louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04361929: Pediatric Difficult Airway Prediction Using Ultrasonography
Official title: Pediatric Difficult Airway Prediction Using Ultrasonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Intubation
Difficult Mask Ventilation
Keywords: Difficult airway
pediatric
Airway ultrasound
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 584
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 584 consecutive pediatric patients, aged one month-10 years scheduled for elective surgery under general anesthesia will be included in the study.

Brief summary: Recognition of difficult airway is purported to be the most important factor in successful management of difficult airway. The incidence of difficult airway in pediatrics is much less than in adults; however, airway related complications can lead to hypoxic brain damage or even death especially in younger age groups as neonates and infants.The aim of this work is to evaluate the feasibility and accuracy of ultrasound measurements (hyomental distances, tongue measurements, and anterior neck soft tissue thickness at the level of hyoid bone, thyrohyoid membrane, and thyroid cartilage) in predicting difficult laryngoscopy and difficult mask ventilation in pediatric patients undergoing elective surgery under general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Gender both males and females
* ASA Class I and II
* Age 1month to 10 years
* Children undergoing elective surgery under general anaesthesia

Exclusion Criteria:

* congenital upper airway malformation,
* head and neck swellings,
* scars,
* radiation to the neck,
* tracheotomy,
* Neurosurgical or cardiac procedures
* ENT surgeries

Primary outcomes:
measure: The sensitivity of DS-HB to predict difficult laryngoscopy
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy
Study officials:
References:
Clinical trial NCT01722929: Study of Skin and Muscle Parameters Using a Skin Sensor
Official title: A Pilot Study of Skin and Muscle Parameters Using a Multifunctional Skin Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Wounds
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants had the skin sensor measure temperature both near a surgery site and also near a non-surgery site. There is one intervention (skin sensor) and the participants were assigned to both arms "surgery side" and "non-surgery side" in parallel.
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to assess the role of skin sensors in obtaining reliable and accurate serial measurements of skin parameters in the context of cutaneous skin wound healing.


Eligibility criteria: Inclusion Criteria:

* Males and Females age 18 and over
* Recent (post-operative day 0-90) skin surgery of the trunk,extremities, head or neck for minor skin problems resulting in sutured wounds or open granulating wounds.
* Otherwise good general health as assessed by the investigator
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or Lactation
* Subjects who are unable to understand the protocol or to give informed consent

Primary outcomes:
measure: Measure Temperature at 3 Time Points
timeFrame: Baseline, 48 hours from baseline, and 2 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00840229: Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder
Official title: Rotator Interval and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: adhesive capsulitis
corticosteroids
injection
pain
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 122
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare ultrasound guided capsular corticosteroid injection into the rotator interval/anterior capsule and the GH joint with ultrasound guided corticosteroid injection into the GH joint only. Both methods will be compared with placebo injections.

Primary outcome measure: pain reduction at week 6 Secondary outcome measures: improvement of function (SPADI, Life quality, ROM).

0-hypothesis: no difference between the methods.

The investigators want to find out if the clinical effect of the combined capsular and intra-articular injections are better than placebo and better that intra-articular injections

Detailed description: 3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks.

Eligibility criteria: Inclusion Criteria:

* Pain and stiffness in one shoulder 1 - 6 months
* Restriction of passive ROM; \>= 30 degrees in two or more planes compared to other shoulder

Exclusion Criteria:

* Systemic inflammatory disease
* Corticosteroid treatment last 3 months
* Poorly controlled Diabetes mellitus
* Pregnancy
* Contraindications/allergy to corticosteroids and/or Lidocaine
* Severe infections
* Osteoarthritis of the shoulder
* Fractures of the shoulder
* Rotator cuff pathology causing pain or disability
* Fibromyalgia
* Not able to understand Norwegian

Primary outcomes:
measure: Pain reduction
timeFrame: 2-3 years
Secondary outcomes:
measure: Function (ROM, SPADI), Life quality
timeFrame: 2-3 years
Other outcomes:
Locations:
city: Stavern
country: Norway
facility: Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation
Study officials:
affiliation: The Hospital of Vestfold
name: Tore A Prestgaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prestgaard T, Wormgoor MEA, Haugen S, Harstad H, Mowinckel P, Brox JI. Ultrasound-guided intra-articular and rotator interval corticosteroid injections in adhesive capsulitis of the shoulder: a double-blind, sham-controlled randomized study. Pain. 2015 Sep;156(9):1683-1691. doi: 10.1097/j.pain.0000000000000209.
Clinical trial NCT03212729: Antimicrobial Photodynamic Therapy Associated With the Conventional Endodontic Treatment: A Clinical and Microbiological Study
Official title: Antimicrobial Photodynamic Therapy Associated With the Conventional Endodontic Treatment: A Clinical and Molecular Microbiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Photochemotherapy Reaction
Dental Pulp Necrosis
Polymerase Chain Reaction
Infection
Enterococcal Infections
Candida
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2017-07-11
Enrollment: 10
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Microorganisms play a critical role in the etiology and pathogenesis of apical periodontitis. Enterococcus faecalis and Candida sp. are frequently associated with persistent infections. The aim of this study was evaluated the antimicrobial photodynamic therapy (aPDT) as an adjunct of the endodontic treatment. Ten uniradicular teeth \[control group (CG)=4 and test group (TG)=6\] with primary endodontic infections were analyzed. Microbiological samples were collected before and after the chemical-mechanical instrumentation (CMI), after the aPDT (for the TG) and after the temporary restorations removal (second session).


Eligibility criteria: Inclusion Criteria:

* Patients with teeth with: single canal with endodontic infection, intact pulp chamber walls, necrotic pulp confirmed by sensitivity pulp tests, and clinical and radiographic evidence of asymptomatic apical periodontitis

Exclusion Criteria:

* Patients with teeth with: gross carious lesions, root or crown fracture, previous endodontic treatment, gingival recession and periodontal pockets deeper than 4 mm.
* Patients pregnant, lactating, with systemic diseases that could compromise the immune system, individuals who received antibiotic therapy within the previous 3 months or in immunosuppressive treatment.

Primary outcomes:
measure: Antimicrobial photodynamic therapy (aPDT) evaluation on microorganisms erradication in canal roots after endodontic tretament and immediately use aPDT
timeFrame: Microorganisms detection were evaluated one month later
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03129529: Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia
Official title: Comparing the Effect of Focused and Radial Extracorporeal Shock Waves on Post-stroke Hypertonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spasticity
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare treatment efficacy of focused and radial extracorporeal shock waves on spasticity in chronic stroke patient

Detailed description: This study is a prospective and double-blinded randomized control trial. Thirty-two stroke patients with spastic equinus were randomly assigned to receive three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals. The intensities that were used during FSWT (0.1 mJ/mm2) and RSWT (2 bar) were comparable. Patients were evaluated at baseline and at 1, 4, 8 weeks after the final shockwave treatment. The primary outcome measure was modified Ashworth scale (MAS) score. Secondary outcome measures were Tardieu scale, ankle passive range of motion, plantar contact area during gait, and gait speed. A linear mixed model with repeated measures was used to compare each outcome measure between the two groups.

Eligibility criteria: Inclusion Criteria:

* aged greater than 18 years old;
* at least 6 months since onset of last stroke;
* triceps surae muscle tone graded at least 1+ on the Modified Ashworth Scale (MAS) score;
* ability to walk alone with/without orthosis.

Exclusion Criteria:

* Exclusion criteria included fixed ankle joint contracture, previous treatment of the affected leg with neurolytic or surgical procedures, concomitant progressive central nervous system diseases, and skin breakdown, vascular disease in the affected leg

Primary outcomes:
measure: Change from baseline of spasticity on 1st, 4th, 8th weeks after treatment.
timeFrame: 1, 4, 8 week
Secondary outcomes:
measure: Change from baseline of range of motion on 1st, 4th, 8th weeks after treatment.
timeFrame: 1, 4, 8 week
measure: Change from baseline of modified Tardieu scale on 1st, 4th, 8th weeks after treatment.
timeFrame: 1, 4, 8 week
measure: Change from baseline of foot contact area on 1st, 4th, 8th weeks after treatment.
timeFrame: 1, 4, 8 week
measure: Change from baseline of gait speed on 8th weeks after treatment.
timeFrame: 8 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
References:
Clinical trial NCT04689529: Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer
Official title: The Percentage of Unnecessary Mastectomy Due to False Size Prediction by Preoperative Imaging Studies in Breast Cancer Patients Who Underwent Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Surgery
IMAGE
Chemotherapy Effect
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 360
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: * The surgical method for breast cancer is determined according to the size and location of the remaining lesions after prior chemotherapy.
* There are many patients who were able to undergo partial resection when confirming the final results of patients who underwent total resection after prior chemotherapy.
* Therefore, we would like to investigate whether it is effective to make decisions based on the results of pre-operative tests after prior chemotherapy.

Detailed description: In a study published by Jennifer F. et al., sensitivity to lesions remaining after prior chemotherapy of breast magnetic resonance imaging was measured as 83%, specificity 47%, PPV 47%, NPV 83%, and accuracy 74%. have.

Most of the preoperative examinations after prior chemotherapy have the most confidence in the results of breast magnetic resonance imaging, but there will be other factors to predict this result as there will be differences in the actual postoperative pathology results. .

After prior chemotherapy, total resection was performed, and cases where partial resection is possible in the postoperative pathologic results are prospectively identified and compared and analyzed.

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients over 20 years of age undergoing surgery at Seoul National University Hospital
* Patients to undergo total mastectomy
* Patients who received neoadjuvant chemotherapy and undergoing total mastectomy were the main subjects, but as a control group, patients who did not receive neoadjuvant chemotherapy but undergoing total mastectomy were included as subjects.

Exclusion Criteria:

* In case of total mastectomy at the request of the patient
* Except for cases where total resection is performed regardless of size because it is a lesion under the areola and is close to the nipple.

Primary outcomes:
measure: Final pathology report
timeFrame: 2 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References:
Clinical trial NCT06184529: Virtual Reality (VR) Regulators
Official title: VR Regulators: Teaching Adults to Manage Children's Big Emotions Through a Brief Virtual Reality Simulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Children's Trust, Miami FL
First posted: 2023-12-28
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test how well a virtual reality simulation helps adults learn new skills for managing children's emotions.


Eligibility criteria: Inclusion Criteria:

* Adult 18 years old or higher AND
* Caregiver of a child ages 3-6 years old OR educator or child allied health or medical professional that regularly works with children ages 3-6 years old

Exclusion Criteria:

* adults who do not speak English or Spanish
* adults with a history of significant motion sickness, active nausea, and vomiting or epilepsy

Primary outcomes:
measure: Adult Emotion Regulation as measured by the Difficulties in Emotion Regulation Scale
timeFrame: Baseline
measure: Changes in adult responses to child emotions as measured by the Adult Responses to Young Children's Strong Emotions Scale
timeFrame: Baseline, up to 10 minutes post-intervention, 1 month post-intervention
Secondary outcomes:
measure: Satisfaction as measured by the Virtual Reality Satisfaction Survey
timeFrame: up to 10 minutes post-intervention
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Jason Jent, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02912429: Onlay vs. Inlay Patellofemoral Arthroplasty
Official title: Onlay- vs. Inlay-Type Patellofemoral Arthroplasty: a Prospective, Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Joint
Osteoarthritis
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is currently no sufficient evidence if there is superiority of one of the two available types (onlay type, inlay type) of patellofemoral arthroplasty. Therefore, it is the aim of this study to compare the two types in a prospective comparative setting. Patients on the waiting list for patellofemoral arthroplasty are randomized to either onlay or inlay type patellofemoral arthroplasty. The KOOS - knee score serves as the primary outcome parameter. Secondary outcome parameters are the Marx Activity Scale, the HSS patella score, the Kujala Score, radiographic loosening, progression of tibiofemoral degeneration, revision surgery and parameters of patellofemoral tracking. Inferential statistics will be performed at 1-year follow up data-sets.


Eligibility criteria: Inclusion Criteria:

* patellofemoral osteoarthritis, waiting list for patellofemoral arthroplasty

Exclusion Criteria:

* systemic inflammatory arthropathy
* tibiofemoral joint degeneration IKDC grade C or worse
* severe degeneration of also the trochlea margins (inlay PFA not adequate)
* patellectomy
* previous implantation of tibiofemoral metal implants
* extension loss \>5 degree
* knee flexion of less than 100°
* planned concomitant tibiofemoral procedures (eg. coronal plane osteotomies, tibiofemoral cartilage procedures, tibiofemoral ligament procedures)

Primary outcomes:
measure: KOOS knee score
timeFrame: 1 year
Secondary outcomes:
measure: Kujala Score
timeFrame: 1 year
measure: Marx Activity Scale
timeFrame: 1 year
measure: HSS patella Score
timeFrame: 1 year
Other outcomes:
measure: radiolucent lines adjacent to the prosthesis
timeFrame: 20 years
measure: revision of prosthesis
timeFrame: 20 years
measure: progression of tibiofemoral osteoarthritis
timeFrame: 20 years
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tyrol
Study officials:
affiliation: Medical University Innsbruck
name: michael liebensteiner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05503329: Prognostic Value of Lactate Levels in Patients With STEMI Undergoing Primary PCI
Official title: Prognostic Value of Systemic Arterial Lactate Levels in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI
Lead sponsor: Ahmed Maher Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2022-08-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: STEMI patients treated with primary PCI

Brief summary: To assess the prognostic value of systemic arterial lactate levels in patients with ST segment elevation myocardial infarction undergoing primary PCI and correlate with the results of primary PCI and 30 days MACE follow up.

Detailed description: * Study Population: STEMI patients treated with primary PCI.
* Study period: over 6 months.
* Sample Size: 300 patients.

All patients received the standard care for acute STEMI patients which is the primary percutaneous intervention in addition to medications.

Hyperlactemia is defined as elevated lactic acid level in the blood. The normal blood lactate level is (0.5-1 mmol/L).

All subjects were subjected to

1. Careful history taking
2. Full cardiac examination
3. Investigations include:

   1. 12 lead surface ECG.
   2. Lactate level and full labs
   3. Pre-discharge echocardiography
   4. Peri-procedural details of primary PCI

the investigators assessed the relation between hyperlactemia and coronary flow, peak cardiac enzymes, hemodynamic parameters and MACE in 30 days follow up

Eligibility criteria: Inclusion Criteria:

* Patient with ST-segment elevation myocardial infarction for the first time.
* Patients undergoing primary PCI.
* Adult patients ≥ 18 years old.

Exclusion criteria:

* Hemodynamically unstable patients.
* Patients with renal impairment (creatinine clearance \< 30 ml/min).
* Patients who developed flow limiting coronary dissection or mechanical complication during the procedure.
* Patients presenting \> 24 hours after symptoms onset.

Primary outcomes:
measure: Major adverse caediac events
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Maher teaching hospiral
state: Elsayda Zainab Square
Study officials:
References:
Clinical trial NCT01600729: Reliability of the Facial Wrinkle Scale in Japanese Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Facial Rhytides
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-05-17
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with facial lines

Brief summary: This study will evaluate the inter-rater and intra-rater reliability of the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) in Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Ability to assess facial lines in a mirror
* Removal of facial jewelry and makeup for study visit

Exclusion Criteria:

* Infection or skin disorder affecting the face
* Planned use of botulinum toxin of any serotype between Screening and Day 1
* Planned facial cosmetic procedure between Screening and Day 1
* Planned excessive/prolonged sun exposure between Screening and Day 1

Primary outcomes:
measure: Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
timeFrame: Day 1
measure: Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: