louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06764992: Exploring Men s Prostate Cancer Genetic Risk Perceptions
Official title: Exploring Men s Prostate Cancer Genetic Risk Perceptions and Willingness to Give a Biospecimen for Genetic Risk Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Genetic Risk Perception and Beliefs
Biospecimen Donation for Genetic Risk Testing
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Racially and ethnically diverse Adult Men with no personal Prostate Cancer history/diagnosis.

Brief summary: The exploring men's prostate cancer genetic risk perceptions and willingness to give a biospecimen for genetic risk testing study aims to assess prostate cancer genetic risk and susceptibility beliefs among unaffected men of diverse races/ethnicities who are considering undergoing prostate cancer screening and their willingness of men to provide a biospecimen (saliva sample) and test the samples for prostate cancer aggressiveness and determine risk category based on SNP genetic profile.


Eligibility criteria: Inclusion Criteria:

* Racially/ethnically diverse men with emphasis on Men of African Ancestry.
* Age 40 and older .
* No personal prostate cancer history/diagnosis.
* With or without family history of prostate cancer.

Exclusion Criteria:

* Previous personal Prostate Cancer history/diagnosis
* Under 40 years of age

Primary outcomes:
measure: Prostate Cancer Genetic Risk and Susceptibility Beliefs
timeFrame: Up to 6 Months
Secondary outcomes:
measure: Polygenic Risk Score (PRS) of Saliva Samples
timeFrame: Up to 6 Months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Jong Park, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02907892: Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications: A Randomized Controlled Trial
Official title: Effect of Intra-operative Glove-changing During Cesarean Section on Post-op Complications:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Complications
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: HealthPartners Institute
First posted: 2016-09-20
Enrollment: 554
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A randomized controlled trial to determine whether changing of gloves by the surgical team during cesarean section may decrease post-operative infectious morbidity and wound complications

Detailed description: This was a randomized, single-blind controlled trial of women who underwent cesarean section at Healthpartners Regions Hospital. Potential participants were identified during routine obstetrical care of singleton pregnancies at Regions Hospital, at the time that cesarean section was decided as the route of delivery by patient and provider. Patients were excluded if the cesarean section was performed emergently. Randomization occurred in the operating room during preparation for cesarean section; nursing staff drew a computer generated allocation card from a stack placed within an envelope in the room. Patients assigned to the control group underwent cesarean section with standard surgical technique at the discretion of the attending surgeon. Patients assigned to the glove change group underwent cesarean section in which the surgical team - surgeon, assistant, and scrub nurse - replaced their outer surgical gloves with a new sterile pair of gloves prior to abdominal closure. Abdominal closure was considered to begin with closure of the peritoneum, if performed, otherwise with closure of the abdominal fascia.

Eligibility criteria: Inclusion Criteria:

* Pregnant woman with singleton pregnancy and shared decision making with provider resulting in plan for cesarean section

Exclusion Criteria:

* Severe immunocompromise (AIDS) or emergent nature of cesarean section

Primary outcomes:
measure: Composite Wound Complication
timeFrame: Within 8 weeks following cesarean section
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jonathan Scrafford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04497792: Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions
Official title: A Long-term, Randomized Study to Evaluate the Effects of Empagliflozin in Combination With Standard Hypoglycemic Therapy on Early and Long-term Results of Planned Percutaneous Coronary Interventions in Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Diabetes Mellitus
Percutaneous Coronary Intervention
Keywords: stable coronary artery disease
empagliflozin
Lead sponsor: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To study the effectiveness and safety of empagliflozin as a preoperative preparation tool, as well as to improve the long-term prognosis of planned percutaneous coronary interventions in patients with type 2 diabetes

Detailed description: Patients with type 2 diabetes will be randomized into 2 groups using the envelope method. One group will receive empagliflozin 10 mg 1 month before planned percutaneous coronary interventions and for 12 months thereafter in addition to previously taken hypoglycemic therapy. Patients of the second group will continue to take previously prescribed hypoglycemic therapy.

Thus, the safety and effectiveness of empagliflozin for preoperative preparation of patients with type 2 diabetes before planned percutaneous coronary interventions will be evaluated, as well as the impact on the immediate and long-term outcomes of percutaneous coronary interventions in comparison with patients on standard hypoglycemic therapy

Eligibility criteria: Inclusion Criteria:

* signed inform concent
* stable coronary artery disease
* planned percutaneous coronary intervention
* diabetes mellitus

Exclusion Criteria:

* previously performed coronary revascularization
* glomerular filtration rate less than 45 ml/min
* intolerance to empagliflozin
* serum potassium more than 5/5 mmol/l
* heart failure (NYHA III-IV)
* congenital heart disease
* acute coronary syndrome less than 3 months before enrollment

Primary outcomes:
measure: glomerular filtration rate(GFR)
timeFrame: baseline-24 weeks
measure: HbA1C level
timeFrame: baseline-24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Research Institute for complex issues of cardiovascular diseases
name: Olga Barbarash
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01736592: Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration
Official title: An Open Label Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients With Stargardt's Macular Degeneration
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Stargardt's Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Primary Objective:

To evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt's Macular Degeneration.

Secondary Objective:

To assess:

* Safety
* Biological activity

Detailed description: Patients will be followed for 15 years after completion/early termination from the previous TDU13583 study (NCT01367444).

As the initial TDU13583 study is terminated - recruitment to this LTS13588 study is over with 27 patients enrolled.

Eligibility criteria: Inclusion Criteria:

Patients must meet ALL of the following criteria:

1. Provide signed and dated written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \[HIPAA\])
2. Must have been enrolled in protocol TDU13583 (SG1/001/10)
3. Must have received a subretinal injection of SAR422459
4. Must have completed protocol TDU13583 to Week 48 or undergone an early discontinuation visit.

Exclusion Criteria:

The following would exclude Patients from participation in the study:

1. Did not receive SAR422459 as part of the TDU13583 protocol.

Primary outcomes:
measure: The incidence of Adverse Events
timeFrame: 15 years
Secondary outcomes:
measure: Clinically important changes in ocular safety assessments
timeFrame: baseline to 15 years
measure: Delay in retinal degeneration
timeFrame: baseline to 15 years
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University Site Number : 840001
state: Oregon
city: Paris
country: France
facility: Investigational Site Number : 250001
Study officials:
References:
Clinical trial NCT00645944: Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
Official title: Randomized, Controlled, Double Blind Trial of Eszopiclone for Insomnia Associated With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Schizophrenia
Schizoaffective Disorder
Sleep Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Sumitomo Pharma America, Inc.
First posted: 2008-03-28
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The major goal of this project is to investigate established insomnia treatments in a schizophrenia population to see if the improved sleep leads to overall better quality of life. In addition, we hypothesize that the insomnia treatment may also lead to observed improvements in other symptoms associated with schizophrenia such as cognitive impairments, obesity, and negative symptoms.

Detailed description: The primary aim of this study is to investigate the clinical efficacy of eszopiclone for the treatment of schizophrenia-related insomnia over 8 weeks. A two-week, single-blind placebo phase followed the double-blind phase to evaluate rebound and withdrawal effects after abrupt discontinuation.

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18 to 64
* Meet DSM-IV criteria for schizophrenia or schizoaffective disorder
* Sleep difficulties at least 2x per week in the preceding month
* Be on a stable dose of antipsychotic medication
* Symptomatically stable in the last 2 months
* English speaking.

Exclusion Criteria:

* Meet criteria for current alcohol or other substance dependence
* A history of dementia, mental retardation or other neurological disorder
* Not capable of giving informed consent for participation in this study.
* Ongoing pregnancy
* Known sensitivity to zopiclone.
* Insomnia associated with medical disorders likely to impair sleep.
* Use of any medication that affects sleep/wake function (other than antipsychotic medication), within the past 2 weeks or within a time period that is less than 7 half-lives since last use of the medication.
* Lack of sleep benefit from previous adequate eszopiclone treatment
* History of clinically significant hepatic impairment.
* Subject is taking a potent cytochrome p450 3A4 inhibitor medication (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication.

Primary outcomes:
measure: Change in Insomnia Severity Index From Baseline.
timeFrame: 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Cenk Tek, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04517344: High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study
Official title: High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study - A Single Center, Randomized Controlled, Feasibility Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiolitis
Keywords: Bronchiolitis
HFNC
High Flow Nasal Cannula
Infants
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 21
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose an open label, non-blinded, single center randomized controlled feasibility study to find the optimal initial HFNC flow rate in children less than 12 months old with clinically diagnosed moderate to severe bronchiolitis. This feasibility study is projected over December 2020 to April 2023. The study is consisted of 3 arms, comparing HFNC therapy at 1 L/kg/min, 1.5 L/kg/min, and 2 L/kg/min (20 L/min max). Moderate to severe bronchiolitis is defined clinician's assessment for the need for ICU level of care.

The primary outcome is treatment response to HFNC therapy defined by RDAI/Respiratory Assessment Change Score (RACS) ≥ 4 at 4 hours of therapy. Secondary outcome measures comprise of treatment failure requiring an escalation of care during the first 24 hours of HFNC therapy, duration of HFNC and simple nasal cannula therapy, duration of simple nasal cannula therapy, hospital and PICU length of stay (LOS), time to treatment failure, and adverse events.


Eligibility criteria: Inclusion Criteria:

* Patients less than 12 months of age
* Clinical signs of moderate to severe bronchiolitis defined by American Academy of Pediatrics
* Requires ICU level of care by clinicians' discretion
* Requiring HFNC support

Exclusion Criteria:

* Infants who required immediate need for respiratory support such as non-invasive positive pressure ventilation (NIPPV) or invasive ventilation
* Congenital heart disease,
* Immunocompromised state
* Upper airway obstruction
* Chronic lung disease
* Bronchopulmonary dysplasia,
* Home oxygen therapy requirement
* Acute trauma patients
* Baseline craniofacial malformations
* Admitted to the neonatal or cardiac ICUs
* Patients who are admitted to the floor

Primary outcomes:
measure: Treatment response to HFNC Therapy
timeFrame: 4 hours of therapy
Secondary outcomes:
measure: Treatment failure to HFNC Therapy
timeFrame: 24 hours from time of study
measure: Length of oxygen support
timeFrame: 24 hours from time of study
measure: Length of stay
timeFrame: 24 hours from time of study
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Health - Children's Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Amy Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06027944: Impact of Light on Mood
Official title: More Than Meets the Eye? The Impact of Light on Mood Regulation in Humans
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: Stanford University
First posted: 2023-09-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators are examining whether the content of a visual scene impacts the antidepressant effects of light or if this impact is solely mediated by the intensity of the light.


Eligibility criteria: Inclusion Criteria:

* Aged 18-60
* Mild depressive symptomatology

Exclusion Criteria:

* No depressive symptomatology
* Severe depressive symptomatology
* Active or unstable medical condition
* Diabetes

Primary outcomes:
measure: Change in mood
timeFrame: 15 minutes
Secondary outcomes:
measure: Change in fast brain electrical activity
timeFrame: 15 minutes
measure: Change in systolic blood pressure (SBP)
timeFrame: 15 minutes
measure: Change in heart rate variability (HRV)
timeFrame: 15 minutes
measure: Change in sympathetic activity
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References:
Clinical trial NCT01264744: Detection of Chromosomal Aberrations in Urine Samples Using Fluorescent in Situ Hybridization (FISH) (UroVysion Test)
Official title: Concordance Study for Detection of Chromosomal Aberrations Using FISH in Urine Samples Sections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancers
Keywords: Bladder cancer
Chromosomal aberrations
FISH
Urine sample
Lead sponsor: Applied Spectral Imaging Ltd.
Sponsor class: INDUSTRY
First posted: 2010-12-22
Enrollment: 174
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with hematuria that are suspected in having bladder carcinoma, and in patients previously diagnosed with bladder cancer.

Brief summary: The purpose of the study is the identification of chromosomal aberrations in urine samples.

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classification of UroVysion FISH stained Urine samples.

Detailed description: The FISH test detect chromosomal aberrations in urine specimens from persons with hematuria suspected of having bladder cancerous using the UroVysion® Bladder Cancer Kit (UroVysion Kit) which is FDA approved. This kit is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus. Results from the UroVysion Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

Eligibility criteria: Inclusion Criteria:

* Well stained slides with bright FISH signals

Exclusion Criteria:

* Very old slides that were already bleached

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Hospital
state: California
city: Union
country: United States
facility: PLUS Diagnostics
state: New Jersey
city: Temple
country: United States
facility: Sheila Dobin, Ph.D.
state: Texas
Study officials:
affiliation: Section Chief, Cytogenetics
name: Sheila - Dobin, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00148044: Uremic Toxins of Patients With Acute Kidney Failure
Official title: Uremic Toxins of Patients With Acute Kidney Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure, Acute
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2005-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Determination of the concentration of uremic toxins of sepsis patients with or without acute kidney failure compared to the concentrations of uremic toxins of chronically uremic patients

Detailed description: Determination of the concentration of uremic toxins of sepsis patients with or without acute kidney failure compared to the concentrations of uremic toxins of chronically uremic patients

Eligibility criteria: Inclusion Criteria:

* Intensive Care patients with sepsis
* Patients with acute kidney failure: serum creatinin \> 2 mg/dl
* Chronic haemodialysis patients

Exclusion Criteria:

* \< 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Raymond Vanholder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00115544: Safety and Pharmacology of Stanate
Official title: An Open-Label Study of the Safety and Clinical Pharmacology of Stanate® in Infants At-Risk for Exchange Transfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperbilirubinemia
Keywords: neonatal
jaundice
hyperbilirubinemia
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: National Children's Hospital, Vietnam
First posted: 2005-06-23
Enrollment: 55
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in infants who are at risk for an exchange transfusion and meet the criteria of the protocol.

Detailed description: The present study evaluated the relationship between Stanate® dose, drug safety, and efficacy in a non randomised sequential open label cohort design, in 55 patients. Subjects were term and near term infants at medium or high risk of hyperbilirubinemia with TSB levels approaching the threshold for exchange transfusion. The first cohort began at a dose of stannsoporfin 0.75 mg/kg of birth weight intramuscularly. The dose was then increased to 1.5 mg/kg for cohort 2, and saline was given (placebo) for cohort 3. Safety evaluations consisted of hepatic, renal and hematologic clinical laboratory tests along with serial physical examinations. Long term follow up of all patients to age 6 is planned.

Eligibility criteria: Inclusion Criteria:

* Term and near-term healthy infants (may be no more than 14 days of age) with excessive hyperbilirubinemia who are at risk for exchange transfusion according to the AAP guidelines of 2004

Exclusion Criteria:

* No parental consent
* Major known congenital anomaly
* Current use of antibiotics, cardio-respiratory instability, abnormal renal function, hepatitis (as related to TORCH infections)
* Phenobarbital use in either child or mother (30 days prior to child's birth)

Primary outcomes:
measure: Reduction of serum bilirubin levels; need for exchange transfusion, safety parameters
timeFrame: 30 days with long term f/u
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National hospital of pediatrics
Study officials:
References: