louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05218109: Stress and Sleep Study
Official title: Non-pharmacological Interventions to Improve Stress and Sleep Among College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Sleep
Transcutaneous Electric Nerve Stimulation
Vagus Nerve Stimulation
Mindfulness
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This between-subject, longitudinal pilot study in healthy college students aims to explore the acceptability and preliminary outcomes of two novel and complementary interventions that may improve stress and sleep: transcutaneous vagus nerve stimulation (tVNS) and a mobile mindfulness intervention.


Eligibility criteria: Inclusion Criteria:

* Undergraduate student (ages 18-30)
* Must own a smartphone
* Must be able to read and write English

Exclusion Criteria:

* Major medical illnesses including diagnosed severe neurological illnesses (e.g., stroke, seizure history), medical conditions associated with neurological effects (e.g. heart, kidney disease), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia)
* Pregnancy
* History of brain surgery, tumor, intracranial metal implantation, pacemakers or other implanted devices
* History of adverse reaction to electrical nerve stimulation
* Prescribed sleep medications and/or psychotropic medications
* Illicit or prescription drug abuse within the last two months (marijuana or alcohol abuse \>2 weeks out will be acceptable for inclusion)

Primary outcomes:
measure: Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM)
timeFrame: Assessed in the tVNS + mindfulness groups and sham + mindfulness groups at Week 2
measure: Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Assessed at the end of the intervention phase (Week 4)
measure: Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS)
timeFrame: Assessed at the end of the intervention phase (Week 4)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Sarah Bottari, M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Liva LaMontagne, Dr. Psych.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02874209: Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting the central and peripheral motor neurons, characterized by the rapidity of its evolution (median survival of 3 years). The pathophysiology of the disease is still poorly understood. Neuronal death results from several cellular mechanisms entangled, including mitochondrial dysfunction. The absence of diagnostic marker causes a significant delay in diagnosis, on average a year. On the other hand, the wish biomarker is important for therapeutic trials. Recently, MRI sodium (23Na) demonstrated its importance to detect noninvasively sodium accumulations associated with neuronal suffering. This neuronal pain can be caused by mitochondrial dysfunction causing the accumulation in the sodium and calcium cell causing neuronal death. These studies were conducted in multiple sclerosis, Alzheimer's disease, Huntington's disease, stroke and brain tumors. They demonstrated that sodium MRI could be an effective and sensitive biomarker for detecting and quantifying neuronal degeneration. The goal of this study is to assess neuronal damage noninvasively by MRI sodium in amyotrophic lateral sclerosis.


Eligibility criteria: Inclusion Criteria:

* Amyotrophic lateral sclerosis patient according to the El Escorial criteria revised Brooks et al. 2000 bulbar or spinal beginning

Exclusion Criteria:

* patient or healthy volonteer presenting MRI contre indications to this exam.
* patient or healthy volonteer presenting severe high blood pressure undergoing medication to treat it or not.
* patient or healthy volonteer having chronic psychiatric illness, dementia

Primary outcomes:
measure: Central conduction time of the potential muscle through transcranial magnetic stimulation
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Masreille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Urielles DESALBRES
role: STUDY_DIRECTOR
affiliation: Assistance Publique Hopitaux De Marseille
name: Aude GRAPPERON, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02376309: The Effect of Nandrolone Decanoate and Leucine on Muscle Loss
Official title: The Effect of Nandrolone Decanoate Injection and Leucine Supplementation on Muscle Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Atrophy
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A decrease in muscle mass can have a profound impact on quality of life, as it can lead to decreased strength, insulin resistance, lower basal metabolic rate and obesity. With this study we investigate whether ingesting leucine or getting a ND injection will reduce the loss of muscle mass and strength.


Eligibility criteria: Inclusion Criteria:

* Healthy men 18-35 years
* BMI between 18.5 and 30 kg/m2

Exclusion Criteria:

- (Family) history of thromboembolic events

* Smoking
* Recent surgery (within 6 months prior to the study)
* Performing progressive resistance training more than three times per week in the past year
* Any back/leg/knee/shoulder complaints which may interfere with the use of crutches
* Current systemic use of corticosteroids, anabolic steroids, growth hormone, testosterone, nandrolone, protein supplements, immunosuppressants or insulin, blood sugar decreasing medication or EPO
* All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis)
* Use of anti-coagulants
* Pre-existing renal disease or those with a potential risk for renal dysfunction (diabetes, hypertension, reduced glomerular filtration rate)
* Liver disease
* Heart failure
* Migraine
* Allergy to nuts or soy
* High blood pressure (\>140 mmHg systolic and \>90 mmHg diastolic) In case of doubt, in- or exclusion of subject will be discussed with responsible physician or principal investigator.

Primary outcomes:
measure: CSA Quadriceps (CT scan)
timeFrame: 7 days
Secondary outcomes:
measure: Muscle strength as measured by 1RM test
timeFrame: 7 days
measure: Muscle fiber type and CSA as measured by histochemistry from the muscle biopsy
timeFrame: 7 days
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre+
state: Limburg
Study officials:
affiliation: Maastricht University
name: Luc van Loon, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06132009: Predictive Value of Preoperative Evaluation in Cases of Recurrent Endometriosis
Official title: Predictive Value of Preoperative Evaluation in Cases of Recurrent Endometriosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Keywords: Endometriosis
prevention & control
preoperative procedures
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-15
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women between the ages of 18-50 who were followed up in our clinic after cystectomy or unilateral oophorectomy due to endometriosis.

Brief summary: To investigate the effect of preoperative evaluation parameters in predicting recurrent disease in women who have undergone cystectomy or unilateral salpingo-oophorectomy due to endometriosis.

Detailed description: Endometriosis is an estrogen-dependent gynecological disease characterized by the presence of endometrial-like tissue outside the uterine cavity, associated with pelvic pain and subfertility. Despite its benign character, endometriosis can recur after surgery and continues to be a disease that disrupts the quality of life of millions of women. This study aimed to examine the risk factors in women who underwent cystectomy or unilateral salpingo-oophorectomy due to endometriosis but had a recurrence. Therefore, the predictive value of parameters such as preoperative biochemical parameters, cyst size and the revised American Society for Reproductive Medicine (rASRM) Scoring system will be examined in recurrent cases.

Eligibility criteria: Inclusion Criteria:

* Women aged 18-50 who had a cystectomy or unilateral oophorectomy due to endometriosis

Exclusion Criteria:

* Women who have had bilateral oophorectomy due to endometriosis
* Malignant conditions
* Smoking
* Women with autoimmune disease

Primary outcomes:
measure: Prediction of endometriosis recurrence
timeFrame: 6-180 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Teaching and Research Hospital
state: Bagcilar
Study officials:
affiliation: Bagcilar Training and Research Hospital
name: Evrim Ebru Kovalak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hidari T, Hirata T, Arakawa T, Koga K, Neriishi K, Fukuda S, Nakazawa A, Nagashima N, Ma S, Sun H, Takamura M, Harada M, Hirota Y, Wada-Hiraike O, Fujii T, Osuga Y. Contralateral ovarian endometrioma recurrence after unilateral salpingo-oophorectomy. BMC Womens Health. 2019 May 2;19(1):59. doi: 10.1186/s12905-019-0760-z.
Clinical trial NCT01080209: Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patients Who Participated in an Intravitreal Brimo PS DDS® Study
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-03-04
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study will evaluate the biodegradation of the brimonidine tartrate posterior segment drug delivery system.


Eligibility criteria: Inclusion Criteria:

* Received the most recent sham or active study treatment of intravitreal Brimo PS DDS® no later than 36 months prior to entry into this study and have either completed their previous study, or have exited early from their previous study for any reason
* Applicable studies: Previous Allergan intravitreal Brimo PS DDS® treatment studies

Exclusion Criteria:

- None

Primary outcomes:
measure: Number of Patients With No Visible Implants in the Study Eye
timeFrame: Month 36
Secondary outcomes:
measure: Number of Patients With Vision Loss in the Study Eye
timeFrame: Baseline of Parent Study, Month 36
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Sydney
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: Brno
country: Czech Republic
city: Paris
country: France
city: Karlsruhe
country: Germany
city: New Delhi
country: India
city: Tel Aviv
country: Israel
city: Udine
country: Italy
city: Seoul
country: Korea, Republic of
city: Makati
country: Philippines
city: Coimbra
country: Portugal
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04280809: Effects of Low-level Laser Therapy After Surgical Removal of Impacted Lower Third Molar
Official title: Postoperative Analgesic and Anti-inflammation Effects of Low-level Laser Therapy After Surgical Removal of Impacted Lower Third Molar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Swelling
Pain
Trismus
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Goal: The aim of this study was to evaluate the effects of low-level laser (LLL) after surgical removal of impacted lower third molars (ILTM).

Detailed description: Goal: The aim of this study was to evaluate the effects of low-level laser (LLL) after surgical removal of impacted lower third molars (ILTM), including pain level, postoperative facial swelling, trismus and non-stimulated saliva secretory immunoglobulin A (sIgA).

Eligibility criteria: Inclusion Criteria:

* had two impacted lower third molars symmetrically in the same position as the classifications of Pell- Gregory and Winter diagnosed by 2D panoramic radiography

Exclusion Criteria:

* Patients with systemic diseases such as cardiovascular disease, hypertension, diabetes mellitus, pregnant, local infections
* refused to participate in the study
* patients who did not follow-up visit would be excluded

Primary outcomes:
measure: Pain degree
timeFrame: at 2 hours after stopping the feeling of numbness lips
measure: Pain degree
timeFrame: at 4 hours after stopping the feeling of numbness lips
measure: Pain degree
timeFrame: at 6 hours after stopping the feeling of numbness lips
measure: Pain degree
timeFrame: at 24 hours after surgery
measure: Pain degree
timeFrame: at 48 hours after surgery
measure: Face swelling degree
timeFrame: on first day after surgery
measure: Face swelling degree
timeFrame: on second day after surgery
measure: Trismus degree
timeFrame: on day 1 postoperatively
measure: Trismus degree
timeFrame: on day 2 postoperatively
measure: sIgA concentration
timeFrame: the second day after surgery
Secondary outcomes:
Other outcomes:
measure: Face swelling degree
timeFrame: before surgery
measure: sIgA concentration
timeFrame: before the surgery
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Faculty of Odonto-Stomatology
state: Dictrict 5
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Ly TB Nguyen, PhD
role: STUDY_DIRECTOR
References:
citation: Le HT, Huynh NC, Nguyen-Ho QA, Nguyen TT, Le SH, Nguyen LT. Effect of Photobiomodulation Therapy on Reducing Acute Pain and Inflammation Following Surgical Removal of Impacted Mandibular Third Molars: A Randomized, Split-Mouth Clinical Trial. Photobiomodul Photomed Laser Surg. 2022 Apr;40(4):245-251. doi: 10.1089/photob.2021.0110. Epub 2022 Mar 29.
Clinical trial NCT06999109: Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress
Official title: Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lupus
Dermatomyositis, Juvenile
Dermatomyositis
Lupus Erythematosus
Lupus Erythematosus, Systemic
Lupus or SLE
Keywords: Stress
Depression
Anxiety
Lupus
Dermatomyositis
Pediatric Rheumatology
Physical Activity
Diet Quality
Sleep
Cardiovascular Health
Health Behaviors
Remote Intervention
Online Intervention
Co-Design
Intervention Refinement
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objectives of this study are to determine if the 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress' (TEAM-LEADS) intervention is feasible and acceptable to adolescents and young adults with lupus and dermatomyositis and whether it can help reduce stress and promote cardiovascular health behaviors in these individuals.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of juvenile-onset systemic lupus erythematosus (JSLE) or dermatomyositis (JDM)
* Age 12-22 years old at time of enrollment

Exclusion Criteria:

* Inability to complete surveys/interviews reliably
* Lack of access to internet-enabled device;
* Non-JSLE/JDM diagnosis
* History of myocardial infarction or cerebrovascular accident
* Evidence of severe emotional distress defined as any of the following at time of screening: a) Patient Health Questionnaire for Adolescents (PHQ9A) score ≥ 15 indicating severe depression; b) PHQ9A suicidality item score \> 0 indicating presence of any suicidal ideation; c) any other evidence noted of severe emotional distress per PI's judgment.

Primary outcomes:
measure: Change in Patient-Reported Outcome Measures Information System (PROMIS) Pediatric Psychological Stress Experiences (version 1.0 Short Form 8a) T-scores
timeFrame: From T1 (baseline visit, day 0) to T3 (Day 84)
Secondary outcomes:
measure: Change in Cardiovascular Health Behaviors Score
timeFrame: From T1 (baseline visit, day 0) to T3 (Day 84)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Kaveh Ardalan, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ardalan K, Lloyd-Jones DM, Schanberg LE. Cardiovascular Health in Pediatric Rheumatologic Diseases. Rheum Dis Clin North Am. 2022 Feb;48(1):157-181. doi: 10.1016/j.rdc.2021.09.006. Epub 2021 Oct 29.
Clinical trial NCT01704209: Collagen Injections for the Treatment of Acne Scars and Wrinkles
Official title: Pilot Study of Autologous Fibroblast Injection for Acne Scars, Forehead Lines, Lip Lines, Horizontal Neck Lines, and Static Crow's Feet
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acne Scars
Wrinkles
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if autologous (your own) fibroblast injections are effective for the treatment of acne scars and wrinkles.


Eligibility criteria: Inclusion Criteria:

* Age 18 or over
* Bilateral acne scars or have moderate to severe wrinkles
* Subjects in good health
* Subjects has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or lactation
* recent Accutane use in the past 6 months
* prone to hypertrophic and keloidal scarring
* have excessively redundant skin in the treatment area or wrinkles longer than 20 cm total
* have a history of autoimmune disorders, organ transplantation, cancer not in remission, active or chronic skin disease
* have a history of basal-cell carcinoma
* have previously received autologous fibroblast treatment
* have undergone any confounding therapy in the lower two-thirds of the face within 1 year or any investigational treatment within 30 days.
* have an allergy to collagen, bovine products, local anesthetics, gentamicin, or amphotericin B
* subjects who are unable to understand the protocol or to give informed consent
* subjects with mental illness

Primary outcomes:
measure: Change from baseline of rater's comparisons at 6 months
timeFrame: Basline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03663309: Assessment of Adherence to Gluten Free Diet in Children and Adolescents by Detection of Gluten in Faecal Samples.
Official title: Assessment of Adherence to Gluten Free Diet in Children and Adolescents by Detection of Gluten Immunogenic Peptides in Faecal Samples and Nutritional Assessment. Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease in Children
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 194
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Children and adolescents aged 2-17 years, reported to be on gluten free diet for at least a year, diagnosed with celiac disease
2. Children and adolescents aged 2-17 years that are reported to be noncompliant with gluten free diet, diagnosed with celiac disease for at least 1 year.
3. Healthy controls aged 2-17 years old matched for age and sex.

Brief summary: To assess the adherence to gluten free diet by measuring faecal and urinary gluten immunogenic peptides (GIP). This will provide an objective measure for adherence.

Detailed description: The adherence to the GFD can be assessed through a dietary interview performed by a registered dietitian or patient self-reports, mucosal healing, assessed by a small bowel biopsy or CD serological screening tests showing decreasing levels of antibodies. However, none of these methods offer an accurate measure of dietary compliance. A novel method to monitor the adherence to the GFD by detection of immune-dominant gluten peptides in human faeces or urine using the anti-α -gliadin G12 antibody was described recently in the literature. Gluten peptides, in particular peptides equivalent to the immunogenic - α -gliadin-33-mer peptide, are resistant to gastrointestinal digestion and that ensures a significant amount of the ingested gluten is excreted in faeces. Consequently, recovery of detectable amounts of the immunogenic fraction in faeces or urine indicates that gluten has passed through the digestive tract, and in the case of urine was absorbed, and, therefore, that gluten has been consumed .

Eligibility criteria: Inclusion Criteria:

* Age 2-17 years.
* Either diagnosis of celiac disease or, in controls, no systemic disease or inflammation
* For all groups parents will provide informed consent.

Exclusion Criteria:

° Children with suspected or known inflammatory bowel disease or other gastrointestinal or systemic diseases.

Primary outcomes:
measure: Correlation between fecal gluten peptides and nutritional assessment for gluten free diet, and correlation with celiac serology.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Rabin Medical Center
name: Liron Mondshine, B.Sc
role: STUDY_CHAIR
References: