louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05317546: Cannabidiol in Youth Alcohol Use Disorder
Official title: Neurobehavioral Effects of Cannabidiol in Youth Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test cannabidiol (CBD) as a potentially effective candidate medication for youth alcohol use disorder (AUD). To accomplish this goal, this study will use a randomized, double-blind, within-subjects crossover design. In counterbalanced order, 50 youth (ages 16-22) will receive 600 mg of CBD or placebo three hours before a neuroimaging and behavioral assessment paradigm. The total amount of time the participant will be in the study is approximately one month.


Eligibility criteria: Age 16 to 22. Does or does not drink alcohol.

Primary outcomes:
measure: Glutamate
timeFrame: Changes 3 hours after administration of 600mg CBD vs. placebo
measure: GABA
timeFrame: Changes 3 hours after administration of 600mg CBD vs. placebo
measure: Alcohol cue reactivity neural activation
timeFrame: Changes 3 hours after administration of 600mg CBD vs. placebo
measure: Alcohol cue reactivity (lab-based paradigm)
timeFrame: Changes 3 hours after administration of 600mg CBD vs. placebo
measure: Alcohol cue reactivity (lab-based paradigm)
timeFrame: Changes 3 hours after administration of 600mg CBD vs. placebo
measure: Alcohol cue reactivity (lab-based paradigm)
timeFrame: Changes 3 hours after administration of 600mg CBD vs. placebo
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT02868346: Improving the Diagnosis of Sexually Transmitted Infections in Emergency Rooms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexually Transmitted Infection
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 303
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of sexually transmitted infections caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC sexually infection transmitted tests .

Most sexually transmitted infections can be diagnosed from an anal swab which is not routinely performed. In this study, we suggest to test the hypothesis that anal swab in addition to the routine genital swab would increase by at least 5% the diagnosis capacity of sexually transmitted infections after the POC tests.


Eligibility criteria: Inclusion Criteria:

* Patient admitted for sexually transmitted infection in emergency room requiring a microbiological examination with a "Sexually Transmitted Infection POC kit"
* Patient who freely signed the informed consent form
* Patient affiliated to a social security regime

Exclusion criteria

* Pregnant or breastfeeding women
* Adult patient under guardianship
* Patient deprived with liberty under court order
* Patient refusing or unable to sign the informed consent form

Primary outcomes:
measure: Percentage of patients with a confirmed etiological diagnosis of sexually transmitted infection
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT05324046: Comparison Between LDCT With DL Recontruction and Standard Dose CT
Official title: Comparison of Low Dose Contrast Enhanced Abdominal CT With Deep Learning Reconstruction With Standard Dose CT With Iterative Reconstruction in Patients With Suspected Liver Metastases: A Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Liver Metastases
Keywords: CT
metastasis
liver
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 134
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are referred to Radiology department for undergoing contrast-enhanced abdomen CT.

Brief summary: This prospective study aims to perform intra-individual comparison of the image quality between low dose liver CT with deep learning reconstruction and standard dose liver CT with iterative reconstruction in patients with liver metastasis.


Eligibility criteria: Inclusion Criteria:

* patients with underlying malignancy and suspicion of liver metastasis
* patients with known liver metastasis and on follow-up
* AND scheduled for contrast enhanced abdomen CT
* signed informed consent

Exclusion Criteria:

* absolute or relative contra-indication for contrast-enhanced CT
* diffuse infiltrative liver lesion or multiple (\> 10) metastases

Primary outcomes:
measure: liver lesion conspicuity
timeFrame: 6 months after the CT scan
Secondary outcomes:
measure: liver lesion detectability
timeFrame: 6 months after the CT scan
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03231046: Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/CBCT)
Official title: Modality Augmentation for Navigation: Intuitive Fusion With Optical Lightweight Device (US/CBCT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hepatic Biopsy or Ablation
Lead sponsor: Clear Guide Medical
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
First posted: 2017-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this research is to evaluate functional validation of the CBCT-US fusion for the Clear Guide SCENERGY system, as well as to evaluate benefits derived from system performance.

Detailed description: Human subjects are proposed to validate the CBCT-US fusion aspects of the Clear Guide SCENERGY product. For these modalities, Clear Guide Medical will work with the subcontract PI to determine the appropriate clinical procedure to evaluate (1) functional validation of the fusion system and (2) benefits derived from system performance. The selected procedure must be a single-patient interaction (i.e., no follow-up visits). Clinical studies will require approval through the subcontract's IRB. The Clear Guide SCENERGY will be compared to standard clinical practice (either no fusion or an electromagnetic-based fusion system). Clear Guide Medical plans to determine sample size based upon statistical powering for a predetermined clinically-meaningful difference (delta). This delta has not been selected, because this depends on the procedure selected. The anticipated sample size is expected to be around 100 subjects (i.e., 50 per arm), per modality. Blinding will be used, where possible. Clinician-related endpoints cannot be blinded due to obvious equipment differences. Subjects will be placed into treatment group by random. Retention strategies are unnecessary, as there will not be any planned follow-up visits or activities.

Eligibility criteria: Inclusion Criteria:

* Undergoing radiological, oncological, or urological intervention procedures
* Able to give written informed consent

Exclusion Criteria:

* Unable to give informed consent
* Vulnerable populations and children

Primary outcomes:
measure: Success of needle placement
timeFrame: Immediately following intervention (within 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06731946: Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms
Official title: Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Arterial Aneurysm
Keywords: Intracranial Arterial Aneurysm
Surpass Evolve Flow Diverter
Lead sponsor: Shanghai Fourth People's Hospital Tongji University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese populations with intracranial aneurysms

Brief summary: Safety and Efficacy of the Surpass Evolve Flow Diverter in Treating Intracranial Aneurysms

Detailed description: This study aims to retrospectively evaluate the efficacy and safety of the Surpass Evolve Flow Diverter in treating complex intracranial aneurysms. It seeks to assess long-term outcomes and complication rates while analyzing the impact of patient characteristics and aneurysm types on treatment effectiveness. By collecting data from multiple centers, the study ensures broad representativeness, ultimately providing valuable insights for clinical management on a global scale.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years with a confirmed diagnosis of intracranial aneurysm.
2. Imaging studies confirming suitability for Surpass Evolve Flow Diverter treatment.
3. Aneurysms meeting flow diverter treatment indications (e.g., aneurysms larger than 4 mm).
4. At least six months of follow-up data available post-treatment.

Exclusion Criteria:

1. Patients with acutely ruptured aneurysms or significant bleeding.
2. Patients with incomplete data or insufficient follow-up records.

Primary outcomes:
measure: Complete aneurysm occlusion rate
timeFrame: 12(-3 ~ +6) months
measure: Favorable prognosis rate
timeFrame: 12(-3 ~ +6) months
measure: Procedure-related complication rate
timeFrame: 12(-3 ~ +6) months
Secondary outcomes:
measure: Procedural success rate
timeFrame: 12(-3 ~ +6) months
measure: Perioperative complication rate
timeFrame: 12(-3 ~ +6) months
measure: Neurological mortality rate
timeFrame: 12(-3 ~ +6) months
measure: Incidence of postoperative stroke/TIA
timeFrame: 12(-3 ~ +6) months
measure: Rates of postoperative intracranial hemorrhage and neurological deficits
timeFrame: 12(-3 ~ +6) months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Fourth People's Hospital
Study officials:
References:
Clinical trial NCT06925646: Hand Perfusion and Pulse Oximetry Performance
Official title: Hand Perfusion and Pulse Oximetry Performance
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Oxygen Saturation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of men and women of all races and ethnic backgrounds recruited from faculty and staff of the Mayo Medical Center and from Rochester, MN and surrounding communities.

Brief summary: The purpose of this study is to compare oxygen saturation measurement readings from manufactured pulse oximetry devices to the oxygen saturation measurements of arterial blood samples drawn at the same time of measurements.


Eligibility criteria: Inclusion Criteria:

* Healthy adult men and women of all races and ethnic backgrounds recruited from faculty and staff of the Mayo Medical Center and from Rochester, MN and surrounding communities.
* Equal number of male and female participants to address potential sex differences in physiology.
* We will intentionally recruit subjects with dark skin because of the issues surrounding accuracy of pulse oximetry and skin tone.
* Non-smokers
* BMIs between 18-30 kg·m-2.
* Female subjects will be non-pregnant.
* Free of cardiopulmonary diseases or other conditions and/or taking medications that might affect pulse oximeter-based estimates of arterial saturation.
* All inclusion and exclusion criteria are at the discretion of the Principal Investigator.
* At least 8 of the subjects will have Fitzpatrick Skin Type of IV to VI.

Exclusion Criteria:

• Children under the age of 18 will not be studied. We will exclude children less than 18 years of age because they are unable to give consent, and because these studies are non-therapeutic.

Primary outcomes:
measure: Arterial oxygen saturation measured via arterial blood gas sample (Sa02)
timeFrame: 30 minutes, 90 minutes, 3 hours
measure: Arterial oxygen saturation measured via pulse oximeters (Sp02)
timeFrame: 30 minutes, 90 minutes, 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Department of Anesthesiology
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Joyner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00692146: Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)
Official title: A Double-Blind, Randomized, Single-Centre, Placebo-Controlled, Crossover Study to Investigate the Effects of a Single Oral Dose of AZD1386 on Intradermal Capsaicin Evoked Pain Symptoms and Heat Sensitivity in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Capsaicin Evoked Pain
Heat Sensitivity
Keywords: Proof of Mechanism
Capsaicin evoked pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms and heat sensitivity in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Clinical normal physical findings, including BP, pulse rate \>45 bpm, ECG and laboratory assessments
* Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg.
* Non-fertile females

Exclusion Criteria:

* History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.

Primary outcomes:
measure: VAS, HPT
timeFrame: Visit 2-4
Secondary outcomes:
measure: eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia
timeFrame: Visit 2-4
measure: Vital signs, laboratory variables and adverse event each day throughout the study. paper printout ECG and/or digital ECG throughout the study. Pain evoked assessments visit 1-3
timeFrame: Visit 1-5
measure: Pharmacokinetics/Pharmacodynamics
timeFrame: Visit 2-4
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca R&D Södertälje
name: Agneta Berg
role: STUDY_CHAIR
affiliation: AstraZeneca R&D CPU Karolinska University Hospital, Stockholm
name: Ingemar Bylesjö
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02053246: Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure
Official title: Improving Treatment Personalization of Pulmonary Hypertension Associated With Diastolic Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pulmonary Hypertension
Diastolic Heart Failure
Heart Failure With Preserved Ejection Fraction
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2014-02-03
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Heart failure with preserved ejection fraction (HFpEF), is one of the leading causes of pulmonary hypertension (PH). Despite the severity of this disease, no established treatments exist for this class of PH. Nebivolol is a drug used in high blood pressure and heart failure, but not used in patients with PH. Due to some additional properties it possesses, the investigators believe nebivolol will improve disease severity in patients with PH associated with HFpEF. The hypothesis of this research study is that nebivolol improves PH severity in patients with HFpEF, as measured by hemodynamic and clinical parameters.

Detailed description: This research study will be a prospective, open-label 18-week clinical study of nebivolol in patients with PH associated with HFpEF. Patients will be identified in clinic based on echocardiogram (TTE) and right heart catheterization (RHC) results (both part of standard clinical care) indicating PH and HFpEF.

Eligibility criteria: Inclusion Criteria:

* Adults (≥ 18 years of age) with World Health Organization Group 2 Pulmonary Hypertension (Mean pulmonary artery pressure ≥ 25 mmHg and pulmonary capillary wedge pressure ≥ 15 mmHg)
* New York Heart Association class II-IV symptoms
* Left ventricular ejection fraction (LVEF) ≥ 45%

Exclusion Criteria:

* Other causes of heart failure other than diastolic dysfunction, such as restrictive cardiomyopathy or infiltrative cardiomyopathy
* Women who are pregnant or nursing
* Liver cirrhosis,
* Primary valvular disease
* Acute coronary syndrome
* Causes of PH other than that of heart failure, such as: chronic thromboembolic PH, sickle-cell disease, or sarcoidosis
* Severe bradycardia or greater than 1st degree heart block
* Decompensated heart failure
* Current use of a third generation beta-blocker (nebivolol, carvedilol, or labetalol) or high dose of any beta-blockers (greater than 100 mg daily of metoprolol, or equivalent)

Primary outcomes:
measure: Changes in Pulmonary Vascular Pressure
timeFrame: baseline - 18 weeks
Secondary outcomes:
measure: Changes in 6-minute Walk Distance
timeFrame: baseline - 18 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Julio Duarte, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06291246: Expediting Access to Services for Equity
Official title: Expediting Enrollment Into Autism-specific Intervention for Black Toddlers: A Telehealth-based Family Navigation Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-03-04
Enrollment: 86
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for Black toddlers under the age of 4 after their initial diagnosis of autism.

The main questions it aims to answer are:

Does Family Navigation decrease the time to initiation of intervention for Black toddlers with autism?

Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism?

Does Family Navigation improve caregiver well-being?

Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.

Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care.


Eligibility criteria: Inclusion Criteria:

* Children up to 48 months who have a new diagnosis of autism, or who are waiting for a diagnosis of autism AND their caregiver.
* Live in Georgia or North Carolina
* Caregiver must be over the age of 18
* Their child with autism must identify as Black/African-American
* Speak conversationally fluent English.

Exclusion Criteria:

* No access to a telephone or internet connection for phone calls or video conferencing.
* Diagnosis of autism spectrum disorder is ruled out in the child.

Primary outcomes:
measure: Time to initiation of autism specific intervention
timeFrame: From enrollment to 6 months post.
Secondary outcomes:
measure: Caregiver Well-Being Score
timeFrame: 6 months post enrollment
measure: Child's Developmental Functioning Score
timeFrame: 18 months post enrollment
measure: Child's Adaptive Functioning Score
timeFrame: 18 months post enrollment
measure: Appropriateness of Intervention Score
timeFrame: 6 months after enrollment
measure: Feasibility of Intervention Score
timeFrame: 6 months after enrollment
measure: Acceptability of Intervention Score
timeFrame: 6 months after enrollment
Other outcomes:
Locations:
city: Carrboro
country: United States
facility: Carolina Institute for Developmental Disabilities
state: North Carolina
Study officials:
affiliation: UNC
name: Kelly Caravella, PhD
role: PRINCIPAL_INVESTIGATOR
References: