Kornimate/medical-research-clean huggingface dataset:
evaluation of liver disease in individuals attending alcohol abuse treatment - a randomized controlled pilot trial

Conditions: Liver Diseases

Summary: this pilot study aims to evaluate the feasibility of a non-blinded randomized controlled trial with a parallel group design of an invitation to an evaluation of liver disease (intervention) compared to standard care with no invitation, among individuals in alcohol abuse treatment.

alcohol-related liver disease (ald) is responsible for about 80% of all liver disease in denmark. the prognosis for ald is good, if detected early and abstinence is obtained. unfortunately ald is often diagnosed at a late state and the 1-year survival is only 30%. currently there is no available systematic screening for fibrosis/cirrhosis among patients with longterm abuse of alcohol and thereby high risk for developing ald. transient elastography (te) is a non-invasive, risk free and quick method of detecting fibrosis. te is validated for diagnosing fibrosis and ruling out cirrhosis. 40 patients will be enrolled in the study with a 1:1 randomization. baseline data is collected and informed concent is obtained at the local alcohol abuse treatment center, novavi køge. the fibroscan and blood samples are done at zealand university hospital, køge. follow-up is done after 6 months, by a project nurse, blinded to the intervention. if the study proves to be feasible, our aim is to extend the study in order to investigate wether the interventions described above, could help decrease alcohol consumption/maintain abstinence for patients in alcohol treatment. moreover the prevalence of fibrosis and cirrhosis found by fibroscan is examined.

Eligibility criteria:
inclusion criteria: * must be enrolled at alcohol treatment center novavi koege, denmark * maximum 6 months of treatment at novavi koege exclusion criteria: * known severe liver disease * life expectancy less than 6 months * unable to give informed written consent

Keywords: alcohol pilot study feasibility
statin therapy for ischemic and nonischemic cardiomyopathy

Conditions: Cardiovascular Disease; Cardiomyopathy; Heart Disease; Myocardial Disease; Myocardial Ischemia

Summary: the purpose of this study is to see if taking a cholesterol lowering drug lipitor (atorvastatin calcium)will increase the number of endothelial progenitor cells (epc's) circulating in the blood of heart failure patients taking this cholesterol-lowering drug, and if this will also show an improvement in the damaged areas of the patient's hearts as documented by mri scans.

this study involves the testing of blood for cholesterol levels and flow cytometry tests to count the number of epc's in your blood. these tests are routinely performed to gain knowledge about a person's health. if any incidental findings are identified as a result of your participation in this research study, you will be notified and referred to your doctor or appropriate health care professional. you are being asked to provide a blood sample that will be used to determine the usual numbers of epc's circulating in the blood of healthy people who have no risk factors for heart disease. your results will be compared with those of patients who have heart failure. flow cytometry is a special laboratory test that can count, separate, and detect characteristics of cells in blood. your blood sample will be analyzed using flow cytometry. endothelial progenitor cells (epc's) are immature cells that are necessary for new blood vessel formation. epc's will be separated by flow cytometry and counted. you will not be given the results of your flow cytometry study.

Eligibility criteria:
inclusion criteria: * ischemic cardiomyopathy (as defined above) with ejection fraction \< 35% * non-ischemic cardiomyopathy with ejection fraction \< 35% * ncep atpiii indication for therapy with a statin drug * no statin therapy within previous 6 months of study enrollment * prescribed stable doses of standard heart failure therapies including beta blocking agents, angiotensin converting enzyme inhibitors or angiotensin receptor blockers, and diuretic agents as required exclusion criteria: * pregnant or lactating * myocardial infarction within 6 months preceding study enrollment * primary valvular heart disease * surgical or catheter based revascularization within the preceding 6 months * documented viral or inflammatory myocarditis or cardiomyopathy * peripartum cardiomyopathy * infiltrative cardiomyopathies * chemotherapy associated cardiomyopathy * without indication for statin therapy * contraindication to statin therapy including hepatic dysfunction, history of rhabdomyolysis or prior intolerance of statin therapy * contraindication to magnetic resonance imaging

Keywords: cardiovascular disease cardiomyopathy heart disease myocardial disease myocardial ischemia
nmda modulation in major depressive disorder

Conditions: Major Depressive Disorder

Summary: most of the current antidepressants for major depressive disorder (mdd) are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. nmda hypofunction has been implicated in the pathophysiology of depression. therefore, this study will examine the efficacy and safety as well as cognitive function improvement of an nmda enhancer (nmdae) in the treatment of mdd in the adults.

major depressive disorder (mdd) is a complex and multi-factorial disorder. most of the current antidepressants are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. many patients have significant side effects after treatment with antidepressants which hamper the motivation for treatment and medication adherence. nmda hypofunction has been implicated in the pathophysiology of depression. mdd is often associated with cognitive deficits which are not necessarily recovered by current antidepressants. the nmda receptor regulates synaptic plasticity, memory, and cognition. in our previous studies, cognitive improvement has been observed with treatment of nmda enhancers. therefore, this study will examine the efficacy and safety as well as cognitive function improvement of nmdae in the treatment of mdd in the general adults by comparing with sertraline (a selective serotonin reuptake inhibitor \[ssri\]) and placebo. the investigators will enroll non-elderly adult patients with mdd for an 8-week treatment. all patients will be randomly assigned into three groups: nmdae, sertraline, or placebo. the investigators will biweekly measure clinical performances and side effects. cognitive functions will be assessed at baseline and at endpoint of treatment by a battery of tests. the efficacy of three groups will be compared.

Eligibility criteria:
inclusion criteria: * have a dsm-5 (american psychiatric association) diagnosis of mdd * 17-item hamilton rating scale for depression total score ≥ 18 * free of antidepressant drugs for at least 2 weeks * agree to participate in the study and provide informed consent exclusion criteria: * current substance abuse or history of substance dependence in the past 6 months * history of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study * bipolar depression, schizophrenia or other psychotic disorder * moderate-severe suicidal risks * severe cognitive impairment * initiating or stopping formal psychotherapy within six weeks prior to enrollment * a history of severe adverse reaction to ssris * a treatment-resistant history (that is, they have failed to respond to two or more different classes of antidepressants with adequate dosage and treatment duration * a history of previously received electroconvulsive therapy * inability to follow protocol

Keywords: major depressive disorder nmda selective serotonin reuptake inhibitor
ravulizumab versus placebo in adult participants with dermatomyositis

Conditions: Dermatomyositis

Summary: this is a phase 2/3, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ravulizumab in adult participants with dermatomyositis (dm).

the study will be conducted in 2 parts: part a (phase 2) and part b (phase 3). there will be 3 periods in both part a and part b of this study: screening period, randomized controlled period, and open-label extension period.

Eligibility criteria:
key inclusion criteria: * 18 years of age or older at the time of signing the informed consent. * body weight ≥ 30 kilograms at the time of screening. * male or female. * diagnosis: meet 2017 american college of rheumatology/european league against rheumatism classification criteria for definite or probable dm. * participants who have an inadequate response or are intolerant to 1 or more dm treatments, including systemic corticosteroids or immunosuppressive/immunomodulatory therapies (for example, azathioprine, methotrexate, rituximab, intravenous immunoglobulin), either in combination or as monotherapy. * vaccinated against neisseria meningitidis within 3 years prior to initiating ravulizumab as per national and local guidelines. participants must receive the vaccination at least 2 weeks before first study intervention. the sponsor recommends that national and local guidelines for prophylactic antibiotics should also be followed. * female participants of childbearing potential and male participants must follow specified contraception guidance as described in the protocol. key exclusion criteria: * participants who have been diagnosed with cancer within the last 3 years need to have appropriate negative cancer screening as per local standard of care within 6 months before screening (basal or squamous cell skin cancer or carcinoma in situ of the cervix needs to have been excised and without evidence of residual disease for at least 3 months before screening). * evidence of active malignant disease or malignancies diagnosed within the previous 3 years including hematological malignancies and solid tumors. * participants with other forms of myositis. * as per investigator discretion, participants with significant muscle damage (for example, severe muscle atrophy, end stage muscle disease, mri with severe atrophy or fibrofatty replacement) * history of neisseria meningitidis infection. * human immunodeficiency virus (hiv) infection (evidenced by hiv type 1 or type 2 antibody titer). * active systemic bacterial, viral, or fungal infection within 14 days prior to ravulizumab administration. * presence of fever ≥ 38°celsius (100.4°fahrenheit) within 7 days prior to study drug administration on day 1. * history of hypersensitivity to murine proteins or to 1 of the excipients of ravulizumab. * pregnant, breastfeeding, or intending to conceive during the course of the study. * inability or unwillingness to adhere to the protocol requirements.

Keywords: ravulizumab alxn1210 ultomiris pharmacokinetics pharmacodynamics efficacy dm
kinectics of donor-specific anti-hla antibody after hla-incompatible allogeneic haematopoietic stem cell transplantation

Conditions: Haematological Malignancy

Summary: donor specific anti-hla antibody (dsa) is closely related not only to primary graft rejection (gr) after hla-incompatible transplantation, but also to the occurrence of primary pgf. desensitisation therapy can reduce the level of dsa in patients and decrease the incidence of pgf after transplantation. however, most studies at home and abroad have focused on dsa levels in recipients before transplantation, risk factors and their effects on prognosis. very few studies have focused on the rate of dsa positivity and its risk factors after transplantation. therefore, this project aims to clarify the rate of dsa positivity after hla-incompatible allo-hsct and reveal the influencing factors of post-transplantation dsa positivity with the help of a prospective, registry-based clinical cohort of hla-incompatible transplant recipients, in order to provide a basis for the prevention and treatment of dsa-induced graft rejection or pgf.


Eligibility criteria:
inclusion criteria: clinical diagnosis haematological disorders undergoing hla-incompatible allogeneic haematopoietic stem cell transplantation between 15 and 60 years-old must sign the informed consent exclusion criteria: withdraw of the signed informed consent for any reason lack of ability to provide consent due to psychiatric or physical illness
a trial of shr0410 injection for the treatment of pain after laparoscopic surgery

Conditions: Postoperative Pain Of Laparoscopic Surgery

Summary: the study is being conducted to evaluate the efficacy and safety of shr0410 injection for the treatment of pain after laparoscopic surgery


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. subjects requiring elective general anesthesia endoscopic surgery of the lower abdominal 3. male or female 4. meet the body mass index standard 5. conform to the asa physical status classification exclusion criteria: 1. subjects with a history of difficult airway 2. subjects with a history of mental illness 3. subjects with a history of cognitive impairment epilepsy 4. subjects with a history of myocardial infarction or unstable angina pectoris 5. subjects with atrioventricular block or cardiac insufficiency 6. subjects with a history of ischemic stroke or transient ischemic attack 7. subjects with poor blood pressure control after medication 8. subject with a history of substance abuse and drug abuse 9. abnormal values in liver function 10. allergic to drugs that may be used during the study 11. pregnant or nursing women 12. no birth control during the specified period of time 13. participated in clinical trials of other drugs (received experimental drugs) 14. the investigators determined that other conditions were inappropriate for participation in this clinical trial
spinal stimulation for chronic complete tetraplegia

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is investigate the acceptability and effectiveness of transcutaneous spinal cord stimulation in people with complete high level spinal cord injury.


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent for participation in the study * aged ≥18 years * injury level c3-c7, american spinal cord injury association impairment scale (asia) a * ≥1 year post-injury * medically stable, cognitively intact, and able to breathe independently * able to attend all sessions two or three times per week, for 2 h sessions and assessments exclusion criteria: * any implanted active metallic device including, but not limited to neurostimulators, cochlear implants, pacemakers, implantable defibrillators, or drug delivery pumps * possible, suspected, or confirmed pregnancy and/or lactation * recent history or fracture, contractures or pressure sore, deep vein thrombosis (dvt) or urinary tract, or other infection that may interfere with the intervention and training * history of epilepsy and/or seizures * severe spasticity which has been unstable over the 3 months prior to enrolment and is not expected to change and/or taking varying doses of anti-spasticity medications which could not be tapered to a stable dose and are not expected to change * botulinum toxin injections within 6 months of participation * non-injury related neurological impairment * clinically significant severe depression in spite of treatment * cardiovascular disease * autonomic dysreflexia that is severe, ongoing, and has required medical treatment within the past month * skin conditions or allergies that may affect electrode placement * do not understand english * received a stem cell treatment or other treatment that could possibly promote or attenuate neuroplastic changes in spinal or cortical function, within ≥2 years of enrolment; beyond this period, they may be included, provided the treatment was conducted in an accredited facility with proper ethics and regulatory approval. * involved in any other study involving stimulation of the spinal cord within 6 months of enrolment * information regarding recent rehabilitation or exercise programmes that participants may currently be engaged in will be discussed with clinical staff and fully documented for each participant
effects of blueberry dry powder on glycemic status in subjects with prediabetes

Conditions: Prediabetes

Summary: the purpose of the present study is to evaluate the effect of blueberry dry powder on glycemic status (fasting plasma glucose, 2h glucose concentration after the oral glucose tolerance test (ogtt), or hba1c) in subjects with prediabetes.


Eligibility criteria:
inclusion criteria: * fasting plasma glucose 110-125 mg/dl exclusion criteria: * taking anti-diabetic drugs * taking drugs or functional food that may affect blood glucose level * fruit allergy * pregnant or nursing a child * participation in any clinical trial within 90 days of the commencement of the trial * renal or hepatic dysfunction * heart disease
single photon emission computed tomography (spect) lymph node mapping

Conditions: Adenocarcinoma of the Prostate

Summary: the purpose of this study is to determine if the planning of radiation treatment of prostate cancer patient can be made more precise by comparing currently planning techniques to an imaging technique called spect.

single photon emission computed tomography (spect) uses radioactive tracers and a scanner to record data that a computer constructs into two- or three-dimensional images. a small amount of a radioactive drug is injected into the body and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. using a gamma camera (a special kind of scanner), we can create a better picture of the lymph node region. we will compare these pictures to images from your ct scan, to help plan your therapy. the research in this study involves seeing if it is feasible to use spect scanning procedures for the purpose of planning your radiation treatment. we hope that doing so will allow us to more accurately and precisely plan radiation treatment to potential sites of cancer, and avoid delivering too much radiation to normal

Eligibility criteria:
inclusion criteria: * patients with biopsy proven adenocarcinoma of the prostate * patients with at least one of the following high risk clinical features at the time of presentation: * extra-prostatic extension (on palpation or radiographic imaging) * psa ≥ 20 * gleason score ≥ 8 * patients scheduled to receive prostatic and pelvic imrt with acculoc® target localization * age \> 18 years * ecog performance status ≤ 2 * willing and able to sign informed consent document.- exclusion criteria: * history of radical prostatectomy * history of prior pelvic radiation-

Keywords: spect
validation of a tolerability questionnaire in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of the present study is to assess the measurement properties of a tolerability questionnaire. the results obtained in patients with rheumatoid arthritis (ra) being treated will be robust and will assess the patient's tolerability to the treatment. patients with greater tolerability will be more satisfied with their treatment.

clinicians do not have any standardized questionnaire to assess the tolerability from the patient's perspective. the tolerability assessment of the different pharmacological strategies for rheumatoid arthritis, from the patient's perspective, would provide additional information, improve doctor-patient communication and improve both adherence to and efficacy of treatment. for these reasons, the development and validation of a new tool is necessary not only for future researches, but for use in standard clinical practice. the first phase of the development of the questionnaire has already been completed. the second phase of the development of the questionnaire has been designed at to validate the tool in the spanish population. this study aims to assess the measurement properties of a new tool which assesses the impact of daily life in rheumatoid arthritis.

Eligibility criteria:
inclusion criteria: 1. patients over 18 years old. 2. patients with ra diagnosed according to the standards of the acr (american college of rheumatology) in 1987 or to the acr/eular in 2010 3. patients on treatment with any rheumatoid arthritis drug for at least 3 months before their inclusion in the study \* 4. patients who have provided informed consent prior to taking part in the study. * it's not necessary for patients to be treated in first-line at the moment of the inclusion in the study. exclusion criteria: 1. patients with rheumatic disease other than rheumatoid arthritis. will be exclude patients with the following concomitant diseases: rheumatic autoimmune disease other than ra; functional class iv as defined by the acr classification of functional status in rheumatoid arthritis; diagnosis of juvenile idiopathic arthritis; inflammatory joint disease other than rheumatoid arthritis. 2. patients with any other concomitant disease or treatment that, under clinical criteria, could affect the results of the study or any major episode of infection or disease requiring hospitalization. 3. patients with any other medical or physiological condition that, in the view of the investigator, could compromise the ability of the patient to answer the study questions. 4. patients who participated in interviews of the phase i (development of the questionnaire)

Keywords: ar: arthritis rheumatoid dmards: disease-modifying antirheumatic drugs acr. american college of rheumatology eular: european league against rheumatology
study of fluoxetine in autism

Conditions: Autistic Disorder

Summary: the purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (odt) on the repetitive behaviors core domain in children and adolescents with autistic disorder. the study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily living of the patient's family.


Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for autistic disorder, . * cybocs-pdd score of at least 10 at screening. exclusion criteria: * diagnosis of asperger syndrome or pervasive developmental disorder not otherwise specified, rett syndrome, childhood disintegrative disorder. * patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment. * patients who are currently taking fluoxetine or who have previously taken it are not eligible for the study. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: autism children adolescent fluoxetine autistic disorder repetitive behavior ssri selective serotonin reuptake inhibitor