louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06108167: Percutaneous Imaging-guided Cryoblation of the Anterior Abdominal Wall Endometriosis Scars
Official title: Percutaneous Imaging-guided Cryoblation of the Anterior Abdominal Wall Endometriosis Scars
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Keywords: Endometriosis
Endometrial cells
Radiofrequency
Anterior abdominal
Cryotherapy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 29
Sex: FEMALE
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: Adult woman (≥18 years old) Having benefited from cryotherapy of an abdominal wall endometriosis nodule between January 6, 2020 and January 2, 2023.

Brief summary: Endometriosis is a common condition affecting 10% of women. It is characterized by the presence of ectopic endometrial cells. This pathology most frequently develops in the ovaries, utero-sacral ligaments and pelvic peritoneum, but also in the recto-sigmoid. Rarely, these lesions are found outside the pelvis, and even more exceptionally in the abdominal wall (in 0.03 to 1% of cases).

Cryotherapy has already been used for many years to treat soft tissue tumors (kidney and prostate tumors). It has also been successfully used by interventional radiologists to treat parietal desmoid tumors. After discussions with radiologists, given the similarity of location and extension of wall endometriosis lesions with desmoid tumours, the successes observed, and the scarcity of studies in the literature, it seemed appropriate to the investigators to study this new therapy.

The aim of this study was to investigate the efficacy of cryotherapy on parietal endometriosis lesions.


Eligibility criteria: Inclusion Criteria:

* Adult woman (≥18 years old) Having benefited from cryotherapy of an abdominal wall endometriosis nodule between January 6, 2020 and January 2, 2023.
* Subject not objecting to the reuse of their data for the purposes of this research

Exclusion Criteria:

* Subject having expressed its opposition to the reuse of its data for scientific research purposes.

Primary outcomes:
measure: Efficacy of cryotherapy on parietal endometriosis lesions was assessed using the a visual analogue scale (VAS) ranging from 0 to 10.
timeFrame: Before and 6 months after the cryotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologie Obstétrique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT04392167: a/LCI-OCT Pilot in Esophagus
Official title: Advanced Angle-Resolved Low Coherence Interferometry (a/LCI) Systems for Improved Clinical Utility: An a/LCI-Optical Coherence Tomography (OCT) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Esophagus
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of North Carolina, Chapel Hill
First posted: 2020-05-18
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will test a newly developed dual modality probe, including optical coherence tomography (OCT) and angle-resolved low-coherence interferometry (a/LCI), in the human esophagus to determine 1) whether adequate tissue contact can be attained by the probe to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium. This pilot study will test the operating characteristics of the probe and collect data for further optimization of the a/LCI-OCT device.


Eligibility criteria: Inclusion Criteria:

* Presenting to University of North Carolina (UNC) for routine care upper endoscopy
* Meet one of the following criteria:

  1. Current dysplastic or non-dysplastic Barrett's Esophagus of any length OR,
  2. History of dysplastic or non-dysplastic Barrett's Esophagus after treatment with endoscopic eradication therapy (EET) OR,
  3. Normal asymptomatic controls without any history of dysplastic Barrett's Esophagus
* Aged 18 to 80
* Able to read, comprehend, and understand the informed consent document

Exclusion Criteria:

* Prior esophageal surgery (uncomplicated nissen fundoplication OK)
* Pregnant women
* Unable to provide written informed consent

Primary outcomes:
measure: Percentage of Correctly Identified Positive (Dysplastic) Biopsies
timeFrame: day 1
measure: Percentage of Correctly Identified Negative (Non-Dysplastic) Biopsies
timeFrame: day 1
Secondary outcomes:
measure: Percentage of Participants With Adequate Tissue Contact to Acquire a High Quality Image
timeFrame: day 1
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: Professor
name: Adam Wax, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terry NG, Zhu Y, Rinehart MT, Brown WJ, Gebhart SC, Bright S, Carretta E, Ziefle CG, Panjehpour M, Galanko J, Madanick RD, Dellon ES, Trembath D, Bennett A, Goldblum JR, Overholt BF, Woosley JT, Shaheen NJ, Wax A. Detection of dysplasia in Barrett's esophagus with in vivo depth-resolved nuclear morphology measurements. Gastroenterology. 2011 Jan;140(1):42-50. doi: 10.1053/j.gastro.2010.09.008. Epub 2010 Sep 18.
Clinical trial NCT05625867: Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit
Official title: Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Intensive Care Syndrome
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 404
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: A patient's stay in the ICU is not without consequences and can cause various physical and/or psychological sequelae such as anxiety, depression, post-traumatic stress disorder (PTSD), physical weakness and memory problems. These sequelae are grouped under the name "post intensive care syndrome" or PICS.

Numerous studies have shown that PICS affects 50-70% of patients; however, very few studies have been conducted on the medical and psychological support devices needed for these patients following their hospitalization. Despite recommendations to set up an early and specific rehabilitation program, post-resuscitation consultations are not very frequent in France. The aim of the study is to measure the impact of an interdisciplinary post-resuscitation consultation on the quality of life of patients who have stayed more than 6 days in an intensive care unit.

All patients who agreed to participate will be followed for a period of 9 months after discharge from the ICU.

One month after discharge from the ICU, the patients will be randomly assigned to

* either in the "intervention" group who will benefit from an interdisciplinary post resuscitation consultation 4/5 months after their discharge from the intensive care unit
* or in the "control" group without post resuscitation consultation. They will all be contacted at 4/5 and 9 months to complete psychological and quality of life questionnaires.


Eligibility criteria: Inclusion Criteria:

* Person who has given oral consent
* Patient 18 years of age or older
* Patient with at least one organ failure
* Patient with a stay of 6 days or more

Exclusion Criteria:

* Person who is not affiliated or not a beneficiary of a social security system
* Patient at the end of his/her life
* Patient who does not speak French
* Minor (\< 18 years old)
* Person subject to a legal protection measure (curatorship, guardianship)
* Person subject to a legal protection measure
* Pregnant, parturient or breastfeeding women
* Patient incarcerated
* Patient with a psychiatric history

Primary outcomes:
measure: MOS SF-36 Quality of Life Scale Score
timeFrame: Between 4/5 and 9 months after discharge from intensive care
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT06122467: A Single Group Study to Evaluate the Efficacy of a Cosmetic Product Line on Acne Symptoms
Official title: A Single Group Study to Evaluate the Efficacy of a Cosmetic Product Line on Acne Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne
Lead sponsor: Menning Labs
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This twelve-week trial will examine the effectiveness of a Menning Labs EQ Product Line acne product. Participants will use the exfoliating cleanser, cream, and gel daily for 8 weeks. Participants will complete questionnaires at Baseline, Day 1, Day 3, Day 7, Day 28, Day 42, and Day 56. Participants will also provide before-and-after photos at Baseline, Day 7, and Day 42, as well as undergo expert skin grading at Baseline and Day 42. The questionnaire on Day 56 will mark the conclusion of the trial.


Eligibility criteria: Inclusion Criteria:

* Be aged between 18-45.
* Anyone who has acne prone skin and a history of recurring acne.
* Has visible acne at enrollment.
* Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
* Have a digital camera or smartphone to take photos of the face.

Exclusion Criteria:

* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Anyone currently using a prescription skin product.
* Anyone who is unwilling to stop using the current acne supplements they are taking.
* Anyone with known severe allergic reactions.
* Any women who are pregnant, breastfeeding or attempting to become pregnant.
* Anyone unwilling to follow the study protocol.
* Anyone who identifies as having sensitive skin.

Primary outcomes:
measure: Change in the appearance of facial skin acne. [Timeframe: Baseline to Day 56]
timeFrame: 56 days
measure: Changes in skin clarity i.e. reduction in acne or associated blemishes. [Timeframe: Baseline to Day 56]
timeFrame: 56 days
Secondary outcomes:
measure: Changes in overall skin health. [Timeframe: Baseline to Day 56]
timeFrame: 56 days
measure: Changes in skin texture. [Timeframe: Baseline to Day 56]
timeFrame: 56 days
measure: Changes in facial skin irritation. [Timeframe: Baseline to Day 56]
timeFrame: 56 days
measure: Changes in skin redness. [Timeframe: Baseline to Day 56]
timeFrame: 56 days
measure: Changes in skin smoothness. [Timeframe: Baseline to Day 56]
timeFrame: 56 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT04289467: Treatment of Refractory Infantile Spasms With Fenfluramine
Official title: A Phase II Study of Fenfluramine for Treatment of Refractory Infantile Spasms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Infantile Spasm
Lead sponsor: Children's Hospital of Orange County
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II clinical trial in which children with refractory infantile spasms (also called epileptic spasms or West syndrome) will be treated with fenfluramine, to evaluate efficacy, safety, and tolerability. Patients with infantile spasms that have not responded to treatment with vigabatrin and ACTH we will be invited to participate. Study participants will undergo baseline video-EEG, receive treatment with fenfluramine for 21 days, and then undergo repeat video-EEG to determine effectiveness. Patients with favorable response will have the opportunity to continue treatment for up to 6 months.


Eligibility criteria: Inclusion Criteria:

* Children ages 12 to 36 months, inclusive
* Clinical diagnosis of infantile spasms
* Continued epileptic spasms despite adequate treatment with ACTH and vigabatrin.

Exclusion Criteria:

* Significant preexisting cardiovascular disease
* Exposure to any cannabinoid product within 14 days of screening
* Initiation or dose-titration of any second-line treatment for infantile spasms in the 14 days prior to screening.
* Implantation of a vagal nerve simulator within 14 days of screening
* Initiation and maintenance of the ketogenic diet within 3 months of screening

Primary outcomes:
measure: Electroclinical response (Efficacy)
timeFrame: 12 months
Secondary outcomes:
measure: Computational electroencephalography response (Efficacy)
timeFrame: 12 months
measure: Incidence of treatment emergent adverse events (Safety and tolerability)
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Health
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
Study officials:
affiliation: Children's Hospital of Orange County
name: Daniel Shrey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05270967: FDG (Fluorodeoxyglucose) Findings After COVID-19 Vaccination
Official title: Evaluation of Metabolic Changes in FDG PET/CT Imaging After mRNA-based COVID-19 Vaccination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccine Reaction
Oncology
Keywords: covid-19
vaccine
pet/ct
FDG
mRNA
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 129
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: recently vaccinated patients who underwent FDG PET/CT imaging between July 2021 and December 2021, were included in this prospective analysis

Brief summary: It is important to evaluate the vaccine-related metabolic changes on FDG PET/CT to avoid confusing results. The investigators aimed to assess the frequency and intensity of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine (BNT162b2-Pfizer/BioNTech) and to analyze possible factors affecting these changes.


Eligibility criteria: Inclusion Criteria:

* patients referred for post-vaccination FDG PET/CT imaging

Exclusion Criteria:

* Disseminated metastatic disease, ipsilateral breast cancer or lymphoma that was likely to involve axilla, and patients who had ipsilateral intense axillary uptake or thyroiditis on their prior imaging, were exclusion criteria

Primary outcomes:
measure: to assess the frequency of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine
timeFrame: 5 month
measure: to assess the FDG intensity of regional and systemic metabolic PET/CT changes of patients who received the mRNA-based COVID-19 vaccine
timeFrame: 5 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University School of Medicine Dep. of Nuclear Medicine
Study officials:
affiliation: Kocaeli University School of Medicine
name: Serkan Isgoren, Ass prof
role: STUDY_CHAIR
References:
citation: Cohen D, Krauthammer SH, Wolf I, Even-Sapir E. Hypermetabolic lymphadenopathy following administration of BNT162b2 mRNA Covid-19 vaccine: incidence assessed by [18F]FDG PET-CT and relevance to study interpretation. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1854-1863. doi: 10.1007/s00259-021-05314-2. Epub 2021 Mar 27.
Clinical trial NCT02283567: The Difference Between Elasticity of the Uterine Cervix in Singleton and Twin Pregnancies
Official title: The Difference Between Elasticity of the Uterine Cervix in Singleton and Twin Pregnancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20-44 years old pregnant patients

Brief summary: The investigators aim to compare elasticity of the uterine cervix in singleton and twin pregnancies of similar gestational age.

Detailed description: Softening of the uterine cervix occurs during pregnancy.There is a possibility that this process occurs earlier in twin versus singleton pregnancies.The softening of the cervix is reflected by the level of its elasticity which can be measured sonoelastographically. A two dimension image of the cervix is obtained in the midsagittal section and the length is noted. A 2nd sonoelastography image is obtained before pressure is applied with the transducer in the area of the internal os and a third sonoelastography image is obtained until no more shortening of the anterior-posterior diameter is observed.Elastography measurements of the internal os are performed using a color map: red (soft), yellow (medium soft), blue (medium hard) and purple (hard) before and after the application of strain.The change between the color maps before and after strain application in singleton pregnancies will be compared to the change in twin pregnancies of similar gestational age.

Eligibility criteria: Inclusion Criteria:

* Low risk singleton and twin pregnancies

Exclusion Criteria:

* Patients with pregnancy complications

Primary outcomes:
measure: Comparison of elasticity levels in singleton and twin pregnancies (Elastographic measurements of the internal os)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Meir Medical Center
name: Rami Aviram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02668367: Safety and Pharmacokinetics Study of Multiple Ascending Doses of BTA-C585 in Healthy Volunteers
Official title: A Sequential-Cohort, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study of the Safety and Pharmacokinetics of BTA-C585 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Healthy Volunteers
Keywords: Viral Diseases
Antiviral
Paramyxoviridae Infections
RSV
Respiratory Syncytial Virus
Aviragen Therapeutics, Inc.
Aviragen Therapeutics
Aviragen
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2016-01-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single center, sequential-cohort, double-blind, placebo-controlled, multiple ascending dose (MAD), 7-day treatment period study in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy men and women;
2. Age 18 to 60 years, inclusive;
3. Weight ≥ 50 kg and Body Mass Index (BMI) of 19 to 32, inclusive;
4. Female subjects must be of non-childbearing potential;
5. Male subjects must agree to use a double barrier method of birth control;
6. Signed informed consent form (ICF) prior to study procedures.

Exclusion Criteria:

1. Current or recent (within 14 days of Day 0) bacterial or viral infection;
2. Positive results at screening for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody;
3. Clinically significant abnormalities noted on ECG;
4. Safety laboratory abnormalities;
5. Regular use of medications, prescription or non-prescription;
6. Poor vein access or fear of venipuncture or sight of blood;
7. Major surgery, significant recent injury or trauma within 30 days;
8. Received an investigational drug or vaccine within 30 days.

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours
timeFrame: 0-24 hours
measure: Number of adverse events
timeFrame: Day -1 to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Biota Investigational Site
state: Texas
Study officials:
affiliation: Biota Pharmaceuticals, Inc.
name: Anna Novotney-Barry
role: STUDY_DIRECTOR
References:
Clinical trial NCT02751567: 18776 - Human Photoallergy Test
Official title: Human Photoallergy Test
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the potential of a test material to produce a photoallergic response.


Eligibility criteria: Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products.
* subjects who are employees of the CRO and/or Bayer or is a household member of an employee

Primary outcomes:
measure: Intensity of skin reactions is evaluated by 5 point scale
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03099967: Cardiac Troponin T After Transcatheter Closure of the Interatrial Septum
Official title: Cardiac Troponin T After Transcatheter Closure of the Interatrial Septum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 51
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: Fifty one patients who underwent transcatheter ASD and PFO closure (the University Hospital of Lund, Sweden) were studied retrospectively.

Brief summary: To examine retrospectively whether transcatheter closure of the interatrial septum leads to myocardial injury and to determine the mechanism.

Detailed description: In a prospective study in adults troponin T (TnT) serum concentrations were determined before and the day after transcatheter closure of an atrial septal defect (ASD) or patent foramen ovale (PFO).

Eligibility criteria: Inclusion Criteria:

* transcatheter ASD and PFO closure at the University Hospital of Lund, Sweden

Exclusion Criteria:

* missing TnT values

Primary outcomes:
measure: TnT changes
timeFrame: Blood samples for TnT were taken one day before intervention and one day after intervention.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: