louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02687659: TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity
Official title: TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Sedentary
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Toulouse
name: MEDES Institut de Médecine et de Physiologie Spatiales, Toulouse
First posted: 2016-02-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Physical inactivity is a major public health issue. Prescription of physical activity appears necessary in some situation with cardiovascular risk. It is important to both qualify and quantify daily physical activity.

The aim of this project is to evaluate the TEMIS system (based on a smart T-shirt) performance in 12 healthy subjects, wearing this system over the daytime during one week.

Detailed description: Healthy subjects have to make different physical activities, wearing the TEMIS system like slow and fast walking, biking, running.

Eligibility criteria: Inclusion Criteria:

* Men or women 18 - 50 yo
* BMI between 18 and 30
* Without chronic disease or chronic treatment (oral contraception is allowed)
* Normal electrocardiogram
* Able to do all the specified physical activity requested by the protocol
* Able to use smart phone and computers
* With access to WIFI, bicycle, and car
* Living in the close area
* Affiliated to public health insurance

Exclusion Criteria:

* Severe allergia
* Severe skin lesions at the thorax level
* Not able to use correctly the TEMIS system
* Will take plane during the week of evaluation
* Under protection

Primary outcomes:
measure: concordance (kappa score) between actual and estimated physical activity
timeFrame: One week (average of each day recording)
Secondary outcomes:
measure: total duration of recording in hours
timeFrame: One week (sum of each day recording)
measure: number of subjects with adverse events
timeFrame: one week
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
state: Maine et Loire
Study officials:
affiliation: University Hospital, Angers
name: Marc-Antoine CUSTAUD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03970759: Meta-analysis of Stannous Fluoride and the Effects on Gingival Health
Official title: A Review of Meta-Analyses on Bioavailable Stannous Fluoride Dentifrices: Effects on Gingival Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2019-06-03
Enrollment: 2890
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This meta-analysis includes healthy adult male and females with mild-moderate gingivitis.

Brief summary: The aim of this 18 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices when used up to 3 months on gingivitis relative to a positive or negative control dentifrice.


Eligibility criteria: Subjects were excluded from this study for the following reasons;

* pregnancy,
* rampant caries,
* severe periodontitis,
* at discretionary of the Principal Investigator.

Primary outcomes:
measure: Number of Bleeding Sites
timeFrame: Up to 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Multiple P&G Investigation Clinical Sites
state: Ohio
Study officials:
References:
citation: Biesbrock A, He T, DiGennaro J, Zou Y, Ramsey D, Garcia-Godoy F. The effects of bioavailable gluconate chelated stannous fluoride dentifrice on gingival bleeding: Meta-analysis of eighteen randomized controlled trials. J Clin Periodontol. 2019 Dec;46(12):1205-1216. doi: 10.1111/jcpe.13203.
Clinical trial NCT06848959: Development and Application of a Diagnosis and Treatment System for Children's Brain Diseases Based on Knowledge Graphs and Large Models
Official title: Jiangsu Provincial Hospital of Traditional Chinese Medicine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Mental Retardation
Tourette&#39;s Syndrome
Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorders
Lead sponsor: Affiliated Hospital of Nanjing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Childhood encephalopathy

Brief summary: Using the knowledge graph and big model technology of combining Chinese and Western medicine we construct a popularization and prevention system for childhood encephalopathy an assisted decision-making system for childhood encephalopathy and a follow-up tracking question and answer system for childhood encephalopathy patients.


Eligibility criteria: Inclusion Criteria:

* 1. meet diagnostic criteria for CP ID TD ADHD ASD; 2. gender is not limited;

Exclusion Criteria:

* 1. CP ID TD ASD due to chorea hepatomegaly hearing abnormality and pharmacogenetic factors;
* 2. Children with other major mental illnesses (e.g. schizophrenia) or organic diseases (e.g. congenital heart disease);

Primary outcomes:
measure: Childhood Autism Rating Scale
timeFrame: 4 mouths
measure: meridian and acupointological features
timeFrame: 4 mouths
measure: Yale Global Tic Severity Scale
timeFrame: 4 mouths
measure: Gross Motor Function Assessment Scale (GMFM)-88
timeFrame: 4 mouths
measure: Autism Behavior Checklist
timeFrame: 4 mouths
measure: acupuncture point status
timeFrame: 4 mouths
measure: Tongue texture
timeFrame: 4 mouths
measure: Wechsler intelligence scale (WIS)
timeFrame: 4 mouths
measure: Resting heart rate
timeFrame: 4 mouths
measure: blood pressure (systolic, diastolic) after 10 minutes of rest
timeFrame: 4 mouths
measure: Conners Rating Scales
timeFrame: 4 mouths
measure: tongue coating, pulse
timeFrame: 4 mouths
measure: respiratory rate
timeFrame: 4 mouths
measure: Body temperature
timeFrame: 4 mouths
Secondary outcomes:
measure: Saliva
timeFrame: 4 mouths
measure: blood
timeFrame: 4 mouths
measure: Urine
timeFrame: 4 mouths
measure: Faeces
timeFrame: 4 mouths
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine
Study officials:
References:
Clinical trial NCT00763659: Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)
Official title: Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Related Maculopathy
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 172
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy.

Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.


Eligibility criteria: Inclusion Criteria:

* All non- exudative forms of age related maculopathy

Exclusion Criteria:

* Exudative age related maculopathy

Primary outcomes:
measure: Optical density of macular pigment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Department of Ophthalmology, University Hospital
Study officials:
affiliation: University Hospital, Jena
name: Jürgen Strobel, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Jena
name: Jens Dawczynski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawczynski J, Jentsch S, Schweitzer D, Hammer M, Lang GE, Strobel J. Long term effects of lutein, zeaxanthin and omega-3-LCPUFAs supplementation on optical density of macular pigment in AMD patients: the LUTEGA study. Graefes Arch Clin Exp Ophthalmol. 2013 Dec;251(12):2711-23. doi: 10.1007/s00417-013-2376-6. Epub 2013 May 22.
citation: Arnold C, Winter L, Frohlich K, Jentsch S, Dawczynski J, Jahreis G, Bohm V. Macular xanthophylls and omega-3 long-chain polyunsaturated fatty acids in age-related macular degeneration: a randomized trial. JAMA Ophthalmol. 2013 May;131(5):564-72. doi: 10.1001/jamaophthalmol.2013.2851.
Clinical trial NCT00029159: The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome
Official title: The Effects of Androgen, Estrogen, and the Combination of Androgen and Estrogen on Growth Rate and Cognitive Function of Growth Hormone-treated Girls With Turner Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Turner Syndrome
Keywords: Turner syndrome
estrogen
androgen
growth hormone
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2002-01-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to learn whether treatment with an androgen type hormone will improve the visual-spatial problems associated with Turner syndrome, and to evaluate the effect growth hormone, with and without androgen, has on growth.

Detailed description: Turner syndrome is associated with short stature, multiple physical stigmata, absent pubertal development, and increased learning problems. This study is designed to (1) examine the effects of sex steroids (androgen and estrogen) on multiple variables including growth rate, GH binding protein, IGF-I, IGFBP3, and cognitive function in the setting of supplemental growth hormone administration and (2) to investigate any synergistic or additive effects of the androgen and estrogen combination versus each alone, on the above variables.

Eligibility criteria: * Karyotype diagnosis compatible with Turner syndrome, but no presence of any Y material in the peripheral karyotype unless a gonadectomy has been performed;
* Chronological age between 10.0 and 14.9 years;
* Bone age less than or equal to 12 years; and
* No treatment with estrogen, androgen, growth hormone, or any other growth-promoting agents exceeding 12 months, and no treatment with any of these agents in the previous 3 months.

Primary outcomes:
measure: Cognitive function in girls with Turner Syndrome
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health
state: Maryland
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital, 1025 Walnut Street, Suite 726
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Judith L. Ross, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeger MP, Shah K, Kowal K, Cutler GB Jr, Kushner H, Ross JL. Prospective study confirms oxandrolone-associated improvement in height in growth hormone-treated adolescent girls with Turner syndrome. Horm Res Paediatr. 2011;75(1):38-46. doi: 10.1159/000317529. Epub 2010 Aug 20.
Clinical trial NCT06003959: The Effect of Breastfeeding Support System
Official title: The Effect of Breastfeeding Support System on Breast Milk Quantity and Mother-Infant Bonding in Preterm Infants: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Breastfeeding
Breast Milk
Breastfeeding Support System
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to examine the impact of a breastfeeding support system on breast milk production and mother-infant bonding in preterm infants. The sample included 70 preterm infants and their mothers, divided into two groups: 35 in the control group and 35 in the experimental group, all of whom met the study criteria.


Eligibility criteria: Inclusion Criteria:

For the infant:

Gestational age between 30 and 34 weeks Birth weight of 1000 g or more

For the mother:

Age over 18, literate, and able to speak Turkish Willingness to breastfeed and no chronic illness preventing breastfeeding

Exclusion Criteria:

Infants without identification Infants with unstable vital signs Mothers with conditions that prevent breastfeeding

Primary outcomes:
measure: Mother-Infant Attachment Scale
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Sümeyye EKİCİ
Study officials:
References:
Clinical trial NCT05446259: Degenerative Cervical Myelopathy Repository
Official title: Development of a Predictive Outcome Model for Patients With Degenerative Cervical Myelopathy Using Objective Functional and Biological Measures.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Myelopathy
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be those diagnosed with degenerative cervical myelopathy, and those with cervical degenerative disease who do not experience myelopathic symptoms. Participating subjects will be required to sign the approved informed consent.

Brief summary: To create a research repository of patients with known degenerative cervical myelopathy (DCM) and a control cohort of subjects who have non-myelopathic spinal disease. This repository will be used to assess functional and/or biological measures that may allow for improved prediction of symptomatic progression and response to treatment in patients with DCM. In addition, this repository will be used to develop a risk assessment scale to accurately predict functional outcomes following operative management of DCM.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of degenerative cervical myelopathy
* Diagnosis of cervical degenerative disease without myelopathy

Exclusion Criteria:

* None outside or diagnostic requirements and age limits.

Primary outcomes:
measure: Data comparison between DCM and control groups
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References:
Clinical trial NCT04412759: PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS
Official title: PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS - A RANDOMISED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Burn Scar
Burn Second Degree
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 26
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 purpose of this study was to compare two wound dressing products for partial thickness burns in adults.

Detailed description: After being informed about the study, all patients that had given written informed consent underwent screening. If eligible study participants were randomized to be treated wih either the standard dressing of care; pigskin or a microbial cellulose. Dressing were applied within 72 hours after burn injury. Evaluation was done in an open manner due to the specific characteristics of the dressings. Study particpants were followed weekly until complete wound closure and after that evaluated at 6 and 12 months after injruy for burn scar outcome.

Eligibility criteria: Inclusion Criteria:

* Study participants admitted within 72 hours of injury
* partial-thickness burns requiring a temporary skin cover
* written informed consent

Exclusion Criteria:

* severe coexisting cutaneous trauma
* chronic or current skin disease,
* severe cognitive dysfunction or psychiatric disorder
* pregnant or breast feeding women were excluded.

Primary outcomes:
measure: Time to complete healing of the burn
timeFrame: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Secondary outcomes:
measure: Burn wound infection
timeFrame: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
measure: Burn wound pain
timeFrame: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
measure: Duration of hospital stay (LOS)
timeFrame: From admission until discharge, up to 6 months
measure: Burn scar outcome
timeFrame: Evaluated at six and 12 months after injury
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: The Burn Centre at Linköping University Hospital,
Study officials:
References:
Clinical trial NCT06174259: Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients
Official title: Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Locally Advanced Breast Cancer
Intermittent Fasting
Keywords: locally advanced breast cancer
HR positive HER2 negative breast cancer
intermittent fasting
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast cancer is the most common cancer type among women in Egypt and world. Preclinical studies show fasting reduces growth factors and modulates nutrient sensing systems, protecting normal cells against chemotherapy. However, cancer cells are not protected due to Differential Stress Resistance (DSR), making them more vulnerable to chemotherapeutics. This study aims to evaluate intermittent fasting impact on neoadjuvant chemotherapy in breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* Female patients with stage II or III (cT1cN+ or ≥T2 any cN, cM0) breast cancer. - Planned to receive standard neoadjuvant chemotherapy.
* Measurable disease (breast and/or lymph nodes).
* WHO performance status 0-2.
* Being overweight (BMI: 25-29.9 kg/m2) or obese (BMI: ≥30 kg/m2).
* Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
* Adequate liver function: bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
* Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
* Patients must be accessible for treatment and follow-up

Exclusion Criteria:

* Serious diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
* Diabetes Mellitus.
* Pregnancy or lactating
* Any metabolic disorders that may affect gluconeogenesis or adaptation to fasting periods.
* Previous malignancy.
* Using weight loss medication.

Primary outcomes:
measure: pathological response rate
timeFrame: 6months
Secondary outcomes:
measure: The percentage of patients with grade III/IV toxicity
timeFrame: 6 months
measure: Grade I/II side effects of chemotherapy
timeFrame: 6 months
measure: Clinical response
timeFrame: 6months
measure: Body composition changes (fat, muscles, water)
timeFrame: 6 months
measure: Inflammatory response to chemotherapy.
timeFrame: 6 months
measure: Long term efficacy of treatment
timeFrame: 5 years
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia university
state: Menoufia
Study officials:
References:
Clinical trial NCT06367959: Health Benefits of Writing Therapy Among Asian American Cancer Survivors
Official title: Health Benefits of Writing Therapy Among Asian American Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To learn more about participant experience as a Asian American immigrant breast cancer survivor and how writing about participant experiences may affect participant's health.

Detailed description: Primary Objective:

To determine the effects of writing therapy on QOL and perceived stress at the 6- and 12-month follow-ups.

Secondary Objective:

To discover the effects of writing therapy on stress biomarkers and perceived stress at the 3-month follow-up.

To explore the psychosocial and cultural mechanisms responsible for the benefits of writing therapy by using mixed methods.

Eligibility criteria: Inclusion Criteria:

* Adult (aged 18 and older) diagnosed with stage 0-III cancer (or acute leukemia in remission/ chronic myeloid leukemia in chronic phase).
* Self-identified as Asian, Asian Americans, any Asian or Asian American subgroup (Chinese, Vietnamese, Indian, Korean, etc.) ethnic/cultural background
* Completed primary treatment, including surgery, chemotherapy, and/or radiation therapy, immunotherapy, or targeted therapy within the preceding 5 years.
* Comfortable reading in English or in Chinese.

Exclusion Criteria:

- Inability to provide informed consent.

Primary outcomes:
measure: Primary Outcome Measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: Time Frame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Qian Lu, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: