Kornimate/medical-research-clean huggingface dataset:
study of tvb-2640 in subjects with non-alcoholic steatohepatitis (nash)

Conditions: MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)

Summary: this is a phase 2 multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of tvb-2640 in subjects with non-alcoholic steatohepatitis (nash), a type of fatty liver disease. subjects will be randomly assigned to 1 of 2 treatment groups (tvb-2640 at one of three doses or placebo). following randomization, subjects will begin the 12-week treatment period and will receive once daily tvb-2640 or placebo.


Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years with a body mass index (bmi) ≤40 kg/m2. 2. prior liver biopsy within 24 months of randomization with fibrosis stage 1 to 3 and a non-alcoholic fatty liver disease (nafld) activity score (nas) of ≥ 4 with at least a score of 1 in each of the following nas components: * steatosis * ballooning degeneration * lobular inflammation and * confirmation of ≥ 8% liver fat content on mri-pdff. or, if prior biopsy is not available: * either overweight or obese or diabetic or alt ≥ 30 u/l or fatty liver on ultrasound and at least one more feature of metabolic syndrome by adult treatment panel iii (atp iii) criteria. and * magnetic resonance elastography (mre) ≥ 2.5 kpa and mri-pdff ≥ 8% during screening. exclusion criteria: subjects meeting any of the following criteria are not eligible for enrollment in the study. 1. history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening. note: significant alcohol consumption is defined as average of \> 20 g/day in female subjects and \> 30 g/day in male subjects. 2. type 1 diabetes. 3. uncontrolled type 2 diabetes defined as: * hba1c ≥ 9.5% during screening. (subjects with hba1c ≥ 9.5% may be rescreened). * basal insulin dose adjustment \> 10% within 60 days prior to enrollment. * requirement for glucagon-like peptide analogue or a complex oral anti-diabetic (oad) regimen (3 or more oads) within 6 months of screening. * history of severe hypoglycemia (symptomatic hypoglycemia requiring outside assistance to regain normal neurologic status) within the previous year. note: individual diabetes regimens will be reviewed by investigator and may be adjusted based on american diabetes association guidelines. 4. presence of cirrhosis on liver biopsy (stage 4 fibrosis) or imaging.

Keywords: nash non-alcoholic steatohepatitis fatty liver disease fatty liver liver diseases fasn fatty acid synthase inhibitor
pet scanning to evaluate zoledronate efficacy in metastatic prostate cancer

Conditions: Prostate Cancer

Summary: the primary goal for this trial is to assess the change in pet scans with the administration of zoledronate (bisphosphonate) therapy in patients with metastatic prostate cancer. it has been established that zoledronate therapy may play a role in delaying and reducing the incidence of skeletal events. researchers propose to evaluate the change in the uptake value of fmau pet scan after the zoledronate therapy. it has been demonstrated that fmau pet scans can successfully demonstrate and detect bony metastatic sites in prostate cancer. in addition, investigators would like to evaluate the change in the level of the prostate-specific antigen (psa) in the patient as well as outcome of bone scans.


Eligibility criteria:
inclusion criteria: * histological diagnosis of prostate cancer * evidence of metastatic disease by radiologic criteria * bone scan within 4 weeks of starting therapy * creatinine within 2 weeks of registration, calculated creatinine clearance \> 60ml/min. * minimum life expectancy of 6 months * willingness to have pre-therapy pet scans performed within 2 weeks after registration and post therapy pet scan performed within 1 week after dose of zometa (a total of 3 pet scans required) * calculated creatinine clearance \> 50ml/min. * no prior zoledronate therapy * patients must have disease progression despite testosterone suppression (level\<50ng/ml); progression can be by rising psa ( at least 2 values at least 2 weeks apart) or by new lesions on scans or progression of existing lesions on ct scan. * no concomitant systemic therapy for metastatic prostate cancer is allowed except lhrh analogue should be continued if necessary to maintain testosterone suppression. * no concomitant radiation therapy * prior rt is allowed if completed at least 2 weeks prior to registration. * presence of measurable or evaluable disease * if rt has been administered, disease outside the rt port is required. * willingness to sign informed consent. * registration and willingness to sign informed consent for separate pet protocol 2335 that describes the pet scan procedure. * patients must have good oral hygiene which includes having a recent dental evaluation exclusion criteria: * patients who are unable to swallow * patients with dental cavities that are likely to need dental extraction or root canal treatment as management

Keywords: prostate cancer metastatic zoledronate zometa
efficacy of pf-05089771 in treating postoperative dental pain

Conditions: Postoperative Dental Pain

Summary: the objective of this study is to evaluate the overall pain relief of a single dose of pf-05089771 against placebo following third molar extraction.


Eligibility criteria:
inclusion criteria: * oral surgery having removed 2 unilateral third molar teeth. * pre-dose pain intensity score (100 mm vas \[vas\]) of at least 50mm within 5 hours of oral surgery * pre-dose pain intensity score of moderate or severe within 5 hours of oral surgery exclusion criteria: * presence or known history of any clinically significant hematological, hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, allergic (including known drug hypersensitivities or allergies, but excluding untreated asymptomatic seasonal allergy) or any metabolic disorder that may increase risk associated with study participation, investigational drug administration or may interfere with interpretation of study results. * prior use of any type of analgesic or nsaid within 5-half lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure. * active dental infection at the time of surgery. * recent (within the previous 12 months) history of chronic analgesic or tranquiliser dependency. * any significant oral surgery complication at the time of surgery or in the immediate postoperative period, or oral surgery that has lasted more than 30 minutes (time from first incision to last suture placement). subjects who smoke more than 1 pack (20 cigarettes) per day, more than 3 cigars per day or use smokeless tobacco on a daily basis are excluded from the study.

Keywords: postoperative dental pain
geriatric covid-19 serology

Conditions: COVID-19

Summary: coronaviruses are important human and animal pathogens. at the end of 2019, a new coronavirus was identified as the cause of a cluster of pneumonia cases in wuhan, a city in china's hubei province. it quickly spread, leading to an epidemic across china, followed by an increasing number of cases in other countries around the world. in february 2020, the world health organization designated the disease covid-19, which stands for coronavirus disease 2019. the virus that causes covid-19 is sars-cov-2. the duration of protection during which a patient after infection and / or vaccination remains clinically protected and the evolution of their serology as well as their titre remains unknown


Eligibility criteria:
inclusion criteria: * age\> 75 years old * patient hospitalized or resident in the geriatrics center from july 1, 2020 to november 30, 2021 having presented with covid or having benefited from a covid vaccination. * subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research exclusion criteria: * subject having expressed opposition to participating in the study * impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.) * subject under guardianship, curatorship or safeguard of justice

Keywords: covid-19 sars-cov-2 elderly people geriatric rt-pcr sars-cov-2
comparison between the impact's score and the clinician's perception to predict the prognosis of severe and moderate traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: main objective : to compare the quality of the prognostic assessment, (adverse evolution at 6 months) of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the impact score. the pitié-salpêtrière hospital is conducting a study evaluating the clinician's prognostic assessment of severe and moderate traumatic brain injury compared to the prognosis described by the impact score. the investigators compare the quality of the clinician's prognostic assessment (adverse evolution at 6 months) of severe and moderate traumatic brain injury to the prognosis described by the impact score.

design: prospective, monocentric, pilot study. the study will be proposed to all patients admitted to the neurosurgical intensive care unit (icu) at pitié-salpêtrière hospital, following a traumatic brain injury (tbi), over a period of 1 year. around 100 patients will be included. day 1 : in the first 24 hours after traumatic brain injury, two clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit. the known prognostic variables as the impact score in the first 24 hours will be collected. day 7 : the same clinicians will respond to the research questionnaire assessing their patient's prognosis, including confidence in their prediction and experience in neurological intensive care unit. at 6 months : after 6 months, all patients or relatives will undergo a telephone interview (or if applicable during a follow-up visit in standard care) to assess the glasgow outcome scale (gos). this interview will be blinded to the clinician's prediction and the impact score. for patients identified as gos 3 or 4, a second gos telephone interview will be carry out in the following days (\<7 days), by a committee of adjudication composed of 2 examiners.

Eligibility criteria:
inclusion criteria: * patient aged 18 years or older, * hospitalized in the neurosurgical icu department of the pitié-salpêtrière hospital following a head trauma, * presenting a glasgow coma scale (gcs) ≤ 12 in the first 24 hours following the head trauma, * relatives informed of the research and not having objected to the patient's participation in the study. exclusion criteria: * opposition of the patient, * patient under the protection of justice, * pregnant woman, * modified scale of rankin\> 1 before the traumatic brain injury. * patient unable to speak french.

Keywords: severe and moderate traumatic brain injury prognosis impact score
targeted biopsy or standard biopsy for clinical significant prostate cancer detection

Conditions: Prostate Neoplasm

Summary: this randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of mpmri-targeted biopsy compared to transperineal standard biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.

prostate biopsy with multiple samples using a standardized template (standard biopsy, sb) under transrectal ultrasound (trus) guidance is the current standard diagnostic approach in suspicion of prostate cancer (pca). however, many biopsies are unnecessary or cannot detect clinically significant pca (cspca). with the introduction of multiparametric magnetic resonance imaging (mpmri) of the prostate and the improvement for pca detection and localization, an alternative procedure, known as mri-targeted biopsy (tb), has been shown comparable or even higher detection rates of cspca compared to trus-biopsy (sb). this randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of tb compared to sb (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.

Eligibility criteria:
inclusion criteria: 1. men more than 18 years old with clinical suspicion of prostate cancer; 2. serum psa ≤ 20 ng/ml within the previous 3 months; 3. suspected stage ≤ t2 on rectal examination (organ-confined prostate cancer) within the previous 3 months; 4. no evidence of psa increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis; 5. mpmri pi-rads v2 score 4 or 5； 6. able to provide written informed consent. exclusion criteria: 1. prior prostate biopsy or prostate surgery; 2. prior treatment for prostate cancer; 3. contraindication to mri (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min); 4. contraindication to prostate biopsy.
predictors of sepsis in ex-preterm infants

Conditions: Sepsis; Premature Birth

Summary: the aims of this study are to: * assess whether ex-preterm infants have a persistently immature immune system, which may decrease their ability to respond to infections, when they reach term-corrected gestational age. * examine whether clinical history, nutrition status, and microbiome composition are linked to the immune composition of term and ex-preterm infants and whether these variables can be used to predict the risk of developing sepsis or having an immunologic disease.

preterm infants have increased numbers of viral infections in childhood. they are also more likely to die from infection during the neonatal and infant periods than infants born at term. while studies have demonstrated that premature infants have decreased adaptive and innate immune responses compared with infants born at term, there has been little investigation into whether this impaired immunity improves and becomes similar to full term infants once the ex-preterm infants reach term-corrected gestational age. there have likewise not been studies to determine whether specific immune markers may predict the risk of developing sepsis. given the immaturity of the preterm immune system and the many potential infectious and inflammatory insults they are exposed to during the preterm period (infections, poor nutrition, stress, steroid therapy), there is also a possibility that the relative immune deficiency experienced by preterm infants may persist into infancy. the goal of this study is to determine whether former preterm infants have sustained differences in immunity compared to age-matched controls, which would have significant implications for infection risk and response to vaccination. additionally, this study hopes to examine whether certain immune system abnormalities make certain babies more likely to have a serious infection. the present study will assess composition and function of t and b cell compartments in preterm and former preterm infants.

Eligibility criteria:
inclusion criteria ex-preterm infant group: * infants born less than 37 weeks gestational age exclusion criteria for ex-preterm infant group: * infants born greater than 37 weeks gestational age inclusion criteria for term infant group: * infants born greater than 37 weeks gestational age exclusion criteria for term infant group: * infants born less than 37 weeks gestational age

Keywords: sepsis prematurity
biomarkers of renal dysfunction in neuroblastoma survivors

Conditions: Neuroblastoma Survivors

Summary: the main purpose of this study is to learn more about biomarkers of kidney function in the blood and urine of neuroblastoma survivors. a biomarker is a biological molecule found in blood, urine, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. a biomarker may be used to see how well the body responds to a treatment for a disease or condition.


Eligibility criteria:
inclusion criteria: * diagnosis of neuroblastoma between 0-18 years of age * \< 21 years of age at time of study enrollment * two or more years from completion of systemic chemotherapy and/or radiation therapy exclusion criteria: * patients treated with observation only * patients with multiple primary cancers

Keywords: kidney function biomarkers 19-160
a randomized controlled trial of diabetes screening immediately postpartum (dip)

Conditions: Pre-Gestational Diabetes; Type2diabetes; Pregnancy in Diabetic; Pregnancy, High Risk; Gestational Diabetes; Gestational Diabetes Mellitus in the Puerperium

Summary: to conduct a pragmatic, non-blinded randomized controlled trial (prct) of immediate in-patient postpartum ogtt prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum ogtt (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by gdm.

individuals with gestational diabetes (gdm) during pregnancy have up to a 10-fold increased risk of developing of t2dm. postpartum screening facilitates detection of impaired glucose tolerance and diabetes mellitus with the possibility for subsequent preventive and treatment interventions. the american college of obstetricians and gynecologists (acog) and the american diabetes association (ada) recommend screening individuals with gdm postpartum with a 75-g, 2-hour oral glucose tolerance test (ogtt) that includes a fasting blood glu-cose.4,6 this is historically performed at 4-12 weeks so that it will coincide with the timing of the typical postpartum visit. however, the rate of postpartum screening with the recommended method are low, as many individuals do not seek timely postpartum care-only a quarter to one half of individuals undergo diabetes screening in the first year postpartum. multiple structural barriers exist for patients and healthcare providers to effectively complete postpartum diabetes screening via the current recommended method. an immediate postpartum ogtt has been proposed as an alternative to the current standard practice which is generally performed between 4-12 week postpartum ogtt at the routine postpartum visit. an immediate ogtt has comparable performance characteristics for detection of impaired glucose tolerance and diabetes compared with a 4-12 week postpartum ogtt.

Eligibility criteria:
inclusion criteria: * immediately postpartum individuals during their delivery hospital admission * ≥ 18 years old with the ability to give informed consent. * diagnosed with gdm during pregnancy by: * elevated one-hour 50-gram glucose challenge test any time during pregnancy and provider documentation of gestational diabetes (not pregestational diabetes) diagnosis or * two elevated values on a 3-hour 100-gram glucose tolerance test any time in pregnancy and provider documentation of gestational diabetes (not pregestational diabetes) diagnosis * english or spanish speaking * receiving prenatal and postpartum care at osu exclusion criteria: * individuals who cannot tolerate a 2-hour oral glucose tolerance test (ogtt) (i.e. history of gastric bypass) * not english or spanish speaking

Keywords: 2-hour oral glucose tolerance test (ogtt) pregnancy diabetes mellitus screening
preferences for open vs. endovascular repair for abdominal aortic aneurysm

Conditions: Abdominal Aortic Aneurysm

Summary: this study tests the use of a decision aid for veterans who are facing a decision about surgery for their abdominal aortic aneurysm (aaa). the local site investigators (lsi) will enroll veterans with aaa who are candidates for endovascular or open surgical repair. there are 22-24 va medical centers participating in the trial. 12 sites will be randomly assigned to the intervention group, and 12 sites will be randomly assigned to the control group. twelve veterans will be enrolled at each site. at sites assigned to the intervention arm, veterans will receive a decision aid with information about the two types of surgery for aaa repair, open and endovascular, and complete a survey about their preferences. veterans at control sites will complete the same survey, but will not receive the decision aid. after their surgery, veterans will take another survey asking about their satisfaction. the lsi will compare the results of the survey between veterans' in the intervention and control groups to determine the effect of the decision aid on agreement between preference and repair type.

this is a cluster randomized trial comparing two ways to better align veterans' preferences and treatments for aaa: (1) a validated decision aid describing aaa repair types with a survey measuring veterans' preference for repair type -- versus (2) the survey alone. enrolled veterans will be candidates for either endovascular or open repair, and be followed at va hospitals by vascular surgery teams who regularly perform both types of repair. in aim 1, the investigators will determine veterans' preferences for endovascular or open repair and identify domains associated with each repair type. in aim 2, the investigators will compare agreement between veterans' preferences and repair type between the decision aid+survey and survey-alone groups. in aim 3, the investigators will investigate the facilitators and barriers of implementing a decision aid in a va surgical clinic. the investigators will identify factors associated with agreement. the investigators' findings will be reported to the national surgery office vascular surgery advisory board to help ensure veterans' preferences remain at the center of aaa treatment decisions. the investigators have recruited 20 va medical centers and their vascular surgery teams to participate in this trial.

Eligibility criteria:
inclusion criteria: * veteran with a \> or = 5.0 cm aaa who are candidates for both open and endovascular surgical repair, with no previous aaa repair surgery exclusion criteria: * veterans who are not candidates for both open and endovascular repair, and are less than \< 5.0 cm aaa in size