louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05752305: Use of Corticosteroids in Third Molar Surgery
Official title: Effect of Preoperative Administration of Dexamethasone Versus Methylprednisolone in Surgical Extraction of Retained Lower Third Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Inflammation
Pain, Postoperative
Trismus
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain, that lead to a decrease in patients' quality of life. Therefore, the use of drugs is essential to reduce the morbidity associated with surgery, with NSAIDs and corticosteroids being the most commonly used drugs.

Detailed description: Surgical extraction of retained lower third molars is associated with the development of postoperative complications, including inflammation, trismus and postoperative pain. Traditionally, NSAIDs have been used for the treatment of postoperative pain and inflammation, although corticosteroids are increasingly used in oral surgery, as they have proven to be clinically effective in reducing postoperative complications without causing serious adverse effects. Although numerous studies have been carried out comparing different corticosteroids in order to determine which of them is the most effective, there is still no clinical protocol regulating the use of these drugs in oral surgery. Therefore, this clinical trial is based on comparing two of the most studied corticosteroids used in oral surgery to date: dexamethasone and methylprednisolone.

This study is based on the preoperative administration of 8mg of dexamethasone or 40mg of methylprednisolone via submucosa, randomly, in patients undergoing surgical extraction of a retained lower third molar, to determine which of these two drugs is more effective in the prevention of inflammation, trismus and postoperative pain.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Indication for surgical extraction of a retained lower third molar

Exclusion Criteria:

* Patients treated with corticosteroids in the last 3 months
* Patients treated with NSAIDs in the last 7 days
* Patients with hypersensitivity to the drug
* Patients with a medical condition that contraindicates the administration of the drug

Primary outcomes:
measure: Postoperative inflammation following third molar surgical extraction
timeFrame: 7 days
measure: Postoperative trismus following third molar surgical extraction
timeFrame: 7 days
measure: Postoperative pain following third molar surgical extraction
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Unai Fernández Martín
Study officials:
affiliation: Universidad de Granada
name: Unai Fernández
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06260605: Complications of Diabetes With Puzzles
Official title: The Effect of Diabetes Complications Education Given With Puzzles on the Knowledge Level of Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Complications
Keywords: nursing students
puzzles
diabetes
Lead sponsor: Bilecik Seyh Edebali Universitesi
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, it was aimed to investigate the effect of diabetes complications training on endocrine system diseases and nursing care in the Internal Medicine Nursing course on the knowledge level of nursing students.

Detailed description: Puzzles, which are among the active learning tools, are frequently preferred today because they make learning fun, are economical, improve problem-solving skills and offer understandable learning. The student\&#39;s involvement in a fun game, his effort to find the correct information, and the feedback he receives afterwards have an important place in terms of learning. It develops students\&#39; decision-making power with a critical perspective. Puzzles increase students\&#39; motivation and self-confidence by turning complex concepts into a hobby. The use of the puzzle technique in learning concepts related to theoretical knowledge is among the studies carried out in recent years. The puzzle technique is used in many fields such as pharmacology in nursing education (Shawahna \&amp; Jaber, 2020), child health and diseases (Kaynak et al., 2023), pain management (Köse Tosunöz \&amp; Deniz Doğan, 2023), teaching in nursing (Kalkan et al., 2022). It has been shown to have a positive effect on learning information. In this study, it was aimed to investigate the effect of diabetes complications training on endocrine system diseases and nursing care in the Internal Medicine Nursing course on the knowledge level of nursing students.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in research
* Having course continuity

Exclusion Criteria:

* Not volunteering to participate in the research

Primary outcomes:
measure: Education
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bilecik
country: Turkey
facility: Bilecik Şeyh Edebali University
state: Merkez
Study officials:
References:
Clinical trial NCT03152305: Intracranial Pressure During Migraine
Official title: Measure of Intracranial Pressure Variations During Migraine Attacks
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Menstrual Migraine
Keywords: Migraine
Intracranial pressure
Headache
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Womens presenting with regular menstrual migraine treated with triptans will be included in the study. Self-measure of ICP will be performed outside and during menstrual migraine attacks. The potential variations will be compared to the measures done on matched healthy women outside and during menses.

Brief summary: An increase in intracranial pressure (ICP) during migraine attacks is possible and could contribute to pain initiation and maintenance. From now on, it was not possible to measure ICP in a non-invasive way. The development of a new tool allows non-invasive self-measures of ICP variations. Thus, it is possible for the first time to look for such ICP variations during migraine attacks and to conclude if this mechanism is implied in the pathophysiology of migraine.

Detailed description: Womens presenting with regular menstrual migraine treated with triptans will be included in the study. Self-measure of ICP will be performed outside and during menstrual migraine attacks. The potential variations will be compared to the measures done on matched healthy women outside and during menses.

Eligibility criteria: Inclusion Criteria:

* 18 to 50 non menopausal women
* Menstrual migraine
* Using a triptan as usual treatment to relieve attacks
* Usual triptan efficacy although recurrence is possible

Exclusion Criteria:

* Disease of the ear
* Intracranial hypertension
* Chronic daily headache
* Use of topiramate or acetazolamide
* Triptans used more than 10 days/month
* Analgesic drug used more than 15 days/month
* Uncontrolled high blood pressure
* BMI \>30
* Ongoing allergic rhinitis or flu

Primary outcomes:
measure: Intracranial pressure variations
timeFrame: during menstrual migraine attacks
Secondary outcomes:
measure: Relationships between ICP variations and clinical parameters
timeFrame: during menstrual migraine attacks
measure: Relationships between ICP variations and pain relief
timeFrame: during menstrual migraine attacks
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
state: Auvergne
Study officials:
References:
Clinical trial NCT03031405: The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories
Official title: The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories: A Model to Understand the Development of Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Memories
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Central Institute of Mental Health, Mannheim
First posted: 2017-01-25
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to examine whether oxytocin and oxytocin receptor gene polymorphism affect the development of intrusive memories, a cardinal symptom of PTSD.


Eligibility criteria: Inclusion Criteria:

* healthy female volunteers
* German on a native level

Exclusion Criteria:

* former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
* any physical illnesses
* any medication intake (except oral contraceptive)
* history of traumatic experience, e.g. history of sexual abuse or rape
* pregnancy or lactation period
* follicular phase of menstrual cycle for all women not using oral contraceptives

Primary outcomes:
measure: Intrusive memories
timeFrame: four consecutive days
Secondary outcomes:
measure: Noradrenergic System (measured with salivary alpha-amylase - u/ml)
timeFrame: Day 1
measure: Genetic polymorphism
timeFrame: four consecutive days
measure: Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)
timeFrame: Day 1
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
Study officials:
affiliation: Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
name: Stefan Roepke, PD Dr.
role: STUDY_DIRECTOR
References:
citation: Schultebraucks K, Maslahati T, Wingenfeld K, Hellmann-Regen J, Kraft J, Kownatzki M, Behnia B, Ripke S, Otte C, Roepke S. Intranasal oxytocin administration impacts the acquisition and consolidation of trauma-associated memories: a double-blind randomized placebo-controlled experimental study in healthy women. Neuropsychopharmacology. 2022 Apr;47(5):1046-1054. doi: 10.1038/s41386-021-01247-4. Epub 2021 Dec 9.
Clinical trial NCT02667405: The Short Term Effect of Hot Packs and Whirlpool for Increasing Total Active Motion at the Wrist
Official title: The Short Term Effect of Hot Packs and Whirlpool for Increasing Total Active Motion at the Wrist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 61
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: This study investigates the effect of hot packs versus whirlpool and exercise for patients with distal radius fracture (DRF). Patients with recently healed DRF are randomized into two groups, with one group receiving hot packs during therapy and the other immersing the arm in a whirlpool for 3 consecutive therapy visits. The effect of these modalities on range of motion and volume of the hand are evaluated, with measurements taking place before and immediately after heat during each visit.

Detailed description: This study investigates the short term effect of hot packs versus whirlpool and exercise for patients with distal radius fracture (DRF) during a therapy visit. Patients with recently healed DRF are randomized into two groups, with one group receiving hot packs during therapy and the other immersing the arm in a whirlpool for 3 consecutive therapy visits.

Measurements of wrist and forearm range of motion, and volume of the hand are recorded before and immediately after heat for each visit, effectively creating six measurement time points. Change scores are recorded for range of motion and for volume, and analyzed using MANOVA to determine differences between groups.

Eligibility criteria: Inclusion Criteria:

* Healed DRF,
* allowed to perform motion.

Exclusion Criteria:

* Complex regional pain syndrome,
* inability to read/understand english,
* inability to attend follow up sessions due to driving distance from clinic,
* Raynaud's phenomenon

Primary outcomes:
measure: Change in Wrist Range of Motion (ROM)
timeFrame: Immediately before and within 5 minutes of completing heat application for 3 consecutive weekly therapy visits
Secondary outcomes:
measure: Change in Hand Volume
timeFrame: Immediately before, within 5 minutes of completing heat application, then 30 minutes later for 3 consecutive weekly therapy visits
Other outcomes:
Locations:
city: London
country: Canada
facility: Roth McFarlane Hand & Upper Limb Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Mike Szekeres, PhD (c)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00993005: CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars
Official title: Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Hypertrophic Scars and Keloids Scars.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertrophic Scars
Keloids
Keywords: Hypertrophic scars
Keloids
Asian Gotu Kola
Asian Pennywort
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of Hypertrophic scars and keloids. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons to be recruited and randomized for the study is 90.


Eligibility criteria: Inclusion Criteria:

* Hypertrophic wound or keloid with no treatment for more than 1 month.
* Signed informed consent.

Exclusion Criteria:

* Usage of steroids within 30 days.
* Malignant neoplastic conditions.
* Alcoholism.
* Handicap and/or psychiatric condition preventing treatment accomplishment.

Primary outcomes:
measure: Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)
timeFrame: 12 weeks
Secondary outcomes:
measure: Occurrence of adverse effects at week 12 (end of the treatment)
timeFrame: 12 weeks
measure: Photographs of lesions at week 12 (end of the treatment)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
state: Havana
Study officials:
affiliation: "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
name: Omara Lemus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05587205: Study to Assess Safety and Tolerability of EO2002
Official title: Phase 1, Randomized, Masked, Sham-Controlled Study to Assess the Safety and Tolerability of EO2002 in Subjects Undergoing Cataract Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cataract
Endothelial Cell Loss, Corneal
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
Collaborators: name: Emmecell
First posted: 2022-10-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical study is to assess the safety of intracameral injection of EO2002 in subjects post-cataract surgery.


Eligibility criteria: Key Inclusion Criteria:

1. Age ≥ 18 years.
2. Subject has uncomplicated history of cataract that has progressed to a level requiring standard cataract extraction with intraocular lens implant surgery.
3. Decreased endothelial cell count

Exclusion Criteria:

All ocular criteria apply to study eye unless otherwise noted.

1. Other corneal disease
2. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
3. Descemet membrane detachment.
4. History of uveitis or other ocular inflammatory disease.
5. History of incisional glaucoma surgery
6. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
7. History of ocular neoplasm.
8. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
9. Female who is pregnant, nursing, or planning to become pregnant, or who is of childbearing potential and not using a reliable means of contraception during the study.
10. Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration.
11. Any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator.

Primary outcomes:
measure: Safety and Tolerability of EO2002
timeFrame: 26 weeks
Secondary outcomes:
measure: Endothelial Cell Density
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociacion para Evitar la Ceguera en Mexico
state: Cdmx
Study officials:
affiliation: Asociacion para Evitar la Ceguera
name: Valeria Sanchez Huerta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02295605: Comparison Between Land-based and Water-based Exercises for Knee Osteoarthritis: Randomized Controlled Trial
Official title: Comparison Between a Land-based and Water-based Muscles Strengthening Program on Patients With Knee Osteoarthritis Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Knee Osteoarthritis
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. A blind investigator will assess the patients before and immediately after, 3 months and 6 months following the interventions. The main outcomes will be pain, function and strength.

Detailed description: Forty six patients with knee osteoarthritis will be randomly allocated into two groups: water-based exercises and land-based exercises. Both of them will receive a strengthening exercise protocol for lower limb muscles. A blind investigator will assess the patients before and immediately after, 3 months and 6 months following the interventions. The main outcomes will be pain, function, physical performance and strength.

Eligibility criteria: Inclusion Criteria:

* Moderate knee osteoarthritis (grade 2 or 3 using the Kellgren-Lawrence radiograph classification), diagnosed based on clinical and radiological criteria of the American College of Rheumatology
* No other lower limb and spine musculoskeletal disorders
* Independent gait
* Body mass index below 32
* Minimum of 4 points in the pain numeric rating scale during climb and descend stairs activities

Exclusion Criteria:

* Cognitive or psychological disorders
* Neurological disorders
* History of post-traumatic knee osteoarthritis
* Knee pain at least 12 months
* Prior surgery of the lower limbs or spine
* Fibromyalgia
* Rheumatoid arthritis
* Cardiovascular disease
* Participating in exercise programs and received treatment for the knee at least 3 months

Primary outcomes:
measure: Function
timeFrame: 8 weeks
Secondary outcomes:
measure: Physical Performance
timeFrame: 8 weeks
measure: Strength muscle
timeFrame: 8 weeks
measure: Lower Limbs Function
timeFrame: 8 weeks
measure: Pain
timeFrame: 8 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
state: SP
Study officials:
affiliation: University of Nove de Julho
name: José Geraldo S Morelli, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01912105: Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube
Official title: Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intubation
Expected Duration of Ventilation > 48h
Keywords: endotracheal tube
ct scan
cleaning device
biofilm
mechanical ventilation
Lead sponsor: Azienda Ospedaliera San Gerardo di Monza
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 40
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: Cleaning the endotracheal tube with a specifically designed device results in lower amount of secretions at extubation, assessed by micro CT scan


Eligibility criteria: Inclusion Criteria:

* Patients admitted to an ICU
* 18 years old or more
* expected to be intubated for more than 48 hours
* less than 24 hours from intubation
* fraction of inspired oxygen set at the ventilator \<80%

Exclusion Criteria:

* Current or past participation in another intervention trial conflicting with the present study
* expected survival less than 24 hours
* Acute severe asthma
* Use of Extracorporeal membrane oxygenation (ECMO) or candidates for ECMO
* Double lumen endotracheal tube in place
* Conditions which pose the patient at high risk if inadvertent endotracheal tube displacement occurs (laryngeal edema, cervical spine trauma, upper airways diseases with difficult reintubation)
* other contraindications posed by staff physicians

Primary outcomes:
measure: Volume of secretions
timeFrame: within 12 hours after extubation
Secondary outcomes:
measure: adverse events
timeFrame: until extubation, death or tracheostomy (approximately 2 weeks)
Other outcomes:
measure: endotracheal tube colonization
timeFrame: within 48 hours after extubation
Locations:
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
Study officials:
affiliation: San Gerardo Hospital
name: Antonio Pesenti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Gerardo Hospital
name: Giacomo Bellani, MD PhD
role: STUDY_DIRECTOR
References:
citation: Berra L, Coppadoro A, Bittner EA, Kolobow T, Laquerriere P, Pohlmann JR, Bramati S, Moss J, Pesenti A. A clinical assessment of the Mucus Shaver: a device to keep the endotracheal tube free from secretions. Crit Care Med. 2012 Jan;40(1):119-24. doi: 10.1097/CCM.0b013e31822e9fe3.
citation: Coppadoro A, Bellani G, Bronco A, Lucchini A, Bramati S, Zambelli V, Marcolin R, Pesenti A. The use of a novel cleaning closed suction system reduces the volume of secretions within the endotracheal tube as assessed by micro-computed tomography: a randomized clinical trial. Ann Intensive Care. 2015 Dec;5(1):57. doi: 10.1186/s13613-015-0101-9. Epub 2015 Dec 30.