Kornimate/medical-research-clean huggingface dataset:
a pharmacokinetic study of levodopa and carbidopa intestinal gel in subjects with advanced parkinson's disease

Conditions: Parkinson Disease

Summary: a pharmacokinetic study of levodopa and carbidopa intestinal gel in subjects with advanced parkinson's disease.


Eligibility criteria:
inclusion criteria 1. male or female subjects at least 30 years old; 2. subjects with advanced parkinson's disease who are already on lcig (duodopa®) for at least 30 days; 3. body mass index range from 18.0 to 30.0 kg/m2 exclusion criteria 1. subjects who are considered to be violent or subjects considered at suicidal risk by the investigator; 2. clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments; 3. subjects with serious symptomatic cerebral disease, cerebrovascular disease, focal neurological lesions (previous brain surgery), any acute brain trauma requiring treatment with anticonvulsant therapy, or acute stroke

Keywords: parkinson's disease levodopa carbidopa duodopa intestinal gel
study of efficacy, safety, and tolerability of lys006, in patients with mild to moderate ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of the study was to assess preliminary efficacy, safety, and tolerability of lys006 in adult patients with mild to moderate ulcerative colitis and to determine if lys006 has an adequate clinical profile for further development in this indication.

this was a randomized, placebo-controlled, subject and investigator blinded, multicenter, non-confirmatory, parallel group, proof of concept study in patients with mild to moderate ulcerative colitis. this study consisted of a screening period of up to 4 weeks, and a 8 week treatment period followed by a 30 day post treatment period safety follow up. the maximum study duration for each participant including the 4 week screening period was 16 weeks. at the beginning of the treatment period, subjects were randomized to one of the two following treatment groups in 2:1 ratio * lys006 * matching placebo

Eligibility criteria:
key inclusion criteria: * male and female subjects 18-75 years of age with an established diagnosis of ulcerative colitis at least 3 months prior to screening are eligible for the study. * patients must have active disease with a full mayo score between 5 and 10 (inclusive) with an endoscopy score of 2 or 3; rectal bleeding and stool frequency scores 1 to 3 and a physician's global assessment of 1 or 2. * patients must have responded inadequately to conventional therapy with oral 5-asa prior to screening. key exclusion criteria: * has previous diagnosis with crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history. * history of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma; history or is at risk of colectomy. * treatment with biologics within 3 months or 5 half-lives (whichever is longer) prior to screening endoscopy, non-biologics advanced therapies within 4 weeks prior to screening endoscopy, systemic immunosuppressant or immunomodulator within 6 week, topical treatment with 5-asa or steroids within 2 weeks prior to screening endoscopy

Keywords: ulcerative colitis, efficacy, safety
treatment of aspergillus fumigatus (a fungal infection) in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this clinical trial will attempt to determine whether we can improve clinical outcomes for patients with cystic fibrosis who are infected with a fungus called aspergillus fumigatus.

the aim of this study is to determine whether antibiotic treatment directed against aspergillus fumigatus will be effective at preventing respiratory exacerbations and improving pulmonary function in patients with cystic fibrosis(cf) who are chronically colonized/infected with aspergillus. this aim will be accompanied by means of a randomized, double-blind, placebo-controlled clinical trial incorporating two parallel treatment arms.

Eligibility criteria:
inclusion criteria * diagnosis of cf as defined by two or more clinical features of cf and a documented sweat chloride greater than 60 meq/l by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations * patient must be known to be chronically colonized with aspergillus fumigatus. * patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization. * 6 years of age and older * patients must weigh at least 20 kg * post-menarche females must be using an effective form of contraception. exclusion criteria * inability to give informed consent. * respiratory culture positive for b.cepacia complex * renal function abnormalities-creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization * liver function abnormalities : ast or alt greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization * neutropenia, absolute neutrophil count\&lt; or = 1000 within a 3-day period prior to randomization * history of biliary cirrhosis documented by liver biopsy or imaging. * history of portal hypertension. * investigational drug use within 30 days of randomization date. * history of alcohol, illicit drug or medication abuse within 1 year of randomization. * women who are pregnant, breastfeeding or trying to conceive

Keywords: cystic fibrosis aspergillus fumigatus randomized controlled clinical trials
real life use of omalizumab in chronic urticaria

Conditions: Chronic Urticaria

Summary: chronic urticaria affects up to 1% of the population. chronic urticaria refractory to updosing antihistamines can benefit from omalizumab, which is an anti-ige igg1 monoclonal antibody administrated every 4 weeks subcutaneously which represents a cost of nearly 800€/month excluding nurse fees. efficacy and good tolerance have already been demonstrated in real-life large cohorts of patients. a 6 months treatment duration is proposed before evaluating the efficacy and discontinuating the treatment in the absence of adequate response. mean duration of chronic urticaria is 3 to 5 years with high standard deviations. therefore, optimal duration of treatment with omalizumab is unknown and discontinuation modalities differ between physicians. the aim of this study is to evaluate the mean duration between initiation and first discontinuation of omalizumab in patients treated for chronic urticaria and explore the different factors influencing this duration and its outcome.

chronic urticaria affects up to 1% of the population. rarely, chronic urticaria may be refractory to updosing four-fold antihistamine drugs and then can be improved with subcutaneous omalizumab. omalizumab is available for chronic urticaria since 2015. it is an igg1 monoclonal antibody targeting ige and administrated every 4 weeks which represent a cost of nearly 800€/month excluding nurse fees. efficacy and good tolerance have already been demonstrated in real-life large cohorts of patients. a 6 months treatment duration is proposed before evaluating the efficacy and discontinuating the treatment in the absence of adequate response. mean duration of chronic urticaria is 3 to 5 yearss with high standard deviations. therefore, optimal duration of treatment with omalizumab is unknown and discontinuation modalities differ between physicians. the aim of this study is to evaluate the mean duration between initiation and first discontinuation of omalizumab in patients treated for chronic urticaria and explore the different factors influencing this duration and its outcome. to accomplish this, the investigators will conduct a restrospective analyse of all patients treated with omalizumab for chronic urticaria from 2010 to 2020 in the major french hospital reference centers for chronic urticaria management : paris, lyon, grenoble, lille, bordeaux, nantes, rouen, saint-etienne, montpellier.

Eligibility criteria:
inclusion criteria: * chronic spontaneous or inducible urticaria * treated with omalizumab * at least once between january the 1st 2010 and july 2020. exclusion criteria: * unknown intiation and discontinuation date of omalizumab * omalizumab initiated for asthma * other diagnosis (vascularitis, aquagenic pruritus)

Keywords: chronic urticaria treated with omalizumab
a cognitive behavioral therapy intervention for internet gaming disorder

Conditions: Internet Gaming Disorder

Summary: this rct study develops a brief group-based cbt intervention. the primary objective is to evaluate the efficacy of the cbt in reducing igd, compare to a wait-list control group.

introduction cognitive behavioral therapy (cbt) is potentially useful as it is effective in treating mental/behavioral disorders, restructuring cognitions and cultivating positive coping. a gap exists as the only two existing clinic-based small randomized controlled trials (rct) yielded mixed findings on cbt's treatment effect for adolescent igd. objectives this rct study develops a brief group-based cbt intervention. the primary objective is to evaluate the efficacy of the cbt in reducing igd, compare to a wait-list control group. subjects and methods the study design is two-armed rct. the participants are secondary 1-4 students (n=226) with igd (dsm-5 classification) identified in a school-based screening. evaluation involves surveys at baseline, end of cbt intervention, and 6 months afterwards. in addition to information received by the wait-list control group, the intervention group receives a carefully designed brief 8-week group-based cbt. the control group will receive cbt after the 6-month follow-up. trained social workers of a collaborating ngo that serves secondary school students will conduct the cbt. outcomes and measures the primary outcome is igd (a validated dsm-5 igd classification tool). secondary outcomes include time spent on internet/internet games and the intention to reduce igd. measures of potential mediators (maladaptive beliefs and coping) include: internet gaming cognition scale, generalized problematic internet use scale, emotion regulation questionnaire, and coping scale for children and youth. data analysis intention-to-treat analysis is performed. the primary outcome is assessed by absolute and relative risk reduction. generalized linear mixed models and structural equation models are used to test secondary outcomes and mediation effects. implications the findings may lead to an evidence-based treatment for adolescent igd, a newly defined disease, which has been rarely reported in literature. understanding its mechanism contributes to theoretical development of igd and related treatment.

Eligibility criteria:
inclusion criteria: * secondary 1-4 students (grade 7-10), * positive screening results (i.e. igd cases) according to a validated questionnaire (the 5 dsm-5 criteria for igd), * students' and parental consent, * chinese speaking. exclusion criteria: * self-reported history of any psychiatric or neurological illness, * current use of any psychotropic medication. we do not include secondary 5-6 students due to their preparation for public examinations and practical difficulty in follow-up after their graduation.
role of inflammation factors and insulin resistance in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to identify evidence-based guidelines for treating major depressive disorder to full remission in taiwanese major depressive disorder (mdd) patients. to achieve this goal, the investigators aim to: (1) evaluate the risks and benefits of adjunctive pharmacotherapies for cognitive and metabolic consequences in mdd, and (2) clarify the shared biological mechanisms between mood, immune and metabolism homeostasis

the prevalence of insulin resistance did not significantly differ among the healthy controls and drug-naïve mdd patients before and after antidepressant treatment. meanwhile, the current study indicated that antidepressants might affect insulin secretion independently of the therapeutic effects on mdd. therapeutic strategies considering both treatment effectiveness and glucose-insulin homeostasis in mdd patients are necessary.

Eligibility criteria:
inclusion criteria: * age: 16-65 years old * signed informed consent by patient or legal representative * hamilton rating scale for depression (hdrs) scores ≥ 16 * a diagnosis of mdd according to dsm-iv criteria made by a specialist in psychiatry exclusion criteria: * monoamine oxidase inhibitor or antidepressant treatment prior to entering the study * a dsm-iv diagnosis of substance abuse within the past three months * an organic mental disease, mental retardation or dementia * a serious surgical condition or physical illness * patients who were pregnant or breastfeeding

Keywords: major depressive disorder antidepressants insulin fluoxetine
physical activity levels and functional improvement in breast cancer survivors

Conditions: Breast Cancer

Summary: the main objective of our project is to describe what characteristics (e.g., age, current physical activity level) women present when starting the exercise program are potentially associated with an improvement in functional abilities measured with different tests such as the distance you can cover while walking for six minutes.

the main research objective is to investigate the relationship between baseline physical activity and improvement in physical function, quantified using changes in 6-minute walk test (6mwt) results over the course of the 12-week program. an association is hypothesized to exist between the two variables even when adjusted for weeks into treatment. the goal of the 6mwt is to cover as much distance as possible in six minutes, using as many breaks s necessary. the test is often performed using a 20-meter hallway but requires no specific equipment. a recent study reported that the result of the 6mwt could be used as a measure of the major components of global health in women with breast cancer, making its use in our research especially relevant. aside from physical functions, baseline characteristics will also be used to determine what characteristics, if any, are associated with health and psychosocial outcomes such as quality of life, social connectedness/support, and mental well-being. the data collected is certain to fill a gap in the literature, and will therefore be likely published in an important journal in the field.

Eligibility criteria:
inclusion criteria: * have received a diagnosis of breast cancer in your lifetime * 19 years of age and older * cleared by medical team to participate in the study * have the intention to exercise at the facility for the duration of the study exclusion criteria: -
dm1, effects of carbo-counting on glycemic control

Conditions: Type 1 Diabetes Mellitus

Summary: carbohydrate counting is the most effective meal-planning strategy in type 1 diabetes (t1dm) to optimize insulin therapy. however, it may lead to weight gain and unhealthy eating habits. this study aims to compare glycemic control parameters, anthropometric measurements and dietary lifestyle in t1dm patients who practice cho-counting, after attending a structured course to learn how to manage this tecnique, vs a control group, in a follow up period of 2 years.

patients with type 1 dm will be enrolled in the study. patients in the intervention group will attend a 5-lessons training to learn how to manage insulin therapy depending on the amount of carbohydrates in their meals, patients in the control group will be follow according to the the standard care. after the follow up period glycometabolic, anthropometric parameters and dietary lifestyle changes will be compared between the two groups.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * insulin therapy * hba1c from 5.5 to 10% exclusion criteria: * pregnancy * celiac disease * hepatic impairment * chronic renal failure

Keywords: carbohydrate counting insulin therapy
detection and characterization of lower respiratory infections in critically ill patients

Conditions: Severe Pneumonia

Summary: this study is a prospective observation study for lower respiratory tract infections in medical intensive care unit. microbiologic and clinical characteristics and outcomes of patients with severe pneumonia in medical intensive care unit will be monitored and analyzed.

all patients admitting medical icu will be monitored for pneumonia. both community-acquired (including health-care associated pneumonia) and hospital-acquired pneumonia will be included. collecting data will include patient demographic characteristics, clinical features, microbiological characteristics including molecular work, and outcome.

Eligibility criteria:
inclusion criteria: * patients admitting medical icu with pneumonia * medical icu admitted patients who is developed new pneumonia exclusion criteria: * patients already treated more than 48 hours for pneumonia in transferring hospital and no causative organism is isolated

Keywords: pneumonia
prevalence of obstructive sleep apnea (osa) and the association with cognitive impairment

Conditions: Obstructive Sleep Apnea; Cognitive Impairment

Summary: the study is aimed to carry out an epidemiology study investigating the prevalence of obstructive sleep apnea (osa) and the association with cognitive impairment.


Eligibility criteria:
inclusion criteria: * have stability of at least 4 weeks on permitted medications (i.e. medications known not to affect sleep architecture or circadian rhythms). exclusion criteria: * suspected dementia or a score of \<24 on the mini-mental state examination * a diagnosis of neurological disorders (e.g. parkinson's disease, epilepsy, multiple sclerosis) * psychiatric disorders including current major depression; bipolar disorder; schizophrenia * other known clinically significant sleep disorders (e.g. narcolepsy) * been currently receiving cpap or bi-level pressure for osa
positive predictive value (ppv) of pseudomonas aeruginosa

Conditions: Wound; Chronic Leg Ulcer; Wound Contamination

Summary: this is a non-randomized, single-blind post market clinical follow-up study for which 65 patients will be imaged at rouge valley centenary hospital (scarborough and rouge hospital) who present with a chronic wound and are receiving standard wound care treatment. the moleculight i:x imaging device will be used by the study clinician as an adjunctive tool in the assessment of the wound and will be used to guide the targeted sampling of a wound (with curettage scraping), as per current standard of care in the principal investigator's wound care clinic. the acquired tissue sample will then be analysed using conventional gold standard semi-quantitative culture methods to determine bacterial species present, also as per current standard of care in this clinic.


Eligibility criteria:
inclusion criteria: 1. male or female patients presenting with a chronic wound (wound duration \> 4 weeks) e.g. diabetic foot ulcer, venous leg ulcer, pressure ulcer, or other acceptable aetiology 2. 18 years or older exclusion criteria: 1. treatment with an investigational drug within 1 month before study enrolment 2. inability to consent to medical photography (i.e. inability to understand consent process) 3. any contra-indication to routine wound care and/or monitoring 4. prior participation of the patient in this study (for the same wound or a different wound).
special investigation in patients with intestinal behcet's disease (all case investigation)

Conditions: Behcet's Disease

Summary: this investigation was conducted to obtain the following information regarding the use of adalimumab (humira®) 40mg syringe 0.8ml for subcutaneous injection in patients with intestinal behcet's disease. 1. incidence and conditions of occurrence of adverse reactions in clinical practice 2. factors likely to affect the safety and effectiveness


Eligibility criteria:
inclusion criteria: * all patients who received adalimumab for the treatment of intestinal behcet's disease (not sufficiently responsive to existing therapies, e.g. steroids, immunomodulator) exclusion criteria: contraindications according to the package insert include patients who had any of the following: * serious infections * tuberculosis * a history of hypersensitivity to any ingredient of humira® * demyelinating disease or a history of demyelinating disease * congestive cardiac failure

Keywords: humira® behcet's disease adalimumab
a randomized, double-blind, flexible dose, multicenter study to evaluate the effectiveness and safety of galantamine ir in mild to moderate alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this randomized, double-blind, active-controlled, flexible dosage, multicenter study is to evaluate the effectiveness and safety of galantamine tablet (16-24mg/day) for 16 weeks in the treatment of mild to moderate alzheimer's disease (ad) comparing with donepezil.

this is a randomized, double-blind, active-controlled, flexible dosage, multicenter study to evaluate the effectiveness and safety of galantamine tablet in the treatment of mild to moderate ad. the comparator is donepezil tablet. at least 206 patients were to be randomized in the study. the study consisted of 3 phases: a screening phase, a single-blind run-in phase and a double-blind treatment phase. screening phase is less than 2 week for eligible assessment; if the patient was taking any anti-dementia drug at screening, he/she had to stop these drugs and enter into the single-blind run-in phase. the patient who did not take any anti-dementia drug can enter into baseline directly. during the single-blind run-in phase, all eligible patients will take placebo twice daily for 4 weeks. double-blind treatment phase is 16 weeks. at baseline, all patients who are still eligible for inclusion/exclusion criteria will be randomized to either galantamine group or donepezil group at 1:1 ratio, drugs will be taken twice daily by a flexible dose for 16 weeks. dose will be titrated during the first 9-12 weeks. dose will be fixed to 16mg/day or 24mg/day based on tolerability of the patient judged by the investigator. the primary effectiveness endpoint is changes in adas-cog/11 at week 16 from baseline, secondary endpoint is responder rate in term of adas-cog/11. safety evaluation included adverse events, physical examination, ecg, and safety laboratory tests. study drug are taken orally twice a day. the treatment duration was 16 weeks. initial galantamine dose is 8 mg/day, dose was increased to 16mg/day at week 5 and to 24 mg/day at week 9. at week 12, dose was fixed to either 16mg/day or 24mg/day at the discretion of investigators. initial donepezil dose is 5mg/day, dose was then increased to 10mg/day at week 9. at week 12, dose was fixed to either 5mg/day or 10mg/day at the discretion of investigators.

Eligibility criteria:
inclusion criteria: * out-patients diagnosed with mild to moderate probable ad. the diagnosis should have been established in accordance with the classification for probable ad of nincds-adrda * mmse score of 10-24 (inclusive) at screening * patients who lived with or had regular daily visits from a responsible caregiver * .has signed the informed consent form by subject and assent form by care-giver exclusion criteria: * patients with neurodegenerative disorders such as parkinson's disease * patients with some conditions possibly resulting in cognitive impairment, e.g. acute cerebral trauma, infection * has evidence of multi-infarct dementia or clinically active cerebrovascular disease.

Keywords: alzheimer disease galantamine