Kornimate/medical-research-clean huggingface dataset:
novel earpiece for transcutaneous auricular neurostimulation (tan) for symptoms of opioid withdrawal

Conditions: Opioid-use Disorder; Opioid Withdrawal

Summary: the objective of this study is to evaluate whether tan via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.

this study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment, and receive tan treatment and assessment every day during their 3 to 5-day detox treatment. use of opioid-based medication assisted therapy (mat) will not be permitted at any point during the study. use of non-opioid-based mats (i.e. comfort or rescue medications) will not be permitted until after the subject has completed the 60 minute cows assessment to ensure changes in cows score at 60 minutes are only the result of tan therapy.

Eligibility criteria:
inclusion criteria: * current opioid dependence; prescriptive or non-prescriptive * cows score is ≥ 13 or in the opinion of the investigator the subject is in moderate to severe withdrawal * 18-65 years of age * english proficiency * participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements exclusion criteria: * current evidence of an uncontrolled and/or clinically significant medical condition * history of seizures or epilepsy * history of neurological diseases or traumatic brain injury * participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment * recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation * presence of devices (e.g., pacemakers, cochlear prosthesis, neurostimulators) * abnormal ear anatomy or ear infection present * women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for the duration of the study * females who are pregnant or lactating * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Keywords: auricular neurostimulation vagus nerve stimulation transcutaneous withdrawal symptoms
afterload mismatch predictive modle for transcatheter edge-to-edge repair (ample-teer)

Conditions: Mitral Insufficiency

Summary: mitral regurgitation (mr) is one of the most common valvular heart diseases in china, causing heart failure. patients with moderate to severe mr have a very poor clinical prognosis if no intervention is performed. when symptoms are still poorly controlled after guideline-directed medical therapy (gdmt) or when surgical intervention is not suitable, transcatheter mitral valve edge-to-edge repair (teer) can improve the patient's quality of life and reduce the hospitalization rate and mortality rate. however, some patients develop into afterload mismatch (am) after teer, persistent adverse ventricular remodeling, and a high mortality rate, which limits the surgical benefits of teer surgery in these mr patients. therefore, how to scientifically predict am and intervene as early as possible has become a research hotspot for optimizing the postoperative management of teer patients. afterload mismatch predictive modle for transcatheter edge-to-edge repair (ample-teer) study is a prospective cohort study including adult patients undergoing teer during hospitalization. we aim to evaluate whether the patients develop into am after teer, evaluate the prognostic risk factors of am and construct a prognostic clinical model to guide clinical decision-making.


Eligibility criteria:
inclusion criteria: * patients undergoing transcatheter mitral valve edge-to-edge repair (teer) during hospitalization. * aged over 18 yrs. exclusion criteria: * patients unable to provide written consent.
transitional care program to improve risk factors in stroke survivors

Conditions: Stroke, Ischemic

Summary: the goal of this clinical trial is to evaluate whether our transitional care program helps stroke survivors better manage their risk factors for stroke to lower the risk of a repeat stroke. the main question it aims to answer is: - does the program help participants meet the targets set by the american heart association clinical guidelines for control of risk factors associated with stroke? researchers will compare participants enrolled right after being discharged from the hospital to participants enrolled around 3-5 months after being discharged to examine whether timing differences in enrollment affect the efficacy of the program. participants will: * keep track of their medications, their exercise, and their health information using smart devices provided by the study * answer questions about their health and lifestyle * meet with our team of healthcare providers


Eligibility criteria:
inclusion criteria: all cohorts: * age 30 or above * evidence of ischemic stroke documented on ct or mri * modified rankin score of 3 or less early enrollment: * admission for ischemic stroke at a participating site * enrolled during their admission for ischemic stroke or within 24 hours of discharge late enrollment: * stroke survivors previously admitted at the participating sites' inpatient stroke unit * enrollment date between 1 and 6 months after discharge for inpatient admission for ischemic stroke exclusion criteria: * participants determined to have hemorrhagic or periprocedural stroke based on hospital emr review will be excluded. * participants determined to have an ischemic stroke due to dissection based on hospital emr review will be excluded. * participants who lack capacity determined by the care team during their hospitalization (for the early enrollment group) or their most recent clinical encounter (for the late enrollment group) will be excluded. * participants with a diagnosis of dementia will be excluded. * participants with acute subdural hemorrhage will be excluded. * participants with hemorrhagic stroke due to vascular abnormality (aneurysm or avm) or trauma will be excluded. * participants who cannot perform the following will be excluded: 1. offer a consistent choice about participating in the study 2. demonstrate that they can comprehend and recall major features of the study including: participation is voluntary, the major procedures, the primary risk, and the primary benefit. * participants who are discharged to long-term acute care hospitals will be excluded. * participants who are unable to read or communicate fluently in english will be excluded. * participants who do not have reliable internet access to complete telemedicine visits per self-report will be excluded. * participants already enrolled in another clinical study which could impact the frequency of monitoring or care that participant receives. * participants who do not reside in virginia, west virginia, tennessee, oklahoma, illinois, or michigan will be excluded.

Keywords: transitional care program secondary stroke prevention stroke care
change in nlr and survival among advanced lung cancer patients receiving icis with immunomodulator

Conditions: Advanced Lung Cancer

Summary: the main objective of this study is to evaluate the change of neutrophil to lymphocyte ratio (nlr) after 6-week treatment of immune checkpoint inhibitors (icis) with or without immunomodulatory drugs and recognize the effect of post-treatment nlr and overall survival in advanced lung cancer patients by retrospective review.

in recent years, the therapeutic strategies for lung cancer have been enriched with small molecular targeted therapy and immunotherapy. in this retrospective study, we will observe the change in nlr and explore its possible association with survival among advanced lung cancer patients receiving immune checkpoint inhibitors (icis) with and without such immuno-modulator, astragalus polysaccharide injection. it can be used to understand the relationship between nlr values and the survival rate of lung cancer patients after icis treatment. physicians can refer to this result to give patients the suitable treatment recommendations.

Eligibility criteria:
inclusion criteria * aged 20 years and older. * patients who have been given a diagnosis of lung cancer. * previously advanced lung cancer patients first treated with icis from oct 1, 2015 to oct 31, 2019. exclusion criteria * patients who have no hematological laboratory data available at baseline (within 3 days prior to ici treatment) and the 6th week (± 2 weeks) after ici treatment initiation.

Keywords: neutrophil to lymphocyte ratio (nlr) immunomodulator
a study of qls31905 combination chemotherapy as first-line treatment in patients with advanced solid tumors

Conditions: Solid Tumor

Summary: this study aims to evaluate the efficacy and safety of qls31905 plus chemotherapy in patients with claudin18.2-positive advanced solid tumors.


Eligibility criteria:
inclusion criteria: * subjects voluntarily participate in the study and sign the informed consent form; * eastern cooperative oncology group (ecog) performance status score of 0-1; * expected survival time ≥ 3 months; * histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors; * no prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease; * tumor tissue samples determined to have moderate-to-high claudin18.2 expression by immunohistochemistry (ihc); * at least one measurable lesion per recist v1.1; * patients with adequate cardiac, liver, renal function, etc. exclusion criteria: * history of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ; * underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study; * known central nervous system metastases; * patients with hepatitis b; patients with hepatitis c; patients who test positive for syphilis, or patients with a known history of hiv or positive hiv screening test; * patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse; * patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.

Keywords: cldn18.2 qls31905
comparative effectiveness of cystine versus nicotine replacement therapy

Conditions: Nicotine Addiction

Summary: a pragmatic, single blinded, randomized, controlled non-inferiority trial of cytisine versus nicotine replacement therapy for continuous abstinence is conducted in the government run primary health hospitals in mongolia.

rationale: in mongolia, smoking cessation assistance in the governmental health sector consists of behavioral counseling and a 3-week regimen of the nrt patch that costs 175 usd. this cost for low income adults limits effectiveness. a 2014 study documented the superiority and lower cost (\<20 usd) of cytisine versus nrt for continuous abstinence. trial investigators are testing the comparative effectiveness of cytisine in the "real life setting" of their national health care system and, if proven effective, will include coverage for cytisine in the national health plan. research question/objective: to determine whether a 25 day course of cytisine tablets is at least as effective as 25 days of nrt in helping smokers remain abstinent for at least one month. design: a pragmatic, single blinded, randomized, controlled non-inferiority trial. setting: six governmental primary care centers in ulaanbaatar, mongolia, and outskirts. participants: mongolian adult smokers referred to government-run addiction units. intervention and procedures: participants are randomized to 5 weeks of treatment (n=654) or usual care (n=653) and a 6-month follow-up. the treatment consists of a 25-day course of cytisine tablets and behavioral counseling. usual care consists of 25 days of nrt and behavioral counseling. measurements: the primary outcome is continuous abstinence (\< 5 cigarettes smoked since quit date) at 1 month. secondary outcomes include 7-day point prevalence abstinence rates and adverse events.

Eligibility criteria:
inclusion criteria: * seeking smoking cessation treatment * ages 18 years or older * currently smoking \> 5 cigarettes per day * willingness to make quit attempt with pharmacotherapy * able to provide verbal and written informed consent * have telephone access exclusion criteria: * pregnancy or currently breastfeeding * current users of nrt (patch, gum, lozenge) * current users of non_nrt smoking cessation pharmacotherapy * enrolled in another smoking cessation program (non-governmental) * clinical disorder that contraindicates use of nrt or cytisine (heart attack, stroke, severe angina within the past 2 weeks, uncontrolled hypertension, phaeochromocytoma, severe mental illness)

Keywords: smoking cessation, nicotine replacement therapy, cytisine
connectomics in psychiatric classification

Conditions: Dementia; Dementia Alzheimers; Frontotemporal Dementia; Pick's Disease With Dementia

Summary: washington university early recognition center is conducting a research study to examine brain functional connectivity and network patterns in participants with dementia.

this study extends the assessment of brain connectivity and function, being conducted in the human connectome project (hcp), to psychiatrically ill populations. the hcp consortium has made significant improvements in mri instrumentation, data acquisition, preprocessing, and analysis. these improvements are currently providing publicly available data on the structure, function, and connectivity of young adult human (age 22-35) brains at unprecedented spatial resolution, temporal resolution, and accuracy. this study will focus on individuals aged 45-85 years who have a diagnosis of dementia, or are healthy controls. additionally, similar to the hcp, the investigator will study the effect of genetics on the patterns of brain connectivity in various psychiatric populations. dna will be collected non-invasively from saliva. furthermore, this investigator will study cortisol levels in hair samples as an additional assessment to help characterize brain imagining findings.

Eligibility criteria:
inclusion criteria: * ages 45-85 * has consented to participate or has an lar present that has consented to participate * dsm-5 diagnosis of dementia exclusion criteria: * any genetic disorder, such as cystic fibrosis or sickle cell disease * multiple sclerosis * cerebral palsy * loss of consciousness for \>30 minutes * pregnancy * hospitalization for stroke, brain aneurysm, brain hemorrhage, or subdural hematoma
prevalence study : elderly patients and rehabilitation in icu. impact of frailty.

Conditions: Resuscitation

Summary: study design. the study fragirea is a multicentric prevalence study on the frequency of frailty among elderly patients and the quality of management. the voluntary icus will have to include all patients ≥ 70 years on a limited period (1 month) or until the number of 15 inclusions is reached. the frailty is going to be evaluated by a frailty score adapted to the icu, based on informations given by the patient's family. it is a descriptive non-interventional study, aiming at the description of frequency of frailty and management of the patient in order to set-up a prospective future study on the potential role of early rehabilitation of ageing patients in icus.


Eligibility criteria:
inclusion criteria: * ≥ 70 year-old * prevision of a length of stay \> 24 hrs. * patient or relative who received information about the study and did not oppose it exclusion criteria: * life expectancy \< 24 hrs * patients unable to communicate and no next of kin available. * adults, non-emancipated minors, persons unable to receive information, * persons placed under the safeguard of justice, * subject participating in another search including an exclusion period still in progress at pre-inclusion

Keywords: resuscitation frailty icu ageing rehabilitation elderly
bi 695501 versus humira in patients with active crohn's disease: a trial comparing efficacy, endoscopic improvement, safety, and immunogenicity

Conditions: Crohn Disease

Summary: primary objective: the primary objective of this trial is to compare the clinical efficacy of bi 695501 with eu-approved humira® in patients with active crohn's disease (cd). secondary objectives: the secondary objectives of this trial are to compare the efficacy and safety of bi 695501 with eu-approved humira® across the induction and maintenance phases.


Eligibility criteria:
inclusion criteria: * males and females aged \>=18 and =\<80 years at screening who have a diagnosis of moderate to severely active crohn's disease (cd), confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. patients must have all of the following: * crohn's disease activity index (cdai) score of \>=220 and =\<450 * a diagnosis of crohn's disease (cd) confirmed by ileocolonoscopy during screening * presence of mucosal ulcers in at least one segment of the ileum or colon and a ses-cd score ≥7 (for patients with isolated ileal disease ses-cd score ≥4), as assessed by ileocolonoscopy and confirmed by central independent reviewer(s) before randomization * anti-tumor necrosis factor (tnf) patients or patients previously treated with infliximab who had initially responded and who meet one of the following criteria: * responded and developed secondary resistance due confirmed anti-infliximab anti-drug antibody formation, which caused infliximab depletion * responded and became intolerant * further inclusion criteria apply exclusion criteria: * patients with ulcerative colitis or indeterminate colitis * patients with symptomatic known obstructive strictures * surgical bowel resection performed within 6 months prior to screening or planned resection at any time while enrolled in the trial * patients with an ostomy or ileoanal pouch * patients with short bowel syndrome * patients who have previously used infliximab and have never clinically responded * patients who have previously received treatment with adalimumab, or who have participated in an adalimumab or adalimumab biosimilar clinical trial * further exclusion criteria apply
effects of renal sympathetic denervation on the cardiac and renal functions in patients with drug-resistant hypertension through mri evaluation

Conditions: Uncontrolled Hypertension

Summary: this is a prospective, single centre clinical investigation looking at short (6 months) and long term (24 months) changes in cardiac function and renal function in patients with drug-resistant hypertension post renal sympathetic denervation.


Eligibility criteria:
inclusion criteria: * subject must be able and willing to comply with the required follow-up schedule * therapeutic goods association approved indications for enlightn™ renal denervation system * subject is ≥ 18 years of age at time of consent subject has office sbp ≥ 160 mmhg (except for subjects with diabetes mellitus who must demonstrate an office sbp of ≥ 150 mm hg) within 14 days of the procedure ◦subject is taking ≥ 3 antihypertensive medications concurrently at maximum tolerated dose (this must include one diuretic) or subject has a documented intolerance to at least 2 out of the 4 major classes of anti-hypertensives (ace/arb, ccb, diuretics, beta blockers and is unable to take 3 antihypertensive drugs. exclusion criteria: * standard cmr exclusions; * implanted cardiac device * intracranial metallic implants * claustrophobia -gadolinium-specific: estimated gfr \<60 mls/min (usual clinical cut-off is \<30 mls/min). * adenosine-specific: * asthma / reactive airways disease * \>first degree atrioventricular block * concomitant use of dipyridamole or theophylline consumption of caffeine within 48 hours of proposed investigation * enlightn™ renal denervation system exclusion criteria: subject has an identified cause of secondary hypertension * subject has an estimated gfr \<45 ml/min per 1.73 m2 using the mdrd formula * subject has undergone prior renal angioplasty, indwelling renal stents, and/or aortic stent grafts * subject has haemodynamically significant valvular heart disease * subject has a life expectancy less than 12 months, as determined by the pi * subject is participating in another clinical study subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods * subject has renal arteries with diameter(s) \< 4 mm in diameter

Keywords: uncontrolled hypertension renal denervation renal artery
ppar-gamma: a novel therapeutic target for asthma?

Conditions: Asthma

Summary: to test the hypothesis that stimulation of ppar-γ receptors has a therapeutic role in the treatment of asthma.


Eligibility criteria:
inclusion criteria: * age 18-75 of either sex with a clinical diagnosis of asthma, * fev1 ≥ 60% predicted and an increase in fev1 of greater than 12% following inhaled salbutamol 400μg or peak expiratory flow (pef) variability \>12% during run-in. * allowed medication: 0-800μg inhaled beclomethasone diproprionate or equivalent and as required short acting beta agonist. exclusion criteria: * current smoking, * \> 10 pack years smoking history, * treatment with leukotriene antagonists, * liver or cardiovascular disease, * oral steroid treatment or exacerbation within 6 weeks, * females who are pregnant, lactating or not using adequate contraception, * any contra-indication to pioglitazone (hypersensitivity to pioglitazone, cardiac failure, history of cardiac failure, hepatic impairment, diabetic ketoacidosis), * oral or insulin treatment for diabetes, * treatment with gemfibrozil or rifampicin.
disability-adjusted life years in a senegalese cohort of patients with subarachnoid hemorrhage

Conditions: Disability Adjusted Life Years of Sub-arachnoid Hemorrhage in Senegalese Cohort

Summary: subarachnoid hemorrhage (sah) is the extravasation of blood into the subarachnoid space from traumatic or nontraumatic origin. there is a paucity of data on the burden of sah in african countries. in this study, we analyzed data from patients in the largest neurovascular center in senegal to determine the sex- and age-adjusted burden of sah in senegal.

the fann teaching hospital (dakar, senegal) institutional review board authorized this study. consent was obtained from adult patients and the parents/legal guardians of children. patient data were stored in a password-protected excel spreadsheet, and this spreadsheet was stored on a hard drive. only the authors had access to the data.

Eligibility criteria:
inclusion criteria: * sub-arachnoid hemorrhage admission exclusion criteria: * not admitted for sub-arachnoid hemorrhage
skeletal muscle contractility, self-reported pain and tissue sensitivity in females with neck/shoulder pain and trapezius mftrps

Conditions: Myofascial Pain Syndrome

Summary: in relation to myofascial triggerpoints (mftrps) of the upper trapezius, this study will explore muscle contractility characteristics, the occurrence of post-intervention muscle soreness and the effect of dry needling on muscle contractile characteristics and clinical outcomes.


Eligibility criteria:
inclusion criteria: * a clinically relevant mftrp of the upper trapezius musculature * self-reported pain of ≥3 on an eleven-point numerical pain rating scale (nrs-101). * bmi less than 31 exclusion criteria: * a history of chronic, systemic pathology (e.g. hemophilia) * pre-existing neck/shoulder pathology/surgical procedures, * clinical depression * health-related legal action * pregnant * anti-inflammatory and/or chronic pain medication * had received dry needling for a shoulder/neck disorder within 6 months prior to the study (to raise the level of patient naiveté) suffered from needle phobia

Keywords: tp myofascial pain