louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05755126: Efficacy of Iatrosedation and Music Therapy to Attenuate Dental Anxiety
Official title: The Comparative Efficacy of Iatrosedation and Music Therapy as Techniques to Attenuate Dental Anxiety in Patients Undergoing Dental Crown Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Altamash Institute of Dental Medicine
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dental anxiety is a common problem encountered in the dental clinics that affect both patients and dentists. Adequate management of the dental anxiety is critical for optimal treatment outcomes of the patient. In this clinical trial, a total of sixty patients were randomly assigned to three groups as follows: Group 1, Iatrosedation, Group 2, Music Therapy, and Group 3, Control. Patients in all of the three groups underwent dental crown preparation. . To measure the anxiety levels of the patients, heart rate was measured using a pulse oximeter, and verbal rating scale scores were assessed

Detailed description: Dental anxiety is a common problem encountered in the dental clinics that affect both patients and dentists. Adequate management of the dental anxiety is critical for optimal treatment outcomes of the patient.

This study aims to assess the efficacy of different anxiety reduction techniques (Iatrosedation and music therapy) in adult patients for dental crown preparations.

In this clinical trial, a total of sixty patients were randomly assigned to three groups as follows: Group 1, Iatrosedation, Group 2, Music Therapy, and Group 3, Control. Patients in all of the three groups underwent dental crown preparation. To measure the anxiety levels of the patients, heart rate was measured using a pulse oximeter, and verbal rating scale scores were assessed. One-way ANOVA, Post hoc, and Spearman's correlation was used to compare the mean values of the three groups.

Eligibility criteria: Inclusion Criteria:

* patients who were above 18 years of age
* no systemic diseases
* no previous dental treatment experience
* showed willingness to participate

Exclusion Criteria:

* patients below the age of 18 years
* medically compromised
* previous history of dental treatment

Primary outcomes:
measure: Dental Anxiety
timeFrame: 6 months
measure: Dental Anxiety
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Altamash Institute of Dental Medicine
state: Sindh
Study officials:
References:
Clinical trial NCT02336126: Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Chronic Fatigue Syndrome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study of a biopsychological intervention program for adolescent chronic fatigue syndrome. The program is related to cognitive behavioral therapy, which has been proven beneficial in this disorders, but includes other mental techniques, such as emotional control and metacognitive elaboration.

The aim of this pilot study is to explore a) patients' experiences and b) possible positive effects on symptoms. We hypothesise that the intervention will be regarded feasible by the patients, and that fatigue score will improve during the intervention period.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic fatigue syndrome
* Significant school absenteeism
* Above 12 years of age and below 18 years of age

Exclusion Criteria:

* Other diseases or life events that might explain chronic fatigue
* Bed-ridden

Primary outcomes:
measure: Chalder fatigue score
timeFrame: Up to 3 months after inclusion
Secondary outcomes:
measure: Patients' experiences (semistructured interview)
timeFrame: Up to 3 months after inclusion
measure: Quality of Life (PedsQL)
timeFrame: Up to 3 months after inclusion
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus university hospital
state: Akershus
Study officials:
References:
Clinical trial NCT01509326: Chiropractic and Acupressure for Headaches
Official title: A Randomized Clinical Trial of Chiropractic Care for Headaches With and Without an Acupressure Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cervicogenic Headache
Tension-type Headache
Migraine Headache
Keywords: headache
chiropractic
manipulation
acupressure
self-care
Lead sponsor: Canadian Memorial Chiropractic College
Sponsor class: OTHER
Collaborators: name: Dr. Zaxx Co.
First posted: 2012-01-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effect of chiropractic treatment with and without the use of an acupressure pillow for cervical headaches. Subjects will be randomly allocated to groups with and without the pillow and will be followed for five weeks. The primary outcome measure will be headache frequency. The investigators predict that the group using the pillow on a daily basis will demonstrate significantly greater decrease in headache frequency over a 5-week interval.


Eligibility criteria: Inclusion Criteria:

* males and females
* ages 21-60
* recurrent headaches
* sub-occipital tenderness
* a minimum of 4 headaches per month

Exclusion Criteria:

* migraine with aura
* sinus headache
* any other organic pathology
* any contraindications to cervical manipulation

Primary outcomes:
measure: Headache frequency from a Headache Diary
timeFrame: change from baseline in headache frequency at 5 weeks
Secondary outcomes:
measure: Headache disability
timeFrame: baseline / end of treatment (5 weeks)
measure: Treatment satisfaction
timeFrame: end of treatment (5 weeks)
measure: Adverse events
timeFrame: up to five weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Canadian Memorial Chiropractic College
state: Ontario
Study officials:
References:
citation: Vernon H, Jansz G, Goldsmith CH, McDermaid C. A randomized, placebo-controlled clinical trial of chiropractic and medical prophylactic treatment of adults with tension-type headache: results from a stopped trial. J Manipulative Physiol Ther. 2009 Jun;32(5):344-51. doi: 10.1016/j.jmpt.2009.04.004.
Clinical trial NCT06698926: A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants
Official title: A Phase 1 First in Human, Single and Multiple Ascending Dose, Food Effect, and Drug-Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-CLS-616
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
ABBV-CLS-616
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Calico Life Sciences LLC
First posted: 2024-11-21
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, first in human, randomized, four-part study to investigate the safety, tolerability, and pharmacokinetics of ABBV-CLS-616 after oral dosing in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Part 2 only: Participant must have normal platelet count at screening and upon initial confinement.
* Part 2 only: Participant must not have known or suspected coagulopathy, or prothrombin time (PT)/activated partial thromboplastin time (aPTT)/international normalized ratio (INR) values outside of normal range at screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, neurological examination, ophthalmic examination (Part 2 only) laboratory profile and a 12-lead Electrocardiogram.

Exclusion Criteria:

* Part 2 only: Clinically significant active or recurrent ocular disease.
* History of lumbar puncture and/or collection of cerebrospinal fluid within 30 days prior to Screening.
* History of current condition of chronic lower back pain.
* Evidence of conditions that might preclude the subject from undergoing a lumbar puncture.
* History: of clinically significant neurological epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, coagulopathy, or any uncontrolled medical illness.
* History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale completed at Screening, or any history of suicide attempts within the last two years.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 270532
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06765226: Impella Pump Return Study to Analyze Deposits and Biomaterial in Used Pumps
Official title: Abiomed Impella Pump Return Registry - Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Impella CP or Impella 5.5 heart pump due to severe acute heart failure by any cause (e.g. cardiogenic shock in acute myocardial infarction, cardiac arrest, myocarditis or in relation to cardiac surgery).

Brief summary: Analysis of cell and protein deposits on the Impella Heart Pump.

Detailed description: The Impella heart pump supports patients in cardiogenic shock for various reasons and has passed safety and biocompatibility evaluations. The planned investigation aims to further analyze cell and protein adhesion on these pumps and the effects of their prolonged use, especially in scenarios like bridge-to-transplant, recognizing preclinical testing limitations.

Eligibility criteria: Inclusion Criteria:

* Patients with Impella 5.5 therapy and duration of support for ≥ 25 days OR Patients with Impella CP therapy and duration of support for \> 4 days
* Use of Sodium Bicarbonate as a purge additive as permitted by the IFU

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Investigate deposits and biomaterial after use of pump
timeFrame: through study completion, at least 5 days
measure: Investigate deposits and biomaterial after use of pump
timeFrame: through study completion, at least 25 days
Secondary outcomes:
measure: Relation deposits and biomaterial to clinical events
timeFrame: through study completion, at least 5 days
measure: Relation deposits and biomaterial to clinical events
timeFrame: through study completion, at least 25 days
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Herzzentrum Dresden
state: Saxony
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité Berlin
Study officials:
affiliation: Deutsches Herzzentrum der Charité
name: Pia Lanmüller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03179826: Analysis of Inhaled Corticoid Prescriptions in General Medicine
Official title: Analysis of Inhaled Corticoid Prescriptions in General Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is composed of adults consulting with one of the participating general practitioners and requiring long term inhaled corticoids and monitoring.

