Kornimate/medical-research-clean huggingface dataset:
elucid labs aida™ - labelled image acquisition protocol

Conditions: Melanoma (Skin); Basal Cell Carcinoma of the Skin; Squamous Cell Carcinoma of the Skin

Summary: diagnosis of melanoma involves physical examination of the lesion with many dermatologists adjunctively employing dermoscopes. the rate of misdiagnosis of melanoma remains significant, along with a high rate of referral to biopsy. elucid labs (waterloo, ontario) has developed a novel handheld, digital dermoscope with accompanying visualization and analysis software - the artificial intelligence dermatology assistant (aida™). apart from collecting conventional demoscopic images, aida also collects images at various spectral bands. the aim of this study is to understand and quantify the value of this novel adjunctive information for dermatologists diagnosing atypical skin lesions.

patients presenting with atypical skin lesions will undergo assessment by an investigator as per their standard clinical practice (not utilizing aida™). if a lesion meeting the inclusion-exclusion criteria is referred for biopsy, informed consent will be obtained and the subject will be enrolled. subjects will then have images acquired by the aida™ system. all lesions scheduled for biopsy (subgroup a) will be imaged along with at most 2 additional lesions meeting inclusion/exclusion criteria but not referred for biopsy (subgroup b). for each lesion imaged using aida™, the investigator will manually segment the lesion image and list any lesion features which contributed to their recommendation to biopsy or not biopsy. the investigator will first score the lesion according to the abcd rule using the standard dermoscopy image displayed. they will then state their diagnosis (malignant, dyplastic, or benign) and their diagnostic confidence using a visual analog scale. once standard demoscopy diagnosis has been collected, the process will be repeated with the use of aida™ software outputs. investigators will also provide an estimate of lesion depth based on aida™ depth images. all biopsy results will be recorded by the pathologist. histopathology determination will be used as the definitive diagnosis of either positive (malignant/dysplastic) or negative (benign). complete de-identified pathology reports may also be collected.

Eligibility criteria:
inclusion criteria: 1. is 18 years of age or older 2. has provided informed consent to participate in the study 3. is being evaluated by a dermatologist for at least one pigmented skin lesionscheduled for biopsy and meeting the following: 1. has a diameter of at least 1 mm and at most 10 mm 2. is accessible to the study device (allows for complete seal of device with skin-ie. no ambient light leakage) 3. is not within 1 cm of the eyes, on mucosal surfaces, palmar hands, plantarfeet, or under nails 4. is intact (eg. no open sores, ulcers, bleeding) 5. has not previously been biopsied, excised or traumatized 6. does not contain visible scarring or foreign material (eg. tattoos, etc.) exclusion criteria: 1. any allergy to isopropyl alcohol
diagnostic accuracy of salivary dna integrity index in oral malignant and premalignant lesions

Conditions: Oral Cancer; Oral Lichen Planus; Oral Leukoplakia

Summary: this study aims to identify the accuracy of dna integrity index in differentiating between oral premalignant lesions and oral cancer.

as stated by the u.s. preventive services task force and the national institute of dental and craniofacial research, the main screening test for oral cancer remains conventional oral examination of the oral cavity. most cases of oral cancer are preceded by a clinically visible lesion. these lesions are called oral potentially malignant disorders. these are leukoplakia, erythroplakia, oral submucous fibrosis, oral lichen planus and discoid lupus erythematosis. leukoplakia has a reported annual transformation rate of 2-3%, while olp has a rate of 0.5% . full thickness tissue biopsy is the "gold standard" for diagnosing suspicious lesions should they be encountered during coe. however, oral biopsy is an invasive technique that can be challenging in sites as the floor of the mouth or the soft palate . the invasive nature of a biopsy also makes it unsuitable for cancer screening in high-risk populations. thus there is a need for a diagnostic aid that can help primary care providers determine which patients need to be biopsied or referred to a specialist. nucleic acids can be released actively or passively into the circulation by both living and dead cells, where the latter is considered the predominant source. programmed cell death gives neatly digested dna fragments of approximately 180 bp in length. in case of solid tumors, cell-free dna is released through necrosis which generates longer dna fragments due to haphazard and incomplete digestion of dna. thus, the integrity of the dna fragment can determine its origin making dna integrity a potential marker for oral cancer. the dna integrity index (dii) is the ratio between the longer dna fragments to the shorter ones. a higher index has been reported in breast, prostate, liver and cervical cancer. jiang et al. 2006 found that the dna integrity index was significantly higher in oral cancer patients than in normal ones and reported a sensitivity and specificity values of 84.5% 83% respectively . the next step for such a marker would be early quantification of performance in clinical settings to determine if it is possible to extrapolate cut off values.

Eligibility criteria:
patients in this study will be divided into three groups: group i: patients diagnosed histopathologically with oral cancer recruited from the national cancer institute, who have yet to receive treatment. group ii: healthy controls inclusion criteria: * no visible oral lesions as detected by conventional oral examination * good oral hygiene, with healthy gingival tissues * non-smokers * no systemic disease group iii: patients diagnosed with oral lichen planus according to the modified who (van der meij and van der waal, 2003)diagnostic criteria not receiving treatment at least 8 weeks prior to enrollment.
photographing the skin during photodynamic therapy

Conditions: Basal Cell Carcinoma; Bowen's Disease

Summary: photodynamic therapy (pdt) is used to treat some types of sun-damaged skin and low-grade forms of growths. a cream is applied to the skin, and the chemical in this cream is absorbed in to the skin and converted in to a 'photosensitiser'. this photosensitiser is fluorescent, meaning that it produces red light when blue light is shone on it. by measuring how much light is given off with a camera, the investigators can determine how much photosensitiser is present in the skin. also, it is thought that more of the chemical is converted to the active photosensitiser if the skin is warmer, so the investigators plan to measure the temperature of the skin using a thermal camera. light is shone on to the skin and this activates the photosensitiser, treating the problem area and leaving healthy skin intact. this research will increase the investigators understanding of how pdt works, and may help the investigators to improve treatment regimens so that they can be made more effective and better tolerated


Eligibility criteria:
inclusion criteria: * 1. patients presenting with superficial bcc or bowen's disease (one or two lesions and diagnosed either clinically or histologically and untreated or having had no treatment for 4 months or longer) 2. adult males and females, \>18 years only 3. capable of giving informed consent 4. able to understand and adhere to protocol requirements exclusion criteria: * 1. patients skin lesions have had previous treatment in the last 4 months 2. unable to give informed consent 3. known allergy to metvix® 4. known to have a light sensitive disorder 5. pregnant, breastfeeding or planning to conceive
a 10-week study evaluating the efficacy and safety of pd 0332334 for the treatment of generalized anxiety disorder (3)

Conditions: Generalized Anxiety Disorder

Summary: this is a 10-week trial that evaluates the efficacy and safety of pd 0332334 in subjects ages 18 and older with generalized anxiety disorder.

termination reason: on february 23rd 2009, a decision to terminate further development for pd 0332334 was communicated to investigators in this study. the decision to terminate this study was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * diagnosis of gad (diagnostic and statistical manual-iv \[dsm-iv\], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the mini international neuropsychiatric interview (mini) for dsm-iv axis i disorders and other clinical information. subjects with specific phobia(s) (as defined in dsm-iv) or dysthymic disorder will be allowed in the study. * subjects must have a ham-a total score \>/= 20 at the screening (v1) and randomization (v2) visits. subjects must also have a covi anxiety scale score of \>/= 9 and a raskin depression scale score \</= 7 at the screening (v1) visit to ensure predominance of anxiety symptoms over depression symptoms. exclusion criteria: * subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies). * any of the following current (within the past 6 months through the present) dsm-iv axis i diagnoses: major depressive disorder; obsessive compulsive disorder; panic disorder; agoraphobia; posttraumatic stress disorder; anorexia; bulimia; caffeine-induced anxiety disorder; alcohol or substance abuse or dependence unless in full remission for at least 6 months; social anxiety disorder. * any of the following past or current dsm-iv axis i diagnoses: schizophrenia; psychotic disorder; delirium, dementia, amnestic and other clinically significant cognitive disorders; bipolar or schizoaffective disorder; cyclothymic disorder; dissociative disorders. * antisocial or borderline personality disorder. * serious suicidal risk per the clinical investigator's judgment.
imaging of pathologic fibrosis using 68ga-fap-2286

Conditions: Liver Fibrosis; Pulmonary Fibrosis; Myocardial Fibrosis

Summary: this is a single arm prospective pilot trial that evaluates the ability of a novel imaging agent (68ga-fap-2286) to identify pathologic fibrosis in the setting of hepatic, cardiac and pulmonary fibrosis. fap-2286 is a peptide that potently and selectively binds to fibroblast activation protein (fap). fap is a transmembrane protein expressed on fibroblasts and has been shown to have higher expression in idiopathic pulmonary fibrosis (ipf), cirrhosis, and cardiac fibrosis.

primary objectives: i. all cohorts: safety of 68ga-fap-2286. ii. cohort 1: measured uptake of radiotracer (suvpeak) in regions of known liver fibrosis. iii. cohort 2: measured uptake of radiotracer (suvpeak) in regions of known pulmonary fibrosis. iv. cohort 3: measured uptake of radiotracer (suvpeak) in regions of myocardial fibrosis. exploratory objectives: i. correlation of 68ga-fap-2286 uptake with fap expression determined by immunohistochemistry. ii. compare 68ga-fap-2286 scan results to archival computerized tomography (ct), magnetic resonance imaging (mri), or positron emission tomography (pet) images. patients will receive a single administration of 68ga-fap-2286 prior to pet imaging and will be followed for up to two hours after the injection of 68ga-fap-2286 for evaluation of adverse events.

Eligibility criteria:
inclusion criteria: 1. age \>= 18 years. 2. confirmed pathologic fibrosis in one of the following cohorts 1. cohort 1: hepatic fibrosis, based on cirrhosis on imaging or hepatic fibrosis on liver biopsy. 2. cohort 2: pulmonary fibrosis, based on ct findings or biopsy of lung parenchyma. 3. cohort 3: high likelihood of cardiac fibrosis as indicated by known cardiac sarcoidosis or amyloidosis (shown on mri or fluorodeoxyglucose (fdg) pet), recent myocardial infarction within the last 30 days (as shown by an elevated troponin), known cardiotoxicity (decreased ejection fraction on systemic therapy), or other known inflammatory or infiltrative disease. 3. ability to understand a written informed consent document, and the willingness to sign it. exclusion criteria: 1. unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation. 2. known pregnancy.

Keywords: positron emission tomography (pet) imaging 68ga-fap-2286
cmr repeatability in stemi

Conditions: STEMI

Summary: the investigators propose to conduct a study to measure the reproducibility of cmr parameters that have been used to predict outcome following ppci: infarct size, left ventricular volumes, myocardial salvage, microvascular obstruction (mvo) and myocardial oedema.


Eligibility criteria:
inclusion criteria: participant may enter study if all of the following apply 1. st segment myocardial infarction as defined by ecg (by 2 contiguous limb leads with \>1 mm st-segment elevation, or \>2 mm st-segment elevation in contiguous precordial leads, or new lbbb) and \> 20 minutes of cardiac chest pain 2. written informed consent exclusion criteria: participant may not enter study if any of the following apply 1. contraindication to mri (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for cmr scanner) 2. known allergy to gadolinium 3. chronic atrial fibrillation 4. renal impairment with egfr \<30 5. cardiogenic shock 6. patients with special communication needs
observer reactivity during gait measurements in a clinical setting

Conditions: Stroke

Summary: observer reactivity, also known as the 'hawthorne effect', can roughly be described as the alteration of behaviour as a consequence of observation or awareness of measurement. although researchers are aware of a potential observation effect during measurements, observer reactivity may also influence assessments that are performed as part of clinical care. previous research on observer reactivity during gait measurements has resulted in contradicting outcomes and most studies examined the effects of participation in research rather than the clinical measurement of gait in a gait lab setting or the observation by professionals. therefore, the aim of this study is to examine the differences in gait pattern between unobserved walking, observed walking, and observed walking combined with awareness of measurement, in a within-subjects repeated measures design.

observer reactivity, also known as the 'hawthorne effect', can roughly be described as the alteration in behaviour as a consequence of observation or awareness of measurement. it is believed that this could influence research outcomes in prospective experimental and observational studies. however, as described in a recent systematic review, the extend of the effect on research outcomes is still debated. the available studies on observer reactivity with various populations and tasks generate contradicting findings and conclusions. especially within the health sciences, more research is necessary as observer reactivity may confound study results in the direction of better health outcomes. previous research on observer reactivity during gait measurements has resulted in contradicting outcomes. for example, some studies showed a higher walking velocity and better gait symmetry under observation, while others showed an opposite effect. this may be caused by the variation in diagnosis group between the studies or small sample sizes. because of these mixed results and the low number of studies available on this topic, there is yet no consensus on a generalizable effect of observation during gait measurements. furthermore, most studies examine the effects of participation in research rather than the clinical measurement of gait in a gait lab setting or the observation by professionals. for clinical decision making, it is essential to investigate whether gait measurements are representative for the actual gait pattern of the patient. therefore, the aim of this study is to examine the differences in gait pattern between unobserved walking, observed walking by a researcher, and observed walking combined with awareness of measurement by sensors.

Eligibility criteria:
inclusion criteria: * subacute or chronic stroke (\>3 months ago) exclusion criteria: * not able to walk 50 meters without resting. * not able to understand instructions given by the researcher.
a study of purified human antibodies administered subcutaneously to patients with multifocal motor neuropathy (mmn)

Conditions: Multifocal Motor Neuropathy (MMN)

Summary: the objective of this study is to assess efficacy, safety, and convenience of purified human antibodies administered under the skin in the treatment of mmn patients.


Eligibility criteria:
inclusion criteria: * patients with documented clinical diagnosis and electrophysiological evidence of mmn * patients who have previously responded to intravenous immunoglobulin (ivig) and have been on stable treatment with ivig for at least 12 weeks prior to screening * patients treated with the equivalent of ≥0.4g/kg body weight (bw) ivig per month * provision of informed consent by patient exclusion criteria: * aspartate aminotransferase (asat) or alanine aminotransferase (alat) concentration \>2.5 times the upper normal limit (unl) * creatinine concentration \>1.5 times the unl * known allergic reactions to blood products * any skin disease interfering with the assessment of injection site reactions * any other medical condition, which in the opinion of the investigator, might interfere with successful completion of the protocol * any condition likely to interfere with the evaluation of the study drug or satisfactory conduct of the trial * participation in a study with an investigational drug within three months prior to enrolment * patients treated with the equivalent of \>2.0g/kg bw ivig per month
a nutritional intervention in police officers

Conditions: Overweight; Blood Pressure; Diabetes Mellitus, Type 2

Summary: the proposed study seeks to test the effect of a plant-based dietary intervention on cardiovascular risk factors in police officers.

this study tests the hypotheses that a low-fat, plant-based (vegan) diet improves body weight, plasma lipid concentrations, blood pressure, and, in individuals with type 2 diabetes, glycemic control, that a low-fat, plant-based diet improves health-related quality of life as measured by the medical outcomes study short form 36-item health survey (sf-36), and that a low-fat, plant-based diet improves mood, as measured by the center for epidemiologic studies depression scale-revised (cesd-r).

Eligibility criteria:
inclusion criteria: 1. men and women at least 18 years 2. body mass index ≥ 25 kg/m2 and/or a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥ 126 mg/dl on two occasions or a prior physician's diagnosis of type 2 diabetes 3. currently an employee of the metropolitan police department of the district of columbia 4. ability and willingness to participate in all components of the study 5. a willingness to be randomly assigned to either study group exclusion criteria: 1. alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use 2. use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion) 3. pregnancy 4. unstable medical or psychiatric illness 5. likely to be disruptive in group sessions (as determined by research staff) 6. already following a low-fat, vegan diet 7. lack of english fluency 8. inability or unwillingness to participate in all components of the study

Keywords: diet, vegetarian diet, fat-restricted quality of life glycemic index
in-hospital comprehensive geriatric assessment in aged acute medical patients

Conditions: Acute Disease

Summary: the purpose of this study is to compare acute ill elderly medical patients in a geriatric department with general medical departments, and to examine the effects of comprehensive geriatric assessment in the geriatric setting compared with general medical care.

design: 1) a cross-sectional study followed by 2) a subgroup study by retrospective follow-up

Eligibility criteria:
inclusion criteria: * patients admitted to the departments of medicine at aarhus university hospital either through the emergency medical ward or directly to the medical wards in the period from january 1, 2009 to december 31, 2010. exclusion criteria: * patients admitted to the neurology-, cardiology-, nephrology- or haematology departments, and patients discharged directly to their homes from the emergency medical ward.

Keywords: acute medical care comprehensive geriatric assessment health services for the aged geriatric assessment geriatrics aged
protease inhibitor monotherapy versus ongoing triple-therapy in the long term management of hiv infection (pivot)

Conditions: HIV Infection; Acquired Immunodeficiency Syndrome

Summary: the pivot trial aims to determine whether a strategy of switching to pi monotherapy is non-inferior to continuing triple-therapy, in terms of the proportion of patients who maintain all the drug treatment options that were available to them at baseline after at least 3 years of follow-up, and to compare clinical events, safety, toxicity and health economic parameters between the two strategies.


Eligibility criteria:
inclusion criteria: vl \ 100 at screening exclusion criteria: 1. known major protease resistance mutation(s) documented on prior resistance testing if performed (prior resistance testing is not mandatory for trial participation). 2. previous change in art drug regimen for reasons of unsatisfactory virological response (patients who have changed regimen for prevention or management of toxicity or to improve regimen convenience are permitted to enter the trial). 3. previous allergic reaction to a pi. 4. patient currently using or likely to require use of concomitant medication with known interaction with pis. 5. patient requiring treatment with radiotherapy, cytotoxic chemotherapy, or is anticipated to need these during the trial period. 6. treatment for acute opportunistic infection within 3 months prior to trial screening. 7. pregnant or trying to become pregnant at the time of trial entry. 8. history of active substance abuse or psychiatric illness that, in the opinion of the investigator, would preclude compliance with the protocol, dosing schedule or assessments. 9. history of hiv encephalopathy with current deficit \>1 in any domain of the neuropsychiatric aids rating scale (see appendix 7). 10. past or current history of cardiovascular disease, or 10 year absolute coronary heart disease risk of \>30%, or risk of \>20% if the patient has diabetes or a family history of premature ischaemic heart disease or stroke. 11. history of insulin-dependent diabetes mellitus. 12. patient currently receiving interferon therapy for hepatitis c virus infection or planning to start treatment for hepatitis c at the time of trial entry. 13. co-infection with hepatitis b, defined as hepatitis bsag positive at screening or at any time since hiv diagnosis, unless the patient has had a documented hepatitis b dna measurement of less than 1000 copies/ml taken whilst off hepatitis b active drugs. 14. any other active clinically significant condition, or findings during screening medical history or examination, or abnormality on screening laboratory blood tests that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial. 15. fasting plasma glucose \>7.0mmol/l at trial screening.

Keywords: protease inhibitors rna virus infections virus diseases sexually transmitted diseases viral immune system diseases anti-infective agents drug resistance