Kornimate/medical-research-clean huggingface dataset:
spironolactone in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study aims to assess whether treatment with a drug called spironolactone, which is an aldosterone inhibitor, can improve ability to cope with exertion, quality of life and ability of the heart to relax better in symptomatic patients with atrial fibrillation with preserved pumping capacity.

impress-af study is a double-blinded randomised placebo-controlled trial of 2-year treatment with an aldosterone antagonist, spironolactone (25mg once daily) vs placebo in 250 patients with symptomatic chronic atrial fibrillation and preserved left ventricular contractility (both added to the current optimised care). the trial will establish impact of spironolactone on the primary outcome of exercise tolerance (peak oxygen consumption on cardiopulmonary exercise testing) and secondary outcomes: (i) health-related quality of life (assessed using the validated minnesota living with heart failure and euroqol eq-5d questionnaires self-completed by patients), and (ii) left ventricular diastolic function (e/e' ratio on echocardiography) - all assessed at baseline and at 2 years; (iii) rates of all-cause hospitalisations during 2-year follow-up.

Eligibility criteria:
inclusion criteria: * permanent af * left ventricular ejection fraction \>= 55% as established by echocardiography * able to perform cardio-pulmonary exercise testing using a cycling ergometer and complete quality of life questionnaires in english or in their native language. exclusion criteria: * severe systemic illness (life expectancy \<2 years) * severe chronic obstructive pulmonary disease (e.g., requiring home oxygen or chronic oral steroid therapy) * severe mitral/aortal valve stenosis/regurgitation * significant renal dysfunction (serum creatinine 220 µmol/l or above), anuria, active renal insufficiency, rapidly progressing or severe impairment of renal function, confirmed or suspected renal insufficiency in diabetic patients/ diabetic nephropathy * increase in potassium level to \>5mmol/l * recent coronary artery bypass graft surgery (within 3 months) * use of aldosterone antagonist within 14 days before randomisation * use of or potassium sparing diuretic within 14 days before randomisation * systolic blood pressure \>160 mm hg * addison's disease * hypersensitivity to spironolactone or any of the ingredients in the product * any participant characteristic that may interfere with adherence to the trial protocol
evaluation of a new blood glucose meter system with capillary and venous blood

Conditions: Diabetes Mellitus

Summary: the purpose of the study was to evaluate the performance of the meter system in the hands of subjects and healthcare professionals (hcps). it also evaluated the product user guides in the hands of untrained subjects.

the study evaluated the performance of the blood glucose meter system (bgms) compared to a laboratory glucose method. subjects and healthcare professionals tested subject capillary blood and healthcare professionals tested subject venous blood. two meter configurations were evaluated. the study evaluated the acceptability of product labeling in enabling subjects to perform blood glucose testing with the new meter system and for using meter features. subjects and healthcare professionals provided feedback about the bgms and its features.

Eligibility criteria:
inclusion criteria: * have type 1 or type 2 diabetes * be \> 18, \< 76 year of age at time of consent, with approximately 50% (+10%)being less than 55 years of age * be willing to complete all study procedures * be routinely testing their blood sugar at home (at least once per day) * be able to speak, read, and understand english and understand the informed consent document * be able to read the labeling instructions exclusion criteria: * minors \ 75 years of age * pregnancy * physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the bgms * disorders in the fingertip lancing areas * acute or chronic infections, particularly skin infections * infection with a blood borne pathogen * taking prescription anti-coagulants or having clotting problems that may prolong bleeding. taking aspirin daily (81 mg or 325 mg) is not reason for exclusion * hemophilia or any other bleeding disorder * having a condition which, in the opinion of the principal investigator or designee, would put the person at risk or seriously compromise the integrity of the study * working for a competitive medical device company
efficacy of silymarin for acute hepatitis

Conditions: Hepatitis

Summary: the overall objective of this project is to assess whether silymarin therapy shortens illness or prevents complications in patients with acute hepatitis. we will specifically compare responses in acute hepatitis patients treated with silymarin to those given a control preparation of a vitamin supplements in a double blinded, randomized, placebo-controlled trial.

the study is designed as a double-blinded placebo controlled trial. we compare a 4 week course of therapy with silymarin tablets and a low-dose vitamin preparation (placebo) and then follow-up for a total of 8 weeks to assess treatment response. outcomes of our randomized controlled trial are improvement in symptoms and signs, normalization of liver functions, time to resuming normal activities, and and sense of well-being. this protocol follows the standard therapeutic care for acute hepatitis except that the patients will receive either a herbal supplement (silymarin), which many patients are taking anyway, or a vitamin placebo. freshly collected serum will be tested for anti-hav igm, anti-hbc igm, anti-hbs, hbs ag, anti-hcv antibody, hcv-rna, anti-hdv igm, anti-hev igm, cmv and ebv and for alanine aminotransferase (alt), ast, direct and total bilirubin.

Eligibility criteria:
inclusion criteria: * patients admitted to the fever hospital and presenting with symptoms and signs that may be consistent with a diagnosis of acute hepatitis. * recent (\<1 month) history of illness. * elevation of alt \> 2.5 normal. * at least 13 years old. exclusion criteria: * history suggestive of severe drug-induced acute hepatitis. * children 12 years and younger. * pregnant or breastfeeding women * suspected hypersensitivity to silymarin or vitamin preparations. * evidence of advanced liver disease e.g. history or presence of ascitis, bleeding esophageal varices, and hepatic encephalopathy. * patients who are critically ill, with multisystem failure or cancer. * substance abuse such as iv drugs. * any other conditions, which in the opinion of the investigator would make the patient unsuitable for enrollment or could interfere with the patient's participation in and completion of the protocol.

Keywords: acute hepatitis acute viral hepatitis acute nonviral hepatitis silymarin milk thistle
double trunk mask and standard nasal cannula during acute hypoxia

Conditions: Hypoxia

Summary: the objective of the study is to determine whether adjunctive mask of our design (double trunk mask - dtm) has an effect on increasing arterial pressure in oxygen (pao2) diagnosed with severe hypoxia.

this is a single-center, randomized, blind investigator, 2-way crossover study design. enrolled participants had hypoxia being treated at intensive care unit associated with a hospital in hornu (epicura). the study consisted of two intervention periods separated by a washout period of 30 minutes. the objective of the study is to determine whether adjunctive mask of our design (double trunk mask - dtm) has an effect on increasing arterial pressure in oxygen (pao2) diagnosed with hypoxia. the protocol and informed consent documents were reviewed and approved by a recognized ethics review board at the study facility. the study was performed in accordance with the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * regardless of gender, at least 18 years of age and diagnosed with hypoxia (pao2/fio2 \< 380 mm hg), dyspnea, respiratory rate (rr) ≥ 25 cpm, paco2 ≤ 45 mmhg, patient with an arterial catheter and without hemodynamic instability, glasgow coma scale ≥ 12/15, written consent. participants were also required to have a sufficient level of education to understand study procedures and be able to communicate with site personnel. exclusion criteria: * patients were excluded if they hypercapnia (\> 45 mm hg with respiratory acidosis), copd, pulmonary fibrosis, hypoventilation obesity syndrome, arterial pressure \ to 0,1 gamma/kg/minute, deterioration of awareness (glasgow scale \< or = 12), acute confusional state. participants were randomized in a 1:1 ratio to receive either classical oxygenation with nasal cannula (nc) for 20 minutes or nc with an adjunctive of a double trunk mask.

Keywords: oxygen nasal cannula double trunk mask hypoxia
braining - evaluation of acute effects of physical exercise

Conditions: Psychiatric Disorder

Summary: "braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. the core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurements and evaluations before and after a training period. the scientific purpose of this study is to investigate immediate and short-term effects of a booster-session of several braining classes.

"braining" is a clinical invention that helps patients in psychiatry to start and execute physical exercise (pe) regularly in psychiatric care. the core components are basic moderate to vigorous aerobic group training sessions and motivational work led by the psychiatric staff. braining is used as add-on treatment to regular psychiatric care and is included in the patient care plan. in the present study, the focus is on the acute effects of a booster session of one to three braining classes on psychiatric symptoms and biomolecular markers as well as impact on motivational factors. participants are recruited from the final cohort (n = 51) of the previous retrospective study, (physical exercise as adjunctive therapy for affective disorder and anxiety).this final cohort will be contacted to give written consent to partake in the booster session. the braining classes each have a duration of 30 minutes and are scheduled over the course of a week. descriptive data on participating patients will be collected before the booster week. this will include age, gender, diagnoses, employment status. in conjunction with this, basic psychiatric and somatic examinations will be conducted. during each braining class, participants' activity level will be measured with a heart rate monitor to ascertain achieveing moderate to vigorous intensity. directly before and after each class, current anxiety level will be measured on a visual analogue scale 0-100. within 30 minutes before and after one braining class, venous blood samples (50 ml) will be taken for biomolecular markers. blood samples include 1) inflammation markers such as high-sensitivity c-reactive protein hscrp, 2) brain-derived neurotrophic factor bdnf, 3) telomerase activity and 4) epigenetic markers. before and after the booster week, self-assessments scales for anxiety and depressive symptoms will be administered. qualitative data on participants' experience as well as motivational factors will be collected.

Eligibility criteria:
inclusion criteria: * included in the retrospective study physical exercise as adjunctive therapy for affective disorder and anxiety and has given informed consent to participation in a braining booster session. exclusion criteria: * severe psychiatric disorder such as mania and psychosis * medical conditions such as heart- and lung diseases where pe is contraindicated. * unable to understand written and spoken swedish language.

Keywords: psychiatric disorder physical exercise
a study of participants in china with non-small-cell lung cancer that is unable to be treated with surgery

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a multicenter, observational cohort study in china with both primary prospective data collection and retrospective collection of prior treatment information from medical records, which enrolls and follows patients who are newly diagnosed with unresectable stage iiib/iiic/iv non-small-cell lung cancer (nsclc) in the selected sites. this study aims to describe the clinical practice and long-term survival benefits of patients newly diagnosed with unresectable stage iiib/iiic/iv nsclc. the study also seeks to explore the condition of biomarker tests utilization, and to assess potential economic impact on patients in the real world. the safety related events will also be summarized in this study.


Eligibility criteria:
inclusion criteria: cohort 1: * participants who have diagnosed with unresectable stage iiib/iiic/iv nsclc * participants who have been diagnosed six months before the start of the study were required to have two complete tumor assessments within at least 6 months intervals after the diagnosis * participants who were newly diagnosed within six months before the start of the study were required to have complete baseline information (see section 6.4.1) * participants who have received standard first-line treatment defined by guideline csco (https://www.csco.org.cn/cn/index.aspx) and nccn (https://www.nccn.org/) cohort 2: * participants who are newly diagnosed with unresectable stage iiib/iiic/iv nsclc after the start of the study * participants who are able to be followed up by the participating site * participants planned to receive first line anti-cancer treatment targeting unresectable stage iiib/iiic/iv nsclc in the study site after study initiation exclusion criteria: * participants who have received prior systematic treatment for unresectable stage iiib/iiic/iv nsclc * participants who have participated in any anti-cancer, regimen-specified clinical study of first-line treatment for unresectable stage iiib/iiic/iv nsclc

Keywords: non-small cell lung cancer
gem vs gem+ts-1 for advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the primary objective of this study is to compare tumor response rate of the test arm(gemcitabine+s-1) with the control arm(gemcitabine alone) in patients with unresectable pancreatic cancer

pancreatic cancer is the fifth leading cause of cancer death in the united states. it is difficult to diagnose at its early stage and only 10-20% of patients are candidates for resection with 5-year survival rate of less than 10%. patients with unresectable pancreatic cancer has a poor prognosis. gemcitabine, a cytidine analogue, is the standard chemotherapeutic agent for the disease with median survival time(mst) ranging from 6 to 8 months. phase ⅲ study showed that combinations with other drugs, such as oxaliplatine or cddp, did not contribute to survival time. ts-1, a new oral fluoropyrimidine which consists of the 5-fu prodrug tegafur (ftorafur, ft) and two enzyme inhibitors, cdhp (5-chloro-2,4-dihydroxypyridine) and oxo (potassium oxonate), in a molar ratio of 1(ft):0.4 (cdhp):1(oxo), is commercially available since late 90'in japan. phase ii trials have demonstrated that s-1 was effective as a single agent for treatment of gastric (rr 44.6%), colorectal (rr 37.4%), head and neck, breast, non-small cell lung, and pancreatic cancers(20%). a combination of gemcitabine and ts-1 is found to be effective and promising in phase ⅱ trial for metastatic pancreatic carcinoma in selected subjects, but the combination therapy has high rate of side effects. this phase ⅱ randomized controlled study compares efficacy and feasibility of gem+s-1 with gem alone in patients with locally advanced and metastatic pancreatic cancer and performance status of 0-2, aiming at patients in rather ordinary clinical settings.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically proven unresectable pancreatic carcinoma 2. there must be measurable lesions with multislice ct 3. ecog performance status 0-2 4. no other active cancer 5. no previous therapy such as radiotherapy, chemotherapy and immunotherapy 6. adequate organ functions are preserved as wbc more than 4000/mm3,hb more than 8.0g/dl,neutrophil more than 2000/mm3,platlet more than 100,000/mm3, ast less than 2.5 x normal or less than 5.0 x normal if the patient had known liver metastasis, bilirubin less than 2.0mg/dl, ccr more than 60ml/min 7. no serious complications 8. be able to eat food 9. life expectancy of more than 8 weeks duration 10. informed consent is obtained- exclusion criteria: 1. interstitial pneumonia 2. uncontrollable diabetes, liver dysfunction, angina pectoris,or myocardial infarction with its onset within 3 months 3. serious infection 4. pregnant or lactating females 5. history of serious drug allergy 6. serious other complications 7. uncontrolled mental disorders -

Keywords: pancreatic carcinoma gemcitabine s-1 phaseⅱstudy
early detection of anaemia during the maternity

Conditions: Anemia

Summary: estimate the efficiency of a strategy of premature screening of the maternal anaemia during the first quarter of pregnancy versus the usual strategy of screening of the anaemia during the sixth month.

a part of the patient will have a nfs and dosage of the cast-iron, during the results of the beginning of the pregnancy at the first quarter. the other part of the patients will have a nfs and at the first quater of the pregnancy. all the patient will have a nfs at the results of the sixth month of the pregnancy. a nfs will be done during the results at the end of the pregnancy like we do now. then a nfs at 48 hours after the birth. a treatment with iron will be done and according to the results

Eligibility criteria:
inclusion criteria: * every patient followed at the hme at the beginnig of the pregnancy exclusion criteria: * pregnency women who don't speak french * pregnancy women affected by béta thalassemia * pregnancy woman having had a périconceptionnel treatment against the anaemia

Keywords: aneamia aneamia during the maternity
study of the icg distribution in breast tumours or in axillary lymph nodes of patients after neoadjuvant therapy

Conditions: Breast Cancer

Summary: we will verify if iv injected icg may colour breast tumors and axillary lymph nodes after neoadjuvant therapy (chemo- or hormonotherapy)

in the operating room: icg 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation. optionally, dynamic nir imaging centered on the tumor bearing breast will be acquired during the 15 minutes after injection (in comparison with standards of known fluorescence intensity). optionally and in case of tumorectomy, peroperative "in vivo" imaging of the surgical dissection will be acquired. the tumour and/or the mammary piece (and the axillary piece) of dissection will be directly imaged "ex vivo" using the pde camera (in comparison with standards of known fluorescence intensity). in the laboratory of pathology: the fresh mammary piece will be processed as usual, but the "gross-thick" sections will be imaged using the pde and the fluorescent areas will be defined (and later analyzed in comparison with standards of known fluorescence intensity). after fixation, the tumoral tissues as well as - if identified - non tumoral fluorescent foci will be thereafter processed "as usual". all the slides obtained will be analyzed using the nir fluorescent microscope for the presence or not of detectable icg and the icg-positive tissues or compartments (vascular spaces, interstitial spaces, normal and/or tumoral cells, macrophages...) will be determined. if fluorescent foci are identified at the level of the axillary piece, they will be isolated and analyzed like the other lymph nodes. using the nir fluorescent microscope, these isolated macroscopically fluorescent structures will be analyzed (lymph node? other?). additionally, metastatic lymph nodes will also be controlled for their microscopic fluorescence or not.

Eligibility criteria:
inclusion criteria: * patients with histopathological diagnosis of mammary cancer who have received neoadjuvant therapy and are candidate, either for tumorectomy, or for mastectomy with complete axillary node dissection, * informed consent form signed. exclusion criteria: * diagnosis of mammary cancer established, either by tumorectomy, or by "gross" biopsy, * age less than18 years old. * inability to give informed consent. * history of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish. * apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland. * documented coronary disease. * advanced renal impairment (creatinine \> 1,5mg/dl). * during the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of icg (i.e. anticonvulsants, haloperidol and heparin). * pregnancy, breastfeeding

Keywords: neoadjuvant therapy
the modulatory role of communicated treatment rationale on treatment expectation effects in depression.

Conditions: Condition: Major Depressive Disorder (MDD)

Summary: placebo groups in clinical trials on depression show impressive improvements. yet, there is little research on the mechanism underlying this effect. the aim of this study is to assess how patients' treatment expectations modulate the placebo treatment effects. we expect that patients' treatment expectation determines placebo responses and treatment outcomes, and that this expectation is influenced by the disorder explanations (information about the illness models) typically provided during the initial medical encounters that precede treatment. in the study we aim to manipulate depressed patients' expectations by providing two different clinician-delivered illness and treatment rationales (biological/ psychological). patients will then receive placebo treatment (pharmacological/ psychological), that is either congruent or incongruent with the previously communicated treatment rationale. hypotheses: 1. providing a treatment-congruent treatment rationale leads to a better outcome than providing treatment-incongruent rationales. 2. treatment-congruent explanations reduce the risk of side effect development, in particular in the medication arm. 3. inter-individual differences in the effect of provided treatment rationale are associated with pre-treatment experiences and expectations, depression severity and comorbid anxiety.


Eligibility criteria:
inclusion criteria: * diagnosis of major depression according to the 'structured clinical interview for dsm-v' (scid) * age\>17 * comorbidity is allowed if major depression is the dominant clinical problem * concordant medication is allowed if kept constant for the four weeks before and until the end of the trial (with the exception of benzodiazepines and if not contraindicated together with buscopan) * fluency in german * informed consent exclusion criteria: * severe depression (bdi\> 30) or suicidality * psychosis * significant neurological diseases * other mental or physical disorder with substantial influence on disability * benzodiazepine intake * any intolerance against buscopan and sucrose or any medical condition/treatment conflicting with buscopan intake

Keywords: placebo effect treatment rationale depression expectations