Kornimate/medical-research-clean huggingface dataset:
changing health behaviors to manage chronic conditions in community-dwelling african american breast cancer survivors

Conditions: Breast Cancer Female; Survivorship

Summary: the purpose of this project was to test the efficacy of partnering with a community-led wellness program to reduce disease risk and increase wellness among breast cancer survivors. information gathered will serve the dual purpose of testing intervention effectiveness and providing the community organization data to be used to secure sustainability funding

social and environmental issues continue to impact disease morbidity and mortality resulting in the inequities of health, wellness, and quality of life experienced by african american breast cancer survivors (aabcs) living in urban milwaukee. aabcs outcomes in milwaukee are significantly worse (or=1.55) than those of caucasian survivors. the american diabetes association/american cancer society expert committee recommends the promotion of a healthy diet, physical activity, and weight management with low waist circumference to prevent diabetes, cancer, and obesity and to extend life expectancy. according to the national health interview survey, 56% of african americans are inactive. yoga is one way to increase physical activity while improving wellness and health in aabcs. the investigator's goal was to facilitate improved self-care efficacy through evidence-based integrative health and wellness strategies to help families overcome the effects of multiple negative, deep-rooted social determinants.

Eligibility criteria:
inclusion criteria: * sex: female * race: african american * survivor of breast cancer * physical activity participation not limited by medical doctor * english speaking exclusion criteria: * sex: male * race: not african american * no breast cancer history * physical activity limitations imposed by medical doctor
study of non-invasive regional oxygen saturations in pediatric patients undergoing cardiac catheterization

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to validate the nonin near-infrared spectroscopy (nirs) device to measure regional oxygen saturation in a cohort of children with cardiovascular disease undergoing cardiac catheterization.


Eligibility criteria:
inclusion criteria: * the subject is male or female; * the subject is of any racial or ethnic group; * the subject is between 0 days and 12 years of age; * is less than 40 kg; * the subject is scheduled for a cardiac catheterization for treatment or diagnosis of a cardiovascular disease; * the scheduled cardiac catheterization includes catheter placements in the central venous circulation and central arterial circulation, or catheter placement in the central venous circulation with a pre-existing arterial catheter; * the subject is american society anesthesiologist (asa) status 1 through 4; and * the subject's legally authorized representative has given written informed consent to participate in the study and, when appropriate, the subject has given assent to participate. exclusion criteria: * is greater than twelve (12) years of age; * has pre-existing allergies to adhesive tapes or adhesives on neonatal ecg pads; * has pre-existing skin condition at the site where the nonin cerebral oximeter sensor will be placed (e.g., eczema, dermatitis); * has craniofacial disease preventing application of the sensor to the forehead; * has sickle cell anemia or other hemoglobinopathy; * has disease of the cerebrovasculature including the jugular or carotid vessels; * was previously on ecmo involving the carotid or jugular vessels that could have resulted in disease or ligation; * is not able to be in a supine position with cardiac catheterization laboratory table angle zero degrees with a neutral neck position at zero degrees rotation; * has acute neurological injury (seizure, stroke, encephalopathy, meningoencephalitis currently or within the past 10 days), or a structural brain lesion (eg, arteriovenous malformation, cyst) in the optical field beneath the sensor; * has an emergency, life-threatening condition (american society of anesthesiologists physical status 5 or 6) impacting the ability to obtain informed consent; * or has another condition, which in the opinion of the principal investigator would not be suitable for participation in the study.

Keywords: near-infrared spectroscopy (nirs) regional oxygen saturation pediatrics cardiac catheterization congenital heart disease
biomarkers in blood and tissue samples from patients with newly diagnosed neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research trial studies biomarkers in blood and tissue samples from patients with newly diagnosed neuroblastoma.

objectives: * determine the expression of neuropeptide y (npy) and its receptors (rs) in human neuroblastoma (nb) tissues. * determine whether bdnf/trkb and trkaiii stimulate expression of npy and its rs. * determine whether npy mediates bdnf- and trkaiii-induced nb proliferation and survival. * determine neurotrophins' angiogenic actions. * identify factors released from nb cells upon npy stimulation (proteomics). * determine whether npy upregulates expression of the identified proteins in nb and their rs in endothelial cells (ecs). * test whether inhibition of the identified pathways reduces angiogenic activity of nb-conditioned media. * determine the mechanisms of nyp actions and signaling pathways. * test whether blocking npy-y2/y5 pathway reduces nb growth and vascularization in vivo. outline: archived tumor tissue and serum samples are analyzed for neuropeptide y and its receptors (y1, y2, and y5) expression, neuroblastoma prognostic factors (mycn, trka, trkaiii, trkb, bdnf, and ngf), and angiogenic markers by real-time pcr, ihc, elisa, radioimmunoassay (ria), mitogenic assay, caspase 3/7 activity assay, western blots, liquid chromatography, tandem mass spectrometry, proteomic assays, and other assays. results are then analyzed and compared with patients' clinical data, including stage of disease, its phenotype, prognostic markers, age and gender, and response to treatment.

Eligibility criteria:
disease characteristics: * children with newly diagnosed neuroblastoma or ganglioneuroblastoma * samples from the children's oncology group (cog) from patients enrolled in clinical trials in institutions in the usa, canada, and australia * paraffin-embedded tumor specimens, rna isolated from tumor tissues, and patient serum must be available patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: disseminated neuroblastoma localized resectable neuroblastoma localized unresectable neuroblastoma regional neuroblastoma stage 4s neuroblastoma
prospective cohort study for validation of predictive immune biomarkers of response to papr inhibitors

Conditions: Ovarian Cancer

Summary: increasing number of ovarian cancer patients are receiving parp inhibitor as maintenance therapy. predictive factors to parp inhibitor other than brca mutation or hrd status are unknown. previous study, we analyzed the dynamic immunological changes in peripheral t cells during parp inhibitor maintenance therapy and found predictive biomarkers. the purpose of this study is to prospectively validate the biomarkers for predicting response to papr inhibitors in ovarian cancer. we collect serial blood samples (before initiation of therapy and after 1, 3, and 6 months) in ovarian cancer patients who receive parp inhibitor and analyze immunological characteristics of peripheral cd8 and regulatory t cells. through assessment of the baseline properties and dynamic changes in t cells, we aim to validate the predictive biomarker and develope promising novel targets to enhancing survival outcomes of high-risk patients.


Eligibility criteria:
inclusion criteria: 1. pathological diagnosis of epithelial ovarian cancer, 2. presence of germline or somatic brca mutational status result, 3. advanced or recurrent ovarian cancer patients who responded to their most recent platinum-based chemotherapy and plan to start parpi (olaparib or niraparib) maintenance therapy. exclusion criteria: 1. patients who refuse to participate, 2. patients having difficulty understanding the protocol due to language barrier
motivational interviewing to promote maintenance of physical activity in people with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to assess the effectiveness of motivational interviewing in promoting maintenance of physical activity in people with type 2 diabetes (t2d) upon the completion of a structured exercise program. participants with t2d who are new graduates of a supervised exercise program will be randomly assigned to either standard care (sc) or to standard care and in addition, participate in two individual motivational interview (mi) sessions (sc + mi). the primary outcome will be change in physical activity behavior assessed by the godin leisure and exercise questionnaire. secondary outcomes will include change in blood glucose control (a1c), bmi, six minute walk-test, qol, and self-efficacy. outcomes will be measured in groups at baseline, end of program, 3 months and 6 months post-program.


Eligibility criteria:
inclusion criteria: * a) self-reported physician diagnosed t2d, included are those who are treated with diet alone, oral medication and insulin * b) clearance by living well clinical staff to exercise through gxt algorithm and triaged to "keep going" level class, * c) at least 18 years of age, * d) ability to read and write in english. exclusion criteria: * a) insulin therapy that began less than 2 years after t2d diagnosis, * b) changes during the previous 2 months in oral hypoglycemic

Keywords: type 2 diabetes, motivational interviewing, physical activity maintenance, physical activity adherence
tailored drug titration through artificial intelligence

Conditions: Hypertension

Summary: artery is a randomized clinical trial that investigates the benefit of a predictive modeling artificial intelligence in improving the management of anti-hypertensive medication treatment.

the goal of the proposed research is to test a connected medication management platform technology to address medication optimization and non-adherence in chronic disease management. chronic diseases (such as hypertension, heart failure, diabetes, coronary disease, etc.) are the main causes of morbidity, mortality and healthcare expense in the united states. poor medication adherence and mismatches in the treatment (due to patient's reported side effect, complexity of treatment, and suboptimal efficacy of a chosen pharmacological treatment) are a major reason of failure in the management of chronic disease. the platform tested in this award will evaluate a complex machine-learning algorithm in treatment optimization for one of the chronic conditions, namely hypertension. the results of the proposed randomized clinical trial, if successful, will lead to a change in the treatment paradigm for chronic diseases. the principal investigator has just completed a pilot study in conjunction with optima inrwgrated health, inc. (i.e. precision) to successfully test the medication management platform technology and its integration with the electronic medical record (epic® platform). optima-for-blood pressure (o4bp) is a cloud-based artificial intelligence clinical decision support system (cdss) that evaluates patient status updates in real-time to provide advanced decision recommendations for medication treatment changes, when needed, personalized to each patient. o4bp provides a multiparameter (age, gender, ethnicity, current treatment, comorbidities, side-effects, laboratory values, compliance) overall score computation that ranks possible treatment changes in order of % improvement over current treatment. the goal of the study is to test if blood pressure management by using the o4bp cdss is superior to standard of care (soc) (i.e. blood pressure management during office visits).

Eligibility criteria:
inclusion criteria: * two or more blood pressure readings of ≥ 150/95 mmhg during primary care office visits in the department of general medicine within the last 6 months * therapy with medications from at least 1 anti-hypertensive pharmacological agents at the time of the last office visit * at least minimally "tech-savvy" defined as ownership of a compatible smartphone ability to access the internet exclusion criteria: * inability to operate a blood pressure cuff * incompatible smartphone device (galaxy s5 android 5.0) * less than minimally "tech-savvy," defined as inability to use the internet * non-compliance with medical follow-up (frequent "no shows") * planned coronary revascularization in the next 12 months * myocardial infarction, coronary revascularization, stroke, cardiac or aortic surgery in the previous 90 days * gfr \< 30 (ckd stage iv/ v) * primary care provider rules out the patient due to comorbidities or other factors
an open-label, multi-center, international, three-year, safety and tolerability 'follow on' trial

Conditions: Type 2 Diabetes Mellitus

Summary: safety follow-up trial to pdc-ins-0008 and mkc-ti-005

this is an uncontrolled study without comparator. subjects were followed up to 4 years on technosphere insulin. of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥ 36 mo, 31 for ≥ 42 mo, \& 2 for 48 mo.

Eligibility criteria:
inclusion criteria: * previous completion of pdc-ins-0008 or mkc-ti-005 * subjects must be able to attend all scheduled visits and, in the opinion of the investigator, be able to complete this safety trial * subjects must be able to understand english or have access to validated primary language trial documents * written informed consent exclusion criteria: * drug or alcohol dependency * smokers (subjects are expected to remain non-smokers throughout their participation in this trial) * known hypersensitivity to the trial drug or to drugs of similar chemical structures * anemia (hemoglobin level \< 11 g/dl for females or \< 12 g/dl for males) * evidence of moderate or greater ketones in urine * women of childbearing potential practicing inadequate birth control. (adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermicide, intrauterine devices, depo-provera, contraceptive patches or surgical sterilization) * women who are pregnant * clinically significant adverse events that remain unresolved from the previous trial and/or clinically significant abnormal laboratory values which are determined by the investigator or the mkc medical monitor to be unsafe or confounding to continued participation
somatostatin prevent post-operation pancreatic fistula in intermediate risk patients after pancreaticoduodenectomy

Conditions: Pancreatic Fistula

Summary: this study is designed to assess the preventive effects of somatostatin on post-operation pancreatic fistula in intermediate risk patients after pancreaticoduodenectomy. patients assigned into the treatment group will be continuous intravenous infusion with the somatostatin (stilamin®) in addition to conventional treatments (including infection prevention, nutrition support and acid suppression therapy, etc.).the pancreatic fistula incidence will be monitored within 30 days after operation.

this is a multi-center randomized, controlled clinical trial. a total of 200 patients are expected to be recruited. each trial center recruits subjects based on the sequential principle and inspect the inclusion and exclusion criteria after pd and subjects meeting the standard are assigned randomly to the treatment group or control group. apart from conventional treatments (including infection prevention, nutrition support and acid suppression therapy, etc.), the treatment group will be continuous intravenous infusion with the somatostatin (stilamin®) of 250μg/h for 120h (total dose of 6mg/day x 5 days=30mg), beginning within 3 hours after the operation; the control group will accept conventional treatments other than the stilamin. the pancreatic fistula incidence, biochemical leak incidence, morbidity and number of other complications related to the pancreatectomy, length of stay in hospital, hospitalization cost, re-admission rate and re-operation rate will be monitored within 30 days after operation. subjects will be visited for 5 times from the start to the end of the study. statistical methods:number of patients who had pancreatic fistula after surgery will be analyzed using chi-square test.secondary endpoints: continuous variates will be described as mean± sd; attempted to be analyzed using analysis of variance. categorical variates will be described as rate; attempted to be analyzed using chi-square test.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 year 2. patients underwent pancreaticoduodenectomy 3. fistula risk score recommended by isgps is intermediate risk 4. inform consent obtained exclusion criteria: 1. pervious pancreatic surgery history 2. received somatostatin or analogues treatment less than 5 half-life periods before surgery 3. known allergy to somatostatin or mannitol 4. woman who is pregnant, plan to be pregnant or during lactation period 5. attended other clinical trials within 30 days 6. all contraindications to somatostatin (stilamin®) 7. patients with any serious disease that investigator considers he/she should be excluded

Keywords: somatostatin pancreatic fistula intermediate risk pancreaticoduodenectomy
a tolerability study of alks 8700 in subjects with relapsing remitting multiple sclerosis (rrms) evolve-ms-2

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the objectives of this study are to evaluate the utility of two gastrointestinal (gi) symptom scales (individual gi symptom and impact scale {igisis} and global gi symptom and impact scale {ggisis}) in assessing gi tolerability in adult subjects with rrms after administration of alks 8700 or dimethyl fumarate (dmf) in part a, to compare the gi tolerability of alks 8700 and dmf in adult subjects with rrms using igisis and ggisis in part b, and to evaluate the safety and tolerability of alks 8700 in adult subjects with rrms in parts a and b.


Eligibility criteria:
key inclusion criteria: * capable of understanding and complying with the protocol * has a confirmed diagnosis of rrms * neurologically stable with no evidence of relapse within 30 days prior to randomization * agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration, or is surgically sterile or post-menopausal key exclusion criteria: * have any finding(s) that would compromise the safety of the subject, affect the subject's ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study * diagnosis of primary progressive, secondary progressive, or progressive relapsing ms * history of clinically significant cardiovascular, pulmonary, gi, dermatologic, psychiatric, neurologic (other than ms), endocrine, renal, and/or other major disease that would preclude participation in a clinical trial * history of gi surgery (except appendectomy that occurred more than 6 months prior to screening * history of clinically significant recurring or active gastrointestinal symptoms (eg, nausea, diarrhea, dyspepsia, constipation) within 3 months of screening * chronic use (7 days) of medical therapy to treat any gi symptoms within 1 month of screening has a clinically significant medical condition or observed abnormality at screening * history of a myocardial infarction, including a silent myocardial infarction or unstable angina * history of clinically significant drug or alcohol abuse within the past year prior to screening * clinically significant history of suicidal ideation or suicidal behavior in the last 12 months * subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration * prior use of dimethyl fumarate (dmf) note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: rrms multiple sclerosis ms alkermes alks 8700 dimethyl fumarate dmf tecfidera
intraoperative neuromonitoring recording with a novel scs paddle: phase ii

Conditions: Chronic Pain; Neuropathic Pain; Failed Back Surgery Syndrome; Complex Regional Pain Syndromes

Summary: the purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. the research electrode ("study electrode") is designed to answer basic physiological clinical research questions. it may inform future device therapy development, but the study electrode is not a product that will be marketed or sold. the investigators believe the protocol is a non-significant risk study answering basic physiological research questions, which may be performed under hospital irb approval.


Eligibility criteria:
inclusion criteria: * patients undergoing a spinal cord stimulation procedure for neuropathic pain. * have undergone a successful scs trial and are determined eligible for a permanent scs implant. * patients must be fluent in english as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams.- * subjects must be able to give informed consent. exclusion criteria: * patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain

Keywords: spinal cord stimulation chronic pain
effect of peng block application on inflammation and mortality in hip fractures

Conditions: Inflammatory Response; Anesthesia; Hip Fractures

Summary: in this study, the investigators the effect of peng block on siri (systemic inflammation response index) and 30-day mortality in geriatric patients(over 65 years old) undergoing hip surgery, and the effect on the length of hospital stay.

patients over the age of 65 who are scheduled for surgery due to hip fracture will be included in the study. according to the power analysis, a total of 60 patients will be included in the study. patients will be divided into 2 groups by randomization.multimodal analgesia will be applied to both groups. the first group will receive preoperative peng block and the other group will not receive an analgesic block and will receive paracetamol and tramadol hydrochloride analgesia. all patients received spinal anesthesia using 10 mg bupivacaine. preoperatively, il-6, crp, and hemogram tests will be performed on all patients and then these tests will be repeated 4, 24, and 48 hours after the surgical stimulus. at the end of the operation, total bleeding amounts, blood products and amounts given, and operation time will be recorded. postoperatively, nrs scores, initial analgesic requirements, hospital stays, and 30-day mortality will be monitored.

Eligibility criteria:
inclusion criteria: * asa 1-2-3 score * hip fracture surgery exclusion criteria: * refusal to participate in the study * asa score of 4 and above * obesity (bmi \>40) * failure of spinal block * switching to general anesthesia * patients undergoing revision surgery * patients with multitrauma * patients with old fractures (\>3 weeks) * patients receiving preoperative and intraoperative sedation * patients with active malignancy receiving rt, kt * patients with active infection, patients receiving antibiotic treatment * patients with contraindications for regional anesthesia techniques * patients receiving chronic treatment with steroids or immunosuppressants * patients using anti-inflammatory drugs

Keywords: peng block inflammation siri mortality hip fracture