Kornimate/medical-research-clean huggingface dataset:
pre-operative exercise during neoadjuvant chemotherapy in patients with breast cancer

Conditions: Breast Cancer

Summary: the neo-train study is a randomized controlled trial investigating the effects of supervised pre-operative aerobic and resistance exercise in patients with breast cancer during neoadjuvant chemotherapy.

the long neoadjuvant chemotherapy period in patients with breast cancer brings a time window of opportunity to investigate the potential of pre-operative exercise to increase treatment efficacy with improved tumour regression. a possible improvement in chemotherapy completion, lift in physical function, alleviated toxicities as well as changes in biological markers can also be investigated. 120 patients with newly diagnosed breast cancer who start neoadjuvant chemotherapy will be randomized to the intervention arm (n=60) and control arm (n=60). participants in the intervention arm will be prescribed a prehabilitation program consisting of thrice weekly combined supervised aerobic and resistance exercise during the neoadjuvant chemotherapy period. participants will be screened for psychological distress four times and in case of moderate-severe distress be advised to visit the local cancer society support center where participants will be assessed and offered free services based on their psychosocial needs and available offers. participants in the control arm will receive usual care. outcomes will be measured at baseline (diagnosis), during neoadjuvant chemotherapy, during the week before breast surgery, at breast surgery and at 3 months follow up. the participants will receive the recommended neoadjuvant chemotherapy regimens in denmark - currently up to 24 weeks. with expected chemotherapy dose delays, the time of breast surgery is expected to be within 30 weeks from baseline. the treatment plans will be individually modified based on tumour response and expected side effects to treatment. a subgroup of participants may change neoadjuvant chemotherapy regimen and be referred to breast surgery early. in these participants, the last measurement during chemotherapy will be used, and the 3 months follow up measurement will still be scheduled at 3 months after breast surgery. the study procedures will be pre-tested in a pilot study with 6 patients who will all receive the prehabilitation program.

Eligibility criteria:
inclusion criteria: * patients newly diagnosed with histologically verified breast cancer and scheduled for neoadjuvant chemotherapy * female gender * aged ≥ 18 years old * signed informed consent exclusion criteria: * patients ineligible for or who have declined to receive neoadjuvant chemotherapy * contraindications to magnetic resonance imaging (mri) * physical or cognitive disabilities preventing exercise or physical testing * inability to read and understand danish * based on clinical judgement, the physician assesses that the patient is not suitable for inclusion

Keywords: prehabilitation pre-operative exercise breast cancer tumour regression neoadjuvant chemotherapy
non surgical treatment (microwave ablation) of breast cancer

Conditions: Breast Cancer Stage I

Summary: in the netherlands approximately one out of seven women will develop breast cancer during her life. most of these breast cancers are early stage, 40% of the women have stage 1. stage 1 breast cancer means that the cancer is small (size \<2cm) and only in the breast tissue or it might be found in lymph nodes close to the breast. the standard treatment for stage 1 breast cancer is breast conserving surgery (bcs), sentinel lymph node procedure (slnp) and additional radiotherapy. this standard treatment protocol results in a10 years survival rate of 95% for stage 1 disease. however, nowadays there is a discussion whether these early stage breast cancer could be treated less invasively. to reduce the invasiveness of breast cancer treatment, without compromising breast cancer specific survival, minimally invasive ablation procedure of the breast tumor can be an option for small breast lesions. patients with a tumor size\<2 cm will undergo ultra guided microwave ablation (mwa) with local anesthesia. after a small incision 2-3 millimeters, an mwa electrode is placed at the end of the tumor with ultrasound guidance. the microwaves in mwa create heat around the needle and destroy the cancer cells. there are several advantages of ablation procedures: it is a minimal invasive technique, with a small or absent cutaneous scar and thereby potentially improving patient quality of life. furthermore, ablative treatment can be done under local anesthesia and/or conscious sedation instead of general anesthesia and in daycare setting, which can reduce treatment cost. a post procedural mri (after ablation) can determine whether the ablation procedure of the tumor volume is complete. the purpose of this study is to assess whether minimally invasive microwave ablation (mwa) followed by postprocedural mri scan can be an alternative treatment for breast surgery in early stage breast cancer. is the quality of life, the cosmetic outcome, fear of breast cancer recurrence, and costs in patient treated with mwa comparable or better compared to patients treated with breast surgery?


Eligibility criteria:
inclusion criteria: * age should be 18 years and older * a solid non-lobular invasive breast tumor with a size \<2cm based upon ultrasound and mri measurements * without mammographic or mri evidence of extensive disease * no involved lymph nodes on ultrasound and mri scan. exclusion criteria: * more than one breast tumor, * (lymph node) metastases * breast implants * indication for neoadjuvant chemotherapy. * pacemaker, * pregnant * breastfeeding

Keywords: breast cancer microwave ablation mri
a registry to evaluate safety, performance, and clinical benefit of beflow

Conditions: Iliac Artery Stenosis; Iliac Artery Occlusion

Summary: this international, observational multi-centre registry of the device bfi will monitor technical success of the implantation, data regarding clinical performance, clinical benefit, as well as potential unknown side effects pursuant to the intended purpose.


Eligibility criteria:
inclusion criteria: * patients with an indication for permanent intraluminal placement in iliac arteries for restoring and improving the patency impaired by arteriosclerosis or other stenoses that may be treated by stenting according to the ifu of the bfi * patient is capable and willing to sign an informed consent * patients ≥18 years of age at the time of consent exclusion criteria: * patients with any contraindication according to the ifu * previous stenting of the target vessel
validation of a smartphone-based recorder for detection of cardiac arrhythmias

Conditions: Cardiac Arrhythmia

Summary: the investigators will evaluate the diagnostic yield of the new alivecor device versus a 12 lead ecg when used simultaneously to detect cardiac arrhythmia

the investigators are planning to record 250 pre-defined abnormal ecgs (50 each of atrial fibrillation, atrial flutter, pre-excitation, ventricular tachycardia, , supraventricular tachycardia) and 150 control ecgs (100 sinus rhythm, 50 sinus tachycardia) using both the alivecor smartphone device and a 12-lead ecg. all 400 ecgs will then be read by 3 blinded reporters - a consultant electrophysiologist, a consultant general cardiologist and a general practitioner. the output of the alivecor automatic detection algorithm will also be recorded as a fourth reporter. the screening characteristics of all 4 reporters using the alivecor device vs the definitive 12 lead ecg will be analysed and compared.

Eligibility criteria:
inclusion criteria: * male or female patients \>18 years * 12 lead ecg finding of arrhythmia, manifest pre-excitation, pacing rhythm (in the ep lab), sinus rhythm or sinus tachycardia exclusion criteria: * age \<18 years * patients unable to or unwilling to use the device * patients with cardiac pacemaker, icds, or other implanted electronic devices
transient elastography in autoimmune hepatitis

Conditions: Liver Cirrhosis

Summary: recent, research has focused on the evaluation of non-invasive methods for the assessment of liver fibrosis in patients with chronic liver disease. among these methods, transient elastography is the most promising. the method has been investigated mainly in patients with viral hepatitis. several studies have shown, that the optimal cut-off value of te for detection of liver cirrhosis by transient elastography is highly dependent on the aetiology of the underlying liver disease. only a few studies have evaluated the value of transient elastography for patients with autoimmune liver disease and here primarily patients with pbc and psc. for patients with autoimmune hepatitis the data is limited. we prospectively investigated the diagnostic accuracy of te in autoimmune hepatitis compared to liver histology with and without inclusion of the macroscopic appearance using mini-laparoscopy

the aim of the current study was to assess the diagnostic performance of transient elastography for the determination of cirrhosis in patients with autoimmune hepatitis compared to the diagnosis of cirrhosis made on laparoscopic guided liver biopsy. patients referred for liver biopsy and transient elastography with a clinical diagnosis of aih followed in the liver clinic of the department of gastroenterology at the uke were prospectively included in the study. inclusion criteria were as follows: confirmed diagnosis of aih based on the diagnostic criteria revised by the international autoimmune hepatitis group 2008 (20): 1. liver related autoantibodies, 2. hypergammaglobulinaemia, 3.typical histological findings and 4. absence of viral markers. exclusion criteria were morbid obesity (bmi \> 40), ascites, ileus or subileus, peritonitis, pregnancy, extrahepatic cholestasis and a severe inflammatory flare of aih. blood liver tests including gamma-globulines, igg, igm, liver related autoantibodies (ana, ama, lkm, sma, sla) and viral markers (hbsag, anti hbs, anti hbc, anti hcv, anti hav) were performed before lb. each patient underwent abdominal ultrasound to exclude extrahepatic cholestasis prior to te and minilaparoscopic liver biopsy. te and minilaparoscopy were performed by physicians blinded to the results the other within a period of less than 3 months.

Eligibility criteria:
inclusion criteria: confirmed diagnosis of aih based on the diagnostic criteria revised by the international autoimmune hepatitis group 2008 (20): 1. liver related autoantibodies, 2. hypergammaglobulinaemia, 3. typical histological findings and 4. absence of viral markers. exclusion criteria: * morbid obesity (bmi \> 40), * ascites, ileus or subileus, * peritonitis, * pregnancy, * extrahepatic cholestasis and * a severe inflammatory flare of aih.

Keywords: transient elastography mini-laparoscopy liver biopsy liver cirrhosis autoimmune hepatitis
a clinical study of omega-3 on depression and cognition

Conditions: Depression

Summary: depression is a serious mental illness, with persistent depression and loss of interest as the main clinical manifestations, and causes varying degrees of cognitive impairment, further leading to impaired social function, and even lead to suicidal behavior. previous studies on the antidepressant effects of omega-3 mainly focused on chronic effects, and there was a lack of corresponding rapid response clinical studies. because of the nature of omega-3 health products, no clinical adverse effects have been reported. we have previously shown that omega-3 can produce antidepressant and cognitive improvement effects. this study will carry out different doses (low dose and high dose) and single active ingredient (epa alone) to observe the antidepressant and cognitive improvement effects of omega-3 in clinical patients with major depression. the antidepressant effect and cognitive improvement effect of omega-3 will be further verified to provide evidence for future clinical application.


Eligibility criteria:
inclusion criteria: * current moderate to severe depressive episode (dsm-5) * hamd-17\>16 * 18≤age≤45 * never use of fluoxetine and no use of any antipsychotic and antidepressant drugs and mood stablizer at least 8 weeks * current physical or laboratory tests show good health * negative usrine drug tests * voluntray to sign the consent form exclusion criteria: * treat-resistant depressive disorder * other axis i/ii dignoses * mmse≤27 recent abuse history of alcohol or drugs pregnant or breast breeding

Keywords: omega-3 cognition depression
extracorporeal photopheresis in children and young adults with refractory acute graft versus host disease

Conditions: Graft Versus Host Disease

Summary: purpose : to evaluate the efficacy of ecp in children with refractory acute gvhd this study addresses patients with persistent gvhd after steroid and/or monoclonal antibody therapy

one arm. six sessions in two weeks. classification in complete response (resolution of all signs of gvhd), partial response (improvement of at least one grade) or absence of response (glucksberg criteria). tapering depending on patient condition during weeks 2 to 10. final evaluation at week 10. steroid therapy tapering at the discretion of the investigator.

Eligibility criteria:
inclusion criteria: * 0 to 30 years * acute gvhd refractory to steroids (disease progression after 2 days or absence of response after 4 days) and/or second line therapy (absence of response after 8 days) * patient consent and/or parent consent exclusion criteria: * less of 10 kgs bw * clinical or biological state precluding the apheresis * previous gvhd therapy with anti-lymphocyte serum (excepted in the conditioning regimen)

Keywords: 0 to 30 years refractory acute gvhd
bone marrow derived ac 133+ and mono-nuclear cells (mnc) implantation in myocardial infarction (mi) patient

Conditions: Myocardial Infarction

Summary: although a percutaneous coronary intervention (pci) can be used to open up the blocked artery and restore blood flow to the heart muscle after myocardial infarction, there may be a significant amount of heart tissue that has been irreversibly damaged. recent studies have shown that adult stem cells from bone marrow may be able to improve heart function and prevent from heart remodeling due to heart failure. this study will evaluate the safety and effectiveness of using adult bone marrow derived stem cells for improving heart function in mi patients with left anterior descending (lad) involvement.

patient from both gender, who had acute mi within recent 3 weeks in lad territory and would underwent pci are eligible for this study. the bone marrow derived ac 133+ and mnc would be intracoronary injected to the patients during pci procedure. the control group would be received just serum during pci. the patient would be followed every month and at the end of 6th and 18thmonth the case and control groups will be evaluated by stress echo and tc99 scan. the totality of evidence from trials investigating autologous whole bone marrow infusion into patients following myocardial infarction supports the safety of this approach in terms of efficacy

Eligibility criteria:
inclusion criteria: * bmi\> 30 * first acute mi in lad territory * st elevation mi * ejection fraction: 20-45% * at least two non - mobile or less mobile segment of left ventricular myocard. * successful pci with stenting exclusion criteria: * multivessel ceremony artery disease * pulmonary edema * sbp \< 80 mmhg * thrombocytopenia (plt \< 50, 000) * inr \> 2 * hepatic failure or dysfunction * renal failure or dysfunction * positive hiv ab/ hbc ab/ hcv ab/ hsv ag * documental terminal illness * documental malignancy * patient with sever coronary disease and unstability of vital sign * history of leukopenia, anemia, hepatic or renal dysfunction or malignancy

Keywords: myocardial infarction bone marrow stem cell ac133 mono nuclear cell
bempedoic acid pregnancy surveillance program

Conditions: Pregnancy; Hyperlipidemias

Summary: bempedoic acid pregnancy surveillance program

a surveillance study of females exposed to bempedoic acid or bempedoic acid/ezetimibe fixed combination drug product (fcdp) during pregnancy. observational outcome data will be collected on pregnant females through pregnancy and infants through the first year of life.

Eligibility criteria:
inclusion criteria: exposure to at least 1 dose of bempedoic acid or bempedoic acid/ezetimibe fcdp at any time during pregnancy (from first day of last menstrual period \[lmp\] to pregnancy outcome exclusion criteria:

Keywords: bempedoic acid
renal transplant outcomes after cardiac surgery (retrocar)

Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Renal Transplant Recipient

Summary: in this retrospective study, the authors assess long term renal outcome in renal transplant recipients after cardiac surgery with cardiopulmonary bypass, and research factors associated with poor long term renal outcome.

post-operative mortality after cardiac surgery is increased in renal transplant recipients, compared with general population of cardiac surgery, or with kidney transplant recipients not undergoing cardiac surgery. if the survival of this specific population is now well studied, the long-term renal outcome is much less studied. previous studies show a trend for increased risk of allograft dysfunction and need for permanent dialysis. this study proposes to compare long term renal outcome between renal transplant recipients and non-renal transplant recipients.

Eligibility criteria:
inclusion criteria for renal transplant recipients group: * previous renal transplantation * who underwent cardiac surgery with cpb inclusion criteria for non renal transplant récipients group: * no previous renal transplantation * who underwent cardiac surgery with cpb * apparied with renal transplant récipients with the 5 following criteria : age, sex, previous diagnosis of diabete, type of cardiac surgery (isolated coronary artery bypass graft, valvular surgery, aorta surgery, combined surgery), best glomerular filtration rate with ckd-epi formula at +/- 15 ml/min, in the 3 pre-operative months exclusion criteria: * patients requiring mechanical circulatory support (extracorporeal membrane oxygenation) * pre-operative permanent dialysis * aorta dissection extended to renal arteries * non-elective surgery for infective endocarditis * previous hepatic, pancreatic or cardiac transplantation * death in the 30 first days after cardiac surgery * patient not meeting the inclusion criteria

Keywords: cardiac surgery renal transplant recipient renal function acute kidney injury major adverse kidney events
localization of anatomical structures involved in nodal tachycardias by high density mapping.

Conditions: Atrioventricular Nodal Reentry Tachycardia; Supraventricular Tachycardia

Summary: the aim of the present work is to analyze the capacity of high resolution mapping systems to determine the precise location of the av node and peri-nodal slow-conducting pathways, using standard recording parameters, but also off-line additional filter changes and additional techniques (conduction velocities, isochrones and dv/dt). the investigative team plan a prospective monocentric study. detailed high resolution mapping of the koch triangle and neighboring areas will be collected through the rhythmia hdx 3d electro-anatomical mapping system and the multipolar orion catheter. this sample will consist of 2 groups of patients: the first will include patients referred for avnrt ablation and the second will include control patients (without avnrt), referred for another indication requiring similar mapping system. if visualized, position of the slow pathway and av node will be compared with the ablation areas, which will be set conventionally under fluoroscopy.


Eligibility criteria:
inclusion criteria: group 1: patients without heart disease presenting with reciprocal tachycardia by intra-nodal reentry. group 2: control subjects, without nodal tachycardia, without heart disease, and admitted for ablation of atrial fibrillation or ventricular extrasystoles on a healthy heart and with a 3d system. exclusion criteria: * presence of underlying structural heart disease or history of atrial ablation or atrial tachycardia * minor or protected patient * patient under guardianship, curatorship or safeguard of justice

Keywords: voltage mapping atrioventricular node mapping
the effect of bronchodilator on eosinophilic bronchitis and cough variant asthma

Conditions: Eosinophilic Bronchitis; Cough Variant Asthma

Summary: this study aim is to observe the response to bambuterol hydrochloride tablets treatment in subjects with eosinophilic bronchitis . the investigators hypothesize: a few of subjects with eb have some responses to bambuterol hydrochloride tablets therapy. most of subjects with cva respond well to bambuterol hydrochloride tablets therapy

study groups: 45 patients with chronic cough will be collected and two groups will formed based on diagnosis as follows: group 1: eb group the patients with eosinophilic bronchitis received bambuterol hydrochloride tablets 10mg q24 for three days . group 2: cva group the patients with cough variant asthma received bambuterol hydrochloride tablets 10mg q24 for three days . observe the response to bambuterol hydrochloride tablets treatment three days later and compare the effective rate of patients with eb and cva. then the study will be over.

Eligibility criteria:
inclusion criteria: 1. patients who have a history of cough as sole or main symptom lasting more than 8 weeks. 2. patients whose chest x-ray outcome was normal or without any active focus. 3. patients with eosinophilic bronchitis who were diagnosed with the result of sputum eosinophil percentage (eos%) over 2.5%, and the negative result in bronchial provocation test by methacholine inhalation challenge. 4. patients with cough variant asthma have positive result in bronchial provocation test. 5. patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old). exclusion criteria: 1. patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history \>10 pack-years or equivalence. 2. patients with concomitance of gerc (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, acei induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction. 3. female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study. 4. subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. these diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia. 5. subjects who demonstrate significant abnormality on biochemistry, hematology, ecg. 6. patients who does not cooperate with us.

Keywords: eosinophilic bronchitis cough variant asthma bronchodilator