Brief summary: Chronic obstructive pulmonary disease (COPD) and asthma are frequent and disabling pathologies. The general practitioner is often at the front line vis-a-vis screening, diagnosis and treatment of these pathologies. There are currently many treatments available, in particular inhaled corticosteroids, and although the recommendations for management appear to be well codified in theory, the adaptation of drug therapy remains complex in general practice.

The prescription of inhaled corticosteroids, often initiated during a general medicine consultation, is not simple. The aim of this study is to analyze the relevance of the prescription of inhaled corticosteroids in primary care and to identify the criteria necessary for the prescription of inhaled corticosteroids available in general practice.

The main objective of our study is to evaluate the rate of consultations where all the elements required for guiding the prescription of an inhaled corticoid are available.

The secondary objectives are:

* Identify other factors associated with decision-making
* Identify the causes of inhaled corticosteroid stopping (de-prescription)


Eligibility criteria: Inclusion Criteria:

* Patient with short-term inhaled corticosteroid therapy
* Informed and not opposed to participate in this research

Exclusion Criteria:

* Patient under judicial or legal protection
* Adults under any kind of guardianship -

Primary outcomes:
measure: Presence of all factors justifying the prescription of inhaled cortcoids
timeFrame: Day 0 (transversal study)
Secondary outcomes:
Other outcomes:
Locations:
city: Clapiers
country: France
facility: Cabinet de médecine générale
city: St Martin de Londres
country: France
facility: Cabinet de médecine générale
Study officials:
affiliation: Montpellier University Hospitals
name: Arnaud Bourdin, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00540826: Treatment Compliance in Children and Adolescents on ADHD Medication
Official title: Treatment Adherence and Compliance in Children and Adolescents on ADHD Medication and Emotional Expression in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ADHD
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 518
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents who are newly initiated on medication approved for the treatment of ADHD in a routine clinical setting.

Participating physicians may be office or hospital based psychiatrists and pediatricians throughout Germany.

Brief summary: The primary research objective of this observational study is to evaluate treatment compliance over one year in children and adolescents who are newly initiated on medication approved for the treatment of ADHD in a routine clinical setting. Compliance will be assessed using the Pediatric Compliance Self-Rating (PCSR) Instrument. A patient will be considered as compliant at a given visit, if the PCSR score is at least 5, corresponding to taking the medication at least often.


Eligibility criteria: Inclusion Criteria:

* 6-17 years old
* diagnosis of ADHD according to ICD-10 or DSM-IV criteria
* new initiation onto an approved medication to treat ADHD

Exclusion Criteria:

* no specific exclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Homburg
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-615-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Dittmann RW, Banaschewski T, Schacht A, Wehmeier PM. Findings from the observational COMPLY study in children and adolescents with ADHD: core symptoms, ADHD-related difficulties, and patients' emotional expression during psychostimulant or nonstimulant ADHD treatment. Atten Defic Hyperact Disord. 2014 Dec;6(4):291-302. doi: 10.1007/s12402-014-0136-z. Epub 2014 Apr 6.
Clinical trial NCT01627626: Effect of 0.1% Pilocarpine Mouthwash on Xerostomia
Official title: Effect of 0.1% Pilocarpine Mouthwash on Xerostomia : Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Keywords: xerostomia
pilocarpine mouthwash
minor salivary gland secretion
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the effect of 0.1% pilocarpine mouthwash on subjective dryness, minor salivary flow rates and unstimulated whole salivary flow rate in xerostomic patients.


Eligibility criteria: Inclusion Criteria:

* xerostomia for 3 months or more, and
* adults aged 20 years and older.

Exclusion Criteria:

* acute asthma attack
* acute iritis
* narrow angle glaucoma
* pilocarpine allergy
* pregnancy
* lactating women, and
* person who was treating xerostomia with artificial saliva, pilocarpine, or etc.

Primary outcomes:
measure: Change from baseline in minor salivary flow rates at 60 minutes
timeFrame: before and after using the mouthwash (baseline, immediately, 30 minutes, 60 minutes)
Secondary outcomes:
measure: Change from baseline in the severity of oral dryness at 60 minutes
timeFrame: Before and after using mouthwash (baseline, immediately, 30 minutes, 60 minutes)
measure: Change from baseline in the unstimulated whole salivary flow rates at 60 minutes
timeFrame: Before and after using mouthwash (baseline, 60 minutes)
measure: Change from baseline in the severity of oral dryness, minor salivary flow rates, and the unstimulated whole saliva flow rate at 4 weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Dental Hospital
Study officials:
affiliation: Yonsei University Dental Hospital
name: Jeong-Seung Kwon, DDS,MSD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02637726: Bispectral Index Under Propofol Anesthesia in Children : a Study Between TIVA and TCI
Official title: Bispectral Index Under Propofol Anesthesia in Children : a Comparative Randomised Study Between TIVA and TCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Total intravenous anesthesia
Target Controlled Infusion
Propofol
Bispectral index
Children
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 66
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In children, only a few studies have compared different modes of propofol infusion during a total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values) between four modes of propofol infusion: titration of the infusion rate on clinical signs (TIVA0), titration of the infusion rate on the BIS (TIVABIS), target controlled infusion (TCI) guided by the BIS either with the Kataria model (TCI KBIS) or the Schnider model (TCI SBIS).

Methods: Children will be prospectively randomized into the 4 groups. In the TIVA0 group the anesthesiologist is blinded to the BIS. In each group, the percentage of time with adequate BIS values (45-55), the bias and imprecision will be calculated.


Eligibility criteria: Inclusion Criteria:

* weighting more than 15 kg;
* American Society of Anesthesiologists physical status I or II
* scheduled for middle ear surgery

Exclusion Criteria:

* cardiovascular, neurological, hepatic or renal impairment, if their body mass index was above 95th percentile or if they received any drug interfering with the central nervous system.

Primary outcomes:
measure: Percentage of time spent at adequate BIS values
timeFrame: from the beginning to the end of the anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'anesthesie Hopital Armand Trousseau
Study officials:
affiliation: Hôpital Armand Trousseau
name: Isabelle Constant, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04084626: PD1 Antibody and Lenalidomide as a Treatment for EBV-HLH or CAEBV
Official title: A Clinical Trial of Programmed Cell Death Protein 1(PD1) Antibody and Lenalidomide as a Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis or Chronic Active EBV Infection(CAEBV)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: EBV Infection
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study was a prospective one-arm clinical study, in which EBV-HLH/chronic active EBV infection patients were selected as the main subjects to evaluate the effect of PD-1 antibody and lenalidomide regimens on ebv-dna and safety.


Eligibility criteria: Inclusion Criteria:

1. Patients with CAEBV confirmed by 2016 Revised World Health Organization classification.
2. If the patient has previously suffered CAEBV-HLH, the HLH should be in remission.
3. A woman of childbearing age must be determined not to be pregnant by a pregnancy test and is willing to take effective measures to prevent pregnancy during the trial period and ≥12 months after the last administration of the drug; All male subjects used contraceptive methods during the study period and ≥6 months after the last administration;
4. Ages Eligible for Study: 1 Year to 65 Years.
5. Sign the informed consent.

Exclusion Criteria:

1. Heart function above grade II (NYHA).
2. Pregnancy or lactating Women.
3. Allergic to PD-1 antibody or lenalidomide.
4. Active bleeding of the internal organs.
5. uncontrollable infection.
6. Participate in other clinical research at the same time.

Primary outcomes:
measure: Response rate
timeFrame: 6 months
Secondary outcomes:
measure: Spleen size
timeFrame: 6 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: through study completion, an average of 1 years
measure: survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
References: