louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01459731: Optical Coherence Tomography (OCT) Data Collection Study
Official title: Optical Coherence Tomography Data Collection Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: No Eye Disease
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2011-10-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No eye disease

Brief summary: Collect OCT data to evaluate the range and age trend of eye measurements.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Able and willing to provide consent
* Able and willing to complete the required examininations and visit
* Refractive error within 8 diopters sphere and within 2 diopters cylinder in each eye
* Best corrected visual acuity of 20/30 or better in each eye

Exclusion Criteria:

* History of leukemia, AIDS, dementia or multiple sclerosis
* Concomitant use of hydroxycloroquine or chloroquine
* Family history of glaucoma among first degree relatives
* Intraocular pressure of 22mm Hg or greater in either eye
* Unreliable or abnormal visual field
* Active ocular disease
* Previously diagnosed with glaucoma or glaucoma suspect
* Congenital ocular abnormalities
* Previous intra-ocular surgery or laser treatment (other than refractive surgery or uncomplicated cataract surgery greater than 6 months previously)
* Anatomic narrow angle

Primary outcomes:
measure: range of eye measurements
timeFrame: Day 1
Secondary outcomes:
measure: age trend of eye measurements
timeFrame: Day 1
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Southern California College of Optometry
state: California
city: Pomona
country: United States
facility: College of Optometry, Western University of Health Sciences
state: California
city: San Jose
country: United States
facility: Buena Vista Eye Care
state: California
city: Chicago
country: United States
facility: Illinois Eye Institute
state: Illinois
city: London
country: United Kingdom
facility: Institute of Ophthalmology, University College London
state: England
Study officials:
affiliation: Southern California College of Optometry at Marshall B. Ketchum University
name: George Comer, OD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Illinois Eye Institute
name: Michael Chaglasian, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: Buena Vista Eye Care
name: Jorge Cuadros, OD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Ophthalmology, University College London
name: David Garway-Heath, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University of Health Sciences
name: Pinakin G Davey, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01557231: Epidemiology of Osteoarthritis (OA) Pain
Official title: Epidemiology of OA Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: OA
osteoarthritis
pain
variability
activity
treatment
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: ZARS Pharma Inc.
First posted: 2012-03-19
Enrollment: 86
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with OA

Brief summary: Chronic pain, by definition, persists over long periods of time, but both sufferers of pain and their caregivers are aware that pain levels can fluctuate greatly over time. Being able to define pain variability and its underlying causes would be an important advance in our understanding of chronic pain, and would in turn lead to better approaches to the treatment of chronic pain. In this study, the investigators propose to evaluate in 60 people with chronic pain of the knee due to osteoarthritis over 3 months, collecting data regarding magnitude of pain, physical activity level, and medication status twice daily during this period of time. The investigators then will assess the variability in pain levels over time, the frequency of "flares" of osteoarthritis (OA) pain and their relationship to physical activity, medications, and clinical descriptors of the population, e.g., age, gender, body mass index (BMI). Additionally, evaluations will be made regarding temporal patterns of OA knee pain as well as assessment of subgroups of patients with the overall group being studied.


Eligibility criteria: Inclusion Criteria:

1. Men and women, age 40 years and above
2. Knee pain most days of the week for the past month
3. Diagnosis of knee OA
4. Meet ACR criteria for knee OA
5. No significant limitations in physical activity
6. Own and able to use a cellular phone capable of text messaging
7. Able to return for all clinic visits
8. Able to read and understand the informed consent document

Exclusion Criteria:

1. Use of a walker to ambulate or inability to ambulate (use of cane is allowed)
2. Other forms of arthritis
3. Other major causes of pain that could be expected to interfere with assessment of pain during this trial, e.g., recurrent migraine, back pain, fibromyalgia
4. Scheduled for and likely to need joint replacement surgery in the next 3 months
5. Any medical condition that in the judgment of the investigator would make the participant not suitable for the study
6. Living in a long-term care facility

Primary outcomes:
measure: pain magnitude
timeFrame: 6 months
Secondary outcomes:
measure: self-reported activity level
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
References:
Clinical trial NCT05698927: Analgesic Effects of Intrathecal Morphine and Bilateral Erector Spina Plane Block in Elective Cesarean Section
Official title: Can Erector Spinae Plane Block Replace Intrathecal Morphine in Cesarean Section? a Prospective Randomized Controlled Study on Opioid Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Postoperative Pain
Keywords: postoperative pain
opioid consumption
erector spinae plane block
intrathecal morphine
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Cesarean section cause severe pain due to surgical incision, abdominal wall retraction and visceral organ movements. Cesarean section can be performed with general anesthesia, spinal anesthesia, epidural anesthesia and combined spinal epidural anesthesia methods.

Because of the possibility of aspiration pneumonia in pregnant women are under general anesthesia, the awareness of anesthesia in the mother during the operation due to insufficient anesthesia, unsuccessful intubation, respiratory complications in the mother and newborn and low APGAR scores, regional anesthesia is superior to general anesthesia in elective cesarean section operations.

Spinal anesthesia, abdominal wall blocks such as erector spinae plane block, parenteral and intrathecal opioids may be used for postoperative analgesia in cesarean section operations.

Intrathecal morphine can cause postoperative nausea-vomiting, itching, respiratory depression. Erector spina plane block can provide effective pain control and reduce opioid consumption.

The primary implication of this study is to compare postoperative pain scores and opioid consumption on elective cesarean section patients under spinal anesthesia with intrathecal morphine or erector spina block in addition to spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 40 years old, ASA (American Society of Anesthesiologists) score I-II, undergoing elective cesarean section

Exclusion Criteria:

* Emergency cesarean section
* The patients with major hepatic, cardiovascular or renal disease
* The patients for whom spinal anesthesia is contraindicated
* The patients who is allergic to any drugs that we use for this study
* Patients who declined to participate in the study

Primary outcomes:
measure: Opioid Consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Scores
timeFrame: 24 hours
measure: Rescue analgesia
timeFrame: 24 hours
measure: Side effects of medications
timeFrame: 24 hours
Other outcomes:
measure: Participant satisfaction
timeFrame: 24 hours
measure: Apgar scores of newborns
timeFrame: 1st and 5th minute after the delivery.
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Beliz Bilgili
role: STUDY_CHAIR
References:
Clinical trial NCT05307627: The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging
Official title: The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging - A Retrospective Cross-sectional Study Into Off-label Use of LDN
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Aging
Keywords: low-dose naltrexone
longevity
health status
quality of life
Lead sponsor: AgelessRx
Sponsor class: INDUSTRY
First posted: 2022-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible long-term (\>5 years), intermediate-term (1-5 years), and short-term (\<12 months) LDN users

Brief summary: This retrospective, observational study will assess the health status of short- and long-term low-dose naltrexone (LDN) users.

Detailed description: Long-term (\>5 years), intermediate-term (1-5 years), and short-term low-dose naltrexone (LDN) users (\<12 months) will be contacted for a retrospective, observational assessment of their health status. Participants will be asked to complete a series of questionnaires assessing their quality of life, general physical and mental health, family history, the occurrence of age-related diseases, and immune status. Additionally, blood tests for immune and longevity markers will be optional for a subset of participants.

Eligibility criteria: Inclusion Criteria:

* Adults (aged 18-120)
* Any sex
* Any ethnicity
* Taking LDN
* Willing to complete health questionnaires
* Technologically competent to complete web forms
* Subgroup: willing to undergo blood testing

Exclusion Criteria:

* LDN doses over 20 mg/day
* Terminal cancer patients (defined as stage IV and/or with a life expectancy of 12 months or less)

Primary outcomes:
measure: Quality of life score
timeFrame: At enrollment
measure: Immune Status
timeFrame: At enrollment
Secondary outcomes:
measure: General health and family history
timeFrame: At enrollment
measure: Levine's phenotypic age
timeFrame: At enrollment
measure: CD4/CD8 ratio
timeFrame: At enrollment
measure: CMV IgG
timeFrame: At enrollment
measure: hsCRP
timeFrame: At enrollment
measure: IL-6
timeFrame: At enrollment
measure: TNFɑ
timeFrame: At enrollment
measure: Methylation age clock testing
timeFrame: At enrollment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: AgelessRx
state: Michigan
Study officials:
affiliation: AgelessRx
name: Sajad Zalzala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02326727: Influence of Epidural Analgesia on Natural Killer Cell (NK) Activity After Colonic Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Neoplasms
Keywords: Epidural Analgesia
Natural Killer Cells
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Regional anesthesia may decrease the release of endogenous opioids, increase Natural Killer cell (NK) function and decrease development of metastasis. The recent analysis of the Cancer Registry has noted an improved 5-year survival in patients who received epidural analgesia during surgery for colorectal carcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing colonic cancer surgery

Exclusion Criteria:

* Patients with poor physical status Patients needed emergency surgery Coagulopathic disorders with international normalized ratio (INR) level more than 1.4 Thrombocytopenia with platelets count less 100000 per mcl Allergic reaction to local anesthetics in patient history Failure to performing the epidural analgesia from another cause Preoperative immunomodulating treatment Recent history of chemotherapy or radiation therapy

Primary outcomes:
measure: Count of live and dead target erythroleukemic cells
timeFrame: 72 hours
measure: Plasma concentration of cytokines
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT04252027: Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients
Official title: Therapeutic Drug Monitoring of Fluconazole in Critically Ill Patients: a Longitudinal Follow-up of Trough Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill Patients
Keywords: Pharmacokinetics
Fluconazole
Variability
Target attainment
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2020-02-05
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients.

Brief summary: This prospective study will research the exposure and its variability to fluconazole after longitudinal administration in critically ill patients

Detailed description: An open label, monocenter pharmacokinetic study will be carried out in critically ill patients, admitted at the University Hospitals Leuven, receiving multiple dose treatment with fluconazole.

The exposure to fluconazole in the ICU cohort over multiple days of treatment will be documented. Moreover, variability and the correlating covariates that can influence the fluconazole concentration, will be determined.

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Treatment with fluconazole
* Admitted to an ICU ward

Exclusion Criteria:

* \< 18 years
* DNR 2 or 3

Primary outcomes:
measure: Exposure to fluconazole (trough levels)
timeFrame: On the day of sampling
measure: Exposure to fluconazole (trough levels)
timeFrame: June 2020
Secondary outcomes:
measure: Variability in fluconazole trough levels
timeFrame: June 2020
measure: Influencing covariates
timeFrame: June 2020
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Isabel Spriet, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06928727: Ophtalmological Characteristics of Patients With Craniosynostosis Followed at the Amiens University Hospital
Official title: Ophtalmological Characteristics of Patients With Craniosynostosis Followed at the Amiens University Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Craniosynostosis
Strabismus
Intracranial Hypertension
Amblyopia
Keywords: Craniosynostosis
strabismus
, intracranial hypertension
amblyopia
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 65
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with craniosynostosis followed at the Amiens University Hospital.

Brief summary: Craniosynostosis are cranial deformations due to the premature closure of one or more cranial sutures. These deformations affect approximately one in 2.500 births. In the vast majority of cases, craniosynostoses are isolated (non-syndromic) and their origin is not always known. On the other hand, 20% of these deformations are said to be syndromic.

Craniosynostosis has morphological (associated dysmorphism) and functional (growth conflict between the skull and the brain) repercussions. Ophthalmological disorders are frequent: refractive disorders, oculomotor disorders, optic nerve damage, sensory damage.

This study aims to describe the ophthalmological clinical characteristics associated with craniosynostosis in patients followed at the Amiens University Hospital. This is a retrospective study based on the analysis of patient records followed in our center.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of craniostenosis

Exclusion Criteria:

* Posterior plagiocephalia

Primary outcomes:
measure: Number of ophthalmological clinical characteristics associated with craniosynostosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU Amiens
Study officials:
References:
Clinical trial NCT00497627: Quality of Life and Cardiometabolic Risk Factors in Patients After Debanding
Official title: Quality of Life and Cardiometabolic Risk Factors in Patients After Debanding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Patients
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Cantonal Hospital, Frauenfeld
First posted: 2007-07-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Follow up of debanding patients regarding cardiometabolic risk factors

Brief summary: Follow up of debanding patients

Detailed description: Follow up of debanding patients regarding cardiometabolic risk factors

Eligibility criteria: Inclusion criteria:

* Previous debanding after lap. gastric bypass

Exclusion criteria:

* Further bariatric procedures

Primary outcomes:
measure: Quality of Life
timeFrame: 2 to 5 years after debanding
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT02464527: Stimulus-Stimulus Pairing Study
Official title: A Pilot Feasibility Study to Increase Vocal Language in Minimally Verbal Children Diagnosed With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Stimulus-stimulus pairing
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 16
Sex: ALL
Minimum age (years): 24
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the current study is to deliver the SSP procedure to children diagnosed with autism that do not have vocal language. The study will also aim to gather data in the natural environment using a voice recorder.

Detailed description: The purpose of this study is to teach children with autism who do not produce sounds or words to vocalize sounds or words by using the stimulus-stimulus pairing (SSP) procedure. The investigators will use SSP, an intervention based in behavior analysis, to try to help the child vocalize sounds. A vocal recorder will also be sent home so that the caregiver can record the child's vocalization at home. The caregiver will then be asked to return this so that the investigators can listen to it. By doing this, the investigators hope to learn if the treatment helps increase the child's vocalizations at home. Some children in the study will receive treatment immediately. Some children may enroll in the study now but not receive intervention until a later date. All children in the study will receive treatment within one year of enrolling in the study.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of autism
2. Currently do not emit vocalizations or minimally verbal
3. Willingness of the participant's parent/guardian to bring their child to the Marcus Autism Center for one-hour appointments, five days a week, for six weeks.

Exclusion Criteria:

1. Children with significant problem behavior that interferes with structured intervention

Primary outcomes:
measure: Feasibility of intervention assessed by a change in frequency of target vocalizations and/or approximations during sessions
timeFrame: Week 1, Week 6
measure: Change in frequency of target vocalizations and/or approximations at home
timeFrame: Week 1, Week 6
measure: Change in parent-reported vocalizations
timeFrame: Week 1, Week 6
measure: Feasibility of intervention assessed by reliability of delivery by therapists
timeFrame: Week 6
measure: Acceptability of stimulus-stimulus pairing (SSP) by parents
timeFrame: Week 6
Secondary outcomes:
measure: Feasibility of intervention assessed by compliance of the vocal recorder
timeFrame: Week 6
measure: Feasibility of the vocal recorder assessed by the utility of vocal recorder
timeFrame: Week 6
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Marcus Autism Center
state: Georgia
Study officials:
affiliation: Emory University
name: Alice Shillingsburg, PhD
role: PRINCIPAL_INVESTIGATOR
References: