Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of rth258 versus aflibercept - study 2

Conditions: Neovascular Age-Related Macular Degeneration; Choroidal Neovascularization

Summary: the purpose of this study is to compare brolucizumab (rth258) ophthalmic solution for intravitreal (ivt) injection (6 mg) to aflibercept ophthalmic solution for ivt injection (2 mg) in subjects with untreated active choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd) in the study eye.

subjects were randomized to brolucizumab 6 mg and aflibercept 2 mg in a 1:1 ratio. subjects in both treatment arms received 3 monthly loading doses (day 0, week 4 and week 8), followed by a maintenance regimen, until the end of the study (week 96/exit). all subjects attended pre-specified visits every 4 weeks. subjects in the brolucizumab 6 mg arm followed a q12w/q8w maintenance regimen. within the q12w/q8w regimen, the initial treatment after the loading phase was q12w (1 injection every 12 weeks). if disease activity was identified by the masked investigator at any of the disease activity assessments, dosing was adjusted to q8w (1 injection every 8 weeks) ("q12w/q8w regimen"). once subjects were adjusted to the q8w interval, they stayed on that interval until the end of the study. subjects in the aflibercept 2 mg arm followed a q8w maintenance regimen until the end of the study. results reported up to week 48 are based on the database locked for the primary analysis at week 48. results reported after week 48 are based on the database locked at the end of study (final analysis).

Eligibility criteria:
key inclusion criteria: * provide written informed consent; * active cnv lesions secondary to amd that affected the central subfield in the study eye at screening; * total area of cnv \> 50% of the total lesion area in the study eye at screening; * intraretinal and/or subretinal fluid affecting the central subfield of the study eye at screening; * best corrected visual acuity (bcva) between 78 and 23 letters, inclusive, in the study eye at screening and baseline using early treatment diabetic retinopathy study (etdrs) testing. key exclusion criteria: * any active intraocular or periocular infection or active intraocular inflammation in either eye at baseline; * central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis ≥ 50% of the total lesion in the study eye at screening; * subretinal blood affecting the foveal center point and/or ≥ 50% of the lesion of the study eye at screening; * any approved or investigational treatment for neovascular age-related macular degeneration (namd) in the study eye at any time; * retinal pigment epithelial rip/tear in the study eye at screening or baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to baseline; * pregnant or nursing women; women of child-bearing potential; * stroke or myocardial infarction in the 6-month period prior to baseline.

Keywords: amd cnv ivt
pregnancy rate in direct versus afterload technique of embryo transfer

Conditions: Fertility Issues; IVF; Embryo Transfer

Summary: the primary outcome of the study is to determine if a difference in terms of pregnancy rate exists between direct and afterload embryo transfer (et) techniques. the secondary end points include the evaluation of the difficult transfer rates.

the study database includes all the single fresh and frozen (g5-g6) blastocyst transfers performed at humanitas fertility centre between 1st january 2016 and 31th december 2021 by using the direct and afterload protocols. any blastocysts that underwent preimplantation genetic testing will be excluded from the analysis, as well as embryos derived from gamete donation or those imported from other centers. data are gathered using a specific internal web-based database, which allows to organize, store and readily retrieve information about patients and ivf cycle.

Eligibility criteria:
inclusion criteria: * ivf procedure * fresh and frozen single blastocyst transfer exclusion criteria: * any blastocysts that underwent pgs testing * embryos derived from gamete donation * embryos imported from other centers
carotid endarterectomy versus carotid artery stenting? a prospective comparison of neuropsychological outcome in patients with carotid stenosis.

Conditions: Carotid Stenosis

Summary: in this prospective study, patients with carotid stenosis will be randomly assigned to one of the two surgical procedures (carotid endarterectomy (cea) and carotid stenting (cas)). pre- and postoperative neuropsychological functions, levels of several biomarkers and intraoperative embolization load will be examined. in a subgroup of patients, mri-data will also be gathered. the mix of these data will allow us to answer several questions regarding the absence or presence of preoperative impairments, postoperative changes in cognitive performance and possible differences between cea and cas regarding postoperative neuropsychological functions. the use of a matched control group and implementation of a long term follow-up will contribute to the uniqueness of this study. it will meet several flaws of previous studies and will complete the ongoing randomized studies comparing cea and cas that are lacking neuropsychological data.


Eligibility criteria:
inclusion criteria: * patients with carotid stenosis. exclusion criteria: * significant medical conditions which affect neurocognitive functions (e.g. cancer, epilepsy) * older than 80 years * a history of psychiatric or neurological illness * severe alcohol of drug abuse * coronary artery bypass graft (cabg) less than a year ago.
viokase 16, viokase16 plus nexium and nexium alone

Conditions: Chronic Pancreatitis

Summary: our primary hypothesis is that the addition of nexium to viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to viokase 16 plus placebo or to nexium alone. a secondary hypothesis would be an increase in quality of life. our objective is to elucidate the role of nexium in the control of pancreatic pain, quality of life, and narcotic usage alone or when added to viokase 16. our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased er visits and decreased hospital admissions for abdominal pain.


Eligibility criteria:
inclusion criteria: 1. males and females age 18 to 75 years inclusive. female subjects of child bearing potential or less than two years post-menopausal must use a medically acceptable form of birth control or barrier method and have a negative pregnancy test prior to entry into study. 2. history of abdominal pain associated with chronic pancreatitis 3. evidence of chronic pancreatitis as manifested by an abnormal secretin test, calcification of the pancreas on plain film, an abnormal ct showing a dilated pancreatic duct and/or atrophy, an abnormal endoscopicretrogradecholangeopancreatography (ercp), or diffuse changes on endoscopic ultrasound (eus), fecal elastase \> 100ug/g stool, or serum trypsinogen \> 20ng/ml - exclusion criteria: 1. subjects on enzyme therapy within the last 14 days, proton pump inhibitor (ppi)within the last 7 days, or octreotide within 48 hours. 2. subjects with known hypersensitivity to pork or exogenous or pancreatic enzymes. 3. female subjects who are pregnant or lactating 4. subject use of enzyme therapy other than that called for in this study 5. subject use of therapeutic amounts of antacids or h2 receptor antagonists during the course of the study. 6. past history of documented steatorrhea by 72 hour fecal fat determination or current history consistent with steatorrhea -
sesame street growing together evaluation

Conditions: Family Engagement

Summary: this study aims to evaluate the appeal and effectiveness of sesame workshop's growing together online professional development course.


Eligibility criteria:
inclusion criteria: teachers: * work in an eligible center with a director who has agreed for the center to participate in the study * serve as the lead teacher in a classroom with at least 3 four year olds (can be a co-teacher and can teach a mixed age class) * have access to reliable, high-speed internet * have an email address that can be shared with researchers * read english enough to understand course materials and/or surveys * not have previously accessed the growing together course * be available during the timeframe of the study parents: * have a child who is 4 years old or about to be 4 years old during the weeks of the course enrolled in a classroom at least 3 days in a typical week with a teacher interested in participating in the study * have access to reliable, high-speed internet * have an email address that can be shared with researchers * read english enough to understand course materials and/or surveys * be available during the timeframe of the study exclusion criteria: teachers: * working in an ineligible center * working in a center with a director who has not agreed for the center to participate in the study * not being a lead teacher * not teaching at least 3 four year olds * not having access to reliable, high-speed internet * not willing to share an email address with researchers * being unable to read english enough to understand course materials and/or surveys * having previously accessed the growing together course * not being available during the timeframe of the study parents: * not having a child who is 4 years old or about to be 4 years old during the weeks of the course * not having a child enrolled in a classroom at least 3 days in a typical week * not having a child enrolled in a classroom with a teacher interested in participating in the study * not having access to reliable, high-speed internet * not willing to share an email address with researchers * being unable to read english enough to understand course materials and/or surveys * not being available during the timeframe of the study
glucose monitoring to predict and treat high glucose levels after steroid treatment

Conditions: Breast Cancer; Pancreatic Cancer; Diabetes; Pre Diabetes

Summary: the purpose of this study is to see if continuous glucose monitoring can identify how often people who have pre-diabetes or medical obesity or well-controlled diabetes experience very high glucose values while receiving chemotherapy for breast cancer or pancreatic.


Eligibility criteria:
inclusion criteria: * patient aged 18 or older undergoing neoadjuvant chemotherapy regimens including taxane and/or anthracycline for breast cancer. * patient aged 18 or older undergoing any chemotherapy regimen for pancreatic cancer * have 'high metabolic risk(either pre-diabetes, obesity, or well-controlled diabetes) defined as either: * pre-diabetes and/or obesity group: one or more of known hba1c 5.7-6.5%, fasting glucose \> 100 mg/dl, or bmi \> 30 * well-controlled diabetes: known hba1c \< 7.5 on lifestyle alone or up to one oral antidiabetic agent * any patient undergoing treatment for pancreatic adenocarcinoma on either no antidiabetic agent or up to one oral antidiabetic agent exclusion criteria: * patients with type 1 diabetes, a history of hospitalization for either hyperglycemia or ketoacidosis, a history of hypoglycemia requiring hospitalization, rashes or other skin reactions that would preclude placement of the cgm * use of anticoagulants or antiplatelet agents other than aspirin * platelet count \< 50 k/μl within 60 days prior to enrollment.

Keywords: glucose monitoring 19-315
ublituximab + ibrutinib in select b-cell malignancies

Conditions: Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma

Summary: the purpose of this study is to evaluate the safety and effectiveness of ublituximab in combination with ibrutinib in patients with advanced hematologic malignancies.


Eligibility criteria:
inclusion criteria: * confirmed mantle cell lymphoma (mcl) open for enrollment. the chronic lymphocytic leukemia (cll) enrollment arm is now closed. * refractory to or relapsed after at least 1 prior treatment regimen * eastern cooperative oncology group (ecog) score of 0 to 2 exclusion criteria: * any major surgery, chemotherapy or immunotherapy within the last 21 days * known hepatitis b virus, hepatitis c virus or hiv infection * autologous hematologic stem cell transplant within 3 months of study entry. prior allogeneic hematologic stem cell transplant is excluded. * richter's transformation, prolymphocytic leukemia or primary central nervous system lymphoma
transition to ambulatory bariatric surgery (tabs) trial

Conditions: Obesity and Obesity-related Medical Conditions; Bariatric Surgery

Summary: this study will compare same day discharge and at least one night stay in the hospital after bariatric surgery. patients undergoing bariatric surgery will be randomized (i.e. have an equal chance of either plan) to either group. the study's primary outcome is the frequency patients in the study require a visit to the emergency room within 7 days of their surgery.

this pragmatic, parallel, randomized, open-label trial aims to determine the safety and feasibility of same day discharge (sdd) for bariatric surgery including sleeve gastrectomy and gastric bypass. investigators will investigate the frequency of 7-day emergency department visits with sdd after bariatric surgery (aim 1). in addition, the investigators will compare total 30-day charges between participants who undergo same day discharge versus those receive post-operative hospital admission (aim 2).

Eligibility criteria:
inclusion criteria: * bmi ≤ 60 kg/m2 * primary sleeve gastrectomy or gastric bypass, * undergoing bariatric surgery at sponsor site exclusion criteria: * type 1 diabetes * myocardial infarction * unstable angina or heart failure * prior stroke * solid organ transplantation * systemic glucocorticoid prior 28 days * severe obstructive sleep apnea * uncontrolled hypertension (systolic \> 150, diastolic \> 90) * untreated hyperthyroidism * chronic kidney disease (egfr \< 60) * current anticoagulant use, * poorly controlled type 2 diabetes (hemoglobin a1c in last 3 months \> 8.5%) * chronic opioid use * insulin dependence. * need for extended venous thromboembolic event prophylaxis, * \> 1 lifetime bariatric surgery (revisional or conversion bariatric surgery) * patient lives \> 130 miles from the hospital. * tobacco use in last 12 months * desire to become pregnant or active pregnancy * prisoners * unable or unwilling to follow-up * unable to understand or provide consent

Keywords: ambulatory surgery same day discharge gastric bypass sleeve gastrectomy
childhood reactive thrombocytosis

Conditions: Reactive Thromobocytosis in Children

Summary: reactive thrombocytosis (rt) in pediatric patients is common, but usually without symptoms. the incidence of rt is different depending on age. mostly, we reasoned that rt is a phenomenon, nevertheless the diagnostic value of rt is little known. therefore, the aim of this study was to determine the association of rt and clinical or laboratory characteristics in pediatric diseases.


Eligibility criteria:
inclusion criteria: * the platelet counts more than 500x109/l and age less than 18 years old. exclusion criteria: * repeated hospitalization ( more than 2 times)
pf-06669571 in subjects with idiopathic parkinson's disease

Conditions: Idiopathic Parkinson's Disease

Summary: this study is designed to assess safety, tolerability and pharmacokinetic data for multiple doses of pf-06669571 in subjects with idiopathic parkinson's disease. in addition, this study will assess whether pf-06669571 is able to demonstrate superior efficacy compared with placebo in the treatment of the motor symptoms of idiopathic parkinson's disease.


Eligibility criteria:
inclusion criteria: * subjects must have a clinical diagnosis of idiopathic parkinson's disease and presence of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or bradykinesia). * must be hoehn \& yahr stage ii-iii inclusive and experiencing motor fluctuations in the form of end-of-dose wearing off during the morning hours or early morning akinesia. * subjects should be able to recognize their "wearing off" symptoms and verify that they usually improve after their next dose of parkinson's disease medication. subjects should be able to recognize drug-induced dyskinesias and verify whether or not they are troublesome. exclusion criteria: - history or clinical features consistent with an atypical parkinsonian syndrome, (for example: ataxia, dystonia, clinically significant orthostatic hypotension.
bacterial decolonization to prevent radiation dermatitis

Conditions: Radiation Dermatitis

Summary: the purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (rt) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (rd) and improve quality of life. this study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of rt to be associated with an increased risk of high-grade rd. patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after rt.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * diagnosis of a solid tumor of the breast or head and neck with plans for fractionated radiation therapy (≥ 15 fractions) with curative intent exclusion criteria: * prior rt to the region of interest * existing dermatologic condition affecting the treatment area (eg: atopic dermatitis, psoriasis, and non-healing wounds) * known allergy to chlorhexidine or mupirocin
association between autologous transfusion and recurrence-free survival in patients with hcc after resection

Conditions: Liver Cancer

Summary: this prospective non-randomized controlled trial aims to determine whether autotransfusion of red blood cells salvaged before liver resection is associated with the recurrence-free survival in patients with hepatocellular carcinoma.

preoperative and intraoperative blood salvage autotransfusion is used in various surgical procedures. however, because of the risk of reinfusion of salvaged blood contaminated by tumor cells, the use of autotransfusion in hepatocellular carcinoma (hcc) patients undergoing liver resection is controversial. the critical points include whether tumor cells can be cleared by autotransfusion, whether autotransfusion increases the risk of recurrence or metastasis, and what are the indications for autotransfusion. moreover, some other issues are still not addressed. for example, is it warranted to take the risk of tumor dissemination by using autotransfusion to avoid allogeneic blood transfusion? do the remaining tumor cells after additional filtration by leukocyte depletion filters still possess potential tumorigenicity?

Eligibility criteria:
inclusion criteria: * patients who underwent liver resection; * diagnosis of hepatocellular carcinoma confirmed by postoperative histopathology; * level of preoperative hemoglobin ≥110 g/l; * child-pugh class a or b liver function; * eastern cooperative oncology group performance status (ecog ps) of 0 or 1. exclusion criteria: * a history of other malignancies; * history of active autoimmune or immunodeficiency diseases; * concurrent cardiac, pulmonary, cerebral, or renal dysfunction; * loss to follow-up.
a trial of ns/gemox chemotherapy in patients with untreated pancreatic cancer ( hz-ns/gemox-pc )

Conditions: Pancreatic Cancer

Summary: this is a phase ii , open-label , investigator-initiated trail of sequential gemox/ns chemotherapy in patients with untreated pancreatic cancer. this study aims to evaluate the safety and efficacy of sequential gemox/ns chemotherapy as a first-line treatment of untreated pancreatic cancer.


Eligibility criteria:
inclusion criteria: 1. voluntarily participate in the trial and sign the informed consent form 2. 18 years old \<age \<75 years old 3. histopathological or cytologically confirmed (inoperable) locally advanced or recurrent metastatic pancreatic ductal adenocarcinoma with lesions measurable according to recist criteria 4. ecog score 0-1 5. life expectancy \> 3 months 6. there must be a ct or mri examination within a week 7. at least one lesion that can be measured by the recist v1.1 standard 8. no chemotherapy has been performed (the interval between postoperative adjuvant chemotherapy must be more than 6 months) 9. without radiation therapy (unless there is at least one measurable target lesion in the non-irradiated area) exclusion criteria: 1. pregnant or lactating women; or those who have fertility but refuse to take contraceptive measures; 2. severe active infections requiring intravenous antibiotic treatment during enrollment; 3. those who are allergic to the test drug; 4. there is ≥2 neuropathy (ctcae 4.0); 5. uncontrolled, symptomatic brain metastases or those with a history of uncontrollable psychiatric disorders; severe intellectual or cognitive dysfunction; 6. congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack; 7. have other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin that has been basically controlled; 8. patients who are unable to follow the protocol or who are unable to follow up;