Kornimate/medical-research-clean huggingface dataset:
low-level light therapy on treatment of venous ulcers assesed by nursing outcome classification (noc)

Conditions: Venous Ulcer; Low-Level Light Therapy

Summary: this study compares the effect of adjuvant treatment of low-level light therapy with conventional treatment in the tissue repair of venous ulcers in patients undergoing outpatient nursing consultation. for the evaluation of the cases clinical indicators of nursing outcomes classification have been used.

there are several therapeutics with different mechanisms of action to reach tissue repair. the conventional treatment of venous ulcers is based on the alternation of exercising the lower extremities with resting, the application of topical treatments associated with compressive therapy, and the use of medications. despite the diversity of bandages available, there are still lesions with difficult prolonged healing process. therefore, low-level light therapy has been used as an adjuvant technological alternative therapy, due to its photochemical effects on the tissues, such as the modulation of inflammation, increase of granulation tissue, contraction of the wound, reduction of the inflammatory process, and reduction of pain. this therapy contributes to accelerate and improve the tissue repair process. studies assessed by nursing outcomes classification about the usage of the treatments above combined are not available. consequently, more robust clinical studies over venous ulcers to evaluate the tissue repair must be proposed using reliable instruments.

Eligibility criteria:
inclusion criteria: * presence of venous ulcer * availability for weekly appointment * acceptance to participate of the research with the signature of the term of free and informed consent exclusion criteria: * morbid obesity * active cancer treatment * erysipelas * cellulitis, lymphangitis and chronic lymphedema * usage of immunosuppressants and / or corticosteroids * venous ulcer all around the leg * presence of coagulation necrosis covering more than 25% of the wound bed.

Keywords: wound healing outcome assessment (health care)
safety, tolerability and systemic pharmacokinetics of agn-232411 in healthy participants and participants with dry eye

Conditions: Healthy Volunteers; Dry Eye Syndromes

Summary: this study will examine the safety, tolerability, and systemic pharmacokinetics of up to 3 different concentrations of agn-232411 topical ophthalmic solution in healthy participants and participants with dry eye.


Eligibility criteria:
inclusion criteria: stage 1 -healthy participants. stage 2 -participants with the symptoms of dry eye disease. exclusion criteria: stage 1 -known allergies or sensitivities to study medications, fluorescein, or lissamine green stage 2 * known allergies or sensitivities to study medications, fluorescein, or lissamine green * allergic ocular disease, ocular trauma, corneal erosions or ulcers, or uveitis within the previous 12 months * history of any ocular surgery within the previous 12 months.
custom foot orthoses & venous status

Conditions: Foot; Foot Orthoses; Photoplethysmography; Venous Stasis

Summary: the purpose of the research is to compare the influence of customized foot orthoses use on the venous status among healthy female and male subjects. this is a quasi-experimental study which included 20 healthy subjects. sociodemographic and medical record data are registered. furthermore,venous function is evaluated by plethysmography, first, without orthoses and, after 20 days, with orthoses.


Eligibility criteria:
inclusion criteria: * healthy subjects. exclusion criteria: * prior diagnosed conditions such as neurological, vascular or traumatic disorders.
upgrade the grains study: increasing whole grain consumption in low-income children with obesity

Conditions: Obesity

Summary: this study will assess the impact of a randomized intervention aimed at increasing consumption of whole grain foods among children from low-income households that participate in the special nutrition assistance program (snap, or "food stamps"). a total of 60 obese children (8 to 16 years) will be recruited from a clinical population (healthy eating active living program) at university of california san francisco (ucsf) benioff children's hospital oakland. participants and their caregivers will all receive education about whole grain foods, and will be randomized to either an intervention or control group. the intervention group will receive a monthly reimbursement allotment of up to 10% of their usual snap benefit for specific whole grain foods purchased during the three month study period. the control group will not have the financial incentive for purchasing whole grain foods during the 12 week study period. the investigators will assess the feasibility of the intervention, the impact of the intervention on household grocery purchases, and the impact on the child's anthropometrics, dietary intake of whole grain foods (24-hour recall), and markers of metabolic risk.

run-in phase (weeks -4 to 0) * participants will participate in a "run-in phase" where they will be asked to keep all grocery receipts for a 4 week period randomization (week 0) * child participants with caregivers who are able to successfully complete the run-in phase are then randomized at that point to be either in the intervention arm or the control arm. * patients will be block randomized by age group (8-11 and 12-16). active phase (weeks 0-12) * participants will be given education about whole grains and whole grain preparation. intervention and control participant activities described elsewhere. return visit (week 24) * 12 weeks after the completion of the active phase of the study, patients will be asked to return for a final visit at the research center, during which they will also have blood tests and other study activities repeated for one final time.

Eligibility criteria:
inclusion criteria: * obese (bmi greater than 95th percentile for age and gender) * low-income family currently participating in snap ("food stamps") * participant and caregiver speaks either english or spanish exclusion criteria: * medications to lower lipid levels (statins), which would affect insulin sensitivity (e.g. metformin, abilify) or which are known to affect serum cholesterol (e.g. carbamazepine). * type ii diabetes
pet/ct in diagnosing patients with liver cancer undergoing surgical resection

Conditions: Adult Hepatocellular Carcinoma; Localized Resectable Adult Liver Carcinoma

Summary: this clinical trial studies positron emission tomography (pet)/computed tomography (ct) in diagnosing patients with liver cancer undergoing surgical resection. diagnostic procedures, such as fluorine-18 fluoromethylcholine pet/ct, may help find and diagnose liver cancer.

primary objectives: i. determine the most optimal fluorine-18 (18f) fluoromethylcholine (fch) pet/ct parameters for detecting primary hepatocellular carcinoma (hcc) by conducting a clinical radiologic-pathologic correlation study to estimate and compare the receiver operating characteristics of kinetic and static pet measures of tumor fch metabolism in patients that test positive during screening or conventional imaging. ii. identify cancer signaling pathways associated with choline metabolism in hcc by profiling the global gene expression patterns in fresh-frozen liver tissue samples that are correlated with the features derived from fch pet/ct images. iii. characterize the association between features derived from fch pet/ct images of the liver and clinical liver disease severity and comparatively evaluate the ability of corresponding gene expression signatures to predictively model hcc disease outcome. outline: patients undergo 18f-fluoromethylcholine pet/ct within 14 days of surgical resection. after completion of study treatment, patients are followed up periodically.

Eligibility criteria:
inclusion criteria: * liver tumor diagnosed histologically as hcc or suspected of being hcc in association with serum alpha-fetoprotein level \> 200 or tumor mass with characteristics of malignancy on diagnostic imaging * under the care of a surgical attending * deemed a surgical candidate and has agreed to surgery to remove a portion of the liver containing tumor * child-pugh a/b exclusion criteria: * weight \> 350 lbs * pregnant or lactating female, a serum pregnancy test will be performed within 2 weeks or less before the date of the fch pet/ct scan in all women capable of becoming pregnant * serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure * concurrent treatment with chemotherapy, molecule-selective, biological, or radiotherapeutic agent
assessment of the safety of adalimumab in rheumatoid arthritis patients showing rapid progression of structural damage of the joints, who have no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents

Conditions: Rheumatoid Arthritis

Summary: this study was conducted to examine the safety profile and the effectiveness in daily clinical practice of adalimumab in rheumatoid arthritis participants showing rapid progression of structural damage of the joints, who had no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.

this was a multicenter, prospective, observational study of adalimumab. each participant enrolled when initiating adalimumab treatment and was to be followed up for 24 weeks or until discontinuation of the drug.

Eligibility criteria:
inclusion criteria: 1. high disease activity, with poor prognostic factors (e.g., rheumatoid factor \[rf\]-positive, anti-cyclic citrullinated peptide \[ccp\] antibody-positive, or bone erosion) 2. combination of adalimumab and methotrexate will be started 3. no prior history of treatment with disease-modifying anti-rheumatic drugs 4. no prior history of treatment with biological agents 5. adalimumab dosed according to the registered product label 6. signed informed consent exclusion criteria: there were no specific exclusion criteria.

Keywords: rheumatoid arthritis
role of pet/ct with fluorine-18 tracers of bone metastases in prostate cancer

Conditions: Prostate Cancer

Summary: compare pet/ct and mri for the early detection of bone metastases of prostate cancer: diagnostic performance and impact on the patient management.determine the lowest cost strategy according to the precise clinical circumstances.

in patients with high risk prostate cancer and high psa levels, pet/ct with fluoride (18f) and fluorocholine (18f) and whole-body mri will be performed within one month. data of a 6 month follow-up after those examination will be made available to a panel of independent experts. they will determine the standard of truth (sot) concerning the invasion of the skeleton and also of soft tissue by prostate cancer tissue, the impact of each imaging modality on patient management and the adequacy of the decisions. in some cases (anti-hormone treatment without histology), it will not be possible to determine the sot. by comparison of the results of blind readings for each imaging modality with the standard of truth, the diagnostic performance will be determined. by simulation, several strategies will be constructed concerning the best examinations to be performed and the sequence according to the precise clinical circumstances. their cost and effectiveness will be evaluated.

Eligibility criteria:
inclusion criteria: * age \> 18 * histologically proven prostate cancer. * abnormal plasmatic level of prostate specific antigen dating less than 3 months, initial gleason score available * written informed consent. exclusion criteria: * other active cancer or bone infection. * chemotherapy or change in hormone therapy since the last psa assay * contraindication to mri without contrast agent (claustrophobia, pace maker, metallic foreign body, some cardiac valves). metallic joint prostheses are not a contraindication. * allergic reaction to radiopharmaceuticals that will be used. * patient who seems not capable of staying in the gantry of the machines during the examinations without moving.

Keywords: comparison of imaging modalities impact on patient management optimisation of cost of the diagnostic strategy
a retrospective study on epidemiological characteristics of chinese nf1 patients in real world (promise)

Conditions: Neurofibromatosis 1; Plexiform Neurofibroma

Summary: background/rationale: neurofibromatosis type 1 (nf1) affects about 1 in every 3000 people worldwide. globally, 30\~50% nf1 patients will develop plexiform neurofibromas (pns), which grow rapidly in early childhood and can cause disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder and bowel dysfunction. this systemic disease imposes a heavy psychosomatic and financial burden on patients and their caregivers. in nf1 patients, the lifetime risk of mpnst developed from pn is 8% to 13%. the mean age for nf1-associated death was approximately 20 years lower than that for the general population. limited epidemiological and clinical data of chinese nf1 patients is available to date. and the treatment pattern of chinese nf1-pn patients is also unknown. objectives and hypotheses: it is a descriptive study without formal hypothesis. the primary objective of this study is determining the percentage of nf1 patients who develop pn. the secondary objectives of this study include describing the clinical characteristics, tumor progression and treatment pattern of nf1-pn. the exploratory objective is exploring the epidemiological characteristics of other nf1 manifestations. methods: study design: the study is a retrospective multi-center chart review study. data source(s): all the data will be collected by crf from inpatient and outpatient electronic medical records in every study site from january 1, 2019 to december 31, 2022. study population: patients who attended the study sites between january 1, 2019 - december 31, 2022 and were diagnosed with nf1 were included in this study. statistical analysis: this study is purely descriptive without any formal hypotheses. missing data for baseline characteristics will be assessed and addressed as a categorical variable with a level for missingness. all reported measures will be summarized in the study tables. point estimates and their 95% cis will be presented in the final analyses.


Eligibility criteria:
inclusion criteria: 1. patients who attended the study sites between january 1, 2019, and december 31, 2022. 2. patients who were diagnosed with nf1(recorded with the text of type i neurofibromatosis) based on national institutes of health (nih) nf1 consensus. exclusion criteria: 1. patients combined with other malignant tumors
pressure wire compared to microcatheter-based sensing technology for the evaluation of ffr measurements

Conditions: Ischemia; Angina

Summary: the model by which physicians measure the lack of blood flow in the vessels that supply blood to the heart muscle is called fractional flow reserve (ffr). ffr is the measurement of the pressure across the vessels that supply blood to the heart. these are known as the coronary arteries. this study involves comparing two ffr wires, the st. jude medical pressure wire (pw) and the acist navvus microcatheter (mc) to check the accuracy of the devices. ffr allows real-time estimation of the effects of a narrowed vessel, whereas standard angiography can underestimate or overestimate narrowing, because it only visualizes contrast (the different areas of color) inside a vessel.

fractional flow reserve (ffr) measurement by pressure wire (pw) under hyperemic conditions has become the invasive gold standard for determining the physiologic extent of cardiac ischemia, and which has been validated in several clinical outcomes studies as a way of optimizing case selection for percutaneous coronary intervention (pci). more recently a microcatheter (mc)-based sensor measurement of fractional flow reserve has been introduced. small scale in-vivo comparisons have been performed suggesting the utility of this approach to measure ffr,but these data are limited and have not been independently validated. this non-randomized, prospective study is designed to evaluate the accuracy of mc-based ffr measurement to the pw standard in lesions subjected to ffr assessment in routine clinical practice.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. patient provides signed written informed consent before any study-specific procedure. 3. undergoing coronary angiography, for silent ischemia, stable angina, acute coronary syndrome, or other acceptable indication per the local standard of care. 4. angiographically significant (\>50% visual estimation) stenosis present in at least one native coronary artery. 5. undergoing ffr assessment for standard clinical or diagnostic indications exclusion criteria: 1. aorto-ostial lesion location within 3 mm of the aorta junction (both right and left). 2. vessel(s) and lesion(s) not amenable for pci, for example diffuse disease. 3. currently participating in another clinical study that interferes with study results. 4. pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. 5. any other medical condition that in the opinion of the investigator will interfere with patient safety or study results. 6. high degree a-v block, sinus node disease. 7. known hypersensitivity to adenosine

Keywords: ischemia fractional flow reserve stent
improving outcomes for care partners of persons with traumatic brain injury

Conditions: Caregivers

Summary: care partners of persons with traumatic brain injury (tbi) are often faced with considerable physical and emotional stress resulting from their caregiver role. the researchers hypothesize that the care partners who receive the intervention will show improvements in caregiver strain and mental health.


Eligibility criteria:
inclusion criteria: * be caring for an adult (age 18 or above) with a medically documented tbi that is ≥1-year post-injury and meets the tbi model systems (tbims) criteria for complicated mild, moderate or severe tbi and who sustained their tbi at age 16 or older * provide emotional, physical, and/or financial support/assistance to the individual with the tbi, indicating a response ≥1 to the following question: "on a scale of 0-10, where 0 is "no assistance" and 10 is "assistance with all activities", how much assistance does the person you care for require from you to complete activities of daily living due to problems resulting from his/her tbi? activities could consist of personal hygiene, dressing and undressing, housework, taking medications, managing money, running errands, shopping for groceries or clothing, transportation, meal preparation and cleanup, remembering things, etc." * have access to necessary resources for participating in a technology-based intervention (smartphone/tablet and internet access) and be willing to use their personal equipment/internet for this study, including downloading the study app and the fitbit® app on their mobile device * is able and willing to complete all study assessments for the duration of their study participation (approximately 375 days) exclusion criteria: * is a professional, paid caregiver (e.g., home health aide) * anything that would preclude safe or meaningful participation in the study

Keywords: stress anxiety depression
a phase i study of tq-b3139 on tolerance and pharmacokinetics

Conditions: Advanced Cancer

Summary: a study of tq-b3139, inhibitor of alk/c-met tyrosine kinase, in patient with advanced cancer

phase i of safety, pharmacokinetic and pharmacodynamic study of tq-b3139. to recommend a reasonable dose and indication for subsequent research.

Eligibility criteria:
inclusion criteria: * histological documentation of advanced solid tumors * lack of the standard treatment or treatment failure * 18-65years,ecog ps:0-1,life expectancy of more than 3 months * patients with anti-treatment or surgery within 4 weeks * main organs function is normal * women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped * patients should participate in the study voluntarily and sign informed consent exclusion criteria: * patients participated in other anticancer drug clinical trials within 4 weeks * blood pressure unable to be controlled(systolic pressure\>140 mmhg，diastolic pressure\>90 mmhg). patients with grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including qt≥470ms) * patients with non-healing wounds or fractures * patients with drug abuse history and unable to get rid of or patients with mental disorders * history of immunodeficiency * patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
hellenic registry of ovation alto™ abdominal stent graft system

Conditions: Abdominal Aortic Aneurysm

Summary: this is a hellenic registry including both retrospective and prospective subjects receiving the ovation alto™ abdominal stent graft system ("ovation alto™ abdominal stent graft system post-market study") in the treatment of abdominal aortic aneurysms (aaa). the ovation alto™ hellenic registry is intended to expand the clinical knowledge base by collecting data on subjects treated with the ovation alto™ abdominal stent graft system in actual clinical practice during the first post-operative year.


Eligibility criteria:
inclusion criteria: * subject is \> 18 years of age * both ifu and non-adherence to ifu * subject intends to electively receive the ovation alto™ abdominal stent graft system * subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan exclusion criteria: * subject's current participation in a concurrent randomized control trial (rct) or investigational device/drug study which could confound study results. * life expectancy less than 1 year * pregnancy * subjects with poor renal function as indicated by a serum creatinine \> 2.5mg/dl.

Keywords: evar endovascular aneurysm repair ovation alto