Kornimate/medical-research-clean huggingface dataset:
the effect of seaweed derived polyphenols on inflammation and oxidative stress in vivo - the swafax study

Conditions: Cardiovascular Disease

Summary: cardiovascular disease (cvd) is currently the leading cause of death worldwide. epidemiologic studies have shown a diet rich in plant food protects against chronic degenerative diseases especially cardiovascular disease. many of these studies have highlighted a potential role for phenolic compounds, which are abundant secondary plant metabolites, and which provide antioxidant and anti-inflammatory properties and are increasingly being shown to have an important role in influencing critical cell signalling pathways. a less well known, but nevertheless rich source of polyphenolic compounds is seaweed. in ascophyllum nodosum, a common brown alga in the british isles, polyphenols have been reported to comprise up to 14% of the dry weight of the plant. some studies suggest that the potential antioxidant and anti-inflammatory benefits of seaweed-derived polyphenols may yield highly bioactive components with commercial potential for food and pharma applications. preliminary work in our laboratory has revealed potent antioxidant activity of ascophyllum nodosum extracts. therefore, the aim of this randomised, double-blind, placebo controlled, crossover design study is to investigate the biological activity of a food grade seaweed polyphenol extract in terms of reducing oxidative damage to dna, modulation of inflammatory responses and reduction on chronic, low level inflammation in vivo. apparently healthy volunteers (aged 30-65 years) will be randomised to receive either a capsule containing 100mg seaweed extract or a matched placebo daily for an 8 week period, with an 8 week washout period between each treatment. fasting blood and urine samples will be taken from each volunteer at 4 time-points during the study, at baseline and completion of the 2 treatment phases.


Eligibility criteria:
inclusion criteria: * healthy * non-smoker * omnivores and vegetarians * aged 30-65 years * bmi \>25kg/m2 exclusion criteria: * smokers * pregnant/lactating women * vegans * diabetes mellitus, cvd * autoimmune/inflammatory disorders * history of neoplasm * recent acute illness * anti-inflammatory medication * habitual use of vitamin supplements
improving behavioral weight loss via electronic handheld device

Conditions: Obesity

Summary: standard behavioral treatment (sbt) for obesity is often effective, but weight losses are highly variable, and patients sometimes fail to achieve a "successful" weight loss of 5-10% of their starting weight. it has been suggested that the "one size fits all" approach of sbt may be responsible for many treatment failures because the intervention is not sufficiently tailored to address the unique needs of each patient. moreover, treatment is delivered in the clinic, not in the settings and the times when it is needed most. the primary aim of the proposed research is to develop and pilot test a behavioral weight loss intervention that combines in-person sessions with treatment delivered via an electronic handheld device to provide highly individualized weight loss treatment in patients' natural environment. in a critical departure from previous research using cell phone technology, the portion of intervention that is delivered via handheld device will be of equal sophistication and importance to the portion of the intervention that is delivered in face-to-face treatment sessions. the proposed study seeks to determine the feasibility and preliminary efficacy of an individually tailored behavioral weight loss program that integrates clinic-based care and smartphone technology.


Eligibility criteria:
inclusion criteria: * body mass index (kg/m2) of 30-45. * english language fluency * basic familiarity with cell phone technology * ability to read at a 6th grade level * availability to attend weekly treatment sessions in providence, ri exclusion criteria: * any heart condition that limits ability to participate in physical activity * chest pain * any cognitive of physical limitation that would preclude use of a smartphone * serious mental illness * historical or current eating disorder * previous or planned bariatric surgery * use of weight loss medication * recent pregnancy or a plan to become pregnant in the next 6 months * participation in a study at the weight control and diabetes research center within the last two years * a weight loss of greater than 5% body weight in the last 6 months

Keywords: obesity behavior therapy lifestyle technology cellular phone
development and demonstration of intelligent assessment based on multi-modal information fusion for tumor risk and diagnosis and treatment

Conditions: Artificial Intelligence; Deep Learning; Lung Cancer; Lung; Node; Stomach Cancer; Colon Cancer; Cancer Risk; Cancer Screening; Cancer, Treatment-Related

Summary: to improve the accuracy of risk prediction, screening and treatment outcome of cancer, we aim to establish a medical database that includes standardized and structured clinical diagnosis and treatment information, image features, pathological features, and multi-omics information and to develop a multi-modal data fusion-based technology system using artificial intelligence technology based on database.

the main aims are as follows: 1. to establish a data platform for multi-modal information of common tumors (lung cancer/pulmonary nodules, stomach and colorectal cancers) : electronic medical records (including routine clinical detection, treatment, outcome), pathological image data, medical imaging (ct, mri, ultrasound, nuclear medicine, etc.), multiple omics data (genome, transcriptome, and metabolome, proteomics) omics data, etiology and carcinogenic exposure information. 2. we will make use of artificial intelligence technology to create the multi-modal medical big data cross-analysis technology and the above disease individualized accurate diagnosis and curative effect prediction models. in order to solve the three key problems of multi-modal data fusion mining, such as unbalanced, small sample size, and poor interpretability, we will establish an artificial intelligence recognition algorithm for image images and pathological images, and use image processing and deep learning technologies to mine multi-level depth visual features of image data and pathological data. in addition, we will use bioinformatics analysis algorithms to conduct molecular network mining and functional analysis of molecular markers at the level of multiple omics technologies (pathologic, genomic, transcriptome, metabolome, proteome, etc.).

Eligibility criteria:
inclusion criteria: 1. participants with the suspected of lung cancer/node, or stomach cancer/lesion, or colorectal cancer/leision 2. participants that have signed informed consent. 3. participants with detailed electronic medical records, image records, pathological records, multi-omics information, and other important clinical diagnostic information. 4. healthy participants with no clinical diagnosis of lung cancer/node, or stomach cancer/lesion, or colorectal cancer/leision. exclusion criteria: 1. participants with primary clinical and pathological data missing. 2. participants lost to follow-up. 3. participants with too poor medical image quality to perform segment and mark roi accurately
a pragmatic trial of ambulatory toxicity management in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer

Conditions: Early Stage Breast Cancer

Summary: comparison of the number of er plus hospital visits that occurred during chemotherapy between the telephone intervention and control arms.

using a pragmatic cluster-randomized trial design, 20 ontario cancer centres that provide care to patients with breast cancer will be randomly allocated to one of two arms: pro-active telephone toxicity management (intervention), or control (routine care). all patients with early stage (i-iii) breast cancer who commence adjuvant or neo-adjuvant chemotherapy at participating institutions during the 6 to 12-month intervention period (will vary between centres depending on the number of incident cases) will be evaluated using ontario healthcare administrative data. a sub-set of at least 25 patients at each participating institution will participate in a pro sub-study involving the completion of standardized questionnaires to measure: a) severity of chemotherapy treatment toxicities; b) self-care for management of chemotherapy toxicities; c) self-efficacy (confidence) for managing symptoms; d) quality of life; and e) coordination of care. patients participating in the pro sub-study will be asked to provide consent to link their pro data to ontario healthcare administrative data so that correlations between the symptom self-assessments and quality of life (qol) measures can be made with the administrative data on ed+h visits and use of supportive care medications. the investigators will compare the use of supportive care medications (i.e. anti-emetics, growth factors) by patients in the intervention and control arms to assess their influence on severity of chemotherapy-related toxicities as part of an exploratory sub-group analysis in patients \>65 years of age as administrative data on supportive care medication use is only available for this age group.

Eligibility criteria:
inclusion criteria: * women 18 years of age or older * diagnosis of early stage (i-iii) breast cancer * starting adjuvant or neo-adjuvant chemotherapy within the intervention period at a participating centre exclusion criteria: * currently participating in a clinical trial involving an investigational agent inclusion criteria for pro sub-study * willingness to participate in the study and complete pro questionnaires as required * ability to understand and provide written informed consent * language and literacy skills consistent with completing study questionnaires

Keywords: ambulatory toxicity management adjuvant or neoadjuvant chemotherapy
clinical trial to evaluate the efficacy and safety of convalescent plasma for ebola treatment

Conditions: Ebola Virus Disease

Summary: a phase i/ii pilot clinical trial to evaluate the efficacy and safety of ebola virus disease (evd) convalescent plasma (ecp) for treatment of evd.

this pilot trial will treat subjects in the ecp group with ecp derived from two donors. ecp will be provided as ecpsdu each comprising 90 - 110ml of plasma from two individual abo-compatible donors. two ecpsdu will be administered as immediately sequential infusions. subjects may receive up to three doses of ecp not less than 48 hours apart. ecp will be provided as plasma frozen within 24 hours after phlebotomy (pf24) as described in section 6.1. pre-treatment and frequent post-treatment blood specimens for assay of anti-ebov antibody and ebov viral load by rt-pcr will be obtained from subjects. the pharmacodynamic effect of ecp anti-ebov, including neutralization titers, on viral load will be examined in the ecp group. changes of individual and treatment group clinical and laboratory parameters with time will be described. between-group and within-group will examine interactions of clinical parameters, outcome, ecp total dose, ebov viral load, and anti-ebov (igg elisas for zaire gp residues 1-649 and irradiated zaire virus, and anti-ebov prnt). the mews will be assessed as a prognostic tool in the screened control group. efficacy of ecp will be assessed primarily by comparison of survival to hospital discharge between the ecp group and the screened control group.

Eligibility criteria:
inclusion criteria: * adult male or female 18 years of age or older * confirmed case of evd (cdc case definitions 14 sep 2014) * admission to the hospital no more than 48 hours prior to availability of investigational product * able and willing to provide informed consent or family member who is willing and able to provide informed consent if potential subject is unable to consent * venous access adequate for administration of plasma * females only: negative qualitative urine beta-hcg test exclusion criteria: * prior history of severe transfusion reaction * fluid overload or other condition that would contraindicate administration of plasma at the protocol- specified doses * history of blood product transfusion within 30 days prior to enrollment * prior treatment with any other specific experimental anti-evd product or expectation to receive another experimental anti-evd product during the course of the study (does not include general supportive care or nutritional supplements routinely administered to all hospitalized patients with evd) * unresponsive on avpu (alert, voice responsive, pain responsive, unresponsive) testing
multi-national, safety and performance study of new ostomy product compared to standard care

Conditions: Leakage; Skin Condition

Summary: the primary object of this study is to provide clinical documentation for the new base plate significantly 'reduces the degree of leakage' under the base plate compared to standard care base plates. the secondary objectives are to provide clinical documentation on several performance and safety parameters on the new base plate compared to standard care base plates. the primary hypothesis is that the new base plate significantly reduces degree of leakage under the base plate compared to standard care base plates. each test period will last for two weeks. in addition to this there will be one week run-in period on new base plate. the data will be collected by investigator in the case report form at the inclusion visit, cross-over visit and termination visit. data will also be collected by the subject in a questionnaire during the two test periods. the subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period. 100 subjects with ileostomy will be included in the study. the subjects will be recruited from europe including denmark, norway, sweden, iceland, germany and france.


Eligibility criteria:
inclusion criteria: 1. have given written informed consent 2. is at least 18 years old 3. has the mental capacity to understand the study guidelines and questionnaires 4. has had their ileostomy for at least 3 months 5. has an ileostomy with a diameter between 19-40 mm 6. is currently using a flat 2-piece product with with mechanical coupling 7. is able to change the base plate by themselves or with help from a caregiver (e.g. spouse) 8. has experienced leakage under the base plate at least once a week over the last 2 weeks exclusion criteria: 1. is pregnant or breast-feeding 2. currently receiving or has within the past 2 months received radio- and/or chemotherapy 3. currently using topical steroid product on peristomal skin (injections and oral treatment are accepted) 4. is currently using a convex base plate 5. participating in other clinical studies or has previously participated in this study
trial to evaluate the short-term safety & efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia

Conditions: Schizophrenia

Summary: to determine the safety \& efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.

this is a multicenter, randomized, double-blind, placebo- and active-controlled trial to evaluate the safety and efficacy of brexpiprazole monotherapy compared to placebo in adolescent subjects (ages 13-17) with a dsm-5 diagnosis of schizophrenia.

Eligibility criteria:
inclusion criteria: * male \& female subjects aged 13-17 years, inclusive at time of consent and at baseline visit, with a primary diagnosis of schizophrenia as defined by dsm-5 criteria and confirmed by k-sads-pl and a history of the illness for at least 6 months prior to screening. * panss score \>= 80, inclusive, at screening and baseline exclusion criteria: * subjects with a dsm-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening. * subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia or other cognitive disorders * subjects who have been hospitalized \> 21 days for a current exacerbation of schizophrenia at the time of baseline. * any neurological disorder other than tourette's syndrome * subjects at significant risk of committing violent acts, serious self-harm or suicide based on history * subjects with epilepsy, a history of seizures, severe head trauma or stroke * subjects who test positive for drugs of abuse at screening

Keywords: brexpiprazole schizophrenia adolescent
oral cancer with wide excision and free flap reconstruction

Conditions: Head and Neck Cancer

Summary: a proactive speech-language pathologist program can be successfully established as part of the multidisciplinary care of patients with head and neck squamous cell carcinoma and improve patient quality of life.

head and neck cancer treatment has developed over the last decade, with improved mortality and survival rates, but the treatments often result in dysphagia (a difficulty in swallowing) as a side effect. swallowing function is affected by the tumor itself, surgical resection of the lesion and neoadjuvant chemoradiation therapy. it is well accepted that pre-treatment swallow function is indicative of post-treatment status and is helpful in identifying patients with high risk of aspiration and dysphagia. in recent years, the concept of "use it, or lose it" has been widely advocated by specialists. preventive swallowing rehabilitation including evaluation patient's swallowing function and propose rehabilitation and adaptive maneuver or change in food texture. the aim is to ensure safe swallowing and prevent deglutitive muscles from deconditioning. moreover, aspiration can be prevented and adequate nutrition was maintained through the cancer treatment course. investigators include patients with advanced oral cavity cancer who were treated by radical operation and free flap reconstruction, and provided them with preventive swallowing rehabilitation. investigators then analyze the swallowing function, oral intake status, and nasogastric tube dependence rate and tracheostomy tube dependence rate.the participants received interventions as part of our routine medical care, and investigators studied the effect of the intervention.

Eligibility criteria:
inclusion criteria: advanced oral cancer patients treated with wide excision and free flap reconstruction exclusion criteria: not willing to participate
software-aided imaging (morfeus) for confirming tumor coverage with ablation in patients with liver tumors, the cover-all study

Conditions: Malignant Liver Neoplasm

Summary: this phase ii trial studies how well software-aided imaging works in confirming tumor coverage with ablation (the removal or destruction of a body part or tissue or its function) on patients with liver tumors. the current standard for targeting tumor cells and evaluating the outcome of a liver ablation procedure is a visual inspection of the pre- and post-procedure computed tomography (ct) scans. software-aided imaging systems, such as morfeus, may help to improve the accuracy and effectiveness of liver ablation.

primary objective: i. to evaluate if the intra-procedure feedback of a biomechanical deformable registration volumetric image method during percutaneous ablation will increase the minimal ablation margins on a three-dimensional computed tomography-generated analysis. secondary objectives: i. to assess whether applying the proposed method during percutaneous ablation improves local tumor progression-free survival (ltpfs) rates. ii. evaluate impact of software use on procedure workflow. iii. impact of software use on complication rates, quality of life, liver function. iv. evaluate oncological outcomes (intra-hepatic and overall progression-free survivals, and overall survival). outline: patients are randomized to 1 of 2 arms. arm i: patients undergo standard of care ablation. arm ii: patients undergo standard of care ablation with software-aided imaging (morfeus). after completion of study, patients are followed up at 1, 3, and 6 months, and then at 1 and 2 years.

Eligibility criteria:
inclusion criteria: 1. patients presenting with ≤ 3 liver tumors (biopsy-proven or documented by imaging) measuring 1 to 5 cm planned to undergo percutaneous thermal ablation with either microwave or radiofrequency ablation. patients with more than 3 tumors might also be eligible in case other tumors can be treated with another curative-intended loco-regional therapy (i.e. surgical resection, radiation therapy). 2. ability to completely cover the target tumor with at least a 5 mm ablation margin. 3. written informed consent to voluntarily participate in the study and follow-up ct scan schedule 4. age \> 18 years-old 5. performance status 0-2 (eastern cooperative oncology group classification \[ecog\]) 6. target tumor should be visualized on contrast-enhanced ct 7. adequate glomerular filtration rate exclusion criteria 1. active bacterial infection or fungal infection on the day of the ablation that, in the opinion of the investigator, would interfere with safe delivery of the study procedure or with the interpretation of study results. 2. platelet \< 50,000/mm3. 3. inr \> 1.5 4. patients with uncorrectable coagulopathy. 5. currently breastfeeding or pregnant (latter confirmed by serum pregnancy test). 6. physical or psychological condition which would impair study participation. 7. asa (american society of anesthesiologists) score of \> 4. 8. any other loco-regional therapies at the target lesion(s) within 30 days of the ablation procedure.
lung cancer screening using dna methylation changes in circulated tumor and pbmc dna

Conditions: Lung Cancer; Lung Cancer, Nonsmall Cell; Lung Cancer, Small Cell

Summary: a central challenge in the fight against lung cancers is how to detect disease in a noninvasive manner before it is detectable by imaging methods. although inroads have been made with more sensitive imaging techniques for earlier detection of breast and lung cancers, these techniques are limited by the size of lesion that could be detected. alternatively, several blood proteomic biomarkers have been proposed but none offer as of yet sufficient predictive power. consequently, effective non-invasive tools as prognostic indicators and biomarkers of lung cancer is urgently needed. the purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in pbmc and circulated tumor dna in lung cancer patients.


Eligibility criteria:
inclusion criteria: * histological confirmed lung cancer exclusion criteria: * pregnant women * minors (subjects less than 18 years of age) * prisoners * patients with known infectious disease, such as human immunodeficiency virus (hiv), tuberculosis (tb), or hepatitis b, c * patients having other than one cancer * subjects unable to consent for themselves