Kornimate/medical-research-clean huggingface dataset:
cardiovascular outcomes study of alogliptin in patients with type 2 diabetes and acute coronary syndrome

Conditions: Diabetes Mellitus, Type 2; Acute Coronary Syndrome

Summary: the purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (qd), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor developed by takeda for use in patients with type 2 diabetes mellitus. cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus patients who have cardiovascular disease and are at high risk for major adverse cardiac events, such as those patients who have had recent acute coronary syndrome. this study has been designed to evaluate the cardiovascular safety of alogliptin versus placebo in addition to standard of care in adults with type 2 diabetes mellitus and acute coronary syndrome.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus * is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at screening (between 7.0 and 11.0%, inclusive, if the participant's antidiabetic regimen includes insulin) * diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization. exclusion criteria: * signs of type 1 diabetes mellitus * currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at screening * received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to screening.

Keywords: diabetes mellitus - type 2 diabetes mellitus cardiovascular outcomes heart attack stroke dipeptidyl-peptidase iv inhibitors metabolic disorders metabolic diseases glucose metabolism disorders
hyperbaric oxygen therapy in diabetic foot

Conditions: Diabetic Foot Ulcer Neuropathic

Summary: this study seeks to assess changes in genes that are related to inflammation and oxidative stress in patients with type 2 diabetes with diabetic foot treated with hyperbaric chamber

aims: patients with an uncontrolled glycemic index develop a wide variety of pathologies associated with diabetes, such as diabetic foot ulcers (dfus). hyperbaric oxygen therapy (hbot) is an adjunctive therapy used to help wound healing and prevent lower extremity amputations in this population. the aim of this study was to analyze the effect of hbot on the gene expression of super oxide dismutase 1 (sod1), super oxide dismutase 2 (sod2), glutathione peroxidase (gpx2), and pro-inflammatory cytokines (tnfα, il-1β, il-12, il-4, nlrp3) in patients with wagner stage ii-iv dfus. methods: the effect of hbot was evaluated in 15 patients that underwent 12 and 30 sessions in the hyperbaric chamber. blood samples were collected and relative gene expression was assessed by quantitative real time polymerase chain reaction (qpcr). in the analysis, qualitative variables are presented in frequencies and percentages, compared with the chi-square test; quantitative variables according to the shapiro-wilk normality test, normally distributed variables are presented in means and standard deviation, compared with student;s t-test, those related with anova test; quantitative variables of free distribution are presented in medians and interquartile ranges, compared with mann whitney u-test, those related with kruskall-wallis test. data analysis was carried out with spss version 23, graph pad prisma. a value p \< 0.05 was taken as statistical significance, 95%.

Eligibility criteria:
inclusion criteria: men and women with diabetic foot and hyperbaric treatment. ages 30-60 years. signed informed consent form. exclusion criteria: * patients with diabetic foot without presence of dermatologic lesions.

Keywords: gene expression hyperbaric oxygen therapy diabetic foot
effects of iron on exercise capacity during hypoxia

Conditions: Healthy Volunteers

Summary: during alveolar hypoxia, for example at high altitude or in patients with respiratory disease, there is evidence to suggest that hypoxia-induced pulmonary hypertension might limit exercise performance. intravenous iron supplementation has recently been shown to reverse pulmonary hypertension in healthy humans at high altitude, and to prevent pulmonary hypertension in volunteers exposed to hypoxia at sea level. the investigators hypothesized that intravenous iron supplementation would enhance exercise capacity during alveolar hypoxia.


Eligibility criteria:
inclusion criteria: * age between 18 and 60 years * sea level natives with no recent exposure to high altitude * baseline iron indices within the normal range * detectable tricuspid regurgitation on echocardiography exclusion criteria: * significant cardiorespiratory disease * known susceptibility to high altitude-related illness * taking medications or iron supplementation * pregnancy
a first-in-human (fih) study to evaluate the safety and tolerability of vvd-130850 in participants with advanced solid and hematologic tumors

Conditions: Advanced Solid Tumors; Advanced Hematologic Tumors

Summary: a fih study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of vvd-130850, as single agent and in combination with checkpoint inhibition, in participants with advanced solid and hematologic tumors.


Eligibility criteria:
key inclusion criteria: 1. histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-hodgkin's lymphoma (nhl). 2. eastern cooperative oncology group (ecog) performance status ≤1. 3. adequate organ and bone marrow function as defined in the protocol. 4. for combination therapy expansion: * serine/threonine kinase 11/ liver kinase b1 (stk11/lkb1) mutated non-small cell lung cancer (nsclc) as assessed by historical (local) test. * must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor (cpi). these therapies could have been given in the same line of therapy or different lines of therapy. 5. measurable disease by recist version 1.1 as assessed by the investigator. key exclusion criteria: 1. have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy. 2. prior allogeneic transplantation. 3. history of cardiac diseases as defined in detail in the protocol. 4. clinically significant infection or any eye infection. 5. active central nervous system (cns) malignancies (previously treated cns malignancies are not exclusionary). 6. combination therapy expansion: * known hypersensitivity or contraindication to pembrolizumab or any of its components. * any prior toxicity (grade 3 or 4) related to immunotherapy leading to treatment discontinuation with the exception of the history of immunotherapy-related endocrinopathy controlled with ongoing medical management (e.g., hypothyroidism, adrenal insufficiency, diabetes).

Keywords: vvd-130850 phase i first in human cancer small molecule stat3 nsclc stk11 lkb1 immunosuppression checkpoint inhibitor pd-1
study assessing pain relief after replacement of the knee

Conditions: Acute Postoperative Pain

Summary: this is a phase 2b randomized, double blind, active controlled, multi-center clinical trial to evaluate the safety and efficacy of atx-101 in participants following total knee arthroplasty. the following is short title and acronym for the study: study assessing pain relief after replacement of the knee (spark)


Eligibility criteria:
inclusion criteria: * primary indication of total knee arthroplasty is knee pain due to osteoarthritis or post-traumatic arthritis. * scheduled to undergo primary unilateral total knee arthroplasty with a cemented prosthesis, without use of a surgical drain, and under bupivacaine spinal anesthesia (dextrose is permitted). * american society of anesthesiology (asa) physical classification system of class 1, 2 or 3. exclusion criteria: * has a planned concurrent surgical procedure. * has had any previous arthroplasty, unicompartmental knee arthroplasty or total knee arthroplasty in the study knee or previous arthroplasty, unicompartmental knee arthroplasty, or total knee arthroplasty in the contralateral knee within 6 months prior to screening. * has been administered any type of intra-articular injection within 3 months of surgery in the trial knee. * immunocompromised or has a known history of hepatitis b, human immunodeficiency virus (hiv), or hepatitis c. * routinely take opioid analgesics and are expected to require opioid analgesics in the postsurgical period that is not strictly related to the trial. * unable to abstain from opioid use for knee pain within 14 days of surgery. * has been administered systemic steroids within 14 days prior to surgery. * has been administered any local anesthetic within 5 days prior to the scheduled surgery. * screening electrocardiogram (ecg) with significant abnormalities associated with significant heart disease. * has a contraindication or a known suspected history of allergy, hypersensitivity or idiosyncratic reaction to trial medications. * has uncontrolled depression, anxiety, psychiatric, or neurological disorder that might interfere with trial study assessments. * has a medical condition or receiving medication such that, in the opinion of the investigator, participating in the trial would pose a health risk to the subject or might interfere with the study outcome. * has a known or suspected history of drug or alcohol abuse. a subject with a history of alcohol use disorder that has ≥10 years sobriety will be permitted. * has received/used an investigational drug, product, or device for a clinical trial within 30 days of screening. covid-19 vaccines are permitted if the subject is not in a clinical trial for the vaccine. * has a body mass index (bmi) ≥45 kg/m2

Keywords: postoperative pain post-surgical pain total knee arthroplasty total knee replacement atx-101 bupivacaine bupivacaine implant
treatment of peripheral neuropathic pain

Conditions: Neuropathic Pain

Summary: peripheral neuropathic pain is a disabling chronic pain condition that is difficult to treat. repetitive transcranial magnetic stimulation (rtms) to the motor cortex is a treatment method with growing evidence in its ability to alleviate neuropathic pain. this also applies to new deep rtms coils which permits stimulation of larger cortical areas and with deeper penetration. the aim of this study is to investigate the analgesic efficacy of 5 days of deep rtms compared to sham stimulation. we will also assess effects of deep rtms on sleep, psychological fatctors, everyday functioning, and executive functioning.


Eligibility criteria:
inclusion criteria: * 18-80 years of age * peripheral neuropathic pain related to postherpetic neuralgia, peripheral nerve injury, limb amputation, polyneuropathy or radiculopathy, fulfilling the criteria for probable or definite neuropathic pain (finnerup et al. 2016) * usual pain intensity at least 4/10 over the past 24 hrs using the numerical scale of the bpi at screening * daily pain * pain for at least 3 months * stable pharmacological treatment for pain or no pharmaceutical treatment at least 1 month prior to inclusion participation * ability to follow throughout the whole duration of the study exclusion criteria: atients with phantom limb pain after limb amputation * any clinically significant or unstable medical or psychiatric disorder * subjects protected by law (guardianship or tutelage measure) * history of or current substance abuse (alcohol, drugs) * pending litigation * contraindication to rtms (past severe head trauma, history of epilepsy or ongoing epilepsy, active cerebral tumour, past neurosurgical intervention, intracranial hypertension, implanted devices not compatible such as cardiac pacemaker and neurostimulator, cochlear implants, pregnancy or lactation. all women of childbearing age will be required to have negative pregnancy test at inclusion and to be using contraception) * pain conditions more severe than peripheral neuropathic pain * inability to understand the protocol or to fill out the forms * other ongoing research protocol or recent past protocol within one month before the inclusion

Keywords: repetitive transcranial magnetic stimulation
cognitive functions on coronary surgery

Conditions: Neurocognitive Disorders

Summary: the aim of this study is to examine the effects of different but safe levels of arterial oxygen levels used in cardiac surgeries on cerebral oxygenation during the operation. it is also to investigate the effect on cognitive functions in the postoperative period. for our study the investigators will conduct a randomized control trial. patients will be randomly assigned to one of two possible study groups according to the arterial oxygen levels.if there is any abnormality in cerebral oxygen levels during surgery, necessary intervention will be made by doctors.

in most cardiovascular surgeries, patients are frequently followed up at hyperoxemic level for safety purposes against the risk of tissue hypoxia that may develop during surgery due to cpb use. at the level of hyperoxemia, there are opinions that the ischemia-reperfusion damage increases with the follow-up of cabg surgery, microcirculation is impaired and tissue oxygenation is impaired due to the resulting hyperoxemic vasoconstriction. recent research has focused on evaluating optimal oxygen levels in cpb during cardiac surgery. however, the potential of tightly regulated intraoperative normoxia to improve pocd following cardiac surgery has not been studied prospectively. the purpose of this study is to determine whether patients who underwent cpb and cabg, which were preserved under normoxic conditions during the intraoperative period, would have a lower incidence of early and late pocd than those exposed to hyperoxia.

Eligibility criteria:
inclusion criteria: * adult patients scheduled to undergo elective cardiopulmonary bypass graft surgery exclusion criteria: * severe preoperative cognitive impairment(i.e. dementia, intellectual disorder) * non-turkish speaking patients * presence of end-stage organ failure * patients requiring emergency coronary surgery * surgical procedures requiring single lung ventilation

Keywords: cardiovascular surgery cerebral oxymetre neurocognitive assessment
paclitaxel in treating patients with aids-related kaposi's sarcoma

Conditions: Sarcoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of paclitaxel in treating patients with aids-related kaposi's sarcoma.

objectives: * determine whether the body distribution and plasma clearance of paclitaxel is affected by protease inhibitors (e.g., indinavir, ritonavir, saquinavir mesylate, or nelfinavir mesylate). outline: patients are stratified according to protease inhibitor treatment (yes vs no), prior paclitaxel (yes vs no), and prior doxorubicin or daunorubicin (yes vs no). patients receive paclitaxel iv over 3 hours on day 1. treatment continues every 2 weeks for at least 1 course in the absence of disease progression or unacceptable toxicity. patients who previously received paclitaxel receive no more than 1 course during this study. projected accrual: a total of 33 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed kaposi's sarcoma requiring chemotherapy and/or currently being treated with paclitaxel * serologic diagnosis of hiv infection documented by a positive elisa and confirmed with a western blot or other federally approved hiv diagnostic test patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,000/mm \^3(with or without the use of colony-stimulating factors) * platelet count at least 50,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast no greater than 2.5 times uln * alkaline phosphatase no greater than 2.5 times uln renal: * creatinine no greater than 1.5 mg/dl or * creatinine clearance greater than 60 ml/min neurologic: * no greater than grade 2 peripheral neuropathy * no neuropsychiatric history or altered mental status that would preclude study other: * not pregnant or nursing * fertile patients must use effective contraception * no other prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * no sensitivity to e. coli-derived proteins * no active untreated infection * no new infectious complications requiring a change in antibiotics within the past 2 weeks prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics endocrine therapy: * not specified radiotherapy: * at least 1 week since prior radiotherapy * no prior radiotherapy to marker lesions * no concurrent radiotherapy surgery: * not specified other: * at least 2 weeks since prior systemic treatment for kaposi's sarcoma * at least 2 weeks since prior nonapproved fda investigational agents except available investigational new drugs that are antiretroviral agents * concurrent maintenance therapy for opportunistic infections allowed * concurrent commercially available antiretroviral therapy allowed

Keywords: aids-related kaposi sarcoma recurrent kaposi sarcoma
mindfulness interventions and cutaneous t cell lymphoma (ctcl)

Conditions: Anxiety; Quality of Life

Summary: the primary objective is to assess the feasibly, adherence, and effects of mindfulness-based stress reduction (mbsr) on anxiety and health-related quality of life in adult patients with cutaneous t-cell lymphoma at the yale cancer center/smilow cancer hospital. participants will attend group sessions led by an instructor experienced in mbsr in an academic setting. the mindfulness meditation group sessions will take place at the smilow cancer center at the yale new-haven hospital.

participants will attend weekly 2.5-hour group sessions (of 10-14 persons) based on the standard mindfulness-based stress reduction (mbsr) protocol. participants will be assigned home practice based on the mbsr protocol, and will be given audio recordings (mp3) to accompany and instruct in home practice. eligible participants will attend weekly group sessions for 8 weeks and will be assessed at baseline, following cessation of the intervention (8-weeks), and 16 weeks. outcomes will be assessed at baseline, 8 weeks, and 16 weeks. extended effects of the intervention will be assessed at 16 weeks.

Eligibility criteria:
inclusion criteria: * identified with lymphoma through the yale cancer center hematology clinic. * access to mobile telephone/smartphone with text messaging plan in order to receive survey questions. * current ctcl patients in dr. foss's practice at the yale cancer center. exclusion criteria: * current regular mindfulness meditation activity (weekly or more frequent practice of self-defined meditation, formalized relaxation techniques, tai chi, and meditative yoga). * inability or unwillingness to give consent. * serious illness (including mental illness/psychopathology) within 90 days prior to screening, including hospitalization for chronic disease. determination of 'serious' will be made by pi and research team. for example, unstable asthma, cancers (except non-melanoma skin cancer and ctcl), and schizophrenia will be considered 'serious,' while stable asthma, allergic rhinitis, esophageal reflux, generalized anxiety disorder, or attention deficit disorder will not be considered 'serious. * active participation (weekly or more often) in a cancer or chronic disease support group. * active substance abusers. * current suicidal ideation, operationally defined as affirmative responses on the columbia-suicide severity rating scale (c-ssrs) at screening.

Keywords: cutaneous t-cell lymphoma
prehospital cooling 1 (precool 1)

Conditions: Stroke

Summary: elevated body temperature was shown to be associated with worse outcome in acute stroke patients. precool 1 aims to investigate efficacy, feasibility and safety of prehospital cooling with cold infusions in stroke patients.


Eligibility criteria:
inclusion criteria: * suspected stroke * symptom onset ≤ 7 days * tympanic temperature ≥ 36.7°c * informed consent by the patient * age ≥ 18 years exclusion criteria: * severe cardiac insufficiency (nyha ≥ iii) * new anisocoria, severe nausea, vomiting or headache * high-grade heart valve stenosis or insufficiency * acute pulmonary embolism * acute myocardial infarction * threatening ventricular dysrhythmia * known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia) * known vasospastic vascular disorder (e.g. raynaud's phenomenon or thromboangiitis obliterans) * severe renal insufficiency with reduced diuresis * pregnancy

Keywords: ischemic stroke hemorrhagic stroke prehospital cooling induction of cooling ambulance emergency room cold infusions hypothermia normothermia
trial of a secondary stroke prevention program

Conditions: Ischemic Stroke; Transient Ischemic Attack

Summary: the purpose of this study is to determine whether an outpatient program can reduce the risk of recurrent stroke.

stroke is a major cause of death and disability. a history of stroke is the strongest predictor of a future stroke. control of risk factors lowers the risk of future stroke, yet most persons with stroke do not have their risk factors controlled. in this randomized-controlled trial, we will test whether an outpatient stroke prevention program consisting of group clinics, patient self-management, and telephone care coordination can lower the risk of recurrent stroke by improving patient knowledge, medication adherence, and lifestyle habits. if successful, this program may be adapted to other settings.

Eligibility criteria:
inclusion criteria: * ischemic stroke within the past 30 days * transient ischemic attack within the past 30 days * person receiving care at va long beach healthcare system exclusion criteria: * unable to understand informed consent * already enrolled in another research study

Keywords: chronic care model stroke prevention health services research
comorbidity and pulmonary rehabilitation in copd

Conditions: COPD

Summary: our aim in this study is to determine the distribution of comorbidity in patients with copd participating in the pulmonary rehabilitation program and to examine the effect of severity of comorbidy on pulmonary rehabilitation outcomes.

chronic obstructive pulmonary disease (copd) is associated not only with respiratory system effects but also with systemic outcomes leading to numerous chronic comorbidities, and it is well known that patients benefit from pulmonary rehabilitation programs. however, the effect of presence of comorbidity on the outcome of pulmonary rehabilitation in patients with copd is not clear. therefore, our aim in this study is to determine the distribution of comorbidity in patients with copd participating in the pulmonary rehabilitation program and to examine the effect of severity of comorbidy on pulmonary rehabilitation outcomes we included a total of 173 patients referred to the izmir suat seren chest diseases and surgery training and research hospital pulmonary rehabilitation unit. comorbidities were recorded based on self reports. charlson comorbid indexes (cci) were calculated. patients who defined at least one comorbidity were divided into two groups according to cci; 1-3 as group 1 and 4 and above as group 2. six minute walk test, mmrc dyspnea scale, sgrq respiratory disease questionnaire, respiratory function tests and arterial blood gases performed for assessment of patients before and after 16 sessions of pulmonary rehabilitation program.

Eligibility criteria: