louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03019562: Oxycodone vs. Fentanyl in Early Postoperative Pain After Total Hip Replacement
Official title: Oxycodone vs. Fentanyl in the Treatment of Early Postoperative Pain After Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: postoperative pain
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oxycodone is one of the most widely used opioids for pain treatment. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients after total hip replacement surgery.

Detailed description: Oxycodone is one of the most widely used opioids for pain treatment. There have been several studies on the efficacy and side effects of oxycodone. Oxycodone has been known to have the same potency with morphine. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we designed a prospective, randomized, and double-blind study to assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients who underwent the total hip replacement surgery.

Eligibility criteria: Inclusion Criteria:

* 19-65 years of age
* ASA physical status classification I or II
* Scheduled for total hip replacement surgery

Exclusion Criteria:

* Allergic to study drugs
* Patient with asthma or COPD, patient who is severely respiratory depressed
* Renal of hepatic insufficiency
* Epileptic status
* Intracranial lesion associated with increased intracranial pressure
* Acute abdomen, patient who has diagnosed paralytic ileus or suspicious ileus
* Pregnant or lactating women

Primary outcomes:
measure: Postoperative pain measurement using Numeric Rating Scale(NRS)
timeFrame: Immediately after surgery
Secondary outcomes:
measure: Additional doses of fentanyl for pain management
timeFrame: From immediately after surgery to 2 days after surgery
Other outcomes:
measure: Adverse effect
timeFrame: From immediately after surgery to 2 days after surgery
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
affiliation: Kyunghee University Medical Center
name: Mi Kyeong Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00966862: The Glycemic Effect of Taking a Supplementation of Orange Juice With Fibers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Healthy People
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-08-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: The aim of this study is to investigate the glycemic effect of supplementation Fibers in orange juice.

This will be a double-blind parallel controlled study. Each subject will serve as his own control.

Study population will include 10 subjects. The subjects will be randomly assigned to receive one of two juices in occasion, in two visits. Each drink will be containing orange juice with\\without fibers.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* Age 60 \>18 years
* Written informed consent
* Consumers of orange drinks: freshly squeezed juices, commercial pasteurized juices and / or orange soft drinks
* Regular eating pattern

Exclusion Criteria:

* Patients with chronic disease sach as:

  * diabetes,
  * cancer,
  * C.O.P.D.,
  * metabolic syndrome,
  * overweight,
  * kidney failure,
  * heart disease,
  * osteoporosis.
* Antibiotic treatment in the last 4 weeks
* Subjects on regular probiotic or prebiotic supplementation, unless they do 2 weeks of wash out.
* Subjects with intestinal disorders such as: IBD, IBS, celiac, colon cancer.
* Subjects after intestinal surgery.
* Use of medicines for lowering cholesterol (simvastatin), sugar control
* Pregnancy

Primary outcomes:
measure: To investigate the Glycemic Effect by drawing blood for glucose and insulin
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Suorasky Medical Center
Study officials:
affiliation: Suorasky Medical Center
name: Nachum Vaisman, Prof'
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00133562: HIAS II - Study of Nutritional Supplementation in Hospitalized Children With Persistent Diarrhea or Malnutrition
Official title: Prospective Double Blind Randomized Clinical Trial of Alanyl-Glutamine or Glycine in Hospitalized Children With Persistent Diarrhea or Malnutrition.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diarrhea, Malnutrition
Other Nutritional Deficiencies
Keywords: Malnutrition, pediatric, Brazil, alanyl-glutamine
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2005-08-23
Enrollment: 108
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the effect of 7 days supplementation of alanyl-glutatime or glycine on the damaged intestinal barrier function on day 8 in children with persistent diarrhea or malnutrition.

Detailed description: The purpose of this study is to determine the effect of 7 days supplementation of alanyl-glutamine or glycine on the damaged intestinal barrier function, measured by lactulose/mannitol test on day 8, in children with persistent diarrhea or malnutrition; on diarrhea frequency and duration, weight gain, protein loss, intestinal inflammation, and lactoferrin excretion.

Eligibility criteria: Inclusion Criteria:

1. Children ages 3 to 36 months with a history of persistent diarrhea (3 or more unformed stools/day) for \>2 weeks or height-for-age Z-score (HAZ) less than negative 1, which is the median of HAZ score in children at HIAS.
2. Be an inpatient and willing to stay for 7 nights at HIAS.
3. Child´s parent or guardian must sign informed consent..

Exclusion Criteria:

1. Children exclusively breast-fed (Reason: The diet needs to be controlled in order to evaluate the study treatment effect)
2. Children who participated in the community study or any other study within the past two years (Reason: The children in the community study will have received glutamine.)
3. Children with suspected other illnesses as indicated by fever \>102º F at time of screening off antipyretics
4. Children with suspected systemic disease at the time of screening including but not limited to shock, meningitis, sepsis, pneumonia, tuberculosis, varicella
5. Severe malnutrition defined as HAZ \<-3 or WAZ \<-3.5 or any child weighing \<10 lbs. (4.5 kg) or any child with a weight-to-height ratio \<60% of the NCHS age adjusted norm.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: Richard L Guerrant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01953562: Positioning and the Spontaneous Breathing Test in Neonates
Official title: Evaluation of the Influence of Positioning and Time Duration on the Spontaneous Breathing Test in Neonates
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spontaneous Breathing Test
Infants
NICU
Keywords: infants
NICU
intubated
ventilator
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 0
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intubated infants who qualify for the routine spontaneous breathing test.

Brief summary: The spontaneous breathing test (SBT) is routinely performed on all intubated patients in the NICU who are potential candidates for extubation from mechanical ventilatory support. For all parents who consent, the routine SBT will be performed on all infants. In addition to the routine SBT the following will occur:

1. work of breathing indices: obtained non-invasively through respiratory inductive plethysmography (RIP).
2. Performing the SBT in the prone position, in addition to the routine position (supine).


Eligibility criteria: Inclusion Criteria:

* Infants who qualify for SBT as part of their normal care

Exclusion Criteria:

* Previous history of abdominal or chest surgery (i.e. chest tube, PDA ligation, surgical NEC)
* Congenital malformation of the chest of abdomen
* Neuromuscular disorder
* Current medications affecting neuromuscular tone (ex morphine)
* Unable to be positioned either prone or supine as determined by the attending neonatologist.

Primary outcomes:
measure: Effect of prone vs supine positioning on whether an infant receives a passing score on the SBT test
timeFrame: 30 minutes
Secondary outcomes:
measure: WOB indices during SBT
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Christiana Care Health Services
name: Robert Locke, DO, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05255562: Comparison of Combined Serratus Anterior Plane Block and Thoracic Paravertebral Block
Official title: Comparison of the Effects of Ultrasound-Guided Combined Serratus Anterior Plane Block and Thoracic Paravertebral Block on Postoperative Acute Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Serratus Anterior Plane Block
Thoracic Paravertebral Block
Multimodal Analgesia
Thoracic Surgery, Video-Assisted
Lead sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-02-24
Enrollment: 60
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: Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block (SAPB), and erector spinae plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB and SAPB are some of them. There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, a local anesthetic agent is given under the serratus anterior muscle. In the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the serratus anterior muscle. Since it is done by entering from the same point in two applications, it is possible to perform these two applications at the same time with a single needle entry. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of DSAPB and SSAPB, as in the multimodal analgesia method. This study seeks to evaluate the effect of TPVB and combined SAPB (CSAPB) after VATS.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* ASA physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective video-assisted thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* Chronic opioid or analgesic use

Primary outcomes:
measure: Pain Scores
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Morphine Consumption
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Kecioren
country: Turkey
facility: Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
state: Ankara
Study officials:
affiliation: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
name: Musa Zengin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06689462: Appraisal of the Modified Cancer Cachexia Index in Locally Advanced Gastric Cancer Patients Undergoing Neoadjuvant Chemotherapy
Official title: Appraisal of the Modified Cancer Cachexia Index in Locally Advanced Gastric Cancer Patients Undergoing Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Neoadjuvant Chemotherapy
Computed Tomography
Random Forest Model
Keywords: Cancer cachexia index
Locally Advanced Gastric Cancer
Neoadjuvant chemotherapy
Adjuvant chemotherapy
Survival
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with locally advanced gastric cancer (cT2-4NanyM0)

Brief summary: In this study, consecutive 600 patients with LAGC(cT2-4NanyM0) who underwent NACT between Jan. 2010 and Jun. 2022 were identified from two tertiary hospitals. The mCXI was constructed based on Random Forest model, calculated as (post-NACT L3 subcutaneous adipose tissue area \[SAT\])×(post-NACT serum albumin \[ALB\])/(post-NACT platelet count \[PLT\]). Patients were categorized into two subgroups: mCXI-low and mCXI-high. mCXI is associated with the overall prognosis in patients with locally advanced gastric cancer underwent neoadjuvant chemotherapy, is superior to traditional CXI, and may serve as a decision-making tool for guiding personalized postoperative adjuvant chemotherapy.

Detailed description: This is a multicenter retrospective cohort study

Eligibility criteria: Inclusion Criteria:

* (1) locally advanced gastric cancer (cT2-4NxM0) with clinical staging before neoadjuvant chemotherapy, (2) no history of other malignant tumors, (3) no evidence of distant metastasis or invasion of adjacent organs, and (4) patients who underwent radical gastrectomy following neoadjuvant chemotherapy.

Exclusion Criteria:

* (1) history of gastric surgery; (2) acute cardiovascular disease (such as cerebrovascular or coronary artery injury) within the past three months; (3) emergency surgery; (4) active infection or severe systemic immunodeficiency; and (5) incomplete serological, computed tomography, or anthropometric data.

Primary outcomes:
measure: 3-year overall survival
timeFrame: 3 years or 36 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chang-Ming Huang, M.D. FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01428362: VI-1121 for the Treatment Alzheimer's Disease
Official title: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Safety, Tolerability and Efficacy of VI-1121 in Subjects With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: donepezil
VI-1121
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2011-09-05
Enrollment: 61
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and effective as a daily treatment for Alzheimer's disease that is worsening despite current treatment.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Alzheimer's disease
* CT or MRI within 2 years prior to study
* stable dose of current Alzheimer's treatment for at least 3 months

Exclusion Criteria:

* advanced, severe, progressive or unstable disease
* history of cerebrovascular disease or myocardial infarction within 6 months

Primary outcomes:
measure: The primary efficacy variable is the change in Alzheimer's Disease Assessment-Cognitive Subscale (ADAS-Cog) score from baseline to Week 12 of each treatment period.
timeFrame: 12 weeks
Secondary outcomes:
measure: The secondary efficacy endpoint is the mean change in Mini-Mental State Examination (MMSE) score from baseline to Week 12 of each treatment period.
timeFrame: 12 weeks
measure: Percentage of subjects who achieve 3-point improvement in ADAS-Cog score from baseline to Week 12 of each treatment period.
timeFrame: 12 Weeks
measure: Change in Clinician's Interview Based Impression of Change Plus Caregiver's Input (CIBIC-plus) score from baseline to Week 12 of each treatment period
timeFrame: 12 Weeks
measure: Mean change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score from baseline to Weeks 4, 8, and 12 of each treatment period
timeFrame: 4, 8, and 12 Weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Sunrise
country: United States
state: Florida
city: Louisville
country: United States
state: Kentucky
city: Las Vegas
country: United States
state: Nevada
city: Toms River
country: United States
state: New Jersey
city: New Windsor
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Plano
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT04872062: Monitoring of Patients With Chronic Respiratory Failure Treated With Non-invasive Home Ventilation: Contribution of New Monitoring Tools
Official title: Monitoring of Patients With Chronic Respiratory Failure Traeted With Non-invasive Home Ventilation: Contribution of New Monitoring Tools
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hypercapnic Respiratory Failure
Keywords: chronic hypercapnic respiratory failure
non-invasive ventilation
standardized NIV reading grid
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with chronic hypercapnic respiratory failure, treated with NIV at home, followed at the CHRU of Nancy in the UMA department between 11/01/2020 and 05/30/2021

Brief summary: Single-center retrospective study conducted on a population of patients with chronic hypercapnic respiratory failure treated by non-invasive ventilation at home, followed at the CHRU of Nancy. The objective is to assess the contribution of reading the NIV card with a standardized grid in their follow-up. The main objective is to assess the inter-observer agreement of a standardized NIV card reading grid, the secondary objective is to compare the results of NIV card reading between the usual NIV card reading method in the service and this same method completed by the addition of the standardized reading grid. The hypothesis is that the use of a standardized NIV card reading grid improves patient follow-up by standardizing their care.


Eligibility criteria: Inclusion Criteria:

* Major patients
* Patients with chronic hypercapnic respiratory failure with a validated indication of long-term NIV
* Follow-up at the CHRU of Nancy at "Unité de Médecine Ambulatoire" (UMA) department between 11/01/2020 and 05/30/2021

Exclusion Criteria:

* Data not usable / missing
* Tracheal ventilation
* Patients' opposition to the use of their data for the purposes of this research

Primary outcomes:
measure: Agreement of responses to a standardized NIV reading grid between 2 observers
timeFrame: Day 0
Secondary outcomes:
measure: Comparison of the results between two observers between the method of reading NIV card usually performed in the department and this same method supplemented with a standardized NIV reading grid
timeFrame: Day 0
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy - Site de Brabois
Study officials:
affiliation: CentraHNF
name: Julien Soler
role: STUDY_DIRECTOR
References:
Clinical trial NCT01878162: Work Injury Prevention in Law Enforcement Officials
Official title: Effectiveness of an Exercise-based Work Injury Prevention Program in Law Enforcement Officials
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Exercise
Keywords: Prevention
Wellness
Occupation
Work
Law Enforcement
Exercise
Lead sponsor: University of the Pacific
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Law enforcement officials (LEOs) demonstrate an elevated risk for occupational injury. The effectiveness of exercise-based work injury prevention programs (WIPPs) to reduce the risk and costs associated with occupational injury has yet to be tested rigorously in LEOs. The accuracy of existing field tests of physical functioning to predict occupational injuries and related expenses remains unclear. The objectives of this study are to: (i) determine the effect of an exercise-based WIPP on occupational wellness and productivity in a cohort of LEOs, and (ii) to determine the accuracy of 2 common field assessments of physical function to predict lost work productivity and related expenses in a cohort of LEOs.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60 years
* Working full duty as a law enforcement official

Exclusion Criteria:

* Current history of pathology or symptoms that preclude exercise
* Medical or rehabilitative treatment for a work-related injury within the past year prior to enrollment in this study

Primary outcomes:
measure: Number of Work Injury Claims During the Study Period
timeFrame: One time, at one year following enrollment into the study
measure: Medical Expenditures Related to Work Injury Claims During the Study Period
timeFrame: One time, at one year following enrollment into the study
measure: Number of Missed Work Days Due to Illness or Injury
timeFrame: One time, at one year following enrollment into the study
measure: Work Productivity and Activity Impairment Questionnaire - General Health Subscale
timeFrame: Weekly, up to one year following enrollment into the study
Secondary outcomes:
measure: Functional Movement Screen
timeFrame: One time, at 3 months following enrollment into the study
measure: Star Balance Excursion Test
timeFrame: One time, at 3 months following enrollment into the study
Other outcomes:
Locations:
city: Chico
country: United States
facility: Butte Premier Physical Therapy
state: California
city: Davis
country: United States
facility: Physical Edge
state: California
city: Lodi
country: United States
facility: PUMP Institute
state: California
city: Lodi
country: United States
facility: Lodi Physical Therapy
state: California
city: Stockton
country: United States
facility: University of the Pacific
state: California
Study officials:
affiliation: University of the Pacific
name: Todd E Davenport, PT, DPT, OCS
role: PRINCIPAL_INVESTIGATOR
References: