louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02885233: Evaluation of a Web-Based Fall Prevention Program on People With Multiple Sclerosis
Official title: Evaluation of a Web-Based Fall Prevention Program on People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Fall Prevention
Multiple Sclerosis
Web-based education
Self-efficacy
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2016-08-31
Enrollment: 30
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: This study evaluates the effectiveness of a web-based fall prevention program called Free From Falls Online (FFFO) on people with multiple sclerosis.

Detailed description: The overarching goal of this study is to evaluate the effectiveness and impact of an online self-management program for preventing falls among people with multiple sclerosis (PwMS). To accomplish this objective, the investigators have designed a web-based fall prevention program called Free From Falls Online (FFFO), based on the traditionally in-person program developed by the National Multiple Sclerosis Society. The specific aims of this study are three-fold: (1) to evaluate the effectiveness of an online fall prevention self-education program by comparing fall frequency between participants and controls; (2) evaluate the impact of FFFO by comparing patient reported measures of physical function, fatigue, self-efficacy, psychosocial illness impact, social participation and satisfaction, and perception of global health between participants and controls; (3) and to determine usability of and satisfaction with FFFO.

Eligibility criteria: Inclusion Criteria:

* MS of any type with no relapse in the previous month
* Self-reported history of 2 or more falls in the previous 2 months
* Ability to walk at least 100 meters with intermittent or unilateral constant assistance (Expanded Disability Severity Scale (EDSS) step \<6.0)
* Daily access a computer and willingness to respond to a daily survey

Exclusion Criteria:

* Medical conditions that would preclude reliable participation or increases risk for injury during the program

Primary outcomes:
measure: Difference in mean change in total falls between intervention and control arms
timeFrame: 5 months
Secondary outcomes:
measure: Difference in patient reported outcomes including physical function, fatigue, self efficacy, psychosocial illness impact, social participation and satisfaction, and perception of global health between intervention and control arms.
timeFrame: 5 months
measure: Quantitative assessment of the web-based program
timeFrame: 8 weeks
measure: Qualitative assessment of the web-based program
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
Study officials:
affiliation: Portland VA Medical Center
name: Michelle H Cameron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05101733: Mold Allergy in Austria: Clinical Relevance of Alternaria Alternata and Related Species
Official title: Pilot Study Regarding Mold Allergy in Austria: Clinical Relevance of Alternaria Alternata and Related Species
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fungal Allergy
Allergy
Keywords: Allergy
Fungal allergy
Alternaria alternata
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are recruited with the help of advertisements on the social media pages of the Austrian Pollen Information Service and on the pollen diary app

Brief summary: Mold allergies are becoming increasingly important among the population. Increasing amounts of fungal spores are analyzed in air-samples because of urbanization, industrialization of food products and climate change. Mold also grows indoor and hence lead to additional health complaints.

Alternaria alternata, and its only major allergen Alt a 1, is the most important fungus for allergy sufferers. Alternaria alternata can not only cause allergic symptoms but can also cause intensified asthmatic symptoms.

Besides Alternaria alternata, there are over 700 other species of the genus Alternaria. The influence of these other species on allergic symptoms is poorly understood.

Furthermore, prevalence and incidence of an allergy to Alternaria alternata among the Austrian population is not known. Estimates range between 1-5% among the Austrian population.

This study aims to further investigate the incidence and characteristics of an allergy to Alternaria in Austria. This will be investigated with the help of participants (50 Alternaria allergy sufferers and 20 non allergic participants), spore counts in Austria and crowd-sourced symptom data.


Eligibility criteria: Inclusion Criteria:

* Participants will be healthy people over 18 years of age. Allergic participants should have an allergic reaction against Alternaria, visible in the Skin-Prick-Test. Furthermore symptom data in the pollen diary of the Austrian Pollen Information Service should be existing

Exclusion Criteria:

* Subjects participating in a pharmacological study, pregnant subjects and subjects with an existing infectious- and/or autoimmune disease

Primary outcomes:
measure: Prevalence, Immunoglobulin-E (IgE)-antibodies to selected Alternaria species
timeFrame: 12 months
Secondary outcomes:
measure: Cytokine-profile (e.g. Interleukin-13, Interleukin-5, Interleukin-10, TNFalpha, IFNgamma) upon Alt a 1 incubation
timeFrame: 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Department of Pathophysiology and Allergy Research
name: Erika Jensen-Jarolim, Univ.-Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01335633: Psychometric Validation of Cognitive Endpoints
Official title: Psychometric Validation of Cognitive Endpoints
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: MS
Neuropsychological tests
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2011-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with Multiple Sclerosis

Brief summary: The study will entail cognitive assessment of a single cohort of patients with Multiple Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no intervention or control group. Each participant will have a caregiver capable of responding to a brief report of observations regarding neuropsychological skills and abilities in the patient.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old (inclusive).
* History of Relapsing-Remitting or Secondary Progressive Multiple Sclerosis
* Physically able to see the testing materials and complete the tests
* Have a family member or caregiver who is capable of consent and willing to complete the MSNQ-Informant questionnaire.

Exclusion Criteria:

* A history of treated or untreated severe mental illness or diagnosis of major depression prior to MS onset.
* Untreated major depression or untreated anxiety disorder.
* History of Attention Deficit/Hyperactivity Disorder, Developmental Learning - Disorder including Mental Retardation.
* History of traumatic brain injury with intracranial bleed, stroke, Alzheimer's disease, Parkinson's disease, Motor Coordination Disorder or other neurologic illness. I understand that if the Investigator believes this would interfere with successful completion of the protocol, I will be excluded.
* A clinically significant relapse within the past 2 months. I have had a serious infection (e.g., pneumonia, septicemia) within the 2 month.
* History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to Study Day 1.
* Active bacterial or viral infection.
* Use of marijuana within 2 months prior to Study Day 1or at any time during the study
* Alcohol consumption within 24 hours of either test session.
* Unable to comply with study requirements.
* Expected survival time of less than 3 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Teaneck
country: United States
facility: Holy Name Hospital Multiple Sclerosis Center
state: New Jersey
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: White Plains
country: United States
facility: Lauren S. Caruso
state: New York
Study officials:
affiliation: Kessler Foundation
name: John DeLuca, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03605433: Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets
Official title: Surgical Coronary Revascularization Outcomes After Oral Anticoagulation or Antiplatelet Strategies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Saphenous Vein Graft Patency
Lead sponsor: Centro Hospitalar e Universitário de Coimbra, E.P.E.
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate whether treatment with oral anticoagulation or oral anticoagulation and aspirin is better than aspirin alone in cardiovascular outcomes and saphenous graft patency in patients submitted to coronary artery bypass graft.


Eligibility criteria: Inclusion Criteria:

* Patients referred to coronary artery bypass graft and at least one saphenous vein graft

Exclusion Criteria:

* Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy
* Stroke within 1 month or any history of hemorrhagic or lacunar stroke
* Estimated glomerular filtration rate (eGFR)\<15 mL/min

Primary outcomes:
measure: MACE
timeFrame: 5 years
measure: Graft Patency
timeFrame: 5 years
measure: Major Bleeding
timeFrame: 5 years
Secondary outcomes:
measure: MACE, cardiovascular death
timeFrame: 5 years
measure: All-cause mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra
Study officials:
References:
Clinical trial NCT05342233: Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection
Official title: Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection: A Real-world, Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spontaneous Isolated Superior Mesenteric Artery Dissection
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: The First Medical Center of Chinese PLA General Hospital
name: West China Hospital
name: Renmin Hospital of Wuhan University
name: Peking University Shenzhen Hospital
name: Affiliated Hospital of Chengde Medical University
name: Second Affiliated Hospital of Nanchang University
name: Henan Provincial People's Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
First posted: 2022-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptoms or history of isolated superior mesenteric artery dissection and confirmed by CTA.

Brief summary: Spontaneous isolated superior mesenteric artery dissection(SISMAD) is an increasingly diagnosed disease. However, prospective, multicenter studies that can provide evidence to support clinical decisions are very limited. This study aims to compare the therapeutic efficacy of conservative and endovascular treatment for SISMAD.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 and above;
2. Isolated superior mesenteric artery dissection with clear symptoms or history and confirmed by CTA
3. Signed informed consent forms, willing to receive treatments

Exclusion Criteria:

1. Symptoms are severe and patients need exploratory laparotomy;
2. Patients with aortic dissection, iliac artery dissection, or autoimmune vasculitis;
3. Patients with mental illness cannot cooperate subjectively;
4. Patients who are allergic to contrast agents, or contraindicated to conservative treatment drugs, and cannot be treated with drugs;
5. Pregnancy and breastfeeding women, or patients who have recent birth plans;
6. Patients who are participating in other clinical projects;
7. Patients are not suitable to participate in this study.

Primary outcomes:
measure: Mortality
timeFrame: up to 5 years
measure: Rate of symptom relief
timeFrame: up to 5 years
Secondary outcomes:
measure: Reintervention rate
timeFrame: Follow-up period（ 5 years）
measure: Recurrence rate
timeFrame: Follow-up period（5 years）
measure: Disease-related complications
timeFrame: Follow-up period（5 years）
measure: Complete remodeling rate of superior mesenteric artery dissection
timeFrame: Follow-up period（5 years）
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT02539433: Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
Official title: Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroendocrine Tumors
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 22
Sex: ALL
Minimum age (years): 23
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Imaging of neuroendocrine (NETs), such as carcinoids and pheochromocytomas (PHEOs), is suboptimal, limiting curative treatment. The investigators wanted to explore the use of PET and F-DOPA i.v. for the localization of these types of neoplasms. The investigators used a similar protocol as they had used for PET (Positron emission tomography) or FDG (Fludeoxyglucose) imaging in oncologic patients. F-DOPA, prepared according to United States Pharmacopeia (USP) guidelines, was approved by the North Shore University Hospital Radiation Safety Committee in 1989 and 1994 for the study of neurological diseases and used uneventfully.

Detailed description: Background: Pre surgical conventional imaging of neuroendocrine tumors (NETs) with CT, MRI, In-111 octreotide or 1-123-MIBG (metaiodobenzylguanidine) scintigraphy has limitations. This pilot study tried to improve the localization of these tumors with F-18-F-DOPA PET scanning.

Methods: The investigators studied 22 patients, the majority referred with clinical diagnosis of carcinoid (9) or NETs (9) and a few with pheochromocytoma/paraganglioma (3). Carbidopa was administered prior to the F-DOPA injection in 12 patients. Comparison was made with prior conventional imaging. The F-DOPA findings, read blindly to the findings of other modalities, were compared with results of subsequent surgery (2), endoscopy (1), or a long-term follow up of mean duration of 49 months (for 20 patients). Two subjects were lost to follow-up.

Eligibility criteria: * Inclusion Criteria:

  * 23 years of age and older
  * Appropriate diagnosis by referring physician
* Exclusion Criteria:

  * Less than 23 years of age
  * Greater than 81 years of age
  * Pregnancy
  * Lactation
  * Prior history of radiation treatment
  * Chemotherapy or anti-tuberculosis medications.

Primary outcomes:
measure: Imaging of Neuroendocrine Tumors
timeFrame: Mean duration 49 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
affiliation: North Shore University Hospital
name: Josephine Rini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neuroendocrinology 2006;83:27-64 DOI: 10.1159/000093339 Published online: May 15, 2006 3rd Annual ENETS Conference March 22-24, 2006, Prague, Czech Republic. Imaging of Neuroendocrine Tumors Zanzi I., Warner R.R.P., Babchyck B., Studentsova Y., Bjelke D., Belakhlef A., Margouleff D., Chaly T. North Shore University Hospital, Manhasset, New York University School of Medicine, New York, N.Y., USA
Clinical trial NCT04134533: Comparison of Motor Functions and Quality of Life According to Feeding Type in Children With Cerebral Palsy
Official title: Motor Functional Level and Quality of Life According to Feeding Types in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 35
Sex: ALL
Minimum age (years): 5
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: Children with Cerebral Palsy

Brief summary: The aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy.

Detailed description: The aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy. Children will be divided into two groups: children with oral feeding and children with non-oral feeding, according to Functional Oral Intake Scale. Gross Motor Function Classification System will be used for classify children according to gross motor function, Gross Motor Function Measurement will be used for evaluate gross motor functions, and parent-reported Pediatric Quality of Life Inventory will be used for evaluate quality of life of children. To measure caregivers' anxiety and depression levels will be assessed by using Beck Depression Inventory and Beck Anxiety Inventory. Parametric or non-parametric tests will be applied according to the variables distribution. Through this analyses, determination of the difference between feeding type groups and other categorical and continuous variables will be decided.

Eligibility criteria: Inclusion Criteria:

* Children who were diagnosed with CP
* Aged between 5-18 years
* Must have cooperation
* Feed by orally or non-orally

Exclusion Criteria:

* Having other accompanying neurodegenerative diseases.
* Acute respiratory tract infection
* Complications of enteral feeding

Primary outcomes:
measure: Gross motor Function Measurement
timeFrame: 2 months
Secondary outcomes:
measure: Gross Motor Function Classification System
timeFrame: 2 months
measure: Pediatric Quality of Life Inventory
timeFrame: 2 months
measure: The Turkish version of the Beck Depression Inventory and Beck Anxiety Inventory
timeFrame: 2 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT02600533: Increasing Minority Participation in Clinical Trials
Official title: Increasing Minority Group Participation in Clinical Trials a Randomized Controlled Study of an Office-based Educational Video
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Trial
Keywords: minority group recruitment
stages of implementation
clinical trials education
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Meharry-Vanderbilt Alliance
First posted: 2015-11-09
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation. This study will also determine the feasibility of implementing an office-based video educational program.

Detailed description: Clinical trials are essential to scientific discovery and are critical to translating research in to practice. Despite their significance, clinical trial participation rates remain low, especially among underrepresented minority groups. Several barriers exist to minority group participation in clinical trial, one of which lack of awareness about clinical trials. Video educational programs show promise as an effective strategy to increase knowledge and clinical trial participation. The specific aims are as follows:

1. Measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation.
2. Determine the feasibility of implementing an office-based video educational program.

Eligibility criteria: Inclusion Criteria:

Participants will be patients of Vanderbilt-Ingram Cancer Center (VICC) with a diagnosis of cancer Participants will have no previous history of clinical trial research participation

Exclusion Criteria:

* Previous history of clinical trial research participation

Primary outcomes:
measure: study feasibility
timeFrame: 12 months
Secondary outcomes:
measure: Clinical trial participation
timeFrame: 12 months
measure: Clinical trial knowledge survey
timeFrame: 7-10 days
measure: Likelihood to participate survey
timeFrame: 7-10 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Meharry-Vanderbilt Alliance, Vanderbilt University Medical Center
name: Consuelo H. Wilkins, MD
role: PRINCIPAL_INVESTIGATOR
References: