louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02501122: Retrospective Analysis in Quality of Care Measures in Pediatric Adenotonsillectomy Patients
Official title: Cost Savings From Non-pharmacological Interventions for Pediatric Patients Undergoing Diagnostic Imaging at Nationwide Children's Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenotonsillectomy
Keywords: Quality
hospital care
adenotonsillectomy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 1000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone anesthesia for adenotonsillectomy, tonsillectomy or adenoidectomy during 2013-2015 at Nationwide Children's Hospital.

Brief summary: The purpose of this study is to interrogate the Partners for Kids (PFK) and the pediatric health information (PHIS) databases in addition to our own perioperative Nationwide Children's data base to look at outcomes, resource utilization, and cost trends for adenotonsillectomy in the nationally versus locally. The investigators also want compare Nationwide Children's to other regional and national tertiary pediatric institutions.


Eligibility criteria: Inclusion Criteria:

* Patients who undergone an adenotonsillectomy, tonsillectomy or adenoidectomy during the past 2 years (2013-2015) who have ICD-9 codes (International Classification of Diseases) in the databases

Exclusion Criteria:

* Non-adenotonsillectomy patients

Primary outcomes:
measure: Gather data from PHIS and contrast local databases (PFK versus Nationwide Children's)
timeFrame: after patient's discharge, an expected average between 6 months to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nationwide Children's Hospital
name: Vidya Raman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05801822: Screening of Subclinical Hypothyroidism in Pregnant Women
Official title: Prevalence of Sub-clinical Hypothyroidism Among Pregnant Women During First Trimester: Cross Sectional Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subclinical Hypothyroidism
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This is a cross-sectional study will be carried out on women attending Obstetrics Outpatient Clinic in Sohag University Hospitals for the booking antenatal care visit.

Brief summary: this study may help the physicians to evaluate the practice of universal screening of sub-clinical hypothyroidism and thyroid-stimulating hormone level. Detection of sub-clinical hypothyroidism early in pregnancy through thyroid-stimulating hormone sampling in the first trimester will allow achieving proper management and better maternal and neonatal outcome of these patients.

Detailed description: This is a cross-sectional study will be carried out on women attending Obstetrics Outpatient Clinic in Sohag University Hospitals between April and 1st December 2023 for the booking antenatal care visit and to be invited to enroll in the study. The attending physician will explain the nature of the study to the cases, the blood samples will be collected and to be assessed for the routine antenatal screening complete blood count, random blood sugar, hepatitis B virus and HIV, the same blood sample will be used to asses TSH level.

Eligibility criteria: Inclusion Criteria:

* Age group 18 years to 45 years.
* first trimester pregnant women.

Exclusion Criteria:

* Women with known thyroid disorders or previous thyroidectomy.
* Pregnant women with hyperemesis gravidarum.
* Molar pregnancy.

Primary outcomes:
measure: diagnosis of subclinical hypothyroidism early in pregnancy
timeFrame: in the first trimester of pregnancy ( first 12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: Amira M Mahmoud, bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01803022: Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer
Official title: Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Venous Thromboembolism
Cancer
Low Molecular Weight Heparin
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2013-03-04
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men or women aged 18 years or more with on-going cancer and recent diagnosis of Venous Thromboembolism, treated with Low Molecular Weight Heparin before entry into the study

Brief summary: The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.


Eligibility criteria: Inclusion Criteria:

* Subjects must provide informed consent
* Men or women aged 18 years or more
* Ongoing cancer disease recent diagnosis of veinous thromboembolism treatment with Low Molecular Weight Heparin before entry into the study

Exclusion Criteria:

- Contraindication to the use of Low Molecular Weight Heparin

Primary outcomes:
measure: Prescription conditions and use of Low Molecular Weight Heparin in the French usual practice for the treatment of symptomatic Venous Thromboembolism in patients with cancer at up to 6 months
timeFrame: up to 6 months
Secondary outcomes:
measure: To evaluate the consistency of the Low Molecular Weight Heparin use with French national recommendations on the treatment of Venous Thromboembolism in patients with cancer.
timeFrame: up to 6 months
measure: To evaluate Venous Thromboembolism recurrences, bleeding, thrombocytopenia and deaths during Low Molecular Weight Heparin treatment
timeFrame: up to 6 months
measure: To describe clinical factors associated with treatment duration with Low Molecular Weight Heparin and those associated with the occurrence of Venous Thromboembolism in patients with cancer
timeFrame: up to 6 months
measure: To evaluate the anticoagulant treatment perception and satisfaction by patients with cancer disease with a validated questionnaire
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Saint Louis
Study officials:
affiliation: Groupe Francophone Thrombose et Cancer
name: Dominique Farge Bancel, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06570122: Mobile Phone-Based Smoking-Cessation Intervention for Smoking Parents
Official title: Effectiveness of AI-powered Mobile Phone-based Interventions in Parental Smoking Cessation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 300
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: This study aims to explore the feasibility and preliminary effectiveness of a mobile phone-based intervention tailored specifically for smoking parents.

Detailed description: Parental smoking is associated with numerous adverse outcomes, including exposure to secondhand smoke, heightened risk of respiratory illnesses in children, and an increased likelihood that children will adopt smoking behaviors themselves. Despite awareness of these risks, many parents find it challenging to quit smoking due to stress, lack of support, and time constraints.

This randomized controlled trial (RCT) investigates the effectiveness of a mobile phone-based intervention tailored specifically for smoking parents. The intervention group will receive AI-powered chatbot cessation support, while the control group will be provided with brief cessation advice. The study aims to determine whether the AI-driven intervention is more effective in helping parents quit smoking compared to traditional brief advice.

Eligibility criteria: Inclusion Criteria:

1. aged 18 and above, reside in Zhuhai for the next 6 months
2. smoke at least 1 cigarette or use e-cigarettes daily
3. have a smartphone and a WeChat account, able to use WeChat skillfully

Exclusion Criteria:

1. Smokers who have communication barrier (either physically or cognitively)
2. Smokers who are currently participating in other SC programmes or services

Primary outcomes:
measure: Self-reported 7-day point prevalence quit rate
timeFrame: 3 and 6 months follow-up
measure: Eligibility rate
timeFrame: baseline
Secondary outcomes:
measure: Consent rate
timeFrame: baseline
measure: Percentage of Participant Engagement with E-Messages and Counselor Chats
timeFrame: 3 months follow-up
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Beijing Normal University
state: Guangdong
Study officials:
References:
Clinical trial NCT00367822: Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
Official title: Transdermal Lisuride: a Double-blind, Randomized, Active- and Placebo-controlled Multi-centre Phase III Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Keywords: Restless Legs Syndrome
dopamine agonist
lisuride
ropinirole
Lead sponsor: Axxonis Pharma AG
Sponsor class: INDUSTRY
First posted: 2006-08-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to compare an individually optimized dose of the lisuride TTS patch against placebo and against an individually optimized dose of oral ropinirole (active- and placebo-controlled design) in idiopathic and uremic RLS patients with regard to efficacy, safety, and quality of life.

Detailed description: Approximately 300 patients will be randomized to receive either lisuride, ropinirole or placebo in a 2:1:1 fashion. After completion of 12 weeks of double-blind treatment, eligible patients will have the option to continue treatment with the lisuride patch for further 36 weeks in an open-label extension of the study.

Primary outcome: Changes in the total score of the International Restless Legs Severity Scale (IRLS) from baseline to end of double-blind treatment (12 weeks) will be used as primary efficacy outcome measure.

Secondary objectives are to evaluate quality of life, safety and tolerability. After the double-blind period, long-term efficacy of lisuride will be assessed for further 36 weeks in an open-label extension of the study.

Eligibility criteria: Inclusion Criteria:

* Idiopathic or uremic RLS
* RLS Diagnostic Index (RLS-DI) \> 10
* Total score in the IRLS Rating Scale ≥ 15 at baseline
* No previous treatment for RLS or insufficient current therapy

Exclusion Criteria:

* Secondary RLS, e.g. due to iron deficiency (exception: uremia)
* History or presence of sleep disorders other than RLS

Primary outcomes:
measure: International Restless Legs Severity Scale (IRLS)
Secondary outcomes:
measure: RLS-6 scales
measure: CGI
Other outcomes:
Locations:
city: Nuremberg
country: Germany
facility: IMEREM GmbH
Study officials:
affiliation: Somnibene GmbH
name: Heike Benes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00348322: Safety/Efficacy of Systane Free vs Refresh Tears
Official title: An Evaluation of the Safety and Efficacy of Systane Free FID 105783 - II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 100
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 objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 in comparison to Refresh Tears Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.


Eligibility criteria: Inclusion Criteria:

* \> = 3 stain using NEI grid and need artificial tears at least some of the time.

Primary outcomes:
measure: Corneal Staining change from baseline
Secondary outcomes:
measure: Comfort, Conjunctival Staining
Other outcomes:
Locations:
city: El Paso
country: United States
facility: El Paso Facility
state: Texas
Study officials:
affiliation: Alcon Research
name: Mike Christensen
role: STUDY_DIRECTOR
References:
Clinical trial NCT01259622: Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation
Official title: A mulTi-center, Randomized, doUble-bliNded, Placebo-controlled Dose-escalating Study of the Effects of K201 on the RestorAtion of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation of Recent Onset
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: Sequel Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2010-12-14
Enrollment: 80
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 purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.


Eligibility criteria: Inclusion Criteria:

* Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
* Atrial fibrillation documented by ECG at the start of study drug infusion.

Exclusion Criteria:

* Previous exposure to K201
* QTcF (Fridericia correction) \>440 ms
* QRS interval \> 140 ms
* Paced atrial or paced ventricular rhythm on ECG
* History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
* History of amiodarone (oral or IV) in the last 3 months.
* Clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
* History of failed electrical cardioversion at any time in the past
* History of polymorphic ventricular tachycardia (e.g. torsades des pointes)
* History or family history of Long QT Syndrome
* History of ventricular tachycardia requiring drug or device therapy
* Ejection fraction of 40% or less.

Primary outcomes:
measure: proportion of subjects who convert to sinus rhythm
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
city: Glostrup
country: Denmark
city: Haderslev
country: Denmark
city: Hellerup
country: Denmark
city: Herlev
country: Denmark
city: Hvidovre
country: Denmark
city: Kolding
country: Denmark
city: København
country: Denmark
city: Odense
country: Denmark
city: Roskilde
country: Denmark
city: Silkeborg
country: Denmark
city: Svendborg
country: Denmark
city: Varde
country: Denmark
city: Viborg
country: Denmark
city: Ashkelon
country: Israel
city: Rehovot
country: Israel
city: Safed
country: Israel
Study officials:
affiliation: Sequel Pharmaceuticals
name: Paul Chamberlin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01795222: Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment
Official title: A Randomised Controlled Trial of Pediatric Sedation for Dental Treatment Using Oral Midazolam or Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Early Childhood Caries
Keywords: conscious sedation
stress psychological
dental care for children
child behavior
saliva
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
Collaborators: name: Federal University of Minas Gerais
First posted: 2013-02-20
Enrollment: 18
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment

Detailed description: This study was initially planned to investigate three paediatric sedation regimens that also included the following arms:

* oral midazolam + oral ketamine + inhaled sevoflurane
* oral midazolam + oral ketamine + inhaled oxygen So, the former protocol found in the PRS registry was called PedSed-III and included the aforementioned arms.

However, there was a long delay in fund release from the funding agency (State of Goias Research Foundation - FAPEG). Although the grant was approved in the beginning of 2013, resources were released in November 2013.

We could not wait for funding release because this study was part of the MS dissertation of the principal investigator that was supposed to be concluded in the first semester of 2013. Then we decided to develop a less robust study, including only two arms: oral midazolam versus oral placebo. The other variables of the study did not change. We finished this two-arms study and have the final results for that comparison.

Eligibility criteria: Inclusion Criteria:

* Children aged 2 to 5 years old, American Society of Anesthesiologists (ASA) I or II, healthy, with no cognitive impairment, presenting with early childhood caries

Exclusion Criteria:

* Children presenting with at least one of the following:
* airway obstruction and/or oral breathing;
* recent use of systemic corticosteroids
* needing less than two dental restorations;
* previous dental sedation.

Primary outcomes:
measure: child stress
timeFrame: At child's awaking and arrival in the dental office, 25 min after local anesthetic administration, 25 min after dental session completion
Secondary outcomes:
measure: Child behaviour
timeFrame: every minute during the dental treatment up to the end of the dental session, which is estimated in 60 minutes
measure: sedative safety
timeFrame: during and twenty four hours after the procedure
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Faculty of Dentistry, Federal University of Goias
state: Goias
Study officials:
affiliation: Universidade Federal de Goias
name: Heloisa S Gomes, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Goias
name: Aline C Batista, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03567122: Attentional Focus Influence During Cranio-Cervical Flexion Test
Official title: Attentional Focus Influence During Cranio-Cervical Flexion Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck; Anomaly
Muscle Weakness
Muscle Weakness Condition
Keywords: Cranio-cervical
Motor Control
Deep Flexor muscles
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to termine if a different attentional focus would alter the motor control in cervical muscles during the cranio-cervical test.

Detailed description: Asymptomatic subjects will be recruited to this study. Superficial electromyography of the Sternocleidomastoid, Range of Motion (ROM) and Cranio-Cervical Flexion Test (CCFT) will be measured before, immediately after change in focus of attention, 2 days after training under a particular focus of attention, and 7 days after training the task under the same focus of attention.

Subjects will be randomized into three groups: Internal focus of attention, external focus of attention and control group.

Eligibility criteria: Inclusion Criteria:

* Asymptomatic subjects

Exclusion Criteria:

* Cervical pain
* Historic of trauma/surgery to the cervical or thoracic spine or upper limbs
* Temporomandibular pain
* Neurological or systemic disorder

Primary outcomes:
measure: Change from baseline in Electromyographic Activity of Sternocleidomastoid
timeFrame: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
Secondary outcomes:
measure: Cranio-cervical Range of Motion
timeFrame: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
measure: Cranio-Cervical Flexion Test Performance
timeFrame: Baseline, Immediately after baseline, Post-Training (2 days after the baseline), Retention (7 days after finished training)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciências da Saúde
state: RS
Study officials:
affiliation: Professor, Researcher
name: Marcelo Faria, PhD, PT
role: STUDY_DIRECTOR
References:
Clinical trial NCT06184230: Persistence of Hepatitis A Antibody in Healthy Adults ~32 Years Post Vaccination.
Official title: Open Label Study to Assess the ~32-Year Persistence of Hepatitis A Antibody Among Participants in the Pivotal, Double-Blind, Placebo-Controlled Efficacy Study of VAQTA (Study 023-001)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hepatitis A
Lead sponsor: Best Healthcare Inc.
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to evaluate the persistence of Hepatitis A antibody \~32 years post vaccination in healthy adults. The questions this study will answer are: 1) how long antibody persists and 2) The immune response to an additional dose of vaccine among those with no detectable antibody. Participants will be asked to provide a blood specimen.

Those with no detectable antibody will be offered an additional dose of vaccine.

The kinetics of antibody response in this population will be summarized.


Eligibility criteria: Inclusion Criteria:

* Consent obtained
* Participated in original hepatitis A study in 1991
* No detectable hepatitis A antibody \~32 years after study start

Exclusion Criteria:

* Receipt of any dose of hepatitis A vaccine other than the hepatitis A vaccine used in the initial studies
* History of hepatitis A
* Receipt of blood transfusion or blood products, including immunoglobulins, within the past 6 months.
* Receipt of any vaccine within the 14 days before receipt of the additional dose of hepatitis A vaccine or scheduled to receive any vaccine within 30 days after receipt of a booster dose of vaccine.

Primary outcomes:
measure: Persistence of Antibody
timeFrame: 32 Years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: