louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00995475: A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease
Official title: A Proof of Concept Study to Evaluate the Dose Response for the Systemic Benefit Risk Ratio of Inhaled Fluticasone Propionate in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2009-10-15
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers are now an established treatment for COPD. Inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. A previous study in patients with COPD.

C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation. Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP have also been found in patients with COPD. In some studies, steroid inhalers have reduced CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown whether this reflects a reduction in lung inflammation or an effect of systemically absorbed corticosteroid.

It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.


Eligibility criteria: Inclusion Criteria:

* Current or ex-smokers
* Aged over 50years
* FEV1/FVC ratio \<0.7
* FEV1\<80% predicted
* Improvement in FEV1 following short acting beta-agonist not greater than 15% and 200ml.

Exclusion Criteria:

* Diagnosis of asthma, bronchiectasis or ABPA
* Inability to perform study procedures or give informed consent
* Known sensitivity to trial medications

Primary outcomes:
measure: CRP
timeFrame: 4 weeks
Secondary outcomes:
measure: Alveolar Nitric Oxide
timeFrame: 4 weeks
measure: OUCC
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Williamson PA, Menzies D, Clearie KL, Vaidyanathan S, Lipworth BJ. Dose-response for inhaled fluticasone on airway and systemic inflammation in COPD. Eur Respir J. 2011 Jan;37(1):206-9. doi: 10.1183/09031936.00062210. No abstract available.
Clinical trial NCT06556875: Regulation of HIIT Combined with IET on Vascular Function in Young Women with Normal Weight Obesity
Official title: Regulation of HIIT Combined with IET on Vascular Function in Young Women with Normal Weight Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Weight Obesity
Keywords: isometric exercise training
high-intensity interval training
normal weight obesity
vascular fitness
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison of the effects of combined IET with HIIT and HIIT on vascular function in young NWO women.

Detailed description: This is a randomized clinical trial of single-blind with 3 arms (control group , HIIT group and IET with HIIT group), in which a pre-treatment-posttest design has been used.

Eligibility criteria: Inclusion Criteria:

* Female, aged between 18 and 30 years old;
* BMI between 18.5 and 24.9 kg/m2 with a BF% \> 30% (normal weight obesity determination criteria);
* exercise capacity to complete the exercise programme.

Exclusion Criteria:

* Acute or chronic musculoskeletal disorders, cardiovascular diseases, etc. that prevented training;
* other diseases (such as diabetes, etc.) that had a great impact on physical condition;
* bad habits (such as smoking, drinking, etc.);
* and unstable body weight (up and down fluctuations of more than 2.5 kg) in the 3 months before the experiment.

Primary outcomes:
measure: Intima-Media Thickness (IMT)
timeFrame: 8 weeks
measure: Flow-Mediated Dilation (FMD)
timeFrame: 8 weeks
Secondary outcomes:
measure: Body Composition Indicators
timeFrame: 8 weeks
measure: Body Mass Index (BMI)
timeFrame: 8 weeks
measure: Blood Pressure (BP)
timeFrame: 8 weeks
measure: Pulse Wave Velocity (PWV) and ankle brachial index (ABI)
timeFrame: 8 weeks
measure: Volume Oxygen Maximum (VO2max)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: School of Sports Medicine and Rehabilitation, Beijing Sport University
Study officials:
References:
Clinical trial NCT00363675: Evaluation of Hand Assessments in Children With Severe Hand Burns
Official title: Evaluation of Hand Assessments in Children With Severe Hand Burns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burns
Keywords: Hand Burns
Pediatrics
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Shriners Hospitals for Children
First posted: 2006-08-15
Enrollment: 3
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to see if some tests of hand movement, strength, and function are valid for children with burns.

Detailed description: Children will be given a battery of tests to determine the validity of these measures for children with severe hand burns. The tests include:

* Pinch and grip strength;
* Stereognosis;
* Speed of manipulation using the Nine Hole Peg Test, Box \& Blocks Test, and the Moberg Pickup Test;
* Measurement of Range of Motion of the wrist and fingers.

Eligibility criteria: Inclusion Criteria:

* Third degree brns to one or both hands
* All areas closed
* Age between 5 and 18 years old
* English or Spanish speaking

Exclusion Criteria:

* Previous hand condition
* Unable to follow 2 step directions

Primary outcomes:
measure: Blocks & Box (Standardized Test).
timeFrame: Baseline
measure: Range of Motion, Total Active Motion (TAM)
timeFrame: Baseline
measure: Grip Strength
timeFrame: Baseline
measure: Moberg Pickup Test
timeFrame: Seconds to pick up all 12 objects
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Shriners Hospitals for Children - Boston
state: Massachusetts
Study officials:
affiliation: Shriners Hospitals for Children - Boston
name: Mary Jo Baryza, MS, PT, PCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02550275: Social Cognition in Huntington's Disease: Cognitive Study and Functional and Morphological Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Huntington's Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2015-09-15
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Huntington's disease is a rare genetic neurodegenerative disease. It is accompanied by movement disorders, cognitive and behavioral. The social behavior of patients are changed, affecting interpersonal relationships. Patients with Huntington's disease are described as self-centered, lacking sympathy and empathy and mentally inflexible. These behavioral problems can be a major source of anxiety for patients and their families. These disorders also have a negative impact cognitive and motor symptoms as well as the functional abilities and the quality of life of patients and their entourage. Authors have suggested that these problems could be related inter alia to social cognition disorders. This concept refers to a set of skills and emotional and social experiences that regulate relations between individuals and can explain the behavior of individuals and groups. The objective is to evaluate disorders of social cognition, which may account for behavioral changes in Huntington's disease.


Eligibility criteria: Inclusion Criteria:

For all particpipants

* Patient gave its written consent
* between 20 and 70 years
* School level : at least 7 years
* native language: french

For presymptomatic patient

* Huntington's disease diagnosed with abnormal number of CAG repeats: 36 \< nucleotide expansion (CAG)
* Unified Huntington Disease Rating Scale moteur ≤ 5

For symptomatic patient

* Huntington's disease diagnosed with abnormal number of CAG repeats: 36 \< nucleotide expansion (CAG)
* Unified Huntington Disease Rating Scale moteur \> 5

Exclusion Criteria:

* No national health insurance affiliation
* Being under guardianship
* Meeting brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, Renal failure, hypersensitivity of Gadolinium) or refusing MRI
* Pregnant or lactating women
* Patient with involuntary movement hampering the realization of MRI

Primary outcomes:
measure: the achievement of social cognition process in Huntington's disease using the total score of the scale 15-TOM
timeFrame: 3 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital, Angers
name: SCHERER GAGOU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06611475: Prediction of MMSE Scores for Cognitive Impairment
Official title: Prediction of MMSE Scores for Cognitive Impairment: A Machine Learning Analysis of Oral Health and Demographic Data in Individuals Over 60 Years of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Healthy Control
Keywords: Classification
Machine Learning
Mini-Mental State Examination
Cognitive Impairment
Oral Health
Lead sponsor: Blekinge Institute of Technology
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 693
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data collected from the European collaborative study Support Monitoring and Reminder Technology for Mild Dementia (SMART4MD) and the Swedish National Study on Aging and Care (SNAC-B) will be analyzed. Participants aged 60 years or older will be included in the analysis.

Brief summary: This study aims to explore the potential of using machine learning (ML) algorithms to predict cognitive status, specifically MMSE scores, based on oral health and demographic data. The objective is to evaluate the effectiveness of various ML models and identify the most relevant oral health indicators for predicting MMSE scores of 30 (normal cognition) or ≤26 (cognitive impairment) in individuals aged 60 and above.

Detailed description: This cross-sectional study utilizes oral health and demographic data from two existing cohort studies: the European collaborative study Support Monitoring and Reminder Technology for Mild Dementia (SMART4MD) and the Swedish National Study on Aging and Care (SNAC-B). Participants aged 60 years or older will be included in the analysis. The data will be used to develop and evaluate machine learning models for predicting cognitive status.

Objectives:

1. Primary Objective: To assess the potential of oral health parameters for binary classification of MMSE scores (30 vs. ≤26).
2. Secondary Objective: To identify the most influential oral health parameters contributing to cognitive impairment predictions.
3. Tertiary Objective: To compare the performance of Random Forest (RF), Support Vector Machine (SVM), and CatBoost (CB) classifiers in predicting MMSE scores using oral health data.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 60 years or older.
* Participants with recorded oral health parameters and MMSE scores of either 30 or ≤26.

Exclusion Criteria:

* Individuals with MMSE scores of 27, 28, or 29, as these scores represent a transition phase between normal cognition and cognitive impairment, which could introduce variability.
* Individuals younger than 60 years.

Primary outcomes:
measure: Detection perfomance
timeFrame: 5 mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Karlskrona
country: Sweden
facility: Blekinge institute of Technology
Study officials:
References:
Clinical trial NCT06630975: Hemiepiphysiodesis by Eight Plate Versus Osteotomy in the Management of Pediatric Coronal Knee Deformities
Official title: Resident at AlAzhar University Assuit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genu Varum
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 2
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Coronal angular deformities of lower limb in children are a common finding in pediatric orthopedic surgery.These angular deformities can be idiopathic in origin, or they can emerge secondary to congenital and acquired abnormalities. Persistent coronal plane deformities around knee (genu varum/valgum) could lead to meniscal tears, collateral ligament laxity, cartilage degeneration, and early osteoarthritis due to gradual mechanical axis disruption

Detailed description: Eight-Plates first described by Stevens are simple to use .Moreover, owing to the flexible screw/plate connection, fewer complications in terms of implant loosening and fracture can be expected.Good results aswell as low reboundand complication rates have been recorded for the first series of cases

Eligibility criteria: Inclusion Criteria:

* Growth plate still open at Time of Surgery

Exclusion Criteria:

* Epiphyseal plate involved in trauma resulting in a bridging callus formation,

Primary outcomes:
measure: Comparative Study Between Growth Guided Correction By ( 8 Plate ) and Corrective Osteoclasis in Management of Coronal Deformity of Lower Limb in Children
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Mohammad Osama Hamdy
Study officials:
References:
Clinical trial NCT00900575: Cervical Cancer Detection Using Optical Spectroscopy
Official title: Cervical Cancer Detection Using Optical Spectroscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: cervical cancer
LEEP
colposcopy
Pap smear
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-05-13
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.


Eligibility criteria: Inclusion Criteria:

* undergoing colposcopy for the diagnosis of cervical cancer
* LEEP for the treatment of cervical cancer in early stages.
* Follow-up Pap smear in surveillance

Exclusion Criteria:

* Women under the age of 18 (minors) will be excluded from this study.
* patients will be excluded if she has had a recent episode of bleeding or preterm labor.
* Subjects who are not competent to give consent will excluded

Primary outcomes:
measure: Identification of optical signatures of cervical tissue
timeFrame: Day of procedure (less than 10 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Nimmi Ramanujam, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang VT, Cartwright PS, Bean SM, Palmer GM, Bentley RC, Ramanujam N. Quantitative physiology of the precancerous cervix in vivo through optical spectroscopy. Neoplasia. 2009 Apr;11(4):325-32. doi: 10.1593/neo.81386.
citation: Asiedu MN, Agudogo JS, Dotson ME, Skerrett E, Krieger MS, Lam CT, Agyei D, Amewu J, Asah-Opoku K, Huchko M, Schmitt JW, Samba A, Srofenyoh E, Ramanujam N. A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system. Sci Rep. 2020 Oct 6;10(1):16570. doi: 10.1038/s41598-020-72219-9.
Clinical trial NCT02706275: Pilot Trial of External Warming in Septic Patients
Official title: Pilot Randomized Trial of External Warming in Critically Ill Adult Septic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 60
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 is to determine whether externally warming critically ill afebrile adult septic patients will improve indices of immune function and/or clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Admitted to a surgical or medical intensive care unit
* Age greater than 18 years
* Diagnosis of sepsis within 24 hours of enrollment
* Requirement for mechanical ventilation with expected duration of mechanical ventilation \> 48 hours
* Goal Richmond Agitation Sedation Scale (RASS) \< 0
* Maximum baseline temperature (within previous 24 hours) \< 38.3°C

Exclusion Criteria:

* Treatment with chemotherapy within 6 months of enrollment
* Treatment with corticosteroids at a dose \> 300 mg/day hydrocortisone (or equivalent)
* History of solid organ transplant on any immunosuppression medication
* History of immunological disease
* History of chronic infection with hepatitis B or C virus
* History of acute stroke, acute coronary syndrome, or severe head injury requiring osmotic therapy within 7 days prior to enrollment
* History of multiple sclerosis
* Contraindications to both bladder or esophageal core temperature monitors or to forced air warming blankets
* Moribund status
* Sepsis without source control

Primary outcomes:
measure: Monocyte human leukocyte antigen (mHLA-DR) expression
timeFrame: 48 hours hours following the start of the intervention period
Secondary outcomes:
measure: Interferon (IFN)-gamma production
timeFrame: 48 hours following the start of the intervention period
measure: Number of patients who acquire nosocomial infections
timeFrame: 30 days after diagnosis of sepsis
measure: Mortality
timeFrame: 28 days
measure: Number of patients in whom the intervention is stopped early secondary to hemodynamic changes related to the intervention
timeFrame: Through study completion, 2 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
citation: Drewry AM, Mohr NM, Ablordeppey EA, Dalton CM, Doctor RJ, Fuller BM, Kollef MH, Hotchkiss RS. Therapeutic Hyperthermia Is Associated With Improved Survival in Afebrile Critically Ill Patients With Sepsis: A Pilot Randomized Trial. Crit Care Med. 2022 Jun 1;50(6):924-934. doi: 10.1097/CCM.0000000000005470. Epub 2022 Feb 7.
Clinical trial NCT00243659: Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
Official title: An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemophilia A
Keywords: Hemophilia A
bleeding disorder
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-24
Enrollment: 30
Sex: MALE
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI).


Eligibility criteria: * Male, at least 12 years old, with severe hemophilia A undergoing major elective major surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test at screening and no past history of inhibitor.
* Previously treated with at least 150 exposure days to any Factor VIII product
* Normal hepatic and renal function tests and no other bleeding disorder

Primary outcomes:
measure: Number of Patients Who Achieved Hemostatic Efficacy After Surgery
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge
timeFrame: 6 weeks
Other outcomes:
Locations:
city: LaJolla
country: United States
state: California
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Chapel Hill
country: United States
state: North Carolina
city: Hershey
country: United States
state: Pennsylvania
city: Pittsburg
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Perth
country: Australia
city: Vienna
country: Austria
city: Budapest
country: Hungary
city: Auckland
country: New Zealand
city: Chirstchurch
country: New Zealand
city: Warsawa
country: Poland
city: Bucurest
country: Romania
city: Malmö
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: