Kornimate/medical-research-clean huggingface dataset:
micro rnas to predict response to androgen deprivation therapy

Conditions: Prostate Cancer

Summary: identify exosomal micro rna that predict responses to adt

1. identify novel exosomal rna signatures at pretreatment that predict response to adt. the study team will collect blood samples from patients with systemic disease pretreatment (at enrollment), three months post-treatment and at the time of progression of disease (or at two years post-adt for patients still in remission at that time point) and then perform next-generation sequencing using serum exosomal rnas derived from these patients. the investigators plan to identify exosomal rnas signatures that change between pretreatment (at enrollment) and during treatment (at three months) and further explore the effect of these changes on disease response. the investigators also plan to compare exosomal rna levels between patients relapse within the first two years versus those in remission at two years. among patients with progression, the investigators plan to compare exosomal rna signatures at progression of disease to signatures at pretreatment and during treatment. 2. validate exosomal rna markers that predict response to adt by real-time rt-pcr. secondary objectives: selected rnas, identified through the above process will be validated using real-time rt-pcr assay to test reproducibility of rna sequencing results. the investigators expect to select and validate approximate five rna markers that predict duration of response to adt.

Eligibility criteria:
inclusion criteria: * histologically proven prostate cancer. * testosterone level \>30ng/ml and at least 6 months since last dose of hormonal therapy. * history/physical examination including a detailed description of the stage of prostate cancer within 8 weeks prior to registration. * ct scan of abdomen and pelvis with iv contrast and bone scan should be performed within 8 weeks prior to registration. * eastern cooperative oncology group (ecog) performance status 0-2. * age ≥ 18. * patients must provide study-specific informed consent prior to study entry for this project and mandatory blood specimen for banking for future studies (future studies may include genetic testing). exclusion criteria: * received hormonal therapy less than 6 months prior to registration. * history of active secondary malignancy. * decline hormone therapy for prostate cancer. * current or previous treatment with 5-alpha reductase inhibitors within 6 months prior to enrollment.

Keywords: prostate cancer treatment response androgen deprivation therapy
cellular immune responses to hepatitis b virus (hbv)- longitudinal follow up and natural history

Conditions: Hepatitis B; HIV Infections

Summary: it remains unclear why some individuals are able to clear hbv from their bodies while in others hbv is a persistent infection. we plan to investigate this process by collecting blood and analysing how the patient's white blood cells respond to different pieces of the hbv virus. we will use new tools that can precisely tell us which component of the immune response may be different in individuals who are chronically infected with hbv and also in individuals who are also infected with hiv. the primary aims are therefore: 1. to characterize hbv-specific t cell responses in hbv chronic carriers, and identify novel immunogenic regions in both hla-a2+ and non-hla-a2+ individuals. 2. to determine the effect of hiv infection on hbv-specific t-cell responses


Eligibility criteria:
inclusion criteria: there are two groups of patients in this study. group a mono-infected with hepatitis b, and those with co-infection hbv/hiv. group a inclusion criteria: (also split into 6 recruiting groups) * acute hepatitis b * chronic hepatitis b, hbv dna+ve , normal alt , hbeag +ve * chronic hepatitis b, hbv dna +ve , normal alt, hbeag -ve * chronic hepatitis , hbv dna +ve, increased alt, no hbv treatment b, hbeag +ve * chronic hepatitis b, hbv dna +ve , increased alt, no hbv treatment b, hbeag -ve * chronic hepatitis b, undergoing 'flare' of hepatitis group b inclusion criteria: * to be hiv/hbv co-infected all patients: * to be over 18 years exclusion criteria: * those who do not fit the inclusion criteria.

Keywords: hiv
ala on glycemic control in t2dm participants

Conditions: Type 2 Diabetes Mellitus

Summary: with the emerging worldwide epidemic of type 2 diabetes, dietary recommendations to improve diabetes management have been emphasized in the scientific community. particular attention has been drawn to various benefits of replacing saturated fatty acids with unsaturated fatty acids. alpha-linolenic acid, the only omega-3 fatty acid that is from plant sources, has been suggested by animal and cell studies to play a beneficial role in regulating blood glucose levels. however, human studies have been more inconsistent with their findings. the focus of this project is to investigate the evidence in the context of ala and blood glucose parameters in participants with type 2 diabetes by conducting a systematic review and meta-analysis of randomized controlled trials.


Eligibility criteria:
inclusion criteria: * controlled, randomized, clinical trials * trials greater than one month * focusing on ala and t2dm participants * viable endpoint data exclusion criteria: * non-human studies * non-random treatment allocation * less than 1 month * lack of suitable control * lack of endpoint data
treatment for migraine and mood (team-m)

Conditions: Migraine; Depression

Summary: the researchers propose a two-arm pilot study of telephone and video delivered mindfulness-based cognitive therapy (mbct-t and mbct-v) in people with migraine and depressive symptoms.

this study aims to set the stage for a future definitive large-scale phase iii trial in patients with migraine and depressive symptoms. this first phase is aimed at fidelity optimization of mbct-t and mbct-v in people with migraine (defined by the international classification of headache disorders - 3) and depressive symptoms (defined by empirical cut-offs on the patient health questionnaire - 9).

Eligibility criteria:
inclusion criteria: * currently meets ichd-3 criteria for migraine using the structured diagnostic interview for headache * self-reported 4-14 headache days per month, with at least one attack meeting migraine criteria * score between 5-14 on the phq-9 * age ≥ 18 * ability to read and speak english * capacity to consent exclusion criteria: * meeting ichd-3 criteria for persistent headache attributed to traumatic injury to the head (post-traumatic headache) on the structure diagnostic interview for headache * changes in preventive migraine medication or anti-depressant medication within 6 weeks of intake; changes in longer-term migraine prevention (onobotulinum toxin a, anti-calcitonin gene related peptide treatment) within 3 months of intake * comorbid psychiatric illness or clinical features that would interfere with participant's ability to participate in or receive benefit from the mbct intervention, including but not limited to: active suicidal ideation; recent history of psychosis or mania; borderline, histrionic or narcissistic personality disorder; cognitive impairment; sensory disabilities * prior history of engaging in formal mindfulness-based interventions including: mbsr, mbct, acceptance and commitment therapy, dialectical behavior therapy * current meditation practice \>3x/week
a study of the pharmacokinetic interaction between pirfenidone and bms-986278 in healthy participants

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Summary: the main objectives of this study are to characterize the pk of bms-986278 after administration of a single dose of bms-986278 alone or in combination with pirfenidone, as well as to characterize the pk of pirfenidone after administration of a single dose of pirfenidone alone or in combination with bms-986278


Eligibility criteria:
inclusion criteria: * signed informed consent. * healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations. exclusion criteria: * women of child bearing potentia (wocbp), pregnant or breastfeeding. * history of significant cardiovascular disease. * participants who have smoked or used smoking cessation or nicotine containing products within 3 months of the first dose of study. other protocol defined inclusion/exclusion criteria could apply.
impact of m-health based intervention on adherence to healthy physical activity after stroke.

Conditions: Stroke

Summary: the aim of this study is to determine the impact of an m-health based intervention on long term adherence to a rehabilitation program for stroke survivors.

this is a 8-week multimodal exercise rehabilitation program (merp) based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology. the aim of the merp is to improve walking speed, walking ability, activities of daily living and quality of life among people who have suffered a stroke. the mobile app technology complements the merp in order to achieve long term adherence to healthy physical activity.

Eligibility criteria:
inclusion criteria: * diagnosis of ischemic or hemorrhagic stroke * age ≥18; * functional ambulation classification (fac) ≥3 * barthel index ≥45 exclusion criteria: * cognitive impairment (mini mental state examination ≤24) * unstable cardiovascular disease (acute heart failure, recent myocardial infarction, unstable angina and uncontrolled arrhythmias) * alcohol or other toxic substances abuse * decompensated psychiatric disorders that prevented from following a group session

Keywords: rehabilitation exercise stroke adherence
efficacy and safety of cobiprostone in patients with portal hypertension

Conditions: Portal Hypertension

Summary: the primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.


Eligibility criteria:
inclusion criteria: * patient is \>= 18 years of age. * patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension. * patient has clinical diagnosis of cirrhosis. * patient has undergone variceal banding. exclusion criteria: * patient has a child-pugh score \>12. * patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or budd-chiari syndrome. * variceal banding procedure was performed within 1 month of the screening visit. * patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening. * patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study. * patient has hepatocellular carcinoma that is being medically treated or is advanced. * patient has impaired renal function (i.e., serum creatinine concentration \>1.8 mg/dl) * patient has a history of liver transplant, or is expected to receive a liver transplant during the study period. * patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the screening visit, or has had a bowel resection at any time.
ebus vs eus-b for diagnosing sarcoidosis

Conditions: Sarcoidosis; Endosonography

Summary: rationale: endosonography with mediastinal/ hilar nodal sampling is the test of choice to diagnose sarcoidosis stage i and ii - in case tissue verification of noncaseating granulomas is indicated. however, the optimal endosonographic approach (endobronchial or transoesophageal) for mediastinal nodal sampling is under discussion. secondly, which needle size or type provides optimal tissue sample quality for granuloma detection is unknown. the novel 25 gauge (g) beveled procore needle, allows tissue acquisition of small core biopsies in addition to cytological aspirates. hypotheses: 1. esophageal ultrasound guided (eus-b) sampling of intrathoracic lymph nodes has a 14% higher granuloma detection rate compared to endobronchial ultrasound (ebus) guided nodal sampling in patients with suspected sarcoidosis stage i/ii. 2. 25g procore needles provide superior sample quality compared to conventional 22g needles in patients with suspected sarcoidosis stage i/ii. study design: investigator initiated, randomized clinical trial. setting: international, multicenter (university and general hospitals) study population: consecutive patients with a clinical and radiologic suspicion of sarcoidosis stage i or ii and an indication for tissue verification of non-caseating granulomas are eligible for inclusion. intervention: ebus vs eus-b, simultaneously comparing the standard vs novel procore needles. main study endpoints: 1. the granuloma detection rate of endobronchial (ebus) guided sampling of intrathoracic lymph nodes compared to esophageal (eus-b using the ebus scope) guided sampling in patients with suspected sarcoidosis stage i/ii. 2. sample quality of conventional 22g vs. 25g procore needles in patients with suspected sarcoidosis stage i/ii.


Eligibility criteria:
inclusion criteria: * clinical and radiologic suspicion of sarcoidosis stage i (mediastinal or hilar lymphadenopathy) or stage ii (lymphadenopathy and interparenchymal abnormalities) * indication for tissue verification of noncaseating granuloma's * provision of a written informed consent exclusion criteria: * life expectancy of less than 6 months * obvious organ involvement of sarcoidosis with the possibility to confirm granulomas with a minimally invasive diagnostic procedure (eg skin lesion or superficial lymph node) * positive acid-fast bacilli sputum test * contra-indication for endosonography * pregnancy
anatomical and functional predictions of blindsight capabilities in patients with lateral hemianopsia

Conditions: Homonymous Hemianopia; Stroke; Cortical Blindness; Hemianopia

Summary: homonymous lateral hemianopia (hlh) is characterized by loss of vision in half the visual field, and is the most common neurovisual disorder following stroke. numerous behavioral and neuroanatomical studies have focused on the phenomenon of blindsight, corresponding to patients' unconscious residual visual capacities in the blind hemifield. cohort studies of patients have highlighted different types of blindsight, and a low occurrence of the phenomenon initially described: (1) type 1 blindsight (≈12%), unconscious visual abilities; (2) type 2 blindsight, visual abilities associated with sensations in the blind field (≈18%); (3) blindsense, sensations in the blind field without visual abilities (≈30%); and (4) no blindsight (≈40%). the heterogeneity of these blindsight abilities in the hlh population is closely related to patients' neuroanatomical and functional profiles. in particular, resting-state functional imaging (r-fmri) and default mode network analysis have highlighted a significant correlation between the degree of inter-hemispheric connection (between the healthy and injured hemispheres) and the rate of spontaneous visual field recovery. to our knowledge, this degree of functional connectivity has not yet been studied in relation to blindsight abilities. however, this functional mri measurement tool represents a potential predictive factor for patients' residual performance in their blindsight field, in order to assess the level of visuo-cognitive impairment and, ultimately, to adapt care.


Eligibility criteria:
inclusion criteria: * subjects aged 18 and over * with homonymous visual field amputation sequelae of a retrochiasmatic lesion of vascular origin (stroke), including the occipital region (primary visual cortex, optic radiations, associated occipital areas) * requires follow-up brain mri as part of treatment * able to perform experimental tasks on computer * express consent to participate in the study * member or beneficiary of a social security scheme exclusion criteria: * severe neuropsychological disorders (language, memory, attention, vigilance, reasoning) * severe ophthalmological disorders or visual acuity below 3/10 prior to stroke * progressive ophthalmological disorders (cataract or glaucoma) likely to bias measurements * major psychiatric or behavioral disorders making care impossible * patient benefiting from a legal protection measure * pregnant or breast-feeding women (declarative information)
exploratory study of ns-089/ncnp-02 in dmd

Conditions: Duchenne Muscular Dystrophy

Summary: this study is designed to assess the safety, tolerability, efficacy and pharmacokinetics (pk) of ns-089/ncnp-02 in subjects diagnosed with duchenne muscular dystrophy (dmd), and to determine the dosage for subsequent studies.


Eligibility criteria:
inclusion criteria: * has an out of frame deletion(s) that could be corrected by skipping exon 44 as confirmed by any of methodology at the time of visit 1. if not confirmed by any of methodology that evaluates the relative copy number of all exons (i.e. mlpa etc), must be confirmed through these techniques by the time of visit 3. * dna sequencing of exon 44 confirms that no dna polymorphisms occur that could compromise duplex formation between ns-089/ncnp-02 and pre-mrna. * male and \>= 8 years and \ = 4 years and \< 8 years can be enrolled according to the circumstances. * able to give informed consent in writing signed by parent(s) or legal guardian who is able to understand all of the study procedure requirements. if applicable, able to give informed assent in writing signed by the subject. * life expectancy of at least 1 year * able to ambulate. non-ambulant subject can be enrolled according to the circumstances. * have intact muscles, which have adequate quality for biopsy. (no lacks or severe atrophy of biceps brachii or tibialis anterior muscle) * qtc \<450 msec (based on 12-lead ecgs), or \<480 msec for subject with bundle branch block. * glucocorticoid-naive patients, or patients who have used systemic glucocorticoids for at least 6 months prior to enrollment in this study with no dose changes for at least 3 months prior to enrollment. exclusion criteria: * has participated in other pharmacological clinical trial that might recover dystrophin protein by the readthrough or the exon-skipping therapy, and/or upregulate the dystrophin-associated proteins such as utrophin. * a forced vital capacity (fvc) \< 50% of predicted. * continuous use of artificial respirator (except for use of nppv while sleeping) * a left ventricular ejection fraction (ef) \< 40% or fractional shortening (fs) \< 25% based on echocardiogram (echo). * surgery within the last 3 months prior to the first anticipated administration of study medication or planned for anytime between visit 1 of part 1 and the last visit of part 2. * positive hepatitis b surface antigen (hbsag), hepatitis c antibody test (hcv), or human immunodeficiency virus (hiv) test at screening. * current diagnosis of any immune deficiency or autoimmune disease. * current diagnosis of any active or uncontrolled infection, cardiomyopathy, or liver or renal disease. * use of any other investigational agents and/or experimental agents within 3 months prior to the first anticipated administration of study medication. * history of any severe drug allergy.

Keywords: duchenne muscular dystrophy
gma-tulip, i-gel and the lma-supreme (lma-s) devices in airway management

Conditions: Anesthesia; Airway Remodeling

Summary: patients were randomly assigned to three supraglottic airway devices (sads) groups for airway management after anesthesia induced. fiberoptic bronchoscope (fb) guided glottic exposure grading was performed and other airway management quality was recorded.

mechanical ventilation was volume controlled and time cycled with tidal volumes (6-8 ml/kg) set to maintain peak inspiratory pressures of less than 20 cm h2o and ventilatory frequency adjusted to maintain end-tidal carbon dioxide (petco2) at 35-45 mmhg. then a fiberoptic bronchoscope was passed through airway tube into the device to perform glottic exposure grading. peak airway pressure, incidence of pharyngalgia, bleeding, hoarseness, and dysphagia were recorded.

Eligibility criteria:
inclusion criteria: * 18-75 years old; * american society of anesthesiologists (asa) i-iii; * body mass index (bmi)\<30kg/m2; * scheduled for elective breast or lower abdominal surgery with an estimated duration of less than 4 hours; * providing written inform consent. exclusion criteria: * history of oropharyngeal surgery and anatomical abnormalities; * limited movement of the cervical spine; * high risk of reflux/aspiration; * emergency surgery; * acute throat inflammation and upper respiratory infection; * history of chronic bronchitis or asthma; * cognitive dysfunction and inability to communicate; * participating in other clinical trials.

Keywords: supraglottic airway device laryngeal inlet encapsulation lma-supreme i-gel fiberoptic alignment optimal anatomical position
peer support for increasing physical activity in people with serious mental illnesses

Conditions: Schizophrenia; Depression; Bipolar Disorder; Anxiety Disorders; Cognitive Disorders; Personality Disorders

Summary: this study will determine the effectiveness of a peer support system in increasing physical activity and effecting health behavior change in people with serious mental illnesses.

people with serious mental illnesses (smis) are, by definition, significantly functionally impaired by the illness for an indefinite period of time. schizophrenia, major depression, and bipolar disorder are considered smis. severe anxiety disorders, cognitive disorders, and some personality disorders are sometimes categorized as smis, as well. the rate of obesity among people with smis is higher than that of people without mental illnesses. this disparity may be due to the negative symptoms that people with smis experience, such as vulnerability to stress, extreme dependency, and lack of motivation. this study will design and test a culturally appropriate physical activity intervention based on a peer support model for people with smis in an urban community psychiatry program. the intervention will be evaluated to determine its effectiveness in increasing physical activity and effecting health behavior change in people with smis. participants in this 4-month, open-label study will be randomly assigned to participate in either a physical activity intervention with peer support (pa+ps) or a physical activity intervention without peer support (pa). participants in the pa+ps group will have three exercise sessions each week, which will include group exercise classes and open gym hours for supervised individual exercise. they will also meet with a peer educator once a week for 15 minutes. peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions. participants in the pa group will attend the three weekly exercise sessions but will not attend meetings with the peer educator. all outcomes will be assessed at a follow-up visit at the end of the intervention.

Eligibility criteria:
inclusion criteria: * patient at the johns hopkins community psychiatry program * plans to remain in baltimore for 8 months after study entry * if currently breastfeeding, has received approval from a physician to participate in the study exclusion criteria: * any condition that would make weight loss medically inadvisable * diagnosis of or treatment for cancer (except non-melanoma skin cancer) within 2 years prior to study entry * liver failure * history of anorexia nervosa * pregnant or planning to become pregnant during the study * inability to walk or participate in an exercise class * consumes more than 14 alcoholic drinks per week * symptoms of angina or a cardiovascular event within 6 months prior to study entry

Keywords: exercise mental illness community psychiatry peer support mental disorders