Kornimate/medical-research-clean huggingface dataset:
eptinezumab as an adjunct to standard of care for migraine in an acute emergency context

Conditions: Migraine; Chronic Migraine

Summary: the purpose of the study is to investigate how a medication called eptinezumab (vyepti) given to patients in the emergency department (ed) might help prevent migraines from happening again. the results of this study may help inform better ways to manage patients with migraines in the ed. eptinezumab is currently approved by health canada for the preventive treatment of migraine, but its short-term effectiveness in the ed context is unknown. unlike other migraine treatments used in the ed, eptinezumab can rapidly interrupt the migraine process, potentially also preventing migraine from coming back in the short term. most patients with a diagnosis of migraine have no access to preventative therapies. this study will be able to provide access to preventative therapy at the earliest stages of a migraine attack. administering this medication in the ed may stop the attack more effectively compared to current therapies. this study wants to see if eptinezumab could help stop migraines from coming back after individuals have been treated in the ed. the study will also explore whether eptinezumab could reduce how often individuals with migraine might need to come back to the ed, what other medications they might need alongside eptinezumab, and how they feel overall.


Eligibility criteria:
inclusion criteria: 1. adults between the ages of 19-75 with a history of migraines, as established at the time of presentation to the ed or known from the patient's chart; 2. presenting to the emergency department with a migraine that meets ichd-3 migraine headache criteria; 3. provided signed informed consent; 4. sufficient literacy and cognitive capacity to understand and complete patient self-rated questionnaires in english. exclusion criteria: 1. secondary headaches caused by an injury or underlying illness, such as a concussion, bleeding in the brain, an infection or a brain tumor 2. current or history of severe cardiovascular disease or renal dysfunction 3. a systemic condition in the stage of active treatment (vasculitis, etc.) 4. pregnant or at risk of becoming pregnant (absent contraception) 5. currently enrolled in another investigational drug trial 6. dosed with eptinezumab within the past 3 months 7. currently on anti-cgrp therapy with monoclonal antibodies 8. currently involved in active litigation 9. any other condition which, in the opinion of the investigator, would exclude the participant due to reasons of safety or data integrity 10. hypersensitivity to the active substance or to any of the excipients

Keywords: acute treatment emergency monoclonal antibody
a study exploring two strategies of rivaroxaban (jnj39039039; bay-59-7939) and one of oral vitamin k antagonist in patients with atrial fibrillation who undergo percutaneous coronary intervention

Conditions: Atrial Fibrillation; Percutaneous Coronary Intervention

Summary: the primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one vitamin k antagonist (vka) treatment strategy utilizing various combinations of dual antiplatelet therapy (dapt) or low-dose aspirin (asa) or clopidogrel (or prasugrel or ticagrelor).

this is an open-label (both physician and participant know the treatment that the participant receives), randomized (study medication is assigned by chance), multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and one vitamin k antagonist (vka) treatment strategy in participants, who have paroxysmal, persistent, or permanent non-valvular atrial fibrillation (af) and have had a percutaneous coronary intervention (pci) with stent placement. a target of 2,100 participants will be randomized into the study, with approximately 700 participants in each treatment strategy group. the randomization will be stratified by the intended duration of dapt (1, 6, or 12 months). the study consists of a screening phase, a 12-month open-label treatment phase, and an end-of-treatment/early withdrawal visit. the total duration of participation in the study for each participant is approximately 12 months.

Eligibility criteria:
inclusion criteria: * have a documented medical history of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (af) * have undergone percutaneous coronary intervention (pci) procedure (with stent placement) for primary atherosclerotic disease * must have an international normalized ratio (inr) of 2.5 or below to be randomized * women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active * be willing and able to adhere to the prohibitions and restrictions specified in the study protocol exclusion criteria: * have any condition that contraindicates anticoagulant or antiplatelet therapy or would have an unacceptable risk of bleeding, such as, but not limited to: platelet count \<90,000/microliter at screening, history of intracranial hemorrhage, 12 month history of clinically significant gastrointestinal bleeding, non-vka induced elevated prothrombin time (pt) at screening * have anemia of unknown cause with a hemoglobin level \<10 g/dl (\<6.21 mmol/l) * have a history of stroke or transient ischemic attack (tia) * have a calculated creatinine clearance (crcl) \<30 ml/min at screening * have known significant liver disease or liver function test (lft) abnormalities * have any severe condition that would limit life expectancy to less than 12 months

Keywords: atrial fibrillation irregular heart beat rivaroxaban aspirin clopidogrel prasugrel ticagrelor vitamin k antagonist
medication adherence in patients with liver cirrhosis

Conditions: Medication Adherence

Summary: with this unfunded, investigator-initiated prospective, observational, explorative, single-arm and diagnostic single-centre study the investigators aim to evaluate medication adherence in patients with advanced liver cirrhosis

the main objective of the study is to investigate drug adherence in cirrhotic patients and to gain a better understanding of the causes of deficient adherence including evaluation for medication beliefs, satisfaction, depression, anxiety and health-related quality of life. a number of long-term medications have been approved for this group of patients in various indications and / or recommended by guidelines. however, adherence has not been adequately investigated yet. the investigators aim to focus on the following groups of ingredients / classes: * primary and secondary antibiotic prophylaxis (e.g. norfloxacin) * non-selective beta-blockers (e.g. carvedilol and propranolol) * diuretics (spirolactones \[e.g. spironolacton\], loop diuretics) methodically, this is will be investigated in particular by taking into account the patients history, standardized questionnaires and validated interviews.

Eligibility criteria:
inclusion criteria: * treatment at dept. of gastroenterology, hepatology and endocrinology at med. school of hannover * liver cirrhosis * written consent for the use of personal data and health data for the purpose of this study exclusion criteria: * lack of written consent * no consent ability * lack of literacy * inadequate knowledge of german language
video documented pbs-score in children with clubfoot

Conditions: Clubfoot; PBS

Summary: evaluate agreement and inter-rater reliability of pbs-score assessments based on video documented material.

120 children with idiopathic clubfoot will be included from four different countries 30 patients from each participating center. inclusion criteria include: age 4-14 years, diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in swedish, english, portuguese, urdu, or pashto. all items of the pbs-score will be documented using video recordings. six to eight senior orthopedic surgeons will score a total of 90 children each, not the children from their center of employment, according to the pbs-score based on videos. collaborating centers include karolinska university hospital, sweden, hospital pequeno príncipe, brazil, and hayatabad medical complex, orthopaedic unit, peshawar, pakistan.

Eligibility criteria:
inclusion criteria: * clubfoot exclusion criteria: -
induction chemotherapy followed by concurrent radiation with cetuximab or cisplatin in locally advanced nasopharyngeal cancer

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to compare the efficacy and toxicity of docetaxel-cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin in locally advanced nasopharyngeal carcinoma.

although concurrent chemoradiation is the standard treatment modality for locally advanced nasopharyngeal carcinoma (npc), high incidences of distant metastases and severe treatment related toxicities have become an obstacle to be overcome. a phase ⅱ study conducted by hui et al. showed that neoadjuvant docetaxel-cisplatin (tp) chemotherapy followed by concurrent chemoradiotherapy was superior to the standard concomitant chemoradiation in terms of the 3-year os without significantly exacerbating the acute toxicities. moreover, bonner et al. demonstrated that rt with concurrent cetuximab significantly improved the 5-year os and did not increase the treatment induced toxicities when compared with rt alone. therefore, we initiated this study to compare the efficacy and toxicity of the two regimens, neoadjuvant chemotherapy followed by concurrent radiotherapy with cetuximab or weekly cisplatin for locally advanced npc.

Eligibility criteria:
inclusion criteria: 1. histopathologically proven nasopharyngeal carcinoma (who type 2 or 3) 2. stage ⅲ-ⅳb disease (ajcc/uicc 2009) 3. ecog performance status of 0-1 4. life expectancy of more than 6 months 5. signed written informed consent 6. adequate organ function including the following: * absolute neutrophil count (anc) \>= 1.5 \* 109/l * platelets count \>= 100 \* 109/l * hemoglobin \>= 10 g/dl * ast and alt \<= 2.5 times institutional upper limit of normal (uln) * total bilirubin \<= 1.5 times institutional uln * creatinine clearance \>= 50 ml/min * serum creatine \<= 1 times uln exclusion criteria: 1. evidence of distant metastasis 2. prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5. presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Keywords: nasopharyngeal carcinoma locally advanced cetuximab weekly cisplatin chemotherapy intensity-modulated radiotherapy
efficacy of everolimus as inhibitor of fibrosis progression in liver transplant patients with recurrence of hepatitis c viral infection

Conditions: Recurrent Hepatitis C

Summary: this study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in liver transplant patients who have a recurrence of hepatitis c viral infection in the transplant


Eligibility criteria:
inclusion criteria: * male or female patients 18 - 65 years of age * recipients of deceased or living donors * patients who had undergone primary liver transplantation at least 6 months before enrolment * recurrent hepatitis c viral infection and histologically confirmed liver fibrosis (stage i-iv in the ishak-knodell scale) obtained at baseline or within the previous 6 months to the date of enrolment * patients receiving tacrolimus or cyclosporine micro-emulsion with or without - mycophenolic acid (mpa), with or without steroids. * absence of acute rejection episodes within the previous 6 months to the date of enrolment * patient in whom an allograft biopsy will not be contraindicated * patient willing and capable of giving written informed consent for study participation and able to participate in the study for 24 months * patients with hepatocellular carcinoma (hcc) within the university california, san francisco (ucsf) criteria and no recurrence for at least 18 months after olt. exclusion criteria: * recipients of multiple organ transplants or patients who have undergone retransplantation * current biliary complications * history of drug or alcohol abuse within 1 year before enrolment * patients treated with anti-hepatitis c virus treatment at the time of enrollment or within the previous month to the date of enrolment * co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * patients with leukocyte count (wbc) \< 3000/mm3, platelet count \< 75000/mm3 or hemoglobin (hb) \< 8 g/dl * patients with proteinuria \>1g/24 hours * patient with a current severe systemic infection other protocol defined inclusion/exclusion criteria may apply.

Keywords: fibrosis progression recurrent hepatitis c viral infection liver transplant recipients everolimus hepatitis c recurrence after orthotopic liver transplantation (olt)
the role of biomarkers and echocardiography in prediction of prognosis of chronic heart failure patients

Conditions: Heart Failure

Summary: the bio-shift study aims to investigate whether disease progression in individual patients with chronic heart failure (chf) can be accurately assessed by serial measurements of disease-related (novel) biomarkers. secondary objectives of the study include comparison of 2d- with real-time 3d-echocardiography in chf patients and comparison of speckle tracking with tissue doppler imaging (tdi) in chf patients, and relating these echocardiographic measurements to clinical outcome. bio-shift is a prospective, observational, multi-center, cohort study in men and women, aged 18 years or older, visiting the outpatient clinic. blood samples are taken at the day of inclusion and at follow-up visits, which are performed every 3 months until the end of the scheduled follow-up. clinical data are collected at baseline and at each 3-month follow-up visit. echocardiography including tdi, speckle tracking and 3d-echocardiography is performed in a subset of patients, at baseline and during follow-up at 6-month intervals. the primary endpoint is the composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure.


Eligibility criteria:
inclusion criteria: * men and women, aged 18 years or older, capable of understanding and signing informed consent * diagnosis of chronic heart failure (with diminished ejection fraction or with normal ejection fraction), according to the guidelines of the european society of cardiology (esc) exclusion criteria: * heart failure secondary to circulatory high output conditions * scheduled for surgery or intervention for both coronary and non-coronary indication * severe renal failure for which dialysis is needed * known moderate or severe liver disease * chronic obstructive pulmonary disease (copd) gold stage iv * congenital heart disease * coexistent condition with life expectancy ≤ 1 year * unlikely to appear at all scheduled follow-up visits * linguistic barrier

Keywords: heart failure biomarkers echocardiography
impact program for multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to explore the effects of a four week diet coaching program on pain, fatigue, mood, and dietary habits among adults with multiple sclerosis.

multiple sclerosis (ms) is the most common chronic disabling central nervous system (cns) disease in young adults, affecting 1 in 1,000 people in western countries. disproportionate and unpredictable impacts of co-morbid health conditions enhances the needs for comprehensive ms management and wellness strategies. however, comprehensive care is limited, forcing many people to neglect critical aspects of their wellness. this creates a profound need for health and wellness programs that provide education, connection, and activation. research shows a consistent need for more access to reliable information regarding symptoms, management, access to healthcare professionals, and rehabilitation. there is also a primary unmet need for more information on exercise, nutrition, insurance, transportation, and employment. people living with ms often receive more information from advocacy organizations than their ms nurse or neurologist. decreased access to healthcare professionals since the covid-19 pandemic has heightened the need for credible information from organizations like can do ms. over the past year, can do ms has seen significant growth in virtual program attendance, with participant identifying "learning new information" as a critical objective. a multipronged approach utilizing auditory, visual, and kinesthetic learning styles is the preferred method for delivering information. there is also a need to appeal to multiple sensory channels through complimentary mediums (e.g. video, audio, written materials, tactile activities). we will study the effects of the four week coaching program on dietary patterns in ms patients. this will be done through surveys the participants will complete through qulatrics.

Eligibility criteria:
inclusion criteria: all participants will be adults ages 18 to 65 diagnosed with any form of ms. caregivers are also invited to attend the program if they would like to. no restrictions will be made based on sex, gender or other condition. exclusion criteria: * if the subjects are outside of the age range they will not be able to participate.
cancer patient perspectives during covid-19

Conditions: Breast Cancer

Summary: a web-based survey will be emailed to all adult women diagnosed with invasive breast cancer or ductal carcinoma in situ who have been seen as surgical consultations within the last year (06/01/19-06/01/20).

a web-based survey will be emailed to all adult women diagnosed with invasive breast cancer or ductal carcinoma in situ who have been seen as surgical consultations within the last year (06/01/19-06/01/20). this will ensure that patients at various stages of treatment are included, from initial diagnosis into survivorship. this will allow the investigators to assess changes to initial consultations, surgeries, chemotherapy, and radiation, as well as patient perspectives as it relates to these changes. the web-based surveys will be given via redcap. the study team will use a validated questionnaire developed at the university of miami (penedo, 2020), which includes a combination of multiple-choice questions, likert scale ratings, and yes/no questions. a list of potential questions is listed below. a group of patients will be contacted for semi-structured interviews via telephone as well if (1) patients indicate willingness to participate on a separate redcap survey or (2) if the patient does not respond to this survey. phone interviews will be recorded and transcribed verbatim. multiple members of the research team will separately code the information and evaluate for themes.

Eligibility criteria:
inclusion criteria: * adult females with diagnosis of invasive breast cancer or ductal carcinoma in situ, seen as surgical consultation between 06/01/19-06/01/20 exclusion criteria: * males * patients with non-cancer diagnoses * patients with no history of breast cancer

Keywords: covid-19
preoperative pain threshold and rapid recover programs

Conditions: Knee Arthritis; Hip Arthritis

Summary: to investigate the association between grip strength and preoperative pain threshold as measured by pressure algometer and validated pain outcome surveys.

a minimum of 200 patients, 100 hip and 100 knee arthroplasty participants, will be recruited for this study. preoperatively, patient pain threshold will be recorded both objectively (pressure algometer) and subjectively (brief pain inventory). in terms of location, objectively this will be tested during the preoperative visit in clinic by the approved, trained research staff, as well as the subjective brief pain inventory. objective pain measure: pressure algometer will be obtained in the standard fashion as follows: the probe is applied at a 90 degree angle to the skin at a constant rate of 10kpa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds. the participant is instructed by the measurer to say "stop" when the sensation of pressure became the very first sensation of pain. there will be three spots to test patients, one for familiarity of the testing and the other 2 for data collection. 1. this is initially performed once on ipsilateral the tibialis anterior as a "warm up." 2. then 3 measurements are taken on the operative medial epicondyle (for tka) or ipsilateral lateral iliac crest (for tha) and averaged for the official score. 3. lastly, three measurements are also taken on the contralateral olecranon to measure systemic pain sensitivity. if the contralateral elbow has had prior surgery or active bursitis, the ipsilateral elbow will be used. of important note, the algometer has a max force lock out of 100n to prevent any harm to the patient. 4. dominant hand grip strength measured by the average of 3 attempts on a dynamometer. subjectively, the brief pain inventory is a validated pain outcome measure which will be filled out by the participant during their preoperative clinic visit. postoperative, the study team will ask the participant at the 6 week mark: 1. how many and what kind of opiates did the participant require? 2. how many days did the participant require opiates? 3. did the participant require a refill? a. if so, did the participant have this filled in clinic preemptively or place a phone call to the office?

Eligibility criteria:
inclusion criteria: * any participant undergoing elective primary total knee arthroplasty or total hip arthroplasty * participants of the following investigators will be approached: bolognesi, wellman, attarian, and seyler exclusion criteria: * previous hip or knee surgery in the operative joint

Keywords: knee arthroplasty hip arthroplasty
med-el hearing solutions (mehs): an observational study

Conditions: Hearing Loss

Summary: this registry represents a non-interventional systematic collection of clinical data in which prospective data from children and adults are collected as fully anonymized data sets, derived from original clinical records on appropriately informed subjects. this is a patient-outcomes registry for subjects of any age who are provided in routine clinical practice with one or more med-el hearing devices. the registry aims to collect data for hypothesis generation on subject device use, auditory performance, quality of life and health-related utilities, across different types of implantable and non-implantable hearing devices from med-el company. subjects will be evaluated with a set of standardized tests and questionnaires prior to implantation or prior to initial device activation (baseline) and at follow-up intervals according to the clinical practice.


Eligibility criteria:
inclusion criteria: * for children and adults receiving an implant: subjects submitted or planned to be submitted to unilateral or bilateral implantation, using simultaneous or sequential procedures. * for children and adults receiving a non-implantable device: subjects submitted or planned to be submitted to unilateral or bilateral treatment with a non-implantable device from med-el. * unilateral, bilateral or bimodal users (children and adults) of cochlear implants (cis), electric-acoustic devices, bone conduction implants, middle ear implants or any other implantable or non-implantable hearing solution from med-el. * signed written informed consent for data collection for registry purposes. exclusion criteria: * lack of compliance with any inclusion criteria. * anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the registry procedures