Kornimate/medical-research-clean huggingface dataset:
prospective validation of an ehr-based pancreatic cancer risk model

Conditions: Pancreatic Adenocarcinoma; Predictive Cancer Model

Summary: the goal of this prospective observational cohort study is to validate a previously developed pancreatic cancer risk prediction algorith (the prism model) using electronic health records from the general population. the main questions it aims to answer are: * will a pancreatic cancer risk model, developed on routine ehr data, reliably and accurately predict pancreatic cancer in real-time? * what is the average time from model deployment and risk prediction, to the date of pancreatic cancer development and what is the stage of pancreatic cancer at diagnosis? the risk model will be deployed on data from individuals eligible for the study. each individual will be assigned a risk score and tracked over time to assess the model's discriminatory performance and calibration.

to prospectively validate, implement in real-time, and assess performance of an ehr- based pdac risk-prediction model. to test the hypothesis that our model will reliably predict pdac in a real-time clinical setting, we will conduct a multi-center prospective cohort study, deploying the pdac risk model within the trinetx federated network database, and will take the following steps: i) generate a risk prediction score for each individual under the care of 44 health care organizations (hcos) in the usa ii) follow all individuals for up to 3 years to assess the primary end-point of pdac development. the following metrics will be used to test the discriminative performance and calibration of the ehr-based pdac risk model in predicting incident pdac, at the end of the 3-year period: 1. auroc, sensitivity, specificity, ppv/npv for assessing discrimination 2. calibration: for assessing the accuracy of estimates, based on the estimated to observed number of events

Eligibility criteria:
inclusion criteria: * male and females age \>= 40 years from 44 us hcos from the trinetx platform * at least 2 clinical encounters to the hco, within the last year, before the study start date exclusion criteria: * personal history of pdac or current pdac * age below 40 notes on sampling method: no sampling was performed. all eligible individuals are included in this study.
a multicenter, prospective blood collection study in a kidney transplant population

Conditions: Kidney Disease; Kidney Transplant; Transplant Recipient; Renal Function; Cell-free DNA

Summary: the purpose of this research is to collect blood samples and data from kidney transplant patients. the blood will be used for research and development of non-invasive test to detect donor-derived cell-free dna (dd-cfdna) in kidney transplant patients to evaluate the status of the transplanted organ.

this is a prospective, multicenter sample collection study within a kidney transplant population. whole blood samples and clinical data will be obtained from each participant at the time of indication biopsy (prior to the biopsy procedure). de-identified leftover retrospective gdna screening samples from each participant (recipient) and paired donor(s) will be obtained.

Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent 2. is 18 years of age or older at enrollment 3. had a kidney transplant prior to enrollment 4. is having an indication biopsy as determined by clinician 5. retrospective leftover samples are available from the recipient and the kidney donor(s). exclusion criteria: 1. is pregnant 2. had a blood transfusion within the past 4 weeks 3. had a transplant from an identical (monozygotic) twin 4. had transplants of multiple organs from the same donor (eg, kidney and liver transplant). 5. had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant) 6. had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)
exercise in older women with breast cancer during systemic therapy

Conditions: Breast Cancer

Summary: breace is a prospective randomized controlled trial. the aim is to investigate the effect of an exercise-based intervention among older participants with breast cancer treated with adjuvant or first-line systemic therapy. the hypotheses: that the intervention will maintain or increase physical function levels, reduce symptoms and side effects, improve quality of life and psychological wellbeing, and prevent weight loss and muscle wasting


Eligibility criteria:
inclusion criteria: participants must: * be operated for primary breast cancer within 12 weeks or * be diagnosed with locally advanced or metastatic breast cancer. be treated with (neo)adjuvant or first or second-line palliative therapy defined as chemotherapy ± her2 directed treatment, ± antihormonal treatment, antihormonal treatment ± her 2, directed treatment ± cdk 4/6 inhibitor. * be ≥ 65 years of age at the time of signing the informed consent form * have an eastern cooperative oncology group (ecog) performance status score ≤ 2 * be able to speak and read danish, and to provide a signed informed consent form. exclusion criteria: participants with: * any physical condition that hinder the execution of physical exercise training * other types of cancer * documented and uncontrolled brain metastases that hinder participation in an exercise-based trial, based on the referring oncologist's assessment * dementia, psychotic disorders, or other cognitive diseases or conditions that hinder written consent * unstable medical disease or history of serious or concurrent illness; any medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted congestive heart failure (nyha class iii-iv), unstable angina pectoris, implantable cardioverter defibrillator (icd), or myocardial infarction within 6 months, based on the referring oncologist's assessment. in patients with documented bone metastases: - a bone metastatic burden or location that poses a risk of injury in the performance of exercise training, as assessed by the referring oncologist.

Keywords: exercise older resistance training breast cancer
use of narrative voice and introduction content to improve interactive voice response surveys in bangladesh and uganda

Conditions: Surveys and Questionnaires; Noncommunicable Diseases

Summary: this study evaluates the effect of two different narrative voices (one male and one female) and two different introductions (one with informational content and the other with additional motivational content) on interactive voice response (ivr) survey cooperation, response, refusal, and contact rates, as compared to a control group (male, informational), in bangladesh and uganda.

using random digit dialing (rdd) sampling techniques, participants were randomized to one of four arms: 1) male narrator and informational survey introduction, 2) male narrator and motivational survey introduction, 3) female narrator and informational survey introduction, and 4) female narrator and motivational survey introduction,male motivational, female informational, female motivational) which were then followed by a noncommunicable disease risk factor survey. this mobile phone survey was sent as an interactive voice response (ivr). in ivr surveys, participants use their touch tone key pad to answer pre-recorded questions. (i.e. if you are male, press 1; if you are female, press 2). this study was conducted in both bangladesh and uganda.

Eligibility criteria:
inclusion criteria: * access to a mobile phone * greater or equal to 18 years of age * in bangladesh, conversant in either english or bangla language. in uganda, conversant in either luo, luganda, runyakitara or english languages. exclusion criteria: * less than 18 years of age

Keywords: mobile phone surveys interactive voice response narration
trial of a new online programme for physical activity and healthy eating.

Conditions: Overweight/Obesity

Summary: many healthy lifestyle interventions have been developed to help people change their activity and diet, lose weight and thus reduce their risk of developing type 2 diabetes (t2dm) and cardiovascular disorders (cvd). however, these interventions often fail to engage their target audience, which undermines their effectiveness in changing behaviour and health outcomes. the purpose of this study is to investigate the effectiveness of a self-directed, website-based intervention to promote physical activity and healthy dietary behaviours. the intervention frames health information from a novel perspective, which our previous work has indicated can help to promote interest in the health information and improve attitudes, self-efficacy and motivation towards physical activity and healthy dietary behaviours. the intervention comprises a website of information resources and personal recording areas to set goals and monitor activity and diet, weekly emails and pedometers. in this trial we aim to see whether the intervention has any impact on people's physical activity and diet, as well as their risk of developing cvd and t2dm. the intervention will be compared with a control condition in which participants will be shown standard resources available on nhs websites. overweight/obese (bmi 25 - 39.5) males and females aged 35-74 years will be recruited from the community. the active intervention will last 6 weeks (during this period participants will receive weekly emails from the research team) and there will be a 6-week follow-up phase (in which participants will still have access to the website but contact from the research team). activity, diet, disease risk markers and psychological antecedents of behaviour will be assessed at baseline, post-intervention (6-weeks) and post follow-up (12- weeks).


Eligibility criteria:
inclusion criteria: * able to give informed consent to participate in the study. * male or female and aged between 35-74 years. * defined as overweight or obese, i.e. bmi\>25kg/m2. * able to travel to the university for assessment days. exclusion criteria: * individuals who are not fluent in the english language, and who do not have access to and do not regularly use the internet and an email account. * individuals diagnosed with coronary heart disease, chronic kidney disease, type 2 diabetes, stroke, heart failure, severe hypertension (bp\>180/110mmhg) and peripheral arterial disease. * bmi\>40kg/m2 (morbidly obese). * currently using weight loss drugs or other medication that can affect weight. * any reported recent (i.e. last 6 months) shift (\>5%) in body mass or large change in habitual lifestyle. * individuals unable to change their physical activity (e.g. through disability). * current (pre-baseline) or recent (i.e. last 2 months) participation in another research trial or lifestyle supportive intervention or referral. * pregnant

Keywords: physical activity diet health behavior
analyze the myelin-trap as diagnostic tool in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the objective of this project is to characterize the response trap positive patients with multiple sclerosis (ms) and to evaluate the sensitivity and specificity of the method in order to develop a second time as a diagnostic tool in this disease. we plan to analyze the response trap over a hundred patients with various clinical stages sep (relapsing, progressive forms) and compared to healthy controls,


Eligibility criteria:
inclusion criteria: * these criteria depend on the subgroup belongs to the patient. * signed consent * membership of a social security system exclusion criteria: * whatever the patient group or control: * processing immunosuppressive. * processing by a monoclonal antibody. * previous treatment with an immunosuppressant for a significant period of time (more than 6 months of oral treatment, more than 6 cycles of cyclophosphamide over 3 cures mitoxantrone). * carcinomatous pathology known evolving. * people under guardianship. * pregnant women. * patients not motivated to study. known patients with anemia (hemoglobin \<10g/100ml)

Keywords: multiple sclerosis trap trap-myéline
amiloride for resistant hypertension

Conditions: Hypertension; Type 2 Diabetes Mellitus; Microalbuminuria

Summary: to evaluate the antihypertensive effect of amiloride added to triple antihypertensive therapy in patients with resistant hypertension (rh) and type 2 diabetes mellitus (t2dm)

the primary objective of this study was to evaluate the antihypertensive effect of amiloride added to triple antihypertensive treatment in patients with resistant hypertension and type 2 diabetes mellitus in an open-labelled, non- controlled and non-randomized interventional study. the secondary objectives were to evaluate the additional effects of amiloride on: * urinary albumin excretion * blood pressure control, how many patients reached blood pressure control when amiloride was added to previous triple antihypertensive treatment. * plasminogen and plasmin excretion (enac activity) in the micro-and macroalbuminuric patients in the cohort. * urokinase plasminogen activator (upa) activity

Eligibility criteria:
inclusion criteria: * diagnosed with resistant hypertension (average daytime bp \>130and/or \>80 mmhg by ambulatory monitoring in spite of treatment with 3 antihypertensive drugs including a diuretic and an angiotensin coverting enzyme inhibitor (aeci) or angiotensin recpetor blocker (arbs) and a third optional, all in optimal dosages. * type 2 diabetes * prior participant in a randomized controlled trial with spironolactone, but after a wash-out periods of minimum two weeks (nct01062763) exclusion criteria: * office blood pressure (bp) \>180/110 mmhg * daytime average bp by ambulatory monitoring \> 170/85 mmhg * heart failure (nyha iii-iv) cardiac arrythmia hba1c \> 10% severe dyslipidemia known or with signs of secondary hypertension estimated glomerular filtration rate (egfr) \<50ml/min per 1.73 m2 prior intolerance to spironolactone or amiloride fertility without oral contraception pregnancy lactation

Keywords: antihypertensive therapy amiloride add-on resistant hypertension blood pressure control type 2 diabetes mellitus, microalbuminuria.
an open-label study of jzp-458 (rc-p) in patients with acute lymphoblastic leukemia (all)/lymphoblastic lymphoma (lbl)

Conditions: Acute Lymphoblastic Leukemia; Lymphoblastic Leukemia

Summary: this is an open-label, multicenter, dose confirmation, and pk study of jzp-458 in patients (of any age) with all/lbl who are hypersensitive to e. coli-derived asparaginases (allergic reaction or silent inactivation). this study is designed to assess the tolerability and efficacy of jzp-458 (only in patients who develop hypersensitivity to an e. coli-derived asparaginase), as measured by asparaginase activity.


Eligibility criteria:
inclusion criteria: 1. pediatric and adult patients with a diagnosis of all or lbl. 2. have had an allergic reaction to a long-acting e. coli-derived asparaginase or have silent inactivation. 3. have 1 or more courses of e. coli-derived asparaginase remaining in his/her treatment plan. 4. patients must have, in the opinion of the investigator, fully recovered from their prior allergic reaction to e. coli-derived asparaginase. exclusion criteria: 1. have previously received asparaginase erwinia chrysanthemi or jzp-458. 2. have relapsed all or lbl. 3. are concurrently receiving another investigational agent and/or treated with an investigational device at the same time as jzp-458 (within 48 hours) during course 1 of jzp-458. 4. have a history of ≥ grade 3 pancreatitis. 5. prior history of asparaginase-associated ≥ grade 3 hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy, excluding catheter-related thrombotic events.

Keywords: all lbl asparaginase leukemia childhood acute lymphoblastic leukemia
study evaluating the safety & efficacy of dvs-223 sr for relief of vasomotor symptoms associated with menopause

Conditions: Vasomotor Symptoms

Summary: the purpose of this study is to assess the efficacy and safety of 4 doses of desvenlafaxine-233 sustained release (dvs-233 sr) as compared to placebo for the treatment of moderate to severe vasomotor symptoms associated with menopause, as well as its influence on sleep parameters and other health outcomes indicators.


Eligibility criteria:
inclusion criteria: 1. generally healthy, postmenopausal women; at least 12 months of spontaneous amenorrhea or at least 6 months of spontaneous amenorrhea with serum fsh levels \> 40 miu/ml or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy). 2. minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week at screening: * moderate hot flush: warm sensation with sweating, does not disrupt activity. * severe hot flush: hot sensation with sweating, disrupts activity. 3. subjects must have body mass index (bmi) less than or equal to 40 using the nomograph for bmi. exclusion criteria: 1. hypersensitivity to venlafaxine (effexor or effexor xr). 2. use of oral estrogen-, progestin-, androgen-, or serm-containing drug products within 8 weeks prior to screening; use of transdermal hormone products within 8 weeks prior to screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to screening; use of intrauterine progestins within 8 weeks prior to screening; use of progestin implants or estrogen injectables within 3 months prior to screening; use of estrogen pellet or progestin injectables within 6 months prior to screening. 3. history of a seizure disorder other than a single childhood febrile seizure.
now thai haart study

Conditions: HIV; AIDS; Neurological Complications

Summary: after initiation of haart in peoples who living with hiv/aids in thailand by the year 2000, rapidly expanded haart access of national project has been promoted in 2004. free arvs (for cd4\<200cell/cu.mm. or in symptomatic hiv with cd4\<250 cell/cu.mm. )and cd4 monitoring has been available. the first-line regimen is d4t+3tc+nvp in mainly the first time (naive) patients. cd4 response ), rate of opportunistic infection, and neurological outcomes were measured. rate of arv change, adverse events,treatment failure, tb co-infection rate, percent changing to efv-based regimen or pi-based regimen were recorded. any adverse events including, sever rash, severe hepatitis, lipid abnormalities, severe anemia and other, common aes will be analysed.


Eligibility criteria:
inclusion criteria: * hiv/aids patients. * age \>15 years. * informed consent exclusion criteria: * not informed consent

Keywords: hiv aids neurological complications haart
study of cysteine hydrochloride for erythropoietic protoporphyria

Conditions: Erythropoietic Protoporphyria

Summary: objectives: i. determine the efficacy of cysteine hydrochloride in preventing or decreasing photosensitivity in patients with erythropoietic protoporphyria.

protocol outline: this is a randomized, double blind, placebo controlled, crossover study. patients are randomly assigned to 1 of 2 groups to receive cysteine hydrochloride orally twice daily, 2 capsules with breakfast and 2 with lunch. group 1 receives cysteine hydrochloride in drug ingestion period 1 followed by placebo in period 2. group 2 receives placebo in period 1 followed by cysteine hydrochloride in period 2. both groups ingest placebo for 1 week between the periods. each drug ingestion period lasts 8 weeks. follow up phone calls are made at the end of months 1 and 3. all patients schedule follow up visits at the end of each drug ingestion period.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- documented erythropoietic protoporphyria determination of elevated protoporphyrin within the past year experiencing photosensitivity --prior/concurrent therapy-- no concurrent use of betacarotene --patient characteristics-- other: not pregnant or nursing fertile female patients must use effective contraception while on study and for 3 weeks thereafter

Keywords: erythropoietic protoporphyria inborn errors of metabolism porphyria rare disease
clinicopathological analysis of endometrial carcinoma in the view of old and new international federation of gynecology and obestetrics (figo)

Conditions: Clinicopathological; Endometrial Carcinoma; Federation of Gynecology and Obestetrics

Summary: assess the percentage change in stage and risk stratification for patients with endometrial cancer when transitioning from the figo 2009 endometrial staging system to the updated figo 2023 endometrial staging system. investigate the prognostic impact of the figo 2023 endometrial staging system on patient survival. evaluate how the shift in stage classification between the figo 2009 and figo 2023 systems influences adjuvant management decisions for endometrial cancer.

endometrial cancer is the commonest gynecological cancer mostly affecting women in the post-menopausal age group . the average age of women diagnosed with endometrial cancer is 60. it's uncommon in women under the age of 45. the vast majority of endometrial cancers are carcinomas (usually adenocarcinomas). the five-year survival rate for endometrial adenocarcinoma following appropriate treatment is 80%. more than 70% of women diagnosed have federation of gynecology and obestetrics (figo) stage i cancer, which has the best prognosis. stage iii and especially stage iv cancers has a worse prognosis, but these are relatively rare, occurring in only 13% of cases. the median survival time for stage iii-iv endometrial cancer is nine to ten months. the figo 2023 staging system provides a refined framework for managing endometrial cancer, benefiting patient care and outcomes as the figo 2023 staging system for endometrial cancer offers several advantages over the previous figo 2009 system 1. improved prognostic prediction: the 2023 system predicts survival more accurately, validated by five studies and it adds granularity to prognostic assessment, identifying treatment-relevant subgroups of patients. 2. incorporation of molecular measures as the 2023 system integrates molecular parameters, reflecting their impact on prognosis (similar to breast cancer staging) 3. risk stratification: it incorporates risk stratification, aiding better prognosis definition and treatment decisions. 4. enhanced understanding of endometrial carcinomas: the 2023 system clarifies the diverse biological nature of endometrial cancers, allowing for better-adapted treatment.

Eligibility criteria:
inclusion criteria: - patients diagnosed with endometrial cancer (ec) who underwent surgical staging (total hysterectomy and bilateral salpingo-oophorectomy) between january 1, 2018, and december 31, 2022 with available medical records since diagnosis and at least follow up 2 years and received adjuvant treatment and available histopathological slides and blocks. exclusion criteria: - patients who received neoadjuvant chemotherapy, had recurrent endometrial cancer, had multiple cancers, lacked histopathological slides and formalin-fixed paraffin-embedded blocks or lacked medical records were excluded
safety study of olopatadine nasal spray

Conditions: Perennial Allergic Rhinitis

Summary: the purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.


Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of perennial allergic rhinitis who are 12 years and older exclusion criteria: * age 11 years and younger

Keywords: rhinitis perennial allergic rhinitis allergic rhinitis