louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04988594: Effects of Yogurt With Probiotics in Adults With Type 2 Diabetes Mellitus
Official title: A 12-weeks Double Blind Trial of Effects of Yogurt With Probiotics in Adults With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: probiotics
glucose homeostasis
Lead sponsor: Faculty of Medical Sciences, Clinical Hospital
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 46
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to analyze the effects of the consumption of yogurt with concentrated and lyophilized probiotic cultures on the parameters associated with glucose homeostasis, inflammation and oxidative stress in patients with Type 2 Diabetes Mellitus (T2DM).

Detailed description: After being informed about the study and the potential risks, all patients who gave their written informed consent underwent a screening period of 1 week to determine their eligibility to participate in the study. At week 0, patients who met the eligibility requirements were randomized in a double-blind manner (participant and investigator) to the American Diabetes Association (ADA) diet + yogurt with premium probiotics (300 g/d) or ADA diet + conventional yogurt (300 g/d) or ADA diet without fermented dairy.

Eligibility criteria: Inclusion Criteria:

* Patients with T2DM diagnosed at least one year ago.
* That they are outpatients.
* Between 25 and 65 years old.

Exclusion Criteria:

* Smoking patients.
* Lactose intolerance.
* Pregnancy or breastfeeding.
* Presence of kidney, liver, immunodeficiency, inflammatory bowel disease or thyroid disorder.
* Use of insulin, estrogen, progesterone or diuretic injections.
* Consumption of probiotic supplements two months before the start of the study

Primary outcomes:
measure: Changes from baseline in parameters associated with glucose homeostasis
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Changes in inflammatory parameters
timeFrame: Baseline and week 12
measure: Changes in oxidative stress parameters
timeFrame: Baseline and week 12
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Instituto Maimonides de Investigacion Biomedica de Cordoba
Study officials:
affiliation: Instituto Maimonides de Investigacion Biomedica de Cordoba, Spain
name: Pablo Perez Martinez, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medical Science, Paraguay
name: Maria Ruiz Diaz Narvaez, DN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06412094: Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis
Official title: A Comparative Controlled Study of the Effectiveness of Using a Mobile Application in Managing Pediatric Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Avanta Trading Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-14
Enrollment: 66
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized controlled study in children with AD, divided into three groups: a control group without access to the app, an experimental observational group with the app, and an experimental interventional group with potential investigator supervision. Outcome measures included the SCORAD and the POEM scores.

Detailed description: Three study groups: a control group that did not use the mobile health Atopic App, an experimental observational group provided with the mobile app without supervision by the investigators and experimental interventional group provided with the mobile app with potential supervision by the investigators. Upon study enrollment, participants receive recommended treatment plans and instructions for contacting the doctor via messenger for any questions during treatment. Virtual oversight disclosed to participant of the intervention arm, including registration status and regularity of use of the app.

Outcome endpoints are objective severity assessment using the SCORAD scale, and subjective assessment of effectiveness using the POEM scale.

Eligibility criteria: Inclusion Criteria:

* Children with AD and their parents that provided an informed consent to participate in the study

Exclusion Criteria:

* previous experience with the Atopic App
* participation in affiliated online Atopic School program
* presence of concomitant skin disease or pathological conditions that may affect the assessment of effectiveness (severe somatic diseases, mental disorders, oncologic or acute infectious diseases, etc.)
* avoidance from registration during consecutive 5 days following the screening visit (for participants in groups 2 or 3,)

Primary outcomes:
measure: Patient Oriented Eczema Measure (POEM)
timeFrame: At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2).
measure: SCORAD (SCORing Atopic Dermatitis)
timeFrame: At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2).
Secondary outcomes:
Other outcomes:
Locations:
city: Samara
country: Russian Federation
facility: Samara State Medical University
Study officials:
affiliation: Samara State Medical University
name: Natalia Migacheva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06258694: Venous Thrombo-Embolism Imaging Database (VTE-ID)
Official title: Venous Thrombo-Embolism Imaging Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Deep Vein Thrombosis
Pulmonary Embolism
Keywords: Venous thromboembolism
Image processing
Radiomics
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 2208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patients included in the EDITH cohort between November 2009 and Novembre 2019, with a confirmed diagnosis of VTE.

Brief summary: The purpose of this study is to identify and validate new imaging biomarkers allowing an individual phenotyping of patient with venous thrombo-embolism (VTE), mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. To do so, the investigators will create a retrospective imaging database including multiple imaging modalities, performed at diagnosis of the VTE.

Detailed description: Using a large imaging data in VTE (including ultrasound, CT-scan and Ventilation/Perfusion lung scan), the investigators will search for association between imaging data and VTE phenotypes, mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. Then, using a radiomic approach, the investigators will try to identify new imaging biomarkers able to provide an individual phenotyping in these patients.

These imaging biomarkers will be validated using an internal cross validation technique.

Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Confirmed VTE diagnosis (deep vein thrombosis or pulmonary embolism).
* Inclusion in the EDITH (Etude des Déterminants et Interaction de la THrombose veineuse) between November 2009 and November 2019.
* No opposition to be included in the present study.

Exclusion Criteria:

* Patients under 18 years old.
* Patients under judicial protection.
* Patient physically or cognitively unable to give consent.
* Refusal to participate.

Primary outcomes:
measure: VTE recurrence
timeFrame: At enrollment (retrospective follow up to 2 years)
measure: Distinguishing provoked from unprovoked VTE
timeFrame: At enrollment
Secondary outcomes:
measure: Individual phenotyping
timeFrame: At enrollment
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
state: Finistere
Study officials:
References:
Clinical trial NCT06035094: An Exercise Intervention to Improve Overall Brain Health
Official title: An Exercise Intervention to Improve Overall Brain Health: PEDAL (Physical Education for an Active Lifestyle) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Care Score
Exercise
Hypertension
BMI
Keywords: Brain health
brain care score
exercise
hypertension
overweight
obesity
BMI
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test the effects of 10 weeks of exercise on overall brain health, reduction in blood pressure, and the number of blood vessels in the back of the eyes in patients with hypertension and have a body mass index ≥ 25 kg/m2. The main question\[s\] it aims to answer are:

* To test the effect of moderate vs intensive exercise on Brain Care Score outcomes.
* To ascertain the differential impact of moderate vs high intensity exercise in reducing hypertension and its downstream effects.


Eligibility criteria: Inclusion Criteria:

* diagnosed with hypertension
* have a body mass index ≥ 25 kg/m2
* are between the ages of 35-65 years old
* access to a smart phone that allows installation of 2 two applications that record your workouts
* pass a fitness evaluation.

Exclusion Criteria:

* do not have hypertension
* weight over 300 lbs
* unable to pass the fitness evaluation
* BMI less than 25kg/m2

Primary outcomes:
measure: Improved overall Brain Care Score metric.
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Pamela G. Bowen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01884194: Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging
Official title: Morphological Analysis of the Pineal Gland in Pediatric Retinoblastoma Patients Using Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinoblastoma
Pineoblastoma
Keywords: retinoblastoma
pineoblastoma
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients with retinoblastoma

Brief summary: MRI is useful for diagnosing pinealoblastoma in retinoblastoma patients


Eligibility criteria: Inclusion Criteria:

* diagnosis of retinoblastoma
* brain MRI available

Exclusion Criteria:

* insufficient quality of brain MRI

Primary outcomes:
measure: Malignancy criteria of pineal gland
timeFrame: clinical follow-up 1-year after baseline imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Hospital Berlin
Study officials:
References:
citation: Pham TT, Siebert E, Asbach P, Willerding G, Erb-Eigner K. Magnetic resonance imaging based morphologic evaluation of the pineal gland for suspected pineoblastoma in retinoblastoma patients and age-matched controls. J Neurol Sci. 2015 Dec 15;359(1-2):185-92. doi: 10.1016/j.jns.2015.10.046. Epub 2015 Oct 28.
Clinical trial NCT00502294: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Intravenous Steroid-Refractory Ulcerative Colitis
Keywords: Ulcerative Colitis, UC, Intravenous Steroid-Refractory Ulcerative Colitis, IVSR-UC
Lead sponsor: Facet Biotech
Sponsor class: INDUSTRY
Collaborators: name: PDL BioPharma, Inc.
First posted: 2007-07-17
Enrollment: 150
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: To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years of age or older.
* Diagnosis of UC verified by endoscopy within 60 months prior to consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06756594: Efficacy of Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation
Official title: Efficacy of Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation During Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Propofol
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study aims to compare efficacy of sedation between Dexmedetomidine-Propofol and Ketamine-Propofol combinations in the upper or lower gastrointestinal system endoscopy. We compare between 2 combinations as regard hemodynamic stability, post operative side effects as occurrence of delirium, nausea, vomiting, headache, hallucination or agitation.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I to II.
* Age between 18 and 60 years.
* Both sexes.

Exclusion Criteria:

* Having severe heart, lung, liver disease, kidney failure, or bleeding disorder.
* Patients having fever, hypothermia or infection, electrolyte disorders, such as hypokalemia and hypocalcaemia, acid-base disorder, allergy to drugs to be used.

Primary outcomes:
measure: intraoperative and postoperative monitoring of sedation during upper or lower gastrointestinal system endoscopy.
timeFrame: every 5 minutes intraoperative and every 15 minutes for 2 hours postoperative.
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Tekeli AE, Oguz AK, Tuncdemir YE, Almali N. Comparison of dexmedetomidine-propofol and ketamine-propofol administration during sedation-guided upper gastrointestinal system endoscopy. Medicine (Baltimore). 2020 Dec 4;99(49):e23317. doi: 10.1097/MD.0000000000023317.
citation: Zhang F, Sun HR, Zheng ZB, Liao R, Liu J. Dexmedetomidine versus midazolam for sedation during endoscopy: A meta-analysis. Exp Ther Med. 2016 Jun;11(6):2519-2524. doi: 10.3892/etm.2016.3186. Epub 2016 Mar 24.
citation: Chang ET, Certal V, Song SA, Zaghi S, Carrasco-Llatas M, Torre C, Capasso R, Camacho M. Dexmedetomidine versus propofol during drug-induced sleep endoscopy and sedation: a systematic review. Sleep Breath. 2017 Sep;21(3):727-735. doi: 10.1007/s11325-017-1465-x. Epub 2017 Jan 27.
Clinical trial NCT02866994: Project Connect Online: An Internet-based Intervention for Women With Breast Cancer
Official title: Project Connect: Enhancing Connections During Metastatic Breast Cancer (PCO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Women
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
name: Breast Cancer Research Foundation
First posted: 2016-08-15
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized comparative effectiveness trial examines the potential psychosocial and physical health-related benefits of sharing personal websites with other women with breast cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family and friends only (PCO condition) in a sample of women with metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* women at least 18 years of age;
* first diagnosis of Stage IV breast cancer or a recurrent diagnosis of metastatic breast cancer, any interval since diagnosis;
* ability to complete the intervention and assessments in English; and
* willingness to attend in-person PCO workshop;

Exclusion Criteria:

* male (because men constitute less than 1% of breast cancer patients, numbers would not be sufficient for reliable analyses);
* local (i.e., same breast, surgical scar, chest wall) or regional (i.e., lymph nodes) recurrent disease; and
* use of a personal website to post cancer-relevant material in the past six months

Primary outcomes:
measure: Change of general and cancer-related psychological status
timeFrame: Baseline, 2 months, 4 months
Secondary outcomes:
measure: Change in overall physical health status
timeFrame: Baseline, 2 months, 4 months
Other outcomes:
measure: Psychological mediator and moderator assessment
timeFrame: Baseline, 2 months, 4 months
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: Proffessor and Director, Health Policy & Management
name: Patricia Ganz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02566694: Analysis of Specimens From Patients With Orthopaedic Implants
Official title: Analysis of Specimens From Patients With Orthopaedic Implants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Implants
Lead sponsor: Royal National Orthopaedic Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Coxa, Hospital for Joint Replacement
First posted: 2015-10-02
Enrollment: 200
Sex: ALL
Minimum age (years): 11
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be both male and female, aged between 11-70 years.

Brief summary: The investigators aim to determine the cause of failure of orthopaedic implants using multi-disciplinary analysis of data from patients who have undergone revision.

Detailed description: The following tests will then be arranged:

* Tribological assessment. The investigators will measure the wear of the explants using: 1) 'out of roundness'; and 2) Coordinate measuring. Semi-quantitative assessment of damage to the explants will also be conducted
* Histological assessment. Tissue sent in formalin may determine the biomarker of diagnosis of metal ion synovitis where applicable
* Metal ion measurement in body fluids where applicable (in patients with metal implants)
* Diamond Light Source (this was approved in the 1st amendment). The tests will involve subjecting formalin fixed tissue to the high energy electron beam of the Diamond Light Source
* Destructive testing of the implant is allowed by the patient (after all non-destructive tests have been performed)
* Protein analysis of fluid and tissue if provided
* Titanium levels from blood samples if provided
* Gene expression testing to assess and understand mechanism of inflammation where applicable

Eligibility criteria: Inclusion Criteria:

* All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants)

Exclusion Criteria:

* Patients not consenting to the study

Primary outcomes:
measure: Cause of failure
timeFrame: At time of failure which is likely to be an average of 5 years post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Stanmore
country: United Kingdom
facility: Royal National Orthopaedic Hospital
state: London
Study officials:
affiliation: RNOH
name: Alister Hart, FRCSG(Orth)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05062694: Physical Therapy Management Of The Patient With Central Sensitization
Official title: Physical Therapy Management Of The Patient With Central Sensitization: An Observational Study Among Italian Physiotherapists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Sensitisation
Musculoskeletal Diseases
Pain
Keywords: Patient Management
Central Sensitisation
Muscoloskeletal Disease
Pain
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physical therapists

Brief summary: In the literature there is still debate about the concept of central sensitization, as a pain mechanism that can support a neuromusculoskeletal pathology and which for Woolf corresponds to an amplification of neural signaling within the Central Nervous System causing hypersensitivity to pain.

This mechanism is often confused with the concept of chronic pain, as in many conditions such as fibromyalgia, traumatic neck pain, low back pain or osteoarthritis, central sensitization supports its maintenance beyond 6 months.

We believe it is important to investigate among Italian physiotherapists the management of the patient in which the presence of a central pain sensitization phenomenon is suspected, in order to provide consistent data to direct the education of health professionals towards more effective management of this problem.

To achieve this goal we aim to:

* Conduct a Delphi study in order to reach consensus, into a panel of experts, on the methods useful for the management, in each phase of the physiotherapy process, of the patient with neuromusculoskeletal problems with pain underlying central sensitization mechanism
* Investigate, through a survey among Italian physiotherapists, their clinical approach to the patient in question
* Develop a free online course available to clinical professionals and/or students who wish to deepen this issue.


Eligibility criteria: Inclusion Criteria:

* Italian physiotherapists who will decide to fill in the questionnaire

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Physical therapists' patient management
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara
state: FE
Study officials:
References: