Kornimate/medical-research-clean huggingface dataset:
anodal tdcs with compensatory audio-visual training for acquired visual field defects after brain injury

Conditions: Stroke; Hemianopsia, Homonymous

Summary: homonymous visual field defects (hvfds) following acquired brain lesions affect independent living by hampering several activities of everyday life. available treatments are intensive and week- or month-long. transcranial direct current stimulation (tdcs), a plasticity-modulating non-invasive technique, could be combined with behavioral trainings to boost their efficacy or reduce treatment duration. some promising attempts have been made pairing occipital tdcs with visual restitution training, however less is knows about which area/network should be best stimulated in association with compensatory approaches, aimed at improving exploratory abilities, such as multisensory trainings. in the present double-blind, sham-controlled study, we assess the efficacy of a multisensory training combined with tdcs. 3 groups of participants with chronic hvfds underwent a 10-day (1.5 hrs/day) compensatory audio-visual training combined with either real anodal tdcs applied to the ipsilesional occipital tdcs (group 1), or the ipsilesional posterior parietal cortex (group 2), or a sham, placebo, tdcs (group 3). the training require the participants to orient their gaze training spatio-temporally congruent, cross-modal, audio-visual stimuli (starting from a central fixation) and press a button as quick as possible upon the detection of the visual stimulus. all stimuli are presented on 2mx2m panel embedded with 48 leds and loudspeakers (bolognini et al., 2010, brain research) all participants underwent a neuropsychological assessment of visuospatial functions prior to the beginning of the training (t0), at the end of the training (t1), and at 1-month (t2) and 4-month follow-up (t3). the assessment includes: a visual detection task, three visual search tasks (ef, triangles, and numbers; bolognini et al., 2005, brain), and a questionnaire about functional impact of the hvfds in the activities of daily living.


Eligibility criteria:
inclusion criteria: - presence of chronic (\>3 months) hvfd according to neurophtalmological evaluation, due to acquired brain injury (i.e., stroke, traumatic brain injury, brain tumor) exclusion criteria: * presence of hemispatial neglect (indexed by pathological asymmetries on paper-and-pencil tests) * disorders of conjugated eye movements * other neurological disorders (e.g., dementia) * exclusion criteria for brain stimulation (i.e., epilepsy or family history of epilepsy; implanted electrodes, stimulators, pacemakers, infusion pumps, or any implanted metal device; pregnancy)

Keywords: homonymous visual field defects hemianopia compensatory training audio-visual multisensory training tdcs
safety study of abatacept to treat refractory sarcoidosis

Conditions: Sarcoidosis

Summary: the purpose of this study is to determine how safe and effective abatacept is in treating patients who have progressive pulmonary sarcoidosis.


Eligibility criteria:
primary inclusion criteria: * diagnosis of sarcoidosis for at least 1 year with lung disease * active disease despite current treatment * on a stable dose of sarcoidosis treatment with oral steroids, methotrexate, or hydroxychloroquine, for at least 90 days primary exclusion criteria: * previous treatment with abatacept * currently receiving or received within the last 60 days the following: tnfα-inhibitors (infliximab, etanercept, adalimumab) * currently receiving or received within the last 30 days the following: cyclosporine, tacrolimus or leflunomide * previous treatment of ivig within the last 6 months * history of chronic infection that has been active within last 60 days, or herpes zoster within last 6 months, or any infection requiring hospitalization or intravenous medication within last 60 days or oral medication within the last 2 weeks * history of congestive heart failure * hiv
effect of adrenocorticotropin injection with weekly interferon beta in patients with relapsing remitting multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to evaluate whether the use of acth in addition to avonex is effective in the treatment of relapsing remitting multiple sclerosis.

multiple sclerosis (ms) is a chronic, immune-mediated disease of the central nervous system (cns). it is a complex, multi-factorial disease that includes inflammatory and neurodegenerative processes manifesting both focally in the form of lesions and diffusely in otherwise normal-appearing brain tissue. recent data shows that acth can have beneficial effects on specific neurodegenerative diseases and it may have superior neuroprotective effects. adding a regimen of acth to standard avonex treatment may provide neuroprotection and promote remyelination.

Eligibility criteria:
inclusion criteria: * patient diagnosed with ms according to mcdonald criteria * age 18-65 * have a rr disease course * have edss scores 0-5.5 * have a disease duration \<20 years * sub-optimal response to interferon beta-1a i.m. (avonex®) while being on therapy for at least 6 months defined as: * presence of a documented relapse within the last 12 months * or the presence of at least one enhancing t1 gd lesion on an mri performed within previous 3 months * signed informed consent * normal kidney functioning (creatinine clearance \>59) * none of the exclusion criteria exclusion criteria: * presence of relapse or steroid treatment within 60 days prior to study enrollment * presence of neutralizing antibodies to ifnβ-1a i.m. prior to study enrollment * presence of optic neuritis within less than 6 months prior to study enrollment * diagnosis of osteoporosis (t score ≥2.5 sd) * women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study. * abnormal blood tests, performed during the screening visit including: hepatitis b or hepatitis c, alt or ast greater than two times the upper limit of normal, abnormal glucose fasting levels or already known diabetes * history of depression while on ifnβ-1a i.m.

Keywords: multiple sclerosis relapsing remitting rrms
phase ⅰa clinical trial of a pneumococcal vaccine

Conditions: Pneumonia; Respiratory Tract Diseases; Respiratory Tract Infections

Summary: infections with streptococcus pneumoniae often cause serious health problems, especially for infants and the elderly.failure to cover all polysaccharide types is an even greater problem with adults than with children. the aim of the study is to preliminary evaluate the safety and immunogenicity of pbpv vaccine compared to placebo,in order to provide a basis for subsequent clinical trial design.

the polysaccharide vaccine protected 60% of elderly adults who were at risk for pneumococcal infection.however, pneumococci are highly diverse with respect to their capsular types , and the polysaccharide-protein conjugate vaccines will not protect against strains of the many capsular types not included in the vaccine.this experimental vaccine was covered 70% of all pneumococcal types, subjects will receive three doses of pbpv vaccine on day 0,60 and 120 with different contents of 20μg,50μg,100μg each antigen in 18 to 49 years of age.

Eligibility criteria:
inclusion criteria: * healthy volunteers aged 18 to 49 years old; * willing to provide proof of identity; * able to understand and sign the informed consent; * able and willing comply with the requirements of the protocol exclusion criteria: * hypertensive volunteers with uncontrollable medications (on-site measurement: systolic blood pressure \> 140 mmhg, diastolic blood pressure \> 90 mmhg); * abnormal changes of laboratory measures (with clinical significance); * woman is pregnant and lactating (by urine pregnancy test) * suffered from pneumonia in the past three years; * invasive diseases caused by streptococcus pneumoniae (such as meningitis, bacteremia, pericarditis, peritonitis, etc.) in the past three years; * allergic person; * any prior administration of blood products in last 3 month; * any prior administration of other research medicines in last 1 month; * plans to participate in or is participating in any other drug clinical study; * any prior administration of attenuated live vaccine in last 14 days; * any prior administration of subunit or inactivated vaccines in last 7 days; * had fever before vaccination, volunteers with temperature \>37.0℃ on axillary setting; * according to the investigator's judgment, the volunteers have any otherfactors that make them unfit to participate in the clinical trial

Keywords: vaccnie pspa pneomolysin
cancer related cognitive impairment after chemotherapy: evaluation of potential therapeutic interventions

Conditions: Cognitive Impairment

Summary: background: mindfulness has been applied to improve after cancer care by enhancing psychological well-being; however, little is known about its impact on cognitive impairment experienced by cancer patients after chemotherapy. mindfulness may be relevant in tackling cognitive impairment by decreasing emotional distress and fatigue, by decreasing inflammation, and by strengthening brain functional connectivity. the aim of the present study protocol is to evaluate the efficacy and mechanisms of a mindfulness-based intervention to reduce cognitive impairment in breast-cancer patients after chemotherapy. methods: the present study is a three-group randomized controlled trial with assessments at baseline, one-three weeks after the intervention and at three months follow-up. one hundred twenty breast cancer patients who ended treatment minimum 6 months and maximum 5 years before and who have cognitive complaints will be enrolled. they will be randomized into one of the following three study arms: (1) a mindfulness-based intervention group (n=40), (2) an active control condition based on physical training (n=40), or (3) a waitlist control group (n=40). both the mindfulness-based intervention and the active control condition exist of four group sessions (3 hours for the mindfulness condition and 2 hours for the physical training) spread over 8 weeks. the primary outcomes will be cognitive complaints as measured by the cognitive failure questionnaire and changes in brain functional connectivity in the attention network. secondary outcomes will be (1) levels of emotional distress, fatigue, mindfulness; (2) neurocognitive tests; (3) structural and functional brain changes using mr imaging, and (4) inflammation. discussion: the study will examine the impact of a mindfulness-based intervention on cognitive impairment in breast-cancer patients. if the findings of this study confirm the effectiveness of a mindfulness-based program to reduce cognitive impairment, it will be possible to improve quality of life for ex-cancer patients. we will inform health care providers about the potential use of a mindfulness-based intervention as a non-pharmaceutical, low-threshold mental health intervention to improve cognitive impairment after cancer.


Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer at an early stage with or without solitary metastases (except solitary brain metastases) * completed treatment (surgery and chemotherapy) minimum 6 months and maximum 5 years before * significant cognitive complaints as measured by the cognitive failure questionnaire (cfq total score \> mean study ponds + 1 sd or on 2 or more of the cfq extra questions (t/e) \> mean study ponds + 1 sd; (ponds, van boxtel, \& jolles, 2006)) * have sufficient understanding of dutch exclusion criteria: * a history of mental retardation, psychiatric and or neurological disorder * previous participation in a mindfulness training
a comparison of two target mean arterial pressures in the resuscitation of hypotensive trauma patients

Conditions: Hemorrhagic Shock; Trauma; Wounds, Penetrating; Shock, Traumatic; Multiple Trauma

Summary: the goal of this study will be to determine if a lower than normal blood pressure during surgery for bleeding in the abdomen or chest will result in decreased bleeding and decreased chance of death.

for the proposed study, all trauma patients undergoing laparotomy or thoracotomy for trauma that had a systolic blood pressure \< 90 mmhg prior to going to the operating room will be randomized to one of two groups. the randomization will take place at the operating room door. the first group will have a target minimum mean arterial pressure of 50 mm hg (lmap) and the second group will have a target minimum mean arterial pressure of 65 mmhg (hmap). before the operating room and in all other aspects of their care the patients will be treated as per standard of care. patients will then be followed to determine if there is a difference in 30 day survival between the two groups. secondary outcome measures will be sequential organ failure assessment (sofa) score, apache ii, ards, icu length of stay, myocardial ischemia, stroke, acidosis, coagulopathy by conventional labs and thromboelastogram, estimated blood loss, transfusion requirements, glasgow outcome score, the presence of leukocyte apoptosis, the serum level of the pro-inflammatory cytokines, il-6 and g-csf, and the rate of infectious complications (vap, uti, wound infections). blood samples (20 ml each) will be taken at three time points: prior to randomization, immediately after the end of resuscitation protocol, and 24 hrs after randomization. blood will be examined for the presence of leukocyte apoptosis and levels of il-6 and g-csf.

Eligibility criteria:
inclusion criteria: * all adult patients seen in the ben taub emergency center that have suffered a trauma, have a systolic blood pressure less than 90mm hg, and are going to the operating room for a laparotomy or thoracotomy exclusion criteria: * known or suspected head injury * age \> 45 years old, \<= 12 years old * incarcerated individuals * pregnant women * patients with an advanced directive that refuse resuscitation * patients with "opt-out" bracelets that signify their refusal of participation in the project

Keywords: hypotensive resuscitation hypotensive anesthesia hemorrhagic shock penetrating trauma
radial access for navigation to your chosen lesion for peripheral vascular intervention: reach pvi

Conditions: Peripheral Artery Disease

Summary: the objective of this study is to evaluate acute clinical results of orbital atherectomy (oa) via radial artery access, including complication rates and cost effectiveness.

the purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy (oa) via transradial access (tra) for treatment of peripheral artery disease (pad) in lower extremity lesions.

Eligibility criteria:
inclusion criteria: 1. subject is ≥ 18 years 2. subject is willing and able to sign the irb-approved informed consent form (icf) 3. subject presents with a rutherford classification of 2 to 5 4. subject has a positive allen's test 5. subject to undergo peripheral angiography and/or pvi via tra approach per physician discretion index procedure inclusion criteria: 1. physician obtains successful radial artery access (note: snuffbox access is allowed) 2. target lesion appropriate (i.e. location/morphology) for oa treatment via tra within target area 3. oas use attempted (defined as viperwire introduced into the body) exclusion criteria: 1. subject has no palpable radial artery on the planned access arm 2. subject has a previous failed radial access attempt on planned access arm 3. subject has a dialysis fistula on planned access arm 4. subject has a known subclavian stenosis or occlusion 5. subject has a previous subclavian stent or previous subclavian intervention 6. subject has a shunt in the radial artery on the planned access arm 7. subject has evidence of osteomyelitis 8. subject is currently participating in an investigational drug or device study 9. subject is pregnant within the study period index procedure exclusion criteria 1. physician unable to obtain radial artery access 2. physician determines tra is not acceptable due to patient anatomy, lesion characteristics, and/or disease severity 3. oas use not attempted (defined as viperwire introduced into the body) prior to insertion of viperwire: 4. femoral access is obtained 5. unsuccessful peripheral intervention 6. a reportable adverse event has occurred
effect of remote ischemic preconditioning on electrophysiological and biomolecular parameters in non-valvular paroxysmal atrial fibrillation: rippaf study

Conditions: Atrial Fibrillation

Summary: the aim of the study is to examine the effect of ripc on physiological parameters in non-valvular paroxysmal atrial fibrillation. furthermore the study will provide a unique bio-date base for further analysis of molecular and genetic mechanisms responsible for observed results. the potential effect of ripc on af inducibility and/or prothrombotic activity might be implemented as additional treatment component to reduce af burden and minimize thromboembolic risk. interim analysis will be done after 73 patients.


Eligibility criteria:
inclusion criteria: * planned invasive atrial fibrillation ablation exclusion criteria: * af in ecg at admission * history of af ablation * age \<18 * pregnancy * neoplastic disorders * acute or systemic inflammation, autoimmune diseases * documented atrial flutter

Keywords: atrial fibrillation
v501 efficacy study in women aged 18 to 26 (v501-027)

Conditions: HPV Infections

Summary: a study to evaluate the efficacy, immunogenicity, safety and tolerability of v501 in adult women


Eligibility criteria:
inclusion criteria: * female subject aged 18 to 26 years * with 1-4 lifetime sexual partners exclusion criteria: * male subject
utilizing ct based imaging parameters of body composition to understand heterogeneity of response to biologic therapies in severe asthma cohorts

Conditions: Asthma

Summary: this study will utilize university of michigan emr data to form a retrospective cohort of severe asthma patients on biologic therapies for asthma with computed tomography (ct) imaging and known outcomes on therapy. these images will then be analyzed using morphomics, a combination of high-throughput image analysis and deep learning techniques, to derive imaging biomarkers that will be able to predict therapeutic response to biologics. these biomarkers will then be tested in a second cohort from the national jewish health to assess for validity.

the two arms for this study represent the two cohorts: the university of michigan cohort, and the national jewish health cohort. the cohorts were split into arms, as the national jewish health cohort was intended to act as a validator group for results derived from participants in the university of michigan cohort.

Eligibility criteria:
inclusion criteria: * asthma diagnosis defined as a positive methacholine test, supportive pfts, or clinician diagnosis with appropriate supporting clinical context * prescribed and taking an fda-approved biologic medication for severe asthma (mepolizumab, benralizumab, reslizumab, omalizumab, or dupilumab) * chest computerized tomography (ct) images taken for any clinical purpose exclusion criteria: * 10-year history of smoking * evidence of emphysema on ct imaging * severe bronchiectasis secondary to other causes (subjects with scattered bronchiectasis secondary to severe asthma will not excluded) * lack of accessible adequate follow-up information (4 or more months from drug initiation with clear documentation of response) will be excluded from final analysis due to inability to assess response but will be included in the initial cluster identification
bilateral; flank study with crown cooling insert

Conditions: Body Fat Disorder

Summary: evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flank using an applicator with and without the crown cooling insert.

this study will evaluate the zeltiq coolsculpting system when used with the standard coolcore applicator and the coolcore applicator and the crown cooling insert accessory.

Eligibility criteria:
inclusion criteria: * male or female subjects \> 22 years of age and \< 65 years of age. * subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment. * no weight change exceeding 5% of body weight in the preceding month. * subject with body mass index (bmi) up to 30. bmi is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. * subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study. * subject has read and signed the study written informed consent form. exclusion criteria * subject has had a surgical procedure(s) in the area of intended treatment. * subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment. * subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months. * subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. * subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. * subject has a known history of raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. * subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. * subject is taking or has taken diet pills or supplements within the past month. * subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion). * subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system * subject is pregnant or intending to become pregnant during the study period (in the next 5 months). * subject is lactating or has been lactating in the past 6 months. * subject has a history of hernia in the areas to be treated. * subject is unable or unwilling to comply with the study requirements. * subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. * any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.