Kornimate/medical-research-clean huggingface dataset:
reducing cancer disparities for american indians in the rural intermountain west

Conditions: Prostate Cancer; Colorectal Cancer; Breast Cancer; Cervical Cancer; Lung Cancer

Summary: the purpose of this demonstration is to evaluate the effectiveness of using community outreach workers (navigators) to help american indians living in rural areas overcome barriers to appropriate cancer screening, diagnosis, and treatment.

even for american indians who have coverage with medicare, disparities have been noted in the provision of cancer screening, diagnosis, and treatment. these disparities have been related to a variety of health-system, health-financing, geographic, and cultural barriers. we hypothesize that the use of lay community outreach workers will be an effective means of identifying and overcoming these barriers in order to improve the proportion of medicare-eligible american indians who receive recommended screening and diagnosis for prostate, breast, colon, and cervical cancer, and the proportion of individuals receiving appropriate treatment for prostate, breast, colon, cervical, and lung cancer. community clusters randomized to this form of cancer navigation will be compared with community clusters randomized to receive educational outreach only.

Eligibility criteria:
inclusion criteria: * enrolled in medicare part b * self-reported american indian exclusion criteria: * have cancer other than study cancer * medicare part c enrolled

Keywords: cancer screening navigators community outreach behavioral change access
comparison of precision in brackets position in two indirect bonding materials

Conditions: Orthodontic Appliance Complication; Malocclusion

Summary: objective: to compare the cementation precision of self-ligating brackets between two indirect bonding materials: polyvinylsiloxane and thermal glue. methods: split-mouth randomized clinical trial study, with 15 participants. the study will be divided into two groups, group 1: polyvinylsiloxane and group 2: thermal glue.

patients from the self-ligation clinic who meet the inclusion criteria will be invited to participate and sign the informed consent. for the cementation of the brackets in each patient, the upper arch (right and left) will be divided from the second premolar on the right side to the second premolar on the left side, randomly assigned, to be cemented with a polyvinylsiloxane transfer tray and the other with thermal glue (materials selected for the study).

Eligibility criteria:
inclusion criteria: * permanent dentition with the presence of teeth 15-25 with * crowding in the upper arch according to little's irregularity index, * teeth with healthy enamel (without hypoplasias, fluorosis, amelogenesis imperfecta), * fully erupted teeth exclusion criteria: * absence of teeth selected for the study or that required premolar extractions before starting alignment and leveling * patients with rehabilitation such as crowns, veneers, fractured dentition, atypical morphology * teeth whose bracket loosens at the time of the procedure due to failure of the union * poor oral hygiene * patients with any significant displacement of the tooth that could prevent seating of the transfer tray * study models with bubbles.

Keywords: indirect bonding
roll-over study to collect and assess long-term safety of everolimus in patients with tsc and refractory seizures who have completed the exist-3 study [crad001m2304] and who are benefitting from continued treatment

Conditions: Tuberous Sclerosis Complex

Summary: the purpose of this study is to evaluate the long-term safety in patients with tsc and refractory seizures who are currently receiving everolimus treatment in the novartis-sponsored exist-3 study and who are determined to be benefiting from continued treatment as judged by the investigator at the completion of exist-3

this is a multi-center, open label study to evaluate the long term safety of everolimus in patients with tsc and refractory seizures currently being treated in the novartis-sponsored study exist-3 study and are judged by their parent study investigator as benefiting from the current study treatment. the study is expected to remain open for approximately 10 years (or until 31-dec-2022 in the uk) from first patient first visit (fpfv). patients will continue to be treated in this study until they are no longer benefiting from their everolimus treatment as judged by the investigator or until one of the protocol defined discontinuation criteria is met or everolimus becomes commercially available according to local regulations.

Eligibility criteria:
key inclusion criteria: * patient is currently enrolled in the novartis-sponsored exist-3 study, receiving everolimus, and has fulfilled all its requirements * patient is currently benefiting from treatment with everolimus, as determined by the investigator. * patient has demonstrated compliance, as assessed by the investigator,with the parent study protocol requirements. * patient is willing and able to comply with scheduled visits and treatment plans. * written informed consent/adolescent assent obtained prior to enrolling into the roll-over study. key exclusion criteria: * patient has been permanently discontinued from everolimus study treatment in exist-3 study * everolimus is approved for patients with tsc and refractory seizures and is reimbursed in the local country. * patients who are receiving everolimus in combination with unapproved or experimental treatments for seizure control anti-epileptic drug (aeds) are allowed for the purpose of seizure control.

Keywords: everolimus tuberous sclerosis complex tsc refractory seizure roll over study long term safety pass
mobile health study and enhanced symptom monitoring in covid-19 cancer patients

Conditions: Sars-CoV2; Covid-19

Summary: the established insight(tm) mhealth platform, a component of the stephenson cancer center (scc) mhealth shared resource will be used to create the "symptom tracker" app. the symptom tracker (insight(tm)) app will enable real-time monitoring of cancer patient symptoms that are consistent with early signs of sars-cov-2 infection in this high-risk population by automatically (and securely) transferring this information to health care providers. the primary aim of this study is to determine the feasibility, ease of use, and perceived utility of this app to monitor symptoms and health risk behaviors among cancer patients currently receiving chemotherapy.

a total of 500 treatment-seeking males and females will be asked to complete daily monitoring of symptoms via smartphone app. those who screen positive for covid-19 will be triaged to emergency or non-emergency medical treatment and will receive a study supplied device to measure their oxygen level and heart rate and be instructed in the device's use. they will be prompted to enter vital signs data (such as oxygen level) daily (and as indicated by changes in status) and questions from the app will change to assess the severity of covid-19 related symptoms and inform changes in level of care, to emergency or non-emergency medical management as indicated by self-reporting. the proposed study will assess the impact of heightened symptom and vital sign monitoring on the early identification of severe manifestations of covid-19 in this high-risk population (aim 2). it is hypothesized that this will significantly improve covid-19 related morbidity and mortality compared to the national and international rates currently reported in the literature.

Eligibility criteria:
inclusion criteria: 1. demonstrate \> 6th grade english literacy level (i.e., phone based emas require \>6th grade literacy) 2. present for care at the stephenson cancer center at the university of oklahoma health sciences center 3. are currently receiving systemic chemotherapy by intravenous infusion or by orally delivered medication 4. are greater than or equal to 18 years of age 5. are willing and able to complete surveys on their personal smartphone or a study provided smartphone 6. are willing and able to provide informed consent exclusion criteria: * none
improved diagnostics, treatment and follow-up of acute exacerbation of chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease Exacerbation; Pneumonia; Respiratory Tract Infections

Summary: chronic obstructive pulmonary disease (copd) is a chronic and often progressive pulmonary disease, where inflammation and recurrent infections are key pathophysiological contibutors in disease progression. acute exacerbations of copd (aecopd) are often treated with antibiotics, even though only about 50% are caused by bacteria, and the evidence for benefit of empiric antibiotic treatment in aecopd is conflicting. microbiological sampling is often insufficient in the setting of aecopd, and there is a lack of biomarkers distinguishing aecopd caused by bacteria from those not caused by bacteria, leaving the clinician with few tools to guide the use of antibiotics. overuse of antibiotics is the main driver of antimicrobial resistance (amr), a major global public health threat, and obtaining the correct microbiological diagnose is important in guiding treatment of aecopd. copexnor seeks to examine which samples give the highest microbiological yield in aecopd, comparing induced sputum to nasopharyngeal swabs. we will also compare conventional microbiological diagnostics to modern rapid molecular microbiological tests, to evaluate if faster microbiological diagnosis improves antibiotic stewardship. the study aims to define the microbiological etiology causing aecopd in the norwegian copd-population, and examine the lung microbiome over time. copexnor will explore biomarkers in sputum and blood that can be useful for differentiating patients who will benefit from antibiotic treatment from patients who will not.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * admitted to the emergency room with a tentative diagnosis of aecopd, and at least two of the following criteria, more than the daily variation, * increased dyspnea * increased cough * increased sputum production * need for change in medication due to aecopd * signed informed consent. among patients with temporal or permanent reduced ability to consent, close relatives and/or family members must be asked and may approve or reject participation on behalf of the patient. in cases where close relatives/family members are not available, study personnel may include patients according to conscious judgment. * patients will be informed about the study and included by dedicated and approved study personnel (study nurses or study doctors), not by the treating health personnel. exclusion criteria: * pulmonary embolism, segmental or larger * refractory septic shock (meeting the sepsis-3 definition of septic shock, and requiring vasopressors ≥ 0.5 mcg/kg/min noradrenaline or equivalent dose of other vasopressor(s) * glasgow coma scale score 3 * patients not eligible for lower airways sampling within the first 24 hours of admission * palliative situation with life expectancy \< 1 week
ribavirin for severe acute and chronic hepatitis e virus infection.

Conditions: Hepatitis E

Summary: the purpose of the study is to compare the efficacy, safety and recurrence rate of two therapeutic strategies with ribavirin in patients with chronic hepatitis e and severe acute hepatitis e: fixed duration of treatment for 12 weeks vs variable duration depending on the viremia within 4 weeks of the start of treatment (12 vs 24 weeks). the purpose of the study is also improve the safety of treatment with ribavirin by optimizing dose adjusted to renal function, plasma levels of drug and hemoglobin.


Eligibility criteria:
inclusion criteria: * age equal or greater than 18 years. * to comply with any of the following diagnoses: * chronic hepatitis e: hev rna detectable in patients with elevated transaminase levels for at least 6 months and / or hev rna detectable in two separated determinations by an interval of six months . * severe acute hepatitis e: alanine aminotransferase (alt) levels greater than 10 times the normal limit, with hev rna positive, and signs of acute liver injury (international normalized ratio(inr\> 1.5)); or with extrahepatic manifestations or liver failure in patients with previous liver disease. * signed informed consent exclusion criteria: * terminal illness with a expected life expectancy of less than 6 months * patients with contraindications for treatment with ribavirin: * pregnancy or lactation. * severe hepatic impairment or decompensated cirrhosis. * hemoglobinopathies (thalassemia, sickle cell anemia). * history of severe pre-existing cardiac disease, including unstable heart disease.
post-authorisation safety study in patients with type 2 diabetes to assess the risk of liver injury, kidney injury, urinary tract and genital infections, and diabetic ketoacidosis in patients treated with empagliflozin, compared to dpp-4 inhibitors

Conditions: Diabetes Mellitus, Type 2

Summary: empagliflozin (jardiance), a highly potent and selective inhibitor of the sodium-glucose cotransporter 2 (sglt2), was approved in europe in may 2014 for the treatment of type 2 diabetes mellitus (t2dm) to improve glycaemic control in adults. as part of the risk management plan, boehringer ingelheim international gmbh (bi) has committed to conduct a post-authorisation safety study (pass) to evaluate the liver and renal safety of empagliflozin. the study will also evaluate the risks of severe complications of urinary tract infections (utis) and genital infections. to evaluate the association between empagliflozin use and mentioned outcomes routinely collected health information from the clinical practice research datalink (cprd), the hospital episodes statistics, and office of national statistic will be used. this pass will be conducted through an observational cohort study among adult patients with t2dm and at least 12 months of continuous enrolment in the cprd where new users of empagliflozin will be compared to new users of dipeptidyl peptidase-4 (dpp4) inhibitors. estimations will be made on the crude and adjusted incidence rates and adjusted incidence rate ratios of the primary and secondary outcomes.


Eligibility criteria:
inclusion criteria: * patients will have t2dm, be initiating treatment with a study medication, and have at least 12 months of continuous registration in cprd. * further inclusion criteria apply exclusion criteria: * patients will not have t1dm, will have no prior use of an sglt2 inhibitor or dpp4 inhibitor, and will not be initiating a sglt2-dpp4 fixed-dose combination. * additional different exclusion criteria will be applied according to each outcomes of interest.
data collection protocol for patients with von hippel lindau disease

Conditions: Von Hippel Lindau Disease

Summary: to collect information from patients with vhl disease. information collected will include data on the status of the disease, any surgeries or therapies patients have received for vhl disease, and quality of life.

primary objectives: * obtain prospective and retrospective data on lesion development, surgical history and systemic therapy use in patients with vhl disease * assess genotype-phenotype correlation between vhl mutation type and patterns of lesion development * assess genotype-phenotype correlation for response to belzutifan in an organ-specific manner secondary objectives: --obtain quality of life data in patients with vhl disease

Eligibility criteria:
inclusion criteria: * presence of genetic confirmation or clinical criteria consistent with vhl disease. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: • patients with psychiatric illness/social situations that would limit compliance with study requirements.
non-myeloablative allogeneic transplantation for the treatment of multiple myeloma

Conditions: Blood Cancer; Multiple Myeloma

Summary: mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host disease (gvhd) during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect.

participants are mobilized with cyclophosphamide 4 g/m2 and filgrastim 10 µg/kg/day for peripheral blood progenitor cell (pbpc) collection by apheresis. transplant conditioning is high-dose melphalan 200 mg/m2, followed by pbpc infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (auto-hct)\]. post-infusion support includes filgrastim 5 µg/kg/day, starting 6 days following melphalan. participants with stable or responsive disease at 4 weeks eligible to continue on to the planned allogenic hct (allo-hct). for allo-hct, a sibling donor that is fully matched for human leukocyte antigen (hla-matched) is identified. participants receive a single dose of total body irradiation (tbi) 200 centigray (cgy) as well as immunosuppression with cyclosporine (csp) 6.25 mg/kg and mycophenolate mofetil (mmf) 15 mg/kg. the hla-matched donor begins filgrastim injections 16 µg/kg/day on day -4 continuing to day 0, with apheresis collections on day -1 and day 0, to a target of \> 5 x 10e6 cd34 cells/kg. allo-hct is infused to participant on day 0, with premedication hydrocortisone 100 mg iv and diphenhydramine 50 mg iv. csp will be tapered beginning day 56 with a goal of discontinuing csp on day 180, adjusted as needed.

Eligibility criteria:
patient inclusion criteria * multiple myeloma, early stage ii-iii or relapsed / progression after initial treatment of stage i disease * patient has hla-identical sibling donor * age ≤ 70 years * no prior therapy which would preclude the use of low-dose total body irradiation * pathology review and diagnosis confirmation by stanford university medical center * karnofsky performance status (kps) \> 70% * dlco ≥ 60% predicted * alt and ast \< 2 x upper limit of normal (uln) * total bilirubin \< 2 mg/dl * serum creatinine \< 2.0, or 24-hour creatinine clearance ≥ 60 ml/min * hiv-negative * signed informed consent document patient exclusion criteria * smoldering multiple myeloma; monoclonal gammopathy of unknown significance; or primary amyloidosis * severe psychological or medical illness * prior allogeneic hematopoietic cell transplantation * pregnant or lactating allogeneic donor inclusion criteria * age ≥ 17 * hiv-seronegative * signed informed consent document allogeneic donor exclusion criteria * serious medical or psychological illness * pregnant or lactating * prior malignancies within the last 5 years, except for non-melanoma skin cancers
study evaluating safety and tolerability of meningococcal b rlp2086 vaccine in healthy adults

Conditions: Meningitis, Meningococcal

Summary: the purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal b rlp2086 vaccine in healthy adults.


Eligibility criteria:
inclusion criteria: a subject must meet the following inclusion criteria at screening (visit 1) and at randomization (visit 2) to be considered for enrollment in the study: * male or female subjects between the ages of 18 and 40. * healthy male or female subjects as determined by medical history, physical examination, and judgment of the investigator. * male or female subject who is considered biologically capable of having children must agree to commit to the use of a reliable method of birth control for the duration of the study and for 30 days after early discontinuation. a subject is still biologically capable of having children, even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives. in addition a subject must meet the following inclusion criteria at randomization (visit 2) to be considered for enrollment in the study. the referred blood and urinalysis tests (inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1: * female subjects of childbearing potential with a negative urine pregnancy test prior to study drug administration. note: this criterion will apply to each vaccination visit and to the last study visit. * laboratory blood and urinalysis tests results within the per-protocol normal ranges. * able to be contacted by telephone during the study period. note: this criterion will apply to each study visit. exclusion criteria: none
allogeneic platelet lysate eye drops for the treatment of severe chronic ocular graft-versus-host disease

Conditions: Ocular Graft-versus-host Disease

Summary: the study evaluates the efficacy and safety of allogeneic platelet lysate eye drops in patients with severe ocular graft versus host disease refractory to conventional systemic and local treatments. the corneal staining, conjunctival hyperemia, tear film break up time,schirmer test and ocular surface disease index will be evaluated before and after allogeneic platelet lysate treatment. the safety of allogeneic platelet lysate treatment will be also assessed.

the corneal staining with fluorescein will be assessed using oxford grading scale. tear film break up time is the time in seconds taken to appear first dry sport after complete blinking. fluorescein is instilled into the patient tear film, the tear film is observed under cobalt blue illumination.schirmer test will be performed without anesthesia. conjunctival hyperemia will be graded from 0 to 2. the osdi questinnaire will assess the impact of treatment on the quality of life.

Eligibility criteria:
inclusion criteria: * severe ocular chronic graft-versus-host disease (keratoconjunctivitis sicca) after allo-hsct * schirmer test \< 5mm\\5min * tear film break-up time \< 5sec * corneal staining \> ii gr (oxford grading scale) * ocular surface disease index (osdi) \>30 * resistance to conventional therapy exclusion criteria: * karnofsky \<30% * other concomitant conditions, which does not allow to adequately assess the condition of the eye surface; * acute bacterial, viral or fungal infection of the eyes at the time of screening; * somatic or mental pathology that does not allow you to sign an informed consent; * keratoconjunctivitis sicca associated with an anomaly of the eyelids.

Keywords: chronic graft-versus-host disease ocular dry eye allogeneic stem cell transplantation platelet lysate eye drops