Kornimate/medical-research-clean huggingface dataset:
screening programme for abdominal aortic aneurysm by hand-held-ultrasonography in primary health care

Conditions: Abdominal Aortic Aneurysm

Summary: to determine the prevalence of abdominal aortic aneurysm (aaa) in the spanish men over 60 years through a screening program in primary health care using a hand-held ultrasound and to analyze the relationship between cardiovascular risk factors and cardiovascular disease in patients with aaa.

study includes a cohort of men over 60 years attented in primary health care centers of consorci d'atenció primària de salut d'eixample (capse).general practitioners complete an ultrasonography training in an ultrasound unit under supervision of experienced radiologists using a standard ultrasound equipment and hand-held ultrasound (trademark: vscan, manufacturer: general electric, usa). all images and video are blindly evaluated by a radiologist in order to establish the concordance in the interpretation of images between general practitioners and radiologist. kappa index will be used to study the agreement on the presence or absence of aaa. multivariate logistic regression analysis will be used to determine the factors that influence the presence of aaa.

Eligibility criteria:
inclusion criteria: * men 60 years or more * attending at primary health care center for any complaint exclusion criteria: * subjects being hemodynamically unstable at presentation * subjects with previous aaa confirmed by abdominal ultrasound scan or another image diagnosis technique * subjects deemed to require emergent treatment at presentation or after initial history and physical examination.
impact of intraoperative non-invasive analgesia monitoring using nociception level index on patient management

Conditions: Pain; Anesthesia; Perioperative Care

Summary: this prospective randomised clinical trial aims to assess the impact of intraoperative nociception monitoring using nol on anesthetic management during major abdominal surgery. additionally, the study will objectively evaluate using nol how intravenous lidocaine administration, influences opioid requirements and the effect of this multimodal approach on early postoperative outcomes. the investigators hypothesize that nol-guided intraoperative opioid administration reduces both intraoperative and postoperative opioid use, positively influencing 24-hour outcomes. furthermore, the addition of intraoperative lidocaine in nol-guided analgesia may further decrease opioid consumption.


Eligibility criteria:
inclusion criteria: * age \> 18 years * asa score i-iii * surgery for gastric or hepatobiliary or pancreatic neoplasia exclusion criteria: * pregnancy * lactation * neuraxial or regional anesthesia * chronic treatment with drugs that can influence autonomic nervous system * diuretics or nitroglycerin administration on the day of surgery * severe neurological disability * severe hemodynamic instability * chronic pain * chronic opioid treatment * allergy to any of the study drugs * severe untreated disease or organ failure * pacemaker * emergency surgery * patient refusal to participate
phase i study of mk-0683 in combination with bortezomib in participants with multiple myeloma (mk-0683-098)

Conditions: Multiple Myeloma

Summary: the primary purpose of this clinical study is to determine the recommended clinical doses of vorinostat (mk-0683) and bortezomib administered in combination to participants with relapsed and/or refractory multiple myeloma (mm). it was hypothesized that administration of vorinostat in combination with bortezomib is sufficiently safe and tolerated well enough to permit further study in participants with relapsed and/or refractory mm. study results are based on data collected up to the data cut-off date of 20-march-2011.


Eligibility criteria:
inclusion criteria: * is ≥20 years of age. * has an established diagnosis of mm based on the myeloma diagnostic criteria * has received at least 1 but not more than 3 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen * has adequate organ function exclusion criteria: * has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation during the study * has known hypersensitivity to any components of vorinostat or bortezomib * has active hepatitis b or c, plasma cell leukemia, or is human immunodeficiency virus (hiv) positive * has had prior treatment with vorinostat or histone deacetylase (hdac) inhibitors
cogmed training effect in hypertensive patients with cognitive impairment

Conditions: Hypertension

Summary: systemic arterial hypertension is a disease with high prevalence in several countries, including brazil. many studies have correlated hypertension with accelerated loss of cognitive function, especially executive functions. there is some evidence that working memory (wm) is compromised in these populations. however, some computerized training has been developed to rehabilitate the wm, and among them the investigators highlight the cogmed. thus, the aim of this study is to evaluate the effects of cogmed training in the performance of wm and attention of hypertensive patients, as well as the impact of training in the structure and brain function.


Eligibility criteria:
inclusion criteria: * individuals of both genders, of any ethnicity * signing the consent form * access to computer with internet at home * inexperienced to computerized cognitive training * hypertensive pre-diagnosed * basic schooling of four years * cognitive impairment exclusion criteria: * marked functional limitation * cognitive limitation or serious communication * severe neurological and psychiatric diseases * stroke history, head trauma or substance abuse

Keywords: hypertension cognition computerized training cogmed
study of ifn-α combined with car-t cell therapy in relapsed and refractory acute lymphoblastic leukemia（r/r-all）

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: the purpose of this study is to evaluate the safety and efficacy of ifn-α combined with car-t cell therapy in relapsed and refractory acute lymphoblastic leukemia (r/r all).

this is a phase 2, single-center study. the patients will receive ifn-α combined with infusion of car t-cells in r/r b-all patients. the study participation will be 5 years including treatment and follow-up periods.

Eligibility criteria:
inclusion criteria: 1. diagnosed refractory and relapsed acute b-lymphoblastic leukemia. 2. age 12-65. 3. eastern cooperative oncology group (ecog) score 0-2. 4. target on leukemia is \>20% positive detected with flowcytometry. 5. patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade i/ii cardiovascular dysfunction according to the new york heart association classification. 5.patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dl. 6.no other immunotherapy was received within 3 months. exclusion criteria: 1. patients are pregnant or lactating. 2. patients with congenital immunodeficiency. 3. patients with central nervous system leukemia. 4. patients with uncontrolled active infection. 5. patients with active hepatitis b or hepatitis c infection. 6. patients with hiv infection. 7. patients with atrial or venous thrombosis or embolism. 8. patients with myo-infarction or severe arrythmia in the recent 6 months. 9. other comorbidities that investigators considered not suitable for this study.

Keywords: ifn-α, car-t
herpeselect® express rapid test study protocol: sexually active adult population

Conditions: Herpes Simplex Virus 2

Summary: this study is designed to compare the performance of the focus diagnostics' herpeselect® express, a herpes simplex virus 2 rapid test, to a currently marketed device. the intent is to show the rapid test device is comparable to the currently marketed device. herpeselect® express is a rapid test intended for qualitatively detecting the presence or absence of human igg class antibodies to herpes simplex virus type 2 (hsv-2) in human whole blood (capillary).

the objective of this study is to establish the performance characteristics of the focus diagnostics (focus) herpeselect® express based on comparison to the focus diagnostics' herpeselect® 2 elisa igg (k021486). the focus herpeselect® 2 elisa igg device is intended for qualitatively detecting the presence or absence of human igg class antibodies to hsv-2 in human sera. positive samples in either the herpeselect® 2 elisa igg or herpeselect® express will be tested in the herpeselect® immunoblot (k000238). this external study along with in-house analytical studies will demonstrate the efficacy of the herpeselect® express rapid test device as an aid in screening for pregnant women or sexually active adults as in the presumptive diagnosis of hsv-2 infection for point-of-care testing sites as well as hospital/clinics and reference laboratories. independent sites in the southeastern, western, eastern, and pacific northwestern u.s. will test subjects with the herpeselect® express rapid test. sera from those patients will be tested at focus diagnostics reference laboratory in the herpeselect® 2 elisa igg. discrepants between herpeselect® express rapid test and herpeselect® 2 elisa igg may be tested in the herpeselect® immunoblot igg assay. test subjects will be from three patient populations: 375 sexually active adults, 375 pregnant women, and 100 low prevalence adults. two samples types will be collected from each subject: capillary whole blood and serum. these samples types will be tested with both the herpeselect® express rapid test and herpeselect® 2 elisa igg.

Eligibility criteria:
inclusion criteria: * sexually active adults - intercourse in the last twelve months with at least one sexual partner. * subjects must be ≥ 18 years old. * no more than 60% of one gender. exclusion criteria: * \<18 years old

Keywords: herpes simplex virus 2 hsv 2 antibody status to herpesvirus 2, human
a multislice computed tomographic study of the sphenoid sinus

Conditions: Nasal Disorder

Summary: •sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone tissue that separates it from the surrounding important structures .detailed, meticulous preoperative radiological study of sphenoid sinus is the key to successful and safe functional endoscopic sinus surgery and transsphenoidal surgery. the purpose of the study is to delineate the sphenoid sinus radiologically using the multislice computed tomography and to decrease morbidity and mortality during skull base surgeries as the sphenoid sinus is one of the most variable of all sinuses and its relation to vital vascular and nervous elements make its approach a challenge for endoscopic surgeons

sphenoid sinus is located in the body of sphenoid bone, closed with a thin plate of bone tissue that separates it from the surrounding important structures such as the optic nerve, optic chiasm, cavernous sinus, pituitary gland, and internal carotid artery. detailed, meticulous preoperative radiological study of sphenoid sinus variations as in onodi cells (sphenoethmoidal air cell) is an anatomical variant of the paranasal sinuses, important due to its close proximity to the optic nerve and internal carotid artery. , pnumatization pattern as the extent of pneumatization is highly variable and potentially jeopardizing to surrounding vital structures , septation pattern , intercarotid distance (in millimeters), bony covering of carotid artery, bony covering of optic nerve.is the key to successful and safe functional endoscopic sinus surgery and transsphenoidal surgery. the purpose of the study is to delineate the sphenoid sinus radiologically using the multislice computed tomography and to decrease morbidity and mortality during skull base surgeries as the sphenoid sinus is one of the most variable of all sinuses and its relation to vital vascular and nervous elements make its approach a challenge for endoscopic surgeons

Eligibility criteria:
inclusion criteria: * patients with free sphenoid sinus exclusion criteria: * pathology in the sphenoid sinus * refusal of patients for inclusion in the study
mesenchymal stem cells for treatment of refractory acute graft-versus-host disease

Conditions: Acute Graft-versus-host Disease

Summary: the purpose of this study is to evaluate the utility of treating patients experiencing refractory acute graft-versus-host disease with ex-vivo-expanded bm-drived mesenchymal stem cells from third-party donors. the objective was to evaluate the effect and safety of such treatment on refractory acute graft-versus-host disease.

allogeneic hematopoietic stem cell transplantation(allo-hsct) can cure many hematologic diseases. although great progress has been made in the prevention and treatment of side effects associated with transplantation,acute graft-versus-host disease(agvhd) remains an important complication that occurs in 35-80% patients. the mortality of agvhd is positively correlated with its severity. at present, glucocorticoids is still the first line treatment of agvhd. if glucocorticoids treatment is ineffective, second line drugs would be taken, such as tacrolimus(fk506), mycophenolate mofetil (mmf)and antithymocyte globulin (atg). however, no method could be continuously effective. the effective rates of second line treatment to agvhd is only about 60%. the effective rates and prognosis of refractory agvhd are even worse. mesenchymal stem cells (mscs) are a form of multipotent adult stem cells that can be isolated from bone marrow (bm), adipose tissue, and cord blood. clinical applications of human mscs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating gvhd after allo-hsct and so on. however, the efficacy of treatment of refractory agvhd using expanded bm-derived mscs from a third-party donor is rarely reported. if such treatment could be shown to be effective and safe, bm-derived mscs could potentially be used as an universal donor material. this would have a major impact because the generation of donor-specific mscs is time-consuming, costly, and often impractical if the clinical status of a patient is urgent. in the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded bm-derived mscs from third-party donors in treating patients with refractory agvhd.

Eligibility criteria:
inclusion criteria: * a patient age of 12-65 years * recipients of allogeneic hematopoietic stem cell transplantation * patients with refractory agvhd * on a voluntary basis, patients are divided into mscs and non-mscs group * subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)

Keywords: hematopoietic stem cell transplantation mesenchymal stem cells acute graft-versus-host disease
tele-rehabilitation versus home exercise program in covid-19

Conditions: Pulmonary Rehabilitation; COVID-19

Summary: the aim of the study is to investigate the potential effects of face-to-face supervised tele-rehabilitation to home exercise program on walking speed, handgrip strength, muscle endurance, quality of life, physical activity level and perceived respiratory disability in covid-19 patients who hospitalized in icu due to ards and discharged from hospital.

covid-19 could cause respiratory distress in a minority of cases and requires intensive care and mechanical ventilation. when patients recover and are discharged from hospital, physical, cognitive and emotional complications known as post-intensive care syndrome is seen in the majority of patients and requires rehabilitation. pulmonary rehabilitation is a comprehensive intervention consists of assessment of patient, exercise training and education in order to improve physical and psychological condition of people with chronic respiratory disease. the patients with covid-19 with post-intensive care syndrome will be randomized two groups: tele-rehabilitation group and home exercise group. there will not be a non-exercising control group due to the ethical issues. the exercise program of both groups will be prescribed by a physiatrist based on the physical examination and the functional capacity of the patients. tele-rehabilitation group will perform the exercise program 3 days/week for 10 weeks. one session will include aerobic, flexibility and strengthening exercises for lower and upper extremity and breathing exercise. the trainings will start with low-intensity exercises and intensity and duration of the exercises will progress according to the condition of the patient. intensity of the exercises will be monitored by borg scale based on dyspnea and exertion symptoms during the sessions. home exercise group will perform the exercises at their home on their own, 3 days/week for 10 weeks. the patients will be trained about the individualised exercise program as the first session provided at the hospital. the physiotherapist will call the patients weekly, modifications in the exercise program will be made according to the patient's reports. outcomes will be measured at baseline, within 1 week of completion the program, 6th months and 12th months following the rehabilitation.

Eligibility criteria:
inclusion criteria: * to be older than 18 years * to be discharged from icu with a diagnosis of ards or severe pneumonia due to covid-19 * to have ability to walk independently exclusion criteria: * to have dementia or cognitive impairment, symptomatic psychiatric illness, hearing or visual impairment that might interfere to follow the instructions * to have a severe co-morbidity that exercise is contraindicated

Keywords: pulmonary rehabilitation covid-19 pulmonary exercise post-intensive care syndrome
efficacy and tolerability of entospletinib in combination with systemic corticosteroids as first-line therapy in adults with chronic graft versus host disease (cgvhd)

Conditions: Chronic Graft Versus Host Disease

Summary: the primary objective of this study is to evaluate the effect of entospletinib (ento) on the best overall response rate in adults with chronic graft versus host disease (cgvhd) who are currently receiving systemic corticosteroids as part of first-line therapy for cgvhd.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent * male or non-pregnant, non-lactating, females * newly diagnosed cgvhd defined by: * at least 100 days after receiving any allogeneic hematopoietic stem cell transplant and * receiving a new course of systemic corticosteroids (≥ 0.5 mg/kg/day) as first-line cgvhd therapy at least 1 day and no more than 21 days prior to first dose of ento/placebo and * moderate to severe cgvhd as assessed by nih cgvhd diagnosis and staging criteria (ncdsc) with at least three organ systems involved or one organ system with a score of 2 or lung organ score = 1 * individuals who have undergone transplant for hematologic malignancy are required to be in complete remission. * have either a normal ecg or one with abnormalities that are considered clinically insignificant by the investigator in consultation with the sponsor key exclusion criteria: * inability to begin systemic corticosteroids therapy at a dose of ≥ 0.5 mg/kg/day (or equivalent) * uncontrolled infection within 4 weeks prior to randomization * history of the following therapies in the post-transplant period: * b cell depleting biologic agents * cd19 car-t cells based therapies * btk/syk/jak/pi3k inhibitors * phototherapy-unless administered for acute gvhd * treatment of cgvhd with anti-thymocyte globulins (atg), or campath within 60 days of screening visit unless used for treatment of acute gvhd * severe organ dysfunction manifested during screening period: * requiring supplemental oxygen at more than 2 l/min * uncontrolled arrhythmia or heart failure note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: chronic graft versus host disease (cgvhd) newly diagnosed cgvhd immune reconstitution immune system diseases allogeneic stem cell transplantation syk inhibitor
abscopal effect of radiotherapy and nivolumab in relapsed hodgkin lymphoma after anti-pd1 therapy

Conditions: Classical Hodgkin Lymphoma

Summary: the aim of the trial is to improve efficacy of nivolumab in patients with relapsed or refractory hl who recently progressed on anti-pd1 therapy. nivolumab is highly effective and well tolerated in rrhl, nevertheless cr-rates are low and a considerable proportion of patients suffers from progressive disease. localized rt induces an immunogenic effect which might work synergistically and facilitate augmented systemic (i.e. abscopal) responses in combination with nivolumab.


Eligibility criteria:
inclusion criteria: * progression of refractory or relapsed chl during treatment with an anti-pd1 agent * at least two distinct fdg-avid hl-lesions with at least 5 cm distance between them, and one of them considered eligible for irradiation with 20gy based on localization and prior rt exposure * age at registration ≥ 18 years exclusion criteria: * nodular-lymphocyte predominant hl (nlphl) or composite/greyzone lymphoma * lymphoma involving the central nervous system * naïve to treatment with anti-pd1 targeting antibodies
evaluation of the efficacy, safety, and tolerability of sarizotan in rett syndrome with respiratory symptoms

Conditions: Rett Syndrome

Summary: this study evaluates the safety, tolerability and efficacy of sarizotan in reducing respiratory abnormalities in rett syndrome in an initial double blind 24 week period followed by an open label treatment phase of up to 168 weeks (the latter for patients with no safety and tolerability issues).

this is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and efficacy of multiple doses of sarizotan in patients with rett syndrome with respiratory abnormalities. the study participants will be randomized to either sarizotan between 2 and 10 mg bid or placebo bid, based on age and weight criteria. all patients who have completed the final evaluations at week 24 (day 168) and have no safety or tolerability issues that would preclude continuing on the study medication and have been compliant with the trial requirements will have the option of continuing open-label treatment with sarizotan for up to 168 weeks.

Eligibility criteria:
inclusion criteria: * body weight ≥ 10 kg * age ≥ 4 years * diagnosis of rett syndrome based on consensus clinical criteria and patients with mecp2 duplications will not be eligible. * has at least 10 episodes of breathing dysrhythmia, defined by episodes ≥10 seconds of breath holding (apnea), per hour during cardiorespiratory monitoring * ability to take study medication provided either as capsules or combined with food/drink. * patient is cooperative, willing to complete all aspects of the study, and capable of doing so with assistance of a caregiver. exclusion criteria: * meets any of the diagnostic exclusion criteria for rett syndrome, typical (neul et al, 2010); * patient is participating in a clinical trial with another investigational drug * hypersensitivity to sarizotan or other 5-ht1a agonists; * current clinically significant (as determined by investigator) cardiovascular, respiratory (e.g. severe asthma), gastrointestinal, renal, hepatic, hematologic or other medical disorders, in addition to those directly related to the patient's rett syndrome; * qtcf interval on the ecg is greater than 450 msec. * surgery planned during the study (except for insertion of gastrostomy tube); * severe diabetes mellitus or fatty acid oxidation disorder. * ophthalmologic history including any of the following conditions: albino patients, family history of hereditary retinal disease, retinitis pigmentosa, any active retinopathy or severe diabetic retinopathy. * females who are pregnant, breastfeeding, or of childbearing potential and not using a hormonal contraceptive.