Kornimate/medical-research-clean huggingface dataset:
a post-authorisation non-interventional observational of patients in france with primary biliary cholangitis treated with obeticholic acid in real life

Conditions: Primary Biliary Cholangitis

Summary: post-authorisation non-interventional observational study of patients with primary biliary cholangitis who started ocaliva® treatment between october 1st, 2016 and december 31, 2017.

this is a non-interventional, multi-site, ambispective, national follow-up study of patients with primary biliary cholangitis who started ocaliva® treatment between october 1st, 2016 and december 31, 2017. this represents approximately 150 patients to date, who are therefore the first patients to have received treatment with ocaliva® in france outside of pre-approval clinical trials. all patients who received treatment within the context of the atu (conditional marketing authorization in france) or after eu marketing authorization approval for the product will be followed up for 18 months (this follow-up will be partly retrospective and partly prospective). the study therefore involves retrospective recruitment with retrospective and prospective data collection.

Eligibility criteria:
inclusion criteria: * patients with pbc treated with ocaliva® 5 mg or 10 mg according to the terms of ocaliva® approved smpc: in combination with ursodeoxycholic acid (udca) in adults with an inadequate response to udca or as monotherapy in adults unable to tolerate udca (over the age of 18 years at the time of treatment introduction). * patients with pbc with a suboptimal response to udca who received at least one dose of ocaliva®. * patients with or without an overlap syndrome (nguyen-khac e, 2004) * prior to any follow-up and inclusion in this cohort, the attending physician must give the patient or his or her legal representative or designated healthcare proxy information on the drug, a side effect report and notice of his or her inclusion in the cohort (patient information sheet in writing). * the patient (or his or her legal representative or designated healthcare proxy) must have read the information sheet and agreed verbally to take part, and must show the sheet to any doctor who is consulted. exclusion criteria: * diseases triggering a non-hepatic elevation of alkaline phosphatases (alp) (for example paget's disease or fractures within the previous three months). * participation in another investigational study on a product, biological material or medical device within the 30 days prior to selection. * inability to comply with the study follow-up procedures.
patient-reported outcome study of project echo for ild

Conditions: Interstitial Lung Disease

Summary: the study will assess whether patients of providers participating in project echo for ild experience reduced stress, including financial stress, based on their ability to receive timely and local care and services, the study will employ nested mixed-method design at baseline, at 6 months and at 12 months to answer the study question.

project echo (extension for community healthcare outcomes) is a knowledge-sharing model to expand the capacity of the health care workforce so that more people can get high quality care for their health conditions in or near the communities where they live. the model brings specialty disease expertise to community providers through its hub-and-spoke networks. the model relies on videoconferencing to connect local providers in non-urban or underserved communities (spoke sites) with an interdisciplinary team of specialist providers at academic medical centers (hubs) during virtual "teleecho" clinic sessions, which include brief educational lectures and case-based, experiential learning. the echo model addresses barriers of long wait times for a first appointment, the time and expense associated with long distance travel, and the disinclination to follow through on repeated care appointments in the face of these persistent barriers, all with the additional objective of achieving health equity. most patients perceive the diagnostic and care pathways in ilds as a major struggle because of lack of awareness about the diseases, delayed access to specialty centers, providers' focus on disease- versus patient-centered care, and lack of reliable information and education about the diseases and supportive care resources.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of interstitial lung disease * not be currently followed by an ild specialist at an academic institution or must live more than 50 miles away from an academic ild center exclusion criteria: -

Keywords: progressive fibrosing interstitial lung disease idiopathic pulmonary fibrosis interstitial lung disease associated with systemic sclerosis myositis-associated interstitial lung disease sarcoidosis hypersensitivity pneumonitis pulmonary fibrosis
the impact of omega-3 supplementation on gene expression in type 2 diabetics

Conditions: Type 2 Diabetes

Summary: the aim of this study is the comparison between the effects of supplementation with omega-3 or placebo for 10 weeks in type 2 diabetics

adipose tissue is recognized as an important endocrine organ in human. not only it has function of storing unlimited energy but also its secretory roles is subject to intense research in recent years. acylation stimulating protein(asp), retinol-binding protein 4 (rbp4) and lipocalin-2 (lcn2) are circulating adipokines elevated in diabetes. c5l2 is a g-protein-coupled receptor. activation of c5l2 by asp, has been shown. fatty acids may influence the expression of adipokines. epidemiological studies showed that omega-3 reduce the development of insulin resistance and diabetes. because fatty acids are the main component of adipose tissue, it is essential interest to clarify the biological effects of omega-3 on the expression of relevant adipokines.

Eligibility criteria:
inclusion criteria: * literate * willingness to participation * diabetic patients 30-65 years old * body mass index in the range 18.5-40 * avoidance of dietary supplements * vitamins and herbal products at least 2 weeks before and throughout the intervention exclusion criteria: * people who have used omega-3 supplements in last 3 months * having chronic renal disease * hepatic disease * gastrointestinal disease * hematological disorders * hypothyroidism or hyperthyroidism * treatment with orlistat or sibutramine for weight loss * pregnancy and lactation * treatment with insulin or thiazolidinediones

Keywords: asp lcn2 rbp4 c5l2
expectations and pain control advancement in surgery: the repair trial

Conditions: Abuses Over-The-Counter/Prescription Medications; Pain, Postoperative; Opioid Use; Physical Activity; Patient Dependence on

Summary: this is a randomized control trial that aims to evaluate whether patient-centered education, compared to routine education, decreases narcotic consumption without interfering with return to physical activity following hospital discharge. in addition, it will test whether patient-centered education decreases the quantity of narcotics prescribed and/or increases patient satisfaction and preparedness.

opioid use disorder is a national health emergency. opioid prescribing practices to treat post-operative pain have contributed to the problem. this study seeks to explore the effects of changing pre-operative education \& increasing patient input regarding post-operative receipt of opioids. the study will explore the effects that change in pre-operative education may have on post-operative opioid consumption juxtaposed upon return to physical activity using a randomized trial design. women undergoing pelvic floor reconstructive surgery will be randomized to either (i) standard pre-operative education (ii) modified, patient-centered pre-operative education. the investigators will monitor both post-operative opioid consumption and return to physical activity. the investigators hypothesize that investigation of patient's post-operative pain experiences and their inclusion in the educational and the shared decision-making process will likely decrease post-operative narcotic use without affecting return to function. our long-term goal is to develop a pragmatic and balanced approach to address pain concerns, decreasing the medical community's contribution to the opioid epidemic.

Eligibility criteria:
inclusion criteria: 1. subjects are ≥ 18 years of age 2. english or spanish speaking 3. patient scheduled for pelvic floor surgery exclusion criteria: 1. unable to speak english or spanish 2. using long acting opioids (e.g. ms contin, fentanyl patch) 3. primary or pain healthcare provider recommends against study participation (eg. if the patient has a history of opioid use disorder or other confounding problems, we will contact the primary care provider or pain healthcare provider for their recommendations regarding study participation)
antibodies to digoxin for bipolar disorder

Conditions: Bipolar Disorder

Summary: subjects suffering from bipolar disorders treated with specific medications will give their informed concent and will receive intravenously only one dose of digoxin antibodies (fab). their response to this therapy will be measured accordingly.previous medications will be not changed a base line serum endogenous digitalis-like compounds (dlc)levels will be measured using a specific laboratory technique and these compounds will be measured at 6 and 24 hours after fab therapy. patients also will be followed using clinical and psychological tests

twenty subjects suffering from bipolar disorders treated with specific medications will give their informed concent and will included in the study. all will receive in an open study only one intravenously dose of digoxin antibodies (fab). their response to this therapy will be measured accordingly.previous medications will be not changed a base line serum endogenous digitalis-like compounds (dlc)levels will be measured using a specific laboratory technique and these compounds will be measured at 6 and 24 hours after fab therapy. patients also will be followed using clinical and psychological tests

Eligibility criteria:
inclusion criteria: * admitted patients suffering from bipolar disorder * abillity to give informed concent exclusion criteria: * allergy to digoxin antibodies * renal and liver function impairment * liver cirrhosis * asthma * patients on digoxin or digitoxin * patients receiving aldactone therapy * heart a-v block * hypo or hyperkalemia on admission * potential suicidal behaviour

Keywords: digoxin antibodies bipolar disorder
pre-operative ultrasonographic evaluation of caval aorta diameter index as a predictor for post-induction hypotension

Conditions: Hypotension on Induction

Summary: comparison between ultrasound measurement of ivcd-aod index in prediction of post induction hypo tension

this study aims to evaluate the ability of preoperative ultrasound measurements ivc to aorta diameter index to predict post-induction hypotension in comparison with ultrasound measurements of the ivc collapsibility index.

Eligibility criteria:
inclusion criteria: * • adult patients (\>18years) * asa i-ii exclusion criteria: * • asa physical status \> ii * dyspnea * systolic blood pressure ≥ 180 mmhg * systolic blood pressure \< 90 mmhg * agitation (rass \> 1) * ivc non visualized * epidural catheter in use * patients with increased intraabdominal pressure (intrabdominal mass compressing ivc). * pregnancy
new therapeutic strategies for inhibitory control in alcoholism

Conditions: Alcoholism

Summary: this experimental research studies the efficacy of two different treatments for inhibitory control improvement in alcohol-dependent individuals, one consisting of retrieval-extinction learning ( alcohol aat task) and the other consisting in rtms of the right dorsolateral prefrontal cortex.

the main purpose of this study is to demonstrate the efficacy of two different treatments for inhibitory control improvement (measured by the modified stop signal task): a behavioral treatment based on retrieval-extinction learning, through the aat (alcohol approach avoiding task) and a treatment based on the neuromodulation of prefrontal cortex through the rtms (repetitive transcraneal magnetic stimulation) technique. to carry out this study, 105 alcoholic patients will be compared for clinical variables (abstinence/relapses), self-informed (upps) and behvavioral impulsivity (stop signal task), along with biological measures for polymorphism determinations. alcohol-dependent individuals will be divided into 4 groups of study (1:1 proportion for retrieval-extinction learning with aat and 2:1 (double for the effective technique comparing to placebo/control) for rtms): group 1 (n=30): exposure to an alcohol-related video followed by aat; group 2 (n=30): neutral-content video followed by aat; group 4 (30): active stimulation rtms (10 hz) ; group 4 (n=15): placebo stimulation sam.

Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 50 years old. * a minimum of 28 days of abstinence * consent to participate in the study. exclusion criteria: * subjects with other substance dependence ( with the exception of tobacco) * subjects with a history of brain injury or neurological diseases * denial for study participation * non-spanish speakers * rtms selected participants with be assed in order to discard epilepsy, presence for metallic elements and cns valves

Keywords: rtms aat alcohol-dependence relapses
applying the "new authority" model in the treatment of poorly controlled diabetic adolescents and their families

Conditions: Type 1 Diabetes

Summary: it is presumed that families of poorly controlled diabetic adolescents (type 1) would benefit from parents' counselling, guided by "the new authority" model.

"the new authority" model has been shown to be helpful in risk behaviors such as children's violence and school refusal. it is assumed the model would prove helpful in the risk behavior of lack of adherence to diabetes treatment regimen. the treatment is give to parents only, without the adolescent's participation. it is predicted to improve self care, parents' monitoring, family conflict and parents' helplessness.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes type 1 * condition duration a year or more exclusion criteria: * family does not speak hebrew * adolescent doesn't live at home * serious psychiatric condition in the family

Keywords: diabetes type 1 adolescents parents counselling
enhanced recovery in acute pancreatitis

Conditions: Acute Pancreatitis

Summary: prospective randomized-controlled trial evaluating impact of enhanced recovery protocol compared to standard care for recovery of patients with acute pancreatitis.


Eligibility criteria:
inclusion criteria: * acute pancreatitis confirmed by clinical history, serologic testing and/or radiographic imaging exclusion criteria: * • severe acute pancreatitis defined as the presence of any of the following: * organ failure (oxygen saturation\ 2.0, glasgow coma score\<15) * suspected or confirmed infected pancreatic necrosis: fever, leukocytosis in the setting of suspicious findings on cross-sectional imaging (gas within necrotic collection) or confirmed infection on fine needle aspirate * chronic pancreatitis or any chronic pain syndrome requiring use of narcotic analgesic within 30 days prior to hospitalization * abdominal surgery within 60 days prior to hospitalization * history of gastrointestinal motility disorder * inflammatory bowel disease * chronic comorbid illness including but not limited to \>new york heart association class ii congestive heart failure, cirrhosis, oxygen-dependent chronic obstructive pulmonary disease or malignancy other than non-squamous skin cancer not in remission. * documented allegy to any of the following medications: dilaudid, tylenol * patients transferred from an outside hospital for ongoing care * non-english speaking patients for whom an appropriate language interpretor cannot be identified. * pregnant women will be excluded from participation in this phase iib trial given the limited projected sample size and rarity of this condition during pregnancy. * minors (patients \<18 years of age) will not be eligible for study inclusion. the interventions being compared in the study protocol are standard care for adult patients with acute pancreatitis. however, the safety and efficacy of these treatments in the pediatric population has not been established.
singida nutrition and agroecology project

Conditions: Malnutrition

Summary: the purpose of this study is to test if a participatory, agroecological peer farmer-led education intervention can be effective at improving legume production, food security, and infant and young child feeding practices in singida district, tanzania.

approximately 40% of under five children in tanzania are stunted, with higher levels in rural areas. our inception research in singida identified five pressing issues faced by smallholder farmers that may contribute to this high rate of stunting. they are (a) hierarchical, or "top down" farmer education, (b) low soil fertility and little knowledge of agroecological solutions, (c) high levels of gender inequality and high workloads for women, (d) food insecurity and low dietary diversity, and (e) sub-optimal infant and young child feeding. singida nutrition and agroecology project (snap) is a randomized effectiveness trial of a participatory, agroecological peer farmer education intervention. each intervention village will choose 2 mentor farmers, 1 man and 1 woman, who will participate in a field visit to and training by existing mentor farmers in malawi and a two week long follow-up and refresher trainings in tanzania integrating agroecology, climate change, nutrition, and gender equality. mentor farmers will then conduct monthly visits to participating households and support the households in conducting experimentation with agroecological practices and/or new behaviors regarding nutrition and gender equality. quarterly meetings among mentor farmers and biannual meeting of participating farmers within each village will be held to discuss progress and challenges of peer education and household experimentations.

Eligibility criteria:
inclusion criteria: * are among the most vulnerable, as indicated by food insecurity * have a child who will be \<= 1 year old in february 2016 * are farmers who have regular access to the same farms/plots (but they do not need to own the land per se) * female headed households are acceptable, so long as not more than half the selected households in the village are female headed (to be able to detect change in gender equity) * willing to stay in study for 3 years, i.e. do not plan to move * interested in experimenting with new farming techniques exclusion criteria: * refuses to take part
chinese herbal medicine for gynecologic patients

Conditions: Dysmenorrhea

Summary: this is a prospective randomized-controlled trial looking at the safety and acceptability of using chinese herbal medicine in patients with primary dysmenorrhea. the research team hopes to enroll 100 patients, 50 of whom will be randomized to receive the herbal tincture and 50 who will receive a placebo tincture. patients will be enrolled and using the assigned tincture for twelve weeks. the research team will assess safety as a primary outcome by the presence or absence of adverse events related to study protocol during the period of participation.


Eligibility criteria:
inclusion criteria: * female aged 18-36 are met: * self-reported pain or discomfort during menstruation, as indicated by grade 1 or higher on the verbal multidimensional scoring system * may experience regular menstrual cycle and period must be \<7 days in duration * may be on birth control * must know or can estimate the date of the next cycle/period * may find blood clots in menstrual blood * must be in good health (doesn't report any medical conditions asked in the screening questionnaire) * following a stable, consistent diet regimen * follow a stable, consistent exercise regimen and are willing, for the duration of the study, to not decrease or increase the amount of exercise in their regimen * agree to refrain from any lifestyle changes that may affect their menstrual cycle for the duration of the study (for example, getting on or off hormonal birth control, reducing the amount of exercise) * follow a stable consistent regimen when using any other interventions, such as massage, chiropractic medicine, or acupuncture; agree not to increase or decrease the number of their other interventions * willingness to adhere to the dietary supplement regimen * willingness to refrain from any other dietary supplements targeting the menstrual cycle during the study period * is able to communicate in english * is willing and able to share feedback via redcap * must provide written informed consent (icf) exclusion criteria: * do not experience a menstrual cycle * cannot estimate the onset of their next menstrual cycle * do not experience menstrual pain or cramping * follow an extreme diet intervention * experienced severe weight loss in the past 3 months prior to study participation * if currently taking allowed supplements, the dosage needs to remain the same throughout the entirety of the study * food intolerances/allergies that require an epipen * known allergic reaction to any of the test product ingredients * currently pregnant, want to become pregnant for the duration of the study, or who are breastfeeding * previous users of elix cycle balance * having more than 3 alcoholic drinks a day * have been diagnosed with the following conditions: pcos, endometriosis, pmdd, adenomyosis, hashimoto's, anorexia, bulimia, orthorexia, binge eating, any other eating disorder * smokers * not been on a stable dose of birth control for the past 6 months