Kornimate/medical-research-clean huggingface dataset:
tumor suppressor status as a predictor of chemotherapy response in triple negative breast cancer

Conditions: Breast Cancer

Summary: this is a prospective observational study aimed to validate biomarkers that predict response.

this is a prospective observational cohort study, with no control group and no direct experimental intervention, where the patient's pathological material will be used to examine the expression of molecular biomarkers believed to predict chemotherapy response. patients with locally advanced triple negative breast cancer, who are candidates for neoadjuvant chemotherapy, will be enrolled in this clinical study. patients will receive standard of care, fda-approved and clinically validated chemotherapy regimens. the biopsy specimens taken during the diagnostic phase (pre-treatment specimen) will be used for specific biomarker evaluation. data obtained from this pre-treatment phase will be compared with the surgical specimens (post-treatment phase) obtained after receiving neoadjuvant chemotherapy. the primary endpoint is to assess the ability of specific biomarkers to predict treatment response, and thus identify those patients who will achieve benefit from such treatment.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * histologically-confirmed triple negative invasive breast carcinoma * any type of ductal or lobular invasive carcinoma * patients with or without brca-1 and brca-2 mutations are eligible to participate * life expectancy \> 6 months * pre-, peri- or postmenopausal * clinical stage t2-4, n0-3, m0 (stage ii-iii) * patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial * adequate hematologic, renal, and liver function and functional status that permit chemotherapy administration. however, these parameters will be evaluated by the treating physician, and decisions regarding eligibility for chemotherapy or surgery will be made on a case by case scenario. exclusion criteria: * prior history of and/or active therapy for invasive breast cancer (includes chemotherapy, radiation, hormonal therapy including ais, tamoxifen, raloxifene, fulvestrant or any other antiestrogen/serm) * patients with a "currently active" second malignancy other than non-melanoma skin cancers are not to be registered. patients are not considered to have a "currently active" malignancy if they have completed therapy and are now considered to be at less than 30% risk for relapse (by their physician). * only ductal/lobular carcinoma in situ but not invasive component * any sort of confirmed metastatic disease (ajcc stage iv at diagnosis) * any sort of active local radiation therapy (to the breast or the axilla), before the neoadjuvant chemotherapy * pregnant or lactating, in case this precludes the subject to receive chemotherapy. * impossibility to receive neoadjuvant chemotherapy due to significant medical comorbidities, allergies or performance status. this will be exclusively decided by the treating oncologists.

Keywords: triple negative breast cancer rb pten chemotherapy neoadjuvant
soluble urokinase plasminogen activator receptor (supar) in late-onset neonatal sepsis

Conditions: Neonatal Sepsis

Summary: the purpose of the study is to investigate the plasma levels of soluble urokinase plasminogen activator receptor (supar) at the diagnosis and after treatment of sepsis, and to determine whether it has a diagnostic and prognostic value in late-onset neonatal sepsis.

infection is a leading cause of neonatal morbidity and mortality worldwide. the clinical presentation of neonatal infection is subtle and nonspecific. microbiologic cultures of clinical specimens, the gold standard for diagnosis, have low sensitivity and are not available in time to influence initial therapy. therefore, reliable and rapid in vitro tests are needed for early diagnosis and management of infection in neonates. supar, secreted from the cells (neutrophils, lymphocytes, macrophages, endothelial cells) has recently been reported to be a potential biomarker for several infection diseases. the levels of supar have not been studied in newborn infants yet.

Eligibility criteria:
inclusion criteria: * infants with late-onset neonatal sepsis exclusion criteria: * infants without parents' consent

Keywords: sepsis late-onset supar
the effect of aerobic exercise on cognitive function and sleep quality in individuals with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: in addition to the typical motor and sensory impairments, individuals with multiple sclerosis (ms) often experience cognitive dysfunction and sleep disturbances. cognitive impairment occurs in 40 % - 70% of patients with ms. in addition, sleep problems in individuals with ms are very common, and approximately 50% of patients with ms have a diagnosable sleep disorder. the research believes that aerobic exercise improve cognitive function and improve sleep quality.


Eligibility criteria:
inclusion criteria: * diagnosis of relapsing remitting or secondary progressive ms * score 3-7 on the edss * score \< 55 on the symbol digit modalities test * score \> 5 on the pittsburgh sleep quality index exclusion criteria: * history of alcohol/drug abuse or nervous system disorder other than ms * severe physical, neurological, or sensory impairments that would interfere significantly with testing * developmental history of learning disability or attention-deficit/hyperactivity disorder * relapse and/or corticosteroid use within four weeks of assessment * unable to give consent * uncorrected vision loss that would interfere significantly with testing * score less than 24 on mmse * acute ischemic cardiovascular event or coronary artery bypass surgery less than 3 months ago * either unable to physically perform the exercise test using the recumbent stepper or demonstrate absolute indications for terminating exercise that follows the american college of sports medicine's (acsm) guidelines * uncontrolled blood pressure with medication (bp \> 190/110mmhg)
hypercoagulable phenotype by thrombinography (in presence of c protein dynamic inhibitory system)

Conditions: Venous Thrombosis

Summary: the purpose is to determine the hypercoagulable phenotype by thrombinography associated to an increased risk of symptomatic and objectively confirmed first venous thrombotic event. this is a case-control study in a population with patients having systemic lupus erythematosus (sle) and/or antiphospholipid antibodies (apl). secondary purposes are: 1. to determine the frequency of hypercoagulable phenotype in study population; 2. to analyze the sensibility: consequences of variation of hypercoagulable phenotype threshold on the importance of risk; 3. to identify (genetic and not) factors for hypercoagulable phenotype and their frequency in different groups.


Eligibility criteria:
inclusion criteria: cases : * patients with sle and/or apl and first documented deep vein thrombosis episode (minimum 6 months, maximum 6 years) * any weight and height * absence of current anticoagulant treatment but possibility of platelet function inhibitory treatment; actual guidelines suggest long-term anticoagulant treatment in patients with first episode of venous thrombosis and having apl; however, these patients can be studied if they are in one of these circumstances: 1/ "inconvenient" stop by patient, 2/ aspirin decided by doctor after prolonged treatment controls: * patients with sle and/or apl without thrombosis (venous or arterial) * any weight and height * possibility of platelet function inhibitory treatment (primary prophylaxis of arterial manifestations) exclusion criteria: cases and controls : * pregnancy * refusal of consent * difficulty of follow-up (not sufficient motivation)

Keywords: systemic lupus erythematosus antiphospholipid syndrome antiphospholipid antibodies
comparison of two protocols for deflation of radial band following coronary procedures via the radial artery

Conditions: Coronary Artery Disease; Radial Artery Injury

Summary: coronary angiography is now mainly performed via the radial route rather than the femoral route. at the end of the procedure, the sheath is removed and a band is inflated to obtain hemostasis. the air in the band is then deflated at regular intervals. currently there are different protocols for deflation of the band, but none of these have been studied with regards to patient comfort and time of deflation, and potential complications such as bleeding. here in this study the investigators wish to compare two such protocols of band deflation and assess the levels of patient comfort and time to discharge with two widely used protocols.

coronary angiography is a procedure by which the anatomy of the coronary arteries are studied. it can be done either via the radial artery approach or the femoral artery approach. currently most centers use the radial artery approach due to the lower risk of access site bleeding as compared to the femoral artery approach. in addition, the radial approach allows earlier patient mobilisation after the procedure. once the sheath, through which the procedure is done, is removed, a special air filled band is used to compress the artery to prevent bleeding. this involves filling the band with around 18 ml of air and then releasing the air at periodic intervals. there are however no set protocols for the removal of air and literature often suggests varying protocols. however what the protocols try to achieve is proper hemostasis, with low incidence of radial artery occlusion. in addition to these, patient comfort and safety along with staff ease of use is important. some protocols involve frequent deflations which might be more tedious for the nurses, but more comfortable for patients whilst others might be easier for the staff (due to longer intervals), but more uncomfortable for the patients. however, there are no studies that actually compare these protocols

Eligibility criteria:
inclusion criteria: * all patients undergoing coronary procedures via the radial route exclusion criteria: * those below the age of 18 and those unable to give consent

Keywords: coronary angiogram radial artery
evaluation of new fitting characteristics for extended wear hearing aid technology

Conditions: Hearing Loss

Summary: two groups of hearing aid candidates will be fit with extended wear technology. one group will be fit with the commercially available models, and the other group will be fit with either the commercially available model or a new model with different fitting characteristic. after an appropriate trial period, the success rate of each group will be determined by the desire to purchase devices.

hearing aid candidates will be assigned to either group a or group b. group a will be fit only with extended wear devices that are commercially available. group b will be fit with either the commercially available devices, or a set of devices that have a new fitting characteristic, depending on what is most appropriate and the best fit. because extended wear devices are inserted by a hearing care professional and sit deep within the ear canal, participants will be blinded as to which devices they are wearing. after a typical hearing aid trial period (i.e. 30 days), participants will be asked to make a determination on whether they would purchase if given the option. the percentage of people that indicate a desire to purchase devices from group a will be compared to the percentage of people that indicate a desire to purchase devices from group b to determine if the offering of additional fitting options results in an increase in intent to purchase, or a trial to success rate.

Eligibility criteria:
inclusion criteria: * mild to moderate hearing loss * new hearing aid users with no previous hearing aid experience interested in trying lyric devices * must meet lyric candidacy (see exclusion criteria) exclusion criteria: * middle ear disease, including but not limited to history of tympanic membrane perforations, chronic otitis media, cholesteatoma, pe tubes * radiation therapy to head or neck area * participants who need regular mri testing * participants who regularly scuba dive or swim underwater
safety and efficacy study of nbi-98854 in adults with tourette syndrome

Conditions: Tourette Syndrome

Summary: phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of nbi-98854 administered once daily (qd) for a total of 8 weeks of treatment. this study will enroll approximately 90 male and female subjects clinically diagnosed with tourette syndrome.


Eligibility criteria:
inclusion criteria: 1. have a clinical diagnosis of tourette syndrome (ts) 2. have at least moderate tic severity 3. have ts symptoms that impair school, occupational, and/or social function 4. if using maintenance medication(s) for ts or ts spectrum diagnoses (e.g. obsessive-compulsive disorder \[ocd\], attention-deficit hyperactivity disorder \[adhd\]), be on stable doses 5. be in good general health 6. have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates, and a negative alcohol screen 7. subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study exclusion criteria: 1. have an active, clinically significant unstable medical condition within 1 month prior to screening 2. have a known history of long qt syndrome or cardiac tachy-arrhythmia 3. have a known history of neuroleptic malignant syndrome 4. have a cancer diagnosis within 3 years prior to screening (some exceptions allowed) 5. have an allergy, hypersensitivity, or intolerance to vmat2 inhibitors 6. have a known history of substance dependence, substance (drug) or alcohol abuse 7. have a significant risk of suicidal or violent behavior 8. are currently pregnant or breastfeeding 9. have initiated comprehensive behavioral intervention for tics (cbit) during the screening period or at baseline or plan to initiate cbit during the study 10. have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than nbi-98854) during the study 11. have a blood loss ≥550 ml or donated blood within 30 days prior to screening
biomarker-s of abusive head trauma by proteomics

Conditions: Abuse, Child; Protein Disorder, Blood

Summary: the aim of our study is to highlight biomarker-s of abusive head trauma by proteomics analyses on the serum of child victims of abuse.


Eligibility criteria:
inclusion criteria: * age : 0-2 y.o * medical consultation for malaise, seizure (without fever), loss of consciousness, traumatic bain injury, or cranioplasty * blood test during medical care * accepted informed consent exclusion criteria: * refused informed consent * for control groups : medical history of child abuse * for aht group : rare metabolic disease (menkes, etc..)

Keywords: abusive head trauma proteomic biomarker
improvement in urine collection methods in children

Conditions: Urinary Tract Infection; Unspecified Fever

Summary: the population of children presenting to the emergency department (ed) for treatment increases day by day, creating a further burden on the limited nursing staff and where many children and their parents are forced to wait many hours until their medical investigation ends. part of the many hours waited are for various tests the patient has to undergo, where the urine test is one of the main ones. urinary tract infections in children are a common cause of death due to acute and chronic complications alike. our study aims to test a urine collection method to see whether it reduces parents' and/or nursing staff's involvement and thereby reducing the urine sample's percentage of contamination.

the study intends to explore whether on obtaining a pediatric urine sample by using a diaper in an innovative way can shorten the waiting time parents have to endure until an urine sample is perceived, and accordingly, the percentage of contamination in the samples obtained. the innovativeness introduced is that by using an ordinary everyday diaper, which is found in all marketing outlets, and by making a slit in the diaper where the pediatric urine collecting bag can be pulled out and thus allowing parents/care takers to see straight away whether urine has been given and thus cut back on opening and reopening of the diaper.

Eligibility criteria:
inclusion criteria: 1. children incapable of giving urine voluntarily in the emergency department 2. children requiring an urine test 3. children whose parents have agreed to take part in the research and have signed a consent form exclusion criteria: 1. children who have an immediate medical condition which requires catheterization 2. parents who have declined taking part in the research 3. children who give urine voluntarily 4. children who do not need an urine test for their continued treatment

Keywords: urine collection, contamination
pharmacokinetics and safety of topical administration of brimonidine tartrate ophthalmic solution 0.025%.

Conditions: Hyperemia

Summary: to characterize the plasma pharmacokinetics and safety profile of brimonidine following a single dose and 4 times per day (qid) dosing of brimonidine tartrate ophthalmic solution 0.025% for 7 days in healthy, adult subjects.


Eligibility criteria:
inclusion criteria: * have ocular health within normal limits. * have blood (hematology, blood chemistry) and urine analysis within normal limits. * have a body weight within 15% of ideal weight exclusion criteria: * have known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medications required by the protocol; * have any active systemic or ocular disorder other than refractive disorder. * have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that in the investigator's opinion could affect ophthalmic drop absorption. * have a history of chronic alcohol consumption. * consume alcohol and/or caffeine or xanthine containing products within 48 hours prior to dosing at visit 1 or anticipated use during the study. * have a history of tobacco, nicotine, or nicotine containing product use within the last year prior to visit 2; * have significant weight change (over 10 pounds) within the 60 days prior to visit 2; * have blood donation or equivalent blood loss of 450 ml or more, within 60 days prior to visit 2; * have an abnormal blood pressure (defined as ≤ 90 or ≥ 160 (systolic) measured in mmhg or ≤ 60 or ≥ 100 (diastolic) measured in mmhg); * have intraocular pressure (iop) that is less than 5 mmhg or greater than 22 mmhg or have a normal iop with a diagnosis of glaucoma.

Keywords: ocular redness
copenheartvr - integrated rehabilitation of patients after heart valve surgery

Conditions: Heart Valve Disease

Summary: the aim of the study is to investigate the effect of an integrated rehabilitation programme, consisting of physical exercise training and psycho-educational consultations, for patients after heart valve surgery. the hypothesis is that integrated rehabilitation can improve physical capacity measured by v02 peak, self-rated mental health and life quality by validated questionnaires such as sf-36, and other objective parameters such as cardiac-specific biomarkers and echocardiographic measurements.

worldwide, the incidence of heart valve disease is increasing. improved surgical techniques, rising age and possibility for re-operation leads to a rising number of patients having heart valve surgery. the gap between hospital discharge and returning to normal life is obvious. integrated rehabilitation could probably reduce hospital readmissions, increase physical capacity and increase self-rated mental health and quality of life. therefore the aim of this study is to explore if patients after heart valve surgery will benefit from an integrated rehabilitation programme consisting of physical exercise and psycho-educational intervention. a randomized clinical trial is conducted to investigate the effect and meaning of an integrated rehabilitation programme on the physical and psychosocial functioning of patients after heart valve surgery. the trial is a parallel arm design. a mixed methods embedded experimental design is chosen to include both quantitative and qualitative data to evaluate the intervention. the intervention consists of five psycho-educational consultations provided by specialized nurses and a twelve week individualized exercise training programme provided by physiotherapists. a qualitative post-intervention study will explore rehabilitation participation experiences. along with the above stated hypothesis, it will be observed whether integrated rehabilitation can reduce anxiety, depression, health care utilisation, mortality and work cessation. 210 patients will be included. validated questionnaires (e.g. sf-36), cardiopulmonary exercise testing, 6 minute walking test, echocardiography, cardiac-specific biomarkers and qualitative interviews will be used to evaluate the effect and meaning of the programme.

Eligibility criteria:
inclusion criteria: * admitted to hospital for elective heart valve surgery at rigshospitalet, denmark * 18 years or older * speak and understand danish * providing written informed consent exclusion criteria: * known ischemic heart disease prior to heart valve surgery * is included in an other clinical trial investigating the effects of physical training and psycho-educational intervention * unable to understand and cooperate to study instructions * pregnant and/or breast feeding * performing exercise training at high level and several times a week * no written informed consent

Keywords: rehabilitation integrated rehabilitation programme exercise training psycho-educational care
the cervical trident study

Conditions: Facet Joint Pain

Summary: this observational retrospective study evaluates the efficacy of rf with the three-tined expandable electrode needle compared to before treatment in the treatment of chronic cervical facet joint pain.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * patients with neck pain * patient who had two diagnostic medial branch blocks with significant (\>50%) improvement on both injections. exclusion criteria: - no patient related outcome measures available in hospital's patient charts