Kornimate/medical-research-clean huggingface dataset:
tdcs in chronic migraine with medication overuse (edisom)

Conditions: Migraine Disorders; Medication Overuse Headache

Summary: transcranial direct current stimulation (tdcs) was suggested to provide beneficial effects in chronic migraine (cm), a condition often associated with medication overuse (mo) for which no long-term therapy is available.

we conducted a randomized controlled trial to assess long-term efficacy of tdcs. adults diagnosed with cm and mo were assigned to receive in a 1:1:1 ratio anodal, cathodal, or sham tdcs daily for five consecutive days, along with standardized drug withdrawal protocol with intravenous administration of dexamethasone 4 mg and ademetionine 200 mg in saline solution, and oral bromazepam 1.5 mg three times daily. primary outcome was 50% reduction of days of headache per month at 12 months. co-secondary outcomes were 50% reduction of days of headache per month at 6 months, reduction of analgesic intake per month, and change in disability and quality of life, catastrophizing, depression, state and trait anxiety, dependence attitude and allodynia intensity. patients were not allowed to take any migraine prophylaxis drug for the entire study period.

Eligibility criteria:
inclusion criteria: * chronic migraine with medication overuse according to the international headache society criteria. diagnosis was confirmed on the basis of a daily headache diary that all eligible patients filled out in the last month prior to the enrollment. patients should have failed at least two prophylaxis therapies. written informed consent. exclusion criteria: * known diagnosis of major depression or other major psychiatric disorders identified after psychiatric consultation, cardiac pace maker, clips for previous head surgery, cochlear implant, history of epilepsy, known idiopathic intracranial hypertension, harmful alcohol consumption, pregnancy.
a multicenter study to evaluate a borrelia diagnostic test in subjects with early stage or late stage lyme disease

Conditions: Lyme Disease

Summary: this study will evaluate advanced laboratory services borrelia diagnostic test by culturing borrelia spirochetes from human serum in subjects with early or late lyme disease. this is an 8 month study. subjects entering the study will have two blood samples collected one month apart if they have early lyme disease and one blood sample collected if they have late lyme disease. subjects who sign an irb-approved consent form and meet the inclusion and exclusion criteria will be entered into the study. subjects will be assigned a subject number upon entry and this number will be retained throughout the study.


Eligibility criteria:
inclusion criteria: 1. subject must provide written informed consent prior to the conduct of any study-related procedures. 2. male or female subjects who are at least 18 years of age. 3. subjects are suspected to have early lyme disease based on the following criteria: signs, symptoms and clinical history consistent with early-stage lyme disease. subjects must have a medical practitioner-diagnosed erythema migrans (em) rash and should have systemic symptoms indicative of disseminated infection. symptoms may include fever, headache, fatigue, myalgias, arthralgias, and stiff neck. paired acute and convalescent titers will be drawn (first draw at time of initial visit and second draw 4 weeks later) or, 4. subjects are suspected to have late lyme disease based on the following criteria: signs, symptoms and clinical history consistent with late stage lyme disease, including but not limited to disseminated rash, arthritis, meningitis, facial palsy, or carditis. 5. subjects must be willing and have the ability to safely have the required quantity of blood drawn for the study at the discretion of the investigator. 6. subjects must have blood samples freshly collected (no supplemental frozen samples) and the samples must reach alsi's laboratory on a weekday and within 24 hours of being drawn. --- exclusion criteria: 1. early lyme disease: subjects without an em rash or do not have symptoms recognized as being associated with lyme disease. 2. exposure to antibiotics of any type during the 6 weeks prior to the initial blood sample collection. 3. immune deficiency significant enough to render serological tests less reliable. 4. the subject is unwilling or unable to safely have the required quantity of blood drawn for this study. 5. subjects who are not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation. 6. subjects that have any other condition or situation which, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study. 7. subjects that have undergone testing for lyme disease within the past year. 8. subjects that have a prior diagnosis of lyme disease.

Keywords: borrelia spirochetes culture immunostaining
speed of increasing milk feeds trial

Conditions: Premature Birth; Late-onset Invasive Infection; Necrotizing Enterocolitis

Summary: survival of preterm infants has increased greatly over the years, so a major aim now is to improve the long term outlook for these babies and to avoid serious complications. the way babies are fed in early life affects short and long-term health and survival. because the bowels of preterm infants have not matured, they cannot digest large volumes of milk feeds straight away. until the gut matures, nutrition is provided by intravenous drip while the amount of milk given is gradually increased over time. increasing the amount of milk rapidly may increase the risk of gut complications. increasing the amount of milk given more slowly means that intravenous nutrition is needed for longer; there is an associated risk of infection proportional to the time the intravenous line is present in the bloodstream of these infants. despite the importance of milk feeding preterm infants, there have been few studies to inform how best to balance these risks, and what the best way to increase feeds in these infants is - this study sets out to address this missing information. the study will compare two different speeds of milk feed increase, one 'faster' and one 'slower', both within rates currently used in united kingdom neonatal units. the study aims to find out if either speed of milk feed increase gives better outcomes for the infants. investigators will measure a variety of outcomes, such as survival without disability, infection, bowel problems, growth and long-term physical and mental development, as well as the impact on families and the national health service, including costs. the study is being led by an established team of researchers who have run similar studies before, and uses an established network of neonatal units that have taken part in previous studies.


Eligibility criteria:
inclusion criteria: * gestational age at birth \<32 weeks, or birth weight less than 1,500 g * receiving ≤30 ml/kg/day of milk at randomisation * written informed parental consent is obtained to ensure the widest applicability to preterm infants across the united kingdom, those exclusively breast milk fed, formula milk fed, or receiving mixed feeds will be included exclusion criteria: * infants with a severe congenital anomaly * infants who, in the opinion of the treating clinician, have no realistic chance of survival * infants who are unlikely to be traceable for follow-up at 24 months of age corrected for prematurity (for example, infants of non-united kingdom residents)

Keywords: preterm very low birth weight feeding enteral milk sepsis necrotizing enterocolitis (nec)
efficacy study measuring the impact of treatment with viagra on the depressive symptoms of men with erectile dysfunction

Conditions: Impotence; Depression

Summary: this study will measure the impact of treatment with viagra on the depressive symptoms and quality of life in men with erectile dysfunction who have untreated depressive symptoms meeting the dsm-iv criteria for dysthymia or depression not otherwise specified (nos), including minor depressive symptoms but excluding any form of psychotic disorder.


Eligibility criteria:
inclusion criteria: * men above age of majority with ed (shim score less than 21) * beck depression inventory ii score between 14 and 28 exclusion criteria: * subjects with symptoms of mania or major depressive disorders as demonstrated by the mini international neuropsychiatric interview (mini) * subjects who require treatment with antipsychotics, mood stabilizers, antidepressant agents or lithium (concomitant use of benzodiazepines is allowed) or who has required treatment with any of the above medication within the past 3 months
study of ibi3009 in participants with unresectable, metastatic or extensive-stage small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the main purpose of this study is to evaluate the safety and tolerability of ibi3009 and to determine the maximum tolerated dose (mtd) and/or the recommended dose for expansion (rde) of ibi3009.


Eligibility criteria:
inclusion criteria: 1. participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. male or female subjects ≥ 18 years old. for part 1, age ≥18 years and ≤75 years; 3. eastern cooperative oncology group (ecog) performance status score of 0-1; 4. minimum life expectancy of ≥ 12 weeks; 5. adequate organ function confirmed at screening period; 6. histologically or cytologically confirmed unresectable,metastatic or extensive-stage small cell lung cancer (sclc). exclusion criteria 1. participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study; 2. has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to grade 0 or 1 toxicity according to nci ctcae v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator's discretion) prior to the first dose of the study drug; 3. known allergies, hypersensitivity, or intolerance to ibi3009 or its excipients; 4. undergone major surgery (craniotomy, thoracotomy or laparotomy, and other surgery according to investigator's discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.; 5. women who are pregnant, have positive results in pregnancy test or are lactating; 6. not eligible to participate in this study at the discretion of the investigator.
evaluation of a partially hydrolyzed in improving fgids symptoms

Conditions: Functional Gastrointestinal Disorders

Summary: evaluation of a partially hydrolyzed whey protein infant formula in improving functional gastrointestinal disorders (fgids) symptoms

this study will investigate the prevalence of shanghai area's infant with fgids symptom and contrast for the fgids symptoms by using different intervention means, and evaluate the effectiveness of fgids symptoms in infants by using partially hydrolyzed whey protein and low lactose infant formulation.

Eligibility criteria:
inclusion criteria: * infants is formula-fed or mixed feeding a cow milk protein-based formula for less 7 days prior to enrollment. * infant is between 30-180 days of age. * infant's parent(s) or legally authorized representative(lar) has voluntarily signed and dated an informed consent form (icf), approved by an independent ethics committee/institutional review board (iec/irb) prior to any participation in the study. exclusion criteria: * complementary food was added for infants or parents are willing to add complementary food during study. * suffer from infection/illness. * infant has suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism. * infant has visible bloody stools (detected before enrollment) prior to enrollment. * participation in another study.
cbt vs rtw intervention for patients with common subclinical mental illness in primary care

Conditions: Anxiety Disorders; Major Depression; Stress Disorders; Primary Insomnia

Summary: background: common mental illness, such as anxiety disorders and depression, is the main cause for sick leave in sweden. cognitive behavior therapy (cbt) has been shown to be effective in alleviating target symptoms of these disorders, but its effect on sick leave rates has not been sufficiently addressed. the investigators have developed an intervention called return to work (rtw), which is based in cognitive behavioral theory, that has a primary aim of helping sick-listed patients with common mental illness return to work. this new treatment has not been evaluated in a randomized controlled trial. aims: the aim of this study is to investigate the effect of cbt and rtw for subclinical common mental illness in a randomized controlled trial conducted in primary care. participants will be randomized to diagnosis specific cbt (n=50), rtw (n=50. main outcomes are days of sick leave and clinician severity rating of psychiatric symptoms. this study could contribute to new knowledge regarding how to best treat patients on sick leave with mild common mental illness.


Eligibility criteria:
inclusion criteria: * have been on sick leave (at least 50%) for at least 1 month and not more than 6 months * have subclinical levels of anxiety disorder diagnosis (obsessive compulsive disorder, social phobia, panic disorder, generalized anxiety disorder, post-traumatic stress disorder, specific phobia), or/and major depression, or/and maladaptive stress reaction, or/and primary insomnia. severity measured by clinical severity rating (csr) 2-3 for mild subclinical level exclusion criteria: * a higer score than 3 on the clinician severity rating scale * a lower score than 2 on the clinician severity rating scale
metabolic effects of lac-phe

Conditions: Healthy Overweight/obese

Summary: the goal of this double-blinded, randomized cross-over clinical trial is to assess the isolated (i.e. outside the context of exercise) effects of lac-phe on appetite and glucose concentrations in healthy volunteers with obesity (bmi 28-35). the main questions it aims to answer are: * does lac-phe reduce appetite in humans? * does lac-phe have glucose-lowering properties in humans? during the study, participants will: * receive an intravenous infusion of lac-phe on one study day and a nacl infusion on another study day. * drink a standard mixed meal * eat an ad libitum meal test * answer appetite questionnaires * indirect calorimetry * blood samples for hormone and substate analyses


Eligibility criteria:
inclusion criteria: * a body mass index (bmi) between 28-35 kg/m2 * older than 18 years of age * hgb within a normal range (females: 7.3-9.5 mmol/l, males: 8.3-10.5 mmol/l) * females can be included if they are either postmenopausal or actively use hormonal contraception (e.g., oral contraceptive pill or hormone-releasing intrauterine device). exclusion criteria: * medications affecting glucose metabolism (e.g., saxenda). * anemia * diabetes * ongoing cancer or other acute/chronic serious diseases (pi will determine) * inability to understand danish or english * deemed unsuitable to participate by the pi and co-investigators.

Keywords: lac-phe appetite glucose metabolisme
follow up by general practitioner after self-poisoning

Conditions: Suicidal and Self-injurious Behaviour

Summary: the study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour.

patients hospitalized after an episode of self poisoning will be randomly assigned into intervention an control groups. the intervention is close follow up by general practitioner six months. both groups will receive treatment as usual.

Eligibility criteria:
inclusion criteria: * self poisoning (according to the who definition) * ability to fill out questionnaire exclusion criteria: * hospitalization into psychiatric ward * unknown address or id * not registered with general practitioner * if institutionalized or in jail.

Keywords: depression hopelessness suicidal ideation
low doses amitriptyline & chronic neck pain

Conditions: Neck Pain

Summary: the objective of this prospective randomized and controlled study is to evaluate the efficacy and safety of low dose of amitriptyline (5 mg) in the management of chronic neck pain.

patients with chronic neck pain, lasting since at least 3 months, are recruited from our pain clinic. after verification of inclusion and exclusion criteria, patients consenting to enter the study are assigned randomly to one of the following groups: 1-amitriptyline 5 mg for 2 months 2- placebo for 2 months. co-morbidities and other painful conditions are noted, and then clinical evaluation of the patient is performed; pain is assessed according to visual analog scale, anxiety, depression, insomnia and disability are evaluated by adapted scores (bergen insomnia scale, neck pain disability score, neck pain diary \& anxiety and depression score). patients are followed at 2 months and outcome measures are assessed.

Eligibility criteria:
inclusion criteria: * chronic neck pain (since more than 3 months, and more than 15 days/month) * normal neurologic exam * x-ray = normal or loss of lordosis exclusion criteria: * neurologic signs or symptoms * past history of neck surgery * mri = abnormal findings except for loss of lordosis * past cervical trauma * severe depression * drug abuse * pregnancy * follow-up not possible * cardiac rhythms problems * glaucoma * urinary tract obstruction or prostatism

Keywords: amitryptiline chronic pain neck pain
effect of cannabis on e-cigarette use behavior

Conditions: Cannabis Use; Tobacco Use; Electronic Cigarette Use

Summary: the purpose of this study is to determine the impact of tetrahydrocannabinol (thc) administration on motivational, subjective, and physiological effects of electronic cigarettes. the study's goals are to test demand for e-cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. researchers will compare multiple doses of thc and a placebo in participants who smoke e-cigarettes and either smoke or vape thc in the laboratory.

a full-factorial laboratory study will be conducted to determine the impact of acute thc administration on the dose-related motivational, subjective, and physiological effects of electronic cigarettes. this study will employ a double-blind, placebo-controlled, within-subjects crossover design to examine the dose-effects of thc on e-cigarette use. the study will use multiple active doses of thc and placebo (0, 5, and 30 mg; corresponding to 0, 1, and 6 standard thc unit doses). participants will be randomized to either smoked or vaporized thc administration using a between-subjects approach to evaluate the effect of congruent versus incongruent routes of thc and tobacco administration on study outcomes.

Eligibility criteria:
inclusion criteria: 1. healthy non-treatment seeking adults aged 21 or older 2. report daily use of e-cigarettes 3. biological confirmation of e-cigarette use: have an expired carbon monoxide (co) level of less than 6 ppm and a positive urine cotinine test at screening 4. report current use of cannabis (at least 1 occasion per week) 5. have experience with the inhalation route of administration for cannabis 6. biological confirmation of cannabis use: have a positive urinary thc drug test at screening. 7. for women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study. exclusion criteria: 1. report current intention to reduce or quit cannabis or tobacco use within the next 30 days 2. meet diagnostic and statistical manual (dsm-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine 3. test positive for illicit drugs other than cannabis and tobacco 4. positive breath alcohol test at study admission 5. have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity 6. have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the columbia suicide severity rating scale (c-ssrs) 7. are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding 8. have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., prinzmetal's angina) 9. are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.

Keywords: cannabis e-cigarette electronic cigarette marijuana thc tobacco
metallosis on tissues and serum metal levels in children

Conditions: Orthopedic Disorder; Retained Metal Implant

Summary: slightly elevated blood metal levels have been found in adults undergoing hip and knee replacement. it is unknown whether pediatric patients with metal implant(plates/screws/rods) have elevated blood metal levels. this may have an impact on practice if children have high blood metal levels with routine orthopedic implants. if researchers find elevated metal levels, they may recommend patients to have the plates removed or may switch to a different type of metal. further work on this topic is needed.

metal implants are routinely placed in children for treatment of fracture or deformity. long-term effects of indwelling metal implants are not well-understood. data from this study will provide guidances as to whether some metals are safer for children (stainless vs. titanium alloys). in addition, we will document the presence of serum ion concentration for children with metal implants in place and whether this resolves after implant removal. tissues adjacent to implants will be evaluated for signs of metallosis and wear debris. presence of metallosis will be correlated with serum ion concentration. in vivo studies will provide data on whether metal exposure to bone cells and fibroblasts affects their inflammatory cascade and function. based on these findings, surgeons can better counsel patients whether routine implant removal is advisable or whether stainless steel implants are safer for long-term retention compared to titanium implants. further, novel drug targets for treatment and prevention of metallosis will be developed. this project will foster collaboration and future partnerships between the sanford health and mayo clinic research teams

Eligibility criteria:
inclusion criteria: * ages 4 years - 18 years * stainless steel, titanium or titanium-alloy based implants, scheduled for surgery * de novo surgery where titanium implant placement exclusion criteria: * concomitant infection