Kornimate/medical-research-clean huggingface dataset:
trial of autologous, hapten-modified vaccine in patients with stage iii or iv melanoma

Conditions: Melanoma

Summary: the purpose of this study is to determine whether a vaccine composed of patients' own melanoma cells treated with the chemical, dinitrophenyl (dnp)(called a hapten), is safe and stimulates an immune response to patients' own cancer cells.

patients with stage iii or iv melanoma need to have at least one tumor mass of at least 2.5 cm (about 1 inch) diameter than can be removed for vaccine production. if the vaccine is successfully made and if the patient is eligible, the patient will be assigned to receive one of 4 doses of the vaccine, include one group that will receive a zero dose. all patients will receive injections of their vaccine as part of immune system testing and will receive low dose cyclophosphamide and bcg. eight injections of the vaccine will be administered as an injection into the skin of the arm over a 6 month period. before and after vaccine administration, patients will be tested for immunity to their own melanoma cells by dth testing, which is similar to a tuberculosis test. all side effects caused by the vaccine will be recorded.

Eligibility criteria:
inclusion criteria: * stage iii or iv melanoma at least one tumor mass of at least 2.5 cm diameter that can be excised to make vaccine good performance status exclusion criteria: * brain metastases need for steroids or other immunosuppressive drugs positive ppd tests positive test for hiv, hepatitis b (antigen), or hepatitis c other serious medical illnesses

Keywords: melanoma metastatic vaccine immunotherapy autologous
accuracy of rib palpation for dry needling of deep periscapular musculature, measured with ultrasound

Conditions: Trigger Point Pain, Myofascial

Summary: ultrasound was used to identify the location of a rib. this was compared to a practitioner's ability to palpate the area.

ultrasound was used to identify the location of a rib. this was compared to a practitioner's ability to palpate the area. the purpose of this study is to identify if practitioners are as accurate as they think they are in identifying ribs. this is important, as mis-identifying a rib may put patients at risk for inadvertent needle entry into the lung.

Eligibility criteria:
inclusion criteria: * anyone with ribs exclusion criteria: * no children
comparison of low fat and low carbohydrate diets with respect to weight loss and metabolic effects

Conditions: Obesity

Summary: the investigators will test the hypothesis that a low carb hypocaloric diet will reduce body weight over six months more than a low fat hypocaloric diet. in addition to body weight, the investigators will measure cardiovascular and metabolic variables and will take blood samples in order to determine whether certain metabolites may predict the diet success.


Eligibility criteria:
inclusion criteria: * body mass index \> 27 kg/m2 * no chronic medication (except oral contraceptives and l-thyroxine) or possibility to stop medication for study duration * able to give written informed consent exclusion criteria: * pregnancy and nursing * severe cardiovascular, liver, kidney, hepatic or orthopedic disease that need treatment * metabolic or endocrine disease that need treatment * hypertension blood pressure \> 160/95 mmhg or need of \> 2 drugs * previous stroke or cerebral ischemia * significant neurologic or psychiatric disease * any kind of eating disorder * bariatric surgery in the past * drug or alcohol abuse * any cancer in the past * acute and chronic infections * metallic implants (e.g. pace makers) or conditions that do not allow mri scans * body weight \> 130 kg
risk identification of long-term complications

Conditions: Severe COVID-19

Summary: the investigators retrospectively analyze the clinical characteristics of severe covid-19 in our hospital, and then establish a prediction model for long-term complications in patients with severe covid-19, and strengthen follow-up to improve the prognosis of patients.

at present, there is a lack of prediction models for the long-term complications of severe covid-19. therefore, the investigators used the hospital big data platform to retrospectively analyze the clinical characteristics of severe covid-19 in our hospital, and conducted cohort follow-up of the changes in lung function including fev1, fvc，fev1% and dlco, etc and and high-resolution ct of patients after discharge. cox model and other statistical methods were used to establish a prediction model for long-term complications of severe covid-19, and early identification and intervention, strengthen follow-up, and improve the prognosis of patients.

Eligibility criteria:
inclusion criteria: the patient met the diagnostic criteria for severe covid-19 exclusion criteria: * pregnant women patients who died of covid-19 patients younger than 18 years of age without pulmonary ct

Keywords: covid-19 pneumonia long-term complications lung function
endothelial dysfunction evaluation for coronary heart disease risk estimation in rheumatoid arthritis (edra study)

Conditions: Rheumatoid Arthritis; Coronary Heart Disease

Summary: to evaluate the contribution of the assessment of endothelial dysfunction (ed) in improving coronary hearth disease (chd) risk stratification obtained by the framingham risk score (frs) in rheumatoid arthritis population (ra).

ed, determined by peripheral arterial tonometry (pat), will be evaluated at baseline in 3000 ra patients free of previous cardiovascular events. incident chd events during the 3-year planned follow-up will be registered. a measure of the incremental yield of ed will be obtained comparing 2-year framingham risk score for chd (frs) and frs plus ed differential prognostic performances by c-statics and risk reclassification analysis.

Eligibility criteria:
inclusion criteria: * ra as defined by american college of rheumatology/european league against rheumatisms 2010 ra classification criteria * in the opinion of investigators, patients must be able to adhere to the study visit schedule and must be capable of giving informed consent exclusion criteria: * previous cardiovascular or cerebrovascular events (acute coronary syndrome, stable angina, stroke, interventional procedures, carotid endarterectomy, symptomatic peripheral artery ischemia) * pathological ecg at rest * sign or symptoms of autonomous nervous system dysfunction * serious infections in the previous 6 months * concomitant severe illness: overt hepatic insufficiency; end stage renal disease (glomerular filtration rate \<30 ml/h at cockrofts-gault formula); recent diagnosis of cancer * pregnancy * plans to leave target areas of each study site within three years

Keywords: cardiovascular risk score framingham risk score 2-year endothelial dysfunction endopat rheumatoid arthritis
effects of radial shock waves therapy in the treatment of neck pain

Conditions: Neck Pain; Musculoskeletal Manipulations; Extracorporeal Shockwave Therapy

Summary: the aim of this study is to assess the effects of radial shock wave therapy in neck pain. for this objective, subjects recruited will be allocated in an experimental group or a placebo group. both groups will receive one manual therapy and radial shock waves therapy (real for experimental group, a sham device for placebo group) session per week along one month. neck pain, neck function, temporomandibular pain, temporomandibular function and quality of life measured will be performed before the intervention, after the last treatment and at one month follow-up.

neck pain is defined as discomfort or more intense forms of pain that are localized to the cervical region. the multifactorial etiology of neck pain includes trauma, ergonomic factors such as inappropriate postures, repetitive movements, strong physical activity, individual factors such as age, bmi, genetic factors, behavioral factors, and psychosocial factors. the prevalence of cervicalgia ranges from 16.7 to 75.1%, of which 50% will resolve within a short time and the other half will suffer pain for a longer time. there is a higher prevalence in widows and separated, people with few economic resources, jobs that involve physical effort, low educational level, anxiety and depression. furthermore, there is a high relationship between cervical pain and temporomandibular disorders. from this study, the investigators are going to carry out a non-invasive, analgesic, antiinflammatory treatment and without negative side effects for the patient through radial extracorporeal shock waves (reswt), and manual therapy (tm). among the effects produced by shock waves the investigators find that they improve circulation due to increased blood flow and oxygenation, at tissue level the permeability of the membrane increases and its metabolic process, therefore facilitating the activation of tissue regeneration processes experiencing dystrophic changes. furthermore, shock waves cause anti-inflammatory effects and muscle relaxation. the main objective of the study is to evaluate the capacity of the shock waves to improve the alterations due to neck pain. to meet the above objective, a single-blind randomized clinical trial study has been designed. the selected subjects will be of legal age diagnosed with neck pain and those subjects that due to their own characteristics are not able to carry out the study will be excluded. subjects will receive a weekly physical therapy session for four weeks. subjects will be randomly assigned to two groups: t1 intervention group consisting of subjects who will receive manual therapy treatment and shock waves and t2 placebo group in which the subjects will receive manual therapy and placebo shock waves.

Eligibility criteria:
inclusion criteria: * subjects diagnosed of neck pain. exclusion criteria: * subjects who due to their own characteristics are not able to carry out the study tests

Keywords: neck pain musculoskeletal manipulations extracorporeal shockwave therapy
validating digital biomarkers to detect disease activity and disease progression in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the connect-ms is multicentre real-world observational cohort study wherin the outcomes of standard care digital monitoring of 700 patients with multiple sclerosis (including all subtypes) are recorded over a follow-up period of two years. patients use the ms sherpa and neurokeys applications. outcomes are related to the utilisation of digital biomarkers including the adherence to digital monitoring and the impact digital outcomes have on clinical decision making, the effect of digital monitoring on healthcare consumption, and the ability of these technological biomarkers to detect clinical outcomes on the short and long term. most recorded variables are part of the standard care, however participants of this study are also subject to additional questionnaires regarding the consumption of healthcare and the influence of digital monitoring on decision making during clinical consultation.


Eligibility criteria:
in order to be eligible to participate in this study, a subject must meet all of the following criteria: * have signed non-wmo informed consent * be able to comply with the study protocol, as judged by the investigator. * have a minimum age of 18 years. * have a definite diagnosis multiple sclerosis (either rrms, spms or ppms) according to the revised 2017 mcdonald criteria. (thompson et al., 2018) * willing and able to install and use ms sherpa and neurokeys on a privately-owned cell phone. since this is an observational cohort study, concomitant participation in any intervention trial is allowed.

Keywords: digital monitoring mhealth multiple sclerosis
dynamic vision testing and concussion management

Conditions: Head Injury; Sport Injury; Concussion, Brain

Summary: the purpose of this study is to determine the value of including dynamic vision testing into california state university, northridge (csun) athletics' established concussion protocol. the study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.

the subjects of interest are csun student-athletes who give consent to participate in the study. dynamic vision will be assessed through the administration of the dynamic visual acuity (dva) test and the gaze stabilization test (gst). additionally, the 6-condition balance error scoring system (bess), which is currently a component of csun's established concussion protocol, will be administered to assess balance impairments. this cluster of tests will be administered three times per athlete: (1) during preseason to establish baseline measures, (2) acutely post-concussion once the athlete subject has been cleared by the team physician for return to exercise, and (3) when cleared to return to sport. the results will be used to evaluate whether or not dynamic vision results have returned to baseline by the time that csun athletics clears the athlete to "return to play."

Eligibility criteria:
inclusion criteria: * california state university northridge athletes * participants are able to give consent to participate in the study * completion of preseason testing for the 6-condition, bess, dva, gst with the research team * sustained a concussion as diagnosed by the medical staff during the 2020-2021 season of play. * sampling of convenience on a volunteer basis exclusion criteria: * athletes with preseason baseline tests on bess or dva that are not within the normative value range for an unimpaired individual. * the initial 6- condition bess score is \>20 errors * the subject is unable to attain a minimum of 85 degrees per second of horizontal head rotation when performing the dva test.
a vsa003 phase 1 study in chinese adult healthy volunteers

Conditions: Dyslipidemias; Familial Hypercholesterolemia; Hypertriglyceridemia

Summary: this is a randomized, double blinded, phase 1 study. the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of vsa003 in healthy adult volunteerst


Eligibility criteria:
inclusion criteria: * women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception * bmi 18.0\~28.0 kg/m2 * willing to provide written informed consent and to comply with study requirements * on a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study * tg\> 100 mg/dl * ldl-c\> 70 mg/dl exclusion criteria: * clinically significant health concerns * regular use of alcohol within one month prior to screening * recent (within 3 months) use of illicit drugs * female with pregnancy or breastfeeding * qtcf\>450 ms in ecg * donation or loss of whole blood more than 400 ml prior to administration of the study treatment note: additional inclusion/exclusion criteria may apply, per protocol
rapid non-invasive detection of aortic stenosis

Conditions: Heart Valve Diseases; Aortic Valve Disease; Heart Murmurs

Summary: avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. this study is designed to compare data obtained using avicena's device, the vivio, to data obtained from transthoracic echocardiography (tte) for the diagnosis of moderate-to-severe aortic stenosis. aortic stenosis (as) is a disease of the valve (aortic valve) that separates the left ventricle of the heart from the aorta. when as is severe, the heart cannot pump adequate amounts of blood into the arterial tree. as is often silent until the disease is severe. this study compares a rapid test using vivio to a longer and more expensive test that is the current gold standard for diagnosis of as, tte.

the study proposed here is a research study to develop the vivio system for diagnosis of severe as. the data gathered in this study will be used to optimize the avicena software algorithm used to make the diagnosis of as. the vivio device is an optical-type tonometer that operates based on capturing the vibrations of the skin due to the arterial pulse pressure wave as it propagates through the underlying carotid vessel. when applied to the neck over the subject's carotid pulse, an arterial waveform (pressure tracing) and heart sounds are sensed, and sent to an ipad using bluetooth, then sent to avicena for analysis. after informed consent subjects will undergo a brief cardiac-focused history and examination. all subjects will have bilateral exams with the vivio (\~5 minutes each) conducted by a study doctor or nurse, and a standard clinical resting tte conducted by a certified technician. the entire study visit should take 1.5 hours, and there is no follow up.

Eligibility criteria:
inclusion criteria: 1. adult subjects \>60 years of age 2. ability to understand and sign informed consent 3. willingness to undergo study protocol (in pasadena ca) exclusion criteria: 1. inability to provide informed consent 2. history of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck) 3. history of significant or symptomatic carotid artery disease, or carotid artery stenting or surgery 4. history of aortic valve surgery or transcatheter aortic valve replacement 5. absent carotid pulse on initial examination (inability to palpate the carotid pulse) 6. open skin lesions at the site of vivio application/examination 7. presence of a carotid bruit on examination

Keywords: echocardiography
dose-escalation study of d-cmg regimen for the treatment of elderly newly diagnosed aml patients

Conditions: Acute Myeloid Leukemia

Summary: to observe the dose-limiting toxicity (dlt) of liposomal mitoxantrone hydrochloride injection combined with cytarabine and decitabine in the initial treatment of acute myeloid leukemia (aml), to explore the maximum tolerated dose (mtd) of the combined d-cmg regimen, and to evaluate its safety and efficacy


Eligibility criteria:
inclusion criteria: 1. histologically confirmed acute myeloid leukemia (non-m3) that has not been previously treated and cannot receive standard cytarabine and anthracycline induction therapy due to age, comorbidities, or patient preference. 2. aged 60-75 years, both male and female, with an expected survival time of more than 3 months. 3. estimated creatinine clearance rate ≥ 30 ml/min. 4. ast and alt ≤ 3.0 x uln (unless considered due to leukemic organ involvement). bilirubin ≤ 1.5 x uln (unless considered due to leukemic organ involvement). 5. ecog performance status ≤ 2. 6. able to understand and voluntarily provide informed consent. exclusion criteria: 1. acute promyelocytic leukemia (apl) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16). 2. active central nervous system leukemia. 3. history of myeloproliferative neoplasms (mpn), including myelofibrosis, primary thrombocythemia, polycythemia vera, chronic myeloid leukemia (cml) with or without bcr-abl1 translocation, and aml with bcr-abl1 translocation. 4. hiv-positive patients and/or active hbv or hcv infection (as documented by positive hbv-dna and hcv-rna tests). 5. clinically significant qtc prolongation (men \> 450 ms; women \> 470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block, history of myocardial infarction within the past year, congestive heart failure, and coronary artery disease requiring medication. 6. active, uncontrolled severe infection. 7. history of other malignancies within the past 2 years, except for adequately treated in situ carcinoma of the cervix or breast; skin basal cell carcinoma or localized squamous cell carcinoma of the skin. 8. white blood cell count \> 25 x 10\^9/l. (this criterion can be met with hydroxyurea or leukapheresis.) 9. mental impairment that would compromise the ability to participate in the study. 10. any other situation in which the investigator believes that it would not be in the best interest of the patient to participate in the trial.
a simplified test to assess flavor in covid-19 patients

Conditions: Covid19

Summary: the flavor test has been developed and validated by our group to assess retro-nasal olfactory performances. the original flavor test has been simplified, with the great advantage to be self-administrable for covid-19 patients in isolation, without any risk to health professionals.

smell and taste dysfunctions (stds) are symptoms associated with covid-19 syndrome, even if their incidence is still uncertain and variable. in this study, the effects of sars-cov-2 infection on chemosensory function have been investigated using both a self-reporting questionnaire on smell and flavor perception, and a simplified flavor test. a total of 111 subjects (19 hospitalized \[hos\] and 37 home-isolated \[hi\] covid-19 patients, and 55 healthy controls \[ctrl\]) were enrolled in the study. the flavor test used consists in the self-administration of four solution with a pure olfactory stimulus (coffee), a mixed olfactory-trigeminal stimulus (peppermint), and a complex chemical mixture (banana). after sars-cov-2 infection, hos and hi patients reported similar frequency of stds, with a significant reduction of both smell and flavor self-estimated perception. the aromas of the flavor test were recognized by hi and hos covid-19 patients similarly to ctrl, however the intensity of the perceived aromas was significantly lower in patients compared to controls. this suggests that a chemosensory impairment is present after sars-cov-2 infection, and the modified "flavor test" could be a novel self-administering objective screening test to assess stds in covid-19 patients.

Eligibility criteria:
inclusion criteria: * adults (≥18 years of age) that gave their written informed consent to the study * diagnosis of covid-19 was confirmed by pcr of nasopharyngeal swab (hi or hos) * negative covid-19 nasopharyngeal swab (ctrl) * subjects with no critical conditions and able to understand the protocol exclusion criteria: * nasal obstruction or previous nasal diseases

Keywords: flavor smell flavor test hyposmia retro-nasal olfaction