louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02681159: Critical Incidents Related to Anesthesia and Intensive Care: A Study in a Tertiary Hospital
Official title: Critical Incidents Related to Anesthesia and Intensive Care: A Prospective Study in a Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Incident
Keywords: Anesthesia
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who undergo anesthesia and surgery and be exposed to a critical incidence.

Brief summary: Critical incidents in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients. Most of the studies in this regards are retrospective with many drawbacks and pitfalls like absence of information in the records of the patients.

In the investigators' study, the investigators will follow the critical incidents among patients who underwent surgery under anesthesia whether regional or general over the next two years from 2016 to 2018, by examining the patients records from the hospital database and recording the events that occur to the patients.

Detailed description: Over the forthcoming two years, the investigators will study in details critical incidences that may occur to patients in the perioperative period like; acute hypoxic event, acute major hemorrhage, acute airway obstruction and others that may endanger the life or one of the patient organs and whether the patient survive the acute event or die.

These critical incidences will be collected and all information about it will be known in order to be studied and to know were was the defect and eventually to improve the safety of practice of anesthesia and surgery.

Eligibility criteria: Inclusion Criteria:

* patients who undergo anesthesia and surgery
* patients who are exposed to a critical incidence

Exclusion Criteria:

* patients who undergo anesthesia and surgery and do not expose to critical incidents.

Primary outcomes:
measure: number of anesthetized patients who have perioperative critical incidence.
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
affiliation: University of Jordan
name: Subhi M Alghanem, FFARCS
role: STUDY_CHAIR
References:
citation: Munting KE, van Zaane B, Schouten AN, van Wolfswinkel L, de Graaff JC. Reporting critical incidents in a tertiary hospital: a historical cohort study of 110,310 procedures. Can J Anaesth. 2015 Dec;62(12):1248-58. doi: 10.1007/s12630-015-0492-y. Epub 2015 Sep 25.
Clinical trial NCT05612659: Developing an EEG Probe for Studying and Modulating Cognitive Control
Official title: Developing an EEG Probe for Studying Effects of Non-invasive Cortical and Spinal Cord Electrical Stimulation on Cognitive Control in Post Stroke Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Depression
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate effects of transcranial current stimulation (tES) and transcutaneous direct current stimulation (tsDCS) associated changes on fronto-parietal EEG and cognitive performance in patients with post stroke depression (PSD)

Detailed description: The investigators will perform a double blind, randomized, sham controlled, crossover study design to assess effects of tES, tsDCS and sham stimulation on the performance during a cognitive control task. The working Hypothesis is tsDCS and/or tES will enhance frontal theta oscillations as recorded on EEGs and improve task performance compared to sham stimulation.

Results from this project can potentially lead to the development of a new research tool for assessing neuromodulation strategies to treat mental disorders and their comorbidities. It will also uncover the neural correlates of cognitive deficits in PSD and provide feasible biomarkers associated with treatment response in support of a larger clinical.

Eligibility criteria: Inclusion Criteria:

1. Subjects will include both male and female of age over 18 years and a BMI of 18-35 Kg/mts2 who have experienced stroke.
2. Moderately depressed, MADRS:18-28, PHQ9: 10-20 and/or experiencing cognitive impairments after stroke

Exclusion Criteria:

1. Current or lifetime bipolar disorder or schizophrenia diagnosis;
2. current (past month): PTSD, psychotic or substance use disorder (nicotine and caffeine allowed);
3. significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year:
4. current chronic severe pain conditions;
5. current chronic use of: opioids analgesics, medications that affect blood pressure or drugs with significant autonomic effects (stimulants and antipsychotics allowed if dose stable for 1 month);
6. skin lesions on electrode placement region;
7. implanted electrical medical devices;
8. Pregnancy;
9. suspected IQ\<80, and 10) any other clinically relevant reason as judged by the clinician.

Primary outcomes:
measure: EEG oscillations
timeFrame: change from baseline
Secondary outcomes:
measure: Behavior
timeFrame: during procedure
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
References:
Clinical trial NCT05166759: Incidence and Clinical Characteristics of Pulmonary Hypertension Secondary to ARDS in the Highland
Official title: Incidence and Clinical Characteristics of Pulmonary Hypertension Secondary to ARDS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Qinghai University
First posted: 2021-12-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is conducted in the affiliated hospital of Qinghai University .Patients in the department of Critical Care Medicine and Emergency Intensive Care Unit will be eligible for inclusion if they meet the Berlin criteria.Two researchers assess pulmonary artery pressure and right heart function of patients who are enrolled.

Brief summary: The study is conducted in the affiliated hospital of Qinghai University .Patients in the department of Critical Care Medicine and Emergency Intensive Care Unit will be eligible for inclusion if they meet the Berlin criteria.Two researchers assess pulmonary artery pressure and right heart function of patients who are enrolled.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

18 to 80 years of age Meet the diagnostic criteria Receive invasive mechanical ventilation within 48 hours

-

Exclusion Criteria:

Patients with those disease will be excluded ： chronic obstructive pulmonary disease Pulmonary embolism Chronic heart failure Idiopathic pulmonary fibrosis Pulmonary hypertension Pregnant women will be excluded too.

-

Primary outcomes:
measure: Incidence of Pulmonary Hypertension Secondary to ARDS in the Highland
timeFrame: 20/11/2021-20/12/2022
measure: ICU mortality ICU mortality
timeFrame: 20/11/2021-20/12/2022
measure: 28-days mortality rate
timeFrame: 20/11/2021-20/12/2022
Secondary outcomes:
measure: Ventilator time
timeFrame: 20/11/2021-20/12/2022
measure: Hospital length of stay
timeFrame: 20/11/2021-20/12/2022
Other outcomes:
measure: Right cardiac functionof Pulmonary Hypertension Secondary to ARDS in the Highland
timeFrame: 20/11/2021-20/12/2022
Locations:
city: Xining
country: China
facility: Affiliated Hospital of QingHai University
state: Qinghai
Study officials:
affiliation: Qinghai University
name: Chun Pan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00436059: The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)
Official title: The Efficacy of Velcade on Bone Tissue During Myelomatosis (Bone Marrow Cancer)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2007-02-16
Enrollment: 20
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: The primary objective of the the study is to investigate the changes in bone remodeling during Velcade treatment.

Detailed description: 20 patients will be included in the study over a 2 year period. Before, during and after treatment we will measure NTX-I, CTX-I, CTX-MMP, bALP, DKK-1, PINP, TRAcP and PTH. NTX, CTX and CTX-MMP are measured to estimate bone degradation. TRAcP is measured to estimate the activity of the osteoclasts. bALP and DKK-1 is measured to evaluate the activity of the osteoblasts and PINP is measured as a marker of new bone formation. PTH is measured in order to evaluate if the positive effects that is observed in bone formation in relations to velcade treatment is due to the pulsative way velcade is administered.

The effect of the velcade treatment will be evaluated by x-ray, bone marrow and m-component.

Eligibility criteria: Inclusion Criteria:

* Previously untreated multiple myeloma

Exclusion Criteria:

* Use of bisfosfonates

Primary outcomes:
measure: Changes in bone markers during treatment
Secondary outcomes:
measure: Changes in osteolysis during treatment
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University Hospital Odense
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Vejle Hospital
name: Torben Plesner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05620459: Anterior Maxilla Augmentation Using Chin Bone Ring With Implant Placement
Official title: Computer Guided Simultaneous Implant Placement With Ridge Augmentation Using Autogenous Bone Ring Transplant in Defective Maxillary Anterior Sockets
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ridge Augmentation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims toward using autogenous bone grafts to solve decreased bone quantity in anterior maxilla while allowing the patient to recieve implants simultaneously (same time of grafting).

Detailed description: * Chin bone ring will be harvested from patient's(10 in number) chin to augment the recent extraction socket with buccal bone defect, followed by implant placement.
* The process of harvesting and placement of ring will be computer guided which adds lots of accuracy to the bone ring required size from the donor site and the proper placement of both the ring and the implant at the recipient site

Eligibility criteria: Inclusion Criteria:

* Patients with non-restorable teeth in the maxillary anterior region with insufficient buccal bone height or buccal bone defect.
* Patients who have given their consent for this trial.
* Both genders males and females will be included.

Exclusion Criteria:

* • Untreated periodontitis.

  * Poor oral hygiene and motivation.
  * Uncontrolled diabetes.
  * Pregnant or nursing.

Primary outcomes:
measure: Bone quantity (crestal bone) height)
timeFrame: 3 months after operation day
Secondary outcomes:
measure: Bone quality (bone density at the ring alveolus interface)
timeFrame: 3 months after operation day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: cairo University
state: cairo/Manial
Study officials:
affiliation: Cairo University
name: Mostafa M gad, bds
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yuce MO, Adali E, Turk G, Isik G, Gunbay T. Three-dimensional bone grafting in dental implantology using autogenous bone ring transplant: Clinical outcomes of a one-stage technique. Niger J Clin Pract. 2019 Jul;22(7):977-981. doi: 10.4103/njcp.njcp_652_18.
citation: Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.
citation: Simpson KT, Bryington M, Agusto M, Harper M, Salman A, Schincaglia GP. Computer-Guided Surgery Using Human Allogenic Bone Ring With Simultaneous Implant Placement: A Case Report. Clin Adv Periodontics. 2020 Mar;10(1):16-22. doi: 10.1002/cap.10073. Epub 2019 Oct 14.
citation: Stevens MR, Emam HA, Alaily ME, Sharawy M. Implant bone rings. One-stage three-dimensional bone transplant technique: a case report. J Oral Implantol. 2010;36(1):69-74. doi: 10.1563/AAID-JOI-D-09-00029.
Clinical trial NCT02768259: Prevalence of Pulmonary Arterial Hypertension in Patients With Connective Tissue Diseases in Egyptian Patients
Official title: Prevalence of Pulmonary Arterial Hypertension in Patients With Connective Tissue in Egyptian Patients ( Single Center Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Connective Tissue Diseases
Pulmonary Hypertension
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed as connective tissue diseases fulfilling ACR criteria will be recruited

Brief summary: * Measuring the incidence and prevalence of PAH in Egyptian patients with different types of MCD
* Determination of survival \& the risk factors of mortality.

Detailed description: PH is defined as a mean pulmonary artery pressure greater than 25 mmHg. PAH can be assessed by different means, however right heart catheterization (RHC) is the gold standard diagnostic method .

Among the different subgroups of pulmonary arterial hypertension (PAH), those associated with connective tissue diseases (CTDs) are a specific entity with distinct hemodynamic and prognostic features reflecting the importance of a rheumatological assessment in PAH, especially with the unfavorable prognostic impact in these patients.

Compared to patients with idiopathic PAH, patients with CTD-associated PAH have a higher mortality and a lower walking distance on the 6-minute walk test, higher levels of B-type natriuretic peptide, worse right ventricular function, more left-sided heart dysfunction, lower lung function, and more pericardial disease.

That's why, PAH screening is routinely performed in systemic sclerosis (SSc) and in other CTDs and also, as suggested by international guidelines, it is important to rule out CTDs in patients with PAH, because patients diagnosed as idiopathic PAH (iPAH) may have an associated CTD previously unrecognized.

Although the similarities in pathogenesis of PAH in CTD such as systemic sclerosis (SSc), systemic lupus erythematosus (SLE), and mixed connective tissue disease (MCTD), there are variabilities in outcomes in patients with CTD-associated PAH.

Eligibility criteria: Inclusion Criteria:

- Patients diagnosed as connective tissue diseases fulfilling ACR criteria will be recruited

Exclusion Criteria:

non

-

Primary outcomes:
measure: prevalence
timeFrame: 1 year
Secondary outcomes:
measure: Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alaini School of Medicine
Study officials:
affiliation: Professor of pulmonary Medicine ,Cairo University
name: Mostafa I Elshazly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05915559: Outpatient Management of Tonsillectomy in Adults
Official title: Outpatient Management of Tonsillectomy in Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tonsillectomy
Pain
Ambulatory
Keywords: Tonsillectomy
Pain
ambulatory
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Tonsillectomy is a frequent surgical procedure in the ENT specialty but it can be a source of postoperative pain that can be important. These pains complicate the intake of food and in particular the intake of analgesic drugs per os and require the prolongation of the hospitalization in order to continue an intravenous analgesia. The aim is to set up a protocol for ambulatory care of adult tonsillectomies. Then, it would allow an improvement of the postoperative quality of life for the patient, who prefers a quicker return home.The study aims to allow patients to come back home early after tonsillectomies with intravenous analgesia. Pain, feeding and quality of life will be evaluated regularly through an application called MAELA during a few days after surgery. They will also be evaluated by nurses coming via providers.


Eligibility criteria: Inclusion Criteria:

* Indication for a tonsillectomy defined in the French recommendations
* Age between 18 and 60 yo
* Providing free and informed consent to participate
* Having a smartphone able to process MAELA application
* Affiliation to french social security

Primary outcomes:
measure: Number of patients EVA score less or equal at 3
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT02595359: Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
Official title: Intracameral Moxifloxacin for Prevention of Postcataract Endophthalmitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endophthalmitis
Keywords: endophthalmitis
antibiotic therapy
cataract surgery
prevention
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.

Detailed description: Although cataract surgery is generally considered a safe procedure resulting in a favourable visual outcome, surgical complications do occur. The most feared complication is postoperative endophthalmitis which is an infectious condition caused by micro-organisms introduced to the interior of the eye during or after the surgical procedure.

As endophthalmitis is an infection, it should be preventable by antibiotic treatment.

Prophylactic antibiotic treatment can be given as topical treatment preoperatively, or during surgery directly into the anterior chamber, or as a subconjunctival, or it can be given as topical treatment postoperatively.

The aim of this study was to evaluate the efficacy and safety of the prophylactic effect of intracameral moxifloxacin for prevention of postcataract endophthalmitis.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of visually significant cataract

Exclusion Criteria:

* Has known allergies to moxifloxacin
* Has significant ocular co-morbidities in one or both eyes which may include (but is not limited to): advanced glaucoma, advanced or active macular degeneration, Fuchs corneal dystrophy, prior corneal transplantation, advanced diabetic eye disease, history of retinal detachment or any patient that would require billing a complex cataract procedure for any reason
* Has a known history of a condition which causes an immuno-compromised host state

Primary outcomes:
measure: endothelial cell count
timeFrame: 6-month; 1 year; 2 years
Secondary outcomes:
measure: endophthalmitis incidence
timeFrame: 1 month
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: UFPE Ophthalmology
state: PE
Study officials:
affiliation: Prof
name: Rodrigo Lira
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05762159: Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry
Official title: Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Local
Keywords: spinal erector block
pupillometry
loco-regional anesthesia
osteosynthesis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 30
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 receiving erector spinae block for pain management of spinal osteosynthesis will be included.

Brief summary: Few works have studied the area of analgesia covered by the spinal erector block in an objective manner, especially on the cephalo-caudal spread. The available data are dissection works or subjective data such as thermoalgesic or epicritic sensitivity.

This information would however be relevant in order to propose a better analgesia. Indeed, it could explain certain failures by insufficient diffusion of the block. The use of a multistage block could be relevant, especially in the case of osteosynthesis on several vertebral levels.

Detailed description: Pupillometry makes possible to monitor analgesia based on the pupillary dilation reflex to pain. The goal is to establish an objective mapping of these type of analgesia from these data.

Eligibility criteria: Inclusion Criteria:

* Patients receiving erector spinae block for pain management of spinal osteosynthesis

Exclusion Criteria:

* Patient refusal
* Known allergy to local anesthetics
* Contraindication to locoregional anesthesia (haemostasis disorder, infection, peripheral neuropathy)
* Technical impossibility to perform a spinal erector block
* Pathology with dysautonomia altering the pupillary reflex: diabetes mellitus with diabetic retinopathy, multiple sclerosis, systemic amyloidosis, uncontrolled hypertension, glaucoma
* Current treatment likely to alter pupillary dilation reflex to pain : antiemetic (droperidol, metoclopramide), alpha-2 agonist (clonidine)
* Serious psychiatric history
* Drug abuse
* Pregnancy

Primary outcomes:
measure: variation of the pupil size (in percentage)
timeFrame: During the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Maxime Wodey, MD
role: PRINCIPAL_INVESTIGATOR
References: