Kornimate/medical-research-clean huggingface dataset:
effect of a humanoid robot with virtual reality games to train arm function in children with cerebral palsy - thrive trial

Conditions: Cerebral Palsy (CP)

Summary: about 60% of children with cerebral palsy (cp) have impaired arm function. improving arm function requires hundreds of repetitions per day, which is impossible in a single clinical visit. thus, therapeutic exercises should be sustained in the home environment; however, the compliance in performing home exercise is low due to poor motivation, boredom, and forgetfulness. a better home program is needed. the objective of this project is to examine the effect of our developed "thrive" system (therapeutic humanoid robot in virtual environment: the combination of robot with virtual reality games), which can provide a motivating and tailored upper-extremity intervention program with instant feedback, to improve arm function in children with cp at their home. the investigators believe the newly developed "thrive" system can increase children's engagement and motivation in home exercises as the robot is their playmate to demonstrate and correct their movements. the investigators will also interview parents and children with cp to understand their impression of using technology at home to shape the intervention. the expected outcome is that children with cp receiving "thrive" will improve their arm function more and have better engagement than those who receive vr alone immediately after intervention and at follow-up. the long-term goal is to have the "thrive" system be the optimal home exercise platform as it can provide challenging but motivating exercises to improve children's arm function while assisting parents in supervising their children with cp to complete home exercises.


Eligibility criteria:
inclusion criteria: 1. participants are between the ages of 5 and 21 years; 2. diagnosed with spastic cp; 3. have a manual ability classification system (macs) level i-iii; 4. able to sit with trunk supported; 5. are able to reach forward for more than half of their arm length; 6. are able to comprehend and complete a three-steps commands; 7. are able to see a tv screen (with or without corrected vision); and 8. their primary caregiver is willing to follow the desired intervention dosing and all evaluation measurements. exclusion criteria: 1. they have received surgery or botulinum toxin type a injection in the training arm within the preceding 4 months or are scheduled to receive it during the planned intervention period, or 2. if they have a severe attention deficit or uncontrolled epilepsy, which may possibly be triggered by the light or sound of the video games.

Keywords: cerebral palsy virtual reality humanoid robot home-based intervention arm function
investigation to the mechanism of the neuroplastic modulation in central auditory tract

Conditions: Tinnitus; Neuromodulation; Electroacupuncture; Cochlear Diseases; Therapy

Summary: tinnitus is the awareness of sound or noise in the absence of acoustic stimulation. no definite therapeutic strategy of tinnitus has been developed yet. the current theory of tinnitus is the plasticity theory of neurophysiology model. although acupuncture has its role in tinnitus treatment, its actual role still remains to be elucidated. acupuncture has been proposed to induce the development of neuroplasticity. the aim of this project is to undergo a comprehensive investigation to the central auditory effect and the therapeutic effects of acupuncture in tinnitus. according the results of the preliminary studies, the objective auditory measurement and subjective tinnitus perception will be analyzed in tinnitus patients before and after acupuncture.

hearing loss is a common sensory deficit in human beings. besides communication handicaps, hearing loss may associate with niggling tinnitus symptoms. tinnitus is the awareness of sound or noise in the absence of acoustic stimulation. tinnitus may cause bothersome problems in cognition, mood, or psychosocial behaviour and constitute a significant portion in the outpatient clinics of ent practice. no definite therapeutic strategy of tinnitus has been developed yet. the current theory of tinnitus is the plasticity theory of neurophysiology model. according to this theory, several neuromodulation methods have been proposed such as repetitive transcranial magnetic stimulation (rtms) or vagus nerve stimulation (vns). although acupuncture has its role in tinnitus treatment, its actual role still remains to be elucidated. acupuncture has been proposed to induce the development of neuroplasticity. there are still few thorough researches to investigate the neurophysiological events after acupuncture. the aim of this project is to undergo a comprehensive investigation to the central auditory effect and the therapeutic effects of acupuncture in tinnitus. according the results of the preliminary studies, the objective auditory measurement and subjective tinn itus perception will be analyzed in tinnitus patients before and after acupuncture. the ultimate results of this project will clarify the basic central auditory effects of acupuncture and provide a potential for translational application of acupuncture to treat the common tinnitus patients.

Eligibility criteria:
inclusion criteria: * 18-30 y/o * normal hearing * no acupuncture contraindication exclusion criteria: * heart disease or other acupuncture contraindication * bleeding tendency * autoimmune disease * drug abuse * pregnant or breast-feeding * hearing loss * active otitis media or inner ear diseases or retro-cochlear pathology * incomplete treatment
an open-label study to assess the long-term safety of axs-05 in subjects with dementia of the alzheimer's type, advance-2 and accord-2 extension study

Conditions: Agitation in Patients With Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation, Psychomotor

Summary: the primary objective of this open-label extension trial is to evaluate the long-term safety of axs-05 for the treatment of alzheimer's disease agitation in subjects that participated in advance-2 and accord-2.

this is a multi-center, open-label extension trial to evaluate the long-term safety of axs-05 in subjects with alzheimer's disease (ad) agitation that wish to continue to receive axs-05 given completion of advance-2 (axs-05-ad-304) and accord-2 (axs-05-ad-303).

Eligibility criteria:
inclusion criteria: * completed the treatment period in study axs-05-ad-304 or exited from study axs-05-ad-303 due to study completion. * caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment. exclusion criteria: * caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions. * subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone. * any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being. * initiation of a new medication since enrolling in axs-05-ad-304 and/or axs-05-ad-303 which may pose a safety risk when taken concurrently with axs-05.

Keywords: ad agitation axs-05 nmda receptor antagonist dextromethorphan bupropion axsome
evaluation of a handwashing promotion program in three countries

Conditions: Infectious Disease; Respiratory Illness; Absenteeism

Summary: the purpose of this study is to assess whether simple, school-based handwashing promotion impacts health and hygiene knowledge among students and their families.


Eligibility criteria:
inclusion criteria: * 19 students per first grade class * piped water tap available to every 30 first grade students for handwashing exclusion criteria: * compulsory handwashing or distribution of hand wipes before school lunch * commercial handwashing promotion at school during previous 5 years

Keywords: schools handwashing prevention and control communicable diseases absenteeism
vitamin d and calcium supplementation in breast cancer

Conditions: Breast Cancer

Summary: this study aims at assessing the vitamin dstatus in breast cancer patients who receive letrozole for more than two months and to evaluate effects of vitamin d3 and calcium supplementation on arthalgia caused by letrozole on these patients.

background: vitamin d deficiency (\ 6 months and to evaluate the effects of vitamin d3 and calcium supplementation on them. methods: forty breast cancer patients were included. they were divided into 2 equal groups: control group received letrozole only, and vitd/ca group received letrozole in addition to 2000 iu vitamin d3 and 1000 mg of calcium per day for 12 weeks. baseline serum 25-hydroxy vitamin d concentrations were assayed and standard health assessment questionnaire was completed to assess the disability caused by musculoskeletal symptoms.

Eligibility criteria:
inclusion criteria: * newly diagnosed breast cancer patients. * postmenopausal hormone receptor positive. * patients receiving letrozole for more than two months * gender: female. * age: ≥ 50 years old. exclusion criteria: * patients with bone metastasis. * history of renal stones. * serum calcium \>11mg/l. * patients with renal insufficiency. * patients taking steroid hormone replacement therapy. * second malignancy.
analysis of brain tumors using matrix assisted laser desorption/ionization mass spectrometry

Conditions: Brain Diseases

Summary: we are collecting brain tissue specimens and blood samples from patients at vanderbilt university medical center who are undergoing intracranial surgery to remove brain tissue, including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery for other non-cancerous types of brain tissus. these specimens will then be studied using a novel microscopic laser-directed protein mass spectrometric analysis, looking for unique protein signatures.

we are collecting brain tissue specimens and blood samples from patients at vanderbilt university medical center who are undergoing intracranial surgery to remove brain tissue, including brain tumors, tissue from epilepsy surgery and brain tissue removed during surgery for other non-cancerous types of brain tissus. these specimens will then be studied using a novel microscopic laser-directed protein mass spectrometric analysis. data from different brain tissues including tumors of different histological sub-types will be analyzed for unique protein signatures. these protein signatures will then be statistically correlated with clinical data including time to tumor progression and response to therapy. the goal of this study is to determine molecular patterns that will be more predictive of tumor behavior, thus leading to an improved understanding of the basic biology of these poorly understood cancers. this in turn, may lead to more refined therapies and improved outcomes.

Eligibility criteria:
inclusion criteria: * a diagnosis of brain tumor or other non-cancerous tissue and are considered candidates fro a surgical procedure to biopsy or remove the brain tumor or other tissue type at vanderbilt university medical center. * age 2 to 85 exclusion criteria: * patient or guardian that is unable to understand the informed consent process.
expanded indications in the adult cochlear implant population

Conditions: Hearing Loss, Sensorineural

Summary: the purpose of this investigation is to expand fda-approved labeling for med-el cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.

fifty (50) subjects, 18 years of age and older, will be implanted across the united states and canada. subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with the med-el synchrony/synchrony pin cochlear implant system. . limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. subjects will be followed for twelve (12) months post-activation of the sonneteas audio processor.

Eligibility criteria:
inclusion criteria: * adults, 18 years of age or older at the time of implantation * moderate to profound hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies, bilaterally as defined by: low-frequency pta (250, 500, and 1000 hz) greater than 40 db high-frequencies not better than 65 db (3000 hz - 8000 hz) * sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10db * limited benefit from appropriately fit hearing aids, defined by cnc word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear * cnc word score in quiet of greater than or equal to 10% in the ear to be implanted * evidence of appropriately fit hearing aids as determined by the audiologist * bilateral hearing aids should be considered standard of care, except in situations where the audiologist, physician, or potential subject determines that unilateral fit is optimal * hearing aid fit should be verified through accepted measures such as functional gain or real-ear verification * if appropriately fit hearing aids have not been worn within the last year, a 30-day hearing aid trial must be completed prior to enrollment in the study * fluent in english * no radiological contraindications * ability to undergo general anesthesia * appropriate motivation and expectation levels * stated willingness to comply with all study procedures for the duration of the study exclusion criteria: * evidence that hearing loss is retrocochlear in origin * active middle ear infection * skin or scalp condition precluding use of external audio processor- suspected cognitive impairment or organic brain dysfunction * history of prior use of a hearing implant
exposure of nicu patients to pvc plasticizers in at-risk clinical situation: biomonitoring study from urinary samples

Conditions: Neonates or Premature Babies; Patient With Urinary Catheter; Patient Hospitalized in NICU

Summary: in response to restrictions related to the use of dehp as a plasticizer for pvc medical devices (mds), manufacturers have resorted to alternative plasticizers. these are now integrated into many mds such as infusion sets, extension lines, extracorporeal circuits, nutrition tubings ... etc. the armed project (2012-2015) funded by the ansm, whose goal was to prioritizing the risk linked to the migration of these plasticizers from mds, has shown that totm and deht present the best benefit / risk ratio due to lower migration and cytotoxicity. nevertheless, it is important to evaluate the level of exposure of neonatal intensive care patients, due to the multi exposure to md made of pvc, the frequent use of intravenous route and the vulnerability of this at-risk population to the metabolites of these plasticizers.

the purpose of this biomonitoring study consists to evaluate the exposure of newborns and premature babies hospitalized in nicu to these plasticizers (deht and totm), by qualitative and quantitative measurement of their urinary metabolites

Eligibility criteria:
inclusion criteria: * hospitalized minor patient in nicu * hospitalized patient in one of the planned services of the study- hospital stay provided for inclusion ≥ 48 hours * patient with a urinary catheter at the time of inclusion in the study * patient undergoing during the stay at least 1 of the following medical procedures: enteral nutrition, parenteral nutrition, extra-renal purification, ecmo, transfusion, lipid infusion, plasmapheresis * patient whose parents have expressed their non-opposition to his participation in the study exclusion criteria: * death of the patient * leaving hospital * patient becoming anuric (diuresis \<1ml / kg / h for more than 24 hours) under study

Keywords: plasticizers medical devices neonates exposition
a research study to look at long-term treatment with a medicine called nnc6019-0001 for people who have heart failure due to transthyretin amyloidosis

Conditions: Transthyretin Amyloid Cardiomyopathy (ATTR CM)

Summary: this study will test a medicine, nnc6019-0001, for people who have a heart disease due to ttr amyloidosis. it will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to ttr amyloidosis, such as heart failure. it is an extension to a study called "a research study to look at how a new medicine called nnc6019-0001 works and how safe it is for people who have a heart disease due to ttr amyloidosis". only participants who have completed that study will be invited for this new study. participants will get nnc6019-0001, regardless of whether they got placebo or nnc6019-0001 in the first study. the study will last for up to 157 weeks (36 months/3 years).


Eligibility criteria:
inclusion criteria: * completed study intervention in nn6019-4940 and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16. * expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit. exclusion criteria: * a prior solid organ transplant. * presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (pin) or low-grade prostate cancer) within 5 years before screening. * current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). the use of dihydropyridine calcium channel blockers is allowed. the use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response. * body weight greater than (\>) 120 kilograms (kg) (264.6 pounds \[lb\]) at screening.
atorvastatin and sympathetic activity in chronic kidney disease

Conditions: Stable Chronic Kidney Disease; Hypertension

Summary: hypertensive chronic kidney disease (ckd) patients often have sympathetic hyperactivity which appears to contribute to the pathogenesis of hypertension and cardiovascular organ damage. experimental studies and some clinical studies have shown that statin therapy can reduce central sympathetic activity. blockade of the renin-angiotensin system (ras), which is standard treatment for ckd, is known to lower sympathetic activity. the investigators hypothesize that adding a statin for 6 weeks to ras blockade would further lower sympathetic activity in hypertensive stage 2-4 ckd patients. methods: in ten stable ckd patients who are on chronic treatment with renin-angiotenis blockers, blood pressure and sympathetic activity (quantified by assessment of muscle sympathetic nerve activity, msna) will be assessed at baseline and 6 weeks after atorvastatin 20mg/day added. ten other ckd patients will serve as time control and will be studied twice with an interval of 6 weeks without any change in medication, to quantify within subject reproducibility.

see above

Eligibility criteria:
inclusion criteria: * stable chronic kidney disease * hypertension exclusion criteria: * renal replacement therapy * pregnancy * diabetes mellitus

Keywords: sympathetic activity chronic kidney disease atorvastatin lipitor
postoperative dexamethasone on post-cesarean pain

Conditions: Post-Cesarean Pain; Cesarean Section Complications

Summary: investigating if giving post-operative dexamethasone to patients with a history of opioid use disorder on medication assisted treatment during pregnancy improves their pain scores and decreases their opioid use after cesarean section.

for this study, the researchers are most interested in an option that would be able to be administered consistently (same time/same way): that labor nurses could give and without requiring the patient to have had an epidural placement. further, gabapentin, clonidine and ketamine are associated with cns effects like sedation or confusion that could make health care providers less likely to be comfortable giving these women additional oxycodone due to possible worsened sedation or respiratory depression. lastly, the researchers wanted to give a drug that both obstetricians and pediatricians were comfortable with from extensive use in our maternal population. thus, a single administration iv dexamethasone was chosen for this study. dexamethasone has been used as an adjunct for post-operative pain management in many types of surgeries. although no large randomized trials exist, several small trials suggest an analgesic and opioid sparing effect of dexamethasone post-operatively for both pregnant and non-pregnanat patients; however these studies excluded patients on mat

Eligibility criteria:
inclusion criteria: * english-speaking, * history of opioid use disorder with current use of mat during pregnancy, * scheduled for cesarean delivery for their current pregnancy for any indication \[examples of elective c-section (decision made for c-section to be performed prior to onset of labor): fetal malpresentation, suspected macrosomia, prior c-section, abnormal placentation, patient preference\], * negative toxicology screen upon admission to the hospital for their cesarean section, no prior administration of betamethasone for fetal lung maturity within 24h of their scheduled cesarean delivery exclusion criteria: * non-english speaking, * screen positive for illicit substance(s) on their admission toxicology screen, * require general anesthesia for their cesarean section due to maternal/fetal indication for non-anticipated urgency (thus no longer 'elective') or failure of adequate intra- operative pain control with spinal anesthesia, * medical history including known cardiovascular disease, heart failure, uncontrolled hypertension, uncontrolled gestational diabetes or uncontrolled pregestational diabetes, active gi bleed or untreated peptic ulcer, * untreated infectious diseases including tuberculosis, systemic candida
effect of osteopathic techiniques on intraocular pressure

Conditions: Intraocular Pressure; Osteopathic Manipulative Treatment

Summary: the purpose of this study is to assess the effects osteopathic techniques at the upper cervical vertebrae or at the sphenopalatine ganglia on the intraocular pressure.

the 7 volunteers will be randomized into 3 groups and there will be an experimental group 1 that will receive a technique of manipulation of the upper cervical, an experimental group 2 that will receive a technique of manipulation of the sphenopalatine ganglion and a control group that will not receive any intervention. each volunteer will participate in the 3 groups. there will be 4 assessments, one before the procedure and one just after each procedure, including the control.

Eligibility criteria:
inclusion criteria: * intraocular pressure below 21mmhg exclusion criteria: * positive klein test * use of medications that affect the circulatory system in up to one month before the procedures; * caffeine use 24 hours before procedures; * presence of ophthalmic diseases; * history of hypertension or diabetes; * blindness; * tumor in the head; * skull or cervical fractures that occurred less than 6 months ago.

Keywords: intraocular pressure sphenopalatine ganglion superior cervical ganglion aqueous humour