Kornimate/medical-research-clean huggingface dataset:
association of clopidogrel therapy and stent thrombosis

Conditions: Coronary Artery Disease

Summary: the purpose of real-late (correlation of clopidogrel therapy discontinuation in real-world patients treated with drug-eluting stent implantation and late coronary arterial thrombotic events) trial is to assess the relationship between clopidogrel use and long-term rates of cardiac death or mi after des implantation in real-world practice and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.

an observational analysis from basket-late (basel stent kosten-effekivitats trial-late thrombotic events) examined the incidence of clinical events after cessation of clopidogrel therapy. this study identified 746 patients who were without major adverse events 6 months after drug-eluting or bare-metal stent placement. all patients had stopped taking clopidogrel and were followed up for an additional 12 months. at 18-month follow-up, there was no difference between patients with a drug-eluting or bare-metal stent in cumulative rates of death or myocardial infarction (mi). however, after clopidogrel discontinuation patients receiving drug-eluting vs bare-metal stents experienced higher rates of death and mi (4.9% vs 1.3%, respectively). these results have created uncertainty regarding the minimal necessary duration of antiplatelet therapy after drug-eluting stent implantation. also, there remains widespread uncertainty regarding the risk of clinical events after the discontinuation of clopidogrel, particularly after des implantation.

Eligibility criteria:
inclusion criteria: 1. among consecutive patients treated with des, event-free patients who survived at least the first 12 months without nonfatal mi or repeat revascularization 2. the patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site. exclusion criteria: 1. contraindication to antiplatelet therapy (aspirin or clopidogrel) 2. non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment). 3. patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 4. concurrent bleeding diathesis or major bleeding history requiring discontinuation of antiplatelet drugs. 5. patients with left main stem stenosis (\>50% by visual estimate) or left main stenting 6. concomitant disease requiring long-term use of clopidogrel (stroke, peripheral vascular disease, significant carotid a. disease, etc)

Keywords: coronary disease stents antiplatelet drugs drug-eluting stents
heartflow (affects)

Conditions: Cardiovascular Abnormalities

Summary: the overall objective of the affects study is to assess agreement between spect and ffrct in identifying vessel-specific, hemodynamically significant cad in patients scheduled for invasive coronary angiography (ica) based on abnormal spect myocardial perfusion scans. in particular, the study will evaluate the ability of ffrct to correctly rule out hemodynamically significant cad in patients with non-significant cad or normal coronary arteries who had positive spect scans.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * providing written informed consent * subjects with abnormal spect myocardial perfusion imaging results who have been referred for clinically indicated ica within 90-days of spect. * ability to undergo ccta exclusion criteria: * acute coronary syndrome (acs). * prior, clinically documented, myocardial infarction (mi). * prior coronary artery bypass grafting (cabg) * prior coronary stenting * evidence of ongoing or active clinical instability including unstable angina, intractable arrhythmia, cardiogenic shock, unstable bp, and severe chf (nyha class iii or iv) or acute pulmonary edema * contraindications for ccta such as: 1. presence of pacemaker or internal defibrillator leads such that coronary visualization is impaired 2. chronic atrial fibrillation with uncontrolled ventricular response 3. known anaphylactic allergy to iodinated contrast that cannot be pre-medicated 4. pregnancy or unknown pregnancy status in women of childbearing age 5. contraindication to acute beta blockade 6. contraindication to acute sublingual nitrate administration 7. prosthetic heart valve such that coronary visualization is impaired * contraindications for ffrct such as: 1. complex congenital heart disease other than anomalous coronary origins alone 2. ventricular septal defect with known qp/qs \> 1.4 * requiring an emergent procedure within 48 hours of presentation * any active, serious, life-threatening disease with life expectancy less than 2 months * inability to comply with study procedures * current participation in any other clinical trial involving an investigational device, drug, or dictating care pathways at the time of enrollment
long term efficacy and safety of eryfotona ak-nmsc® in patients with actinic keratosis

Conditions: Actinic Keratosis

Summary: the purpose of this study is to assess the efficacy, safety and tolerability of eryfotona ak-nmsc® topical application vs sunscreen on cancerization field of actinic keratosis patients after 6 months of treatment.


Eligibility criteria:
inclusion criteria: 1. current diagnosis of ak, with ≥4 lesions located in the same anatomical district (within a contiguous 50 cm2 area on the face, bold scalp or forehead); 2. female or male \>18 years of age; 3. skin type i or ii according to fitzpatrick; 4. patient has confirmed his/her willingness to participate in this study;. exclusion criteria: 1. topical drug therapy for ak within the past 3 months or for photoaging in the last 6 months, or had lesion-directed therapy within 2 cm2 of the selected ak area during the previous month; 2. suitable for surgical, photodynamic or any other topical treatment in the next 6 months; 3. subjects who suffer/ had suffered from skin cancer or show an early stage of skin cancer or have a genetic predisposition for skin cancer; 4. other skin disease that requires treatment with other medications in the treatment area or in the distance of 3 cm; 5. immunosuppression or current treatment for cancer; 6. clinically unstable medical condition; 7. high risk group for hiv infection or presentation of other infectious diseases 8. presentation of contact allergies or allergies to compounds of the test substances; 9. smoker (more than forty cigarettes per day) or heavy drinker (more than three standard drinks per day); 10. psychiatric disease that may interfere with follow up of study procedures; 11. participation in other clinical trials up to 30 days prior to day 1 of the study 12. prior treatment with study medication in the area to be treated; 13. considered by the investigator, for any other reason, to be an unsuitable candidate for the study.

Keywords: actinic keratosis ak
h&n cancer; survivorship and late effects

Conditions: Head and Neck Neoplasms; Survivorship

Summary: a cross-sectional study on late effects after modern treatment in long-term survivors of head and neck cancer (hnc). participants fill in questionnaires and participate at a one day visit at the hospital including blood sample with biomarkers, clinical examination, audiometry, oral radiological examination and oral examination. data on patients' medical history collected from medical records including radiology images and digital radiotherapy plans.this will allow adjustments of treatment planning and improved treatment decisions for patients at risk, and improve information and follow up for future patients.

the purpose of this study is to provide knowledge on late effects and mortality risk after modern treatment in long-term survivors of head and neck cancer (hnc). this will allow adjustments of treatment planning and improved treatment decisions for patients at risk, and improve information and follow up for future patients. for head and neck cancer (hnc) survivors of today, with the rising proportion of hpv induced cancer and with improved modern treatment, the late effects and mortality risk has changed compared to survivors previous decades. the investigators will assess the prevalence and severity of a broad range of late effects and identify associated risk factors for the following late effects; * chronic fatigue * hearing loss and tinnitus * oral late effects, including taste and smell disturbances and osteoradionecrosis * dysphagia and malnutrition * body image, intimacy and endocrine dysfunction in addition,possible biological explanatory mechanisms for fatigue and possibly other selected late effects will be explored. data will be compared to age and gender matched reference data for those where this is available. design: a cross-sectional study assessments: patient-reported questionnaires, blood sample with biomarkers, clinical examination, audiometry, oral radiological examination and oral examination. data on patients' medical history collected from medical records including radiology images and digital radiotherapy plans.

Eligibility criteria:
inclusion criteria: * histologically or cytologically verified invasive carcinoma of the head and neck region; icd10: c01, c02.0 - c02.9; c03.0 - c03.9; c04.0 - c04.9; c05.0 - c05.9; c06.0 - c06.9; c07; c08.0 - c08.9; c09.0 - c09.9; c10.0 - c10.9; c11.0 - c11.9; c12; c13.0 - c13.9; c14.0 - c14.9; c30; c31.0 - c31.9; c32.0 - c32.9, c77.0 * diagnosed 2006- 2012 * ability to understand and respond to the questionnaires * ability to attend the clinical examination * informed consent received exclusion criteria: * unwillingness to answer hrql questionnaires * patients under ongoing treatment for secondary cancer or relapse at the time of the survey

Keywords: patient reported outcome measure quality of life head and neck cancer
detrusor activity recovery in acute traumatic spinal cord injuries

Conditions: Spinal Cord Injuries; Neurogenic Bladder; Spinal Shock

Summary: determining the most appropriate time to evaluate detrusor activity in urodynamic studies for both traumatic and non-traumatic spinal cord injuries

the detrusor activity in the acute phase of the spinal cord injury changes with the development of the spinal shock. spinal shock is a phase of areflexic phase after the spinal cord injury that is primarily influenced by the severity of the injury and the neurological level of injury. detrusor activity shows areflexic in the spinal shock phase, followed by a return of detrusor activity at the end of the spinal shock. there was no recent study to provide evidence of an appropriate time to assess detrusor muscle activity through urodynamic studies. there were only a few limited studies on detrusor activity following spinal cord injury from 1960 to 1970. however, when the urodynamic study should be performed is still controversial. knowing the patterns of detrusor activity following spinal cord injuries is critical to determining the appropriate timing for intermittent catheterization, which is the standard emptying method of choice. if clinicians fail to understand true detrusor activity as early as possible, the patient will suffer from unnecessary indwelling catheter voiding, resulting in impaired quality of life in the acute phase.

Eligibility criteria:
inclusion criteria: * acute onset suprasacral spinal cord injury with both traumatic and non-traumatic causes within the first 15 days after spinal cord injury(very acute phase of sci according to european multicenter study about sci : the first 15 d (very acute), between 16-40 d (acute i), and 3 mo (acute ii), 6 mo (acute iii), and 12 mo (chronic) after sci) * age older than 18 * inpatient * patients with spinal cord injuries who initially keep the indwelling catheter * patients with or without spinal shock exclusion criteria: nstable vital sign (using inotropics or vasopressors or antiarrhythmic agents) * current urinary tract infection * agitated behavior (richmond agitation and sedation scale of +2 to +4) * decreased mentality (rass of -2 to -5) * concomitant sacral lesions (ex. sacral fracture, pelvic bone fracture, urologic trauma) * concomitant supraspinal lesions (ex. traumatic brain injury, old stroke, parkinson disease) * uncontrolled dm * medical history of lower urinary tract dysfunction (ex. bph, malignancy) * uncontrlled autonomic dysreflexia (in case of autonomic dysreflexia, defined according to isafsci (international standards to document remaining autonomic function after sci) as an increase in systolic blood pressure 20 mm hg or greater from baseline
a new measure of body image in eating disorders

Conditions: Eating Disorder

Summary: this study aims to compare a new electronic instrument called (here referred to as the 'body app') with traditional paper and pencil rating scales for assessing how individuals with eating disorders evaluate their body image.

self-perceived weight or shape disturbance is a core symptom of eating disorders, with heavy therapeutic and prognostic relevance. developing a reliable and unbiased method to assess body image disturbance is imperative, as feature characteristics of eating disorders, such as anorexia nervosa, include the overestimation of body size and shape. among the most essential features of the disorder, this inability to correctly judge one's own body image has been frequently linked to the maintenance of eating disorders. moreover, persistent perceptual disturbance for one's visual appearance is one of the strong predictors of relapse in an and bulimia nervosa. body image disturbance can be conceptualized as having two main components: perceptual, and attitudinal/affective. these might be considered two distinct constructs, best measured independently. however, clinicians currently rely upon self-report questionnaires that evaluate aggregates of symptoms, perceptual experiences, behaviors, and thoughts linked to the disorder. some scales selectively evaluate body image characteristics such as body dissatisfaction and body distortion. however, it is unclear to what degree each of these measures quantifies the specific components of perceptual experiences vs. attitudinal/affective aspects. this study aims to evaluate whether a new electronic instrument, here referred to as the 'body app', which separates estimations of body shape and size from the attitudinal/affective component might result in closer approximations of the perceptual component of weight or shape disturbance, and facilitate the assessment of body image disturbance in eating disorders.

Eligibility criteria:
eating disorders group: inclusion criteria: * primary clinical diagnosis of eating disorder * receiving inpatient treatment for eating disorder * body mass index greater than or equal to 14 * independently ambulatory * possession of a smartphone with data plan * english proficiency exclusion criteria: * active suicidal ideation * comorbid schizophrenia spectrum or other psychotic disorder. healthy comparison group: inclusion criteria: * no current psychiatric diagnosis * body mass index greater than or equal to 14 * independently ambulatory * possession of a smartphone with data plan * english proficiency exclusion criteria: * body mass index \> 41 * active suicidal ideation

Keywords: body image
a study to assess the disease control of moderate to severe atopic dermatitis in male and female participants of atleast 12 years old receiving dupilumab injections in gulf countries

Conditions: Dermatitis Atopic

Summary: primary objective: to assess the disease control of moderate to severe atopic dermatitis in patients aged 12 years and above treated with dupilumab therapy using atopic dermatitis control tool (adct) after 24 weeks of treatment. secondary objectives: * to figure the proportion of patients with reduction of adct score by 5 points after 4, 12, and 24 weeks of treatment. * to figure the proportion of patients with adct score less than 7 at weeks 4, 12, and 24. * assess the effectiveness of dupilumab in moderate to severe atopic dermatitis (ad) patients, using the severity score as routine practice scoring atopic dermatitis (scorad). * to describe comorbidities related to type 2 inflammation. * to characterize the safety profile of dupilumab in the local gulf population. * to evaluate treatment satisfaction in the local gulf population.

24 weeks

Eligibility criteria:
inclusion criteria: * having moderate to severe atopic dermatitis: * moderate atopic dermatitis is defined at screening and baseline as i) atopic dermatitis body surface area (bsa) involvement ≥10%; and ii) pruritus numerical rating scale (nrs) ≥3, eczema area and severity index (easi) score ≥16 at screening and baseline, investigator's global assessment (iga)=3, or scoring atopic dermatitis (scorad) is between 25 and 50. * severe atopic dermatitis is defined at screening and baseline as i) atopic dermatitis bsa involvement ≥10%; ii) eczema area and severity index (easi) score ≥20; iii) investigator's global assessment (iga) score = 4, or scorad ≥50. * initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation. * participants and/or his legally approved representatives (lar, in case of minor subject) agrees to sign an informed consent or an assent. * age of 12 years or above. exclusion criteria: * participation in another trial. * pregnancy or lactating or planning/intending to be pregnant in the next 6 months. * presence of active chronic or acute infection requiring systemic treatment * diagnosed active endoparasites infection, or suspected high risk of infection. * human immunodeficiency virus (hiv), hepatitis b or c, malignancy, or other concomitant illnesses. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
a randomized controlled trial of auricular acupressure in treating estazolam-dependent insomnia

Conditions: Estazolam-dependent Insomnia

Summary: insomnia is a disorder characterized by difficulties in falling asleep, maintaining sleep or waking up too early, and impairment of daytime functioning. drug-dependent insomnia refers to insomnia patients taking sedatives and sleeping pills regularly for a long period of time, and becoming psychologically and physiologically dependent on them. in many countries, auricular acupressure (aa) has attracted growing attention as a complementary or alternative treatment for insomnia; however, there is a lack of rigorous randomized, controlled studies evaluating aa specifically for estazolam-dependent insomnia. our proposed trial aims to assess the therapeutic effect of aa on estazolam-dependent insomnia.

this study is a randomized, single-blinded, three-arm controlled trial. no less than 120 participants will be randomized into one of three groups: aa group, sham auricular acupressure (saa) group, and conventional dosage reduction group. all treatments will be administered for 4 weeks, with a follow-up period of 1 month. the primary clinical outcomes will be estazolam dosing and reduction rates, serum gamma-aminobutyric acid (gaba) and cortisol (cort) levels. secondary outcomes will concern the pittsburgh sleep quality index (psqi) and benzodiazepine withdrawal symptom questionnaire (bwsq). both intention-to-treat and per-protocol analyses will be performed, with significance level determined as 5%.

Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria for insomnia; * meet the diagnostic criteria for hypnotic drug-dependent insomnia; * regularly taking estazolam tablets for more than 2 months, and need to stop the medication; * the dependent dosage of estazolam is 1mg, and withdrawal reaction occurs when the dosage is less than 1mg; * psqi score ≥ 7 (defined as "poor sleep quality", psqi ≥ 7 is used as the reference threshold for judging sleep quality problems); * sign the informed consent. exclusion criteria: * patients with cognitive disorders caused by cerebrovascular diseases, psychiatric disorders, and so on; * patients with serious heart, liver, kidney and blood system diseases; * patients with psychiatric illness/drug abuse (including alcohol); * patients who cannot cooperate with treatment, observation and evaluation.

Keywords: auricular acupressure estazolam insomnia drug-dependent estazolam-dependent insomnia randomized controlled trial
an observational study on long-term efficacy and safety of roactemra/actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis (fact)

Conditions: Rheumatoid Arthritis

Summary: this observational study will evaluate the long-term efficacy and safety of roactemra/actemra (tocilizumab in participants of the act sure clinical trial and further patients with moderate to severe rheumatoid arthritis starting or receiving roactemra/actemra. data will be collected from each patient for up to 4 years.


Eligibility criteria:
inclusion criteria: * adult patients, \>18 years of age * participants in the act-sure trial, or patients with moderate to severe rheumatoid arthritis starting or receiving roactemra/actemra exclusion criteria: * contra-indications for roactemra/actemra
study of cases of serious infections due to carbapenem-resistant enterobacteriaceae

Conditions: Urinary Tract Infection, Complicated; Acute Pyelonephritis; Hospital Acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia; Bacteremia

Summary: a multi-center, retrospective study of cases of serious bacterial infections including complicated urinary tract infection (cuti) or acute pyelonephritis (ap), hospital acquired bacterial pneumonia (habp), ventilator acquired bacterial pneumonia (vabp), and/or bacteremia caused by carbapenem-resistant enterobacteriaceae (cre)

this multi-center, retrospective study of cases of serious bacterial infections (including cuti or ap, habp, vabp, and/or bacteremia caused by cre) will consist of a chart review over a 6 month period from september 1, 2013 to march 1, 2014. de-identified data will be collected from the chart review of at least 150 cases of selected infections due to cre at approximately 20 sites. the study itself is strictly observational and retrospective, with no direct study-related patient interaction, treatment, or testing. there will be no patient identifying data collected as part of this study. charts of patients who meet study-defined criteria for cuti or ap, habp, vabp, and/or bacteremia and have a culture from the site of infection or the blood that is positive for a carbapenem-resistant enterobacteriaceae will be reviewed.

Eligibility criteria:
inclusion criteria: * male or female ≥18 years of age. * carbapenem resistant enterobacteriaceae (cre) must be identified in the urine, blood or respiratory tract samples submitted for culture in the setting of cuti or ap, habp, vabp, and/or bacteremia. * diagnosis with either cuti or ap, habp, vabp, and/or bacteremia. exclusion criteria: * none