Kornimate/medical-research-clean huggingface dataset:
long-term study of advm-022 in neovascular (wet) amd [optic-ext]

Conditions: Wet Age-related Macular Degeneration; Neovascular Age-related Macular Degeneration

Summary: advm-022-07 is an observational long-term extension (optic-ext) study assessing safety and efficacy of advm-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (namd).

advm-022 (aav.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet amd). wet amd is a serious condition and the leading cause of blindness in the elderly. the available therapies for treating wet amd require life-long intravitreal (ivt) injections every 4-12 weeks to maintain efficacy. a one-time ivt administration of advm-022 has the potential to treat wet amd by providing durable expression of therapeutic levels of intraocular anti-vegf protein (aflibercept) and maintaining the vision of patients. advm-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet amd receiving anti-vegf therapy in clinical practice. advm-022-07 is an observational long-term extension (optic-ext) study assessing safety and efficacy of advm-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (namd). to evaluate potential long-term outcomes of advm-022, the optic-ext will follow subjects previously treated in the optic parent study (clinical protocol no. advm-022-01 \[optic\] (nct03748784)). subjects will roll over from the optic parent study and will be followed for 3 additional years, following completion of the preceding 2-year assessment period in the optic parent study. there is no investigational treatment administered in this study.

Eligibility criteria:
inclusion criteria: * subjects who received a single dose of advm-022 at any dose in the optic study * willing and able to provide informed consent exclusion criteria: * none

Keywords: choroidal neovascularization advm-022 optic study cnv advm-022-01 advm-022-07 aav.7m8 anti-vegf therapy blindness gene therapy aflibercept (eylea) age-related macular degeneration wet macular degeneration retinal degeneration retinal diseases eye diseases aav vector adverum wamd amd wet amd namd optic extension optic-ext long-term follow up long-term extension
expanded access of ruxolitinib cream to treat a single patient with cgvhd

Conditions: Graft-versus-host Disease (GVHD)

Summary: to provide ruxolitinib through an expanded access to treat a single patient with cgvhd


Eligibility criteria:

Keywords: ruxolitinib acute or chronic steroid-refractory gvhd hematopoietic stem cell transplantation (allo-hsct)
neurobiological aspects of the attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: evaluating neurobiological disorder associated with attention deficit hyperactivity disorder (adhd) and the contribution of transcranial direct current stimulation (tdcs) in the adaptation of inhibitory control.

1. assess the neurobiological aspects evidenced by the amount of brain electrical activity observed by the amplitude of waves through graphs in patients with adhd, using quantitative electroencephalography; 2. study the contribution of transcranial direct current stimulation compared with sham in the adequacy of inhibitory control in adhd patients through neuropsychological test-go/no go; 3. assessing the efficacy of tdcs in neurobiological parameters evidenced by quantitative eeg in patients with adhd; 4. perform the reconstruction of the functional brain network of each subject based on the quantitative eeg data through computational and mathematical modeling; 5. register indicators of quality of life in adults with attention deficit hyperactivity disorder through the quality of life questionnaire for adults with adhd (aaqol).

Eligibility criteria:
inclusion criteria: * signature of the informed consent; * diagnosis of attention deficit hyperactivity disorder based on dsm-iv-tr and adult self-report scale (asrs-18); * adequate eyesight and hearing (or usual corrective methods such as glasses or hearing aid) that allows performing neuropsychological test and questionnaires; * residents in bahia/brazil; * over 18 years. exclusion criteria: * major psychiatric disorders such as schizophrenia and bipolar disorder; * inability to understand the questionnaires used or illiterate; * abuse of psychoactive substances, except nicotine and caffeine, in the last 12 months.

Keywords: attention deficit hyperactivity disorder (adhd); transcranial direct current stimulation (tdcs); control inhibitory; quantitative electroencephalography; functional brain network; go/no go test.
ticagrelor versus clopidogrel in myocardial salvage in patients with stemi undergoing primary pci

Conditions: Acute Coronary Syndrome

Summary: therefore, in this study, we try to evaluate the impact of clopidogrel loading dose 300mg vs. ticagrelor 180 mg on myocardial injury as measured by contrast-enhanced magnetic resonance imaging (ce-mri) in stemi patients undergoing primary pci.

all stemi patients will be loaded with dual oral antiplatelet therapy of 300 mg aspirin combined with either 300 mg clopidogrel or 180 mg ticagrelor before pci, followed by maintenance dose of 100 mg aspirin plus 75 mg clopidogrel qd or 90 mg ticagrelor bid. the duty interventional cardiologists will be responsible for patient randomization based on a pre-defined randomization chart. as it is a usual practice in taiwan for door-to-balloon time to be within 90 minutes, we hence do not expect any impact on study results due to d2b time variation. all stemi patients will receive loading dose of dual oral antiplatelet therapy with 300 mg aspirin combined with either 300 mg clopidogrel or 180 mg ticagrelor before pci, followed by maintenance dose of 100 mg aspirin plus 75 mg clopidogrel qd or 90 mg ticagrelor bid. the primary variable is to compare myocardial salvage index (in %) as assessed by ce-mri between 300-mg clopidogrel group and ticargrelor group. enzymatic infarct size will also be assessed, and two methods will be used to decide that. the first is cardiac troponini 72 hours after pain onset , while the other is peak ck level after pain onset. sampling timing of ck will be judged by the caring physicians. the secondary objectives include: myocardial infarct size (% of lv mass), the extent of mvo, the number of segments with \>75% of infarct transmurality.

Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures 2. adult patients aged 20 years or older 3. stemi within 12 hours of onset, defined as:presence of chest pain for \>30 minutes and \ 1 mm in ≥2 contiguous leads or presumably a new-onset left bundle-branch block on electrocardiogram. 4. stemi patients planned for ppci exclusion criteria: 1. stemi \> 12 h of onset 2. history of renal dysfunction requiring dialysis 3. evidence of malignant diseases 4. unwillingness to give out consent 5. contraindicated for ticagrelor or clopidogrel

Keywords: acute myocardial infarction antiplatelet agents magnetic resonance imaging (mri)
ai detection of incidental coronary artery calcium to enhance cardiovascular disease prevention

Conditions: Coronary Artery Disease

Summary: ai inform is a multicenter randomized trial that will test the hypothesis that providing clinicians information on the presence and amount of coronary artery calcifications (cac), will result in initiation or intensification of preventive therapies. the study will use a cloud-based artificial intelligence (ai) platform (nanox.ai) that can analyze non contrast chest ct and estimate the amount of cac.


Eligibility criteria:
inclusion criteria: * patients aged between 40-75 with prior chest ct within last 3 years exclusion criteria: * prior coronary artery disease * prior cancer * other life-limiting condition
a feasibility study using the coronacheck device to identify incident cases of sars cov-2 covid-19

Conditions: SARS-CoV Infection

Summary: point of care testing is urgently required to enable the immediate detection of sars-cov-2 infection to allow effective transmission prevention precautions to succeed.

the coronacheck device is a hand-held, portable, point-of-care device which will allow the safe collection of ebc. it provides an automated platform for the detection of sars-cov-2 using an existing sensor repurposed with immobilised recombinant ace-2 to bind the virus. this produces a measurable signal indicating whether sars-cov-2 is present or not. ebc is collected by the coronacheck device during tidal breathing, making this investigation non-invasive, repeatable and easy to perform. previous studies using inflammacheck™ in people with respiratory conditions have shown it is well tolerated, even in people with severe lung disease. the full test cycle including sample collection and test assay typically occurs in less than 5 minutes. given the risk of infection, this coronacheck™ device has an integrated sensor and breath collection system combined in a fully enclosed, disposable unit to mitigate the risk of cross-infections between users and also reduces any exposure risk to healthcare staff. it is appreciated that disposable plastic has a negative environmental impact, however due to the highly contagious nature of sars-cov-2 it is felt unavoidable at present. using the coronacheck does not require laboratory equipment or expertise, and is a quick, easy-to-use point-of-care investigation which provides an immediate result. this could potentially be applied to screening for sars-cov-2 in a wide variety of environments for example: gp practices, drive-thru centres, colleges, universities, airports and sports arenas. any person undergoing a swab for a possible sars cov-2 infection is eligible for inclusion, participants will not be assigned an intervention. the participants will breathe into the coronacheck device. this involves breathing for up to 6 minutes into a single use, fully sealed unit attached to the hand-held device. this disposable unit has a bacterial-viral filter attached to both the breathing inlet and the exhale outlet to eliminate any risk of contamination. the coronacheck device then provides a reading reflecting ebc ace2 binding which will be documented on the ecrf. this result will not be recorded in the clinical notes as it is not intended to inform patient management decisions in this study.

Eligibility criteria:
inclusion criteria: o any adult (≥ 16 years of age) who is: * undergoing a swab for possible sars-cov-2 infection * willing and able to give informed consent for participation in the study * unlikely to suffer harm as a result of testing in the opinion of the investigator exclusion criteria: o participants receiving: * invasive ventilation, non-invasive ventilation or nasal high flow oxygen * supplementary oxygen with symptomatic hypoxia or oxygen saturations ≤92% (≤88% in copd) despite 4l oxygen via nasal cannulae * unable to comprehend the study or provide informed consent
intravitreal bevacizumab for polypoidal choroidal vasculopathy

Conditions: Polypoidal Choroidal Vasculopathy

Summary: 1. primary objectives a. to evaluate the effects of intravitreal bevacizumab on polypoidal choroidal vasculopathy(pcv) 2. secondary objectives 1. to assess the changes in visual acuity 2. to assess the change in lesion characteristics of pcv * size of pcv * fluorescein leakage * foveal thickness 3. to investigate the safety of intravitreal bevacizumab in patients with pcv 4. to assess the effect of intravitreal bevacizumab on the recurrence rate and the the incidence of submacular hemorrhage in patients with pcv


Eligibility criteria:
inclusion criteria: * male or female, cnv secondary to pcv * bcva of 20/40 to 20/320 (snellen equivalent) * evidence of presumed recent disease progression (blood, growth by fa, or recent va loss) exclusion criteria: * uncontrolled glaucoma or any other ocular condition that would prevent an improvement in visual acuity * media opacity in the study eye that precludes clinical and photographic evaluation * intraocular surgery \< 1 month before day 0 * use of heparin/warfarin within 1 month prior to injection * known allergy or hypersensitivity to fluorescein, indocyanine green or povidone iodine * contraindication to pupil dilation in either eye * any condition which precludes patients' ability to comply with study requirements including completion of the study

Keywords: polypoidal choroidal vasculopathy intravitreal bevacizumab
health-related quality of life and long covid

Conditions: Long COVID

Summary: background: long covid is estimated to affect 1.7 million people in the uk. one way of assessing the impact of long covid is to measure quality-of-life through a standard questionnaire, which can then be used to understand the costs of long covid to the nhs and wider economy. the impact of long covid on these measures is not currently known. it is important to understand who is worst affected by long covid and the cost to the national health service (nhs), so that strategies like booster vaccines can be prioritised to the right people. aim: openprompt aims to understand the impact of long covid on quality-of-life in adults in english primary care. methods: we will ask people to participate in the study by downloading a smartphone app, and completing a series of questionnaires held within the app. questionnaires will ask about quality of life, productivity and symptoms of long covid. participants will be asked to fill in the questionnaires once a month, for four months. electronic reminders will be sent to participants to ask them to complete the questionnaires, which will take roughly 15 minutes to complete each month. participants will also be asked to give consent for linkage of their questionnaire responses to their existing health records. the results will tell us if long covid has different quality-of-life and economic impacts among people of different ages, ethnicities, geographic regions, or because of any underlying health conditions. these results can be converted into standardised measurements used by the nhs to measure the impact of illnesses and the cost of long covid to health services. impact: together with other researchers studying long covid, we will provide results to support long-term care, and make recommendations for prevention of long covid in the future. at all stages we will ensure that the input of patients and the public is central to running the study and interpreting the outputs. funding: openprompt is a collaboration between the london school of hygiene and tropical medicine, the opensafely patient data platform at the university of oxford, and tpp (which supplies clinical software to general practices (gps) in the uk). the project is funded by the national institute for health research.


Eligibility criteria:
inclusion criteria: * inclusion criteria are that the patient is aged 18 or over and can read and understand english, and can download and use the airmid app. exclusion criteria: * the following patients will be excluded: * patients under 18 years old; * patients who do not have a smartphone or cannot download or log in to the airmid app; * patients who cannot understand english.
evaluation of very low nicotine content cigarettes in adolescent smokers

Conditions: Nicotine Dependence

Summary: the purpose of this study is to determine how reducing the level of nicotine in cigarettes may affect adolescent smoking behavior. in this study, the researchers will randomize adolescent (age 15-19) daily smokers to either receive vlnc cigarettes or normal-nicotine content (nnc) study cigarettes for three weeks following a one-week usual-brand baseline period. participants will be instructed to smoke only those cigarettes. the researchers will conduct daily assessments of total cigarette use (both study cigarette and non-compliant use of usual brand cigarettes), craving, and withdrawal, weekly assessments of breath carbon monoxide (co) levels, cigarette acceptability, risk perceptions of vlnc and nnc cigarettes and demand for usual-brand cigarettes, and pre- vs. post-use measures of nicotine and toxicant exposure. overall, the project will help determine how vlnc cigarettes may affect real-world smoking behavior in adolescents, and illuminate the potential mechanisms through which these products may effect such changes. such knowledge will contribute to the science base that may inform future policy decisions.


Eligibility criteria:
inclusion criteria: * current daily smoking (1 or more cigarettes per day for the past 6 months or longer). participants must meet a breath carbon monoxide criterion of 6 ppm or higher; if this is not met, urine cotinine levels, detected by a nicalert cotinine screening device, must indicate recent smoking (level 3 or higher). * participants must speak and comprehend english well enough to complete study procedures. exclusion criteria: * current pregnancy * self-reported daily use of alcohol or other non-prescribed drugs (excluding marijuana). * participants who are seeking treatment for their smoking or who report that they intend to quit smoking within the next 30 days and have made a 24-hour quit attempt in the past year * participants who report current suicidal ideation on the mini suicide subscale questions 4 \& 5 ("in the past month did you have a suicide plan?" and "in the past month did you attempt suicide?"), as well as participants who indicate that they have made a suicide attempt in their lifetime * participants who report use of other non-cigarette tobacco products more than 9 out of the last 30 days
safety of nasal influenza immunisation in egg allergic children - the sniffle 2 study

Conditions: Egg Hypersensitivity

Summary: egg allergy is common in early childhood, affecting at least one in 50 preschool children. influenza ("'flu") vaccines contain egg protein, as the vaccine is cultured in hen's eggs. there is robust data to support the safety of influenza vaccines (containing low or negligible amounts of egg protein) in patients with egg allergy. a new influenza vaccine, known as laiv (live attenuated intranasal vaccine) has recently been approved by a number of licensing boards and is given by a spray into the nose. this new vaccine has been available in the united states for several years and is highly effective and against influenza infection, with an excellent safety profile in children without egg allergy. however, laiv is also grown in hen's eggs and contains egg protein, and there are no published data on the safety of laiv in egg-allergic children. in sniffle 1 study, 433 doses were given to 282 egg-allergic children; data is currently being analysed. the objective of this multicentre study is to further assess the safety of intranasal laiv in egg-allergic children, in order to demonstrate that these children can safely be given the new laiv within a primary care health environment.


Eligibility criteria:
inclusion criteria: * aged 2 - 17 years old * physician-diagnosis of egg allergy exclusion criteria: 1. clinical resolution of egg allergy 2. contraindications to laiv (notwithstanding allergy to egg protein): * hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue) * previous systemic allergic reaction to laiv * previous allergic reaction to an influenza vaccine (not laiv) is a relative contra-indication, which must be discussed with the site pi to confirm patient suitability * children/adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic hiv infection; cellular immune deficiencies; and high-dose corticosteroids. nb: laiv is not contraindicated for use in individuals with asymptomatic hiv infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency. * children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of reye's syndrome with salicylates and wild-type influenza infection. 3. contraindication to vaccination on that occasion, due to child being acutely unwell: * febrile ≥38.0oc in last 72 hours * acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional * recent admission to hospital in last 2 weeks for acute asthma * current oral steroid for asthma exacerbation or course completed within last 2 weeks
use of indocyanine green cholangiography and methylene blue to detect postoperative biliary fistula after hepatectomy

Conditions: Liver Disease

Summary: the aim of the present study is to evaluate whether the use of indocyanine green fluorescent cholangiography is responsible in a decrease of biliary fistula's rate in patients with liver diseases requiring liver resection.


Eligibility criteria:
inclusion criteria: * benin or malignant liver disease with resection of 2 or more segments * liver resection by laparotomy * written consent exclusion criteria: * previous hepatectomy * emergency surgery * allergy to indocyanine green * allergy to methylene blue * pregnancy or breastfeeding

Keywords: per operative cholangiography liver resection biliary fistula
hipec and systemic chemotherapy in unresectable peritoneal metastases from colorectal cancer

Conditions: Peritoneal Metastases From Colorectal Cancer

Summary: the prognosis of patients with unresectable peritoneal metastases from colorectal cancer is poor. these patients may obtain survival benefit from radical colorectal resection and cytoreductive surgery (crs). the response rates of previous conversion therapy are low. hyperthermic intraperitoneal chemoperfusion (hipec) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (pci) levels. the purpose of this study is to investigate the efficacy and safety of hipec and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer.

to determine the efficacy and safety of hipec and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer, patients undergo hipec with raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week oxaliplatin/capecitabine chemotherapy. the second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.

Eligibility criteria:
inclusion criteria: * histological proved diagnosis of colorectal cancer. * unresectable peritoneal metastases and primary tumor proved at surgery. * no evidence of distant metastases. * have not received radiotherapy, chemotherapy or immunotherapy. * ecog score: 0\~2. * written informed consent is obtained prior to commencement of trial treatment. exclusion criteria: * existence of distant metastasis outside the abdomen. * any previous radiotherapy, chemotherapy or immunotherapy. * active systemic infections. * inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. * female patients who are pregnant or breast feeding