Kornimate/medical-research-clean huggingface dataset:
bevacizumab versus ranibizumab in treatment of macular edema from vein occlusion

Conditions: Retinal Vein Occlusion; Macular Edema

Summary: antagonists of the vascular endothelial growth factor (vegf) pathway are effective in treating macular edema resulting from retinal vein occlusion (rvo). in the eye, the two most widely used anti-vegf agents are ranibizumab and bevacizumab. only ranibizumab has been fda-approved for the treatment of macular edema from rvo, however bevacizumab has been used off-label by many ophthalmologists with good success. furthermore, the cost of bevacizumab is less than one-tenth the cost of ranibizumab. here the investigators conduct a six month randomized, prospective interventional trial comparing the effectiveness of ranibizumab with bevacizumab in the treatment of macular edema from rvo. primary outcome measures are change in central retinal thickness. secondary measures are change in visual acuity from baseline and change in angiographic properties of macular lesions from baseline after treatment.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * visual acuity of 20/40 - 20/320 in the study eye (regardless of relative apd) * central foveal thickness (cft) of \> 250 microns as assessed by oct (see below) * diagnosis of retinal vein occlusion in the past 9 months * age over 50 years exclusion criteria: * history of previous intraocular surgery in the study eye, including pars plana vitrectomy (but not including uncomplicated cataract surgery), within 60 days of the screening visit * inability to make study visits * uncontrolled glaucoma in the study eye (defined as intraocular pressure (iop) ≥ 25 mmhg) despite treatment with two or more topical pharmacological anti-glaucomatous medication) * pregnancy or lactation * evidence of any diabetic retinopathy on exam or history of diabetic macular edema within 12 weeks of study onset * any intravitreal injections within 12 weeks of study onset * prior retinal vein occlusion * history of pan-retinal photocoagulation within 3 months of study onset or anticipated within 4 months after study onset * history of cerebrovascular event or myocardial infarction within 3 months of study onset

Keywords: macular edema vein occlusion bevacizumab ranibizumab vascular endothelial growth factor
enhancing survivorship care planning for patients with localized prostate cancer using a couple-focused web-based tailored symptom self-management program

Conditions: Prostate Cancer

Summary: the purpose of this research study is to examine the feasibility of the enhanced survivorship care plans (escps, regular scps with the a web-based couple-focused symptom self-management project (perc) or national cancer institute prostate cancer web links) and to conduct an initial benefit assessment of enhanced survivorship care plans among prostate cancer patients transitioning from active treatment to post-treatment self-management, and their partners. participation of this study lasts for about for 16 weeks. depending on participants' need for information, it takes 10-30 minutes of their time each week to review the information about prostate cancer. eligible and consented patients with newly treated localized prostate cancer and your partner (couples) are randomly assigned to the regular survivorship care plan (scps) with the nci website or the enhanced survivorship care plans (scp plus the web-based prostate cancer education program, perc) groups. they complete baseline (t1, prior to randomization) and 4-month post-t1 follow-up measures (t2).

methods: a two-group randomized controlled pretest-posttest design will be used and collect data at baseline (t1) and 4 months later (t2) among 50 patients completing initial treatment for localized prostate cancer and their partners. first, the investigators will assess the feasibility of escp by recruitment, enrollment, and retention rates, program satisfaction with the escp, and perceived ease of use of the escp. to achieve the secondary aim, the escp users will be compared with the standardized scp users and assess their primary outcomes of qol (overall, physical, emotional, and social qol), secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms), and number of visits to post-treatment care services at t1 and t2. the primary and secondary outcomes are assessed using measurements with sound psychometrical properties. the investigators will use a qualitative and quantitative mixed methods approach to achieve the research aims. conclusions: the results from this study will help design a definitive randomized trial to test the efficacy of the escps, a potentially scalable program, to enhance supportive care for prostate cancer patients and their families.

Eligibility criteria:
inclusion criteria: eligibility included men who: * were diagnosed with localized pc; * were within 16 weeks of completing their initial curative intent treatment \[26\] at genitourinary and radiation oncology clinics at two comprehensive cancer centers in the u.s southeast; * were not treated for another cancer in last year; and * had a partner \> 18 years of age not receiving cancer treatment. exclusion criteria: * either member of couple unable to speak english * unwilling/unable to provide informed consent

Keywords: survivorship care plan quality of life supportive care
mapping 3d bladder

Conditions: Bladder Cancer

Summary: this is a single centre, single arm feasibility study assessing the feasibility of using computer vision methods to recreate the 3d bladder shape and to then map the cystoscopy images onto this bladder shape. if feasible, this 3d reconstructed shape would be spatially registered to radiological images (ct, mr) that are then used during radiation treatment planning. this analysis would not be used for making any clinical treatment decisions on the patient.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * clinical suspicion or histologic diagnosis of bladder tumour suitable for endoscopic evaluation. * intention to treat using external beam radiation therapy as part of standard of care. * ability to provide written informed consent to participate in the study. exclusion criteria: * prior complete or partial radiation therapy to bladder. * contraindications to radiation therapy as determined by the treating physician. * concurrent illness or condition that precludes subject from undergoing endoscopy or ct scanning.
study of the spermatic characteristics of patients with fabry disease

Conditions: Fabry Disease

Summary: the objective of this project is to estimate the prevalence of spermatic abnormalities in patients with fabry disease.the main objective of this project is to estimate the prevalence of spermatic abnormalities in patients with fabry disease.

fabry disease is a lysosomal storage burden of x-linked genetic transmission due to alpha-galactosidase deficiency. this enzyme deficiency causes deposits of globotriaosylceramide in virtually all cell types of the body. the majority of hemizygous men develop a severe multisystemic disease dominated by renal failure, neurological and cardiac involvement. there is a specific treatment based on enzyme replacement therapy. the incidence of fabry disease is estimated between 1/60000 and 1/3500 in the general population. infertility in fabry disease is poorly documented. only a few cases have been reported, from alteration of spermogram to azoospermia. the identification of deposits suggestive of gb3 in light microscopy and electron microscopy at the level of the genital tract argues in favor of the attack of this device. the low prevalence of fabry disease requires a cross-sectional multicenter study to determine the frequency of alterations in sperm characteristics, their impact on fertility, and the possible effect of substitution therapy, in order to establish appropriate measures. adequate preventive measures. the objective of this project is to estimate the prevalence of spermatic abnormalities in patients with fabry disease.the main objective of this project is to estimate the prevalence of spermatic abnormalities in patients with fabry disease.

Eligibility criteria:
inclusion criteria: * male patients with fabry disease regardless of the clinical form of the disease; treated with enzyme replacement therapy or not (from the initial diagnosis). the definite diagnosis of fabry disease will be established on the deficit of the activity of alpha galactosidase a (\<12%). a molecular genetic study is desirable but not mandatory, * patients aged 18 to 65, * giving their free and informed consent to participate, after information on the research. exclusion criteria: * persons placed under the protection of justice, * unaffiliated or non-beneficiary subject of a social security scheme.
clinical trial of lurbinectedin (pm01183) in platinum resistant ovarian cancer patients

Conditions: Ovarian Cancer

Summary: multicenter, open-label, randomized, controlled phase iii clinical trial to evaluate the activity and safety of pm01183 versus pld or topotecan as control arm in patients with platinum-resistant ovarian cancer. pm01183 will be explored as single agent in the experimental arm (arm a) versus pld or topotecan in the control arm (arm b).


Eligibility criteria:
inclusion criteria: * age \>/= 18 years * confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer. * platinum-resistant disease (pfi: 1-6 months after last platinum-containing chemotherapy). * evaluable disease according to response evaluation criteria in solid tumors (recist) v.1.1 criteria * no more than three prior systemic chemotherapy regimens * eastern cooperative oncology group (ecog) performance status (ps) (ecog ps) ≤ 2 * adequate hematological, renal, metabolic and hepatic function exclusion criteria: * concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major illness * prior treatment with pm01183, trabectedin, or with both pld and topotecan. * requirement of permanent or frequent (i.e., once per week) external drainages within two weeks prior to randomization
virtual empowered relief for chronic pain

Conditions: Chronic Pain; Pain

Summary: the purpose of the current pilot study is to examine a feasibility and the preliminary efficacy of empowered relief (er) class when it is delivered 'virtually' to patients with chronic pain who take methadone or buprenorphine. the er class is a single-session pain management class, which has demonstrated to be effective in improving pain and pain-related distress in patients with chronic low back pain, but its efficacy has not been examined in patients with chronic pain who take methadone or buprenorphine. class participants will learn self-regulatory skills and develop a personalized plan to use the skills every day. the current study will examine a feasibility and participant's perception and satisfaction of this class at post-class. the study will also follow participants 3 months by administering 5 surveys (baseline, 2 weeks and 1 month, 2 months, and 3 months post-treatment) to determine whether the class confers the short-term and medium-term benefits across various aspects of health.

some patients with chronic pain are on long-term opioid therapy. methadone and buprenorphine are often used in long-term opioid therapy for chronic pain. additionally, chronic pain is highly prevalent in people receiving methadone or buprenorphine for opioid use disorder (moud). it is observed that up to 68% of people with moud have chronic pain condition. therefore, a large number of people taking methadone or buprenorphine will suffer from chronic pain, but they frequently face limited availability of clinicians offering non-pharmacological pain management programs. thus, a brief internet-based pain relief skills program may be one option that can overcome such treatment barrier. a recent randomized control trial on patients with chronic low back pain has demonstrated that a single-session, 2-hour, pain management class (empowered relief; er) was effective to improve pain and pain-related distress. the er class consists of pain neuroscience education and self-regulatory skills. while the er is a promising and scalable option, it is not yet tested in patients with chronic pain who take methadone or buprenorphine. the current proposed, single-arm, uncontrolled pilot project will determine a) a feasibility in this patient population, b) patients' perceptions and satisfaction of the er class and c) preliminary efficacy to inform the design of a future, larger, controlled trial.

Eligibility criteria:
inclusion criteria: * age at least 18 years old * chronic pain (\> 3 months) * taking methadone or buprenorphine * english fluency exclusion criteria: * pregnant, * gross cognitive impairment, * acute suicidality, * severe depression
reducing micro vascular dysfunction in acute myocardial infarction by ticagrelor

Conditions: Myocardial Infarction

Summary: the current trial will compare the protective effect of ticagrelor and prasugrel on microvascular dysfunction in patients with revascularized st elevation myocardial infarction.

coronary microvascular dysfunction is highly prevalent in revascularized st-elevation myocardial infarction and has important prognostic implications. current data suggest that ticagrelor might be superior to prasugrel in the reduction of coronary microvasculature dysfunction. thus, we have designed a clinical trial that will compare microvascular function in revascularized st-elevation myocardial infarction patients at treatment steady state with ticagrelor or prasugrel. coronary microvascular dysfunction will be assessed with the index of microcirculatory resistance after primary percutaneous coronary intervention and at 1 month follow-up in the infarct-related vessel and non-infarct related vessel.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent 2. patients presenting with st-elevation myocardial infarction \<12 hours after symptom onset 3. successful percutaneous coronary intervention of the infarct-related vessel with a modern drug-eluting stent 4. intermediate stenosis in non-infarct-related vessel (50-90%) exclusion criteria: 1. history of myocardial infarction 2. participation in another clinical study with an investigational product during the preceding 30 days 3. history of cerebrovascular accident (cva) or 'transient ischaemic attack' (tia) 4. history of intracranial haemorrhage 5. indication or use of oral anticoagulant therapy (i.e. acenocoumarol) 6. severe liver dysfunction (child-pugh score 10-15) 7. congestive heart failure 8. cardiogenic shock 9. left ventricular ejection fraction \< 35% 10. bleeding diathesis 11. age ≥ 75 or \< 18 12. body weight \< 60 kg 13. gout 14. coagulation disorders 15. severe pulmonary disease 16. pregnancy and breast feeding 17. limited life expectancy 18. platelet count \< 100 000/mm3 19. history of drug addiction or alcohol abuse in the past 2 years 20. need for chronic nonsteroidal anti-inflammatory drug 21. creatinine clearance \<30 ml/min or dialysis 22. chronic total occlusion (cto) 23. left main disease 24. allergy or contra-indication for ticagrelor or prasugrel 25. contra-indication for adenosine 26. patients unable to be followed on-site 27. unable to undergo or contra-indications for mri 28. contra-indication for drug-eluting stent 29. inability to obtain informed consent 30. coronary artery bypass grafting in medical history

Keywords: st elevation myocardial infarction percutaneous coronary intervention endothelial function ticagrelor prasugrel
rosuvastatin for preventing deep vein thrombosis

Conditions: Deep Vein Thrombosis; Venous; Thrombosis; Prevention

Summary: deep vein thrombosis (dvt)is devastating disease which influencing the mortality and morbidity of patients at-risk like those undergoing orthopedic surgery. recent publication suggested hmo-co-a reductase inhibitor (statin) may reduce the occurrence rate of venous thromboembolism in apparently healthy persons. the pleiotropic property of statin like antioxidant, antithrombotic, anti-inflammatory may have effect on the positive results. we are investigating whether rosuvastatin is associated with lower incidence of deep vein thrombosis (dvt) in patients undergoing total knee replacement arthroplasty(tkra)who are at-high risk for developing dvt


Eligibility criteria:
inclusion criteria: * patients who are going to receive total knee replacement arthroplasty from any cause. * \< 19 years old exclusion criteria: * patients with cancer * patients receiving anticoagulant agents from any cause * current statin users * expecting survival from other co-morbidity \< 1year * bed ridden patient * ast, alt \> 3times of upper normal limit * ck\> upper normal limit * pregnancy * patients who receives hormone replacement therapy

Keywords: thrombosis vein statin prevention
a fluorescent tumor marking agent, tozuleristide, for imaging oral cavity squamous cell cancer and high-grade oral cavity dysplasia during surgery

Conditions: Oral Cavity Squamous Cell Carcinoma; Stage I Lip and Oral Cavity Cancer AJCC v8; Stage II Lip and Oral Cavity Cancer AJCC v8; Stage III Lip and Oral Cavity Cancer AJCC v8; Stage IVA Lip and Oral Cavity Cancer AJCC v8

Summary: this phase i/ii trial studies the side effects of tozuleristide in imaging oral cavity squamous cell cancer and high-grade oral cavity dysplasia during surgery. tozuleristide is an imaging agent that specifically binds to tumor cells. when exposed to near-infrared light, tozuleristide causes tumor cells to fluoresce (light up), so that surgeons may better distinguish tumor cells from healthy cells during surgery.

outline: beginning 1 hour before surgery, patients receive tozuleristide intravenously (iv) over 1-5 minutes. patients then surgical resection per standard of care and undergo near infrared (nir) imaging with standard of care device.

Eligibility criteria:
inclusion criteria: * adult subjects age \>= 18 years (yr) * subjects must have suspected or confirmed oral cavity dysplasia or ct1-4 squamous cell carcinoma for which surgical excision is deemed clinically indicated by the treating physician. histology confirmation not required prior to surgery * able to provide written informed consent * if of child-bearing potential, agree to the continued use of 2 reliable forms of contraception from study enrollment through 30 days after receiving the study product. male subjects must agree to use 2 reliable methods of contraception simultaneously for 30 days after receiving the study product if their partner is of child-bearing potential * available for all study visits and able to comply with all study requirements exclusion criteria: * known or suspected sensitivity to indocyanine green * in the opinion of the treating physician, subject has received photosensitizing medication that could interfere or confound study results * any current medications with the potential to generate fluorescence or photochemical reaction * enrolled in any other ongoing study * currently lactating or breastfeeding * positive pregnancy test or planning to become pregnant within 30 days (d) of receiving tozuleristide * any current condition, including psychological and social situations which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data * creatinine clearance \< 60 ml/min * aspartate aminotransferase (ast) \> 1.5 x upper limit of normal (uln) * alanine aminotransferase (alt) \> 1.5 x uln * bilirubin \> 1.5 x uln
study evaluating prevenar in the prevention of invasive pneumococcal disease (ipd) in the paediatric population in spain.

Conditions: Invasive Pneumococcal Disease

Summary: the aim of this study is to evaluate the postlicensure effectiveness of prevnar in the prevention of ipd in the spanish paediatric population (children younger than 5 years)


Eligibility criteria:
inclusion criteria: * all children from 0 up to 5 years attending to the hospital's emergency department will be evaluated for ipd. * diagnosis of ipd will be based on positive pneumococcal isolation in any sterile location, such us blood or spinal fluid.
clinical study of new urine collection bag for infants.

Conditions: Urinary Tract Infection

Summary: to determine whether a new urine collection bag for infants produces a reliable urine sample for culturing in respect of contamination rate with skin bacteria.


Eligibility criteria:
inclusion criteria: * healthy children. exclusion criteria: * current infection of any kind. history of urinary tract infection.
short term refractive and ocular parameter changes after topical atropine

Conditions: Myopia, Left Eye

Summary: in order we had designed a prospective clinical trial. spherical equivalent refractive error (ser), axial length (al), mean keratometric value (mean-k), anterior chamber depth (acd), and intraocular pressure (iop) were measured at baseline and one week after topical use of 0.125% atropine. postcycloplegic changes of refractive error and ocular parameters were evaluated, and their correlations were analyzed with multiple linear regression models.


Eligibility criteria:
inclusion criteria: * patients who had an ser of -0.5 diopters or less in their eyes. exclusion criteria: * patients who had already been undergoing cycloplegic treatment for myopia before.

Keywords: atropine cycloplegia refraction axial length anterior chamber depth
mre evaluation of liver stiffness after tricuspid valvular repair

Conditions: Tricuspid Valve Insufficiency

Summary: the purpose of this study is to look at liver stiffness with a mri sequence called magnetic resonance elastography (mre). the study will let the investigators know whether the subject's liver is normal or has increased stiffness. increased liver stiffness often means there is chronic liver disease and fibrosis. increased right heart pressure and congestive heart failure are considered risk factors for development of liver fibrosis. liver fibrosis, if progressive, may lead to cirrhosis and its related complications. the increased liver stiffness may be due to a poorly functioning tricuspid valve. with this research, the investigators will be able to determine if the elevated stiffness of the liver returns to normal after the surgeon performs a repair or replacement of the tricuspid valve.


Eligibility criteria:
inclusion criteria: * primary tricuspid valvular regurgitation (tricuspid valve disease not related to a left-sided cardiac abnormality) diagnosed by echocardiography * evidence of passive hepatic congestion. patients with severe tricuspid regurgitation diagnosed at echocardiography will constitute evidence of passive hepatic congestion. * patient scheduled for surgical tricuspid valvular repair or replacement. exclusion criteria: * contraindication for mri (implantable devices such as cardiac pacemaker, anxiety, inability to lay supine, etc). * additional conditions which may elevate their liver stiffness: hepatic fibrosis or cirrhosis, hepatic parenchymal disease (primary biliary cirrhosis, primary sclerosing cholangitis, etc), acute or chronic hepatitis (viral, substance or medication induced), disorders of hepatic vasculature, biliary obstruction or disease, primary or metastatic hepatic malignancy. * cannot agree to return for a follow up visit to complete the postsurgical imaging.