louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03174678: Dexmedetomidine Premedication in Children
Official title: The Effect of Oral Dexmedetomidine Premedication On Preoperative Cooperation and Emergence Delirium In Children Undergoing Dental Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premedication
Keywords: Dexmedetomidine
child
premedication
emergence delirium
dental treatment
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 100
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Retrospective study
Primary purpose: PREVENTION

Brief summary: The aim of this retrospective study was to detect the effectiveness of 1µg/kg oral dexmedetomidine premedication on preoperative cooperation and emergence delirium of the the young children underwent complete dental treatment.

Detailed description: One Hundred children between the ages 2-6 years of ASA I status underwent full mouth dental rehabilitation were enrolled in the study. Group Dex (n=50) received 1µg/kg dexmedetomidine in apple juice and Group control (n=50) received apple juice only. Patients' Ramsey Sedation Scale (RSS), The Parental Seperation Anxiety Scale (PSAS), Mask Acceptance Scale (MAS) and Post anesthesia emergence delirium scale (PAEDS) and hemodynamic parameters were noted from their patient file. Premedication period was 45 minutes and measurements of RSS and hemodynamic parameters were recorded in baseline and every 15 minutes until the patients were transferred to the operating room. The data were analysed using the Kruskal-Wallis test, two sample t- tests, chi-square tests and ANOVA.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria is age between 2 to 6 years and American Society og Anesthesiology (ASA) grade 1.

Exclusion Criteria:

* The exclusion criteria included congenital disease, DEX, propofol allergy, asthma, mental retardation and those children parents refuse to participate study.

Primary outcomes:
measure: Ramsey Sedation Score
timeFrame: 45 minutes after premedication
Secondary outcomes:
measure: Parental Separation Anxiety Score
timeFrame: preoperative
Other outcomes:
measure: Mask Acceptance Score
timeFrame: Before induction
Locations:
city: Aydın
country: Turkey
facility: Sultan Keles
state: Efeler
Study officials:
affiliation: Pediatric dentistry
name: sultan keles, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumari S, Agrawal N, Usha G, Talwar V, Gupta P. Comparison of Oral Clonidine, Oral Dexmedetomidine, and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Surgery. Anesth Essays Res. 2017 Jan-Mar;11(1):185-191. doi: 10.4103/0259-1162.194586.
citation: Keles S, Kocaturk O. The Effect of Oral Dexmedetomidine Premedication on Preoperative Cooperation and Emergence Delirium in Children Undergoing Dental Procedures. Biomed Res Int. 2017;2017:6742183. doi: 10.1155/2017/6742183. Epub 2017 Aug 20.
Clinical trial NCT05203978: Virtual Reality Colonoscopy : a Study From Nancy
Official title: Virtual Reality Colonoscopy : a Study From Nancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms
Colorectal Polyp
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patient needed planned colonoscopy and able to fill in questionnaires in French

Brief summary: Colonoscopy is an exam which can be responsible for pain and discomfort for the patient.

Therefore colonoscopy is performed most of the time under general anaesthesia. Moreover, drug-induced sedation comes with adverse effects especially among fragile patients.

Besides, monitoring patients during and after sedation is both logistically demanding and costly.

Virtual reality offers immersive and three dimensional experiences that distract the attention and might improve patients comfort.

The aim of the study is to investigate the use of virtual reality during colonoscopy versus general anaesthesia.

Detailed description: The study is based on a home made questionnaires completed by the operator and the patient before and after the colonoscopy.

Eligibility criteria: Inclusion Criteria:

* patient needed planned colonoscopy
* able to fill in questionnaires in French

Exclusion Criteria:

* visual or auditor impairments
* dementia patient
* limited French language skills
* diagnosis of balance disorders or epilepsy

Primary outcomes:
measure: Complete colonoscopy defined by caecum intubation (binary criterion : yes or no)
timeFrame: baseline
Secondary outcomes:
measure: Pain evaluated by Numeric Rating Scale during the procedure (0 no pain and 10 highest imaginable pain)
timeFrame: baseline
measure: Anxiety evaluated by the validated score State Trait Anxiety Inventory ranging from 20 (absence of anxiety) to 80 (highest anxiety)
timeFrame: baseline
measure: Comfort evaluated by Gloucester Comfort Scale between 1 comfortable and 5 severe discomfort
timeFrame: baseline
measure: Satisfaction evaluated on scale of willingness to return (0 no willing at all to 10 definitively willing)
timeFrame: baseline
measure: Polyp removal (binary criterion : yes or no)
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05952778: Reminder Messages for Lung Cancer Screening
Official title: Reminder Messages for Lung Cancer Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skin Flaps
Lung Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 130
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: M D Anderson Cancer Center

Brief summary: To test lung cancer screening reminder messages to help adults who 1) 50 to 80 years of age, 2) smoke or have smoked, and 3) do not have history of lung cancer by self-report.

Detailed description: Primary Objectives:

-In this project we will develop, refine, and test reminders for LCS to ensure they are acceptable to patients who have a history of cigarette use.

Eligibility criteria: Inclusion Criteria:

* Adults ages 40-80 years
* Currently use combustible tobacco products or used combustible tobacco products in the past
* English or Spanish speaker (based on self-report) Or an adult caregiver/care partner or family member of someone with a history of combustible tobacco product use (may participate in focus groups, cognitive interviews, surveys)

Exclusion Criteria:

• History of lung cancer (based on self-report)

Primary outcomes:
measure: Ottawa Acceptability questionnaires
timeFrame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Robert Volk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03196778: Low Dose Hemi-body Radiation For Recurrent Prostate Cancer
Official title: Non-Targeted Low Dose Radiotherapy For Recurrent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Juravinski Cancer Center
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Mitacs
name: Northern Ontario School of Medicine
First posted: 2017-06-23
Enrollment: 21
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Older studies in animals and humans have shown cancer responses to very low doses of whole-body or hemi-body radiation. To study the effects of low doses of radiation in patients with recurrent prostate cancer, investigators will enroll up to 21 patients for 10 fractions of low dose radiation, delivered over 5 weeks. Participants will be followed on study for 12 months, capturing PSA, CBC, QoL and blood samples for immunological analysis.


Eligibility criteria: Inclusion Criteria:

* A confirmed diagnosis of prostate cancer.
* Having undergone prior prostate surgery or radiotherapy or both.
* Evidence of recurrence of the disease as demonstrated by rising PSA levels. Patients are eligible if on androgen blockade or hormone naïve.

Exclusion Criteria:

* Prior treatment with chemotherapy and/or abiraterone and/or enzalutamide and/or radium-223.
* Receiving treatment with immunosuppressive medications.
* Platelet count below 50,000/µl (50 x 109/l) or leukocyte count below 3,000/µl (3 x 109/l) or granulocyte count below 2,000/µl (2 x 109/l).
* Other medical conditions or co-morbidities which, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.
* Language difficulties which may hinder the patient's ability to complete the trial.
* Inability of the potential participant to provide consent.
* Lack of independence in daily living activities and any other conditions which, in the opinion of the Investigator, will hinder the participant's ability to participate and complete the study obligations.

Primary outcomes:
measure: PSA response
timeFrame: Within 12 months of study treatment
Secondary outcomes:
measure: Immunological changes
timeFrame: Within 12 months of study treatment
measure: Adverse Events
timeFrame: Within 12 months of study treatment
measure: Quality of Life
timeFrame: Within 12 months of study treatment
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
References:
Clinical trial NCT04738578: A Comparison of Bowel Preparation for Colonoscopy Between Digestive Physicians and Non-digestive Physicians
Official title: A Comparison of Bowel Preparation for Colonoscopy Between Digestive Physicians and Non-digestive Physicians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Preparation
Keywords: Predictive factors
Outpatients
Colonoscopy
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 671
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients undergoing colonoscopy

Brief summary: The diagnostic accuracy of colonoscopy depends on the quality of bowel preparation, which is a critical element associated with the diagnostic yield, difficulty, time required, and the completeness of colonoscopy. The non-digestive physicians seemed to have a lower quality of bowel preparation compare to the digestive physicians. Therefore, investigators planned to evaluate the risk factors for suboptimal intestinal preparation in outpatients from the perspective of digestive doctors and non-digestive.


Eligibility criteria: Inclusion Criteria:

* All outpatients who have already completed the colonoscopy during December 2019 and October 2020.

Exclusion Criteria:

* Patients with incomplete critical information, primary outcome, and baseline characteristics missing as well as examinations in hospitalized patients were excluded.

Primary outcomes:
measure: Adequate bowel preparation
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo first hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT04240678: The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening
Official title: The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Keywords: Mass Screening
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 8299
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Asian and Pacific Islander Americans at risk, but never tested for chronic hepatitis B have been randomized to receive an electronic alert in their electronic medical chart to remind primary care physicians to screen them for chronic hepatitis B.


Eligibility criteria: Inclusion Criteria: Asian and Pacific Islanders (API) who have not yet received HBsAg testing. API will be identified using a novel algorithm which identifies them using their surname, language preference, country of origin.

-

Exclusion Criteria: Previous HBsAg completion.

-

Primary outcomes:
measure: Serum Hepatitis B Surface Antigen Completion
timeFrame: up to 12 months
Secondary outcomes:
measure: Serum Hepatitis B Surface Antigen Positivity
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Chak E, Li CS, Chen MS Jr, MacDonald S, Bowlus C. Electronic health record alerts enhance mass screening for chronic hepatitis B. Sci Rep. 2020 Nov 5;10(1):19153. doi: 10.1038/s41598-020-75842-8.
Clinical trial NCT01326078: Use of Lipid Emulsion or Nanoemulsion of Propofol on Children Undergoing Ambulatory Invasive Procedures.
Official title: Comparison Between Propofol Nanoemulsion and Propofol Lipid Emulsion on Children Undergoing Ambulatory Invasive Procedures.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Leukemia
Keywords: sedation
children
leukemia
bone marrow biopsy
Lead sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
Sponsor class: INDUSTRY
Collaborators: name: Professor Fernando Figueira Integral Medicine Institute
First posted: 2011-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the safety and efficacy of the of propofol nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures.

Detailed description: Nanoemulsion of propofol has been developed without lipid solvent in the formulation to minimize the adverse events such as pain of injection, redness, heat, phlebitis.

Eligibility criteria: Inclusion Criteria:

* Lumbar Puncture or Myelogram
* Peripheral Intravenous access available in the veins on the dorsal region of the hand
* The informed consent signed by the legal responsible of the child allowing the participation in the study

Exclusion Criteria:

* Relative or absolute contraindications use of propofol and excipients
* Contraindications to the patient undergo general anesthesia or sedation with drug
* Allergy derived from egg or soy
* Use of pre-medication
* Patient receiving psychotropic drugs
* Use of opioid within 24 hours
* The responsible for the children unable to decide for his participation
* The severity of the condition wich compromises vital functions such as ventilation and hemodynamic balance
* Liver cancer which compromises its function
* Changes in the blood tests
* Others comorbidities in the investigator opinion

Primary outcomes:
measure: Classification of the sedation level
timeFrame: time 0
Secondary outcomes:
measure: Time of latency
timeFrame: 3-10 seconds
measure: Pain at injection
timeFrame: 3 - 10 seconds: during the injection
measure: Physician satisfaction
timeFrame: 12 hours: end of procedure
measure: Awakening time
timeFrame: 10 hours: when the patient awakes
measure: Total dose
timeFrame: 12 - hours End of procedure
measure: Incidence of Adverse Events
timeFrame: 0 to 14 hours
Other outcomes:
Locations:
Study officials:
affiliation: IMIP
name: Luciana C Lima, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06189378: Adherence to Blood Pressure Diaries With Personalized Visuals
Official title: Picture This: A Randomized Controlled Pilot Study Investigating Adherence to Blood Pressure Diaries With Personalized Visuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurovascular Disorder
Keywords: adherence
blood pressure diary
stroke
TIA
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial randomizes patients with a neurovascular diagnosis to a type of blood pressure diary for secondary stroke prevention (conventional blood pressure diary or blood pressure diary including patient-provided images). Outcomes include adherence and patient-reported outcomes.

Detailed description: In this prospective trial, the investigators randomized persons with diagnoses of stroke or transitoric ischemic attack into two groups: (i) 10 patients received a personalized blood pressure diary with pictures of their choosing. (ii) 10 patients received a blood pressure diary without photographs. The investigators instructed participants in either group to document their blood pressure at home twice daily over twenty-eight days.

Eligibility criteria: Inclusion Criteria:

* diagnosis of TIA or stroke (ischemic or hemorrhagic) upon admission.

Exclusion Criteria:

* Modified Rankin Scale score of ≥4 at inclusion
* Inability to provide informed consent
* Pre-existing legal guardianship.

Primary outcomes:
measure: Adherence
timeFrame: 28 days
Secondary outcomes:
measure: Blood pressure
timeFrame: 28 days
measure: Precision of documentation of blood pressure
timeFrame: 28 days
measure: Patient Global Impression of Change Scale
timeFrame: 28 days
measure: 36-Item Short Form Health Survey
timeFrame: 28 days
measure: Hospital Anxiety and Depression Scale
timeFrame: 28 days
Other outcomes:
measure: Exploratory endpoints
timeFrame: 28 days
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Clemens Farr, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00109278: A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)
Official title: A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured From the 2003 Measles Stock Seed With Recombinant Human Albumin (rHA) Versus Currently Licensed V205C Manufactured From the 1967 Measles Stock Seed With Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Measles
Keywords: Prevention of Measles
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-04-26
Enrollment: 1100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).

Detailed description: The duration of treatment is 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Healthy children 12 to 18 months of age.

Exclusion Criteria:

* Previous receipt of measles, mumps, rubella and/or varicella vaccine.
* Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster.
* Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy.
* History of seizures (convulsions)
* Allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin.
* A recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° F \[37.5° C\]).

Primary outcomes:
measure: Antibody response rate to measles at 6 weeks postvaccination
Secondary outcomes:
measure: Geometric mean titers to measles by ELISA at 6 weeks postvaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01375478: An Observational Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis
Official title: Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-17
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis

Brief summary: This open-label, retrospective, observational study will evaluate the compliance to RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. Six months data will be collected from patients records.


Eligibility criteria: Inclusion Criteria:

* Adult patients, over 18 years of age
* Moderate to severe rheumatoid arthritis
* RoActemra/Actemra treatment must have been initiated 6 months prior to signing the informed consent form

Exclusion Criteria:

* Patients with rheumatic autoimmune disease other than rheumatoid arthritis
* Patients who are not willing to sign the informed consent form
* Patients who participate in interventional trials during the period of this observational study

Primary outcomes:
measure: Percentage of patients who remained under continued RoActemra/Actemra treatment
timeFrame: 6 months
Secondary outcomes:
measure: Reasons for withdrawal
timeFrame: 6 months
measure: Frequency of withdrawal
timeFrame: 6 months
measure: Frequency of dose modification
timeFrame: 6 months
measure: Reasons for dose modification
timeFrame: 6 months
measure: Safety: Incidence of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Crete
country: Greece
city: Patras
country: Greece
city: Patra
country: Greece
city: Patra
country: Greece
city: Rhodes
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Voula
country: Greece
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: