louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05979662: Endoscopic Frontal Sinus Surgery Draf III in Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps
Official title: Clinical Evaluation of Primary Endoscopic Frontal Sinus Surgery Grade 6 (Draf III) in Patients With Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endoscopic Frontal Sinus Surgery
Chronic Rhinosinusitis With Nasal Polyps
Draf III
Draf I or IIa
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of the primary endoscopic frontal sinus surgery on the clinical outcome in patients having moderate to severe eosinophilic chronic rhinosinusitis with polyps with primary outcome measures in form of recurrence of polyp using endoscopic polyp score and Secondary outcome measures include Lund MacKay score, SNOT-22 and need for corticosteroid to control polyp postoperatively.

Detailed description: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a common inflammatory disorder, affecting about 4% of the population worldwide and strongly impacts the quality of life of affected patient.

Eosinophilic chronic rhinosinusitis (ECRS) is a subtype of recalcitrant Chronic rhinosinusitis . Patients with ECRS and generally having a tissue eosinophil \>10 cells per high power field (HPF), have worse disease severity and poorer treatment outcomes compared to non-Eosinophilic chronic rhinosinusitis.

Eligibility criteria: Inclusion Criteria:

• Patients with moderate or severe eosinophilic chronic rhinosinusitis with polyps who failed appropriate medical treatment in the form of antibiotic, systemic and local corticosteroid for 3 months .

Exclusion Criteria:

* Narrow anteroposterior diameter of frontal sinus ostium(1cm or less)
* Patients showing less or highest degree of radiological complexity of surgery on studying the Computed Tomography.
* Any contraindication for general anesthesia.
* Patients below age of 18 years.
* Incomplete follow up
* previous sinus surgery

Primary outcomes:
measure: Recurrence of polyp using endoscopic polyp score
timeFrame: One year postoperatively
Secondary outcomes:
measure: Lund MacKay score
timeFrame: One year postoperatively
measure: Sinonasal Outcome Test- 22
timeFrame: One year postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: El-Gharbia
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT04670562: Longitudinal Follow up of Patients With Pleural Effusion
Official title: Longitudinal Follow up of Patients With Pleural Effusion in South Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pleural Effusion, Malignant
Prognosis
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who presented with pleural effusion and undergo diagnostic/therapeutic thoracentesis

Brief summary: This study aims to evaluate the clinical course of patients diagnosed with pleural effusion and determine various clinical factors and biomarkers associated that can predict the diagnosis and clinical outcome and prognosis of patients with pleural effusion due to specific causes.

Detailed description: Patients who presented to Seoul National University Bundang Hospital with pleural effusion would be recruited. Pleural fluid and blood samples would be collected. All patients will receive routine diagnostic procedures and medical care and treatments according to the diagnosis; the original cancer if diagnosed with malignant effusion, and managements for pleural effusion control. Patients would be observed for the clinical course and prognosis up to 3 years without any interventions caused by this study.

Eligibility criteria: Inclusion Criteria:

* Patients presented with pleural effusion
* Patients who undergo thoracentesis and fluid analysis for diagnosis and management

Exclusion Criteria:

* Patients who refuse to be enrolled

Primary outcomes:
measure: Mortality
timeFrame: From date of diagnosis of malignant pleural effusion until the date of death, assessed up to 36 months.
Secondary outcomes:
measure: Disease progression
timeFrame: From date of diagnosis of malignant pleural effusion until the date of first documented disease progression, assessed up to 36 months.
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Yeon Wook Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02901262: Continuous Quantified EEG in NeuroIntensive Care
Official title: Utility of Continuous Electroencephalogram and Derived Variables in NeuroIntensive Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coma
Traumatic Brain Injury
Subarachnoid Hemorrhage
Ischemic Stroke
Keywords: continuous EEG
Lead sponsor: Azienda Ospedaliera San Gerardo di Monza
Sponsor class: OTHER
Collaborators: name: Papa Giovanni XXIII Hospital
First posted: 2016-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensivists will evaluate tracing from patients in coma after a traumatic/vascular event admitted to neurointensive care and recorded with continuous EEG for clinical reasons

Brief summary: To evaluate the ability of NICU (NeuroIntensive Care Unit) staff to interpret, before and after a training period, symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG (continuous electroencephalography/quantitative electroencephalography) tracings.

Detailed description: Using a web based tool, the clinicians of the two study centers will review 24 hours of recording (raw EEG data + derived qEEG variables).

The intensivists will evaluate:

* simmetry,
* sedation level,
* seizures activities and
* artefact on continuous cEEG/qEEG tracings. The same tracings will be blindly reviewed by a certified neurophysiologist (using the app). The neurophysiologist evaluation will be considered as "reference".

The results of the evaluation will be compared (intensivists vs. neurophysiologist) in order to understand if the intensivists are able to adequately identify the pathological findings.

The study period will be:

* before a formal training
* after a formal training by neurophysiologist in order to understand if the training is able to improve the intensivists performance.

Eligibility criteria: Inclusion Criteria:

Intensivists wil evaluate daily qEEG recordings of:

* Patients in coma after a traumatic/vascular event
* Admitted to neurointensive care and
* Recorded with continuous EEG for clinical reasons

Exclusion Criteria:

* No EEG recording \> 24 hours

Primary outcomes:
measure: Number of Correct qEEG Evaluations
timeFrame: 2 months
Secondary outcomes:
measure: Kappa Coefficient of Agreement Between Intensivists and Neurophysiologists After Training
timeFrame: 12 months
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni Xxiii
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
Study officials:
affiliation: Università Milano Bicocca
name: Giuseppe Citerio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04699162: Efficacy of Intermediate and High Intensity Regimens in Patients With Relapsed Acute Lymphoblastic Leukemia
Official title: Efficacy of Intermediate and High Intensity Regimens in Patients With Relapsed Acute Lymphoblastic Leukemia. Experience of Two Centers in Mexico City
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Keywords: Survival
Leukemia
Relapse
Retrospective study
Lead sponsor: Hospital General de Mexico
Sponsor class: OTHER_GOV
First posted: 2021-01-07
Enrollment: 56
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with first diagnosis of acute lymphoblastic leukemia

Brief summary: The aim of this study is to describe the survival and relapses of patients with diagnosis of acute lymphoblastic leukemia at two tertiary level hospitals in the metropolitan area of the valley of Mexico

Detailed description: Retrospective, observational study in patients with diagnosis of acute lymphoblastic leukemia, according to the criteria of the World Health Organization, from July, 2016, to October, 2020. The patients were cared for in the hematology department of the Hospital General de Mexico and in the hematology department of the Hospital Regional de Alta Especialidad Ixtapaluca. Relapse was considered in those cases with more than 5% of blasts in bone marrow and as relapse to the central nervous system with the presence of blasts in cerebrospinal fluid.

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of acute lymphoblastic leukemia according to the criteria of the World Health Organization.

Exclusion Criteria:

* Age less than 15 years
* Age over 60 years

Primary outcomes:
measure: Overall survival
timeFrame: 4-years
measure: Progression free survival
timeFrame: 4-years
measure: Number of relapses
timeFrame: 4-years
Secondary outcomes:
Other outcomes:
Locations:
city: Ixtapaluca
country: Mexico
facility: Hospital Regional de Alta Especialidad de Ixtapaluca
state: State Of Mexico
city: Mexico City
country: Mexico
facility: Hospital General de México "Dr. Eduardo Liceaga"
Study officials:
affiliation: Hospital General de México Dr. Eduardo Liceaga
name: Christian O Ramos-Peñafiel, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02818062: Severe Intraocular Infection
Official title: Severe Intraocular Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endophthalmitis
Keywords: Endophthalmitis
Cytokines
Chemokines
Inflammation
Regulation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 263
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from referral centers coming for post-operative endophthalmitis. Multicenter studies (in France: Strasbourg, Dijon, Grenoble, Nancy).

Brief summary: The host-immune reaction to infection is essential for the comprehension of the disease and the development of new therapies.

The aim of the study is to describe intraocular cytokines network in aqueous humor using multiplex immunoassay, during severe intraocular infection.


Eligibility criteria: Inclusion Criteria:

* Post-operative endophthalmitis
* Cataract

Exclusion Criteria:

* None

Primary outcomes:
measure: Intraocular cytokine network. Intraocular levels of 27 cytokines
timeFrame: Once in the 24 hours following the admission
Secondary outcomes:
measure: Visual acuity
timeFrame: Once in the 24 hours following the admission, then 3 months, 6 months and 1 year
Other outcomes:
Locations:
city: Colmar
country: France
facility: Service d'Ophtalmologie, Hôpital Pasteur
city: Dijon
country: France
facility: Service d'Ophtalmologie, Hôpital Général de Dijon
city: Grenoble
country: France
facility: Service d'Ophtalmologie, Hôpital Michallon
city: Mulhouse
country: France
facility: Service d'Ophtalmologie, Centre Hospitalier de Mulhouse
city: Nancy
country: France
facility: Service d'Ophtalmologie, CHU de Nancy
city: Strasbourg
country: France
facility: Service d'Ophtalmologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
city: Vandoeuvre Les Nancy
country: France
facility: Service d'Ophtalmologie, Hôpital de Brabois
Study officials:
References:
Clinical trial NCT00551291: A Study of NeoRecormon (Epoetin Beta), CellCept (Mycophenolate Mofetil) and Prednisone in Patients With Low or Intermediate Myelodysplastic Syndromes.
Official title: An Open Label Study of the Effects of a Combination of NeoRecormon, CellCept and Prednisone on Hematological Parameters and Cytogenesis in Patients With Low or Intermediate Risk Myelodysplastic Syndromes.¿
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-10-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will evaluate the efficacy and safety of a combination of NeoRecormon, CellCept and prednisone in patients with low or moderate risk myelodysplastic syndromes (MDS). In the first phase of the study, patients will receive CellCept (1g p.o. twice daily) plus prednisone. After 3 months, if patients have not responded to treatment, NeoRecormon (30000 IU/week, s.c.) will be added to the treatment regimen. If there is no response to NeoRecormon after 6 weeks, the dose will be increased to 60000 IU/week. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* diagnosis of MDS, according to International Prognostic Scoring System (IPSS) criteria;
* low or intermediate risk, who are not candidates for treatment with growth factors, or who have not responded to these treatments.

Exclusion Criteria:

* previous treatment with CellCept, or any erythropoietin-stimulating drug;
* diagnosis of proliferative chronic myelomonocytic leukemia;
* prior or concomitant malignancies other than MDS, with the exception of basocellular, spinocellular or adequately treated in situ cervical cancer, in the past 3 years;
* biological antitumor and myelosuppressive treatment within 28 days before start of study;
* bone marrow precursor cell transplantation previous to study.

Primary outcomes:
measure: Percentage of Participants With Clinical Response as Measured by the International Working Group (IWG) Criteria for Hematological Improvement
timeFrame: Up to approximately 2 years
measure: Mean Number of Blood Transfusions Per Visit
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Percentage of Participants With at Least One Adverse Event (AE)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Barakaldo
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cádiz
country: Spain
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01418391: the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial
Official title: the Effect of the Transversus Abdominis Plane (TAP) Block on the Minimal Laparotomy : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Keywords: minimal laparotomy
TAP block
morphine consumption
post-operative analgesia
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2011-08-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Transversus abdominis plane block (TAP block) is a new regional block for abdominal wall.It had been reported the effect of post-operative pain control in minor abdominal surgery, such as inguinal hernia repair and appendectomy. On the other hand, because of the accurate of the pre-operative images, the minimal laparotomy for colon cancer was accomplished. Thus, the purpose of this study is to investigate the effect, such as analgesic effect, hemodynamic stability, and post-operative morphine consumption, of TAP block in minimal laparotomy.

Detailed description: outcome measures:

* Hemodynamic parameters (mean artery pressure, heart rate): recorded at time points of before induction of general anesthesia (baseline), after tracheal intubation immediately, after surgery started 1, 2, 3, 4, 5, 10, 15, 20, 25, and 30 min; then recorded them every 10 mins.
* Post-operative morphine consumption: recorded morphine consumption at the time intervals of post-operative 0\~6 h, 6\~12 h, 12\~24 h, 24\~36 h, and 36\~48 h ,respectively. The total amount of morphine consumption was also counted.

Eligibility criteria: Inclusion Criteria:

* Anesthesiologists physical status I-III, ≧ 18 years of age, and needed double-lumen endotracheal tube (DLT) for thoracic surger

Exclusion Criteria:

* increased risk for regurgitation and pulmonary aspiration, history of gastroesophageal reflux, and pregnancy
* a tracheostomy or prolonged ventilation on ICU was planned, patients were also excluded

Primary outcomes:
measure: amount of post-operative morphine consumption
timeFrame: post-operative 48 hours
Secondary outcomes:
measure: evaluation of post-operative pain status using visual analog scale (VAS) and superimposed face pain severity scale
timeFrame: post-operative 48 hours
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: department of anesthesia, Kaohsiung medical university memorial hospital
Study officials:
affiliation: Department of anesthesia, Kaoshiung medical university hospital
name: Hung-Te Hsu, VS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00941291: Outcome of Idiopathic Macular Hole
Official title: Long-term Outcome of Idiopathic Macular Hole Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Macular Hole
Keywords: idiopathic macular hole
cataract
edema
Reopening
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2009-07-17
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred and thirty patients (135 eyes) with stage 2, 3, or 4 IMH were included after successful IMH repair

Brief summary: The purpose of this study is to evaluate the role of cataract surgery and cystoid macular edema (CME) on reopening of idiopathic macular holes (IMH).


Eligibility criteria: Inclusion Criteria:

* Patients with with stage 2, 3, or 4 Idiopathic Macular Hole after successful Idiopathic Macular Hole repair

Exclusion Criteria:

* All patients without stage 2, 3, or 4 Idiopathic Macular Hole repair

Primary outcomes:
measure: Long-term outcome of idiopathic macular hole surgery
timeFrame: 37 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Ophthalmology Unit CHU Dijon
state: Burgundy
Study officials:
affiliation: Ophthalmology unit CHU Dijon
name: Catherine Creuzot-Gracher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Passemard M, Yakoubi Y, Muselier A, Hubert I, Guillaubey A, Bron AM, Berrod JP, Creuzot-Garcher C. Long-term outcome of idiopathic macular hole surgery. Am J Ophthalmol. 2010 Jan;149(1):120-6. doi: 10.1016/j.ajo.2009.08.003. Epub 2009 Oct 20.
Clinical trial NCT02590991: Follow-up Study to Investigate Long Term Effect of Supplementing Pre- and Probiotics in Children Born by C-Section
Official title: A Follow-up Clinical Study to Investigate the Long Term Effect of Supplementation of Pre- and Probiotics in Early Life in Children Born by Caesarean Section (Julius SN Follow-up 1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caesarean Section Born Children
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-29
Enrollment: 102
Sex: ALL
Minimum age (years): 36
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who had completed Juliu Sn study until 16 weeks of age.

Brief summary: This study investigate the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section.

Detailed description: This is an extension of investigation on the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section from an earlier completed study.

Eligibility criteria: Inclusion Criteria:

* Participation in the Julius SN study until 16 weeks of age
* Written informed consent from parent(s) or legally acceptable representatives

Exclusion Criteria:

* Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements.

Primary outcomes:
measure: Absolute count of Bifidobacterium
timeFrame: 3 - 4 years old
measure: Absolute level of fecal lactate
timeFrame: 3 - 4 years old
measure: Incidence of allergy manifestation
timeFrame: 3 - 4 years old
measure: Incidence of gastrointestinal symptoms
timeFrame: 3 - 4 years old
measure: Incidence of infection
timeFrame: 3 - 4 years old
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Mei Chien Chua, Dr
role: PRINCIPAL_INVESTIGATOR
References: