Kornimate/medical-research-clean huggingface dataset:
evaluating the human immune response to the jynneos vaccine

Conditions: Vaccinia; Virus Diseases

Summary: this study is designed to evaluate the magnitude and duration of the human adaptive immune response to the jynneos modified vaccinia ankara-bavarian nordic (mva-bn) vaccine in the blood, lung mucosa, skin and bone marrow.

orthopoxvirus vaccination leads to very high magnitude antigen-specific t cell responses and neutralizing antibody responses that can be detected in blood decades after vaccination. despite a large number of previous studies of human immune responses to modified vaccinia ankara (mva) vaccination in blood, very few of these previous studies evaluate the human mucosal immune response to mva in the lung and skin, or the immune response to mva vaccination in the bone marrow. the development of methods to explore human immune responses in these key immunologic compartments now allows the evaluation of the induction of immune responses in these human tissues using the mva vaccine system.

Eligibility criteria:
inclusion criteria: * 18-60 year old otherwise healthy participants exclusion criteria: * prisoners * participants unable to provide full written informed consent * previous receipt of a smallpox or monkeypox vaccine * previous infection with monkeypox * receipt of any vaccine in the 28 days prior to the first study procedure or planned receipt of any vaccine outside of those provided in the current study before completion of the study day 42 visit. * immunocompromise (primary or secondary due to other medical conditions or medications) * previous organ transplant * active malignancy * pregnancy * \< 4 weeks post-partum or actively breastfeeding * female participants who are not actively on hormonal contraception or do not have an intrauterine device in place * body mass index \> 40 * current smokers * history of a known chronic pulmonary, cardiovascular, renal, hepatic, hematologic or metabolic disorder. participants with isolated treated hypertension as the only cardiovascular disorder may be included in the study. * history of a chronic neurologic or neurodevelopmental condition. this does not exclude potential participants with chronic back pain or previous disk herniation/back surgery, only participants with documented weakness, quadriplegia or paraplegia. this exclusion criterion also does not exclude from the study participants with recurrent migraine headaches as the only chronic neurologic condition. * pulse oxygen saturation value of 92% or less on room air at study enrollment or on the day of bronchoscopy * any significant infiltrate or pleural effusion on upright posterior-anterior and lateral chest x-ray imaging performed on the day of bronchoscopy * international normalized ratio value greater than 1.4 or a partial thromboplastin time value of greater than 40 seconds at study enrollment * platelet count of less than 100,000 at study enrollment

Keywords: t cell neutralizing antibody mucosal immunity
a trial of positively smoke free group therapy for hiv-infected smokers

Conditions: Tobacco Use in Persons Living With HIV

Summary: the purpose of this study is to determine whether positively smoke free group therapy is more effective at promoting cessation than standard care.

there are 1.1 million persons living with hiv (plwh) in the us, 60% of them smoke cigarettes, and 75% of these are interested in quitting. almost none are currently accessing smoking cessation interventions designed to meet their specific needs and concerns. cigarette smoking is responsible for 24% of deaths among plwh, and 30% of non-aids defining malignancies. it is driving the alarming rise in cardiac events and lung cancers in this highly vulnerable population. the lack of access to proven, effective, culturally appropriate tobacco cessation services represents a health disparity of the first order. the psychosocial profile of the plwh-smoker community, characterized by high rates of psychiatric comorbidity, drug and alcohol use, and low levels of social support, suggests that achieving high cessation rates will be a great challenge. positively smoke free (psf) is an intensive, multisession, group cessation program specifically developed for plwh smokers. a pilot study of psf yielded promising results. this proposal aims (1) to perform a definitive efficacy study of psf by comparing 6-month biochemically confirmed abstinence rates in subjects randomized to psf vs. standard care in a cohort of 450 plwh smokers, (2) to determine the sociobehavioural moderators and mediators associated with successful cessation, and (3) to complete a careful cost analysis of psf in order to estimate the incremental cost per quit associated program participation. if psf is proven to be effective it will establish a new treatment option for plwh smokers. determination of moderators and mediators of program success will provide insight into the mode of action of the intervention and will help guide the development of additional treatment strategies in the future. finally, the cost analyses will provide critical information about the feasibility of program dissemination and implementation.

Eligibility criteria:
inclusion criteria: * hiv-infection * receives care at montefiore medical center or georgetown university * motivated to quit * willing to attend eight 90 minute group sessions exclusion criteria: * pregnancy or breastfeeding * contraindication to nicotine patch use
the effectiveness of coconut oil cream as a prevention treatment for occupational hand dermatitis among batik workers

Conditions: Hand Dermatoses

Summary: empirically, mosturizer is used to prevent and treat many occupational dermatoses that has skin barrier impairment. evidence based medicine about the effectivity of mosturizer in occupational dermatoses is limited. coconut oil is one of traditional substance that is used as a skin care. there is study shows that coconut oil is effective for atopic dermatitis treatment in children. other studies are needed to assess the effectivity coconut oil mosturizer cream to overcome occupational hand dermatitis.

the aim of this study is to measure the effectivenes of coconut oil cream for batik workers who suffer from occupational hand dermatitis. the gloves that used as a protective equipment are made from rubber which have its own limitations. therefore other interventions are needed to improve barrier skin.

Eligibility criteria:
inclusion criteria: * signing the informed consent document before the study start * adult population include patients between the ages of 18 and 64 years who work in the dyeing and washing process more than 6 months. * suffering from occupational hand dermatitis that meet mathias criteria. * willing to obey the research protocol * willing to fill in diary periodically exclusion criteria: * having history of allergy or irritation caused by coconut oil or other mosturizer * suffering from symptoms including edema, exudation, crust, fissures, liver problems, and signs of infection * on corticosteroid treatment ( medium to high potency) or on systemic immunosuppressive therapy
stroke minimization through additive anti-atherosclerotic agents in routine treatment ii study (smaart ii)

Conditions: Stroke; Medication Adherence

Summary: the overall objective of the stroke minimization through additive anti-atherosclerotic agents in routine treatment ii (smaart-ii) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 500 recent stroke patients encountered at 12 hospitals in ghana. secondly, smaart ii seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.


Eligibility criteria:
inclusion criteria: * above the age of 18 years; male or female * ischemic stroke diagnosis no greater than two months before enrollment. ischemic strokes including� lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible * subjects with stroke may present with at least one of the following additional conditions: documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension \>140/90mmhg or previous treatment with antihypertensive medications; mild to moderate renal dysfunction (egfr 60-30ml/min/1.73m2); prior myocardial infarction * legally competent to sign informed consent. exclusion criteria: * unable to sign informed consent * contraindications to any of the components of the polypill * hemorrhagic stroke * severe cognitive impairment/dementia or severe global disability limiting the capacity of self-care * severe congestive cardiac failure (nyha iii-iv) * severe renal disease, egfr \<30ml/min/1.73m2), renal dialysis; awaiting renal transplant or transplant recipient * cancer diagnosis or treatment in past 2 years * need for oral anticoagulation at the time of randomization or planned in the future months; * significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation) * nursing/pregnant mothers * do not agree to the filing, forwarding and use of his/her pseudonymized data.
improving depression via e-health access (idea) study

Conditions: Depression

Summary: the researchers are doing this study to learn more about which online self-help resources, including a smartphone app, an online program, or an informational website, primary care patients with depression are likely to choose and whether the chosen tool will improve their depressive symptoms and wellbeing. the researchers would also like to know how likely someone is to use the resources and their satisfaction with the resources.

participants will be using a self-help resource for the 6-week study period. a care manager will contact participants by phone, once a week, for about 5-10 minutes at a pre-arranged time. participation will be needed for 10 weeks in total (6 weeks of active participation and a survey 1-month after the study intervention ends). subscription-based self-help resources being tested during the study will not be freely available after the study period. however, the researchers will share information on how to access these resources for a fee after the study period to all participants. in addition to the time above, the researchers will collect information from participant's medical records for another 10 months after participation. the entire study is expected to last about 2 years.

Eligibility criteria:
inclusion criteria: * individuals who are english-speaking * individuals with a patient health questionnaire 9 (phq9) score greater than or equal to 11 or diagnosis of moderate to severe depression determined by the care manager during her initial psychiatric evaluation and by the study pi during panel review will supersede a low phq9 score. * individuals with have daily internet access and a smartphone; * individuals who agree to periodic contact with the care manager and study team. exclusion criteria: * individuals who have cognitive impairment that would preclude use of self-help resources * individuals with already using an electronic mental health resource; * individuals with unstable medical illness, e.g. active cancer; * individuals with severe psychiatric symptoms (marked suicidality, psychotic symptoms, severe substance abuse)
ctcs and novel target bio-marker analysis for prediction and monitoring of metastasis/recurrence in post-surgery colorectal cancer patients using miselect r rare cell system

Conditions: Circulating Tumor Cells, CTC

Summary: despite the growing public awareness and recent progress in multimodality therapy to the colorectal cancer (crc), crc still ranks high on the list of the most common and deadly cancers in taiwan. the cause of crc mortality is due mainly to the occurrence of distant metastasis. several reports suggested that circulating tumor cells (ctcs) highly associated with metastasis suggesting that targeting ctcs may offer an unprecedented opportunity to prevent the development of metastasis. early detection and characterization of ctcs is therefore important as a potential strategy to monitor the progression of crc. the current proposal is focused on detecting ctcs from peripheral blood of crc patients using miselect r system. we will monitor the amount of ctcs and correlate with crc progression and prognosis.


Eligibility criteria:
inclusion criteria: 1. over 20 and less than 90 years of age. 2. colorectal cancer stage ii/iii patients who will undergo surgical resection. 3. subject having agreed to participate in the study and follow the study procedures by providing written informed consent prior entering the study. exclusion criteria: 1. have other cancer history. 2. subject being identified with any blood borne infectious disease
dexmedetomidine infusion versus oral melatonin for prevention of intensive care delirium

Conditions: Dexmedetomidine; Melatonin; Delirium

Summary: this study aims to compare the effect of dexmedetomidine infusion and oral melatonin on preventing delirium in intensive care unit (icu) patients.

delirium is experienced in 20% to 40% of the critically ill and up to 80% of mechanically ventilated (mv) medical or surgical patients . it is a confessional state that has been described as a transient global disorder of cognition, awareness, and attention and as such is not only challenging for the treating medical team, but also has a considerable impact on affected patients. it is associated with prolonged hospital length of stay and time on mv, deterioration in cognition, and increased morbidity and mortality causing additional health-care expenses.

Eligibility criteria:
inclusion criteria: * patients aged 21 years or older. * either gender. * healthy gastrointestinal function (patients tolerated oral medications by gavage or mouth). * richmond agitation sedation scale (rass) \>-1. * no basic delirium or mood changes before admission to intensive care unit(icu). exclusion criteria: * patient refusal. * history of irreversible brain disease consistent with severe dementia. * patient admitted with a primary neurologic condition or injury (e.g., intracranial hemorrhage). * heart rate (hr) less than 50 beats/ min or second- third degree heart block in the absence of a pacemaker. * acute alcohol withdrawal requiring benzodiazepine administration. * history of hepatic encephalopathy or end-stage liver disease (child-pugh class b or c). * the expected duration of intensive care unit (icu) stay less than 5 days. * inability to obtain informed consent. * pregnancy. * allergy to dexmedetomidine or melatonin.
airway inflammation in children with allergic rhinitis and intervention

Conditions: Allergic Rhinitis; Inflammation; Respiratory Tract Diseases; Hypersensitivity

Summary: the purpose of this study is to determine whether treating upper airway with intranasal corticosteroids in children with allergic rhinitis and no asthma may bring favors in reducing lower airway inflammation and improving small airway function.

type of study : this is a prospective randomized,double-blind, placebo-controlled study , to clarity whether treating upper airway with intranasal corticosteroids in children with allergic rhinitis may bring favors in reducing elevated lower airway inflammation，improving airway reactivity and airway resistance. methods : the children with allergic rhinitis accompanied lower airway inflammation such as elevated percentage of eosinophil in induced sputums and/or higher level of fractional exhaled nitric oxide(feno) are recruited.by using a random digit table, eligible subjects were randomized into one of two groups,to receive budesonide nasal spray (bud group) or nasal placebo(placebo group), 1 spray/nostril, 2 times/day, for three consecutive months observation. the following measurements were performed: skin prick test (spt), peripheral blood cells five-classification test, serum total immunoglobulin e (ige) and specific ige of common inhalant allergens testing, nasal lavage and inflammatory cells classification ，pulmonary function test, bronchial provocation test，airway resistance measured by impulse oscillation technique. meanwhile,history of all subjects were collected, visual analogue scale，rhinitis symptoms scores and rhinoconjunctivitis quality of life questionnaire (rqlq) scores were evaluated. symptom scores and laboratory examinations are performed at baseline,4 w,8w and 12 w after treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of allergic rhinitis without asthma * sensitized to more than 1 common aeroaller¬gens * feno \>20ppb and/or induced sputum eosinophil\>2.5% exclusion criteria: * respiratory infection 2 weeks prior to initial visit * children with nasal polyposis * history of immunotherapy * unable to complete the test or had limited understanding * use of systemic corticosteroids 4 weeks prior to initial visit * nasal and inhaled corticosteroids 2 weeks prior to initial visit * leukotriene receptor antagonists 2 weeks prior to initial visit * use of antihistamines 7 days prior to initial visit

Keywords: allergic rhinitis；airway inflammation；hyperreactivity
eap_gs010_single patient

Conditions: Leber Hereditary Optic Neuropathy (Optic, Atrophy, Hereditary, Leber)

Summary: expanded access use for a single patient of bilateral intravitreal injection of gs010 in a single subject affected with g11778a nd4 leber hereditary optic neuropathy


Eligibility criteria:
the eap applies to patients not eligible to ongoing gs010 clinical trials. inclusion criteria: * presence of documented g11778a nd4 lhon-causing mutation * signature of informed consent and assent from the parent/guardian and the patient. exclusion criteria: contraindications to gs010 product or ivt procedures are to be checked prior to consent signature and treatment injection: * any known allergy or hypersensitivity to gs010 or its constituents. * contraindication to intravitreal injection in any eye. * intravitreal drug delivery to any eye within 30 days prior to the injection * previous vitrectomy in either eye. * narrow angle in any eye contra-indicating pupillary dilation. * presence of disorders or diseases of the eye or adnexa, excluding lhon, which may interfere with visual or ocular assessments, including sd-oct, during the study period. * presence of known/documented mutations, other than the g11778a nd4 lhon-causing mutation, which are known to cause pathology of the optic nerve, retina or afferent visual system. * presence of systemic or ocular/vision diseases, disorders or pathologies, other than lhon, known to cause or be associated with vision loss, or whose associated treatment(s) or therapy(ies) is/are known to cause or be associated with vision loss. * presence of optic neuropathy from any cause except lhon. * presence of illness or disease that, in the opinion of the investigator, include symptoms and/or the associated treatments that can alter visual function, for instance cancers or pathology of the central nervous system, including multiple sclerosis (diagnosis of multiple sclerosis must be based on the 2010 revisions to the mcdonald criteria \[polman 2011\]). * history of recurrent uveitis (idiopathic or immune-related) or active ocular inflammation. * previous treatment with ocular gene therapy in either eye. * subjects who have undergone ocular surgery of clinical relevance (per investigator assessment) within 90 days prior to injection. * subjects who are unable to tolerate (e.g. the immune modulating regimen) or unable or unwilling to comply with all the protocol requirements.

Keywords: heredity optic atrophy leber hereditary optic atrophy leber hereditary optic neuropathy lhon eye diseases hereditary eye diseases inherited retinal dystrophies or degeneration inborn genetic disease gene therapy intravitreal injections mitochondrial disease aav2 vectors neurodegenerative disease atrophy
mobile behavior change program for weight loss in breast cancer survivors

Conditions: Weight Loss; Behavior, Health

Summary: the purpose of this study is to evaluate the preliminary efficacy of a noom breast cancer weight loss program on weight loss outcomes, quality of life, and physical activity. also, to qualitatively determine acceptability of this novel program among breast cancer survivors with overweight or obesity.


Eligibility criteria:
inclusion criteria: * able to understand and provide informed consent * 18 years and older * overweight or obesity (bmi ≥ 27.5) * not 6 months postpartum * not planning to become pregnant in the next 7 months * have a smartphone that is compatible with noom's mobile app * breast cancer survivor with stage i, ii, or iii * completed active treatment (e.g, surgery, chemo, radiation, etc.) \> 6 months ago exclusion criteria: * inability or unwillingness of a participant to give written informed consent * currently pregnant or \< 6 months postpartum * plans to become pregnant within the next 7 months * stage iv, metastatic cancer or dcis * currently taking insulin * uncontrolled hypertension
long-term results after intravitreal bevacizumab treatment of neovascular age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: 200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (bcva) will be measured using snellen charts at 6m. central retinal thickness (crt) will be measured using stratus oct and cirrus sd-oct (zeiss). data of treatment-naive eyes (group 1) were compared to the data of eyes that had undergone prior treatment with photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).

in this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. data of treatment-naive eyes (group 1, n = 114) were analyzed separately from eyes that had undergone previous photodynamic therapy plus intravitreal triamcinolone (group 2, n = 67). re-treatment criteria were based on clinical outcome following the official european label regimen. after 1 year of continuous service at an academic referral center, follow-up was performed in private practices in collaboration with the referral center. main outcome parameters were best-corrected visual acuity and central retinal thickness.

Eligibility criteria:
inclusion criteria: * any subtype of neovascular age-related macular degeneration * age of 50 years or older * initial treatment with intravitreal bevacizumab between august 2005 and june 2006 exclusion criteria: * previous vitrectomy * presence of cystoid macular edema without choroidal neovascularization * uncontrolled systemic disease

Keywords: bevacizumab, choroidal neovascularization