louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02818153: Validation of an Allergic Rhinitis Control Test in Teenagers
Official title: Validation of an Allergic Rhinitis Control Test in Teenagers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in adolescents or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitsis (ARCT) in patients from 12 years of age. However, this study included only 67 adolescents aged 12 to 17 years old and lacked power.

In this new study,the investigators propose, following exactly the same procedure as the pilot study of 2008, to confirme the validation of unmodified Adult questionnaire in adolescents 12 to 17 years inclusive.


Eligibility criteria: Inclusion Criteria:

* Patients aged 12 to 17 years old, consulting a practitioner for an allergic rhinitis
* parents formulated their study participation agreement by signing the consent form.

Exclusion Criteria:

* Patients that are already treated for the actual episode of allergic rhinitis and are satisfied of the treatement.

Primary outcomes:
measure: Score of the allergic rhinitis control self questionnaire in teenagers from 12 to 17 years old.
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
References:
Clinical trial NCT02793453: Antimicrobial Peptides in Periodontitis
Official title: Antimicrobial Peptides in Periodontitis : a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Disease : Chronic Periodontitis
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 29
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Periodontal diseases are complex chronic pathologies presenting a high prevalence worldwide. Etiopathological process involved in initiation and progression of these multifactorial diseases are not well understood, explaining the huge clinical forms variability and the complexity of the currently used classification of periodontal diseases. Recently, the implication of antimicrobial peptides (AMPs) have been suggested as potential track of explanation for periodontal diseases pathogeny. The here presented study explore the level of expression of genes coding those peptides by studying periodontal smears obtained from healthy and periodontitis patients.

Detailed description: This study explore the level of expression of genes coding those peptides by studying Messenger RNA (mRNA) purified from periodontal smears obtained from healthy and periodontitis patients by "Masterpure©" protocol.After reverse transcription (RT-PCR), in-silico design of primers and specificity and efficiency calculation, Complementary DNA (cDNA) are quantified by a semi-quantitative method (delta-delta CT) vs a Housekeeping gene. Wilcoxon-Mann \& Whitney tests and Chi² tests are performed to check the significativity of the results between groups.

Eligibility criteria: Inclusion Criteria:

* Patients suffering of moderate to severe chronic periodontitis as described by the classification Armitage-1999, aged 35-65yo

Exclusion Criteria:

* Pregnant females, patients suffered from any other systemic diseases (cardiovascular, pulmonary, liver, cerebral, diseases or diabetes, cancer)
* patients that had received antibiotic treatment in the previous 3 months or who were taking long-term anti-inflammatory drugs; who had received a course of periodontal treatment or orthodontics treatment within the last 6 months; who were heavy smokers (\>5 cig/day)

Primary outcomes:
measure: Antimicrobial peptides expression levels
timeFrame: Day 0
Secondary outcomes:
measure: mRNA quantity
timeFrame: Day 0
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT02785653: Effect of Sevoflurane on the Onset Characteristics and Intubating Conditions of Rocuronium
Official title: Effect of Sevoflurane on the Onset Characteristics and Intubating Conditions of Rocuronium Under Routine Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Relaxation Caused by Sevoflurane
Keywords: sevoflurane
rocuronium
intubation
Lead sponsor: Maharashtra University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Jaslok Hospital and Research Centre
First posted: 2016-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the potentiation of muscle relaxation caused by rocuronium by inhalational agent sevoflurane. Half the patients will be ventilated with oxygen ,nitrous oxide and sevoflurane during induction of anaesthesia and half will be ventilated only with oxygen and nitrous oxide.

Detailed description: Rocuronium is a non depolarizing muscle relaxant. Inhalational general anaesthetic agents like Sevoflurane have some muscle relaxation effect by depressing the spinal motor neurons. Inhalational anaesthetics also alter the tonic input received from descending modulatory systems from the brain. Deep anaesthesia with inhalational agents may cause some degree of neuromuscular blockade.

Eligibility criteria: Inclusion Criteria:

* American society of anaesthesiologists physical status 1 and 2
* Age between 18-65
* Mallampatti classification 1 and 2

Exclusion Criteria:

* Patients refusal to participate
* American society of anaesthesiologists physical status 3 and 4
* Mallampatti classification 3 and 4
* Patients with neuromuscular disorder
* Patients on medications that affect neuromuscular block
* Pregnant and lactating patients

Primary outcomes:
measure: intubating condition
timeFrame: 10 minutes
Secondary outcomes:
measure: lag time
timeFrame: 10 minutes
measure: onset time for maximum relaxation
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Jaslok Hospital and Research Centre
state: Maharastra
Study officials:
affiliation: Lokmanya Tilak Municipal Medical College and Hospital
name: Nazmeen I Sayed, DNB(Anaes)
role: PRINCIPAL_INVESTIGATOR
affiliation: Jaslok Hospital and Research Centre
name: Dipankar Dasgupta, MD(Anaes)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05961553: Effect of an Individual Counseling Session on Physical Activity Level of Individuals With COPD
Official title: Effect of an Individual Counseling Session on Physical Activity Level of Individuals With Chronic Obstructive Pulmonary Disease (COPD) - Randomized Controlled Study (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
Pulmonary Rehabilitation
Physical Activity
Counseiling Session
Exercise
Lead sponsor: Polytechnic Institute of Porto
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized clinical trial is to study the effect of an individual counseling session on the level of physical activity and motivation to practice physical exercise in individuals with COPD. The main question\[s\] it aims to answer are:

• Does a counseling session improve the level of physical activity and motivation to practice physical exercise in individuals with COPD?

Participants will perform a respiratory rehabilitation program (Control Group, CG) and a respiratory rehabilitation program and the counseling session (Experimental Group, EG).

Researchers will compare EG to CG to see if there is any difference in physical activity level and motivation to exercise between groups.


Eligibility criteria: Inclusion Criteria:

* Portuguese nationality;
* Medical diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD 2022);
* Aged over 40 years.

Exclusion Criteria:

* underwent recent orthopedic surgeries (\<3 months);
* Pregnant;
* Terminal illness diagnosis (life expectancy of less than 6 months);
* High cardiovascular risk classification for the practice of physical activity according to American College of Sports Medicine (ACSM 2018).

Primary outcomes:
measure: Average Daily Steps
timeFrame: 7 days
measure: Light Physical Activity
timeFrame: 7 days
measure: Moderate Physical Activity
timeFrame: 7 days
measure: Vigorous Physical Activity
timeFrame: 7 days
measure: Sedentary Activity
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Figueira Da Foz
country: Portugal
facility: Hospital Distrital da Figueira da Foz, EPE
state: Coimbra
Study officials:
affiliation: Escola Superior de Saúde
name: Tiago Pastilha, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Escola Superior de Saúde
name: Ana Alexandrino, PhD
role: STUDY_DIRECTOR
affiliation: Escola Superior de Educação
name: Susana Vale, PhD
role: STUDY_DIRECTOR
affiliation: Escola Superior de Saúde
name: Rui Macedo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01226953: Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants
Official title: A Phase III Observer Blind Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of Vaxem™ Hib to HIBERIX® When Given as Part of a Local Dosing Regimen in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilus Influenzae Type b (Hib) Infection
Keywords: Haemophilus influenzae type b (Hib)
Vaccine
Anti-PRP antibody
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-10-22
Enrollment: 660
Sex: ALL
Minimum age (years): 365
Maximum age (years): 569
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety and immunogenicity of booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age


Eligibility criteria: Inclusion Criteria:

* Infants 365-569 days of age.

Exclusion Criteria:

* Subjects who already received a booster dose of Hib vaccine.
* History of serious reaction(s) following vaccination.
* Any vaccination within 7 days of study vaccination.
* Known or suspected immune impairment.

Primary outcomes:
measure: Anti-PRP (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination
timeFrame: 30 days after last vaccination
Secondary outcomes:
measure: Solicited local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs)
timeFrame: 30 days post last vaccination
Other outcomes:
Locations:
city: Hebei Province
country: China
Study officials:
References:
citation: Jun L, Yuguo C, Zhiguo W, Jinfeng L, Huawei M, Xiuhua L, Yonggui Z, Yanhua X, Kong Y, Hongtao L, Yuliang Z. Assessment of immunogenicity and safety following primary and booster immunisation with a CRM197 -conjugated Haemophilus influenzae type B vaccine in healthy Chinese infants. Int J Clin Pract. 2013 Oct;67(10):971-8. doi: 10.1111/ijcp.12267. Epub 2013 Aug 22.
Clinical trial NCT05182853: Voiding Disorders in Children After Sacrococcygeal Teratoma Resection
Official title: Voiding Disorders in Children After Sacrococcygeal Teratoma Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sacrococcygeal Teratoma
Neurogenic Bladder
Voiding Disorders
Keywords: Teratoma
sacrococcygeal region
urinary incontinence
neurogenic bladder
children
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 8
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent surgical treatment of a sacrococcygeal teratoma, without ano rectal malformation or any other neurological pathology

Brief summary: Sacrococcygeal teratomas are the most common neonatal tumors and require rapid and complete resection. Tumor nerve compression and pelvic surgical sequelae may lead to many and varied voiding disorders. Data concerning long-term vesico-sphincteric disorders are conflicting. Some studies find good functional results \[Cozzi et al., 2008; Draper et al., 2009\]. However other authors reveal neurologic bladder with detrusor sphincter dyssynergia \[Hambraeus et al., 2018\] and rise concerned about long-term renal function \[Khanna et al., 2019; Rehfuss et al., 2020\] even in the absence of clinical voiding disorders. Most of studies include young patients with other malformations such as anorectal malformations or dysraphisms which may impact the results. The main objective is to assess bladder dysfunction in children aged 6 to 18 years after isolated sacrococcygeal teratoma resection.


Eligibility criteria: Inclusion criteria:

* Children aged 6 to 18
* history of sacrococcygeal teratoma resection

Exclusion criteria:

* Associated anorectal malformation
* Associated neurological pathology

Primary outcomes:
measure: Presence of voiding disorders
timeFrame: Day 1
Secondary outcomes:
measure: Presence of defecation disorders
timeFrame: Day 1
measure: Presence of secondary neurological bladder
timeFrame: Day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Sarah GARNIER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03885453: Construction of a Questionnaire on Panic Disorder and Agoraphobia
Official title: Construction of a Questionnaire on Panic Disorder and Agoraphobia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Panic Disorder
Panic Disorder With Agoraphobia
Agoraphobia
Agoraphobia With Panic Attacks
Depression
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Panic Disorder / Agoraphobia / Depression

Brief summary: For the first time panic disorder and agoraphobia are included as separate disorders in the DSM-5. Thus, agoraphobia no longer represents a subcategory of panic disorder. To diagnose both of the disorders, questionnaires are the method of choice. However, there are no measuring instruments available free of charge in German-speaking countries. In order to improve this situation, the Witten Panic Disorder Questionnaire (WPF) and the Witten Agoraphobia Questionnaire (WAF) are constructed in accordance with the DSM-5 criteria. Both measuring instruments are included as a part of a ten instrument battery. WAF and WPF will be delivered to a patient sample of patients with panic disorder and/or agoraphobia as well as depressed patients (discriminant validity). Factor analyzes and item analyses will be conducted.


Eligibility criteria: Inclusion Criteria:

Panic Disorder / Agoraphobia / Depression diagnosis via diagnostic interview

Exclusion Criteria:

-

Primary outcomes:
measure: Wittener Panik Fragebogen (WPF)
timeFrame: 5 min
measure: WAF
timeFrame: 10 min
Secondary outcomes:
measure: Agoraphobic Cognition Questionnaire (ACQ)
timeFrame: 5 min
measure: Body Sensations Questionnaire (BSQ)
timeFrame: 5 min
measure: Mobility Inventory (MI)
timeFrame: 10 min
measure: Agoraphobic Self-Statements Questionnaire (ASQ)
timeFrame: 5 min
measure: Agoraphobic Cognitions Scale - extended version (ACS+)
timeFrame: 5 min
measure: Patient Health Questionnaire - D (PHQ-D) - Subscale Panic Syndrome
timeFrame: 5 min
measure: Brief Symptom Inventory (BSI)
timeFrame: 10 min
measure: Beck Depression Inventory (BDI)
timeFrame: 10 min
Other outcomes:
Locations:
city: Witten
country: Germany
facility: Witten/Herdecke University
state: North Rhine-Westphalia
Study officials:
References:
Clinical trial NCT00005753: Pharmacological and Behavioral Treatment of Insomnia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Sleep
Sleep Initiation and Maintenance Disorders
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: to develop the maximally effective treatment strategy for chronic sleep-onset insomnia and to reduce its impact on psychological functioning, health, and economic sequelae.

Detailed description: DESIGN NARRATIVE:

The study examined the relative efficacy of a pharmacologic, cognitive behavioral, and conjoint pharmacological/behavioral intervention for chronic sleep-onset insomnia. Sixty-three medication-free, chronic sleep-onset insomniacs completed evaluations, baseline sleep diaries, daytime functioning and mood inventories and home-based objective sleep assessments (OSA). Subjects were then randomized to one of four interventions: 1) six week Zolpidem intervention (D for drug); 2) six week multifactor behavioral intervention (B for behavioral); 3) six week conjoint Zolpidem and multifactor behavioral intervention (DB); and 4) placebo medication intervention (P for placebo). The main outcome measures were sleep-onset latency as measured by sleep diaries; secondary measures included sleep diary measures of sleep efficiency and total sleep time, objective measures of sleep variables (Nightcap sleep monitor recorder), and measures of daytime functioning.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Gregg Jacobs
References:
citation: Jacobs GD, Pace-Schott EF, Stickgold R, Otto MW. Cognitive behavior therapy and pharmacotherapy for insomnia: a randomized controlled trial and direct comparison. Arch Intern Med. 2004 Sep 27;164(17):1888-96. doi: 10.1001/archinte.164.17.1888.
Clinical trial NCT02003053: A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU
Official title: A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill
Respiratory Failure
Keywords: Critically ill
intubated
safety
feasibility
inspiratory muscle training
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Inspiratory muscle training (IMT) is an intervention used with success in the outpatient setting within the COPD population. Use of IMT is also theoretically possible during mechanical ventilation. This study will will assess the feasibility and safety of the study of IMT in the patient population.


Eligibility criteria: Inclusion Criteria:

* Mechanically ventilated patients.
* Must have passed spontaneuos brething trial screening but failed the trial itself.
* Potential subject must be able to perform atleast 5 minutes of spontaneous breathing trial.

Exclusion Criteria:

* Known neuromuscular disease
* Unstable cardiac ischemia
* Tracheostomized patients

Primary outcomes:
measure: Safety and Feasibility of Inspiratory Muscle Training
timeFrame: Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Peter E Morris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05574153: Metabolic Risk Factors and Myocardial Oxygenation Reserve
Official title: Metabolic Risk Factors and Myocardial Oxygenation Reserve (META-MORE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic Syndrome
Keywords: Myocardial oxygenation
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of participants with known MetS, based on the identified risk factors, and healthy volunteers.

Brief summary: The purpose of this study is to use MRI images using the OS-CMR technique to view the differences in the hearts of healthy volunteers and participants with a condition called Metabolic Syndrome. The objectives of this project are to compare these two groups and to view how health risks, blood test results, and the time since a Metabolic diagnosis can affect heart health.

Detailed description: Myocardial oxygenation changes during vasoactive breathing maneuvers, observed with oxygenation-sensitive cardiac MRI, will be identified and compared between individuals considered healthy and those fitting the criteria of the Metabolic Syndrome.

Eligibility criteria: Inclusion Criteria:

Patient Participants:

* Age 18-80
* Informed Consent
* Diagnosis of MetS (through at least 3 MetS characteristics (abdominal obesity, high triglyceride level, low HDL cholesterol, high systolic blood pressure, and high fasting glucose levels)

Healthy Volunteers:

* Age 18-80
* No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system
* No Smoking

Exclusion Criteria:

* General MRI contraindications\*
* Pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, knowledge or suspicion of pregnancy.
* Consumption of caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 hours prior to the exam

Primary outcomes:
measure: Global and segmental Myocardial oxygenation reserve (MORE)
timeFrame: Baseline
measure: Relation between Breathing maneuver induced MORE and known MetS risk factors.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: The Reseach Institute of the McGill University Health Centre
state: Quebec
Study officials:
References: