Kornimate/medical-research-clean huggingface dataset:
piloting 'mpal,' a multilevel strategy for palliative care implementation

Conditions: Lung Cancer

Summary: the purpose of this study is to assess the feasibility and acceptability of mpal, a multilevel implementation strategy to improve palliative care use among advanced stage lung cancer patients receiving cancer treatment.

in this study, 60 advanced stage lung cancer patients will be randomized to mpal's patient-level component or usual care. oncology providers will receive the mpal intervention. mpal is designed to help oncology providers integrate outpatient palliative care (non-hospice palliative care; nhpc) into routine clinical practice through: 1) electronic health record enhancements; 2) patient education and preparation for nhpc discussions when patients are in clinic to see their oncology providers; and 3) provider education about nhpc. this study will examine the feasibility and acceptability of mpal and gather preliminary data on potential outcomes for a future effectiveness trial.

Eligibility criteria:
inclusion criteria: * new or recurrent ajcc stage iiib-iv non-small cell lung cancer or extensive stage small cell lung cancer * ecog performance status 0-3/karnofsky 40-100 * at least three weeks into active oncologic treatment (chemotherapy, immunotherapy, chemo-immunotherapy) exclusion criteria: * unstable brain metastases * cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which participating would be inappropriate * receiving palliative care * unable to speak and read english

Keywords: palliative care
a study to evaluate chronic hepatitis c infection in adult transplant recipients

Conditions: Chronic Hepatitis C Infection

Summary: the purpose of this study is to evaluate the safety and efficacy of abt-450/r/abt-267 with or without abt-333 and with or without ribavirin (rbv) in adult liver or renal transplant recipients with hepatitis c virus (hcv) genotype 1 or 4 (gt1 or gt4) infection.


Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age at the time of screening. * currently taking an immunosuppressant regimen based on either tacrolimus or cyclosporine. corticosteroids such as prednisone or prednisolone are permitted as components of the immunosuppressant regimen providing the dose is not more than 10 mg/day. * hepatitis c virus (hcv) interferon (ifn) therapy treatment-naïve or -experienced, either pre- or post-liver or renal transplant. * screening hcv genotype testing indicating infection with genotype 1 or 4 (gt1 or gt4) only. exclusion criteria: * use of everolimus or sirolimus as part of the immunosuppressive regimen within 2 months of screening visit. * use of any medications contraindicated for use with the study regimen as well as those that are contraindicated for use with either ritonavir or ribavirin within 2 weeks prior to study drugs administration or 10 half-lives (if known), whichever is longer. * positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab). * documented history of post-transplant complications directly involving the hepatic or renal vasculature as appropriate to the organ transplanted, e.g., thrombosis of the portal vein, the hepatic artery and/or hepatic vein. * clinically significant abnormalities, other than hcv infection, in a subject post-transplant based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ecg) that make the subject an unsuitable candidate for this study in the opinion of the investigator.

Keywords: hepatitis c genotype 4 chronic hepatitis interferon-free hepatitis c virus (hcv) renal transplant liver transplant hepatitis c genotype 1
the bilirubin levels in cerebrospinal fluid of spontaneous subarachnoid hemorrhage patients

Conditions: Spontaneous Subarachnoid Hemorrhage

Summary: according to morgan et. al. (j neurosurg 101:1026-1029, 2004): bilirubin as a cerebrospinal fluid marker of sentinel subarachnoid hemorrhage: a preliminary report in pigs, we're going to test the hypothesis in the cerebrospinal fluid of spontaneous subarachnoid hemorrhage patients.

according to morgan et. al. (j neurosurg 101:1026-1029, 2004): bilirubin as a cerebrospinal fluid marker of sentinel subarachnoid hemorrhage: a preliminary report in pigs, we're going to test the hypothesis in the cerebrospinal fluid of spontaneous subarachnoid hemorrhage patients. we'll collect the serial cerebrospinal fluid in 15-20 spontaneous subarachnoid hemorrhage patients to see the time sequence of changes in bilirubin levels.

Eligibility criteria:
inclusion criteria: * spontaneous subarachnoid hemorrhage in less than three days exclusion criteria: * spontaneous subarachnoid hemorrhage more than three days
video capsule examination in patients with lynch syndrome

Conditions: Lynch Syndrome; Li Fraumeni Syndrome; PTEN Hamartoma Syndrome; FAP; MUTYH Biallelic Mutation; STK11 Mutation; CDH1 Gene Mutation; CHEK2 Gene Mutation; BMPR1A Gene Mutation; SMAD4 Gene Mutation

Summary: surveillance for colorectal cancer (crc) in patients predisposed to develop crc during their lifetime has been impacted by access to colonoscopy suites and endoscopy specialists in the past couple of years. an alternative method, namely the colon capsule, has been proposed, however this investigation is time consuming for the clinician and the images require up to one hour (30-60 minutes) reading to issue a result. the investigators propose to obtain images from paired colonoscopies and colon capsules with the purpose of developing an ai algorithm which could aid the clinicians in reading the colon and expand access to this investigation. the main aim of the study is to determine whether it is possible to obtain usable paired images from patients with lynch and other cancer predisposition syndromes. this will depend on the willingness of the patients to take part in the study and the technical ability of obtaining data from paired images of colonoscopies and colon capsule. at recruitment, participants will undergo a colon capsule investigation, followed by a routine colonoscopy as per their normal standard of care. paired endoscopic images from colonoscopies and colon capsules will be collected and anonymised data will be accessed by the bioinformatician for analysis. if the study will be successful in reaching the primary endpoint, further trials will be opened, allowing for a larger population to be included and to obtain more robust data, which eventually can lead to validated ai algorithms and application of computer-aided video-capsules examination as a screening tool in at-risk population.


Eligibility criteria:
inclusion criteria: * patients over the age of 18 years old with no active cancer * no previous resection of the colon and/or rectum * carriers of a pathogenic/likely pathogenic variant in any of the following cancer-predisposition genes: lynch syndrome (mlh1, msh2, msh6, pms2), apc (fap syndrome); biallelic mutyh; stk11 (peutz-jeghers syndrome); pten, cdh1, chek2, tp53, bmpr1a and smad4 (juvenile polyposis syndrome) * able to consent to the study and undergo colonoscopy. exclusion criteria: * extensive surgery which poses a high risk of video-capsule blockage or narrowing of the bowel due to extensive tumour. extensive surgery implies any removal of large portions of the small or large bowel that might cause a narrowing (stricture) in the digestive tract. * previous irradiation to abdomen or pelvis (risk for small bowel obstruction) * carriers of a variant associated with reduced penetrance (in the view of a geneticist) or a variant of uncertain significance. * patients with a ps of 3 or 4 and/or mobility issues * pregnancy * pacemaker or internal electro-medical device (artificial heart valve, cochlear implant or an internal electromedical device). * insulin-dependent diabetes * patients who require deep sedation for colonoscopy
the impact of maternal sound on awareness for pediatric patients undergoing cardiac surgery

Conditions: Intraoperative Awareness

Summary: awareness during anesthesia with intraoperative memory occurs when the patient is able to process information and produce specific responses to several stimuli. anecdotal evidence suggests that children exposed to therapeutic suggestion consisting of gently encouraging, positive words spoken to them during emergence from anesthesia seem to arouse after surgery with less agitation, less pain and lower requirements for pain medications. therapeutic suggestion has been associated with positive results in some adults during surgery, but it is unknown how therapeutic suggestion affects children. a newborn's recognition and preference for their mother's voice occurs early in life, very likely during fetal development. additional evidence, revealed that at least as early as 4 months of age, infants process auditory stimuli from their mother's voice at a higher amplitude than they process auditory input from female strangers, suggesting that maternal voice stimuli undergo a unique form of cerebral processing that lends support for the existence of neurophysiologic mechanisms that reflect a child's preference for his/her mother's voice. this study aims to evaluate and compare the possibility of intra-operative awareness prevention by using either music listening or maternal sound listening in children undergoing cardiac surgery.

children (4 to 8 years) undergoing repair of atrial septal defect (asd). patients will be randomized into two groups (music group and maternal sound group); in music group patients listened to a recorded cd by music and songs preferred by the child, while in maternal sound group patients listened to a recorded cd where the mother singing the most popular songs their children like or telling a story to their children. in both groups bi spectral index (bis) to detect depth of anesthesia. an interview will be conducted with the patients and their parent within the first postoperative week by a semi-structured in-depth questionnaire to evaluate occurrence of awareness.

Eligibility criteria:
inclusion criteria: * patients in the age range 4-8 years scheduled for elective cardiac surgery for atrial septal defect (asd) repair with cardiopulmonary bypass exclusion criteria: * patients with previous cardiac surgery, diabetes mellitus, hearing impairment and psychiatric or neurological illness were excluded from this study.

Keywords: awareness cardiac surgery maternal pediatric sound music
role of circulating innate lymphoid cells in allergic disorders

Conditions: Allergy; Asthma; Urticaria

Summary: this study evaluates blood type 2 innate lymphoid cells in participants with mild to moderate asthma and participants with chronic urticaria as compared to healthy adult participants.

the first objective of this study is to determine whether blood ilc2s differ in female vs. male allergic asthmatics. this is because females become more susceptible to asthma after puberty and experience more severe disease as adults. the second objective of this study is to determine whether ilc2 cells in chronic urticaria differ from healthy controls. there will be one shared healthy control adult subject group for comparison for objective 1 and 2. in this study, there will be a blood draw once on 3 different adult populations aged 19-50 years: 1) participants with mild-to moderate allergic asthma; 2) participants with chronic urticaria, and 3) healthy control adult participants. demographics and allergy indicators will be collected from the medical chart. the investigators will acquire whole blood for serum and acquisition of specific lymphocyte populations. there will be no intervention or research follow up.

Eligibility criteria:
inclusion criteria: 1. adult subjects between age 19-50 years. 2. non-smokers, defined as \< 100 cigarettes in lifetime. exclusion criteria: 1. female donors will be excluded if they are menopausal or have undergone total abdominal hysterectomy and/or bilateral salpingoophorectomy 2. for female donors, blood draw cannot occur during menstrual period time. subjects will be excluded if they have menstrual period at timing of blood draw. 3. current and past smokers. 4. subjects with asthma and any other lung disease including chronic obstructive pulmonary disease, interstitial lung disease, pulmonary hypertension, sarcoidosis, cystic fibrosis. 5. pregnant or lactating subjects 6. subjects with hypercalcemia (\> 10.3 mg/dl), renal insufficiency (glomerular filtration rate \[gfr\] \< 50 ml/min/1.73m2), or malignancy. 7. subjects with any symptoms of respiratory infection in the past 4 weeks. 8. subjects unable to hold leukotriene modifiers or antihistamines for at least 24 hours prior to blood draw. 9. subjects on any immunomodulators, including omalizumab, or systemic corticosteroid in the past 4 weeks.

Keywords: allergy asthma urticaria
sildenafil citrate in waldenstrom's macroglobulinemia

Conditions: Waldenstrom's Macroglobulinemia

Summary: the purpose of this study is to determine the effects (good or bad) that sildenafil (viagra) has on patients with slow growing waldenstrom's macroglobulinemia (wm). sildenafil blocks the function of several proteins necessary to the survival of certain types of cancer and laboratory tests have shown that it can destroy wm cells.

* sildenafil will be given orally (at home) at a reduced dose for the first week, then each week for 3 more weeks, the dose will be increased. if the patient has no major side effects, then they will receive the maximal dose for 2 years. if they have major side effects, then the dose of the drug might be lowered or the drug stopped. * sildenafil will be continued until their is disease progression or serious side effects. * while patients are receiving sildenafil, they will be seen in the clinic on months 1,2,9,15 and 21 for blood tests and a subject questionnaire. they will also be seen on months 3,6,12,18 and 24 for a physical exam, blood test, physical assessment test, ct scans of chest, abdomen and pelvis, and a subject questionnaire. * at the end of the study (month 24) a physical exam, blood tests, physical assessment test and a questionnaire will be conducted. * follow-up includes clinic visits at month 27,33,39 and 45 for blood tests and a questionnaire as well as visits at month 30,36,42 and 48 for physical exam, blood tests, physical assessment test, bone marrow aspirate and biopsy, ct scans of chest, abdomen and pelvis, and a questionnaire.

Eligibility criteria:
inclusion criteria: * clinicopathological diagnosis of waldenstrom's macroglobulinemia * measurable disease, defined as presence of immunoglobulin m (igm) paraprotein with a minimum igm level of \> 2 times the upper limit of each institution's normal value * slowly progressing disease not requiring therapy for at least 3-6 months * ecog performance status 0,1 or 2 * total bilirubin \< 2 x uln * sgot \< 3 x uln * creatinine \< 2 x uln exclusion criteria: * pregnant or breast-feeding women * patients who are using organic nitrates or alpha-blockers * grade iii/iv cardiac problems * resting hypotension (bp \ 170/110) * cardiac failure or coronary artery disease causing unstable angina * evidence of left ventricular outflow obstruction * impaired autonomic control of blood pressure * sickle cell anemia * history of priapism * severe and/or uncontrolled medical disease * known chronic liver disease * currently using ritonavir * history of retinal pigmentosa

Keywords: sildenafil citrate viagra waldenstrom's macroglobulinemia
ibd-opera database, uc protocol

Conditions: Inflammatory Bowel Disease

Summary: the investigators believe that patients with ulcerative colitis are able to report details of their own medical history accurately and record changes in clinical status effectively over time. using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.


Eligibility criteria:
inclusion criteria: * md documented diagnosis of ulcerative colitis * current of past prescription for anti-tnf medication * at least 18 years of age * access to medical records to verify information * 20% of participants will be patients diagnosed within 1 year of inclusion exclusion criteria: * unwilling or unable to provide informed consent for study participation * unable to access or use internet * less than 18 years of age * diagnosis of crohn's disease or ibd-u * illiterate or does not possess minimum level of literacy required to complete questionnaire

Keywords: ulcerative colitis
differential effects of dual antiplatelet and dual antithrombotic therapy on hemostasis in chronic coronary syndrome patients

Conditions: Thrombosis; Myocardial Infarction

Summary: the investigators will be comparing the effects of two different drug treatment strategies, in patients with history of a heart attack, on different markers of bleeding and clotting risk. both treatment strategies are already approved for the indication of improving outcomes in high-risk patients with history of heart attack.

the investigators will enroll patients with coronary disease \>1 year after an acute coronary syndrome. subjects will be randomized to one of two treatment plans. one plan the participant will take ticagrelor for one week, then take two weeks off with no drug (washout period), then one week of rivaroxaban. the other plan will be reverse order where the participant will take rivaroxaban for one week, then two weeks off(washout period), then one week of ticagrelor. study drugs will be provided to participants at the start of each treatment period. bleeding time will be determined and blood samples will be taken at four timepoints (baseline, post first drug, pre second drug, and post second drug) to measure complete blood count, crp, and fibrin clot assessment. these are surrogate markers for safety (bleeding) and efficacy (increased thrombotic risk)

Eligibility criteria:
inclusion criteria: * patients with chronic coronary syndrome (at least 1 year after having a myocardial infarction) on aspirin monotherapy will be eligible for this study. they have to have at least one of these additional risk factors: 1. diffuse coronary artery disease. 2. peripheral vascular disease 3. diabetes 4. chronic kidney disease (egfr\<60 ml/unit/1.73 m2) exclusion criteria: * allergy to either rivaroxaban or ticagrelor * requirement for anticoagulation or p2y12 inhibitor therapy * anemia (hemoglobin \< 10 g/dl) * severe renal impairment (egfr \< 30 ml/unit/1.73 m2) * bleeding disorders * significant liver impairment resulting in deranged clotting parameters * any history of intracranial hemorrhage * stroke within 6 months * history of gastrointestinal bleed within 6 months * major surgery within 1 month * patients with inflammatory conditions * concomitant treatment with immunosuppressive therapy, inhibitors or inducers of p glycoprotein or cyp3a4 enzymes (eg. azole antifungals, ritonavir, erythromycin, clarithromycin, rifampicin) * concomitant treatment with antidepressants (selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors) * pregnancy * inability to give written consent
effects of n-3 polyunsaturated fatty acids and antioxidants on postprandial hyperlipidemia and vascular function in men

Conditions: Cardiovascular Diseases; Vasodilation

Summary: diet has long been used as a way to provide enough nutrients to an individual in order to meet metabolic requirements. however, recent scientific advancements have suggested that beyond meeting nutrition needs, diet may also be health promoting through the modulation of various body functions. in a way, the role of nutrition has evolved from hunger satisfaction and maintenance of body integrity to the promotion of a state of well-being and prevention of important chronic diseases such as cancer, diabetes and cardiovascular disease (cvd). in recent years, n-3 polyunsaturated fatty acids (pufa) have attracted much attention as consumption of a n-3 pufa rich diet has been reported to reduce cvd risk. however, n-3 pufa are also highly susceptible to free radical damage and therefore could be unable to fully exert their health benefits under an oxidative stress condition. the general objective of the present application is to investigate the mechanisms by which n-3 pufa improve cardiovascular health in abdominal obesity and explore the potential of dietary antioxidants to modulate these effects in individuals at high risk of oxidative stress. for that purpose, we plan to study the changes in fasting and postprandial plasma lipoprotein-lipid levels, markers of lipid and lipoprotein oxidation, inflammation and endothelial dysfunction following 12 weeks of n-3 pufa supplementation with or without low-calorie cranberry juice cocktail (as a source of antioxidants) in a group of 160 men. we feel that the present study will broaden our understanding of the physiological mechanisms underlying the beneficial effects of consuming unsaturated fatty acids and give further insights on the role of antioxidants in preserving and potentiating these cardiovascular health benefits.


Eligibility criteria:
inclusion criteria: * waist circumference \> 90 cm * fasting triglycerides \> 1.7 mmol/l * no use (ever) of medications for the treatment for dyslipidemia or hypertension exclusion criteria: * alcohol consumption \> 1 drink per day i.e \~15 g of alcohol/day or the equivalent of 1 beer (12 oz or 341 ml), 1 glass of wine (4 oz or 125 ml) or 1 ounce (30 ml) of liquor. * chronic use of supplements (vitamins, minerals or flavonoids) * body mass index \> 35 kg/m2 * chronic diseases: chd, diabetes, etc. * smokers (1 or more cigarette/day) * dyslipidemia secondary to renal insufficiency, hypothyroidism or others * any prior or current use of medications known to affect lipoprotein-lipid metabolism (e.g. statins, fibrates), endothelial function (hypotensive drugs). use (ever) of anticoagulant drugs (e.g. warfarin) because of possible detrimental interaction with the consumption of cranberry juice. current or recent (\<2 weeks) use of anti-inflammatory drugs note: if for any reason, a subject would have to go an any of these drugs during the protocol, they would be automatically dropped from the study.
open, pharmacokinetic study of caspofungin in neonates and infants (0991-058)

Conditions: Candidiasis

Summary: the purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants \<3 months of age following treatment with caspofungin at 25 mg/m2. another purpose is to test the safety of caspofungin in treating neonates and infants with candida infections (a certain type of fungal infection).


Eligibility criteria:
inclusion criteria: * neonates and infants \<3 months of age * patient has a body weight greater than or equal to 500 grams * patient has documented or highly suspected candida infection exclusion criteria: * patient is greater than 3 months of age * patient has a body weight of less than 500 grams * patient does not meet certain laboratory testing criteria * patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days * patient has documented hiv infection of any stage * patient has a history of allergy, hypersensitivity, or serious reaction to caspofungin or another member of the echinocandin class