Kornimate/medical-research-clean huggingface dataset:
bio|concept.corsky, first in human study for the corsky icd family

Conditions: Tachycardia; Heart Failure

Summary: the goal of this exploratory study is to test the preliminary safety and product performance of the new corsky icd family in subjects that require an icd or cardiac resynchronization therapy with defibrillation (crt-d). the study will be conducted at sites in australia and new zealand. it is planned to include 50 subjects in the study. participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. at the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. programming of the icds will be done according to the participant´s therapeutical needs.


Eligibility criteria:
inclusion criteria: * standard indication for icd or crt-d therapy according to clinical guidelines * planned for de novo implantation of an icd/crt-d, or upgrade/exchange from existing icd/crt-d or pacemaker implant * ability to understand the nature of the study * willingness to provide written informed consent * ability and willingness to perform all on-site follow-up visits at the study site ability and willingness to use the cardiomessenger and acceptance of the biotronik home monitoring concept exclusion criteria: * for vr-t dx and crt-dx: permanent atrial tachyarrhythmia * for vr-t dx and crt-dx: patients requiring atrial pacing * planned for his-bundle-pacing * planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months * pregnant or breast feeding * age less than 18 years * participation in another interventional clinical investigation according to the definition given below 2,3 * life-expectancy less than 12 months
safety and efficacy of wendan decoction in acute moderated to severe brain injury

Conditions: Acute Brain Injury

Summary: efficacy and safety of traditional chinese medicine (wendan decoction) combined with conventional neurologic intensive care in patients with acute moderated to severe brain injury in early stage - a randomized controlled study.

this study adopted a prospective, randomized controlled design. all eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of taichung tzu chi general hospital (rec103-26). patients were recruited from the neurosurgery department of taichung tzu chi general hospital between june 2014 and july 2015. a total of 60 patients were enrolled in this study and randomized into intervention group and control group. all patients of both groups were enrolled within 14 days after episode and a follow-up interview until 6 months from the onset. the intervention group mean regular neuro-intensive care combined tcm and the intervention group mean only neuro-intensive care. but there are 7 patients in intervention group and 12 patients in control group quit out this study

Eligibility criteria:
inclusion criteria: * traumatic brain injury or spontaneously intracerebral hemorrhage within 14 days of onset; * an initial score of 3-12 points of gcs score; * adults between 18 to 80 years old; * and signed informed consent form. exclusion criteria: * after 14 days of onset; * a history of previous tbi or stroke; * intracranial aneurysm or arteriovenous malformation ruptured; * combination other major organ injury (heart, lung, intra-abdomen organ, pelvic fracture, major vessels); * other severe disease such as heart or kidney failure; * previous diagnosed cancer; and pregnant women.

Keywords: traditional chinese medicine combination treatment
changes in the force-velocity relationship of knee muscles after acl reconstruction

Conditions: Anterior Cruciate Ligament Injuries; Muscle Weakness

Summary: anterior cruciate ligament (acl) tear is a frequent and devastating injury in sport, especially in pivoting-contact disciplines. in many cases, athletes will undergo an acl reconstruction (acl-r) for recovering knee stability, preventing further injuries and returning to sport (rts). among the criteria for rts, knee muscle strength is the most used objective criteria and especially the symmetry of knee flexors and/or extensors between the operated and uninjured knee. isokinetic testing of knee muscle strength is considered as a reference for knee muscle testing during the follow up stages after acl-r. this evaluation allows to measure the strength (torque) of knee flexors and extensors at several angular velocities. however, there is no relevant litterature about the force-velocity (fo-v) relationship of knee flexors and extensors after acl-r. the present study aimed to evaluate and test the differences between the fo-v relationship parameters between the operated and uninjured knees at 4 months and 8 months after acl-r, using the 2-points method with isokinetic testing. also, the investigators aimed to test the impact of the type of surgery (patellar tendon autograft vs. hamstring tendon autograft) on the fo-v relationship after acl-r


Eligibility criteria:
inclusion criteria: * patients who have had an acl reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery) * patient included in the sport medicine follow-up protocole with intermediate and final isokinetic muscular assessment at 4 months and8 months after surgery respectively * patients who completed both tests at the 60°/s and 240°/s velocities exclusion criteria: * patient who did not participate in all follow-up consultations and isokinetic muscular assessments * cognitive or sensory impairment making it impossible to understand the information form * neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery
trial of vlts-934 in subjects with intermittent claudication secondary to peripheral arterial disease

Conditions: Peripheral Vascular Disease

Summary: this is a phase ii, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with intermittent claudication (ic) will be randomized to receive a single treatment of vlts-934 (84 ml, or a total of 420 mg poloxamer 188) or placebo (84 ml saline) administered as 21 intramuscular (im) injections of 2 ml each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of vlts-934 as compared with a saline placebo.

this is a phase ii, multicenter, randomized, double-blind, placebo-controlled trial in which subjects with ic will be randomized to receive a single treatment of vlts-934 (84 ml, or a total of 420 mg poloxamer 188) or placebo (84 ml saline) administered as 21 intramuscular (im) injections of 2 ml each, bilaterally into the lower extremities during one procedure to evaluate the safety, tolerability, and potential activity of vlts-934 as compared with a saline placebo.

Eligibility criteria:
inclusion criteria: * diagnosis of peripheral arterial disease in both legs * history of exercise limiting symptoms exclusion criteria: * lower limb revascularization surgery with 2 months of study entry * diagnosis of critical limb ischemia

Keywords: peripheral arterial disease
efficacy of statin addition to neoadjuvant chemotherapy protocols for breast cancer

Conditions: Breast Cancer

Summary: different modalities for breast cancer treatments have exhausting and distressing side effects and toxicities leading to decreased compliance. thus, repurposing drugs with accepted safety profile and possible antitumor activity becomes an eminent constraint. statins have been reported to have possible advantages as anticancer, and control of cancer progression. moreover, they can sensitize cancer cells for radiotherapy. therefore, the investigators aim to investigate the effect of (pitavastatin) added to conventional chemotherapy protocols for breast cancer patients.


Eligibility criteria:
inclusion criteria: * provision of informed consent before any study-specific procedures. * histologic confirmation of invasive breast cancer. * plans for the administration of neoadjuvant chemotherapy. * not currently pregnant during the study exclusion criteria: * severe gastrointestinal disorder * current use of statins or fibrates for any time during the 3 months before the study * proven hypersensitivity to statins * currently on medication for hypercholesterolemia * strong cytochrome p450 3a4 (abbreviated cyp3a4) (e.g., clarithromycin, hiv protease inhibitors, and itraconazole), given potential interactions with statins * renal impairment with a creatinine \> 1.4 mg/dl * hepatic impairment: aspartate transaminase (ast)/(sgot), alanine transaminase (alt)/(sgpt) ≥ 2.5 x upper limit of the normal range (uln), or total bilirubin ≥ 1.5 x uln (subjects with gilbert's syndrome can have bilirubin of up to 1.5 x uln), or alkaline phosphatase \> 2.5 x uln * central nervous system (cns) diseases and major psychiatric diseases or inability to comply with the protocol procedures * active infections * cardiac failure, class i-iv * current anticoagulant or antiplatelet aggregation therapy * current lactation
risk prediction model for exacerbating phenotype in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease Severe

Summary: this study is planned to be conducted based on the cohort of patients with severe chronic obstructive pulmonary disease in our hospital. based on gut microbiota, random forest was used to search for potential diagnostic biomarkers in patients with frequent acute exacerbation and controls with non frequent acute exacerbation; construct a frequent acute exacerbation risk prediction model using random forest, support vector machine, and bp neural network models. the development of this study will provide valuable references for the clinical classification and prognosis evaluation of chronic obstructive pulmonary disease (copd), and improve the health level of copd patients by further searching for treatable targets.


Eligibility criteria:
inclusion criteria: 1. patients who meet the diagnostic criteria for copd of the global initiative for chronic obstructive lung diseases (gold 2022) and gold grading ⅲ - ⅳ (fev1/fvc\&lt;70%, fev1% predicted value ≤ 50% after bronchiectasis) 2. age\&gt;40 years old 3. copd stable for more than 4 weeks 4. short acting bronchiectasis was not used within 24 hours before this experiment, long acting bronchiectasis was not used within 48 hours, and glucocorticoids were not used throughout the body in the past month 5. patient informed and signed consent form exclusion criteria: 1. asthma, active pulmonary tuberculosis, interstitial pneumonia and severe bronchiectasis 2. complicated with serious diseases (acute infection, diabetes, stroke, heart disease, liver and kidney dysfunction, cancer or autoimmune disease) 3. history of chronic diarrhea or constipation 4. history of gastrointestinal surgery 5. using probiotics or antibiotics within the past 4 weeks 6. no history of using oral hormones or traditional chinese medicine in the past three months 7. pregnancy or lactation
endostar plus egfr-tki（epidermal growth factor receptor-tyrosine-kinase inhibitor） as a treatment of egfr mutation-positive nsclc

Conditions: Advanced Cancer; Lung Cancer, Nonsmall Cell

Summary: egfr tyrosine-kinase inhibitor monotherapy is widely used in treatment of patients with egfr mutation-positive non-small cell lung cancer(nsclc), in despite of the benefit of pfs （progression-free survival） , the os （ overall survival） is limited extended. this study is aim to observe the safety and efficacy of the combination of an anti-angiogenic drug recombinant human-endostatin with egfr tki ,to find out a new strategy which may further extend the pfs and os with a tolerated toxicity.


Eligibility criteria:
inclusion criteria: * advanced nsclc,egfr mutation positive,ps（performance status） 0-2,patients were required to have one or more measurable lesions exclusion criteria: -

Keywords: egfr-tki recombinant human endostatin
clinical study of the efficacy and safety of shr-1819 injection in adult patients with prurigo nodularis

Conditions: Prurigo Nodularis

Summary: this trial was designed to evaluate the efficacy and safety of shr-1819 injection in patients with prurigo nodularis.


Eligibility criteria:
inclusion criteria: 1. subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol. 2. the age was ≥18 at the time of signing the informed consent and gender is unlimited. 3. have prurigo nodularis at screening. exclusion criteria: 1. pregnant or lactating women. 2. major surgeries are planned for the duration of the study. 3. has an active skin disease (such as chronic lichen simplex, psoriasis, chronic photosensitive dermatitis, etc.) or skin complications due to other diseases that may affect the evaluation of pn. 4. history of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis. 5. treated with biologics targeting il-4rα (such as dupliumab), or participated in previous clinical studies of biologics targeting il-4rα, including shr-1819 injection. 6. screening for people with a history of heavy alcohol consumption or substance abuse in the 6 months prior to screening. 7. diagnosis of moderate to severe ad during the screening/lead-in period or prior to randomization. 8. subjects with malignancy prior to screening (except for squamous cell carcinoma of the skin, basal cell carcinoma, or carcinoma in situ of the cervix that are completely resected and have no evidence of recurrence). 9. use of other biologics (such as omalizumab) within 3 months or 5 half-lives prior to screening, whichever is longer as confirmation. 10. other conditions that, in the opinion of the investigator, are not suitable for participation in this study.
implementation of vascular care team to improve medical management of pad patients

Conditions: Peripheral Artery Disease

Summary: this study intends to evaluate the efficacy of a multidisciplinary vascular care team utilizing an intensive guideline-based lipid reduction program in improving risk factor modification as measured by ldl-c reduction at 12 months in patients with peripheral artery disease (pad). an additional objective is to understand the potential reach and impact if this program were extended across the university of colorado healthcare (uc health) system.

patients with pad and elevated ldl-c who are cared for at the university of colorado (uc) and who provide consent will be randomized 1:1 to intervention a, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus intervention b consisting of standard care augmented with a single consultation with a vascular medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 american college of cardiology (acc)/american heart association (aha) guideline on management of blood. in order to investigate the efficacy of the cpc endpoint quality intervention program (equip), subjects will additionally be randomized 1:1 to an investigative site conducted six-minute walk test or an equip team led six-minute walk test. quality of life data will be collected from all subjects. there will also be an observational cohort (registry) to understand current practice patterns and outcomes in a non-interventional pad population within the uc health system in order to assess the potential impact of intervention a after conclusion of the randomized study.

Eligibility criteria:
inclusion criteria: 1. documented lower extremity atherosclerotic pad with recommended goal ldl-c \<70 mg/dl by the acc/aha management of blood cholesterol guidelines 2. receiving care at cu anschutz 3. screening/baseline ldl-c ≥70 mg/dl without change in lipid lowering therapy within the last 30 days prior to ldl-c draw. 4. able to provide informed consent and willing to participate exclusion criteria: 1. unwilling or unlikely to remain in the uc health system through 1 year follow up (12 months after randomization) 2. life expectancy \< 12 months 3. fasting triglycerides \>400 mg/ml at screening 4. end-stage renal disease (egrf\<15 ml/min/1.73m2 and/or renal replacement therapy) 5. history of nephrotic syndrome 6. clinical evidence of severe liver disease or another medical condition for which lipid lowering therapy may be contraindicated 7. current enrollment in another investigational device or drug study with unapproved devices or therapies or with therapies that would impact lipid levels or lipid therapy 8. any other condition that in the opinion of the investigator would make the subject unable to comply with the protocol
a study of ly3561774 in participants with dyslipidemia

Conditions: Dyslipidemias

Summary: this is a 3-part study. in parts a and b, the main purpose is to evaluate the safety and tolerability of the study drug known as ly3561774 in participants with dyslipidemia (high blood fat levels). how the body processes the study drug and the effect of the study drug on blood fat levels will also be investigated. part c will mainly evaluate the safety and tolerability of ly3561774 as well as how the body processes the study drug in japanese participants. the study may last up 52, 56 and 28 weeks for each participant in parts a, b and c, respectively. there are up to 22, 26 and 16 visits in parts a, b and c, respectively.


Eligibility criteria:
inclusion criteria: * for parts a and b, have a fasting triglyceride (tg) level greater than or equal to (≥) 150 milligram/deciliter (mg/dl) and less than 500 mg/dl, as well as low density lipoprotein cholesterol (ldl-c) level greater than or equal to (≥) 70 mg/dl * for part c, participants should be first-generation japanese origin. * have a body mass index (bmi) of 18.5 to 40.0 kilograms per square meter (kg/m²) * male participants must agree to adhere to contraception restrictions and female participants must not be able to get pregnant exclusion criteria: * have taken any prescription medications that are for lowering serum tgs within the past 2 months (use of statins is allowed if the dose has been stable for 8 weeks) * have type 1 diabetes * are currently participating in or completed a clinical trial within the last 30 days * are heavy alcohol drinkers or heavy cigarette smokers * have donated blood of more than 500 millilitres (ml) in the last 3 months
a clinical trial of a new computer based intervention for children with autism.

Conditions: Autism Spectrum Disorder

Summary: the click-east research project is an investigation of the efficacy of a computer based learning programme which aims to teach the fundamental components of social attention to young children with autism spectrum disorder (asd). "social attention" describes the process of choosing to look at or listen to social information in the world, normally in preference to any other available information. social information normally refers to people: for example, we notice human voices more than birdsong or traffic noise, even if the latter is louder. as a rule, children with asd are less likely to prioritise this kind of social information. this is thought to have a significant effect on their development and behaviour. for example, a child who doesn't listen to what his parents say may be very slow to learn language, and may also fail to follow important instructions. our goal is to create a new learning programme, in the form of an enjoyable computer game, which encourages children to practise the skills of looking at and listening to people, despite the presence of distracting information. the investigators will develop the game with the input of an advisory group of parents and teachers of children with asd as well as some young adults with an asd diagnosis. then they will perform a trial of the game with a group of preschoolers with asd and their families, in order to determine whether the game is having a positive effect on the children's abilities.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of core autism * aged between 15 months and 5 years, 11 months. * minimum nonverbal age equivalent of 15 months. exclusion criteria: * children with epilepsy whose developmental progress may be impeded * families with little knowledge of the english language such that their understanding of the information sheets and instructions accompanying the trial is limited. unfortunately funding is not available for the provision of translators or translated materials.
activities for cognitive enhancement of seniors

Conditions: Aging

Summary: cognitive aging and cognitive decline are important public health concerns in an aging us population. the investigators will conduct a randomized controlled trail among healthy older adults to assess effects of several innovative activities on remediation of age-related cognitive decline.

ace-seniors is designed as a single-site trial of four randomly assigned interventions, tai chi exercise, autobiographical writing, both tai chi and autobiography (dual intervention), and general health education. participants are relatively healthy adults aged 70 years or older, who are not regular practitioners of tai chi or regular writers. they are without medical or neurological disorders that would substantially limit the ability to participate in study interventions, without dementia or mild cognitive impairment, relatively sedentary, able to walk unassisted, and able to score 4 or better on the short physical performance battery. interventions are administered over a 6 month period of time, with similar exposure times among the four groups. the prespecified primary endpoint is derived from a composite neuropsychological measure, based on three tests of executive function and three tests of episodic memory. the planned sample size is 96 (24 per group). intention-to-treat analysis will include all eligible participants who complete baseline assessments.

Eligibility criteria:
inclusion criteria: * 70 years of age or older. * no other household member already enrolled. * in reasonably good health: no serious cognitive problem; free of any condition that would limit your ability to participate in tai chi classes (a moderate intensity exercise), in qigong exercises, in a writing program, or in a seminar series. * not presently engaged in a regular exercise program; not presently engaged in tai chi qigong or another form of eastern exercise; and not a regular writer. * not now engaged in research to enhance cognitive skills. * willing to travel to stanford for ace-seniors program classes. planning to be in the area during most of the coming year; * willing to be assigned randomly (by chance) to one of the ace-senior activities. exclusion criteria: * failure to meet inclusion criteria.