Kornimate/medical-research-clean huggingface dataset:
follow up of diabetic macular edema treated by aflibercept (eylea®) with oct-angiography

Conditions: Diabetic Macular Edema

Summary: this is a non-interventional, longitudinal, retrospective and prospective, non-controlled, single arm study in naive or non-naive patients with diabetic macular edema for which aflibercept (eylea®) therapy is indicated.


Eligibility criteria:
inclusion criteria: * man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potential (hormonal or any intrauterine devices). * patients with type i or ii diabetes (as defined by criteria of american diabetes association ada or world health organization who) with an glycosylated hemoglobin rate (hba1c) \< 10.0%, at initial visit (first eylea® injection). * patients with diabetes treatment unchanged within the last 3 months prior to initial visit (first eylea® injection). * patients showing a visual lost due to a diabetic macular edema (dme) in the central region and not for another reason, assessed by the investigateur. the visual acuity of the fellow eye is not an exclusion criteria. * patient to whom a treatment by aflibercept is indicated and oct-angiography is performed at each injection visit. * patients affiliated to social security system. * patient who has been given appropriate information about the study objectives and instructions who has given his/her non-opposition prior to conduct any study-related procedures and examination. non iclusion criteria: * treatment with an anti vegf (eylea®, lucentis® or avastin®) administrated by intravitreal injection within 3 months prior to initial visit in the study eye * treatment with ozurdex® administrated by intravitreal injection within 6 months prior to initial visit (first eylea® injection) in the study eye * history of or active ocular /intraocular inflammation (uveitis) at initial visit (first eylea® injection), in either eye * intra-ocular pressure ≥ 25 mmhg * patient with neocascular glaucoma history * patient with foveolar exsudat that interfere with images analysis. * history or current evidence of hypersentivity to mydriatic eye drops * vitreomacular traction in the study eye * panretinal coagulation within 3 months prior to initial visit (first eylea® injection), in the study eye. * cataract surgery in the study eye within the 6 months prior to initial visit (first eylea® injection) * history of vitretectomy in the study eye * treatment with systemic anti vegf medications for cancer * history of cerebrovascular accident within 3 months prior to initial visit (first eylea® injection), renal failure, uncontrolled arterial hypertension (pas\>160 mm hg and/ or pad\>100 mm hg) * patient who does not meet the local indication criteria for eylea® treatment. contraindications listed in the smpcs must be taken into account * participation in any investigational study with exclusion period in progress at the initial visit (first eylea® injection) * patients under guardianship * pregnant or breastfeeding woman.
a study to evaluate disease control and treatment pattern in participants with moderate to severe inflammatory bowel disease (ibd) in real life practice

Conditions: Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Summary: the purpose of this study is to characterize the treatment patterns associated with biologics agents use or non-biological therapy in participants with moderate to severe ulcerative colitis (uc) and crohn's disease (cd).

this is a non-interventional, retrospective and prospective study of participants with ibd. this study will collect data to provide accurate and comprehensive information related to treatment patterns associated with biologics use or non-biological therapy in participants with moderate to severe uc and cd in routine clinical practice. the study will have retrospective data collection from past records of participants within the last 2 years before participant's enrollment. the prospective part of the study will include one year of observation and data collection after the participant's enrollment in the study. the study will enroll approximately 2000 participants. participants will be enrolled in one of the two groups: * uc participants * cd participants this multi-center trial will be conducted in russia, belarus and kazakhstan. the overall period of observation in this study will be approximately 12 months. participants will make 2 visits within their routine practice to the clinic after the enrollment into the study including a final visit at month 12.

Eligibility criteria:
inclusion criteria: 1. has confirmed diagnosis of cd or uc for at least 2 years prior to enrollment in the study. 2. has a moderate to severe ibd flare at the time of enrollment or in participant anamnesis within 2 years before enrollment treated with steroids or/ and immunosuppressive agents or/ and biologic therapy. ibd flare(s) must be confirmed in the source documentation. 3. current treatment with steroids or/ and immunosuppressive agents or/ and 5-aminosalicylate (asa) or/ and biologic therapy. exclusion criteria: 1. current or previous (within the last two years) indeterminate or not classified colitis. 2. changing of ibd type in anamnesis (that is, from uc to cd, etc) within the last two years. 3. current, previous (within the last two years) or planned (for the next one year) participation in interventional clinical trial. 4. presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 5. has received previous treatment with biologic therapy/immunosuppressive agents for conditions other than ibd ever in their lifetime.

Keywords: drug therapy
cross sectional survey on the burden and impacts of chronic hepatitis b in the rural area of niakhar, senegal

Conditions: Chronic Hepatitis b

Summary: this study aims at estimating the prevalence of chronic hepatitis b virus (hbv) infection in rural senegal (area of niakhar) and at evaluating the associated burden in terms of both health-related and socio-economic consequences.

the prevalence of chronic hbv infection in senegal is among the highest worldwide (10% to 17%) but available prevalence estimates relie on studies conducted in specific subgroups (such as military, pregnant women or blood donors). the prevalence of hbv chronic infection remains undocumented in the general population of senegal, and its health-related and socio-economic consequences need to be estimated. this research is based on a cross-sectional survey conducted in the general population with collection of biological, socio-behavioral and economic data at two levels (at the participants' home and in healthcare centers) in the area of niakhar (located at 135 kms at the east of dakar). the research includes three phases as follows: (i) preliminary phase: information and communication about the research within the community, training of stakeholders and pilot survey (ii) collection of data in the general population (iii) communication of results on hbv status to participants and collection of additional data among hbv chronic individuals

Eligibility criteria:
inclusion criteria: (i) living in a household of the research zone (individuals living within participating households for at least 6 months, even non permanently: seasonal workers or individuals studying outside the niakhar zone) (ii) being aged of at least 6 months (iii) giving informed consent to participate in the research exclusion criteria: (i) being an adult unable to sign informed consent (ii) being a child whose parents or legal guardian is not present in the household at the time of the survey

Keywords: prevalence vaccine coverage risk factors morbidity mortality quality of life economic vulnerability food security treatment needs decentralized care health costs caregivers training
vehicle controlled efficacy and safety study of two dose regimens of cd07223 1.5% topical gel in impetigo

Conditions: Impetigo

Summary: this study will be a multicenter, randomized, vehicle controlled, parallel, group, double blind study. eligible subjects with a clinical diagnosis of impetigo will be randomized to one of four treatment groups: 1.5% cd07223 topical gel applied bid; 1.5% cd07223 topical gel applied tid; vehicle topical gel applied bid;vehicle topical gel applied tid. all treatments will be administered for 7 days. disease activity for the target lesion will be evaluated using the skin infection rating scale (sirs) score.


Eligibility criteria:
inclusion criteria: * male or female 2 years of age or older * clinical diagnosis of primary impetigo (bullous or non bullous) * minimum diameter of target lesion to be one centimeter measured either as length or width. * presence of at least one and no more than ten lesions per subject at the time of screening * the infected lesions' total area (as determined by the investigator) must be less than 100 cm2 in total area for subjects 18 years of age or older, or up to a maximum of 2% total body surface area for subjects younger than 18 years of age. * skin infection rating scale (sirs) total score of the target lesion of at least 4 exclusion criteria: * presence of other active skin diseases at or near the target lesion area to be treated * a subject whose disease is so widespread or severe that, in the opinion of the investigator, oral antibiotic treatment is needed * signs and symptoms of another current infection requiring antibiotic treatment * tympanic temperature at screening/baseline exceeding 38 degrees celsius (100.4 degrees fahrenheit) in a pediatric subject or 37.8 degrees celsius (100 degrees fahrenheit) in an adult subject * history of hepatitis b or c, hiv/ aids, or other immunodeficiency disease * concurrent or recent scabies infection or lice infestation (pediculosis) of the scalp * use of systemic antibiotics or systemic steroids within 14 days prior to study entry. a history of three or more courses of systemic antibiotics within the 3 month period immediately prior to screening will also be considered exclusionary * use of topical antibiotics, topical antibacterials, topical antifungals or topical steroids within 14 days prior to study entry on any skin lesion (as deemed significant by the investigator by virtue of the lesion's nature and/or position to impact on the effectiveness of the study drug) * participation in any other clinical study or use of any investigational drugs or investigational device within 30 days prior to enrollment * presence of secondarily infected traumatic lesions (e.g. surgical wounds, animal/insect bites, burns, lacerations and abrasions). * another family member in same household currently enrolled in this study or another family member in the same household with active impetigo
clinical trial on the effect of autologous oral mucosal epithelial sheet transplantation

Conditions: Limbal Stem Cell Deficiency; Stevens-johnson Syndrome; Ocular Cicatricial Pemphigoid; Chemical Burn

Summary: to investigate the effect of ocular surface reconstruction and assess the safety in cultivated oral mucosal epithelial cell sheet transplantation (comet) regarding patients with cicatricial change of ocular surface.

interventional study for treatment of patients with cicatricial change of ocular surface. single group: (limbal stem cell deficiency group) treatment: after cultivating autologous oral mucosal epithelial cell sheet, the sheet will be transplanted to the ocular surface of the patients inclusion criteria 1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea 2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment 3. patient who agree this clinical trial 4. patient with the eyes in which best corrected visual acuity is less than counting finger 5. patient who is older than sixteen year old exclusion criteria 1. patient who has relevant corneal transparency 2. patient who is on the pregnancy or has a plan of pregnancy within 1 year 3. patient who has corneal infection 4. patient who has diagnosis of hbv, hcv, hiv, syphilis 5. patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease 6. patient who has malignancy 7. patient who shows hypersensitivity to bovine protein. primary outcome epithelization of corneal surface (6 months after cell sheet transplantation) secondary outcome visual acuity (6 months after cell sheet transplantation)

Eligibility criteria:
inclusion criteria: 1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea 2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment 3. patient who agree this clinical trial 4. patient with the eyes in which best corrected visual acuity is less than counting finger 5. patient who is older than sixteen year old exclusion criteria: 1. patient who has relevant corneal transparency 2. patient who is on the pregnancy or has a plan of pregnancy within 1 year 3. patient who has corneal infection 4. patient who has diagnosis of hbv, hcv, hiv, syphilis 5. patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease 6. patient who has malignancy 7. patient who shows hypersensitivity to bovine protein.

Keywords: limbal stem cell deficiency cultivated oral mucosal cell sheet transplantation ocular surface reconstruction
latarjet procedure: comparative outcomes study of arthroscopic versus mini-open approach with minimum 2-year follow-up

Conditions: Joint Instability

Summary: to date, use of arthroscopic procedure to perform latarjet procedure is still technically demanding. the benefits of arthroscopic procedure need to be evaluated compared to the mini-invasive approach. the aim of this study was to assess postoperative pain during the first week, and the positioning of coracoid bone block at the anterior aspect of the glenoid. at minimum 2 years follow-up, the recurrence of shoulder instability and functional evaluation of patients according to the western ontario score index (wosi) were assessed.

this prospective comparative study was performed at two centers in 2012. each center performed one procedure so this study was observational. all patients with a chronic anterior instability requiring bone grafting (instability severity index score\>3) were included. the latarjet procedure was performed by mini-open approach (set arthrex, naples, fl) in the first group, and by arthroscopic approach (set depuy-mitek, raynham, ma) in the second group. the analgesic postoperative protocol was standardized (paracetamol, non-steroidal anti-inflammatory, tramadol).

Eligibility criteria:
inclusion criteria: * chronic anterior instability requiring bone grafting (instability severity index score\>3) exclusion criteria: * patient refusal

Keywords: shoulder instability
trans-pulmonary biomarkers in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: the investigators are testing whether the addition of pulmonary hypertension-related biomarkers, measured across the pulmonary circulation, to the standard hemodynamic evaluation for pulmonary hypertension will lead to more informed choices of pulmonary hypertension therapy and improved patient outcomes.

eligible participants with known or suspected pulmonary hypertension undergoing a clinically indicated right heart catheterization may be enrolled. clinical data and blood samples will be analyzed.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * undergoing rhc for ph evaluation exclusion criteria: * anemia defined as hgb \< 10 g/dl and hct \< 30 * pregnancy at the time of rhc (as assessed by urine or serum pregnancy test on the day of the procedure) * left ventricular ejection fraction ≤ 40% * atrial fibrillation at the time of rhc (as defined by telemetry monitoring or ekg on the day of the procedure) * ipf, cteph, copd/osa as the dominant etiology of ph * patient is currently taking ph medication or long-acting nitrates at the time of their rhc.

Keywords: pulmonary hypertension biomarker cardiac circulation heart disease lung disease
reliability of sensor spacing for nirs in traumatic tibia fractures

Conditions: Orthopedic Disorders; Tibial Fractures

Summary: this is a study intended to evaluate a non-invasive device that uses light to measure the amount of oxygen in the muscles of injured and non-injured legs in specific situations. the name of this technology is nirs (near-infrared spectroscopy). the goal of this study is to collect the information necessary to understand the use of the nirs monitoring system to diagnose and direct treatment decisions in case of complications sometimes experienced in traumatic tibia fracture, such as excessive swelling called acute compartment syndrome (acs).

this study seeks to further develop the use of nirs technology in the diagnosis of acute compartment syndrome. nirs values normally increase in traumatized legs compared to the contralateral uninjured leg or forearm, indicative of a hyperemic response. the investigators hopes to build upon the current knowledge and verify the ability to accurately detect acs using two easily identified and accessible leg compartments, the anterior and superficial posterior utilizing the nonin 7600 oximeter with the sensor model 8004cv. additionally, since this device was originally designed with brain tissue in mind, the nirs device will collect vital engineering data that will be used to validate the algorithm used to produce the oxygenation values in injured muscle tissue.

Eligibility criteria:
inclusion criteria: * unilateral leg injury * enrolled within 48 hours of injury * subjects with 'severe' leg injuries presenting at trauma center that meet at least one of the following from each group below: anatomic location: * tibia/fibula shaft fracture * tibial plateau fracture (schatzker iii-vi) high energy mechanism of injury: * fall from \>8 foot height * motor vehicle collision (\> 15 mph) * motor vehicle versus pedestrian accident * high velocity gunshot wound * crush injury * sport/recreation exclusion criteria: * application of nirs monitoring would be an impediment to care * known prior leg fractures, patient has already undergone fasciotomy of the injured leg prior to enrollment * history of peripheral vascular disease or concurrent lower extremity vascular injury/surgery * admission for atraumatic medical reasons * subject is unable to provide informed consent, or consent cannot be obtained from a legally authorized representative * complete spinal cord injuries, bilateral upper extremity injuries, or amputation/mangled lower extremity * patients who are in police custody at presentation to the hospital or who are pregnant * patient has an open injury on the injured leg that is large enough that at least one nirs sensor cannot be safely placed over the compartment * bilateral leg injuries * not able to be enrolled within 48 hours after injury

Keywords: acute compartment swelling (acs) near-infrared spectroscopy (nirs)
chronic obstructive pulmonary disease and weaning from mechanical ventilation in difficult to wean patients

Conditions: Respiratory Failure

Summary: to evaluate and compare two methods of weaning from mechanical ventilation in patients with chronic obstructive pulmonary disease (copd) where the extubation failed.

a prospective, randomized trial was performed in a multidisciplinary intensive care unit (icu) for the duration of 2 years. a total of 136 copd patients who required mechanical ventilation longer than 24 h fulfilled the inclusion criteria and they present the research sample. after fulfilling the criteria for weaning, patients were randomized to a 2-h spontaneous breathing trial with either t-tube or pressure support ventilation (psv). the patients with successful 2-h trial were extubated and were excluded from further research. patients with 2-h trial failure were defined as difficult to wean, they had mechanical ventilation reinstated and the same weaning procedure was repeated after 24 h, if the patient again fulfilled the weaning criteria. in these patients, two methods of weaning were compared according to the patients clinical characteristics, objective parameters and procedure outcome. 31 (47%) patient with t-tube and 32 (46%) patients with psv had 2-h trial failure. of those patients, successful extubation was in 17 (56%) patients with t-tube and in 23 (72%) with psv (p \<0.001), whereas extubation failure was in 14 (44%) patients with t-tube and in 9 (28%) patients with psv (p \<0.001). mechanical ventilation duration was 186.7 h with t-tube and 163.2 h with psv (p \<0.001), time spent in icu was 240.7 h with t-tube and 210.2 h with psv (p \<0.001). in patients with copd who failed the 2-h spontaneous breathing trial, based on parameters of procedure outcome, high advantage of psv method was confirmed.

Eligibility criteria:
inclusion criteria: * copd * exacerbation of dyspnea \<2 weeks * signs of respiratory muscle dysfunction exclusion criteria: * non copd patients * age \<18 years * tracheotomy * mv duration shorter than 24h * use of mv on admission to the icu or transfer to some other icu for treatment continuation * patients who died or weaning from mv was discontinued because of another associated disorder * central nerve system disorders unrelated to hypercapnic encephalopathy or hypoxemia * cardiac arrest within 5 days * patients scheduled for organ donation

Keywords: respiration copd mechanical ventilation ventilator weaning respiratory failure icu pressure support ventilation
a multicentre, randomized, double-blind, allopurinol controlled study to evaluate the efficacy and safety of shr4640 in subjects with gout

Conditions: Gout

Summary: this study will assess the serum uric acid lowering effects and safety of shr4640 compared to allopurinol in subjects with gout.


Eligibility criteria:
inclusion criteria: 1. subject who met 1977 or 2015 acr (american college of rheumatology) classification of gout and has a serum acid ≥ 480 μmol/l at screening; 2、18 kg/m2 ≤ body mass index (bmi) ≤ 35 kg/m2. exclusion criteria: 1. subject who is pregnant or breastfeeding; 2. alanine aminotransferase or aspartate aminotransferase or total bilirubin\>1.5 upper normal limit; 3. subject with a positive test for hla-b\*5801; 4. estimated glomerular filtration rate (mdrd formula) \<60ml/min; 5. hba1c≥8%; 6. subject with known hypersensitivity or allergy to shr4640 and allopurinol, or any component of shr4640; 7. subject with kidney stones or suspicion of kidney stones; 8. subject who has acute gout flares within 2 weeks before randomization; 9. subject with a history of malignancy within the previous 5 years; 10. subject with a history of active peptic ulcer within a year; 11. subject with a history of xanthine urine.