Kornimate/medical-research-clean huggingface dataset:
evaluation of needle core biopsy of axillary sentinel lymph node in breast cancer

Conditions: Breast Cancer

Summary: the purpose of the study is to determine if it is possible to identify and perform a needle biopsy of the sentinel lymph node. the investigators hope to identify breast cancer cells in the lymph nodes under the arm without making an operation necessary. the rationale for this study is that for patients without enlarged lymph nodes under the arm, sentinel lymph node biopsy is the standard way of determining if breast cancer has spread to the lymph nodes under the arm. while the complications from a sentinel lymph node dissection are less than that of a complete axillary lymph node dissection, sentinel lymph node dissection still carries small risks of arm swelling, decreased movement, fluid collections, nerve injury, and pain. furthermore, the majority of sentinel lymph nodes do not contain cancer. the investigators hope to develop a method to find cancer in the axillary lymph nodes and avoid the complications of an operation.

in patients already scheduled to undergo sentinel lymph node dissection in the operating room, the investigators will first perform an axillary ultrasound guided core needle biopsy percutaneously. patients will have already undergone prior injection of radioisotope and blue dye and as a standard procedure or the sentinel lymph node dissection. after induction of anesthesia, the investigators will identify the location of the sentinel node with a gamma probe to identify the "pre-incision hot spot." axillary ultrasound will then be used to identify the location of the lymph node and a percutaneous core needle biopsy of the targeted lymph node will be performed. the core biopsy specimen will be evaluated for the presence of blue staining and radioisotope uptake intraoperatively. the core biopsy specimen will then will be sent for pathologic analysis. the percutaneous biopsy should take about 10 minutes of additional operating room time. the operation will then proceed as planned with dissection and removal of the remaining sentinel node(s). core samples and sentinel lymph nodes will be evaluated in a similar fashion per existing sentinel node protocol.

Eligibility criteria:
inclusion criteria: * breast cancer patients eligible for sentinel node dissection * invasive ductal or invasive lobular carcinoma * ductal carcinoma in situ undergoing total mastectomy * clinically node-negative * 18-100 years exclusion criteria: * inflammatory breast cancer * pregnant or lactating * preoperative chemotherapy * prior axillary ultrasound guided core needle biopsy

Keywords: sentinel lymph node ultrasound guided needle core biopsy
feasibility of a molecular characterisation approach to treatment

Conditions: Advanced Gastrointestinal Cancers

Summary: this study will assess the feasibility of sequencing locally advanced/metastatic gastrointestinal cancers in real-time to enable future treatment stratification by molecular characteristics. targeted next generation sequencing of a panel of genes will be performed on tumour specimens and results will be discussed at a sequencing tumour board to establish if a patient is potentially suitable for a targeted therapy.


Eligibility criteria:
inclusion criteria: 1. locally advanced or metastatic gastrointestinal cancer (including oesophageal, oesophagogastric junction, gastric, pancreatic, biliary and colorectal cancers). 2. histological or cytological confirmation of diagnosis of malignancy. 3. patients must either: 1. have received at least one line of treatment for locally advanced/metastatic disease or 2. be about to start/currently undergoing their first line of treatment for locally advanced/metastatic disease 4. 18 years of age and over . 5. performance status less than or equal to 2. 6. able to provide fully informed consent. 7. patients must either: 1. have an available tumour specimen (ffpe or fresh frozen) from either the primary tumour or a metastasis. metastatic samples may be from any site with the exception of bone. or 2. have a site of disease which is amendable to biopsy exclusion criteria: * there are no specific exclusion criteria for this study.

Keywords: molecular profiling genetic sequencing personalised medicine gastrointestinal cancer
hearthab, can a patient-tailored application support coronary artery disease patients during rehabilitation?

Conditions: Coronary Artery Disease

Summary: the hearthab study is a pilot trial in which coronary artery disease patients (n = 15-30) are given the hearthab application. the hearthab application is a smarthphone based mobile application that serves as a secondary prevention tool, to support cardiac patients after their phase ii cardiac rehabilitation program. during study period (4-6 weeks), participating patients will be asked to use the application. hearthab includes a module devoted to therapy compliance, one to exercise training prescription and one to risk factor control. hearthab aims to motivate the patient to improve his/her self-management skills and hence decrease cardiovascular morbidity (and mortality). motivational aspects and usability data will be collected during study period by means of app logs and/or questionnaires/interviews.


Eligibility criteria:
inclusion criteria: * patients with coronary artery disease for which they received a percutaneous coronary intervention, coronary artery bypass grafting or drugs only. * patients that have completed the standard cardiac rehabilitation program * patients who have access to a computer and a wifi internet connection * patients that are able to go to the rehabilitation centre rego of jessa hospital * patients who signed the informed consent document exclusion criteria: * patients with a history of vf, sustained vt and/or supraventricular tachycardia during the last 6 months before enrollment. * patients who due to cognitive, neurological and/or musculoskeletal constraints are unable to ride a bicycle. * patients with a pacemaker or defibrillator. * non-dutch speaking patients * patients who simultaneously participate in another study
behavioral interventions to prevent or delay dementia

Conditions: Mild Cognitive Impairment; Memory Disorders; Mild Dementia; Impaired Cognition; Mild Cognitive Disorder; Amnestic Disorder; Dementia and Amnestic Conditions; Poor Short-term Memory; Memory Impairment

Summary: this study will compare the effectiveness of different combinations of 5 types of behavioral interventions across patient-centered outcomes. it will also evaluate which outcomes (e.g. quality of life, cognition, function, mood) matter most to people at risk for dementia and their care partners. the results of this study have the potential to direct patients, families, and health care providers as to which combinations of behavioral interventions provide the greatest potential impact on which dementia prevention outcomes. greater use of behavioral strategies that are targeted to the outcomes of most important to the patient will likely improve patient compliance and treatment adherence. this, in turn, can lessen the need for medication, health care, and long term care utilization.

traditional randomized controlled trials (rcts) can be thought of as 'additive' trials where randomization leads to the addition of treatments beyond placebo. participants are confronted with the probability of receiving placebo (no treatment). this leads many potential participants to not consent or to withdraw if they believe they are receiving no treatment. in contrast, the proposed trial will be 'subtractive'. this innovative approach to randomization will involve suppression of just 1 of the 5 treatment components. thus, all participants will receive at least 80% of the menu of interventions offered in this trial.

Eligibility criteria:
inclusion criteria: a candidate for the habit program with a diagnosis of amnestic mci (confirmed at eligibility visit by a clinical dementia rating (cdr) scale of 0.5). a cognitively normal care partner who has at least twice-weekly contact with the participant. either not taking or stable on memory medicine(s) (e.g. donepezil) for at least 3 months. fluent in english. (expanding the program to communities of spanish- speakers will be a high priority in subsequent dissemination work). exclusion criteria: inclusion in another clinical trial that would exclude participation. subject will be considered for participation at the end of such a trial or as appropriate. medically unable to participate in all arms by virtue of visual or auditory impairments or non-ambulatory status.

Keywords: behavioral intervention mild cognitive impairment habit cognitive rehabilitation multi-component intervention
biomarkers of bone resorption in metastatic prostate cancer

Conditions: Metastatic Prostate Cancer

Summary: biomarkers of bone resorption will be measured in the blood of patients with bone metastases from prostate cancer during the course of their illness. changes in these biomarkers will be correlated with the patient's treatment with antiandrogen therapy and bisphosphonates and the response and/or progression of their cancer. it is hoped that serial measurement of these biomarkers may allow therapeutic monitoring in the future with successful individualisation of bisphosphonate therapy for metastatic prostate cancer.


Eligibility criteria:
inclusion criteria: * prostate cancer with bone metastases * hormone sensitive exclusion criteria: * inadequate renal function * ongoing dental problems * previous bisphosphonate therapy
icbt for depression - standard versus condensed treatment material

Conditions: Major Depression

Summary: internet-based cognitive behavior therapy (icbt) has been shown effective for depression in several studies, however the investigators know very little about how the written treatment material should be designed to be effective and at the same time acceptable to the patients. the investigators are not aware of any research that has investigated if slow readers, or persons with difficulty concentrating, can use the standard material or if they would benefit more from using an adapted version. in this study the investigators will assess reading speed and the ability to concentrate in all patients and then randomise them to an internet-based treatment for depression using either a standard material or a condensed one. the condensed material consists of 30000 words and will be available as text files and on audio files. the standard material consists of 60000 words and is only available as text files. both groups will have the possibility of e-mail contact with a personal therapist during the treatment. patients will be recruited within örebro county by referrals and self-referrals. the goal is to recruit between 200 and 300 patients during 2 years. the treatment time will be 10 weeks and all patients will be assessed for depression at an interview with a psychologist. there will also be interviews after treatment and one year after treatment. the most important outcome will be depressive symptoms.


Eligibility criteria:
inclusion criteria: * fullfill criteria for diagnosis of major depression * being able to read and write swedish * have access to the internet * being a resident in örebro county exclusion criteria: * severe depressive symptoms (\>34 on the madrs-s) * high risk for suicide * attending cognitive behavior therapy * psychosis * bipolar disorder * addiction to alcohol or illegal drugs * a somatic or psychiatric condition that is a contraindication for icbt or in some way debars icbt, or have to be treated before depression

Keywords: depression internet cognitive behavior therapy
evaluation of the relationship of vitamin d and vitamin d binding protein with disease severity in pediatric sars-cov2

Conditions: SARS CoV-2 Infection

Summary: there were many studies in the literature discussing the effects of vitamin d deficiency and the role of vitamin d supplementation in sars-cov-2 patients. combined with the possible impact of vitamin d on the pathogenesis of sars-cov-2 infection, it is concluded that vdbp-regulated bioavailable and free vitamin d concentrations modulate the human immune system response to viral infections. because of the gap in the literature, it was emphasized that studies should focus on vitamin d binding protein (vdbp) and gene polymorphism. in this study, it was aimed to investigate the relationship between sars-cov-2 infection severity and free and bioavailable vitamin d levels.

it was aimed to investigate the relationship between sars-cov-2 infection severity and free and bioavailable vitamin d levels. this study was planned as a case-control study with patients hospitalized in the haseki training and research hospital pediatric infection service. a total of 82 children, including at least 20 patients in each group were included in the study. the study group was divided into three groups according to covid-19 who clinical progression scale: unaffected (group 1), mild (group 2) and moderate (group 3). in order to investigate the relationship between disease severity and free and bioavailable vitamin d; 25oh vitamin d (μg/l), albumin (g/l) and vdbp levels (elisa) were used. vitamin d metabolites were calculated by using bikle and vermeulen methods (free vitamin d bikle, free vitamin dvermeulen, bioavailable vitamin d). and these three vitamin d parameter levels were compared between groups.

Eligibility criteria:
inclusion criteria: * age between 1-18 years old, * positive for sars-cov-2 pcr or positive for igm in the sars-cov-2 antibody test (card test or elisa), * do not have a chronic disease (cystic fibrosis, etc.), * volunteer to participate in the study. exclusion criteria: * being \< 1 year of age

Keywords: sars cov-2 vitamin d binding protein free vitamin d bioavailable vitamin d children
the prognostic value of the degree of pathological response of induction chemotherapy for npc

Conditions: Nasopharyngeal Carcinoma; Pathologic Complete Response; Tumor Microenvironment

Summary: this study aims to explore the prognostic value of pathological remission after one cycle of induction chemotherapy in locally advanced nasopharyngeal carcinoma, and the change of immune micro-environment after one cycle induction chemotherapy, including the density of immune cells infiltration and tertiary lymphoid structures.


Eligibility criteria:
inclusion criteria: 1. ability to sign informed consent 2. age \> 18 years at time of study entry 3. eastern cooperative oncology group (ecog) performance status of 0 or 1 (amend based on specific study) 4. histological confirmation of npc (regardless if eber positive or negative) 5. locally advanced npc, uicc stage iii-iva 6. subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. exclusion criteria: 1. concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study 2. distant metastases 3. prior systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, radiotherapy, biologic therapy, tumour embolization, monoclonal antibodies) of the locally advanced npc. 4. history of another primary malignancy 5. female patients who are pregnant 6. known allergy or hypersensitivity to any drugs 7. judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
creation of a probabilistic atlas of normal cerebral uptake of 18f-fdg in pet/mri.

Conditions: Brain Diseases

Summary: with 18f-fdg pet, we have few atlases of normality allowing the realization of objective quantitative analyses. an atlas of normality is a probabilistic atlas of normal fdg uptake from a representative set of brain pet images of healthy subjects. this type of atlas is essential for intra- and inter-individual comparisons. accurate quantitative analysis of brain 18f-fdg pet images acquired on a hybrid pet system has been shown to require an institutional normal database for statistical analyzes (akdemir et al., jnm 2017 and della rosa et al neuroinformatics, 2014).

this is a prospective, monocentric, non-randomized study, with no direct individual benefit since it involved healthy volunteers.

Eligibility criteria:
inclusion criteria: * male or female aged 20 to 50 * absence of any history or cardiovascular, neurological or psychiatric deficit * signed the informed consent exclusion criteria: * contraindication to the realization of an mri or pet and to the injection of 18f-fdg * people using a pacemaker or insulin pump * people wearing a metal prosthesis or an intracerebral clip * people with intraocular metal splinters * people with a pathology considered incompatible for the production of the atlas according to the investigator * pregnant women and breastfeeding women * subject in period of exclusion.

Keywords: fdg pet pet-mri atlas brain
effects of oral nutrition supplement in thai malnourished patients

Conditions: Malnourished; Hospitalized

Summary: a retrospective study based on thai data from nutrition day study (nd). comparing clinical outcome between malnourished patients who were prescribed oral nutrition supplement along with hospital diet and those without oral nutrition supplement.

prevalence of malnutrition in hospitalized patients varies from 30-70% depend on category of patients recruited. adverse effects of malnutrition include increase of infection complication, increase hospital length of stay, and increase mortality. prescription of oral nutrition supplement (ons) have been proved to provide patients more calorie and protein intake and can improve patients' outcome. despite the proved benefits of oral nutrition supplement(ons), prescription of it in thai hospitalized patients are far less than it should. the main reason of this under-practice is the limitation of health policies which considered ons as an optional from main meals. additional cost for ons has to be paid by patients themselves, therefore the patients who have no willing to pay usually refuse to receive ons. unawareness of physician regarding its benefits is also a problem. in order to convince thai authorities to allow for reimbursement of ons and encourage prescription of ons among physicians, an evidence based benefits of ons in large thai population is needed. the nd study was a single-day, population-based, standardized, multinational, cross-sectional audit and was performed worldwide, includes thailand, in hospitals, nursing homes and intensive care units performing since 2006 to present. every year, registered hospitals survey their patients regarding nutritional status, nutritional support. a follow-up for clinical outcome are perform at 30 days after the first survey, include mortality, readmission. this study will based on data of thai patients collected from nd study during 2006-2016.

Eligibility criteria:
inclusion criteria: * age 18 years old and above * identified as malnourished or at risk exclusion criteria: * terminally ill patients * receiving concomitant enteral tube feeding and/or supplemental parenteral nutrition

Keywords: oral nutrition supplement malnutrition mortality
evaluation of the efficacy and safety of adjunctive zonisamide vs replacement with zonisamide of the last added antiepileptic drug

Conditions: Partial Seizures

Summary: an open-label, randomized, multi-centre, superiority study to assess that, in patients who respond to zonisamide added as third drug after failure of a two-drug combination therapy, the triple therapy is superior to the conversion to a double therapy including zonisamide.


Eligibility criteria:
patients with localization-related epilepsy, who have added a second drug to the monotherapy, haven't obtained an adequate reduction of seizure frequency with this combination and have responded to zonisamide added as third drug for at least three months. inclusion criteria: * age ≥ 18 years; * patients with non progressive localization-related epilepsy; * patients who are able and willing to give written informed consent; * current treatment with three antiepileptic drugs. the last antiepileptic drug introduced must be zonisamide; * 50% or greater seizure reduction\* as assessed after an at least three-month maintenance period with zonisamide. * = seizure frequency before starting zonisamide must be documented checking case histories. exclusion criteria: * patients contraindicated for zonisamide use (see smpc); * patients with renal or hepatic impairment; * pregnant or lactating women; * women of childbearing age who are not willing to use any contraceptive method with established efficacy. * patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation; * patients with a history (within the last 12 months) of alcohol or drug abuse or dependency; * patients who have been on an investigational drug or device within 30 days prior to the initiation of the present study; * patients with a documented computed axial tomography (cat) scan or magnetic resonance imaging (mri) scan confirming the presence of a progressive neurological lesion within 12 months of the screening visit.
safety, tolerability, patient satisfaction and cost of 16.5% subcutaneous immunoglobulin (cutaquig®) treatment

Conditions: Primary Immunodeficiency Disease; Secondary Immunodeficiency

Summary: patients with primary or secondary immunodeficiency disease who have developed adverse reactions to products available on the market such as cuvitru® (shire), hizentra® (csl behring) or 10% gammunex® (grifols), may benefit from utilizing 16.5% cutaquig® (octapharma).

this is a prospective interventional study before and after clinically driven change in treatment formulation. polyvalent immunoglobulin treatment is used in patients with primary or secondary antibody deficiency diseases to prevent and lower the risk of infection. there are multiple products available in the market. most products are administered via intravenous route such as privigen® (csl behring), gammunex® (grifols), and panzyga® (octapharma). up until recently, there have been only two products that are licensed for subcutaneous administration - 20% hizentra® (csl behring) and 10% gammunex® (grifols). in our clinical experience, approximately 10% of patients treated with 20% hizentra® developed adverse reactions. some are mild and tolerable. some are moderate to severe and required alteration of treatment plan: for example, changing the product from 20% hizentra® to 10% gammunex®. however, this results in a 100% increase in the injection volume due to the lesser concentration of the product, but a decrease in viscosity - both of which might alter overall tolerance. likewise, any new treatment may bring new adverse events such as rash. in 2018, there will be two additional subcutaneous immunoglobulin products available in canada - 16.5% cutaquig® (octapharma) and 20% cuvitru® (shire). even though both new products are licensed and proven to be efficacious regarding preventing significant infection (1,2), the relative safety, tolerability, patient satisfaction, treatment-associated cost has not been studied in patients using the 16.5% cutaquig®. the study product will be provided through the canadian blood service (cbs) on a special request basis which is a standard procedure for any patients who are intolerable to inventory products.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and older * patients with primary or secondary immunodeficiency disease who are currently on subcutaneous immunoglobulin treatment but have developed adverse events and are willing to change the treatment product. exclusion criteria: * pregnant women