Kornimate/medical-research-clean huggingface dataset:
lactobacillus lozenges as preventative care in low-grade dysplasia

Conditions: Low-grade Oral Dysplasia

Summary: there are limited evidence-based management options for patients with low-grade oral dysplasia. despite the risk of malignant transformation, management is frequently limited to risk factor reduction (such as smoking cessation) and clinical surveillance. an intervention for low-grade oral dysplasia which could induce regression or decrease rates of malignant transformation has the potential to be a valuable preventative tool to reduce rates of oral cancer. the investigators will conduct a randomized clinical trial to investigate if the administration of a probiotic lozenge to patients with low-grade oral dysplasia result in decreased peri-tumoral inflammation as evidenced by impacts on populations of tumor-associated macrophages and tumor-infiltrating lymphocytes, and decreased dysbiosis at the disease site compared with the contralateral normal site. the investigators hypothesize that these changes may increase the rate of clinical regression of these lesions.


Eligibility criteria:
inclusion criteria: * presence of biopsy-proven low-grade or mild oral dysplasia exclusion criteria: * active oral cavity malignancy * active oral cavity high grade dysplasia * currently undergoing chemotherapy or immunotherapy, or have used these agents within the prior 6 months * history of external beam radiation therapy to the head and neck area * diagnosis of hiv with decreased cd4 count and/or detectable viral load * current use of systemic or orally absorbed steroids * patient undergoing stem cell transplantation * patients taking anti-rejection medication after stem cell or solid organ transplantation * patients using injectable immunosuppressive drugs for autoimmune disease * pregnant or nursing women * patients who are hospitalized * patients with a heart valve abnormalities or a history of valve replacement or endocarditis * patients with active severe acute intestinal disease (active bowel leak, acute abdomen, active colitis) or a history of short bowel syndrome

Keywords: probiotic lozenge oral cavity squamous cell carcinoma oral microbiome
a phase 3 study of barzolvolimab in participants with chronic spontaneous urticaria (csu)

Conditions: Chronic Spontaneous Urticaria

Summary: the purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with chronic spontaneous urticaria (csu) inadequately controlled by non-sedating second generation h1-antihistamines in comparison to placebo.

this is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with chronic spontaneous urticaria (csu) who are symptomatic despite treatment with non-sedating second generation h1-antihistamines at 1-4 times the locally approved dose. there is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period. approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.

Eligibility criteria:
key inclusion criteria: 1. males and females, \>/= 18 years of age. 2. chronic spontaneous urticaria (csu) \>/= 6 months prior to screening (visit 1). 3. csu despite the use of a stable regimen of second generation non-sedating h1-antihistamine as defined by: 1. the presence of hives for \>/= 6 weeks at any time prior to visit 1 despite the use of non-sedating h1-antihistamines. 2. must be on a stable regimen of second generation non-sedating h1-antihistamine for \>/= 4 weeks prior to study treatment. 3. uas7 of \>/= 16 and iss7 of \>/= 8 during the 7 days prior to study treatment. 4. normal blood counts and liver function tests. 5. both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment. 6. willing and able to complete a daily symptom electronic diary and comply with study visits. 7. participants with and without prior biologic experience are eligible. key exclusion criteria: 1. women who are pregnant or nursing. 2. chronic urticaria whose predominant manifestation is due to cindu. 3. other diseases associated with urticaria. 4. active pruritic skin condition in addition to csu. 5. medical condition that would cause additional risk or interfere with study procedures. 6. known hiv, hepatitis b or hepatitis c infection. 7. vaccination of a live vaccine within 30 days prior to screening (visit 1) (subjects must agree to avoid live vaccinations during the study). inactivated vaccines are allowed such as seasonal influenza injection or authorized covid-19 vaccine. 8. history of anaphylaxis 9. prior treatment with barzolvolimab there are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Keywords: cdx-0159 barzolvolimab chronic spontaneous urticaria csu urticaria activity score itch severity score hives severity score
knowledge and interpersonal skills to develop exemplary relationships (kinder): pilot study

Conditions: Dementia; Caregiver Burden; Relation, Family; Elder Abuse

Summary: the purpose of this study is to determine the feasibility and acceptability of delivering the kinder intervention to family caregivers to persons living with dementia. further, the investigators will examine the preliminary efficacy of the kinder intervention at improving caregiver resourcefulness, relationship quality, and quality of care, including reduction of potential verbal-type elder mistreatment. during this study, participants will be asked to complete two (2) 30- to 45-minute surveys asking about their demographic information, caregiving situations, and relationship with the care recipient. the first survey will be sent within two weeks of beginning the kinder intervention, the second will be sent within one week after participants complete the kinder intervention so we can compare outcomes.


Eligibility criteria:
inclusion criteria: * is age 18+ * provides care to a family member or friend living with alzheimer's disease or a related dementia. * helps with at least 1 activity of daily living (e.g., bathing) or 2 instrumental activities of daily living (e.g., shopping) * provides at least 8 hours of assistance to the care recipient per week * does not intend to place the care recipient in a skilled nursing facility within 3 months of consenting into the study exclusion criteria: * does not read and speak english * cannot reliably access a computer and internet
effect of mediterranean diet during pregnancy on the onset of overweight and obesity in the offspring

Conditions: Food Allergy

Summary: the first 1,000 days of life, from the conception to 24 months, are crucial to achieve long-term health outcomes and represent a strategic period to intervene under prevention and public health perspective. nutritional exposures during this critical period of life can influence the future disease susceptibility. maternal diet during pregnancy has been linked to offspring overweight/obesity risk and it could represent a potential target for overweight/obesity prevention. the mediterranean diet (md) is considered one of the healthiest dietary models, which impacts beneficially the gut microbiome (gm), providing high amounts of fiber, antioxidants polyphenols and vitamins, and a balanced ratio of essential fatty acids (ω6:ω3). notably, the md beneficial effects are due to the synergistic and interactive combinations of nutrients, and the modulation of gene expression through epigenetic changes. unofrtunately, the md mechanisms during pregnancy in the prevention of childhood overweight/obesity are not yet fully known.

the premedi study has been designed to evaluate the effects of mediterranean diet during pregnancy on the occurrence of overweight/obesity at 24 months in the offspring.

Eligibility criteria:
inclusion criteria: * women * caucasian ethnicity * aged between 20 and 35 years exclusion criteria: * proven presence of infections during pregnancy and at delivery, * twin pregnancy, * ongoing malignancies, * major gastrointestinal tract malformations, * immunodeficiencies, * diabetes and other chronic diseases at each organ or apparatus level, * chronic intestinal inflammatory diseases, * gastrointestinal function disorders, * celiac disease; * history of abdominal surgery with intestinal resection, * neuropsychiatric disorders, * central nervous system disorders, * vegan diet.
pharmacokinetics of propofol in morbidly obese patients

Conditions: Obesity, Morbid

Summary: the objectives of this study are * to determine pk of propofol in bariatric patients * to identify the physiological variables that induce propofol pk changes in bariatric patients, when compared to a normal-weight population. * to define context-sensitive half-time profiles for propofol in bariatric patients.


Eligibility criteria:
inclusion criteria: * consecutive patients admitted to the aker university hospital, scheduled for general or bariatric surgery, * both genders. female subjects of childbearing potential must be using adequate contraception (i.e. using oral or im contraception or an iucd) and must have a negative pregnancy test (urine beta-hcg). * aged 18 - 60 years, both inclusive * body mass index (bmi) ≥ 20 kg/m2 * written informed consent exclusion criteria: * patients that are considered not to tolerate a standard dose of propofol administered as a bolus. * known hypersensitivity to propofol or its ingredients (soy, lecithin, glycerol, oil acid) * known hypersensitivity to any of the anesthetic agents to be used * pregnant women * lactating women

Keywords: bariatric surgery anesthetics, intravenous propofol pharmacokinetics
efficacy and safety of adalimumab in patients with active rheumatoid arthritis treated concomitantly with methotrexate.

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension phase) in patients with persistently active rheumatoid arthritis who were receiving concurrent methotrexate therapy.

this was a 10-year study which had an initial 52-week, double-blind, placebo-controlled phase followed by an open-label extension phase up to 9 years in duration. data were analyzed for the double-blind phase using all patients who were randomized and received at least one dose of study drug through week 52 and for all patients who received at least one dose of adalimumab during the 10-year study (the intent-to-treat \[itt\] population).

Eligibility criteria:
inclusion criteria: * age 18 or older and in good health (investigator discretion) with a recent stable medical history * met american college of rheumatology (acr) criteria for diagnosis of active rheumatoid arthritis (ra) and had at both screening and baseline visits \>=6 swollen joints and \>=9 tender joints, despite a minimum of 3-months treatment with methotrexate (mtx). (distal interphalangeal joints \[dips\] were not to be included in joint count for inclusion. the screening and baseline visits could be 3 to 28 days apart for patients not previously receiving disease-modifying anti-rheumatic drugs \[dmards\] other than mtx or 4 to 6 weeks for patients requiring a dmard washout period.) * insufficient efficacy with mtx 12.5 to 25 mg per week (10 mg per week if mtx intolerant). * if patient on a second-line treatment (dmard) other than mtx, he/she had to discontinue it for at least 28 days before the baseline visit (the washout period). * treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin per week. * both rheumatoid factor positivity and a c-reactive protein value \>=1 mg/dl, or at least one joint erosion on x-ray. exclusion criteria: * subject considered by the investigator, for any reason, to be an unsuitable candidate for the study. * female subject who was pregnant or breast-feeding or considering becoming pregnant. * preceding treatment with any tumor necrosis factor (tnf) antagonist, including adalimumab. * prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide. * intra-articular, intramuscular, or intravenous administration of corticosteroids within 4 weeks prior to the screening visit. * subject was wheelchair bound or bedridden.

Keywords: rheumatoid arthritis
ifx-hu2.0 expanded access program

Conditions: Cutaneous Melanoma, Stage III; Cutaneous Melanoma, Stage IV; Merkel Cell Carcinoma; Cutaneous Squamous Cell Carcinoma

Summary: expanded access requests for ifx-hu2.0 may be considered for the treatment of adult patients (greater than or equal to 18 years of age) with stage iii through iv cutaneous melanoma, advanced merkel cell carcinoma (mcc), or advanced cutaneous squamous cell carcinoma (cscc) who have failed all available treatment options. to request access, use responsible party contact information provided in this record..


Eligibility criteria:
inclusion criteria: * to request more information use responsible party contact information provided in this record exclusion criteria: * to request more information use responsible party contact information provided in this record

Keywords: cm mcc cscc pdna plasmid dna pac/emm55 ifx-hu.20 immunotherapy gene therapy immunology oncology immuno-oncology
individual patient exposure and response in pediatric lupus

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this research study is to see if an electronic pill bottle cap can help children and teens with systemic lupus better remember to take their medicine. it will also gather information on the best dose of hydroxychloroquine (plaquenil®) for children and teens. participants in this study will continue to take their usual medication as prescribed by their doctors. participants will receive an electronic pill bottle cap, a smartphone, and a fitbit. over 6 months, a nurse will visit each participant 4 times to ask questions about symptoms, draw blood, and take a urine sample. after the study, participants will be able to keep the electronic pill bottle cap and fitbit, but will return the smartphone.

this is an exploratory phase 2, single site, open-label, direct-to-family, adherence and exposure-response study of hydroxychloroquine (hcq) in pediatric systemic lupus. the study will measure a participant's adherence to hcq self-administration using an electronic pill bottle cap that records date/time of bottle opening and provides participants with a reminder when a dosage is due and/or missed. all participants will be provided with the electronic pill bottle cap to use with their regular hcq prescription at the start of the study. for the first 2 weeks of the trial, the electronic notifications will be disabled to determine a baseline measure of adherence. within 1 day after visit 2, the electronic notifications will be turned on for all participants, resulting in a series of alerts (via electronic pill bottle cap alerts and smartphone push notifications, text message, and/or automated phone calls). participants will continue to receive notifications via the electronic pill bottle cap through visit 4. throughout the study, participants will undergo a series of blood draws and urinalysis collections, and be asked to complete various questionnaires.

Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent form and assent, when necessary 2. age 5-17.5 years at consent 3. enrolled in the carra registry with a diagnosis of systemic lupus erythematosus as documented in the carra registry 4. receiving hydroxychloroquine as standard of care for ≥ 3 months 5. participant and caregiver primary language of english 6. willing and able to comply with study procedures, at the discretion of the study principal investigator 7. access to internet exclusion criteria: there are no pre-defined exclusion criterion for this trial.

Keywords: hydroxychloroquine virtual trial
sv2 pet imaging with [11c]app311

Conditions: Schizophrenia and Other Psychotic Disorders; Cannabis Use Disorder; Healthy

Summary: the aim of this study is to evaluate a new sv2a tracer, \[11c\]app311, in healthy aging and neuropsychiatric disorders including psychotic disorders and cannabis use disorders.

the overall goal of this protocol is to study synaptic density in two psychiatric disorders (namely schizophrenia and other psychotic disorders, and cannabis use disorder) with this exciting new pet tracer. secondary outcomes will include electroencephalography (eeg). a battery of eeg paradigms assessing sensory, perceptual, and cognitive functions will also be administered. the primary dependent measures will be traditional event related potentials (erps; e.g. latency and amplitude) as well as time x frequency analysis (inter-trial coherence and spectral power).

Eligibility criteria:
inclusion criteria: * willing and able to give voluntary written informed consent * male and female subjects, age 18 to 65 years, inclusive exclusion criteria: * mri metal exclusions and claustrophobia. * education completed is less than 12 years
efficacy of an erector spinae plane block in vats/rats

Conditions: Pain, Postoperative; Post-Op Complication

Summary: this study aims to study the analgesic and respiratory effects of the erector spinae plane block for patients undergoing video-assisted thoracic surgery (vats) or robotic assisted thoracic surgery (rats).

a total of 120 subjects will be randomized into three groups (30 per group). arm a: iv pcia arm b: iv pcia + ultrasound guided erector spinae block (espb, single shot of 30ml of 0.5% solution of naropin \[ropivacaine\]) arm c: iv pcia + multilevel intra-thoracic intercostal nerve block (icb, single shot of 30ml of 0.5% solution of naropin \[ropivacaine\]) pcia pumps for all study cohorts will be programmed according to our institution's standard protocol (dipidolor \[piritramide\] bolus: 2mg, interval: 7 min, max 4h dose: 30mg). the erector spinae block will be placed preoperatively, the intercostal block will be placed at the beginning of the procedure. all patients will receive standard postoperative care. the patients will be blinded for the study arm. the primary endpoint of this study is postoperative pain and will be recorded by using the numerical rating scale (nrs) pain score. pain scores will be measured by the investigator at rest and during coughing. opioid consumption will be monitored and registered for.

Eligibility criteria:
inclusion criteria: * male and female patients * age between 18 to 100 years old * asa 1-3 * scheduled for vats * informed consent explained and signed exclusion criteria: * patients \ 100 years old * asa physical status \> 3 * previous cardiac surgery or ipsilateral thoracic surgery * neuropsychiatric diseases * allergy to analgesics or local anesthetics or other medications used in the study * abuse of opioids or sedatives * contraindication to receive regional anesthesia (e.g. coagulation defect) * patients who could not understand the vas pain-scoring system * patient refusal to follow participation * expected post operative mechanical ventilation * intolerance or allergy to any prescribed medication
clinical usefulness of optical skin biopsy

Conditions: Skin Neoplasms

Summary: traditional biopsy requires the removal, fixation, and staining of tissues from the human body. its procedure is invasive and painful. non-invasive in vivo optical biopsy is thus required, which should provide non-invasive, highly penetrative, three-dimensional (3d) imaging with sub-micron spatial resolution. optical biopsy based on scanning two-photon fluorescence microscopy (tpfm) is a good method for biopsy of skin due to its high lateral resolution, low out-of-focus damage, and intrinsic three-dimensional (3d) section capability. however current technology still presents several limitations including low penetration depth, in-focus cell damages, and multi-photon phototoxicity due to high optical intensity in the 800 nm wavelength region, and toxicity if exogenous fluorescence markers were required. we study the harmonics optical biopsy of a human skin sample using a femtosecond cr:forsterite laser centered at 1230 nm. higher harmonics generation is known to leave no energy deposition to the interacted matters due to their energy-conservation characteristic. this energy-conservation characteristic provides the "noninvasive" nature desirable for clinical imaging. in our study, we will evaluate the clinical applications of optical skin biopsy using harmonic generation microscopy.

traditional biopsy requires the removal, fixation, and staining of tissues from the human body. its procedure is invasive and painful. non-invasive in vivo optical biopsy is thus required, which should provide non-invasive, highly penetrative, three-dimensional (3d) imaging with sub-micron spatial resolution. optical biopsy based on scanning two-photon fluorescence microscopy (tpfm) is a good method for biopsy of skin due to its high lateral resolution, low out-of-focus damage, and intrinsic three-dimensional (3d) section capability. however current technology still presents several limitations including low penetration depth, in-focus cell damages, and multi-photon phototoxicity due to high optical intensity in the 800 nm wavelength region, and toxicity if exogenous fluorescence markers were required. we study the harmonics optical biopsy of a human skin sample using a femtosecond cr:forsterite laser centered at 1230 nm. higher harmonics generation is known to leave no energy deposition to the interacted matters due to their energy-conservation characteristic. this energy-conservation characteristic provides the "noninvasive" nature desirable for clinical imaging. in our study, we will evaluate the clinical applications of optical skin biopsy using harmonic generation microscopy.

Eligibility criteria:
inclusion criteria: * skin lesions admitted for surgical resection. exclusion criteria: * none
risk factors for delirium in critically ill surgical patients

Conditions: Delirium; Intensive Care Unit Syndrome

Summary: delirium is characterized by changes in mental status, inattension, disorganized thinking, and altered consciousness. prevalence of delirium in critically ill patients has varied from 20\~80% depending on the severity of illness. despite its high prevalence, delirium is often under-recognized by clinicians due to the difficulties in diagnosis and no interest. delirium is associated with increased mechanical ventilation days, hospital length of stay, and mortality. the purpose of this study is to analyze the prevalence of delirium and risk factors for delirium in critically ill surgical patients.

the investigators performed a prospective cohort study involving the patients admitted to surgical icu between april 2013 and august 2013. the included patients were assessed independently by trained icu nurses using the confusion assessment method for the icu (cam-icu). the patients were recorded general characteristics, disease-related factors, and treatment and environment-related factors. data were analyzed by spss 12.0 software, using t-test, fisher's exact test and logistic regression.

Eligibility criteria:
inclusion criteria: 1. above rass -3 paitent 2. verbally or nonverbally communication possible patients exclusion criteria: 1. under age 18 2. neurological disorder e.g.) brain injury, dementia and traumatic brain injury 3. readmitted to icu 4. history of delirium 5. transplanted; isolation is required

Keywords: delirium intensive care unit