louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01406691: Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Official title: Treating Sleep Disruption in Teens With Millisecond Light Exposure During Sleep
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Delayed Sleep Phase Disorder
Keywords: sleep
delayed sleep phase disorder
circadian
teen
adolescent
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Delayed Sleep Phase Disorder (DSPD) is a sleep disruption that commonly occurs in teens and manifests as a difficulty in waking up in the morning, going to sleep early enough at night, and daytime disturbances such as depression, fatigue, and restlessness. The purpose of this study is to determine if brief flashes of light, that are scheduled to occur during sleep, are effective in treating DSPD.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Full-time in high school
* primary sleep complaint consistent with delayed sleep phase disorder

Exclusion Criteria:

* sleep only in prone position
* currently taking medications specifically for the treatment of a sleep disorder

Primary outcomes:
measure: Sleep quality
timeFrame: weekly for four weeks
Secondary outcomes:
measure: Mood
timeFrame: at the begining and end of intervention (4 weeks)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References:
citation: Zeitzer JM, Ruby NF, Fisicaro RA, Heller HC. Response of the human circadian system to millisecond flashes of light. PLoS One. 2011;6(7):e22078. doi: 10.1371/journal.pone.0022078. Epub 2011 Jul 8.
citation: Zeitzer JM, Fisicaro RA, Ruby NF, Heller HC. Millisecond flashes of light phase delay the human circadian clock during sleep. J Biol Rhythms. 2014 Oct;29(5):370-6. doi: 10.1177/0748730414546532. Epub 2014 Sep 16.
citation: Joyce DS, Spitschan M, Zeitzer JM. Optimizing Light Flash Sequence Duration to Shift Human Circadian Phase. Biology (Basel). 2022 Dec 13;11(12):1807. doi: 10.3390/biology11121807.
citation: Joyce DS, Spitschan M, Zeitzer JM. Duration invariance and intensity dependence of the human circadian system phase shifting response to brief light flashes. Proc Biol Sci. 2022 Mar 9;289(1970):20211943. doi: 10.1098/rspb.2021.1943. Epub 2022 Mar 9.
citation: Kaplan KA, Mashash M, Williams R, Batchelder H, Starr-Glass L, Zeitzer JM. Effect of Light Flashes vs Sham Therapy During Sleep With Adjunct Cognitive Behavioral Therapy on Sleep Quality Among Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911944. doi: 10.1001/jamanetworkopen.2019.11944.
Clinical trial NCT02351791: An Exploratory Study Investigating Human Skin Reaction to Output
Official title: An Exploratory Study Investigating Human Skin Reaction to Output
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2015-01-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.

Detailed description: Six types of patches are tested:

Patch 1: Standard adhesive with own feces

Patch 2: Standard adhesive with own feces mixture

Patch 3: Standard adhesive with simulated feces

Patch 4: Standard adhesive with simulated feces mixture

Patch 5: Standard adhesive with buffer (control)

Patch 6: Standard adhesive with buffer feces mixture (control)

Each subject is randomized to one of two arms testing three patches on the peristomal skin (patch 1, 3 and 5 or patch 2, 4 and 6). Furthermore, within each arm an attempt will be made to randomize each of the three patches on the peristomal skin to one of three locations surrounding the stoma (upper left, upper right, lower). On the healthy contralateral abdominal skin the subjects test all six patches.

A run in period with 2 subjects (healthy volunteers) was conducted to clarify the length of the test period. They were exposed to 4 patches (patch 3-6) on healthy abdominal skin which was removed at 2 different time slots. Based on the results the test period was established

Eligibility criteria: Inclusion Criteria:

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Have had an ileostomy for more than one year
* Have normal to slightly red skin on the area used in the evaluation
* Has an ileostomy with a diameter up to (≤) 35 mm
* Have a peristomal area accessible for applied patches (assessed by investigator)

Exclusion Criteria:

* Currently receiving or have within the past 2 months received radio- and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
* Are pregnant or breastfeeding
* Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
* Participating in other interventional clinical investigations or have previously participated in this investigation

Primary outcomes:
measure: Trans Epidermal Water Loss After Test of Patches.
timeFrame: Approximately 7-10 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Videncenter for Saarheling
Study officials:
affiliation: Coloplast A/S
name: Lene F Nielsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02536391: Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects
Official title: A Phase 1, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of Ipatasertib (GDC-0068) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase I, open-label, randomized, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be determined. Participants will be randomized to one of six treatment sequences to receive three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 3 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females, between 18 and 55 years of age, inclusive
* Body mass index between 18.5 and 29.9 kg/m\^2, inclusive

Exclusion Criteria:

- Clinically significant findings from medical history or screening evaluations.

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) of Ipatasertib
timeFrame: Days 1, 8 and 15
measure: Time to Maximum Concentration (tmax) of Ipatasertib
timeFrame: Days 1, 8 and 15
measure: Area Under the Concentration-time Curve (AUC) from Hour 0 to the Last Quantifiable Concentration (AUC0-t) of Ipatasertib
timeFrame: Days 1, 8 and 15
measure: Area Under the Concentration-time Curve (AUC) from Hour 0 Extrapolated to Infinity
timeFrame: Days 1, 8 and 15
measure: Apparent Terminal Elimination Half-Life (t1/2) of Ipatasertib
timeFrame: Days 1, 8 and 15
measure: Apparent Total Clearance (CL/F) of Ipatasertib
timeFrame: Days 1, 8 and 15
measure: Apparent Volume of Distribution (Vz/F) of Ipatasertib
timeFrame: Days 1, 8 and 15
Secondary outcomes:
measure: Percentage of Participants with Adverse Events
timeFrame: From check in (Day -1) to 30 days after the last dose of study drug
Other outcomes:
Locations:
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Malhi V, Budha N, Sane R, Huang J, Liederer B, Meng R, Patel P, Deng Y, Cervantes A, Tabernero J, Musib L. Single- and multiple-dose pharmacokinetics, potential for CYP3A inhibition, and food effect in patients with cancer and healthy subjects receiving ipatasertib. Cancer Chemother Pharmacol. 2021 Dec;88(6):921-930. doi: 10.1007/s00280-021-04344-9. Epub 2021 Sep 1.
Clinical trial NCT06578091: Executive Function in Obese
Official title: Effects of Executive Dysfunction on Physical Performance and General Well-Being in Obese Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Keywords: obesity
executive functions
physical performance
well-being
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with BMI ≥30 kg/m2

Brief summary: This study was planned to examine the effect of executive function problems on physical performance and general well-being in obese individuals.


Eligibility criteria: Inclusion Criteria:

For the study group;

* Individuals volunteering for the study with BMI ≥30 kg/m2
* Individuals between the ages of 18-65 who volunteer to work
* Individuals who scored 21 points and above in the cognitive assessment

For the control group;

* Individuals volunteering for the study with BMI ≥30 kg/m2
* Individuals between the ages of 18 and 65 who are willing to work
* Scoring less than 21 points on the cognitive assessment

Exclusion Criteria:

* Being at a mental level that cannot understand and answer the questions posed
* Having a diagnosed neurological disease
* Having had cancer within the last 2 years
* Having major organ dysfunction
* Having uncontrolled type 2 diabetes
* Loss of vision, hearing

Primary outcomes:
measure: Executive function
timeFrame: Baseline
measure: General Well-Being-Sleep Quality
timeFrame: Baseline
measure: General Well-Being-Quality of Life
timeFrame: Baseline
measure: Physical Performance-Timed Up and Go
timeFrame: Baseline
measure: General Well-Being-Depression and Anxiety
timeFrame: Baseline
measure: Physical Performance-Hand Grip Strength
timeFrame: Baseline
measure: Physical Performance-Walking Speed
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
state: Central
Study officials:
References:
Clinical trial NCT04895891: 3D Personalized Modelization of the Hand Using EOS Imaging System
Official title: 3D Personalized Modelization of the Hand Using EOS Imaging System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Injuries
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to compare the quality of 3D hand modelization with EOS imaging with gold-standard computed tomography


Eligibility criteria: Inclusion Criteria:

* Patient with hand/wrist CT required
* Informed consent form signed

Primary outcomes:
measure: Data obtained through EOS imaging
timeFrame: Day 60
measure: Data obtained through standard CT
timeFrame: Day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT06708091: Real-world Clinical Effectiveness and Patient Insight Associated With Adding Sodium Glucose Co-transporter 2 Inhibitor to Gliclazide Modified Release
Official title: A Retrospective Chart Review Combined With a Prospective Cross-sectional Survey and Interviews on Patients With Type 2 Diabetes Mellitus to Assess Effectiveness of Adding SodiumGlucose Co-transporter 2 Inhibitor to Gliclazide Modified Release
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: observational
HbA1c
type 2 diabetes
gliclazide MR
SGLT2i
gliclazide MR combined to SGLT2i
retrospective
chart review
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2024-11-27
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female who are treated by Gliclazide MR 60 at index date and who started with SGLT2i added to gliclazide MR with a minimum of 60 days of these combined treatments during the eligibility period

Brief summary: The study objectives are to assess over the gliclazide MR-SGLT2i combined treatment course in patients with T2DM adding SGLT2i to gliclazide MR-based therapy.

The primary objective is to determine the effectiveness of adding SGLT2i to gliclazide MR-based therapy in patients with T2DM, as measured by HbA1c changes.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with T2DM for at least two years prior to index date
* Patient aged ≥18 years at the index date
* Patient naïve to SGLT2i prior to index date
* Patient treated with gliclazide MR at a minimum daily dose of 60 mg at the index date
* Starting treatment with SGLT2i added to gliclazide MR based therapy, during the eligibility period, with a minimum of 60 days of combined gliclazide MR-SGLT2i treatment
* Presence of at least two assessments of HbA1c laboratory test results from the medical records

Exclusion Criteria:

* Diagnosis of diabetes other than T2DM (e.g., type 1, gestational) at index date
* Use of antidiabetic drugs other than those permitted by the inclusion criteria, at index date

Primary outcomes:
measure: effectiveness of adding SGLT2i to gliclazide MR
timeFrame: from index date (date of SGLT2i adding to gliclazide MR) to discontinuation of the combination (at least 2 months) or date of data collection initiation during the eligibility period, loss to follow-up, or death, whichever occurs first (approx 2 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Servier Affaires Médicales
Study officials:
References:
Clinical trial NCT02431091: Evaluation of the Role of OCT in the Detection of HIV-associated Neurocognitive Disorder
Official title: Evaluation of the Role of Optical Coherence Tomography (OCT) in the Detection of HIV-associated Neurocognitive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AIDS-Related Dementia Complex
Keywords: Optical Coherence Tomography
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
Collaborators: name: Fonds iris-Recherche, Fondation Roi Baudouin, Belgium
First posted: 2015-04-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the sensitivity and specificity of the use of optical coherence tomography to detect HIV-associated neurocognitive disorder compared to MRI and usual cognitive screening tools.


Eligibility criteria: Inclusion Criteria:

* HIV infection
* Antiretroviral treatment
* Undetectable plasmatic HIV viral load (viral load\<50 copies/ml) for at least 6 months
* Ability to understand and give approved consent

Exclusion Criteria:

* Any present or past ophthalmologic illness that may impair OCT results
* Previous cerebral infection with sequel
* Previous cerebrovascular disease with sequel
* Severe psychiatric illness
* Active alcohol or drug abuse
* Active chronic hepatitis C
* Inability to perform french cognitive assessment
* Inability to perform a MRI
* Inability to perform a lumbar puncture

Primary outcomes:
measure: Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluation
timeFrame: Baseline
Secondary outcomes:
measure: Number of patients with abnormal neuroscreen and/or modified dementia scale in patients with abnoraml full neurocognitve evaluation
timeFrame: Baseline
measure: Correlation between retinal thickness (in µm) and cerebral atrophy in % of brain parenchymal fraction ( measured by cerebral MRI)
timeFrame: Baseline
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hopital St Pierre
Study officials:
affiliation: CHU St Pierre, Service des Maladies Infectieuses
name: Stéphane Dewit, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02958891: Dental Health Epidemiology Among Israel Defense Forces (IDF) Recruits
Official title: Caries, Gingivitis, Dental Trauma and Fluorosis Prevalence Among IDF Recruits - an Epidemiological Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Caries, Dental
Gingivitis
Fluorosis
Dental Trauma
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
First posted: 2016-11-08
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General IDF recruits.

Brief summary: An epidemiological survey for prevalence description of dental morbidity (caries, gingivitis, dental trauma and fluorosis) among Israel Defense Forces (IDF) general recruits. Morbidity measures were collected from 700 recruits at their first day of military service in order to evaluate extent and burden of dental diseases among recruits. The data will enable the military dental services commanders to plan and implement dental services according to the dental needs.

Detailed description: Caries, gingivitis, dental trauma and fluorosis epidemiological measures were collected among IDF recruits in 700 sample using short clinical evaluation without radiographs. water fluoridation ecological data will be obtained from the ministry of health. the results might impact dental services plan, professional manpower system, and the layout of the dental clinics in the IDF. It will give the professionals in the military dental services an evidence based data for planning an accurate primary and secondary prevention programs and an evaluation of dental diseases burden in order to have the "full picture" of recruits dental needs. .

Eligibility criteria: Inclusion Criteria:

* Above 18 years old.

Exclusion Criteria:

* Chronic bone diseases.
* Mineralization defects

Primary outcomes:
measure: DMFT index (Decayed, Missing, Filled, Tooth)
timeFrame: 7 days
measure: CPI (Community Periodontal Index) index
timeFrame: 7 days
measure: TDI (Dental Trauma Index) index
timeFrame: 7 days
measure: TF (Thylstrup & Fejerskov Index for dental Fluorosis) index
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: IDF Medical Corps
Study officials:
affiliation: IDF Medical Corps
name: Nirit Yavnai, DMD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yavnai N, Mazor S, Vered Y, Shavit I, Zini A. Caries prevalence among 18 years old, an epidemiological survey in Israel. Isr J Health Policy Res. 2020 Aug 31;9(1):45. doi: 10.1186/s13584-020-00402-4.
Clinical trial NCT06624891: Interest of the Pleth Variability Index in Neurosurgery
Official title: Evaluation of Perioperative Fluid Responsiveness in Neurosurgery: Interest of the Pleth Variability Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Monitoring
Hypovolemia
Fluid Challenge
Lead sponsor: National Institute of Neurology, Tunisia
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective comparative randomized clinical trial
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to study the interest of the Pleth Variability Index (PVI) to evaluate perioperative fluid responsiveness in neurosurgery in adults.

The main question it aims to answer is:

• Does the Pleth variability index predict fluid responsiveness in neurosurgery? Researchers will compare the Pleth variability index to dela PP to see if it predicts fluid responsiveness in neurosurgery.

Once participants give their consent, they will be randomly assigned to one of two groups. In one group, fluid responsiveness will be monitored using the Pleth Variability Index, while in the other group, it will be monitored using delta PP.


Eligibility criteria: Inclusion Criteria:

1. Patients proposed for intracranial surgery
2. Must be aged 18 and over
3. Must be classified as ASA I, ASA II, and ASA III according to the American Society of Anesthesiologists classification

Exclusion Criteria:

1. Non-consenting patients
2. Patients classified ASA IV or higher
3. Cardiac arrhythmia
4. Heart disease with left ventricular ejection fraction less than 45%
5. Obesity with a BMI greater than 40 Kg/m2.
6. Peripheral vascular disease
7. Severe lung disease
8. End-stage renal disease
9. Intraoperative cardiac arrhythmia
10. The occurrence of cardiac arrest
11. The occurrence of hemorrhagic shock
12. Intraoperative use of low tidal volumes or high respiratory rates.

Primary outcomes:
measure: Value of PVI in fluid responsiveness in neurosurgery
timeFrame: chanfe of PVI value from baseline to a value more than 14% and untill the end of surgery
Secondary outcomes:
measure: Amount of fluids administered intraoperatively
timeFrame: during the surgery
measure: Renal, metabolic and hydroelectrolytic repercussions.
timeFrame: up to the first 24 hours postoperatively
measure: Length of postoperative stay
timeFrame: up to hospital discharge, an average of 4 days
measure: Incidence of post-operative complications
timeFrame: up to hospital discharge, an average of 4 days
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: National Institute of Neurologie Mongi Ben-Hamida
Study officials:
References: