louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03125031: Comparison of Noninvasive Hemoglobin Disposable Sensors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the concentration of hemoglobin within the subject's blood will be reduced in a controlled manner by administering fluids intravenously. The accuracy of two noninvasive hemoglobin sensors will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 18-40 years of age
* Weight of at least 110 lbs and less than 250 lbs for subjects under 6 feet tall.
* Physical status of ASA I of II
* Able to read and communicate in English
* Has signed written informed consent
* Female, non pregnant.

Exclusion Criteria:

* Age less than 18 yrs and greater than 40 years
* If the Warming and cooling subjects have open cuts of skin abrasions on their extremities they will be excluded because alcohol spray may be painful.
* Weight of less than 110 lbs or more than 250 lbs if the subject is less than 6 feet tall.
* Hemoglobin less than 11 g/dL
* ASA physical status of III. IV, V.
* Pregnant
* Subject has known drug or alcohol abuse
* Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails.
* Subject has experienced a head injury with loss of consciousness within the last year.
* Subject has known neurological and psychiatric disorder that interferes with the subjects' level of consciousness.
* Known or concurrent chronic usage of psychoactive or anticonvulsive drugs within the last 90 days, or any use in the last 7 day (i.e. tricyclic antidepressants, MAO inhibitors, Lithum, neuroleptics, anxiolytics or antipsychotics, except SSRIs).
* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study, such as Reynauds Syndrome.
* Systolic BP \>140 mmHg or Diastolic BP \> 100 mmHg.
* Baseline heart rate \< 50 bpm.
* Inability to tolerate sitting still or minimal movement for up to 90 minutes
* Discretion of investigator

Primary outcomes:
measure: Accuracy of Noninvasive Sensors by Arms Calculation
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
Study officials:
References:
Clinical trial NCT04691531: Decreasing the Invasiveness of Ultrasound Guided Caudal Block: A Comparison Between 22-gauge and 27-guage Needles
Official title: Decreasing the Invasiveness of Ultrasound Guided Caudal Block: A Randomized Controlled Trial Comparing Between 22-gauge and 27-guage Needles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Pain
Caudal Block
Pediatric Anesthesia
Abdominal Surgeries
Keywords: Caudal block
Ultrasound
Pediatric anesthesia
Pain
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ultrasound (US) has facilitated the use of caudal block in children and visualization of the needle during insertion. This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.

Detailed description: Ultrasound (US) has facilitated the use of caudal block in children, allowing an initial assessment of the anatomy of the sacrum, including the relationship of the sacral hiatus to the dural sac ending. Real-time US allows visualization of the needle during insertion to reach the dural sac, and to see the turbulence and distention of the layers during injection of the local anesthetic drug.

This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.

Eligibility criteria: Inclusion Criteria:

* Age between 6 months and 36 months
* Undergoing elective lower abdominal or perineal surgeries

Exclusion Criteria:

* Refusal of the legal guardian of the patient.
* Patients aging less than 6 months, or older than 36 months.
* Emergency surgeries.
* Coagulopathy.
* infection at the site of procedure.
* Uncorrected hypovolemia.
* Increased intracranial pressure.
* Congenital anomalies at the site of procedure.

Primary outcomes:
measure: Opioids requirements intraoperatively
timeFrame: 90 minutes
measure: Pain score in the post-anesthesia care unit (PACU)
timeFrame: 120 minutes
measure: Peri-operative complications
timeFrame: 210 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
References:
Clinical trial NCT06619431: Pilot Test of a Mobile App That Helps Spanish-speakers Find Mental Health Services in the US.
Official title: Rumbo: an Integrated Mobile and Web-Based Application to Overcome Barriers to Receive Substance Use Disorder (SUD) Treatment and Improve Outcomes for Spanish-Speaking, Hispanic and Latinx Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Disparity, Minority and Vulnerable Populations
Keywords: Consumer health informatics
Health Disparities
Treatment access for hispanics/latinos
Lead sponsor: Volver Health
Sponsor class: INDUSTRY
Collaborators: name: Boston University
name: Pacific Institute for Research and Evaluation
name: National Institute on Drug Abuse (NIDA)
name: National Institute on Drug Abuse (NIDA) (DA038095)
First posted: 2024-10-01
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hispanic/Latine community sample

Brief summary: The goal of this observational study is to develop and test a mobile app for Spanish speakers residing in the US who seeking drug treatment and/or behavioral health services for themselves or an associate. The main questions it aims to answer are:

What are the features and content needed on this app?

How will people use and share this app?

Will they connect with treatment services?

After receiving input from focus group participants and other community stakeholders, the app was made available and its usage was tracked to determine its long-term, broad-scale feasibility.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Identify as Hispanic/Latino
* Own a smartphone, pad, or computer
* Be willing to meet with study personnel more than once

Exclusion Criteria:

* Age less than 18 or more than 75
* Evidence of significant cognitive impairment

Primary outcomes:
measure: System Usability Scale
timeFrame: From enrollment to the close of end-user testing after 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Volver Health
state: New Mexico
Study officials:
affiliation: Volver Health
name: William P Campbell
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03056131: Diacutaneous Fibrolysis, Effects on Tension Type Headache
Official title: Diacutaneous Fibrolysis, Effects on Tension Type Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tension-Type Headache
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 82
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: Tension Type Headache (TTH) is a frecuent type of headache disorder (about 1 person in 5 worldwide). Individuals with TTH typically present pericraneal tenderness and an increased cervical muscle tone.

The most common treatment in primary care consists mainly on analgesic medication. However, different techniques of manual therapy have been shown to be effective in the treatment of these patients. Diacutaneous fibrolysis shows clinical benefits in relieving symptoms of tension type headache, but there is no scientific evidence that analyzes this effects.

The hypothesis of this study was that adding treatment with diacutaneous fibrolysis to the usual conservative treatment has beneficial effects on different variables of the headache.

The aim of the study was to assess the effect of diacutaneous fibrolisis on intensity, frequency, duration of headache and cervical function in patients with tension type headache.

A randomized controlled clinical trial has been designed to evaluate the effectiveness of diacutaneous fibrolysis technique compared to usual general practicioner care in patientes with tension type headache.

The study protocol has been approved by the Clinical Research Ethics Committee from the Aragon Community and all patients provided written consent.

Eighty-two people with clinical diagnosis of TTH were randomized into a intervention group or a control group. Intervention group received three sessions of Diacutaneous Fibrolysis, while control group was advised to maintain their usual pharmacologic treatment. Pain intensity (VAS), frecuency, location, cervical range of motion, head forward position and pressure pain thresholds (PPTs) were measured at baseline, postintervention, and 1 month follow-up after treatment. The Spanish version of the HIT-6 Questionnaire was used to measure disability/function at baseline and follow-up.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Tension-Type Headache according to the criteria of ICDH-III.

Exclusion Criteria:

* Currently undergoing physiotherapy treatment for headache
* Modification of pharmacological treatment in the last month
* Presence of red flags

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: 10 days
Secondary outcomes:
measure: Change in Pain Frequency
timeFrame: 10 days
measure: Pressure Pain Threshold
timeFrame: 10 days
measure: Pericraneal tenderness
timeFrame: 10 days
measure: Cervical Range of motion
timeFrame: 10 days
measure: Dissability
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01726231: Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion
Official title: Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Surgical Procedures
Keywords: Laparoscopic access
Abdominal wall lifting
Direct trocar insertion
Safety endoscopy
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2012-11-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: the patiens undergoing laparoscopic surgery for various indications

Brief summary: In laparoscopy, over %50 of the all complications occur during establishment of the pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance between the abdominal wall and the intrabdominal structures. Elevation of the anterior abdominal wall is recommended for the access to peritoneal cavity in literatures however the benefit exactly has not proved. This study aimed to determine the distance from anterior abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to represent this distance -on the average- generate the safe range whether or not and compare with this distance and patient's age, BMI and parity.

Detailed description: 40 patients who undergoing laparoscopic surgery for various indications are enrolled in the study. The telescope is inserted at second trocar place and the distances between anterior abdominal wall and visceral organs are measured with plastic hysterometry during maximal elevation of the abdominal wall.

Eligibility criteria: Inclusion Criteria:

* the patients who performed laparoscopic surgery

Exclusion Criteria:

* the patients who suspected pregnancy
* large scale intrabdominal mass

Primary outcomes:
measure: The primary outcome measure of this study is to determine the distance in centimeters from anterior abdominal wall to intraperitoneal visceral structures during lifting of the abdominal wall with plastic hysterometry.
timeFrame: 2-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Training and Research Hospital
Study officials:
affiliation: Bagcilar Training and Research Hospital, Istanbul, Turkey
name: TANER A USTA, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02787031: Variations in Anesthesia Care for Hip Fracture Surgery
Official title: Sources of Variation in Anesthesia Care for Hip Fracture Surgery and the Association With Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Anesthesia
Death
Keywords: hip fracture
geriatric
epidemiology
practice variation
anesthesia
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 107317
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Ontario residents aged 66 years or older on the day of their emergency hip fracture surgery.

Brief summary: The investigators will use health administrative data to examine the variation of anesthesia type for hip fracture surgery, as well as sources of variation and predictors of variation.

Detailed description: To evaluate the sources of variance in utilization of neuraxial anesthesia the investigators will use multilevel multivariable modeling strategies. This will allow identification of sources of variation (hospital, vs physician, vs patient characteristics), as well as identification of independent predictors of neuraxial use at each of these three levels.

The investigators will also evaluate the independent association of hospital level variation in neuraxial use on our outcomes of interest using multilevel multivariable regression.

Eligibility criteria: Inclusion Criteria:

* Had hip fracture surgery
* Admitted to hospital on a non-elective basis

Exclusion Criteria:

* Do not hold a valid provincial health insurance account

Primary outcomes:
measure: Number of Participants With All-Cause Mortality at 30-days
timeFrame: Day of surgery to day of death, or up to 30 days, whichever comes first
Secondary outcomes:
measure: Healthcare Costs From the Perspective of the Universal Healthcare System, Using Standardized Methods (Health System Performance Research Network 2013)
timeFrame: Day of surgery to day of death, or 30 days after surgery, whichever comes first
Other outcomes:
measure: Hospital Length of Stay
timeFrame: Day of surgery to day of discharge, or up to 365 days, whichever comes first
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Daniel McIsaac, MD,MPH,FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: McIsaac DI, Wijeysundera DN, Bryson GL, Huang A, McCartney CJL, van Walraven C. Hospital-, Anesthesiologist-, and Patient-level Variation in Primary Anesthesia Type for Hip Fracture Surgery: A Population-based Cross-sectional Analysis. Anesthesiology. 2018 Dec;129(6):1121-1131. doi: 10.1097/ALN.0000000000002453.
Clinical trial NCT04005131: Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation in Chronic Stroke
Official title: Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Upper Extremity Function Among Subjects With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
transcranial direct current stimulation
upper extremity rehabilitation robot
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2019-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of real transcranial direct current stimulation (tDCS) and sham tDCS combined with robot training for upper extremity rehabilitation in subjects with chronic stroke - delayed start study.


Eligibility criteria: Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Onset ≥ 6 months
* Fugl-Meyer Assessment score ≥ 19
* Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

* Severe upper extremity pain that could interfere with rehabilitation therapy
* Neurological disorders other than stroke that can cause motor deficits
* Uncontrolled severe medical conditions.

Primary outcomes:
measure: kinematic data during scale for the assessment
timeFrame: 5 weeks after baseline
Secondary outcomes:
measure: kinematic data during scale for the assessment
timeFrame: baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Fugl-Meyer Assessment - upper extremity
timeFrame: baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Wolf Motor Function Test
timeFrame: baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Motor activity log
timeFrame: baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
measure: Action reach arm test
timeFrame: baseline, 1 weeks after baseline, 5 weeks after baseline, 6 weeks after baseline, 10 weeks after baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Rehabilitation Center
Study officials:
affiliation: National Rehabilitation Center
name: Joon-Ho Shin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01008631: The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers
Official title: The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Keywords: renal failure
sodium Thiosulfate
pharmakokinetic
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The pharmacokinetics of sodium thiosulfate in humans with different degrees of renal failure and in healthy volunteers will be after two single shot applications.

Detailed description: Two single shot applications of i.v. sodium thiosulfate will be given to dialysis patients. One application will be given immediately before a dialysis session and the second dose will be given after the consecutive dialysis session.

In healthy volunteers sodium thiosulfate will be given only once. In both groups, dialysis patients and healthy volunteers, blood and urinary/dialysate samples will be collected at defined time points.

Eligibility criteria: Inclusion Criteria:

* healthy volunteer or patient with renal failure

Exclusion Criteria:

* pregnancy
* withdrawal of consent

Primary outcomes:
measure: Elimination half life in dependence of the degree of renal failure
timeFrame: 0, 15, 30, 60, 180 minutes and 24 hours after application
Secondary outcomes:
measure: Changes in acid-base parameter after application of sodium thiosulfate
timeFrame: 0, 15, 30, 60, 180 minutes and 24 hours after application
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Department of Nephrology and Hypertension, University of Berne
Study officials:
affiliation: University of Berne
name: Stefan Farese, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farese S, Stauffer E, Kalicki R, Hildebrandt T, Frey BM, Frey FJ, Uehlinger DE, Pasch A. Sodium thiosulfate pharmacokinetics in hemodialysis patients and healthy volunteers. Clin J Am Soc Nephrol. 2011 Jun;6(6):1447-55. doi: 10.2215/CJN.10241110. Epub 2011 May 12.
Clinical trial NCT02268331: Comparison of Active vs. Passive Surveillance to Collect Adverse Events
Official title: Comparison of Active vs. Passive Surveillance to Collect Adverse Events After Chiropractic Manual Therapy in the Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Events
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This cluster randomized trial will be the first to specifically evaluate passive versus active surveillance methods collection of adverse events (AEs). The evaluation of these methods will be performed within the chiropractic healthcare profession, specifically among those who treat children. To date there is no mandatory reporting and learning as part of their profession. In Europe, a passive (voluntary) reporting and learning online system (CPiRLS) has been created and will be utilized in this study for the passive reporting and learning arm.

Manual therapy is the most common intervention provided by the chiropractic profession and is the most commonly sought provider-administrated complementary and alternative therapy in the United States pediatric population. This study will randomize participating doctors of chiropractic who often treat children, to of one of two arms (active vs. passive reporting and learning) to evaluate the quantity and quality of AE data collected.


Eligibility criteria: Inclusion Criteria:

* Licensed doctors of chiropractic who provide manual therapy in US or Canada
* Willing to collect data per protocol for 60 consecutive pediatric (13 years of age and younger) patients

Exclusion Criteria:

- Doctors of chiropractic and patient participation will be limited to those that speak / read English.

Primary outcomes:
measure: Adverse event occurring after treatment
timeFrame: Up to one week after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: CARE
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sunita Vohra, MD, FRCPC, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pohlman KA, Carroll L, Tsuyuki RT, Hartling L, Vohra S. Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial. Trials. 2017 Dec 1;18(1):575. doi: 10.1186/s13063-017-2301-0.