louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04604769: Perceived Stress Among ICU Medical Staff During COVID-19 Crisis
Official title: Perceived Stress and Needs Among Medical Staff in ICU During COVID-19 Crisis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
Nurse's Role
Professional Stress
Keywords: coronavirus
covid-19
pandemia
professional stress
burnout
nursing
intensive care units (ICU)
infection
work organization
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nurses and doctors working in intensive care units before and during the COVID pandemic.

Brief summary: The objective of this study is to compare psychological distress and needs of nurses in ICU before and during coronavirus pandemic.

Detailed description: Well-being of caregivers and stress management in intensive care units are essential keys to an adequate quality of care, especially during the anxious context of coronavirus pandemic. Taking care of numerous patients, the increasing work and mental charges, facing death, the need of material and changes in work organization are all elements that can influence stress among medical workers. Considering real causes of stress and what are the needs of the medical team is fundamental for developing concrete actions to ease the workloads. A few studies were conducted in China on psychological distress of medical staff during COVID-19. According to these few studies about psychological distress in ICU, investigators think that stress scores during COVID-19 could be increased among nurses during pandemic. The second hypothesis is that causes of stress would be not so different from normal care but could be amplified by the actual situation. One point to take into consideration is that most of the studies were conducted in China and medical policy and hospital organization are different in Belgium. The objective of the study is to compare psychological distress and needs of nurses in ICU before and during coronavirus pandemic.

Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years old
* working in ICU for at least November 2019
* working in ICU regularly since March 2020
* Medical and paramedical professionals
* Working in direct contact with COVID patients

Exclusion Criteria:

* Medical professionals from others departments
* Internship students
* External volunteers for COVID
* Non front-line nurses

Primary outcomes:
measure: stress at work
timeFrame: change from baseline at one year
measure: stress in a medical unit
timeFrame: change from baseline at one year
Secondary outcomes:
measure: hobby activities
timeFrame: change from baseline at one year
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University of Liège
state: Province De Liège
Study officials:
affiliation: Université de Liège
name: Anne-Sophie Nyssen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03074968: Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients
Official title: Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation Complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 142
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is designed to examine the effect of benzydamine hydrochloride to postoperative sore throat in pediatric patients. We will spray benzydmaine hydrochloride or normal saline at oral cavity and the tip of endotracheal tube, than compare the prevalence of postoperative sore throat using smartphone application in pediatric patients.

Detailed description: 1. postoperative sore throat incidence (over 2) 1; no, 2;mild, 3;moderate, 4;severe
2. scoring of pain with smartphone application (kids pain scale)
3. incidence of use of rescue pain killer

Eligibility criteria: Inclusion Criteria:

* general anesthesia
* intubation require

Exclusion Criteria:

* recent upper airway infection
* could not express the pain

Primary outcomes:
measure: pain
timeFrame: 30 minutes in postanesthetic care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
affiliation: Seoul National University
name: Hee-Soo Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yhim HB, Yoon SH, Jang YE, Lee JH, Kim EH, Kim JT, Kim HS. Effects of benzydamine hydrochloride on postoperative sore throat after extubation in children: a randomized controlled trial. BMC Anesthesiol. 2020 Apr 4;20(1):77. doi: 10.1186/s12871-020-00995-y.
Clinical trial NCT01427868: Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
Official title: An Open-label, Phase I Study in Healthy Male Subjects to Compare the Pharmacokinetics of LB80331 and LB80317, Metabolites of LB80380, After a Single Oral Administration of LB80380 Free Base 150 mg (60 mg + 90 mg) Tablet or LB80380 Maleate Tablet 183 mg (150 mg as a Free Base)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B
Keywords: LB80380
bioequivalence
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Male with good health
* 20 to 45 years of age at screening
* Body weight ±20% of ideal body weight
* Willingness and ability to comply with study procedures and communicate with investigators
* Provided written consent voluntarily after informed of all the pertinent aspects of the trial

Exclusion Criteria:

* Clinically significant abnormality on medical interview, physical examination, electrocardiogram or clinical laboratory evaluations
* Clinically significant acute or chronic medical conditions
* Use of prescriptive medicine within 14 days, or over-the-counter drug within 7 days before the first day of drug administration
* Participation in clinical trial within 3 months before the first day of drug administration
* Alcohol abuse
* Habitual smoker
* Habitual user of herbal medicine
* Use of grapefruit-containing food or grapefruit juice during the study period
* Positive drug abuse test and Positive HBs-antigen, HCV-antibody, or HIV-antibody test

Primary outcomes:
measure: AUC
timeFrame: up to 144 hours
measure: Cmax
timeFrame: up to 144 hours
Secondary outcomes:
measure: Number of Participants with Adverse Events and Number of Adverse Events as a Measure of Safety and tolerability
timeFrame: up to 7 days
measure: Profile of Pharmacokinetics
timeFrame: up to 144 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Center, Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Wooseong Huh, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung JA, Kim SR, Kim TE, Kim JR, Lee SY, Huh W, Ko JW. Pharmacokinetic comparison of the maleate and free base formulations of LB80380, a novel nucleotide analog, in healthy male volunteers. Int J Clin Pharmacol Ther. 2012 Sep;50(9):657-64. doi: 10.5414/cp201716.
Clinical trial NCT00051168: A Long-term Safety Study of Once-daily Travatan
Official title: A Long-term Safety Study of Once-daily TRAVATAN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Open-angle
Ocular Hypertension
Keywords: Glaucoma
POAG
OAG
OHT
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-01-07
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.


Eligibility criteria: Adult patients of any race and either sex with chronic angle-closure glaucoma.

Primary outcomes:
measure: Mean Intraocular Pressure
timeFrame: At 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Europe
state: Texas
Study officials:
References:
Clinical trial NCT02762968: The Effects of Probiotic and HMB Supplementation on Immune and Digestive Function in Special Operations Soldiers
Official title: The Effects of 8-weeks of Probiotic and HMB Supplementation on Immune and Digestive Function in Special Operations Soldiers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Military Training
Lead sponsor: Metabolic Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Central Florida
First posted: 2016-05-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study will determine whether acute ingestion of a probiotic combined with beta-hydroxy-beta-methylbutyrate (HMB) can enhance immune and digestive function in soldiers during 8-weeks of advanced infantry training.

Detailed description: Up to sixty soldiers from an elite infantry unit will perform a parallel design investigation. Soldiers will be randomly assigned to one of four groups. Group 1 will consume the probiotic plus HMB, group 2 will consume HMB only, group 3 will consume only the probiotic, and group 4 will consume only placebo. All four groups will be garrisoned together, eat the same meals, and perform the same activity. All groups will be tested before as well as after an 8-week advanced infantry training program. During each testing session resting blood samples will be obtained to assess cytokine, inflammatory, and muscle damage markers. Additionally, questionnaires will be used to determine digestive health. Anthropometric, performance, and muscle volume measures will also be assessed prior to and immediately following the supplementation and training protocol.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Member of the same unit of the IDF

Exclusion Criteria:

* Current use of dietary supplements
* Current chronic use of medications

Primary outcomes:
measure: Maintenance of Immune function
timeFrame: 8 weeks
Secondary outcomes:
measure: Maintenance of Digestive Function
timeFrame: 8 Weeks
measure: Maintenance of Muscle Volume
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Beersheva
country: Israel
facility: Israel
Study officials:
affiliation: University of Cenral Florida
name: Jay R Hoffman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01067768: Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication
Official title: Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Urinary Tract; Accessory
Keywords: Urinary Tract Infections
Catheter-associated urinary tract infections
Prevention and control
Controlled clinical trial
Lead sponsor: Hospital Pablo Tobón Uribe
Sponsor class: OTHER
First posted: 2010-02-12
Enrollment: 1209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the daily nurse review of the indication of the urinary catheter compared to the everyday care of the working staff is effective to reduce the rate of catheter-associated urinary tract infection in adults hospitalized.

Detailed description: Healthcare-associated infection (HAI)in hospitalized patients are very frequent, especially the catheter-associated urinary tract infection, which prolongs the hospital stay and costs, and is about 3 times more likely to die during hospitalization than patients not infected.

The measures of aseptic insertion and closed systems of collection, as well as the rational use of the probe reduce the risk for infection.

A checklist that contains the agreed indications of catheter, related to obstruction, incontinence, skin lesions in sacral region, monitoring or surgical procedures allows the daily review of the indication of the probe. If the patient doesn´t meet at least one of the criteria, should be recommended the withdrawal of the catheter.

Eligibility criteria: Inclusion Criteria:

* Inpatient with a permanent urinary catheter (balloon catheter)
* Urinary catheter placed in the hospitalization (previous day) or at admission

Exclusion Criteria:

* Urinary tract infection diagnosis at time of the insertion
* Spinal cord injury or neurogenic bladder at admission

Primary outcomes:
measure: Rate of Catheter-associated Urinary Tract Infection
timeFrame: Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)
Secondary outcomes:
measure: Catheter Days
timeFrame: withdrawal of the catheter
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
Study officials:
affiliation: Hospital Pablo Tobón Uribe
name: María V Restrepo, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06250868: TRK-3 Performance of Pachymetry
Official title: TRK-3 Agreement and Precision of Pachymetry Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2024-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have healthy cornea

Brief summary: To evaluate the performance of a new tonometer.


Eligibility criteria: Inclusion Criteria:

1. Provide voluntary written consent for participation in the study.
2. Age at least 22 years old at the time of informed consent.

Exclusion Criteria:

1. Ocular condition that may affect the ability to perform corneal measurement (e.g., corneal perforation, bullous keratopathy, nystagmus)
2. Have or is suspected to have an ocular infection in either eye.
3. Otherwise considered unsuitable for the study by the investigator
4. Unable to tolerate ophthalmic testing.

Primary outcomes:
measure: Cornea thickness
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Topcon Healthcare Innovation Center
state: California
Study officials:
References:
Clinical trial NCT04306068: Plyometrics in the Ankle Stabilizing Muscles in Improving Balance in Ballerinas
Official title: Efficacy of an Intervention by Plyometrics in the Ankle Stabilizers in the Improvement of the Balance in Salsa Dancers From 18 to 25 Years. A Randomized Clinical Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Balance; Distorted
Keywords: Balance
Plyometrics
Dance
Stability
Injuries
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2020-03-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Balance is essential for successful dance performance. The effort of salsa dancers is given by the levels of stability, produced by the muscular activation of lower limbs.

The objective of the study is to assess the effectiveness of an intervention of plyometric exercises in the improvement of balance in salsa dancers from 18 to 25 years.

Randomized clinical study. 40 dancers will be randomized to the two study groups: experimental (application of plyometric exercise protocol) and control (without intervention). The treatment will last 5 weeks, with 2 weekly sessions of 25 minutes each. The dependent variables will be: equilibrium (measured with star excursion balance). The sample distribution will be calculated using the Kolmogorov-Smirnof test. The changes after each evaluation will be calculated with the t-student test. With an ANOVA of repeated measures, the intra and intersubject effect will be observed. The effect size will be obtained with Cohen's formula.

It is expected to see improvement in the stability of the ankle and the level of balance in the dancers.


Eligibility criteria: Inclusion Criteria:

* Dancers
* Female
* From 18 to 25 years
* With more than a year of dance practice
* And without musculoskeletal injury at the time of starting the study.

Exclusion Criteria:

* Subjects who do not attend all training sessions
* Pregnant women or intending to remain in state during the study period
* Have not signed the informed consent

Primary outcomes:
measure: Change from baseline stability after treatment and at month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Europea de Madrid
state: Comunity Of Madrid
Study officials:
References:
Clinical trial NCT01767168: Study to Test the Value of a Pain Modulation Test in Predicting Persistent Postoperative Pain After Breast Cancer Surgery
Official title: Trial of Diagnostic Accuracy for the Prediction of Persistent Postoperative Pain After Breast Cancer Surgery Using a Conditioned Pain Modulation Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Acute Pain
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2013-01-14
Enrollment: 200
Sex: FEMALE
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: women scheduled for any type of breast cancer surgery in a university hospital breast cancer center

Brief summary: The purpose of this study is to test the hypothesis that a preoperative test of pain modulation predicts persistent pain 4 months after breast cancer surgery. In addition, a risk score for the prediction of persistent pain will be developed from parameters available before surgery.


Eligibility criteria: Inclusion Criteria:

* age \>=18 years
* American Society of Anesthesiology functional status I-III
* able to read and understand the information sheet and give informed consent

Exclusion Criteria:

none

Primary outcomes:
measure: prevalence of pain at the site of surgery
timeFrame: 4 months postop
Secondary outcomes:
measure: acute pain
timeFrame: 24h
measure: subacute pain
timeFrame: 1 week
measure: prevalence of pain necessitating analgesics at the site of surgery
timeFrame: 4 months
measure: prevalence of pain at the site of surgery
timeFrame: 8 months
measure: prevalence of pain at the site of surgery
timeFrame: 12 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
affiliation: Dept of Anesthesiology, HUG
name: Benno Rehberg-Klug, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06001268: Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)
Official title: Support Through Remote Observation and Nutrition Guidance Program for Individuals With Pancreatic Cancer Undergoing Surgery (STRONG-PCS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Nutrition Support
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to assess the feasibility and participant satisfaction with the Support through Remote Observation and Nutrition Guidance program. The program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are undergoing surgery.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Diagnosis of pancreatic cancer
* Completed open pancreatic surgery (e.g., Whipple, distal/subtotal pancreatectomy, total pancreatectomy) for treatment at Moffitt Cancer Center
* Discharged on an oral diet
* Able to speak and read English or Spanish
* Able to provide informed consent

Exclusion Criteria:

* Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)

Primary outcomes:
measure: Recruitment Rate - Feasibility
timeFrame: Up to 48 months
measure: Retention Rate - Feasibility
timeFrame: at 8 weeks
measure: Data Collection - Feasibility
timeFrame: at 8 weeks
measure: Participant Satisfaction - Acceptability
timeFrame: at 8 weeks
measure: Participant Rating on Ease of Use the Mobile Application - Usability
timeFrame: at 8 weeks
Secondary outcomes:
measure: Malnutrition-Significant weight loss
timeFrame: 90 days
measure: Malnutrition - Low BMI
timeFrame: at Baseline, 30, 60 and 90 days
measure: Malnutrition - Low Skeletal Muscle Mass
timeFrame: At baseline, 30, 60 and 90 days
measure: Quality of Life
timeFrame: at Baseline, 4, 8 and 12 weeks
measure: Hospital Readmissions
timeFrame: 30, 60 and 90 days post-hospital discharge
measure: Malnutrition -Nutritional Status
timeFrame: at Baseline, 30, 60 and 90 days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Kea Turner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Pamela J Hodul, MD
role: PRINCIPAL_INVESTIGATOR
References: