louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05115604: Insomnia in the Patient With Schizophrenic Disorder: Evaluation of a CBT and Psychoeducational Intervention
Official title: Insomnia in the Patient With Schizophrenic Disorder: Evaluation of a Cognitive Behavioural and Psychoeducational Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Schizophrenia
Lead sponsor: Nou Barris Mental Health Center
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 40
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 study aims to evaluate the efficacy of a cognitive behavioural and psychoeducational intervention in patients with insomnia and diagnosed with a schizophrenic disorder.

Detailed description: Patients will be recruited by consecutive non-probabilistic sampling at the Outpatient Mental Health Centre of Nou Barris in Barcelona and subsequently randomised into 2 groups, control and intervention. Presence and severity of insomnia will be assessed through the following measurement instruments: ISI for presence and severity, PSQI for sleep quality and EQ-5D for health-related quality of life. Patients in intervention will attend 6 group sessions with cognitive behavioural and psychoeducational intervention and the control group will carry out the usual follow-up. Pre-post, 6-month and 9-month assessments will be analysed.

Eligibility criteria: Inclusion Criteria:

* Insomnia disorder (ISI scale)
* Schizophrenic disorder

Exclusion Criteria:

* Presence of severe psychopathological alteration
* Inability to understand the Spanish language or difficulties writing or reading

Primary outcomes:
measure: Change in the severity of insomnia, mesured with the Spanish version of the Insomnia Severity Insomnia
timeFrame: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
measure: Change in the quality of sleep, mesured with the Spanish version of The Pittsburgh Sleep Quality Index
timeFrame: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
Secondary outcomes:
measure: Change in health-related quality of life , mesured with the Spanish version of EuroQol-5D Scale
timeFrame: Changes in baseline scores at 6 weeks (end of six sessions CBT - Intervention group), at 6 months (Intervention gruop & control group) and at 9 months (Intervention gruop & control group)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Nou Barris Mental Health Center
state: Catalonia
Study officials:
affiliation: Nou Barris Mental Health
name: David Batalla-Martin, RN, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00175604: Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis
Official title: Comparative Trial of Botox Versus Conventional Treatment Used in the Management of Children With Congenital Muscular Torticollis (CMT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Torticollis
Keywords: Botox
torticollis
Congenital Muscular Torticollis (CMT)
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose is to investigate the effect of Botox on the treatment of congenital muscular torticollis (CMT). The investigators' hypothesis is that a Botox injection will be an effective treatment when used in conjunction with current treatment procedures.

Detailed description: The babies that require a neck collar for CMT will be randomly placed into two groups. One group will receive standard treatment which includes physiotherapy and occupational therapy. The other group will receive standard treatment plus an injection of Botox. The babies will be monitored to determine if one group has a more favorable outcome than the other in terms of range of motion, length of treatment time and number of required surgeries.

Eligibility criteria: Inclusion Criteria:

* Infants diagnosed with CMT and referred by family physician, pediatrician or orthopaedic surgeon
* Initial assessment and initiation of treatment prior to 4 months of age
* Cervical spine radiograph, no focal bony abnormality
* Head tilt greater than 5 degrees at 5 months of age
* Lateral head righting past neutral in upright suspension
* Restricted neck range of movement in lateral flexion or rotation or both
* Signed consent form and willingness to participate in the study
* Compliance with attending bi-weekly follow-up appointments

Exclusion Criteria:

* Any other diagnosis affecting tone or muscle function
* Any condition that would preclude an anesthetic
* Any vertebral abnormalities identified by radiograph
* Attending other health practitioners for treatment, i.e., massage therapist, chiropractor
* Any associated ocular problems as determined by a pediatric ophthalmologist

Primary outcomes:
measure: The primary outcome will be range of motion.
timeFrame: assessed bi-weekly until treatment is complete
Secondary outcomes:
measure: The secondary outcomes will be length of treatment time and number of required surgeries.
timeFrame: assessed bi-weekly until treatment is complete
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital, Dept. of Orthopedics
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Stephen Tredwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06848504: MedSMA℞T Mobile ED
Official title: Implementing MedSMA℞T Families in the Emergency Department Setting: A Game-based Approach for Improving Opioid Safety Among Adolescents and Parents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opiate-Related Disorders
Opiate Use Disorder
Opioid
Keywords: Opioid Education
Opioid Use Disorder
Opiate-Related Disorders
Opiate
Opioid
Serious Game
Smartphone
Smartphone Game
Medication safety
Adolescent Health
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 244
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn if a new smartphone-based intervention can help with factors related to opioid misuse in parents and adolescent/early adult children. The main question it aims to answer is:

• Can this intervention improve knowledge of, and attitudes towards, opioid misuse over traditional opioid-related counseling alone?

Participants will, in addition to receiving opioid counseling:

* Join an online meeting with research staff to test the smartphone-based intervention
* Report demographic information
* Complete surveys about opioids
* Complete a family medication safety plan
* Complete surveys after 3, 6, and 9 months


Eligibility criteria: Inclusion Criteria:

* Adults who receive an opioid prescription from a study Emergency Department, AND
* who report having an adolescent, aged 12-18, living at home, AND
* who speak and understand English
* Each participant must have the ability to provide informed consent

Exclusion Criteria:

* Adults who do not receive an opioid prescription from a study Emergency Department AND/OR
* who do not have an adolescent, aged 12-18, living at home, AND/OR
* who do not speak or understand English
* Adults and/or adolescents who do not have the ability to provide informed consent

Primary outcomes:
measure: Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study
timeFrame: Baseline, 3, 6, and 9 months.
Secondary outcomes:
measure: Change in Safe Opioid Storage Behaviour over 9 months
timeFrame: Baseline, 3, 6, and 9 months.
measure: Change in Opioid Disposal Behaviour over 9 months
timeFrame: Baseline, 3, 6, and 9 months.
measure: Change in Medication Understanding and Use Self-Efficacy (MUSE) scale scores over 9 months
timeFrame: Baseline, 3, 6, and 9 months.
measure: Change in Family Communication Behaviour Patterns over 9 months
timeFrame: Baseline, 3, 6, and 9 months.
Other outcomes:
Locations:
city: Rockford
country: United States
facility: Swedish American Hospital
state: Illinois
city: Madison
country: United States
facility: East Madison Hospital
state: Wisconsin
city: Madison
country: United States
facility: University Hospital
state: Wisconsin
Study officials:
affiliation: University of Kentucky College of Pharmacy
name: Olufunmilola Abraham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00971204: Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Official title: Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paroxysmal Atrial Fibrillation
Keywords: atrial fibrillation
PAF
Lead sponsor: CardioFocus
Sponsor class: INDUSTRY
First posted: 2009-09-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* 18 to 70 years
* paroxysmal atrial fibrillation
* failure of at least one AAD
* others

Exclusion Criteria:

* overall good health as established by multiple criteria

Primary outcomes:
measure: Freedom From Recurrence of Atrial Fibrillation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Charlottesville
country: United States
facility: University Of Virginia Health System
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
affiliation: CardioFocus, Inc.
name: Burke Barret
role: STUDY_DIRECTOR
References:
Clinical trial NCT05387304: A Follow-up Study of Asymptomatic Infections and Diagnosed Patients With Covid-19 in Shanghai
Official title: A Follow-up Study of Asymptomatic Infections and Diagnosed Patients With Covid-19 in Shanghai
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 250000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: asymptomatic infections and diagnosed patients with COVID-19 in fangcang shelter hospitals in Shanghai

Brief summary: This study is to clarify the distribution characteristics, host and clinical characteristics, disease outcome and risk factors, changes of multiple organs such as cardiopulmonary function and changes in social and psychological indicators during long-term follow-up of omicron variant asymptomatic infections and diagnosed patients


Eligibility criteria: Inclusion Criteria:

* SARS-Cov-2-RNA positive
* informed consent signed

Exclusion Criteria:

* informed consent rejected

Primary outcomes:
measure: long-term outcomes，changes of clinical characteristic and social psychology
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
affiliation: Ruijin Hospital
name: Guang Ning, Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Erzhen Chen, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01900704: Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4
Official title: A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nocturia
Lead sponsor: Serenity Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-16
Enrollment: 810
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia


Eligibility criteria: Inclusion Criteria:

* Male and female 50 years or older
* Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night

Exclusion Criteria:

* CHF
* Diabetis Insipidus
* Renal insufficiency
* Hepatic insufficiency
* Incontinence
* Illnesses requiring systemic steroids
* Malignancy within the past 5 years
* Sleep apnea
* Nephrotic syndrome
* Unexplained pelvic mass
* Urinary bladder neurological dysfunction
* Urinary bladder surgery or radiotherapy
* Pregnant or breast feeding

Primary outcomes:
measure: Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment
timeFrame: 12 weeks
measure: Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Stephen M. Auerbach, MD
state: California
Study officials:
References:
Clinical trial NCT01882504: Proof of Concept Study of Gevokizumab in the Treatment of Pyoderma Gangrenosum
Official title: An Open-label, Proof of Concept Study of Gevokizumab in the Treatment of the Acute, Inflammatory Phase of Pyoderma Gangrenosum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pyoderma Gangrenosum
Keywords: Pyoderma Gangrenosum
Classic Pyoderma Gangrenosum
Atypical Pyoderma Gangrenosum
Peristomal Pyoderma Gangrenosum
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2013-06-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.


Eligibility criteria: Inclusion Criteria:

* An established diagnosis of pyoderma gangrenosum
* Currently experiencing an inflammatory episode of pyoderma gangrenosum
* Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

* Clinical evidence of acutely infected pyoderma gangrenosum
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent or chronic systemic infections
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Improvement in the Investigator's Assessment of the pyoderma gangrenosum target ulcer
timeFrame: Day 1 through Day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Miami Shores
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Verona
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Knoxville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT01957904: ArterX Safety and Efficacy Study for Cardiac Indications
Official title: Prospective, Multi-Center, Open-Label, Post-Market ArterX® Safety and Efficacy Study Protocol for Cardiac Indications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Disease
Keywords: ArterX, surgical sealant
Lead sponsor: Tenaxis Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to confirm the acute safety and performance of the ArterX® Surgical Sealant as a hemostatic agent. The study will collect data in support of publications and future product labeling revisions, to provide additional clinical information on use and further details regarding product safety.


Eligibility criteria: Inclusion Criteria:

\>18 years of age, Male or female If female, subject is post-menopausal, has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure and is practicing abstinence or a highly effective method of contraception for the duration of the study.

The subject or guardian must provide written Informed Consent using a form that is reviewed and approved by the Ethics Committee.

The subject is willing and able to be contacted for 3 months follow-up and attend follow-up visits as needed per protocol.

The subject is determined by the surgeon to be at risk for poor hemostasis.

Exclusion Criteria:

Subject undergoing emergency surgery. Subject undergoing minimally invasive surgery. Subject has clinically significant medical, psychiatric, or cognitive illness or drug/alcohol abuse that in the opinion of the investigator would affect the subject's safety or compliance with study assessments or follow-up.

Subject has immune system disorders/immunodeficiency or immunosuppression. Subject has participated in another clinical study within 30 days prior to surgery or has received an investigational drug or device within the past 30 days.

Subject is pregnant, may become pregnant or is currently breast feeding

-

Primary outcomes:
measure: Number of subjects with immediate sealing of suture/staple line
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Trier
country: Germany
facility: Krankenhaus Der Barmherzigen Bruder
Study officials:
References:
citation: Skorpil J, Paraforos A, Mandak J, Cohn WE, Hajek T, Friedrich I. Effective and rapid sealing of coronary, aortic and atrial suture lines dagger. Interact Cardiovasc Thorac Surg. 2015 Jun;20(6):720-4; discussion 724. doi: 10.1093/icvts/ivv061. Epub 2015 Mar 24.
Clinical trial NCT06189404: Effect of Tigulixostat on the Pharmacokinetics of Theophylline
Official title: A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Oral Doses of Tigulixostat on the Pharmacokinetics of a Single Oral Dose of Theophylline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Hyperuricemia
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2024-01-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A phase 1, open-label, drug-drug interaction study to evaluate the effect of multiple doses of tigulixostat on the pharmacokinetics of single-dose theophylline in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Male or female, Ages 18 to 55, inclusive.
* BMI 18.0 - 32.0 kg/m2, inclusive, at screening.
* In good general health as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
* Females of childbearing potential and males who agree to use contraception. Non-pregnant, non-lactating females who must have a negative pregnancy test at screening and check-in.

Exclusion Criteria:

* Significant history or indications of ill-health, as judged by the investigator.
* Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion.
* eGFRcr of \<60 (mL/min)/1.73 m2 at screening.
* alanine aminotransferase, aspartate aminotransferase, or total bilirubin ≥2 times the upper limit of normal at screening and check-in.
* Used any prescription or over-the-counter medications (except acetaminophen \[Tylenol\] up to 2 g per day), including herbal or nutritional supplements, within 14 days before the first dose of study drug.
* Consumed grapefruit or grapefruit juice, Seville orange or Seville orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products within 48 hours before the first dose of study drug.
* History of hypersensitivity to theophylline or other xanthines and tigulixostat.

Primary outcomes:
measure: AUC0-t of theophylline with and without tigulixostat
timeFrame: Up to 72 hours
measure: AUC0-inf of theophylline with and without tigulixostat
timeFrame: Up to 72 hours
measure: Cmax of theophylline with and without tigulixostat
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Incidence of reported adverse events (AEs)
timeFrame: Up to Day 28
measure: AUC0-t of tigulixostat and metabolite GD-MET-1
timeFrame: Up to 24 hours
measure: Cmax of tigulixostat and metabolite GD-MET-1
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD - Austin Research Unit
state: Texas
Study officials:
References: