Kornimate/medical-research-clean huggingface dataset:
value of mrcp+ and liver multiscan in the management of dominant strictures in primary sclerosing cholangitis

Conditions: PSC; MRI

Summary: primary sclerosing cholangitis (psc) is a chronic progressive biliary disease. due to the heterogeneous disease course and the relatively low clinical event rate of 5% per year it is difficult to predict prognosis of individual patients. novel imaging techniques called mrcp+ and liver multiscan (lms) hold the prospect of adequate depicting and quantifying lesions of the biliary tree as well as capturing functional derailment. however, these features must be tested first. the purpose of this study is to assess the (i) ability of mrcp+ to detect change in biliary volume, (ii) reproducibility of mrcp+ and lms, and (iii) correlation of mrcp+ with erc findings as gold standard.

after informed consent, patients will undergo standard care with blood tests and mri/mrcp. while performing the mri, additional sequences called lms are performed. thereafter, an ercp will be performed. approximately 8 weeks after ercp, another mri/mrcp and lms will be performed. also, blood tests will be performed and a clinician will evaluate the clinical condition and complaints of patients images will be coded and analysed by perspectum to retrieve mrcp+ and lms results.

Eligibility criteria:
inclusion criteria: * established diagnosis according to the ipscsg definitions (22) * age ≥ 18 * able to give informed consent * clinically suspicious for a dominant stricture exclusion criteria: * insufficient image quality * known allergy for mri contrast agents

Keywords: liver multiscan mrcp+
a phase ⅳ clinical trial of the recombinant hepatitis e vaccine (escherichia coli)

Conditions: Hepatitis E

Summary: this phase iv clinical study was designed to evaluate the safety and immunogenicity of the recombinant hepatitis e vaccine(hecolin®), manufactured by xiamen innovax biotech co., ltd., in healthy volunteers aged over 65 years of age at enrollment. the study volunteers will receive the 3 doses of hecolin® administered intramuscularly according to a 0-1-6 month schedule.


Eligibility criteria:
inclusion criteria: 1. healthy people aged over 18 years old on the day of enrollment 2. axillary temperature is below than 37.0 ℃ 3. blood pressure is not higher than 160/100 mmhg (with or without any medicine) 4. judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations. 5. able to understand this study information and willing to comply with all study requirements. 6. willing to participate in this study and sign informed consent form. exclusion criteria: 1. participated in any other clinical trial during the study period. 2. use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period. 3. received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment. 4. administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period. 5. administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study. 6. had a fever (axillary temperature over 38°c) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination. 7. immunodeficiency (such as hiv carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response). 8. history of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain. 9. pregnant or breastfeeding 10. allergic history to any component of this vaccine. 11. other medical, psychological, social or occupational factors that, according to the investigators' judgment,might affect the individual's ability to obey the protocol or sign the informed consent.

Keywords: hepatitis e
resilience and modification of brain control network following november 13

Conditions: Post-Traumatic Stress Disorder

Summary: this is a multiwave longitudinal neuroimaging study in a cohort of direct survivors of 11/13 paris terrorist attacks. both structural and functional brain imaging data will be collected at 8-12 months, 3 years, and 6 years after trauma in exposed participants as well as in control non-exposed participants. this project will capitalize on recent evidence showing that healthy participants can prevent unwanted images from entering consciousness using inhibitory control and memory suppression techniques, disrupting traces of the memories in sensory areas of the brain, and weakening their vividness and later reentrance. this process is believed to be affected in post-traumatic stress disorder (ptsd) which is characterized by anxiety and persistent intrusive memory of the traumatic event with highly distressing contents. this project will thus provide a unique opportunity to observe the online and structural dysfunctions of intrusion control network following a severe psychological trauma and how such process may contribute to recovery and psychopathological dynamics. in addition, the disruption of social cognition and emotional processing following ptsd will also be investigated in relation to disrupted inhibitory control functioning.


Eligibility criteria:
inclusion criteria: * participants between 18 and 55 years old. * present at the scene of the attacks the evening of 13 november 2015 or inhabitant of one of the neighbourhood affected by the attacks (exposed group), or persons were not in paris on the evening of the attacks and not residing in paris and its region (unexposed group). * affiliated to the french national health care system * have a good knowledge of the french language * right-handed * body mass less than or equal to 35kg/m2 * signed written consent form exclusion criteria: * pregnancy or intent to get pregnant * person deprived of their liberty * person admitted to a health or social institution for purposes other than research * minor * person subjected to an exclusion period related to another protocol * history of severe psychiatric disorders before the attacks : psychotic disorders, bipolar disorder, obsessive compulsive disorder and / or substance use disorders (excluding tobacco addiction) * use of medication that may interfere with cognitive or cerebral functioning * presence of visual or hearing troubles that may compromise participant's ability to participate in the study * mri contraindications
optimal length of treatment continuation with olanzapine after remission of manic or mixed episode

Conditions: Bipolar Disorder

Summary: this is a randomized, parallel, open-label study of patients who have responded to treatment in the acute phase of their manic or mixed episode, with or without psychotic symptoms, with olanzapine in mono or co-therapy, and who are in syndromic and symptomatic remission at the time of enrollment into the study.


Eligibility criteria:
inclusion criteria: * outpatients, male or female, at least 18 years old * patient or legal representative must understand the study and sign an informed consent document before any study procedure * must have a diagnosis of bipolar disorder type i and have a recent manic or mixed episode, with or without hospitalization, according to dsm-iv-tr criteria. * patients must be in syndromic and symptomatic remission, following dsm-iv-ir criteria, for the manic or mixed episode, at the time of study entry, with a total score for ymrs less than or equal to 12 and total store for hamd less than or equal to 8 at visit 1 and 2. * remission must have been achieved taking olanzapine in mono or co-therapy, and it must have been maintained until study entry. * patients must have had, at least, 2 manic or mixed episodes within 3 years of the study entry, taking into account the current one. exclusion criteria: * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry, or with a study drug in other clinical trial * patients without symptoms or manic or mixed episode within one month of study entry. * confirmed diagnoses of schizophrenia or other psychotic disorders (schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, substance-induced or medical condition psychotic disorder, psychotic disorder nos),following dsm-iv-tr criteria. * patients that have achieved remission with ect (electro convulsive therapy) in addition to psychopharmacological treatment * drug dependence or abuse, if it is a primary diagnose and the mood disorder is due to his administration * patients that at the time of study entry or at any other time of study, need treatment with antiepileptics or other substances with potential effect as mood stabilizers (i,e new antiepileptics different to lithium, valproic acid and/or carbamazepine
mycophenolic acid pharmacokinetics and pharmacogenomics in lupus nephritis

Conditions: Lupus Nephritis

Summary: this study investigate mycophenic acid (mpa) pharmacokinetics and pharmacogenomics and their impact on the clinical outcomes in lupus nephritis (ln) patients. lupus nephritis patients (both active or inactive) will be recruited. mpa levels will be checked at 1, 2, 4, 8, 10, 12 hrs after mmf administration by an enzymatic assay upon recruitment, then at 6-months' intervals and also when clinically significant events occurred. the mpa levels will be correlated with clinical parameters and outcomes. pharmacogenomics studies will also be carried out and correlated with mpa exposure and clinical outcomes.

this study investigate mycophenic acid (mpa) pharmacokinetics and pharmacogenomics and their impact on the clinical outcomes in lupus nephritis (ln) patients. lupus nephritis patients (both active or inactive) will be recruited. mpa levels will be checked at 1, 2, 4, 8, 10, 12 hrs after mmf administration by an enzymatic assay upon recruitment, then at 6-months' intervals and also when clinically significant events occurred. the mpa levels will be correlated with clinical parameters and outcomes. for active patients, the mpa levels will be correlated with treatment response (cr or pr) and side effects. for patients in remission, the mpa levels will be correlated with drug tolerability and relapse. pharmacogenomics studies will also be carried out and correlated with mpa exposure and clinical outcomes.

Eligibility criteria:
inclusion criteria: 1. patients with recent active ln (biopsy-proven class iii/iv+/-v ln according to the isn/rps 2003 classifications within 3 months, with proteinuria \>0.5 g/day and/or active urinary sediments) who receive corticosteroids and mmf (1g bd for 6 months) as induction treatment. 2. ln patients in remission (defined as proteinuria \<0.5 g/day with inactive urinary sediment, prednisolone \<10 mg/day) and on stable mmf maintenance (dose unchanged within the previous 3 months). exclusion criteria: 1. patients who receive enteric-coated mycophenolic acid (myfortic). 2. patients who receive concomitant calcineurin inhibitors (e.g. cyclosporine or tacrolimus) other than corticosteroids and mmf. 3. patients who receive concomitant medications which affect the mpa pharmacokinetics such as cholestyramine, acyclovir, and rifampicin. 4. patients who are pregnant or lactating. 5. patients with gastric emptying disorders 6. patients with hepatic or biliary diseases

Keywords: lupus nephritis mycophenolic acid pharmacokinetics pharmacogenomics
lithium long covid dose-finding study

Conditions: Long COVID

Summary: this open-label study will assess if lithium dosages of 30-45mg/day are associated with greater symptomatic benefit than dosages of 10-15mg/day previously assessed among 50 patients with long covid.


Eligibility criteria:
inclusion criteria: 1. enrolled from november 2022-july 2023 in lithium long covid clinical trial at ub. 2. reports bothersome fatigue and/or brain fog while not taking lithium or, reports satisfactory benefit to these symptoms while taking lithium. 3. fatigue severity scale (fss) score ≥28 or brain fog severity scale (bfss) score ≥28 at baseline or; fss \<28, bfss \<28 and pgic at visit 1 of "much improved" or "very much improved" while taking lithium. 4. did not "respond" to placebo therapy, based on the responder analyses outlined in the preliminary data section above, defined as a ≥18-point reduction fss or ≥15-point reduction in bfss from baseline to the end-of-double-blind study phase while receiving placebo therapy. exclusion criteria: 1. fever or signs of acute infection in last 4 weeks. 2. covid vaccine administered within 4 weeks. no change in any psychoactive or steroid medications for ≥30 days. 3. plan to change a psychoactive, steroid or diuretic medication in next 5 weeks. 4. history of heart attack or stroke within the previous year. 5. active medical, psychiatric or social problem that would interfere with completing the study procedures in the opinion of the investigator. 6. daily nsaid use. 7. pregnant or nursing or planning to get pregnant over the next 11 weeks.
monitoring the hepatological toxicity of drugs (hepatox)

Conditions: Liver Diseases; Liver Dysfunction; Liver Failure; Hepatotoxicity

Summary: several drugs and chemotherapies seem to have an impact on the hepatological system. this study investigates reports of hepatological toxicities, including the international classification of disease icd-10 for treatments in the world health organization (who) global individual case safety report (icsr) database (vigibase).

several drugs and chemotherapies seem to have an impact on the hepatological system and are responsible of a wide range of hepatological diseases and side effects. those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. this study investigates the main characteristics of patients affected by rare hepatological side effects imputed to drugs. a causality assessment according to the who-umc (world health organization - uppsala monitoring center) is systematically applied.

Eligibility criteria:
inclusion criteria: * case reported in the who's pharmacovigilance database till 04/02/2019 exclusion criteria: * chronology not compatible between the drug and the toxicity

Keywords: hepatological disease hepatotoxicity chemotherapies drugs
validation of a magnetic sensor in arterial flow recording, compared with the reference method, at various peripheral arterial sites

Conditions: Lower Extremity Artery Disease

Summary: the measurement of magnetic fields emitted by cardiac activity has already been studied in magneto-cardiography. to date, however, this technology has never been evaluated in the peripheral circulation. the magnetic susceptibility of iron in the circulating blood and the ionic currents in the blood stream generate a very weak induced magnetic current, which can be detected by the micro-sensor of the prototype investigators wish to study. proving the validity of this prototype would make it a new diagnostic and even prognostic tool, non-invasive, less costly and more accessible than doppler for screening peripheral arterial disease.


Eligibility criteria:
inclusion criteria: * patients hospitalized in the heart-lung unit of the montpellier university hospital, for any reason whatsoever * patient with lower extremity artery disease (lead) (stage 1 to 4 according to leriche and fontaine) or not (absence of lead) * age ≥ 18 years exclusion criteria: * patient with a metal implant in the vicinity of the device's area of use * patient requiring additional hygiene precautions * subject not affiliated to a social security scheme or not benefiting from such a scheme. * pregnant or breast-feeding woman, patient unable to give consent, protected adult, vulnerable persons * subject deprived of liberty by judicial or administrative decision * patient refusing to give consent

Keywords: peripheral arterial disease arterial obstructive disease doppler ultrasound magnetic sensors;
biomarker study in patients with trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: investigators performed this study to investigate the expression levels inflammatory cytokine and neurotransmitters (calcitonin gene-related peptide (cgrp), substance p (sp), vasoactive intestinal peptide (vip), and β-endorphin) in peripheral blood of participants with primary trigeminal neuralgia (tn).

sudden and electrick shooting sensation of face is an important clinical feature of trigeminal neuralgia (tn). the severe and excruciating nature of pain intensity associated with tn can impair the physical and psychosocial well-being of the patient, however, pathophysiologic mechanism of tn still remains unclear. recentrly, there have been a few studies suggesting biomarker levels in the blood and csf level, however, further study is required to elucidate the action mechanism. up to 90% of patients can achieve pain reduction using medical therapy alone. however, 10% -15% of tn cases demonstrate a minimal response to medication with various side effects. radiofrequency thermocoagulation (rft) of the trigeminal ganglion is an alternative treatment option for patients who are poor candidates for microvascular decompression or show serious side effects to medication. recent study revealed that rft of the trigeminal ganglion resulted in barrow neurological institute (bni) pain scale i or ii in 71.7% of patients, with a median time to recurrence of 36 months. although patients experience significant pain relief after rft, it is uncertain whether inflammatory cytokine and neurocytokine (cgrp, substance p, vip) are reduced.

Eligibility criteria:
inclusion criteria: * tn patients with nrs more than 4 * tn patients who failed medical treatment * tn patients showing severe adverse reaction with medication exclusion criteria: * patients showing allergic reaction to local anesthetics * patients with coagulation abnormality

Keywords: trigeminal neuralgia cytokine neurotransmitter
a randomized controlled trial to evaluate the efficacy of acupuncture versus aromatherapy as treatments to lessen nausea, vomiting and anxiety associated with adriamycin and cytoxan

Conditions: Nausea; Vomiting; Anxiety

Summary: the overall goal of this study is to explore the effectiveness of using acupuncture versus aromatherapy, in conjunction with standard of care anti-emetics, to decrease chemotherapy induced nausea, vomiting, and anxiety in breast cancer patients undergoing adriamycin and cytoxan. this study also aims to determine if aromatherapy and anti-emetics is more effective than acupuncture and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving adriamycin and cytoxan and if acupuncture and anti-emetics is more effective than aromatherapy and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving adriamycin and cytoxan.


Eligibility criteria:
i) inclusion * at least 18 years of age on the day of signing informed consent * patient has a diagnosis of breast cancer * patient is planned to start adriamycin and cytoxan chemotherapy ii) exclusion * patients who are unable to adhere to the protocol or treatment schedule * patients who have a concurrent illness or take medication that induces nausea independent of chemotherapy * patients undergoing radiotherapy or hormone therapy during chemotherapy treatments * patients who have a sensitive and/or poor sense of smell * patients who are allergic to essential oils, specifically peppermint, ginger, and/or lavender * patients who are already using essential oils or acupuncture for symptom management and are unwilling to stop while participating in this study * patients who are afraid of or unwilling to receive acupuncture stimulation * patients who are allergic to stainless steel needles * thrombocytopenia (platelets \< 20,000) * patients who have received aromatherapy and/or acupuncture treatment within 1 week of starting treatment on this study
trial of effect of high-frequency transcranial magnetic stimulation in the management of borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: this study is going to evaluate the effects of repetitive transcranial magnetic stimulation (rtms) on borderline personality disorder patients symptoms.

there is a great body of literature about the positive effects of rtms therapy on various psychiatric disorders. in this study we are going to evaluate the effects of high-frequency rtms over the left dorsolateral prefrontal cortex (dlpfc)region in borderline personality disorder (bpd) patients. patients will be assessed by subjective measures for bpd.

Eligibility criteria:
inclusion criteria: * clinically diagnosed borderline personality disorder according to dsm iv. exclusion criteria: * epilepsy * any metal device * psychotic disorders * bipolar mood disorder type 1

Keywords: borderline personality disorder repetitive transcranial magnetic stimulation
use of huc-msc product (bx-u001) for the treatment of covid-19 with ards

Conditions: COVID-19; ARDS; Acute Respiratory Distress Syndrome

Summary: this is a phase 1/2a study including 2 parts, phase 1 and phase 2a. the phase 1 part is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of a human umbilical cord derived mesenchymal stem cell product (bx-u001) in severe covid-19 pneumonia patients with acute respiratory distress syndrome (ards). qualified subjects after the screening will be divided into low, medium, or high dose groups to receive a single intravenous infusion of bx-u001 at the dose of 0.5×10\^6, 1.0×10\^6, or 1.5×10\^6 cells/kg of body weight, respectively. the phase 2a part is a randomized, placebo-controlled, double-blind clinical trial examining the safety and biological effects of bx-u001 at the appropriate dose selected from phase 1 for severe covid-19 pneumonia patients with the same inclusion/exclusion criteria as the phase 1 part.


Eligibility criteria:
inclusion criteria: 1. male or female, aged between 18 and 80; 2. laboratory (rt-pcr, gene sequencing or antibody) confirmed cases of severe covid-19 pneumonia with mild to moderate ards (berlin definition); 3. patients are intubated; 4. patients who voluntarily adhere to the research procedures and ensure good compliance during the research period; 5. patients who fully understand the research nature of this study and sign written informed consent. exclusion criteria: 1. subjects who have received investigational drug (except for remdesivir) for the treatment of covid-19 within 30 days before screening; 2. subjects who are pregnant, breastfeeding or whose urinary pregnancy test is positive before participation in the study; subjects who are pregnant, breastfeeding, have a birth plan, or are unwillingness to use contraception during the study period and within 12 months of infusion; except for subjects who have sterilization surgery or menopause during the study period; 3. within 3 days before screening/randomization, subjects who have used high-dose corticosteroids that is equivalent to methylprednisolone \>240 mg/day or irregular use of systemic corticosteroids to treat other diseases that could affect the efficacy evaluated by the investigator; 4. subjects receiving extracorporeal membrane oxygenation (ecmo) support. 5. subjects who are allergic to low-molecular-weight heparin calcium or human albumin; 6. subjects with ongoing malignant tumors.