Kornimate/medical-research-clean huggingface dataset:
mailed fit outreach to improve colon cancer screening in the safety-net system

Conditions: Colonic Neoplasms

Summary: uptake of colorectal cancer (crc) screening is suboptimal in the san francisco health network and access to care may be limited so novel models of health care delivery are warranted. the objective of this study is to examine whether a centralized panel management model with mailed fecal immunochemical test (fit) will be effective at increasing the uptake of crc screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses.

rationale: since uptake of colorectal cancer (crc) screening is suboptimal in the sf safety-net system and access to care may be limited, novel models of health care delivery are warranted. the overall hypothesis is that a centralized panel management model with mailed fecal immunochemical test (fit) will be effective at increasing the uptake of crc screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses. barriers to immunization of adults include missed opportunities during visits, limited access to providers, and provider and patient beliefs of efficacy. design: to rigorously examine the benefit of the centralized panel management to improve uptake of crc screening with mailed fit, the electronic health system will be used to identify eligible patients who are not up-to-date with crc screening. broadly, patients will be randomized 1:1 to usual care or intervention arm, stratified by clinic, gender, prior screening, and race to receive mailed fit kits + usual care versus usual care alone. the cost-effectiveness of no screening, usual care, and centralized management with mailed fit outreach will be compared using mathematical simulation models.

Eligibility criteria:
inclusion criteria: * asymptomatic men and women * 50 to 75 years of age exclusion criteria: * personal history of polyps requiring colonoscopic surveillance * homeless * severe co-morbidities limiting life expectancy e.g., advanced stage cancer
a clinical trial of ymc017 in hypertensive and hypercholesterolemic patients with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: this is a randomized, open-label, 2 groups, parallel design.

this study objective is to compare the safety and efficacy between fixed dose combination (duowell® tab) and free pill combination therapy of telmisartan and rosuvastatin in hypertensive and hypercholesterolemic patients with metabolic syndrome.

Eligibility criteria:
inclusion criteria: * aged between 19 and 79 years old at screening visit * subjects who have being used anti-hypertension drugs and lipid lowering agents over 4weeks before randomization. * subjects who have been diagnosed with metabolic syndrome according to following criteria definition of patients with metabolic syndrome: patients satisfy two of the following criteria at least * abdominal obesity: waist measurement \> 90 cm(male), \> 80 cm(female) * triglyceride(tg) ≥ 150 mg/dl( * high-density lipoprotein cholesterol(hdl-c) \< 40 mg/dl(male), \< 50 mg/dl (female) * fasting plasma glucose(fpg) ≥ 100 mg/dl or subject who has being used oral hypoglycemic agents * childbearing potential women have certainly negative of the pregnancy test at screening visit (visit 1), and agree to implement the effective contraception during the study period(including the medically non-pregnant state) * subjects who have signed after fully understanding the purpose, content, characteristics and risk of the investigational product and get explained enough. exclusion criteria: * subjects who taking anti-hypertension drugs more than three agent * subjects who have mean sitting systolic blood pressure(sisbp) \> 160 mmhg (excluded if appliable, one of the arms) * subjects who have blood pressure ≥ 140/90 mmhg with taking 2 or more anti-hypertension drugs (except if any of the arms) * subjects that low density lipoprotein-cholesterol(ldl-c) isn't properly controlled according to national cholesterol education program adults treatment panel (ncep atp) iii criteria * subjects who have triglyceride (tg) ≥ 400mg/dl * subjects who have a difference more than 20mmhg at the mean sitting diastolic blood pressure(sisbp) measured three times in both arms. * other exclusions applied
paclitaxel/carboplatin plus bevacizumab/erlotinib in the first line treatment of carcinoma of unknown primary site

Conditions: Neoplasm, Unknown Primary

Summary: we will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment of patients with carcinoma of unknown primary site. there is limited experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis pathways and/or the egfr pathway are effective strategies in at least a proportion.

all eligible patients will receive: * bevacizumab 15mg/kg iv infusion,day 1 * paclitaxel 175mg/m2, 1-3 hour iv infusion,day 1 * carboplatin auc 6.0 iv day 1 * erlotinib 150 mg by mouth daily the regimen will be repeated every 21 days for a total of 4 courses. patients will be initially evaluated for response after completing 2 courses (6 weeks) of treatment. patients with an objective tumor response or stable disease will continue treatment for another 2 courses. patients will be re-evaluated after 4 courses and those with objective tumor response or stable disease will stop chemotherapy with paclitaxel/carboplatin and continue treatment with bevacizumab/erlotinib until tumor progression is documented for a maximum of 12 months. during treatment with bevacizumab/erlotinib response will be evaluated every 12 weeks.

Eligibility criteria:
inclusion criteria: * biopsy proven metastatic carcinoma with the following light microscopic histologies: adenocarcinoma, poorly differentiated carcinoma(must have immunoperoxidase stains to rule out lymphoma, neuroendocrine carcinoma),or poorly differentiated squamous carcinoma. * ecog performance status 0-1 * no previous treatment with any systemic therapy * adequate kidney, liver and bone marrow function * be able to understand the nature of the study and give written informed consent exclusion criteria: * the following specific syndromes: * neuroendocrine carcinoma * women with adenocarcinoma isolated to axillary lymph nodes * women with adenocarcinoma isolated to peritoneal involvement * carcinoma involving only one site with resectable tumors at that site * squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes * uncontrolled brain metastases and all patients with meningeal involvement * women pregnant or lactating * clinically significant cardiovascular disease * history of myocardial infarction or stroke within 6 months * clinical history of hemoptysis or hematemesis * patients with peg tubes or g-tubes * proteinuria * history of bleeding diathesis or coagulopathy please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have. you can then decide if you wish to participate.

Keywords: neoplasm, unknown primary
a study to investigate the relative bioavailability of entrectinib capsule formulations f1 and f06 under fed conditions in healthy participants

Conditions: Healthy Volunteers

Summary: this study aims to investigate the relative bioavailability, safety, and tolerability of entrectinib capsule formulations f1 and f06 under fed conditions in healthy adult male and female participants.


Eligibility criteria:
inclusion criteria: * healthy in the opinion of the investigator. healthy is defined by the absence of evidence of any active disease or clinically significant medical condition based on a detailed medical history and examination * negative test results for hepatitis b, hepatitis c, and human immunodeficiency virus (hiv) * females must not be pregnant or breastfeeding, and females of childbearing potential will agree to use highly-effective contraception. females of childbearing potential must also agree to refrain from donating eggs during the treatment period and for 6 weeks after the final dose of study drug * males must agree to use contraception and to refrain from sperm donation from check-in (day -1 of period 1) to 90 days after the final dose of study drug exclusion criteria: * history of gastrointestinal surgery or other gastrointestinal disorder that might affect absorption of medicines from the gastrointestinal tract * presence of a clinically significant disease, illness, medical condition or disorder, or any other medical history determined by the investigator to be clinically significant and relevant. ongoing chronic disorders which are not considered clinically significant are permissible providing they are stable * clinically significant change in health status, as judged by the investigator, or any major illness within the 4 weeks before screening, or clinically significant acute infection or febrile illness within the 14 days before screening * participation in any other clinical study involving an investigational medicinal product (imp) or device within 30 days or 5 half-lives (if known), whichever is longer, before screening
stroke - 65 plus. continued active life.

Conditions: Self-management; Quality of Life

Summary: since august 2016, the researchers at a highly specialized neurorehabilitation hospital in a danish region with 1.2 inhabitants have in cooperation with health professionals from a specialized neurorehabilitation in a danish municipality with 336,000 inhabitants, worked through and is still working with an iterative process in the development of a novel self-management support intervention for elderly stroke individuals.the intervention is going to be implemented into the second phase- a randomized clinical controlled trial (rct) in the project named 'stroke - 65 plus. continued active life'.

background: elderly adults represent the majority of stroke cases worldwide. sequelae after a stroke causes the stroke individuals to live a more isolated life 5 years after the stroke. this makes the stroke individuals an especially vulnerable group of elderly people regarding social reintegration. reintegration into the community post-stroke depends highly on support from the family. however, the stroke individual's closest relatives are at risk of developing anxiety and depression. the aim of this study is to investigate the effect of a novel self-management intervention supporting older adults after stroke methods/design: randomized controlled observer-blind trial. more than sixty stroke survivors over 65 years will two weeks before leaving a rehabilitation hospital be randomized to either a group receiving conventional rehabilitation (control) or a novel self-management intervention addition to standard rehabilitation. during a period of 6 months the patients will be offered additional 6-8 sessions of self-management intervention of 45-60 minutes duration by a physiotherapist or an occupational therapist. study outcome measurements: stroke self-efficacy questionnaire, stroke specific quality of life scale and impact on participation and autonomy and activity by accelerometers will be evaluated at baseline, three and nine months post hospital treatment. patient, informal caregiver and therapist satisfaction will be with examined with questionnaires and interviews. discussion: self-management interventions are promising tools for rehabilitation of self-efficacy, quality of life as well as participation and autonomy. the introduction of novel self management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke, quality of life and burden on relatives. stroke 65+ trial will provide further evidence of self management strategies to clinicians, patients and health economists.

Eligibility criteria:
inclusion criteria: * stroke survivors with rehabilitation needs discharge from rehabilitation hospital to home exclusion criteria: * do not understand danish montreal cognitive assessment (moca) below 20

Keywords: self-management quality of life self-efficacy support stroke older adults
prolonged daily temozolomide for low-grade glioma

Conditions: Glioma; Astrocytoma; Oligodendroglioma

Summary: the purpose of this trial is to determine the effects (good and bad) temozolomide has on patients with low-grade glioma. it will also determine whether temozolomide is effective in preventing or delaying future tumor growth.

* treatment with temozolomide is based upon an 11-week cycle (7 weeks on the drug and 4 weeks off). patients will receive temozolomide once daily for 49 days, then have 28 days without taking temozolomide. * every two to four weeks a physical and neurological examination and blood work will be performed. a magnetic resonance imaging (mri) scan of the patient's brain will be done approximately every three months (before each cycle of treatment). * treatment may continue for a maximum of a year and a half based on 6 eleven-week cycles. the actual duration of therapy will depend upon the response to treatment and the development of side effects or toxicity.

Eligibility criteria:
inclusion criteria: * histological confirmation of a low-grade glioma (astrocytoma, oligodendroglioma, or mixed oligoastrocytoma) * measurable disease on mri * patients that have undergone recent resection for newly diagnosed or recurrent or progressive tumor are eligible if they have recovered from the effects of surgery. * patients with recurrent disease my have had one prior chemotherapy regimen * older than 18 years of age. * karnofsky performance status (kps) performance score of \> 70% * adequate hematologic, renal and liver functions, * life expectancy of greater than 12 weeks. * negative pregnancy test. exclusion criteria: * prior treatment with temozolomide * patients who are not neurologically stable * acute infection treated with intravenous antibiotics * non-malignant systemic disease * frequent vomiting, inability to swallow or a medical condition that could interfere with oral medication. * previous or concurrent malignancies at other sites, with the exception of surgically cured carcinoma in-situ of the cervix, and basal or squamous cell carcinoma of the skin. * hiv positive or aids-related illness * pregnant or nursing women * patients with allergy to decarbazine.

Keywords: low-grade glioma astrocytoma oligodendroglioma oligoastrocytoma temozolomide mixed oligoastrocytoma
dolutegravir/rilpivirine, antiretroviral efficacy study using real-world data in subjects with human immunodeficiency virus (hiv)-1

Conditions: HIV Infections

Summary: this was a prospective, non-interventional, single-arm, multi-center study aimed at gathering real-world data on juluca use in routine clinical care in germany, to supplement clinical trial data to further improve/optimize care in hiv positive participants in germany. approximately 250 virologically suppressed hiv positive participants on stable antiretroviral therapy (art) were included in the study at the discretion of treating physician. eligible participants were followed up for approximately 3 years and data was collected during routine clinical care.


Eligibility criteria:
inclusion criteria: * greated than or equal to (\>=)18 years of age. * documented hiv-1 infection. * virologically suppressed (hiv-1 ribonucleic acid \[rna\] less than \[\<\] 50 copies \[c\]/ml for at least 6 months) * prescription for juluca was issued independently from entering this study. * ability to understand informed consent form and other relevant study documents exclusion criteria: * any contraindication according to juluca smpc. * documented viral load greater than (\>) 50 c/ml at any time point within 6 months prior to inclusion into this study. * history of treatment failure. * known or suspected substitutions associated with resistance to any non-nucleoside reverse-transcriptase inhibitors (nnrti) or integrase strand transfer inhibitor (insti). * any art for the treatment of hiv-1 in addition to juluca. * hepatitis b virus (hbv)-co-infection. * current participation in the ongoing non-interventional study triumph (study number: 202033) or any interventional clinical trial irrespective of indication. * previous participation in clinical trials involving juluca.

Keywords: 2 drug regimen juluca rilpivirine dolutegravir antiretroviral one pill regimen
lipid profile as predictor of adverse maternal and neonatal outcomes: a pilot study

Conditions: Hyperlipidemia; Pregnancy

Summary: the purpose of this study is to ascertain lipid profiles during pregnancy, specifically during the 24-28 week gestation and again near term at 36 weeks gestation. the research team are investigating whether lipid profiles can predict adverse maternal and neonatal outcomes.

the purpose of this research is to investigate whether lipids profiles during pregnancy impact lga and other adverse outcomes in pregnancy. participants will have blood drawn twice; the first blood work is a fasting blood draw (separate blood draw) on the same day but preceding the standard glucose test. the second blood draw is drawn at the time of routine clinical care (third trimester blood work). patients will be approached at the time of the anatomy ultrasound for participation. if they consent to participate they will have a fasting lipid panel drawn at the time of their 24-28w gct and again at the time of their 36w third trimester labs. patients will receive a reminder call prior to scheduled 24-28 week appointment for fasting instructions.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * ages 18-45 * presentation to prenatal care by the 2nd trimester * prenatal care at mount sinai hospital * anticipated delivery at mount sinai hospital exclusion criteria: * multiple gestations * preexisting hyperlipidemia * preexisting diabetes * delayed presentation to prenatal care after the 2nd trimester 5. prenatal care or delivery outside of mount sinai health system
evaluation of objective pain measurement device

Conditions: Pain; Analgesia; Labor Pain

Summary: this study will attempt to objectively measure pain with an experimental device. the investigators will apply the device to measure patients "pain" due to uterine contractions during routine clinical care to correlate patients verbal pain ratings and analgesia requirements to that measured by the device. a brain oxygenation device, edwards foresight, will be used to concurrently to monitor brain oxygenation and hemodynamics, so the relationship between the cerevu ropa device objective measure of pain and brain oxygenation/hemodynamic changes and patient-reported pain can be determined.

despite all the progress in our understanding of the basic mechanisms of pain, the gold standard for measuring pain is still a subjective verbal numeric rating scale rating (0-10) obtained from the individual reporting pain. this method is not objective and cannot be used in all patient populations. this study will attempt to objectively measure pain in laboring mothers with a pain measurement device. the investigators aim to 1) see if the pain measurement device (cerevu ropa) is capable of reflecting different levels of pain ratings in patients in labor having uterine contractions and then changes in pain after receiving different neuraxial techniques for labor pain and to 2) additionally determine the relationship between the cerevu ropa device, brain oxygenation/hemodynamic changes and patient-reported pain scores.

Eligibility criteria:
inclusion criteria: * age 18-50 * asa 1 or 3 +/-e * patient requesting epidural labor analgesia * good toco tracing (clearly showing contractions at least every 5 minutes) * pain score greater than or equal to 3 out of 10 with contractions exclusion criteria: * history of chronic pain * history of chronic opioid use * bmi \> 45 * allergy to sensor adhesive material, local anesthetic or opioids * contraindication to neuraxial block * patient on magnesium infusion * inability to give informed consent or understand english
comitial prophylaxis in neurosurgery in patients who have undergone intracranial surgery programmed supratentorial surgery (exeresis or biopsy) between 2019 and 2022

Conditions: Anti-epileptic Prophylaxis in Intracranial Neurosurgery

Summary: justification anti-epileptic prophylaxis has long been a systematic practice for supra-tentorial intracranial surgeries. since 2021, european guidelines no longer recommend this prophylaxis and practices have evolved. we therefore propose to compare epileptic seizure's occurrence in the first postoperative month between two groups of neurosurgical patients.the first group consists of patients treated between january 2019 and late 2020 who were given systematic prophylaxis. patients from the second group were treated between 2021 and 2022 and did not receive any prophylaxis. the secondary objective will consist in identifying the number of patients placed on prophylaxis, the length of prophylaxis, treatment's side effects (depression, elevated liver enzymes...), and comparing patients' neurological outcome at 3 and 6 months after surgical procedures.


Eligibility criteria:
inclusion criteria: * adults over 18 years old * expressed non-opposition * patient who underwent supratentorial intracranial surgery (either resection or biopsy) at brest university hospital from january 01, 2019 to september 01, 2022. exclusion criteria: * refusal to participate * patient under legal protection

Keywords: anti-epileptic prophylaxis intracranial neurosurgery epileptic seizures
dexmedetomidine to prevent agitation after free flap surgery

Conditions: Agitation; Delirium

Summary: reconstruction using microvascular free tissue flap has been an important management in patients with maxillofacial tumor. it is often characterised as long operation time, more traumatic and require restriction of patient's head movement postoperatively in order to prevent disruption of microvascular anastomosis. agitation and delirium are common in patients with free flap surgery, which may lead to serious consequences such as self extubation, injury or even failure of the flap. dexmedetomidine is a sedative and co-analgesic drug with high specificity for α2-adrenoceptor. it is widely used in icu sedation in general hospital. however its use after free flap surgery is not well documented. furthermore the effect of dexmedetomidine on preventing delirium has not been proved. the investigators hypothesized that the use of dexmedetomidine would reduce emergence agitation and prevent delirium in patients after free flap surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing selected maxillofacial surgery with free flap reconstruction * american society of anesthesiologist(asa) classification i and ii exclusion criteria: * bradycardia (\< 50 bpm) * severe heart block * low blood pressure(sbp\<80mmhg) * known allergy to alpha 2 agonists

Keywords: agitation delirium dexmedetomidine head and neck surgery microvascular free tissue transfer flap