louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01660867: Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department
Official title: Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Acute Bronchiolitis
Keywords: hospital admission within 7 days of 3% NaCl nebulizer vs dexamethasone
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, controlled, double-blinded, clinical trial

Subject : 3mo \~ 24mo. aged infants with bronchiolitis

The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.

Detailed description: Randomly assigned to one of three groups

* Group I : nebulized epinephrine + 0.9% saline + placebo
* Group II : nebulized epinephrine + 3% saline + placebo
* Group III : nebulized epinephrine + 0.9% saline + dexamethasone

Group I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral dexamethasone.

The primary outcome is hospital admission within 7 days after the day of enrollment

Eligibility criteria: Inclusion Criteria:

* 3mo \~ 24mo aged patients with bronchiolitis visit to emergency departments
* RDAI score 4-15

Exclusion Criteria:

* \< 3mo, \> 24mo
* infants who had received oral or inhaled corticosteroids during the preceding 2 weeks
* infants with a previous episode of wheezing or a diagnosis of asthma
* any chronic cardiopulmonary disease
* immunodeficiency
* infants needed intubation
* infants with a previous history of apnea or intubation
* infants with side effect of dexamethasone
* infants born at less than 37 weeks of gestation who had a corrected age of less than 6 weeks at presentation

Primary outcomes:
measure: hospital admission within 7 days after the day of enrollment
timeFrame: within 7 days
Secondary outcomes:
measure: RDAI score
timeFrame: baseline, between nebulizer, 60min, 120min, 180min, 240min
measure: respiratory rate
timeFrame: baseline, between nebulizer, 60min, 120min, 180min, 240min
measure: Heart rate
timeFrame: baseline, between nebulizer, 60min, 120min, 180min, 240min
measure: Oxygen saturation
timeFrame: baseline, between nebulizer, 60min, 120min, 180min, 240min
measure: unplanned revisit and admission rate after revisit
timeFrame: in 7days
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT03010267: DP-R213 Phase 1 Pharmacokinetics Study
Official title: An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Fixed Dose Combination of Raloxifen/Cholecalciferol Compared With Coadministration of Raloxifen and Cholecalciferol in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: DP-R213
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2017-01-05
Enrollment: 46
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* IBW ±20%
* Signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Previously donate whole blood within 2 months or component blood within 1 month
* Clinically significant allergic disease
* Taken IP in other trial within 3 months
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: up to 96 hours post dose
measure: Peak Plasma Concentration (Cmax)
timeFrame: up to 96 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lee HW, Kang WY, Gwon MR, Choi EJ, Kim EH, Cho K, Lee B, Seong SJ, Yoon YR. A randomized, open-label, single-dose, two-way crossover study to assess the pharmacokinetics between two tablets of fixed-dose combination formulation with raloxifene and cholecalciferol and concomitant administration of each agents in healthy male volunteers. Transl Clin Pharmacol. 2022 Sep;30(3):136-144. doi: 10.12793/tcp.2022.30.e13. Epub 2022 Sep 15.
Clinical trial NCT01805167: Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients
Official title: Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Loss
Keywords: Subject with cochlear implant
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to quantify the influence of the electrical field interactions between the channels of stimulation according to the vocal performances of the implanted subjects, for various subjective levels of electric stimulation.


Eligibility criteria: Inclusion Criteria:

* Subject of French language
* Subject with a moderate bilateral sensorineural hearing loss, severe to profound
* Sensorineural hearing loss post-lingual (after onset of language acquisition)
* Subject paired with the implant Neurelec (Appendix 1) for more than 9 months
* Subject has received an appropriate setting under usual clinical follow-up
* Elderly 18 to 75 years
* Subject giving consent

Exclusion Criteria:

* Sensorineural hearing loss pre-lingual
* Deafness following a meningitis, or neurodegenerative diseases
* Illiteracy
* Pregnant women
* Subject blind
* Subject enjoying a measure of legal protection
* Subject incapable of giving consent
* Subject vulnerable

Primary outcomes:
measure: Quantify the interactions between electrical stimulation channels based vocal performance of implanted subjects, for different subjective levels of electrical stimulation.
timeFrame: At the inclusion - Day 0
Secondary outcomes:
measure: Comparative study of PEAEP (Auditory Evoked Potentials Early electric) in vocal performance
timeFrame: At the inclusion - Day 0
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Nicolas Guevara, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guevara N, Hoen M, Truy E, Gallego S. A Cochlear Implant Performance Prognostic Test Based on Electrical Field Interactions Evaluated by eABR (Electrical Auditory Brainstem Responses). PLoS One. 2016 May 5;11(5):e0155008. doi: 10.1371/journal.pone.0155008. eCollection 2016.
Clinical trial NCT06053567: Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.
Official title: Efficacy and Implementation of Exercise-based Smoking Cessation Treatment for Adults With High Anxiety Sensitivity.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nicotine Dependence
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: University of Houston
name: University of Oklahoma
name: National Cancer Institute (NCI)
name: YMCA
First posted: 2023-09-25
Enrollment: 360
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: Anxiety sensitivity, reflecting the fear of bodily sensations, is a risk factor for the maintenance and relapse of smoking. This study is designed to address the question - is a smoking cessation intervention personalized to high anxiety sensitive smokers and adapted for implementation by the YMCA effective among racially/ethnically diverse samples?

Detailed description: This protocol provides the recommended treatment to achieve smoking cessation (i.e., counseling and nicotine replacement therapy) and randomly assigns individuals to a high-intensity exercise or low-intensity exercise intervention as a strategy to engage the mechanisms relevant to high anxiety sensitive smokers to improve smoking cessation outcomes.

Eligibility criteria: Inclusion Criteria:

* Adult (age ≥ 18);
* High Anxiety Sensitivity (≥5 on the Short Scale Anxiety Sensitivity Index \[SSASI\]);
* Daily smoker, ≥5 cigarettes (including e-cigarettes, little cigars/cigarillos) for ≥1 year;
* Motivated to quit smoking as evidenced by a score of ≥5 on a 0-10 Likert scale;
* Body mass index \&lt;40;
* Medical clearance to participate.
* Located near a participating YMCA site (within 50 miles)

Exclusion Criteria:

* Regular exercise defined as engaging in vigorous-intensity exercise for at least 75 minutes per week for the last 3 months
* Receiving current intervention for smoking cessation.
* Outstanding debt to the YMCA
* Listed as a sex offender on the National Sex Offender Registry

Primary outcomes:
measure: 7-day point prevalence abstinence (PPA) at 6-month follow-up
timeFrame: Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6)
Secondary outcomes:
measure: 7-day point prevalence abstinence (PPA) at 12-month follow-up
timeFrame: Protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6)
measure: 7-day point prevalence abstinence (PPA) at 9-month follow-up
timeFrame: Protocol week 42, which is 36 weeks (9 months) after the quit attempt (set at week 6)
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Jasper Smits, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05410067: Cervicothoracic Junction Mobilization Versus Eccentric Muscle Energy Technique in Mechanical Cervical Pain
Official title: Effects of Cervicothoracic Junction Mobilization Versus Eccentric Muscle Energy Technique in the Treatment of Mechanical Cervical Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To compare the effectiveness of the cervicothoracic junction mobilization and eccentric muscle energy technique on mechanical cervical pain.
2. To compare the effectiveness of the cervicothoracic junction mobilization and eccentric muscle energy technique on cervical disability.
3. To compare the effectiveness of the cervicothoracic junction mobilization and eccentric muscle energy technique on cervical ROM.


Eligibility criteria: Inclusion Criteria:

* Participants falling in this category would be recruited into the study.

  1. Females
  2. Age between 18-45 years.
  3. Diagnosed with mechanical cervical pain.

Exclusion Criteria:

* Participant failing to fall in this category would be excluded of the study.

  1. Pregnant Females
  2. Any previous history of trauma or surgery
  3. Diagnosed with mechanical cervical pain due to disc herniation, radiculopathy or any other cervical malignancy.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 3 Weeks
measure: Neck Disability Index (NDI)
timeFrame: 3 Weeks
measure: Cervical Goniometer
timeFrame: 3 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah international University
state: ICT
Study officials:
affiliation: Riphah International University
name: Waqar Ahmad Awan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00704067: Improving Work Outcomes for Veterans With Traumatic Brain Injury
Official title: Improving Work Outcomes for Veterans With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: vocational rehabilitation
supported employment
cognitive training
cognitive remediation
cognitive rehabilitation
veterans
Lead sponsor: United States Department of Defense
Sponsor class: FED
First posted: 2008-06-24
Enrollment: 50
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 12-month study will investigate a cognitive training augmentation of supported employment to improve cognitive performance and work outcomes, which are expected to result in improved quality of life and community integration for veterans with mild to moderate traumatic brain injuries. The primary hypothesis is that compared to veterans who receive enhanced supported employment, those who receive supported employment plus cognitive training will work more weeks during the 12 months.


Eligibility criteria: Inclusion Criteria:

* OEF/OIF veteran
* History of mild-to-moderate TBI (loss of consciousness \<6 hours; post-traumatic amnesia \<7 days)
* Documented impairment in at least one neuropsychological domain
* Unemployed, but stating a goal of work
* Written informed consent to participate in the study

Exclusion Criteria:

* Current alcohol/substance abuse or dependence
* Participation in other intervention studies

Primary outcomes:
measure: Weeks worked
timeFrame: 12 months
Secondary outcomes:
measure: Hours worked
timeFrame: 12 months
measure: Dollars earned from working
timeFrame: 12 months
measure: Cognitive performance
timeFrame: 3, 6, and 12 months
measure: Neurobehavioral symptoms
timeFrame: 3, 6, and 12 months
measure: Quality of life
timeFrame: 3, 6, and 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: University of California, San Diego, VA San Diego Healthcare System, and Veterans Medical Research Foundation
name: Elizabeth W Twamley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walter KH, Jak AJ, Twamley EW. Psychiatric comorbidity effects on compensatory cognitive training outcomes for veterans with traumatic brain injuries. Rehabil Psychol. 2015 Aug;60(3):303-8. doi: 10.1037/rep0000049. Epub 2015 Jul 6.
Clinical trial NCT05605067: Genetic Architecture of Avoidant/Restrictive Food Intake Disorder
Official title: Genetic Architecture of Avoidant/Restrictive Food Intake Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARFID
Eating Disorders
Eating Disorders in Children
Eating, Picky
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Psychiatric Center Ballerup
First posted: 2022-11-04
Enrollment: 5076
Sex: ALL
Minimum age (years): 7
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of children with ARFID and adults with ARFID will self-select into the study. Because the study is conducted online, participants can join from across the United States

Brief summary: The goal of this observational study is to rapidly accelerate knowledge about the biology of avoidant and restrictive food intake disorder or ARFID in children ages 7-17 and in adults. The investigators will be evaluating the genetic and environmental origins of ARFID. Participants will be asked to answer questionnaires online and to submit a saliva sample for DNA using a kit that will be mailed to their home.


Eligibility criteria: Inclusion Criteria:

* Meet study criteria for ARFID
* Be willing to submit a saliva sample
* Have a US mailing address
* English-speaking

Exclusion Criteria:

* Potential other eating disorders

Primary outcomes:
measure: Case definitions
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Cynthia M Bulik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05646667: Interscalene Block Alone Versus Interscalene Block With Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia
Official title: Interscalene Block Alone Versus Interscalene Block With Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interscalene Block
Erector Spinae Plane Block
Shoulder Arthroscopy Anesthesia
Randomized Controlled Trial
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 50
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: OTHER

Brief summary: The aim of this study is to compare the effectiveness of interscalene brachial plexus block alone versus interscalene brachial plexus block +Erector spinae plane block in anesthesia for shoulder arthroscopy.

Detailed description: Regional anesthetic techniques can control pain effectively, both at rest and on movement, allowing earlier mobilization without the adverse effects of opioids . Among the various types of regional anesthetic techniques, the interscalene brachial plexus block is a gold standard used nerve block technique for postoperative analgesia in patients undergoing shoulder surgery, as it has consistently been shown to significantly control.

Eligibility criteria: Inclusion Criteria:

* Aged 18-65 years
* Both genders,
* BMI \< 40 kg/m2
* American Society of Anesthesiologists (ASA) physical status I-II
* Scheduled for elective shoulder arthroscopy.

Exclusion Criteria:

* Known allergy to local anesthetics,
* allergy to all opioid medications, diagnostic shoulder arthroscopic procedures,
* patients with chronic opioids,
* patients who converted to general anesthesia use and coagulopathy

Primary outcomes:
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperative up to 4 hours
Secondary outcomes:
measure: Amount of 24hrs postoperative rescue analgesic consumption
timeFrame: 24 hours postoperatively
measure: Degree of pain by Numerical pain rating scale
timeFrame: 24 hours postoperatively
measure: Time to first request of rescue analgesia.
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Islam Morsy
Study officials:
affiliation: Tanta University
name: Islam Morsy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00962767: Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission
Official title: A Randomized Study of Two Doses Gemtuzumab Ozogamicin vs. A Two-year Maintenance With Atra Plus Chemotherapy as Post-consolidation Treatment for Intermediate and High-risk Adult Patients With Acute Promyelocytic Leukemia (Apl)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Leukemia, Myelocytic, Acute
Keywords: Oncology comparison study
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-08-20
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL patients in achieving first hematological complete remission and molecular remission.


Eligibility criteria: Inclusion criteria:

1. Patients with untreated newly diagnosed and genetically proven APL (leukemic cells at diagnosis with the t(15;17) and/or the PML/RARα rearrangement by RT-PCR; the presence of additional cytogenetic lesions is not considered an exclusion criterion) with intermediate and high risk disease.
2. Male and female patients age \> 18 years and \< 61 years.

Exclusion criteria:

1. Low risk patients (WBC \< 10 x 109/L and platelets \> 40 x 109/L).
2. Absence of PML-RAR α rearrangement in leukemic cells after successful RNA extraction and amplification of control gene.
3. Pretreated APL.

Primary outcomes:
measure: The study will compare the 2 treatments in intermediate and high-risk APL patients and assess their efficacy in achieving first hematological complete remission and molecular remission.
timeFrame: 5 years
Secondary outcomes:
measure: Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival.
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: