louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04132297: Asthma Academy: Use of Simulation and Telehealth to Empower Family Caregivers
Official title: Asthma Academy: Use of Simulation and Telehealth to Empower Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burnout
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Josiah Macy, Jr. Foundation
First posted: 2019-10-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this project is to implement and evaluate a novel intervention for low-income families to reduce the burden of caregivers of a child with asthma.


Eligibility criteria: Inclusion criteria:

1. Must be age 18 or older
2. Able to speak and read English or Spanish
3. Have a smartphone or computer with active service
4. Care for a child with asthma between ages 5-12
5. Agree to participate

Exclusion criteria:

1. Age less than 18
2. Inability to speak and read English or Spanish
3. Does not have a smartphone or computer with active service
4. Child does not have asthma
5. Care for a child less than 5 or greater than 12
6. Decline to participate
7. Prisoners

Primary outcomes:
measure: Change in Caregiver's asthma knowledge
timeFrame: Baseline, Week 3
measure: Change in Caregiver's sleep
timeFrame: Baseline, Week 3
measure: Change in Caregiver's anxiety
timeFrame: Baseline, Week 3
measure: Change in Caregiver's depressive symptoms
timeFrame: Baseline, Week 3
measure: Performance of DNP students conducting the Teleheath Visits
timeFrame: Week 3
measure: Correlation of DNP student performance with family caregiver outcome
timeFrame: Week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Cynthia Foronda
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foronda C, Prather S, Snowden K, Gonzalez JM, Gattamorta KA, Lee J, Gonzalez JE, Cardenas M. Asthma academy: A student nurse-led telehealth education program for low-income family caregivers of children with asthma. Nurs Open. 2022 Mar;9(2):1486-1496. doi: 10.1002/nop2.1123. Epub 2021 Dec 16.
Clinical trial NCT04649697: Rebamipide (Regular & Nanoparticulated) vs. Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients
Official title: Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this intervention study is to compare the effect of topical Rebamipide (regular and nanoparticulated) to topical Clobetasol propionate in management of Methotrexate induced oral mucositis in patients with rheumatoid arthritis.

Detailed description: A random sample of patients diagnosed with rheumatoid arthritis attending at the Rheumatology clinic in faculty of Medicine, Cairo University Hospital, will be enrolled by the investigator in the study in a consecutive order after being examined for methotrexate induced oral ulceration by means of history and clinical examination.

Since oral mucositis associated with Methotrexate include production of free radicals, increase of inflammatory cytokines, and alteration of intracellular signal transduction, this suggests that Rebamipide should be useful for its treatment and prevention. Thus, this RCT will be the first to evaluate the treatment of Methotrexate-induced oral mucositis using Rebamipide and Rebamipide nanoparticles in patients with rheumatoid arthritis.

Eligibility criteria: Inclusion Criteria:

* Patient who agreed to sign the informed consent.
* Age: 20-70 years old.
* Gender: males and females
* RA patients treated with MTX and suffering from MTX-induced oral ulceration.

Exclusion Criteria:

* Patients refused to sign the informed consent.
* Pregnant or lactating females in their child bearing age group.
* patients with known or suspected history of hypersensitivity to any of the ingredients of the preparation of the drugs used.
* Systemic disease: such as uncontrolled diabetes mellitus, auto-immune diseases known to cause oral ulceration, renal or liver dysfunction or any other condition considered risky by the clinician.
* Patients treated with any medication for the condition at the time of setting.
* Salivary gland diseases.
* Malignancy.

Primary outcomes:
measure: change in the Clinical improvement of oral ulcers
timeFrame: assessment will be at baseline, 2 weeks and 4 weeks
Secondary outcomes:
measure: Subjective degree of pain
timeFrame: Pain assessment will be daily for the first week then at 2 weeks and 4 weeks.
measure: size of oral ulcer
timeFrame: assessment at 0, 2 weeks and 4 weeks
measure: healing time of the ulcer
timeFrame: assessment at 0, 2 weeks and 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT01826097: Improving Sensitivity of Urine Cytology for Bladder Cancer
Official title: Non-Invasive Vibrational Device to Improve Sensitivity of Urine Cytology for Bladder Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bladder Cancer
Keywords: Cytology
Whole body massage vibration
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Can a commercially available vibrating chair increase the number of urothelial cells in a urine sample of healthy participants non-invasively? The investigators plan is participants will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting in the vibrating chair for one hour. The control group will alternate 15 minutes of drinking eight fluid ounces of water and 15 minutes of sitting in a non-vibrating chair for one hour. Then, urine samples will be collected and examined for urothelial cell concentration for both groups.


Eligibility criteria: Inclusion Criteria:

* Only adult male subjects who will not have surgery within a period of 2 weeks.
* Over the age of 18
* Have had a confirmed diagnosis of stage 0-4 transitional cell carcinoma within the last 30 days

Exclusion Criteria:

* Cognitive impairment resulting in the inability to give informed consent
* Lack of spoken and written English resulting in the inability to give informed consent
* Presence of infectious disease
* Insulin dependent diabetes mellitus
* Endogenous osteosynthetical material implants
* Knee or hip prosthesis
* Pacemaker
* Epilepsy
* Musculo-skeletal disorders
* Weight in excess of 250 pounds
* Poor circulation

Primary outcomes:
measure: Number of Cancer Cells
timeFrame: up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Trinity Bivalacqua, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: John J Kim, BS
role: STUDY_CHAIR
References:
Clinical trial NCT01306097: Zinc Supplementation and Severe and Recurrent Diarrhea
Official title: Evaluating the Impact of 3 Months Daily Zinc Supplementation on Incidence of Severe and Recurrent Diarrhea in 6 to 36 Months Age Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Keywords: Zinc Supplement
Diarrhea
Sever Diarrhea
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and recurrent diarrhea in 6 to 36 months age children in Bandarabbaas

Detailed description: Evaluating the impact of 3 months daily zinc supplementation on incidence of severe and recurrent diarrhea in 6 to 36 months age children in Bandarabbaas in 2009

Eligibility criteria: Inclusion Criteria:

* All 6 to 36 months old children without diarrhea at the time of study and without disease such as celiac
* Inflammatory bowl disease and hypersensitivity to milk

Exclusion Criteria:

* Diarrhea at the time of the study and background disease such as celiac, IBD or hypersensitivity to milk

Primary outcomes:
measure: Diarrhea
timeFrame: 1 years
Secondary outcomes:
measure: Admission for diarrhea
timeFrame: 1 year
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Hormozgan University of medical sciences
state: Hormozgan
Study officials:
affiliation: Hormozgan University of Medical Sciences
name: Marzie Barchinejad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04809597: Does Notch Regulate Glioma Proliferation ?
Official title: Study of the Activity and Role of Notch1 Signalling in Glioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Keywords: pathologist-graded gliomas
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases with brain diffuse low grade and high grade gliomas (glioblastomas)

Brief summary: The investigators showed in 2015 (Guichet et al) that the Notch1 pathway has an anti-proliferative role on glial brain tumors. In this project, the investigators investigated which genes downstream of Notch1 pathway activation produce the anti-proliferative effect. The investigators hypothesized that the SNAI2 and TAL1 genes act downstream of Notch1

Detailed description: Main objectives:

To examine the expression of TAL1 and SNAI2 in protein extracts and glioma sections of different grades (glioblastomas and diffuse low-grade tumors).

To examine the effect of overexpression of Tal1 and Snai2 in high grade glioma cultures.

To show the expression of Tal1 and SNAI2 by tumor cells by FISH technique. Show that TAL1 and SNAI2 could be regulated by endothelial cells

Eligibility criteria: Inclusion criteria:

* Patient ≥18 years old
* Patient affected with brain glioma classified according to WHO 2016 classification

Exclusion Criteria:

* Patient who reject the study protocol
* Radiotheray or chemotherapy treatment

Primary outcomes:
measure: Effect of Notch1 activation on Tal1
timeFrame: 1 day
measure: Snai2 gene and protein expression
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Jean-Philippe Hugnot
role: STUDY_DIRECTOR
References:
Clinical trial NCT00215397: Study in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Formoterol
Fumarate
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which dose of the investigational drug is the most safe and effective in the treatment of asthma compared to the control drug.


Eligibility criteria: Inclusion Criteria:

* Patients with a history of asthma

Exclusion Criteria:

* Current asthma exacerbation or recent asthma exacerbation, requiring hospitalization
* History of smoking
* Debilitating systemic and/or life-threatening diseases.

Primary outcomes:
measure: The primary outcome variable is the measure of lung function.
Secondary outcomes:
measure: Secondary outcomes include change in lung function, as well as in vital signs.
measure: Physical exams, AE reporting, etc.
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Medford
country: United States
facility: Research Site
state: Oregon
Study officials:
References:
Clinical trial NCT03698097: Patient Surveys - What Patients Want
Official title: Patient Surveys - What Patients Want
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Survey
Keywords: quality management
paper questionnaires
satisfaction surveys
survey technique
online questionnaires
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 745
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data were collected from a random sample of patients after out- or inpatient treatment at the DOTS

Brief summary: This study is to gain insight into patients' preferences considering satisfaction surveys, specifically asking for their most pressing topics and their preferred survey technique.

Detailed description: The practice of patient surveys for quality management is revised at the University Hospital Basel (USB). One aspect is a more versatile data acquisition via online portals and/or paper questionnaires, another aspect is the content of questions and the assessment of demographic data. In this situation a tentative survey on their preferences in this context was realised in patients who were treated in autumn 2016 at the Department of Orthopaedics and Trauma Surgery (DOTS) using a cover letter informing them about the nature of the survey. They were asked to provide few basic demographic data, they were furthermore asked whether they favoured surveys by the USB and if so with which focus. Finally they had the option to name three central topics for feedback and to quantify the number of questionnaires they had so far received by the USB. The survey could be completed in a paper and survey monkey based internet version accessible via a Quick Response (QR) code or link.

Eligibility criteria: Inclusion Criteria:

* All data from completed survey sheets (paper questionnaires) and online forms are included

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: patients' preferences considering preferred survey technique
timeFrame: after out- or inpatient treatment at the DOTS in a three months period in autumn 2016
Secondary outcomes:
measure: patients' preferences asking for their most pressing topics
timeFrame: after out- or inpatient treatment at the DOTS in a three months period in autumn 2016
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Trauma Surgery (DOTS).
Study officials:
affiliation: Department of Orthopaedics and Trauma Surgery (DOTS).
name: Franziska Saxer, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06264687: Hepcidin After Intravenous Iron Treatment
Official title: Serum Hepcidin Response After Intravenous Iron Therapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Iron Deficiency (Without Anemia)
Lead sponsor: Hausarztpraxis Brauereistrasse
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: iron deficient non-anemic women

Brief summary: The aim of this study is to investigate the hepcidin hormone response after intravenous iron administration.

Detailed description: Intravenous iron is often administered when peroral iron is insufficient to correct iron-deficiency or not tolerated. Few studies have shown a relationship between pretherapeutic serum hepcidin levels and response to intravenous iron infusion: the lower the pre-infusion hepcidin level, the fewer red blood cell concentrates were used to correct anaemia. However, there are no studies investigating hepcidin levels after intravenous iron supplementation. Furthermore, some studies showed an increase in hepcidin 24 hours after ingesting oral iron supplements, impairing the iron uptake the next day. However, how long hepcidin is increased after intravenous iron administration is unknown. Prolonged serum hepcidin concentrations after an iron infusion would reduce intestinal iron absorption and continued, simultaneous oral iron therapy would be pointless.

This study investigates whether and how serum hepcidin concentrations change after intravenous iron therapy. Women with iron deficiency (serum ferritin below 30ng/ml) without anaemia (hemoglobin \>117g/l) receive 500mg iron (Ferinject®) intravenously. Serum hepcidin levels are measured before therapy (day 0) 2 days (day 2) and 7 days (day 7) after infusion.

Eligibility criteria: Inclusion Criteria:

* informed consent as documented by signature
* iron-deficiency (serum ferritin \<30ng/ml)
* female gender
* premenopausal
* age \>18 years
* body mass index (BMI) in normal range (18-25 kg/m²)
* the participant is linguistically and cognitively able to understand the study procedure

Exclusion Criteria:

* anaemia (hemoglobin \<117g/l)
* allergy or contraindications for iron infusions
* anamnestic current pregnancy
* breastfeeding
* chronic inflammatory diseases (e.g. colitis)
* liver disease (alanine transaminase (ALT) \>35 U/l)
* increased C-reactive protein (CRP) (\>5mg/l)
* intake of dietary supplements containing iron (last 7 days)

Primary outcomes:
measure: Serum Hepcidin Change
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01370187: Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing
Official title: Montelukast for Acute Bronchiolitis and Postbronchiolitis Viral Induced Wheezing in Infants 3 to 12 Months of Age in Bandar Abbas Children' Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Wheezing
Cough
Keywords: Bronchiolitis
Postbronchiolitis wheezing
Montelukast
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-06-09
Enrollment: 146
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to evaluate the effect of Montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in Bandar Abbas Children' hospital.

Detailed description: All the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.

Eligibility criteria: Inclusion Criteria:

* infant in 3-12 months of age with first episode of wheezing or bronchiolitis
* written informed consent by parents

Exclusion Criteria:

* Previous wheezing episode or confirmed asthma or bronchiolitis
* recent bronchodilator use
* immune deficient
* immunosuppressive drug use
* croup or pneumonia diagnosis
* loss of follow up

Primary outcomes:
measure: Respiratory Distress Severity Score (RDSS)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes:
measure: average number of cough daily= as expressed parents during visits
timeFrame: 6 months
measure: Wheezing severity in the physical examination by physician
timeFrame: 6 Months
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Hormozgan University of Medical Sciences (HUMS)
state: Hormozgan
Study officials:
affiliation: Hormzgan University of Medical Sciences (HUMS)
name: Ali Asghar Parhiz, Resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01634087: A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis
Official title: A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of Escalating Doses of Oral Itacitinib in Subjects With Stable, Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study of itacitinib in patients with chronic plaque psoriasis. This study will evaluate safety and efficacy parameters of itacitinib.


Eligibility criteria: Inclusion Criteria:

* Subjects with chronic plaque psoriasis aged 18 to 75 who have had insufficient response to topical agents, and who meet the psoriasis assessment expectations as defined in the study protocol

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively
* Subjects treated with leflunomide or other biological therapies to treat psoriasis and all JAK-STAT inhibitors within 12 weeks prior to first dose of study drug

Primary outcomes:
measure: Safety and tolerability of itacitinib as measured by changes in frequency and severity of adverse events, ECGs, physical examination, vital signs, and clinical laboratory evaluations.
timeFrame: Approximately two months.
measure: The mean percent change from baseline in static Physician's Global Assessment (sPGA) on the day 28 visit.
timeFrame: Approximately 28 days.
Secondary outcomes:
measure: Percentage of subjects achieving static Physician's Global Assessment (sPGA) of 1 or 2 at each scheduled visit.
timeFrame: Day 1, Day 8, Day 15, Day 28 and Day 56 (approximately two months).
measure: Preliminary Pharmacokinetic (PK) collections.
timeFrame: Following 15 days of therapy.
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Clinton
country: United States
state: Minnesota
city: Fridley
country: United States
state: Minnesota
city: Rochester
country: United States
state: New York
city: Moncton
country: Canada
state: New Brunswick
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
Study officials:
affiliation: Incyte Corporation
name: Victor Sandor, MD
role: STUDY_DIRECTOR
References: