Kornimate/medical-research-clean huggingface dataset:
early detection of patients at risk of developing a post-traumatic stress disorder after a stay in intensive care unit

Conditions: Post Traumatic Stress Disorder

Summary: post-traumatic stress disorder (ptsd) is a psychiatric pathology noticed in the dsm-5, in troubles due to a traumatism or a stress factor and appearing at least 1 month after confrontation with trauma. this trouble can become chronic, and be the source of psychiatric and somatic comorbidities, which themselves have personal, professional and economic consequences at the level of the individual and society. some studies looked at the psychological effects induced by a stay in intensive care unit (icu) since few years. the emergence of ptsd in these patients has been described, with an incidence varying from 4% to 60%. the literature is contradictory about identified risk factors for ptsd. it's not possible to design a screening of these patients actually, only focused on the risk factors. it has been shown that the presence of acute stress trouble (presence of symptoms during the first month after the traumatism) was a risk factor for ptsd. early detection of acute stress disorder could be a way to screen risk of emergence of a post-intensive care ptsd. post-intensive care consultations have been done at 6 months, but not systematically. only few symptoms are looked for and a sizable part of this population were not being followed probably due to a non-diagnosed-ptsd. in case of the emergence of a post-intensive care ptsd, those patients will never be diagnosed and treated, favoring all complications linked to this trouble. associated with other factors, ies-r (impact event scale revisited) at the icu exit would permit an exhaustive screening of patients at risk for ptsd and could permit to propose them an adapted care and then limit the emergence of ptsd and its consequences.. in this study, the investigators will screen acute stress symptoms within 8 days following the icu's exit, using the ies-r, in order to evaluate his ability to predict the emergence of a ptsd at three months. ies-r is an auto-questionnaire, easy and fast with good psychometrics capacities for ptsd.


Eligibility criteria:
inclusion criteria: * patient over 18 years old leaving an intensive care unit after a stay of more than 72 hours, in one of the medical and surgical intensive care units of the e herriot hospital * patient having given his agreement to participate in this study exclusion criteria: * patient not understanding french language * confused patient (clinical assessment) * patient under protection measure or deprived from his rights
self titration with apidra to reach target study (start)

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: the primary objective of this study is to demonstrate non-inferiority of a patient-managed titration algorithm (including blood glucose monitoring) for the addition of a single dose of insulin glulisine at breakfast in canadian patients with inadequately controlled t2dm after optimization of basal insulin, compared with an hcp-managed titration algorithm. the primary endpoint for assessment of this objective is the percent of patients reaching a target hba1c \<=7.0% without severe hypoglycemia at the end of the study. secondary objective: secondary objectives of the study are to compare the effect of the two different insulin glulisine titration algorithms (patient-managed versus hcp-managed) on the following: * change in hba1c, fg, and 7-point glucose profile at week 24 and week 36 * satisfaction with treatment (dtsqc for patient and questionnaire for hcp) at week 36 * change in weight at week 24 and week 36 * incidence of hypoglycemia * insulin doses * resource utilization (rural/urban, blood glucose meter test strips, lancets, hcp visits, telephone calls, and hospitalizations) * adherence with the patient-managed monitoring algorithm


Eligibility criteria:
inclusion criteria: run-in phase: * t2dm * treated for at least 3 months with a basal insulin (insulin glargine, nph, detemir) +/- oral antidiabetic drugs (oads) with an hba1c \>7.0% or insulin naive (2-3 oads) with an hba1c \>=7.8% (historic hba1c result up to 3 months of screening is acceptable) randomized treatment phase: * completed run-in phase * hba1c \>7.0% and \>= 1 episode of confirmed nocturnal hypoglycemia (bg \ = 2 measurements of fg \ 7.0% and did not meet the randomization criteria will continue titrating insulin glargine and be followed until the end of study. exclusion criteria: * no food intake before lunch (noon) * unstable diet intake or significant changes to current diet regimen * nightshift worker * type 1 diabetes mellitus * subjects unwilling to inject insulin or perform self-monitoring blood glucose * pregnant, alcohol or drug abuse * active cancer or any other disease or condition which in the opinion of the investigator would make the subject unsuitable for participation in the study * any clinical significant laboratory findings that in the judgment of the investigator would preclude safe completion of the study * known allergies to study drugs the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
personalized active immunotherapy (vaccine therapy) and sargramostim given after standard of care treatment with rituximab and chemotherapy for initial treatment with lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: the treatment being investigated is a patient- and tumor-specific therapy known as a personalized active immunotherapy. personalized active immunotherapy is an attempt to use a person's own immune system to combat disease. sargramostim (a.k.a. gm-csf) is given together with the personalized active immunotherapy because it may increase the immune system's response and, therefore, aid in the effect of the personalized active immunotherapy. this approach has previously been studied in patients with follicular non-hodgkin's lymphoma and other b-cell malignancies. encouraging efficacy results and a favorable safety profile have been seen to date in these studies.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. previously untreated follicular nhl 3. stage iii or iv disease requiring treatment 4. able to receive rituximab and chemotherapy (rituximab with cyclophosphamide, vincristine, and prednisone either with or without doxorubicin) 5. able to provide tumor sample adequate for id-klh manufacture 6. ≥ 18 years of age 7. at least one bi-dimensionally measurable lesion ≥ 2 cm by ct scan
comparing telehealth-delivered cbt-i to web-based cbt-i to enhance sleep, reduce fatigue, and promote neuroprotection

Conditions: Multiple Sclerosis; Insomnia

Summary: the objective of this rct is to assess the efficacy of one-on-one telehealth cbt-i (tcbt-i) compared to web-based cbt-i (wcbt-i) and treatment as usual (tau) to improve sleep outcomes (aim 1), fatigue and quality of life (aim 2), and promote neuroprotection (exploratory aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (exploratory aim 4). reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.


Eligibility criteria:
inclusion criteria: * 18-65 years old * diagnosis of relapsing-remitting or secondary progressive ms based on established guidelines21 and verified by their neurologist * mild-to-moderately severe disability (≤ 6 on patient determined disability steps (pdds) scale) * report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the dsm-5 * ≥10 on insomnia severity index * english speaking * ≥31 on telephone interview of cognitive status * has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study * report having access to internet service or a data plan and access to a computer, tablet, or smart phone exclusion criteria: * known untreated sleep disorder (such as sleep apnea or restless legs syndrome) * \>3 on stop bang indicating increased risk of sleep apnea * restless legs syndrome as determined by rls-diagnosis index * circadian rhythm sleep-wake disorder as determined by the sleep disorders-revised * parasomnia as determined by the sleep disorders-revised * if taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking \< 3 months or dose has changed in past 3 months * score of ≥20 on the patient health questionnaire (phq-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the phq-9) * score of ≥15 on the generalized anxiety disorder (gad-7) indicating severe anxiety * current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by dsm-5 criteria * history of other nervous system disorder such as stroke or parkinson's disease * currently pregnant or intending to become pregnant in the next 6 months * severe mental illness such as schizophrenia or bipolar disorder * severe neurological or sensory impairments that would interfere significantly with testing * relapse and/or corticosteroid use in the past 8 weeks * history of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am * currently receiving a behavioral sleep health intervention

Keywords: cognitive behavioral therapy for insomnia cbt-i
low level laser therapy in muscle fatigue and muscle recovery

Conditions: Muscle; Fatigue, Heart; Skeletal Muscle Recovery

Summary: muscle fatigue and muscle recovery after exercise are recent areas of research involving low level laser therapy (lllt) and many factors remain unknown, such as optimal doses, power and application parameters, mechanisms of action, effects on long-term exercise and the long-term effects on skeletal muscle recovery. the present research project aims to assess the effects of long-term recovery of lllt in skeletal muscle after exercise and identify the optimal dose application of lllt. after defining the best dose of application, we recruited two groups which will be irradiated with different power, 100mw and 400mw in order to seek the optimal parameter of low level laser therapy in performance. the investigators believed that the low level laser therapy can delay the physiological process of muscle fatigue, reduce injury or skeletal muscle microdamage arising from physical effort and accelerate muscle recovery after exercise.

to achieve the proposed objectives it was performed a randomized, double-blinded, placebo-controlled trial, with voluntary participation of high-level soccer athletes. participants received an application of low level laser prior to execution of a strenuous exercise. it was used a laser with a cluster of 5 diodes (810 nm, 200 mw each diode) with different doses (placebo, 2j, 6j, 10j) and power of 200mw. in a second step, with the optimal dose already defined, this was used to be applied with different powers in two experimental groups, 100mw and 400mw. the investigators analysed parameters related to volunteers exercise performance (torque peak / maximum voluntary contraction), delayed onset muscle soreness, and biochemical markers of muscle damage (ck and ldh), inflammation (interleukin 1 and 6, alpha tumoral necrosis factor) and oxidative stress (tbars, cat, sod and carbonylated proteins). the analysis was performed before exercise protocols, after 1 minute, and 1, 24, 48, 72 and 96 hours after the end of exercise protocol in both parts of the study.

Eligibility criteria:
inclusion criteria: * professional soccer players aged between 18 and 35 years old; * not presenting historical musculoskeletal injury in regions of the hip and knee in the 2 months preceding the study; * not making use of pharmacological agents and/or nutritional supplements; * participating with minimum frequency of 80% of the training team exclusion criteria: * athletes who experience musculoskeletal injury during the study; * athletes who for whatever reason have their training routine changed with respect to the rest of the team during the course of study.

Keywords: lllt muscle fatigue and recovery phototherapy parameter
adjuvant docetaxel and estramustine phosphate for high risk localized prostate cancer

Conditions: Prostate Cancer

Summary: this trial will evaluate the feasibility, toxicity, and efficacy of docetaxel/estramustine, as in the adjuvant therapy of patients with high-risk prostate cancer after definitive local therapy.

upon determination of eligibility, patients will receive: docetaxel + estramustine

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * histologically confirmed adenocarcinoma of the prostate * clinically or surgically staged localized disease, stage i-iii. * prior surgical resection or radiation therapy with curative intent * no clinical evidence of residual disease * gleason's combined score \> 7. * age \> 18 years. * no prior chemotherapy for prostate cancer. * no previous androgen deprivation therapy for prostate cancer * able to perform activities of daily living with minimal assistance * adequate bone marrow, liver and kidney function * voluntarily provide written informed consent. exclusion criteria: you cannot participate in this study if any of the following apply to you: * history of prior malignancy in the past five years * history of significant heart disease within the previous 6 months * cerebral vascular accident (cva) or stroke within the previous 6 months. * moderate or severe peripheral neuropathy * previous therapy with other injectable radioisotopes. please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
characterizing follicles from auto-transplanted ovarian tissue

Conditions: Infertility, Female

Summary: the aim of the project is to characterize the hormonal conditions in egg follicles in women who, prior to fertility treatment, have had autotransplanted frozen ovarian tissue for the purpose of fertility preservation.


Eligibility criteria:
inclusion criteria: * women aged 18 years or older * has had frozen and later autotransplanted ovarian tissue for fertility preservation purposes * included in fertility treatment with eff retrieval at the fertility clinic regional hospital skive * is willing and able to give informed consent exclusion criteria: - patients undergoing fertility treatment but have not received autotransplanted ovarian tissue for fertility preservation purposes

Keywords: infertility
styrian vitamin d hypertension trial

Conditions: Arterial Hypertension; Vitamin D Deficiency

Summary: in this randomized, double-blind, placebo-controlled trial we plan to enrol 200 vitamin d deficient hypertensive patients. our main objective is to evaluate whether vitamin d3 supplementation with 2,800 iu daily for 8 weeks has an effect on 24-hour systolic ambulatory blood pressure (abp) compared to placebo. in addition, we also aim to evaluate whether vitamin d3 supplementation alters 24-hour diastolic abp, pulse wave velocity, n-terminal-pro-brain natriuretic peptide (nt-pro-bnp), corrected qt interval (bazett formula), renin, aldosterone, 24-hour urinary albumin excretion, homa-ir (homeostatic model assessment: insulin resistance), triglycerides and hdl-cholesterol.


Eligibility criteria:
inclusion criteria: * 25-hydroxyvitamin d levels below 30 ng/ml (75 nmol/l) * arterial hypertension defined according to recent guidelines as an average office blood pressure on at least two occasions of systolic ≥ 140 and/or diastolic ≥ 90 mmhg or a mean 24-hour abp of systolic ≥ 125 and/or diastolic ≥ 80, or a home blood pressure of systolic ≥ 130 and/or diastolic ≥ 85 or ongoing antihypertensive treatment which was initiated due to arterial hypertension * age of ≥ 18 years * written informed consent. exclusion criteria: * hypercalcemia defined a serum calcium \>2.65 mmol/l * pregnancy or lactating women * drug intake as part of another clinical study * acute coronary syndrome or cerebrovascular events in the previous 2 weeks * glomerular filtration rate (gfr) according to the mdrd formula \< 15 ml/min/1.73m² * systolic 24-hour abp \> 160 mm hg or \< 120 mm hg * diastolic 24-hour abp \> 100 mm hg * change of antihypertensive treatment (drugs and/or lifestyle) in the previous 4 weeks or planned changes of antihypertensive treatment during the study * any disease with an estimated life expectancy below 1 year * any clinically significant acute disease requiring drug treatment * chemotherapy or radiation therapy during the study * regular intake of more than 880 international units (iu) vitamin d per day in the last four weeks before study entry or during the study
study evaluating the pharmacokinetics and safety of epratuzumab in japanese systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: the primary objective of the study is to evaluate the safety, tolerability and pharmacokinetics (pk) of epratuzumab in japanese subjects with moderate to severe general sle as add on to standard of care treatment during the trial.


Eligibility criteria:
inclusion criteria: * positive anti-nuclear antibody (ana) at screening (visit 1) * current clinical diagnosis of systemic lupus erythematosus (sle) by american college of rheumatology (acr) criteria * active moderate to severe sle activity as demonstrated by british isles lupus assessment group index (bilag) * active moderate to severe sle disease as demonstrated by systemic lupus erythematosus disease activity index (sledai) total score on stable sle treatment exclusion criteria: * subjects who are breastfeeding, pregnant, or plan to become pregnant * subjects with active, severe sle disease activity which involves the renal system and active, severe, neuropsychiatric sle, defined as any neuropsychiatric element scoring bilag level a * serious infections

Keywords: lupus monoclonal antibody b-cell immunotherapy epratuzumab
reassure-nirs registry

Conditions: Lipid-Rich Atherosclerosis of Coronary Artery

Summary: ressure-nirs registry is designed to investigate clinical and pathophysiological characteristics of nirs-derived lipid-rich plaque in patients with coronary artery disease. this is an on-going multi-center prospective registry in japan.

nirs imaging is an invasive intravascular imaging modality to quantitatively visualize lipid-rich atheroma in vivo. while nirs-derived lipid-rich plaque has been shown to associate with cardiovascular events, there is limited clinical data about the association of this high-risk plaque with risk factors, medication use, prognosis and response of pci. ressure-nirs registry is an on-going multi-center prospective registry in japan, which enroll subjects with coronary artery disease who received nirs imaging to evaluate coronary atherosclerosis. the primary outcome is maximum 4-mm lipid core burden index at coronary lesions measured by nirs imaging. secondary major outcomes include entire lipid core burden index, plaque volume, plaque attenuation and echo-lucent area. the anticipated number of study subjects is 2000 cases.

Eligibility criteria:
inclusion criteria: patients with coronary artery disease clinical indication for coronary angiography and/or percutaneous coronary intervention visualization of coronary lesions with nirs exclusion criteria: poor quality of nirs images

Keywords: near-infrared spectroscopy lipid-rich plaque coronary artery disease intravascular imaging
nt-probnp as a tool for the detection of acute pulmonary artery embolism (ape)

Conditions: Pulmonary Embolism; Pulmonary Embolism Without Mention of Acute Cor Pulmonale

Summary: in patients with suspected ape (acute pulmonary embolism) referred to the intensive care unit (icu)after major surgery, serum nt-probnp (n-terminal probnp), troponin-i and d-dimers were measured according to the standard hospital protocol. to definitively confirm or exclude ape, all patients underwent an angiographic ct-scan of the thorax.

in patients with suspected ape referred to the intensive care unit after major surgery, serum nt-probnp, troponin-i and d-dimers were measured according to the standard hospital protocol. blood samples were obtained within one hour after the onset of clinical symptoms. definitive confirmation or exclusion of ape was performed with an angiographic ct-scan of the thorax.

Eligibility criteria:
inclusion criteria: all patients referred to the icu with suspected ape exclusion criteria: none

Keywords: misadventures to patients during surgical and medical care pulmonary embolism without acute cor pulmonale pulmonary embolism without mention of acute cor pulmonale
safety of the herpes zoster subunit vaccine in lupus

Conditions: Systemic Lupus Erythematosus

Summary: this randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the herpes zoster sunbit (hz/su) vaccine in sle patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. the investigators hypothesize that hz/su administration will be non-inferior to placebo with respect to the risk of moderate or severe sle flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment. in addition, the investigators hypothesize that immunogenicity of the vaccine in sle patients will be at least 50% of levels observed in healthy subjects from prior large clinical trials.


Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures 2. female or male ≥18 years of age at the time of signing the informed consent 3. meet the 2019 eular/acr classification criteria for sle 4. female subjects must use 1 effective method of avoiding pregnancy, from the time they sign consent until end of the study period unless the subject is surgically sterile (e.g., bilateral oophorectomy or complete hysterectomy), has a sterile male partner, is at least 1 year postmenopausal, or practices sustained abstinence consistent with the subject's customary lifestyle. postmenopausal is defined as at least 1 year since last menses and the subject has an elevated follicle-stimulating hormone (fsh) level greater than the threshold laboratory value of post-menopausal women at screening. exclusion criteria: 1. prior administration of the herpes zoster subunit vaccine (shingrix) or the varicella-zoster virus vaccine live (zostavax) 2. clinical hz infection within 12 months prior to screening or during screening 3. hybrid sledai \>12 at screening visit 4. presence of a mild, moderate, or severe flare per the rsfi at time of screenin 5. increase in clinical sledai parameters at time of enrollment relative to screening visit 6. any vaccine, including the final/booster dose of any sars-cov-2 vaccine, within six weeks enrollment 7. receipt of rituximab or cyclophosphamide within nine months of enrollment 8. participation in an interventional clinical trial of sle or other therapeutics within six months of enrollment 9. moderate to severe infectious febrile illness or use of systemic antibiotics (antibacterial, antiviral, antifungal, or antiparasitic agent) within 4 weeks of enrollment 10. are pregnant, nursing, or planning a pregnancy while enrolled in the study 11. known primary or secondary immunodeficiency (malignancy, hiv, common variable immune deficiency) or medications used during cancer chemotherapy

Keywords: herpes zoster subunit vaccine