Kornimate/medical-research-clean huggingface dataset:
conventional and experimental chemotherapy with allogeneic transplant in young patients with acute myeloid leukaemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is evaluate patients with acute myeloid leukemia (\<=66 years), treated with conventional and experimental chemotherapy following allogeneic transplantation. this patients have been enrolled from 2000 to 2011 at the division of hematology, molinette university hospital. the purpose of data collection is to assess, with retrospective analysis, the clinical outcome divided by risk class and evaluated in patients who achieve complete remission after induction therapy and consolidation.


Eligibility criteria:
patients with acute myeloid leukemia (\<=66 years), treated with conventional and experimental chemotherapy following allogeneic transplantation. this patients have been enrolled from 2000 to 2011 at the division of hematology, molinette university hospital.
a study of baricitinib (ly3009104) in adult and pediatric japanese participants with nns/candle, savi, and ags

Conditions: Nakajo-Nishimura Syndrome; Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature Syndrome; STING-Associated Vasculopathy With Onset in Infancy; Aicardi Goutieres Syndrome

Summary: the main purpose of this study is to evaluate the efficacy and safety of baricitinib in adult and pediatric japanese participants with nakajo-nishimura syndrome/chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature (nns/candle), sting-associated vasculopathy with onset during infancy (savi), and aicardi-goutières syndrome (ags).


Eligibility criteria:
inclusion criteria: * have systemic signs and symptoms of inflammation as manifested nns/candle, savi, ags * have been diagnosed with genetic diagnosis * men must agree to use a reliable method of birth control during the study * women not of child-bearing potential or nonbreastfeeding * women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment * nns/candle and savi patients who are ≥17.5 months of age * ags patients who are ≥6 months of age * are ≥ 5kg in body weight exclusion criteria: * have received immunosuppressive biologic agent/monoclonal antibody/oral jak inhibitor/oat3 inhibitor and cannot discontinue prior to investigational product initiation. note: a washout period is required to each drug. * have diagnosis of current active tuberculosis (tb) or, latent tb who did not receive appropriate treatment. * have had a serious infection within 12 weeks prior to screening. * have a history of lymphoproliferative disease * have any history of venous thromboembolic event (vte) (deep vein thrombosis \[dvt\]/pulmonary embolism \[pe\]) prior to screening. * have had any major surgery within 8 weeks prior to screening. * have previously been enrolled in any other study investigating baricitinib.

Keywords: nakajo-nishimura syndrome candle savi ags
preemptive tips for variceal bleeding in cirrhotic patients with occlusive portal vein thrombosis

Conditions: Portal Hypertension; Portal Vein Thrombosis; Esophageal Varix Bleeding; Portosystemic Shunt

Summary: portal vein thrombosis (pvt) can lead to a further increase in portal venous pressure and increase the risk of rebleeding. whether patients with acute esophagogastric variceal bleeding with occlusive pvt benefit from preemptive tips is still controversial. the present study is directed at comparing the outcome of patients with acute variceal bleeding with occlusive pvt treated by standard therapy (vasoactive drugs + endoscopic variceal ligation) with or without preemptive tips (performed during the first 1-3 days after endoscopic procedure). the primary outcome is survival free of variceal rebleeding at 6 weeks from inclusion.

portal vein thrombosis (pvt) is a common complication in patients with cirrhosis, and the cumulative incidence of pvt is 4.6%, 8.2%, and 10.7% at 1 year, 3 years, and 5 years, respectively. pvt can lead to a further increase in portal venous pressure and increase the risk of rebleeding. according to baveno vii, pvt can be classified according to the degree of occlusion of the portal trunk as complete occlusion (no continuous luminal structure), partial occlusion (≥50% thrombus obstruction of the lumen), mild occlusion (\<50% thrombus obstruction of the lumen), or spongiotic degeneration (a large number of collateral vessels of the portal vein, with no visualization of the main portal vein). the results of a recent observational study suggested that patients with severe pvt with ≥50% thrombotic luminal obstruction had higher 6-week rebleeding rates (8.8% vs. 3.8%) and 1-year rebleeding rates (29.4% vs. 21.4%) after acute variceal bleeding. our previous clinical study showed that patients with cirrhotic pvt treated with tips had lower rebleeding rates and significantly higher rates of portal vein recanalization, and it was inferred that patients with acute esophagogastric variceal bleeding with severe pvt might benefit from preemptive tips. therefore, we propose to conduct a multicentre randomized controlled trial to enroll patients with acute esophagogastric variceal bleeding with occlusive pvt to compare the preemptive tips with the standardized therapy. the outcomes are rates of mortality, rebleeding, and complications.

Eligibility criteria:
inclusion criteria: * cirrhosis (diagnosed by imaging, laboratory tests, clinical symptoms, or liver biopsy); * admission due to acute bleeding from esophagogastric varices; * thrombus in the main trunk of the portal vein occupying ≥50% of the lumen. exclusion criteria: * prior treatment with tips or surgical shunt; * presence of contraindications to endoscopic treatment, carvedilol, or tips; * presence of hepatocellular carcinoma exceeding milan criteria; * presence of other systemic malignant tumors with expected survival time not exceeding 6 months; * presence of uncontrollable infection or sepsis; * presence of cardiac, pulmonary, or renal failure; * pregnant or lactating women; * refusal to sign the informed consent form.
improving autism screening with brain-related mirna

Conditions: Autism Spectrum Disorder; Developmental Delay

Summary: the goal of this project is to identify specific mirnas that are increased or decreased in the saliva of children with developmental delay and are useful for screening toddlers for asd. such a screening tool would improve the specificity of diagnosis, streamline referrals to developmental specialists, and expedite the arrangement of early intervention services.

the central aim of this project is to characterize the expression of exosomal microrna (mirna) in children with autism spectrum disorder (asd). currently, the cdc estimates the prevalence of asd in u.s. children to be 1 in 68. yet, the biological causes, diagnosis, and treatment of this disease remain ambiguous. growing evidence implicates a genetic role in asd. mirnas regulate genetic expression and are altered in lymphocytes, neurons and serum of patients with asd. recent studies of mirnas have shown that they can be packaged into exosomal vessels and extruded from neurons as extracellular signaling tools. this knowledge provides a novel approach for examining the genetic regulation of the central nervous system. we propose to measure the expression of extracellular mirna in children with asd. expression levels of mirna from blood and saliva will be compared between children with autism and normally developing controls. the goal of this study will be to identify genetic regulatory mechanisms involved in asd and provide potential biomarkers for diagnostic screening. the primary endpoints of this study are as follows: 1. characterization of brain-related mirna in the saliva of children with asd and typically developing control children between the ages of two and five years. 2. identification of sets of mirnas in saliva and plasma that are predictive of both asd diagnosis and severity of asd symptoms. this aim will enroll asd and control children age 12-24 months (inclusive). secondary endpoints include the identification of mirna expression patterns that correlate with asd symptom severity measured with standardized neuropsychologic testing and to characterize parental knowledge and attitudes towards epigenetic testing in the context of asd..

Eligibility criteria:
inclusion criteria: * • age at enrollment: 18 months and 6 years (inclusive) * control group documented negative asd screening on m-chat-r * asd group: established dsm-5 diagnosis * parent/guardian must be fluent in written and spoken english (required to complete study specific questionnaires etc) exclusion criteria: for autistic subjects study exclusion criteria will include: • autistic subjects with known syndromic autism (attributed to a known genetic mutation) control subjects only exclusion criteria will include: • a diagnosis of autism for both groups: wards of the state, active periodontal infection, active upper respiratory infection
randomized controlled trial of mri target biopsy: transrectal vs. transperineal

Conditions: Prostate Cancer

Summary: this prospective study of comparing between transrectal and transperineal prostate mri targeted biopsy to provide evidence for clinicians to select the appropriate biopsy approach under different conditions.

this prospective study of comparing transperineal (tp) prostate mri targeted biopsy with transrectal (tr) prostate mri targeted biopsy was aimed to provide evidence for clinicians to select the appropriate biopsy approach under different conditions. tp (n = 75) and tr (n = 75) will be performed randomly for 150 patients who are suspicious of prostate cancer (pca). the cancer detection rate (cdr), complication rate, visual analog scale (vas) score, most painful procedure, number of repeated biopsy and additional anesthesia, and operating time (starting from lying down on the operating table to getting up) will be recorded.

Eligibility criteria:
inclusion criteria: * prostate-specific antigen \> 4ng/ml * palpation is positive exclusion criteria: * older than 80y * prostate-specific antigen \> 100 ng/ml
ravulizumab treatment outcomes in patients with generalized myasthenia gravis

Conditions: Myasthenia Gravis, Generalized

Summary: the polish multicentre observational (non-interventional) study aiming to collect data on the management and clinical outcomes of patients with gmg that received ravulizumab.

the polish, prospective, multicenter, observational, cohort study designed to collect longitudinal data on the management and clinical outcomes of patients with gmg naive to complement inhibitors who received ravulizumab in the scope of routine clinical practice within the frames of national drug program (ndp) for up to 42 months (\~ 6 months baseline and \~36 months follow-up).

Eligibility criteria:
inclusion criteria: * adult (aged ≥18 years) patients with gmg, naive to complement inhibitors, receiving ravulizumab treatment in the frames of ndp in poland. * patients willing to participate in the study and signed informed consent form (icf). * vaccination against n. meningitidis exclusion criteria: * those who plan to participate in gmg clinical trial on/after the date of first ravulizumab infusion through ndp. * cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Keywords: ravulizumab generalized myasthenia gravis gmg observational
application of intrahepatic arterial infusion chemotherapy for patients with high risk of liver metastases after pancreatic cancer surgery

Conditions: Pancreatic Ductal Adenocarcinoma; Who Have High CTCs Count in Portal Venous Blood; Liver Metastases

Summary: clinical results on intra-arterial adjuvant chemotherapy for prevention of liver metastasis following curative resection of pancreatic cancer

in this study, the investigator try to select 80 patients who received radical surgery for pancreatic cancer, whose circulating tumor cells(ctcs) count then performed on intraoperative portal venous blood to predict postoperative liver metastasis and were divided into two groups. for those who have high ctcs count may have more chance for the occurrence of postoperative liver metastasis was applied hepatic arterial perfusion chemotherapy with minimal dynamic randomization. the aim is to evaluate the feasibility of hepatic arterial infusion chemotherapy for the prevention of postoperative liver metastasis and improvement of prognosis of pancreatic cancer, so as to further improve postoperative management of pancreatic cancer

Eligibility criteria:
inclusion criteria: * pancreatic cancer patients who received the radical operation exclusion criteria: * who accepted chemotherapy before operation or who cannot or do not will to accepted enrolled into this study

Keywords: pancreatic ductal adenocarcinoma arterial infusion chemotherapy liver metastases
pet quantitative assessments of solid tumor response to immune checkpoint blockade therapy

Conditions: Melanoma; Renal Cell Carcinoma (RCC); Non-small Cell Lung Cancer (NSCLC)

Summary: this study aims to develop methods for quantitative imaging of solid tumors in patients who are receiving immunotherapies that have a delayed mechanism of action. pet imaging with \[18f\] 2-deoxy-2-(18f)fluoro-d-glucose (fdg) is a potent diagnostic tool and is able to detect melanomas and other tumors, some of which are undetectable by ct. fdg pet is now used commonly in detecting melanoma in humans as melanomas quite consistently have high glucose metabolism. pet with fdg can image the response of tumors to therapy, but has not been extensively evaluated in melanoma nor in immunotherapy for melanoma. pet has been shown to be highly predictive of outcomes of patients following radioimmunotherapy of lymphoma, and has shown changes in tumor glycolysis as early as 7 days after immunotherapy initiation. in order to develop pet/ct as a tool to detect early evidence of response in patients with solid tumors receiving immune checkpoint blockade, investigators propose to perform pet/ct imaging prior to therapy, again between days 21 and 28, and finally at 4 months post-treatment initiation. each scan will be assessed qualitatively and quantitatively. investigators will use the percist criteria to determine peak and maximum standardized uptake values corrected for lean body mass (sul) in tumor, tumor volumes, and tumor total glycolytic volumes, and will use ct from pet/ct to measure tumor size by immune recist criteria. (see section on outcome evaluation below.) investigators will assess whether early changes in tumor metabolism seen on fdg pet are predictive of progression free and overall survival outcomes. through these systematic pilot studies, investigators hope to better link fdg pet measurements to individual patient responses to immune checkpoint blockade therapy and better understand and refine this emerging and often effective therapeutic approach.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. any subject with documented metastatic melanoma, rcc or nsclc. 3. subjects must be scheduled to receive therapy, or received only one dose, with an anti-neoplastic agent that works by immune checkpoint blockade such as ipilimumab/yervoy (anti-ctla-4), mdx-1106/bms-936558 (anti-pd-1) or mdx-1105/bms-936559 (anti-b7-h1) mabs. 4. subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as \>10 mm with spiral ct scan. exclusion criteria: 1. patient is unable to provide informed consent 2. patient is pregnant 3. patient enrollment on research protocol which includes an additional mid-therapy investigational fdg pet/ct at approximately month from start of therapy.
acute response to left bundle branch area pacing with syncav

Conditions: Heart Failure

Summary: this clinical investigation is a prospective, single-arm, post-market, non-randomized, single-center study designed to evaluate the effectiveness of the syncav crt dynamic atrioventricular (av) delay feature when used with left bundle branch area pacing (lbbap).


Eligibility criteria:
inclusion criteria: 1. patient is 18 years of age and willing to comply with the study requirements 2. patients with approved indication for dual-chamber pacing or cardiac resynchronization therapy and scheduled to be implanted with an abbott pacing system 3. patient has documented left bundle branch block (lbbb) or intraventricular conduction delay (ivcd) 4. patient has an intrinsic qrs duration ≥ 130 ms 5. patient has intact av conduction with pr interval ≤ 250 ms exclusion criteria: 1. patient has a resting ventricular rate \> 100 bpm 2. patient has av block (2nd or 3rd degree) 3. patient has documented persistent atrial tachycardia or atrial fibrillation 4. patient has had a recent myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacing device programming changes in the opinion of the investigator 5. patient is currently participating in another clinical investigation 6. patient is pregnant or nursing 7. patient has other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results 8. patient does not have legal authority 9. patient is unable to read or write
evaluation of a novel patient warming system during mri

Conditions: Anesthesia; Hypothermia; Congenital Heart Disease

Summary: patients under deep sedation and general anesthesia lose heat to their surrounding environment. hypothermia after anesthesia is associated with worse patient outcomes, including increased number of infections and cardiovascular complications. cardiac mri scans performed for patients who require general anesthesia can cause a loss of body heat. several mechanisms exist for reducing hypothermia under anesthesia including forced air warmers, fluid warmers, radiant warmers, and chemical warmers. unfortunately, there are no mri-compatible systems which allow patient warming and prevention of hypothermia in anesthetized patient in the mri-scanner. this study is testing a non-invasive device that warms patients under clinically indicated general anesthesia in the mri scanner. this device will keep in the heat made by the mri scanner.

a. each group will receive the usual clinical care for having an mri under general anesthesia: 1. general anesthesia. the type of anesthesia used will be determined by the individual anesthesiologist, and will be the safest technique possible to allow for the desired mri images to be obtained. 2. all participants will be covered with 1-2 warm blankets before receiving anesthesia and while in the scanner as part of standard warming measures. 3. all participants will have continuous temperature monitoring during the scan. b. participants will be randomized to one of the three 1. 20 subjects will receive the standard of care which is 1-2 warm blankets. this group is called the control group. 2. 20 study subjects will have the mri-safe bore covering applied. this includes a clear covering sheet positioned over the openings of the mri scanner. 3. 20 study subjects will have the mri-safe bore covering applied, and in addition one opening of the covering sheet will be connected to a "bair hugger" ( an approved device which blows warm air). the second opening will act as a vent to let air out of the mri scanner bore. the bair hugger will be programmed to deliver forced air at 38 degrees celsius (approximately 100 degrees fahrenheit) into the contained space within the mri scanner. body temperature will be monitored continuously and documented in the electronic anesthesia record. the temperature of the forced air will be adjusted to maintain a goal body temperature of 36-38 degrees celsius (96.8- 100.4 degrees fahrenheit). image quality will be evaluated by the mri-technologist and mri -cardiologist subjectively.

Eligibility criteria:
inclusion criteria: 1. children \< 7 years of age. 2. undergoing medically necessary cardiovascular mri under general anesthesia exclusion criteria: 1.patients with fever (temperature \>38.5 degrees celsius) or condition which require active cooling at the time of mri

Keywords: anesthesia mri thermoregulation
southern methodist alcohol research trial (smart)

Conditions: Alcohol Consumption

Summary: the purpose of this study is to look at the effects of assessment, feedback and motivational interviewing on alcohol consumption among college drinkers.

excessive alcohol consumption has been a growing problem at many us colleges. in response, colleges and universities have instituted a range of alcohol intervention and prevention programs for students. motivational interviewing (mi) is one brief intervention that has been shown to reduce heavy drinking among college students. to date, all college studies of mi have used a format that includes an assessment and feedback delivered in an mi style. although this format has considerable empirical support, it remains unclear which of the components is necessary to produce behavior change. this study will evaluate the separate and collective effects of mi and feedback among "binge" drinking college students. additionally, this study will evaluate the effects of the initial drinking assessment, through including a delayed-assessment control group. after an initial screen, 350 students at southern methodist university who report at least one heavy (i.e., "binge") episode during the previous two weeks will be randomized to: (1) mi with feedback, (2) mi without feedback, (3) mailed feedback only, (4) assessment only, or (5) delayed assessment only. mi sessions will be delivered by trained and supervised counselors. participants will be assessed via a secure internet site at baseline, 3, 6 and 12 months (12 months only for the delayed-assessment group), with primary outcome measures including self-reported quantity and frequency of drinking, and drinking-related problems. since college drinking is associated with substantial negative effects for drinkers, as well as for others, the findings of this study may have significant public health implications in terms of reducing costs, and improving services for students who choose to drink.

Eligibility criteria:
inclusion criteria: * participants must be enrolled in southern methodist university. * participants must report one "binge" episode (4 or more drinks in one setting for women, 5 or more drinks in one setting for men) in the past two weeks. * participants must be at least 18 years old. exclusion criteria: * participants will be excluded if they are not enrolled at southern methodist university. * participants will be excluded if they do not report at least one "binge" episode in the past two weeks. * participants will be excluded if they are less than 18 years old.

Keywords: alcohol drinking college motivational feedback assessment