louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04977778: Effectiveness in Dental Plaque Reduction of Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride
Official title: Effectiveness in Dental Plaque Reduction of Two Mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride: a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Gingival Diseases
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparative study on the efficacy of two mouthwashes Containing Fatty Acids Compounds (F.A.G.) or Stannous Fluoride in the reduction of plaque score in individuals with spontaneous gengivitis


Eligibility criteria: Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Smoking
* Drugs prior month
* Dental hygiene \<6 months
* Pregnancy

Primary outcomes:
measure: Change in plaque score
timeFrame: Baseline; 2 weeks
Secondary outcomes:
measure: Bleeding on Probing
timeFrame: Baseline; 2 weeks
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: University of L'Aquila
state: IT
Study officials:
References:
Clinical trial NCT06527378: Artificial Intelligence in Dental Implant Planning
Official title: The Role and Applications of Artificial Intelligence in Dental Implant Planning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edentulous Alveolar Ridge
Edentulous Mouth
Tooth Loss
Keywords: Artificial Intelligence in Implantology
AI in Dental Implantology
Machine Learning in Dental Implantology
Deep Learning in Implant Dentistry
Robotics in Dental Implantology
AI-Based Implant Planning
Lead sponsor: University of Bari Aldo Moro
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with edentulous ridges who need fixed prosthetic rehabilitation

Brief summary: Artificial intelligence (AI) is revolutionizing the dentistry, offering new opportunities to improve the precision and efficiency of implantology. This study aims to evaluate the current evidence on the use of AI in implant planning assessment

Detailed description: The analysis was conducted through electronic search engines, using a combination of relevant keywords, including "artificial intelligence implantology," "AI implant planning," "AI dental implant," and "implantology artificial intelligence." Selected articles will carefully re-viewed to identify studies reporting data on the effectiveness of AI in implant planning.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent 3D or 2D radiological examinations for implant-prosthetic rehabilitation

Primary outcomes:
measure: Valuation on the diagnosis of anatomical structures
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Mola di Bari
country: Italy
facility: Giuseppe D'Albis
state: Bari
Study officials:
References:
citation: Macri M, D'Albis V, D'Albis G, Forte M, Capodiferro S, Favia G, Alrashadah AO, Garcia VD, Festa F. The Role and Applications of Artificial Intelligence in Dental Implant Planning: A Systematic Review. Bioengineering (Basel). 2024 Jul 31;11(8):778. doi: 10.3390/bioengineering11080778.
Clinical trial NCT04344678: The Phosphodiesterase 5 Inhibitor Sildenafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients
Official title: The Phosphodiesterase 5 Inhibitor Sildenafil as an Adjunct to Antidepressants in Major Depressive Disorder Patients: Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2020-04-14
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: TREATMENT

Brief summary: Antidepressant-like effects of sildenafil to its ability to modulate transduction pathways responsible for neuroplasticity. Treatment with sildenafil was shown to be PKG-dependent and lead to increased expression of cGMP, pCREB, BDNF and VGF in the hippocampus and prefrontal cortex (PFC), brain areas relevant to mood disorders pathophysiology. Sildenafil produces antidepressant-like effects by inhibiting oxidative stress in the hippocampus and by decreasing the levels of IL-1β in the hippocampus and striatum.


Eligibility criteria: Inclusion Criteria:

* Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
* Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.

Exclusion Criteria:

* Patients with bipolar I or bipolar II disorder
* Patients with personality disorders
* Patients with eating disorders
* Patients with substance dependence or abuse
* Patients with concurrent active medical condition
* Patients with history of seizures
* Patients with history of receiving Electroconvulsive therapy (ECT)
* Patients with inflammatory disorders
* Patients with allergy or contraindications to the used medications
* Patients with finally pregnant or lactating females
* Cardiovascular disorders
* Severe renal impairment: creatinine clearance of ≤ 25 ml/min
* Moderate or severe hepatic impairment

Primary outcomes:
measure: Effect on Hamilton Depression rating scale score (HAM-D score)
timeFrame: 12 week
Secondary outcomes:
measure: Effect on biological markers
timeFrame: 12 week
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT04763278: Validation of User Needs of the Point Digit With Partial Hand Amputees
Official title: Validation of User Needs of the Point Digit With Partial Hand Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation; Traumatic, Hand
Lead sponsor: Point Designs
Sponsor class: INDUSTRY
Collaborators: name: University of Colorado, Denver
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-02-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of the device feasibility study will be to validate the user needs of the Point Digit system. This study will be a single group intervention model where one group of 5 partial hand amputees will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.


Eligibility criteria: Inclusion Criteria:

* Partial hand amputees with absence of index and/or middle fingers and presence of thumb. Additional finger loss is acceptable if all other criterion are met.
* Fluent in English
* Individuals aged 18 or greater

Exclusion Criteria:

* Significant cognitive deficits as determined upon clinical evaluation
* Significant neurological deficits as determined upon clinical evaluation
* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
* Uncontrolled pain or phantom pain impacting full participation in the study as determined upon occupational therapist evaluation
* Serious uncontrolled medical problems as judged by the project therapist.

Primary outcomes:
measure: VAL-1: System Comfort Validation Test
timeFrame: Day 1 (8 hours)
measure: VAL-2: Unilateral Function Validation Test
timeFrame: Day 1 (10 minutes)
measure: VAL-3.1: System Robustness Validation Test With 25 lb Bag
timeFrame: Day 1 (10 minutes)
measure: VAL-3.2: Robustness Validation Test With Hammer
timeFrame: Day 1 (10 minutes)
measure: VAL-4: Object Release Validation Test
timeFrame: Day 1 (10 minutes)
measure: VAL-5: Position Function Validation Test
timeFrame: Day 1 (10 minutes)
measure: VAL-6: Extension Function Validation Test
timeFrame: Day 1 (10 minutes)
measure: VAL-7: Grip Functions Validation Test
timeFrame: Day 1 (10 minutes)
measure: VAL-8: Fine Motor Function Validation Test
timeFrame: Day 1 (10 minutes)
measure: VAL-9: Overall Function & Robustness Validation Test
timeFrame: Day 1 (8 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver | Anschutz Medical Campus
state: Colorado
city: Lafayette
country: United States
facility: Point Designs
state: Colorado
Study officials:
References:
Clinical trial NCT02481778: Monitoring Radiation Induced Cardiac Damage by Blood Markers
Official title: Monitoring Radiation Induced Cardiac Damage by Blood Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Induced Cardiac Damage
Keywords: Radiotherapy
Cardiac
Toxicity
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 96
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: Patients with esophageal- or non small cell lung cancer treated with radiotherapy with curative intention, with or without chemotherapy, with or without surgery, at the department of radiotherapy at the University Medical Centre Groningen

Brief summary: Rationale:

Radiation induced cardiac toxicity after treatment for intrathoracic tumours is a clinically relevant problem. So far, no clinical prediction models exist for cardiac toxicity. In particular, the relationship between radiation dose parameters and the risk of cardiac toxicity remains to be determined.

Clinical prediction models for cardiac toxicity are difficult to obtain, e.g. due to long latency time. Therefore, objective surrogate markers, for cardiac toxicity such as NT pro BNP and hs-TNT, as obtained during and after treatment may be of great value.

Objective:

The main objective to find a correlation between the rise in NT pro BNP level and the radiation dose given to the heart.


Eligibility criteria: Inclusion Criteria:

* Histologically proven oesophageal- or lung cancer (adeno-, or squamous cell carcinoma or other NSCLC type)
* Older than 18 years
* Written informed consent

Exclusion Criteria:

* Prior radiotherapy to the chest including radiotherapy for breast cancer
* Patients treated with palliative intent

Primary outcomes:
measure: Change in percentage of rise of the level of NT pro BNP after radiotherapy
timeFrame: At 1 year after end of radiation therapy
Secondary outcomes:
measure: Cardiac events
timeFrame: After start treatment up to 2 years after end of radiation therapy.
measure: Change in percentage of rise of hs-TNT during or after treatment
timeFrame: At day 1 start radiation therapy and at last day of radiation therapy (an expected average of 5 weeks after start of radiation therapy) and at 4 weeks, 6 months, 1 and 2 years after end of radiation therapy.
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT05587478: A Study of EDP-323 in Healthy Subjects
Official title: A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In- Human Study of Orally Administered EDP-323 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-323 Pharmacokinetics in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: RSV Infection
Keywords: First-in-Human
Single Ascending Dose
Multiple Ascending Dose
Healthy Volunteer
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2022-10-20
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-323 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day -1 visit
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.

Primary outcomes:
measure: Safety measured by adverse events
timeFrame: Up to 8 Days in SAD Cohorts
measure: Safety measured by adverse events
timeFrame: Up to 14 Days in MAD Cohorts
Secondary outcomes:
measure: Cmax of EDP-323
timeFrame: Up to 5 Days in SAD Cohorts
measure: AUC of EDP-323
timeFrame: Up to 5 Days in SAD Cohorts
measure: Cmax of EDP-323
timeFrame: Up to 11 Days in MAD Cohorts
measure: AUC of EDP-323
timeFrame: Up to 11 Days in MAD Cohorts
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON, plc.
state: Kansas
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References:
Clinical trial NCT06646978: Long-term Risk of Second Primary Malignancies for Chronic Myeloid Leukaemia in the French Imatinib-based SPIRIT Trial
Official title: Long-term Risk of Second Primary Malignancies for Chronic Myeloid Leukaemia in the French Imatinib-based SPIRIT Trial
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Myeloid Leukemia (CML)
Keywords: second primary malignancies
imatinib
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 787
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: All patients with chronic myeloid leukaemia included in the French imatinib-based SPIRIT trial

Brief summary: Imatinib is a tyrosine kinase inhibitor that has improved the prognosis of patients with chronic myeloid leukemia (CML). CML has become a chronic disease requiring long-term administration of imatinib. Late adverse effects were initially unknown. Since 2005, imatinib has been suspected to increase the risk of second primary malignancies (SPM). Through the French "STI571 Prospective Randomized Trial" (SPIRIT), we studied the incidence of SPM after more than 20 years of exposure, and treatment strategies for CML and SPM at their occurrence.


Eligibility criteria: Inclusion Criteria:

* Included in the French SPIRIT trial

Exclusion Criteria:

* None

Primary outcomes:
measure: Risk of second primary malignancies (SPM)
timeFrame: Through study completion, an average of 20 years
Secondary outcomes:
measure: Treatment strategies for CML and SPM at their occurrence
timeFrame: At the occurence of SPM. Through study completion, on average 20 years
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References:
citation: Preudhomme C, Guilhot J, Nicolini FE, Guerci-Bresler A, Rigal-Huguet F, Maloisel F, Coiteux V, Gardembas M, Berthou C, Vekhoff A, Rea D, Jourdan E, Allard C, Delmer A, Rousselot P, Legros L, Berger M, Corm S, Etienne G, Roche-Lestienne C, Eclache V, Mahon FX, Guilhot F; SPIRIT Investigators; France Intergroupe des Leucemies Myeloides Chroniques (Fi-LMC). Imatinib plus peginterferon alfa-2a in chronic myeloid leukemia. N Engl J Med. 2010 Dec 23;363(26):2511-21. doi: 10.1056/NEJMoa1004095.
Clinical trial NCT01441778: Efficacy of Buffered Hypertonic Saline(BHS)Nasal Irrigation in Allergic Rhinitis (AR) Children
Official title: Efficacy of Buffered Hypertonic Saline Nasal Irrigation in Children With Symptomatic Allergic Rhinitis : A Randomized Double-blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: nasal irrigation
allergic rhinitis
children
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 81
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether buffered hypertonic saline (BHS) is superior to normal saline (NSS) for improving mucociliary function and relief nasal symptoms in children with allergic rhinitis.

Detailed description: 1. BHS is superior to NSS for improving mucociliary function that by measure saccharine clearance time(SCT)at 10 minute after nasal irrigation compare to baseline.
2. BHS is superior to NSS for clinical effectiveness at short period and 1 month follow up

   * at short period: compare the following results at baseline and 10 minute after nasal irrigation

     1. total nasal symptom score(TNSS)
     2. satisfaction to nasal irrigation
     3. side effect
   * at 2 and 4 weeks follow up : compare the following results at baseline and 10 minute after nasal irrigation

     1. quality of life(by specific questionnaire for Thai allergic rhinoconjunctivitis patient)
     2. medication use to relieve AR symptom(from diary record)
     3. compliance for nasal irrigation (from diary record)
     4. side effect (from diary record)
     5. overall satisfaction to nasal irrigation

Eligibility criteria: Inclusion Criteria:

1. age 6-15 years
2. diagnosed AR obtained by history, physical examination and positive skin prick test or nasal cytology
3. TNSS ≥ 4 at the first visit of this study

Exclusion Criteria:

1. Patients with a history of nasal anatomical defects
2. Abnormal nasal ciliary function or an upper respiratory tract infection in the preceding 2 weeks

Primary outcomes:
measure: The change from baseline in SCT at 10 minute after nasal irrigation of BHS and NSS
timeFrame: baseline, 10 minute after nasal irrigaiton
Secondary outcomes:
measure: The effect of BHS and NSS on clinical effectiveness
timeFrame: 1st visit, 2nd week and 4 week follow up
Other outcomes:
Locations:
city: Klong luang
country: Thailand
facility: Araya Satdabudha
state: Pratumthanee
Study officials:
affiliation: Thammasat University
name: Araya Satdhabudh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06312878: CT Features of Interrupted Inferior Vena Cava With Azygous Continuation
Official title: CT Features of Interrupted Inferior Vena Cava With Azygous Continuation : a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anatomical Variant of the Inferior Vena Cava
Keywords: Interrupted vena cava
Azygous continuation
Polysplenia
CT scan
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 15
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: Patients with interrupted IVC with azygous continuation on CT scan

Brief summary: Inferior vena cava (IVC) is the largest vein is the body, draining blood from the abdomen, pelvis and lower extremities. IVC anomalies can be congenital or acquired.

The origins of these anomalies are not entirely clear, and their incidence is uncertain.

Imaging plays a pivotal role in diagnosis to prevent misinterpretation. CT scan is a quick, available, and suitable imaging modality in emergency setting.

The aim of this retrospective monocentric study was of describe CT features of interrupted suprarenal inferior vena cava with azygous continuation.


Eligibility criteria: Inclusion Criteria:

* All patients with interrupted IVC with azygous continuation on CT scan were included in this study.

Exclusion Criteria:

* Patients under 18 years of age
* Patients no available CT scan.

Primary outcomes:
measure: Describe CT features of interrupted suprarenal inferior vena cava with azygous continuation
timeFrame: Day : 1
Secondary outcomes:
measure: Describe CT features of interrupted suprarenal inferior vena cava with azygous continuation
timeFrame: Day : 1
measure: Describe association with polysplenic syndrome
timeFrame: Day : 1
measure: Describe association with polysplenic syndrome
timeFrame: Day : 1
measure: Describe association with polysplenic syndrome
timeFrame: Day : 1
measure: Describe association with polysplenic syndrome
timeFrame: Day : 1
measure: Describe association with polysplenic syndrome
timeFrame: Day : 1
measure: Describe association with polysplenic syndrome
timeFrame: Day : 1
measure: Describe circumstances of discovering the interrupted IVC
timeFrame: Day : 1
measure: Describe circumstances of discovering the interrupted IVC
timeFrame: Day : 1
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Sylvain GRANGE, MD
role: PRINCIPAL_INVESTIGATOR
References: