louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06593327: NT-ProBNP-based Heart Failure Screening and Prevention Trial in Patients with Type 2 Diabetes: STRONG-DM Study
Official title: Evaluation of a Pragmatic NT-ProBNP-based Heart Failure Screening Strategy Among Patients with Type 2 Diabetes: STRONG-DM Study (Screening and Treatment Using Risk-based ApprOach with NT-ProBNP Guidance in Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Diabetic Cardiomyopathy
Heart Failure
Cardiometabolic Diseases
Keywords: Pragmatic Clinical Trial
Heart Failure
Cardiovascular Prevention
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2024-09-19
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A pragmatic, randomized clinical trial to evaluate the effect of a heart failure (HF) risk assessment and prevention strategy incorporating HF clinical risk scores (WATCH-DM) with cardiac biomarker (NT-proBNP) paired with a clinical decision support tool to implement an intensive prevention strategy among patients with high risk focused on implementation of evidence-based HF preventive therapies.

Detailed description: Primary care providers will be randomized to receive notifications via the electronic health record if any patients with diabetes have high heart failure risk based on a combination of clinical risk scores(WATCH-DM), and biomarkers (NT-proBNP). Providers will be provided recommendation to initiate evidence based therapies (SGLT2 inhibitors, GLP1 agonists, non-steroidal MRA) , obtain expert e-consultation, or refer the patient to a cardiometabolic risk management program.

Eligibility criteria: Inclusion Criteria:

* Primary Care Provider that sees diabetes patients in clinic

Exclusion Criteria:

* Provider does not see patients with Diabetes

Primary outcomes:
measure: Incident Heart Failure or All-cause death
timeFrame: 2-year follow-up
Secondary outcomes:
measure: Prescription Rates of SGLT2i
timeFrame: 6-months from electronic health record alert.
measure: Prescription Rate of Finerenone
timeFrame: 6-months from electronic health record alert.
measure: Prescription Rate of GLP1
timeFrame: 6-months from electronic health record alert.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT00899327: Biomarkers in Patients at Risk of Developing Myelodysplastic Syndrome or Other Disorders and in Healthy Participants
Official title: Molecular and Functional Characterisation of Bone Marrow Function in Normal Subjects, Myelodysplastic Syndromes (MDS) and Secondary Disorders of Heamatopoiesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia
Myelodysplastic Syndromes
Keywords: myelodysplastic syndromes
acute myeloid leukemia
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients at risk of developing myelodysplastic syndrome may help doctors learn more about changes that occur in DNA and identify biomarkers related to disorders of the blood and bone marrow.

PURPOSE: This research study is looking at biomarkers in patients at risk of developing myelodysplastic syndrome or other disorders and in healthy participants.

Detailed description: OBJECTIVES:

Primary

* To identify novel biomarkers of disease that would help in the initial diagnosis of myelodysplastic syndromes (MDS).

Secondary

* To understand the genesis of anemia in cancers.
* To identify novel biomarkers of disease that predict progression of MDS to acute myeloid leukemia.

OUTLINE: Blood and bone marrow samples are collected. Hemopoietic stem cells (HSC) and progenitor cells are isolated from samples for analysis. Some of these HSC and progenitor cells are used for functional assays. From the rest of the cells, DNA, RNA, and protein is extracted for molecular analyses, including gene mutation analysis, gene methylation assays, chromatin immunoprecipitation, microarray, and real-time polymerase chain reaction.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Must meet 1 of the following criteria:

  * Being investigated for a potential blood disorder due to abnormal blood count
  * Patients with a known blood disorder who are having a bone marrow sample taken as part of the assessment of that disorder
  * Patients undergoing hip replacement surgery at Nuffield Orthopaedic Centre, Oxford meeting the following criteria:

    * Not on treatment likely to impair bone marrow function
    * No history of having had treatment likely to have impaired bone marrow function
    * Normal blood count
  * Archived samples from patients with known blood disorder

PATIENT CHARACTERISTICS:

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Identification of novel biomarkers of disease
Secondary outcomes:
measure: Identification of novel biomarkers of disease progression from myelodysplastic syndromes to acute myeloid leukemia
measure: Comprehension of genesis of anemia in cancer
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospital
state: England
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Vyas Paresh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02853227: The Telemark Score: a Reliable Method for Evaluation of Results After Breast Surgery
Official title: The Telemark Breast Score is a Valid Method for the Evaluation of Outcome After Reconstructive Surgery of the Breast
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Telemark score, reliability
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
First posted: 2016-08-02
Enrollment: 376
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2 cohorts, one subjected to BCS and one to DIEP surgery.

Brief summary: This paper will present a specific tool for evaluation of cosmetic results after breast conserving surgery (BCS) and secondary breast reconstruction with free DIEP-flap. Introduction of a breast score system using digital photography seems to be a reliable tool for estimation of cosmetic results after breast surgery. The method has been employed on a specific group of 346 consecutive patients operated for breast cancer with breast conserving surgery. For the purpose of this study breast score system was tested on patients with free flap breast reconstruction (DIEP flap).

Detailed description: Background: Validated instruments for assessing results after breast surgery are sparse. Investigators want to present a method used for the past 10 years at their institution for evaluation of the outcome after breast conserving surgery (BCS) and microsurgical breast reconstruction. Methods: 346 consecutive patients subjected to BCS for cancer and 30 patients operated with a deep inferior epigastric flap (DIEP ) were assessed at least one year after the operation. The Telemark Breast Score is a method based on standard two-dimensional photographs assessing the outcome after breast surgery in terms of volume, shape and symmetry. Three different panels including plastic surgeons, breast surgeons and nurses were invited to test the Telemark Breast Score. Consistency of agreement between and inside the panel groups was studied Results: Inter- and intra observer reliability was acceptable. Good stability of ratings could be shown in test-retests.

Conclusion: The Telemark Breast Scale is inexpensive, statistically reliable and can be applied for quality control after breast surgery.

Eligibility criteria: Inclusion Criteria:

* Patients operated for breast cancer at Hospital of Telemark

Exclusion Criteria:

* Patients operated for breast cancer and not subjected for irradiation

Primary outcomes:
measure: Telemark Breast Score
timeFrame: 2013-2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03635827: Xenon Inhalation for Treatment of Posttraumatic Stress Disorder
Official title: A Double-Blind, Randomized, Placebo-Controlled Trial of Xenon Inhalation for Treatment of Patients With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Nobilis Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-17
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with PTSD.


Eligibility criteria: Inclusion Criteria:

* Patients with a current diagnosis of PTSD (documented diagnosis of PTSD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition \[DSM-5\] criteria and a Clinician Administered PTSD Scale \[CAPS-5\] total severity score of \>30).
* Male and female patients between the ages of 18 and 85 years.

Exclusion Criteria:

* History of schizophrenia, bipolar and other psychotic disorders.
* Patients with underlying pulmonary disease, chronic obstructive pulmonary disease (COPD), asthma or any other respiratory conditions / diseases that may affect the respiratory function.
* Currently undergoing PTSD-targeted psychotherapy.
* Currently undergoing exposure-based psychotherapy for any condition.

Primary outcomes:
measure: CAPS-5
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: PCL-5
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03212027: Preoperative Prediction of of Thymic Epithelial Tumors by Diffusion-Weighted MR Imaging
Official title: Preoperative Prediction of the Pathological Classification of Thymic Epithelial Tumors by Apparent Diffusion Coefficient Using Ultra-high B-values
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thymic Epithelial Tumor
Keywords: apparent diffusion coefficient
aquaporins
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with thymic epithelial tumors

Brief summary: The aim of this study is to analyze aquaporins expression of thymic epithelial tumors and to compare them with apparent diffusion coefficient(ADC) from ultra-high b-values, and to test a possibility of use of ADCuh to identify the pathological type of tumor.

Detailed description: Magnetic resonance (MR) diffusion-weighted imaging (DWI) measures water diffusion in biological tissue. The quantification of diffusion is described by the apparent diffusion coefficient (ADC),which largely depends on the number and separation of barriers.Thus, ADC can provide information regarding tissue microstructure.

According to the literature, ADC is also related to cell membrane permeability for water molecules.It is well known that cellular water transport depends on aquaporins (AQPs).In general,the expression of aquaporins might differ in several pathologic disorders. With reference to this fact,we hypothesize that AQPs expression may influence ADC in thymic epithelial tumors(TETs).Therefore,the aim of the present study is to analyze possible associations between ADC from ultra-high b-values and AQPs expression(ADCuh) in TETs and to use ADCuh to identify the pathological type of tumor.

Eligibility criteria: Inclusion Criteria:

* no use of corticosteroid drugs;
* no MRI contraindication;
* no infection or fever;
* tumor diameter is greater than 2cm.

Exclusion Criteria:

-

Primary outcomes:
measure: Different DWI parameters in thymic epithelial tumors
timeFrame: 6 months
Secondary outcomes:
measure: To acquire aquaporins expression level of thymic epithelial tumors
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03852927: Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma
Official title: Computer Guided Contouring of Craniofacial Fibrous Dysplasia Involving Zygoma: a Case Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Craniofacial Fibrous Dysplasia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 5
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will be conducted on patients with monostotic unilateral craniofacial fibrous dysplasia affecting zone I (fronto-orbital, zygomatic, and upper maxillary regions). Computer guided shaving will be performed for all the patients, and the accuracy of this procedure will be assessed.

Detailed description: This study will be conducted on patients with monostotic unilateral craniofacial fibrous dysplasia affecting zone I (fronto-orbital, zygomatic, and upper maxillary regions).

I. Preoperative preparation

1. Virtual planning Computed tomography (CT) will be performed for the skull using a multi-slice helical CT machine. Computed tomography DICOM (digital Imaging and Communication in Medicine) files will be imported to the 3D surgical planning software (Mimics 10.0, Materialise NV, Leuven, Belgium). Using the software and through a series of segmentation and simulation processes, area of interest will be virtually selected and separated. Finally, the virtual image of the surgical guide will be reconstructed.
2. Rapid prototyping Stereolithographic (STL) files of the virtual image will be exported to multi-jet modelling printing machine (InVision Si2, 3D Systems e Rock Hill, SC) and will be fabricated using plastic material (VisiJet SR 200, 3D Systems e Rock Hill, SC).

II. Surgical procedures Area of interest for all patients will be exposed using the hemicoronal, and maxillary intraoral vestibular incisions. The surgical guide(s) will be seated in position on the affected side. Bone removal will be performed through the guide according to the preoperative planning. The bone removal will be then performed to connect the guiding holes using surgical burs. Finally, the incisions will be sutured after soft tissue suspension.

III. Follow up Postoperative CT will be performed for postoperative assessment. After 1 week patients will be recalled for suture removal and clinical assessment. Then the patients will be recalled 1, 3 months for further assessment.

Eligibility criteria: Inclusion Criteria:

* Monostotic unilateral craniofacial fibrous dysplasia.
* Facial asymmetry affecting zone I (fronto-orbital, zygomatic, and upper maxillary regions)
* More than 17 years

Exclusion Criteria:

* functional deficits
* orbital manifestations

Primary outcomes:
measure: Accuracy
timeFrame: 1 week after the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Cairo university
Study officials:
References:
Clinical trial NCT05912127: All on Four Versus All on Three Implant Treatment Concepts
Official title: All On-4 Versus All o-3 Implant Treatment Concepts for Rehabilitation of Atrophied Mandibular Ridge. A Study of Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis Durability
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be classified into 2 groups according to the implant treatment concept they received:

* Group 1 (control group); included 3 patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.
* Group 2 (test group); included 3 patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.
Primary purpose: TREATMENT

Brief summary: the evaluation of patient satisfaction of All on-4 versus All on-3 implant treatment concepts rehabilitation of atrophied mandibular ridge.

Detailed description: Patients will be classified into 2 groups according to the implant treatment concept they received:

* Group 1 (control group); included patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.
* Group 2 (test group); included patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.

Eligibility criteria: Inclusion Criteria:

* 1. All patients already have implants inserted in their mandibular ridges According to the All on 4 or All on 3 concepts.

  2. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetes or osteoporosis. This was achieved through medical history and clinical examination by the physician.

  3. All patients have sufficient inter-arch space. 4. All patients are of angle class I maxillo-mandibular relationships. 5. All patients had maxillary conventional complete dentures.

Exclusion Criteria:

1. Any neuromuscular disorders 2. Uncooperative patients

-

Primary outcomes:
measure: patient satisfaction
timeFrame: one year
measure: crestal bone loss
timeFrame: Two year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Christine Ibrahim
Study officials:
affiliation: professor of prosthodontics, Faculty of dentistry , Mansoura University
name: Mostafa Elsyad, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02201927: Stimulation Galvanique Vestibulaire
Official title: Galvanic Vestibular Stimulation : Role in the Improvement of Egocentric Frame in Patient With Right Parietal Lobe Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertensive Hemorrhage of Right Parietal Lobe
Keywords: galvanic vestibular stimulation
right parietal lobe lesion
egocentric space
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: University of Versailles
First posted: 2014-07-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Right posterior parietal cortex is involved in spatial cognition. Blindfolded patients suffering right posterior parietal lesions fail to update their own position after a body rotation. Right cathodal galvanic vestibular stimulation activates right posterior parietal cortex and reduces symptoms of spatial neglect, another disability frequently encountered after right posterior parietal lesion. The aims of this study are to confirm posterior parietal involvement in automatic updating of body-centered spatial relationships and to evaluate therapeutic effects of galvanic vestibular stimulation. Performances of three groups of adults are compared before and during galvanic vestibular stimulation on a pointing task: a healthy control group, a brain-injured control group with stroke lesions sparing right posterior parietal cortex and a group of stroke patients with right posterior parietal lesions.


Eligibility criteria: Inclusion Criteria:

* patient with right posterieur parietal lobe lesion
* patient with cerebral vascular stroke
* healthy volonteers Age greater than or equal to 18 written informed consent

Exclusion Criteria:

* patient's refusal to participate to the study
* inability to cooperate
* cognitive trouble
* epilepsy

Primary outcomes:
measure: deviation from target score
timeFrame: 30 min
Secondary outcomes:
measure: deviation from target "straight ahead"
timeFrame: 30min
measure: deviation rightward line bisection
timeFrame: 30min
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare Mpr
Study officials:
affiliation: HOPITAL RAYMOND POINCARE
name: Ruet Alexis, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04084327: Immunophenotyping of Acute b Cell Lymphoblstic Leukemia
Official title: Immunophenotyping of Acute b Cell Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Leukemia
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: new cases Who didn't receive treatment.Age above 1 years old.

Brief summary: To study the immunophenotyping pattern of acute B lymphoblastic leukemia in south Egypt Cancer Institute iand its correlation with disease outcome

Detailed description: study the immunophenotyping pattern of acute B lymphoblastic leukemia in south Egypt Cancer Institute from 2009 -2019 and its correlation with disease outcome

Eligibility criteria: Inclusion Criteria:

* New cases admitted to SECI Who didn't receive treatment.Age above 1 years old.

Exclusion Criteria:

* Cases who received treatment Patients below 1 years old.Patients diagnosed as AML or T-ALL

Primary outcomes:
measure: overall survival outcome
timeFrame: 10 years
measure: Disease-free survival outcome
timeFrame: 10 years
measure: association of novel CD markers with old markers for assessment of disease outcome
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Keegan A, Charest K, Schmidt R, Briggs D, Deangelo DJ, Li B, Morgan EA, Pozdnyakova O. Flow cytometric minimal residual disease assessment of peripheral blood in acute lymphoblastic leukaemia patients has potential for early detection of relapsed extramedullary disease. J Clin Pathol. 2018 Jul;71(7):653-658. doi: 10.1136/jclinpath-2017-204828. Epub 2018 Mar 27.