Kornimate/medical-research-clean huggingface dataset:
monitoring & mitigation of neurologic injuries to optimize resilience after repetitive head impacts

Conditions: Head Injuries

Summary: the purpose of this phase 2, double-arm study is to identify repetitive, non-concussive head impacts that impair neurologic functioning, and to test treatments that can mitigate these effects and return functioning to normal as quickly as possible.

up to 350 total collegiate athletes and athlete-cadets will be enrolled. approximately 290 participants participating in varsity contact sports (e.g. soccer, football, etc.) at colleges/universities or military colleges, and up to 60 non-contact athletes/cadets participating in non-contact varsity sports (e.g. swimming, tennis, etc.) will be recruited as controls for the observational arm; approximately half the participants will be female.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * collegiate athlete or athlete-cadet anticipated to be an active member of a varsity sport team. exclusion criteria: * any head, neck, or face injury in the 3 months prior to enrollment that precludes participation in contact sports or wearing a mouth guard sensor * history of neurological or psychiatric disorders or neurological disorders that impact electrical activity in the brain (such as seizure disorders), or diagnosed learning disability, that in the opinion of the investigator, would interfere with participation in the study. * participants currently undergoing active treatment for migraine, depression and/or anxiety or adhd will not be excluded as these are high prevalence conditions in the adolescent and collegiate population (8-30%). however, exploratory stratified analyses will be conducted where possible. * participants with eye conditions or diseases that could impact the blood vessels in the eye. * determination that the participant is unsuitable for study entry or potentially unable to complete all aspects of the study based on the judgement of the site investigator or study pi.

Keywords: repetitive head impacts
t cell function in chronic idiopathic urticaria

Conditions: Chronic Urticaria

Summary: chronic idiopathic urticaria (ciu) is a common form of chronic urticaria in which the cause is not detected after intensive clinical and laboratory investigation.in view of the current data, it was suggested that at least part of the patients with ciu have an autoimmune process.this study is designed to investigate the mechanisms involved in the regulation and activation of the immune cells in patients with ciu and corelate them with disease activity


Eligibility criteria:
inclusion criteria: * age above 18 * chronic urticaria exclusion criteria: * age below 18 * pregnancy * other severe chronic diseases
postmarket outcomes study for evaluation of the superion™ spacer

Conditions: Lumbar Spinal Stenosis

Summary: to compile real-world outcomes of the superion™ ids in routine clinical practice.

the purpose of this outcomes study is to compile real-world outcomes for the commercially approved indirect decompression systems (ids) in routine clinical practice when used according to the applicable instructions for use.

Eligibility criteria:
key inclusion criteria: * scheduled to receive or previously received a commercially approved boston scientific indirect decompression systems, per local instructions for use (ifu) * signed a valid, irb approved informed consent form key exclusion criteria: * meets any contraindication in bsc indirect decompression systems local ifu
safety and effectiveness of giving two nucleoside reverse transcriptase inhibitors alone or in combination with 141w94 to hiv-infected children who have never received protease inhibitors

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to add a new protease inhibitor (pi), 141w94, to an anti-hiv regimen that includes 2 nucleoside reverse transcriptase inhibitors (nrtis).

in this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to receive 2 nrtis plus either 141w94 or placebo. enrollment of patients is sequential: patients 13 to 18 years of age are enrolled first, followed by children \< 13 when the appropriate pediatric dose has been determined. patients who are unable to swallow capsules will be accrued when a liquid formulation becomes available.

Eligibility criteria:
inclusion criteria your child may be eligible for this study if he/she: * is 6 months - 18 years of age. * is hiv-positive. * has a viral load (level of hiv in the body) greater than 10,000 copies/ml. * is able to take medications by mouth. * has consent of parent or legal guardian if under 18. * has a negative pregnancy test within 7 days of study entry. * agrees to practice abstinence or use effective methods of birth control for 1 month before and throughout the study. exclusion criteria your child will not be eligible for this study if he/she: * has a serious illness, including any life-threatening infection or other chronic serious medical condition. * has an opportunistic (aids-related) infection or a serious bacterial infection. * is allergic to nrtis. * is breast-feeding. * is unlikely to complete the study. * has received certain medications. * has received radiation therapy within the past 4 months, or will need to receive it during the study.

Keywords: hiv-1 drug therapy, combination hiv protease inhibitors rna, viral vx 478 reverse transcriptase inhibitors anti-hiv agents viral load
comparative study of 1000 centistoke versus 5000 centistoke silicone oil for repair of complex retinal detachments

Conditions: Retinal Detachment; Vitrectomy; Proliferative Vitreoretinopathy; Diabetic Retinopathy

Summary: the purpose of this study is to assess the retinal redetachment rates with 1000 centistoke versus 5000 centistoke silicone oil tamponade for repair of complex retinal detachments.

as part of retinal detachment surgery, the eye is typically filled with a gas bubble or silicone oil bubble. this bubble acts like a balloon inside the eye and helps to keep the retina pushed back against the eye wall so it can heal in its proper place. gas bubbles spontaneously dissolve over a few weeks whereas silicone oil remains in the eye until removed with another surgery. when retinal detachments are associated with significant scar tissue on the retinal surface, silicone oil is often used since it can remain filling the eyeball for as long as necessary to help the retina to heal properly in place. currently, two different types of silicone oil (1000 centistoke and 5000 centistoke) are commercially available and have been approved for use in the eye by the food and drug administration. the goal of the study is to compare the outcomes using these two different types of silicone oil. the retinal detachment will be repaired in a standard fashion. there will be no difference between the way retinal detachments are repaired in this study compared to those not in this study. patients will be randomly assigned (like a flip of a coin) to receive one of the types of silicone oil. both types of oil have very similar characteristics. the primary difference is that one type is thicker (more viscous) than the other, analogous to honey in comparison with maple syrup.

Eligibility criteria:
inclusion criteria: * presence of rhegmatogenous retinal detachment or tractional retinal detachment due to grade c or worse proliferative vitreoretinopathy or proliferative diabetic retinopathy. * judgment by the investigator that silicone oil tamponade is surgically indicated for appropriate repair of the complex retinal detachment. * visual acuity of light perception or better. * ability to provide written informed consent and comply with study assessments for the full duration of the study. exclusion criteria: * inability to re-attach the retina at the time of surgery. * prior trabeculectomy or tube shunt surgery. * corneal opacity which limits visualization of the trabecular meshwork.

Keywords: retinal detachment proliferative vitreoretinopathy diabetic retinopathy vitrectomy silicone oil
low dose lung ct scan for quantitative analysis in ards patients

Conditions: Acute Respiratory Distress Syndrome (ARDS)

Summary: we aimed to assess the accuracy of visual and quantitative analysis performed on low radiation dose lung ct scan (30-60 mas)compared with that performed on standard radiation dose lung ct scan (110 mas), in ards patients. if the results in computing lung recruitment will be similar, we will be able to use low dose ct scan for monitoring of the evolution of the disease in ards patients.


Eligibility criteria:
inclusion criteria: * acute respiratory distress syndrome * ct scan performed for clinical purposes exclusion criteria: * age \< 18 years * hemodynamic instability

Keywords: acute respiratory distress syndrome (ards)
analysis of pedicle screw accuracy to plan using medtronic mazor robotic system

Conditions: Spinal Deformity; Spinal Infection; Trauma; Neoplastic Processes; Degenerative Spinal Conditions

Summary: the purpose of the study is to assess screw deviation from pre-planned trajectory using the mazor x robotic system in patients undergoing posterior thoracolumbar arthrodesis procedures between t2-s1.

this trial will prospectively evaluate screw deviation from pre-planned trajectory using the standard of care mazor x robotic system. patients undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation at previously uninstrumented levels for degenerative conditions, spinal deformity, spinal infection, trauma, or neoplastic processes between t2-s1 will be asked to participate in this prospective cohort study. this single centered study will enroll up to 50 patients to achieve a total number of 250 screws for assessment. subjects will be followed till discharge following surgery. all subjects enrolled in the study will be recruited from a pool of subjects eligible for posterior thoracolumbar arthrodesis surgery.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * degenerative conditions, spinal deformity, spinal infection, traumatic injuries, or neoplastic processes between t2-s1 necessitating placement of pedicle screw instrumentation. * surgery performed at the ohio state university wexner medical center (osuwmc) via one of the study investigators exclusion criteria: * current or previous spinal tumor * severe co-morbidities (e.g., heart, respiratory, or renal disease) * concurrent involvement in another investigational drug or device study that could confound study data * subjects who are pregnant * prisoner * subjects who do not speak english relative exclusion criteria * prior pedicle screw instrumentation at that level (i.e. prior l4-5 instrumentation, now undergoing an l4-s1 fusion, only new s1 screw accuracy would be evaluated in this patient)
almorexant (act-078573) in elderly subjects with chronic primary insomnia

Conditions: Chronic Primary Insomnia

Summary: a 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (act 078573) in elderly subjects with primary insomnia.


Eligibility criteria:
inclusion criteria: * elderly subjects (\> 64 years) with a diagnosis of primary insomnia. exclusion criteria: * history of any sleep disorder, or any diagnostic and statistical manual of mental disorders iv (dsm-iv) axis i disorder other than primary insomnia. * sleep apnea, or restless legs syndrome. * daytime napping of more than 1 hour per day. * important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit. * unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.

Keywords: insomnia elderly sleeplessness
study of orgn001 (formerly alxn1101) in neonates, infants and children with molybdenum cofactor deficiency (mocd) type a

Conditions: Molybdenum Cofactor Deficiency, Type A

Summary: to evaluate the safety and efficacy of orgn001(formerly alxn1101) in neonate patients with mocd type a


Eligibility criteria:
patients must meet all of the following inclusion criteria to be considered for enrollment in this study: 1. male or female neonatal patient (1 to 28 days of age \[inclusive\] at the time of orgn001 administration, with day 1 of age corresponding to the day of birth) or infant (29 days to \<2 years of age) or child (2 to 5 years of age \[inclusive\]) with mocd type a, previously untreated with orgn001 or treated with orgn001 through compassionate use/individual named patient access 2. in neonates, diagnosis of mocd type a, based on: prenatal genetic diagnosis, or onset of clinical and/or laboratory signs and symptoms consistent with mocd type a (eg, seizures, exaggerated startle response, high-pitched cry, axial hypotonia, limb hypertonia, feeding difficulties, elevated urinary sulfite and/or ssc, elevated xanthine in urine or blood, or low or absent uric acid in the urine or blood) within the first 28 days after birth 3. in infants or children, diagnosis of mocd type a, based on: confirmed genetic diagnosis (genetic confirmation of the diagnosis of mocd type a may be obtained after initiation of orgn001 therapy in certain cases), biochemical profile, and clinical presentation consistent with mocd type a 4. parent or legal guardian must have signed the informed consent form (icf) prior to any study procedures being performed patients will be excluded from participating in the study if they meet any of the following criteria: 1. diagnosis other than mocd type a (may be determined after the initiation of study drug) 2. condition that is considered by the treating physician to be a contraindication to therapy, including evidence of abnormalities on brain imaging not attributable to mocd type a, or that might otherwise interfere with the patient's participation in the study, pose any additional risk for the patient, or confound patient assessments 3. antenatal and/or postnatal brain imaging prior to initiation of treatment with orgn001 that indicates cortical or subcortical cystic encephalomalacia, clinically significant intracranial hemorrhage, or other abnormalities on brain imaging determined by the treating physician to be clinically significant 4. modified glasgow coma scale (mgcs) for infants and children score of less than 7 for more than 24 hours (does not apply to children less than 1 day in age).

Keywords: molybdenum cofactor deficiency (mocd) molybdenum cofactor (moco) biosynthesis sulfite oxidase (so) s sulfocysteine (ssc) xanthine oxidoreductase aldehyde oxidase
edoxaban treatment in routine clinical practice in patients with venous thromboembolism in europe

Conditions: Venous Thromboembolism

Summary: according to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (vte) recurrence and bleeding. current data for edoxaban are limited to a maximum treatment duration of 12 months (hokusai-vte; n engl j med. 2013; 369:1406-15). therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent vte) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 18 months in an unselected patient population in routine clinical practice.

real-world evidence data in routine clinical practice use of edoxaban up to 18 months will be collected in 2,700 patients, treated by specialized as well as non-specialized physicians in hospitals and office based centres in 8 european countries. patients from different countries and care settings (primary care and secondary care, different specialties) will be enrolled in this post-authorization safety study. documentation of baseline and follow up information at 1, 3, 6, 12, and 18 months (only when available) will be collected. in addition, recurrence of symptomatic vte and death will be captured retrospectively at time point of last patient out per country. patients who discontinue permanently edoxaban during the observational period will be followed up according to the same scheme.

Eligibility criteria:
inclusion criteria: * established acute initial or recurrent vte * clinical decision for treatment with edoxaban is made at the time of enrollment * written informed consent for participation in the study (icf) * not simultaneously participating in any interventional study exclusion criteria: * none

Keywords: post-authorisation safety study real world evidence edoxaban efficacy/safety
spine registration using 3d scanning - arise

Conditions: Spinal Fusion; Spondylolisthesis; Scoliosis; Sciatica

Summary: the primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.


Eligibility criteria:
inclusion criteria: 1. patients that require exposure of bony posterior spine anatomy for localization as standard of care. 2. have had a ct scan performed prior to the procedure. 3. clinically planned for spine surgery. 4. able to provide written informed consent from subject, using irb approved consent form, and agrees to comply with protocol requirements. exclusion criteria: 1. language problems that would prevent from properly understanding instructions. 2. patients less than 18 years of age. 3. requirement of an interpreter. 4. patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study. 5. special populations: pregnant women, prisoners. 6. minimally invasive spine surgery that does not expose the necessary bone/s. 7. spine surgery without posterior exposure.
effect of exercise and biofeedback on symptoms of incontinence in women with stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. this study will include women 20 years or older with stress urinary incontinence. the study will involve 2 groups: pelvic floor muscle (pfm) exercises with biofeedback using transabdominal rehabilitative ultrasound imaging (rusi) (group a) and pfm exercises alone (group b). the participants will perform 16 exercise sessions over a period of 8 weeks. group a will perform 3 pelvic floor exercises using the transabdominal rusi to provide biofeedback. group b will perform the same 3 pelvic floor exercises without biofeedback. all participants involved in the study will complete a general medical information questionnaire. in addition, all participants will have their pfm contraction assessed using an ultrasound machine placed over the lower abdomen, quality of life assessed with a written questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at completion of the study.

this study has been terminated.

Eligibility criteria:
inclusion criteria: 1. women will need to be 20 years or older 2. diagnosed with stress urinary incontinence (sui). exclusion criteria: women with: 1. urge or mixed incontinence 2. pelvic organ prolapse 3. previous surgical treatment for incontinence 4. current treatment for sui (including medications) 5. current pregnancy 6. six months or less postpartum 7. body mass index of ≥ 30 8. recurrent vulvovaginitis 9. current/recurrent urinary tract infections (uti) 10. non-english speaking.

Keywords: stress urinary incontinence exercise pelvic floor muscles biofeedback rehabilitative ultrasound imaging
a study of adaptive radiation therapy for pelvic genitourinary cancer

Conditions: Prostate Cancer; Bladder Cancer

Summary: radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. however, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. for prostate cancer patients, the risk is further amplified when pelvic nodes are part of the target irradiated volume. for bladder cancer patients, the risk of injury increases when more of the bladder is part of the target volume. using an adaptive radiation therapy approach allows for correcting any shifts in the target volume. art approach uses images from treatment to adapt the treatment plan. this study will use adaptive radiation therapy for patients who receive pelvic nodal radiotherapy for either prostate or bladder cancer. their treatment plans will adapted using mri scans and cbct scans taken during their first week of radiotherapy to account for any shifts in the target volume. the purpose of this study is to evaluate the feasibility of art approach and its and on treatment plan quality metrics for pelvic radiotherapy. acute and late toxicities will also be evaluated. 40 participants (minimum of 10 bladder cancer patients) will be enrolled. the participants will be followed for a period of 5 years post radiation therapy, during which they will have psa as per standard practice, along with follow-up questionnaires (epic for prostate cancer patients and buss for bladder cancer patients).


Eligibility criteria:
inclusion criteria: 1. histologic diagnosis of adenocarcinoma of the prostate after radical prostatectomy: * clinical stage pt3, pt4, or pt2 with positive margin; or, * any p-stage with persistently elevated post-operative psa \> 0.05ng/ml; or, * a delayed rise in psa post-operative 2. histologic diagnosis of transitional cell carcinoma of the bladder with intact bladder and: * clinical stage ct2, ct3, ct4, and n0 or n1 exclusion criteria: 1. inflammatory bowel disease or other contraindications to radiotherapy. 2. prior pelvic radiotherapy 3. previous cytotoxic chemotherapy 4. evidence of systemic metastases on imaging

Keywords: adaptive radiation therapy