Kornimate/medical-research-clean huggingface dataset:
cognitive training with and without tdcs to improve cognition in hiv

Conditions: HIV; Mild Neurocognitive Disorder

Summary: the purpose of this study is to develop pilot data on the potential efficacy of computer-based cognitive training or the combination of computer-based cognitive training with transcranial direct current stimulation (tdcs) in improving cognitive function in persons with hiv-related mild neurocognitive disorder (mnd).

the purpose of this study is to develop pilot data on the potential efficacy of computer-based cognitive training or the combination of computer-based cognitive training with transcranial direct current stimulation (tdcs) in improving cognitive function in persons with hiv-related mild neurocognitive disorder (mnd). tdcs is a noninvasive brain stimulation technique in which a small direct current (1-2 ma) is applied to the scalp during a cognitive or motor activity, inducing a very small current that affects specific neural circuits related to the site at which electrodes are placed. tdcs has been judged safe and has shown significant treatment effects in studies with other populations, but has not been extensively studied in individuals with hiv infection. tdcs has been shown to facilitate learning in a number of studies, suggesting that it may improve or enhance learning in those with cognitive problems. as hiv infection is associated with decrements in a number of cognitive skills, including working memory, executive functions, and psychomotor speed that are related to individuals' functional status and medication adherence, the demonstration of a technique to enhance the effects of cognitive training in this population would have substantial clinical benefits as well as scientific value.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * fluent in english * meets frascati criteria for mild neurocognitive disorder exclusion criteria: * left handed * presence of dementia * use of specific psychotropic medications including antidepressants, antipsychotics, and sleep-promoting medications
availability of poor quality embryos

Conditions: Infertility

Summary: the purpose of this study is to explore a method to identify the viability of day-3 poor quality embryos

day-3 poor quality embryos are related to significant lower clinical pregnancy,so freezing numerous poor quality embryos are clinical impractical. to ensure the successful pregnancy and to enhance the availability of the poor quality embryos, day-3 poor quality embryos are further cultured to different developmental stage and then cryopreserved. the viability of these embryos are tested in frozen-thawed transfer.

Eligibility criteria:
inclusion criteria: * unfertile women exclusion criteria: * women older than 40 years

Keywords: day-3 poor quality embryo vitrification clinical outcome
functional and non-functional csf shunt flow measured with a second-generation wireless thermal device

Conditions: Hydrocephalus

Summary: this study compares the performance of two generations of non-invasive cerebrospinal fluid (csf) shunt flow assessment devices. measurements of known non-functional and functional implanted shunts will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.


Eligibility criteria:
inclusion criteria: 1. at least one existing ventricular csf shunt, functional or non-functional (including an adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device 2. if more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region 3. signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 4. signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes) 5. verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision exclusion criteria: 1. presence of an interfering open wound or edema in the flowsense device measurement area 2. patient-reported history of adverse skin reactions to adhesives 3. previous participation in a rhaeos clinical study in which flowsense device measurement data were acquired 4. new or worsening symptoms of a possible shunt malfunction in the prior 7 days 5. use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject 6. participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
clinical evaluation of alvimopan (sb767905) on constipation and related symptoms associated with opioid

Conditions: Cancer; Constipation

Summary: this study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, od), 0.5mg/day (0.25mg, bid) or 1mg/day (0.5mg, bid) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group. also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.


Eligibility criteria:
inclusion criteria: * have cancer. * taking opioid therapy for continued intractable pain. * experiencing less bowel movement frequency compared to that before the opioid treatment. * must meet the protocol-definition of opioid-induced constipation. exclusion criteria: * gastrointestinal or pelvic disorders known to affect gastrointestinal functions or induce bowel transit disorder and ileus. * subjects, who in the investigator's opinion, have gastrointestinal dysfunction predominantly due to causes other than the use of opioids.

Keywords: opioids cancer constipation
psoriatic arthritis and psoriasis treatment decision aid

Conditions: Psoriatic Arthritis; Psoriasis

Summary: the purpose of this study is to create and test a patient decision aid that facilitates the shared decision-making process when patients with psoriasis and/or psoriatic arthritis are starting or switching to a new therapy.

prior to the interventional study, we will develop a decision aid using design thinking. in this interventional study, we will implement and test a patient-centered decision aid for therapy selection among patients with psoriasis and/or psoriatic arthritis who are starting or switching to a new medication.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. diagnosis of psoriasis (as confirmed by dermatologist) or psoriatic arthritis (as confirmed by rheumatologist) 3. treated at penn in addition to the above, for the observation and implementation phases of the study: 4. initiation of a new psoriasis or psoriatic arthritis treatment * biosimilars that have been approved by the fda and available on the us market will similarly be eligible for participation * patients may be taking other traditional dmards. * a washout period is not required. exclusion criteria: 1. unable to give informed consent 2. youth, under the age of 18 years 3. patients without psoriasis or psoriatic arthritis 4. not being treated at a penn clinic in addition to the above, for the observation and implementation phases of the study: 5. not starting or switching to a new medication

Keywords: decision aid shared decision-making
new approaches to inoca

Conditions: New Approaches in INOCA

Summary: ischemia with non-obstructive coronary arteries (inoca) is common in patients with angina. inoca has been associated with an increased risk of death, myocardial infarction, and stroke, particularly in symptomatic subjects. previous investigations have evidenced the key role of poor glycemic control and diabetes in coronary microvascular dysfunction. metformin is an old oral antidiabetic drug which is currently used to achieve glycemic control.

ischemia with non-obstructive coronary arteries (inoca) is common in patients with angina. inoca has been associated with an increased risk of death, myocardial infarction, and stroke, particularly in symptomatic subjects. coronary microvascular dysfunction, triggering structural remodeling and vasomotor disorders of coronary arterioles, is currently one of the leading hypotheses to explain inoca pathophysiology. previous investigations have evidenced the key role of poor glycemic control and diabetes in coronary microvascular dysfunction. metformin is an old oral antidiabetic drug which is currently used to achieve glycemic control. also, previous reports evidenced that metformin improves endothelial dysfunction. nowadays, it is used in prediabetic patients too. in this scenario, we evaluated the role of metformin in reducing the risk of re-hospitalization in inoca.

Eligibility criteria:
inclusion criteria: * age ≥18 years; * diagnosis of inoca; * availability to participate in the study exclusion criteria: * cancer; * atrial fibrillation or left bundle branch block; * previous acute coronary syndrome (acs) or cardiac revascularization; -pregnancy; * severe heart valve disease

Keywords: inoca hyperglycemia metformin endothelial dysfunction pci
stress-reducing intervention in patients with colorectal and breast cancer

Conditions: Breast Cancer; Colon Cancer

Summary: the goal of this interventional study is to test the heart-rate variability biofeedback intervention (hrv bi) in 2 cohorts of patients. cohort a will evaluate the effect of the addition of hrv bi in patients with breast cancer treated in the neoadjuvant setting (vs. standard of care alone, soc) followed by local therapy (surgery +/-radiotherapy). cohort b will evaluate the effect of the addition of hrv bi in patients with colon cancer after surgery in the adjuvant setting (vs. standard of care alone, soc).

this is a prospective, interventional, clinical study with in 2 cohorts. target of subjects is 50 per cohort and an anticipated total duration of 36 months. participants will undergo 4 sessions of hrv bi with the trainer where they will learn about the prognostic role of the vagal nerve in cancer and in reducing distress and pain, and how to perform deep paced breathing with the hrv monitoring. they will perform the training daily (3-times, minimum 7 minutes each) at home with the online control for 3 months. researchers will compare the effect of addition of 3-months training of hrv bi to soc on inflammation, hrv, quality of life (qol), cognitive functions, salivary cortisol slopes, sleep quality and treatment outcomes of patients with colorectal and breast cancer.

Eligibility criteria:
inclusion criteria: 1. patients older than 18 years. 2. pathologically confirmed breast cancer indicated for neoadjuvant systemic treatment or colon cancer after curative surgery indicated for adjuvant systemic treatment. 3. adequate renal functions: measured or calculated (by cockcroft formula) creatinine clearance \> 60 ml/min. 4. absolute granulocytes count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5x the upper limit of normal value. 5. adequate liver functions defined by ast (aspartate aminotransferase) and alt (alanine transaminase) ≤ 3xunl (upper normal of limit). 6. basic computer skills of patient or his family member. 7. signed informed consent. exclusion criteria: 1. previous chemotherapy. 2. previous malignancy, except for basal-cell carcinoma of the skin within last 5 years. 3. patients with know primary immunodeficiency and patients infected by the human immunodeficiency virus (hiv). 4. patient receiving long term corticosteroid treatment, anti-arrhythmic drugs and opioids who can not withdraw the treatment for the period of application of the heart rate variability (hrv) biofeedback training. 5. patients with diabetes mellitus, cardiac arrhythmia, cardiac pacemaker implant. 6. patients who do not fit inclusion criteria.

Keywords: colon cancer invasive breast cancer neoadjuvant chemotherapy standard of care inflammation stress telemedicine circadian rhythms sleep quality quality of life autonomic nervous system heart-rate variability
a study to evaluate the neovista ophthalmic system for the treatment of subfoveal cnv in patients with amd that have failed primary anti-vegf therapy

Conditions: Wet Age-related Macular Degeneration

Summary: the objective of this clinical study is to evaluate the safety and feasibility of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (cnv) in patients with age related macular degeneration that have failed primary anti-vegf therapy.

therapeutic advances in the arena of neovascular age-related macular degeneration (amd) have provided multiple treatment options for the disease. radiotherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. treatment with radiotherapy and anti-vegf compounds is a promising approach to treating amd.

Eligibility criteria:
inclusion criteria: * subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the investigator, secondary to amd, with a total lesion size (including blood, scarring, and neovascularization) of \< 12 total disc areas (21.24 mm2), and a gld ≤5.4 mm * subjects must have received a minimum of three (3) prior injections (a minimum of 3 prior injections of the same compound) of anti-vegf therapy (lucentis® or avastin®, subjects may have been treated previously with macugen®, but must have been most recently treated with lucentis® or avastin® and met the criteria for failure below) with evidence of "failure" to respond to therapy * subjects must be age 50 or older exclusion criteria: * subjects with prior or subfoveal cnv therapy with photodynamic therapy, intravitreal or subretinal steroids, or transpupillary thermotherapy (ttt) (note: this includes subjects with no known history, but with photographic evidence of prior therapy) * subjects who underwent previous radiation therapy to the eye, head or neck * subjects who have been previously diagnosed with type 1 or type 2 diabetes mellitus. subjects who do not have a documented diagnosis but have retinal findings consistent with type 1 or type 2 diabetes mellitus. * women of child-bearing potential (female subjects must be post menopausal or surgically sterilized)

Keywords: macular degeneration amd wet age-related macular degeneration
development of prosocial behaviors and related brain network in infants of high and low risk of asd

Conditions: Autism or Autistic Traits; Healthy

Summary: the goal of this observational study is to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (asd). the main questions it aims to answer are what the differences in prosocial behaviors and related brain network connections between infants/toddlers at high and low risk of asd are. participants will receive developmental and social communicational assessments (griffiths mental developmental scales, peabody developmental motor scales, the communication and symbolic behavior scales developmental profile infant-toddler checklist), resting-state eeg and mri in a natural sleeping state.

the longitude observational study will be performed to compare the developmental trajectories of prosocial behaviors and functional network connections in infants and toddlers at high and low risk of autism spectrum disorder (asd). we will follow up the subjects at 3-, 6-, 9-, 12-, 18-, 24-, 30-, and 36-month-old. clinical diagnosis will be made on 24-month-old or after, with the dsm-5 as the diagnostic criterion.

Eligibility criteria:
inclusion criteria: * subjects were enrolled as high-risk if they had an older sibling with a clinical diagnosis of asd confirmed on the autism diagnostic observation schedule, second edition (ados-2) or autism diagnostic interview (adi-r). * subjects were enrolled in the low-risk group if they had an older sibling without evidence of asd and no family history of a first or second-degree relative with asd. exclusion criteria: 1. diagnosis or physical signs strongly suggestive of a genetic condition or syndrome (e.g., fragile x syndrome) reported to be associated with asds; 2. a significant medical or neurological condition affecting growth, development or cognition (e.g., cns infection, seizure disorder, congenital heart disease); 3. sensory impairment such as vision or hearing loss; 4. low birth weight (\<2000 grams) or prematurity (\<37 weeks gestation); 5. possible perinatal brain injury from exposure to in-utero exogenous compounds reported to likely affect the brain adversely in at least some individuals (e.g., alcohol, selected prescription medications); 6. contraindication for mri (e.g., metal implants); 7. a family history of intellectual disability, psychosis, schizophrenia or bipolar disorder in a first-degree relative.
clinical trail of transcranial mr-guided focused ultrasound in the treatment of motor symptoms in patients with parkinson' disease

Conditions: Parkinson Disease, Idiopathic

Summary: randomized, double-blind, self-cross-over control (after the first visit, patients are divided into two groups, randomly receiving real stimulation/placebo stimulation. 10 days later, during the second visit, a cross-over occurs: patients who received real stimulation in the first visit will receive placebo stimulation in the second visit, and vice versa. the grouping situation remains blinded for the patients, tms analysts, and video analysts.)


Eligibility criteria:
inclusion criteria: * meets the clinical probable parkinson's disease diagnostic criteria proposed by mds-updrs; * disease duration of 4 years or less; * unmedicated or has been off medication for more than 12 hours, with h\&y stage ≤ 2. exclusion criteria: * history of stroke or seizures, dementia; previous surgical interventions for parkinson's disease; contraindications for tms (such as cardiac pacemakers, transcranial implants, and metal implants); severe mental disorders such as depression or psychosis; inability to understand the study procedures; use of antipsychotic medications; pregnancy.
predictors of recovery and the app-facilitated tele-rehabilitation (after) program for covid-19 survivors

Conditions: Covid-19; Deconditioning

Summary: the aim of this study is to investigate the feasibility (safety, adherence) and initial efficacy (physical function and patient reported outcomes) of a multicomponent tele-rehabilitation program during covid-19 recovery of patients who have been hospitalized due to covid-19.

the aim of this study is to investigate the feasibility and initial efficacy of a multicomponent tele-rehabilitation program during covid-19 recovery. the tele-rehabilitation program will include biobehavioral training and high intensity exercise facilitated through an online application ('platform'). initial efficacy will be assessed primarily by performance on the 30" chair stand test and secondarily through other physical function tests and patient reported outcome measures. this study will advance the feasibility of tele-rehabilitation as a more generally useful intervention in patients lacking access (distance, availability, mobility) to standard rehabilitative services and could transform the way in which acute rehabilitation and post-hospital care is delivered for all patients.

Eligibility criteria:
inclusion criteria: 1. confirmed covid-19, per diagnostic criteria (pcr testing) 2. hospitalized for at least 24 hours 3. able to provide informed consent 4. internet capability to access the platform 5. community-dwelling prior to hospitalization exclusion criteria: 1. unstable medical comorbidities that would preclude participation in exercise 2. receipt of \>1 session of outpatient physical therapy 3. known pregnancy, as the impact on physical function, pulmonary function, and other outcomes will vary well beyond any expected effects of covid-19 4. anticipating concurrent additional physical therapy services during study intervention period (12 weeks)

Keywords: tele-rehabilitation high intensity biobehavioral activity self-monitoring physical functional performance
the efficacy and safety of ornithine aspartic acid granules in nafld against silymarin capsules

Conditions: Non-alcoholic Fatty Liver Disease

Summary: this is a multicenter, randomized, double-blind, double-dummy, and positive control clinic trial which explores the efficacy and safety of ornithine aspartate granules in the treatment of non-alcoholic fatty liver disease against silymarin capsules. the hypothesis is that the ornithine aspartate granules have similar or better efficacy than the silymarin capsules.


Eligibility criteria:
inclusion criteria: * 1. consistent with nafld diagnosis criteria, and during previous one month, the b-mode ultrasonography showed diffuse fatty liver and fibroscan test showed that cap value \> 248 db/m; * 2. during previous one month, serum alt level was higher than 1.5 times the upper limit of normal. * 3. bmi is not more than 30 kg/m2. * 4. voluntary to participate in the research and signed a written informed consent to comply with the trial protocol. exclusion criteria: * 1. hereditary metabolic or autoimmune liver disease, hepatotropic and non-hepatotropic virus infection, drug/toxic/alcoholic/biliary liver injury, or any end-stage liver disease; fatty liver disease caused by one of the following reasons: total parenteral nutrition, inflammatory bowel disease, hypothyroidism, cushing's syndrome, beta-lipoprotein deficiency and some insulin resistance (ir) related syndromes (lipid atrophic diabetes, mauriac syndrome); * 2. hepatic or extrahepatic malignant tumors; * 3. severe heart failure or renal failure (serum creatinine \> 3mg/100ml); * 4. allergic constitution, or allergic to amino acid drugs or to ornithine aspartate and its constituents or to silymarin; * 5. alt or γ-glutamyl transpeptidase (γ-gt) are greater than 5 times the upper limit of normal, or total bilirubin (tbil) \> 51 umol/l.; * 6. confirmed liver cirrhosis or fibroscan test showed e value \> 12.5 kilopascal (kpa); * 7. triglyceride \> 5.6mmol/l; * 8. diabetes diagnosed for more than 5 years, combined with current insulin therapy or taking hypoglycemic drugs with poorly controlled condition (hba1c \> 9%). * 9. women who are pregnant, nursing or preparing for pregnancy; * 10. suspected or confirmed excessive drinking (equivalent alcohol amount: male, \> 40g/d; female, \> 20g/d), or history of drug abuse; * 11. combined use of drugs with liver protection and anti-inflammatory effects, as well as any chinese patent medicine, chinese herbal medicine, or health products that may have liver protection or liver damage effects; * 12. taking weight-loss drugs or receiving weight-loss treatment; * 13. situations of inappropriate participation judged by researchers.