Kornimate/medical-research-clean huggingface dataset:
cardiac resynchronization therapy in congenital heart diseases with systemic right ventricle

Conditions: Congenital Heart Disease

Summary: this study aims to analyze outcomes of patients with systemic right ventricle (srv) implanted with cardiac resynchronization therapy (crt) systems and to compare the impact of crt in srv patients with other congenital heart diseases (chd).

heart failure is henceforth the main cause of death in adult patients with congenital heart disease (chd). the number of affected patients is expected to continue to grow exponentially due to the important increase and aging of this population. in symptomatic patients despite optimal pharmacological therapy, cardiac resynchronization therapy (crt) offers a well-recognized therapeutic option in dilated and ischemic cardiomyopathies with severely impaired left ventricle ejection fraction and complete left bundle branch block. in patients with chd, the level of evidence is much more limited. underlying phenotypes are heterogeneous, including systemic right ventricles (srvs), isolated sub-pulmonary right ventricle dysfunctions, single ventricles, and most of patients have a right bundle branch block. all these specificities question the extrapolation of data reported in patients with acquired cardiomyopathies. despite the lack of evidence, crt systems have been progressively used in chd patients, also because alternative options are poor, mainly represented by cardiac transplantation, but grafts are rare and congenital patients frequently have contraindications. a positive impact of crt in chd has first been suggested in small series where hemodynamic invasive parameters (e.g. dp/dt max) were improved and qrs narrowed by multisite pacing. a few subsequent studies then reported an improvement of ventricular functions and patient-reported functional subjective parameters (mainly nyha classification). however, the number of patients included in most studies was limited and heterogeneous forms of chd were often pooled when interpreting results. the studies evaluating crt specifically in patients with srv are very rare and demonstrated conflicting results. the largest study to date assessing specifically crt in patients with srv included 20 patients with congenitally corrected transposition of the great arteries (cc-tga) and demonstrated an acute improvement in two-thirds of patients. although patients with srv represent one of the main groups of chd patients currently implanted with crt, the paucity of specific data in this population has been highlighted as a major evidence gap and as a high-impact research question by the american heart association/american college of cardiology guidelines committee.

Eligibility criteria:
inclusion criteria: * all patients with congenital heart disease and crt device exclusion criteria: * patient's refusal

Keywords: cardiac resynchronization therapy congenital heart disease systemic right ventricle outcomes
staphylococcus aureus bacteraemia (sab)-support-study

Conditions: Staphylococcus Aureus Bacteremia

Summary: the main objective of this study is to investigate whether checklist-based close telephone consultation and process surveillance for s. aureus bacteraemia (sab) can improve adherence to our in-house sab-guidelines (prospective quality- improvement group). in addition, the effects of telephone consultation on the clinical outcome of patients will be examined.


Eligibility criteria:
inclusion criteria: * ≥ 18 years * inpatient treatment at the university medicine greifswald university hospital * first diagnosis of sab in hospital exclusion criteria: * sab already known before admission * palliative management within 48 hrs after sab diagnosis * death within 48 hrs after sab diagnosis * hospital discharge within 48hrs after sab diagnosis

Keywords: staphylococcus aureus bacteremia
microrna profiles identification in adeno carcinoma prostate cancer

Conditions: Prostate Carcinosarcoma

Summary: in our study, the investigators want to find correlation between circulating mirnas associated with prostate cancer metastases to bones and to lymph nodes separately with results of 68ga-psma ligand pet (positron emission computed) imaging.


Eligibility criteria:
inclusion criteria: * proven adeno-carcinoma * underwent prostatectomy and still present high psa levels * refered to psma exam. exclusion criteria: * below 18 years old * hiv/hbv (hepatitis b virus)/hcv (hepatitis c virus) positive * additional malignancy during the past five years.

Keywords: microrna prostate carcinoma pet-mr
single dose gonadotropin-releasing hormone (gnrh) agonist administration in the luteal phase of gnrh antagonist stimulated icsi-et cycles

Conditions: Infertility

Summary: gnrh agonist administration in the luteal phase was reported to beneficially affect clinical outcome of icsi-et cycles. this randomized controlled trial evaluates the effect of a single dose gnrh agonist administered in the luteal phase on the outcome of icsi - et cycles stimulated with the fixed gnrh antagonist protocol. women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed gnrh antagonist protocol were included. in addition to routine luteal phase support with progesterone women were randomized to receive a single dose of gnrh agonist or placebo on the sixth day after icsi.ongoing pregnancy rate was the primary outcome measure.


Eligibility criteria:
inclusion criteria: * women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed gnrh antagonist protocol, oocyte pick-up and icsi. * embryo transfer performed on day 3 exclusion criteria: * participation in another trial that was being conducted in our unit at the same time. * preimplantation genetic screening cycles. * day 5 embryo transfers.

Keywords: gnrh agonist gnrh antagonist ivf icsi assisted reproduction luteal phase
developing an artificial intelligence system to detect cognitive impairment

Conditions: Alzheimer Disease; Healthy Aging; Mild Cognitive Impairment

Summary: alzheimer's disease dementia (ad) is a debilitating and prevalent neurodegenerative disease in older adults globally. cognitive impairment, a hallmark of ad, is assessed through verbal tests that require high specialization, and while accepted as screening tools for ad, general practitioners seldom use them. ad can be diagnosed with expensive, invasive neuroimaging and blood tests, but these are usually conducted when cognitive functioning is already severely impaired. thus, finding a novel, non-invasive tool to detect and differentiate mild cognitive impairment (mci) and ad is a prime public health interest. self-figure drawings (a projective tool in which individuals are asked to draw a picture of themselves), are easy to administer and have been shown to differentiate between healthy and cognitively impaired individuals, including ad. convolutional neural network (cnn) (a type of deep neural network, applied to analyze visual imagery) has advanced to assess health conditions using art products. therefore, the proposed study suggests utilizing cnn-based methods to develop and test an application tailored to differentiate between drawings of individuals with mci, ad, and healthy controls (hc) using 4,000 self-figure drawings. this


Eligibility criteria:
inclusion criteria: * adults aged 60 and above with subtle signs of risk of future cognitive decline, residing in the community or in nursing homes with a minimum of 10 years of education. exclusion criteria: * current or past psychiatric illness, the presence of congenital/organic cognitive condition, severe visual or motor impairment, and terminal illness (to avoid the effect of comorbidities).
dead space closure with quilting suture versus conventional closure with drainage

Conditions: Breast Cancer

Summary: the objective of this study is to compare quilting suture of the "dead space" without drainage of the pectoral area to conventional closure with drainage to prevent post-operative seroma requiring intervention (aspiration or surgical intervention) within 21 days after mastectomy for breast cancer.

eligible patients are patients with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level i/ii axillary node dissection randomization will be stratified by center and by type of surgery (mastectomy alone/ mastectomy with sentinel node biopsy / mastectomy with axillary lymph node dissection). two follow-up visits will be performed: at 21 days and 9 months after surgery, these appointments are conventional, thus our trial will not modify usual follow-up.

Eligibility criteria:
inclusion criteria: * women ≥ 18 years and ≤ 85 years * women with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either alone or in association with sentinel lymph node biopsy or standard level i/ii axillary node dissection * women that give her informed written consent * french social security affiliation exclusion criteria: * any physical or psychiatric condition that could impair with patient's ability to cooperate with postoperative data collection. * women with indication of bilateral mastectomy or immediate reconstruction. * degenerative neuromuscular disease with thoracic muscular damage * planned ambulatory surgery

Keywords: breast cancer mastectomy seroma quilting suture
comparison of laparoscopic versus open gastrectomy for gastric cancer: a prospective randomized trial

Conditions: Gastric Cancer

Summary: the purpose of this study is to assess the usefulness of laparoscopic surgery for gastric cancer in comparison with open gastrectomy.

recently, in technical aspects, almost all kinds of open gastric cancer surgeries can be reproduced laparoscopically. however, many controversies exist due to no evidence and no long-term results. there was no prospective multi-center large-scale randomized controlled trial in the world on the long-term outcome of laparoscopic gastric cancer surgery. korean laparoscopic gastrointestinal surgery study group, therefore, proposed a multi-institutional prospective randomized trial on comparing laparoscopy-assisted versus open distal gastrectomy for gastric cancer (klass trial) after the feasibility and validity of these procedures had been evaluated by analyzing retrospective multi-center large series. this klass trial is supported by a grant for 2005 from the national r\&d program for cancer control, ministry of health \& welfare, republic of korea. nine surgeons from 9 centers are participating in this trial. all the participants performed more than 50 cases of open and laparoscopic gastrectomies, respectively and their institutes had more than 80 cases of gastric cancer surgeries per year. primary endpoint of this trial is to elucidate that there is no difference of overall and disease-free survivals between laparoscopic and open groups. the klass trial consists of 5 major subjects: comparison of 5-year overall and disease-free survivals, standardization of preoperative diagnosis, assessment of the quality of life, evaluation of postoperative inflammatory response and immune function, and cost-effectiveness. the klass trial will be able to validate and verify laparoscopic gastric cancer surgery.

Eligibility criteria:
inclusion criteria: 1. pathologically proven gastric adenocarcinoma 2. age: 20 \~ 80 years 3. preoperative stage: ct1n0m0, ct1n1m0, ct2an0m0 4. no history of other cancer 5. no history of chemotherapy or radiotherapy 6. written informed consent exclusion criteria: 1. asa \>3 2. combined resection 3. total gastrectomy

Keywords: gastric cancer laparoscopic surgery survival preoperative staging morbidity quality of life acute inflammatory reaction cost
the association of g9a protein and the outcome of patients with cervical cancer

Conditions: Cervical Cancer

Summary: g9a protein was approved to be highly associated with recurrence of breast cancer, gastric cancer, hepatocellular cancer, prostate cancer and lung cancer. therefore, the aim of this study was to clarify the association and g9a protein and cervical cancer by analyzing the immunohistochemical staining of g9a protein to the histopathologic specimen of cervical cancer and clinical data.


Eligibility criteria:
inclusion criteria: * cases with cervical cancer

Keywords: outcome of cervical cancer
stress reduction techniques and anxiety: therapeutic and neuroendocrine effects

Conditions: Generalized Anxiety Disorder

Summary: current therapies for generalized anxiety disorder (gad) have limited effectiveness. this study measures the efficacy of two different approaches to reducing anxiety and stress. one approach uses education, nutrition, exercise, and time management training, and another uses mindfulness meditation and yoga, which is taught as part of the mindfulness-based stress reduction (mbsr) course, an 8-week manualized mindfulness intervention. we hypothesize that the two approaches will reduce anxiety in individuals with gad in different ways. we will measure changes in stress hormones associated with these changes.


Eligibility criteria:
inclusion criteria: * adults with generalized anxiety disorder * medically healthy exclusion criteria: * substance abuse * history of other psychiatric diagnoses such as psychosis, obsessive compulsive disorder, ptsd * use of certain types of psychotherapy, meditation training, yoga * pregnant or lactating women
sleep deprivation and advancement of sleep period as treatment for bipolar depression.

Conditions: Bipolar Disorder

Summary: the purpose of this study is to determine if sleep deprivation and sleep phase advancement is effective treatment of bipolar patients in a depressive phase.

background: the onset of therapeutic action for most anti-depressive treatments is usually two weeks. during this period patients suffer from great symptomatic distress. treatment options that are effective in this period is therefore of interest for psychiatric wards. aim: to explore if sleep deprivation and three days sleep phase advancement is effective treatment for inpatients with bipolar disorder in a depressive phase. method: a randomized controlled trial with 24 patients diagnosed with bipolar disorder. patients will be randomized to treatment as usual in an psychiatric ward, or sleep deprivation and three days sleep phase advancement. patients in the treatment as usual group will be offered treatment with sleep deprivation and sleep phase advancement after five weeks if they still meet inclusion criteria.

Eligibility criteria:
inclusion criteria: * bipolar disorder, depressive phase exclusion criteria: * substance abuse, psychotic symptoms, suicidal intentions, active mania/hypomania.
personalized dc vaccine for lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the study is aimed to the test the efficacy and safety of neoantigen-primed dendritic cell (dc) cell vaccine therapy for refractory non-small cell lung cancer.

patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. the patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. this is a prospective exploratory trial. patients' rebiopsy tumor tissues are subsequent to whole exosome sequencing and possible neoantigens are identified. dc is in vitro primed with synthesized peptides. both adverse events and responses are recorded.

Eligibility criteria:
inclusion criteria: * pathologically confirmed non-small cell lung cancer * failed in previous standard chemotherapy and targeted therapy * anticipated life time \> 3month * karnofsky performance status 0-1 * rehabilitate from previous therapy * adequate organ functions exclusion criteria: * mixed histological types * tumor emergency * abnormal coagulation condition * contagious diseases, such as hepatitis b virus, hepatitis c virus, human immunodefficiency virus, tuberculosis infection * concomitant tumors * immunological co-morbidities

Keywords: advanced non-small cell lung cancer cell based therapy safety clinical efficacy
a pilot study to finetune skin processing procedures in recent vaccinees, prior to gekoskimm study initiation (gekoskimm-pilot)

Conditions: Yellow Fever

Summary: this pilot study aims to optimize the sample processing techniques for collecting and analyzing skin biopsies obtained from individuals routinely vaccinated against yellow fever. by addressing logistical challenges early, risks will be mitigated and the main study's efficiency will be enhanced. in order to do so, 15 participants will be identified at the itm polyclinic after receiving a yellow fever vaccination. participants will be invited to one study visit at the itm clinical trial site (cts) 28 days after vaccination to collect blood samples, skin punch biopsies and a minimally-invasive microbiopsy at the site of vaccination. to investigate the ideal location for the skin punch biopsies, participants will be divided in 3 groups; in the first 5 participants the biopsies will be taken directly on the vaccination site, for the next 5 participants, the biopsies will be taken at +/- 3 cm distance from the vaccination site, and for the last five participants, the biopsies will be taken at +/- 10 cm distance from the vaccination site.


Eligibility criteria:
inclusion criteria: * bmi lower than 30kg/m² * able and willing to provide written informed consent * having received a yellow fever vaccination 28 days (+2 or -2 days) ago exclusion criteria: * any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months prior to recruitment, except topical or short-term oral steroids * history of bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following venipuncture * any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study * tendency to keloid (scar) formation in response to skin damage skin diseases at the biopsy or vaccination site
all2008 protocol for childhood acute lymphoblastic leukemia intermittent versus continuous peg asparaginase

Conditions: Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to investigate if intramuscular peg-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-hr all will result in equal probability of event free survival

20% of children with all still fails to be cured. the all-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of nordic children and adolescents with all in comparison with the all-2000 protocol and previous nopho protocols. the specific and primary objectives of the randomised study is: to test if intramuscular peg-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-hr all will result in equal probability of efs. as secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed

Eligibility criteria:
inclusion criteria: * childhood all * all mandatory biological data are available6 * written informed consent has been obtained exclusion criteria: * bilineage all * pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week * all predisposition syndromes * previous cancer * off protocol administration of additional chemotherapy during induction therapy * sexually active females not using contraception * no allergic reactions to peg asparaginase

Keywords: acute lymphoblastic leukemia child peg-asparaginase efs efficacy childhood acute lymphoblastic leukemia
gas supply, demand and middle ear gas balance: specific aim 3c

Conditions: Healthy

Summary: this study will determine if gas can pass between the environment and the middle ear by way of the eardrum. this route of gas exchange was observed in animals but has not been studied in humans. if gas exchange across the eardrum is documented and the rate is sufficiently high, this can help explain certain past observations such as why middle ear pressure does not change very much in some children and adults when they have a cold or flu. the investigators also expect that the rate of gas exchange across the eardrum will depend on whether or not the eardrum has scarred or abnormally thin regions.

middle-ear (me) pressure is a measure of the number of contained gas moles, and processes that addd or remove gas moles from the relatively fixed volume me cavity change its pressure. experimental results from animal studies document significant gas exchange across the tympanic membrane and if confirmed for humans may explain some of the paradoxical findings for children with poor eustachian tube function such as the preservation of an aerated me when the normal routes of gas supply are disrupted. this study measures the rates of reactive and inert gas exchange across the adult tympanic membrane with and without structural abnormalities and determines if these transfers are purely diffusive phenomena. the resulting data will be used to develop species-specific rate-constants that will be used as parameters in modeling me pressure regulation.

Eligibility criteria:
inclusion criteria: * 18-50 years old * at least one intact and effusion-free middle ear exclusion criteria: * bilateral otitis media * unable to remain relaxed and quiet for up to 2 hours

Keywords: otitis gas diffusion eustachian tube tympanic membrane
monoclonal antibody therapy in treating patients with brain metastases

Conditions: Metastatic Cancer

Summary: rationale: monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: phase i/ii trial to study the effectiveness of monoclonal antibody therapy in treating patients who have brain metastases.

objectives: i. determine the toxicity and maximum tolerated dose of 131-iodine-labeled monoclonal antibody fragment me1-14 f(ab')2 administered intrathecally in patients with neoplasms metastatic to the leptomeninges. ii. identify objective therapeutic responses to this treatment. outline: radioimmunotherapy. iodine-131-labeled monoclonal antibody fragment me1-14 f(ab')2, 131i-me1-14 f(ab')2. projected accrual: three to 6 patients will be treated at each dose studied.

Eligibility criteria:
disease characteristics: histologically confirmed neoplasm that is recurrent in the subarachnoid space biopsy of recurrent lesion required if original diagnosis made more than 2 years prior to entry and csf cytology negative radiographic evidence of measurable lesion in the leptomeninges (by myelography, ct, or mri) or cytologic evidence of malignancy in the csf any type of neoplasm eligible provided tumor cells (tissue or csf preparation) bind significantly to intact monoclonal antibody me1-14 igg2a or to me1-14 f(ab')2 patency of subarachnoid pathways demonstrated by isotopic intraventricular flow patient characteristics: age: 3 and over performance status: karnofsky 50-100% hematopoietic: absolute neutrophil count at least 1,000/mm3 platelet count at least 100,000/mm3 hepatic: ast less than 1.5 times upper limit of normal (uln) alkaline phosphatase less than 1.5 times uln renal: creatinine less than 1.2 mg/dl other: no allergy to iodine not pregnant or nursing prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 4 weeks since prior antineoplastic chemotherapy unless unequivocal evidence of tumor progression no concurrent systemic chemotherapy endocrine therapy: corticosteroids allowed if at lowest possible dose and stable for at least 10 days prior to entry radiotherapy: at least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of disease progression surgery: not specified

Keywords: leptomeningeal metastases