Kornimate/medical-research-clean huggingface dataset:
telaprevir exposure and severe anemia in hcv infected patients treated by tri-therapy

Conditions: C Hepatitis, Tri Therapy

Summary: the risk of severe anemia is increased in patients treated by tri-therapy compared to patients treated by bitherapy. the underlying mechanisms involved in this toxicity remain unexplored but could also depend on the global exposure of telaprevir. the trough concentration or auc of telaprevir could therefore be a predictive factor of the onset of anemia in patients treated by ribavirin/peg-inf/telaprevir. the early measurement of telaprevir and ribavirin concentrations could help to manage hcv tri-therapy to improve tolerance and svr.


Eligibility criteria:
inclusion criteria: * man or woman older than 18 yr. 2- hcv genotype 1 infection as confirmed by a positive viral load 6 months after the selection visit or confirmed by the mean of a liver biopsy within 1 year before screening for the study. 3- patient with one of the following criteria: patient naive of any treatment against hcv infection or prior null responder patient: patient previously treated by ribavirin/peg-inf for at least 12 weeks and whom hcv viral load decline was \ 2 log at week 12 or prior relapser patient: patient previously treated by ribavirin/peg-inf for 48 weeks, with a negative viral load at the end of treatment and a positive viral load 6 months later 4- patient who has stopped his treatment for at least 12 weeks 5- patient who had a liver biopsy or a fibroscan within the 24 months before the start of the study with a metavir fibrosis score f ≥ 3. 6- patient who fulfills criteria for telaprevir treatment as defined by the licence 7- patients who accepts to use 2 contraceptive methods until 6 months after the end of the treatment 8- patient who had given his written informed consent 10- patient insured under the french social security system exclusion criteria: 1- infection/co-infection by hcv genotype different than genotype 1 2- patient with a medical contraindication to peg-inf or ribavirin 3- patient with history of allergy or intolerance to telaprevir 4- patient using contraindicated drugs 5- patient with history of decompensated liver disease and/or presenting biochemical measurements as follows at the inclusion visit: * international normalized ratio (inr) \> 1,5 * albumin \<3,3 g/dl * total bilirubin\>1,8 n apart for patient with gilbert syndrome 6- liver disease from other causes 7- patient with hepatocellular carcinoma or history of cancer 8- patient with a history of graft transplantation and treated by immunosuppressive drugs 9- patient who are regularly treated by corticosteroids 11- patient with hemophilia or coagulation troubles 12- hiv or hbv co-infection 14- patient with body mass index\> 30 kg/m2.

Keywords: c hepatitis, telaprevir concentration, ribavirin oncentration, anemia
safety and immunogenicity of trivalent split influenza vaccine using the strain composition 2007/2008

Conditions: Seasonal Influenza; Vaccine

Summary: annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and elderly subjects


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry * available for all the visits scheduled in the study and able to comply with all study requirements * in good health as determined by: medical history, physical examination, clinical judgment of the investigator exclusion criteria: * n/a

Keywords: influenza vaccine
efficacy and safety of etanercept in active ra despite methotrexate therapy in japan

Conditions: Rheumatoid Arthritis

Summary: multi-center, parallel-group, randomized, open control study. all patients will be selected to two treatment groups. 1. etanercept alone treatment group (25mg, twice/week, s.c.) 2. etanercept combined with mtx group (25mg, twice/week, s.c.+mtx 6-8mg/week)


Eligibility criteria:
inclusion criteria: * patients had to be at least 18 years of age * fulfilled the 1987 revised classification criteria for ra by in american college of rheumatology (acr) * met the guidelines for the proper use of etn in japan (having at least 6 tender joints and 6 swollen joints * either serum c-reactive protein more than 2 mg/dl or esr no less than 28 mm at 1 hour, with adequate safety profiles) * be acr functional class i-iii * have been receiving mtx 6 mg/week for a minimum of 3 months at a stable dose for at least 4 weeks at the time of study enrollment exclusion criteria: * patients who required concurrent use of prednisone (psl) \>10 mg/day, or its equivalent, were excluded from study entry * the start of dose increment of psl equivalents within 3 months of the study enrollment * experience of antirheumatic therapy except for mtx and psl equivalents * previous treatment with etn or any other biological treatment
serial exhaled breath ph monitoring

Conditions: Gastroesophageal Reflux

Summary: this study will seek to determine the amount of acids a person with a chronic cough that is suspected to be related to acid reflux breathes out after coughing. the study will also seek to determine if this measurement can predict the best treatment for the cough. subjects with a chronic cough which is suspected to be related to acid reflux for which their doctor has prescribed a proton pump inhibitor medication will be enrolled in this study.

acid reflux has been considered to be a key contributor to cough, particularly in patients with obstructive lung diseases. however, diagnosis has relied upon either responsiveness to high dose twice daily administration of proton pump inhibitor therapy or by 24 hour esophageal ph probes. this study is designed to provide information for the development of a clinically useful diagnostic (exhaled breath condensate ph) to identify the contribution of acid reflux to cough. exhaled breath condensate (ebc) ph has been well documented to reflect airway acidification. acid reflux to the level of the hypopharynx, which is a key common trigger of acid reflux induced cough, acidifies the airway sufficiently to be identified with ebc ph assays. the association of low ebc ph with an immediately preceding cough strongly suggests an association of the cough with an airway acid event, and even if the acidity is not prolonged, acid reflux becomes highly suspect. this study will examine the ability of ebc ph measurements to prognose the likelihood of a positive response to acid blockade with proton pump inhibitor therapy in subjects with chronic cough.

Eligibility criteria:
inclusion criteria: * outpatient * 5 years of age and older * cough lasting a minimum of 3 weeks * has been prescribed a proton pump inhibitor as a single therapeutic and diagnostic effort to control the cough exclusion criteria: * inability to perform serial exhaled breath condensate collections at home * unwillingness to initiate proton pump inhibitor therapy as prescribed by physician * other changes planned in therapy, such as initiating or discontinuing cough suppressant therapy, initiating or augmenting antibiotic therapy, initiating or augmenting anti-inflammatory therapy * previous treatment of respiratory symptoms with proton pump inhibitor therapy * current treatment with angiotensin converting enzyme inhibitor medication or h2 antagonists * regular exposure to an environmental irritant

Keywords: cough gastroesophageal reflux
laser acupuncture for dry eye

Conditions: Dry Eye

Summary: subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. the effects of laser acupuncture therapy for patients with dry eye are investigated.

objective: dry eye is a common ophthalmologic disorder causing ocular discomfort in daily life. the investigators aim to investigate the effects of laser acupuncture therapy for patients with dry eye. methods: 200 subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. the subjects are treated at acupoints including bl2, te23, st2, li4, st36, and gb37 using verum or sham laser acupuncture during 3 sessions per week. after 4 and 12 weeks of treatment, the differences in the tear film break-up time, schirmer test, visual analogue scale, ocular surface disease index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way anova.

Eligibility criteria:
inclusion criteria: * 20 \< age \< 65, with aggravated dry eye (one or both eyes), evaluated by ophthalmologist and provides informed consent. * tear film break-up time \< 10 s * schirmer's strips with anesthesia \< 5mm/ 5min exclusion criteria: * presence of eye lesions, received operation for eye during the past three months, combination of other ophthalmic medication, or using contact lens * pregnancy, diabetes mellitus, vitamin a deficiency, sequelae of bell's palsy, hemodialysis * critical illness such as stevens-johnson syndrome, etc * has taken or needs active treatment (including chinese medicine) * presence of a pacemaker; history of seizure or epilepsy; using immunosuppressants; cancer; infectious disease of skin * does not meet the physician's assessment for recruitment * lack of informed consent.

Keywords: dry eye laser acupuncture traditional chinese medicine
effectiveness of enhanced external counterpulsation for post-acute stroke patients

Conditions: Cerebrovascular Accident (CVA)

Summary: the goal of this clinical trial is to learn if there benefits combine enhanced external counterpulsation (eecp) with the standard post-acute care (pac) rehabilitation treatment to treat stroke patients.. the main questions it aims to answer are: what is the feasibility of combining eecp and pac? does eecp combined pac rehabilitation improve functional outcomes of post-stroke patients? researchers will compare standard pac rehabilitation and eecp combined pac rehabilitation to see if eecp has benefits to treat stroke.


Eligibility criteria:
inclusion criteria: * patients with acute cerebrovascular disease, within 1 month after acute attack. * stable medical condition: (1). neurological condition: the neurological condition has not deteriorated for more than 72 hours. (2). vital signs including blood pressure, heartbeat, and body temperature are stable or controllable for more than 72 hours. (3). no complications such as infection, blood abnormalities, gastrointestinal bleeding, or stable or controllable after treatment. * those whose functional status is moderate to moderately severe functional impairment (mrs 3-4) and who are judged by the medical team to have active rehabilitation potential: (1). have basic cognition, learning ability and willingness. (2) have sufficient physical strength: able to maintain a sitting position on a wheelchair or bed edge for at least one hour with support. (3). be able to actively participate in rehabilitation treatment plans. * aged over 20 years old exclusion criteria: * patients with atrial fibrillation/arrhythmia. * within 2 weeks after cardiac catheterization or arterial puncture at the femoral artery puncture site. * decompensated heart failure (nyha class 3 or 4). * left ventricular ejection fraction (ef) \< 30%. * moderate or severe aortic regurgitation. * persistent and uncontrolled hypertension (blood pressure persistently \>160/100 mmhg). * bleeding tendency. * active phlebitis/venous disease of the lower extremities. * severe vascular occlusive disease of the lower extremities. * the presence of documented aortic aneurysm/dissection requiring surgical repair. * pregnancy.

Keywords: cerebrovascular accident (cva) enhanced external counterpulsation post-acute care
cyclosporine on day zero as prophylaxis for cytokine release syndrome

Conditions: Stem Cell Transplant Complications; Cytokine Release Syndrome

Summary: phase ii, randomized controlled, unblinded clinical trial. will evaluate whether the administration of oral cyclosporine started on day 0 of transplantation is effective in reducing the incidence of cytokine release syndrome (crs) in patients who receive an outpatient haploidentical transplant.

crs is usually limited after the administration of post-transplant cyclosporine (pt-csa) administered on days +3 and +4, however, there is no standard prevention or treatment regimen for crs after haplo-tcph and therapeutic behavior has usually been adopted. sample of 32 patients between the ages of 16 and 60 who receive their first haploidentical transplant at our center. in the control group, csa 6 mg/kg orally divided into two doses per day starting in the morning on day +5 of the transplant, mycophenolic acid 1 gram orally (2 tablets of 500 mg) from day +5 post-transplant and post-transplant cyclophosphamide (pt-cy) at 50 mg/kg per day on days +3 and +4 and in the experimental group, csa 6 mg/kg orally divided into two doses per day starting in the morning on day 0 after transplantation, mycophenolic acid 1 gram orally (2 tablets 500 mg) from day 0 post-transplant and pt-cy at 50 mg/kg per day on day +3 and +4. will document the presence of crs and its degree, as well as the need for hospitalization, associated infectious processes, and a day to recover neutrophils and platelets. additionally, 4 blood samples will be taken from the patients to determine the level of cytokines and c-reactive protein.

Eligibility criteria:
inclusion criteria: * patients between 16-60 years of age who receive their first haploidentical transplant. exclusion criteria: * patients positive for the human immunodeficiency virus (hiv), hepatitis b or c virus * pregnancy or lactation * patients with documented infection at the time of transplantation * presence of previous autoimmune diseases * inability to tolerate the oral route

Keywords: cyclosporin haploidentical outpatient
intravenous cannulation in children during sevoflurane induction

Conditions: Catheterization

Summary: this interventional simple-blind,randomized trial has included 90 children of american society of anesthesiologist (asa) physical status i or ii aged between 1 to 12 years of either sex, scheduled for for outpatient minor surgery under general anesthesia. this study examined whether one should make iv attempts during the early induction period (at 60 seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.

we conducted a prospective randomized study, after obtaining institutional review board approval, which didn't require written parental consent. children age 1-12 years, undergoing elective general anesthesia via an inhalation induction were randomized to one of three groups of 30 patients each one, for iv placement, either 60s (group e), 90 or 120 s (group l) following loss of lid reflex. movement on iv placement and incidence of laryngospasm were determined. difficulty with iv placement was also recorded. statistical analysis included contingency testing, anova, and non parametric testing. a p-value \<0.05 was considered significant.

Eligibility criteria:
inclusion criteria: * children with american society of anesthesiologist (asa) physical status i or ii * age between 1 and 12 years of either sex, * were scheduled for outpatient minor surgery under general anesthesia exclusion criteria: * age \ 12 years * patients with full stomach * a history of gastric reflux * history of convulsions, cardiovascular or neuromuscular disease * suspected difficult airway and hyper-reactive airway disease

Keywords: sevoflurane, catheterization, anesthetics inhalation, child
assessing the role of mitochondrial dysfunction in primary progressive multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this project is to study genetic determinants of mitochondrial impairment in primary progressive multiple sclerosis. specific aims are: 1) identify mitochondrial-related pathways, inherited and somatic mitochondrial dna mutations associated to primary progressive multiple sclerosis, 2) functionally assess the identified genetic alterations.

multiple sclerosis is a major cause of neurological disability, with a high socio-economic impact that increases as disability progresses. effective treatment of primary progressive multiple sclerosis is still an unmet need and the underlying neurodegenerative processes have to be fully investigated. the purpose of this project is to study genetic determinants of mitochondrial impairment in primary progressive multiple sclerosis. altered mitochondrial pathways will be investigate, as well as inherited and tissue-specific somatic mitochondrial variations associated with primary progressive multiple sclerosis.

Eligibility criteria:
inclusion criteria: * patients affected by primary progressive or relapsing remitting multiple sclerosis * patient able to provide informed consent exclusion criteria: * individuals with \< 18 years * patients not affected by primary progressive or relapsing remitting multiple sclerosis

Keywords: multiple sclerosis mitochondria
relationship between central sensitization symptoms and cognitive dysfunction in fibromyalgia.

Conditions: Fibromyalgia; Cognitive Dysfunction; Central Sensitisation

Summary: the aim of the study is to investigate the relationship between central sensitization parameters and cognitive dysfunction in patients with fibromyalgia.the main questions it aims to answer are: do central sensitization symptoms affect cognitive dysfunction in patients with fibromyalgia? to what extent do central sensitization symptoms affect objective and subjective cognitive complaints in fibromyalgia patients? how do cognitive complaints relate to other clinical parameters, including disease severity, in these patients?

central sensitization is defined as an increase in pain sensitivity with amplification of neuron-derived signals in the central nervous system. fibromyalgia is a disease characterized by chronic widespread pain, and although its etiology and pathophysiology are still not fully known, it is considered a major member of the group of diseases known as central sensitivity syndromes, which progress with impaired pain regulation. fibromyalgia negatively affects the patient's functionality in various ways. one of these is cognitive dysfunction, and previous studies have shown that fibromyalgia patients experience significant deterioration in all parameters related to cognitive function compared to healthy controls. central sensitization has been shown to be associated with comorbidities such as depression, anxiety, sleep disorders and fatigue in many disease groups, including fibromyalgia, and data on its effect on cognitive dysfunction are limited. a study found that impaired conditioned pain modulation, one of the methods used in the evaluation of central sensitization in fibromyalgia patients, was associated with cognitive dysfunction.in addition, cognitive impairment in these patients is associated with a decrease in the quality of life of the patients and is suggested to be one of the important clinical findings of the disease. considering all these data, it seems likely that central sensitization negatively affects cognitive function in fibromyalgia, and this study aimed to examine in detail the relationship between central sensitization and cognitive dysfunction in fibromyalgia patients.

Eligibility criteria:
inclusion criteria: * being diagnosed with fibromyalgia according to american college of rheumatology 2016 criteria * being between 18-65 years old * being literate * accepting to participate in the study exclusion criteria: * concomitant systemic inflammatory disease, central nervous system disease (cortical involvement), active infection and malignancy history * history of illness that may lead to cognitive impairment * being \ 65 years old * being illiterate * not accepting to participate in the study

Keywords: fibromyalgia cognitive dysfunction central sensitisation
study on genetically affected sporadic thoracic aortic aneurysm and dissection

Conditions: Dissection of Aorta, Thoracic; Aneurysm of Aorta, Thoracic

Summary: mortality of thoracic aortic aneurysm and dissection (taad) remains high because of the huge blood lost from the aorta. questions about the potentially genetic effects on sporadic taad are raised by researchers to explore the possible mechanisms leading to sporadic taad and to establish new clinical approaches to prevent taad-caused adverse clinical outcomes. this study is intended to collect the gene information in sporadic taad patients and to explore the relationship between genetic variation and the incidence of sporadic taad for further study.

thoracic aortic dissection (tad) is a critical clinical condition partly due to the rupture of aortic aneurysm. mostly, surgical treatment can reduce the symptoms and extend life span of patients with thoracic aortic aneurysm and dissection (taad). however, mortality of taad remains high because of the huge blood lost from the aorta. sporadic taad was considered to be a server consequence of hypertension, though most patients with hypertension won't have taad as their final outcomes. previous studies have revealed the associations between genetic abnormalities and familial taad, and genetic tests have applied to assist the diagnosis of certain taad. therefore, the potentially genetic effects on sporadic taad are explored by researchers to understand the possible mechanisms leading to sporadic taad and to establish new clinical approaches to prevent taad-caused adverse clinical outcomes. this study is intended to collect the gene information in sporadic taad patients and to explore the relationship between genetic variation and the incidence of sporadic taad for further study.

Eligibility criteria:
inclusion criteria: * patients with thoracic aortic aneurysm and dissection not due to trauma exclusion criteria: * inability of the patient, parent or guardian to give consent * unwillingness to provide a blood specimen or participate in the study

Keywords: dissection aneurysm thoracic aorta
postoperative pain control after periarticular injection during total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: this study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (tkr) surgery to see if it reduces postoperative pain levels. the injection is a combination of various medications which are thought to reduce pain levels. approximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. pain scores after the surgery will be compared between the two groups. all patients will also receive a long-acting (24 hours) morphine injection during surgery. the hypothesis is that those participants receiving intrathecal duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal duramorph alone at 48 hours postoperatively.

data collection: data will be collected from the patient's medical record after discharge variables include: * age * sex * bmi * upat score (universal pain assessment tool)- this is assessed hourly postoperatively by nursing staff on orthopedics unit * patient's assessment of acceptability of pain * upat score as assessed by physical therapy pre and post therapy sessions * duramorph dose * time patient arrived on the orthopedic unit * length of ambulation during physical therapy sessions * amount of supplementary opioids (measured in morphine equivalents) * use of anti-emetics * any complications of surgery including venous thromboembolic event, cardiac event, bleeding event * length of hospital stay the pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records.

Eligibility criteria:
inclusion criteria: * age 18 or older * written informed consent exclusion criteria: * pregnant women * creatinine clearance less than 60 ml/min * bmi greater than 40 * currently use greater than 80mg morphine-equivalents daily (pre-operatively) * receive a unicondylar knee replacement