Kornimate/medical-research-clean huggingface dataset:
study of efficacy and safety of percutaneous coronary intervention to improve survival in heart failure

Conditions: Ischemic Cardiomyopathy

Summary: this study will assess whether percutaneous coronary intervention (angioplasty of the heart arteries) can improve survival and reduce hospitalization in patients with heart failure due to coronary disease, who have been treated with the best contemporary medical therapy.


Eligibility criteria:
inclusion criteria: all of the following: 1. poor left ventricular function (ef≤35%) 2. extensive coronary disease 3. viability in at least 4 dysfunctional segments that can be revascularised by pci exclusion criteria: 1. myocardial infarction \< 4 weeks prior to randomisation (clinical definition) 2. decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or intra-aortic balloon pump/left ventricular assist device therapy \<72 hours prior to randomization 3. sustained ventricular tachycardia/ventricular fibrillation or appropriate implantable cardioverter defibrillator discharges \<72 hours prior to randomization 4. valve disease requiring intervention 5. contraindications to percutaneous coronary intervention 6. age \<18 yrs 7. estimated glomerular filtration rate \< 25 ml/min, unless established on dialysis 8. women who are pregnant 9. previously enrolled in revived-bcis2 or current enrollment in other study that may affect revived-bcis2 outcome data 10. life expectancy \< 1 yr due to non-cardiac pathology

Keywords: heart failure ventricular dysfunction ischemic cardiomyopathy ischemic heart disease revascularization percutaneous coronary intervention randomized control trial implantable cardioverter defibrillator
micrornas as diagnostic and predictive biomarkers for acute graft versus host disease

Conditions: Acute GVH Disease

Summary: the goal of this research proposal is to identify a mirna expression profile as a biomarker to diagnose and predict acute graft versus host disease (agvhd) in patients who undergo allogeneic transplantation. this biomarker, once identified, will need validation in larger cohorts.

human subjects that volunteer to participate in this study will be requested to have approximately 20 cc of blood drawn (about 12 tablespoons) at several time intervals. these time intervals include prior to conditioning regimen for transplant, the day of transplantation, day +30, +60 and +100 after transplantation. if a given subject develops acute graft-versus-host disease, a blood sample will be obtained at that time as well. the amount of blood samples collected in an 8 week period will not exceed 50 ml and collection will not occur more than twice a week. there will be no pregnant women or children involved in the investigators study. all patients involved in the study will be undergoing bone marrow transplant and pregnancy screening is done in pre-transplant testing. this blood will be collected in lavender top, edta tubes; some plasma (or serum) may be collected and stored for additional analysis.

Eligibility criteria:
inclusion criteria: * patients undergoing fully matched allogeneic pbcsc and bone marrow transplantation who present with clinical signs and symptoms of grade ii- iv agvhd within 100 days after transplantation as defined by skin, gi, and/or liver involvement that are confirmed by biopsy, regardless of age * patients undergoing a matched, unrelated donor (8/8) or matched, related donor transplant (6/6) * allogeneic transplant is from donor's peripheral blood stem cells or bone marrow transplant * patients who develop grade ii-iv agvhd exclusion criteria: * patients who receive transplants from incompletely matched donors * patients who receive t cell depleted transplants * patients who receive haplo-identical transplants * pregnant patients
web-delivered interventions for blood sugar control for individuals with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the goal of the research is to optimize an online and mobile multicomponent 12-month diet and lifestyle intervention for improving the blood glucose control of individuals with type 2 diabetes.

the research will identify the most promising intervention components. the following components will be tested: dietary adherence testing with a breath meter, text messages, and diet-appropriate foods and cookbooks. the primary goal is to optimize the intervention by examining the hba1c results at 12 months.

Eligibility criteria:
inclusion criteria: * overweight or obese * english-speaking * diagnosis of type 2 diabetes (hba1c \> 6.5%) * regular access to the internet and text messages exclusion criteria: * taking diabetes medications other than metformin * being pregnant or breastfeeding * currently undergoing cancer treatments * untreated serious mental illness
gondola mechanism of action

Conditions: Chronic Stroke; Cerebral Palsy; Parkinson's Disease

Summary: this study will investigate the clinical, functional and neurophysiological effects of automated mechanical peripheral stimulation (amps) via the gondola device administered to patients with chronic stroke, cerebral palsy and parkinson's disease. results will be collected using standardized outcome measures and a transcranial magnetic stimulation assessment protocol including electrical stimulation and electromyographic recording.

the working hypothesis for this pre-post intervention study is that one session of amps will increase voluntary motor drive of the plantar-flexors (soleus) muscle. the primary outcome measure will be maximum voluntary contraction (mvc) of the soleus (measured by electromyography, emg); the secondary outcome will be the mvc of the antagonist muscle, the tibialis anterior. data will be collected before the first session compared to directly after. the same measures in sham-stimulated and healthy volunteers will serve as controls.

Eligibility criteria:
inclusion criteria: * age 18 to 80; * chronic stroke lesion \>6 months after a cerebrovascular accident or diagnosis of cerebral palsy or parkinson's disease; * presence of some degree of motor function in the ankle flexor (soleus motor power \>1); * able to ambulate 10 meters without physical assistance. exclusion criteria: * medically unstable condition; * presence of other concurrent neurological illness; * cognitive impairment (montreal cognitive assessment score \<23); * presence of any potential tms risk factor: damaged skin at the site of stimulation; * presence of an electrically, magnetically or mechanically activated implant, an intracerebral vascular clip, or any other electrically sensitive support system; * family history of medication-resistant epilepsy; * past history of seizures or unexplained spells of loss of consciousness.

Keywords: ambulation sensory stimulation mobility neurological disorder
dc vaccine in colorectal cancer

Conditions: Colorectal Cancer

Summary: this is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mdc3 vaccine in patients with colorectal cancer.

this is a pilot study to assess the safety and tolerability, as well as the immune response rate, of mdc3 vaccine in patients with colorectal cancer. eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. each study subject will receive cyclophosphamide 300mg/m\^2 intravenously 3 to 4 days prior to the vaccine dose to deplete regulatory t cells. for each vaccine dose, all subjects will receive autologous dendritic cells pulsed with mutated peptides. on day 1, the subject will receive the primer vaccine dose; this will be followed by one booster vaccine dose approximately 8 weeks later. peripheral blood will be taken weekly, and a second apheresis procedure will be performed at the end of study to monitor the immune response to the vaccine. information will be gathered from usual clinic visits for approximately 1 year following the end of treatment study visit to evaluate for disease progression.

Eligibility criteria:
inclusion criteria: * pathologically-confirmed stage i and ii hypermutated colorectal cancer (crc) * surgically resected disease * male or female patients 18+ years of age * ecog performance status 0-1 * certain laboratory values, performed within 14 days prior to consent * subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial. * provide written informed consent exclusion criteria: * prior malignancy within 3 years that may put subject at risk * pregnant or nursing women * concurrent treatment with systemic immunosuppressants including corticosteroids, calcineurin inhibitors, antiproliferative agents within 2 weeks of consent. local (inhaled or topical) steroids or replacement dose prednisone are permitted. * known allergy to eggs * any uncontrolled intercurrent illness or active ongoing infection thta may put subject at additional risk

Keywords: colorectal cancer cancer vaccine dendritic cell vaccine
prospective randomized optical coherence tomography oslo trial

Conditions: Myocardial Infarction; Angina

Summary: coronary artery intervention with stents is a routine procedure with several clinical indications. a stentfailure, ie stentrestenosis and/or stentthrombosis will occur in some patients. several different mechanisms have been suggested. stentfailure may be caused by mechanical properties of the stent. this may be secondary to suboptimal stentimplantation, ie over/undersizing or acquired ie malapposition or stentfracture. these stentproperties may be difficult to identify with conventional coronary angiography due to low image resolution. the hypothesis of the study is that high resolution imaging with optical coherence tomography (oct) will improve diagnosis and enable a more specific or tailored treatment with a subsequent reduction in later stentfailure.

the hypothesis of the proctor study is that high resolution imaging with optical coherence tomography (oct) will improve diagnosis and enable a more specific or tailored treatment in stent failure. however, the prevalence of stentfailure (ie stent malapposition, stentfracture, stentedgedissections etc) not causing clinical endpoints is not known. in a subset of patients (n=100) with previously implanted stents performing a new coronary angiography based on clinical indication, functional or patent stents (decided by heart team) will be characterized with oct and the patients followed for 5 years. the purpose of this substudy, oct ips (oct in patent stents), is to estimate the prevalence of stentpathology in patent or functional stents and compare findings with the active arm of proctor.

Eligibility criteria:
inclusion criteria: clinical indication for coronary angiography and intervention due to stentfailure, both stentrestenosis and stentthrombosis in stable patients or unstable patients with acute coronary syndrome. exclusion criteria: * patient not able to give informed consent. * unwillingness. * life expectancy \< 5 years. * reduced kidney function with grf\<45. * coronary artery diameter \< 2.5mm. * pregnancy. * patients without 11-digit norwegian personal number.

Keywords: coronary stents
a study to assess the safety and efficacy of a tacrolimus new oral formulation (mr4) in bmt patients-extension-

Conditions: Bone Marrow Transplantation; Graft Versus Host Disease; Graft-Versus-Host Disease; Graft-Vs-Host Disease

Summary: to assess safety and efficacy of the patients with mr4 therapy in gvhd prophylaxis study who are eligible for the administration after 100 days post transplant (up to 1 year)


Eligibility criteria:
inclusion criteria: * patient had enrolled in gvhd prophylaxis study. * patient had been fully informed. exclusion criteria: * the patient had been not eligible for the administration after 100 days post transplant in the investigator's judgement.

Keywords: tacrolimus immunosuppression bone marrow transplantation graft versus host disease
atrial flutter ablation in the icmr

Conditions: Atrial Flutter Typical

Summary: the visabl-afl clinical investigation is a prospective, single-arm, multi-center, interventional, investigational device exemption (ide) trial. the primary objectives of visabl-afl are to assess the safety and efficacy of radiofrequency (rf) ablation of type-i atrial flutter performed with the vision-mr ablation catheter 2.0 in the icmr environment.


Eligibility criteria:
inclusion criteria: * patient indicated for type i atrial flutter ablations with at least 1 documented episode of type i atrial flutter within 6 months (180 days) of enrollment * patient 18 years and older exclusion criteria: * contraindications for mri procedures * patients who cannot have anti-arrhythmic drugs (class i or class iii) prescribed for the treatment of type i atrial flutter stopped on the day of the procedure * previous cti ablation procedures * myocardial infarction within 60 days of enrollment * current unstable angina * cardiac surgery within 90 days of enrollment * any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment * thrombocytosis or thrombocytopenia * contraindication to anticoagulation therapy * currently documented intracardiac thrombus or myxoma * implantation of permanent leads of an implantable device in or through the right atrium within 90 days of enrollment * prosthetic valve through which the catheter must pass * interatrial baffle or patch through which the catheter must pass * moderate or severe tricuspid valve regurgitation or stenosis * uncompensated congestive heart failure * active systemic infection * pregnancy or if subject plans to become pregnant during the trial * uncontrolled hyperthyroidism * any other significant uncontrolled or unstable medical condition * enrollment in any concurrent study without imricor written approval * life expectancy of less than or equal to 2 years (730 days) per physician opinion

Keywords: rf ablation interventional cardiac magnetic resonance (icmr)
traumatic optic neuropathy treatment trial 2

Conditions: Traumatic Optic Neuropathy

Summary: after introducing intravenous erythropoietin (epo) as an option for treatment of patients with indirect traumatic optic neuropathy in 2011 and publishing non inferiority trial in oct.2017), tontt2 is aiming to find out the best dose and timing of epo administration in this group of patients.

patients with ton will be visited. after being eligible to enter the study and obtaining informed consent, they will be randomly assigned into 3 groups of different total dose of intravenous administration of epo to which patients and outcome assessors will be masked. they will be assessed at different follow up time periods with the last follow up of at least 3 months.

Eligibility criteria:
inclusion criteria: 1. having indirect traumatic optic neuropathy(with normal eye and fundus exam) 2. trauma to treatment interval of 3 weeks and less 3. age of 7 years and more exclusion criteria: 1. direct optic neuropathy, 2. glaucoma, 3. any retinopathy 4. globe laceration 5. age under 7 6. hypertension, 7. polycythemia, 8. creatinin more than 3 mg/dl, 9. sensitivity to epo 10. patients who have received any other form of treatment for their traumatic optic neuropathy

Keywords: traumatic optic neuropathy erythropoietin epo eprex
sensitivity study of diagnostic for detection of chagas infection

Conditions: Infectious Diseases

Summary: this study is a multi-site trial assessing the sensitivity of chagas detect™ plus rapid test versus standard reference tests (e.g. ifa, iha, ripa) for chagas diagnosis. the chagas detect™ plus rapid test serves as an aid in the clinical laboratory diagnosis of chagas infection in patients. this test is intended to be used on human whole blood or serum samples. chagas detect™ plus results (positive or negative) must be confirmed by testing with a reference standard test. subjects will be patients at clinical sites located in chagas-endemic areas. after informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected. one is blood from finger prick, and the other is blood from venous puncture (drawn from vein in arm). rapid tests and reference tests will be performed by different operators who are laboratory staff members. these staff members, blinded to each other's results, will evaluate the samples from each method independently.


Eligibility criteria:
inclusion criteria: * all age groups and both sexes for archive samples, adults only and both sexes for prospective samples. * samples collected from subjects living in t. cruzi endemic regions. * information must be available about symptoms, age, and sex of patient from which samples are collected. * the location of sample collection must be recorded. exclusion criteria: * archived samples with linked personal identifiers or any sample for which personal information can be discovered. * prospective samples from nursing home residents; inmates/subjects in police custody; participants who are unable to understand verbal or written local language in which a certified translation of the informed consent is available, or requires a legal authorized representative (lar) for consent. * subject serum specimens that have undergone more than 2 freeze-thaw cycles or that have not been stored frozen.
efficacy of platelet-rich plasma in management of anosmia

Conditions: Anosmia

Summary: olfactory dysfunction is a prevalent disorder that affects up to 20% of the general population and has significant effects on a person's quality of life as well as increased morbidity and mortality (croy i et al., 2014;nordin s et al .,2008). anosmia is the inability to perceive the odor or a lack of functioning olfaction; it may be temporary or permanent. organic anosmia is loss of smell due to nasal obstruction caused by sinonasal diseases (as nasal polyps, tumors, postoperative) preventing odorant molecules from reaching olfactory mucosa. functional anosmia affects up to 5% of the general population and 10% of those older than 65 . functional anosmia is due to damage of peripheral olfactory area causing permanent loss of smell as post-traumatic, post viral infection. . 20% of individuals aged 20 to 90 years have impaired olfactory function . the etiology of olfactory dysfunction is quite varied, including post viral posttraumatic, and idiopathic loss of smell. unfortunately, with these etiologies, the likelihood of spontaneous recovery is generally poor with only approximately one-third of people regaining function and the duration of loss negatively correlating with recovery rate . treatment for olfactory dysfunction is also limited. best evidence studies recommend olfactory training and topical steroid nasal irrigations as potential therapeutics, yet both have limited efficacy . prp is an autologous materials known to have anti-inflammatory and proregenerative properties including up regulation of growth factors including transforming growth factor, vascular endothelial growth factor, epidermal growth factor, and insulin-like growth factor. it has been used as a safe therapy effective in treating inflammation, wound healing, and peripheral neuropathies in other clinical settings. in particular, prp has been shown to promote axon regeneration and neuroregeneration .


Eligibility criteria:
inclusion criteria: * sex:both gender. * upsit score up to 10 of 40 * all patients who suffer from anosmia * normal airway passage * ct free of any sinonasal obstrucive lesions. exclusion criteria: * age: below 18 years old and above 50years old. * all patients with bilateral nasal obstruction related to chronic sinusitis, bilateral nasal polyposis,septum ,turbinate hypertrophy,tumors. * upsit score more than 10 of 40. * traumatic causes of anosmia. * all patients with medical history of blood diseases and diabetic and hypertensive patients. * any medical treatment affect coagulation or bone marrow for 2 weeks prior to testing ..
sjs/ten or other cutaneous adverse eevents induced by immune checkpoint inhibitors (icis) vs. non-icis

Conditions: Immune Checkpoint Inhibitor-Induced Dermatitis; Stevens-Johnson Syndrome, Drug-Induced; Toxic Epidermal Necrolysis Due to Drug

Summary: stevens-johnson syndrome/toxic epidermal necrolysis (sjs/ten) is a severe adverse drug reaction, characterized by extensive skin detachment. with the increasing use of immune checkpoint inhibitors (icis) in oncology, it is crucial to understand the differences in sjs/ten induced by icis compared to other drugs. this study aims to compare the clinical manifestations and outcomes of stevens-johnson syndrome/toxic epidermal necrolysis (sjs/ten) or other severity of cutaneous adverse events induced by immune checkpoint inhibitors (icis), versus other types of drugs. we analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life.

introduction: stevens-johnson syndrome/toxic epidermal necrolysis (sjs/ten) is a severe adverse drug reaction characterized by extensive skin detachment. with the increasing use of immune checkpoint inhibitors (icis) in oncology, it is crucial to understand the differences in sjs/ten induced by icis compared to other drugs. this study aims to compare the clinical manifestations and outcomes of stevens-johnson syndrome/toxic epidermal necrolysis (sjs/ten) or other severity of cutaneous adverse events induced by immune checkpoint inhibitors (icis) versus other type drugs. we analyzed differences in clinical characteristics, treatment methods, outcomes, and survival time and quality of life. methods: * study design: retrospective cohort study or cross-sectional study. * participants: 60 patients with ici-induced sjs/ten and 100 to 500 patients with other drug-induced sjs/ten. * data collection: detailed medical records were reviewed to extract information. * statistical analysis: analysis using appropriate statistical tests (e.g., t-test, chi-square test). results: present the analysis results, highlighting significant differences between the two groups. use tables and graphs to illustrate key findings. conclusion: we discuss the clinical implications of the findings, potential mechanisms underlying the observed differences, and the relevance to patient management. summarize the main findings and their significance for clinical practice. emphasize the need for tailored treatment approaches based on the type of drug causing sjs/ten.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sjs/ten induced by any drugs * have the immune-related cutaneous adverse events exclusion criteria: * incomplete medical records * unknown the specific culprit drugs