Kornimate/medical-research-clean huggingface dataset:
long-term treatment study of mra for polyarticular juvenile idiopathic arthritis (pjia)

Conditions: Polyarticular Juvenile Idiopathic Arthritis

Summary: this is an open-label, extension, phase iii study to evaluate the long-term safety, efficacy and pk of mra in patients with pjia who participated in study mra318jp.


Eligibility criteria:
inclusion criteria * of the patients who received three infusions with mra in the previous study and for whom a last observation was conducted * the patients who did not have problems with safety in the previous study" exclusion criteria * patients who were not enrolled by 3 months after completion of the previous study * patients who received any of the following since completion of the previous study until initiation of treatment in the present study 1. dmards or immunosuppressants 2. intravenous and intramuscular injection of corticosteroids 3. plasma exchange therapy 4. other drugs and therapies that may affect evaluation of drug efficacy
ph2a study to evaluate iw-3718 in patients with gastroesophageal reflux not completely responsive to proton pump inhibitors

Conditions: Gastroesophageal Reflux

Summary: this study is meant to assess the effect of iw-3718 as an added treatment to ongoing once-daily protocol pump inhibitor (ppi) treatment for patients who continue to experience symptoms of their gastroesophageal reflux disease (gerd).


Eligibility criteria:
inclusion criteria: * patient is between 18 and 65 years of age at the screening visit; females must not be pregnant or must not be breastfeeding; * patient has a confirmed diagnosis of gastroesophageal reflux disease, must be currently taking a proton pump inhibitor (ppi), and must be experiencing gerd symptoms as specified by the protocol. exclusion criteria: * patient may not meet any of the excluded conditions specified in the protocol; * patient is experiencing alarm symptoms such as gi bleeding, anemia, vomiting, dysphagia, or unexpected weight loss; * patient has a clinically significant hypersensitivity or allergies to any of the active ingredients or excipients in the study medication.
co2 laser vs lidocaine for vestibulodynia in premenopausal women

Conditions: Vulvodynia

Summary: co2 laser energy is currently used widely for the treatment of postmenopausal women who have vaginal atrophy due to the lack of estrogen. however, its effect on premenopausal women with hormonally-mediated vulvar vestibulodynia is unknown. this study seeks to evaluate the effect of co2 laser on young women and compare it to topical lidocaine.

the purpose of this study is to see if vaginal laser therapy with monalisa touch® will be more effective in treating vestibulodynia than current treatment with a topical lidocaine ointment. vestibulodynia is a common bothersome condition and is more likely to occur in women on hormonal contraceptive treatment. to date, there are no effective treatments that address the underlying causes of the disease. monalisa touch® is a laser procedure that delivers co2 laser energy to the vaginal wall tissue. this energy causes the patient's own body to regenerate collagen and blood vessels, changing the tissue to make it healthier. the monalisa touch® technology may help vestibulodynia by potentially fixing the underlying cause. this may be more effective than using the topical lidocaine which makes the tissue numb.

Eligibility criteria:
inclusion criteria: * age 18 years to 40 years * hormonal contraceptive therapy for at least one year consecutive duration * vestibulodynia diagnosis meeting the following criteria: * localized vulvar pain to vaginal vestibule * at least 3 months duration * without clear identifiable cause exclusion criteria: * suspected primary cause to vestibular pain that warrants directed treatment * history of chronic infection or autoimmune disease * prior pelvic surgery including mesh placement for incontinence or prolapse, vestibulectomy, vulvectomy, or labiaplasty * active vulvar or vaginal infection * allergy or contraindication to topical lidocaine treatment * prior diagnosis or treatment of vulvar intraepithelial neoplasia or vulvar malignancy
a registry study on hospitalized patients with community-acquired pneumonia in real-life of china

Conditions: Community Acquired Pneumonia

Summary: the purpose of this study is to evaluate the disease burden of hospitalized patients with cap and hcap in real life of china

in china, the data about current management of patients hospitalized with community acquired pneumonia (cap) in the real-life setting is not available,type of pneumonia, selection of initial antibiotic, time to clinical stability, antibiotic choice anf modification,clinical outcomes and costs remain unclear. in this study, we will collect comprehensive information on cap and healthcare associated pneumonia (hcap) management patterns to evaluate the disease burden of hospitalized patients with cap and hcap in real life of china .to analyze microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of patients with cap (\> and = 65 years, different comorbidities ,risk factors) ,to investigate microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of disease severity with cap ,to provide the difference on microbiological characteristics,clinical manifestations,antibiotic regimens ,and outcome between patients with cap and hcap ,to understand the current situation of antibiotic regimen ,to evaluate influence of different antibiotic regimens on prognosis.

Eligibility criteria:
inclusion criteria: * patients \> or = 14 years of age * patient meets the criteria of community acquired pneumonia * patient meets the criteria of healthcare-associated pneumonia * informed consent to participate in the study is provided exclusion criteria: * patients participating in a clinical trial or other intervention studies * patients \<14 years of age * patient meets the criteria of hospital acquired pneumonia * known active tuberculosis or current treatment for tuberculosis * non-infectious pulmonary diseases （e.g. pulmonary embolism, pulmonary edema, pulmonary vasculitis, interstitial pneumonia） * hiv positive

Keywords: community acquired pneumonia healthcare associated pneumonia
chinese atrial fibrillation registry

Conditions: Atrial Fibrillation (AF)

Summary: this prospective, observational cohort study aims to establish a long-term registry of adult patients with atrial fibrillation (af) in china to comprehensively characterize patient profiles and evaluate real-world management and outcomes over time. the objectives of the study are to: * describe the demographic, clinical, and treatment characteristics of af patients across different stages of disease progression. * assess the effectiveness and safety of various af treatment strategies, including oral anticoagulation, catheter ablation, and left atrial appendage closure, in routine clinical practice. * identify patient- and treatment-related factors that influence therapeutic outcomes. * explore the role of advanced technologies and artificial intelligence in improving procedural performance, risk stratification, and clinical decision-making in af care. participants will undergo standardized baseline evaluation and longitudinal follow-up to collect data on heart rhythm monitoring, treatment exposures, healthcare utilization, clinical events, and patient-reported outcomes. this cohort will generate real-world evidence to inform personalized and evidence-based management of af.

this prospective, multicenter observational registry aims to collect standardized clinical data on adults with atrial fibrillation (af) across over 30 hospitals in china. the study reflects real-world clinical practice and does not interfere with treatment decisions. baseline and follow-up data will be collected using standardized forms, including demographics, medical history, cardiovascular risk factors, laboratory and imaging results, medication use, and-when applicable-procedural details for catheter ablation, such as energy source and complications. follow-up will be conducted at 1, 2, 3, and 6 months after enrollment, and every 6 months thereafter. data include ecg monitoring, medication updates, hospitalizations, adverse events (e.g., stroke, bleeding, cardiovascular death), and healthcare utilization. quality of life, cognitive, and psychological assessments may also be collected. all treatments are determined by physicians as part of usual care. the registry provides internal feedback on potential treatment issues and generates periodic, anonymized summaries for participating centers. the study aims to inform clinical practice and support real-world evidence generation to improve af management in china.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. documented atrial fibrillation episode lasting \>30 seconds confirmed by electrocardiogram (ecg), holter monitor, implantable cardiac monitor, or wearable ecg device 3. signed informed consent and willingness to participate in follow-up exclusion criteria: 1. atrial fibrillation due to a reversible cause (e.g., transient secondary af) 2. presence of comorbid conditions associated with an expected life expectancy of less than 1 year
pharmacology and non-pharmacology approaches in reducing children's pain and fear during painful procedures

Conditions: Pain

Summary: this study will contribute in the knowledge of pediatric nurses during painful procedures such venipuncture

children frequently undergo unexpected and procedure-related pain while in hospital settings, leading to adverse emotional and psychological effects. the exposure to painful procedures, particularly venipuncture, commonly occurs in emergency units, upon admission, during hospital stays, or during follow-up visits. the mere act of inserting needles stands out as one of the most distressing medical procedures for children, resulting in frightening and upsetting experiences for both the children and their parents throughout the hospitalization period. in the realm of pain management, interventions can generally be classified into pharmacological and non-pharmacological approaches. within pharmacological interventions, local anesthetics play a key role in addressing needle-related pain. these anesthetics can permeate the cuticle and epidermal layers of intact skin, reaching the dermis where nerve endings are situated, thereby alleviating pain. notably, a eutectic mixture of local anesthetics (emla) emulsion, composed of 25 mg lidocaine and 25 mg prilocaine per gram, has been explored in pediatric settings for managing venipuncture pain due to its effectiveness and minimally invasive nature. on the non-pharmacological front, various strategies have been investigated for needle procedures in children, including distraction techniques, cognitive and behavioral therapy, hypnosis, and memory alteration. among these interventions, distraction stands out as a straightforward method that can be promptly applied and requires minimal prior training. a systematic review has demonstrated the effectiveness of distraction in alleviating pain associated with needle-related procedures.

Eligibility criteria:
inclusion: school-aged 6-12 years old. children who require pivc. exclusion: 1. chronic diseases, 2. physical impairment, 3. disability contributes to difficult communication, 4. children of unsatisfied parents, 5. children with neurodevelopment delays, 6. cognitive impairment, hearing impairment, or visual impairment, 7. taking an analgesic within 6 hours, or those with a syncope history.

Keywords: pain, anxiety, painful procedures
efficacy study of azithromycin-based therapy for bronchiolitis obliterans

Conditions: Graft vs Host Disease; Bronchiolitis Obliterans

Summary: \[study objectives\] * to evaluate the efficacy of azithromycin, n-acetylcystein, and inhaled corticosteroid combination therapy in patients with bronchiolitis obliterans as a complication of allogeneic hematopoietic cell transplantation in terms of response rate at 6 months after treatment initiation based on the improvement of fev1.

* bronchiolitis obliterans (bo) is a graft-versus-host disease of respiratory organs. * prognosis of bo is very poor, and the overall outcome of patients who are involved in bo is very dismal. * the mechanism of bo has been known to be associated with immune / non-immune response. * corticosteroid and immunosuppressants are recommended as a best current treatment options for bo, which have been not satisfactory. * many treatment options have been tried to improve the outcome of bo. * azithromycin, as an immune modulating agent, has been tried for the treatment of bo, and has been reported to show hopeful results. * n-acetylcystein, as an antioxidative agent, has been tried for bo. * inhaled corticosteroid may help to improve airway inflammation and decrease the amount of systemic corticosteroid. * these 3 drugs are widely used for other respiratory disease, have been proven to be safe, and have shown some efficacy for bo in various depth of evidence. * in these rationale, we'd like to try the 3-drug combination for bo, to assess the efficacy and safety of these drug combination.

Eligibility criteria:
inclusion criteria: * patients who previously received allogeneic hematopoietic cell transplantation due to hematologic malignancy, bone marrow failure syndrome, and other compatible disease. * patients who are diagnosed as bronchiolitis obliterans (bo) according to the nih diagnostic guideline which is suggested as below. * patients should be 15 years of age or older, but younger than 75 years. * patients should have estimated life expectancy of more than 3 months. * patients must have adequate hepatic function (bilirubin less than 3.0 ㎎/㎗, ast and alt less than three times the upper normal limit). * patients must have adequate renal function (creatinine less than 2.0 ㎎/㎗). exclusion criteria: * presence of significant active infection * presence of uncontrolled bleeding * any coexisting major illness or organ failure * patients with a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible. * nursing women, pregnant women, women of childbearing potential who do not want adequate contraception * patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)

Keywords: allogeneic hematopoietic cell transplantation graft versus host disease bronchiolitis obliterans azithromycin n-acetylcystein fluticasone inhaled steroid
intravitreal ranibizumab for persistent new vessels in diabetic retinopathy(inipe study)

Conditions: Proliferative Diabetic Retinopathy

Summary: to evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy.


Eligibility criteria:
inclusion criteria: * persistent new vessels,defined as fine retinal vessels with dilated buds or tips covered with hemorrhage or associated with recurrent vitreous hemorrhage or paucity of accompanying fibrous tissue and/or increased in extent compared to previous visit,unresponsive to complete panretinal laser photocoagulation performed at least 4 months prior; * logarithm of minimum angle of resolution (logmar) best-corrected visual acuity of 0.17 (snellen equivalent, 20/30) or worse. exclusion criteria: * history of vitrectomy in the study eye; * history of thromboembolic event (including myocardial infarction or cerebral vascular accident); * major surgery within the prior 6 months or planned within the next 28 days; * uncontrolled hypertension; * known coagulation abnormalities or current use of anticoagulative medication other than aspirin.

Keywords: diabetic retinopathy ranibizumab new vessels intravitreal injection persistent retina new vessels
enhancing prep in community settings (epic)

Conditions: HIV

Summary: to test the effectiveness of prepmate, a novel multi-modal, technology-based intervention for pre-exposure prophylaxis (prep) adherence support among young men who have sex with men (msm).


Eligibility criteria:
inclusion criteria: * hiv-uninfected as determined by a negative/non-reactive laboratory test within 7 days of enrollment (as defined in the study-specific procedures (ssp) manual). * interested in initiating prep * eligible to initiate prep * creatinine clearance \> 60 ml/min as estimated by the cockcroft-gault equation within 6 weeks of enrollment * hepatitis b surface antigen (hbsag) negative within 6 weeks enrollment * no other medical contraindications to prep * age 18 years - 29 years * willing and able to provide written informed consent * report having had anal sex with a man in the previous 6 months * meet any of the following risk criteria for the prior 6 months: * any condomless anal sex * three or more anal sex partners * self-reported new sti * known hiv-infected sex partner * have regular access to a computer and/or a smart phone to access the internet and/or apps * have the ability to send and receive text messages * able to read and speak in english exclusion criteria: * prep use within the past year (prep naïve participants will be prioritized). * any reactive or positive hiv test at screening, even if subsequent testing indicates that the person is hiv-uninfected * prior or current participation in the active arm of an hiv vaccine trial * at enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent, make participation in the project unsafe, complicate interpretation of outcome data, or otherwise interfere with achieving the project objectives. * signs or symptoms of acute hiv infection (as described in the ssp manual) * history of pathological bone fracture not related to trauma.

Keywords: adherence prevention
fragility re-fractures prediction score

Conditions: Osteoporosis Risk

Summary: fragility fractures increase among elderly patients worldwide, representing a global burden in terms of disability and care expenditure. osteoporosis is asymptomatic up to the moment in which a first fracture occurs, reason why it is often underdiagnosed. even after that, further fractures do occurr, as osteoporosis is often untreated. several programs have been introduced worldwide to prevent secondary fractures among the population at risk (e.g., international osteoporosis foundation's capture the fracture), and several risk factors are being investigated to generate a predictive score. however, accurate validation is needed to make these scores reliable. in this retrospective observational study, we aim to validate a predictive score trained on a population of elderly patients with a cohort of patients who underwent hip fracture surgery in a high-volume orthopedic center in the region of lombardy.


Eligibility criteria:
inclusion criteria: * people who underwent total or partial hip replacement (icd 9 cm 81.51, 81.52) in five years (2013-2017) at the hospital for a compound fracture of the hip (icd 9 cm 820, 820.01-820.09). exclusion criteria: * people undergoing the same intervention for other reasons (e.g. pathological fracture, icd 9 cm 733.14). icd 9 cm stands for international classification of disease, 9th revision, clinical modification.
effect of fimasartan on extended ras and vascular functions in patients with type 2 diabetes and hypertension

Conditions: Hypertension; Atherosclerosis; Diabetes Mellitus, Type 2; Renin Hypertension

Summary: in this study, we will assess the change of extended renin-angiotensin system including serum ace-2 and angiotensin(1-7) levels and subclinical atherosclerosis after using fimasartan (an arb), compared to amlodipine in hypertensive patients with t2dm.

several clinical trials aimed at studying the benefits of ras blockade in the diabetic complications. hope, renaal, irma2, idnt, ontarget studies proved that ace inhibitors or arbs reduced the risk of diabetic complications. recent studies proved that fimasartan, one of the arbs, stabilizes the activity of renin-angiotensin system. however, understanding the change in concentration of serum ace, ace-2, angiotensin(1-7), and angiotensin-ii should help clinicians select more appropriate drug between ace inhibitors and arbs with clear evidence. moreover, since ras antagonists are the first-line drugs for antihypertensive therapy in patients with t2dm, it is meaningful to understand the change of ras-related factors in serum after using the drugs.

Eligibility criteria:
inclusion criteria: * ≥ 30 years old * type 2 diabetes by american diabetes association criteria * hba1c: 6.5% ≤ - \< 10.0% * systolic blood pressure: 140 ≤ - \< 180 mmhg or diastolic blood pressure: 85 ≤ - \< 110 mmhg * statin (-) or no change in low to moderate intensity statin \[14\] dose in recent 3 months exclusion criteria: * contraindication of fimasartan or amlodipine * history of ras inhibitors (ace inhibitors or arbs) or calcium channel blockers in the previous 3 months * pregnant women, women with potential of pregnancy not using adequate contraception method as evaluated by the investigator, lactating women * type 1 diabetes or diabetes secondary to chronic pancreatitis or to pancreatectomy * confirmed cardiovascular disease (acute coronary syndrome, stroke, or transient ischemic attack) within 3 months of screening * chronic hepatitis b or c (except healthy carrier of hbv), liver disease (ast/alt \> 3-fold the upper limit of normal) * chronic kidney disease (serum creatinine \> 2.0 mg/dl) * hyperkalemia serum potassium \>5.0 meq/l * any previous cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
clinical trial to evaluate the efficacy and safety of fesoterodine in comparison to tolterodine for overactive bladder (oab)

Conditions: Overactive Bladder

Summary: to evaluate the efficacy and safety of fesoterodine in comparison to tolterodine and placebo for overactive bladder


Eligibility criteria:
inclusion criteria: * adult overactive bladder (oab) patients who present with oab symptoms, including urinary frequency \>= 8 per day and urgency urinary incontinence \>=1 per day exclusion criteria: * patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention. * patients with significant hepatic and renal disease or other significant unstable diseases. * oab symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
endoscopic injection sclerotherapy versus n-butyl-2-cyanoacrylate injection

Conditions: Bleeding Esophageal Varices

Summary: endoscopic injection sclerotherapy vs n-butyl-2-cyanoacrylate injection

endoscopic injection sclerotherapy versus n-butyl-2-cyanoacrylate injection in the management of actively bleeding esophageal varices

Eligibility criteria:
inclusion criteria: * cirrhotic patients presented with actively bleeding exclusion criteria: * other sources of ugib than esophageal varices, hepatic encephalopathy or hepatocellular carcinoma (hcc)