louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04208269: A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3
Official title: A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus
Keywords: preventative
postcard
vaccinate
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 5663
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our project will assess the feasibility and estimate preliminary efficacy of a multilevel intervention to improve HPV vaccine series initiation among adolescents in Medicaid and CHIP. The investigators will use two intervention components: postcards and an iPad survey system. To estimate efficacy the investigators will select potential participants from Florida Medicaid and CHIP. The investigators will assess their claims for the HPV vaccine before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* Enrolled in Florida Medicaid
* Not initiated the HPV vaccine series at the start of the study period.

Exclusion Criteria:

* Anyone who has a severe (life threatening) allergy to any component of HPV vaccine, esp yeast
* Pregnant
* Not enrolled in Florida Medicaid

Primary outcomes:
measure: The number of participants receiving HPV vaccine
timeFrame: Up to 5 months
measure: Number of preventive care visits
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Stephanie Staras, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Staras SAS, Vadaparampil ST, Thompson LA, Scherr C, Gurka MJ, Filipp SL, Shenkman EA. Postcard reminders for HPV vaccination mainly primed parents for providers' recommendations. Prev Med Rep. 2020 Aug 26;20:101188. doi: 10.1016/j.pmedr.2020.101188. eCollection 2020 Dec.
Clinical trial NCT06778369: Triangular Exclusion Technique in Isolated Posterior Mitral Valve Leaflet Prolapse for Mitral Valve Repair
Official title: Triangular Exclusion Technique in Isolated Posterior Mitral Valve Leaflet Prolapse for Mitral Valve Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Posterior Leaflet Prolapse
Keywords: Mitral valve repair;Triangular Exclusion Technique
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-01-16
Enrollment: 58
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if surgical method done to repair one of the heart valve called mitral valve disease during open heart surgery

The main questions aims to answer is:

Does this method is safe and effective for long time and can be used in special cases of mitral valve surgery ? participants come to clinic to be checked clinically and radiologcally every month by the surgeon till 12 month

Detailed description: the surgical method isThe prolapsed part of the posterior leaflet of the mitral valve is inverted and excluded, toward the left ventricle but not cutted echocardiography done before participants leave hospital after sugery, after 6 month and after 12 months to confirm that this method of repair is safe and effective for participants life long

Eligibility criteria: Inclusion Criteria:

* varying degrees of degenerative MV regurgitation, ranging from moderate to severe or severe caused by isolated prolapse of the posterior MV leaflet
* concomitant tricuspid annuloplasty

Exclusion Criteria:

* with Mitral Valve stenosis or any other manifestation of mitral regurgitation pathology.
* individuals requiring surgical intervention for the aortic or pulmonary valves

Primary outcomes:
measure: degree of postoperative mitral valve regurgitation following Triangular Exclusion Technique
timeFrame: about 13 months From enrolment to the end of surgical procedure about one month follow up Echo done after 6 and 12 months so total time frame about 13 months duration
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt
state: El Sharkia
Study officials:
affiliation: cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt
name: sameh saeed, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01621269: ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon
Official title: A 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Fingolimod in the Treatment of Relapsing-remitting Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
MS
Fingolimod
Gilenya
Neutralizing Antibodies
NAb
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-06-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18-65 years
* Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria
* Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5
* Interferon-beta (IFN-β) treatment for at least 18 months.
* Positive IFN-NAb titer at screening or within 6 months prior to screening
* Patients with disease activity despite treatment with IFN-ß measured by gadolinium-enhancing lesions on T1-weighted images on MRI using a triple-dose gadolinium protocol and/or new or newly enlarging T2 lesions (T2 lesions: compared to a reference MRI performed within the last 18 months)

Exclusion Criteria:

* patients with previous or current disease of immune system
* active infections
* cardiovascular risk patients
* Patients unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of patients with active MRI lesions
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02897869: DDI Study to Investigate Interaction Between Amikacin and POL7080
Official title: A Single-center, Open-label, Two Sequence, Crossover Study to Investigate the Interaction Between Amikacin and POL7080 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Polyphor Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study. Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects. The study consists of an eligibility screening period, up to 3 treatments periods and a follow-up visit.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female (of non-childbearing potential) subjects between 18 to 55 years of age (inclusive)
* BMI between 18.0-30.0 kg/m2
* Creatinine clearance estimated by Cockroft Gault formula \> 80 mL/min and \< 160 ml/min (for males), or \< 150ml/min (females)
* Non smokers
* Normal audiogram.

Exclusion Criteria:

* History or suspicion of alcohol and/or drug abuse in the last 5 years
* Within 2 months prior to screening: exposure to aminoglycoside antibiotic, chemotherapy, or current use of loop diuretics
* Regular consumption of large amounts of xanthine
* Any medication that inhibits active tubular secretion within 4 weeks prior to first dosing
* Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
* Any signs of renal impairment
* Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
* Clinically significant abnormal ECG

Primary outcomes:
measure: Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate): Peak Plasma Concentration (Cmax)
timeFrame: Up to 4 days for each period
measure: Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate):Area under the plasma concentration versus time curve (AUC)
timeFrame: Up to 4 days for each period
Secondary outcomes:
measure: Incidence of adverse Events
timeFrame: up to 19 days
Other outcomes:
Locations:
city: Mönchengladbach
country: Germany
Study officials:
References:
Clinical trial NCT03473769: Sepsis Pre-Alert Monitoring Intervention: Study to Investigate Targeted Enhanced Monitoring for Sepsis
Official title: Sepsis Pre-Alert Monitoring Intervention: A Phase I Randomized, Single Blind Study to Investigate Targeted Enhanced Monitoring for Sepsis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sepsis
Keywords: Hospital Admission
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Sepsis is a leading cause of death worldwide, and contributes to approximately 750,000 hospitalizations per year, a third of which may die. International guidelines recommend timely interventions, including cultures, fluid resuscitation and antibiotics. Following guideline bundles is associated with a decrease in mortality. Key to timely intervention is timely diagnosis.

Using the Epic sepsis predictive analytic tool, investigators will trigger vital sign and delirium monitoring in patients determined to be at increased risk for developing future sepsis.

The primary objective of this study is to demonstrate reduced mortality in patients for whom the pre-sepsis algorithm threshold is met, and who enhanced monitoring.

Detailed description: A means to identify patients before they become ill may improve the effectiveness of established therapies.Epic's electronic medical record (Epic systems, Verona, WI) contains a surveillance tool that uses predictive analytics to identify patients at risk of becoming septic four hours after the alert becomes active. This affords the opportunity to intervene sooner, but it remains unclear what the best course of action should be in a population at risk of sepsis, only some of which may go on to develop the illness. We propose an automatic intervention, consisting of enhanced monitoring, that is tied to the alert. No therapeutics will be mandated. Instead, additional monitoring information will lead to faster diagnosis and therapy, and improved clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* any inpatient at NYU Langone Health System

Exclusion Criteria:

* not an inpatient at NYU Langone Health System

Primary outcomes:
measure: Number of in-hospital mortalities
timeFrame: 36 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Mark Nunnally, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02752269: Early Detection of Pulmonary- and Pulmonary Vascular Disease in Sjögren Syndrome
Official title: Early Detection of Pulmonary- and Pulmonary Vascular Disease in Patients Suffering From Sjögren Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sjögren Syndrome
Pulmonary Hypertension
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primary or secondary Sjögren Syndrome.

Brief summary: According to the literature available pulmonary hypertension is present in 12 to 23% of patients suffering from Sjögren Syndrome. However epidemiological data are based on non-invasive measurements using echocardiography. Furthermore, no data are available regarding exercise hemodynamics in those patients.

This study investigates pulmonary hemodynamics at rest and during exercise in patients suffering from primary and secondary Sjögren Syndrome. Patients under suspicion for pulmonary hypertension (PH) will be offered further investigations including right heart catheterization.

Detailed description: Patients with primary and secondary Sjögren Syndrome will be investigated using echocardiography, exercise echocardiography, pulmonary function testing, laboratory testing, electrocardiogram and 6 minute walking test. Those patients under clinical suspicion for pulmonary hypertension will be offered further investigations including right heart catheterization to rule out or verify the diagnosis of manifest pulmonary hypertension.

Eligibility criteria: Inclusion Criteria:

* informed Consent
* diagnosis of Sjögren Syndrome
* age: 18 - 90 yrs

Exclusion Criteria:

* uncontrolled systemic hypertension (at rest \>150 mmHg systolic or 95 mmHg diastolic)
* relevant systolic (EF\<50%) or diastolic (\>Grade 1) left ventricular dysfunction
* uncontrolled ventricular arrhythmias
* uncontrolled supraventricular bradycardia or tachycardia
* myocardial infarction within the last 12 months
* pulmonary embolism within the last 6 months
* larger surgical interventions within the last 12 months
* musculoskeletal or vascular disease, that may affect ergometric investigations
* pregnancy (anamnesis)

Primary outcomes:
measure: prevalence of pulmonary hypertension in Sjögren syndrome
timeFrame: 2 hours
Secondary outcomes:
measure: forced vital capacity
timeFrame: 2 hours
measure: systolic pulmonary arterial pressure at 50 Watts
timeFrame: 2 hours
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: MUG
name: Horst Olschewski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01083069: Follow up After Survived Therapy With Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation (ROSC)
Official title: Neurological Outcome After Mild Induced Hypothermia (MIH) After Restoration of Spontaneous Circulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Hypothermia
Keywords: Sudden cardiac arrest
hypothermia
neurological outcome
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after restoration of spontaneous circulation

Brief summary: Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the long term neurological outcome after mild hypothermia after restoration of spontaneous circulation.

Detailed description: Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC).

Eligibility criteria: Inclusion Criteria:

* survived cardiac arrest
* voluntary consent

Exclusion Criteria:

* no voluntary consent

Primary outcomes:
measure: Neurological outcome after 6 month after MIH, Quality of life-survey
timeFrame: 6 Month
Secondary outcomes:
measure: Managing daily activities
timeFrame: 6 Month
measure: Surviving after hospitalization
timeFrame: 6 Month
measure: Neurological outcome depending of the beginning of MIH
timeFrame: 6 month
measure: Neurological Outcome in consideration of the practice of the treating instances.
timeFrame: 6 month
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig, Heart Center, Cardiology
Study officials:
affiliation: Study Chair
name: Holger Thiele, Associate Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Sub-invesigator
name: Undine Pittl, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03575169: The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury
Official title: The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Bispectral index
Monitoring
Sedation
Traumatic Brain Injury
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Grampian
First posted: 2018-07-02
Enrollment: 26
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 severe traumatic brain injury requiring sedation and mechanical ventilation who are admitted to Aberdeen ICU.

Brief summary: An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.

Detailed description: Patients admitted to Aberdeen ICU with severe traumatic brain injury will have a BIS electrode placed and observed for 24 hours. The study team will be blinded to the result, so not to influence treatment.

All clinical care is at the discretion of the clinical team.

Eligibility criteria: Inclusion Criteria:

* Adults (over 18)
* Diagnosis of traumatic brain injury
* Expected to survive
* Expected to require greater than 24 hours of sedation and mechanical ventilation

Exclusion Criteria:

* Brain injury thought to be unsurvivable by ICU clinical team
* Frontal decompressive craniectomy
* Use of ketamine infusion at recruitment or planned use within 24 hours
* Fractured frontal bone or severe overlying soft tissue injury
* Simple extradural haemorrhage with no other obvious intracranial injury
* Pregnant patient

Primary outcomes:
measure: Mean BIS
timeFrame: 24 hours
Secondary outcomes:
measure: Mean ICP
timeFrame: 24 hours
measure: Incidence of osmotherapy use
timeFrame: 24 hours
measure: Vasopressor dose
timeFrame: 24 hours
measure: Sedative dose
timeFrame: 24 hours
measure: Length of ICU stay
timeFrame: Days to weeks
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Intensive Care Unit, Aberdeen Royal Infirmary
city: Dundee
country: United Kingdom
facility: NHS Tayside
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
References:
Clinical trial NCT00265369: TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children
Official title: Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhea
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-14
Enrollment: 420
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective:

* To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days.

Secondary objective:

* To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.


Eligibility criteria: Inclusion criteria:

Infants or Children

* Non hospitalized infants or children
* With acute diarrhea evident for less than 48 hours
* Having had three or more watery stools during the preceding 24 hours

Exclusion criteria:

Infants or Children

* With blood stools
* Having been treated with antibiotics or probiotics within the two weeks before the enrollment
* Suffering from dehydration defined by a weight loss of at least 5% or by the presence of a skin fold
* With an history of seizures
* With immunosuppressive conditions
* With a current status requiring an antibiotic treatment
* Suffering from a chronic disease including chronic diarrhea whatever the origin
* Having received before inclusion one of the following treatments:

  * Probiotics
  * Prebiotics
  * Drugs with adsorbing properties
  * Drugs that modify intestinal secretion like bismuth subsalicylate, acetorphan
  * Drugs that modify intestinal motility (opiates such as loperamide, atropine and other cholinergic agents).
* Having participated in another clinical trial in the last 3 months prior to the start of the study

Primary outcomes:
measure: Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools
Secondary outcomes:
measure: Number of infants/children with normal stools at D3, D4, D5, D6 and D7;Mean number of stools per day;Occurrence of vomiting episodes per day after enrolment;Parents'overall global assessment of efficacy at the end of the treatment;other safety criteria
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Sanofi-Aventis
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Gilles Perdriset, MD
role: STUDY_DIRECTOR
References: