Kornimate/medical-research-clean huggingface dataset:
stereotactic pelvic adjuvant radiation therapy in cancers of the uterus

Conditions: Endometrial Cancer

Summary: advanced technology has enabled radiation oncologists to more accurately and precisely target radiation to areas at risk while maximally sparing healthy tissue. a secondary result of these technologic advances has been the increased utilization of hypofractionationed treatment protocols, since the combined ability to better visualize and precisely deliver radiation to target volumes has allowed radiation oncologists to leverage the therapeutic ratio toward higher target doses whilst maintaining safe doses to the pertinent organs-at-risk. the spectrum of hypofractionation ranges from what are considered moderate (ie. 2- 5 gy / fraction) into the realm of what is more commonly referred to as stereotactic body (sbrt), generally \>5 gy / fraction. there is growing evidence demonstrating both safety and efficacy for sbrt. the investigators propose that these advantages are translatable to the adjuvant treatment of endometrial cancer. the investigators submit that a prescription dose of 30 gy in 5 fractions. through precision delivery and careful dosimetry the treatment should be safe and well tolerated with minimal impact on patient quality of life.


Eligibility criteria:
inclusion criteria: * histologically confirmed endometrial adenocarcinoma * patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions: * patient has serous, clear cell, carcinosarcoma or differentiated histologies. * outer-half myometrial invasion and figo grade 1-2 or * figo stage ii - iiic1. * willing and able to give informed consent to participate in this clinical trial. * age ≥18 years. * are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments. * willing and able to complete the qlq-c30 questionnaire with en-24 companion as described in the study protocol. * primary language of the patient must be english or, if a patient's primary language is not english, they are still able to participate provided the qlq-c30 and en-24 is available in their primary language. exclusion criteria: * has had prior pelvic radiotherapy. * has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease. * has a contraindication to iodinated ct contrast. * has a hip prosthesis.
rosuvastatin use to improve the coagulation profile in patients with venous thrombosis

Conditions: Deep Vein Thrombosis; Pulmonary Embolism

Summary: epidemiological studies have shown a 2-3 fold increased long-term risk of arterial cardiovascular disease after venous thrombosis, most predominant in the first year following initial venous thrombosis. the results of recent observational studies that showed 40-50% risk reductions for first venous thrombosis occurrence when using a statin are in this aspect promising. the results are also somewhat surprising, because the mechanism behind this effect is unclear. dyslipidemia may be the most plausible explanation to be considered. however, as dyslipidemia is not related to an increased risk of venous thrombosis, it is unlikely that statins decrease venous thrombosis risk by lipid lowering activities. recent observations indicate that coagulation can activate the initial formation of atherosclerosis. our hypothesis is therefore that the coagulation profile in persons with venous thrombosis is improved when using a statin, ultimately leading to less atherosclerosis: another well known property of statin use.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * persons with (initial or recurrent) confirmed symptomatic proximal deep vein thrombosis or pulmonary embolism who after a time period of at least 3 to 12 months are allowed to stop, - or stopped using \< 1 month anticoagulant treatment as indicated by their treating physician * persons aged 18 years or above exclusion criteria: * persons already using statins or lipid lowering drugs, or any other disallowed concomitant medications (erythromycin, hiv protease inhibitors, or cyclosporine) * history of statin-induced myopathy, or serious hypersensitivity reaction to other hmg-coa reductase inhibitors (statins), including rosuvastatin * life expectancy less than 6 months * pregnant woman or woman with childbearing potential who are not willing to use contraception * active liver or kidney disease or dysfunction or muscle disorders * unstable medical or psychological condition that interferes with study participation

Keywords: deep vein thrombosis pulmonary embolism rosuvastatin treatment pharmacologic actions
pharmacogenomics effects on high-dose methotrexate clearance in patients with diffuse large b-cell lymphoma

Conditions: Central Nervous System Lymphoma; Diffuse Large B-Cell Lymphoma

Summary: this study evaluates pharmacogenomic effects on high-dose methotrexate clearance in patients with diffuse large b-cell lymphoma.

primary objectives: i. to identify snps associated with delayed mtx clearance. ii. to explore any association between snps and increased toxicity. outline: this is an observational study. participants undergo blood sample collection and have their medical records reviewed on study.

Eligibility criteria:
inclusion criteria: * \* adult (age ≥ 18 years at diagnosis) * diagnosis of dlbcl or pcnsl * planned to undergo treatment with hdmtx (≥ 3 g/m\^2) at the james cancer hospital. note: patients with ckd are eligible to participate regardless of egfr provided the treating physician is planning a dose of hdmtx of at least 3 g/ m\^2. * ability to provide informed consent. exclusion criteria: * \* patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, or confound data interpretation * pregnancy (positive serum or urine pregnancy test), lactating or breast feeding * prisoners or incarcerated patients * total bilirubin \> 5 mg/dl
epidemiological monitoring of covid-19 patients hospitalized on reunion island

Conditions: COVID-19

Summary: the island of reunion, a french overseas department of 860,000 inhabitants, located in the indian ocean (oi) zone, recorded its first case of covid-19 on march 11, 2020. the epidemic, which was described as not very severe during the year 2020 in reunion was much more intense and more deadly in 2021, with the arrival of the new variants (south african and indian) and exploded at the beginning of the year 2022 (variant omicron). reunion has a specific island context both climato-geographically and demographically. indeed, this french island located in the southern hemisphere in the middle of the indian ocean (oi) has a tropical climate and a multi-ethnic population, younger than in mainland france (16% are over 60 years old). it is also marked by a higher prevalence in the general population of certain risk factors, such as obesity (11%) and type 2 diabetes (\>10%), recognized as factors favoring severe clinical forms of covid-19. as well as "persistent covid-19". this study will allow the constitution of a large-scale french cohort located in a closed overseas territory to provide answers to local specificities and to the management of the epidemic in the territory.


Eligibility criteria:
inclusion criteria: * over 18 years old * having been hospitalized at the university hospital center (chu) of reunion (minimum of one night in the hospital) * with a positive diagnosis of covid-19 (positive rt(reverse transcription)-pcr(polymerase chain reaction) sars-cov-2 on a nasopharyngeal swab or positive serology or confirmed diagnosis in the medical file) * registered in the covidepi database * whose telephone numbers are available in the computerized patient file * residing on the island of reunion * knowing how to understand and speak french exclusion criteria: * deceased * opposing the use of their data * deprived of liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or curators
cardiac t2* in beta-thalassemia patients on deferasirox treatment

Conditions: Beta-thalassemia; Iron Overload

Summary: the purpose of this trial is to evaluate changes in cardiac iron as measured by mri t2\* in beta-thalassemia patients with deferasirox treatment.


Eligibility criteria:
inclusion criteria: * male or female β-thalassemia outpatients on chronic transfusion therapy (defined as \> 8 transfusions per year) * lifetime minimum of 100 previous packed red blood cell transfusions * patients currently on chelation therapy will require a one day wash out prior to the first dose of study drug * age ≥ 10 years * sexually active females of childbearing potential must have a negative serum or urine pregnancy test and use an effective method of contraception, or must have undergone clinically documented total hysterectomy. exclusion criteria: * ejection fraction \< 56 % measured using steady-state free precession imaging by mri * contraindication to mri, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other mri incompatible metal implants or intractable claustrophobia * abnormal laboratory values as defined by the protocol * clinical or laboratory evidence of active hepatitis b or hepatitis c * history of hiv positive test result (elisa or western blot) * uncontrolled systemic hypertension * second or third degree a-v block * life-threatening arrhythmias, including sustained ventricular tachycardia and aborted sudden death, within the last year * history of cardiac conditions or unstable cardiac disease not controlled by standard medical therapy * history of clinically relevant ocular toxicity related to iron chelation * systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment * pregnancy or breast feeding (documented negative pregnancy test required for study entry) * patients enrolled in an ongoing clinical trial of deferasirox (icl670) cannot be withdrawn in order to participate in this study * treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days * other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug * history of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative * other inclusion/exclusion criteria may apply

Keywords: iron chelation deferasirox chelator desferal beta-thalassemia iron overload
device based therapy in hypertension extension trial

Conditions: Hypertension

Summary: this clinical investigation is designed to describe the long-term safety and efficacy of the cvrx rheos baroreflex hypertension therapy system in patients who participated in the debut-ht study beyond the original follow up period (4-months or longer). the information obtained in this trial is intended to support regulatory approvals and market release of this therapy.

this extension study, designed as a long-term follow up, will monitor the course of the disease and its treatment safety and efficacy by collecting the appropriate data and using data collected under the long term provisions of the debut-ht study to describe and analyze the changes in ongoing drug treatment, the programming parameters of the implanted active device and any occurring adverse events over a period of up to 13 months after implant surgery in the debut-ht trial. annual follow-ups of up to five years are planned subsequently to the 13-month follow-up period.

Eligibility criteria:
inclusion criteria: * have completed the follow-up period (4-month or longer) of the debut-ht trial (protocol no.: 360004-001) * have signed an approved informed consent form for participation in this study exclusion criteria: * are unable to comply with protocol requirements. * are enrolled in another concurrent clinical trial.

Keywords: refractory hypertension high blood pressure uncontrolled blood pressure
a study of amivantamab and folfiri versus cetuximab/bevacizumab and folfiri in participants with kras/nras and braf wild-type colorectal cancer who have previously received chemotherapy

Conditions: Colorectal Neoplasms

Summary: the purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (folfiri) versus either cetuximab or bevacizumab and folfiri given to participants with kirsten rat sarcoma viral oncogene/ neuroblastoma ras viral oncogene homolog (kras/ nras) and v-raf murine sarcoma viral oncogene homolog b (braf) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.


Eligibility criteria:
inclusion criteria: * have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. participants must have recurrent, unresectable or metastatic disease * be diagnosed to have kras, nras, and braf wild-type (wt) tumor as determined by local testing * must agree to the submission of fresh or archival tumor tissue post-progression from the most recent therapy, if clinically feasible * have measurable disease according to recist v1.1 * have an eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 * participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mcrc), with documented radiographic disease progression on or after this line of therapy exclusion criteria: * has medical history of (noninfectious) interstitial lung disease (ild) /pneumonitis/pulmonary fibrosis or has current ild/pneumonitis/pulmonary fibrosis, or where suspected ild/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening * has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of folfiri * has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s) * participant with known mismatch repair deficiency (dmmr)/ high microsatellite instability (msi-h) status who has not received immunotherapy treatments * participant with known human epidermal growth factor receptor 2 (her2)- positive/amplified tumor * has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (egfr) or mesenchymal epithelial transition (met)
high versus standard volume hemodiafiltration in asia

Conditions: End-stage Renal Disease

Summary: online hemodiafiltration (hdf) may improve clinical outcome in end-stage renal disease. the supported mechanism is the improved clearance of uremic toxins by convective transporter. however, it has not been elucidated which convection volume is optimal, especially in asia. a total of 60 participants receiving conventional hemodialysis will be randomly assigned to receive either high dose convective volume (33-43 l/treatment) post-dilution online hdf or standard dose (16.8-21.5 l/treatment) for 24 weeks. the primary outcome is the change of serum β2 microglobulin levels between baseline and after 24 weeks. the secondary outcomes will include changes in the nutritional markers, inflammatory markers, and blood pressure from baseline to after treatment. this would be the first multicenter prospective, randomized controlled trial to determine whether large convective volume improves the treatment efficacy in korean patients undergoing post-dilution online hdf.


Eligibility criteria:
inclusion criteria: * patients on thrice-weekly standard hemodialysis for \> 3 months * patients with a vascular access capable of delivering consistently a high blood flow rates ( ≥ 300 ml/min) * patients willing to provide written informed consent. exclusion criteria: * patients with active infectious or uncontrolled inflammatory disorders * patients with any uncontrolled malignant disease * patients with recent major cardiovascular disease during the last 6 months * patients who are likely to receive kidney transplant within the following 1 year * patients whose life expectancy \< 12 months * patients considered by investigator to have difficulty in participation

Keywords: beta 2-microglobulin hemodiafiltration convective volume
study of melflufen (melphalan flufenamide) in combination with daratumumab in relapsed-refractory multiple myeloma

Conditions: Relapsed Multiple Myeloma; Relapsed-Refractory Multiple Myeloma

Summary: this was a randomized, controlled, open-label, phase 3 multicenter study which enrolled patients with relapsed-refractory multiple myeloma (rrmm) who were either double refractory to an immunomodulatory drug (imid) and a proteasome inhibitor (pi) (regardless of the number of prior lines of therapy), or had received at least 3 prior lines of therapy including an imid and a pi. patients received treatment with melflufen+dexamethasone+daratumumab or daratumumab until documented progressive disease, unacceptable toxicity, or patient/treating physician decision. patients in the daratumumab treatment arm had the option to receive treatment with melflufen+dexamethasone+daratumumab after confirmed progressive disease.


Eligibility criteria:
inclusion criteria: * a prior diagnosis of multiple myeloma with documented disease progression after the last line of therapy * double refractory to an imid and a pi (regardless of the number of prior lines of therapy) or have received at least 3 prior lines of therapy including an imid and a pi * prior treatment with daratumumab or another anti-cd38 antibody may be allowed under certain circumstances: * achieved at least partial response (pr) and not refractory to an anti-cd38 antibody * at least 6 months since the last dose of anti-cd38 antibody * not discontinued anti-cd38 antibody treatment due to related grade ≥ 3 toxicity * male and female of childbearing potential agree to use contraception during the treatment period and at least 3 months after the last dose exclusion criteria: * primary refractory disease (i.e., never responded with at least minimal response to any prior therapy for multiple myeloma) * prior treatment with cd38 car-t cell therapy or cd38/cd3 bispecific antibodies * any medical condition that may interfere with safety or participation in this study * other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast, or very low and low-risk prostate cancer in active surveillance * known or suspected amyloidosis, plasma cell leukemia, or poems syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) * known central nervous system (cns) or meningeal involvement of myeloma * prior stem cell transplant (autologous and/or allogenic) within 6 months of initiation of therapy or prior allogeneic stem cell transplantation with active graft-versus-host-disease * prior treatment with melflufen
a study of first line treatment with avastin (bevacizumab) in combination with carboplatin and weekly paclitaxel in patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: this single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on day 1 of each cycle, paclitaxel 80 mg/m\^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (auc) of 6 on day 1 of each cycle. following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.


Eligibility criteria:
inclusion criteria * female patients, ≥ 18 years of age. * epithelial ovarian, fallopian tube, or primary peritoneal cancer. * initial surgery, but no chemotherapy or radiotherapy. * eastern cooperative oncology group (ecog) performance status of 0-2. exclusion criteria * non-epithelial tumors. * ovarian tumors with low malignant potential. * previous systemic anti-cancer therapy for ovarian cancer. * history or evidence of synchronous primary endometrial cancer. * current or recent daily treatment with aspirin (\> 325mg/day) or with full dose anticoagulant or thrombolytic agents for therapeutic purposes.
impact of financial incentives

Conditions: Human Papilloma Virus

Summary: this trial will look at the impact of clinic-level financial incentives to improve provider communication and increase hpv vaccine uptake. some clinics will receive communication training. other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase hpv vaccine uptake.

the researchers will conduct a cluster randomized control trial. this trial will look at the impact of clinic-level financial incentives to improve provider communication and increase hpv vaccine uptake. the recruitment goal for the trial is 34 clinics in healthcare systems, including 9 rural-serving clinics. the researchers will randomize clinics using simple randomization (1:1). some clinics will receive communication training. other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase hpv vaccine uptake. the researchers will use medical record data to compare changes in hpv vaccination among children ages 9-12. clinics will be followed for 24 months. the study will engage clinical staff. researchers will not have direct contact with children or their families.

Eligibility criteria:
this trial will enroll clinics and intervene with clinical staff. we will use vaccination data from children to evaluate intervention effectiveness. we will not enroll children or interact with them directly. inclusion criteria: clinics are eligible if they are a pediatric or family medicine clinic in north carolina that in the past year had: * less than 72% hpv vaccine initiation rate, * greater than or equal to 50 patients ages 9-12 * greater than or equal to 2 hpv vaccine providers * no clinic or provider-level financial incentive programs to increase system, clinic, or provider hpv vaccination rates among patients aged 9-12 in the past two years, and * no hpv vaccine provider communication trainings in the past six months. children's medical records will be eligible to be included in the dataset if children: * are between the ages of 9-12 years at baseline and * are attributed to a participating clinic at 12- or 24-month follow-up. exclusion criteria: clinics are excluded if they: * do not provide hpv vaccine to children ages 9-12 * have a specialty other than pediatrics or family medicine * had an hpv vaccine-specific financial incentive program in the past two years * had a formal hpv vaccine communication training in the past 6 months * had an hpv initiation rate greater than 72$ * had fewer than 49 patients aged 9-12 * had 1 or fewer hpv vaccine providers children's medical records will not be eligible to be included in the dataset if children: * are not between the ages of 9-12 years at baseline * are not attributed to a participating clinic at 12- or 24-month follow-up

Keywords: financial incentives pediatric medicine vaccination pay-for-performance