Kornimate/medical-research-clean huggingface dataset:
detection of heart rhythm and bp with rhythmpadbp

Conditions: Atrial Fibrillation

Summary: this study will assess a new device, the rhythmpadbp, which detects heart rhythm and measure blood pressure simply by placing palms of the hands on a pad containing titanium electrodes.

normally the way a doctor will assess the rhythm of the heart involves asking for an electrocardiogram (ecg) which involves having to remove clothing, and sometimes shaving hair. 10 different leads are attached to stickers that are placed on the chest, and other parts of the body. this is known as a 12-lead ecg and is the standard way that heart-rhythm problems are first investigated. the usual method of measuring blood pressure (bp) involves wrapping a cuff around the arm and inflating it to enough to measure the bp. the reading is then displayed on a monitor. this can sometimes be uncomfortable and is often time consuming, particularly in busy clinical settings. recent advances in technology however have given us different ways of gaining some of the same information given by a 12 lead ecg and the standard bp apparatus, using much easier to use devices. one of these devices is the rhythmpadbp system by cardiocity tm. this is a device where participants can record the underlying heart rhythm and bp readings simply by placing palms of both hands on the device. this device does not require removal of clothing or placing a bp cuff around arm and so the readings can be gained more rapidly and with greater convenience. investigators propose to test this device to assess how accurately it recognises the most common cardiac rhythm disturbances, e.g. atrial fibrillation (af), and also measures the blood pressure. this will help to identify af and any difference of bp in both arms. af is an independent risk factor for stroke and increases the risk of stroke by five-fold. a discrepancy of bp in both arms can be a sign of blood vessel disease and is linked to increased risk of cardiovascular and cerebrovascular disease. if investigators find that this device is correctly recording af and bp, it may give us another simpler way of diagnosing af and bp discrepancies on both sides.

Eligibility criteria:
inclusion criteria: 1. age greater or equal to 18 years 2. able to consent 3. no known allergies to the metal or any component used in the rhythmpadbp exclusion criteria: 1. age less than 18 years 2. not able to consent 3. allergies to the metal or any component of the rhythmpadbp device 4. active skin conditions affecting the hands, i.e. burns, infections 5. in-situ cardiac devices i.e. pacemaker or a defibrillator that could interfere with the ecg recording.
neural alteration response to transcutaneous auricular vagus nerve stimulation (tavns) in depressed patients

Conditions: Depression

Summary: electrical vagus nerve stimulation (vns) was approved by fda for treatment of chronic recurrent depression in 2005. recently, non-invasive, transcutaneous auricular vagus nerve stimulation （tavns） has already been used for depression treatment. however, the neural mechanism remains unclear, and the relationship between stimulation parameters and neural response were also unknown. the present study aims to investigate the specific brain activation in depression patients after tavns，compared with healthy controls.


Eligibility criteria:
inclusion criteria: * meets icd-10 diagnosis standard; * without taking anti-depressive medication or other psychiatric medications 2 weeks before the experiment; * patient has exhibited symptoms for at least 2 months, but no longer than 2 years. exclusion criteria: * with current addiction to drugs; * with other severe organic diseases, such as severe heart disease, kidney failure etc; * disagree with the consent form. * cannot receive mri scan.
rollover study of cenicriviroc for the treatment of liver fibrosis in participants with nonalcoholic steatohepatitis

Conditions: Nonalcoholic Steatohepatitis; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease

Summary: this rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in either the centaur study 652-2-203 \[nct02217475\] or the aurora study \[nct03028740\].


Eligibility criteria:
inclusion criteria: * successful completion of both treatment period 1 and treatment period 2, of the centaur study (652-2-203), including a year 2 liver biopsy. * completed the aurora study (3152-301-002) as a result of reaching an adjudicated liver-related clinical outcome in part 1 or part 2 of the study of: * histopathological progression to cirrhosis * model for end-stage liver disease (meld) score ≥ 15 * ascites (requiring intervention, ie, large volume paracentesis ≥ 1l or initiation of a diuretic) * hospitalization (as defined by a stay of ≥ 24 hours) for onset of variceal bleed, hepatic encephalopathy (defined by a west haven stage of ≥ 2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis with positive ascitic fluid bacterial culture). exclusion criteria: * prior or planned liver transplantation * other know causes of chronic liver disease such as: alcoholic liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, wilson's disease, hemochromatosis, or iron overload, or alpha-1 antitrypsin (a1at) deficiency.
safety of antiepileptic withdrawal in long term video-eeg monitoring

Conditions: Epilepsy

Summary: save is a stratified cluster-randomised controlled, parallel group, open-label trial, with epileptic monitoring unit (emu) as the units of randomisation and patients as the unit of analysis. the focus of research is the management of antiepileptic drugs (aeds) withdrawal during long term video eeg (veeg) monitoring in patients with drug resistant seizures. this non-standardised medical practice, which aims at promoting the occurrence of seizures during the time limit of the monitoring period, exposes patients to significant risks which should be minimised by harmonisation of practice and a standardised protocol of aeds withdrawal. save will assess the impact of a standardised protocol of aeds withdrawal during long-term veeg monitoring on the frequency of seizure-related serious adverse events occurring during these monitorings and on the ability to obtain veeg recording of seizures within appropriate time limits. 10 of the 22 emus will be randomised to the group where the standardised protocol of aeds withdrawal will be used systematically, while the other ten emus will continue their current non-standardised practice of aeds withdrawal, and will serve as a control group. the setting of the study will include a 6 months evaluation phase, prior to randomisation, during which the organisational characteristics, baseline emus' activity, current management of aeds withdrawal, and rate of serious adverse events (saes) of each participating center will be evaluated. the standardised study protocol of aeds withdrawal has been defined on the basis of a systematic review of all relevant publications in the field.


Eligibility criteria:
inclusion criteria: * male or female suffering from drug-resistant epilepsy * age ≥ 6 years old * inpatient in one of the participating emus for recording seizure during long-term veeg monitoring (≥ 48 hours) * patient who gave its written informed consent to participate to the study, or for children, whose minimum one of parents had given its written informed consent exclusion criteria: * age \< 6 years old * inpatient in one of the participating emus for performing short-term veeg monitoring (\<48 hours) * pregnant or breastfeeding woman

Keywords: withdrawal of antiepileptic drugs monitoring veeg safety adverse event standardized protocol
an explorative trial evaluating the effect of leo 32731 cream in adults with mild to moderate atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: the aim of this trial is to assess the efficacy of leo 32731 cream 20 mg/g compared with leo 32731 cream vehicle in adults with mild to moderate ad after 3 weeks of treatment.


Eligibility criteria:
inclusion criteria: * following verbal and written information about the trial, subjects must provide informed consent documented by signing the informed consent form (icf) prior to any trial related procedures being carried out * subject with atopic dermatitis (ad) as defined by hanifin and rajka criteria and with mild to moderate disease severity (iga 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1) * two symmetrically located and comparable entire treatment areas (etas) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete ad lesion or part of an ad lesion); total sign score (tss) of at least 5 on both etas; difference in tss not greater than 2 between the two etas; sign score for erythema ≥ 2 on both etas; difference in investigator´s treatment area assessment of disease severity not greater than 1 between the 2 etas exclusion criteria: * any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than atopic dermatitis), sunburn, hyper- or hypopigmentation, scars
photodynamic therapy compared to adapalene 0.1% gel plus doxycycline in the treatment of acne vulgaris

Conditions: Acne

Summary: * acne vulgaris is a common inflammatory skin disease that affects more than 85% of teens and some people may continue throughout adulthood. * topical retinoids related to oral antibiotics are considered first-line treatment of moderate inflammatory acne. * recently, photodynamic therapy (pdt) with a photosensitizer, 5-aminolevulinic acid (ala) or methyl aminolevulinate (mal), has proven useful in the management of inflammatory acne. although progress has been made in the study of photodynamic therapy for acne, to date, no study has compared pdt with standard and well-validated pharmaceutical treatments and with the current recommended therapy for most types of acne combination therapy with a topical retinoid plus one or more antimicrobial agents. hypothesis * pdt with the photosensitizer ala will be effective and safe for the treatment of moderate facial inflammatory acne. * the ala-pdt is more effective than conventional therapy with oral antibiotics and topical retinoids in the treatment of moderate inflammatory acne with faster action at 12 weeks of follow-up.

* there will be a randomized, controlled, single blind comparison study of pdt with 5-aminolevulinic acid (ala) 20% versus conventional therapy consisting of topical 0.1% adapalene plus doxycycline 100 mg/day orally in patients with moderate inflammatory acne. * be sought from all patients written informed consent prior to study entry. * for sample size calculation, we assumed that the correlation is the same in both groups and is relatively low (0.01), the number of lesions per subject is equal in both groups with a mean of 100 and low variance, which take 1 control per case and that. whereas the percentage of improvement in the control group is 0.6 and expected in the treatment group is 0.7 yields a sample size of 23 patients in the treatment group and 23 new controls. interventions: patients will be randomized to receive: 1. ala-pdt: in 23 patients applied 20% ala solution in the affected area for 1.5 hours. subsequently irradiated with noncoherent red light (lamp waldmann pdt 1200; wavelength 590-700 nm) with irradiance of 70 mw/cm2 and total dose or fluence of 37 j/cm2 for 7-9 minutes. from the sixth week will begin nightly topical adapalene 0.1% gel. 2. standard therapy: in 23 patients applied topical adapalene 0.1% gel at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.

Eligibility criteria:
inclusion criteria: * men and women between 18 and 30 years of age with moderate inflammatory acne exclusion criteria: * those who have received any treatment for acne either topic in the last 3 months before and systemic (including aco started) in the last 6 months of the study. * patients who are pregnant or breastfeeding. * patients with history of photosensitivity or autoimmune disease. * patients with a history or active tb disease or hiv. * patient refusal to participate in the study.

Keywords: acne moderate photodynamic therapy topical retinoids antimicrobial agents
veteran primers for crc screening

Conditions: Colorectal Cancer

Summary: this is a prospective, randomized controlled trial that will evaluate the effectiveness of primer postcards sent two weeks prior to the mailing of a fit kit in improving adherence to annual crc screening. this project is for the purpose of quality improvement and has been designated as non-research by the vha office of primary care, improvement \& innovation (vha program guide 1200.21).

veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 4 and 8) to the following interventions: 1. active arm: primer 1. intervention type: other 2. intervention description: mailed postcard notifying veteran of upcoming fit kit receipt for annual crc screening 2. control arm: no primer a. intervention type: no intervention randomization will be stratified within arms by prior screening status (prior screener vs. never screener) our primary outcome of interest is the return rate at three months post randomization. our secondary outcome of interest is the return rate at six months post randomization. enrollment in the trial will occur between may 1, 2021 and january 1, 2022.

Eligibility criteria:
eligible participants are automatically enrolled in this project. we are unable to enroll participants upon request. inclusion criteria: * veteran * assigned to a primary care provider at the va puget sound as of january 1, 2021 * at least 1 year of prior data available (evidence of at least one outpatient visit) * due for annual colorectal (crc) screening exclusion criteria: * not scheduled for either a screening or diagnostic colonoscopy within the 12 weeks from assessment. * not currently receiving hospice care * no record of recent death in the administrative data. * no history of crc or history of prior colectomy.

Keywords: cancer screening behavioral economics adherence
evaluation of the efficacy of preoperative ketamine nebulization on postoperative sore throat due to tracheal intubation for adult patients under general anesthesia, a prospective randomized controlled study

Conditions: Post Operative Sore Throat

Summary: sore throat includes specific symptoms such as dysphagia, dysphonia, hoarseness, continuous throat pain, and pharyngeal dryness. patients rated postoperative sore throat (post) as the eighth most undesirable outcome in the postoperative period post has a reported incidence of up to 62% following general anesthesia (ga). the incidence of post is more common in ga with tracheal intubation than in ga with the supraglottic airway ketamine is an n-methyl-d-aspartate (nmda) receptor antagonist and has been used as a gargle for reducing the incidence and severity of post due to its anti-nociceptive and anti-inflammatory effects


Eligibility criteria:
inclusion criteria: 1. age 16-60 years. 2. of both sex. 3. american society of anesthesiologists physical status (asa ps) i-ii. 4. undergoing general anesthesia with endotracheal intubation with surgery duration less than two hours. exclusion criteria: * a- history of chronic obstructive history of sore throat or upper respiratory tract infection. b- intraoral and intrapharyngeal surgery. c- airway disease or asthma. d- mallampati grade more than ii. e- known allergic to study drug. f- more than one attempt is required for intubation. g- hypertensive patients. h- epileptic patients. i- cerebral palsy or any neurological disorders. j- psychiatry patients. k- cardiac patients. l- perioperative use of anti-inflammatory drugs (non-steroidal anti-inflammatory drug or steroids).
the effect of intravitreal ranibizumab on visual acuity and hard exudate resolution in the treatment of diabetic macular edema with center involved edema and lipid exudates

Conditions: Diabetic Macular Edema; Hard Lipid Exudates

Summary: this is an open-label, phase i/ii study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.

this is an open-label, phase i/ii study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield. consented, enrolled subjects will receive multiple open-label intravitreal injections on 0.3mg ranibizumab administered every 30 days for 12 months per the treatment algorithm. the patients will be randomized to 1 of 2 treatment groups. group 1: treatment algorithm based on the diabetic retinopathy clinical research (drcr) protocol i 4:2:7 strategy based on the presence of macular edema. group 2: continue treatment until not only the macular edema is resolved but also until the lipid exudate is resolved. sample size: 30 eyes follow-up schedule: every 4 weeks throughout the study.

Eligibility criteria:
subjects will be eligible if the following criteria are met: inclusion criteria * ability to provide written informed consent and comply with study assessments for the full duration of the study * age ≥ 18 years * type 1 or type 2 diabetes mellitus * best corrected etdrs visual acuity (20/32-20/320) or letter score 78 to 24 * diabetic macular edema on clinical examination involving the center of the macula assessed to be the main cause of visual loss * retinal thickness measured on spectral domain optical coherence tomography (oct). zeiss cirrus: ≥290μm in women and ≥305 μm in men in the central subfield. heidelberg spectralis: ≥305μm in women and ≥320 μm in men in the central subfield * lipid exudates involving the central subfield on spectral domain oct. exclusion criteria subjects who meet any of the following criteria will be excluded from this study: * treatment for diabetic macular edema within the prior 4 months. * panretinal photocoagulation within the prior 4 months or anticipated need for panretinal photocoagulation within the next 6 months * major ocular surgery within the prior 4 months * myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack, or treatment for acute congestive heart failure occurred within 4 months before randomization * pregnancy (positive pregnancy test) or lactation * premenopausal women not using adequate contraception. the following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (iud), or contraceptive hormone implant or patch. * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * participation in another simultaneous medical investigation or trial
efficacy of the use of refrigerant helmet to prevent alopecia in patients treated with eribulin for breast cancer

Conditions: Breast Cancer; Metastatic Breast Cancer

Summary: halacap-1406 is a prospective single-centre non-interventional study assessing the refrigerant helmet use as medical device to prevent alopecia induced by eribulin (halaven®) in the conditions of use specified in its marketing authorization. eribulin will be used alone for the treatment of the patients having a locally advanced or metastatic breast cancer which have progressed after at least 1 chemotherapy regimen for their advanced stage.

a nurse will meet the patient and present the study, then the patient will be invited to participate. if the patient is interested, an information note will be given and the non-opposition of the patient will be collected. patients will be registered via a registration form and an inclusion number will be attributed at each patient. eribulin will be used within the framework of its marketing authorization, per cycle of 21 days, at day 1 and day 8. modalities of refrigerant helmet use will be set according to the habits of the oscar lambret center with the following rules : * placement of a single-use non-woven hygiene cap on the scalp * t-15 minutes: placement of the refrigerant helmet * t0: begin of eribulin infusion (duration: 2-5 minutes) * t+15 minutes: rinse of the line * t+30 minutes: withdrawal of the helmet efficacy will be evaluated before treatment and at each eribulin cycle.

Eligibility criteria:
inclusion criteria: * female patient who has a locally advanced or metastatic breast cancer * indication of halaven treatment : patient pretreated with anthracyclines or taxanes, patient who has received at least 1 chemotherapy regimen for their advanced or metastatic stage * patient who has had enough time to have retrieved her hair or whose last chemotherapy regimen didn't induce alopecia. * aged ≥ 18 years * non-opposition of the patient must have been collected exclusion criteria: * skin metastasis of the scalp * sensitivity to cold, cold agglutinin disease or cryoglobulinemia * impossibility to submit at the study procedures due to geographic, social or mental reasons

Keywords: locally advanced breast cancer alopecia eribulin
efficacy of transdermal fentanyl for chronic neuropathic pain

Conditions: Peripheral Neuropathy; Complex Regional Pain Syndromes (CRPS)

Summary: the efficacy of fentanyl tts for the treatment of neuropathic pain remains to be established, although opioids in general are clearly effective for neuropathic pain and fentanyl tts has been shown to be effective for treating other types of pain. we propose to measure functional outcomes, pain relief and side effects of fentanyl tts for the treatment of neuropathic pain. measures will be made at baseline and after titrating the drug to an effective level.


Eligibility criteria:
inclusion criteria: * age \>18 years * neuropathic pain persisting for \> 3 months * pain over the immediate previous three months * the average of the least and usual pain intensity rating of 3 or greater (0-10 numerical rating scale) during the last week prior to enrollment exclusion criteria: * a history of substance abuse * allergic reaction to an opioid * significant pain of alternate etiology other than the neuropathic pain state * severe pulmonary disease * recent myocardial infarction (within the preceding three months) * pregnancy * dementia * encephalopathy * those with life expectancy of less than six months and hiv seropositivity.

Keywords: neuropathic pain efficacy