louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06290778: Peer Delivered, Emotion Regulation-Focused Mental Health Prevention Training for Fire Fighter Trainees
Official title: Peer Delivered, Emotion Regulation-Focused Mental Health Prevention Training for Fire Fighter Trainees
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: PTSD
Alcohol Use Disorder
Depression
Anxiety
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Boston University
name: Texas A&M University
First posted: 2024-03-04
Enrollment: 480
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to determine if a peer-delivered emotion regulation training (Brief-Unified Protocol) workshop is effective for preventing posttraumatic stress and other psychological health symptoms in firefighter trainees. The main questions it aims to answer are:

* Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower PTSD symptom severity over time compared to those who receive psychoeducation?
* Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower AUD, depression, anxiety, and functional impairment symptom severity over time compared to those who receive psychoeducation?
* Do changes in neuroticism or emotion regulation mediate the effect of receiving the Brief-Unified Protocol on the treatment outcomes?

Participants will:

* Participate in a Brief-Unified Protocol workshop or psychoeducation workshop during fire academy training.
* Complete a questionnaire prior to the workshop.
* Complete a questionnaire immediately following the workshop and follow up questionnaires at 6, 12, 18, and 24 months after completing the fire academy.

Researchers will compare firefighters who receive a peer-delivered Brief-Unified Protocol workshop to firefighters who receive peer-delivered psychoeducation to see if the Brief-Unified Protocol is effective for preventing posttraumatic stress and other psychological health symptoms.


Eligibility criteria: Inclusion Criteria:

* 21 years of age or older
* English speaking
* Able to sign an informed consent form
* Able to complete the self-report assessment
* Willing to be contacted to complete post and follow-up assessments

Exclusion Criteria:

* Pregnant
* Have plans to relocate within two months of protocol initiation
* Report psychotic symptoms or suicidal behavior within the past 2 weeks
* Are currently dependent on substances other than tobacco or caffeine

Primary outcomes:
measure: PTSD Symptoms
timeFrame: 6, 12, 18, and 24 months
Secondary outcomes:
measure: Alcohol Use Disorder symptoms
timeFrame: 6, 12, 18, and 24 months
measure: Depression symptoms
timeFrame: 6, 12, 18, and 24 months
measure: Anxiety symptoms
timeFrame: 6, 12, 18, and 24 months
measure: Functional Impairment
timeFrame: 6, 12, 18, and 24 months
Other outcomes:
Locations:
city: Waco
country: United States
facility: MacArthur Clinic
state: Texas
Study officials:
References:
Clinical trial NCT06054178: Identification of Nerves Using Fluorescein Sodium
Official title: Intraoperative Nerve Identification with Fluorescein Sodium
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Pleomorphic Adenoma of the Parotid
Warthin Tumor
Head and Neck Disorder
Head and Neck
Thyroid Disease
Thyroidectomy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Experimental: Fluorescein sodium during surgery

Subjects undergoing parotid surgery for benign conditions will have fluorescein sodium administered intravenously after induction, and fluorescence imaging will be performed to visualize nerves intraoperatively
Primary purpose: OTHER

Brief summary: The purpose of this study is to see if there is benefit in using an IV contrast (sodium fluorescein) to identify nerves during head and neck surgery.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects
2. 18 years or older
3. Scheduled for open head and neck surgery

Exclusion Criteria:

1. Inability or unwillingness of a subject
2. Pregnancy
3. Vulnerable or disadvantaged population (pregnant women, decisionally impaired, homeless, employees, students)
4. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
5. History of adverse reaction to fluorescein including allergy.
6. History of renal failure or chronic kidney disease

Primary outcomes:
measure: Facial nerve correlation of Fluorescein Sodium With Electrostimulation
timeFrame: Intraoperative
measure: Correlation of Fluorescein Sodium With Surgeons' Visual Assessment of nerve
timeFrame: Intraoperative
measure: Ratio of Nerve Fluorescence compared to Background Tissue
timeFrame: Intraoperative
Secondary outcomes:
measure: Average Dose of Sodium Fluorescein Administration
timeFrame: Intraoperative
measure: Time to Nerve Visualization
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Tulio Valdez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05731778: Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis
Official title: Clinical Study to Assess Therapeutic Delay and Resolution of Induced Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingivitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2023-02-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate a stannous technology for its effect on the neutrophil phenotype during an induced gingivitis state.

Detailed description: A 9-weeks clinical study will be conducted to evaluate a stannous fluoride dentifrice for therapeutic effects that aim to delay the onset of experimental gingivitis as well as hasten the resolution of disease.

Eligibility criteria: Inclusion Criteria:

1. Male or female volunteers aged 18-70 years
2. In good general health, ASA I
3. No clinical signs of gingival inflammation at \>90% sites observed
4. Probing Depth (PD) \< 3.0 mm
5. Attachment Loss (AL) = 0 mm
6. No periodontal disease history
7. Non-smokers
8. Fluent in English

Exclusion Criteria:

1. Presence of orthodontic bands.
2. Presence of partial removal dentures.
3. Tumour(s) of the soft or the hard tissues of the oral cavity.
4. Cavitated carious lesions requiring immediate restorative treatment.
5. History of allergy to consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study.
6. Participation in any other clinical study or test panel with a one month period prior to entering the study.

Primary outcomes:
measure: Bleeding Index (BOP) and Oral Inflammatory Load
timeFrame: during patient visit over the 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Michael Glogauer, DDS/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03468478: Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation
Official title: Comparison of the Efficacy and Safety of Sirolimus, Everolimus or Mycophenolate in Renal Transplant Recipients Receiving Induction With Anti-thymocyte Globulin, Tacrolimus and Prednisone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant Infection
Lead sponsor: Hospital do Rim e Hipertensão
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 1209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus versus everolimus and tacrolimus versus mycophenolate and tacrolimus.

The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant medical need in the absence of pharmacological prophylaxis.


Eligibility criteria: Inclusion Criteria:

1. Recipients, adults of the first living or deceased donor kidney transplant;
2. Patients who agreed to participate in the study and signed the informed consent form

Exclusion Criteria:

1. Receptors with a medical history of nephrotic syndrome or focal and segmental glomerulosclerosis confirmed as the etiology of end-stage renal disease;
2. Receptors with poor understanding about chronic kidney disease and its treatment alternatives;
3. Receptors with early history of non compliance to treatment with immunosuppressive drugs;
4. Retransplantation;
5. Multi-organ recipients;
6. Recipients with BMI\> 30 kg / m2;
7. KDPI\> 80%;
8. Cold ischemia time greater than 24 hours;
9. Receptors with a percentage of anti-HLA antibodies above 50%, either class I or Class II;
10. Women of childbearing potential who do not undertake contraceptive methods (condoms or oral contraceptives).
11. Patients receiving immunosuppressive therapy prior to transplantation, except low dose of prednisone;
12. Patients with severe uncontrolled dyslipidemia;
13. Patients who have a known contraindication for administration of any of the immunosuppressive drugs provided for in this study;

Primary outcomes:
measure: Incidence of Cytomegalovirus Infection or Disease
timeFrame: 12 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Rim
state: Sao Paulo
Study officials:
References:
Clinical trial NCT00065078: Providing Birth Control Through Home Health Visits
Official title: Effectiveness of Nurse Home Contraceptive Dispensing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Keywords: Home-visits
Community nurse
Unintended pregnancy
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-07-18
Enrollment: 600
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate a program that provides birth control to low income and minority women through home visits by a community health nurse. The goal of the program is to reduce unwanted pregnancies.

Detailed description: Unintended pregnancy is associated with significant public health problems, including inadequate prenatal care, low birth weight infants, infant mortality, and maternal morbidity and mortality. Children born as a result of unplanned pregnancies are at greater risk for poor outcomes such as poor mental health and developmental disabilities. This research project will determine whether providing contraception in the home can reduce the incidence of unintended pregnancy in low income and minority women. The project will also determine whether delaying a pelvic exam encourages or discourages the utilization of clinic-based preventive services to screen for sexually transmitted diseases (STDs) and cervical cancer.

Participants will be randomized to either an experimental group or a comparison group. Each participant will receive family planning counseling during a home visit by a community health nurse. Participants in the experimental group will be offered a three-month supply of oral contraceptives or a depo-provera shot; both forms of contraceptives will be delivered during home visits. Each participant will complete a survey during the initial visit and during a 1-year follow-up. The study will last approximately three years.

Eligibility criteria: Inclusion Criteria:

* Women of child bearing age
* Not pregnant
* Interested in delaying pregnancy using oral contraceptives or a depo-provera shot
* Had sex in the last month or are planning to have sex in the next month
* Have not used contraception during every sexual encounter within 3 months prior to study entry

Primary outcomes:
measure: Pregnancy
Secondary outcomes:
measure: Sexually Transmitted Disease Screening
Other outcomes:
Locations:
city: Oregon City
country: United States
facility: Clackamas County Public Health Division
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alan L Melnick, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01943578: Value of Physical Capacity Tests in Lung Cancer
Official title: Prospective Observational Cohort Study of the Value of the Six Minute Walk Test and Handgrip Strength in Lung Cancer Patients Undergoing Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Small Cell Lung Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 80
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: Non Small Cell Lung Cancer Stage Small Cell Lung Cancer

Brief summary: The study examines the physical capacity of lung cancer patients assessed with the six minute walk test and handgrip strength. Demographic and selfreported exercise behavior is registered to explore correlations to functional and physical capacity.

Assessments are made before first chemotherapy cycle and after fourth chemotherapy cycle, an expected average of 12 weeks between first and second assessment.


Eligibility criteria: Inclusion Criteria:

* Non small cell lung cancer stage I-IV
* Small cell lung cancer
* Patients \>18 years
* WHO performance status 0-2
* undergoing chemotherapy

Exclusion Criteria:

* unstable angina during the previous month
* myocardial infarction diagnosed within the last month
* not approval for physical activity by primary oncologist
* inability to provide informed consent.

Primary outcomes:
measure: Mortality - Survival time
timeFrame: time from first chemotherapy treatment to death, assessed after 30 months
Secondary outcomes:
measure: Hand grip strength
timeFrame: before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.
measure: Self reported exercise behavior
timeFrame: before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.
measure: Six minute walk test
timeFrame: Before first and after fourth chemotheraphy cycle, an expected average of 12 weeks between first and second assessment.
Other outcomes:
measure: FACT-L
timeFrame: Before first chemotherapy and after fourth cycle of chemotherapy, an expected average of 12 weeks between first and second assessment.
Locations:
city: Copenhagen
country: Denmark
facility: University Hospital of Copenhagen
Study officials:
affiliation: University Hospital of Copenhagen, Rigshospitalet
name: Seppo Langer, Phd.
role: STUDY_CHAIR
References:
Clinical trial NCT05454878: Atrial Fibrillation Monitoring on Patients With Lymphoma After Chemotherapy
Official title: A Cohort Study of Atrial Fibrillation Monitoring on Patients With Lymphoma After Chemotherapy by Applying Wearable Electrocardiogram
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: lymphoma
chemotherapy
atrial fibrillation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The new-onset lymphoma patient who was scheduled for chemotherapy

Brief summary: This prospective cohort study is to investigate the incidence of atrial fibrillation after chemotherapy by aplying wearable ECG recoder and the risk factors on patients with newly diagonsed lymphoma

Detailed description: This prospective, single-centre, observational cohort study is disigned to enroll 100 newly diagnosed lymphoma patients who met the inclusion and exclusion criteria to monitor the onset of atrial fibrillation and other arrhythmias during chemotherapy by using wearable ECG recorder, and to evaluate the incidence of atrial fibrillation and related risk factors.

Eligibility criteria: Inclusion Criteria:

1. At least 18 years old;
2. Concurrent chemotherapy on patients with new-onset lymphoma: chemotherapy regimens containing anthracyclines;
3. The subject voluntarily signed the informed consent.

Exclusion Criteria:

1. With heart failure, acute stroke or acute coronary syndrome within 3 months before admission
2. With Atrial fibrillation on admission
3. Patient after pacemaker surgery
4. With mental illness or mentally disabled
5. Patients that the investigator considers as unsuitable for this test

Primary outcomes:
measure: Incidence
timeFrame: 1 year after the first course of chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: General hospital of PLA
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Yundai Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01292278: Constitution of Cerebrospinal Fluid and Blood Database/Specimen in Acute Stage of Subarachnoid Hemorrhage (aSAH) Patients
Official title: The Possible Role of Neuropeptide Y After Spontaneous Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage
Keywords: subarachnoid hemorrhage
cerebral vasospasm
neuropeptide Y
spontaneous
aneurysmal
Lead sponsor: University of Regensburg
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
First posted: 2011-02-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive pts. with subarachnoid hemorrhage

Brief summary: Neuropeptide Y (NPY) may play a major role in the pathophysiology of aneurysmal subarachnoid hemorrhage (aSAH). To investigate the correlation of NPY in cerebrospinal fluid (CSF) and blood (serum) and the neurological outcome in the acute stage of aSAH.

Detailed description: Evaluation of Neuropeptides in CSF and serum in SAH patients

Eligibility criteria: Inclusion Criteria:

* spontaneous or aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

* age younger than 18 years or older than 70 years
* inflammatory disease
* history of former SAH
* no ventricular drainage

Primary outcomes:
measure: Glasgow Outcome Scale
timeFrame: 2011-2016
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Neurosurgery Medical Center University of Regensburg
Study officials:
References:
Clinical trial NCT02159378: Fructosamines and Gestational Diabetes (FRUCTO)
Official title: Fructosamines and Gestational Diabetes (FRUCTO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Gestational Diabetes
Keywords: Gestational Diabetes
Fructosamines
Insulin treatment
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2014-06-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The prevalence of gestational diabetes is estimated at between 2 and 6%, but can be much higher in specific populations.

The specific treatment of gestational diabetes (diet, control weight gain, self monitoring glucose , insulin therapy) reduces complications severe perinatal, fetal macrosomia, and preeclampsia compared with abstention therapy, without additional risk of caesarean section.

Several early studies have shown that the determination of fructosamine is a very bad way of diagnosis for Gestational Diabetes. However, few studies have investigated the relationship between the determination of serum fructosamine and put under insulin in case of Gestational Diabetes.

The purpose of this study is to determine if serum fructosamines rate can be a predictive marker of the starting insulin at the patients suffering from Gestational Diabetes


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Ongoing pregnancy with a start date of pregnancy known and confirmed by an ultrasound of the 1st Quarter performed between 10 and 14 weeks with measurement of the crown-rump length
* Hospitalization for a GD's discovery whatever the term of pregnancy (GD is defined with nationals recommendations of CNGOF)
* Not opposed to participate in the study

Exclusion Criteria:

* Pregnancy uncertain term (absence of early ultrasound)
* Previous diabetes to the pregnancy (type 1 or 2)
* Multiple Pregnancy
* No affiliation to a social security scheme
* Woman with a measure of legal protection

Primary outcomes:
measure: Serum fructosamine rate
timeFrame: at baseline (when gestational diabetes is diagnosed: between 24 and 28 weeks of gestation or later)
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre hospitalier départemental Vendée
Study officials:
affiliation: Centre Hospitalier Départemental Vendée
name: Guillaume DUCARME, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ducarme G, Desroys du Roure F, Grange J, Vital M, Le Thuaut A, Crespin-Delcourt I. Predictive factors of subsequent insulin requirement for glycemic control during pregnancy at diagnosis of gestational diabetes mellitus. Int J Gynaecol Obstet. 2019 Mar;144(3):265-270. doi: 10.1002/ijgo.12753. Epub 2019 Jan 11.