louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02356822: Sarah Cannon Outcomes Registry
Official title: Sarah Cannon Outcomes Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Oncology
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18yrs or older, that have been diagnosed with/ or are thought to have any form of cancer at any stage in the continuum of their care from screening through survivorship. Patient must have the ability to understand the nature of the trial and give written informed consent.

Brief summary: This is an investigational multi-site outcomes registry intended to collect information about a patient's cancer care. Patients may enter the Registry at any time during the patient's current stage in the continuum of care. The registries main objectives will be to measure and evaluate the effects of patient care throughout the care continuum, resulting in the identification of the most effective treatment options. Objectives will encompass evaluations and analytics around safety, effectiveness, and improved efficiencies.

Detailed description: Q

Eligibility criteria: Inclusion Criteria:

* 18 or older
* Patients that have been diagnosed with/ or are thought to have any form of cancer at any stage in the continuum of their care from screening through survivorship.
* Patient must have the ability to understand the nature of the trial and give written informed consent

Exclusion Criteria:

* There are no exclusion criteria for this Outcomes Registry

Primary outcomes:
measure: quality improvement
timeFrame: 10 yrs
measure: Treatment patterns and utilization
timeFrame: 5 yrs
Secondary outcomes:
measure: Humanistic and economic outcomes
timeFrame: 10 yrs
Other outcomes:
measure: safety and effectiveness
timeFrame: 10 yrs
Locations:
city: Nashville
country: United States
facility: SCRI
state: Tennessee
Study officials:
affiliation: Sarah Cannon
name: Richard Geer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05452122: Decoding and Selective Modulation of Human Memory During Awake/Sleep Cycles
Official title: Decoding and Selective Modulation of Human Memory During Awake/Sleep Cycles
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Memory, Delayed
Keywords: sleep
stimulation
memory
learning
single-unit
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2022-07-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed project seeks to elucidate memory processes and consolidation during sleep by leveraging the unique capability of direct recordings from the human brain at multiple levels of resolution-single neurons, localized neuronal assemblies, intracranial local field potentials-during rich behavioral tasks with real-life narratives and extracting neural features that relate to different aspects of episodic experience. The investigators will further probe causal mechanisms of consolidation by application of auditory and electrical stimulations during sleep and its effect on modulating memory processes.


Eligibility criteria: Inclusion Criteria:

* All epilepsy patients between the ages of 18 and 65 who undergo depth electrode placement for clinical purposes
* Eligibility is determined by the epilepsy surgery team (based on neuropsychological testing and on psychiatric evaluation)
* Willing to provide informed consent and participate the study

Exclusion Criteria:

* Neurological or psychiatric issues, other than epilepsy, that would put the patient at risk
* Patient is younger than 18 or older than 65 years of age
* Unwilling to provide informed consent

Primary outcomes:
measure: Recognition Accuracy
timeFrame: 1-2 days contained within the participants' 1-2 week hospital stay; Specifically for each experiment, the outcome measure will be computed during the pre- and post-sleep memory tasks
measure: Recognition Discriminability (D-prime)
timeFrame: 1-2 days contained within the participants' 1-2 week hospital stay; Specifically for each experiment, the outcome measure will be computed during the pre- and post-sleep memory tasks.
Secondary outcomes:
measure: Power sleep oscillations
timeFrame: 1-2 days contained within the participants' 1-2 week hospital stay. Specifically for each experiment, the outcome measure will be computed during the sleep period between pre and post-sleep memory tasks.
measure: Neuronal replay index
timeFrame: 1-2 days contained within the participants' 1-2 week hospital stay. Specifically for each experiment, the outcome measure will be computed during the sleep period between pre and post-sleep memory tasks.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
References:
Clinical trial NCT04400422: Experience of Using Lipano in Children With Fatty Acid Oxidation Disorders
Official title: Experience of Using Lipano in Children With LCHAD (Long Chain Fatty Acid Oxidation Disorder)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Acid Oxidation Disorder
Lead sponsor: Dr. Schär AG / SPA
Sponsor class: INDUSTRY
First posted: 2020-05-22
Enrollment: 5
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a market research, observational study to evaluate the tolerability and acceptability of an MCT based formula for infants and young people with long chain fatty acid oxidation disorder from birth to 18 months. Patients with a confirmed diagnosis of a fatty acid oxidation disorder, which requires a specialist diet including MCT will be included in this study


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a fatty acid oxidation disorder requiring a ketogenic or a specialist diet as part of their treatment, which includes MCT.
* Patients from birth to 18 months
* Written informed consent obtained from patient or parental caregiver

Exclusion Criteria:

* Presence of serious concurrent illness
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
* Any patients having taken antibiotics over the previous 2 weeks leading up to the study
* Patients over 18 months of age

Primary outcomes:
measure: Gastrointestinal tolerance: questionnaire
timeFrame: 90 days
measure: Product compliance
timeFrame: 90 days
measure: Product palatability
timeFrame: 90 days
measure: Product acceptability
timeFrame: 90 days
Secondary outcomes:
measure: Biochemistry stability - creatine kinase
timeFrame: 90 days
measure: Biochemistry stability - liver enzymes
timeFrame: 90 days
measure: Anthropometry 1
timeFrame: 90 days
measure: Anthropometry 2
timeFrame: 90 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian Children's Hospital Center for Orphan Diseases
Study officials:
References:
Clinical trial NCT04685122: Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability
Official title: Study of Subluxation Lens Biometrics and Postoperative Intraocular Lens Stability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subluxation of Lens
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People whose subluxation of the lens is less than 180 degrees

Brief summary: To compare the accuracy of four lens diameter measurement methods and to study the influencing factors of intraocular lens deviation after operation


Eligibility criteria: Inclusion Criteria:

(1) Subluxation of the lens is less than 180 degrees; (2) Part of the edge of the lens can be seen in the pupil area after the pupil is dilated

Exclusion Criteria:

(1) Total dislocation of the lens to the vitreous cavity (2) Patients with small eyeballs and small eyelid fissures (3) Patients younger than 18 years old (4) Congenital cataracts in both eyes (5) Corneal dystrophy or endothelial cell insufficiency (6) Chronic uvea Inflammation (7) Progressive fundus disease (8) Fragile capsular bag (9) Retinitis pigmentosa or pseudocapsular exfoliation syndrome

Primary outcomes:
measure: Lens diameter
timeFrame: through study completion, an average of 1 year
measure: The eccentric distance of the intraocular lens
timeFrame: 1 week postoperation
measure: The eccentric distance of the intraocular lens
timeFrame: 1 month postoperation
measure: The eccentric distance of the intraocular lens
timeFrame: 3 month postoperation
measure: The tilt angle of the intraocular lens
timeFrame: 1 week postoperation
measure: The tilt angle of the intraocular lens
timeFrame: 1 month postoperation
measure: The tilt angle of the intraocular lens
timeFrame: 3 month postoperation
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT00518622: Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)
Official title: A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of MK7009 in Hepatitis C Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C


Eligibility criteria: Inclusion Criteria:

* Subject is a man or a woman aged 18 to 55 years of age.
* Subject has chronic Hepatitis C
* Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period

Exclusion Criteria:

* Patient has evidence of advanced liver disease.
* Patient has human immunodeficiency virus (HIV)
* Patient has Hepatitis B

Primary outcomes:
measure: Safety and Tolerability of MK7009
timeFrame: 14 days after completion of study therapy
measure: Antiviral Activity of MK7009
timeFrame: Baseline and Day 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.
Clinical trial NCT04616222: A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels
Official title: A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transposition of Great Vessels
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paediatric patients with an arterial switch operation for transposition of the great vessels

Brief summary: Celsior® is an organ preservation solution used for the harvesting and the preservation of solid organs. Its use as a crystalloid cardioplegia solution has been established recently. Its main advantage is the long duration of myocardial protection. Compared to the other cardioplegia solutions, it allows a reduced amount of solution administered during the surgery and fewer interruptions during the intervention for the administration of supplemental doses of cardioplegia for long and complex operations.

The objective of this register is to compare the safety and the efficacy of Celsior® to the old cardioplegia solution Saint-Thomas used as cardioplegia solution in surgery of the transposition of great vessels, the arterial switch operation.


Eligibility criteria: Inclusion Criteria:

* Patient of neonatal age at the time of the intervention
* Patients with a transposition of the great vessels with intact septum and with the arterial switch operation performed as a corrective procedure
* CELSIOR® used as cardioplegia solution between 2012 and 2019
* Saint-Thomas used as cardioplegia solution (control group) between 2005 and 2011

Exclusion Criteria:

* Major cardiovascular malformations needing correction during the surgery for the transposition of great vessels including : interventricular communication, coarctation of the aorta, interruption of the aortic arch
* Significant anomalies of coronary arteries origin or paths including : intramural course, single coronary ostium
* Opposition to participate in this retrospective research

Primary outcomes:
measure: Death at 30 days after surgery
timeFrame: 30 days
Secondary outcomes:
measure: Post-operative troponin levels
timeFrame: 48 hours
measure: Cardiac rhythm assessment
timeFrame: 24 hours
measure: Variation of pre- and post-operative creatinine levels
timeFrame: 24 hours
measure: Intensive care unit length of stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Bron
country: France
facility: : Hôpital Louis Pradel - Service de Chirurgie Cardiaque C
Study officials:
References:
Clinical trial NCT01357122: Evaluating Results of Neusidl Corneal Inserter in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
Official title: A Randomized, Observer-masked, Clinical Trial Comparing the Neusidl Corneal Inserter Corneal Transplant Technique to the Standard Forceps Insertion Technique for Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fuchs' Corneal Endothelial Dystrophy
Lead sponsor: Legacy Health System
Sponsor class: OTHER
Collaborators: name: Devers Eye Institute
name: Lions Eye Bank of Oregon Vision Research Laboratory
name: Fischer Surgical, Inc.
First posted: 2011-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project compares the Neusidl Corneal Injector (NCI) device developed by Fischer Surgical, Inc. for the delivery of tissue into the eye in DSAEK surgery to the current standard forceps insertion DSAEK technique. The goal of this study is to examine the damage to the corneal endothelium resulting from the use of the NCI device in comparison to the use of our standard surgical DSAEK technique over time.


Eligibility criteria: Inclusion Criteria:

* Age 21 and over
* A diagnosis of Fuchs' Corneal Endothelial Dystrophy

Exclusion Criteria:

* Under age 21
* Diagnosis of advanced glaucomatous disease
* Diagnosis of significant retinal disease
* Diagnosis of any other corneal dystrophy
* Previous corneal transplant surgery
* Previous glaucoma surgery
* Previous retinal surgery
* Previous refractive surgery

Primary outcomes:
measure: Decrease in Endothelial Cell Density From Baseline Over Time
timeFrame: 6, 12, 24, and 60 Months
Secondary outcomes:
measure: Adverse events
timeFrame: Any time during follow-up period (5 years)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
Study officials:
affiliation: Devers Eye Institute
name: Mark A Terry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04440722: Prospective Observational Study and Biobank CKIO
Official title: Prospective Observational Study and Biobank in All Persons Referred to Center of Gender Identity Odense University Hospital (CKIO)/Body Identity Clinic
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Transgender
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 100
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: All patients referred til CKIO

Brief summary: Prospective observational study and biobank in all persons referred to CKIO

* Patient involvement and quality of life
* Population characteristics regarding hormone levels, safety parameters and clinical outcome before and after gender affirming hormone treatment.

Detailed description: This is a prospective observational cohort study including all patients referred to the Center of Gender Identity Odense. The purpose is to follow patients yearly to observe patient reported outcomes and control the quality and effects of the clinical treatment.

Eligibility criteria: Inclusion Criteria:

* All Individuals with gender dysforia who are referred to Center of Gender Identity Odense
* Age 18+

Exclusion Criteria:

°There are no exclusion criteria

Primary outcomes:
measure: Patient reported outcomes (PRO)
timeFrame: Every 52 weeks
measure: Hormone levels
timeFrame: Every 52 weeks
measure: Safety parameters
timeFrame: Every 52 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: Every 52 weeks
measure: Body mass index
timeFrame: Every 52 weeks
measure: Body weight
timeFrame: Every 52 weeks
measure: Hair cortisol
timeFrame: Every 52 weeks
measure: Cortisol metabolism
timeFrame: Every 52 weeks
measure: Spirometry
timeFrame: Every 52 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology, Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Marianne Andersen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03863522: Automated Method for Breast Cancer Detection
Official title: Automated Method for Breast Cancer Detection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer Diagnosis
Keywords: Breast Cancer Diagnosis
Ultrasound-guided core needle biopsy
Fine needle aspiration
FNA
Diagnostic Cartridge
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Participants with suspicious breast lesions by mammography will undergo fine needle aspiration (FNA) under ultrasound guidance. The FNA will be read by the cytopathologist and analyzed in the breast cancer detection cartridge. All patients will receive standard of care (Ultrasound-guided core needle biopsy and diagnosis). We will also receive FNA collected from 60 patients with palpable lesions in South Africa and analyze them samples in our lab with the same method.


Eligibility criteria: Inclusion Criteria:

* Patient must be female
* Patient must be 18 years of age or older
* Patient has been recommended for ultrasound core needle biopsy of a suspicious breast lesion

Exclusion Criteria:

* Patients may be excluded for any condition that in the opinion of the investigator may not make it safe to take part (e.g. certain medicines).

Primary outcomes:
measure: Correlation of Diagnostic Cartridge With Histopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Core Biopsy or Resected Lesion
timeFrame: up to 2 years
measure: Correlation of Diagnostic Cartridge With Cytopathology as Assessed by Number of Participants With Same Diagnosis From Both Cancer Detection Cartridge and Cytology of Fine Needle Aspiration (FNA)
timeFrame: up to 2 years
Secondary outcomes:
measure: Correlation of Diagnostic Cartridge With Known Lab Assay
timeFrame: up to 2 years
measure: Correlation of Known Lab Assay for FNA Versus the Core Biopsy
timeFrame: up to 2 years
measure: Correlation of Cartridge Based Quantitative Evaluation of Tumor Markers (ER/PR/Her2 and Ki67) in FNA Versus FFPE Sections
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital Outpatient Center
state: Maryland
city: Lutherville-Timonium
country: United States
facility: Johns Hopkins Medical Imaging at Green spring Station
state: Maryland
Study officials:
affiliation: JHU School of Medicine
name: Lisa Mullen, MD
role: PRINCIPAL_INVESTIGATOR
References: