Kornimate/medical-research-clean huggingface dataset:
outcomes of the spanish cohort of early access to pertuzumab and trastuzumab emtansine

Conditions: Breast Neoplasms

Summary: the overall study objective is to evaluate the effectiveness and safety of trastuzumab emtansine (t-dm1) and pertuzumab under real-world disease conditions in the spain, and specifically in patients treated under compassionate use or early access program

this is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the spain. the study design will reflect real-life clinical management of patients with her2-positive mbc. type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice. the analysis of the efficacy and safety results obtained in patients receiving pertuzumab or tdm1 in those early access systems is of utmost importance. these real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.

Eligibility criteria:
inclusion criteria: * adult patients (age ≥ 18 years at enrolment) with her2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with trastuzumab emtansine (t-dm1) or pertuzumab. * patients who initiate trastuzumab emtansine (t-dm1) and pertuzumab under spanish compassionate use or early access program. exclusion criteria: * given the characteristics of the study there are no exclusion criteria.

Keywords: advanced her2+ breast cancer pertuzumab trastuzumab emtansine compassionate use early access program effectiveness safety
the assessment of nutritional status of patients with ipf

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the aim of this study is to comprehensively evaluate the nutritional status of ipf patients and to evaluate the effectiveness of 3-month dietary counselling. in this study, the nutritional status of ipf patients followed in atatürk sanatorium training and research hospital were comprehensively evaluated. a comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, hand dynamometer, pulmonary function, and food frequency. also quality of life were assessed by sgrq. tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.

idiopathic pulmonary fibrosis (ipf) is an irreversible interstitial lung disease of unknown etiology, characterized by progressive loss of lung function. ipf is a disease of advanced age. preliminary studies of ipf indicate that nutritional status may affect quality of life and prognosis, but the clinical significance of nutritional status has not been investigated. weight loss is recognized as a common complication of ipf. there is no study that comprehensively evaluates the nutritional status of ipf patients in turkey. the aim of this study is to comprehensively evaluate the nutritional status of ipf patients and to evaluate the effectiveness of 3-month dietary counselling. in this study, the nutritional status of ipf patients followed in atatürk sanatorium training and research hospital were comprehensively evaluated. a comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, dynamometer, pulmonary function, and several questionnaires. so quality of life were assessed by sgrq. all measurements were taken at the baseline. then, tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ipf exclusion criteria: * not giving written consent

Keywords: idiopathic pulmonary fibrosis nutritional assessment dietary counselling
intrathecal administration of baclofen (itb) to cerebral palsy patients with therapy-resistant spasticity

Conditions: Cerebral Palsy

Summary: evaluation of the effect of intrathecal administration of baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales

evaluation of the effect of intrathecal administration of baclofen on spasticity of cerebral palsy patients, by means of standardized and internationally accepted scales

Eligibility criteria:
inclusion criteria: * cp patients with therapy-resistent spasticity * patients with sufficient body weight in relation to the volume * oral medication has failed: insufficient effect or too many side-effects * the patient and family understand the objectives of the treatment and accept those objectives * informed consent exclusion criteria: * contra-indications for surgery (e.g. infection) * hypersensitivity to oral baclofen
norwegian study of persistent atrial fibrillation treatment: cryoballoon versus radiofrequency catheter ablation

Conditions: Persistent Atrial Fibrillation

Summary: this study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment of patients with persistent or longstanding persistent atrial fibrillation.

the purpose of this randomized clinical trial is to compare the efficacy and safety of pulmonary vein isolation with either the second generation cryoballoon (arctic front advance™) or a radiofrequency ablation technique with an irrigated ablation catheter (tacticath™ quartz) . a total of 128 patients with persistent or longstanding persistent atrial fibrillation will be randomized for either radiofrequency or cryoballoon ablation treatment. with both techniques, pulmonary vein isolation will be performed and confirmed by a circular mapping catheter. the primary endpoint is freedom of any atrial arrhythmia recurrence at 12 months.treatment success will be evaluated by using 12-lead electrocardiography and 7-day holter recording.

Eligibility criteria:
inclusion criteria: * patients plan to undergo pulmonary vein isolation as the first procedure for symptomatic persistent atrial fibrillation (\>7 days) and longstanding persistent atrial fibrillation (\> 12 months, but ≤ 3 years) who are refractory to at least one class i or class iii antiarrhythmic drug and required at least one electrical or pharmacologic cardioversion. * subject is at least 18 and ≤ 75 years old. * subject is able and willing to give informed consent. exclusion criteria: * subject has paroxysmal atrial fibrillation (\ 3 years. * subject has any previous left atrial ablation procedure or surgery, including pulmonary vein isolation. * subject has presence of an intracavitary thrombus. * subject has uncontrolled heart failure. * subject has severe valvular disease. * subject has the left atrial diameter \> 60 mm confirmed by echocardiography. * subject has contraindications to systemic anticoagulation with heparin or oral anticoagulants. * subject has known cryoglobulinaemia. * subject has severe renal dysfunction. * subject who is or may potentially be pregnant. * subject has unstable angina pectoris. * subject has history of previous myocardial infarction or percutaneous intervention during the last three months. * subject has chronic obstructive pulmonary disease with detected pulmonary hypertension.

Keywords: atrial fibrillation catheter ablation
magnetic resonance spectroscopic imaging (mrs) and tumor perfusion of human glioblastoma treated with concurrent radiation therapy and temozolomide

Conditions: Glioblastoma; Glioma

Summary: the purpose of this study is to learn whether 3 tesla (3t) mri functional imaging will map a tumor more accurately allowing a more targeted delivery of radiation. the investigators hope to learn whether tomotherapy will be able to deliver higher radiation doses safely to the tumor while sparing the surrounding normal tissue.


Eligibility criteria:
inclusion criteria: * histologically confirmed glioblastoma multiforme * ages 18-65 * karnofsky performance scale (kps) equal to or less than 70 * minimal neurological deficit * eligible for concurrent temozolomide chemotherapy exclusion criteria: * prior radiation therapy to hand or neck area, chemotherapy, or radiosensitizer

Keywords: magnetic resonance imaging, functional radiation therapy temozolomide functional imaging concurrent chemoradiation
acute myocardial infarction: prognostic and therapeutic evaluation

Conditions: Acute Coronary Syndrome; Myocardium; Injury

Summary: amipe is both a retrospective and prospective study which was designed in order to collect data of patients with acute coronary syndromes and myocardial injury and to improve the knowledge about these conditions.

amipe is an observational, multicenter and both retrospective and prospective study enrolling a cohort of consecutive incident patients admitted to participating hospitals with a diagnosis of acute coronary syndrome or myocardial injury from 01/01/2016 to 31/12/2023. the aim of this study is to create a database including a comprehensive characterization of these patients in order to obtain new scientific evidence about these conditions. informations about the patients will be gathered from in-hospital medical records. a written informed consent is needed for every prospective patients enrolled in the study, in particular, the main objectives of the study are: * document the characteristics of all patients presenting with acute coronary syndrome and myocardial injury; * document the long term outcome rates; * document the therapeutic regimens and investigation conformity of treatment with already established guidelines. every diagnostic or therapeutic intervention will be in accordance with established guidelines and good clinical practice. statistics will be conducted utilizing univariate and multivariate analysis for outcomes. in particular for what concerns univariate analysis, ordinal variables will be analysed with t-test and mann-whitney test, whereas categorical responses with fischer exact test and with pearson chi-square test. multivariate analysis will be conducted with logistic regression for dichotomous variables, with mixed generalized linear model for ordinal or nominal variables and with anova or manova for continuous variables.

Eligibility criteria:
inclusion criteria: * patient aged \> 18 years old * acute coronary syndrome or myocardial injury * written informed consent exclusion criteria: * under age or not able to give informed consent

Keywords: acute coronary syndrome myocardial injury acs minoca
dinoprostone induction vs. expectant management after prom at term

Conditions: Prelabor Rupture of Membranes

Summary: prelabour rupture of membranes (prom) is associated with intrauterine infection and maternal and neonatal consequences. this risk increases with the length of time from prom to delivery. induction of labor has been shown to reduce the rates of those complications, however the optimal time interval has not yet been determined. the main purpose of this single-center randomized prospective study is to assess the differences between two approaches of managing prom at term-expectant management and induction with a dinoprostone vaginal delivery system.

women with singleton pregnancy in cephalic presentation at term (37-41 6/7 weeks gestational age) will be randomised 4 to 12 hours after prom when a sterile vaginal exam will be completed to assign bishop score. when bishop score at presentation will be ≤5, the study will be presented to the patient. once the patient will be consented and randomized, women will receive dinoprostone vaginal delivery system (for up to 24 hours after randomisation) or will be managed expectantly (for up to 24 hours after randomisation). patients randomized to the expectant management group will be admitted to the maternity ward, where they will wait up to a maximum of 24 hours for labor to start spontaneously. patients in the induction group will also be admitted to the maternity ward and induced with a dinoprostone vaginal delivery system. if not removed sooner, the vaginal delivery system will be removed after 24h. if patients in both groups will not be in active labor 24 hours after randomisation they will be admitted to the delivery room and health care providers will manage active labor per usual practice. the need for cesarean section or operative delivery or will be at the discretion of the healthcare provider. in the days following birth, woman in both groups, will be asked to fill in a questionnaire about their satisfaction with the labour experience.

Eligibility criteria:
inclusion criteria: * 4 to12 hours after prelabour rupture of membranes * 18-50 years of age * parity 0 to 2 * singleton pregnancy * cephalic presentation * term (37-41 6/7 weeks gestational age) * bishop score ≤5 * reassuring fetal status exclusion criteria: * uterine contractions * signs of infection * signs of non-reassuring fetal status * meconium-stained amniotic fluid * group b streptococcus colonization * fetal demise or major congenital anomaly * intrauterine growth restriction (estimated fetal weight ≤ 3 percentile) * contraindications for vaginal birth or use of prostaglandins for labor induction

Keywords: induction of labour dinoprostone cervical ripening
effects of 5 mg vs. 20 mg desloratadine on skin lesions in patients with chronic urticaria (cu)

Conditions: Chronic Urticaria

Summary: the purpose of this study is to compare urticaria lesions (size, kinetics) by thermography, volumetry and digital time lapse photography in cu patients treated with desloratadine 5 mg or desloratadine 20 mg. hypothesis: updosing of desloratadine (20mg) is more efficient in the treatment of urticarial lesions as compared to standard dosing (5 mg desloratadine).


Eligibility criteria:
inclusion criteria: 1. outpatients with moderate to severe cu for more than 6 weeks. urticaria symptoms must comprise wheal and itch. 2. patients must exhibit spontaneous urticaria lesions in the randomization visit. 3. history of beneficial effects of antihistaminic treatment. 4. age between 18 and 60 years. 5. female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised (for details please see protocol). 6. female patients must be using adequate contraceptive precautions (contraceptive pill, depot, double barrier methods), or they must be postmenopausal, surgically sterilised, or hysterectomised. 7. voluntarily signed written informed consent. exclusion criteria: 1. the presence of permanent severe diseases, especially those affecting the immune system, except cu. 2. the presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of the gastrointestinal tract). 3. history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia. 4. history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy. 5. evidence of severe renal dysfunction 6. evidence of significant hepatic disease (liver enzymes twice the upper reference value). 7. the presence of galactose intolerance, lapp lactase deficiency or glucose galactose malabsorption. 8. history of adverse reactions including hypersensitivity to dl and loratadine. 9. intake of medicaments that could cause qt changes (drugs listed on www.qtdrugs.org). 10. presence of active cancer which requires chemotherapy or radiation therapy. 11. presence of acute urticaria / angioedema including laryngeal edema 12. history or presence of alcohol abuse or drug addiction. 13. participation in any clinical trial within 4 weeks prior to enrolment. 14. intake of oral corticosteroids or other immunosuppressive therapy within 14 days prior to the beginning of the study. 15. use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study. 16. pregnancy or breast-feeding. 17. existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 amg (arzneimittelgesetz).

Keywords: urticaria
a clinical trial of cognitive behavior therapy for depression, stigmatization, excessive worries, and emotional management among women facing partner violence

Conditions: Cognitive Behaviour Therapy

Summary: 1. aim to investigate the effectiveness of cognitive behavior therapy for depression, stigmatization, excessive worries, and emotional management among women facing partner violence 2. to explore the effectiveness of cbt in managing depressive symptoms, stigma, worries, and emotional disturbance among women facing partner violence.

in this randomized control trial, n=180 participants would be enrolled for eligibility assessment from different shelter homes in the cities of punjab after the eligibility assessment and screening 108 participants would be allocated to experimental and waitlist treatment conditions. participants will be allocated through matchable group characteristics. participant's age range would be between 18 to 45 years. each of the group will be comprised of the same number of participants. both groups will be pre-tested and results will be recorded. a cognitive behavior therapy-based treatment plan will be formulated to address depression, stigmatization, excessive worries, and emotional management among women facing partner violence. 8-10 cbt-based therapeutic sessions with 60 minutes will be conducted with the participant in a one-on-one setting.

Eligibility criteria:
inclusion criteria: * women living in the institutions for at least 2 weeks because of partner violence * second eligibility criteria would be women with a minimum of 1 year of marital relationship will be included. * the age range would be 18 -48 years. * women whose scores are above average on the partner violence scale would be included in the study exclusion criteria: * women greater than 48 years and less than 18 years will be excluded. * women with medical and psychiatric comorbidities will be excluded.

Keywords: depression worries stigma emotion cognitive behavior therapy
hydroxyurea adherence for personal best in sickle cell disease (habit): efficacy trial

Conditions: Sickle Cell Disease

Summary: many youth with chronic disease have difficulty taking medication every day and therefore do not receive full benefit from treatment. sickle cell disease (scd) is an inherited blood disease that affects african americans and other underserved communities. hydroxyurea (hu) is the sole fda-approved drug therapy for scd and is highly effective and improves quality of life. the proposed study, a 5-site four-year randomized control trial (rct), builds upon the investigators' recent feasibility study of the same title. overall goals are reducing barriers to hu use and improving adherence for youth 10-18 years through creation of a daily medication habit. the goal of the proposed multi-site study is to test the efficacy of the habit intervention at 6 months and sustainability of the effect at 12 months.

barriers to medication adherence are common in youth with chronic illness and are a source of racial/ethnic disparities in underserved communities. an inherited blood disease, sickle cell disease (scd) is characterized by chronic and acute illness and reduced quality of life (qol). it affects african americans and other underserved communities. hydroxyurea (hu) is the sole fda-approved drug therapy for scd and is highly effective and improves qol. poor adherence is common among youth and young adults with scd. the importance of poor medication adherence, use of community-based health workers (chws) to bridge the gap between health services and underserved parent-youth dyads affected by scd, the strength of the science, the success of the investigators' multi-ethnic feasibility study, and the potential application of study findings to youth with other serious chronic illnesses speak to the importance of this trial.

Eligibility criteria:
inclusion criteria - youth: * one of the two most common sickle cell disease variants (hbss or hbs-b0 thalassemia) * age 10 through18 years (inclusive) * currently prescribed hydroxyurea (hu) ≥18 months (for identifying historical personal best hbf) * current hu dose is within 5% of dose at personal best hbf * pre-enrollment hbf ≥15% below historical personal best, based on mean of ≥2 hbf assessments over preceding 12 months * youth able to speak/read english or spanish inclusion criteria - parent: * parent/guardian speaks/reads english or spanish * parent/ legal guardian willing to participate * family expects to reside in community for ≥ 1.5 years exclusion criteria - youth: * youth not prescribed hu * \<2 hbf assessments over past 12 months * transfusion within 3 months preceding enrollment * final screen hbf (visit 0) of ≤15% decrease below personal best hbf * sexually active female 10 years or older and not using reliable contraception (due to hu teratogenic risk) * pregnancy * cognitive impairment (\>2 levels below expected grade) * youth not residing with parent/legal guardian exclusion criteria - parent: * parent/legal guardian does not reside with youth

Keywords: hydroxyurea community health worker (chw) text messages medication adherence
predictors of prognosis in ibd patients

Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Summary: a study of clinical characteristics and potential prognostic factors in inflammatory bowel disease

inflammatory bowel disease (ibd) is a chronic and relapsing inflammatory disease composed of two types: crohn's disease (cd) and ulcerative colitis (uc). it is difficult to cure the ibd completely and patients with clinical or endoscopic remission can worsen again. therefore, predicting the prognosis of patients with ibd is still challenging. endoscopic biopsied samples and blood samples from ibd patients and non-ibd controls have been collected and the expression levels of multiple markers which are associated with disease activity and severity will be assessed. the correlation between expression levels of multiple markers and prognosis will be evaluated.

Eligibility criteria:
inclusion criteria: * control group: patients who do not have colitis, cancer, and advanced polyp (the number of polyps ≥ 3, the size of polyps ≥ 1cm, high-grade adenoma, villous adenoma) * tnf-α inhibitor-naive ibd group: ibd patients who do not have a history of tnf-α inhibitor treatment * tnf-α inhibitor-treated ibd group: ibd patients who are treated with tnf-α inhibitor exclusion criteria: * age under 18 years * patients who were treated with antibiotics or probiotics within the last 3 months

Keywords: inflammatory bowel disease ulcerative colitis crohn's disease