Kornimate/medical-research-clean huggingface dataset:
enb and photodynamic therapy in the treatment for early lung cancer

Conditions: Lung Cancer

Summary: with the increased incidence of lung cancer and prevalence of low dose ct screening, treating of early lung cancer has becoming an important issue in the clinical practice of thoracic oncology. in this clinical study, the investigators will evaluate whether superdimension (superd) enb (electromagnetic navigation bronchoscopy) in combination with interstitial photodynamic therapy can provide the chance of tumor eradication.

lung cancer is the one the major cause of cancer death all over the world especially in asia. the prevalence of low dose ct screening has made more patients of lung cancer treated in the early stage. the treatment of choice for of early lung cancer is surgical resection. however, several difficulties exist in surgery for treating early lung cancer. eg. some presenting as multi-focal lesions, which cannot be completely eradicated by surgical resection. electromagnetic navigation bronchoscopy (enb)（superdimension™ navigation system, super-d enb) is a novel technique, which uses an image guided localization system to direct steerable bronchoscopic tools to predetermined points within the bronchial tree. this technology allows improved access to peripheral lesions in particular. photodynamic therapy (pdt) has been adopted an effective treatment option for the central located lung cancer by using photosensitizer which is focally retained in the tumor leading to tumor-specific abrasion by irradiating with a certain wave-length of light. the most frequently used and commercially available photosensitizer for lung cancer is pdt with photofrin under 623 nm red light irradiation. for the peripheral lung cancer which cannot be approached by bronchoscopy, interstitial pdt with the aids of ct guided catheter implantation has been adopted. however, there are potential disadvantages of such approach including 1) bleeding or hemothorax during ct-guided catheter implantation; 2) dislodging of the catheter after lung collapse in the procedure; 3) unable to treat other lesion after pneumothorax. in the current proposal, the investigators use enb in combination with pdt to handle to test the feasibility of super-d enb guided-pdt to treat small lung cancer which cannot be eradicated through surgical resection.

Eligibility criteria:
inclusion criteria: 1. multiple small lung cancer which cannot be completely removed by surgical resection. 2. patient with small early lung cancer with diameter less than 1 cm and with high surgical risk precluding surgery. 3. patient with small early lung cancer with diameter less than 1 cm but unwilling to receive surgical intervention. 4. age above 20 years old and who can do the bronchoscopy test exclusion criteria: 1. bleeding tendency. 2 .poor cardiopulmonary function with intolerance to bronchoscopy examination.

Keywords: early lung cancer photodynamic therapy enb
preselection of patients at risk for cognitive decline after radiotherapy using advanced mri

Conditions: Meningioma

Summary: meningioma are slow growing and frequently occurring intracranial tumors, responsible for 33% of all asymptomatic intracranial tumors and 13-26% of all symptomatic primary brain tumors. the 10-year survival rate is 72%. a variety of treatment options is available for symptomatic meningioma including surgical removal with or without radiotherapy or radiotherapy alone. these therapies can have negative impact on cerebral functioning. after high dose radiotherapy for primary or metastatic brain tumors 50-90% of \> 6 months' survivors develop irreversible disabling cognitive decline leading to premature loss of independence, reduced quality of life (qol) as well as significant economic burden both at the individual as societal level. especially for patients with a good prognosis like benign meningioma, maintaining neurocognitive function is crucial. understanding the mechanisms underlying radiation induced cognitive decline is complex and which brain areas to spare are an important subject of research. evaluation methods to assess cognitive function and predict cognitive decline are urgently needed, this will allow the development of optimized treatment strategies with the aim to preserve or even improve cognitive function in meningioma patients. improvements in the field of neuroimaging techniques (i.e. advanced mri techniques) have the possibility to identify areas susceptible to cognitive impairment. this allows in the future a more personalized radiation treatment by identifying patients at risk, by optimizing the radiotherapy dose to specific brain regions, that could eventually reduce or prevent, cognitive decline. improvements in the field of radiotherapy for example by higher precision treatment such proton therapy have potential in obtaining these more individualized strategies.


Eligibility criteria:
inclusion criteria: * meningioma who i, grading based on pathology or radiological features * age ≥ 18 years. * karnofsky performance score 70 or above. * ability to comply with the protocol, including neuropsychological testing and imaging. * ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician. * written informed consent. exclusion criteria: * resection meningioma \< 3mnd * age \< 18 years * pregnancy * any prior cranial radiotherapy * any prior chemotherapy in the last 5 years * contra-indication for mr imaging (i.e. metal implants, claustrophobia) * any other serious medical condition that could interfere with follow-up. * severe aphasia or language barrier interfering with assessing endpoints (i.e. completion of questionnaires or neurocognitive performance)

Keywords: meningioma radiotherapy mri neurocognition
improve-it: examining outcomes in subjects with acute coronary syndrome: vytorin (ezetimibe/simvastatin) vs simvastatin (p04103)

Conditions: Hypercholesterolemia; Myocardial Infarction

Summary: this is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (acs). the primary objective is to evaluate the clinical benefit of ezetimibe/simvastatin combination 10/40 (single tablet, under the brand vytorin in the united states) compared with simvastatin 40 mg. as per the original protocol, if low-density lipoprotein cholesterol (ldl-c) response was inadequate, the dose of simvastatin in the vytorin arm or simvastatin arm, could be increased to 80 mg (note: per june 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (cv) death, major coronary events, and stroke.


