Kornimate/medical-research-clean huggingface dataset:
hydrophobic acrylic toric iol designed to reduce the effects of preoperative corneal astigmatism

Conditions: Astigmatism

Summary: the investigational envista iol, model mx60tis equipped with toric optics and axis marks on the posterior surface to minimize the possibility of surgically induced astigmatism.

the investigational envista toric iol, model mx60t, and the currently approved model mx60, are identical with the exception of the addition of toric optics and axis marks on the posterior optic surface for the correction of astigmatism on the model mx60t. both lenses have an aspheric biconvex optic with a modified c haptic monoblock, single-piece design. the design and material of both the mx60 and mx60t allow them to be folded and inserted through small incisions to minimize the possibility of surgically induced astigmatism (sia).

Eligibility criteria:
inclusion criteria: * subjects must have a clinically significant cataract in the study eye that is considered amenable to treatment with standard phacoemulsification cataract extraction. * subjects must require a lens power from 16.0 d to 27.0 d in the study eye. * subjects must be willing to discontinue contact lens wear for the duration of the study and, demonstrate stability prior to biometry and surgery in the study eye. * subjects must have a best corrected distance visual acuity (bcdva) projected to be better than 20/30 after toric iol implantation in the study eye. * subjects must have predicted postoperative corneal astigmatism between 0.90d and 2.40d in the study eye, as determined by the toric calculator. * subjects must have a minimum preoperative corneal astigmatism of 0.90 d in the study eye. * subjects must have a dilated preoperative pupil size greater than or equal to 5.0 mm in the study eye. exclusion criteria: * subjects who have had previous intraocular or corneal surgery in the study eye. * subjects with any clinically significant ocular pathology which would be expected to reduce potential bcdva to 20/30 or worse in the study eye during the course of the study. * subjects with any anterior segment pathology in the study eye likely to increase the risk of complications from phacoemulsification cataract surgery. * subjects with associated ocular conditions which could affect the stability of the iol in the study eye. * subjects with a traumatic cataract in the study eye. * subjects with uncontrolled glaucoma in the study eye. * subjects with clinically significant irregular corneal astigmatism in the study eye, as determined by the medical judgment of the investigator. * subjects with clinically significant corneal pathology potentially affecting topography of either eye. * subjects with any ocular condition that could prevent the possibility of a visual outcome better than 20/30 in the study eye. * subjects with a difference of greater than 0.50d of corneal astigmatism as measured with the iol master and the topographer in the study eye using vector analysis. * subjects with an anterior chamber depth \<2mm in the study eye. * subjects with potential bcdva of 20/200 or worse in the fellow eye.
rocking chair therapy in elderly with dementia: its effects on agitation

Conditions: Dementia

Summary: patients with dementia exhibit a wide range of behavioral symptoms which include mood disturbances (e.g depression, anxiety), behavior and activity disturbances (e.g agitation, aggression, wandering) and psychotic symptoms (e.g hallucinations and delusions). behavioral disturbances are a major source of caregiver burden and an important contributor to the decision to admit ad patients to institutionalized long-term care. among the innovative approaches, rocking chair therapy has been introduced as a potential means for reducing agitation in elderly with dementia. only few studies evaluated the effect of this therapy on the behavioral symptoms in elderly with cognitive impairment. the results were promising, but not sufficiently significant. we propose to perform this study having as a main goal to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia. the secondary aim of the study will be the evaluation of psychoactive drugs use as well as pain killers. cohen mansfield agitation inventory will be employed for the pre- and post-therapy evaluation. included subjects will be installed in groups of five, rocking chairs will be placed away from other residents in a semicircle in a corner of the dayroom. the therapy sessions will be held every afternoon, for two hours, under the supervision of the unit psychologist and a master's degree psychology student. during the daily session, each resident should be encouraged to actively rock to reach the goal of 60 minutes of rocking accumulated per day. the total duration of the therapy period will be 6 weeks. the use of pharmacological restraint (neuroleptics, anxiolytics) and pain killers will be evaluated before, during and after the six weeks therapy. the expected outcome is a reduction of agitation among elderly with dementia, as well as a reduction in the use of pharmacological restraint and pain killers.


Eligibility criteria:
inclusion criteria: * resident of the ehpad / ltc for at least 10 weeks * subject with cognitive impairment (mmse \<24) documented according to dsm-5 criteria * with chronic behavioral disorders such as agitation * stable from a medical point of view * without restraint when not in bed * ability to touch the floor with the toes while sitting in the rocking chair * ability to sit securely in the rocking chair * ability to tolerate rocking chair * ability to maintain active rocking for at least 5 minutes over a 30-minute period during the three pre-treatment trials * obligation for all patients to be affiliated to a social security scheme * signing of the informed consent by the patient and / or his legal representative exclusion criteria: * motor deficiency (example: after-effects of stroke ...) not allowing a secure installation in the chair or preventing an active rocking * atcc with vestibular involvement that may lead to vertiginous seizures during rocking * aging psychiatric pathology
postop pain in the mics patients versus sternotomy patients

Conditions: Pain, Postoperative; Surgery

Summary: to adequately assess postoperative pain in the coronary artery bypass surgical population a multicentered retrospective chart review was carried out; the study utilized a nonexperimental comparative descriptive study design. the retrospective review was conducted over a six-month time frame, consisting of june 2017 through november 2017, at two hospitals within the same organization. the data collection process began in late december of 2017 and january of 2018. the assessment of postop pain was performed by using a standard 11-point numeric pain rating scale on post extubation day one and the day of discharge.


Eligibility criteria:
inclusion criteria: * patients who had an isolated coronary artery bypass surgery at charlotte medical center (cmc) and cmc-pineville * minimally invasive cardiac surgery * traditional sternotomy cardiac surgery exclusion criteria: * documented history of any chronic pain syndromes requiring active treatment * the "relative" recent requirement of narcotic analgesic use for pain relief prior to operation * any cabg operation that inadvertently resulted in an operative surgical complication * patient cases that resulted in a readmission within 30 days from surgery.

Keywords: minimally invasive cardiac surgery postoperative pain
managing dry eye in patients using glaucoma drops

Conditions: Dry Eye

Summary: a single center randomized controlled trial on managing dry eye signs and symptoms in patients using anti-glaucoma eye drops.

to compare the safety and efficacy of ipl therapy on drug-induced dry eye caused by long-term use of anti glaucoma drugs;

Eligibility criteria:
inclusion criteria: * age ≥18 years * able and willing to comply with the treatment/follow-up schedule * bilateral signs and symptoms of dry eye disease exclusion criteria: * participants with systemic immune-mediated illnesses, such as secondary sjögren's syndrome or graft-versus-host disease * patients using topical medication(s) for the treatment of ocular disorders such as allergic conjunctivitis were excluded from the study. * previous ocular surgery or trauma * 1-month history of blepharal and periorbital skin disease or allergies * severe dry eyes with corneal epithelial defect * limbic keratitis * pterygium * corneal neovascularization * breastfeeding * rheumatic immune systemic diseases * herpes zoster infection * pregnant women * allergic to fluorescein * contact lens wearers

Keywords: glaucoma ipl diquafosol drug-induced dry eye
a trial of strontium +/- cisplatin for the palliation of bone pain secondary to hormone refractory prostate cancer

Conditions: Hormone Refractory Prostate Cancer; Bone Metastases

Summary: this study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.

this study is designed to determine whether the combination of low dose cisplatin and strontium-89 shows clinical promise for the symptomatic treatment of bone metastases in hormone refractory prostate cancer.

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the prostate * life expectancy \> 3 months, * symptomatic from bone metastases * radiologic evidence of metastatic bone disease * stable level of pain control * \>18 years * ability to complete assessments * prior treatment (chemo) \> 4 weeks previous * discontinued anti-androgens for \> 4 weeks exclusion criteria: * prior strontium therapy * previous hemibody rt within 6 weeks * previous cytotoxic chemotherapy within 4 weeks * use of bisphosphonate medications within 4 weeks * change in steroid dose within 4 weeks * active uncontrolled infection * impending or present spinal cord compression * significant neurological disorder * impending pathological fracture * severe urinary incontinence

Keywords: prostate cancer cisplatin strontium-89 phase ii
spontaneous coronary artery dissection (scad) and autoimmunity

Conditions: SCAD; Addison Disease; Ankylosing Spondylitis; Antiphospholipid Antibody Syndrome; Celiac Disease; Crohn Disease; Dermatomyositis; Polymyositis; Guillain-Barre Syndrome; Hepatitis, Autoimmune; Graves Disease; Hashimoto Thyroiditis; Multiple Sclerosis; Myasthenia Gravis; Pernicious Anemia; Polymyalgia Rheumatica; Primary Biliary Cirrhosis; Psoriasis; Rheumatoid Arthritis; Systemic Sclerosis; Sjögren Syndrome; Systemic Lupus Erythematosus; Takayasu Arteritis; Type 1 Diabetes Mellitus; Ulcerative Colitis; Uveitis; Vasculitis; Vitiligo; Raynaud

Summary: this case control study aims to determine whether spontaneous coronary artery dissection (scad) is associated with autoimmune diseases and to update the incidence of scad in a population-based cohort.


Eligibility criteria:
inclusion criteria: * adults age 18 to 110 * residence in olmsted county. note: if sufficient numbers cannot be reached using only olmsted county, will expand to the 27-county region. exclusion criteria: * none

Keywords: spontaneous coronary artery dissection autoimmune incidence
a study of tmc207 in patients with moderately impaired hepatic function

Conditions: Moderate Hepatic Impairment

Summary: the purpose of this study is to assess the pharmacokinetics (what the body does to the medication), safety and tolerability of tmc207 and its n-monodesmethyl metabolite (m2) in healthy participants and in patients with moderate hepatic impairment after administration of a single 400 mg dose of tmc207.

this is a phase i, open label (all people know the identity of the intervention) study of tmc207. the study consists of a screening period and a 4-weeks treatment period. sixteen participants will be enrolled in two panels. panel a will include 8 patients of moderate hepatic impairment and panel b will include 8 healthy participants. safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study. the entire study duration for each participant will be approximately 7 weeks.

Eligibility criteria:
inclusion criteria: * for healthy participant panel a: healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests performed at screening * should match to a patient with hepatic impairment with regards to sex, age (more or less to 5 years), and body mass index * for patients in panel b with moderate hepatic impairment: history of hepatic disease, documented liver cirrhosis and moderate liver function impairment defined by the child-pugh classification exclusion criteria: * a positive tuberculin skin test indicating latent tuberculosis * a positive human immunodeficiency virus (hiv)-1 or hiv-2 test at screening * moderate hepatic impairment patients with acute hepatitis, hepatic carcinoma, grade 3 or 4 encephalopathy, or active candidate for liver transplantation * matched healthy participants with current active hepatic disease

Keywords: moderate hepatic impairment tuberculosis tmc207 mycobacterial adenosine triphosphate (atp)-synthase
efficacy and safety study of gb-0998 for guillain-barré syndrome

Conditions: Guillain-Barré Syndrome

Summary: this study will carry out to assess the efficacy of gb-0998 (intravenous immunoglobulin;400mg/kg/day for five days) in the treatment of the guillain-barré syndrome based on the changes in hughes functional grade (fg) as primary endpoint, and in addition, to assess the safety of gb-0998.


Eligibility criteria:
inclusion criteria: 1. in principle, patients are able to receive the treatment within 2 weeks (with limits of 4 weeks) from the start of symptoms. 2. patients with predominant motor neuropathy and fg is grade 4 or grade 5 (if symptoms is progressive, patients with fg is grade 3 involve in this study). 3. patients with plasmapheresis, steroids and immune globulin therapy is no operation for this onset. exclusion criteria: 1. patients who have the anamnesis of shock or hypersensitivity to gb-0998. 2. patients who have been diagnosed as hereditary fructose intolerance. 3. patients who have impaired peripheral neuropathy except guillain-barré syndrome. 4. patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, poliomyelitis, botulism, hysterical paralysis, toxic neuropathy. 5. patients who have received treatment of malignant tumors. 6. patients who were administered immunoglobulin within 8 weeks before informed consent. 7. patients who have been diagnosed iga deficiency in their past history. 8. patients with severe renal disorder or decreased cardiac function. 9. patients who have the anamnesis of cerebro- or cardiovascular disorders, or symptom of these diseases. 10. patients with high risk of thromboembolism. 11. pregnant, lactating, and probably pregnant patients. 12. patients who were administered other investigational drug within 12 weeks before consent.
tcm syndrome differentiation of t2dm & mets

Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome

Summary: this study aims to include type 2 diabetes (t2dm) patients comorbid with metabolic syndrome (mets). the primary aim of the study is to investigate the tcm (traditional chinese medicine) syndrome differentiation of t2dm comorbid with mets.

this study adopts a cross-sectional design, to include type 2 diabetes (t2dm) patients comorbid with metabolic syndrome (mets). the primary aim of the study is to investigate the tcm (traditional chinese medicine) syndrome differentiation of patients with t2dm and mets. the demographic data, anthropometric data, fasting glucose and hba1c, lipid panel, tcm syndrome differentiation information, dietary assessment, physical activity, sleep quality, and quality of life, will be assessed.

Eligibility criteria:
inclusion criteria: * (1) age between 18-75y. * (2) diagnosed with type 2 diabetes. * (3) diagnosed with metabolic syndrome according to guideline for the prevention and treatment of type 2 diabetes mellitus in china (2020 edition) from chinese diabetes society. people who meet 3 of the following diagnostic criteria or more can be diagnosed as metabolic syndrome: (a) abdominal obesity: waist circumference ≥ 90cm for male and ≥ 85cm for female; (b) hyperglycemia: fasting blood glucose ≥ 6.1mmol/l or 2-hour postprandial glucose ≥ 7.8mmol/l and/or those who have been diagnosed with hyperglycemia and in treatment; (c) hypertension: blood pressure ≥ 130/85mmhg and/or those who have been diagnosed with hypertension and in treatment; (d) fasting triglyceride ≥ 1.70mmol/l; (e) fasting hdl-c \< 1.04mmol/l. * (4) clearly understand the content of the study and voluntarily sign the informed consent form. * (5) provide complete data (basic information, tcm diagnosis data, and blood test results). exclusion criteria: * (1) diagnosed with type 1 diabetes, steroid-induced diabetes, gestational diabetes, or specific types of diabetes. * (2) diabetes accompanied by severe complications such as diabetic nephropathy, diabetic ketoacidosis, etc. * (3) secondary obesity (e.g., secondary to pituitary inflammation, tumor, etc.). * (4) secondary hypertension (e.g., pheochromocytoma, renal hypertension, etc.). * (5) secondary hyperlipidemia (e.g., hypothyroidism, nephrotic syndrome, etc.). * (6) with severe heart, liver, or kidney disease or bleeding disorders, or with other serious diseases (e.g. cancer, dementia, etc.). * (7) with severe mental disorders, speech or hearing impairments. * (8) pregnancy or lactation female. * (9) currently join other clinical trial.
scleral contact lens insertion solution study

Conditions: Irregular; Contour of Cornea

Summary: the purpose of this study is to determine the clinical ocular compatibility (feasibility of safety and efficacy) of a patented solution (us patent 2,259,437, stone) which contains multiple essential ions and has a ph and tonicity which more closely mimics human tears as compared to the subjects' current habitual scleral lens insertion solution.

the sterile solution is provided by prescription for each patient by a local compounding pharmacy in unit dose containers. the initial exposure - filling the posterior bowl of the scleral contact lens by the investigator and applying the lens to the eye - will be monitored in the office for one hour, prior to any dispensing of the solution to the patient for their use at home or work. this is a one week, unmasked comparison of the new solution to the subject's habitual solution used for scleral lens insertion. the (historical) control is the saline habitually used by the subjects. the sample size is determined to be manageable to insure close supervision of the subjects in these initial trials and to inform us for future safety and efficacy trials. the primary safety outcome measure will be slit lamp examination of the ocular anterior segment and the secondary outcome measure will be photo-documentation by ocular coherence tomography of the clouding of the tears between the cornea and scleral contact lens. the primary efficacy outcome will be ocular comfort as assessed by questionnaire.

Eligibility criteria:
inclusion criteria: * age 18 years and older. * wear a scleral contact lens habitually 6 or more hours a day. * needs to remove scleral lens due to fogging and refill or definitely reports fogging. * must have worn habitual scleral lens for at least 3 months * willing and able to attend study visits. exclusion criteria: * currently under treatment for an eye infection or inflammation such as adapted keratoconus or healed post penetrating keratoplasty. stable keratoconus is acceptable. * currently taking topical ophthalmic prescription medications. * current medical eye complications such as glaucoma or uveitis. * recent corneal surgery * sjogrens or other clinically significant active ocular surface disease.

Keywords: contact lens solution
nanotech rcc biomarkers

Conditions: Renal Cell Carcinoma; Renal Cell Cancer

Summary: the incidence of renal cell carcinoma (rcc or kidney cancer) in men exceeds that of pancreatic cancer or leukemia. in women, the incidence of rcc is similar to that of leukemia, ovarian, or pancreatic cancer; thus, rcc is significant health issue. this study focuses on identifying specific molecules \[biomarkers\] of rcc that can be used to develop a reliable low-cost screening method at the point of service. if successful, our method would provide a diagnostic test to distinguish benign kidney masses from malignant ones, eliminating the need to surgically remove a kidney with a benign tumor.


Eligibility criteria:
inclusion criteria: patients 18 years of age and older undergoing surgery. patient samples are divided into 2 groups based on their surgery: patients with an imaged renal mass, encompassing about 300 patients/year (about 1200 total) of both malignant (about 80-85% of time) and benign (about 15-20% of time), and patients with non-kidney cancers, encompassing about 6,000 patients/year (about 24,000 total), exclusion criteria: age \<18 years and prisoners.
brain function and white matter changes in congenital, acute and chronic spinal cord lesions

Conditions: Paraplegia, Spinal; Myelomeningocele

Summary: the purpose of this study is to use functional mri (fmri) and magnetic resonance (mr) diffusion tensor imaging (dti) to investigate brain activation and white matter changes in patients with congenital (birth defect of the spinal column), acute and chronic complete spinal cord lesions. the findings of this study may provide a basis to better understand the pathomechanisms underlying the dynamic neurofunctional changes following a spinal cord lesions in man. this understanding is important for the improvement of existing therapies and for the development of new therapeutic approaches.

recently new approaches to spinal cord repair have been successfully established in animal models. promising therapies for promoting spinal axonal regeneration in man will be available in the near future. most research in the field is focussed on the lesion itself and the perilesional spinal cord. the recovery of motor and sensory function is,however, not permitted by local processes at the spinal level only. the whole central nervous system (cns) reacts to such a condition. therefore the modulation of motor and sensory function in spinal cord lesioned patients should be reflected in characteristic changes of cortical brain activity, which are accessible to new non-invasive functional neuroimaging techniques such as functional magnetic resonance imaging (fmri). changes of white matter due to axonal damage can also be measured qualitatively and quantitatively using mr diffusion tensor imaging (dti). those measures may provide a basis to better understand the pathophysiology underlying spinal cord lesions in man, including changes in brain function over time (during rehabilitation) or related to specific treatment. however, there are no studies available yet addressing those topics or providing mechanism-based approaches for determining the time interval of application of novel neuroregenerative drugs. by investigation of brain activation and white matter changes in patients with congenital(myelomeningocele (mmc)), acute and chronic spinal cord lesions (asia a) first and fundamental work in this field will be conducted in this study.

Eligibility criteria:
inclusion criteria: * paraplegic patients (th1-th12, asia a), * myelomeningocele patients (th1-th12 asia a) * acute sci 2-6 months, chronic sci 12-24 months exclusion criteria: * traumatic brain injury (tbi) * neurological diseases other than spinal cord lesion * mri incompatibility * pressure sores * methicillin-resistant staphylococcus aureus (mrsa)

Keywords: functional mri,primary motor cortex,spinal cord injury