excretion
optimal timing for repair of left to right shunt lesions

Conditions: Ventricular Septal Defects; Persistent Common Atrioventricular Canal

Summary: the purpose of this study is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals.

in the past, children with left-to-right shunt lesions such as ventricular septal defects and atrioventricular canal defects were palliated with a pulmonary artery band. this prevented injury to the pulmonary vasculature while the child grew to a size where complete repair could be undertaken. with the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. these operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary heart failure and medication requirements. the primary aim is to determine the optimal timing for repair of left-to-right shunt lesions such as ventricular septal defects and atrioventricular canals. the secondary aim is to define the criteria for failing medical anti-congestive heart failure therapy. this study will be conducted through a retrospective chart review.

Eligibility criteria:
inclusion criteria: * patients in the congenital surgery database * patients who have undergone repair of ventricular septal defects * patients who have undergone repair of atrioventricular canal defects

Keywords: pediatric health cardiac pediatric population congenital heart surgery left to right shunt lesions heart surgery atrioventricular canal defects
a study of dinaciclib in combination with rituximab in participants with chronic lymphocytic leukemia and small lymphocytic lymphoma (p07974)

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: the purpose of this study is to determine the maximum-tolerated dose (mtd) of dinaciclib therapy in combination with rituximab in chronic lymphocytic leukemia (cll) and small lymphocytic lymphoma (sll).


Eligibility criteria:
inclusion criteria: * must have received at least one prior therapy that includes either fludarabine or equivalent nucleoside analogue or an alternative regimen * diagnosis of chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) * eastern cooperative oncology group (ecog) performance status ≤ 2 * women of child-bearing potential who are sexually active, ,including both female subjects and the female sexual partners of male subjects, must agree to use a medically accepted method of contraception prior to enrollment, while receiving protocol-specified treatment, and for 12 months after stopping study treatment. * women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study. * life expectancy ≥12 weeks exclusion criteria: * symptomatic brain metastases or primary central nervous system malignancy * treatment with any chemotherapy or biologic therapy within 4 weeks prior to enrollment * non-hematological toxicities from prior therapy * presence of any serious or uncontrolled infection defined as infection requiring hospital admission and/or parenteral antibiotics * known human immunodeficiency virus (hiv) infection or a known hiv-related malignancy * clinically active hepatitis b or c defined as disease that requires therapy * women who are breast-feeding, pregnant, or intend to become pregnant * prior allogeneic bone marrow transplant (auto hematopoietic stem cell transplantation \[hsct\] is allowed if fully recovered) * prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the subject is considered by his or her physician to have a 2 year survival expectation * any investigational drugs within 4 weeks prior to the start of treatment * concurrently receiving treatment in any other clinical study * previously treated with a cyclin dependent kinase (cdk) inhibitor (e.g., dinaciclib or flavopiridol) * active autoimmune anemia or idiopathic thrombocytopenic purpura (itp) unless stable, defined as being responsive to corticosteroids or other standard therapy