louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02892552: Cone Beam CT Versus Multislice CT in the Postoperative Assessment of Cochlear Implantation
Official title: Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Implants
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Objective: To evaluate the diagnostic concordance between multislice computed tomography (MSCT) and cone beam computed tomography (CBCT) in the early postoperative assessment of patients after cochlear implantation.

Study Design: Prospective, randomized, single-center, interventional, pilot study on the diagnostic performance of a medical device.

Setting: Tertiary referral center. Patients: Patients aged over 18 years requiring a CT scan after cochlear implant surgery.

Interventions: Nine patients were implanted with electrode arrays from three different manufacturers, including one bilateral. High-resolution MSCT and CBCT were then performed, and 2 experienced radiologists blinded to the imaging modality evaluated the randomized images, twice.


Eligibility criteria: Inclusion Criteria:

* CI surgery for severe to profound bilateral deafness
* affiliated with the French health insurance

Exclusion Criteria:

* pregnancy
* Patients weighing more than 160 kg

Primary outcomes:
measure: Concordance between MDCT and CBCT for assessing the scalar position of the electrodes
timeFrame: At inclusion
Secondary outcomes:
measure: length of the intracochlear electrode array
timeFrame: At inclusion
measure: percentage of implanted cochlea
timeFrame: At inclusion
measure: number of intracochlear electrodes
timeFrame: At inclusion
measure: radiation dose
timeFrame: At inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service imagerie pavillon B, Hopital E. Herriot
Study officials:
References:
citation: Razafindranaly V, Truy E, Pialat JB, Martinon A, Bourhis M, Boublay N, Faure F, Ltaief-Boudrigua A. Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation. Otol Neurotol. 2016 Oct;37(9):1246-54. doi: 10.1097/MAO.0000000000001165.
Clinical trial NCT05586152: Study of INV-102 Ophthalmic Solution in Adults With Moderate Symptomatic Dry Eye Disease
Official title: Phase 1/2, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Multiple Ascending Dose (Part 1) and Optional Dose Expansion (Part 2) Study of INV-102 Ophthalmic Solution in Adult Subjects With Moderate Symptomatic Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dry Eye Disease
Keywords: Dry Eye
Keratoconjunctivitis sicca
Lead sponsor: Invirsa, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2022-10-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 1/2, first-in-human, 2-part study to assess topically administered eyedrops of INV-102 during 2-week repeat dosing in subjects with moderate symptomatic dry eye disease. Part 1 will be a Dose Escalation phase across 4 cohorts of subjects to assess safety and tolerability of INV-102, and Part 2 will be an Optional Dose Expansion phase in a fifth cohort of subjects, pending the outcome of Part 1, to assess efficacy of INV-102 in the treatment of moderate symptomatic dry eye disease.


Eligibility criteria: Key Inclusion Criteria:

* Healthy male or female subject ≥18 years of age
* Presence of moderate DED in at least one eye

Key Exclusion Criteria:

* Presently using prescription eyedrops, except those used for DED, which must be discontinued 2 weeks prior
* Use of OTC eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
* External eye disease except primary DED
* Systemic disease associated with DED
* History or evidence of ocular infection within the previous 30 days
* History or evidence of ocular herpes simplex or ocular herpes zoster
* Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months

Primary outcomes:
measure: Part 1: Characterize the safety profile of INV-102
timeFrame: Through study completion (Day 22)
measure: Part 2: Evaluate the efficacy of INV-102 in an expanded cohort
timeFrame: Day 15
Secondary outcomes:
measure: Part 2: Evaluate the efficacy of INV-102 using signs and symptoms in a combined outcome score
timeFrame: Day 15
Other outcomes:
Locations:
city: Rush
country: United States
facility: iuvo BioScience
state: New York
Study officials:
affiliation: Invirsa, Inc.
name: Robert Shalwitz, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02156752: Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-06-05
Enrollment: 190
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is a randomized controlled trial to compare the efficacy of two interventions- one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)- and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. All participants will first participate in an initial 4-month standard behavioral weight loss program. Participants will be randomized into 1 of 3 groups and receive a 3-part workshop; the ACT workshop will teach ACT skills including acceptance and mindfulness techniques designed to promote behavior change and health behavior persistence consistent with one's core values. The SR program will focus on self-regulation, regular weighing, and modeling behavior on successful maintainers. The WLO group will receive a control workshop focused on cooking demonstrations and general nutrition topics.The primary outcome is weight loss at 24 months. The secondary outcome is change in psychological flexibility, a critical component of ACT interventions and a potential innovative mediating mechanism. Primary Hypothesis: At 24 months, the ACT group will show significantly greater weight loss as compared to the SR and WLO groups.


Eligibility criteria: Inclusion Criteria:

* BMI 27.5-40
* Age 30-65

Exclusion Criteria:

* currently participating in a weight loss program
* pregnant or planning to become pregnant
* medical condition that would preclude physical activity
* terminal illness
* plans to relocate
* history of substance abuse or psychological problems that are judged by the investigators to be likely to interfere with study participation

Primary outcomes:
measure: Weight
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
affiliation: Lifespan/ The Miriam Hospital
name: Jason Lillis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lillis J, Dunsiger S, Thomas JG, Ross KM, Wing RR. Novel behavioral interventions to improve long-term weight loss: A randomized trial of acceptance and commitment therapy or self-regulation for weight loss maintenance. J Behav Med. 2021 Aug;44(4):527-540. doi: 10.1007/s10865-021-00215-z. Epub 2021 Mar 27.
citation: Lillis J, Thomas JG, Levin ME, Wing RR. Self-stigma and weight loss: The impact of fear of being stigmatized. J Health Psychol. 2020 Jun;25(7):922-930. doi: 10.1177/1359105317739101. Epub 2017 Nov 6.
Clinical trial NCT02199652: Reducing Suicidal Ideation Through Treatment of Nightmares-Post Traumatic Stress Disorder (PTSD)
Official title: Reducing Suicidal Ideation Through Treatment of Nightmares-PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Traumatic Stress Disorder
Suicidal Ideation
Nightmares
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with PTSD, and frequent nightmares, and mild-moderate suicidal ideation, who are already taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) will be randomized to either prazosin or placebo. The investigators hypothesize that patients receiving prazosin will have a greater reduction in suicidal ideation.


Eligibility criteria: Inclusion Criteria:

* PTSD
* Frequent nightmares
* Suicidality

Exclusion Criteria:

* Schizophrenia
* Bipolar
* Substance abuse

Primary outcomes:
measure: Change Score for Scale for Suicide Ideation
timeFrame: change score from baseline to last observation, up to 8 weeks
Secondary outcomes:
measure: Disturbing Dreams and Nightmare Severity Index
timeFrame: 8 weeks
measure: Insomnia Severity Index
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
Study officials:
affiliation: Augusta University
name: William V McCall, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04907552: Forensic Dental Age Estimation : Validation of Computed Tomography for Third Molar Demirjian's Staging
Official title: Forensic Dental Age Estimation : Validation of Computed Tomography for Third Mandibular Molar Demirjian's Staging Method in a 0- 25 Years French Living Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mandible Fracture
Keywords: Dental age estimation
CT scan
dental panoramic
Validation CT scan
Radiography
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 557
Sex: ALL
Minimum age (years): 0
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient aged between 0 and 25 years old

Brief summary: Age can be estimated in different ways by using skeletal age and dental age. Currently, bone age is determine thanks to the wrist x-rayed, and the dental age using variation in mineralization (Demirjian's score) on the dental panoramic (Mincer 1993).

More recently, reviews indicate the Computed tomography (CT) scan of the medial clavicular epiphysics can contribute to improve the accuracy of individual's age estimation (Houpert, 2016).

Furthermore, with the recent advances, the very low dose CT scan acquisitions can be perform with sufficient quality for the teeth analysis.

The goal of this study is to validate the use of dental CT for Demirjdian's staging method.


Eligibility criteria: Inclusion criteria:

* Patient aged between 0 and 25 years old
* Complete dental panoramic
* CT scan including mandible and maxilla
* Maximum of 2 months between CT scan and dental panoramic
* Medical imaging available on the PACS

Exclusion criteria:

* Medical imaging missing on the PACS
* Patient refuses to participate

Primary outcomes:
measure: weighted Kappa test between CT scan
timeFrame: day 1
Secondary outcomes:
measure: Mineralization difference
timeFrame: day 1
measure: Dental age estimation in a south french population
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Catherine CYTEVAL, MD.PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04076852: Gilles de la Tourette Syndrome (TS) and Seasonality
Official title: Gilles de la Tourette Syndrome (TS) and Seasonality: a Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tourette Syndrome
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 39
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Being a pilot study it was not possible to develop a sample study, but the sample number is designed based on the tourette center turnout

Brief summary: This retrospective and prospective observational study intends to evaluate the correlation between seasons and the variation of the syndromic structure of the Tourette.


Eligibility criteria: Inclusion Criteria:

* Patients attending the Tourette Center since January 2012.
* Males and females.
* Age between 6 and 50 (completed).
* Diagnosis of Tourette syndrome ascertained
* Presence of a value equal to or greater than 15/40 of the Y-BOCS.

Exclusion Criteria:

* Presence of allergic pathology.
* Presence of significant psychiatric symptoms, with the exception of those belonging to the Tourette Syndrome itself (eg ADHD, OCD)

Primary outcomes:
measure: Change from baseline Y-GTSS score at 6 months.
timeFrame: 4, 8, 12 months.
Secondary outcomes:
measure: Change from baseline Y-BOCS score at 6 months.
timeFrame: 4, 8, 12 months.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Galeazzi Hospital
state: Lombardy
Study officials:
affiliation: IRCCS Orthopedic Institute Galeazzi
name: Mauro Porta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04641052: The Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure
Official title: Effects of Music Intervention on Pain, Anxiety and Vital Signs in Patients With Endoscopic Retrograde Cholangiopancreatography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Retrograde Cholangio-Pancreatography
Anxiety
Pain
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 70
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: This study aims to investigate the effect of music listening on patients who will have Endoscopic Retrograde Cholangio-Pancreatography Procedure on vital signs, anxiety, and pain. This will be a randomized controlled experimental study.

The study will be conducted with two groups: the intervention group (n=35) and the control group (n=35). The control group will receive standard care while the intervention group, in addition to standard care, will be listened to music by the researchers for 15 minutes before the procedure.


Eligibility criteria: Inclusion Criteria:

* patients aged 18 or above,
* with a scheduled ERCP procedure
* with the ASA grade level of I-II clinically
* without a hearing/speech impairment
* willing to participate in the research
* without a mental problem or diagnosis of psychiatric disorder
* without any a diagnosis of depression

Exclusion Criteria:

* Patients with an emergency ERCP procedure
* with a hearing/speech impairment
* not willing to participate in the research
* with a mental problem or diagnosis of psychiatric disorder
* with a diagnosis of depression

Primary outcomes:
measure: Visual Analog Scale for Anxiety (VAS-A)
timeFrame: 1 Hour
measure: Visual Analog Scale for Pain (VAS)
timeFrame: 2 Hours
Secondary outcomes:
measure: Vital Signs
timeFrame: 4 Hours
measure: Vital Signs
timeFrame: 4 hours
measure: Vital Signs
timeFrame: 4 hours
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences university Hospital
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Yeliz CIGERCI, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06801652: The Influence of Sperm Morphology and Functional Indices on Blastocyst Development in Assisted Reproduction
Official title: The Influence of Sperm Morphology and Functional Indices on Blastocyst Development in Assisted Reproduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spermatozoa, Abnormal
in Vitro Fertilization
Blastocyst
Aneuploidy
Lead sponsor: Calla IVF Center
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective observational study analyzed sperm and embryonic parameters from 120 IVF cycles over 18 months. Functional sperm indices and embryo outcomes were evaluated to determine their relationship.

Brief summary: Samples from male partners of 120 infertile couples undergoing IVF were analyzed. Sperm morphology was assessed using the SpermBlue staining method, while TZI, MAI, and SDI were calculated. Embryo development was monitored until day 5 or 6. Statistical analyses included regression models and correlation coefficients to evaluate the predictive value of sperm indices on blastocyst development.

Detailed description: For spermatozoa selection we used ZyMot multi in all patients undergoing IVF. After intracytoplasmatic injection of spermatozoa we asses the blastocyst grading in day 5. NEQSI score meaning numerical embryonic quality score index was used for statistical purpose. The spermatozoa morphology indexes were: TZI (teratozoospermia index), MAI (multiple anomalies index), SDI (sperm deformity index) and analyzed with CASA analyzer. All these indexes were assessed in patients and correlated in all groups: patients that had a positive pregnancy test, patients that had a negative pregnancy rate, patients that had no blastocyst in day 5 and patients that had all aneuploid embyos.

Eligibility criteria: Inclusion Criteria:

* couples with an infertility diagnosis that underwent an IVF procedure and had obtained at least one blastocyst

Exclusion Criteria:

* donors
* uterine abnormalities

Primary outcomes:
measure: Evaluation of sperm morphology indices on fertilization and blastulation rate
timeFrame: 18 months
Secondary outcomes:
measure: Evaluation of sperm morphology indices on IVF outcomes
timeFrame: 16 months
Other outcomes:
Locations:
city: Oradea
country: Romania
facility: Calla Ivf Center
state: Bihor
Study officials:
References:
Clinical trial NCT04050852: Pulmonary Function Test Changes and Respiratory Muscle Strength Trends in Spinal Muscular Atrophy Patients Receiving Nusinersen Treatments
Official title: Pulmonary Function Test Changes and Respiratory Muscle Strength Trends in Spinal Muscular Atrophy Patients Receiving Nusinersen Treatments
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Spinal Muscular Atrophy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Winthrop University Hospital
First posted: 2019-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 5-10 patients with spinal muscular atrophy (SMA), ages 5 years old and above, who have already consented to nusinersen treatment, or have already initiated nusinersen (spinraza) treatments at NYU Winthrop Hospital.
Primary purpose: TREATMENT

Brief summary: It is well known that patients with spinal muscular atrophy (SMA) have progressive decline of respiratory muscle function. Therapy traditionally involved supportive means to ensure optimal nutrition and airway clearance. Nusinersen (spinraza) is a disease-modifying medication approved for treatment of SMA in pediatric and adult patients. The goal of this study is to observe pulmonary function test (PFT) changes and respiratory muscle strength trends throughout the first year of treatment. A prospective, longitudinal study measuring pulmonary function testing (PFTs) changes in spinal muscular atrophy (SMA) patients. Patients will be patients with SMA who are approved and maintained on nusinersen. Patient will have a baseline PFT. Investigators will repeat PFT at 3, 6, and 12 months while on nusinersen treatment.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with SMA of any type who are eligible to start nusinersen treatments at NYU Winthrop Hospital.

Exclusion Criteria:

* Patients unable to comply with nusinersen treatments according to recommended schedule (first 3 doses every 2 weeks, then the 4th dose is administered 1 month after the 3rd dose, and then maintenance dose administered every 4 months).

Primary outcomes:
measure: percent improvement Maximum inspiratory pressure (MIP)
timeFrame: 3, 6, and 12 months
measure: percent improvement Maximum expiratory pressure (/MEP)
timeFrame: 3, 6, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Melodi Pirzada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03966352: Pathways to Fatherhood
Official title: Family Building Decisions for Gay Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Family Research
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gay men who sought or are currently seeking family building services at an infertility practice through third party reproduction

Brief summary: The purpose of this study is to better understand the decision-making process that gay couples go through in order to have children.

Detailed description: The purpose of this study is to better understand treatment considerations, obstacles, motivations, and outcomes for gay men through a survey based questionnaire study.

Eligibility criteria: Inclusion Criteria:

* Men over age 18 who self-identify as gay
* Participants should be individuals who are seeking or have sought reproductive services at RMA New Jersey locations.
* Participants may be included if they have not yet gone through the assisted reproductive process but are considering fatherhood and identify as gay.

Exclusion Criteria:

* Individuals who are not 18 years of age or older.
* Participants who do not self-identify as gay males.
* Female patients.
* Failure of the participant to agree to enrollment in the study with written consent.

Primary outcomes:
measure: Response to survey questions
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
References: