louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06140030: Mindfulness Training in Adolescents With Type 1 Diabetes
Official title: Mindfulness-based Stress Reduction in Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Type 1 Diabetes
Quality of Life
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2023-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Creation of an adaptation of a mindfulness-based stress reduction mobile health application specifically designed for adolescents living with Type 1 diabetes. Aim to determine whether daily mindfulness improves anxiety symptoms in adolescents with Type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Type 1 diabetes for 6 months or longer
* Anxiety score of 5 or higher on the Generalized Anxiety Disorder 7-item scale
* Must be able to read and speak English

Exclusion Criteria:

* Clinical diagnosis of a chronic medical condition requiring intensive daily management

Primary outcomes:
measure: Anxiety Symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Diabetes-specific quality of life
timeFrame: 12 weeks
measure: Glycemic control
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida College of Nursing
state: Florida
Study officials:
References:
Clinical trial NCT05610930: Is a Front-of-package Label Contaning Information on Both Nutrient Profile and Ultra-processing Well Understood?
Official title: Effect of a New Graphically Modified Nutri-Score on the Objective Understanding of Foods' Nutritional Quality and Ultra-processing - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Objective Understanding of Nutritional Label
Lead sponsor: University of Paris 13
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 21159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A modified version of the Nutri-Score (Nutri-Score 2.0), containing an additional graphic mention when the product is ultra-processed, has been proposed. The investigators aim to study, in a randomised controlled trial design nested in the NutriNet-Santé cohort, the impact of this modified version on the objective understanding of foods' nutritional quality, and on the identification of UPFs as primary outcomes. They also aim to study as secondary outcomes the impact of this label on purchasing intentions and the product perceived as the healthiest.

Detailed description: Two arms will be enrolled. The control arm will not have access to any FOP Label (the current situation in Europe), and the experimental arm will have access to Nutri-Score 2.0. Participants of both arms wil be asked to rank food products of 3 categories (breakfast cereals, cookies, ready-to-eat meals) according to their nutrient profile, and to identify ultra-processed foods.

Eligibility criteria: Inclusion Criteria:

Enrolled in the NutriNet-Santé cohort

Exclusion Criteria:

None

Primary outcomes:
measure: Objective understanding the nutritional quality.
timeFrame: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
measure: Objective understanding the ultra-processing dimension.
timeFrame: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
Secondary outcomes:
measure: Purchasing intentions
timeFrame: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
measure: Product perceived as the healthiest
timeFrame: Between 30 minutes and 1 hour (the time needed to fill the questionnaire)
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Equipe de recherche en Epidémiologie nutritionnelle
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Bernard Srour, PhD, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05062330: The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease
Official title: The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-30
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease


Eligibility criteria: Inclusion Criteria:

* 18 years of age (either gender and any race);
* Reported history of dry eye for at least 6 months prior to Visit 1;
* Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria:

* Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
* Eye drop use within 2 hours of Visit 1;
* Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of Visit 1;
* Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period;
* Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
* Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1

Primary outcomes:
measure: Schirmer Test Mean Change From Baseline
timeFrame: The efficacy assessment period was before and after the final dose on Day 1 (Dose 4). Baseline was approximately two weeks before dosing at Screening.
measure: Number of Subject Eyes That Are Schirmer Test Responders
timeFrame: The efficacy assessment period was before and after the final dose on Day 1 (Dose 4). Baseline was approximately two weeks before dosing at Screening.
Secondary outcomes:
Other outcomes:
Locations:
city: Raynham
country: United States
facility: Andover Eye Associates (Raynham)
state: Massachusetts
Study officials:
References:
Clinical trial NCT04869930: Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
Official title: Establishing a Diagnostic and Therapeutic Index in Autism Spectrum Disorder (ASD) and Fragile X Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Fra(X) Syndrome
Lead sponsor: Nova Mentis Life Science Corp
Sponsor class: INDUSTRY
Collaborators: name: FourthWall Testing
First posted: 2021-05-03
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Autism Spectrum Disorder (ASD) and Fragile X Syndrome are neurodevelopmental disorders characterized by repetitive behavioral patterns, hypersensitivity, and persistent deficits in social communication. ASD is currently diagnosed exclusively on the basis of neurobehavioral patterning - an approach that (1) cannot distinguish subtle differences between ASD subtypes, (2) is subject to observer bias, and (3) introduces uncertainty regarding root causes and response to treatments. Developmental disorders are often accompanied by various co-occurring medical conditions like gastrointestinal dysfunction or anemia, which can be leveraged to sub-segment the autisms spectrum and improve diagnostics and treatment. Further investigation is needed to define the degree to which specific comorbidities contribute to behavioral symptomology.

Brief summary: The purpose of this study is to accumulate and quantitatively analyze data on the microbiome, serotonin signaling and genetics, and inflammatory cytokines from patients with Autism Spectrum Disorder and Fragile X Syndrome. Computational analysis of multi-dimensional datasets will be used to establish a "Diagnostic and Therapeutic Index" - an objective set of tools that can help differentiate subtypes of Autism Spectrum Disorder and develop more accurate methods of diagnosis and response to treatment.


Eligibility criteria: Inclusion Criteria:

* Early childhood (pre-diagnosis) OR existing ASD diagnosis (Moderate to Severe)
* Existing FXS diagnosis

Exclusion Criteria:

* Hospitalization
* Enrolled in another clinical study

Primary outcomes:
measure: microbial diversity profile
timeFrame: 2 years
Secondary outcomes:
measure: differences in serotonin levels
timeFrame: 2 years
measure: differential expression of serotonin-related signaling molecules
timeFrame: 2 years
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
Study officials:
affiliation: Nova Mentis Life Science Corp
name: Julia V Perederiy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04387630: Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.
Official title: Neoadjuvant Chemotherapy With or Without Metformin in Early Breast Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Keywords: breast cancer
metformin
anti-tumor immunity
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Metformin is a widely used anti-diabetic drug. Several studies have pointed out a potentially beneficial effect of metformin therapy in diabetic cancer patients. Several studies are investigating the anti-tumor effect of metformin in early breast cancer. However, the enhancing effect of metformin on anti-tumor immunity has only been demonstrated in animal models. This study examines the immune effect of metformin in breast cancer patients treated with preoperative chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically proven breast carcinoma.
* American Society of Anesthesiology (ASA) score I-II.
* Candidate for neoadjuvant chemotherapy as per hospital's protocol.
* Clinically measurable tumor.
* No evidence of distant metastasis.
* Normal renal and liver functions.
* Non-diabetics.

Exclusion Criteria:

* Pregnant or lactating women.
* Metastatic breast cancer patients.
* Patients with hepatic impairment.
* Patients with renal impairment.
* Diabetics.
* Patients unwilling to participate or withdrawing from the trial.
* Psychological/ mental impairment.

Primary outcomes:
measure: Clinical Response rate
timeFrame: at three months from starting therapy.
Secondary outcomes:
Other outcomes:
measure: T-cell cytotoxic markers.
timeFrame: procedure
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Cancer center
Study officials:
affiliation: Mansoura University Faculty of Medicine
name: Osama Hussein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eikawa S, Nishida M, Mizukami S, Yamazaki C, Nakayama E, Udono H. Immune-mediated antitumor effect by type 2 diabetes drug, metformin. Proc Natl Acad Sci U S A. 2015 Feb 10;112(6):1809-14. doi: 10.1073/pnas.1417636112. Epub 2015 Jan 26.
citation: Pearce EL, Walsh MC, Cejas PJ, Harms GM, Shen H, Wang LS, Jones RG, Choi Y. Enhancing CD8 T-cell memory by modulating fatty acid metabolism. Nature. 2009 Jul 2;460(7251):103-7. doi: 10.1038/nature08097. Epub 2009 Jun 3.
citation: Coyle C, Cafferty FH, Vale C, Langley RE. Metformin as an adjuvant treatment for cancer: a systematic review and meta-analysis. Ann Oncol. 2016 Dec;27(12):2184-2195. doi: 10.1093/annonc/mdw410. Epub 2016 Sep 28.
Clinical trial NCT01925430: The Evaluation of a New Sleep Algorithm
Official title: The Evaluation of a New Sleep/Wake State Algorithm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Observational
Sleep
Algorithm
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2013-08-19
Enrollment: 36
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: Volunteers who are employees within a medical device company

Brief summary: A new device is being developed to screen for sleep-breathing disorders. Within this device is a new software algorithm which will determine sleep/wake states. The aim of this study is to evaluate the performance of this new algorithm. This prototype will be compared against a commercially available device which monitors sleep/wake patterns. Volunteers will be asked to wear the prototype and comparative devices for 1-2 nights. The data from both devices will be downloaded after the completion of the study and analysis wil be performed to compare the two recordings.


Eligibility criteria: Inclusion Criteria:

* =\> 18yrs old
* can read and write English
* Provide informed written consent

Exclusion Criteria:

* Unable to participate for the full duration of the study
* An individual who is deemed unsuitable to participate in the opinion of the investigator

Primary outcomes:
measure: Total sleep time
timeFrame: 12 hrs
Secondary outcomes:
measure: Frequency of arousals during sleep
timeFrame: 12 hrs
measure: Duration of arousals during sleep
timeFrame: 12 hrs
measure: Occurrence of arousals during sleep
timeFrame: 12 hrs
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: RedMed Ltd
state: New South Wales
Study officials:
affiliation: The University of New South Wales, Australia & ResMed Ltd
name: Klaus Schindhelm, BE PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00782730: Assessment of Third Trimester Post-void Residual and Validation of Bladder Scanner in Pregnancy and Post-partum
Official title: Assessment of Third Trimester Post-void Residual Along With Determining Validity of the Bladder Scanner in the Third Trimester of Pregnancy and Postpartum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: bladder volume measurement
pregnancy
bladder function
Postvoid residual volume assessment
Bladder volumes
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients undergoing elective or non-emergent Cesarean delivery will be asked to enroll. Also adult patients having a labor epidural placed during labor will be asked to participate.

Brief summary: This will be a descriptive study measuring the post-void residual of patients in the third trimester and postpartum. Also, bladder scan values will be compared to the amount of urine obtained from a Foley catheter to determine the accuracy of the bladder scanner in the third trimester and postpartum.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years.
* Having a non-emergent Cesarean Delivery or labor epidural placed.

Exclusion Criteria:

* Age less than 18 years.
* Emergent Cesarean delivery.
* No epidural labor analgesia.

Primary outcomes:
measure: Define normal post-void residual volume in third trimester pregnancy and post-partum.
timeFrame: 12-24 hours
Secondary outcomes:
measure: Calculate the validity of measurements form the bladder scanner ultrasound for bladder volumes during the third trimester of pregnancy and post-partum.
timeFrame: 12-24 hours
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Michael L Stitely, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06739330: Thyroid Dysfunction and Its Association With Metabolic Dysfunction-Associated Fatty Liver Disease
Official title: Thyroid Dysfunction and Its Association With Metabolic Dysfunction-Associated Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Dysfunction
Metabolic Dysfunction-Associated Fatty Liver Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cross-sectional case-control study will be carried out on 150 patients with metabolic dysfunction-associated fatty liver disease (MAFLD) at Tanta University Hospitals for a period from October 2024 to April 2025 after approval from the Institutional Ethical Committee.

Brief summary: This study aims to evaluate the prevalence of thyroid dysfunction and its association with metabolic dysfunction-associated fatty liver disease.

Detailed description: One of the most common causes of chronic liver diseases worldwide is metabolic dysfunction-associated fatty liver disease (MAFLD), which affects about 30% of adults. Thyroid hormones are critical in maintaining metabolic homeostasis throughout life and are intimately linked to the liver.

Dysfunctions of the thyroid gland have been implicated as one of the most important risk factors of MAFLD due to its important role in the hepatic synthesis of fatty acid and cholesterol. Maintaining liver metabolism requires thyroid function to be normal, while thyroid disorders may lead to liver disease progression.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* Patients with metabolic dysfunction-associated fatty liver disease (MAFLD).

Exclusion Criteria:

* History of thyroid disease or treatment (e.g., thyroid nodules, thyroid cancer, hypothyroidism, and hyperthyroidism).
* Patients with alcoholic liver disease take more than 40g of alcohol (or four units) per day.
* Viral hepatitis.
* Pregnant women.

Primary outcomes:
measure: Level of free triiodothyronine (FT3)
timeFrame: After the sample is taken (up to 5 minutes)
Secondary outcomes:
measure: Level of free thyroxine (FT4)
timeFrame: After the sample is taken (up to 5 minutes)
measure: Level of thyroid stimulating hormone
timeFrame: After the sample is taken (up to 5 minutes)
measure: Relation between gender and thyroid function
timeFrame: After the sample is taken (up to 5 minutes)
measure: Correlation between metabolic data and thyroid function tests
timeFrame: After the sample is taken (up to 5 minutes)
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT02130830: Topical Anesthesia Versus Placebo to Decrease Pain in Rubber Band Ligation for Treatment of Internal Hemorrhoids
Official title: Topical Anesthesia Versus Placebo to Decrease Post Procedure Pain in Rubber Band Ligation for the Treatment of Grade I - III Symptomatic Internal Hemorrhoids. A Single Institution, Double Blinded, Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemorrhoids
Pain
Keywords: hemorrhoids
Rubber band ligation
pain
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 80
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: Rubber band ligation is a simple and effective procedure for the management of hemorrhoidal disease. However, 90% of patients have some degree of discomfort associated with the procedure and up to 40% develop clinically significant pain. Some studies have used local anesthesia to reduce pain with promising results, but the use of topical anesthesia has not been reported before.

The investigators hypothesize that the use of topical anesthesia before rubber band ligation significantly reduces post procedure pain.


Eligibility criteria: Inclusion Criteria:

* Symptomatic grade I - III hemorrhoidal disease

Exclusion Criteria:

* Chronic liver disease
* Use of class 3 antiarrythmics
* Coagulopathy
* Grade IV hemorrhoidal disease
* Inflammatory bowel disease
* Pregnancy

Primary outcomes:
measure: Pain measured in analog visual scale
timeFrame: up to 72 hours post procedure
Secondary outcomes:
measure: Procedure morbidity
timeFrame: up to 30 days post procedure
Other outcomes:
measure: Pain measured in visual analog scale in subgroups
timeFrame: up to 72 hours
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad Católica de Chile
state: Región Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Gellona Jose, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pontificia Universidad Catolica de Chile
name: Bellolio Felipe, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01296230: Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?
Official title: Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Varicocele
Infertility
Semen Quality
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2011-02-15
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if the pre-operative levels of sex-hormones can be used to identify the varicocele patients who can expect improvements in their semen parameters following varicocelectomy.


Eligibility criteria: Inclusion Criteria:

* Varicocele (grade 1-3) and surgery planned for this condition
* At least 18 years of age

Exclusion Criteria:

* Fever within 3 months before the first semen sample
* Malformations of the uro-genital tract
* Karyotype other than 46, XY or Y micro deletions
* Endocrine disease
* Chronic disease
* Medications which reduce semen quality
* Epididymitis within 6 months before surgery

Primary outcomes:
measure: Change in semen parameters
timeFrame: February 2017 (anticipated duration of the study)
Secondary outcomes:
measure: Change in hormone levels
timeFrame: February 2017 (anticipated end of the study)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University Department of Growth and Reproduction GR, Section 5064, Rigshospitalet
city: Herlev
country: Denmark
facility: Department of Urology, Herlev Hospital
Study officials:
References: