louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04877574: ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia
Official title: Effects of Analgesia Nociception Index (ANI)-Guided Intraoperative Analgesia on Postoperative Pain: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Analgesia
Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effects of Analgesia Nociception Index (ANI)-guided intraoperative analgesia on postoperative pain in patients undergoing open gynecologic surgery.

Detailed description: Postoperative pain is one of the most common postoperative complications and is significantly associated with patient's quality of recovery. Analgesia Nociception Index (ANI) is known to analyze the high frequency component of heart rate variability in relation to respiratory frequency, providing the objective information on the degree of pain. However, most previous studies conducted by using ANI were observational studies or small-sized randomized controlled studies. In the present study, the investigators aimed to evaluate the effects of ANI-guided intraoperative analgesia on moderate-to-severe postoperative pain by performing randomized controlled study.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Elective open gynecological surgery
* American Society of Anaesthesiologists physical status classification 1-3

Exclusion Criteria:

* Laparoscopic surgery or robot-assisted surgery
* Patients who had analgesic agents, anti-psychotic agents, anticonvulsants which were related to chronic pain
* Patients who had hypersensitivity to analgesic agents or medications related anesthesia.
* Patients who were required to have mechanical ventilation after surgery
* Patients who had arrhythmia
* Patients who transferred to the surgical intensive care unit immediately after surgery
* Pregnancy

Primary outcomes:
measure: the incidence of moderate-to-severe postoperative pain
timeFrame: during 1 hour of stay in the postanesthesia care unit
Secondary outcomes:
measure: the amount of intraoperative remifentanil
timeFrame: intraoperative
measure: Quality of Recovery-15 (QoR-15) score
timeFrame: at postoperative 24 hour
measure: the incidence of postoperative nausea and vomiting
timeFrame: at postoperative 1 hour, 24 hour, 72 hour
measure: 11-pointed NRS pain score
timeFrame: at postoperative 24 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01428674: Time, Touch, Attention and the Autonomic Nervous System
Official title: The Impact of Interpersonal Mindful Compassion on Autonomic Nervous System Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Interpersonal mindful compassion
Loving kindness meditation
Autonomic Nervous System
Heart rate variability
Respiratory rate
Relaxation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-09-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe the onset, duration and dose-response of interpersonal mindful compassion on respiratory rate and heart rate variability in healthy adults in order to prepare for research evaluating the impact of this intervention in patient populations and to prepare for basic research investigating the CNS mechanisms for observed effects.

Previous research has found that mindfulness meditation, including mindful compassion, results in autonomic changes in the practitioner. Emerging neuroscience of dyadic interactions suggests that through the effects of mirror neuron isopraxis, one person's physiologic state may be mirrored by another. However, no research has directly evaluated the impact of one person's mindful compassion on another person's autonomic activity. This study paves the way for an entirely new avenue of research inquiry.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects age 18 - 40

Exclusion Criteria:

* Taking beta blocker medication

Primary outcomes:
measure: Change in Heart Rate Variability from pre-intervention period to intervention period
timeFrame: continuous monitoring for 10 min before intervention and during 10 or 20 minute intervention
measure: Change in Respiratory Rate from pre-intervention period to intervention period
timeFrame: continuous monitoring for 10 minutes before intervention and during 10 or 20 minute intervention
Secondary outcomes:
measure: Perceived Stress, Relaxation, Peacefulness
timeFrame: baseline, after a 10 minute rest period, before 10 or 20 minute intervention, immediately after intervention, 20 minutes after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kathi J Kemper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kemper KJ, Shaltout HA. Non-verbal communication of compassion: measuring psychophysiologic effects. BMC Complement Altern Med. 2011 Dec 20;11:132. doi: 10.1186/1472-6882-11-132.
Clinical trial NCT02272374: Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China
Official title: Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China :a Multicenter Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Hemodialysis
Arteriovenous fistula
Tunneled cuffed catheter
Arteriovenous graft
Elderly
Very elderly
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Zhejiang University
name: Zhongda Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Sichuan Provincial People's Hospital
name: The Second Affiliated Hospital of Dalian Medical University
name: Beijing Haidian Hospital
First posted: 2014-10-22
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the clinical outcomes and cost-effectiveness of different vascular access(arteriovenous fistula, tunneled cuffed catheter and arteriovenous graft) in the elderly and very elderly with end-stage renal disease in China.


Eligibility criteria: Inclusion Criteria:

1. The elderly and very elderly with end stage renal disease.
2. Estimated glomerular filtration rate (eGFR) \<20ml/min\*1.73m2
3. All study subjects agree to participate in the study and provide written informed consent.

Exclusion Criteria:

1. Patients' life expectancy is less than 2 years.
2. Mental illness that makes the patients unable to complete the trial.

Primary outcomes:
measure: The patency rate of vascular access
timeFrame: 2 years
measure: Effect of vascular access construction on ventricular volumes and left ventricular remodeling
timeFrame: 2 years
measure: Effect of vascular access construction on brain MRI and cognitive functionslesions and cognitive function
timeFrame: 2 years
Secondary outcomes:
measure: Complications of vascular access
timeFrame: 2 years
measure: Cost-effectiveness of different vascular access
timeFrame: 2 years
measure: Hospitalization rate due to vascular access.
timeFrame: 2 years
measure: Mortality due to vascular access
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
Study officials:
affiliation: Division of Nephrology, Shanghai ChangZheng Hospital
name: Changlin Mei, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01088074: A Comparative Study of Incision Closure Methods for Total Knee Replacement
Official title: A Comparative Study of Incision Closure Methods for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Replacement Closure
Wound Closure
Keywords: Total Knee Replacement
Closure Methods
Lead sponsor: Foundation for Southwest Orthopedic Research
Sponsor class: OTHER
First posted: 2010-03-17
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare incision closure techniques for total knee replacement using a combination of state-of-the-art sutures with tissue adhesives or staples in an effort to identify the best approach with respect to time efficiency, cost, durability, dehiscence, microbial resistance and cosmesis.

The hypothesis is that the combined suture/adhesive approach (sutures for capsule and subcutaneous layers, and tissue adhesive for the final cutaneous layer) or suture/staple approach will be significantly faster and of comparable durability as the conventional exclusive suture approach (sutures used for the capsule, subcutaneous, and cutaneous layers). This is a prospective, randomized, controlled, single site, unblinded (open label) study.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria included 18 years or older
* TKA scheduled without a bilateral planned within one week of the initial surgery
* Willingness to attend prescribed physical therapy 3 times per week.

Exclusion Criteria:

* Exclusion criteria included medical conditions or personal circumstances that would prevent participation and completion of physical therapy and follow-up visits
* Current participation in another clinical trial
* Preoperative systemic infections
* Uncontrolled diabetes, or diseases or conditions known to effect the wound healing process
* Known hypersensitivity to cyanoacrylate
* Formaldehyde, or the dye D\&C Violet #2
* Prior knee hardware fixation devices
* Prior knee incisions greater than 9cm, and arthrofibrosis as evidence by limited ROM less than 80°.

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: 1/2009-10/2009
Secondary outcomes:
measure: Mean postop hospital stay
timeFrame: 1/2009-10/2009
Other outcomes:
Locations:
city: Houston
country: United States
facility: Foundation for Southwest Orthopedic Research
state: Texas
Study officials:
References:
Clinical trial NCT03929874: Ultrasound Image Study for Ultrasound-assisted Paramedian Spinal Anesthesia
Official title: Ultrasound Image Study for Ultrasound-assisted Paramedian Spinal Anesthesia: Difference in Sidedness of Approach, Position and Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Spinal
Ultrasonography
Sidedness
Position
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under 40 orover 60 years of age who require spinal anesthesia for orthopedic surgery, with ASA physical status classification system I, II, III

Brief summary: This prospective observational study aimed to obtain ultrasound images for ultrasound-assisted paramedian spinal anesthesia and identify the differences according to sidedness of approach, position and age.


Eligibility criteria: Inclusion Criteria:

* Patients under 40 or over 60 years of age who require spinal anesthesia for orthopedic surgery,
* with ASA physical status classification system I, II, III

Exclusion Criteria:

* Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)
* Patients with communication difficulties
* Patient who can not take a sitting or lateral decubitus position (fracture)
* Patients with a history of spinal surgery
* Patient with anatomical abnormality of the spine

Primary outcomes:
measure: Ultrasonic visualization grading at left L3-4, L4-5, L5-S1 interspace and right L3-4, L4-5, L5-S1 interspace in lateral decubitus position and sitting position
timeFrame: Preanesthesia
measure: Distance between the midline and the expected location of needle insertion
timeFrame: Preanesthesia
measure: Height of LFD through interlaminar space
timeFrame: Preanesthesia
measure: Depth from skin to LFD
timeFrame: Preanesthesia
measure: Depth from skin to PLL
timeFrame: Preanesthesia
measure: Width of the intrathecal space
timeFrame: Preanesthesia
Secondary outcomes:
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 Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4.
citation: Bae J, Park SK, Yoo S, Lim YJ, Kim JT. Influence of age, laterality, patient position, and spinal level on the interlamina space for spinal puncture. Reg Anesth Pain Med. 2019 Nov 4:rapm-2019-100980. doi: 10.1136/rapm-2019-100980. Online ahead of print.
Clinical trial NCT05537974: Open Suction vs. Closed Suction in ARDS
Official title: Effect of Endotracheal Aspiration on End-expiratory Lung Volume in Patients With ARDS, Comparison of Open vs. Closed Suction, A Randomize Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: Endotracheal aspiration, Electric impedance tomography
Lead sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a crossover study and suction procedure was made in a random order with 60 minutes wash out period between two suction maneuvers. Patients were randomized after intubation; randomization was made with sealed envelopes.

All patients mechanically ventilated with lung protective ventilation strategy. Before the suctioning the patients ventilated with 100% of oxygen for 60 seconds. In open suction, the patient was disconnected from mechanical ventilator, the aspiration catheter advanced until resistance met after that the catheter withdraw 1 cm before aspiration. During endotracheal suctioning a negative pressure applied two times for 5 seconds. The negative pressure was set 150 mmHg. All suctioning maneuvers performed by intensivists.
Primary purpose: SCREENING

Brief summary: The alveoli tend to collapse in patients with ARDS. Endotracheal aspiration may increase alveolar collapse by decreasing the end-expiratory lung volume. The hypothesis is that closed endotracheal aspiration led to less end-expiratory volume loss when compared to open endotracheal aspiration.


Eligibility criteria: Inclusion Criteria:

Mechanically ventilated due to ARDS

Exclusion Criteria:

Hemodynamically unstable Air leaks syndrome (pneumothorax) Higher level of FiO2 (\>60%) Chronic obstructive pulmonary disease

Primary outcomes:
measure: End expiratory lung volume (EELV)
timeFrame: One minute before suctioning, 1, 10, 20, 30 minutes after suctioning
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit
Study officials:
References:
Clinical trial NCT03181074: Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults
Official title: Early Post-marketing Study of Daclatasvir (Daklinza) in the Treatment of Chronic Hepatitis C (CHC) in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic Hepatitis C who are being given daclatasvir for the treatment and cure of chronic Hepatitis C at the sentinel sites for the CNFV in Mexico. Patients will be treated according to the clinical judgment of the treating physician.

Brief summary: This early post-marketing study is an observational, prospective and descriptive study of patients receiving daclatasvir for the treatment of Chronic Hepatitis C at participating sentinel sites for the CNFV in Mexico.


Eligibility criteria: Inclusion Criteria:

1. This study will include patients greater than or equal to 18 years of age with chronic Hepatitis C, all genotypes, including naïve and experimented (null or partial) responders, intolerant to interferon (IFN) with or without cirrhosis, HIV/HCV coinfection, and liver transplant recipients at the sentinel sites, who received at least 1 dose of daclatasvir for the treatment of chronic Hepatitis C during the specified 24-month study period.

Exclusion Criteria:

1. Subjects who received daclatasvir as part of a clinical trial.
2. Subjects who received daclatasvir for any indication other than local approved.
3. Contraindications included in the approved Mexican prescribing information.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: Approximately 24 months
Secondary outcomes:
measure: Distribution of Adverse Events by Age
timeFrame: Approximately 24 months
measure: Distribution of Adverse Events by Gender
timeFrame: Approximately 24 months
measure: Distribution of Adverse Events by Interruption or Switch of Medication
timeFrame: Approximately 24 months
measure: Distribution of Adverse Events by Concomitant Medication
timeFrame: Approximately 24 months
measure: Distribution of Adverse Events by Race
timeFrame: Approximately 24 months
Other outcomes:
Locations:
city: Benito Juarez
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico, D.f.
country: Mexico
facility: Local Institution
state: Distrito Federal
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06160674: Vowel Segmentation for Classification of Chronic Obstructive Pulmonary Disease Using Machine Learning
Official title: Vowel Segmentation for Classification of Chronic Obstructive Pulmonary Disease Using Machine Learning
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Segmentation
Classification
COPD
Machine Learning
Lead sponsor: Blekinge Institute of Technology
Sponsor class: OTHER
Collaborators: name: Excellence Center at Linköping - Lund in Information Technology (ELLIIT)
First posted: 2023-12-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected from participants 18 years old and older with and without COPD diagnosis will be recruited.

Brief summary: This work aims to evaluate whether the segmentation of vowel recordings collected from patients diagnosed with COPD and healthy control groups can increase the classification precision of machine learning techniques.

Detailed description: Voice data and sociodemographic data on gender and age will be collected through the "VoiceDiganostic" application from the company Voice Diagnostic. Collected vowel recordings will be segmented and tested to determine whether some segments contain more information for the discrimination of COPD from healthy control groups.

Each segment will be transformed into mathematical vocal measures called voice features. A dataset consisting of voice features in conjunction with demographics and health data will be constructed for each segment which in turn will be evaluated for classification performance using several machine learning algorithms.

Descriptive statistical analysis will be held on attributes containing information on input data and gained outcomes from ML algorithms. The achieved results will be presented in the form of summary tables and graphs.

Eligibility criteria: Inclusion Criteria:

* being 18 years old and older.

Exclusion Criteria:

* being under 18 years old and older.

Primary outcomes:
measure: Classification performance
timeFrame: 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karlskrona
country: Sweden
facility: Blekinge Institute of Technology
state: Blekinge
Study officials:
affiliation: Blekinge Institute of Technology
name: Johan Sanmartin Berglund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02027974: Post-Market Study of the ICONACY Hip System
Official title: ICONACY Hip Clinical Data Acquisition (13-1-M-239)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Degenerative Joint Disease
Keywords: Hip
Arthroplasty
Arthroplasties
Prosthesis
Iconacy
Osteoarthritis
Arthritis
THA
THR
DJD
Lead sponsor: Iconacy Orthopedic Implants, LLC.
Sponsor class: INDUSTRY
First posted: 2014-01-06
Enrollment: 0
Sex: ALL
Minimum age (years): 30
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 use and efficacy of the Iconacy Hip System for total hip replacement surgery.


Eligibility criteria: Inclusion Criteria:

* This must be a primary hip replacement on this hip
* Patient is 30 years of age or older
* Have hip joint disease related to one or more of the following: degenerative joint disease, including osteoarthritis or traumatic arthritis
* Patient is likely to be available for evaluation for the duration of the study
* Able and willing to sign the informed consent and follow study procedures

Exclusion Criteria:

* Is younger than 30 years of age
* If there has been a total hip replacement on this hip in the past (no revisions allowed in study)
* Infection, or history of infection, acute or chronic, local or systemic
* Alcoholism or other addictions
* Muscular, neurological or vascular deficiencies which compromise the affected extremity
* Obesity(BMI\>45)
* Insufficient bone quality
* Loss of ligamentous structures
* High levels of physical activity
* Materials sensitivity
* Prisoner
* Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
* Patient is pregnant
* Is not able to read English language

Primary outcomes:
measure: Radiographic success
timeFrame: 2 years
measure: Harris Hip Score must be > or = 80 at 2 years
timeFrame: 2 years
measure: Oxford Hip Score > 40 points at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Patient Satisfaction at 1, 2, and 3 years
timeFrame: 1, 2, and 3 years
measure: Improvement in Harris Hip Score from pre-surgery to 1, 2, and 3 years
timeFrame: 1, 2, and 3 years
measure: Improvements in Oxford Hip Score from pre-survey to 1, 2, and 3 years
timeFrame: 1, 2, and 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Eastern Maine Medical Center
name: William A Hodge, MD
role: PRINCIPAL_INVESTIGATOR
References: