louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03018548: Improvised Explosive Device (IED) Level Blasting of Human Blood With Slosh Prevention
Official title: Improvised Explosive Device (IED) Level Blasting of Human Blood With Slosh Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To monitor changes in indicators of red cell damage such as extracellular hemoglobin, potassium (K-ABL), and lactate dehydrogenase (LD) post blast exposure.

Detailed description: Traumatic brain injury (TBI) causes significant morbidity and mortality, accompanied by high related costs. Recent hypotheses concerning the pathophysiology of TBI invoke Strain Shear Theory and Cavitation Theory. The invbestigators propose to test the importance of the latter by directing blast waves into containers that are either partially or completely filled with blood and measuring markers of lysis.

These experiments are designed to better understand the demonstrated effectiveness of mild jugular compression according to the principle of the Queckenstedt Maneuver to reduce the likelihood of TBI by filling up the compliance of the cranial space. A device (C-Collar) is being developed by Q30 Labs, LLC (Q30), to accomplish this effect.

Eligibility criteria: Inclusion Criteria:

* • Normal healthy volunteer

  * Able to provide written consent
  * Must be 18 years or older

Exclusion Criteria:

* • Unable to provide written consent

  * Recent penetrating brain trauma (within 6 months)
  * Under the age of 18 years

Primary outcomes:
measure: Lysis of blood cells
timeFrame: within 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Childrens Hospital
name: Gregory D Myer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04595448: Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation
Official title: Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation - An Unknown Collaborator in a System Under Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphatic Insufficiency
Heart Failure
Edema
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with moderate to severe tricuspid regurgitation and healthy, age, gender, and weight-matched controls

Brief summary: The study will examine the lymphatic functional and morphological status in patients with moderate tricuspid valve regurgitation compared to healthy age and gender-matched controls.

The study will use t2 weighted MRI, Near-infrared fluorescence imaging, and plethysmography to examine the above-mentioned question.

Detailed description: The study will examine the lymphatic functional and morphological status in patients with moderate tricuspid valve regurgitation compared to healthy age and gender-matched controls.

Subjects will be examined at one occasion using t2-weighted MRIs to evaluated lymphatic anatomy and Near-infrared fluorescence imaging for evaluation of superficial peripheral lymphatic function. Finally, the capillary filtration rate will be estimated using plethysmography.

Eligibility criteria: Patients:

Inclusion criteria:

* Patients with moderate to severe tricuspid regurgitation
* Age ≥18 years
* Informed consent

Exclusion criteria:

* Reduced ejection fraction (\<50%)
* Congenital heart disease
* Left sided valve disease
* MRI contraindications (All metal implants, cochlear implants, pacemakers etc.)
* Claustrophobia
* Peripheral edema
* BMI\>30
* Age\<18.

Controls:

Inclusion criteria:

* Healthy
* Age ≥18 years
* Age, gender and weight matched with included patients.

Exclusion criteria:

* Cardiovascular disease
* MRI contraindications (All metal implants, cochlear implants, pacemakers etc.)
* Claustrophobia
* Peripheral edema
* BMI\>30
* Age\<18.

Primary outcomes:
measure: Thoracic duct tortuosity (centimeters/centimeters)
timeFrame: 20 minutes
measure: Thoracic duct volume (cubic centimetres)
timeFrame: 30 minutes
measure: Excess fluid (yes/no)
timeFrame: 40 minutes
measure: Peripheral lymphatic velocity (centimeters/second)
timeFrame: 1 hour
measure: Peripheral lymphatic frequency (contractions/minute)
timeFrame: 1 hour 30 minutes
Secondary outcomes:
measure: Capillary filtration
timeFrame: 2 hours
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Cardiothoracic Surgery
state: Central Denmark Region
Study officials:
References:
Clinical trial NCT06596148: Improving Shingrix Vaccination Among US Veterans Receiving Immunosuppression
Official title: VA Quality Improvement Research and Training Initiative
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Immunosuppresion
Keywords: Wait-list control randomized trial
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Veterans Affairs Medical Center
First posted: 2024-09-19
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will use a wait-list control design; clinicians from VA facilities will be randomized to receive access to the dashboard early vs. after a 6-9 month delay. The investigators will compare Shingrix vaccination rates in the two groups of facilities.
Primary purpose: PREVENTION

Brief summary: The goal of this wait-list control trial is to learn if having access to a new dashboard displaying information about immunosuppressed Veterans missing vaccinations for Shingrix can improve Shingrix vaccination rates at VA facilities.

The main question\[s\] it aims to answer is: Will vaccination rates improve more rapidly for facilities with access to the dashboard compare to facilities without access? VA facility personnel will be granted access to the dashboard and outcomes (vaccination rates) will be measured using electronic health record data.

Detailed description: Assignment of the intervention will occur at the facility level. Outcomes (vaccination) will be assessed for patients cared for at each facility.

Eligibility criteria: Inclusion Criteria:

* In order to be included in the study, clinicians need to work at a VHA facility and have access to the electronic health record.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Percentage of patients with at least 1 Shingrix vaccine documented, by facility
timeFrame: From enrollment until end of follow up at 18 months.
Secondary outcomes:
measure: Percentage of patients with at least 2 Shingrix vaccinations documented, by facility
timeFrame: From enrollment until end of follow up at 18 months.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA
state: California
Study officials:
affiliation: San Francisco VA Medical Center
name: Gabriela Schmajuk, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00072748: Study Evaluating EKB-569 in Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Keywords: Advanced Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2003-11-13
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced colorectal cancer. Patients must have been previously treated with a fluoropyrimidine (5-FU or capecitabine) and either oxaliplatin or irinotecan (given concurrently or as separate regimens).

The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced colorectal cancer.

Secondary objectives include:

* To further evaluate the safety of EKB-569
* To explore additional clinical activity parameters
* To explore subject survival
* To evaluate the pharmacokinetics of EKB-569
* To assess subject reported outcomes

EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.


Eligibility criteria: Inclusion Criteria:

* Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures
* Previous histologic diagnosis of adenocarcinoma of the colon or rectum
* EGFR expression by immunohistochemical analysis (must be \> or = 20% positive tumor cells in prior tumor biopsy specimens)

Exclusion Criteria:

* Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas).
* Prior epidermal growth factor receptor-targeting therapy
* Known central nervous system (CNS) metastases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01325948: Cross-sectional Study to Investigate the Effects of Chronic Obstructive Pulmonary Disease on Daily Life Activities
Official title: Cross-sectional Observational Study to Investigate the Effects of Chronic Obstructive Pulmonary Disease on Daily Life Activities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-03-30
Enrollment: 497
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients from health institutions where the patients with COPD are treated

Brief summary: The purpose of this study is to investigate the effects of Chronic Obstructive Pulmonary Disease (COPD) on daily life activities in patients with COPD and also to determine the socio-demographic profile, daily life style and needs of the patients with COPD.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD
* Outpatient treatment for any reason
* Current or ex-smoker

Exclusion Criteria:

* An exacerbation of COPD that still lasts or that was experienced within last 3 months
* History of asthma and/or allergic rhinitis
* The presence of another important respiratory disease

Primary outcomes:
measure: Effect of COPD on daily activities
timeFrame: 1 year
Secondary outcomes:
measure: Patients' socio-demographic profiles, daily life conditions and needs and expectations from therapy
timeFrame: Baseline
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Aydin
country: Turkey
facility: Research Site
city: Bartin
country: Turkey
facility: Research Site
city: Bolu
country: Turkey
facility: Research Site
city: Burdur
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Gaziantep
country: Turkey
facility: Research Site
city: Gebze
country: Turkey
facility: Research Site
city: Giresun
country: Turkey
facility: Research Site
city: Isparta
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Karabuk
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
city: Konya
country: Turkey
facility: Research Site
city: Manisa
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Yozgat
country: Turkey
facility: Research Site
Study officials:
affiliation: AstraZeneca Turkey
name: Zeynep Goztas
role: STUDY_DIRECTOR
affiliation: Adnan Menderes University Faculty of Medicine
name: Mehmet Polatli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01723748: Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects
Official title: Somatostatin Analogue Treatment of Acromegaly: Molecular Aspects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acromegaly
Metabolic Diseases
Keywords: Acromegaly
Somatostatin treatment
metabolic effect
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-11-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough

Hypotheses: Treatment of acromegaly with SA versus surgery alone is associated with:

* Glucose intolerance despite normalized insulin sensitivity
* Modified peripheral GH activity in peripheral target organs assessed on molecular endpoints

Detailed description: Acromegaly is a rare disease usually caused by a benign growth hormone (GH) producing pituitary adenoma. In case of inadequate disease control, the condition is associated with significant morbidity and approximately a doubling of mortality compared to the background population. Medical treatment with somatostatin analogues (SA) has been employed for about 20 years and is a well-established treatment in cases where surgery is impossible or inadequate. The treatment with SA still leaves some questions unanswered. Firstly, SA treatment often results in a concomitant suppression of the insulin secretion, which might lead to clinically significant glucose intolerance. Secondly, the traditional evaluation of disease activity by measuring circulating levels of GH and total IGF-I is not reliable enough

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* treated acromegaly
* considered suitable

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Metabolism - including GH, IGF-I, FFA, glc and insulin. Concentration and AUC (area under the curve)
timeFrame: 3 years
Secondary outcomes:
measure: concentration of serum and interstitial GH, bioactive IGF-I as well as total IGF-I
timeFrame: 3 years
Other outcomes:
measure: GH, and insulin signal transduction in muscle and fat biopsies and regulation of lipolysis.
timeFrame: 3 years
measure: patient characterization
timeFrame: 3 years
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Jens Otto L Joergensen, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02991131: Sivextro in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global Observational Study
Official title: DART: "Sivextro® in Acute Bacterial Skin anD Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global ObseRvational STudy."
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Skin Disease, Infectious
Keywords: Acute bacterial skin infection
Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Abscess
Cellulitis
Erysipelas
Wound infection
Methicillin resistant Staphylococcus aureus (MRSA)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 108
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: Hospitalized patients

Brief summary: This open-label, prospective, multi-center, non-interventional, observational, parallel cohort study intended to provide real life data on the treatment duration, effectiveness and safety of tedizolid and linezolid when treating ABSSSI hospitalized patients in a real practice setting.

Detailed description: The primary objective of this study was to assess the treatment duration in the real life in 2 cohorts consisting of patients treated by 200 mg once daily IV/PO tedizolid or treated by 600 mg twice daily IV/PO (intravenous/per oral) linezolid.

Eligibility criteria: Inclusion Criteria:

* Adult female and male in-patients with clinical diagnosis compatible with ABSSSI (cellulitis/erysipelas, major skin abscess or wound infections) with a clinical suspicion of infection by Gram positive bacteria (with or without laboratory confirmation).
* Patients for whom the decision to initiate treatment with tedizolid phosphate or linezolid was made as per physician's routine treatment practice.
* Signed informed consent.

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice.
* Patients who have been enrolled in this study before.

Primary outcomes:
measure: Number of treatment days
timeFrame: Up to 1 month
Secondary outcomes:
measure: Number of participants with adverse events or safety-relevant changes in laboratory parameters
timeFrame: Up to 1 month
Other outcomes:
measure: Number of participants with investigator-assessed clinical response
timeFrame: Up to 1 month
Locations:
city: Multiple Locations
country: Mexico
city: Multiple Locations
country: Russian Federation
city: Multiple Locations
country: Singapore
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01248182: Bone to Skin Thickness Study: Obese Versus Normal Population
Official title: Bone to Skin Thickness Study: Obese Versus Normal Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fracture
Keywords: acetabular fracture
pelvic ring injury
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2010-11-25
Enrollment: 21
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 pelvic ring injury or acetabular fracture

Brief summary: The purpose of this study is to determine the bone to skin depth for groups of lean, obese and morbidly obese patients. This information will be potentially helpful with implant design for obese and lean patients.

Detailed description: This study will examine pelvic CT scans of injured patients to determine skin thickness in several distinct regions important in orthopedic surgery. All patients admitted to the University of Mississippi Medical Center with a pelvic ring injury or acetabular fracture obtain a pelvic CT scan as a standard part of patient evaluation. The CT scans attempt to encompass the entire soft tissue sleeve from the skin edge to the pelvic bones. Several landmarks described below have been described to measure important surgical sites where obesity is problematical. Therefore this study is an attempt to quantify the size of the soft tissue envelope in patients

However, patients who are markedly obese may be too large for the entire soft tissue sleeve to be imaged with the CT scan. The second part of the study then is to validate the CT scan measurements obtained using clinical measurements. The clinical measurements will be obtained during operative management of displaced pelvic ring injuries and/or acetabular fractures. During surgical exposure, a measuring tape will be used to measure the soft tissue thickness in those areas corresponding to the CT scan measurements. These measures will be compared to validate the effectiveness of CT scan measurements to accurately document the soft tissue dimensions.

Eligibility criteria: Inclusion Criteria:

* Anyone admitted to the University of Mississippi Medical Center with a pelvic ring or acetabular injury

Exclusion Criteria:

* Those not fitting the inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Matthew Graves, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02602782: Physiologic Signals and Signatures With the Accuryn™ Monitoring System in Intensive Care Patients
Official title: Physiologic Signals and Signatures With the Accuryn™ Monitoring System in Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care, Intensive Care
Lead sponsor: Potrero Medical
Sponsor class: INDUSTRY
First posted: 2015-11-11
Enrollment: 76
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: Significantly injured trauma ICU patients receiving a Foley catheter and transfusion

Brief summary: The purpose of the study is to collect physiologic data streams with the Accuryn Monitoring System and validate the accuracy of these measurements against existing gold standards, and to track and analyze changes in these physiologic data streams to identify clinical signatures that may enable earlier diagnosis and intervention of critical conditions.


Eligibility criteria: Inclusion Criteria:

* Admission to the hospital with trauma (including burn)
* Anticipated ICU stay of at least 72 hours
* Anticipated transfusion of ≥1 unit blood products (pRBC's, platelets, and/or plasma) within the first 24 hours of hospitalization, and/or a current diagnosis of sepsis/septic shock, and/or ICU admission primarily for burn
* Anticipated requirement for a urinary bladder catheter for ≥ 72 hours

Exclusion Criteria:

* Inability to receive a 16F urinary bladder catheter
* Significant bladder or urethral injury
* In the opinion of the investigator the patient is unsuitable for the study for any other legitimate reason including incarceration, pre-existing medical or psychiatric condition, or interfering medications
* Known previous or concurrent enrollment in a clinical trial that, in the opinion of the investigator, might interfere with the objectives of this clinical trial
* Pregnancy known at the time of presentation

Primary outcomes:
measure: Comparison of physiologic signals as measured by the Accuryn Monitoring System compared to existing gold standard measurements.
timeFrame: During the ICU stay (approximately 2-4 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: