Kornimate/medical-research-clean huggingface dataset:
bioelectrical impedance phase angle in predicting treatment outcome in patients with extensive stage small cell lung cancer receiving first-line chemotherapy

Conditions: Extensive Stage Small Cell Lung Cancer

Summary: this clinical trial studies bioelectrical impedance phase angle in predicting treatment outcome in patients with extensive stage small cell lung cancer receiving first-line chemotherapy. diagnostic procedures, such as bioelectrical impedance analysis, may help predict a patient's response to treatment for small cell lung cancer.

primary objectives: i. to evaluate the association between phase angle (pa) measurement and progression-free survival (pfs). secondary objectives: i. to evaluate the association between pa measurement and treatment-related outcomes of treatment response, adverse treatment events, and overall survival (os). ii. to determine the feasibility of obtaining pa measurements at a single time point in patients undergoing evaluation in thoracic oncology clinics. outline: patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. after completion of study treatment, patients are followed up every 2-3 months for two years.

Eligibility criteria:
inclusion criteria: * a primary histopathological and/or cytopathological diagnosis of small cell lung cancer (sclc) * diagnosis of extensive stage disease (extensive stage \[es\]-sclc), with stage established by computed tomography (ct), magnetic resonance imaging (mri), or positron emission tomography (pet) scan * scheduled to receive front-line platinum-based chemotherapy with carboplatin or cisplatin plus etoposide * ability to understand and the willingness to sign an institutional review board (irb)-approved informed consent document exclusion criteria: * no recent chemotherapy or surgery, as defined as in the last 6 months * presence of a pacemaker or defibrillator * patients with major chronic disease known to adversely affect pa, including human immunodeficiency virus (hiv)/acquired immune deficiency syndrome (aids), congestive heart failure, tuberculosis * patients with body mass index (bmi) greater than 34 or less than 16 * any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients * unable or unwilling to follow protocol requirements * pregnant women are excluded from participation due to inability to participate in required chemotherapy regimen
parental education and children's screen time

Conditions: Screen Time

Summary: the study was to investigate the efficacy of a parental educational program on reducing screen use, and improving sleep quality and psychosocial adaptations in children aged 4-6 years.

a total of 129 parent-child dyads were randomly allocated to two groups: experimental group (receiving parental education, n=63), and control group (daily activities, n=66). data were collected before and after intervention. instruments included screen time, children's sleep habits questionnaire, and pediatric symptom checklist-17. a linear mixed model analysis was used to examine the efficacy of education intervention.

Eligibility criteria:
inclusion criteria: * children aged 4\~6 years with screen time of ≥ 2 h/day. exclusion criteria: * cerebral palsy, * mental retardation * psychosis * down's syndrome * chronic disease * hearing impairment.
efficacy of spontaneous laughter in the postoperative treatment of children

Conditions: Pain

Summary: the purpose of this study is to determine the efficacy of laughter therapy in children to improve postoperative, evaluating the intensity of postoperative pain, anxiety and hospital stay.

the therapeutic efficacy of laughter is supported in several research which have shown to have preventive and therapeutic effects that contribute to a better quality of life. in addition, laughter can optimize strategies to increase pain tolerance and combat stress, reducing the negative impact such as increased blood pressure, decreases simultaneously perfusion of organs not needed for the motor function, increased metabolism rates cell with increased serum cortisol and increased risk of infections. nevertheless the upswing in research on these effects, there is still a necessity to have evidence-based medicine as most of the available studies are limited by various problems such as lack of objectivity in the assessment and measurement, distinction between laughter and mood, establishment dosing therapies (frequency and time). the aim of our study is to determine the efficacy of spontaneous laughter in children to improve postoperative pain, anxiety and length of hospital stay. methods: a controlled, randomized, open label trial with an experimental group exposed to the conventional pain treatment with laughter therapy; 2 control group, a group with accompaniment without causing the laughter of children to control the effect of a companion instead of the clown and a conventional treatment group to contrast with experimental group.

Eligibility criteria:
inclusion criteria: * pediatric patients between 6 and 14 * i hospitalized with uncomplicated surgical procedure * minimum period of hospitalization of 48 hours * patients with informed consent letter signed by parents or guardians * in patients older than 10 years, a letter of agreement exclusion criteria: * endocrinopathies carriers, cancer, abnormalities of central nervous system immune disorders patients. * patients treated with both topical and systemic steroids

Keywords: laughter children postoperative pain anxiety cortisol
randomized cross-over trd and cpap for osa

Conditions: Obstructive Sleep Apnea

Summary: the objectives of this study is to compare short-term outcomes of cpap and trd in the treatment of obstructive sleep apnea. study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients. primary outcomes are quality of life, degree of sleepiness, and severity of osa determined by fosq ess, and ahi or rdi, respectively.

the objectives of this study is to compare short-term outcomes of cpap and trd in the treatment of obstructive sleep apnea. study design is a randomized cross-over trial during 3-weeks period of each treatment in 36 patients. primary outcomes are quality of life, degree of sleepiness, and severity of osa determined by fosq ess, and ahi or rdi, respectively. wash-in period 1 week and wash-out periods 1 week are required before start each treatment.

Eligibility criteria:
inclusion criteria: 1. osa patients aged over 18 years old at siriraj hospital 2. apnea-hypopnea index (ahi) 5 - 30 events/ h or ahi \> 30 events/h but lowest oxygen saturation \> 70% 3. positive consented form exclusion criteria: 1. patients with severe periodontal diseases 2. patients with unstable medical problems i.e. poorly controlled cardiovascular diseases, cancers, cerebrovascular diseases, epilepsy, dementia, etc. 3. total sleep time less than 2 hour during previous sleep study 4. patients who could not tolerate the side effects of cpap or trd 5. patients who could not follow-up until finishing the protocol or withdraw themselves from the study for any reasons.
improving substance abuse treatment aftercare adherence and outcome

Conditions: Substance Dependence; Compliance; Treatment Outcome

Summary: although substance abuse treatment continuing care participation is strongly related to positive treatment outcomes, participation rates are low and few interventions have been developed that improve continuing care adherence and outcome.

background: although substance abuse treatment continuing care participation is strongly related to positive treatment outcomes, participation rates are low and few interventions have been developed that improve continuing care adherence and outcome. objectives: the objectives of the study were: 1) to compare the effectiveness of an aftercare intervention consisting of a participation contract, attendance prompts, and attendance reinforcers (cpr) to a standard treatment (stx) on adherence to therapy; and 2) to assess the effects of this intervention on treatment outcome methods: we recruited 150 veterans from the salem vamc�s sarrtp who could participate in aftercare. our population is similar to those in other va�s (97% male, 54% caucasian, 46% minority, 49 years mean age, 44% alcohol dependent only, 56% drug dependent, and 44% with a dual diagnosis). in this randomized clinical trial, treatment adherence and outcome were measured at baseline and 3-, 6- and 12-months after participants entered treatment using interviews, questionnaires, alcohol and drug screens, va medical records, and therapist ratings. the study design is a repeated measures nested cohort design, with an intervention and a standard care group. the primary outcome, abstinence rate, will be analyzed using a logistic regression model in which the parameters of interest are estimated using generalized estimating equations (gee). status: participant recruitment and follow-up interviews were completed in june 2003 and august 2004, respectively. the hsr\&d final report was submitted in april 2005. the main results paper and additional papers will be submitted for publication in 2005.

Eligibility criteria:
inclusion criteria: all graduates of the salem va's sarrtp who: live within a 60 minute drive of the salem vamc, or 1 of our 5 sarrtp outreach clinics; have transportation and a job schedule that allows them to attend outpatient aftercare therapy. exclusion criteria:
encouragement-induced movement therapy in daily life

Conditions: Stroke

Summary: stroke places a major burden on health care and society. it often leads to a hemiparesis. intensive stroke rehabilitation speeds up recovery. in daily practice, the financial and/or human resources to provide this intensive rehabilitation are often lacking. applying modern-day tracking and feedback technology to encourage a self-administered, context specific training is expected to offer significant potential to increase intensity of practice. up until now, there has been no randomized trial examining the effect of such an intervention on daily arm usage. the primary objective of this study is to determine the effect of wearing an activity tracking and multimodal feedback device for six weeks on self-reported daily life use of the paretic arm after stroke, when compared to control group stroke subjects wearing a hardware-wise identical sham device providing no feedback. the secondary aim is to examine compliance to use the device and the quantitative, qualitative and functional improvement of the paretic arm. it is hypothesized that participants in the experimental group show a higher change in self-reported daily life use of the paretic arm when compared to the control group both post intervention and at 6-week follow-up. isear is a multicenter, assessor-blinded randomized controlled trial of 62 subjects beyond the first 3 months poststroke.


Eligibility criteria:
inclusion criteria: * above 18 years of age with unilateral stroke and residual hemiparesis leading to a decrease of arm function after completion of all inpatient rehabilitation (at least 90 days post stroke) * ability to lift arm against gravity (\>30 degrees flexion or abduction) * ability to don/doff the devices on both wrists independently or with assistance of a caregiver * ability to give informed consent as documented by signature exclusion criteria: * major untreated depression * severe cognitive impairment * suffering from comprehensive aphasia * severely impaired sensation (unable to feel a soft touch on the dorsal side of their paretic wrist with closed eyes) * other major comorbidities (e.g., cardiopulmonary disease, renal failure, hepatic dysfunction, orthopedic disorders, etc.) * expected hospitalization during study period * known intolerance to device material * known or suspected non-compliance, drug or alcohol abuse * the investigator, his/her family members, employees, and other dependent persons

Keywords: upper extremity feedback rehabilitation randomized controlled trial
extracorporeal ultrafiltration (uf) vs. usual and customary care for patients with severe heart failure (hf)

Conditions: Heart Failure; CHF

Summary: the purpose of this study is to assess the ability of ultrafiltration to influence the rate of hemodynamic improvement, as measured by the decline in the pulmonary artery occlusion pressure, in patients with nyha class iii/iv heart failure.

this study will be preformed in a specialized heart failure unit at the cleveland clinic foundation (ccf) and will include both the uf-treated group and a control group receiving usual and customary care. patients will be stratified according to renal function at the time of admission. therapies will be guided by specific hemodynamic criteria routinely used at the study institution.

Eligibility criteria:
inclusion criteria: * admitted to heart failure unit (h-22) with nyha class iii/iv hf and pulmonary artery catheter in situ * left ventricular ejection fraction \<40% * mean pulmonary artery occlusion pressure ≥20 mm hg * able to give informed consent exclusion criteria: * currently on renal replacement therapy or determined to need renal replacement therapy at the time of enrollment * estimated glomerular filtration rate (gfr) \<15 ml/min * systolic blood pressure (sbp) \<80 mm hg * acute coronary syndrome * hematocrit \>50% * malignancy other than prostrate or skin * chronic edematous states other than hf, including nephritic syndrome and cirrhosis * chronic inflammatory or infectious condition * pregnancy * previous enrollment in this study * expectation of need for heart transplantation or cardiac assist device within one week * pulmonary failure requiring intubation and mechanical ventilation * known or suspected hypersensitivity to dialysis membranes * severe aortic stenosis or regurgitation * severe mitral stenosis

Keywords: heart failure congestive heart failure chf
arteriovenous fistula pain and cold application

Conditions: Arteriovenous Fistula Pain

Summary: tthis study was designed as a single-group comparative prospective intervention study. the aim of the study was to assess the effectiveness of different pain management interventions during avf cannulation. the effects of pain management methods such as cooling spray, aloe vera gel, and the standard procedure on pain levels, and which intervention was more effective in reducing pain compared to the standard procedure, were investigated. the study included patients over 18 and under 65 years old, undergoing hemodialysis, having an avf, literate, without an aloe vera allergy, and without communication barriers or psychiatric disorders. the main research questions were defined as follows: did different pain management methods (cooling spray, aloe vera gel, and standard procedure) affect pain levels during avf cannulation? which intervention was more effective in reducing pain levels? the primary hypotheses were defined as the application of cooling spray and aloe vera gel would reduce pain levels more than the standard procedure. the researchers compared pain levels after each intervention to determine which one was more effective. three different interventions (cooling spray, aloe vera gel, and standard procedure) were applied to participants in sequence, and pain levels were assessed after each intervention using the visual analog scale (vas). additionally, feedback from participants regarding each intervention was collected.


Eligibility criteria:
inclusion criteria: * over 18 and under 65 years old * literate * have an arteriovenous fistula (avf) * undergoing hemodialysis (hd) treatment at least twice a week * no allergy to aloe vera * no communication barriers and/or psychiatric disorders exclusion criteria: * diagnosed with malignancy * having any sensory problems that prevent the assessment of perception and pain * using any analgesic preparations * having a vascular access other than avf * patients in whom avf cannulation is not successful in a single attempt

Keywords: arteriovenous fistula cold application hemodialysis kidney failure pain
efficacy of fingolimod in de novo patients versus fingolimod in patients previously treated with a first line disease modifying therapy

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: this study assessed the efficacy of fingolimod in patients with short duration relapsing-remitting multiple sclerosis who had not been previously treated with disease-modifying therapies (dmts), versus patients with the same disease duration who had previously received first-line dmts.


Eligibility criteria:
inclusion criteria: * patients diagnosed with multiple sclerosis, according to the 2010 revised mcdonald criteria, with a relapsing-remitting course, and with at least 9 t2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years. * patients who have had at least two relapses in the past two years and an expanded disability status scale score between 0 and 3.5, inclusive. patients * treatment naïve: patients who have never been treated with a disease modifying therapy or * previously treated with a first-line disease modifying therapy exclusion criteria: * patients who have received treatment with: fingolimod at any time (e.g. participation in a fingolimod clinical trial), immunosuppressant drugs such as azathioprine or methotrexate at any time; immunoglobulins in the past 6 months. monoclonal antibodies including natalizumab, cladribine, cyclophosphamide or mitoxantrone, at any time. - other protocol defined inclusion/exclusion criteria may apply

Keywords: multiple sclerosis relapsing remitting multiple sclerosis fingolimod early multiple sclerosis naive patients
a phase 3 clinical study of qlm3004 in delaying myopia in children

Conditions: Myopia

Summary: efficacy and safety study of qlm3004 in myopic children

the study was divided into 2 phases, with stage 1 being the primary efficacy and safety confirmation phase and stage 2 a post-withdrawal observation period. stage 1:to evaluate the safety and efficacy of 3 concentrations of qlm3004 compared to vehicle (placebo)for slowing the progression of myopia in children over a 96-week treatment period. stage 2:subjects will enter period 2 of the study, and period 2 will be a post-withdrawal observation period, which will not serve as a validation basis for the efficacy and safety of qlm3004.

Eligibility criteria:
inclusion criteria: * age 6 to 12 years * myopia -1.00d to -4.00d spherical equivalent (se) in both eyes as measured by cycloplegic autorefraction. * astigmatism ≤1.50 d in both eyes. * anisometropia ≤1.50 d se. * informed consent signed by the subjects and/or their legal representatives exclusion criteria: * suffering from serious systemic diseases * any eye disease that affect vision or refractive error * current or prior history of manifest strabismus, amblyopia, or other ocular pathologic changes * acute inflammatory disease or active infection of the eye in either eye, or a history of chronic ocular inflammation or recurrent episodes of ocular inflammation * best corrected distance visual acuity in both eyes\<4.9 * abnormal intra-ocular pressure (\>21 mmhg or difference between two eyes \>5mmhg) * current or previous form of myopia control, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc. * systemic or topical use of medications within 3 months that interfere with efficacy evaluation (excluding optometry) * allergy or hypersensitivity to atropine, excipients, cyclopentolate or fluorescein sodium * participants for whom the clinical significance of ophthalmologic examination abnormalities indicate that one or both eyes are not suitable candidates for treatment based upon the investigator's medical judgment * participation of the drug clinical trial within three month and the device clinical trial within one month * anticipated long-term use of ocular or systemic oral corticosteroids during the study period * any other condition not suitable for the study per investigator's judgement
proof of concept study of immunoadsorption therapy in patients with idiopathic pulmonary arterial hypertension

Conditions: Idiopathic Pulmonary Arterial Hypertension

Summary: this clinical investigation is a medical device trial to examine the safety and efficacy of therasorb® ig flex adsorber treatment (as an add-on to conventional treatment) used exclusively with the life 18® apheresis system for extracorporeal application for ia therapy (5 treatments) performed over 5 to 8 consecutive days in patients with idiopathic pulmonary arterial hypertension and who functional classification iii.


Eligibility criteria:
inclusion criteria: * able to understand and willing to sign the informed consent form * age \> 18 and \< 80 years at time of informed consent * idiopathic pulmonary arterial hypertension diagnosed by right heart catheter * who functional classification iii * application of conventional ipah therapy, which has been stable for the prior 8 weeks * able to perform a 6-minute-walk test (mwt) * negative pregnancy test (β-hcg) at the start of the trial and appropriate contraception throughout the trial for women with child-bearing potential. exclusion criteria: * pregnancy and/or lactation * pah of any cause other than permitted in the inclusion criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, hiv infection, suspected pulmonary veno-occlusive disease * contraindication for right heart catheterization * any change in disease-targeted therapy within 8 weeks prior to inclusion * walking impairment due to causes other than ipah that would preclude performance of a 6mwt * any patient who has received any investigational medication within 8 weeks prior to the start of this trial or who is scheduled to receive another investigational drug during the course of the trial between visits v1 and v9 * known intolerance to immunoadsorption in general or to one of the excipients (e.g. sheep antibodies or agarose) or other supporting agents * hemoglobin concentration of \< 75% below the lower limit of normal * systolic blood pressure \< 85 mmhg * lack of compliance or other similar reason that, in the judgment of the investigator, precludes satisfactory participation in the trial * concurrent severe or uncontrolled medical disease (i.e. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled generalized viral, bacterial and/ or mycotic infection) which by assessment of the treating investigator could compromise patients safety or participation in the study * drug or alcohol abuse within the last 5 years * hypercoagulability * known severe immunodeficiency (e.g. aids) * severe lung disease: fev1/fvc \< 50%, total capacity \< 60% of normal value * indications that prohibit transient anticoagulation using heparin and/or acd-a-solutions

Keywords: pulmonary hypertension pulmonary arterial hypertension therasorb immunoadsorption