louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06042829: Impact of Covid-19 Aerosol Box On Intubation Success Rate
Official title: Impact of Covid-19 Aerosol Box On Intubation Success Rate and Intubation Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The safety of novel medical device must be assessed before being implemented into clinical practice. In the case of aerosol box, one of the safety features concerned includes its impact on intubation and how it affect the probability of efficient intubation in order to avoid risk of hypoxia to patient. As the barrier box is newly invented, there have been limited studies published.

This study aims to compare intubation success rate between intubation with and without aerosol box in real patients, which will determine the chances of efficient intubation and reflect the safety features of the aerosol box.

Detailed description: General Objective To determine whether intubation performed using aerosol box will have a lower chance of success as compared to intubation without using the box.

Specific Objectives

1. To determine whether intubation with aerosol box will require more time for successful intubation as compared to intubation without the box.
2. To compare the ease of intubation and determine whether intubation using aerosol box will require additional airway manipulation as compared to intubation without using the box.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old
2. American Society of Anesthesiologist (ASA) I or II patients
3. Tested negative for COVID-19 prior to surgery
4. Patient scheduled for elective surgery under general anaesthesia

Exclusion Criteria:

1. Claustrophobia
2. Difficult airway features
3. Body mass index (BMI) of more than 35 kg/m2
4. Body habitus not physically fit into the aerosol box.

Primary outcomes:
measure: Tracheal intubation time
timeFrame: 1 year
Secondary outcomes:
measure: Ease of tracheal intubation
timeFrame: 1 year
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Universiti Kebangsaan Malaysia
state: Kuala Lumpur
Study officials:
affiliation: National University of Malaysia
name: Nurul Najwa Mohd Noor Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03279029: Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
Official title: Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Aortic Valve Regurgitation Acquired
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To investigate histological structure and molecular changes involved on the onset of AVD after left ventricular assist device (LVAD) implantation and to compare them with those of patients operated on for severe aortic regurgitation.

Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients operated on for severe aortic regurgitation are included as control. Clinical and TTE data are compiled. Samples of aortic valve are collected at the time of the intervention. RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are validated by real time qPCR in both. Blood sampling are performed pre-operatively and at one-month follow up to assess the plasma level of previously identified gene modulators. In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for validation.

Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important information for the understanding of valve remodeling and disease. ECM gene modulators could represent pertinent molecular targets to stop the progression of AVD


Eligibility criteria: Inclusion Criteria:

* Patients with long-term left-ventricular assistance awaiting transplant
* Patients with severe aortic surgical spring deficiency
* Major Patient

Exclusion Criteria:

* Minor Patient
* Pregnant or nursing women
* Major under guardianship
* People in emergencies
* Persons not covered by the social security scheme

Primary outcomes:
measure: blood sample
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: alexis THERON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04983329: Systematic Quality Improvement With Realtime Event Support
Official title: Systematic Quality Improvement With Realtime Event Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Keywords: Telemedicine
Quality-Improvement
surgical antibiotics
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 25506
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this study is to improve perioperative quality metric performance in patients receiving anesthesia care provided by Washington University Department of Anesthesiology. In this protocol, we describe (1) the use of telemedicine-augmented quality improvement interventions to enhance on-time dosage of surgical prophylactic antibiotics, while (2) carrying out large scale monitoring of surgical site infection incidence in the target population. If this quality improvement framework is found to be feasible and successful, we plan subsequently to study its application to additional perioperative quality metrics, including many pertinent to surgical site infection incidence such as perioperative glucose monitoring and management, and intraoperative temperature management.


Eligibility criteria: Inclusion Criteria:

* Patients having procedures at Barnes-Jewish Hospital in suites not part of the TECTONICS trial will be included.

Exclusion Criteria:

* Patients enrolled in the ongoing TECTONICS intraoperative Anesthesiology Control Tower telemedicine trial at Barnes-Jewish Hospital will be excluded from this study

Primary outcomes:
measure: Improvement in administration of surgical antibiotic prophylaxis- intervention period
timeFrame: 3 months
measure: Improvement in administration of surgical antibiotic prophylaxis-after quality improvement intervention
timeFrame: 2 months
measure: Improvement in administration of surgical antibiotic prophylaxis
timeFrame: 8 months
Secondary outcomes:
measure: Surgical site infection rate
timeFrame: 8 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine/Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington Univeristy School of Medicine
name: Troy Wildes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03464929: Learning Curves for Airtraq Versus King Vision Laryngoscopes
Official title: Learning Curves for Airtraq Versus King Vision Laryngoscopes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation
Laryngoscopy
Lead sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Central de Asturias
name: Fundación Asturcor
First posted: 2018-03-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients submitted to elective surgery under general anesthesia.

Brief summary: Several videolaryngoscopes have been developed but few have been compared in terms of their learning curves and efficacy. The aim of this study is to compare the learning curves of Airtraq versus King Vision in a group of residents trained in direct laryngoscopy. Four residents will perform, after a short training in manikin, 8 intubations with each device. The sequence of use of the devices will be randomized. Outcome measures will be duration of intubation attempt, glottic visualization and percentage of intubation success.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status classification I-II.
* Elective surgery.
* General anesthesia required.

Exclusion Criteria:

* Bronchoaspiration risk.
* Pharmacological allergies.
* Craniofacial anomalies.
* Body mass index \> 30.
* Prior history of airway management complications.
* Presence of clinical signs predictive of difficult intubation.

Primary outcomes:
measure: Time for intubation
timeFrame: 60 seconds
measure: Glottic visualization
timeFrame: 60 seconds
measure: Intubation success
timeFrame: 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias (HUCA)
state: Principado De Asturias
Study officials:
affiliation: Hospital Universitario Central de Asturias
name: Félix Ezequiel Fernández-Suárez, MD
role: STUDY_DIRECTOR
References:
citation: Su YC, Chen CC, Lee YK, Lee JY, Lin KJ. Comparison of video laryngoscopes with direct laryngoscopy for tracheal intubation: a meta-analysis of randomised trials. Eur J Anaesthesiol. 2011 Nov;28(11):788-95. doi: 10.1097/EJA.0b013e32834a34f3.
citation: Savoldelli GL, Schiffer E, Abegg C, Baeriswyl V, Clergue F, Waeber JL. Learning curves of the Glidescope, the McGrath and the Airtraq laryngoscopes: a manikin study. Eur J Anaesthesiol. 2009 Jul;26(7):554-8. doi: 10.1097/eja.0b013e3283269ff4.
Clinical trial NCT05040529: Comparison Between Pure Laparoscopic Donor Right Hepatectomy and Convensional Donor Right Hepatectomy
Official title: Clinical Outcome of Living Donor Hepatectomy for Liver Transplantation: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Donors for Liver Transplantation
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A healthy person between the ages of 17 and 65 years who was willing to donate a liver was considered

Brief summary: Perioperative clincal outcome between PLDRH and conventional open donor right hepatectomy (ODRH) will be compared retrospectively.

Detailed description: the superiority of laparoscopic liver resection was well known in terms of reduced blood loss and minimized hospital stay compared with open liver resection. However, pure laparoscopic donor hepatectomy is a challenging procedure for beginner liver surgeons because of the major vessel preservation required during liver parenchymal transection. this study was designed to identify the superiority of laparoscopic donor hepatectomy.

Eligibility criteria: Inclusion Criteria:

* patients received right or right extended hepatectomy for liver donation at gangnam severance hospital

Exclusion Criteria:

* none

Primary outcomes:
measure: blood loss during hepatectomy
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severacne Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Jin Hong Lim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong SK, Lee KW, Choi Y, Kim HS, Ahn SW, Yoon KC, Kim H, Yi NJ, Suh KS. Initial experience with purely laparoscopic living-donor right hepatectomy. Br J Surg. 2018 May;105(6):751-759. doi: 10.1002/bjs.10777. Epub 2018 Mar 26.
Clinical trial NCT00446329: Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Papageorgiou General Hospital
Sponsor class: OTHER
First posted: 2007-03-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The 1st phase of the study will assess the acute biochemical response of PTH, calcium and phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per day.

The 2nd phase of the study designed to evaluate the long term effects of cinacalcet on BMD (bone mineral density)and the levels of PTH, calcium, phosphorus as well as its ability to control secondary hyperparathyroidism without simultaneous administration of other vitamin D compounds.


Eligibility criteria: Inclusion Criteria:

* Age older than 18 yrs
* On hemodialysis for at least 3 months (thrice weekly)
* iPTH \>300pg/ml or histological evidence of secondary hyperparathyroidism
* Calcium \> 8.1 mg/dl

Exclusion Criteria:

* Unstable clinical condition

Primary outcomes:
measure: Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients
timeFrame: one year period
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
Study officials:
affiliation: Papageorgiou General Hospital, Thessaloniki, Greece
name: Efstathios Mitsopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05385029: Fetal and Neonatal Thyroid in Pregnancies With Severe Acute Respiratory Syndrome Coronavirus 2 ( SARS- COV2 ) COVID-19
Official title: Thyroid Function Tests in Infants of COVID-19 Positive Pregnant Mothers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Dysfunction
Hypothyroidism
Hyperthyroidism
Keywords: TSH Thyroid- Stimulating Hormone
FT4 Free Thyroxine
COVID-19 Corona Virus Disease
PCR Polymerase Chain Reaction
SARS COV2 Severe Acute Respiratory Syndrome
mIU milli-International Unit
Lead sponsor: Security Forces Hospital
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All newborn babies delivered in Security Forces Hospital

Brief summary: The thyroid gland has been shown to be a common target for COVID 19 virus. Babies born to mothers positive for COVID 19 infections were noticed to have elevated thyroid stimulating hormone ( TSH ) levels on screening. Thyroid function tests were monitored in these babies to determine presence of temporary or permanent thyroid disorders following COVID 19 infections during pregnancy.

Detailed description: TSH estimation is carried out in all newborn babies in Saudi Arabia as a screening test for hypothyroidism. The first babies who were born to COVID 19 positive mothers were noticed to have significantly abnormal high TSH values. All the data and studies on the effect of COVID 19 on thyroid gland are from adult literature. Hence with these results of TSH in the the newborns we designed this observational study to monitor the thyroid functions in infants of COVID 19 positive mothers born in our hospital. The study confirmed presence of abnormal TSH and free thyroxine in these babies at birth and these babies were followed further after that for evidence of thyroid disorders.Results of thyroid functions in the babies who born in the same period of the study to mothers without COVID 19 infection were also recorded.

Eligibility criteria: Inclusion Criteria:

* All newborns

Exclusion Criteria:

* Babies with congenital malformations

Primary outcomes:
measure: Presence of Thyroid Dysfunction as Hypothyroidism or Hyperthyroidism
timeFrame: First measurement of TSH at birth to 24 hours. Then repeat TSH and FT4 after 48-72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Security Forces Hospital
state: Central
Study officials:
References:
Clinical trial NCT01517529: Evaluating the Role of Immune Responses in the Emergence of Protease Inhibitor Mutations
Official title: Evaluating the Role of the Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Hepatitis C
HCV
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-01-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators plan to enroll 20 human subjects with chronic hepatitis C virus infection from the outpatient clinic at the University of Cincinnati College of Medicine.

Brief summary: The major goal of this project is to identify the role of the immune responses in the emergence of protease inhibitor mutants during therapy.

Detailed description: Objective 1: Evaluate the role of the immune responses in determining the emergence of HCV NS3 resistance mutation during protease inhibitor therapy

Hypothesis 1 (HT 1): Low HLA binding to peptides containing protease inhibitor resistance mutations is associated with the emergence of protease inhibitor mutants during therapy and failure of the treatment.

Hypothesis 2 (HT 2): A hole in T cell repertoire may allow emergence of protease inhibitor mutants during protease inhibitor therapy which leads to loss of the immune responses to these mutants and failure of treatment.

Eligibility criteria: Inclusion Criteria: All chronically HCV-infected patients who fail peg-IFN and RBV therapy and are eligible for combined treatment with PI therapy will be enrolled. Briefly, this includes:

1. Male or female
2. Age 18 to 65
3. Chronic HCV infection evidenced by liver biopsy or persistent HCV viremia for \>6 months
4. Treatment experienced and classified as non-responder or relapser to prior interferon-based therapy.

Exclusion criteria:

1. Treatment naïve chronically HCV-infected patients.
2. Patients with a history of inflammatory bowel diseases (IBD) or suspected IBD, autoimmune diseases, including rheumatoid arthritis, and any patients on systemic immunomodulators.
3. Pregnancy
4. HIV

Primary outcomes:
measure: Number of Participants Who Completed Standard Treatment
timeFrame: 9 months
Secondary outcomes:
measure: Number of Participants Who Cleared the Virus
timeFrame: 9 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Mohamed Tarek. M Shata, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdel-Hameed EA, Rouster SD, Ji H, Ulm A, Hetta HF, Anwar N, Sherman KE, Shata MT. Evaluating the Role of Cellular Immune Responses in the Emergence of HCV NS3 Resistance Mutations During Protease Inhibitor Therapy. Viral Immunol. 2016 May;29(4):252-8. doi: 10.1089/vim.2015.0093. Epub 2016 Feb 17.
Clinical trial NCT02107729: The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic
Official title: The Importance of Needle Gauge for Pain During Injection of Local Anaesthetic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Needlestick Injuries
Keywords: Injections
Pain
Healthy volunteers
Lidocaine
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2014-04-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the influence of needle gauge on pain during injection of local anaesthetic. Healthy volunteers will be recruited, who will each receive three injections with either 21G, 23G or 27G subcutaneously on the abdomen. After each injection, the participants will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is anticipated that the pain will decrease with decreasing thickness of the needle. The aim of this study is to find a simple method for pain reduction that can be used in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years

Exclusion Criteria:

* Kidney, heart or liver disease
* Eczema or psoriasis on injection site
* Neuropathy
* Regular use of painkillers
* Hypersensitivity of Lidocaine
* Pregnancy
* Diabetes

Primary outcomes:
measure: Pain
timeFrame: 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Neuroscience, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Vilhjalmur Finsen, Prof md
role: STUDY_DIRECTOR
References:
citation: Wago KJ, Skarsvag TI, Lundbom JS, Tangen LF, Ballo S, Hjelseng T, Finsen V. The importance of needle gauge for pain during injection of lidocaine. J Plast Surg Hand Surg. 2016;50(2):115-8. doi: 10.3109/2000656X.2015.1111223. Epub 2015 Nov 23.
Clinical trial NCT02999529: Health Literacy Multi-media Study
Official title: Improving Patient Understanding of Key Terms Used to Describe Chemotherapy and Its Side Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Chemotherapy
Oncology
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Cancer patients are presented with a lot of information about their diagnosis and different treatment options, which can be confusing. The purpose of this study is to see if a simple video explanation of six words used to describe cancer treatment improves patient understanding of these words.

Detailed description: Cancer patients are presented with a lot of information about their diagnosis and different treatment options, which can be confusing. The purpose of this study is to see if a simple video explanation of six words used to describe cancer treatment improves patient understanding of these words.

Participants will be interviewed and asked the meaning of six words related to cancer treatment. Following the interview, participants will be shown a video about the meaning of the words. After viewing the video, participants will be re-interviewed to test how effective the video was at explaining the six words.

Eligibility criteria: Inclusion Criteria:

* Patients at Grady Memorial Hospital who is offered a consent to receive chemotherapy

Exclusion Criteria:

* Profession as a physician or nurse
* Non English speaking

Primary outcomes:
measure: Number of Correct Responses
timeFrame: Post Intervention (Up to ten minutes)
measure: Number of Incorrect Responses
timeFrame: Post Intervention (Up to ten minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Rebecca Pentz, PhD
role: PRINCIPAL_INVESTIGATOR
References: