louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03707964: Crisis Resource Management Improvement Through Intellectual Questioning of Authority
Official title: Crisis Resource Management Improvement Through Intellectual Questioning of Authority
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Education, Simulation, Crisis Resource Management
Keywords: Medical Education
Simulation
Crisis Resource Management
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized controlled trial examining the effectiveness of a teaching intervention on residents' and medical students' ability to challenge clearly wrong decisions by a superior during a simulated life-threatening crisis. Participants will be randomly allocated into the control or intervention arm. The intervention arm will receive education on crisis resource management (CRM) and teaching targeting the cognitive skills required to monitor and challenge a superior's decision, and conflict resolution tools. Participants will then take part in a simulation scenario 2 to 4 weeks later and will be assessed based on 6 challenge points, followed by a debrief session.


Eligibility criteria: Inclusion Criteria:

* Medical officers or Internal medicine, surgical and emergency medicine residents who are in their 2nd post-graduate year of training, or
* Phase V medical students from Yong Loo Lin School of Medicine, National University of Singapore

Exclusion Criteria:

* Refusal for informed consent, or
* Refusal for video recording during simulation sessions

Primary outcomes:
measure: Effect of a teaching intervention on participants' ability to challenge clearly wrong decisions by a superior during a simulated life-threatening crisis
timeFrame: 20 minutes
Secondary outcomes:
measure: Influence of the confederate's gender on participant's ability to challenge incorrect decisions
timeFrame: 20 minutes
Other outcomes:
measure: Qualitative analysis of themes surrounding hierarchy and challenging authority
timeFrame: 10 minutes
Locations:
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
Study officials:
affiliation: National University Hospital, Singapore
name: Gene Chan, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04945564: Covid-19 Patients Management During Home Isolation
Official title: Covid-19 Patients Management During Home Isolation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will investigate management of Covid-19 patients in home isolation.

Detailed description: A clinical trial concerned with the treatment of home isolated COVID-19 patients

Eligibility criteria: Inclusion Criteria:

* Covid-19 patients American Society of Anesthesiologists (ASA) class I \>= 21 years old \<= 40 years old

Exclusion Criteria:

* Not being consistent with home-isolation regimen

Primary outcomes:
measure: Time for recovery of pH
timeFrame: 24 hours
measure: Time for recovery of PaO2
timeFrame: 24 hours
measure: Time for recovery of PaCO2
timeFrame: 24 hours
measure: Chest CT scan
timeFrame: Baseline
measure: Chest CT scan
timeFrame: 1 day post-treatment
Secondary outcomes:
measure: Time for recovery of Temperature
timeFrame: 24 hours
measure: Time for recovery of Respiratory Rate
timeFrame: 24 hours
measure: Time for recovery of Oxygen Saturation
timeFrame: 24 hours
measure: Time for recovery of Heart Rate
timeFrame: 24 hours
measure: Time for recovery of Blood Pressure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: A. Sedky
Study officials:
References:
Clinical trial NCT06431464: Tattoo Particles: Picosecond Laser Versus Nanosecond Laser
Official title: In Vivo Analysis of Tattoo Particles After Picosecond Laser Compared to Nanosecond Laser
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tattoo; Pigmentation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department

Brief summary: - For treating unwanted tattoos, the gold standard treatment is a nanosecond or picosecond laser. However, comparative microscopic analysis is limited. Therefore, the aim of the present study is to analysis morphological changes of tattoo particles and surrounding tissue in human skin.


Eligibility criteria: Inclusion Criteria:

- healthy patients who plan a laser treatment of their unwanted tattoo/ tattoos at our department

Exclusion Criteria:

* laser pretreatment of their tattoos to be treated
* pregnancy, breast feeding
* open wound on the area to be treated

Primary outcomes:
measure: Size of intercellular spaces
timeFrame: 6 weeks and 12 weeks post-treatment
measure: Size of keratinocytes
timeFrame: 6 weeks and 12 weeks post-treatment
measure: Size of tattoo particles
timeFrame: 6 weeks and 12 weeks post-treatment
measure: Distribution of tattoo particles
timeFrame: 6 weeks and 12 weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References:
citation: Nguyen L, Mess C, Schneider SW, Huck V, Herberger K. In vivo visualisation of tattoo particles using multiphoton tomography and fluorescence lifetime imaging. Exp Dermatol. 2022 Nov;31(11):1712-1719. doi: 10.1111/exd.14646. Epub 2022 Jul 25.
Clinical trial NCT03438864: Acute Effects of Interferential Current on Edema, Pain and Muscle Strength in Patients With Distal Radius Fracture
Official title: Acute Effects of Interferential Current on Edema, Pain and Muscle Strength in Patients With Distal Radius Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius Fractures
Edema
Pain
Keywords: Radius fracture, Interferential current, edema, pain
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interferential current is a form of electrotherapy that is obtained by placing two different plates that produce medium frequency waveform current, resulting in a low frequency interferential waveform in deeper tissues. It was shown interferential current electrotherapy is beneficial for reduction of traumatic edema in tissues and pain control.

Patients with conservatively managed distal radius fractures were recruited after casts are shed, and were treated with one session(30 minutes) of different protocols of interferential current electrotherapy. Before and after therapy, they were evaluated with volumetry, hand grip strength and visual analogue scale for pain.


Eligibility criteria: Inclusion Criteria:

* Conservatively managed distal radius fractures

Exclusion Criteria:

* Secondary conditions associated with edema(renal failure, congestive heart failure etc)
* Complex regional pain syndrome
* Compartment syndrome
* Contraindications for electrotherapy(cardiac pacemaker, thrombosis, pregnancy etc)
* Mental state unfit for electrotherapy
* Having treated with electrotherapy before

Primary outcomes:
measure: Volumetry
timeFrame: 30 minutes
measure: Visual Analogue Scale
timeFrame: 30 minutes
measure: Hand Grip Strength
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01214564: Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis
Official title: A Phase 2a, Multi-Centre, Open-Label Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis on Non-head Locations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seborrheic Keratosis
Keywords: PEP005
Peplin
Seborrhoeic Keratosis
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.


Eligibility criteria: Inclusion Criteria

1. Patient is male or female and at least 18 years of age.
2. Female patients must be of either:

   * Non-childbearing potential, provided there is a laboratory confirmed serum follicle stimulating hormone (FSH) level ≥ 40mIU/ml or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus); or
   * Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy.
3. Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures, including any alteration of medications in preparation for study entry.
4. Patient has agreed to allow photographs of the selected treatment lesions to be taken and used as part of the study data package.

Exclusion Criteria

1. Known sensitivity or allergy to any of the ingredients in PEP005 (ingenol mebutate)Gel.
2. Current enrolment or participation in a clinical research study within 30 days of entry into this study.

Primary outcomes:
measure: To evaluate the safety of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
timeFrame: Day 43
Secondary outcomes:
measure: To determine the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.
timeFrame: Day 43
Other outcomes:
Locations:
city: Kogarah
country: Australia
facility: Southderm Pty Ltd
state: New South Wales
city: Woolloongabba
country: Australia
facility: Specialist Connect
state: Queensland
Study officials:
References:
Clinical trial NCT01907464: Bone Loss in Patients With Anorexia Nervosa
Official title: Physiopathology of Bone Loss in Young Patient With Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Anorexia Nervosa
Keywords: Anorexia nervosa
Bone mineral density
Teenagers or young women
Bone remodelling markers
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 320
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 38
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Nutritional deprivation of adolescent girls with anorexia nervosa (AN) reduces the bone mass acquisition. A better understanding of this process would improve the medical treatment of bone alteration and its long-term consequences.

160 patients (age \< 38 yr) with AN and 160 age-matched controls (CON) will be enrolled in this study. The areal bone mineral density (aBMD) will be determined using dual-X-ray absorptiometry. Calciotropic hormones, bone turnover markers will be concomitantly evaluated.


Eligibility criteria: Inclusion Criteria:

* Informed Consent
* Health Insurance regimen or benefit from an health insurance regimen
* Aged from 14 to 38 years old
* Women
* No pregnant

Specific inclusion criteria for patient:

Patient suffering from anorexia nervosa defined by criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)

Specific inclusion criteria for controls:

* Normal menstrual cycles,
* No lifetime history of eating disorders,
* BMI between 18 and 25 kg/m²

Exclusion Criteria:

* use of treatments may be modify bone mass (bisphosphonates,...)
* Disease or treatment may be induce osteoporosis
* In exclusion period in relation with another study
* Law protected subject

Primary outcomes:
measure: Dual-X-ray absorptiometry (DEXA)
timeFrame: at Day 0 (time of the inclusion visit)
Secondary outcomes:
measure: Biological parameters identification
timeFrame: At day 0 (time of the inclusion visit)
measure: clinical parameters identification
timeFrame: At Day 0 (at time of the the inclusion visit)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Département d'Endocrinologie Diabète
Study officials:
affiliation: University Hospital, Montpellier
name: Patrick PL LEFEBVRE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00876564: Rogaland Trauma System Study
Official title: Trauma System Evolution. A Quality Improvement Study of the Trauma System at Stavanger University Hospital, Norway.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Keywords: Triage precision
Lead sponsor: Norwegian Air Ambulance Foundation
Sponsor class: OTHER
First posted: 2009-04-06
Enrollment: 1812
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to improve performance, Stavanger University Hospital (SUH) reorganized key system structures and introduced in 2009 mandatory documentation of field Revised Trauma Score on trauma patients, tiered trauma team activation and new guidelines for field triage. Through a before and after study, the investigators aim to measure how the quality improvement initiative will influence structure, process and outcomes variables.


Eligibility criteria: Inclusion Criteria:

* Included in trauma registry

Exclusion Criteria:

* Excluded from trauma registry

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
state: Rogaland
Study officials:
affiliation: Norwegian Air Ambulance Foundation
name: Marius Rehn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rehn M, Lossius HM, Tjosevik KE, Vetrhus M, Ostebo O, Eken T; Rogaland Trauma System Study Collaborating Group. Efficacy of a two-tiered trauma team activation protocol in a Norwegian trauma centre. Br J Surg. 2012 Feb;99(2):199-208. doi: 10.1002/bjs.7794. Epub 2011 Dec 20.
Clinical trial NCT03281564: Quality of Life After Laparoscopic Removal of Essure®
Official title: Prospective Study of Quality of Life After Laparoscopic Removal of Essure®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraceptive Device; Complications
Quality of Life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 474
Sex: FEMALE
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: Patients with laparoscopic removal of Essure®

Brief summary: A lot of patients seem to complain after hysteroscopic tubal occlusion by Essure® device with a worce quality of life. Investigators' hypothesis is that Essure® laparoscopic removal may improve quality of life. This prospectice study aim to assess the quality of life 1, 3, 6 and 12 months after Essure® removal.


Eligibility criteria: Inclusion Criteria:

* women aged 18 years or more
* patients with Essure® sterilization device
* surgical removal of Essure® with bilateral salpingectomy by laparoscopy

Exclusion Criteria:

* interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, evolutive disease, etc.
* impaired lower-limb range of motion preventing positioning for surgery
* inability to understand information provided
* prisoner or under administrative supervision.

Primary outcomes:
measure: Quality of life 1 month after laparoscopic removal of Essure®
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT02241564: Malignancies in Transplanted Patients
Official title: Follow-up of Malignancies in Transplanted Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Keywords: Immunosuppression
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 95
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: Kidney, pancreas or liver transplanted patients in the Uppsala/Örebro region with a diagnosed malignancy pre or post transplantation

Brief summary: The aim of the project is to improve the overall treatment and outcome of renal, pancreas or liver transplanted patients who have encountered a malignancy by a structured treatment program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive treatment, follow-up and evaluation of the program.


Eligibility criteria: Inclusion Criteria:

* Patients willing and capable of giving written informed consent of participation in the project
* Patients with a previous diagnosed or presently diagnosed or reoccurrence of a malignancy (other then basal cell carcinoma)

Exclusion Criteria:

* Patients with a primary liver cancer as cause of the transplantation

Primary outcomes:
measure: Patient survival
timeFrame: 12 months, 2 years, 3 years
Secondary outcomes:
measure: Graft survival
timeFrame: 12 months, 2 years, 3 years
measure: ImmuKnow Assay value
timeFrame: 12 months
measure: Tumour progression/regression/reoccurrence
timeFrame: 12 months, 2 years, 3 years
measure: Maintained switch of immunosuppression from calcineurin inhibitor to mTOR inhibitor
timeFrame: 3 years
measure: Kidney function
timeFrame: 12 months, 2 years, 3 years
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of Surgery, Section of Transplantation Surgery, Uppsala University Hospital
Study officials:
References:
citation: Hellstrom V, Lorant T, Dohler B, Tufveson G, Enblad G. High Posttransplant Cancer Incidence in Renal Transplanted Patients With Pretransplant Cancer. Transplantation. 2017 Jun;101(6):1295-1302. doi: 10.1097/TP.0000000000001225.
citation: Hellstrom VC, Enstrom Y, von Zur-Muhlen B, Hagberg H, Laurell A, Nyberg F, Backman L, Opelz G, Dohler B, Holmberg L, Tufveson G, Enblad G, Lorant T. Malignancies in transplanted patients: Multidisciplinary evaluation and switch to mTOR inhibitors after kidney transplantation - experiences from a prospective, clinical, observational study. Acta Oncol. 2016 Jun;55(6):774-81. doi: 10.3109/0284186X.2015.1130855. Epub 2016 Jan 29.
Clinical trial NCT02275364: Functional Magnetic Resonance Imaging (fMRI) Study of Nasal Strips in Nasal Congestion
Official title: A Magnetic Resonance Imaging Study of Nasal Strips in Subjects With Nasal Congestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasal Congestion
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to evaluate the effect of the nasal strip (relative to the placebo strip) on the nasal passages using anatomical MRI scans and to demonstrate the effect of the strip on breathing correlated cortical activity, using interoceptive fMRI task and analysis techniques derived from physiological data collected during scanning.


Eligibility criteria: Inclusion Criteria:

* Participants with a self-rating of at least 3 to 8 for nasal congestion on the numerical rating scale
* Participants with a nasal congestion frequency score of 1, 2, 3 or 4.

Exclusion Criteria:

* Evidence of obstructive nasal polyps, nasal tract structural malformations, visible open sores, sunburn, irritation, eczema or chronic skin condition on the face or nose
* Use of any medications like nasal decongestant, alpha adrenergic drugs, glucocorticoids and any current treatment which in the opinion of the investigator will affect nasal congestion
* Known or suspected intolerance or hypersensitivity to the study materials.

Primary outcomes:
measure: Anatomical Measures : Cross Sectional Area
timeFrame: Upto 2.5 hours
measure: Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task
timeFrame: Upto 2.5 hours
measure: Anatomical Measure: Volume (Single Volume Reading)
timeFrame: Upto 2.5 hours
measure: Cerebral Blood Flow (CBF)
timeFrame: Upto 2.5 hours
measure: Anatomical Measures: Volume (Multiple Volume Reading)
timeFrame: Upto 2.5 hours
measure: Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis)
timeFrame: Upto 2.5 hours
Secondary outcomes:
measure: Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)
timeFrame: Upto 2.5 hours
measure: Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application
timeFrame: Upto 30 minutes
measure: VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration
timeFrame: Upto 2 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imanova Centre for Imaging Sciences
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: