Kornimate/medical-research-clean huggingface dataset:
prospective evaluation of a commercially available hydrogel spacer

Conditions: Prostate Cancer

Summary: dosimetry efficacy evaluation of the hydrogel spacer

single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in 20 males undergoing radiotherapy to treat prostate cancer. study will utilize pre and post gel insertion ct images to determine the endpoints.

Eligibility criteria:
inclusion criteria: * males * at lease 18 years of age * undergoing external beam or brachy radiation therapy with a hydrogel spacer exclusion criteria: * invasive adenocarcinoma that is extracapsular and demonstrates posterior extension

Keywords: prostate prostate cancer spacer perirectal spacer
survival monitoring in russian cancer registries

Conditions: Melanoma; Breast Cancer; Oncology; Colon Cancer; Prostate Cancer; Survivorship; Lung Cancer; Cervix Cancer

Summary: this study aims to establish a holistic framework for continuous cancer survival surveillance in russian regions with high-quality population-based cancer registry data. the data from the population-based cancer registries of the northwestern regions of russia will be used to assess net and cause-specific survival trends.

the main sources of cancer incidence data in russia are population-based cancer registries (pbcr). national recommendations guide the content of corresponding variables stored in pbcrs. data were collected for the following regions: arkhangelsk oblast and nenets autonomous okrug (combined), republic of karelia, komi republic, vologda oblast, kaliningrad oblast, leningrad oblast, murmansk oblast, novgorod oblast, pskov oblast, and st. petersburg. quality assessment procedures will be applied to the population-based cancer registries (pbcrs) datasets. essential variables will be extracted following the recommended list of encr/iacr. the list of variables consists of two classes: original variables present in pbcrs datasets and synthetic variables calculated based on the original variables. "iarc/iacr tools for cancer registries" (iarc tools) software was used for the data cleaning, conversion to icd-o-3, and multiple primaries assessment. duplicates were removed by applying iarc/iacr/encr multiple primary rules. the analysis is limited to twenty years: 2000 - 2021. the federal state statistics service (fsss) is the primary regional and national mortality data source. however, the raw data from this source has several drawbacks. the main problem is the absence of the distribution of persons with undetermined ages and/or causes of death. the data sets for this research are obtained from the russian fertility and mortality database (rfmd) of the center for demographic research of the new economic school. the rfmd database is based on the fsss data but has a higher data quality due to the redistribution of deaths with the abovementioned characteristics. this source's population and mortality data contained the following variables: region, year, sex, age (5-year age groups from 0 to 85+), and cause of death. population data was obtained from the same source. the data were based on the 1989, 2002 and 2010 population censuses. it has been extrapolated to other years using annual statistics on mortality and births.

Eligibility criteria:
inclusion criteria: * men and women of any age * data record meets iarc/iacr tools for cancer registries requirements exclusion criteria: * severe patient data missing from a record

Keywords: survivorship survey survivorship care oncology melanoma breast cancer lung cancer
short term effect of glucocorticoids on brown adipose tissue thermogenesis in humans

Conditions: Brown Adipose Tissue

Summary: interventional, placebo controlled cross-over study to investigate the short-term effects of glucocorticoids (prednisone) on human brown adipose tissue.

active brown adipose tissue (bat) has recently been unambiguously discovered in human adults. active bat increases energy expenditure and improves glucose tolerance. pharmacological use of glucocorticoids (gcs) is widespread in clinical practice due to their high anti-inflammatory efficacy. while short-term administration even of high doses usually is well tolerated, long-term use of medium to high amounts of gcs leads to unfavorable metabolic changes, characterized by an increase in intra-abdominal fat mass, a decrease in muscle mass and insulin resistance. in line with these well-known side-effects of gcs, several in vitro studies and animal models demonstrate an inhibiting effect of gcs on bat thermogenesis.

Eligibility criteria:
inclusion criteria: * healthy male volunteers * bmi between 19-27 kg/m2 exclusion criteria: * cold induced thermogenesis of less than 5% basal metabolic rate (determined during screening visit) * contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, * history of depressive disorder, anxiety disorder * history of tuberculosis or latent infection * increased intraocular pressure * history of peptic / gastrointestinal ulcer disease * concomitant medication: non-steroidal anti-inflammatory drugs (nsaid), other glucocorticoids, diuretics, antihypertensives, fibrates or statins, metformin * other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus), * hypersensitivity to cold (e.g. raynaud syndrome) * allergy to local anesthetic * known or suspected non-compliance, drug or alcohol abuse, * inability to follow the procedures of the study * participation in another study with investigational drug within the 30 days preceding and during the present study, * previous enrolment into the current study, * enrolment of the investigator, his/her family members, employees and other dependent persons, * hypothyroidism without sufficient substitution * claustrophobia * mri incompatible implants * enrolment into another study using ionizing radiation within the previous 12 months.

Keywords: glucocorticoids brown adipose tissue cold induced thermogenesis
venetoclax combined with azacitidine and cag in refractory/relapse acute myeloid leukemia

Conditions: Refractory/Relapse Acute Myeloid Leukemia

Summary: this study aims to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine and cag as induction regimen in patients with refreactory/relapse acute myeloid leukemia.

this is an open-label, multicenter, phase ii clinical trial to assess the therapeutic efficacy and safety of venetoclax in combination with azacitidine (va) and cag (g-csf priming, low dose cytarabine, and aclarubicin) as induction regimen in patients with refreactory/relapse acute myeloid leukemia(aml). previous studies have shown that venetoclax plus intense chemotherapy represent promising efficacy in de novo aml patients with high complete remission rates and good tolerance. our preliminary results suggest that venetoclax in combination with azacitidine and cag are well tolerated and effective for patients who were diagnosed with refreactory/relapse aml. thus, this phase ii clinical trial is going to further explore its efficacy and safety. it is expected that about 42 patients will take part in this trial.

Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years old and ≤ 65 years old 2. refractory/relapse aml patients according to 2016 world health organization (who) classification; 3. eastern cooperative oncology group (ecog) performance status score less than 3; 4. liver function: total bilirubin ≦2 upper limit of normal (uln); aspartate aminotransferase (ast) ≦3 uln; alanine aminotransferase (alt)≦3 uln 5. renal function：ccr（creatinine clearance rate） ≧30 ml/min; scr (serum creatinine) ≦2 uln 6. heart function: left ventricular ejection fraction ≧45% 7. patients must participate in this clinical trial voluntarily and sign an informed consent form. exclusion criteria: 1. other diseases； 2. aml with central nervous system (cns) infiltration； 3. patients have received prior cag or va regimen before； 4. patients with a life expectancy \<3 months 5. patients with uncontrolled active infection; 6. hiv infection; 7. evidence of other clinically significant uncontrolled condition(s) including, but not limited to: a) chronic hepatitis b virus (hbv) or hepatitis c (hcv) requiring treatment. b) an active second cancer that requires treatment within 6 months of study entry 8. female who are pregnant, breast feeding or childbearing potential. 9. patients deemed unsuitable for enrollment by the investigator;
the impact of fitness on vascular dysfunction in adolescents with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the principal hypothesis of this study is that the micro and macro vasculature of young diabetes mellitus type 1 (dm1) patients is particularly susceptible to atherogenic factors which cause vascular dysfunction at multiple levels of the arterial vasculature and that this dysfunction is demonstrable using state-of-the-art ultrasound methods. the investigators further hypothesize that interventions, such as exercise, that are readily integrated into the daily life of individuals with dm1 can mitigate or reverse these early vascular changes and thereby diminish the otherwise predictable longer-term development of cardiovascular disease (cvd) in type 1 dm


Eligibility criteria:
inclusion criteria: you may be eligible if you are: * male or female, 12-18 years of age * healthy, no chronic illness other than dm1 * no medications that would affect the blood vessels * non-smoker * normal height and weight requirements for both groups (study 1) * two outpatient visits lasting \~1 to 1 ½ hours * 1 outpatient admission lasting \~ 10 hrs * most visits require blood draws requirements for second part of study for dm1 group (study 2) * two additional outpatient visits (one requires blood draw) * 12 weeks of an exercise program (5 days per week, 3 of them here at uva) * maintain healthy diet for those 12 weeks-you will have diet instruction * repeat outpatient admission as described above exclusion criteria: * under 12 or over 18 years of age * medication that could affect the blood vessels * smoker * above average bmi * chronic illness other than dm1

Keywords: type 1 diabetes adolescents exercise vascular function
color priming and patient decision-making in the emergency department: priming "threat" in patients with low-risk chest pain

Conditions: Chest Pain; Cardiac Event

Summary: this will be a prospective cross-sectional study evaluating a convenience sample of patients in the ed with low-risk chest pain defined by a heart score of 3 or less.

this will be a prospective cross-sectional study. we will evaluate a convenience sample of patients in the ed with low-risk chest pain defined by a heart score of 3 or less. patients will be consented for participation and will fill out one of two surveys concerning their chest pain and chances of adverse cardiac events based on their heart score. one survey will be printed in red text and feature red graphics; the other will be printed in black-and-white and feature black and-white graphics. the surveys will otherwise be identical. enrolled patients will be asked to fill out survey questions related to their perception of their safety and their comfort with their discharge.

Eligibility criteria:
inclusion criteria: * all patients 18 years or age and older presenting to the ed with a complaint of chest pain who are found to have a heart score of 3 or less. exclusion criteria: * patients who refuse to provide consent. * patients unable to fill out the survey due to clinical instability, severe pain, or disorientation as determined by an emergency physician. * incarcerated patients. * patients who have a heart score of \>3. * pregnant women.

Keywords: emergency department heart score
a study to evaluate sage-547 in participants with severe postpartum depression

Conditions: Severe Postpartum Depression

Summary: this is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of sage-547 injection in adult female participants diagnosed with severe postpartum depression.


Eligibility criteria:
key inclusion criteria: * participant either must have ceased lactating at screening; or if still lactating at screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug. * participant had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by structured clinical interview for dsm-iv axis i disorders (scid-i). * participant was less than or equal to (\<=) six months postpartum. * participant must be amenable to intravenous therapy. key exclusion criteria: * active psychosis. * attempted suicide associated with index case of postpartum depression. * medical history of seizures. * medical history of bipolar disorder. note: suicidal ideation was not an exclusion. other protocol-defined inclusion/exclusion criteria may apply.
to compare the efficacy of a prophylactic use of tenofovir by duration for the non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma, Burkitt's

Summary: the objective of this study is to analyze factors affecting hepatitis b virus (hbv) reactivation in anti-hbc positive patients with non-hodgkin's lymphoma treated with rituximab and compare hbv reactivation rates by duration of prophylactic treatment with tenofovir to contribute to the establishment of an effective prevention strategy.

this study will be conducted in a randomized, open-label, multi-center design. on day 1 of chemotherapy, approximately 90 subjects screened and determined eligible will be randomized to either group a or group b in a 1:1 manner for study participation. * group a: upon the eoc, subjects will receive tenofovir 300mg for approximately 6 months (24 weeks) and undergo treatment and follow-up every 12 weeks for up to 72 weeks post chemotherapy. * group a: upon the eoc, subjects will receive tenofovir 300mg for approximately 12 months (48 weeks) and undergo treatment and follow-up every 12 weeks for up to 72 weeks post chemotherapy.

Eligibility criteria:
inclusion criteria: 1. age of ≥ 18 (women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study during screening to rule out pregnancy. / a woman of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of tenofovir. / if the investigator obtains information concerning the pregnancy of a female patient, the investigator must terminate the study drug immediately in that patient, and report the information to irb in the same manner as for sae reporting) 2. cd 20 positive patients with non-hodgkin's lymphoma who are planned to receive anticancer treatment with rituximab based chemotherapy and a. ecog performance status 0-2 b. adequate renal function: serum creatinine level \< 2 mg/dl (177 μmol/l) c. adequate hematological function: hemoglobin ≥ 9g/dl, absolute neutrophil count (anc) ≥ 1,500/μl, platelet count ≥ 75,000/μl, unless abnormalities are due to bone marrow involvement by lymphoma d. expected residual life ≥ 6 months 3. serum hbsag negative, anti-hcv negative, but anti-hbc positive 4. alt \< 80iu/ml, serum bilirubin \< 3.0mg/dl, unless abnormalities are due to liver involvement by lymphoma or tumor lysis syndrome 5. individuals who were given and understood detailed explanations about this study, voluntarily decided to participate in the study, and provided written informed consent exclusion criteria: 1. child-pugh class c 2. other chronic liver diseases such as autoimmune hepatitis or wilson's disease 3. patient who has hypersensitivity to study drug 4. patient who has galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption 5. patient who is pregnant or on lactating. or who has plans for pregnant or lactation during study period even the partner of the male patient

Keywords: non-hodgkin's lymphoma tenofovir
a study comparing ezetimibe plus simvastatin versus simvastatin alone in patients at risk for heart disease (0653-023)(completed)

Conditions: Coronary Disease

Summary: this purpose of this study is to determine if the administration of ezetimibe and simvastatin together is more effective than simvastatin alone in lowering ldl-c levels to a goal of \<100 mg/dl in patients at risk for heart disease.


Eligibility criteria:
inclusion criteria: * men and women aged 18 to 80 at risk for heart disease who have ldl-c levels greater than or equal to 130 mg/dl and triglyceride level less than or equal to 350 mg/dl * patients must be able to maintain the national cholesterol education program diet throughout the course of the study exclusion criteria: * patients are excluded from the study if their weight is less than 50% of ideal body weight, if they are pregnant or lactating, have congestive heart failure, uncontrolled heart rhythm problems or a recent heart attack, coronary artery bypass surgery, or angioplasty. additionally, patients with poorly controlled type 1 or 2 diabetes mellitus, kidney disease, uncontrolled endocrine or metabolic disease, are known hiv positive, and uncontrolled high blood pressure
treatment of parental anxiety virtual reality (vr)

Conditions: Anxiety; Parents; Virtual Reality

Summary: the purpose of this study is to determine if non-invasive distracting devices (virtual reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations


Eligibility criteria:
inclusion criteria: * ages 18-99 (patient's parents will be enrolled) * able to consent exclusion criteria: * people who do not consent * significant cognitive impairment * history of severe motion sickness * current nausea * seizures * visual problems patients whose children are clinically unstable or require urgent/emergent intervention
effect of fenofibrate on kidney function: a six-week randomized cross-over trial in healthy people

Conditions: Healthy Volunteers

Summary: the purpose of this study was to test the effect of fenofibrate treatment on glomerular filtration rate (gfr), kidney hemodynamics and tubular function in middle-aged subjects with normal kidney function to further investigate the increase in creatinine levels observed in fenofibrate-treated subjects.


Eligibility criteria:
inclusion criteria: * male and female * age: 30-60 years old * subjects with normal renal function as documented by: plasma creatinine \ 80 ml/min * certified as normal by a comprehensive medical assessment and laboratory investigations the results of which are within the normal range /or clinically acceptable for the present subjects and who have a negative urinary screen for drugs of abuse. * written informed consent exclusion criteria: * body mass index (bmi) ≥ 30 kg/m² or \<18 kg/m². * pregnant, breast-feeding, or woman with child bearing potential without a reliable method of contraception. * having received an investigational drug in the last 90 days before date of inclusion. * with known hypersensitivity to fibrates. * unable or unwilling to comply with the protocol, or likely to leave the study before its completion. * who would undertake important change in physical exercise or vigorous sport competitions during the study period. * drug therapies are not permitted during the study, except contraceptive pill when applicable, with the exception of occasional use of paracetamol. * any administration of treatment, which could bring about induction or inhibition of hepatic microsomal enzymes within 3 months of the study start. * diabetes mellitus, heart diseases, kidney diseases, hypertension, asthma, liver diseases, chronic pancreatitis, or identified risk or known history of acute pancreatitis, known cholelithiasis without cholecystectomy, asat and/or alat \> 1.3 times uln, gastric or peptic ulcer or intestinal diseases, musculoskeletal diseases or increased ck \> 1.0 times uln, history of neoplasm, mental illness, regular user of sedatives, hypnotics, tranquillisers or any other addictive agents or who are known to be prone to alcohol abuse (i.e. history or evidence of acute abuse), or alcohol intake \>14 units per week (unit = ½ pint of beer, 1 glass of wine, 2,5 cl standard spirits), or heavy smokers (\>10 cigarettes/day), or excessive drinker of tea, coffee and/or beverages containing caffeine (\>8 cups/day), blood donor with recent donation (in the three months preceding the initiation of the study) or would make blood donations during the study, blood transfusion or administration of blood-derived products, in the year preceding the study.

Keywords: fenofibrate glomerular filtration rate inulin clearance creatinine healthy volunteers cross-over
optimizing a mobile health platform for sleep promotion and obesity prevention in children

Conditions: Insufficient Sleep; Obesity

Summary: the overall objective of this application is to develop a mobile health platform for the pediatric care setting to promote longer sleep duration for childhood obesity prevention.

insufficient sleep duration is highly prevalent in childhood and is associated with incident obesity, especially among middle school-aged children. investigators therefore need to identify strategies to increase sleep duration among children for obesity prevention. the overall objective of this application is to develop a mobile health platform for the pediatric care setting to promote longer sleep duration for childhood obesity prevention. this is a single-site study being conducted at the children's hospital of philadelphia (chop). investigators will randomize 325 children, aged 8-12y, with a body mass index (bmi) between the 50th-95th percentile, and who sleep \<8.5 hours per night. clinical measurements will be acquired at chop and sleep will be measured in the home setting. the way to health mobile platform will facilitate remote communication and data collection. a validated multi-channel sleep tracker will estimate sleep for 12-months (2-week run-in; 6-month intervention; ≈5.5-month follow-up). a randomized 24 factorial design will assess four components: sleep goal (fixed or modifiable), digital guidance (active or active with virtual study visit), parent incentive (inactive or active), and personalized feedback (inactive or active). the optimal component settings will have to meet the following criteria: increase average baseline sleep duration by ≥30 minutes for ≥75% of intervention weeks and for ≥50% of follow-up weeks. fat mass will be measured at baseline, 6-, and 12-months using dual energy x-ray absorptiometry (dxa). total energy intake and the timing and composition of meals will be measured using 24-hour dietary recalls at baseline, 6-, and 12-months. sociodemographic data will be measured using self-report approaches (e.g., sex, race/ethnicity) and home addresses will be geocoded for geo-spatial analyses.

Eligibility criteria:
inclusion criteria: 1. aged 8-12 years olds. 2. insufficient sleep duration (\<8.5 hours per night). 3. body mass index (bmi) between the 50th and 95th percentile for age and sex. 4. one child per family. exclusion criteria: 1. diagnosed with a chronic disease. 2. diagnosed with a behavioral health problem. 3. diagnosed with a condition that can impact sleep or growth. 4. diagnosed with a condition affecting physical growth and maturation or dietary intake. 5. children with a history of cancer, kidney, gi, musculoskeletal, or sleep disorders. 6. children who will transition to high-school during the study. 7. children using steroids/hormones. 8. children regularly taking medications

Keywords: insufficient sleep obesity