louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06097169: Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Dental Treatment
Official title: Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Dental Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Postoperative Pain
Nausea
Keywords: Dexmedetomidin
dental treatment
post operative anxiety
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included

Brief summary: Dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. The purpose of this run is to use the association between this use during surgery and the attrition of post-operative pain and discomfort. In the research, laboratory and monitoring results will be obtained before, during and after the operation. Postoperative patient complaints will be evaluated at the postoperative service visit. This study is decided on a completely voluntary basis.


Eligibility criteria: Exclusion Criteria:

Inclusion Criteria:

Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included.

Exclusion Criteria:

developmental delay anxiety disorder Known history of allergy to alpha-2 agonistic agents use of antipsychotic medication beta blocker use of anticonvulsant drugs chronic pain syndrome with cardiac and craniofacial anomalies

Primary outcomes:
measure: postoperative pain
timeFrame: Pain was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.
measure: postoperative anxiety
timeFrame: anxiety was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References:
citation: Zhou D, Yang XD, Wu HY, Xiong GL, Wang LK. Determination of the ED90 of Dexmedetomidine Infusion to Prevent Emergence Agitation in Children Undergoing Dental Rehabilitation With Sevoflurane Anesthesia: A Biased-Coin Up-and-Down Sequential Allocation Trial. Anesth Analg. 2024 Oct 1;139(4):761-769. doi: 10.1213/ANE.0000000000006626. Epub 2024 Jul 21.
Clinical trial NCT01326169: ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients
Official title: ReDIAL: A Telephone Brief Intervention for Injured Emergency Department Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Keywords: Alcohol
brief intervention
injuries
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to reduce impaired driving, risky driving and alcohol-related negative consequences among injured emergency department (ED) patients through a telephone brief intervention. This study will allow researchers to test a novel method of brief intervention that has the potential to be convenient and efficient mechanism to deliver an intervention to an at-risk population. Eligible patients will be consented in the ED, will receive an assessment and then will be randomized into one of two conditions: 1) telephone brief intervention or 2) a comparison control group with a home safety educational program. The participant will also receive an appointment for an initial telephone call. Both conditions will be provided over three telephone sessions: the initial call (immediately following randomization) and two booster calls at 2 weeks and 6 weeks after randomization. Participants will provide information about their alcohol use, alcohol-related injuries, impaired driving, and other driving related negative consequences at 4, 8, and 12 months post-randomization.


Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking
* Age greater than 17 years
* ASSIST score \>=11
* Injured Emergency Department patient at time of consent

Exclusion Criteria:

* Medically unable to give consent
* Not English or Spanish speaking
* Homeless
* Cannot be contacted by telephone

Primary outcomes:
measure: Change in number of patients with alcohol-related negative consequences from baseline to 4, 8, and 12 months post-randomization
timeFrame: Change from baseline in alcohol-related negatve consequences at 4, 8, and 12 months
Secondary outcomes:
measure: Evaluation of mechanisms of change model
timeFrame: 12 months post-randomization
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Michael J Mello, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mello MJ, Baird J, Lee C, Strezsak V, French MT, Longabaugh R. A Randomized Controlled Trial of a Telephone Intervention for Alcohol Misuse With Injured Emergency Department Patients. Ann Emerg Med. 2016 Feb;67(2):263-75. doi: 10.1016/j.annemergmed.2015.09.021. Epub 2015 Nov 14.
Clinical trial NCT05713669: Impact of Resident Participation in Post-ICU Follow Up Clinic
Official title: Impact of Resident Participation in Post-ICU Follow Up Clinic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Professional Burnout
Keywords: Perceptions of critical care
Professional fulfillment.
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Total of 20 residents will be recruited (10 residents in the intervention arm; 10 residents in the control arm). One resident in each pair will be randomized to participate in a follow up encounter in the post-ICU clinic with the patient that residents have cared for (intervention) and one will have no follow up encounter (control). There will be 10 patients enrolled for the study and will not be randomized into any arm. Outcomes are based on the residents only.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is being conducted to describe the impact of a meeting between patients that were admitted to the intensive care unit (ICU) and a provider that cared for the patients during the period of critical illness. The study team is aiming to describe the effect this meeting has on the physician that previously cared for the patient.

The study team hypothesizes that facilitating involvement in post-ICU clinic and creating longitudinal relationships between providers of critical care and survivors of critical illness will have positive effects on trainees, both in professional fulfillment and burnout scores and in perceptions of critical care.

Detailed description: Physicians and patients that had been cared for in the ICU will be enrolled in this project. Residents that are recruited will be randomized to the encounter group or the control group.

Eligibility criteria: Inclusion Criteria for Patients:

- Must be eligible for Post ICU Longitudinal Survivor Experience (PULSE) clinic follow up and/or have received referral to clinic

Inclusion criteria for Residents:

* Must have completed at least one 2-week rotation in the medical ICU at the University of Michigan
* Must have cared for an enrolled patient in the study

Exclusion Criteria for Patients:

- Died during ICU stay

Exclusion Criteria for Residents:

- Provided only "cross-cover" for the patient.

Primary outcomes:
measure: Changes in the Professional Fulfillment Scale
timeFrame: Baseline (pre-post ICU follow-up visit), approximately 14 days post patient's follow-up visit
measure: Changes in the Burnout Scale
timeFrame: Baseline (pre-post ICU follow-up visit), approximately 14 days post patient's follow-up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jakob McSparron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00277368: A Study of the Prevalence of Headache in Epileptic Patients
Official title: Headache in Epileptic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Headache
Seizure
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2006-01-16
Enrollment: 719
Sex: ALL
Minimum age (years): 13
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a recent diagnosis epilepsy; able to describe their symptoms by themselves; have had at least 2 episodes of seizures during the previous year; have had at least 1 headache during the previous year.

Brief summary: The purpose of this study is to investigate the prevalence, characteristics and classification of headaches in epileptic patients.

Detailed description: Headache is often ignored as a symptom of epileptic seizures. The purpose of this survey is to investigate the prevalence, characteristics and classification of seizure-associated headaches and non-seizure-associated headaches in epileptic patients in Korea, according the criteria of the International Headache Society 2004. In this survey, 577 consecutive patients with a recent diagnosis of epilepsy are interviewed by questionnaire about headaches associated with epileptic seizures. It involves questions about headache in general, localization, severity, duration and frequency, as well as headache associated with seizures, and about patient's family history. This Observational study does not involve the administration of any drugs.

Eligibility criteria: Inclusion Criteria:

* Patients with a recent diagnosis epilepsy
* Able to describe their symptoms by themselves
* Have had at least 2 episodes of seizures during the previous year
* Have had at least 1 headache during the previous year

Exclusion Criteria:

* Well-controlled epileptic patients taking anti-epileptic medications

Primary outcomes:
measure: Rate of seizure-related headache among epilepsy patients and its classification
timeFrame: At first visit (This study is cross-sectional)
Secondary outcomes:
measure: The pain intensity of seizure-related headache
timeFrame: At 1st visit
measure: The frequency of seizure-related headache
timeFrame: At 1st visit
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd.
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT05408468: Pilot Evaluation of FAMCOPE-ICU (Family Coping and Emotion Regulation Tool in the ICU)
Official title: Pilot Evaluation of FAMCOPE-ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation
Coping Skills
Keywords: Critical Care
Informal Caregiving
Surrogate Decision-Making
Self-Regulation
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-06-07
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Having a family member or loved one in the ICU can be a very stressful experience. The investigators have created a tablet-based tool (FAMCOPE-ICU) that is designed to help people in this position cope with this experience.


Eligibility criteria: Patient Inclusion Criteria:

* 18-89 years old
* Intensive Care Unit (ICU) length of stay (LOS) \>= 48 hours
* No anticipated ICU LOS for next 24 hours
* Unable to make healthcare decisions

Family Inclusion Criteria

* Identified by critical care team as legally authorized representative (LAR)
* Able to speak or comprehend English
* \>= 18 years old

Patient Exclusion Criteria:

* Less than 18 years or older than 89 years
* ICU LOS \< 48 hours
* Anticipated ICU discharge within next 24 hours
* Able to make healthcare decisions

Family Exclusion Criteria

* Not identified by critical care team as the LAR
* Unable to speak or comprehend English
* \< 18 years old

Primary outcomes:
measure: Acceptability of Intervention Measure
timeFrame: After dose 1, 5 minutes
measure: Acceptability of Intervention Measure
timeFrame: After dose 2, 5 minutes
measure: Acceptability of Intervention Measure
timeFrame: After dose 3, 5 minutes
Secondary outcomes:
measure: Change in Anxiety as Measured by PROMIS Anxiety Short Form
timeFrame: Baseline (enrollment), one week.
measure: Change in Depression as Measured by PROMIS Depression Short Form
timeFrame: Baseline (enrollment), one week.
measure: Sleep Disturbance as Measured by PROMIS Sleep Disturbance Short Form
timeFrame: Baseline (enrollment)
measure: Decision Fatigue Scale
timeFrame: One week post-enrollment
measure: Decisional Conflict Scale
timeFrame: One week post-enrollment
measure: Satisfaction as Measured by the Family Satisfaction in the Intensive Care Unit Scale - 24R
timeFrame: One week post-enrollment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Seth A Hoffer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Grant A Pignatiello, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00733668: Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder
Official title: An Open-Label, Non-Comparative, Multi-Centre, Phase II Prospective Trial to Assess the Efficacy of Quetiapine Fumarate Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) in SSRI-Resistant Major Depressive Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: considered
entry
into
the study
SSRI
Seroquel
Quetiapine
fumarate
antipsychotic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, non-comparative, multi-centre, phase II prospective trial to assess the efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors (SSRIs) in SSRI-resistant major depressive disorder.


Eligibility criteria: Inclusion Criteria:

* Inform consent
* Male and female, age between 18 and 65 years.
* Naïve to any atypical antipsychotic
* A diagnosis of major depressive disorder

Exclusion Criteria:

* No use of fluvoxamine
* Patients with a history of bipolar I or II disorder
* Diagnosis of psychotic major depression disorder

Primary outcomes:
measure: The Montgomery-Asberg Depression Scale (MADRS) score
timeFrame: Visit 1 - > 5
Secondary outcomes:
measure: The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs)
timeFrame: Visit 1 - > 5 (1 week between each visit)
measure: Sheehan Disability Scale (SDS) score
timeFrame: Visit 1 - > 5 (1 week between each visit)
measure: The Symptom Checklist 90 Revisred (SCL-90-R) score
timeFrame: Visit 1 - > 5 (1 week between each visit)
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Sint-Truiden
country: Belgium
facility: Research Site
Study officials:
affiliation: KUL
name: Pr. Demyttenaere
role: STUDY_DIRECTOR
References:
Clinical trial NCT04608968: Pediatric Perioperative Satisfaction Questionnaire
Official title: Development and Validation of a Perioperative Satisfaction Questionnaire in Children Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perioperative
Children
Satisfaction
Keywords: Validity
Questionnaire
Children
health quality of life
Self report
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 600
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children 7 years and older after surgery

Brief summary: The aim of this study is to develop and validate a self-report questionnaire to evalutate the satisfaction of the children after surgery.

Detailed description: Step 1 : development of the questiontionnaire Face to face interview to report the satisfaction of the children after surgery and to identify recurrent themes to generate questions.

Step 2 : validation of the questionnaire Evaluation of the psychometric validity of the final questionnaire

Eligibility criteria: Inclusion criteria:

* children 7 years and older
* elective surgery
* general anesthesia
* abiliy to understand and read questions

Exclusion criteria:

* emergency
* cognitive trouble
* intellectual disability

Primary outcomes:
measure: Children satisfaction after surgery
timeFrame: at discharge of hospital ( from the day of surgery up 14 days)
Secondary outcomes:
measure: postoperative pain intensity
timeFrame: at discharge of hospital ( from the day of surgery up 14 days)
measure: perioperative anxiety level
timeFrame: at discharge of hospital ( from the day of surgery up 14 days)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: UH Bordeaux
city: Grenoble
country: France
facility: UH Grenoble
city: Montpellier
country: France
facility: Uhmontpellier
city: Nîmes
country: France
facility: UH Nîmes
city: Reims
country: France
facility: UH Reims
city: Toulouse
country: France
facility: UH Toulouse
Study officials:
affiliation: University Hospital, Montpellier
name: Christophe DADURE, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06899568: Finite Element and z Shap Mini Plate With Lingual Extension
Official title: Finite Element Evaluation of Patient Specific Z-shaped Plate With Lingual Extension Versus Conventional Two Mini Plates for Mandibular Parasymphyseal Fracture Fixation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mandible Fracture
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * A cone beam CT (CBCT) scan of the patient, will be used to create a 3D scanned image of parasympheseal mandibular fracture
* 3D images will be introduced to finite element (FA)software to evaluate Stresses (MPa) and Life time (cycle) For each model and determine which plate is the best


Eligibility criteria: Inclusion Criteria:

- parasymhyseal fracture

Exclusion Criteria:

• absence of other facial trauma, mandibular condylar fracture

Primary outcomes:
measure: stress on the plate will be measured for each point of application by finite element (FA) software
timeFrame: immediate after the procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01243268: A Regulatory Requirement Post-Marketing Surveillance Study to Monitor the Safety and Efficacy of Twynsta (Telmisartan + Amlodipine SPC, q.d.) in Korean Hypertensive Patients Requiring Combination Therapy
Official title: A Regulatory Requirement Post-Marketing Surveillance Study to Monitor the Safety and Efficacy of Twynsta (Telmisartan + Amlodipine SPC, q.d.) in Korean Hypertensive Patients Requiring Combination Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-11-18
Enrollment: 674
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean patients wtih essential hypertension

Brief summary: This is a prospective, observational, open-label, multi-center study, which will provide detailed information about the safety and efficacy of Twynsta tablets in Korean hypertensive patients requiring combination therapy. This will present a convenient treatment option for hypertension in Korean patients.

Detailed description: Study Design:

PMS Observational study

Eligibility criteria: Inclusion criteria:

No specific inclusion and exclusion criteria will be provided due to the exploratory character of the study. Patients who have initiated Twynsta tablets according to the recommended and approved usage in Korea will be consecutively enrolled.

Exclusion criteria:

No specific inclusion and exclusion criteria will be provided due to the exploratory character of the study. Patients who have initiated Twynsta tablets according to the recommended and approved usage in Korea will be consecutively enrolled.

Primary outcomes:
measure: Percentage of Subjects With Adverse Events
timeFrame: Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)
Secondary outcomes:
measure: Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) < 140/90 mmHg)
timeFrame: 8±2 weeks
measure: Percentage of Subjects Who Achieved DBP Response (Defined as Mean Sitting DBP < 90 mmHg or a Reduction of Over 10 mmHg)
timeFrame: 8±2 weeks
measure: Percentage of Subjects Who Achieved SBP Response (Defined as Mean Sitting SBP < 140 mmHg or a Reduction of Over 10 mmHg)
timeFrame: 8±2 weeks
measure: Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg.
timeFrame: 8±2 weeks
Other outcomes:
Locations:
city: One Or Multiple Sites
country: Korea, Republic of
facility: NISND Center
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: