Kornimate/medical-research-clean huggingface dataset:
ag-858 in patients who are cytogenetically positive after treatment with gleevec™

Conditions: Leukemia, Myeloid, Chronic

Summary: this is a phase ii, exploratory, open-label study of the investigational product ag-858, in patients who are cytogenetically positive after treatment with gleevec. the trial will consist of three independent phase ii evaluations of patient groups according to their cytogenetic status as defined in the eligibility criteria (eligibility criteria 4a, 4b, and 4c).

the goals of this study are to determine the following: * to estimate the proportion of patients with a complete cytogenetic response (ccr) within each patient group * to estimate the proportion of patients with a substantial molecular response (smr) within each patient group * to evaluate the frequency and severity of adverse events. * to assess the feasibility of ag-858 production.

Eligibility criteria:
inclusion criteria: * must be philadelphia chromosome positive chronic myelogenous leukemia in first chronic phase * must have a complete hematologic response * must have received gleevec™, ifn-α, cytarabine, busulfan, hydroxyurea, homoharringtonine (hht) or any combination thereof as long as the combination has been discontinued and the dosing of gleevec™ has been stable for 6 months or greater * must have one of the following cytogenetic statuses: (a) less than a ccr after receiving gleevec™ for at least one year at a minimum dose of 400 mg/day. a stable dose of gleevec™ must have been maintained for the last six months prior to eligibility testing or (b) stable cytogenetic status without ccr (no cytogenic response or progression) in three consecutive determinations over six months while on a stable dose of gleevec™ (at a minimum of 400mg/day) for at least 6 months or (c) cytogenetic progression while on a stable dose of gleevec™ (at a minimum dose of 400mg/day)for at least 2 consecutive evaluations at least one month apart * ecog performance score of 0 or 1 * must be at least 18 years old * not pregnant or breastfeeding and agree to use contraception during the course of the study * no prior allogeneic bone marrow transplant or be candidates for curative bmt * no immunodeficiency or other serious illness * no current use of immunosuppressive medications * no other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin

Keywords: granulocytic leukemia, chronic leukemia, granulocytic, chronic leukemia, myelocytic, chronic leukemia, myelogenous, chronic myelocytic leukemia, chronic myelogenous leukemia, chronic myeloid leukemia, chronic
the role of a natural product, containing nanovesicles from citrus limon (l.) juice, on different cv risk factors

Conditions: Metabolic Syndrome; Healthy Volunteers

Summary: clinical trial about beneficial effects of natural supplement in a spray-dried formulation, citraves™, obtained from citrus limon (l.) juice on general body health.

this is one randomized, double-blind, placebo-controlled study. the aim of the present study is to investigate the role of a natural product, citraves™ on several cardiovascular risk factors. the research hypothesis is to evaluate whether this natural supplement containing nanovesicles delivered from citrus limon (l.) juice (navhetec s.r.l., palermo, italy) may improve different cardio-metabolic parameters in subjects with the metabolic syndrome. all subjects will be evaluated at baseline, after 1 month and after 3 and 6 months of supplementation with natural product or placebo.

Eligibility criteria:
inclusion criteria: * men and women \> 18 years old; * body mass index (bmi) \> 25 kg/m²; * subjects who are able to swallow; * subjects who are willing to participate in the study and therefore, to sign informed consent prior to any study procedure; * the inclusion criteria for patients with mets was also the diagnosis of mets, as defined by international consensus \[alberti kg, et al. circulation. 2009; 120:1640-5\]. exclusion criteria: * pregnancy or the willingness to become pregnant; * severe renal or hepatic impairment; * known severe infections (such as hiv, hbv, hcv) * any neoplasms; * the exclusion criteria for healthy volunteers were also diagnosis of any one of the following diseases: hypertension, diabetes mellitus, dyslipidaemia or metabolic diseases.

Keywords: cardiovascular risk extracellular vesicles metabolic parameters nutraceuticals citrus limon (l.)
breathing techniques and meditation for health care workers during covid-19 pandemic

Conditions: COVID-19 Infection

Summary: this phase i trial investigates breathing techniques and meditation for health care workers during covid-19 pandemic. breathing techniques and medication may help manage stress and improve lung health. the goal of this trial is to learn if breathing techniques and meditation may help to reduce stress and improve lung health in health care workers during the covid-19 pandemic.

primary objective: i. to demonstrate the feasibility of a short pranayama or breathing techniques and meditation during covid-19 pandemic. secondary objectives: i. to determine the adherence to the practice assessed as at least 50% of participants implement the intervention for 3 or more times in a week by the end of week 1/day 7 (+ 3 days). ii. to determine the change in resilience, perceived stress and psychological impact from day 0 today 28 as measured by the brief resilient coping scale (brcs), perceived stress scale (pss4), and covid-19 stress among health care workers questionnaire. iii. to determine the changes in breath holding time measured weekly for 4 weeks. iv. to determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice. outline: patients view an instructional video on breathing techniques and meditation. patients then perform breathing techniques over 3 minutes and meditation over 2 minutes twice daily (bid) for 28 days.

Eligibility criteria:
inclusion criteria: * participants must be able to read and understand english * must be employed at md anderson cancer center exclusion criteria: * epilepsy * brain tumor * brain aneurysm * pregnant or trying to get pregnant * brain bleeding in the past 1 year * recent abdominal surgery and not cleared to exercise
the effect of a preoperative single-dose methylprednisolone on the postoperative rehabilitation after abdominal hysterectomy

Conditions: Hysterectomy; Methylprednisolone; Postoperative Pain

Summary: the purpose of this study is to evaluate the effect of 125 mg methylprednisolone, given intravenously 60-90 minutes before abdominal surgery,on the postoperative rehabilitation after abdominal hysterectomy.sodium chloride is the placebo. the following parameters are registered: 1. pain 3, 6 and 24 hours postoperatively and 2-7 days after surgery. 2. the postoperative use of additional analgesics. 3. inflammatory parameters before and after surgery. 4. time until mobilization. 5. time until discharge.


Eligibility criteria:
inclusion criteria: * patients having an abdominal hysterectomy on a benign indication. * patients who speak and understand danish. * patients who can give informed consent. exclusion criteria: * diabetics * regular use of glucocorticoids, opioids or tranquilizers * regular treatment with immunosuppressives * alcohol or drug abuse * morphine intolerance * age under 18 * chronic pain disease eg fibromyalgia, rheumatoid arthritis * malign indication for hysterectomy * bmi over 35 * decreased kidney function * asa iii or iv

Keywords: abdominal hysterectomy glucocorticoids rehabilitation postoperative pain analgetics
new approaches for the identification and characterization of functional markers of the risk of extension of breast cancer without lymph node involvement

Conditions: Breast Cancer

Summary: 1. identify the tissue proteins associated with early breast cancer invasion phases without lymph node involvement . 2. consider their role in the invasion and the risk of tumor spread .


Eligibility criteria:
inclusion criteria: * breast cancer * ccis * invasive tumors * breast cancer tissues available in the biobank exclusion criteria: * non availability of cancer tissue specimen

Keywords: proteomics
observational study on the prevalence of urinary incontinence in federates athletes.

Conditions: Urinary Incontinence

Summary: to study the prevalence of urinary incontinence (ui) in female athletes from castilla y león, as well as the category of athletics with the highest number of losses, the most incident risk factors and the bio-psycho-social consequences that it leads to.

elaboration of a survey, based on two validated questionnaires to which 63 participants have answered, to carry out an analytical, transversal and observational study. all the participants are women, of age, federated in athletics and belonging to castilla y león. ui has a high prevalence (44.4%) in female athletes, being more common in those who practice long-distance races. as age and years of sport increase, the incidence of this pathology increases. absorbent pads are used by more than half of the incontinent women, while the rest wet their underwear. menopause, childbirth and surgery in the region are risk factors for utis, while the presence of urinary tract infections or candidiasis are not. the results affirm that urine leaks do not cause anxiety or depression, but they do affect your sporting life.

Eligibility criteria:
inclusion criteria: * female sex. * adulthood. * federated in athletics. exclusion criteria: * men. * those women who are no longer federated or who are minors.

Keywords: women health sports incontinence, urinary stress
postoperative pain after vitreoretinal surgery

Conditions: Postoperative Pain; Retinal Detachment

Summary: postoperative pain (pop) is frequently underestimated in general and little data are available particularly for pop after vitreoretinal surgery (vrs). the investigators will conduct a 1-year retrospective study on patients undergoing vrs at "careggi hospital" . the aim of the study will be to observe the amount of pop, its time course, factors associated with its appearance and finally the efficacy of the pain protocol that is in use.

post-operative pain (pop) is frequently underestimated, mostly after eye surgery, a type of surgery in which trauma is limited and pain is not investigated as patients are often discharged from the hospital within a few hours. good pop management can improve clinical outcome and patients' satisfaction and constitutes essential criteria for hospital discharge after day-case or ambulatory surgery. little data are available particularly for pop after vitreoretinal surgery (vrs). the investigators will conduct a 1-year retrospective study on patients undergoing vrs at "careggi hospital" , a teaching university hospital in italy. the aim of the study will be to observe the amount of pop after vrs, its time course, factors associated with its appearance and finally the efficacy of the pain protocol that is in use. pain will be evaluated according to the "numerical rating scale" (nrs), a 11-point numeric scale ranging from '0' which represents "no pain" and '10' which represents extreme pain at several intervals after surgery. analgesic consumption (in terms of type and amount of analgesics) and the efficacy of the analgesic protocol in use will also be recorded. factors possibly associated with pop (such as duration of surgery, presence of comorbidities, asa physical status, age, type of anesthesia (locoregional or general anesthesia)) will be analyzed. the associations between the principal outcome (amount of pop) and risk factors will be evaluated using a simple and multiple logistic regression model.

Eligibility criteria:
inclusion criteria: * vitreoretinal surgery exclusion criteria: * asa iv

Keywords: postoperative pain eye surgery vitrectomy pain control protocol
drainage is not necessary procedure after laparoscopic cholecystectomy due to severe acute cholecystitis

Conditions: Acute Cholecystitis; Empyema

Summary: laparoscopic cholecystectomy (lc) is the current preferred method of cholecystectomy. the role of routine drainage after lc to decrease postoperative morbidity is still an issue of considerable debate. the goal of this study was to assess to role of drains in lc, performed for acute inflamed gallbladder.


Eligibility criteria:
inclusion criteria: * acute cholecystis * laparoscopic cholecystectomy * karofsky performance scale \> 70 * no history of major operation exclusion criteria: * nyha class \> 3 * open cholecystectomy * no- compliance * intraoperative injuries * inadequate hemostasis
rct between upp and controls in adult osa

Conditions: Obstructive Sleep Apnea

Summary: to compare the effect of uvulopalatoplasty with no treatment in treating adult osa.

two arms: the intervention group undergo uvulopalatoplasty one month after baseline polysomnography (psg1) and a psg2 6 months after surgery . the control group perform psg 1 and are then waiting 6 months, thereafter undergo psg2, then surgery and psg3 6 months after surgery. all patients are followed for four years with psg. patients fill in questionnaires at psg sessions, and blood pressure control the morning after.

Eligibility criteria:
inclusion criteria: * ahi of 15 or more * friedmans stage i+ii * tonsil size 0-1 * bmi\<34 * ess värde \>7 * failed treatment with cpap and mandibular device exclusion criteria: * severe cardiovascular or neurological disease * asa iv * not interested in surgical treatment
respiratory therapy in copd exacerbations

Conditions: Obstructive Chronic Bronchitis With Acute Exacerbation

Summary: the purpose of this study is to determine effectiveness, feasibility and safety/tolerance of respiratory therapy in hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease.

acute exacerbation of chronic obstructive pulmonary disease (ae-copd) is defined as an event in the natural course of the disease characterized by a change in the patient's usual symptoms (dyspnea, cough and/or sputum) that may not be explained by the daily variations and requires a change in regular medication. because ae-copd result in impairment of both pulmonary and respiratory muscle functions, as well as an increasing impact on costs, priority should be given to interventions to slow the progression of the disease, prevention of exacerbations and reduce the risk of comorbidity. chest physiotherapy is often used in hospitalized patients with ae-copd with the aim of favoring the removal of secretions and thus to improve the ventilation perfusion (v/q), and therefore the function lung. the limited scientific evidence has determined that their use is controversial and not routinely recommended in clinical practice guidelines. current clinical guidelines in the treatment of copd are unable to rule on the application of respiratory therapy during exacerbations, since there is little scientific evidence of its benefits in the short and long term.

Eligibility criteria:
hospitalized patients with acute exacerbation of copd. inclusion criteria: * age over 18 years, * hospitalized patients and * acute exacerbation of copd. exclusion criteria: * previous history of any chronic respiratory disease and * not to have performed any kind of general or respiratory training in the previous 3 months.

Keywords: respiratory muscle training; high-intensity training
a study to assess the bioequivalence between brivaracetam tablet and dry syrup in healthy male japanese study participants

Conditions: Healthy Study Participants

Summary: the purpose of the study is to demonstrate the bioequivalence between the brv tablet and brv as dry syrup after a single oral dose in healthy japanese male study participants.


Eligibility criteria:
inclusion criteria: * study participant must be between 20 to 50 years of age (inclusive) at the time of signing the informed consent form (icf) * study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * study participant is of japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a study participant has all 4 japanese grandparents born in japan) exclusion criteria: * study participant has used other drugs, including over-the-counter medications, herbal/traditional medicines, or dietary supplements (excluding medicines for external use),with the exception of paracetamol, within 14 days before first administration of imp or has received a coronavirus disease 2019 (covid-19) vaccine within 7 days of initiating imp * study participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids, phenobarbital, isoniazid, phenytoin, rifampicin) within 2 months before the first administration of investigational medicinal product (imp) * study participant has a positive result for hepatitis b surface antigen, hepatitis c virus antibody test, human immunodeficiency virus antibody test, or syphilis at screening visit * study participant has donated blood or plasma or has experienced blood loss ≥400 ml within 90 days, ≥200 ml within 30 days, or has donated any blood or plasma within 14 days before first administration of imp * study participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of imp * consumption of more than 600 mg of caffeine/day (1 cup of coffee contains approximately 100mg of caffeine, 1 cup of tea approximately 30 mg, and 1 glass of cola approximately 20 mg)

Keywords: brivaracetam healthy study participants phase 1 brv
analysis of cortical excitability in neuropathic pain

Conditions: Neuropathic Pain; Cortical Excitability

Summary: the purpose of this study is to determine whether patients with neuropathic pain has abnormal excitability in somatosensory cortex and abnormal sensory-motor connections.

there are several brain areas responsible for neuropathic pain reported in functional image studies, including primary sensory cortex, insula, and anterior cingulate gyrus. however, it is few informations about the functional status of these areas. besides, the reason of the individual variability about the developement of neuropathic pain remains unknown. it is lack of satisfactory explanation about why some people developed neuropathic pain in certain diseased situation (for example, type 2 diabetes), while others do not. we hypothesis that patients with neuropathic pain has abnormal cortical excitability and plasticity in certain brain area. therefore developed neuropathic pain certain diseased condition while others not. therefore, we will use multimodal electrophysiology tools,such as transcranial magnetic stimulation, peripheral nerve stimulation, and contact heat evoke potential to monitor the cortical excitability and plasticity non-invasively.

Eligibility criteria:
inclusion criteria: * healthy volunteers * patients with pain resulted from dysfunction of peripheral or central nervous system * the disorders of peripheral nerves are diagnosed by nerve conduction study, quantitative sensory test, quantification of skin innervation or contact heat evoked potentials * lesion of central nervous system should be confirmed by neuroimage. exclusion criteria: * previous history of epilepsy, seizure disorders or major head injury * previous brain surgery or intracranial metalic implant * implanted devices as cardiac pacemaker * pregnant subjects * patient with severe cardiac or pulmonary disease who potentially cannot tolerate stress

Keywords: neuropathic pain cortical excitability transcranial magnetic stimulation contact heat evoked potential peripheral nerve stimulation neurotrophic factors
expanded access to suvn-g3031 (samelisant) for the treatment of subjects with narcolepsy

Conditions: Narcolepsy

Summary: the study is planned to provide expanded access treatment to subjects with narcolepsy who have completed the 2-week treatment phase and follow-up in study ctp2s13031h3 (nct04072380), and in instances when the investigator as well as the subject believe that the benefits outweigh the risks to continue the treatment with suvn-g3031.

the qualified subjects will be given 2mg of suvn-g3031 expanded access treatment for 30 days. at the end of 30 days if the subject wishes to continue the treatment, he/she will be provided with adequate investigational drug for next 30 days. this cycle will be repeated up to a maximum of 2 times (total duration of expanded access treatment up to 90 days).

Eligibility criteria:
inclusion criteria: 1. subjects who have completed the 2-week treatment phase and follow-up period of study ctp2s13031h3 (nct04072380) as planned and wish to continue unblinded treatment with suvn-g3031 (2 mg, qd). 2. subject must sign the icf to participate in the study. 3. the investigator after review of relevant information and in consultation with the subject believes that continued treatment following study ctp2s13031h3 could be beneficial to the subject. exclusion criteria: 1. any clinically relevant concomitant disease or aes/saes during the phase 2 study (ctp2s13031h3), which in the opinion of the investigator, makes the subject unsuitable for inclusion in the protocol. 2. has participated or is participating in any other clinical (investigational) study after completion of ctp2s13031h3 protocol (nct04072380).
exercise as a strategy to treat cognitive dysfunction in persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: many persons with multiple sclerosis ( ms) have problems with memory and thinking.exercise has been shown to improve memory and thinking in persons with diseases such as alzheimer's. this study will investigate whether a program of aerobic exercise can improve memory and thinking in persons with ms

persons with multiple sclerosis(ms)will be screened for eligibility and randomized to a protocol with two intervention arms. one group will have aerobic training on a recumbent cross trainer three times a week for 20-30 minutes/session. the other group will participate in stretching exercises at the same frequency and intensity.total training time will be six months.outcome measures will include tests of memory and thinking, and fitness measures.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ms complaints of cognitive problems able to ride a recumbent cross trainer exclusion criteria: * cardiopulmonary or structural disease that would limit ability to participate in exercise training on treatment with chemotherapy or natalizumab screening score of \>50 on pasat

Keywords: multiple sclerosis exercise cognition