Kornimate/medical-research-clean huggingface dataset:
measuring blood flow in the brain after epileptic activity

Conditions: Epilepsy; Depression; Postictal Delirium; Electroconvulsive Therapy

Summary: in this clinical trial, postictal phenomena (i.e., headache, delirium) will be investigated after administration of acetaminophen and nimodipine in depressed patients receiving electroconvulsive therapy (ect). postictal phenomena are thought to result from decreased cerebral blood flow and decreased oxygen concentration in the brain. it is expected that acetaminophen and nimodipine will reduce these postictal phenomena, compared to no treatment, because they target these mechanisms.

postictal phenomena, such as sensory, motor or memory deficits, headache, delirium, and psychosis, are common manifestations after electroconvulsive therapy (ect) induced seizures. also, postictal phenomena add to the burden of seizures in patients with epilepsy. the pathophysiology of these phenomena is poorly understood and effective treatments are not available (fisher rs, 2000; krauss \& theodore, 2010). recently, seizure-induced postictal vasoconstriction with cerebral hypoperfusion was observed in experimentally induced seizures in rats. treatment with acetaminophen or calcium antagonists decreased hypoperfusion and postictal phenomena (farrell, 2016, 2017). the objective of this research is to study the effect of acetaminophen and nimodipine to reduce postictal phenomena after ect induced seizures. a prospective, three conditions crossover trial will be conducted, with randomized condition allocation, open-label treatment, and blinded end-point evaluation (probe design; hansson, hedner, \& dahlof, 1992). thirty-three adult (age \>17 years) patients referred to treatment with ect for a depressive episode will be included to achieve a statistical power of .80. this will be feasible in one year. a single dose of nimodipine (60 mg) or acetaminophen (1000 mg) or no additional treatment will be given prior to a maximum of 12 ect-sessions per patient. patients will be randomly assigned to predefined treatment sequences. eeg and mri measures will serve as main outcome measures, as well as psychometric tests. data will be stored on two separate hard disks, one including patient sensitive information for identification, the other with anonymized data only (for the sponsor). patients will be recruited by doctors at rijnstate hospital arnhem. a mixed model with repeated measurements analysis will be conducted for the primary outcome measures.

Eligibility criteria:
inclusion criteria: * adulthood (age \> 17 years); * current clinical diagnosis of depressive episode (unipolar, bipolar, schizoaffective); * willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements. exclusion criteria: * known adverse or allergic reactions to acetaminophen or nimodipine; * chronic use of acetaminophen, calcium-antagonists or nsaid's that cannot be interrupted for less than two days before the ect-session;

Keywords: epilepsy depression electroconvulsive therapy postictal clinical trial postictal hypoperfusion/hypoxia
eras on cervical surgery

Conditions: Cervical Spondylosis

Summary: this study is to evaluate the application effect of the concept of accelerated rehabilitation surgery in the perioperative period of patients with cervical spondylosis through a retrospective cohort study

to evaluate the effect of a series of optimization measures in eras among the patients during perioperative period who underwent cervical surgery. methods: a retrospective cohort study was conducted for the patients who underwent cervical spine surgery in a top three hospital in beijing from april to december 2018. according to whether to implement enhanced recovery surgery, the patients were divided into enhanced recovery surgery group (eras group) and control group. the self-designed data collection table was used to collect data in the patient's medical records, including general demographic data and disease treatment data, implementation of accelerated rehabilitation surgery and application effect. among them, the application effect includes the operation related complications, the visual analog scale (vas) score of neck and shoulder pain, the ability of daily living after discharge, the length of stay, the cost of hospitalization and other recent rehabilitation effect indicators, as well as the rehospitalization rate of 90 days and the japanese orthopaedic society four months after operation association (joa) score, neck disability index (ndi) score, neck and shoulder pain symptoms, neck and shoulder stiffness symptoms and other long-term rehabilitation indicators. independent sample t-test, rank sum test and chi square test were used to compare the differences between the two groups. on the basis of single factor analysis, combined with multi factor analysis, the impact of groups on outcome indicators was clarified, included 90-day readmission, reexamination time, follow-up joa score, ndi score, neck and shoulder pain symptoms and neck and shoulder stiffness symptoms.

Eligibility criteria:
inclusion criteria: * ① patients with cervical spondylosis were definitely diagnosed; ② cervical spine surgery was performed under general anesthesia; ③ age ≥ 18 years old; exclusion criteria: * ① patients with cervical deformity correction surgery; ② patients who underwent secondary cervical spine surgery; ③ patients with spinal cord injury caused by trauma (4) patients with thoracic and atlantoaxial diseases and corresponding surgery; ⑤ ankylosing spondylitis patients; ⑥ patients with cerebral infarction, cerebral palsy and nerve root injury.

Keywords: enhanced recovery after surgery, cervical spondylosis, outcome measures
pilot study of cyclobenzaprine for treatment of sleep disturbance in aromatase inhibitor-treated breast cancer patients

Conditions: Sleep Initiation and Maintenance Disorders; Pain

Summary: many women with breast cancer who are treated with aromatase inhibitor medications develop difficulty sleeping and fatigue during treatment. some examples of aromatase inhibitor medications include anastrozole (arimidex), exemestane (aromasin), and letrozole (femara). frequently, sleeping pills do not work very well to improve sleep. cyclobenzaprine (flexeril) is a medication that was originally developed to treat muscle spasms. it may also improve sleep in patients with chronic pain disorders, such as fibromyalgia. in this study we are testing to see if cyclobenzaprine at bedtime will help improve sleep in women treated with aromatase inhibitors.


Eligibility criteria:
inclusion criteria: * female gender, age ≥ 18, postmenopausal. * histologically proven stage 0-iii invasive carcinoma of the breast * initiating or have been receiving a standard dose of aromatase inhibitor therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily) for up to a total of 48 months of ai therapy. * trouble sleeping during the past week. (after signing the informed consent document, subjects must also have a global psqi score of ≥5) * ecog performance status 0-2 (see appendix a). exclusion criteria: * known hypersensitivity to cyclobenzaprine or any of the inactive ingredients * diagnosis of sleep apnea that is currently interfering with sleep or requiring cpap, restless leg syndrome that is currently interfering with sleep or requiring medication, or epworth sleepiness scale \>10. * subjects with a history of hypothyroidism must have been on a stable dose of thyroid replacement medicine for at least 3 months prior to enrollment * treatment with steroids within 1 month * treatment with monoamine oxidase inhibitors (mao-i) within 14 days of enrollment. * concurrent treatment with bupropion, mao inhibitors, phenothiazines (including thioridazine), selegiline, tramadol, or medications known to prolong the qt interval (www.azcert.org/medical-pros/drug-lists/drug-lists.cfm) * currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder * known moderate or severe hepatic impairment * history of congestive heart failure or cardiac arrhythmia (other than atrial fibrillation); myocardial infarction within the past 6 months * uncontrolled narrow-angle glaucoma * pregnant or breast feeding * serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation

Keywords: breast cancer aromatase inhibitor
a smartphone application (quitbot) for the improvement of smoking cessation among american indians and alaska natives, naitive trial

Conditions: Cigarette Smoking-Related Carcinoma

Summary: this clinical trial develops a chatbot smartphone application (app), quitbot, and text messaging to help american indians (ai) and alaska natives (an) to quit smoking commercial tobacco (smoking cessation), and evaluates two remote smoking cessation programs to see how well they work for helping ai/an people quit smoking commercial tobacco. ai/an populations have one of the highest rates of commercial cigarette smoking of any racial and ethnic group in the united states (us). they also have a higher rate of developing smoking-related cancer but are less likely to quit smoking. the two programs are designed to provide personalized support in setting a smoking cessation goal, tasks to reach the smoking cessation goal, and motivation to remain smoke-free. this may help to keep participants engaged and support them in their quit efforts, and may improve smoking cessation among ai and an.

outline: participants are randomized to 1 of 2 arms. both groups receive access to a 42-day quit smoking program. arm i: participants receive daily quitbot program chatbot messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days. arm ii: participants receive daily quitbot text messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days. after completion of study intervention, participants are followed up at 3, 6, and 12 months and may be contacted thereafter for up to 24 months.

Eligibility criteria:
inclusion criteria: * self-identifying as american indian or alaska native, either alone or in combination with other races * age 18 and older * smoking combustible cigarettes daily in the past year * interest in quitting smoking * interest in learning skills to quit smoking * willing to be randomly assigned * have daily access to their own android or iphone smartphone * ability to download a smartphone app * ability to read english * not currently (i.e., within past 30 days) using other smoking cessation interventions * no prior participation in our studies * no prior use of sft * no household or family member participating * us residency for the next twelve months * willingness to complete follow-up assessments at the 3-, 6-, and 12-month follow-ups * providing email, phone number(s), and mailing address exclusion criteria: * the reverse of the inclusion criteria * pregnant or breastfeeding * use of other tobacco products (e.g., ceremonial use of tobacco, e-cigarettes) will be assessed but is not an exclusion criterion, as it would limit the study's generalizability
a study to compare the efficacy of rapydan versus tetracaine gel

Conditions: Healthy; Anesthesia

Summary: tetracaine gel 4% is a topical anaesthetic gel commonly used in the uk that contains 40 mg of tetracaine base per gram. adequate anaesthesia can usually be achieved following a 30 minute application time for venopuncture and a 45 minute application time for venous cannulation. the hypothesis is that rapydan medicated plaster is more effective than tetracaine gel in preventing venous cannulation related pain when applied for the recommended treatment durations of 30 minutes and 45 minutes respectively.

tetracaine gel 4% is a topical anaesthetic gel commonly used in the uk that contains 40 mg of tetracaine base per gram. adequate anaesthesia can usually be achieved following a 30 minute application time for venopuncture and a 45 minute application time for venous cannulation. the hypothesis is that rapydan medicated plaster is more effective than tetracaine gel in preventing venous cannulation related pain when applied for the recommended treatment durations of 30 minutes and 45 minutes respectively. this study has been withdrawn and no additional data is available.

Eligibility criteria:
inclusion criteria: * healthy male subjects of any race, 18 yrs or older * no clinically significant findings on physical exam * signed informed consent exclusion criteria: * damaged, denuded or broken skin at the designated site for application of the medicated plaster or gel. * know allergies to lidocaine, tetracaine or other local anaesthetics * concomitant use of prescription strength analgesics

Keywords: topical anesthesia rapydan topical anaesthesia for venous cannulation
a brief version of biofeedback therapy for panic disorder

Conditions: Panic Disorder; Feedback, Psychological

Summary: the study is to examine the therapeutic effect of a brief version of biofeedback therapy (developed bu the research team) on panic disorder. it is a randomized controlled design. the severity of panic symptoms of two groups of panic patients (reveiving biofeedback therapy or not) were measured before and after the six week duration. besides, the severity of anxiety, depressive, somatic symptoms, and physiological indexes were recorded.

the purpose of this study is trying to find out whether our newly developed brief version of biofeedback is an effective treatment approach for panic disorder. at the same time, the investigators want to clarify the change of bio- and psycho- indices present through the process. patient recently experienced panic attacks are recruited in this study. the diagnosis of "panic disorder" is made by psychiatrists according to the diagnostic and statistical manual of mental disorders(dsm-5) criteria. subjects are randomly assigned to medication group or biofeedback therapy. the biofeedback therapy is conducted by psychologists following the structure way. every subject will be measured both the bio and psycho indices on week 0, 3, and 6 under 6-week observation. in the end of the study, the investigators hope to analyze and clarify the treatment effects of our design, and also to exam the meanings of these indices, in order to find out an effective treatment approach.

Eligibility criteria:
inclusion criteria: the panic disorder cases of the national taiwan university hospital yunlin branch psychiatric outpatient department (huwei, douliou) have more than one time of panic attack in nearly three months. exclusion criteria: 1. the age is younger than 20 or older than 70 years. 2. with psychotic symptoms or cognitive dysfunction. 3. a major physical illness (physical illness with fatal risks, such as cancer, myocardial infarction) 4. unable to read or understand the questionnaire

Keywords: psychiatry psychological psychotherapy randomize biofeedback
prescription-grade crystalline glucosamine sulfate therapy in erosive hand osteoarthritis

Conditions: Erosive Osteoarthritis of the Hand

Summary: the objective of this study is to evaluate the efficacy of prescription-grade crystalline glucosamine sulfate (pcgs), as an add-on treatment to conventional therapy, compared to usual therapy alone, in patients with erosive osteoarthritis of the hand (ehoa). this is a 6-months retrospective study including patients with concomitant gonarthrosis and ehoa, defined as the presence of central erosion in at least two interphalangeal joints. eligibility criteria are symptoms duration for at least 3 months, with a global hand pain score ≥40 mm on a 0-100 visual analogue scale (vas) and a functional index for hand osteoarthritis (fihoa) score ≥6. the participants are stratified into two groups based on whether or not pcgs, at the daily dose of 1500 mg, was added to the conventional therapy for hand osteoarthritis (hoa). the latter consists of education and training in ergonomic principles, exercise and the use on-demand of acetaminophen or oral non-steroidal anti-inflammatory drugs. patients are evaluated at baseline, after 3 and 6 months. primary outcome measures are the change from baseline to month 6 in vas and in fihoa score. secondary outcomes are duration of morning stiffness, health assessment questionnaire (haq), medical outcomes study 36-item short form (sf-36), symptomatic drugs consumption and percentage of treatment responders, according to the omeract/oarsi criteria.


Eligibility criteria:
inclusion criteria: * erosive hand osteoarthritis, defined as the presence of the classical central erosion in at least two interphalangeal joints * treatment for at least 6 consecutive months with prescription-grade crystalline gs at the daily dose of 1500 mg in addition to the conventional therapy or with usual care alone. * symptoms duration for at least 3 months defined as global hand pain score superior to 40 mm on a 0-100 vas and a fihoa score of at least 6. exclusion criteria: * medical history of any inflammatory joint disease, septic arthritis, previous articular fracture of the concerned joints, or the presence of any other rheumatic diseases that could cause secondary oa, such as hemochromatosis * concomitant therapy with sysadoas, other than pcgs, steroids by any route of administration and intra-articular injection of any joint with hyaluronic acid during the previous 6 months * concomitant treatment with intra-muscular or intra-venous bisphosphonates in the previous 6 months * contraindications or special warnings for pcgs presented in the data sheet.
laser therapy to treat the dry mouth of sjogren's syndrome

Conditions: KERATOCONJUNCTIVITIS SICCA; XEROSTOMIA; SICCA SYNDROME; PRIMARY SJOGREN SYNDROME

Summary: this study was designed to test the efficacy and safety of low laser therapy to treat the xerostomia of patients with primary sjogren's syndrome.

the sjogren's syndrome is a disease that affects around 0,5% of the population and is mainly characterized for inflammatory involvement of salivary and lacrimal glands. the xerostomia leads to low quality of life caused by dry sensations that can disturb the taste, the speaking, the swallow and chewing functions in the affected patients. the absent saliva can cause increase of dental caries and decays. until now, there is no effective treatment that increases the amount of saliva and the patients have low improvements with cholinergic drugs such as pilocarpine and cevimeline. these drugs can cause unpleasant collateral effects.

Eligibility criteria:
inclusion criteria: * patients with primary sjogren syndrome according criteria american european 2002. * salivary flux non stimulated \< 0,1 ml/min. exclusion criteria: * hepatitis b and/or c * radiotherapy in the glandular area (previous) * other connective diseases * thyroidopathy non compensated * gvhd graft-versus-host disease * hiv * sarcoidosis

Keywords: sjogrens syndrome syndrome, sjogren's sjogren syndrome sicca syndrome syndrome, sicca
study to evaluate atp-induced pain and atp-induced dermal vasodilation by iontophoresis (0000-118)(completed)

Conditions: Osteoarthritis Pain

Summary: this study will evaluate atp-induced pain (aip) and atp-induced dermal vasodilation (aidv) as target engagement tools for future development of analgesics.


Eligibility criteria:
inclusion criteria: * subject is in generally good health * subject is willing to abstain from smoking within 24 hours of each iontophoresis treatment and limit smoking to 5 or less cigarettes per week during the study exclusion criteria: * subject has a history of dermatitis, psoriasis, or eczema * subject has active asthma and/or hay fever at the time of the screening visit * subject is unable to refrain from use of analgesics within 3 days prior to each treatment period
direct left ventricular rapid pacing via the valve delivery guide-wire in tavi

Conditions: Aortic Valve Stenosis

Summary: the purpose of this study is to determine whether a left ventricular rapid pacing using the valve delivery guide-wire in transcatheter aortic valve implantation (tavi) reduces the overall procedure duration in comparison with the conventional method.

use of temporary pacing via a right ventricular lead in tavi is still mandatory to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. this requires an additional venous vascular access and a pacing catheter which are both likely to generate complications. this study compares the standard right ventricular rapid pacing to a new and simplified technique : a left ventricular rapid pacing is provided via the back-up 0.035 " guidewire. the cathode of an external pacemaker is placed on the tip of the 0.035" wire and the anode on a needle inserted into the groin. insulation is ensured by the balloon or tavi catheter.

Eligibility criteria:
inclusion criteria: * subject is eligible for a tavi * access considered for aortic valve bioprothesis delivery is transfemoral * aortic valve bioprothesis considered is edwards sapien 3® et/ou xt® * subject is ≥ 18 years of age * subject has signed informed consent form exclusion criteria: * pregnancy * subject already included in this study * subject included in another study and whose inclusion in easy tavi implies a deviation in either study

Keywords: tavi aortic valve bioprothesis tavi simplification aortic stenosis rapid left ventricular pacing tavr
efficacy and safety study of wtx101 (alxn1840) in adult wilson disease patients

Conditions: Wilson Disease

Summary: the main purpose of the study was to evaluate the efficacy of alxn1840 (formerly wtx101) for 24 weeks on non-ceruloplasmin-bound copper (ncc) concentrations adjusted for molybdenum plasma concentration in participants newly diagnosed with wilson disease (wd) who were aged 18 and older and who had ncc concentrations within or above the reference range at the time of enrollment in the study. the study consisted of a 24-week treatment period, followed by a planned 36-month extension period.


Eligibility criteria:
inclusion criteria: * able to understand and willing to comply with study procedures, restrictions, and requirements, as judged by the investigator. * newly established diagnosis of wd by leipzig-score ≥ 4 documented by testing as outlined in 2012 european association for the study of the liver wilson disease clinical practice guidelines. * ncc levels within or above the normal reference range (0.8 to 2.3 micromole). * willing to undergo 48 hour washout from current wd treatment exclusion criteria: * treatment for greater than 24 months for wd with chelation therapy (for example, penicillamine, trientine hydrochloride) or zinc therapy. * decompensated hepatic cirrhosis. * model for end-stage liver disease score \> 11. * modified nazer score \> 6. * gastrointestinal bleed within past 6 months. * alanine aminotransferase \> 5 x upper limit of normal. * marked neurological disease requiring either nasogastric feeding or intensive in-patient medical care. * severe anemia with a hemoglobin \< 9 grams/deciliter.