Kornimate/medical-research-clean huggingface dataset:
feasibility and optimization of a cognitive intervention for parkinson disease

Conditions: Parkinson Disease

Summary: this study investigates the feasibility of a cognitive strategy training intervention for people with parkinson disease (pd). we plan to recruit 8 non-demented pd participants to complete 6 weekly treatment sessions and pre- and post-testing (8 sessions total, entire study duration per participant = 8 weeks). we will measure participant responsiveness and the overall efficiency of the intervention process.

cognitive impairment is common in parkinson disease (pd) and is a significant source of disability and reduced quality of life. existing rehabilitative interventions, which focus on cognitive process training, have not been successful in mitigating its negative functional consequences. we have developed a client-centered cognitive strategy training intervention to enable people with pd to work around their cognitive deficits and maintain their functional performance. this study is an exploratory case series to assess aspects of its feasibility. specifically, we will assess participant responsiveness to the intervention (acceptance, engagement, adherence), and we will track logistical information (e.g., scheduling). we will also administer an exploratory outcome measure of treatment effect to gain preliminary evidence on the effect of the intervention on self-identified cognitive performance problems. this information will guide modifications and enhancements in preparation for future clinical trials.

Eligibility criteria:
inclusion criteria: * males and females over age 50 who meet criteria for idiopathic typical pd, are hoehn \& yahr stage i-iii (mild to moderate disease; hoehn \& yahr, 1967) and are treated with levodopa/carbidopa. for this early phase of development we will limit enrollment to people who can identify at least one daily cognitive performance problem and are willing to learn strategies to address it. exclusion criteria: * possible dementia, medication change over the study period, other neurological disorders, brain surgery (e.g., stn dbs), history of psychotic disorder or significant current psychiatric disorder (i.e., moderate to severe anxiety, apathy or depression), or any condition that would interfere with participation (e.g., non-english speaking). participants taking benzos will be excluded.
a research study in chinese people with allergy to house dust mites, using an environmental exposure chamber

Conditions: Allergic Rhinoconjunctivitis

Summary: this trial evaluates the efficacy and safety of hdm slit-tablet in treatment of hdm ar. the efficacy is evaluated using an environmental exposure chamber (eec). subjects will be randomised to receive treatment with hdm slit-tablet and placebo 1:1.

this trial is a 24 weeks, randomised, parallel-group, double-blind, placebo-controlled phase iii trial. approximately 202 subjects will be randomised (1:1) to receive treatment with hdm slit-tablet or placebo. the trial will be conducted in china, with subjects recruited and treated in china. two eec assessments (baseline and end of treatment) will take place at a validated eec facility in austria. the primary objective is to demonstrate the efficacy of the hdm slit-tablet (12 sq-hdm) once daily compared to placebo in the treatment of hdm ar nasal symptom determined during the eec session at week 24.

Eligibility criteria:
inclusion criteria * male or female chinese subjects aged ≥18 years * a clinical history of hdm ar/c with or without asthma * positive spt and ige to der p or der f at screening * a tnss of at least 6 of 12 within the first 2 hours of the screening eec session prior to randomisation exclusion criteria * sensitised and regularly exposed perennial or seasonal allergens * asthma requiring treatment with high-dose ics * reduced lung function * has a nasal condition that could confound the efficacy or safety assessment * a relevant history of systemic allergic reaction

Keywords: house dust mite allergic rhinitis allergic conjunctivitis china environmental exposure chamber
benefit and tolerability of iqp-as-105 in reducing susceptibility to upper respiratory tract infections

Conditions: Common Cold; Upper Respiratory Tract Infections

Summary: iqp-as-105, is a food supplement derived from garlic (allium sativum). the objective of this study is to evaluate the possibilities of clinical use of iqp-as-105 as a preventive medicine, based on its ability to enhance the immune system responses


Eligibility criteria:
inclusion criteria: * age 18-70 years * increased risk for infections - at least 4 cold episodes within 12 months * commitment to adhere to their accustomed diet and physical activity * women of child-bearing potential have to agree to use appropriate birth control methods * written consent of the subject to participate is a prerequisite for study participation exclusion criteria: * acute / chronic upper airways disease * chronic cough of any origin * acute / chronic lower airways disease * any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis) * history of nasal reconstructive surgery * presence of nasal ulcers or nasal polyps * severe nasal septum deviation or other condition that could cause nasal obstruction * congenital or acquired immunodeficiency disease (e.g. hiv infection) * severe organ or systemic diseases * body temperature above 37.5°c * suspected swine flu or influenza * vaccination against influenza or swine flu within 3 months prior to study start * stomach/gastrointestinal diseases * sleep disorder * psychiatric disorders * known sensitivity to the ingredients of the investigational product * intake of products that may influence the study outcome within the last 14 days prior to study start and during the study * analgesics , antibiotics or decongestant nose drops/spray, unless they are used as rescue medications * pregnancy or nursing * alcohol / drug abuse * simultaneous participation in another clinical trial or participation in a clinical trial within the last 30 days * insufficient compliance
pharmacokinetics following single-dose of valsartan in japanese pediatric patients

Conditions: Hypertension; Chronic Kidney Disease; Nephrotic Syndrome

Summary: this study will assess the pharmacokinetics and safety following single dose of valsartan in japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.


Eligibility criteria:
inclusion criteria: * japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome exclusion criteria: * gfr \< 30 ml/min/1.73 m2 * inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion. * inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes). other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, chronic kidney disease nephrotic syndrome pharmacokinetics
osteoporosis awareness in rheumatoid arthritis patients

Conditions: Osteoporosis; Rheumatoid Arthritis

Summary: osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. rheumatoid arthritis patients are at increased risk for developing osteoporosis. it is crucial to identify whether rheumatoid arthritis patients know and know about this disease. this study investigates awareness and knowledge of osteoporosis in rheumatoid arthritis patients.

osteoporosis is a common disease of bone loss. the reduced bone strength predisposes an increased risk for fractures in older individuals. it can affect people from different ethnicity. many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin d, immobility, and chronic inflammation. patients with rheumatoid arthritis are at high risk of developing osteoporosis due to chronic inflammation and the medications they use. patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. this study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with rheumatoid arthritis.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of rheumatoid arthritis * must be between the ages of 18 and 90 * must give consent to participate in the study exclusion criteria: • not giving consent
evaluation of a powered stapler system on surgical interventions required during laparoscopic sleeve gastrectomy

Conditions: Obesity

Summary: this study will provide clinical data in an observational setting. individuals undergoing lsg, and who meet study entry criteria, may be enrolled. lsg procedures will be performed according to institutional standard-of-care (soc) using the study stapler. all study subjects will be followed for approximately 4 weeks for safety and outcomes.


Eligibility criteria:
inclusion criteria: * scheduled for laparoscopic sleeve gastrectomy; * subject meets nih weight loss surgical criteria; * bmi ≤ 60 kg/m2; * willing to give consent and comply with study-related evaluations; and * at least 18 years of age exclusion criteria: * previous bariatric procedures, including gastric banding; * prior gastric surgery; * scheduled concurrent surgical procedure (hiatal hernia repair, cholecystectomy allowed); * pregnancy; * known or suspected uncontrolled bleeding disorders; * history of chronic steroid use; * patients who have undergone significant upper gi surgery leading to adhesion; formation, as determined by the principal investigator; * physical or psychological condition which would impair study participation; * the patient is judged unsuitable for study participation by the investigator for any other reason; or * unable or unwilling to attend follow-up visits and examinations.
substituting mushrooms for meat to control body weight

Conditions: Obesity

Summary: this is a one-year clinical trial to assess weight-loss, weight-maintenance, and biochemical parameters following a weight-control diet using either standard food guide pyramid alone, or standard food guide pyramid with substitution of mushrooms for meat.

this intervention study has a primary aim to assess omnivorous adult males and females' ability to control their weight over a period of 1 year. the control group will be required to use 90% lean ground beef a few times per week for one year while maintaining their personalized diet plans. the experimental group will have to follow their personalized diets as well, but will be required to substitute mushrooms for meat at least three times per week. biochemical measures will also be assessed in response to the diet and weight loss.

Eligibility criteria:
inclusion criteria: * male, female, \>=18 years old * omnivorous * bmi 25-40 * seeking weight-loss exclusion criteria: * \<18 years old * vegetarians * dislike mushroom * chronic disease * hiv+ * rheumatoid arthritis * pregnant or nursing child * must not self-report allergies to mushrooms

Keywords: obesity weight weight-loss mushroom oxidative stress immune function inflammation
tenofovir abacavir platelet activation study

Conditions: HIV

Summary: some but not all observational studies have found that current exposure to abacavir is associated with increased risk of cardiovascular events such as myocardial infarction, stroke and cardiovascular death. this study aim to investigate possible adverse effect of abacavir on platelet reactivity, coagulation and endothelial activation in hiv-1 infected patients. the study is an open-labeled cross-over trial, where patients receiving antiretroviral therapy containing abacavir switch treatment to a regimen containing tenofovir and vice versa for a period of 90 days.


Eligibility criteria:
inclusion criteria: * hiv-1 infected * can understand and sign written informed consent * received one of the above mentioned antiretroviral regimens continuously ≥ 6 months * hiv rna \< 400 copies/ml for ≥ 6 months exclusion criteria: * receiving anticoagulant therapy, adenosine diphosphate (adp) receptor inhibitors, aspirin or nonsteroidal antiinflammatory drugs (nsaids) * previous ischemic heart disease, peripheral atherosclerotic disease or stroke * coagulation disorder (e.g. hemophilia, factor v leiden mutation) * platelet count \< 150 x 109/l during the past 6 months from inclusion * estimated glomerular filtration rate (egfr) \<70 during the past 6 months from inclusion * humane leukocyte antigen (hla)-b\*57:01 positive genotype * hepatitis b or c positive during the past year from inclusion * hypersensitivity to the active substances or to any of the excipients

Keywords: hiv-1 abacavir platelet activation thromboelastography coagulation
digital therapeutic workplace technology as a employee management tool and employee's mental health care

Conditions: Depression; Mental Health Issue

Summary: the purpose of the study is to determine whether a digital healthcare app for employee's mental health can effectively improve the mental health of hisbeans's employees and the managerial performance of hisbeans, which is represented as a 'social enterprise'.

hisbeans is a social enterprise where employees are consist of individual with mental disabilities. 'hisbeans' employees(n = 150 subjects) will be randomly assigned to group 1 (maro intervention), or group 2 (control app intervention) by cluster randomization depending on the branch of the company. * maro intervention group: maro (mental health digital application) use * control group: sham app use the intervention period will be 8weeks.

Eligibility criteria:
inclusion criteria: 1. hisbeans store employees 2. age: 18 years old or older 3. possessing a smartphone with internet connection 4. subjects agree to participate in the study exclusion criteria: 1. those who have symptoms of psychotic disorder are acutely active or advanced, making clinical intervention difficult 2. those who has been started or changed their antidepressant medication within the last 1 month or cannot be maintained stably during the intervention period 3. those who are non-literate 4. those who have used the maro app previously 5. those who couldn't use maro app in their own smartphone 6. those who participate in another intervention study 7. those who have a serious medical condition that prevents them from participating in the intervention and efficacy evaluation 8. those who is unable to participate fully and cooperatively by the judgment of the researcher
efficacy of n-acetylcysteine with or without steroids in drug induced liver injury

Conditions: Drug Induced Liver Injury

Summary: intervention - subjects will be randomized to 2 groups group a - subjects will receive prednisolone for 20 days with nac (n-acetylcysteine) group b - will receive nac (n-acetylcysteine) only nac (n-acetylcysteine) dosing loading dose: 150 mg/kg iv; mix in 200 ml of 5% dextrose in water (d5w) and infuse over 1 hour dose 2: 50 mg/kg iv in 500 ml d5w over 4 h dose 3: 100 mg/kg iv in 1000 ml d5w over 16 h * monitoring and assessment-liver biopsy at baseline and at 3 months, liver function test at regular intervals. * stopping rule-development of sepsis, worsening of liver functions.


Eligibility criteria:
inclusion criteria: * all patients with severe dili (drug induced liver injury) * age more than or equal to 18 years exclusion criteria: * patients with hav (hepatitis a virus), hbv (hepatitis b virus), hcv (hepatitis c virus), hev (hepatitis e virus) positive * patients with sepsis * ama positive * low ceruloplasmin * transferrin saturation \>45% * patients with cirrhosis * patients with h/o jaundice prior to the intake of drug
a study of ion251 administered to patients with relapsed/refractory multiple myeloma

Conditions: Relapsed Multiple Myeloma; Refractory Multiple Myeloma

Summary: the purpose of this study is to determine the maximum-tolerated dose (mtd) and recommended phase 2 dose (rp2d) of ion251 in patients with relapsed/refractory multiple myeloma.

this is a two-part, multi-center first in human study of ion251 in up to 80 participants. part 1 will use a 3+3 dose-escalation scheme in sequential cohorts to determine the mtd and rp2d during repeated 28-day treatment cycles. mtd will be determined by the number of participants with aes meeting the dose-limiting toxicity (dlt) criteria during cycle 1. the mtd determined in part 1 will be used with other variables to inform a rp2d for participants proceeding to part 2 for further assessments in the safety, tolerability and anti-myeloma activity.

Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years at the time of informed consent 2. eastern cooperative oncology group (ecog) performance status of 0 or 1 3. measurable multiple myeloma (mm) 4. in need of systemic treatment for mm and either is refractory to or has failed treatment with, is intolerant to or has refused, or is not otherwise a candidate in the opinion of the investigator, for any of the currently available established therapies known to provide clinical benefit in relapsed/refractory mm. refractory to treatment is defined as documented mm disease progression while on or within 60 days from the last dose (ld) of treatment exclusion criteria: 1. screen laboratory results as follows, or any other clinically significant abnormalities in screen laboratory values that would render a participant unsuitable for inclusion * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2 × upper limit of normal (uln) * total bilirubin \> 1.3 × uln * absolute neutrophil count ≤ 1.0 1000/cubic millimeter (k/mm\^3) * platelet count \< 50 k/mm\^3 * hemoglobin \< 8.0 g/dl * estimated glomerular filtration rate (egfr) \< 50 milliliters per minute (ml/min)/1.73 square meter (m\^2) * urine albumin creatinine ratio \> 100 mg/g 2. history of or current plasma cell leukemia, poems (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone or extramedullary plasmacytoma as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm 3. uncontrolled hypertension (systolic pressure ≥ 160 mm of mercury (mm hg) and/or diastolic pressure ≥ 100 mm hg) 4. presence of a bleeding disorder or an underlying disease state associated with active bleeding.

Keywords: multiple myeloma relapsed multiple myeloma refractory multiple myeloma
a comparative study of brain structure and amyloid load in mci patients

Conditions: Mild Cognitive Impairment

Summary: older people with dm are at greater risk of cognitive decline than their counterparts with dm. cognitive impairment in older people with dm may be associated with non-ad related brain atrophy and white matter disease. the investigators therefore propose to compare dm and non-dm older people with amnesic mci in brian volumes, white matter disease and amyloid load. 30 older people with amci, 30 older people with amci and dm, age 65-85 will be recruited. they all will have amyloid pet scan and mri brain scan.


Eligibility criteria:
inclusion criteria: * mci patients exclusion criteria: * patients with depression
efficacy, safety, and tolerability of acz885 in patients with muckle-wells syndrome

Conditions: Muckle Wells Syndrome

Summary: this study is designed to provide efficacy and safety data for acz885 (a fully human anti-interleukin-1beta (anti-il-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in patients with muckle-wells syndrome. part i is an 8-week open-label, active treatment period to identify acz885 responders. part ii is a double-blind, placebo-controlled period to assess primarily the efficacy of acz885 compared to placebo. part iii is an open-label, active treatment period where patients will receive acz885 every 8 weeks after withdrawal or completion of part ii.


Eligibility criteria:
inclusion criteria: * molecular diagnosis of nalp3 mutations and clinical picture resembling muckle-wells syndrome. * muckle-wells syndrome patients who participated in the cacz885a2102 study, will have the option to participate in this study upon disease flare * muckle-wells syndrome patients requiring medical intervention either untreated or treated (i.e. under acz885, anakinra, or any other investigational il-1 blocking therapy). exclusion criteria: * history of being immunocompromised, including a positive hiv at screening test result. * no live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose. * history of significant medical conditions, which in the investigator's opinion would exclude the patient from participating in this trial. * history of recurrent and/or evidence of active bacterial, fungal, or viral infections. * positive tuberculin skin test at 48 to 72 hours after administration at the screening visit or within 2 months prior to the screening visit, according to national guidelines. other protocol-defined inclusion/exclusion criteria may apply

Keywords: muckle-wells syndrome children systemic autoinflammatory disease cias-1 gene nalp-3 acz885 human monoclonal anti-human interleukin-1beta (il-1beta) antibody autosomal dominant familial autoinflammatory syndrome
a multi-center study to assess the efficacy and safety of lx211 in active non-infectious anterior uveitis

Conditions: Uveitis, Anterior; Panuveitis

Summary: the objective of this study is to evaluate the safety and efficacy of lx211 as therapy in subjects with active non-infectious anterior uveitis


Eligibility criteria:
inclusion criteria: * documented history of non-infectious anterior, anterior and intermediate- or panuveitis * currently uncontrolled uveitis for a minimum of 2 weeks despite use of oral and/or topical corticosteroid,or subjects who are intolerant of local corticosteroid therapy due to the development of an ocular hypertensive response or subjects for whom oral corticosteroid is contraindicated. * grade of 2+ or higher for anterior chamber cells at time of enrollment * considered by the investigator to require corticosteroid-sparing therapy. * subjects not planning to undergo elective ocular surgery during the study exclusion criteria: * uveitis of infectious etiology * presence of an ocular toxoplasmosis scar * an immune suppression regimen that includes an alkylating agent within the previous 90 days

Keywords: uveitis calcineurin inflammation