Kornimate/medical-research-clean huggingface dataset:
ranibizumab in combination with proton beam irradiation for choroidal melanoma

Conditions: Choroidal Melanoma

Summary: the purpose of the study is to investigate the safety and tolerability of the anti-vegf (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. systemic adverse events will also be evaluated. a secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed choroidal melanoma undergoing proton therapy * tumors \>15 mm in largest diameter and/or \>5 mm in height * tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye exclusion criteria: * history of prior treatment for choroidal melanoma * pregnancy or lactation * presence of diabetic retinopathy * history of retinal vascular occlusion or other retinal vascular disease * active ocular inflammation or history of uveitis in either eye * history of uncontrolled glaucoma (defined as intraocular pressure \>30mmhg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye * previous intravitreal injections of avastin® in the study eye or in the non-study eye within 30 days. * concurrent use of systemic anti-vegf therapy

Keywords: glaucoma, neovascular macular edema eye enucleation antibodies, monoclonal radiation oncology
aquatic exercise and stroke

Conditions: Stroke

Summary: to determine the impact of underwater vs. land based exercise and/or gait training on functional mobility for patients with stroke.

subjects will be recruited via convenience sampling from the methodist university community and local area. additionally contacts from medical clinics may be contacted for recruitment of participants. once individuals have been identified, they will be informed of inclusion and exclusion criteria to be assessed for appropriateness for the project. informed consent will be provided to participants prior to start. inclusion criteria consists of having a stroke and being able to walk 20 meters without a lower extremity orthotic. if participant's have significant fear of water, seizures, incontinence with bowel or bladder, open wounds, infections such as uti or fever, tracheostomy, nasogastric or gastronomy tube, colostomy, uncontrolled hypertension, skin rash, hard cast due to fracture, isolation precautions, iv or indwelling catheters, uncontrolled agitation, require use of continuous supplemental oxygen, or allergies to chemicals used in a pool, they will not be placed in the underwater groups. demographic survey will be provided and filled out prior to the start of data collection. as physical therapy exercise is within the scope of physical therapy practice and in the state of north carolina physical therapists have direct access to practice without a physician clearance, participants will be assessed using baseline testing (please see below) to ensure medical stability for participation in exercise. furthermore, participants will be asked if they have been cleared by a physician prior to beginning in exercise (please see consent survey). if individuals evaluated by the supervising physical therapist are deemed to need additional medical clearance from their physician, they will be asked to attain a note from the physician stating they are clear to participate in exercise. baseline testing: participants will complete a basic physical therapy examination consisting of vitals assessment (heart rate, blood pressure, oxygen saturation, rate of perceived exertion and respiratory rate), anthropometric measurements, posture, range of motion, strength testing and use of the following outcome measures to assess self-perception of stroke impact, balance and gait: 4-square step test (fsst), timed up and go (tug), dynamic gait index (dgi), romberg, sharpened romberg and single limb stance (sls). additionally, gait characteristics will be measured using the gaitrite system.

Eligibility criteria:
inclusion criteria: * stroke * able to walk 20 meters without a lower extremity orthotic. exclusion criteria: * significant fear of water * seizures * incontinence with bowel or bladder * open wounds * infections such as uti or fever * tracheostomy, nasogastric or gastronomy tube * colostomy * uncontrolled hypertension * skin rash * hard cast due to fracture * isolation precautions * iv or indwelling catheters * uncontrolled agitation * require use of continuous supplemental oxygen * allergies to chemicals used in a pool
clinical validation study for optimization of anemia management in hemodialysis patients with end stage kidney disease using the dialysis anemia treatment model

Conditions: Dialysis

Summary: this is a human subject research study conducted in patients undergoing dialysis treatment with darbepoetin alfa at intermountain utah dialysis and intermountain medical center dialysis services. the purpose is to test a dose recommendation algorithm that may reduce hemoglobin variability and drug cost.

hemoglobin cycling is an outcome of treating long-term dialysis patients for anemia using erythropoiesis-stimulating agents (esas), and represents a conundrum for practitioners. while patients with low hemoglobin levels suffer from anemia, high hemoglobin levels may lead to blood clots and subsequent health risks. the current protocol for esa dosing often results in suboptimal dosing that leads to hemoglobin cycling, which can have a negative impact on patient survival. to this end, we have developed a personalized method for esa dosing that controls anemia in dialysis patients that is similar to the commercial product sold by physoft. our method, the dialysis anemia treatment model, uses a mathematical model for erythropoiesis that takes each patient's physiology into account, predicting the optimal dose of esa for that patient to prevent hemoglobin cycling. the goal of this computer-aided approach is to reduce hemoglobin cycling and the amount of drug used by predicting optimal doses to keep the patient's hemoglobin within the desired range. this is a human subject research study to validate the model in the clinic and demonstrate that it is able to minimize hemoglobin cycling in patients and reduce the amount of esa drug administered.

Eligibility criteria:
inclusion criteria: * males and females (≥ 18 years of age) with end stage kidney disease undergoing in-center hemodialysis * 150 days of hemoglobin readings and aranesp doses without a hospitalization relevant to the condition of anemia exclusion criteria: * inflammation as characterized by ferritin levels greater than 1000 ng/ml * patients with active cancer * patients with pth greater than 1,000 pg/ml * active gi bleed * hospitalization relevant to esrd in last 150 days or during study * patients receiving procrit rather than aranesp.

Keywords: darbepoetin kidney dialysis hemoglobin cycling
wellness education intervention

Conditions: Overweight and Obesity; Eating Disorders; Depression, Anxiety

Summary: individuals suffering from depression and anxiety have an increased risk of obesity due to multiple factors such as side effects to psychotropic medications, associated appetite dysregulation, disruption of sleep, anergia leading to psychomotor retardation or inactivity, and increased stress hormones through the disruption in the hypothalamic-pituitary-adrenal (hpa) axis. though not a causal relationship, an intimate bidirectional connection exists between the two conditions, which subsequently impacts the journey of weight loss. the impact mental health can have on weight loss is evident as concurrent depression and anxiety in individuals with obesity predicts poorer outcomes like decreased adherence and less success with weight loss interventions. here, we will determine if delivery of psychoeducation regarding the primitive brain and model of safety in a group setting to those with obesity seeking weight loss intervention has an impact on not only psychiatric symptoms of depression and anxiety but also weight loss, eating behaviors, sleeping patterns, activity level, and health-related quality of life. this project will improve our understanding of the role of mental health and the stress response in obesity.

this project will recruit subjects seeking weight loss in the dallas fort worth area. a screen consisting of patient's weight and height to calculate a patient's bmi will be completed. pre-assessment measures of anxiety, depression, eating disorder symptoms, sleep, self-efficacy, quality of life, and weight-wellness related behaviors (sleeping patterns, exercise patterns, eating patterns) will be completed before the intervention using a secure online link to redcap. participants will then attend eight weekly sessions of a group psychoeducational intervention. the intervention includes eight modules of various topics including the psychoeducation on the primitive brain model, motivation, goal-setting, affirmations, rewards, promoting autonomy, reducing guilt, and relapse prevention. participants will complete homework assignments, share their work with the group to elicit feedback, and participate in guided discussions. post-assessments will be completed 1-4 weeks and 3-5 months after the interventions is completed. these measures will determine (1) if psychological symptoms are responsive to the intervention, and (2) if clinical symptom changes related to weight and quality of life are affected.

Eligibility criteria:
inclusion criteria: * able to give informed consent * able to speak english sufficiently to understand study procedures, provide written informed consent for study participation, and complete questionnaires * bmi \> 25 * appropriate for outpatient care exclusion criteria: * medically unstable * inpatient medical * psychiatric inpatient * psychiatric residential care
study of travoprost ophthalmic solution, 0.004% compared to timolol (0.5% or 0.25%) in pediatric glaucoma patients

Conditions: Pediatric Glaucoma; Elevated IOP in Pediatric Patients; Ocular Hypertension in Pediatric Patients

Summary: the purpose of this study is to evaluate the intraocular pressure (iop)-lowering efficacy of travoprost 0.004% polyquad (pq) ophthalmic solution compared to timolol ophthalmic solution (0.5% or 0.25%) in pediatric glaucoma patients.


Eligibility criteria:
inclusion criteria: * diagnosis of pediatric glaucoma or ocular hypertension. * qualifying mean iop at the eligibility visit in at least one eye. * written informed consent, including assent when applicable, must be obtained from the parent or legally authorized representative prior to any procedure specified in the protocol, including screening procedures. * other protocol-defined inclusion criteria may apply. exclusion criteria: * females of childbearing potential who are pregnant, intend to become pregnant during the study period, breast feeding, or not using any form of birth control measures. * history of chronic, recurrent or severe inflammatory eye disease. * ocular trauma requiring medical attention within the past 3 months prior to the screening visit. * ocular infection or ocular inflammation within the past 30 days prior to the screening visit. * clinically significant or progressive retinal disease. * severe ocular pathology (including severe dry eye) that, in the opinion of the investigator, would preclude the administration of a topical prostaglandin analog or a topical beta-blocker. * intraocular surgery in the study eye within 30 days prior to the screening visit. * any abnormality preventing reliable applanation tonometry. * other protocol-defined exclusion criteria may apply.
cost effectiveness of nonoperative management for adult spinal deformity

Conditions: Spinal Deformity

Summary: quantify the efficacy and cost of nonoperative treatment modalities used for adult spinal deformity.

1. identify disease burden associated with adult spinal deformity (asd) using quality adjusted life year (qaly) analysis. 2. identify disease burden of specific demographic and radiographic features associated with asd. 3. compare disease burden of asd to other musculoskeletal and non-musculoskeletal diseases. 4. identify efficacy of specific nonoperative treatment modalities to treat asd and identify specific clinical and radiographic features of asd responsive to nonoperative treatment modalities. 5. compare qaly and icer values for different asd nonoperative treatment modalities to previously established qaly and icer for values for operative and nonoperative treatment modalities for degenerative hip and knee disease, coronary artery disease, insulin dependent diabetes, and hypertension. 6. evaluate the cost and work hours associated with data collection and minimum 85% patient follow up. 7. evaluate patient characteristics associated with poor patient compliance for study follow up including demographic, radiographic and hrqol values and for reasons for cross-over to operative treatment for asd. 8. establish standardized data collection methodology for economic based outcome studies based upon patient demographics and hrqol values.

Eligibility criteria:
inclusion criteria: 1. age 40-75 years of age at the time of enrollment. 2. odi ≥30 3. adult degenerative or idiopathic lumbar scoliosis 10-40° as measured by the cobb angle technique 4. sagittal plane deformity by srs schwab classification with at least one modifier ++ or two modifiers + and associated coronal cobb of at least 10 degrees exclusion criteria: 1. adult degenerative or idiopathic scoliosis with a curvature of the spine measuring \ 40 degrees 2. diagnosis of scoliosis other than degenerative or idiopathic (i.e. neuromuscular, congenital, etc.) 3. cardiopulmonary disease or comorbidities that preclude surgical intervention 4. patient not deemed surgical candidate by treating surgeon 5. patient unwilling to commit to monthly phone interviews or completion of necessary questionnaires or inability to return for defined follow up time points. patients unwilling to comply with study protocol will not be offered enrollment into the study, regardless of meeting inclusion criteria.

Keywords: scoliosis kyphosis sagittal plane deformity
study of biomarkers of heat tolerance and recovery during ultra-endurance exercise

Conditions: Heat Stress; Heat

Summary: military personnel are called upon to serve in hot, dry or humid climates, which places great demands on their ability to tolerate heat. induced heat stress can impair performance and lead to pathologies. faced with the challenges of global warming, this issue is becoming increasingly important in the practice of sport. while hyperthermia is known to impair endurance performance, the underlying thermophysiological responses and regulatory mechanisms during prolonged exercise remain poorly understood. the effects of hyperthermia on mental performance raise questions about the degradation of interoceptive capacities and the deleterious impact on behavioral regulation, an important component of thermal risk management in ultra-endurance exercise. what's more, despite the muscular and hydromineral consequences (rhabdomyolysis, renal failure, dehydration) of prolonged exercise, few data are available on recovery kinetics. a better understanding of the factors conditioning recovery quality could help limit the deleterious consequences of ultra-endurance exercise.


Eligibility criteria:
inclusion criteria: * healthy individuals * bmi between 18 and 25 kg/m2 * weight ≥ 51 kg * minimum training volume 6 days/7, aerobic * participation in a running competition ≥ 6hours * having given informed consent exclusion criteria: * presence or history of medical pathology * presence of significant deviation from normal electrocardiogram values * history of heat stroke * known intolerance to heat * inability to swallow a capsule or refusal of rectal probe * alcohol consumption exceeding the equivalent of 3 glasses of wine per week * consumption of narcotics * smoking \> 0.5 pack of cigarettes per day * on usual medication * pregnant or breast-feeding women * protected adult, under legal protection, guardianship or curatorship, or unable to give personal written consent

Keywords: ultra-endurance
an exploratory study of ganglioside gm1 in acute ischemic stroke

Conditions: Stroke, Ischemic

Summary: the purpose of this study was to evaluate the efficacy and safety of higher doses of monosialoganglioside gm1 injection in the treatment of patients with acute ischemic stroke.


Eligibility criteria:
inclusion criteria: * 1. age: 18-80 years old； * 2. patients with anterior circulation cerebral infarction; * 3. first stroke onset or past stroke without obvious neurological deficit (mrs score≤1)； * 4. within 24 hours of onset； * 5. 5 ≤nihss score ≤ 20； * 6. signed informed consent. exclusion criteria: * 1. patients with hereditary abnormal glucose and lipid metabolism (gangliosidosis, such as tay-sachs disease and retinal degeneration); * 2. hemorrhagic stroke; * 3. disturbance of consciousness (nihss1a≥1)，or cerebral arteritis, brain tumor, brain trauma, intracranial infectious diseases; * 4. planed endovascular treatment; * 5. uncontrolled hypertension: systolic pressure ≥200 mmhg or diastolic pressure ≥110 mmhg; * 6. bleeding tendency (except for thrombolysis) or severe bleeding within 3 months; * 7. patients with malignant tumor or serious diseases; * 8. along with epilepsy, arthritis and other disease, which have effect on neurological assessment; * 9. history of autoimmune diseases, spinal trauma, various demyelinating diseases, including acute inflammatory demyelinating polyneuropathy (guillain barre syndrome); * 10. unable or unwilling to cooperate due to mental diseases; * 11. abnormal liver and renal function: alt, ast \> 2 times of the upper limit of normal value, or cr \> 1.5 times of the upper limit of normal value； * 12. hypersensitivity to monosialoganglioside and excipients of test drug; * 13. history of drug abuse； * 14. pregnant or lactating women, pregnant plan or unwilling to use effective contraception during the trial period; * 15. participating in other clinical trials within 3 months; * 16. other conditions which are unsuitable for this trial assessed by researcher.

Keywords: monosialoganglioside gm1 ischemic stroke
cross-linking of corneal collagen (cxl) with ultraviolet-a in asymmetric corneas

Conditions: Keratoconus; Ectasia; Degeneration

Summary: the purpose of this study is to evaluate the efficacy of ultraviolet-a (uva)-induced cross-linking of corneal collagen (cxl) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using uva light and the photo- mediator riboflavin. the purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. the data generated by this study will not be submitted to the fda to support commercialization of these riboflavin drops.


Eligibility criteria:
inclusion criteria: * 12 years of age or older * diagnosis of keratoconus, ffkc, post-lasik ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (ffpmd). * diagnosis of ffkc * history of radial keratotomy with fluctuating vision * ability to provide written informed consent * likely to complete all study visits * minimum corneal thickness of at least 300 measured by ultrasound or pentacam * at least 6 months since last corneal surgery (intacs/prk/lasik/epi-lasik/lasek) exclusion criteria: * severe corneal scarring that markedly affects vision * contraindications to any study medications or their components * pregnancy or breast feeding * active herpes corneal disease
efficacy and safety of ozenoxacin 1% cream versus placebo in the treatment of patients with impetigo

Conditions: Impetigo

Summary: this is multicenter, randomised, placebo controlled, parallel, double blinded , superiority clinical study comparing ozenoxacin cream versus placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of bullous or non bullous impetigo. the patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. in case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. additionally for patients \< 12 years the total area will not exceed a maximum of 2% of the body surface area. * total skin infection rating scale (sirs) score of at least 3, including pus/exudate score of at least 1 exclusion criteria: * has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic. * has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °c (99.0 °f)
the impact of chronic adolescent skin conditions on sexual health

Conditions: Psychological; Sexual Dysfunction; Adolescent Development; Interaction, Social; Dermatologic Disease

Summary: background: skin conditions are common in young people and are known to adversely affect emotional well-being and quality of life in a range of ways, including negative impact on intimate relationships. however, despite its importance, it has been shown that dermatology consultations rarely address issues like genital skin involvement or sexual dysfunction. furthermore, there is currently very little data on the scale of the problem, risk factors, psychological impact of skin on sexual function or understanding of the most appropriate ways to manage it in this age group. research aims: the dermatology department at oxford university hospitals national health service trust (oxford, united kingdom) have already set up an award-winning specialist dermatology service for young people with embedded psychological support. this study further explores how services can be improved by evaluating the impact of chronic skin conditions on quality of life and sexual dysfunction in adolescents. by identifying the associated risk factors, recommendations can be made to effectively meet the physical and mental health needs of adolescents. design and methods: the study will gain perspectives from follow-up patients aged 17 - 25 years seen by the dermatology departments in oxford university hospitals national health service trust (oxford, united kingdom). they will complete an online anonymous survey to share how their skin condition affects their quality of life, including sex and intimacy, and how services can be improved to meet their needs. in-depth interviews will then be conducted in those who volunteer, to better understand the nuances of unmet needs. participation is voluntary. dissemination: results of the research will be disseminated by national and international conferences, publications in academic dermatology journals and collaborations with other nhs departments. improvements will be made to the local adolescent dermatology service as a result and shared via local meetings and posters.


Eligibility criteria:
inclusion criteria: * the participant is willing and able to give informed consent for participation in the study. * male or female, aged 17-25 (inclusive). * diagnosed with a long-term skin condition and seen as a follow-up patient in the clinic. * recruited from paediatric/adolescent, general and acne clinics under the oxford university hospitals national health service trust dermatology department. * fluent in english (reading and writing). exclusion criteria: * no informed consent was given to participate in the study or use the data for research purposes. * no capacity to make an informed decision to consent.