louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03085160: Project EAT: Eating and Attitudes in Teens
Official title: Project EAT: Eating and Attitudes in Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Adolescent Development
Stress
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 54
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Research suggests there is a connection between mood and weight. People who feel stressed or depressed are more likely to be overweight than people who don't have these feelings. Some individuals turn to food to cope, which can lead to gaining too much weight over time. Adolescence is an important time to understand these connections. Patterns of handling stress learned during adolescence set the stage for stress management in adulthood. This study is a randomized controlled pilot study with 60 adolescents who are at-risk for future, chronic obesity. The investigators will test if taking part in a 6-week group program to lower stress and improve mood will be helpful to teens at-risk.


Eligibility criteria: Inclusion Criteria:

* Age 12-17 years
* At-risk for long-term obesity by virtue of current BMI (≥70th percentile for age and sex) or obesity (BMI ≥30 kg/m2) in both biological parents
* Good general health

Exclusion Criteria:

* Current full-syndrome psychiatric disorder that in the investigators' opinion would impede study compliance
* Major medical problem such as type 2 diabetes
* Use of medication affecting mood or body weight such as stimulants or anti-depressants
* Any medical issues that could be acutely worsened by exercise such as asthma or musculoskeletal problems.
* Pregnancy in females

Primary outcomes:
measure: Feasibility of study
timeFrame: 3 years
measure: Acceptability of program
timeFrame: 6 weeks
measure: Acceptability of study participation
timeFrame: 6 weeks
Secondary outcomes:
measure: Perceived stress
timeFrame: 6 months
measure: Executive function
timeFrame: 6 months
measure: Food reward sensitivity
timeFrame: 6 months
measure: Meal intake
timeFrame: 6 months
measure: Weight gain
timeFrame: 6 months
measure: Fat gain
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
References:
citation: Shomaker LB, Berman Z, Burke M, Annameier SK, Pivarunas B, Sanchez N, Smith AD, Hendrich S, Riggs NR, Legget KT, Cornier MA, Melby C, Johnson SA, Lucas-Thompson R. Mindfulness-based group intervention in adolescents at-risk for excess weight gain: A randomized controlled pilot study. Appetite. 2019 Sep 1;140:213-222. doi: 10.1016/j.appet.2019.05.022. Epub 2019 May 18.
Clinical trial NCT05690360: Pregnancy Outcomes of Patients Having NC-FET Regarding the Progesterone Levels
Official title: Evaluation of the Pregnancy Outcomes and Time to Embryo Transfer Regarding the Progesterone Levels of Natural Cycle-FETs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are going to be selected from the patients who applied to infertility clinic, and are pregnant with in vitro fertilization natural cycle- frozen embryo transfer.

Brief summary: We recently identify in our previous study 'NCT052115832' the progesterone levels for the embryo transfer in natural thaw cycles. Since it is shown that progesterone levels work better than LH levels in order to detect the time to transfer, we aimed to show the pregnancy outcomes of the natural thaw cycles which had the transfer date regarding the progesterone levels.


Eligibility criteria: Inclusion Criteria:

* patients with regular menstrual cycle
* patients aged btw 20-40
* patients with pregnancy with NC-FET by using the progesterone for the detection of ovulation

Exclusion Criteria:

* Spontenous pregnancies
* Multiple pregnancies

Primary outcomes:
measure: Cummulative Live Birth Rate
timeFrame: 10 months
measure: Biochemical pregnancy results
timeFrame: 2 months
measure: Pregnancy complications
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem University Atakent Hospital
Study officials:
affiliation: Acıbadem University School of Medicine
name: NAZLI ALBAYRAK, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Acıbadem University School of Medicine
name: TURGUT AYDIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Acıbadem University School of Medicine
name: NADIYE KOROGLU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03716960: The Effects of Pumpkin Seed Oil Supplementation on Cardiovascular Function in Postmenopausal Women.
Official title: The Effects of Pumpkin Seed Oil Supplementation on Vascular Hemodynamics, Stiffness and Cardiac Autonomic Function in Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elevated Blood Pressure
Hypertension
Lead sponsor: Marymount University
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 23
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Postmenopausal women have a higher prevalence of cardiovascular (CV) disease than age-match men. Growing evidence from rat studies have demonstrated CV-protective effects of pumpkin seed oil (PSO).

The investigators hypothesis is that PSO would improve CV health in postmenopausal women.

Detailed description: The purpose of the study is to examine the effects of 6 weeks of PSO on arterial and autonomic function in postmenopausal women. Specific aims of the study are to:

To investigate the extent to which PSO will improve cardiovascular disease risk factors by assessing arterial stiffness, aortic BP and wave reflection, and autonomic function (heart rate variability).

Eligibility criteria: Inclusion Criteria:

* Female
* 45 to 65 years of age
* At least 1 year after menopause
* BMI \<39.9
* Sedentary or low active (less than 2 hr per wk)

Exclusion Criteria:

* known heart disease
* peripheral vascular disease
* diabetes, body mass index
* BMI\> 40 kg/m2
* other chronic diseases
* taking medications (e.g., hormone replacement therapy, beta blockers, calcium channel blockers, antidepressants and stimulants) that could affect the outcome variables
* smokers
* history of steady exercise or received exercise training and dietary changes in the last year

Primary outcomes:
measure: Blood pressure
timeFrame: 6 weeks
measure: Pressure Wave Reflection
timeFrame: 6 weeks
measure: Arterial Stiffness
timeFrame: 6 weeks
measure: Heart rate variability
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Arlington
country: United States
facility: Marymount University
state: Virginia
Study officials:
affiliation: Marymount University
name: Alexei Wong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong A, Viola D, Bergen D, Caulfield E, Mehrabani J, Figueroa A. The effects of pumpkin seed oil supplementation on arterial hemodynamics, stiffness and cardiac autonomic function in postmenopausal women. Complement Ther Clin Pract. 2019 Nov;37:23-26. doi: 10.1016/j.ctcp.2019.08.003. Epub 2019 Aug 8.
Clinical trial NCT05019560: Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique
Official title: Detection of Responsiveness and Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Awareness, Anesthesia
Recall Phenomenon
Inhalation; Gas
Keywords: TIVA
Isoflurane
old age
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventions: Patients were randomized into either Group A (who received inhalational induction) and Group B (who received total intravenous induction followed by maintenance infusion).

Main outcome measure: IFT response was recorded at laryngoscopy and intubation to identify awareness at this stressful timepoint.
Primary purpose: DIAGNOSTIC

Brief summary: Awareness during general anesthesia - that has an incidence between 0.1% and 0.9% of cases and may be more in elderly - remains a concern for anesthesiologists. Awareness experiences range from isolated auditory perceptions to reports of a patient being fully awake, immobilized, and in pain. The isolated forearm technique allows assessment of consciousness of the external world (connected consciousness) through a verbal command to move the hand (of a tourniquet-isolated arm) during intended general anesthesia.

Detailed description: Objective: To compare inhalational induction versus intravenous induction regarding awareness during laryngoscopy and intubation in elderly patients undergoing day case elective surgery.

Eligibility criteria: Inclusion Criteria:

* 50 American society of anesthesiologists- Physical status (ASA-PS) I and II patients,
* aged 60 to 80 years,
* 70-80 kg,
* both sexes,
* with intact hearing,
* undergoing elective day case surgery were included in the study.

Exclusion Criteria:

1. Uncooperative patients,
2. Language barrier problems,
3. Psychological disorders,
4. Suspected difficult intubation,
5. History of awareness under anesthesia,
6. History of substance abuse,
7. The inability to have tourniquet on arm for the IFT (e.g., lymphedema or operative site)
8. Neuromuscular disorders.
9. Advanced renal, hepatic, cardiac, respiratory or neurological dysfunction
10. If rapid sequence induction was indicated (not suitable for inhalation induction).

Primary outcomes:
measure: IFT response was recorded at laryngoscopy and intubation
timeFrame: 10 minutes
Secondary outcomes:
measure: Bispectral index monitor (BIS)
timeFrame: 40 minutes
measure: Modified Brice questionnaire
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT01909960: Flow MRI in Normal Pressure Hydrocephalus
Official title: Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Normal Pressure Hydrocephalus
Keywords: Normal pressure hydrocephalus
Flow MRI
Dementia
Cerebrospinal fluid
Shunt
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-07-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging.


Eligibility criteria: Inclusion Criteria:

* Ventricular dilation seen on morphological magnetic resonance imaging (MRI)
* Walking disorder
* Cognitive disorder
* Participants gave their written informed consent

Exclusion Criteria:

* Contra-indication to MRI
* Obstructive tumoral hydrocephalus
* Curatorship or tutorship
* Pregnancy or lactation
* No social assurance

Primary outcomes:
measure: cerebrospinal fluid (CSF) stroke volume evolution other 6 months
timeFrame: Day 1 (baseline), Day 180
Secondary outcomes:
measure: Blood flow analysis : evolution other 6 months
timeFrame: Day 1 (baseline), Day 180
measure: Larson's score evolution over 6 months
timeFrame: Day 1, Day 180
measure: Neuropsychological test evolution over 6 months
timeFrame: Day1, Day 180
measure: Blood flow analysis : evolution other one year
timeFrame: Day 1 (baseline) and Day 365
measure: Larson's score evolution over one year
timeFrame: Day 1 and Day 365
measure: Neuropsychological test evolution over one year
timeFrame: Day1, Day 365
measure: cerebrospinal fluid (CSF) stroke volume evolution other one year
timeFrame: Day1 (baseline), Day 365
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU Lille
state: Nord Pas De Calais
city: Amiens
country: France
facility: CHU Amiens
state: Picardie
Study officials:
affiliation: CHU Amiens
name: Olivier Balédent, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01400360: Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage
Official title: Invasive Diagnostic and Therapeutic Management of Cerebral Vasospasm After Aneurysmatic Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Vasospasm After Subarachnoid Hemorrhage
Keywords: cerebral vasospasm
subarachnoid hemorrhage
transluminal balloon angioplasty
intraarterial treatment
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral vasospasm(CVS) after subarachnoid hemorrhage (SAH) results in a considerable amount of transient or even permanent neurological deficits and poor outcome of the patients. Transluminal Balloon angioplasty (TBA) or intraarterial application of vasodilators represents a rescue therapy for severe CVS. Indication, duration and efficacy of this treatment, however, is still under debate. Aim of the study is to investigate if such a rescue treatment can significantly reduce new delayed ischemic cerebral deficits after SAH. Hypothesis is that the occurance of delayed infarcts can be reduced by repetetive intraarterial therapy to more than 50 %.


Eligibility criteria: Inclusion Criteria:

* SAH (WFNS 1-4)
* Perfusion relevant CVS
* Ability for MRI, DSA and intraarterial treatment

Exclusion Criteria:

* extended cerebral infarcts
* SAH or ICH from AVM or flow associated aneurysm
* Non aneurismal SAH
* Relevant non spastic stenosis of brain supplying arteries

Primary outcomes:
measure: New infarcts between baseline and final MRI
timeFrame: 21 + - 7 days
Secondary outcomes:
measure: Clinical outcome (mRS, Karnofsky)
timeFrame: 6 months
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Neurochirurgische Klinik, Universitätsklinik
city: Frankfurt am Main
country: Germany
facility: Department of Neurosurgery, Johann Wolfgang Goethe-University
city: Günzburg
country: Germany
facility: Neurochirurgische Klinik der Universität Ulm
city: Jena
country: Germany
facility: Klinik für Neurochirurgie, Universitätsklinikum
city: Mannheim
country: Germany
facility: Klinik für Neurochirurgie, Universitätsklinikum
Study officials:
References:
Clinical trial NCT03234660: Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia
Official title: The Effects of Dexmedetomidine on the Neurotoxicity From General Anesthesia Assessed by Plasma Glial Fibrillary Acidic Protein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dexmedetomidine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Neuroapoptosis is induced by the administration of anesthetic agents to the young brain. Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role during development and is neuroprotective in several settings of neuronal injury in animals. We hypothesized that neuroprotective effect of dexmedetomidine would be associated with evidence of brain injury detected by elevation of plasma concentration of glial fibrillary acid protein in children undergoing general anesthesia.

Detailed description: GFAP measure

Eligibility criteria: Inclusion Criteria:

* children undergoing general anesthesia longer than 3 hours

Exclusion Criteria:

* past history of anesthesia
* cardiopulmonary bypass
* preexisting neurocognitive dysfunction
* abnormalities of liver profile (aspartate transaminase \> 40 unit/L, alanine aminotransferase \> 40 unit/L)

Primary outcomes:
measure: Glial fibrillary acid protein
timeFrame: change from baseline glial fibrillary acid protein at 3 hours after the anesthetic induction
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
References:
Clinical trial NCT01007760: Dose-dependent Effects of Second-hand Smoke on Vascular Function
Official title: Dose-dependent Biological Mechanisms of Second-hand Smoke on Endothelial Function and Oxidative Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Tobacco smoke
Oxidative stress
Endothelial Function
Atherosclerosis
Arterial Stiffness
Microvascular Function
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the vascular effects of brief second-hand smoke exposure on normal healthy individuals.

Detailed description: Second-hand smoke remains a significant public health threat. Despite evidence to suggest that secondhand smoke contributes to adverse cardiovascular outcomes, little is known about the dose-dependent vascular effects of brief secondhand smoke exposure at low doses commonly encountered in the community. This study will investigate the acute vascular effects and dose-dependent biological mechanisms of secondhand smoke on endothelial function and oxidative stress.

Eligibility criteria: Inclusion Criteria:

* Healthy non-smoking adults

Exclusion Criteria:

* Reported Active Smoking
* History of diabetes, hypertension, chronic respiratory disease, coronary artery disease, prior myocardial infarction or heart failure
* Pregnancy or breastfeeding
* Current use of prescription drugs within 14 days of trial
* Reported significant passive smoke exposure or elevated cotinine levels

Primary outcomes:
measure: Brachial Artery Flow-mediated dilation (FMD)
timeFrame: Same day - before/after exposure
Secondary outcomes:
measure: Plasma measurement of asymmetric dimethylarginine (ADMA) and Nitrotyrosine levels
timeFrame: Same day - before/after exposure
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF San Francisco General Hospital
state: California
Study officials:
affiliation: UCSF San Francisco General Hospital
name: Peter Ganz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05530460: Comparative Study of High Performance Low-Cost Optical Coherence Tomography
Official title: Comparative Study of High Performance Low-Cost Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optical Coherence Tomography of Retina
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-09-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to complete performance testing of our custom optical coherence tomography (OCT) device to verify it can deliver retinal images of similar quality to a commercial OCT device.

Detailed description: There is some evidence that certain changes in retinal structures could be an indicator of Alzheimer's disease (AD). We are developing a new technology that combines optical coherence tomography (OCT) and angle-resolved low coherence interferometry (a/LCI) to make light scattering measurements of retinal tissue structure. The objective of this device feasibility study is to compare performance characteristics of our custom OCT instrument to a commercial OCT instrument. Once we have optimized our device, we may use it in future studies to identify retinal structure changes that could be possible AD biomarkers.

For this study, the team will recruit healthy volunteers to attend one study visit that is about 30 minutes long. This visit will include examination with our custom OCT instrument, followed by examination with a commercial OCT system.

Eligibility criteria: Inclusion Criteria:

* able to provide informed consent

Exclusion Criteria:

* potentially confounding ocular conditions, such as: glaucoma, current corneal injury, retinal damage, diabetes, corrected distance visual acuity worse than 20/40
* eyes that have had intraocular surgery, other than cataract surgery

If two eyes satisfy the inclusion / exclusion criteria, both eyes will be included in the study. If only one eye satisfies the criteria, only the qualifying eye will be included in the study.

Primary outcomes:
measure: Number of Participants with Acceptable OCT Image Quality as Measured by Low-Cost OCT Device
timeFrame: during study procedures (30 minutes)
Secondary outcomes:
measure: Contrast-to-Noise Ratio (CNR)
timeFrame: during study procedures (30 minutes)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Adam Wax, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04246060: Observational Study to Assess the Quality of Life in Nephropathic Cystinosis Patients
Official title: Multicentre, Ambispective, Observational, Real Life Study to Assess the Quality of Life Effectiveness of Extended Release (ER) Oral Cysteamine Therapy (Procysbi) in Belgian Patients Suffering From Nephropathic Cystinosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Nephropathic Cystinosis
Lead sponsor: Chiesi SA/NV
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All Belgian nephropathic cystinosis patients.

Brief summary: Most of the real world evidence data related to efficacy of cysteamine therapy is retrospective. This study is a ambispective study to investigate the impact of cystine depletion therapy on the quality of life of patients and their parents.


Eligibility criteria: Inclusion criteria:

* Confirmed diagnosis of nephropathic cystinosis
* Undergoing cystine depletion therapy with oral cysteamine
* Signature of informed concent.

Primary outcomes:
measure: to descriptively assess the change from baseline and percent change from baseline in the quality of life overall summary sores at 12 months in switch cohort
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: UZA
city: Brussels
country: Belgium
facility: HUDERF
city: Brussel
country: Belgium
facility: UCL Saint-Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHC
city: Liège
country: Belgium
facility: CHU
Study officials:
References: