Kornimate/medical-research-clean huggingface dataset:
study of eteplirsen in dmd patients

Conditions: Duchenne Muscular Dystrophy (DMD)

Summary: the main objective of this study is to provide evidence of efficacy of eteplirsen (avi-4658) in duchenne muscular dystrophy (dmd) patients that are amenable to skipping exon 51. additional objectives include evaluation of safety, biomarkers and the long-term effects of eteplirsen up to 96 weeks, followed by a safety extension (not to exceed 48 weeks).

this is an open-label, multi-center study to evaluate the efficacy and safety of eteplirsen in patients with genotypically confirmed duchenne muscular dystrophy (dmd) with genetic deletions amenable to exon 51 skipping (treated group), with a concurrent control arm of dmd patients not amenable to exon 51 skipping (untreated group). following primary efficacy endpoints, dosing will continue to week 144 to evaluate the long term effects of eteplirsen. patients in the treated group will receive once weekly intravenous (iv) infusions of 30 mg/kg eteplirsen for 96 weeks, followed by a safety extension (not to exceed 48 weeks). patients in the untreated group will not receive treatment. clinical efficacy will be assessed at regularly scheduled study visits, including functional tests such as the six minute walk test. patients in the treated group will undergo a muscle biopsy at baseline and a second muscle biopsy over the course of the study. patients in the untreated group will not undergo muscle biopsy. safety, including adverse event monitoring and routine laboratory assessments, will be continuously monitored for all patients.

Eligibility criteria:
inclusion criteria: * male 7-16 years old * diagnosed with dmd, genotypically confirmed * stable dose of corticosteroids for at least 24 weeks * have intact right and left alternative upper muscle groups * mean 6mwt greater than 300m (primary analysis on 300 to 450 meters) * stable pulmonary and cardiac function: predicted fvc equal to or greater than 50% and lvef of greater than 50% exclusion criteria: * previous treatment with drisapersen or any other rna antisense agent or any gene therapy within the last 6 months * participation in any other dmd interventional clinical study within 12 weeks * major surgery within 3 months * presence of other clinically significant illness * major change in the physical therapy regime within 3 months other inclusion/exclusion criteria apply.

Keywords: dmd, duchenne, eteplirsen, dystrophy, dystrophin, exon 51
long term outcome after hemorrhagic stroke surgery

Conditions: Stroke

Summary: the investigators retrospectively reviewed all patients with neurosurgical operations for hemorrhagic stroke (intracerebral hemorrhage) between 1999 and 2008. research assistant then telephoned the survivors for neurological and cognitive status.

death at one year for intracerebral hemorrhage varies by location, with 42% for cerebellar in one series. of patients who had intracerebral hemorrhage in the united states during 2002, only 20% are expected to be functionally independently at 6 months. although case series established the value of selected timely hematoma evacuation, long term clinical outcome, especially on cognition, is not well described in the literature. with these in mind, we carried out this study.

Eligibility criteria:
inclusion criteria: * all hemorrhagic stroke patients with neurosurgical operations performed between 1999 and 2008. exclusion criteria: * spontaneous subarachnoid hemorrhage as the dominant etiology * uncommunicable patients * nonsurvivors

Keywords: stroke intracerebral hemorrhage surgery
zinc therapy in hiv infected individuals who abuse drugs

Conditions: HIV Infections; Substance-Related Disorders

Summary: zinc deficiency is prevalent in hiv infected individuals who abuse drugs. the purpose of this study is to determine if zinc therapy will prevent immune failure in hiv infected individuals who abuse drugs and have low plasma zinc levels.

low levels of zinc are associated with an increased risk of hiv-related death and opportunistic infections in hiv infected individuals. drug users are especially susceptible to zinc deficiency. the purpose of this trial is to evaluate the effectiveness of zinc therapy in preventing immune failure in hiv infected individuals who abuse drugs. this trial will last 30 months. participants will be randomly assigned to receive either zinc supplements or placebo. male participants will receive 15 mg of zinc and female participants will receive 12 mg of zinc. clinical and laboratory study visits will occur at 3 or 6 month intervals throughout the study.

Eligibility criteria:
inclusion criteria: * hiv infected * drug user * blood zinc level greater than 0.35 mcg/ml and less than 0.75mcg/ml exclusion criteria: * currently participating in an another clinical trial * blood selenium level less than 85 mcg/l * pregnant or intends to become pregnant

Keywords: treatment naive treatment experienced
evaluation of lamotrigine on neuropathic facial pain using fmri

Conditions: Facial Neuropathy

Summary: the aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine (trade name lamictal) on neuropathic facial pain or neuralgia using functional magnetic resonance imaging (fmri).

currently there are no pharmacological agents that can control neuropathic pain akin to the efficacy of antibiotics for bacterial infection. all current neuropathic pain drugs have approximately the same efficacy of less than 30% in controlled trials, and many of these drugs do not have known mechanisms of action. fmri studies may provide insight into how brain circuitry is altered by chronic pain, and how these drugs act on altered circuitry. the trigeminal system in particular offers unique advantages for studying such alterations, including a large central representation and high degree of somatotopy. the administration of lamotrigine to neuropathic pain patients in conjunction with fmri will allow us to compare subjective ratings of pain with objective measures of neural activity during increased conditions of allodynia/hyperalgesia.

Eligibility criteria:
inclusion criteria: * 18-60 years of age * right-handed non-smokers * diagnosed with facial pain * continuous pain for more than 3 months * spontaneous pain greater than 3 of 10 * allodynia to brush greater than 5 of 10 exclusion criteria: * medications * depression * significant medical problems * claustrophobia * abnormal ekg * significant drug or alcohol history * positive drug screen * weight greater than 285 lbs * history of allergy to anticonvulsants * tattoos with metallic ink on upper body * any neurostimulator devices, or metal cochlear, ocular, or cardiac implants or other metal near vital areas * exposure to shrapnel or metal filings * other metallic surgical hardware

Keywords: pain neuropathic face trigeminal
effect of intake of allium cepa l. peel heated water extract on immunity enhancement

Conditions: Upper Respiratory Infection

Summary: this study was conducted to investigate the effects of daily supplementation of allium cepa l. peel heated water extract on immunity enhancement

this study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 40 subjects were randomly divided into allium cepa l. peel heated water extract or a placebo group. immunity enhancement profiles before and after the intervention.

Eligibility criteria:
inclusion criteria: * age 19-75 years * symptoms of upper respiratory infection at least once within past 12 months exclusion criteria: * cardio-cerebrovascular, endocrine, immune, respiratory, musculoskeletal, inflammatory, hematologic, tumorigenic, gastrointestinal diseases, etc. * vaccination within past 2 months * bmi \< 18.5 kg/m2 or 35 kg/m2 ≤ bmi * immunity enhancement agents within past one months * allergic or hypersensitive to any of the ingredients in the test products * antipsychotic drugs therapy within past 3 months * history of alcoholism or drug abuse * participation in any other clinical trials within past 3 months * pregnant or lactating women * judged ineligible to participate in the trial by the principal investigator
methotrexate-based chemo-immunotherapy followed by maintenance therapy for patients > 65 years with central nervous system (cns)-lymphoma

Conditions: Primary Non Hodgkin Lymphoma of the Central Nervous System

Summary: the purpose of this study is to determine whether combined chemotherapy \[rituximab plus high dosage methotrexate, lomustine, and procarbazine\] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral non hodgkin lymphoma \[pcnsl\] in patients \> 65 years.


Eligibility criteria:
inclusion criteria: * first diagnosis of pcnsl, histologically confirmed * age \> 65 years * written signed and dated informed consent of the legal representative and - if possible - of the patient exclusion criteria: * manifestations of further lymphoma outside the cns * sero-positive for hiv * severe pulmonary, cardiac, hepatic, renal impairment * uncontrolled infection * neutrophil count \< 1.500/µl, platelet count \< 100.000/µl * pulmonary disease with ivc \< 55%, dlco \< 40% * cardiac ejection fraction \< 50%, uncontrolled malign arrhythmia * creatinine \> 1,5 mg% or creatinine-clearance \< 50ml/min * bilirubin \> 2mg/dl * ascites or pleural effusion (\> 500ml) * known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab, leukovorin, or dexamethasone * participation in another clinical trial within the last 30 days prior to the begin or parallel to this study * known or current drug or alcohol abuse

Keywords: pcnsl lymphoma methotrexate lomustine procarbazine rituximab elderly chemotherapy
effects of osteopathic manipulative treatment in chronic non-allergic rhinosinusitis

Conditions: Rhinosinusitis Chronic

Summary: chronic rhinosinusitis (crs) is a chronic condition with limited therapeutic options. moreover, the pathophysiology is poorly understood. the aim of this study is to evaluate the efficacy of osteopathic manipulative treatment (omt) in the course of this condition by applying several techniques supposed to be related to the autonomic nervous system. our hypothesis is that these techniques could have beneficial effects on inflammation and head symptoms in crs. methods: a sample of 90 patients diagnosed by ent specialist will be randomly assigned to the omt group or the placebo group. the placebo procedure will consist in using light touch around the nose, on the throat and on the thorax. treatment and placebo protocols are composed of two visits at day 0 and day 30. a general practitioner will determine the eligibility for the study. the outcomes include peak nasal inspiratory flow (pnif) measured five times: at day 0, 30 (twice each, before and after treatment) and 180 (once). the two groups will be compared regarding short and long term evolution. the evolution of symptoms will be assessed by the sino-nasal outcome test (snot-22) seven times: at day 0, 30, 60, 90, 120, 150 and 180. this outcome will be analyzed using mixed effect modelling a qualitative study will be conducted in the two groups to understand the patients' experiences during care. this protocol has been approved by a french ethic committee (comité de protection des personnes sud ouest et outre-mer ii, 2020.04.09).

statistical analysis details: pnif middle term evolution: if the two groups can be compared regarding their socio-demographics characteristics, a student's t-test will compare evolution (day 0 before treatment to day 30 before treatment) of the pnif between groups. if characteristics are different, a multivariate linear model will be applied. pnif long term evolution: the same tests will be made. the evolution will be assessed between day 0 (before treatment) and day 180. pnif short term evolution: the same tests will be made. the evolution will be assessed before and after treatment at day 0 and day 30. snot-22 evolution: mixed effect model will assess the evolution of symptoms from day 0 to day 180 response shift detection: for the snot-22, an oort procedure will be performed in order to detect response shift among individuals.

Eligibility criteria:
inclusion criteria: * age between 18 and 50 * chronic rhinosinusitis diagnosed by ear, nose, and throat (ent) specialist or general practitioner * informed consent given * registered under french social security system exclusion criteria: * contraindication to spine manipulation * receiving other treatment for crs during this study * being pregnant * being under legal protection * withdrawal of consent

Keywords: osteopathic manipulative treatment non-allergic rhinosinusitis chronic disease rhinitis sinusitis manual therapy osteopathy light touch
strength training induced alterations in markers of immune function

Conditions: Inflammation

Summary: exercise has been used to help prevent or slow the progression of inflammation-related disease; however, the mechanism by which this activity may lower concentrations of inflammatory markers remains unclear. the melanocortin receptors 1,3 and 5 (mc1r, mc3r and mc5r) have been shown to function in an anti-inflammatory manner and have the potential to mediate the positive immune adaptations associated with regular physical activity. preliminary data suggest that mc3r gene expression increases in whole blood after chronic exercise training. the primary aim of the current study is to explore whether this change in gene expression translates into alterations in mc1r, mc3r, or mc5r monocyte surface expression. the secondary aim is to examine the relationship between surface expression of these receptors and circulating inflammatory profiles. the investigators will recruit 42 untrained, healthy males and females aged 18-35 yrs. half of the group will be placed on an exercise program for 15 weeks. the other half will serve as untrained control subjects. in addition to basic anthropometric measures, the investigators will measure concentrations of inflammatory and anti-inflammatory cytokines (elisa) and cell surface expression of mc1r, mc3r, and mc5r on monocytes (flow cytometry).

abstract: chronic exercise reduces inflammation, but the mechanisms involved are unclear. recent studies have shown that stimulation of melanocortin 1 and 3 receptors (mc1r and mc3r) on immune cells increases anti-inflammatory cytokine production. purpose: to examine the influence of 12 weeks of resistance training (rt) on body composition, monocyte cell-surface expression of mc1r and mc3r and circulating markers of inflammation. methods: healthy, active males and females (age 20-27 yr) were recruited into a rt group (re; n = 23) and an active control group (ac; n = 19). re completed 12 weeks of progressive, periodized rt 3d/wk while ac maintained normal activity habits. measures of body composition (dxa) were taken and blood was collected prior to (pre) and following the intervention period (post). blood samples were analyzed for monocyte cell-surface expression mc1r, mc3r, mc5r and c-reactive protein (crp) and the plasma cytokines interleukin 6 (il-6) and interleukin 10 (il-10) using flow cytometry and elisas respectively.

Eligibility criteria:
inclusion criteria: * all participants must be healthy * the strength training group members must be approved for participation by a licensed md exclusion criteria: * females may not be pregnant * unhealthy participants (those with existing conditions)

Keywords: melanocortin receptor monocyte resistance training inflammation markers of inflammation
patient decision aid for opioid use disorder

Conditions: Opioid Use Disorder

Summary: the aim of the study is to test the effectiveness of the patient decision aid for opioid use disorder (ptda-mat) by conducting a stepped-wedge cluster-randomized trial in ca h\&ss (stratified by rural vs. non-rural areas) for adults with oud. patient outcomes will be tracked by (1) personal assessments (baseline, 3 months, and 6 months): drug use, overdose, healthcare utilization, and (2) clinical and administrative records (over approximately 24 months): drug treatment status and retention, physical and mental health diagnoses, arrest, incarceration, controlled substance use, and mortality. multilevel models will be applied to test the intervention effects, controlling for possible temporal trends.

in response to rfa-da-18-005 (expanding medication assisted treatment for opioid use disorders in the context of the samhsa opioid str grants, r21/r33), this project will develop and test a patient decision support tool called patient decision aid for medication-assisted treatment (ptda-mat) for use in the ca h\&ss. the ptda-mat is designed to (1) improve patient knowledge and involvement and to subsequently improve treatment adherence and outcomes and (2) to support clinicians in informing and communicating with their patients with oud along a continuum of care. the 3 year project will assess the effectiveness of the ptda-mat in a stepped-wedge cluster-randomized trial in ca h\&ss (stratified by rural vs. non-rural areas) for adults with oud. patient outcomes will be tracked by (1) personal assessments (baseline, 3 months, and 6 months): drug use, overdose, healthcare utilization, and (2) clinical and administrative records (over an average of 24 months): drug treatment status and retention, physical and mental health diagnoses, arrest, incarceration, controlled substance use, and mortality. multilevel models will be applied to test the intervention effects, controlling for possible temporal trends.

Eligibility criteria:
inclusion criteria: * opioid use disorder diagnosis and agreement to follow study procedures (including permission to share medical records and other administrative records) exclusion criteria: * significant or unstable medical or psychiatric illness that may interfere with study participation

Keywords: opioid use disorder (oud) medication assisted therapy (mat) patient decision aid medication treatment for opioid use disorder (moud)
organ donation survey among health care professionals in argentina

Conditions: Brain Death; Lung Transplantation; Respiration, Artificial; Tissue and Organ Procurement

Summary: the aim of this study is to gather information about knowledge, professional experience and attitude toward organ donation among health care professionals involved in the care of potential donors about the procurement process and potential lung donor management nationwide.

the shortage of cadaveric organ donors for transplantation is a global problem. this fact prolongs the time on the waiting list and, therefore, the mortality, which rise to 21.15% in argentina compared to a world average of 16%. many reasons can explain the low procurement rate. it has been stated that the conventional ventilatory management for potential lung donors is suboptimal for lung preservation before harvest. in argentina there is limited research regarding the attitude toward organ donation among health care professionals, knowledge of the federal organ procurement program and professional experience in diagnosing brain death and lung donor management. knowing the argentinian current situation will make it possible to detect possible organ shortages causes, evaluate strategies to increase the national procurement rate and to instruct the health team that assists neurocritical patients who die of brain death. so we propose the following research. the aim of this study is to gather information about knowledge, professional experience and attitude among health care professionals involved in the care of potential donors toward organ donation, procurement process and potential lung donor management nationwide. a online questionnaire was designed and distributed among health care professionals register to different scientific societies related to the care of neurocritical patients between febrary 16th and september 1st. the questionnaire consisting of 37 ítems: 6 items measuring attitudes, 6 items measuring knowledge, 16 items investigating professional experience and 9 ítems assessing demographics.

Eligibility criteria:
inclusion criteria: * health care professionals * register to the sociedad argentina de terapia intensiva (sati) * related to the care of neurocritical patients * between febrary 16th and september 1st. exclusion criteria: * unrelated to the care of neurocritical patients

Keywords: intensive and critical care organ donation knowledge
"real-life" cohort study on patients with chronic hbv infection in jiangsu

Conditions: Hepatitis B， Chronic

Summary: hepatitis b virus (hbv) infection remains one of the most serious health problems worldwide. patients with chronic hbv infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death. although some predictive factors of the outcome of chronic hbv infection were identified, more precisely determine the factors which are associated with the outcome in non-selected patients with chronic hbv infection are still needed. the investigators purpose is to constitute a observational cohort of non-selected chinese patients to create a database of epidemiological, clinical, biological, virological, immunologic and therapeutic parameters, in order to determine factors associated with the outcome of chronic hbv infection.


Eligibility criteria:
inclusion criteria: * patients with chronic hbv infection (defined as hbsag positive for at least 6 months) exclusion criteria: * co-infection with human immunodeficiency virus (hiv), hepatitis c virus (hcv) and/or hepatitis d virus (hdv) * history of liver transplantation * history of hepatocellular carcinoma (hcc)
xience prime everolimus eluting coronary stent system (eecss) china single-arm study

Conditions: Angioplasty; Cardiovascular Disease; Coronary Artery Disease; Coronary Heart Disease; Coronary Restenosis; Myocardial Infarction; Stent Thrombosis; Vascular Disease

Summary: abbott vascular (av) obtained marketing approval for the xience prime everolimus eluting coronary stent system (xience prime eecss) in china from the china food and drug administration (cfda) on august 10th, 2011. this prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the xience prime eecss in a cohort of real-world patients receiving the xience prime eecss during commercial use in real-world settings in china. this study has no primary outcome measure. all observations are of equal weight.


Eligibility criteria:
inclusion criteria: * the patient must be at least 18 years of age at the time of signing the informed consent. * the patient or his/her legally-authorized representative signs the european commission (ec)-approved informed consent form (icf). * only xience prime stent(s) is (are) implanted during the index procedure. exclusion criteria: * no other exclusion criteria are specified for this study.

Keywords: xience prime eecss xience v eecss xience prime spirit prime xience prime sv (small vessel) xience prime ll (long lesion) coronary artery disease coronary heart disease cardiovascular disease myocardial infarction stent thrombosis