louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06701214: The Clonal Hematopoiesis & Inflammation in Vasculature Registry and Biorepository
Official title: Discovering Outcomes in Clonal Hematopoiesis: The Clonal Hematopoiesis and Inflammation in VasculaturE (CHIVE) Registry and Biorepository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clonal Hematopoiesis
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 800
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: Adults \>/= 18 years old with a mutation known to cause clonal hematopoiesis or at a higher risk of having a clonal hematopoiesis mutation.

Brief summary: This study will investigate the association between clonal hematopoiesis and other conditions. Clonal hematopoiesis (CH) refers to the mutations in a person's stem cells which commonly affect people as they get older. These mutations have notably been linked to increased risk of certain cancers as well as increased risk of heart disease.

Detailed description: Objectives:

* To develop the CHIVE Registry with CH patients or patients with elevated risk for CH in order to better characterize associated clinical outcomes and co-morbidities in these populations
* To improve understanding of cardiovascular phenotypes and risk of patients with known Clonal Hematopoiesis of indeterminate potential (CHIP) or Clonal Cytopenias of undetermined significance (CCUS)
* To investigate prognostic significance of CH mutations for the development hematologic malignancies
* To generate a CHIVE Biorepository to acquire patient samples to study the natural history of CH, and to make available to CH investigators.

Eligibility criteria: Inclusion Criteria:

* Patient greater than or equal to 18 years old at time of consent
* Able to provide informed consent
* Idiopathic cytopenia (ICUS) or idiopathic cytoses (elevated blood counts without disease or explanation); clonal cytopenia of undetermined significance (CCUS), clonal hematopoiesis of indeterminate potential (CHIP) or individuals at higher risk for clonal hematopoiesis (ex. patients with known diagnosis of solid tumors or cardiovascular disease)

Exclusion Criteria:

* Unable to provide consent
* Diagnosis of active hematologic malignancy. For example, a diagnosis of CMML, AML, MDS, MPN; History of hematologic malignancy is NOT exclusionary if in complete remission (e.g. previous myeloma or lymphoma)

Primary outcomes:
measure: CHIVE Registry
timeFrame: Up to approximately 120 months
measure: CHIVE Biorepository
timeFrame: Up to approximately 120 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University/Ingram Cancer Center
name: Alexander Bick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01824914: Airway Evaluation by McGrath Videolaryngoscope
Official title: Comparison of Cormack-Lehane Score in Sedation and Anesthesia Condition by McGrath Videolaryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: videolaryngoscope
tracheal intubation
Cormack-Lehane grade
airway evaluation
sedation
anesthesia
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 97
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Difficult tracheal intubation is a cause of severe patient damage and death. There is not a good method to predict it. The McGrath Series 5 video laryngoscope can improve visualization of the glottic structures one to two grades. Moreover unlike a classical laryngoscope with a Macintosh blade, the McGrath provides a view of the glottis without requiring alignment of the oral, pharyngeal and laryngeal axes. In this study, the investigators will use it to compare the Cormack-Lehane score in sedation and anesthesia condition. It helps to know the role of videolaryngoscope in predicting difficult intubation.

Detailed description: * The enrolled patients were given a bolus of sufentanil 0.3-0.5μg/kg to achieve Ramsay sedation score 2-3. The Cormack-Lehane score in sedation was evaluated by McGrath videolaryngoscope.
* Then the patients were induced with propofol. A bolus of rocuronium was given to facilitate intubation. The Cormack-Lehane score in anesthesia was recorded when intubated by McGrath videolaryngoscope.
* BMI, mouth opening, thyromental distance, intubation duration and ramsay sedation score were also recorded.
* To compare the Cormack-Lehane score in sedate and anesthesia condition

Eligibility criteria: Inclusion Criteria:

* patients scheduled for general surgery under general anesthesia
* ASA classification 1-3

Exclusion Criteria:

* emergent operation, aspiration risk
* a history of difficult airway
* expected difficult airway
* incooperative patients with mental diseases, hearing disorders

Primary outcomes:
measure: Cormack-Lehane score in sedation condition
timeFrame: 5 minutes after administration of sufentanil
measure: Cormack-lehane score in anesthesia condition
timeFrame: 1 minute after administration of rocuronium
Secondary outcomes:
measure: Duration of intubation
timeFrame: At intubation
measure: Sedation score
timeFrame: 5 minutes after administraion of sufentanil
Other outcomes:
measure: BMI
timeFrame: One day before operation
measure: Thyromental distance
timeFrame: One day before operation
measure: Mallampati classification
timeFrame: One day before operation
measure: Mouth opening
timeFrame: One day before operation
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Yuke Tian, Ph.D.,M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04795050: Mitigating Cardiovascular Disease Risk Among Rural Diabetics
Official title: Mitigating Cardiovascular Disease Risk Among Rural Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Promotion
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 146
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial
Primary purpose: PREVENTION

Brief summary: The study explored the effects of the cardiovascular disease risk reduction intervention on diabetes fatalism, self-care activities, social support, knowledge, perceived self-managment among a rural population.

Detailed description: An experimental pretest-posttest control group design was used to assess the effects of a diabetes health promotion intervention among participants recruited from rural churches located in the southern United States. The intervention, called Project Power, is a culturally relevant, church-based diabetes education program that was developed by the American Diabetes Association (ADA). Participating churches were randomized to experimental and control groups using random numbers tables having numerical parity no greater than 2. Since an individual church is the unit of randomization, all of the participants in that church received the same treatment condition. Churches randomized to the intervention group received the health promotion program, and those designated to the control group received an educational brochure. Recruitment, data collection and intervention delivery, for the intervention group, occurred on the church grounds.

Eligibility criteria: Inclusion Criteria:

* Self-identified African Americans aged 22 years or older, who have been diagnosed with Diabetes Mellitus, Type 1 or 2

Exclusion Criteria:

* Other than African American, younger than 22 years of age

Primary outcomes:
measure: Diabetes Self-care Activities
timeFrame: Baseline
measure: Diabetes Knowledge
timeFrame: Baseline
measure: Change from Baseline Diabetes Self-care Activities at Three Weeks
timeFrame: Three weeks after baseline
measure: Change from Baseline Diabetes Knowledge at Three Weeks
timeFrame: Three weeks after baseline
Secondary outcomes:
measure: Diabetes Fatalism
timeFrame: Baseline and three weeks later
measure: Perceived Diabetes Self-Management
timeFrame: Baseline and three weeks later
measure: Social Support
timeFrame: Baseline and three weeks later
measure: Change from Baseline Diabetes Fatalism at Three Weeks
timeFrame: Baseline and three weeks later
measure: Change from Baseline Perceived Diabetes Self-Management at Three Weeks
timeFrame: Baseline and three weeks later
measure: Change from Baseline Social Support at Three Weeks
timeFrame: Baseline and three weeks later
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University College of Nursing
state: Florida
Study officials:
References:
Clinical trial NCT00848250: Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
Official title: Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Cardiopulmonary Bypass
ACE inhibitor
Pediatrics
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 21
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.


Eligibility criteria: Inclusion Criteria:

* Infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect.
* Patients must be taking an ACE inhibitor prior to their operation

Exclusion Criteria:

* Patients in which discontinuing ACEIs is deemed unsafe by their primary cardiologist
* Any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study.
* Pregnancy as ruled out by standard of care screening procedures.
* Individuals whose weight is less than 3.5 kg at the time of enrollment.
* Inability to comply with the protocol. ie. Children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications.

Primary outcomes:
measure: (PAI-1) Plasminogen Activator Inhibitor -1 Antigen
timeFrame: Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1
measure: t-PA (Tissue-type Plasminogen Activator) Antigen
timeFrame: Baseline (prior to surgery) to postoperative day 1
Secondary outcomes:
measure: IL-6 (Interleukin-6)
timeFrame: Baseline (pre-surgery) to postoperative day 1
measure: IL-8 (Interleukin-8)
timeFrame: Baseline (pre-surgery) to postoperative day 1
measure: (MAP) Mean Arterial Blood Pressure
timeFrame: Baseline (prior to surgery) to postoperative day 1
measure: Postoperative Bleeding
timeFrame: 24 hours
measure: Postoperative Renal Function
timeFrame: Baseline (prior to surgery) to postoperative day 1
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center, Division of Pediatric Cardiology
name: Gregory A Fleming, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center, Department of Anesthesiology
name: Mias Pretorius, MBChB, MSCI
role: STUDY_DIRECTOR
References:
Clinical trial NCT01005550: Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery
Official title: Determining the Minimum Effective Ropivacaine Dose for Unilateral Hypobaric Spinal Anaesthesia During Traumatic Femoral Neck Surgery in the Aged Person: Prospective Comparative Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Femoral Neck Fracture
Keywords: Unilateral spinal anaesthesia
Hypobaric anaesthesia
Ropivacaine
Traumatic hip surgery
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 64
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, monocentric, randomized study, comparing the effectiveness and tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal anaesthesia during traumatic femoral neck surgery in the elderly.


Eligibility criteria: Inclusion Criteria:

* older than 70
* dorsal decubitus surgery
* ASA score 1, 2, 3
* MMS score \> or equal to 25

Exclusion Criteria:

* local anesthetic allergy
* spinal anaesthetic exclusion
* MMS score lower than 25

Primary outcomes:
measure: Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery.
timeFrame: 1 hour (surgery intervention)
Secondary outcomes:
measure: Spinal anaesthesia characteristics
timeFrame: 1 hour (surgery intervention)
measure: Hemodynamics consequences
timeFrame: 1 hour (surgery intervention)
measure: Patient and surgeon satisfaction
timeFrame: 1 hour (surgery intervention)
measure: Morbidity and mortality
timeFrame: During 3 days after surgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Pascal MEURET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lilot M, Meuret P, Bouvet L, Caruso L, Dabouz R, Deleat-Besson R, Rousselet B, Thouverez B, Zadam A, Allaouchiche B, Boselli E. Hypobaric spinal anesthesia with ropivacaine plus sufentanil for traumatic femoral neck surgery in the elderly: a dose-response study. Anesth Analg. 2013 Jul;117(1):259-64. doi: 10.1213/ANE.0b013e31828f29f8. Epub 2013 Apr 16.
Clinical trial NCT05902650: Correlation of Biochemical Indexes and Retinal Hemodynamic in Patients With Different Degrees of Diabetic Retinopathy
Official title: Correlation of Biochemical Indexes and Retinal Hemodynamic in Patients With Different Degrees of Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Retinopathy
Lead sponsor: The Seventh Affiliated Hospital of Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetic patients

Brief summary: All OCTA data and biochemical indexes of diabetic patients were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.

Detailed description: Diabetic patients at the Department of Ophthalmology of the Seventh Affiliated Hospital of Sun Yat-sen University were selected as research participants. All OCTA data and biochemical indexes were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of diabetes

Exclusion Criteria:

* various other types of retinal and choroidal disease;
* history of any intraocular surgery or treatment (including intravitreal injection, retinal photocoagulation etc.
* with severe refractive medium opacity that could affect fundus examination.

Primary outcomes:
measure: fasting blood glucose (FBG)
timeFrame: the time of the patient's first 1 day visit
measure: glycosylated hemoglobin (HbAlc)
timeFrame: the time of the patient's first 1 day visit
measure: OCTA data
timeFrame: the time of the patient's first 1 day visit
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: The Seventh Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Seventh Affiliated Hospital of Sun Yat-sen University
name: Mingzhe Cao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05181150: Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury
Official title: Gut Peptides and Bone Remodeling in Individuals With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal cord injury
GIP
GLP-2
CTX
P1NP
Bone resorption
Bone formation
Bone turnover
Bone remodeling
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2022-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Both GLP-2 and GIP reduce bone resorption (measured as CTX) in healthy persons. In this study, we will investigate whether GLP-2 and GIP is reducing CTX in individuals with spinal cord injury.


Eligibility criteria: Inclusion Criteria (Individuals with spinal cord injury):

* Spinal cord injury resulting in the need of a wheelchair
* BMI: 16-32 kg/m2

Inclusion Criteria (Healthy controls):

* Intact spinal cord
* Matched on gender, age and BMI to the group with spinal cord injury

Exclusion Criteria:

* Treatment with antidiabetics
* Treatment with anti-resorptive agents
* Gastrointestinal disease
* Smoking
* Long term steroid treatment
* Weight change more than 3 kg within the last 3 months.
* Overweight or intestinal surgery

Primary outcomes:
measure: CTX
timeFrame: -10 to 240 minutes
Secondary outcomes:
measure: P1NP
timeFrame: -10 to 240 minutes
measure: PTH
timeFrame: -10 to 240 minutes
measure: Sclerostin
timeFrame: -10 to 240 minutes
measure: Glucose
timeFrame: -10 to 240 minutes
measure: Insulin
timeFrame: -10 to 240 minutes
measure: C-peptide
timeFrame: -10 to 240 minutes
measure: GIP
timeFrame: -10 to 240 minutes
measure: GLP-2
timeFrame: -10 to 240 minutes
measure: Glucagon
timeFrame: -10 to 240 minutes
measure: Blood pressure
timeFrame: -10 to 240 minutes
measure: Heart rate
timeFrame: -10 to 240 minutes
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: University of Copenhagen
name: Mette M Rosenkilde, Prof., MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06377150: Stargardt Disease in Childhood
Official title: Stargardt Disease in Childhood - a Single-center Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stargardt Disease
Keywords: Stargardt Disease
ABCA4
inherited retinal dystrophy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with genetically confirmed ABCA4-associated inherited retinal dystrophy.

Brief summary: Retrospective chart review study to elucidate the phenotype and genotype of children with ABCA4-associated Stargardt disease.


Eligibility criteria: Inclusion Criteria:

* genetically confirmed ABCA4-associated inherited retinal dystrophy

Exclusion Criteria:

* 18 years old and older

Primary outcomes:
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: January 2014 - May 2021
measure: Visual Field (VF)
timeFrame: January 2014 - May 2021
measure: Fundus Photography (FP)
timeFrame: January 2014 - May 2021
measure: Fundus Autofluorescence (AF)
timeFrame: January 2014 - May 2021
measure: Optical Coherence Tomography (OCT)
timeFrame: January 2014 - May 2021
measure: Full-Field Electroretinography (ff-ERG)
timeFrame: January 2014 - May 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
state: Baden-Wuerttemberg, Germany
Study officials:
affiliation: Centre for Ophthalmology, University of Tuebingen
name: Laura Kuehlewein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Molecular Genetics Laboratory, Centre for Ophthalmology, University of Tuebingen
name: Susanne Kohl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05088850: The Early Prediction of Sepsis in ICU
Official title: The Early Prediction of Sepsis Occurrence in ICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prediction of Sepsis in Critical Patients
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 400
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients that were admitted into the ICU.

Brief summary: Sepsis is a vital issue in critical care medicine, and early detection and intervention are key to survival. We aimed to establish an early warning system for sepsis based on a data integration platform that can be implemented in the ICU.


Eligibility criteria: Inclusion Criteria:

Patients who met all of the following criteria were included in the case group:

1. At least 14 years old.
2. Sepsis onset at least 5 hours after ICU admission.
3. Sepsis onset is the first instance since admission to the hospital.

Exclusion Criteria:

Patients meeting all of the following criteria were included in the control group:

1. At least 14 years old.
2. Patients staying in ICU for at least 5 hours and have not had sepsis in this time.
3. Patients without ICD-9 codes for sepsis (785·52, 995·91, 995·92).
4. SOFA score change is not more than 1 point in an arbitrary continuous 72 hours in the ICU stay.

Primary outcomes:
measure: confidence index of sepsis occurrence
timeFrame: sepsis occurrence in five hours
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ICU, Ruijin Hospital
state: Shanghai
Study officials:
References: