louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05557994: Assessment of Different Disinfection Protocols on Regenerative Potential of Mature Teeth
Official title: Assessment of Different Disinfection Protocols on Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apical Periodontitis
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. The aim of this study is to assess the regenerative potential of mature permanent teethwith necrotic pulps after disinfecting the root canal using diode laser andcompare it with dynamic agitation of xp-endo finisher and conventionaltriple antibiotic paste


Eligibility criteria: Inclusion Criteria:

Patients with mature teeth. Patients with periapical periodontitis. Maxillary anterior teeth only will be involved. Patients should be free from any systemic disease that may affect normal healing and predictable outcome.

Patients who will agree to the consent and will commit to follow up period.

Exclusion Criteria:

* Patients with immature roots. - Immuno-compromised patients, including patients who self-reportedto be a carrier of HIV, hepatitis, undergoing steroid therapy, thosewho self-reported with genetic or systemic diseases that could resultin a reduced immune response.- All patients who respond positive to allergic patch test \[tripleantibiotic paste\] and drugs.- Pregnant and lactating women.- Patients who could/would not participate in a 1-year follow-up.- Teeth with previous endodontic therapy performed. - Teeth with periodontal involvement. - Teeth with calcified canals.- Presence of external or internal root resorption.- Teeth with root fractures (checked with pre-operative radiographsusing horizontal and vertical angulations)

Primary outcomes:
measure: Clinical success
timeFrame: 9 months
Secondary outcomes:
measure: Radiographic success
timeFrame: 9 months
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Abanoub Raouf
state: Bani Suwayf
Study officials:
References:
Clinical trial NCT03609294: A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Linagliptin in Healthy Volunteers
Official title: A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg and Co-administration of Fimasartan 120 mg and Linagliptin 5 mg in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Diabetes
Keywords: Fimasartan
Linagliptin
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-01
Enrollment: 67
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated Fimasartan and Linagliptin.

Detailed description: This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Linagliptin and co-administration of Fimasartan and Linagliptin.

Eligibility criteria: Inclusion Criteria:

1. Male 19-50 years of age.
2. Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
3. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
4. Medically healthy with no clinically significant medical history.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease.
2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
3. Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg at screening.
4. Plasma donation within a month prior to the first dose of study drug.
5. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).

Primary outcomes:
measure: Cmax
timeFrame: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration
measure: AUClast
timeFrame: Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Dahak-ro
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03835494: Analysis of RV-Dysfunction in Fallot Patients
Official title: Tissue Doppler Imaging - A Promising Technique To Assess Myocardial Function In Adult Fallot Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tetralogy of Fallot
Keywords: Tetralogy of Fallot
Tissue Doppler Imaging
Exercise testing
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Transthoracic echocardiography including TDI is performed at rest, during PLR, HG and CPX in Fallot patients and healthy controls. In Fallot patients, transthoracic ultrasound at rest and during CPX are part of the routinely follow-up. PLR and HG were performed additionally as part of the investigator's study to analyze TDI parameters during various endurance testings
Primary purpose: OTHER

Brief summary: In the presented study TDI will be used as a modern technique to characterize RV-function in Fallot patients at rest and during different exercise conditions.

Detailed description: Tissue Doppler imaging (TDI) presents a modern technique to depict the velocity of tissue motion within a distinct area of the myocardium providing amendatory characterization of diastolic and systolic function of the heart. TDI is hypothesized to be of additional value in the evaluation of adult congenital heart disease, especially tetralogy of Fallot (TOF), which is one of the most common conditions. In particular, Fallot patients are at risk of developing right ventricular (RV) dysfunction due to pulmonary valve defects or alterations of the outflow tract. It is pivotal to recognize this progression at an early stage before irreversible changes occur. Aim of the study is to test feasibility of TDI in Fallot patients as a new technique that provides new parameters to characterize RV dysfunction, more precise than common methods. Additionally TDI is performed at rest and during different endurance testings (passive Leg Raising (PLR), handgrip (HG) and cardiopulmonary exercise (CPX), as certain changes might be compensated at rest, first apparent during exercise.

Eligibility criteria: Inclusion Criteria:

* Patients with corrected tetralogy of Fallot
* Adult healthy controls without cardiovascular disease or other relevant systemic diseases with written consent

Exclusion Criteria:

* Inability to give written consent, incapable of cycling or handgrip exercise due to cognitive or orthopedic limitation, poor echocardiographic image quality

Primary outcomes:
measure: Right ventricular myocardial velocity
timeFrame: Baseline
Secondary outcomes:
measure: Peak oxygen consumption (ml/min/kg) and Oxygen consumption at anaerobic threshold (ml/min/kg)
timeFrame: Baseline
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
References:
Clinical trial NCT02981394: Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions
Official title: Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Musculoskeletal Pain
Osteoarthritis
Tendinopathy
Sprains Strain
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a musculoskeletal condition amenable to BMAC or PRP treatment will be enrolled upon registration for the selected procedure. Proper counseling regarding the selected procedure and alternatives will be done prior to enrollment. Patients with contraindications for the procedure will not undergo the procedure and therefore will not be enrolled. The study will be non-randomized; therefore, patient selection will be based upon patient request for the procedure after proper counseling. Counseling regarding cost of each procedure will also be provided. All costs for the procedure will be the responsibility of the patient. Proper documentation will also be signed by the patient indicating that procedure is elective and PRP/BMAC injections will not be billed to their insurance carriers. Upon enrollment, patients will be consented for the procedure and longitudinal data collection.

Brief summary: The use of Bone Marrow Autologous Collection (BMAC) in musculoskeletal conditions including osteoarthritis and tendon injuries has been growing. Outcome evidence continues to be sparse. The purpose of this study is collect a longitudinal case series of patient reported outcomes following BMAC injections for musculoskeletal conditions including osteoarthritis, tendinopathy and injuries to ligaments, tendons and muscles.


Eligibility criteria: Inclusion Criteria:

* Musculoskeletal Condition that is able to undergo an injection
* Patient requests the procedure and enrolls with agreement to pay for the procedure

Exclusion Criteria:

* Active Cancer
* Allergies to local anesthesia

Primary outcomes:
measure: WOMAC Score
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Midwest Orthopeadics at Rush
state: Illinois
Study officials:
References:
Clinical trial NCT01063894: Effects of Breakfast on Cognitive Processes in Children
Official title: A Randomized, Controlled, Parallel Trial to Evaluate the Effects of Breakfast on Cognitive Processes in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Lead sponsor: Kellogg Company
Sponsor class: INDUSTRY
Collaborators: name: Provident Clinical Research
First posted: 2010-02-05
Enrollment: 291
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to test the effects of breakfast on cognitive processing ability in children.

Detailed description: Breakfast consumption has previously been shown to positively affect cognitive and academic performance in children. Specifically, breakfast consumption has been reported to improve memory, attention, problem solving, and logical reasoning compared to the absence of breakfast. This has been found under both short-term laboratory conditions and within a school environment in children from both a low and high socioeconomic background, although some studies have failed to find favorable effects.

Eligibility criteria: Inclusion Criteria:

* Subject is willing to maintain their habitual diet and physical activity patterns throughout the study period
* Provision of assent by subject
* Subject's guardian provides informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators

Exclusion Criteria:

* Diagnosis of attention deficit disorder, with or without hyperactivity
* A diagnosis of diabetes mellitus
* Acute illness or use of antibiotics within 5 days of visit
* Subject is a non-breakfast eater defined as not regularly eating food prior to 1000 h
* Known sensitivity or allergy to any ingredients of the study product
* Use of any psychotropic medication within 4 weeks
* Subject did not previously participate in an earlier trial with the same study products
* Exposure to investigational agent within 30 days.
* Individual has a condition the Investigator believes would interfere with his or her ability to provide assent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk

Primary outcomes:
measure: Quality of Memory and Attention based on results using CDR System
timeFrame: 4 hours following breakfast
Secondary outcomes:
measure: Speed of Memory and Attention based on results using CDR System
timeFrame: 4 hours following breakfast
Other outcomes:
Locations:
city: Addison
country: United States
facility: Provident Clinical Research
state: Illinois
Study officials:
affiliation: Provident Clinical Research
name: Kevin Maki, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06358794: Machine Learning Based-Personalized Prediction of Sperm Retrieval Success Rate
Official title: SpermFinder: Machine Learning Based-Personalized Prediction of Sperm Retrieval in Patients With Nonobstructive Azoospermia Prior to Microdissection Testicular Sperm Extraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Male
Azoospermia, Nonobstructive
Keywords: Machine learning
Predictive model
Sperm retrieval
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 2612
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nonobstructive azoospermia patients who underwent microdissection testicular sperm extraction at the Reproductive Center of Peking University Third Hospital were respectively enrolled.

Brief summary: Non-obstructive azoospermia (NOA) stands as the most severe form of male infertility. However, due to the diverse nature of testis focal spermatogenesis in NOA patients, accurately assessing the sperm retrieval rate (SRR) becomes challenging. The current study aims to develop and validate a noninvasive evaluation system based on machine learning, which can effectively estimate the SRR for NOA patients. In single-center investigation, NOA patients who underwent microdissection testicular sperm extraction (micro-TESE) were enrolled: (1) 2,438 patients from January 2016 to December 2022, and (2) 174 patients from January 2023 to May 2023 (as an additional validation cohort). The clinical features of participants were used to train, test and validate the machine learning models. Various evaluation metrics including area under the ROC (AUC), accuracy, etc. were used to evaluate the predictive performance of 8 machine learning models.


Eligibility criteria: Inclusion Criteria:

* diagnosed with nonobstructive azoospermia
* underwent microdissection testicular sperm extraction

Exclusion Criteria:

* without intact clinical information
* low data quality

Primary outcomes:
measure: SRR of micro-TESE
timeFrame: At the time after microdissection testicular sperm extraction
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06716294: Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET Confirmation
Official title: Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET Confirmation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Cancer Metastatic
Radiofrequency Ablation
Spine Metastases
Vertebral Metastasis
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Sixteen (16) patients will be enorolled.
* - only patients with secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled.
* lesions to be treated must be metabolically active on PET-CT performed during the last month.
* Patients will be informed and sould sign an inform consent.
* post treatment patients should submittes a new PET-CT in order to verify the activity of the treated area.

Brief summary: This pilot study will try to demonstrate metabolic changes in spine lesions treated by Augmentation and Ablation, according to existing standards of practice. Our purpose is to show the efficacy of a new radiofrequency radioablation (RFA) in combination with augmentation, using a percutaneous ablation device (Osteocool-Medtronic) in the treatment of secondary vertebral bone tumor, avoiding concurrent bias related to other treatments of the disease.

Detailed description: Only patient supposed to undergo percutaneous vertebral augmentation for secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled. Lesions to be treated must be metabolically active on PET-CT, performed during the last month. Patients will be informed and sign and inform consent. Patients will be treated with Augmentation and Ablation (Osteocool-Medtronic). Post treatment patients will be submitted to a new PET-CT in order to verify activity on treated site.

Eligibility criteria: Inclusion Criteria:

* only patients with secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled.
* lesions to be treated must be metabolically active on PET-CT performed during the last month.
* Patients will be informed and sould sign an inform consent.
* post treatment patients should submittes a new PET-CT in order to verify the activity of the treated area.

Exclusion Criteria:

-

Primary outcomes:
measure: PET
timeFrame: SUV measurement of PET in 24 hours
Secondary outcomes:
measure: GBPI
timeFrame: 1 MONTH, 6 MONTHS, 12 MONTHS
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Attikon General University Hospital
state: Haidari
Study officials:
affiliation: National and Kapodistrian University of Athens, Greece
name: ALEXIOS KELEKIS, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05821894: Carotid Plaque Imaging Project (CPIP)
Official title: Carotid Plaque Imaging Project (Identification of Vulnerable Atherosclerotic Plaques With Imaging and Biological Markers)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atherosclerosis
Atherosclerotic Plaque
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Region Skåne
name: The Swedish Research Council
name: Swedish Heart Lung Foundation
name: Skåne University Hospital funds (incl. the Medical Training and Research Agreement/ALF)
name: Swedish Foundation for Strategic Research
First posted: 2023-04-20
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with carotid stenosis undergoing endarterectomy at Skåne University Hospital (SUS), Malmö, Sweden.

Brief summary: The rupture or erosion of an atherosclerotic plaque with thrombosis or embolization often underlie heart attacks and strokes. The early identification of patients with atherosclerotic plaques prone to rupture or erosions, vulnerable plaques (VP), and their treatment before the occurrence of events is, therefore, one of the greatest cardiovascular challenges today. Possible approaches for early detection of VP include imaging techniques allowing visualization of plaque structure, circulating biomarkers and better understanding of the pathophysiologic mechanisms of the disease. In the carotid plaque imaging project the investigators study human atherosclerotic plaques (that are removed by endarterectomy) to disclose their underlying structure and mechanisms, finding possible novel therapeutic targets or markers for VP. The investigators also study plaque structure with imaging methods and try to develop new ways to detect VP using circulating or imaging markers.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old, male or female that are eligible for carotid endarterectomy due to atherosclerosis and that can provide informed consent.

Exclusion Criteria:

* Patients younger than 18 years old that cannot provide informed consent; pregnant.

Primary outcomes:
measure: Number of participants suffering post-operative cardiovascular events (by 2025)
timeFrame: Follow up assessment year 2025 (recording of events occurring since 2023)
measure: Number of participants suffering post-operative cardiovascular events (by 2027)
timeFrame: Follow up assessment year 2027 (recording of events occurring since 2025)
measure: Number of participants suffering post-operative cardiovascular events (by 2029)
timeFrame: Follow up assessment year 2029 (recording of events occurring since 2027)
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital (SUS)
state: Skåne
Study officials:
affiliation: Lund University
name: Isabel Goncalves, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: