louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05611554: Effects of an ACT-based Psychological Treatment in Relatives of People With Intellectual Disabilities
Official title: Parental Stress, Health and Disabilities. A Training Programme in Psychological Flexibility During COVID 19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parent-Child Relations
Parental Stress
Keywords: stress
acceptance and commitment therapy
health
parent-child relations
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization assigned participants to 2 arms:

1. Treatment
2. Waiting list
Primary purpose: TREATMENT

Brief summary: Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of parental stress in relatives of people with intellectual disabilities

Detailed description: After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.

Patients who meet eligibility requirements will receive psychological intervention consisting in 3-session group ACT-based treatment.

The participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.

The clinical trial will include a control group.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* High level of understanding of Spanish
* Having children diagnosed with intellectual disability

Exclusion Criteria:

* Current psychological and/or psychiatric treatment,

Primary outcomes:
measure: Change in Perceived Stress Scale (PSS)
timeFrame: Change from Baseline perceived stress at 4 months
Secondary outcomes:
measure: Change in Parental Acceptance Questionnaire (6-PAQ)
timeFrame: Change from Baseline Psychological Inflexibility at 4 months
measure: Change in Psychological Health Questionnaire (GHQ-12)
timeFrame: Change from Baseline Psychological Well-Being at 4 months
measure: Change in White Bear Suppression Inventory (WBSI)
timeFrame: Change from Baseline thoughts suppression at 4 months
measure: Change in Behavioural self-monitoring
timeFrame: Change from Baseline punitive-hostile and supportive-companion behaviours at 1 month.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Europea de Madrid
state: Villaviciosa De Odón
Study officials:
affiliation: Universidad Europea de Madrid
name: Francisco Montesinos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02670954: Evaluation of the Effect of Appropriate Sedation for Patients After Abdominal Surgeries : A Prospective Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Sedation, Abdominal Surgery
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2016-02-02
Enrollment: 154
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of appropriate postoperative sedation with dexmedetomidine for patients after abdominal surgeries.Prospective randomised controlled study was conducted among patients after abdominal surgeries began in October 2015.The investigators enroll patients who received abdominal surgeries. One group receive sedative along with analgesic and the other group analgesic only for the other group on the first 24 hours after surgeries and will follow up for 3 days.


Eligibility criteria: Inclusion Criteria

* 16-85 years old
* underwent abdominal surgeries including enterectomy, gastrectomy, hepatectomy and pancreatectomy in the hospital and operation duration lasted at least 2 hours.

Exclusion Criteria

* take part in other clinical trials
* quinolone antibiotics intake 4 weeks prior to or within the study
* NSAIDS intake within one month
* history of peptic ulcer
* respiratory insufficiency
* renal insufficiency
* acute hepatitis or severe liver disease (Child-Pugh class C)
* pregnancy or lactation
* abnormal ECG with clinical significance
* uncontrolled hypotension
* bleeding tendency or hematological diseases
* untreated mechanical intestinal obstruction
* unable to express or any kind of mental disease.

Primary outcomes:
measure: postoperative pain
timeFrame: 1-3d after abdominal surgeries
measure: recovery of gastrointestinal function
timeFrame: from admission to 30 days after abdominal surgeries
measure: white blood cell count(10^9 /L)
timeFrame: 1-3d after abdominal surgeries
measure: C-reactive protein(mg/L)
timeFrame: 1-3d after abdominal surgeries
Secondary outcomes:
measure: percentage of time within target sedation range
timeFrame: 1-3d after abdominal surgeries
measure: risk of hypotension requiring interventions
timeFrame: 1-3d after abdominal surgeries
measure: risk of bradycardia requiring interventions
timeFrame: 1-3d after abdominal surgeries
measure: use of opioids and use of benzodiazepins
timeFrame: 1-3d after abdominal surgeries
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Institute of General Surgery of Jinling Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT03877354: Comparison of Tidal Volume Between Pediatric Anaesthesia and Paediatric Intensive Care Patients
Official title: Comparison of Tidal Volume Between Pediatric Anaesthesia and Paediatric Intensive Care Patients: Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Protective Ventilation
Keywords: ventilation
paediatric patient
mechanical ventilation
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 1000
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paediatric patients on mechanical ventilation in anaesthesia departmentand in intensive care department

Brief summary: Paediatric anaesthesiology and paediatric intensive care unit data will be retrospectively screened for the data regarding mechanical ventilation. The primary aim will be the tidal volume setting and the secondary the level of positive end-expiration pressure (PEEP) according to the inspired oxygen fraction (FIO2), and the level of driving pressure.

Detailed description: Protective positive pressure ventilation (tidal volume ≤6 mL/kg) in adult patients in intensive care is currently considered as a standard procedure. It is associated with a reduction of morbidity and positive outcome. In paediatric patients there are available only limited information related to the size of the tidal volume and it is recommended to use the volume between 5 and 8 mL per kg for the whole spectrum of ages of pediatric patients. The aim of this retrospective observational study is to evaluate the tidal volumes used in clinical practice in pediatric patients during general anesthesia and compared it to the tidal volumes used in paediatric critical care. Data will be harvested from the anaesthesiology records and from the paediatric intensive care unit charts. The tidal volume will calculated per kg of actual weight.

Eligibility criteria: Inclusion Criteria:

* Paediatric patients on mechanical ventilation in anaesthesia department
* Paediatric patients on mechanical ventilation in intensive care department
* In selected study period between 1.1.2018 - 31.1.2019

Exclusion Criteria:

* Age outside selected limits
* Insufficient data

Primary outcomes:
measure: Tidal volume
timeFrame: Intraoperative period
Secondary outcomes:
measure: Positive end-expiratory pressure settings according to the inspiration fraction of oxygen
timeFrame: Intraoperative period
measure: Driving pressure
timeFrame: Intraoperative period
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
state: State
Study officials:
affiliation: University Hospital Brno
name: Petr Stourac, assoc.Prof.MD.Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT06056154: Safety and Efficacy of the Hydrophobic Intraocular Lens Asqelio Monofocal With Biaspheric Design
Official title: Safety and Efficacy of the Hydrophobic Intraocular Lens Asqelio Monofocal With Biaspheric Design
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cataract
Pseudophakia
Lead sponsor: AST Products, Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 150
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects undergoing cataract surgery, implanted with ASQELIO monofocal model QLIO130C, and with a follow-up of more than 24 months.

Brief summary: The goal of this observational study is to learn about the Asqelio monofocal intraocular lens (IOL) model QLIO130C in patients undergoing cataract surgery. The aim of the study is to evaluate the lens implementation safety and efficacy after at least 24 months.

Detailed description: This is a retro-prospective, post-marketing observational study of a CE-marked medical device. The efficacy and safety of the Asqelio monofocal intraocular lens (IOL) model QLIO130C from AST Products, Inc, Billerica, USA, will be studied in patients implanted according to standard clinical practice. Twelve-month follow-up data will be collected from the medical records of the patients included in the study, and after 24 months they will be scheduled for a review.

Eligibility criteria: Inclusion Criteria:

* Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with ASQELIO monofocal model QLIO130C.
* Subjects for whom postoperative emmetropia (±0.5 D spherical equivalent) was planned.

Exclusion Criteria:

* Any pathology that reduces the potential Visual Acuity (VA) with its best correction beyond 0.30 logMAR.
* Previous corneal surgery.
* Rubella or surgery due to traumatic cataract.
* Ocular trauma or refractive surgery.
* Any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study

Primary outcomes:
measure: Incidence of Posterior capsular opacity
timeFrame: 24 months after IOL implantation
measure: Intensity of Posterior capsular opacity
timeFrame: 24 months after IOL implantation
measure: Visual acuity
timeFrame: At least 24 months after IOL implantation
Secondary outcomes:
measure: Refraction
timeFrame: At least 24 months after IOL implantation
measure: Incidence of Glistening
timeFrame: At least 24 months after IOL implantation
measure: Intensity of Glistening
timeFrame: 24 months after IOL implantation
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Oftalmología Vistahermosa SL
Study officials:
References:
Clinical trial NCT04945954: Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients
Official title: Pharmacokinetic Study of Post-transplant Cyclophosphamide in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Food and Drug Safety Evaluation (Republic of Korea)
First posted: 2021-06-30
Enrollment: 15
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of Cyclophosphamide in pediatric hematopoietic stem cell transplantation patients.


Eligibility criteria: Inclusion Criteria:

* Patients who had cyclophosphamide treatment for immunosuppressant after allogeneic hematopoietic stem cell transplantation
* Patients age \<19 years
* Written Study Informed consent and/or assent from the patient, parent, or guardian

Exclusion Criteria:

* Known hypersensitivity to mycophenolate mofetil or similar class of drug substance
* Patients in a medically critical condition such as severe infection or unstable vital signs
* Any condition that would, in the Investigator's judgment, interfere with full participation in the study
* Subjects who are pregnant or breast-feeding
* Subjects with psychiatric conditions that may interfere with the study
* Subjects who have a possibility of the disease getting worse as a treatment for clinical trials

Primary outcomes:
measure: Pharmacokinetics parameter of melphalan
timeFrame: Day -3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day -2: post 2 hour, post 3 hour, post 6 hour( Day 0 means the day when patients receive a HSCT)
measure: Pharmacokinetics parameter of melphalan
timeFrame: Day +3: post 2 hour, post 3 hour, post 6 hour, post 24 hour / Day +4: post 2 hour, post 3 hour, post 6 hour ( Day 0 means the day when patients receive a HSCT)
measure: Pharmacokinetics parameter of melphalan
timeFrame: D-3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D-2 post 2 hour, post 3 hour, post 6 hour / D+3 post 2 hour, post 3 hour, post 6 hour, post 24 hour / D+4 post 2 hour, post 3 hour, post 6 hour( D0 means The day when patients receive a HSCT)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: l
name: Hyoung Jin Kang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00498654: Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
Official title: A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of a Single Oral Dose Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Typhoid Fever
Keywords: Prevention of Typhoid Fever in Adult Travelers
Lead sponsor: Avant Immunotherapeutics
Sponsor class: INDUSTRY
First posted: 2007-07-10
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to examine the safety and immunogenicity of Ty800 oral vaccine in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy Males or Females aged 18 to 55 years, inclusive
* Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol

Exclusion Criteria:

* History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids
* History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time
* History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico
* History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease
* Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame.
* People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding

Primary outcomes:
measure: Immunogenicity
timeFrame: Baseline through Day 14
measure: Reactogenicity
timeFrame: Baseline through Month 1 follow-up
Secondary outcomes:
measure: Longterm safety and immunogenicity
timeFrame: Month 1 to 6 post-dosing
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Accelovance LLC
state: California
city: Melbourne
country: United States
facility: Accelovance LLC
state: Florida
city: Peoria
country: United States
facility: Accelovance LLC
state: Illinois
city: South Bend
country: United States
facility: Accelovance LLC
state: Indiana
city: Houston
country: United States
facility: Accelovance LLC
state: Texas
Study officials:
affiliation: Accelovance LLC
name: Clark McKeever, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01120054: Traumatic Brain Injury Among Homeless Veterans
Official title: Traumatic Brain Injury Among Homeless Veterans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Homelessness
Keywords: Traumatic Brain Injury
Homelessness
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
name: Corporal Michael J. Crescenz VA Medical Center
name: James A. Haley Veterans Administration Hospital
First posted: 2010-05-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Homeless Veterans

Brief summary: Objectives include: 1) establishing a psychometrically sound traumatic brain injury (TBI) screening measure for use among homeless veterans; 2) identifying the prevalence of those that screen positive for TBI among homeless veterans seeking VA services; and 3) comparing psychiatric and psychosocial outcomes between those with and without a history of TBI.

Detailed description: Short-term Objectives include:

1. Establishing the criterion-related validity of the Traumatic Brain Injury-4 (TBI-4) questionnaire in the Veteran homeless population using the Ohio State University TBI-Identification Method (OSU TBI-ID) (Corrigan et al., 2007) as the gold standard for establishing traumatic brain injury (TBI) diagnosis.
2. Identifying the prevalence of those that screen positive for a lifetime history of TBI among homeless Veterans.
3. Comparing psychiatric outcomes (psychiatric hospitalizations, suicide attempts and deaths, and clinical contacts) and psychosocial outcomes between those with and without a lifetime history of TBI.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age, seeking homeless services at one of the VA Homeless Services Programs.

Exclusion Criteria:

* Failure to provide informed consent, not older than 89 years of age.

Primary outcomes:
measure: OSU TBI-ID
timeFrame: One Time
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Department of Veterans Affairs, Eastern Colorado Health Care System
state: Colorado
city: Tampa
country: United States
facility: Tampa VAMC
state: Florida
city: Philadelphia
country: United States
facility: Philadelphia VAMC
state: Pennsylvania
Study officials:
affiliation: VISN 19 MIRECC
name: Lisa A. Brenner, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05790954: The Effect of Pre-Cesarean Section Guided Imagery
Official title: The Effect of Pre-Cesarean Section Guided Imagery on Preoperative Anxiety, Fear and Physiological Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the effect of guided imagery applied before cesarean section on preoperative anxiety, fear and physiological parameters.

The study will be carried out in two different groups. The practice will start with meeting the women 3 days before cesarean section. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out random. The following applications will be made to the groups.


Eligibility criteria: Inclusion Criteria:

* planned cesarean section
* Single birth
* giving birth at term
* No hearing problems
* Agreeing to participate in the research and obtaining written permission,

Exclusion Criteria:

* Emergency cesarean section due to a health problem of the mother or baby
* Not completing the study

Primary outcomes:
measure: Change in anxiety
timeFrame: Three days before the cesarean section, Fifteen minutes after preparation for cesarean section
measure: Change in Surgical Fear
timeFrame: Three days before the cesarean section, Fifteen minutes after preparation for cesarean section
Secondary outcomes:
measure: systolic and diastolic blood pressure
timeFrame: Fifteen minutes after preparation for cesarean section
measure: heart rate
timeFrame: Fifteen minutes after preparation for cesarean section
measure: body temperature
timeFrame: Fifteen minutes after preparation for cesarean section
measure: respiratory rate
timeFrame: Fifteen minutes after preparation for cesarean section
measure: fetal heart rate
timeFrame: Fifteen minutes after preparation for cesarean section
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Neslihan Yılmaz Sezer
state: Mamak
Study officials:
References:
Clinical trial NCT04861454: Brassiere Brow Suture and Internal Browpexy
Official title: Brassiere Brow Suture and Internal Browpexy as Disjunctive Upper Eyelid Blepharoplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eyelid Diseases
Keywords: blepharoplasty
browbexy
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 30
Sex: ALL
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: At least 18 years with dermatochalasis

Brief summary: Brow ptosis is a common problem. internal browbexy and brassier suture are common surgical approach

Detailed description: upper eye transcutaneous blepharoplasty then combined browbexy and brassier suture are done

Eligibility criteria: Inclusion Criteria:

* brow ptosis and dermatochalasis

Exclusion Criteria:

* eyelid diseases and previous surgery

Primary outcomes:
measure: global aesthetic scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: INMC
Study officials:
affiliation: Benha University
name: tarek elhamaky, MD
role: PRINCIPAL_INVESTIGATOR
References: