Kornimate/medical-research-clean huggingface dataset:
evaluation of infrared cameras and non-contact infrared thermometers for measuring body temperatures

Conditions: Fever

Summary: fever is one of the key symptoms exhibited by contagious patients infected with the ebola and other viruses. thermographs and non-contact infrared thermometers (ncits) are commonly used as early detection tools for screening and isolating sick individuals in healthcare settings and transit centers such as airports. the objective of this clinical study is to evaluate the temperature measurement accuracy of thermographs and ncits. the study will be accomplished by establishing a protocol based on best practices for screening published in the iec 80601-2-59:2008 medical electrical equipment -- part 2-59: particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening standard, performing initial measurements in patients to optimize clinical procedures, then performing quantitative clinical measurements in febrile and afebrile human subjects to compare thermographs - used in accordance with recognized best practices for measurement - with ncits for fever screening. since thermographs and ncits represent the only currently viable mass screening approaches for infectious disease pandemics, like the recent ebola virus disease (evd) outbreak in west africa, the study will evaluate these thermal modalities as medical countermeasures for fever-related pandemics and therefore improve response to these diseases.


Eligibility criteria:
inclusion criteria: * any human subject above the age of 18 that can sit for about 40 minutes with permitted breaks as needed and follow the study instructions can be included. exclusion criteria: * human subjects should be free of recent (1 week prior) or current disease affecting the icr and forehead skin. they should not use topical cosmetics, creams or medications on the face on the day of participation.
jasper intervention in down syndrome

Conditions: Down Syndrome, Trisomy 21

Summary: the goal of this study is to determine whether jasper (joint attention, symbolic play, engagement, regulation), which is an intensive, targeted early behavioral intervention focused on a developmentally based approach for teaching joint engagement, joint attention, and play skills can improve behavioral / emotional regulation, social communication skills, and developmental trajectories in down syndrome (ds). the investigators will also explore the potential use of eeg and event-related potentials (erp) as outcome measures, as this approach may help elucidate mechanisms of change in behavior and development, and may help explain differences in development of social communication skills in individuals with ds. eeg and erp measure may also help to predict treatment outcome.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of trisomy 21 * age 24-48 months * able to walk independently across a room * uses at least 5 words / signs * english speaking * parent able to accompany participant to all study visits exclusion criteria: -diagnosis of mosaic / translocation down syndrome

Keywords: behavioral regulation emotional regulation social communication development
repeated partial sleep deprivation to augment ssri response in depression

Conditions: Depression

Summary: the purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.

depression is common and associated with social and economic costs. although antidepressant medications are an effective treatment for depression, it can take as long as 6-8 weeks before symptoms improve, and 20-35% of individuals who use antidepressants still experience depression symptoms. new treatments that accelerate response to antidepressants are important to reduce the burden of depression. the objectives of the proposed study are (1) to evaluate the effects of partial sleep deprivation compared to no sleep deprivation for improving response to 8 weeks of fluoxetine 20-40 mg treatment and (2) to examine the underlying sleep mechanisms of treatment response. participants who are eligible for the study will be randomly assigned to one of three sleep schedules for a 2-week period while taking fluoxetine: no sleep deprivation (8 hours time in bed), late bedtime (6 hours time in bed, with 2 hour bedtime delay) or early risetime (6 hours time in bed, with 2 hour advancement of rise time). participants will spend a total of 7 nights in our sleep laboratory and will be followed on fluoxetine for an 8-week period.

Eligibility criteria:
inclusion criteria: * between 18 and 65 years old * current major depressive episode * habitual tib of 7 to \< 10 hours * no antidepressant medications for ≥ 2 weeks (4 weeks for maois or longer acting antidepressants) * score of at least 18 on the hamilton rating scale of depression exclusion criteria: * alcohol or substance abuse/dependence in past 6 months * current posttraumatic stress disorder or bulimia nervosa (past 6 months) * lifetime history of bipolar i or ii disorder, schizophrenia/other psychotic disorder, and anorexia nervosa * trials of fluoxetine in the past 6 months * medical disorders or pain syndromes that may affect sleep or are associated with significant depression (e.g. thyroid or cushing's disease); history of head trauma with loss of consciousness of \> 5 minutes; history of seizures * sleep disorders other than insomnia, such as sleep apnea and periodic limb movement disorder * current use of prescription, over-the-counter, or naturopathic remedies for sleep (e.g., barbiturates, benzodiazepine agonists, nonbenzodiazepine hypnotics, analgesics) or depression (e.g., sam-e, st. john's wort) * currently working evening or midnight shift (subjects who have recently traveled across multiple time zones will be included at the discretion of the pi). * currently at risk for drowsy driving or employment that requires routine operation of transportation vehicles (e.g., truck/taxi driver, airline pilot) or hazardous equipment. * known allergy, hypersensitivity or contraindication to study medication * females: pregnant or nursing

Keywords: depression sleep treatment
study in adolescents/adults to evaluate the persistence up to 3.5 yrs of gsk biologicals meningococcal vaccine 134612

Conditions: Infections, Meningococcal

Summary: this study will investigate the long-term protection offered by gsk biologicals' meningococcal vaccine 134612 up to 3.5 years after vaccination. subjects were vaccinated at 15 to 19 years of age. this extension phase starts 18 months after vaccination and part of the subjects who were vaccinated in the primary study will be enrolled in this extension phase. no new subjects will be enrolled. this protocol posting deals with objectives \& outcome measures of the extension phase 18, 30 and 42 months after vaccination. the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct00126945). the protocol posting has been updated in order to comply with the fda amendment act, september 2007.

subjects were previously vaccinated at 15 to 19 years of age with gsk biologicals' meningococcal vaccine 134612 or with mencevax™ acwy. this extension phase starts 18 months after vaccination and part of the subjects will be enrolled in this extension phase. no additional vaccines will be administered during this study and no new subjects will be enrolled. the subjects will have three blood samples taken: at 18, 30 and 42 months after vaccination.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol. * a male or female, who was primed with meningococcal vaccine 134612 or mencevax™ acwy in the primary vaccination study 18 months before the first persistence assessment and who completed that study. * written informed consent obtained from the subject/ from the parent or guardians of the subject. * written informed assent obtained from the subject, as applicable, at the time of study entry. exclusion criteria: • administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since the last visit of the primary vaccination study.

Keywords: immunogenicity meningococcal vaccine conjugate vaccine persistence
low dose ct distal radius fractures

Conditions: Radius Fractures

Summary: this study is a prospective, departmental funded study examining the outcomes of low dose ct scans compared to conventional dose ct scans in patients who present to duke university with a distal radius fracture.

the purpose of this study is to compare the use of a conventional dose computed tomography scan (c-ct) to a low dose computed tomography scan (l-ct) in the assessment of articular displacement, and development of a treatment plan for intraarticular distal radius fractures in an effort to reduce the radiation exposure to future patients with this injury pattern. reviewers will be tasked with reporting data aimed at investigating 3 primary outcome measures: 1) are l-ct images of sufficient quality to be used for diagnostic purposes, 2) can accurate measurements of step and gap displacement be made on l-ct images, 3) do proposed treatment plans change with the use of l-ct relative to those chosen based on c-ct images we hypothesize that reviewers will find l-ct images of sufficient image quality for diagnostic purposes, measurements of step and gap displacement will not be significantly different between l-ct and c-ct, and no significant differences in treatment options will be chosen based on the use of l-ct rather than c-ct for the same fracture. the secondary aim will be to evaluate the interobserver and intraobserver reliability of l-ct in evaluating intraarticular fractures of the distal radius.

Eligibility criteria:
inclusion criteria: * subjects must be age 18 years or older. * subject must have sustained an intraarticular distal radius fracture which undergo closed reduction and application of a below-elbow splint. * subjects whos injury occurred less than 2 weeks prior to the time of enrollment. exclusion criteria: * subject is under the age of 18 years. * subject is unable to speak english for completion of consent process. * subject sustained pathologic fracture. * subject sustained open fracture. * subject is a pregnant woman.
a study on evaluating the safety of hst101 in healthy chinese participants

Conditions: Hypercholesterolemia; Healthy Volunteers; LDL-Cholesterol

Summary: this is a single-center, randomized, double-blind, placebo-controlled, single hst101 sc dose cohort study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy chinese participants with elevated ldl-c levels.

the planned 30 study participants will be assigned to low- or high-dose 2 cohorts and 15 participants in each cohort will be randomized to either the hst101 group or the matching dose placebo group and will be administered in subsequent or in-parallel manner. cohort 1: 15 study participants will receive the low dose of hst101 or placebo at a corresponding dose. cohort 2: additional 15 study participants will receive the high dose of hst101 or placebo at a corresponding dose.

Eligibility criteria:
inclusion criteria: * men and women who are ≥18 and ≤55 years of age with elevated ldl-c levels; * ldl-c ≥ 2.6 mmol/l (100 mg/dl) and ≤ 4.9 mmol/l (190 mg/dl) and tg ≤ 2.83 mmol/l (250 mg/dl) who are not on a lipid-lowering therapy 30 days prior to screening; * body mass index (bmi) ≥18 and≤28 kg/m2 exclusion criteria: * positive blood screen for hiv antibody, treponema pallidum antibody, hbsag or hcv antibody; * clinically significant liver function test abnormalities at screening, such as ast or alt \> 2 × uln, total bilirubin \> 1.5 × uln, or alp \> 2 × uln based on normal values; * ck \> 3 × uln at the screening visit, it can be retested if considered to be related to exercise; * history of prescription drug abuse, illicit drug use or alcohol abuse; * use of any prescription drug, herbal and compound decoction, vitamins, minerals, and otc drugs and nutritional supplements that alter lipid metabolism within 14 days prior to check-in and planned use of the above drugs throughout the study; * prior treatment with pcsk9 inhibitors, including mabs, sirna products, or any adnectin products; * history of allergy to protein-based biologics including, but not limited to, mabs and vaccine; * less than 30 days or less than 5 half-lives (drug) since the end of participation in another clinical trial (drug or device), whichever is longer; * use of any other biologics within 3 months prior to investigational product administration; * any other significant clinical diseases or psychological diseases that the investigator considers to be inappropriate for participation in this study.
action of synbiotics on irradiated gi mucosa in rectal cancer treatment

Conditions: Rectal Cancer

Summary: the aim of this study is to investigate how bacteria and fibre interact with the epithelial cells of the gastrointestinal mucosa to reduce inflammation and to diminish tissue damage caused by radiation therapy to patients diagnosed with rectal cancer.

thirty patients diagnosed with rectal cancer receiving short term radiation therapy 25 gray (gy) during one week preoperatively will be examined. the patients will be divided into three groups with ten patients in each group. one control group without no treatment/study product, one group receiving a test product of 45 g of oat bran and freezing medium only, and one group having a probiotic bacteria, lactobacillus plantarum heal 19 (1010 cfu/g), freezed dried blueberry husks (13 g) and oat bran (22 g), corresponding to 8 g fibre per day in each of the two treated groups. the patients will consume the test product once a day 1 week before and during radiotherapy (2 weeks in total). mucosal biopsies for microflora analysis and blood samples for analysis of scfas and cytokines will be collected at inclusion as well as faecal samples. after radiation therapy, at surgery, blood samples, faecal samples and mucosal biopsies are collected. fresh faecal samples, blood samples and mucosal biopsies are stored at -80°c until analysis.

Eligibility criteria:
inclusion criteria: * rectal cancer/adenocarcinoma recti * informed consent explained orally and written, understood, agreed and signed exclusion criteria: * diabetes mellitus * inflammatory bowel disease * previous radiation to pelvis area * ongoing steroid or immunosuppressive therapy * ongoing antibiotics therapy

Keywords: radiotherapy, probiotics
study of hypercortisolism in cushing's syndrome and stress-induced pseudo-cushing's syndrome

Conditions: Cushing's Syndrome

Summary: objectives: i. determine whether cushing's syndrome and stress-induced pseudo-cushing's syndrome can be differentiated by evaluating endogenous corticotropin-releasing hormone activity.

protocol outline: patients undergo a 30-hour infusion of deuterated cortisol with peripheral and petrosal vein measurements of adrenocorticotropin hormone (acth) and corticotropin-releasing hormone (crh). patients also have a 2-day, low-dose dexamethasone suppression test. patients with acth tumors are referred for pituitary surgery as indicated. patients without cushing's syndrome are entered as controls. during scheduled radiologic procedures, these subjects undergo acth and crh sampling from the petrosal vein or cavernous sinus following a deuterated cortisol infusion.

Eligibility criteria:
protocol entry criteria: suspected adrenocorticotropin hormone (acth)-dependent cushing's syndrome no pregnant women effective contraception required of fertile women

Keywords: cushing's syndrome endocrine disorders rare disease
efficacy and safety of cx516 in elderly participants with mild cognitive impairment.

Conditions: Mild Cognitive Impairment

Summary: glutamate is fundamentally involved in learning and memory. memory loss associated with mild cognitive impairment may be due to loss of glutamate receptors in the aging brain. there is evidence cx516 enhances brain activity by specifically targeting remaining glutamate receptors in the affected portions of the brain. this study will test the safety and efficacy of cx516 in the symptomatic treatment of participants with mild cognitive impairment.


Eligibility criteria:
inclusion criteria * clinical diagnosis of mild cognitive impairment * good general health with no additional diseases that would interfere with the study. exclusion criteria * any significant neurologic disease (other than suspected incipient alzheimer's disease), such as parkinson's disease, stroke, tia's, multi-infarct dementia, huntington's disease, head trauma, chronic cns infection. * history of major depression or another major psychiatric disorder within the past 6 months. * history of schizophrenia, mania or recurrent psychotic episodes. * history of alcohol or dsm iv-diagnosed substance abuse or dependence disorder within the past year. * history of blackout, epilepsy or seizures, or an abnormal eeg as judged by the investigator and considering the age of the participant. * any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or hematological illness or unstable medical condition which could interfere with drug safety, or absorption, distribution, metabolism and excretion, or lead to difficulty complying with the protocol.

Keywords: mild cognitive impairment memory loss alzheimer's disease brain aging ampalex® cx516
efficacy and safety of tislelizumab combined with bevacizumab and albumin paclitaxel in lung adenocarcinoma

Conditions: Lung Adenocarcinoma Stage IV

Summary: the single arm clinical study is to evaluate the efficacy and safety of tislelizumab combined with bevacizumab and albumin paclitaxel in the treatment of advanced lung adenocarcinoma. all of the patients were received egfr-tki therapy for 1 line and disease progression. the primary endpoint is six months pfs and safety, the seconday endpoint is orr and one-year os rate.

patients who meet the inclusion criteria will receive tislelizumab combined with bevacizumab and albumin paclitaxel for 4 cycles. if there is no disease progression, the patient will continue to receive tislelizumab maintenance therapy, until the disease progresses or death.

Eligibility criteria:
inclusion criteria: * lung adenocarcinoma stage ⅳ(according ajcc 8) * received egfr-tki for 1 line and disease progression * egfr t790m negative * ecog ps 0-2 exclusion criteria: * histology of mixed nsclc with squamous cell carcinoma, neuroendocrine carcinoma and small cell carcinoma. * have received checkpoint inhibitor. * uncontrolled pleural effusion, pericardial effusion, or ascites after appropriate intervention * any unstable systemic disease * patients who were treated with systemic glucocorticoids (\>10mg/ day prednisone therapeutic dose) or other immunosuppressive drugs within 14 days prior to the initial administration or during the study period
restoration of vision after stroke

Conditions: Stroke; Infarction; Posterior Cerebral Artery; Hemianopsia

Summary: occipital stroke is associated with homonymous visual field defects (occurring on one side of the visual field). despite spontaneous recovery, some degree of defect is often permanent. currently, no treatment exists for such visual field defects.the purpose of this study is to test the efficacy of a type of electrical brain stimulation method, transcranial alternating current stimulation, in reducing these type of visual field defects in their chronic stage.


Eligibility criteria:
inclusion criteria: * occipital ischemic or hemorrhagic stroke 6 months or older * hemianopia or quadrantanopia demonstrated by standard automated perimetry * visual field defect is stable across baseline * presence of residual vision and detectable gradual transition between the the intact and absolutely blind parts of the visual field * best corrected visual acuity for at least one eye better or equal to 0.4 exclusion criteria: * eye or central nervous system disease that interferes with the study * cardiac pacemaker * other metallic devices or implants precluding participation in mri scans * pregnancy or lactation period * epileptic seizures in the past 10 years * use of antiepileptic or sedative drugs * expected low compliance due to substance abuse * known active malignancy

Keywords: controlled clinical trial electric stimulation therapy
a study of eltrekibart and mirikizumab in adult patients with moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis; Ulcerative Colitis Chronic

Summary: the main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (uc).

the study will last approximately 4-5 years. screening is required within 35 days prior to enrollment. for each participant, the total duration of the clinical trial will be about 69 weeks including screening.

Eligibility criteria:
inclusion criteria: * have had an established diagnosis of uc of ≥3 months in duration before baseline. * have moderately to severely active uc as assessed by the uc disease activity score. * have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, janus kinase (jak) inhibitors, or sphingosine-1-phosphate (s1p) immunomodulators). * are on a stable dose of certain oral uc medications (including corticosteroids). * must meet contraception requirements. exclusion criteria: * have received anti-interleukin (il)-23p19 or anti-il-12p40 antibodies in the past. * have experienced a thrombotic event within 24 weeks before baseline. * have a current diagnosis of crohn's disease or certain other inflammatory gastrointestinal diseases. * have had certain abdominal surgeries within the past 3 months or are likely to require surgery for uc during the study. * have a history of certain adenomas, dysplasia's, or malignancies.

Keywords: cxcr1/2 ligand receptor antagonist il-23 p19 antibody gastrointestinal diseases inflammatory bowel diseases digestive system diseases colonic diseases intestinal diseases colitis colitis, ulcerative anti-inflammatory agents mirikizumab eltrekibart adult moderate to severe
treatment for reading and writing deficits following acquired brain injury

Conditions: Acquired Brain Injury; Alexia; Agraphia

Summary: many people with acquired brain injuries have deficits in reading decoding, reading comprehension, and written expression. alexia is a phenomenon in which a person who previously could read has trouble doing so after having sustained a brain injury; likewise, agraphia is an acquired writing problem affecting one or more aspects of written communication. alexia and agraphia sometimes co-occur with one another and/or with other language challenges, but they can also occur as isolated phenomena. methods to treat alexia and agraphia often focus on single intervention techniques that address aspects of reading or writing in isolation-such as matching written and spoken letters or letter sounds, performing choral reading, tracing letters, etc. existing research suggests that the effectiveness of these techniques is limited. however, when used in combination, such techniques may promote improved reading and written communication skills. as such, the purpose of this research is to determine the extent to which a multicomponent intervention program improves the reading and writing capabilities of people with acquired alexia and/or agraphia.


Eligibility criteria:
inclusion criteria: * survivor of acquired brain injury * exhibits alexia and/or agraphia * past or current client of quality living, inc., omaha, nebraska * fluent speaker of english exclusion criteria: * vision impairment prohibiting reading of 24-point text * auditory comprehension problems precluding understanding of consent/assent information