Kornimate/medical-research-clean huggingface dataset:
diabetesflex - patient involvement and patient-reported outcome measures in type 1 diabetes

Conditions: Type1 Diabetes Mellitus

Summary: the aim of this study is to investigate the effect of the use of diabetesflex in diabetes care compared to standard care in relation to patient involvement and relevance for specific group of persons with t1dm. the investigators hypothesize that the use of diabetesflex will lead to a higher degree of patient in-volvement, improved glycaemic control and a decrease in total number of consultations compared to standard care. furthermore, the investigators aim to identify if a specific sub-population within the t1dm population will benefit significantly from the intervention.

diabetes mellitus (dm) is a chronic condition, and provision of individual and effective diabetes care is a major challenge. the is a lack of evidence on the optimal frequency of attending outpatient clinics for persons with t1dm. the use of patient-reported outcome (pro) measures in diabetes care area are limited and none existing in a danish context. this includes studies, which combine pro measure with diabetes management, patient involvement and self-management. the study will generate knowledge and directions for ways to reframe and to optimize the future management of diabetes care.

Eligibility criteria:
inclusion criteria: age over 18 years have had t1dm for more than 1 years be able to use the danish-language general website on healthcare www.sundhed.dk be mentally well functioning understand and read danish access to internet

Keywords: self-management patient activeted measure patient-reported outcome type 1 diabetes mellitus non-inferiority study
expanded access of imvotamab (igm-2323) in patients with r/r nhl

Conditions: Relapsed/Refractory Non-Hodgkin Lymphomas

Summary: expanded access of imvotamab (igm-2323) in patients with relapsed/refractory non-hodgkin lymphomas from igm-2323-001 clinical trial.


Eligibility criteria:
inclusion criteria: * demonstrated clinical benefit (sd, pr, or cr) on clinical trial protocol igm-2323-001 * there is no adequate alternative treatment available for the patient. * provided consent to continue treatment on expanded access program. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to the first dose. * for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive measures. * for men: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive. exclusion criteria: * history of severe allergic or anaphylactic reactions to mab (or recombinant antibody related fusion proteins). * any medical condition or clinical laboratory abnormality likely to interfere with assessment of safety or efficacy of investigational product, or indicating patient would unlikely have potential benefit. * pregnant, breastfeeding, or intending to become pregnant during the program or within 2 months after the final dose of imvotamab. * in the treating physician's judgement, the patient is unlikely to complete all procedures, including follow-up visits, or comply with the requirements for participation. * vaccination with live virus vaccines during treatment and for 3 months following the last cycle of imvotamab.
creation of a biotheque of patients of seine-maritime with meningococcal infection

Conditions: Meningococcal Infections

Summary: the main objective of this study is to constitute a biotheque of patients with meningococcal disease to enable results to be interpreted and genetic factors to be determined


Eligibility criteria:
inclusion criteria: * subjects of seine-maritime with a meningococcal disease from the year of 2000 * parental authority assent if necessary exclusion criteria: * no parental authority assent * child under supervision

Keywords: meningococcal infections biotheque genetic markers
safety and feasibility study of autologous stromal vascular fraction (svf) cells for treatment of osteoarthritis

Conditions: Osteoarthritis

Summary: autologous stromal vascular fraction (svf) injected into joints of 20 patients with grade 2, 3, or 4 radiographic oa severity will be safe and feasible as assessed by lack of treatment associated adverse events. improvements in joint function as assessed by western ontario and mcmaster universities osteoarthritis index (womac) are anticipated.

the proposed study is a single center, unblinded, non randomized, phase i/ii trial in which the patients will be treated with a single dose of autologous stromal vascular cells (svf) isolated from 500 ml of adipose tissue extracted from the infraumbilical area. the cellular product will be administered via intra-articular injection into patients with moderate to severe osteoarthritis (oa). administration will be performed by injection into the synovial space. the dosing regimen will consist of two intraarticular injection of autologous svf into the index knee. total injection volume will be about 30 ml in two 15 ml aliquots via a 23 gauge needle inserted 1.5 cm. deep into the intraauricular space of the knee. the total number of svf to be injected is 1.0 x 10(7) to 5 x 10(7). the purpose of this study will be to define the safety and efficacy of svf therapy in improving joint function and the quality of life in patients with oa of the knee. we plan to enroll twenty subjects for treatment for an adequate sample size for safety analysis with signals of efficacy. the primary safety outcome will be tabulation of adverse events related to treatment. efficacy will be quantified at 3, 6 and 12 months by the total western ontario and mcmaster universities osteoarthritis index (womac).

Eligibility criteria:
inclusion criteria: age \>18 years and ability to understand the planned treatment. idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified kellgren-lawrence classification ability and willingness to undergo liposuction exclusion criteria: pregnant women or cognitively impaired adults. presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging. inflammatory or postinfectious arthritis. more than 5 degrees of varus or valgus deformity. kellgren lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age. intraarticular corticosteroid injection within the previous 3 months. a major neurologic deficit. serious medical illness with a life expectancy of less than 1 year. prior admission for substance abuse body mass index (bmi) of 40 kg/m2 or greater patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent in the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy -

Keywords: autologous adipose stem cells stromal vascular fraction osteoarthritis
skeletal muscle as a mediator of exercise induced effects on metabolism & cognitive function: role for myokines & mirnas

Conditions: Mild Cognitive Impairment; Alzheimer Disease; Parkinson Disease; Healthy Volunteers

Summary: the purpose of this study is to determine specific changes in muscle secretory profile (myokines, mirna) in association with neurodegenerative disease progression and metabolic dysfunction. next the investigators would like to determine the shift in the muscle secretory activity induced by regular exercise intervention, which the investigators think could be translated into the beneficial changes in clinical phenotypes, determined by neuroimaging, cognitive function tests and metabolic phenotyping.

standard operating procedures for patient recruitment, data collection, data management, data analysis routinely used in university hospital bratislava and in institute of experimental endocrinology slovak academy of sciences will be employed. statistical analysis will be employed to address the primary and secondary objectives, as specified in the study protocol.

Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. diagnosed with parkinson disease 3. diagnosed with mild cognitive impairment (mci) or alzheimer disease (ad) exclusion criteria: 1. serious systemic cardiovascular, hepatic, renal disease, cancer. 2. lack of compliance.

Keywords: micrornas exercise skeletal muscle metabolism
effect of burn size on cytomegalovirus reactivation and correlates of t cell immune function in burned patients

Conditions: Burns; Cytomegalovirus

Summary: the purpose of this study is to evaluate the effect of burn injury on the human immune system with a focus on cytomegalovirus (cmv) reactivation and the immunologic correlates of latent viral reactivation. subjects will be patients admitted to the north carolina jaycee burn center with burn injury. blood samples will be collected over time and will be evaluated for cmv reactivation and immune cell phenotype.

the purpose of this research study is to learn about infections and the immune system in people who suffer from burn injuries. the immune system changes after burn injury and infection is one of the most common complications. cytomegalovirus (cmv) is a virus that most people are exposed to early in life; once you are exposed it lays inactive in your body forever. when the immune system is suppressed, this virus can reactivate. we would like to measure how this virus makes copies of itself in the blood stream in people with a burn injury and to look at cell markers of the immune system. this study involves baseline and weekly blood draws for approximately 8 weeks. if blood tests show cmv infection, further monitoring of blood work may be needed after eight weeks.

Eligibility criteria:
inclusion criteria: * burn injury, * positive cmv igg level confirmative of previous cmv infection and latency. exclusion criteria: * immunocompromising conditions including hiv/aids, * end-stage renal disease, * end-stage liver disease, * pregnancy, * rheumatologic or collagen-vascular disease requiring chronic use of steroids, * chronic use of immunosuppressive agents, * recent chemotherapy, and * history of solid organ or allogeneic stem cell transplant.
safety and efficacy of botulinum toxin type a topical gel for primary axillary hyperhidrosis

Conditions: Hyperhidrosis

Summary: this is a safety and efficacy study of botulinum toxin type a in subjects with primary axillary hyperhidrosis.


Eligibility criteria:
inclusion criteria: * primary axillary hyperhidrosis * female or male, 18 years of age or older in good general health * excessive sweating interferes with daily life activities and scores 3 or 4 on the hdss at screening and baseline * axillary sweat production of at least 50 mg/5 min measured gravimetrically exclusion criteria: * any neurological condition, that may place the subject at increased risk with exposure to botulinum toxin type a such as amyotrophic lateral sclerosis and motor neuropathy, lambert-eaton syndrome, and myasthenia gravis * muscle weakness or paralysis, particularly in the upper extremities * active skin disease or irritation or disrupted barrier at the treatment area * undergone any procedures which may affect the axillary areas * treatment with botulinum toxin type a in the axilla in the last 9 months or anywhere in the body in the last 6 months * any prior axillary use of an anti-hyperhidrosis medical device * if menopausal had symptoms of menopause such as sweating or flushing within the last year
central blood pressure over 24 hours (abpm) and left ventricular mass

Conditions: Suspected Arterial Hypertension

Summary: the investigators aim to investigate whether central systolic blood pressure, as measured during regular 24 hour ambulatory blood pressure monitoring (abpm), is a better predictor of left ventricular mass than peripheral systolic blood pressure during abpm.

it seems obvious that central blood pressures are pathophysiologically more relevant than peripheral blood pressures for the pathogenesis of cardiovascular disease: it is central systolic pressure (csbp) against the heart ejects (afterload), and it is central pulse pressure (cpp) that distends the large elastic arteries. indeed, csbp and cpp have been associated more closely with left ventricular hypertrophy and carotid atherosclerosis as markers of hypertensive end-organ damage than brachial pressures in various populations. however, in these studies office blood pressure measurements have been used. as abpm measurements per se show a closer association with hypertensive end-organ damage than office measurements, and as the investigators have recently developed and validated a novel algorithm (arcsolver) to calculate central blood pressures from peripheral waveforms, the investigators speculate that csbp measured during abpm may be the best predictor of left ventricular mass.

Eligibility criteria:
inclusion criteria: \> 18 years of age, * no intake of antihypertensive medications * should have an indication for abpm (suspected arterial hypertension) exclusion criteria: * no written informed consent * left ventricular hypertrophy due to other reasons than hypertension (hypertrophic cardiomyopathy, infiltrative cardiomyopathy, valvular heart disease, congenital heart disease) * inability to provide adequate echocardiographic readings * segmental contraction abnormalities of the left ventricle * contraindications for abpm (lymphedema both arms) * other rhythm than stable sinus rhythm * unstable clinical condition, including recent severe infections

Keywords: arterial hypertension
study of efficacy and safety of two secukinumab dose regimens in subjects with moderate to severe hidradenitis suppurativa (hs)

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study was to demonstrate superiority of secukinumab at week 16, based on hidradenitis suppurativa clinical response (hiscr) rates versus placebo, along with the maintenance of efficacy of secukinumab at week 52 in subjects with moderate to severe hs. moreover, this study assessed the safety and tolerability of secukinumab.

this was a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in patients with moderate to severe hs. the study consisted of: screening (up to 4 weeks) treatment period 1 (16 weeks, active drug or placebo) and treatment period 2 (up to 1 year all patients on active drug); there was an optional extension study (nct04179175). adult males and females with moderate to severe hs were included, with a diagnosis of hs greater than 1 year prior to baseline. dosing was once every 2 weeks, or once every 4 weeks via pre-filled syringe; periodic home-dosing is included. in treatment period 1, participants were randomized to secukinumab q2w, secukinumab q4w, placebo q2w or placebo q4w in 1:1:0.5:0.5 ratio. in treatment period 2, at the week 16 visit participants initially randomized to placebo were switched to one of the two active dose regimens (secukinumab q2w or q4w), while subjects randomized to secukinumab during treatment period 1 continued on the same dose.

Eligibility criteria:
inclusion criteria: * -written informed consent must be obtained before any assessment is performed. * male and female patients ≥ 18 years of age. * diagnosis of hs ≥ 1 year prior to baseline. * patients with moderate to severe hs defined as: * a total of at least 5 inflammatory lesions, i.e. abscesses and/or inflammatory nodules and * inflammatory lesions should affect at least 2 distinct anatomic areas * patients agree to daily use of topical over-the-counter antiseptics on the areas affected by hs lesions while on study treatment. exclusion criteria: * total fistulae count ≥ 20 at baseline. * any other active skin disease or condition that may interfere with assessment of hs. * active ongoing inflammatory diseases other than hs that require treatment with prohibited medications. * use or planned use of prohibited treatment. washout periods detailed in the protocol have to be adhered to. * history of hypersensitivity to any of the study drug constituents. * history of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). * pregnant or lactating women.

Keywords: acne inversa hidradenitis suppurativa maladie de verneuil inflammatory disease ain457 ain457m secukinumab hs lumps skin lesions
acetaminophen for fetal tachycardia: a randomized pilot trial

Conditions: Fever; Heart Rate, Fetal (FHR)

Summary: the most common cause of fetal tachycardia is maternal fever. fetal tachycardia often precedes the maternal fever, and fetal tachycardia confounds the interpretation of electronic fetal monitoring (efm), increasing the rate of cesarean delivery for non-reassuring fetal status (nrfs). our hypothesis is that treatment of fetal tachycardia with acetaminophen will significantly lower maternal body temperature and significantly lower baseline fetal heart rate (fhr). the importance is that interpretation of efm will improve, thus allowing for a decrease in cesarean delivery for nrfs.

this trial is a randomized, non-placebo controlled, assessment of whether acetaminophen can lower maternal temperature and baseline fetal heart rate in laboring patients with fetal tachycardia. term singleton cephalic pregnancies in active phase labor (spontaneous or induced) with fetal tachycardia will be recruited. patient will be excluded for: * exclusion criteria (prior to randomization): * acetaminophen allergy * clinical chorioamnionitis * maternal fever * non-reassuring fetal status (nrfs), which is the designation for fetal heart rate abnormalities requiring cesarean delivery * previous cesarean delivery * multifetal gestation * breech presentation * known fetal anomaly * known contraindication to vaginal delivery primary outcome measures are: 1. maternal body temperature (oral) 90 minutes after treatment 2. baseline fhr secondary outcome measures are: 1. temperature difference before and after treatment 2. rate of cesarean delivery 3. rate of determination of nrfs 4. rate of subsequent development of maternal fever 5. rate of diagnosis of clinical chorioamnionitis 6. rate of neonatal sepsis power calculation internal data collection at our institution of 53 patients showed a mean decrease in temperature of patients in labor with fever receiving acetaminophen is 0.3 degrees c measured an average (mean) of 90 minutes after administration of acetaminophen. mean oral temperature before acetaminophen was 38.32, sd 0.33. mean oral temperature after acetaminophen was 38.03, sd 0.85. sample size calculation shows that 27 patients are needed in each group to show significant difference using alpha 5% and beta 50%.

Eligibility criteria:
inclusion criteria: * term pregnancy * singleton pregnancy * pregnancy with cephalic presentation * pregnancy in active phase labor * fetal tachycardia exclusion criteria: * acetaminophen allergy * clinical chorioamnionitis * maternal fever * non-reassuring fetal status or fetal heart rate abnormalities requiring cesarean delivery * previous cesarean delivery * multifetal gestation * breech presentation * known fetal anomaly * known contraindication to vaginal delivery

Keywords: fetal tachycardia fever in labor acetaminophen non reassuring fetal status
prevention of acute kidney injury by erythropoietin in thoracic aorta surgery with hypothermic cardiac arrest

Conditions: Dissection of Thoracic Aorta

Summary: during thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and reperfusion (ir) periods, respectively. aortic ischemia results in an ischemic insult to the lower extremities and successive reperfusion results in injury to remote organs, including kidneys. so, there has been considerable interest in the development of therapeutic strategies aimed at attenuating ir injury. one such group of agents that are attracting interest due to their potential protective effects on vascular endothelium is the erythropoietin. however, the effect of erythropoietin on renal injury induced by aortic ir in humane has not been fully clarified. therefore, the purpose of this study is to determine whether the prophylactic administration of erythropoietin reduce the incidence of acute kidney injury (aki) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. the investigators administrate the erythropoietin single bolus (500 iu/kg intravenously) 30 min before the commencement of ischemia. the differences between the control and study groups are observed by clinical indicators such as serum creatinine, tnf-α, ngal.


Eligibility criteria:
inclusion criteria: 1. adults above age of 20 2. undergoing thoracic aorta surgery with hypothermic cardiac arrest exclusion criteria: 1. pregnancy or lactation 2. cerebrovascular thrombosis 3. past history of pulmonary embolism or thrombosis 3. past history of thoracic aortic surgery 4. malignancy 5. preoperative acute kidney injury 5. chronic renal replacement therapy 6. allergy or hypersensitivity to erythropoetin 7. history of erythropoetin treatment 8. death during or one day after surgery 9. no consent 10. reoperation within seven days of the first surgery