Kornimate/medical-research-clean huggingface dataset:
an innovative disease-net management model for non-communicable diseases (sidera^b)

Conditions: Parkinson Disease (PD); Chronic Heart Failure (CHF); Chronic Obstructive Pulmonary Disease (COPD)

Summary: the sidera\^b telerehabilitation system is enabled by a multi-domain, multi-device platform providing at home multi-component rehabilitation, targeting cardiovascular (chronic heart failure, chf), pulmonary (chronic obstructive pulmonary disease, copd) and neurodegenerative (parkinson disease, pd) chronic diseases. the rehabilitation program embeds engagement activities for patient and caregiver, to empower appropriation of the sidera\^b care routines and fuel their well-being resources. the multidisciplinary layering of sidera\^b is reflected in the validation protocol including a) clinical and well-being evaluation through a cross-over study confronting usual care with the sidera\^b activities; b) technological evaluation: health technology assessment for organizational, legal and equity impacts; c) economic evaluation: process mapping and budget impact analysis to define a sustainable reimbursement process for the innovative telerehabilitation pathway.


Eligibility criteria:
inclusion criteria: 1. agreement to participate, with the signature of the informed consent form. 2. availability of a caregiver/study partner, who agrees to support the participant through the sidera\^b program. 3. living in one's own home. 4. clinical diagnosis of chronic heart failure (chf) and 1. functional new york heart association (nyha) class ii and iii with an ejection fraction (ef) ≤ 40% 2. etiology of chf primitive or post-ischemic. 5. clinical diagnosis of chronic obstructive pulmonary disease (copd) and 1. copd diagnosis according to the american thoracic society (ats) and the european respiratory society (ers) criteria with fev1/fvc ratio \<70% 2. presence of airway limitation according to ats/ers and gold criteria. 6. clinical diagnosis of parkinson disease (pd) and 1. pd diagnosis according to the mds criteria (postuma et al., 2015) 2. staging between 1.5 and 3 on the hoehn \& yahr scale (goetz et al., 2004) 7. age between 18 and 85 years. exclusion criteria: 1. presence of comorbidities that may prevent you from undertaking a secure home program or determining clinical instability (i.e. severe orthopedic or severe cognitive deficits). 2. presence of risk conditions for safety under strain in patients with chf (i.e. severe symptomatic aortic stenosis, evidence of ischemia due to minimal/low-intensity efforts). 3. copd patients who do not need rehabilitation treatment (gold 1 / a class) or with severe copd (gold 4 / d class) 4. copd patients with overlap with other respiratory diseases or not in treatment or in the absence of good ventilatory compensation in the last 6 months 5. copd with global respiratory failure with paco2\> 55 mmhg 6. pd patients with other neurological pathologies or with severe psychiatric complications 7. pathological score to a screening test for cognitive impairment (montreal cognitive assessment test - moca test \<17.54; conti et al., 2015).
ptc guiding neoadjuvant treatment in breast cancer

Conditions: Pathological Conditions, Signs and Symptoms

Summary: patients with breast cancer meet criteria for enrollment are randomized into ptc group or control group. the neoadjuvant therapy regimens are guided by ptc test in the ptc group. the regimens in control group are included of (dd)ec-t for her2 negative subtype, tch(p) or ec-th(p) for her2 positive subtype. we compared the pcr rate between two groups as the primary endpoint.

1. before neoadjuvant therapy, all samples will be obtained by core needle biopsy for ptc drug sensitivity test. 2. after obtaining drug sensitivity results and confirming er/pr and her2 expression state, all recruited patients will be randomized into the ptc group or the routine treatment group, according to the method of random number table. 3. beijing cornerstone life science and technology co., ltd. is responsible for gene sequencing and ptc drug sensitivity test for biological samples. all samples for the study are clinical residuals and will be used in the study, store or destruction is unapplicable. 4. neoadjuvant therapy regimen in the ptc group is guided by ptc drug sensitivity results, and regimen in the routine treatment group is based on clinical guideline, such as (dd)ec-t for her2 negative breast cancer, and tch(p) or ec-th(p) for her2 positive breast cancer. all neoadjuvant therapy will be completed before operation if without pd. 5. according to postoperative pathological remission, pcr patients in two groups continued to complete adjuvant targeted therapy based on original treatment. for non-pcr patients in the ptc group, ptc drug sensitivity test will be done again to guide adjuvant therapy, for non-pcr patients in the routine treatment group, capecitabine for her2 negative breast cancer, and t-dm1 or h(p) will be selected. 6. all patients will be received radiotherapy or endocrine therapy if necessary.

Eligibility criteria:
inclusion criteria: 1. female between 18 to 70 years old. 2. patients diagnosed with invasive breast cancer by pathology. 3. clinical stage considered as t2-4n0-2m0 . 4. her2 overexpression by ihc or fish positive. 5. patients plan to accept neoadjuvant therapy or plan to accept adjuvant therapy after neoadjuvant therapy and surgery. exclusion criteria: 1. patients have already accepted any other anti-tumor treatment not included in our project. 2. patients with metastasis are not considered surgery therapy. 3. patients cannot accept chemotherapy or anti-her2 targeted therapy, because of severe cardiovascular diseases or other reasons

Keywords: patient-derived tumor-like cell clusters breast cancer neoadjuvant therapy pathologic complete response
efficacy of plaque removal of a novel brushing device

Conditions: Dental Plaque

Summary: the purpose of this research study is to compare how a novel, automated mouthpiece-based toothbrushing device removes dental plaque compared to a manual toothbrush.

plaque is one of the main etiological factors in dental decay and the principal etiological factor for periodontal diseases. although toothbrushes have greatly evolved, dexterity is still the key component to an efficient cleaning routine. the primary goal is to examine 60 participants to determine the efficacy of a new powered teeth cleaning device designed to bypass the variability of individual dexterity compared with manual toothbrushing. this is a single-blind, randomized controlled trial. sixty pediatric patients will be recruited for the study and randomized into treatment and control groups, subdivided into primary (20), mixed (20), and permanent dentition (20). participants will be asked to abstain from brushing, flossing, gum or mouthwash use for 24 hours prior to the study visit. plaque will be assessed using the turesky modification of the quigley-hein plaque index before and after a one-time brushing with the assigned study device. a soft tissue assessment will be conducted and intraoral photos taken pre- and post-brushing.

Eligibility criteria:
inclusion criteria: * between the ages of 5-17 * in good general health * fluent in english * parent or guardian willing and able to provide written informed consent * have 16 scorable teeth (non-crown/bridge/or full amalgams) * have had a dental cleaning and exam in the past 24 months exclusion criteria: * advanced periodontal disease or severe gum disease * mouth or teeth pain that prevents brushing in any areas * intraoral piercings (tongue or lip) that cannot be removed * non-controlled diabetes * any autoimmune or infectious disease or any medical condition that would delay wound healing * untreated visible cavities or untreated dental work * oral or gum surgery in the previous 2 months * take antibiotic premedication for dental procedures * undergoing or require extensive dental or orthodontic treatment * current smoker * generalized recession over 1mm

Keywords: gingivitis toothbrushing oral hygiene biofilm
sleep and circadian mechanisms of non-dipping blood pressure

Conditions: Hypertension; Cardiovascular Risk Factor

Summary: this study will be the first to distinguish the relative contributions of sleep, circadian and behavioral mechanisms to the non-dipping bp profile in black adults and will lay the groundwork for optimizing therapies dependent on mechanisms, such as targeting sleep, targeting circadian rhythmicity, or targeting behaviors, and raising the possibility that ideal therapy for hypertension (htn) may differ by race. this research will ultimately help to improve health and survival in black populations with htn.

by studying standardized behaviors and regulators of bp during sleep and behavioral stresses across all circadian phases, this protocol will allow us specifically to: 1. to determine if poor sleep, while controlling for circadian phase, contributes to the higher overall bp and reduced nocturnal drop in bp in blacks compared to whites. 2. to determine if reduced bp responses to standardized behavioral changes across the day and night contribute to the higher overall bp and reduced nocturnal drop in bp in blacks compared to whites. 3. to determine if reduced circadian amplitude of bp contributes to the higher overall bp and reduced nocturnal drop in bp in blacks compared to whites.

