Kornimate/medical-research-clean huggingface dataset:
cervical orthosis versus no orthosis following multi-level posterior cervical fusion

Conditions: Posterior Cervical Spinal Surgery; Myelopathy Cervical; Radiculopathy, Cervical; Spinal Stenosis Cervical; Spondylosis, Cervical

Summary: use of cervical orthosis after instrumented posterior cervical spinal surgery is still widely practiced even though modern fusion techniques likely do not require additional stabilization from an external orthosis. this is a single, centre randomized, non-blinded equivalence trial. patients undergoing multi-level posterior cervical fusion will be randomized to cervical orthosis (co group) or no orthosis (no group). immediately following surgery patients in the co group will be fitted with a philadelphia collar prior to being transferred to the recovery room. on the patient ward a physiotherapist will fit the patient with a cervimax/aspen/miami j collar which will be worn at all times for 6 weeks according the standard of care. the no group will have no specific precautions applied to their neck range of motion. outcomes will be assessed prior to surgery, on the second day after surgery, and at 2, 4, 6 and 12 weeks after surgery. the primary outcome will be neck pain score on the numerical rating scale (ranging from 0-10 with higher scores indicating more severe pain) during the first 4 weeks after surgery with an equivalence margin of 2.0 points. secondary outcomes will be neck disability, general health, treatment satisfaction, pain medication use, adverse events, neck range of motion, time meeting discharge status, and compliance in wearing the collar.


Eligibility criteria:
inclusion criteria: 1. undergoing multi-level (2- or more level), open, posterior cervical fusion which may extent into the second thoracic vertebrae (c1-t2) 2. able to consent to inclusion in the study 3. 18 years of age and older exclusion criteria: 1. spinal cord injury 2. primary cervical spine infection 3. cervical spine tumor 4. inability to comprehend patient rated outcome instruments 5. substance abuse 6. dementia 7. psychosis 8. previous surgery at same level
to evaluate efficacy and safety of parsaclisib plus either rituximab or obinutuzumab in r/r follicular lymphoma (fl) and marginal zone lymphoma (mzl) (citadel-302)

Conditions: Follicular Lymphoma ( FL); Marginal Zone Lymphoma (MZL)

Summary: this is a phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus investigator's choice of either rituximab or obinutuzumab versus placebo plus investigator's choice of rituximab or obinutuzumab for the treatment of participants with r/r fl or mzl. the participants will be stratified in a 1:1 randomization ratio by investigator's choice of rituximab or obinutuzumab prior to randomization, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (mzl or fl) .


Eligibility criteria:
inclusion criteria: * male and female participants aged 18 years or older (japan, aged 20 years or older). * histologically confirmed grade 1, 2, or 3a fl or nodal mzl, splenic mzl, or extra nodal mzl * prior systemic treatment with at least 1 anti-cd20 mab (either as monotherapy or in combination as chemoimmunotherapy) * documented disease that has relapsed or progressed or was refractory after the most recent prior systemic therapy. note: participants must not be refractory to anti-cd20 mab * radiographically (ct, mri) measurable lymphadenopathy per the lugano criteria for response assessment (cheson et al 2014). * ecog ps of 0 to 2 * adequate organ functions including hematopoiesis, liver, and kidney * willingness to avoid pregnancy or fathering children exclusion criteria: * women who are pregnant or breastfeeding. * known histological transformation from indolent nhl to an aggressive nhl (eg, diffuse large b-cell lymphoma). * presence of cns lymphoma (either primary or secondary) or leptomeningeal disease. * prior treatment with pi3k inhibitors. * inadequate washout of immunosuppressive therapy, anticancer medications and investigational drugs. * significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, gi, endocrine, pulmonary, neurological, cerebral, cardiac, infectious, or psychiatric disease. * known hiv infection. * hbv or hcv infection: participants positive for hbsag or anti-hbc will be eligible if they are negative for hbv-dna; these participants must receive prophylactic antiviral therapy. participants positive for hcv antibody will be eligible if they are negative for hcv-rna. * history of other malignancy within 2 years of study entry. * any condition that would, in the investigator's judgment, interfere with full participation in the study.

Keywords: parsaclisib relapsed/refractory obinutuzumab rituximab
efficacy of a nasal spray containing iota-carrageenan in the prophylaxis of covid-19 disease in health personnel dedicated to patients care with covid-19 disease

Conditions: Covid19

Summary: coronaviruses are enveloped viruses with an rna genome. carrageenans are sulfate polysaccharides synthesized by red algae. studies conducted in adults and children with the common cold showed the effectiveness of the use of carrageenan in nasal spray. for decades, the antiviral action of carrageenans has been described in numerous studies with different viruses that infect humans: herpes viruses types 1 and 2, human immunodeficiency virus, human papillomavirus, h1n1 influenza virus, dengue virus, rhinovirus, hepatitis a virus, and enteroviruses. studies on the dynamics of covid-19 disease show an intense and rapid pharyngeal multiplication in the first 3-5 days of the onset of symptoms, prior to the onset of pulmonary disease. finally, this molecule has shown a viricidal effect against sars-cov2 in vitro. all this underscores the potential value of a therapy that inhibits the virus in the rhinopharynx.

this is a multicenter, randomized, double-blind, placebo-controlled trial assessing the use a nasal spray containing iota-carrageenan in the prophylaxis of covid-19 disease in health-workers.

Eligibility criteria:
inclusion criteria: * physician, nurses, and physical therapist who usually attend hospitalized covid19 patients. * no more than 48 hours since he/she assisted a covid-19 patient * able to understand and give written informed consent exclusion criteria: * participation in any other clinical trial of an experimental treatment for covid-19 * not having a cell phone with whatsapp for remote monitoring * hypersensitivity or known allergy to any component of the product * pregnancy or lactation
a study to test the diagnostic potential of brillouin microscopy for corneal ectasia

Conditions: Keratoconus; Ectasia; Crosslinking; Fuchs' Endothelial Dystrophy

Summary: we have developed novel brillouin microscopy and we are testing its potential for keratoconus and ectasia diagnostics. we plan to perform axial scans of the cornea in human volunteers in order to compare biomechanical properties of keratoconus vs. normal corneas and compare biomechanical properties of post-lasik ectasia vs. normal corneas.


Eligibility criteria:
inclusion criteria: group i includes healthy subjects with normal appearing corneas, normal topography and pachymetry. group ii includes patients diagnosed as having mild, moderate or advanced keratoconus by our ophthalmology expert on the basis of topography and pachymetry. group iii includes healthy subjects who have undergone lasik surgery in the past 12 months without complications. inclusion criteria include normal post-operative topography and pachymetry. group iv includes patients (age 20 - 60) who have undergone lasik surgery at least 12 months before the study imaging and have been diagnosed with post-lasik ectasia based on topography, pachymetry and clinical evaluation.patients diagnosed with keratoconus. group v- volunteers to receive prk surgery this group includes patients who have been diagnosed with myopia and have been scheduled to undergo prk surgery. patients with high astigmatism \> 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen or artificial tears will be excluded. group vi-volunteers to receive lasik surgery this group includes myopic patients who are scheduled to receive lasik surgery. patients with high astigmatism \> 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen and artificial tears will be excluded. group vii- patients with fuch's endothelial corneal dystrophy. this group includes subjects who are diagnosed with fuch's corneal dystrophy, at early, mild and advanced stages. the inclusion also extends to subjects with, and without keratoconus. but this exclude patients with any other corneal disorders other than keratoconus, and/or history of ophthalmological surgeries that may affect endothelium cell status, e.g. cataract surgeries. overall exclusion criteria for all groups: volunteers who * have occludable narrow angles (without a patent peripheral iridotomy) * monocular subjects * do not or cannot understand the instructions for the imaging

Keywords: lasik
sensitivity study of diagnostic for early detection of dengue infection

Conditions: Infectious Diseases

Summary: this study is a multi-site trial assessing the sensitivity of denv detect™ ns1 elisa versus standard reference tests (e.g. pcr or viral culture) for dengue diagnosis in the us and internationally. the denv detect™ ns1 elisa serves as an aid in the clinical laboratory diagnosis of early stages of dengue infection in patients with clinical symptoms consistent with dengue infection. this test is intended to be used on sera obtained within the first 7 days of symptoms. denv detect™ ns1 elisa results (positive or negative) must be confirmed by testing with a reference standard test. subjects will be patients who present with symptoms consistent with dengue infection, such as fever and myalgia. after informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected. the first will be collected within the first 7 days of symptoms onset, and the second will be collected at least 7 days later, between the 10th and 21st days post-onset of symptoms. elisa and reference tests will be performed by different operators who are laboratory staff members. these staff members, blinded to each other's results, will evaluate the samples from each method independently.


Eligibility criteria:
inclusion criteria: * all age groups and both sexes. * initial serum samples must be collected within 1- 7 days of onset of symptoms consistent with dengue virus infection. * information must be available about symptoms, age, and sex of patient from which samples are collected. * the location of sample collection must be recorded. * archived samples that have been sent to reference labs for dengue or flavivirus testing should be considered for inclusion as test specimens in this study. if these specimens are included in this study, then they must have a documented history that the specimen was obtained within the first 7 days of onset of subject symptoms consistent with dengue infection. exclusion criteria: * archived samples with linked personal identifiers or any sample for which personal information can be discovered. * prospective samples from nursing home residents; inmates/subjects in police custody; participants who are unable to understand verbal or written local language in which a certified translation of the informed consent is available, or requires a legal authorized representative (lar) for consent. * subject serum specimens that have undergone more than 2 freeze-thaw cycles or that have not been stored frozen.
risk factors for benign breast disease

Conditions: Benign Breast Disease

Summary: benign diseases of the breast are common clinical conditions that affect young women. complaints related to the breast often cause significant discomfort and mental stress. the following study will try to identify the risk factors that may be associated with symptomatic benign breast diseases. identification of such factors may help preventing and / or treating these conditions.

benign breast disease (bbd) is a common cause of hospital visit. in young adults, benign breast conditions surpass cancer as a cause of symptoms related to the breast. however, breast symptoms may be associated with significant distress and may impose diagnostic difficulties. moreover, certain pathological entities of benign breast conditions are well known to increase the risk of breast cancer. identification of modifiable risk factors associated with symptomatic breast disorders has several potential benefits. modification of such factors may help decrease patients' distress, hospital visits and indirectly decrease the risk of cancer. the available data point to the possible association of several environmental factors with symptomatic bbd. most of the available information points to an association of bbd with anthropometric features, growth pattern, family history of breast conditions and dietary consumption. substantial evidence are however lacking and further studies are strongly required to better characterize the risk factors of the condition. in this study, the investigators will systematically collect epidemiological, developmental and clinical data in young patients presenting with breast complaints. the association with disease incidence, pattern and histology will be examined.

Eligibility criteria:
inclusion criteria: * adult females with current symptoms related to the breast. exclusion criteria: * current or past malignancy of the breast. * discrete breast mass that necessitate work-up to exclude cancer. * current psychiatric morbidity. * persons unwilling to participate.

Keywords: benign breast disease fibrocystic disease
effects of unilateral vibration on contralateral forearm muscle activity

Conditions: Osteoporosis; Excitability

Summary: this study hypothesize that radius subjecting to mechanical loading may affect excitability of alpha motor neuron innervating muscle, based on its bone mineral density or bone mineral content. a total of 80 voluntaries are planned to include in this study. vibration will be applied the right forearm. muscle electrical activity will be measured on ipsilateral and contralateral flexor carpi radialis (fcr) muscle at rest as emgrms by surface electromyography (emg). the rest-emgrms will be measured at before and during vibration. an increase in muscle electrical activity at rest indicates an increase in motor neuron pool activation. the right distal radius bone mineral content (bmc) and density will be measured by dual energy x-ray absorptiometry (dxa). the right radius bone mineral density (bmd) and bmc will be evaluated by bone densitometer (ge-lunar dpx pro). motor unit potentials will be measured by electromyography at left flexor carpi radialis. neurotrac ets device will be used.

a functional cooperation exists between bones and skeletal muscles. bones work together with muscles as a simple mechanical lever system to produce body movement. one of the important functions of bones is to exert resistance against gravity in order to carry the body. in order to carry out their mechanical functions, bones need to have considerable resistance to deformation under load. it is well-known that muscle activity (i.e., exercises) improves the resistance of bone to mechanical loading, and that it is also important for treating and preventing osteoporosis. resistance and impact training have been shown to induce bone formation and/or prevent bone resorption. skeletal muscles have positive effects on bone structure and function. can bones have an effect on muscle activity? there is only one study about the effect of bones on muscles. in this study, it was shown that bones may affect muscle strength gain in healthy young adult males. vibration has a strong osteogenic effect. vibration-induced bone formation is neuronally regulated. vibration can also effectively enhance muscle strength and power. previous studies have shown that vibration increases muscle electromyographic (emg) activity. but, it has not been reported whether bone has an effect on the increase in muscle emg activity caused by vibration or not. the aim of this study was to determine whether radius bone exposed to cyclic mechanical loading affects muscle electrical activity of contralateral untrained m. flexor carpi radialis in healthy adult volunteers.

Eligibility criteria:
inclusion criteria: * healthy subjects * right handed * young adult women and men exclusion criteria: * secondary osteoporosis * neuropathy (central or peripheral) * myopathy * systemic diseases (arthritis, endocrine-metabolic diseases, bone diseases) * professional sportswoman/sportsman * subjects doing regular sports activities * tendinopathy * amputee, endoprosthesis, metal implants

Keywords: bone motor neuron excitability forearm vibration mechanical loading muscle electrical activity
the effect of sujok therapy on urinary incontinence and quality of life in postmenopausal women

Conditions: Urinary Incontinence (UI); Postmenopause

Summary: this study aims to investigate the effect of su jok therapy, a complementary medicine practice, on urinary incontinence and quality of life among postmenopausal women. a total of 120 participants will be included in the study, with 60 in the intervention group and 60 in the control group. participants in the intervention group will receive su jok seed therapy applied to the hand reflex points corresponding to the bladder. the therapy will be administered by the researcher and then taught to the participants, who will continue the application for 15 days. assessments will be conducted at baseline, day 15, and day 30 using validated questionnaires.


Eligibility criteria:
inclusion criteria: women under 65 years of age in the postmenopausal period, literate, no speech or communication impairment exclusion criteria: use of diuretics presence of nephrotic syndrome diagnosis of diabetes or hypertension symptoms of urinary tract infection diagnosis of psychiatric illness history of urinary tract surgery diagnosed urinary prolapse failure to complete the intervention

Keywords: su jok therapy urinary incontinence quality of life postmenopausal women
total30 sphere contact lenses

Conditions: Contact Lens Complication; Dry Eye

Summary: the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft cl wearers who are refit in total30 sphere cls.

contact lens (cl) wearers frequently face eye discomfort symptoms, especially towards the end of the wear day. this burdensome discomfort can unfortunately cause patients to remove their cls before their desired wear time. while comfortable wear times vary from patient to patient, terry et al. has suggested that patients should be able to comfortably wear their cls for at least 12 hours per day for at least 6 days per week. nevertheless, the literature currently lacks sufficient data to comment fully on the full day wear experience, which for many patients may be 16 or more hours per day, especially if they have demanding careers. one cl that has the potential to allow for all day comfort is the total30 sphere cls, which is a new water gradient, monthly cl aimed at delivering all day comfort and visual performance. thus, the purpose of this study is to map comfort over the full wear day in established, asymptomatic, soft cl wearers who are refit in total30 sphere cls. these data are not only important for judging the performance of total30 sphere cls, but they will provide some of the first insights into the full day cl wearing experience over one month.

Eligibility criteria:
inclusion criteria: * current contact lens wearers who have 20/20 visual acuity or better * minimally symptomatic as based upon contact lens dry eye questionnaire scores (≤10) * astigmatism better than or equal to 0.50 d in each eye * must have regularly worn 2 week or monthly contact lenses within the past 6 months * must provide a glasses prescription that is is less than 3 years old * willing to start wearing their contact lenses between 6:00 am and 8:00 am and wear their contact lenses until 11:00 pm each day exclusion criteria: * past or current hard cl use * any known systemic health conditions that are thought to alter tear film physiology * history of viral eye disease * history of ocular surgery * history of severe ocular trauma * active ocular infection or inflammation * currently using isotretinoin-derivatives * currently using ocular medications * currently using rewetting drops or artificial tear * pregnant or breast feeding

Keywords: total30 sphere contact lenses; comfort; dryness; visual analog scale scores
spinal plasticity to enhance motor retraining after stroke

Conditions: Stroke; Cerebrovascular Accident; Hemiparesis

Summary: the objective of this project is to study the effects of an emerging noninvasive neuromodulation strategy in human stroke survivors with movement-related disability. muscle weakness after stroke results from the abnormal interaction between cells in the brain that send commands to control movement and cells in the spinal cord that cause muscles to produce movement. the neuromodulation strategy central to this project has been shown the strengthen the physical connection between both cells, producing a change in movement potential of muscles weakened by stroke.

stroke is a leading cause of serious long-term disability in the united states with 795,000 individuals suffering a new or recurrent stroke each year. in most cases, disability is associated with incomplete motor recovery of the paretic limb. full recovery is often not achieved, creating a need for neuromodulation strategies that target the physiological mechanisms impaired by stroke to fully harness the adaptive capacity of the nervous system. the neuromodulation protocol that will be tested in these experiments will target connections between the brain and spinal cord with noninvasive stimulation to enhance movement potential of the hand. individuals who experienced a single stroke at least 6 months ago may be eligible to participate.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 75 years old * diagnosis of first-ever stroke * stroke onset of at least six months prior to the time of participation exclusion criteria: * history of seizure or epilepsy * ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for subjects undergoing mri) * pregnant or expecting to become pregnant * difficulty maintaining alertness and/or remaining still * body weight \> 300 lbs due to mri scanner dimensions (for subjects undergoing mri) * cognitive or language impairments that would interfere with the ability to follow simple instructions, as judged by the investigators * diagnosis of movement disorder(s) other than stroke

Keywords: neuromodulation transcranial magnetic stimulation (tms) electrical stimulation