louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01095861: Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube
Official title: Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Keywords: endotracheal tube
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2010-03-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tubes (ETT).

Detailed description: The post-operative complication of a sore throat after endotracheal intubation is unfortunately common, with estimates ranging from 15-50%. Most estimates are in the order of 35-45%.(McHardy 1999, Higgins 2002) There is evidence that many patients do not report sore throat and/or vocal changes unless directly asked because surgical pain is more prominent and many patients may be unaware that intubation completed as part of the general anesthetic. (Harding 1987)

The Parker FlexTip® endotracheal tube (ETT) is formulated with a softer plastic at the distal tip as well as a laterally curved profile to reduce trauma during ETT advancement. (Makino 2003) This ETT has been shown to be faster during fibreoptic intubation, but complication of sore throat was not examined. (Kristensen 2003)

Our previous study (Jones 2007) demonstrated that modification of anesthetic techniques could reduce the incidence of post-operative sore throat in patients undergoing naso-tracheal intubation. We will now study the Parker Flex-Tip ETT to see if its use can also reduce the incidence of sore throat in patients undergoing oro-tracheal intubation.

Eligibility criteria: Inclusion Criteria:

* Any adult patient scheduled for elective surgery.
* ETT is indicated for the procedure in the opinion of the attending anesthesiologist.

Exclusion Criteria:

* Any patients with known or probable difficult airways.
* Any patient requiring rapid sequence induction.

Primary outcomes:
measure: Sore throat
timeFrame: 48-72 hours
Secondary outcomes:
measure: Vocal changes
timeFrame: 48-72 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: University of Western Ontario
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Timothy P Turkstra, MD, M. Eng
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University, Canada
name: Philip M Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turkstra TP, Smitheram AK, Alabdulhadi O, Youssef H, Jones PM. The Flex-Tip tracheal tube does not reduce the incidence of postoperative sore throat: a randomized controlled trial. Can J Anaesth. 2011 Dec;58(12):1090-6. doi: 10.1007/s12630-011-9592-5. Epub 2011 Nov 5.
Clinical trial NCT04950361: Follow-up of Patients With Talocalcaneal Coalitions
Official title: Follow-up of Patients With Talocalcaneal Coalitions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Talocalcaneal Coalition
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that were diagnosed with talocalcaneal coalition using a CT scan, between January 2009 and February 2021.

Brief summary: The objective of this study was to develop a new classification system based on the articular facets involved to cover all coalitions and guide operative planning.

Detailed description: Patients were diagnosed with talocalcaneal coalition using a CT scan, between January 2009 and February 2021. We classified the coalition into four main types according to the shape and nature of the coalition: I, inferiorly overgrown talus or superiorly overgrown calcaneus; II, both talus and calcaneus overgrew; III, coalition with an accessory ossicle; (I-III types are non-osseous coalition) IV, complete osseous coalition. Then each type was further divided into three subtypes according to the articular facets involved. A, the coalition involving the anterior facets; M, the coalition involving the middle facets, and P, the coalition involving the posterior facets.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as talocalcaneal coalition by CT or MRI at the outpatient
* Underwent arthroscopic talocalcaneal coalition resection due to failure of conservative treatment

Exclusion Criteria:

* The affected side underwent other foot and ankle operations
* Combined with other ankle diseases
* Refused to participate in the study

Primary outcomes:
measure: CT
timeFrame: pre-surgery
Secondary outcomes:
measure: MRI
timeFrame: pre-surgery
measure: AFOAS
timeFrame: pre-surgery, one year after sugery
measure: Tegner
timeFrame: pre-surgery, one year after sugery
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Qinwei Guo, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05677061: Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
Official title: Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intertrochanteric Fractures
Keywords: Stable Fractures (Evans I, II, IV)
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Hospitalsenheden Vest
name: Hvidovre University Hospital
First posted: 2023-01-10
Enrollment: 37
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient and Assessor blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Evaluated whether HA coated dynamic hip screws can improve fixation of the screw in trochanteric femoral fractures

Detailed description: Randomised study to determine the effect of HA coating on the stability of dynamic Hip screws used to stabilize femoral neck fractures. Stability of the screw will be determined by RSA measurements. Additionally the fracture stability will be evaluated by RSA measurements.

Eligibility criteria: Inclusion Criteria:

* Patients with stable intertrochanteric femoral fractures (Evans I, II, IV)
* able to speak Danish
* able to complete the postoperative controls
* written consent

Exclusion Criteria:

* unable to follow standard hip fracture regime
* were breastfeeding
* pregnant
* terminal disease
* in need of open fracture reduction
* in need of DHS plate with an angle different from 135 degrees
* insertion of fewer than 3 tantalum beads in the femoral head (for RSA)
* TAD \>20mm in two dimensions in the first postoperative x-ray
* fracture displacement \>20mm in two dimensions in the first postoperative x-ray

Primary outcomes:
measure: Lag Screw migration measured as y-translation (mm)
timeFrame: 6 months PO
Secondary outcomes:
measure: Lag screw migration measured as translations in mm
timeFrame: 6 months PO
measure: Lag screw migration measured as rotations in degrees
timeFrame: 6 months PO
measure: Radiological measurements
timeFrame: 6 months
measure: Clinical outcomes - HHS
timeFrame: 6 months PO
measure: Clinical outcomes - NMS
timeFrame: Preoperative
measure: Clinical outcomes - Leg Lengths difference
timeFrame: 6 months
measure: Clinical outcomes - TUG test
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02706561: Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
Official title: Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Erectile Dysfunction
Keywords: 15-317
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Center for Marital and Sexual Health of South Florida
First posted: 2016-03-11
Enrollment: 224
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test two different ways to help men with sexual rehabilitation.


Eligibility criteria: Inclusion Criteria:

* As per medical record, early stage prostate cancer (Pathologic Stage 1/2 with Gleason score \</=8; or Pathologic Stage 3 with Gleason score =/\< 7)
* As per medical record, radical prostatectomy (RP) conducted either at MSKCC or at another institution
* As per medical record, ≤ 9 months post-RP
* As per medical record, moderate erectile functioning pre-surgery (i.e., 15 or greater on the IIEF Erectile Function Domain (EFD) score, or graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale, or have a score of 6 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment or have a total score of 15 or greater on items 2-7 on the Prostrate Quality of Life Survey: Sexual Domain)
* As per self report or as per medical record starting penile injections as part of the erectile rehabilitation program at MSKCC
* In the judgment of the consenting professional able to communicate, comprehend, and complete questionnaires in English

Exclusion Criteria:

* Both cavernous nerves fully resected as per surgery report (nerve sparing score of 8 in MSKCC surgeon note), or documented in the progress note that the nerves were fully resected.
* Currently on or has a history of being an Androgen Deprivation Therapy (ADT)
* Has any indication of Prostate-Specific Antigen (PSA)
* As per self report, specific injection phobia
* In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.
* As per self report or as documented in the medical record, current untreated (e.g. no medication no therapy) major psychiatric disorder (schizophrenia, major depression). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.

Primary outcomes:
measure: percentages of patients having an Erectile Function Domain (EFD) total score >= 24
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Chris Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06780761: Infant Simulator Training to Measure Pediatric Vital Signs
Official title: Infant Simulator Training to Measure Pediatric Vital Signs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vital Signs
Simulation Training
Keywords: vital sign
pediatric
nursing
simulation
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The author further demonstrated taking body temperature, heart rate and its characteristics, respiratory rate and saturation, blood pressure and pain assessment in line with previously created cases on the NOELLE® Maternal Birthing Simulator with Advanced Resuscitation Neonatal M-W45111 to the students deployed in the intervention group
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Providing training to nursing students in the field of pediatric care requires having the competencies to care for the pediatric population. However, as the margin of error in pediatric care is quite narrow, nursing students need to undertake a comprehensive laboratory practice before implementing their care skills unsupervised in the pediatric ward. Nursing students can develop their professional skills by gaining the necessary confidence and skills with simulation methods.

Detailed description: Simulation makes possible for students to feel a pulse, observe chest movements, hear respiration sounds, measure blood pressure, and evaluate results, thus allowing students to practice with concrete examples of various conditions. Hence simulation-based training, one of the important learning techniques, is assumed to help nursing students overcome the difficulties they will experience in measuring the children's vital signs

Eligibility criteria: Inclusion Criteria:

* Having taken the Pediatric Nursing course
* Voluntarily participating in the study

Criteria for exclusion from the study were as follows:

* Failure to complete the research process
* Filling out the necessary forms incompletely

Primary outcomes:
measure: Vital Signs Scale (V-Scale)
timeFrame: It was assessed just before training as baseline. When all training was completed, ıt was assessed after 1 week again.
Secondary outcomes:
measure: Student Satisfaction and Self-Confidence in Learning Scale
timeFrame: When simulation based training was completed, ıt was assessed after 1 week.
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Black Sea Zone
Study officials:
affiliation: Ondokuz Mayıs University
name: Hatice Uzşen, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01578161: The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia
Official title: The Effect of Dexmedetomidine on Emergence Agitation in Children Undergoing a Surgery Under Desflurane Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Psychomotor Agitation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 116
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: After genernal anesthesia using sevoflurane or desflurane, the investigators can observe many cases of agiation (over 80%) and despite of no report of long-term complication, agitation is a big issue in PACU for doctors and nurses. The investigators use dexmedetomidine for prevention of agiation of preschool aged children. The investigators expect single injection of dexmedetomidine lead to decrease postoperative agitation and pain without any complication like oculocardiac reflex requiring atopine for treatment.

Detailed description: There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.

Eligibility criteria: Inclusion Criteria:

* Physical status classification of American Society of Anesthesiologist 1-2,
* Healthy, normal
* 2-6 years old
* Elective operation

Exclusion Criteria:

* Lack of consent
* Known adverse effects to dexmedetomidine, mental retardation
* Developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc)
* No cardiac disease

Primary outcomes:
measure: Agitation score
timeFrame: 30 mins after operation
Secondary outcomes:
measure: Oculomotor reflex
timeFrame: Intraoperative
Other outcomes:
Locations:
city: SungNam-si
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL
state: Kyonggi do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: AhYoung Oh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04871061: Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients
Official title: Evaluation of Pericapsular Nerve Group Block on Positioning Pain for Spinal Anesthesia in Hip Fracture Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: hip fracture, postoperative analgesia, positioning pain
Lead sponsor: Cigli Regional Training Hospital
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
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 evaluate of analgesic effects of pericapsullar nerve group block which is performed preoperatively to assist positioning patients for performance of spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* hip fracture
* aged between 35 and 90 years old

Exclusion Criteria:

* contraindications for spinal anesthesia and PENG block
* impaired cognition or dementia
* multiple fractures
* any previous analgesic administration during the last 12 hours

Primary outcomes:
measure: Pain scores on the Numeric Rating Scale (NRS)
timeFrame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Secondary outcomes:
measure: Duration of spinal anesthesia performance
timeFrame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
measure: Quality of patient's position
timeFrame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
measure: Analgesic consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Hakan Aygün
Study officials:
affiliation: Cigli RTH
name: Hakan Aygun, MD
role: STUDY_DIRECTOR
References:
citation: Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.
Clinical trial NCT04573361: Access to Chiropractic Care During the COVID-19 Healthcare Emergency in Spain
Official title: Access to Chiropractic Care During the State of Emergency Generated by the COVID-19 Pandemic in Spain: a Pragmatic Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Disability Physical
Psychological Distress
Lead sponsor: Real Centro Universitario Maria Cristina
Sponsor class: OTHER
Collaborators: name: Université du Québec à Trois-Rivières
name: University of Birmingham
First posted: 2020-10-05
Enrollment: 723
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three arms depending on the access to chiropractic care (no access, one visit or more than one) during the 14-days period of the trial. Measures were taken at the beginning and at the end of the 14-day period.
Primary purpose: TREATMENT

Brief summary: This is a pragmatic controlled clinical trial taking place in the first phase of COVID-19 lockdown re-opening in Spain. Patients of 52 chiropractic clinics were invited to participate in a pseudo-random order (one out of every three contacted patients) as they were contacted to either schedule an appointment with their current chiropractor or not, depending on the clinic's and the patient's availability. Patients would receive chiropractic in-person care (one or more than one visits) or no care at all, for a two-week period. According to the care received, they were assigned to one of three groups (receiving no care, receiving care once, and more than once). Participants filled an online questionnaire with self-reported outcome-measures at the beginning of the two week period. A follow-up questionnaire was completed 14 days after.


Eligibility criteria: Inclusion Criteria:

* chiropractic patients active when lockdown was declared, over the age of 14

Exclusion Criteria:

* new patients in the clinic, patients with no current pain at the time of the trial

Primary outcomes:
measure: Pain intensity
timeFrame: 14 days
measure: Pain frequency
timeFrame: 14 days
measure: Pain evolution
timeFrame: 14 days
measure: Pain interference
timeFrame: 14 days
Secondary outcomes:
measure: Pain Catastrophizing Scale
timeFrame: 14 days
measure: Tampa Scale Kinesiophobia
timeFrame: 14 days
measure: General Anxiety Disorder scale
timeFrame: 14 days
measure: Intolerance of Uncertainty Scale
timeFrame: 14 days
measure: General Self-Efficacy scale
timeFrame: 14 days
measure: Fear of Illness and Virus Evaluation
timeFrame: 14 days
Other outcomes:
Locations:
city: San Lorenzo De El Escorial
country: Spain
facility: Real Centro Universitario María Cristina
state: Madrid
Study officials:
affiliation: Madrid College of Chiropractic - Real Centro Universitario Maria Cristina
name: Arantxa Ortega de Mues, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02926261: Methods for Nutritional Assessment in Cirrhosis
Official title: Evaluation of Three Methods for Nutritional Assessment in Patients With Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Cachexia
Malnutrition
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort of patients with cirrhosis

Brief summary: Nutritional status in patients with cirrhosis has been shown to have a direct influence on the prognosis of these patients, it is related to higher mortality and it has been linked to the developement and perpetuation of certain complications such as hepatic encephalopathy, ascites and spontaneous bacterial peritonitis.

Despite the importance of nutritional status in this patients, most of the methods for its assessment are still not completely reliable or not easily accessible; therefore, evaluating nutritional status in the daily clinical practice is still a complex task.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cirrhosis
* No restriction of etiology
* 18-75 years
* Child-Pugh stage A/B/C
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Extremity amputation
* Malignancy different from hepatocellular carcinoma

Primary outcomes:
measure: Nutritional status
timeFrame: Evaluation at time of recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
state: DF
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Aldo Torre, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: