louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02415751: The Impact of a Heart Failure Review on Self-Care Knowledge, Adherence and Clinical Outcomes
Official title: The Impact of a Heart Failure Review on Self-Care Knowledge, Adherence and Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: CHI Nebraska Heart
First posted: 2015-04-14
Enrollment: 57
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults ages 19 and older with heart failure

Brief summary: This study is assessing the effects of a new heart failure self-care education program in the Nebraska Heart Institute Heart Improvement Clinic. The new education program will consist of an initial intensive self-care education session with the Principal Investigator or her nurse practitioner. Topics to be discussed include medications, sodium and fluid consumption, alcohol restriction, exercise, preventive behaviors, and monitoring of signs and symptoms. As recommended in the ACCF/AHA guidelines, this education will be repeated on an annual basis as studies have shown that the impact of HF education is not always durable and must be a continual process. This study will assess the impact of this review on their medication knowledge, disease state knowledge, quality of life, disease state progression and clinical outcomes such as ejection fraction and number of hospitalizations.

Detailed description: This is an observational study as all patients in the heart failure clinic, regardless of whether or not they will choose to be in the study, will receive heart failure self-care education from now on.

Eligibility criteria: Inclusion Criteria:

* Males and females ages 19 and older
* Able to speak, read and understand English and able to understand and provide informed consent
* Diagnosis of cardiomyopathy and/or HF, preserved or reduced ejection fraction

Exclusion Criteria:

* Patients not-responsible for self-care.
* Inability to provide written informed consent.
* Co-morbid condition with an expected survival of less than six months.

Primary outcomes:
measure: number of hospitalizations
timeFrame: 12 months
Secondary outcomes:
measure: ejection fraction
timeFrame: 12 months
measure: change in heart failure medication knowledge
timeFrame: 12 months
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Katie Packard, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05758051: Management of Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur Case Report.
Official title: Management of Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur Case Report.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Slipped Capital Femoral Epiphysis
Keywords: Slipped capital femoral epiphysis
SCFE
coxa vara
fracture neck of femur
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 1
Sex: MALE
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: subtrochanteric valgus osteotomy
Primary purpose: TREATMENT

Brief summary: Slipped Capital Femoral Epiphysis (SCFE) on Top of Fixed Fracture Neck of Femur managed by subtrochanteric valgus osteotomy

Detailed description: The incidence of Slipped capital femoral epiphysis (SCFE) after management of femoral neck fracture in pediatrics is very rare. In this case report, a 9-year-old female child sustained left sided femur neck fracture after a motor car accident. The fracture was fixed by two cannulated screws and healing with mild varus occurred after 1.5 months. However, progressive slippage of femoral epiphysis was observed. This was treated by subtrochanteric valgus osteotomy

Eligibility criteria: Inclusion Criteria:

* scfe on top NOF

Exclusion Criteria:

* pathological fracture

Primary outcomes:
measure: modified McKay's criteria
timeFrame: one year
Secondary outcomes:
measure: Rust union score
timeFrame: one year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: faculty of medicine Assiut university
Study officials:
affiliation: Assiut University
name: Hesaham M Elbaseet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yerli M, Ocak O, Yuce A, Bayraktar TO, Kir MC, Imren Y, Dedeoglu SS, Gurbuz H. Retrospective analysis of 35 pediatric femoral neck fractures. Eur J Orthop Surg Traumatol. 2022 Oct;32(7):1385-1390. doi: 10.1007/s00590-021-03126-6. Epub 2021 Sep 20.
citation: Li H, Zhao L, Huang L, Kuo KN. Delayed Slipped Capital Femoral Epiphysis After Treatment of Femoral Neck Fracture in Children. Clin Orthop Relat Res. 2015 Aug;473(8):2712-7. doi: 10.1007/s11999-014-4067-y. Epub 2014 Nov 27.
Clinical trial NCT04554251: Global Impact of COVID-19 on Pulmonology Special Units
Official title: Global Impact of COVID-19 on Pulmonology Special Units (Bronchoscopy, Thoracoscopy, Ultrasonography and Sleep Lab)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Global Impact
Pulmonology
Keywords: Bronchoscopy
Thoracoscopy
Thoracic ultrasonography
Sleep Lab
Global impact
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: invited pulmonology units; bronchoscopy, thoracoscopy, chest ultrasonography and sleep lab

Brief summary: The COVID-19 pandemic is having a profound impact on the world. As of May 18, 2020, there were 4,889,287 confirmed cases and 322,683 deaths globally. The healthcare system is wrestling with a virus that threatens to overwhelm hospital capacity, while simultaneously confronting an unprecedented reduction in elective and non-essential care.

A survey by the American Cancer Society showed that 50% of cancer patients and survivors reported some impact to their healthcare due to the COVID-19 epidemic.

A recent survey was conducted by Forbes et al to evaluate the changes in GI and endoscopy practices in North America.

However, the impact of this epidemic on Pulmonology units ( bronchoscopy, thoracoscopy, ultrsonography and sleep lab) globally has not been studied.


Eligibility criteria: Inclusion Criteria:

* Working registered invited pulmonology units; governmental, university, private

Exclusion Criteria:

* non pulmonary medicine registered units

Primary outcomes:
measure: global impact of COVID-19 on baseline patients number
timeFrame: 6 months
measure: measure the changes in practice in each unit
timeFrame: 6 months
measure: frequency of SARS-CoV-2 infection in healthcare workers
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Aliae Mohamed-Hussein
Study officials:
affiliation: Assiut University
name: Aliae Mohamed-Hussein
role: STUDY_CHAIR
References:
Clinical trial NCT03380351: Specifying Interventions From the Sickle Cell Disease Implementation Consortium (SCDIC)
Official title: The Implementation of Cognitive Screening and Educational Support to Improve Outcomes of Adolescents and Young Adults With Sickle Cell Disease: From Clinic to the Community and Back
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia, Sickle Cell
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-12-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is focused on gathering data about the interventions planned and delivered from three different stakeholders of each site.

Brief summary: The goal of this study is to specify the interventions, implementation strategies and control conditions from the Sickle Cell Disease Implementation Consortium (SCDIC) using a mixed-methods approach to study site materials and conduct semi-structured qualitative interviews with site representatives (N=3 per site). We focused on the Emergency Department Working Group from the SCDIC working groups.

Detailed description: The long-term goal of this line of research is to identify the most effective components of SCD interventions while also identifying effective implementation strategies informed by a systematic and rigorous work done by the members of the SCDIC consortium to improve the quality of life of people with SCD, a life-threatening hematological disorder. This study aims to collect detailed information about the planned interventions, the implementation strategies and the control conditions from each site.

Eligibility criteria: Inclusion Criteria:

* three representatives of each of the SDIC sites: the Principal Investigator, and two people nominated by the PI.

Exclusion Criteria:

* none

Primary outcomes:
measure: SCDIC Framework of Interventions
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ana Baumann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baumann AA. Commentary: Adapting and Operationalizing the RE-AIM Framework for Implementation Science in Environmental Health: Clean Fuel Cooking Programs in Low Resource Countries. Front Public Health. 2020 Jun 9;8:218. doi: 10.3389/fpubh.2020.00218. eCollection 2020. No abstract available.
citation: Baumann AA, Belle SH, James A, King AA; Sickle Cell Disease Implementation Consortium. Specifying sickle cell disease interventions: a study protocol of the Sickle Cell Disease Implementation Consortium (SCDIC). BMC Health Serv Res. 2018 Jun 27;18(1):500. doi: 10.1186/s12913-018-3297-1.
Clinical trial NCT05602051: Mindfulness-based Virtual Reality Intervention
Official title: Efficacy of Mindfulness-based Virtual Reality Intervention on the Symptoms Associated With Hematologic Neoplasms Patients During Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Neoplasms
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Through virtual reality technology and mindfulness therapy, we can intervene the patients with Hematologic Neoplasms during chemotherapy, hoping to improve their symptoms and self-efficacy.

Detailed description: In recent years, the intervention method of giving mindfulness has achieved good results in the management of symptoms related to cancer patients, but the compliance of patients with conventional mindfulness intervention is low. The virtual reality intervention based on mindfulness can effectively mobilize the enthusiasm of patients to participate in research and the compliance of mindfulness training. We aim to combine virtual reality with mindfulness intervention to intervene patients with hematologic neoplasms during chemotherapy, To improve their symptoms.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Hematologic Neoplasms(leukemia, lymphoma or multiple myeloma) and receiving chemotherapy
* Hospitalized for more than 4 weeks
* Have normal communication ability, clear consciousness, and willing to participate in this study

Exclusion Criteria:

* People are cognitive dysfunction and audio-visual dysfunction
* Have mental problems or have reported mental disorders

Primary outcomes:
measure: MDASI-C
timeFrame: up to 7 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: up to 7 weeks
Secondary outcomes:
measure: the self-management efficacy scale (C-SUPPH)
timeFrame: up to 7 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: yuxi Zhang
role: STUDY_DIRECTOR
References:
Clinical trial NCT00338351: Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Official title: To Assess Reactogenicity and Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Co-administered With GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (Infanrix™ Hexa) at 2, 4 and 6 Months of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-20
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Three dose primary vaccination study of reactogenicity and immunogenicity in healthy infants between 6-12 weeks of age at the time of the first vaccination against Streptococcus pneumoniae.

Detailed description: Test groups: 2 (120 subjects/group). 1 group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa combined vaccine; Control group receiving GSK Biologicals' Havrix + DTPa combined vaccine

Eligibility criteria: Inclusion Criteria:

* Male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.

Primary outcomes:
measure: After each dose: Grade 3 AEs
Secondary outcomes:
measure: After each dose: solicited/unsolicited AEs (4/31 days),SAEs (whole study); 1 month post 3: antibody concns to vaccine antigens
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lagos RE, Munoz AE, Levine MM, Lepetic A, Francois N, Yarzabal JP, Schuerman L. Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children. Hum Vaccin. 2011 May;7(5):511-22. doi: 10.4161/hv.7.5.14634. Epub 2011 May 1.
Clinical trial NCT02977351: Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms
Official title: Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms in Chronic Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Chronic Periodontitis
Keywords: Periodontopathogenic microorganisms
Non-surgical periodontal treatment
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Determine the relationship between the systemic indications of atherosclerosis by means of the change in the ratio of periodontopathogenic microorganisms following periodontal treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.

Detailed description: It has been aimed in this study to compare 1) the change in periodontal status; 2) the change of the periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) in dental plaque samples, 3) the changes of the amounts of HDL, LDL, hs-CRP white blood cell levels (WBC), platelet levels (PLT), creatinine, and fibrinogen in serum samples; and 4) the correlation between periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) and HDL, LDL, hs-CRP WBC, PLT, creatinine, and fibrinogen in patients that have been diagnosed with atherosclerosis-chronic periodontitis and systemic healthy patients and patients diagnosed with chronic periodontitis, following non surgical periodontal treatment.

Eligibility criteria: Inclusion Criteria:

* had no systemic disease,
* had not used any antibiotics
* had not used medications with an impact on the immune system,
* had not received any periodontal and/or medical treatment within the last 6 months.

Exclusion Criteria:

* smokers of cigarettes or other tobacco products,
* pregnant or breastfeeding,
* non-stable cardiovascular condition.

Primary outcomes:
measure: Periodontopathogenic microorganism levels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05773651: Rare Tumours in Children and Adolescents (STEP)
Official title: Rare Tumours in Children and Adolescents (STEP 2.0) - Register for the Documentation of Rare Tumours in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rare Diseases
Keywords: Epidemiological data collection
Rare tumors in children
Rare tumors in adolescents
Clinical data collection
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 10000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with rare solid tumors from primary care clinic, university hospitals, specialty centers, ...

Brief summary: The aim of the STEP registry is to collect and evaluate experience and data on the diagnosis and treatment of rare childhood tumors in order to use the knowledge gained to improve the treatment prospects for our patients. The rarity of a disease should not be a disadvantage for the young patients.

Detailed description: The objective of the STEP registry is to optimise the diagnosis and treatment of patients with rare tumour diseases in childhood and adolescence. Therefore, a continuous prospective collection of clinical data on rare paediatric tumours is conducted to improve the understanding of these tumours. Beyond analysis of clinical data, further scientific research on the biological and molecular genetic characteristics of these tumours is performed. These data and a close collaboration with international partners, especially the European EXPeRT group, enable the improvement of treatment recommendations for these tumours along with establishment a global interdisciplinary network of rare tumour specialists.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a rare solid tumor
* Age at diagnosis: Neonatal period to 18 years (In the case of young adults, registration in the database and/or referral to advisory contact persons within the framework of the competence network can take place upon request and after declaration of consent.)
* Information, education, written consent of the patient or the guardian
* Not recorded in any of the existing clinical studies/ registers of the German Society for Pediatric Oncology and Hematology (GPOH)

Exclusion Criteria:

* Registration of the tumor diagnosis in a prospective therapy study/ another clinical registry of the GPOH
* Lack of information, explanation and/or written consent of the patient or the legal guardian.

Primary outcomes:
measure: Event-free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
Study officials:
affiliation: University Hospital Tübingen
name: Ines Brecht, PD Dr. med.
role: STUDY_DIRECTOR
affiliation: Clinic for Pediatric and Adolescent Medicine at Dortmund Hospital
name: Dominik Schneider, Prof. Dr. med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00576251: TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Inflammation Associated With Blepharaconjunctivitis
Keywords: Ocular inflammation
blepharaconjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 221
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis


Eligibility criteria: Inclusion Criteria:

* Ocular inflammation associated with blepharaconjunctivitis

Exclusion Criteria:

* ocular allergy
* ocular disorders that would preclude safe administration of test article

Primary outcomes:
measure: Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)
timeFrame: Day 4 - Test Of Cure (TOC) compared to Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston
state: Texas
Study officials:
affiliation: Alcon Research
name: Michael Brubaker, BSN MPH
role: STUDY_DIRECTOR
References: