louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00078793: Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis
Official title: Phase IV Registry of Etanercept (Enbrel®) In Children With Juvenile Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Rheumatoid Arthritis
Keywords: JRA
Registry
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Immunex Corporation
First posted: 2004-03-09
Enrollment: 600
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric subjects age 2 to \< or = 18 years of age with polyarticular course or systemic JRA who have recently started and are currently receiving: etanercept alone or in combination with methotrexate or other DMARDs; methotrexate alone or in combination with other DMARDs.The population includes pediatric subjects who completed Immunex protocol 016.0028 and selected other Immunex protocols will be eligible for this study once they change to marketed etanercept.

Brief summary: This study will evaluate long-term safety of etanercept with or without other DMARDs in children with polyarticular course or systemic juvenile rheumatoid arthritis (JRA) compared to a cohort of subjects with polyarticular or systemic JRA receiving methotrexate with or without other DMARDs.


Eligibility criteria: * JRA by American College of Rheumatology (ACR) criteria - Active joints - Initiate etanercept alone, etanercept plus methotrexate or other DMARDs, methotrexate alone, or methotrexate with other DMARDs within 6 months of entry into Registry
* Polyarticular or systemic RA in 3 or more joints at start of treatment

Primary outcomes:
measure: Adverse event rates and severity
timeFrame: 36 months of observation
Secondary outcomes:
measure: Growth data and Tanner scores
timeFrame: 36 months of observation
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Giannini EH, Ilowite NT, Lovell DJ, Wallace CA, Rabinovich CE, Reiff A, Higgins G, Gottlieb B, Chon Y, Zhang N, Baumgartner SW. Effects of long-term etanercept treatment on growth in children with selected categories of juvenile idiopathic arthritis. Arthritis Rheum. 2010 Nov;62(11):3259-64. doi: 10.1002/art.27682.
citation: Giannini EH, Ilowite NT, Lovell DJ, Wallace CA, Rabinovich CE, Reiff A, Higgins G, Gottlieb B, Singer NG, Chon Y, Lin SL, Baumgartner SW; Pediatric Rheumatology Collaborative Study Group. Long-term safety and effectiveness of etanercept in children with selected categories of juvenile idiopathic arthritis. Arthritis Rheum. 2009 Sep;60(9):2794-804. doi: 10.1002/art.24777.
Clinical trial NCT06470893: Online Exposure Therapy for Obsessive-Compulsive Disorder (OCD) Study
Official title: Online Exposure Therapy for Obsessive-Compulsive Disorder (OCD) Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The overarching goal of this protocol is to investigate mechanisms that influence symptom outcomes of exposure and response prevention (ERP) therapy for OCD. Mechanisms may include affective processes, learning factors, cognitive factors, or other constructs that could influence treatment outcomes. The study team will conduct this research within the context of an effective online treatment for OCD called OCD-NET. OCD-NET is bibliotherapy with coaching and its content is reflective of standard care for OCD.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* Located within the United States
* 18-90 years old
* Able to provide consent
* Current diagnosis of OCD as assessed by clinical interview

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Participants currently located outside of the United States
* Prisoners
* Participants with hoarding as the primary OCD symptom
* Severe mental illness (e.g. schizophrenia, substance abuse); organic brain syndrome; or serious, current suicidal/homicidal ideation (based on phone screening or initial assessment)
* Concurrent enrollment in another psychotherapy treatment
* Participants taking psychotropic medication may be excluded if:

  * They have started a brand new psychotropic medication within the last 12 weeks
  * They have changed the dose of their psychotropic medication within the last 4 weeks
  * They anticipate that they cannot maintain the current dose of their psychotropic medication for the duration of the study
* Participants may be excluded if they have any cognitive or physical impairments that would interfere with their participation (e.g., significant head injury, cognitive disability, dementia).

Primary outcomes:
measure: Change in OCD Symptoms Measured by Yale-Brown Obsessive Compulsive Scale-Second Edition (YBOCS-II)
timeFrame: Baseline, up to 12 months (end of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Kiara Timpano, PhD
role: STUDY_CHAIR
affiliation: University of Miami
name: Amelia Dev, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01850693: Assessment of Coronary Artery Disease in Stroke Patients
Official title: Prevalence and Characteristics of Coronary Atherosclerosis in Stroke Patients Using Coronary CT Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
stroke
coronary CT angiography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2013-05-09
Enrollment: 1657
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients on the basis of TOAST classification

Brief summary: This study is to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of coronary atherosclerosis in stroke patients with coronary CT angiography.

Detailed description: Stroke and coronary artery disease (CAD) share common risk factors and pathological mechanisms. CAD is an important cause of death in patients with stroke.

Currently, coronary CT angiography (CCTA) is very useful non-invasive tool for detection of CAD and plaque analysis.

Therefore, the investigators aimed to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of CAD in stroke patients through follow-up (more than 5 years) using CCTA.

Eligibility criteria: Inclusion Criteria:

* Acute stroke patients who diagnosed by clinical and brain MR imaging
* Who performed coronary CT angiography within 3 months after acute stroke

Exclusion Criteria:

* intracranial hemorrhage including intracerebral, subdural or subarachnoid hemorrhage
* brain tumor
* Previous myocardial infarction
* Previously performed percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or other cardiac surgery
* Insufficient medical record
* Poor image quality of CCTA scan

Primary outcomes:
measure: MACE (Major Adverse Cardiac Event)
timeFrame: Participants will be followed until June. 2015, an expeded average of 5 years
Secondary outcomes:
measure: Any cardiac events
timeFrame: Participants will be followed until June. 2015, an expeded average of 5 years
Other outcomes:
measure: Repeated stroke
timeFrame: Participants will be followed until June. 2015, an expeded average of 5 years
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Department of Radiology, Seoul National University Bundang Hospital
name: Eun Ju Chun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02368093: Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis
Official title: A Double-blind, Placebo-controlled, Therapeutic Trial With Antitussive Drug-Dextromethorphan: Aimed to Determine Its Therapeutic Effect in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
Collaborators: name: TSH Biopharm Corporation Limited
First posted: 2015-02-20
Enrollment: 48
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: Rheumatoid arthritis were randomized to a 6-month treatment of oral dextromethorphan hydrobromide or placebo as an add-on therapy to traditional disease-modifying anti-rheumatic drugs (DMARDs). Disease activity were assessed.

Detailed description: Biologic-naïve rheumatoid arthritis (RA) patients who fulfilled the 2010 criteria of the American College of Rheumatology (ACR) for RA were enrolled. All patient were randomized to a 6-month treatment with either oral DXM \[dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan) with T1/2 = 7.75h, Tmax = 4.83h, Cmax = 14.6 ng mL-1 and mean residual time = 5.86 h, 120mg per day with once daily dose taken after breakfast\] or placebo pills with the same appearance as DXM tablets. The randomization was performed by the pharmacy of the Taichung Veterans General Hospital. Non-study medications were not changed during the course of study.

Twenty-four patients received add-one DXM therapy and the other 24 patients received traditional DMARDs alone in stable dose. Disease activity was assessed by the 28-joint disease activity score (DAS28) before starting add-on DXM therapy (as a baseline) and at the end of 6 months of therapy with or without add-on DXM. Patients were categorized as good, moderate or poor responders based on the amount of change in the DAS28 and the level of DAS28 reached. Good responders were defined as patients who had a decrease in DAS28 from baseline (∆DAS28)\>1.2 and a DAS28≦3.2 at evaluation time; moderate responders had either ∆DAS28\>1.2 and a DAS28\>3.2 or ∆DAS28 of 0.6-1.2 and a DAS28≦5.1 at evaluation time; and poor responders were those who had either ∆DAS28\<0.6 or a DAS28\>5.1 at evaluation time.

Eligibility criteria: Inclusion Criteria:

* Patients fulfilling the 2010 criteria of the American College of Rheumatology (ACR) for RA

Exclusion Criteria:

* Receive biological therapy for RA, including Etanercept, Adalimumab, Golimumab, Tocilizumab, Rituximab, Abatacept.

Primary outcomes:
measure: Good European League Against Rheumatism (EULAR) Therapeutic Response Rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Division of Allergy,Immunology and Rheumatology, Taichung Veterans General Hospital
name: Der-Yuan Chen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04793893: Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation With ReLEX Smile Surgery
Official title: Treatment of Residual Hypermetropic Refraction on Young Patients After LASIK Using Human Fresh Corneal Lenticule Implantation Using Relex Smile Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Refractive Errors
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: LASIK (laser-assisted in situ keratomileusis) is a type of refractive surgery for correction of myopia, hyperopia and astigmatism. Yet approximately 30% of operated patients have symptoms like glare, halos, dry eyes and especially residual hypermetrop refractive errors.

Residual hypermetrop refractive errors are difficult to treat surgically, the current treatment is Refractive Lens Implantation - risks are similar to those of cataract surgery (endophthalmitis, loss of accommodation, etc.)

Detailed description: The main problem at young patients post - LASIK after one year is residual refractive errors.

The method used in Eye Hospital is treatment with implantation of human fresh corneal lenticule (min. -1.50D) taken from myopic patients in post - LASIK patients with residual refractive error (min. +1.0D).

1. The flap of LASIK is lifted, cleaned and then the lenticule is gently inserted. The fresh myopic lenticule is implanted under the guidance of corneal topography in young patients with hypermetropic astigmatism residual refraction, according to the low K value. In cases where astigmatism is not present the lenticule is positioned in central position under the flap.
2. The flap of LASIK is not touched or lifted but using VisuMax femtosecond laser we created the stromal pocket with diameter 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness set to 140 μm from corneal surface and 4 mm superior incision. Hinge position flap was set at 90° angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision.

Eligibility criteria: Inclusion Criteria:

* residual hypermetropic refraction,
* low visual acuity

Exclusion Criteria:

* active anterior segment pathology,
* glaucoma,
* retinae detachment,

Primary outcomes:
measure: Increase of visual acuity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pristina
country: Kosovo
facility: Eye Hospital Pristina
Study officials:
References:
Clinical trial NCT06793293: Postoperative in Cesarean Section, the Women Suffering from Pain Due to Wound "incisional Pain", High Level Laser One of Most Effective Methods That Promoting Healing and Decrease Pain so It Will Effective If Use in Decreasing Pain of Cesarian Section
Official title: Effect of High Level Laser Therapy on Postoperative Cesarean Section Incisional Pain
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cesarean Section Pain
Keywords: cesarean section pain
High power laser
decreasing pain
Postoperative pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: High power level laser used after cesarian section to decrease pain for 3 sessions first, second and third day.
Primary purpose: TREATMENT

Brief summary: High power laser is safe and effective methods, it's uses increasing one day after day in decreasing pain and promoting healing so its use in postoperative cesarian section will help mothers to overcome pain and return to ADLs faster


Eligibility criteria: Inclusion Criteria:

* Their ages will be ranged from 20-40 years. 2. Their BMI will be less than 30 Kg\\m 2 3. Patients with lower segment cesarean section (Poursalehan et al., 2018 \&amp; de Holanda et al., 2020).

Exclusion Criteria:

* 1. Patients with upper segment cesarean section. 2. Diabetic patient. 3. Patient with malignancy, benign tumors with the possibility to become malignant. 4. Infection of the skin (Poursalehan et al., 2018).

Primary outcomes:
measure: Visual analog scale (VAS):
timeFrame: third day
measure: Blood test
timeFrame: third day
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT06485193: The Innate Immune Response and Enteric Nervous System in Crohn's Disease.
Official title: Det medfødte Immunforsvar og Det Enteriske Nervesystem Ved Crohns Sygdom
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Crohn Disease
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 12
Sex: ALL
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: Patients with Crohn's disease

Brief summary: The study aims to explore the relationships between inflammation, nerve changes, and the expression of interferon-stimulated proteins in inflamed and non-inflamed bowel areas from patients with Crohn's disease. Crohn's disease is a chronic inflammatory condition with complex causes and mechanisms that remain uncertain despite extensive research.

Methods and Procedures This exploratory study utilizes tissue samples from a clinical biobank at Aalborg University Hospital. The samples are paraffin-embedded blocks from which tissue sections are prepared for immunohistochemical and histological staining. The study focuses on assessing the expression of interferon-stimulated proteins through optimized immunohistochemical staining methods, ensuring reproducibility via automated machines. The protein expressions are then analyzed qualitatively and semi-quantitatively and compared with structural changes in the bowel tissues.


Eligibility criteria: Inclusion Criteria:

* Histological preparations (tissue samples) from patients with Crohn's disease who have undergone bowel resection at Aalborg University Hospital in the period from 2012 to 2023.

Exclusion Criteria:

* If the tissue material does not include the ileocecal region.
* If the pathology report does not indicate that there is tissue material from both inflamed and non-inflamed areas.
* If the patient has registered a prohibition against research in the Tissue Utilization Registry.
* The selection of cases starts with the most recent (by date) and stops when 25 suitable cases are found.

Primary outcomes:
measure: MxA expression
timeFrame: June 1 2024
Secondary outcomes:
measure: Enterovirus positivity
timeFrame: June 1 2024
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Northern Region
Study officials:
References:
Clinical trial NCT01939093: Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis
Official title: Therapeutic Effect Between Quetiapine and Haloperidol on the Treatment of Methamphetamine - Induced Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Methamphetamine-induced Psychosis
Keywords: Quetiapine
Haloperidol
Methamphetamine
Psychosis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Thanyarak Institute
name: National Research Council of Thailand
First posted: 2013-09-11
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 aims of this study are to compare the antipsychotic and adverse events of quetiapine, an atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic disorder, in individuals with MAP.

Detailed description: Eighty individuals with MAP will be randomly assigned into two treatment groups, i.e. treatment with quetiapine and haloperidol. The quetiapine group will receive quetiapine at least 100 mg per day and the haloperidol group will receive haloperidol at least 2 mg per day orally once a day for four weeks. The doses will be increased every 5 days until no psychotic symptom is observed from the Positive and Negative Syndrome Scale. Common antipsychotic adverse events will be checked and documented daily.

Eligibility criteria: Inclusion Criteria:

* Having a psychotic episode with current use of methamphetamine
* Positive urine toxicology test for methamphetamine on the first day of hospitalization

Exclusion Criteria:

* Using other illegal substances
* Having a history of primary psychotic disorders or using antipsychotic agents
* Having a chronic medical disease, e.g. essential hypertension, diabetes, epilepsy, stroke

Primary outcomes:
measure: Positive and Negative Syndrome Scale
timeFrame: Every day in Week 1.
measure: Positive and Negative Syndrome Scale
timeFrame: Every two days in Week 2 and 3.
Secondary outcomes:
measure: Antipsychotic Adverse Event Form
timeFrame: Every day for three weeks.
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Thanyarak Institute on Drug Abuse
Study officials:
affiliation: Thanyarak Institute on Drug Abuse
name: Viroj Verachai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00753493: Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients
Official title: Phase I Pharmacokinetic and Safety Study of Intravenous Topiramate in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Migraines
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2008-09-16
Enrollment: 20
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 aims of this study are to determine, in adult patients on maintenance topiramate therapy, the steady-state pharmacokinetics and safety of orally and intravenously administered topiramate.

Detailed description: The long-term goal of this research project is to develop a more effective, safer therapy for neonatal seizures. Prior to using an investigational intravenous topiramate formulation in children and neonates, the pharmacokinetics and safety of the formulation must be demonstrated in adults. The immediate aims of this study are to determine the pharmacokinetics and safety of a novel intravenous topiramate formulation. An additional aim is to determine if sex, advancing age, or genotype affects topiramate absorption, distribution, or elimination.

Eligibility criteria: Inclusion Criteria:

* Persons taking topiramate
* Persons 18 years of age and older

Exclusion Criteria:

* Patients who are pregnant
* Patients who are breast feeding
* Patients with significant medical problems who may not tolerate intravenous administration
* Patients taking medications known to affect topiramate disposition

Primary outcomes:
measure: Safety as measured by the occurrence of adverse events
timeFrame: 96 hours after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: James C Cloyd, PharmD
role: PRINCIPAL_INVESTIGATOR
References: