Kornimate/medical-research-clean huggingface dataset:
outcomes of vitrectomy in pediatric retinal detachment with proliferative vitreoretinopathy

Conditions: Pediatric Rhegmatogenous Retinal Detachment

Summary: the aim of this study is to report outcomes of pars plana vitrectomy (ppv) in pediatric retinal detachment (rd) accompanied with proliferative vitreoretinopathy (pvr) as well as complications and factors influencing the final anatomical and functional results. this is retrospective consecutive case series of 14 eyes treated with primary ppv for rd repair. average postoperative follow-up period is 34 months.

this is the retrospective study of 14 consecutive patients younger than 18 years age who underwent primary ppv at the department of general ophthalmology of medical university of lublin in a time period from 1st january 2006 to 1st january 2017. this study followed the tenets of the declaration of helsinki. the treatment chosen in the study was a part of a standard care. written informed consent was taken from all subjects. all patients underwent vitreoretinal surgery due to rd (rhegmatogenous, tractional or combined rhegmatogenous and tractional). exclusion criteria from the study was the time of follow-up less than 6 months. average age at the time of the presence of rd was 10±4.7 years (range 4-17 years). pre- and postoperative data were collected. descriptive statistical analysis included gender, age at the presentation, laterality, etiology, duration of presenting symptoms, presences of ocular comorbidities, macular status (attached or non-attached), presence of pvr grade c, initial and final best-corrected visual acuity (bcva), number of procedures, type of endotamponade during ppv, final lens status, duration of the follow-up, anatomical success and complications. indications for ppv were as follows: presence of advanced pvr and/or total rd and/or multiple breaks, giant retinal tears. pvr was graded according to the retina society terminology classification \[9\]. visual acuity was measured by snellen charts. the anatomical success was defined as persistent retinal reattachment at the last follow-up visit (regardless of presence or absence of silicone oil tamponade). statistical computations were performed using statistica 13pl (stasoft, usa) programme.

Eligibility criteria:
inclusion criteria: * patients younger than 18 years age who underwent primary ppv at the department of general ophthalmology of medical university of lublin in a time period from 1st january 2006 to 1st january 2017 exclusion criteria: * age up to 18 years old
a study to investigate the possible causes of secondary effects during use of peripheral midline type catheter in patients hospitalized in different care settings

Conditions: Upper Extremity Deep Vein Thrombosis, Secondary

Summary: although the use of peripheral venous catheters (cvp) with brachial insertion with echo-guide (midline) has increased significantly over the last 5-10 years, there are no sensitive data concerning complications in the literature during their use, particularly as regards incidence of thrombotic complication.the prospective observational study will enroll all the patients admitted to home health hospitalization service, geriatric department and intermediate care service, to whom a midline-type cvp will be placed for infusional therapy and who will give their consent to participate.


Eligibility criteria:
inclusion criteria: * subjects admitted to wards adhering to the study (home health hospitalization service, geriatric department and intermediate care service) * subjects submitted to midline type venous catheter insertion exclusion criteria: * history of deep venous thrombosis or pulmonary embolism * be hospitalized for less than a week

Keywords: midline peripheral venous catheter vascular access device deep venous thrombosis
open label extension trial of pde4 inhibition with roflumilast for the management of atopic dermatitis

Conditions: Atopic Dermatitis Eczema

Summary: this study will assess the safety and efficacy of arq-151 cream applied once a day for 52 weeks by subjects with atopic dermatitis (eczema).

this is an open-label study in which arq-151 cream is applied once daily x 52 weeks to subjects with atopic dermatitis (eczema).

Eligibility criteria:
inclusion criteria: 1. for adult subjects: participants legally competent to sign and give informed consent. for pediatric and adolescent subjects: informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws. 2. males and females, ages 2 years and older. (only subjects 18 years and older will be enrolled at sites located in the province of québec in canada.) 3. subjects with atopic dermatitis who met eligibility criteria for and successfully completed one of three preceding studies through week 4, and are able and eligible to enroll into this long-term safety study on the week 4 visit of the preceding study. 4. females of childbearing potential (focbp) must have a negative urine pregnancy test at all study visits. in addition, sexually active focbp must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial. 5. females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with fsh testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). 6. subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the protocol and visit schedule, according to the judgment of the investigator. exclusion criteria: 1. subjects who experienced a treatment-related ae or a serious ae (sae) that precluded further treatment with arq-151 cream in the preceding study. 2. subjects that use any excluded medications and treatments. 3. subjects with skin conditions other than ad that would interfere with evaluations of the effect of the study medication on ad, as determined by the investigator. subjects with any condition on the treatment area which, in the opinion of the investigator, could confound efficacy measurements. 4. subjects with known genetic dermatological conditions that overlap with ad. 5. females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. 6. subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), or who display another condition, which in the investigator's opinion, makes them unsuitable for clinical study participation. 7. subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects (subjects enrolled in other studies of arq-151 cream) living in the same house.
analyzing clinical trial experiences of colon cancer patients

Conditions: Colon Cancer; Colon Disease

Summary: participation in medical trials usually favors a particular demographic group. but there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. this trial will admit a wide range of data on the clinical trial experience of colon cancer patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. it will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future colon cancer patients.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with colon cancer * patient has self-identified as planning to enroll in an observational clinical trial * patient is a minimum of 18 years or older exclusion criteria: * pregnant or nursing patients * inability to perform regular electronic reporting * patient does not understand, sign, and return consent form

Keywords: colon cancer colon disease
a 6 month study of once daily ciclesonide hydrofluoroalkane (hfa) nasal aerosol in the treatment of perennial allergic rhinitis (par) in subjects 12 years and older

Conditions: Perennial Allergic Rhinitis

Summary: 6-month safety extension study in subjects who have completed study 060-633 (nct00953147). evaluating the long-term safety of ciclesonide hfa nasal aerosol 160 μg administered once-daily in patients with perennial allergic rhinitis.

this is a 6-month multi-center, open-label, long-term safety extension study in subjects who have completed study 060-633 (nct00953147). this study is designed to evaluate the long-term safety of ciclesonide hfa nasal aerosol 160 μg administered once-daily to male and female subjects 12 years or older diagnosed with perennial allergic rhinitis (par). this study was previously posted by sepracor inc. in october 2009, sepracor inc. was acquired by dainippon sumitomo pharma., and in october 2010, sepracor inc's name was changed to sunovion pharmaceuticals inc.

Eligibility criteria:
inclusion criteria: * subject has successfully completed all visits of study 060-633. * subject has given written informed consent and assent, including privacy authorization as well as adherence to concomitant medication withholding periods, prior to participation. * subject is male or female 12 years and older. * subject must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on screening physical examination, clinical laboratory tests, and medical history. * subject, if female 65 years of age or younger, must have a negative urine pregnancy test (performed at visit 1). females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: 1. an oral contraceptive, an intrauterine device (iud), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation. 2. barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study. 3. abstinence. exclusion criteria: * female subject who is pregnant or lactating. * history of physical findings of nasal pathology, including nasal polyps. * subject has any condition that, in the judgment of the investigator, would preclude the subject from completing the study.

Keywords: perennial allergic rhinitis allergic rhinitis ciclesonide
risk prediction models for adverse maternal and neonatal outcomes in preeclampsia

Conditions: Severe Preeclampsia

Summary: this proposal describes a single centre retrospective cross-sectional study which will address the need to further develop and test statistical risk prediction models for adverse maternal and neonatal outcomes in low-resource settings; this will be the first such research to be carried out in zimbabwe.

hypertensive disorders in pregnancy are a leading cause of maternal and perinatal morbidity and mortality, especially in low-resource settings. identifying mothers and babies at greatest risk of complications would enable intervention to be targeted to those most likely to benefit from them. however, current risk prediction models have a wide range of sensitivity (42-81%) and specificity (87-92%) indicating that improvements are needed. furthermore, no predictive models have been developed or evaluated in zimbabwe. this proposal describes a single centre retrospective cross-sectional study which will address the need to further develop and test statistical risk prediction models for adverse maternal and neonatal outcomes in low-resource settings; this will be the first such research to be carried out in zimbabwe. data will be collected on maternal demographics characteristics, outcome of prior pregnancies, past medical history, symptoms and signs on admission, results of biochemical and haematological investigations. adverse outcome will be defined as a composite of maternal morbidity and mortality and perinatal morbidity and mortality. association between variables and outcomes will be explored using multivariable logistic regression. critically, new risk prediction models introduced for our clinical setting may reduce avoidable maternal and neonatal morbidity and mortality at local, national, regional and international level.

Eligibility criteria:
inclusion criteria: * participants will be included in the study if they have a diagnosis of severe preeclampsia. * severe preeclampsia will be defined as high blood pressure (systolic blood pressure (sbp) ≥160, diastolic blood pressure(dbp) ≥110mmhg) and or either severe headaches, epigastric pains and deranged biochemical/haematological blood indices. * both singleton and twin/higher order pregnancies will be included. exclusion criteria: -women with mild or moderate preeclampsia or less than 20 weeks' of gestation and those with epilepsy will be excluded from the study.
assessment of outcome of meniscus repair with or without platelet rich plasma

Conditions: Cartilage Disease

Summary: the purpose of this investigation is to determine the clinical outcome of repair of meniscus tears located in the "red/white" region using a well-known suture technique combined, when indicated, with platelet-rich plasma to enhance healing. the outcome of this operation will be determined in a consecutive group of patients with an established, rigorous knee rating system a minimum of 2 years postoperatively. results will be determined by the analysis of subjective and functional factors, sports and occupational activity levels, a comprehensive physical examination, and a radiographic evaluation using standard plain x-rays and magnetic resonance imaging. the investigators hypothesize that meniscus repairs will significantly reduce tibiofemoral compartment pain and allow for increased knee function and activity levels. the platelet rich plasma adjunct will be used in complex meniscus tears in which a portion of the tear extends into the avascular region classified as either longitudinal, horizontal, or radial. the investigators hypothesize that the healing rate of these repairs will be superior to those previously reported in clinical studies in patients who had the suture repair technique alone.

there are many published clinical studies of complex meniscus tears in the red/white region with success rates that vary from 57% to 100%. meniscus repairs that fail in this region usually require subsequent removal, which essentially results in loss of the majority of meniscal function and risk of future disabling osteoarthritis. this study will determine if the addition of platelet rich plasma increases the success rate of complex meniscus repairs of longitudinal, horizontal, or radial tears in the red-white region. the investigators have over two decades of experience with clinical studies of meniscus repairs in patients whose age ranged from 9 to 58 years. those investigations revealed an average success rate in terms of retention of meniscus tissue of 80%. however, meniscus tears classified as horizontal, radial, double longitudinal, and complex multiplanar had success rates of 71-73% which prompted the need for an adjunct therapeutic measure, such as platelet rich plasma, to increase the healing potential in these cases.

Eligibility criteria:
inclusion criteria: * patients scheduled for meniscus repair who provide informed consent to participate exclusion criteria: * patients scheduled for meniscus repair who refuse to participate * presence of a tumor, metastatic disease, active infections, platelet count \< 10 5/hl hgb \< 10 g/dl, pregnancy, active breastfeeding, and allergy to bupivicaine * patients with preexisting thrombocytopenia, hypofibrinogenemia, or who are on anti-coagulant therapy, or who have a potential hypersensitivity to bovine products

Keywords: meniscus avascular region platelet rich plasma
effects of denosumab on the pharmacokinetics of etanercept

Conditions: Postmenopausal; Osteopenia; Rheumatoid Arthritis; Osteoporosis

Summary: the primary objective of the study was to characterize the effects of a single dose of denosumab on the pharmacokinetics (pk) of etanercept in postmenopausal women with low bone mineral density (bmd) and rheumatoid arthritis based on area under the serum concentration-time curve (auc) and maximum observed serum concentration (cmax).


Eligibility criteria:
inclusion criteria: * postmenopausal women (postmenopausal is defined as no vaginal bleeding or spotting for at least 12 months) * low bone mineral density (bmd) as determined by screening bmd t-scores of the lumbar spine (l1 to l4), or total evaluable vertebrae (if fewer than l1 to l4), or total hip ≤ -1.0 * receiving a 50 mg dose of etanercept once weekly ≥ 6 months prior to screening and expected to continue etanercept treatment at this dose and frequency through end of study (eos) * if currently taking methotrexate (mtx), receiving a stable dose (7.5 to 20 mg/week) of mtx ≥ 8 weeks prior to screening * willing and able to take ≥ 1,000 mg elemental calcium and ≥ 400 iu vitamin d daily upon enrollment exclusion criteria: * type 1 diabetes; or poorly controlled type 2 diabetes (hemoglobin a1c (hba1c) \> 8.0% at screening; hba1c ≤ 8.0% within 6 months of screening is acceptable if supporting laboratory documentation is available) * history of heart failure, coronary artery bypass graft, or cardiac arrhythmia; or history of acute coronary syndrome * comorbid autoimmune disease, demyelinating disease, or hematologic abnormalities * history of joint replacement in hand and/or wrist; or history of fused joint in hand and/or wrist * prior history or current evidence of osteonecrosis/osteomyelitis of the jaw; or active dental or jaw condition that requires oral surgery, or non-healed dental/oral surgery; or planned invasive dental procedure(s) during the course of the study * previous exposure to denosumab

Keywords: amgen phase 1 postmenopausal osteopenia rheumatoid bone mineral density arthritis pharmacokinetics osteoporosis
real-world impact of erenumab on sick-leaves, health care resource use and comorbidities.

Conditions: Migraine

Summary: this was a retrospective registry-based study utilizing data collected in association with clinical care of patients. all data was stored in electronic health records at terveystalo data base, and no patients were contacted for the study.

patients initiating erenumab treatment between 20.9.2018 - 15.10. 2019, and data on sick leave days, diagnoses and health care visits as well as medications based on prescriptions were assessed. following time frames for analyses of sick leaves and health care utilization in patients on erenumab treatment and in controls were reported: follow-up analyses: for cases (erenumab) with occupational healthcare, a minimum of 12 months on erenumab treatment was required for the analysis of sick leaves and visits pre erenumab: follow-up data before index (defined as the first reimbursement decision/prescription for erenumab, or initiation of erenumab injections (before reimbursement approval)) from the terveystalo database of those with consent post erenumab: follow-up data after index, from the terveystalo database of those with consent time frames for comparison (sick leaves and visits): one year before index vs. \>12 months erenumab after index, one year before index vs. 6-12 months of erenumab after index (patient years), sensitivity analysis time frames for comparison (medications): 12 months before index vs. 12 months post follow-up controls (triptan treated migraine patients): corresponding time frames as in cases.

Eligibility criteria:
inclusion criteria: * adult patients on erenumab treatment atc: n02cx07 * diagnosis of migraine (icd g43) * consented * occupational healthcare exclusion criteria: none

Keywords: erenumab, cgrp, real world evidence, sick leaves, working impairment, health care visits, prescriptions, migraine
implementation of guidelines on hereditary or familial colorectal cancer

Conditions: Colorectal Neoplasms, Hereditary Nonpolyposis

Summary: the aim of this study is to improve clinicians' calculation, interpretation and communication of familial colorectal cancer risk, as well as patients' risk perception and uptake of referral for genetic counselling or for surveillance by colonoscopy for their relatives at risk.

regular colonoscopy is effective in reducing morbidity and mortality due to colorectal cancer (crc) in patients at increased familial crc risk. currently, the majority of these at-risk individuals are not properly referred for increased surveillance by colonoscopy or genetic counselling. in 2008, a national multidisciplinary evidence-based guideline on familial and hereditary crc was launched in the netherlands. clinicians have new tasks in familial crc risk calculation, interpretation and communication. a clustered randomized controlled trial including an effect, process and cost evaluation will be conducted in eighteen dutch hospitals to determine the most cost effective way to implement these new guidelines. surgeons and gastroenterologists in both the intervention group and the control group will receive background information on familial colorectal cancer risk and the guidelines. patients and clinicians in the intervention group will receive an additional intervention strategy. the effect evaluation is done by assessing the number of crc patients for whom correct risk calculation, interpretation and communication is performed, as well as patients' uptake of the recommended follow up policy. the actual exposure to the different elements of the implementation procedure and the experiences of users will be assessed in the process evaluation. the costs of the implementation procedure will be determined by means of a cost evaluation.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of colorectal cancer before the age of 70 * diagnosed in one of the participating hospitals * able to read and understand dutch exclusion criteria: * previous referral for genetic counseling

Keywords: colorectal neoplasms, (hereditary nonpolyposis) guideline health plan implementation decision support techniques risk assessment familial colorectal cancer risk risk assessment tool
fexofenadine study on filipino children for the relief of perennial and intermittent allergic rhinitis

Conditions: Rhinitis, Allergic, Perennial

Summary: to determine the safety and efficacy of fexofenadine (telfast®) 30mg pediatric tablets on filipino children aged 6 to 11 for the relief of symptoms associated with perennial and intermittent allergic rhinitis.


Eligibility criteria:
inclusion criteria: * children who manifest allergic rhinitis symptoms such as sneezing, rhinorrhea, itchy nose/palate/throat and/or itchy/watery/red eyes.