Kornimate/medical-research-clean huggingface dataset:
non-contrast enhanced mri in patients with c3 glomerulopathy (c3g) or immune-complex membranoproliferative glomerulonephritis (ic-mpgn) enrolled in the ach471-205 study

Conditions: C3 Glomerulonephritis; C3 Glomerulopathy; Immune Complex Membranoproliferative Glomerulonephritis; IC-MPGN; Dense Deposit Disease

Summary: functional and quantitative renal magnetic resonance imaging (mri) has seen a number of recent advances, and techniques are now available that can generate quantitative imaging biomarkers with the potential to improve the management of kidney disease. however, there are knowledge gaps that must be addressed before renal mri methods could be more widely adopted in clinical research and ultimately be transferred to clinical practice, including the biological basis of different mri biomarkers, and how the application of these biomarkers will improve patient care. among renal mri techniques, renal diffusion weighted mri (dwi) has been increasingly used in the last decade, showing high potential as a surrogate and monitoring biomarker for interstitial fibrosis in chronic kidney disease (ckd), as well as a surrogate biomarker for the inflammation in acute kidney diseases that may impact patient selection for renal biopsy in acute graft rejection. within the ready-to-start ach471-205 clinical trial, an open-label phase 2 proof-of-concept study in patients with c3 glomerulopathy (c3g) or immune-complex membranoproliferative glomerulonephritis (ic-mpgn) treated with ach-0144471, aimed at evaluating the efficacy of 12 months of oral ach-0144471 in patients with c3g or ic-mpgn, patients will undergo baseline and 12-month follow-up renal biopsies, and renal function will be assessed over time by estimated or measured (when available) glomerular filtration rate (gfr). adding multi-parametric nce-mri to the examinations under the ach471-205 study protocol will give the opportunity to elucidate, in a well-defined cohort of patients, the potential of nce-mri as biomarker of renal microstructure and functional change.


Eligibility criteria:
inclusion criteria: * diagnosis of c3g or ic-mpgn; * patients enrolled in the ach471-205 study at the bergamo center; * no contraindications to perform mri. exclusion criteria: - ferro-magnetic prosthesis, aneurysm clips, severe claustrophobia or other contraindications or exclusions interfering with the mri assessment.

Keywords: non-contrast enhanced mri diffusivity renal microstructure renal function c3g ic-mpgn
reducing binge eating to prevent weight gain in black women

Conditions: Binge Eating; Weight Loss; Weight Gain Prevention

Summary: the purpose of the proposed study is to pilot a 6-month, cognitive-behavioral binge eating intervention, appetite awareness training (aat) to reduce binge eating and prevent weight gain for black women with a bmi \> 25 kg/m\^2 and with weekly binge eating episodes. intervention participants will receive a 8-week group aat intervention, and will also receive bluetooth-connected scales for daily weighing. participants will also receive tailored feedback on self-weighing frequency and weight change. the investigators will follow-up with participants at six months.

aim 1. using an experimental design, examine the feasibility and acceptability of 6-month aat (n=40) in north carolina. forty overweight and obese (bmi ≥ 25 kg/m\^2) community-based black women will be randomized to the aat intervention or wait-list control (who will eventually receive the intervention). aat participants will meet weekly for 8 weeks, followed by a 4-month period of daily weighing and weekly tailored feedback only. the study will examine the following: recruitment feasibility, attendance/retention, adherence, satisfaction, and barriers to completion. aim 2: at 4 and 6 months, compare changes in (a) binge eating, eating self-efficacy, and depressive symptoms and (b) weight, blood pressure, and waist circumference for participants in the intervention vs. control group. h_1: participants in the aat intervention will report less binge and overeating and gain less weight than those in the control group at 2 and 6 months. secondary aim: examine characteristics (e.g., baseline bmi, severity of binge eating, frequency of self-weighing) related to change in binge eating and weight.

Eligibility criteria:
inclusion criteria: individuals are eligible if they are: * non-latino black women, * over 18 years of age, * have a bmi ≥ 25kg/m\^2, * use a bluetooth-enabled smartphone, * report at least one binge eating episode weekly, and * complete the screening. exclusion criteria: individuals will be excluded if they: * are currently pregnant, * are in substance abuse treatment, * are involved in another weight reduction program, * have a history of anorexia, * are purging, * are currently in treatment for eating difficulties, * are concurrent intravenous drug users or consume \>4 alcoholic beverages/day.
oxytocin, carbetocin and misopristol for treatment of postpartum hemorrhage: a multicentric randomized trial

Conditions: Postpartum Hemorrhage

Summary: postpartum hemorrhage (pph) is the leading cause of maternal death worldwide, with an estimated mortality of 140 000 per year. uterine atony is one of the most important causes of pph. the traditional treatment of which is the use of uterotonic agents. oxytocin is the most conventional drug which was proved effective. however, it has the shortcomings of short half life and the necessity of intravenous administration. misopristol, and more recently carbetocin were introduced for treatment of atonic ppp not responding to oxytocin. aim of the study is to evaluate the effectiveness of carbetocin, misopristol, and oxytocin for treatment of atonic pph.

the study will be conducted at the departments of obstetrics and gynecology of sohag, qena, al azhar, and assuit university hospitals, egypt. all patients with atonic pph who delivered vaginally will be invited to participate in the study. patients who delivered by caesarean section, with retained placenta, with traumatic pph, associated coagulopathy and those refused to participate in the study will be excluded. the patients will be randomly categorized into 3 groups; the first (n = 100) will receive 30 iu oxytocin intravenously; the second (n = 100) will receive 600 ug misopristol sublingually; the third (n = 100) will receive 100 ug carbetocin iv. the randomization will be done using opaque sealed envelops containing computer-generated codes. the primary outcome of the study is cessation of bleeding which will be judged by visual inspection of the blood loss by the trialist and by loss of \< 300 ml of blood during the first hour after enrollment. the secondary outcomes are time of control of bleeding (minutes), amount of blood loss till control of bleeding (ml), changes in the hemoglobin levels (gm) before and after treatment, changes in the hematocrite values (%) before and after treatment, the use of additional uterotonic drugs, the rate of complications (%), and the necessity for surgical intervention, and the cost of each medication. written consent will be obtained from all participants and approval from the local institutional ethical committee will be included.

Eligibility criteria:
inclusion criteria: * primary atonic postpartum hemorrhage after vaginal delivery exclusion criteria: * patients who delivered by caesarean section * retained placenta * traumatic postpartum hemorrhage * associated coagulopathy * chronic medical illness (hepatic , renal diseases) * refusal to participate in the study.

Keywords: postpartum hemorrhage, oxytocin, carbetocin, misopristol
plasmakinetic enucleation of the prostate and open prostatectomy to treat large prostates

Conditions: Benign Prostate Hyperplasia

Summary: the investigators hypothesize that plasmakinetic enucleation of the prostate (pkep) might yield functional results comparable to op but with lower perioperative morbidity, and have equivalent long-term efficacy with op for large prostates. the first objective was to demonstrate the non-inferiority of pkep compared to op concerning qmax at one year postoperatively. to explore the long-term efficacy, we compared the efficacy, safety, and morbidity of pkep with those of op in bph patients with prostate glands larger than 100 g over a follow-up period of 6 years.


Eligibility criteria:
inclusion criteria: * •qmax \ 19 * age between 50 and 70 years * prostate volume larger than 100 ml, as determined by trus post-void residual urine volume greater than 50 ml medical therapy failure. exclusion criteria: * •severe pulmonary disease or heart disease, coagulopathy, neurogenic bladder, bladder calculus, bladder cancer, prostate cancer, urethral stricture and previous prostate or urethral surgery
interleukin 38 as a biomarker for metabolic syndrome in psoriatic patients

Conditions: Psoriasis

Summary: case control study to compare level of interleukin 38 in patients with psoriasis and patients with metabolic syndrome with healthy control subjects

this case control study will measure plasma level of interleukin 38 in 4 groups of 24 subject, group one will have psoriatic patients, group 2 will have psoriatic patients with metabolic syndrome, group three will have patients with metabolic syndrome only, and group 4 will have healthy control subjects.

Eligibility criteria:
inclusion criteria: * specific to each group exclusion criteria: * patient refusal. age \<18 years pregnancy lactation smoking infections. patients with other inflammatory skin disorders use of antioxidant and anti-inflammatory drugs patients on treatment for psoriasis

Keywords: psoriasis metabolic syndrome interleukin 38
early and comprehensive care bundle in elderly for acute heart failure: a stepped wedge cluster randomized trial

Conditions: Acute Heart Failure

Summary: this is a prospective multicentre (n=15), stepped-wedge randomized trial that aims to evaluate the benefit of a protocolised comprehensive care bundle for early management of acute heart failure in the ed.

acute heart failure (ahf) is one of the most common diagnoses for elderly patients in the emergency department (ed), with an admission rate higher than 80% and 1-month mortality around 10%. there is scarce evidence of any clinical added value of a specific treatment to improve outcomes, and european guidelines for the management of ahf are based on moderate levels of evidence, due to the lack of randomized controlled trials. recent reports suggest that the very early administration of full recommended therapy may decrease mortality. however, several studies highlighted that elderly patients often received suboptimal treatment: for example, less than a third of them received nitrates therapy while it is recommended. furthermore, a recent preliminary study reported that only 50% of them are assessed for precipitating factors - although it has been reported that precipitating factors are independently associated with mortality. the hypothesis of the elisabeth study s is that an early care bundle that comprises early and comprehensive management of symptoms, along with prompt detection and treatment of precipitating factors should improve ahf outcome in elderly patients.

Eligibility criteria:
inclusion criteria: * patients aged 75 years and older admitted to the emergency department with a diagnosis of acute heart failure determined by the emergency physician, based on the presence of: * at least one of the following symptoms : acute, or worsening of dyspnea, orthopnea * one or more of the followings: pulmonary rales, peripheral edema, a chest radiograph or transthoracic echocardiography showing pulmonary vascular congestion signs, increased natriuretic peptides (bnp or nt-pro-bnp). * patients affiliated to french social security ("ame excepted") * written informed consent signed by the patient / the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will been signed by the patient (if need be by trustworthy person, family member or close relative) as soon as possible (article l1122-1-2 of the french public health code) exclusion criteria: * patients are excluded if they have any of the followings: * other obvious cause of acute illness (severe sepsis, st elevation myocardial infarction) * systolic blood pressure less than 100 mmhg * severe mitral or aortic stenosis, or severe aortic regurgitation * known chronic kidney injury on dialysis * shock from any cause * time from ed entrance to inclusion \> 6h * patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom

Keywords: emergency department elderly acute heart failure pulmonary edema
school-based obesity prevention program

Conditions: Obesity

Summary: the overarching goal of this initiative is to reduce the prevalence and occurrence of obesity and increase the remission of obesity in children and adolescents through implementation of a comprehensive school nutrition policy designed to promote changes in the school environment that will reinforce students' development of healthy eating and physical activity patterns inside and outside of school.

the proposed research aims to evaluate the effects of a school-based nutrition policy initiative on prevalence, incidence and remission of overweight (bmi \> 95th percentile). it is a partnership between the food trust, the school district of philadelphia and the university of pennsylvania. participants are approximately 1500 students from ten schools in grades four through eight. half of the schools were randomized to a comprehensive school nutrition policy initiative (snpi) based on cdc's guidelines to promote lifelong healthy eating. the snpi is a community-based intervention administered by the comprehensive school nutrition policy task force that is comprised of 40 individuals representing the public and private sectors. the goal of the snpi is to change the school environment to: support healthy eating, increase physical activity, and decrease the prevalence of childhood overweight and diet-related diseases. the remaining study participants are in five control schools, matched for ethnicity, ses, and type of food service. most students are african american and qualify for free and reduced meals at school (household income \< 185% of the poverty level adjusted for household size). assessments of weight, height, intake, activity, inactivity and eating disorder symptomatology are being conducted at baseline and 1 and 2 years.

Eligibility criteria:
inclusion criteria: * any child in 4th, 5th, 6th grades in study site schools exclusion criteria: * any child not in 4th, 5th, 6th in study site schools

Keywords: school-based obesity prevention
td-3504 sad in healthy subjects and subjects with ulcerative colitis (uc)

Conditions: Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects

Summary: this study is designed to evaluate the safety, tolerability, and pharmacokinetics (pk) of single-dose td-3504 and single dose 15n2-tofacitinib in healthy subjects and subjects with uc. the relative bioavailability of tofacitinib released from td-3504 compared to co-administered oral heavy-labeled tofacitinib (15n2-tofacitinib) will also be evaluated.


Eligibility criteria:
inclusion criteria: * male or female between 18 to 55 years old * male subjects must abstain from sexual intercourse or use a highly effective method of birth control * women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control * body mass index (bmi) 18 to 32 kg/m2 * willing and able to give informed consent * additional inclusion criteria apply inclusion criteria for ulcerative colitis (uc) subjects: * subject has a history of uc * subject is either not taking any medication for uc or has been taking a stable dose of ulcerative colitis medications for ≥ 14 days * additional inclusion criteria apply exclusion criteria: * is positive for hepatitis a, b or c, hiv or tuberculosis * has clinically significant abnormalities in baseline laboratory evaluations * subject has a clinically significant abnormal electrocardiogram (ecg) * participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening (or within 60 days prior to screening if investigational drug was a biologic, or is currently participating in another trial of an investigational drug (or medical device) * additional exclusion criteria apply exclusion criteria for healthy subjects: * use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy or standard daily multivitamin. * additional exclusion criteria apply

Keywords: active mild ulcerative colitis, active moderate ulcerative colitis, healthy subjects
dna methylation biomarker for diagnosis of cholangiocarcinoma in patients with bile duct stricture

Conditions: Cholangiocarcinoma; Biliary Stricture; DNA Methylation; Brush Cytology

Summary: dna methylation biomarker for diagnosis of cholangiocarcinoma in patients with bile duct stricture has high sensitivity and specificity compared with cytology from the brush specimens

the methylation of hoxa1, neurog1 were used to determine cholangiocarcinoma from brushed biliary samples. however, the sensitivity and specificity of this test for cholangiocarcinoma is still required.

Eligibility criteria:
inclusion criteria: * age more than 18 year old * patients had biliary stricture from cholangiocarcinoma and benign stricture exclusion criteria: * pregnancy * patient had other malignancy
pharmacoeconomic assessment in nabi-4514 and nabi-4515 phase 3 studies

Conditions: Smoking Cessation

Summary: the purpose of this study is to look at pharmacoeconomic data for subjects that have received either nicvax or placebo in the nabi-4514 or nabi-4515 studies.


Eligibility criteria:
inclusion criteria: * subjects who are eligible for randomization or have not reached week 12 in nabi-4514 or nabi-4515 studies. * subjects who agree to participate in health-related quality of life study. exclusion criteria: * subjects who are unable to complete a hrqol questionnaire because of inability to understand the language or due to mental impairment.

Keywords: pharmacoeconomic quality of life health outcomes smoking nicvax smoking vaccine smoking cessation
feasibility of a diet intervention for juvenile arthritis

Conditions: Arthritis, Juvenile; Arthritis, Childhood; Juvenile Idiopathic Arthritis

Summary: families of children with arthritis are highly interested in the benefits of diet to improve their child's disease and future health outcomes. previous research shows that the germs - bacteria and other organisms - that live in the intestines (gut microbiome) are important to how well immune systems work, and that what people eat changes their gut microbiome. the investigators want to study whether a certain diet - based on the principles of the mediterranean diet - will improve arthritis for children and whether it was changes in the microbiome that led to improvement. fifty-four participants in this study will change their diet for an 8-week period, and will have the option of remaining on the diet for an additional 4 weeks. at three time points during the study (beginning, 8 weeks, and 12 weeks), participants will provide stool and blood samples, will complete questionnaires about diet and other aspects of lifestyle and health, and will complete a disease assessment by a clinician. from collecting all these samples and information, the investigators will be able to determine if the diet was successful in improving disease activity in children with arthritis and if the gut microbiome was changed as well. this study will help the investigators figure out if a larger, and more definitive, study like this is possible to do in children with arthritis and will help the investigators design a bigger multinational study to confirm how diet affects disease outcomes and the microbiome in children with arthritis. if successful, this research will provide scientific knowledge to help families make their way through this difficult to- navigate topic.


Eligibility criteria:
inclusion criteria: * ages 8-18 years * diagnosis of jia (excluding systemic jia, enthesitis-related arthritis, and rheumatoid factor (rf) positive polyarthritis) as per international league of associations for rheumatology (ilar) criteria. (for this feasibility study, there will be no requirement for any particular level of disease activity.) * subjects on stable treatment - i.e., any medical treatment with disease-modifying antirheumatic drugs (dmards) and/or systemic or intraarticular corticosteroids, has been unchanged for 8 weeks, and is unlikely to change for 12 weeks as judged by the treating physician. * willingness to provide stool samples. * english or french fluency adequate to answer the study questionnaires, and participate in diet instruction, as judged by the enrolling physician. exclusion criteria: * documented specific food allergies, celiac disease. * co-morbidities that might impact the tolerability of the study diet, e.g., type i diabetes, peptic ulcer disease, etc.

Keywords: arthritis diet microbiome
earlysense monitoring device evaluation on chf patients

Conditions: Congestive Heart Failure

Summary: chf patients will be monitored using earlysense es-16 device and will simultaneously fill diaries and log their weight daily. the data collected and analyzed by the es-16 device will be correlated with the chf status data.


Eligibility criteria:
inclusion criteria: * age over 45 years old * chf class ii or iii with lvef\<40% * hospitalized at least once for chf deterioration over previous 12 month period * able and willing to cooperate with this trial for at least a 3 month period * home close to participating center exclusion criteria: * recent (within 3 month) admission to icu or cc-icu due to severe chf episode requiring artificial ventilation * asthma or copd

Keywords: congestive heart failure chf
mrna expression and genetic polymorphisms affecting drd3 (rs6280) and htr2a (rs6313) in bruxism

Conditions: Bruxism

Summary: the goal of this observational study is to learn about the genetic factors influencing bruxism, a condition characterized by teeth grinding, in a group of participants. the main questions it aims to answer are: * is there a significant association between the rs6313 polymorphism of the htr2a gene and bruxism? * is there a significant association between the rs6280 polymorphism of the drd3 gene and bruxism? participants will: provide dna samples for genotyping of the drd3 (rs6280) and htr2a (rs6313) polymorphisms. provide rna samples to assess changes in the expression of htr2a and drd3. researchers will compare the genetic data and rna expression levels between individuals with bruxism and those without (controls) to see if there are significant genetic differences and expression changes associated with bruxism.


Eligibility criteria:
inclusion criteria: * be above 18 years of age and have a confirmed diagnosis of bruxism exclusion criteria: * systemic diseases, * orofacial dysfunction, * acute symptoms such as neurodegenerative diseases (specifically parkinsons disease), * taking medication such as anxiolytics

Keywords: gene expression bruxism sleep bruxism polymorphism genetic