Kornimate/medical-research-clean huggingface dataset:
co'moon for supporting breast cancer patients on adjuvant endocrine therapy

Conditions: Breast Cancer; Quality of Life; Self Efficacy

Summary: the objective of the study is to evaluate the effect of an online tool, based on patient reported outcomes (co'moon), on the quality of life of breast cancer patients on adjuvant endocrine therapy in the university hospital leuven.

the project aims to develop and evaluate an online programme to support patients with breast cancer on adjuvant endocrine therapy in the university hospital leuven. the tool "co'moon" has been developed in the first phase of the project and secondly refine in a pilot study. in the third phase a randomised controlled study investigates the effect of co'moon in comparison with the standard of care in the university hospital leuven. hereby focussing on the improvement of self-efficacy en quality of life.

Eligibility criteria:
inclusion criteria patients: * women * older than 18 years * speaking, understanding and writing dutch fluently * mentally competent * recently underwent a operation for breast cancer (invasive or in situ) * takes aet for maximum two months * consultation planned within 4-5 month * home access of a computer with internet connection exclusion criteria patients: * different treatments regimes (e.g. adjuvant trial or a combination with cycline-dependent kinase (cdk) 4/6-inhibitors) * metastatic disease inclusion criteria health care professionals: * contact with patient(s) included in the trial exclusion criteria health care professionals: * included in panels * member of the research team
evaluation of office-based sheathed flexible nasopharyngoscopy

Conditions: Otorhinolaryngologic Diseases

Summary: the processing of standard flexible nasopharyngoscopes is a time-consuming and costly process. the goal of this study is to determine the efficiency and cost-effectiveness of sheathed flexible endoscope in an office setting.

methods: randomized, single-blinded, controlled trial setting: office practice of two academic otolaryngologists at a community hospital. primary outcomes: patient pain and discomfort, optical quality secondary outcomes: physician and nursing staff satisfaction cost-analysis comparison: no-sheath flexible nasopharyngoscopy versus sheathed flexible nasopharyngoscopy

Eligibility criteria:
inclusion criteria: * adult patients presenting to the otolaryngology-head and neck surgery service with complaints warranting flexible endoscopy exclusion criteria: * known sinonasal masses or nasal polyposis * unable to complete vas surveys * significant septal deviation * unable to tolerate in-office flexible nasopharyngoscopy * patients who refuse consent

Keywords: sheath flexible endoscopy otolaryngology office
20% albumin vs. balanced salt solution as resuscitation fluid in cirrhosis with sepsis induced hypotension

Conditions: Cirrhosis, Liver; Acute-On-Chronic Liver Failure; Shock, Septic; Shock Hypovolemic

Summary: patients with cirrhosis patients have a high incidence of sepsis which can trigger decompensation and may result in prolonged hospital stay and increased mortality. about 30%-50% admissions of patients with cirrhosis have sepsis at presentation and about 15% patients admitted to hospital develop sepsis during the hospital stay . after infection develops, the patient may develop acute kidney injury (aki), shock, encephalopathy or disseminated intravascular coagulation (dic) further decreasing the chances of survival. in fact, sepsis in patients with cirrhosis is associated with 15% in-hospital mortality, approximately double that of patients without sepsis. so, sepsis is directly responsible for 30-50% of deaths in cirrhosis . therefore, it is critical to manage sepsis early and appropriately in cirrhosis to reduce the complications and mortality. early administration of fluids, source control and empirical antibiotics along with vasopressors if refractory shock are essential components of treatment in all patients with sepsis. currently, the most accepted strategy for early sepsis management is a combination of early goal directed therapy (egdt) and physiological parameters, such as urine output, lactate clearance, and administration of antibiotics, within 1 hour of presentation . the use of central venous pressure assessment is fallacious for gauging adequacy of fluid resuscitation in cirrhosis, and the difficulty of performing echocardiographic assessments in the setting of ascites and cirrhotic cardiomyopathy is also well described .


Eligibility criteria:
inclusion criteria: * clinical/imaging or biopsy proven liver cirrhosis of any etiology who consent for enrolment. * hypotension (mean arterial pressure \<65mmhg or systolic blood pressure \<90mmhg) * aged between18-65 yrs exclusion criteria: * already received colloid or more than 2 litres of fluid without baseline echocardiographic assessment. * already on vasopressors/inotropes * severe pre-existing cardiopulmonary disease * acute respiratory distress syndrome (ards) * active bleeding like variceal bleed * cerebrovascular events * chronic renal disease - end stage renal disease (esrd)/ patient on renal replacement therapy * admission to icu following liver transplantation, burns, cardiac surgery * brain death or likely brain death within 24 hours * previous adverse reaction to human albumin solution * pregnant or lactating women * informed consent refused by patient or attendants
quadratus lumborum block for abdominoplasty

Conditions: Pain, Postoperative; Abdominoplasty

Summary: double blinded, randomized, controlled, phase iv intervention trial. both groups will receive a quadratus lumborum block (ql), using ropivacaine 3.75 mg/ml in the intervention group, and sterile sodium chloride in the control group. the aim of study is to investigate the effect of a ql block on the perioperative pain during postbariatric abdominoplasty.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical classification status (asa) i-ii * age 18 to 64 * weight above or equal to 60 kg * scheduled for post-bariatric surgery with standard full abdominoplasty performed by dr frøyen * patient is expected able to cooperate during the treatment and follow up. * signed informed consent obtained and documented according to the international conference on harmonization (ich) good clinical practice (gcp), and national/local regulations. exclusion criteria: * a history of anaphylactic shock * cardiovascular disease other than hypertension and/or hyperlipidemia * known allergy to ropivacaine or morphine * a history of chronic pain * psychiatric comorbidity * scheduled opioid pain medication or neuroleptic drugs * coagulation disorders or treatment with platelet inhibitors * pregnancy or breastfeeding * treatment with class iii antiarrhythmics, sertindole, ziprasidone, amisulpride, ceritinib, hydroxyzine, fluvoxamine * any medical contraindication to the study intervention by the attending anaesthetist or surgeon (to be specified in screening form).
study of the characteristics of chronic pain in patients with addiction

Conditions: Chronic Pain; Addiction

Summary: it is described in the literature a higher prevalence of pain in patients with an addiction but there are few studies describing the pain profile of patients with use disorder. pain has a very negative impact on the quality of life of opioid substituted patients. improving knowledge on this point would make it possible to better guide specific care. the investigator proposes to conduct a single-center descriptive observational study using questionnaires, without changing the management of patients with chronic pain. the primary objective of the study is to determine the prevalence of chronic pain in patients with substance addiction hospitalized for addiction treatment.

it is described in the literature a higher prevalence of pain in patients with an addiction but there are few studies describing the pain profile of patients with use disorder. pain has a very negative impact on the quality of life of opioid substituted patients. improving knowledge on this point would make it possible to better guide specific care. the investigator proposes to conduct a single-center descriptive observational study using questionnaires, without changing the management of patients with chronic pain. all patients admitted to hospitalization in the addiction department of the lorient hospital will be offered participation in the study. the primary objective of the study is to determine the prevalence of chronic pain in patients with substance addiction hospitalized for addiction treatment. the study will also evaluate the impact on daily activities of the presence of two chronic pathologies: chronic pain and addiction, describe the frequency of the two main psychiatric comorbidities of chronic pain: anxiety and depression, describe the different components of chronic pain in patients with substance addiction, and get information on analgesic medications.

Eligibility criteria:
inclusion criteria: * \> 18 years old * presence of addiction to at least one substance, based on dsm-5 criteria * hospitalized in the addiction service of lorient hospital * knowing how to read and write french * not objecting to their participation in the study after informed information exclusion criteria: * already included during a precedent hospitalization * adults subject to legal protection or deprived of their liberty.
finding patterns in clinical trial experiences of patients with eczema

Conditions: Eczema

Summary: historically, participation in clinical trials has been skewed towards certain groups. however, research on the factors that influence participation, both positive and negative, is limited. eczema clinical trial patients help us identify these factors by sharing trial experiences during the course of the observational medical study. this study will include a diverse group of participants to gather a wide range of information on clinical trial experiences. the collected data will then be used to benefit future eczema patients who are considering participating in a clinical study.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with eczema * patient is 18 years old * patient has self-identified as planning to enroll in an observational clinical study exclusion criteria: * patient does not understand, sign, and return consent form * patient is pregnant * inability to perform regular electronic reporting

Keywords: eczema
ossiview normative mobility data collection protocol

Conditions: Conductive Hearing Loss, Middle Ear

Summary: the goal of this observational study is to learn about the sound-induced vibration level of certain structures in the middle ear in the normal-hearing population. the targeted structures are part of a chain of structures responsible for conducting sound within the auditory system and so their ability to vibrate normally in response to sound is relevant to the diagnosis of conductive hearing loss. the main questions the study aims to answer are: * what are the mean and variance of the normal sound-induced vibration level at two anatomical locations, the umbo of the malleus and the tip of the incus? * are there any significant differences in these vibrational responses associated with sex or age? participants will have their ossicular mobility measured with an investigational medical device that sends light into the middle ear and measures the motion-induced phase shift on light reflected from the target structures when a sound stimulus is presented. standard hearing tests including audiometry and tympanometry will also be performed to confirm the normal hearing status of participants.


Eligibility criteria:
inclusion criteria: * normal-hearing * over the age of 18 * at least one of incus or umbo visible under otoscopic examination * type a 226hz tympanogram with peak static compliance occurring at pressure between -99mmh20 and +50mmh20 and peak static compliance in the range from 0.3 to 1.6 cc exclusion criteria: * audiometric air conduction thresholds greater than 40 dbhl at 500 hz, 750 hz, 1000 hz, 1500hz, 2000 hz, 3000 hz * audiometric air bone gap greater than 5db at 500hz, 750hz, 1000hz, 1500hz, 2000hz and 3000hz * self-reported history of ear infection in the previous 3 months * self-reported history of middle ear surgery in the last 5 years * self-reported history of tympanic membrane perforation within the last 5 years * self-reported medical treatment for any ear-related disorder within the last 5 years * evidence of perforation, tympanosclerosis, otitis externa, thickened or fibrotic eardrum, mycosis, fluid, infection or other ear abnormality under otoscopy

Keywords: optical coherence tomography
apatinib plus docetaxel as 2nd line treatment in patients with advanced non-squamous and non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this phase ii, open-label, single arm, exploratory study is to evaluate the efficacy and the safety of apatinib（500mg/d）with docetaxel (60 mg/m²) in advanced non-squamous non-small cell lung cancer after failure of first line chemotherapy.


Eligibility criteria:
inclusion criteria: * ≥ 18 and ≤ 75 years of age * histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer. * egfr mutation testing negative of sensitive mutations * at least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral ct scan) * have failed for 1 lines of chemotherapy * ecog performance scale 0 - 1. * life expectancy of more than 3 months. * duration from the last therapy is more than 6 weeks for nitroso or mitomycin * more than 4 weeks after operation or radiotherapy * more than 4 weeks for cytotoxic agents * adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/l, platelets ≥ 80×10\^9/l, neutrophils ≥ 1.5×10\^9/l, total bilirubin within 1.25×the upper limit of normal(uln), and serum transaminase≤2.5×the uln (if liver metastases, serum transaminase≤5×the uln), serum creatine ≤ 1.5 x uln, creatinine clearance rate ≥ 50ml/min, * signed and dated informed consent.willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure. exclusion criteria: * received more than one kind of chemotherapy regimens * nsclc received other vegfr inhibitors (except beacizumab) or docetaxel chemotherapy * existing therapy related toxicity of prior chemotherapy and/or radiation therapy * intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure * any factors that influence the usage of oral administration * the center of the tumor invaded local large blood vessels * within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ ctcae class 2) or other parts' hemorrhage (≥ ctcae class 3). * within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc. * less than 4 weeks from the last clinical trial
retrospective survey for patients with hypertension and diabetes mellitus

Conditions: Hypertension

Summary: this study will address the treatment rate and control rate of hypertension, treatment pattern and factors to affect blood pressure control by examining (retrospective) medical records of hypertension patients having type 2 diabetes mellitus, among outpatients coming to the endocrinology department in 20 general hospital settings nationwide.


Eligibility criteria:
inclusion criteria: * outpatient type ii dm patients receiving hypertension medication in 2006 * patient with type ii dm receiving hypertension medication during at least 1 year. exclusion criteria: * secondary hypertension patients * patients not receiving hypertension medication

Keywords: hypertension type ii dm jnc7 2007 esh-esc guidelines survey
a phase i study of lxs196 in patients with metastatic uveal melanoma.

Conditions: Uveal Melanoma

Summary: this study was to characterize the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd) and preliminary anti-tumor activity of lxs196 as a single agent and in combination with hdm201 in patients with metastatic uveal melanoma.


Eligibility criteria:
key inclusion criteria: * male or female patients ≥18 years of age * diagnosis of uveal melanoma with histological or cytological confirmed metastatic disease. disease must be treatment naive or have progressed (radiologically or clinically) on most recent therapy. * willingness to provide newly obtained tumor tissue at baseline and on treatment unless contraindicated by medical risk in the opinion of the treating physician. * measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \>10 mm with ct scan. * ecog performance status ≤ 1 key exclusion criteria: * malignant disease other than that being treated in this study. * symptomatic or untreated cns metastases or spinal cord compression. brain metastasis must be stable with verification by imaging . * impaired cardiac function or clinically significant cardiac diseases * history of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism (applicable to combination part only). * patients who are receiving treatment with medications that cannot be discontinued prior to study entry and that are considered to be any of the following: * known and possible risk for qt prolongation * known to be strong inducers or inhibitors of cyp3a4/5 (for single agent part); known to be moderate to strong inducers or inhibitors of cyp3a4/5 (for combination part) * known to be inducers or inhibitors of p-gp * known to be substrates of cyp3a4/5 and p-gp with a narrow therapeutic index * patients with abnormal laboratory values, defined as any of the following: * ast or alt \> 3 times uln, ast or alt \> 5 times uln for patients with liver metastases. * total bilirubin \> 1.5 x uln, except for patients with gilbert's syndrome who are excluded if total bilirubin \> 3.0 x uln or direct bilirubin \> 1.5 x uln. * absolute neutrophil count (anc) ≤ 1.5 x109/l. * platelets ≤ 100 x 109/l. * hemoglobin (hgb) ≤ 90 g/l (9 g/dl). * creatinine \> 1.5 x uln * patients receiving live vaccines due to the expected bone marrow toxicity (applicable to combination part only). * patients treated with growth factors targeting the myeloid lineage (e.g. g-csf, gm-csf and m-csf) within 2 weeks of starting study treatment. (applicable to combination part only).

Keywords: uveal melanoma metastatic uveal melanoma phase i lxs196 pkc inhibitor hdm201 hdm2 inhibitor dose escalation
efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma

Conditions: Asthma

Summary: to provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination qmf149.


Eligibility criteria:
inclusion criteria: * patients with persistent asthma, diagnosed according to gina 2010 guideline and who additionally meet the following criteria: * patients who are receiving ics treatment in a stable regimen for ≥ 4 weeks * patients with a pre-bronchodilator fev1 value of ≥ 40% and ≤ 80% of predicted normal value * patients who demonstrate an increase of \>= 12% and 200 ml in fev1 * acq-5 score ≥ 1.5 exclusion criteria: * patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked). * patients with chronic lung disease, including copd, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis. * patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study. other protocol-defined inclusion/exclusion criteria may apply

Keywords: asthma
effects of second-generation antihistamine bepotastine on cough outcomes in cough patients with allergic rhinitis

Conditions: Allergic Rhinitis; Cough

Summary: this is a phase 4 study to evaluate the the efficacy of second generation antihistamine on cough outcomes in cough patients with allergic rhinitis.

this is a randomized, double blind, placebo controlled trial in which a total of 78 participants who have cough (≥ 3 weeks) and symptoms of allergic rhinitis will be enrolled. study participants will be randomly assigned to either active treatment or placebo group. the subjects in active treatment groups will be treated with daily oral bepotastine for 2 weeks, while those in placebo group will take identical-looking tablets. the efficacy of bepotastine will be assessed at the end of 2-week intervention using leicester cough questionnaire.

Eligibility criteria:
inclusion criteria: 1. had a cough for at least 3 weeks (score of ≥30 mm on the vas) 2. history or allergic rhinitis confirmed with skin prick test or serum specific ige test and current one or more symptoms of allergic rhinitis (runny nose, obstruction, sneezing, nasal itching) 3. provided written informed consent 4. were willing and able to comply with the study protocol exclusion criteria: 1. current smoker or individuals who have smoked within the past 1 month prior to study entry 2. sings of coexisting respiratory diseases requiring active treatment such as fever, chills, wheezing, dyspnea, or purulent sputum 3. currently under allergen immunotherapy 4. 1) allergic rhinitis or chronic rhinosinusitis under treatment with intranasal corticosteroids (ins) or leukotriene receptor antagonist (ltra) or 2) allergic rhinitis requiring treatment with ins or ltra 5. treatment with an angiotensin converting enzyme (ace)-inhibitor within 4 weeks prior to the enrollment 6. forced expiratory volume in 1 second (fev1)/forced vital capacity (fvc) \< 0.7 or fev1 % of predicted \< 80% within 1 month prior to enrollment 7. abnormal findings on chest x-ray related to cough within 1 month prior to enrollment 8. diagnosis or treatment of bronchial asthma or copd within 1 year of the enrollment 9. clinically significant medical conditions possibly affecting evaluation of cough and nasal symptoms 10. history of hypersensitivity or severe adverse reaction to antihistamines 11. unable to fill in the questionnaires (blindness, unable to read) 12. unable to provide informed consent 13. history of taking following medication within 2 weeks of the enrollment; ltra, nasal decongestants, intranasal corticosteroids (ins), systemic corticosteroids, antitussive agents (otcs, codeine)

Keywords: cough, allergic rhinitis, antihistamines