louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06586723: Impact Trial of Helping Educational Leaders Mobilize Evidence
Official title: Impact Trial of Helping Educational Leaders Mobilize Evidence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Development
Child Behavior
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: All schools that participate in the study will receive PBIS. Additionally, half of the schools will be randomized to receive HELM, an additional implementation support intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Social, emotional, and behavioral (SEB) problems occur frequently among elementary school students, dramatically impede student outcomes, and have been exacerbated by the COVID-19 pandemic. Evidence based practices exist to address student SEB needs, prevent problems, and ensure academic success. However, the implementation of these programs in schools is frequently incomplete, uneven, and occurs with insufficient fidelity to ensure positive effects for students due to significant implementation barriers across multiple levels. The purpose of this Impact Trial is to test the effectiveness of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy in school-wide implementation of a Tier 1 evidence-based practice (EBP) - Positive Behavioral Interventions and Supports (PBIS).


Eligibility criteria: Inclusion Criteria:

* School Districts: School districts in Washington State committed to implementing PBIS in its elementary schools
* Educators: Educators working in a public elementary school within an enrolled school district.

Exclusion Criteria:

* Schools with previous HELM exposure will be excluded

Primary outcomes:
measure: PBIS Fidelity (Tiered Fidelity Inventory)
timeFrame: Baseline, 9 months, 12 months
Secondary outcomes:
measure: Implementation Leadership: School Implementation Leadership Scale (SILS)
timeFrame: Baseline, 9 months, 12 months
measure: Implementation Climate: School Implementation Climate Scale (SICS)
timeFrame: Baseline, 9 months, 12 months
measure: Implementation Cost
timeFrame: Baseline, 9 months, 12 months
measure: Academic Engagement, Prosocial Behavior, and Problem Behavior: Modified Direct Behavior Rating (DBR)
timeFrame: Baseline, 9 months, 12 months
measure: Student Academic Outcomes
timeFrame: Baseline, 9 months, 12 months
measure: Student Disciplinary Incidents
timeFrame: Baseline, 9 months, 12 months
measure: Student Attendance Rates
timeFrame: Baseline, 9 months, 12 months
measure: HELM Fidelity
timeFrame: Baseline, 9 months, 12 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jill Locke, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Aaron Lyon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01830023: Vitality Trial - Sampling Examination Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Event
Keywords: cardiac ultrasound
vitality
data
patients
examined
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 2019
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are examined in the department of cardiology, university hospital Aachen

Brief summary: This study´s aim is to collect data of vitality diagnosis. A cardiac ultrasound examination will be done and the data will be compared to the other examinations.


Eligibility criteria: Inclusion Criteria:

* MRI exmination outcome: positive Late Enhancement, proof of infarction scars by contrast agent.

Exclusion Criteria:

* no exclusion criteria as patients are asked to participate after evaluating the MRI examination outcome

Primary outcomes:
measure: vitality data
timeFrame: 1 day (at time of examination)
Secondary outcomes:
Other outcomes:
Locations:
city: Aacehn
country: Germany
facility: Department of Cardiology, university hospital
state: North Rhine Westfalia
Study officials:
References:
Clinical trial NCT00233623: Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer
Official title: A Randomised, Non-Comparative, Multicentre, Phase II, Parallel-Group Trial Of ZD1839 (Iressa™) In Combination With 5 Fluorouracil, Leucovorin And Cpt-11 (Irinotecan) In Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 190
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 aim of the study is to determine if Iressa added to chemotherapy with Irinotecan, 5Fluorouracil and Leucovorin can prolong the period of time without any disease worsening (Time to Progression) in patients with metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic colorectal cancer
* Presence of measurable metastases
* No previous treatment for metastatic cancer

Exclusion Criteria:

* No presence of Central Nervous System metastases
* No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

Primary outcomes:
measure: Time to progression (6 months after Last patient in)
Secondary outcomes:
measure: Objective Response Rate, Duration of Response, Disease control rate, Overall Survival, (6 months after Last patient in)
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Research Center
city: Bergamo
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Cremona
country: Italy
facility: Research Site
city: Cuneo
country: Italy
facility: Research Site
city: L'Aquila
country: Italy
facility: Research Site
city: La Spezia
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Pescara
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Venezia
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Italy Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00476723: HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection
Official title: Generation of HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection Receiving HBV-active Antiretroviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Hepatitis-B
Keywords: HIV infection
Hepatitis coinfection
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Kirby Institute
name: Ministry of Health, Thailand
First posted: 2007-05-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV/Hepatitis B coinfected patients using at least one hepatitis active medications in HAART regimen

Brief summary: The trial will randomise HIV/HBV co-infected individuals to different HBV-active antiretroviral therapy treatment regimens.

Detailed description: Longitudinal study of circulating and intra-hepatic HBV-specific T-cell immunity in the setting of a randomised, controlled, international, multi-centre outpatient trial. The trial will randomise HIV/HBV co-infected individuals to different HBV-active antiretroviral therapy treatment regimens.

Study population: Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have detectable HBV viremia and are willing to start antiretroviral therapy.

Eligibility criteria: Inclusion Criteria:

* HIV positive
* hepatitis-B co-infected
* HBV/HIV therapy naive
* \>18 years of age

Exclusion Criteria:

Unable to sign consent form.

Primary outcomes:
measure: To characterize circulating and intra-hepatic anti-HBV T-cell responses longitudinally in HIV-1/HBV co-infected individuals, following effective anti-HBV therapy
timeFrame: 48 weeks
Secondary outcomes:
measure: To identify novel CD4 and CD8 T cell HBV epitopes associated with HBV clearance.
timeFrame: 48 weeks
measure: To identify emergence of cytotoxic T lymphocyte (CTL) "escape" mutants following anti-HBV therapy
timeFrame: 48 weeks
measure: To determine the effect of HIV-1 co-infection and anti-HBV T-cell responses on clearance of free virions and HBV reservoirs using viral dynamic parameters and direct quantification of HBV hepatic reservoirs
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIV-NAT
Study officials:
affiliation: HIV-NAT, The Thai Red Cross AIDS Research Centre
name: Kiat Ruxrungtham, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01611623: Safety and Pharmacology Study of SNX-5422 in Subjects With Refractory Solid Tumor Malignancies
Official title: A Phase 1, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of SNX-5422 in Subjects With Refractory Solid Tumor Malignancies or Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Solid tumor malignancy
Hsp90
Lead sponsor: Esanex Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-05
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: TREATMENT

Brief summary: Hsp90 is a chemical in the body that is involved in promotion of cancer. SNX-5422 is an experimental drug that blocks Hsp90. It is being evaluated for safety in patients with cancer.

Detailed description: Correlation has been observed between Hsp90 client protein level changes and functional effects in cells in in vitro studies of SNX-5422, supporting inhibition of Hsp90 as the mechanism of action for this compound. SNX-5422 has demonstrated significant antitumor activity in mouse xenograft models of human tumors, including breast (BT474, MX-1), colon (HT29), prostate (PC3), and melanoma (A375) with multiple oral dosing regimens. This study will employ critical risk management features including the use of the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, which provides a scale for consistently grading the severity of AEs, toxicity criteria analyses for dose escalation, frequent laboratory and clinical observations, correlation of AEs with plasma concentrations of drug, monitoring of the QTc interval at appropriate time points, and a conservative dose-escalation scheme.

Eligibility criteria: Inclusion Criteria:

* \>18 years old histologically confirmed solid tumor malignancy refractory to available therapy or for which no therapy is available adequate organ function

Exclusion Criteria:

* CNS malignancy significant GI disease at risk for prolonged QT interval

Primary outcomes:
measure: Number of patients with dose limiting toxicities
timeFrame: First 28 day cycle
Secondary outcomes:
measure: Pharmacokinetic profiles of parent drug and metabolite
timeFrame: Day 1 and Day 21 first cycle
measure: Number of patients with adverse events as a measure of tolerability
timeFrame: Day 28 of each cycle
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04703023: Comparison of Water Sorption Capacity and the Composition of Bronchial Fluids of Healthy Persons and Patients With Chronic Obstructive Bronchitis (COPD)
Official title: Vergleich Der Wasseraufnahmefähigkeit Und Zusammensetzung Von Bronchialflüssigkeiten Von Gesunden Und Patienten Mit Chronisch Obstruktiver Bronchitis (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Healthy
Keywords: mucociliary clearance
mucus
sorption of water
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 31
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 who are hospitalized in the Kliniken Essen Mitte

Brief summary: Pilot basic research study on the properties of bronchial mucus. Examination of the sorption and desorption properties, mucin concentration, and structure of the mucus from healthy airways compared to patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description: Mucus, of the correct composition, maintains airway hydration and protects the airway from inhaled particles through mucociliary transport. In chronic inflammatory airway diseases such as COPD or cystic fibrosis, infectious agents, inflammatory cells and products of inflammation such as DNA, increase mucus viscosity which results in decreased mucociliary clearance of inhaled particles, increasing the likelihood of respiratory infections. This pilot study is planned as basic research on the properties of bronchial mucus.

Water isotherms and efficient water activity (sorption and desorption) of the collected samples are examined in defined temperature and humidity settings using DVS Intrinsic (Dynamic Vapour Sorption System, Surface Measurement Systems, London, UK). Findings will provide insights into possible treatment programs targeted at altering specific mucus components.

Eligibility criteria: Inclusion Criteria:

* Age\>18
* COPD or other disease requiring bronchoscopy or elective surgery
* Signed informed consent form

Exclusion Criteria:

* Not able to consent
* Linguistic, cognitive, or other obstacles

Primary outcomes:
measure: Sorption
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
state: NRW
Study officials:
References:
Clinical trial NCT05215223: Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome
Official title: Effect of Whole Body Vibration on Insulin Resistance in Females With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovarian Syndrome
Insulin Resistance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 46
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of whole body vibration on insulin resistance in females with polycystic ovarian syndrome

Detailed description: polycystic ovarian syndrome is a complex endocrine condition characterized by metabolic abnormalities such as insulin resistance, excess weight or obesity, diabetes, and an increased risk of cardiovascular disease.Despite previous studies reported that physical exercise improves insulin resistance in females with polycystic ovarian syndrome, there is no study yet investigate the effect of whole body vibration on insulin resistance

Eligibility criteria: Inclusion Criteria:

1. Females with polycystic ovarian syndrome.
2. Their ages will range from 20 to 35 years.

Exclusion Criteria:

* 1-Smoking. 2-History of chronic disease.

Primary outcomes:
measure: Homeostasis Model Assessment (HOMA-IR)
timeFrame: eight weeks
Secondary outcomes:
measure: Waist circumference
timeFrame: eight weeks
measure: waist hip ratio
timeFrame: eight weeks
measure: LH/FSH ratio
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
affiliation: faculty of physical therapy
name: Mai M Ali Shehata, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02200523: Self Abrading Rapidly Applied Electrode Validation
Official title: Self Abrading Rapidly Applied (SARA) Electrode Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)
Keywords: EEG
electrode
Lead sponsor: Cleveland Medical Devices Inc
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2014-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining multiple steps that burden conventional EEG procedures into one. The investigators believe that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20 minutes) with additional time savings on cleanup. Reducing the hookup time required for the EEG recording will make EEG more feasible in time critical situations and will improve patient care and service. The clinical testing in Phase II will investigate patient acceptance, clinician acceptance, time savings, and signal quality for 3 different environments: the large hospital institution, a small rural hospital setting and in an emergency department.

Detailed description: The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining multiple steps that burden conventional EEG procedures into one. This proposed single-use electrode will consist of a Snap Top, Ag/AgCl Snap Conductor, Conductive Adhesive, and Abrader Tines in a custom molded housing and packed on a backing sheet. After removing the backing, the technician simply parts the hair with one hand and with the other hand rubs the electrode back and forth and then presses the electrode into position on the scalp. The proposed system combines the cumbersome and time-consuming skin preparation, electrode preparation and electrode fixation into one easy step. The investigators believe that the proposed system will reduce patient hookup time by more than 50% (from 40 to 20 minutes) with additional time savings on cleanup. Reducing the hookup time required for the EEG recording will make EEG more feasible in time critical situations and will improve patient care and service.

Eligibility criteria: Inclusion Criteria:

* adult and teenage

Exclusion Criteria:

* young children
* damaged scalp skin
* sensitive or allergic to electrode paste

Primary outcomes:
measure: Signal Quality Comparison Between SARA Electrode and Gold Cup Electrode
timeFrame: up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Research Institute
state: Ohio
Study officials:
affiliation: Great Lakes NeuroTechnologies Inc.
name: Sarah Weimer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06430723: The Impact of Obesity on Short Stem Total Hip Arthroplasty
Official title: Obesity and it's Impact on Subsidence and Clinical Outcomes After Short Stem Total Hip
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: THA
Obesity
Keywords: subsidence
obesity
short stem total hip arthroplasty
tha
Lead sponsor: Krankenhaus Barmherzige Schwestern Linz
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The purpose of this study was to assess the subsidence rates in patients who underwent short stem hip arthroplasty and its association with obesity. To investigate this, an analysis of patient data was conducted together with a follow-up examination, focusing on clinical outcome and radiographic analysis of the subsidence of the stem in obese patients. Hence, two groups based on body mass index were retrospectively evaluated: obese (BMI ≥ 30 kg/m\^2) and non-obese (BMI \< 30 kg/m\^2), with an age of minimum 18 years, but no maximum age.

Brief summary: The purpose of this study is to review the impact of obesity on subsidence and clinical outcome after short stem total hip arthroplasty.

Detailed description: Short stem total hip arthroplasty (THA) has gained popularity due to its bone-sparing technique, but its outcomes in obese patients remain uncertain.

While studies on the mid-term outcome in a general patient cohort provide excellent results in terms of the clinical and radiological outcome as well as the complication rate of short stem THA, data on its use in obese patients is still rare and not sufficiently conclusive. Some studies have found no evidence of increased subsidence in obese patients, while other studies have shown contrary trends.

In this context, the aim of this study was to investigate the relationship between BMI, postoperative subsidence and clinical outcomes in the setting of short stem THA.

Eligibility criteria: Inclusion Criteria:

1. patients who underwent primary short stem hip arthroplasty with Mathys Optimys short stem between 01.01.2018 and 31.12.2020
2. availability of preoperative and postoperative radiographs for assessment of subsidence
3. a minimum BMI of 30kg/m2 for the obese group
4. a minimum follow-up of 24 months.

Exclusion Criteria:

1. former surgeries of the hip in question
2. incomplete clinical data
3. incomplete radiological data

Primary outcomes:
measure: Subsidence
timeFrame: 2 years
measure: Harris Hip Score
timeFrame: 2 years
Secondary outcomes:
measure: surgery time
timeFrame: 2 years
measure: Length of stay
timeFrame: 2 years
measure: Blood loss
timeFrame: 2 years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie
Study officials:
References: