Kornimate/medical-research-clean huggingface dataset:
safety and effects of autologous adipose-derived stromal cells delivered in patients with type ii diabetes

Conditions: Diabetes Mellitus Type II

Summary: this will be an open-label, non-randomized, multi-center, patient sponsored study of adipose-derived stromal vascular fraction cells implantation via intravenous infusion. the intent of this clinical study is to answer the questions: 1) is the proposed treatment safe and 2) is treatment effective in improving the disease pathology of patients with diagnosed type ii diabetes mellitus.


Eligibility criteria:
inclusion criteria: * males and females between age 18 and 80 years. * type 2 diabetes mellitus (as guideline who, 1999); * body mass index (bmi)≤35㎏/㎡; * fast blood glucose (fbg)≥7.0 mmol/l, and hemoglobin a1c (hgba1c)≥7％; * up to date on all age and gender appropriate cancer screening per american cancer society. exclusion criteria: * females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study * life expectancy \< 6 months due to concomitant illnesses. * exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. * active infectious disease. if patients have tested positive, they will be consulted as to patient eligibility based on the patient's infectious status * any illness which, in the investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results * patients on chronic immunosuppressive transplant therapy * systolic blood pressure (supine) ≤90 mmhg or \>180mmhg * resting heart rate \> 100 bpm; * active clinical infection within one week of enrollment. * known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. * history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. * unwilling and/or not able to give written informed consent.

Keywords: diabetes type 2 diabetes
antidiabetic potential of galician high-phenolic extra virgin olive oils in patients with type 2 diabetes mellitus.

Conditions: Diabetes Mellitus, Type 2

Summary: since galician virgin olive oils have a high content of bioactive phenolic compounds and these are attributed to a large part of the healthy properties of the mediterranean diet, our starting hypothesis is that these olive oils could attenuate insulin resistance, improving glycemic control in terms of fasting plasma glucose and/or glycated hemoglobin and insulin sensitivity.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes mellitus for at least 1 year prior to inclusion. * older than 18 years old * current treatment with diet and/or oral hypoglycemic agents (biguanides, thiazolindiones, α-glucosidase inhibitors, idpp4, aglp-1, isglt2). * body mass index ≥ 25 kg/m2 and \< 40 kg/ m2. exclusion criteria: * patients on treatment with insulin, su or rapid-acting insulin secretagogues. * history of severe ketosis or hyperglycemic decompensation. * pregnancy, pregnancy planning or breastfeeding. * body mass index ≥ 25 kg/m2 and \< 40 kg/m2. * difficulty or great inconvenience in changing eating habits or a low predicted probability of changing eating habits. * serious medical condition that may affect the person's ability to participate in a nutritional intervention study (e.g., digestive disease with fat intolerance, malignant disease, or significant neurological, psychiatric, or endocrine disease). * any other medical condition considered to limit survival to less than 1 year. * immunodeficiency or hiv positive status. * illegal drug use, chronic alcoholism or problematic alcohol use or total daily alcohol intake \> 80 g/d. * participation in any clinical trial or use of any investigational drug within the past year. * patients institutionalized for chronic care.
tnferade biologic to treat locally advanced prostate cancer

Conditions: Locally Advanced Prostate Cancer

Summary: while radiation therapy with androgen ablation (hormone reduction) is the standard method of treating locally advanced prostate cancer. new treatments are being combined with radiation therapy in an effort to further improve the cure rates. this study proposes to combine an experimental drug, tnferade™ biologic, (also called adgvegr.tnf.11d or "tnferade") at different dose (amounts) levels in combination with radiation. tnferade™ biologic is a form of gene transfer therapy that when injected into the tumor has shown to increase the effect of radiation therapy.


Eligibility criteria:
inclusion criteria * histological documented high-risk localized prostate cancer defined by clinical stage \>=t3 or gleason score ≥8. * lack of distant metastases (including bone, liver, or extrapelvic lymph node metastases) on standard ct and bone scanning. patients with suspected or histologically confirmed pelvic lymph node metastases are eligible. * normal organ function defined by: * hgb \> 10 mg/dl (may be transfused or on erythropoietin); * platelets \> 100,000/l; * absolute neutrophil count \> 1500/l. * bilirubin \< 1.5 mg/dl. * ast and alt \< 1.5x upper limit of normal. * written signed informed consent. exclusion criteria * absolute or relative contraindication to prostate radiotherapy including but not limited to prior pelvic radiotherapy, active infectious or inflammatory colitis, and inability to lay supine for daily radiation treatments. * requirement for ongoing antithrombotic treatment with coumadin or one of its derivatives, heparin or one of its derivatives, or thrombin inhibitors. low dose aspirin for prevention of cardiovascular events is acceptable. * active vascular disease defined as a stroke, transient ischemic attack (tia), myocardial infarction, or any vascular procedure performed for ischemic disease within the last 6 months. * history of thrombosis (pulmonary embolism (pe) or deep vein thrombosis (dvt)) or known thrombophilia. * coagulopathy (inr\>1.5, ptt ratio \>1.5) * major surgery within the last 1 month (excludes minor superficial surgeries, biopsies, or minimally invasive approaches). * chemotherapy or experimental medications within 4 weeks of study entry. * chronic treatment for greater than 6 months with oral steroids at doses above 10 mg/day prednisolone (or equivalent). * clinical evidence of active infection of any type. * hiv-positive patients receiving combination anti-retroviral therapy. * other significant concurrent medical or psychiatric illness that would limit compliance with study. * unwilling to use condoms or another barrier method of birth control for at least 8 weeks following the last dose of tnferade™ biologic and some form of birth control for at least one year. -

Keywords: prostate tnferade biologic
periodontal regeneration of chronic periodontal disease patients receiving stem cells injection therapy

Conditions: Periodontal Diseases

Summary: the purpose of this study is to evaluate the safety of clinical injection of allogeneic human dental pulp stem cell(dpsc) in local infected periodontal tissue and determine whether injection of allogeneic dpsc is a effective way in the treatment of chronic periodontal disease.

this study will involve 40 patients who were diagnosed as chronic periodontitis will receive periodontal scaling and root planing. patients will randomly be divided at the base line into two groups.in test group, 20 chronic periodontitis patients will be treated using local dpsc injection. whereas, a control group will contain 20 patients who will be treated using placebo. clinical examination including quigley-hein plaque index (qhi), bleeding on probing (bop), probing depth (pd), clinical attachment level (cal), and gingival recession (gr) will be perform in different time points during the study. radiographic and clinical examination will be carried out during the late healing phase up to 12 months post operation.

Eligibility criteria:
inclusion criteria: * diagnosis of periodontal disease will be based on clinical assessment of: * quigley-hein index (qhi) * bleeding on probing (bop) * pocket probing depth (pd) * gingival recession (gr) * clinical attachment level (cal) * furcation involvement,and * radiographical assessment. all patients at the base line of this study should have been received the initial treatment and reached the qualified level of oral hygiene to be included in the next stage. exclusion criteria: * pregnant, * smokers, * immunosuppressed or diabetes patients, * patients exhibit gingival hypertrophy, * require premedication, and * who have been taking systemic anti-inflammatory medications, or * have taken antibiotics or * received periodontal instrumentation within 6 months prior to the study, will be excluded.

Keywords: periodontal diseases bone regeneration dental pulp stem cell
case series_targeted training for trunk control cerebral palsy

Conditions: Cerebral Palsy

Summary: little is known about how children with cerebral palsy (cp) use their sensory systems (touch, sense of body position, balance organs in the inner ear, vision) to help them achieve trunk control for independent sitting. if a child with cp does not achieve trunk control by 4 years of age their prognosis for motor skill development including walking is poor. clinical researchers at the movement centre in oswestry, england have developed a method called targeted training in which children train trunk control in small segments from the top down using a custom fit training device. this study aims to examine how children with moderate to severe cp use sensory information for trunk control before, during and after a program of targeted training.

one of the major challenges of motor control is to understand how the central nervous system controls the degrees of freedom of the body. this is particularly evident in cerebral palsy (cp), which is the most prevalent chronic childhood motor disability and is one of the most disabling and costly chronic disorders of children and adults. deficits in postural control and sensorimotor integration are hallmarks of cp. although postural control of the trunk for independent sitting creates the foundation for all other motor tasks, surprisingly little is known about how children with cp use sensory input to guide their development of upright control (which occurs in typically developing infants by 8 months of age). this lack of knowledge limits our ability to effectively assess and treat children with neuromotor deficits in trunk control. the objectives of this project are to identify sensory reliance and sensory re-weighting in a study of children with moderate-to-severe cp (4-12 years of age) before and after targeted training for trunk control. a novel trunk support device will enable testing of participants who lack (or are still developing) stable sitting. in experiments, kinematics of the head and trunk will be measured. sensory reliance and re-weighting will be identified from postural trunk responses to sensory conflict stimuli consisting of tilts of a visual surround and/or tilts of a surface which participants sit upon. generally, participants with a high reliance on vestibular feedback will remain upright with respect to gravity during all tests; whereas a high reliance on cutaneous or visual feedback will produce trunk sway away from upright and toward the surface or visual surround tilt, respectively. to tease apart biomechanical, physical, and neurological contributions to trunk sway, sensorimotor integration modeling will be used to complement data interpretation.

Eligibility criteria:
inclusion criteria: * cerebral palsy * age 2-12 years * gross motor function classification system (gmfcs) level iii, iv or v exclusion criteria: * spinal fixation * fixed scoliosis * uncontrolled seizures

Keywords: postural control targeted training cerebral palsy sensorimotor control trunk segments
a study of vi-0521 for the treatment of obstructive sleep apnea / hypopnea syndrome in obese adults

Conditions: Sleep Apnea

Summary: the primary objectives of this study are to evaluate the safety and efficacy of vi-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (osa) and to assess the relative contributions of weight loss on parameters of osa in these subjects.


Eligibility criteria:
inclusion criteria: * obese adults 30 - 65 years old (inclusive); * women of child-bearing potential must be using adequate contraception; * bmi between 30 and 40 kg/m2 (inclusive); * diagnosis of osa syndrome with apnea/hypopnea index (ahi) of 15 or greater; * unwilling or unable to comply with cpap treatment; exclusion criteria: * known allergy or hypersensitivity to phentermine or topiramate; * sleep disorder other than osa syndrome; * women who are pregnant, breast feeding, or intend to become pregnant during the study; * presence of unstable angina or heart failure corresponding to nyha functional class iii or iv; * history of myocardial infarction or coronary revascularization within the past year; any history of stroke; * presence of any clinically significant abnormality on electrocardiogram; * use of any prescription cns stimulants; * history of cholecystitis or cholelithiasis unless treated by cholecystectomy; * history of glaucoma or any past or present use of medications to treat increased intraocular pressure; * weight gain or loss of greater than 5 kg, use of a very low-calorie diet, or participation in a formal weight loss program (investigational or otherwise) within the past 3 months; * previous bariatric surgery; * shift workers or any subjects with a circadian rhythm disorder; * professional drivers or commercial pilots; * history of nephrolithiasis; * more than one lifetime episode of major depression; * history of bipolar disorder, obsessive compulsive disorder, borderline personality disorder, psychotic depression, schizophrenia, schizoaffective disorder, or any other psychotic disorder; history of any psychiatric hospitalization; * history of a seizure disorder; concurrent use of any anticonvulsant drug (other than assigned study drug);

Keywords: sleep apnea; obesity
efficacy study of pacemakers to treat slow heart rate in patients with heart failure

Conditions: Heart Failure With a Preserved Ejection Fraction; Heart Failure, Diastolic; Chronotropic Incompetence

Summary: determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (hfpef) and chronotropic incompetence (ci).


Eligibility criteria:
inclusion criteria 1. age \>18 years and able to provide informed consent to enroll in the trial, or consent through a legal guardian or power of attorney. 2. previous clinical diagnosis of hf with current nyha class ii-iii symptoms 3. at least one of the following: hospitalization for decompensated hf, acute treatment for hf with intravenous loop diuretic or hemofiltration, chronic treatment with a loop diuretic for control of hf symptoms + left atrial enlargement on echocardiography or e/e' ratio (≥14 average, ≥15 septal ) on echocardiography, resting pcwp \>15 mm hg or lv end-diastolic pressure \>18 mmhg at catheterization for dyspnea and/or exercise pcwp/lv end-diastolic pressure \>25 mmhg, or elevated nt-probnp level (≥300 pg/ml ) 4. left ventricular ef ≥40% within 12 months with clinical stability 5. stable cardiac medical therapy for ≥30 days 6. sinus rhythm 7. chronotropic incompetence on recent (within 6 months) clinical or screening exercise test, defined as heart rate reserve (hrr) \<0.80 or \<0.62 if on beta blockers 8. meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months. exclusion criteria 1. inability to exercise, or non-cardiac condition that precludes exercise testing 2. any contraindication to a pacemaker system 3. non-cardiac condition limiting life expectancy to less than one year 4. significant left sided structural valve disease (\>mild stenosis, \>moderate regurgitation) 5. hypertrophic cardiomyopathy 6. infiltrative or inflammatory myocardial disease (amyloid, sarcoid) 7. pericardial disease 8. non-group 2 pulmonary arterial hypertension 9. chronic stable exertional angina 10. acute coronary syndrome or revascularization within 60 days 11. other clinically important causes of dyspnea 12. atrial fibrillation 13. pr interval \>210 msec 14. resting heart rate (hr) \> 100 bpm 15. a history of reduced ejection fraction (ef\<40%) 16. advanced chronic kidney disease (gfr \< 20 ml/min/1.73m2 by modified mdrd equation) 17. women of child bearing potential without negative pregnancy test and effective contraception 18. severe anemia (hemoglobin \<10 g/dl) 19. severe hepatic disease 20. complex congenital heart disease 21. listed for cardiac transplantation 22. other class i indications for pacing

Keywords: hfpef heart failure heart failure with preserved ejection fraction chronotropic incompetence
growing little peapods study

Conditions: Premature Birth; Premature Infant; Premature; Intrauterine Growth Restriction; Small for Gestational Age At Delivery

Summary: the goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the neonatal intensive care unit (nicu) influences their ability to gain weight and fat-free mass, and their future growth and development. participants will: * have body growth measurements collected using the peapod device * have nutritional information collected, and * be followed for neurodevelopmental outcomes participants can expect to be in the study for 36 months.


Eligibility criteria:
neonate inclusion criteria: * born inpatient at meriter hospital, inc. at or above 22 gestational weeks. upper limit is 32 weeks 6 days ga (possible gestational age range from 22w0d-32w6d) neonate exclusion criteria: * known genetic condition that impacts neurodevelopmental outcomes or brain structure development * multiple major congenital anomalies * per the investigator's opinion, the subject will likely require transfer to american family children's hospital (afch) before 36 weeks pma * any neonate who enrolls in the study and then unexpectedly requires transfer to afch before 36 weeks pma will be excluded from the study if they are unable to obtain at least one body composition measurement before transfer. body composition data points can only be collected at meriter hospital due to the location of peapod birthing parent inclusion criteria: * birthing parent must speak english or spanish due to consent documents * able to understand and willing to sign a written informed consent document * primary caregiver of a neonate who is eligible to participate in the study * agrees to enroll neonate into the study * willing to comply with all study procedures and be available for the duration of the study * age 15 or older birthing parent exclusion criteria: * subject is unable to provide informed consent, including subjects in foster care and subjects within state custody * does not plan to maintain custody of the child after birth, such as in instances of adoption or surrogacy
effect of indobufen and aspirin on platelet aggregation and long term prognosis in patients with coronary heart disease

Conditions: Stable Coronary Heart Disease

Summary: this study evaluates the effect of indobufen and aspirin on platelet aggregation and long term prognosis in patients with stable coronary heart disease.


Eligibility criteria:
inclusion criteria: 1. 18 years \< age ≤ 85 years; 2. patients with confirmed stable coronary heart disease (must meet at least one of the following conditions); 2.1 a stenosis confirmed by coronary angiography or dual-source ct, but the stenosis of the left main artery (lma) diameter is less than 50%, the stenosis of the left anterior descending branch（lad）is less than 70%, and the stenosis of the two or three coronary arteries diameter is less than 70%, patient has no corresponding evidence of ischemia; 2.2 patients after percutaneous coronary intervention (pci): dual antiplatelet therapy (dapt) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy. 2.3 patients after coronary artery bypass graft (cabg): dual antiplatelet therapy (dapt) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy. 3. willing to sign the informed consent. exclusion criteria: 1. acute coronary syndrome (acs) occurred within 3 months before screening; 2. percutaneous coronary intervention or cabg surgery within 9 months before screening; 3. any other conditions (such as atrial fibrillation, pulmonary embolism, lower extremity venous thrombosis, artificial heart valve, etc.) who need oral or intravenous anticoagulation treatment; 4. in the past 3 months, the arachidonic acid-induced platelet aggregation rate≥ 50%; inhibition rate ≤ 20% in the aspirin combined with clopidogrel treated patients; 5. congestive heart failure or left ventricular ejection fraction \<35%; 6. a positive history of chronic obstructive pulmonary disease (copd); 7. bleeding tendency or severe lung disease; 8. active pathological bleeding; 9. history of intracranial hemorrhage (less than 3 months); 10. allergic to indobufen / aspirin (or any of its ingredients); 11. severe liver injury (transaminases exceeding the upper limit of 2 times and above); 12. pregnancy, lactation and those who have a birth plan; 13. hematological diseases, platelet count \<100000 / mm3 or hemoglobin \<10g / dl; 14. have a history of drug or alcohol abuse in the past 2 years; 15. use of non-steroidal anti-inflammatory drugs (within 3 months); 16. creatinine clearance \<30ml/min;
video game playing on lunch-time food intake in children

Conditions: Exogenous Obesity

Summary: the purpose of this experiment is to investigate the effect of video game playing for 30 minutes on food intake and subjective appetite. the investigators hypothesize that video game playing will affect food intake in children. food intake will be measured at 30 minutes following a glucose (50g glucose in 250ml of water) or sweetened non-caloric (150mg sucralose® in 250ml of water) beverage with or without video game playing. subjective appetite will be measured at 0, 20, 35 and 65 minutes.


Eligibility criteria:
inclusion criteria: * healthy boys with no emotional, behavioral or learning problems exclusion criteria: * girls