Kornimate/medical-research-clean huggingface dataset:
a real-world evidence study for the incidence of retinal vasculitis (rv) among adult patients receiving aflibercept 2 mg in the united states (us)

Conditions: Retinal Vasculitis

Summary: this study will describe and estimate the incidence of rv events among patients and patient eyes receiving aflibercept intravitreal (ivt) (eylea® 2mg) therapy in us clinical practice. this study will also use clinical record review to confirm cases of rv first identified using international classification of diseases, tenth revision, clinical modification (icd-10-cm) codes and to identify rv with occlusion.

this study is purely descriptive using secondary data from the verana health retinal outcomes module sourced from the american academy of ophthalmology's intelligent research in sight (iris®) registry

Eligibility criteria:
key inclusion criteria: 1. patient-eyes with at least one aflibercept 2 mg injection between january 1, 2017 and june 30, 2023 2. patient-eyes with at least one aflibercept 2 mg injection with a specified laterality. the earliest date of aflibercept injection will be the index date for each patient-eye 3. patient-eyes with diagnosis (documented through icd-10-cm diagnosis code) of namd, dme, dr without dme, dr with me status unknown, and/or me following rvo in the same eye as the aflibercept injection within 14 days prior to the index date (inclusive) key exclusion criteria: 1. patients with aflibercept 2 mg injection within 12 months (365 days) prior to the index date (not inclusive) will be excluded, as defined in the protocol 2. patient-eyes with a diagnosis of rv in the same eye as the aflibercept injection or with unspecified laterality within 12 months (365 days) prior to index date (inclusive), as defined in the protocol 3. aflibercept treatment episodes (aflibercept injections) with unspecified laterality, ophthalmic procedures or surgeries within 60 days prior to the injection date note: other protocol defined inclusion/exclusion criteria may apply

Keywords: anti-vascular endothelial growth factor aflibercept neovascular age-related macular degeneration (namd) diabetic macular edema (dme) diabetic retinopathy (dr) without macular edema (me) diabetic retinopathy (dr) with macular edema (me)
comparative outcomes between image-based versus imageless robot-assisted unicondylar knee arthroplasty

Conditions: Osteoarthritis, Knee; Arthropathy of Knee

Summary: this prospective cohort study was conducted with the aim of comparing relevant clinical outcomes which included intra (surgical time and blood loss), post-operative outcomes (range of motion, function, complications and revisions) and return to activity between imageless and image-based surgical system in medial unicondylar knee arthroplasty

this prospective cohort study was conducted between 1st june 2015 and 1st july 2018 at bhumibol adulyadej hospital, bangkok, thailand. a total of 33 medial compartment oa knee patients were randomly allocated to mako or navio robotic assisted uka. the outcomes assessed were intra-operative outcomes (operative time, blood loss) and postoperative outcomes (function, complications and revision) at 1 year after surgery.

Eligibility criteria:
inclusion criteria: * patients were those deemed suitable for unicondylar knee arthroplasty surgery * patients who could give informed consent * patients who willing to attend the prescribed follow-up. exclusion criteria: * patients who have medial osteoarthritis knee with following condition: 1. ligament insufficiency (anterior cruciate ligament rupture, collateral ligament insufficiency). 2. inflammatory arthritis 3. a deformity requiring augmentation 4. neurological movement disorders 5. pathology of the feet, ankles, hips, or opposite knee causing significant pain or gait alterations * patients who ultimately required a total knee arthroplasty (valgus greater than 14 degree, multiple compartment osteoarthritis were contraindications to unicondylar knee arthroplasty.

Keywords: mako navio robotic surgery uka surgical time kss kfs
navigating the grey zone for antenatal corticosteroids

Conditions: Decision Making, Shared; Pregnancy; Preterm Birth

Summary: the purpose of this study is to find out if including a decision support tool in clinical practice guidelines will improve how doctors discuss the option of antenatal corticosteroid treatment with patients who might deliver at 34 to 36 weeks of pregnancy.


Eligibility criteria:
inclusion criteria: * age 18 year or older. * delivered a live neonate at 34+0 to 36+6 weeks of gestation. * speaks english. * agrees to participate in the questionnaire during their first week post-partum. * delivered at one of the six participating obstetrical hospitals. exclusion criteria: * none.

Keywords: antenatal corticosteroid
study of brentuximab vedotin combined with rchop or rchp in front-line treatment of patients with diffuse large b-cell lymphoma (dlbcl)

Conditions: Lymphoma, B-cell; Lymphoma, Large B-cell, Diffuse

Summary: this study has 3 parts. the purpose of part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with rchop (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as bv+rchop) in patients with dlbcl who have never been treated. patients will be randomly assigned in a 1:1 ratio to receive rchop together with 1 of 2 doses of brentuximab vedotin. patients will be tested to see if there is a difference in side effects between the 2 groups. the purpose of part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with rchp (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as bv+rchp) in patients with cd30-positive dlbcl who have never been treated. patients will be enrolled to receive rchp together with 1.8mg/kg of brentuximab vedotin. the purpose of part 3 of this study is to assess the safety and efficacy of bv+rchp compared to standard rchop in patients with cd30-positive dlbcl that have never been treated. patients will be randomly assigned in a 1:1 ratio to receive either bv+rchp or rchop. patients will be tested to see if there is a difference in side effects between the 2 groups.

in the first part of this study, patients in the 2 groups were tested to see if there was a difference in the response to treatment and whether there were differences in the side effects (unwanted effects). the second and third parts of the study are being done to see if there are any side effects (unwanted effects) of the higher dose of brentuximab vedotin when combined with a modified version of rchop that omits vincristine. the third part of the study is being done to see if there is a difference between bv+rchp and rchop in the response to treatment.

Eligibility criteria:
inclusion criteria: * treatment-naive patients with systemic de novo or transformed diffuse large b cell lymphoma (dlbcl) or follicular non-hodgkin lymphoma (nhl) grade 3b * international prognostic index (ipi) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted ipi (aaipi) score of 2 or 3 for patients less than or equal to 60 years of age * stage iax (bulk defined as single lymph node mass \>10 cm in diameter), ib-iv disease * measurable disease of at least 1.5 cm * eastern cooperative oncology group (ecog) performance status less than or equal to 2 * patients in parts 2 and 3 must have histologically confirmed diagnosis of cd30-positive dlbcl exclusion criteria: * previous history of treated indolent lymphoma * history of another primary malignancy that has not been in remission for 3 years

Keywords: antibodies, monoclonal antibody-drug conjugate antigens, cd30 drug therapy hematologic diseases lymphoma, b-cell lymphoma, large b-cell, diffuse monomethyl auristatin e
a study of three doses of tch346 in patients with early parkinson's disease to evaluate safety and efficacy

Conditions: Parkinson's Disease

Summary: this study will investigate the effect of tch346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents

this study will investigate the effect of tch346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents

Eligibility criteria:
inclusion criteria: * male or female ,aged 30-80 years * clinical diagnosis of early stage idiopathic parkinson's disease * experiencing two of the three following signs; bradykinesia, rigidity, and tremor * not currently taking any antiparkinson medication exclusion criteria: * a history of alcohol or drug abuse in the past year * a diagnosis psychiatric illness * patients who currently are taking mao inhibitors within 30 days of entering the study * patients who are hypersensitive to selegiline, mao-b inhibitors, or tricyclic antidepressants additional inclusion/exclusion criteria may apply

Keywords: early stage idiopathic parkinson's disease
food response training for binge eating

Conditions: Binge Eating

Summary: this study will examine the effectiveness of food response training interventions in reducing binge eating among adults engaged in binge eating.

binge eating disorder is the most prevalent eating disorder and affects both men and women at comparable rates unlike anorexia nervosa and bulimia nervosa. given that binge eating and obesity are strongly associated, binge eating treatments should aim to reduce binge eating as well as weight. however, most binge eating interventions do not produce lasting weight loss. recent research has shown computer-based response inhibition training with high-calorie foods reduces reward region response to and attentional bias for the training foods, decreases training food intake, increases inhibitory control, and produces weight loss in overweight adults. there is evidence that the weight loss effects from such response training persist through 6-month follow-up. further, binge eating has been associated with increased food-related impulsivity and increased activation in a reward-processing brain region to high-calorie foods. prior research suggests that food response training may be an effective intervention for binge eating that teaches automatic self-control in response to high-calorie foods which in turn, reduces binge eating and produces weight loss. this study will examine the effectiveness of food response training interventions in reducing binge eating and weight among adults engaged in binge eating. the goals of this study are to: (1) test the hypothesis that adults who complete the food response trainings will show significantly greater reductions in binge eating frequency and in body mass index (bmi) compared to generic response training from pretest to posttest and at 3-month follow up, (2) to determine whether one of the food response trainings is more effective in binge eating frequency and reducing bmi from pretest to posttest and at 3-month follow up, and (3) test whether a reduction in valuation of the high-calorie versus low-calorie foods (willingness to pay for the pictured foods) and/or behavioral improvement of inhibitory control during the training tasks mediate the effects of the various trainings on reductions in binge frequency and body mass index.

Eligibility criteria:
inclusion criteria: * engages in objective binge episodes as defined by the diagnostic and statistical manual of mental disorders (dsm-5) and meets one of the following frequency and duration criteria: 1) at least two objective binge episodes per month for at least 3 months; or 3) at least six objective binge episodes over a shorter period exclusion criteria: * illicit drug use and excessive alcohol use

Keywords: binge eating obesity overeating
fenofibrate versus curcumin in type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to evaluate the effect of fenofibrate versus curcumin on glycemic status, lipids profile, hs-crp, sirtuin-1 and fetuin-a in type 2 diabetic patients who are taking glimepiride.

method \& proposal steps 1- approval will be obtained from research ethics committee of faculty of pharmacy, damanhour university. 2- all participants agreed to take part in this clinical study and provide informed consent. 3- (60) patients with dm type 2 who's taking glimepiride will be enrolled from internal medicine department, tanta university hospital. 4- serum samples will be collected for measuring the biomarkers. 5- all enrolled patients will be mentioned as two groups; group i are patients who will be prescribed glimepiride plus fenofibrate. group ii are patients who will be prescribed glimepiride plus curcumin. 6- all patients will be followed up during 3 months' period. 7- at the end of 3 months on the new regimen, steps 4 will be repeated. 8- statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 9- measuring outcome: the primary outcome is the change of serum levels of the measured markers after 3 months and lipid profile. 10- results, conclusion, discussion and recommendations will be given. methodology serum levels of fetuin-a, and sirtuin1 (sirt1) will be measured elisa. lipid profile. fasting blood glucose and 2 hrs postprandial blood glucose. hb a1c will be measured. bmi of the patients will be measured before and after the study. high sensitivity c-reactive protein (hs-crp) will be measured.

Eligibility criteria:
inclusion criteria: * 60 patients with type 2 dm diagnosed clinically. * the age ranged from 35 to 70 years. * there are no limits to the duration of dm and gender. * hba1c ≥ 7 exclusion criteria: 1. other types of dm 2. hypersensitivity to the drug 3. abnormal liver function 4. patients with renal impairment (egfr ≤ 60 ml/min) 5. addition of any antidiabetic medications or insulin during follows up. 6. pregnancy, lactation or child-bearing potential. 7. no insulin therapy and no use of antioxidants, multivitamin.
qbsafe: a randomized trial of a novel intervention to improve care for people living with type 2 diabetes.

Conditions: Type2Diabetes; Diabetes

Summary: glycemic control is often the main indicator of successful diabetes care, but a singular focus on glycemic control may lead to patients' overall health and wellbeing being overlooked or undervalued. the investigators have previously developed an intervention comprised of (a) a set of conversation cards designed to enable patients to identify aspects of life with diabetes important to them and to share them with their clinician to obtain their input; and (b) materials that help clinicians respond to patient concerns. the investigators will now conduct a randomized clinical trial to test the feasibility of the research procedures and efficacy of the intervention with respect to patient reported outcome measures.

the goal of this study is to assess the feasibility and efficacy of usual care with the qbsafe intervention compared to usual care alone within a cluster randomized clinical trial among patients with type 2 diabetes.

Eligibility criteria:
inclusion criteria: clinicians * any physicians, residents, nurse practitioners, and physician assistants who participate in the care of patients with type 2 diabetes (dm2) management (dm2) and prescribe medications for them participants * diagnosed with dm2 * able to sign informed consent * fluent in either english or spanish * hba1c \>8% exclusion criteria: * participants for whom an hba1c target \>8% is clinically reasonable (e.g., those with limited life expectancy) and/or aligned with goals/preferences

Keywords: a1c hba1c
pilot trial of a novel cooking skills intervention (dppcooks) to prevent diabetes

Conditions: Pre-diabetes

Summary: in this pilot trial participants will be randomized 1:1 to participate in either standard diabetes prevention program (dpp) vs. dpp plus a novel cooking skills intervention (dpp cooks). the researchers hypothesize that participants randomized to dpp cooks will have greater weight loss, better diet quality at 4 months, and greater confidence in their cooking skills and ability to implement dietary changes recommended in the dpp.

this study is a randomized pilot trial testing a novel cooking skills intervention (dpp cooks) vs. the standard diabetes prevention program (dpp). the dpp is a widely disseminated evidenced-based lifestyle behavior change program to help adults with pre-diabetes lose weight and prevent type-2 diabetes. in this trial the investigators will test whether the addition of food-agency based cooking skills classes improves the effectiveness of the dpp. this trial will take place in baltimore, md in collaboration with community partner dpp providers. the trial has been informed by formative work with prior dpp participants and has used a community based participatory research (cbpr) approach to developing the dpp cooks intervention. participants will be randomized 1:1 to participate in either standard dpp vs. dpp cooks. the length of the trial will be 12 months and outcomes will be measured at baseline, 4 months, and 12 months.

Eligibility criteria:
inclusion criteria: * adults in baltimore city * eligible for dpp based on centers for disease control guidelines * possession of a smart phone with camera * can commit to 12 month study participation exclusion criteria: * current or prior diagnosis of type 1- or type 2 diabetes * non-english speaker * participating in another research study that may effect diabetes, diet, or weight loss * currently pregnant
diagnosis of pathological complete response by minimal invasive biopsy after neoadjuvant chemotherapy in breast cancer

Conditions: Breast Neoplasms

Summary: the study aims to evaluate the ability of representative vacuum-assisted minimal invasive biopsy (vab) to diagnose pathological complete response (pcr=ypt0) in breast cancer patients after neoadjuvant chemotherapy (nact).

neoadjuvant chemotherapy (nact) is an increasingly used approach for patients with locally advanced and primarily inoperable breast cancer or for patients with potentially chemosensitive tumors. in clinical routine surgical treatment follows the pre-operative chemotherapy. however, recent studies have demonstrated that shrinking tumors need less surgical treatment indicating that patients with pcr could potentially be spared of surgery in the future. up to now, prediction of pcr after nact, i.e. diagnosing a pcr without surgery, is based on tumor biology at diagnosis, the applied nact regimen and breast imaging results; all with mediocre accuracy. this prospective, monocenter diagnostic trial aims to explore if minimal invasive biopsies (mib) might overcome this diagnostic challenge. from september 1st, 2014 to february 15th, 2015 the investigators performed ultrasound guided vacuum-assisted minimal invasive biopsy (vab) on 50 breast cancer patients after nact and directly prior to surgery. to analyse vab pathologically results were categorized as follows: residual vital tumor cells (invasive, in situ, both, lymphangiosis carcinomatosous) present, (significant parts of) the tumor bed present, neither vital tumor cells nor (significant parts of) the tumor bed (indicating a non representative vab). the results were compared to those of the pathological examination of surgical specimen.

Eligibility criteria:
inclusion criteria: the investigators included patients * after neoadjuvant chemotherapy (nact) according to the nact protocol * with at least one detectable mass / marker after nact in ultrasound * with ct1c-ct4a-c tumors * after informed consent * with unilateral or bilateral primary breast cancer, confirmed histologically prior to chemotherapy * with known grading, er/pgr/her-2neu- and ki-67 status * with breast ultrasound, mammography (and breast mri where necessary) before and after nact * clinical / imaging partial or complete response to nact exclusion criteria: the investigators excluded patients from the study with * nact \<12 weeks because of termination due to progressive disease, massive adverse events or patient wish * non-detectable mass in ultrasound / dislocation of marker (\> 10mm distance to the initial lesion) * ct4d stage (inflammatory breast cancer) * m1 stages * stable disease according to a multimodal assessment of ultrasound, mammography and breast mri (if available) according to recist
systematic lymphadenectomy during interval debulking surgery in advanced epithelial ovarian cancer

Conditions: Ovarian Cancer; Postoperative Complications; Neoadjuvant Therapy; Lymph Node Excision

Summary: the study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (nact) followed by interval debulking surgery (ids). the main question it aims to answer is: does systematic lymphadenectomy during interval debulking surgery have a significant impact on survival in patients with advanced epithelial ovarian cancer who have received neoadjuvant chemotherapy? the progression-free survival (pfs), overall survival (os), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups to answer the question.

the study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (nact) followed by interval debulking surgery (ids). the study included patients with histologically confirmed advanced epithelial ovarian cancer who received ids at seven tertiary hospitals in china from 2006 to 2021. the progression-free survival (pfs), overall survival (os), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups. propensity score matching (psm) and overlapping weight (ow) analyses were performed to minimize selection bias.

Eligibility criteria:
inclusion criteria: 1. consecutive patients with advanced epithelial ovarian cancer (stage iib-iv, according to the international federation of gynecology and obstetrics (figo) 2014); 2. patients who underwent nact followed by ids. exclusion criteria: 1. patients with early-stage ovarian cancer (figo stage i-iia); 2. patients only receiving primary debulking surgery (pds) as initial treatment without nact; 3. histological subtypes other than advanced epithelial ovarian cancer; 4. patients with unclear sites of lymphadenectomy and non-compliant systematic lymphadenectomy that not include pelvic and/or para-aortic lymph nodes.

Keywords: advanced epithelial ovarian cancer lymphadenectomy neoadjuvant chemotherapy interval debulking surgery prognosis postoperative complication