Kornimate/medical-research-clean huggingface dataset:
anthocyanin intake on cardiometabolic biomarkers

Conditions: Coronary Artery Stenosis

Summary: flavonoids are one of the main groups of polyphenols. anthocyanins, which are a subgroup of the flavonoid family, are found in a number of fruits and some vegetables. in epidemiological studies, high dietary intake of polyphenols has been associated with improvement of some cardiometabolic risk factors in high-risk individuals. furthermore, in controlled studies, consumption of polyphenol-rich food sources or anthocyanin extract supplementation has improved some cardiometabolic factors. in the present study, the effect of diet enriched with anthocyanin-rich food sources on cardiometabolic factors will be studied in coronary artery disease patients.

this study is an unblinded randomized controlled clinical trial. in this study, among the patients referred to shahid modares hospital (tehran, iran), those who are willing to participate and have inclusion criteria will be recruited. inclusion criteria are coronary heart disease with recent coronary angiography, age range of 30-75 years. exclusion criteria are end-stage renal disease, patients undergoing chemotherapy or radiotherapy, patients with inflammatory bowel syndrome, patients being treated with glucocorticoid drugs or antibiotics. patients are randomly assigned to one of two study groups, including the control group and the group consuming food sources rich in anthocyanin in the diet. the duration of the study will be 8 weeks. in the control group, a general recommendation related to a healthy diet such as reducing the intake of saturated fats, sodium, and simple sugars, is provided. in the anthocyanin-rich diet group, the weekly food plan aims to increase the consumption of anthocyanin-rich sources such as berries, black grapes (or currants), cherries, strawberries, pomegranates, and red onions. the patients' drug regimen will not change during the study. patients are asked not to use over-the-counter herbal medicines and nutritional supplements during the study. at the beginning and end of the study, blood,

Eligibility criteria:
inclusion criteria: * coronary heart disease with recent coronary angiography exclusion criteria: * end-stage renal disease, * patients undergoing chemotherapy or radiotherapy, * patients with inflammatory bowel syndrome * patients being treated with glucocorticoid drugs or antibiotics.
web-based and tailored asthma management intervention (puff city) in teens with asthma attending urban clinics

Conditions: Asthma

Summary: the purpose of this study is to evaluate the puff city web-based behavioral intervention of asthma management program in a clinical setting. this study also examines and evaluates the cost and efficiency of patient eligibility determination methods, patient recruitment, study monitoring (compliance with study regimen, participant retention and follow-up), and the collection of clinical endpoints.

asthma continues to be a major public health problem in the us with high economic and social costs. vulnerable ethnic communities are disproportionately affected by asthma as demonstrated by higher morbidity and mortality for these groups. we have completed two school-based, randomized trials of a web-based, computer-tailored asthma management intervention that targets urban teens (puff city). the current study, puff city in the clinic, will be evaluated as a clinical tool by initiating the web-based behavioral intervention of asthma management in a clinical setting. however, the current paradigm for conducting such a trial is costly with respect to patient recruitment, intervention delivery, and data collection and management. to address these high costs, the study utilizes comparative effectiveness research (cer) pragmatic approaches to design a randomized controlled trial for patient recruitment and determination of eligibility, study monitoring (compliance with study regimen, participant retention and follow-up), and collection of clinical endpoints.

Eligibility criteria:
inclusion criteria: * 13-19 years of age * must be able to provide electronic assent and have consent from a parent/guardian if applicable * diagnosis of asthma by meeting one of the following criteria within the last 12 months: * at least one emergency department diagnosis of asthma or * at least one acute inpatient encounter with asthma as the principal diagnosis or * at least four outpatient visits with an asthma diagnosis and at least 2 asthma medications dispensed or * at least four asthma medications dispensed exclusion criteria: * inability to provide informed consent/assent * lack of physician diagnosis of asthma * other co-morbidities that make it impossible for the individual to participate.

Keywords: urban adolescents acute asthma asthma computer tailoring web-based intervention puff city
a study of siriraj home exercises protocol for primary osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to compare the exercise protocol called "siriraj home base exercise program for oa knee" to usual care and physical modalities for conservative treatment in patients with 1st oa knee.


Eligibility criteria:
inclusion criteria: * 1st osteoarthritis of the knee age \>/= 50 yrs exclusion criteria: * previous knee surgery for oa knee treatment * has plan or schedule for knee surgery * severe degree of oa knee.

Keywords: home base exercise
diet therapy versus prescriptive educational group intervention in overweight / obese patients at first episode of ami: a randomized controlled trial

Conditions: Obesity /Overweight; Acute Myocardial Infarction (STEMI/ NSTEMI)

Summary: results after interventions on lifestyle in the secondary prevention of ischemic heart disease are not always consistent, and the guidelines multidisciplinary measures aren't easily achievable. therefore, the purpose of this research project is the identification of an interventional approach to effective secondary prevention and realistic feasibility, in a field of multifactorial risk. the study is open to patients who totaled a double chronic disease, obesity/overweight and coronary heart disease, and who experienced a first event of ischemic cardiac infarction (ami). the aim is to evaluate the effectiveness of a group educational intervention in a sample of overweight and obese patients (bmi \> 24.9) incurred in a first episode of acute myocardial infarction (non-stemi and stemi), comparing with the classic approach of prescriptive diet therapy.


Eligibility criteria:
inclusion criteria: subjects of both sexes and age ≥ of 18 years consecutively admitted to the coronary unit of irccs foundation policlinico s. matteo, at first episode of stemi or non-stemi ami, with bmi greater than 24.9. exclusion criteria: patients who can not provide informed consent (because illiterate or with significant language barrier or severe deficit/cognitive decays). subjects with diseases and/or disabling organ damage. subjects affected by active neoplasm. individuals who have submitted arhythmic complications in acute and/or heart failure, or people referring to post-ami residential rehabilitation. subjects that are carriers of severe psychiatric disorders diagnosed by dsm-v -tr.
a study assessing risk factors for oral mucositis/stomatitis and ocular surface events in nsclc and breast cancer

Conditions: Advanced/Metastatic NSCLC; Advanced/Metastatic HER2-negative Breast Cancer

Summary: this study will identify risk factors for oral mucositis/stomatitis and ocular surface events (ose) in patients with advanced/metastatic non-small cell lung cancer (nsclc) and advanced/metastatic human epidermal growth factor receptor 2 (her2)-negative breast cancer.

it is important to identify risk factors for the onset of oral mucositis/stomatitis and ose to identify high-risk patients who will be taking dato-dxd. understanding these risk factors in patients receiving standard-of-care anti-cancer therapies may also help with mitigation strategies. this objective will be achieved by identifying and describing patient demographics and clinical characteristics of cases with oral mucositis/stomatitis and ose. no study drug will be provided or administered for this study.

Eligibility criteria:
inclusion criteria 1. the inclusion criteria for the nsclc cohort consists of patients with advanced or metastatic (stage iiib/iiic or iv) nsclc diagnosis between january 1, 2015 and december 31, 2023 who are at least 18 years old at the time of first diagnosis (cohort entry date) and treated with at least one line of therapy (lot) for advanced/metastatic disease. 2. the inclusion criteria for the breast cancer cohort consists of female patients with advanced or metastatic (stage iiib/iiic and iv) her2-negative bc diagnosis between january 1, 2012 and december 31, 2023 who are at least 18 years old at the time of first diagnosis (cohort entry date) and treated with at least one lot for advanced/metastatic disease. exclusion criteria 1) the exclusion criteria for both cohorts consist of patients with other primary cancer type prior to the cohort entry date and patients who are pregnant 9 months (275 days) prior to, on, or after the cohort entry date.

Keywords: advanced/metastatic non-small cell lung cancer (nsclc) advanced/metastatic human epidermal growth factor receptor 2 (her2)-negative breast cancer oral mucositis/stomatitis ocular surface events
a study of c-car088 in patients with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a multicenter, open-label study to evaluate the safety and efficacy of c-car088 in patients with relapsed or refractory multiple myeloma. the phase ib part of this study is to determine the recommended phase 2 dose (rp2d) of c-car088 in the targeted patient population.

the study includes the following sequential procedures: screening, apheresis and c-car088 manufacturing, baseline testing, lymphodepletion, c-car088 infusion, and follow-up visit. two dose levels of c-car088 will be tested during the phase ib part to determine rp2d, which will be further evaluated during the phase ii part.

Eligibility criteria:
inclusion criteria * ≥ 18 years of age, male or female patients * relapsed or refractory multiple myeloma * have been treated with ≥ 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug, and had progressed during or within 12 months post the last treatment. * had measurable disease as defined by any of the following criteria: * serum m protein ≥ 0.5g/dl * urine m protein ≥ 200mg/24h * serum free light chain (sflc): abnormal κ/λ ratio with involved sflc ≥ 100mg/l * adequate liver, renal, bone marrow, and heart function * eastern cooperative oncology group (ecog) 0-1 exclusion criteria * any known allergies to the components or excipients of the c-car088 cell product * prior allogeneic hematopoietic stem cell transplantation (hsct) at anytime, or autologous stem-cell transplantation (asct) within 12 weeks prior to apheresis * central nervous system (cns) involvement * stroke or convulsion history within 6 months prior to signing informed consent form (icf) * plasma leukemia * autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment * uncontrolled active infection; active hepatitis b virus (hbv), hepatitis c virus (hcv) infection; hiv or syphilis infection * severe heart, liver, renal or metabolism disease * inadequate wash-out time for previous anti-tumor treatments prior to apheresis * previous car-t cell treatment, genetically modified t-cell therapies or bcma-directed treatment history * history or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial
descripitive patient analysis to enable risk-based quality improvement measures in a large internal medicine group practice

Conditions: Liver Dysfunction; Thyroid; Atherosclerosis; Heart Failure; Intestinal Disease; Heart Diseases

Summary: background: clinical trials often include patients from large hospitals or university clinics. information on patients cared for at offices from statutory health insurance-accredited physicians represent evidence gaps. aims/objectives: the present study has three aims: first, to systematically describe the patient population of a large group practice for internal medicine. second, to identify high-risk patients using established risk scores. and third, to include routine imaging data to optimize patient management. methods/facility enrolling participants: this is a prospective, observational study assessing patients' baseline characteristics, risk evaluation and integrating data from imaging test. the setting of the present study is a large group practice for internal medicine which consists of statutory health insurance-accredited physicians. study participants will be included during daily routine, real-world clinical care and therefore represent all-comers fulfilling the inclusion criteria: 1. female or male patients aged above 18 years diagnosed with chronic liver disease, undergo on-site endoscopy, suffer from atherosclerosis, heart failure, are diagnosed with abnormal serum thyroid-stimulating hormone (tsh) levels, either overt or latent hypo- or hyperthyroidism, or are diagnosed with solitary or multiple thyroid nodules. 2. routine laboratory results available within the last 3 months. 3. available imaging data within the last 3 months performed on site. perspective: the study is designed to evaluate the current situation and quality of health care in defined patient populations in the routine clinical setting of a large-scale public office. these data will provide a profound rationale to identify quality issues and limitations in our performance of guideline-conform treatment in routine patient care.


Eligibility criteria:
1. female or male patients aged above 18 years diagnosed with chronic liver disease, undergo on-site endoscopy, suffer from atherosclerosis, heart failure, are diagnosed with abnormal serum thyroid-stimulating hormone (tsh) levels, either overt or latent hypo- or hyperthyroidism, or are diagnosed with solitary or multiple thyroid nodules. 2. routine laboratory results available within the last 3 months. 3. available imaging data within the last 3 months performed on site.
sufentanil used by paramedics to treat pain in acute trauma

Conditions: Trauma Injury; Pain

Summary: the new competence of paramedics to administer opioid analgesics in acute trauma patients without presence or phone-call consult with an emergency medical doctor will be assessed in this study.

the administration and indication of an opioid analgesics is carried by a medical doctor in most european emergency services. however, trips to majority of less serious traumas are realized by ambulances with paramedic crews without a medical doctor present on site. in this study will be assessed the new competence of paramedics to administer opioid analgesics without presence or phone-call consult with an emergency medical doctor. this study will address the safety and efficacy of sufentanil administered by the paramedics in the field to patients with acute trauma without any consultation with medical doctors.

Eligibility criteria:
inclusion criteria: * acute trauma with severe pain (vas/nrs \> 4) * age \> 18 years * conscious patient (gcs = 15; alert in avpu) * haemodynamically stable patient (\> 100mmhg of systolic blood pressure, \> 60/min of heart rate) exclusion criteria: * doctor on site * paediatric patient * predominantly chronic but not acute pain * incomplete documentation * other than traumatic reasons for opioid administration (eg. acute coronary syndrome)

Keywords: sufentanil paramedic acute trauma injury prehospital emergency care
evaluation of the performance of air optix® colors

Conditions: Myopia

Summary: the purpose of this study was to assess the ocular response to and performance of the cosmetically printed silicone hydrogel contact lens air optix® colors compared to freshlook® colorblends.

the study was conducted in two phases. phase 1 was an adaptation phase where participants wore air optix® aqua contact lenses bilaterally (same product in both eyes) on a daily wear basis for 1 week. in phase 2, participants wore air optix® colors and freshlook® colorblends contact lenses contralaterally (different product in each eye) on a daily wear basis for 4 weeks.

Eligibility criteria:
inclusion criteria: * full legal capacity to volunteer; * read and sign information and consent letter; * willing and able to follow instructions and maintain the appointment schedule; * ocular examination in the last two years; * currently wears soft contact lenses on a daily wear basis; * contact lens prescription between -1.50 diopters and -5.00 diopters; * other protocol-defined inclusion criteria may apply. exclusion criteria: * any ocular disease; * any systemic condition that may affect a study outcome variable; * any systemic or topical medications that may affect ocular health; * known sensitivity to the diagnostic pharmaceuticals used in the study; * unable to achieve an acceptable fit with the study lenses; * anisometropia \>1.00 diopter or astigmatism \>0.75 diopter; * use of lubricating/rewetting eye drops. * other protocol-defined exclusion criteria may apply.
high protein breakfast on postprandial glycemia in t2d (pbd)

Conditions: Type 2 Diabetes

Summary: the investigators hypothesis is that eating whey protein in breakfast will reduce overall postprandial glycemia in individuals with type 2 diabetes (t2d).

it was shown that increasing protein at breakfast results in reduced overall postprandial glycemia in obese individuals this study was undertaken to evaluate whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast is more effective to reduce overall postprandial glycemia (pphg) in t2d individuals.

Eligibility criteria:
inclusion criteria: 1. participants: from 30 to 72 years of age 2. bmi: 26 to 34 kg/m2) 3. diabetes criteria 4. hba1c: 7-9 % or 5. habitually eat breakfast 6. only naïve or treated with metformin. 7. not dieting and no change in body weight \>10 lb = 4.5 kg within the last 3 months 8. normal liver, kidney and thyroid function. exclusion criteria: 1. type 1 diabetes 2. anemia (hg \> 10 g/dl) 3. serum creatinine level \< 1.5 mg/dl 4. pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery. 5. abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate 6. infectious disease 7. pregnant women or lactating 8. known hypersensitivity to milk components 9. documented or suspected history (within one year) of illicit drug abuse or alcoholism.
effects of soft tissue mobilization of neck muscles in individuals with myogenous temporomandibular disorders: muscle energy technique and strain-counterstrain

Conditions: Myogenous Temporomandibular Disorders (mTMD)

Summary: this is a prospective case series study.there were 20 individuals with chronic neck pain accompanied by myogenous temporomandibular disorders(mtmd) from linkou and taoyuan chang gung hospitals, and chang-gung university. the purpose of this study was, first, to investigate the effects of muscle energy technique (met) or strain-counterstrain (scs) applied on the tender or trigger points of neck muscles on improving pain and pressure pain sensitivity in neck and masticatory muscles, the maximal mouth-opening range of motion, chewing endurance, and head-neck-shoulder posture in patients with chronic neck pain accompanied by mtmd. second, whether the significant effects could be reached within the four-week intervention duration.


Eligibility criteria:
inclusion criteria: * aged 20\~65 * self-report neck pain ≥3 months (pain occurs between superior nuchal line and 1st level of thoracic spine) * at least one tender point at both upper trapezius and sternocleidomastoid muscles * diagnosed as mtmd according to the diagnostic criteria for temporomandibular disorders(dc/tmd) exclusion criteria: * cognitive deficit * malignancy, infection, cervical or orthognathic surgery, acute pain, and history of trauma in craniocervical region * neurological problem or cervical radiculopathy/myelopathy * cervical instability with positive rotational alar ligament stress test and transverse ligament stress test, jaw dislocation * tooth implantation or extraction a week before study * vertebrobasilar insufficiency

Keywords: myogenous temporomandibular disorders, neck pain, muscle energy technique, strain-counterstrain, head-neck posture
study comparing a generic diclofenac sodium topical gel, 1% to voltaren in the treatment of subjects with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: to establish the therapeutic equivalence and safety of a generic diclofenac sodium topical gel, 1% with voltaren® gel 1% in subjects with osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of oa of the knee. * had an x-ray of the target knee, taken no more than 1 year before baseline, showing evidence of oa with kellgren-lawrence grade 1-3 disease. * after discontinuing all pain medications for at least 7 days, has at least moderate pain on movement for target knee * if female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study * able to tolerate rescue medication with paracetamol/acetaminophen. exclusion criteria: * pregnant or lactating or planning to become pregnant during the study period. * x-ray showing evidence of oa with kellgren-lawrence grade 4 disease. * history of oa pain in the contralateral knee requiring medication within 1 year prior to screening. * after discontinuing all pain medications for at least 7 days, has a baseline score of ≥20 mm on a 0-100 mm visual analog scale (vas) for the contralateral knee immediately prior to randomization. * history of secondary oa, rheumatoid arthritis, chronic inflammatory disease or fibromyalgia. * history of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease. * history of gastrointestinal bleeding or peptic ulcer disease. * use of warfarin or other anticoagulant therapy within 30 days of study randomization. * elevated transaminases at screening. * use of ace inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of study randomization. * concomitant use of corticosteroids or use within 30 days of study randomization. * concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis taken for at least 3 months prior to enrollment and maintained throughout the duration of the study. * known allergy to aspirin or nonsteroidal anti-inflammatory drug * any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study. * receipt of any drug as part of a research study within 30 days prior to screening. * previous participation in this study. * any use between screening and baseline of a treatment or medication that may potentially confound study assessment that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs). * recent history of major knee injury or surgery. * known history of positive hiv

Keywords: knee