Eligibility criteria:
inclusion criteria: * clinically stable participants may be eligible to enroll within 10 days following hospital admission with high-risk acute coronary syndrome (either st-elevation myocardial infarction \[stemi\] or non-stemi or unstable angina) * participants not taking a statin must have an ldl-c of 125 mg/dl or less. participants taking a statin must have an ldl-c of 100 mg/dl or less. exclusion criteria: * pregnant or lactating woman, or intending to become pregnant * participant with active liver disease or persistent unexplained serum transaminase elevation * history of alcohol or drug abuse * history of sensitivity to statin or ezetimibe * a participant for whom discontinuation of existing lipid lowering regimen poses an unacceptable risk.

Keywords: hypercholesterolemia myocardial infarction cholesterol randomized controlled trials acute coronary syndrome angina
effect of melatonin on multiple sclerosis related fatigue

Conditions: Fatigue

Summary: the purpose of this study was to evaluate the efficacy and safety of melatonin in treatment of fatigue and quality of life of ms patients.

multiple sclerosis (ms) is one of the most common non-traumatic causes of disability in the world. it is a chronic inflammatory and demyelinating disorder of the central nervous system (cns) which affects individuals in the productive ages and causes a large burden for years to come. fatigue is a common complaint and one of the least understood symptoms of ms

Eligibility criteria:
inclusion criteria: 1. definite diagnosis of relapsing-remitting ms (rrms) by the macdonald criteria 2. a baseline of expanded disability status score (edss)of less than 5.0 3. aged between 18 and 55 years of either sex 4. treated with one type of interferon beta-1a (ifnb-1a); 5. signed an informed consent exclusion criteria: 1. clinical relapsing of ms during past 30 days; 2. use of melatonin and warfarin within 30 days prior to participation; 3. concomitant use of beta-blockers, anti-diabetic agents, antiplatelet agents, nsaids, aspirin ; 4. working more than one nighttime shift per month; 5. pregnancy or lactation; 6. history of a chronic hematological, cardiac, hepatic, renal or thyroid disorders ; 7. failure to adhere to the study protocol

Keywords: multiple sclerosis melatonin fatigue quality of life
corneal crosslinking for treatment of corneal neovascularization

Conditions: Corneal Neovascularization

Summary: the study objective is to assess safety and efficacy of photo-activation of riboflavin for treatment of corneal neovascularization with or without concomitant inflammation and/or infection.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * with active inflammation or infection causing vascularization and possibly melting of the cornea, or vessels extending into the cornea causing lipid deposition, or vascularization that could significantly increase the risk of rejection of a current or planned corneal transplant, or vessels that continue to extend into the cornea despite topical treatment with corticosteroids. * signed written informed consent. exclusion criteria: * known sensitivity to treatment medications * current condition that in the investigator's opinion could compromise safety or data integrity. * pregnancy (including plan to become pregnant) or lactation during the course of the study
study to determine safety and dose of njh395 in non-breast her2+ advanced cancer

Conditions: NON-breast HER2+ Malignancies

Summary: a first-in-human study using njh395 in non-breast her2-positive advanced malignancies

this study has two parts. there will be a single dose of njh395 in the first part and multiple doses of njh395 in the second part. after the first part is completed, the second part may open.

Eligibility criteria:
key inclusion criteria: * patient must have known histologically or cytologically confirmed and documented her2-positive solid tumor excluding patients with breast cancer * advanced/metastatic cancer with measurable disease as determined by recist v.1.1 who have progressed or are intolerant to all approved therapies known to confer clinical benefit. * eastern cooperative oncology group (ecog) performance status ≤2. * patient must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. patient must be willing to undergo a new tumor biopsy prior to therapy, and during therapy on this study. key exclusion criteria: * history of severe hypersensitivity to any ingredient of study drug, trastuzumab or other monoclonal antibody. * patients previously treated with tlr 7/8 agonist. * impaired cardiac function or history of clinically significant cardiac disease * active, known or suspected autoimmune disease. * human immunodeficiency virus (hiv) infection * history of or current interstitial lung disease or pneumonitis grade 2 or greater. * discontinued prior checkpoint inhibitor due to a checkpoint inhibitor related toxicity. * currently receiving medications known to cause torsades de pointe that cannot be discontinued 7 days prior to starting treatment other protocol defined inclusion/exclusion criteria may apply.

Keywords: phase i, njh395, her2+, isac, tlr7
efectivity of non-invasive neuromodulation in parasympathic nervous system and vascular system

Conditions: Hypertension

Summary: the aim of the present study is to evaluate the acute effect immediately after the application of the nesa treatment in healthy participants in vascular sonographic variables measured in the left cca such as the ld, imt and psv, as well as systolic (sbp) and diastolic blood (dbp) pressure and heart rate (hr). the investigators hypothesized that nesa application will induce a direct influence in the vascular tone through the stimulation of the ans and the parasympathetic nerve system. this premise is based on the fact that non-invasive nesa neuromodulation enhance the autonomic regulation of vascular tone and endothelial function.

the aim of the present study is to evaluate the acute effect immediately after the application of the nesa treatment in healthy participants in vascular sonographic variables measured in the left cca such as the ld, imt and psv, as well as systolic (sbp) and diastolic blood (dbp) pressure and heart rate (hr). we hypothesize that nesa application will induce a direct influence in the vascular tone through the stimulation of the ans and the parasympathetic nerve system. this premise is based on the fact that non-invasive nesa neuromodulation enhance the autonomic regulation of vascular tone and endothelial function.a total sample of forty participants (n = 40; mean age 26.6 ± 6.7 years) were recruited for participation in the study. prior to entering the study, all participants received information about the study and signed a consent form to participate. the study subjects were divided into two equally distributed groups (a: nesa = 20; b: placebo = 20) and were blinded to the study group allocation. participants in the placebo group underwent the same procedural phases as those in the intervention group. however, for the placebo group, the device was set to deliver a low-intensity current below the sensory threshold, effectively rendering it inactive from the participants' perspective.

Eligibility criteria:
inclusion: - age between: 18-55 years, both sexes. exclusion: * cardiovascular disease. * specific pharmacology. * hypertension. * diabetes. * systemic diseases.
evaluation of adg20 for the treatment of mild or moderate covid-19

Conditions: COVID-19

Summary: this placebo controlled study is intended to generate safety and efficacy data in order to provide a treatment option for covid-19 in patients with a high risk of disease progression based on age or co-morbid medical conditions.


Eligibility criteria:
inclusion criteria: * has had sars-cov-2 positive antigen, rt-pcr, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization * has had symptoms consistent with covid-19 with onset 5 days before randomization * has one or more covid-19-related signs or symptoms on the day of randomization * phase 2: is an adult aged 18 years and above * phase 3: is an adult aged 18 years and above or is an adolescent aged 12 to 17 years (inclusive) and weighing ≥40 kg at the time of screening exclusion criteria: * is currently hospitalized or in the opinion of the investigator is anticipated to require hospitalization within 48 hours of randomization. * has severe covid-19 or is on supplemental oxygen * has a history of a positive sars-cov-2 antibody serology test * has participated, within the last 30 days, in a clinical study involving an investigational intervention * has received a sars-cov-2 vaccine, monoclonal antibody, or plasma from a person who recovered from covid-19 any time prior to participation in the study note: other protocol defined inclusion/exclusion criteria apply
pediatric risk of hypothyroidism with iodinated contrast media

Conditions: Hypothyroidism

Summary: this is a phase 4 multicenter prospective study to estimate the proportion of patients aged birth to 3 years who develop hypothyroidism within 6 months after receiving intravascular iohexol (omnipaque™), iodixanol (visipaque™), iopromide (ultravist®), or ioversol (optiray®) as the iodinated contrast medium (icm) for clinical evaluation during an icm-enhanced diagnostic imaging procedure.


Eligibility criteria:
inclusion criteria: * male and female patients aged birth to 3 years who, as part of the standard of care in the clinical practice of medicine, are referred to and will undergo a radiographic diagnostic imaging procedure that uses intravascularly administered iohexol (omnipaque™), iodixanol (visipaque™), iopromide (ultravist®), or ioversol (optiray®) as the icm for contrast enhancement. * written informed consent has been given for the patient by one or more parents or other legally acceptable representatives, as required by local regulations and laws. * when applicable (neonates), the patient's biological mother consents to providing information about her medical history and medication usage. * the patient has normal pre-procedure (screening) serum tfts (tsh, tt4, ft4, tt3), tsi, and urine (ui/ucr). * the patient's pre-procedure (screening) serum chemistry is either normal or not clinically significantly abnormal. * the patient has normal pre-procedure (screening) egfr for age by the revised schwartz formula \[schwartz et al 2009\]. * the patient's parent(s) or other legally acceptable representative(s) is/are able and willing to comply with the study schedule and procedures. exclusion criteria: * the planned radiographic procedure is part of a clinical research study rather than clinical practice. * the patient has known or suspected thyroid disease, down syndrome (trisomy 21), or type 1 diabetes. * the patient currently receives thyroid hormone replacement therapy, or such therapy is planned or being considered. * the patient has been exposed to thyroid protection for imaging procedures, within the last 6 months or such procedure is planned or being considered. * the patient currently receives one or more anti-thyroid medications, or such therapy is planned or being considered. * the patient has known or suspected past or present exposure to thyroid suppressants, including but not limited to drugs (e.g., amiodarone), inorganic iodide (potassium iodide, sodium iodide, etc.), perchlorate, thiocyanate, nitrate, lithium, and topical iodine disinfectant (e.g., povidone-iodine). * the patient has undergone (or is expected to undergo during the study) radiation treatments to the head or neck. * there is a high likelihood that the patient will undergo surgery or more than one icm-enhanced procedure in the following 10 weeks. * the patient has a history of hypersensitivity to icm or any components, or a history of a severe cutaneous adverse reaction to icm.

Keywords: hypothyroidism child iodine iodinated contrast medium (icm) thyroid function test (tft) iodixanol iohexol iopromide ioversol
fractional flow reserve versus angiography randomization for graft optimization trial

Conditions: Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Cardiovascular Diseases

Summary: the fargo trial is a prospective, randomized (1:1), multicenter study. the aim of the study is to assess the importance of fractional flow reserve (ffr) assessment prior to coronary artery bypass grafting (cabg) with respect to planning and guiding the revascularization strategy. the study compares an ffr-guided strategy to an angiography-guided strategy in patients planned for surgical revascularization.

ffr measurements are made on all patients that enters the study. ffr measurements on coronary arteries with intermediate stenoses, that are planned for grafting, are done before cabg is performed. patients are randomized to either an ffr-guided cabg or an angiography guided cabg.

Eligibility criteria:
inclusion criteria: * stable angina or unstable angina / nstemi (non st segment elevation myocardial infarction) candidate to cabg * at least one study lesion, which is an intermediate lesion planned for grafting at the heart team meeting.(definition of study lesions: ≥ 50% stenosis of a major epicardiel artery (where the proximal reference segment has a diameter\> 2.5 mm), which can be passed with a ffr-wire without significant risk. study lesions can be drawn from all coronary arteries.) * signed informed consent form exclusion criteria: * significant valvular disease with indication to surgical treatment * previous open-heart-surgery * left main lesion without other intermediate lesions * treatment with persantin retard * one vessel disease * renal impairment (creatinine ≥ 150 umol / l)
hs-crp as clinical marker of inflammatory atherogenic dyslipidemia

Conditions: Dyslipidemia

Summary: the objective of this proposal is to study the applicability of the hs-crp assay in the assessment of cv risk in daily clinical conditions where hyperlipidemic population with or without chd are currently evaluated.

coronary heart disease (chd) is the major cause of death in the developed world. cholesterol screening has been used as a tool to identify individuals who are at increased risk of developing future coronary events, but almost one-half of patients who develop myocardial infarction have either normal or only moderately increased serum cholesterol concentrations. in the last years, experimental and clinical evidence has demonstrated that atherosclerosis is not simply a disease of lipid deposits. rather, there is growing recognition that chd has an inflammatory component which plays a critical role in the arterial plaque rupture that triggers most episodes of coronary thrombosis. in the last years, c-reactive protein (crp), an exquisitely sensitive marker of systemic inflammation, has emerged as a powerful predictor of cardiovascular diseases, in particular of chd, beyond what can be estimated by traditional risk factors. the availability of high-sensitivity (hs) crp assays has enabled the detection of even low-grade inflammatory responses that have previously been regarded as clinically not meaningful. however, for hs-crp to make the transition from epidemiological and clinical research to the routine clinical setting, several important issues must be satisfactorily addressed. therefore, the overall objective of this proposal is to study the applicability of the hs-crp assay in the assessment of cv risk in daily clinical conditions where hyperlipidemic population with or without chd are currently evaluated and to evaluate hs-crp response to statins.

Eligibility criteria:
inclusion criteria: * metabolically stable in the last 3 months for weight (+/- 1 kg), lipid profile (+/- 15 % variability), infection (no symptoms for viral or bacterial illness), inflammation (absence of nonspecific symptoms for arthritis, normal blood sedimentation and protein electrophoresis for acute phase reactants) and no change of usual habits (ex. diet/exercise) or medications (ex. drugs) * chd patients will have to be stable (based on cardiac symptoms and ecg) during the last 3 months and diabetic patients will be required to have stable glycemia (hba1c \< 7,5 %) in the last 6 months. exclusion criteria: * history of drug or alcohol abuse * uncontrolled liver, thyroid or kidney functions * other drugs known to affect lipid levels or insulin resistance (antiprotease inhibitors, oral contraceptives...)