Kornimate/medical-research-clean huggingface dataset:
prophylaxis of psychiatric symptoms during anti-hcv treatment

Conditions: Hepatitis C

Summary: the treatment of chronic hepatitis c with peginterferon and ribavirin is highly effective but is hampered by peginterferon-induced psychopathology. prevention of peginterferon-induced psychopathology with selective serotonin reuptake inhibitors (ssri's) (paroxetine) has been shown to be effective in patients treated with interferon for malignant disease. the aim is to study the effects of prophylactic treatment with escitalopram (another ssri) on peginterferon-associated psychopathology in patients treated with peginterferon and ribavirin for chronic hepatitis c.

the treatment of chronic hepatitis c with peginterferon and ribavirin is highly effective but is hampered by peginterferon-induced psychopathology. prevention of peginterferon-induced psychopathology with ssri's (paroxetine) has been shown to be effective in patients treated with interferon for malignant disease. the aim is to study the effects of prophylactic treatment with escitalopram on peginterferon-associated psychopathology in patients treated with peginterferon and ribavirin for chronic hepatitis c. design: double blind, randomized controlled trial with two arms, maximum 40 patients per arm. patients, starting with peginterferon and ribavirin, will be randomized to receive escitalopram therapy 10 mg per day (however, 5 mg in the first two weeks) or placebo. study population and selection: eighty patients receiving peginterferon alfa-2a (pegasys 180 microgram) and ribavirin (copegus 400 mg twice daily) will be included in the study. aims of the study: 1. to asses whether prophylactic treatment with escitalopram avoids significantly the occurrence of peginterferon-induced psychiatric disturbance; defined as an increase of two points on observer-based rating scales reflecting anxiety (bas:briefanxietyscale), loss of concentration, depression and loss of impulse control (montgomery and asberg depression rating scale: madrs), and 2. to assess the frequency of major depression according to dsm iv criteria, in the escitalopram and placebo-treated patients.

Eligibility criteria:
inclusion criteria: * male and female patients between 18-70 years of age * evidence of chronic hepatitis c by detectable serum hcv-dna * hepatitis c genotype 1,2,3 or 4 * indication for antiviral therapy of hepatitis c according to current clinical guidelines * written informed consent exclusion criteria: * history or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigator, unsuitable for the study * abnormal thyroid stimulating hormone (tsh) * presence of contra-indications for antiviral therapy * concurrent psychiatric axis i diagnosis according to diagnostic and statistical manual of mental disorders, fourth edition (dsm iv) criteria, as the presence of a major depressive episode, bipolar disorder or psychotic disorder. * concurrent use of psychotropic drugs such as mao-inhibitors, st john's wort, lithium and 5 ht-agonists and antiepileptics.

Keywords: hepatitis c peg-interferon psychiatric side-effects
efficacy and safety on prouk for stemi patients in china

Conditions: STEMI

Summary: the purpose of the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those st elevated myocardial infarctions patients, it is designed as a multicenter, active controlled, single blinded study. the primary endpoint is to assess the coronary recanalization 90 minutes after thrombolysis. the secondary endpoint is to evaluate the mortality rate at day 30.

the purpose of the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those st elevated myocardial infarctions patients, it is designed as a multicenter, active controlled, single blinded study. the primary endpoint is to assess percentage of patients achieve the coronary recanalization 90 minutes after thrombolysis. the secondary endpoint is to evaluate the mortality rate at day 30.

Eligibility criteria:
inclusion criteria: * chest pain \> 30 minutes, while \<12 hours * expected pci related delayed time \> 60 minutes, or door to balloon time \>90 minutes * ecg confirmed stemi. * age: 18--75 years old * weight \<=85kg * consent to participate in this study exclusion criteria * evidence of cardiac rupture; * ecg: new left bundle branch block; * thrombolysis contradictions * any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. \< 3 months); * active bleeding or known bleeding disorder. * recent administration of any i.v. or s.c. anticoagulation within 12 hours includingunfractionated heparin, enoxaparin and/or bivalirudin or current use of oral anticoagulation(warfarin or coumadin); * uncontrolled hypertension, defined as a single blood pressure measurement ≥ 180/110 mm hg (systolic bp ≥ 180 mm hg and/or diastolic bp ≥ 110 mm hg) prior to randomisation; * major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction); prolonged or traumatic cardiopulmonary resuscitation (\> 10 minutes) within the past 2 weeks major surgery pending in the following 30 days;
ethical and psychological support for health care professions in intensive care units in the covid19 pandemic context: adequacy with needs and psychological impact crisis and post-crisis

Conditions: Psychological Strain

Summary: the intensive care unit occupies a particular place in our health care system. the urgency of the clinical situations, the proportion of deaths encountered, and the daily workload is likely to generate suffering among staff. the health crisis linked to sars-cov-2 is unprecedented and has leads to the unprecedented mobilisation of care providers, particularly in the icu. faced with the massive and growing influx of patients, human, therapeutic and material resources are overwhelmed and the teams are faced with an unusually heavy workload in a context of extreme tension. these professionals are thus exposed to a risk of over-investment, in a context of acute and repetitive stress, over an indeterminate period of time combining workload, emotional intensity with specific ethical issues, simultaneously affecting the professional sphere but also the personal and family sphere (confinement, risk of contamination). now more than ever, the mental health of caregivers is an important concern, as highlighted by the ccne. mental health is understood in the way in which the individual responds specifically to work-related suffering by developing individual and collective defensive strategies. thus, the issue of mental health in the icu cannot be considered without taking into account the strategies that professionals put in place to combat stress and to contribute or not to the construction and stabilization of the work collective (collaboration, support). ethical and/or psychological support systems have been set up in most of the establishments involved in the care of covid-19 patients. however, the adequacy of these systems relative to the needs of professionals during and after the crisis is not yet known. we hypothesize that the psychological and social repercussions of this pandemic as well as the individual and collective strategies deployed by icu care providers to deal with it will evolve in view of the progression of the crisis but also of the various types of support, particularly psychological and/or ethical, available to them.


Eligibility criteria:
inclusion criteria: * the study population is the entire icu staff of the participating centres, whether they are permanently or transiently assigned to these units and/or the institution, whether they are students or not. professionals involved in psychological and ethical support structures may also be interviewed to provide the information necessary to describe and evaluate the organisations and their evolution. exclusion criteria: * na
validation of the greek version of the confusion assessment method diagnostic algorithm (cam) and the nursing delirium screening scale (nu-desc) and their inter-rater reliablity

Conditions: Postoperative Delirium

Summary: this study attempts to validate the greek version of the cam diagnostic algorithm and nu-desc in patients undergoing surgery under general anesthesia.

accurate diagnosis for greek speaking patients suffering from postoperative delirium is limited by the need for a translation of standardized tools that were investigated for their inter-rater reliability/agreement. our primary aim is to validate the greek version of the cam diagnostic algorithm and nu-desc in patients undergoing surgery under general anesthesia. our secondary aim is to estimate the diagnostic accuracy of nudesk in our population. this study will provide the first official greek translation of cam and nu-desc, according to the ispor guidelines, and the first evaluation of their inter-rater agreement.

Eligibility criteria:
inclusion criteria: 1. adult patients over 60 years of age 2. an american society of anesthesiologists (asa) physical status i to iii 3. undergoing elective non-cardiac surgery under general anaesthesia 4. native speakers of the greek language 5. eligible to leave the post-anaesthesia care unit 6. an expected in-hospital stay of at least 24 hours following surgery exclusion criteria: 1. refused to participate or sign the informed consent form 2. surgery or anaesthesia within the last 30 day 3. any prior or current history involving an affliction of the central nervous system 4. severe hearing or visual impairment 5. psychiatric disorders 6. sa core less than 5 according the geriatric depression scale (gds-15) 7. a score less than 4 for females and less than 2 for males according to the lawton-brody instrumental activities of daily living scale (i.a.d.l.) 8. alcohol consumption less than 35 units/week 9. drug dependence 10. previous neuropsychological testing 11. haemodynamical instability 12. peri-procedural desaturation (one or more events of spo2\<80% for more than 2 minutes)
stem cell therapy in incurable neurological disorders

Conditions: Neurological; Disorder, Nervous System

Summary: the purpose of the study was to analyze the benefit of autologous mononuclear cell therapy in incurable neurological disorders.


Eligibility criteria:
inclusion criteria: * diagnosed cases of incurable neurological disorders * age above 6 months exclusion criteria: * presence of acute infections such as human immunodeficiency virus/hepatitis b virus/hepatitis c virus * malignancies * bleeding tendencies * pneumonia * renal failure * severe liver dysfunction * severe anemia \[hemoglobin \< 8\] * any bone marrow disorder * space occupying lesion in brain * other acute medical conditions such as respiratory infection and pyrexia * pregnancy * lactation

Keywords: incurable neurological disorders autologous mononuclear cell therapy stem cells
study of pitavastatin in elderly patients with primary hypercholesterolemia or combined dyslipidemia

Conditions: Hypercholesterolemia; Dyslipidemias

Summary: this is an open-label extension study of nk-104-306 (nct00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.

this was an open-label study of 60 weeks duration in elderly patients (≥65 years) with primary hypercholesterolemia or combined dyslipidemia who completed the 12 week treatment in study nk-104-306 and who met the inclusion/exclusion criteria. patients who qualified started open-label treatment with pitavastatin 2 mg qd. the dose of pitavastatin could be increased to 4 mg qd after at least 8 weeks of treatment at 2 mg qd, in patients who failed to attain their ldl-c target.

Eligibility criteria:
inclusion criteria: * greater than or equal to 65 years of age * primary hypercholesterolemia * combined dyslipidemia * completed study nk-104-306 (nct00257686) exclusion criteria: * failed to complete study nk-104-306(nct00257686)

Keywords: pitavastatin hypercholesterolemia combined dyslipidemia
prevalence and effect of lifestyle modification on clinical outcomes and cost-effectiveness ratio for sarcopenia

Conditions: Sarcopenia

Summary: the purposes of this study were to investigate the prevalence and risk factors for sarcopenia in chinese adults and elderly, and evaluate the effect of lifestyle modification project (lmp) on clinical outcomes, quality of life and cost-effectiveness ratio.


Eligibility criteria:
inclusion criteria: * age\>=18 year the participants must have basic cognitive function and communication must be able to provide a written informed consent exclusion criteria: * age\<18 year concurrent severe cardiac disease, unstable diabetes mellitus,uncontrolled chronic disease,liver and renal failer, which may significantly interfere with study compliance. participants received any drugs or supplements known to influence effcet size,such as protein powder, calcium, or vitamin d before the 3 months preceding the study. participants with electronic or mental device

Keywords: prevalence; lifestyle modification; clinical outcomes
breast mesh used in two-staged breast reconstruction

Conditions: Breast Cancer; Radiation; Breast Reconstruction; Synthetic Mesh

Summary: this is the first prospective randomized and controlled study on the efficacy and safety of tiloop® bra mesh in patients with expander-implant breast reconstruction. the investigators hypothesize that incoporating tiloop bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.


Eligibility criteria:
inclusion criteria: 1. diagnosed with breast cancer 2. more than 18 years old 3. karnofsky performance status (kps) larger than 80 4. no clinical or imaging evidence of distant metastasis 5. bmi \< 35kg/m2 6. patients with no or mild breast ptosis 7. no severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function. 8. mental health patient - exclusion criteria: 1. patients with distant metastasis of breast cancer or local recurrence; 2. past ipsilateral breast/chest wall radiation; 3. inflammatory breast cancer, stage iv breast cancer 4. history of severe allergic or specific constitution; 5. mental illness; 6. drug/alcohol abuse; 7. pregnancy, lactation, or impregnated during the trial period; 8. non-eligible to the study enrollment based on researchers' discretion -

Keywords: breast cancer breast reconstruction radiation synthetic mesh
evaluation of the efficacy and safety of mv140

Conditions: Urinary Tract Infection Bacterial

Summary: the purpose of the study is to evaluate the efficacy and safety of a biological vaccine (mv140) in women with recurrent urinary tract infections (ruti) compared with a placebo group.

double blind parallel placebo controlled study. the subjects will receive medication during three or six months and will be followed up during another twelve months.

Eligibility criteria:
inclusion criteria: * women who gave their informed consent. * age between 18 and 75 years. * must be able to meet the dosage regimen. * subjects who had had at least 5 episodes of cystitis in the last 12 months. * subjects who had not responded to hygienic-sanitary measures and / or suppressive treatment and / or postcoital prophylaxis. * subjects who were free of urinary tract infections at the time of inclusion in the study. exclusion criteria: * had not given their informed consent. * age was not within the established age range. * could not offer cooperation and/or had severe psychiatric disorders. * presented a pathologic post-micturition residue. * presented moderate to severe incontinence. * presented genital tumours. * presented urinary tract tumours. * presented lithiasis. * presented alterations in the immune system. * presented complicated utis.

Keywords: vaccine recurrent urinary tract infections (ruti)
effect of fibrin sealant on early wound healing

Conditions: Periodontitis

Summary: the aim of this randomized controlled clinical trial is to compare wound healing after the use of fibrin sealant and sutures for gum surgeries. 15 patients requiring gum surgery for their periodontal (gum)problems are selected and invited. two regions will be operated in a selected patient. one region will receive fibrin sealant (test site) and the other region will get sutures (control site). wound healing will be assessed by evaluating inflammatory markers, interleukin 1beta and interleukin 8, from a non invasively collected gum fluid. hypothesis. fibrin sealant use will result in less inflammation seen through reduced levels of interleukin (1beta and 8) compared to use of sutures.


Eligibility criteria:
inclusion criteria: 1. a subject has to be between the ages of 18 and 60 years. 2. severe periodontitis: presence of a jaw with each quadrant having atleast 4 teeth with a probing depth of ≥ 6mm and is indicated for periodontal flap surgery. 3. compliance: only patients with optimal compliance, as assessed during the cause-related phase of therapy, are selected. 4. good oral hygiene: full-mouth plaque score (fmps) \< 25%. 5. low levels of residual infection: full-mouth bleeding score (fmbs) \< 25%. 6. endodontic status: teeth had to be vital or properly treated with root canal therapy exclusion criteria: 1. history of any systemic disease such as diabetes mellitus, osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy. 2. current or former smokers. 3. had undergone periodontal therapy in the past 6 months, or exhibit poor plaque control after phase i therapy. 4. mobility of selected teeth. 5. pregnant or lactating women.

Keywords: fibrin sealant tissue adhesive wound healing interleukin 1 beta interleukin 8
effect of menstrual cycle on vaginal blood flow in pre-menopausal healthy women.

Conditions: Sexual Dysfunction, Physiological

Summary: the pfizer developed heat wash-out (hwo) system is a software controlled electromechanical system designed to measure vaginal wall blood flow. a small vaginal probe is attached to a control unit. output data is collected on a pc. by measuring the clearance of heat from the heated probe, a direct measure of absolute blood flow can be obtained. the study will assess changes in vaginal blood flow across the menstrual cycle following visual sexual stimulation.

medical device development

Eligibility criteria:
inclusion criteria: * pre-menopausal healthy women aged 18-45 with regular, natural menstrual cycles. * subjects must be void of female sexual disorder. exclusion criteria: * pregnant or lactating women * postmenopausal subjects * subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurologic disease.
an open-label long-term study of pregabalin for the treatment of central neuropathic pain

Conditions: Spinal Cord Diseases; Spinal Cord Injuries; Neuralgia; Pain

Summary: the purpose of this study is to assess the safety of the long-term use of pregabalin at doses up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain, post stroke pain, and multiple sclerosis pain).


Eligibility criteria:
inclusion criteria: inclusion criteria for subjects to be shifted from study a0081107 * subjects who completed the 18-week study period in study a0081107 conducted for chronic neuropathic pain after spinal cord injury; * subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding study a0081107 (v7); inclusion criteria for subjects to be new participants in this study * subjects with central neuropathic pain after stroke or multiple sclerosis; * at least 6 months have passed after the onset of central neuropathic pain; * pain vas at least 40mm in visit 1 and visit 2; exclusion criteria: * creatinine clearance \< 60 ml/min; * platelet count \< 100 × 103/mm3 ; white blood cell (wbc) count \< 2500 / mm3; neutrophil count \< 1500/ mm3; * subjects who are expected to require surgery during the trial;

Keywords: central nervous system diseases therapeutic uses wounds and injuries trauma nervous system pregabalin
efficacy in controlling myopia in young children using a novel spectacle lens

Conditions: Myopia; Juvenile Myopia; Myopia Progression

Summary: this is a conventional efficacy trial to validate the results from previous clinical trials for younger children; the 12-month efficacy results will be used to predict the 3-year treatment efficacy. this is a randomized, controlled (1:1), multisite, subject- and observer-masked, 2-arm parallel group study.


Eligibility criteria:
inclusion criteria: 1. children 6 - 8 years of age (inclusive) at time of informed consent/assent; 2. spherical equivalent refractive error between -0.75 and -4.50 d inclusive (by manifest refraction) in each eye; 3. astigmatism if present, less than or equal to -1.25 dc (by manifest refraction) in each eye; 4. best corrected visual acuity by manifest refraction of +0.10 logmar (20/25 snellen equivalent) or better in each eye; 5. the difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 1.50 d; 6. agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day); 7. ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes at the baseline visit; 8. willingness to participate in the trial for 24 months without contact lens wear; 9. the subject's parent(s) or legal guardian(s) must read, understand and sign the statement of informed consent and receive a fully executed copy of the form. exclusion criteria: 1. subject has previously or currently wears contact lenses (greater than 1-month usage); 2. current or prior use of bifocals, progressive addition spectacle lenses 3. current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology); 4. amblyopia in either eye; 5. strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction; 6. any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, marfan syndrome or other connective tissue disorder, down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)\]; 7. known allergy to proparacaine, tetracaine, or tropicamide; 8. participation in any investigational clinical study within 30 days of the baseline visit; 9. subject's sibling or other household member is already enrolled in this trial.
evaluating patient satisfaction after cataract surgery with multifocal intraocular lens

Conditions: Cataract

Summary: multifocal lens allow most patients to be spectacle-free after cataract surgery. most studies published up-to-date have focused on visual acuity, but not on patient-reported outcomes. since some patients with very good postoperative visual acuity report being very uncomfortable after surgery, the aim of this study is to evaluate if patient satisfaction is correlated with other outcomes, such as low-contrast visual acuity, contrast sensitivity, photic phenomena and ability to tolerate defocus. patients who have undergone surgery with bilateral multifocal intraocular lens implantation will be carefully evaluated 3 months after surgery to try to determine the factors that correlate with patient reported outcomes as evaluated with the catquest sf-9 questionnaire.


Eligibility criteria:
inclusion criteria: * previous bilateral cataract surgery * bilateral implantation of multifocal intraocular lens exclusion criteria: * presence of ocular pathologies * intra- or postoperative complications

Keywords: multifocal intraocular lens trifocal intraocular lens extended depth of focus lens