louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06764407: The Effect of Music on Postoperative Anxiety
Official title: The Effect of Patient Preferred Music on Postoperative Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Postoperative
Quality of Recovery
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 80
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: In this study, it is planned to learned the effect of listening to the music preferred by the patient on postoperative anxiety.

Detailed description: Preoperative anxiety can be detected via structured and standardized screening by the State-Trait Anxiety Inventory (STAI) I and II. 80 patients scheduled for total knee arthroplasty surgery for will be included in our study. Preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into two groups as listening patient preferential music, and control. The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones.Secondary aim is to assess the effect of listening patient preferred music on Quality of recovery, postoperative pain, MCID (minimal clinically important diffirence), patient and surgeon satisfaction.

Eligibility criteria: Inclusion Criteria:

* Undergo Total Knee Arthroplasty Under Spinal Anesthesia

Exclusion Criteria:

* Poor vision
* Significant hearing loss
* Dementia
* Active opioid use
* Regular use of anxiolytics or discontinuation of them on the day of surgery
* Unwillingness to participate in the study
* Unwillingness to listening to music

Primary outcomes:
measure: Spielberg State-Trait Anxiety Inventory (STAI) score
timeFrame: Preoperative 1st hour and Postoperative 4th hour
Secondary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: Postoperative 4th, 12th and 24th hours
measure: The quality of postoperative functional recovery (QoR-15) score
timeFrame: Preoperative 1st hour and Postoperative 24th hour
measure: Patient satisfaction score
timeFrame: Postoperative 24th hour
measure: MCID of STAI score
timeFrame: 24 hour
measure: MCID of QoR-15 score
timeFrame: 24 hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References:
citation: Kavak Akelma F, Altinsoy S, Arslan MT, Ergil J. Effect of favorite music on postoperative anxiety and pain. Anaesthesist. 2020 Mar;69(3):198-204. doi: 10.1007/s00101-020-00731-8. Epub 2020 Feb 11.
citation: Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
Clinical trial NCT05392907: Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study
Official title: Forensic-medical Aspects of Lower Limb Prosthetics: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Subjects with a unilateral lower limb amputation either trans-femural or trans-tibial
* Age:18-65 years old

Brief summary: The study investigated the perceived-mobility of patients with unilateral lower limb amputations by means of patient-reported outcome measures (PROMs). Such aspect may play an important role in evaluating the patient impairment and addressing forensic-medical issues. However, to this concern, the use of PROMs has not been extensively investigated yet. Among the validated PROMs, the study assessed self-perceived mobility and quality of life by administering the Trinity Amputation Prosthetic Evaluation Survey (TAPES) and the more recent Prosthetic Mobility Questionnaire (PMQ). The aim of this observational study was to improve the estimation of the physical and psychological impairment caused by the amputation, focusing on the impact of the limb loss on social participation, quality of life and daily living activities.


Eligibility criteria: Inclusion Criteria:

* Subjects aged between 18 and 65 years
* Unilateral trans-femural or trans-tibial amputation
* Experienced prosthesis users (at least two years)
* Subjects that provided written informed consent to study participation and data publication

Exclusion Criteria:

* Severe comorbidities
* Psychological impairment
* Pregnancy
* Patient not collaborative

Primary outcomes:
measure: Questionnaire: Trinity Amputation Prosthesis Experience Scale (TAPES)
timeFrame: After recruitment, patient anamnesis is performed by an expert clinician. Then, the TAPES questionnaire is administered. The completion time is about 15 minutes
measure: Score of the Prosthetic Mobility Questionnaire (PMQ)
timeFrame: After completion of TAPES questionnaire, PMQ is administered. The completion time is about 3 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Budrio
country: Italy
facility: Centro Protesi Inail
state: Bologna
Study officials:
References:
Clinical trial NCT03480607: Dexmedetomidine as Adjuvant for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block for Cleft Lip Repair
Official title: Comparative Evaluation of Dexamethasone and Dexmedetomidine as Adjuvants for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block in Infants for Cleft Lip Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cleft Lip
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 44
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assess the efﬁcacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for infra-orbital nerve block in infants undergoing cleft lip surgery.

Detailed description: Regarding patient registry; A prior G power analysis was done. Using the results obtained from previous studies and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 20 patients per group was calculated. A drop out 10% of cases is expected, so; 22 cases per group will be required.

Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by Shapiro test. Data will be presented as mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, unpaired t test will be used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.

Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologist (ASA) physical status I or II

Exclusion Criteria:

* known allergy to any of drugs used
* coagulopathy
* any wound or infection related to puncture site
* major illness
* failure to gain consent of parents.

Primary outcomes:
measure: Postoperative FLACC scale
timeFrame: for 24 hours after surgery
measure: Postoperative sedation score
timeFrame: for 4 hours after surgery
Secondary outcomes:
measure: Heart rate
timeFrame: For 4 hours after induction
measure: Systolic blood pressure
timeFrame: For 4 hours after induction
measure: Postoperative nausea
timeFrame: for 24 hours after surgery
measure: Haematoma formation after surgery
timeFrame: for 24 hours after surgery
measure: Postoperative vomiting
timeFrame: for 24 hours after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University Childeren Hospital
state: DK
Study officials:
affiliation: Mansoura University
name: Enas Abd el Motlb, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00605007: Study on COPD Corticosteroid-induced Hyperglycemia on Clinical Outcome in Patients With COPD
Official title: The Impact of Corticosteroid-induced Hyperglycemia on Clinical Outcome (Length of Stay, Disposition, APACHE Score, Need for Ventilatory Support and ICU Admission, Mortality) in Patients With COPD Exacerbation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD
Diabetes
Respiratory Disorders
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-01-30
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted with COPD exacerbation at Atlanta Medical Center and Grady Memorial Hospital

Brief summary: Hyperglycemia is a common complication of corticosteroid (cortisone) therapy. It is estimated that more than a third of patients with chronic pulmonary disease (COPD) exacerbation (16). Despite its frequency, the impact of corticosteroid-induced diabetes on clinical outcome and mortality is not known. A computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966 to 2006 provided very little information on the prevalence and outcome of corticosteroid-induced diabetes in patients with COPD. Therefore, the present study aims to evaluate the impact of corticosteroid-induced diabetes on clinical outcome in patients with COPD exacerbation. We will perform a retrospective chart review of all patients admitted to the hospital with COPD exacerbation from 1/01/05 to 06/30/06 at Grady Memorial Hospital. Medical records of all patients with COPD exacerbation treated with corticosteroids will be analyzed. Data on demographics, laboratory values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.

Detailed description: Hypotheses:

We hypothesize that COPD patients with corticosteroid-induced hyperglycemia experience higher morbidity (infections, ventilator associated pneumonia, length of stay, acute renal failure) and mortality compared to COPD patients with normal glucose levels.

Specific Aim:

To determine the impact of corticosteroid-induced hyperglycemia on clinical outcome (length of stay, disposition, APACHE score, need for ventilatory support and ICU admission, mortality) in patients with COPD exacerbation.

Eligibility criteria: Inclusion Criteria: Patients admitted with COPD exacerbation

Primary outcomes:
measure: The primary outcome of the study is to determine the mortality rate of COPD patients with corticosteroid-induce hyperglycemia.
timeFrame: once all charts have been reviews
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University SOM
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06572007: The Impact Of Fascia Thickness on Chronic Low Back Pain
Official title: Relationships of Fascia Thickness With Pain, Flexibility, Disability and Depression in Individuals With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Disability Physical
Pain, Chronic
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Getting a diagnosis of low back pain

Brief summary: This study aimed to investigate the impact of lumbar perimuscular and subcutaneous zone thickness on pain, functionality, disability, and depression in individuals with chronic low back pain (CLBP).

Detailed description: This study investigates the role of the thoracolumbar fascia (TLF) in chronic low back pain (CLBP) persisting for more than one year. Specifically, the researchers aim to examine the relationships between various factors in individuals with CLBP, including the thickness of the perimuscular and subcutaneous regions in the lumbar and hamstring regions. The relationship with functional tests of the lower back and lower limbs will also be analysed. In addition, the intensity of the pain experienced by the participants, the extent to which the pain restricts their daily activities, and depression scores will be assessed. Through this analysis, the researchers aim to gain a deeper understanding of TLF's involvement in CLBP and its impact on the overall well-being of affected individuals.

Eligibility criteria: Inclusion Criteria:

* The absence of LBP in the last 12 months,
* A body mass index (BMI) of 18.5 to 30,
* An age between 30 and 50 years.

Exclusion Criteria:

* History of musculoskeletal diseases,
* a history of back and lower limb surgery,
* the use of anti-inflammatory drugs and steroids

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: baseline
measure: Straight Leg Raise Test (SLR)
timeFrame: baseline
measure: Lumbar Extensor Shortening Assessment
timeFrame: baseline
Secondary outcomes:
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: baseline
measure: Beck Depression Inventory
timeFrame: baseline
Other outcomes:
Locations:
city: Tuzla
country: Turkey
facility: Emine Atıcı
state: İstanbul
city: Istanbul
country: Turkey
facility: Istanbul Okan University
Study officials:
affiliation: Okan University
name: Emine Atıcı
role: STUDY_DIRECTOR
References:
Clinical trial NCT02386007: Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Gastric Inflammation Patients
Official title: A Double-blind, Multicenter, Randomized Phase 2a Study to Evaluate Optimum Dosage and Stability of DW-3101 in Korean Patients With Gastric Inflammation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute and Chronic Gastric Inflammation Patients
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
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 find optimum dosage of DW-3101 by evaluating efficacy and safety of each dosage group in Korean patients with acute and chronic gastric inflammation.


Eligibility criteria: Inclusion Criteria:

* Adult males/females aged 20\~75 years
* Patients detected over 1 erosion who diagnosed as acute or chronic gastric inflammation by gastrscopy in 7days before administration of experimental agents
* Subjects who voluntarily agree to participate in this clinical test with written consent

Exclusion Criteria:

* Patients impossible gastroscopy
* In case accompanied with gastric ulcer(scar excepted) or reflux esophagitis
* Patients who had stomach or esophagus surgery to inhibit gastric acid secretion (tresis or appendicectomy surgery excluded)
* Patients with malignant tumor on digestive organ
* Patients with blood clot(cerebral thrombosis, myocardial infarction, septic thrombophlebitis) and who have antithrombotic agents (eg. warfarin)

Primary outcomes:
measure: The change of gastric erosion score
timeFrame: 14day±3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00862407: Impact of Pulsatile Cardio-Pulmonary Bypass (CPB) on Vital Organ Recovery
Official title: Impact of Pulsatile CPB on Vital Organ Recovery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardio-Pulmonary Bypass
Keywords: Cardiopulmonary bypass
Non-pulsatile perfusion
Pulsatile perfusion
plasma proteins
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Penn State University
First posted: 2009-03-16
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 children (150 per perfusion system) ages 1 year to \< 18 years requiring CPB for cardiac surgery.

Brief summary: This research study is about the effect heart-lung bypass procedures have on the vital organs (brain, heart, lungs, and kidneys) during open-heart surgery in pediatric patients. There are two types of heart pumps used in surgery requiring heart-lung bypass; one pumps the blood continuously through the body and the other pumps the blood with repeated pulses. Both pumps are approved for clinical use by the FDA. Although 90% of institutions still use non-pulsatile flow, some studies show there may be benefits to using pulsatile flow during surgery.

The investigators want to learn whether the vital organs (brain, heart, lungs, and kidneys) respond differently to one method than they do to the other. Approximately 300 children will take part in this research at the Hershey Medical Center.


Eligibility criteria: Inclusion Criteria:

* Patients recruited from Penn State Children's Hospital undergoing cardiac surgery with cardiopulmonary bypass.

Exclusion Criteria:

* Patients older than 17 years will be excluded.

Primary outcomes:
measure: Changes in plasma proteins
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03610607: Intense Education of Periodontal Health Maintenance
Official title: Shifting the Ratio of S. Cristatus vs. P. Gingivalis in Periodontitis Patients by Intense Education of Periodontal Health Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronical Periodontitis, Ratio of P. Gingivalis and S. Cristatus
Lead sponsor: Meharry Medical College
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2018-08-01
Enrollment: 270
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators hypothesize that good oral hygiene may inhibit P. gingivalis, a keystone periodontal pathogen, entering mature dental plaque, which leads to a higher ratio of S. cristatus and P. gingivalis. Investigators will educate and train periodontitis patients following periodontal therapy to maintain periodontal health. Initial and intense education of periodontal health maintenance will be provided and the ratio of S. cristatus and P. gingivalis in dental plaques will be compared and analyzed for correlation between patient's execution of periodontal health maintenance and education tools or the ratio of S. cristatus and P. gingivalis.

Detailed description: The periodontal health maintenance will be evaluated by plaque index, periodontal pocket, and gingival inflammation status. Participants will be assigned into two groups after the second dentist visit based on their execution of periodontal health maintenance. Participants whose number of P. gingivalis is unchanged or higher compared to that found at baseline will be considered poor maintenance. Those not having maintained a good dental hygiene will further be randomly assigned to two groups. One group will be given more intense oral health education, while the other one will receive the same education as post therapy. The result of intensive education and a shift in ratio of S. cristatus and P. gingivalis will then be measured for both groups at the third dentist visit (9 months after initial periodontal treatment) and the effectiveness of the intervention will be tested at this stage.

Eligibility criteria: Inclusion Criteria:

* Subjects should have \> 16 teeth, 2 or more interproximal sites with CAL \>4 mm and 2 or more with pocket depth \>5 mm.

Exclusion Criteria:

* No scaling and root planing within the previous year or periodontal surgeries in the previous five years.

Primary outcomes:
measure: Improvement of periodontal condition
timeFrame: 9 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
Study officials:
References:
Clinical trial NCT03505307: Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)
Official title: Lynparza Tablets 100mg, 150mg Clinical Experience Investigation (All Case Investigation) in Patients With Platinum-sensitive Relapsed Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-04-23
Enrollment: 846
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with LYNPARZA for ovarian cancer which is the indication of the drug

Brief summary: \[Objectives\] Objectives include following to capture safety and efficacy of LYNPARZA in actual clinical use.

1. ADR development in actual clinical use
2. Factors which may affect safety and efficacy
3. ADRs not expected from "Precautions for Use"

Detailed description: The objective of the Clinical Experience Investigation (CEI) is to collect following data to characterise safety and efficacy of LYMPARZA Tablets 100mg and 150mg (LYMPARZA) in usual post-marketing use.

1. Development of adverse drug reactions (ADRs)
2. Factors which may affect safety and efficacy of LYMPARZA
3. Development of adverse drug reactions (ADRs) unexpected from "Precautions for Use" of the LYMPARZA JPI

Eligibility criteria: Inclusion Criteria:

* Maintenance treatment for patients with recurrent ovarian cancer, who are sensitive to platinum based chemotherapy

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of ADRs regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment
timeFrame: from baseline to 1 year
measure: Factors which may impact incidence of ADRs related to LYMPARZA during the observation period, analysed by patient demographic characteristics
timeFrame: from baseline to 1 year
measure: Incidence of ADRs not expected from "Precautions for Use" of LYNPARZA JPI
timeFrame: from baseline to 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca KK
name: Toshimitsu Tokimoto
role: STUDY_DIRECTOR
References: