Kornimate/medical-research-clean huggingface dataset:
motion, safinamide in early idiopathic parkinson's disease (ipd), as add-on to dopamine agonist (extension of trial 27918)

Conditions: Idiopathic Parkinson's Disease

Summary: parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. the understanding that pd is a syndrome of dopamine (da) deficiency led to the introduction in the clinical practice of l-dopa, a precursor of da that crosses the blood brain barrier, and also to the use of selective inhibitors of mao b, the major da metabolising enzyme in man. this is a double-blind, placebo-controlled, extension trial, parallel-group, randomised, multi-centre, multi national, phase iii trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic parkinson's disease. the principal objective is to evaluate the time to first intervention, as some previous data suggested that safinamide may delay the need for further dopaminergic supplementation.


Eligibility criteria:
inclusion criteria: 1. the subject completed 24 weeks of trial 27918. 2. the subject successfully completed all trial requirements in trial 27918. 3. if female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. for the purposes of this trial, women of childbearing potential are defined as: "all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive". 4. subject is willing and able to participate in the trial and has provided written, informed consent exclusion criteria: 1. if female, the subject is pregnant or lactating. 2. the subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator's opinion. 3. the subject has shown clinically significant deterioration during participation in trial 27918. 4. motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication. 5. the investigator deems it is not in the subject's best interest to participate to trial 27938 6. signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
preparation of patient autologous induced pluripotent stem cell-derived retinal cells for amd

Conditions: Age-Related Macular Degeneration

Summary: this project intends to collect participant somatic cells to prepare autologous induced pluripotent stem cell-derived retinal cells for future cell therapy of age-related macular degeneration patient.

one or more types of somatic cells will be collected from every participant by collecting approximately 100\~500 ml of midstream urine, 20\~30 ml of peripheral blood, skin biopsies (3mm), conjunctiva biopsies (5mm×5mm), etc. then, these somatic cells will be used to prepare patient autologous induced pluripotent stem cell-derived retinal cells for the cell therapy of age-related macular degeneration patient.

Eligibility criteria:
inclusion criteria: 1. aged 55-80 years; 2. clinical diagnosis is consistent with the definition of advanced age-related macular degeneration; 3. the bcva of the target eye will be lower than 20/200; 4. -8.00 d \< refraction \< +8.00 d, 21 mm \< anteroposterior axis≤ 28 mm; 5. voluntary as test subjects, informed consent, regular follow-up on time; 6. voluntary as test subjects to join the associated clinical research on autologous ipsc-derived retinal cell therapy for amd (ethical approval and informed consent documents will be applied and signed separately); exclusion criteria: 1. macular atrophy caused by other diseases in addition to amd; 2. malignant tumor and history of malignancy; 3. any immune deficiency; 4. lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, inherited retinal dystrophy, optic neuropathy, and other ocular histories; 5. other intraocular surgery histories besides cataract surgery; 6. severe heart failure or the left ventricular ejection fraction \<35% in the previous 6 months; 7. dialysis or egfr \<20ml/min/1.73m2; 8. urine protein/urine creatinine ratio ≥1g/g; 9. creatinine or albumin/urine creatinine ratio ≥600mg/g; 10. chronic liver disease with alt three times over the upper limit of normal value; 11. combined with severe systemic diseases, such as heart failure, liver disease, copd, etc. 12. combined with severe infectious diseases, such as hiv, hbv, hcv, syphilis, etc. 13. hcv-rna positive, hbv-dna \>103 iu/ml, or tb, etc., during the infectious period; 14. use anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days; 15. abnormal blood coagulation function or other laboratory tests; 16. use glucocorticoids, immunosuppressive drugs, or antipsychotic drugs in the previous 3 months; 17. use antipsychotic drugs in the previous 3 months, such as antidepressants drugs, antimanic drugs, etc. 18. allergy to tacrolimus or other macrolides; 19. a history of addiction to alcoholism or prohibited drugs; 20. be participating in other intervention clinical trials or receiving other study medications; 21. informed refusal； 22. some other situations which might increase the risks of the subjects or interfere with clinical trials, such as mental disorders, cognitive dysfunction, etc.
emotion regulation intervention to sustain physical activity in rural-dwelling women and men after myocardial infarction

Conditions: Cardiac Event; Emotions

Summary: the purpose of this study is to evaluate early preliminary efficacy of the emotion intervention in us adults who have experienced a first cardiac event and participating in phase ii cardiac rehabilitation. this study will evaluate early efficacy and evaluate the cognitive processes as intervention response variables. investigators will also examine the relationships between emotion regulation and other cognitive processes and symptoms (threat and stress, cognition and motivation), symptoms \[depression, anxiety, pain, sleep, and fatigue\]), and health related quality of life among adults enrolled in cardiac rehabilitation after a first cardiac event.

aim 1: evaluate early preliminary efficacy of the emotion intervention research hypothesis 1. compared with adults randomized to active healthy living attention control and usual care control groups, adults randomized to emotion will have greater improvement in these outcomes over time: 1.1. improved minutes of moderate to vigorous physical activity 1.2. symptom improvement (depression, anxiety, pain, sleep, and fatigue) 1.3. health related quality of life. aim 2: evaluate the cognitive processes as intervention response variables. research hypothesis 2. compared with adults randomized to active healthy living attention control and usual care control groups, adults randomized to emotion will have: 2.1. improved emotion regulation (efficiency and strategy use) 2.2. decreased perceived cardiac threat and general stress 2.3. improved cognition and motivation aim 3. exploratory. examine the relationships between emotion regulation and other cognitive processes and symptoms (threat and stress, cognition and motivation), and symptoms \[depression, anxiety, pain, sleep, and fatigue\]) among adults enrolled in cardiac rehabilitation after a first major cardiac event.

Eligibility criteria:
inclusion criteria: 1. first time major cardiac event as documented in medical record; 2. enrolled in cardiac rehabilitation phase ii program; 3. living independently; and 4. at least mild symptoms of depression and/or anxiety (determined by standardized measure cutpoints). exclusion criteria: 1. does not speak english; 2. major axis 1 psychiatric diagnosis (e.g. schizophrenia); 3. terminal cancer; and 4. legally blind

Keywords: emotion regulation
predictors of 30-day postoperative outcome after elective evar

Conditions: Postoperative Complications

Summary: this study investigated the 30-day postoperative outcome after elective evar and the role of possible predictors among patients' baseline characteristics

the study included 322 consecutive aaa patients treated electively with evar from march 2016 to february 2019 at a tertiary referral center. early follow-up with clinical and laboratory evaluation took place at the 30rd day post-operatively. any adverse event, such as major adverse cardiovascular events (mace), post-implantation syndrome (pis), acute kidney injury (aki), and deaths of any cause were recorded.

Eligibility criteria:
inclusion criteria: * only patients managed with evar using standard bifurcated devices in elective setting were included. exclusion criteria: * patients treated for ruptured, symptomatic, inflammatory or infectious aaa were excluded. furthermore, any patient needing complex endovascular repair of the proximal landing zone was considered ineligible. additional exclusion criteria were the presence of any trauma or surgery within two months before evar, any autoimmune or systemic inflammatory disease and any malignancy. of note, any patient with clinical or laboratory signs of infection before the scheduled operation was not offered an evar until a complete resolution of the infection was confirmed via a clinical, laboratory and/or imaging evaluation.
understanding visual processing after occipital stroke

Conditions: Vision Loss Partial; Vision; Loss, Both Eyes; Hemianopia, Homonymous; Hemianopia; Quadrantanopia; Stroke, Ischemic; Stroke - Occipital Infarction; Cortical Blindness; Occipital Lobe Infarct; Peripheral Visual Field Defect of Both Eyes

Summary: the purpose of this study is to investigate how visual orientation discrimination and metacognition (i.e., perceptual confidence) are affected by occipital stroke that causes hemianopia and quadrantanopia in adults. this research will provide insight as to how the residual visual system, which not directly damaged by the occipital stroke, processes orientation (assayed in terms of orientation discrimination) and metacognition (by measuring perceptual confidence for orientation discrimination). these measures will be used to refine computational models that attempt to explain how the brain copes with loss of primary visual cortex (v1) as a result of stroke. this knowledge is essential to devise more effective visual rehabilitation therapies for patients suffering from occipital strokes.


Eligibility criteria:
inclusion criteria: * residents of the united states or canada * mri and/or ct scans showing unilateral stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained 1-year or more prior to enrollment * reliable visual field defects in both eyes as measured by humphrey, macular integrity assessment (maia), goldmann, and/or equivalent perimetry. this deficit must be large enough to enclose a 5-deg diameter visual stimulus. * ability to fixate on visual targets reliably for 1000ms (as demonstrated by visual fields, and verified in study participation) * willing, able, and competent to provide informed consent * cognitively able to understand and respond to written and oral instructions in english exclusion criteria: * past or present ocular disease interfering with visual acuity * corrected vision worse than 20/40 in either eye * presence of damage to the dorsal lateral geniculate nucleus * diffuse, whole brain degenerative processes * brain damage deemed by study staff to potentially interfere with testing ability or outcome measures * documented history of traumatic brain injury * documented history of drug/alcohol abuse * current use neuroactive * cognitive or seizure disorders * subjects with one-sided attentional neglect

Keywords: occipital stroke vision loss after stroke vision recovery vision restoration partial vision loss vision loss
nasal iodine swab versus oral antibiotic to prevent surgical site infection after undergoing mohs micrographic surgery

Conditions: Skin Cancer; Skin Cancer Face; Malignant Cutaneous Adnexal Neoplasm

Summary: the purpose of this study is to compare surgical site infection rates for patients treated with mohs micrographic surgery after bilateral nasal swab with povidone iodine versus standard treatment including the use of a standardized oral antibiotic prophylaxis protocol.


Eligibility criteria:
inclusion criteria: * non-pregnant, non-lactating/breastfeeding, non-incarcerated, english-speaking persons undergoing mohs micrographic surgery (mms) for malignant cutaneous neoplasms and receiving same-day defect repair by the mms-performing surgeon * able to provide written informed consent prior to initiation of any study-specific procedures * able to swallow, retain, and absorb oral medications * all malignant cutaneous neoplasms will be included exclusion criteria: * on antibiotic treatment or established intolerance or contraindication to povidone-iodine * allergy to specific oral antibiotics that are utilized as part of the mayo clinic antibiotic prophylaxis protocol (cefalexin, azithromycin, clindamycin) * requiring oral antibiotic therapy for prophylaxis postoperative infectious endocarditis or hematogenous total joint infection * cases where skin reconstruction is performed with non-sterile gloves * patients with lesions on the legs, as dilute vinegar soaks are standard practice and this would be a confounder for preventing surgical site infection * patients at increased risk for severe infections, including patients on immunosuppressive medications and biologics, patients with a history of hiv infection, chronic lymphocytic leukemia, immunodeficiency syndromes, as well as patients with insulin-dependent diabetes mellitus
loaded breathing training in essential hypertension

Conditions: Essential Hypertension

Summary: the purpose of this study is to determine whether adding load to slow controlled breathing training could enhance blood pressure lowering in patients with essential hypertension.

hypertension (ht) is one of the major risk of cardiovascular diseases and cost of pharmacological treatment is a very high. lifestyle modification is the first trial in stage 1 hypertension before commencing pharmacological treatment and a co-treatment with drug in hypertensive patient. slow paced breathing training and physical training has been shown to reduce both systolic and diastolic blood pressure in ht. moreover loaded breathing was reported to be able to decrease blood pressure in healthy. loaded slow breathing training may enhance the antihypertensive effect of slow paced breathing.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of essential hypertension stage i-ii exclusion criteria: * respiratory disease * diabetes mellitus * heart disease * renal disease * cerebrovascular disease * dyslipidemia * pregnancy

Keywords: breathing exercise blood pressure hypertension
neutrino regimen for treatment-experienced hcv gt1 patients

Conditions: Chronic Hepatitis C Infection

Summary: this study will evaluate the efficacy and safety of neutrino regimen in chinese chronic hcv genotype 1b treatment-experienced patients.


Eligibility criteria:
inclusion criteria: 1. age equal to or greater than 18 years, with chronic genotype 1b infection; 2. hcv rna equal to or greater than 10,000 iu/ml at screening; 3. cirrhosis determination; 4. subjects who are treatment-experienced; 5. screening laboratory values within defined thresholds; 6. use of highly effective contraception methods if female of childbearing potential or sexually active male. exclusion criteria: 1. hiv or chronic hepatitis b virus (hbv) infection; 2. contraindications for peg or rbv therapy; 3. hematologic or biochemical parameters at screening outside the protocol-specified requirements; 4. active or recent history (≤ 1 year) of drug or alcohol abuse; 5. hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers); 6. chronic use of systemic immunosuppressive agents; 7. history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
sternal plating high risk

Conditions: Heart Diseases

Summary: participants are being invited to participate in a research study at university hospitals because they have heart disease and are scheduled for open heart surgery. currently, uh cardiac surgeons close the sternum (or breastbone) after a sternotomy (procedure that allows a doctor to reach the heart and blood vessels) with either a rigid plate fixation sternal plate or a wire cerclage. however, the study team would like to further evaluate these two techniques. any volunteer over the age of 18 who is at an increased risk for developing sternal wound complications may be eligible to participate.


Eligibility criteria:
preoperative inclusion criteria * adults (age range: 18-89) * undergoing cardiac surgery through sternotomy -≥2 risk factors: * diabetes mellitus * severe copd * chronic steroid use * immunosuppression * redo sternotomy * chronic * kidney disease with gfr \>30 ml/min per 1.73m2 * radiation therapy * bmi≥35 * high-risk of delirium * heavy alcohol use preoperative exclusion criteria * active malignancy * chronic narcotic use * nyha class iv * known nickel metal allergy * compliance concern * egfr\<30 ml/min per 1.73m2 * involvement in another interventional clinical trial (non-registry) * any criteria precluding rpf or wc operative inclusion criteria * off-midline sternotomy * bita grafting * cpb time ≥120 minutes * transverse sternal fracture operative exclusion criteria * emergent or emergent salvage surgery * non-standard sternotomies * sternotomy with bony margin \<2 mm * bleeding * delayed sternal closure * surgical complications * any criteria precluding rpf or wc

Keywords: cardiac surgery wound complication rigid sternal fixation sternal infection pain non-union
mesenchymal stem cells for treatment of poor graft function after allogeneic hematopoietic stem cell transplant

Conditions: Stem Cell Transplantation, Hematopoietic; Mesenchymal Stem Cells; Poor Graft Function; Hematological Diseases

Summary: the purpose of this study is to evaluate the utility of treating patients experiencing poor graft function after allogeneic hematopoietic stem cell transplantation with ex-vivo-expanded bm-drived mesenchymal stem cells from third-party donors. our first objective was to evaluate the effect of such treatment on poor graft function, and second object was to investigate the safety of such treatment.

allogeneic hematopoietic stem cell transplantation(allo-hsct) can cure many hematologic diseases. although good progress has been made in the prevention and treatment of side effects associated with transplantation, poor graft function (pgf) remains an important complication that occurs in 5-27% of patients, and is associated with considerable morbidity and mortality related to infections or hemorrhagic complications. treatment of pgf usually involves the prescription of hematopoietic growth factors such as granulocyte colony-stimulating factor (g-csf), or repeat transplantation, but these methods are associated with short-term effect and a significant risk of graft-versus-host disease（gvhd） development, respectively. mesenchymal stem cells (mscs) are a form of multipotent adult stem cells that can be isolated from bone marrow (bm), adipose tissue, and cord blood. clinical applications of human mscs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating graft-versus-host disease after allo-hsct and so on. however, the efficacy of treatment of pgf that develops after allo-hsct using expanded bm-derived mscs from a third-party donor is rarely reported. if such treatment could be shown to be effective and safe, bm-derived mscs could potentially be used as an universal donor material. this would have a major impact because the generation of donor-specific mscs is time-consuming, costly, and often impractical if the clinical status of a patient is urgent. in the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded bm-derived mscs from third-party donors in treating patients with pgf after allo-hsct.

Eligibility criteria:
inclusion criteria: * a patient age of 14-65 years * poor graft function developing after allo-hsct * subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)

Keywords: poor graft function mesenchymal stem cells allogeneic hematopoietic stem cell transplantation third-party donors
effects of behavioural activation on emotional cognition and mood

Conditions: Depression; Depressive Disorder; Mood Disorders; Cognition

Summary: behavioural activation (ba) is widely accepted as an efficacious treatment for depression. it has been suggested that several depression treatments work via early changes in emotional processing (e.g. affective bias in the processing of facial expressions) and that these could help predict treatment success, but it has not yet been examined whether the same applies in behavioural interventions. the investigators will examine how ba affects early emotional information processing in participants who are currently experiencing low mood, to see whether this can predict eventual changes in mood and to gain a better understanding of the treatment mechanisms of ba. participants will be in three groups undergoing either behavioural activation, or activity monitoring alone (active control) for 4 weeks, or they will be on a waiting list (passive control). the investigators will also examine whether other factors, such as anxiety, social support and environmental reward, can predict the success of ba. this could help us understand how ba works and who may be most suitable for this intervention.


Eligibility criteria:
inclusion criteria: * female or male * age: 18 to 65 years * competency to give informed consent * scores above 14 on bdi-2 (bottom criterion for mild depression) exclusion criteria: * previous participation in a study that used the emotional test battery (etb) * currently undergoing any form of psychotherapy or counselling * taking antidepressant medication for less than 3 months, or changing existing psychiatric medication within the past month * current or past a diagnosis of psychosis or a bipolar disorder * current diagnosis of an eating disorder, a borderline personality disorder, or a substance abuse disorder * any other factor that would indicate the participant isn't able to comply with the requirements of the study according to the opinion of the chief investigator (severe insomnia, chronic fatigue syndrome, neurological conditions impairing cognitive function etc.) * symptoms of depression are too severe (score 20 and above on the phq-9 questionnaire or according to the evaluation of study psychiatrist)

Keywords: behavioural activation