Kornimate/medical-research-clean huggingface dataset:
apricot-p: study of apricoxib with gemcitabine and erlotinib to treat advanced pancreatic cancer

Conditions: Pancreatic Cancer; Metastatic Pancreatic Cancer

Summary: this study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.

this study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down regulation of cox-2 and egfr pathways in patients with up-regulated cox-2 expression in tumors will have a clinical benefit compared with gemcitabine/erlotinib only.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic. 2. life expectancy greater than or equal to 3 months. 3. patients must have measurable disease by recist. 4. ecog ps of 0, 1, or 2. 5. negative serum pregnancy test at the time of first dose for women of childbearing potential. exclusion criteria: 1. previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 t3 and t4, and all stage 4). 2. rt within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment. 3. evidence of new york heart association class iii or greater cardiac disease. 4. history of myocardial infarction, stroke, ventricular arrhythmia. 5. symptomatic central nervous system metastases. 6. pregnant or nursing women. 7. hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (nsaids). 8. history of upper gastrointestinal bleeding, ulceration or perforation. history of lower gi bleeding, ulceration, or perforation within 12 months. 9. previous anti-egfr kinase therapy.
a pilot study to evaluate the systemic inflammatory response of thoracoabdominal aortic aneurysm repair.

Conditions: Aortic Aneurysm, Thoracic; Systemic Inflammatory Response Syndrome

Summary: the purpose of this study is to look at the systemic inflammatory response caused when patients undergo thoracoabdominal aortic aneurysm repair (taaa). in addition, this study will look at how the inflammatory response affects the post operative healing process and post operative complications.

patients will be invited to participate in this study prior to the taaa repair procedure. prior to the surgery, baseline blood and saliva samples will be collected. following the surgery, blood and saliva samples will be collected for 48 hours. in addition, hemodynamic data (i.e. vital signs) will be collected for the first 48 hours. the patient data will be reviewed for the first 30 days for morbidity and mortality assessment.

Eligibility criteria:
inclusion criteria: * elective taaa repair exclusion criteria:

Keywords: elective taaa repair
effects of routines-based early intervention in children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder (asd) mainly has social and interaction related problems, and repetitive behaviors or interests. in recent years, studies showed that routine-based early intervention(rbei) could increase children's development and enhance skills maintenance. using the international classification of functioning, disability and health for children and youth (icf-cy) to assess children can identify different factors under systematic analysis, then improving children's physical functions and self-care abilities. therefore, this study will design rbei programs for autistic children, and use icf-cy to assess the efficacy of rbeiin body function, body structure, and participation for children with autism.

study will enroll 30-40 children with asd, aged 3-9 years. children will receive subjective and objective assessment for pre-test, post-test and three-monthfollow-up after treatment. after pre-test, children will be randomized and assigned to either the experimental group or the control group. the experimental group willreceive rbei and the control group willreceive traditional therapy. the treatment period is 12 weeks, 1-2 times a week, 1-2hours each time, and homework is given during the treatment period, allowing parents to do treatment at home. post-test will be conducted immediately after the end of treatment period, and homework will continue until three-month follow-up conducts. it is expected that after intervention, the physical function, activities and participation, quality of life of the experimental group will improve and significantly different from the control group.

Eligibility criteria:
inclusion criteria: * parents are willing to sign written consent form * diagnosed as asd by doctor * no neurological disease exclusion criteria: * active medical condition * progressive or degenerative symptoms or illness

Keywords: autism spectrum disorder routine-based early intervention
hdl dysfunction during the acute stage of stroke

Conditions: Stroke, Acute

Summary: the study investigates the effect of plasma myeloperoxidase (mpo) concentrations on hdl dysfunction during the acute stage of ischemic and haemorrhagic strokes.

mri or ct scan are used to confirm the diagnosis of haemorrhagic, ischemic and mimick stroke. plasma anf hdl-mpo concentrations, as well as potent hdl dysfunction, are compared in the 3 cases. the investigators hypothesis is that mpo concentrations and subsequent hdl dysfunction could be higher in ischemic strokes than in haemorrhagic ones. mpo could be a examined as a potent marker of early stage of ischemic stroke. plasma mpo levels could also be discriminant regarding the mimick strokes in patient exhibiting stroke clinical picture.

Eligibility criteria:
inclusion criteria: patients with less than 12 hours stroke clinical signs: * hemiparesis or hemiplegia * unilateral sensitivity disorder * language impairment * balance disorder * dizziness, bilateral or monocular vision totally or partially lost exclusion criteria: * pregnancy * head trauma since the last 3 months * stroke since the last 3 months * myocardial infarction since the last 3 months * patient disagrees to be enrolled in the study
assessment of safety, pharmacokinetics and efficacy in a combination treatment with smp-114

Conditions: Rheumatoid Arthritis (RA)

Summary: to compare the efficacy of smp-114 (120 and 240 mg/d) versus placebo in terms of the percentage of patients meeting the american college of rheumatology criteria for 20% improvement in ra (acr20) at week 24. the study hypothesis would be to demonstrate that the use of methotrexate and smp-114 is more efficacious than methotrexate alone.


Eligibility criteria:
inclusion criteria: * male or female patients aged at least 18 years, with ra for a minimum of 6 months * has been receiving methotrexate treatment (stable for 8 weeks) * has active disease classified as acr functional class of i, ii or iii exclusion criteria: * has previously discontinued dmard therapy due to hepatic intolerance * has received any dmard in addition to methotrexate during the 4 weeks prior to randomisation * is receiving more than 2 dmards in addition to methotrexate at the time of screening * is receiving or has received gold, leflunomide or biological agents including tnf/il-1 inhibitors within the 8 weeks prior to randomisation * has previously failed 2 or more dmards
left main coronary artery stenosis and angioplasty with taxus stent

Conditions: Coronary Arteriosclerosis

Summary: the purpose of this study is to determine whether percutaneous coronary angioplasty with taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not.

coronary artery bypass graft is the reference treatment of left main coronary artery disease. with the advancements of technology and particularly drug-eluting stents, in-stent restenosis has dramatically decreased and now it is possible to extend indications of complexes lesions such as left main coronary artery stenoses. in these particular situations,some centers performed percutaneous coronary angioplasty (pci) with drug-eluting stents with acceptable results in terms of safety and efficacy. however, these procedures are performed at isolated sites and are not evaluated in multicenter trial.the aim of this study is to assess the safety and efficacy of this pci with taxus-stent in a french multicenter trial and to evaluate clinical and angiographic outcome of these patients at long-term follow-up.

Eligibility criteria:
inclusion criteria: * the patient must be \> or = 18 years of age * patient must provide written informed consent prior to the procedure using a form that is approved by the local ethics committee * aspirin + clopidogrel \> or = 12 hours before percutaneous coronary intervention (pci) * documented evidence of ischemic heart disease (clinical,biological or ecg) with unprotected left main coronary artery stenosis \> or = 50% associated to other coronary lesions or not responsible of stable or unstable coronary syndrome above 48 hours * the target reference vessel diameter must be \> or = 2.5 mm * unprotected left main coronary artery disease eligible by coronary stenting exclusion criteria: * restenosis lesion in left main coronary artery * known allergies to the following: aspirin, clopidogrel,ticlopidine,contrast agent or drug similar to paclitaxel * acute coronary syndrome \< 48 hours * impaired renal function (creatinine \> 180 ùmol/l) at the time of treatment * life expectancy less than 36 months * female of childbearing potential without reliable birth control * currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints

Keywords: left main coronary artery stenosis, stent, taxus unprotected left main coronary artery disease percutaneous coronary intervention with taxus stent
evaluation of usage and efficacy of the 656 online platform for reducing caregiver stress in chinese caregivers

Conditions: Stoke; Dementia; Fall and Fractures Prevention

Summary: this study aimed to assess the efficacy of a new online platform, 656 online platform, in hong kong in reducing caregiver stress and enhancing caregiver preparedness and competence of caring for older adults with stroke, dementia, and fracture, investigate the factors influencing the usage of the online platform, and examine user satisfaction and engagement.

the informal caregivers of older adults with serious health problems, especially for stroke, dementia, and fracture, are facing numerous caregiving stress. the online platform can be a cost-effective way to support caregivers and reduce their caregiving stress. a new online platform, the 655 online platform, was developed by st. james settlement in hong kong, to provide caregivers with appropriate information and support, attempting to reduce their pressure. therefore, this study was launched to evaluate the efficacy of a new online platform in reducing caregiver stress and enhancing caregiver preparedness and competence in caring for older adults with stroke, dementia, and fracture, investigate the factors influencing the usage of the online platform, and examine user satisfaction and engagement. a longitudinal open-trial study design was applied (n=287) with outcome measures administered at baseline, 3-month follow-up, and 15-month follow-up. primary outcomes included changes in caregiver stress, caregiver preparedness, and competence. the user profile was explored by comparing the characteristics of participants in user group and non-user group. user satisfaction and engagement were also reported.

Eligibility criteria:
inclusion criteria: * family caregivers who are chinese citizens aged 18 or above and provide care for elderly individuals aged 65 or above diagnosed with stroke, dementia, or fall-related fractures exclusion criteria: * family caregivers who have been diagnosed with severe mental or physical illness or have impairments in cognitive function, such as comprehension, memory, observation, and other related abilities

Keywords: online platform caregivers caregiver stress
study of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer

Conditions: Local Advanced Non-small Cell Lung Cancer

Summary: this single-arm phase ii prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer.

this single-arm phase ii prospective study is to determine the efficacy of early nutritional intervention during concurrent chemoradiotherapy for local advanced non-small cell lung cancer. patients in the study group received early nutritional intervention, including individualized nutrition counseling and oral nutritional supplements from the initiation of ccrt to 2 weeks after its completion. weekly counseling sessions, conducted by both doctors and nurses, aimed to educate patients on regulating their regular dietary intake to meet specific energy, protein, and other macronutrient requirements. dietary advice provided precise instructions on food type and quantity, meal frequency, and calorie or protein intake to ensure a daily energy intake of approximately 30 kcal/kg. all patients received definitive thoracic radiotherapy with total radiation doses of 60-68 gy, concurrent with weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡).

Eligibility criteria:
inclusion criteria: * confirmed unresectable stage iiia-iiic non-small cell lung cancer. * recieved definitive concurrent chemoradiotherapy. * pretreatment pg-sga score a or b. * eastern cooperative oncology group (ecog) performance status 0-1. * estimated life expectancy of at least 6 months. * without contraindication for chemoradiotherapy. exclusion criteria: * severe impairment of intestinal function, or intolerance of enteral nutrition. * severe vomiting, gastrointestinal bleeding, or intestinal obstruction. * severe malnutrition, or intolerance of chemoradiotherapy.

Keywords: local advanced non-small cell lung cancer chemoradiotherapy early nutritional intervention
quantitative ultrasound for the evaluation of simple bone cyst healing

Conditions: Simple Bone Cyst

Summary: simple bone cysts (sbcs), also known as unicameral bone cysts (ubcs), are benign bone lesions. literature to date describes little agreement between clinicians on specific prognostic criteria for the prediction of cyst healing, recurrence or fracture. evidence has shown that bone mineral density (bmd) is a reliable indicator of risk to sbc patients given its association with the mechanical properties of bone. there has been further exploration into the use of quantitative ultrasound to assess bone density by measuring the velocity of the ultrasound transmission over the bone. to determine whether the qus can provide prognostic information with respect to cyst healing, recurrence or fracture with a sbc, further study is needed.


Eligibility criteria:
arm 1 - simple bone cyst patients inclusion criteria 1. patients ≥ 2 and ≤ 21 years 2. patients with a diagnosis of simple bone cyst located in a long bone confirmed by imaging within 3 months prior to registration 3. all patients and/or their parents or legally authorized representatives must sign a written informed consent. assent, when appropriate, will be obtained according to institutional guidelines. exclusion criteria 1. patients with implants to stabilize the bone where the cyst is located. 2. patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, paget's disease) 3. patients who are pregnant or breastfeeding 4. patients with a simple bone cyst crossing the growth plate arm 2 - healthy controls inclusion criteria 1. patients ≥ 2 and ≤ 21 years 2. all patients and/or their parents or legally authorized representatives must sign a written informed consent. assent, when appropriate, will be obtained according to institutional guidelines. exclusion criteria 1. patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, paget's disease) 2. patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.) 3. patients who are pregnant or breastfeeding arm 3 - fracture patients inclusion criteria 1. patients ≥ 2 and ≤ 21 years 2. patients who have undergone any type of casting or surgical treatment for their fracture 3. all patients and/or their parents or legally authorized representatives must sign a written informed consent. assent, when appropriate, will be obtained according to institutional guidelines. exclusion criteria 1. patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, paget's disease) 2. patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.) 3. patients who are pregnant or breastfeeding
effective conversion of individuals at risk

Conditions: Obstructive Sleep Apnea; Atrial Fibrillation

Summary: this study aims to guide participants in recognizing their osa (obstructive sleep apnea) and afib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis

the primary objective is to analyze how many patients at risk of medical conditions will be converted to a health care professional by a smartphone application. historical data (number of patients at risk of osa and/or afib that seeked help for their condition in the past year) from institute will be used as a reference. we will refer to this as the 'baseline conversion rate', reflecting the natural transition of patients in the general healthcare system.

Eligibility criteria:
inclusion criteria: * high risk of osa and/or afib, as defined by the risk algorithm developed by sanford health * 18 years or older, with sufficient english language skills * owning a smartphone with a relatively new operating system (ios v. 14 (iphone 6s or higher) or an android device v.11\<) * able to download and handle an app on a smartphone * willing and able to give informed consent exclusion criteria: * diagnosed with osa and/or afib * diagnosed health issues that are potentially life threatening or causing mental issues (stroke, alzheimer's disease, depression, etc.) * pregnancy/breast feeding

Keywords: osa afib
vitaflow® transcatheter aortic valve replacement system pre-market trial long term follow up （vital）

Conditions: Aortic Valve Disease; Aortic Valve Stenosis

Summary: this study is an observational study to evaluate the long-term safety and effectiveness of the valve system.

this study is an observational study, for who have joined the vitaflow® catheter aortic valve system pre-market trial (protocol no. valve -2014-04) in 4 designated research institutions, and follow-up from 6 to 10 years after the procedure, to evaluate the long-term safety and effectiveness of the valve system.

Eligibility criteria:
inclusion criteria: * must meet 1, 2, 3, 4 or 1, 5 to be selected: 1. patients who have participated in the vitaflow® transcatheter aortic valve system pre-market trial in the 4 designated research institutions\*; 2. be able to get in touch with the patient or his legal guardian/relative; 3. patients who can understand the purpose and nature of the follow-up of this study, and are willing to cooperate with the follow-up and provide follow-up information; 4. sign the informed consent form; 5. patients who are known to have died. * 4 research institutions: zhongshan hospital fudan university, second affiliated hospital of zhejiang university school of medicine, west china hospital of sichuan university and fuwai hospital. exclusion criteria: 1. participate in clinical trials of other drugs or medical devices and have not yet reached the primary endpoint; 2. the investigator judges that the patient's compliance is poor and the study cannot be completed as required.
a cross sectional study evaluating the mean levels of alpha fetoprotein in patients of hepatocellular carcinoma and its correlates in pakistan

Conditions: Carcinoma, Hepatocellular

Summary: this study aims to explore the levels of alpha-fetoprotein (afp), a protein often elevated in liver cancer, in patients with hepatocellular carcinoma (hcc). the goal is to determine whether afp levels vary based on the size of the liver tumor or other health conditions like hepatitis b, hepatitis c, and obesity. by analyzing data from 94 patients, the study seeks to identify factors that influence afp levels, which may help in understanding liver cancer progression and improving diagnosis and treatment approaches.


Eligibility criteria:
inclusion criteria: * aged between 27 to 80 years. * diagnosed with hepatocellular carcinoma (hcc) within the last three months. * diagnosis confirmed by relevant investigations (e.g., imaging, liver biopsy). * able to provide informed consent. exclusion criteria: * elevated alpha-fetoprotein levels due to tumors other than hcc. * presence of secondary liver metastases from other primary sites. * any significant comorbid conditions that could interfere with study assessments. * pregnancy or breastfeeding.

Keywords: hepatocellular carcinoma (hcc) alpha-fetoprotein (afp) levels liver cancer biomarkers tumor size and afp correlation hepatitis b and c in liver cancer non-alcoholic steatohepatitis (nash) afp as a diagnostic tool liver tumor progression markers