louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04686526: Wearable Electrocardiogram Monitoring Device and Smartphone Application in Perioperative Pain Management
Official title: Development of a Wearable Electrocardiogram Monitoring Device and Smartphone Application in Perioperative Pain Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain, Postoperative
Keywords: heart rate variability
postoperative pain
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing major abdominal surgical procedures in Peking Union Medical College Hospital

Brief summary: This study aims to develop a wearable electrocardiograph monitoring device and smartphone application in perioperative pain management, also to evaluate relationship between postoperative pain and heart rate variability.

Detailed description: This study is a prospective observational cohort study implementing wearable electrocardiogram (ECG) monitor device and smartphone application in perioperative pain management. Patients undergoing major abdominal surgical procedures will be recruited to wear a ECG monitor device from the day before surgery until 1-3days after surgery. Patients will report their condition of pain twice daily on the corresponding smartphone application based on a structured and visualized pain report module. Patients will receive a telephone follow-up 30/60/90/365 days after surgery for assessment of postoperative chronic pain. A pilot study will be conducted to evaluate acceptability, safety and feasibility of the device and application using system usability scale and comprehensive product quality assessment. Further study will be conducted to evaluate the relationship between postoperative acute and chronic pain and heart rate variability (HRV) acquired from ECG device.

Eligibility criteria: Inclusion Criteria:

* patients undergoing major abdominal surgical procedures;
* 18-65 years old;
* ASA classification: I-IV
* able to read and understand how to use the App after instruction；
* written informed consent obtained.

Exclusion Criteria:

* current participation in other mobile device research or perioperative pain research;
* inability to use the device;
* inability to obtain consent.

Primary outcomes:
measure: Incidence of moderate to severe acute post-operative pain
timeFrame: Postoperative Day 1 to 3
Secondary outcomes:
measure: Incidence of chronic post-surgical pain
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Li Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04157426: Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae
Official title: Effectiveness of Ultrasound-guided Interventions of Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae Active Myofascial Trigger Points
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Point Pain, Myofascial
Myofascial Pain
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective will be to determine the effectiveness of ultrasound-guided percutaneous electrolysis versus ultrasound-guided dry needling in active myofascial trigger points of the levator scapulae muscle on pain intensity, disability and range of motion. A randomized clinical trial will be carried out. Fifty-four patients with at least one active myofascial trigger point in the levator scapulae muscle were recruited and divided into ultrasound-guided percutaneous electrolysis (n = 27) and ultrasound-guided dry needling (n=27). Pain intensity, disability and range of motion will measured before, immediately after and 1 week after intervention.


Eligibility criteria: Inclusion Criteria:

* Neck pain
* At least two active myofascial trigger point in the levator scapulae muscle

Exclusion Criteria:

* Systemic diseases
* Cognitive impairment

Primary outcomes:
measure: Pain intensity
timeFrame: Change from baseline pain intensity immediately and at 1 week after intervention
Secondary outcomes:
measure: Disability
timeFrame: Change from baseline pain intensity at 1 week after intervention
measure: Range of motion
timeFrame: Change from baseline pain intensity immediately and at 1 week after intervention
Other outcomes:
Locations:
city: Fuenlabrada
country: Spain
facility: Fisiofuenla SLP
state: Madrid
Study officials:
References:
Clinical trial NCT01283126: Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery
Official title: Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoglycemia
Keywords: Hypoglycemia, cognitive function
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: Abbott Diabetes Care
First posted: 2011-01-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy individuals and how well changes in (interstitial) tissue glucose levels correlate with changes in cognitive function as compared to blood glucose levels.

Detailed description: Subjects will undergo hypoglycemic clamps during which interstitial glucose will be measured and cognitive function will be assessed.

Eligibility criteria: Inclusion Criteria:

* non obese (BMI \<30), ages 18-50

Exclusion Criteria:

* renal or hepatic failure
* cancer or lymphoma
* malabsorption or malnourishment
* hypercortisolism
* alcoholism or drug abuse
* anemia
* eating disorder or depression
* coronary artery disease
* Arrhythmias
* hypertension
* on medications known to affect the blood glucose to be measured such as
* glucocorticoids
* on blood thinning agents

  * Pregnant women, breastfeeding women and women who want to become pregnant in the next 6 months will be excluded from the study.
  * Subjects who have donated blood two weeks prior to the study.
  * Allergies to pig derived products (Heparin will be used)

Primary outcomes:
measure: cognitive function correlation to blood or interstitial glucose
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Howard Wolpert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Joslin Diabetes Center
name: Greeshma K Shetty, MD
role: STUDY_CHAIR
affiliation: Joslin Diabetes Center
name: Gail Musen, PhD
role: STUDY_CHAIR
affiliation: Brigham and Women's Hospital
name: Gail Adler, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02437526: Analytic Treatment Interruption (ATI) to Assess HIV Cure
Official title: Analytic Treatment Interruption of Antiretroviral Therapy to Assess for HIV Cure
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: HIV
Keywords: Cure
Analytic treatment interruption
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-05-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to determine if individual patients with HIV infection have been cured of the infection. To do this, antiretroviral therapy is discontinued under close medical supervision and the patient monitored over time for reactivation of infection.


Eligibility criteria: Inclusion Criteria

* Age ≥ 18 years
* HIV-1 infected with the potential to have been cured of infection in the course of routine clinical care in the opinion of the treating physician and study team
* Have an undetectable plasma HIV-1 RNA and undetectable proviral DNA on suppressive antiretroviral therapy on at least two consecutive measures for at least 6 months
* Able and willing to either abstain from sexual activity or use barrier contraceptives during the ATI
* Negative serum β-HCG pregnancy test in women with childbearing potential
* Have the ability to give appropriate informed consent.

Exclusion Criteria

* Women who are pregnant or nursing
* Women who can become pregnant who are unable or unwilling to use both barrier and pharmacologic contraceptives during the ATI
* Previous or current infections that are at high risk of reactivating with immune suppression, in whom there are no effective antimicrobial prophylaxis options
* Advanced cardiopulmonary or liver disease
* History of untreated solid or hematologic malignancies
* Evidence of active viral replication in patients co-infected with Hepatitis B virus (HBV). Treatment should be provided to suppress HBV replication with agents that do not have activity against HIV (ie entecavir) prior to consideration for ATI.
* Evidence of viral replication with Hepatitis C virus (HCV), together with evidence of any hepatic fibrosis or inflammation. Such patients should be offered HCV treatment first.

Primary outcomes:
measure: Time to virologic rebound
timeFrame: 38 weeks
Secondary outcomes:
measure: Time to HIV-1 RNA ≥ 20 copies/ml
timeFrame: 38 weeks
measure: Time to HIV-1 RNA ≥ 100 copies/ml
timeFrame: 38 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Andrew Badley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03838926: Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
Official title: Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsed or Refractory Hematologic Malignancies
Keywords: Hematologic
Malignancies
Cancer
Blood
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-02-12
Enrollment: 42
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: The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.


Eligibility criteria: Inclusion Criteria:

* Subject is ≥ 18 years at the time of signing informed consent;
* Confirmed malignant hematologic disease or lymphoid malignancy that has relapsed or is refractory to standard therapy and has exhausted all available therapies;
* Presence of measurable or evaluable disease;
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
* Contraceptives or other approved avoidance of pregnancy measures

Exclusion Criteria:

* Allogeneic stem cell transplant recipient presenting with graft versus host disease (GVHD) either active or requiring immunosuppression;
* Concomitantly taking anti-cancer therapy (bisphosphonates are permitted);
* Undergone major surgery ≤ 2 weeks prior to starting study drug;
* Evidence of mucosal or internal bleeding;
* Impaired cardiac function or conduction defect;
* Concurrent severe and/or uncontrolled medical conditions

Primary outcomes:
measure: Safety and tolerability of trichostatin A measured by spontaneous reporting of adverse events (AEs)
timeFrame: Up to 24 months
measure: Dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) of trichostatin A
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Vanda Investigational Site
state: District of Columbia
city: Lafayette
country: United States
facility: Vanda Investigational Site
state: Indiana
city: Fairway
country: United States
facility: Vanda Investigational Site
state: Kansas
city: Hackensack
country: United States
facility: Vanda Investigational Site
state: New Jersey
city: Seattle
country: United States
facility: Vanda Investigational Site
state: Washington
Study officials:
References:
Clinical trial NCT00855426: Diagnostic Protocol Of Painful Hip
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Hip Fracture
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-03-04
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients that are admitted to the ER after trauma.

Brief summary: Nondisplaced hip fractures may be radiographically occult and require MRI or single photon emission CT bone scintigraphy for accurate diagnosis. Both examinations are expensive and are not readily available in many hospitals. Ultrasound (US) examination is relatively inexpensive and preliminary data had demonstrated its efficacy in detecting occult fractures in other sites. Our objective is to evaluate US examination as a screening tool for occult hip fractures in posttraumatic painful hips in the elderly.


Eligibility criteria: Inclusion Criteria:

1. Men and women above 40 years old
2. Trauma to the hip .
3. Extreme difficulty in walking or inability to step on the leg, following sensitivity in the hip joint area after local pressure or in a movement.
4. X ray of the pelvis aimed to the suspected hip joint (including AP lateral position and internal rotation) does not demonstrate fracture in the joint or the pelvis.

Exclusion Criteria:

1. None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00174226: Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar
Official title: Eight-Week, Double-Blind, 3-Arm Parallel, Placebo-Controlled, Randomized Efficacy And Safety Trial Of Atomoxetine, Atomoxetine Plus Buspirone, And Placebo In Adults With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 241
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: Determine if there is a difference in treatment response for adults with ADHD who are treated with Strattera versus those treated with a combination of Strattera and buspirone


Eligibility criteria: Inclusion Criteria:

* Adults with ADHD

Exclusion Criteria:

* Other Axis I Psychiatric Disorders

Primary outcomes:
measure: To assess the efficacy of Atomoxetine-Buspirone (ATX-BSP) vs placebo (PBO) and atomoxetine (ATX) monotherapy in adult patients with ADHD as measured by the mean change across 7 weeks in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score
Secondary outcomes:
measure: To characterize the safety over 8 weeks of ATX-BSP as compared to PBO and ATX monotherapy. To assess the response rate for the 3 treatment groups based on AISRS and CGI scores.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Woodstock
country: United States
facility: Pfizer Investigational Site
state: Vermont
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sutherland SM, Adler LA, Chen C, Smith MD, Feltner DE. An 8-week, randomized controlled trial of atomoxetine, atomoxetine plus buspirone, or placebo in adults with ADHD. J Clin Psychiatry. 2012 Apr;73(4):445-50. doi: 10.4088/JCP.10m06788. Epub 2012 Jan 10.
Clinical trial NCT01912326: Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
Official title: Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Atrial Fibrillation
Keywords: pacemaker
atrial fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-07-31
Enrollment: 249
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming.

Hypothesis:

Dynamic atrial Overdrive (AF Suppression) reduces AT/AF Burden by 30% as compared to programming DDDR-(60) without AF Suppression when all other parameters are optimized.

Detailed description: Atrial Fibrillation is the most common Heart Rhythm Disorder requiring therapy.

Eligibility criteria: Inclusion Criteria:

* indication for dual chamber pacemaker
* documented paroxysmal or persistent Atrial Fibrillation
* P-wave \>1.0 mV in Sinus Rhythm or sufficient detection of AFib
* stable antyarrhythmic therapy
* age \>= 19 years
* written informed consent
* implantation of a Identity DR 5370/5376 or later
* bipolar atrial lead

Exclusion Criteria:

* permanent AFib
* reversible etiology of AFib
* HYHA II or IV
* Coronary Artery disease with stable angina pectoris
* implanted ICD or planned implantation of a ICD
* cardiac surgery within the last 6 months or planned within 12 months
* live expectancy \< 12 months
* pregnancy

Primary outcomes:
measure: Reduction of AT/AF Burden in the pacemaker diagnostics
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn AdöR
Study officials:
References:
Clinical trial NCT06138626: Test of Excessive Anesthetic Fresh Gas Flow Alerting in the Electronic Medical Record to Reduce Excessive Fresh Gas Flow
Official title: Anesthetic Fresh Gas Flow Alert Test
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anesthesia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary objective of this quality improvement intervention is to test the efficacy of excessive fresh gas flow alerting in the electronic medical record for anesthesia providers.


Eligibility criteria: Inclusion Criteria:

* Anesthesia provider using electronic medical record at study site

Exclusion Criteria:

* None

Primary outcomes:
measure: Mean change in average fresh gas flow from baseline at 90 days
timeFrame: Baseline, day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT03585426: Vancomycin in the Target Site Treatment of Intracranial Infection
Official title: Vancomycin in the Target Site Treatment of Intracranial Infection : a New Strategy for PK/PD Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vancomycin
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 2
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: Vancomycin, a novel intravenously administered antibiotic, currently plays a key role in the management of complicated multi-organism infections. However,current LC-MS/MS methods briefly describe parameters and the only reported internal standard was sometimes difficult to obtain. In our study,an updated LC-MS/MS method for the quantitative analysis of vancomycin in human serum was developed.


Eligibility criteria: Inclusion Criteria:

In ICU; ventricle drainage was carried out; renal function is normal, namely creatinine clearance rate is \>60ml/min;

Exclusion Criteria:

women in pregnancy or lactation;in patients with renal insufficiency, the creatinine clearance rate (Clcr) is less than 60ml/min.

Primary outcomes:
measure: Vancomycin concentration change in serum and cerebrospinal fluid
timeFrame: 0.5h, 1h, 1.5h, 3h, 5h, 7h, 9h, and 12h after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital, the Fourth Military Medical University
name: Yanyan Jia, Dr.
role: STUDY_DIRECTOR
References: