Kornimate/medical-research-clean huggingface dataset:
comparison of the efficacy and tolerability of t1210 and olopatadine hydrochloride 0.1% in the treatment of seasonal allergic conjunctivitis

Conditions: Seasonal Allergic Conjunctivitis

Summary: the aim of this study is to compare the efficacy and the safety of t1210 versus olopatadine eye drops in the topical treatment of seasonal allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * written informed consent * conjunctivitis allergic conjunctivitis exclusion criteria: * severe ocular allergy * vernal keratoconjunctivitis
efficacy study of floseal for prevention of lymphocele after lymphadenectomy for gynecologic cancer

Conditions: Gynecologic Cancer; Cervical Cancer; Endometrial Cancer; Ovarian Cancer; Fallopian Tubal Cancer

Summary: to compare the incidence of lymphocele and lymphatic ascites between patient who use versus who do not use floseal during lymph node dissection


Eligibility criteria:
inclusion criteria: * histologically confirmed primary cancer of the uterine cervix, uterine corpus, ovary, and fallopian tube * figo stage cervical cancer: fiog stage ia2-iia2 uterine cancer: figo stage i-iii ovarian and fallopian tubal cancer: figo stage i-iiib * patients who undergoing surgery including pelvic and/or para-aortic lymph node dissection * patients with adequate bone marrow, renal and hepatic function: wbc \> 3,000 cells/mcl platelets \>100,000/mcl creatinine \<2.0 mg/dl bilirubin \<1.5 x normal and sgot or sgpt \<3 x normal * american society of anesthesiology physical status 0-1 * performance status of ecog 0-2 * patient must be suitable candidates for surgery * patients who have signed an approved informed consent exclusion criteria: * patients with a history of pelvic or abdominal radiotherapy; * patients who are pregnant * patients with contraindications to surgery; * patients who are unfit for surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator); * patient's compliance and geographic proximity that do not allow adequate follow-up. * patients who undergo only lymph node sampling
comparison of virtual reality and podcast in improving patient experience during colposcopy

Conditions: Stress; Anxiety; Pain; Colposcopy

Summary: this study wants to see if two things-virtual reality (vr) and podcasts-can help women feel better during a medical test called colposcopy. the study looks at stress, anxiety, pain, and heartbeat. it also checks if women are happy with the test and how long the test takes. there are three groups: one uses vr, one listens to a podcast, and one gets no extra help. the study will include 75 women in turkey. all women are 25 to 65 years old and need to have a colposcopy. some women cannot join the study-for example, if they are pregnant, cannot see or hear well, or take strong medicine for pain or stress.


Eligibility criteria:
inclusion criteria: * patients scheduled for colposcopy procedure due to suspicion of cervical squamous intraepithelial lesions. * individuals who agree to sign the informed consent form and are willing to participate after being informed about the procedure. * individuals who are deemed suitable for the colposcopy procedure and whose health status does not constitute an obstacle to perform this procedure (no visual or hearing impairment). * volunteers who speak turkish at a level to understand the methods and questionnaires used in the study. exclusion criteria: * those with claustrophobia, epilepsy, or any other neurological or psychological disorder that may cause discomfort when using the vr headset. * individuals with hearing loss that affects their ability to hear podcast content. * individuals with vision loss that affects their ability to see vr content. * individuals who have previously experienced discomfort while using vr or are unable to adapt to vr * individuals who are not suitable for the colposcopy procedure or have a serious health condition that may affect the procedure * individuals who are pregnant. * individuals with language barriers who may have difficulty understanding the study procedures or distractions. * individuals with regular use of sedative or pain medication that may affect stress or pain management during the study.
treatment of asymptomatic fluid overload in peritoneal dialysis patients

Conditions: Chronic Kidney Disease; Peritoneal Dialysis

Summary: introduction peritoneal dialysis (pd) is a life-saving treatment for end-stage renal disease patients. however, cardiovascular disease remains the major cause of morbidity and mortality in pd patients. it is now realized that chronic asymptomatic intravascular hypervolemia is an important cause of cardiovascular disease in pd patients. objectives to determine the effects of treating asymptomatic fluid overload on blood pressure, hospitalization and cardiovascular morbidity in pd patients. hypothesis the investigators hypothesize that treating asymptomatic fluid overload could improve the clinical outcome of pd patients. design \& subjects this is an open label randomized control trial. the investigators plan to recruit 60 pd patients with asymptomatic fluid overload, defined as overhydration (oh) ≥ 2 liters. patients will be randomized to active fluid management (treatment arm) or conventional management (control arm). study instruments overhydration will be identified by bioimpedance spectroscopy. interventions for the treatment arm, active fluid management includes dietary counseling, diuretics, and intensive dialysis regimen. for the control arm, patients will only receive dietary counseling. patients will be followed for one year. main outcome measures blood pressure control, number of hospital admission and duration of hospitalization for all cause, and hospitalization for cardiovascular disease during the study period. data analysis blood pressure control will be compared by student's t test. hospitalization data will be compared by non-parametric mann whitney u test. expected results the study will determine the benefit of treating asymptomatic fluid overload in pd patients.

the investigators plan to recruit 60 pd patients with asymptomatic fluid overload, which is defined as overhydration (oh) ≥ 2 liters as measured by bioimpedance spectroscopy. patients with clinical symptoms of fluid overload (including, but not restricted to, dyspnea on exertion, peripheral edema, pulmonary congestion) will be excluded. the investigators will also exclude patients who are in overt pulmonary edema and required urgent medical care, who have cognitive impairment or problem of communication, unlikely to survive for more than three months, have mechanical problems of the dialysis catheter, or have active peritonitis or peritoneal failure.

Eligibility criteria:
inclusion criteria: * asymptomatic fluid overload, defined as overhydration (oh) ≥ 2 liters as measured by bioimpedance spectroscopy exclusion criteria: * clinical symptoms of fluid overload (including, but not restricted to, dyspnea on exertion, peripheral edema, pulmonary congestion) * overt pulmonary edema and required urgent medical care * cognitive impairment or problem of communication * unlikely to survive for more than three months * mechanical problems of the dialysis catheter * active peritonitis or peritoneal failure

Keywords: cardiovascular disease hypertension
ezetrol post-marketing study

Conditions: Hyperlipidemia

Summary: to compare the lipid lowering efficacy of adding ezetimibe to statin vs. statin alone.


Eligibility criteria:
inclusion criteria: * men or women older than 20 and younger than 80 years of age * willing to follow an ncep therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet for the duration of the study * female patients receiving hormone therapy (including hormone replacement therapy, and estrogen antagonist/agonist, or oral contraceptives) if maintained on a stable dose and regimen for at least 8 weeks prior to visit 1 and if willing to continue the same regimen throughout the study * patient with total cholesterol equal or greater than 240 mg/dl or ldl-c equal or greater than 160 mg/dl for primary (heterozygous familial and non-familial) hypercholesterolemia and/or ldl-c equal or greater than 130 mg/dl for secondary hypercholesterolemia with identifiable risk factors * patient is able to discontinue any lipid lowering drugs for 6-8 weeks wash-out period (6 week for statin and 8 week for fibrate) * triglyceride (tg) concentrations equal or less than 400 mg/dl * liver transaminases (alt, ast) equal or less than 1.5x uln with no active liver disease and equal or less than 1.5x uln at visit 2 exclusion criteria: * women who are pregnant or lactating * history of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy * patients who have been treated with any other investigational drug within 3 months of visit 1 * patients previously randomized to a study with ezetimibe * active liver disease or impaired liver function tests (alt, ast \> 1.5xuln) * impaired renal function ( serum creatinine equal or greater than 1.5 mg/dl or urine protein equal or greater than 100 mg/l) or nephritic syndrome at visit 1 * unstable angina * myocardial infarction, coronary bypass surgery or angioplasty within the previous three months of visit 1 * uncontrolled cardiac arrhythmias * uncontrolled hypertension (treated or untreated) with systolic blood pressure \> 160 mmhg or diastolic \> 100 mmhg at visit 1 * poorly controlled diabetes mellitus patient. (hba1c\>8.0%). if the patient treated with md, no any dm medication will be change during the study period) * uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoprotein, e.g. hyperthyroidism (tsh \> 5.5 (iu/ml). however, patients who are on a stable therapy of thyroid replacement therapy for at least 6 weeks are eligible for enrollment * patients hypersensitive to hmg-coa reductase inhibitors or ezetimibe * patient who is unable to give informed consent (the patient with a legal representative to sign the informed consent is eligible to participate the study.) * any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or confound the results of the study
postoperative pain treatment in total hip arthroplasty: a study to assess the effect of local analgesia

Conditions: Pain, Postoperative

Summary: the purpose of this study is to determine whether the investigator standardized pain treatment plus local pain treatment is more effective than the investigator standardized pain treatment plus placebo in total hip arthroplasty.


Eligibility criteria:
inclusion criteria: * scheduled for an uncemented unilateral total hip replacement because of osteoarthritis * willingness and possibility to follow the instructions of the study * 18 years or older * written informed consent and authority after it has been read and understood. exclusion criteria: * operation with anterior approach or using navigation * do not understand or speech danish * can not use the pain-score numerical rating scale (nrs) * special indications for total hip replacement * anaesthetized in general anaesthesia where a tube is demanded * daily use of strong opioids, based on the investigators assessment * fertile women * asa-score: 3 and 4 * known allergy against the standardized pain treatment, the study drugs and placebo, ropivacaine, ketorolac, adrenalin. * treatment with lithium, dihydroergotamin, full anticoagulant treatment or mao-inhibitor * following illness: * active gastric ulcer or earlier gastrointestinal bleeding, ulceration or perforation of any kind. * suspicions of manifest gastrointestinal bleeding and/or cerebrovascular bleeding * haemorrhagic diathesis * coagulation disorder * severe thrombocytopenia * severe heart insufficiency * severe risk of postoperative bleeding or delayed haemostatic * myocardium hypertrophy or ischaemic heart disease * hypertension * hypovolemics * anhydration * angiooedema * asthma * bronchospasm * severe liver insufficiency * rhinostenosis because of polyostotic * narrow-angled glaucoma * phaeochromocytoma * low plasm-potassium * thyreotoxicosis

Keywords: hip arthroplasty treatment outcome local anesthesia
the validity and reliability of self measurement of upper limb volume

Conditions: Limb Volume Measurement

Summary: lymphedema is a common, chronic, side effect resulting from the treatment of breast cancer.insufficiency in the lymphatic system causes edema in the upper limb. the accepted conservative treatment is based on the anatomy and physiology of the lymphatic system. the aim of the treatment is to reduce the volume of the upper limb by, initial, intensive treatment and then to keep the arm volume at this reduced level.the measurement of limb volume involves measuring the circumference of the arm at defined points and then with the use of a formula the volume of the arm can be calculated. after intensive therapy is complete the responsibility for measuring limb volume moves to the patient. this study will examine the reliability and validity of self measurement of limb volume. the investigators will compare the results of self measurement using the accepted plastic tapemeasure against a paper tape measure adapted for self measurement.both methods will be compared to the "gold standard volume displacement. in the study there will be two meetings with the subjects where the patient and physiotherapist will use the three methods.


Eligibility criteria:
inclusion criteria: * women with arm edema after breast cancer who are being conservatively treated by a physiotherapist. exclusion criteria: * active malignant disease
mobile-based intervention to promote physical activity among the elderly

Conditions: Mobile Health; Physical Activity

Summary: this study aims to explore the feasibility and preliminary effectiveness of a mobile phone-based intervention among elderly individuals with chronic diseases.

promoting physical activity among elderly individuals is an increasingly critical public health priority. regular exercise is essential for maintaining mobility, enhancing mental well-being, and reducing the risk of exacerbating chronic conditions. however, many elderly individuals encounter significant barriers, including physical limitations, lack of motivation, and restricted access to safe environments. this mobile phone-based intervention seeks to address these challenges by offering accessible support through age-appropriate exercise routines, motivational prompts, and educational content delivered directly to participants' mobile devices. the intervention's primary objective is to reduce sedentary behavior, increase physical activity levels, and ultimately enhance the overall health and well-being of elderly individuals with chronic diseases.

Eligibility criteria:
inclusion criteria: 1. age ≥60 years and diagnosed with at least one chronic disease 2. owns a smartphone and is proficient in using wechat 3. daily sedentary time ≥6 hours exclusion criteria: 1. recent surgeries, injuries, or other conditions that would prevent simple physical activity 2. hearing, vision, or physical disabilities
dehydration, rehydration, and blood viscosity

Conditions: Dehydration

Summary: the purpose of this study is to examine and compare the rehydration effect of essentia water, an electrolyzed high-ph bottled water, with industry-standard bottled water purified by reverse osmosis with minerals added, on (1) whole blood viscosity, (2) plasma osmolality, (3) bioelectrical impedance analysis, and (4) body mass change, using serial measurements in apparently healthy adults following exercise-induced dehydration in a controlled environment.


Eligibility criteria:
inclusion criteria: * free from any medication for at least 1 week prior to the study exclusion criteria: * any chronic condition requiring regular treatment or medical follow-up * bleeding disorder or susceptible to prolonged or uncontrolled bleeding * active infection * current smoker * subject has a bmi equal or greater than 30 * use of oral contraceptives in the previous 3 months * subject is pregnant or breast-feeding * currently menstruating

Keywords: exercise hydration dehydration rehydration alkaline water blood viscosity plasma osmolality bioimpedance
extension study of tocilizumab long term treatment of moderate to severe rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: 24 week open-labeled extension study to continue monitoring the same group of patients in the previous mra230tw phase iiib trial in order to evaluate the long term efficacy and safety of tocilizumab.


Eligibility criteria:
inclusion criteria: * patients who had completed at least 5 out of the 7 visits scheduled for weeks 2, 4, 8, 12, 16, 20 and 24 in the tocilizumab phase iiib study(mra230tw). * patients assigned in the phase iiib study(mra230tw), who had received scheduled dose for at least 16 weeks but still failed to achieve adequate treatment response characterized by acr20 exclusion criteria: * patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment. * patients with rheumatoid autoimmune disease other than ra, including but not limited to sle(system lupus erythematosus), or significant systemic involvement secondary to ra. * patients who belong to the class iv of the acr classification criteria for functional status of ra. (acr amended criteria for the classification of functional capacity in rheumatoid arthritis; class iv: largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care). * patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them. * patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(tb),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis b, hepatitis c, or herpes zoster and etc. however, a patient with hand \& foot fungal infections can participate.

Keywords: ra
fbs-asap: fibrobronchoscopy in aspiration pneumonia in the emergency department

Conditions: Aspiration Pneumonia; Bronchoscopy

Summary: non-profit prospective observational pilot study the study will have an overall duration of 3 years, with patient enrollment starting after ethical committee approval. in this study, all patients with a diagnosis of aspiration pneumonia who require aspiration of secretions or ingesta in the emergency department will be considered. a registry will be created with the patients\&#39; data, noting the type of procedure performed: laryngotracheal aspiration with a probe or with fibrobronchoscopy. this observational registry pilot study aims to evaluate the utility and adverse events related to the use of aspiration via videobronchoscopy performed in the emergency department and to compare the clinical outcomes of patients undergoing bronchoscopy with those treated only with blind laryngotracheal aspiration using a probe.


Eligibility criteria:
inclusion criteria: all adult patients who access the emergency department with a diagnosis of aspiration pneumonia and for whom the referring physician determines the need for aspiration of secretions or ingesta. patients must have at least one of the following criteria * radiological evidence of pneumonia (chest x-ray/ct scan/chest ultrasound) * clinical diagnosis of aspiration pneumonia * presence of secretions in the upper airways * respiratory distress in a dysphagic patient * need for oxygen therapy or need to increase fio2 in patients already on home oxygen therapy exclusion criteria: * lack of consent * age \&lt; 18 years * pregnancy * hemorrhagic diathesis * malignant cardiac arrhythmias (vt, av block excluding first-degree av block) * severe airway obstruction

Keywords: aspiration pneumonia bronchoscopy toilette interventional pulmunology respiratory failure pneumonia bacterial pneumonia
biomodel in tetralogy of fallot

Conditions: Tetralogy of Fallot

Summary: using biocardiac model in helping the total correction of the tetralogy of fallot.

using biocardiac model in helping the total correction of the tetralogy of fallot.

Eligibility criteria:
inclusion criteria: tetralogy of fallot

Keywords: biomodel rapid prototyping computed tomograpgy
health coaching for positive airway pressure adherence

Conditions: Sleep Apnea

Summary: this study tested a low-resource, brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of sleep apnea.

we conducted post hoc analysis of a quality improvement initiative in which patients were randomly assigned to receive health coaching or usual care. participants were english- and spanish-speaking patients from a county-based public health system who had previously received a positive airway pressure device for the treatment of sleep apnea. an unlicensed, trained health coach called patients three times to resolve barriers to adherence. adherence measures collected by device modem at baseline and 4 weeks were the primary outcome measures.

Eligibility criteria:
inclusion criteria: * english- or spanish-speaking * at least 18 years of age * had previously received a modem-enabled positive airway pressure device for the treatment of sleep apnea * received care from the san francisco general hospital sleep clinic exclusion criteria: * not english- or spanish-speaking * younger than 18 years * does not have phone number at which could be reached
diet and well-being of young danish children

Conditions: Growth Acceleration; Overweight or Obesity; Biomarkers of Metabolic Syndrome; Programming and Tracking

Summary: the overall objective with the study was to contribute to the scientific basis for dietary and life strategies, policies and dietary guidelines to infants and young children in denmark and with special focus on prevention of obesity and diet related chronic diseases such as type 2 diabetes, ischemic heart disease and osteoporosis.

the skot i study is a prospective cohort study monitoring healthy young children from 9 to 36 months of age. in 2007, 2211 families from copenhagen were randomly selected through the national civil registry and invited to participate in the study by letter. the participants were invited to three examinations at 9 months ±2 weeks, 18 months ±4 weeks and 36 months ±3 months. a total of 330 children are included in the study, where 312 have completed the 9 months examination, 291 completed the 18 months examination and 263 completed the 3-year examination. all examinations took place at department of nutrition, exercise and sports, frederiksberg denmark. the examinations involved collecting a broad spectrum of data. following data were collected: anthropometry (weight, height, age- and sex-specific z-scores for body composition, triceps and subscapularis skinfolds), background interview (concerning e.g. infant feeding, household income, the parent's educational level, allergy and chronic diseases), blood pressure (systolic, diastolic and mean arterial pressure), faeces- and urine sample, blood samples (9 and 36 months), bio impedance analysis (36 months), 7 day diet registration, general questionaire (concerning e.g. sleep, daycare, attendance and use of screen devices), psychomotor questionnaire (motoric development), 7 day physical activity monitoring and dual energy x-ray absorptiometry scan (36 months).

Eligibility criteria:
inclusion criteria: * healthy singletons born at term (week 37-43) between august 2006 and september 2007 with no disease that could influence food intake or growth exclusion criteria: * born preterm (before week 37) * non-danish speaking parents.

Keywords: growth, infancy, children, diet, breastfeeding complementary feeding early life programming tracking physical activity