louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05274386: Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study
Official title: Evaluation of the Impact of SpO2 Averaging Time on Performance of an Automatic FiO2 Control System: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Respiratory Distress
Very Low Birth Weight Infant
Keywords: SpO2 averaging time
pulse oximetry
automatic oxygen control
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
Collaborators: name: Motol University Hospital
First posted: 2022-03-10
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will be switched between 3 averaging times (4to6s-10s-16s) every 12 hours. The sequence will be assigned in random order. Each enrolled subject will continue in the study with regular changes in averaging time through the course of their need for A-FiO2.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to determine the preferred oximeter averaging setting during automated control of FiO2 (A-FiO2) in infants receiving respiratory support and supplemental oxygen.

Detailed description: There are 7 different averaging time settings available with PRICO (Acutronic Medical Systems AG, Hirzel, Switzerland), but after over a year of experience there is no clear clinical impression of the best setting. Therefore, a small systematic study is needed to determine the optimal guidelines.

Eligibility criteria: Inclusion Criteria:

* All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after parental informed consent is obtained.

Exclusion Criteria:

* Parental informed consent is not obtained
* Recording device for automated control of FiO2 is not available

Primary outcomes:
measure: Percent time in SpO2 target range
timeFrame: 20 days of intervention on average
Secondary outcomes:
measure: Effect of set SpO2 target range and mode of ventilation on the percent time in SpO2 target range, at SpO2 <86%, and at SpO2 >98%.
timeFrame: 20 days of intervention on average
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Motol University Hospital
Study officials:
affiliation: Motol University Hospital
name: Jan Janota, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: Thomas E Bachman, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: Veronika Rafl-Huttova, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Czech Technical University in Prague
name: Jakub Rafl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02073786: Rigid Video Stylet Vs Conventional Lightwand Intubation
Official title: : Rigid Video Stylet Can Provide More Successful Intubation Than Conventional Lightwand Intubation in Patients With Cervical Spine Operation : A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hoarseness
Intubation
Sorethroat
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lightwand is a useful alternative device for intubation but scooping movement can induce damage and microbleeding of oral mucosa, postoperative hoarseness,sore throat. Optiscope is rigid video stylet which has camera on distal tip of device. In many previous studies, rigid video stylet has proven advantages compared with other intubating devices.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for cervical spine surgery under general anesthesia
* aged between 20- 80 yrs

Exclusion Criteria:

* Patient who disagrees to participate this study
* Patient who has history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders
* Patient who has congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation or foreign bodies in the upper airway

Primary outcomes:
measure: Primary success rate of intubation
timeFrame: within 90 sec from insertion of device
Secondary outcomes:
measure: Intubation time
timeFrame: within 90 seconds from insertion of device
measure: postoperative complications
timeFrame: During PACU stay time expected up to 1hr
measure: postoperative complications
timeFrame: 24 hr after operation
measure: hemodynamic change
timeFrame: baseline and 1minute after intubation
measure: number of intubation trial and scooping movements
timeFrame: during intubation time, an expected average of 1minute
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University of Hospital
Study officials:
affiliation: Professor
name: Hee Pyung Park, MD PhD
role: STUDY_DIRECTOR
affiliation: fellow
name: Eugene Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00966186: The Rotational Insertion Technique for ProSeal Laryngeal Mask Airway
Official title: The 90-degree Rotational Insertion Technique for the Large Size ProSeal Laryngeal Mask Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Elective Surgery
Keywords: ProSeal Laryngeal Mask Airway
Rotational technique
Success rate
Postoperative complications
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-08-26
Enrollment: 120
Sex: ALL
Minimum age (years): 27
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare two insertion techniques of large size ProSeal laryngeal mask airway. We hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.We compared the success rate and incidence of complication of the standard technique with the rotational technique.

Detailed description: ProSeal laryngeal mask airway is not easy to be inserted due to its larger cuff especially in Asian population. First-time insertion success rate was lower and more time was required to achieve an effective airway even in well-trained physician. A number of techniques have been described to improve the insertion success rate. However, these techniques are only recommended to be used as backup when the digital or introducer tool techniques fail. We hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.We compared the success rate and incidence of complication of the standard technique with the rotational technique.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I-II

Exclusion Criteria:

* Predicted difficult airway
* Mouth opening less than 2.5 cm
* Present sore throat
* High risk of aspiration

Primary outcomes:
measure: Success of Insertion at First Attempt
timeFrame: 5 minute
Secondary outcomes:
measure: Insertion Time, Sealing Pressure and Complication
timeFrame: 5 min - 4 hours
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jung-won Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeon YT, Na HS, Park SH, Oh AY, Park HP, Yun MJ, Kim JH, Hwang JW. Insertion of the ProSeal laryngeal mask airway is more successful with the 90 degrees rotation technique. Can J Anaesth. 2010 Mar;57(3):211-5. doi: 10.1007/s12630-009-9241-4. Epub 2010 Jan 15.
Clinical trial NCT03934086: An Open-label, Intermediate Size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine
Official title: BHV3000-401: An Open-label, Intermediate-size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Migraine
Keywords: Migraine prevention, phonophobia, photophobia, nausea
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-05-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this protocol is to allow subjects who completed any BHV3000 (rimegepant) clinical study to continue to have access to rimegepant while collecting ongoing safety data.

(NOTE: ONLY FOR PATIENTS who participated in a previous BHV-3000/Rimegepant Clinical Trial in the past)


Eligibility criteria: Inclusion Criteria:

1.Subjects who have completed any BHV3000 (rimegepant) clinical study without significant protocol violations.

Exclusion Criteria:

1. History of basilar migraine or hemiplegic migraine
2. History with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease
3. HIV history
4. Uncontrolled hypertension or uncontrolled diabetes
5. Current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
6. History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00602186: Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction
Official title: Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Neurogenic Bladder
Keywords: female voiding dysfunction
Tamsolusin
prazosin
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 80
Sex: FEMALE
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: The purpose of this study is to determine whether Tamsolusin or Prazosin are effective in the treatment of female voiding dysfunction(BOO)

Detailed description: Voiding dysfunction is not uncommon in Tabriz.About 20% of patients in female urology clinic of Tabriz university of medical sciences sufered from some degrees of voiding dysfunction (due to bladder imparement or bladder outlet obstruction).There is limited information about medical treatment of those patients. On the other hand alpha adrenergic blockers are the first choice medication in BENIGN PROSTATIC HYPERPLASIA. There is some new facts about destribution of alpha adrenergic blockers in female pelvic floor.The purpose of this study is to comparision whether Tamsolusin 0.4/daily or Prazosin 1 mg/daily are effective in the treatment of female voiding dysfunction(BOO)

Eligibility criteria: Inclusion Criteria:

* Healthy females with voiding difficulty with MFR\<12 and post void residual urine\>50cc

Exclusion Criteria:

* History of pelvic floor surgury during last 3 month
* Any contraindication for Tamsolusin or prazosin

Primary outcomes:
measure: patient symptoms improvement(Standard questionare)
timeFrame: every month untile 3 months
Secondary outcomes:
measure: Urodynamics parameters improvement
timeFrame: three months later
Other outcomes:
Locations:
Study officials:
affiliation: Urology department ofTabriz University of Medical Sciences
name: SAKINEH hajebrahimi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00126386: Zometa for the Management of Tumor-induced Hypercalcemia and Malignant Bone Pain in the Community
Official title: Zoledronic Acid (Zometa) for the Management of Tumor-induced Hypercalcemia (TIH) and Malignant Bone Pain (MBP) in the Community: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Hypercalcemia
Pain
Keywords: tumor induced hypercalcemia
malignant bone pain
bisphosphonates
cancer
palliative
Zometa
palliative patient
treatment in community
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2005-08-04
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment in the home and hospice of long-term care facilities, particularly for non-ambulatory patients, could provide significant advantages for patients and for the region. The Calgary Health Region has a unique resource in the home parenteral therapy program (HPTP). With the assistance of HPTP, patients requiring bisphosphonate treatment for the management of tumor-induced hypercalcemia (TIH) or malignant bone pain (MBP) could be treated in the community (ie at home). However, the resources required and the costs associated with community-based (homes, hospices, long-term care facilities) treatment of TIH and MBP need to be identified and evaluated so as to guide future regional decision making.

Detailed description: Treatment in the home and hospice of long-term care facilities, particularly for non-ambulatory patients, could provide significant advantages for patients and for the region. The Calgary Health Region has a unique resource in the home parenteral therapy program (HPTP). With the assistance of HPTP, patients requiring bisphosphonate treatment for the management of TIH or MBP could be treated in the community (ie at home). However, the resources required and the costs associated with community-based (homes, hospices, long-term care facilities) treatment of TIH and MBP need to be identified and evaluated so as to guide future regional decision making.

Eligibility criteria: Inclusion Criteria:

If hypercalcemic:

* Serum corrected Ca+++\>= 2.5 mmol/L and symptomatic hypercalcemia
* Asymptomatic hypercalcemia with corrected Ca+++\>= 3.0 mmol/L
* Moderate to severe intolerable pain (\>=6/10 on numerical rating scale \[NRS\]) despite optimal treatments with a strong opioid such as morphine, hydromorphone, fentanyl, oxycodone or methadone
* Radiotherapy bone pain related to metastatic bone disease

Exclusion Criteria:

* Not on a regular bisphosphonate regimen

Primary outcomes:
measure: feasibility of treating hypercalcemia in the community
measure: resources required
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: Alberta Cancerboard
name: Jose Pereira, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00882986: Cardiovascular and Metabolic Responses to a Mixed Meal
Official title: Role of Exercise Training and Body Weight on Cardiovascular and Metabolic Responses to a Mixed Meal Tolerance Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Keywords: insulin resistance
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2009-04-17
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young, lean, healthy men

Brief summary: The purpose is to determine whether regular endurance exercise and/or body weight influence the way our nervous and vascular systems respond during the metabolism of meals.

Detailed description: To begin to examine this question we recruited healthy endurance-trained (high fit, HF) and normally active (average fit, AF) subjects. It is well characterized that chronic endurance training results in enhanced peripheral insulin sensitivity. Therefore, our rationale was that inclusion of two healthy subject groups, with distinct differences in insulin sensitivity, would allow us to investigate how enhanced insulin sensitivity influences insulin-mediated changes in central sympathetic outflow. Direct measurements of central sympathetic outflow to skeletal muscle (i.e., MSNA) were recorded, and a mixed meal was used as a physiological method to evoke robust and sustained increases in MSNA, which have been primarily attributed to insulin. We hypothesized that HF subjects would have a greater MSNA response, for a given plasma insulin concentration, following consumption of a mixed meal (i.e., greater central insulin sensitivity).

Eligibility criteria: Inclusion Criteria:

* healthy, not currently taking any medications

Exclusion Criteria:

* unhealthy, taking medications

Primary outcomes:
measure: insulin/glucose response to mixed meal ingestion
timeFrame: This study is cross-sectional. Primary and secondary measures will be assessed at a single timepoint.
Secondary outcomes:
measure: MSNA
timeFrame: This is a cross-sectional study. Primary and seconardy measures will be assessed at a single visit lasting 4-6 hours.
measure: Blood flow
timeFrame: This is a cross-sectional study. Primary and seconardy measures will be assessed at a single visit lasting 4-6 hours.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: John P Thyfault, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02333786: Ultrasound-guided Arterial Catheterization in Pediatric Patients
Official title: Comparison of Long-axis/In-plane and Short-axis/Out-of-plane Methods During the Ultrasound-guided Arterial Cannulation in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound
Arterial Catheterization
Child
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 108
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Investigators designed a prospective randomized controlled study to compare the long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial catheterization in pediatric patients younger than 5 years old.


Eligibility criteria: Inclusion Criteria:

* Surgery under general anesthesia
* Requires invasive arterial blood pressure monitoring

Exclusion Criteria:

* Infection/hematoma/skin disease/arteriovenous fistula/recent catheterization scar in radial artery or posterior tibial artery
* Peripheral vascular disease
* Congenital aortic disease

Primary outcomes:
measure: Arterial catheterization time
timeFrame: Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average of 200 seconds
Secondary outcomes:
measure: Ultrasound imaging time
timeFrame: Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, an expected average of 30 seconds
measure: Time to first puncture of the artery
timeFrame: Interval between skin penetration of the needle and flashback of blood, an expected average of 100 seconds
measure: Number of puncture attempts
timeFrame: Up to 5 times, an expected average observation time of 600 seconds
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song IK, Choi JY, Lee JH, Kim EH, Kim HJ, Kim HS, Kim JT. Short-axis/out-of-plane or long-axis/in-plane ultrasound-guided arterial cannulation in children: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):522-7. doi: 10.1097/EJA.0000000000000453.
Clinical trial NCT06237686: Clinical Investigation Exploring Two Ostomy Product Prototypes
Official title: Clinical Investigation Exploring Two Ostomy Product Prototypes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Two ostomy product prototypes (Test product A and B) will be tested in this investigation.

All subjects will test both Test product A and B, with a minimum of 7 days apart. In total, each subject will be enrolled in the investigation for 8 days +3 days.


Eligibility criteria: Inclusion Criteria:

1. Has given written informed consent
2. Is at least 18 years of age and has full legal capacity
3. Has had an ileostomy for more than 3 months
4. Has suitable peristomal skin area (assessed by investigator)
5. Is currently using flat SenSura Mio 1-piece or 2-piece
6. Has used flat SenSura Mio 1-piece or 2-piece for at least 14 days
7. Has a stoma size less than 45mm in diameter

Exclusion Criteria:

1. Is currently receiving or have within the past 60 days received radio- and/or chemotherapy (Low doses radio- and/or chemotherapy (Assessed by Principal Investigator) is allowed. for indications other than cancer)
2. Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g. lotion or spray or systemic steroid (tablet/injection) treatment
3. Is pregnant or breastfeeding
4. Has dermatological problems in the peristomal area (assessed by investigator)
5. Participates in other clinical investigations. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol
6. Has any known allergies towards ingredients in the investigational device

Primary outcomes:
measure: Primary objective
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
References: