louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04072328: Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam
Official title: Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sedation
Endoscopy
Keywords: Midazolam
Propofol
Sedation
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is to compare propofol vs. midazolam with propofol for sedative endoscopy in patients with previous paradoxical reaction to midazolam. Patients who meet eligibility criteria will randomly assigned to propofol group or midazolam with propofol group. Then they will receive a sedative endoscopy with close monitoring. The primary outcome is the prevalence of paradoxical response during endoscopy.


Eligibility criteria: Inclusion Criteria:

* History of midazolam-induced paradoxical response

Exclusion Criteria:

* Failed to obtain informed consent
* Pregnant or breast feeding women
* A severe cardiopulmonary or vascular disease with symptoms
* Cognitive or mental impairment

Primary outcomes:
measure: The prevalence of paradoxical response
timeFrame: At the end of endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyeonggi-do
Study officials:
References:
citation: Lee TH, Lee CK, Park SH, Lee SH, Chung IK, Choi HJ, Cha SW, Moon JH, Cho YD, Hwangbo Y, Kim SJ. Balanced propofol sedation versus propofol monosedation in therapeutic pancreaticobiliary endoscopic procedures. Dig Dis Sci. 2012 Aug;57(8):2113-21. doi: 10.1007/s10620-012-2234-0. Epub 2012 May 22.
citation: Tae CH, Kang KJ, Min BH, Ahn JH, Kim S, Lee JH, Rhee PL, Kim JJ. Paradoxical reaction to midazolam in patients undergoing endoscopy under sedation: Incidence, risk factors and the effect of flumazenil. Dig Liver Dis. 2014 Aug;46(8):710-5. doi: 10.1016/j.dld.2014.04.007. Epub 2014 Jun 2.
citation: Mancuso CE, Tanzi MG, Gabay M. Paradoxical reactions to benzodiazepines: literature review and treatment options. Pharmacotherapy. 2004 Sep;24(9):1177-85. doi: 10.1592/phco.24.13.1177.38089.
Clinical trial NCT01818128: The Pretreatment of a Left-sided Double-lumen Tube to Prevent Its Misplacement to the Right Mainstem Bronchus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Double Lumen Tube Intubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 1540
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate whether flexion of bronchial tip of a left-sided double lumen endobronchial tube prevents tube misplacement to the right mainstem bronchus.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion Criteria:

* Abnormal anatomy of tracheobronchial tree
* Intraluminal lesion in the left or right mainstem bronchus
* Anticipated difficult intubation

Primary outcomes:
measure: Number of participants with intubation to right mainstem bronchus
timeFrame: An expected average of 5minutes after intubation
Secondary outcomes:
measure: Number of participants with airway injury
timeFrame: An expected average of 5 minutes after bilateral lung ventilation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02691728: Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease
Official title: A Phase 4, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis C
Lead sponsor: Peter J. Ruane, M.D., Inc.
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2016-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is evaluating the safety and efficacy of a 12 week treatment LDV/SOF FDC in patients with Chronic GT1 or GT4 HCV infection and autoimmune disease


Eligibility criteria: Inclusion Criteria:

* Chronic GT1 or GT4 HCV Infection
* Diagnosed with autoimmune disease (rheumatoid arthritis, psoriatic arthritis, lupus, etc.) and is currently receiving treatment for the condition.

Exclusion Criteria:

* Infection with HIV or HBV

Primary outcomes:
measure: SVR12 (Sustained Virologic Response)
timeFrame: Sustained Virologic Response 12 Weeks after Treatment Completion
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Peter J. Ruane, MD, Inc.
state: California
Study officials:
References:
Clinical trial NCT03756428: Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle
Official title: Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle: Baropodometric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Movement Disorders
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to analyze the changes in plantar support after the technique of deep dry puncture in the posterior tibial. The data will be analyzed by a baropodometer which will record the possible changes in the footprint. The investigator will perform a pre-intervention measurement and 3 post-intervention measurements (immediately after the intervention, at 24 hours and at 72 hours)


Eligibility criteria: Inclusion Criteria:

* presence of myofascial trigger point in the posterior tibialis
* Accept participation in the study (signature of informed consent)
* Do not present any exclusion criteria

Exclusion Criteria:

* Do not present myofascial trigger point in the tibialis posterior.
* Suffering and / or having suffered from lower limb pathologies, deformities or orthopedic injuries that could alter the static and biomechanics.
* Not clearly identify the Myofascial trigger point in the tibialis posterior.
* Have been diagnosed with fibromyalgia, myelopathy or radiculopathy.
* Having contraindicated the technique of dry needling for suffering, for example, coagulation problems.
* Be pregnant.
* Have used analgesics 24 hours before participating in the study.

Primary outcomes:
measure: Pain pressure threshold
timeFrame: 72 hours
Secondary outcomes:
measure: baropodometric measurements: footprint
timeFrame: 72 hours
measure: baropodometric measurements: Average footprint pressure
timeFrame: 72 hours
measure: baropodometric measurements: forefoot area
timeFrame: 72 hours
measure: baropodometric measurements:forefoot load
timeFrame: 72 hours
measure: baropodometric measurements: forefoot pressure variation
timeFrame: 72 hours
measure: baropodometric measurements: rearfoot support surface
timeFrame: 72 hours
measure: baropodometric measurements: hindfoot load
timeFrame: 72 hours
measure: baropodometric measurements: areas of maximum pressure between the foot lines
timeFrame: 72 hours
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universidad CEU Cardenal Herrera
state: Moncada
Study officials:
References:
Clinical trial NCT00862628: The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID) - Induced Small-intestinal Injuries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NSAIDs-induced Small-intestinal Injuries
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2009-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
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 evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* 20 to 85 years of age
* RA, OA, or low back pain
* No change of drugs before 3 months
* Under 5 mg of corticosteroid use
* CRP \< 1mg/dl
* Small-intestinal mucosal injuries more than one
* Hemoglobin level is below normal range

Exclusion Criteria:

* Known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis
* Prostaglandins, metronidazole or salazosulfapyridine
* Can not swallow
* Eith pacemaker
* After gastrointestinal operation
* Serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease.
* Taking rebamipide before one week
* Any other conditions that the investigator feels would interfere with data interpretation or create under risk.

Primary outcomes:
measure: The number of mucosal breaks
timeFrame: 4 and 8 weeks after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Department of Gastroenterology, Nagoya University Graduate School of Medicine
state: Aichi Prefecture
city: Nagoya
country: Japan
facility: Department of Gastroenterology, Nagoya University Graduate School of Medicine
state: Aichi Prefecture
Study officials:
affiliation: Nagoya University Hospital
name: Naoki Ohmiya, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01151228: Bedside Ultrasound Assessment of Gastric Content and Volume
Official title: Bedside Ultrasound Assessment of Gastric Content and Volume. Validating a Mathematical Model Using Gastroscopic Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroscopy
Keywords: gastroscopy
ultrasound
stomach volume
patients having gastroscopy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-06-28
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Patients undergoing gastroscopy will undergo two pre-procedure ultrasound scans of the stomach, once on arrival in the unit and on an empty stomach and a second time after consumption of a randomized amount of apple juice (0, 50, 100, 200, 300 or 400 mL). Immediately after ingestion and the second ultrasound scan, subjects will have their gastroscopy which will start by suctioning out the apple juice. Measurements of stomach fluid volume conducted by ultrasound will be compared to the actual volume removed during the gastroscopy procedure.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Weight 50-100 kg
* height greater than 150 cm
* ability to provide informed consent

Exclusion Criteria:

* recent upper GI bleed (within 1 month)
* previous lower esophageal or gastric surgery
* not fasted for 8 hours

Primary outcomes:
measure: Stomach volume
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Anahi Perlas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04094428: Burden, Mortality and Supply Costs in Intensive Care Unit Patients
Official title: Burden, Mortality and Supply Costs in Intensive Care Unit Patients. Health Services Research.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Burden, Dependency
Mortality
End-of-life Care
Intensive Care Unit
Critically Ill Patient
Frailty
Multiple Organ Failure
Keywords: burden
mortality
end-of-life care
intensive care unit
critically ill patient
frailty
Multiple Organ Failure
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to the intensive care unit, mainly surgical and polytraumatized patients

Brief summary: This study systematically observes in a pragmatic trail under real world conditions the association between strategies of therapy (maximal therapy, withhold, withdraw) and treatment success in three endpoint related initial risk groups (high, intermediate, low risk) regarding three endpoints (burden, mortality and supply costs).

Detailed description: This study systematically observes in a pragmatic trail under real world conditions the association between strategies of therapy (maximal therapy, withhold, withdraw) and treatment success in three endpoint related initial risk groups (high, intermediate, low risk) regarding three endpoints (burden, mortality and supply costs).

The 3 endpoints and 3 respective risk groups (high, intermediate, low) are

1. Endpoint burden of care due to Clinical Frailty Scale (Frailty) high 7 - 9 intermediate 5 - 6 low 1 - 4
2. Endpoint mortality due to severity of disease regarding Simplified Acute Physiology Score (SAPS) II score values high SAPS II \> 70, suspected mortality \> 40% intermediate SAPS II \> 40 - 70, suspected mortality 10 - 40% low SAPS II ≤ 40, suspected mortality \< 10%
3. Endpoint supply costs due to number of organ systems to be supported or replaced high ≥ 3 organ systems replaced intermediate 1 - 2 organ systems replaced low 0 - 2 organ systems replaced

Eligibility criteria: Inclusion Criteria:

* All patients dying on the ICU and all patients staying for at least 72 hours on the ICU

Exclusion Criteria:

* No

Primary outcomes:
measure: Burden of care
timeFrame: 18 months
measure: Mortality
timeFrame: 18 months
measure: Supply costs
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Department of Anaesthesiology, University Hospital Ulm
Study officials:
affiliation: University Hospital Medical School
name: Manfred Weiss, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05417828: Robotic Rehabilitation for Stroke Survivors
Official title: Robotic Rehabilitation for Stroke Survivors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Stroke
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Department of Neurology Jacobs School of Medicine and Biomedical Sciences University at Buffalo.
First posted: 2022-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study participant needs to have minimal strength to move the robot. The participant needs to be able to understand the instructions during the experiment.

Brief summary: Pilot study on the physiological response of robotic rehabilitation therapy for improving the performance of activities of daily living of stroke patients

Detailed description: The purpose of this research is to study the feasibility of the robotic therapy that can train activities of daily living tasks for chronic stroke patients. The participant will be involved in a feasibility study (one-time visit) to prove the efficacy of the robotic device with different force feedback (assistive and resistive force) and other feedback such as VR (virtual reality). We will collect movement data from a motion capture system and sEMG sensors that measure muscle activity to monitor the effect of a robotic rehabilitation device, named Spherical Parallel Instrument for Daily Living Emulation (SPINDLE). We will use a robotic therapy device to practice activities during daily living. This pilot study will be used to understand the effect of SPINDLE to translate the device as a home-based training for chronic stroke patients.

Eligibility criteria: Inclusion Criteria:

* Adults with chronic stroke, which affected their upper limb motor functions
* Adults could able to understand the verbal cues during the training

Exclusion Criteria:

* Adults with chronic stroke, who did not lose their upper limb motor functions

Primary outcomes:
measure: Kinematic change of the upper limb during ADLs
timeFrame: immediately after the intervention
measure: Score of activities of daily living(ADL) tasks
timeFrame: immediately after the intervention
measure: Muscle activation change of the upper limb during ADLs
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Usability measure
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, North Campus, Furnas 809
state: New York
Study officials:
affiliation: University at Buffalo
name: Jiyeon Kang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06817928: Investigating the Performance and Safety of the AudioKey 3, a Device That Provides Remote Control Options and Status Information for Compatible MED-EL Audio Processors, by Analyzing Data Logged by the App and Responses to a User Survey
Official title: Evaluation of the AudioKey 3 App
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cochlear Implants
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MED-EL CI and audio processor users MED-EL AudioKey 3 users

Brief summary: Investigating the performance and safety of the AudioKey 3, a device that provides remote control options and status information for compatible MED-EL audio processors, by analyzing data logged by the app and responses to a user survey.


Eligibility criteria: Inclusion Criteria:

* MED-EL CI and audio processor users
* MED-EL AudioKey 3 users

Exclusion Criteria:

* Lack of compliance with any inclusion criteria

Primary outcomes:
measure: The primary objective of this clinical investigation is to confirm the performance of the AudioKey 3 app as assessed by a user survey
timeFrame: At time of device use
Secondary outcomes:
measure: App user ratings obtained via user survey
timeFrame: At time of device use
measure: App usage time obtained from data logging information
timeFrame: up to 12 months
measure: Audio processor use obtained from data logging information
timeFrame: up to 12 months
measure: • Type of implants, audio processors, auditory scenes (e.g. speech in quiet or noise) obtained from data logging information
timeFrame: up to 12 months
measure: Device-related complications collected via user survey
timeFrame: At time of device use
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: MED-EL Elektromedizinische Geräte GmbH
Study officials:
References:
Clinical trial NCT03414528: Identification of New Inborn Errors of Immunity
Official title: Towards Identification of New Inborn Errors of Immunity by Whole Exome/Genome Sequencing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Immune Deficiency Disorder
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unidentified inborn error of immunity (primary immunodeficiency, PID) or optionally healthy direct relatives, to determine whether they are carriers of the disease

Brief summary: Analysis of DNA samples of patients with molecularly undetermined PID by whole exome/genome sequencing.

Transcriptome analysis of patients with molecularly undetermined PID.


Eligibility criteria: Inclusion Criteria:

* Patients with primary immunodeficiency (PID)
* Male and Female participants 0 years to adult age (any)
* Written informed consent by the participant after information about the research project

Exclusion Criteria:

* Secondary immunodeficiency
* Refusal to enter the study

Primary outcomes:
measure: Identification of the genetic defects
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Janine Reichenbach, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: