Kornimate/medical-research-clean huggingface dataset:
defining endpoints in becker muscular dystrophy

Conditions: Becker Muscular Dystrophy; Muscular Dystrophies; Muscular Dystrophy in Children; Muscular Dystrophy, Becker

Summary: this is a 24-month, observational study of 50 participants with becker muscular dystrophy (bmd)

becker muscular dystrophy (bmd) is most frequently due to in-frame mutations in the dystrophin gene that are associated with reduced levels of frequently shortened dystrophin, though other mutations may be related to the becker phenotype. there is wide variation in the age of onset and degree of progression, ranging from childhood to late adulthood. the more severe form of dystrophinopathy, duchenne muscular dystrophy, has a more characteristic rate of progression and overall natural history. the wide variation in severity of progression has led to challenges in the design and conduct of approaching therapeutic trials. there is a need for a more rigorous natural history study to assist in the design of these promising therapeutic trials.

Eligibility criteria:
inclusion criteria: for ages 6-12 1. clinically affected (defined as weakness on bedside evaluation in a pattern consistent with bmd) 2. genetic confirmation of an in-frame dystrophin mutation 3. ambulatory 4. willing and able to give informed consent and follow all procedures and requirements for ages 13 and older 1. clinically affected (defined as weakness on bedside evaluation in a pattern consistent with bmd) 2. genetic confirmation of a dystrophin mutation 3. willing and able to give informed consent and follow all procedures and requirements for participants in the mri substudy: 1. ambulatory, defined as able to walk 10 meters without assistive devices (orthotics allowed) exclusion criteria: for ages 6-12 1. out of frame dystrophin mutation 2. use of chronic corticosteroids at baseline, defined as greater than 6 months of chronic use, will be limited to 20% of the overall population 3. non-ambulatory, defined as the inability to walk 10 meters without assistive device (excluding orthotics) 4. \>16 hours of ventilatory support 5. any other illness that would interfere with the ability to undergo safe testing or would interfere with interpretation of the results in the opinion of the site investigator. 6. under the age of 6 at time of enrollment 7. for mr cohort: have contraindications to mri or mrs (e.g., non-mr compatible implanted medical devices or severe claustrophobia) for ages 13 and older 1. loss of ambulation prior to age 16 2. use of chronic corticosteroids, defined as greater than 6 months of chronic use, will be limited to 20% of the overall population 3. less than 30% of the overall population will be non-ambulatory, defined as the inability to walk 10 meters without assistive device (excluding orthotics) 4. \>16 hours of ventilatory support 5. subjects aged 13-16 only: time to rise \>10 seconds 6. for mr cohort: have contraindications to mri or mrs (e.g., non-mr compatible implanted medical devices or severe claustrophobia)

Keywords: clinical research bmd becker muscular dystrophy edgewise therapeutics
efficacy and safety of firebird 2 stent in treatment of complex coronary lesions in diabetes

Conditions: Coronary Artery Disease

Summary: the goal of this study is to assess the long-term efficacy and safety of firebird2 cobalt-chromium（cocr）-alloyed sirolimus-eluting stent in treatment of complex lesions in diabetes.

this clinical trial is an international multi-center prospective clinical registry research, for evaluating the efficacy and safety of firebird 2 cobalt-chromium alloyed sirolimus-eluting stent in treatment of complex coronary lesions in diabetes. as planned, about 57 research centers all over china, latin america and asia-pacific areas will be involved and, 1300 patients will be enrolled into this research. the implanted stents must all be firebird2 cobalt-chromium alloyed sirolimus-eluting stent. the patient enrollment will last for 12 months. clinical follow-up will be done respectively for 30 days, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months. all quitted patients during the study will not be replaced with any substitutes, but categorized in the enrollment failure column. the researcher must state clear the reason of nonenrollment.

Eligibility criteria:
inclusion criteria: * definitely diagnosed type 2 dm either before or during the current hospitalization and with complex coronary lesions * the coronary lesion is complied with the definition of complex type. (defined by protocol) * the investigator admitted patients which are suitable for implanting firebird2 cocr-alloyed sirolimus-eluting stent(ses) * patient or his/ her legal supervisor are provided with informed consents. exclusion criteria: * women during pregnancy and breast-feeding; * st-segment elevated mi occurred within 1 week; * graft lesion after the coronary artery bypass graft(cabg) operation; * patient with other brand of stent implanted; * lvef ≤ 35%; * renal insufficiency before operation (serum creatinine ≥ 177umol/l) * impaired fasting glucose（6.0mmol/l～7.0mmol/l）or impaired glucose tolerance（ogtt 2h blood glucose 7.8mmol/l～11.1mmol/l）patient; * recent pci within 6 months or previous intravascular radiotherapy; * predicted life span is less than 12 months; * patient allergic to the following materials: aspirin, heparin, clopidogrel, cocr alloy, contrast agent or sirolimus. * recent participation of trial medication or other device study without endpoints completion or it is clinically interfering fire2-diabetes study endpoints. * considered by other investigators unsuitable for implanting firebird2 cocr-alloyed ses * patients could not obey the study rules, such as not understanding the study manner, scope or its outcome, not cooperative, not providing the informed consent, not accepting follow-up, not finishing the whole study procedure.
palatal lengthening using buccinator myomucosal flaps with furlow z-plasty technique for primary cleft palate repair

Conditions: Cleft Palate, Unilateral, Complete

Summary: : cleft palate is a congenital deformity caused by abnormal facial development during intra-uterine life. worldwide, the prevalence of cleft lip/palate is about 1:1000 live births. the levator vela palatini muscles are malpositioned sagittally, running postero-anteriorly and inserted onto the posterior edge of the hard palate in cleft palate patients . this configuration prevents the muscle from exerting its upward, backward, and lateral pull. various modalities have been described with major refinements over the past 30 years. gradually, cleft surgeons began to appreciate the importance of dissection and retro-positioning of the levator muscle on improving speech outcomes. furlow was the first to describe the palatoplasty technique, in which the levator muscle is dissected and freely released from its abnormal position and retro-positioned in a z-plasty lengthening technique without dissection on the hard palate. however , among the problems that have been raised concerning the furlow palatoplasty is the limitation of the procedure in wide clefts. furthermore, the possibility of higher fistula rate associated with the technique. these considerations have led to modified palatal lengthening by buccinator myomucosal flaps which is this study working on.


Eligibility criteria:
inclusion criteria: * patients in the age frame between 9 months and 18 months. * cleft palate alone or cleft lip and palate patients. * patients who have not done any previous palatal repair * haemoglobin level above 10 grams. * weight above 10 pounds. exclusion criteria: * syndromic patients. * medically compromised patients contradicting operation.
community-based, client-centered prevention homes to address the rural opioid epidemic- aim 3

Conditions: Drug Use Disorders; Hepatitis C; Harm Reduction; Opioid-use Disorder

Summary: the goal of this study was to effectively use a client-centered community-based intervention to engage people who inject drugs (pwids) in healthcare that helps reduce risky behaviors and lower infectious disease risks. participants in the intervention group of this study received a 12-week intensive multilevel harm reduction case-management intervention at three rural vivent health offices. service coordination aimed to reduce human immunodeficiency virus (hiv), hepatitis c virus (hcv), and overdose risks in pwids. prevention navigators (pns) at each office helped to coordinate referrals to reduce substance use disorder and increase engagement in the substance use disorder care cascades.

this project was conducted by an experienced, interdisciplinary team working across academic, public health, and non-government sectors. the main community partner vivent health, formerly known as the aids resource center of wisconsin (arcw), is a unique, state-wide organization that provides harm reduction services, including syringe services and confidential hiv and hcv testing, to clients at 10 fixed sites and numerous mobile units reaching all 72 wisconsin counties. based on the investigators' preliminary studies and prior collaborations, the investigators selected 6 counties in rural wisconsin. the client-centered prevention home intervention model was implemented at 3 vivent health field offices in 3 of these counties, and 3 other counties served as "usual services," or control sites. participants in the intervention underwent a 12-week intensive multilevel harm reduction case-management intervention geared towards coordinating referrals to reduce substance use disorder and increase engagement in the substance use disorder care cascades, and reduce vulnerability to hiv, stis, and hcv and increase in engagement in the hiv, sti, and hcv care cascades. participants in the intervention arm worked with prevention navigators to undergo a risk assessment and identify problems and create goals that they want to achieve. each session after that was used to review the needs assessment and goals. during their last meeting, participants and prevention navigators developed a discharge plan that will enable the participants to work on their goals on their own. participants at all six sites were offered rapid testing for hiv, hcv, and stis, and fill out survey questionnaires to evaluate risk behaviors, intervention effectiveness, and general needs of the communities.

Eligibility criteria:
inclusion criteria: * has injected drugs in the past 30 days, resides in wisconsin, over 18 years of age * able to read and write in english exclusion criteria: -
investigation of factors associated with preserved cognitive function in bipolar disorder

Conditions: Bipolar Disorder

Summary: bipolar disorder (bd) ïs the fourth leading cause of disability worldwide among young people. differences in demographic and clinical characteristics between patients do not influence educational achievement and receipt of disability pension, indicating that there are other factors such as neurocognitive function that are of importance for maintaining occupational and social function. research has shown that at the group level, cognitive deficits are present in euthymic bd patients, while approximately 30%-50% of bd patients is not different from healthy controls when it comes to cognitive function. there is however little knowledge of risk and resilience factors for cognitive impairment in bd. factors likely to contribute to cognitive and functional outcomes in bd, such as sleep, obesity, biological rhythms, comorbid medical and psychiatric conditions are also understudied. while it has been customary to focus research on factors related to the negative illness trajectories, the overarching aim of the current project is to explore factors associated with favourable outcomes. this shift in research focus is essential to elucidate factors related to more preserved function since this represents a clear gap in knowledge today.

this is an observational and prospective study aimed at identifying risk and resilience factors for cognitive impairment in bd. the investigators will enrol 85 participants with bipolar disorder. the assessment period is from one up to two weeks. at inclusion, the investigators will examine other psychiatric conditions, known somatic diseases and symptom levels of depression and hypo-/mania. insomnia severity and risk factors for metabolic syndrome will also be assessed. secondly, the investigators will examine sleep and activity extensively with both subjective and objective measures for one to two weeks. third, a newly developed web-based neuropsychological test protocol will be used shortly after assessment of sleep and activity to test cognitive function. fourth, alcohol use, substance use and biological rhythms will be assessed. lastly, the investigators will retest cognitive function and symptom levels up to five years after enrolment.

Eligibility criteria:
inclusion criteria: * individuals aged \>=18 years who score \<= 16 on the madrs or \<= 8 on the ymrs. * willing and able to give online informed consent. exclusion criteria: * symptom level above inclusion criteria will be put on a waiting list, and if informed consent is given, will be included when symptom level is reduced. * no norwegian fluency.

Keywords: cognition cross-sectional studies
use of public access defibrillators by untrained bystanders

Conditions: Cardiac Arrest; Sudden Death, Cardiac

Summary: survival from out-of-hospital cardiac arrest is time critical and diminishes rapidly without appropriate intervention. bystander cpr at least doubles the chances of survival and the additional use of a public access defibrillator (pad) can again double overall survival rates. pads are designed to be easy and simple to use, but whether untrained bystanders can use them safely and effectively is unknown. this study will aim to assess the ability of untrained bystanders to deploy a pad in a simulated cardiac arrest.

survival from out-of-hospital cardiac arrest is time critical and diminishes rapidly without appropriate intervention. overall survival is no more than 10% in the uk. bystander cpr at least doubles the chances of survival and the additional use of a public access defibrillator (pad) can again double overall survival rates. because pads can make such a dramatic increase in chances of survival, public health programmes have encouraged the deployment of pads in areas of high public density in order to deliver early defibrillation prior to ambulance arrival. where this can be achieved, survival rates as high as 50% have been reported. pads are designed to be easy and simple to use, and in addition to graphical instructions on the device, give verbal instructions to a rescuer in order to ensure the pad is used correctly. most bystanders who are first on scene at a cardiac arrest have no first aid training and it is not always possible to wait for someone with first aid training to be available to use a pad. several guidelines, such as those from the resuscitation council (uk), state that untrained bystanders can use a pad, but there has been little evaluation to understand whether this can safely and effectively be achieved without specific pad training. this study will aim to assess the ability of untrained bystanders to safely and effectively deploy a pad in a simulated cardiac arrest, specifically aiming to identify differences between the features of different devices that improve their ease of use in order to understand what design features are required for optimal design.

Eligibility criteria:
inclusion criteria: * members of the public who have never received any first aid (cpr) training exclusion criteria: * those less than 16 yrs age * those with any physical disability precluding the use of a pad
determine safety and effectiveness of tadalafil in asian men when taken as needed for getting and keeping an erection

Conditions: Impotence

Summary: study to determine if tadalafil works better than placebo for asian men having trouble getting or keeping an erection.


Eligibility criteria:
inclusion criteria: * history of erection problems * anticipate a monogamous female sexual relationship * abstain from other erection treatments at least 4 weeks before first dose and throughout the study * must be able to make required sexual intercourse attempts exclusion criteria: * other primary sexual disorders * history of radical prostatectomy or other pelvic surgery that affected being able to have an erection * history of penile implant or clinically significant penile deformity * nitrate use * certain heart problems
time-restricted eating, exercise and cardiometabolic health in obesity

Conditions: Time Restricted Feeding; Exercise; Hepatic Steatosis; Cardiometabolic Syndrome; Obesity

Summary: in spain, overweight and obesity prevalence is reaching 70% in men and 50% in women. excess of triglycerides are usually stored in the subcutaneous adipose tissue (sat), until a point where sat is unable to expand further. therefore, lipids are deposited in visceral and other peripheral organs and tissues that are not otherwise designed for adipose storage such as the liver, pancreas or the skeletal muscle, a process known as ectopic fat deposition. "time-restricted eating" (tre) is a recently emerged intermittent fasting approach which has the potential to maximize the beneficial metabolic effects extensively reported for energy intake restriction. furthermore, exercise reduces hepatic steatosis and improves cardiometabolic health in humans. however, whether the effects of tre combined with exercise on reducing hepatic steatosis are superior to tre or exercise intervention alone remains unknown. the tempus study will investigate the effects of a 12-week tre combined with supervised exercise intervention, as compared with tre or exercise alone, and usual-care control group, on hepatic fat (primary outcome) and cardiometabolic health (secondary outcomes) in adults with obesity; and to unveil the role of gut microbiota.


Eligibility criteria:
inclusion criteria: * aged 25-65 years. * body mass index ≥28.0 and \<40.0 kg/m2. * weight stability (within 5% of screening weight) for \>3 months prior to study entry. * habitual eating window ≥11 hours. exclusion criteria: * history of a major adverse cardiovascular event, clinically significant kidney, endocrine, or neurological disease, bariatric surgery, hiv/aids, known inflammatory and/or rheumatologic disease, cancer, or other medical condition in which fasting or exercise is contraindicated. * type 1 or type 2 diabetes. * major psychiatric disorders, eating disorders, sleep disorders, or alcohol abuse. * regular use of medication or compounds that may affect study outcomes (e.g., antidiabetic, steroids, beta-blockers, antibiotics, prebiotics, probiotics and symbiotics). * participating in a weight loss, a weight-management program or a supervised exercise program (more than 30 minutes three times per week, or 45 minutes twice a week, moderate/vigorous intensity). * pregnancy and lactation or planned pregnancy (within the study period). * caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. shift workers with variable hours (e.g., nocturnal). * frequent travel over time zones during the study period. * fear of needles and claustrophobia to magnetic resonance imaging (mri). * being unable to understand and to accept the instructions or the study objectives and protocol.
the clinical course of coronary artery disease in coronary multidetector computed tomographic angiogram

Conditions: Atherosclerosis; Cardiovascular Diseases; Coronary Artery Disease

Summary: study type: observational study design: observational model: defined population observational model: natural history time perspective: longitudinal time perspective: prospective

the natural history of individual plaques is unknown and needs to be established. multidetector computed tomography (mdct) angiography is a useful noninvasive imaging modality for assessing coronary plaque. using mdct, the researchers prospectively investigate the relationship between the presence of coronary plaques and cardiovascular events

Eligibility criteria:
inclusion criteria: * patients with known or suspected coronary artery disease exclusion criteria: * irregular heart beat * known allergy towards the contrast agent * renal dysfunction * impossible breath-hold * acute coronary syndrome patient
a study of targeted radiation therapy in people with non-small cell lung cancer (nsclc)

Conditions: Non Small Cell Lung Cancer; Non Small Cell Lung Cancer Metastatic; Non-small Cell Carcinoma; NSCLC; NSCLC Stage IV

Summary: the purpose of this study is to see whether adding liver stereotactic ablative radiotherapy/l-sabr to standard drug therapy is better than standard drug therapy alone for people with metastatic non-small cell lung cancer/nsclc.


Eligibility criteria:
inclusion criteria: * be greater than 18 years of age on day of signing informed consent. * have a histologically confirmed diagnosis of stage iv nsclc (includes patients who have progressed on durvalumab for stage iii nsclc) without known mutations in (egfr) or braf or rearrangements in alk (anaplastic lymphoma kinase) or ros-1. * newly diagnosed metastatic non-small cell lung cancer (nsclc), including both de novo and secondary metastatic disease, with one or more liver metastases * plan to initiate standard of care anti-pd-(l)1 based immunotherapy +/- platinum based chemotherapy for at least 3 cycles o regimens combining anti-ctla-4 immunotherapy with anti-pd-1 (e.g., ipilimumab plus nivolumab) or anti-pd-l1 (e.g., tremelimumab plus durvalumab) immunotherapy are allowed. * have a performance status of 0-2 on the ecog performance scale. * liver function tests: * total bilirubin ≤ 1.5 x uln * ast/ alt ≤ 5 x uln * eligible for l- sabr to all liver metastases. * patients with known hiv are eligible provided they are under treatment with effective anti-retroviral therapy with cd4 \>200 cells/microliter ≤ 28 days prior to registration exclusion criteria: * patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included. * patients with prior external beam radiation therapy to the liver. * patients with known active hepatitis b or hepatitis c. * patients with immunosuppression including pharmacological immunosuppression with chronic steroids or immune modulators like cyclosporin or methotrexate and patients with active autoimmune disease. * patients who are pregnant or breastfeeding * men or women not using effective contraception.

Keywords: non small cell lung cancer non small cell lung cancer metastatic non-small cell carcinoma liver stereotactic ablative radiotherapy l-sabr nsclc nsclc stage iv memorial sloan kettering cancer center 22-368