louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01361087: Circulating Transforming Growth Factor Beta (TGF-β) in Individuals With Marfan Syndrome
Official title: Circulating Transforming Growth Factor Beta (TGF-β) in Individuals With
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Marfan Syndrome
Keywords: TGF-B blood levels Atenolol vs, Losartan Study, NIH, NIHLB and NMF
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2011-05-26
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Transforming Growth Factor Beta (TGF-β) is a protein that controls proliferation, cellular differentiation, and other functions in most cells. TGF-β levels play a major role in the pathogenesis of Marfan syndrome, a disease characterized by disproportionate height, long extremities, lens dislocation in the eyes and heart complications such as mitral valve prolapse and aortic enlargement increasing the likelihood of aortic dissection. While the underlying defect in Marfan syndrome is faulty synthesis of the glycoprotein fibrillin I, normally an important component of elastic fibers it has been shown that the Marfan syndrome phenotype can be relieved by addition of a TGF-β antagonist in affected mice.

Detailed description: Transforming Growth Factor Beta (TGF-β) is a protein that controls proliferation, cellular differentiation, and other functions in most cells. TGF-β levels play a major role in the pathogenesis of Marfan syndrome, a disease characterized by disproportionate height, long extremities, lens dislocation in the eyes and heart complications such as mitral valve prolapse and aortic enlargement increasing the likelihood of aortic dissection. While the underlying defect in Marfan syndrome is faulty synthesis of the glycoprotein fibrillin I, normally an important component of elastic fibers it has been shown that the Marfan syndrome phenotype can be relieved by addition of a TGF-β antagonist in affected mice. This suggest that while the symptoms of Marfan syndrome may seem consistent with a connective tissue disorder, the mechanism is more likely related to reduced sequestration of TGF-β by fibrillin.

Eligibility criteria: Inclusion Criteria:

* Individual with Marfan syndrome consented in to the Main Atenolol Vs. Losartan NIH study.

Exclusion Criteria:

* Subjects in the main PHN Marfan trial who have not achieved the maintenance drug dosing or who have stopped taking study drug.

Primary outcomes:
measure: To determine if circulating levels of TGF-β correlate with treatment arms: Atenolol vs. Losartan.
timeFrame: 1 year
Secondary outcomes:
measure: To determine if circulating levels of TGF-β correlate with clinical outcomes within a treatment group or independent treatment groups.
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's Memorial Hospital Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT03587987: Comparison of Two Different Resuscitation Devices
Official title: Manikin Study of the Comparison of Two Different Resuscitation Devices (Neopuff and rPAP) During Simulated Resuscitation in the Neonatal Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Manual Ventilation
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a complex physiological process involved in establishing regular breaths at birth. After initiation of the first breath, fluid is removed from the alveoli and enough pressure must be generated to inflate the lungs . Most newborns will establish spontaneous regular breathing sufficient to maintain the heart rate above 100 beats/min and to improve perfusion within 3 minutes of birth. According to the neonatal resuscitation programme (NRP), if heart rate is below 100 or there is persistence of apnoea or gasping after the initial steps of drying/stimulation and oropharyngeal suction, intervention is required .

The main focus of neonatal resuscitation is effective ventilation to improve gas exchange and prevent respiratory failure. After birth, approximately 4% to 10% of term and late preterm newborns will receive help breathing with positive-pressure ventilation (PPV). Adequate mask ventilation is essential when providing breaths during neonatal resuscitation. However, this can be difficult, especially for less experienced staff and may be affected by inadequate seal of the mask, gas leaks and airway obstruction. In addition, trauma may be caused by the volumes being given during pressure controlled ventilation.

Detailed description: Comparison of two different neonatal resuscitation devices (Neopuff and rPAP) in the Neonatal Unit in Cork University Maternity Hospital. Participants will use the devices on a mannequin. Performance of the two devices is judged by comparing the tidal volumes produced.

Participants will be recruited from the medical staff (Non-consultant Hospital Doctors and Consultants) of the neonatal unit.

Eligibility criteria: Inclusion Criteria:

1. Neonatology consultants and NCHD's from CUMH
2. Participants must have completed Neonatal Resuscitation Programme (NRP)
3. Participants must be working as doctors in the area of neonatology

Exclusion Criteria:

1. Any history of cardiac or respiratory disorder
2. Physicians who are post-call

Primary outcomes:
measure: Percentage difference in expired tidal volumes produced by rPAP versus Neopuff resuscitation devices during simulated resuscitation using neonatal mannequins
timeFrame: 1 minutre
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: UCC
Study officials:
References:
Clinical trial NCT06410287: Testing an Arts-based Program to Reduce Nurse Stigma Towards Perinatal Substance Use
Official title: Feasibility of an Art-based Intervention to Address Clinician Stigma and Improve Care for Neonatal Opioid Withdrawal Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Stigma, Social
Implicit Bias
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this pilot clinical trial is to evaluate the feasibility and limited effectiveness of a digital, arts-based educational intervention addressing nurse stigma towards perinatal substance use. The main questions it aims to answer are:

* What is the the feasibility of delivering the training through an asynchronous, web-based platform?
* What is the limited effectiveness of the program on nurse stigma towards perinatal substance use?

Participants will access and complete the training, including completion of a perinatal substance use stigma scale at baseline, immediately post, and 1-2 months month later. Participants will also be invited to participate in an interview.

Researchers will compare the intervention and control groups to see if the training reduces nurse stigma towards perinatal substance use.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Licensed as a registered nurse
* Works at least part time
* Works on a labor, postpartum, nursery, neonatal intensive care, or pediatric unit in one of the participating hospitals

Exclusion Criteria:

* Works as per diem or agency nurse
* Not employed by a participating hospital
* Not a perinatal/pediatric nurse

Primary outcomes:
measure: Nurse Stigma toward Perinatal Substance Use
timeFrame: Measured at baseline, immediately post intervention, 30 days post, and 60 days post
Secondary outcomes:
measure: Acceptability
timeFrame: immediately post intervention
Other outcomes:
Locations:
city: Saint Cloud
country: United States
facility: St. Cloud Hospital
state: Minnesota
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT00635687: Transient Elastography and Variceal Bleeding
Official title: Can Liver Stiffness Values Predict Early Rebleeding in Variceal Rupture
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bleeding
Keywords: variceal bleeding
transient elastography
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Transient elastography is a new non-invasive rapid and reproducible method, allowing evaluating liver fibrosis by measurement of liver stiffness.

The aim of our study is to evaluate if the liver stiffness can predict the recurrence of upper variceal bleeding in cirrhotic patients hospitalized for variceal rupture.


Eligibility criteria: Inclusion Criteria:

* Informed consent form signed
* Social security affiliation
* Variceal bleeding with hematemesis or melena within 24 hours of inclusion
* Age \> 18 years
* Scheduled to undergo endoscopy within 24 hours of hospital admission

Exclusion Criteria:

* Hepatocarcinoma
* Upper Gastro Intestinal bleeding for other causes than variceal bleeding
* Concomitant disease with a life expectancy of less than 45 days
* Rebleeding within 24 hours after first endoscopy
* Technical failure of transient elastography

Primary outcomes:
measure: Bleeding recurrence rate
timeFrame: J45 post first hemorrage
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: UH Amiens
city: Caen
country: France
facility: UH Caen
city: Lille
country: France
facility: UH Lille
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Sophie HERVE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06219187: Male breAsT cAncer preDisposition Factor
Official title: Male breAsT cAncer preDisposition Factor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
PreDisposition factor
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
First posted: 2024-01-23
Enrollment: 93
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a history of male breast cancer (MBC) referenced in the IUCT-O's regional MutaFamily-MBC database.

Brief summary: This is a non-interventional, prospective, single-center study designed to collect and describe environmental and psychosocial data from patients with a history of male breast cancer (MBC) referenced in the IUCT-O regional database.

The study will be conducted on a population of 110 to 150 patients.


Eligibility criteria: Inclusion Criteria:

1. Male patient with a personal history of breast cancer
2. Age ≥ 18 years
3. Patient who has had an oncogenetic consultation at IUCT-O and is registered in the IUCT-O oncogenetic database
4. Patient for whom no pathogenic variant has been detected on the HBOC panel (HBOC-)
5. Patient with no objection to participation in the trial (for deceased patients: trusted support person with no objection to participation).

Exclusion Criteria:

1. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Primary outcomes:
measure: The environmental data in the questionnaire will be described by the usual descriptive statistics.
timeFrame: 15 days for each patient
measure: Psychosocial data from the questionnaire will be described using standard descriptive statistics.
timeFrame: 15 days for each patient
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: IUCT-O
Study officials:
References:
Clinical trial NCT03209687: The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles
Official title: Human Menopausal Gonadotropin as a Novel Addition to Luteal Phase Support in Down-regulated ICSI Cycles (RCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 600
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test the hypothesis that addition of daily small dose of human menopausal gonadotropin (HMG) drug following oocytes retrieval could improve the fertility outcome in women undergoing in-vitro fertilization

Detailed description: The study will be conducted in the IVF unit of Cairo University. Females undergoing ICSI cycles in the age between 20 and 40 years will be allocated to one of 2 groups. Long agonist protocol will be used. Allocation to either one of 2 groups will be done on the day of oocytes retrieval. The first group will take (in addition to the routine care) daily human menopausal gonadotropin drug injection for 2 weeks. The second group will receive the routine care.

Eligibility criteria: Inclusion Criteria:

* Females undergoing Intra-Cytoplasmic Sperm Injection (ICSI) cycles
* Age between 20 and 40 years

Exclusion Criteria:

* Females who have high response (estradiol at time of ovulation trigger is \> 5000 pg/ml or more than 15 oocytes are retrieved)

Primary outcomes:
measure: Live birth rate
timeFrame: This outcome will be calculated 2 years after enrollment of the first patient in the study
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: This outcome will be calculated 2 years after enrollment of the first patient in the study
measure: Implantation rate
timeFrame: This outcome will be calculated 2 years after enrollment of the first patient in the study
measure: Miscarriage rate
timeFrame: This outcome will be calculated 2 years after enrollment of the first patient in the study
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
state: Greater Cairo
Study officials:
affiliation: Cairo University
name: Abdelmaguid Ramzy, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Eman Omran, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03509987: The Evaluation of Point of Care Testing for Determining Hemoglobin Levels in Geriatric Intensive Care Patients
Official title: The Evaluation of Point of Care Testing for Determining Hemoglobin Levels in Geriatric Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Point-of-Care Systems
Lead sponsor: Kecioren Education and Training Hospital
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemaCue (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue at bedside.

Detailed description: The aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemaCue (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue at bedside. Bland Altman Analysis was applied to the results .

Eligibility criteria: Inclusion Criteria:

* geriatric patients requiring intensive care treatment

Exclusion Criteria:

-

Primary outcomes:
measure: hemoglobin levels
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Mehtap Honca
state: Kecioren
Study officials:
affiliation: Kecioren training and research Hospital , Department of Anesthesiology and Reanimation
name: MEHTAP HONCA, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01060787: Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant
Official title: An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Uveitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 98
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects having the fluocinolone acetonide intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one (1) year.

Brief summary: Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants

Detailed description: Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal endothelial cell density.

Eligibility criteria: Inclusion Criteria:

* Had the FA intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one(1) year
* Able and willing to follow instructions
* Able and willing to provide informed consent

Exclusion criteria:

* Is monocular
* Has current or relevant medical history that would interfere with their participation in this study, based on the judgment of the Investigator
* Had bilateral FA intravitreal implants
* Has a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study

Primary outcomes:
measure: Corneal Endothelial Cell Density
timeFrame: 1 Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ophthalmic Partners of Boston
state: Massachusetts
Study officials:
affiliation: Valeant Pharmaceuticals/Bausch & Lomb
name: Johnson Varughese
role: STUDY_DIRECTOR
References:
Clinical trial NCT00826787: Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seizures
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets under fed conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.

Primary outcomes:
measure: bioequivalance based on Cmax
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MDS Pharma Services
state: Arizona
Study officials:
affiliation: MDS Pharma Services
name: Mark Allison, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00275587: Development of a Hospital Service That Uses Critical Pathway (Protocolized) Care Plans to Provide High-Quality, High-Reliability, Evidence-Based Medical Care
Official title: Development of Critical Pathway Care for Hospitalized Patients Using Principles of Patient-Centered Quality Care, Evidence-Based Medicine, and High Reliability Organizational Structure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Pathways
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-01-12
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized at St. Marys Hospital in Rochester, MN with with one of six medical diagnoses: community-acquired pneumonia, deep venous thrombosis or pulmonary embolism, cellulitis, alcohol withdrawal, pyelonephritis, low back pain.

Brief summary: Our broad, long-term objective is to create a new non-resident (non-teaching) hospital service that uses patient-centered critical pathway care plans for treating patients in St. Marys Hospital. This innovative service, the Hospital Medicine (HOME) Team, will integrate three timely, high-priority concepts in healthcare: patient-centered quality care, evidence-based medicine, and principles that define high reliability organizations. The target populations for the new model of service are patients hospitalized with pre-defined admission diagnoses who are expected to require only a brief, focused hospital stay of four days or less. Specifically, we will 1) Design the prototypical approach to be used for developing all critical pathway care plans by integrating patient-centered quality care, evidence-based medicine, and principles that define high reliability organizations, 2) Systematically design the critical pathway care plans for two pre-defined admission diagnoses (community-acquired pneumonia and non-surgical low-back pain), and 3) Compare outcomes of this new service against respective historical patient cohorts for patients admitted with community-acquired pneumonia and non-surgical low-back pain. We anticipate that the prototypic methodology used to develop this patient-centered service will be replicated for other new hospital-service models. To our knowledge, there are currently no existing hospital services in the U.S. that have intentionally integrated principles of high reliability organizations into evidence-based critical pathways founded on patient-centered principles of uncompromising quality.


Eligibility criteria: 1. Hospitalized patient with one of six medical diagnoses: community-acquired pneumonia, deep venous thrombosis or pulmonary embolism, cellulitis, alcohol withdrawal, pyelonephritis, low back pain.
2. Ability and agreement to consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: A. Scott Keller, M.D.
role: PRINCIPAL_INVESTIGATOR
References: