louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06116318: A Study of c-Kit Mutation as MRD in Acute Myeloid Leukemia
Official title: Absolute Quantification of c-Kit Mutation as MRD in Acute Myeloid Leukemia: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: C-KIT Mutation
Keywords: Acute myeloid leukemia
c-Kit mutation
MRD
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute myeloid leukemia confirmed by bone marrow cell morphology, immunology, and genetics. And c-Kit D816 mutation was positive.

Brief summary: C-Kit is involved in an essential pathway of disease occurrence and is closely related to the poor prognosis of patients. However, the clinical significance of c-Kit mutation as molecular MRD monitoring is still unclear. What are the differences and advantages of using c-Kit mutation as MRD in prognostic assessment compared with other MRDs (MFC or RUNX1::RUNX1T1) widely used today? Existing data suggest that patients with one positive and one negative MRD results obtained by two different techniques have a higher risk of recurrence than patients with two negative MRD results but a lower risk of recurrence than patients with two positive MRD results. Therefore, can combining multiple MRD markers, including c-Kit mutations, overcome the shortcomings of a single molecular marker as MRD monitoring? Therefore, this project intends to confirm the clinical significance of quantitative detection of c-Kit mutation as MRD in acute myeloid leukemia.


Eligibility criteria: Inclusion Criteria:

Patients who meet the diagnostic criteria(WHO 2016 criteria) of AML and have c-Kit D816 mutation. And receive treatment.

Exclusion Criteria:

Patients with other factors which were considered unsuitable to participate in the study by the investigators

Primary outcomes:
measure: CIR
timeFrame: Within 5 years after treatment
Secondary outcomes:
measure: OS
timeFrame: Within 5 years after treatment
measure: RFS
timeFrame: Within 5 years after treatment
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
Study officials:
References:
Clinical trial NCT06046118: Photobiomodulation in Dry Age Related Macular Degeneration
Official title: Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age-Related Macular Degeneration
Keywords: Age related Macular Degeneration
Photobiomodulation
Lead sponsor: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in dry age-related macular degeneration (AMD). The main questions it aims to answer are:

* Is Yellow and Red Light Emitting Diode photobiomodulation effective in decreasing drusen volume in patients affected by dry AMD?
* Does Yellow and Red Light Emitting Diode photobiomodulation increase visual acuity and contrast sensitivity in patients affected by dry AMD? Participants will be randomly assigned to a treatment or a sham group.

Treatment consists in two cycles with two phases each:

* 1st phase: 300 seconds of continuous Yellow light with eyes closed + 60 seconds of pulsed Yellow light with eyes opened;
* 2d phase: 300 seconds of continuous Red light with eyes closed + 60 seconds of pulsed Red light with eyes opened.

Cycle 1 consists of 8 sessions (two PBM per week for 4 weeks) and cycle 2 consists of 6 sessions (two PBM per week for 3 weeks).

Researchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry AMD.


Eligibility criteria: Inclusion Criteria:

* BCVA ETDRS \> 40 L ETDRS at 4 meters
* Diagnosis of DRY AMD AREDS grade 2-3
* Ability to communicate well with the investigator and able to understand and comply with the requirements of the study

Exclusion Criteria:

* Concomitant epilepsy
* Neurological diseases
* Psychiatric pathologies
* Herpes virus infections
* Dense cataract
* Pregnancy
* Other significant ocular and/or retinal diseases

Primary outcomes:
measure: Best Corrected Visual Acuity variation
timeFrame: 1 month, 2 months and 4 months after each cycle
measure: Drusen Volume Variation
timeFrame: 1 month, 2 months and 4 months after each cycle
measure: Contrast sensitivity variation
timeFrame: 1 month, 2 months and 4 months after each cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: University of Paris
city: Ferrara
country: Italy
facility: Università degli Studi di Ferrara
city: Napoli
country: Italy
facility: Università degli studi della Campania Luigi Vanvitelli
city: Torino
country: Italy
facility: Università di Torino
city: Ankara
country: Turkey
facility: University of Ankara
city: Koç
country: Turkey
facility: Koç University Hospital
city: Taunton
country: United Kingdom
facility: Earlam and Christopher
Study officials:
References:
Clinical trial NCT02265718: A Study To Evaluate The Difference In iPad-Based Cognitive Video Game (Akili Interactive's Project: EVO) Performance In Amyloid-Positive Versus Amyloid-Negative Healthy Elderly Volunteers
Official title: A Randomized, Double Blind, Placebo Controlled Trial To Study Difference In Cognitive Learning Associated With Repeated Self-administration Of Remote Computer Tablet-based Application Assessing Dual-task Performance Based On Amyloid Status In Healthy Elderly Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Healthy
elderly volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-10-16
Enrollment: 97
Sex: ALL
Minimum age (years): 70
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of the study is to evaluate the difference in learning and performance measures associated with repeated use of an iPad video game (Akili Interactive's Project: EVO) in healthy elderly volunteers based on amyloid status.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females between the ages of 70 and 80.
* Subjects must have BMI of 17.5 to 32 kg/m2 and total body weight \> 110 pounds.
* Acceptable screening MRI and PET scans that pass quality control requirements.

Exclusion Criteria:

* Co-morbid diagnosis of clinically documented Alzheimer's disease; - Significant cognitive impairment;
* MMSE (mini mental state examination) score \<26

Primary outcomes:
measure: divided attention performance
timeFrame: Day 0 - Day 28
Secondary outcomes:
measure: sustained attention, impulsivity and episodic memory
timeFrame: Day 0 - Day 28
measure: perforamce on EVO dual task assessment, TOVA and RAVLT
timeFrame: Day 0 - Day 28
measure: within subject change on EVO, TOVA and RAVLT
timeFrame: Day 0 - Day 28
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Hollywood
country: United States
facility: Broward Research Group
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Kalamazoo
country: United States
facility: Jasper Clinic, Inc.
state: Michigan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03535818: Adjunctive Ganglionated Plexus Ablation in Redo-Pulmonary Vein Isolation
Official title: Adjunctive GP Ablation In Redo-PVI: Paroxysmal Atrial Arrhythmias After Pulmonary Vein Isolation Are Driven By Ectopy-Triggering Left Atrial Ganglionated Plexus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Atrial Fibrillation
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, controlled, prospective study
Primary purpose: TREATMENT

Brief summary: The investigator propose to test the efficacy of adjunctive ET-GP ablation in patients undergoing redo PVI for paroxysmal AF.

Detailed description: Patients with ongoing paroxysmal arrhythmias after pulmonary vein isolation (PVI) for paroxysmal and persistent atrial fibrillation (AF) get incrementally less benefit with redo-PVI. This implies non-pulmonary vein (PV) triggers, which are more challenging to locate. The autonomic nervous system is implicated in the multifactorial pathogenesis of AF but few studies have attempted neural targeting as a therapeutic intervention. We have demonstrated that stimulation of specific left atrial ganglionated plexi (GPs) triggers both AF and atrial ectopy and importantly stimulation of these sites may not induce AV block, the 'conventional' marker used to locate GPs. Having shown that these ectopy-triggering GP (ET-GP) sites are anatomically stable and can be rendered inactive by either ablation at the site or by ablation between the site and the adjacent PV, a single centre study suggests that ET-GP ablation can prevent recurrent AF in some patients.

Eligibility criteria: Inclusion Criteria:

* Males or females eighteen (18) to eighty five (85) years old
* Paroxysmal atrial fibrillation
* Previous pulmonary vein isolation
* Suitable candidate for catheter ablation
* Signed informed consent

Exclusion Criteria:

* Contraindication to catheter ablation
* Presence of a cardiac thrombus
* Valvular disease that is grade moderate or greater
* Any form of cardiomyopathy
* On amiodarone therapy
* Patients who lack capacity
* Active gastrointestinal bleeding
* Active infection or fever
* Renal failure (Creatinine \>200µmol/L)
* Life expectancy shorter than the duration of the trial
* Bleeding or clotting disorders or inability to receive heparin
* Pregnant

Primary outcomes:
measure: Any atrial arrhythmia >30s documented on ECGs
timeFrame: 12 months
Secondary outcomes:
measure: Symptom recurrence requiring repeat ablations
timeFrame: 12 months
measure: Complications
timeFrame: 12 months
measure: Radiofrequency time
timeFrame: Within ablation procedure
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Prapa Kanagaratnam
Study officials:
affiliation: Imperial College London
name: Prapa Kanagaratnam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05687318: A Clinical Trial of the Effectiveness and Safety of Software Assisting Diagnose the Intestinal Polyp Digestive Endoscopy by Analysis of Colonoscopy Medical Images From Electronic Digestive Endoscopy Equipment
Official title: A Clinical Trial of the Effectiveness and Safety of Software Assisting Diagnose the Intestinal Polyp Digestive Endoscopy by Analysis of Colonoscopy Medical Images From Electronic Digestive Endoscopy Equipment, a Prospective, Multicenter, Randomized Stratified Block, Incomplete Blind Setting, Parallel Sequential Control, and Efficacy Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Artificial Intelligence
Enteroscope
Intestinal Polyposis, Adenomatous
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: The Second Hospital University of South China
name: Loudi Central Hospital
First posted: 2023-01-18
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: A clinical trial of the effectiveness and safety of intestinal polyp digestive endoscopy-assisted diagnosis software used in the analysis of colonoscopy medical images generated by electronic digestive endoscopy equipment.


Eligibility criteria: Inclusion Criteria:

* Age of 18 to 85 years old, regardless of gender;
* electronic colonoscopy is required;
* The subjects or their legal representatives could understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent.

Exclusion Criteria:

* (1) Contraindications associated with electronic colonoscopy or biopsy;
* (2) poor intestinal preparation;
* (3) diagnosed colorectal cancer, familial polyposis, or complicated with known colorectal polyps;
* (4) serious neurological diseases or dysfunction of vital organs (heart, lung, liver, kidney);
* (5) acute abdominal or intestinal inflammation;
* (6) History of abdominal, pelvic, anal and perianal operations within 2 months before enrollment;
* (7) Participated in other interventional clinical trials within 1 month before enrollment;
* (8) In the interest of subjects, the investigator considers that they should not participate in other conditions of the clinical trial.

Primary outcomes:
measure: PMR
timeFrame: during colonoscopy procedure
Secondary outcomes:
measure: AMR
timeFrame: during colonoscopy procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04878913: Retrospective Evaluation of Lung Pathology in Subjects With COVID-19
Official title: Non-interventional, Retrospective, Multicenter, Follow-up Study Evaluating the Effect of C21 on Lung Pathology in Subjects Previously Hospitalized With COVID-19 and Enrolled in the VP-C21-006 Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
COVID-19 Pneumonia
Lead sponsor: Vicore Pharma AB
Sponsor class: INDUSTRY
First posted: 2021-05-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who were previously hospitalized with COVID-19 and enrolled in the VP-C21-006 trial.

Brief summary: Non-interventional, retrospective, multi-center, follow-up study evaluating the effect of C21 on lung pathology in subjects previously hospitalised with COVID-19 and enrolled in the VP-C21-006 trial.

Detailed description: The study will collect available HRCT scans obtained prior to, during treatment with C21 or placebo and up to 24 weeks after trial completion.

HRCT scans will be assessed for ground glass opacity, reticulation, band opacity, fibrosis and consolidation by a central, blinded HRCT reader.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Previously included in the VP-C21-006 trial and received at least one dose of investigational medicinal product (IMP)
* Available record of at least one HRCT performed within 24 weeks after completion of VP-C21-006.

Exclusion Criteria:

* Participation in another interventional trial during the historical period covered by this study that could interfere with the study objectives or evaluation

Primary outcomes:
measure: Averaged total lung score for both lungs percent measured by per lung percent scores
timeFrame: Up to 24 weeks after completion of VP-C21-006
measure: Change from baseline in percent lung involvement measured totally (averaged total lung score for both lungs percent) and by each of ground glass opacity, reticulation, band opacity, fibrosis, and consolidation on follow-up HRCT
timeFrame: Up to 24 weeks after completion of VP-C21-006
Secondary outcomes:
Other outcomes:
Locations:
city: Ahmadabad
country: India
facility: Department of Medicine, Civil Hospital and B J Medical College
state: Gujarat
city: Vadodara
country: India
facility: First Floor Clinical Research Department Rhythm Heart Institute
state: Gujarat
city: Nagpur
country: India
facility: Department of Medicine, Government Medical College and Hospital
state: Maharashtra
city: Pune
country: India
facility: Department of Medicine, Noble Hospitals Pvt. Ltd
state: Maharashtra
Study officials:
affiliation: Vicore Pharma
name: Rohit Batta, MD
role: STUDY_DIRECTOR
References:
citation: Tornling G, et al. The angiotensin type 2 receptor agonist C21 restores respiratory function in COVID19 - a double-blind, randomized, placebo-controlled Phase 2 trial, medRxiv, 2021
Clinical trial NCT05410613: Combined Electromagnetic Field and a Plantar Resistance Exercise With Venous Leg Ulcer
Official title: Effect of Combined Electromagnetic Field and a Plantar Resistance Exercise on Healing of Venous Leg Ulcer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study will investigate the effects of combined electromagnetic field and a plantar resistance exercise therapy versus electromagnetic field on healing of venous leg ulcer .


Eligibility criteria: Inclusion Criteria:

patients with venous leg ulcer

Exclusion Criteria:

patients who have one or more of the following conditions:

* peripheral vascular disease (PVD), (ABPI\<0.8).
* venous leg ulcers with cellulitis or infection symptoms, as well as venous leg ulcers with necrotic tissue or slough or had more than one ulcer.
* other types of ulcers, such as rheumatoid vasculitis, diabetic foot, and malignant ulceration; corticosteroids use ; patients with dementia or who were disoriented;
* undertaken another physical therapy modality for ulcer healing.

Primary outcomes:
measure: Ulcer surface area
timeFrame: two months
measure: Ulcer volume measurement
timeFrame: two months
measure: Pressure Ulcer Scale for Healing (PUSH)
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Surgical department-Mansoura Health Insurance Hospital
Study officials:
affiliation: Surgical department-Mansoura Health Insurance Hospital
name: ASMAA FAWZY EL-SAYED, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01931813: METHORIVAC - Vaccinal Pharmacoepidemiologic
Official title: Pharmacoepidemiological Methodology to Evaluate the Vaccination Risk in Young Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infants Likely to Present Febrile Convulsions
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children of less than 3 years hospitalized for febrile convulsions

Brief summary: This project is the pilot step necessary to develop a system of vaccination pharmacoepidemiology that associates a sophisticated analytical approach, appropriate for this challenge and case series analysis, with the use of linked medicoadministrative data for hospitalisations the reimbursement of healthcare costs. This linkage of medicoadministrative data is new in France. The example of the risk of hospitalisation for febrile convulsions in infants less than two years old following vaccination against diphtheria, tetanus and pertussis is given as the reference association. This choice is justified by the numerous publications over many years on the existence of this association (Miller et al BMJ 1981, Farrington et al Lancet 1995). In addition, as case series analyses have been carried out to assess this risk, the results can be compared directly (Lancet 1995). The study to determine whether the analysis tools are suitable for the data will be tackled at the following levels:

* Validity of the selection of cases from administrative records alone using coding based on the international classification of diseases ICD10
* Validity of the risk assessment. This methodology feasibility project must make it possible to identify the different potential problems. This is a prerequisite necessary for the systematic implementation.


Eligibility criteria: Inclusion Criteria:

- For reimbursement data: All of the data concerning delivery (purchase of the vaccine at a pharmacy, prescription) and vaccination (consultation following the date of purchase) for infants younger than 2 years old, in the years 2007 and 2008.

- For PMSI data: All of the hospitalisations in 2007 and 2008 for febrile convulsions in infants less than 3 years old in hospitals of the following departments: Côte d'Or, Doubs and Bas-Rhin

Exclusion Criteria:

-

Primary outcomes:
measure: DATA EXTRACTION
timeFrame: At the selection of patients
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
Study officials:
References: