Kornimate/medical-research-clean huggingface dataset:
dual antiplatelet therapy escalation from standard-dose clopidogrel to low-dose prasugrel in patients with high bleeding and ischemic risk undergoing pci: a prospective, randomized pharmacodynamic study (tailor-bleed-2)

Conditions: Coronary Arterial Disease (CAD); Percutaneous Coronary Intervention (PCI)

Summary: the primary aim of this study is to investigate the pd effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (hbr defined as the hbr-arc criteria and hir defined as abcd-gene score ≥10) following pci. we hypothesize that in patients at dual-risk, switching from standard-dose clopidogrel to low-dose prasugrel will be superior to continuing standard-dose clopidogrel in terms of platelet reactivity.


Eligibility criteria:
inclusion criteria: * patients with high bleeding risk (defined according to the arc-hbr criteria) who have undergone pci and are on maintenance treatment with dapt, consisting of low-dose aspirin (81mg qd) with clopidogrel (75 mg qd) as part of standard of care for at least 30 days. * age ≥18 years. * provide written informed consent. exclusion criteria: * prior cerebrovascular event. * pci within 30 days. * hemodynamic instability. * on treatment with any oral anticoagulant (vitamin k antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis). * hypersensitivity to aspirin, clopidogrel, or prasugrel. * known hematologic malignancies or thrombocytopenia (platelet count \<80x106/ml). * known hemoglobinopathies or anemia (hemoglobin \<9 g/dl) * pregnant and breastfeeding women \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\].

Keywords: coronary artery disease dual antiplatelet therapy high bleeding risk
immune checkpoint inhibitors (icis) retreatment in second-line treatment of advanced gastric cancer: a retrospective, real-world study

Conditions: Gastric Cancer, Gastroesophageal Junction Cancer; Immune Checkpoint Inhibitors (ICIs); Second-line; Retreatment

Summary: this is a single-center, retrospective, observational, real-world study. we collected general and clinical data of patients with advanced gastric cancer who were admitted to the first affiliated hospital of zhengzhou university from january 2018 to july 2024.

all patients received combination therapy with icis inhibitors for at least 2 cycles in the first-line and at least 2 cycles of ici inhibitor-based therapy in the second-line after first-line progression. the efficacy and safety of treatment were evaluated, including overall survival (os), progression-free survival (pfs), objective response rate (orr), disease control rate (dcr), pattern of immune progression after cross-line therapy, grade 3-5 treatment-related adverse events (traes), and immune-related adverse events (iraes). cox regression model was used to investigate the influence of multiple factors on survival.

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic or advanced gc/gejc; * received at least 2 cycles of anti-pd-1 or pd-l1 based therapy in the first-line setting; * receiving at least 2 cycles of ici-based second-line therapy; * ecog ps 0 or 1; * radiographic response was also assessed during treatment and survival. exclusion criteria: * patients had other malignancies within the past 5 years; * lack of survival and clinical efficacy data; * combined radiotherapy regimens in the second-line treatment.
online imaginal exposure

Conditions: Eating Disorder; Exposure; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Therapy

Summary: this study evaluates if imaginal exposure therapy can decrease symptoms of eating disorders and anxiety, and test an online format of ie to maximize its ability to reach as many individuals with eating disorders as possible. all participants will complete four imaginal exposure sessions and will complete questionnaires prior to receiving this treatment, as well as complete follow up questionnaires at 1-month, 6-month, and 12-month.

eating disorders (eds) are tenacious mental disorders that are difficult to treat. eds are often accompanied by anxiety disorders, which exacerbate the problem. better ed treatments are imperative, and it is likely that targeting comorbid conditions, such as anxiety, will facilitate ed treatments. imaginal exposure is used in anxiety disorders to face fears that are not accessible or practical to address via in-vivo exposures. for example, a patient with ptsd cannot re-experience her trauma in real life, but she can imagine the past trauma and experience the subsequent anxiety. for patients with an, catastrophic outcomes such as abandonment or immediate fatness are similarly impossible to recreate as in-vivo exposures. patients cannot become fat solely for the purpose of the exposure, but they can imagine what it would be like to become fat. the investigators are unaware of any literature using imaginal exposure therapy to induce fears of fatness and conducted a case study to test whether imaginal exposure could, firstly, induce fears of fatness and then promote reduction in anxiety and eating disorder symptoms. in this case study, the investigators found that imaginal exposure therapy was effective at reducing anxiety and eating disorder behaviors. imaginal exposure therapy (ie) has been shown to be an extremely effective treatment for post-traumatic stress disorder. ie has also been shown to be effective for the treatment of eating disorders using case studies. however, ie has not been systematically applied to the eating disorders. the purpose of this study is to test if 1) imaginal exposure therapy can decrease symptoms of eating disorders and anxiety, and 2) test an online format of ie to maximize its ability to reach as many individuals with eating disorders as possible.

Eligibility criteria:
inclusion criteria: * at least 14 years of age (no age limit) * currently meet criteria for an eating disorder (using the eating disorder diagnostic scale), or have met criteria for an eating disorder in the last year, or endorse significant eating disorder fears * at least one significant eating disorder related fear. exclusion criteria: * under 14 years of age * do not meet eating disorder related criteria * do not meet criteria for mania, psychosis, or suicidal ideation will be excluded.
prospective evaluation of bleeding risk of anticoagulant and anti-platelet therapy

Conditions: Bleeding

Summary: this study will evaluate bleeding risk and differences in outcomes in patients receiving and not receiving anticoagulant or antiplatelet therapy

1. to evaluate bleeding risk in interventional procedures in patients with or without antiplatelet and/or anticoagulant therapy. 2. to evaluate differences in outcomes in patients not receiving any anticoagulant or antiplatelet therapy compared to patients receiving various types of drugs with anticoagulant or antiplatelet therapeutic effects. 3. to evaluate and compare the adverse event profiling all patients.

Eligibility criteria:
inclusion criteria: * subjects undergoing interventional techniques. subjects who were able to give voluntary, written informed consent. exclusion criteria: * all those things, patients on heparin, dextran, and low molecular heparin
assessing the efficacy of needling with or without corticosteroids in the repigmentation of vitiligo

Conditions: Vitiligo

Summary: vitiligo is an autoimmune cutaneous disorder that destroys melanocytes leading to depigmented areas of skin. in the united states, vitiligo affects 1% of patients, causing not only changes in the color of skin, but also significant cosmetic concerns and quality of life issues. current treatment modalities, which include topical corticosteroids, intralesional corticosteroids, phototherapy, and systemic immunosuppression, are variably effective in inducing repigmentation. unfortunately, some cases of vitiligo are refractory to treatment. there is a need for new, effective modalities to treat patients with otherwise refractory vitiligo. needling is an office based procedure that theoretically transposes healthy, pigmented skin cells to depigmented areas using a needle in vitiligo patients. two preliminary studies of needling as a novel treatment for vitiligo had promising results but were limited by small sample size and subjective results. the proposed randomized control trial (rct) will further investigate the use of needling to treat vitiligo. it differs from the previous studies in that it seeks to identify the cause of clinical benefit by comparing needling alone to needling with corticosteroid, examines a larger number of patients, and quantifies improvement using confocal microscopy. confocal microscopy (cfm) allows non-invasive visualization of the skin on a cellular level and has been used in the past to diagnose cutaneous pigmentary conditions. this study would be the first rct of needling in vitiligo to use an objective measure to quantify results, thus has the potential to establish needling as a novel, effective treatment for vitiligo and to evaluate the utility of cfm for monitoring response to treatment.


Eligibility criteria:
inclusion criteria: * 1. patients with 3 or more localized patches of stable vitiligo * 2. no prior treatment or had failed previous vitiligo treatments exclusion criteria: * 1. unstable vitiligo * 2. allergic to triamcinolone * 3. systemic treatments * 4. pregnancy
effect of health education intervention on promoting healthy lifestyles for undergraduate female students in saudi arabia

Conditions: Obesity; Physical Inactivity

Summary: according to the world health organization (who), saudi arabia has seen a more astonishing rise in obesity. young females have a considerable prevalence of unhealthy dietary practices and lack of knowledge about healthy and energy-dense foods. additionally, in saudi arabia, the levels of physical inactivity ranged from about one-third to as high as 70% of the population. the current study aims to determine the effects of combined health education and motivational message intervention on promoting healthy lifestyles and body composition markers for undergraduate female students who suffer from obesity at northern border university in the kingdom of saudi arabia.

a cluster randomized controlled study will be conducted among 250 undergraduate female students aged (18-24) in northern border university. the intervention and control faculties will be selected and allocated randomly. the intervention group will have six weeks of fortnightly six sessions (45 minutes), while the control group will have their regular curriculums and normal physical activity routine. the research instruments include socio-demographic characteristics, anthropometric measurements, and questionnaires about knowledge, attitude, and practice of obesity, physical activity, dietary intake, dietary quality, diet and eating behaviour, and disordered eating. data will be collected from intervention and control groups at baseline, post-intervention, and 3-month follow-up after the intervention. data will be analyzed by using the (spss) software version 26. descriptive statistics will be used to distribute and summarize the data. a generalized estimating equation (gee) will be used to test the effect of the intervention program for the selected variables (outcomes) between and within the group at baseline, six weeks, and one month after intervention, which is adjusted for clustering.

Eligibility criteria:
inclusion criteria: * female undergraduate students. * saudi students. * aged between 18-24 years. * categorized with a bmi greater than 25. exclusion criteria: * pregnant students * students with diseases on treatment such as asthma, diabetes, cancer, cardiovascular diseases, fractures, cirrhosis, or other diseases. * students with any medical condition who not allowed to do physical activity.
rbc irradiation, anemia and gut injury

Conditions: Anemia; Necrotizing Enterocolitis

Summary: the purpose of this trial is to study the effect that anemia and red blood cell (rbc) transfusions have on oxygen levels in the digestive tracts of extremely low birth weight (elbw) infants and to look for possible markers in a baby's blood, urine and/or stool that may lead to a better understanding of what makes an elbw infant at risk for digestive tract problems such as necrotizing enterocolitis.

anemia and digestive tract complications are common problems in extremely low birth weight infants. anemia is a condition in which the body does not have enough red blood cells (rbc). rbcs are important because they contain hemoglobin, the substance that carries oxygen throughout the body. transfusions of rbcs in these infants is frequently required to correct the anemia. oxygen levels in the digestive tract will be measured before, during and after each blood transfusion using a tissue oxygen monitor called near infrared spectroscopy (nirs). by using this technology, better understanding can be obtained of intestinal blood flow patterns. in addition, elbw infants are more likely to have immature digestive systems and are at risk for digestive tract problems such as necrotizing enterocolitis (nec). nec is a disease characterized by infection and decreased blood flow to the intestines. nec is a major cause of devastating illness and death in this vulnerable preterm population. leftover blood samples, urine, stool, and breast milk samples will be collected, frozen, and stored. in the event a baby develops a digestive tract complication they will be studied in a laboratory to identify markers that indicate a healthy digestive tract versus illness.

Eligibility criteria:
inclusion criteria: * birth weight ≤1250 grams * postnatal age within 7 days of birth exclusion criteria: * infant not expected to live beyond 7 days of life based on assessment of treating neonatologist * severe congenital abnormality expected to affect life expectancy * rbc or platelet transfusion at an outside institution occurring prior to screening * maternal refusal to participate

Keywords: red blood cell transfusion digestive tract problems extremely low birth weight
non-invasive measuring of cerebral perfusion after severe brain injury with near-infrared-spectroscopy and icg

Conditions: Subarachnoid Hemorrhage, Aneurysmal; Intracerebral Hemorrhage (ICH); Traumatic Brain Injury

Summary: the purpose of this study is to show if it is possible to detect secondary ischemic events in patients with severe brain injury or cerebral haemorrhage with the help of non-invasive near-infrared spectroscopy (nirs) by using the indocyanine green measuring of cerebral perfusion.


Eligibility criteria:
inclusion criteria: * patients over 18 years * onset of clinical symptoms of subarachnoid or intracranial haemorrhage or trauma suffered less than 72h * indication for implanting a tissue oxygen and intracranial pressure probe * a signed informed consent by the patient or legal guardian exclusion criteria: * persistent epidural, subdural or subcutaneous hematoma in planned area of the nirs optode * open injuries in the area of the planned optodes * malignant primary disease under chemotherapy * pregnancy * bleeding disorder * in the short term unfavorable prognosis (eg, bilateral wide and light-fixed pupils) * patients with pacemakers or where no mri compatibility is due to non- removable metal parts * contraindications for contrast media in ct (eg, iodine allergy) * untreated hyperthyroidism * end stage renal disease * severe psychomotor agitation

Keywords: subarachnoid hemorrhage near-infrared-spectroscopy indocyanine green secondary ischemia
evaluation of balloon-based cryoablation of human esophageal epithelium

Conditions: Barrett's Esophagus; Esophageal Cancer

Summary: the purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.

the purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. the performance and safety of the cryoablation technique will also be evaluated.

Eligibility criteria:
inclusion criteria: * patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. a patient may be treated with up to 2 zones of ablation. * patient is 18 to 80 years of age at the time of consent (inclusive). * patient has provided written informed consent form (ifc) using a form that has been approved by the institution's reviewing irb/ec. * patient is willing and able to comply with all clinical investigation plan (cip) requirements. * patient's esophagectomy is clinically necessary due to reasons unrelated to this study. * patient is deemed operable per standard institutional criteria. exclusion criteria: * patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to ifc, post treatment instructions or follow-up guidelines. * patient refuses or is unable to provide written informed consent. - - * patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation. * patient has esophageal narrowing limiting access to the intended site of ablation. * patient is undergoing or has recently undergone chemotherapy (within 15 days or wbc below normal by institutional criteria or standards). * patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or wbc below normal by institutional criteria or standards).

Keywords: esophagectomy barrett's esophagus
spectral focused imaging versus white light imaging in colorectal adenoma detection

Conditions: Colorectal Adenoma

Summary: spectral focused imaging (sfi) is newly developed image-enhancing endoscopy technology that enhances the contrast of target tissue structures while improving color contrast because spectral signal energy is further concentrated on the absorption peak wavelength of microvessels by using digital spectral processing techniques. this technology, combined in the latest generation sonoscape\&#39;s endoscopes (sonoscape co, shenzhen, china) with new high-performance led illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. data available regarding colorectal polyp or adenoma detection with sfi are encouraging but are scanty and limited to back-to back studies. this two parallel arms, randomized, multicenter trial is aimed at evaluating whether sfi is superior to wli endoscopy in terms of adenoma detection

45-85 years-old subjects participating in their first colonoscopy and meeting all eligibility criteria are randomised 1:1 to sfi (sfi group) or wli (wli group) during insertion and withdrawal phase of colonoscopy. all procedures are performed with a high-definition hd-580 series videocolonscopes with or without magnification (sonoscape co, shenzhen, china). the primary outcome measure is the adr, defined as the proportion of participants with at least one adenoma (per-patient analysis).

Eligibility criteria:
inclusion criteria: * 1. male or female aged 45 to 85 * 2. patients undergoing colonoscopy for the first time due to colorectal cancer screening, having positive fecal immunochemical test (fit) results, or experiencing gastrointestinal symptoms * 3. capable of providing informed consent and agreeing to participate * 4. able and willing to follow all research processes exclusion criteria: * 1. participated in other clinical trials, signed informed consent form, and in the follow-up period of other clinical trials; * 2. participated in clinical trials of drugs and is in the discontinuation period of experimental or control drugs; * 3. pregnant or lactating patients; * 4. known to have polyposis syndrome; * 5. patients with gastrointestinal bleeding; * 6. previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery; * 7. patients with contraindications to tissue biopsy; * 8. history of allergies to the ingredients in intestinal cleansers; * 9. individuals with conditions such as intestinal obstruction or perforation, toxic megacolon, heart failure (grade iii or iv), severe cardiovascular disease, severe liver failure, or renal insufficiency, among others. * 10. researchers believe that patients are not suitable to participate in the trial; * 11. have had drug or alcohol abuse or psychological disorders in the past five years.

Keywords: spectral focused imaging colorectal adenoma adr
determination of accuracy in measurement of total immunoglobulin e using a test device in atopic subjects

Conditions: Atopic Asthma

Summary: the purpose of this study is to determine the accuracy of the novel point of care test (poct) total ige assay in atopic patients. 120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled. fingerstick capillary blood samples will be collected and tested in the poct device. venous samples will be collected and sent to a reference laboratory for measurement of serum total ige using the reference immunoassay method.


Eligibility criteria:
inclusion criteria: atopic patients * subjects who are diagnosed with atopic condition * subjects or legal guardians who are able to give informed consent * other protocol-defined inclusion criteria may apply exclusion criteria: atopic patients * subjects who have received anti-ige antibody treatment * subjects who have elevated ige levels for reasons other than allergic conditions * other protocol-defined exclusion criteria may apply inclusion criteria: healthy subjects * subjects who are able to give informed consent for participation in the study according to local requirements / law. exclusion criteria: healthy subjects * subjects who have received anti-ige antibody treatment * subjects with a suspected or confirmed clinical diagnosis of an atopic condition * other protocol-defined exclusion criteria may apply

Keywords: total ige measurement novel point-of-care test device atopic conditions in vitro diagnostic test