Kornimate/medical-research-clean huggingface dataset:
food effect study of ddo-3055 tablets in healthy subjects

Conditions: Anemia in Chronic Kidney Disease

Summary: the study is a randomized , open-label, two-stage crossover food effect study of single doses of ddo-3055 tablets in healthy subjects. 14 healthy subjects were randomly divided into groups a and b, 7 subjects in each group. two stage washout period is 6 days.


Eligibility criteria:
inclusion criteria: * 1. healthy male volunteers, aged 18\~45. * 2. body weight ≥ 50 kg, body mass index (bmi) between 18 to 28. * 3. hemoglobin is in the normal range. * 4. signed informed consent. exclusion criteria: * 1. vital signs, physical examination, laboratory results are abnormal and clinically significant. * 2. currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases. * 3. suspected allergy to the active ingredient or excipient of the experimental drug. * 4. have used erythropoietin within 1 month prior to screening or are currently using erythropoietin. * 5. had donated blood or blood transfusion within 3 months prior to screening. * 6. vein blood collection is difficult or physical condition can not afford blood collection. * 7. hepatitis b virus surface antigen (hbsag), hepatitis c virus antibody (hcvab), syphilis antibody, human immunodeficiency virus antibody (hivab)were positive. * 8. average daily smoking ≥5 cigarettes within 3 months before screening; average daily intake of alcohol within one week is more than 15g (15g alcohol is equivalent to 450ml beer or 150ml wine or 50ml low-alcohol liquor);or 2 days before taking the study drug and during the trial take the tobacco and alcohol and caffeinated foods or drinks, and have special dietary requirements and cannot follow a uniform diet. * 9. 3 months prior to screening involved in any drug or medical device clinical trials, or within 5 half-life of drugs before screening. * 10. any health care products, over-the-counter drugs or prescription drugs that affects the absorption, distribution, metabolism and excretion of the experimental drug was used within 1 month before the administration. * 11. with a history of drug abuse or screening visit/baseline visit urine drug abuse screening positive. * 12. subjects who are unwilling to take contraceptives or who are likely to donate sperm during the trial and within 30 days after administration; or who do not agree to physical contraception during the trial. * 13. other conditions in which the study physician considered the subject not suitable for the trial.
cardiac radiotherapy for ventricular tachycardia

Conditions: Ventricular Tachycardia

Summary: objective: to explore in our center the feasibility and safety of a sbrt treatment method for vt. study population: patients with ventricular tachycardia that are refractory to dose-escalated antiarrhythmic drugs and where catheter ablation has either already been performed or is deemed to be unsuccessful or associated with high risks. intervention: patients will be treated with a stereotactic body radiotherapy technique as a single fraction treatment up to a dose of 25 gy delivered to the vt substrate defined by electrophysiological mapping. main study endpoints: the primary aim is to explore the feasibility and safety of a sbrt treatment method for refractory vt. secondary endpoints include an assessment of the efficacy of the treatment, quality of life, late toxicity and overall survival. patients will have to fill in a quality-of-life questionnaire before and after the radiotherapy treatment. the risk associated with this trial is an increase in toxicity.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years * presence of a structural heart disease and an implantable cardioverter defibrillator (icd) * documented sustained monomorphic vt that requires icd intervention (e.g., shock or anti-tachycardia stimulation) * the vt is inducible by icd via non-invasive programmed stimulation (nips) or during electrophysiology measurement * patient must have failed or become intolerant to at least one antiarrhythmic medication * patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure, or have vt thought to arise from a protected location * ability to give a written informed consent and willingness to return for follow-up exclusion criteria: * pregnancy or breastfeeding * lack of evidence of a myocardial scar triggering the vt * polymorphic vt or ventricular fibrillation (vf) as a clinical heart rhythm * advanced symptomatic heart failure defined as nyha class iv heart failure * previous radiotherapy with cardiac involvement * life expectancy \< 6 months, in the absence of vt, as best based on clinical judgment by the treating and enrolling physicians * any condition that is deemed a contraindication in the judgment of the investigators
correlation of genetic polymorphism and livedo vasculitis

Conditions: Livedo Vasculitis; Livedoid Vasculitis; Livedoid Vasculopathy; Genetic Pleomorphism; Leiden Mutation

Summary: livedo vasculitis is disease with recurrent courses of painful foot or ankle ulcerations, followed by healed white scars. the actual mechanism of its pathophysiology is not yet clear. it has been reported to be associated with some gene mutations, for example, factor v leiden gene. this study is aimed to find the possible relation of these gene mutations in taiwanese patients.

livedo vasculitis is a chronic, recurrent painful ulcerations on the ankles and feet. this chronic disease is characterized by healed white, atrophic scars named atrophie blanche. the histopathological exam on the lesion site reveals fibrin deposition within the vessel walls. it has been reported to be related to factor v leiden mutation (heterozygous) (22.2%), prothrombin g20210a gene mutation (8.3%), pai promotor 4g/4g genotype and methylenetetrahydrofolate reductase (mthfr) c677t mutation in about total 30% livedo vasculitis patients. this study is trying to find the correlation between taiwanese patients and these four genes.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of livedo vasculitis exclusion criteria: * no special exclusion criteria

Keywords: livedo vasculitis genetic pleomorphism
cognition and motor learning post-stroke

Conditions: Stroke; CVA (Cerebrovascular Accident)

Summary: this project seeks to determine how post-stroke cognitive impairment moderates motor learning during walking in older adults with chronic stroke and identify brain structural markers that mediate this relationship. the chosen experimental design integrates biomechanical analyses, neuropsychological assessments, and brain imaging techniques to determine the impact of post-stroke cognitive impairment severity on two forms of motor learning (explicit and implicit) and examine the role of the dorsolateral prefrontal cortex in the relationship between cognition and explicit motor learning. ultimately, this work may lead to the development of a more comprehensive, effective treatment approach to improve walking dysfunction in older adults post-stroke.


Eligibility criteria:
inclusion criteria: * unilateral stroke * stroke occurred more than 6 months prior * paresis confined to one side * independently ambulatory (including the use of assistive devices) * able to walk for 5 minutes without stopping * answers no to all general health questions on the par-q+ * willingness to complete study procedures exclusion criteria: * brainstem or cerebellar stroke * aphasia (expressive, receptive, or global) * any major musculoskeletal or non-stroke neurological condition that interferes with the assessment of sensorimotor or cognitive function * metal in the head (except in the mouth), implanted cranial or thoracic devices that violate mri safety regulations * uncontrolled hypertension (\>160/110mmhg) * concurrent physical therapy * claustrophobia * significant cognitive deficit or dementia (\<20 on moca) * inability to give informed consent

Keywords: stroke walking rehabilitation cognition
a study of tepezza® treatment in participants with thyroid eye disease

Conditions: Thyroid Eye Disease

Summary: the main goal of this study is to learn how teprotumumab will be processed in the body (pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease.

this is a phase 1b, open-label, multicenter trial to assess the pk, safety, and tolerability of a single sc dose of lyophilized teprotumumab and high concentration formulation teprotumumab in participants with thyroid eye disease. approximately 6 participants (in cohort 1) and approximately 10 participants (in cohort 2) who meet the trial eligibility criteria will be enrolled in a 1:1 ratio. study acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: 1. thyroid eye disease (not sight-threatening but has an appreciable impact on daily life), usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, proptosis, and/or inconstant or constant diplopia. 2. proptosis ≥ 3 mm increase from the participant's baseline (prior to diagnosis of ted), as estimated by treating physician and/or proptosis ≥ 3 mm above normal for race and gender. 3. participant must be euthyroid with baseline disease under control or have mild hypo- or hyperthyroidism at screening. every effort should be made to correct the mild hypo or hyperthyroidism promptly and to maintain the euthyroid state for the full duration of the trial. 4. does not require immediate surgical ophthalmological intervention. 5. participants with diabetes must have hba1c ≤ 8.0% at screening. exclusion criteria: 1. decreased best-corrected visual acuity due to optic neuropathy within the last 6 months. 2. corneal decompensation unresponsive to medical management in the study eye. 3. decrease in proptosis of ≥ 2 mm in the study eye between screening and baseline. 4. alanine aminotransferase or aspartate aminotransferase \> 3x the upper limit of normal or estimated glomerular filtration rate ≤ 30 ml/min/1.73 m2 at screening. 5. use of any steroid (iv, oral, steroid eye drops) for the treatment of ted or other conditions within 3 weeks prior to screening. steroids cannot be initiated during the trial. exceptions include topical and inhaled steroids and steroids used to treat infusion reactions. 6. any treatment with rituximab, tocilizumab, or any other non-steroid immunosuppressive agent within 90 days prior to the first injection of investigational product on day 1. 7. any previous treatment with hzn-001 or tepezza (teprotumumab-trbw), including previous enrollment in this trial or participation in a prior tepezza trial. 8. treatment with any mab within 3 months prior to screening.

Keywords: thyroid eye disease tepezza teprotumumab
f 18 t807 tau pet imaging of frontotemporal dementia (ftd)

Conditions: Alzheimer Disease

Summary: the purpose of this research study is to evaluate tau distribution in the brain of subjects with: ftd caused by different genetic mutations, any mutation carriers (with or without symptoms), any non-mutation carrier, any sporadic ftd, normal controls.


Eligibility criteria:
inclusion criteria: 1. male or female participants, at least 18 years of age. 2. clinically diagnosed with frontotemporal dementia (ftd), or a carrier of a mutation known to cause ftd (with or without symptoms); or a normal control. 3. participant is able and willing to undergo testing (mri or ct, pet, radioactive tracer injection, lp; for those unable to undergo an mri, ct will be used to generate regions-of-interest). 4. pre-menopausal women will have a negative a urine pregnancy test within 24 hours of t807 drug administration. exclusion criteria: 1. has any condition that, in the investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures). 2. is deemed likely unable to perform the imaging procedures for any reason. 3. has a history of torsades de pointes or is taking medications known to prolong qt interval. to determine who will be excluded from this study based on this criterion, we will review participant's medical history and current medications at time of screening. participants will be excluded from the study if any of the following restricted medications are being taken: * disopyramide * dofetilide * ibutilide * procainamide * quinidine * sotalol * bepridil 4. has hypersensitivity to f 18 t807 or any of its excipients. 5. contraindications to pet, pet-ct or mr (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate. 6. severe claustrophobia. 7. currently pregnant or breast-feeding. 8. for those electing to undergo the optional lumbar puncture: on anticoagulant of any form prior to lumbar puncture.

Keywords: dementia brain diseases central nervous system diseases mild cognitive impairment tauopathies neurodegenerative disease
monitoring blood flow and breathing using a new device (rfii) compared to the gold standard device in post operative cardiac patients

Conditions: Noninvasive Cardiac Monitoring

Summary: the purpose of this study will be to compare standard of care invasive methods to an fda approved non-invasive device and a novel wireless non-invasive device, both manufactured by non-invasive medical technologies inc., with the goal of correlating the data generated by the novel device to the measurements taken by the standard of care invasive monitors.


Eligibility criteria:
inclusion criteria: * 18 years and older * weight - 36-136 kilograms * height - 1.52 meters - 1.92 meters (5'- 6'4") * scheduled for open heart surgery during the study period exclusion criteria: * ecg lead adhesive allergy or sensitivity * pregnant patients * prisoners * cognitively impaired * patients requiring mechanical cardiac support, or requirement for hemodialysis * patients not requiring pulmonary artery catheters for medical management. * patients with significant valvular disease will be enrolled if there is no significant post-repair valvular dysfunction as determined by intraoperative transesophageal echocardiography
a multi center study comparing the efficacy of cad eye and the standard of care (white light )

Conditions: Colorectal Cancer

Summary: this study is to assess the sensitivity and added benefits of cadeye compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.

failure in polyp recognition is a major determinant for the high rate of missed colorectal neoplasms. in response, technological advances have paved the way for computer-aided polyp detection (cad-e) systems. artificial intelligence systems allow of real-time computer- aided detection of polyps with high-accuracy. cadeye is a cad-e system (fujifilm) that enables real-time video processing at the same rate as the standard procedure. the data generated from this study will provide an estimate of the adr throughout the middle east as well as assess the accuracy of cadeye in detecting adenomas in comparison to standard of care.

Eligibility criteria:
inclusion criteria: * 40-80 years old subjects * subjects undergoing colonoscopy for the following: o primary crc screening * post-polypectomy surveillance * work up following fit positivity * symptoms/signs suspicions of crc * subjects must be willing to give written informed consent for the trial exclusion criteria: * unable to consent * contraindicated to undergo endoscopy * hospitalized patient * patients with the following conditions: * history of colon resection * history of crc * antithrombotic therapy precluding colon resection o inflammatory bowel disease (ibd) * familial adenomatous polyposis (fap) * pregnant or lactating * poor bowel preparation: bbps 0 or 1 in a segment

Keywords: colorectal cancer screening
electrohydraulic versus laser lithotripsy for treatment of difficult to remove biliary stones

Conditions: Gall Stones

Summary: bile duct stones that can't be removed by conventional means can often be removed after fragmentation by shock waves (lithotripsy). the shock waves that are used for fragmentation of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser (laser lithotripsy). although both techniques have been used for many years, there are no studies comparing the efficacy of the two. the purpose of this study is to find out which technique is more effective.

procedures will be considered standard of care; patients or insurance companies will be billed as it is standard of care.

Eligibility criteria:
inclusion criteria: * 1 or more gall stones in bile duct which cannot be removed using conventional methods (must be fragmented) * adults able to provide informed consent exclusion criteria: * pregnancy or lactation

Keywords: biliary lithotripsy gall stones bile duct biliary stones
phase 2 efficacy, safety, and tolerability study of natalizumab in focal epilepsy

Conditions: Epilepsy, Focal Seizures, Partial Seizures

Summary: the primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (iv) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy. the secondary efficacy objective is to assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on additional measures of seizure frequency.


Eligibility criteria:
key inclusion criteria: * must have focal epilepsy diagnosed on clinical grounds and as applicable supported by electroencephalogram findings \[scheffer 2017\] and brain imaging. participants with multifocal epilepsy may be included if all other entry criteria are met. * must have a drug-resistant epilepsy defined as failure of adequate trials of 2 (or more) tolerated and appropriately chosen and used aeds (whether as monotherapies or in combination) \[kwan 2010\]. * experiences 6 or more seizures during the 6-week prospective baseline period and is not seizure free for more than 21 consecutive days during the prospective baseline period key exclusion criteria: * focal aware seizures without motor signs are the only seizure type. * diagnosis of generalized, combined generalized and focal, or unknown epilepsy * known progressive structural cns lesion. * history of seizures occurring in predominantly clustered patterns, as determined by the investigator, over the 12 months prior to the screening visit (week -6) or during the 6-week prospective baseline period, where individual seizures cannot be counted. * history of status epilepticus within the previous 6 months. * known history or presence of non-epileptic seizures. note; other protocol defined inclusion/exclusion criteria may apply

Keywords: drug resistant focal epilepsy, natalizumab, seizure
scandinavian multicenter study to advance risk stratification in heart disease- ventricular arrhythmias

Conditions: Ventricular Arrhythmias; Implantable Defibrillator User; Biological Markers; Heart Disease

Summary: the purpose of this study is to identify markers of increased risk for incident ventricular arrhythmias and cardiovascular events in patients already being treated with an implantable cardioverter-defibrillator (icd) by exploring patient history and clinical findings, biological markers, ecg markers, and echocardiographic markers.

this is a multicenter prospective cohort study to assess the prognostic value of potential biomarkers for incident ventricular arrhythmias and cardiovascular events in patients with implantable cardioverter-defibrillator (icd). in addition to information from the baseline visit and future study visits, the investigators will also register information from the patients medical records concerning comorbidities and previous medical events. the data will be summarized with respect to demographic and baseline characteristics and risk markers/ measurements. the final diagnosis of incident cardiovascular events will be established by an adjudication committee with two senior physicians reviewing all information available on the patients, including information on the clinical outcome of the patient. the investigators will use multivariate statistical models to assess the individual performance of biomarkers/other tests.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old * current treatment with an icd * signed written informed consent before study commencement exclusion criteria: * participation in other interventional clinical trial or previously included in the current study * patients not able to provide written informed consent * known or suspected, non-curable cancer, * neurological condition with short life expectancy; e.g. amyotropic lateral sclerosis (als) * patients unwilling or unable to comply with the protocol * history of non-compliance to medical management and patients who are considered potentially unreliable by the investigator * history or evidence of alcohol or drug abuse with the last 12 months that may influence the participation of the patient in the study, as assessed by the investigator during the screening phase * any surgical or medical condition, which in the option of the investigator, will impair the ability of the patient to participate in the study

Keywords: ventricular arrhythmias icd biological markers
somatosensory profiles in individuals with persistent musculoskeletal pain and inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Chronic Pain; Central Sensitization

Summary: this study evaluates nervous system hypersensitivity in individuals with inflammatory bowel disease (ibd) and experiences of ongoing musculoskeletal (msk) pain. previous results and current literature suggest that msk pain in ibd may be influenced by hypersensitivity of the central nervous system, termed central sensitization. however, specific mechanisms contributing to pain experiences are unknown. therefore, primary aims are to explore aspects of central sensitization through sensory testing in this population, and to investigate association of psychological and ibd features to sensory profiles. this study hypothesizes that ibd patients with msk pain will demonstrate altered sensory function, and ibd/psychosocial features will be associated with altered sensory functioning and worse pain experiences.


Eligibility criteria:
inclusion criteria: * adults (18 years of age or older) * clinical diagnosis of ibd or healthy control exclusion criteria: participants with ibd (with and without msk pain) will be excluded if they report any of the following: * pregnancy * current history of drug or alcohol abuse * any condition resulting in altered sensation such as: nerve injuries, neurological conditions (e.g. stroke, multiple sclerosis, and parkinson's disease) * surgery within the last 3 months

Keywords: chronic musculoskeletal pain central hypersensitivity