louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05671328: Incidence of Invasive Pulmonary Aspergillosis in Ventilator-associated Pneumonia
Official title: Evaluation of the Incidence of Invasive Pulmonary Aspergillosis in Patients With Suspected Ventilator-associated Pneumonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator Associated Pneumonia
Pulmonary Aspergillosis Invasive
Keywords: Pulmonary invasive aspergillosis
ventilator-associated-pneumonia
mechanical ventilation
nosocomial infections
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2023-01-04
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in ICU

Brief summary: Mechanically ventilated patients are at risk of developing ventilator-associated pneumonia (VAP). Invasive pulmonary aspergillosis (IPA), the diagnosis of which motivates the implementation of specific treatments, is one of the causes of VAP. The hypothesis of the study is that the incidence of IPA is 12.4%. For each patient presenting with a suspicion of VAP and requiring a bronchoalveolar lavage (BAL), the diagnosis of API will be evaluated by biological examinations performed on blood and BAL. Medical and surgical history as well as clinical and biological data will be collected for 28 days or until discharge from the ICU.


Eligibility criteria: Inclusion Criteria:

* Adult patient (age ≥ 18 years),
* On invasive ventilation for more than 48 hours,
* Suspected VAP, defined by the appearance or worsening of a radiological pulmonary infiltrate, associated with 2 of the following clinical criteria:

  * Fever ≥ 38° C or hypothermia ≤ 36.5° C
  * Leukocytes \> 12x109 or \< 4x109/L
  * Purulent tracheal secretions

Exclusion Criteria:

* Neutropenic patients (neutrophils \< 0.5G/L),
* Previous diagnosis of IPA,
* Minor patients.

Primary outcomes:
measure: Incidence of probable or proven IPA according to the Verweij criteria in patients with suspected VAP
timeFrame: On the 1 day of inclusion
Secondary outcomes:
measure: Incidence of IPA according to the Blot criteria
timeFrame: On the 1 day of inclusion
measure: Incidence of Aspergillus tracheobronchitis associated with IPA according to the Verweij criteria
timeFrame: On the 1 day of inclusion
measure: Incidence of IPA according to the Verweij criteria in the subgroup without risk factors.
timeFrame: On the 1 day of inclusion
measure: Mortality
timeFrame: at 28 days
measure: Length of stay in intensive care unit
timeFrame: Until discharge from the ICU, an average 28 days
measure: Duration of mechanical ventilation
timeFrame: Until discharge from the ICU, an average 28 days
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Saad NSEIR, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00285428: Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma
Official title: A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Hodgkin's Lymphoma
Keywords: treatment
NHL
CD20+ B-cell NHL
Lymphoma
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2006-02-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I trial to look at safety and how a patient's body will tolerate the treatment at different dosages.


Eligibility criteria: Inclusion Criteria:

* CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease

Primary outcomes:
measure: Safety and tolerance of different dose levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Lack of immunogenicity
timeFrame: 8 and 12 weeks
measure: Pharmacodynamics
timeFrame: over 12 weeks
measure: Pharmacokinetics
timeFrame: over 12 weeks
measure: Efficacy
timeFrame: 4, 8 and 12 wks, every 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital/Cornell Medical Center
state: New York
city: Philadelphia
country: United States
facility: University Hospital of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Gilead Sciences
name: William Wegener, MD, PhD
role: STUDY_CHAIR
References:
citation: Goldenberg DM, Morschhauser F, Wegener WA. Veltuzumab (humanized anti-CD20 monoclonal antibody): characterization, current clinical results, and future prospects. Leuk Lymphoma. 2010 May;51(5):747-55. doi: 10.3109/10428191003672123.
citation: Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon MO, Coleman M, Schuster SJ, Dyer MJ, Horne H, Teoh N, Wegener WA, Goldenberg DM. Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results. J Clin Oncol. 2009 Jul 10;27(20):3346-53. doi: 10.1200/JCO.2008.19.9117. Epub 2009 May 18.
Clinical trial NCT01149161: Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
Official title: Sentinel Lymph Node Biopsy in the Thyroid Carcinoma; Randomized, Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Carcinoma
Keywords: neck dissection
sentinel lymph node
Carcinoma
Papillary
thyroid
dissection
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-06-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study. The investigators started this study from May of 2009 and this study will be continued until Dec. 2011.

Detailed description: The investigators will assign all patients to three groups; no dissection group (Group I), sentinel lymph node biopsy only group (Group II) and routine central neck dissection group (Group III). At first, to know the necessity of routine central neck node dissection for micro PTC,the investigators will compare the result of group I and group III. Additionally, the investigators can analyze the usefulness of sentinel lymph node biopsy for substitution of routine central neck node dissection for micro PTC.

Eligibility criteria: Inclusion Criteria:

* papillary carcinoma of thyroid (less than 4cm)
* no evidence of lymph node metastasis in preoperative work-up result
* the patients who accept this study

Exclusion Criteria:

* large thyroid cancer( \> 4cm)
* morbid
* anticoagulation agent usage
* endoscopic or robotic thyroid operation
* evidence of lymph node metastasis or extrathyroidal extension in preoperative US and CT scan

Primary outcomes:
measure: Is routine neck node dissection necessary in micro PTC?
timeFrame: Until 5 year follow-up. (Dec. 2016)
Secondary outcomes:
measure: The efficacy of sentinel lymph node biopsy in micro PTC
timeFrame: Until 5 year follow-up. (Dec. 2016)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jee Soo Kim, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01476761: MicroCutter in Surgical Stapling - European Trial I
Official title: The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thoracic
Keywords: Surgical tissue resection
Tissue dissection
Tissue transection
Anastomosis of gastrointestina tissue
Lead sponsor: Cardica, Inc
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety of the Microcutter stapling /cutting device in patients requiring the transection, resection or anastomosis of gastrointestinal tissue in a post-market approval study.

Detailed description: A prospective, open label, multi-center non-inferiority safety study with an all-comers enrollment of patients requiring surgical stapling of the stomach and/or intestine according to the labeled indications contained in the approved labeling. Up to 178 subjects consented for a 1-month clinical follow-up evaluation will be enrolled. Primary endpoint is to statistical non-inferiority of composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) in study patients when compared to composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) as derived from a comprehensive analysis of the medical literature. The comparison will be performed for cumulative events up to 30 days postoperatively.

Eligibility criteria: Inclusion Criteria:

- All patients requiring surgical treatment where the use of a surgical stapler is anticipated

Exclusion Criteria:

- None

Primary outcomes:
measure: Composite adverse event rate
timeFrame: up to 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: DRK-Krankenahus Clementinenhaus
Study officials:
affiliation: DRK-Krankenhaus Clementinenhaud, Hannover
name: Andreas Kithe, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01198561: Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression
Official title: Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression : Effect of TMS on Depression, Cognitive Function, and Regional Cerebral Glucose Metabolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depressive Disorder
Keywords: repetitive Transcranial Magnetic Stimulation
Major Depressive Disorder
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with major depressive disorder, who were not responsive to antidepressants

Brief summary: The objective of this study is to investigate the antidepressant efficacy of rTMS, and to assess cortical metabolism before and after rTMS sessions in patients with major depression. We also aimed to investigate differences between the responders and nonresponders to rTMS and what would predict clinical response to rTMS.

Detailed description: The specific aims of this study is to: (1) evaluate the antidepressant efficacy of rTMS on major depression; (2) evaluate the effects of rTMS on cognitive function in depressive patients; (3) assess the effects of rTMS on cerebral glucose metabolism in depressive patients as measured by 18FDG PET; (4) investigate the differences of the regional cerebral glucose uptake changes during rTMS between responders and nonresponders to rTMS.

Eligibility criteria: Inclusion Criteria:

* Twenty patients fulfilling the diagnostic criteria of major depression according to DSM IV will be enrolled in the study.
* Antidepressant medication will be maintained throughout the study period.

Exclusion Criteria:

* Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.
* To exclude the effect of drug changes on post-rTMS cerebral glucose metabolism, the combinations and dosage of pre-rTMS antidepressant drugs will remain unchanged until the post-rTMS 18FDG PET is done.

Primary outcomes:
measure: Hamilton depression rating scale (HAM-D 17)
timeFrame: baseline, 1, 2, and 4 weeks after TMS
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Kangnam-Ku
Study officials:
affiliation: Samsung Medical Center
name: Doh K KIm, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04882761: Socket Shield With Immediate Implant Stability
Official title: Evaluation of Soft Tissue Stability and Labial Plate of Bone of Immediate Implant in Direct Contact Versus Gap With Socket Shield (A Randomized Clinical Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Implant
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate socket shield technique either placing implant in direct contact to tooth fragment versus gap created between the tooth and implant.

Detailed description: Patients with a non-restorable tooth located in anterior maxillary arch was included in this study, patients were divided into two groups, eight implants per group, both groups had socket shield, group 1 will have implant in direct contact with shield, second group had a gap between dental implant and shield. soft tissue stability, bone width and implant stability was assessed preoperatively, immediate and 6 months postoperative.

Eligibility criteria: Inclusion Criteria:

1. Patients with a non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar). Tooth to be extracted is endodontically treated and free from periapical infection.
2. Systemic free patients according to modified Cornell medical index (Brodmank and Erdmann 1949).
3. Patients with good compliance.

Exclusion Criteria:

1. Teeth with current acute periapical infection or sinus tracts.
2. Heavy smokers and patients with bruxism habits.
3. Patients with poor oral hygiene or not willing to perform oral hygiene measures.
4. Vulnerable groups (as pregnant females and decisionally impaired individuals).

Primary outcomes:
measure: Soft tissue stability
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Bone stability
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Doaa Khattab
state: Abbassia
Study officials:
affiliation: Ain Shams University
name: Doaa Adel-Khattab, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01024361: Cpap at Delivery Room for Preterm Infants
Official title: CPAP Application at Delivery Room at Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mechanical Ventilation
Retinal Disease
Death
Respiratory Tract Disease
Keywords: Preterm infants
Nasal CPAP
Delivery room
Newborn
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2009-12-02
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to determine if CPAP applied within less than 15 min of life in the DR reduces the necessity of mechanical ventilation and surfactant during the first 5 days of life.

Detailed description: A multicenter prospective cohort of inborn preterm infants, born at 8 public university NICU in Brazil, with birthweight 1000-1499 g, without malformations, not intubated at 15 minutes of life. Preterm infants will be randomly assigned at birth to an early treatment group (DR-CPAP), in which CPAP of 5 cm water pressure is applied within 15 minutes after birth by Neopuff, or to a routine group (RG), in which CPAP is applied when indicated by the assistant physician. After transfer to the NICU, nasal CPAP will be maintained with Hudson prongs

Eligibility criteria: Inclusion Criteria:Inborn.

* Birth weight 1000g to 1500g
* No major malformations

Exclusion Criteria:

* Necessity of intubation
* Maternal decision

Primary outcomes:
measure: Necessity of mechanical ventilation and surfactant during the first 5 days of life
timeFrame: 5 days
Secondary outcomes:
measure: Maternal and infant characteristics associated with CPAP failure during the first 15 minutes of life
timeFrame: 15 minutes
measure: Incidence of pneumothorax, interstitial emphysema, ductus arteriosus, peri- intra-ventricular hemorrhage, sepsis, necrotizing enterocolitis
timeFrame: 30 days
measure: Oxygen use
timeFrame: 28 days
measure: Oxygen use
timeFrame: 56 days
measure: Oxygen use
timeFrame: 36 weeks of corrected age
measure: Retinopathies of prematurity
timeFrame: Hospital stay
measure: Death during hospitalization
timeFrame: Hospital stay
Other outcomes:
Locations:
Study officials:
affiliation: University of sao Paulo at Ribeirão Preto
name: Francisco E Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00265161: The Effectiveness of Influenza Vaccine Among Health Care Workers in a Hospital Setting.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Vaccines
Keywords: influenza vaccine
effectiveness
health care worker
OBSERVATIONAL STUDY
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2005-12-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The study will be held in the winter of 2005-2007. The aim is to assess the effectiveness of the influenza vaccine in health care workers (HCW).

Detailed description: The study will be held in the winter of 2005-2006. Groups of vaccinated HCW and not vaccinated HCW will be followed for symptoms suggestive of influenza. For each event a quick through test for influenza A or B will be done and if positive will be confirmed by viral study. Data regarding days of illness, absence from work, therapy etc., will be collected. Effectiveness will be calculated as well as cost/effectiveness of vaccination.

Eligibility criteria: Inclusion Criteria:

* Previously healthy health care worker vaccinated or not

Exclusion Criteria:

* Immunocompromised state

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Dpt A', HaEmek Medical Center
Study officials:
affiliation: HaEmek Medicak Center, Afula, Israel
name: Dan Miron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05977361: Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients
Official title: Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Analgesia, Obstetrical
Post-Dural Puncture Headache
Keywords: Labor Pain
Obstetric Labor Complications
Analgesia, Epidural
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 181
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epidural anesthesia represents the most popular method for pain relief during labour. Unintentional dural puncture (UDP) occurs in 0.4-1.5% of labour epidural analgesia, representing therefore the most common complication. Up to 80% of patients with a UDP may develop a post-dural puncture headache (PDPH).

When a UDP occurs, two possible strategies have been proposed in order to ensure analgesia during labour: either resiting the epidural catheter in a different intervertebral space, or inserting an intrathecal catheter. Both strategies proved to equally provide analgesia during labour, but their relative contribution in preventing PDPH is still not known.

The primary aim of this multicenter randomized controlled trial is therefore to compare these two strategies in the occurrence of PDPH at 24 hours from the UDP.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of UDP during labour
* Written informed consent

Exclusion Criteria:

* Refusal to participate in the study
* History of PDPH

Primary outcomes:
measure: PDPH incidence
timeFrame: At 24 hours from UDP
Secondary outcomes:
measure: PDPH intensity at 24 hours
timeFrame: At 24 hours from UDP
measure: PDPH intensity at 48 hours
timeFrame: At 48 hours from UDP
measure: Quality of analgesia
timeFrame: During the entire course of labour, an average of 12 hours
measure: Adverse events
timeFrame: During the entire follow-up period, up to 3 months from UDP
measure: Chronic pain at 1 month
timeFrame: At 1 month from UDP
measure: Chronic pain at 3 months
timeFrame: At 3 months from UDP
measure: Readmission to hospital
timeFrame: Up to 3 months from UDP
measure: Patient's satisfaction
timeFrame: Before discharge, an average of 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01137461: Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Oocytes Recipients
Official title: Evaluation of Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Recipients of Oocytes. A Single-centre, Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: Female infertility with indication of oocyte reception
Lead sponsor: Fundació Privada Eugin
Sponsor class: OTHER
First posted: 2010-06-04
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy of embryo transfer procedure guided by transvaginal ultrasound versus abdominal ultrasound in recipients of oocytes as well as the advantages and disadvantages of the new technique.


Eligibility criteria: Inclusion Criteria:

* Oocyte recipients.
* Uterus without previously detected anomalies.
* Patients able to understand the study requirements who want to participate during all its duration and that have signed the informed consent.

Exclusion Criteria:

* Turner syndrome, Black race (significantly lower implantational rates)

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 40 days after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clinica EUGIN
Study officials:
affiliation: Clinica EUGIN
name: Daniel Bodri
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bodri D, Colodron M, Garcia D, Obradors A, Vernaeve V, Coll O. Transvaginal versus transabdominal ultrasound guidance for embryo transfer in donor oocyte recipients: a randomized clinical trial. Fertil Steril. 2011 Jun;95(7):2263-8, 2268.e1. doi: 10.1016/j.fertnstert.2011.03.028. Epub 2011 Apr 2.