louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05958238: The Effects of AR and VR Oral Care Training System on Oral Healthcare for Elderly in Eldercare Students
Official title: The Effects of Augmented Reality (AR) and Virtual Reality (VR) Oral Care Training System on Oral Healthcare for Elderly in Eldercare Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Elderly
Medical Education
Augmented Reality
Virtual Reality
Oral Hygiene
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to assess the effectiveness of an AR/VR oral care training system on the knowledge, attitudes, self-efficacy, and behavioral intentions of students majoring in geriatric care.

Detailed description: A randomized controlled trial design will be employed, students randomly assigned to either the experimental group or the control group. The experimental group will receive a total of two sessions of AR/VR oral care training, each lasting two hours, with the intervention taking place two weeks and four weeks after completing the pre-test questionnaire. The control group, on the other hand, will receive traditional oral care instruction for thirty minutes.

Each student collected the data by a self-administered questionnaire before and immediately after each intervention.

Linear regression in generalized estimating equations (GEE) compares the differences between both groups.

Eligibility criteria: Inclusion Criteria:

* Aged 18-30 years
* Students majoring in geriatric care
* Fooyin University of Technology

Exclusion Criteria:

* Transfer student

Primary outcomes:
measure: Oral care-related knowledge
timeFrame: Change from Baseline at 2-week after intervention
measure: Oral care-related knowledge
timeFrame: Change from Baseline at 4-week after intervention
measure: Attitude toward oral care
timeFrame: Change from Baseline at 2-week after intervention
measure: Attitude toward oral care
timeFrame: Change from Baseline at 4-week after intervention
measure: Self-efficacy of oral care
timeFrame: Change from Baseline at 2-week after intervention
measure: Self-efficacy of oral care
timeFrame: Change from Baseline at 4-week after intervention
measure: Intention to oral care behaviors
timeFrame: Change from Baseline at 2-week after intervention
measure: Intention to oral care behaviors
timeFrame: Change from Baseline at 4-week after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Kaohsiung Medical University, College of Dental Medicine, Department of Oral Hygiene
name: HSIAO- LING HUANG, Dr.PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01213108: Effects of the Örebro Prevention Program on Youth Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Youth Drinking
Keywords: Örebro prevention program
Youth drinking
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swedish National Institute of Public Health
name: Alcohol Research Council of the Swedish Alcohol Retailing Monopoly
First posted: 2010-10-01
Enrollment: 1752
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Örebro prevention program is a brief (6 x 30 minutes)program administered to parents of 13-16 year old youths in regular parental meetings. The program aims to encourage parents to maintain a restrictive attitude towards youth drinking throughout their children's teenage years, and thereby postpone and reduce youth drinking. A previous quasi-experimental study by the program developers showed a sustained alcohol-specific restrictivity among parents exposed to the program, and also a reduction on drinking measures among the youths of the exposed parents (Koutakis, Stattin \& Kerr, 2008). This study aims to investigate whether these effects are sustained also when the program has gone into wide dissemination in Sweden.


Eligibility criteria: Inclusion Criteria: Municipal schools in counties with local ÖPP program presenters, comprising grades 7-9, with at least two 7th grade classes in parallel, and with no previous experience of the Örebro prevention program.

-

Exclusion Criteria:

-

Primary outcomes:
measure: Self-reported drunkenness
timeFrame: 12 months
measure: Self-reported drunkenness
timeFrame: 30 months
Secondary outcomes:
measure: Self-reported alcohol consumption
timeFrame: 12 months
measure: Self-reported alcohol consumption
timeFrame: 30 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: STAD, Centre for Psychiatry Research Stockholm, Karolinska Institutet/Stockholm County Council Health Care Provision
Study officials:
affiliation: Centre for Psychiatry Research Stockholm, Karolinska Institutet/Stockholm County Council Health Care Provision
name: Maria C Bodin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bodin MC, Strandberg AK. The Orebro prevention programme revisited: a cluster-randomized effectiveness trial of programme effects on youth drinking. Addiction. 2011 Dec;106(12):2134-43. doi: 10.1111/j.1360-0443.2011.03540.x. Epub 2011 Sep 21.
Clinical trial NCT00372008: Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males
Official title: A Phase II Randomised, Two-Way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered-Dose (MD) Lotion Doses in Hypogonadal Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism
Lead sponsor: Acrux DDS Pty Ltd
Sponsor class: INDUSTRY
First posted: 2006-09-06
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this study will evaluate the efficacy and safety of this product.


Eligibility criteria: Inclusion Criteria:

* Hypogonadal males between 18-70 years old with qualifying general medical health

Exclusion Criteria:

* Disqualifying concurrent conditions or allergy/sensitivity to testosterone replacement therapy

Primary outcomes:
measure: Pharmacokinetic
Secondary outcomes:
measure: Safety and tolerability
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham
state: Alabama
city: La Mesa
country: United States
state: California
city: Torrance
country: United States
state: California
city: New Britain
country: United States
state: Connecticut
city: Ocala
country: United States
state: Florida
city: Shreveport
country: United States
state: Louisiana
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Acrux Ltd
name: Tina Soulis, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06287008: ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery
Official title: A Comparative Study on Outcomes of ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: robot-assisted kidney transplantation
ABO incompatible
biopsy-proven acute rejection
immunologically high-risk patients
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: study includes 210 patients who undergo ABOi-open kidney transplantation and 29 who undergo ABOi-robot assisted kidney transplantation

Brief summary: While robot-assisted kidney transplantation (RAKT) offers potential benefits such as minimal postoperative pain, better cosmesis, fewer wound infections, and shorter hospital stay, its efficacy in ABO-incompatible (ABO-i) KT compared to open KT (OKT) remains understudied. This study aims to compare ABO-i KT outcomes between RAKT and OKT.

The study utilized data from 29 ABO-i RAKT and 210 ABO-i OKT cases performed at Asan Medical Center from October 2020 to February 2023. Univariate and multivariate analyses were performed to evaluate factors associated with a composite of biopsy-proven acute rejection (BPAR), de novo donor-specific antibodies (DSA), and overall graft failure.


Eligibility criteria: Inclusion Criteria:

* Patient eligible for living donor ABO incompatible kidney transplantation
* Presenting an IsoAgglutinin immunoglobulin G titer (anti-A-B) between 1/8 and 1/128 before operation
* Patient older than 18 years and young than 80 years
* Patient able to sign an informed consent form

Exclusion Criteria:

* Patient with comorbidities or hypersensitivity that prevent desensitization protocols
* Women who are pregnant, or who may become pregnant or breastfeeding women
* Subjects under legal protection
* Subjects participating in another interventional research protocol or in an exclusion period from another interventional research protocolPatient affiliated with a social security scheme

Primary outcomes:
measure: Graft survival
timeFrame: 1 year post-operative
measure: renal function
timeFrame: 1 year post-operative
Secondary outcomes:
measure: . A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies
timeFrame: 1 year post-operative
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT04261608: A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China
Official title: A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Augmentation
Breast Reconstruction
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2020-02-10
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective chart review study where data will be collected from all eligible patients who consecutively underwent breast implant surgery with McGhan single lumen gel-filled Breast implants from 24 December 2015 to 31 December 2019.

Brief summary: This study is a retrospective chart review and entails review of medical records of patients enrolled in about 5 hospitals/clinics in China, and who have undergone breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019. The safety of McGhan breast implants (textured and smooth) will be evaluated based on occurrence of local complications including capsular contracture, malposition of implant, seroma/late seroma and anaplastic large cell lymphoma (ALCL).


Eligibility criteria: Inclusion Criteria:

* patients who underwent breast augmentation or reconstruction with McGhan breast implants between 24 December 2015 and 31 December 2019

Exclusion Criteria:

-

Primary outcomes:
measure: Number of participants who experienced adverse events
timeFrame: up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Lidu Plastic Surgery Hospital
state: Beijing
city: Beijing
country: China
facility: Plastic Surgery Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Sogood Medical Cosmetology Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Second People's Hospital of Guangdong Province
state: Guangdong
city: Changsha
country: China
facility: Changsha Yan Han Medical Plastic Hospital
state: Hunan
city: Changsha
country: China
facility: Hunan Yamei Medical Cosmetology Hospital
state: Hunan
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Jie Luan, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01487408: Special Survey for Type 1 or Type 2 Diabetic Patients
Official title: Special Survey for Type 1 or Type 2 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 1463
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 1 or type 2 diabetes.

Brief summary: This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia episodes under normal clinical practice for patients with type 1 or type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Patients with diabetes requiring insulin therapy

Exclusion Criteria:

* Patients who had not been treated more than 3 months at the same investigational site
* Patients who had treatment history of NovoRapid® (insulin aspart)

Primary outcomes:
measure: HbA1c (glycosylated haemoglobin)
Secondary outcomes:
measure: Incidence of servere hypoglycaemia
measure: Total dose of insulin (aspart/human insulin) infused subcutaneously
measure: Physical examination
measure: Adverse events
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03728608: Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination
Official title: Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: neonatal intensive care unit (NICU)
feeding tube contamination
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-11-02
Enrollment: 151
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination

Detailed description: Contaminated feeding tubes can occur in the neonatal intensive care unit (NICU) and have been associated with significant morbidity. Due to an immature immunologic systems, premature infants are at significant risk of complications related to contaminated feeding tubes. Feeding tube dwell time may affect the level of contamination. This study will determine if a maximum feeding tube dwell time of 48 hours reduces contamination compared to a maximum feeding tube dwell time of 7 days, thereby improving neonatal health outcomes.

Eligibility criteria: Inclusion Criteria:

* be born to a mother who is at least 18 years of age and English or Spanish speaking
* born at \< or equal to 30 weeks
* have a birthweight \< or equal to 1500 grams
* be born to a mother who is COVID Negative
* have a feeding tube placed within 24 hours of birth
* be expected to require a feeding tube for 4 weeks following birth.

Exclusion Criteria:

* infant with known congenital GI anomalies
* infants which are not expected to live
* infants will be withdrawn from the study if they require abdominal surgery for GI morbidities

Primary outcomes:
measure: Amount of Contamination
timeFrame: 24 hours
Secondary outcomes:
measure: Gastrointestinal Inflammation - S100A12
timeFrame: 4 weeks
measure: Gastrointestinal Inflammation - Calprotectin
timeFrame: 4 weeks
measure: Hours of Parenteral Nutrition
timeFrame: 4 weeks
measure: Days With a Central Venous Line
timeFrame: 4 weeks
measure: Length of Neonatal Intensive Care Stay
timeFrame: birth until discharge from the neonatal intensive care unit
measure: Days to Reach Full Feeds
timeFrame: 4 weeks
measure: Number of Infants With Necrotizing Enterocolitis
timeFrame: 4 weeks
measure: Number of Infants With Late Onset Sepsis
timeFrame: 4 weeks
measure: Episodes of Abdominal Distension
timeFrame: 4 weeks
measure: Number of Infants With a Direct Bilirubin > 2 mg/dL
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Unversity of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Leslie Parker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04032808: Evaluation of the Performance of Self-monitoring Optimized by Therapeutic Education in the Recurrence of Wet Age-related Macular Degeneration (AMD)
Official title: Evaluation of the Performance of Self-monitoring Optimized by Therapeutic Education in the Recurrence of Wet Age-related Macular Degeneration (AMD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-related Macular Degeneration
Lead sponsor: Clinique Beau Soleil
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with AMD who have had at least one recurrence after a shared education assessment in which they have indicated the need or desire to participate in the control of their disease and who agree to participate in a therapeutic education program at the Beau Soleil Clinic

Brief summary: Monocentric and prospective study, evaluating the benefit of self-monitoring optimized by therapeutic education either by the environmental Amsler or the Amsler grid according to the patient's choice and to determine the patient's ability to determine the reality itself recidivism and therefore the need for treatment.


Eligibility criteria: Inclusion Criteria:

* Affiliation to a social security scheme
* Patient agreeing to participate in the process of therapeutic education.
* Centrofoveal fixation with visual acuity\> 2/10
* Antecedent of at least one recurrence so that the patient is aware of the notion of recurrent chronic disease
* Intravitreal injection antecedent less than 6 months ago

Exclusion Criteria:

* Vulnerable people
* Majors subject to legal protection or unable to express their consent
* Arterial emboli disorders of less than three months such as myocardial infarction, stroke

Primary outcomes:
measure: Sensitivity and specificity of self-monitoring by the environmental Amsler or the clinical Amsler grid according to the choice of the patient after therapeutic education.
timeFrame: Through study completion, on average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Clinique Beau Soleil
Study officials:
References:
Clinical trial NCT06734208: A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function
Official title: A Phase 1, Open-Label, Single-Dose, Parallel-Cohort Study to Evaluate the Pharmacokinetics of Divarasib in Subjects With Impaired Hepatic Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 1, open-label, single-dose, parallel-cohort study to determine the pharmacokinetics (PK) of divarasib in healthy participants and participants with varying degrees of hepatic impairment, as defined by Child-Pugh classification.


Eligibility criteria: Key Inclusion Criteria

* Males or females of non-childbearing potential
* Within body mass index (BMI) range of 18.0 to 45.0 kg/m2

Participants with Hepatic Impairment

* Considered to have mild, moderate, or severe hepatic impairment by Child-Pugh Score classification and has been clinically stable for at least 1 month prior to Screening
* Chronic (\>6 months), stable hepatic insufficiency with features of cirrhosis due to any etiology. Participants must also remain stable throughout the Screening period

Key Exclusion Criteria

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator

Participants with Hepatic Impairment

* Have a QTcF \>480 msec for males and \>490 msec for females at Screening or Check-in. If any parameter is out of range, the ECG may be repeated for confirmation
* Any evidence of progressive liver disease that has worsened or is worsening, as determined by the investigator, within 1 month prior to Screening
* Demonstrated evidence of hepatorenal syndrome
* Ascites requiring paracentesis or other intervention up to 3 days prior to the study
* Hepatic encephalopathy Grade 2 or above

Primary outcomes:
measure: Plasma Concentration of Divarasib
timeFrame: Day 1 to Day 7
measure: Maximum Observed Concentration (Cmax) of Divarasib
timeFrame: Day 1 to Day 7
measure: Area Under the Concentration-time Curve from Hour 0 to the last measurable concentration (AUC0-t) of Divarasib
timeFrame: Day 1 to Day 7
measure: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib
timeFrame: Day 1 to Day 7
Secondary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to Week 10
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: