Kornimate/medical-research-clean huggingface dataset:
nexium capsules re maintenance specific clinical experience investigation

Conditions: Repeatedly Recurring Esophagitis; Relapsing Reflux Esophagitis

Summary: the purpose of this study is to collect following data in patients given nexium capsule (nexium) in usual post-marketing use as the maintenance therapy for repeatedly recurring/relapsing reflux oesophagitis.

nexium capsules specific clinical experience investigation for maintenance therapy for repeatedly recurring/relapsing reflux oesophagitis

Eligibility criteria:
inclusion criteria: * patients with repeatedly recurring/relapsing reflux oesophagitis who will be given nexium for the first time as a maintenance therapy. exclusion criteria: * patients having reflux oesophagitis when nexium is started (grade a, grade b, grade c or grade d of los angeles classification (hoshihara's modification) on endoscopy) * patients having previous history of maintenance therapy for repeatedly recurring/ relapsing reflux oesophagitis

Keywords: maintenance therapy, repeatedly recurring, relapsing reflux oesophagitis, nexium
randomized influenza vaccine evaluation of immune response

Conditions: Influenza

Summary: licensed influenza vaccines are manufactured with a variety of technologies. the majority are split, inactivated vaccines derived from egg-adapted, high growth reassortant viruses. two us licensed products do not use egg-adapted viruses: flucelvax (mammalian cell culture) and flublok (recombinant). there is increasing evidence that egg propagation induces virus mutations that impair the immune responses to circulating viruses. however, the impact of egg-propagation on clinical vaccine effectiveness is uncertain, and there is no preferential recommendation for any specific influenza vaccine product or technology. a direct comparison of serologic response to egg based and non-egg based vaccines in adults has not been performed. this randomized trial will compare serologic responses to the egg- and non-egg a(h3n2) vaccine component. the study cohort will be followed for two influenza seasons to evaluate sequential vaccination effects on immune response.


Eligibility criteria:
inclusion criteria: * aged 18-64 years * marshfield clinic patients living in or around marshfield, wisconsin since july 2015 * willing and able to give informed consent and comply with study requirements exclusion criteria: * receipt of 2018-19 influenza vaccine prior to study enrollment * known to be pregnant at the time of enrollment * current participation or plans to participate in another clinical trial involving an experimental agent * presence of a contraindication to influenza vaccination * plans to relocate outside the geographic location in the next two years

Keywords: influenza vaccine adults immune response
efficacy and safety study of oral solithromycin (cem-101) compared to oral moxifloxacin in treatment of patients with community-acquired bacterial pneumonia

Conditions: Community-acquired Bacterial Pneumonia

Summary: this study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

community-acquired bacterial pneumonia (cabp) is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. the widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity against cabp pathogens. solithromycin is a fourth generation macrolide antibiotic with excellent activity against resistant s. pneumoniae and other key typical and atypical bacterial respiratory pathogens. a completed phase 2 study showed comparable efficacy to levofloxacin in adults with cabp.

Eligibility criteria:
inclusion criteria: * male and female patients ≥ 18 years of age * an acute onset of at least 3 of the following signs and symptoms (new or worsening): 1. cough 2. production of purulent sputum 3. shortness of breath (dyspnea) 4. chest pain due to pneumonia * at least 1 of the following: 1. fever 2. hypothermia 3. presence of pulmonary rales and/or evidence of pulmonary consolidation * port risk class ii, iii, or iv * presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study * not received any systemic antibiotics during the prior 7 days exclusion criteria: * ventilator-associated pneumonia * known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease * hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms * presence of known: 1. viral or fungal pneumonia 2. pneumocystis jiroveci pneumonia 3. aspiration pneumonia 4. other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure) 5. primary or metastatic lung cancer 6. cystic fibrosis 7. active or suspected tuberculosis * known hiv or myasthesia gravis

Keywords: pneumonia cabp cap macrolide
plasma soluble urokinase plasminogen activator receptor and behçet's disease .

Conditions: Behçet Disease

Summary: the purpose of the study is to determine whether plasma levels of the soluble urokinase plasminogen activator(supar) can serve as a blood-based biomarker for diagnosis of behçet's disease and its correlation with disease activity.

behçet's disease (bd) is a chronic, systemic vasculitis disease that can be evident in many systems and characterized by recurrent attacks, oral and/or genital aphthous ulcers, skin lesions, and inflammatory ocular findings. it was first described in 1937 by the turkish dermatologist hulusi behçet.\[1-3\] although with an unclear pathogenesis, bd is considered a type of vasculitis triggered by immunological mechanisms. increased levels of pro-inflammatory cytokines are reported in patients with bd. in the afflicted organs, a remarkable infiltration of neutrophils and lymphocytes can be seen.\[4-6\] diagnosis of bd is mainly clinical, on the association of symptoms, but diagnosis/classification criteria may help. various sets of criteria were created for bd diagnosis and the recent one is the international criteria for behçet's disease (icbd) that was created by 27 countries in 2006 and revised in2014.\[7\] there is no standard laboratory marker for the diagnosis and follow-up of bd. certain cytokines and increased serum levels of c-reactive protein (crp) are considered as markers of disease activity.\[8\] soluble urokinase plasminogen activator receptor (supar), a potential new biomarker, is a soluble form of the membrane-bound receptors expressed from and comprising mainly of various immune cells (monocytes, neutrophils, activated t lymphocytes, macrophages, endothelial cells, keratinocytes, smooth muscle cells and even tumor cells. \[9\] numerous studies on various inflammatory diseases, cancer, tuberculosis, central nervous system infections, sepsis, liver fibrosis and inflammatory bowel disease have shown increased systemic levels of supar. in these diseases, supar systemic levels are shown to have a prognostic value in determining disease severity.\[10\]

Eligibility criteria:
inclusion criteria: * age ≥ 18 * patients diagnosed as behçet's disease according to international study group criteria (icbd ) for diagnosis of behçet's exclusion criteria: * age\< 18 years * other autoimmune diseases. * pregnancy. * acute and chronic systemic infection history. * the presence of chronic diseases such as chronic renal failure, liver and cardiac failure. * presence or history of cancer.
chimney trial of parastomal hernia prevention

Conditions: Parastomal Hernia; Rectal Adenocarcinoma; Abdominoperineal Resection

Summary: chimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (pvdf, dynamesh ipst) to controls in a multi center, randomized setting.

the european hernia society recommends the use of prophylactic mesh when permanent colostomy is made. the results of previous trials using keyhole technique are partially unsatisfactory. specifically designed pvdf mesh used in this trial showed promising results in previous small trial. chimney trial is designed to compare the effectiveness and safety of mesh group to controls operated with no preventive mesh in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection or low haartman's procedure for rectal adenocarcinoma.

Eligibility criteria:
inclusion criteria: * 18 years or older * rectal adenocarcinoma with curative intent laparoscopic or robotic assisted abdominoperineal resection or low hartmann´s operation and permanent colostomy * patient has a life expectancy of at least 12 months. * patient must sign informed consent before any study procedures and agrees to attend all study visits exclusion criteria: * abdominoperineal resection or hartmann's operation by laparotomy or conversion to laparotomy * complication requiring laparotomy during post surgery treatment at surgical ward after apr * patient with a comorbid illness or condition that would preclude the use of surgery (asa 4-5). * patients with concurrent or previous malignant tumors within 5 years before study enrollment * patients with t4b tumors which impose a multi-organ resection * rectal malignancy other than adenocarcinoma * patient undergoing emergency procedures * planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections). * metastatic disease with no possibility of curative surgery * pregnant or suspected pregnancy * patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements * active abdominal infection at the time of surgery * previous surgery at the colostomy site * language barrier or other reasons why informed consent is not possible
a study to assess safety of cedirogant and how cedirogant moves through the body in adult participants with mild, moderate and severe hepatic impairment

Conditions: Hepatic Impairment

Summary: the objective of this study is to evaluate the pharmacokinetics and safety of cedirogant following oral administration of multiple doses in adult participants with hepatic impairment and normal hepatic function.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) is ≥ 18.0 to \< 40 kg/m2 * a condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile (except liver function tests for subjects with hepatic impairment), and 12-lead ecg exclusion criteria: * clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ecg, or laboratory tests (except liver function tests for subjects with hepatic impairment) at screening that is assessed as likely to interfere with the objectives of the trial or the safety of the subject. * history or evidence of active tb or latent tb infection * evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of cervix

Keywords: cedirogant
a study of pertuzumab with high-dose trastuzumab for the treatment of human epidermal growth factor receptor 2 (her2)-positive metastatic breast cancer (mbc) with central nervous system (cns) progression post-radiotherapy

Conditions: Metastatic Breast Cancer

Summary: this study will examine the safety and efficacy of pertuzumab in combination with high-dose trastuzumab in adult participants with her2-positive mbc with cns metastases and disease progression in the brain following radiotherapy.


Eligibility criteria:
inclusion criteria: * pathologically confirmed her2-positive mbc * progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery * completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment * stable systemic disease * eastern cooperative oncology group (ecog) performance status of 0 or 1 * lvef at least 50% * adequate hematologic, renal, and hepatic function * life expectancy more than 12 weeks exclusion criteria: * progression of systemic disease at screening * leptomeningeal disease * history of intolerance or hypersensitivity to study drug * use of certain investigational therapies within 21 days prior to enrollment * current anthracycline use * unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use * active infection * pregnant or lactating women * significant history or risk of cardiac disease * symptomatic intrinsic lung disease or lung involvement * history of other malignancy within the last 5 years
ultrasound guided erector spinae plane block versus retrolaminar plane block

Conditions: Post Operative Pain; Analgesia

Summary: retrolaminar block (rlb) and erector spinae plane block (espb) are alternative approaches to paravertebral block (pvb) and are advantageous in that they are easier and safer techniques compared with the traditional pvb. these blocks are considered to be compartment blocks or interfascial plane blocks. in these approaches, local anesthetics are assumed to penetrate the superior costotransverse ligament and reach the paravertebral space, although the needle tip is not advanced into the paravertebral space. the study aim to evaluate and compare the analgesic efficacy of retrolaminar plane block and erector spinae plane block.


Eligibility criteria:
inclusion criteria: 1. age18-60. 2. both genders. 3. hepatobiliary surgery. 4. asa i-iii. exclusion criteria: 1. drug allergy. 2. morbid obesity (bmi \>40 kg/m2). 3. psychiatric disorder. 4. opiod dependence.
intra-arterial chemotherapy for the treatment of intraocular retinoblastoma

Conditions: Retinoblastoma

Summary: the purpose of this study is to show that chemotherapy delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment alternative to conventional systemic chemotherapy, external beam radiation, and surgical removal of the eye.

delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy. administration of the drug directly to the targeted site thus avoids the complications and adverse events associated with toxicity from systemic, rather than local, chemotherapy.

Eligibility criteria:
inclusion criteria: * patients newborn to 18 years old. * patients with intraocular retinoblastoma, unilateral or bilateral, who would be treated either by systemic chemotherapy, ebr, or enucleation would be considered for this study. exclusion criteria: * patients over the age of 18. * patients with small, localized intraocular rb amenable to focal therapy (laser or cryotherapy). * patients with extraocular disease evident on mri (extension into the optic nerve), massive choroidal/uveal invasion (grade iic or iid per aret0332) or disease outside the globe evident on mri or physical examination. * documented hypercoagulable disorders or vasculopathies. * laboratory exclusion criteria: gfr \< 60 ml/min/1.73 m2

Keywords: retinoblastoma intra-arterial chemotherapy angiography
hypotension prediction effect on aki

Conditions: Bladder Cancer

Summary: it is a single-center randomized controlled trial that aims to figure out the effect of the hypotension prediction index (hpi) on the prevention of acute kidney injury (aki) after radical cystectomy. the primary hypothesis is that hpi software guidance prevents postoperative aki by reducing the duration and severity of intraoperative hypotension (ioh).


Eligibility criteria:
inclusion criteria: * age ≧ 19 * patients undergoing radical cystectomy with neobladder reconstruction * patients undergoing radical cystectomy with ileal conduit urinary diversion exclusion criteria: * unable to voluntarily give consent * unable to use both radial arteries due to such reasons: prior surgery on the radial artery, breast cancer history with axillary ln dissection, av fistula for renal replacement therapy, or abnormal allen's test.
immediate loading a histological study

Conditions: Edentulous Alveolar Ridge

Summary: twelve participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. at least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments. one site will be used as a test and one as a control where experimental mini-implants will be installed. reconstructive surgical procedures will be applied at the biopsy sites.

objective: - to evaluate histologically the influence of the functional load on implants, both immediate and delayed. material and methods: 12 participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. at least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments to obtain a high degree of torque to ensure optimum primary stability. at least one site will be used as a test and one as a control where experimental mini-implants will be installed. test sites will be loaded immediately. the control sites will remain unloaded. after 2 months, mini-implants will be recovered as planned for each group. reconstructive surgical procedures will be applied at the biopsy sites, if necessary, using autologous bone or bone substitutes and membranes. standard implants will be installed during the same surgical session and, after 2 months, the planned prosthesis will be performed. patients will be followed for at least 2 years for evaluation and intervention, if necessary. biopsies will be included in resin to obtain wear cuts for histomorphometric analysis. the bone histomorphometry will be evaluated and statistical analysis will be carried out.

Eligibility criteria:
inclusion criteria: * adult participants (≥25 years of age) with the need of at least two implants to replace teeth of the jaw will be included. * natural antagonist teeth have to be present both at test and control sites to guarantee occlusal contacts exclusion criteria: * untreated rampant caries or uncontrolled periodontal disease of the remaining teeth * diabetes not controlled diabetes or any other systemic or local disease that could compromise postoperative healing and / or osseointegration * need for systemic corticosteroids or any other medication that could compromise postoperative healing and / or osseointegration * inability or unwillingness to return to follow-up not likely to be able to comply with the study procedures according to the judgment of the investigators * pregnancy

Keywords: dental implants bone healing clinical trial histology
study to observe the safety and efficacy of etanercept (enbrel®) in patients with moderately active rheumatoid arthritis in every day clinical practice in austria

Conditions: Rheumatoid Arthritis

Summary: this is a prospective non-interventional observational study to evaluate the treatment of moderately active ra patients in every day clinical practice in austria. patients will be observed over 52 weeks. the primary endpoint will be percentage of patients who reach cdai remission after 24 weeks.

non-interventional observational study, national, multicenter prospective non-interventional study (nis) as defined by the austrian drug law § 2a section 3 n/a

Eligibility criteria:
inclusion criteria: 1. the patient is eligible to receive etanercept treatment according to the austrian smpc. 2. the decision to treat the patient with etanercept has been made independently by the physician and is clearly separated from the decision to include the patient in the study. the treatment decision was made in advance and is not dependent on the protocol. 3. the patient was informed about the study and gave his/her consent and signed an independent ethics committee (iec) submitted written informed consent form on use of the data. 4. the patient has moderately active ra, defined as a disease activity of cdai \>10 and ≤22 and/or das28 (crp)\>3.2 and ≤ 5.1 exclusion criteria: 1. any contraindication according to the austrian smpc, which includes: a hypersensitivity to any component of etanercept, active tuberculosis or any other serious infection. 2. patient has previously participated in this study.
evaluation of the psychosocial impact on health professionals exposed during covid 19 coronavirus pandemic

Conditions: Psychological Stress; Psychosocial Impairment; Anxiety; Depression; Post Traumatic Stress Disorder; Coronavirus Infection; COVID

Summary: application of a survey in electronic support to hospital professionals. this survey will include different demographics as well as questions from own elaboration about the different aspects related to the development of work during the health emergency. a third part will be included different validated scales for screening / diagnosis of different problems that can present those who are working in the current situation. the different scales are the phq-9, gad 7, isi, and eie-r. these scales address the different problems that have been seen that can introduce professionals, depression, anxiety, insomnia and adaptation to stressors.


Eligibility criteria:
inclusion criteria: * workers during covid 19 pandemic at hospital de la creu i sant pau exclusion criteria: * no exclusion criteria, only the negative to participate

Keywords: covid 19 healthcare workers mental health