Kornimate/medical-research-clean huggingface dataset:
post marketing surveillance of roflumilast in korea

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of roflumilast in the real-use conditions with its registered indications.

the drug being tested in this study is called roflumilast. roflumilast is used to treat people who have severe chronic obstructive pulmonary disease (copd) forced expiratory volume in 1 second (fev1) post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of worsening symptoms. this study will look at side effects and the lung function of people who take roflumilast. the study will enroll approximately 3000 patients who plan to take roflumilast as an add on to bronchiodilator treatment by their healthcare provider. this multi-centre trial will be conducted in korea.. the administration period of the roflumilast is determined in accordance with actual treatment policy for the subject, subjects will be evaluated during routine appointments with their healthcare provider. this multi-centre trial will be conducted in korea. the overall time to participate in this study is up to 1 month. participants will be evaluated during routine appointments with their healthcare provider.

Eligibility criteria:
inclusion criteria: * 1. has signed the 'informed consent form' prior to use-result surveillance enrollment. 2. has severe chronic obstructive pulmonary disease (copd) (fev1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of exacerbations. 3. plans to take roflumilast as add on to bronchodilator treatment. 4. has not participated in the study before. exclusion criteria: * 1. is hypersensitive to the principal components and additives of this product . 2. suffers from moderate or severe liver diseases (child-pugh class b or c). 3. suffers from severe immune system disorders (e.g., human immunodeficiency virus (hiv) infection, multiple sclerosis, systemic lupus erythematosus, progressive multifocal leukoencephalopathy etc.). 4. suffers from severe acute infectious diseases. 5. suffers from cancer(excluding basal cell carcinoma). 6. is administered immunosuppressants (e.g.: methotrexate, azathioprine, infliximab, etanercept or long-term use of oral corticosteroids); however short-term use of systemic corticosteroids is excluded. 7. suffers from latent infections (e.g., tuberculosis, viral hepatitis, herpes virus infections, herpes zoster and etc.). 8. suffers from congestive heart failure (new york heart association (nyha) class iii or iv). 9. has a history of depression with suicidal thoughts or behaviors. 10. has genetic problems such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption, since this drug contains lactose.

Keywords: drug therapy
the relationship between heart function and metabolism in hfpef patients

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: hfpef has gradually become the most common form of heart failure. studies have found that metabolic abnormalities and chronic inflammation ultimately lead to hfpef by promoting heart remodeling. however, there are few relevant studies and the mechanism is still unclear.

however, heart failure with preserved ejection fraction is difficult to diagnose and treat due to its unknown pathogenesis and poor prognosis. ventricular diastolic dysfunction and retention of left ventricular ejection fraction are important pathological features of heart failure with preserved ejection fraction. currently, it is widely believed to be a clinical syndrome associated with old age, women, obesity, diabetes, hypertension, atrial fibrillation, coronary heart disease, atherosclerosis, etc. however, the specific mechanism of heart failure with preserved ejection fraction caused by the above-mentioned complications is unknown. in conclusion, the investigators intend to explore the pathogenesis of heart failure with preserved ejection fraction by observing the changes of heart and body metabolism in patients with heart failure with preserved ejection fraction, and provide a basis for the diagnosis and treatment.

Eligibility criteria:
inclusion criteria: * adult aged ≥ 18 years old * patients diagnosed with hfpef; diagnostic criteria including: 1. lvef 50% or higher; 2. bnp≥35 pg/ml and/or ntprobnp≥125 pg/ml; 3. presence of symptoms and/or signs of heart failure; 4. at least one additional criteria: relevant structure heart disease or diastolic dysfunction exclusion criteria: * severe liver failure; * other causes of shortness of breath, such as severe pulmonary disease or severe ● chronic obstructive pulmonary disease; * primary pulmonary hypertension. * severe left valvular heart disease. * long-term bedridden or unable to move autonomously * age \< 18
eyelid position interdependence in involutional ptosis patients submitted to 10% phenylephrine

Conditions: Blepharoptosis

Summary: the primary aim of this study is to quantify eyelid position changes in tested and opposite eyes in ptosis patients submitted to 1, 2 or 4 drops of 10% phenylephrine in one eye. the secondary objective is to correlate the eye dominance, severity and laterality of ptosis with eyelid position changes in these 3 groups.

this is a prospective observational study conducted in involutional ptosis patients, which will be submitted to instillation of a single drop of 10% phenylephrine in one eye(group 1), 2 drops (g2) or 4 drops ( g3). video camera will record the images of both eyes before and after drug application at 3, 10, 15 and 30 minutes. the images will be edited to analyze upper and lower lid height.

Eligibility criteria:
inclusion criteria: * involutional blepharoptosis * upper margin-reflex distance less or equal 2.0mm * good fixation and collaboration exclusion criteria: * previous eyelid surgeries * use of adrenergic or sympathicomimetics drugs * myopathies * thyroid orbitopathy * non-controlled cardiovascular disease

Keywords: adrenergic alpha-agonists phenylephrine drug effects diagnostic use
botox® efficacy and safety in the treatment of knee osteoarthritis

Conditions: Osteoarthritis

Summary: this study will evaluate the efficacy and safety of a single intra-articular injection of 2 doses of botox® (onabotulinumtoxina) compared with placebo as treatment for knee osteoarthritis symptoms.


Eligibility criteria:
inclusion criteria: * painful osteoarthritis * able to discontinue anti-inflammatory drugs and analgesics * must be ambulatory without assistive walking devices exclusion criteria: * chronic pain conditions other than knee osteoarthritis * treatment with corticosteroids in the study knee within 12 weeks * treatment with hyaluronic acid in the study knee within 24 weeks * previous treatment with any botulinum toxin for any reason * diagnosis of myasthenia gravis, eaton-lambert syndrome, or amyotrophic lateral sclerosis
effectiveness of reduced gcsf dosing in patients with a low to moderate risk of febrile neutropenia

Conditions: Breast Cancer

Summary: the study aims to confirm that a reduced dosage of gcsf is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.


Eligibility criteria:
inclusion criteria: breast cancer chemotherapy administration (new line) chemotherapy type : fec, ec, ac, docetaxel containing regimen chemotherapy setting : adjuvant or neoadjuvant exclusion criteria: eligibility to receive reimbursed gcsf

Keywords: gcsf chemotherapy breast cancer prophylaxis
positive psychology for smoking cessation

Conditions: Mental Illness; Tobacco Dependence

Summary: this study will examine how positive psychotherapy (ppt) may help people interested in quitting smoking, quit.

this project aims to adapt the positive psychotherapy (ppt) practice for smoking cessation in adults with severe mental illness (smi), testing its usability, feasibility, and acceptability in a mixed-methods feasibility pilot study. qualitative interviews will be conducted to obtain usability and acceptability input on the adapted ppt manual from 4-5 peer providers. then, in partnership with the mental health center of greater manchester (mhcgm), 6-8 adult smokers with smi will be recruited who want to quit smoking in the next month and are willing to use nicotine replacement therapy (nrt). the 16-week ppt adaptation ("positive recovery for smoking") will be tested progress on cessation assessed through interviewer-administered quantitative assessments at baseline, 8, and 16 weeks. self-reported cigarettes per day (cpd) and carbon monoxide (co) will be collected prior to each group treatment session. informed by the weekly group check-in of cessation progress (quitting status), qualitative interviews will be conducted at 16 weeks to obtain a more nuanced description of the uptake of the intervention, successful quitting strategies, and barriers to cessation with this new method. the manual and materials will be adapted based on the feedback from the first group and another group of 6-8 participants will be recruited to receive the refined intervention and protocol. the result of this feasibility pilot will provide data on the adapted ppt's feasibility and acceptability, alongside a deep description of strategies used and why and how the treatment was perceived as useful or not to the enrolled participants.

Eligibility criteria:
inclusion criteria: * age 21+; * serious mental illness (smi) diagnosis; * smoking ≥10 cpd; * breath co ≥10; * desire to quit in the next month; * willingness to use nrt daily; * english speaking and literate to engage in the treatment. exclusion criteria: * legal guardian; * active substance use disorder.
contrast-enhanced ultrasound diagnosis of acute appendicitis

Conditions: Appendicitis Acute

Summary: this study evaluates the ability of contrast-enhanced ultrasound to improve the diagnosis of acute appendicitis in children compared to conventional ultrasound.

acute appendicitis is the most common surgical emergency in children. diagnostic evaluation for possible appendicitis frequently leads to imaging studies. magnetic resonance imaging (mri) and computed tomography (ct) are currently the gold-standard techniques for the diagnosis or exclusion of acute appendicitis. however, these methods not always immediately available; may require administration of intravenous contrast material with the potential for allergic reactions and nephrotoxicity; and, in the case of ct, requires the administration of ionizing radiation that is linked to the long-term development of radiation-induced cancers. the current study will evaluate a potentially safer, radiation-free diagnostic method for acute appendicitis, using contrast-enhanced ultrasound to provide a more accurate means of visualizing the appendix than conventional us imaging.

Eligibility criteria:
inclusion criteria: * children who have had a conventional abdominal us study to rule out acute appendicitis and are scheduled for an mri or ct examination. exclusion criteria: * children with serious comorbid conditions, including but not restricted to severe cardiac, pulmonary, renal, or hepatic disease; prior bone marrow or solid organ transplant; cancer; or presence of a ventriculoperitoneal shunt. * children with an allergy to either the active or inactive components of lumason. * pregnant or nursing patients.
optimization of spontaneous postoperative trial of void among women

Conditions: Urinary Retention Postoperative; Voiding Disorders

Summary: trial of void (tov) is a diagnostic test performed on all women who undergo prolapse repair or incontinence surgery, due to the importance of diagnosing postoperative urinary retention (pour). incidence of pour may be as high as 62% in some studies. timely and accurate diagnosis is important to avoid complications such as urinary tract infection, bladder overdistension, and permanent bladder injury. despite the frequent use of tov, there is no gold standard for the test, and it likely has poor specificity, leading to discharge of more patients with catheter than required. this prospective cohort study will seek to establish evidence-based optimal parameters for spontaneous trial of void, a tov modality that has merit for further evaluation given lower theoretical risk of urinary tract infection.

patients will learn to perform self-catheterization ('clean intermittent catheterization', or cic) preoperatively; after surgery, the investigators will collect a range of voiding parameters used during different tov protocols (including minimum voided volume \[mvv\], post-void residual via bladder scanner \[pvr\], subjective force of urinary stream \[sfos\]). patients will discharge home to perform cic until two sequential post-void residuals of less than half the volume voided have been achieved. the rate of voiding dysfunction and resulting pvrs will be used to compare the diagnostic accuracy of the perioperative voiding parameters to predict need to perform cic and post-operative urinary retention.

Eligibility criteria:
inclusion criteria: * english-speaking women, age \>18yo * scheduled for urogynecology procedure which will need post-operative trial of void (including pelvic organ prolapse and/or stress urinary incontinence repair), with plan for same-day discharge. exclusion criteria: * unable or unwilling to perform self-catheterizatoin either by patient or willing family member * pre-existing voiding dysfunction defined as documented pvr \> 200 ml * intraoperative urinary tract injury needing indwelling catheter on discharge * need for overnight admission

Keywords: urogynecologic surgery urinary retention postoperative
clinical trial of abdominal breathing for urinary retention after spinal cord injury

Conditions: Spinal Cord Injuries (SCI); Urinary Retention

Summary: randomized controlled trials were conducted in patients with urinary retention after spinal cord injury. the effects of abdominal breathing training on pelvic floor muscle tone, muscle strength and residual urine volume in patients with urinary retention after spinal cord injury were observed by glazer and bladder volume measurement to compare the electromyography value and residual urine volume of pelvic floor muscles at different stages of resting state and contraction state of the two groups, and the subjective feelings of the patients were evaluated in combination with relevant scales. to provide a scientific basis for abdominal breathing as an adjuvant treatment for urinary retention after spinal cord injury.


Eligibility criteria:
inclusion criteria:(1) meet the "international standards for the neurological classification of spinal cord injuries" formulated by the american spinal cord injury association, and after the end of the spinal cord shock period, the asia classification is b, c, and d, and the clinical manifestations are urinary retention, residual urine \> 100ml, and gender is not limited; (2) age 16-80 years old; (3) the course of the disease is within 12 months; (4) intermittent catheterization; (5) pelvic floor muscle function test shows pelvic floor muscle hypotonia; (6) have good communication skills, voluntarily participate in the trial and sign the informed consent form. - exclusion criteria: (1) patients with severe urinary tract infection and hydronephrosis; (2) those with other serious diseases; (3) respiratory failure or tracheostomy; (4) patients with urinary retention not caused by spinal cord injury; (5) dermato-electrode passers; (6) patients with consciousness impairment and cognitive impairment; (7) patients with poor treatment compliance and inability to follow doctor's instructions. -
hand10 questionnaire in individuals with carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: hand10 questionnaire, boston carpal tunnel syndrome questionnaire and arm shoulder questionnaire for patients with carpal tunnel syndrome and hand deficiencies questionnaire (dash) will be applied one week apart to investigate the validity of the questionnaire. test-retest reliability and internal consistency will be determined using intraclass correlation coefficient analysis and cronbach alpha, respectively. the validity of hand10 in individuals with cst will be determined using the pearson correlation coefficient analysis, the arm, shoulder, and hand disability questionnaire and the boston carpal tunnel syndrome questionnaire.


Eligibility criteria:
inclusion criteria: * patients who volunteer for treatment * 18-70 years old patients * with patients diagnosed with cts exclusion criteria: -patients who have had surgery on the wrist area

Keywords: carpal tunnel syndrome dash questionnaire boston carpal tunnel syndrome questionnaire hand10 questionnaire validity and reliability
efficacy study of autosuggestion for quality of life of geriatric patients

Conditions: Quality of Life for Geriatric Patients.

Summary: the objective is to analyze the efficacy of autosuggestion for geriatric patients's quality of life and its impact to psycho-neuro-endocrine-immune pathways. the primary outcome is quality of life. the hypothesis of this study is that autosuggestion will increase geriatric patient's quality of life based on its impact to psycho-neuro-endocrine-immune pathways.

geriatric patients diagnosed with multipathology after getting information and signing informed consent will be included in this trial. autosuggestion was created by patients according to their preferences, modified by researcher to accomplish autosuggestion principles, recorded in a tape to be heard by walkman daily for 30 days. intervention and control groups received usual standard medical therapy. baseline data were collected within one week after admission. then the subject will be followed up for 30 days. primary outcome was quality of life measured by coop chart, analyze using on treatment analysis. secondary outcomes were serum cortisol, interleukin-2, interleukin-6, ifn-ϒ (interferon gamma), and n acetyl aspartat/ creatine ratio in limbic and paralimbic system by magnetic resonance spectroscopy.

Eligibility criteria:
inclusion criteria: * age: ≥ 60 years old with multipathology, inpatients * not in steroid therapy * could communicate (karnofsky score: 40% or zubrod/who score: 3) * cooperative * willing to go through all of the research steps. exclusion criteria: * stroke * multiple sclerosis * brain tumour * using pace maker

Keywords: autosuggestion quality of life geriatric serum cortisol interferon gamma interleukin-2 interleukin-6 neuroplasticity
binges and neural variability

Conditions: Binge-Eating Disorder

Summary: people who suffer from binge eating disorder experience recurrent episodes of binge eating.during these episodes, they consume an unusually large amount of food in a short amount of time and experience loss of control over eating. however, why such binge eating episodes occur is still largely unknown. this makes it difficult to develop targeted treatments. in this project, the experimenters are investigating the brain mechanisms that give rise to the disorder. they hypothesize that the binge eating episodes are due to an increased variability in reward processing, which they will assess repeatedly over days. they will test this hypothesis using mathematical models based on behavioural and mri measurements that are related to the processing of rewards.


Eligibility criteria:
inclusion criteria: * binge eating disorder diagnosis * subsyndromal binge eating (control) exclusion criteria: * high risk of suicide * co-occurring psychotic, bi-polar disorders, alcohol/substance dependence within the past six months * lack of capacity for consent * medical disorders that would affect weight and ability to participate * insufficient german language skills (assessment will be in german) * taking medication that would affect weight * mri exclusion criteria * irremovable metal attached to the body (e.g. piercings) * irremovable medical devices (e.g. pacemakers) * any trauma or surgery which may have left ferromagnetic material in the body * large tattoos * pregnancy * claustrophobia

Keywords: reward sensitivity neuroimaging variability ecological momentary assessment (ema)
presentation of lumbar disc and reduction of symptoms

Conditions: Radiculopathy

Summary: the trial aims to assess the hypothesis that presentation of the disc material to the patient following a lumbar microdiscectomy would positively influence the improvement in their leg and back symptoms.

objective. the trial aims to assess the hypothesis that presentation of removed material to the patient following a lumbar microdiscectomy would positively influence the improvement in their radiculopathic and degenerative symptoms. design. data will be collected prospectively. patient allocation to treatment groups will be by simple randomization using a computer generated sequence of random numbers. trial participants will be blinded as to the trial hypothesis and investigators blinded to patient allocation. setting. patients will all be treated in a single secondary care unit. participants. all adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc over a six month period will be considered for entry into the trial. exclusion criteria: inability to give verbal consent, age less than 18, previous spinal surgery, emergency discectomies, patients having spinal fusions and those with no radiculopathic symptoms. intervention. patients allocated to the experimental arm will be given the removed disc fragments to keep once they have recovered from anaesthesia. those in the control arm will not be shown disc fragments (best available treatment). main outcome measure. the degree of improvement in radiculopathic and degenerative symptoms reported by the patient at 2-3 months after surgery.

Eligibility criteria:
inclusion criteria: * all adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc exclusion criteria: * inability to give verbal consent, age less than 18, previous spinal surgery, emergency discectomies, patients having spinal fusions and those with no radiculopathic symptoms.

Keywords: intervertebral disc lumbar discectomy outcome radiculopathy due to prolapsed intervertebral disc.
safety and efficacy of cyclosporine ophthalmic emulsion in patients with primary pterygium

Conditions: Pterygium

Summary: this study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion 0.05% (restasis®) in patients with primary pterygium (abnormal growth on surface of eye).


Eligibility criteria:
inclusion criteria: * have a pterygium in at least one eye that has not been previously removed with surgery exclusion criteria: * uncontrolled systemic disease * active eye disease * current or anticipated use of topical eye medications other than artificial tears. * anticipated wearing of contact lenses