Kornimate/medical-research-clean huggingface dataset:
adaption of the stair-nt trauma intervention for polysubstance populations

Conditions: Polysubstance Abuse; Posttraumatic Stress Disorder

Summary: during this 36-month r34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (ptsd) intervention (stair-nt) and layer it into a methadone maintenance treatment (mmt) program (start treatment and recovery centers) in new york city for use among individuals engaged in stimulant-opioid polysubstance use. the study aims to adapt stair-nt to a massed treatment schedule. once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and ptsd symptomology outcomes in a pilot randomized control trial (rct) of 80 participants. participants who screen eligible and consent will be randomized 1:1 to the adapted stair-nt intervention or treatment as usual (tau) using randomization blocks of two and two and four via a computer-generated randomization sequence. participants assigned to the intervention will receive the adapted massed delivery of stair-nt by trained counselors.


Eligibility criteria:
inclusion criteria: * must be 18 years or older, * be a patient at the start clinic receiving methadone for treatment of opioid use disorder, * self-report 10+ days of co-use of cocaine and illicit opioids in the past 30-days, * meet the criteria for stimulant use disorder (cocaine type; mild, moderate or severe) and a score of 3≥ on the pc-ptsd-5. exclusion criteria: * cognitive impairment that would interfere with their ability to understand study participation as assessed by the researcher, * does not speak/understand english at a conversational level, * plans to leave the start clinic in the next 60 days, * patients who missed methadone doses (inactive) for 30 days or more, or * having received clinical care from the interventionist(s) in the past 30 days
chest pain, illness perception compliance and psychosocial outcome after coronary arteriography

Conditions: Coronary Disease

Summary: chest pain, illness perception compliance and psychosocial outcome after coronary arteriography. a comparison between patients which were diagnosed with slow coronary flow and patients who have been diagnosed with coronary artery occlusion. we hope to prove that the more knowledge and awareness the patient has about his disease the better his compliance and rehabilitation.


Eligibility criteria:
inclusion criteria: * adult patients with slow flow or coronary artery occlusion exclusion criteria: * all other patients

Keywords: coronary disease psychosocial nursing
a depot formulation of sunitinib malate (gb-102) in subjects with neovascular (wet) age-related macular degeneration

Conditions: Neovascular Age-Related Macular Degeneration

Summary: the purpose of this study is to evaluate the safety and efficacy of single and repeated intravitreal injections of gb-102 in subjects with neovascular (wet) age-related macular degeneration.

in this 2-part study, part 1 is a multicenter, open-label, safety, tolerability, and systemic exposure evaluation to sunitinib in escalating doses of a single ivt injection of gb-102, while part 2 is a multicenter, double-masked, randomized (1:1:1), parallel-group, safety, and efficacy evaluation of repeated ivt injections of 2 dose levels of gb-102 compared with aflibercept.

Eligibility criteria:
key inclusion criteria: 1. males or females of any race, ≥ 50 years of age 2. presence of an active cnv lesion secondary to amd treated with at least 3 monthly injections of an anti-vegf agent (aflibercept, bevacizumab, or ranibizumab) 3. evidence of increased vascular permeability and/or loss of visual acuity key exclusion criteria: 1. history, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke 2. uncontrolled hypertension, diabetes mellitus, iop, hypothyroidism, or hyperthyroidism 3. chronic renal disease 4. abnormal liver function 5. women who are pregnant or lactating

Keywords: age-related macular degeneration choroidal neovascularization
a study of sbrt combined with puterizumab in intrapulmonary metastasis from nsclc

Conditions: Non-Small-Cell Lung Cancer

Summary: this study aims to evaluate the efficacy and safety of sbrt combined with puterizumab immunotherapy for non-small cell lung cancer with pulmonary metastases, and to determine the correlation between mrd and treatment efficacy. through single-cell sequencing and spatial transcriptome information analysis, the underlying mechanisms will be analyzed to provide a basis for improving the new precision treatment methods for tumor immunotherapy resistance.


Eligibility criteria:
inclusion criteria: 1. age≥18 2. non small cell lung cancer patients who have experienced pulmonary metastasis after pd-1 immunotherapy in the past 3. voluntarily participate in this study and sign an informed consent form 4. the presence of evaluable size and number of pulmonary metastases on chest ct 5. there are indications for lung puncture biopsy 6. general physical condition (ecog) 0-1 7. the laboratory test meets the following standards: white blood cell count\>3.5 × 109/l, absolute value of neutrophils\>1.8 × 109/l, platelet count ≥ 75 × 109/l, hemoglobin ≥ 100g/l; nr ≤ 1.5, and aptt ≤ 1.5 times the upper limit of normal value or partial prothrombin time (pt) ≤ 1.5 times the upper limit of normal value; total bilirubin ≤ 1.25 times the upper limit of normal value; alt and ast\ 50ml/min or blood creatinine\<1.5 times the upper limit of normal value. exclusion criteria: 1. unable to tolerate or refuse further immunotherapy 2. vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiteracy, etc

Keywords: lung cancer radiotherapy immunotherapy single-cell sequencing sbrt peripheral blood mononuclear cell minimalresidual disease
virtual biopsy development to identify patient's glioma grade at the chu of poitiers using magnetic resonance imaging

Conditions: Development of the Virtual Biopsy; Tumor Grade; Artificial Intelligence Algorithms; Clinical; Radiological

Summary: glioma is a tumor of the central nervous system. these lesions are sorted with the who ranking regarding the tumoral oncotype. the tumoral mri assessment is the first step before any medical decision. currently, only anatomical biopsy can give the tumor grade definition and help to define the most adapted treatment.


Eligibility criteria:
inclusion criteria: * age≥ 18 years, * patient with suspected glioma with prior imaging * subject free, with legal protection guardianship or curatorship; * enrollment in the french social security system; * informed consent signed by the patient exclusion criteria: * any contraindication to an mri examination * legal protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons residing in a health or social establishment, adults under legal protection and finally patients in emergency situations * pregnant or lactating women, women of childbearing age who do not have effective contraception
circadian ocular perfusion pressure and ocular blood flow

Conditions: Glaucoma

Summary: the purpose of this study was to compare the short term effects of two intraocular pressure (iop) lowering medications on ocular perfusion pressure (opp), ocular blood flow, intraocular pressure, and blood pressure in patients with glaucoma. ocular perfusion pressure (opp) is defined as the difference between arterial blood pressure (diastolic and systolic) and intraocular pressure. the primary efficacy assessment is based on diastolic ocular perfusion pressure.


Eligibility criteria:
inclusion criteria: * sign informed consent. * diagnosis of open-angle glaucoma in at least one eye. * requires more than one iop-lowering medication. * iop measurements at screening, safety, and eligibility/period 1 baseline visits as specified in protocol. * able to discontinue all iop-lowering medication prior to eligibility visit and for 4 weeks between treatment periods. * willing to complete all required study visits. * other protocol-defined inclusion criteria may apply. exclusion criteria: * female of child-bearing potential if pregnant, lactating, or not using highly effective birth control measures. * severe central visual field loss in either eye. * previous glaucoma surgery in the study eye. * intraocular surgery in the study eye within 3 months prior to the screening visit. * wears contact lenses. * allergy/hypersensitivity to study medication. * cannot safely discontinue use of glucocorticoid medication. * uses medication that could affect iop or blood pressure. * recent use of high-dose aspirin. * bronchial asthma or severe chronic obstructive pulmonary disease. * diabetic retinopathy. * any abnormality preventing reliable tonometry. * any severe illness or condition unsuitable for the study, in the opinion of the investigator. * other protocol-defined exclusion criteria may apply.

Keywords: glaucoma ocular perfusion pressure ocular blood flow open angle glaucoma requiring more than one iop-lowering medication
minority aids initiative retention and re-engagement project

Conditions: HIV/AIDS

Summary: the purpose of this study is to determine whether an enhanced peer intervention is effective in retaining and re-engaging at-risk people of color living with hiv/aids into care.

this is a multi-site longitudinal study of an enhanced peer intervention to re-engage and retain high-risk people of color living with hiv into hiv primary care and other needed medical or social services. three demonstration sites are implementing programs in which peers are employed as part of the health care team. peers are trained to conduct educational sessions, provide emotional support, help prepare for and accompany patients to appointments, and debrief after visits. study participants will be current or newly enrolled patients of three clinics: care resources, in miami fl, the path program at brooklyn hospital in brooklyn, ny, and pr concra located in san juan puerto rico who (1) have been out of care for 4 months or more or (2) present a need for substance abuse, mental health, or housing services. data will be collected at baseline and follow up (at six and twelve months) through client questionnaires, selected medical chart data (visit dates, laboratory tests and values) and intervention encounter forms on approximately 375 hiv positive adults. the data collected for this study will allow us to assess changes in: (a) retention in hiv primary care, (b) viral load suppression, (c) health-related quality of life, (d) self-efficacy, and (e) hiv knowledge that may be associated with an enhanced peer intervention.

Eligibility criteria:
inclusion criteria: * hiv-positive; and * age 18 years or older; and * identifies as belonging to one or more of the following racial/ethnic groups: american indian or alaskan native, asian, black or african-american, hispanic or latino, native hawaiian or other pacific islander; and * new patient to clinic (including newly-diagnosed) whose initial assessment or intake form indicates a need for substance abuse treatment, mental health or housing services, or a past history of substance abuse or mental health services; or * the individual has been out of medical care at your clinic for 4 months or more.

Keywords: hiv/aids peer support
pain intensity after root canal instrumentation

Conditions: Pain, Postoperative

Summary: assess the pain intensity in a two visit treatment of molars with irreversible pulpitis after instrumentation with two rotary systems mpro and hyflex files.


Eligibility criteria:
inclusion criteria: * mandibular molars with acute pulpitis exclusion criteria: * badly decayed non-restorable molars * medically compromised patients
elutax-sv drug-eluting balloons for below-the-knee treatment

Conditions: Critical Limb Ischemia; Peripheral Artery Disease

Summary: the aim of this observational study is to evaluate the outcomes and safety of the paclitaxel-eluted balloon catheter elutax sv for treatment of peripheral arterial disease (pad) in below-the-knee vessels

the management of critical limb ischemia due to below-the-knee disease remains challenging due to the frequent patient comorbidities, diffuse vascular involvement, limb preservation, and high rates of restenosis and disease progression. this study will record the use of elutax sv-deb under real life conditions in a representative sample.the investigators will generate new data in observing the outcome and the safety of the elutax sv drug-eluting balloons for change in rutherford clinical category from baseline to 6 and 12 month follow-up visits.

Eligibility criteria:
inclusion criteria: * paclitaxel-eluting balloon angioplasty in below-the-knee lesions with elutax sv-deb * age ≥ 18 years * signed informed consent * documented critical limb ischemia (cli) in the target limb prior to the study * rutherford category 4, 5 or 6 * ≥70% diameter stenosis or occlusion in the target lesion, including de-novo / in-stent restenosis/occlusion of target lesion * patent inflow artery * target vessel(s) diameter between 2 and 4 mm * target vessel(s) reconstitute(s) at or above the ankle exclusion criteria: * life expectancy below 50% within the next 12 months (as judged by the investigator) * planned major index limb amputation * acute limb ischemia (within last 14 days thrombectomy, atherectomy, or lysis) * application of deb-eluting balloons except from elutax sv in the same target limb (poba is allowed) * patient unwilling or unlikely to comply with follow-up schedule

Keywords: below-the-knee
use of bispectral index monitoring to detect deep sedation in mechanically ventilated patients: validity study

Conditions: Disorder; Mental, Sedative; Depressed Level of Consciousness; Mechanical Ventilation Complication; Psychosis Associated With Intensive Care

Summary: in the previous study, the investigators obtained the cutoff value of bispectral index to detect early deep sedation in patients with mechanical ventilation. bispectral index monitoring can be used as an adjunct tool in screening and confirming deep sedation during the early period of mechanical ventilation. in present study, validation test will be carried out to clarify the sensitivity and specificity of obtained cutoff value in screening deep sedation in patients with mechanical ventilation.


Eligibility criteria:
inclusion criteria: * adult patients are intubated and ventilated within the previous 24 hours, are administered with continuous or intermittent intravenous sedatives and/or analgesics, and are expected to receive mechanical ventilation and sedation for longer than 24 hours exclusion criteria: * age under 18 or over 65 years; * continuously infusion of muscle relaxants; * diagnosed or suspected brain diseases, which including brain trauma, intracranial hemorrhage, stroke, brain tumors, hypoxic-ischemic encephalopathy, epilepsy and meningitis; * diagnosed conditions that resulted in a decrease level of consciousness, which including hypoxemia with partial pressure of oxygen in arterial blood less than 60 mmhg, hypotension with systolic blood pressure less than 90 mmhg, hypoglycemia with blood glucose concentration less than 4.1 mmol/l, anemia with hemoglobin concentration less than 70 g/l, and body temperature below 36 °c.
assessing the incidence of postoperative delirium following aortic valve replacement

Conditions: Postoperative Delirium; Aortic Valve Stenosis

Summary: our primary aim in this observational study is to identify the incidence of pod in the first five postoperative days by using the 3-minute diagnostic confusion assessment method (3d-cam), the derived version for intensive care unit (cam-icu) or nurse reports in patients undergoing different techniques of aortic valve replacement. patients are followed 5 days postoperative with the 3d-cam or until resolution of pod. six months postoperatively, a follow-up by phone is planned for activity of daily living (adl).

a significant and often underrecognized complication after surgery is postoperative delirium (pod) causing increased morbidity and mortality. this is especially true for the older cardiac surgical patient, in whom the incidence of pod is up to 70%. surgical invasiveness and herewith related inflammation, a cholinergic load of medications, postoperative pain or use of opioids are examples of precipitating factors that can be altered to reduce the incidence of pod. transaortic valve replacement (tavr) is a revolutionary technique that has led to a dramatic decrease in surgical invasiveness and improved outcomes in high-risk surgical patients. however, only a few studies evaluated neurocognitive outcome after surgical aortic valve replacement (savr) compared to tavr, suggesting a reduced incidence of pod with tavr compared to savr. in contrast, other studies found almost no difference in pod in the aforementioned patient groups. hence, it remains still unclear which technique best to use in patients at high risk for pod.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo elective * tavi * savr (with or without coronary artery bypass grafting (cabg) or pulmonary vein isolation (pvi)) * patient able to read and understand the research materials exclusion criteria: * inability to give informed consent * presence of delirium at baseline as screened with the 3-minute diagnostic confusion assessment method (3d-cam) * combined surgical procedures (e.g. mitral valve surgery, aortic surgery or other)

Keywords: transaortic valve replacement surgical aortic valve replacement tavr savr
inspace™ system in comparison to best repair of massive rotator cuff tear.

Conditions: Full-thickness Rotator Cuff Tear

Summary: this is a post-marketing study to further assess the safety and effectiveness of the inspace™ device implantation in comparison to surgical repair of full thickness massive rotator cuff tear .

this is a post-marketing study to further assess the safety and effectiveness of the inspace™ device implantation in comparison to surgical repair of full thickness massive rotator cuff tear . the effectiveness will be assessed by comparing the shoulder outcome scores of each treatment arm ( ases, constant and quick dash) from pre-operation (baseline) up to 2 years post-operation, with respect to pain reduction, improvement of activity of daily living (adl) and improvement of range of motion (rom). the safety will be asses by comparing the adverse event rate between the treatment arms.

Eligibility criteria:
main inclusion criteria: * age 40 or older. * positive diagnostic imaging of the affected shoulder indicating full thickness massive rct involving more than one tendon. * persistent pain and functional disability of the affected shoulder for at least 3 months. main exclusion criteria : * known allergy to the balloon material (copolymer of pla and -θ-caprolactone). * evidence of significant osteoarthritis or cartilage damage in the shoulder * evidence of gleno-humeral instability * previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy * evidence of major joint trauma, infection, or necrosis in the shoulder * partial-thickness tears of the rotator cuff

Keywords: full-thickness/massive rotator cuff tear, sub-acromial spacer
non-idiopathic scoliosis treated with tranexamic acid

Conditions: Non-idiopathic Scoliosis

Summary: investigation of tranexamic acid (txa) for reducing perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.

to investigate whether tranexamic acid (txa) reduces perioperative blood loss and transfusion requirement in pediatric patients with secondary scoliosis undergoing posterior spinal fusion.in addition determination of the optimal txa dosing for perioperative reduction of blood loss and transfusion requirement as well as to evaluate use of thromboelastography (teg) as a measure of coagulation and fibrinolysis in pediatric patients with secondary scoliosis undergoing posterior spinal fusion (this may help guide blood product therapy). the investigation will determine the effects of txa on the teg profile and whether plasminogen activator inhibitor-1 (pai-1) level affects bleeding and transfusion requirement during scoliosis surgery. finally to investigate whether pai-1 level affects bleeding in response to txa during scoliosis surgery.

Eligibility criteria:
inclusion criteria: 1. children with secondary scoliosis undergoing posterior spinal fusion exclusion criteria: 1. known bleeding disorder as this may increase the risk of bleeding 2. current antifibrinolytic therapy as these patients may bleed less 3. patient or family history of thromboembolic disease as there may be potential risk of thrombosis 4. use of nsaids within 5 days of surgery as this may increase the risk of bleeding 5. known allergy to txa 6. history of renal insufficiency as txa is renally excreted 7. colour vision disturbance

Keywords: pediatrics scoliosis tranexamic acid investigating non-idiopathic scoliosis
inflammation in acute cardiovascular diseases - the cardiovascular inflammation registry (cair)

Conditions: Inflammation; Cardiovascular Diseases; Myocarditis; Pericarditis; Myocardial Infarction; Heart Failure; Heart Diseases

Summary: following acute cardiovascular injury, inflammation is vital to activate reparative mechanisms. however, there is compelling evidence implicating excessive inflammation and dysregulated resolution in fibrosis, ventricular remodelling, and heart failure (hf). recently, the anti-inflammatory agent colchicine reduced cardiovascular events after myocardial infarction (mi) compared to placebo, indicating that targeting inflammation in acute cardiovascular conditions is feasible. several acute cardiovascular conditions are characterised by inflammation, including myocarditis, mi, and acute heart failure. however, there is large variability in definition, epidemiology, clinical presentation, pathophysiology, and natural history of acute inflammatory cardiovascular diseases. this relates, in part, to the difficulty in performing adequately powered studies. clinical studies that include sufficient patients and extended observation periods are necessary to address some of these knowledge gaps. this registry aims to collate routinely collected clinical data on patients with acute cardiovascular diseases characterised by inflammation in an observational-based registry. by doing so, the investigators hope to understand the contribution of inflammation to the pathophysiology of acute cardiovascular disease, improve risk stratification, and identify potential novel therapeutic targets.


Eligibility criteria:
inclusion criteria: * any patient 13 years of age or older with an acute cardiovascular condition requiring hospital admission is eligible. exclusion criteria: * \<13 years of age

Keywords: inflammation acute cardiovascular disease myocarditis registry electronic health records pericarditis myocardial infarction