Kornimate/medical-research-clean huggingface dataset:
alfentanil versus sufentanil for pain in children during for tracheal suction

Conditions: Child Comfort; Morphine; Intensive Care Units; Pediatric

Summary: the main objective is to assess the efficacy of alfentanil for pain in children treated by tracheal suction in pediatric intensive care units in france, compared to sufentanyl, the current standard treatment.


Eligibility criteria:
inclusion criteria: * child between 1 month and 15 years of age * affiliation to the french social security system or equivalent * child receiving mechanical ventilation for at least 4 hours and less than 48 hours * ventilation to be provided for at least 8 hours * less than 30 days in pediatric intensive care * child under intravenous sedation * consent of both parents * consent of child when possible exclusion criteria: * curarized child * ketamine treatment * children suffering from facial and/or severe brain traumatism * known hypersensitivity reaction to morphine or intolerance insufficiency to sufentanyl * respiratory * chronic obstructive pulmonary disease * myasthenia * treatment with morphine agonists-antagonists, or combination with maois * renal or liver disorders * preterm birth of more than one month of life (but not at full term by corrected age) * associated treatment or pathology contra-indicating administration of sufentanyl epidural

Keywords: comfort b score bis score
using a wireless controller to deliver a lighting intervention to persons with dementia

Conditions: Alzheimer's Disease

Summary: to test the effect of a tailored lighting intervention controlled by the readings at desk (rad) controller on sleep and mood in alzheimer's disease participants.

each participant will be enrolled for 22 weeks. participants will be randomly assigned to receive either the active or control lighting condition. each lighting condition will be 8 weeks in length. after a 4 week washout, each participant will crossover to the opposite condition. assessments will be performed before and at the end of each lighting intervention.

Eligibility criteria:
inclusion criteria: * diagnosis of alzheimer's disease with a mini mental score examination (mmse) between 0 and 19 * a score \>5 on the psqi. exclusion criteria: - use of sleep medication
study of pf-07220060 with letrozole in adults with hr-positive her2-negative breast cancer who have not received anticancer treatment for advanced/metastatic disease

Conditions: Breast Cancer

Summary: the purpose of this study is to determine the safety and efficacy of pf-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer: * hr-positive (breast cancer cells that need estrogen or progesterone to grow) * her2-negative (cells that have a small amount or none of a protein called her2 on their surface); * locally advanced (that has spread from where it started to nearby tissue or lymph nodes) or metastatic disease (the spread of cancer to other places in the body) * who have not received any prior systemic anti-cancer treatment for advanced/metastatic disease. approximately half of the participants will receive pf-07220060 plus letrozole while the other half of participants will receive the investigator's choice of treatment plus letrozole. the study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.


Eligibility criteria:
inclusion criteria: * histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent. * documented estrogen receptor (er) and/or progesterone receptor (pr)-positive tumor * documented her2-negative tumor * previously untreated with any systemic anticancer therapy for their locally advanced or metastatic disease. * measurable disease or non-measurable bone only disease as defined by recist version 1.1 exclusion criteria: * in visceral crisis at risk of immediately life-threatening complications in the short term. * current or past history of central nervous system metastases. * have received prior (neo)adjuvant endocrine therapy (et) and had recurrence during or within 12 months after the last dose of et. * have received prior (neo)adjuvant cdk4/6i and had recurrence during or within 12 months after the last dose of cdk4/6i. * inadequate renal function, hepatic dysfunction, or hematologic abnormalities.

Keywords: locally advanced or metastatic breast cancer estrogen receptor positive [er(+)] progesterone receptor positive [pr(+)] hormone receptor positive [hr(+)] human epidermal growth factor receptor 2 negative [her2(-)] er(+)/her2(-) pr(+)/her2(-) hr(+)/her2(-) advanced breast cancer breast tumor breast cancer palbociclib abemaciclib ribociclib partial response+ (pr+) metastatic breast cancer hormone therapy hormone positive breast cancer recurrent breast cancer hr+ her2-negative relapse recurrent first line treatment left sided breast cancer left-sided breast cancer right sided breast cancer right-sided breast cancer unilateral breast cancer cancer of the breast cdk4i cdk4/6i bilateral breast cancer
a study evaluating 10 mg and 25 mg doses of etanercept in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (ra). the two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

this study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (ra). the two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

Eligibility criteria:
inclusion criteria: * presence of \>6 swollen joints and \>6 tender joints * inadequate response to at least one disease modifying anti-rheumatic drug (dmard) * have not been treated with a dmard for at least 4 weeks prior to the baseline visit exclusion criteria: * previous treatment with etanercept, antibody to tnfα, or other tnfα inhibitors * received investigational drugs within 6 months of the baseline visit * received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit

Keywords: rheumatoid arthritis
predicting response to capecitabine in women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: identifying genes that increase a person's susceptibility to side effects caused by capecitabine may help doctors plan better treatment. purpose: this clinical trial is studying blood samples in predicting response to capecitabine in women with metastatic breast cancer.

objectives: primary * to determine the sensitivity, specificity, and positive and negative predictive values of dihydrouracil/uracil (uh_2/u) ratio measured before starting treatment on grade 3-4 capecitabine-related toxicity in women with metastatic breast cancer. secondary * to prospectively test the value of the germinal genotype of thymidylate synthase (ts) and methylenetetrahydrofolate reductase (mthfr) as predictors of resistance to capecitabine. * to evaluate the practical feasibility of such pre-therapeutic screening. * to determine the sensitivity, specificity, and positive and negative predictive values of dihydropyrimidine dehydrogenase genotyping on grade 3-4 capecitabine-related toxicity in the first and second courses. * to evaluate the predictive gain provided by genotyping relative to phenotyping alone. * to evaluate the influence of ts and mthfr gene polymorphisms on clinical response and duration of response. * to evaluate the pharmacokinetics of capecitabine and its metabolites and their relationship with uh_2/u and genotype. * to evaluate the total cost of pre-therapeutic phenotyping alone and the combination of phenotyping and genotyping. * to exhaustively analyze the 23 exons of the dihydropyrimidine dehydrogenase (dpyd) gene in patients who developed toxicity. outline: this is a multicenter study. patients receive oral capecitabine twice daily on days 1-14. treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. blood samples are collected 8-15 days before the start of treatment and periodically on the first day of treatment for dihydropyrimidine dehydrogenase phenotyping (dihydrouracil/uracil ratio and high performance liquid chromatography analysis), genotyping (4 most relevant single nucleotide polymorphisms), and pharmacokinetic analysis.

Eligibility criteria:
disease characteristics: * radiologically (by scintography) or histologically confirmed metastatic breast cancer * at least 1 measurable or evaluable target lesion * receiving capecitabine as monotherapy or with targeted antiangiogenic therapies (e.g., bevacizumab or trastuzumab) * no uncontrolled brain metastases * hormone receptor status not specified patient characteristics: * menopausal status not specified * life expectancy ≥ 3 months * fertile patients must use effective contraception * no chronic uncontrolled illness * no congestive heart failure * no peripheral venous disease * no severe uncontrolled infection * no hypoxemic respiratory failure * no prior primary cancer except for basal cell carcinoma of the skin * no psychologic disorder prior concurrent therapy: * see disease characteristics * no capecitabine co-administered with chemotherapy

Keywords: stage iv breast cancer
activity level and barriers to participate of cardiac rehabilitation in advanced heart failure patients

Conditions: Heart Failure，Congestive; Cardiac Rehabilitation; Physical Exercise

Summary: a prospective longitudinal and observational clinical study will be conducted with hospitalized heart failure patients.the main purpose is to know the level of physical activity of these patients after their discharge in relation to the orientation received during their hospitalization and identify the barriers perceived by these patients to participate in a cardiac rehabilitation program. the outcomes are available by telephone calls in 30 and 90 days after discharge.

heart failure is a progression epidemic problem, parallel to population aging. the costs of this disease are estimates in 38 billion of dollars per year, many of those have a relationship to high number of hospitalizations and decompensated heart failure. non-adherence to drug treatment and non-pharmacological measures as cardiac rehabilitation are the major causes of high number of mortality and hospitalizations by heart failure. our objectives will be to identify in decompensated heart failure inpatients the level of physical activity that they done before hospitalization, the barriers for the non-use of cardiac rehabilitation and their disposition to changes of lifestyle. correlation between level of physical activity and readmission in 30 and 90 days after hospital discharge will be done. to understand the profile of these patients and difficulties for to do physical exercise could help to make future actions with focus in to obtain high adherence to changes in lifestyle.

Eligibility criteria:
inclusion criteria patients in the heart failure protocol of the cardiology program with medical release in the next 72 hours exclusion criteria * inpatients for more than 30 days * younger than 18 years old * patients not recommended to do exercises (patients with osteoarticular alterations that doesn't allow the performance of physical exercise) * patients with cognitive impairment (mini mental \<24), visual or psychiatric impairment which restrain the comprehension of the questionnaires
nefopam as a multimodal analgesia for thoracic surgery

Conditions: Lung Cancer

Summary: acute postoperative pain after video-assisted thoracoscopic surgery is very severe. because pain after thoracic surgery prevents early recovery, and increases postoperative complications, its is important to prevent pain after video-assisted thoracoscopic surgery. in the present study, we will evaluate whether nefopam reduces pain after video-assisted thoracoscopic surgery.


Eligibility criteria:
inclusion criteria: * patient scheduled for elective video-assisted thoracoscopic surgery * american society of anesthesiologists physical grade i, ii, iii * patient aged from 18 years old exclusion criteria: * history of allergy in nonsteroidal anti-inflammatory drugs, or nefopam * renal insufficiency * liver insufficiency * myocardial infarction * glaucoma * pregnant and lactating women at the time of surgery * patient who did not consent to the use of patient-controlled analgesia
neuromuscular training improves single-limb stability

Conditions: ACL Injury

Summary: pretest/post-test study design, study will try to determine if a 6-week neuromuscular training program designed to decrease the incidence of anterior cruciate ligament (acl) injuries would improve single-limb stability in young female athletes. healthy female high school athletes will participate in this study. single-limb postural stability for both lower extremities will be assessed with stork balance test, star excursion balance test for dynamic balance and single leg stance test for static balance. participants will be included through convenient sampling. informed consent will be taken from all the participants.

in this controlled single-group pretest/post-test study design, study will try to determine if a 6-week neuromuscular training program designed to decrease the incidence of anterior cruciate ligament (acl) injuries would improve single-limb stability in young female athletes. current study hypothesized that neuromuscular training would result in an improvement of postural stability, with the greatest improvement taking place in the medial-lateral direction. healthy female high school athletes will participate in this study. single-limb postural stability for both lower extremities will be assessed with stork balance test, star excursion balance test for dynamic balance and single leg stance test for static balance. participants will be included through convenient sampling. informed consent will be taken from all the participants. those individuals who will match the inclusion and exclusion criteria will be a part of the study. the neuromuscular training program will consist of three 90-minute training sessions per week for 6 weeks. following the completion of the training program, each subject will be re-evaluated to determine change in total, anterior-posterior, and medial-lateral single-limb stability.

Eligibility criteria:
inclusion criteria: * age will range from 13-20 * female participants * individuals with postural instability and impaired balance will be included. exclusion criteria: * any malignancy * infection * systemic illness * trauma

Keywords: single limb stability neuromuscular training female athletes acl
prevalence of antiphospholipid antibodies among women with preeclampsia

Conditions: Preeclampsia

Summary: the purpose of this study is to determine the prevalence of positive antiphospholipid antibodies among women with preeclampsia and to determine the effect of antiphospholipid antibodies on the severity of preeclampsia and the obstetric outcomes

for all women included in the study, blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant. the clinical details of all women will be collected by reviewing their hospital and prenatal records. the following clinical characteristics will be evaluated: maternal age, previous gestations, parity, past or family history of preeclampsia, gestational age at the onset of preeclampsia, gestational age at delivery and birth weight. the following pregnancy and delivery complications will be assessed: placental insufficiency, intrauterine growth restriction, fetal loss (stillbirth) and early neonatal death.

Eligibility criteria:
inclusion criteria: * pregnant women with preeclampsia. exclusion criteria: * women with systemic autoimmune disease. * women with active thromboembolic disorders. * women with history of previous thromboembolic disorders.

Keywords: preeclampsia antiphospholipid antibodies
glaucoma adherence study

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Summary: the purpose of this study is evaluate adherence to duotrav® when reinforced by the use of the travalert™ dosing aid.

this study was conducted in france, uk, italy, and netherlands. an identical study was conducted in spain under protocol id emd-07-02. a combined enrollment number is presented.

Eligibility criteria:
inclusion: * provide informed consent. * able to follow instructions and be willing and able to attend required study visits. * able to read and complete study questionnaires. * clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye. * intraocular pressure considered safe, in both eyes, assuring clinical stability of vision and the optic nerve throughout the trial. * currently treated with duotrav alone, dosed in the evening for at least for 30 days, at visit 1. * best corrected visual acuity of 20/200 snellen or better in each eye. * intraocular pressure ≤ 30 mm hg in both eyes. * evidence causing the investigator to consider the patient to be non-adherent, at some level, to their glaucoma medication. * agree that their adherence could be improved by the intervention with the dosing aid described in this study. * other protocol-defined inclusion criteria may apply. exclusion: * presence of other primary or secondary glaucoma not listed in inclusion criterion. * any abnormality preventing reliable applanation tonometry in the study eye(s). * any known opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of the study eye(s). * concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. * intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to visit 1. * risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment. * progressive retinal or optic nerve disease from any cause. * women of childbearing potential not using reliable means of birth control. * women who are pregnant or lactating. * a condition, which in the opinion of the principal investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient. * participation in any other investigational study within 30 days prior to visit 1. * known medical history of allergy, sensitivity or poor tolerance to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the principal investigator. * unwillingness to risk the possibility of darkened irides, eyelash changes or periocular pigmentation. * history of, or at risk for uveitis or cystoid macular edema (cme). * any physical disability which prevents the accurate use of the travalert™ dosing aid. * unable to accurately instill the travoprost/timolol fixed combination in the evening. * other protocol-defined exclusion criteria may apply.

Keywords: adherence compliance glaucoma ocular hypertension
clinical and laboratory profile of myasthenia gravis in children at sohag university hospitals

Conditions: Myasthenia Gravis in Children

Summary: this study includes clinical and laboratory studies of patients with myathenia gravis at sohag neurology outpatient clinic of pediatric department

all patients in this study were subjected to the followings: (a) clinical history focusing on: sociodemographic data: age, gender , residence,and degree of consanguinity. full neurodevelopmental history: neurological evaluation family history. mode of delivery (b) thorough clinical examination: general examination including general look, vital signs and anthropometric measurements. scale system include gross motor function and muscle power(quantitative myasthenia gravis scale) \[36\] detailed neurological examination including motor ,sensory and reflexes. (c) investigations: 1. electrophysiological testing: emg : is especially useful in diagnosis of seronegative mg and congenital myasthenic syndromes. ncs: including repetitive nerve stimulation test (r nst) 2. laboratory studies: serology. detection of antibodies to the achr supports the diagnosis of jmg. in young children where achr antibodies are negative this can lead to difficulty in differentiating from cms. thyroid function tests : 3. imaging: ct chest: although thymoma in children is rare, the thymus must be imaged once jmg has been diagnosed. 4. molecular studies (when possible).

Eligibility criteria:
inclusion criteria: * all patients from 1 month to 16 years confirmed diagnosis of myasthenia gravis by neurological and laboratory data. care giver accept to participate in the study. exclusion criteria: * failure to obtain informed consent. other neurological and neuromuscular disorders. age above 16 years.
effect of bibw 2948 bs in copd

Conditions: Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic

Summary: study of bibw 2948 bs in patients with copd and chronic bronchitis


Eligibility criteria:
inclusion criteria: * copd smokers * ages between 40 and 70 exclusion criteria: * significant other diseases * abnormal hematology * abnormal liver function * psychiatric disorders * pulmonary obstruction * asthma, allergic rhinitis * dependance on oxygen * patients with history of myocardial infarction * patients with history of cancer * women of child bearing potential * antiplatelet or anticoagulation therapy
real life of aflibercept in france: observationnal study in wet amd

Conditions: Wet Macular Degeneration

Summary: the purpose of this study is to collect real-life data on patients with wet age related macular degeneration (amd) for whom treatment with eylea was initiated

the study is both retrospective and prospective to collect local real life data on patients under routine treatment. the observation period starts on january 2014. patients who have received the 1st injection with eylea from january 2014 will be enrolled. patients will be followed up for a period of 48 months or until it is no longer possible

Eligibility criteria:
inclusion criteria: * patient with a diagnosis of wet amd will be enrolled after the decision for treatment with aflibercept (eylea) has been made * patient with 1st injection of eylea from 01 january 2014 until 30 april 2015 will be enrolled * prior/current treatment with any anti-vegf intravitreal injections or macular laser (laser and/or visudyne/pdt) in the fellow eye is allowed * man or woman aged 18 years or more * patient who has been given appropriate information about the study objectives and procedures and who has given his/her written, informed consent; exclusion criteria: * patient with another retinal disease: diabetic retinopathy, diabetic macular oedema (dme), myopic choroidal neovascularization, retinal vein occlusion (rvo), central serous chorioretinopathy (csc), angioid streaks * patient who does not meet the local indication criteria for eylea treatment.contraindications listed in the summary of product characteristics (smpc) must be taken into account * patient who has previously been treated with any macular laser (laser and/or visudyne/pdt) or any anti-vegf intravitreal injections for the study eye * patient taking part in an interventional study at the time of enrolment.

Keywords: wet age-related macular degeneration (wet-amd) naïve patients real life aflibercept