Kornimate/medical-research-clean huggingface dataset:
study of safety, tolerability, pharmacokinetics, and efficacy of abt-slv187 in subjects with advanced parkinson's disease

Conditions: Advanced Parkinson's Disease

Summary: to explore the safety, tolerability, pharmacokinetics and efficacy of abt-slv187 in advanced parkinson's disease (pd) patients with severe motor complications. the complications of medical devices for the naso-jejunum (nj) infusion system of abt-slv187 will also be investigated.


Eligibility criteria:
inclusion criteria: * idiopathic pd according to the united kingdom parkinson's disease society (ukpds) brain bank criteria * pd stage corresponds to 4 or 5 in the 'off' state according to the modified hoehn \& yahr (h \& y) classification of disease severity * levodopa-responsive subjects demonstrate some identifiable 'on response' established by observation by investigator and demonstrate severe motor fluctuations in spite of individually optimized treatment and where therapy options are indicated exclusion criteria: * diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism * undergone surgery for the treatment of pd * contraindications to levodopa * subjects with any neurological deficit that may interfere with the study assessments

Keywords: levodopa-carbidopa intestinal gel advanced parkinson's disease severe motor fluctuations dyskinesia
feasibility of an app-based nutrition & exercise program in cirrhosis

Conditions: Cirrhosis, Liver; Hepatic Encephalopathy

Summary: the personalized nutrition and exercise app was designed for use by individuals living with chronic conditions. the pilot study examines the acceptance and use of the online, interactive program to support self-management in cirrhosis.

patients living with chronic disease are at-risk for frailty because of their potentially sedentary lifestyle and/or symptoms. supervised exercise programs are useful for improving or maintaining physical capacity as measured by common physical function measures. however, accessibility is limited due to scheduling, transportation, employment, and residential location. unsupervised, self-directed home-based programs have had limited success due to absence of peer support and accountability. an alternative is an app-based program that offers interactive engagement with study staff and accountability. further, follow-along videos and tracking for both nutrition and exercise can be completed at the patient's convenience. a 12-week pilot study with patients living with cirrhosis will assess the acceptability of the programming. the hypothesis is that study participants will find the customization of the app and interaction with the study staff acceptable as measured by completion rates (primary study endpoint). secondary outcomes include change in measures (0-12 weeks) for the 6-minute walk test (6mwt), thigh muscle thickness, and chair sit-to-stands. at the end of the study, participants will also complete a program satisfaction survey (developed in-house). interviews with participants, caregivers, and study staff, conducted via videoconference at 4-6 weeks and end of study, will be descriptively analysed to identify feasibility, acceptability, and perceived utility of the program. analyses will also identify areas for program improvement.

Eligibility criteria:
inclusion criteria: * adult (aged 18 years and older) * diagnosis of cirrhosis (meld\<25) according to biopsy, imaging, elastography, or other * fulfill the guideline-based prophylaxis in place for high risk gastroesophageal varices * able to communicate (e.g., speak, read, and write) in english * provide informed written consent for self exclusion criteria: * hepatocellular carcinoma (hcc) outside of the edmonton liver transplant criteria * previous myocardial infarction * ef \<50% * ischemia on stress testing * oxygen saturation \<95% * non-hcc malignancy * end-stage renal disease. * at the discretion of the healthcare team if a participant can participate in the pilot study
ramelteon for treatment of adult patients with adhd-related insomnia

Conditions: ADHD With Sleep Onset Insomnia

Summary: primary: we hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with adhd when given a trial of ramelteon compared to placebo. secondary:we expect that ramelteon will show statistically significant improvements vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning, including such specific items as focus and social and occupational functioning.

method: 8-week, randomized, double-blind, placebo-controlled crossover trial of ramelteon in adult adhd subjects who suffer from initial insomnia.

Eligibility criteria:
inclusion criteria: * diagnosis of adhd and insomnia- * 19-65 years of age * in good general health * negative pregnancy test exclusion criteria: * current primary psychiatric diagnosis other than adhd * positive urine drug screen for any sedative hypnotic or drugs of abuse * unstable medical condition * hiv positive * seizure disorder * known hypersensitivity to ramelteon
phase 1, first-in-human study of rad140 in postmenopausal women with breast cancer

Conditions: Hormone Receptor Positive Malignant Neoplasm of Breast

Summary: the primary purpose of this study is to evaluate the clinical safety profile, tolerability, and pharmacokinetic (pk) characteristics of rad140 in hormone receptor positive breast cancer.

this is a first in humans study that is designed to evaluate the clinical safety profile, tolerability, and pharmacokinetic (pk) characteristics of rad140 in hormone receptor positive breast cancer.

Eligibility criteria:
key inclusion criteria: * progressive metastatic or locally advanced or metastatic breast cancer. * clinically confirmed as postmenopausal. * eastern cooperative oncology group (ecog) score of 0 to 1 at screening. key exclusion criteria: * her2 positive patients by local laboratory testing. * triple negative breast cancer. * any chemotherapy within the 28 days prior to the first dose of study drug. * any non-chemotherapy anti-cancer drug less than 5 half-lives (30 days for biologics) or less than 14 days for small molecule therapeutics, or if half-life is not known. * tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug. * fulvestrant within 30 days prior to first dose of study drug. * any investigational drug therapy within 5 half-lives of the previous investigational study drug or 30 days, whichever is shorter. * radiation therapy for breast cancer within 2 weeks of dosing and planning to have radiation therapy during participation in this study. * known history of human immunodeficiency virus infection (hiv) or hepatitis c or active hepatitis b infection, unless the patient was diagnosed \>10 years prior to enrollment and no evidence of active liver disease. * currently taking testosterone, methyltestosterone, oxandrolone (oxandrin), oxymetholone, danazol, fluoxymesterone (halotestin), or testosterone-like agents. * untreated or uncontrolled brain metastasis. * diagnosed with or treated for cancer within the previous 2 years, other than breast cancer or non-melanoma carcinoma of the skin. * pregnant and nursing females.
a randomized controlled study of enteral nutrition in septic shock

Conditions: Septic Shock

Summary: there is a paucity of data on the timing and role of enteral nutrition in septic shock. the primary aim of this study is to conduct a phase iii single-center pilot randomized controlled trial comparing early trophic enteral nutrition to 'no enteral nutrition' in mechanically ventilated septic shock patients to determine feasibility.

septic shock represents the body's dysregulated response to an infection, manifesting as persistent hypotension (mean arterial pressure \< 70 mmhg) despite intravenous (iv) fluid resuscitation. severe sepsis and septic shock are major healthcare problems, affecting millions of people around the world each year in critically ill patients without shock, provision of enteral nutrition within 24-48 hours has shown to preserve intestinal epithelium, maintain brush border enzyme activity, maintenance of barrier function to enhance immune function, and preservation of tight cell junctions to reduce permeability. these benefits of enteral nutrition are postulated to prevent downstream complications of nosocomial infections and the multiple organ dysfunction syndrome (mods), though direct data addressing this question are lacking. the primary aim of this study is to conduct a phase iii single-center pilot randomized controlled trial comparing early trophic en to 'no en' in mechanically ventilated septic shock patients to determine feasibility of achieving \>75% consent and compliance rate and \<10% contamination rate.

Eligibility criteria:
inclusion criteria: * adults greater than or equal to 18 years old * clinical diagnosis of septic shock * mechanically ventilation anticipated for at least 48 hours exclusion criteria: * do not resuscitate order * not able to obtain consent * those not able to be randomized within 18 hours * those with small bowel ischemia or obstruction * protracted ileus, intractable vomiting, major gastrointestinal bleeding defined as needing 2 or more units of packed red cells, and any bowel surgery within the previous 30 days prior to intensive care unit admission * those with a contraindication for placement of a feeding tube

Keywords: septic shock mechanical ventilation enteral nutrition trophic feeding
online wellness intervention for primary biliary cholangitis (pbc)

Conditions: Primary Biliary Cirrhosis

Summary: primary biliary cholangitis (pbc) is a chronic autoimmune condition of the liver. persons with pbc have high rates of liver disease-related symptoms and poor health-related quality of life - amongst the lowest of all chronic liver diseases. patients and the canadian pbc society have identified the need for self-care tools to manage symptom burden. building upon a previously developed online wellness program for inflammatory bowel disease (ibd), the researchers have developed a mind-body wellness module specific for patients with pbc. the 12 week module will be delivered online, and each week is made of an introduction video, 15-20 minutes of yoga, 10-15 minutes of meditation, behavior change tips, and nutrition tips. in a pre-post single arm feasibility study, the researchers will assess how acceptable this module is to patients through looking at rates of refusal, completion rates, and patient feedback. at the beginning and the end of the 12-week research study, participants will complete surveys to assess exploratory outcome measures including stress, anxiety, depression, resilience, quality of life, fatigue, and perceived ability to participate in the 12 week module. after the program, the research team will conduct interviews with participants to allow them to share their other feedback about the program. the researchers will also send surveys to the participants one month after the program ends to asses their continued satisfaction with and adherence to the program.


Eligibility criteria:
inclusion criteria: * adults (≥18 years) * identified diagnosis of pbc * hads score \<=10 * english language proficiency to complete questionnaires and read the educational material * access to the internet and a computer or smart device at home. exclusion criteria: * patients with a major medical co-morbidity * inability to provide informed written consent * severe psychiatric disorders (hads scores \>10)

Keywords: mind body therapy stress quality of life wellbeing yoga meditation psychological
the study on the safety and efficacy of the g-iliac iliac bifurcation stent graft system

Conditions: Common Iliac Artery Aneurysm

Summary: the objective of this study is to evaluate the safety and efficacy of the g-iliac iliac bifurcation stent graft system for endovascular repair of common iliac artery aneurysms(ciaa).

the physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. however, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. during the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the ethics committee.

Eligibility criteria:
inclusion criteria: * patients who have undergone implantation of the iliac bifurcation stent graft system; * patients with complete medical records exclusion criteria: * patients with ruptured aortic aneurysm; * patients with infected or mycotic aortic aneurysm; * patients with connective tissue diseases, such as systemic lupus erythematosus, marfan syndrome, ehlers-danlos syndrome, or behcet's disease

Keywords: lifetech iliac bifurcation stent graft system endovascular repair
pk, pd, safety, and efficacy study of gefurulimab in pediatric patients with achr+ generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis; gMG

Summary: the primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with achr+ gmg for the duration of the study.


Eligibility criteria:
inclusion criteria: united states of america (usa) specific inclusion criterion: * participant must be 12 to \< 18 years of age at the time of signing the informed consent/assent. * all participants must be vaccinated against meningococcal infection from serogroups a, b, c, w, and y within 3 years and at least 2 weeks prior to the first dose of study intervention administration. rest of world (row) specific inclusion criteria: * participant must be 6 to \< 18 years of age at the time of signing the informed consent/assent. * all participants must be vaccinated against meningococcal infection from serogroups a, c, w, y (and b where available) within 3 years prior to study intervention on day 1. if vaccination occurs \< 2 weeks prior to day 1, the participants will receive prophylactic antibiotics for at least 2 weeks after initial meningococcal vaccination for serogroups a,c,w,y (and b, where available) global inclusion criteria: * diagnosis of mg with generalized muscle weakness meeting the clinical criteria defined by myasthenia gravis foundation of america (mgfa) class ii, iii or iv * positive serological test for autoantibodies against achr exclusion criteria: * history of thymectomy, or any other thymic surgery within 12 months prior to screening * untreated thymic malignancy, carcinoma, or thymoma * history of neisseria meningitidis infection * pregnancy, breastfeeding, or intention to conceive during the course of the study

Keywords: acetylcholine receptor antibodies achr+ generalized myasthenia gravis gmg alxn1720 anti-acetylcholine receptor antibody-positive acetylcholine receptor achr myasthenia gravis mg complement component 5 c5 vhh antibody pediatric
prognosis value of transient elastography and non-invasive markers of fibrosis in patients with chronic liver disease

Conditions: Liver Fibrosis

Summary: the aim of this prospective study was to compare the 5-year prognostic value of transient elastography (te), fibrotest (ft), apri , fib-4, lok, and child-pugh scores for predicting survival and complications of cirrhosis in patients with chronic liver diseases.

a total of 1616 patients with chronic hepatitis c was included. at 5 years, 79 patients were dead (39 liver-related deaths) and 16 patients had liver transplantation. overall survival was 91.7% and survival without liver-related death 94.4%. survival was significantly decreased in patients diagnosed with severe fibrosis, whatever the non-invasive method used. all these methods were able to predict a shorter survival in this large population. patients had their prognosis decreased as liver stiffness increased. by multivariate analysis, only fibrotest \> 0.74 (or 4.41, 95%ci 1.62-12.01, p=0.004) was associated with overall survival, and liver stiffness \> 9.5 kpa (or 4.71, 95%ci 1.06-21.01, p=0.04) associated with liver-related death.

Eligibility criteria:
inclusion criteria: * chronic hepatitis c * chronic hepatitis b * alcoholic liver disease * non alcoholic steatohepatitis exclusion criteria: * ascitis

Keywords: liver fibrosis survival transient elastography
cognitive behavioral therapy for adolescents with social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: the main aim of the present study is to investigate the effectiveness of a disorder specific group cognitive behavior therapy (g-cbt) program for youth sad, the, cool kids anxiety program - social enhanced (ck-e), developed at macquarie university, sidney, australia. furthermore, the study will examine how well this program fares against generic cbt treatment.

the main aim of the study is to investigate the effectiveness of a disorder specific g-cbt program for youth sad compared to a generic g-cbt program for anxiety disorders. reduction in anxiety symptoms is expected for both treatment conditions although we hypothesize better outcome for the enhanced treatment condition. approximately 96 adolescents aged 12 to 17 years will be included with data points at pre- and post-treatment, and at 3-month and 1-year follow-ups.

Eligibility criteria:
inclusion criteria: * youth between 12 and 17 years of age. * social anxiety disorder as the primary disorder measured using the anxiety disorder interview schedule for dsm-iv, child and parent version (adis-iv c/p). exclusion criteria: * a diagnosed autism spectrum disorder (asd). * untreated attention deficit hyperactivity disorder (adhd). * psychotic symptoms. * current severe self-harm or suicidal ideation. * current eating disorder. * csr\>5 on depression. * received prior ck treatment within the last two years.

Keywords: social anxiety disorder social phobia youth cognitive behavioral therapy adolescents
cemented marathon/corail versus pinnacle/corail

Conditions: Arthritis of the Hip

Summary: a randomised, comparative, prospective, single-blinded trial of two hip prosthesis: 1. marathon cemented all-poly acetabular cup(depuy, warsaw, indiana), corail uncemented femoral stem(depuy, warsaw, indiana), 32mm alumina biolox forte femoral head(depuy, warsaw, indiana) and 2. pinnacle/marathon uncemented cup(depuy, warsaw, indiana), corail uncemented femoral stem(depuy, warsaw, indiana), 32mm alumina biolox forte femoral head(depuy, warsaw, indiana) there will be a further in-group randomisation to a corail femoral stem with or without a collar, creating a number of 4 study-groups in total. the aims of the study are: * to compare polyethylene wear and migration of the moderately cross-linked marathon polyethylene in a cemented version(marathon) and in an uncemented cup(pinnacle/marathon) * to evaluate micromigration and periacetabular bone mineral density of the 2 cups using radiostereometry(rsa) * to evaluate the migration patterns and proximal femoral bone density changes around the corail stems with and without a collar


Eligibility criteria:
inclusion criteria: * age under 70 years with primary or secondary arthritis of the hip, aseptic necrosis of the femoral head, acute hip fracture or sequelae after hip fracture. exclusion criteria: * active malignant disease, rheumatoid arthritis or other generalised auto-immune arthritic disease, * bmi \> 35, * insulin dependent diabetes mellitus, 0 chronic or recurrent infection, * liver disease, * paget's disease, * dementia or lack of compliance for other reasons, * uncompensated cardiac or pulmonary disease(asa class 3 or 4). prosthesis in the contralateral hip does not exclude the patient, but only one hip in each patient can be included in the study.
to compare the response rate of noradrenaline vs. terlipressin in hepatorenal syndrome in patients with acute on chronic liver failure

Conditions: Acute on Chronic Liver Failure

Summary: continous infusion of nor adrenaline + albumin continous infusion of terlipressin + albumin response will assessed at every 48 hour (i) complete response: regression of acute kidney injury stage with reduction of s. cr within 0.3 mg/dl of baseline (ii) partial response: regression of acute kidney injury stage with reduction of s. cr to ≥0.3 mg/dl above baseline (iii) no response: no regression of acute kidney injury treatment will be extended until reversal of hrs (decrease in creatinine below 1.5 mg/dl) or for a maximum of 7 days after rescue treatment will be followed. if intolerant to terlipressin, excluded from study and rescue treatment will be given in form of noradrenaline or octreotide and midodrine.


Eligibility criteria:
inclusion criteria: 1. patients with acute on chronic liver failure presenting with hepatorenal syndrome 2. patients consented for the study protocol by signing the informed consent. exclusion criteria: 1. age less than 18 years 2. decompensated cirrhotics 3. evidence of chronic kidney disease 4. patients undergoing renal replacement therapy (hemo-dialysis/renal transplantation). 5. post liver transplantation patients. 6. history of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease. 7. patients with obstructive uropathy. 8. patient who withdrew or non complaint to the study protocol.
phase iv clinical trial to evaluate the efficacy and safety of jublia® in mild to moderate toenail onychomycosis

Conditions: Mild to Moderate Onychomycosis Due to Dermatophyte

Summary: the antifungal efficacy and safety of jublia® topical solution will be assessed through an administration for 48 weeks to patients diagnosed with a mild or moderate onychomycosis due to dermatophyte.

evaluate anti-fungal activity and safety of efinaconazole in patients with mild to moderate toenail onychomycosis caused by dermatophytes that received a 48-week administration of efinaconazole.

Eligibility criteria:
inclusion criteria: * adult male and female subjects of ages in the range over 19. * the subjects diagnosed with onychomycosis in up to 6 toenails at least 1 great toenail woth no fingernails * the subjects diagnosed with a mild to moderate onychomycosis (20% to 50% of surface of target nail without nail matrix infection or dermatophytoma) * the subjects having target nails less than 3mm in thickness and over 3mm in length * positive indication on koh direct microscopic inspection on target nail * positive dermatophyte or dermatophyte/candida on fungi cultivation inspection on target nail * the subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent. exclusion criteria: * the subjects suffering other diseases that may cause nail abnormalities or are supposed to be affecting the assessment of the efficacy of study agent by the judgment of investigators * the subjects having a case history of hypersensitivity reaction to the component of jublia® topical solution or azole derivatives. * the pregnant, lactating, or fertile woman free from pertinent contraception

Keywords: onychomycosis