Kornimate/medical-research-clean huggingface dataset:
iga nephropathy biomarkers evaluation study (interest)

Conditions: IgA Nephropathy; Glomerular Diseases

Summary: this prospective cohort study is designed to examine the association between blood and urine biomarkers (including genetic variants) and long-term kidney disease progression among 2000 chinese iga nephropathy patients with relatively normal kidney function (egfr≥60 ml/min/1.73 m2).

glomerulonephritis is the leading cause of end-stage renal disease (esrd) in china, where iga nephropathy (igan) is the most common primary glomerulonephritis among individuals undergoing renal biopsy. the outcomes of igan vary highly among individuals; some have the stable renal function for lifetime and some quickly progress to esrd. no biomarker is widely applied to predict the outcomes in igan yet. previous gwas studies including ours have identified some susceptibility loci associated with the development and clinical features of igan. in addition, a few cohort studies have revealed several genetic loci related to the progression of igan. but, all of the reported gwas studies were based on a case-control design, which may not provide the information about the effect of genetic variants on the progression of disease. previous cohort studies which focused on certain specific candidate genes cannot unbiasedly explore the progression related susceptibility loci. furthermore, there is no study that integrates the information from whole genomic loci and serum and urine biomarkers to predict the long-term progression in igan. therefore, we design a relative large prospective cohort study to examine the association between blood and urine biomarkers (including whole genomic loci) and long-term kidney disease progression among 2000 chinese igan patients with relatively normal kidney function (egfr≥60 ml/min/1.73 m2).

Eligibility criteria:
inclusion criteria: * male or female individuals aged 14 years or older * patients with biopsy-proven primary iga nephropathy * a renal biopsy available for reviewing must include 10 or more glomeruli. * the first renal biopsy was performed within 3 years. * egfr ≥ 60 ml/min/1.73 m2 (mdrd formula); * individuals or their legal representative who are able to understand and have voluntarily signed the informed consent form (icf). exclusion criteria: * relatives were diagnosed with biopsy-proven primary iga nephropathy; * individuals had secondary iga nephropathy due to diseases such as diabetes, chronic liver disease and systemic lupus erythematosus.

Keywords: iga nephropathy biomarker
early mri prediction of crohns

Conditions: Crohn Disease

Summary: the investigators plan a prospective study designed to optimize and translate noncontrast, novel magnetic resonance imaging (mri) techniques for detecting and measuring intestinal inflammation as well as for allowing early prediction of response to medical therapy in small bowel crohn's disease (cd).

the investigators plan to evaluate novel mri techniques to measure: 1) mesenteric/intestinal blood flow using phase-contrast cine mri, 2) intestinal motility (peristalsis) using dynamic cine mri, and 3) bowel wall perfusion and molecular water diffusion. precise objective measurements of diseased bowel blood flow (in ml/min) and bowel motility (in contractions per minute) are not currently used in the clinical care of cd patients, while diffusion-weighted imaging is typically used in a qualitative manner. none of these techniques have been evaluated for predicting eventual response to therapy or correlated with endoscopic mucosal healing in pediatric or adult cd.

Eligibility criteria:
inclusion criteria: healthy control group -be able to tolerate up to 45 minutes in an mri scanner newly diagnosed crohns group * newly diagnosed, pathology-confirmed diagnosis of small bowel crohn's disease, * expected to receive infliximab (remicade; janssen biotech, inc.) or other anti-tumor necrosis factor (anti-tnf) medical therapy, * between 11 to 25 years of age and able to assent/consent, * be available for follow-up mri at 4-weeks and 6-months after the initiation of treatment, * be able to tolerate up to 45 minutes in an mri scanner. exclusion criteria: healthy control group * inability to obtain assent/consent, * inability to tolerate 45 minutes in an mri scanner, * contraindication to mri (e.g., mri incompatible implant or support device), * previous (remote) diagnosis or treatment of inflammatory bowel disease or other intestinal disease, * history of intra-abdominal surgery, including surgery on the intestine, * pregnancy. point-of-care urine pregnancy testing will be performed on all female study participants of reproductive potential (pediatric and adult) prior to each research mri exam. newly diagnosed crohns group * inability to obtain assent/consent, * inability to tolerate 45 minutes in an mri scanner, * contraindication to mri (e.g., mri incompatible implant or support device), * previous (remote) diagnosis or treatment of inflammatory bowel disease, * history of intra-abdominal surgery, including surgery on the intestine, * known bleeding disorder/coagulopathy (contraindication for adult subjects, as this may increase the risk of research colonoscopy), * pregnancy. point-of-care urine pregnancy testing will be performed on all female study participants of reproductive potential (pediatric and adult) prior to each research mri exam.

Keywords: crohn mri
ferrous sulphate supplement in women with iron deficiency anaemia

Conditions: Iron Deficiency Anemia

Summary: the purpose of this study is to investigate the pharmacokinetics of serum iron (the amount of iron in blood) after single oral administration of 2 tablets of l0008 80 mg (as ferrous sulphate) in women with iron deficiency anaemia.


Eligibility criteria:
inclusion criteria: * women 18-45 years old with iron deficiency anaemia * haemoglobin level between 85 g/l and 105 g/l * serum ferritin level \< 15 µg/l * d14 + 7 days of the menstruation cycle on the day of pharmacokinetic evaluation * standard diet exclusion criteria: * - anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure, * haemochromatosis or iron overload of secondary origin (blood transfusion), * long term treatment known to modify iron absorption, * gastro duodenal ulcer, * inflammatory bowel disease or any digestive disease which could modify iron absorption, * fructose intolerance, syndrome of malabsorption of glucose, galactose, deficit of sucrase-isomaltase, * serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders), * surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.
effect of long chain polyunsaturated fatty acids on behavior and cognition in children with attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the study investigates whether eicosapentaenoic/docosahexaenoic acid supplementation affects behavior and cognition in children with attention deficit hyperactivity disorder.


Eligibility criteria:
inclusion criteria: * adhd diagnosis * age 9-12y * native german speaker exclusion criteria: * allergy against fish and fish products * iq below 85 * objections against pork gelatine
paired promotion of colorectal cancer and social determinants of health screening

Conditions: Colorectal Cancer; Social Determinants of Health

Summary: this work is an implementation science study that examines different aspects of implementing a single intervention. the intervention consists of asking community health centers to implement an outreach strategy to screen patients for colorectal cancer and for social determinants of health in community health centers at the same contact point. these are both clinical targets that the chcs feel that their patients need and want to offer at a higher rate. the intervention consists of outreach to patients in need of colorectal cancer screening (crc) to offer fecal immunochemical test (fit) screening and screening for social determinants of health (sdoh). in this implementation science study, the intervention is an evidence-based intervention being implemented in real-world clinical practice. the intervention is the outreach to offer fit and sdoh, conducted by clinic staff. both evidence-based screening activities-fit and sdoh screening-are used in the practices included in the study but pairing them is intended to increase efficiency and patient-centeredness by addressing health related social needs that may impact patients' ability to engage in cancer screening. the study aims to test the effect of implementing the intervention on clinical and process outcomes. clinical outcomes are crc screening and sdoh screening. analysis of process outcomes includes measuring what organizational factors influence implementation.


Eligibility criteria:
study participants include community health center staff participating in interviews about the implementation of the intervention. up to four community health center staff members at each of the four community health centers will participate in key informant interviews twice per year. patients will receive the paired screening intervention as part of their routine care and will not be individually recruited for the study because the intervention is being offered as part of routine care. staff participants inclusion criteria: * staff from community health centers who facilitate screening * age 18 and older exclusion criteria: * have not participated in the implementation of the paired screening intervention

Keywords: implementation science colorectal cancer screening social determinants of health screening
to evaluate long- term safety and efficacy of luspatercept

Conditions: Thalassemia Major

Summary: an observational study to evaluate long-term safety and efficacy of luspatercept in subjects with transfusion dependent who received the first dose of luspatercept after its introduction in the clinical practice

luspatercept represents the first and only erythroid maturation agent (ema) approved by the european commission (ec) and the food and drug administration (fda) capable of enhancing advanced erythrocyte maturation. the efficacy of luspatercept was demonstrated in the phase iii clinical trial called "believe." with market authorization, the drug is used in less selected patients with potentially more complex medical histories than those enrolled in the registration study. in addition, it is now also possible to prescribe the drug in patients with blood consumption at baseline between 20 and 24 blood units in the 24 weeks before the drug was prescribed, who could not be included in the "believe" study. gathering data on the clinical characteristics of patients who are prescribed luspatercept in normal clinical practice, and of safety and efficacy in this setting, is essential to enrich the available information on this new therapy.

Eligibility criteria:
inclusion criteria: subjects who received at least one dose of luspatercept after its introduction in the clinical practice exclusion criteria: * subjects who received luspatercept after participating in the "compassionate" use program * subjects unwilling to sign informed consent
a study to assess an auto-injector being used to treat a migraine attack

Conditions: Migraine

Summary: the purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack. the study could take approximately 5 weeks and will include about 3 office visits to the study doctor, the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector. the last visit will be done by a telephone follow-up call.

investigational plan: 1. screening visit \[visit 0 / 0-14 days prior to receipt of study drug\] 2. baseline visit \[visit 1 / provision of study drug and subject training\] 3. treatment visit \[visit 2 / within 72 hours after study drug administration\] 4. follow-up visit \[visit 3 / telephone follow-up 7-10 days after study drug administration\]

Eligibility criteria:
inclusion criteria: 1. adults 18 to 60 years of age 2. prior effective use of injectable sumatriptan on at least two occasions within the last two months 3. at least two migraines per month suitable injectable sumatriptan 4. capable of using a migraine self-injection auto-injector 5. capable of distinguishing between migraine and other headache types (e.g., tension-type headache) exclusion criteria: 1. seizure disorders 2. coronary artery disease (cad) 3. cardiac dysrhythmia or pacemaker 4. high blood pressure 5. liver disease 6. kidney disease 7. autoimmune disease 8. history of alcohol or substance abuse 9. currently pregnant 10. use of any other investigational drug product within 30 days prior to treatment visit

Keywords: migraine
a phase 1b/2a, study evaluating the safety, pk/pd and efficacy of ns101 in healthy volunteers and ssnhl patients

Conditions: Seneorineural Deafness; Sudden Sensorineural Hearing Loss

Summary: the goal of this 2 step-up, exploratory study is to test safey, tolerability and pk/pd profiles in healthy volunteers and safety, tolerability and efficacy in sudden sensorineural hearing loss patients as an early salvage therapy. the main questions it aims to answer are: 1. whether is it safe and tolerable when healthy volunteers and sudden sensorineural hearing loss patients take multiple doses of ns101 against fam19a5 2. whether is it effective in reversing hearing capability in sudden sensorineural hearing loss patients who fails to show sufficient recovery despite of oral standard steroid therapy. patients and heathly volunteers will be given ns101 15mg/kg or 30mg/kg systemically less than 3 months per protocol. this is placebo controlled, double blinded study, which means there will be a group who receives placebo (i.e. fake drug) for study purpose.


Eligibility criteria:
part a: healthy volunteers part b: inclusion criteria: * unilateral ideopathic ssnhl greater than 55db at the average of 4 frequencies in pta (contralateral hearing is less than 30db) * those who started standard treatment within 5 days after symptom onset * those who were treated with oral steroids for 14 days, but incomplete recovery was confirmed as type iii/iv according to siegel's criteria at the end of the 14-day treatment exclusion criteria: * other otologic or systemic diseases * retrocochlear lesion

Keywords: sensorineural disease sudden sensorineural hearing loss sensorineural hearing loss sudden deafness cochlear synaptopathy hidden auditory synaptopathy
bacillus particles prevent children antibiotics associated diarrhea

Conditions: Antibiotic-associated Diarrhea

Summary: this prospective, multicenter, randomized, double-blind, placebo-controlled clinical study, into the group of children in the hospital that use clinical antibiotics from one month to three years old，by observing the given antibiotics at the same time with the whole bowel raw or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole bowel prevention clinical efficacy and safety of aad.

this prospective, multicenter, randomized, double-blind, placebo-controlled clinical study, into the group of children in the hospital that use clinical antibiotics from one month to three years old，by observing the given antibiotics at the same time with the whole bowel raw or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole bowel prevention clinical efficacy and safety of aad. outcome measures 1. main outcome measures: the incidence of diarrhea (stool frequency and character daily rates), the duration of diarrhea, the degree of diarrhea occur. 2. secondary outcomes: intestinal flora and relevant metabolites, micro-environmental changes.

Eligibility criteria:
inclusion criteria: 1. children aged 1-3 years 2. no diarrhea-related symptoms 3. the diagnosis of lower respiratory tract infection (acute bronchitis, pneumonia) in hospitalized children 4. the need for penicillins, cephalosporin antibiotic treatment, treatment for 7-14 days, combined with other antimicrobial agents alone 5. parent or guardian signed informed consent (6）not used in children with related traditional chinese medicine injection exclusion criteria: 1. diarrhea in the group, or 2 weeks before admission into children with diarrhea 2. children with icu wards, digestive tract malformations, children with gastrointestinal surgery, congenital heart disease, artificial heart surgery, children with rheumatic heart disease, infective endocarditis 3. receiving immunosuppressive agents in children 4. children who received any probiotic preparation 2 weeks before enrollment
prediction of clinical outcome in axillary block

Conditions: Pain, Chronic

Summary: the primary endpoint of this study was to identify that perfusion index (pi) has any predictive value for the treatment outcome of cervical radiculopathy

the interscalene brachial plexus block is an effective intervention for reducing postoperative pain but is related to side effects, suprascapular nerve block and a block of the axillary nerve have been introduced as alternatives to the interscalene brachial plexus for the control of postoperative pain. previous study demonstrated new method of axillary block using interfascial plane injection guided by ultrasoud. axillary block has been used widely for the relief of postoperative arm pain. recent study deomonstrated good pain relief when ultrasound guided fascial plane injection was performed in patients with cervical radiuculopathy. the perfusion index (pi) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. although the special probe for pi measurement is relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its use progressively. pi has been used widely for the prediction of success of brachial plexus block or axillary block. changes of pi ratio value showed an excellent predictive value for the success of block. there have been no studies demonstrating any predictive value of pi in axillary block for the relief of cervical radiulopathy

Eligibility criteria:
inclusion criteria: * cervical foraminal stenosis * cervical central stenosis * cervical disc herniation * cervical spondylolisthesis exclusion criteria: * infection * pregnancy * allergy to local anesthetic agents * previous cervical spine surgery
study of the effect of vedolizumab on intestinal microecological changes and its efficacy in the treatment of ulcerative colitis

Conditions: Ulcerative Colitis

Summary: inflammatory bowel disease is a group of chronic, non-specific inflammatory diseases of the intestinal tract whose etiology has not yet been fully elucidated, including ulcerative colitis and crohn's disease. vedolizumab, a novel biologic agent, is a recombinant humanized monoclonal antibody that specifically antagonizes intestine-selective α4β7 integrins on the surface of leukocyte subsets, thereby preventing migration of leukocyte subsets from the blood to the intestinal mucosa and reducing local inflammation in the gut. in this study the investigators propose to build on an existing cohort and analyse, by means of a multi-omics approach, the baseline gut microbial composition and abundance, intestinal and serum metabolome characteristics of uc patients and their changes during treatment, to predict the functional mechanisms by which these changing characteristics influence the therapeutic response to vindolizumab.

stool and blood samples etc. were taken from a cohort of patients with ulcerative colitis treated with vedolizum at the department of gastroenterology, second affiliated hospital of zhejiang university school of medicine as well as from a cohort of normal volunteers. stool and blood samples from uc patients were analyzed at baseline and at 14, 30, and 52 weeks after starting treatment. analysis of changes in gut microbial composition and abundance, gut and serum metabolome characteristics during 52 weeks of treatment in patients with uc. a model for predicting the efficacy of vedolizumab treatment by baseline gut microbial composition and abundance, and gut and serum metabolomic characteristics in patients with ulcerative colitis was developed in conjunction with clinical information from patients in the cohort. based on the model developed, clinical and gut microbial composition and abundance, gut and serum metabolomics data from other uc patients published in public databases were combined to confirm the results already found using the uc cohort at our center.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older, with moderate to severe ulcerative colitis, with an indication for vedolizumab treatment; 2. consent to participate in the study, read and sign the informed consent form; 3. no previous treatment with vedolizumab; 4. never undergone biologic therapy or at least suspended previous biologic therapy for more than 12 weeks; 5. not taking antibiotics or probiotics within the past 4 weeks. exclusion criteria: 1. younger than 18 years of age; 2. pregnant or breastfeeding women; 3. patients who require the assistance of a surrogate, witness, or who are otherwise unable to complete the trial unaided; 4. other conditions that, in the opinion of the investigator, are unsuitable for enrollment or affect the subject's ability to complete the study; 5. have taken antibiotics or probiotics within the past 4 weeks; 6. have received prior treatment with vedolizumab.
clinician communication about sexual health

Conditions: Breast Cancer

Summary: the objective of this study is to adapt a previously tested brief intervention aimed at enhancing clinicians communication about sexual health (ishare) to a mobile web-based platform showcasing a two-part podcast and to assess the feasibility, acceptability, and preliminary effects of the intervention in breast cancer clinicians.

specific aims are: 1) to assess the feasibility and acceptability of ishare in a mobile learning (mlearning) format and 2) to assess the preliminary effects of ishare in a mlearning format.

Eligibility criteria:
inclusion criteria: * clinician is a medical oncologist or medical oncology advanced practice clinician (nurse practitioner, physician assistant) who treats breast cancer patients exclusion criteria: * clinician has participated in previous pilot study of the intervention