Kornimate/medical-research-clean huggingface dataset:
therapeutic drug monitoring of risankizumab in psoriasis patients (bioloptim-ris)

Conditions: Psoriasis Vulgaris

Summary: biologics such as risankizumab are currently the most effective treatment option for patients with moderate to severe psoriasis. but they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over-and undertreatment. in this study the investigators aim to investigate the predictive value of early serum trough levels of risankizumab and determine the therapeutic window of risankizumab in psoriasis patients.

patients will be included after signing informed consent. after inclusion, patients will continue on standard dosing schedule of risankizumab (i.e. subcutaneous injections at weeks 0 and 4, then every 12 weeks (2x 75mg)). during each study visit blood will be taken in order to quantify ctroughs and/or anti-drug antibodies towards risankizumab. in addition, psoriasis area and severity index (pasi) and investigator's global assessment (iga) score will be evaluated by a physician. patients complete the dermatology life quality index (dlqi) and european quality of life eq-5d instrument at each visit.

Eligibility criteria:
inclusion criteria: * participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis * participants must sign an icf indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. exclusion criteria: * participants who have currently a predominant nonplaque form of psoriasis * participants who are pregnant, nursing or planning a pregnancy * participants who are unable or unwilling to undergo multiple venapunctures * participants who are treated according to a different dosing schedule than standard dosing of risankizumab

Keywords: therapeutic drug monitoring psoriasis risankizumab
automated telephone system to improve treatment adherence in people with depression

Conditions: Depression

Summary: this study will determine the efficacy of a computerized telephone system called telephone-linked care (tlc) in improving adherence to antidepressant medication regimens in people with depression.

the purpose of this study is to test the efficacy of a computerized telephone system called tlc (telephone-linked care) in helping subjects adhere to their antidepressant medication regimens.

Eligibility criteria:
inclusion criteria: * a clinical diagnosis of major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified, or any combination of the three * prescribed at least one antidepressant medication * access to a telephone with touch-tone service * speak and understand conversational english exclusion criteria: * current significant alcohol or drug abuse * clinical diagnosis of bipolar disorder, schizoaffective disorder, or significant personality disorder * parkinson's disease, huntington's disease, amyotrophic lateral sclerosis (als), or other neurodegenerative diseases * alzheimer's disease and other dementia * cancer, undergoing radiation therapy or chemotherapy * suffering from renal disease or on dialysis * immunologic disorder (rheumatoid arthritis, systemic lupus erythematosus \[sle\], etc.) * hiv * terminal illness * homeless * legally blind * planning to leave the geographic area during the study period
stroke motor rehabilitation and recovery study

Conditions: Stroke, Ischemic

Summary: smahrt (stroke motor rehabiliation and recovery study) is a longitudinal study aimed at understanding the natural history of upper extremity motor recovery after ischemic and hemorrhagic stroke.

participants will be enrolled in the smahrt study during their acute stroke hospitalization and will have research visits spanning the post-stroke care continuum at approximately 6 weeks, 3 months, 6 months, one year, two years, and three years after stroke. the study will collect demographics and clinical outcome measures, clinical neuroimages, video and robot-kinematic data and neurophysiology data through tms and eeg in order to quantify the course of motor recovery. the research visits may be accompanied by a comprehensive clinical visit to the massachusetts general hospital neurorecovery clinic. the goal is to understand the behavioral, neuroanatomic, and neurophysiologic underpinnings of motor recovery toward developing personalized strategies and neurotechnologies to facilitate neurorehabilitation and enable better recovery for people with stroke.

Eligibility criteria:
inclusion criteria * age 18 - 90 * upper extremity motor weakness after ischemic and/or hemorrhagic stroke as defined by a score of \>=1 on nih stroke scale arm motor drift questions 5a or 5b * ability to follow simple commands in english * score of zero or 1 on the nih stroke scale level of consciousness questions 1a and 1b and a score of zero on the nih stroke scale level of consciousness question 1c. * stable medical status as determined by primary care team * inpatient on the mgh stroke neurology service exclusion criteria * prior history of developmental, neurologic, or major psychiatric disorder resulting in functional disability * prior history of visual or auditory disorders limiting ability to participate in testing * evidence of an uncontrolled seizure disorder * patients for whom eeg leads are contraindicated

Keywords: rehabilitation neurorehabilitation neurotechnology neurorecovery neurorestoration
exercise training in patients with rheumatoid arthritis and cryotherapy

Conditions: Arthritis, Rheumatoid

Summary: the main objective of this project is to study, in patients with rheumatoid arthritis, the effects of an intermittent type exercise associated with cryotherapy on the level of inflammation during its recovery.


Eligibility criteria:
inclusion criteria: * men and women \>18 years old, \< 80 years old * signature of informed consent for participation * affiliation to a social security scheme or french beneficiary of such a regime. * confirmed rheumatoid arthritis and monitoring by the rheumatology department of the university hospital of besancon. * if there is a corticosteroid therapy, it must be stable for at least 1 month and less than or equal to 10 mg of prednisone equivalent per day * clinical and biological activity will be moderate (ie not in remission and not severe based on disease activity score 28 joints - das 28 - to be between 2 and 6 * patients could be treated with dmards (disease-modifying drugs). exclusion criteria: * patient under guardianship, curatorship, under judicial protection, major incapable * patients whose body mass index (bmi) greater than 30, * pathology incompatible with the completion of a cycle ergometer exercise (heart, vascular, respiratory, orthopedic ...) * change in das28 greater than 1.2 in the previous 3 months inclusion * a patient with a das28 \> 6 * about the cold: raynaud's syndrome, cold known allergy, sickle cell anemia, cryoglobulinemia, uncontrolled hypertension * patient unable to follow protocol because of cognitive, psychiatric or language difficulties. * inability to follow protocol for causes related to health problems (unrelated rheumatoid arthritis) or socio-professional.
montelukast in patients with seasonal allergic rhinitis - spring 2000 study (mk-0476a-162)(completed)

Conditions: Seasonal Allergic Rhinitis

Summary: this study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.


Eligibility criteria:
inclusion criteria: * patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season * patient is a nonsmoker and has been a nonsmoker for at least 1 year * patient is in good general health exclusion criteria: * patient is hospitalized * patient is a woman who is less than 8 weeks postpartum or is breast-feeding * patient intends to move or vacation away during the study * patient has had any major surgery within 4 weeks of study start * patient is a current or past abuser of alcohol or illicit drugs * patient has been treated in an emergency room for asthma in the past month * patient had an upper respiratory infection with in 3 weeks prior to study start
study of map0010 in asthmatic children and adolescents

Conditions: Asthma

Summary: the objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of map0010 (unit dose budesonide) in asthmatic children/adolescents.


Eligibility criteria:
inclusion criteria: * male or female asthmatic children/adolescents * 1 to 18 years of age * fev1 greater than or equal to 50% predicted normal (where obtainable) * stable but symptomatic * diagnosis of asthma (per nih criteria) at least 3 months before screening or documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening or documented sab use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 or greater than or equal to 1 night disturbed due to asthma symptoms in previous month. exclusion criteria: * any other significant childhood illness. * participated in any investigational clinical trial within the 30 days prior to screening. * use of any corticosteroid within 2 weeks of screening. * use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening. * use of inhaled long acting bronchodilators. * presumptive or documented history of upper or lower respiratory infection within 2 weeks before screening. * any history of acute or severe asthma attack requiring icu admission or ventilatory support. * history suggestive (or diagnosis) of other concomitant lung disease.
a study to evaluate the safety and pharmacokinetics of cntx-6016 in healthy subjects

Conditions: Chronic Pain; Nociceptive Pain; Pain

Summary: a phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.


Eligibility criteria:
key inclusion criteria: * is in good general health as determined by investigator's review. * has a body mass index (bmi) between 18 and 35 kg/m2. * non- or ex-smoker (\> 1 year) and has not used any nicotine containing products within 12 months prior to screening. * for females, is not currently pregnant and is either of non-childbearing potential or willing to use an adequate method of birth control. * for males, must agree to use barrier contraception and not to donate sperm. key exclusion criteria: * history of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia. * has any history or currently active type of cancer except excised or cured basal cell carcinoma. * has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs. * has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine. * currently has kidney, neurologic, metabolic, or liver disease, or other organ system disease. * has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment. * has an immunological disorder such as, but not limited to, human immunodeficiency virus (hiv), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection. * has positive screening test for hepatitis b virus (hbv) or hepatitis c virus (hcv). * is pregnant, lactating, or planning a pregnancy during the study. * has used any prescribed medication within 30 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives). * positive urine screen for alcohol, cotinine, thc and/or drugs of abuse. * ingestion of food or beverages containing grapefruit and/or grapefruit juice and/or pomelos during the 7 days prior to dosing and/or during the study period.

Keywords: chronic pain nociceptive pain mixed pain cannabinoid cannabinoid-2 receptor agonist
effect of opioids in neuropathic pain in postherpetic patients

Conditions: Neuralgia, Postherpetic

Summary: postherpetic neuralgia (phn) is often associated with pain and sensory changes and is the leading type of neuropathic pain in modern clinical pain research. it is characterized by a variety of sensory patterns, which may be categorized into "irritable nociceptor" and "impairment of nociceptor". at date, several lines of evidence lead to the assumption, that mechanical hyperalgesia in phn is based - at least in part - on central nervous processes of sensitization. in animal studies the investigators have discovered a previously unrecognized effect of opioids, the reversal of long-term potentiation (ltp) at c-fibre synapses, i.e. an opioid-induced depotentiation. in principle, synaptic depotentiation may be permanent or transient. in our study the clinically used ultra-short acting mor agonist remifentanil normalized synaptic strength after wash-out of the drug. at present it is not known whether opioid-induced depotentiation can be used to the benefit of pain patients. the aim is to study the hypothesis, that pain in a group of phn patients with predominant mechanical hyperalgesia is reversed by intravenous remifentanil at a plasma target concentration of 18ng/ml (corresponding to about 0.75 µg/kg/min) for 60 minutes compared with phn patients of other sensory types.


Eligibility criteria:
inclusion criteria: * patients suffering from phn. * pain ≥ 4 out of 10 in numeric rating scale (nrs) * female and male patients above the age of 18 * ability to understand/write/read german exclusion criteria: * zoster affecting trigeminal-, opticus region * any somatic pain which is stronger than the neuropathic pain * severe progressive disease * acute cardiac decompensation * known cardiac valve dysfunction * known pulmonary hypertension * cardiac conduction disturbance * active herpetic lesion * opioid therapy * asthma bronchial * chronic obstructive pulmonary disease \>gold ii * severe psychiatric condition * abuse of alcoholic beverages, drug abuse * negative neuropathic symptoms * pregnancy or breast feeding * participation in a clinical trial in the 2 weeks preceding the study * allergy against any medication used in the study protocol

Keywords: remifentanil hyperalgesia zoster postherpetic neuralgia
ebus-tbna vs transbronchial mediastinal cryobiopsy for adequacy of next generation sequencing

Conditions: Lung Cancer

Summary: this is a multi-center clinical trial evaluating the effect of transbronchial mediastinal cryobiopsy for its ability to improve the likelihood of obtaining tissue sufficient for molecular analysis. patients in outpatient clinics or pre-operative holding areas planning to undergo a bronchoscopic biopsy of a suspected malignant lesion (peripheral or mediastinal) for initial diagnosis, staging, or tissue acquisition for molecular analysis will be considered for enrollment and consented. patients will only be enrolled if intraoperative rose suggests malignancy. patients will be randomized to continue with the operator's initial ebus-tbna needle or switch to a cryoprobe to perform a sampling.

primary objective: - to evaluate the utility of transbronchial mediastinal cryobiopsy on its ability to improve the likelihood of acquiring tissue sufficient for next-generation sequencing (ngs). safety endpoints: * pneumothorax within 7 days of procedure * moderate bleeding defined as controlled with bronchoscope, saline, or epinephrine * serious bleeding is defined as uncontrolled, leading to respiratory failure, need for transfusion, or cardiovascular instability * respiratory failure is defined as a new oxygen requirement or escalation in oxygen delivery within 7 days of procedure * unplanned hospitalization related to the procedure within 7 days of procedure * death exploratory endpoints: * the proportion of samples adequate for ngs testing * the proportion of samples with adequate pd-1 / pd-l1 immunohistochemical staining * proportion of samples that are adequate for complete ngs library sequencing * estimated total number of tumor cells per h\&e-stained slide * histological disease subtyping

Eligibility criteria:
inclusion criteria: * lesions on pet or ct concerning for primary or metastatic malignancy that are amenable to biopsy by linear ebus * malignant cells present on rapid on-site cytological evaluation (rose) exclusion criteria: * patient is known to be less than 18 years old * patient is known to be pregnant * patient is known to be a prisoner * operator deems lesion is not safe to biopsy
mindfulness intervention for individuals with hiv and chronic pain

Conditions: Chronic Pain; HIV Infections

Summary: this project is a single-site, two-arm, randomized controlled pilot study examining the impact of a 2-hour version of mindfulness-oriented recovery enhancement (one more) training for individuals with hiv and chronic pain.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic pain * be hiv+ * 18 years of age or older * fluent english speaker * will commit to try no other new treatments during study duration exclusion criteria: * not having hiv * being unable to follow tasks due to pain level * prior mindfulness training
real-life multicentre survey evaluating stroke prevention strategies (ramses)

Conditions: Thrombotic Stroke; Atrial Fibrillation and Flutter

Summary: the aim of this study is to evaluate the present status of stroke prevention strategies in patients with non-valvular atrial fibrillation (nvaf). vitamin k antagonists (vkas) have been the only available oral anticoagulant therapy for decades. recently novel oral anticoagulants have emerged as an alternative for vkas. this study is planned to evaluate the epidemiological characteristics, thromboembolic and bleeding risks, stroke prevention strategies and appropriateness of oral anticoagulant use in nvaf patients. time in therapeutic range (ttr) is going to be calculated as the percent of visits in range (2-3) for warfarin patients. this is a national multicenter observational study in which turkey is divided into seven regions. a proportional number of patients to the population of every region is planned to be included.

atrial fibrillation (af), classified as nonvalvular (nvaf) in the absence of rheumatic mitral stenosis or valvular prosthesis,is the most common arrhythmia, with an estimated prevalence of 1.5-2%. af is associated with a greater risk of arterial thromboembolic events, especially cerebrovascular, whose incidence is 5-7 times higher. the risk of death is also doubled, and af has a greater degree of disability and probability of recurrence than stroke due to other causes. to prevent stroke in patients with nvaf, antithrombotic treatments are employed with oral anticoagulants such as vitamin k antagonists (vka) and, in a number of circumstances, antiplatelet agents. although vka (mainly warfarin) are highly effective to reduce the risk of stroke, and have been the sole choice for stroke prevention during the last 50 years, their use is limited for a number of reasons: narrow therapeutic range, drug and food interactions, need for monitoring, and risk of bleeding. recently, new oral anticoagulants (noacs) have been marketed for this indication. the aim of this study was to determine the standard clinical practice followed in the treatment to prevent stroke in patients with nvaf in turkey. the purpose of this study is to demonstrate the current status of the clinical background of af patients and to follow, analyze and evaluate patients with af in a large multicenter nation-wide trial. the primary inclusion criteria will be age ≥18 years and with electrocardiographically confirmed nvaf (eg, by electrocardiogram, holter monitoring, etc). the enrollment of patients will be started in february 2014. all the participating institutions will enroll all consecutive patients with nvaf under regular outpatient care or under admission.

Eligibility criteria:
inclusion criteria: * atrial fibrillation exclusion criteria: * valvular heart disease (mitral stenosis, prosthetic heart valves, heart valve surgery)

Keywords: non-valvular atrial fibrillation stroke prevention novel oral anticoagulants warfarin
red cell distribution width as a predictor of mortality in acute methanol poisoning

Conditions: Methanol Poisoning

Summary: the study aimed to investigate the association between rdw and in-hospital mortality in methanol poisoning.

rdw values have been found to be an independent predictor of the prognosis among patients with heart diseases, stroke,community-acquired pneumonia (cap), pulmonary embolism, chronic obstructive pulmonary disease (copd), septic shock, and acute pancreatitis.

Eligibility criteria:
inclusion criteria: all patients aged ≥18 years who were admitted to emergency departments from january 2019 to january 2020 on account of acute methanol intoxication. exclusion criteria: incomplete data, malignancy, severe anaemia, history of erythrocyte transfusion last 6 weeks -

Keywords: alcohol, red blood cell distribution width, methanol poisoning, prognosis