Kornimate/medical-research-clean huggingface dataset:
rivet - retrospective cohort study on the risk of venous thromboembolism

Conditions: Venous Thromboembolism

Summary: the risk of venous thromboembolism (vte) associated with the use of chlormadinone acetate (cma) compared to the gold-standard progestin levonorgestrel (lng) as component of combined oral contraceptives (coc) is currently unknown. the pharmacovigilance risk assessment committee (prac) of the european medicines agency (ema) recommended a pooled analysis of four prospective cohort studies carried out by the berlin center for epidemiology and health research (zeg berlin) in order to clarify whether cma-containing cocs carry a different vte risk compared to lng-containing cocs.

this study is designed as a retrospective cohort study. zeg berlin conducted several large prospective cohort studies on the risk of vte associated with the use of hormonal contraceptives. four of these studies included a substantial number of women using cma/ee or lng/ee-containing cocs. for this study, the data on cma/ee and lng/ee from the following four prospective cohort studies are combined: 1) euras-oc/lass 2) inas-oc 3) inas-score and 4) inas-focus. participants will be identified retrospectively from a pooled dataset which comprises four large, controlled, prospective, non-interventional active surveillance studies that focused on the risk of vte associated with the use of combined oral contraceptives. all data were prospectively collected by zeg berlin and follow the euras/inas study design. inclusion and exclusion criteria, the method of patient recruitment and follow-up as well as research methods were similar across studies. the euras-oc/lass study was conducted in europe only; the other three studies are transatlantic studies that include subjects from both europe and the united states of america. this analysis is specifically designed to assess the risk of vte associated with the use of cocs containing cma/ee compared to lng/ee.

Eligibility criteria:
inclusion: female, aged 15 to 49 years, participation in one of the 4 observational studies conducted between 2000 and 2019 (lass/euras-oc, inas-oc, inas-score, inas-focus), coc new user (starters, switchers, and re-starters), applied cocs: cma/ee or lng/ee. exclusion of women with a personal history of vte.
evaluation of respiratory motion-corrected cone-beam ct in radiation treatment of thoracic and abdominal cancers

Conditions: Gastric Cancer; Lung Cancer

Summary: tumors must be seen clearly on ct scan to be radiated completely and safely. breathing causes tumors to move. if the tumor moves during breathing, it can look blurred on the ct scan. this makes it difficult to see on ct scan. the investigators wish to investigate whether a new computer method makes tumors less blurry and easier to see on ct scan. cone-beam ct is a type of ct scanner attached to the radiation treatment machine that produces 3d images of the patient. since your tumor can move because of your normal breathing, it is often blurry and difficult to see accurately in a standard cone-beam ct scan. the investigators intend to use a computer method which processes the cone-beam ct data in a way that reduces the blurring and makes the tumor easier to see.


Eligibility criteria:
inclusion criteria: * patients must have histologic proof of a thoracic or abdominal malignancy, confirmed at mskcc and suitable for radiation therapy, in order to be eligible for this study. thoracic malignancies (study group 1) include those in lung and gastro-esophageal junction. abdominal malignancies (study group 2) include those in liver and pancreas. patients having both thoracic and abdominal malignancies will be placed in only one of the study groups, because the limited field-of-view of the cbct precludes imaging of both malignancies in the same scan. patients must be older than 18 years of age * at least part of the tumor must be visible as observed in a diagnostic or planning ct. the tumor must exhibit at least 5 mm motion from respiration as observed in the respiration-correlated ct (rcct) at simulation. the rcct scan must be interpretable and not exhibit excessive motion artifacts caused by irregular patient breathing. * patients must have karnofsky performance status ≥ 70% exclusion criteria: * mesothelioma and other tumors of the pleura * pregnant women * allergic to iodine or intravenous contrast agent (applies only to patients with a pancreas or liver malignancy) * renal impairment due to the use of a contrast agent * patients with pacemakers and defibrillators

Keywords: gastro-esophageal junction lung abdominal cone-beam ct (cbct) 10-146
effects of covid-19 convalescent plasma (ccp) on coronavirus-associated complications in hospitalized patients

Conditions: COVID-19; Sars-CoV2

Summary: the purpose of this study assess the efficacy and safety of anti-sars-cov-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.

a total of 50 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent fresh frozen plasma (frozen within 8 hours of collection) of pf24 (frozen within 24 hours) from blood donors who have recovered from covid-19 containing antibodies to sars-cov-2 or control (standard fresh frozen plasma collected prior to 12/1/2019 or with documented negative sars-cov-2 antibody). should additional anti-covid agents (anti-viral and/or anti-inflammatory) become available for use as standard of care during implementation, the sample size will be recalculated and increased to account for the estimated impact that these agents may have on the reducing the progression to the primary endpoint of severe hypoxemia.

Eligibility criteria:
inclusion criteria for enrollment: 1. patients ≥18 years of age 2. hospitalized with covid-19 3. enrolled within 72 hours of hospitalization or within day 14 from first signs of illness 4. pulmonary infiltrates on chest imaging 5. oxygenation of \<95% on room air 6. laboratory confirmed covid-19 exclusion criteria 1. contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure 2. baseline requirement for oxygen supplementation prior to covid-19 infection or use of positive pressure therapy for sleep disordered breathing 3. currently experiencing severe hypoxemic failure, as defined in study endpoints 4. prior receipt of plasma products, ivig, or hyperimmune globulin within past 3 months 5. not currently enrolled another interventional clinical trial of covid-19 treatment. note: if taking medications with potential anti-covid activity for the purpose of covid-19 treatment that do not yet have data to support efficacy, such as il-6 antagonists, these medications must be stopped prior to enrollment. receipt of current standard of care covid-19 treatment, including remdesivir and dexamethasone is permitted and should be recorded as a concomitant medication. note: pregnancy is not exclusionary but will merit additional discussion of risks \& benefits in the context of ongoing pregnancy

Keywords: covid-19 sars-cov2 convalescent plasma
a study using us medical and pharmacy claim records to compare the resource use, cost, and outcomes of people with copd who take either tiotropium + olodaterol or fluticasone + umeclidinium + vilanterol

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to estimate disease-related and all-cause burden and clinical outcomes of interest following initiation of chronic obstructive lung disease (copd) maintenance therapy with tiotropium bromide/olodaterol (tio/olo) or fluticasone furoate/umeclidinium/vilanterol (ff/umec/vi).


Eligibility criteria:
inclusion criteria: * ≥30 consecutive days with tiotropium bromide/olodaterol (tio/olo) or fluticasone furoate/umeclidinium/vilanterol (ff/umec/vi) initiated during the patient identification period of 01 june 2015 to 30 november 2019. the index date will be the date of the tio/olo or ff/umec/vi pharmacy claim that starts the ≥30 consecutive days with the medication. * \>1 facility claim with a diagnosis of chronic obstructive lung disease (copd) in the primary position or ≥2 professional claims with a diagnosis code for copd in any position on separate dates of service during the study period * ≥40 years of age as of the year of the index date * continuous enrollment with medical and pharmacy coverage for 12 months prior to and including the index date (baseline period) * continuous enrollment with medical and pharmacy coverage for ≥30 days following the index date and without discontinuation of the index medication or switch to a non-index regimen (follow-up period); discontinuation and switch as defined in the protocol. exclusion criteria: * ≥2 medical claims with a diagnosis code for asthma, cystic fibrosis, lung cancer, or interstitial lung disease in any position on separate dates of service during the baseline period * pharmacy claims for both tio/olo and ff/umec/vi on the index date * a pharmacy claim for any non-index copd maintenance medication on the index date, defined as: long-acting muscarinic antagonists (lama) monotherapy; long-acting beta2 agonists (laba) monotherapy; inhaled corticosteroids (ics) monotherapy; fixed-dose combination (fdc) ics/laba, or fdc lama/laba * free or fixed dose lama+laba maintenance therapy defined as ≥7 consecutive days of overlapping days' supply with a lama and laba during a 6-month pre-index period, excluding the index date -- flags will be created to identify patients excluded for baseline lama/laba use overall and specifically for each fdc lama/laba medication * free or fixed dose triple therapy (tt) defined as ≥7 consecutive days of overlapping days' supply with an ics, laba, and lama during a 6-month pre-index period, excluding the index date * ≥1 medical claim with a procedure code for lung volume reduction during the study period * unknown age, gender, or business line, or unknown/other geographic region
the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy

Conditions: Prostatic Neoplasms; Frailty; Blood Biological Indicators; Quality of Life; Survival

Summary: the goal of this observational study is to evaluate the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy. the main questions it aims to answer are: 1. evaluate the impact of frailty on the blood biological indicators, quality of life and survival of patients with radical prostatectomy, specifically. 2. describe the longitudinal changes in the quality of life of patients with radical prostatectomy. participants will be divided into frail group or non-frail group based on frailty assessment. researchers will compare the two groups to see the impact of frailty on the blood biological indicators, quality of life and survival.


Eligibility criteria:
inclusion criteria: 1. diagnosed with prostate cancer (be diagnosed by relevant imaging examinations or pathology); 2. radical prostatectomy is planned; 3. voluntarily sign the informed consent form. exclusion criteria: 1. diagnosed with other malignant tumors at the same time; 2. patients with acute infection.
role of cvvh in patients with acute paraquat poisoning

Conditions: Poisoning by Paraquat With Undetermined Intent

Summary: paraquat poisoning is characterized by multiple organ failure and pulmonary fibrosis with respiratory failure. accumulating evidence suggested that continuous venovenous hemofiltration (cvvh) had a beneficial role in the treatment of multiple organ dysfunction. the investigators hypothesized that cvvh might restore multiple organ function and reduce the high mortality rate of paraquat poisoning. to confirm it, an prospective clinical study would be carried out.

paraquat (1,1 '-dimethyl-4,4'-bipyridylium dichloride) is widely used as a herbicide. accidental or intentional ingestion of paraquat is common in many developing countries such as china, sri lanka and korea because of easy access. the high mortality rate of paraquat is due to its high toxicity and the lack of effective treatments. thus, the paraquat poisoning becomes one of major medical problem in the developing countries. paraquat poisoning is also one of major causes of death among young patients with acute poisoning in china. it is characterized by multiple organ failure and pulmonary fibrosis with respiratory failure. a growing body of evidence suggested that continuous venovenous hemofiltration (cvvh) had a great beneficial role in the treatment of multiple organ dysfunctions. we hypothesized that cvvh might reduce the high mortality rate of paraquat poisoning via restoring the multiorgan function, such as acute hepatic lesion, acute kidney injury, acute lung injury and acute pancreatic injury. we expect to enroll 100 patients from our hospital within 1 week after oral intake of paraquat. all patients were divided into group 1 and group 2. group 1 were treated with a standardized therapeutic regimen including stomach lavage, emergency haemoperfusion and drugs. group 2 were accepted with standardized treatment plus cvvh. the aim of this prospective clinical study was to evaluate the safety and efficacy of cvvh for the treatment of patients with paraquat poisoning. the survival rate, clinical manifestations and clinical parameters between these two groups were compared.

Eligibility criteria:
inclusion criteria: * all patients recruited in this study should meet the requirements as follows: 1. history of exposure to paraquat 2. concentration in urine or plasma from all patients who arrived at our hospital within 1 week of paraquat ingestion was more than 0.1 mg/l. 3. patients with a light blue, navy blue or dark blue color in urine dithionite tests within 1 week of pq ingestion, were classified as having pq intoxication and were included in this study. 4. patients with acute organ dysfunction such as acute kidney injury, hepatic injury or pancreatic injury. exclusion criteria: patients who had colorless urine pq tests, who arrived at any hospital more than 24 h after intoxication, who had not orally ingested pq or any other drug poisonings, who were younger than 14 years or older than 70 years, or who had been included in any previous control trials were excluded.

Keywords: acute paraquat poisoning hemoperfusion continuous blood purification
whack-a-mole: testing an intervention to increase melanoma identification

Conditions: Diagnoses Disease

Summary: the purpose of this study is to evaluate an interactive game designed to increase people's ability to identify cancerous moles.


Eligibility criteria:
inclusion criteria: * resident of u.s. * at least 18 years old * capable of reading english * member of panel assembled by survey provider exclusion criteria: * individuals under 18 years old

Keywords: melanoma identification
effect of apical negative pressure irrigation system at cleaning lateral canals and reduction of periapical lesions after endodontic therapy

Conditions: Root Canal Infection

Summary: the aim of the present study is to assess with pa x-rays and cbct scans the volumetric changes in periapical radiolucencies in endodontically treated teeth 1 year after endodontic treatment and evaluate how well the lateral canals are filled after irrigation with the new generation of negative irrigation pressure unit with and without the ultrasonic irrigation.

this is a single center, prospective clinical study conducted in patients who present for routine endodontic therapy. the study has been reviewed and approved by the institutional review board (ethics committee) aspire irb located at santee, ca. the clinical investigator will treat patients who present with radiographic evidence of periapical pathology and will randomize the subjects to either negative pressure irrigation system treatment (endovac pure) with ultrasonic irrigation or negative pressure irrigation system treatment (endovac pure) without ultrasonic irrigation. all other aspects of the treatment (access, instrumentation and obturation will be according to clinicians conventional clinical judgment. subjects will have a pre-treatment pa x-ray and cbct scan before treatment, a pa x-ray at six months and a cbct scan at one year post-treatment.

Eligibility criteria:
inclusion criteria: * demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * aged at least 18 years. * understands and is willing, able and likely to comply with all study procedures and restrictions. * good general and mental health in the opinion of the investigator or medically qualified designee; * no clinically significant and relevant abnormalities of medical history or oral examination; * absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements. * single or multi rooted-canal teeth diagnosed with pulp necrosis and symptomatic/ asymptomatic apical periodontitis as tested with routine diagnostics. * radiographic evidence of periapical lesion. exclusion criteria: * women who are known to be pregnant or who are intending to become pregnant over the duration of the study. * women who are breast-feeding. * pre-existing oral irritations. b) recent (within 30 days) gingival/oral surgery. c) any clinically significant or relevant oral abnormality. * known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * any subject requiring re-treatment.

Keywords: root canal treatment
a safety study of sacubitril/valsartan in japanese pediatric patients with heart failure due to systemic left ventricle systolic dysfunction who have completed clcz696b2319e1 study

Conditions: Heart Failure

Summary: the purpose of this open-label study was to collect additional safety information of sacubitril/valsartan and to provide post-trial access to sacubitril/valsartan for the eligible japanese patients who completed clcz696b2319e1(nct03785405) study until marketed product of pediatric formulation, film-coated granules in capsule, is available in japan.

this trial (clcz696b2319e2) was a multicenter, open-label extension study for japanese patients who have successfully completed the clcz696b2319e1 study. only japanese patients who successfully completed clcz696b2319e1 study and fulfilled protocol requirements were eligible to participate in this study. the first visit (visit day1) was the same day as the end of study visit of clcz696b2319e1 study.

Eligibility criteria:
inclusion criteria: * signed informed consent * \<18 years of age (at the time of signing informed consent) * completed clcz696b2319e1 study and safely enrolled exclusion criteria: * permanently discontinued the study treatment during clcz696b2319e1 study * renal vascular hypertension (including renal artery stenosis) * history of angioedema * having parents or legal guardians who do not give consent or allow the child to give assent, or inability of patient or the parents/legal guardians to follow instructions or comply with follow-up procedures * any medical condition(s) that may put the patient at risk in the investigator's opinion or that the investigator deems unsuitable for the study

Keywords: sacubitril/valsartan post-trial access pediatric heart failure
al18f-her2-bch pet in breast patients treated with neoadjuvant therapy

Conditions: Breast Cancer

Summary: to use the molecular pet radionuclide (f-18) labelled her2 affibody to evaluate the predictive and prognostic value in breast patients treated with neoadjuvant therapy


Eligibility criteria:
inclusion criteria: 1. aged ≥18 years old; ecog 0 or 1; 2. patients with newly diagnosis her2 positive or suspicious positive tumors; 3. receives neoadjuvant therapy 4. has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions; 5. life expectancy \> 3 months - exclusion criteria: 1. significant hepatic or renal dysfunction; 2. is pregnant or ready to pregnant; 3. cannot keep their states for half an hour; 4. refused to join the clinical research; 5. suffering from claustrophobia or other mental disorders; 6. any other situation that researchers considered it unsuitable to participate in the trial.

Keywords: breast cancer pet/ct neoadjuvant therapy her2 expression
renal resistive index in early detection of postoperative acute kidney injury

Conditions: Renal Insufficiency, Acute; Cardiac Surgery Associated - Acute Kidney Injury

Summary: the primary aim of our study was to investigate the role of renal doppler ultrasonography (usg) and preoperative/postoperative renal resistive index (rri) in the early prediction of aki. our secondary aim is to evaluate perioperative parameters that may cause aki, to determine the duration of intensive care unit (icu)/hospitalization and 30-day mortality.

our prospective, observational, cross-sectional study included patients with elective cardiac surgery under general anesthesia with prolonged crp (\>70 min) and aortic cross-clamp (acc) (\>60 min), \>18 years of age, without preoperative acute/chronic renal failure, and with preoperative/postoperative rri measurements. demographic data, comorbidities, medications, preoperative ejection fraction, admission hematocrit (hct) and baseline serum creatinine (scr), type of operation, and preoperative rri were recorded. intraoperative operation and cpb/acc duration, blood product transfusion, urine output, amount of bleeding, fluid balance, use of vasopressor/inotropic agents and diuretics, and complications were recorded. rri was measured by the same radiologist in the first postoperative hour. urine output and fluid balance, vasopressor/inotropic agent requirement, diuretic use, skr, hct level and blood product transfusion were recorded for 3 days postoperatively. according to kdigo guidelines, patients who did not develop cci-aki were divided into 2 groups as group 1 (n:64) and patients who developed cci-aki were divided into group 2 (n:26). in group 2, renal failure stage, duration (acute/chronic) and rrt were recorded. icu and hospital length of stay, postoperative complications and 30-day mortality were recorded.

Eligibility criteria:
inclusion criteria: * elective cardiac surgeries under general anesthesia with prolonged cpb (\>70 min) and aortic cross clemp (\>60 min) time * \>18 years of age, without preoperative acute or chronic renal failure * with preoperative and postoperative rri measurements exclusion criteria: * patients with known renal insufficiency, * patients with acute renal failure in the last 3 months * emergency surgeries, * patients with arrhythmia end-stage renal disease and renal transplant * patients patients with short duration of cpb (\<70 min) and ack (\<60 min) * failed doppler ultrasonography imaging

Keywords: acute kidney injury early detection renal artery doppler ultrasonography cardiopulmonary bypass