louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05596162: The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains
Official title: The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ankle Sprain 1St Degree
Ankle Sprain 2Nd Degree
Musculoskeletal Injury
Keywords: blood flow restriction
ankle sprain
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 0
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 primary objective of this study is to evaluate the feasibility of implementing BFR in the rehabilitation treatment of isolated ankle sprains as well as to evaluate the clinical benefits of BFR when compared to standard treatment. This study will evaluate the efficacy of using BFR therapy for the treatment of acute grade I and II ankle sprains. The investigators will evaluate clinical outcomes of range of motion (ROM) and strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion.

This will be a small, randomized control trial study. The investigators will enroll a total of 40 participants, 20 participants will undergo standard physical therapy for isolated lateral ankle sprains and 20 participants will undergo BFR therapy for an isolated lateral ankle sprain. Patients will be randomized into control and experimental group via block randomization.


Eligibility criteria: Inclusion Criteria:

* Patients will include English speaking student athletes aged 18 and older with clinical diagnosis of an isolated grade I or II lateral ankle sprain

Exclusion Criteria:

* History of DVT/PE, clotting disordered, peripheral arterial disease, hypertension (BP\>140/90), coronary artery disease, or pregnancy

Primary outcomes:
measure: Time to Return to Play
timeFrame: From Time of Injury to 8 weeks after Injury
Secondary outcomes:
measure: Pain Level
timeFrame: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
measure: Range of Motion
timeFrame: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
measure: Strength Testing
timeFrame: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
measure: The Foot and Ankle Ability Measure (FAAM) Patient-Reported Score
timeFrame: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
measure: Foot and Ankle Outcome Score (FAOS) Patient-Reported Score
timeFrame: Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Other outcomes:
Locations:
city: Nashville
country: United States
facility: VUMC
state: Tennessee
Study officials:
References:
Clinical trial NCT01848262: ECALMIST Versus InSurE in Preterm Infant < 32 Weeks,Multicenter, Multinational RCT
Official title: ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant Therapy) Versus InSurE (Intubate, Surfactant, Extubate) in Preterm Infants With Respiratory Distress Syndrome (RDS): Prospective Randomised Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: ECALMIST
InSurE
CPAP
Ventilation
Vascular Catheter
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 24
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Minimally invasive surfactant therapy via a small vascular catheter - ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant Therapy) versus InSurE (Intubate, Surfactant Extubate) in preterm infants with Respiratory Distress Syndrome (RDS): A prospective randomized clinical trial.

Detailed description: After meeting all the inclusion criteria, eligible infants will be randomized to receive surfactant either through the ECALMIST or the InSurE methods. The attending neonatologist or neonatal team will have full discretion to decide when to intubate and when to extubate or wean the infant off the ventilator or NCPAP.

General guidelines for reintubation include persistent pH\<7.20, PaCO2 \> 65 mmHg, very frequent apnea (\>2-3/hour of apneic or bradycardic spells not responsive to corrective therapy), frequent desaturations \>3/hour not responding to increase in FiO2 or increase in FiO2 to 100%), or apneas requiring prolonged PPV. For the purpose of the study a successful outcome for the primary objective will have occurred if the infant has not been reintubated and ventilated during the initial 3 days of life.

Eligibility criteria: Inclusion Criteria:

All should apply:

* Newborn less than 32 weeks gestation at birth
* Postnatal age \< 24 hrs of life
* Clinical diagnosis of RDS
* Spontaneously breathing on NCPAP
* Clinical decision to give surfactant.

Exclusion Criteria:

* Lack of parental consent.
* Need for mechanical ventilation
* Major congenital malformation

Primary outcomes:
measure: Incidence of early ventilation hours
timeFrame: 3 days
Secondary outcomes:
measure: Apnea
timeFrame: 15 minutes
measure: Bradycardia
timeFrame: 15 minutes
measure: Desaturation
timeFrame: 15 minutes
measure: Total ventilation hours
timeFrame: hospital admition days
measure: Incidence of Chronic lung disease
timeFrame: 1st 2 months of life
measure: Early ventilation hours
timeFrame: 3 days
Other outcomes:
measure: Hospital stay
timeFrame: 1st three months of life
Locations:
city: Winnipeg
country: Canada
facility: Health sciences Center
state: Manitoba
city: Winnipeg
country: Canada
facility: St Boniface Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Yahya Ethawi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03915262: Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease
Official title: Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn Disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an active Crohn's Disease

Brief summary: This study aims to assess the prevalence of exocrine pancreatic insufficiency (EPI) in a population of patients with active Crohn's disease. Studies already describe a prevalence rate around 18-66%. In this multicentric prospective study, we plan to compare EPI's prevalence at week 0 and week 14 of an induction phase of a biological therapy. The biological therapy will be initiate for an active Crohn's disease. Secondary outcomes will be: malnutrition's prevalence, and Crohn's disease activity level.


Eligibility criteria: Inclusion Criteria:

* Age of 18 years or more
* Crohn's disease diagnosed for more than 3 months.
* Active Crohn's disease : CDAI score \> 150 + \[CRP \> 5 mg/L or faecal calprotectin \> 250mcg/g or endoscopic lesion or MRI lesion\]
* Indication of a biological therapy (anti-TNFα, vedolizumab ou ustekinumab).

Exclusion Criteria:

* Crohn's disease that doesn't fit the previous criteria
* Extended resection of small intestine (\>40cm)
* Chronic pancreatitis diagnosed before inclusion
* Contraindication to biological therapy (anti-TNFα, vedolizumab ou ustekinumab)
* Pancreatic enzyme replacement therapy
* Pregnant or breastfeeding woman
* Patient under the protection of a conservator

Primary outcomes:
measure: Exocrine pancreatic insufficiency's prevalence
timeFrame: week 0
measure: Exocrine pancreatic insufficiency's prevalence
timeFrame: week 14
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre Benite
country: France
facility: Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL
Study officials:
affiliation: Hospices Civils de Lyon
name: Gilles BOSCHETTI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01306162: Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects
Official title: Relative Bioavailability of a Single Dose of 150 mg Dabigatran Etexilate (Capsule) When Administered Alone or in Combination With a Single Dose of 400 mg Dronedarone Tablet) or in Combination With 400 mg Bid Dronedarone (Tablet) at Steady State in Healthy Male and Female Volunteers (an Open Label, Randomised, Four-sequence, Two Period Cross-over, Phase I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-03-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the relative bioavailability of a single dose of dabigatran after concomitant multiple oral administration of dronedarone with the aim to investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic parameters of dabigatran when administered to healthy subjects


Eligibility criteria: Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Total Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)
timeFrame: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration
measure: Total Dabigatran: Maximum Measured Concentration (Cmax)
timeFrame: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration
Secondary outcomes:
measure: Free Dabigatran: Area Under the Curve 0 to Infinity (AUC0-∞)
timeFrame: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration
measure: Free Dabigatran: Maximum Measured Concentration (Cmax)
timeFrame: 1 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: 1160.112.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01455662: Relationship Between Tissue Markes in Patients With Post Cardio Respiratory Syndrome
Official title: Relationship Between Lactate and Venous Oxygen Saturation Gradient of Carbon Dioxide in Patients With Post Cardio Respiratory Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Keywords: cardiac arrest
Lead sponsor: Hospital Nossa Senhora da Conceicao
Sponsor class: OTHER
First posted: 2011-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients hospitalized in the intensive care unit after cardiopulmonary arrest

Brief summary: There is a correlation between hospital mortality and changes in markers of tissue perfusion, lactate, and venous oxygen saturation and carbon dioxide gradient.

Detailed description: Evaluation of the serum carbon dioxide gradient (GapCO2), central venous saturation (ScvO2) and the clearance of serum lactate (Clac) in predicting hospital mortality after cardiac arrest syndrome (post-PCR).

Prospective study, unicenter - Intensive Care Unit - HNSC. Period: May/2010 to June/2011. Serial assessment of GapCO2 of ScvO2 Clac and the first 72 hours post-PCR. Excluded under 18, survival of less than 6HS, pregnant women, traumatized, post-operative hypothermia and liver disease. T-student test, 95% (p \<0.05).

Eligibility criteria: Inclusion Criteria:

* All patients hospitalized in the intensive care unit after cardiopulmonary arrest with any pace

Exclusion Criteria:

pregnant women, traumatized, post-operative(less 7 days), hypothermia and liver disease.

* patients hospitalized in the intensive care unit with more than 6 hours post cardiac arrest
* less 18 years old

Primary outcomes:
measure: mortality
timeFrame: 1 year
Secondary outcomes:
measure: correlation of clearance markers of perfusion with the use of vasopressor and positive fluid balance
timeFrame: 6 hours
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Conceição Hospital
state: Rio Grande do Sul
Study officials:
affiliation: Conceição Hospital
name: Vanessa Oliveira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Nossa Senhora da Conceição
name: Diego F Riveiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02572362: Secondary Cancer Risk After Radiation Therapy for Rectal Cancer
Official title: Estimation of Second Cancer Risk in Patients Planned With Different Radiotherapy Regimes for Rectal Cancer - A Planning Study and Model-based Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms, Second Primary
Lead sponsor: Kantonsspital Graubuenden
Sponsor class: OTHER
Collaborators: name: Klinik Hirslanden, Zurich
First posted: 2015-10-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having had radiation therapy for rectal cancer. Estimation of second cancer risk using data from planning CTs comparing dose Distribution using different Radiation therapy techniques (3DCRT vs VMAT).

Brief summary: Retrospective study comparing dose distribution of 3D conformal radiotherapy (3DCRT) and volumetric-modulated arc therapy (VMAT) to estimate secondary cancer risk for patients having had radiation therapy for rectal cancer. Twenty-five patients are included in this study. Planning CT scans are used for comparison of dose distribution and calculation of second cancer risk.

Detailed description: A model-based Analysis calculating the organ-specific excess lifetime attributable risk using the planning CT data sets of 25 patients to estimate second cancer risk for patients after radiotherapy for rectal cancer comparing conventional 3DCRT with VAMT techniques.

Eligibility criteria: Inclusion Criteria:

* Male/Female \> 18 years of age
* pre or postoperative radiation therapy for rectal cancer
* Planning CT

Exclusion Criteria:

* Planning CT not available

Primary outcomes:
measure: Calculation of the organ-specific excess lifetime attributable risk (LAR) (%)
timeFrame: 60 years (model-based calculation)
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Klinik Hirslanden, Institute for Radiotherapy
Study officials:
affiliation: Kantonsspital Graubuenden
name: Daniel R Zwahlen, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zwahlen DR, Bischoff LI, Gruber G, Sumila M, Schneider U. Estimation of second cancer risk after radiotherapy for rectal cancer: comparison of 3D conformal radiotherapy and volumetric modulated arc therapy using different high dose fractionation schemes. Radiat Oncol. 2016 Nov 10;11(1):149. doi: 10.1186/s13014-016-0723-6.
Clinical trial NCT04180462: Increasing Optimal Use of HPV Vaccination in Primary Care
Official title: Randomized Controlled Trial to Evaluate an Implementation Strategy to Increase Optimal Use of HPV Vaccine in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus Vaccines
Keywords: Implementation Strategy
Quality Improvement
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-11-27
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Washington University will evaluate the effectiveness of a multi-component implementation strategy to increase use of HPV vaccine in primary care practices.

Detailed description: The investigators at Washington University will complete a cluster-randomized trial to evaluate the effectiveness of a multi-component implementation strategy (the intervention) to increase use of the HPV vaccine according to CDC guidelines. The unit of randomization is a community-based, primary care pediatric practice. Twenty practices will be randomized into two groups, the intervention group (n=10) or a wait-list control group (n=10). The intervention will be implemented over 2-years and includes: 1) an educational video for providers; 2) audit and feedback of vaccine coverage; 3) a communication strategy; and 4) practice facilitation.

The primary outcome of HPV vaccination by age 13 will be assessed at 24 months, and at 36 months to assess if change is sustained.

Eligibility criteria: Inclusion Criteria

Practices:

* Community-based pediatric primary care practices with 2 or more providers.
* Providers who deliver wellness care to preteens and adolescents.
* Willingness to participate in the practice facilitator-guided QI process.

Providers:

* Providers who deliver wellness care to preteens and adolescents.
* Willingness to complete study questionnaires.
* Willingness to participate in the practice facilitator-guided QI process.

EXCLUSION CRITERIA

* Practices and providers may be excluded at the discretion of the PI.

Primary outcomes:
measure: Initiation of the HPV Vaccine 2-dose Series.
timeFrame: 24 months
measure: Completion of the HPV Vaccine 2-dose Series.
timeFrame: 24 months
Secondary outcomes:
measure: Sustainability of the Intervention Benefit for Initiation of the HPV Vaccine.
timeFrame: 36 months
measure: Sustainability of the Intervention Benefit for Completion of the HPV Vaccine.
timeFrame: 36 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Allison King, M.D., Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02394262: Sequential Coronary CT-angiography and Biomarkers
Official title: Prediction of Atherosclerotic Plaque Burden Progression With Sequential Coronary CT-angiography and Biomarkers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Atherosclerosis
Keywords: Biological Markers
Multidetector Computed Tomography
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-03-20
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Currently, cardiac computed tomography angiography (CCTA) is a well-implemented non-invasive diagnostic imaging modality in patients with stable chest pain. Besides conventional CT-reading, CCTA is also capable to identify several morphologic and geometric characteristics of atherosclerotic plaques. Recently, the investigators showed that the use of semi-automated plaque quantification algorithm identified parameters predictive for acute coronary syndrome on top of clinical risk profiling and conventional CT-reading. In addition, several atherotrombosis biomarkers, like high-sensitivity cardiac troponins, are described as related to coronary artery disease and cardiovascular events. Prospective data with sequential analysis of atherosclerotic plaques combined with different atherothrombosis biomarkers are currently lacking, but will provide important clues about the pathophysiology of plaque progression and atherothrombosis.


Eligibility criteria: Inclusion Criteria:

* Patients with a recent history of (a)typical chest pain, who underwent a coronary calcium score scan as well as CCTA.
* Age older than 18 years and competent to perform written informed consent.
* At least 2 coronary segments with plaques:
* 1 proximal lesion.
* At least one coronary plaque consisting of a non-calcified or mixed component.

Exclusion Criteria:

* Unstable angina.
* Renal insufficiency: calculated estimated glomerular filtration rate \<45mL/min.
* Iodine allergy.
* Pregnancy.
* Known history of atrial fibrillation.
* Inconclusive baseline computed coronary CT-angiography.
* Patients which are currently on oral vitamin K antagonists.
* Patients which are currently using selective anticoagulants.
* Previous PCI.
* Previous or planned coronary artery bypass grafting.
* Patients whereby the baseline CCTA was performed by a retrospective ECG-gated 'helical' protocol due to a high (\>90bpm) or irregular heart rate.

Primary outcomes:
measure: Plaque progression as defined by sequential CCTA using dedicated software.
timeFrame: 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Bas Kietselaer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00205062: Positron Emission Tomography (PET)-Computed Tomography (CT) in Inflammatory Bowel Disease (IBD)
Official title: Pilot Study of the Role of PET-CT for Diagnosis and Assessment of Therapeutic Efficacy in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Inflammatory Bowel Diseases
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main hypothesis is that PET-CT will be a valuable diagnostic tool in diagnosing and evaluating treatment for IBD.


Eligibility criteria: Inclusion Criteria:

* Patient with either Crohn's disease or ulcerative colitis whose disease is flaring

Exclusion Criteria:

* Indeterminate diagnosis, pregnant, breastfeeding, or other contraindication to PET-CT

Primary outcomes:
measure: Does this technique provide an accurate assessment of disease inflammation compared to standard clinical markers?
Secondary outcomes:
measure: Does this technique provide additional information for practitioners on extent of disease?
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Randall Meisner, MD
role: PRINCIPAL_INVESTIGATOR
References: