louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03576027: Hyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases
Official title: Evaluation of the Effectiveness of Hyperbaric Oxygen Therapy in the Treatment of Inflammatory Bowel Disease in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Children, Only
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Military Institute od Medicine National Research Institute
First posted: 2018-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study assesses the effectiveness of hyperbaric oxygen therapy in the treatment of inflammatory bowel disease in children.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Crohn's disease or ulcerative colitis according to the criteria from Porto - based on the clinical condition as well as imaging and endoscopic examinations with histopathological assessment;
* failure to achieve the remission despite the use of standard treatment in accordance with international guidelines;
* written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.

Exclusion Criteria:

* intolerance of enclosed spaces;
* contraindications for hyperbaric therapy: otolaryngological (otitis media, sinusitis); cardiac (clinically significant defects or arrhythmias); pneumological (clinically significant defects)
* exacerbation of inflammatory bowel disease during the therapy;
* contraindications for hyperbaric therapy in a patient's caregiver in a situation, where the patient requires his/hers presence inside the hyperbaric chamber during the session.

Primary outcomes:
measure: Change of the ulcerative colitis activity
timeFrame: 40 days
measure: Change of the Crohn's disease activity
timeFrame: 40 days
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 40 days
measure: Concentration of proinflammatory cytokines
timeFrame: 40 days
measure: Maintaining remission of the ulcerative colitis
timeFrame: 1 year
measure: Maintaining remission of the Crohn's disease
timeFrame: 1 year
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Lukasz Dembinski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01366027: PRISM Registry: Pseudobulbar Affect Registry Series
Official title: PRISM Registry: Pseudobulbar Affect Registry Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Amyotrophic Lateral Sclerosis (ALS)
Multiple Sclerosis (MS)
Parkinson's Disease
Stroke
Traumatic Brain Injury
Keywords: pseudobulbar affect
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 5290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: The population for this study will be 18 years and over

Brief summary: PBA is a neurologic condition that is estimated to impact over a million patients and their families in the United States. PBA occurs secondary to an otherwise unrelated neurologic disease or injury, and manifests as involuntary, frequent, and disruptive outbursts of crying and/or laughing. Progress has been made in better understanding this debilitating condition, but much more needs to be done. That's why a new PBA patient registry, PRISM (Pseudobulbar Affect RegIstry Series), has been initiated.

The goal of PRISM is to establish the prevalence and quality of life (QOL) impact of PBA in patients with underlying neurologic conditions including

* Alzheimer's disease
* Amyotrophic lateral sclerosis
* Multiple sclerosis
* Parkinson's disease
* Stroke
* Traumatic brain injury

Because this is an observational registry, it doesn't require you to intervene with any specific treatment or procedure. Your participation allows the PRISM registry to collect and analyze data from your site and also compare it to national numbers captured in the PRISM registry about PBA across all of the major at-risk neurologic populations.


Eligibility criteria: Inclusion Criteria:

* All participants must have underlying neurologic conditions known to be risk factors of PBA: Alzheimer's Disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Parkinson's Disease, Stroke, and Traumatic Brain Injury.
* The population for this study will be 18 years and over

Primary outcomes:
measure: Prevalence of PBA (using CNS-LS)
timeFrame: Upon Study Enrollment/Entry
Secondary outcomes:
Other outcomes:
Locations:
city: Aliso Viejo
country: United States
facility: Avanir Pharmaceuticals
state: California
Study officials:
affiliation: Avanir Pharmaceuticals
name: Randall Kaye, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05117827: Pediatric Powered Wheelchair Standing Devices: An Exploratory Study
Official title: Pediatric Powered Wheelchair Standing Devices: An Exploratory Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Spinal Muscular Atrophy
Spinal Cord Injuries
Spina Bifida
Development Delay
Genetic Disease
Lead sponsor: Grand Valley State University
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 4
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: For children who use a power wheelchair, a powered wheelchair standing device (PWSD) may be considered for daily use. A PWSD allows a child to electronically move between sitting and standing and can be driven in either position. Existing published PWSD research in pediatrics is limited to boys with Duchenne muscular dystrophy (DMD).(1, 2) While these studies provide some insights into PWSD use in boys with DMD, they do not reflect PWSD use in children with other conditions. The purpose of this exploratory study is to determine the feasibility of a research protocol exploring use of a PWSD in children who have neurodevelopmental conditions other than DMD.


Eligibility criteria: Inclusion Criteria:

1. Is 5-17 years of age. NOTE: Participants must be under 18 for the duration of the study.
2. Diagnosed with a neurodevelopmental condition resulting in an inability to functionally ambulate.
3. Can safely assume and maintain a supported standing position
4. Has sufficient upper extremity and function to safely use a PWSD
5. Can communicate pain or discomfort through verbalization, vocalization, use of augmented communication, etc.
6. Can safely use the PWSD in areas of their home
7. Has at least one parent/caregiver who is able to converse in English and actively participate in a device-use education provided in English
8. The PerMobil PWSD can be set up to meet the child's specific needs
9. Medical Clearance to trial the PWSD
10. Participants must reside in Michigan

Exclusion Criteria:

1. Has a diagnosis of Duchenne muscular dystrophy.
2. Any reason that it would not be safe for the child to use a PWSD

Primary outcomes:
measure: Participation in children
timeFrame: 2 years
Secondary outcomes:
measure: Parental/caregiver perceptions
timeFrame: 2 years
measure: Children's perceptions
timeFrame: 2 years
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Grand Valley State University
state: Michigan
Study officials:
References:
Clinical trial NCT04677127: Effect of HBM Based Education on Glycemic Control of Type 2 Diabates Patients
Official title: The Effect of Health Belief Model and Health Literacy Level Based Education and Counseling on Glycemic Control in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This pre-post-test randomized controlled (parallel group) experimental design study aimed to determine the effect of education based on health belief model and health literacy level of patients with type 2 diabetes on disease management. Study was carried out in Isparta Davraz Family Health Centre between June 17, 2019 and March 02, 2020. Sample consisted of 120 patients with type 2 diabetes, selected by simple randomization method, including 60 patients for the intervention group and 60 patients for the control group.

Patients in intervention and control were also sub-grouped according to their health literacy level. The intervention group was given training based on the health belief model with groups of 10-12-13 people every week for 6 weeks in the Family Health Center, followed by telephone counseling in the following 6 weeks and follow-up for 12 weeks. Patients in the control group were assessed at the first interview and the last interview, received routine health care, and no intervention was performed during the research. "Patient Data Form", "Health Literacy Scale Among Diabetes Patients", "Health Belief Model Scale in Diabetes Patients" and "Type 2 Diabetes Self-Efficacy Scale" used for data collection. Data were collected both on the first day of the study and in the 24th week.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 Diabates Mellitus at least for a year
* Literate

Exclusion Criteria:

* Problems with vision and hearing

Primary outcomes:
measure: Glycemic Control Change
timeFrame: pre-test (week 1), post-test (week 24)
Secondary outcomes:
measure: Health Belief Model Questionnaire
timeFrame: pre-test (week 1), post-test (week 24)
measure: Self-Efficacy Questionnaire
timeFrame: pre-test (week 1), post-test (week 24)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: İmatullah Akyar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agrali H, Akyar I. The effect of health literacy-based, health belief-constructed education on glycated hemoglobin (HbA1c) in people with type 2 diabetes: A randomized controlled study. Prim Care Diabetes. 2022 Feb;16(1):173-178. doi: 10.1016/j.pcd.2021.12.010. Epub 2021 Dec 31.
Clinical trial NCT00518427: Evaluate Quality of Life in Type 2 Diabetes, Before and After Change to Insuline Glargine
Official title: A Multicenter Clinical Trial to Evaluate Quality of Life in Patients With Type 2 Diabetes Before and After Changing Therapy to a Combination of Insulin Glargine and Oral Antidiabetic Drugs in a Real Life Situation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-08-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective:

To assess quality of Life (QoL) changes and treatment satisfaction in a real life situation in patients with Type 2 diabetes inadequately controlled on a combination of oral antidiabetic drugs (OAD) plus Neutral Protamine Hagedrone (NHP) insulin treatment that are switched to insulin glargine.

Secondary objective:

To determine:

change in HbA1c, comparision of the incidence of symptomatic hypoglycemia and severe hypoglycemia before and after introduction of insulin glargine, change in weight, change in insulin dose.


Eligibility criteria: lists of inclusion and exclusion criteria:

Inclusion Criteria:

* Patients with type 2diabetes inadequately controlled on a combination of OAD + NPH insulin for more than three months
* Stable OAD therapy for at least three months, according to the following specified daily dose: glibenclamide\> 3, 5 mg, glipizid \>5 mg, glimeperid \>2mg, metformin\>1000 mg, acarbose \>150 mg
* HbA1c \> 7,0%
* Ability to perform QoL assessment
* Body Mass Indes: women \<30 and men \<32

Exlusion criteria:

* Autoimmune diabetes, as defined by WHO
* Ongoing treatment with tiasolidindion drug
* Retinopathy with surgical treatment during preceding three months of study entry or requiring treatment within three months after study entry
* Drug abuse
* Hypersensitivity to insulin glagine excipients

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The fear of hypoglycaemia scale (HFS)
timeFrame: before the switch to insulin glargine and at 3 and 9 months of follow up.
measure: 12 - Item Well-Being Questionnaaire (WBQ12)
timeFrame: before the switch to insulin glargine and at 3 and 9 months of follow up.
measure: Glycaemic controll will be asessed by HbA1c values
timeFrame: week 12 and week 40
Secondary outcomes:
measure: Incidence of symptomatic hypoglycemia and severe hypoglycemia
timeFrame: sreening to follow-up phases
Other outcomes:
Locations:
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: sanofi-aventis, Sweden
name: Margareta Olsson-Birgersson
role: STUDY_DIRECTOR
References:
Clinical trial NCT00227227: Study Evaluating Enbrel (Etanercept) in Patients With Ankylosing Spondylitis
Official title: Observational Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-27
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to investigate the incidence of adverse events for patients with AS treated with Enbrel in usual care settings.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ankylosing spondylitis

Exclusion Criteria:

* Contraindications according SmPC

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: MedinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03370627: Effect of Anti-CD303 Antibodies in Autoimmune Diseases
Official title: Effect of Monoclonal Anti-cd303 on the Inhibition of Type I Interferon Secretion in the Peripheral Blood of Patients With Autoimmune Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Disease
Keywords: Autoimmune Diseases
Plasmacytoid Dendritic Cells
Type I Interferons
Antibodies
Anti-CD303
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Laboratoire français de Fractionnement et de Biotechnologies
First posted: 2017-12-12
Enrollment: 138
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 pathogenic role of type I interferons (IFNs) in the development of different autoimmune diseases has been extensively described in the literature. Since plasmacytoid dendritic cells (pDCs) are the main source of type I IFNs, there is evidence of the involvement of pDCs in autoimmune diseases. The CD303 surface protein (also called BDCA-2) is specifically expressed by the pDCs.

The hypothesis leading to the realization of this study is to observe, in vitro, an inhibition of the secretion of the type I IFNs by pDCs in the peripheral blood in patients with autoimmune disease, thanks to the action of the anti-CD303 antibody Developed by the LFB Group, which could reduce the inflammatory response and improve patients with autoimmune disease


Eligibility criteria: Inclusion Criteria:

* Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study data collection procedures
* Patient followed in the department of internal medicine of CHU Lille
* Patient with one of the following autoimmune disease, defined according to international criteria: systemic lupus erythematosus, systemic sclerosis, Gougerot-Sjögren syndrome and idiopathic thrombocytopenic purpura
* Being socially insured

Exclusion Criteria:

* Overlapping syndrome with another autoimmune disease
* Age ≤18 years
* Pregnant or nursing women
* People in emergencies
* Person incapable of consent
* Persons deprived of liberty
* Persons without social security cover

Primary outcomes:
measure: in vitro determination of the level of type I interferons by immunoenzymatic ELISA method.
timeFrame: Baseline
Secondary outcomes:
measure: in vitro determination of the level of type I interferons by immunoassay ELISA (by type of MIA)
timeFrame: Baseline
measure: in vitro determination of the level of type I interferons by ELISA immunoassay method in patients treated or not with immunosuppressive or immunomodulatory treatment.
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: David Launay, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00983827: Aquatic Treadmill Therapy for Improving Gait, Balance, Fitness and Quality of Life in Stroke Patients
Official title: Safety and Efficacy of Aquatic Treadmill Therapy for Improving Economy of Gait, Gait Speed, Balance, Cardiovascular Fitness, and Quality of Life in Ambulatory Adult Stroke Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic or Hemorrhagic Stroke
Hemiparesis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2009-09-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to determine if Aquatic Treadmill Therapy is effective for improving economy of gait, gait speed, balance, and cardiovascular fitness in people with chronic stroke.


Eligibility criteria: Inclusion Criteria:

* Individuals with ischemic or hemorrhagic stroke with hemiparesis who have chronic deficits in gait, falls and/or poor fitness

Exclusion Criteria:

* Subjects with medical co-morbidities that may affect gait and endurance.

Primary outcomes:
measure: Safety
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah, PM&R Division
state: Utah
Study officials:
References:
Clinical trial NCT06142227: The Effect of Reading a Pictorial Storybook on Children's Fear, Anxiety and Emotional Symptoms Before Dental Treatment
Official title: The Effect of Reading a Pictorial Storybook on Children's Fear, Anxiety and Emotional Symptoms Before Dental Treatment: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Fear
Keywords: dental fear
Children
dental anxiety
emotional indicators
pictorial storybook
Lead sponsor: Artvin Coruh University
Sponsor class: OTHER
Collaborators: name: Artvin Coruh University
First posted: 2023-11-21
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to determine the effect of reading a picture storybook on children's fear, anxiety and emotional symptoms before dental treatment.

Detailed description: In children with receiving dental treatment will be randomly divided into two groups: picture storybook group and control. Interventions will be applied for only 1 times. While the illustrated storybook is read to the experimental group, no intervention will be applied to the control group. The children will be assessed before, during and after. Fear, anxiety and emotional symptoms due to dental treatment procedure will be evaluated using the Children's Emotional Indicator Scale, Child Anxiety Scale-Stateness and Children's Fear Scale.

Eligibility criteria: Inclusion Criteria:

* No audiovisual impairment,
* Being open to communication and
* Must be accompanied by a parent.

Exclusion Criteria:

* Having special needs,
* Having an audio-visual impairment,
* Learning difficulties or mental retardation and
* Children whose parents do not agree to participate in the study.

Primary outcomes:
measure: Demographic Information Form
timeFrame: baseline
Secondary outcomes:
measure: Child anxiety Scale-State
timeFrame: baseline
Other outcomes:
measure: Child Fear Scale
timeFrame: baseline
measure: The Children's Emotional Indicator Scale
timeFrame: baseline
Locations:
city: Artvin
country: Turkey
facility: Artvin Oral and Dental Health Centre
Study officials:
affiliation: Artvin Coruh University
name: Ayşe TAŞTAN, 3
role: STUDY_CHAIR
References:
citation: Alsaadoon AM, Sulimany AM, Hamdan HM, Murshid EZ. The Use of a Dental Storybook as a Dental Anxiety Reduction Medium among Pediatric Patients: A Randomized Controlled Clinical Trial. Children (Basel). 2022 Mar 1;9(3):328. doi: 10.3390/children9030328.
citation: Aminabadi NA, Vafaei A, Erfanparast L, Oskouei SG, Jamali Z. Impact of pictorial story on pain perception, situational anxiety and behavior in children: a cognitive-behavioral schema. J Clin Pediatr Dent. 2011 Winter;36(2):127-32. doi: 10.17796/jcpd.36.2.3163251527508338.