Kornimate/medical-research-clean huggingface dataset:
e-health support program (pack health program) in supporting patient reported symptoms in newly diagnosed patients with breast cancer

Conditions: Breast Carcinoma

Summary: this trial studies how well an electronic (e)-health support program, called the pack health program, supports patient reported symptoms in newly diagnosed patients with breast cancer. pack health offers a symptom management program involving both interpersonal interaction, as well as e-modules for patients diagnosed with cancer to better manage pain, fatigue, depression, anxiety, and to navigate care more effectively through e-health coaching and tools. participating in the pack health program may support breast cancer patients' reported side effects and experience of care during chemotherapy treatment and may ultimately improve overall health.

primary objective: i. to examine the impact of an e-health support program on patient reported outcomes. secondary objectives: i. to evaluate the effect of e-health support program in comparison with standard of care support services, on the symptom experience of patients receiving chemotherapy in the ambulatory setting. ii. to evaluate the effect of e-health support program in comparison with standard of care support services, on the satisfaction of patients receiving chemotherapy in the ambulatory setting. iii. to evaluate the effect of e-health support program, in comparison with standard of care support services, on the frequency of emergency room visits and hospital admissions for patients receiving chemotherapy in the ambulatory setting. outline: patients are randomized to 1 of 2 groups. group i: patients participate in the pack health program which includes up to 60 scheduled touch points via phone, text, email and a mobile application, as well as weekly interaction with a health coach over 3 months. patients also have access to standard of care support services at md anderson including a telephone triage line 5 days a week between 8 a.m. and 5 p.m. group ii: patients receive standard of care support services with a telephone triage line available 5 days a week between 8 a.m. and 5 p.m.

Eligibility criteria:
inclusion criteria: * english speaking. * newly diagnosed women with a breast cancer diagnosis preparing to undergo chemotherapy for the first time. * all chemotherapy treatment to be completed at the study institution. * access to electronic resources, defined for the purposes of this study as a mobile phone, a landline phone, a computer, or another device with the capacity to receive calls, texts, or e-mails. exclusion criteria: * patients who have received previous chemotherapy treatment for cancer. * patients who are unable to verbalize (e.g. due to tracheostomy). * patients enrolled on protocol 2016-0300, as these patients will be receiving proactive triage calls from nurses that could skew their symptom reporting.
study of safety and efficacy of rvl-1201 in the treatment of blepharoptosis

Conditions: Blepharoptosis

Summary: phase 3 study to evaluate the safety and efficacy of treatment with rvl-1201 compared to placebo for treatment of blepharoptosis. eligible subjects will be randomized to one of 2 treatment arms.


Eligibility criteria:
inclusion criteria: 1. male or female 9 years of age or older 2. females must not be pregnant or planning to get pregnant and must use acceptable form of contraception 3. must be able to self-administer study medication 4. must be able to understand and sign an informed consent form. for minor subjects, the subject's parent or legal guardian must provide permission by signing an icf on behalf of the subject and the subject should provide assent. exclusion criteria: 1. congenital ptosis 2. horner syndrome 3. myasthenia gravis 4. mechanical ptosis 5. previous ptosis surgery 6. resting heart rate outside the normal range 7. hypertension with resting diastolic blood pressure 8. pregnancy or lactation
quality control of ce-certified phonak hearing aids - 2019_23

Conditions: Hearing Loss

Summary: phonak hearing devices pass through different development and study phases. at an early stage, feasibiltiy studies are conducted to investigate new algorithms, features and functions in an isolated manner. if the benefit is proven, their performance is then investigated regarding interpendency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. prior to product launch, the phonak hearing systems get reviewed by a final quality control in terms of clinical trials. this is a pre-validation study, investigating improved algorithms, features, functions and wearing comfort. this will be a clinical investigation which will be conducted mono centric at sonova ag headquarters based in stäfa (switzerland).

this study will prove the overall performance and system context of the functionality in the mobile application in combination with hearing devices under real life conditions with experienced hearing aid users. the enduser should be able to adjust their hearing aid settings by app. the app allows the user to change e.g. the loudness of the hearing aids and to create hearing scenarios by themselves. the users also shall be able to accept a conferecene call, which they will receive from the investigator via app. this will be a clinical investigation which will be conducted mono centric at sonova ag headquarters based in stäfa (switzerland).

Eligibility criteria:
inclusion criteria: * experienced hearing aid users (minimum age: 18 years, moderate to moderate/severe hearing loss) * modern subjects with an affinity to new technology * willingness and interest in testing apps * owning a compatible smartphone * healthy outer ear * willingness to wear behind the ear hearing aids * informed consent as documented by signature exclusion criteria: * the audiogramm is not in the fitting range of the intended hearing aid * limited mobility and not in the position to attend weekly appointments in stäfa (switzerland) * participant is not able to describe experiences and hearing impressions
characterization of low density lipoprotein and mechanism of the pro aggregant effect through oxidant stress and lipid exchange

Conditions: Diabetes; Metabolic Syndrome

Summary: case control design: lipidomic study in 12 type 2 diabetics with metabolic syndrome, 12 metabolic syndrome without diabetes, 12 subjects with type 1 diabetes and 12 controls


Eligibility criteria:
inclusion criteria: * statin and fibrate wash out for one week * hba1c\>7% and \<12% (arms 1 and 3) * hba1c\<6% (arms 2 and 4) * metabolic sd according ncep iii (3 out 4 criteria) (arms 1 and 2) exclusion criteria: * secondary cv prevention

Keywords: platelet function diabetes metabolic syndrome
psychometric testing of the norwegian version of the comfort behavioral scale

Conditions: Postoperative Pain

Summary: the purpose of this study is to establish reliability and validity of the norwegian version of the comfort behavioral scale.

structured pain assessment is the foundation for the management of pain. several different pain measurement tools exists, among them the comfort behavioral scale (van dijk, 2005), developed from the original comfort scale (ambuel, 1992). the psychometric properties of the comfort scale have been tested in several studies, but so far no norwegian version of the scale has been developed and tested. neither has the scale been tested in spontaneously breathing children undergoing minor surgery. the aim of this study is to establish incipient psychometric properties of the norwegian version of the scale among children aged 0-3 years admitted for elective minor surgery.

Eligibility criteria:
inclusion criteria: * younger than 3 years old at the time of surgery * day care patients admitted for minor elective surgery exclusion criteria: * pre-entry use of sedation and/or analgesics * neurological or other diseases or drugs (neuromuscular blockers) thet significantly influence motor activity, facial expression, cognition, or emotional state, ex. cerebral palsy, myopathy, severe mental retardation, severe hypotonia, neuromuscular disease

Keywords: comfort behavioral scale pain assessment scale child validity reliability
integrated smart speaker promoting positive parenting among caregivers of youth with challenging behaviors

Conditions: Oppositional Defiant Disorder; Conduct Disorder

Summary: this project will develop and evaluate the feasibility of an integrated smart speaker and mobile/web-based application, "familynet" (fn) to assist parents in implementing empirically supported behavioral parenting strategies to promote positive behavior change in their children. the familynet system will help parents to create a positively framed, individualized behavioral plan for their child(ren), and then provide prompts, reminders, and tracking tools to help them effectively implement that plan. once developed, familynet will be field tested for usability and usefulness with a group of parents who have children ages 10-17 years exhibiting challenging behaviors. establishing feasibility of this innovative parenting tool will have important implications for harnessing smart speaker and mobile/web technologies to provide parents in-situ support with parenting challenges; parents' effective implementation of empirically supported parenting strategies is likely to increase children's prosocial behaviors and reduce problematic behaviors, thus reducing their risk for long-term behavioral problems.

this project will develop and establish feasibility of an integrated smart speaker and mobile/web application, familynet, designed to help parents utilize best practices in behavioral parent training to create and implement personalized behavior plans for their children. the familynet system will integrate mobile app, smart speaker technology, and website technologies to assist families in creating their behavior plan, and then will track compliance, timelines, incentives, and other details to assist parents in following through and maintaining the behavior change program that they have created. after development, the intervention program will be pilot-tested with up to 35 families of youth ages 10-17 with challenging behaviors. primary parents will complete measures of parenting practices and child behavior prior to using the familynet system, and again after having access to the program for 4 weeks. during the intervention period, user information will be tracked. post-intervention measures will also include primary parents' perceptions of usability and acceptability of and satisfaction with the familynet system. children will also complete satisfaction questionnaires at the post- intervention assessment. data will be analyzed to determine the degree to which families are able to utilize the familynet interface and report finding it helpful.

Eligibility criteria:
inclusion criteria: 1. primary parent/caregiver who has a child ages 10- to 17-years-old who lives with them at least half the time 2. has a smartphone and access to email 3. speaks english exclusion criteria: a. the target-age child has a developmental disability severe enough that the child is unable to speak and/or follow simple directions.
amyloid imaging and safety study of acc-001 in subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: a phase ii clinical research study to evaluate the efficacy and safety of two different dose levels of an injectable investigational treatment (acc-001) in subjects with mild-to-moderate alzheimer's disease. acc-001 (vanutide cridificar) is a beta amyloid fragment attached to a carrier protein. it is intended to help induce an antibody response against beta amyloid and is administered as an intramuscular injection.


Eligibility criteria:
inclusion criteria: * diagnosis of probable ad * age from 50 to 89 * mini-mental status exam score of 18-26 inclusive * brain magnetic resonance imaging (mri) scan consistent with the diagnosis of ad * stable doses of medications (cholinesterase inhibitors and memantine allowed) * caregiver able to attend all clinic visits with patient * amyloid burden on screening pet scan consistent with diagnosis of ad exclusion criteria: * significant neurological disease other than ad * major psychiatric disorder * significant systemic illness * history of stroke, seizure or autoimmune disease * history of myocardial infarction within the last 2 years * smoking greater than 20 cigarettes per day * anticonvulsants, anti-parkinson's, anticoagulant, or narcotic medications (anticonvulsants used for non-seizure reasons are allowed) * prior treatment experimental immunotherapeutics or vaccines for ad * women of childbearing potential * presence of pacemakers, csf shunts, or foreign metal objects in the eyes, skin or body

Keywords: mild to moderate alzheimer's disease immunization amyloid imaging injection vaccine
evaluation of gastrointestinal symptoms following chilean native beans consumption

Conditions: Gastrointestinal Disease; Flatulence; Gastrointestinal Tolerance; Distension; Bowel; Bloating

Summary: the oligosaccharide content (raffinose, stachyose, and verbascose) in legumes would be responsible for gastrointestinal symptoms (bloating, pain, meteorism), associated with its consumption. we would evaluate consumption of 3 varieties of chilean native beans, and evaluate gastrointestinal symptoms produced along with expired h2 test, to correlate this with the amount of oligosaccharide content.

different varieties of legumes have different oligosaccharide contents, in a study in poland, it is described that the content of stachyose between 3 varieties can be as different as 493 mg, 865 mg or 1200 mg per 100 grams of dried beans (slupski 2014). along with this it has been described that the different culinary preparations of the legumes decrease the anti-nutritional factors, so, when soaking for 6 hours it shows 16.5% of undigested sugars reaching the small intestine, but it is possible to digest 95% in the colon (noah 1998). soaking for 16 hours, decreases 85% phytate content, 84% tannin content, 25% raffinose content, 25% stachyose and 41% verbascose (hurtado 2001). the oligosaccharide content (raffinose, stachyose, and verbascose) would be responsible for gastrointestinal symptoms (bloating, pain, meteorism), associated with legume consumption. this is because these sugars are galactooligosaccharides, which are not digested in the human intestine because it does not have an alpha-galactosidase enzyme (hessels 2003). in our study, 25 varieties of chilean bean are being evaluated, with nutritional analysis, resulting in a variation between 18 and 25 grams of protein per 100 grams dry (unpublished data), the oligosaccharide content still pending will be evaluated for select the 3 varieties that contain more proteins and less oligosaccharides. these varieties with better nutritional "profile" will be selected, to be evaluated clinically.

Eligibility criteria:
inclusion criteria: * beans consumption on a regular basis (at least once a week) * without obvious intolerance to beans intake exclusion criteria: * clinical history of recurrent gastrointestinal discomfort * diagnosis of any gastrointestinal disease (gastroesophageal reflux, gastritis, irritable bowel syndrome, chronic diarrheal syndrome, etc.). * meeting rome iv criteria for diagnosis of irritable bowel syndrome. * use of medications that affect gastrointestinal motility (omeprazole, metoclopramide, domperidone, loperamide, etc.) or antibiotics in the last month.

Keywords: phaseolus symptoms expired hydrogen bloating bean tolerance beans
tc99m sestamibi molecular breast imaging

Conditions: Breast Cancer

Summary: this clinical trial studies technetium tc-99m sestamibi molecular breast imaging in predicting tumor response in patients with locoregional breast cancer that has spread from where it began in the breast to surrounding normal tissue who are receiving neoadjuvant chemotherapy. comparing results of diagnostic procedures, such as technetium tc-99m sestamibi molecular breast imaging, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

primary objective: i. to evaluate the ability of technetium tc-99m sestamibi (tc 99m sestamibi) molecular breast imaging (mbi) to predict early response to neoadjuvant chemotherapy (nac) and to assess residual disease at the completion of nac in patients with locoregional invasive breast cancer. secondary objectives: i. to evaluate and qualitatively characterize tc 99m sestamibi uptake by tumor on mbi at the baseline, after 2 cycles of nac and at the completion of nac. ii. to compare assessment of tumor response to nac by mbi with digital mammography (dm), and breast ultrasound (us) exams. iii. to compare tumor size and distribution observed from mbi at the completion of nac with extent of residual disease at surgery by pathological evaluation. iv. to develop image acquisition and processing algorithm that quantifies the tc 99m tumor uptake. exploratory objective: i. to determine effect of molecular subtype of cancer (her2+, er/pr/her2- and er+/her2-) on diagnostic performance of mbi in predicting treatment response. outline: patients undergo technetium tc-99m sestamibi molecular breast imaging over 45 minutes at baseline (before start of nac), after 2 courses of nac (6-12 weeks, depending on the regimen), and the completion of nac but before surgery. patients also undergo breast ultrasound and mammographic imaging as standard of care at the same time points.

Eligibility criteria:
inclusion criteria: 1. female of 18 years and older of any race 2. has biopsy-proven invasive breast cancer (bi-rads 6) and scheduled for neoadjuvant chemotherapy (nac). 3. newly diagnosed biopsy proven locoregional invasive breast cancer at md anderson cancer center, or referred to md anderson for treatment after initial radiologic (mammographic, sonographic, etc.) exams at an outside institution in whom nac is planned. 4. patients with stage t1 or greater (t1-t4), nodal involvement (n0 - n3), without metastasis (m0) invasive breast cancer, including patients with inflammatory breast cancer. 5. patients who agree to sign an informed consent to undergo mbi exclusion criteria: 1. is under 18 years of age 2. is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother 3. has lesions involving chest wall 4. has known allergy to tc99m sestamibi

Keywords: breast cancer molecular breast imaging mbi tc99m sestamibi neoadjuvant chemotherapy nac
the effect of mindfulness-based cognitive therapy program applied to nursing students

Conditions: Mindfulness; Depression, Anxiety; Stress; Nursing Students

Summary: among the stress factors of nursing students are traumatic experiences such as death and encountering a dying patient from the first moments of their education years, fear of making mistakes in the clinic, patient care, not getting enough support from the instructor or clinic staff, and communication problems. exposure to long-term and uncontrollable stress negatively affects students' professional identity development and health. students who cannot cope with their stress feel stress at a higher level and as a result they may experience anxiety and depression.it is important for nurse candidates to graduate by being supported in all aspects, both in terms of individual and professional development. for this reason, nursing educators should use effective and innovative interventions to help students recognize the stress they experience and help them reduce stress. mindfulness-based cognitive therapy program (mbct) is one of these programs. although studies with mbct are found in the literature, our country in the literature, no randomized controlled studies were found with nursing students. in line with this information, it was thought that mindfulness-based studies were needed. this study was planned to determine the effect of mbct program on depression, anxiety, stress and cognitive flexibility of nursing students.

inclusion criteria for research * to be nursing students * to have a score of 4 or more (general health questionnaire) * internet access to participate in online sessions * individuals who voluntarily agree to participate in the research will be included. exclusion criteria from the research * those who are in the acute depression period * risk of suicidal * having participated in mbsr-mbct programs before application protocol principles * to consider students individuality, to provide correct information/education, * guiding to increase motivation, * giving feedback and supporting individuals, * to provide accessibility for individuals' concerns and questions,

Eligibility criteria:
inclusion criteria: * being a student of düzce university, faculty of health sciences, department of nursing * individuals who voluntarily agree to participate in the research exclusion criteria: * those in acute depression
protocol for the treatment of metastatic ewing sarcoma

Conditions: Ewing's Sarcoma (ES)

Summary: study for the treatment of metastatic ewing sarcoma with high doses chemotherapy, radiotherapy and maintenance therapy.

study for the treatment of ewing metastatic sarcoma with and induction phase with vincristine (vin), adriamycin (adm), ciclofosfamide(cyc), ifosfamide(ifo), etoposide(eto) and radiotherapy (rt)followed by a consolidation phase with busulfan and melfalan (bumel) and peripheral blood stem cells transplantation (pbsct) and a subsequent maintenance phase with ciclofosfamide and celecoxib for high risk (hr) patients. very high risk (vhr) patients will receive a prior frontline therapy with temozolomide and irinotecan (temiri), while patient with lung metastasis only will undergo to total lung irradiation after pbsct

Eligibility criteria:
inclusion criteria: * histologically proven ewing's sarcoma * age ≤ 40 years * no previous treatment * multiple skeletal metastasis or bone marrow infiltration , with/without lung/pleural metastasis * signed informed consent exclusion criteria: * localized ewing's sarcoma * any contraindications to the study treatment * female patients who not accept to use an effective birth control method. * pregnant or breast-feeding patients