louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03853889: Evaluation of the Effect on Optic Nerve Sheath Diameter in Patients Undergoing Cesarean Section
Official title: Evaluation of the Effect of Epidural Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Pressure
Keywords: optic nerve sheath pressure
noninvasive intracranial pressure measurement
epidural anesthesia
cesarean
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: Depending on the physiology of pregnancy, the risk of increased aspiration, difficult airway, increased oxygen consumption and reduced functional residual capacity, breathing problems make general anesthesia application risky. In obstetric operations, neuraxial anesthesia is preferred because of both maternal and maternal mortality and morbidity. Epidural area has decreased due to pregnancy physiology. Previous studies have shown that the blood given to the epidural area increases the intracranial pressure by compressing the dura mater.Optic nerve diameter measurements ultrasound guided is a non-invasive and reliable method for detecting intracranial pressure increase.

In this study, aimed to compare the optic nerve sheath diameter before and after epidural anesthesia with USG.

Detailed description: Epidural anesthesia will be performed at L2 level and sitting position in all patients. Patients will be measured and recorded for optic nerve sheath diameter at 15 min (T2), 30 min (T3) and 60 min (T4) immediately after epidural anesthesia (T0) and after epidural anesthesia.. Measurement of the optic nerve sheath diameter will be done with the help of a linear probe without applying high pressure to the eyeball while the patient is in supine position and the eyelids are closed. The optic nerve sheath diameter will be measured 3 mm beyond the optical disc. The measurements shall be applied in both transverse and sagittal planes for both eyes and the arithmetic mean of the four measured values.

Eligibility criteria: Inclusion Criteria:

* epidural anesthesia patients
* 18-40 years patients
* American Society of Anesthesiologists status I-II patients

Exclusion Criteria:

* Patients with allergy to any of the drugs to be used in the study,
* patients with severe heart failure,
* atrial and ventricular arrhythmias,
* severe valve disease,
* electrolyte disorder,
* renal failure, preeclampsia, eclampsia

Primary outcomes:
measure: increase in the diameter of the optic nerve sheath after epidural anesthesia
timeFrame: Basal(T0),Immediately after administration of epidural anesthesia(T1), after epidural anesthesia 15 min(T2), 30 min (T3),60 min (T4)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bolu Abant İzzet Baysal University
name: murat bilgi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03172689: Validation of CardioQ Versus PiCCO in Children
Official title: Validation of an Ultrasound Oesophageal Doppler Cardiac Output Monitor (ODM+, CardioQ) Versus a Transpulmonary Thermodilution Cardiac Output Monitor (TPTD, PiCCO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Output
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 17
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: children with an clinical indication for cardiac output monitoring in ICU or OR
Primary purpose: DIAGNOSTIC

Brief summary: To compare the less invasive Oesophageal Doppler cardiac output Monitor (ODM) to the invasive (standard of care) Transpulmonary Thermodilution cardiac output monitor (TPTD) in children.

Detailed description: This is a validation study. The study period starts as soon as CMO approval is acquired and will end after inclusion of 17 patients. This study is designed to test the effectiveness of a non invasive ODM catheter compared to the invasive, gold standard, TPTD technique.

Eligibility criteria: Inclusion Criteria:

* Patients aged 0 to 16 years with an indication for invasive CO monitoring (TPTD). Indication for invasive CO monitoring always implies intubation and sedation.
* Signed informed consent

Exclusion Criteria:

* Congenital or acquired cardiovascular diseases (intracardiac/extracardiac intrathoracic shunt
* Cardiac valve diseases
* Aortic arch anomalies
* Tissue necrosis of oesophagus
* Carcinoma of pharynx, larynx of oesophagus
* Severe bleeding diatheses
* Age \> 16 years
* Weight \< 3.5 kg or \> 50 kg.

Primary outcomes:
measure: cardiac output
timeFrame: 24 hours
measure: stroke volume
timeFrame: 24 hours
Secondary outcomes:
measure: flow time corrected
timeFrame: 24 hours
measure: stroke distance
timeFrame: 24 hours
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud Univeristy Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Gert Jan Scheffer, prof. dr
role: STUDY_CHAIR
References:
Clinical trial NCT02578589: Medial Plica Syndrome of the Knee: Conservative Treatment Versus Arthroscopic Plica Resection - a Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plica Mediopatellaris
Lead sponsor: Regionshospitalet Silkeborg
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 72
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 purpose of this trial is to evaluate the effect of conservative treatment in comparison to arthroscopic resection of pathological medial plicae of the knee for patients with medial plica syndrome. The investigators expect conservative treatment to be significantly superior to arthroscopic plica resection with regard to symptom remission and return to prior functional level.


Eligibility criteria: Inclusion Criteria:

* Aged over 18 years
* History of antermedial knee pain
* Palpable medial band in clinical examination or medial plica appearence on MRI
* Absence of all of the following diagnoses: Osteoarthritis, osteochondritis dissecans, meniscal injury, patella subluxation, pes anserinus bursit, patellofemoral pain syndrome
* Given declaration of consent
* Joining a fitness centre for the duration of minimum 3 months at their own expense.

Exclusion Criteria:

Aged under 18 years

* Presence of one or more of the following diagnoses: Osteoarthritis, osteochondritis dissecans, meniscal injury, patella subluxation, pes anserinus bursit, patellofemoral pain syndrome
* Prior surgical intervention, infection, fracture or patellar luxation concerning the relevant knee
* Not willing to join a fitness centre for the duration of minimum 3 months at their own expense

Primary outcomes:
measure: Lysholm-Scale (Units on a scale)
timeFrame: 2 years
Secondary outcomes:
measure: Kujala-Scale (Units on a scale)
timeFrame: 2 years
measure: QOL-Scale (Units on a scale)
timeFrame: 2 years
measure: VAS-Scale (Visual Analog Scale for pain) (Units on a scale)
timeFrame: 2 years
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Regionshospital Silkeborg
city: Silkeborg
country: Denmark
facility: Regionshospitalet Silkeborg
Study officials:
References:
Clinical trial NCT06972589: The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
Official title: The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Obesity Hypoventilation Syndrome (OHS)
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2025-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV) delivers positive pressures via an interface such as a face mask and has been shown to improve breathing and reduce symptoms in patients with these conditions. Regular use of NIV can lead to better symptom management, improved quality of life, and reduced use of healthcare resources. However, poor performance of the NIV mask and poor comfort can make NIV therapy harder to tolerate. This study will assess if a new mask helps to improve the breathing of people on NIV and normalize blood gases.

Detailed description: Participants are moved to the sleep laboratory for the night where they are provided with beds.

* The participants are put on their prescribed airway pressure support with the first randomized mask.
* After at least 60 minutes of recording, participants are awakened to switch back to the second mask. They are then allowed to sleep uninterrupted for the rest of the night.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Prescribed nocturnal NIV for COPD or OHS
* Able to complete an overnight sleep study
* Comfortable to sleep on a standard double bed
* Capacity to complete informed consent

Exclusion Criteria:

* Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events/hour off personal NIV device data)
* Prescribed IPAP above 25 cmH2O
* Allergic to adhesive of the sensors
* Self-reported cold/flu symptoms

Primary outcomes:
measure: Change in respiratory rate
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher and Paykel Healthcare Sleep Laboratory
Study officials:
affiliation: Middlemore Hospital, New Zealand
name: William Good, Medical degree
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01127789: The Use of Transcranial Direct Current Stimulation (tDCS) to Study Implicit Motor Learning on Patients With Brain Injury
Official title: The Use of Transcranial Direct Current Stimulation (tDCS) to Study Implicit Motor Learning on Patients With Brain Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Traumatic Brain Injury
Stroke
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study motor learning and recovery of patients with brain damage caused by traumatic brain injury or stroke with transcranial direct current stimulation (tDCS). It is hypothesized that anodal tDCS on the lesion side and/or cathodal tDCS on the healthy side of motor cortex could improve the recovery of motor function such as learning.

Detailed description: We aim to apply transcranial direct current stimulation (tDCS) to study the recovery process of motor learning on the patients with brain damage caused by traumatic brain injury or stroke. Both anodal and cathodal tDCS will be used to test whether the increase of motor cortical activity by anodal tDCS over lesional side or the decrease of brain activity by cathodal tDCS on healthy side will improve the learning skill (SRTT: serial reaction time task). The result could help to understand the mechanism of motor and cognitive recovery after brain damage, and further rationalize the application of non-invasive brain stimulation such as tDCS for patient rehabilitation.

Eligibility criteria: Inclusion Criteria:

* TBI or stroke patients
* with partially preserved fine motor function

Exclusion Criteria:

* with metal clips in head or device (e.g. pacemaker)
* with active CNS drugs

Primary outcomes:
measure: Reaction time (millisecond)
timeFrame: 24 hours post intervention
Secondary outcomes:
measure: Error rate (percentage)
timeFrame: 24 hours post intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Dpt. Physical Medicine and Rehabilitation, NTUH
Study officials:
affiliation: Dpt. Physical Medicine and Rehabilitation, NTUH Taipei, Taiwan
name: Wen-Shiang Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Clinical trial NCT01984489: Efficacy and Safety Study of SHR117887 in Combination With Metformin in Patients With Type 2 Diabetes
Official title: A Multicenter Randomized, Double-blind, Placebo Controlled ,Parallel Group ,Phase II Study to Access the Efficacy and Safety of SHR117887 in Combination Therapy With Metformin in Patients With Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: SHR117887, Metformin,combination,PhaseII
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-14
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: SHR117887 is a new dipeptidyl peptidase(DPP)-4 inhibitor. This study aims to evaluate the efficacy and safety of SHR117887 in combination therapy with Metformin in patients with Type 2 Diabetes in Metformin monotherapy Who have Inadequate Glycemic Control


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with type 2 diabetes mellitus
* Patients have been treated with metformin for at least 8 weeks and be on a stable dose of at least 1500mg daily prior to the screening visit
* HbA1C：≥7.5% and ≤11.0% at screeing visit and at the end of run-in period
* Age:≥20 and ≤70 years
* BMI(body mass index):≥20 and ≤35 kg/m2

Exclusion Criteria:

-

Primary outcomes:
measure: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving Less Than (<) 6.5% or <7% HbA1c Levels
timeFrame: 12 weeks
measure: Change From Baseline in Fasting Plasma Glucose,insulin and C-peptide at Week 12
timeFrame: 12 weeks
measure: Post-meal total and incremental glucose,insulin and C-peptide area under the curve at week 12
timeFrame: 12 weeks
measure: Change From Baseline in Body Weight at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03608189: Multimodal Assessment of Knee Conditions in Rehabilitation
Official title: Multimodal Assessment of Knee Conditions in Rehabilitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ACL Injury
Keywords: Osteoarthritis
ACL injury
Knee trauma
Meniscus tear
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient participating in rehabilitation due to ACL injuries and potential other knee disorders.

Brief summary: The purpose of this study is to assess ACL injury and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint.


Eligibility criteria: Inclusion Criteria:

* ACL injury
* Ages 18-40
* Female

Exclusion Criteria:

* BMI under 18
* BMI over 40
* Contraindications to MRI

Primary outcomes:
measure: Objective evaluation method for knee disorder recovery
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University of Oulu
state: Pohjois Pohjanmaa
Study officials:
affiliation: University of Oulu
name: Simo Saarakkala, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Osmo Tervonen, Ph.D., M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01801189: Preoperative Pain Control in Gastric Bypass Surgery Patients
Official title: A Randomized Placebo-Controlled Study of Whether Pre-operative Pregabalin 300 mg Will Improve Pain Control in Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass (Bariatric Surgery)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Pain
Lead sponsor: Legacy Health System
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly obese patients undergoing laparoscopic gastric bypass surgery.

Detailed description: Pregabalin is a popular adjunct for relieving neuropathic pain in diabetics. There have been multiple studies evaluating its use in pre and post-operative pain control in various surgeries. Post-operative pain control is a challenging problem in bariatric patients due to the high doses of narcotic required, related to the high body mass, and the danger of concomitant respiratory depression. In the obese patient, the goal of postoperative pain management is provision of comfort, early mobilization and improved respiratory function, without causing inadequate pain control, respiratory compromise or increased nausea.

Methods: A Randomized Controlled Trial, whereby patients undergoing Laparoscopic Roux-en-Y gastric bypass will be administered a single pre-operative dose of Pregabalin or a placebo. We plan to follow their immediate post-operative course in the hospital, with regard to the following primary endpoints:

* Post-operative analgesic requirements
* Post-operative pain scale (rated 0-10)
* Episodes of vomiting
* Post-operative antiemetic requirement
* Length of stay

Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery.

Exclusion Criteria:

-

Primary outcomes:
measure: Post-operative Pain Medication Requirements
timeFrame: Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2.
Secondary outcomes:
measure: Length of Stay
timeFrame: Days in hospital following surgical procedure, up to 5 days
Other outcomes:
Locations:
city: Portland
country: United States
facility: Legacy Good Samaritan Medical Center
state: Oregon
Study officials:
affiliation: Legacy Health System
name: Valerie Halpin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01697189: An Educational Intervention to Promote Safe Driving
Official title: An Educational Intervention to Promote Safe and Economic Truck Driving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Driver Sleepiness
Keywords: professional drivers
sleepiness
stress
safe driving
training
Lead sponsor: Finnish Institute of Occupational Health
Sponsor class: OTHER
Collaborators: name: University of Jyvaskyla
name: Tampere University of Technology
name: Taipale Telematics Ltd
First posted: 2012-10-02
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The general aim of the study is to promote safe, economic, and environmental-friendly driving among long-haul truck drivers. To do this, the investigators will conduct an on-road study on i) the relationship of driver sleepiness and stress with driving behaviour and fuel consumption and ii) effectiveness of an educational intervention in mitigating sleepiness at the wheel. The educational intervention is designed to be employed by occupational health care professionals in the future. This solution clearly facilitates the implementation of the intervention into practice if it turns out to be effective.

The investigators specified research questions are the following:

* Do truck driver sleepiness and stress at the wheel reach levels that affect driving behaviour, fuel consumption and carbon emissions?
* What are the sources of sub-optimal arousal at the wheel in truck drivers?
* Can truck driver sleepiness be mitigated by an educational intervention, and if yes, does it improve driving behaviour and decrease fuel consumption and carbon emissions as well?


Eligibility criteria: Inclusion Criteria:

* working as a truck driver at the moment of the study
* having both day and night trips
* having at least 2 years of experience in truck driving

Exclusion Criteria:

* not fluent in Finnish (the intervention is in Finnish)

Primary outcomes:
measure: driver sleepiness
timeFrame: one year
Secondary outcomes:
measure: driver stress
timeFrame: one year
measure: sleep
timeFrame: one year
measure: driving behaviour
timeFrame: one year
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Finnish Institute of Occupational Health
Study officials:
affiliation: Finnish Institute of Occupational Health
name: Mikael Sallinen, PhD
role: PRINCIPAL_INVESTIGATOR
References: