Kornimate/medical-research-clean huggingface dataset:
randomized comparison of the abbott whitestar signature system with ellips tranversal ultrasound vs. the alcon infiniti with the ozil torsional handpiece in phacoemulsification: a contralaterally-controlled trial

Conditions: Cataracts; Astigmatism

Summary: the purpose of this study is to look at the outcomes of your vision after your cataract surgery based on two different types of equipment that will be used during your surgery.


Eligibility criteria:
inclusion criteria: * patients at least 21 scheduled to undergo bilateral phacoemulsification with implantation of multifocal iols. * both eyes must have similar degrees of cataract and astigmatism (topographic cylinder difference of \<2.00d as well as similar globe axial length as measured by the iol master of \<0.5mm). * visual potential of ucva 20/25/ or better. * clear intraocular media other than cataract. exclusion criteria: * clinically relevant differences between eyes in ocular disease or pathology. * presence of glaucoma, macular disease, or foveal disease to an asymmetrical degree. * asymmetrical use of ocular medications.
camapi for adolescents/young people with a history of self-harm and suicidal ideation in jos, nigeria

Conditions: Self-harm; Suicidal Ideation

Summary: suicide and self-harm are global disease burden that contributes significantly to years of lost life and mortality.

self-harm and suicidal ideation represent a significant global public health concern (knipe et al., 2022), affecting about 14.6 million people yearly (nichols et al., 2021). globally, over 700 000 people die by suicide annually (world health organization -- who, 2023). suicide is the fourth leading cause of death among 15-29-year-olds, and 77% of global suicides occur in low- and middle-income countries, including nigeria (who, 2023). the psychological impact of suicidal ideation includes continuing high tendencies of self-harm (jidong et al., 2024). despite the increasing rates of suicide and self-harm in nigeria, this topic is understudied, with no culturally appropriate or sustainable psychological interventions.

Eligibility criteria:
inclusion criteria: * patients aged 16-24 years presenting to the participating services, and emergency departments or admitted after an episode of self-harm to the participating hospitals or self-referrals. * participants will have to be living within the catchment area of the participating practices, services and hospitals. * not needing inpatient psychiatric treatment. exclusion criteria: * severe mental illness (such as psychotic disorder). * conditions limiting engagement with assessment/intervention. * temporary resident unlikely to be available for follow up.
companion for car-t web app during chimeric antigen receptor t-cell therapy

Conditions: Lymphoma; Leukemia; Plasma Cell Dyscrasia

Summary: the complex logistics and unique toxicities of chimeric antigen receptor t-cell (car-t) therapy require intensive patient education and careful monitoring. the companion for car-t (cc) web app may be able to assist with patient education and preparation, communication between patients and their multidisciplinary teams, and home-based toxicity monitoring.

this is a single-arm pilot study assessing the feasibility and acceptability of the companion for car-t (cc) web app among patients receiving commercially available car-t therapies. primary objectives: i. to evaluate the feasibility of the cc web app. ii. to evaluate the acceptability of the cc web app to patients. secondary objectives: i. to quantify the incidence of fevers being reported via the cc web app. ii. to quantify the incidence of electronic immune effector cell-associated encephalopathy (eice) deficits being recorded via the cc web app. exploratory objectives: i. to explore patient perceptions regarding the cc web app. ii. to explore usage patterns regarding the cc web app. iii. to explore trends in patient-reported quality of life (qol), values, and stressors over time during car-t therapy. iv. to explore responses to abnormal findings reported or recorded using the cc web app participants will be given access to the web application from beginning at the day of study enrollment through day +100 following car-t therapy.

Eligibility criteria:
inclusion criteria: * diagnosis of a hematologic malignancy (including any plasma cell dyscrasia, any type of lymphoma, or any type of leukemia). * planned receipt of an fda-approved car-t therapy at university of california, san francisco (ucsf) as standard of care. * patient proficiency in spoken and written english. * caregiver proficiency in spoken and written english. * age \>= 18 years old exclusion criteria: * fda-approved car-t therapy being administered as part of a prospective industry-sponsored trial, for example registrational trials of car-t therapy versus salvage chemotherapy or car-t therapy as an off-label line of therapy. \*however, patients who receive an fda-approved car-t therapy through an expanded access program for non-conforming products (or any observational, non-interventional analysis of car-t products) are eligible. * lack of ownership of a personal computing device, tablet device, or smartphone. * refusal of patient and/or caregiver to sign up for a ucsf mychart account. \*participants and caregivers who do not have a mychart account at enrollment but are willing to create one will receive assistance from the study team to do so. * any serious and/or unstable pre-existing medical, psychiatric, or other condition that could - in the opinion of the study's principal investigator (pi) - interfere with provision of informed consent or compliance with study procedures.

Keywords: web application car-t therapy
investigations on differences in atorvastatin metabolites ratios as a diagnostic tool in detecting atorvastatin induced myotoxicity

Conditions: Myotoxicity of Atorvastatin Treatment

Summary: the primary objective of the study is to investigate the ratios of p-hydroxyatorvastatin to atorvastatin in patients receiving atorvastatin treatment, who experience muscle adverse events, to elucidate whether differences in this ratio might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity.

the primary objective of the study is to investigate the ratios of p-hydroxyatorvastatin to atorvastatin in patients receiving atorvastatin treatment, who experience muscle adverse events, to elucidate whether differences in this ratio might have a positive or negative predictive value in diagnosing atorvastatin muscle toxicity. if this is shown, measurements of atorvastatin metabolites from patients experiencing muscle adverse events might be a valuable diagnostic tool to diagnose myopathy associated with statin treatment. the primary endpoint cut off level for present myotoxicity has been set to a ratio of p-hydroxyatorvastatin /atorvastatin of 0.15 from the previously performed pilot study (unpublished data, herman m et al). values at or above this ratio will be considered as clinical significant indicia of statin related myopathy. secondary objectives include descriptively investigation of drug to metabolite cut off ratio for atorvastatin lactone/atorvastatin. whether other cut off values, both for p-hydroxyatorvastatin as well as for atorvastatin lactone, give more precise identification of patients that are experiencing statin related myopathy compared to controls will also be investigated. explorative objectives of the study are to investigate possible in vitro phenotypic differences in isolated muscle cells from patients experiencing muscle toxicity compared to patients not experiencing muscle toxicity. if there are genetic differences between patients experiencing myotoxicity and those not, this difference is likely to show as phenotypic differences in in vitro studies of isolated muscle cells. if such phenotypic differences are present in vitro possible mechanistic causes will be further investigated.

Eligibility criteria:
inclusion criteria: * suspected atorvastatin induced muscle adverse events. * signed informed consent. * 18 years of age or older. * able to donate blood samples.
evaluation of a diabetes treatment and education program for insulin pump therapy (input)

Conditions: Diabetes Mellitus

Summary: this study is a randomized, controlled, prospective trial with a 6-month follow-up. a newly developed treatment and education programme for diabetic patients with an insulin pump therapy (input) will be tested compared to a waiting group. primary outcome variable is the difference in glycemic control between baseline and the 6-month follow-up. secondary outcome variables are: severe hypoglycaemia, diabetes-related distress, depressive symptoms, health-related quality of life, diabetes empowerment, self-care behavior, hypoglycemia awareness, and attitudes towards insulin pump therapy.

input is a self-management-based treatment and education program for diabetic patients with an insulin pump (csii). it is designed to empower patients to adequately perform their therapy in daily life and to integrate their diabetes and their insulin pump into their lifes in order to enhance quality of life. input ist tested in an randomized controlled trial (rct) with a waiting-list control group since no certified and effective treatment and education program for csii exists. this study is a multi-center study. study centers are specialized diabetes practices throughout germany. patients will be approached by their respective practice and informed about the study. study measurements as well as the conduct of input will take place at the respective practice. baseline measurement will take place 2 weeks prior to the beginning of input. after completion of baseline measurement, all patients from one study center will be randomized centrally by the research institute of the diabetes academy mergentheim (fidam). 2 weeks and 6 months after the completion of input, follow-up measurements will be conducted at the respective study center. hba1c as a marker of glycemic control will be analyzed in a central laboratory. secondary outcome measures will be assessed via psychometrically tested questionnaires, case reports forms, or patient files.

Eligibility criteria:
inclusion criteria: * existing insulin pump therapy * prior participation in a structured diabetes education program * hba1c ≥ 7,5% but ≤ 13% * ability to understand, speak and write german language * informed consent (if necessary, informed consent of the parents) exclusion criteria: * diabetes duration \< 1 year * severe organic disease preventing a regular participation in the training course * pregnancy * severe cognitive impairment * current treatment of psychiatric disorder * renal disease requiring dialysis

Keywords: self-management empowerment treatment and education program insulin pump diabetes education
16α-18f-fluor-17β-estradiol pet/ct for visualisation of estrogen receptor positive liver metastases from breast cancer

Conditions: Breast Cancer

Summary: breast cancer (bc) is the most common cancer diagnosis among women and the incidence is increasing. prognosis and treatment are dependent on the expression of estrogen receptors (er) in the tumor. er status is determined by immunohistochemistry (ihc) on biopsy tissue. the er expression can change over time and be heterogeneous. the ihc score on er expression is subjective and can lead to intra and inter observer variability. a new computer image analysis software that can give the exact percentage of colored tumor cells on sectional tumor cuts has been developed. it is also possible to quantify the er expression non invasive by using the tracer 16α-18f-flour-17β-estradiol (fes) and in vivo positron emission tomography (pet) scans. fes-pet/ct has a high background activity in the liver which complicates the visualization of liver metastases. theoretically, a new whole body parametric scan method makes it possible to distinguish background activity from uptake in liver metastases. malignant tumors often have an increased perfusion, and previous studies have found that tumors with low metabolism relative to blood flow have the longest disease free survival (dfs). to the best of our knowledge, no previous studies have examined the correlation between er expression and blood flow.


Eligibility criteria:
inclusion criteria: * patients with known disseminated breast cancer * metastatic er+ her2- breast cancer with metastases in the liver, at least two separate liver foci visualised on ct * diagnostic ct scan done in connection with clinical control * treatment with aromatase inhibitors, and potential additional treatment * postmenopausal exclusion criteria: * treatment with tamoxifen or fulvestrant completed within 5 weeks prior to fes-pet/ct * er- metastases * life expectancy under three months * claustrophobia * any pain which makes it impossible to lie in the scanner for 90 minutes

Keywords: breast cancer liver metastases fes-pet/ct dynamic scan
cqdsa in evaluation of prognosis after evar

Conditions: Endoleak; Aortic Aneurysm, Abdominal

Summary: re-hospitalization or re-intervention is sometimes necessary to treat type i and type iii endoleaks after evar for its persistent increasing of pressure in aneurysm lumen. color-coded quantitative digital subtraction angiography (cqdsa) provides an easy and quick way to post-process the traditional digital subtraction angiography (dsa) which converts the peak time of the maximal contrast medium intensity into a single polychromatic image. with the help of cqdsa, a quantitative evaluation of the endoleak hemodynamics and a risk analysis of the type i or type iii endoleak could be performed during the evar procedure. this approach may offer an objective assessment of the needs for immediate re-intervention, conservative therapy or treatment endpoint in the future.

intra-procedural dsa series are transferred to a research workstation to generate the color-coded images and make quantitative measurements. region of interest (roi) measurements are performed equivalently in the endoleak and the aorta after the image generation. there are three kinds of rois including a small circle area with the shortest time to peak, a circle area with peak contrast intensity and the whole endoleak area. the roi and a reference at the same latitude within the aorta are selected to undergo measurement which reflected the endoleak hemodynamics of the endoleak to the utmost extent. the following parameters will be acquired through the cqdsa for analysis. 1. time-versus-roi contrast intensity graph. the graph contains one endoleak roi flow curve and one reference aortic flow curve (ref). the x-axis shows time from 0 second to the maximum frame time of the image. the y-axis shows the sum of pixel intensities, namely total contrast, representing the contrast concentration within the roi. 2. roi peak/ref peak. it is the ratio of intensity peak between the endoleak and the reference in the aorta. 3. roi ttp (time to peak). peak time of roi in the vicinity of endoleak entry. 4. roi auc/ref auc. area under curve (auc) is calculated through time-versus-roi contrast intensity graph. the parameter here is the ratio of roi auc in endoleak to the reference.

Eligibility criteria:
inclusion criteria: * patients who present type i or/and type iii endoleak after evar for aaa and complete at least 3 months' follow up. exclusion criteria: * patients who 1. undergo surgeries which involve the segment covered by evar; 2. present connective tissue disease, such as marfan's syndrome or vasculitis. 3. present abdominal aortic dissection. 4. present aaa rupture. 5. die from non aneurysm-reltated reasons or are lost during follow up.

Keywords: endoleak evar aaa cqdsa
assessing the diaphragm before and after endobronchial valve treatment

Conditions: Emphysema

Summary: rationale: the diaphragm is the principal respiratory muscle, which separates the thorax from the abdomen. hyperinflation of the lung places the diaphragm at a mechanical disadvantage, shortens its operating length and changes the mechanical arrangement of costal and crural components of the diaphragm and consequently decrease the tension that can be developed and the amount of transdiaphragmatic pressure that can be produced. reducing the lung hyperinflation could improve the diaphragm function mechanically. one of the treatments to reduces lung hyperinflation is the bronchoscopic treatment using endobronchial valves. to our knowledge the change in diaphragm function after bronchoscopic endobronchial valve treatment was never investigated. objective: to investigate the change in diaphragm function after bronchoscopic lung volume reduction treatment with endobronchial valves (ebv). study design: observational study in which the study population will be asked to perform some additional test during regular visits for the bronchoscopic lung volume reduction treatment with valves. main study parameters: change in diaphragm function 6 week after ebv treatment measured by ultrasound. the main outcome will be diaphragm motion (difference between maximum in- and expiration).


Eligibility criteria:
inclusion criteria: 1. patient is scheduled for a bronchoscopic lung volume treatment using one-way valves 2. patient read, understood and signed the informed consent form exclusion criteria: there are no exclusion criteria for this study.
does delaying curative surgery for colorectal cancer influence long-term disease free survival.

Conditions: Colorectal Cancer

Summary: this work is an original clinical research article describing the relationship between wait list tome for colorectal cancer patients and long-term survival. these findings are particularly relevant for management of surgical wait lists during crisis such as the covid-19 pandemic. the lack of a relationship between wait list time and disease free survival and tendency for improved survival in the 4-6 week imply some colorectal cancer operations can be safely delayed during times of limited resources.

background surgical wait list time is a major problem in many health-care systems and its influence on survival is unclear. the aim of this study is to assess the impact of the wait list time on long term disease-free survival in patients scheduled for colorectal cancer resection. materials and methods a prospective, single center study was carried out in patients with stage i-iii colorectal cancer scheduled for surgery between 2012-2017 at a colorectal surgery unit of a tertiary care center. wait list time was defined as the time from completion of diagnostic workup and definitive surgery and divided into 2-week intervals from 2 to 6 weeks. the outcome variables were 2- and 5-year disease free survival. screening for disease progression was with carcinoembryonic antigen levels and chest/abdominal computed tomography scan. data was collected prospectively and subsequently analyzed.

Eligibility criteria:
inclusion criteria: * american joint committee on cancer (ajcc) stage i through iii confirmed adenocarcinomas * with "colon" or "upper rectum" as their primary site of malignancy according to international classification of diseases for oncology, third edition topography code. exclusion criteria: * emergency surgery, * more than one primary site, * synchronous metastasis or peritoneal carcinomatosis at the time of surgery * if they received neoadjuvant chemoradiotherapy * if they had a local transanal excision.
bioimpedance spectroscopy compared to cardiomems™

Conditions: NYHA Class III Heart Failure

Summary: comparison of changes in diastolic pulmonary artery pressure as measured by cardiomems™ to impedance parameters as measured by impedimed's bis technology.

this is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a cardiomems™ device implanted to monitor their diastolic pulmonary artery pressure. the study will recruit and enroll ten participants from the scripps clinic. participants will be monitored 3 times a week for a period of 4 weeks. at each monitoring visit, the patient's diastolic pulmonary artery pressure will be measured by cardiomems™ and the impedimed's bis technology. participant's vital signs and weight will also be taken at each monitoring visit.

Eligibility criteria:
inclusion criteria: patient: 1. has an cardiomems device implanted 2. has been diagnosed with various stages of heart failure as described by new york heart association (nyha) 3. is able to give informed consent exclusion criteria: patient: 1. has pacemaker/icd 2. is pregnant or breastfeeding 3. is an amputee 4. has been diagnosed with multiple medical conditions that would make participation burdensome 5. not able to co-operate with impedance measurements

Keywords: bioimpedance spectroscopy
exercise training and hepatic metabolism in overweight/obese adolescent

Conditions: Obesity; Metabolic Syndrome X; Lipid Metabolism Disorders; Body Composition, Beneficial; Mental Health Wellness 1

Summary: the hepafit study aims to examine whether a 6-months physical education program has benefits on hepatic metabolism and cardiovascular health as well as on selected physical fitness and mental health outcomes among adolescent overweight/obese from bogota, colombia.


Eligibility criteria:
inclusion criteria: * overweight or obesity status * 11-17 years old * written informed consent * interested in improving health and fitness exclusion criteria: * any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial. * clinical diagnosis of diabetes * pregnancy * drugs/alcohol abuse
coronavirus-19 (covid-19) and related outcomes in school aged children (abc health outcomes in children)

Conditions: Covid19; MIS-C

Summary: this is a prospective, observational study with a primary objective of determining the incidence of non-severe and severe covid-19, including mis-c, among eligible children who are diagnosed with covid-19 and consent (or assent) to collection of data on risk factors using a unique direct-to-participant, direct-to-family, and direct-to-community approach. secondary and exploratory objectives include risk factors of severe disease and quality of life (qol).


Eligibility criteria:
inclusion criteria: * participant is ≤ 21 years of age at time of enrollment * participant or their parent/guardian has downloaded the "abc science" app from the app store as a part of the abc science collaborative (pro00107785) and has agreed to the app's terms of use * participant has a positive covid-19 diagnosis, defined as one or more of the following: 1. a positive covid-19 test; or 2. clinical diagnosis of covid-19 based on symptoms, as documented by a medical provider, in the absence of a positive influenza test; or 3. retrograde diagnosis based on presence of covid-19 antibodies exclusion criteria: * n/a