Kornimate/medical-research-clean huggingface dataset:
back pain response to different acupuncture methods

Conditions: Lower Back Pain

Summary: acupuncture has been used for many years to help relieve pain. however, it is not clear how acupuncture works. we are doing this study to learn about the effects of different forms of acupuncture on chronic low back pain. we are interested in learning about brain activity during pain. we plan to look at brain activity at the beginning and the end of the study, after 6 sessions of acupuncture.


Eligibility criteria:
inclusion criteria: * volunteers 18-60 years of age. * meet the classification criteria of the chronic lbp (having low back pain for more than 6 months), as determined by the referring physician. * at least 4/10 clinical pain on the 11-point lbp intensity scale. * patients must be able to provoke or exacerbate their chronic lbp using our calibrated exercise-like maneuver. * must have had a prior evaluation of their low back pain by a health care provider, which may have included radiographic studies. documentation of this evaluation will be sought from partners or outside medical records and kept in the subject's research record. * at least a 10th grade english-reading level; english can be a second language provided that the patients feel they understand all the questions used in the assessment measures. exclusion criteria: * specific causes of back pain (e.g. cancer, fractures, spinal stenosis, infections), * complicated back problems (e.g. prior back surgery, medicolegal issues), * possible contraindications for acupuncture (e.g. coagulation disorders, cardiac pacemakers, pregnancy, seizure disorder), and conditions that might confound acupuncture intervention effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis). * conditions making acupuncture difficult (e.g. paralysis, psychoses), * prior acupuncture treatment for back pain; 1 year wait for any other type. * the intent to undergo surgery during the time of involvement in the study. * history of cardiac, respiratory, or nervous system disease that, in dr. wasan's judgment, precludes participation in the study because of a heightened potential for adverse outcome. for example: asthma or claustrophobia. * presence of any contraindications to mri scanning. for example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy. * involvement in workmen's compensation or disability claims. * radicular pain extending below the knee. * active substance abuse disorders within the last 24 months, based on subject self-report. * use of more than 60 mg morphine equivalent prescription opioids or steroids for pain.

Keywords: lower back pain acupuncture
pain perception of needle-free system

Conditions: Pain; Needle Phobia; Anxiety; Dental Fear; Local Anesthesia

Summary: the purpose of this study is to evaluate and compare the pain perception associated with a needle-free injection system( comfort-in) and dental injection method in filling and pulpotomy treatments

needle-free injection system(comfort-in) and dental injection method was applied on the teeth of children who need dental treatment.70 patients were included in the study. patients were randomized into two grups according to the injection technique. group1: needle-free injection system(comofrt-in) 2:dental injection method. the pain intensity was assessed during anesthesia, during treatment and at the end of thetreatment by the wong baker faces pain scale. the datas were analyzed with a three-way variance method in repeated.

Eligibility criteria:
inclusion criteria: * aged between 4-11 years * having no developmental or systemic disorder or no history of allergy * having "positive" or "definitely positive" cooperation level according to the frankl behavior scale * having sufficient mouth opening * operation only on primary teeth * having decayed teeth that require anesthesia exclusion criteria: * patients younger than five years, older than 11 years, * patients with systemic or developmental disorders * children with an allergy history * 'negative' or 'definitly negative' behavior rating according to the frankl scale * patients whose mouth opening is not sufficient for dental treatment * operating only on permanent teeth * teeth that are beyond the treatment stage * when pain occurred during treatment, supplemental anesthetics administrated, and these children were excluded.

Keywords: children dental injection needle-free injection system pain pulpotomy
prostate accurately targeted radiotherapy investigation of overall treatment time

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to compare the toxicity of two new radiation schedules for the treatment of prostate cancer. patients will be randomized to receive 5 treatments delivered every other day over 11 days, or once per week over 29 days. both of these schedules are shorter than the standard treatment which is usually 39 treatments over 8 weeks.


Eligibility criteria:
inclusion criteria: * low or intermediate risk prostate cancer patients as defined by: * clinical stage t1-2b, gleason score \<=7, and psa \<=20 ng/ml * age \>= 18 years exclusion criteria: * androgen deprivation therapy (lhrh-agonists or antiandrogens) \>6 months * prior pelvic radiotherapy * anticoagulation medication (if unsafe to discontinue for gold seed insertion) * diagnosis of bleeding diathesis * large prostate (\>90cm3) on imaging * immunosuppressive medications * inflammatory bowel disease

Keywords: radiotherapy hypofractionation
gl-onc1 administered intravenously prior to surgery to patients with solid organ cancers

Conditions: Solid Organ Cancers

Summary: the purpose of this study is to evaluate the safety of the investigational product gl-onc1. gl-onc1, a vaccinia virus, has been genetically modified for use as a potential anti-cancer drug to destroy cancer cells. vaccinia virus has been used successfully in the past as smallpox vaccine in millions of people worldwide.

this is an open-label, non-randomized phase 1b dose escalation study evaluating the safety and effect of the oncolytic virus gl-onc1 administered intravenously, with or without eculizumab, prior to surgery in patients with advanced solid organ tumors. gl-onc1 is a genetically engineered oncolytic vaccinia virus, which disrupts nonessential genes and expression of the foreign gene expression. evidence suggest that gl-onc1 is able to infect tumor tissue and kill tumor cells. the goals of this study are to evaluate the safety of gl-onc1 and to assess the pharmacokinetics and pharmacodynamics profile of gl-onc1 in vivo.

Eligibility criteria:
inclusion criteria: * histologically-proven diagnosis of advanced (ajcc, 7th edition: stage iii or iv) or aggressive solid organ cancer. * patients must provide written consent for a core needle biopsy sample of tumor tissue (primary or metastatic). * have evidence of measurable disease (according to recist version 1.1: http:// www.recist.com). * have an ecog performance score of 0 to 2. * have a life expectancy of at least 3 months. * have adequate organ and marrow function * negative serum pregnancy test for females of childbearing potential. * have negative test result for hiv and hepatitis b or c testing. * have baseline anti-vaccinia antibody titer \< 10. exclusion criteria: * current or anticipated use of other investigational agents or marketed anticancer agent while on study (from the time of enrollment through the time of surgery). * patients who have received chemotherapy or radiotherapy within 4 weeks prior to entering the study. * small pox vaccination for 4 weeks before study therapy and during study treatment. * have received prior gene therapy or therapy with cytolytic virus of any type. * have clinically significant cardiac disease * oxygen saturation \<90% measured by pulse oximetry at rest. * receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, st-246) during the course of study. * have known allergy to ovalbumin or other egg products. * have clinically significant dermatological disorders (e.g., eczema, psoriasis, or any unhealed skin wounds or ulcers) * have a history of allergy to iodinated contrast media. * patients with known brain metastases * pregnant or nursing

Keywords: gl-onc1 solid organ cancer cancer surgery oncolytic virus soliris metastatic melanoma esophageal and gastric adenocarcinoma (stage iii/iv) cholangiocarcinoma pancreatic adenocarcinoma gallbladder cancer colorectal cancer (stage iv) high-grade mucinous appendix cancer high-grade gastrointestinal neuroendocrine cancer mesothelioma high-grade soft tissue sarcoma stage iii or iv
efficacy and safety of darunavir and cobicistat for treatment of covid-19

Conditions: Pneumonia, Pneumocystis; Coronavirus

Summary: the study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of covid-19 pneumonia

there is no vaccine or antiviral treatment for human coronavirus, so this study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of covid-19 pneumonia.

Eligibility criteria:
inclusion criteria: * the participants were diagnosed as covid-19 pneumonia, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4 or update version) made by national health commission of the people's republic of china. * written the informed consent exclusion criteria: * hypersensitivity to darunavir, cobicistat, or any excipients * patients with severe liver injury (child-pugh class c) * concomitant medications that are highly dependent on cyp3a clearance, and the elevated plasma concentrations are associated with serious or life-threatening events. * subjects were considered to be unable to complete the study, or not suitable for the study by researchers exit criteria: * subjects asked to withdraw the study * subject will benefit if withdraw according to researchers' suggestions

Keywords: pneumonia covid-19 darunavir cobicistat
individualization flow in patients treated with high flow nasal therapy (iflow)

Conditions: High-Flow Nasal Cannula; Oxygen Therapy; Acute Respiratory Failure; Respiratory Failure; Lung Injury

Summary: in patients with acute hypoxemic respiratory failure (ahrf), high flow nasal therapy (hfnt) improves oxygenation, tolerance, and decreases work of breathing as compared to standard oxygen therapy by facemask. the hypothesis is that this flow challenge (rox index variation from 30 to 60l/min) could be used as a test for assessing changes in lung aeration, analyzed by the variation in end expiratory lung volume (δeelv), in patients treated with hfnc. it may allow to personalize the flow settings during hfnc. in this sense, an increase in eelv will be observed with higher flows in responders and, therefore, these participants may benefit from increasing the flow. in contrast, to increase the flow in non-responders (no significant increase in eelv with higher flows) increase the risk of patient self-inflicted lung injury (p-sili).


Eligibility criteria:
inclusion criteria: * adult patient admitted to the icu requiring nhf due to ahrf that will be defined as an spo2/fio2 ratio \<315 exclusion criteria: * patient with indication for immediate cpap, niv, or invasive mechanical ventilation * hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h * severe acidosis (ph ≤ 7.25) * pregnant woman * tracheotomised patient * formalized ethical decision to withhold or withdraw life support * patient under guardianship * patient deprived of liberties * patient already enrolled in the present study in a previous episode of acute respiratory failure * patient who does not consent.

Keywords: high-flow nasal cannula oxygen therapy electrical impedance tomography lung injury acute respiratory failure
understanding covid-19 infections in pregnant women and their babies in 5 african nations (pericovid africa)

Conditions: Covid19; Pregnancy Related

Summary: develop coronavirus disease 2019 (covid-19) surveillance in pregnancy in the gambia, kenya, malawi, mozambique and uganda estimate the seroepidemiology of covid-19 infection among pregnant women in these countries define the immune response to severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in pregnant women and their babies and determine the presence of antibodies in cord blood work with communities to develop understanding of infection prevention and control techniques to reduce the spread of covid-19 amongst the pregnant population

this study has been set up as part of the response to the international outbreak of the novel severe acute respiratory syndrome coronavirus 2 (sars cov-2). the aim of the study is to answer important questions about the impact of the novel coronavirus on pregnant women and their infants. the investigators aim to describe the sero-epidemiology and burden of covid-19 disease among pregnant women, as well as the impact on maternal and neonatal health, by collecting epidemiological data and by collecting samples during pregnancy, labour and delivery and in the neonatal period. data from this study will be pooled from 5 countries; malawi, uganda, mozambique, the gambia, and kenya to provide robust and generalisable evidence from the different regions in sub-saharan africa. the investigators hope that with this information, they can contribute to the evidence base for recommendations, guidance and policy decisions for the clinical management and public health response to protect pregnant women and their infants.

Eligibility criteria:
inclusion criteria: * any pregnant woman or emancipated minor at any gestation, up to and including day of delivery. individual study sites may have their own specific inclusion/exclusion criteria which is not listed here. * accepts to read or to be read to and sign or fingerprint the approved study consent form
near-infrared laser stimulation for various neurological conditions

Conditions: Refractory Depression; Anxiety Disorders; Neurodegenerative Diseases; Traumatic Brain Injury; Chronic Traumatic Encephalopathy

Summary: the study will evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, neurodegenerative disease, and traumatic brain injury.

the present study is being undertaken as an open-label study to evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, cognitive impairment due to a neurodegenerative disease (e.g., alzheimer's), and traumatic brain injury. baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures. the present study can be easily implemented because instruments have been in routine clinical deployment providing for a high degree of availability and reliability. quality assurance is tightly controlled. the study population is sufficiently broad and the conditions of interest are sufficiently prevalent so that recruitment of subjects is not a limiting factor.

