Kornimate/medical-research-clean huggingface dataset:
methionine and pbr28-pet (peripheral benzodiazepine receptors) in brain metastases following radiosurgery

Conditions: Brain Metastasis

Summary: the goal of this protocol is to evaluate the potential of pet imaging of amino acid transport and microglial activation to improve the differentiation of tumor recurrence and radiation necrosis in patients with brain metastases after treatment with stereotactic radiosurgery (srs) who have re-growing lesions. these state-of-the-art imaging tools will be used in combination with standard magnetic resonance imaging (mri), mr spectroscopy (mrs) and fdg-pet (fluorodeoxyglucose).

the investigators hypothesize that by using two different pet tracers, one sensitive to tumor metabolic activity, and one sensitive to inflammatory processes, investigators can separately identify metabolically active tumor from radiation necrosis related inflammation. this can be accomplished with quantitative assessments of tracer uptake using kinetic modeling techniques, as well as by high-resolution imaging to assess the distribution of tracer uptake in the tumor region. all participants in the study will have the receive the same diagnostic tests.

Eligibility criteria:
inclusion criteria: * patients over 18 years with brain metastases from melanoma or non-small cell lung cancer * patients must have had srs and regrowth in at least one lesion \> 0.5 cm in greatest dimension and fall into one of two categories: a) patient is deemed clinically appropriate for surgical intervention (biopsy or craniotomy) or b) patient is asymptomatic and has a life expectancy of \> 6 months so that serial follow-up imaging is appropriate * willingness to participate in imaging studies * able to give informed consent exclusion criteria: * subjects with history of prior radiation exposure for research purposes within the past year, such that participation in this study would place them over the fda limits for annual radiation exposure. this guideline is an effective dose of 5 rem received per year. * subjects who are pregnant or currently breastfeeding * women of child-bearing age who are sexually active, unless they agree to two forms of contraception, and have a negative urine pregnancy test at screening and on the days of the pet imaging * patients unable to undergo mri with gadolinium-based contrast for standard clinical reasons which include: * cardiac pacemaker, aneurysm clip, cochlear implants, intra uterine device (iud), shrapnel, neurostimulators, defibrillator, artificial heart valve, or history of metal fragments in eyes. * pregnancy * body size too large for closed mri * known hepatic fibrosis. * claustrophobia * contraindication to mr contrast agents: egfr (epidermal growth factor receptor) \ 60 years old or with chronic renal disease * anaphylactic allergy to gadolinium

Keywords: regrowth radiosurgery radiation necrosis
comparison of postoperative early period quality of life of patients with open and robot assisted kidney transplantation

Conditions: Quality of Life

Summary: the investigators aimed to investigate the quality of life in patients with end-stage renal disease who underwent open or robot-assisted renal transplantation. also, the investigators sought to determine the parameters which can affect the quality of life in these patients

patients who underwent open or robot-assisted renal transplantation at bakirkoy sadi konuk training and research hospital between june 2016 and december 2018 constituted the target population of this study. after application of the inclusion and exclusion criteria, the patient group was divided into two groups as per the surgical technique (i.e., open vs. robot-assisted). demographic data, preoperative and postoperative data of all patients were collected prospectively. the quality of life of the patients was assessed preoperatively and on the postoperative 30th day

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 75 * who were diagnosed with end stage renal disease (i.e., estimated glomerular filtration rate loer than 20 ml/minute or symptomatic uremia or dialysis requirement) * received a kidney from a live donor exclusion criteria: * patients with mental retardation, dementia, and psychotic or cognitive disorders, including delirium * patients who underwent deceased renal transplantation and who underwent simple bilateral nephrectomy or any other surgical procedure concurrent with open renal transplantation * patients who died or had graft failure during the study period

Keywords: end stage renal disease renal transplantation quality of life
does acne rash during adolescence predict skin reaction to cetuximab

Conditions: Colorectal Cancer Metastatic

Summary: the hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.

the hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab

Eligibility criteria:
inclusion criteria: * age above 18 years. * histology or cytology proven kras-wt mcrc. * performance status ≤3 (eastern cooperative oncology group \[ecog\] classification) * life expectancy of more than 12 weeks. * written informed consent. * in women of childbearing potential, appropriate contraceptive measures must be used during treatment with cetuximab and for 6 months following the last dose of cetuximab. exclusion criteria: * past systemic immune therapy for disease other than cancer. * past immune or other target therapy for cancer (not including bevacizumab). * presence of acne or acneiform rash prior to starting treatment with cetuximab. * patients with treatment plan of cetuximab and capecitabine combination. * for female patients: the patient is pregnant or lactating.

Keywords: skin rash reaction erbitux® (cetuximab) acne
safety, tolerability and efficacy of indacaterol in patients with moderate-to-severe chronic obstructive pulmonary disease (copd)

Conditions: COPD

Summary: this study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of chronic obstructive pulmonary disease (copd) patients


Eligibility criteria:
inclusion criteria: * patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study b2335s at visit 14 (the last visit of the core study b2335s and the first visit of the extension study b2335se). * in addition the following inclusion/exclusion criteria specified below must be met. 1. patients must complete stage 2 of the core study b2335s (nct00463567). 2. written informed consent to participate in the extension must be obtained. 3. patients must be able to comply with all study requirements. exclusion criteria: * patients who were randomized to open-label tiotropium in study b2335s. * patients who participated in stage 1 of the core study (b2335s). * patients discontinued irrespective of the reason from stage 2 of the core study. * patients who fail to comply with the core protocol requirements and procedures. * concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol. * patients who in the investigator's opinion should not participate in the extension study. other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd adults β2-agonist indacaterol
phase 3 study with ciprofloxacin dispersion for inhalation in non-cf bronchiectasis (orbit-3)

Conditions: Non Cystic Fibrosis Bronchiectasis

Summary: this study (ard-3150-1201, orbit-3) will evaluate the safety and efficacy of inhaled pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-cf) bronchiectasis with a history of pulmonary exacerbations and chronic p. aeruginosa infections.


Eligibility criteria:
inclusion criteria: * verified bronchiectasis diagnosis * pseudomonas aeruginosa lung infection exclusion criteria: * cystic fibrosis

Keywords: bronchiectasis, non-cf, ciprofloxacin, liposome
safety and efficacy study of shp465 in adults aged 18-55 years with attention-deficit/ hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: the study is designed to evaluate the efficacy and safety of each dose of shp465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with adhd.


Eligibility criteria:
inclusion criteria: subject must be 18-55 years of age subject is able to provide written, personally signed and dated informed consent. subject is willing and able to comply with all of the testing and requirements defined in the protocol subject, who is a female, must not be pregnant. subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities. subject has a primary diagnosis of adhd. subject has an adult adhd-rs with prompts total score ≥28 at the baseline visit. subject must have a minimum level of intellectual functioning, as determined by the investigator. subject is able to swallow a capsule. subject is currently not on adhd therapy or is not completely satisfied with any aspect of their current adhd therapy. exclusion criteria: subject has a current, comorbid psychiatric diagnosis with significant symptoms. subject is considered a suicide risk in the opinion of the investigator subject has a body mass index (bmi) of \<18.5 kg/m2 at the screening visit. subject has a bmi ≥40 kg/m2 at the screening visit. subject has a concurrent chronic or acute illness, disability, or other condition. subject has a history of seizure, a chronic or current tic disorder, or a current diagnosis of tourette's disorder. subject has a history of moderate to severe hypertension. subject has a known history of symptomatic cardiovascular disease subject has a known family history of sudden cardiac death or ventricular arrhythmia. subject has any clinically significant ecg or clinically significant laboratory abnormality at the screening visit. subject has current abnormal thyroid function subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product. subject has failed to respond, to an adequate course(s) of amphetamine therapy. subject has a history of suspected substance abuse or dependence disorder. subject has a positive urine drug result at the screening visit (with the exception of subject's current stimulant therapy, if any) or subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the screening visit. subject has previously completed, has discontinued, or was withdrawn from this study. subject is taking any medication that is excluded or has not been appropriately washed out according to the protocol requirements. subject is required to take or anticipates the need to take medications that have cns effects or affect performance. subject is female and is pregnant or lactating.
the effectiveness of co-packaging with zinc to improve treatment of diarrhea and pneumonia in guatemala

Conditions: Diarrhea.; Pneumonia.

Summary: this project applies a randomized community design to test the effectiveness of health center level co-packaging and counseling messages to improve provider and caregiver behavior in the treatment of diarrhea with zinc \& oral rehydration salts (ors) and treatment of pneumonia with zinc \& antibiotics in children aged 2-59 mo old. we will evaluate the adherence of caregivers in 10 health posts in 5 municipalities randomly assigned to receive the health center level co-packaging and counseling messages in addition to current standard care, by comparing them with the caregivers in 10 health posts in 5 municipalities randomly assigned to the receive only the current standard of care. cost-effectiveness of co-packaging at the health-center level, as a means of improving provider treatment and counseling practices and caregiver adherence, will be evaluated. the main objective is to establish the effectiveness of a facility level co-packaging and counseling messages for increasing the adherence by caregivers of children aged 2-59 mo old to the prescribed 10 day treatment with zinc to complement ors for the treatment of diarrhea and zinc to complement the antibiotics for the treatment of pneumonia diagnosed and treated in public health posts. specific quantitative objectives: • to determine if visible co-packaging with pre-tested counseling messages: * improves adherence of caregivers of children towards the prescribed zinc treatment. * improves knowledge, awareness or attitudes of caregivers of children and health providers at public health care centers towards the prescribed zinc treatment. * results in overall increase in health care-seeking for the treatment of diarrhea and pneumonia at public health care centers. specific qualitative objectives: * to establish the perception, attitudes and experiences of caregivers towards the visible co-packaging with pre-tested counseling messages to promote the prescribed zinc treatment. * to establish the perception, attitudes and experiences of health providers at public health care centers towards the visible co-packaging with pre-tested counseling messages to promote the prescribed zinc treatment. * to establish the perception, attitudes and experiences of children aged 4 to 5 years old towards the visible co-packaging with pre-tested counseling messages to promote the prescribed zinc treatment.

please note that the study protocol is also available in spanish.

Eligibility criteria:
inclusion criteria: * the child is aged between between 2 and 59 mo old (\< 5 years old). * the child is diagnosed with diarrhea or pneumonia at one of the selected public health care centers. * the caregiver accompanying the child to the public health care centers must live in the same household. exclusion criteria: * unwillingness to sign consent form.

Keywords: diarrhea, pneumonia, zinc treatment, patient compliance.
reminder modality for crc screening

Conditions: Colorectal Cancer

Summary: this is a randomized controlled trial that will evaluate the effectiveness of different reminder modalities for a population-based mailed fit program at the va puget sound among average risk veterans who are due for annual colorectal cancer (crc) screening.

this is a prospective, randomized controlled trial that will evaluate the effectiveness of two different reminder modalities in improving adherence to annual crc screening. veterans eligible for enrollment into the trial will be randomized in a 1:1:1 allocation using permuted block randomization (with random block sizes of 3 and 6) to the following interventions: 1. control arm: no reminder a. intervention type: no intervention 2. arm 2: automated phone reminder a. intervention type: standard reminder via phone (audiocare) 3. arm 3: text reminder a. intervention type: standard reminder via text (vetext) randomization will be stratified within arms by prior screening status (prior screener vs. never screener)

Eligibility criteria:
eligible participants are automatically enrolled in this project. we are unable to enroll participants upon request. inclusion criteria: * veterans assigned to a primary care provider at the va puget sound as of january 1, 2021 * at least 1 year of prior data available (evidence of at least one outpatient visit). * due for annual crc screening exclusion criteria: * not scheduled for either a screening or diagnostic colonoscopy within the following 12 weeks from assessment. * no indication of current receipt of hospice care or record of recent death in the administrative data. * no personal history of crc or history of prior colectomy.

Keywords: cancer screening adherence
helmet cpap vs facemask cpap in acpe (hcpap vs fcpap)

Conditions: Acute Cardiogenic Pulmonary Edema

Summary: this study objectively held to compare the physiological outcomes in the non-invasive (niv) treatment of acute cardiogenic pulmonary edema (acpe) patients in the emergency department (ed) delivered by helmet cpap (hcpap) and facemask cpap (fcpap).patients will be randomized to receive either hcpap or fcpap.

non-invasive ventilation(niv) has different types of interfaces that had been used in acute cardiogenic pulmonary edema. the appropriate interface is necessary to provide comfort and lead to the success of niv. niv delivered via facemask had been used widely. however, it was associated with leaks and discomfort to the patient. helmet continuous positive airway pressure (hcpap) is an niv interface that allows the provision of high airway pressures with a minimal leak.

Eligibility criteria:
inclusion criteria: * all patients aged more than 18 years old presented with acute cardiogenic pulmonary oedema exclusion criteria: 1. age less than 18 years old 2. low gcs (less than 8), altered mental status 3. hemodynamic instability, impending cardiopulmonary arrest 4. use of vasopressors, inotropes 5. exacerbation of asthma or chronic respiratory failure 6. urgent need for endotracheal intubation 7. absence of airway protective gag reflex 8. elevated intracranial pressure 9. tracheostomy 10. pregnant 11. upper airway obstruction 12. injuries or surgery to head and neck less than 6 months upon presentation 13. claustrophobia 14. blind or poor vision 15. medico-legal related cases

Keywords: helmet cpap facemask cpap pulmonary edema non invasive ventilation
growth and plasma amino acids in infants with cmpa and treated with a newly innovated amino acid formula

Conditions: Cow Milk Allergy

Summary: the purpose of this study is to determine growth and protein status of infants with cow's milk protein allergy and treated with a newly innovated amino acid formula compared to those with a commercial amino acid formula.

severe cases of cow's milk protein allergy are treated with the amino acid formula. the amino acid formula is composed of essential and non-essential amino acids, vegetable oils with or without mct oil, and glucose polymer from various carbohydrate sources. such formula is also fortified by minerals, trace elements,and vitamins.

Eligibility criteria:
inclusion criteria: * singleton * clinical diagnosis of cow's milk protein allergy exclusion criteria: * other diseases

Keywords: cow milk allergy amino acid formula
a safety and efficacy study of hospitalized patients with community-acquired pneumonia and sepsis

Conditions: Pneumonia; Sepsis

Summary: the objective of this study is to demonstrate the safety and efficacy of ic14 in the treatment of hospitalized patients with community-acquired pneumonia and sepsis.


Eligibility criteria:
inclusion criteria: * current diagnosis of community-acquired pneumonia. * evidence of systemic inflammatory response to infection. exclusion criteria: * atypical or viral pneumonia based on clinical or epidemiologic suspicion by the investigator. * presence of organ failure.

Keywords: safety and efficacy community-acquired pneumonia, sepsis
clinical application of methylene blue for treatment of covid-19 patients

Conditions: Covid-19

Summary: the severe acute respiratory syndrome caused by covid-19 is now a global catastrophic event. currently there is no approved drug or vaccine for the disease. methylene blue (mb, oxidized form, blue color) has been used in many different areas of clinical medicine, ranging from malaria to orthopedics. leucomethylene blue (reduced form of mb, colorless) may be applied for the treatment of covid-19 according to the scientific evidences.


Eligibility criteria:
inclusion criteria: 1. confirmed case of covid-19 (by rt-pcr, hrct) 2. admission to intensive care unit 3. need for intubation and mechanical ventilation (pao2/fio2 \< 100-200) 4. written informed consent exclusion criteria: 1. pregnancy and breastfeeding 2. history of g6pdh deficiency 3. preadmission anticoagulation 4. severe renal insufficiency (glomerular filtration rate \<30 ml/min/1.73m2) 5. medical records of cirrhosis 6. active chronic hepatitis 7. severe hepatic disease defined by got or gpt levels three times above the normal upper limit 8. patients with history of allergic reaction or significant sensitivity to methylene blue 9. treatment with immunosuppressive agents 10. use of other investigational drugs in the moment of inclusion

Keywords: covid-19 coronavirus
12-month extension study of dialectical behavior therapy for youth with bipolar disorder

Conditions: Bipolar Disorder

Summary: the overarching goal of this project is to evaluate the longer-term effects of implementing dbt for adolescents with bd in a subspecialty clinic. in collaboration with the university of pittsburgh and continuing from the parent study (042-2018), this study will measure the longer-term effects of dbt in additional the the longer-term effects of dbt training on study therapist knowledge and performance.

this is an extension study related to an ongoing implementation study of dialectical behavior therapy (dbt) for adolescents with bipolar disorder, in collaboration with investigators at the university of pittsburgh. during the conduct of that initial study (the dito study; reb pin 042-2018), compelling questions have been raised by the investigators, study therapists, and participants/patients about what will happen following participation in the initial study: which dbt outcomes are sustained over time? will patients request and/or require additional booster sessions? will study therapists remain adherent to the treatment model? there is sparse knowledge regarding what happens after a course of dbt is completed, and this study seeks to advance our understanding of what happens in the year after dbt by addressing these questions. this study provides a unique opportunity to examine the frequency, dose, and indications for ongoing dbt treatment for participants who have completed one year of dbt at the centre for youth bipolar disorder (cybd). in the spirit of the original dissemination and implementation study, this study is focused on "real-world" issues routinely faced by study therapists and patients, and anticipated findings will inform future randomized controlled trials on this topic.

Eligibility criteria:
inclusion criteria: * english-speaking * age 14 years, 0 months to 21 years, 11 months * meet diagnostic criteria for bd by ksads-pl * followed by a camh or sunnybrook psychiatrist who provides ongoing care * if bd-i, taking ≥1 mood stabilizing medication (i.e., antimanic anticonvulsant, antipsychotic, and/or lithium * has completed participation in the dito study (reb pin 042-2018) * able and willing to give informed consent/assent to participate. exclusion criteria: * evidence of mental retardation, moderate to severe pervasive developmental disorder, or organic central nervous system disorder by the k-sads-pl, parent report, medical history, or school records * a life-threatening medical condition requiring immediate treatment * current victim of sexual or physical abuse.

Keywords: dialectical behavior therapy