louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02847195: Pupillometry in Pediatric Intensive Care Unit (PICU)
Official title: Evaluation of Pupillometry to Assess Analgesia in Children Unable to Communicate Verbally in Pediatric Intensive Care Unit (PICU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Intensive Care
Keywords: pediatric intensive care
pain assessment
tracheal aspiration
sedation
pupillometer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 66
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Assess the depth of sedation and analgesia in pediatric intensive care is critical to the management of intubated patients under mechanical ventilation. The responsiveness of the pupil is changed by the sedation and analgesia. Measuring the pupil diameter is proposed in anesthesia and intensive care to assess the quality of analgesia in adult population. Visually measuring the diameter of the pupil remains very imprecise, but this measure can be accurately and quickly performed thanks to portable devices called Pupillometers. Some devices including Algiscan® device (IdMed ) can measure in addition to the pupil diameter, the variation of pupil diameter, the latency of the pupillary reflex and the maximum speed of contraction. Pupillometry was tested in adult ICU patients, during painful and painless procedures \[1\]. In this study, pupillometry was more sensitive for detecting pain compared to the change in heart rate or bispectral index. The objective of this work is to perform measurements of pupil diameter during painful procedures (e.g. tracheal aspiration) in PICU. In parallel we will continue using the Comfort B-scale (has been validated for assessment of pain in children admitted to a pediatric intensive care unit \[2-5\] and compare the results of both types of assessment pain.


Eligibility criteria: Inclusion Criteria:

* children (age \< 18 years) hospitalized in PICU
* sedated because they are receiving mechanical ventilation,
* for whom parents (or their representatives) have given their oral consent after written information.

Exclusion Criteria:

* children receiving curare drugs
* with congenital or acquired neurological,
* with ophthalmologic pathology
* or who does not benefit from social insurance coverage.

Primary outcomes:
measure: pupillary diameter
timeFrame: Day 1
measure: Comfort B Score
timeFrame: Day 1
Secondary outcomes:
measure: Latency time
timeFrame: Day 1
measure: pupil diameter variation
timeFrame: Day 1
measure: diameter variation time
timeFrame: Day 1
Other outcomes:
Locations:
city: Bron
country: France
facility: service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon, 59 Boulevard Pinel
Study officials:
affiliation: Hospices Civils de Lyon
name: Fabienne BORDET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02862795: Human Papillomavirus Anal Infection
Official title: Human PapillomaVirus (HPV) Anal Infection: Study of Prevalence and Risk Factors Among 1000 Patients Benefiting From a Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Infection
Keywords: colonoscopy
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Human papillomavirus (HPV) are involved in up to 95 % of anal canal neoplastic lesions. Little is known about HPV carriage in anal canal previous to cancer occurrence in the population and pre-neoplastic lesions, and their risk factors. PAPILLAN is a prospective study that aims to study HPV infection (HPV low grade and high grade genotypes) prevalence in anal canal in a population non selected by its HIV status. In that purpose patients are prospectively recruited in a french university hospital gastroenterology unit and anal smears are collected during a colonoscopy with cytobrush.


Eligibility criteria: Inclusion Criteria:

* patients \> 18 years
* patients undergoing colonoscopy under general anesthesia for any purpose
* signed written consent

Exclusion Criteria:

* age under 18
* Absence of written consent.
* patients incapable of giving consent

Primary outcomes:
measure: anal canal HPV infection
timeFrame: at inclusion (the day of colonoscopy)
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon
city: Vesoul
country: France
facility: Centre Hospitalier Intercommunal de la Haute Saône
Study officials:
References:
Clinical trial NCT05973695: Effects of Clamshell Versus Gluteal Bridge Exercises
Official title: Effects of Clamshell Versus Gluteal Bridge Exercises on Low Back Pain, Gluteal Strength and Disability Due to Prolonged Sitting in Females With Gluteal Amnesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Crossed Syndrome
Keywords: gluteal weakness
disability
pain
gluteal amnesia
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 32
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gluteal amnesia is a "condition" where the individual is believed to have lost the ability to contract their gluteal muscles - generally the gluteus maximus, though some report it as the gluteus medius. This can take many different names, such as "dead butt", "sleeping glutes", or glutes that are "turned off".Since the gluteus medius normally helps stabilize the pelvis, gluteal amnesia can lead to lower back pain and hip pain, as well as knee and ankle issues, as the body tries to compensate for the imbalance.

Detailed description: A Randomized controlled trial will be conducted at Jinnah Hospital Physiotherapy Clinic \& Boston Physiotherapy and wellness Clinic through consecutive sampling technique on 32 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A \& group B. Group A will be treated with clamshell exercises at the frequency of 3 sets with 10 repetitions 3 times/ week with baseline treatment. Group B will be treated with gluteal bridge and baseline treatment. Baseline treatment for both groups will be given Hot pack at low back for 10 minutes and Quadriceps and hamstring stretching 3 times with 30 seconds hold. Outcome measures will be conducted through pain, disability and quality of life questionnaire after 6 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro -Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility criteria: Inclusion Criteria:

* • Female between the ages of 20 to 40 years

  * Prolonged sitting hours \>4 hours.
  * Examination- Symptoms provoked by low back movement.
  * Positive Gluteal strength test
  * Positive SLR for hamstring tightness
  * Positive Thomas test for Rectus femoris tightness.

Exclusion Criteria:

* • Osteoporosis

  * Malignancy
  * Vertebral fractures
  * Pervious or scheduled surgery
  * Trauma
  * Pregnancy
  * Psychological conditions

Primary outcomes:
measure: Numerical Pain Rating scale (NPRS)
timeFrame: upto 4 weeks
measure: Oswestry disability score
timeFrame: upto 4 weeks
measure: Quality of Life EQ-5D
timeFrame: upto 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah hospital
state: Punjab
Study officials:
affiliation: Riphah International University,Lahore
name: Samrood Akram, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01344395: Use of Local Infiltration Analgesia Following Total Hip Arthroplasty
Official title: Local Infiltration Analgesia in Total Hip Arthroplasty - Efficacy of Multiple Bolus Injections With Ropivacaine and Ketorolac
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2011-04-29
Enrollment: 80
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: The primary aim of this study is to evaluate if multiple postoperative administrations with a solution of ropivacaine, ketorolac and epinephrine into the operating field through a catheter would affect morphine consumption. Secondary end-points are pain intensity, side effects and length of stay.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for total hip arthroplasty
* Patients \> 18 years of age
* Signed written informed consent
* Spinal anaesthesia

Exclusion Criteria:

* Allergy towards study drugs
* Rheumatoid arthritis
* Body Mass Index \> 35 (severe obesity)
* Pregnancy or nursing women
* Regular opioid use
* Patients who can not read or understand danish

Primary outcomes:
measure: Morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Pain intensity
timeFrame: 24 hours postoperatively
measure: Postoperative nausea
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Kjeld Søballe, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00410995: Effects of Naproxen on Physical Performance
Official title: Effects of Naproxen on Physical Performance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Healthy
Keywords: Physically fit volunteers
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2006-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of daily use of Naproxen (a commonly used over-the-counter NSAID) on the physical performance of athletes, as measured by maximum oxygen consumption.


Eligibility criteria: Inclusion Criteria:

1. Age equal to or greater than18 years of age
2. No history of allergy or adverse reaction to any NSAID
3. No use of any NSAID in past 2 weeks
4. No history of peptic ulcer disease (PUD), gastroesophageal disease (GERD), or gastritis
5. No major medical history including but not limited to diabetes, hypertension, asthma, kidney disease and coronary artery disease
6. Currently not taking any medication including oral contraceptives

Exclusion Criteria:

1. Age \< 18 years of age
2. History of allergy or adverse reaction to any NSAID
3. Use of any NSAID in past 2 weeks
4. History of a bleeding disorder
5. History of PUD, GERD, or gastritis
6. Pregnant
7. A medical history of diabetes, hypertension, asthma, kidney disease or coronary artery disease
8. Taking any medication including oral contraceptives

Primary outcomes:
measure: Effects on physical performance in terms of maximum oxygen consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Family Practice - CMT
state: Oklahoma
Study officials:
affiliation: University of Oklahoma-Tulsa
name: LaMont Cavanagh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06632795: The Relationship Between Emotional Intelligence, Social Behavior, Sleep Quality and Academic Success in Students Studying in Health-Related Departments
Official title: The Relationship Between Emotional Intelligence, Social Behavior, Sleep Quality and Academic Success in Students Studying in Health-Related Departments
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: University Students
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 500
Sex: ALL
Minimum age (years): 17
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: University students studying health-related departments

Brief summary: This study aims to examine the relationships between emotional intelligence, positive social behavior, sleep quality, and academic achievement among students enrolled in health-related academic programs. Specifically, the study will investigate how emotional intelligence levels influence students' social behaviors and academic performance, while also assessing the role of sleep quality in these variables. Data will be collected using the Emotional Intelligence Scale, the Positive Social Behavior Scale, and the Epworth Sleepiness Scale. The findings of this study are expected to provide valuable insights into how emotional intelligence and sleep quality impact students' academic success and social behavior.


Eligibility criteria: Inclusion Criteria:

* Being a university student in health-related departments

Exclusion Criteria:

* Having any diagnosed physical or psychological illness

Primary outcomes:
measure: Emotional intelligence scale
timeFrame: Two months
measure: Prosocial behavior scale
timeFrame: Two months
measure: Epworth sleepiness scale
timeFrame: Two months
Secondary outcomes:
measure: Academic Success Score
timeFrame: Two month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00492895: Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients
Official title: Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Cancer
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2007-06-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Photosensitivity of the skin to UVA and UVB will be determined

Detailed description: Photosensitivity of the skin to UVA and UVB in renal transplant recipients with and without azathioprine will be determined. Azathioprine will be discontinued and photosensitivity determined after a wash-out period of three months

* Trial with medicinal product

Eligibility criteria: Inclusion criteria:

* Renal transplant recipients under azathioprin

Exclusion criteria:

* Treatment with Prograf (Tacrolimus)

Primary outcomes:
measure: Photosensitivity of the skin to UVA and UVB
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Clinic for Dermatology, University Hospital of Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Günther Hofbauer, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hofbauer GF, Attard NR, Harwood CA, McGregor JM, Dziunycz P, Iotzova-Weiss G, Straub G, Meyer R, Kamenisch Y, Berneburg M, French LE, Wuthrich RP, Karran P, Serra AL. Reversal of UVA skin photosensitivity and DNA damage in kidney transplant recipients by replacing azathioprine. Am J Transplant. 2012 Jan;12(1):218-25. doi: 10.1111/j.1600-6143.2011.03751.x. Epub 2011 Sep 22.
Clinical trial NCT01508481: Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes
Official title: Vitamin D Inadequacy is Associated With Incidence of Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Vitamin D
Diabetes
pancreas beta cell function
insulin resistance
Deficiency of Vitamin D3
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 1500
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants, aged over 30 years, are recruited from Korea, between January 2006 and December 2011. Participants are at high risk for type 2 diabetes, as they are recruited on the basis of the presence of one or more risk factors for diabetes, including obesity, hypertension, dislipidemia, and a family history of diabetes. Participants are contacted every 6 month after the baseline visit to update contact information and collect data on major health events. Participants are invited to return to the clinic examination centers after 3 years for follow-up assessments.

Brief summary: Emerging evidence suggests that vitamin D \[25-hydroxyvitamin D; 25(OH)D\] may play a role in the etiology of type 2 diabetes. Vitamin D levels are lower in those with type 2 diabetes and impaired glucose tolerance (IGT) compared with those with normal glucose tolerance (NGT). In addition, a few prospective studies have shown a significant inverse association of baseline serum 25(OH)D with incident diabetes. To date, however, the exact mechanisms through which vitamin D affects diabetes risk are not yet fully known, particularly whether vitamin D plays a role in insulin resistance (IR) and/or b-cell dysfunction, the main pathophysiological disorders underlying type 2 diabetes. So, the investigators plan to examine the prospective associations of baseline vitamin D \[25-hydroxyvitamin D; 25(OH)D\] with insulin resistance (IR), b-cell function, and glucose homeostasis in subjects at risk for type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* one or more risk factors for diabetes, including:

  * obesity
  * hypertension
  * dislipidemia
  * a family history of diabetes

Exclusion Criteria:

* previous diagnosed diabetes
* vitamin D supplement.

Primary outcomes:
measure: Incidence of diabetes
timeFrame: 5 years
Secondary outcomes:
measure: Pancreatic beta cell function
timeFrame: 5 years
measure: Insulin resistance
timeFrame: 5 years
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo Lim, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim S, Kim MJ, Choi SH, Shin CS, Park KS, Jang HC, Billings LK, Meigs JB. Association of vitamin D deficiency with incidence of type 2 diabetes in high-risk Asian subjects. Am J Clin Nutr. 2013 Mar;97(3):524-30. doi: 10.3945/ajcn.112.048496. Epub 2013 Jan 30.
Clinical trial NCT03393481: Prevention of Thromboembolic Events in Total Knee Replacement Patients
Official title: A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Active-controlled Phase 2 Study to Compare the Efficacy and Safety of s.c. MAA868 Versus s.c. Enoxaparin in Adult Patients Undergoing Unilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Thrombotic Disorders
Keywords: biologic,
venous thromboembolism,
unilateral knee arthroplasty
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2018-01-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to find out whether MAA868, is able to prevent blood clots following your medical condition (surgery for knee replacement)


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo elective unilateral total knee arthroplayts (TKA)
* Willing to comply with study requirements including bilateral venography at Day 12 ± 2 days
* Body weight between 50 kg and 130 kg inclusive.
* Normal aPTT, PT, INR at screening

Exclusion Criteria:

History of arterial or venous thromboembolism; abnormally extended primary or secondary bleeding after trauma or intervention, stroke, transient ischemic attack or traumatic or non-traumatic intracranial bleed; bleeding disorder; MI or unstable angina pectoris within 12 months of the screening; Uncontrolled hypertension (SBP/DBP ≥ 150/95 mmHg at the screening).

Medications that increase the risk of bleeding, including antiplatelet (such as aspirin), anticoagulant and fibrinolytic agents; eGFR \< 60 mL/min/1.73m2; Poorly controlled diabetes (HbA1C \>10%); Liver dysfunction (ALT/AST \>3 xULN or TBL \>2 x ULN); BMI ≥ 40 kg/m2

Primary outcomes:
measure: Number of patients with confirmed composite endpoint
timeFrame: Day 14
Secondary outcomes:
measure: Number of patients with composite bleeding
timeFrame: Day 1 to Day 50
measure: Number of patients with composite venous thromboembolic events (VTE)
timeFrame: Day 1 to Day 110
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06855381: Ultrasound-guided Interscalene Brachial Plexus Block: Single Bolus Vs Continuous Catheter Placement in Arthroscopic Rotator Cuff Repair
Official title: Ultrasound-guided Interscalene Brachial Plexus Block: Single Bolus Injection Versus Continuous Catheter Placement in Arthroscopic Rotator Cuff Repair-a Prospective Randomized Unblinded Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anesthesia
Keywords: interscalene block, pain management, regional anesthesia, shoulder arthroscopy
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Shoulder arthroscopy is a minimally invasive procedure frequently used for rotator cuff repair. Patients may experience severe postoperative (PO) pain, that can last for a month and can influence successful rehabilitation. Our study aimes to evaluate the effectiveness of interscalene brachial plexus single-shot (ISBSS) versus continuous interscalene brachial plexus block (ISBC) in controlling perioperative pain and avoiding PO pain chronicization. This prospective randomized unblinded trial hypothesizes that the PO perineuronal infusion using a continuous ambulatory delivery device pump gives better pain control and outcomes than ISBSS during the long-term follow-up period.

Detailed description: Blocks will be performed under ultrasound guidance with 15 - 20 mL of 0.75 % ropivacaine.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesia (ASA) physical status of 1 to 2,
* Body Mass Index (BMI) of less than 30 kg/m²,
* paitents undergoing shoulder arthroscopy for small to medium rotator cuff tears.

Exclusion Criteria:

* skin infection on the puncture site,
* coagulopathy
* brachial plexus neuropathy
* alcohol or drug abuse
* diabetes
* severe lung disease
* history of allergy to one or more study drugs.

Primary outcomes:
measure: Pain severity
timeFrame: 24 hour, 48 hour, 72 hour, 7 day
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: Policlinico
Study officials:
References:
citation: Uno T, Mura N, Yuki I, Oishi R, Takagi M. The effect of continuous interscalene brachial plexus block for arthroscopic rotator cuff repair. Asia Pac J Sports Med Arthrosc Rehabil Technol. 2024 Feb 2;36:6-12. doi: 10.1016/j.asmart.2024.01.004. eCollection 2024 Apr.