Kornimate/medical-research-clean huggingface dataset:
molecular pathway activation markers predicting efficacy of trastuzumab therapy for her2-positive breast cancer

Conditions: HER2-positive Breast Cancer

Summary: the purpose of the study is to identify molecular markers at the level of molecular pathway activation to predict efficacy of anti-her2 therapy with trastuzumab.

biopsy and/or surgical samples from her2-positive breast cancer patients treated with trastuzumab alone or in combinations with other regimens of chemotherapy with known clinical outcomes will be collected and subjected to mrna sequencing. expression profiles will be analysed using original bioinformatic platform oncobox. based on comparison of molecular pathways activation strength and clinical response to trastuzumab and chemotherapy, this study aims to identify molecular markers predicting efficacy of therapy with trastuzumab and the possibility of further relapse.

Eligibility criteria:
inclusion criteria: * adult females * histologically confirmed her2-positive breast cancer * available ffpe samples of breast cancer tissue * patients treated with trastuzumab alone or in combination(s) with other regimens of chemotherapy with known outcome according to recist 1.1 * stage ii or more * patients who have signed an informed consent exclusion criteria: * less than 70% of intact tumor cells in available ffpe samples

Keywords: breast cancer epidermal growth factor receptor her2 egfr biomarkers targeted therapy ngs rnaseq mrna transcriptome analysis signaling pathway intracellular molecular pathway oncobox trastuzumab
brain neoplasms, leukemia and petrochemical exposures

Conditions: Leukemia; Brain Neoplasm

Summary: the aim of this study is to examine the association of exposure to air contaminants (pah \& voc) emitted from the petrochemical industries, specific genetic polymorphisms (p4501a1 (mspi \& exon 7) and gstm1 \& t1) of study subjects and their parents, and the risks of brain tumors and leukemia among children and youths in metropolitan kaohsiung, southern taiwan.

brain tumors and leukemia are the most common malignancies among children and adolescents in the u.s. adequate information on the role of inherited genetic susceptibility and environmental exposures in the development of neoplasms in children and adolescents is lacking. in taiwan, four large petrochemical industries are located in the kaohsiung metropolitan area. these facilities are proximal to residential areas because of the high population density in the region. data have shown that the concentrations of ambient polycyclic aromatic hydrocarbons (pah) and volatile organic compounds (voc) around the petrochemical industries are at least 10 and 2 times, respectively, higher than those in u.s. industrialized communities. our preliminary case-control study in metropolitan kaohsiung showed that young residents (under age 30) living within 3 kilometers of the vicinity of petrochemical industries have a 6.0 fold increase in brain neoplasms and a 2.9 fold increase in leukemia. the purpose of this proposal is to examine the association of exposure to air contaminants (pah and voc) emitted from the petrochemical industries, specific genetic polymorphisms (p4501a1 (mspi \& exon 7) and gstm1 \&t1) from study subjects and their parents, and the risks of brain tumors and leukemia among children and youths in metropolitan kaohsiung. our hypothesis is that there is an increased risk of brain tumors and leukemia in patients with high cumulative exposure to these hazards, and that heritable polymorphisms in several genes modify this association. in addition to an independent association of environmental and genetic factors with brain neoplasms and leukemia, we hypothesize that there is greater risk associated with the presence of combined environmental exposure and the high risk genotype. also, we will assess the role of parental genetic polymorphisms in the development of cancer in their siblings. this proposed study uses an environmental molecular epidemiologic approach, utilizing prospective enrollment of a cohort of brain tumor and leukemia subjects in a population-based case-control design. this proposal is responsive to the recommendation of the national research council that risk assessment and public health policy pay special attention to the protection of children.

Eligibility criteria:
young population less than 30 resident of kaohsiung metropolitan, taiwan

Keywords: neoplasm petrochemical leukemia taiwan
digital crowns versus prefabricated crowns on primary teeth

Conditions: Dental Caries in Children

Summary: badly decayed primary molars will be treated by performing the pulp therapy technique indicated, then the patients will be randomized into two groups to receive the restorative intervention. for the intervention group, teeth will be prepared to receive the digital crown after intraoral scanning while for the control group, teeth will be prepared to receive the prefabricated zirconia crowns. teeth will be followed up clinically for 1 year, at 1, 6 and 12 months.

this is a 12-month randomized, controlled, two parallel arms clinical trial. patients aging from 4 to 10 years with multi-surface decay will be selected. after caries removal and pulp exposure, pulpotomy or partial pulpectomy technique will be performed,then the teeth will be randomized to the interventional group of digital crowns or to the control group of prefabricated zirconia crowns. for preparation of digital crowns, the occlusal reduction was done by 1.5-2 mm. the proximal contacts will be broken and the entire clinical crown structure was reduced by 0.8-1.0 mm , followed by a a subgingival finish line . for the scanning procedure, the upper and lower arches will be scanned with intra oral scanner, and making sure every point is well detailed . a third scan of the occlusal bite is then performed in order to establish the patient's occlusion. for the milling procedure, brilliant crios composite the blocks will be used and milled with the cerec mc x milling unit . the inner surface of the crown will be sandblasted with al2o3 . for zirconia crown preparation, occlusal reduction of 1.5-2mm will be performed by a football diamond bur. the occlusal third of the buccal and lingual surfaces will be also reduced . the whole crown will be reduced by 0.8-1.0 mm by means of a tapered diamond stone .a shoulder finish line will be created. the try in crown will be tested, then the shoulder finish line will be removed and the preparation will be extended subgingivally to feather-edge. the crowns will then be cemented with the self-adhesive resin cement (solocem, coltene, whaledent, altstatten, switzerland) .light curing was performed while applying pressure on the crown and then waiting for 5 minutes for complete cementing

Eligibility criteria:
inclusion criteria: * patients within the age group of 4-10years. badly decayed or multi-surface affected primary teeth healthy children free of any systemic disease patients with cooperative behavior rating definitely positive or positive on the frank rating scale exclusion criteria: * teeth with developmental disturbances * teeth with poor prognosis as signs of necrosis, extensive pathological root resorption * patients with parafunctional habits

Keywords: digital crowns zirconia crowns primary teeth
head to head study against sevelamer hydrochloride

Conditions: Chronic Kidney Disease, Stage 5

Summary: to compare the efficacy of fosrenol (lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

to compare the efficacy of fosrenol (lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Eligibility criteria:
inclusion criteria: * adults with end stage renal disease who are receiving dialysis exclusion criteria: * subjects with significant gastrointestinal disorders * subjects who are pregnant or nursing * subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride * subjects who are hiv positive * subjects with clinical significant liver disease
symptom-based markers for covid-19 transmission

Conditions: Covid19

Summary: in this study, covid-19 positive patients will be added to a bidirectional texting program to receive daily surveys about their symptoms with the infection. this data will further the understanding of covid-19 symptom development throughout the infection period, as well as how those symptoms vary at different points of the day. this study will be a single cohort, observational study of covid-19 patients.

one important approach for decreasing covid-19 transmission in healthcare settings is to prevent healthcare professionals from working while ill. currently, facilities are asking screening questions and measuring temperatures to help identify symptomatic healthcare professionals and exclude them from providing patient care. simulations can be used to inform the effectiveness of different screening approaches, but the results of these simulations depend upon the effectiveness of the intervention, e.g., the ability to identify healthcare professionals on their way to work, or to study the impact of healthcare professionals returning to work too early. thus, simulations must necessarily depend upon realistic disease parameters: for example, it is suspected that a non-trivial proportion of patients with covid-19 may be asymptomatic or have minimal symptoms, but the relative size of the asymptomatic subpopulation is unknown. the plan for this study is to develop a method for granular measurement of twice-daily symptoms from healthcare professionals and other research subjects of similar ages. after being diagnosed, the goal is to determine what symptoms participants have and how long they have had them. this will be done using a previously-developed bidirectional texting platform to query participants about symptoms at least twice a day for ten days post diagnosis. participants will be asked about subjective symptoms, including fevers, chills, cough, shortness of breath, fatigue, gastrointestinal symptoms, etc. they will also take their temperature twice daily during the recovery period, which will help determine the effectiveness of screening based on symptoms and/or thermometer readings.

Eligibility criteria:
inclusion criteria: * fluent in english * tested positive for covid-19 exclusion criteria: * prisoners * unable to provide own informed consent
the effect of non-invasive vagal nerve stimulation combined with self-managed therapy in individuals with myogenic temporomandibular dysfunction

Conditions: Temporomandibular Disorders (TMD)

Summary: the aim of our study is to determine the benefit of non-invasive vagal nerve stimulation in combination with self-administered therapy on the symptoms associated with jaw joint dysfunction in individuals with jaw joint dysfunction. if you agree to participate in the study, you will fill out a form containing your information such as age, height, body weight. then, visual analog scale (vas) and central sensitisation scale will be used to assess the severity of jaw and neck joint pain. the 8-question jaw function restriction scale will be used to assess the limitation of jaw function. an algometer will be used to evaluate the pressure-pain threshold, and therabite range of motion scale will be used to evaluate the range of motion of the jaw joint. one photograph will be taken from the side profile to evaluate the head-neck posture, this photograph will be used for craniocervical angle measurement and will not be shared elsewhere. myotonmetry will be used to evaluate muscle mechanical properties and non-invasive superficial electromyography (yemg) will be used to evaluate muscle activation. the treatments to be applied within the scope of the study will be carried out 3 days a week and the evaluation sessions will last 30 minutes.


Eligibility criteria:
inclusion criteria: * between the ages of 18-45, * diagnosed with myogenic tmds according to tmd-dc axis i and ii criteria, * pain intensity of 3 or more during rest and/or chewing according to the visual analogue scale, * volunteered to participate in the study and signed the informed consent form, * individuals who do not have communication difficulties and whose native language is turkish will be included in the study. exclusion criteria: * diagnosed with arthrogenic or mixed type tmds, * severe psychiatric illness such as schizophrenia, * previous vagal nerve stimulation or history of vagotomy, * have extensive joint damage affecting the jaw, head, neck and shoulder areas, have a history of major trauma, fracture or surgery to these body parts, or are undergoing radiotherapy, * diagnosed with cervical disc herniation, cervical radiculopathy or cervical myelopathy, * history of cardiac disease and being treated for cardiac problems, * active implant users such as pacemakers, defibrillators, neurostimulators, cochlear implants and ventricular shunts, * failure to understand the study protocol * have a history of progressive neurological diseases (such as parkinson's disease, ms, als, epilepsy, alzheimer's disease) * acute tinnitus * skin problems such as dermatitis, infection, psoriasis, urticaria, acne or eczema at the stimulation site, * has any anatomical abnormality that prevents successful placement of the ear electrode, * and reporting acute tinnitus, * pregnant subjects will be excluded from the study

Keywords: myogenic temporomandibular disorders transcutaneous vagal nerve stimulation pain self-menaged therapy posture muscle activation muscle stiffness
a phase i study of gzr18 injection in obese/overweight subjects

Conditions: Overweight and Obesity

Summary: this is a randomized, double-blind, placebo-controlled, dose-escalation phase i clinical study. a sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and pk/pd characteristics of gzr18 injection in chinese obese/overweight subjects.


Eligibility criteria:
inclusion criteria: * subjects sign the informed consent form (icf) voluntarily. * chinese adult subjects, both male and female. * 18 to 65 years old (including both ends) at screening. * bmi≥26.0 kg/m2 at screening. * stable weight before screening (i.e. self-reported weight change less than 5 kg within 8 weeks before screening). * female subjects have negative serum human chorionic gonadotropin (hcg) during screening and baseline periods. * subjects have good daily habits and can maintain good communication with investigators and comply with various requirements of clinical trials. exclusion criteria: * lactating women. * history of fainting with blood and needles. * known or suspected allergy to study related products; or drug/food allergy history; or allergy-related diseases history. * subjects who have participated in other clinical trials and given investigational drugs or medical device interventions within 90 days before screening. * history of drug abuse within 1 year before screening, or positive results in drug abuse screening (urine). * smokers who smoke ≥ 5 cigarettes per day within the previous 3 months before screening or cannot refrain from smoking throughout the trial period. * any vaccine has been used within 28 days before administration, as well as any vaccine that may be used throughout the trial period. * other scenarios judged by the investigator to render the subjects unsuitable for participating in this study.
a study to investigate the effect of asp1517 after intermittent oral dosing in dialysis chronic kidney disease patients with anemia compared with darbepoetin as a reference drug

Conditions: Renal Anemia Associated With Chronic Renal Failure (CRF)

Summary: this study is to evaluate safety and efficacy of intermittent oral dosing of asp1517 in dialysis chronic kidney disease patients with anemia.

to evaluate the safety and the dose-response of asp1517 on hemoglobin (hb) correction when asp1517 is applied intermittently in dialysis chronic kidney disease patients with anemia. to evaluate the treatment effect on hb maintenance of asp1517 administered intermittently in dialysis chronic kidney disease patients with anemia.

Eligibility criteria:
inclusion criteria: * patients who diagnosed as a end-stage kidney disease (eskd) and are receiving stable chronic maintenance dialysis 3 times per week for ≥ 12 weeks * patients who are receiving esa for at least 8 weeks and the dose of esa is within the dose range of esa label * hb value at screening test is ≥10.0 g/dl * receiving hemodialysis via arteriovenous fistula (avf) or arteriovenous graft (avg) or via permanent catheter * most recent two hb values before dialysis during washout period must be both \<9.5 g/dl and one of two hb values must be tested on first visit of the week exclusion criteria: * proliferative retinopathy, age-related macular degeneration, retinal vein occlusion and/or macular edema that is considered to require treatment * immunological disease with severe inflammation as assessed by the investigator; even if the inflammation is in remission, the subject is excluded (e.g. lupus erythematosus, rheumatoid arthritis, sjogren's syndrome, celiac disease, etc) * having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract or active gastroparesis * uncontrollable hypertension (sbp ≥160 mmhg and dbp ≥110 mmhg, before dialysis, at screening test) * congestive heart failure (nyha classification iii or higher) * having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before 1st registration * positive for any of the following: human immunodeficiency virus (hiv); hepatitis b surface antigen (hbsag); or anti-hepatitis c virus antibody (anti-hcv ab) * anemia other than anemia due to low/absent renal production of epo (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc) * pure red cell aplasia * using anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before 1st registration

Keywords: chronic renal failure asp1517 renal anemia
visual performance of bilateral acrysof restor aspheric +4

Conditions: Cataract

Summary: determine the clinical visual outcomes following bilateral implantation of the acrysof restor aspheric intraocular lens (iol) and to demonstrate what percentage of the subjects obtain spectacle freedom.


Eligibility criteria:
inclusion criteria: * diagnosed with cataracts exclusion criteria: * preexisting conditions confounding results; \> 1 diopter preoperative astigmatism

Keywords: acrysof restor aspheric +4
effects of nocturnal non-invasive ventilation on energy expenditure in patients with severe chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation; Non-invasive Ventilation; Energy Expenditure

Summary: it has been shown, that in patients with very severe chronic obstructive pulmonary disease (copd) the additional use of non-invasive ventilation during pulmonary rehabilitation (pr) may enhance the benefits of pr. it is assumed that the non-invasive ventilation techniques provides a better recovery of the respiratory pump during the night. if non-invasive ventilation also decreases the metabolic demands during night is unknown and is aim of this study. during a 3 week inpatient pulmonary rehabilitation program a total of 85 patients with chronic obstructive pulmonary disease stage iv will be recruited for this study. there will be a 4:1 distribution into 2 groups. 68 patients with an indication for the use of a non-invasive ventilation will be involved in the intervention group where non-invasive ventilation will be initialized. 17 patients with chronic obstructive pulmonary disease stage iv without an indication for the use of non-invasive ventilation will be involved in a control group to detect the changes in nocturnal energy expenditure produced by pulmonary rehabilitation alone. all outcome measurements will be performed during day 1-3 and will be repeated after 12 days (with or without non-invasive ventilation) at day 15-17 of the pulmonary rehabilitation program. a sub-trial of this study is to validate night movement accuracy of the dynaport activity monitor with the observations made by a night-vision camera in the sleep lab. this will be performed in study participants as well as in healthy volunteers.


Eligibility criteria:
inclusion criteria for intervention group: * chronic obstructive pulmonary disease stage iv * indication for the use of a nocturnal non-invasive ventilation (according to the german guidelines schoenhofer et al. 2008) * patient has not yet used non-invasive ventilation at all or inadequately (less than 3 hours per day) exclusion criteria for intervention group: * acute exacerbation of chronic obstructive pulmonary disease * severe heart failure * body-mass-index \>35 m²/kg * fever inclusion criteria for control group: * chronic obstructive pulmonary disease stage iv (- healthy volunteers are also eligible for the sub-trial of this study to validate night movement accuracy of an activity monitor) exclusion criteria for control group: * acute exacerbation of chronic obstructive pulmonary disease * indication for the use of a non-invasive ventilation * severe heart failure * body-mass-index \>35 m²/kg * fever
phase 2 study of ipilimumab in children and adolescents (12 to < 18 years) with previously treated or untreated, unresectable stage iii or stage lv malignant melanoma

Conditions: Malignant Melanoma

Summary: the purpose of the study is to comply with the pediatric investigation plan requirements of ipilimumab


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * 12 \< 18 years of age * previously treated or untreated, unresectable stage iii or stage iv malignant melanoma * karnofsky performance status (kps) or lansky score ≥ 50 exclusion criteria: * primary ocular melanoma * prior therapy with a cytotoxic t lymphocyte antigen 4 (ctla-4) or programmed death- 1 (pd-1) antagonist, or programmed cell death- ligand 1 (pd-l1) or cd137 agonists * symptomatic brain metastases * history of autoimmune diseases
effects of novel e-cigarette constituents on adults tcors 3.0

Conditions: Nicotine Use Disorder

Summary: this study is an examination of the influence of cooling components of ws-3, ws-23, and menthol on the appeal and addiction potential of nicotine-containing e-liquids among adults.

the investigators will examine the influence of cooling components of ws-3, ws-23 (synthetic coolants) and menthol on the appeal and addiction potential of nicotine-containing e-liquids among adults. participants will rate the flavor intensity, coolness, sweetness, and irritation/harshness, bitterness experienced using validated rating scales. 66 adult participants (18+ years of age) who are current e-cigarette users will participate in 3 laboratory sessions. participants will receive 3 e-cigarette that contain cooling flavors and nicotine (59mg/ml nicotine salt) during the sessions. participants will be randomized to receive one of the 3 menthol conditions (no-menthol, low menthol, high menthol) in combination three ws-3 conditions (no ws-3, low ws-3, high ws-3) and two ws-23 conditions (low ws-23, high ws-23). all participants will be exposed to all fifteen conditions across 3 lab sessions.

Eligibility criteria:
inclusion criteria: * 18 years or older * able to read and write * some current e-cigarette use * willing to abstain from tobacco/nicotine use 2 hours prior to sessions exclusion criteria: * current use of non-prescription substances besides nicotine, marijuana, alcohol * any significant current medical or psychiatric condition * known hypersensitivity to propylene glycol * pregnant or lactating females * uncontrolled asthma * nut/e-liquid flavorant allergy * current marijuana (tetrahydrocannabinol) vaping + e-cigarette or vaping use associated lung injury (evali) symptoms

Keywords: menthol, cooling components, cigarette, e-cigarette, vaping