Kornimate/medical-research-clean huggingface dataset:
trabectedin in treating patients with metastatic pancreatic cancer after first-line chemotherapy

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well trabectedin works in treating patients with metastatic pancreatic cancer after first-line chemotherapy.

objectives: primary * to assess the therapeutic activity of trabectedin, in terms of progression-free survival (pfs) rate at 6 months, in patients with metastatic pancreatic adenocarcinoma progressed after gemcitabine-containing first-line chemotherapy. secondary * to assess the safety profile of this drug. * to assess the response rate and response duration. * to assess the overall survival of these patients. * to assess the pfs rate at 9 and 18 weeks. * to perform blood, plasma, and tumor tissue sampling for biological studies, in order to identify biomarkers predictive for resistance or sensitivity to trabectedin, and to characterize the impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity in translational research studies. outline: patients receive trabectedin iv over 3 hours on day 1. treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. blood samples and tumor tissue are analyzed for identifying biological markers predictive for resistance to treatment and pharmacogenomic and pharmacokinetic profiling on anti-tumor activity in translational research studies. after completion of study treatment, patients are followed up periodically.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the pancreas * metastatic disease progressed after 1 prior gemcitabine-contained chemotherapy * may be given with neoadjuvant, adjuvant, or palliative therapy * measurable disease according to recist criteria * no symptomatic brain metastasis patient characteristics: * karnofsky performance status 60-100% * bone marrow, liver, and kidney function normal * not pregnant or nursing * fertile patients must use effective contraception * no severe comorbidities, including any of the following: * cardiac disease * history of psychiatric disability * no other prior or concurrent malignancy except surgically cured carcinoma in-situ of the cervix, basal cell or squamous cell carcinoma of the skin, and other neoplasms without evidence of disease for ≥ 5 years * no psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule prior concurrent therapy: * see disease characteristics * no prior second-line chemotherapy * no other concurrent chemotherapy or target therapy * no concurrent treatment with other experimental drugs

Keywords: recurrent pancreatic cancer stage iv pancreatic cancer adenocarcinoma of the pancreas
telemedicine in the generals practitioners office

Conditions: Respiratory Distress Syndrome; Pneumonia; Bronchiolitis; Croup; Croup; False; Asthma; Bronchial Hyperreactivity

Summary: pediatrician does physical examination through telemedicine and in real life to see whether the telemedicine consultation corresponds with the real life examination. goal is to determine: 1. check practical feasability 2. check whether there are no great objections for a larger study (ie. in case telemedicine consultation is much more unreliable to do a physical examination a larger study is deemed unsafe)

40 pediatric patients seen by a general practitioner (gp) whom the gp has referred or wants to refer to a pediatrician for clinical evaluation are included in this study. study is designed in 2 parts. part 1 is at the emergency room in the hospital part 2 is at the gps office the pediatrician sees the patient through a telemedicine consultation. then sees the patient in real life to see if what was seen during telemedicine corresponds with the real life consultation. with telemedicine and real life consultation the pediatrician rates the patient as either a candidate to go home or to be admitted. with the telemedicine consultation there is also an option "in doubt: i want to see the patient in real life". also with both telemedicine and real life examination the pediatrician scores the patient using the respiratory observation scale (siew et al, 2016) goal is to: 1. check practical feasability 2. check whether there are no great objections for a larger study (ie. in case telemedicine consultation is much harder to do a physical examination

Eligibility criteria:
inclusion criteria: * pediatric patients with respiratory symptoms whom are referred by a general practitioner to be evaluated by a pediatrician exclusion criteria: * infants younger than 2 months of age * 19 years and older * ex-premature with post-conceptional age \<48 weeks * congenital heart disease * down syndrome * immune deficiency * pre-existent pulmonary disorder (broncho-pulmonary dysplasia, cystic fibrosis) * pre-existent neurological disorders * apnea's * patients with respiratory distress with dehydration symptoms * patients who have already been treated with salbutamol inhalers of nebulizer - emergency patient with respiratory insufficiency * technical problems which cause a delay longer than 10 minutes before a video-connection is made * expected delay before commencing telemedicine consultation of longer than 30 minutes

Keywords: telemedicine respiratory distress pediatric general practitioner
preventing neck & back pain in teleworking office workers: a randomized controlled trial

Conditions: Neck Pain; Low Back Pain; Back Pain

Summary: the purpose of this study is to assess the effect of a general training program and educational session to prevent neck and/or low back pain in desktop workers

after being informed about the study and potential risks, all subjects that met the preset inclusion criteria and gave written informed consent to participate will be randomized into an intervention or control group in a 1:1 ratio. next, subjects of both groups will undergo baseline testing (online survey). the subjects of the intervention group receive a single educational video (online) and are motivated to follow 2 training sessions of 60 minutes each, during 12 consecutive weeks. instructions for the specific exercises are provided via an online platform. the subjects of the control group are instructed to maintain their normal working activities and activities of daily life and receive no further intervention. subjects of both groups are prompted to fill out a weekly online logbook to gather information on their physical activity and neck and/or back complaints. all subjects undergo post-intervention testing at 12 weeks (short term effects), 6 months, and 12 months (long term effects).

Eligibility criteria:
inclusion criteria * age between 18-69 years * perform regular desktop work (at least 20 hours/week) * perform desktop work for at least 1 year (employee or student) exclusion criteria: * documented structural neck- and/or back pathology (confirmed by medical imaging) * known shoulder or vestibular pathology * whiplash-associated disorders * history of surgery in the neck, shoulder, hip, and/or back area * (history of) chronic pain condition * serious headache * serious cardiovascular/metabolic/systemic/neurological conditions * chronic fatigue syndrome * fibromyalgia * psychiatric conditions or history of serious depression * serious catastrophizing thoughts * pregnancy or delivery in the past year

Keywords: desktop workers telework remote work sedentary work primary prevention
dynamic contrast enhanced computed tomography to assess radiation therapy in liver cancer patients

Conditions: Liver Cancer

Summary: this is a pilot study that uses a standard of care technique, stereotactic body radiation therapy (sbrt), in combination with dynamic contrast enhanced computed tomography (dce-ct) to determine if perfusion changes from sbrt of liver cancer may be used for outcome assessment and prediction of prognosis.

patients will undergo standard of care sbrt while also receiving dce-ct, also known as perfusion ct, pre-treatment, 6 hours post-treatment and 6 weeks post-treatment.

Eligibility criteria:
inclusion criteria: 1. provision to sign and date the consent form 2. stated willingness to comply with all study procedures and be available for the duration of the study 3. be a male or female aged 18-100 4. diagnosed with liver hcc or metastases 5. must be receiving or will plan to receive sbrt for liver hcc or metastases exclusion criteria: 1. allergy to iodine contrast 2. ct with contrast not offered as a standard of care 3. pregnant women

Keywords: radiation metastases dynamic contrast enhanced computed tomography pilot
pre-emptive topical lidocaine 5% plaster for prevention of post-craniotomy pain

Conditions: Postoperative Pain; Lidocaine

Summary: postcraniotomy pain remains a common phenomenon in the neurosurgery field. managements for postcraniotomy pain are to be standardised and optimized. in the proposed study, the investigators aim to provide a novel regional non-invasive prophylactic strategy for postcraniotomy pain by utilizing lidocaine 5% plaster.

postcraniotomy pain remains a common phenomenon in the neurosurgery field. insufficient control of postcraniotomy pain may lead to unexpected clinical outcomes. the current management for postcraniotomy pain mainly involves systemic intravenous or oral medication and regional anaesthetic injection. the investigators intend to compare pre-emptive lidocaine 5% plaster incision covering to a placebo for prophylaxis of postcraniotomy pain. in the proposed study, the effectiveness and safety of lidocaine 5% plaster for postcraniotomy pain control will be examined compared with those of placebo. the investigators aim to provide a novel regional non-invasive prophylactic strategy for postcraniotomy pain.

Eligibility criteria:
inclusion criteria: * age of 18 or older * american society of anesthesiologists status i or ii * registered for elective craniotomy * informed consent for participation in the trial exclusion criteria: * allergy to lidocaine or the hydrogel plaster * chronic headache, craniofacial pain or neuralgia * glasgow coma scale less than 15 * current or previous cardiovascular or cerebrovascular accident * expected delayed recovery or extubation * uncontrolled arrhythmia * history of intracranial operation * emergency or revision craniotomy * mental illness, psychiatric drug use or alcohol abuse * failure to understand the use of a 100 mm vas or the pca

Keywords: postoperative pain postcraniotomy pain lidocaine patch
comparing quetiapine xr monotherapy and augmentation with lithium augmentation in trd patients

Conditions: Major Depressive Disorder; Treatment Resistant Depression

Summary: the primary objective of the study is to evaluate the efficacy of quetiapine extended release (xr) in combination with an selective serotonin reuptake inhibitor (ssri) or venlafaxine versus lithium in combination with an selective serotonin reuptake inhibitor or venlafaxine versus quetiapine extended release monotherapy in subjects with treatment resistant depression as assessed by the changes from randomisation to week 6 in the montgomery-åsberg depression rating scale (madrs) total score. as an independent objective, the primary objective will also be evaluated in two subgroups of patients: (1) patients who were resistant to two previous antidepressant therapies and (2) in the subgroup of patients with one previous failure.

the secondary objectives of the study are to compare the effects of the three different treatment regimen as assessed by the following variables and, if applicable, by their changes from randomisation to week 6 (end of study). additionally the time of onset of therapeutic effect will be assessed by evaluating efficacy data after the first four days (day 4) of treatment as well as after the first week of treatment (day 8). these analyses will also be performed in the subgroups of patients with 2 failed previous antidepressants and patients with 1 failure.

Eligibility criteria:
inclusion criteria: * documented clinical diagnosis as confirmed by the m.i.n.i. meeting criteria from the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) for any of the following:296.2x mdd, single episode296.3x mdd, recurrent episode * current episode of depression present, at least 42 days prior to enrolment but not more than 18 months * madrs-score ≥ 25 at enrolment and randomisation exclusion criteria: * patients with a dsm-iv axis i disorder other than mdd within 6 months of randomisation * patients with a diagnosis of dsm-iv axis ii disorder which has a major impact on the patient's current psychiatric status * patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or have made a suicide attempt within the past 6 months

Keywords: depression mdd trd
effectiveness and safety of enbrel® (etanercept) in rheumatoid arthritis subjects who have failed remicade® (infliximab)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the proportion of rheumatoid arthritis (ra) subjects achieving a "good" or "moderate" das28 response (eular28 criteria) at week 16 with etanercept 50 mg subcutaneously (sc) once weekly in patients who have failed infliximab.


Eligibility criteria:
inclusion criteria: * adults with ra (acr criteria) for greater than or equal to 6 months * infliximab treatment for at least 18 weeks * infliximab infusion prior to screening at an increased dosing regimen: 5 mg/kg every 4-8 weeks (dose), or, 3 mg/kg every 4-6 weeks (frequency) * failing infliximab defined by all of the following at screening and baseline visit: disease activity score (das 28) greater than or equal to 4.5, greater than or equal to 5 swollen joints, greater than or equal to 5 tender joints * subjects must be receiving stable methotrexate (mtx), at a dose of greater than or equal to 10 mg/week at least 10 weeks prior to screening * stable disease modifying anti-rheumatic drugs (dmard) therapy (including sulfasalazine, hydroxychloroquine), greater than or equal to 8 weeks prior to screening * stable dose corticosteroids, less than 10 mg/day at greater than or equal to 4 weeks prior to screening * stable dose of non-steroidal anti-inflammatory drugs (nsaids) greater than or equal to 1 week prior to screening exclusion criteria: * acr functional class iv - prior treatment with etanercept * receipt of any investigational drug/biologic within 28 days of study drug initiation * active infection or predisposition to infection * elective surgery planned during study period * intra-articular, soft tissue, or intramuscular corticosteroid injections during 4 weeks prior to screening * contraindications to etanercept as defined in the package insert * severe co-morbidities: history of cancer within 5 years; diagnosis of class iii or iv congestive heart failure (chf); uncontrolled hypertension (htn); cns-demyelinating events suggestive of multiple sclerosis (ms); known hiv-positive status; oxygen-dependent pulmonary status; chronic hepatitis b or c; systemic lupus erythematosus (sle); active or prior history of tuberculosis (tb) (or known exposure) or positive ppd without adequate tb prophylaxis
the relationship between emotion regulation and psychiatric disorder in youth

Conditions: Major Depressive Disorder; Anxiety Disorder; Attention Deficit Hyperactivity Disorder (ADHD); Adjustment Disorder

Summary: according to the increasing worldwide prevalence rate of psychiatric disorders in youth, the mental health of youth is becoming more and more important. taiwan's ministry of health and welfare reported the clibing suicide rate of youth in past five years and showed the prevention work and related intervention for youth's mental health was noteable. the definition of emotion regulation was "consists of the extrinsic and intrinsic processes responsible for monitoring, evaluating, and modifying emotional reactions, especially their intensive and temporal features, to accomplish one's goals." emotion regulation strategies including "rumination", "avoidance", "suppression", "problem-solving", "reappraisal", "acceptance", "social support", and "distraction". previous studies had examined the relationship between emotion regulation and mental health in youth; maladaptive emotion regulation would increase the individual's depressive and anxiety symptoms. carstensen proposed social emotion theory in 1995 selectivity theory (sst) refers to the need for emotion regulation, which activates social participation in late adulthood. sst assumes that young people are more interested in social interaction behaviors related to information seeking and building self-concept. characteristics of youth affected by many normative challenges such as adolescence, school transitions, and more complex social landscape; adaptive emotion regulation will reduce risk of clinical emotion attacks of illness, especially depression and anxiety.to explore the relationship between emotion regulation and mental health from a psychosocial developmental aspect, we focused on the interaction between individual and environment. compared with the previous generation, most youths of this generation were participating in social activities and building up interpersonal relationships through the internet, suggesting the internet was an important social context.


Eligibility criteria:
inclusion criteria: * the inclusion criteria for the control group are as follows: (1) understanding the content of the questionnaire. (2) healthy adolescents aged 15 to less than 18 years and healthy adults aged 18 to 24 years. the inclusion criteria for the experimental group are: 1. understanding the content of the questionnaire. 2. adolescents aged 15 to less than 18 years and adults aged 18 to 24 years. 3. diagnosed with major depressive disorder, anxiety disorder, attention deficit hyperactivity disorder (adhd), or adjustment disorder according to dsm-5. exclusion criteria: * the exclusion criteria for the experimental group are diagnoses of: 1. organic brain injury 2. schizophrenia 3. autism spectrum disorder according to dsm-5.
spot reduction in male adults

Conditions: Healthy

Summary: spot reduction, referring to local body fat reduction, pertains to subcutaneous adipose tissue utilization from specific body parts during exercise. its existence has been keenly debated, although generally accepted not to occur during exercise. however, it is based on not only equivocal data - commonly the training protocol typically applied is based on strength rather than endurance training. the investigators sought to test this assumption by utilizing endurance based exercise controlling for energy expenditure and using dual x-ray absorptiometric measures to assess body composition before and after training.


Eligibility criteria:
inclusion criteria: * males * ≥ 30 years old * classified as overweight (body mass index ≥ 25 kg ∙ m-2) * not participating in regular physical training exclusion criteria: * \< 30 years old * body mass index \< 25 kg ∙ m-2 * participating in regular physical training

Keywords: endurance exercise subcutaneous tissue utilization
retrospective evaluation of cellulite of laxity treatment using body tite

Conditions: Cellulite

Summary: retrospective evaluation of cellulite of laxity treatment using body tite

the purpose of this preliminary report is to retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the sfs using rfal.

Eligibility criteria:
inclusion criteria: * age ≥ 18years of age at the time of procedure * patients with localized lipodystrophy in the medial or lateral thigh, and visible cellulite of laxity in the lower extremity or buttocks * bodytite treatments performed from january 2018 - may 2019 for cellulite indication exclusion criteria: * active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scaring. o bodytite treatments performed from march 2018 - may 2019 for lipodystrophy and cellulite of laxity
evaluation of treatment option for demodicosis in patients undergoing cataract surgery

Conditions: Demodex Infestation; Demodicosis; Cataract

Summary: demodex blepharitis is a prevalent cause of comorbid infection among individuals undergoing cataract surgery. several complications may arise in the postsurgical period from staphylococcus or streptococcus co-infections, as demodex is a vector for these pathogens. hence, prophylactic treatments before cataract surgery may lead to a reduction in complication rates. since demodex infestation and cataract surgery are two prevalent coexisting conditions in the general population, this study aims to test the effect of four combined treatments to eradicate or improve the demodex infestation index before surgery. the investigators are conducting a single-blinded randomized trial of four therapies in participants undergoing cataract surgery. all participants will or are receiving daily eyelid cleansing bid and topical 0.3% ciprofloxacin q4h for three days added to the allocated treatment arm. our four intervention groups are: \[1\] blephaclean eye scrubs; \[2\] 50% dilution baby shampoo; \[3\] tea tree oil shampoo; \[4\]: topical 0.3% ciprofloxacin alone. to assess treatment efficacy, the investigators will perform eyelash hair epilation pre and postoperatively. the primary outcome is a change in the mean demodex spp. infestation index. also, a change in the crude number of demodex (egg, larvae, nymph, or adult-form) spp. in eyelashes after one-week of therapy.


Eligibility criteria:
inclusion criteria: * signed informed consent after explanation of the nature and possible consequences of the study. * clinical diagnosis of cataracts staged with lens opacity classification system iii based on the american academy of ophthalmology and the american society of cataract and refractive surgery guidelines. * no topical antibiotic ointment therapy or eyelid cleansing in the past six months. * no systemic antibiotic or antiparasite treatment in the past six months. * no ocular comorbidities (other than cataracts) * no systemic comorbidities. exclusion criteria: * withdrawal from the study. * minimal changes based on the lens opacity classification system iii.