Eligibility criteria:
inclusion criteria: * self-identified black or white * 'normotensive' (resting systolic blood pressure (sbp) \<140/90 mmhg) or uncomplicated stage 1 'hypertensive' (systolic bp between 140 and 160 mmhg or a diastolic (dbp) between 90 and 100 mmhg). * free of all prescription and non-prescription drugs (including caffeine, nicotine, alcohol and herbal medications) exclusion criteria: * currently treated with pharmacologic agents for hypertension * blood pressure \>160/100 mmhg * smoked within the last year * regular night work or rotating shift work for the three months prior to the study * travel across more than three time zones during the three months prior to the study. * any acute, chronic or debilitating medical conditions, other than mild hypertension (140\<sbp\<160 or 90\<dbp\<100 mmhg) and severe renal disease (glomerular filtration rate \<30) * moderate to severe obstructive sleep apnea (osa) * history of severe psychiatric illnesses or psychiatric disorders will be excluded, including alcoholism, drug dependency, major depression, manic depressive illness, schizophrenic disorders, panic disorder, generalized anxiety disorder, post-traumatic stress disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder.

Keywords: circadian rhythm
a study to evaluate a new silicone hydrogel contact lens

Conditions: Myopia

Summary: the objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses.


Eligibility criteria:
inclusion criteria: * have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * be myopic and require lens correction from -0.50 d to -5.50 d in each eye. exclusion criteria: * any systemic disease affecting ocular health. * using any systemic or topical medications that will affect ocular physiology or lens performance. * an active ocular disease, any corneal infiltrative response or are using any ocular medications. * any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * allergic to any component in the study care products.

Keywords: contact lens
can parathyroid hormone injections reverse glucocorticoid-induced osteoporosis

Conditions: Osteoporosis

Summary: glucocorticoids are potent anti-inflammatory and immunosuppressive agents. however, prolonged use of these potent agents results in severe bone loss and osteoporotic fractures. parathyroid hormone (1-34), when given as a daily injection has been found to dramatically increase bone mass in osteoporotic animals and postmenopausal women. the purpose of this study is to determine whether 2 years of daily pth (1-34) injections will increase bone mass and reduce the development of new fractures. in addition, we will follow the study subjects for 2 more years to determine which type of anti-resorptive agent is required to maintain the newly formed bone. we are enrolling postmenopausal women that are on chronic corticosteroid therapy (prednisone etc.) and have bone loss (osteopenia by dxa) to be a part of this four-year-long study. the patients will receive two-year therapy with either pth (1-34) or placebo, and for the second part of the study subjects receive either estrogen and placebo or alendronate and placebo. we will measure bone gain by standard bone densitometry, special x-rays of the spine and hip, and serum and urine bone markers.


Eligibility criteria:
inclusion criteria: * postmenopausal women on glucocorticoids (prednisone 5mg/d or greater * osteopenia by t score of hip or lumbar spine of -2.0 * all study subjects must be on a stable dose of estrogen/progesterone or raloxifene * ambulatory and able to come to the clinical center 9 times over 2 years * willing to sign an informed consent exclusion criteria: * generalized disease of the bone (other than glucocorticoid-induced osteoporosis), including hyperparathyroidism, hyperthyroidism, paget's disease) * diseases that affect bone metabolism (e.g. alcoholism, inflammatory bowel disease, malabsorption, renal disease (cr2) or liver disease (transaminase level 2 times limit of normal) * within the past 1 year, regular use of medications that are known to affect bone metabolism (e.g. anabolic steroids, anticoagulants, anticonvulsants, pharmacologic doses of vitamin d and vitamin a supplements). * history of drug abuse * senile dementia, paraplegia and/or quadriplegia * unstable rheumatic disease with clinically significant renal or central nervous system involvement.

Keywords: parathyroid hormone (1-34) glucocorticoid-induced osteoporosis postmenopausal women osteoporotic fractures
the regulation of pulmonary vascular resistance in patients with heart failure

Conditions: Diastolic Heart Failure; Pulmonary Hypertension

Summary: peripheral blood and blood following a pulmonary wedge pressure will be obtained from patients undergoing right heart catheterizations.

it is well known that left sided heart disease can lead to pulmonary hypertension via a number of proposed mechanisms. the purpose in this study is to identify biomarkers in pulmonary hypertension to further understand the pathophysiology of this disease in patients with heart disease.patients are recruited in the cardiac catheterization lab, which are undergoing right heart catheterization as per their plan of care established by their primary cardiologist. during the procedure, we will ask the performing cardiologist to obtain a blood sample of 40-50 milliliters from the catheter that they are using during the procedure. these blood samples will be sent for analysis of biomarkers. the patient will then have an echocardiogram done 1 year from their heart catheterization.

Eligibility criteria:
inclusion criteria: * age \>18 years * ability to provide informed consent. * presenting for cardiac catheterization for evaluation of heart disease * ejection fraction \> 50% exclusion criteria: * unable to provide informed consent. * unable or unwilling to comply with the protocol and follow up. * infiltrative cardiomyopathy * constrictive pericarditis * severe valvular disease * comorbid status with life expectancy \<3 years * right ventricular dysplasia * congenital heart disease * on immunosuppressive drugs. * patients who has heart transplant. * ejection fraction \< 50% * mean pulmonary artery pressure \<25 * wedge pressure \<15
a study of roactemra/actemra (tocilizumab) versus adalimumab in combination with methotrexate (mtx) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one tumor necrosis factor (tnf)-inhibitor

Conditions: Rheumatoid Arthritis

Summary: this randomized, parallel-group study will assess the efficacy and safety of roactemra/actemra (tocilizumab) versus adalimumab, both in combination with methotrexate (mtx) in patients with moderate to severe active rheumatoid arthritis. patients, already treated with mtx at stable doses, will be randomized to receive either roactemra/actemra 8 mg/kg intravenously (iv) every 4 weeks or adalimumab 40 mg subcutaneous (sc) every 2 weeks. all patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly). the anticipated time on study treatment is 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * rheumatoid arthritis of \>/= 6 months duration (according to american college of rheumatology (acr) criteria)(according to acr criteria) * inadequate response due to inefficacy of treatment (for at least 3 months) with only one approved tumor necrosis factor (tnf)-agent other than adalimumab depending on the tnf-inhibitor, last dose of tnf-inhibitor should have been 1 to 8 weeks before randomization to the study * on methotrexate treatment for \>/=12 weeks immediately prior to baseline, with stable dose (10-25 mg/week) for the last 8 weeks * disease activity score (das28) \>3.2 at baseline * oral corticosteroids (\ /=6 weeks prior to baseline. exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization * rheumatic autoimmune disease other than rheumatoid arthritis * prior history of or current inflammatory joint disease other than rheumatoid arthritis * functional class iv (acr criteria) * history of severe allergic reaction to human, humanized or murine monoclonal antibodies * known active current or history of recurrent infection (including tuberculosis) * primary or secondary immunodeficiency (history of or currently active) * body weight \>150 kg * previous treatment with any cell-depleting therapies * previous treatment with tocilizumab * intra-articular or parenteral corticosteroids within 6 weeks prior to baseline.
combined peripheral (breestim) and central electrical stimulation (tdcs) for neuropathic pain management - spinal cord injury

Conditions: Pain Management

Summary: this study looks at the effect of combined breathing-controlled electrical stimulation (breestim) and transcranial direct current stimulation (tdcs) on neuropathic pain after spinal cord injury, amputation, or brain injury. the hypothesis is that a single session of combined breestim and tdcs will produce an additive analgesic effect. this record covers the study in a population of spinal cord injury patients. note that this study will also enroll healthy volunteers, brain injury patients, and amputation patients and that this study as applied to these other populations will be covered in separate clinicaltrials.gov records.


Eligibility criteria:
inclusion criteria: * between 18 and 75 years * male and female subjects * has neuropathic pain after traumatic spinal cord injury * has chronic pain, \>3 months * is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.) exclusion criteria: * currently adjusting oral pain medications for their neuropathic pain * have pain, but not neuropathic (e.g., from inflammation at the incision wound of the residual limb or neuroma) * have a pacemaker, or other metal and/or implanted devices * have amputation in their arm(s) * have spinal cord injury (sci) involving impairment of arms * have cognitive impairment from brain injury or are not able to follow commands, or to give consent * have asthma or other pulmonary disease * are not medically stable * have preexisting psychiatric disorders * alcohol or drug abuse * have a history of seizures/epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants. * mini-mental state examination (mmse), a brief 30-point questionnaire test that is commonly used in the literature, will be used to screen for cognitive impairment. a brain injury patient with a score of 24 or lower on mmse will be excluded.
reengineering methadone treatment study of patient-centered methadone treatment

Conditions: Opiate Dependence

Summary: the purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and hiv-risk behavior as compared to methadone treatment as usual.

early drop-out and premature discharge from methadone treatment is common in the united states and may be associated with drug use and its associated problems. the purpose of this study is to evaluate the effectiveness of a novel approach to the organization methadone treatment in which the patient rules and staff roles of the clinic will be modified for study participants as compared to patients receiving standard methadone treatment.

Eligibility criteria:
inclusion criteria: * opiate dependence * newly admitted to methadone treatment exclusion criteria: * pregnancy

Keywords: methadone treatment opiate dependence services research
spyglass+rfa versus cytobrush+rfa for extrahepatic cholangiocarcinoma

Conditions: Extrahepatic Cholangiocarcinoma; Malignant Biliary Obstruction

Summary: with the development of endoscopic technology, endoscopic retrograde cholangiopancreatography (ercp) has been widely used in the diagnosis and treatment of extrahepatic cholangiocarcinoma.in patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ercp had a lower pathologically positive rate and increased the times of ercps, increased the risk of postoperative complications at the same time.the present study aims to compare the efficacy and safety outcomes of spyglass+rfa versus cytobrush+rfa for extrahepatic cholangiocarcinoma.

endoscopic retrograde cholangiopancreatography (ercp) has been used as the primary method for the diagnosis of biliary strictures and the treatment of extrahepatic cholangiocarcinoma. however, the accurate visual diagnosis of malignant biliary strictures and assessment of the extent of a lesion are not possible by ercp, and treatment of extrahepatic cholangiocarcinoma by ercp procedures is sometimes difficult. in patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ercp had a lower pathologically positive rate and increased the times of ercps, increased the risk of postoperative complications at the same time. spyglass enables direct visualization of the biliary tract and the sampling of suspicious lesions, together with radiofrequency ablation.endoscopic radiofrequency ablation (rfa) is an emerging technique for the palliation of inoperable malignant biliary strictures (mbss). in a dozen published studies, this novel approach has shown better safety and feasibility, as well as improvement in overall survival (os). the present study aims to compare the efficacy and safety outcomes of spyglass+rfa versus cytobrush+rfa for extrahepatic cholangiocarcinoma.

Eligibility criteria:
inclusion criteria: * age \>18 years ; * patients with high suspicion of extrahepatic cholangiocarcinoma such as unexplained bile duct stenosis or elevated ca19-9 were found according to relevant imaging studies or symptoms; * willing to abide by the research procedures and sign the informed consent. exclusion criteria: * myocardial infarction within 3 months; * renal insufficiency (scr\>177 umol/l); * serious cardiovascular and cerebrovascular or respiratory diseases before surgery; * preoperative shock manifestations, such as hypotension ( systolic blood pressure \ 120 beats/min); * pregnancy and lactation; * allergic to nsaids; other clinical observation trials or those who have participated in other clinical trials within 60 days; * cases deemed inappropriate by the investigator (such as those with clear contraindications to ercp).

Keywords: spyglass rfa extrahepatic cholangiocarcinoma ercp