louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05026203: Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression
Official title: Effectiveness of Ketamine Treatment in Difficult-to-treat Depression Comparing With Midazolam: a Double-blind Randomized Controlled Trial and Its Cost Effectiveness Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inclusion criteria: 1. patient over 20 years old with depression diagnosed by a psychiatrist and MADRS \>= 25 scores; 2. failed to improve by at least optimal dosage of two antidepressants for four weeks and one psychotherapy. Patients and outcome assessors will be blinded from intervention the patients have.

Participants will be randomized into two groups that are intervention (ketamine 0.5 mg/kg IV drip in 40 minutes) and control (midazolam 0.045 mg/kg IV drip in 40 minutes) groups. Participants will administer ketamine/midazolam once daily for three consecutive days. They will be evaluate MADRS changing, vital signs, dissociative symptoms, CGI, and quality of life (EQ-5D-5L) during the treatment, at 1 week and 4 weeks after treatment completion.


Eligibility criteria: Inclusion Criteria:

* over 20 years old
* depression was diagnosed by a psychiatrist and having MADRS \>= 25
* depression treated with 2 optimal dosage of antidepressants for 4 weeks and one psychotherapy
* stable dosage of current medications for 4 weeks
* fluently Thai

Exclusion Criteria:

* secondary depression
* PTSD
* current pregnancy
* history of increased intracranial hemorrhage, increased intracranial pressure, severe head injury, abnormal thyroid function, angina, heart failure, arrhythmia, aneurysm, uncontrolled hypertension, chronic lower tract respiratory disease, myasthenia gravis, glaucoma, dementia, acute porphyria, or cystitic (within 3 months prior to recruitment)
* allergy to ketamine or midazolam
* history of substance use disorder within 1 year prior to recruitment
* history of psychosis within 3 months
* history of bipolar disorder
* BMI over 35
* frail medical condition
* currently ECT or TMS

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 1 month
Secondary outcomes:
measure: dissociation
timeFrame: immediately after administraion
measure: health questionnaire
timeFrame: 1 month
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Keerati Pattanaseri
Study officials:
References:
Clinical trial NCT06958003: Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Official title: Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diaper Dermatitis
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 320
Sex: ALL
Minimum age (years): 30
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the use of 3-5 minutes air therapy for the prevention and treatment of diaper dermatitis in infants 30 weeks and older receiving care in the neonatal intensive care unit (NICU).


Eligibility criteria: Inclusion Criteria:

* Receiving care at Good Samaritan Hospital NICU
* At least 30 weeks gestation at birth and corrected or older or corrected gestation
* Birth to 1 year old
* Stable vital signs (temperature, pulse, blood pressure, and oxygen saturation)

Exclusion Criteria:

* Parent/legal guardian unable or unavailable to consent to involvement in the study
* Congenital malformation impacting diaper area or spine

Primary outcomes:
measure: Occurrence of diaper dermatitis
timeFrame: from admission to discharge from NICU, up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Gina Marie Allaire
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01486303: Facial Cosmetic Acupuncture on Skin Rejuvenation
Official title: Efficacy and Safety of Facial Cosmetic Acupuncture on Skin Rejuvenation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Aging
Skin Wrinklings
Keywords: Facial Cosmetic acupuncture
Skin Rejuvenation
Skin Aging
Lead sponsor: Kyunghee University
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 28
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Facial Cosmetic Acupuncture technique includes wrinkles, acupoints and muscle points on the face, head and neck. This study is designed to determine the efficacy and safety of Facial Cosmetic Acupuncture on skin rejuvenation.


Eligibility criteria: Inclusion Criteria:

* Patient age of 40 to 59 years
* Glogau photoaging scale III-IV

Exclusion Criteria:

* Who had undergone any dermabrasion, deep skin peels, laser resurfacing (ablative or non-ablative), botulinum toxin or filler injection, topical steroid within 6 months prior to study entry
* Patient with obvious skin disease
* Patient with a history of chronic skin disease
* Keloidal or hypertrophic scar tendency
* Pregnant or lactating patients

Primary outcomes:
measure: Criteria for evaluating Moire's topography
timeFrame: At 3 weeks (post treatment)
Secondary outcomes:
measure: Glogau classification system
timeFrame: At 3 weeks (post treatment)
measure: One-click Automatic Full face Analysis system
timeFrame: At 3 weeks (post treatment)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Department of Oriental Dermatology, College of Oriental Medicine, Kyung Hee University
name: In-Hwa Choi, KMD,PhD
role: STUDY_CHAIR
affiliation: Department of Oriental Dermatology, College of Oriental Medicine, Kyung Hee University
name: Younghee Yun, KMD,Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01700803: Povidone Iodine and Cesarean Section Wound Infections
Official title: Povidone Iodine 10% Versus 7.5% Hand Scrub and Cesarean Section Wound Infections: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wound Infections
Keywords: Betadine
Povidine Iodine
Hand scrubbing
Cesarean section wound infections
post cesarean section
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 3231
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section wound infections \& compare side effects of both agents.

Detailed description: For centuries, hand washing with soap and water has been considered the main approach for personal hygiene. In the community, hand hygiene has been known to prevent infectious diseases and to decrease the burden of disease. Currently, hand hygiene is considered the most important measure for preventing the spread of pathogens in health-care settings.

There are multiple agents used for surgical hand scrubbing as alcohol, chlorhexidine, iodine/iodophors, para-chloro-meta-xylenol \& triclosan. Ideally, the optimum antiseptic used for scrub should have broad spectrum of activity, persistent effect \& fast acting. Unfortunately most studies evaluating surgical scrub antiseptics have focused on measuring hand bacterial colony counts. No randomized clinical trials have evaluated the impact of surgical scrub choice on surgical site infection risk \& proven its efficiency.

Eligibility criteria: Inclusion Criteria:

* elective caesarian section (CS)

Exclusion Criteria:

* diabetes,
* immuno-compromised patients

Primary outcomes:
measure: The difference of incidence of surgical site infection between both groups
timeFrame: 4 month
Secondary outcomes:
measure: The difference in the side effects between both groups e.g. dermatitis
timeFrame: 4 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References:
Clinical trial NCT06564103: Stratification for F-L Therapy After LT
Official title: Stratification for Efficacy of Adjuvant FOLFOX Plus Lenvatinib After Liver Transplantation for Hepatocellular Carcinoma in Recurrence Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Adjuvant FOLFOX Plus Lenvatinib
Machine Learning
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recipients at Shulan (Hangzhou) Hospital from January 2017 to December 2021 were included in the analysis, which comprised 106 recipients in the F-L therapy group and 229 non-adjuvant (N-A) therapy group recipients.

Brief summary: Objective: To stratify recipients who underwent adjuvant FOLFOX plus lenvatinib (F-L) therapy following liver transplantation (LT) for hepatocellular carcinoma and provide guidance for clinical adjuvant therapy.

Methods: Liver recipients in the Shulan (Hangzhou) Hospital from January, 2017 to December, 2021, including 106 in the F-L therapy group and 229 in the non-adjuvant (N-A) therapy group were included in the analysis. A 1:1 propensity score matching (PSM) analysis was performed to minimize group imbalances. Disease-free survival (DFS) and overall survival (OS) were compared among recipients. Radiomics features that demonstrated predictive value for recurrence were employed, either independently or in conjunction with prognostic clinical features, to formulate predictive models. The combined model was used to perform further subgroup analysis for recipients in the F-L therapy group.


Eligibility criteria: Inclusion Criteria:

* patients fulfilling the Hangzhou criteria or exceeding the Hangzhou criteria with type 1 or 2 portal vein tumor thrombus (PVTT) before LT

Exclusion Criteria:

* 1) individuals less than 18 years old; 2) individuals with malignancies other than HCC; 3) individuals who survived less than 30 days after LT; and 4) individuals who lacked important prognostic variables, such as contrast-enhanced CT imaging information one month before transplantation, preoperative alpha-fetoprotein (AFP) levels, and tumor differentiation data

Primary outcomes:
measure: The disease-free survival rate was evaluated by follow-up investigation and outpatient review
timeFrame: 1-5 years
Secondary outcomes:
measure: The overall survival rate was evaluated by follow-up investigation and outpatient review
timeFrame: 1-5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang University school of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT02682303: Effect of Elastic Bandage on Balance in Chronic Ankle Instability
Official title: Effect of Elastic Bandage on Measurements of Balance in Subjects With Chronic Ankle Instability: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Sprain
Keywords: Adhesive elastic bandaging
balance
posturography
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 28
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: To report the immediate and prolonged (one week) effects of elastic bandage on balance control in subjects with chronic ankle instability.

Material and methods: Twenty-eight individuals successfully completed the study protocol, of whom 14 were randomly assigned to the elastic bandage group (7 men, 7 women) and 14 were assigned to the non-standardized tape group ( 9 men, 5 women). To objectively measure postural sway we used computerized dynamic posturography with Sensory Organization Test and Unilateral Stance test. We analyzed the following Sensory Organization Test parameters: the composite Sensory Organization Test score, the composite Sensory Organization Test strategy and the Sensory Organization Test condition 2 and its strategy. In addition, we studied the centre of gravity sway velocity with open eyes and close eyes during the US test.


Eligibility criteria: Inclusion Criteria:

Subjects with Chronic Ankle Instability

Exclusion Criteria:

Neurologic disease Vestibular disease

Primary outcomes:
measure: Balance using a computerized dynamic posturography test: the sensory organization test
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Francisco Molina Rueda. Avda. de Atenas. s/n.
state: Madrid
Study officials:
References:
Clinical trial NCT06464003: Orthodontic Screening in Public Healthcare
Official title: Orthodontic Screening and Treatment Need in Public Health Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malocclusion
Compliance, Patient
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 350
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unselected population sample study

Brief summary: The aim of the study is to examine orthodontic screening practises in public health care.

Detailed description: The study aims to assess repeatability of malocclusion evaluation in orthodontic treatment need screening in a publicly funded clinic. The objective treatment need is compared with subjective need for orthodontic treatment.

Eligibility criteria: Inclusion Criteria:

* residence in the wellbeing services county catchment area
* willingness to participate in the study

Exclusion Criteria:

* Age under 6 years or over 16 years
* insufficient language skills to be able to understand the questionnaire

Primary outcomes:
measure: Treatment need
timeFrame: Baseline
Secondary outcomes:
measure: Subjective evaluation
timeFrame: Baseline
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
city: Vantaa
country: Finland
facility: Vantaa and Kerava wellbeing services county
Study officials:
affiliation: University of Helsinki
name: Heidi Arponen
role: STUDY_DIRECTOR
References:
Clinical trial NCT01628003: Study of Reserves After Traumatic Brain Injury
Official title: Study of Reserves After Traumatic Brain Injury:Influence of Brain, Cognitive, and Emotional Reserves on Long-Term Consequences of Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
long-term outcome
Brain Reserves
Cognitive Reserves
Emotional Reserves
Patients 1 year or more after Moderate or Severe Traumatic Brain Injury
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-06-26
Enrollment: 240
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: It is hypothesized that the long-term results of rehabilitation and subsequent aging after Brain Trauma depend on brain's premorbid anatomical (structural) and functional (cognitive, emotional) reserves.

The purpose of this study are:

1. to determine whether such reserves exist.
2. to study their convergent and discriminant validity.
3. to study their characteristics.


Eligibility criteria: Inclusion Criteria:

* Moderate-Severe Traumatic Brain Injury according to at least 1 the following:

  * Duration of loss of consciousness (LOC) - more then 1/2 hour
  * Glasgow Coma Scale (GCS) - less then 13
  * Post Traumatic Amnesia (PTA) - more then 24 hours.
* At least 1 year after the injury.

Exclusion Criteria:

* Mild Traumatic Brain Injury
* the present state of Post Traumatic Amnesia
* dementia
* the age less than 18 years on the moment of injury
* less than 1 year since the injury
* incapacity of the patient to cooperate in the study (incapacity of any source including physical, mental, and language problems)
* premorbid diagnosis of Mental Retardation

Primary outcomes:
measure: Neuropsychological battery
timeFrame: neuropsychological baterry for every participant will be performed during 3-4 meetings. An expected average for complete neuropsychological assessment is about 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Tel Hashomer Medical Center
Study officials:
References:
Clinical trial NCT02699203: Detection of Salivary Insulin Following Meals
Official title: Detection of Salivary Insulin Following Low Versus High Carbohydrate Meals in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Mitacs
First posted: 2016-03-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In addition to its role as the major regulator of glucose uptake into peripheral tissues, the hormone insulin is also a primary regulator of fat storage and fat burning of the body. Mechanistic animal studies have shown that high insulin may be the initial trigger for weight gain and be the proximal cause of obesity. There is currently no quick or non-invasive way of measuring insulin as research and clinical techniques require collection of a blood sample followed by a complicated and costly biochemical assay. The investigators will test the hypothesis that insulin levels can be accurately measured in saliva in humans following meals that elicit high and low blood insulin responses. Findings will help determine if insulin can be use as a valid fluid to track insulin changes in humans.

Detailed description: Lean and obese healthy participants will consume both a high carbohydrate meal and a low carbohydrate meal designed to elicit different insulin responses on two separate occasions. Blood samples and saliva samples will be collected for 2 hours following each meal and insulin will be measured in both plasma and saliva. The relationship between plasma and saliva insulin following the two meals will be assessed.

Eligibility criteria: Inclusion Criteria:

* Body mass index between 18.5-24.9 or over 30.0 kg/m2

Exclusion Criteria:

* Diabetes or other medical conditions affecting glucose or insulin levels
* Smoker
* Competitive athlete
* Vegan or vegetarian

Primary outcomes:
measure: Peak plasma insulin level
timeFrame: 0-120 minutes
Secondary outcomes:
measure: Plasma insulin area under the curve
timeFrame: 0-120 minutes
measure: Relationship between peak saliva and peak plasma insulin
timeFrame: 0-120 minutes
measure: Timing of peak saliva and peak plasma insulin
timeFrame: 0-120 minutes
measure: Relationship between saliva insulin area under the curve and plasma insulin area under the curve
timeFrame: 0-120 minutes
measure: Peak saliva insulin level
timeFrame: 0-120 minutes
measure: Saliva insulin area under the curve
timeFrame: 0-120 minutes
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia, Okanagan.
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jonathan P Little, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06003803: Digital Learning on Competence in Motivational Interviewing
Official title: Effects of Self-Regulated Digital Learning on Competence in Motivational Interviewing on Patients' Medication Adherence Among Psychiatric Mental Health Nurses
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nurse's Role
Motivation
Keywords: digital learning
motivational interviewing
self-regulation
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Motivational interviewing is an essential practical skill to promote medication adherence; however, it is rarely emphasised in nursing education. Purposes: 1. To develop a self-regulated digital learning system for motivational interviewing; 2. To evaluate the effectiveness of digital learning of motivational interviewing on mental health nurses' knowledge, skills and self-efficacy (confidence); 3. To compare the effectiveness of self-regulated digital learning, blended learning and treatment as usual learning.


Eligibility criteria: Inclusion Criteria:

* psychiatric registered nurse

Exclusion Criteria:

* nursing administrator
* expected to resign within three months
* blended learners who have participated in motivational interviewing

Primary outcomes:
measure: motivational interviewing skill
timeFrame: The time point of measurement is the baseline, the change in the 3month after the intervention, and the change in the 6 month]
Secondary outcomes:
measure: Motivational Interviewing Knowledge and Attitudes Test (MIKAT)
timeFrame: The time point of measurement is the baseline, the change in the 3month after the intervention, and the change in the 6 month]
measure: Motivational Interviewing Confidence Survey (MICS)
timeFrame: The time point of measurement is the baseline, the change in the 3month after the intervention, and the change in the 6 month]
Other outcomes:
measure: self-regulation scale for Taiwanese college students (TSSRQ)
timeFrame: The time point of measurement is the baseline, the change in the 3month after the intervention, and the change in the 6 month]
Locations:
city: Taipei City
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
Study officials:
References: