Kornimate/medical-research-clean huggingface dataset:
accessing care, clinical trials and screening for underserved children and adults with type 1 diabetes (access-t1d)

Conditions: Type 1 Diabetes; Celiac Disease

Summary: the purpose of this study is to identify people with t1d or celiac disease (cd) early in the course of their disease and to improve the methods of screening for these diseases.

the study will screen people who may be at risk for t1d because they have at least one person in the family with probable t1d. it can be a parent or a sibling. it can also be a second-degree relative, like nieces, nephews, aunts, uncles, grandchildren, or cousins. a relative of someone with t1d is at a higher risk of getting the disease as they are people with other autoimmune diseases. it is possible to detect t1d or cd before it shows any symptoms of high blood sugar. sometimes, particularly in people who develop t1d in adult life, the disease is misdiagnosed as type 2 diabetes. the treatment and care for the two diseases are different.

Eligibility criteria:
inclusion criteria 1. able to provide informed consent (adults 18 and above) and assent if seven or above. legally authorized representative (lar) is able to provide consent in case of minors or in case of adults unable to consent. 2. children \> 2 years and adults at elevated risk of developing (or having misdiagnosed) clinically evident stage 3 t1d because they have at least one of the following: i. have one or more first- or second-degree family members (siblings, parents, cousins, aunts/uncles, grandparents) diagnosed with type 1 diabetes or ii. have other autoimmune diseases such as but not limited to celiac disease, multiple sclerosis, rheumatoid arthritis or, thyroid disease or iii. those diagnosed with other forms of diabetes which are suspected of being t1d because of a bmi ≤28 or progression to insulin dependence within 3 years from diagnosis. 3. resides in the following counties: orange, seminole, osceola, lake, volusia, brevard, polk, hillsborough. exclusion criteria 1. people with a diagnosis of type stage 3t1d or t1d clinical definition per ada standards of care 2. history of organ transplant 3. be deemed unable or unlikely to comply with the protocol. 4. presence of any condition that, in the opinion of the investigator, compromises participant safety or data integrity or the participant's ability to complete study visit/s.
comprehensive geriatric assessment for frail older people with chronic kidney disease - the goal trial

Conditions: Frailty; Chronic Kidney Diseases

Summary: the goal trial addresses patient-prioritised research topics and outcomes and will be conducted, disseminated and implemented in partnership with patients and their caregivers. this will be the first study, internationally, to evaluate the clinical and cost effectiveness of comprehensive geriatric assessment (cga), a highly promising intervention for improving patient-important health outcomes in frail older people with chronic kidney disease (ckd).

there is an increasing number of frail patients with ckd, and multiple morbidities. many of them face rapid deterioration of health, referral to residential aged care facilities and loss of independence. this substantively impairs their quality of life and has societal ramifications, including very high costs of care. patients and carers are often overwhelmed by the multitude of decisions they have to make and may follow a care path that is in contrast to their goals. the goal trial addresses patient-prioritised research topics and outcomes and will be conducted, disseminated and implemented in partnership with patients and their caregivers. the primary objective is to test the hypothesis that in frail older people with stages 3-5 ckd, comprehensive geriatric assessment (compared with usual care) will increase attainment of patient-identified goals at 3 months follow up. the secondary objectives are to test the hypotheses that the comprehensive geriatric assessment will increase attainment of patient-identified goals at 6 and 12 months follow up, improve their quality of life and reduce frailty, hospital and residential aged care facility admissions while being safe and cost-effective. in this multicentre cluster randomised controlled trial, a total of 500 adult ckd stage 3-5 patients will be recruited. sites will be randomly allocated to either provide a comprehensive geriatric assessment to participants or usual care. the primary outcome measure is goal attainment scaling at 3 months follow up. the secondary outcome measures will be goal attainment scaling at 6 and 12 months, quality of life eq-5d-5l, frailty index, mortality, hospital and residential aged care facility admissions and cost-utility analysis.

Eligibility criteria:
inclusion criteria for screening: * moderate to severe ckd as determined by the treating nephrologist: * stage 3 = egfr 30 - 59 ml/min/1.73 m2 * stage 4 = egfr 15 - 29 ml/min/1.73 m2 * stage 5/5d = egfr below 15 ml/min/1.73m2, including patients receiving dialysis * aged ≥65 years, or ≥ 55 years if aboriginal or torres strait islander for inclusion in enrolment: * frailty index \>0.25 (fi-ckd tool) exclusion criteria: * estimated life expectancy of less than 12 months. * unable to provide informed consent and/or participate in the goal attainment scaling process due to cognitive impairment or another reason.

Keywords: goal attainment scaling frailty index
irrigation versus no irrigation for cutaneous abscess

Conditions: Cutaneous Abscess

Summary: in this study, the investigators are trying to find out if washing out the abscess (pocket of pus) with fluid will help, instead of only taking out the pus. your care will be the same as usual, except that you will be selected randomly to have your abscess washed out with fluid, or not.

irrigation of the abscess cavity is commonly described as part of the procedure of incision and drainage of cutaneous abscesses (1-4). despite this, there are no randomized controlled trials that demonstrate the benefit of irrigation in treatment of these abscesses. potential disadvantages of irrigation include increased procedural time, pain, increased cost with sterile irrigation solutions and materials to capture the irrigation effluent, and increased risk of microbiologic contamination of the surrounding area. the goal of this study is to examine patients undergoing incision and drainage of cutaneous abscesses to determine if irrigation of the abscess cavity affects the need for further interventions.

Eligibility criteria:
inclusion criteria: 1. all patients 18 years of age and above 2. patients that require a cutaneous abscess incision and drainage exclusion criteria: 1. unable to return for 48-hour followup. 2. patients being admitted to the hospital or going to the operating room for incision and drainage 3. pregnant patients 4. prisoners

Keywords: i&d abscess irrigation cutaneous abscess
heterologous effect of diptheria, tetanus, acellular pertussis vaccination on influenza challenge in the elderly

Conditions: Heterologous Effects of Vaccines

Summary: vaccines can have non-targeted or heterologous (also called non-specific) immunological effects on the immune system i.e. effects other than inducing an immune response against the disease targeted by the vaccine. this trial aims to evaluate the non-specific immunological effects of two vaccines - diphtheria-tetanus-acellular pertussis (dtp) vaccine and seasonal influenza vaccine - in a cohort of elderly humans (\>65 years of age) and healthy adult control subjects (30-50 years).

this prospective randomised study aims to investigate the heterologous immunological effects of dtp and seasonal influenza (flu) vaccination in an elderly tasmanian population and healthy adults. the study will assess whether prior or concurrent administration of dtp with seasonal flu vaccination affects generalised inflammation / immune homeostasis and gene expression, with a particular focus of inflammation reactive cells. it will also analyse for effects of dtp on the induction of vaccine-specific immunity to seasonal influenza vaccination (antibodies and cellular). volunteers will be randomised to one of three vaccine groups and serial blood samples taken for immunological assays for up to 30 weeks. the study is exploratory and will investigate vaccine effects on multiple immune parameters.

Eligibility criteria:
inclusion criteria: * two study groups 30-50 years old \>65 years old exclusion criteria: * unwell on day of vaccination * temperature \>38°c * active cancer * active autoimmune disease * diabetes mellitus * taking immunosuppressive drugs including steroids * any vaccination in last 3 months * dt or dtap vaccination in the last year * known allergy or contraindication to influenza or dtap vaccination * pregnant or breastfeeding
maternal pain catastrophizing score is related with children's postoperative circumcision pain

Conditions: Pain Catastrophizing

Summary: the aim of this study was to evaluate the relation of maternal pain catastrophizing score with child's who underwent circumcision postoperative pain. a cross-sectional study and this study was performed at the samsun university, samsun training and research hospital, samsun, türkiye. the mothers were divided into low pain catastrophizing (group 1) and high pain catastrophizing (group 2) group. children's postoperative pain intensity was measured using the visual analog scale (vas) and a faces pain scale (fps).

now, the study is continuing.

Eligibility criteria:
inclusion criteria: * age 5-12 years, * being operated under general anesthesia. exclusion criteria: * children without biological mothers, or with a parent other than the mother, * children aged under five or over 12, * history of previous surgery, * being operated under regional anesthesia, * use of analgesic, antiepileptic, or sedative medications, and * other procedures being performed in addition to circumcision (such as herniorrhaphy, tonsillectomy, orchiopexy, and appendectomy).

Keywords: postoperative pain circumcision pain catastrophizing mother children vas
study to compare the effect of treatment with carbidopa/levodopa/entacapone on the quality of life of patients with parkinson's disease. this study is not recruiting in the united states

Conditions: Parkinson's Disease

Summary: this study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the parkinson's disease-questionnaire 8 (pdq-8), in parkinson's disease patients with no or minimal, non-disabling motor fluctuations.

this study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the parkinson's disease-questionnaire 8 (pdq-8), in parkinson's disease patients with no or minimal, non-disabling motor fluctuations. treatment with carbidopa/levodopa/entacapone will be compared with treatment with standard formulation levodopa/carbidopa.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic parkinson's disease exhibiting at least 2 or 3 symptoms * motor functions must be regarded as non-disabling by the patient exclusion criteria: * history, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism * history of dyskinesia * previous or current use of entacapone or tolcapone * unstable parkinson's disease patients requiring/receiving regimens of levodopa * subjects taking levodopa/ddci controlled release or extended release formulations

Keywords: parkinson's disease, levodopa, motor fluctuations
digital spyglass confirmed common bile duct stones clearance without fluoroscopy

Conditions: Common Bile Duct Diseases; Stone - Biliary; Cholangitis, Sclerosing

Summary: this study aim to evaluated the effectiveness of digital spyglass cholangioscopy to facilitate common bile duct stone removal without fluoroscopy

patients this study recruited patients who suspected/confirmed cbds from clinical manifestation, liver function tests and imaging studies. with cbd sized between 5 and 15 millimeters, which measured from transabdominal ultrasonography (us), computed tomography (ct), magnetic resonance cholangiopancreatography (mrcp) or endoscopic ultrasonography (eus). the exclusion criteria were history of bile duct surgery, bile duct stricture, bile duct tumors, severe comorbid diseases, unstable vital signs, pregnancy, and coagulopathy. all patients were informed and wrote informed consent for the procedure. procedures non-fluoroscopic cbds removal was performed by experienced endoscopists, using standard side-viewing duodenoscope. after identified major papilla, the investigators performed bile duct cannulation with guidewire assisted technique. successful cannulation confirmed by visualized bile aspiration. if the patients had difficult cannulation, double guidewire technique was used. after the successful bile duct cannulation, the investigators performed endoscopic standard sphincterotomy (est). precut sphincterotomy was not used in this study. non fluoroscopic balloon extraction was performed. the balloon was pushed up to hilum then the investigators sweep until suspected complete cbd clearance. after that the investigators used digital spyglasstm to confirm the complete clearance of cbds. if spyglasstm showed residual cbd stone, the investigators repeat balloon extraction. if spyglasstm showed complete clearance, the investigator proceed to perform final cholangiogram as reference standard for this study.

Eligibility criteria:
inclusion criteria: * patients with clinically suspected/confirmed cbds * cbd caliber 5-15 mm exclusion criteria: * history of bile duct surgery * history of bile duct tumor * history of bile duct stricture * severe comorbidity * unstable vital signs * pregnancy * coagulopathy

Keywords: common bile duct stone cholangioscopy spyglass non-fluoroscopic
post-delivery maternal-offspring obesity and metabolic risk after a prepregnancy weight-loss intervention

Conditions: Overweight; Obese; Metabolic Disorders; Postpartum

Summary: the goal of prepared is to examine whether the prepregnancy weight-loss intervention administered during the prepare trial \[nct02346162\] has an influence in the postnatal period. prepared is a cohort study (no intervention) that will address new specific aims through one in-person visit with mothers and children, dietary recalls, actigraphy, and the use of medical record weights. the goal is to collect data when the child is 3 years old. however, due to the covid-19 pandemic, the investigators expanded the data collection window in order to collect data up to when the child is 5 years old. the investigators hypothesize that intervening on women before pregnancy is the key to breaking the multigenerational cycle of obesity.


Eligibility criteria:
inclusion criteria: * mother must be a prepare \[nct02346162\] participant who has experienced a viable pregnancy during the prepare trial * child must be the first viable offspring born to a prepare participant after consent into the prepare study exclusion criteria: none

Keywords: wellness/behavior change
targeting pathways in polycystic ovary syndrome (pcos) using metformin (met)

Conditions: Polycystic Ovary Syndrome

Summary: the investigator's global hypothesis is that women with polycystic ovary syndrome (pcos) can be separated into subtypes based on their response to metformin. the investigators propose here to use both targeted and non-targeted metabolomic approach to identify pathways associated with metformin's effect on insulin sensitivity and endothelial function. this pilot project will be the foundation for developing tailored therapeutic approaches to polycystic ovary syndrome and identifying novel drug targets.

the investigators propose to use both targeted and non-targeted metabolomic approaches to identify pathways associated with metformin's effect on insulin sensitivity, weight, androgens and endothelial function. this project will be the foundation for developing tailored therapeutic approaches to polycystic ovary syndrome and identifying novel drug targets. this pilot project is intended to inform the development of hypothesis and specific aims for a future grant application to national institutes of health (nih).

Eligibility criteria:
inclusion criteria: * body mass index (bmi) greater than or equal to 25 * polycystic ovary syndrome criteria of both oligomenorrhea (\ 8 or severe acne) or elevated testosterone\]. * taking no medications for the treatment of insulin resistance. exclusion criteria: * diagnosis of cushing's syndrome * untreated hypo/hyperthyroidism * elevated prolactin * congenital adrenal hyperplasia * renal insufficiency (creatinine \> 1.5) * diabetes * medications that can significantly affect endothelial function * pregnancy * breast feeding * taking oral contraceptives * currently smoking
evaluation the blood loss in pregnancies with misoprostol-induced labour

Conditions: Pregnancy; Induced Labor

Summary: the purpose of this study is to evaluate the blood loss in induced vaginal delivery by misoprostol and caesarians section with induction attempt.

methods: it was a study achieved with 101 pregnant women with indication to induced delivery labor that were evaluated by the hemoglobin dosage pre and post delivery for estimate the blood loss at delivery. patients were submitted to transabdominal obstetric ultrasound and basal cardiotocography. procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. the pills were administered each 6 hours in a maximum number of six. the control group was formed by 30 patients that began an spontaneously labor and 30 patients that achieved caesarians electively. the study of hemoglobin before and after delivery was evaluated through anova to repeated measures, where it was verified the time effect (pre and post delivery) and the effect of the group (with and without use of misoprostol).

Eligibility criteria:
inclusion criteria: * indication of early elective delivery by induction of labor (pre-eclampsia, hellp syndrome, chronic hypertension, prolonged gestation, diabetes mellitus, gestational diabetes, heart disease, thyroid disease; * pregnancy with living fetus; * vertex cephalic presentation; * estimated fetal weight by ultrasound \> 2500g and \<4000g; * amniotic fluid index (afi)\> 5 cm, except in cases of premature rupture of membranes in which afi \<5 cm would be allowed; * cardiotocography (ctg) antepartum normal; * bishop score less than or equal to 6; * determination of hemoglobin pre and post-partum. exclusion criteria: * prior cesarean section; * previous uterine scar by myomectomy; * fetal presentation anomalous; * evidence of fetal abnormal (ctg, ultrasound or doppler); * fetal growth restriction; * gestation multiple; * genital bleeding; * tumors, malformations and / or ulceration in the region vulvoperineal and birth canal; * no determination of hemoglobin pre-and post-partum;

Keywords: induced labor misoprostol postpartum blood erythrocyte indices vaginal delivery
deb-tace prior to liver transplantation in the treatment of hcc

Conditions: Liver Cancer

Summary: the goal of the study is to explore whether the usage of deb-tace (drug-eluting bead transarterial chemoembolization) prior to living donor liver transplantation can prolong the recurrence-free survival in patients with hepatocellular carcinoma (hcc). it is a single-center, exploratory study. the patients scheduled for living donor liver transplantation receive deb-tace 2 weeks prior to the surgery. the primary outcome: recurrence-free survival (rfs) the secondary outcome:1) overall survival (os)；2) pathological response rate (pathological response); 3) proportion of patients completing living donor liver transplantation; 4) adverse events related to deb-tace.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years; 2. subjects with viral hepatitis or cirrhosis are clinically diagnosed according to aasld standards, which require a history of viral hepatitis or cirrhosis combined with imaging examinations (enhanced ct, mri, second-generation ultrasound contrast agents). when the tumor diameter is greater than 2 cm, a diagnosis can be made if one imaging technique shows typical arterial phase rapid enhancement and rapid washout. if the diameter is 1-2 cm, two imaging techniques must confirm this, or one imaging technique confirms it and alpha-fetoprotein (afp) is greater than 400 ng/ml. for subjects who cannot be clinically diagnosed, histological or cytological biopsy confirmation is required; original biopsy records can also be used for diagnosis. 3. child-pugh score a-b grade; 4. tumor present in the right lobe of the liver; 5. liver cancer assessment meeting the "up to seven" criteria: the sum of tumor size and number does not exceed 7; 6. ecog-ps score 0-1; 7. scheduled for living donor liver transplantation as the primary treatment; 8. signed informed consent form. exclusion criteria: 1. presence of definite cancer thrombi in the main portal vein, vena cava, or main bile duct; 2. severe hepatic encephalopathy; 3. coexisting pulmonary arterial hypertension (moderate to high risk, who grade iii-iv); 4. severe contrast agent allergy; 5. irreversible hepatic artery to hepatic vein shunt; 6. special types of anatomical variations (asan portal vein type iii); 7. extrahepatic metastatic tumors; 8. concurrent active hepatitis or severe infection; 9. tumor dissemination or distant metastasis, expected survival \<3 months; 10. renal dysfunction, creatinine \>176.8 umol/l or creatinine clearance rate \<30ml/min; 11. white blood cell count \<3.0x109/l, platelet count \<50x106/l, and unable to correct; 12. inability to tolerate surgical anesthesia (severe infection, cardiopulmonary insufficiency, cerebrovascular disease); 13. severe psychiatric illness; 14. other reasons deemed unsuitable for participation by the investigator.
study of eribulin in children with cancer to determine safety

Conditions: Pediatric Cancer; Solid Tumors; Lymphoma

Summary: this is a study for children with cancer with no curative treatment options. the investigators will be giving eribulin, a new chemotherapy agent, for the first time to children. this study is designed to determine a safe dose the investigators can give to children in larger studies. the investigators will be monitoring the children on this study for the safety of the treatment and levels of eribulin in the blood after treatment. the investigators will also study the effect of the agent on the cancer.

this is a phase i study of eribulin, a novel tubulin inhibitor in children with relapsed and refractory solid tumors including lymphoma. dose escalation will be performed in a classic 3+3 design starting with 75% of the adult maximum tolerated dose (mtd). pharmacokinetics will be done on each patient. primary endpoint will be the pediatric mtd.

Eligibility criteria:
inclusion criteria: * age: ≤ 21 years of age at the time of study enrollment * diagnosis: refractory or recurrent solid tumors, including lymphomas, except those with cns tumors or known cns metastases * disease status: measurable or evaluable disease * adequate organ function as defined in protocol exclusion criteria: * pregnant or breastfeeding

Keywords: phase i pediatric cancer lymphoma eribulin