Eligibility criteria:
inclusion criteria (depression): * diagnosis of major depressive disorder * score greater than 13 on the beck depression inventory * failure to remit with 3 antidepressants * at least 18 years of age inclusion criteria (anxiety): * diagnosis of generalized or acute anxiety disorder * score greater than 22 on the beck anxiety inventory * failure to remit with 3 anxiolytics * at least 18 years of age inclusion criteria (neurodegenerative dementia): * cognitive decline with mild cognitive impairment (clinical dementia rating stage 0.5) through moderate dementia (cdr stage 2) * lumbar puncture for abeta 42 and tau proteins evincing clinical correlation of neurodegenerative disease pathology * advanced mri of the brain including volume measurement of the hippocampus, blood-oxygen level dependent imaging, and arterial spin labeling perfusion scans. on entry, patients will have cdr stage of at least 0.5 and at least one abnormal imaging biomarker. inclusion criteria (tbi/cte): * diagnosis of traumatic brain injury or chronic traumatic encephalopathy * at least 18 years of age exclusion criteria: * macular degeneration * subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer) * advanced kidney, pulmonary, cardiac or liver failure * advanced terminal illness * any active cancer or chemotherapy * bone marrow disorder * myeloproliferative disorder * sickle cell disease * primary pulmonary hypertension * immunocompromising conditions and/or immunosuppressive therapies * any other neoplastic illness or illness characterized by neovascularity * subjects unable to give informed consent * subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep * recent surgery or dental work within 3 months of the scheduled procedure. * pregnancy, women who may become pregnant or are breastfeeding
lux-head&neck 1: a phase iii trial of afatinib (bibw2992) versus methotrexate for the treatment of recurrent and/or metastatic (r/m) head and neck squamous cell cancer after platinum based chemotherapy

Conditions: Head and Neck Neoplasms; Carcinoma, Squamous Cell

Summary: this randomised, open-label, phase iii study will be performed in patients with r/m head and neck squamous cell carcinoma (hnscc) who have progressed after platinum-based therapy. the objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed r/m hnscc of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy 2. documented progressive disease based on investigator assessment according to response evaluation criteria in solid tumours (recist) following receipt of at least two cycles of cisplatin or carboplatin administered for r/m disease 3. measurable disease according to recist 4. eastern cooperative oncology group (ecog) performance status 0 or 1 exclusion criteria: 1. progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic hnscc 2. any other than one previous platinum based systemic regimen given for r/m disease 3. prior treatment with epidermal growth factor receptor (egfr)-targeted small molecules 4. pregnancy or breast feeding
covid-19 and sars-cov-2 detection in saliva

Conditions: RNA Virus Infections

Summary: this study aims to validate the use of human saliva as a substrate for an assay to detect sars-cov-2 and define accuracy, analytical sensitivity and specificity of the taqpath rt-pcr test.

investigators will carry out validation of a laboratory assay to detect sars-cov-2 nucleic acids in human saliva samples. data for the validation will include the test results from standard nasopharyngeal (np) swabs (controls) and matched saliva samples (experimental group) of individuals who are either known to be infected or at high risk of being infected. investigators hypothesize that the performance of an assay designed specifically for saliva will not perform differently, as defined by a predetermined margin, from the standard assay performed on np and other respiratory samples

Eligibility criteria:
inclusion criteria: * reads and understands english or spanish * willing and able to provide consent * diagnosed with covid-19 or at high risk of disease based on objective criteria exclusion criteria: * unwilling or unable to provide consent. * pregnant female

Keywords: detection
development of a novel screening tool for anosognosia after stroke.

Conditions: Anosognosia; Stroke

Summary: anosognosia, a neurological inability to acknowledge or comprehend one's own (dis)abilities, is a multi-faceted phenomenon which has consistently gained traction in research fields spanning psychology, neurology, and cognition since its conceptual introduction in 1914. though anosognosia is not limited to following only neurological disease or injury, the majority of research has focused on the prevalence and mechanisms of anosognosia after stroke. despite this, there is no clear consensus among the literature, and thus in clinical practice, as to how anosognosia after stroke should be assessed. this is startling given the plethora of studies which highlight anosognosia as a barrier to rehabilitation, a risk to safe discharge, and a predictor of poorer psychological and functional outcomes for both patients and their carers. currently, there exists a vast number of assessment methods for anosognosia after stroke, which vary from performance- and observation-based tasks to self-report and discrepancy-based interviews; clinicians working in stroke make arbitrary choices as to which of these methods to use on a case-by-case basis, risking missed cases and subsequently noncomprehensive care. this research aims to develop a new screening tool for anosognosia that can be routinely implemented with post-stroke patients in hospital settings, to inform care, rehabilitation, and discharge. the study will explore the acceptability and feasibility of the new screening tool among multi-disciplinary staff working on a stroke rehabilitation unit, and provide grounds for future studies to assess the screen's psychometric properties and ability to inform novel interventions for anosognosia. findings will have great implications for stroke survivors, their carers, and healthcare professionals alike.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or above who are admitted to the stroke rehabilitation unit with a clinical diagnosis of stroke. * multi-disciplinary staff working on the stroke rehabilitation unit. exclusion criteria: * patients with a clinical diagnosis other than stroke.

Keywords: anosognosia stroke assessment
automated deep brain stimulation programming using functional mapping

Conditions: Parkinson Disease

Summary: participants will undergo dbs programming guided by the dbs-expert system and by a clinician per standard care.


Eligibility criteria:
inclusion criteria: * the ability to provide informed consent * clinical diagnosis of idiopathic parkinson's disease (pd) * implanted deep brain stimulation (dbs) system for tremor and/or bradykinesia exclusion criteria: * significant medical or psychiatric illness or dementia as evidenced by a score less than 26 on the montreal cognitive assessment * not capable of functioning independently * individuals so symptomatic as to compromise safety

Keywords: deep brain stimulation (dbs) kinesia
adhoc mindfulness-based research

Conditions: Hiv; Loneliness; Depression; Anxiety

Summary: the ambr study (adhoc mindfulness-based research study) is a randomized controlled trial that examines the effectiveness of teaching mindfulness-based techniques through online lessons to combat loneliness, anxiety, and depression among people living with hiv over the age of 50. it is a substudy of the adhoc study (clinicaltrials.gov identifier nct04311554).

the ambr study is a randomized controlled trial that examines the effectiveness of teaching mindfulness-based techniques through online lessons to combat loneliness, anxiety, and depression among people living with hiv who are over the age of 50 and enrolled in adhoc (clinicaltrials.gov identifier nct04311554). the intervention consists of 14 mindfulness audio lessons, each approximately 20-minutes long. the mindfulness lessons are designed to develop three core skills: concentration (the ability to maintain focus on present-moment experiences), clarity (the ability to pinpoint exactly what you are experiencing in each moment), and equanimity (openness to experience).

Eligibility criteria:
inclusion criteria: * adhoc participant with a score of 4 or higher on the 3-item loneliness questionnaire from their adhoc profile * clinical diagnosis of hiv * able to read and write in english * able and willing to provide online informed consent and complete study activities online * access to a smartphone or computer exclusion criteria: - acute medical problem(s) requiring immediate inpatient treatment