louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03046966: Manikin To Patient Intubation: Does It Translate?
Official title: Manikin To Patient Intubation: Does It Translate?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates a new approach to the instruction of pediatric residents in the skill of neonatal intubation. Half of the participants will receive focused simulation training and cognitive instruction while the other half will not. The collected data from both groups will be compared.

Detailed description: Current findings suggest that the training of pediatric residents is not sufficient prior to "live" tracheal intubations in the critical care setting. The current one to two days of airway management training as a part of resuscitation training (such as Pediatric Advanced Life Support (PALS) or Neonatal Resuscitation Program (NRP) is not sufficient to provide safe intubation skills.

This study will develop and implement tracheal intubation training using concepts of deliberate practice modeled after Ericsson. The concepts include focused training on a specific task, immediate feedback, time for problem solving and evaluation, and opportunities for repeated performance using a manikin. This proposal is an attempt to develop such a training model. Video recordings of live intubations will be reviewed and evaluated. The data between the two groups will be compared to see if there is improved intubation skills of live patients.

Eligibility criteria: Inclusion Criteria:

* Male and female residents from 18-89 years of age who have been assigned to the Neonatal Intensive Care Unit (NICU) for a monthly rotation are eligible to participate. At the beginning of all NICU rotations, all pediatric residents will be invited to participate in this research.

Exclusion Criteria:

* Any pediatric resident who does not wish to participate

Primary outcomes:
measure: Successful Intubation Encounters on Live Neonates
timeFrame: 1 month- neonatal intensive care unit (NICU) rotation
Secondary outcomes:
measure: Successful Intubations on the First Attempt
timeFrame: 1 month- NICU rotation
measure: Total Number of Intubation Encounters Performed by Each Resident During Their NICU Rotation
timeFrame: 1 month- NICU rotation
measure: Change in Time to Intubate the Mannequin
timeFrame: 1 month- NICU rotation
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Richard W Hall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03908866: Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit
Official title: Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit. Comparative of Cost-Effectiveness and Safety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thromboses, Venous
Infection
Economic Problems
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aim to compare the cost-effectiveness and safety between centrally and peripherally inserted central venous catheters in neurosurgical intensive care unit patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the neurosurgical intensive care unit , who require central access for the treatment of their illness.

Exclusion Criteria:

* Insertion of the central catheter in emergency situations;
* Anatomical abnormalities of upper extremity affecting PICC placement;
* Current or recent (within 1 month) diagnosis of bacteremia
* Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis;
* Presence of skin changes in the area of the puncture, such as thrombophlebitis, dermatitis, cellulitis, burn among others;

Primary outcomes:
measure: thrombotic complications
timeFrame: up to 30 days or be discharged from hospital
measure: mechanical complications
timeFrame: up to 30 days or be discharged from hospital
measure: infectious complications
timeFrame: up to 30 days or be discharged from hospital
Secondary outcomes:
measure: catheter replacement
timeFrame: up to 30 days or be discharged from hospital
measure: cost effectiveness
timeFrame: up to 30 days or be discharged from hospital
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Hao Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00185666: Cyberknife Precision Radiation Delivery System for Tumors of the Spine
Official title: Cyberknife Precision Radiation Delivery System for Tumors of the Spine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Cancer
Brain (Nervous System) Cancers
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the usefulness of Cyberknife precision radiation in eliminating or preventing the further growth of spinal tumors and lesions.


Eligibility criteria: Inclusion Criteria:- Intra-axial, extra-axial, or vertebral spinal lesion

* Age \> 5
* Histologic confirmation of malignant primary lesion or radiographic diagnosis of benign or vascular spinal lesion
* No rapidly deteriorating symptoms of spinal cord compression
* No instability of the spine
* Life expectancy \> 6 months Exclusion Criteria:- Patients without tumors of the spine
* Patients younger than 5 years old

Primary outcomes:
measure: Usefulness of Cyberknife precision radiation in eliminating or preventing the further growth of spinal tumors and lesions
timeFrame: completed
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Iris Catrice Gibbs
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibbs IC, Chang SD. Radiosurgery and radiotherapy for sacral tumors. Neurosurg Focus. 2003 Aug 15;15(2):E8. doi: 10.3171/foc.2003.15.2.8.
citation: Gibbs IC, Kamnerdsupaphon P, Ryu MR, Dodd R, Kiernan M, Chang SD, Adler JR Jr. Image-guided robotic radiosurgery for spinal metastases. Radiother Oncol. 2007 Feb;82(2):185-90. doi: 10.1016/j.radonc.2006.11.023. Epub 2007 Jan 24.
citation: Dodd RL, Ryu MR, Kamnerdsupaphon P, Gibbs IC, Chang SD Jr, Adler JR Jr. CyberKnife radiosurgery for benign intradural extramedullary spinal tumors. Neurosurgery. 2006 Apr;58(4):674-85; discussion 674-85. doi: 10.1227/01.NEU.0000204128.84742.8F.
citation: Sinclair J, Chang SD, Gibbs IC, Adler JR Jr. Multisession CyberKnife radiosurgery for intramedullary spinal cord arteriovenous malformations. Neurosurgery. 2006 Jun;58(6):1081-9; discussion 1081-9. doi: 10.1227/01.NEU.0000215891.25153.BA.
Clinical trial NCT04461366: Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars
Official title: Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Atrophica
Keywords: Acne scars
Monopolar radiofrequency
Pulsed dye laser
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: The acne scar is a common disorder characterized by skin eruption or abnormalities on face, chest, and/or back in the adolescence which affect the cosmetic appearance.

Purpose: The main aim of this study was to investigate whether monopolar radiofrequency (MRF) or pulsed dye laser (PDL) is more effective in the cases suffering from acne scars in the form of reducing acne scars and improving the cosmetic appearance.

Detailed description: Thirty patients suffering from moderate or severe acne scars were randomly assigned into two equal groups. Group A (MRF group): received 2 sessions per week with MRF for 8 weeks. Group B (PDL group): received 1 session per week with PDL for 8 weeks. The severity of acne scars was assessed before and after treatment by using the clinical evaluation scale for acne scarring (ECCA) scale and the self-assessment of clinical acne-related scars (SCARS) scale. Quality of life and the emotional impact of acne scars were evaluated by the facial acne scar quality of life (FASQoL) scale.

Eligibility criteria: Inclusion Criteria:

* Patients with mild to severe acne scar
* Patients with acne scar in the face

Exclusion Criteria:

* Smokers and alcohol drinker
* Patients who had a history of diabetes, circulatory or sensory disorders
* Patients who had a history of frequent sunburns
* Patients with nodulocystic acne

Primary outcomes:
measure: acne scars severity by investigator
timeFrame: after 8 weeks of intervention
measure: acne scars severity by the participant
timeFrame: after 8 weeks of intervention
Secondary outcomes:
measure: emotional, social functioning and work/school effect of scars
timeFrame: after 8 weeks of intervention
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Radwa T Elshorbagy
Study officials:
affiliation: lecturer at faculty of physical therapy
name: Nesma M Allam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03442465: Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas
Official title: Assessment of Healing and Function After Surgical Reconstruction for Neoplasms Involving Bone
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Sarcoma
Osteosarcoma
Chondrosarcoma
Ewing's Sarcoma
Osseous Sarcoma
Bone Neoplasm
Keywords: 18-014
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants who undergo osseous reconstructive surgery at Memorial Sloan Kettering Cancer Center

Brief summary: The purpose of this study is to look at the amount of function that returns in participants that have reconstruction with bone graft or artificial device and in participants who have tumor surgery plus regenerative osseous surgery.

The study will look at the level of function for a period of 3 years after the surgery. Another purpose of this study is to look at how well the bone heals in participants undergoing regenerative surgery


Eligibility criteria: Inclusion Criteria:

* All patients undergoing reconstructive surgery for neoplasms involving bone on the orthopaedic surgery service at MSK
* Current or prior history of primary neoplasms involving osseous structures, including all subtypes
* Confirmation of diagnosis that has been performed by the MSK's Department of Pathology via direct review of tissue/slides
* Patients must read and understand English
* Age \>/=4
* Patients must read and understand English

Exclusion Criteria:

* Patients that weight \<17 kilograms

Primary outcomes:
measure: Early recovery level
timeFrame: 1 year from surgery
measure: Mid-recovery level
timeFrame: 3 years from surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent and Followup)
state: New Jersey
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent and Followup)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Daniel Prince, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05709665: Incidence of the Out- and in Hospital Cardiac Arrest at a Tertiary Hospital in Germany
Official title: Incidence and Special Informations From Patients of the Out- and in Hospital Cardiac Arrest at a Tertiary Hospital in Germany
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Resuscitation
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cardiac arrest patients at a tertiary hospital

Brief summary: Incidence of the background information, incidence and special characteristics of out- and in-hospital cardiac arrest at a tertiary hospital in Germany.

Detailed description: To evaluate background information for planning a eCPR Program at a tertiary hospital, the investigators planned a prospective study of every out- and in-hospital cardiac arrest.

Eligibility criteria: Inclusion Criteria:

* All patients with a cardiac arrest

Exclusion Criteria:

* not complete fill out evaluation forms

Primary outcomes:
measure: Time to eCPR Decision during high quality CPR
timeFrame: < 10 Minutes
Secondary outcomes:
measure: Patient characteristics
timeFrame: < 10 Minutes
measure: Rescue/Emergency team time intervals
timeFrame: < 60 Minutes
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Center Mainz
name: Marc Kriege, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02239965: Qualitative Analysis of Barriers to Consistent Use of Neuromuscular Monitoring in General Anaesthesia
Official title: Qualitative Analysis of Barriers to Consistent Use of Neuromuscular Monitoring in General Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Keywords: Neuromuscular blockade
Neuromuscular monitoring
Focus group interview
Clinical observation
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 40
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: Anaesthesiologists and nurse anaesthetists at Danish anaesthesia departments.

Brief summary: Monitoring the degree of neuromuscular blockade in general anaesthesia reduces complications and patient discomfort. However, monitoring is not applied consistently by Danish anaesthesia personnel. Surveys show that part of the explanation is that the anaesthetists often experience problems with the equipment used for monitoring, though the problems have not been described in detail.

We hypothesise that the lack of consistent monitoring in general anaesthesia is caused by insecurity in the anaesthesia personnel's set-up and use of the equipment, as well as in interpreting the measurement results.


Eligibility criteria: Inclusion Criteria:

* has been working in the field of anaesthesiology for at least 1 year.

Exclusion Criteria:

* none

Primary outcomes:
measure: Description of the barriers to consistent neuromuscular monitoring, based on a qualitative analysis of focus group interviews with anaesthesiologists and nurse anaesthetists
timeFrame: Focus group interviews conducted Sep. - Oct. 2014 (2 months)
Secondary outcomes:
measure: Description of the problems experienced with neuromuscular monitoring in daily clinical practice
timeFrame: Clinical observations conducted in Sep. - Oct. 2014 (2 months)
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
References:
Clinical trial NCT01958866: Study of Efficacy and Safety of Tinospora Crispa-extract Product Compared With the Acetaminophen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Patients With Body Temperature Between 37.8-38.5
No Sign of Infection
No Liver and Kidney Problem
Keywords: Fever
Body temperature
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Tinospora Crispa-extract Product can reduce pyretic similar to acetaminophen.

This study aims to investigate the efficacy and safety of Tinospora Crispa-extract product compared with the acetaminophen. Total of 96 patients with body temperature between 37.8-38.5 without any signs of infections will be enrolled in this study. Patients will be randomly divided into 3 groups: First group will receive acetaminophen 1000 mg every 6 hr, Second group will receive Tinospora Crispa-extract Product 2000 mg twice daily and the third group will receive placebo twice daily.

Detailed description: Patients in each group will be monitored for body temperature at baseline (at the time of enrollment) and at 1, 2, 4, 6, 8, 24 h after receiving the tested material.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Body temperature between 37.8-38.5
* Body weight not less than 40 kg but not over 100 kg
* Liver enzymes do not exceed 2 times of normal value
* Can comply with study protocol

Exclusion Criteria:

* Have allergic history of any tested compounds
* Fever from other causes, not by URI
* Take any herbal medicines during 2 weeks before enrollment
* Physicians decide to withdraw the subjects with any reasons

Primary outcomes:
measure: Body Temperature
timeFrame: Change from baseline in temperature at 1, 2, 3, 4, 6, 8, 12 and 24 hours
Secondary outcomes:
measure: Number of adverse events: diarrhea, elevated liver enzyme and elevated creatinine
timeFrame: Participants will be followed for the duration of hospital stay (24 hours)
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Pornanong Aramwit
Study officials:
References:
Clinical trial NCT00346866: Anecortave Acetate Versus Placebo in AMD Patients Following PDT
Official title: Anecortave Acetate Versus Placebo in AMD Patients Following PDT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: AMD
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-06-30
Enrollment: 136
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the efficacy of anecortave acetate for depot suspension (30 mg and 15 mg) plus PDT versus PDT alone with respect to maintenance of visual acuity in patients with wet AMD.


Eligibility criteria: Inclusion Criteria:

* AMD disease

Exclusion Criteria:

* Age

Primary outcomes:
measure: Mean change from the baseline in logMAR visual acuity score at Month 6
Secondary outcomes:
measure: % patients who maintained vision, number of months of angiographic evidence of needing PDT re-treatment, and mean lesion sizes for the total choroidal neovascularization (CNV) and the classic component to the total CNV.
Other outcomes:
Locations:
city: Beachwood
country: United States
facility: Facility
state: Ohio
Study officials:
affiliation: Alcon Research
name: Patricia Zilliox
role: STUDY_DIRECTOR
References:
Clinical trial NCT02751866: Early Intervention in Cognitive Aging
Official title: Early Intervention in Cognitive Aging
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight, Obesity and Other Hyperalimentation (E65-E68)
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention with carbohydrate restriction designed to produce adaptation to ketone metabolism OR intervention with berry fruit powder supplementation.
Primary purpose: PREVENTION

Brief summary: Nutritional intervention in overweight middle aged individuals with subjective memory complaints.

Detailed description: Late-onset AD develops over many years during a preclinical period in which neuropathological changes accumulate before dementia is evident. Deposition of amyloid-beta (Aβ) in the brain is the earliest recognized biomarker of AD pathology, and, demographically, Aβ accumulation begins to accelerate at age 50, a period when the incidence of metabolic disturbance increases as well. Hyperinsulinemia associated with insulin receptor resistance has been associated with AD pathololgy, and metabolic disturbance in mid-life increases risk for subsequent dementia. There are indications that subjective memory complaints can be an early indicator of developing neuropathology and may be the first manifestation of future dementia. This research involves intervention studies in different samples of individuals from this population to investigate the extent to which berry fruit supplementation and ketone metabolism might improve cognitive performance in association with enhancement of metabolic function and related factors. The ultimate goal of this research is to develop interventional approaches that might be applied with at-risk individuals in the preclinical period of dementia to forestall or prevent progression of neurocognitive decline.

Eligibility criteria: Inclusion Criteria:

* overweight; subjective memory complaints

Exclusion Criteria:

* diabetes; liver or kidney disease; age-related memory disorder; neurologic or psychiatric condition; substance abuse

Primary outcomes:
measure: Insulin resistance
timeFrame: Eight or 12 weeks after enrollment
measure: Cognitive function
timeFrame: Eight or 12 weeks after enrollment
Secondary outcomes:
measure: Long term glucose concentration
timeFrame: Eight or 12 weeks after enrollment
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Dept of Psychiatry & Behavioral Neuroscience, UC Academic Health Center
state: Ohio
Study officials:
affiliation: University of Cincinnati Academic Health Center
name: Robert Krikorian, PhD
role: PRINCIPAL_INVESTIGATOR
References: