Results of endoscopic endonasal dacryocystorhinostomy: a prospective cohort study

Abstract Objective: To evaluate the success rate of endoscopic endonasal Dacryocystorhinostomy Methods: This prospective cohort study was conducted at Ophthalmology and Otorhinolaryngology Department of Shifa Foundation Community Health Centre, Islamabad, Pakistan, from Oct 2017 to Sep 2019. The patients with chronic dacryocystitis who underwent endoscopic endonasal Dacryocystorhinostomy (DCR) were enrolled. Data for demographic information and clinical features (mucocele, deviated nasal septum, epiphora, purulent discharge and regurgitation test, history of acute dacryocystitis and probing and syringing etc.) was noted. Endoscopic DCR with or without lacrimal intubation was performed under general anesthesia. Patients were reviewed at post-operative week1, 1 month, 6 months and 12 months with documentation of epiphora, purulent discharge, need for syringing, nasal adhesions etc. Telephonic interviews were done in cases of missing data. Statistical analysis was done with SPSS 20.0. Results: The study enrolled 47 patients, majority of them were females (87.2%). The mean age of patients was 40.70 ± SD 10.84 yrs, Range 25-66 yrs.. Minimum postoperative follow up period was 12 months; mean duration (14.53 ± 3.0 months). Lacrimal intubation was performed in 31 (66%) patients. Nasal endoscopy was performed and lacrimal tubes were removed after 6 months post operatively. Surgical success was achieved in 46 (97.9%) patients: 37 (78.7 %) patients were completely symptom free, 9 (19.1%) were partially symptomatic and were managed conservatively. Treatment failure requiring repeat surgical procedure was observed in only one patient (2.1%). Continuous...

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The SPARKLE registry: protocol for an international prospective cohort study in patients with alpha-mannosidosis

10.21203/rs.2.19376/v2 ◽

2020 ◽

Author(s):

Julia Hennermann ◽

Nathalie Guffon ◽

Federica Cattaneo ◽

Ferdinando Ceravolo ◽

Line Borgwardt ◽

...

Keyword(s):

Cohort Study ◽

Natural History ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Clinical Care ◽

Clinical Manifestations ◽

Routine Clinical Care ◽

Safety Outcomes ◽

History Of

Abstract Background: Alpha-mannosidosis is a lysosomal storage disorder caused by reduced enzymatic activity of alpha-mannosidase. SPARKLE is an alpha-mannosidosis registry intended to obtain long-term safety and effectiveness data on the use of velmanase alfa during routine clinical care in patients with alpha-mannosidosis. It is a post-approval commitment to European marketing authorization for Velmanase alfa (Lamzede®), the first enzyme replacement therapy for the treatment of non-neurologic manifestations in patients with mild to moderate alpha-mannosidosis. In addition, SPARKLE will expand the current understanding of alpha-mannosidosis by collecting data on the clinical manifestations, progression, and natural history of the disease in treated and untreated patients, respectively.Results: The SPARKLE registry is designed as a multicenter, multinational, noninterventional, prospective cohort study of patients with alpha-mannosidosis, starting patient enrollment in 2020. Patients will be followed for up to 15 years. Safety and effectiveness as post-authorization outcomes under routine clinical care in patients with treatment will be evaluated. The primary safety outcomes are the rate of adverse events (anti-velmanase alfa-immunoglobulin G antibody development, infusion-related reactions, and hypersensitivity). Secondary safety outcomes include the evaluation of medical events, change in vital signs, laboratory tests, physical examination, and electrocardiogram results. The primary effectiveness outcome is a global treatment response rate, evaluated as the individual aggregate of single endpoints from pharmacodynamic, functional, and quality of life effectiveness outcomes; secondary effectiveness outcomes are to characterize the population of patients with alpha-mannosidosis with regard to clinical manifestation, progression, and natural history of the disease. Any patient in the European Union with a diagnosis of alpha-mannosidosis who is willing to participate will likely be eligible for inclusion in the registry. Publications to disseminate scientific insights from the registry are planned. Conclusion: This study will provide real-world data on the long-term safety and effectiveness of velmanase alfa in patients with alpha-mannosidosis during routine clinical care and increase the understanding of the natural course, clinical manifestations, and progression of this ultra-rare disease.

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Electrocardiographic Findings of COVID-19 Patients and Their Correlation with Outcome; a Prospective Cohort Study

Frontiers in Emergency Medicine ◽

10.18502/fem.v5i2.5608 ◽

2021 ◽

Author(s):

Mehdi Pishgahi ◽

Mahmoud Yousefifard ◽

Saeed Safari ◽

Fatemeh Ghorbanpouryami

Keyword(s):

Diabetes Mellitus ◽

Cohort Study ◽

Prognostic Factors ◽

Hospital Mortality ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

P Wave ◽

Axis Deviation ◽

T Wave ◽

History Of

Introduction: Being infected with COVID-19 is associated with direct and indirect effects on the cardiopulmonary system and electrocardiography can aid in management of patients through rapid and early identification of these adversities. Objective: The present study was designed aiming to evaluate electrocardiographic changes and their correlation with the outcome of COVID-19 patients. Methods: This Prospective cohort study was carried out on COVID-19 cases admitted to the emergency department of an educational hospital, during late February and March 2020. Electrocardiographic characteristics of patients and their association with in-hospital mortality were investigated. Results: One hundred and nineteen cases with the mean age of 60.52±13.45 (range: 29-89) years were studied (65.5% male). Dysrhythmia was detected in 22 (18.4%) cases. T-wave inversion (28.6%), pulmonale P-wave (19.3%), left axis deviation (19.3%), and ST-segment depression (16.8%) were among the most frequently detected electrocardiographic abnormalities, respectively. Twelve (10.1%) cases died. There was a significant correlation between in-hospital mortality and history of diabetes mellitus (p=0.007), quick SOFA score > 2 (p<0.0001), premature ventricular contraction (PVC) (p=0.003), left axis deviation (LAD) (p=0.039), pulmonale P-wave (p<0.001), biphasic P-wave (p<0.001), inverted T-wave (p=0.002), ST-depression (p=0.027), and atrioventricular (AV) node block (p=0.002). Multivariate cox regression showed that history of diabetes mellitus, and presence of PVC and pulmonale P-wave were independent prognostic factors of mortality. Conclusions: Based on the findings of the present study, 18.4% of COVID-19 patients had presented with some kind of dysrhythmia and in addition to history of diabetes, presence of PVC and pulmonale P-wave were among the independent prognostic factors of mortality in COVID-19 patients.

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The SPARKLE registry: protocol for an international prospective cohort study in patients with alpha-mannosidosis

Orphanet Journal of Rare Diseases ◽

10.1186/s13023-020-01549-8 ◽

2020 ◽

Vol 15 (1) ◽

Author(s):

Julia B. Hennermann ◽

Nathalie Guffon ◽

Federica Cattaneo ◽

Ferdinando Ceravolo ◽

Line Borgwardt ◽

...

Keyword(s):

Cohort Study ◽

Natural History ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Clinical Care ◽

Clinical Manifestations ◽

Routine Clinical Care ◽

Safety Outcomes ◽

History Of

Abstract Background Alpha-mannosidosis is a lysosomal storage disorder caused by reduced enzymatic activity of alpha-mannosidase. SPARKLE is an alpha-mannosidosis registry intended to obtain long-term safety and effectiveness data on the use of velmanase alfa during routine clinical care in patients with alpha-mannosidosis. It is a post-approval commitment to European marketing authorization for Velmanase alfa (Lamzede®), the first enzyme replacement therapy for the treatment of non-neurologic manifestations in patients with mild to moderate alpha-mannosidosis. In addition, SPARKLE will expand the current understanding of alpha-mannosidosis by collecting data on the clinical manifestations, progression, and natural history of the disease in treated and untreated patients, respectively. Results The SPARKLE registry is designed as a multicenter, multinational, noninterventional, prospective cohort study of patients with alpha-mannosidosis, starting patient enrollment in 2020. Patients will be followed for up to 15 years. Safety and effectiveness as post-authorization outcomes under routine clinical care in patients with treatment will be evaluated. The primary safety outcomes are the rate of adverse events (anti-velmanase alfa-immunoglobulin G antibody development, infusion-related reactions, and hypersensitivity). Secondary safety outcomes include the evaluation of medical events, change in vital signs, laboratory tests, physical examination, and electrocardiogram results. The primary effectiveness outcome is a global treatment response rate, evaluated as the individual aggregate of single endpoints from pharmacodynamic, functional, and quality-of-life effectiveness outcomes; secondary effectiveness outcomes are to characterize the population of patients with alpha-mannosidosis with regard to clinical manifestation, progression, and natural history of the disease. Any patient in the European Union with a diagnosis of alpha-mannosidosis who is willing to participate will likely be eligible for inclusion in the registry. Publications to disseminate scientific insights from the registry are planned. Conclusion This study will provide real-world data on the long-term safety and effectiveness of velmanase alfa in patients with alpha-mannosidosis during routine clinical care and increase the understanding of the natural course, clinical manifestations, and progression of this ultra-rare disease.

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Single-center prospective, cohort study of the natural history of acute pancreatitis

Pancreatology ◽

10.1016/j.pan.2014.05.712 ◽

2014 ◽

Vol 14 (3) ◽

pp. S98-S99

Author(s):

Giulia Martina Cavestro ◽

Leandro Gioacchino ◽

Milena Di Leo ◽

Raffaella Alessia Zuppardo ◽

Olivia B. Morrow ◽

...

Keyword(s):

Acute Pancreatitis ◽

Cohort Study ◽

Natural History ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Single Center ◽

History Of

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Uterocervical angle measurement for preterm birth prediction in singleton pregnant women with no history of preterm birth and normal cervical length: A prospective cohort study

European Journal of Obstetrics & Gynecology and Reproductive Biology ◽

10.1016/j.ejogrb.2020.06.020 ◽

2020 ◽

Vol 252 ◽

pp. 30-35

Author(s):

Rapphon Sawaddisan ◽

Ounjai Kor-anantakul ◽

Ninlapa Pruksanusak ◽

Alan Geater

Keyword(s):

Cohort Study ◽

Preterm Birth ◽

Pregnant Women ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Cervical Length ◽

Angle Measurement ◽

History Of

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Natural History of HumanCalicivirusInfection: A Prospective Cohort Study

Clinical Infectious Diseases ◽

10.1086/341408 ◽

2002 ◽

Vol 35 (3) ◽

pp. 246-253 ◽

Cited By ~ 347

Author(s):

Barry Rockx ◽

Matty de Wit ◽

Harry Vennema ◽

Jan Vinjé ◽

Erwin de Bruin ◽

...

Keyword(s):

Cohort Study ◽

Natural History ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

History Of

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Socio-economic, clinical and biological risk factors for mother - to – child transmission of HIV-1 in Muhima health centre (Rwanda): a prospective cohort study

Archives of Public Health ◽

10.1186/0778-7367-71-4 ◽

2013 ◽

Vol 71 (1) ◽

Cited By ~ 8

Author(s):

Maurice Bucagu ◽

Jean de Dieu Bizimana ◽

John Muganda ◽

Claire Perrine Humblet

Keyword(s):

Risk Factors ◽

Cohort Study ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Health Centre ◽

Mother To Child Transmission ◽

Child Transmission ◽

Biological Risk ◽

Mother To Child ◽

Hiv 1

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Migraine is a Risk Factor for Hypertensive Disorders in Pregnancy: A Prospective Cohort Study

Cephalalgia ◽

10.1111/j.1468-2982.2008.01704.x ◽

2009 ◽

Vol 29 (3) ◽

pp. 286-292 ◽

Cited By ~ 68

Author(s):

F Facchinetti ◽

G Allais ◽

RE Nappi ◽

R D'Amico ◽

L Marozio ◽

...

Keyword(s):

Cohort Study ◽

Prospective Cohort Study ◽

Prospective Cohort ◽

Primary Headaches ◽

Chronic Hypertension ◽

Hypertensive Disorders ◽

Increased Risk ◽

Hypertensive Disorders In Pregnancy ◽

History Of ◽

In Pregnancy

The aim was to assess whether women suffering from migraine are at higher risk of developing hypertensive disorders in pregnancy. In a prospective cohort study, performed at antenatal clinics in three maternity units in Northern Italy, 702 normotensive women with singleton pregnancy at 11–16 weeks' gestation were enrolled. Women with a history of hypertensive disorders in pregnancy or presenting chronic hypertension were excluded. The presence of migraine was investigated according to International Headache Society criteria. The main outcome measure was the onset of hypertension in pregnancy, defined as the occurrence of either gestational hypertension or preeclampsia. Two hundred and seventy women (38.5%) were diagnosed with migraine. The majority (68.1%) suffered from migraine without aura. The risk of developing hypertensive disorders in pregnancy was higher in migraineurs (9.1%) compared with non-migraineurs (3.1%) [odds ratio (OR) adjusted for age, family history of hypertension and smoking 2.85, 95% confidence interval (CI) 1.40, 5.81]. Women with migraine also showed a trend to increased risk for low birth weight infants with respect to women without migraine (OR 1.97, 95% CI 0.98, 3.98). Women with migraine are to be considered at increased risk of developing hypertensive disorders in pregnancy. The diagnosis of primary headaches should be taken into account at antenatal examination.

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