louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03582787: A Comparison of McGrath MAC Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children With Torticollis
Official title: Ajou University School of Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Endotracheal
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on the intubation time for orotracheal intubation in children with torticollis.

The secondary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children with torticollis.


Eligibility criteria: Inclusion Criteria:

* orotracheal intubation under general anesthesia
* torticollis

Exclusion Criteria:

* •oral lesions, congenital anomaly, cervical spine instability, rapid sequence intubation

Primary outcomes:
measure: Intubation time
timeFrame: through intubation completion, an average of 30 second
Secondary outcomes:
measure: The degree of glottic exposure as assessed by Cormack and Lehane Grade
timeFrame: Up to 5 second after laryngoscopy passing the teeth
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
state: Seoum
Study officials:
References:
Clinical trial NCT04094987: Interfascial Pressure Into Ultrasound Guided Anterior Quadratus Lumborum Block Application
Official title: Investigation of the Effect of Interfacial Pressure on Block Success During Anterior Quadratus Lumborum Block Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Block
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-09-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, cohort
Primary purpose: DIAGNOSTIC

Brief summary: The block has been shown to be the result of abdominal analgesia as a result of application between the quadratus lumborum (QL) muscle and the leaves in the thoracolumbar fascia.

In this block, local anesthetic drugs are administered between the quadratus lumborum (QL) muscle and the anterior leaf in the thoracolumbar fascia.

In this way, it has been reported that it provides a good analgesia as it relieves somatic pain better in upper and lower abdominal surgeries.

Detailed description: The mechanism of QLB analgesic contains many theories. This study includes the research relationship between the effect of fascial pressure and the success of the association block. We will use the ultrasound guided anterior Quadratus Lumborum Block. A peripheral nerve block catheter will be placed between the quadratus lumborum muscle and the psoas muscle with ultrasound.The pressure between the fascia and the pressure line added to the catheter tip will be measured.A peripheral nerve block catheter will be placed between the quadratus lumborum muscle and the psoas muscle with ultrasound. The pressure between the fascia and the pressure line added to the catheter tip will be measured.

Eligibility criteria: Inclusion Criteria:

Patients who were in the American Society of Anesthesiologists (ASA) I-III class

• Underwent laparoscopic cholecystectomy

Exclusion Criteria:

* Previous history of preoperative opioid use,
* Allergy to local anesthetics,
* The presence of any systemic infection,
* Uncontrolled arterial hypertension,
* Uncontrolled diabetes mellitus
* Presence of infection in the block area,

Primary outcomes:
measure: Interfascial Pressure (mm/hg)
timeFrame: 24 hours.
Secondary outcomes:
measure: sensory block level
timeFrame: peroperative 3 hours
measure: Visual Analog Scale
timeFrame: Postoperative 24 hours
measure: analgesic use
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Korgün Ökmen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03522493: The Effect of Age and Inspiratory Resistance on the Inspiratory Gas Levels While Wearing Air Purifying Respirator "
Official title: The Effect of Age and Inspiratory Resistance on the Inspiratory Gas Levels While Wearing Air Purifying Respirator "Yaalom Katom"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 20 healthy young subjects and 20 healthy older subjects will go through a medical examination. Subjects will be asked for their medical history especially on respiratory and cardiac diseases. All subjects will go through a spirometry test to evaluate their respiratory function. After their medical clearance each subjects will be asked to wear a CBRN respirator for 45 minutes. 15 minutes without filter, 15 minute with 0.8 cmH2O resistance, and 15 minutes with 1.2 cmH2O resistance. Throughout the test, Pco2 AND PO2 will be measured. The investigator will evaluate the effect of resistance (filter resistance) and the age of the subject on CO2 accumulation in the mask.

Detailed description: After signing the consent form, 20 healthy young subjects and 20 healthy older subjects will go through a medical examination. Subjects will be asked for their medical history especially on respiratory and cardiac diseases. All subjects will go through a spirometry test to evaluate their respiratory function. After their medical clearance each subjects will be asked to wear a CBRN respirator for 45 minutes. 15 minutes without filter, 15 minute with 0.8 cmH2O resistance, and 15 minutes with 1.2 cmH2O resistance. Throughout the test, Pco2 AND PO2 will be measured with mass spectrometer. Oxygen saturation, Pulse rate, and minute ventilation will also be monitored. The investigator will evaluate the effect of resistance (filter resistance) and the age of the subject on CO2 accumulation in the mask.

Eligibility criteria: Inclusion Criteria:

Healthy females and males, with no respiratory, cardio vascular diseases, high blood pressure, psychiatric problem, degenerative nervous system problem, and chronic head ache, muscular disease, or severe acute disease within the two weeks before the study. age 18 and 25, and 55 and 70 years old. Who volunteer to the study

-

Exclusion Criteria:

Did not pass the Inclusion criteria, pregnant women, O2 saturation lower then 95%, pathological sound from the heart or lungs. Claustrophobia, smoking history more then 2.5 packs years.

Primary outcomes:
measure: Average CO2 (%)
timeFrame: 45 minutes
Secondary outcomes:
measure: Respiratory discomfort (borg scale 1-10)
timeFrame: 45 minutes
measure: Average O2 (%)
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Israel Naval Medical Institute
Study officials:
References:
Clinical trial NCT05373771: Sickle Cell Improvement: Enhancing Care in the Emergency Department
Official title: Sickle Cell Improvement: Enhancing Care in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Crisis
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Pediatric Emergency Care Applied Research Network
name: Nemours Children's Health System
First posted: 2022-05-13
Enrollment: 5328
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Sickle cell disease (SCD) is an inherited blood disorder affecting approximately 36,000 children in the United States, approximately 90% of whom are Black. The disease is characterized by recurrent, severe pain crises which result in high rates of emergency department visits and hospitalizations, and decreased quality of life. The National Heart, Lung and Blood Institute, as well as the American Society of Hematology, have endorsed pain management guidelines regarding the timeliness of care for children presenting with these acute pain crises. These evidence-based guidelines are infrequently followed, resulting in increased pain and hospitalizations. In additional to other barriers to following the guideline, structural racism has been proposed as a significant contributor and the New England Journal of Medicine recently called for the institution of SCD-specific pain management protocols to combat structural racism and reduce time to opioid administration. The investigators' long-term goal is to improve the care and health outcomes of children with acute painful vaso-occlusive crisis treated in the emergency department. The overall aim of the investigators is to test a care pathway using multifaceted implementation strategies to increase guideline adherent care for children in the emergency department with acute painful vaso-occlusive crisis.


Eligibility criteria: Inclusion Criteria:

* ED visit for uncomplicated pain crisis
* Sickle cell disease
* Receipt of at least one opioid

Exclusion Criteria:

* Acute chest syndrome
* Fever \> 38.5 in the ED
* priapism
* sickle cell trait

Primary outcomes:
measure: Timeliness of receipt of opioids
timeFrame: A maximum of about 6 hours as all opioids received during the ED stay will be captured
Secondary outcomes:
measure: Median time to opioids
timeFrame: A maximum of about 6 hours as all opioids received during the ED stay will be captured
measure: Percent of children hospitalized
timeFrame: A maximum of about 6 hours as that is the typical maximum time to disposition for patients
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Wisconsin
state: Wisconsin
Study officials:
affiliation: Nemours Children's Health
name: David Brousseau, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00730093: The Absorption of Vitamin B12 Among Healthy Pregnant Women
Official title: The Absorption of Vitamin B12 Among Healthy Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Vitamin B12 absorption
Pregnancy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 27
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is crucial for the normal development af foetus during pregnancy.

In Denmark the National Board of Health recommend an intake of Folic Acid, from the day the woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation for vitamin B12. We will measure the vitamin B12 absorption with a new non-radioactive test, CobaSorb.

.


Eligibility criteria: Inclusion Criteria:

* the 13 week of gestation +/- 1 week (only fore pregnant women)
* Between 20- 40 years
* Northern European
* abel to read and understand danish

Exclusion Criteria:

* treatment with vitamin B12 within the last 5 years
* daily intake of vitamins that contain more than 1µg vitamin B12
* infectious disease
* systemic disease
* daily use of medicine that interferes with vitamin B12

Primary outcomes:
measure: Change in vitamin B12 absorption during pregnancy, measured with CobaSorb.
timeFrame: 9 month
Secondary outcomes:
Other outcomes:
Locations:
city: Skejby
country: Denmark
facility: Aarhus Universitetshospital, Skejby
state: Jylland
Study officials:
affiliation: Aarhus Universitetshospital, Aarhus Sygehus
name: Ebba Nexø, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04445493: EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic ( EPISODEPSCOVID )
Official title: EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
COVID-19
Lead sponsor: MindRhythm, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Wayne State University
name: Western Michigan University
First posted: 2020-06-24
Enrollment: 486
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 who are being evaluated in the prehospital environment by Detroit Paramedics/EMTs in whom stroke is suspected and who may be at risk fo COVID-19 infection

Brief summary: Prehospital providers encounter patients with suspected stroke frequently. Stroke and COVID-19 are related potentially putting these healthcare workers at risk of COVID-19 infection. In addition, prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers.

Detailed description: This observational prospective study will document COVID-19 status on patients seen in the prehospital environment for suspected stroke. This will provide an estimate of how frequently stroke occurs in stroke and also the exposure risk to providers in this setting.

Additionally, patients will have a headset placed to record their headpulse during the encounter. These measurements will be used to further develop an analytic model used to predict the presence of large vessel occlusion (LVO) stroke. This may help create a device that can be used in the prehospital environment to aid in the trade decision of destination hospital.

Eligibility criteria: Inclusion Criteria:

* suspected stroke in the prehospital setting
* patient at risk for COVID-19

Exclusion Criteria:

* scalp laceration
* Patient refusal
* Prisoner, other vulnerable population
* Prehospital provider feels that the recording may interfere with care

Primary outcomes:
measure: Prevalence of COVID-19 infection in suspected stroke population
timeFrame: Through Study Completion, an average of 6 months
measure: Quality head pulse recordings
timeFrame: Through Study Completion, an average 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University
name: James Paxton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith WS, Keenan KJ, Lovoi PA. A Unique Signature of Cardiac-Induced Cranial Forces During Acute Large Vessel Stroke and Development of a Predictive Model. Neurocrit Care. 2020 Aug;33(1):58-63. doi: 10.1007/s12028-019-00845-x.
Clinical trial NCT03669393: A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)
Official title: A Phase 2, Open-label, Multi-centre Study to Assess the Efficacy and Safety of Intravitreal THR-317 for the Treatment of Macular Telangiectasia Type 1 (MacTel 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Retinal Telangiectasis
Idiopathic Juxtafoveal Retinal Telangiectasia
Lead sponsor: Oxurion
Sponsor class: INDUSTRY
First posted: 2018-09-13
Enrollment: 8
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 study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in reducing central subfield thickness (CST) and improving best-corrected visual acuity (BCVA) in subjects with macular telangiectasia Type 1 (MacTel 1).


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years or older
* Macular oedema caused by MacTel 1, with CST \>300µm on SD-OCT
* Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

* Type 1 or type 2 Diabetes Mellitus
* Concurrent disease in the study eye that could require medical or surgical intervention during the study period for up to 30 days after the last study treatment, or could confound interpretation of the results
* Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment
* Any active ocular / intraocular infection or inflammation in either eye
* Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception

Primary outcomes:
measure: Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT)
timeFrame: At Day 84 (Month 3)
Secondary outcomes:
measure: Change from baseline in CST, based on SD-OCT, by study visit
timeFrame: From baseline to Day 140
measure: Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit
timeFrame: From baseline to Day 140
measure: Change from baseline in best-corrected visual acuity (BCVA), by study visit
timeFrame: From Day 0 to Day 140
measure: Incidence of systemic and ocular adverse events including serious adverse events
timeFrame: From Day 0 to Day 140
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Cochin
city: Lausanne
country: Switzerland
facility: Hôpital Ophtalmique Jules-Gonin
Study officials:
affiliation: Oxurion NV.
name: Clinical Department
role: STUDY_DIRECTOR
References:
Clinical trial NCT06256393: Inflammatory Bowel Disease Cohort in Nantes
Official title: Cohorte Nantaise de Maladies Inflammatoires Chroniques Intestinales
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Keywords: Crohn's disease
Ulcerative colitis
Cohort
Biocollection pathophysiology
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 360
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: IBD patients who are immunomodulator-naive or refractory to one or more lines of immunosuppressive, biotherapy, or small molecule therapy

Brief summary: The CELESTE cohort will be a three-center prospective cohort associated with the creation of a biobank including Inflammatory Bowel Diseases (IBD) patients with active disease

Detailed description: The CELESTE cohort will be a prospective cohort of IBD patients followed up at Nantes University Hospital, Jules Verne Clinic (Nantes) and/or Confluent Private Hospital (Nantes). The multicentric nature of the cohort including a tertiary referral center and two secondary care centers is a major asset, enabling the enrolment of a broad spectrum of patients, from those naïve to any immunomodulatory treatment to those refractory to multiple biologic therapies.

It will be associated with a multi-omics biobank with the aim of identifying new cellular and molecular signatures of success of the therapeutic strategy at one year.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age;
* Patients with an established diagnosis of IBD: CD, UC, unclassified IBD or refractory chronic pouchitis;
* Patients with active disease requiring surgery or endoscopy, whether performed at diagnosis or prior to initiation of new therapy;
* Patients who have given written consent to participate in the study and to keep biological samples for research purposes

Exclusion Criteria:

* Patients refusing to participate in the cohort;
* Patients with chronic inflammatory bowel disease quiescent at inclusion;
* Patients with a contraindication to general anaesthesia;
* Vulnerable patients (under court protection, curators, guardians);

Primary outcomes:
measure: Proportion of patients who succeed in their therapeutic strategy
timeFrame: One year after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
city: Nantes
country: France
facility: Clinique Jules Verne
city: Nantes
country: France
facility: Hopital Privé du Confluent
Study officials:
References:
Clinical trial NCT05861193: Treatment of NCCL Asociated With Gingival Recession With B.O.P.T. Technique
Official title: Treatment of NCCL Asociated With Gingival Recession With B.O.P.T. Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abfraction
Keywords: NCCL
B.O.P.T.
Gingival recession
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to evaluate the gingival margin changes resulting from the treatment with biologically oriented preparation technique (B.O.P.T.) of non-carious cervical lesions (NCCL). In particular, the quantification of the cervical margin is carried out by an intraoral scanning device, both in length and width.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age, all sex;
* Presence of a non-carious lesion with loss of dental hard tissue, located in the cervical third of the tooth, and associated with R1 Cairo dental recession; as well, the tooth must be in a healthy condition.

Exclusion Criteria:

* In the tooth to be treated: presence of tartar, periodontal pocket, gingival hypertrophy and/or dental mobility grades II and III; as well as presence of necrosis, fractures and prosthetic restorations;
* Presence of diabetes, coagulopathies, hemostatic and hormonal alterations, smoking habit of more than 10 cigarettes/day;
* Patients being treated with drugs whose side effects may cause gingival hypertrophy (eg hydantoins);
* Presence of any physical and/or mental condition that prevents voluntary giving informed consent to participate in the study.

Primary outcomes:
measure: On the tooth to be treated: Measurement of gingival recession associated to abfraction (before/after treatment).
timeFrame: The initial scan is performed prior to treatment, lasting approximately 5 minutes (maximum). The final scan is performed three month after treatment, once the gingival tissues have healed.
measure: On the tooth to be treated: Measurement of the volume of gingiva at the level of the gingival margin (before/after treatment).
timeFrame: The initial scan is performed prior to treatment, lasting approximately 5 minutes (maximum). The final scan is performed three month after treatment, once the gingival tissues have healed.
Secondary outcomes:
measure: Periodontal probing of all teeth
timeFrame: Before and after 3 months post-treatment
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universidad de Valencia
Study officials:
affiliation: University of Valencia
name: Ruben Agustin Panadero, PDI-Titular
role: PRINCIPAL_INVESTIGATOR
References: